As filed with the Securities and Exchange Commission on May 25, 201220, 2013

Registration Statement File No. 333-180691333-188498

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549



 

AMENDMENT NO.Amendment No. 1 TO

to
FORM S-1

REGISTRATION STATEMENT
UNDER THE SECURITIES ACT OF 1933



 

AspenBio Pharma,Venaxis, Inc.

(Exact name of registrant as specified in its charter)



  
Colorado 2835 84-1553387
(State or other jurisdiction of
incorporation or organization)
 (Primary Standard Industrial
Classification Code Number)
 (I.R.S. Employer
Identification Number)

1585 South Perry Street
Castle Rock, CO 80104
(303) 794-2000

(Address, including zip code, and telephone number,
including area code,
of registrant’s principal executive offices)



 

Stephen T. Lundy
President and Chief Executive Officer
AspenBio Pharma,Venaxis, Inc.
1585 South Perry Street
Castle Rock, CO 80104
(303) 794-2000

(Name, address, including zip code, and telephone number,
including area code, of agent for service)



 

Copies to:

 
Gerald J. Guarcini, Esq.
Mary J. Mullany, Esq.
Ballard Spahr LLP
1735 Market Street, 51st Floor
Philadelphia, PA 19103
Telephone: (215) 665-8500
Facsimile: (215) 864-8999
 Yvan-Claude Pierre,Douglas R. Wright, Esq.
Daniel I. Goldberg, Esq.
Reed SmithFaegre Baker Daniels LLP
599 Lexington Avenue3200 Wells Fargo Center
New York, NY 100221700 Lincoln Street
Denver, CO 80203
Telephone: (212) 521-5400(303) 607-3500
Facsimile: (212) 521-5450(303) 607-3600


 

APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC: As soon as practicable after this Registration Statement becomes effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.o

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.o

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.o

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.o

 
Large accelerated filero Accelerated filero
Non-accelerated filero (Do not check if smaller reporting company) Smaller reporting companyx
(Do not check if smaller reporting company)

 


 
 

TABLE OF CONTENTS

CALCULATION OF REGISTRATION FEE

  
Title of Each Class of Securities to be Registered Proposed Maximum
Aggregate
Offering Price(1)
 Amount of
Registration Fee
Common Stock, no par value per share(2)(3) $17,250,000  $1,976.85 
Underwriters’ Warrants to Purchase Common Stock(4)  0   0 
Common Stock Underlying Underwriters’ Warrants(5)  937,500   107.43 
Total Registration Fee(6) $18,187,500  $2,084.28 
  
Title of Each Class of Securities to be Registered Proposed Maximum
Aggregate Offering
Price(1)
 Amount of
Registration Fee
Common Stock, no par value per share(2)(3) $23,000,000  $3,137.20 
Total Registration Fee $23,000,000  $3,137.20(4) 

(1)Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(o) under the Securities Act of 1933, as amended (the “Securities Act”).
(2)Includes shares of common stock that may be issued upon exercise of a 45-day30-day option granted to the underwritersunderwriter to cover over-allotments, if any.
(3)Pursuant to Rule 416 under the Securities Act, the shares of common stock registered hereby also include an indeterminate number of additional shares of common stock as may from time to time become issuable by reason of stock splits, stock dividends, recapitalizations or other similar transactions.
(4)In accordance with Rule 457(g) under the Securities Act, because the shares of the Registrant’s common stock underlying the underwriters’ warrants are registered hereby, no separate registration fee is required with respect to the warrants registered hereby.Paid on May 9, 2013.
(5)Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(g) under the Securities Act. The warrants are exercisable at a per share exercise price equal to 125% of the public offering price. As estimated solely for these purpose of recalculating the registration fee pursuant to Rule 457(g) under the Securities Act, the proposed maximum aggregate offering price of the underwriters’ warrants is $937,500, which is equal to 125% of $750,000 (5% of $15,000,000).
(6)Previously paid.


The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.


 
 

TABLE OF CONTENTS

The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities under this registration statement until the registration statement filed with the Securities and Exchange Commission becomesis declared effective. This preliminary prospectus is not an offer to sell theseany securities, and we are not soliciting offersan offer to buy these securities in any state where the offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED MAY 20, 2013

PRELIMINARY PROSPECTUS

VENAXIS, INC.

$12,500,000

 
PRELIMINARY PROSPECTUSCommon Stock SUBJECT TO COMPLETIONDATED MAY 25, 2012[GRAPHIC MISSING]

$15,000,000We are offering $12,500,000 of Shares
Common Stock

[GRAPHIC MISSING]

AspenBio Pharma, Inc. is offering shares of itsour common stock, no par value per share.

We expect to effect a reverse split on a 1-for-6 basis immediately prior to the date of this prospectus. Unless indicated otherwise and excluding our historical financial statements included herein, all information in the prospectus has been prepared on a pro forma basis that assumes a 1-for-6 reverse split of our issued and outstanding shares of common stock, options and warrants.

stock. Our common stock is quoted on the NASDAQ Capital Market under the trading symbol “APPY.” On May 24, 2012, theThe last reported sale price of our common stock on May 16, 2013, as reported by the NASDAQ Capital Market, was $0.64$1.68 per share, or $3.84 per share after giving effect to the anticipated 1-for-6 reverse stock split.share.

Investing in our common stock involves a high degree of risk. SeePlease read carefully the section entitled “Risk Factors” beginning on page 85 of this prospectus for a discussion of information that should be considered before investing in our common stock.

prospectus.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved the securities described herein or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

  
 Per Share Total
Public offering priceOffering Price $  $ 
Underwriting discountsDiscounts and commissions(1)Commission $  $ 
Proceeds before expenses, to AspenBio Pharma, Inc.Us, Before Expenses $  $ 

(1)The underwriters will receive compensation in addition to the underwriting discount. See “Underwriting” beginning on page 65 of this prospectus for a description of compensation payable to the underwriters.

We have granted the underwriters an optionunderwriter the right, exercisable within a 30-day period, to purchase up to an additional $1,875,000 of shares of our common stock from us atsolely to cover over-allotments. If the public offering price, lessunderwriter exercises its over-allotment right in full, the total underwriting discounts and commissions within 45 days frompayable by us will be $    , and the datetotal proceeds to us, before expenses, will be $    .

We have agreed to reimburse the underwriter for fees incurred by it in connection with this offering, up to a maximum amount of $150,000. See “Underwriting” beginning on page 65 of this prospectus, to cover over-allotments of the shares, if any.prospectus.

The underwriters expectunderwriter expects to deliver our shares to purchasers in the offering on or about            , 2012.2013.

Aegis Capital CorpPiper Jaffray


The date of this prospectus is           , 2012Prospectus dated             2013.


 
 

TABLE OF CONTENTS

[GRAPHIC MISSING]


TABLE OF CONTENTS

TABLE OF CONTENTS

Please read this prospectus carefully. It describes our business, our financial condition and results of operations. We have prepared this prospectus so that you will have the information necessary to make an informed investment decision.

You should rely only on the information contained in this prospectus.prospectus or in any free writing prospectus we may authorize to be delivered or made available to you. We have not authorized anyone to provide you with different information. If anyone provides you with different or inconsistent information, you should not rely on it.We are offering to sell, and seeking offers to buy, shares of our common stock only in jurisdictions where offers and sales are permitted. The information contained in this prospectus is accurate only onas of the date of this prospectus. Our business, financial condition, resultsprospectus, regardless of operations and prospects may have changed since such date. Other than as required under the federal securities laws, we undertake no obligation to publicly update or revise such information, whether as a resulttime of new information, future eventsdelivery of this prospectus or any other reason.sale of shares of our common stock.

For investors outside the United States:

Neither we nor any of We have not and the underwritersunderwriter has not done anything that would permit this offering or possession or distribution of this prospectus or any free writing prospectus we may provide to you in connection with this offering in any jurisdiction where action for that purpose is required, other than in the United States. You are required toPersons outside the United States who come into possession of this prospectus must inform yourselvesthemselves about, and to observe any restrictions relating to, thisthe offering of the shares of common stock and the distribution of this prospectus and any such free writing prospectus outside of the United States.

i


 
 

TABLE OF CONTENTS

PROSPECTUS SUMMARY

This summary highlights information contained elsewhere in this prospectus. This summary does not contain all of the information that you should consider before making an investment decision with respect toinvesting in our securities. You should read this entire prospectus includingcarefully, especially the “Risk Factors” section beginning on page 85 of this prospectus and our financial statements and the related notes contained inappearing at the end of this prospectus, before making an investment decision with respect to our securities. Please see the risk factors following the heading “Risks Related to Our Proposed Reverse Stock Split”decision.

As used in the section of this prospectus, titled “Risk Factors.” Please see the section titled, “Where You Can Find More Information,” beginning on page 73 of this prospectus. Unlessunless the context indicates otherwise requires, references to “Company” or “AspenBio” or “we,” “us” or “our” refers“us,” “our,” “Venaxis” and “the Company” refer to AspenBio Pharma,the operations of Venaxis, Inc.

AspenBio Pharma, Inc.

Business Overview

AspenBio Pharma, Inc.Venaxis is focused on advancing products that address unmet human diagnostic and animal health therapeutic needs. AspenBio wasWe were formed in August 2000 as a Colorado corporation to produce purified proteins for diagnostic applications. WeTo date, we have leveraged our science and technology to advance development of ourAPPY1 product candidate and to develop animal health-related assets, including intellectual property. In 2012, we out-licensed these animal health-related assets and changed our name to Venaxis, Inc. from AspenBio Pharma, Inc.

Our business strategy is to focus on products and technologies that we believe have attractive worldwide markets and significant product margin potential. Our acute appendicitis test,APPY1, which is our current primary focus, meets these objectives. We may also pursue technologies under “in-licensing” agreements with third parties such as universities, researchers or individuals, add value by advancing the stage of research and development on the technologies through proof of concept, and then either “out-license” to global diagnostic companies or continue with in-house development towards regulatory approval, product introduction and launch.

APPY1 is a number of product candidates.

We are developing amulti-marker blood test AppyScoreTM, that ispanel intended to be used by emergency department physicians to aid them in the rule out decisionevaluation of possible acute appendicitis in children, adolescent and young adult patients (ages 2 – 20) patients thatwho present with abdominal pain.APPY1 is under the regulatory jurisdiction of the FDA. We are not aware of noany blood test that is cleared by the Food and Drug Administration (FDA)FDA for the purpose of aiding in the ruling out of appendicitis, and are not aware of any current competitors in this area. We expect the mainthat a principal benefit of AppyScoreAPPY1 will be to provide the physicianphysicians with objective information that will aid in the identification of patients at low risk for appendicitis, and thereby potentially reducingreduce the number of expensiveexposure to radiation from, and potentially hazardousthe expense associated with, computed tomography (CT) scans that are currentlyoften performed on these patients. In addition, we believe the test willcan potentially save significant costs through both the reduction of CT scans and improved patient throughput in crowded emergency departments. We arehave completed a design freeze for ourAPPY1 product candidate and, in early 2013, commenced a 2,000 patient, multi-center prospective pivotal clinical trial to be used in connection with our application for FDA clearance. We also have commenced initial marketing and commercialization activities for our CE markedAPPY1 products in the final stagesEuropean Union.

Recent Developments

European Distribution Agreements.  We have entered into commercial development agreements with a number of diagnostic test distributors in Italy, Turkey and the Benelux countries, and are pursuing commercial development and intend to commence an FDA pivotal trialagreements with such distributors in the summerU.K., France and Germany. Under these commercial development agreements, we are working to roll out our market development program forAPPY1, including identification of 2012initial hospitals and potentially commence marketing AppyScore outside the United Stateskey opinion leaders in the second half of 2012.

Data obtained from the Centers for Disease Control and Prevention (CDC) Public-use Data Files (1973 – 2009) indicates that over 9.5 million total patients visited U.S. hospital emergency departmentsEuropean territories in 2009 with the primary complaint being abdominal pain. Over 3.1 million of these patients went on to receive a CT scan. Approximately 300,000 cases of appendicitis were indicated.which we are focused. Our research indicates that a significant reason for ordering the CT scanstrategy is to aidleverage the experience of key opinion leaders in the ruleselect hospitals in or rule out of appendicitis. In 2007, the New England Journal of Medicine published a study which concluded that CT scans confer a significant increase of cancer risk, particularly when administeredorder to young patients. Physiciansgenerate additional meaningful, multinational field data forAPPY1 products. We have received initial stocking orders for ourAPPY1 products under these relationships.

Building Mortgage Refinancing.  On May 9, 2013, we have surveyed have indicated that a blood test to aid them as they evaluate patients suspected of appendicitis would have great value.

The AppyScore test currently under development employs three biomarkers; (1) our previously patented MRP- 8/14, also known as S100/A8/A9 or calprotectin, (2) C-Reactive Protein (CRP) and (3) White Blood Cell Count (WBC). The individual biomarkers are calculated and entered into a mathematical algorithmDebt Modification Agreement (the Modification Agreement) with FirstBank (the Bank) to refinance an outstanding mortgage loan with the Bank for which calculates the AppyScore.remaining principal balance of approximately $1.6 million was due in July 2013. The results are displayed onModification Agreement extends the displaymaturity date to April 2018 and reduces the interest rate to a fixed interest rate of 3.95% from a variable rate equal to 1% over The Wall Street Journal Prime Rate (with a minimum rate of 7%). The loan terms include a payment amortization period of fifteen years, with a balloon maturity at five years with monthly payments of approximately $11,700. The portion of the AppyScore reader, which is a small bioanalyzer or instrument. The test is designed to be run in approximately 20 minutes by trained laboratory personnel, with the results being reported back to the emergency department physician to assist triaging the patient to a more conservative management route, or possibly a CT scan and other imaging studies or consultation with a surgeon.

In 2011, we conducted a pilot study of the AppyScore multi-marker test in 11 hospitals in the United States and enrolled 503 patients between the ages of 2 through 20. The pilot study evaluated the use of multiple biomarkers for the AppyScore test configuration and demonstrated appreciably better results than the single-marker test evaluated in our previous studies. Based upon the pilot study, the panel for AppyScore wasbuilding mortgage


1


 

TABLE OF CONTENTS

determined to comprise three biomarkers;guaranteed by the Company’s patented MRP 8/14 biomarker and CRP, along with WBC. The concentration in blood or plasma of each of these components was measured and the results analyzed using a proprietary algorithm.

The following data,U. S. Small Business Administration (SBA), which was presented March 16 – 17, 2012, at the West Region meeting held in Las Vegas, NV, and March 21, 2012 at the Northeastern Region meeting held in Springfield, MA,is approximately 34% of the Society for Academic Emergency Medicine (SAEM) summarizecurrent loan total, remains unaffected by the resultsModification Agreement.

Board Appointment.  Effective May 1, 2013, Stephen A. Williams, M.D., Ph.D., the Chief Medical Officer at SomaLogic, Inc., joined our Board of Directors. Dr. Williams has significant experience in diagnostic imaging and biomarker discovery.

Risk Factors

Our business is subject to numerous risks and uncertainties. We face many risks inherent in our business and our industry generally, including the risks and uncertainties described below. You should carefully consider all of the pilot study:

AppyScore Multi-Marker Study Result95% Confidence Interval
Sensitivity96.5%92.1 – 98.5
Specificity43.2%38.2 – 48.3
NPV96.9%92.9 – 98.7

The study data demonstrated high sensitivityinformation set forth in this prospectus and, high negative predictive value (NPV) similar to other adjunctive tests currently used by physicians to aid them in ruling out diseases. These performance attributes should provideparticular, the physician with incremental diagnostic information that we believe will enhance their decision-making process when it comes to evaluating possible appendicitis. By way of example, with an NPV of 96.9%, the physician could be 96.9% confident that the patient did not have the disease, based upon these results. The potential value of the AppyScore test is its ability to aid a physician in his evaluation of ruling out appendicitis to pursue a more conservative treatment path. The AppyScore’s study results are in line with other in vitro diagnostic tests approved for and currently in use in the market today to assist clinicians in their rule out of disease conditions. Clinicians interviewed have indicated that this performance would be helpful to them in managing patients suspected for appendicitis. It would enable them to use the test to assist in the evaluation of appendicitis, and potentially decrease their overall use of CT scans.

We plan to finalize the conversion of the AppyScore from a single marker test to a multi-marker reader cassette system blood test and submit a pre-investigational device exemption (pre-IDE) application to the FDA in the second quarter of 2012. This submission is intended to document the planned regulatory path for AppyScore, which we believe to be de-Novo 510(k), as well as achieve agreement on the statistical analysis plan and protocol for the clinical trial. This would be followed by the commencement of a pivotal clinical trial, which we expect would be concluded in the first quarter of 2013. Following the conclusion of the trial, we plan to submit the trial results to the FDA and, if successful, launch the product in the United States after FDA clearance. We intend to file for a conformity mark for product conformity under the European Economic Area (CE mark)heading “Risk Factors,” prior to making an investment in our securities. Among these important risks are the following:

We are currently a single product company that is heavily dependent on the successful development and commercialization of theAPPY1 product, and if we encounter delays or difficulties in the development of this product, our business could be harmed.
If we fail to obtain FDA clearance, which we expect to proceed under a 510(k)de novo classification path, we cannot market our product in the United States.
We will need substantial additional funding to develop our products and for the product in the third quarter of 2012 which would potentially enable us to initiate marketing of AppyScore in the European Union, where a pivotal trial is not required.

our future operations. If we are unable to obtain FDA clearancethe funds necessary to do so, we may be required to delay, scale back or approval, we plan to commercialize the product in the United States through a small direct sales organization, supplemented by distributors as necessary. The primary revenue will be generated through the sale of disposable cassettes which are run separately for each patient. We anticipate the AppyScore instrument will be moderately-priced and are exploring options to either sell or lease the instrument to the hospitals. We expect to market the product outside the United States through either a network of specialized distributors or partners.

Beginning in 2004, we initiated the establishment of an intellectual property portfolio for AppyScore. Ongoing scientific and technical progress remains the basis foreliminate our patenting efforts. Since March 2009, three U.S. patents have been issued and one foreign patent has been allowed. At this time, additional foreign patent applications have been allowed or are pending. On November 16, 2011, an additional provisional patent application was filed which focuses on the newly developed multiple-marker technology. Currently, this filing is a provisional patent and has not yet filed or granted in any specific countries.

Our animal health product development efforts are directed toward the creation of reproduction drugs for the enhancement of animal fertility. The initial focus is for use in the cattle industry,activities or may be unable to be followed by other livestock species of economic importance.

continue our business.
We have very limited sales and marketing experience and limited sales capabilities, which may make commercializing our products difficult.

2


TABLE OF CONTENTS

Company Information

We were organized as a Colorado corporation on July 24, 2000. Our principal executive offices are located at 1585 S. Perry Street, Castle Rock, COColorado 80104. Our phone number is (303) 794-2000 and our facsimileInternet address is (303) 798-8332. We maintain a website atwww.aspenbiopharma.comwww.venaxis.com. The information on our website or any other website is not incorporated by reference intoin this prospectus and does not constitute a part of this prospectus.

Risks

We are developing a medical device product and have no significant revenues, and, as such, face significant uncertainty regarding our future capital needs, timelines for and success of our intended products. We have experienced significant recurring losses from operations and negative cash flows from operations. Our business and our ability to execute our business strategy are subject to a number of risks of which you should be aware before you decide to buy our common stock. In particular, you should carefully consider the following risks, which are discussed more fully under “Risk Factors” beginning on page 8 of this prospectus.

Our independent registered public accounting firm added an emphasis paragraph to their audit report describing an uncertainty related to our ability to continue as a going concern.
If we fail to obtain FDA clearance, which we expect to proceed under a 510(k) de-Novo Classification path, we cannot market our product in the United States.
The successful development of a medical device such as our acute appendicitis test is highly uncertain and requires significant financial expenditures and time.
Clinical trials for our products are expensive and we cannot assure you that we will be able to complete our clinical trial programs successfully within any specific time period, or if such clinical trials take longer to complete than we project, our ability to execute our current business strategy will be adversely affected.
We face competition in the biotechnology and pharmaceutical industries and new diagnostic tests and new animal treatments which may be developed by others could impair our ability to maintain and grow our business and remain competitive.
Failure to obtain medical reimbursement for our products under development, as well as a changing regulatory environment, may impact our business.
We have very limited sales and marketing experience and limited sales capabilities, which may make commercializing our products difficult.
If we successfully obtain FDA clearance or approval to market our acute appendicitis tests, we may experience manufacturing problems resulting in shortages or delays in production that could limit the near term growth of our revenue.
Our results of operations could be affected by our royalty payments due to third parties.
Our success depends on our ability to successfully develop, obtain clearance or approval for and commercialize new products.
Our success will depend in part on establishing and maintaining effective strategic partnerships and business relationships with third parties.
If we fail to obtain regulatory approval in foreign jurisdictions, then we cannot market our products in those jurisdictions.
We may be unable to retain key employees or recruit additional qualified personnel.
Our product liability insurance coverage may not be sufficient to cover claims.
Our competitive position is contingent upon the production of our intellectual property and we may not be able to withstand challenges to our intellectual property rights.

3


 

TABLE OF CONTENTS

We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights and we may be unable to protect our rights to, or use of, our technology.
Obtaining and maintaining our patent protection depends upon compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
Our failure to secure trademark registration could adversely affect our ability to market our product candidates and our business.
Confidentiality agreements with employees and others may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protect our intellectual property, which could impede our ability to compete.
We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
We may not be able to adequately protect our intellectual property outside of the United States.
While our common stock currently trades on the NASDAQ Capital Markets Exchange, our share price is below NASDAQ’s $1.00 minimum bid price rule, which could subject our shares to de-listing.
While our common stock currently trades on the NASDAQ Capital Markets Exchange, our total stockholders’ equity is below NASDAQ’s $2.5 million minimum, which could subject our shares to de-listing.
We require additional capital for future operations and we cannot assure you that capital will be available on reasonable terms, if at all, or on terms that would not cause substantial dilution to our existing shareholders.
Current challenges in the commercial and credit environment may adversely affect our business and financial condition.
We do not anticipate paying any dividends in the foreseeable future and, as a result, our investors’ sole source of gain, if any, will depend on capital appreciation, if any.
Our stock price, like that of many biotechnology companies, is volatile.
Management will have broad discretion as to the use of the net proceeds from this offering, and we may not use the proceeds effectively.
A substantial number of shares of common stock may be sold in the market following this offering, which may depress the market price for our common stock.
Investors in this offering will pay a much higher price than the book value of our stock.
Our shareholders have approved a reverse split of our common stock for the purpose of meeting the minimum bid requirement imposed by the NASDAQ Stock Market for continued listing. However, the reverse stock split, ultimately, may not increase our stock price and we may not be able to continue to list our common stock on the NASDAQ Capital Market.
Even if the reverse stock split achieves the requisite increase in our stock price, we cannot assure you that we will be able to comply or continue to comply with the minimum bid price requirement.

The reverse stock split may decrease the liquidity of our stock.

After the reverse stock split, the resulting stock price may not attract new investors, including institutional investors, and may not satisfy the investing requirements of those investors. Consequently, the trading liquidity of our common stock may not improve.

4


TABLE OF CONTENTS

Recent DevelopmentsOffering

Results from our 503-patient pilot study of AppyScore test using multiple markerswere presented March 16 – 17, 2012, at the West Region meeting held in Las Vegas, NV, and March 21, 2012 at the Northeastern Region meeting held in Springfield, MA, of the Society for Academic Emergency Medicine (SAEM). The results were also presented from the podium at the annual meeting of the SAEM, held in Chicago, on May 11, 2012.

As a result of our decision to focus on the human AppyScore test development activities, we are currently advancing in a strategic process to monetize our animal health business and related intellectual property, with the goal of entering into a transaction or license agreement with a third party, most likely a company currently in the industry, who would take over product development and commercialization. Our animal health product development efforts were directed toward the creation of reproduction drugs for the enhancement of animal fertility. The initial focus was for use in the cattle industry, to be followed by other livestock species of economic importance. The cattle therapeutics were sub-licensed in 2008 to Novartis Animal Health (Novartis) under a long-term world-wide development and marketing agreement. In November 2011, following the failure of a pilot study result to meet the defined criteria for success, we and Novartis entered into a termination agreement. The termination agreement provides, subject to agreed upon conditions, including specified payments being made by us, product rights and technology originally licensed to Novartis returns to us.

On May 11, 2012, Erik S. Miller, Vice President of Marketing and Business Development of the Company, resigned.

On May 22, 2012 at the Company’s 2012 Annual Shareholders’ Meeting, the shareholders, among other actions, approved granting authority to the Board of Directors to effect a reverse stock split of the outstanding shares of the Company’s Common Stock in a ratio of at least 1-for-2 and up to 1-for-6 and approval of a corresponding amendment to the Company’s Articles of Incorporation, as amended, subject to the authority of the Board of Directors to abandon such amendment.

On May 23, 2012, Don Hurd was hired and we executed an employment agreement with him for a new position of Senior Vice President and Chief Commercial Officer.

5


TABLE OF CONTENTS

THE OFFERING

Common Stock we are offeringstock offered by us  
  Up to $15,000,000 of shares of common stock ($17,250,000 of shares if the underwriters exercise their over-allotment option).
Offering price
$    per share.
Common stock outstanding prior to this offering
1,609,720 shares.     Shares
Common stock to be outstanding after this offering  
       shares.Shares
Over-allotment option
Up to      shares of common stock. The option is exercisable, in whole or in part, for a period of 30 days from the date of this prospectus.
Use of proceeds  
  We intend to use the net proceeds from this offering for general corporate purposes, including conducting ourfunding for further clinical trialdevelopment, seeking FDA clearance for AppyScore.APPY1, and for initial commercialization of APPY1 in the U.S. and the E.U. See “Use of Proceeds” for additional information.
NASDAQ Capital Market symbol:Risk factors  
  “APPY”You should read the “Risk Factors” section and other information included in this prospectus for a discussion of factors to consider carefully before deciding to invest in shares of our common stock.
Risk FactorsNasdaq Capital Market symbol  
  The securities offered by this prospectus are speculative and involve a high degree of risk. Investors purchasing securities should not purchaseOur common stock is listed on the securities unless they can affordNasdaq Capital Market under the loss of their entire investment. See “Risk Factors” beginning on page 8.symbol “APPY.

Unless indicated otherwise, we have, for purposes of disclosure in the prospectus, assumed consummation of a 1-for-6 reverse stock split immediately prior to the date of this prospectus and have assumed an offering price of $3.84, the closing price of the Company’s common stock on May 24, 2012, as adjusted to reflect the reverse stock split. The number of shares of our common stock to be outstanding after this offering set forth above is based on 9,954,380 shares of our common stock outstanding immediately prior to, and to be outstanding immediately after,as of May 16, 2013.

Unless otherwise indicated, all information in this offering is based onprospectus, including the number of shares of our common stock to be outstanding as of May 24, 2012, and does not includeafter this offering set forth above, excludes the following (in each case giving effect to the anticipated 1-for-6 reverse stock split):following:

238,4811,226,899 shares of common stock issuable upon the exercise of outstanding options granted under our stock option plans at a weighted average exercise price of $45.03$8.94 per share;
48,651597,004 shares of common stock issuable upon exercise of options granted outside of our stock option plans and warrants at a weighted average exercise price of $4.87 per share;
260,306 shares of common stock available for future issuance under our stock option plans; and
296,889     shares of common stock issuable upon exercise of our non-qualified options and warrants, 267,500 of which are exercisable for $7.32 per share and 29,389 of which are exercisable for $13.26 per share;
585,937 shares of common stock issuable uponthe exercise of the underwriters’underwriter’s over-allotment option; and
195,312 shares of common stock underlying the warrants to be issued to the representative of the underwriters in connection with this offering.option.

6


 

TABLE OF CONTENTS

SUMMARY FINANCIAL DATA

The following tables summarize our financial data for the periods presented. The summary statements of operations data for the years ended December 31, 2012, 2011 and 2010 have been derived from our audited financial statements, which are included in this prospectus. The summary statements of operations data for the three months ended March 31, 2013 and 2009,2012 and the balance sheet data as of DecemberMarch 31, 20112013 have been derived from our auditedinterim unaudited financial statements, which are included in this prospectus. The historical results are not necessarily indicative of the results to be expected for any future periods. You should read this data together with the financial statements and related notes included elsewhere in this prospectus, as well as “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the other financial information included elsewhere in this prospectus.

Statements of Operations Data:STATEMENTS OF OPERATIONS DATA:

          
 Three months ended March 31,
(unaudited)
 For the Fiscal Years Ended
December 31,
 For the Fiscal Year Ended
December 31,
 For the Three Months Ended March 31,
 2012 2011 2011 2010 2009 2012 2011 2010 2013 2012
Summary Statement of Operations Items:
                         
Summary Statements of Operations Data:
                         
Total revenues $7,000  $97,000  $219,000  $370,000  $291,000  $42,000  $219,000  $370,000  $  $$7,300 
Net loss $(1,938,000 $(2,806,000 $(10,214,000 $(13,338,000 $(15,518,000 $(9,212,000 $(10,214,000 $(13,338,000 $(2,802,000 $(1,938,000
Basic and diluted loss per share(1)(2) $(1.21 $(2.10 $(7.63 $(10.16 $(14.03
Basic and diluted net loss per share(1)(2) $(1.84 $(7.61 $(10.17 $(0.28 $(1.21
Weighted average shares outstanding(2)  1,605,554   1,338,054   1,338,786   1,312,680   1,105,748   4,996,827   1,341,379   1,310,956   9,954,380   1,608,146 

(1)See “Note 2. Summary of Significant Accounting Policies” of Notes to our Financial Statements for a description of the computation of loss per share.
(2)The basic and diluted net loss per share and weighted average shares outstanding used in the net loss per share calculation have been adjusted to reflect the one-for-five reverse stock split that was effected on July 28, 2011 and has also been adjusted to give pro forma effect to the 1-for-6one-for-six reverse stock split that we intend to effect immediately prior to the date of this prospectus.was effected on June 20, 2012.

Balance Sheet Data:BALANCE SHEET DATA:

    
 As of
March 31,
2012 (unaudited)
 As Adjusted, March 31,
2012(1)
 As of
March 31, 2013
 As Adjusted March 31, 2013(1)
Summary Balance Sheet Information:
                    
Current assets $2,091,000  $15,441,000  $9,554,000  $20,684,000 
Total assets $6,367,000  $19,717,000  $13,594,000  $24,724,000 
Long term liabilities $2,603,000  $2,603,000  $2,001,000  $2,001,000 
Total liabilities $4,257,000  $4,257,000  $5,221,000  $5,221,000 
Total Shareholders’ Equity $2,110,000  $15,460,000 
Total stockholders’ equity $8,373,000  $19,503,000 

(1)As adjusted amounts give effect to the issuance and sale of 3,906,250$12,500,000 of shares of common stock by us in this offering at an assumed initial public offering price of $3.84$1.68 per share, the closing price of our common stock on May 16, 2013, and the application of the net proceeds of the offering, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, as set forth under “Use of Proceeds.” See “Use of Proceeds” and “Capitalization.”

7


 

TABLE OF CONTENTS

RISK FACTORS

An investmentInvesting in our common stocksecurities involves a high degree of risk. Before you decide to invest in our common stock, youYou should carefully consider carefullythe risks described below, together with all of the other information included in this prospectus, or incorporated herein by reference, including the risks described below. Any of these risks could have a material adverse effect on ourbefore making an investment decision. Our business, prospects, financial condition and results of operations.operations could be materially and adversely affected by any of these risks or uncertainties. In any suchthat case, the tradingmarket price of our common stock could decline, and you couldmay lose all or part of your investment. You should also refer

Risks Related to Our Business

We are currently a single product company that is heavily dependent on the successful development and commercialization of the APPY1 product, and if we encounter delays or difficulties in the development of this product, our business could be harmed.

Our success is heavily dependent upon the successful development of theAPPY1 product. Our business could be materially harmed if we encounter difficulties in the development of this product, such as:

delays in the design, enrollment, implementation or completion of the currentAPPY1 clinical trial;
less than desired results of theAPPY1 clinical trial; and
an inability to follow our current development strategy for obtaining regulatory approval from the FDA because of changes in the regulatory approval process.

The commercial success of our products will depend upon the degree of market acceptance by physicians, hospitals, third-party payors, and others in the medical community.

TheAPPY1 product and any other products that we ultimately bring to the other information containedmarket, if they receive approval, may not gain market acceptance by physicians, hospitals, third-party payors or others in this prospectus, including our financial statements and the notes to those statements, and the information set forth under the caption “Forward-Looking Statements.” The risks described below and contained in our other periodic reports incorporated herein by reference aremedical community. If these products do not the only ones thatachieve an adequate level of acceptance, we face. Additional risks not presently known to us or that we currently deem immaterial may also adversely affect our business, prospects, financial condition and results of operations.

Risks Relating to Our Business

Our independent registered public accounting firm added an emphasis paragraph to their audit report describing an uncertainty related to our ability to continue as a going concern.

Due to our continued losses and limited capital resources our independent registered public accounting firm has issued a report that describes an uncertainty related to our ability to continue as a going concern. The auditors’ report discloses that we did not generate significant revenues in 2011, we incurred a net loss of approximately $10,214,000product revenue and we consumed cash in operating activitiesmay not become profitable. The degree of approximately $8,333,000 in 2011. These conditions raise substantial doubt aboutmarket acceptance of our products, if approved for commercial sale, will depend on a number of factors, including:

the efficacy and potential advantages over alternative treatments;
the ability to continue asoffer our products for sale at competitive prices;
the willingness of the target population to accept and adopt our products;
the strength of marketing and distribution support and the timing of market introduction of competitive products; and
publicity concerning our products or competing products and treatments.

Even if a going concernpotential product displays a favorable profile, market acceptance of the product will not be known until after it is launched. Our efforts to educate the medical community and third-party payors on the benefits of our products may require significant resources and may make it difficult for usnever be successful. Such efforts to raise capital. The financial statements do not include any adjustments that might result fromeducate the outcome of this uncertainty.marketplace may require more resources than are required by conventional technologies marketed by our competitors.

If we fail to obtain FDA clearance, which we expect to proceed under a 510(k) de-Novo Classificationde novo classification path, we cannot market our product in the United States. An alternative path, which is longer and more restrictive, would be required. Such a process, called a premarket approval (PMA) would place our product in FDA’s Class III.

Therapeutic or human diagnostic products such as ourAPPY1 test require FDA clearance (or approval (or clearance)or licensing) prior to marketing and sale. This applies to our ability to market, directly or indirectly, our AppyScoreAPPY1 acute appendicitis test. As a new product, this test must undergo lengthy and rigorous development testing and other extensive, costly and time-consuming procedures mandated by the FDA. In order to obtain required FDA clearance we must finalize development of our product, product labeling and successfully complete clinical testing. This process canhas taken, and will continue to take, a substantial amountsamount of time and resources to complete. We may elect to delay or cancel our anticipated regulatory submissions for new indications for


TABLE OF CONTENTS

our proposed new products for a number of reasons. There is no assurance that any of our strategies for obtaining FDA clearance or approval in an expedient manner will be successful, and FDA clearance is not guaranteed. The actual timing of such completion, submission and clearance which cannot be estimated at this point, could also impact our ability to realize market value from such tests.products. If we do achieve FDA clearance or approval, it could subsequently be suspended or revoked, or we could be fined, based on a failure to continue to comply with ongoing regulatory requirements and standards. Similar regulatory approval or ongoing requirements and contingencies will also be encountered in major international markets.

FDA approval is also required prior to marketing and sale for therapeutic products that will be used on animals, and can also require considerable time and resources to complete. New drugs for animals must receive New Animal Drug Application approval. This type of approval is required for the use of our therapeutic equine and bovine protein products. The requirements for obtaining FDA approval are similar to those for human drugs and will require similar clinical testing. Approval is not assured and, once FDA approval is obtained, we would still be subject to fines and suspension or revocation of approval if we fail to comply with ongoing FDA requirements.

If we fail to obtain FDA clearance or approval for our human diagnostic products or our animal health therapeutic products, we will not be able to market and sell our products in the United States. As a result, we would not be able to recover the time and resources spent on research and development of such products.

We have incurred losses since inception, and we expect to incur significant losses in the foreseeable future and may never become profitable.

Since our inception in 2000, we have incurred significant losses and negative cash flows from operations. We incurred net losses of $9,212,000 in 2012, $10,214,000 in 2011 and $13,338,000 in 2010 and $2,802,000 for the three months ended March 31, 2013. As of March 31, 2013, we had an accumulated deficit of $77,035,000, and anticipate incurring additional losses for at least the next several years. In order to achieve profitability, we must develop products and technologies that can be commercialized by us or through our existing or future collaborations. Our ability to generate revenues and become profitable will depend on our ability, alone or with potential collaborators, to timely, efficiently and successfully complete the development of our products. We cannot assure you that we will ever earn revenue or that we will ever become profitable. If we sustain losses over an extended period of time, we may be unable to continue our business.

We expect to continue to incur operating losses at least until 2015. If capital requirements vary materially from those currently planned, we may require additional capital sooner than expected.

We will need substantial additional funding to develop our products and for our future operations. If we are unable to obtain the funds necessary to do so, we may be required to delay, scale back or eliminate our product development activities or may be unable to continue our business.

We have historically needed to raise capital to fund our operating losses, including development expenses. The development of our product candidates will require a commitment of substantial funds to conduct costly and time-consuming research, which may include preclinical and clinical testing, necessary to obtain regulatory approvals and bring our products to market. Net cash used in our operations was $5,489,000 in 2012, $8,333,000 in 2011 and $10,707,000 in 2010, and $2,472,000 for the three months ended March 31, 2013.

At March 31, 2013, we had $9,268,000 of cash, cash equivalents, and short-term investments. While we believe that we have sufficient funds to continue our operations through the completion of our current clinical trial for theAPPY1 product, we expect that we will require additional capital to complete the FDA clearance process forAPPY1and to fund the initial commercialization activities in the U.S. and the E.U. and for future product development, both future generationAPPY1 and other diagnostic products. We cannot be certain that additional capital will be available on acceptable terms or at all. In recent years, it has been difficult for companies to raise capital, especially in light of the state of the current financial markets which could impact the timing, terms and other factors in our attempts to raise capital. To the extent we raise additional capital through the sale of equity securities, the ownership position of our existing shareholders could be substantially diluted and the market price of our common stock could decline.

Failure to successfully address ongoing liquidity requirements will have a material adverse effect on our business. If we are unable to obtain additional capital on acceptable terms when needed, we may be required to take actions that harm our business and our ability to achieve cash flow in the future, including possibly the surrender of our rights to some technologies or product opportunities, delaying our clinical trials or curtailing or ceasing operations.

8



 

TABLE OF CONTENTS

The successful development of a medical device such as our acute appendicitis test is highly uncertain and requires significant financial expenditures and time.

Successful development of medical devices is highly uncertain. Products that appear promising in research or development may be delayed or fail to reach later stages of development or the market for several reasons, including failure to obtain regulatory clearance or approval, manufacturing costs, pricing and reimbursement issues, or other factors that may render the product uneconomical to commercialize. In addition, success in pilot trials does not ensure that larger-scale clinical trials will be successful. Evolutions in development from early stage products to later state products may require additional testing or analysis. Clinical results are frequently susceptible to varying interpretations that may delay, limit, or prevent regulatory approvals. The length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly and may be difficult to predict. If our large-scale clinical trials for a product are not successful, we will not recover our substantial investments in that product.

Factors affecting our research and development productivity and the amount of our research and development expenses include, but are not limited to, the number of patients required to be enrolled, site costs (including site overhead) and the outcome of required clinical trials to be conducted by us and/or our collaborators.

Clinical trialsWe may not be able to successfully launch sales of our products in the European Union countries or elsewhere outside of the U.S.

We obtained CE marking for ourAPPY1 products in January 2013. We have launched initial commercialization and marketing activities in the U.K., Italy, France, Germany, Turkey and the Benelux countries. Our strategy is to leverage the experience of key opinion leaders in select hospitals in such countries in order to generate additional meaningful, multinational field data forAPPY1 products. We may not be able to implement such strategy on a timely basis, and may encounter the uncertainties and delays in adoption that accompany new diagnostic testing alternatives, pricing pressure for our products and difficulties developing the relationships necessary to conduct business outside of the United States. We also will rely on third parties to sell our products internationally. In these instances, our future revenues will be materially dependent upon the success of the efforts of these third parties.

Clinical trials are expensive and we cannot assure you that we will be able to complete our clinical trial programsprogram successfully within any specific time period, or if such clinical trials taketrial takes longer to complete than we project, our ability to execute our current business strategy will be adversely affected.

Conducting clinical trials is a lengthy, time-consuming and expensive process. Before obtaining regulatory approvals for the commercial sale of any products, we or our partners, must demonstrate through clinical trials the safety and efficacyeffectiveness of our products. We have incurred, and we will continue to incur, substantial expense for, and devote a significant amount of time to, product development, pilot trial testing, clinical trials and clinical trials.regulated, compliant manufacturing processes.

Even if completed, we do not know if these trials will produce statistically significant or clinically meaningful results sufficient to support an application for marketing approval. Whether or not and how quickly we complete clinical trials is dependent in part upon the rate at which we are able to obtain regulatory clearance to commence clinical trials, engage clinical trial sites and medical investigators, reach agreement on acceptable clinical trial agreement terms, clinical trial protocols or informed consent forms with medical investigators, clinical trial sites or institutional review boards and, thereafter,advance the rate of patient enrollment, and the rate to collect, clean, lock and analyze the clinical trial database.

Patient enrollment in trials is a function of many factors, including the design of the protocol, the size of the patient population, the proximity of patients to and availability of clinical sites, the eligibility criteria for the study, the perceived risks and benefits of the product candidate under study and of the control, if any, the medical investigator’sinvestigators’ efforts to facilitate timely enrollment in clinical trials, the patient referral practices of local physicians, the existence of competitive clinical trials, and whether other investigational, existing or new products are available or approved for the indication. If we experience delays in identifying and contracting with appropriate medical investigators and site, in patient enrollment and/or/or completion of our clinical trial programs, we may incur additional costs and delays in our development programs, and may not be able to complete our clinical trials on a cost-effective or timely basis. Accordingly, we may not be able to complete the clinical trials within an acceptable time frame, if at all. If we fail to enroll and maintain the number of patients for which the clinical trial was designed, the statistical power of that clinical trial may be reduced, which would make it harder to demonstrate that the product candidate being tested in such clinical trial is safe and effective. Further, if we or any third party have difficulty enrolling a


TABLE OF CONTENTS

sufficient number of patients in a timely or cost-effective manner to conduct clinical trials as planned, or if enrolled patients do not complete the trial as planned, we or a third party may need to delay or terminate ongoing clinical trials, which could negatively affect our business.

Clinical trials often require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit for our clinical trials. Our ability to enroll sufficient numbers of patients in our clinical trials depends on many factors, including the size of the relevant patient population, the nature and design of the protocol, the proximity of patients to clinical sites, the eligibility and exclusion criteria applicable for the trial, existence of competing clinical trials and the availability of already approved effective drugs for the indications being studied. In addition, patients may withdraw from a clinical trial or be unwilling to follow our clinical trial protocols for a variety of reasons. If we fail to enroll and maintain the number of patients for

9


TABLE OF CONTENTS

which the clinical trial was designed, the statistical power of that clinical trial may be reduced which would make it harder to demonstrate that the product candidate being tested in such clinical trial is safe and effective.

We face competition in the biotechnology and pharmaceutical industries and new diagnostic tests, and new animal treatments which may be developed by others, could impair our ability to maintain and grow our business and remain competitive.

We face intense competition in the development, manufacture, marketing and commercialization of diagnostic products such as ours from a variety of sources, such as academic institutions, government agencies, research institutions and biotechnology and pharmaceutical companies, including other companies with similar diagnostic orin vitro testing technologies, including those with platform technologies. These platform technologies vary from very large analyzer systems to smaller and less expensive instruments similar to ours. These competitors are working to develop and market other diagnostic tests, systems, products and other methods of detecting, preventing or reducing disease.

The development of new technologies or improvements in current technologies for diagnosing acute appendicitis, including CT imaging agents and products that would compete with our acute appendicitis test could have an impact on our ability to sell the acute appendicitis tests or the sales price of the tests. This could impact our ability to market theour tests and/or secure a marketing partner, both of which could have a substantial impact on the value of our acute appendicitis products.

Among the many experimental diagnostics and therapies being developed around the world, there may be diagnostics and therapies unknown to us that may compete with our technologies or products.

Many of our potential competitors have much greater capital resources, manufacturing, research and development resources and production facilities than we do. Many of them may also have much more experience than we have in preclinical testing and clinical trials of new diagnostic tests or animal drugs and in obtaining FDA and foreign regulatory approvals.

Major technological changes can occur quickly in the biotechnology and pharmaceutical industries,industry, and the development of technologically improved or different products or technologies may make our product candidates or platform technologies obsolete or noncompetitive.

Our product candidates if successfully developed and approved for commercial sale, will compete with a number of human diagnostic tests or animal drugs currently manufactured and marketed by other biotechnology companies. Our product candidates may also compete with new products currently under development by others or with products which may cost less than our product candidates. Physicians, patients, third party payors and the medical community may be slow to adopt, and may not accept or utilize our acute appendicitis test products when and if approved. If our products, if and when approved, do not achieve significant market acceptance, our business, results of operations and financial condition may be materially adversely affected.

Failure to obtain medical reimbursement for our products under development, as well as a changing regulatory environment, may impact our business.

The U.S. healthcare regulatory environment may change in a way that restricts our ability to market our acute appendicitis tests due to medical coverage or reimbursement limits. Sales of our human diagnostic tests will depend in part on the extent to which the costs of such tests are paid by health maintenance, managed care, and similar healthcare management organizations, or reimbursed by government health payor administration authorities, private health coverage insurers and other third-party payors. These healthcare management organizations and third party payers are increasingly challenging the prices charged for medical products and services. The containment of healthcare costs has become a priority of federal and state governments. Accordingly, our potential products may not be considered to be cost effective, and reimbursement to the consumer may not be available or sufficient to allow us to sell our products on a competitive basis. Legislation and regulations affecting reimbursement for our products may change at any time and in ways that are difficult to predict and these changes may be adverse to us. Any reduction in Medicare, Medicaid or other third-party payer reimbursements could have a negative effect on our operating results.

10


TABLE OF CONTENTS

We have very limited sales and marketing experience and limited sales capabilities, which may make commercializing our products difficult.

We currently have very little marketing experience and limited sales capabilities. Therefore, in order to commercialize our products, once approved, we must either develop our own marketing and distribution sales capabilities or collaborateconsider collaborating with a third party to perform these functions. We may, in some instances, rely significantly on sales, marketing and distribution arrangements with collaborative partners and other third parties. In these instances, our future revenues will be materially dependent upon the success of the efforts of these third parties.

We may not be able to attract and retain qualified personnel to serve in our sales and marketing organization, to develop an effective distribution network or to otherwise effectively support our commercialization activities. The cost of establishing and maintaining a sales and marketing organization may exceed its cost effectiveness. If we fail to develop sales and marketing capabilities, if sales efforts are not effective or if costs of developing sales and marketing capabilities exceed their cost effectiveness, our business, results of operations and financial condition would be materially adversely affected.


TABLE OF CONTENTS

If we successfully obtain FDA clearance or approval to market our acute appendicitis tests,test, we (or our vendors) may experience manufacturing problems resulting in shortages or delays in production that could limit the near term growth of our revenue.

Our ability to successfully market the acute appendicitis test, once approved, will partially depend on our ability to obtain and manufacture sufficient quantities of the finished tests from qualified GMP suppliers. While we have identified and are progressing with qualified suppliers, their ability to produce tests or component parts in sufficient quantities to meet possible demand may cause delays in securing products or could force us to seek alternative suppliers. The need to locate and use alternative suppliers could also cause delivery delays for a period of time. Delays in finalizing and progressing under agreements with cGMP facilities may delay our FDA approvalclearance process and potentially delay sales of such products. In addition, we may encounter difficulties in production due to, among other things, the inability to obtain sufficient amounts of raw materials, components or finished goods inventory and quality control issues with raw materials, components or finished goods. These difficulties could reduce sales of our products, increase our costs, or cause production delays, all of which could damage our reputation and hurt our financial condition. To the extent that we enter into manufacturing arrangements with third parties, we will depend on them to perform their obligations in a timely manner and in accordance with applicable government regulations.

We may not achieve future revenue from the out-licensing of our animal health assets.

In 2012, we entered into an exclusive license agreement with a third party to license all of our animal health assets in return for license fees, milestone and royalty payments. If product development efforts using our animal health assets are not successful in achieving commercial products, we may not receive all anticipated milestone and royalty payments.

Our results of operations could be affected by our royalty payments due to third parties.

Any revenues from products under development will likely be subject to royalty payments under licensing or similar agreements. Major factors affecting these payments include, but are not limited to:

coverage decisions by governmental and other third-party payors;
our ability to achieve meaningful sales of our products;
the achievement of milestones established in our license agreements; and
our use of the intellectual property licensed in developing the products.

If we need to seek additional intellectual property licenses in order to complete our product development, our cumulative royalty obligations could adversely affect our net revenues and results of operations.

Our success depends on our ability to successfully develop, obtain clearance or approval for and commercialize new products.

Our success depends on our ability to successfully develop and market new products. Although we were engaged in human diagnostic antigen manufacturing operations and historically, substantially all of our revenues have been derived from this business, our ability to substantially increase our revenues and generate net income is contingent on successfully developing one or more of our pipeline products. Our ability to develop any of the pipeline products is dependent on a number of factors, including funding availability to complete development efforts, our ability to adequately test and refine products, our ability to seek required FDA clearance or approval and our ability to commercialize our products, thereby generating revenues once development efforts prove successful. We have

11


TABLE OF CONTENTS

encountered in the past, and may again encounter in the future, problems in the testing phase for different pipelineour products, which sometimes resultedcan result in substantial setbacks and delays in the development process. There can be no assurance that we will not encounter similar setbacks with the products in our pipeline, or that funding from outside sources and our revenues will be sufficient to bring any or all of our pipeline products to the point of commercialization. There can be no assurance that the products we are developing will work effectively in the marketplace, or that we will be able to produce them on an economical basis.


TABLE OF CONTENTS

Our successFailure to obtain medical reimbursement for our products under development, as well as a changing regulatory and reimbursement environment, may impact our business.

The U.S. healthcare regulatory environment may change in a way that restricts our ability to market our acute appendicitis tests due to medical coverage or reimbursement limits. Sales of our human diagnostic tests will depend in part on establishingthe extent to which the costs of such tests are covered by health maintenance, managed care, and maintaining effective strategic partnershipssimilar healthcare management organizations, or reimbursed by government health payor administration authorities, private health coverage insurers and business relationships with third parties.

A key aspectother third-party payors. These healthcare payors are increasingly challenging the prices charged for medical products and services. The containment of healthcare costs has become a priority of federal and state governments. Accordingly, our business strategy is to establish and maintain strategic partnerships. We currently have a license arrangement with Washington University in St. Louis (WU). It is likely that we will seek other strategic alliances. We also intend to rely heavily on companies with greater capital resources and marketing expertise to market some of our products. We have identified certain possible candidates for other potential products. We may not reach definitive agreements with any potential strategic partners. Even if we enter into these arrangements, weproducts may not be ableconsidered to maintainbe cost effective, and reimbursement may not be available or sufficient to allow us to sell our products on a competitive basis. Because there is no reimbursement code for theAPPY1 test at this point, our reimbursement may be adversely affected. Legislation and regulations affecting reimbursement for our products may change at any time and in ways that are difficult to predict and these collaborationschanges may be adverse to us. Any reduction in Medicare, Medicaid or establish new collaborationsprivate third-party payor reimbursements could have a negative effect on our operating results. The recent addition of the medical device tax is also a challenge to the industry.

Health care legislation, including the Patient Protection and Affordable Care Act and the Health Insurance Portability and Accountability Act of 1996, may have a material adverse effect on us.

The Patient Protection and Affordable Care Act (PPACA) substantially changes the way healthcare is financed by government and private insurers, encourages improvements in healthcare quality, and impacts the medical device industry. The PPACA includes an excise tax on entities that manufacture or import medical devices offered for sale in the futureUnited States; a new Patient-Centered Outcomes Research Institute to conduct comparative effectiveness research; and payment system reforms.

The PPACA also imposes new reporting and disclosure requirements on acceptable terms. Furthermore, future arrangements maydevice and drug manufacturers for any payment or transfer of value made or distributed to physicians or teaching hospitals. Under these provisions, known as the Physician Payment Sunshine Act, affected device and drug manufacturers need to begin data collection on August 1, 2013, with the first reports due in 2014. These provisions require, among other things, extensive tracking and maintenance of databases regarding the disclosure of relationships and payments to physicians and teaching hospitals. In addition, certain states have passed or are considering legislation restricting our interactions with health care providers and/or requiring disclosure of many payments to them. Failure to comply with these tracking and reporting laws could subject us to grant certain rightssignificant civil monetary penalties.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) created new federal statutes to third parties,prevent healthcare fraud and false statements relating to healthcare matters. The healthcare fraud statute prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program, including exclusive marketing rights to one or more products, or may have other terms that are burdensome to us,private payors. A violation of this statute is a felony and may involveresult in fines, imprisonment or exclusion from government sponsored programs such as the issuanceMedicare and Medicaid programs. The false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of our securities. Our partnersor payment for healthcare benefits, items or services. A violation of this statute is a felony and may decideresult in fines or imprisonment or exclusion from government sponsored programs. HIPAA also established uniform standards governing the conduct of certain electronic healthcare transactions and protecting the security and privacy of individually identifiable health information maintained or transmitted by healthcare providers, health plans and healthcare clearinghouses.

Both federal and state government agencies are continuing heightened and coordinated civil and criminal enforcement efforts. As part of announced enforcement agency work plans, the federal government will continue to develop alternative technologies either on their own or in collaboration with others. If anyscrutinize, among other things, the billing practices of our partners terminate their relationship with us or failhospitals and other providers of healthcare services. The federal government also has increased funding to perform their obligations in a timely manner, or if we failfight healthcare fraud, and it is coordinating its enforcement efforts among various agencies, such as the U.S. Department of Justice, the Office of Inspector General and state Medicaid fraud control units. We believe that the healthcare industry will continue to perform our obligations in a timely manner, the development or commercialization of our technology in potential products may be affected, delayed or terminated.subject to increased government scrutiny and investigations.


TABLE OF CONTENTS

If we fail to obtain regulatory approval in foreign jurisdictions, then we cannot market our products in those jurisdictions.

We plan to market some of our products in foreign jurisdictions. Specifically, we expect that AppyScore will beto aggressively marketedmarketAPPY1 in foreign jurisdictions. We may market our therapeutic animal health products in foreign jurisdictions, as well. We may need to obtain regulatory approval from the European Union or other foreign jurisdictions to do so, and obtaining such approval in one jurisdiction does not necessarily guarantee approval in another. We may be required to conduct additional testing or to provide additional information, resulting in additional expenses, to obtain necessary approvals. If we fail to obtain approval in such foreign jurisdictions, we would not be able to sell our products in such jurisdictions, thereby reducing the potential revenue from the sale of our products.

We may be unable to retain key employees or recruit additional qualified personnel.

Because of the specialized scientific nature of our business, we are highly dependent upon qualified scientific, technical and managerial personnel. There is intense competition for qualified personnel in our business. A loss of the services of our qualified personnel, as well as the failure to recruit additional key scientific, technical and managerial personnel in a timely manner, would harm our development programs and our business.

Our product liability insurance coverage may not be sufficient to cover claims.

Our insurance policies currently cover claims and liabilities arising out of defective products for losses up to $2.0$3.0 million. As a result, if a claim was to be successfully brought against us, we may not have sufficient insurance that would apply and would have to pay any costs directly, which we may not have the resources to do.

12


TABLE OF CONTENTS

Risks Relating to our Intellectual Property

Our competitive position is contingent upon the productionstrength of our intellectual property, and we may not be able to withstand challenges to our intellectual property rights.

We rely on our intellectual property, including our issued and applied for patents and our licenses, as the foundation of our business. If our intellectual property rights are challenged, no assurances can be given that our patents or licenses will survive claims alleging invalidity or infringement on other patents and/or licenses.patents. Additionally, disputes may arise regarding inventorship of our intellectual property. There also could be existing patents of which we are unaware that our products may be infringing upon.infringing. As the number of participants in the market grows, the possibility of patent infringement claims against us increases. It is difficult, if not impossible, to determine how such disputes would be resolved. Furthermore, because of the substantial amount of discovery required in connection with patent litigation, there is a risk that some of our confidential information could be required to be publicly disclosed. In addition, during the course of patent litigation, there could be public announcements of the results of hearings, motions or other interim proceedings or developments in the litigation. Any litigation claims against us may cause us to incur substantial costs and could place a significant strain upon our financial resources, divert the attention of management or restrict our core business or result in the public disclosure of confidential information.business. The occurrence of any of the foregoing could materially impact our business.

We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights and we may be unable to protect our rights to, or use of, our technology.

Some or all of our patent applications may not issue as patents, or the claims of any issued patents may not afford meaningful protection for our technologies or products. In addition, patents issued to us or our licensors, if any, may be challenged and subsequently narrowed, invalidated, found unenforceable or circumvented. Patent litigation is widespread in the biotechnology industry and could harm our business. Litigation might be necessary to protect our patent positionposition. Patentability, invalidity, freedom-to-operate or other opinions may be required to determine the scope and validity of third-party proprietary rights.

If we choose to go to court to stop someone elsea third party from using the inventions claimed inprotected by our patents,patent, that individual or companythird party would have the right to ask the court to rule that such patents are invalid and/or should not be enforced against that third party. These lawsuits are expensive and we may not have the required resources to pursue


TABLE OF CONTENTS

such litigation or to protect our patent rights. In addition, there is a risk that the court will decide that theseour patents are not valid and that we do not have the right tocannot stop the other party from using thetheir inventions. There is also the risk that, even if the validity of these patents is upheld, the court will refuse to stopfind that the other party on the ground that such otherthird party’s activities do not infringe our rights in these patents.

Furthermore, a third party may claim that we are using inventions covered byinfringing the third party’s patent rights and may go to court to stop us from engaging in our normal operations and activities, including making or selling our product candidates. These lawsuits are costly and could affect our results of operations and divert the attention of managerial and technical personnel. There is a risk that a court would decide that we are infringing the third party’s patents and would order us to stop the activities covered by the patents. In addition, there is a risk that a court will order us to pay the other partyparty’s treble damages or attorneys’ fees for having violated the other party’s patents. The biotechnology industry has produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform. If we are sued for patent infringement, we would need to demonstrate that our products or methods of use either do not infringe the claims of the relevant patent and/or that the third party patent claims are invalid, and we may not be able to do this. Proving invalidity in the United Sates, in particular, is difficult since it requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents.

In addition, changes in either patent laws or in interpretations of patent laws in the United States and other countries may materially diminish the value of our intellectual property or narrow the scope of our patent protection. In September 2011, the U.S. Congress passed the Leahy-Smith America Invents Act (AIA) which became effective in March 2013. The AIA reforms United States patent law in part by changing the standard for patent approval for certain patents from a “first to invent” standard to a “first to file” standard and developing a post-grant review system. It is too early to determine what the effect or impact the AIA will have on the operation of our business and the protection and enforcement of our intellectual property. However, the AIA and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business and financial condition.

Because some patent applications in the United States may be maintained in secrecy until the patents are issued, patent applications in the United States and many foreign jurisdictions are typically not published until eighteen months after filing, and publications in the scientific literature often lag behind actual discoveries, wediscoveries. We cannot be certain that others have not filed patent applications for technology covered by our issued patents or our pending applications or that we were the first to invent the technology.technology (pre-AIA) or first to file (post-AIA). Our competitors may have filed, and may in the future file, patent applications covering technology similar toor the same as ours. Any such patent application may have priority over our patent applicationsapplication and could further require us to obtain rights to issued patents

13


TABLE OF CONTENTS

covering such technologies.technologies in order to carry on our business. If another party has filed a U.S. patent application on inventions similar toor the same as ours, we may have to participate in an interference or other proceeding in the U.S. Patent and Trademark Office, or the PTO,USPTO, or a court to determine priority of invention in the United States.States, for pre-AIA applications and patents. The costs of these proceedings could be substantial, and it is possible that such efforts would be unsuccessful, resulting in a loss of our U.S. patent position with respect to such inventions.

Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations.

Obtaining and maintaining our patent protection depends upon compliance with various procedural, document submission,submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

The PTOUSPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process.prosecution process and post issuance of a patent. There are situations in which noncompliance of these requirements can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in


TABLE OF CONTENTS

the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been the case.case if our patent were enforce.

Our failure to secure trademark registrationregistrations could adversely affect our ability to market our product candidates and our business.

Our trademark applications in the United States when filed, and any other jurisdictions where we may file may not be allowed for registration, and our registered trademarks may not be maintained or enforced. During trademark registration proceedings, we may receive rejections. Although we are given an opportunity to respond to those rejections, we may be unable to overcome such rejections. In addition, in the PTOUSPTO and in comparablecorresponding foreign agencies, in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our applications and/or registrations, and our applications and/or registrations may not survive such proceedings. Failure to secure such trademark registrations in the United States and in foreign jurisdictions could adversely affect our ability to market our product candidates and our business.

Confidentiality agreements with employees and others may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protect our intellectual property, which could impede our ability to compete.

Because we operate in the highly technical field of biotechnology and pharmaceutical development, we rely in part on trade secret protection in order to protect our proprietary trade secrets and unpatented know-how. However, trade secrets are difficult to protect, and we cannot be certain that others will not develop the same or similar technologies on their own. We have taken steps, including entering into confidentiality agreements with all of our employees, consultants and corporate partners, to protect our trade secrets and unpatented know-how. These agreements generally require that the other party to the agreement keep confidential and not disclose to third parties all confidential information developed by the party or made known to the party by us during the course of the party’s relationship with us. We also typically obtain agreements from these parties which provide that inventions conceived or developed by the party in the course of rendering services to us will be our exclusive intellectual property. However, these agreements may not be honored and may not effectively assign intellectual property rights to us. Enforcing a claim that a party illegally obtained and is using our trade secrets or know-how is difficult, expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States may be less willing to protect trade secrets or know-how. The failure to obtain or maintain trade secret protection could adversely affect our competitive position.

14


��

TABLE OF CONTENTS

We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

As is common in the biotechnology and pharmaceutical industry, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although the Company has no knowledge of any claims against us, are currently pending, we may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

We may not be able to adequately protect our intellectual property outside of the United States.

The laws in some of those countriesforeign jurisdictions may not provide protection for our trade secrets and other intellectual property. If our trade secrets or other intellectual property are misappropriated in those countries,foreign jurisdictions, we may be without adequate remedies to address the issue.these issues. Additionally, we also rely on confidentiality and assignment of invention agreements to protect our intellectual property. These agreements may provide for contractual remedies in the event of misappropriation. We do not know to what extent, if any, these agreements and any remedies for their breach, will be enforced by a foreign or domestic court. In the event our intellectual property is misappropriated or infringed upon and an adequate remedy is not available, our future prospects will greatlylikely diminish.


TABLE OF CONTENTS

Additionally, prosecuting and maintaining intellectual property (particularly patent) rights are very costly endeavors. We do not know whether legal and government fees will increase substantially and therefore are unable to predict whether cost may factor into our intellectual property strategy.

Risks Related to Our Securities

While our common stock currently trades on the NASDAQ Capital Markets Exchange, our share price is below NASDAQ’s $1.00 minimum bid price rule, which could subject our shares to de-listing.

On February 13, 2012, the Company was notified by NASDAQ that the Company did not meet the minimum bid price rule required for continued listing and was provided until August 13, 2012 to achieve compliance with such minimum bid rule. If at any time before August 13, 2012, the bid price of our common stock closes at $1.00 per share or more for a minimum of 10 consecutive trading days (subject to extension to 20 trading days in NASDAQ’s discretion), we will regain compliance with the bid price rule. Our shareholders have approved a reverse stock split transaction to help achieve such compliance. If we do not regain compliance by the end of this grace period, we anticipate we will receive notification from NASDAQ that our common stock is subject to delisting. At that time we may then appeal the delisting determination to a Hearings Panel. Such notification will have no immediate effect on our listing on the NASDAQ Capital Market nor will it have an immediate effect on the trading of our common stock pending such hearing. There can be no assurance, however, that we will be able to regain compliance with NASDAQ’s minimum bid price per share requirement for continued listing on the NASDAQ Capital Market. Being delisted by NASDAQ could have a negative impact on our ability to raise capital among other considerations.

While our common stock currently trades on the NASDAQ Capital Markets Exchange, our total stockholders’ equity is below NASDAQ’s $2.5 million requirement, which could subject our shares to de-listing.

The Company did not meet NASDAQ’s minimum stockholders’ equity required for continued listing as of March 31, 2012. On May 15, 2012, the Company received a letter from NASDAQ regarding the failure to meet that requirement and under NASDAQ rules the Company has forty-five days to submit a plan to regain compliance with such rule. If such plan is accepted, the Company could be granted an extension of up to 180 calendar days to regain compliance with the rule. The letter has no immediate effect on our listing on the NASDAQ Capital Market nor on the trading of our common stock. There can be no assurance, however, that we will be able to regain compliance with NASDAQ’s minimum shareholders’ equity requirement for continued listing on the NASDAQ Capital Market. Being delisted by NASDAQ could have a negative impact on our ability to raise capital among other considerations.

15


TABLE OF CONTENTS

We require additional capital for future operations and we cannot assure you that capital will be available on reasonable terms, if at all, or on terms that would not cause substantial dilution to our existing shareholders.

We have historically needed to raise capital to fund our operating losses including development expenses, which have been significant. We expect to continue to incur operating losses in the 2012 calendar year and at least into 2013. If capital requirements vary materially from those currently planned, we may require additional capital sooner than expected. There can be no assurance that such capital will be available in sufficient amounts or on terms acceptable to us, if at all, especially in light of the state of the current financial markets which could impact the timing, terms and other factors in our attempts to raise capital. Any sale of a substantial number of additional shares may cause dilution to our existing shareholders and could also cause the market price of our common stock to decline.

Current challenges in the commercial and credit environment may adversely affect our business and financial condition.

The global financial markets have recently experienced unprecedented levels of volatility. Our ability to generate cash flows from operations, issue debt or enter into other financing arrangements on acceptable terms could be adversely affected if there is a material decline in the demand for the Company’sour products or in the solvency of its customers or suppliers, deterioration in the Company’sour key financial ratios or credit ratings, or other significantly unfavorable changes in conditions. While these conditions and the current economic downturn have not meaningfully adversely affected our operations to date, continuing volatility in the global financial markets could increase borrowing costs or affect the company’sour ability to access the capital markets. Current or worsening economic conditions may also adversely affect the business of our customers, including their ability to pay for our products and services, and the amount spent on healthcare in general. This could result in a decrease in the demand for our potential products and services, longer sales cycles, slower adoption of new technologies and increased price competition. These conditions may also adversely affect certain of our suppliers, which could cause a disruption in our ability to produce our products.

We do not anticipate paying any dividends in the foreseeable future and, as a result, our investors’ sole source of gain, if any, will depend on capital appreciation, if any.

The Company doesWe do not intend to declare any dividends on our shares of common stock in the foreseeable future and currently intends to retain any future earnings for funding growth. As a result, investors should not rely on an investment in our securities if they require the investment to produce dividend income. Capital appreciation, if any, of our shares may be investors’ sole source of gain for the foreseeable future. Moreover, investors may not be able to resell their shares of our common stock at or above the price they paid for them.

As a public company we are subject to complex legal and accounting requirements that require us to incur substantial expenses, and our financial controls and procedures may not be sufficient to ensure timely and reliable reporting of financial information, which, as a public company, could materially harm our stock price and listing on the NASDAQ Capital Market.

As a public company, we are subject to numerous legal and accounting requirements that do not apply to private companies. The cost of compliance with many of these requirements is substantial, not only in absolute terms but, more importantly, in relation to the overall scope of the operations of a small company. Failure to comply with these requirements can have numerous adverse consequences including, but not limited to, our inability to file required periodic reports on a timely basis, loss of market confidence, delisting of our securities and/or governmental or private actions against us. We cannot assure you that we will be able to comply with all of these requirements or that the cost of such compliance will not prove to be a substantial competitive disadvantage vis-à-vis our privately held and larger public competitors.

The Sarbanes-Oxley Act of 2002 (Sarbanes-Oxley) requires, among other things, that we maintain effective internal controls over financial reporting and disclosure controls and procedures. In particular, we must perform system and process evaluation and testing of our internal control over financial reporting to allow management to report on the effectiveness of our internal control over financial reporting, as required by Section 404 of Sarbanes-Oxley. Our compliance with Section 404 of Sarbanes-Oxley requires that we incur substantial accounting expense and expend significant management efforts. The effectiveness of our controls and procedures may in the future be limited by a variety of factors, including:

faulty human judgment and simple errors, omissions or mistakes;
fraudulent action of an individual or collusion of two or more people;

TABLE OF CONTENTS

inappropriate management override of procedures; and
the possibility that any enhancements to controls and procedures may still not be adequate to assure timely and accurate financial information.

If we are not able to comply with the requirements of Section 404 in a timely manner, or if we or our independent registered public accounting firm identifies deficiencies in our internal control over financial reporting that are deemed to be material weaknesses, we may be subject to NASDAQ delisting, investigations by the SEC and civil or criminal sanctions.

Our ability to successfully implement our business plan and comply with Section 404 requires us to be able to prepare timely and accurate financial statements. We expect that we will need to continue to improve existing, and implement new operational, financial and accounting systems, procedures and controls to manage our business effectively.

Any delay in the implementation of, or disruption in the transition to, new or enhanced systems, procedures or controls may cause our operations to suffer, and we may be unable to conclude that our internal control over financial reporting is effective as required under Section 404 of Sarbanes-Oxley. If we are unable to complete the required Section 404 assessment as to the adequacy of our internal control over financial reporting, if we fail to maintain or implement adequate controls, our ability to obtain additional financing could be impaired. In addition, investors could lose confidence in the reliability of our internal control over financial reporting and in the accuracy of our periodic reports filed under the Securities Exchange Act of 1934, as amended (Exchange Act). A lack of investor confidence in the reliability and accuracy of our public reporting could cause our stock price to decline.

Our stock price, like that of many biotechnology companies, is volatile.

The market prices for our common stock and for the securities of biotechnology companies in general have been highly volatile and may continue to be highly volatile in the future, particularly in light of the current financial markets. For example, in the year ended December 31, 2012, our common stock traded as low as $1.33 and as high as $5.88. In addition, the year ended December 31, 2011, our common stock traded as low as $5.82 and as high as $25.50 (each on a post reverse stock splits basis). The market price of our common stock has been and may continue to be volatile, especially on the eve of Company announcements which the market is expecting, as is the case with clinical trial results. Among other factors, the following may have a significant effect on the market price of our common stock:

announcements of clinical trial results, FDA correspondence or interactions, developments with regard to our intellectual property rights, technological innovations or new commercial products by us or our competitors;
publicity regarding actual or potential medical results related to products under development or being commercialized by us or our competitors;
regulatory developments or delays affecting our products under development in the United States and other countries; and
new proposals to change or reform the U.S. healthcare system, including, but not limited to, new regulations concerning reimbursement programs.

16


TABLE OF CONTENTS

Risks Related to This Offering

Management willThese fluctuations may have broad discretion as to the use of the net proceeds from this offering, and we may not use the proceeds effectively.

Our management will have broad discretion as to the application of the net proceeds and could use them for purposes other than those contemplated at the time of this offering. Our shareholders may not agree with the manner in which our management chooses to allocate and spend the net proceeds. Moreover, our management may use the net proceeds for corporate purposes that may not increase our profitability or our market value.

A substantial number of shares of common stock may be sold in the market following this offering, which may depress the market price for our common stock.

Sales of a substantial number of shares of our common stock in the public market following this offering could causenegative effect on the market price of our common stock to decline. A substantial majority of the outstanding sharesregardless of our common stock are,operating performance. In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been instituted. A securities class action suit against us could result in substantial costs, potential liabilities and the sharesdiversion of common stock sold in this offering upon issuance will be, freely tradable without restriction or further registration under the Securities Act. In addition, as of May 24, 2012, 535,370 shares ofmanagement’s attention and resources, and could have a material adverse effect on our common stock, as if a 1-for-6 reverse stock split had been effected, are issuable upon exercise of outstanding options and warrants (not including shares issuable upon exercise of the warrants to be issued in this offering).financial condition.

Investors in this offering will pay a much higher price than the book value of our stock.

If you purchase common stock in this offering, you will incur an immediate and substantial dilution in net tangible book value of $1.32 per share, after giving effect to the sale by us of common shares in this offering at the assumed offering price of $3.84 per common share, all assuming a 1-for-6 reverse stock split had been effected.

Risks Related to Our Proposed Reverse Stock Split

Our shareholders have approved a reverse split of our common stock for the purpose of meeting the minimum bid requirement imposed by the NASDAQ Stock Market for continued listing. However, the reverse stock split, ultimately, may not increase our stock price and weWe may not be able to continue to listmaintain our common stockcurrent listing on the NASDAQ Capital Market.Market and a delisting could limit the liquidity of our stock, increase its volatility and hinder our ability to raise capital.

We expectOn February 13, 2012, we received notice from NASDAQ that our stock trading price was not in compliance with NASDAQ’s requirement that listed companies maintain a price of at least $1.00 per share. Further, on May 15, 2012, we received notice from NASDAQ of our non-compliance with the listing requirement to


TABLE OF CONTENTS

maintain stockholders’ equity of at least $2,500,000. Following the completion of a public offering in June 2012, and a one-for-six reverse stock split of our common stock will increase the market price of our common stock so thateffected on June 20, 2012, we are able to regainregained compliance with both standards for continued listing on the minimum bid price requirement of the Listing Rules of The NASDAQ StockCapital Market. However, the effect of a reverse stock split upon the market price of our common stock cannotThere can be predicted with certainty, and the results of reverse stock splits by companies in similar circumstances are varied. It is possible that the share price of our common stock immediately after the reverse stock split will not remain increased in proportion to the reduction in the number of shares of our common stock outstanding.

Even if the reverse stock split achieves the requisite increase in our stock price, we cannot assure youno assurance that we will be able to comply or continue to comply withmaintain the minimum bid price requirement.

There can be no assurance that the market price of our post-reverse split shares will increase sufficiently for us to be in compliance with the minimum bid price requirement, or that the price will remain at the level required for continuing compliance with that requirement. It is not uncommon for a company’s share price to decline in the period following the reverse split. If we effect a reverse stock split and the market pricelisting of our common stock declines, the percentage decline may be greater than would occur in the absence of a reverse stock split. In any event, other factors unrelated to the number of shares offuture.

If our common stock outstanding, such as our future operating results, will influence the market price of our stock. Negative financial or operational results or adverse market conditions could affect the market price of our common stock and jeopardize our ability to meet or maintain NASDAQ’s continued listing requirements. In addition to specific listing and maintenance standards,is delisted by NASDAQ, has broad discretionary authority over the initial and continued listing of securities, which it could exercise with respect to our common stock.

17


TABLE OF CONTENTS

The reverse stock split may decrease the liquidity of our stock.

The liquidity of our common stock may be affected adversely byeligible for quotation on an over-the-counter quotation system or on the reverse split givenpink sheets. Upon any such delisting, our common stock would become subject to the reduced number of shares that will be outstanding after the reverse split, especially if our stock price does not increase as a resultregulations of the reverseSecurities and Exchange Commission, or SEC, relating to the market for penny stocks. A penny stock split. In addition,is any equity security not traded on a national securities exchange that has a market price of less than $5.00 per share. The regulations applicable to penny stocks may severely affect the proposed reversemarket liquidity for our common stock split may increaseand could limit the numberability of shareholders who own odd lots (less than 100 shares)to sell securities in the secondary market. In such a case, an investor may find it more difficult to dispose of or obtain accurate quotations as to the market value of our common stock, creating the potential for such shareholders to experience an increase in the cost of selling their shares and greater difficulty effecting sales.

After the reverse stock split, the resulting stock price may not attract new investors, including institutional investors, and may not satisfy the investing requirements of those investors. Consequently, the trading liquidity of our common stock may not improve.

Although we believe that a higher stock price may help generate greater or broader investor interest, there can be no assurance that our common stock will be eligible for trading or quotation on any alternative exchanges or markets.

Delisting from NASDAQ could adversely affect our ability to raise additional financing through public or private sales of equity securities, would significantly affect the reverse stock split will result in a share price that will attract newability of investors including institutional investors. In addition, there can be no assurance thatto trade our securities and would negatively affect the share price will satisfy the investing requirements of those investors. As a result, the tradingvalue and liquidity of our common stock may not necessarily improve.stock. Delisting could also have other negative results, including the potential loss of confidence by employees, the loss of institutional investor interest and fewer business development opportunities.


18


 

TABLE OF CONTENTS

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

Some of the statements contained in thisThis prospectus arecontains forward-looking statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange ActAct. All statements, other than statements of 1934, as amended (the “Exchange Act”),historical fact, included or incorporated in this report regarding our strategy, future operations, collaborations, intellectual property, cash resources, financial position, future revenues, projected costs, prospects, plans, and objectives of management are subject to the safe harbor created by the Securities Litigation Reform Act of 1995.forward-looking statements. The words “believe,“believes,” “anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,” “could,” “should,” “predict,“potential,“future,“likely,“may,“projects,“might,“continue,” “will,” “would,” “estimate,” “continue,” “could,” “anticipate,” “intend,” “plan,” “expect,” “potential,” “continue,” or “opportunity,” or the negative thereof, or other words and terms of“would” and similar meaning, as they relate to us, our business, prospects, future financial or operating performance or our management,expressions are intended to identify forward-looking statements. Whilestatements, although not all forward-looking statements made by us are basedcontain these identifying words. We cannot guarantee that we actually will achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our current intent, belief, judgment, assumptions, estimates and projections andforward-looking statements. There are believed by us to be reasonable, they are subject to risks and uncertainties, manya number of which are beyond our control. These risks and uncertaintiesimportant factors that could cause our actual results performance or achievements to varydiffer materially from those indicated or implied by forward-looking statements. These important factors include those set forth above under the forward-looking statements, including the following risks and uncertainties:

our ability to continue as a going concern and to raise additional capital, as necessary, on acceptable terms or at all;
having available funding for the continued development of AppyScore;
the success of the clinical trials to support clearance or approval for AppyScore;
changes in regulationsheading “Risk Factors.” These factors and the adoption of new regulations;
delays in initiating, conducting or completing clinical trials and the satisfactory results of our clinical trials;
uncertainty related to our ability to obtain clearance or approval of our products by the FDA and regulatory bodies in other jurisdictions;
uncertainty relating to certain of our patents, future patent and other intellectual property infringement claims by third parties and our inability to protect our intellectual property;
market acceptance of our products and the estimated potential size of these markets;
pricing and reimbursement for approved or cleared products;
dependence on third parties for clinical development and manufacturing;
dependence on a limited number of key employees;
competition and risk of competitive new products and alternative technologies;
the proposed reverse stock split;
volatility in the value of our common stock;
volatility in the financial markets generally; and
the other risks and uncertainties described under “Risk Factors” or elsewhere in this prospectus.

You should consider the risks above carefully in addition to other information containedcautionary statements made in this prospectus before purchasingshould be read as being applicable to all related forward-looking statements whenever they appear in this prospectus. In addition, any forward-looking statements represent our common stock. If any of these risks occur, they could seriously harm our business, prospects, financial condition and results of operations. In such case, the trading price of our common stock could decline, and you may lose all or part of your investment.

Any forward-looking statement speaksestimates only as of the date on which itthat this prospectus is made,filed with the SEC, and we undertake noshould not be relied upon as representing our estimates as of any subsequent date. We do not assume any obligation to update any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statement, to reflectwhether as a result of new information, future events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. New factors will emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Past financial or operating performance is not necessarily a reliable indicator of future performance and you should not use our historical performance to anticipate results or future period trends.

Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements.otherwise.


19


 

TABLE OF CONTENTS

USE OF PROCEEDS

We expect to receive approximately $13.4 million inestimate that the net proceeds fromto us of the sale of the shares of common stock offered by us in thisthat we are offering will be approximately $11.1 million, based on thean assumed public offering price of $3.84$1.68 per share, or approximately $15.4 million ifwhich price was the underwriters exercise their over-allotment in full. “Net proceeds” is what we expect to receivelast reported sale price of our common stock reported on the Nasdaq Capital Market on May 16, 2013, after payingdeducting the expenses of this offering, including theestimated underwriting discounts and commissions as described in “Underwriting” and other estimated offering expenses payable by us, which include legal, accounting and printing fees.us. If the underwriter exercises its over-allotment option in full, we estimate that our net proceeds will be approximately $12.9 million.

We intend to use the net proceeds to us from this offering, together with our existing cash resources, for working capital and other general corporate purposes, including conducting ourfunding for further clinical trialdevelopment, seeking FDA clearance for AppyScore. We have not yet determined with certaintyAPPY1, and for initial commercialization ofAPPY1 in the manner in which we will allocateU.S. and the net proceeds; however, we currently anticipate using:E.U.

approximately $2.8 million to complete activities required for regulatory Pre-IDE submission to the FDA and undertake a clinical trial for AppyScore;
approximately $5.0 million to operating and development expenses to be incurred during the upcoming quarters; and
approximately $5.6 million to general corporate purposes, intellectual property and working capital.

The amounts described above are only an estimate of the expenses we currently anticipate will be necessary to undertake the clinical trial. We may also invest working capital in acquiring or developing technologies or products that complement our business. Our management will have broad discretion in the application of the net proceeds, and investors will be relying on the judgment of our management regarding the application of the net proceeds of this offering.

Until wePending use of the net proceeds of this offering,as described above, we intend to invest the fundsproceeds in short-term, interest-bearing, investment grade interest-bearing securities.

20


TABLE OF CONTENTS

DIVIDEND POLICY

We have never declared or paid cash dividends on our capital stock. We currently intend to retain our future earnings, if any, for use in our business and therefore do not anticipate paying cash dividends in the foreseeable future. Payment of future dividends, if any, will be at the discretion of our board of directors after taking into account various factors, including our financial condition, operating results and current and anticipated cash needs. Our building mortgage loan restricts us from paying dividends without the lender’s consent.


21


 

TABLE OF CONTENTS

CAPITALIZATION

The following table presents a summary of our cash, cash equivalents, short-term investments and capitalization as of March 31, 2012:2013:

on an actual basis, which consists of the shares of common stock outstanding on March 31, 2012;basis; and
on an as adjusted basis to reflect our receipt of estimated net proceeds of approximately $13.4$11.1 million from the sale of shares of common stock in this offering at an assumed public offering price of $3.84$1.68 per share, the closing price of the Company’s common stock on May 24, 2012, as adjusted to reflect the 1-for-6 reverse stock split and16, 2013, after deducting the estimated underwriting discounts and commissions and estimated offering expenses.

This table gives effect to the anticipated 1-for-6 reverse stock split that we intend to effect immediately prior to the date of this prospectus.

You should read the following table in conjunction with “Use of Proceeds,” “Summary“Selected Financial Information,” “Management’s Discussion and Analysis of Financial Condition and Results of Operation”Operations” and the historical consolidated financial statements and the related notes thereto included in this prospectus.

  
 As of March 31, 2012  
 (in thousands except share and
per share amounts)
 As of March 31, 2013
 Actual As Adjusted Actual As Adjusted
Cash, cash equivalents and short-term investments $1,878,000  $15,228,000  $9,268,000  $20,398,000 
Current liabilities $1,654,000  $1,654,000  $3,220,000  $3,220,000 
Long-term liabilities $2,603,000  $2,603,000  $2,001,000  $2,001,000 
Shareholders’ equity
          
Common stock ((i) Actual: 30,000,000 shares authorized, no par value; 1,605,554 shares issued and outstanding and (ii) As Adjusted: 30,000,000 shares authorized, no par value; 5,511,804 shares issued and outstanding) $69,069,000  $82,419,000 
Accumulated Deficit $(66,959,000 $(66,959,000
Stockholders’ equity
          
Common stock ((i) Actual: 30,000,000 shares authorized, no par value; 9,954,380 shares issued and outstanding and (ii) As Adjusted: 30,000,000 shares authorized, no par value; shares issued and outstanding) $85,408,000  $96,538,000 
Accumulated deficit $(77,035,000 $(77,035,000

The number of shares intable excludes the table above excludesfollowing as of March 31, 2012 (and giving effect to the anticipated 1-for-6 reverse stock split):2013:

195,2941,175,566 shares of common stock issuable upon the exercise of outstanding options granted under our stock option plans at a weighted average exercise price of $56.61$9.25 per share;
46,005598,006 shares of common stock issuable upon exercise of options granted outside of our stock option plans and warrants at a weighted average exercise price of $4.97 per share;
311,639 shares of common stock available for future issuance under our stock option plans; and
281,667 shares of common stock issuable upon exercise of our non-qualified options and warrants, 267,500 of which are exercisable for $7.32 per share and 14,167 of which are exercisable for $29.92 per share;
4,167 shares of restricted stock issued on April 2, 2012 to a consultant of the Company;
585,937     shares of common stock issuable upon exercise of the underwriters’underwriter’s over-allotment option; andoption.
195,312 shares

On April 17, 2013, our board of common stock underlyingdirectors approved an amendment to our Articles of Incorporation, as amended, to increase the warrants to be issued to the representative of the underwriters in connection with this offering.

22


TABLE OF CONTENTS

DILUTION

Our net tangible book value as of March 31, 2012 was approximately $0.5 million, or approximately $0.34 per share of common stock, after giving effect to the 1-for-6 reverse stock split that we expect to effect immediately prior to the date of this prospectus. Net tangible book value per share represents total assets minus capitalized patent costs, other intangibles and total liabilities, divided by the number of shares of common stock outstanding. Dilutionwe are authorized to issue from 30,000,000 to 60,000,000, with such amendment being subject to shareholder approval. The amendment is being submitted to shareholders for approval at the annual meeting of shareholders on June 11, 2013.


TABLE OF CONTENTS

DILUTION

If you invest in net tangible book value per share representsour securities in this offering, your ownership interest will be immediately diluted to the extent of the difference between the amountassumed price per share paid by purchasers of our common stock in this offering and the as adjusted net tangible book value per share of our common stock immediately afterupon closing of this offering. Net tangible book value per share of our common stock is determined at any date by subtracting our total liabilities from the offering.

After giving effect toamount of our total tangible assets (total assets less intangible assets) and dividing the saledifference by the number of shares of our common stock deemed to be sold in this offeringoutstanding at an assumed offering price of $3.84 per share, the closing price of the Company’s common stock on May 24, 2012, as adjusted to reflect the anticipated reverse stock split and after deduction of estimated underwriting discounts and commissions and offering expenses payable by us, our pro formathat date.

Our historical net tangible book value as of March 31, 2012 would have been2013 was approximately $13.9 million,$6,765,000, or $2.52 per share. The adjustments made to determine pro forma net tangible book value$0.68 per share are the following:

An increase in total assets to reflect the net proceeds of the offering as described under “Use of Proceeds”; and
The addition of the number ofour outstanding common stock, based on 9,954,380 shares of common stock offered underoutstanding as of March 31, 2013.

Investors participating in this prospectus to the number of shares outstanding.

The following table illustrates the pro forma increase in net tangible book value attributable to existing shareholders of $2.18 per share, afteroffering will incur immediate and significant dilution. After giving effect to the 1-for-6 reverse stock split we expect to effect immediately prior to the dateissuance and sale in this offering of this prospectus and the dilution (the difference between the offering price per share and net tangible book value per share) to new investors:

  
Offering price per share      $3.84 
Net Tangible book value per share as of March 31, 2012 $0.34      
Increase in net tangible book value per share attributable to this offering $2.18    
Pro forma net tangible book value per share as of March 31, 2012, after giving effect to this offering    $2.52 
Dilution per share to new investors of this offering    $(1.32

If the underwriters exercise in full their over-allotment option to purchase 585,937 shares of our common stock offered in this offering, at thean assumed public offering price of $3.84$1.68 per share of our common stock, which price was the last reported sale price of our common stock on the Nasdaq Capital Market on May 16, 2013, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, our as adjusted net tangible book value after this offeringas of March 31, 2013 would be $2.62have been approximately $17.9 million, or approximately $1.03 per share representingof our common stock. This amount represents an immediate increase in net tangible book value of $2.28$0.35 per share of our common stock to existing shareholders and an immediate dilution in net tangible book value of $1.22$(0.65) per share of our common stock to new investors purchasing shares in this offering. The following table illustrates this dilution:

 
Assumed public offering price per share of common stock $1.68 
Historical net tangible book value per share of our common stock as March 31, 2013 $0.68 
As adjusted increase in net tangible book value per share of our common stock attributable to investors participating in this offering $0.35 
As adjusted net tangible book value per share of our common stock after this offering $1.03 
Dilution of as adjusted net tangible book value per share to new investors $(0.65

If the underwriter’s over-allotment option is exercised in full, the as adjusted net tangible book value per share of our common stock in this offering at the public offering price.

The number of shares in the table above reflects the anticipated 1-for-6 reverse stock split that we intend to effect immediately prior to the date of this prospectus but excludes as of March 31, 2012 (andafter giving effect to the anticipated 1-for-6 reverse stock split):

195,294 sharesthis offering would be $1.06 per share, which amount represents an immediate increase in net tangible book value of $0.03 per share of our common stock issuable upon the exerciseto existing shareholders and an immediate dilution in net tangible book value of outstanding options at a weighted average exercise price$0.03 per share of $56.61 per share;
46,005 shares ofour common stock available for future issuance under our stock option plans;
281,667to new investors purchasing shares of common stock issuable upon exercise of our non-qualified options and warrants, 267,500 of which are exercisable for $7.32 per share and 14,167 of which are exercisable for $29.92 per share;
4,167 shares of restricted stock issued on April 2, 2012 to a consultant of the Company; and
195,312 shares of common stock underlying the warrants to be issued to the representative of the underwriters in connection with this offering.

23



 

TABLE OF CONTENTS

MARKETCOMMON STOCK PRICE INFORMATIONRANGE

Our common stock is quoted on the NASDAQ Capital Market under the symbol “APPY”. The following table shows the high and low sale prices per share of our common stock as reported by the NASDAQ Stock Market during the periods presented. Prices per share of our common stock have beenwere adjusted to reflect the 1-for-5 reverse split of our common stock that was effected on July 28, 2011. These prices do not reflect the 1-for-6one-for-five reverse stock split that is anticipated to be effected in connection with this offering.effective July 28, 2011, and the one-for-six reverse stock split effective June 20, 2012.

    
 Price Range Price Range
 High Low High Low
2010
          
First Quarter $11.85  $9.55 
Second Quarter  23.20   4.75 
Third Quarter  5.60   2.45 
Fourth Quarter  3.55   1.60 
2011
                    
First Quarter $4.25  $2.80  $25.50  $16.80 
Second Quarter  3.94   3.10   23.61   18.60 
Third Quarter  3.75   2.40   22.50   14.40 
Fourth Quarter  2.92   0.97   17.53   5.82 
2012
                    
First Quarter $1.09  $0.58  $5.88  $3.90 
Second Quarter (through May 24, 2012)  0.74   0.55 
Second Quarter  4.44   1.88 
Third Quarter  2.77   1.33 
Fourth Quarter  2.93   2.04 
2013
          
First Quarter $2.80  $1.96 
Second Quarter (through May 16, 2013)  2.20   1.65 

On May 24, 2012,16, 2013, the last sale price of our common stock, as reported by the NASDAQ Capital Market, was $0.64$1.68 per share. On May 24, 2012,1, 2013, there were approximately 950 holders of record and approximately 5,9002,600 beneficial holders of our common stock.


24


 

TABLE OF CONTENTS

SELECTED FINANCIAL DATA

The following tables summarize our financial data for the periods presented. The selected statements of operations data for the years ended December 31, 2012, 2011 and 2010 and the balance sheet data as of December 31, 2012 and 2011 have been derived from our audited financial statements, which are included in this prospectus. The selected statements of operations data presented below for the years ended December 31, 2009 and 2008 and the selected balance sheet data as of December 31, 2010, 2009 and 2008 are derived from audited financial statements, which are not included in this prospectus. The selected financial historical data for the quarterly periods ended March 31, 2013 and 2012 are derived from interim unaudited financial statements, which are included in this prospectus. The historical results are not necessarily indicative of the results to be expected for any future periods. You should read this data together with the financial statements and related notes included elsewhere in this prospectus, as well as “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the other financial information included elsewhere in this prospectus.

       
 For the Fiscal Year Ended
December 31,
 For the Three Months Ended March 31,
   2012 2011 2010 2009 2008 2013 2012
Selected Statements of Operations Data:
                                   
Sales $42,000  $219,000  $370,000  $291,000  $821,000  $  $7,300 
Net loss $(9,212,000 $(10,214,000 $(13,338,000 $(15,518,000 $(9,658,000 $(2,802,000 $(1,938,000
Basic and diluted net loss per share $(1.84 $(7.61 $(10.17 $(14.03 $(9.21 $(0.28 $(1.21
Weighted average shares outstanding  4,996,827   1,341,379   1,310,956   1,105,639   1,105,639   9,954,380   1,608,146 

       
       
 As of December 31, As of March 31,
   2012 2011 2010 2009 2008 2013 2012
Selected Balance Sheet Data:
                                   
Current assets $12,528,000  $4,321,000  $12,307,000  $14,427,000  $18,871,000  $9,554,000  $2,091,000 
Total assets $16,615,000  $8,728,000  $17,159,000  $19,378,000  $24,187,000  $13,594,000  $6,367,000 
Current Liabilities $4,079,000  $2,072,000  $2,731,000  $3,275,000  $2,746,000  $3,219,604  $1,654,000 
Long term liabilities $1,845,000  $2,830,000  $3,180,000  $3,290,000  $3,553,000  $2,001,495  $2,603,000 
Total liabilities $5,924,000  $4,902,000  $5,912,000  $6,564,000  $6,299,000  $5,221,000  $4,257,000 
Stockholders’ equity $10,691,000  $3,826,000  $11,247,000  $12,814,000  $17,888,000  $8,373,000  $2,110,000 

TABLE OF CONTENTS

MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

TheYou should read the following discussion and analysis below includes certain forward-lookingof our financial condition and results of operations together with our financial statements that are subject to risks, uncertaintiesand the related notes and other factors, as describedfinancial information included elsewhere in “Risk Factors”this prospectus. Some of the information contained in this discussion and analysis or set forth elsewhere in this prospectus, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. You should review the “Risk Factors” section of this prospectus for a discussion of important factors that could cause our actual growth, results of operations, performance, financial position and business prospects and opportunities for this fiscal year and the periods that follow to differ materially from those expressedthe results described in or implied by thosethe forward-looking statements. Thestatements contained in the following discussion should be read in conjunction with our consolidated financial statements and related notes thereto included elsewhere in this prospectus.analysis.

ResultsRESULTS OF OPERATIONS

Management’s Plans and Basis of operationsPresentation

The Company’s independent public accounting firm’s report on its financial statements as of December 31, 2011 includes a “going concern” explanatory paragraph that describes factors that raise substantial doubt about the Company’s ability to continue as a going concern. The Company’s financial statements for the year ended December 31, 2011 have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business.

The Company has experienced significant recurring losses from operations and negative cash flows from operations, and at Decemberoperations. At March 31, 20112013, the Company had cash and liquid investments of $3,971,000,approximately $9,268,000, working capital of $2,249,000, total shareholders’approximately $6,335,000, stockholders’ equity of $3,826,000approximately $8,373,000 and an accumulated deficit of $65,021,000.approximately $77,035,000. To date, the Company has in a large part relied on equity financing to fund its operations. We expectThe Company expects to continue to incur losses from operations for the near-term and these losses could be significant as we incur product development, contractclinical and regulatory activities, initial commercial and marketing activities, consulting expenses and other product development related expenses. We believeexpenses are incurred. The Company believes that ourits current working capital position will not be sufficient to meet ourits estimated cash needs for the remainder of 2012. These factors raise substantial doubt about the Company’s ability to continue as a going concern.2013 and at least into 2014. If the Company does not obtain additional capital, or financing, then the Company would potentially be required to reduce the scope of its research and development and general and administrative expenses and may not be ableactivities or cease operations. The Company continues to continue in business. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that might result in the possible inability of the Company to continue as a going concern.

explore obtaining additional financing. The Company is actively looking to obtain additional financing; however, there can be no assurance that the Company will be able to obtain sufficient additional financing on terms acceptable to the Company, if at all, or that they will not have significantly dilutive effect on the Company’s existing shareholders. We are closely monitoring ourits cash balances, cash needs and expense levels. The Company’s abilitySubsequent to continue asMarch 31, 2013, the Company closed on a going concern depends on the success of management’sloan to refinance its $1.6 million mortgage into a long-term obligation.

Management’s strategic plans to bridge cash shortfalls in 2012, which includesinclude the following:

continuing to advance development of the Company’s products, particularlyAPPY1;
aggressively pursuing additional capital raising activities in 2012;
continuing to advance development of the Company’s products, particularly AppyScore;
continuing to advance the strategic process to monetize the Company’s animal health business and related intellectual property;opportunities;
continuing to explore prospective partnering or licensing opportunities with complementary opportunities and technologies; and
continuing to monitor and implement cost control initiatives to conserve cash.

Revenues

Three Months Endedmonths ended March 31, 20122013 and 20112012

SalesNo sales were recorded for the three months ended March 31, 2013 as compared to the 2012 totaledperiod with $7,300 which is a $90,000 or 93% decrease from the same period in 2011.sales. The decrease in sales is primarily attributable to the Company’s previous strategic decision to suspend antigen production in 2010 and focus available scientific resources on the acute appendicitis and single-chain animaltest product development.development activities.

25


TABLE OF CONTENTS

In April 2008,July 2012, the Company entered into an Exclusive License Agreement (License Agreement) with a long termlicensee (Licensee) under which the Company granted the Licensee an exclusive royalty-bearing license to the Company’s intellectual property and commercialization agreement with Novartisother assets, including patent rights and know-how, relating to recombinant single chain reproductive hormone technology for use in non-human mammals (Company’s Animal Health to develop and launch the Company’s novel recombinant single-chain products for bovine species.Assets). The net total payments received under this agreement were recorded as deferred revenue and wasare being recognized as revenue over future periods through 2020. In November 2011, the Company entered into a Termination Agreement with Novartis which terminated future revenue related to the license agreement. Accordingly, the Company did not recognize any revenue related to the license agreement inperiods. During the three months ended March 31, 2012. During the three month period ended March 31, 2011, $18,0002013, $18,655 of such license payments was recognized.recognized as revenue.

Year 2012 compared to Year 2011

Sales of the Company’s antigen products for the year ended December 31, 2012, totaled $42,000, which was a $178,000 or 81% decrease from the 2011 period. The decrease in sales is primarily attributable to the Company’s previous strategic decision to terminate antigen production and focus available scientific resources


TABLE OF CONTENTS

onAPPY1 product development. Three customers accounted for $34,000 of the total 2012 sales and individually represented 40%, 30%, and 13% of such sales.

Cost of sales for the three monthsyear ended MarchDecember 31, 2012 totaled $200 which is a $12,600 decrease asdecreased by $15,800 compared to the same period in 2011.2011 period. As a percentage of sales, gross profit was 97%99% in the 2012 period as compared to gross profit of 87%93% in the same period in 2011. The improvement in the gross profit percentage resulted from the fact that no fixed production costs were incurred in the 20122011 period.

Year 2011 compared to Year 2010

Sales of the Company’s antigen products for the year ended December 31, 2011 totaled $219,000, which iswas a $151,000 or 41% decrease from the 2010 period. This decrease in sales is primarily attributable to the Company’s strategic decision in 2010 to suspend antigen production and focus available scientific resources on the acute appendicitis project and single-chain animal product development. Two customers accounted for $93,000 of the total 2011 sales and individually represented 28% and 14% of such sales. Antigen sales in 2012 are expected to decline significantly from the 2011 totals.

In April 2008, the Company entered into a long-term exclusive license and commercialization agreement with Novartis to develop and launch the Company’s novel recombinant single-chain products for bovine species. The total payments received under this agreement were recorded as deferred revenue and was being recognized over future periods through 2020. In November 2011, the Company entered into a Termination Agreement with Novartis Animal Health, Inc. (Novartis) which terminated futurethe Company’s 2008 license agreement and development agreement with Novartis. Accordingly, the Company did not recognize any revenue related to the Novartis license agreement. The Company recognizedagreement in the year ended December 31, 2012. During the years ending December 31, 2011 and 2010, $62,000 and $68,000 of such Novartis license payments in each of the years ended December 31, 2011 and 2010, respectively.revenue was recognized.

Cost of sales for the year ended December 31, 2011 totaled $16,000, which iswas a $342,000 or 95% decrease as compared to the 2010 period. As a percentage of sales, 2011 gross profit was 93% as compared to 3% in 2010. The improvement in the gross profit percentage resulted from $153,000 in inventory write downs recorded in 2010 compared to $1,000 in write downs in 2011, combined with no fixed production cost incurred in the 2011 period.

Year 2010 compared to Year 2009

Sales of the Company’s antigen products for the year ended December 31, 2010 totaled $370,000, which is a $79,000 or 27% increase from the 2009 period. Four customers accounted for $215,000 of the total 2010 sales and individually represented 10%, 11%, 18% and 19% of such sales. This increase in sales is primarily attributable to the timing of customer orders as they purchased on-hand stock of inventory. In late 2009, the Company made a strategic decision to suspend antigen production and focus available scientific resources on the acute appendicitis project and single-chain animal product development.

In April 2008, the Company entered into a long-term exclusive license and commercialization agreement with Novartis to develop and launch the Company’s novel recombinant single-chain products for bovine species. The total payments received under this agreement were recorded as deferred revenue and was being recognized over future periods through 2020, with $68,000 and $64,000 of such license fee recognized in each of years ended December 31, 2010 and 2009, respectively. In December 2009, the Company entered into a termination agreement for a prior distribution agreement covering a bovine diagnostic blood test. Upon execution of the original agreement, the Company received $200,000, which had been recorded as deferred revenue. Under the termination agreement a refund of 25% ($50,000) of the development payment previously received was paid and the remaining $150,000, which was no longer subject to any conditions, was recorded as license fee income in 2009.

26


TABLE OF CONTENTS

Cost of sales for the year ended December 31, 2010 totaled $358,000, which is a $352,000 or 50% decrease as compared to the 2009 period. As a percentage of sales, 2010 gross profit was 3% as compared to a gross loss of 144% in 2009. The net decrease in cost of sales is the result of inventory write-downs in 2009 totaling $400,000 compared to write-downs in 2010 totaling $153,000 as well as the allocation of certain fixed overhead production costs to cost of sales in 2009, which were not allocated in the 2010 period as no production runs of antigen products were made in 2010.

Selling, General and Administrative Expenses

Three Months Endedmonths ended March 31, 20122013 and 20112012

Selling, general and administrative expenses in the three months ended March 31, 2013 totaled $1,428,000, which was a $224,000 or 19% increase as compared to the 2012 period. Commercialization and marketing expenses increased by approximately $132,000 in the 2013 period as the Company advanced on its product commercialization strategy. During the three months ended March 31, 2013 expenses associated with legal fees incurred on contractual matters increased by approximately $33,000.

Year 2012 compared to Year 2011

Selling, general and administrative expenses in the year ended December 31, 2012, totaled $1,205,000,$5,185,000, which iswas a $399,000$390,000 or 25%7% decrease as compared to the 2011 period. A reduction in personnel from 2011 to 2012 resulted in a decrease in compensation related costs of approximately $205,000.$307,000. Total stock-based compensation and non-qualified option expenses were approximately $151,000$419,000 lower in the 2012 period, primarily due to fewerlower values associated with options being granted in 2012. During the three monthsyear ended MarchDecember 31, 2012, the expenses associated with legal and accounting fees decreased $39,000by $66,000 and expenses associated with being a public company decreased by $68,000. These decreases were offset by an increase of $495,000 in expenses associated with marketing and commercialization activities werein 2012. Insurance costs increased by approximately $48,000 higher than in the same period in 2011.$74,000 due generally to normal price increases.

Year 2011 compared to Year 2010

Selling, general and administrative expenses in the year ended December 31, 2011, totaled $5,575,000, which iswas a $1,842,000 or 25% decrease as compared to the 2010 period. Total stock-based compensation and non-qualified option expenses decreased $1,044,000 in 2011 primarily due to fewer options being granted combined with lower computed Black-Scholes values attributable to the options granted. Compensation expenses also decreased $359,000 in 2011 due to lower employee costs including a reduced amount accrued for incentive pay in the 2011 period compared to the 2010 period. Expenses associated with public company costs decreased $379,000 in 2011 and legal fees decreased $104,000 compared to 2010.

Year 2010 compared to Year 2009


Selling, general and administrative expenses in the year ended December 31, 2010 totaled $7,418,000, which is a $1,365,000 or 23% increase as compared to the 2009 period. Hiring of additional management personnel to advance the AppyScore product resulted in approximately $329,000 of additional expenses in the 2010 period. Approximately $611,000 in additional stock-based compensation expense was recorded in 2010 over 2009 amounts, which included $106,000 related to options granted to animal health advisory board members. Selling, general and administrative expenses also increased by $213,000 in insurance related costs primarily due to increased medical benefits costs and increases in the Company’s insurance limits and public company expense increased by $167,000 in 2010.TABLE OF CONTENTS

Research and Development

Three Months Endedmonths ended March 31, 20122013 and 20112012

Research and development expenses in the three months ended March 31, 20122013 totaled $677,000,$1,412,000, which iswas approximately a $595,000$735,000 or 47% decrease109% increase as compared to the same period in 2011.2012 period. Appendicitis test development and research expenses decreasedincreased by approximately $443,000$574,000 in the period ended March 31, 20122013 as compared to the same period in 2011,2012, due primarily to reductions in investigational work.commencement of clinical trial activities. Expenses incurred for the single-chain animal product development decreased by approximately $223,000$12,000 in the first quarter of2013 period.

Year 2012 periodcompared to Year 2011

Research and development expenses in the year ended December 31, 2012 totaled $3,838,000, which was a $1,828,000 or 32% decrease as compared to the same2011 period.APPY1 test development and research expenses in 2012 decreased by approximately $1,238,000, as compared to 2011 expenses. This decrease included a decrease of approximately $1,006,000 in reduced expenses for development of the cassette and reader expenses inclusive of reduced regulatory costs and additional marker discovery efforts and approximately $232,000 related to reduced clinical trial costs as the 2011APPY1 clinical pilot trial was completed in 2011. Expenses incurred for the single-chain animal product development decreased by approximately $353,000 in the 2012 period in 2011.following the execution of the animal health license agreement. Patent related expenses, including patent impairment expenses in the first quarter of 2012 increaseddecreased by approximately $10,000 from the same quarter of 2011.$239,000 over 2011 amounts.

Year 2011 compared to Year 2010

Research and development expenses in the 2011 period totaled $5,666,000, which iswas a $446,000 or 7% decrease as compared to the 2010 period. The completion of the Enzyme Linked Immunosorbant Assay (ELISA) based appendicitis clinical trial in mid-2010 resulted in a $1,269,000 decrease which was offset by $1,030,000 in expenses in 2011 for the AppyScoreAPPY1 pilot trial. Discovery efforts related to the identifying additional markers for the appendicitis test increased expenses by approximately $488,000 compared to the 2010 period and general appendicitis research decreased $131,000 in the 2011 period. Expenses incurred for the single-chain animal product development decreased by approximately $963,000 in the 2011 period due to

27


TABLE OF CONTENTS

lower expenses associated with the shared development costs under the Novartis agreement. Research and development expense increased by $250,000 for salaries primarily related to development activities on the appendicitis test and related discovery work. Amortization expenses associated with patents in 2011 increased by $162,000, over 2010 expenses primarily due to patent and trademark amortization and write-offs.

Year 2010 compared to Year 2009

Research and development expenses in the 2010 period totaled $6,112,000, which is a $3,179,000 or 34% decrease as compared to the 2009 period. Development efforts and advances on the acute appendicitis test, including product development advances, clinical trial and regulatory related activities comprised the primary expenses. Clinical trial and regulatory related expenses were approximately $1,130,000 lower in the year ended December 31, 2010 primarily due to the fact that in 2009 one AppyScore clinical trial was completed and a second clinical trial that commenced in the second half of 2009 was completed in early 2010. Development expenses incurred for advances on the cassette and reader program were approximately $1,448,000 lower in 2010 as compared to 2009, primarily due to substantial completion of development activities by the firms engaged in product development. Expenses incurred in connection with product and market related studies were approximately $340,000 lower in 2010 as compared to 2009. Hiring of additional scientific personnel for product development resulted in approximately $103,000 of additional expenses in the 2010 period. Direct development expenses on the single-chain animal health products increased by approximately $41,000 in the 2010 period. Amortization expenses during the 2010 period decreased by $384,000 as compared to 2009 amounts which included impairment charges for patents related to terminating an agreement with Merial Limited and management’s decision to not pursue patents specific to certain small market countries.

Other Income and Expense

Three Months Endedmonths ended March 31, 20122013 and 20112012

Primarily as a result of the lowerhigher levels of cash and reduced investment returns for the three months ended March 31, 20122013 as compared to the same2012 period, in 2011, interest income of approximately $2,000$13,000 was earned in the first quarter of 20122013 as compared to $8,000$2,000 in the same period of 2011.2012. Interest expense for the three months ended March 31, 2013, decreased to $44,000, compared to $67,000 in the 2012 period. During the three-month period ended March 31, 2013, the Company received income of approximately $50,000 in connection with a redemption of its current mutual insurance company.

Year 2012 compared to Year 2011

Interest and other expense for the year ended December 31, 2012, increased to $67,000,an expense of $251,000, compared to $45,000income of $762,000 in the same period of 2011.2011 period. The increase in interest expense is primarily due to imputed interest expense under the Novartis Animal Health Termination Agreement.Agreement and the financing of certain insurance obligations. Other income in 2011 included a gain of approximately $939,000 resulting from the Termination Agreement with Novartis.

Year 2011 compared to Year 2010

In 2011, other income includesincluded a gain of approximately $939,000 resulting from the Termination Agreement with Novartis. Under the Termination Agreement, the Company’s liabilities associated with the Novartis arrangements exceeded theits net settlement payable to Novartis, resulting in a gain on the contract termination, net of related legal fees incurred of approximately $7,500.


TABLE OF CONTENTS

Primarily as a result of lower average cash and investment balances in 2011 as compared to 2010, interest income of approximately $16,000 was earned in 2011 as compared to $62,000 in 2010. Interest expense for the year ended December 31, 2011, increased to $197,000, compared to $194,000 the 2010 year. The increase in interest expense iswas primarily due to the financing of certain insurance premiums.

Year 2010 compared to Year 2009

Primarily as a result of lower average cash and investment balances in 2010 as compared to 2009, interest income of approximately $62,000 was earned in 2010 as compared to $189,000 in 2009. Interest expense for the year ended December 31, 2010 decreased to $194,000, or $6,000 less as compared to the 2009 year. The decrease was primarily due to lower debt levels resulting from scheduled principal repayments.

Income Taxes

No income tax benefit was recorded on the net loss for the three months ended March 31, 2013 and 2012, as management was unable to determine that it was more likely than not that such benefit would be realized.

No income tax benefit was recorded on the loss for the year ended December 31, 2012, as management of the Company was unable to determine that it was more likely than not that such benefit would be realized. At MarchDecember 31, 2012, the Company had a net operating loss carry forwards for income tax purposes of approximately $63$68 million, expiring through 2031.2032.

28


TABLE OF CONTENTS

Liquidity and capital resourcesLIQUIDITY AND CAPITAL RESOURCES

At March 31, 2012,2013, we had working capital of $437,000,$6,335,000, which included cash, cash equivalents and short term investments of $1,878,000.$9,268,000. We reported a net loss of $1,938,000$2,802,000 during the three months ended March 31, 2012,2013, which included $376,000$552,000 in net non-cash expenses relating toincluding stock-based compensation totaling $484,000 and depreciation and amortization totaling $87,000, net of $222,000 and $154,000 for depreciation, amortization and impairment charges.of license fee of $19,000.

Currently, our primary focus is to continue the development activities on our acute appendicitis diagnostic test, including advancement of such test with the steps required for FDA clearance, as well as advancing on commercialization and to advancemarketing activities following the strategic process to monetize our animal health business and related intellectual property.recent attainment of CE marking in the E.U.

We expect to continue to incur losses from operations for the near-term and these losses could be significant as we incur product development, clinical and regulatory activities, contract consulting and other product development and commercialization related expenses. We believe that our current working capital position will not be sufficient to meet our estimated cash needs for the remainder of 2012. These factors raise substantial doubt about the Company’s ability to continue as a going concern. If the Company does not obtain additional capital, then the Company would potentially be required to reduce the scope of its research2013 and development and general and administrative expenses and may not be able to continue in business.at least into 2014. The Company is actively looking to obtainpursuing additional financing;financing opportunities; however, there can be no assurance that the Company will be able to obtain sufficient additional financing.financing on terms acceptable to the Company, if at all. We are closely monitoring our cash balances, cash needs and expense levels. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that might result in the possible inability of the Company to continue as a going concern.

Capital expenditures, primarily for production, laboratory and facility improvement costs for the fiscal year ending December 31, 2012 are anticipated to total less than $100,000. We anticipate these capital expenditures to be financed through working capital.

We anticipate that expenditures for research and development for the fiscal year ending December 31, 2012 will decrease compared to the amounts expended in 2011. Development and testing costs in support of the current AppyScore product as well as costs to file patents and revise and update previous filings on our technologies will continue to be substantial. As we continue towards commercialization of these products, including evaluation of alternatives for possible product management and distribution alternatives and implications of product manufacturing and associated carrying costs such evaluation and related decisions will impact our future capital needs. Certain costs such as manufacturing and license/royalty agreements have different financial, logistical and operational implications depending upon the ultimate strategic commercialization path determined.

We expect that our primary development expenditures will be to continue enrollment of our FDA clinical trial forAPPY1and to advance product developmentsupport commercialization and testingmarketing activities of our appendicitis test in Europe following the cassette and instrument versionrecent successful completion of AppyScore.CE marking. Based upon our experience, clinical trial expenses can be significant costs. During the yearsthree month periods ended DecemberMarch 31, 2011, 2010,2013 and 2009,2012, we expended approximately $3,388,000, $3,371,000$871,000 and $6,290,000,$277,000, respectively, in direct costs for AppyScore APPY1development and related clinical and regulatory efforts. Steps to achieve commercialization of the acute appendicitis product will be an ongoing and evolving process with expected improvements and possible subsequent generations and expected improvements being made inevaluated for the test. Should we be unable to achieve FDA clearance of the AppyScore APPY1appendicitis test andor generate sufficient revenues from the product, we would need to rely on other business or product opportunities to generate revenues and costs that we have incurred for the acute appendicitis patent may be deemed impaired.

The ExclusiveIn November 2011, the Company entered into the Novartis Termination Agreement to terminate the
2008 Novartis License Agreement. Under the Novartis Termination Agreement, the termination obligation totaled $1,374,000, and at March 31, 2013, the remaining outstanding termination obligation totaled approximately $201,000 which is due in June 2013.

During July 2012, the Company entered into a License Agreement (WUwith the Licensee, under which the Company granted the Licensee an exclusive royalty-bearing license to the Company’s Animal Health Assets. The License Agreement) between AspenBio and WU was entered into effective May 1, 2004, and grants AspenBio exclusive license and rightAgreement includes a sublicense of the technology licensed to sublicense WU’s technology (as defined under the WU License Agreement) for veterinary products worldwide, except where such products are prohibited under U.S. laws for export. The termCompany by Washington University of St. Louis, or WU. Under the terms of the WU License Agreement, continues until the expirationa portion of the last of WU’s patents (as defined in the WU License Agreement) to expire. AspenBio has agreed to pay minimum annual royalties of $20,000 annually during the term of the WU License Agreementlicense fees and such amounts are creditable against future royalties. Royalties payable to WU under the WU License Agreement for covered product sales by AspenBio carry a mid-single digit royalty rate and for sublicense fees received by AspenBio carry a low double-digit royalty rate. The WU License Agreement contains customary terms for confidentiality, prosecution and infringement provisions for licensed patents, publication rights, indemnification


29


 

TABLE OF CONTENTS

royalties Venaxis receives from sublicensing agreements will be paid to WU. Obligation for any license fees due to WU is included in accrued expenses at March 31, 2013.

and insurance coverage. The WUUnder the License Agreement, is cancelableas of March 31, 2013, the following future license fees and milestone payments will be paid to the Company, assuming future milestones are successfully achieved by AspenBio with ninety days advance notice at any time and by WU with sixty days advance notice if AspenBio materially breaches the WU License Agreement and failsLicensee:

license fees of $204,000 payable in June 2013;
milestone payments, totaling up to cure such breach.

Our animal health technology, licensed from Washington University in St. Louis (WU) in 2004 and further developed at AspenBio, has been used to develop reproduction drugs, initially applieda potential of $1.1 million in the bovine species, to be followed by other livestock species of economic importance. The bovine drugs were sub-licensed in 2008 to Novartis Animal Health (“NAH” or “Novartis”) under a long-term world-wide development and marketing agreement. Between 2008 and 2011, substantial investment and progress in product, regulatory and clinical activities were madeaggregate, based on the bovine drug products. A pilot study was completed during late 2010 using the bovine LH drug and subsequently NAH informed us that preliminary pilot study results revealed that the pilot study did not demonstrate the outcomessatisfactory conclusion of milestones as defined in the success criteria, and NAH had requested a refundLicense Agreement;

potential for milestone payments of the contingent $900,000 milestone payment that was tiedup to the pilot study outcome and notified us that they wished to terminate the agreement. On November 15, 2011, AspenBio and Novartis executed a Termination and Settlement Agreement (“Novartis Termination Agreement”) that providedan additional $2 million for the termination of the existing agreements between the Company and NAH. Under the terms of the Novartis Termination Agreement, the Company will pay to NAH the refundable $900,000 milestone payment and a negotiated amount totaling $475,000 of the Company’s portion of net shared development expenses. The settlement amount is payable in quarterly installments commencing upon execution of the Novartis Termination Agreement and for the following six fiscal quarters. Upon execution of the Novartis Termination Agreement, the Company gained access to and use of all development and research materialsreceipt of regulatory approval for additional licensed products; and protocols developed under the prior NAH agreements. All
royalties, at low double digit rates, based on sales of NAH’s rights under the prior agreements will be terminated in full once the Company pays the settlement amount in full.

licensed products.

We have entered and expect to continue to enter into additional agreements with contract manufacturers for the development/development and manufacture of certain of our products for which we are seeking FDA approval. The goal of this development process is to establish current good manufacturing practices (cGMP) required for those products for which we are seeking FDA approval. These development and manufacturing agreements generally contain transfer fees and possible penalty and/orand royalty provisions shouldif we transfer our products to another contract manufacturer. We expect to continue to evaluate, negotiate and execute additional and expanded development and manufacturing agreements, some of which may be significant commitments during 2012.commitments. We may also consider acquisitions of development technologies or products, shouldif opportunities arise that we believe fit our business strategy and would be appropriate from a capital standpoint.

Capital expenditures, primarily for production, laboratory and facility improvement costs for remainder of the year ending December 31, 2013 are anticipated to total approximately $75,000 to $125,000. We anticipate these capital expenditures to be financed through working capital.

The Company periodically enters into in general,generally short-term consulting and development agreements primarily for product development, testing services and in connection with clinical trials conducted as part of the Company’s FDA clearance process. Such commitments at any point in time may be significant but the agreements typically contain cancellation provisions.

We have a permanent mortgage facility on our land and building that commenced in July 2003. The mortgage is held by a commercial bank and includes a portion guaranteed by the U.S. Small Business Administration (SBA).Administration. Effective April 8, 2013, we entered into the Modification Agreement with the Bank to refinance the outstanding commercial loan for which the remaining principal balance of approximately $1.6 million was due in July 2013. The loan is collateralized by the real propertyproperty. The Modification Agreement extends the maturity date to April 2018 and is also personally guaranteed by a former officer ofreduces the Company. The interest rate on the bank portion is one percentageto a fixed interest rate of 3.95% from a variable rate equal to 1% over theThe Wall Street Journal Prime Rate (minimum 7%), with 7% being the approximate effective rate, and the SBA portion bears interest at the(with a minimum rate of 5.86%7%). The commercial bank portionloan terms include a payment amortization period of the loan requires totalfifteen years, with a balloon maturity at five years with monthly payments of approximately $14,200, which includes approximately $9,200 per month in contractual interest, through June 2013, when$11,700. The portion of the then remaining principal balance is duebuilding mortgage guaranteed by the SBA, which is estimated to be approximately $1,607,000 at that time.34% of the current loan total, remains unaffected by the Modification Agreement. The SBA portion of the loan requires total monthly payments of approximately $9,200 through July 2023, which currently includes approximately $4,200$4,100 per month in contractual interest and fees.

In April 2008, the Board authorized a stock repurchase plan to purchase shares of our common stock up to a maximum of $5.0 million. Purchases may be made in routine, open market transactions, when management determines to effect purchases and any purchased shares of common stock are thereupon retired. Management may elect to purchase less than $5.0 million. The repurchase program allows us to repurchase our shares in accordance with the requirements of the Securities and Exchange Commission (SEC) on the open market, in block trades and in privately negotiated transactions, depending upon market conditions and other factors. A

30


TABLE OF CONTENTS

total of approximately 46,400 common shares were purchased and retired in 2008 at a total cost of approximately $992,000. No repurchases have been made since 2008.

With the recent changes in market conditions, combined with our conservative investment policy and lower average investable balances due to cash consumption, we expect that our investment earnings in 2012 will be lower than in 2011. The Board has approved an investment policy covering the investment parameters to be followed with the primary goals being the safety of principal amounts and maintaining liquidity of the fund. The policy provides for minimum investment rating requirements as well as limitations on investment duration and concentrations. Commencing in the fourth quarter of 2008, based upon market conditions, the investment guidelines were tightened to raise the minimum acceptable investment ratings required for investments and shorten the maximum investment term. Current investment guidelines require investments to be made in investments with minimum ratings purchasing commercial paper with an A1/P1 rating, longer-term bonds with an A- rating or better, a maximum maturity of nine months and a concentration guideline of 10%, with no security or issuer representing more than 10% of the portfolio upon purchase. As of December 31, 2011, 64% of the investment portfolio was in cash equivalents which are included with cash and the remaining funds were invested in short-term marketable securities with none individually representing more than 16% of the portfolio and none maturing past June 2012. To date, we have not experienced a cumulative market loss from the investments that has exceeded $5,000.

Due to recent market events that have adversely affected all industries and the economy as a whole, management has placed increased emphasis on monitoring the risks associated with the current environment, particularly the investment parameters of the short term investments, the recoverability of current assets, the fair value of assets, and the Company’s liquidity. At this point in time, there has not been a material impact on the Company’s assets and liquidity. Management will continue to monitor the risks associated with the current environment and their impact on the Company’s results.


TABLE OF CONTENTS

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements.

Operating Activities

Net cash consumed by operating activities was $1,735,000$2,472,000 during the three months ended March 31, 2012.2013. Cash was consumed by the loss of $1,938,000,$2,802,000, less non-cash expenses of $222,000$484,000 for stock-based compensation and $154,000$87,000 for depreciation amortization and impairment charges.amortization. For the three months ended March 31, 2012,2013, decreases in accounts receivable and prepaid and other current assets of $137,000$101,000 provided cash, primarily related to routine changes in operating activities. A net decrease of $310,000$98,000 in accounts payable and accrued expenses consumed cash from operating activities, primarily related to the payment of liabilities associated with2012 incentive plan amount paid in 2013, offset by increased costs accrued on the completionAPPY1trial in 2013. Cash provided by operations included an increase of approximately $197,000 in deferred revenue, following the execution of the AppyScore pilot trialLicense Agreement for the Company’s animal health assets.

Net cash consumed by operating activities was $5,489,000 during the year ended December 31, 2012. Cash was consumed by the loss of $9,212,000, less non-cash expenses of $931,000 for stock-based compensation, depreciation and amortization totaling $430,000 and impairment and other items, net totaling $26,000. For the year ended December 31, 2012, decreases in late 2011.accounts receivable generated cash of $35,000. Decreases in prepaid and other current assets of $408,000 provided cash, primarily related to routine changes in operating activities. There was a $306,000 increase in accounts payable and accrued expenses in the year ended December 31, 2012, primarily due to increases in the activity levels at year end for the Company’sAPPY1 clinical, regulatory, and marketing activities. An increase of $405,000 in accrued compensation provided cash. Cash provided by operations included an increase of $1,182,000 in deferred revenue, following the execution of the License Agreement for the Company’s animal health assets.

Net cash consumed by operating activities was $8,333,000 during the year ended December 31, 2011. Cash was consumed by the loss of $10,214,000, less net non-cash expenses of $1,093,000, including stock-based compensation totaling $1,336,000, $491,000 for depreciation and amortization, impairment and related charges totaling $275,000 and a $939,000 non-cash gain related to the Novartis Termination Agreement. For the year ended December 31, 2011, a $38,000 decrease in accounts receivable associated with lower antigen sales generated cash. A decrease in prepaid and other current assets of $427,000 provided cash, primarily related to routine changes in operating activities. Cash increased from an increase of $292,000 in accounts payable, net of the non-cash adjustment of $837,000 decreasing the accounts payable balance associated with the Novartis Termination Agreement settlement. Accrued expenses that decreased $31,000 in the year ended December 31, 2011 also generated cash, primarily due to a combination of an increase in accrued expenses related to AppyScoreAPPY1 pilot trial expenses and a decrease of $180,000 in accrued compensation, due to a decrease in amounts accrued for incentive pay for the 2011 period.

Net cash consumed by operating activities was $10,707,000 during the year ended December 31, 2010. Cash was consumed by the loss of $13,338,000, less non-cash expenses totaling $2,895,000 relating to stock-based compensation totaling $2,364,000 and depreciation and amortization totaling $492,000 and other items net, which totaled $39,000. In late 2009, we substantially suspended the production of antigen products as a result of our strategic decision to focus available scientific resources on acute appendicitis and single-chain animal

31


TABLE OF CONTENTS

product development. As a result of this decision we recorded a write down of approximately $153,000 in antigen inventories in 2010. Due to the suspension of antigen sales the net investment in accounts receivable and inventories, decreased by $297,000 in 2010 generating cash including the inventory write down of approximately $153,000. A decrease in prepaid and other current assets of $81,000 provided cash, primarily related to routine changes in operating activities. Cash used by operations included a $642,000 reduction in accounts payable and accrued expenses in 2010, primarily due to the decrease in expenses related to the recent completion of the Company’s AppyScore2010APPY1 clinical trial.

Net cash consumed by operating activities was $11,364,000 during the year ended December 31, 2009. Cash was consumed by the loss of $15,518,000, less net non-cash expenses totaling $2,462,000, for stock-based compensation of $1,715,000, impairment and related charges of $573,000 and depreciation and amortization expenses of $388,000, net of amortized license fee revenues of $214,000. Included in the 2009 impairment charges is $565,000 in patent impairment costs related to terminating an agreement with Merial Limited and to not pursuing patents specific to certain countries that were determined to be not economically beneficial. A decrease in accounts receivable of $15,000 provided cash resulting from lower base antigen sales levels. Inventory levels decreased by a net $233,000, arising from net sales activities and the write down of antigen based inventory to lower of cost or market. In late 2009, we substantially suspended the production of antigen products as a result of its strategic decision to focus available scientific resources on acute appendicitis and single-chain animal product development. As a result of this decision, we recorded an approximately $400,000 write down in antigen inventories. Cash consumed in operations was reduced by the net increase of $830,000 in accounts payable and accrued expenses, primarily due to the increase in year-end accrued expenses.

Investing Activities

Net cash inflowsoutflows from investing activities generated $418,000consumed $5,653,000 during the three months ended March 31, 2012. Sales2013. Purchases of marketable securitiesshort-term investments totaled approximately $441,000.$5,613,000. A $23,000$29,000 use of cash was attributable to additional costs incurred from patent filings.filings and approximately $11,000 was incurred from purchases of property and equipment.


TABLE OF CONTENTS

Net cash outflows from investing activities consumed $316,000 during the year ended December 31, 2012. Sales of marketable securities investments totaled approximately $2,832,000 and marketable securities purchased totaled approximately $2,992,000. Cash totaling $156,000 was used for additions to capitalized patent filings and equipment additions.

Net cash inflows from investing activities generated $1,611,000 during the year ended December 31, 2011. Marketable securities investments purchased totaled approximately $1.0 million and marketable securities sold totaled approximately $3.0 million. Cash totaling $228,000 was used for additions to patents and additions to equipment totaling $90,000.

Net cash outflows from investing activities consumed $2,923,000 during the year ended December 31, 2010. Marketable securities investments acquired totaled approximately $7.6 million and sales of marketable securities totaled approximately $5.2 million. Cash was used for additions to intangibles of $310,000 for costs incurred from patent filings and equipment additions totaling $192,000.

Net cash inflows from investing activities generated $4,533,000 during the year ended December 31, 2009. Marketable securities investments acquired totaled approximately $2.3 million and sales of marketable securities totaled approximately $7.4 million. Cash totaling $596,000 was used in additions to intangibles of $352,000 for costs incurred from patent filings and equipment additions totaling $244,000 for additions and expansion of lab equipment and facilities.

Financing Activities

Net cash outflows from financing activities consumed $335,000$361,000 during the three month period ended March 31, 20122013 for repayments under existing debt agreements.

Net cash inflows from financing activities generated $13,815,000 during the year ended December 31, 2012. The Company received net proceeds of $15,146,000 from the sale of common stock in public offerings of securities and repaid $1,331,000 in scheduled payments under its debt agreements including payments under the Novartis Termination Agreement.

Net cash inflows from financing activities generated $782,000 during the year ended December 31, 2011. The Company received net proceeds of $1,456,000 from the sale of common stock in a December 2011 registered direct offering and repaid $674,000 in scheduled payments under its debt agreements.

Net cash inflows from financing activities generated $9,171,000 during the year ended December 31, 2010. The Company received net proceeds of $9,117,000 from the sale of common stock and $291,000 in proceeds from the exercise of stock options. The Company repaid $236,000, in scheduled payments under its debt agreements.

32


TABLE OF CONTENTS

Net cash inflows from financing activities generated $8,378,000 during the year ended December 31, 2009. The Company received net proceeds of $8,260,000 from an offering of common stock and $469,000 in proceeds from the exercise of stock warrants and options. The Company repaid $351,000 in scheduled payments under its debt agreements.

Critical Accounting Policies

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (GAAP) requires management to make estimates and assumptions about future events that affect the amounts reported in the financial statements and accompanying notes. Future events and their effects cannot be determined with absolute certainty. Therefore, the determination of estimates requires the exercise of judgment. Actual results inevitably will differ from those estimates, and such differences may be material to the financial statements. The most significant accounting estimates inherent in the preparation of our financial statements include estimates associated with revenue recognition, impairment analysis of intangibles and stock-based compensation.

The Company’s financial position, results of operations and cash flows are impacted by the accounting policies the Company has adopted. In order to get a full understanding of the Company’s financial statements, one must have a clear understanding of the accounting policies employed. A summary of the Company’s critical accounting policies follows:

Investments:  The Company invests excess cash from time to time in highly liquid debt and equity securities of highly-ratedhighly rated entities which are classified as trading securities. Such amounts are recorded at market and are classified as current, as the Company does not intend to hold the investments beyond twelve months. Such excess funds are invested under the Company’s investment policy but an unexpected decline or loss could have an adverse and material effect on the carrying value, recoverability or investment returns of such investments. Our Board has approved an investment policy covering the investment parameters to be followed with the primary goals being the safety of principal amounts and maintaining liquidity of the fund. The policy provides for minimum investment rating requirements as well as limitations on investment duration and concentrations.


TABLE OF CONTENTS

Intangible Assets:  Intangible assets primarily represent legal costs and filings associated with obtaining patents on the Company’s new discoveries. The Company amortizes these costs over the shorter of the legal life of the patent or its estimated economic life using the straight-linestraightline method. The Company tests intangible assets with finite lives upon significant changes in the Company’s business environment. The testing resulted in approximately $275,000, $107,000 and $565,000 ofno patent impairment charges during the three months ended March 31, 2013, $42,000 for the three months ended March 31, 2012 and $45,000, $275,000 and $175,000 for the years ended December 31, 2012, 2011 2010 and 2009,2010, respectively.

Long-Lived Assets:  The Company records property and equipment at cost. Depreciation of the assets is recorded on the straight-line basis over the estimated useful lives of the assets. Dispositions of property and equipment are recorded in the period of disposition and any resulting gains or losses are charged to income or expense when the disposal occurs. The Company reviews for impairment whenever there is an indication of impairment. The required annual testing resulted in no impairment charges being recorded to date.

Revenue Recognition:  The Company’s revenues are recognized when products are shipped or delivered to unaffiliated customers. The Securities and Exchange Commission’sSEC’s Staff Accounting Bulletin (SAB) No. 104, provides guidance on the application of generally accepted accounting principles to select revenue recognition issues. The Company has concluded that its revenue recognition policy is appropriate and in accordance with SAB No. 104. Revenue is recognized under developmentsales, license and distribution agreements only after the following criteria are met: (i) there exists adequate evidence of the transactions; (ii) delivery of goods has occurred or services have been rendered; and (iii) the price is not contingent on future activity and (iv) collectability is reasonably assured.

Stock-based Compensation:  ASC 718, (formerly — SFAS No. 123(R)),Share-Based Payment, defines the fair-value-based method of accounting for stock-based employee compensation plans and transactions used by the Company to account for its issuances of equity instruments to record compensation cost for stock-based employee compensation plans at fair value as well as to acquire goods or services from non-employees. Transactions in which the Company issues stock-based compensation to employees, directors and consultants

33


TABLE OF CONTENTS

and for goods or services received from non-employees are accounted for based on the fair value of the equity instruments issued. The Company utilizes pricing models in determining the fair values of options and warrants issued as stock-based compensation. These pricing models utilize the market price of the Company’s common stock and the exercise price of the option or warrant, as well as time value and volatility factors underlying the positions.

Recently issuedIssued and adopted accounting pronouncements:Adopted Accounting Pronouncements:

The Company has evaluated all recently issued accounting pronouncements and believes such pronouncements upon their adoption willdo not have a material effect on the Company’s financial statements.

Reclassifications:

Certain prior period amounts in the accompanying financial statements have been reclassified to conform to the presentation used in 2012.

Quantitative and Qualitative Disclosure About Market Risk

General:  We have limited exposure to market risks from instruments that may impact theBalance Sheets,Statements of Operations, andStatements of Cash Flows. Such exposure is due primarily to changing interest rates.

Interest Rates:  The primary objective for our investment activities is to preserve principal while maximizing yields without significantly increasing risk. This is accomplished by investing excess cash in highly liquid debt and equity investments of highly rated entities which are classified as trading securities. As of March 31, 2013, approximately 24% of the investment portfolio was in cash and cash equivalents with very short term maturities and therefore not subject to any significant interest rate fluctuations. We have no investments denominated in foreign currencies and therefore our investments are not subject to foreign currency exchange risk.

34



 

TABLE OF CONTENTS

BUSINESS

Overview

AspenBio Pharma, Inc. (the “Company” or “AspenBio” also “we”, “us” or “our”)Venaxis is focused on advancing products that address unmet human diagnostic and animal health therapeutic needs. AspenBio wasWe were formed in August 2000 as a Colorado corporation to produce purified proteins for diagnostic applications. WeTo date, we have leveraged our science and technology to develop a number of product candidates.

The Company’s primary focus is on advancing AppyScoreTM, its human diagnostic test to aid in the risk management of acute appendicitis in pediatric and adolescent populations, toward commercialization. AppyScore is a proprietary blood-based diagnostic test that, if successfully cleared for marketing in the United States by the U.S. Food and Drug Administration (FDA), and CE marked for the European Union, we believe will provide emergency department physicians a valuable and objective tool to aid in the risk management of patients suspected of having acute appendicitis. We expect AppyScore to be useful in the diagnostic evaluation of patients based on the test’s high sensitivity and negative predictive value, which could provide physicians with additional information to help manage patients who are at low risk of having acute appendicitis without using expensive imaging and potentially exposing the patient to unnecessary radiation. We intend to pursue clinical testing to support FDA clearance under FDA’s de-Novo 510(K) process for AppyScore for use in the risk management of children adolescents and young adults (ages 2 – 20) presenting in the emergency departments of hospitals with abdominal pain suggestive of an acute appendicitis.

Our animal health productadvance development efforts are directed toward the creation of reproduction drugs for the enhancement of animal fertility. The initial focus is for use in the cattle industry, to be followed by other livestock species of economic importance. The cattle therapeutics were sub-licensed in 2008 to Novartis Animal Health (NAH or Novartis) under a long-term world-wide development and marketing agreement. Following the failure of pilot study testing to meet defined success criteria, in November 2011, AspenBio and Novartis entered into a termination agreement and, subject to agreed upon conditions, including specified payments being made by AspenBio, product rights and technology returns to AspenBio. As a result of our decisionAPPY1 product candidate and to focus on the human AppyScore test development activities,develop animal health-related assets, including intellectual property. In 2012, we are currently advancing in a strategic processout-licensed these animal health-related assets and changed our name to monetize our animal health business and related intellectual property, with the goal of entering into a transaction or license agreement with a third party, which will most likely be a company currently in the animal health industry, who would take over product development and commercialization.Venaxis, Inc. from AspenBio Pharma, Inc.

Product Overview

Our business strategy is to focus on products and technologies whichthat we believe have attractive worldwide markets and significant product margin potential. Our acute appendicitis test, AppyScore,APPY1, which is our current primary focus.focus, meets these objectives. We may also pursue technologies under “in-licensing” agreements with third parties such as universities, researchers or individuals; weindividuals, add value by advancing the stage of research and development on the technologies through proof of concept, and then we will either “out-license” to “big pharma” and/orglobal diagnostic companies or continue with in-house development towards regulatory approval, product introduction and launch. Presently

APPY1 is a multi-marker blood test panel intended to be used by emergency department physicians to aid them in the productsevaluation of possible acute appendicitis in our existing pipeline arechildren, adolescent and young adult patients (ages 2 – 20) who present with abdominal pain. In the United States,APPY1 is under the regulatory jurisdiction of the FDA. We are not aware of any blood test that is cleared by the FDA for the United States.

Human Diagnostics

AppyScore ispurpose of aiding in ruling out appendicitis, and are not aware of any competitors in this area. We expect that a blood-based test designedprincipal benefit ofAPPY1 will be to provide physicians with objective information that will aid in the evaluationidentification of patients presenting signswho present with abdominal pain but who are at low risk for appendicitis. Such objective information could be used by the physician to pursue more conservative treatment plans for such low-risk patients, such as avoiding or delaying the use of computed tomography (CT) scans with such patients. This could have the benefit of reducing the exposure to radiation from, and symptomsthe expense associated with, performing CT scans in such low-risk patients as part of acute appendicitis to help physicians with the difficult task of diagnosing acute appendicitisinitial assessment conducted in children, adolescents and young adults (ages 2 – 20) entering the emergency roomdepartment. In addition, we believe the test can potentially save significant costs through improved patient throughput in emergency departments.

We have completed a design freeze for ourAPPY1 product candidate and, in early 2013, commenced a 2,000 patient, multi-center prospective pivotal clinical trial to be used in connection with symptoms of the disease. The current version of AppyScore is a multi-marker blood test panel of biomarkers consisting of the Company’s patented MRP 8/14 (also known as S100A8/A9 or calprotectin)our application for FDA clearance. We also have commenced initial marketing and C-reactive protein (CRP), along with White Blood Cell count (WBC). The scoring results of these individual components will be analyzed using the company’s proprietary algorithm software embeddedcommercialization activities for our CE markedAPPY1 products in the AppyScore cassette reader, to provide an AppyScore result to the clinician. We expect AppyScore will help physicians manage those patients who are suspected of having acute appendicitis but can be determined to be at sufficiently low risk to avoid imaging procedures which are costly and potentially harmful to patients. The use of AppyScore in emergency departments could also positively impact resource utilization and improve patient management. The primary

35


TABLE OF CONTENTS

focus of our recent efforts is directed towards clinical testing to obtain sufficient data for regulatory clearance for AppyScore for the patient population consisting of children, adolescents and young adults (ages 2 – 20). We are focusing on this intended use because acute appendicitis is primarily a disease that impacts children, adolescents and young adults, and the young ages of these patients heightens the risk from exposure to radiation.European Union.

APPY1

Appendicitis Overview and Market

Appendicitis is a rapidly progressing condition whichthat typically causes increasing lower abdominal pain to increase over a period of 12 to 4836 hours from onset of symptoms to perforation.perforation of the appendix. This progressive pain period is variable, however, and can be sustained for 48 hours or more. Acute appendicitis most frequently occurs in patients aged 10 to 30, but can affect all ages. It is estimated that approximately 5 to 7% of the world’s population will get appendicitis in their lifetime with the peak age range for the disease being the early teens. To date, there appears to be no individual sign, symptom, test, or procedure capable of providing either a conclusive rule in or rule out diagnosis of acute appendicitis. In the United States alone, according to National Hospital Ambulatory Medical Care Survey (NHAMCS) data obtained from the Centers for Disease Control and Prevention (CDC) Public-use Data Files (1973 – 2009) in 2009, there were approximately 9.6 million total patients who entered emergency departments complaining of abdominal pain. Out of this total, 6.6 million had complete blood count (CBC) work-ups performed, 3.2 million underwent computed tomography (CT) imaging studies and 1.2 million underwent ultrasound procedures and approximately 300,000 of these total patients were diagnosed as having acute appendicitis and underwent appendectomies. Included in these totals were 2.1 million patients (approximately 21%) comprised of children, adolescents and young adults aged two through twenty years old. Out of this sub-population, approximately 1.1 million had CBC work-ups performed, 417,000 underwent CT imaging and 259,000 underwent ultrasound procedures. Approximately 135,000 of this group of patients were diagnosed as having acute appendicitis and underwent appendectomies.

Failure to accurately diagnose and treat acute appendicitis before perforation can lead to serious complications and, in some cases, death. The current diagnostic and treatment paradigm for acute appendicitis includes many factors, such as a review of the patient’s clinical presentation including signs and symptoms, health history, blood chemistry, temperature and white blood cell (WBC) count. In the United States,U.S., patients who are considered to be at risk for acute appendicitis are frequently sent for CT scan or ultrasound imaging for further diagnosis and then surgery if indicated. Currently the total estimated costTo date, there appears to be no individual sign, symptom, test, or procedure capable of an abdominalproviding either a conclusive rule in or pelvic CT scan plus associated fees can range from several hundred dollars to a few thousand dollars per procedure, resulting in a total estimated expenditurerule out diagnosis of over $1.0 billion annually in the United States on CT scans to diagnose acute appendicitis. A scan can take more than four hours to complete (including typical processing time) and exposes the patient to high levels of ionizing radiation. Published data indicate that in the United States approximately 12% and 7%, of, adult patients and pediatric patients, respectively, of appendectomies remove a normal appendix due primarily to incorrect diagnosis prior to surgery.

Although the use of CT scans appears to be the most widely used diagnostic tool in the United States,U.S., its results are subject to interpretation and can be inconclusive in addition to subjecting patients to large doses of radiation. Over the past decade there has been increasing concern over radiation exposure caused by imaging. In 2010, the FDA released a report titled “Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging.” Studies conducted from 2007 through 2010 and published in peer review publications provide evidence that the radiation from a single CT scan can significantly increase the risk of developing cancer later in life, that children and adolescents are especially vulnerable to the oncogenic, long term effects of exposure to high doses of ionizing radiation, such as from CT scans, and that up to 2 percent


TABLE OF CONTENTS

of all U.S. cancers will result from CT scan use. We believe that these risks, when coupled with the increased use of CT scans in abdominal pain patients, could have positive implications for a test likeAPPY1 which, if cleared, could be used to help physicians determine which patients are at low risk for the disease, leading to more conservative treatment and potentially avoiding use of CT scans. Currently, approximately 3.7 million CT scans are conducted annually on abdominal pain patients. Physicians also face the dilemma of minimizing the negative appendectomy surgery rate without increasing the incidence of a life threatening perforation among patients presenting with symptoms of suspected acute appendicitis. We expectAPPY1 will provide an additional objective tool to assist physicians in their initial clinical evaluation of patients by aiding in the identification of patients at low risk for acute appendicitis, so that the diagnostic protocols such as CT scans can be used more selectively for those patients with inconclusive test results.

It is estimated that approximately 7 to 9% of the population will be diagnosed with appendicitis in their lifetime with the peak age range for the disease being the early teens. Published data from several sources indicate that in the U.S., 3 – 15% of appendectomies remove a normal appendix primarily due to an incorrect diagnosis. Appendicitis is one of the leading causes of medical malpractice claims in the U.S. due to many factors, including high diagnostic error rates, negative appendectomies, and increased cost and complications in cases where the appendix perforates. In addition to health risks, hospital charges for unnecessary (negative) appendectomies are estimated to cost approximately $740 million annually in the U.S. alone.

Acute appendicitis most frequently occurs in patients aged 10 to 30, but can affect all ages. Using a CT scan to rule out acute appendicitis can be particularly difficult in children and young adults because many patients in these age groups have low body fat, resulting in poor tissue differentiation or contrast on the CT scan.

Over TheAPPY1 test has the past decade there has been increasing concern identified regardingpotential to enhance overall safety by reducing the amount of radiation exposure caused by radiologic tests. In 2010, the FDA released a report titled “Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging.” We believe that reports such as this FDA Report could have positive implications for a test like AppyScore which, if cleared could be used to help physicians determine which patients are at low risk for the disease and potentially avoidunnecessary CT scanning.

In addition to health risks, hospital charges for unnecessary (negative) appendectomies are estimated to cost approximately $740 million annuallyscans in the United States alone (Flum et al.low-risk patient population.

Product Description

Our currentAPPY1 product candidate is a multi-marker blood test panel of biomarkers consisting of our patented MRP 8/14 (also known as S100A8/A9 or calprotectin) and a combination of markers including C-reactive protein (CRP), Arch Surg. 2002;137:799-804). Appendicitis is onealong with WBC count. The scoring results of the leading causes of medical malpractice claimsthese individual components are analyzed using our proprietary algorithm software embedded in the United States dueAPPY reader, which is a small bioanalyzer, to many factors, including high diagnostic error rates, negative appendectomies,provide anAPPY1 result to the physician. These results are displayed on the device display screen and increased cost and complicationsalso are included on a patient print-out from the APPY reader. The test is designed to be run in cases whereapproximately 20 minutes in the appendix perforates.hospital’s clinical laboratory.

36


TABLE OF CONTENTS

Results from our development efforts, clinical trials and pilot trialsstudy performed to date indicate that the greatest potential benefit of the AppyScoreAPPY1 test would be in aiding the physician in the evaluation of those patients at low risk for having acute appendicitis. We believe that AppyScoreAPPY1 has the potential to enhance the effectiveness and speed of patient evaluation and improve the standard of care for low risk patients. We anticipatebelieve that if we achieve successful testing and AppyScoreAPPY1 is cleared by the FDA, it couldwill be incorporated with other blood-testing whenin routine testing as a patient’s blood sample is taken onin the ordinary course of an initial assessment of the patient entering the emergency department or urgent care setting when the physician suspects appendicitis, but considers the patient at low risk for the disease. The AppyScore test will comprise a multi-marker blood test panel of biomarkers consisting of the company’s patented MRP 8/14 and CRP, along with incorporating the hospital collected WBC input into the reader which will then provide a result. The AppyScoreAPPY1 result is intended to cost-effectively help the physician determineidentify if a patient is at a low risk for acute appendicitis. We anticipateappendicitis as the potential primary market for the AppyScore testcause of his or her abdominal pain.

AnAPPY1 result will be reported as negative (result below the designated cut-off value) or inconclusive (result at or above the designated cut-off value). A negativeAPPY1 result can be used by physicians, as an adjunct to other signs and symptoms, to identify those patients at low risk for appendicitis, thereby allowing for use of a more conservative treatment plan, i.e., observation and monitoring rather than a surgical consult and/or CT scan, which is more costly, time-consuming and with potential long-term harmful effects. We believeAPPY1 may potentially mitigate unnecessary radiologic imaging in those patients who are identified as being at low risk for acute appendicitis. The use ofAPPY1 in emergency departments could also positively impact resource utilization, and improve patient management and overall emergency department efficiency. The primary focus of our recent product development efforts is directed toward obtaining FDA clearance forAPPY1 for children and adolescents.

The potential value of theAPPY1 test is to identify those patients with negative results, thereby aiding a physician in identifying those patients at low risk for acute appendicitis and allowing for a more conservative


TABLE OF CONTENTS

evaluation and treatment path. We do not expect an inconclusiveAPPY1 result to have an impact on the decision made by the physician to pursue the current treatment path, other than to provide the additional data to be factored into the treatment decision. The followingAPPY1 data, which were presented for appendicitis in 2012 at the National and Regional meetings of the Society for Academic Emergency Medicine (SAEM), summarize the results of a 2011 pilot study we conducted:

APPY1 Multi-Marker Study Result95% Confidence Interval
Sensitivity(1)96.592.1 - 98.5
Specificity(2)43.238.2 - 48.3
NPV(3)96.992.9 - 98.7

(1)The sensitivity of a diagnostic test reflects the probability that a patient with a disease will have a positive test result.
(2)Specificity reflects the probability that a patient without disease will have a negative test result.
(3)Negative predictive value (NPV) reflects the probability that a patient with a negative test result will not have the disease.

These initial study data demonstrated high sensitivity and high NPV similar to other adjunctive tests for other conditions currently in use by physicians. We believe that these performance attributes should provide the emergency medicinedepartment physician with incremental diagnostic market. If successfully developed, testedinformation to enhance their decision-making process. By way of example, with an NPV of 96.9%, the physician could be 96.9% confident that the patient with a negative result did not have appendicitis. The pilot study data also show that 43% of patients who underwent CT scans had a negativeAPPY1 result, and cleared bypotentially could have been treated more conservatively if the FDA,test had been available as part of the treatment plan.

In the spring of 2012, we expect ourconducted a survey of 22 emergency department physicians who face daily the difficult diagnosis pathway for pediatric and adolescent patients presenting with abdominal pain. These physicians indicated that the addition ofAPPY1 with high NPV would enable them to use the test willto assist in the identification of low-risk patients, and decrease their overall use of CT scans in such patient population. Although the use of CT scans appears to be the only commercially available blood-based test specifically designed to aidmost widely used diagnostic tool for acute appendicitis in the evaluationU.S., its results can be inconclusive, and each CT scan subjects the patient to large doses of acute appendicitis for low risk children and young adult patients. We believepotentially harmful radiation. As further described below, over the past decade there is a significant worldwide market opportunity for this product.has been increasing concern regarding the long-term effects of radiation exposure from radiologic tests.

Clinical and

Product Development — Appendicitis

and Prior Clinical Trials and Studies

We began product development of AppyScoreAPPY1 in 2003 with the objective of developing a blood-based, human diagnostic test to aid in the evaluation of patients suspicious forsuspected of having acute appendicitis. In December 2008, we completed aan initial clinical trial (approximately 800 patients) using the original ELISA-based AppyScore APPY1test using MRP 8/14 as a single biomarker test, for use as an aid in the evaluation of acute appendicitis. The results of this study,trial, based upon an MRP 8/14 AppyScore cut offdesignated cut-off value of 15,20 and a study design supplemental alternative cut-off of 14, showed sensitivity of 89%77%, negative predictive valueNPV of 89%81% and specificity of 38%.48%, and sensitivity of 90%, NPV of 87%, and specificity of 33%, respectively. Based on these results, in June 2009 we submitted a 510(k) premarket notification application to the FDA to seek clearance of the AppyScoreAPPY1 ELISA-based test used in this trial. In August 2009, the FDA responded to our submission with a request for additional information. As a result of a number of factors, primarily the need to revise the test’s designated cut-off value, the Companywe withdrew itsour 510(k) submission in mid-2010.

In March 2010, we completed enrollment for an additional clinical trial (859 patients) of our AppyScoresecond generation ELISA-basedAPPY1 test. TheAPPY1 test based upon MRP 8/14 asused in that study was a single biomarker test.test, based on MRP 8/14. The patients enrolled in this clinical trial were seen in the emergency departments of more than a dozen well-known hospitals across the United States. The statistical analysis report for this 2010 trial, based upon an MRP 8/14 designated cut-off value of 14, showed highersimilar sensitivity (96%) and negative predictive valueNPV (92%), but lower specificity (16%) than seen in the 2008 ELISA-based study. The study report also revealed a wider rangetrial.

We performed, in prevalenceconjunction with our consultants and scientific advisors, significant secondary analyses of acute appendicitis between sites than had been anticipated. The overall prevalence of acute appendicitis was similarthe 2010 clinical trial results and data to that seenexplore the observed change in specificity in the previous2010 trial as


TABLE OF CONTENTS

compared to the 2008 trial. These analyses suggested that the apparent differences between the two studies were primarily due to the conditions of transport for samples from the sites to the central laboratory, where the testing was conducted, in the 2010 trial. An increase inAPPY1 test values that occurred in the “pre-measurement” phase between blood draw at the hospital and the testing at the central laboratory, which involved sample handling, time and transportation, resulted in an apparent increased level of false positives and, accordingly, decreased specificity. As a result of these analyses, we determined that we would not file a 510(k) premarket notification with the FDA based on the results of the 2010 clinical trial, however, inter-site variabilityprimarily due to the low specificity observed in the study not meeting the success criteria specified in the study’s statistical analysis plan. Although the analysis of the 2010 clinical trial results was notably larger, withable to identify the likely source of the performance problems, conclusions based on such a wider rangepost hoc analysis would not be deemed to be acceptable performance evidence by the FDA for filing a 510(k). A primary objective of patients enrolled with acute appendicitis observed between sites.originally developing theAPPY1 ELISA-based product was to serve as the predicate for the rapid, single-use cassette version of theAPPY1 assay. We believe that the large inter-site variabilitypoor performance arising from the pre-measurement sample handling should be mitigated by the cassette version ofAPPY1, which will be run on site in the prevalence reported is an indication ofhospital’s clinical laboratory shortly after the clinical challenge of diagnosing acute appendicitis andpatient’s blood has been drawn in the judgment of individual ED physicians in evaluating acute abdominal pain.current pivotal trial.

In late 2011, we completed enrollment and, in early 2012, completed the analysis of the data for athe pilot trialstudy (approximately 500 patients) of our AppyScoreAPPY1 test involvingas discussed above. This pilot study, which was based on the currentAPPY1multi-marker panel, involved pediatric and adolescent patients aged 2 throughto 20 with symptoms suspicious for acute appendicitis who were enrolled from 11 hospital sites across the country. The pilot study evaluated the use of multiple biomarkers of the AppyScore test configuration and demonstrated appreciably better results than the single-marker test evaluated in previous studies. Based upon data obtained from samples at AspenBio,from the pilot study, we ranmeasured MRP 8/14 values using both our cassette-based reader system as well as the ELISA-based test. WeAs part of our development validation and research process, we also measured values for a number of other biomarkers using internal assays. As part of the patient enrollment and sample collection, we also obtained numerous subjective and objective data points for each subject. This included the patient’s WBC count as processed by the hospital. Our extensive analysisIn this pilot study group, after performance of the data, focusinginitial physical assessment by emergency department personnel, approximately 100 patients were either discharged or immediately transferred to surgery. The remaining 397 patients with abdominal pain suspicious for acute appendicitis were analyzed withAPPY1 and also were subjected to imaging procedures as follows: 309 patients underwent ultrasound, 185 patients went to CT scan including 97 patients whose results were indeterminate on ultrasound. Retrospective analysis shows that 43% of the usepatients who underwent CT scans and interaction46% of combinations of multiple biomarkers, analyzed using a proprietary algorithmthe patients who underwent ultrasound were negative (at low risk) for appendicitis by the AppyScore test configuration, demonstrated appreciably better results than the single-marker test evaluated in previous studies.APPY1 test. The results of this pilot study based on the multi-marker panel, showed negative predictive valueNPV of 97%, sensitivity of 96%, and specificity of 43%. Prevalence of the disease in the pilot study was 29%.

37


TABLE OF CONTENTS

Based on these results, we are advancing the AppyScore product configuration in a new device that uses the MRP 8/14 and CRP biomarkers, along with WBC and a proprietary algorithm. MRP 8/14 and CRP testing will be performed on AspenBio’s cassette-based system, with WBC performed by the hospital’s hematology system or potentially, a standalone system. Each of the individual biomarker’s and the white blood cell count results will be combined and analyzed using the Company’s proprietary algorithm software embedded in the AppyScore cassette reader system. An additional patent application has been filed based on the results of our work involving a number of markers including those mentioned above. Completion of the product development required for the test panel will primarily involve incorporating the CRP test into the current cassette based reader system. The AspenBio development team has completed the initial work required to add CRP to the assay test cassette. Based on a preliminary assessment of the ongoing activities,Following completion of the development work is expected late in2010 clinical trial and the second quarter of 2012.

The expected indication for use for2011 pilot study, we focused our AppyScore product is to aid in the identification of patients at low risk for acute appendicitis. A negative AppyScore result can be used by physicians, as an adjunct to signs and symptoms, to allow for more conservative treatment planning.

Major AppyScore clinical andAPPY1 product development milestonesefforts on eliminating potential performance issues, such as those caused by the transport of specimens, determined to be accomplished are:

Finishconduct future clinical trials using the conversioncassette version ofAPPY1, and validationevaluated whether the assessment of AppyScore toadditional biomarkers would have a multi-marker or “multivariate” blood-based testpositive effect on improving the AppyScore reader cassette system —NPV, sensitivity and specificity ofAPPY1. The results of these development efforts are the currentAPPY1 product candidate. We are using this is currently near completion;
Submit a pre-IDE information package, includingAPPY1 product candidate in the pivotal clinical trial protocol, risk analysis and statistical analysis plandescribed below.

Current Clinical Trial

In August 2012, we provided a pre-investigational device exemption (pre-IDE) submission to the FDA;

VerifyFDA and had a meeting with the FDA in September 2012, as well as follow-up communications in January 2013. This submission and subsequent meetings documented the planned regulatory path for AppyScore,APPY1, which we believe to be de-Novo 510K,de-novo 510(k), as well as achieveachieved agreement on the statistical analysis plan and protocol for the pivotal clinical trial;trial. This cooperative approach with the FDA led to an enhanced clinical trial protocol and proposed intended use statement forAPPY1. In January 2013, we began enrolling patients into our pivotal clinical trial in the United States.

TheAPPY 1 pivotal clinical trial is similar in design to the 2011 pilot study. However, this clinical trial also includes a secondary endpoint seeking information about physicians’ CT utilization. We included questions posed to physicians about their current imaging intentions and what, hypothetically, their diagnostic pathway might have been if anAPPY1 test result had been available. We believe this additional endpoint will help determine the clinical utility ofAPPY1. The enrollment criteria for patients are aged 2 to 20 with abdominal pain with some suspicion of appendicitis. Patients identified as being at very high risk of appendicitis are

Commence

TABLE OF CONTENTS

excluded from the trial. Immediately following patient enrollment, blood is drawn and immediately transported to the on-site clinical laboratory at the hospital, where the sample is processed by hospital lab technicians, andAPPY1 test is performed on the APPY reader. This specimen workflow differs from that in the 2010 clinical trial and 2011 pilot study where samples were packaged and shipped to us for analysis. In addition to the in-house sample testing, hospital personnel will collect additional clinical information for each patient enrolled in the pivotal clinical trial, plannedincluding initial clinical impressions and the results of any imaging ordered on the patient. This information is captured on a clinical data sheet and transported to an independent data management company, and the results are entered in a master database. Final patient diagnosis (confirmed acute appendicitis or negative for mid-2012; and

Completeappendicitis) is also entered into the pivotal clinicaldatabase. All information, includingAPPY1 results, is blinded to Venaxis as well as the principal investigators. Based on our statistical analysis plan, we intend to enroll 2000 evaluable patients in the trial from 28 U.S. based hospitals. We intend to complete patient enrollment — planned for late 2012 into earlyand complete data entry in the fourth quarter of 2013, analyze data, and submit pivotal clinical trial results to FDA.

Assumingmake a successful clinical testing outcome of the planned clinical pivotal trial this, data would serve as the basis for a 510(k) submission to the FDA as soon as practical after such completion.

Commercialization and Marketing

In late 2012, we completed the steps required for a conformity mark under the European Economic Area (CE marking) for theAPPY1 product. We were notified in January 2013 that we had obtained CE marking in Europe forAPPY1. We are advancing on a path whichcommercialization and marketing activities ofAPPY1 in the European Union, employing the clinical data gathered to date. During the initial launch phase, we expect key market development activities will include working to include De Novo product classification.

AppyScore Intellectual Property

Beginning in 2004, we initiated the establishment of an intellectual property portfolioidentify and sign collaboration agreements with key opinion leader hospitals for the acute appendicitis testing technologypurpose of completing well-defined outcome studies over the coming months. The studies are designed to further demonstrate the clinical utility and products that have been usedeconomic value ofAPPY1 in Europe. They are expected to help us determine the developmentproduct’s precise marketing approach as we move into the second phase of AppyScore. the EU launch, a full-scale distribution and sales effort forAPPY1, which is anticipated later in 2013.

We have filed forentered into commercial development agreements with a number of diagnostic test distributors in Italy, Turkey and the Benelux countries, and are pursuing extensive patent coverage relatedcommercial development agreements with such distributors in the U.K., France and Germany. Under these commercial development agreements, we are working to several aspectsroll out our market development program forAPPY1, including identification of initial hospitals and key opinion leaders in the initial discovery and various test applications. Further enhancement and expansionEuropean territories in which we are focused. Our strategy is to leverage the experience of our proprietary patent position is ongoing with respect to the scope of protection for our first generation and future generation versions of the test. Scientific and technical progress remains the basis for these efforts. In March 2009, the U.S. Patent and Trademark Office issued AspenBio’s patent directed to methods relating to its appendicitis diagnostic technology. This patent, No. 7,501,256, is entitled ‘Methods and Devices for Diagnosis of Appendicitis.’ Additional U.S. patents, 7,659,087 and 7,670,769, have recently issued on February 9, 2010 and March 2, 2010, respectively. One foreign patent has also been allowed, Japanese patent, 4,447,641 was allowed on January 29, 2010. At this time, additional foreign patent applications have been allowed or are pending.

In late 2011, an additional provisional patent application was filed for the appendicitis testing technology and products. This patent filing focuses on the newly developed multiple-marker technology, providing patent coverage for using the MRP 8/14 levelskey opinion leaders in a given sample in conjunction with CRP levels and WBC among a number of other markersselect hospitals in order to provide an increasingly robustgenerate additional meaningful, multinational field data forAPPY1 products. We have received initial stocking orders for ourAPPY1 products under these relationships.

TheAPPY1 test is expected to be sold into the emergency medicine diagnostic market. If cleared by the FDA for sales in the U.S., we expect the test will be the only commercially available blood test specifically designed to aid in the managementevaluation of low risk patients suspiciousacute appendicitis for appendicitis. Additionally, this patent filing claims a method for ruling out appendicitis based on multiple markers, a device or system for assessing a subject based on a plurality of markers,children and a kit or device to determine the value of a biomarker in a given sample. Currently, this filingyoung adult patients. We therefore believe there is a provisional patentsignificant worldwide market opportunity for this product.

Raw Materials and not yet filed or grantedSuppliers

OurAPPY1 products include an APPY reader instrument and the consumable test products consisting of test cassettes, controls and packaging. The APPY reader is manufactured for us by a well-established vendor based in any specificGermany. Currently, all readers are shipped to our facility in Castle Rock, Colorado for final testing and release prior to shipment to customers and clinical trial sites. Consumable test product components are manufactured at our facility. Raw materials and certain sub-components are acquired from a number of suppliers. All significant vendors are qualified based upon a quality review, which may also include on-site quality audits.

Distribution Methods

Having recently obtained CE marking, we are advancing commercial and marketing activities in the EU. The initial target countries for our commercialization focus are the U.K., Italy, France, Germany, Turkey and the Benelux countries. We have entered into commercial development agreements with diagnostic test distributors in these countries and have identified initial hospitals to target. Our strategy is to leverage the experience of key opinion leaders from these hospital sites in order to generate additional meaningful, multinational field data forAPPY1.


38


 

TABLE OF CONTENTS

Following FDA clearance ofAPPY1, direct sales activities would commence in the U.S. At this time, there are no plans to use third party distributors in the U.S. Customer fulfillment of purchase orders are anticipated to be made via direct shipments from our facility to the customer. Sales and marketing support is expected to be via a limited direct sales force and a customer web portal.

Animal Healthcare

Our animal health technology, licensed fromEffective May 1, 2004, we entered into an Exclusive License Agreement (WU License Agreement) with Washington University in St. Louis (WU) in 2004 and further developed at AspenBio, is the basis of our product development efforts focused on reproduction drugs, initially for cattle, to be followed by other livestock species of economic importance. The cattle products were sub-licensed in 2008 to Novartis Animal Health (NAH or Novartis) under a long-term world-wide development and marketing agreement. Between 2008 and 2011, substantial investment and progress in product, regulatory and clinical activities were made on the bovine drug products, including advances in cGMP manufacturing processes with a contract manufacturer and safety studies required under FDA regulations. A pilot study was completed during late 2010 using the cattle LH drug and subsequently NAH informed, which granted us that preliminary pilot study results revealed that the pilot study did not demonstrate the outcomes as defined in the success criteria. NAH requested a refund of the contingent $900,000 milestone payment that was tied to the pilot study outcome and notified us that they wished to terminate the agreements. On November 15, 2011, AspenBio and Novartis executed a Termination and Settlement Agreement (“Agreement”) that provided for the termination of the existing agreements between the Company and NAH. Under the terms of the Agreement, the Company will pay to NAH the refundable $900,000 milestone payment and a negotiated amount totaling $475,000 of the Company’s portion of net shared development expenses. The settlement amount is payable in quarterly installments commencing upon execution of the Agreement and for the following six fiscal quarters. Upon execution of the Agreement, the Company gained access to and use of all development and research materials and protocols developed under the prior NAH agreements. All of NAH’s rights under the prior agreements will be terminated in full once the Company pays the settlement amount in full.

The Exclusive License Agreement (WU License Agreement) between AspenBio and WU was entered into effective May 1, 2004, and grants AspenBio exclusive license and rightsright to sublicense WU’s technology (as defined under the WU License Agreement) for veterinary products worldwide, except where such products are prohibited under U.S. laws for export. The term of the WU License Agreement continues until the expiration of the last of WU’s patents (as defined in the WU License Agreement) to expire. AspenBio has. We have agreed to pay minimum annual royalties of $20,000 annually during the term of the WU License Agreement and such amounts are creditable against future royalties.royalties and other payments. Royalties payable to WU under the WU License Agreement for covered product sales by AspenBious, directly or indirectly, carry a mid-single-digitmid-single digit royalty rate and for sublicense fees received by AspenBious carry a low double-digit royalty rate. The WU License Agreement contains customary terms for confidentiality, prosecution and infringement provisions for licensed patents, publication rights, indemnification and insurance coverage. The WU License Agreement is cancelable by AspenBious with ninety90 days advance notice at any time and by WU with sixty60 days advance notice if AspenBiowe materially breachesbreach the WU License Agreement and failsfail to cure such breach.breach in a designated period.

OurIn July 2012, we entered into an Exclusive License Agreement (License Agreement) with a licensee (Licensee), under which we granted the Licensee an exclusive royalty-bearing license to our intellectual property and other assets, including patent rights and know-how, relating to recombinant single chain reproductive hormone technology for use in our animal health assets. The License Agreement includes a sublicense of the technology licensed to us by WU and a license to the assets acquired from Novartis under the Novartis termination agreement described below. Under the terms of the WU License Agreement, a portion of license fees and royalties we receive from sublicensing agreements will be paid to WU.

Under the License Agreement, the Licensee obtained a worldwide exclusive license to develop, seek regulatory approval for and offer to sell, market, distribute, import and export luteinizing hormone (LH) and/or follicle-stimulating hormone (FSH) products for bovine (cattle), equine and swine in the field of the assistance and facilitation of reproduction in bovine, equine and swine animals. We also granted the Licensee an option and right of first refusal to develop additional animal health products consistoutside of four veterinary therapeutic drug products which are anticipated to be an important new addition to veterinary medicine with two drugs each in large livestock markets, cattle and equine. We have also advanced in the preliminary developmentlicensed field of potential recombinant productsuse or any diagnostic pregnancy detection tests for use in commercial pig operations. Cattle products, BoviPure-LHTM and BoviPure-FSHTM are the most advanced productsin the pipeline, having advanced in cGMP manufacturing processes with a contract manufacturer and safety studies required under FDA regulations, and we believe represent the largest market opportunity.non-human mammals.

We are currently advancing in a strategic process to monetize ourThe animal health businesstechnology licensed from WU in 2004 was sub-licensed in 2008 to Novartis Animal Health, Inc. (Novartis) under a long-term world-wide development and related intellectual property. The goal of this process is to entermarketing agreement. In November 2011, we entered into a transaction or licensetermination agreement with a third party who would most likely be a company currentlyNovartis to terminate the Novartis license agreement. Under the Novartis termination agreement, the original termination obligation totaled $1,374,000. The remaining outstanding termination obligation at March 31, 2013 was approximately $201,000, which is due in the industry, who would take over product development, testing, approval and launch.

Assuming we are successful in completing a transaction or a licensing agreement for the animal health business, future product development and any potential product revenues would be expected to be undertaken by a new partner or other third-party. The discussion below represents a summary2013. Upon execution of the products and markets that would beNovartis termination agreement, we recorded a gain of $938,896, arising from the subjectelimination of such third party rights, assuming a third-party agreement is in fact entered into and finalizedboth the then remaining deferred revenue and the products are thereafter advancednet accounts payable to commercialization.

39


TABLE OF CONTENTS

Recombinant LH and FSH Analog Drugs for Animal Reproduction Technology

Cattle Reproduction Products

We believe thatNovartis, the cattle market, primarily dairy operations, represents the largest market opportunity of our current animal products in development.

The success of a modern dairy cow operation is dependent upon a number of critical factors. Several of these factors are outside the control of the dairy producer, such as milk prices, costs for feed, nutrients, and medicines. Other factors, however, are within the dairyman’s control such as size of the operation (number of head milked), labor costs, and access to high quality bulk feed. The amount of revenue derived from milk sales is a function of the quantity of milk produced and the level of milk fat contained in the milk. These factors correspond directly to the amount of time that a cow is pregnant. The more days during a year that a cow is not pregnant (frequently referred to as “open”), the lower the annual milk production from that cow, accordingly the lower the revenue received.

The worldwide population of dairy cows is estimated to exceed 125 million,total of which approximately 35 million cows are located in North America, South America and Europe. Accordingexceeded the net total settlement obligation to industry estimates approximately 70% of cows in the North American and European dairy industry are artificially inseminated (AI). The average number of days per year that a cow remains open has steadily increased over a number of years. This has had a negative impact on the average milk revenue produced per head. A significant percentage of dairy cows, when artificially inseminated, do not become pregnant. There is a growing percentage, estimated currently at over 70% of artificially inseminated cows that do not become pregnant or they abort or absorb prior to delivery. Lower pregnancy rates are associated with higher milk production costs.Novartis.

Dairy cows that fail to conceive or maintain a viable pregnancy after AI result in significant financial and production losses to the dairy. BoviPure-LH utilizes our exclusively licensed developmental drug technology which, if successfully developed and approved, we believe may offer performance advantages over conventional hormone products currently available in the worldwide market. If successfully developed and approved, we believe this drug may create a totally new pregnancy maintenance market to enhance dairy economics for artificially inseminated dairy cows.

BoviPure-LH

BoviPure-LH is a novel LH analog for cows. This new hormone analog is designed to induce ovulation and produce an effect that has been shown to reduce the rate of pregnancy loss in cows. Currently, it is estimated that more than 70% of dairy cows fail to conceive and/or maintain a viable pregnancy resulting in significant financial and production losses to dairy farmers.

It is estimated that there are between 16 and 20 million artificial insemination attempts annually in dairy cows in the United States alone. We believe the U.S. fertility control market for BoviPure-LH could be substantial. While pivotal studies are required to definitively demonstrate its specific properties and advantages, we believe BoviPure-LH would be an applicable and beneficial product, if approved by the FDA and administered to dairy cows as part of an artificial insemination program as a therapeutic treatment to improve the quality of ovulation and help maintain pregnancy. It is anticipated that if this product receives regulatory approval it would be prescribed and administered by licensed veterinarians; we expect the ultimate customers will be producer clients operating commercial dairy herds using breeding programs.

We anticipate the benefits and value of the BoviPure-LH product, if able to be successfully tested, approved and launched into the dairy industry, are summarized as follows:

pregnancy rates may increase and potentially reduce the additional cost and manipulation to the animal of repeated reproduction treatments;
potentially reduce average days a cow is “open,” thereby improving overall milk production, milk quality and calf production;
anticipated cost per application may be cost-justified to the dairy operator;
the product is expected to be easy to administer; and
technology is patented with additional patents pending.

40


TABLE OF CONTENTS

BoviPure-FSH

BoviPure-FSH is a novel FSH analog for cows. It is designed for superovulation for embryo transfer in dairy and beef cows throughout the world. We expect the initial usage will be greatest in the beef industry but is expected to expand in the dairy industry with the anticipated increased use of predetermined sex semen for artificial insemination. This product is in development and is expected to provide significant benefits including superior single-dose product efficacy, unmatched purity, consistent bioactivity and significant labor savings for end users, versus conventional “animal-derived” pituitary extract FSH products currently on the market. These benefits are important to users of FSH products currently on the market. Conventional FSH products, all of which are directly harvested from animal organs, have inherent problems with product safety, purity and consistency. In addition, these conventional FSH products require considerable human and facility resources with an average of eight treatments given every 12 hours for four consecutive days for every animal being treated versus our single treatment product.

Equine Reproduction Products

The equine (horse) breeding industry currently lacks effective methods that can effectively impact and control follicular development. Extracts containing pituitary-derived LH and FSH have been shown to be somewhat effective; however, there is currently no commercially available product. The use of artificial lights to simulate longer days is also regularly used to attempt to advance the breeding season.

We have advanced preliminary development and testing of equine products EquiPure-LHTM (LH analog for horses) and EquiPure-FSHTM (FSH analog for horses) to the stage of testing non-GMP manufactured drug product in horses. These specialized products are designed to create more effective breeding programs for horses. The ability to influence the timing of when mares are ready to breed, including potentially accelerating the seasonal ovulation, improving the success rate of bred mares and in some cases, increasing the number of embryos produced and harvested for transfer, are all valuable in equine reproduction worldwide. We have collaborated with researchers at several universities over several years to study these products and produce a number of publications regarding the basic science of these analogs. As part of our equine product development considerations, we are exploring options for securing funding for such product development as a separate funding opportunity.

EquiPure-FSH

EquiPure-FSH is a novel FSH analog for horses. It is designed to assist mares through transition and for super-ovulation (for embryo transfer) in horses throughout the world. Based upon a Kentucky state legislative report, the U.S. thoroughbred horse industry spends over $1.5 billion annually for breeding for new foals.

The most significant breeding issue in mares is the timing conflict existing between horse breeders’ goals versus the animal’s normal breeding cycle during the year. The natural breeding season in horses in the Northern Hemisphere is from April to October. There are several beneficial reasons to try to influence the normal pattern of reproduction. In racing and some performance horses the age of the horse in the Northern Hemisphere, is always measured as of January 1st in the year of birth, therefore it is important that foals are born as early as possible in the year so that they have more time to develop their mature body weight (and strength) by the time they compete as two and three year olds. The demands of competition and sales, breeders and investor owners desire early breeding in the calendar year. This objective requires effective breeding programs. Current programs include extending the mare’s daily photoperiod by artificial lighting in an attempt to advance reproductive activity. This process requires approximately 1 – 2 months and is costly (labor, feed, electricity) and requires additional infrastructure on the farm. There are currently no effective therapeutic drugs available to address this problem. EquiPure-FSH is designed to, and in preliminary studies, has been shown to provide an effective solution to current alternative methods to influence the natural breeding season.

Thoroughbred horses would comprise an important worldwide segment of the EquiPure-FSH market, if the product receives regulatory approval. According to 2009 Jockey Club statistics, there were an estimated 45,000 mares bred in the United States and 180,000 worldwide. Additionally the embryo transfer (ET) market is significant. The 2009 International Embryo Transfer Society worldwide data lists approximately 60,000 donor and recipient mares combined used in ET activities. Argentina and Brazil dominate the

41


TABLE OF CONTENTS

ET industry with an estimated total of two-thirds of the worldwide transfers occurring in those countries. A significant portion of that activity relates to the polo horse industry.

EquiPure-LH

EquiPure-LH is a novel LH analog for horses. It is designed to induce ovulation in estrous mares thereby providing better overall breeding management and convenience to breeders. It is expected that this product will be prescribed and administered by licensed veterinarians when and if it is cleared for use by the FDA. Ultimate customers would be horse owners and breeding farm operations. EquiPure-LH is in the early stage of product development and testing.

Human Diagnostic Antigens

Historically weWe formerly supplied purified proteins for diagnostic applications to large medical diagnostic companies and research institutions. Our human antigens products were purified from human tissue or fluids. We manufactured and sold approximately 20 – 30 purified protein products primarily for use as controls by diagnostic test kit manufacturers and research facilities, to determine whether diagnostic test kits are functioning properly. As a result of the developmentfocusing our activities and priorities, we are focused on theAPPY1 blood-based human diagnostic test, and in the first quarter of 2011, we substantially terminated operations of the antigen business.business in the first quarter of 2011. In 2012 and 2011, we had approximately $42,000 and $219,000, respectively, in revenue from these products and expect such revenues to decline significantly in 2012 and thereafter.

Raw Materials

Our human antigens products were purified from human tissue or fluids. In 2010, due to the fact that the Company is focusing its efforts primarily on the development of other products, primarily its AppyScore test, purchaseswind-down sales of these raw materials were suspended.products.


TABLE OF CONTENTS

Intellectual Property

APPY1 Intellectual Property

Further enhancement and expansionBeginning in 2004, we initiated the establishment of our proprietary patent position is ongoing with respect to the scope of protection for the Company’s first generation and future generation versions of tests. Strong scientific and technical progress remains the basis for these innovative efforts.

Human Diagnostics

AspenBio Pharma, Inc. began building itsan intellectual property portfolio for the acute appendicitis testing technology and products that have been used in 2004.the development ofAPPY1. We have filed for and are pursuing worldwideextensive patent coverage related to several aspects of the initial discovery and various test applications. This initial patent family, entitled “Methods and Devices for Diagnosis of Appendicitis”, has a number of granted patents, as well as several others still in prosecution worldwide. Further enhancement and expansion of our proprietary patent position isintellectual property positions are ongoing with respect to the scope of protection for our first generation and future generation versions of theAPPY1 test. Recently, key scientific advancementsScientific and technical progress remains the basis for these efforts. In March 2009, the USPTO issued our patent directed to methods relating to our MRP 8/14-related appendicitis diagnostic technology. This patent, No. 7,501,256, expiring February 7, 2026, is entitled ‘Methods and Devices for Diagnosis of Appendicitis’. Additional U.S. patents, 7,659,087 and 7,670,789, were issued on February 9, 2010 and March 2, 2010, respectively, and both expire on July 25, 2025. At this time, patents have led to the filing of a second patent family, entitled “Compositions and Methods for Assessing Appendicitis”, which focuses on a multi-marker approach to aidbeen issued in the diagnosis of appendicitis.following foreign countries: Australia, Hong Kong, Israel, Japan, New Zealand, Singapore, and South Africa. A patent was also granted by the European Patent Office and subsequently validated in the following European countries: Belgium, Switzerland, Germany, Spain, France, The United Kingdom, Ireland, Italy, the Netherlands and Sweden. Additionally, there are several patent applications currently in prosecution in several foreign countries.

In November 2011 an additionallate 2012, a U.S. utility application and a PCT patent family filing was added to AspenBio’s intellectual property portfolioapplication were filed for the appendicitis testing technology and products. Thisproducts, following a provisional patent filing focusesapplication filed in November 2011. The patent filings focus on the newly developed multiple-marker technology, providing patent coverage for using the level of MRP 8/MRP8/14 levels in a given sample in conjunction with CRP levels and WBC among a number of other evaluated marker combinations in order to provide an increasingly robusta test to aid in the diagnosismanagement of low risk patients suspicious for appendicitis. Additionally, thisthe patent filing claimsapplications claim a method for ruling out appendicitis for a patient in a low risk group based on multiple markers, a device or system for assessing a subject based on a plurality of markers,patient, and a kit or device for assessing appendicitis in a patient to determine the value of a biomarker in a given sample. Currently, this second patent family filing is a provisional patentthese filings are in application phase and has not yet been filed or granted in any specific countries.

42


TABLE OF CONTENTS

In May 2003, AspenBiowe entered into an Assignment and Consultation Agreement (the Bealer Agreement) with Dr. John Bealer related to the appendicitis diagnosis technology.Bealer. The Bealer Agreement transferred to AspenBious ownership rights from Dr. Bealer for inventions and related improvements to technology associated with human appendicitis diagnostics involving protein antigens. The consideration for the Bealer Agreement was the payment of a future royalty to Dr. Bealer based upon a low double digit rate applied to revenues, all as defined under the Bealer Agreement. The Bealer Agreement contains confidentiality provisions, provides for the assignment of all patent rights to AspenBious (which has occurred) and restrictions on the assignability of the agreement. The Bealer Agreement continues for the longer of twenty20 years or the expiration of the last AspenBio patent to expire. AspenBioof our applicable patents. We may terminate the Bealer Agreement if AspenBiowe in itsour reasonable judgment decides it hasdecide we have no interest in pursuing the opportunity as defined under the agreement.

Animal Health

The AspenBioOur animal health patent portfolio originated under the exclusive license agreement with Washington University (St. Louis, MO),WU, under which we obtained intellectual property rights to their patent estate.estate outlined in the agreement. This extensive portfolio consists of both patents and pending patent applications (approximately 25 patents and numerous patent applications) related to our animal health products under development. The term of the WU License Agreementlicense agreement ends upon the expiration of the last patent to expire. Patents in the estate begin to expire in 2014,2013, with the last of the current patents set to expire afterin 2028. WU has filed, and continues to file, patent applications to expand and extend the patent coverage of the WU technology. AspenBio reimbursesWe reimburse WU for the costs of such patent filings, namely prosecution and maintenance fees. Additional patents in the AspenBio Pharma animal health portfolio have been filed by AspenBio since the executionus outside of the agreement with WU. In addition to the WU patents rights, there are additional patents and patent applications filed by AspenBio.

A patent filing for the recombinant luteinizing hormone (rLH) technology was submitted in 2004, entitled “Methods and Kits for Maintaining Pregnancy, Treating Follicular Cysts, and Synchronizing Ovulation Using Luteinizing Hormone.” This patent family claims methods of administering rLH, the timing of administration, and dosage given in order to increase formation of accessory corpora lutea and maintain pregnancies in treated animals. The patent family includes filings in the following countries (patent number included where applicable): Australia (Pat No. 2004218365), Brazil, Canada and the United States. ThreeTo date, three foreign patents have been granted for ‘Methods“Methods and Kits for Maintaining Pregnancy,


TABLE OF CONTENTS

Treating Follicular Cysts, and Synchronizing Ovulation Using Luteinizing Hormone’Hormone”, New Zealand patent 542549 was granted March 12, 2009 (expiring March 2024), Australia 2004218365 was granted May 27, 2010 (expiring March 2024) and European patent 1610803 was granted December 15, 2010 (expiring March 2024). The patent granted by the European Patent Office and has been validated in the following countries: Belgium, France, Germany, Ireland, Italy, The Netherlands, Spain, Switzerland, and the United Kingdom. Currently, there are additional foreign patent applications that are in prosecution.

A patent filing for the recombinant bovine follicle stimulating hormone (rbFSH) technology was submitted in 2008, entitled “Compositions and Methods Including Expression and Bioactivity of Bovine Follicle Stimulating Hormone.” This patent family claims the rbFSH single-chains itself, as well as methods of administering rbFSH, the timing of administration, and dosage given in order to increase reproduction, induce superovulation or increase embryo production in ungulates. The patent family includes filings in the following countries: Argentina, Australia, Canada, New Zealand, Thailand, and the United States. The patent has also been filed with the European Patent Office. In October of 2011, the first patent in this family was granted by the European Patent Office (2134165). The patent has also been granted in New Zealand (579740). Following the grant of the patent in 2011 by the European Patent Office, the patent was validated in the following countries: France, Germany, Italy, and The Netherlands.

A patent filing for the equine follicle stimulating hormone technology (eFSH) was filed in 2008, entitled “Activity of Recombinant Equine Follicle Stimulating Hormone.”This patent family provides coverage for the single chain eFSH itself, methods of administering reFSH, the timing of administration, and dosage given in order to increase reproductive activity in treated animals. To date, no patents have been issued in thisone patent family. The application has been filedallowed in the patent family in China, and is activeset to grant in the following countries: Brazil, Canada, China, The European Patent Office, and the United States.second quarter of 2013. Currently, additional foreign patent applications are in prosecution.

Two separate patent applications relating to cattle pregnancy have been filed by AspenBio.us. A patent filing for the Bovine Pregnancy test technology was filed in 2007, entitled “Bovine Pregnancy Test.” This patent family provides coverage for an assay device designed to detect pregnancy, the specific specifications of the device, for the antibodies used in the assay, as well as the type of sample used and the species for which the test is effective in detecting pregnancy. The parent application was granted in the United States in 2008 (Pat(U.S. Patent No. 7,393,696), with the and expires on May 30, 2025. The divisional application was granted in 2010 (Pat(U.S. Patent No. 7,687,281). and expires on May 6, 2023. Additionally, a patent filing for pregnancy detection was filed in 2003, entitled “Pregnancy Detection.” This patent family provides coverage for an immunoassay test device, the specific specifications of the device, and for the antibodies used in the assay as well as the type of sample used. The patent has been issued in the following counties: Australia (Pat No.(No. 2003243199), New Zealand (Pat No.(No. 536229 & 572488), and the United States (Pat No.(No. 7,842,513)., each of which expires on May 2, 2023.

43


TABLE OF CONTENTS

General Operations

Backlog and Inventory — Historically, our antigen business has not been seasonal in nature. As a result of our activities being focused on AppyScoreAPPY1 product development, we do not currently expend large amounts of capital to maintain a human antigen inventory. We believe we have developed and identified reliable sources of raw material and components as we progress towards commercialization of the AppyScoreAPPY1 test.

Payment termsTerms — Historically in connection with our human antigen business we did not provide extended payment terms, other than to support certain new product introductions, and then with terms of no more than 60 days.

Revenues — Historically the majority of our revenues have come from U.S. customers of our human antigen business with no long-term supply agreements and orders processed on a purchase-order basis. For the three months ended March 31, 2012, four customers represented the total sales for the period. TwoThree customers accounted for $93,000$34,000 of the total 20112012 sales and individually represented 28%40%, 30% and 14%13% of such sales. During the yearsyear ended December 31, 2011, 2010 and 2009, one2012, two European-based company,customers accounted for a total of 3%, 4% and 3%, respectively, of our net sales. Our U.S. based revenues for the three months ended March 31, 2012 was $7,000sales, and for the years ended December 31, 2011 and 2010, one European-based customer accounted for a total of 3% and 2009 were $213,000, $355,000 and $282,000, respectively.4%, respectively, of our net sales. Other than as described above, for all periods presented, our revenues have been generated in the U.S.


TABLE OF CONTENTS

Research and Development

ResearchWe expended approximately $1,412,000 on total research and development expenses in the three months ended March 31, 2013, $3,838,000 in the year ended December 31, 2012, totaled $677,000. We expended $5,666,000 on total researchin year ended December 31, 2011 and development in fiscal 2011, $6,112,000 in fiscal 2010 and $9,292,000 in fiscal 2009.the year ended December 31, 2010. We anticipate that total expenditures for research and development for the fiscal year ending December 31, 20122013 will generally decreaseincrease as compared to the amounts expended in 2011,2012, due primarily to the completionconduct of a majority oftheAPPY1 clinical trial in the AppyScore discovery efforts in 2011, combined withU.S. during 2013 that is expected to enroll approximately 2,000 patients. These costs will be somewhat offset by lower expected product development activitiesexpenses in 2012, offset by additional anticipated clinical trial costs in the second half of 2012.2013. Research and development activities for the animal health business are expected to be minimalcovered by the licensee in 2012.2013.

Development and testing costs in support of the current products, as well as costs to file patents and revise and update previous filings on our technologies, will continue to be substantial. Our principal development product consists of the acute appendicitis test, AppyScore.APPY1. Development and clinical test costs in support ofAPPY1, as well as costs to file and prosecute patents and patent applications related to our technologies, will continue to be substantial. As we continue towards commercialization of these productsthis product, including evaluation of strategic alternatives to effectively maximize the value of our technology, we will need to consider a number of alternatives, including possible capital raising or other transactions and partnering opportunities, working capital requirements including possible product management and distribution alternatives and implications of product manufacturing and associated carrying costs. Certain costs such as manufacturing and license/royaltyDifferent agreements will have different implications depending upon the ultimate strategic path determined.cost implications.

In April 2008, we entered into a long term exclusive license and commercialization agreement with Novartis Animal Health, Inc., to develop and launch our novel recombinant single-chain bovine products, BoviPure LH and BoviPure FSH. The license agreement was a collaborative arrangement that provided for a sharing of product development activities, development and registration costs and worldwide product sales for the bovine species. We received an upfront cash payment of $2,000,000 under the Novartis License Agreement, of which 50% was non-refundable upon signing the agreement, and the balance subject to certain conditions. In 2010, the conditions associated with $100,000 of such milestones were satisfied. Novartis had the right to request a refund of the $900,000 remaining milestone payment and/or terminate the agreement if the pilot study (as defined in the agreement) was not successful. NAH informed us that preliminary pilot study results revealed that the pilot study did not demonstrate the outcomes as defined in the success criteria, and NAH requested a refund of the contingent $900,000 milestone payment that was tied to the pilot study outcome and notified us that they wished to terminate the agreement. On November 15, 2011, AspenBio and Novartis executed a Termination and Settlement Agreement that provided for the termination of the existing agreements between the Company and NAH. During the three months ended March 31, 2012 we expended approximately $4,000 and during the years ended December 31, 2011, 2010 and 2009, we expended approximately $148,000, $1,154,000 and $1,109,000, respectively, in direct costs for the BoviPure LH and BoviPure FSH product development and related efforts.

44


TABLE OF CONTENTS

We have entered and expect to continue to enter, into additional agreements with contract manufacturers for the development/development and manufacture of certain of our products and system components for which we are seeking or plan to seek FDA clearance. The ultimate goal of this development process is to establishconfirming current good manufacturing practices (cGMP) manufacturing methodscompliance required for those products for which we are seeking FDA clearance. We enter into discussions from time to time with various potential manufacturers who meet full cGMP requirements and are capable of large-scale manufacturing batches of our medical devices, and who can economically manufacture them to produce our products at an acceptable cost. These development and manufacturing agreements generally contain transfer fees and possible penalty and/or royalty provisions shouldif we transfer our products to another contract manufacturer. We expect to continue to evaluate, negotiate and execute additional development and manufacturing agreements, some of which may be significant commitments during 2012.2013. We may also consider acquisitions of development technologies or products, shouldif opportunities arise that we believe fit our business strategy and would be appropriate from a capital standpoint.

ComplianceRegulatory Matters

FDA

The FDA has regulatory marketing authority in the United States over virtually allourAPPY1 products. Venaxis operates under ISO 9001-4385 standards for cGMP manufacturing of our products in development.medical devices.

AppyScore Acute Appendicitis Blood Tests — The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, re-label and or import medical devices sold in the United States. Medical devices are classified based on risk into Class I, II and III. Lacking a predicate device, currently ourOurAPPY1 acute appendicitis test in development is anticipated to be classified as a non-invasive Class IIIII medical device by the FDA, which will require reclassification under the de-Novode novo Premarket Notification 510(k) pathway. We continue to anticipate being able to obtain FDA 510(k) clearance of our acute appendicitis blood test following successful completion of required clinical trials and other activities.clearance. Generally, FDA product clearance for diagnostic products is granted after specific clinical trials GMP validations and quality control requirements have been achieved to the agency’s satisfaction. There is no assurance that we maywill obtain FDA clearance to market our acute appendicitis test.

Any product clearances or approvals(or approvals) that are granted remain subject to continual FDA review, and newly discovered or developed safety or efficacy data may result in withdrawal of products from the market. Moreover, if and when such approvalclearance is obtained, the manufacture and marketing of such products remain subject to extensive regulatory requirements administered by the FDA and other regulatory bodies, including compliance with current GMP,cGMP, adverse event and medical device reporting requirements and the FDA’s general prohibitions against promoting products for unapproved or ��off-label”“off-label” uses. Manufacturers are subject to ongoing inspection and market surveillance by the FDA for compliance with these regulatory requirements. Failure to comply with the requirements can, among other things, result in warning or untitled letters, product seizures, recalls, fines, injunctions, suspensions or withdrawals of regulatory approvals, operating restrictions and civil or criminal prosecutions. Any such


TABLE OF CONTENTS

enforcement action could have a material adverse effect on our business. Unanticipated changes in existing regulatory requirements or the adoption of new requirements could also have a material adverse effect on our business.

European Regulations

BoviPure LHIn the European Union, in vitro diagnostic (IVD) medical devices are regulated under EU-Directive 98/79/EC (IVD Directive), and BoviPure FSH Drugs — FDA-INADA filerelated provisions. The IVD Directive requirements include the safety and efficacy of the devices. According to the IVD Directive, the EU members presume compliance with these essential requirements in respect of devices which are in conformity with the relevant national standards transposing the harmonized standards of which the reference numbers previously obtained by Novartis for BoviPure LH (LH analog for cows) and BoviPure FSH (FSH analog for cows) have been transferred to AspenBio. INADA’s officially allowpublished in the Official Journal of the European Communities. These harmonized standards include ISO 13485:2003, the quality standard for medical device manufacturers.

IVD medical devices must bear the conductCE marking of studies to develop data for review underconformity when they are placed on the approval processmarket in the European Union. The CE mark is a declaration by the FDA’s Centermanufacturer that the product meets all the appropriate provisions of the relevant legislation implementing the relevant European Directive. As a general rule, the manufacturer must follow the procedure of the EC Declaration of Conformity to obtain this CE marking. Each European country must adopt its own laws, regulations and administrative provisions necessary to comply with the IVD Directive. In January 2013, we obtained CE marking for Veterinary Medicine (CVM)APPY1.

EquiPure LH and FSH Drugs — we are reviewing our position and plans regarding INADA filings for these two drugs and CVM approval.

Environmental Protection

We are subject to various environmental laws pertaining to the disposal of hazardous medical waste. We contract for disposal of our hazardous waste with a licensed disposal facility. We do not expect to incur liabilities related to a failure of compliance with environmental laws; however, we cannot make a definitive prediction. The costs we incur in disposal of hazardous waste have not been significant.

45


TABLE OF CONTENTS

Other Laws

We are also subject to other federal, state and local laws pertaining to matters such as privacy, informed consent, safe working conditions and fire hazard control.

Glossary of Terms

Human Diagnostic Terms:

We define below certain technical terms used in this prospectus.

Algorithm — a set of rules that precisely defines a sequence of operations, in the case of AppyScoreAPPY1 using a mathematical computation in a software program

Biomarker tests — tests that identify and quantify biologic markers associated with disease or medical condition

cGMP — current Good Manufacturing Practice

Complete Blood Count (CBC) — a blood test used to evaluate overall health and detect a wide range of disorders, including anemia, infection and leukemia

CRP — an abbreviation for C-reactive protein. CRP is a protein produced in the liver and found in the blood, the levels of which rise in response to inflammation

De Novo Classification — a mechanism defined by the FDA Modernization Act (Section 513(f)) for classifying new medical devices for which there is no predicate, device, providing the product with a risk-based Class II classification allowing clearance under as a 510(k)

ELISA (Enzyme Linked Immunosorbant Assay) — immunological method used to test a sample for a protein marker

Genomics — the study of the genomes of organisms

GMP\cGMP — Good Manufacturing Practice\Current Good Manufacturing Practice

Immunoassay-based — test that uses antibody-antigen interaction as method of measure

Multi-marker test — a diagnostic or other test that uses multiple protein biomarkers as part of a diagnostic test panel


TABLE OF CONTENTS

Proteomics — the study of an organismsorganism’s complete complimentcomplement of proteins

Recombinant — Novel DNA made by genetic engineering

WBC — an abbreviation for whiteWhite blood cell count. The white blood cells are analyzed from a blood sample collected as part of a standard protocol for patients suspected of having infections who have entered the Emergency Departmentemergency department of a hospital

Animal Health Terms:

Artificially inseminated (AI) — the process in which a female has been bred via use of semen which does not involve the physical live mounting/breeding using a bull

Compounded Deslorelin reagents — synthetic gonadotropin releasing hormone drug

Embryo transfer — transfer of an embryo from one female to another

Follicle stimulating hormone (FSH) — hormone that induces ovarian follicular development

GnRH-derived products — synthetic gonadotropin releasing hormone compounds

Gonadorelin — synthetic gonadotropin releasing hormone compound

Gonadotropins — See LH and FSH

Heterodimeric complex — natural form of gonadotropin comprising a complex of an alpha and beta subunit which can easily become dissociated

Histopathologic — pertaining cell and histological structure in diseased tissue

INADA — an investigational new animal drug application filed with the FDA


46


 

TABLE OF CONTENTS

PROPERTIES

Luteinizing hormone (LH) — hormone that induces ovulation

Prostaglandin — hormone that causes regressionWe maintain our administrative office, laboratory and production operations in a 40,000 square foot building in Castle Rock, Colorado, which was constructed for us in 2003. We presently do not plan any renovation, improvements or development of this property. We may utilize a portion of the corpus luteumcurrently unused space, which amounts to approximately 14,000 square feet, for expansion or to lease at some point in the future. We believe that our facilities are adequate for our near-term needs.

Single-chain analogs — see single-chain gonadotropin

Single-chain gonadotropin — recombinant formsWe own the property subject to a mortgage with an outstanding balance of gonadotropins composedapproximately $2,403,000 at March 31, 2013, payable in monthly installments of approximately $23,500 and bearing interest at an approximate average rate of 7%. The commercial bank portion of the alphamortgage has a balloon payment of approximately $1.6 million payable in July 2013. On May 9, 2013, we entered into the Modification Agreement with the Bank to refinance the outstanding commercial loan. The loan is collateralized by the real property. The Modification Agreement extends the maturity date to April 2018 and beta subunits fused inreduces the interest rate to a single polypeptide

Single-polypeptide-chain-variants — see single-chain gonadotropin

Super ovulation — using hormone treatmentfixed interest rate of 3.95% from a variable rate equal to stimulate1% over The Wall Street Journal Prime Rate (with a female to produce more than one ovaminimum rate of 7%). The loan terms include a payment amortization period of fifteen years, with a balloon maturity at one time

Legal Proceedings

On September 1, 2010, the Company received a complaint, captionedMark Chipman v. AspenBio Pharma, Inc., Case No. 2:10-cv-06537-GW-JC.five years with monthly payments of approximately $11,700. The complaint was filed in the U.S. District Court in the Central District of California by an individual investor. The complaint includes allegations of fraud, negligent misrepresentation, violations of Section 10(b)portion of the Exchange Act and SEC Rule 10b-5, and violations of Sections 25400 and 25500building mortgage guaranteed by the SBA, which is approximately 34% of the California Corporations Code, all related to the Company’s blood-based acute appendicitis test in development known as AppyScore. On the Company’s motion, the action was transferred to the U.S. District Court for the District of Colorado by order dated January 21, 2011. The action has been assigned a District of Colorado Civil Case No. 11-cv-00163-REB-KMT. On September 7, 2011, the plaintiff filed an amended complaint. Based on a review of the amended complaint, the Company believes that the plaintiff’s allegations are without merit, and intends to vigorously defend against these claims. On October 7, 2011, the Company filed a motion to dismiss the amended complaint, and the plaintiff’s response and the Company’s reply thereto were subsequently filed. Currently, the motion is pending, awaiting a decisioncurrent loan total, remains unaffected by the court.Modification Agreement.

LEGAL PROCEEDINGS

On October 1, 2010, the Companywe received a complaint, captionedJohn Wolfe, individually and on behalf of all others similarly situated v. AspenBio Pharma, Inc. (now Venaxis, Inc.) et al., Case No. CV10 7365.7365 (“Wolfe Suit”). This federal securities purported class action was filed in the U.S. District Court in the Central District of California on behalf of all persons, other than the defendants, who purchased our common stock of the Company during the period between February 22, 2007 and July 19, 2010, inclusive. The complaint namesnamed as defendants certain officers and directors of the Company during such period. The complaint includesincluded allegations of violations of Section 10(b) of the Exchange Act and SEC Rule 10b-5 against all defendants, and of Section 20(a) of the Exchange Act against the individual defendants, all related to the Company’sour blood-based acute appendicitis test in development known as AppyScore.development. On the Company’sour motion, this action was also transferred to the U.S. District Court for the District of Colorado by order dated January 21, 2011. The action has beenwas assigned a District of Colorado Civil Case No. 11-cv-00165-REB-KMT.11-cv-0165-REB-KMT. On July 11, 2011, the court appointed a lead plaintiff and approved lead counsel. On August 23, 2011, the lead plaintiff filed an amended putative class action complaint, allegingcomplaint.

On October 7, 2011, we filed a motion to dismiss the same class period. Basedamended complaint. On September 13, 2012, the United States District Court for Colorado granted our motion to dismiss, dismissing the plaintiffs’ claims against all defendants without prejudice. On September 14, 2012, the court entered Final Judgment without prejudice on a reviewbehalf of all defendants and against all plaintiffs in the Wolfe Suit. The Order to dismiss the action found in favor of us and all of the amended complaint,individual defendants. On October 12, 2012, the Companyplaintiffs filed a Notice of Appeal of the Order granting the motion to dismiss and of the Final Judgment in the Wolfe Suit. The plaintiffs filed their opening brief with the Tenth Circuit Court of Appeals on March 1, 2013. We filed our answering brief with the Tenth Circuit Court of Appeals on April 8, 2013. We and the individual defendants believe that the plaintiffs’ allegations are without merit, have vigorously defended against these claims, and intend to vigorously defend against these claims. On October 7, 2011, the Company filed a motioncontinue to dismiss the amended complaint, and the plaintiff’s response and the Company’s reply thereto were subsequently filed. Currently, the motion is pending, awaiting a decision by the court.do so.

On January 4, 2011, a plaintiff filed a complaint in the U.S. District Court for the District of Colorado captionedFrank Trpisovsky v. Pusey, et al,., Civil Action No. 11-cv-00023-PAB-BNB, that purports to be a shareholder derivative action on behalf of the Companyus against thirteen individual current or former officers and directors. The complaint also names the Companyus as a nominal defendant. The plaintiff asserts violations of Section 14(a) of the Exchange Act, SEC Rule 14a-9, breach of fiduciary duty, waste of corporate assets, and unjust enrichment. On motion of the Company and the individual defendants, the U.S. District Court has stayed this derivative action by order dated March 15, 2011,2011. On October 18, 2012, the parties filed a Joint Status Report, reporting on updates in the Wolfe Suit and this action continues to be stayed. The Company believesstating that the plaintiff lacks standing to proceed withstay should remain in place at this actiontime and intends to challengethat a further status report should be submitted after the plaintiff’s standing if and whenappeal in the stay is lifted.Wolfe Suit has been resolved. On October 25, 2012, the magistrate judge issued a recommendation that the case be administratively closed,


47


 

TABLE OF CONTENTS

subject to reopening for good cause. The U.S. District Court on November 14, 2012, accepted the recommendation and ordered this action administratively closed, subject to reopening for good cause.

In the ordinary course of business and in the general industry in which the Company iswe are engaged, it is not atypical to periodically receive a third party communication which may be in the form of a notice, threat, or ‘cease and desist’ letter concerning certain activities. For example, this can occur in the context of the Company’sour pursuit of intellectual property rights. This can also occur in the context of operations such as the using, making, having made, selling, and offering to sell products and services, and in other contexts. The Company intends toWe make a rational assessment of each situation on a case-by-case basis as such may arise. The CompanyWe periodically evaluates itsevaluate our options for trademark positions and considersconsider a full spectrum of alternatives for trademark protection and product branding.

We are not a party to any other legal proceedings, the adverse outcome of which would, in our management’s opinion, have a material adverse effect on our business, financial condition and results of operations.

Employees

We currently employ twenty-three full-time employees and five part-time employees. We believe our relationships with our employees are good.We also regularly use part-time student interns and additional temporary and contract personnel depending upon our research and development needs at any given time.

Properties

We maintain our administrative office, laboratory and production operations in a 40,000 square foot building in Castle Rock, Colorado, which was constructed for us in 2003. We presently do not plan any renovation, improvements, or development of this property. We may utilize a portion of the currently un-used space, which amounts to approximately 14,000 square feet for expansion at some point in the future. The Company believes that its facilities are adequate for its near-term needs.

We own the property subject to a mortgage with an outstanding balance of approximately $2,545,000 at December 31, 2011, payable in monthly installments of approximately $23,500 and bearing interest at an approximate average rate of 7%. In the opinion of management, the Company maintains adequate insurance coverage on the property.


48


 

TABLE OF CONTENTS

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS
ON ACCOUNTING AND FINANCIAL DISCLOSURE

There have been no disagreements between the Company and its independent accountants on any matter of accounting principles or practices, or financial statement disclosure.

QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK

General

We have limited exposure to market risks from instruments that may impact the Balance Sheets, Statements of Operations, and Statements of Cash Flows. Such exposure is due primarily to changing interest rates.

Interest Rates

The primary objective for our investment activities is to preserve principal while maximizing yields without significantly increasing risk. This is accomplished by investing excess cash in highly liquid debt and equity investments of highly rated entities which are classified as trading securities. As of December 31, 2011, approximately 64% of the investment portfolio was in cash equivalents with very short term maturities and therefore not subject to any significant interest rate fluctuations. We have no investments denominated in foreign currencies and therefore our investments are not subject to foreign currency exchange risk.

49


TABLE OF CONTENTS

MANAGEMENT

ExecutiveOur executive officers of the Company are elected by the Board of Directors, and serve for a term of one year and until their successors have been elected and qualified or until their earlier resignation or removal by the Board of Directors. There are no family relationships among any of theour directors and executive officers of the Company.officers. None of the executive officers or directors has been involved in any legal proceedings of the type requiring disclosure by the Company during the past five years. Further, there is no arrangement or understanding between any director and the Companyus pursuant to which he or she was selected as a director. Mr. Lundy, Mr. Pusey, Mr. McGonegal and Mr. Hurd have employment agreements in place with the Companyus with respect to their executive officer positions with the Company.positions.

The following table sets forth names and ages of all of our executive officers and directors of the Company and their respective positions with the Companyus as of the date of this prospectus:

  
Name Age Position
Stephen T. Lundy 5051 Chief Executive Officer, and President and a Director
Gail S. Schoettler 6869 Non-Executive Chair of the Boardand a Director
Susan A. Evans66Director
Daryl J. Faulkner 63Director
Douglas I. Hepler Ph.D.6564 Director
John H. Landon 71Director
Michael R. Merson67Director
Gregory S. Pusey59Vice President and a Director
Mark J. Ratain, M.D.5772 Director
David E. Welch 6566 Director
Stephen A. Williams54Director
Donald R. Hurd61Chief Commercial Officer, Senior Vice President
Jeffrey G. McGonegal 6162 Chief Financial Officer and Secretary
Donald R. Hurd60Senior Vice President and Chief Commercial Officer

Board of Directors

Stephen T. Lundy was appointed to the positions of Chief Executive Officer and President on March 24, 2010. Effective on the same date, he was appointed to the Company’sour Board of Directors. Mr. Lundy has more than 20 years of experience in drug and diagnostic product development and commercialization. He most recently was Chief Executive Officer of MicroPhage from 2008 to 2010. Mr. Lundy was Senior VPVice President of sales and marketing for Vermillion from 2007 to 2008. Mr. Lundy joined Vermillion from GeneOhm (2003 – 2007), a division of Becton, Dickinson and Company Diagnostics, where he served as Vice President of Sales and Marketing. At GeneOhm, Mr. Lundy successfully led the commercial launch of several novel molecular diagnostic assays including the first molecular test for Methicillin resistant Staphylococcus aureus. From 2002 to 2003, Mr. Lundy served as Vice President of Marketing for Esoterix, Inc., which was acquired by Laboratory Corporation of America, and he led the commercial integration and re-branding of the numerous reference labs acquired by Esoterix. Prior to Esoterix, he served as Marketing Director for Molecular Diagnostics and Critical Care Testing at Bayer Diagnostics Corporation. Mr. Lundy graduated from the United States Air Force Academy with a Bachelor of ScienceB.S. degree and was an officer with the United States Air Force from 1983 to 1988. Mr. Lundy’s qualifications for serving on the Board of Directors include over 20 years of experience in drug and diagnostic development companies, including experience leading the commercial launch of diagnostic products and participation in merger and acquisition transactions in the industry.

Gail S. Schoettler has served on the board of AspenBio Pharma, Inc.,our Board since August 2001. She is a member of the audit committeeAudit Committee, the Compensation Committee and the nominatingNominating and governance committee of AspenBio Pharma, Inc.Corporate Governance Committee. In October of 2010, Ms. Schoettler became Non-Executive Chair of the board of AspenBio.Board. She also serves on the board and is a member of the audit committee of Delta Dental of Colorado, a privately heldnon-profit dental benefitsinsurance company. She serves on the boards of The Colorado Trust where she chairsand the investment committee, and several non-profit organizations.Delta Dental Foundation. Former corporate board positions include;include: Masergy Communications, Inc., CancerVax, Inc., PepperBall Technologies, Inc., AirGate PCS, Women’s Bank, Equitable Bancshares of Colorado, the Colorado Public Employees Retirement Association and Fischer Imaging. She has served as a U.S. Ambassador, appointed by President Clinton, and as

50


TABLE OF CONTENTS

Colorado’s Lt. Governor and State Treasurer. In 1998, she narrowly lost her bid for Governor of Colorado. She started two successful banks and helps run her family’s cattle ranch (where she grew up), vineyards, and real estate enterprises. She and her husband own a travel company that focuses on introducing business and community leaders to their counterparts overseas as well as to other countries’ cultures, economies, and history. She earned a BAB.A. in economics from Stanford and MAM.A. and PhDPh.D. degrees in African Historyhistory from the University of California at Santa Barbara. Among her numerous awards is the French Legion of Honor (France’s highest civilian award) from President Jacques Chirac of France. Ms. Schoettler’s qualifications for serving on the


TABLE OF CONTENTS

Susan Evans, Ph.D., FACB was appointed to our Board of Directors include business acumen,in December 2012 and is a member of the Audit Committee. Dr. Evans is the Vice President, Scientific Affairs, of the Beckman Coulter division of Danaher, Inc., a position she has held since 2006. Previously she served as Vice President, Corporate Strategic Planning for Beckman Coulter from January 2010 to July 2011, and as Vice President and General Manager of Agencourt Bioscience, a Beckman Coulter company from December 2006 to January 2010. She has more than 30 years of publicexperience in the diagnostic industry, holding leadership positions in research and development and now general management. She has developed assays for analytes in the areas of endocrinology, fertility, cardiac markers and therapeutic drug monitoring. Dr. Evans has been involved with the American Association of Clinical Chemistry (AACC) since the 1980s, when she served as an officer in the Florida section and continued with local section activities in San Diego and Chicago. Her service to the AACC on the national level includes being elected to the board of directors, as national secretary, and extensive public company board, businessas president in 2003. She chaired the Program Coordinating Commission twice, was one of the founding members of the Industry Division, and financial experience.is vice chair of the 2008 Annual Meeting Organizing Committee. She currently chairs the Van Slyke Foundation Board of Trustees and the Awards Committee of the AACC.

Daryl J. Faulkner was appointed to the Company’sour Board of Directors in the newly created position of Executive Chairman on January 19, 2009 and on February 10, 2009, was appointed to serve as the Company’sour interim Chief Executive Officer. Mr. Faulkner resigned from the positionsposition of interim Chief Executive Officer as of March 24, 2010, upon the hiring of Mr. Lundy, and the position of Chairman in October 2010. He continues to serve as a director and he is a member of our Audit Committee and chair of the company.Nominating and Corporate Governance Committee. Mr. Faulkner has more than 25 yearsyears’ experience in developing and commercializing medical devices, drug and drug delivery systems, life science research tools, and molecular diagnostics. He served for approximately one year as President, CEO and a member of the Board of Directors of Digene Corporation, a NASDAQ-tradedNasdaq-traded company prior to its acquisition in July 2007 by Qiagen (traded on NASDAQ’sNasdaq’s Global Select market). He served as a consultant to Qiagen, and as co-chair of the executive integration steering committee with the CEO of Qiagen from July 2007 to January 2009. Currently, Mr. Faulkner also serves as a member of the Boardboard of Directorsdirectors of GenMark Diagnostics, Inc. (NASDAQ:(Nasdaq:GNMK), an emerging molecular diagnostics company traded on NASDAQ.Nasdaq. Prior to joining Digene, Mr. Faulkner spent eight years with Invitrogen (now NASDAQ:Life Technologies Corp. (Nasdaq:LIFE)) in a number of senior roles, including SVP Europe, SVP IVGN International Operations, and SVP of Strategic Business Units. Before Invitrogen, Mr. Faulkner’s career includes 15 years with the Fortune 100 Company, Abbott Laboratories, in which he held leadership positions in manufacturing operations and plant management. Mr. Faulkner received a degree in Industrial Relationsindustrial relations from the University of North Carolina and a M.A. in Business Managementbusiness management from Webster University. Mr. Faulkner’s qualifications for serving on the Board of Directors include significant chief executive and senior executive experience in medical device and medical diagnostics publicly traded companies, both national and global.

Douglas I. Hepler, Ph.D. joined the Company’s Board of Directors in March of 2004. Dr. Helper is the chair of the compensation committee of AspenBio Pharma, Inc. Commencing in 2006, Dr. Hepler became President of KADO Consulting a then newly formed consulting firm. Through April 2006, he served as Vice President of Research and Development for IDEXX Pharmaceuticals, Inc., a wholly owned subsidiary of IDEXX Laboratories, Inc. Dr. Hepler was responsible for the overall technical leadership of the Pharmaceutical Division of IDEXX Pharmaceuticals, Inc. Dr. Hepler was also the Co-founder and Executive Vice President of Blue Ridge Pharmaceuticals, Inc. before its sale to IDEXX Laboratories, Inc. in 1998. While at Blue Ridge Pharmaceuticals, Dr. Hepler was instrumental in the development and FDA registration of Acarexx, Iverhart Plus, PZI Vet, Facilitator, Navigator, Pyrantel and CyFly. Prior to Blue Ridge Pharmaceuticals, Dr. Hepler played a pivotal role in the development and FDA registration of Interceptor, Program, and Sentenial while at Novartis Animal Health. Dr. Hepler received a B.S. degree from Lock Haven University in biology, a M.S. from Colorado State University in microbiology and a Ph.D. from Colorado State University in immunology. Mr. Hepler’s qualifications for serving on the Board of Directors include pharmaceutical and regulatory experience at the executive level in the field of animal health.

John H. Landon was appointed to our Board of Directors in December 20082008. He is chair of the Compensation Committee and is a member of the compensationNominating and nominating and corporate governance committees for AspenBio Pharma, Inc.Corporate Governance Committee. Mr. Landon’s career includes more than 30 years of broad, multi-functional experience with the DuPont Company.Company until his retirement in 1996. Prior to retiring from active management, Mr. Landon served as Vice President and General Manager of medical products for DuPont.DuPont from 1992 to 1996. He had worldwide responsibility for all of DuPont’s medical product businesses, encompassing total annual sales of $1 billion and more than 5,000 employees. In addition to other director roles, Mr. Landon served as Chairman of the board of Cholestech Corporation prior to its 2007 sale to Inverness Medical and as a director of Digene Corporation prior to its 2007 sale to Qiagen. He currently is a member of the board of LipoScience, Inc., a publicly traded company (traded on the Nasdaq Global Select market) in the in vitro diagnostics industry developing and marketing diagnostic tests based on nuclear magnetic resonance technology. Mr. Landon is also a trustee of Christiana Care Health System and a member of the

51


TABLE OF CONTENTS

board of advisors foran advisor to Water Street Healthcare Partners. Mr. Landon received his B.S. in Chemical Engineeringchemical engineering from the University of Arizona. Mr. Landon’s qualifications for serving on the Board of Directors include extensive executive experience in the life science industry, with particular experience with medical products businesses, and broad executive compensation knowledge and committee experience.

Michael R. Merson was appointed to our Board of Directors in July 2008. Mr. Merson is chair of the nominating and governance committee and is a member of the audit committee of AspenBio Pharma. Since 2003, Mr. Merson has served on the board and was elected Chairman in 2004 of CareFirst — Blue Cross/Blue Shield, the sixteenth largest health insurer in the United States with annual revenues of approximately $7.0 billion and covering over 3.2 million insured individuals. CareFirst is part of the BlueCross/Blue Shield group of insurance providers that collectively cover 100 million lives in the United States. Mr. Merson previously held director and executive officer positions, primarily President and/or CEO with MedStar Health, Helix Health, Inc., Franklin Square Hospital Center, and Preferred Health Network. He continues to provide consulting services to primarily healthcare related enterprises, focused on merger and acquisition, goal setting, business and governance issues, and executive compensation and benefits through Michael R. Merson, LLC and Yaffe & Company, consultants. He received a B.S.B.A. from the University of Denver and an M.B.A. from The George Washington University. Mr. Merson’s qualifications for serving on the Board of Directors includes health insurance company executive experience and extensive experience in the health care provider industry.

Gregory Pusey became a director of AspenBio Pharma, Inc. in February 2002. Throughout his involvement with AspenBio, he has assisted with financings, transactions and strategic matters. Over the years Mr. Pusey has served AspenBio as a member of the Board of Directors, served as Chairman from May 2003 to January 2009 and in January 2010 became a Vice President of the Company. Mr. Pusey is a director and assistant secretary of Bactolac Pharmaceutical, Inc., a privately held company engaged in manufacturing and marketing of vitamins and nutritional supplements. Since 1988, Mr. Pusey has been the President and a director of Cambridge Holdings, Ltd. which has distributed almost all of its assets and has limited activities. Until his resignation in April 2011, Mr. Pusey had served as a director of PepperBall Technologies, Inc. and its predecessors, since 2002. Over the last 35 years, Mr. Pusey has helped a variety of companies with corporate development and financing activities. Mr. Pusey graduated from Boston College with a Bachelor of Science degree in Finance. Mr. Pusey’s qualifications for serving on the Board of Directors include extensive fundraising and financial expertise, particularly in publicly traded companies.

Mark Ratain, M.D. was appointed to the board of AspenBio Pharma in March 2008 and is a member of the compensation committee and the nominating and governance committee. He previously (1998 – 2008) served as a director of DATATRAK International, Inc., a publicly traded company providing services to entities engaged in clinical trials. Dr. Ratain is a hematologist/oncologist and a clinical pharmacologist. He is the Leon O. Jacobson Professor of Medicine, Director of the Center for Personalized Therapeutics, and Associate Director for Clinical Sciences of the Comprehensive Cancer Center at the University of Chicago. He has authored and co-authored more than 350 articles and book chapters. He received his A.B. degree in Biochemical Sciences from Harvard University, and his M.D. from the Yale University School of Medicine. Dr. Ratain’s qualifications for serving on the Board of Directors include medical practice expertise, previous public company board experience and broad knowledge of medicine.

David E. Welch became a director of AspenBio Pharma in October 2004. Mr. Welch is chair of the AspenBio Pharma audit committee.Audit Committee and a member of the Compensation Committee. Mr. Welch has served since April 2004 as Vice President and Chief Financial Officer of American Millennium Corporation, Inc., a private company (publicly traded until June 2010) located in Golden, Colorado. Mr. Welch formerly served as a director of PepperBall Technologies, Inc. He also is a self-employed financial consultant. From July 1999 to June 2002, Mr. Welch served as Chief Financial Officer, Secretary and Treasurer of Active Link Communications, Inc., another publicly traded


TABLE OF CONTENTS

company. During 1998, he served as Chief Information Officer for Language Management International, Inc., a multinational translation firm located in Denver, Colorado. From 1996 to 1997, he was Director of Information Systems for Mircromedex,Micromedex, Inc., an electronic publishing firm, located in Denver, Colorado. Mr. Welch also serves on the Boardboard of Directorsdirectors of Communication Intelligence Corporation, a publicly traded company. He received a B.S. degree in accounting from the University of Colorado. Mr. Welch is a Certified Public Accountant,

52


TABLE OF CONTENTS

certified public accountant, licensed in the state of Colorado. Mr. Welch’s qualifications for serving on the

Stephen A. Williams, MB, BS, Ph.D. joined our Board of Directors include financialeffective May 1, 2013 and information systems expertise, particularlyupon joining the Board, he became a member of the Compensation Committee. Dr. Williams is the Chief Medical Officer of SomaLogic, Inc., a position he has held since 2009. Prior thereto, he worked at Pfizer from 1989 until 2007. In 1989 he joined Pfizer U.K. in publicly traded companies.its experimental medicine division and worked on a variety of programs including asthma, irritable bowel syndrome, migraine, depression and urinary incontinence. Dr. Williams moved to the U.S. in 1993 with Pfizer and worked on programs in inflammatory bowel disease, stroke, psychosis and head injury. He created Pfizer’s Clinical Technology Group in 1997, which became a global group maintaining five research sites with the objective of validating clinical biomarkers and measurements, and was promoted to Pfizer Vice President in 2006. Dr. Williams’ undergraduate degree is a BSc (hons) in physiology. He trained as a physician at Charing Cross and Westminster Medical School, University of London, where he earned degrees in surgery and medicine (MB BS) and, following his internships, returned to the same institution for a Ph.D. in medicine and physiology. Subsequently, Dr. Williams performed three years of residency in diagnostic imaging at the University of Newcastle upon Tyne from 1989 to 1991. Dr. Williams was on the National Advisory Council to the National Institute of Biomedical Imaging and Bioengineering from 2003 to 2007 and on the Executive Committee of the FNIH-led Biomarkers Consortium from 2005 to 2007.

Executive Officers

Stephen T. Lundy — see above under “Board of Directors.”

Gregory S. PuseyDonald R. Hurd became our Chief Commercial Officer in May 2012. He is a seasoned executive with over 30 years of experience in the medical diagnostic and device industry, having worked in large diagnostic companies as well as start-ups. Mr. Hurd joined Venaxis from BioBehavorial Diagnostics where he most recently served as Vice President — see above under “BoardSales from July 2010 to March 2012. Prior industry positions include Vice President — Marketing/Sales at MicroPhage, Vice President North American Customer Operations, Siemens Healthcare Diagnostics, U.S. Director of Directors.”Sales, Bayer Healthcare Diagnostics. Mr. Hurd received a B.S. in business administration and is a military veteran with the United States Navy.

Jeffrey G. McGonegal became our Chief Financial Officer of the Company in June 2003, was appointed Corporate Secretary in January 2010 and served as interim President in December 2004 and January 2005. Mr. McGonegal served from 2003 to January 1, 2011 as Chief Financial Officer of PepperBall Technologies, Inc. Mr. McGonegal also serves on a limited part-time basis as Senior Vice President — Finance of Cambridge Holdings, Ltd., a small publicly held company with limited business activities. Mr. McGonegal served as Chief Financial Officer of Bactolac Pharmaceutical, Inc. and had been associated with its predecessors through October 2006, a company (publicly held until September 2006) engaged in manufacturing and marketing of vitamins and nutritional supplements. From 1974 to 1997, Mr. McGonegal was an accountant with BDO Seidman LLP. While at BDO Seidman LLP, Mr. McGonegal served as Managing Partner of the Denver, Colorado office. Until his resignation onin March 21, 2012, Mr. McGonegal was elected in 2005 to serve on the board of Imagenetix, Inc., a publicly held company in the nutritional supplements industry. He received a B.A. degree in Accountingaccounting from Florida State University.

Qualifications, Attributes and Skills of our Board of Directors

Donald R. Hurd becameThe Nominating and Corporate Governance Committee (the “Nominating Committee”) screens director candidates and evaluates the Senior Vice Presidentqualification and Chief Commercial Officerskills applicable to us of the Company on May 23, 2012, previously having servedexisting members of the Board. In overseeing the nomination of candidates for election, and the qualifications and skills of incumbent directors, the Nominating Committee, and subsequently the Board, seeks qualified individuals with outstanding records of success in their chosen careers, the skills to perform the role of director, and the time and motivation to perform as a consultantdirector. Directors are expected to bring specialized talents to the Company since May 1, 2012. Mr. HurdBoard that add value to the Board’s deliberative process and advance our business goals. The Board has more than 30 years ofdetermined that experience within vitro diagnostic companies and joins AspenBio from BioBehavioral Diagnostics, where he most recently served as Vice President Sales from 2010 to 2012. Prior positions include: Vice President Marketing/Sales at MicroPhage from 2009 to 2010; Vice President North American Customer Operations, Siemens Healthcare Diagnostics from 1998 to 2009; and U.S. Director of Sales, Bayer Healthcare Diagnostics. Mr. Hurd received a Bachelor of Science in Business Administration and was a military veteran with the United States Navy.


53


 

TABLE OF CONTENTS

DIRECTOR COMPENSATION

Since February 1, 2008, each non-employee director receives cash compensation of $1,000 per month. On October 7, 2010, upon becoming non-executive Chairlife sciences industries, financial and investment experience, publicly held company experience and governmental experience are generally useful qualifications for directors, and the composition of the Board reflects such assessment. In 2012, in connection with our re-branding, the Nominating Committee and the Board assessed the skills and qualifications of our Board members and determined it would be helpful to recruit additional Board members with scientific, regulatory and life sciences management skills. The appointment of Dr. Evans and Dr. Williams to the Board arose as part of those actions. All of the incumbent directors exhibit outstanding records of success in their chosen careers and have demonstrated their ability to devote the time and energy necessary to serve on the Board and to advance our business goals and strategies. The directors have the following additional qualifications and skills that make them productive members of the Board:

Stephen Lundy — over 20 years’ experience in drug and diagnostic development companies, including experience leading the commercial launch of diagnostic products and participation in merger and acquisition transactions in the industry;
Gail Schoettler began receiving cash— business acumen, years of public service and extensive public company board, business and financial experience;
Susan Evans — over 30 years’ experience in the in vitro diagnostics industry, including development of numerous successful diagnostic tests;
Daryl Faulkner — significant chief executive and senior executive experience in medical device and medical diagnostics publicly traded companies, both national and global;
John Landon — extensive executive experience in the life science industry, with particular experience with medical products businesses, and broad executive compensation of $2,000 per month. Our independent directors typically receive a stock option upon joining and additional options over time, generally annually. As additional compensation for service as non-executive chair, Ms. Schoettler receives awards equal to 1.5 times the awards made to the other non-employee directors when such awards are made. The following information does not reflect the 1-for-6 reverse stock split anticipated to be effected upon this offering. The directors are also reimbursed for all expenses incurred by them in attending boardknowledge and committee meetings.

experience;
David Welch — financial and information systems expertise, particularly in publicly traded companies; and
Stephen Williams — medical, scientific and clinical biomarker discovery and development experience.

Family Relationships

   
Name Cash Fees Paid
($)
 Option Awards
($)(8)
 Total
($)
Gail Schoettler(1)  24,000   36,600   60,600 
Daryl J. Faulkner(2)  12,000   24,390   36,390 
Douglas Hepler(3)  12,000   24,390   36,390 
John Landon(4)  12,000   24,390   36,390 
Michael R. Merson(5)  12,000   24,390   36,390 
Mark Ratain, M.D.(6)  12,000   24,390   36,390 
David Welch(7)  12,000   24,390   36,390 

(1)On January 5, 2011, Ms. Schoettler was granted options to purchase 15,000 shares at $2.95 per share, vesting over three years in arrears and expiring in ten years. As of December 31, 2011, Ms. Schoettler held a total of 115,000 options to purchase shares of our common stock.
(2)On January 5, 2011, Mr. Faulkner was granted options to purchase 10,000 shares at $2.95 per share, vesting over three years in arrears and expiring in ten years. As of December 31, 2011, Mr. Faulkner held a total of 125,000 options to purchase shares of our common stock.
(3)On January 5, 2011, Mr. Hepler was granted options to purchase 10,000 shares at $2.95 per share, vesting over three years in arrears and expiring in ten years. As of December 31, 2011, Mr. Hepler held a total of 90,000 options to purchase shares of our common stock.
(4)On January 5, 2011, Mr. Landon was granted options to purchase 10,000 shares at $2.95 per share, vesting over three years in arrears and expiring in ten years. As of December 31, 2011, Mr. Landon held a total of 43,407 options to purchase shares of our common stock.
(5)On January 5, 2011, Mr. Merson was granted options to purchase 10,000 shares at $2.95 per share, vesting over three years in arrears and expiring in ten years. As of December 31, 2011, Mr. Merson held a total of 43,135 options to purchase shares of our common stock.
(6)On January 5, 2011, Dr. Ratain was granted options to purchase 10,000 shares at $2.95 per share, vesting over three years in arrears and expiring in ten years. As of December 31, 2011, Dr. Ratain held a total of 43,263 options to purchase shares of our common stock.
(7)On January 5, 2011, Mr. Welch was granted options to purchase 10,000 shares at $2.95 per share, vesting over three years in arrears and expiring in ten years. As of December 31, 2011, Mr. Welch held a total of 90,000 options to purchase shares of our common stock.
(8)The “Option Awards” columns reflect the grant date fair value for all stock option awards granted to non-employee directors under the Plan during 2010. These amounts are determined in accordance with FASB Accounting Standards Codification 718 (previously known as Statement of Financial Accounting Standards No. 123(R)) (ASC 718), without regard toThere are no family relationships among any estimate of forfeiture for service vesting. Assumptions used in the calculation of the amounts in this column are included in footnotes 1 and 7 to the Company’s audited financial statements for the fiscal year ended December 31, 2011.

Independence of the Board of Directorsour directors or executive officers.

Director Independence

Our Board of Directors currently consists of Ms. Schoettler, Drs. Evans and Williams and Messrs. Lundy, Faulkner, Hepler, Landon Merson, Pusey, Ratain and Welch. The Company defines “independent” as that term is defined in Rule 5605(a)(2) of the NASDAQNasdaq listing standards. For 2011,2012, Ms. Schoettler and Messrs. Faulkner, Hepler, Landon Merson, Ratain and Welch qualified as independent and none of them have any material relationship with the Companyus that might interfere with his or her exercise of independent judgment. In making the determination as to the independence of Mr. Faulkner, the Board considered the interim nature of his service as CEO of the Company for a brief period ending in March 2010, and his independence from us in all other respects.

54


TABLE OF CONTENTS

The non-employee directors, with the exception of Ms. Schoettler, receive cash compensation of $1,000 per month as compensation for service on the Board. MsMs. Schoettler, the non-executive chairChair of the board,Board, receives compensation of $2,000 per month as compensation for service on the Board. The independent directors typically receive a stock option grant upon joining the Board and additional stock option grants, generally annually, for service on the Board. Effective October 2010, Ms. Schoettler began receiving equity awards equal to 1.5 times the amount granted to other non-employee directors when such awards are issued. The directors are also reimbursed for all expenses incurred by them in attending board meetings.

Board Committees

The Board of Directors has established three standing committees: audit, nominating and corporate governance and compensation. Each of our audit, nominating and corporate governance and compensation committees operates under a charter that has been approved by the Board of Directors. The Board of Directors has also adopted corporate governance guidelines to assist our Board in the exercise of the Companyits duties and responsibilities.


TABLE OF CONTENTS

Audit Committee:  The Company hasWe have a separately designated standing Audit Committeeaudit committee established in accordance with Section 3(a) (58) (A) of the Exchange Act. ThreeFour of the Company’sour directors serve on the Audit Committee — David Welch (who serves as Chair of the Committee), Gail Schoettler, Daryl Faulkner and Michael Merson.Susan A. Evans. Mr. Welch has been designated as the financial expert on the Audit Committee. Each Audit Committee member meets the definition of independence for audit committeeAudit Committee membership as required by the NASDAQNasdaq listing standards. The amendedAmended and restatedRestated Audit Committee Charter is available on our website at http://www.aspenbiopharma.comwww.venaxis.com.

Nominating and Corporate Governance Committee:Committee.  The Nominating Committee consists of: Michael Mersonof Daryl Faulkner (who serves as Chair of the Committee), Douglas Hepler Ph.D., Mark Ratain M.D.Gail Schoettler and John Landon, each of whom meet the NASDAQNasdaq listing standards for independence. Duties of the Nominating Committee include oversight of the process by which individuals may be nominated to our Board of Directors. The Nominating Committee charter is available on our web sitewebsite athttp://www.aspenbiopharma.comwww.venaxis.com. There have been no material changes to the procedures by which security holders may recommend nominees to the Company’sour Board of Directors. The specific process for evaluating new directors, including shareholder-recommended nominees, will vary based on an assessment of the then current needs of the Board and the Company. The Nominating Committee will determine the desired profile of a new director, the competencies they are seeking, including experience in one or more of the following: highest personal and professional integrity, demonstrated exceptional ability and judgment and who shall be most effective in conjunction with the other nominees to the board,Board, in collectively serving the long-term interests of the shareholders. Candidates will be evaluated in light of the target criteria chosen. The Nominating Committee does not have a formal diversity policy; in addition to the foregoing, it considers race and gender diversity in selection of qualified candidates.

Compensation Committee:  The Company’sOur Compensation Committee is comprised of Douglas Hepler Ph.D.John Landon (who serves as Chair of the Committee), Mark Ratain M.D.David Welch, Gail Schoettler and John Landon,Stephen Williams, each of whom is an independent director. The amended and restated Compensation Committee Charter is available on our website athttp://www.aspenbiopharma.comwww.venaxis.com.

Code of Ethics and Whistle Blower Policy

In December 2003,March 2013, the Board of Directors updated and adopted a Code of Ethics that applies to itsour directors, executive officers (including its chief executive officer, chief operating officer, chief medical officer, chief financial officer, chief scientific officer, controller and other persons performing similar functions), and allmanagement employees generally. The Code of Business Ethics is available on our website atwww.aspenbiopharma.comwww.venaxis.com. We intend to post any material amendments to or waivers of, our Code of Ethics that apply to our executive officers, on this website. In addition, our Whistle Blower Policy is available on our website atwww.aspenbiopharma.comwww.venaxis.com..

Board Leadership Structure and Role in Risk Management

The Board of Directors believes that separating the positions of Chair of the Board and Chief Executive Officer provides the best leadership structure for us at this time. Gail Schoettler serves as the non-executive Chair of the Board. Separating these positions allows the Chief Executive Officer to focus on the day-to-day business, while allowing the Chair to lead the Board of Directors in its fundamental role of providing advice to and independent oversight of management. The Board of Directors also believes that this structure ensures a greater role for the independent directors in our oversight and active participation of the independent directors in setting agendas and establishing priorities and procedures for the work of the Board of Directors.

The Board of Directors is actively involved in oversight of risks that could affect us. This oversight is conducted primarily through committees of the Board of Directors, but the full Board of Directors has retained responsibility for general oversight of risks. The Board of Directors satisfies this responsibility through full reports by each committee chair regarding the committee’s considerations and actions, as well as through regular reports directly from officers responsible for management of particular risks within the Company. The Board of Directors believes that full and open communication between management and the Board of Directors is essential for effective risk management and oversight.

Director Compensation

Since February 1, 2008, each non-employee director receives cash compensation of $1,000 per month. On October 7, 2010, upon becoming non-executive Chair of the Board, Gail Schoettler began receiving cash compensation of $2,000 per month. To conserve cash, each non-employee director agreed to defer receipt of


55


 

TABLE OF CONTENTS

50% of the cash compensation for the months of February through June 2012, resulting in a total deferral of $5,000 for Gail Schoettler and $2,500 each for the remaining directors. The deferral remains unpaid to the present. Our non-employee directors typically receive a stock option upon joining and additional options over time, generally annually. As additional compensation for service as non-executive chair, Ms. Schoettler receives awards equal to 1.5 times the awards made to the other non-employee directors when such awards are made. The directors are also reimbursed for all expenses incurred by them in attending Board and committee meetings.

   
Name Cash Fees
($)
 Option Awards
($)(5)
 Total
($)
Gail Schoettler(1)  24,000   101,664   125,664 
Daryl Faulkner(2)  12,000   101,610   113,610 
John Landon(3)  12,000   44,494   56,494 
David Welch(4)  12,000   77,115   89,115 

(1)On April 2, 2012, Ms. Schoettler was granted options to purchase 2,500 shares at $4.26 per share, vesting over three years in arrears and expiring in ten years. On December 11, 2012, Ms. Schoettler was granted “engagement award” options to purchase 43,340 shares at $2.10 per share, vesting 100% on the one year anniversary of the grant date. As of December 31, 2012, Ms. Schoettler held a total of 65,010 options to purchase shares of our common stock.
(2)On April 2, 2012, Mr. Faulkner was granted options to purchase 1,667 shares at $4.26 per share, vesting over three years in arrears and expiring in ten years. On December 11, 2012, Mr. Faulkner was granted “engagement award” options to purchase 45,004 shares at $2.10 per share, vesting 100% on the one year anniversary of the grant date. As of December 31, 2012, Mr. Faulkner held a total of 67,506 options to purchase shares of our common stock.
(3)On April 2, 2012, Mr. Landon was granted options to purchase 1,667 shares at $4.26 per share, vesting over three years in arrears and expiring in ten years. On December 11, 2012, Mr. Landon was granted “engagement award” options to purchase 17,806 shares at $2.10 per share, vesting 100% on the one year anniversary of the grant date. As of December 31, 2012, Mr. Landon held a total of 26,709 options to purchase shares of our common stock.
(4)On April 2, 2012, Mr. Welch was granted options to purchase 1,667 shares at $4.26 per share, vesting over three years in arrears and expiring in ten years. On December 11, 2012, Mr. Welch was granted “engagement award” options to purchase 33,340 shares at $2.10 per share, vesting 100% on the one year anniversary of the grant date. As of December 31, 2012, Mr. Welch held a total of 50,010 options to purchase shares of our common stock.
(5)The “Option Awards” columns reflect the grant date fair value for all stock option awards granted to non-employee directors under the Plan during 2012. These amounts are determined in accordance with ASC 718, without regard to any estimate of forfeiture for service vesting. Assumptions used in the calculation of the amounts in this column are included in footnotes 1 and 6 to our audited financial statements for the fiscal year ended December 31, 2012.

TABLE OF CONTENTS

EXECUTIVE COMPENSATION

Compensation Discussion and Analysis

This section describes our compensation program for our named executive officers (“Named Executive Officers”) during the fiscal year ended December 31, 2012. The following discussion focuses on our compensation program and compensation-related decisions for fiscal year 2012 and also addresses why we believe our compensation program is appropriate for us.

Compensation Philosophy and Objectives

It is our philosophy to link executive compensation to corporate performance and to create incentives for management to enhance Company value. The following objectives have been adopted by the Compensation Committee as guidelines for compensation decisions:

provide a competitive total executive compensation package that enables us to attract, motivate and retain key executives;
integrate the compensation arrangements with our annual and long-term business objectives and strategy, and focus executives on the fulfillment of these objectives; and
provide variable compensation opportunities that are directly linked with our financial and strategic performance.

Procedures for Determining Compensation

Our Compensation Committee has the overall responsibility for designing and evaluating the salaries, incentive plan compensation, policies and programs for our Named Executive Officers. The Compensation Committee relies on input from our Chief Executive Officer regarding the Named Executive Officers (other than himself), and on an analysis of our corporate performance. With respect to the compensation for the Chief Executive Officer, the Compensation Committee evaluates the Chief Executive Officer’s performance and sets his compensation. With respect to our corporate performance as a factor for compensation decisions, the Compensation Committee considers, among other aspects, our long-term and short-term strategic goals and development goals.

Our Chief Executive Officer plays a significant role in the compensation-setting process of the other Named Executive Officers and makes recommendations to the Compensation Committee concerning performance objectives and salary and bonus levels for the other Named Executive Officers. The Compensation Committee, at least annually, then discusses the recommendations with the Chief Executive Officer. The Compensation Committee may, in its sole discretion, approve, in whole or in part, the recommendations of the Chief Executive Officer. The Compensation Committee makes recommendations to the full Board of Directors for their final approval regarding the overall compensation structure for the Named Executive Officers. In fiscal year 2012, the Compensation Committee and the Board approved the Chief Executive Officer’s recommendations for salary and bonus with respect to each of the other Named Executive Officers.

In determining the adjustments to the compensation of our Named Executive Officers, we participated in the Radford Global Life Sciences Survey of compensation. Information obtained from this survey was used in summary form for informational purposes for our compensation considerations. We do not use such information or other information to benchmark the compensation of our Named Executive Officers. Our Compensation Committee also relied on their experience with other public companies, and the Radford compensation data and those experiences informed and guided our compensation decisions for fiscal 2012.

As a smaller reporting company, we were not required to seek advisory shareholder approval of the compensation of our Named Executive Officers at the annual meeting of shareholders held in 2012. Shareholders are being asked to approve, on an advisory basis, the compensation of our Named Executive Officers at the 2013 annual meeting of shareholders scheduled to be held on June 11, 2013.


TABLE OF CONTENTS

Elements of Executive Compensation

The compensation of our Named Executive Officers consists primarily of four major components:

base salary;
annual incentive awards;
long-term equity awards; and
other benefits.

Base Salary

The base salary of each of our Named Executive Officers is determined based on an evaluation of the responsibilities of that particular position, each Named Executive Officer’s historical salary earned in similar management positions with us or other companies, and the Radford compensation data described above. A significant portion of each Named Executive Officer’s total compensation is in the form of base salary. The salary component is designed to provide the Named Executive Officers with consistent income and to attract and retain talented and experienced executives capable of managing our operations and strategic growth. Annually, the performance of each Named Executive Officer is reviewed by the Compensation Committee using information and evaluations provided by the Chief Executive Officer with respect to the other Named Executive Officers and its own assessment of the Chief Executive Officer, taking into account our operating and financial results for the year, a subjective assessment of the contribution of each Named Executive Officer to such results, the achievement of our strategic growth and any changes in our Named Executive Officers’ roles and responsibilities.

Annual Incentive Plan

The Named Executive Officers participated in our annual incentive plan for senior management (the “Incentive Plan”) for 2012. Under the Incentive Plan, management develops annual corporate goals and milestone objectives that are then approved by the Compensation Committee and the Board. The Incentive Plan is designed to recognize and reward our employees, including the Named Executive Officers, for contributing towards the achievement of our annual corporate business plan. These annual incentive awards are designed to reward near-term operating performance and the achievement of milestones critical to our success in both the near and the long-term. The Compensation Committee believes the Incentive Plan serves as a valuable short-term incentive program for providing cash bonus opportunities for our employees upon achievement of targeted operating results. The 2012 Incentive Plan was 45% weighted on goals related to advancement of development activities surrounding our appendicitis product, with the balance weighted between fundraising, animal health advances and additional public company considerations. Specifically, the Incentive Plan goals were:

Advance onAPPY1 developments including submission of a Pre-IDE package to the FDA, establish a path to proceed to a clinical trial based upon FDA feedback, commence enrollment in a clinical trial and completion of CE Marking (45% of total);
Achieve specific fundraising, investor relations and public company goals (45% of total); and
Complete a specific strategic animal health transaction (10% of total).

Each of the Incentive Plan goals categories included a potential stretch goal for successful achievement above the targeted expectations established in the goals.

For fiscal 2012 based upon a review of the goals and achievements, the Compensation Committee and the Board determined that an aggregate achievement level of 92.5% was earned on the 2012 Incentive Plan goals. This achievement level included a stretch goal achievement on the fund-raising goal, achievement of a substantial portion of the development goals and the successful execution of an exclusive license agreement with respect to the Company’s animal health assets. The bonus awards were paid in the first quarter of 2013.

Long-Term Equity Awards

The Compensation Committee believes that it is essential to align the interests of the Named Executive Officers with the interests of our shareholders, and believes the best way to accomplish this alignment is


TABLE OF CONTENTS

through awards of long-term, equity-based compensation. The Compensation Committee has also identified the need to recruit and retain experienced, high performing executives, and equity-based awards assist in such recruitment and retention. Such awards are made under the Amended and Restated 2002 Stock Incentive Plan, as amended (the “Plan”).

We have granted stock options as incentive stock options in accordance with Section 422 of the Code, subject to the volume limitations contained in the Code, as well as non-qualified stock options. Generally, for stock options that do not qualify as incentive stock options, we are entitled to a tax deduction in the year in which the stock options are exercised equal to the spread between the exercise price and the fair market value, at the time of exercise, of the stock for which the stock option was exercised. The holders of the non-qualified stock options are generally taxed on this same amount in the year of exercise. For stock options that qualify as incentive stock options, we do not receive a tax deduction, and the holder of the stock option may receive more favorable tax treatment than he or she would for a non-qualified stock option. Historically, we have primarily granted incentive stock options to provide these potential tax benefits to our executives and because of the limited expected benefits to us of the potential tax deductions as a result of our historical net losses.

The Board of Directors made annual stock option awards to the Named Executive Officers in April 2012. The Named Executive Officer annual awards for stock options, other than the Chief Executive Officer, are generally awarded at the same level for each Named Executive Officer and have been based upon the same annual award levels as used for the grants to non-employee directors. The stock options generally have a term of ten years and are subject to time-based vesting over three years. In addition, for certain Named Executive Officers, performance-based vesting tied to achievement of specific corporate goals is used to provide additional incentives to tie compensation more closely to our defined needs.

In July 2012, the Compensation Committee engaged Mercer compensation consultants to assist the Compensation Committee in its evaluation of our equity-based compensation. Due to the prolonged product development and approval timeline that we have encountered, we had been unable to achieve regulatory approval for our principal product,APPY1, and had experienced significant declines in its stock price over the past few years. In order to maintain compliance with the applicable Nasdaq listing standards, we had effected two shareholder-approved reverse stock split transactions, one on July 28, 2011, and the second on June 20, 2012, in conjunction with a common stock financing transaction. The Compensation Committee and the Board of Directors determined that the stock price decline and the impact of the reverse split transactions had negatively affected the incentive and compensatory nature of stock options previously granted to executive officers, other employees and non-employee directors — over 95% of then currently outstanding stock option awards were significantly “out-of-the money” and did not provide the desired incentive and compensation objectives. The Compensation Committee and the Board of Directors approved an amendment to the Plan to increase the number of shares available for awards under the Plan, and, following shareholder approval of such share increase, approved an “engagement awards” retention program to provide additional equity awards to executive officers, non-employee directors and other employees. The Compensation Committee met with Mercer representatives and sought advice from them, in their capacity as an independent compensation consultant, in developing this engagement award program. Mercer provided the Committee with its support of the proposed plan. Shareholder approval of the share increase was obtained at a special meeting held in December 2012, and the engagement awards were issued after receipt of such shareholder approval. The engagement awards made to the Named Executive Officers are included in the “Outstanding Equity Awards at Fiscal Year End” table.

We have adopted a Change in Control policy for the Plan. A “Change in Control” is defined under the Plan as (i) the acquisition, directly or indirectly, by any person or group (within the meaning of Section 13(d)(3) of the Exchange Act of the beneficial ownership of more than fifty percent of our outstanding securities, (ii) a merger or consolidation in which we are not the surviving entity, (iii) the sale or transfer or other disposition of all or substantially all of our assets, (iv) our complete liquidation or dissolution or (v) any reverse merger in which we are the surviving entity but in which securities possessing more than fifty percent of the total combined voting power of our outstanding securities are transferred. Under the adopted policy, in the event of a Change in Control, all outstanding unvested stock options and rights granted under the Plan and held by Directors and Named Executive Officers will fully vest. The Board believes that this acceleration of vesting of


TABLE OF CONTENTS

outstanding awards provides the executives at risk for job loss in any Change of Control with certainty as to the impact of the Change in Control on such long-term compensation.

The Compensation Committee periodically reviews long-term incentives to assure that our executive officers and other key employees are appropriately motivated and rewarded in a way that is aligned with our long-term financial results.

Agreements with Named Executive Officers

We have entered into employment agreements with, and provide post-employment benefits to, our Named Executive Officers as follows:

Chief Executive Officer — On March 24, 2010, we entered into an employment agreement with Mr. Lundy which provides that he serves at the pleasure of the Board of Directors unless the agreement is terminated by either party as provided in the agreement. The agreement provides in the event that Mr. Lundy’s employment is terminated by us for other than cause, or if such employment is terminated by the executive in the event of a change in control, severance payments based upon Mr. Lundy’s salary will be made for twelve months. In the event of death or disability, severance payments based upon Mr. Lundy’s salary will be made for three months.

Chief Financial Officer — On February 2, 2009, we entered into an employment agreement with Mr. McGonegal for a one-year term which automatically renews each anniversary thereafter (unless terminated by either party as provided in the agreement). The agreement provides in the event that Mr. McGonegal’s employment is terminated by us for other than cause, or if such employment is terminated by the executive in the event of a change in control, severance payments based upon Mr. McGonegal’s salary will be made for six months. In the event of death or disability, severance payments based upon Mr. McGonegal’s salary will be made for six months.

Chief Commercial Officer — On May 23, 2012, we entered into an employment agreement with Mr. Hurd that provides that he serves at the pleasure of the Board of Directors unless the agreement is terminated by either party as provided in the agreement. The agreement provides in the event that Mr. Hurd’s employment is terminated by us for other than cause, or if such employment is terminated by the executive in the event of a change in control, severance payments based upon Mr. Hurd’s salary will be made for six months. In the event of death or disability, severance payments based upon Mr. Hurd’s salary will be made for six months.


TABLE OF CONTENTS

Summary Compensation Table

This table provides disclosure, for fiscal years 20112012 and 20102011 for the Named Executive Officers, (NEOs), who are (1) any individual serving in the office of Chief Executive Officer (CEO) during any part of 20112012 and (2) the Company’sour two most highly compensated officers, other than the CEO, who were serving in such capacity on December 31, 2011.2012.

            
Named Executive Officer and Principal Position Year Salary
($)
 Option Awards(4)
($)
 Non-Equity Incentive Plan Compensation(5)
($)
 All Other Compensation
($)
 Total
($)
 Year Salary
($)
 Option Awards(4)
($)
 Non-Equity Incentive Plan Compensation(5)
($)
 All Other Compensation
($)
 Total
($)
Stephen T. Lundy,
Chief Executive Officer and President(1)
  2011   275,000   268,308      34,209   577,517   2012   283,910   216,875   118,220   32,681   651,666 
 2010   212,596   726,400   42,100   16,963   998,059   2011   275,000   268,308      34,209   577,517 
Jeffrey G. McGonegal,
Chief Financial Officer(2)
  2011   225,000   24,390      20,758   270,148   2012   225,000   115,130   72,800   21,131   434,061 
 2010   200,000   88,300   35,000   19,722   343,022   2011   225,000   24,390      20,758   270,148 
Erik S. Miller,
Vice President Marketing and
Business Development(3)
  2011   225,000   107,420      30,894   363,314 
 2010            47,625   47,625 
Donald R. Hurd,
Chief Commercial Officer(3)
  2012   134,167   144,841   55,800   13,955   348,763 

(1)Stephen T. Lundy joined the Companyus in 2010 as CEOChief Executive Officer and President with an annual salary of $275,000. Effective October 29, 2012, Mr. Lundy’s annual salary was increased to $325,000. Mr. Lundy also serves as a director of the Company; he does not receive additional compensation for serving in such role. Amounts included in “All Other Compensation” include: temporary living and travel accommodations he was provided at a total cost of $19,674 and $18,914 in 2012 and $7,024 in 2011, and 2010, respectively, and coverage under the Company’sour group medical plan at a total cost of $13,007 and $15,296 in 2012 and $9,939 in 2011, and 2010, respectively.
(2)Mr. McGonegal’s base compensation was adjusted to $225,000 effective January 1, 2011, as provided for under the terms of his employment agreement. The amountamounts included in “All Other Compensation” includesinclude the amount paid on his behalf for group medical benefits.
(3)Mr. MillerDonald Hurd joined the Company on January 17, 2011 as Vice President, Marketing and Business Development. Prior to joining the Company he served as a consultant to the Company. Amountsus in May 2012 with an annual base salary of $230,000. The amounts included in “All Other Compensation” include: consulting fees of $7,688 paid to Mr. Hurd prior to his employment, and temporary living and travel accommodations he was provided at a total cost of $11,694 in 2011, coverage under the Company’s group medical plan at a total cost of $7,700 in 2011 and consulting payments made prior to employment of $11,500 and $47,625 in 2011 and 2010. On May 11, 2012, Mr. Miller resigned from the Company.$6,268.
(4)The “Option Awards” columns reflect the grant date fair value for all stock option awards granted under the Plan during 20102011 and 2011.2012. These amounts are determined in accordance with FASB Accounting Standards Codification 718 (previously known as Statement of Financial Accounting Standards No. 123(R)) (ASC 718), without regard to any estimate of forfeiture for service vesting. Assumptions used in the calculation of the amounts in these columns for 20102011 and 20112012 are included in footnotes 1 and 76 to the Company’sour audited financial statements for the fiscal year ended December 31, 2011.2012.
(5)The “Non-Equity Incentive Plan Compensation” column reflects the annual cash bonuses earned under the Incentive Plan. The bonus amounts listed were earned for the fiscal year reported, but paid in the subsequent year.


56


 

TABLE OF CONTENTS

Outstanding Equity Awards at Fiscal Year End

The following table sets forth information regarding our outstanding equity awards as of December 31, 2011, for the Named Executive Officers:

     
Named Executive Officer Number of
Securities
Underlying
Unexercised
Options
Exercisable
(#)(1)
 Number of
Securities
Underlying
Unexercised
Options
Unexercisable
(#)(1)
 Equity
Incentive
Plan Awards:
Number of
Securities
Underlying
Unexercised
Unearned
Options
(#)
 Option
Exercise
Price
($)(1)
 Option
Expiration
Date
($)
Stephen T. Lundy(2)  46,667   33,333      11.40   3-24-2020 
       18,000      2.95   1-5-2021 
       80,000      3.40   7-8-2021 
Jeffrey G. McGonegal(3)  12,000         7.35   6-17-2013 
    28,000         6.05   1-19-2014 
    20,000         3.75   8-24-2014 
    10,000         4.00   3-24-2015 
    10,000         14.80   1-24-2017 
    8,000         33.15   1-17-2018 
    6,667   3,333      6.65   1-27-2019 
    3,333   6,667      11.00   1-19-2020 
       10,000      2.95   1-5-2021 
Erik S. Miller(4)     40,000      3.25   1-17-2021 
     
 Option Awards
Named Executive Officer Number of Securities Underlying Unexercised Options Exercisable
(#)
 Number of Securities Underlying Unexercised Options Unexercisable
(#)
 Equity Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned
Options
(#)
 Option
Exercise Price
($)
 Option
Expiration
Date
Stephen T. Lundy(1)  5,259   1,798      68.40   3-24-2020 
    691   1,382      17.70   1-5-2021 
    3,731   7,464      20.40   7-8-2021 
    8,332   4,168        3.96   4-30-2022 
       99,336        2.10   12-11-2022 
Jeffrey G. McGonegal(2)  2,000         44.10   6-17-2013 
    4,667         36.30   1-19-2014 
    3,334         22.50   8-24-2014 
    1,667         24.00   3-24-2015 
    1,667         88.80   1-24-2017 
    1,334         198.90   1-17-2018 
    1,667         39.90   1-27-2019 
    1,110   557      66.00   1-19-2020 
    555   1,112      17.70   1-5-2021 
    4,443   2,224        3.96   4-30-2022 
         52,676        2.10   12-11-2022 
Donald R. Hurd(3)  11,666   8334        3.42   5-23-2022 
       10,000        2.05   9-19-2022 
         40,000        2.10   12-11-2022 

(1)As adjusted to reflect the five to one reverse stock split effective July 29, 2011; does not reflect the 1-for-6 reverse stock split that is anticipated to be effected in connection with this offering.
(2)Includes options to purchase 80,000purchase: 7,057 shares at $11.40$68.40 per share which were granted on March 24, 2010, options to purchase 18,0002010; 2,073 shares at $2.95$17.70 per share which were granted on January 5, 2011 and options to purchase 80,0002011; 11,195 shares at $3.40$20.40 per share which were granted on July 8, 2011.2011; 12,500 shares at $3.96 per share granted on April 30, 2012; and 99,336 shares at $2.10 per share granted on December 11, 2012. All options are scheduled to vest 33% on the first and second anniversaries and 34% on the third anniversary of the grant date with the exception of 20,0001,667 shares ofunderlying the March 24, 2010 stock options, which vested early based upon their terms upon the completion of thea May 2010 capital raising transaction.transaction, the options granted on April 30, 2012, which vested 50% after six months and the remaining 50% equally over the following six months and the options granted December 11, 2012 vest 100% on the one year anniversary of the grant date.
(3)(2)Includes options to purchase 12,000purchase: 2,000 shares at $7.35$44.10 per share which were granted on June 17, 2003, options to purchase 28,0002003; 4,667 shares at $6.05$36.30 per share which were granted January 19, 2004, options to purchase 20,0002004; 3,334 shares at $3.75$22.50 per share which were granted August 24, 2004, options to purchase 10,0002004; 1,667 shares at $4.00$24.00 per share which were granted March 24, 2005, options to purchase 10,0002005; 1,667 shares at $14.80$88.80 per share which were granted January 24, 2007, options to purchase 8,0002007; 1,334 shares at $33.15$198.90 per share which were granted January 17, 2008, options to purchase 10,0002008; 1,667 shares at $6.65$39.90 per share which were granted on January 27, 2009, options to purchase 10,0002009; 1,667 shares at $ 11.0066.00 per share which were granted on January 19, 2010 and options to purchase 10,0002010; 1,667 shares at $2.95$17.70 per share which were granted on January 5, 2011.2011; 6,667 shares at $3.96 per share granted on April 30, 2012; and 52,676 shares at $2.10 per share granted on December 11, 2012. All options are scheduled to vest 33% on the first and second anniversaries and 34% on the third anniversary of the grant date with the exception of the stock options granted March 24, 2005, which were fully vested at grant date, the options granted on April 30, 2012, which vested 50% after six months and the remaining 50% equally over the following six months and the options granted December 11, 2012 vest 100% on the one year anniversary of the grant date.
(4)(3)Includes options to purchasepurchase: 20,000 shares at $3.42 per share granted on May 23, 2012; 10,000 shares at $2.05 per share granted on September 19, 2012; and 40,000 shares at $3.25$2.10 per share which were granted on January 17, 2011 and are scheduled toDecember 11, 2012. The options granted May 23, 2012 vest 33% on the first and second anniversaries

TABLE OF CONTENTS

and 34% on the third anniversary of the grant date. On Maydate, the options granted September 29, 2012 vest 50% after six months and the remaining 50% equally over the following six months, and the options granted December 11, 2012 Mr. Miller resigned fromvest 100% on the Company.one year anniversary of the grant date.

57


TABLE OF CONTENTS

Employment AgreementsOptions Exercised and Post-Employment BenefitsStock Vested

The Company has entered into employment agreements with, and provides post-employment benefits to, its NEOs as follows:

ChiefNone of the Named Executive Officer — On March 24, 2010, we entered into an employment agreement with Mr. Lundy for a one-year term which automatically renews each anniversary thereafter (unless terminated by either party as provided inOfficers exercised stock options during the agreement). The agreement provides in the event that the agreement is terminated by the Company for other than cause, or if terminated by the Executive in the event of a change in control, severance payments based upon Mr. Lundy’s salary will be made for twelve months. In the event of death or disability, severance payments based upon Mr. Lundy’s salary will be made for three months.year ended December 31, 2012.

Chief Financial Officer — On February 2, 2009, we entered into an employment agreement with Mr. McGonegal for a one-year term which automatically renews each anniversary thereafter (unless terminated by either party as provided in the agreement). The agreement provides in the event that the agreement is terminated by the Company for other than cause, or if terminated by the Executive in the event of a change in control, severance payments based upon Mr. McGonegal’s salary will be made for six months. In the event of death or disability, severance payments based upon Mr. McGonegal’s salary will be made for six months.

Post-Employment Benefits

The following table discloses the post-employment termination benefits that would have been received by the NEOsNamed Executive Officers if a termination event had occurred on December 31, 2011:2012:

          
Named Executive Officer Benefit Termination without Cause ($) Death or Disability ($) Change In Control (Single Trigger) ($) Change In Control (Double Trigger) ($) Benefit Termination without Cause
($)
 Death or Disability
($)
 Change In Control
(Single Trigger)
($)(2)
 Change In Control
(Double Trigger)
($)
Stephen T. Lundy  Severance   275,000   68,750      275,000   Severance   325,000   81,250      325,000 
  Options(1)             
  Total   275,000   68,750      275,000 
                       
Stephen T. Lundy  Options(1)         -45,695    
 Total   325,000   81,250   -45,695   325,000 
                 
  Severance   112,500   112,500      112,500   Severance   112,500   112,500      112,500 
  Options(1)             
  Total   112,500   112,500      112,500 
                     
Erik S. Miller(2)  Severance             
  Options(1)             
  Total             
Jeffrey G. McGonegal  Options(1)         -24,231    
 Total   112,500   112,500   -24,231   112,500 
                    
  Severance   115,000   115,000      115,000 
Donald R. Hurd  Options(1)         -23,500    
 Total   115,000   115,000   -23,500   115,000 

(1)As of December 31, 2011, all unvested stock options have exercise prices above theBased on a closing trading price of the Common Stockour common stock of $0.97, prior to the 1-for-6 reverse stock split expected to be effected immediately prior to the date of this prospectus. Therefore, no value is attributable to such stock options.$2.56 on December 31, 2012.
(2)On May 11, 2012, Mr. Miller resigned fromAcceleration upon consummation of a Change in Control (as defined in the Company.Plan) is provided for in certain employment agreements or in the Plan at the discretion of the Committee.

2002 Stock Incentive Plan


The CompanyTABLE OF CONTENTS

EQUITY COMPENSATION PLAN INFORMATION

We currently hashave one equity compensation plan. The 2002 Stock Incentive Plan, as amended (the Plan) was approved by the Board of Directors and adopted by the shareholders in 2002 and is used for plan-based awards for officers, other employees, consultants, advisors and non-employee directors. The Plan was amended and restated on May 20, 2002. At our annual meeting of shareholders heldJune 1, 2007 and further amended on June 9, 2008, our shareholders approved an amendment to the Plan increasing the number of shares reserved under the Plan to 920,000. On November 20, 2009, the Company’s shareholders approved an amendment to the PlanNovember 22, 2010, July 8, 2011, May 22, 2012 and December 11, 2012, primarily to increase the number of shares reservedavailable for awards under the Plan, to 1,220,000. On November 22, 2010, the Company’s shareholders approved an amendment to the Plan to increase the number of shares reserved under the Plan to 1,360,000. On July 8, 2011, the Company’s shareholders approved an amendment to the Plan to increase the number of shares reserved under the Plan to 1,500,000. All such share amounts are prior to the 1-for-6 reverse stock split expected to be effected immediately prior to the date of this prospectus.

58


TABLE OF CONTENTS

The Plan provides the Committee with the authoritymost recent increase to award: (i) options intended to qualify1,487,205 shares, as “incentive stock options” (“Incentive Options”) under Section 422 ofapproved by the Code; (ii) non-incentive stock options which are not intended to qualify as Incentive Options (“Non-Incentive Options”); and (iii) shares issuable under a “Right to Purchase.”

The Plan is intended to provide incentives to officers, directors, employees and other persons, including consultants and advisers, who contribute to the success of the Company by offering them the opportunity to acquire an ownership interest in it. The Board of Directors believes that this also helps align the interests of the Company’s management and employees with the interests of shareholders. The terms of the Plan concerning the Incentive Options and Non-Incentive Options are substantially the same except that only employees of the Company are eligible to receive Incentive Options; employees and other persons are eligible to receive Non-Incentive Options, and Incentive Stock Options are subject to certain restrictions and limitations in compliance with Section 422 of the Code. The number of shares reserved for issuance under the Plan is a maximum aggregate so that the number of Incentive Options and/or Non-Incentive Options that may be granted reduces the number of Rights to Purchase which may be granted, and vice versa.

The following table gives information about the Company’s Common Stockour common stock that may be issued upon the exercise of options and rights under the Company’s planPlan as of December 31, 2011 prior to the 1-for-6 reverse stock split expected to be effected upon the pricing of the offering:2012:

      
Plan Category Number of securities to
be issued upon exercise
of outstanding options
 Weighted average
exercise price of
outstanding options
 Number of securities
remaining available for
future issuance
 Number of securities to be issued upon exercise of outstanding options Weighted average exercise price of outstanding options Number of securities remaining available for future issuance
Equity compensation plans approved by security holders  1,291,485  $8.99   156,306   707,940  $13.98   779,265 
Equity compensation plans not approved by security holders                  
Total  1,291,485  $8.99   156,306   707,940  $13.98   779,265 

On April 17, 2013, the Board of Directors adopted an amendment increasing the total shares reserved under the Plan by 425,000 from 1,487,205 to 1,912,205, with such amendment being subject to shareholder approval. The amendment is being submitted to shareholders for approval at the annual meeting of shareholders on June 11, 2013.

Other Benefits

Medical insurance — The Company offers health insurance as well as voluntary coverage for dental and vision to its qualifying employees. All covered employees pay a portion of health insurance and pay all vision and dental premiums.

Perquisites and other benefits — We offer our NEOsNamed Executive Officers modest perquisites and other personal benefits that we believe are reasonable and in our best interest and generally in line with benefits we offer to all of our employees. See Executive“Executive Compensation — Summary compensation table.table.

Severance benefits — We have entered into employment agreements with certain of our NEOs.each Named Executive Officer. These agreements provide our NEOsNamed Executive Officers with certain severance benefits in the event of involuntary termination. See Executive“Executive Compensation — Employment agreements and post-employment benefits.

Pension benefits — The Company hasWe have no defined benefit plans, supplemental executive retirement plans or actuarial plans.

Nonqualified defined contributionDefined Contribution and other deferred compensation plansOther Deferred Compensation Plans — The Company doesWe do not have a defined contribution plan and has not contributed to a deferred compensation plan.


59


 

TABLE OF CONTENTS

CERTAIN RELATIONSHIPS AND RELATED PARTYPERSON TRANSACTIONS

The Company’sAmended and Restated Audit Committee is charged with reviewing and approvingCharter directs our Audit Committee to conduct an appropriate review of all proposed related person transactions in advance.transactions. Our executive officers, directors and principal shareholders, including their immediate family members, are not permitted to enter into a related person transaction with us without the consent of our Audit Committee.

Except for the employment agreements previously entered into between the Companyus and certain of itsour executive officers (as described under “Agreements with Named Executive Compensation — Employment Agreements and Post-Employment BenefitsOfficers”), since January 1, 2011,2012, none of theour directors or executive officers, of the Company, nor any person who owned of record or was known to own beneficially more than 5% of the Company’sour outstanding shares of its Common Stock,common stock, nor any associate or affiliate of such persons or companies, has any material interest, direct or indirect, in any transaction, or in any proposed transaction, which has materially affected or will affect the Company.us.


60


 

TABLE OF CONTENTS

PRINCIPAL SHAREHOLDERSSECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

The number of shares of the Company’sour common stock outstanding at the close of business on April 30, 20121, 2013 was 9,658,321. All share amounts are prior to the 1-for-6 reverse stock split expected to be effected immediately prior to the date of this prospectus.9,954,380. The following table sets forth the beneficial ownership of the Company’s Common Stockour common stock as of April 30, 20121, 2013 by each Company directorof our directors and each executive officer then serving, by all directors and executive officers as a group, and sets forth the number of shares of Company common stock owned by each person who owned of record, or was known to own beneficially, more than 5% of the outstanding shares of common stock. Beneficial ownership is determined in accordance with Rule 13d-3 under the Exchange Act. In computing the number of shares beneficially owned by a person or a group and the percentage ownership of that person or group, shares of our common stock subject to options currently exercisable or exercisable within 60 days after April 30, 20121, 2013 are deemed outstanding, but are not deemed outstanding for the purpose of computing the percentage ownership of any other person. To the knowledge of theour directors and executive officers, of the Company, as of April 30, 2012,1, 2013, there are no persons and/or companies who or which beneficially own, directly or indirectly, shares carrying more than 5% of the voting rights attached to allour outstanding shares, of the Company, other than as set forth below. Unless otherwise indicated, the address of each individual named below is the address of the company,Company, 1585 South Perry Street, Castle Rock, CO 80104.

Beneficial Ownership Table

   
Name and Address Number of
Shares
 Percentage
Ownership as
of April 30,
2012
 Percentage
Ownership
immediately
following this
Offering
Stephen T. Lundy(1)  66,000    *      
Gail S. Schoettler(2)  104,667   1.1     
Daryl J. Faulkner(3)  112,000   1.1     
Douglas I. Hepler(4)  88,260    *      
John H. Landon(5)  33,407    *      
Michael R. Merson(6)  34,215    *      
Gregory Pusey(7)  288,766   3.0     
Mark J. Ratain(8)  33,263    *      
David E. Welch(9)  80,000    *      
Jeffrey G. McGonegal(10)  159,731   1.6     
Erik S. Miller(11)  13,333    *      
All Officers and Directors as a Group (11 persons)(12)  1,013,642   9.7     
Perkins Capital Management, Inc.
730 Lake St. E.
Wayzata, MN 55391(13)
  1,659,299   17.2     
Sabby Management, Inc.
10 Mountainview Road, Suite 205
Upper Saddle River, NJ 07458(14)
  776,008   8.1     
The Peierls Foundation, Inc.
c/o U.S. Trust Company of N.Y.
114 West 47th Street
New York, NY 10036(15)
  948,088   9.8     
  
Name and Address Number of Shares Percent
Stephen T. Lundy(1)  28,670   * 
Gail S. Schoettler(2)  42,169   * 
Susan A. Evans(3)  13,000   * 
Daryl J. Faulkner(4)  34,168   * 
John H. Landon(5)  20,235   * 
David E. Welch(6)  28,002   * 
Stephen A. Williams        
Donald R. Hurd(7)  41,666   * 
Jeffrey G. McGonegal(8)  39,404   * 
All Officers and Directors as a Group (9 persons)(9)  247,314   2.5
Sophrosyne Capital, LLC
156 E. 36th Street
2 Sniffen Court
New York, NY 10016(10)
  884,432   8.9
Perkins Capital Management, Inc.
730 Lake St. E.
Wayzata, MN 55391(11)
  717,813   7.2
The Peierls Foundation, Inc.
E. Jeffrey Peierls
Brian E. Peierls
c/o U.S. Trust Company of N.Y.
114 West 47th Street
New York, NY 10036(12)
  757,865   7.6

*Holds less than 1%
(1)Consists ofIncludes 4,000 shares directly owned. Also includes options to acquire 60,000purchase 7,057 shares at $11.40$68.40 per share, options to purchase 1,382 shares at $17.70 per share, options to purchase 3,731 shares at $20.40 per share and 6,000options to purchase 12,500 shares at $2.95$3.96 per share. Does not include options of acquire 20,000 shares at $11.40 per share which are scheduled to vest in March 2013, options to acquire 12,000 shares at $2.95 per share which are scheduled to vest equally in January 2013 and January 2014, options to acquire 80,000 shares that were granted in July 2011 at $3.40 per share which vest annually over three years commencing in July 2012 and also excludes options to acquire 75,000 shares that were granted on April 30, 2012 at $0.66 which vest as to 37,500 in October 2012 and 6,250 monthly for the six months thereafter.

61


TABLE OF CONTENTS

(2)Includes 3,000 shares directly owned. Also includes options to purchase 20,0003,334 shares at $7.35$44.10 per share, options to purchase 10,0001,667 shares at $4.25$25.50 per share, options to purchase 3,334 shares at $28.80 per share, options to purchase 1,667 shares at $48.00 per share, options to purchase 1,667 shares at $88.80 per share, options to purchase 1,667 shares at $198.90 per share, options to purchase 1,667 shares at $39.90 per share, options to purchase 1,667 shares at $66.00 per share, options to purchase 1,666 shares at $17.70 per share, options to purchase 833 shares at $4.26 per share and options to purchase 20,000 shares at $4.80$2.04 per share,share.

TABLE OF CONTENTS

(3)Includes options to purchase 10,00012,000 shares at $8.00 per share, options to purchase 10,000 shares at $14.80 per share, options to purchase 10,000 shares at $33.15 per share, options to acquire 10,000 shares at $6.65 per share, options to purchase 6,667 shares at $11.00$2.56 per share and options to purchase 5,0001,000 shares at $2.95$2.04 per share. Does not include options to purchase 3,333 shares at $11.00 per share which vest in January 2013, options to acquire 10,000 shares at $2.95 per share that were granted in January 2011 which vest in equal installments in January 2013 and January 2014, and also excludes options to acquire 15,000 shares at $.71 per share that were granted on April 2, 2012 which vest in equal installments in January 2013, January 2014 and January 2015.
(3)(4)Includes 2,000334 common shares held by the Daryl J. and Terri LL. Faulkner Family Trust. Also includes options to acquire 90,000purchase 4,167 shares at $8.45$66.00 per share, and 16,667options to purchase 1,111 shares at $11.00$17.70 per share. Does not includeshares, options to acquire 8,333purchase 555 shares at $11.00$4.26 per share which are scheduled to vest in January 2012,shares, and options to acquire 8,667 shares that were granted in January 2011 at $2.95 per share which are scheduled to vest in equal installments in January 2013 and January 2014, and also excludes options to acquire 10,000purchase 13,000 shares at $.71$2.04 per share that were granted on April 2, 2012 which vest in equal installments in January 2013, January 2014 and January 2015.share.
(4)(5)Includes 1,800options to purchase 2,235 shares at $177.90 per share, options to purchase 1,667 shares at $39.90 per share, options to purchase 1,667 shares at $66.00 per share, options to purchase 1,111 shares at $17.70 per shares, options to purchase 555 shares at $4.26 per share, and options to purchase 13,000 shares at $2.04 per share.
(6)Includes options to purchase 3,334 shares at $22.80 per share, options to purchase 1,667 shares at $24.00 per share, options to purchase 1,667 shares at $48.00 per share, options to purchase 1,667 shares at $88.80 per share, options to purchase 1,667 shares at $198.90 per share, options to purchase 1,667 shares at $39.90 per share, options to purchase 1,667 shares at $66.00 per share, options to purchase 1,111 shares at $17.70 per shares, options to purchase 555 shares at $4.26 per share, and options to purchase 13,000 shares at $2.04 per share.
(7)Includes 15,000 shares directly and jointly owned with his wife plus 6,460 shares held solely by Dr. Hepler’s wife. Dr. Hepler disclaims ownership of the shares held solely by his wife.owned. Also includes options to purchase 20,000 shares at $7.50 per share, options to purchase 10,000 shares at $4.00 per share, options to purchase 10,000 shares at $8.00 per share, options to purchase 10,000 shares at $14.80 per share, options to purchase 10,000 shares at $33.15 per share, options to purchase 10,000 shares at $6.65 per share, options to purchase 6,667 shares at $11.00$3.42 per share and options to purchase 3,3336,666 shares at $2.95$2.05 per share. Excludes options to purchase 3,333 shares at $11.00 per share which vest in January 2013, and options to acquire 6,667 shares at $2.95 per share that were granted in January 2011 which vest in equal installments in January 2013 and January 2014, and also excludes options to acquire 10,000 shares at $.71 per share that were granted on April 2, 2012 which vest in equal installments in January 2013, January 2014 and January 2015.
(5)Includes options to acquire 13,407 shares at $29.35 per share, options to acquire 10,000 shares at $6.65 per share, options to acquire 6,667 shares at $11.00 per share and options to acquire 3,333 shares at $2.95 per share. Excludes options to purchase 3,333 shares at $11.00 per share which vest in January 2013, options to purchase 6,667 shares at $2.95 per share that were granted in January 2011 which vest in equal installments in January 2013 and January 2014, and also excludes options to acquire 10,000 shares at $.71 per share that were granted on April 2, 2012 which vest in equal installments in January 2013, January 2014 and January 2015.
(6)Includes 1,080 shares held directly. Also includes options to purchase 13,135 shares at $31.90 per share, options to acquire 10,000 shares at $6.65 per share, options to acquire 6,667 shares at $11.00 per share and also includes options to acquire 3,333 shares at $2.95 per share. Excludes options to acquire 3,333 shares at $11.00 per share which vest in January 2013, options to acquire 6,667 shares at $2.95 per share that were granted in January 2011 which vest in equal installments in January 2013 and January 2014, and also excludes options to acquire 10,000 shares at $.71 per share that were granted on April 2, 2012 which vest in equal installments in January 2013, January 2014 and January 2015.
(7)Includes 30,815 shares directly owned by Mr. Pusey. Also includes 14,789 shares held by Mr. Pusey’s wife and his wife’s IRA account; however Mr. Pusey disclaims beneficial ownership of these shares. Also includes: (i) 12,086 shares held in Mr. Pusey’s IRA account, (ii) 118,223 shares held jointly with his wife and (iii) 2,853 shares held by Cambridge Holdings Ltd. Mr. Pusey is President, a director and principal shareholder of Cambridge. Further, Mr. Pusey’s beneficial ownership includes options to acquire 20,000 shares at $6.05 per share, options to acquire 50,000 options at $4.00 per share, options to acquire 10,000 shares at $14.80 per share, options to acquire 10,000 shares at $33.15 per share, options to acquire 10,000 shares at $6.65 per share, options to acquire 6,667 shares at $11.00 per share and options to acquire 3,333 shares at $2.95 per share. Excludes options to acquire 3,333 shares at $11.00 per share which vest in January 2013, options to acquire 6,667 shares at $2.95 per share that were granted in January 2011 which vest in equal installments in January 2013 and January 2014 and also excludes options to acquire 40,000 shares that were granted on April 30, 2012 at $0.66 which vest as to 20,000 in October 2012 and 3,333 monthly for the six months thereafter.

62


TABLE OF CONTENTS

(8)Includes options to acquire 13,263 shares at $30.65 per share, options to acquire 10,000 shares at $6.65 per share, options to acquire 6,667 shares at $11.00 per share and also includes options to acquire 3,333 shares at $2.95 per share. Excludes, options to purchase 3,333 shares at $11.00 per share which vest in January 2013, options to acquire 6,667 shares at $2.95 per share that were granted in January 2011 which vest in equal installments in January 2013 and January 2014, and also excludes options to acquire 10,000 shares at $.71 per share that were granted on April 2, 2012 which vest in equal installments in January 2013, January 2014 and January 2015.
(9)Includes options to acquire 20,000 shares at $3.80 per share, options to acquire 10,000 shares at $4.00 per share, options to acquire 10,000 shares at $8.00 per share, options to purchase 10,000 shares at $14.80 per share, options to purchase 10,000 shares at $33.15 per share, options to purchase 10,000 shares at $6.65 per share, options to acquire 6,667 shares at $11.00 per share and also includes options to acquire 3,333 shares at $2.95 per share. Excludes options to purchase 3,333 shares at $11.00 per share which vest in January 2013, options to acquire 6,667 shares at $2.95 per share that were granted in January 2011 which vest in equal installments in January 2013 and January 2014, and also excludes options to acquire 10,000 shares at $.71 per share that were granted on April 2, 2012 which vest in equal installments in January 2013, January 2014 and January 2015.
(10)Includes 48,43113,072 shares held directly and 30050 shares owned by his daughter; however Mr. McGonegal disclaims beneficial ownership of the shares owned by his daughter. Also includes 3,000500 shares held in Mr. McGonegal’s IRA account. Also includes options to purchase 12,0002,000 shares at $7.35, options to acquire 28,000 shares at $6.05$44.10 per share, options to acquire 20,0004,668 shares at $3.75$36.30 per share, options to purchase 10,0003,334 shares at $4.00$22.50 per share, options to purchase 10,0001,667 shares at $14.80$24.00 per share, options to purchase 8,0001,667 shares at $33.15$88.80 per share, options to acquire 10,000purchase 1,334 shares at $6.65$198.90 per share, options to purchase 1,667 shares at $39.90 per share, options to purchase 1,667 shares at $66.00 per share, options to purchase 1,111 shares at $17.70 per share, and options to purchase 6,667 shares at $11.00$3.96 per share and also includes options to acquire 3,333 shares at $2.95 per share. Excludes options to purchase 3,333 shares at $11.00 per share which vest
(9)Includes the information in January 2013, options to acquire 6,667 shares at $2.95 per share that were granted in January 2011 which vest in equal installments in January 2013 and January 2014 and also excludes options to acquire 40,000 shares that were granted on April 30, 2012 at $0.66 which vestfootnotes (1) through (8).
(10)Information is as to 20,000 in Octoberof November 26, 2012, and 3,333 monthly foris based upon holdings as reported on Schedule 13G filed by the six months thereafter.shareholder on November 27, 2012. Sophrosyne Capital, LLC, has voting power and dispositive power over 884,432 shares of our common stock.
(11)Includes options to acquire 13,333 shares at $3.25 per share. Excludes options to purchase 26,667 shares at $3.25 per share that were granted in January 2011 which vest in equal installments in January 2013 and January 2014 and also excludes options to acquire 15,000 shares that were granted on April 30, 2012 at $0.66 which vest as to 7,500 in October 2012 and 1,250 monthly for the six months thereafter. On May 11, 2012, Mr. Miller resigned from the Company.
(12)Includes footnotes (1) through (11).
(13)Information is based upon holdings as of MarchDecember 31, 2012 as reported on Schedule 13G13G/A filed on April 9, 2012.February 1, 2013. Perkins Capital Management, Inc., an investment advisor, has voting power over 1,191,759626,406 shares and dispositive power over 1,659,299 shares.717,813 shares of our common stock.
(14)(12)Information is based upon holdings as of December 31, 2011June 20, 2012 as reported on Schedule 13G13G/A jointly filed on January 9, 2012. Sabby Volatility Warrant Master Fund, Ltd. (“Sabby Fund”), Sabby Management, LLC (“Sabby”) and Hal Mintz (“Mintz”) each beneficially own 776,008 shares. Sabby and Mintz do not directly own any shares, but each indirectly owns 776,008 shares. Sabby serves as the investment manager of Sabby Fund, which directly holds the shares. Mintz is the manager of Sabby.
(15)Information based on representations made by representatives of theThe Peierls Foundation, Inc. to, E. Jeffrey Peierls and Brian Peierls on July 5, 2012. Consists of 713,095 shares of our common stock and 44,740 shares of our common stock which may be purchased upon exercise of warrants. The warrants may not be exercised if such exercise would result in the Company in April 2012.holder and affiliates owning greater than 9.99% of our common stock.


63


 

TABLE OF CONTENTS

DESCRIPTION OF SECURITIES

Common Stock

Our authorized capital stock consists of 30,000,000 shares of common stock, no par value per share. On April 17, 2013, the Board of Directors approved an amendment to our Articles of Incorporation, as amended, to increase the total number of shares of common stock we are authorized to issue from 30,000,000 to 60,000,000, with such amendment being subject to shareholder approval. The amendment is being submitted to shareholders for approval at the annual meeting of shareholders on June 11, 2013.

As of May 24, 2012,6, 2013, we had 1,609,7209,954,380 outstanding shares of common stock adjusted to reflect the anticipated 1-for-6 reverse stock split.stock.

As of May 24, 2012,March 31, 2013, we had outstanding stock options to purchase 238,4811,226,899 shares of common stock issuable upon the exercise of outstanding options granted under our stock option plans at prices ranging from $3.96 to $261.60, as adjusted for the anticipated 1-for-6 reverse stock split. Asa weighted average exercise price of May 24, 2012, we had outstanding non-qualified options and warrants to purchase 296,889$8.94 per share, 597,004 shares of common stock issuable upon exercise of options granted outside of our stock option plans and warrants at ana weighted average exercise price of $7.91$4.87 per share, and 260,306 shares of common stock as adjusted to reflect the anticipated 1-for-6 reverseavailable for future issuance under our stock split.option plans.

Holders of common stock are entitled to one vote for each share held on all matters submitted to a vote of shareholders, except that in the election of directors each shareholder shall have as many votes for each sharesshare held by him, her or it as there are directors to be elected and for whose election the shareholder has a right to vote. Cumulative voting is not permitted. Generally, all matters to be voted on by shareholders must be approved by a majority, or, in the case of the election of directors, by a plurality, of the votes cast at a meeting at which a quorum is present.

Holders of outstanding shares of our common stock are entitled to those dividends declared by the Board of Directors out of legally available funds, and, in the event of our liquidation, dissolution or winding up of our affairs, holders are entitled to receive ratably our net assets available to the shareholders. Holders of our outstanding common stock have no preemptive, conversion or redemption rights. All of the issued and outstanding shares of our common stock are, and all unissued shares of our common stock, when offered and sold will be, duly authorized, validly issued, fully paid and nonassessable. To the extent that additional shares of our common stock may be issued in the future, the relative interests of the then existing shareholders may be diluted.

Our authorized but unissued shares of common stock are available for future issuances without shareholder approval and could be utilized for a variety of corporate purposes, including future offerings to raise additional capital, corporate acquisitions and employee benefit plans. The existence of authorized but unissued and unreserved common stock could render more difficult or discourage an attempt to obtain control of us by means of a proxy contest, tender offer, merger or otherwise.

Our Board of Directors approved an amendment as of March 21, 2012, to our Articles of Incorporation as amended, that would permit a reverse split of our issued and outstanding common stock. The amendment was approved by our shareholders at our Annual Meeting held on May 22, 2012, giving our Board of Directors the authority to effect a reverse split of our issued and outstanding common stock at a ratio in the range of between 1-for-2 and 1-for-6. For purposes of disclosure, we have assumed a 1-for-6 reverse stock split immediately prior to the date of this prospectus.

Underwriters’ Warrants

We are registering the warrants we have agreed to sell to the representative of the underwriters in this offering to purchase up to a total of      shares of common stock (5% of the shares sold in this offering). A complete description of those warrants is included in the section of this prospectus titled “Underwriting — Underwriters’ Warrants.”

Transfer Agent

The transfer agent for our common stock is Corporate Stock Transfer, Inc., Denver, CO.Colorado.

Listing

The shares of our common stock are currently listed on the NASDAQ Capital Market under the symbol “APPY.”


64


 

TABLE OF CONTENTS

MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS

General

The following is a discussion of the material U.S. federal income tax consequences of the acquisition, ownership, and disposition of our common stock by a non-U.S. holder, as defined below, that acquires our common stock pursuant to this offering. This discussion assumes that a non-U.S. holder will hold our common stock issued pursuant to this offering as a capital asset within the meaning of Section 1221 of the Code. This discussion does not address all aspects of U.S. federal income taxation that may be relevant to a particular investor in light of the investor’s individual circumstances. In addition, this discussion does not address (i) U.S. federal non-income tax laws, such as gift or estate tax laws, (ii) state, local or non-U.S. tax consequences, (iii) the special tax rules that may apply to certain investors, including, without limitation, banks, insurance companies, financial institutions, controlled foreign corporations, passive foreign investment companies, broker-dealers, grantor trusts, personal holding companies, taxpayers who have elected mark-to-market accounting, tax-exempt entities, regulated investment companies, real estate investment trusts, a partnership or other entity or arrangement classified as a partnership for United States federal income tax purposes or other pass-through entities, or an investor in such entities or arrangements, or U.S. expatriates or former long-term residents of the United States, (iv) the special tax rules that may apply to an investor that acquires, holds, or disposes of our common stock as part of a straddle, hedge, constructive sale, conversion or other integrated transaction, or (v) the impact, if any, of the alternative minimum tax.

This discussion is based on current provisions of the Code, applicable U.S. Treasury Regulations promulgated thereunder, judicial opinions, and published rulings of the Internal Revenue Service, or the IRS, all as in effect on the date of this prospectus and all of which are subject to differing interpretations or change, possibly with retroactive effect. We have not sought, and will not seek, any ruling from the IRS or any opinion of counsel with respect to the tax consequences discussed herein, and there can be no assurance that the IRS will not take a position contrary to the tax consequences discussed below or that any position taken by the IRS would not be sustained.

As used in this discussion, the term “U.S. person” means a person that is, for U.S. federal income tax purposes, (i) a citizen or individual resident of the United States, (ii) a corporation (or other entity taxed as a corporation) created or organized (or treated as created or organized) in the United States or under the laws of the United States or any state thereof or the District of Columbia, (iii) an estate the income of which is subject to U.S. federal income taxation regardless of its source, or (iv) a trust if (A) a court within the United States is able to exercise primary supervision over the administration of the trust and one or more U.S. persons have the authority to control all substantial decisions of the trust, or (B) it has in effect a valid election under applicable U.S. Treasury Regulations to be treated as a U.S. person. As used in this discussion, the term “non-U.S. holder” means a beneficial owner of our common stock (other than a partnership or other entity treated as a partnership or as a disregarded entity for U.S. federal income tax purposes) that is not a U.S. person.

The tax treatment of a partnership and each partner thereof will generally depend upon the status and activities of the partnership and such partner. A holder that is treated as a partnership for U.S. federal income tax purposes or a partner in such partnership should consult its own tax advisor regarding the U.S. federal income tax consequences applicable to it and its partners of the acquisition, ownership and disposition of our common stock.

THIS DISCUSSION IS ONLY A SUMMARY OF MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS OF THE ACQUISITION, OWNERSHIP AND DISPOSITION OF OUR COMMON STOCK. IT IS NOT TAX ADVICE. EACH PROSPECTIVE INVESTOR SHOULD CONSULT ITS OWN TAX ADVISOR WITH RESPECT TO THE PARTICULAR TAX CONSEQUENCES OF THE ACQUISITION, OWNERSHIP AND DISPOSITION OF OUR COMMON STOCK, INCLUDING THE APPLICABILITY AND EFFECT OF ANY STATE, LOCAL, AND NON-U.S. TAX LAWS, AS WELL AS U.S. FEDERAL ESTATE AND GIFT TAX LAWS, AND ANY APPLICABLE TAX TREATY.


TABLE OF CONTENTS

Income Tax Consequences of an Investment in Common Stock

Distributions on Common Stock

As discussed under “Dividend Policy,” we do not anticipate paying dividends. If we pay cash or distribute property to holders of shares of common stock, such distributions generally will constitute dividends for U.S. federal income tax purposes to the extent paid from our current or accumulated earnings and profits, as determined under U.S. federal income tax principles. Distributions in excess of current and accumulated earnings and profits will constitute a return of capital that will be applied against and reduce (but not below zero) the holder’s adjusted tax basis in our common stock. Any remaining excess will be treated as gain from the sale or exchange of the common stock and will be treated as described under “— Gain or Loss on Sale, Exchange or Other Taxable Disposition of Common Stock” below.

Dividends paid to a non-U.S. holder that are not effectively connected with the non-U.S. holder’s conduct of a trade or business in the United States generally will be subject to withholding of U.S. federal income tax at a rate of 30% or such lower rate as may be specified by an applicable income tax treaty. A non-U.S. holder that wishes to claim the benefit of an applicable tax treaty withholding rate generally will be required to (i) complete IRS Form W-8BEN (or other applicable form) and certify under penalties of perjury that such holder is not a U.S. person and is eligible for the benefits of the applicable tax treaty or (ii) if our common stock is held through certain foreign intermediaries, satisfy the relevant certification requirements of applicable U.S. Treasury Regulations. These forms may need to be periodically updated.

A non-U.S. holder eligible for a reduced rate of withholding of U.S. federal income tax pursuant to an income tax treaty may obtain a refund of any excess amounts withheld by timely filing an appropriate claim for refund with the IRS. Non-U.S. holders should consult their own tax advisors regarding their entitlement to benefits under an applicable income tax treaty and the manner of claiming the benefits of such treaty (including, without limitation, the need to obtain a U.S. taxpayer identification number).

Dividends that are effectively connected with a non-U.S. holder’s conduct of a trade or business in the United States, and, if required by an applicable income tax treaty, attributable to a permanent establishment or fixed base maintained by the non-U.S. holder in the United States, are subject to U.S. federal income tax on a net income basis at the U.S. federal income tax rates generally applicable to a U.S. holder and are not subject to withholding of U.S. federal income tax, provided that the non-U.S. holder establishes an exemption from such withholding by complying with certain certification and disclosure requirements. Any such effectively connected dividends (and, if required, dividends attributable to a U.S. permanent establishment or fixed base) received by a non-U.S. holder that is treated as a foreign corporation for U.S. federal income tax purposes may be subject to an additional branch profits tax at a 30% rate, or such lower rate as may be specified by an applicable income tax treaty.

Gain or Loss on Sale, Exchange or Other Taxable Disposition of Common Stock

Any gain recognized by a non-U.S. holder on a sale or other taxable disposition of our common stock generally will not be subject to U.S. federal income tax, unless:

(i)the gain is effectively connected with a trade or business of the non-U.S. holder in the United States (and, if required by an applicable income tax treaty, is attributable to a U.S. permanent establishment or fixed base of the non-U.S. holder),
(ii)the non-U.S. holder is an individual who is present in the United States for 183 days or more in the taxable year of that disposition, and certain other conditions are met, or
(iii)we are or have been a United States real property holding corporation, or a USRPHC, for U.S. federal income tax purposes at any time during the shorter of the five-year period ending on the date of disposition or the period that the non-U.S. holder held the common stock, and, in the case where the shares of our common stock are regularly traded on an established securities market, the non-U.S. holder holds or held (at any time during the shorter of the five-year period ending on the date of disposition or the non-U.S. holder’s holding period) more than 5% of our common stock. A corporation generally is a USRPHC if the fair market value of its U.S. real property interests equals or exceeds 50% of the sum of the fair market value of its worldwide real property interests plus its

TABLE OF CONTENTS

other assets used or held for use in a trade or business. We believe that we currently are a USRPHC, and we expect to remain a USRPHC.

Any gain recognized by a non-U.S. holder that is described in clause (i) or (iii) of the preceding paragraph generally will be subject to tax at the U.S. federal income tax rates generally applicable to a U.S. person and be required to file a U.S. tax return. Such non-U.S. holders are urged to consult their tax advisors regarding the possible application of these rules. Any gain of a corporate non-U.S. holder that is described in clause (i) above may also be subject to an additional branch profits tax at a 30% rate, or such lower rate as may be specified by an applicable income tax treaty. An individual non-U.S. holder that is described in clause (ii) of such paragraph generally will be subject to a flat 30% tax (or a lower applicable tax treaty rate) on the U.S. source capital gain derived from the disposition, which may be offset by U.S. source capital losses during the taxable year of the disposition.

Information Reporting and Backup Withholding

We generally must report annually to the IRS and to each non-U.S. holder of our common stock the amount of dividends paid to such holder on our common stock and the tax, if any, withheld with respect to those dividends. Copies of the information returns reporting those dividends and withholding may also be made available to the tax authorities in the country in which the non-U.S. holder is a resident under the provisions of an applicable income tax treaty or agreement. Information reporting also is generally required with respect to the proceeds from sales and other dispositions of our common stock to or through the U.S. office (and in certain cases, the foreign office) of a broker.

Under some circumstances, U.S. Treasury Regulations require backup withholding of U.S. federal income tax, currently at a rate of 28%, on reportable payments with respect to our common stock. A non-U.S. holder generally may eliminate the requirement for information reporting (other than in respect to dividends, as described above) and backup withholding by providing certification of its foreign status, under penalties of perjury, on a duly executed applicable IRS Form W-8 or by otherwise establishing an exemption. Notwithstanding the foregoing, backup withholding and information reporting may apply if either we or our paying agent has actual knowledge, or reason to know, that a holder is a U.S. person.

Backup withholding is not a tax. Rather, the amount of any backup withholding will be allowed as a credit against a non-U.S. holder’s U.S. federal income tax liability, if any, and may entitle such non-U.S. holder to a refund, provided that certain required information is timely furnished to the IRS. Non-U.S. holders should consult their own tax advisors regarding the application of backup withholding and the availability of and procedure for obtaining an exemption from backup withholding in their particular circumstances.


TABLE OF CONTENTS

UNDERWRITING

Aegis Capital Corp.We are offering the shares of our common stock described in this prospectus in an underwritten offering in which Piper Jaffray & Co., or the underwriter, is acting as the representative of the underwriters of the offering. We have entered into an underwriting agreement dated     , 2012 with the representative.sole underwriter. Subject to the terms and conditions of the underwriting agreement, we have agreed to sell to eachthe underwriter named below and each underwriter named below has severally agreed to purchase all of the shares of common stock being offered pursuant to this prospectus.

The underwriter is committed to purchase and pay for all of the shares if any are purchased, other than those shares covered by the over-allotment option described below. The underwriter proposes to offer the common stock directly to the public at the public offering price less the underwriting discounts and commissions set forth on the cover page of this prospectus the number of shares of common stock listed next to its name in the following table:

NameNumber of
Shares
Aegis Capital Corp.
Total

The underwriting agreement provides that the obligations of the underwriters are subjectand to certain conditions precedent and that the underwriters have agreed, severally and not jointly, to purchase all of the shares of common stock sold under the underwriting agreement if any of these shares are purchased. If an underwriter defaults, the underwriting agreement provides that the purchase commitments of the non-defaulting underwriters may be increased or the underwriting agreement may be terminated.

We have agreed to indemnify the underwriters against specified liabilities, including liabilities under the Securities Act, and to contribute to payments the underwriters may be required to make in respect thereof.

The underwriters are offering our common stock, subject to prior sale, when, as and if issued to and accepted by them, subject to approval of legal matters by their counsel and other conditions specified in the underwriting agreement. The underwriters reserve the right to withdraw, cancel or modify offers to the public and to reject orders in whole or in part.

The underwriters propose to offer the shares of our common stock offered by us to the public at the public offering price set forth on the cover of this prospectus. In addition, the underwriters may offer some of the shares of our common stock to other securities dealers at suchthat price less a concession of $     per share. The underwriters may also allow, and such dealers may re-allow, a concession not in excess of $     per shareshare. After this offering, the underwriter may change the offering price and other selling terms.

We have granted the underwriter an option to other dealers. Afterbuy up to an additional      shares of our common stock to cover over-allotments. The underwriter may exercise this option at any time and from time to time during the public offering30-day period from the date of this prospectus. If any additional shares of common stock are purchased, the underwriter will offer the additional shares on the same terms as those on which the shares are being offered.

The underwriting discount is equal to the public offering price per share and other selling terms may be changedof common stock less the amount paid by the underwriters.

Commissions and Discounts

underwriter to us per share of common stock. The following table shows the per share and total underwriting discounts and commissions that we arediscount to paybe paid to the underwritersunderwriter in connection with this offering.offering, assuming both no exercise and full exercise of the over-allotment option.

   
 Per Share Total Withoutwith
Over-Allotment
OptionNo Exercise
 Total With
Over-Allotment
Option Exercise
Public offering pricePaid by us $  $  $
Underwriting discount (7%)$$$
Non-accountable expense allowance (1%)$$$
Proceeds, before expenses, to us$$$ 

We have paid an expense depositestimate expenses payable by us in connection with this offering of $25,000common stock, other than the underwriting discounts referred to the representative whichabove, will be applied againstapproximately $       . This estimate includes $150,000 of fees and expenses of the non-accountable expenses thatunderwriter. The underwriter has not received and will not receive from us any other item of compensation or expense in connection with this offering considered by the Financial Industry Regulatory Authority to be underwriting compensation under its rule of fair price. The underwriting discount was determined through an arms’ length negotiation between us and the underwriter. Aegis Capital Corp. is acting as a financial advisor in connection with this offering and will be entitled to a financial advisory fee of $50,000, which amount will be paid by us to the underwriters in connection with this offering.

We estimate that the total expensesunderwriter out of the offering, including registration, filing and listing fees, printing fees and legal and accounting expenses, but excluding the underwriting discount, will be approximately $450,000.commission.

65


TABLE OF CONTENTS

Over-allotment Option

We have granted a 45-day option to the underwriters to purchase up to an additional shares of common stock (15% of common stock sold in this offering) to cover over-allotments, if any, at the same price as the initial shares offered. If the underwriters fully exercise their over-allotment option, the total public offering price, underwriting discounts and commissions, and net proceeds (before expenses) to us will be $       , $      and $       , respectively.

Underwriters’ Warrants

We have agreed to issue toindemnify the representative warrants to purchase up to a total of      shares of common stock (5% of the shares sold in this offering, excluding the over-allotment option). The shares issuable upon exercise of these warrants are identical to those offered by this prospectus. The warrants are exercisable at per share price equal to 125% of the public offering price per share in this offering commencing on a date which is one year from the effective date of the offering under this prospectus and expiring on a date which is no more than five years from the effective date of the offering in compliance with FINRA Rule 5110(f)(2)(H)(i). The warrants have been deemed compensation by FINRA and are, therefore, subject to a 180-day lock -up pursuant to Rule 5110(g)(1) of FINRA. The underwriters (or permitted assigneesunderwriter against certain liabilities, including civil liabilities under the Rule) will not sell, transfer, assign, pledgeSecurities Act, or hypothecate these warrants orto contribute to payments that the securities underlying these warrants, nor will it engage in any hedging, short sale, derivative, put or call transaction that would result in the effective economic disposition of these warrants or the underlying securities for a period of 180 days after the effective date. In addition, the warrants provide for registration rights upon request, in certain cases. The demand registration right provided will not be greater than five years from the effective date of the offering in compliance with FINRA Rule 5110(f)(2)(H)(iv). The piggyback registration right provided will not be greater than seven years from the effective date of the offering in compliance with FINRA Rule 5110(f)(2)(H)(v). We will bear all fees and expenses attendant to registering the securities issuable on exercise of the warrants, other than underwriting commissions incurred and payable by the holders. The exercise price and number of shares issuable upon exercise of the warrantsunderwriter may be adjustedrequired to make in certain circumstances including in the eventrespect of a stock dividend, extraordinary cash dividend or our recapitalization, reorganization, merger or consolidation. However, the warrant exercise price or underlying shares will not be adjusted for issuancesthose liabilities.

We and each of common stock at a price below the warrant exercise price.

Lock-ups

We, our directors and executive officers are subject to lock-up agreements that prohibit us and one of our stockholders have entered into lock up agreements withthem from offering for sale, pledging, announcing the representative prior to the commencement of this offering pursuant to which each of these persons or entities, for a period of three months from the effective date of this offering without the prior written consent of the representative, agree not to (1) offer, pledge, sell, contractintention to sell, grant, lend,selling, contracting to sell, granting any option, right or warrant to purchase, or otherwise transfertransferring or disposedisposing of, directly or indirectly, any shares of our common stock or any securities convertible into or exercisable or exchangeable for shares of our common stock or (2) enter into any swap or other arrangement that transfers to another, in whole or in part, anyfor a period of at least 90 days following the date of this prospectus without the prior written consent of the economic consequencesunderwriter. The lock-up agreements do not prohibit our directors and executive officers from transferring shares of ownershipour common stock for bona fide estate or tax planning purposes, subject to certain requirements, including that the transferee be subject to the same lock-up terms. The lock-up provisions also do not prevent us from selling shares to the underwriter pursuant to the underwriting agreement, and do not prevent us from granting options to acquire securities under our existing stock option plans or issuing shares upon the exercise or conversion of securities outstanding on the date of this prospectus.

The 90-day lock-up period in all of the common stock, whether any such transaction described in clause (1) or (2) abovelock-up agreements is subject to be settled by delivery of common stock or such other securities, in cash or otherwise, or (3) make any demand for or exercise any right with respect to the registration of any shares of common stock or any security convertible into or exercisable or exchangeable for common stock, or (4) publicly disclose the intention to make any offer, sale, pledge or disposition, or to enter into any transaction, swap, hedge or other arrangement relating to any of the common stock. Notwithstanding these limitations, these common shares may be transferred by gift, will or intestate succession, or by judicial decree under certain limited circumstances.

The lock-up period described in the preceding paragraphs will be automatically extended if: (1)extension if (i) during the last 17 days of the restrictedlock-up period we issue an earnings release or announce material news or a material event;event relating to us occurs or (2)(ii) prior to the expiration of the lock-up period, we announce that we will release earnings results during the 16-day period beginning on the last day of the lock-up period, in which case the restrictions describedimposed in the preceding paragraph willthese lock-up agreements shall continue to apply until the expiration of the 18-day period beginning on the dateissuance of the earnings release.release or the occurrence of the material news or material event. The restrictions in the lock-up agreements may be waived at any time in the sole discretion of the underwriter.


66


 

TABLE OF CONTENTS

AnyTo facilitate the offering, the underwriter may engage in transactions that stabilize, maintain or otherwise affect the price of the securities subject to the lock-up agreement may be released in whole or part from the terms thereof only upon the approval of the representative; provided, however, that we must announce any such release through a major news serviceour common stock during and such release will only be effective two business days after the publication date of such press release.

Right of First Refusal

If at least $15,000,000offering. Specifically, the underwriter may over-allot or otherwise create a short position in the common stock for their own account by selling more shares of common stock arethan we have sold in this offering, we will grantto the representative, forunderwriter. Short sales involve the sale by the underwriter of a periodgreater number of 12 months aftershares than the closing of this offering, a right of first refusalunderwriter is required to act as,purchase in the Company’s discretion, as leadoffering. The underwriter may close out any short position by either exercising their option to purchase additional shares or minimally as co-manager with at least 50%purchasing shares in the open market.

In addition, the underwriter may stabilize or maintain the price of the economics,common stock by bidding for or purchasing shares of common stock in the caseopen market and may impose penalty bids. If penalty bids are imposed, selling concessions allowed to syndicate members or other broker-dealers participating in the offering are reclaimed if shares of common stock previously distributed in the offering are repurchased, whether in connection with stabilization transactions or otherwise. The effect of these transactions may be to stabilize or maintain the market price of the common stock at a level above that which might otherwise prevail in the open market. The imposition of a three-underwriter or placement agent transaction, 33%penalty bid may also affect the price of the economics.common stock to the extent that it discourages resales of the common stock. The magnitude or effect of any stabilization or other transactions is uncertain. These transactions may be effected on the NASDAQ Capital Market or otherwise and, if commenced, may be discontinued at any time.

Electronic Offer, SaleThe underwriter may also engage in passive market making transactions in our common stock. Passive market making consists of displaying bids on the NASDAQ Capital Market limited by the prices of independent market makers and Distributioneffecting purchases limited by those prices in response to order flow. Rule 103 of SharesRegulation M promulgated by the SEC limits the amount of net purchases that each passive market maker may make and the displayed size of each bid. Passive market making may stabilize the market price of the common stock at a level above that which might otherwise prevail in the open market and, if commenced, may be discontinued at any time.

AThis prospectus may be available in electronic format may be made available on the websites or other online resources maintained by the underwritersunderwriter or one or more ofits affiliates and the selling group members, if any, participating in this offering and one or more of the underwriters participating in this offeringunderwriter may distribute prospectusesthis prospectus electronically. The representative may agree to allocate a number of shares to the underwriters and selling group members for sale to their online brokerage account holders. Internet distributions will be allocated by the underwriters and selling group members that will make internet distributions on the same basis as other allocations. Other than thethis prospectus in electronic format, the information on thesesuch websites and any information contained in any other website maintained by the underwriter or any of its affiliates is not part of nor incorporated by reference into, this prospectus or the registration statement of which this prospectus form a part, has not been approved or endorsed by us or anythe underwriter in its capacity as underwriter and should not be relied upon by investors.

Stabilization

In connection with this offering, the underwriters may engage in stabilizing transactions, over-allotment transactions, syndicate-covering transactions, penalty bidsThe underwriter and purchases to cover positions created by short sales.

Stabilizing transactions permit bids to purchase shares so long as the stabilizing bids do not exceed a specified maximum, and are engaged in for the purpose of preventing or retarding a decline in the market price of the shares while the offering is in progress.
Over-allotment transactions involve sales by the underwriters of shares in excess of the number of shares the underwriters are obligated to purchase. This creates a syndicate short position which may be either a covered short position or a naked short position. In a covered short position, the number of shares over-allotted by the underwriters is not greater than the number of shares that they may purchase in the over-allotment option. In a naked short position, the number of shares involved is greater than the number of shares in the over-allotment option. The underwriters may close out any short position by exercising its over-allotment option and/or purchasing shares in the open market.
Syndicate covering transactions involve purchases of shares in the open market after the distribution has been completed in order to cover syndicate short positions. In determining the source of shares to close out the short position, the underwriters will consider, among other things, the price of shares available for purchase in the open market as compared with the price at which it may purchase shares through exercise of the over-allotment option. If the underwriters sell more shares than could be covered by exercise of the over-allotment option and, therefore, have a naked short position, the position can be closed out only by buying shares in the open market. A naked short position is more likely to be created if the underwriters are concerned that after pricing there could be downward pressure on the price of the shares in the open market that could adversely affect investors who purchase in the offering.
Penalty bids permit the representative to reclaim a selling concession from a syndicate member when the shares originally sold by that syndicate member are purchased in stabilizing or syndicate covering transactions to cover syndicate short positions.

These stabilizing transactions, syndicate covering transactions and penalty bids may have the effect of raising or maintaining the market price of our shares or common stock or preventing or retarding a decline in the market price of our shares or common stock. As a result, the price of our common stock in the open market

67


TABLE OF CONTENTS

may be higher than it would otherwise be in the absence of these transactions. Neither we nor the underwriters make any representation or prediction as to the effect that the transactions described above may have on the price of our common stock. These transactions may be effected on The NASDAQ Capital Market, in the over-the-counter market or otherwise and, if commenced, may be discontinued at any time.

Passive market making

In connection with this offering, the underwriters and selling group members may engage in passive market making transactions in our common stock on The NASDAQ Capital Market in accordance with Rule 103 of Regulation M under the Exchange Act, during a period before the commencement of offers or sales of the shares and extending through the completion of the distribution. A passive market maker must display its bid at a price not in excess of the highest independent bid of that security. However, if all independent bids are lowered below the passive market maker’s bid, then that bid must then be lowered when specified purchase limits are exceeded.

Indemnification

The underwriting agreement provides for indemnification between us and the underwriters against specified liabilities, including liabilities under the Securities Act, and for contribution by us and the underwriters to payments that may be required to be made with respect to those liabilities. We have been advised that, in the opinion of the SEC, indemnification for liabilities under the Securities Act is against public policy as expressed in the Securities Act, and is therefore, unenforceable.

The foregoing does not purport to be a complete statement of the terms and conditions of the underwriting agreement. Reference is made to a copy of the underwriting agreement, which is on file as an exhibit to the registration statement or an amendment to the registration statement, of which this prospectus forms a part.

Other Relationships

The underwriters and their affiliates have provided in the past to us and our affiliates and may provide from time to time in the future provide, variouscertain commercial banking, financial advisory, investment banking, commercial banking and other financial services for us and oursuch affiliates in the ordinary course of their business, for which they have received, and may in the future receive, customary fees; however, except as disclosed in this prospectus, we have no present arrangements with the underwriters for any further services.

Other Terms

Certain of the underwriters and their affiliates have provided, and may in the future provide, various investment banking, commercial banking and other financial services for us and our affiliates for which they have received, and may in the future receive customary fees however, except as disclosed in this prospectus, we have no present arrangements with any of the underwriters for any further services.

Fromand commissions. In addition, from time to time, the underwritersunderwriter and theirits affiliates may effect transactions for their own account or the account of customers, and hold on behalf of themselves or their customers, long or short positions in our debt or equity securities or loans, and may do so in the future.

Selling Restrictions

We have also agreed to pay the underwriters expenses relating to the offering, including (a) all fees, expenses and disbursements relating to background checks of our officers and directors in an amount not to exceed $1,000 per individual and an aggregate amount of $10,000; (b) all fees incurred in clearing this offering with FINRA, (c) up to $15,000 for the underwriters’ expenses (including fees of counsel) incurred relating to registration or qualification of the shares under the “blue sky” securities laws, (d) up to $20,000 of accountable “road show” expenses, and (e) up to $20,000 for the underwriters use of Ipreo’s book-building, prospectus tracking and compliance software for this offering. We have paid an advance of $25,000 to the representative, which will be applied against the non-accountable expense allowance (including an advance for the fees and expenses of the underwriters’ counsel). The total of any advanced payments will be refundable to the extent not actually incurred in compliance with FINRA Rule 5110(f)(2)(C).

68


TABLE OF CONTENTS

Offer Restrictions OutsideSales outside the United States

Other thanStates.  No action has been taken in any jurisdiction, except in the United States, no action has been taken by us or the underwriters that would permit a public offering of the common shares, or the possession, circulation or distribution of common stock offered by this prospectus or any other material relating to us or the common shares in any jurisdiction where action for that purpose is required. TheAccordingly, the common shares offered by this prospectus may not be offered or sold, directly or indirectly, nor mayand neither this prospectus ornor any other offering material or advertisements in connection with the offer and sale of any suchcommon shares may be distributed or published, in or from any country or jurisdiction except under circumstances that will result in compliance with theany applicable rules and regulations of thatany such country or jurisdiction. Persons into whose possession this prospectus comes are advised to inform themselves about and to observe any restrictions relating to the offering and the distribution of this prospectus. This prospectus does not constitute an offerThe underwriter may arrange to sell or a solicitation of an offer to buy anycommon shares offered by this prospectushereby in any jurisdiction in which such an offercertain jurisdictions outside the United States, either directly or a solicitation is unlawful.

Australia

This prospectus is not a disclosure document under Chapter 6D of the Australian Corporations Act, has not been lodged with the Australian Securities and Investments Commission and does not purport to include the information required of a disclosure document under Chapter 6D of the Australian Corporations Act. Accordingly, (i) the offer of the securities under this prospectus is only made to persons to whomthrough affiliates, where it is lawfulpermitted to offer the securities without disclosure under Chapter 6D of the Australian Corporations Act under one or more exemptions set outdo so.

Notice to prospective investors in section 708 of the Australian Corporations Act, (ii) this prospectus is made available in Australia only to those persons as set forth in clause (i) above, and (iii) the offeree must be sent a notice stating in substance that by accepting this offer, the offeree represents that the offeree is such a person as set forth in clause (i) above, and, unless permitted under the Australian Corporations Act, agrees not to sell or offer for sale within Australia any of the securities sold to the offeree within 12 months after its transfer to the offeree under this prospectus.

China

The information in this document does not constitute a public offer of the securities, whether by way of sale or subscription, in the People’s Republic of China (excluding, for purposes of this paragraph, Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan). The securities may not be offered or sold directly or indirectly in the PRC to legal or natural persons other than directly to “qualified domestic institutional investors.”

European Economic Area — Belgium, Germany, Luxembourg and Netherlands

The information in this document has been prepared on the basis that all offers of securities will be made pursuantArea.  In relation to an exemption under the Directive 2003/71/EC (“Prospectus Directive”), as implemented ineach Member StatesState of the European Economic Area (each, a “Relevantthat has implemented the Prospectus Directive, with effect from and including the date on which the Prospectus Directive is implemented in that Member State”), from the requirement to produce a prospectus for offersState, an offer of securities.

An offer to the public of securities has not been made, and may not be made to the public in a Relevantthat Member State, except pursuant to one of the following exemptions under the Prospectus Directive as implemented in that Relevant Member State:other than:

to legal entities that are authorized or regulated to operate in the financial markets or, if not so authorized or regulated, whose corporate purpose is solely to invest in securities;
(a)to any legal entity that is a qualified investor as defined in the Prospectus Directive;
to any legal entity that has two or more of (i) an average of at least 250 employees during its last fiscal year; (ii) a total balance sheet of more than €43,000,000 (as shown on its last annual unconsolidated or consolidated financial statements) and (iii) an annual net turnover of more than €50,000,000 (as shown on its last annual unconsolidated or consolidated financial statements);

TABLE OF CONTENTS

(b)to fewer than 100 or, if that Member State has implemented the relevant provision of the 2010 PD Amending Directive, 150 natural or legal persons (other than “qualified investors” as defined in the Prospectus Directive) subject to obtaining the prior consent of the representatives; or
(c)in any other circumstances that do not require the publication of a prospectus pursuant to Article 3 of the Prospectus Directive;

provided that no such offer of securities shall require us or the underwriter to publish a prospectus pursuant to Article 3 of the Prospectus Directive.

For the purposes of the above, the expression an “offer of securities to the public” in relation to any securities in any Member State means the communication in any form and by any means of sufficient information on the terms of the offer and the securities to be offered so as to enable an investor to decide to purchase or subscribe for the securities, as the same may be varied in that Member State by any measure implementing the Prospectus Directive in that Member State (and amendments thereto, including the 2010 PD Amending Directive, to the extent implemented in that Member State), and the expression “Prospectus Directive” means Directive 2003/71/EC and includes any relevant implementing measure in that Member State, and the expression “2010 PD Amending Directive” means Directive 2010/73/EU.

Notice to prospective investors in the United Kingdom.  This prospectus and any other material in relation to the shares described herein is only being distributed to, and is only directed at, persons in the United Kingdom that are qualified investors within the meaning of Article 2(1)(e) of the Prospectus Directive) subjectProspective Directive (“qualified investors”) that also: (i) have professional experience in matters relating to obtaining the prior consent of the Company or any underwriter for any such offer; or

in any other circumstancesinvestments falling within Article 3(2)19(5) of the Prospectus Directive, provided that no such offer of securities shall result in a requirement for the publication by the Company of a prospectus pursuantFinancial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”); (ii) who fall within Article 49(2)(a) to Article 3(d) of the Prospectus Directive.

69


TABLE OF CONTENTS

France

This document is notOrder; or (iii) to whom it may otherwise lawfully be communicated (all such persons together being distributed in the context of a public offering of financial securities (offre au public de titres financiers) in France within the meaning of Article L.411-1 of the French Monetary and Financial Code (Code monétaire et financier) and Articles 211-1 et seq. of the General Regulation of the French Autorité des marchés financiers (“AMF”referred to as “relevant persons”). The securities have not been offered or sold and will not be offered or sold, directly or indirectly,shares are only available to, the public in France.

This document and any other offering material relatinginvitation, offer or agreement to the securities have not been,purchase or otherwise acquire such shares will be engaged in only with, relevant persons. This prospectus and will not be, submitted to the AMF for approval in Franceits contents are confidential and accordingly, mayshould not be distributed, published or causedreproduced (in whole or in part) or disclosed by recipients to distributed, directly or indirectly, to the public in France.

Such offers, sales and distributions have been and shall only be made in France to (i) qualified investors (investisseurs qualifiés) acting for their own account, as defined in and in accordance with Articles L.411-2-II-2° and D.411-1 to D.411-3, D. 744-1, D.754-1 and D.764-1 of the French Monetary and Financial Code and any implementing regulation and/or (ii) a restricted number of non-qualified investors (cercle restreint d’investisseurs) acting for their own account, as defined in and in accordance with Articles L.411-2-II-2° and D.411-4, D.744-1, D.754-1 and D.764-1 of the French Monetary and Financial Code and any implementing regulation.

Pursuant to Article 211-3 of the General Regulation of the AMF, investors in France are informed that the securities cannot be distributed (directly or indirectly) to the public by the investors otherwise than in accordance with Articles L.411-1, L.411-2, L.412-1 and L.621-8 to L.621-8-3 of the French Monetary and Financial Code.

Ireland

The information in this document does not constitute a prospectus under any Irish laws or regulations and this document has not been filed with or approved by any Irish regulatory authority as the information has not been preparedother person in the context of a public offering of securities in Ireland within the meaning of the Irish Prospectus (Directive 2003/71/EC) Regulations 2005 (the “Prospectus Regulations”). The securities have not been offered or sold, and will not be offered, sold or delivered directly or indirectly in Ireland by way of a public offering, except to (i) qualified investors as defined in Regulation 2(l) of the Prospectus Regulations and (ii) fewer than 100 natural or legal persons who are not qualified investors.

Israel

The securities offered by this prospectus have not been approved or disapproved by the Israeli Securities Authority (the ISA), or ISA, nor have such securities been registered for sale in Israel. The shares may not be offered or sold, directly or indirectly, to the public in Israel, absent the publication of a prospectus. The ISA has not issued permits, approvals or licenses in connection with the offering or publishing the prospectus; nor has it authenticated the details included herein, confirmed their reliability or completeness, or rendered an opinion as to the quality of the securities being offered.United Kingdom. Any resale in Israel, directly or indirectly, to the public of the securities offered by this prospectus is subject to restrictions on transferability and must be effected only in compliance with the Israeli securities laws and regulations.

Italy

The offering of the securitiesperson in the Republic of Italy has not been authorized by the Italian Securities and Exchange Commission (Commissione Nazionale per le Societá e la Borsa, “CONSOB” pursuant to the Italian securities legislation and, accordingly, no offering material relating to the securities may be distributed in Italy and such securities may not be offered or sold in Italy in a public offer within the meaning of Article 1.1(t) of Legislative Decree No. 58 of 24 February 1998 (“Decree No. 58”), other than:

to Italian qualified investors, as defined in Article 100 of Decree no.58 by reference to Article 34-ter of CONSOB Regulation no. 11971 of 14 May 1999 (“Regulation no. 1197l”) as amended (“Qualified Investors”); and
in other circumstances that are exempt from the rules on public offer pursuant to Article 100 of Decree No. 58 and Article 34-ter of Regulation No. 11971 as amended.

70


TABLE OF CONTENTS

Any offer, sale or delivery of the securities or distribution of any offer document relating to the securities in Italy (excluding placements where a Qualified Investor solicits an offer from the issuer) under the paragraphs above must be:

made by investment firms, banks or financial intermediaries permitted to conduct such activities in Italy in accordance with Legislative Decree No. 385 of 1 September 1993 (as amended), Decree No. 58, CONSOB Regulation No. 16190 of 29 October 2007 and any other applicable laws; and
in compliance with all relevant Italian securities, tax and exchange controls and any other applicable laws.

Any subsequent distribution of the securities in Italy must be made in compliance with the public offer and prospectus requirement rules provided under Decree No. 58 and the Regulation No. 11971 as amended, unless an exception from those rules applies. Failure to comply with such rules may result in the sale of such securities being declared null and void and in the liability of the entity transferring the securities for any damages suffered by the investors.

Japan

The securities have not been and will not be registered under Article 4, paragraph 1 of the Financial Instruments and Exchange Law of Japan (Law No. 25 of 1948), as amended (the “FIEL”) pursuant to an exemption from the registration requirements applicable to a private placement of securities to Qualified Institutional Investors (as defined in and in accordance with Article 2, paragraph 3 of the FIEL and the regulations promulgated thereunder). Accordingly, the securities may not be offered or sold, directly or indirectly, in Japan or to, or for the benefit of, any resident of Japan other than Qualified Institutional Investors. Any Qualified Institutional Investor who acquires securities may not resell them to any person in JapanUnited Kingdom that is not a Qualified Institutional Investor, and acquisition byrelevant person should not act or rely on this prospectus or any such person of securities is conditional uponits contents.

The distribution of this prospectus in the execution of an agreementUnited Kingdom to that effect.

Portugal

This documentanyone not falling within the above categories is not being distributed inpermitted and may contravene the contextOrder. No person falling outside those categories should treat this prospectus as constituting a promotion to him, or act on it for any purposes whatever. Recipients of a public offer of financial securities (oferta pública de valores mobiliários) in Portugal, withinthis prospectus are advised that we, the meaning of Article 109 of the Portuguese Securities Code (Código dos Valores Mobiliários). The securities have not been offered or sold and will not be offered or sold, directly or indirectly, to the public in Portugal. This documentunderwriter and any other offering material relatingperson that communicates this prospectus are not, as a result solely of communicating this prospectus, acting for or advising them and are not responsible for providing recipients of this prospectus with the protections that would be given to those who are clients of any aforementioned entities that is subject to the securities have not been, and will not be, submittedFinancial Services Authority Rules.

Notice to the Portuguese Securities Market Commission (Comissão do Mercado de Valores Mobiliários) for approvalprospective investors in Portugal and, accordingly, may not be distributed or caused to distributed, directly or indirectly, to the public in Portugal, other than under circumstances that are deemed not to qualify as a public offer under the Portuguese Securities Code. Such offers, sales and distributions of securities in Portugal are limited to persons who are “qualified investors” (as defined in the Portuguese Securities Code). Only such investors may receive this document and they may not distribute it or the information contained in it to any other person.

Sweden

This document has not been, and will not be, registered with or approved by Finansinspektionen (the Swedish Financial Supervisory Authority). Accordingly, this document may not be made available, nor may the securities be offered for sale in Sweden, other than under circumstances that are deemed not to require a prospectus under the Swedish Financial Instruments Trading Act (1991:980) (Sw. lag (1991:980) om handel med finansiella instrument). Any offering of securities in Sweden is limited to persons who are “qualified investors” (as defined in the Financial Instruments Trading Act). Only such investors may receive this document and they may not distribute it or the information contained in it to any other person.

71


TABLE OF CONTENTS

Switzerland

Switzerland.The securitiesshares may not be publicly offered in Switzerland and will not be listed on the SIX Swiss Exchange (“SIX”)(SIX) or on any other stock exchange or regulated trading facility in Switzerland. This documentprospectus has been prepared without regard to the disclosure standards for issuance prospectuses under art. 652a or art. 1156 of the Swiss Code of Obligations or the disclosure standards for listing prospectuses under art. 27 ff. of the SIX Listing Rules or the listing rules of any other stock exchange or regulated trading facility in Switzerland. Neither this documentprospectus nor any other offering or marketing material relating to the securitiesshares or the offering may be publicly distributed or otherwise made publicly available in Switzerland.

Neither this documentprospectus nor any other offering or marketing material relating to the securitiesoffering, us, or the shares have been or will be filed with or approved by any Swiss regulatory authority. In particular, this documentprospectus will not be filed with, and the offer of securitiesshares will not be supervised by, the Swiss Financial Market Supervisory Authority (FINMA).FINMA, and the offer of shares has not been and will not be authorized under the Swiss Federal Act on Collective Investment Schemes, or CISA. The investor protection afforded to acquirers of interests in collective investment schemes under the CISA does not extend to acquirers of the shares.


TABLE OF CONTENTS

Notice to prospective investors in France.This documentprospectus (including any amendment, supplement or replacement thereto) has not been prepared in connection with the offering of our securities that has been approved by the Autorité des marchés financiers or by the competent authority of another State that is personala contracting party to the recipientAgreement on the European Economic Area and notified to the Autorité des marchés financiers; no security has been offered or sold and will be offered or sold, directly or indirectly, to the public in France except to permitted investors, or Permitted Investors, consisting of persons licensed to provide the investment service of portfolio management for the account of third parties, qualified investors (investisseurs qualifiés) acting for their own account and/or corporate investors meeting one of the four criteria provided in article D. 341-1 of the French Code Monétaire et Financier and belonging to a limited circle of investors (cercle restreint d’investisseurs) acting for their own account, with “qualified investors” and “limited circle of investors” having the meaning ascribed to them in Article L. 411-2, D. 411-1, D. 411-2, D. 734-1, D. 744-1, D. 754-1 and D. 764-1 of the French Code Monétaire et Financier; neither this prospectus nor any other materials related to the offer or information contained therein relating to our securities has been released, issued or distributed to the public in France except to Permitted Investors; and the direct or indirect resale to the public in France of any securities acquired by any Permitted Investors may be made only as provided by articles L. 411-1, L. 411-2, L. 412-1 and not for general circulationL. 621-8 to L. 621-8-3 of the French Code Monétaire et Financier and applicable regulations thereunder.

Notice to prospective investors in Switzerland.

United Arab Emirates

Neither this document norItaly.  The offering of the securities has not been registered pursuant to the Italian securities legislation and, accordingly, we have been approved, disapprovednot offered or passed on in any way by the Central Bank of the United Arab Emiratessold, and will not offer or any other governmental authoritysell, our common stock in the United Arab Emirates, nor hasRepublic of Italy in a solicitation to the Company received authorization or licensing from the Central Bankpublic, and that sales of the United Arab Emirates or any other governmental authorityour common stock in the United Arab EmiratesRepublic of Italy shall be effected in accordance with all Italian securities, tax and exchange control and other applicable laws and regulations. In any case, our common stock cannot be offered or sold to any individuals in the Republic of Italy either in the primary market or the secondary market.

We will not offer, sell theor deliver any securities within the United Arab Emirates. This document does not constitute and may not be used for the purposeor distribute copies of an offerthis prospectus or invitation. No services relating to the securities, including the receipt of applications and/or the allotment or redemption of such shares, may be rendered within the United Arab Emirates by the Company.

No offer or invitation to subscribe for securities is valid or permitted in the Dubai International Financial Centre.

United Kingdom

Neither the information in this document nor any other document relating to our common stock in the Republic of Italy except to “Professional Investors,” as defined in Article 31.2 of CONSOB Regulation No. 11522 of 2 July 1998 as amended (“Regulation No. 11522”), pursuant to Article 30.2 and 100 of Legislative Decree No. 58 of 24 February 1998 as amended (“Decree No. 58”), or in any other circumstances where an expressed exemption to comply with the solicitation restrictions provided by Decree No. 58 or Regulation No. 11971 of 14 May 1999 as amended applies, provided, however, that any such offer, sale or delivery of our common stock or distribution of copies of this prospectus or any other document relating to our common stock in the Republic of Italy must be:

(a)made by investment firms, banks or financial intermediaries permitted to conduct such activities in the Republic of Italy in accordance with Legislative Decree No. 385 of 1 September 1993 as amended (“Decree No. 385”), Decree No. 58, CONSOB Regulation No. 11522 and any other applicable laws and regulations;
(b)in compliance with Article 129 of Decree No. 385 and the implementing instructions of the Bank of Italy, pursuant to which the issue, trading or placement of securities in Italy is subject to a prior notification to the Bank of Italy, unless an exemption, depending, inter alia, on the aggregate amount and the characteristics of our common stock issued or offered in the Republic of Italy, applies; and
(c)in compliance with any other applicable notification requirement or limitation which may be imposed by CONSOB or the Bank of Italy.

Notice to prospective investors in Germany.  This prospectus has not been prepared in accordance with the requirements for a securities or sales prospectus under the German Securities Prospectus Act (Wertpapierprospektgesetz), the German Sales Prospectus Act (Verkaufsprospektgesetz), or the German Investment Act (Investmentgesetz). Neither the German Federal Financial Services Supervisory Authority (Bundesanstalt fur Finanzdienstleistungsaufsicht — BaFin) nor any other German authority has been deliverednotified of the intention to distribute shares of our common stock in Germany. Consequently, shares of our common stock may not be distributed in Germany by way of public offering, public advertisement or in any similar manner AND THIS PROSPECTUS AND ANY OTHER DOCUMENT RELATING TO THE OFFERING, AS WELL AS INFORMATION OR STATEMENTS CONTAINED THEREIN, MAY NOT BE SUPPLIED TO THE PUBLIC IN GERMANY OR USED IN CONNECTION WITH ANY OFFER FOR SUBSCRIPTION OF


TABLE OF CONTENTS

SHARES OF OUR COMMON STOCK TO THE PUBLIC IN GERMANY OR ANY OTHER MEANS OF PUBLIC MARKETING. Shares of our common stock are being offered and sold in Germany only to qualified investors which are referred to in Section 3, paragraph 2 no. 1, in connection with Section 2, no. 6, of the German Securities Prospectus Act, Section 8f paragraph 2 no. 4 of the German Sales Prospectus Act, and in Section 2 paragraph 11 sentence 2 no. 1 of the German Investment Act. This prospectus is strictly for approvaluse of the person who has received it. This prospectus may not be forwarded to other persons or published in Germany.

Notice to prospective investors in Norway.  Shares of our common stock will not be offered in Norway other than (i) to investors who are deemed professional investors under Section 5-4 of the Financial Services AuthorityNorwegian Securities Trading Act of 1997 as defined in Regulation no. 1424 of 9 December 2005 (“Professional Investors”); (ii) to fewer than 100 investors that are not Professional Investors or with a total consideration of less than EUR 100,000 calculated over a period of 12 months; or (iii) with a minimum subscription amount of EUR 50,000. Consequently, no public offering will be made in Norway and this prospectus has not been filed with or approved by any Norwegian authority. This prospectus must not be reproduced or otherwise distributed to others by the recipient.

Notice to prospective investors in Finland.  This prospectus has not been prepared to comply with the standards and requirements regarding public offering set forth in the United KingdomFinnish Securities Market Act (1989/495, as amended) and no prospectus (withinit has not been approved by the meaningFinnish Financial Supervision Authority. Shares of section 85 of the Financial Services and Markets Act 2000, as amended (“FSMA”)) has been published or is intended to be published in respect of the securities. This document is issued on a confidential basis to “qualified investors” (within the meaning of section 86(7) of FSMA) in the United Kingdom, and the securitiesour common stock may not be offered, sold, advertised or soldotherwise marketed in the United Kingdom by means of this document, any accompanying letter or any other document, except inFinland under circumstances which do not requireconstitute public offering of securities under Finnish law.

Acceptance of prospectus.  By accepting this prospectus, the publication of a prospectus pursuantrecipient represents and warrants that he is entitled to section 86(1) FSMA. This document should not be distributed, published or reproduced,receive it in whole or in part, nor may its contents be disclosed by recipients to any other person in the United Kingdom.

Any invitation or inducement to engage in investment activity (within the meaning of section 21 of FSMA) received in connectionaccordance with the issue or sale of the securities has only been communicated or causedrestrictions set forth above and agrees to be communicated and will only be communicated or causedbound by limitations contained herein. Any failure to be communicated in the United Kingdom in circumstances in which section 21(1)comply with these limitations may constitute a violation of FSMA does not apply to the Company.

In the United Kingdom, this document is being distributed only to, and is directed at, persons (i) who have professional experience in matters relating to investments falling within Article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotions) Order 2005 (“FPO”), (ii) who fall within the categories of persons referred to in Article 49(2)(a) to (d) (high net worth companies, unincorporated associations, etc.) of the FPO or (iii) to whom it may otherwise be lawfully communicated (together “relevant persons”). The investments to which this document relates are available only to, and any invitation, offer or agreement to purchase will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this document or any of its contents.law.


72


 

TABLE OF CONTENTS

LEGAL MATTERS

The validity of the securities being offered hereby will be passed upon for us by Ballard Spahr LLP, Philadelphia, Pennsylvania. CertainFaegre Baker Daniels LLP, Denver, Colorado, has acted as counsel for the underwriter in connection with certain legal matters will be passed upon for the underwriters by Reed Smith LLP, New York, New York.related to this offering.

EXPERTS

The audited financial statements of AspenBio Pharma,Venaxis, Inc., included herein have been audited by GHP Horwath, P.C., independent registered public accounting firm, for the periods and to the extent set forth in their report (which contains an explanatory paragraph relating to the Company’s ability to continue as a going concern) appearing herein. Such financial statements have been so included in reliance upon the report of such firm given upon the firm’s authority as an expert in auditing and accounting.

WHERE YOU CAN FIND MORE INFORMATION

We have filed with the SEC a registration statement on Form S-1 relatingunder the Securities Act to the securities covered byregister our common stock being offered in this prospectus. This prospectus, iswhich constitutes a part of the registration statement, and does not contain all the information set forth in the registration statement.statement or the exhibits and schedules filed thereto. For further information with respect toabout us and theour securities we are offering underoffered by this prospectus, we refer you to the registration statement and the exhibits and schedules filed as a part ofwith the registration statement. We also file annual, quarterlyAny statement contained in this prospectus regarding the contents of any contract or any other document that is filed as an exhibit to the registration statement is not necessarily complete and current reports, proxy statements andeach such statement is qualified in all respects by reference to the full text of such contract or other information withdocument filed as an exhibit to the SEC.registration statement. You may read and copy the registration statement, as well as any other materialmaterials we file with the SEC, including the registration statement, at the SEC’s Public Reference Room at 100 F Street, N.E.,NE, Washington, D.C. 20549. Please call20549, on official business days during the hours of 10:00 a.m. to 3:00 p.m. You may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330 for more information on the Public Reference Room.1-800-SEC-0330. The SEC also maintains an Internet sitewebsite that contains reports, proxy and information statements and other information regardingabout issuers, like us, that file electronically with the SEC, including AspenBio.SEC. The SEC’s Internet site can be found ataddress of that website ishttp://www.sec.gov.www.sec.gov

. Information on or accessible through the SEC’s website is not a part of this prospectus. You may also inspect our SEC reports and other information at our website atwww.venaxis.com. Information on or accessible through our website is not a part of this prospectus. We are subject to the information reporting requirements of the Exchange Act, and file periodic reports, proxy statements and other information with the SEC. Such periodicThese reports, proxy statements and other information are available for inspection and copying at the public reference room and website of the SEC referred to above. We maintain a website athttp://www.aspenbiopharma.com. You may access our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act with the SEC free of charge at our website as soon as reasonably practicable after such material is electronically filed with, or furnished to, the SEC. The information and other content contained on our website are not part of the prospectus.


73


 

TABLE OF CONTENTS

VENAXIS, INC.

INDEX TO FINANCIAL STATEMENTS

The accompanying financial statements and notes thereto, have not been adjusted to reflect the 1-for-6 reverse stock split anticipated to be effected immediately prior to the date of this prospectus.


F-1


 

TABLE OF CONTENTS

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

Board of Directors and Shareholders
AspenBio Pharma,Venaxis, Inc.

We have audited the accompanying balance sheets of Venaxis, Inc. (formerly AspenBio Pharma, Inc.) (“the Company”) as of December 31, 20112012 and 2010,2011, and the related statements of operations, stockholders’ equity, and cash flows for each of the three years in the period ended December 31, 2011.2012. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of AspenBio Pharma,Venaxis, Inc. as of December 31, 20112012 and 2010,2011, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2011,2012, in conformity with accounting principles generally accepted in the United States of America.

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has suffered recurring losses and negative cash flows from operations that raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

/s/ GHP HORWATH, P.C.



Denver, Colorado
March 16, 201226, 2013


F-2


 

TABLE OF CONTENTS

AspenBio Pharma,Venaxis, Inc.
  
Balance Sheets
December 31,

  
 2012 2011
ASSETS
          
Current assets:
          
Cash and cash equivalents $10,977,974  $2,968,104 
Short-term investments (Note 1)  1,162,904   1,003,124 
Accounts receivable (Note 1)     35,016 
Prepaid expenses and other current assets  387,480   314,800 
Total current assets  12,528,358   4,321,044 
Property and equipment, net (Note 2)  2,484,539   2,795,149 
Other long term assets, net (Notes 1 and 3)  1,601,894   1,611,652 
Total assets $16,614,791  $8,727,845 
LIABILITIES AND STOCKHOLDERS’ EQUITY
          
Current liabilities:
          
Accounts payable $613,925  $581,713 
Accrued compensation  452,878   47,622 
Accrued expenses  642,055   368,406 
Notes and other obligations, current portion (Note 4)  2,290,292   1,074,185 
Deferred revenue, current portion (Note 7)  79,803    
Total current liabilities  4,078,953   2,071,926 
Notes and other obligations, less current portion (Note 4)  763,132   2,830,041 
Deferred revenue, less current portion (Note 7)  1,081,706    
Total liabilities  5,923,791   4,901,967 
Commitments and contingencies (Notes 7 and 10)
          
Stockholders’ equity (Notes 5 and 6):
          
Common stock, no par value, 30,000,000 shares authorized;
9,954,380 and 1,608,146 shares issued and outstanding
  84,924,133   68,846,796 
Accumulated deficit  (74,233,133  (65,020,918
Total stockholders’ equity  10,691,000   3,825,878 
Total liabilities and stockholders’ equity $16,614,791  $8,727,845 
  
 2011 2010
ASSETS
          
Current assets:
          
Cash and cash equivalents $2,968,104  $8,908,080 
Short term investments (Note 1)  1,003,124   2,932,188 
Accounts receivable (Note 1)  35,016   73,176 
Prepaid expenses and other current assets  314,800   393,177 
Total current assets  4,321,044   12,306,621 
Property and equipment, net (Note 2)  2,795,149   3,107,134 
Other long term assets, net (Notes 1 and 3)  1,611,652   1,745,350 
Total assets $8,727,845  $17,159,105 
LIABILITIES AND STOCKHOLDERS’ EQUITY
          
Current liabilities:
          
Accounts payable $581,713  $1,126,172 
Accrued compensation  47,622   227,570 
Accrued expenses  368,406   357,685 
Deferred revenue, current portion (Note 9)     746,062 
Notes and other obligations, current portion (Note 4)  1,074,185   273,861 
Total current liabilities  2,071,926   2,731,350 
Notes and other obligations, less current portion (Note 4)  2,830,041   2,546,682 
Deferred revenue, less current portion (Note 9)     633,636 
Total liabilities  4,901,967   5,911,668 
Commitments and contingencies (Note 9)
          
Stockholders’ equity (Notes 5 and 6):
          
Common stock, no par value, 30,000,000 shares authorized; 9,633,321 and 8,028,321 shares issued and outstanding  68,846,796   66,054,554 
Accumulated deficit  (65,020,918  (54,807,117
Total stockholders’ equity  3,825,878   11,247,437 
Total liabilities and stockholders’ equity $8,727,845  $17,159,105 



See Accompanying Notes to Financial Statements

F-3



 

TABLE OF CONTENTS

AspenBio Pharma,Venaxis, Inc.
  
Statements of Operations
Years ended December 31,

   
 2012 2011 2010
Sales (Note 1) $41,557  $219,420  $370,229 
Cost of sales  592   16,345   358,094 
Gross profit  40,965   203,075   12,135 
Other revenue – fee (Note 7)  20,571   62,179   68,394 
Operating expenses:
               
Selling, general and administrative  5,184,823   5,575,221   7,417,686 
Research and development  3,838,375   5,666,221   6,112,405 
Total operating expenses  9,023,198   11,241,442   13,530,091 
Operating loss  (8,961,662  (10,976,188  (13,449,562
Other income (expense):
               
Interest, net  (248,629  (180,509  (132,786
Gain on contract termination (Note 7)     938,896    
Other income (expense) (Note 8)  (1,924  4,000   244,629 
Total other (expense) income  (250,553  762,387   111,843 
Net loss $(9,212,215 $(10,213,801 $(13,337,719
Basic and diluted net loss per share (Note 1) $(1.84 $(7.61 $(10.17
Basic and diluted weighted average number of common shares outstanding (Notes 1 and 5)  4,996,827   1,341,379   1,310,956 
   
 2011 2010 2009
Sales (Note 1) $219,420  $370,229  $290,872 
Cost of sales  16,345   358,094   710,207 
Gross profit (loss)  203,075   12,135   (419,335
Other revenue – fee (Note 9)  62,179   68,394   213,947 
Operating expenses:
               
Selling, general and administrative  5,575,221   7,417,686   6,052,968 
Research and development  5,666,221   6,112,405   9,291,637 
Total operating expenses  11,241,442   13,530,091   15,344,605 
Operating loss  (10,976,188  (13,449,562  (15,549,993
Other income (expense):
               
Interest income  16,424   61,696   189,429 
Interest expense  (196,933  (194,482  (200,136
Gain on contract termination (Note 9)  938,896       
Other income (Note 7)  4,000   244,629   43,135 
Total other income, net  762,387   111,843   32,428 
Net loss $(10,213,801 $(13,337,719 $(15,517,565
Basic and diluted net loss per share (Note 1) $(1.27 $(1.69 $(2.34
Basic and diluted weighted average number of common shares outstanding (Notes 1 and 5)  8,032,718   7,876,081   6,634,490 



See Accompanying Notes to Financial Statements

F-4



 

TABLE OF CONTENTS

AspenBio Pharma,Venaxis, Inc.
  
Statements of Stockholders’ Equity
Years ended December 31, 2012, 2011 2010 and 20092010

    
 Common Stock Accumulated
Deficit
   Shares Amount Total
Balance, January 1, 2010  1,251,624  $54,283,126  $(41,469,398 $12,813,728 
Common stock options exercised  8,701   291,028      291,028 
Stock-based compensation issued for services     2,363,871      2,363,871 
Common stock issued for cash, net of offering costs of $883,471  80,321   9,116,529      9,116,529 
Net loss for the year        (13,337,719  (13,337,719
Balance, December 31, 2010  1,340,646   66,054,554   (54,807,117  11,247,437 
Stock-based compensation issued for services     1,336,177      1,336,177 
Common stock issued for cash, net of offering costs of $181,035  267,500   1,456,065      1,456,065 
Net loss for the year        (10,213,801  (10,213,801
Balance, December 31, 2011  1,608,146   68,846,796   (65,020,918  3,825,878 
Stock-based compensation issued for services     901,161      901,161 
Common stock issued for consulting services  8,334   29,776      29,776 
Common stock issued for cash, net of offering costs of $1,753,190  8,337,900   15,146,400      15,146,400 
Net loss for the year        (9,212,215  (9,212,215
Balance, December 31, 2012  9,954,380  $84,924,133  $(74,233,133 $10,691,000 
    
 Common Stock Accumulated
Deficit
 Total
   Shares Amount
Balance, January 1, 2009  6,235,817  $43,839,785  $(25,951,833 $17,887,952 
Common stock options and warrants exercised  227,367   468,640      468,640 
Stock-based compensation issued for services     1,714,936      1,714,936 
Common stock issued for cash, net of offering costs of $503,735  1,031,000   8,259,765      8,259,765 
Net loss for the year        (15,517,565  (15,517,565
Balance, December 31, 2009  7,494,184   54,283,126   (41,469,398  12,813,728 
Common stock options exercised  52,209   291,028      291,028 
Stock-based compensation issued for services     2,363,871      2,363,871 
Common stock issued for cash, net of offering costs of $883,471  481,928   9,116,529      9,116,529 
Net loss for the year        (13,337,719  (13,337,719
Balance, December 31, 2010  8,028,321   66,054,554   (54,807,117  11,247,437 
Stock-based compensation issued for services     1,336,177      1,336,177 
Common stock issued for cash, net of offering costs of $181,035  1,605,000   1,456,065      1,456,065 
Net loss for the year        (10,213,801  (10,213,801
Balance, December 31, 2011  9,633,321  $68,846,796  $(65,020,918 $3,825,878 



See Accompanying Notes to Financial Statements

F-5



 

TABLE OF CONTENTS

AspenBio Pharma,Venaxis, Inc.
  
Statements of Cash Flows
Years ended December 31,

   
 2012 2011 2010
Cash flows from operating activities:
               
Net loss $(9,212,215 $(10,213,801 $(13,337,719
Adjustments to reconcile net loss to net cash used by operating activities:
               
Stock-based compensation for services  930,937   1,336,177   2,363,871 
Depreciation and amortization  430,228   490,515   492,160 
Impairment charges  44,554   274,941   107,443 
Amortization of license fee  (20,571  (62,179  (68,394
Gain on contract termination     (938,896   
Loss on equipment disposals  1,924       
(Increase) decrease in:
               
Accounts receivable  35,016   38,160   (25,217
Prepaid expenses and other current assets  407,955   426,825   403,271 
Increase (decrease) in:
               
Accounts payable  32,212   284,543   (419,377
Accrued expenses  273,649   210,721   (206,737
Accrued compensation  405,256   (179,948  (15,915
Deferred revenue  1,182,080       
Net cash used in operating activities  (5,488,975  (8,332,942  (10,706,614
Cash flows from investing activities:
               
Purchases of investment securities  (2,991,644  (1,043,192  (7,628,977
Sales of investment securities  2,831,864   2,972,256   5,206,909 
Purchases of property and equipment  (43,692  (90,100  (191,509
Patent and trademark application costs  (112,646  (228,163  (309,898
Net cash (used in) provided by investing activities  (316,118  1,610,801   (2,923,475
Cash flows from financing activities:
               
Repayment of notes payable and other obligations  (1,331,437  (673,900  (236,165
Net proceeds from issuance of common stock  15,146,400   1,456,065   9,116,529 
Proceeds from exercise of warrants and options        291,028 
Net cash provided by financing activities  13,814,963   782,165   9,171,392 
Net increase (decrease) in cash and cash equivalents  8,009,870   (5,939,976  (4,458,697
Cash and cash equivalents, at beginning of year  2,968,104   8,908,080   13,366,777 
Cash and cash equivalents, at end of year $10,977,974  $2,968,104  $8,908,080 
Supplemental disclosure of cash flow information:
               
Cash paid during the year for:
               
Interest $244,737  $180,915  $194,533 
Schedule of non-cash investing and financing transactions:
               
Acquisitions of assets for installment obligations $480,635  $454,830  $293,873 
   
 2011 2010 2009
Cash flows from operating activities:
               
Net loss $(10,213,801 $(13,337,719 $(15,517,565
Adjustments to reconcile net loss to net cash used by operating activities:
               
Depreciation and amortization  490,515   492,160   388,203 
Impairment charges  274,941   107,443   565,242 
Non-cash charges        7,995 
Amortization of license fee  (62,179  (68,394  (213,947
Stock-based compensation for services  1,336,177   2,363,871   1,714,936 
Gain on contract termination  (938,896      
(Increase) decrease in:
               
Accounts receivable  38,160   (25,217  15,235 
Prepaid expenses and other current assets  426,825   403,271   846,029 
Increase (decrease) in:
               
Accounts payable  284,543   (419,377  662,309 
Accrued expenses  30,773   (222,652  167,916 
Net cash used in operating activities  (8,332,942  (10,706,614  (11,363,647
Cash flows from investing activities:
               
Purchases of investment securities  (1,043,192  (7,628,977  (2,307,248
Sales of investment securities  2,972,256   5,206,909   7,436,336 
Purchases of property and equipment  (90,100  (191,509  (243,769
Patent and trademark application costs  (228,163  (309,898  (352,184
Net cash provided by (used in) investing activities  1,610,801   (2,923,475  4,533,135 
Cash flows from financing activities:
               
Repayment of notes payable and other obligations  (673,900  (236,165  (350,621
Net proceeds from issuance of common stock  1,456,065   9,116,529   8,259,765 
Proceeds from exercise of warrants and options     291,028   468,640 
Net cash provided by financing activities  782,165   9,171,392   8,377,784 
Net increase (decrease) in cash and cash equivalents  (5,939,976  (4,458,697  1,547,272 
Cash and cash equivalents, at beginning of year  8,908,080   13,366,777   11,819,505 
Cash and cash equivalents, at end of year $2,968,104  $8,908,080  $13,366,777 
Supplemental disclosure of cash flow information:
               
Cash paid during the year for:
               
Interest $180,915  $194,533  $186,700 
Schedule of non-cash investing and financing transactions:
               
Acquisitions of assets for installment obligations $454,830  $293,873  $ 



See Accompanying Notes to Financial Statements

F-6



 

TABLE OF CONTENTS

AspenBio Pharma,Venaxis, Inc.
  
Notes to Financial Statements

Note 1. Organization and summary of significant accounting policies:

Nature of operations:

AspenBio Pharma,Venaxis, Inc. (the “Company” or “AspenBio Pharma”“Venaxis”) was organized on July 24, 2000, as a Colorado corporation. In December 2012, the Company’s name was changed to Venaxis, Inc., from AspenBio Pharma’sPharma, Inc. Venaxis’ business is in the development and commercialization of innovative products that address unmet diagnostic and therapeutic needs. The Company’s lead product candidate, AppyScore,APPY1, is designed to be a novel blood-based diagnostic test that, if successfully cleared to be marketed by the FDA,United States Food and Drug Administration (“FDA”), will aid, through the test’s negative predictive value, in the evaluation of low risk patients initially suspected of having acute appendicitis, thereby helping address the difficult challenge of triaging possible acute appendicitis patients in the hospital emergency department or urgent care settings.

The Company’s research and development activities are currently focused primarily on a human acute appendicitis blood-based test.

Going concern, management’sManagement’s plans and basis of presentation:

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company has experienced recurring losses and negative cash flows from operations, and atoperations. At December 31, 20112012, the Company had approximate balances of cash and liquid investments of $3,971,000,$12,141,000, working capital of $2,249,000,$8,449,000, total stockholders’ equity of $3,826,000$10,691,000 and an accumulated deficit of $65,021,000.$74,233,000. To date, the Company has in large part relied on equity financing to fund its operations. The Company expects to continue to incur losses from operations for the near-term and these losses could be significant as product development, clinical and regulatory activities, contract consulting and other product development related expenses are incurred. The Company believes that its current working capital position will not be sufficient to meet its estimated cash needs for the remainder of 2012. These factors raise substantial doubt about the Company’s ability to continue as a going concern.2013 and at least into 2014. If the Company does not obtain additional capital, then the Company would potentially be required to reduce the scope of its research and development activities or cease operations. The Company is actively lookingcontinues to obtainexplore obtaining additional financing; however, there can be no assurance that the Company will be able to obtain sufficient additional financing on terms acceptable to the Company, if at all, or that they will not have significantly dilutive effect on the Company’s existing shareholders.financing. The Company is closely monitoring its cash balances, cash needs and expense levels. The accompanying financial statements do notIn addition the Company’s first mortgage which is held by a commercial bank requires a balloon payment of approximately $1.6 million due in July 2013.

Management’s strategic plans include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that might result should the Company be unable to continue as a going concern.

The Company’s ability to continue as a going concern depends on the success of management’s plans to bridge such cash shortfalls in 2012, which includes the following:

continuing to advance development of the Company’s principal product,APPY1;
aggressively pursuing additional capital raising activities in 2012;
continuing to advance development of the Company’s products, particularly AppyScore;
continuing to advance the strategic process to monetize the Company’s animal health business and related intellectual property;opportunities;
continuing to explore prospective partnering or licensing opportunities with complementary opportunities and technologies; and
continuing to monitor and implement cost control initiatives to conserve cash.cash; and
refinance the portion of the mortgage payable in July 2013.

Cash, cash equivalents and short termshort-term investments:

The Company considers all highly liquid investments with an original maturity of three months or less at the date of acquisition to be cash equivalents. From time to time, the Company’s cash account balances exceed the balances as covered by the Federal Deposit Insurance System. The Company has never suffered a loss due to such excess balances.

F-7


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Financial Statements

Note 1. Organization and summary of significant accounting policies: - (continued)

The Company invests excess cash from time to time in highly-liquid debt and equity investments of highly-rated entities which are classified as trading securities. The purpose of the investments is to fund research and development, product development, U.S. Food and Drug Administration (the “FDA”)FDA approval-related activities and general corporate purposes. Such amounts are recorded at market values using Level 1 inputs in determining fair value and are classified as current, as the Company does not intend to hold the investments beyond twelve months. Investment securities classified as trading are those securities that are bought and held principally for the


TABLE OF CONTENTS

Venaxis, Inc.

Notes to Financial Statements

Note 1. Organization and summary of significant accounting policies:  – (continued)

purpose of selling them in the near term, with the objective of preserving principal and generating profits. These securities are reported at fair value with unrealized gains and losses reported as an element of other income (expense) in current period earnings. The Board of Directors has approved an investment policy covering the investment parameters to be followed with the primary goals being the safety of principal amounts and maintaining liquidity of the fund. The policy provides for minimum investment rating requirements as well as limitations on investment duration and concentrations. Based upon market conditions, the investment guidelines have been tightened to increase the minimum acceptable investment ratings required for investments and shorten the maximum investment term. As of December 31, 2011, 64%2012, 89% of the investment portfolio was in cash equivalents, which is presented as such on the accompanying balance sheet, and the remaining funds were invested in short-term marketable securities with none individually representing more than 16% ofa material amount to the portfolio and none with maturities past June 2012. To date,November 2013. As of December 31, 2012, the Company’s cumulative realized market loss from the investments has not been in excess of $5,000. For the year ended December 31, 2012, there was $11,192 in unrealized loss, $102 in realized gain for the year and $5,532 in management fees. For the year ended December 31, 2011, there was $1,004 in unrealized loss, $3,505 in realized loss, $1,073 in realized gain for the year and $9,248 in management fees. For the year ended December 31, 2010, there was $1,065 in unrealized income, $1,388 in unrealized loss, $2,023 in realized gain for the year and $17,959 in management fees. For

Fair value of financial instruments:

The Company accounts for financial instruments under Financial Accounting Standards Board (FASB) Accounting Standards Codification Topic (ASC) 820, Fair Value Measurements. This statement defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles, and expands disclosures about fair value measurements. To increase consistency and comparability in fair value measurements, ASC 820 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels as follows:

Level 1 — quoted prices (unadjusted) in active markets for identical assets or liabilities;
Level 2 — observable inputs other than Level 1, quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, and model-derived prices whose inputs are observable or whose significant value drivers are observable; and
Level 3 — assets and liabilities whose significant value drivers are unobservable.

Observable inputs are based on market data obtained from independent sources, while unobservable inputs are based on the Company’s market assumptions. Unobservable inputs require significant management judgment or estimation. In some cases, the inputs used to measure an asset or liability may fall into different levels of the fair value hierarchy. In those instances, the fair value measurement is required to be classified using the lowest level of input that is significant to the fair value measurement. Such determination requires significant management judgment. There were no financial assets or liabilities measured at fair value, with the exception of cash, cash equivalents (level 1) and short-term investments (level 2) as of December 31, 2012 and December 31, 2011.

The carrying amounts of the Company’s financial instruments (other than cash, cash equivalents and short-term investments as discussed above) approximate fair value because of their variable interest rates and/or short maturities combined with the recent historical interest rate levels.


TABLE OF CONTENTS

Venaxis, Inc.

Notes to Financial Statements

Note 1. Organization and summary of significant accounting policies:  – (continued)

Revenue recognition and accounts receivable:

We recognize sales of goods under the provisions of the FASB ASC 605 (“ASC 605”) and the U.S. Securities and Exchange Commission (SEC) Staff Accounting Bulletin (SAB) 104,Revenue Recognition. Future revenue is expected to be generated primarily from the sale of products. Product revenue primarily consists of sales of instrumentation and consumables.

Revenue is recognized when the following four basic criteria have been met: (i) persuasive evidence of an arrangement exists; (ii) delivery has occurred and risk of loss has passed; (iii) the seller’s price to the buyer is fixed or determinable; and (iv) collectability is reasonably assured.

In international markets, the Company sells its products to distributors or re-sellers, who subsequently resell the products to hospitals. The Company has an agreement with the distributor which provides that title and risk of loss pass to the distributor upon shipment of the products, FOB to the distributor. Revenue is recognized upon shipment of products to the distributor as the products are shipped based on FOB shipping point terms.

Revenues are recorded less a reserve for estimated product returns and allowances which to date has not been significant. Determination of the reserve for estimated product returns and allowances is based on management’s analyses and judgments regarding certain conditions. Should future changes in conditions prove management’s conclusions and judgments on previous analyses to be incorrect, revenue recognized for any reporting period could be adversely affected.

The Company extends credit to customers generally without requiring collateral. Historically, the Company’s base antigen business has sold products primarily throughout North America. At December 31, 2012, the Company did not have any accounts receivable. At December 31, 2011, two customers accounted for 73% and 19% of total accounts receivable. During the year ended December 31, 2012, three customers accounted for a total of 83% of net sales, each representing 40%, 30% and 13%, respectively. During the years ended December 31, 2011 and 2010, one European-based company, accounted for a total of 3% and 4%, respectively of our net sales. During the year ended December 31, 2011, two customers accounted for a total of 42% of net sales, each representing 28% and 14%, respectively. During the year ended December 31, 2010, four customers accounted for a total of 58% of net sales, each representing 19%, 18%, 11% and 10%, respectively.

Property and equipment:

Property and equipment is stated at cost and depreciated using the straight-line method over the estimated useful lives of the assets, generally twenty-five years for the building, ten years for land improvements, five years for equipment and three years for computer related assets.

Goodwill:

Goodwill, arose from the initial formation of the Company, and represents the purchase price paid and liabilities assumed in excess of the fair market value of tangible assets acquired. The Company performs a goodwill impairment analysis in the fourth quarter of each year, or whenever there is an indication of impairment. When conducting its annual goodwill impairment assessment, the Company initially performs a qualitative evaluation to determine if it is more likely than not that the fair value of its reporting unit is less than its carrying amount as a basis for determining whether it is necessary to perform a two-step goodwill impairment test. The Company has determined, based on its qualitative evaluation, that it was not necessary to perform the two-step goodwill impairment test and that no impairment had occurred as of December 31, 2012.

Impairment of long-lived assets:

Management reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is


TABLE OF CONTENTS

Venaxis, Inc.

Notes to Financial Statements

Note 1. Organization and summary of significant accounting policies:  – (continued)

measured by a comparison of the carrying amount of an asset to undiscounted future cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. Based on its review, including an updated assessment subsequent to year end, management determined that certain costs previously incurred for patents had been impaired during the years ended December 31, 2012, 2011 and 2010. Approximately $45,000, $275,000 and $107,000 of such patent costs were determined to be impaired during the years ended December 31, 2012, 2011 and 2010, respectively resulting from management’s decisions not to pursue patents based upon a cost benefit analysis of patent expenses and coverage protection in several smaller world markets that were determined to not have the economic or fiscal potential to make the patent pursuit viable. Impairment charges are included in research and development expenses in the accompanying statements of operations.

Research and development:

Research and development costs are charged to expense as incurred.

Use of estimates:

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (GAAP) requires management to make estimates and assumptions that affect reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the balance sheet and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ significantly from those estimates.

Income taxes:

The Company accounts for income taxes under the asset and liability method, in which deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. A valuation allowance is required to the extent any deferred tax assets may not be realizable.

The Company does not have an accrual for uncertain tax positions as of December 31, 2012 and 2011. The Company files corporate income tax returns with the Internal Revenue Service and the states where the Company determines it is required to do so, and there are open statutes of limitations for tax authorities to audit the Company’s tax returns from 2009 through the current period.

The Company’s policy is to recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. At December 31, 2012, the Company did not have any accrued interest or penalties associated with any unrecognized tax benefits, nor was any interest expense recognized during the years ended December 31, 2012, 2011 or 2010.

Stock-based compensation:

Venaxis recognizes the cost of employee services received in exchange for an award of equity instruments in the financial statements and is measured based on the grant date fair value of the award. Stock option compensation expense is recognized over the period during which an employee is required to provide service in exchange for the award (generally the vesting period). The Company estimates the fair value of each stock option at the grant date by using the Black-Scholes option pricing model.

Reclassifications:

Certain prior period amounts in the accompanying financial statements have been reclassified to conform to the presentation used in 2012.


TABLE OF CONTENTS

Venaxis, Inc.

Notes to Financial Statements

Note 1. Organization and summary of significant accounting policies:  – (continued)

Income (loss) per share:

ASC 260, Earnings Per Share, requires dual presentation of basic and diluted earnings per share (EPS) with a reconciliation of the numerator and denominator of the basic EPS computation to the numerator and denominator of the diluted EPS computation. Basic EPS excludes dilution. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity.

Basic earnings (loss) per share includes no dilution and is computed by dividing net earnings (loss) available to stockholders by the weighted average number of common shares outstanding for the period. Diluted earnings per share reflect the potential dilution of securities that could share in the Company’s earnings (loss). The effect of the inclusion of the dilutive shares would have resulted in a decrease in loss per share during the years ended December 31, 2012, 2011 and 2010. Accordingly, the weighted average shares outstanding have not been adjusted for dilutive shares. Outstanding stock options and warrants are not considered in the calculation, as the impact of the potential common shares (totaling approximately 1,306,000, 497,000 and 214,000 shares for each of the years ended December 31, 2012, 2011 and 2010, respectively) would be to decrease the net loss per share.

In May 2012, the Board of Directors authorized a reverse stock split of the Company’s common stock at a ratio of one-for-six, whereby each six shares of common stock were combined into one share of common stock (the “2012 Reverse Stock Split”). All historical references to shares and share amounts in this report have been retroactively revised to reflect the 2012 Reverse Stock Split, the principal effects of which were to:

1.reduce the number of shares of common stock issued and outstanding by a factor of 6;
2.increase the per share exercise price of options and warrants by a factor of 6, and decrease the number of shares issuable upon exercise by a factor of 6, for all outstanding options and warrants entitling the holders to purchase shares of the Company’s common stock; and
3.proportionately reduce the number of shares authorized and reserved for issuance under the Company’s existing equity compensation plans.

A reconciliation of historical basic and diluted weighted average number of shares outstanding retroactively adjusted for the 2012 Reverse Stock Split follows:

  
 Year ended December 31,
   2011 2010
Basic and diluted weighted average number of shares outstanding
          
Pre-split  8,032,178   7,876,081 
Post-split  1,341,379   1,310,956 

Recently issued and adopted accounting pronouncements:

The Company has evaluated all recently issued accounting pronouncements and believes such pronouncements do not have a material effect on the Company’s financial statements.


TABLE OF CONTENTS

Venaxis, Inc.

Notes to Financial Statements

Note 2. Property and equipment:

Property and equipment consisted of the following as of December 31:

  
 2012 2011
Land and improvements $1,107,508  $1,107,508 
Building  2,589,231   2,589,231 
Building improvements  251,049   251,049 
Laboratory equipment  1,211,418   1,175,047 
Office and computer equipment  403,692   398,295 
    5,562,898   5,521,130 
Less accumulated depreciation  3,078,359   2,725,981 
   $2,484,539  $2,795,149 

Depreciation expense totaled approximately $352,000, $402,000 and $395,000 for each of years ended December 31, 2012, 2011 and 2010, respectively.

Note 3. Other long-term assets:

Other long-term assets consisted of the following as of December 31:

  
 2012 2011
Patents, trademarks and applications, net of accumulated amortization of $345,692 and $273,550 $1,210,698  $1,214,748 
Goodwill  387,239   387,239 
Other  3,957   9,665 
   $1,601,894  $1,611,652 

The Company capitalizes legal costs and filing fees associated with obtaining patents on its new discoveries. Once the patents have been issued, the Company amortizes these costs over the shorter of the legal life of the patent or its estimated economic life using the straight-line method. Based upon the current status of the above intangible assets, the aggregate amortization expense is estimated to be approximately $75,000 for each of the next five fiscal years. The Company tests intangible assets with finite lives upon significant changes in the Company’s business environment. The testing resulted in approximately $45,000, $275,000, and $107,000 of patent impairment charges during the years ended December 31, 2012, 2011, and 2010, respectively.

Note 4. Notes and other obligations:

Notes payable and installment obligations consisted of the following as of December 31:

  
 2012 2011
Mortgage notes $2,435,073  $2,545,312 
Termination obligation (Note 7)  397,588   1,152,753 
Other short-term installment obligations  220,763   206,161 
    3,053,424   3,904,226 
Less current portion  2,290,292   1,074,185 
   $763,132  $2,830,041 

Mortgage notes:

The Company has a mortgage facility on its land and building. The mortgage is held by a commercial bank and includes approximately 35% that is guaranteed by the U.S. Small Business Administration (SBA). The loan is collateralized by the real property and is also personally guaranteed by a former officer of the Company. The interest rate on the bank portion is one percentage over the Wall Street Journal Prime Rate


TABLE OF CONTENTS

Venaxis, Inc.

Notes to Financial Statements

Note 4. Notes and other obligations:  – (continued)

(minimum 7%), with 7% being the approximate effective rate for 2012 and 2011, and the SBA portion bears interest at the rate of 5.86%. The commercial bank portion of the loan requires total monthly payments of approximately $14,200, which includes approximately $9,500 per month in interest, through July 2013 when the then remaining principal balance is due which is estimated to be approximately $1.6 million at that time. The SBA portion of the loan requires total monthly payments of approximately $9,200 through July 2023, which includes approximately $3,900 per month in interest and fees.

Termination obligation:

In November 2011, the Company entered into a Termination Agreement with Novartis Animal Health, Inc. (the “Novartis Termination Agreement”) to terminate the Novartis License Agreement (Note 7). Under the Novartis Termination Agreement, the termination obligation originally totaled $1,374,000, which was payable $150,000 upon signing the Novartis Termination Agreement and in six equal subsequent quarterly installments of $204,000 each. The Company discounted this obligation at an assumed interest rate of 7% (which represents the rate management believes it could have borrowed at for similar financings), which totaled $1,303,000. At December 31, 2012, the remaining outstanding termination obligation totaled approximately $398,000 which is due in 2013.

Other short-term installment obligations:

The Company has executed financing agreements for certain of the Company’s insurance premiums. At December 31, 2012, these obligations totaled $220,763 all of which are due in 2013.

Future maturities:

The Company’s total debt obligations require minimum annual principal payments of approximately $2,290,000 in 2013, $65,000 in 2014, $68,000 in 2015, $72,000 in 2016, $75,000 in 2017 and $483,000 thereafter, through the terms of the applicable debt agreements. The Company’s Exclusive License Agreement with The Washington University also requires minimum annual royalty payments of $20,000 per year during its term (Note 7).

Note 5. Stockholders’ equity:

2012 Transactions:

In June 2012, the Company completed a public offering of securities consisting of 6,100,000 shares of common stock at an offering price of $2.00 per share, generating approximately $12.2 million in total proceeds. Fees and other expenses totaled $1,261,000, including an underwriter’s fee of 7%. In connection with the offering, the underwriter received warrants to purchase a total of 305,000 shares of the Company’s common stock. The exercise price of the warrants is $2.50 per share; the warrants become exercisable in June 2013 and expire in June 2017.

In November 2012, the Company completed a public offering of securities consisting of 1,946,000 shares of common stock at an offering price of $2.10 per share, generating approximately $3.6 million in total proceeds. Fees and other expenses totaled $445,000, including a underwriter’s fee of 7%. In connection with the offering, the underwriter exercised an over-allotment option to purchase 291,900 additional shares of common stock at $2.10 per share generating approximately $566,000 net of expenses of approximately $47,000.

Under the terms of an agreement for investor relations services, the Company issued a total of 8,334 shares of common stock; 4,167 shares of the total were issued in April 2012, at $4.26 per share and the remaining 4,167 shares were issued in June 2012, at $2.88 per share. The issuance resulted in a total of $29,776 of stock-based compensation being recorded.

2011 Transactions:

In July 2011 at the annual shareholders meeting the Board of Directors approved an amendment to the Company’s Articles of Incorporation to reduce the authorized common shares from 60 million to 30 million.


TABLE OF CONTENTS

Venaxis, Inc.

Notes to Financial Statements

Note 5. Stockholders’ equity:  – (continued)

In December 2011, the Company completed a registered direct offering of securities consisting of 267,500 units for a negotiated price of $6.12 per unit, generating approximately $1,456,000 in net proceeds to the Company. Fees and other expenses totaled $181,000, including a placement fee of 6.79%. Each unit consisted of one share of the Company’s no par value common stock and one warrant to purchase one share of common stock. The exercise price of each warrant is $7.32 per share; the warrants are exercisable beginning June 30, 2012 and expire in June 2017.

2010 Transactions:

In May 2010, the Company completed a registered direct offering of securities consisting of 80,321 units (Units) for a negotiated price of $124.50 per Unit, generating approximately $9,117,000 in net proceeds to the Company. Fees and other expenses totaled $883,000, including a placement fee of 6.5%. Each Unit consisted of one share of the Company’s no par value common stock and one warrant to purchase 0.285 shares of common stock. Accordingly, a total of 80,321 shares of common stock and warrants to purchase 22,892 shares of common stock were issued. The exercise price of the warrants was $144.60 per share; the warrants were exercisable upon issuance for an eight month term and expired in January 2011.

During the year ended December 31, 2010, consultants exercised options outstanding under the Company’s 2002 Stock Incentive Plan (the Plan) as amended and approved by the Company’s shareholders, to purchase 8,702 shares of common stock generating $291,028 in cash proceeds to the Company.

Note 6. Stock options and warrants:

The Company currently provides stock-based compensation to employees, directors and consultants, both under the Company’s 2002 Stock Incentive Plan, as amended (the “Plan”) and non-qualified options and warrants issued outside of the Plan. In 2012, the Company’s shareholders approved amendments to the Plan to increase the number of shares reserved under the Plan from 250,000 to 1,487,205. The Company estimates the fair value of the share-based awards on the date of grant using the Black-Scholes option-pricing model (the “Black-Scholes model”). Using the Black-Scholes model, the value of the award that is ultimately expected to vest is recognized over the requisite service period in the statement of operations. Option forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company attributes compensation to expense using the straight-line single option method for all options granted.

The Company’s determination of the estimated fair value of share-based payment awards on the date of grant is affected by the following variables and assumptions:

The grant date exercise price — the closing market price of the Company’s common stock on the date of the grant;
Estimated option term — based on historical experience with existing option holders;
Estimated dividend rates — based on historical and anticipated dividends over the life of the option;
Term of the option — based on historical experience, grants have lives of approximately 3 – 5 years;
Risk-free interest rates — with maturities that approximate the expected life of the options granted;
Calculated stock price volatility — calculated over the expected life of the options granted, which is calculated based on the daily closing price of the Company’s common stock over a period equal to the expected term of the option; and
Option exercise behaviors — based on actual and projected employee stock option exercises and forfeitures.

TABLE OF CONTENTS

Venaxis, Inc.

Notes to Financial Statements

Note 6. Stock options and warrants:  – (continued)

The Company recognized stock-based compensation during the years ended December 31, as follows:

   
 2012 2011 2010
Stock options to employees, officers, and directors $833,351  $1,200,118  $2,103,276 
Stock options to consultants for:
               
Investor relations activities  23,598   57,309   61,174 
APPY1 activities  38,460   54,304   38,064 
Animal health activities  5,752   24,446   161,357 
Total stock-based compensation $901,161  $1,336,177  $2,363,871 

The above expenses are included in the accompanying Statements of Operations for the years ended December 31, in the following categories:

   
 2012 2011 2010
Selling, general and administrative expenses $862,701  $1,281,873  $2,325,807 
Research and development expenses  38,460   54,304   38,064 
Total stock-based compensation $901,161  $1,336,177  $2,363,871 

Stock incentive plan options:

The Company currently provides stock-based compensation to employees, directors and consultants under the Plan. The Company utilized assumptions in the estimation of fair value of stock-based compensation for the years ended December 31, as follows:

   
 2012 2011 2010
Dividend yield  0  0  0
Expected price volatility  121 to 127  119 to 120  110 to 119
Risk free interest rate  .60 to 1.03  1.32 to 2.14  1.60 to 2.62
Expected term  5 years   5 years   5 years 

A summary of stock option activity under the Plan for options to employees, officers, directors and consultants, for the year ended December 31, 2012, is presented below:

    
 Shares Underlying Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value
Outstanding at January 1, 2012  215,321  $53.94           
Granted  540,378   2.29           
Exercised                
Forfeited  (47,759  61.79       
Outstanding at December 31, 2012  707,940  $13.98   8.8  $228,800 
Exercisable at December 31, 2012  199,505  $40.17   6.2  $16,250 

The aggregate intrinsic value in the table above represents the total intrinsic value (the difference between the Company’s closing stock price on December 31, 2012 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders, had all option holders been able to, and in fact had, exercised their options on December 31, 2012.

During the year ended December 31, 2012, 540,378 options were granted under the Plan to employees, officers, directors and consultants with a weighted average exercise price at grant date of $2.29 per option. Included in the 540,378 options issued, the independent directors were granted a total of 151,992 options at an


TABLE OF CONTENTS

Venaxis, Inc.

Notes to Financial Statements

Note 6. Stock options and warrants:  – (continued)

average exercise price of $2.28 per share; 12,502 of these director options were granted at an exercise price of $4.26 per share, vesting over a three year period annually in arrears and 139,490 director options were granted at an exercise price of $2.10 per share vesting after one year. Officers were granted a total of 301,362 options at an average exercise price of $2.29 per share; 40,668 officer options were granted at an average exercise price of $3.50 per share, vesting over a twelve month period following grant and 260,694 officer options were granted at an exercise price of $2.10 per share, vesting after one year. Employees were granted a total of 62,024 options at an average exercise price of $2.46 per share, 11,142 employee options at an average exercise price of $4.11 per share which vest over a twelve month period following grant and 50,882 options were granted at an exercise price of $2.10 per share, vesting after one year. Substantially all of the grants to officers and employees were awarded as retention incentive options. The Company also issued 25,000 options to a consultant at an exercise price of $1.91 per share, vesting after ninety days. All options granted under the Company’s 2002 Stock Incentive Plan expire ten years from the grant date.

During the year ended December 31 2012, a total of 47,759 options that were granted under the Plan to directors, employees, including an officer, and consultants were forfeited, 23,283 of which were vested and 24,476 were unvested. The options were exercisable at an average of $61.79 per share and were forfeited upon the employees’ termination from the Company. During the year ended December 31, 2012, no options were exercised.

During the year ended December 31, 2011, 52,267 stock options were granted under the Plan to employees, officers, directors, and consultants with a weighted average fair value at the grant date of $19.14 per option. Included in the 52,267 options issued, existing directors and officers were granted a total of 40,834 options at an exercise price of $19.02 per share and existing employees were granted 4,317 options at an exercise price of $18.30 per share, all vesting over a three-year period annually in arrears and expiring in ten years. Four newly hired employees were granted a total of 450 options at $19.86 per share, all vesting over a three-year period annually in arrears and expiring in ten years. The Company also issued 6,667 non-qualified options to a consultant at an exercise price of $20.40 per share which expire in ten years. These non-qualified options are performance related with vesting tied to achieving specificAPPY1 clinical and regulatory milestones. During the year ended December 31, 2011, no options were exercised.

During the year ended December 31, 2011, a total of 20,912 options granted under the Plan were forfeited, 11,402 of which were vested and 9,510 which were unvested. The options were exercisable at an average of $52.50 per share and were forfeited upon the employees’, officers and consultant’s termination from the Company. During the year ended December 31, 2010, a total of 1,523 options were forfeited, 445 of which were vested and 1,078 were unvested. The options were exercisable at an average of $79.50 per share and were forfeited upon the employees’ terminations from the Company.

During the year ended December 31, 2010, 46,600 stock options were granted under the Plan to employees, officers, directors and consultants with a weighted average fair value at the grant date of $51.30 per option. During the year ended December 31, 2010, consultants exercised 8,702 options outstanding under the Company’s Plan generating $291,028 in cash and which had an intrinsic value when exercised of $371,130.

The total fair value of stock options granted to employees, directors and consultants that vested and became exercisable during the years ended December 31, 2012, 2011 and 2010, was $1,486,000, $2,063,000 and $2,327,000, respectively. Based upon the Company’s experience, approximately 85% of the outstanding stock options, or approximately 432,000 options, are expected to vest in the future, under their terms. A summary of the activity of non-vested options under the Company’s Plan to acquire common shares granted to employees, officers, directors and consultants during the year ended December 31, 2012 is presented below:


TABLE OF CONTENTS

Venaxis, Inc.

Notes to Financial Statements

Note 6. Stock options and warrants:  – (continued)

   
Nonvested Shares Nonvested Shares Underlying Options Weighted Average Exercise Price Weighted Average Grant Date Fair Value
Nonvested at January 1, 2012  88,986  $35.64  $28.98 
Granted  540,378   2.29   1.92 
Vested  (96,453  18.92   15.40 
Forfeited  (24,476  28.58   23.35 
Nonvested at December 31, 2012  508,435  $3.70  $3.07 

At December 31, 2012, based upon employee, officer, director and consultant options granted to that point, there was $4,709approximately $914,000 additional unrecognized compensation cost related to stock options that will be recorded over a weighted average future period of approximately one year.

Effective as of January 1, 2013, in connection with the addition of a new director, 48,000 stock options were issued to the director, under the Plan, exercisable at $2.56 per share. The options expire ten years from date of grant and vest as to 50% of the total over three years, annually in arrears and the remaining 50% commencing quarterly in advance upon the grant date over the following four quarters. During January 2013, in connection with its annual option grant award cycle, 426,270 options were issued under the Plan to directors, officers and employees, at an exercise price of $2.04 per share. The options expire ten years from date of grant and vest as to non-employee directors quarterly in advance over four quarters and as to officers, and employees 50% upon the six month anniversary of grant date and the balance equally over the following six quarters in arrears. Subsequent to December 31, 2012, 6,582 options related to employee terminations expired which were exercisable at an average of $2.42 per share.

Other common stock purchase options and warrants:

As of December 31, 2012, in addition to the stock incentive plan options discussed above, the Company had 598,507 non-qualified options and warrants outstanding in connection with offering warrants, an officer’s employment and investor relations consulting.

The Company utilized assumptions in the estimation of the fair value of stock-based compensation for the years ended December 31, as follows:

   
 2012 2011 2010
Dividend yield  0  0  0
Expected price volatility  121  119 to 145  128 to 130
Risk free interest rate  0.74  1.20 to 1.95  1.26 to 1.70
Contractual term  5 years   3 to 10 years   3 years 

Operating expenses for the years ended December 31, 2012, 2011 and 2010, include approximately $71,000, $92,000 and $61,000, respectively, related to non-qualified options and warrants.


TABLE OF CONTENTS

Venaxis, Inc.

Notes to Financial Statements

Note 6. Stock options and warrants:  – (continued)

Following is a summary of outstanding options and warrants that were issued outside of the Plan for the year ended December 31, 2012:

    
 Shares Underlying Options/ Warrants Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value
Outstanding at January 1, 2012  282,178  $8.70           
Granted  325,000   2.56           
Exercised                
Forfeited  (8,671  33.44       
Outstanding at December 31, 2012  598,507  $5.01   4.6  $18,300 
Exercisable at December 31, 2012  285,174  $7.74   4.6  $ 

The aggregate intrinsic value in the table above represents the total intrinsic value (the difference between the Company’s closing stock price on December 31, 2012 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders, had all option holders been able to, and in fact had, exercised their options on December 31, 2012.

In June 2012, the Company completed a $12.2 million public offering of securities and in connection with that offering, granted the Underwriter warrants to purchase a total of 305,000 shares of common stock. These warrants which are included in the above table are not exercisable until June 2013 at an exercise price of $2.50 per share, and expire in June 2017. Included at December 31, 2012 in the 598,507 total outstanding options and warrants are 572,505 non-compensatory rights granted in connection with public offerings and 26,002 rights issued under compensatory arrangements.

During the year ended December 31, 2012, the Company hired a Senior Vice President and Chief Commercial Officer who previously had a consulting relationship with the Company. As part of the employment arrangement, the Board of Directors approved an employment-inducement grant made outside of the Company’s Plan, and granted 20,000 options which are exercisable at $3.42 per share. The options vest as to 50% of the total on the six month anniversary following the grant date and the remaining 50% vesting one-sixth monthly over months seven through twelve following the grant date. The options expire ten years from the grant date. During the year ended December 31, 2012, 2,004 vested options previously granted to an investor relations firm expired.

During the year ended December 31, 2011, the Company hired a Vice President of Marketing and Business who previously had a consulting relationship with the Company. As part of the employment arrangement, the Board approved an employment-inducement grant made outside of the Company’s Stock 2002 Incentive Plan, and he was granted 6,667 options for services which are exercisable at $19.50 per share. The options were scheduled to vest equally over a three year period however they were forfeited upon the officer’s termination from the Company in 2012. Also, during the year ended December 31, 2011, an investor relations firm was granted 5,000 warrants to purchase shares of common stock scheduled to vest equally over twelve months from the date of grant and are exercisable at $30.00 per share and expire in three years. During the year ended December 31, 2011, 4,584 investor relations consultant options expired of which 1,500 were exercisable at $360.00 per share, 1,251 options were exercisable at $180.30 per share, 1,667 options were exercisable at $167.10 per share and 166 options at $ $149.70 per share. In addition 22,892 warrants granted at $144.60 per share in connection with the 2010 public registered direct offering expired.

During the year ended December 31, 2010, 23,892 stock options and warrants were granted to an investor relations firm and under a registered direct offering with a weighted average fair value at the grant date of $141.00 per option.


TABLE OF CONTENTS

Venaxis, Inc.

Notes to Financial Statements

Note 6. Stock options and warrants:  – (continued)

During the years ended December 31, 2012, 2011 and 2010, no options granted outside of the Plan were exercised.

The total fair value of stock options granted to an investor relations consulting firm that vested and became exercisable during the years ended December 31, 2012, 2011 and 2010, was $89,000, $61,000 and $61,000, respectively.

A summary of the activity of nonvested, non-qualified options and warrants granted outside of the Plan in connection with employment and investor relations consulting services for the year ended December 31, 2012, is presented below:

   
Nonvested Shares Nonvested Shares Underlying Options Weighted Average Exercise Price Weighted Average Grant Date Fair Value
Nonvested at January 1, 2012  7,917  $21.18  $16.14 
Granted  20,000   3.42   2.84 
Vested  (15,137  7.97   5.89 
Forfeited  (4,447  19.50   16.11 
Nonvested at December 31, 2012  8,333  $3.42  $2.84 

At December 31, 2012, there was approximately $22,000 in unrecognized cost for non-qualified options that will be recorded over a weighted average future period of less than one year.

Subsequent to December 31, 2012, 501 investor relations options which were exercisable at $54.00 per share expired.

Note 7. Animal Health License Agreements:

Effective May 1, 2004 Washington University in St. Louis (WU) and Venaxis entered into an Exclusive License Agreement (WU License Agreement) which grants Venaxis exclusive license and right to sublicense WU’s technology (as defined under the WU License Agreement) for veterinary products worldwide, except where such products are prohibited under U.S. laws for export. The term of the WU License Agreement continues until the expiration of the last of WU’s patents (as defined in the WU License Agreement) expire. Venaxis has agreed to pay minimum annual royalties of $20,000 annually during the term of the WU License Agreement and such amounts are creditable against future royalties. Royalties payable to WU under the WU License Agreement for covered product sales by Venaxis carry a mid-single digit royalty rate and for sublicense fees received by Venaxis carry a low double-digit royalty rate. The WU License Agreement contains customary terms for confidentiality, prosecution and infringement provisions for licensed patents, publication rights, indemnification and insurance coverage. The WU License Agreement is cancelable by Venaxis with ninety days advance notice at any time and by WU with sixty days advance notice if Venaxis materially breaches the WU License Agreement and fails to cure such breach.

In July 2012, the Company entered into an Exclusive License Agreement (the “License Agreement”) with a licensee (“Licensee”), under which the Company granted the Licensee an exclusive royalty-bearing license to the Company’s intellectual property and other assets, including patent rights and know-how, relating to recombinant single chain reproductive hormone technology for use in non-human mammals (the “Company’s Animal Health Assets”). The License Agreement includes a sublicense of the technology licensed to the Company by WU. Under the terms of the WU License Agreement, a portion of license fees and royalties Venaxis receives from sublicensing agreements will be paid to WU. The obligation for such license fees due to WU is included in accrued expenses at December 31, 2012.

Under the License Agreement, the Licensee obtained a worldwide exclusive license to develop, seek regulatory approval for and offer to sell, market, distribute, import and export luteinizing hormone (“LH”)


TABLE OF CONTENTS

Venaxis, Inc.

Notes to Financial Statements

Note 7. Animal Health License Agreements:  – (continued)

and/or follicle-stimulating hormone (“FSH”) products for bovine (cattle), equine and swine in the field of the assistance and facilitation of reproduction in bovine, equine and swine animals. The Company also granted the Licensee an option and right of first refusal to develop additional animal health products outside of the licensed field of use or any diagnostic pregnancy detection tests for non-human mammals.

Under the License Agreement as of December 31, 2012, the following future license fees and milestone payments are provided, assuming future milestones are successfully achieved:

License fees of $408,000 payable in quarterly installments of $204,000;
Milestone payments, totaling up to a potential of $1.1 million in the aggregate, based on the satisfactory conclusion of milestones as defined in the License Agreement;
Potential for milestone payments of up to an additional $2 million for development and receipt of regulatory approval for additional licensed products; and
Royalties, at low double digit rates, based on sales of licensed products.

Revenue recognition related to the License Agreement and WU Agreement is based primarily on the Company’s consideration of ASC 808-10-45, “Accounting for Collaborative Arrangements”. For financial reporting purposes, the license fees and milestone payments received from the License Agreement, net of the amounts due to third parties, including WU, have been recorded as deferred revenue and are amortized over the term of the License Agreement. License fees and milestone revenue totaling a net of approximately $1,182,000 commenced being amortized into income upon the July 2012 date of milestone achievement. As of December 31, 2012, deferred revenue of $79,803 has been classified as a current liability and $1,081,706 has been classified as a long-term liability. The current liability includes the next twelve months’ portion of the amortizable milestone revenue. During the year ended December 31, 2012, $20,571 was recorded as the amortized license fee revenue arising from the License Agreement.

A tabular summary of the revenue categories and amounts of revenue recognition associated with the License Agreement follows:

 
Category Totals
License fees and milestone amounts paid/achieved $1,512,000 
Third party obligations recorded, including WU  (329,920
Deferred revenue balance  1,182,080 
Revenue amortization to December 31, 2012  (20,571
Net deferred revenue balance at December 31, 2012 $1,161,509 

CategoryTotals
Commencement of license fees revenue recognitionUpon signing or receipt
Commencement of milestone revenue recognitionUpon milestone achievement over then remaining life
Original amortization period197 months

The animal health technology, licensed from WU in 2004 was sub-licensed in 2008 to Novartis Animal Health (“Novartis”) under a long-term world-wide development and marketing agreement. In November 2011, the Company entered into a Termination Agreement with Novartis Animal Health, Inc. (the “Novartis Termination Agreement”) to terminate the Novartis License Agreement. Under the Novartis Termination Agreement, the original termination obligation totaled $1,374,000, which was payable $150,000 upon signing the Novartis Termination Agreement and six equal subsequent quarterly installments of $204,000 each. At December 31, 2012, the remaining outstanding termination obligation totaled $397,588 which is due in 2013. Between 2008 and 2011, the Company received up-front license fees which were recorded, net of the amounts due to WU, in accordance with ASC 808. The non-refundable net amount of $810,000 was being amortized to license fee


TABLE OF CONTENTS

Venaxis, Inc.

Notes to Financial Statements

Note 7. Animal Health License Agreements:  – (continued)

revenue over the 152 month original license period. During the years ended December 31, 2011 and 2010, $62,179 and $68,394, respectively, was recorded as the amortized license fee revenue arising from the Novartis License Agreement. Upon execution of the Termination Agreement with Novartis, the Company recorded a gain of $938,896, arising from the elimination of both the $900,000 in remaining deferred revenue and the net accounts payable to Novartis the total of which exceeded the net settlement obligation to Novartis. As of the date of termination, future amortization of the deferred revenue was terminated.

Note 8. Other income:

In 2010, the Company received $244,479 from the U.S. Department of Treasury under the qualifying therapeutic discovery project under Section 48D of the Internal Revenue Code which is included in other income for the year ended December 31, 2010.

Note 9. Income taxes:

Income taxes at the federal statutory rate are reconciled to the Company’s actual income taxes as follows:

   
 2012 2011 2010
Federal income tax benefit at 34% $(3,132,000 $(3,473,000 $(4,535,000
State income tax net of federal tax effect  (276,000  (306,000  (400,000
Permanent items  339,000   504,000   881,000 
Other  121,000       
Valuation allowance  2,948,000   3,275,000   4,054,000 
   $  $  $ 

As of December 31, 2012, the Company has net operating loss carry forwards of approximately $68 million for federal and state tax purposes, which are available to offset future taxable income, if any, expiring through December 2032. A valuation allowance was recorded at December 31, 2012 due to the uncertainty of realization of deferred tax assets in the future.

The tax effects of temporary differences that give rise to significant portions of deferred tax assets and liabilities at December 31, 2012 and 2011 are as follows:

20122011
Deferred tax assets (liabilities):
Net operating loss carry forwards$25,100,000$22,767,000
Property and equipment32,0008,000
Patents and other intangible assets17,00023,000
Other15,000
Deferred revenue551,000
Research and development credit753,000692,000
Deferred tax asset26,453,00023,505,000
Valuation allowance(26,453,000(23,505,000
$$

TABLE OF CONTENTS

Venaxis, Inc.

Notes to Financial Statements

Note 10. Commitments and contingencies:

Commitments:

Employment commitments:

As of December 31, 2012, the Company has employment agreements with three officers providing aggregate annual minimum commitments totaling $780,000. The agreements automatically renew at the end of each year unless terminated by either party and contain customary confidentiality and benefit provisions.

Contingencies:

On September 1, 2010, the Company received a complaint, captioned Mark Chipman v. AspenBio Pharma, Inc. (now Venaxis, Inc.), Case No. 2:10-cv-06537-GW-JC (“Chipman Suit”). The complaint was filed in the U.S. District Court in the Central District of California by an individual investor. The complaint included allegations of fraud, negligent misrepresentation, violations of Section 10(b) of the Exchange Act and SEC Rule 10b-5, and violations of Sections 25400 and 25500 of the California Corporations Code, all related to the Company’s blood-based acute appendicitis test in development. On the Company’s motion, the action was transferred to the U.S. District Court for the District of Colorado by order dated January 21, 2011. The action was assigned a District of Colorado Civil Case No. 11-cv-00163-REB-KMT.

On October 7, 2011, the Company filed a motion to dismiss the complaint. On September 17, 2012, the United States District Court for Colorado granted the Company’s motion to dismiss, dismissing the plaintiff’s claims against the Company without prejudice. On the same day, the court also entered final judgment without prejudice in favor of the Company and against the plaintiff in the Chipman Suit. The plaintiff in the Chipman Suit did not file a Notice of Appeal.

On October 1, 2010, the Company received a complaint, captioned John Wolfe, individually and on behalf of all others similarly situated v. AspenBio Pharma, Inc. (now Venaxis, Inc.) et al., Case No. CV10 7365 (“Wolfe Suit”). This federal securities purported class action was filed in the U.S. District Court in the Central District of California on behalf of all persons, other than the defendants, who purchased common stock of the Company during the period between February 22, 2007 and July 19, 2010, inclusive. The complaint named as defendants certain officers and directors of the Company during such period. The complaint included allegations of violations of Section 10(b) of the Exchange Act and SEC Rule 10b-5 against all defendants, and of Section 20(a) of the Exchange Act against the individual defendants, all related to the Company’s blood-based acute appendicitis test in development known asAPPY1. On the Company’s motion, this action was also transferred to the U.S. District Court for the District of Colorado by order dated January 21, 2011. The action has been assigned a District of Colorado Civil Case No. 11-cv-00165-REB-KMT. On July 11, 2011, the court appointed a lead plaintiff and approved lead counsel. On August 23, 2011, the lead plaintiff filed an amended putative class action complaint, alleging the same class period. Based on a review of the amended complaint, the Company and the individual defendants believe that the plaintiffs’ allegations are without merit, have vigorously defended against these claims, and intend to continue to do so.

On October 7, 2011, the Company filed a motion to dismiss the amended complaint, and the plaintiff’s response and the Company’s reply thereto were subsequently filed. On September 13, 2012, the United States District Court for Colorado granted the Company’s motion to dismiss, dismissing the plaintiffs’ claims against all defendants without prejudice. On September 14, 2012, the court entered Final Judgment without prejudice on behalf of all defendants and against all plaintiffs in the Wolfe Suit. The Order to dismiss the action found in favor of the company and all of the individual defendants. On October 12, 2012, the plaintiffs filed a Notice of Appeal of the Order granting the motion to dismiss and of the Final Judgment in the Wolfe Suit. The plaintiffs filed their opening brief with the Tenth Circuit Court of Appeals on March 1, 2013.

On January 4, 2011, a plaintiff filed a complaint in the U.S. District Court for the District of Colorado captioned Frank Trpisovsky v. Pusey, et al, Civil Action No. 11-cv-00023-PAB-BNB, that purports to be a shareholder derivative action on behalf of the Company against thirteen individual current or former officers


TABLE OF CONTENTS

Venaxis, Inc.

Notes to Financial Statements

Note 10. Commitments and contingencies:  – (continued)

and directors. The complaint also names the Company as a nominal defendant. The plaintiff asserts violations of Section 14(a) of the Exchange Act, SEC Rule 14a-9, breach of fiduciary duty, waste of corporate assets, and unjust enrichment. On motion of the Company and the individual defendants, the U.S. District Court has stayed this derivative action by order dated March 15, 2011, and this action continues to be stayed. On October 18, 2012, the parties filed a Joint Status Report, reporting on updates in the Chipman Suit and the Wolfe Suit and stating that the stay should remain in place at this time and that a further status report should be submitted after appeals in the Wolfe Suit have been resolved. On October 25, 2012, the magistrate judge issued a recommendation that the case be administratively closed, subject to reopening for good cause. The U.S. District Court on November 14, 2012, accepted the recommendation and ordered this action administratively closed, subject to reopening for good cause.

In the ordinary course of business and in the general industry in which the Company is engaged, it is not atypical to periodically receive a third party communication which may be in the form of a notice, threat, or ‘cease and desist’ letter concerning certain activities. For example, this can occur in the context of the Company’s pursuit of intellectual property rights. This can also occur in the context of operations such as the using, making, having made, selling, and offering to sell products and services, and in other contexts. The Company makes rational assessment of each situation on a case-by-case basis as such may arise. The Company periodically evaluates its options for trademark positions and considers a full spectrum of alternatives for trademark protection and product branding.

Note 11. Supplemental data: Selected quarterly financial information (unaudited)

    
 March 31, June 30, September 30, December 31,
Fiscal 2012 quarters ended:
                    
Total revenues $7,000  $27,000  $6,000  $2,000 
Gross margin $7,000  $27,000  $6,000  $1,000 
Net loss $(1,938,000 $(2,310,000 $(2,460,000 $(2,504,000
Loss per share – Basic and diluted $(1.20 $(1.19 $(.32 $(0.87
Market price of common stock
                    
High $5.88  $4.44  $2.77  $2.93 
Low $3.90  $1.88  $1.33  $2.04 
Fiscal 2011 quarters ended:
                    
Total revenues $97,000  $55,000  $22,000  $45,000 
Gross margin $85,000  $52,000  $22,000  $44,000 
Net loss $(2,806,000 $(2,787,000 $(3,064,000 $(1,557,000
Loss per share – Basic and diluted $(2.10 $(2.10 $(2.28 $(0.96
Market price of common stock
                    
High $25.50  $23.61  $22.50  $17.53 
Low $16.80  $18.60  $14.40  $5.82 

TABLE OF CONTENTS

Venaxis, Inc.

Balance Sheets

  
 March 31,
2013
(Unaudited)
 December 31,
2012
ASSETS
          
Current assets:
          
Cash and cash equivalents $2,491,838  $10,977,974 
Short-term investments (Note 1)  6,775,800   1,162,904 
Prepaid expenses and other current assets  286,761   387,480 
Total current assets  9,554,399   12,528,358 
Property and equipment, net (Note 2)  2,428,789   2,484,539 
Other long term assets, net (Notes 1 and 3)  1,610,964   1,601,894 
Total assets $13,594,152  $16,614,791 
LIABILITIES AND STOCKHOLDERS' EQUITY
          
Current liabilities:
          
Accounts payable $704,782  $613,925 
Accrued compensation  31,695   452,878 
Accrued expenses  452,749   642,055 
Notes and other obligations, current portion (Note 4)  1,945,383   2,290,292 
Deferred revenue, current portion (Note 7)  84,995   79,803 
Total current liabilities  3,219,604   4,078,953 
Notes and other obligations, less current portion (Note 4)  746,776   763,132 
Deferred revenue, less current portion (Note 7)  1,254,719   1,081,706 
Total liabilities  5,221,099   5,923,791 
Commitments and contingencies (Notes 7 and 8)
          
Stockholders' equity (Notes 5 and 6):
          
Common stock, no par value, 30,000,000 shares authorized;
9,954,380 shares issued and outstanding
  85,408,355   84,924,133 
Accumulated deficit  (77,035,302  (74,233,133
Total stockholders' equity  8,373,053   10,691,000 
Total liabilities and stockholders' equity $13,594,152  $16,614,791 



See Accompanying Notes to Unaudited Condensed Financial Statements


TABLE OF CONTENTS

Venaxis, Inc.

Statements of Operations
Three Months Ended March 31
(Unaudited)

  
 2013 2012
Sales $  $7,275 
Cost of sales     184 
Gross profit     7,091 
Other revenue – fee (Note 7)  18,655    
Operating expenses:
          
Selling, general and administrative  1,427,955   1,204,675 
Research and development  1,411,973   676,618 
Total operating expenses  2,839,928   1,881,293 
Operating loss  (2,821,273  (1,874,202
Other income (expense), net  19,104   (64,069
Net loss $(2,802,169 $(1,938,271
Basic and diluted net loss per share (Note 1) $(0.28 $(1.21
Basic and diluted weighted average number of shares outstanding (Note 1)  9,954,380   1,608,146 



See Accompanying Notes to Unaudited Condensed Financial Statements


TABLE OF CONTENTS

Venaxis, Inc.

Statements of Cash Flows
Three Months Ended March 31
(Unaudited)

  
 2013 2012
Cash flows from operating activities:
          
Net loss $(2,802,169 $(1,938,271
Adjustments to reconcile net loss to net cash used in operating activities:
          
Stock-based compensation for services  484,222   221,996 
Depreciation and amortization  86,808   112,325 
Impairment charges     41,950 
Amortization of license fees  (18,655) )    
Change in:
          
Accounts payable  90,857   (121,135
Accounts receivable     28,028 
Prepaid expenses and other current assets  100,719   109,043 
Deferred revenue  196,860    
Accrued compensation  (421,183 )    
Accrued expenses  (189,306  (188,522
Net cash used in operating activities  (2,471,847  (1,734,586
Cash flows from investing activities:
          
Purchases of short-term investments  (5,612,896   
Sales of short-term investments     441,346 
Purchases of property and equipment  (10,844   
Purchases of patent and trademark application costs  (29,284  (23,099
Net cash provided by investing activities  (5,653,024 )   418,247 
Cash flows from financing activities:
          
Repayment of notes payable and other obligations  (361,265  (335,303
Net cash used in financing activities  (361,265  (335,303
Net decrease in cash and cash equivalents  (8,486,136 )   (1,651,642
Cash and cash equivalents at beginning of period  10,977,974   2,968,104 
Cash and cash equivalents at end of period $2,491,838  $1,316,462 
Supplemental disclosure of cash flow information:
          
Cash paid during the period for interest $47,120  $64,768 



See Accompanying Notes to Unaudited Condensed Financial Statements


TABLE OF CONTENTS

Venaxis, Inc.

Notes to Condensed Financial Statements
(Unaudited)

INTERIM FINANCIAL STATEMENTS

The accompanying financial statements of Venaxis, Inc. (the “Company,” “we,” or “Venaxis”) have been prepared in accordance with the instructions to quarterly reports on Form 10-Q. In the opinion of management, all adjustments (which include only normal recurring adjustments) necessary to present fairly the financial position, results of operations and changes in financial position at March 31, 2013 and for all periods presented have been made. Certain information and footnote data necessary for fair presentation of financial position and results of operations in conformity with accounting principles generally accepted in the United States of America have been condensed or omitted. It is therefore suggested that these financial statements be read in conjunction with the summary of significant accounting policies and notes to financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012. The results of operations for the period ended March 31, 2013 are not necessarily an indication of operating results for the full year.

Management’s plans and basis of presentation:

The Company has experienced recurring losses and negative cash flows from operations. At March 31, 2013, the Company had approximate balances of cash and liquid investments of $9,268,000, working capital of $6,335,000, stockholders’ equity of $8,373,000 and an accumulated deficit of $77,035,000. To date, the Company has in large part relied on equity financing to fund its operations. The Company expects to continue to incur losses from operations for the near-term and these losses could be significant as product development, clinical and regulatory activities, consulting expenses and other product development related expenses are incurred. The Company believes that its current working capital position will be sufficient to meet its estimated cash needs for the remainder of 2013 and at least into 2014. If the Company does not obtain additional capital, the Company would potentially be required to reduce the scope of its research and development activities or cease operations. The Company continues to explore obtaining additional financing. The Company is closely monitoring its cash balances, cash needs and expense levels. In addition, the Company’s first mortgage which is held by a commercial bank requires a balloon payment of approximately $1.6 million due in July, 2013. Subsequent to March 31, 2013, the Company received a loan commitment to refinance the commercial bank obligation (Note 4).

Management’s strategic plans include the following:

continuing to advance development of the Company’s principal product,APPY1;
pursuing additional capital raising opportunities;
continuing to explore prospective partnering or licensing opportunities with complementary opportunities and technologies;
continuing to monitor and implement cost control initiatives to conserve cash; and
refinancing the portion of the mortgage payable in July 2013.

Note 1. Significant accounting policies:

Cash, cash equivalents and investments:

The Company considers all highly liquid investments with an original maturity of three months or less at the date of acquisition to be cash equivalents. From time to time, the Company’s cash account balances exceed the balances as covered by the Federal Deposit Insurance System. The Company has never suffered a loss due to such excess balances.

The Company invests excess cash from time to time in highly-liquid debt and equity investments of highly-rated entities which are classified as trading securities. The purpose of the investments is to fund research and development, product development, United States Food and Drug Administration (“FDA”) clearance-related activities and general corporate purposes. Such amounts are recorded at market values using Level 1 inputs in


TABLE OF CONTENTS

Venaxis, Inc.

Notes to Condensed Financial Statements
(Unaudited)

Note 1. Significant accounting policies:  – (continued)

determining fair value and are classified as current, as the Company does not intend to hold the investments beyond twelve months. Investment securities classified as trading are those securities that are bought and held principally for the purpose of selling them in the near term, with the objective of preserving principal and generating profits. These securities are reported at fair value with unrealized gains and losses reported as an element of other (expense) income in current period earnings. The Company’s Board of Directors has approved an investment policy covering the investment parameters to be followed with the primary goals being the safety of principal amounts and maintaining liquidity of the fund. The policy provides for minimum investment rating requirements as well as limitations on investment duration and concentrations. Based upon market conditions, the investment guidelines have been tightened to increase the minimum acceptable investment ratings required for investments and shorten the maximum investment term. As of March 31, 2013, 24% of the investment portfolio was in cash and cash equivalents, which is presented as such on the accompanying balance sheet, and the remaining funds were invested in short-term marketable securities with none individually representing more than 5% of the portfolio and none with maturities past January 2014. To date, the Company’s cumulative realized market loss from the investments has not been in excess of $5,000. For the three months ended March 31, 2013, there was approximately $38,869 in unrealized income, there wasloss, no realized gain or loss, and $18,271$3,893 in management fees. For the three months ended March 31, 2012, there was approximately $1,260 in unrealized income, no realized gain or loss, and $657 in management fees.

Fair value of financial instruments:

The Company accounts for financial instruments under Financial Accounting Standards Board (FASB) Accounting Standards Codification Topic (ASC) 820, (formerly Statement of Financial Accounting Standard (SFAS) No. 157),Fair Value Measurements. This statement defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles, and expands disclosures about fair value measurements. To increase consistency and comparability in fair value measurements, ASC 820 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels as follows:

Level 1 — quoted prices (unadjusted) in active markets for identical assets or liabilities;

Level 2 — observable inputs other than Level 1, quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, and model-derived prices whose inputs are observable or whose significant value drivers are observable; and

Level 3 — assets and liabilities whose significant value drivers are unobservable.

Observable inputs are based on market data obtained from independent sources, while unobservable inputs are based on the Company’s market assumptions. Unobservable inputs require significant management judgment or estimation. In some cases, the inputs used to measure an asset or liability may fall into different levels of the fair value hierarchy. In those instances, the fair value measurement is required to be classified using the lowest level of input that is significant to the fair value measurement. Such determination requires significant management judgment. There were no financial assets or liabilities measured at fair value, with the exception of cash, cash equivalents and short-term investments as of DecemberMarch 31, 20112013 and December 31, 2010.2012.

The carrying amounts of the Company’s financial instruments (other than cash, cash equivalents and short-term investments as discussed above) approximate fair value because of their variable interest rates and / and/or short maturities combined with the recent historical interest rate levels.


F-8


 

TABLE OF CONTENTS

AspenBio Pharma,Venaxis, Inc.
 
Notes to Condensed Financial Statements
(Unaudited)

Note 1. Organization and summary of significantSignificant accounting policies:  - (continued)

Revenue recognitionRecently issued and accounts receivable:adopted accounting pronouncements:

The Company recognizes revenue when product is shipped or delivered depending upon the terms of sale. The Company extends credit to customers generally without requiring collateral. Historically, the Company’s base antigen business has sold products primarily throughout North America. One European customer accounted for approximately 3%, 4%,evaluated all recently issued accounting pronouncements and 3% of net sales during 2011, 2010 and 2009, respectively. At December 31, 2011, two customers accounted for 73% and 19% of total accounts receivable. At December 31, 2010, two customers accounted for 82% and 13% of total accounts receivable. During the year ended December 31, 2011, two customers accounted forbelieves such pronouncements do not have a total of 42% of net sales, each representing 28% and 14%, respectively. During the year ended December 31, 2010, four customers accounted for a total of 58% of net sales, each representing 19%, 18%, 11% and 10%, respectively. During the year ended December 31, 2009, two customers accounted for a total of 37% of net sales, each representing 20% and 17%, respectively.

Revenue is recognized under development and distribution agreements only after the following criteria are met: (i) there exists adequate evidence of the transactions; (ii) delivery of goods has occurred or services have been rendered; and (iii) the price is not contingent on future activity and (iv) collectability is reasonably assured.

The Company monitors its exposure for credit losses and maintains allowances for anticipated losses. The Company records an allowance for doubtful accounts when it is probable that the accounts receivable balance will not be collected. When estimating the allowance, the Company takes into consideration such factors as its day-to-day knowledge of the financial position of specific clients, the industry and size of its clients. A financial decline of any one of the Company’s large clients could have an adverse and material effect on the collectability of receivables and thus the adequacy of the allowance for doubtful accounts receivable. Increases in the allowance are recorded as charges to bad debt expense and are reflected in other operating expenses in the Company’s statements of operations. Write-offs of uncollectible accounts are charged against the allowance. No allowance was considered necessary at December 31, 2011 or 2010.

Property and equipment:

Property and equipment is stated at cost and depreciated using the straight-line method over the estimated useful lives of the assets, generally twenty-five years for the building, ten years for land improvements, five years for equipment and three years for computer related assets.

Goodwill and other intangible assets:

Goodwill, arose from the initial formation of the Company, and represents the purchase price paid and liabilities assumed in excess of the fair market value of tangible assets acquired. The Company performs a goodwill impairment test in the fourth quarter of each year and has determined that there has been no goodwill impairment. The Company reviews for impairment at least annually, or whenever there is an indication of impairment.

Impairment of long-lived assets:

Management reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to undiscounted future cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. Based on its review, including an updated assessment subsequent to year end, management determined that certain costs previously incurred for patents had been impaired during the years ended December 31, 2011 and 2010. Approximately $275,000, $107,000 and $565,000 of such patent costs were determined to be impaired during the years ended December 31, 2011, 2010 and 2009, respectively resulting from management’s decisions not to pursue patents based upon a cost benefit analysis of patent expenses and coverage protection

F-9


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Financial Statements

Note 1. Organization and summary of significant accounting policies: - (continued)

in several smaller world markets that were determined to not have the economic or fiscal potential to make the patent pursuit viable. Impairment charges are included in research and development expenses in the accompanying statement of operations.

Research and development:

Research and development costs are charged to expense as incurred.

Use of estimates:

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (GAAP) requires management to make estimates and assumptions that affect reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the balance sheet and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ significantly from those estimates.

Income taxes:

The Company accounts for income taxes under the asset and liability method, in which deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. A valuation allowance is required to the extent any deferred tax assets may not be realizable.

The Company does not have an accrual for uncertain tax positions as of December 31, 2011 and 2010. The Company files corporate income tax returns with the Internal Revenue Service and the State of Colorado, and there are open statutes of limitations for tax authorities to audit the Company’s tax returns from 2008 through the current period.

Stock-based compensation:

AspenBio Pharma accounts for stock-based compensation under ASC 718 (formerly — SFAS No. 123 (revised 2004)),Share-Based Payment. ASC 718 requires the recognition of the cost of employee services received in exchange for an award of equity instruments in the financial statements and is measured based on the grant date fair value of the award. ASC 718 also requires the stock option compensation expense to be recognized over the period during which an employee is required to provide service in exchange for the award (generally the vesting period). The Company estimates the fair value of each stock option at the grant date by using the Black-Scholes option pricing model.statements.

Income (loss) per share:

ASC 260,Earnings Per Share, requires dual presentation of basic and diluted earnings per share (EPS) with a reconciliation of the numerator and denominator of the basic EPS computation to the numerator and denominator of the diluted EPS computation. Basic EPS excludes dilution. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity.

Basic net earnings (loss) per share includes no dilution and is computed by dividing net earnings (loss) available to stockholdersshareholders by the weighted average number of common shares outstanding for the period. The increase in the weighted average number of common shares outstanding in the period ended March 31, 2013, as compared to the same 2012 period resulted from common share issuances in 2012 subsequent to March 31, 2012. Diluted net earnings (loss) per share reflect the potential dilution of securities that could share in the Company’s earnings (loss). The effect of the inclusion of the dilutive shares would have resulted in a decrease in loss per share. Accordingly, the weighted average shares outstanding have not been adjusted for dilutive shares. Outstanding

F-10


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Financial Statements

Note 1. Organization and summary of significant accounting policies: - (continued)

stock options and warrants are not considered in the calculation, as the impact of the potential common shares (totaling approximately 2,984,000, 1,286,0001,774,000 shares and 952,0002,862,000 shares for each of the yearsthree month periods ended DecemberMarch 31, 2011, 20102013 and 2009,2012, respectively) would be to decrease the net loss per share.

Upon the completion of the 20112012 annual shareholders meeting on July 8, 2011May 22, 2012, where such actions wereaction was approved by shareholders, the Board of Directors authorized a reverse stock split of the Company’s common stock at a ratio of one-for-five,one-for-six, whereby each fivesix shares of common stock were combined into one share of common stock (the “Reverse Stock Split”). The Reverse Stock Split was implemented and effective with respect to shareholders of record at the close of business on July 28, 2011, and trading of the Company’s common stock on the NASDAQ Capital Market began on a split-adjusted basis beginning on July 29, 2011. As a result of the Reverse Stock Split, the total number of shares of common stock outstanding was reduced from approximately 40.1 million shares to approximately 8.0 million shares.

June 20, 2012. All historical references to shares and share amounts in this report have been retroactively revised to reflect the Reverse Stock Split, the principal effects of which were to:

1.reduce the number of shares of common stock issued and outstanding by a factor of 5;6;
2.increase the per share exercise price of options and warrants by a factor of 5,6, and decrease the number of shares issuable upon exercise by a factor of 5,6, for all outstanding options and warrants entitling the holders to purchase shares of the Company’s common stock; and
3.proportionately reduce the number of shares authorized and reserved for issuance under the Company’s existing equity compensation plans.

A reconciliation of historical basic and diluted weighted average number of shares outstanding retroactively adjusted for the Reverse Stock Split follows:

  
 December 31, 2010 December 31, 2009
Basic and diluted weighted average number of shares outstanding
          
Pre-split  39,247,604   33,169,172 
Post split  7,876,081   6,634,490 

Recently issued and adopted accounting pronouncements:

In April 2010, the FASB issued ASU 2010-17, “Revenue Recognition — Milestone Method (Topic 605): Milestone Method of Revenue Recognition.” The pronouncement provides guidance on the milestone method of revenue recognition for research and development arrangements. Under the milestone method contingent consideration received from the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved. A milestone is defined as an event (i) that can only be achieved based in whole or in part on either the entity’s performance or on the occurrence of a specific outcome resulting from the entity’s performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved, and (iii) that would result in additional payments being due to the entity. A milestone is substantive if the consideration earned from the achievement of the milestone is consistent with the performance required to achieve the milestone or the increase in value to the collaboration resulting from performance, relates solely to past performance, and is reasonable relative to all of the other deliverables and payments within the arrangement. The adoption of this ASU did not have a material impact on the Company’s financial statements.

Reclassifications:

Certain amounts in the accompanying financial statements for the yearsthree month period ended DecemberMarch 31, 20102012 was 9,633,321 shares on a pre-split basis and 2009 have been reclassified to conform to the presentation used in 2011.1,608,146 shares on a post-split basis.


F-11


 

TABLE OF CONTENTS

AspenBio Pharma,Venaxis, Inc.
 
Notes to Condensed Financial Statements
(Unaudited)

Note 2. Property and equipment:

Property and equipment consisted of the following as of December 31,:following:

    
 2011 2010 March 31,
2013
(Unaudited)
 December 31,
2012
Land and improvements $1,107,508  $1,107,508  $1,107,508  $1,107,508 
Building  2,589,231   2,589,231   2,589,231   2,589,231 
Building improvements  251,049   235,946   252,197   251,049 
Laboratory equipment  1,175,047   1,207,241   1,212,668   1,211,418 
Office and computer equipment  398,295   378,431   412,138   403,692 
  5,521,130   5,518,357   5,573,742   5,562,898 
Less accumulated depreciation  2,725,981   2,411,223   3,144,953   3,078,359 
 $2,795,149  $3,107,134  $2,428,789  $2,484,539 

Depreciation expense totaled approximately $402,000, $395,000$67,000 and $341,000$94,000 for each of yearsthe three month periods ended DecemberMarch 31, 2011, 20102013 and 2009,2012, respectively.

Note 3. Other long-term assets:

Other long-term assets consisted of the following as of December 31,:following:

    
 2011 2010 March 31,
2013
(Unaudited)
 December 31,
2012
Patents, trademarks and applications, net of accumulated amortization of $273,550 and $190,829 $1,214,748  $1,342,737 
Patents, trademarks and applications, net of accumulated amortization of $364,479 and $345,692 $1,221,195  $1,210,698 
Goodwill  387,239   387,239   387,239   387,239 
Other  9,665   15,374   2,530   3,957 
 $1,611,652  $1,745,350  $1,610,964  $1,601,894 

The Company capitalizes legal costs and filing fees associated with obtaining patents on its new discoveries. Once the patents have been issued, the Company amortizes these costs over the shorter of the legal life of the patent or its estimated economic life using the straight-line method. Based upon the current status of the above intangible assets, the aggregate amortization expense is estimated to be approximately $69,000$75,000 for each of the next five fiscal years. The Company tests intangible assets with finite lives upon significant changes in the Company’s business environment. The testing resulted in no patent impairment charges during the three months ended March 31, 2013 and approximately $42,000 of patent impairment charges during the three months ended March 31, 2012.

Note 4. Notes and other obligations:Other Obligations:

Notes payable and installmentother obligations consisted of the following as of December 31,:following:

    
 2011 2010 March 31,
2013
(Unaudited)
 December 31,
2012
Mortgage notes $2,545,312  $2,653,737  $2,402,823  $2,435,073 
Termination obligation (Note 9)  1,152,753    
Termination obligation  200,509   397,588 
Other short-term installment obligations  206,161   166,806   88,827   220,763 
  3,904,226   2,820,543   2,692,159   3,053,424 
Less current portion  1,074,185   273,861   1,945,383   2,290,292 
 $2,830,041  $2,546,682  $746,776  $763,132 

TABLE OF CONTENTS

Venaxis, Inc.

Notes to Condensed Financial Statements
(Unaudited)

Note 4. Notes and Other Obligations:  – (continued)

Mortgage notes:

The Company has a mortgage facility on its land and building. The mortgage is held by a commercial bank and includes approximately 35% that is guaranteed by the U.S.U. S. Small Business Administration (SBA). The loan is collateralized by the real property and is also personally guaranteed by a former officer of the Company. The interest rate on the bank portion is one percentage over the Wall Street Journal Prime Rate (minimum 7%), with 7% being the approximate effective rate for 20112013 and 2010,2012, and the SBA portion bears interest at the rate of 5.86%. The commercial bank portion of the loan requires total monthly payments of

F-12


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Financial Statements

Note 4. Notes and other obligations: - (continued)

approximately $14,200, which currently includes approximately $9,200$8,600 per month in contractual interest, through JuneJuly 2013 when the then remaining principal balance is due which is estimated to be approximately $1,607,000 at that time.$1.6 million. The SBA portion of the loan requires total monthly payments of approximately $9,200 through July 2023, which currently includes approximately $4,200$4,100 per month in contractual interest and fees.

Subsequent to March 31, 2013, the Company received a commitment from its current lender to refinance the commercial bank portion of the mortgage. Based on the letter of commitment received the Company’s expectation is that the new loan will close as proposed prior to July 2013. The proposed terms include an amortization period of fifteen years, with a balloon maturity at five years and the interest rate fixed at 3.95%. The expected monthly payments will be approximately $11,700, including $5,200 in contractual interest.

Other short-term installment obligations:Termination obligation:

In November 2011, the Company entered into a Termination Agreement with Novartis Animal Health, Inc. (the “Novartis Termination Agreement”) to terminate the Novartis License Agreement (Note 7). Under the Novartis Termination Agreement, the termination obligation originally totaled $1,374,000, which was payable $150,000 upon signing the Novartis Termination Agreement and in six equal subsequent quarterly installments of $204,000 each. The Company has executed financing agreementsdiscounted this obligation for certainfinancial reporting purposes to $1,303,000, using an assumed interest rate of 7% (which represents the Company’s insurance premiums.rate management believes it could have borrowed at for similar financings). At DecemberMarch 31, 2011, these obligations2013, the remaining outstanding termination obligation totaled $206,000 all ofapproximately $201,000 which areis due in 2012.June, 2013.

Future maturities:

The Company’s total debt obligations including the termination obligation, require minimum annual principal payments of approximately $1,074,000 in 2012, $2,067,000 in$1,929,000 for the remainder of 2013, $65,000 in 2014, $68,000 in 2015, $72,000$71,000 in 2016 and $558,000$559,000 thereafter, through the terms of the applicable debt agreements. The Company’s Exclusive License Agreement with The Washington University also requires minimum annual royalty payments of $20,000 per year during its term.

Note 5. Stockholders’ equity:

2011 Transactions:

In July 2011 at the annual shareholders meeting the Board of Directors approved an amendment to the Company’s Articles of Incorporation to reduce the authorized common shares from 60 million to 30 million.

In December 2011, the Company completed a registered direct offering of securities consisting of 1,605,000 units for a negotiated price of $1.02 per unit, generating approximately $1,456,000 in net proceeds to the Company. Fees and other expenses totaled $181,000, including a placement fee of 6.79%. Each unit consisted of one share of the Company’s no par value common stock and one warrant to purchase one share of common stock. The exercise price of each warrant is $1.22 per share; the warrants are exercisable beginning June 30, 2012 and expire in June 2017. The purpose of the offering was to raise funds for working capital, new product development and general corporate purposes.

2010 Transactions:

In May 2010, the Company completed a registered direct offering of securities consisting of 481,928 units (Units) for a negotiated price of $20.75 per Unit, generating approximately $9,117,000 in net proceeds to the Company. Fees and other expenses totaled $883,000, including a placement fee of 6.5%. Each Unit consisted of one share of the Company’s no par value common stock and one warrant to purchase 0.285 shares of common stock. Accordingly, a total of 481,928 shares of common stock and warrants to purchase 137,349 shares of common stock were issued. The exercise price of the warrants was $24.10 per share; the warrants were exercisable upon issuance for an eight month term and expired in January 2011. The purpose of the offering was to raise funds for working capital, new product development and general corporate purposes.

During the yearthree months ended DecemberMarch 31, 2010, consultants exercised options outstanding under the Company’s 2002 Stock Incentive Plan (the Plan) as amended2013 and approved by the Company’s shareholders, to purchase 52,209 shares of common stock generating $291,028 in cash proceeds to the Company.

2009 Transactions:

During the year ended December 31, 2009, former employees, prior to the termination of their option rights, exercised options outstanding under the Plan to purchase 121,000 shares of common stock generating $438,700 in cash proceeds to the Company, and consultants exercised options to purchase 7,600 shares of common stock generating $29,940 in cash proceeds. A consultant’s options to purchase 10,000 shares of common stock expired upon the consultant’s termination from the Company during 2009. During the year

F-13


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Financial Statements

Note 5. Stockholders’ equity: - (continued)

ended December 31, 2009, the holders of 134,185 warrants that2012, respectively, there were issued for investor relations services elected to exercise those warrants on a cashless basis as provided in the agreements and as a result, were issued 98,767 common shares.

In October 2009, the Company completed a placement of registered securities consisting of 1,031,000 common shares generating $8,260,000 in net proceeds to the Company. Fees and costs totaled $503,735, including a placement agent fee of 5% for certain investors. The purpose of the offering was to raise funds for working capital, new product development and general corporate purposes.no equity issuances.

Note 6. Stock options and warrants:

Stock options:

The Company currently provides stock-based compensation to employees, directors and consultants, both under the Company’s 2002 Stock Incentive Plan, as amended (the “Plan”), and non-qualified options and warrants issued outside of the Plan. The Company estimates the fair value of the share-based awards on the date of grant using the Black-Scholes option-pricing model (the “Black-Scholes model”). Using the Black-Scholes model, the value of the award that is ultimately expected to vest is recognized over the requisite service period in the statement of operations. Option forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company attributes compensation to expense using the straight-line single option method for all options granted.


TABLE OF CONTENTS

Venaxis, Inc.

Notes to Condensed Financial Statements
(Unaudited)

Note 6. Stock options and warrants:  – (continued)

The Company’s determination of the estimated fair value of share-based payment awards on the date of grant is affected by the following variables and assumptions:

The grant date exercise price  the closing market price of the Company’s common stock on the date of the grant;
Estimated option term  based on historical experience with existing option holders;
Estimated dividend rates  based on historical and anticipated dividends over the life of the option;
Term of the option  based on historical experience, grants have lives of approximately 3 – 5 years;
Risk-free interest rates  with maturities that approximate the expected life of the options granted;
Calculated stock price volatility  calculated over the expected life of the options granted, which is calculated based on the daily closing price of the Company’s common stock over a period equal to the expected term of the option; and
Option exercise behaviors  based on actual and projected employee stock option exercises and forfeitures.

The Company recognized total expenses for stock-based compensation during the yearsthree-month periods ended DecemberMarch 31, as follows:

     
 2011 2010 2009 2013 2012
Stock options to employees and directors $1,200,118  $2,103,276  $1,570,552  $483,625  $197,402 
Stock options to consultants for:
                         
Investor relations activities     20,227 
APPY1 activities  597   1,491 
Animal health activities  24,446   161,357   35,017      2,876 
AppyScore activities  54,304   38,064    
General and other activities        20,196 
Investor relations activities  57,309   61,174   89,171 
Total stock-based compensation $1,336,177  $2,363,871  $1,714,936  $484,222  $221,996 

F-14


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Financial Statements

Note 6. Stock options and warrants: - (continued)

The above expenses are included in the accompanying Statements of Operations for the yearsperiods ended DecemberMarch 31, in the following categories:

  
    Three Months Ended
 2011 2010 2009 2013 2012
Selling, general and administrative expenses $1,281,873  $2,325,807  $1,714,936  $483,625  $220,505 
Research and development expenses  54,304   38,064      597   1,491 
Total stock-based compensation $1,336,177  $2,363,871  $1,714,936  $484,222  $221,996 

During the three months ended March 31, 2013 and 2012, respectively, no options were exercised.


TABLE OF CONTENTS

Venaxis, Inc.

Notes to Condensed Financial Statements
(Unaudited)

Note 6. Stock options and warrants:  – (continued)

Stock incentive plan options:

The Company currently provides stock-based compensation to employees, directors and consultants under the Company’s 2002 Stock Incentive Plan, as amended (Plan). In July 2011, the Company’s shareholders approved an amendment to the Plan to increase the number of shares reserved under the Plan from 1,360,000 to 1,500,000.

The Company utilized assumptions in the estimation of fair value of stock-based compensation for the years ended December 31, as follows:

   
 2011 2010 2009
Dividend yield  0  0  0
Expected price volatility  119 to 120  110 to 119  113 to 119
Risk free interest rate  1.32 to 2.14  1.60 to 2.62  1.47 to 2.66
Expected term  5 years   5 years   5 years 

A summary of stock option activity under the Company’s Plan for options to employees, officers, directors and consultants, for the year ended December 31, 2011, is presented below:

    
 Shares Underlying Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate
Intrinsic
Value
Outstanding at January 1, 2011  1,103,358  $10.60           
Granted  313,600   3.19           
Exercised                
Forfeited ��(125,473  8.75       
Outstanding at December 31, 2011  1,291,485  $8.99   6.8  $  — 
Exercisable at December 31, 2011  757,664  $11.14   5.4  $ 

The aggregate intrinsic value in the table above represents the total intrinsic value (the difference between the Company’s closing stock price on December 31, 2011 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders, had all option holders been able to, and in fact had, exercised their options on December 31, 2011.

During the year ended December 31, 2011, 313,600 stock options were granted under the Plan to employees, officers, directors, and consultants with a weighted average fair value at the grant date of $3.19 per option. Included in the 313,600 options issued, existing directors and officers were granted a total of 245,000 options at an exercise price of $3.17 per share and existing employees were granted 25,900 options at an exercise price of $3.05 per share, all vesting over a three-year period annually in arrears and expiring in ten years. Four newly hired employees were granted a total of 2,700 options at $3.31 per share, all vesting over a three-year period annually in arrears and expiring in ten years. The Company also issued 40,000 non-qualified options to a consultant at an exercise price of $3.40 per share which expire in ten years. These non-qualified options are performance related with vesting tied to achieving specific AppyScore clinical and regulatory

F-15


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Financial Statements

Note 6. Stock options and warrants: - (continued)

milestones. During the year ended December 31, 2010, 279,600 stock options were granted under the Plan to employees, officers, directors and consultants with a weighted average fair value at the grant date of $8.55 per option. During the year ended December 31, 2009, there were 412,100 options granted under the Plan to employees, officers, directors and consultants with a weighted average fair value at the grant date of $8.25 per option.

During the year ended December 31, 2011, no options were exercised. During the year ended December 31, 2010, consultants exercised 52,209 options outstanding under the Company’s Plan generating $291,028 in cash and which had an intrinsic value when exercised of $371,130. During the year ended December 31, 2009, 128,600 options were exercised by employees, a former officer, and consultants at an average of $3.65 per that had an intrinsic value totaling $1,285,000.

During the year ended December 31, 2011, a total of 125,473 options granted under the Plan were forfeited, 68,413 of which were vested and 57,060 which were unvested. The options were exercisable at an average of $8.75 per share and were forfeited upon the employees’, officers and consultant’s termination from the Company. During the year ended December 31, 2010, a total of 9,140 options were forfeited, 2,667 of which were vested and 6,473 were unvested. The options were exercisable at an average of $13.25 per share and were forfeited upon the employees’ terminations from the Company. During the year ended December 31, 2009, a total of 70,720 options were forfeited, 26,667 of which were vested and 44,053 were unvested. The options were exercisable at an average of $13.40 per share and were forfeited upon the employees’, officer and advisor terminations from the Company.

The total fair value of stock options granted to employees, directors and consultants that vested and became exercisable during the years ended December 31, 2011, 2010 and 2009, was $2,063,000, $2,327,000 and $964,000, respectively. Based upon the Company’s experience, approximately 85% of the outstanding stock options, or approximately 1,098,000 options, are expected to vest in the future, under their terms.

A summary of the activity of non-vested options under the Company’s Plan to acquire common shares granted to employees, officers, directors and consultants during the year ended December 31, 2011 is presented below:

   
Nonvested Shares Nonvested Shares Underlying Options Weighted Average Exercise Price Weighted Average
Grant Date Fair Value
Nonvested at January 1, 2011  506,063  $10.80  $8.33 
Granted  313,600   3.19   2.64 
Vested  (228,782  12.31   9.02 
Forfeited  (57,060  8.63   7.04 
Nonvested at December 31, 2011  533,821  $5.94  $4.83 

At December 31, 2011, based upon employee, officer, director and consultant options granted to that point, there was approximately $1,096,000 additional unrecognized compensation cost related to stock options that will be recorded over a weighted average future period of approximately two years.

Subsequent to December 31, 2011, 121,533 options related to employee terminations expired which were exercisable at an average of $7.40 per share.

Other common stock purchase options and warrants:

As of December 31, 2011, in addition to the stock incentive plan options discussed above, the Company had outstanding 1,693,000 non-qualified options and warrants in connection with offering warrants, an officer’s employment and investor relations consulting.

F-16


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Financial Statements

Note 6. Stock options and warrants: - (continued)

The Company utilized assumptions in the estimation of the fair value of stock-based compensation for the years ended December 31, as follows:

201120102009
Dividend yield000
Expected price volatility119 to 145128 to 13071 to 128
Risk free interest rate1.20 to 1.951.26 to 1.701.14 to 1.62
Expected term3 to 10 years3 years3 years

Operating expenses for the years ended December 31, 2011, 2010 and 2009, include $92,000, $61,000 and $89,000, respectively, for the value of the non-qualified options and warrants.

Following is a summary of such outstanding options for the year ended December 31, 2011:

    
 Shares Underlying Options / Warrants Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic
Value
Outstanding at January 1, 2011  182,855  $25.15           
Granted  1,675,000   1.34           
Forfeited  (164,855  26.56       
Outstanding at December 31, 2011  1,693,000  $1.45   5.5  $  — 
Exercisable at December 31, 2011  40,500  $8.18   1.6  $ 

The aggregate intrinsic value in the table above represents the total intrinsic value (the difference between the Company’s closing stock price on December 31, 2011 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders, had all option holders been able to, and in fact had, exercised their options on December 31, 2011.

During the year ended December 31, 2011, the Company hired a Vice President of Marketing and Business who previously had a consulting relationship with the Company. As part of the employment arrangement, the Board approved an employment-inducement grant made outside of the Company’s Stock 2002 Incentive Plan, and he was granted 40,000 options for services exercisable at $3.25 per share. The options vest equally over a three year period on the first, second and third anniversary of the grant date and expire in ten years. Also, during the year ended December 31, 2011, an investor relations firm was granted 30,000 warrants to purchase shares of common stock which are scheduled to vest at 2,500 shares per month over the twelve months from the date of grant and are exercisable at $5.00 per share and expire in three years.

In December 2011, the Company closed a $1.6 million registered direct offering consisting of 1,605,000 shares of the Company’s no par value common stock and 1,605,000 warrants. The warrants which are included in the table above are not exercisable until June 30, 2012 at an exercise price of $1.22 per common share, and expire in June 2017. During the year ended December 31, 2011, 27,506 investor relations consultant options were forfeited of which 9,000 were exercisable at $60.00 per share, 7,506 options were exercisable at $30.05 per share, 10,000 options were exercisable at $27.85 per share, and 1,000 at $24.95 per share. In addition 137,349 warrants granted at $24.10 per share in connection with the 2010 public registered direct offering expired.

During the year ended December 31, 2010, 143,349 stock options and warrants were granted under to an investor relations firm and under a registered direct offering with a weighted average fair value at the grant date of $23.50 per option. During the year ended December 31, 2009, there were 12,000 options granted to an investor relations firm with a weighted average fair value at the grant date of $13.30 per option.

F-17


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Financial Statements

Note 6. Stock options and warrants: - (continued)

During the years ended December 31, 2011 and 2010, no options were exercised. During the year ended December 31, 2009, 134,185 options and warrants were exercised at an average of $8.45 per share that had an intrinsic value totaling $3,141,000.

The total fair value of stock options granted to an investor relations consulting firm that vested and became exercisable during the years ended December 31, 2011, 2010 and 2009, was $61,000, $61,000 and $89,000, respectively.

A summary of the activity of nonvested, non-qualified options and warrants in connection with employment and investor relations consulting services during the year ended December 31, 2011, is presented below:

   
Nonvested Shares Nonvested Shares Underlying Options Weighted Average Exercise Price Weighted Average
Grant Date Fair Value
Nonvested at January 1, 2011    $  $ 
Granted  70,000   4.00   2.69 
Vested  (22,500  5.00   2.70 
Forfeited         
Nonvested at December 31, 2011  47,500  $3.53  $2.69 

At December 31, 2011, there was approximately $97,000 in unrecognized cost for non-qualified options and warrants that will be recorded over a weighted average future period of approximately one year.

Subsequent to December 31, 2011, 3,000 investor relations options which were exercisable at $24.95 per share expired.

Note 7. Other income:

In 2010, the Company received $244,479 from the U.S. Department of Treasury under the qualifying therapeutic discovery project under Section 48D of the Internal Revenue Code which is included in other income for the year ended December 31, 2010.

Note 8. Income taxes:

Income taxes at the federal statutory rate are reconciled to the Company’s actual income taxes as follows:

   
 2011 2010 2009
Federal income tax benefit at 34% $(3,473,000 $(4,535,000 $(5,276,000
State income tax net of federal tax effect  (306,000  (400,000  (479,000
Permanent items  504,000   881,000   (258,000
Valuation allowance  3,275,000   4,054,000   6,013,000 
   $  $  $ 

As of December 31, 2011, the Company has net operating loss carry forwards of approximately $62 million for federal and state tax purposes, which are available to offset future taxable income, if any, expiring through December 2031. A valuation allowance was recorded at December 31, 2011 due to the uncertainty of realization of deferred tax assets in the future.

F-18


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Financial Statements

Note 8. Income taxes: - (continued)

The tax effects of temporary differences that give rise to significant portions of deferred tax assets and liabilities at December 31, 2011 and 2010, are as follows:

  
 2011 2010
Deferred tax assets (liabilities):
          
Net operating loss and credit carry forwards $22,767,000  $19,164,000 
Inventories  4,000   318,000 
Property and equipment  8,000   4,000 
Patents and other intangible assets  23,000   55,000 
Other  11,000   12,000 
Deferred revenue     340,000 
Research and development credit  692,000   650,000 
Deferred tax asset  23,505,000   20,543,000 
Valuation allowance  (23,505,000  (20,543,000
   $  $ 

Note 9. Commitments and contingencies:

Commitments:

Effective May 1, 2004 Washington University in St. Louis (WU) and AspenBio entered into The Exclusive License Agreement (WU License Agreement) which grants AspenBio exclusive license and right to sublicense WU’s technology (as defined under the WU License Agreement) for veterinary products worldwide, except where such products are prohibited under U.S. laws for export. The term of the WU License Agreement continues until the expiration of the last of WU’s patents (as defined in the WU License Agreement) to expire. AspenBio has agreed to pay minimum annual royalties of $20,000 annually during the term of the WU License Agreement and such amounts are creditable against future royalties. Royalties payable to WU under the WU License Agreement for covered product sales by AspenBio carry a mid-single digit royalty rate and for sublicense fees received by AspenBio carry a low double-digit royalty rate. The WU License Agreement contains customary terms for confidentiality, prosecution and infringement provisions for licensed patents, publication rights, indemnification and insurance coverage. The WU License Agreement is cancelable by AspenBio with ninety days advance notice at any time and by WU with sixty days advance notice if AspenBio materially breaches the WU License Agreement and fails to cure such breach.

The animal health technology, licensed from WU in 2004 and further developed at AspenBio, focuses on reproduction drugs, initially in the bovine, to be followed by other livestock species of economic importance. The bovine drugs were sub-licensed in 2008 to Novartis Animal Health (“NAH” or “Novartis”) under a long-term world-wide development and marketing agreement. Between 2008 and 2011, substantial investment and progress in product, regulatory and clinical activities were made on the bovine drug products.

Under the 2008, exclusive license and commercialization agreement (the “NAH License Agreement”) with Novartis the Company received an upfront cash payment of $2,000,000, of which 50% was non-refundable upon signing the agreement, and the balance of which was subject to certain conditions and milestones. In 2010, the conditions associated with $100,000 of such milestones were satisfied. As of the November 15, 2011 execution of the termination agreement, discussed below, the $900,000 remaining milestone payment was unachieved.

Revenue recognition related to the NAH License Agreement and WU Agreement was based primarily on the Company’s consideration of Accounting Standards Codification No. 808-10-45 (EITF 07-1), “Accounting for Collaborative Arrangements”, paragraphs 16 – 20. For financial reporting purposes, the up-front license fees received from the NAH License Agreement, net of the amounts due to WU, were recorded as deferred revenue and were being amortized over the term of the NAH License Agreement. The non-refundable net

F-19


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Financial Statements

Note 9. Commitments and contingencies: - (continued)

amount of $810,000 was being amortized as deferred revenue income to amortized license fee revenue over the 152 month original license period. Milestone contingent revenue was recognized into income commencing with the date such milestones were achieved. During the year ended December 31, 2010, milestones totaling $100,000 were achieved, triggering the commencement of amortization of $100,000 of deferred revenue over the then remaining license period. During the years ended December 31, 2011, 2010 and 2009, $62,179, $68,394 and $63,947, respectively, was recorded as the amortized license fee revenue arising from the NAH License Agreement. Cumulatively, from inception through November 15, 2011, the date of the termination Agreement, $242,481 had been recorded as the amortized license fee revenue arising from the NAH License Agreement. As of December 31, 2010 deferred revenue totaled $1,379,698 and net shared development costs totaled $760,147, payable to NAH under the Novartis License Agreement. As of the date of termination, future amortization of the deferred revenue was terminated.

A pilot study was completed during late 2010 using the bovine LH drug and subsequently NAH informed us that preliminary pilot study results revealed that the pilot study did not demonstrate the outcomes as defined in the success criteria, and NAH had requested a refund of the contingent $900,000 milestone payment that was tied to the pilot study outcome and notified us that they wished to terminate the agreements. On November 15, 2011, AspenBio and Novartis executed a Termination and Settlement Agreement (“Termination Agreement”) that provided for the termination of the existing agreements between the Company and NAH. Under the terms of the Termination Agreement, the Company will pay to NAH the refundable $900,000 milestone payment and a negotiated amount totaling $475,000 of the Company’s portion of net shared development expenses. The settlement amount is payable in quarterly installments commencing upon execution of the Termination Agreement. Upon execution of the Termination Agreement, the Company gained access to and use of all development and research materials and protocols developed under the prior NAH agreements. All of NAH’s rights under the prior agreements will be terminated in full once the Company pays the settlement amount in full.

As a result of the Termination Agreement with Novartis, the Company agreed to pay $150,000 upon signing the agreement and six equal quarterly installments thereafter, of $204,000 each. The Company discounted this future payment stream at an assumed interest rate of 7% (which represents the rate management believes it could have obtained for similar financings) resulting in a net liability at termination of $1,303,000. This obligation requires principal payments of approximately $755,000 in 2012 with the remaining balance of $398,000 due in 2013.

Upon execution of the Termination Agreement with Novartis, the Company recorded a gain of $938,896, arising from the elimination of both the $900,000 in remaining deferred revenue and the net accounts payable to Novartis the total of which exceeded the net recorded settlement obligation to Novartis. Net cash expenses of approximately $7,500 were incurred by the Company on the transaction.

Other commitments:

As of December 31, 2011, the Company has employment agreements with three officers providing aggregate annual minimum commitments totaling $650,000. The agreements automatically renew at the end of each year unless terminated by either party and contain customary confidentiality and benefit provisions.

Contingencies:

On September 1, 2010, the Company received a complaint, captioned Mark Chipman v. AspenBio Pharma, Inc., Case No. 2:10-cv-06537-GW-JC. The complaint was filed in the U.S. District Court in the Central District of California by an individual investor. The complaint includes allegations of fraud, negligent misrepresentation, violations of Section 10(b) of the Securities Exchange Act of 1934 (“Exchange Act”) and Securities and Exchange Commission (“SEC”) Rule 10b-5, and violations of Sections 25400 and 25500 of the California Corporations Code, all related to the Company’s blood-based acute appendicitis test in development known as AppyScore. On the Company’s motion, the action was transferred to the U.S. District

F-20


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Financial Statements

Note 9. Commitments and contingencies: - (continued)

Court for the District of Colorado by order dated January 21, 2011. The action has been assigned a District of Colorado Civil Case No. 11-cv-00163-REB-KMT. On September 7, 2011, the plaintiff filed an amended complaint. Based on a review of the amended complaint, the Company believes that the plaintiff’s allegations are without merit, and intends to vigorously defend against these claims. On October 7, 2011, the Company filed a motion to dismiss the amended complaint, and the plaintiff’s response and the Company’s reply thereto were subsequently filed. The motion is pending, awaiting a decision by the court.

On October 1, 2010, the Company received a complaint, captioned John Wolfe, individually and on behalf of all others similarly situated v. AspenBio Pharma, Inc. et al., Case No. CV10 7365. This federal securities purported class action was filed in the U.S. District Court in the Central District of California on behalf of all persons, other than the defendants, who purchased common stock of the Company during the period between February 22, 2007 and July 19, 2010, inclusive. The complaint names as defendants certain officers and directors of the Company during such period. The complaint includes allegations of violations of Section 10(b) of the Exchange Act and SEC Rule 10b-5 against all defendants, and of Section 20(a) of the Exchange Act against the individual defendants, all related to the Company’s blood-based acute appendicitis test in development known as AppyScore. On the Company’s motion, this action was also transferred to the U.S. District Court for the District of Colorado by order dated January 21, 2011. The action has been assigned a District of Colorado Civil Case No. 11-cv-00165-REB-KMT. On July 11, 2011, the court appointed a lead plaintiff and approved lead counsel. On August 23, 2011, the lead plaintiff filed an amended putative class action complaint, alleging the same class period. Based on a review of the amended complaint, the Company and the individual defendants believe that the plaintiffs’ allegations are without merit and intend to vigorously defend against these claims. On October 7, 2011, the Company filed a motion to dismiss the amended complaint, and the plaintiff’s response and the Company’s reply thereto were subsequently filed. The motion is pending, awaiting a decision by the court.

On January 4, 2011, a plaintiff filed a complaint in the U.S. District Court for the District of Colorado captioned Frank Trpisovsky v. Pusey, et al., Civil Action No. 11-cv-00023-PAB-BNB, that purports to be a shareholder derivative action on behalf of the Company against thirteen individual current or former officers and directors. The complaint also names the Company as a nominal defendant. The plaintiff asserts violations of Section 14(a) of the Exchange Act, SEC Rule 14a-9, breach of fiduciary duty, waste of corporate assets, and unjust enrichment. On motion of the Company and the individual defendants, the U.S. District Court has stayed this derivative action by order dated March 15, 2011, and this action continues to be stayed. The Company believes that the plaintiff lacks standing to proceed with this action and intends to challenge the plaintiff’s standing if and when the stay is lifted.

In the ordinary course of business and in the general industry in which the Company is engaged, it is not atypical to periodically receive a third party communication which may be in the form of a notice, threat, or ‘cease and desist’ letter concerning certain activities. For example, this can occur in the context of the Company’s pursuit of intellectual property rights. This can also occur in the context of operations such as the using, making, having made, selling, and offering to sell products and services, and in other contexts. The Company intends to make a rational assessment of each situation on a case-by-case basis as such may arise. The Company periodically evaluates its options for trademark positions and considers a full spectrum of alternatives for trademark protection and product branding.

F-21


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Financial Statements

Note 10. Supplemental data: Selected quarterly financial information (unaudited)

    
 March 31, June 30, September 30, December 31,
Fiscal 2011 quarters ended:
                    
Total revenues $97,000  $55,000  $22,000  $45,000 
Gross margin $85,000  $52,000  $22,000  $44,000 
Net loss $(2,806,000 $(2,787,000 $(3,064,000 $(1,557,000
Loss per share – Basic and diluted $(0.35 $(.35 $(0.38 $(0.16
Market price of common stock
                    
High $4.25  $3.94  $3.75  $2.92 
Low $2.80  $3.10  $2.40  $.97 
Fiscal 2010 quarters ended:
                    
Total revenues $142,000  $59,000  $80,000  $89,000 
Gross margin (loss) $77,000  $25,000  $(70,000 $(20,000
Net loss $(3,871,000 $(3,422,000 $(3,052,000 $(2,993,000
Loss per share – Basic and diluted $(0.50 $(0.45 $(0.40 $(0.40
Market price of common stock
                    
High $11.85  $23.20  $5.60  $3.55 
Low $9.55  $4.75  $2.45  $1.60 

F-22


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Balance Sheets

  
 March 31,
2012
(Unaudited)
 December 31,
2011
ASSETS
          
Current assets:
          
Cash and cash equivalents $1,316,462  $2,968,104 
Short term investments (Note 1)  561,778   1,003,124 
Accounts receivable (Note 7)  6,988   35,016 
Prepaid expenses and other current assets  205,757   314,800 
Total current assets  2,090,985   4,321,044 
Property and equipment, net (Notes 2 and 4)  2,701,548   2,795,149 
Other long term assets, net (Note 3)  1,574,077   1,611,652 
Total assets $6,366,610  $8,727,845 
LIABILITIES AND STOCKHOLDERS’ EQUITY
          
Current liabilities:
          
Accounts payable $460,578  $581,713 
Accrued compensation  17,753   47,622 
Accrued expenses  209,753   368,406 
Notes and other obligations, current portion (Note 4)  966,011   1,074,185 
Total current liabilities  1,654,095   2,071,926 
Notes and other obligations, less current portion (Note 4)  2,602,912   2,830,041 
Total liabilities  4,257,007   4,901,967 
Commitments and contingencies (Note 7)
          
Stockholders’ equity (Notes 5, 6 and 8):
          
Common stock, no par value, 30,000,000 shares authorized;
9,633,321 shares issued and outstanding, each period
  69,068,792   68,846,796 
Accumulated deficit  (66,959,189  (65,020,918
Total stockholders’ equity  2,109,603   3,825,878 
Total liabilities and stockholders’ equity $6,366,610  $8,727,845 

See Accompanying Notes to Unaudited Condensed Financial Statements

F-23


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Statements of Operations
Three Months Ended March 31
(Unaudited)

  
 2012 2011
Sales (Note 7) $7,275  $97,316 
Cost of sales  184   12,827 
Gross profit  7,091   84,489 
Other revenue – fee     17,765 
Operating expenses:
          
Selling, general and administrative  1,204,675   1,603,473 
Research and development  676,618   1,271,995 
Total operating expenses  1,881,293   2,875,468 
Operating loss  (1,874,202  (2,773,214
Other expense, net (primarily interest)  (64,069  (32,620
Net loss $(1,938,271 $(2,805,834
Basic and diluted net loss per share (Note 1) $(.20 $(.35
Basic and diluted weighted average number of shares outstanding (Note 1)  9,633,321   8,028,321 

See Accompanying Notes to Unaudited Condensed Financial Statements

F-24


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Statements of Cash Flows
Three Months Ended March 31
(Unaudited)

  
 2012 2011
Cash flows from operating activities:
          
Net loss $(1,938,271 $(2,805,834
Adjustments to reconcile net loss to net cash used in operating activities:
          
Stock-based compensation for services  221,996   383,348 
Depreciation and amortization  112,325   134,103 
Amortization of license fee     (17,765
Impairment charges  41,950   16,361 
Decrease in:
          
Accounts receivable  28,028   5,137 
Prepaid expenses and other current assets  109,043   91,083 
Increase (decrease) in:
          
Accounts payable  (121,135  224,589 
Accrued expenses  (188,522  491,767 
Deferred revenue     (675,000
Net cash used in operating activities  (1,734,586  (2,152,211
Cash flows from investing activities:
          
Sales of short-term investments  441,346   1,692,259 
Purchases of property and equipment     (43,974
Purchases of patent and trademark application costs  (23,099  (109,903
Net cash provided by investing activities  418,247   1,538,382 
Cash flows from financing activities:
          
Repayment of notes payable and other obligations  (335,303  (153,437
Net cash used in financing activities  (335,303  (153,437
Net decrease in cash and cash equivalents  (1,651,642  (767,266
Cash and cash equivalents at beginning of period  2,968,104   8,908,080 
Cash and cash equivalents at end of period $1,316,462  $8,140,814 
Supplemental disclosure of cash flow information:
          
Cash paid during the period for interest $64,768  $44,686 

See Accompanying Notes to Unaudited Condensed Financial Statements

F-25


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Condensed Financial Statements
(Unaudited)

INTERIM FINANCIAL STATEMENTS

The accompanying financial statements of AspenBio Pharma, Inc. (the “Company,” “we,” ”AspenBio” or “AspenBio Pharma”) have been prepared in accordance with the instructions to quarterly reports on Form 10-Q. In the opinion of management, all adjustments (which include only normal recurring adjustments) necessary to present fairly the financial position, results of operations and changes in financial position at March 31, 2012 and for all periods presented have been made. Certain information and footnote data necessary for fair presentation of financial position and results of operations in conformity with accounting principles generally accepted in the United States of America have been condensed or omitted. It is therefore suggested that these financial statements be read in conjunction with the summary of significant accounting policies and notes to financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2011. The results of operations for the period ended March 31, 2012 are not necessarily an indication of operating results for the full year.

Going concern, management’s plans and basis of presentation:

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company has experienced recurring losses and negative cash flows from operations, and at March 31, 2012 had cash and liquid investments of $1,878,000, working capital of $437,000, total stockholders’ equity of $2,110,000 and an accumulated deficit of $66,959,000. To date, the Company has in large part relied on equity financing to fund its operations. The Company expects to continue to incur losses from operations for the near-term and these losses could be significant as product development, contract consulting and other product development related expenses are incurred. The Company believes that its current working capital position will not be sufficient to meet its estimated cash needs for the remainder of 2012. These factors raise substantial doubt about the Company’s ability to continue as a going concern. If the Company does not obtain additional capital, then the Company would potentially be required to reduce the scope of its research and development activities or cease operations. The Company is actively looking to obtain additional financing; however, there can be no assurance that the Company will be able to obtain sufficient additional financing on terms acceptable to the Company, if at all, or that such financing will not have a significantly dilutive effect on the Company’s existing shareholders. The Company is closely monitoring its cash balances, cash needs and expense levels. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that might result should the Company be unable to continue as a going concern.

The Company’s ability to continue as a going concern depends on the success of management’s plans to bridge such cash shortfalls in 2012, which includes the following:

aggressively pursuing additional capital raising activities in 2012;
continuing to advance development of the Company’s products, particularly AppyScore;
continuing to advance the strategic process to monetize the Company’s animal health business and related intellectual property;
continuing to explore prospective partnering or licensing opportunities with complementary opportunities and technologies; and
continuing to monitor and implement cost control initiatives to conserve cash.

F-26


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Condensed Financial Statements
(Unaudited)

Note 1. Significant accounting policies:

Cash, cash equivalents and investments:

The Company considers all highly liquid investments with an original maturity of three months or less at the date of acquisition to be cash equivalents. From time to time, the Company’s cash account balances exceed the balances as covered by the Federal Deposit Insurance System. The Company has never suffered a loss due to such excess balances.

The Company invests excess cash from time to time in highly-liquid debt and equity investments of highly-rated entities which are classified as trading securities. The purpose of the investments is to fund research and development, product development, United States Food and Drug Administration (the “FDA”) approval-related activities and general corporate purposes. Such amounts are recorded at market values using Level 1 inputs in determining fair value and are classified as current, as the Company does not intend to hold the investments beyond twelve months. Investment securities classified as trading are those securities that are bought and held principally for the purpose of selling them in the near term, with the objective of preserving principal and generating profits. These securities are reported at fair value with unrealized gains and losses reported as an element of other (expense) income in current period earnings. The Company’s Board of Directors has approved an investment policy covering the investment parameters to be followed with the primary goals being the safety of principal amounts and maintaining liquidity of the fund. The policy provides for minimum investment rating requirements as well as limitations on investment duration and concentrations. Based upon market conditions, the investment guidelines have been tightened to increase the minimum acceptable investment ratings required for investments and shorten the maximum investment term. As of March 31, 2012, 63% of the investment portfolio was in cash and cash equivalents, which is presented as such on the accompanying balance sheet, and the remaining funds were invested in short-term marketable securities with none individually representing more than 13% of the portfolio and none with maturities past June 30, 2012. To date, the Company’s cumulative realized market loss from the investments has not been in excess of $5,000. For the three months ended March 31, 2012, there was approximately $1,260 in unrealized income, no realized gain or loss, and $657 in management fees. For the three months ended March 31, 2011, there was approximately $374 in unrealized income, no realized gain or loss, and $3,604 in management fees.

Fair value of financial instruments:

The Company accounts for financial instruments under Financial Accounting Standards Board (FASB) Accounting Standards Codification Topic (ASC) 820 (formerly Statement of Financial Accounting Standard (SFAS) No. 157), Fair Value Measurements. This statement defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles, and expands disclosures about fair value measurements. To increase consistency and comparability in fair value measurements, ASC 820 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels as follows:

Level 1 — quoted prices (unadjusted) in active markets for identical assets or liabilities;

Level 2 — observable inputs other than Level 1, quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, and model-derived prices whose inputs are observable or whose significant value drivers are observable; and

Level 3 — assets and liabilities whose significant value drivers are unobservable.

Observable inputs are based on market data obtained from independent sources, while unobservable inputs are based on the Company’s market assumptions. Unobservable inputs require significant management judgment or estimation. In some cases, the inputs used to measure an asset or liability may fall into different levels of the fair value hierarchy. In those instances, the fair value measurement is required to be classified using the lowest level of input that is significant to the fair value measurement. Such determination requires significant

F-27


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Condensed Financial Statements
(Unaudited)

Note 1. Significant accounting policies: - (continued)

management judgment. There were no financial assets or liabilities measured at fair value, with the exception of cash, cash equivalents and short-term investments as of March 31, 2012 and December 31, 2011.

The carrying amounts of the Company’s financial instruments (other than cash, cash equivalents and short-term investments as discussed above) approximate fair value because of their variable interest rates and/or short maturities combined with the recent historical interest rate levels.

Recently issued and adopted accounting pronouncements:

The Company has evaluated all recently issued accounting pronouncements and believes such pronouncements do not have a material effect on the Company’s financial statements.

Reclassifications:

Certain amounts in the accompanying financial statements for the three months ended March 31, 2011 have been reclassified to conform to the presentation used in 2012.

Income (loss) per share:

ASC 260, Earnings Per Share, requires dual presentation of basic and diluted earnings per share (EPS) with a reconciliation of the numerator and denominator of the basic EPS computation to the numerator and denominator of the diluted EPS computation. Basic EPS excludes dilution. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity.

Basic earnings (loss) per share includes no dilution and is computed by dividing net earnings (loss) available to shareholders by the weighted average number of common shares outstanding for the period. Diluted earnings per share reflect the potential dilution of securities that could share in the Company’s earnings (loss). The effect of the inclusion of the dilutive shares would have resulted in a decrease in loss per share. Accordingly, the weighted average shares outstanding have not been adjusted for dilutive shares. Outstanding stock options and warrants are not considered in the calculation, as the impact of the potential common shares (totaling approximately 2,862,000 shares as of March 31, 2012 and 1,281,000 shares as of March 31, 2011) would be to decrease the net loss per share.

Upon the completion of the 2011 annual shareholders meeting on July 8, 2011 where such actions were approved, the Board of Directors authorized a reverse stock split of the Company’s common stock at a ratio of one-for-five, whereby each five shares of common stock were combined into one share of common stock (the “Reverse Stock Split”). The Reverse Stock Split was effective with respect to shareholders of record at the close of business on July 28, 2011, and trading of the Company’s common stock on the NASDAQ Capital Market began on a split-adjusted basis beginning on July 29, 2011. As a result of the Reverse Stock Split, the basic and diluted weighted average number of shares outstanding for the three months ended March 31, 2011 was reduced from approximately 40.1 million shares to approximately 8.0 million shares. All historical references to shares and share amounts in this report have been retroactively revised to reflect the Reverse Stock Split.

F-28


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Condensed Financial Statements
(Unaudited)

Note 2. Property and equipment:

Property and equipment consisted of the following:

  
 March 31,
2012
(Unaudited)
 December 31,
2011
Land and improvements $1,107,508  $1,107,508 
Building  2,589,231   2,589,231 
Building improvements  251,049   251,049 
Laboratory equipment  1,175,047   1,175,047 
Office and computer equipment  398,295   398,295 
    5,521,130   5,521,130 
Less accumulated depreciation  (2,819,582  (2,725,981
   $2,701,548  $2,795,149 

Depreciation expense totaled approximately $94,000 and $100,000 for the three month periods ended March 31, 2012 and 2011, respectively.

Note 3. Other long-term assets:

Other long-term assets consisted of the following:

  
 March 31,
2012
(Unaudited)
 December 31,
2011
Patents, trademarks and applications, net of accumulated amortization of $290,848 and $273,550 $1,178,599  $1,214,748 
Goodwill  387,239   387,239 
Other  8,239   9,665 
Other $1,574,077  $1,611,652 

The Company capitalizes legal costs and filing fees associated with obtaining patents on its new discoveries. Once the patents have been issued, the Company amortizes these costs over the shorter of the legal life of the patent or its estimated economic life using the straight-line method. Based upon the current status of the above intangible assets, the aggregate amortization expense is estimated to be approximately $69,000 for each of the next five fiscal years.

Note 4. Notes and Other Obligations:

Notes payable and installment obligations consisted of the following:

  
 March 31,
2012
(Unaudited)
 December 31,
2011
Mortgage notes $2,517,791  $2,545,312 
Termination obligation  968,821   1,152,753 
Other short-term installment obligations  82,311   206,161 
    3,568,923   3,904,226 
Less current portion  (966,011  (1,074,185
   $2,602,912  $2,830,041 

F-29


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Condensed Financial Statements
(Unaudited)

Note 4. Notes and Other Obligations: - (continued)

Mortgage notes:

The Company has a mortgage facility on its land and building. The mortgage is held by a commercial bank and includes approximately 35% that is guaranteed by the U. S. Small Business Administration (SBA). The loan is collateralized by the real property and is also personally guaranteed by a former officer of the Company. The interest rate on the bank portion is one percentage over the Wall Street Journal Prime Rate (minimum 7%), with 7% being the approximate effective rate for 2012 and 2011, and the SBA portion bears interest at the rate of 5.86%. The commercial bank portion of the loan requires total monthly payments of approximately $14,200, which includes approximately $9,700 per month in contractual interest, through June 2013 when the then remaining principal balance is due which is estimated to be approximately $1,578,000 at that time. The SBA portion of the loan requires total monthly payments of approximately $9,200 through July 2023, which includes approximately $4,300 per month in contractual interest and fees.

Termination obligation:

In November 2011, the Company entered into a Termination Agreement with Novartis Animal Health, Inc. Under the agreement, the termination obligation totaled $1,374,000, which was payable $150,000 upon signing the Termination Agreement and six equal subsequent quarterly installments of $204,000 each. The Company discounted these obligations at an assumed interest rate of 7% (which represents the rate management believes it could have borrowed at for similar financings). At March 31, 2012, the remaining outstanding termination obligation totaled $968,821. This obligation requires principal payments of approximately $571,000 in the remainder of 2012 and the balance of $398,000 due in 2013.

Other short-term installment obligations:

The Company has executed financing agreements for certain of the Company’s insurance premiums. At March 31, 2012, these obligations totaled $82,000, all of which are due in 2012.

Future maturities:

The Company’s total debt obligations require minimum annual principal payments of approximately $739,000 for the remainder of 2012, $2,067,000 in 2013, $65,000 in 2014, $68,000 in 2015, $71,000 in 2016 and $559,000 thereafter, through the terms of the agreements.

Note 5. Stockholders’ equity:

During the three months ended March 31, 2012 and 2011, there were no equity issuances.

Note 6. Stock options and warrants:

Stock options:

The Company currently provides stock-based compensation to employees, directors and consultants under the Company’s 2002 Stock Incentive Plan, as amended (the “Plan”) and non-qualified options and warrants issued outside of the Plan. The Company estimates the fair value of the share-based awards on the date of grant using the Black-Scholes option-pricing model (the “Black-Scholes model”). Using the Black-Scholes model, the value of the award that is ultimately expected to vest is recognized over the requisite service period in the statement of operations. Option forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company attributes compensation to expense using the straight-line single option method for all options granted.

The Company’s determination of the estimated fair value of share-based payment awards on the date of grant is affected by the following variables and assumptions:

The grant date exercise price – the closing market price of the Company’s common stock on the date of the grant;

F-30


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Condensed Financial Statements
(Unaudited)

Note 6. Stock options and warrants: - (continued)

Estimated option term – based on historical experience with existing option holders;
Estimated dividend rates – based on historical and anticipated dividends over the life of the option;
Term of the option – based on historical experience, grants have lives of approximately 3 – 5 years;
Risk-free interest rates – with maturities that approximate the expected life of the options granted;
Calculated stock price volatility – calculated over the expected life of the options granted, which is calculated based on the daily closing price of the Company’s common stock over a period equal to the expected term of the option; and
Option exercise behaviors – based on actual and projected employee stock option exercises and forfeitures.

During the three months ended March 31, 2012, no stock options were granted under the Plan. The Company utilized the following assumptions in the estimation of fair value of stock-based compensation for the three months ended March 31, 2011: dividend yield of 0%, expected price volatility of 119%, risk free interest rate of 2.10% – 2.14%, and a five year expected option term.2013 as follows:

The Company recognized stock-based compensation

2013
Dividend yield0
Expected price volatility127 - 128
Risk free interest rate0.72 - 0.76
Expected term5 years

Operating expenses for the three monthsmonth periods ended March 31, as follows:

  
 2012 2011
Stock options to employees and directors $197,402  $364,285 
Stock options to consultants for:
          
Animal health activities  2,876   7,190 
AppyScore activities  1,491   11,873 
Investor relations activities  20,227    
Total stock-based compensation $221,996  $383,348 

The above expenses are included in the accompanying Statements of Operations2013 and 2012, include $470,000 and $193,000, respectively, for the three months ended March 31, invalue of the following categories:

  
 2012 2011
Selling, general and administrative expenses $220,505  $371,475 
Research and development expenses  1,491   11,873 
Total stock-based compensation $221,996  $383,348 

Stock incentive plan options:

The Company currently provides stock-based compensation to employees, directors and consultantsstock options issued under the Company’s Plan. In July 2011, the Company’s shareholders approved an amendment to the Plan to increase the number of shares reserved under the Plan from 1,360,000 to 1,500,000.

F-31


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Condensed Financial Statements
(Unaudited)

Note 6. Stock options and warrants: - (continued)

A summary of stock option activity under the Company’s Plan for options to employees, officers, directors and consultants, for the three months ended March 31, 2012,2013, is presented below:

        
 Shares
Underlying
Options
 Weighted
Average
Exercise
Price
 Weighted Average Remaining Contractual Term
(Years)
 Aggregate
Intrinsic
Value
 Shares
Underlying
Options
 Weighted
Average
Exercise
Price
 Weighted
Average
Remaining
Contractual
Term (Years)
 Aggregate
Intrinsic
Value
Outstanding at January 1, 2012  1,291,485  $8.99             
Outstanding at January 1, 2013  707,940  $13.98           
Granted                  474,270   2.09           
Exercised                                
Forfeited  (119,721  4.60         (6,644  2.43       
Outstanding at March 31, 2012  1,171,764  $9.43   6.3  $ 
Exercisable at March 31, 2012  934,536  $10.51   5.7  $ 
Outstanding at March 31, 2013  1,175,566  $9.25   9.05  $85,200 
Exercisable at March 31, 2013  261,506  $33.15   6.72  $10,400 

The aggregate intrinsic value in the table above represents the total intrinsic value (the difference between the Company’s closing stock price on March 31, 20122013 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders, had all option holders been able to, and in fact had, exercised their options on March 31, 2012.2013.

During the three months ended March 31, 2012, no stock2013, 474,270 options were granted under the Plan to employees, officers, directors and consultants. During the three months ended March 31, 2011, 150,900 stock options were granted under the Plan to employees, officers and directorsconsultants with a weighted average fair valueexercise price at the grant date of $2.45$2.09 per option. Included in the 150,900474,270 options issued, existingthe non-employee directors and officers were granted a total of 125,000168,000 options at an average exercise price of $2.95$2.19 per share of which majority vest quarterly over a one-year period, officers were granted 292,000 options at an average exercise price of $2.04 per share vesting over a twenty-four month period and existing employees were granted 25,90014,270 options at an average exercise price of $3.05$2.04 per share all vestingwhich vest over a three-yeartwenty-four month period annually in arrears and expiring infollowing grant. All options granted under the Company’s 2002 Stock Incentive Plan expire ten years.years from the grant date.

During the three months ended March 31, 2012 and 2011, no2013, a total of 6,644 options that were granted under the Plan to employees were forfeited, of which all were unvested. The options were exercised.

exercisable at an average of $2.43 per share and were forfeited upon the employees’ terminations from the Company. During the three months ended March 31, 2012, a total of 119,721 options that were granted under the Plan to employees, including an officer, were forfeited, 4,667 of which were vested and 115,054 were unvested. The options were exercisable at an average of $4.60 per share and were forfeited upon the employees’ terminations from the Company. During the three months ended March 31, 2011, a total of 49,733


TABLE OF CONTENTS

Venaxis, Inc.

Notes to Condensed Financial Statements
(Unaudited)

Note 6. Stock options that were granted under the Plan to employees, including an officer, were forfeited, 3,533 of which were vested and 46,200 were unvested. The options were exercisable at an average of $8.70 per share and were forfeited upon the employees’ terminations from the Company.

warrants:  – (continued)

The total fair value of stock options granted to employees, directors and consultants that vested and became exercisable during the three months ended March 31, 2013 and 2012, was $532,000 and 2011, was $1,142,000, and $1,726,000, respectively. Based upon the Company’s experience, approximately 85% of the outstanding nonvested stock options, or approximately 996,000777,000 options, are expected to vest in the future, under their terms.

F-32


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Condensed Financial Statements
(Unaudited)

Note 6. Stock options and warrants: - (continued)

A summary of the activity of non-vestednonvested options under the Company’s Plan to acquire common shares granted to employees, officers, directors and consultants during the three months ended March 31, 20122013 is presented below:

      
Nonvested Shares Nonvested
Shares
Underlying
Options
 Weighted
Average
Exercise
Price
 Weighted
Average
Grant Date
Fair Value
 Nonvested
Shares
Underlying
Options
 Weighted
Average
Exercise
Price
 Weighted
Average
Grant Date
Fair Value
Nonvested at January 1, 2012  533,821  $5.94  $4.83 
Nonvested at January 1, 2013  508,435  $3.70  $3.07 
Granted           474,270   2.09   1.78 
Vested  (181,539  7.76   6.29   (62,001  10.55   8.58 
Forfeited  (115,054  4.55   3.73   (6,644  2.43   2.04 
Nonvested at March 31, 2012  237,228  $5.22  $4.24 
Nonvested at March 31, 2013  914,060  $2.41  $2.03 

At March 31, 2012,2013, based upon employee, officer, director and consultant options granted under the Plan to that point, there was approximately $702,000$1,150,000 of additional unrecognized compensation cost related to stock options that will be recorded over a weighted average future period of approximately two years.one year.

Subsequent to March 31, 2012, in connection with its regular annual grant policy,2013, a total of 75,00010,000 stock options were granted to the Company’s independent directorsa newly hired employee exercisable at the then fair market value of $0.71,$1.99, per share, vesting over a three year period annually in arrears. An additional 38,800Additionally, effective as of May 1, 2013, in connection with the appointment of a new non-employee director, 41,333 stock options were granted, to employees exercisable at the then fair market pricevalue of $0.71 which vest equally over the twelve monthly periods following grant. In addition 210,000 stock options were awarded as retention incentive options to management employees, including Named Executive Officers exercisable at $0.66$1.75 per share, and vesting as to 50% on six monthover a three-year period in arrears of the anniversarydate of the grant datefor 24,000 of the options and in three equal installments on May 1, July 1 and October 1, 2013, respectively, for the remaining 50% vesting monthly in one-sixth increments over the remaining seventh through twelfth month following grant date. All options were granted under the Company’s 2002 Stock Incentive Plan and expire ten years from the grant date.

Subsequent to March 31, 2012, as a result of consultant and employee terminations, 49,879 options expired which had been exercisable at an average of $10.55 per share.17,333 options.

Other common stock purchase options and warrants:

As of March 31, 2012,2013, in addition to the stock incentive plan options discussed above, the Company had outstanding 1,690,000598,006 non-qualified options and warrants in connection with offering warrants, an officer’sofficers’ employment and investor relations consulting that were not issued under the Plan. Included in this total are 1,605,000 warrants exercisable at $1.22 per common share, issued to investors in the December 2011 registered direct offering.

During the three monthsmonth periods ended March 31, 2013 and 2012, respectively, no stock options were granted outside of the Plan. The Company utilized the following assumptions in the estimation of fair value of stock-based compensation for the three months ended March 31, 2011: dividend yield of 0%, expected price volatility of 119%, risk free interest rate of 1.95%, and a five year expected option term.

Operating expenses for the three months ended March 31, 2013 and 2012, include approximately $14,000 and 2011, include $29,179 and $7,460,$29,000, respectively, for the value of the non-qualified options and warrants.


F-33


 

TABLE OF CONTENTS

AspenBio Pharma,Venaxis, Inc.
 
Notes to Condensed Financial Statements
(Unaudited)

Note 6. Stock options and warrants:  - (continued)

Following is a summary of such outstanding options and warrants that were not issued underoutside of the Plan for the three months ended March 31, 2012:2013:

        
 Shares
Underlying
Options/
Warrants
 Weighted
Average
Exercise
Price
 Weighted
Average
Remaining
Contractual
Term
(Years)
 Aggregate
Intrinsic
Value
 Shares
Underlying
Options/
Warrants
 Weighted
Average
Exercise
Price
 Weighted
Average
Remaining
Contractual
Term (Years)
 Aggregate
Intrinsic
Value
Outstanding at January 1, 2012  1,693,000  $1.45             
Outstanding at January 1, 2013  598,507  $5.01           
Granted                                
Exercised                                
Forfeited  (3,000  24.95         (501  54.00       
Outstanding at March 31, 2012  1,690,000  $1.41   5.2  $ 
Exercisable at March 31, 2012  58,333  $5.78   3.2  $ 
Outstanding at March 31, 2013  598,006  $4.97   4.37  $ 
Exercisable at March 31, 2013  289,673  $7.59   4.47  $ 

The aggregate intrinsic value in the table above represents the total intrinsic value (the difference between the Company’s closing stock price on March 31, 20122013 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders, had all option holders been able to, and in fact had, exercised their options on March 31, 2012.2013.

During the three months ended March 31,In June 2012, there were no options granted. During the three months ended March 31, 2011, the Company hiredcompleted a Vice President$12.2 million public offering of Marketingsecurities and Business who previously hadin connection with that offering, granted the underwriter warrants to purchase a consulting relationship withtotal of 305,000 shares of common stock. These warrants which are included in the Company. As partabove table are not exercisable until June 2013 at an exercise price of the employment arrangement, the Board approved an employment-inducement grant made outside of the Company’s Stock 2002 Incentive Plan, and he was granted 40,000 options for services exercisable at $3.25$2.50 per share. The options vest equally over a three year period on the first, second and third anniversary of the grant dateshare, and expire in ten years.

During the three months endedJune 2017. Included at March 31, 2012, 3,0002013 in the 598,006 total outstanding options previouslyand warrants are 572,505 non-compensatory rights granted to an investor relations firm exercisable at $24.95 per share expired. During the three months ended March 31, 2011, 9,000 investor relations consultant options which were exercisable at $60.00 per share and 137,349 warrants exercisable at $24.10 per share in connection with the 2010 public registered direct offering expired.

During the three months ended March 31, 2012offerings and 2011, no options or warrants were exercised.25,501 rights issued under compensatory arrangements.

The total fair value of stock options previously granted to an investor relations consulting firm and to the Company’s Vice President Marketing and Businesscertain officers that vested and became exercisable during the three months ended March 31, 2013 and 2012, was $14,178 and 2011, was $56,033, and $0, respectively.

A summary of the activity of nonvested, non-qualified options and warrants granted outside of the Plan in connection with employment and investor relations consulting services outside of the Plan during the three months ended March 31, 2012,2013, is presented below:

      
Nonvested Shares Nonvested
Shares
Underlying
Options
 Weighted
Average
Exercise
Price
 Weighted
Average
Grant Date
Fair Value
 Nonvested
Shares
Underlying
Options
 Weighted
Average
Exercise
Price
 Weighted
Average
Grant Date
Fair Value
Nonvested at January 1, 2012  47,500  $3.53  $2.69 
Nonvested at January 1, 2013  8,332  $3.42  $2.84 
Granted                  
Vested  (20,833  3.88   2.69   (5,000  3.42   2.84 
Forfeited                  
Nonvested at March 31, 2012  26,667  $3.25  $2.69 
Nonvested at March 31, 2013  3,332  $3.42  $2.84 

F-34


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Condensed Financial Statements
(Unaudited)

Note 6. Stock options and warrants: - (continued)

At March 31, 2012,2013, there was approximately $68,000$8,000 in unrecognized cost for non-qualified options that will be recorded over a weighted average future period of approximatelyless than one year.


SubsequentTABLE OF CONTENTS

Venaxis, Inc.

Notes to March 31, 2012, 2,000 investor relations options which were exercisable at $7.95 per share expired.

Condensed Financial Statements
(Unaudited)

Note 7. Concentrations, commitments and contingencies:

Customer concentration:

At March 31, 2012, three customers accounted for the total accounts receivable. At December 31, 2011, two customers accounted for 73% and 19% of total accounts receivable. For the three months ended March 31, 2012, four customers represented the total sales for the period. For the three months ended March 31, 2011, three customers represented more than 10% of the Company’s sales, accounting for approximately 32%, 21%, and 15%, respectively, of the sales for the period.

Commitments:Animal Health License Agreements:

Effective May 1, 2004 Washington University in St. Louis (WU) and AspenBioVenaxis entered into Thean Exclusive License Agreement (WU License Agreement) which grants AspenBioVenaxis exclusive license and right to sublicense WU’s technology (as defined under the WU License Agreement) for veterinary products worldwide, except where such products are prohibited under U.S. laws for export. The term of the WU License Agreement continues until the expiration of the last of WU’s patents (as defined in the WU License Agreement) to expire. AspenBio. Venaxis has agreed to pay minimum annual royalties of $20,000 annually during the term of the WU License Agreement and such amounts are creditable against future royalties. Royalties payable to WU under the WU License Agreement for covered product sales by AspenBioVenaxis carry a mid-single digit royalty rate and for sublicense fees received by AspenBioVenaxis carry a low double-digit royalty rate. The WU License Agreement contains customary terms for confidentiality, prosecution and infringement provisions for licensed patents, publication rights, indemnification and insurance coverage. The WU License Agreement is cancelable by AspenBioVenaxis with ninety days advance notice at any time and by WU with sixty days advance notice if AspenBioVenaxis materially breaches the WU License Agreement and fails to cure such breach.

In July 2012, the Company entered into an Exclusive License Agreement (the “License Agreement”) with a licensee (“Licensee”), under which the Company granted the Licensee an exclusive royalty-bearing license to the Company’s intellectual property and other assets, including patent rights and know-how, relating to recombinant single chain reproductive hormone technology for use in non-human mammals (the “Company’s Animal Health Assets”). The License Agreement includes a sublicense of the technology licensed to the Company by WU. Under the terms of the WU License Agreement, a portion of license fees and royalties Venaxis receives from sublicensing agreements will be paid to WU. The obligation for such license fees due to WU is included in accrued expenses at March 31, 2013.

Under the License Agreement, the Licensee obtained a worldwide exclusive license to develop, seek regulatory approval for and offer to sell, market, distribute, import and export luteinizing hormone (“LH”) and/or follicle-stimulating hormone (“FSH”) products for bovine (cattle), equine and swine in the field of the assistance and facilitation of reproduction in bovine, equine and swine animals. The Company also granted the Licensee an option and right of first refusal to develop additional animal health products outside of the licensed field of use or any diagnostic pregnancy detection tests for non-human mammals.

Under the License Agreement as of March 31, 2013, the following future license fees and milestone payments are provided, assuming future milestones are successfully achieved:

License fees of $204,000 payable in June 2013;
Milestone payments, totaling up to a potential of $1.1 million in the aggregate, based on the satisfactory conclusion of milestones as defined in the License Agreement;
Potential for milestone payments of up to an additional $2 million for development and receipt of regulatory approval for additional licensed products; and
Royalties, at low double digit rates, based on sales of licensed products.

Revenue recognition related to the License Agreement and WU License Agreement is based primarily on the Company’s consideration of ASC 808-10-45, “Accounting for Collaborative Arrangements”. For financial reporting purposes, the license fees and milestone payments received from the License Agreement, net of the amounts due to third parties, including WU, have been recorded as deferred revenue and are amortized over the term of the License Agreement. License fees and milestone revenue totaling a net of approximately $1,182,000 commenced being amortized into income upon the July 2012 date of milestone achievement. As of March 31, 2013, deferred revenue of $84,995 has been classified as a current liability and $1,254,719 has been classified as a long-term liability. The current liability includes the next twelve months’ portion of the amortizable milestone revenue. During the three months ended March 31, 2013, $18,655 was recorded as the amortized license fee revenue arising from the License Agreement.


TABLE OF CONTENTS

Venaxis, Inc.

Notes to Condensed Financial Statements
(Unaudited)

Note 7. Animal Health License Agreements:  – (continued)

A tabular summary of the revenue categories and amounts of revenue recognition associated with the License Agreement follows:

 
Category Totals
License fees and milestone amounts received/achieved $1,716,000 
Third party obligations recorded, including WU  (337,060
Deferred revenue balance  1,378,940 
Revenue amortization to March 31, 2013  (39,226
Net deferred revenue balance at March 31, 2013 $1,339,714 

Commencement of license fees revenue recognitionUpon signing or receipt
Commencement of milestone revenue recognitionUpon milestone achievement over then remaining life
Original amortization period197 months

The animal health technology licensed from WU in 2004 was sub-licensed in 2008 to Novartis Animal Health (“Novartis”) under a long-term world-wide development and marketing agreement. In November 2011, the Company entered into a Termination Agreement with Novartis Animal Health, Inc. (the “Novartis Termination Agreement”) to terminate the Novartis License Agreement. Under the Novartis Termination Agreement, the original termination obligation totaled $1,374,000, which was payable $150,000 upon signing the Novartis Termination Agreement and six equal subsequent quarterly installments of $204,000 each. At March 31, 2013, the remaining outstanding termination obligation totaled $200,509 which is due in 2013. Between 2008 and 2011, the Company received up-front license fees which were recorded, net of the amounts due to WU, in accordance with ASC 808. Prior to the Novartis Termination Agreement the non-refundable net amount of $810,000 was being amortized to license fee revenue over the 152 month original license period. Upon execution of the Termination Agreement with Novartis, the Company recorded a gain of $938,896, arising from the elimination of both the $900,000 in remaining deferred revenue and the net accounts payable to Novartis the total of which exceeded the net settlement obligation to Novartis. As of the date of termination, future amortization of the deferred revenue was terminated.

Note 8. Commitments and contingencies:

Employment commitments:

As of March 31, 2012,2013, the Company has employment agreements with three officers providing aggregate annual minimum commitments totaling $650,000.$780,000. The agreements automatically renew at the end of each year unless terminated by either party and contain customary confidentiality and benefit provisions.

Contingencies:

On September 1, 2010, the Company received a complaint, captioned Mark Chipman v. AspenBio Pharma, Inc., Case No. 2:10-cv-06537-GW-JC. The complaint was filed in the U.S. District Court in the Central District of California by an individual investor. The complaint includes allegations of fraud, negligent misrepresentation, violations of Section 10(b) of the Exchange Act and SEC Rule 10b-5, and violations of Sections 25400 and 25500 of the California Corporations Code, all related to the Company’s blood-based acute appendicitis test in development known as AppyScore. On the Company’s motion, the action was transferred to the U.S. District Court for the District of Colorado by order dated January 21, 2011. The action has been assigned a District of Colorado Civil Case No. 11-cv-00163-REB-KMT. On September 7, 2011, the plaintiff filed an amended complaint. Based on a review of the amended complaint, the Company believes that the plaintiff’s allegations are without merit, and intends to vigorously defend against these claims. On October 7, 2011, the Company filed a motion to dismiss the amended complaint, and the plaintiff’s response and the Company’s reply thereto were subsequently filed. Currently, the motion is pending, awaiting a decision by the court.

F-35


TABLE OF CONTENTS

AspenBio Pharma, Inc.

Notes to Condensed Financial Statements
(Unaudited)

Note 7. Concentrations, commitments and contingencies: - (continued)

On October 1, 2010, the Company received a complaint, captioned John Wolfe, individually and on behalf of all others similarly situated v. AspenBio Pharma, Inc. (now Venaxis, Inc.) et al., Case No. CV10 7365.7365 (“Wolfe Suit”). This federal securities purported class action was filed in the U.S. District Court in the Central District of California on behalf of all persons, other than the defendants, who purchased common stock of the Company during the period between February 22, 2007 and July 19, 2010, inclusive. The complaint namesnamed as defendants certain officers and directors of the Company during such period. The complaint includesincluded allegations of violations of Section 10(b) of the Exchange Act and SEC Rule 10b-5 against all defendants, and of Section 20(a) of the Exchange Act against the individual defendants, all related to the Company’s blood-based acute appendicitis test in development known as AppyScore.development. On the Company’s motion, this action was also transferred to the U.S. District Court for the District of Colorado by order dated January 21, 2011. The action has beenwas assigned a District of Colorado Civil Case No. 11-cv-00165-REB-KMT. On July 11, 2011, the court appointed a lead plaintiff and approved lead counsel. On August 23, 2011, the lead plaintiff filed an amended putative class action complaint, allegingcomplaint.


TABLE OF CONTENTS

Venaxis, Inc.

Notes to Condensed Financial Statements
(Unaudited)

Note 8. Commitments and contingencies:  – (continued)

On October 7, 2011, the same class period. BasedCompany filed a motion to dismiss the amended complaint. On September 13, 2012, the United States District Court for Colorado granted the Company’s motion to dismiss, dismissing the plaintiffs’ claims against all defendants without prejudice. On September 14, 2012, the court entered Final Judgment without prejudice on a reviewbehalf of all defendants and against all plaintiffs in the Wolfe Suit. The Order to dismiss the action found in favor of the amended complaint,company and all of the individual defendants. On October 12, 2012, the plaintiffs filed a Notice of Appeal of the Order granting the motion to dismiss and of the Final Judgment in the Wolfe Suit. The plaintiffs filed their opening brief with the Tenth Circuit Court of Appeals on March 1, 2013. The Company filed its answering brief with the Tenth Circuit Court of Appeals on April 8, 2013. The Company and the individual defendants believe that the plaintiffs’ allegations are without merit, have vigorously defended against these claims, and intend to vigorously defend against these claims. On October 7, 2011, the Company filed a motioncontinue to dismiss the amended complaint, and the plaintiff’s response and the Company’s reply thereto were subsequently filed. Currently, the motion is pending, awaiting a decision by the court.do so.

On January 4, 2011, a plaintiff filed a complaint in the U.S. District Court for the District of Colorado captioned Frank Trpisovskyv.Trpisovsky v. Pusey, et al, Civil Action No. 11-cv-00023-PAB-BNB, that purports to be a shareholder derivative action on behalf of the Company against thirteen individual current or former officers and directors. The complaint also names the Company as a nominal defendant. The plaintiff asserts violations of Section 14(a) of the Exchange Act, SEC Rule 14a-9, breach of fiduciary duty, waste of corporate assets, and unjust enrichment. On motion of the Company and the individual defendants, the U.S. District Court has stayed this derivative action by order dated March 15, 2011,2011. On October 18, 2012, the parties filed a Joint Status Report, reporting on updates in the Wolfe Suit and stating that the stay should remain in place at this time and that a further status report should be submitted after the appeal in the Wolfe Suit has been resolved. On October 25, 2012, the magistrate judge issued a recommendation that the case be administratively closed, subject to reopening for good cause. The U.S. District Court on November 14, 2012, accepted the recommendation and ordered this action continuesadministratively closed, subject to be stayed. The Company believes that the plaintiff lacks standing to proceed with this action and intends to challenge the plaintiff’s standing if and when the stay is lifted.reopening for good cause.

In the ordinary course of business and in the general industry in which the Company is engaged, it is not atypical to periodically receive a third party communication which may be in the form of a notice, threat, or ‘cease and desist’ letter concerning certain activities. For example, this can occur in the context of the Company’s pursuit of intellectual property rights. This can also occur in the context of operations such as the using, making, having made, selling, and offering to sell products and services, and in other contexts. The Company makes rational assessment of each situation on a case-by-case basis as such may arise. The Company periodically evaluates its options for trademark positions and considers a full spectrum of alternatives for trademark protection and product branding.

Note 8. Subsequent event:

UnderWe are not a party to any other legal proceedings, the termsadverse outcome of an agreement for investor relations services, the Company issued 25,000 shareswhich would, in our management's opinion, have a material adverse effect on our business, financial condition and results of Common Stock on April 2, 2012, at $0.71 per share.operations.


F-36


 

TABLE OF CONTENTS

[GRAPHIC MISSING]


TABLE OF CONTENTS

 

 

 

     Shares
 
 
 
$15,000,000 of Shares
Common Stock

VENAXIS, INC.
 
 
 

Common Stock

[GRAPHIC MISSING]

 
 
 
 
 
 
 
 



PROSPECTUS








 
 
 

Aegis Capital Corp
PROSPECTUS


 
 
 
 
 
 
 
 


Piper Jaffray



, 20122013

 


 
 

TABLE OF CONTENTS

Part II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 13. Other Expenses of Issuance and Distribution

The following table lists the costs and expenses payable by the Company in connection with the sale of the common stock covered by this prospectus other than any sales commissions or discounts. All amounts shown are estimates except for the SEC registration fee, NASDAQ listing fee and FINRA fee and all of the fees and expenses will be borne by the Company.

  
SEC registration fee $2,084  $3,137 
NASDAQ listing fees  65,000   65,000 
FINRA fee  2,319   3,950 
Legal fees and expenses  225,000   300,000 
Accounting fees and expenses  30,000   20,000 
Printing, transfer agent and miscellaneous expenses  125,597   102,913 
Total $450,000  $495,000 

Item 14. Indemnification of Directors and Officers

Our Articles of Incorporation and Bylaws require us to indemnify our officers, directors, employees and agents against reasonably incurred expenses (including legal fees), judgments, penalties, fines and amounts incurred in the settlement of any action, suit or proceeding if it is determined that such person conducted himself in good faith and that he reasonably believed (i) in the case of conduct in his official capacity, that his conduct was in the Company’s best interest, (ii) in all other cases (except criminal proceedings) that his conduct was at least not opposed to the Company’s best interests, or (iii) in the case of any criminal proceeding, that he has not reasonable cause to believe that his conduct was unlawful.

This determination shall be made by a majority vote of directors at a meeting at which a quorum is present, provided however that the quorum can only consist of directors not parties to the proceeding. If a quorum cannot be obtained, the determination may be made by a majority vote of a committee of the board, consisting of two or more directors who are not parties to the proceeding. Directors who are parties to the proceeding may participate in the designation of members to serve on the committee. If a quorum of the board or a committee cannot be established, the determination may be made (i) by independent legal counsel selected by a vote of the board of directors or committee in the manner described in this paragraph or, if a quorum cannot be obtained or a committee cannot be established, by independent legal counsel selected by a majority of the full board (including directors who are parties to the proceeding) or (ii) by a vote of the shareholders. Any officer, director, employee or agent may seek court-ordered indemnification from the court conducting the proceeding. The court may then determine whether such person should be entitled to indemnification.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of us pursuant to the foregoing provisions, or otherwise, we have been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by us of expenses incurred or paid by a director, officer or controlling person of the Company in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, we will, unless in the opinion of our counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by the Company is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

Section 7-108-402 of the Colorado Business Corporation Act (the “Act”) provides, generally, that the articles of incorporation may contain a provision eliminating or limiting the personal liability of a director to the corporation or its shareholders for monetary damages for breach of fiduciary duty as a director, except that any such provision shall not eliminate or limit the liability of a director (i) for any breach of the director’s duty of loyalty to the corporation or its shareholders, (ii) acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, (iii) acts specified in Section 7-108-403 of the Act

II-1


 
 

TABLE OF CONTENTS

(unlawful distributions), or (iv) any transaction from which the director directly or indirectly derived an improper personal benefit. Such provision may not eliminate or limit the liability of a director for any act or omission occurring prior to the date on which such provision becomes effective. The Company’s articles of incorporation contain such a provision.

Section 7-109-103 of the Act provides, that a corporation organized under Colorado law shall be required to indemnify a person who is or was a director of the corporation or an individual who, while serving as a director of the corporation, is or was serving at the corporation’s request as a director, an officer, an agent, an associate, an employee, a fiduciary, a manager, a member, a partner, a promoter, or a trustee of, or to hold any similar position with, another domestic or foreign corporation or other person or of an employee benefit plan (a “Director”) of the corporation and who was wholly successful, on the merits or otherwise, in the defense of any threatened, pending, or completed action, suit, or proceeding, whether civil, criminal, administrative, or investigative and whether formal or informal (a “Proceeding”), in which he was a party, against reasonable expenses incurred by him in connection with the Proceeding, unless such indemnity is limited by the corporation’s articles of incorporation.

Section 7-109-102 of the Act provides, generally, that a corporation may indemnify a person made a party to a Proceeding because the person is or was a Director against any obligation incurred with respect to a Proceeding to pay a judgment, settlement, penalty, fine (including an excise tax assessed with respect to an employee benefit plan) or reasonable expenses incurred in the Proceeding if the person conducted himself or herself in good faith and the person reasonably believed, in the case of conduct in an official capacity with the corporation, the person’s conduct was in the corporation’s best interests and, in all other cases, his or her conduct was at least not opposed to the corporation’s best interests and, with respect to any criminal proceedings, the person had no reasonable cause to believe that his or her conduct was unlawful. A corporation may not indemnify a Director in connection with any Proceeding by or in the right of the corporation in which the Director was adjudged liable to the corporation or, in connection with any other Proceeding charging that the Director derived an improper personal benefit, whether or not involving actions in an official capacity, in which Proceeding the Director was judged liable on the basis that he or she derived an improper personal benefit. Any indemnification permitted in connection with a Proceeding by or in the right of the corporation is limited to reasonable expenses incurred in connection with such Proceeding.

Under Section 7-109-107 of the Act, unless otherwise provided in the articles of incorporation, a corporation may indemnify an officer, employee, fiduciary, or agent of the corporation to the same extent as a Director and may indemnify an officer, employee, fiduciary, or agent who is not a Director to a greater extent, if not inconsistent with public policy and if provided for by its bylaws, general or specific action of its board of directors or shareholders, or contract.

Item 15. Recent Sales of Unregistered Securities

On each of April 2, 2012 25,000and June 1, 2012, 4,167 shares (prior to the 1-for-6 reverse stock split expected to be effected immediately prior to the date of this prospectus) of restricted common stock were granted to a consultant in consideration for investor relations services. These shares of common stock vested upon grant.

As incentive compensation, the Company awarded Donald Hurd, Senior Vice President and Chief Commercial Officer, non-qualified stock options to acquire 120,000 shares of Company common stock exercisable at $0.57, the fair market value of the Company’s common stock on May 23, 2012, the “Grant Date”. The options grant, which is an employment-inducement grant made outside of the Company’s 2002 Stock Incentive Plan, as amended, has the following additional material terms: the stock options shall vest as to 50% of the total at the six-month anniversary of the Grant Date, and the balance shall vest one-twelfth monthly over months seven through twelve following the Grant Date. Any stock options granted that are then unvested, shall vest upon the consummation of a “Change in Control” of AspenBio, using the same definition as contained in the Company’s 2002 Stock Incentive Plan, as amended. The options are exercisable for a period of ten (10) years after the Grant Date, subject to earlier termination on cessation of service with the Company.

In June 2012, in connection with its public offering, the Company issued warrants to purchase 305,000 shares of common stock to Aegis Capital Corp., the underwriter in the public offering. The warrants were immediately exercisable, have an exercise price equal to $2.50 per share, and expire on June 19, 2017.

II-2


TABLE OF CONTENTS

During the year ended December 31, 2011, the Company hired a Vice President of Marketing and Business who previously had a consulting relationship with the Company. As part of the employment arrangement, the Board of Directors approved an employment-inducement grant made outside of the Company’s 2002 Stock Incentive Plan, and he was granted 6,667 options for services exercisable at $19.50 per share. The options vest equally over a three year period on the first, second and third anniversary of the grant date and expire in ten years.

During the year ended December 31, 2011, an investor relations firm was granted warrants to purchase 5,000 shares of common stock which vest at 416 shares per month over the twelve months from the date of grant, are exercisable at $30.00 per share and expire three years from the date of grant.

The Company relied on the exemption under section 4(2) of the Securities Act of 1933 (the “Act”) for the above issuanceissuances because we:the Company: (i) did not engage in any public advertising or general solicitation in connection with the warrant issuance; (ii) made available to the recipient disclosure regarding all aspects of our business including our reports filed with the SEC and our press releases, and other financial, business, and corporate information; and (iii) believed that the recipient obtained all information regarding the Company requested (or believed appropriate) and received answers to all questions posed by the recipient, and otherwise understood the risks of accepting our securities for investment purposes. No commission or other remuneration was paid on this issuance.

As incentive compensation, the Company has awarded Donald Hurd, Senior Vice President and Chief Commercial Officer, non-qualified stock options to acquire 120,000 shares of Company common stock exercisable at $0.57, the fair market value of the Company’s common stock on May 23, 2012, the “Grant Date”. The options grant, which is an employment-inducement grant made outside of the Company’s 2002 Stock Incentive Plan, as amended, has the following additional material terms: the stock options shall vest as to 50% of the total at the six-month anniversary of the Grant Date, and the balance shall vest one-twelfth

II-2


TABLE OF CONTENTS

monthly over months seven through twelve following the Grant Date. Any stock options granted that are then unvested, shall vest upon the consummation of a “Change in Control” of AspenBio, using the same definition as contained in the Company’s 2002 Stock Incentive Plan, as amended. The options are exercisable for a period of ten (10) years after the Grant Date, subject to earlier termination on cessation of service with the Company.these issuances.

Item 16. Exhibits and Financial Statement Schedules

The following exhibits are filed as part of, or incorporated by reference into this registration statement:

 
Exhibit
Number
 Identification Of Exhibit
1.1*   1.1 Form of Underwriting AgreementPurchase Agreement*
3.1 Articles of Incorporation filed July 24, 2000(1)
3.1.1 Articles of Amendment to the Articles of Incorporation filed December 26, 2001(1)
3.1.2 Articles of Amendment to the Articles of Incorporation filed November 9, 2005(2)
3.1.2 3.1.3 Articles of Amendment to the Articles of Incorporation filed July 29, 2011(17)(15)
 3.1.4Articles of Amendment to the Articles of Incorporation filed June 19, 2012(21)
 3.1.5Articles of Amendment to the Articles of Incorporation, as amended, of Venaxis, Inc., dated and filed December 12, 2012.(23)
3.2 Amended and Restated Bylaws(3)
4.1 Specimen Certificate of Common Stock(1)(22)
4.2Form of Warrant between the Company and certain investors signatory thereto.(10)
4.3 Form of Common Stock Warrant between AspenBioVenaxis and Liolios Group, Inc.(12)(26)
4.4   4.3 Form of Warrant between the Company and each of the investors signatories to the Securities Purchase Agreement dated December 23, 2011(18)(16)
   5.1*4.4Form of Warrant between the Company and the underwriter under each of an Underwriting Agreement dated June 19, 2012, November 14, 2012 and November 15, 2012, respectively(21)
   5.1 Opinion of Ballard Spahr LLPLLP*
10.1 2002 Stock Incentive Plan, as amended and restated effective July 1, 2007(13)(11)
10.1.1 Amendment to 2002 Stock Incentive Plan, dated June 9, 2008(12)(10)
10.1.2 Amendment to 2002 Stock Incentive Plan, dated November 20, 2009(12)(10)
10.1.3 Amendment to 2002 Stock Incentive Plan, dated November 22, 2010(14)(12)
10.1.4 Amendment to Amended and Restated 2002 Stock Incentive Plan, as amended, dated July 8, 2011(16)(14)
10.1.5 Amendment to Amended and Restated 2002 Stock Incentive Plan, as amended, datedof Venaxis, Inc., effective May 22, 20122012.(21)(19)
10.210.1.6 Placement Agent Agreement, dated April 30, 2010, between the CompanyAmendment to Amended and Lazard Capital Markets LLC.Restated 2002 Stock Incentive Plan, as amended, of Venaxis, Inc., effective December 11, 2012.(10)(23)
10.2.1  10.2 Form of SubscriptionUnderwriting Agreement between the Company and each of the investors signatories thereto.(10)(21)
10.3 Placement Agency Agreement, dated December 23, 2011, between the Company and Landenburg Thalmann & Co. Inc.(18)(16)

II-3


TABLE OF CONTENTS

Exhibit NumberIdentification Of Exhibit
10.3.1 Form of Securities Purchase Agreement between the Company and each of the investors signatories thereto.(18)(16)
10.4 Exclusive License Agreement, dated May 1, 2004 between AspenBioVenaxis and The Washington University, as amended.(11)(9)
10.5  10.5. Debt Modification Agreement dated June 13, 2003 with FirstBankexecuted May 9, 2013, and effective as of Tech Center.April 8, 2013 between Venaxis, Inc. and FirstBank.(4)(25)
10.5.1 Loan Agreement between AspenBio,Venaxis, Inc. and Front Range Regional Economic Development Corporation dated June 13, 2003 for $1,300,000 regarding loan for physical plant or capital equipment acquisitions.(4)
10.5.2 Promissory Note dated June 13, 2003 by AspenBio, Inc. to Front Range Regional Economic Development Corporation in principal amount of $1,300,000.(4)

II-3


TABLE OF CONTENTS

Exhibit
Number
Identification Of Exhibit
10.5.3Unconditional Guarantee dated June 13, 2003 by AspenBio,Venaxis, Inc. to Front Range Regional Economic Development Corporation in principal amount of $1,300,000.(4)
10.5.3Unconditional Guarantee dated June 13, 2003 by Venaxis, Inc. to Front Range Regional Economic Development Corporation in principal amount of $1,300,000.(4)
10.6 Exclusive License Agreement with Novartis Animal Health, Inc., dated as of April 2, 2008.(5)
10.6.1 Amendment to Exclusive License Agreement with Novartis Animal Health, Inc., dated July 26, 2010(15)(13)
10.6.2 Termination and Settlement Agreement with Novartis Animal Health, Inc., dated November 15, 2011(20)(17)
10.7 Executive Employment Agreement with Jeffrey McGonegal, effective as of February 10, 2009.(6)
10.8 Assignment and Consultation Agreement, dated May 29, 2003, between AspenBioVenaxis and John Bealer, M.D.(7)
10.9 Executive Employment Agreement with Greg Pusey effective as of January 1, 2010.(12)(10)
10.10 Executive Employment Agreement with Stephen Lundy effective as of March 24, 2010.(19)(8)
10.11 Form of Stock Option Agreement under the 2002 Stock Incentive Plan, as amended and restated and amended.(12)(10)
10.12 Non-Employee Director Compensation.(12)(24)
10.13 Executive Employment Agreement withbetween Venaxis, Inc. and Donald R. Hurd, effective as ofdated May 23, 2012.(22)(18)
23.1*   10.14Exclusive License Agreement, dated July 25, 2012, between Ceva Sante Animale S.A. and Venaxis, Inc.(20)
  23.1 Consent of GHP Horwath, P. C.P.C.*
23.2*  23.2 Consent of Ballard Spahr LLP (included(Included in Exhibit 5.1).*
24.1 Power of Attorney (included(26)
 101Interactive data files pursuant to Rule 405 of Regulation S-T: (i) the Balance Sheets, (ii) the Statements of Operations, (iii) Statements of Stockholders Equity, (iv) the Statement of Cash Flows and (v) the Notes to the Financial Statements (A)(24)
(A)Pursuant to Rule 106T for Regulation S-T, the XBRL related information in Exhibit 101 to the Annual Report on signature pageForm 10-K shall not be deemed to this registration statement).be filed by the Company for purposes of Section 18 or any other provision of the Exchange Act of 1934, as amended.

*Filed herewith.
(1)Incorporated by reference from the registrant’s Registration Statement on Form S-1 (File no. 333-86190), filed April 12, 2002.
(2)Incorporated by reference from the registrant’s Report on Form 10-QSB for the quarter ended October 31, 2005, filed November 10, 2005.
(3)Incorporated by reference from the registrant’s Report on Form 10-Q for the quarter ended March 31, 2008 filed on May 15, 2008.
(4)Incorporated by reference from the registrant’s Report on Form 10-KSB/A for the year ended December 31, 2004 (file no. 000-50019), filed March 29, 2004.
(5)Incorporated by reference from the registrant’s Report on Form 10-Q for the quarter ended June 30, 2008, filed August 13, 2008.

II-4


TABLE OF CONTENTS

(6)Incorporated by reference from the registrant’s Report on Form 8-K dated February 10, 2009, filed on February 17, 2009.
(7)Incorporated by reference from the registrant’s Report on Form 10-K for the year ended December 31, 2008, filed March 16, 2009.
(8)Incorporated by reference from the registrant’s Report on Form 8-K dated January 19, 2009,March 25, 2010, filed January 23, 2009.March 26, 2010.
(9)Incorporated by reference from the registrant’s Report on Form 10-KSB for the year ended December 31, 2007, filed March 21, 2008.
(10)Incorporated by reference from the registrant’s Report on Form 8-K dated and filed on April 30, 2010.
(11)Incorporated by reference from the registrant’s Report on Form 10-Q for the quarter ended June 30, 2010, filed August 5, 2010.
(12)(10)Incorporated by reference from the registrant’s Report on Form 10-K for the year ended December 31, 2009, filed March 9, 2010.
(13)(11)Incorporated by reference from the registrant’s Registration Statement on Form S-8, filed June 22, 2007.
(14)(12)Incorporated by reference from the registrant’s Report on Form 8-K, dated November 22, 2010 and filed November 29, 2010.

II-4


TABLE OF CONTENTS

(15)(13)Incorporated by reference from the registrant’s Report on Form 10-K for the year ended December 31, 2010, filed April 15, 2011.
(16)(14)Incorporated by reference from the registrant’s Report on Form 8-K, dated July 8, 2011 and filed July 13, 2011.
(17)(15)Incorporated by reference from the registrant’s Report on Form 8-K, dated and filed July 29, 2011.
(18)(16)Incorporated by reference from the registrant’s Report on Form 8-K, dated December 23, 2011 and filed December 28, 2011.
(19)Incorporated by reference from the registrant’s Report on Form 8-K dated as of March 24, 2010 and filed March 26, 2010.
(20)(17)Incorporated by reference from the registrant’s Report on Form 10-K/A for the year ended December 31, 2011, filed April 9, 2012.
(21)(18)Incorporated by reference from the registrant’s Report on Form 8-K, dated May 23, 2012 and filed May 24, 2012.
(19)Incorporated by reference from the registrant’s Report on Form 8-K, dated May 22, 2012 and filed May 24, 2012.
(20)Incorporated by reference from the registrant’s Report on Form 8-K, dated July 25, 2012 and filed July 30, 2012.
(21)Incorporated by reference from the registrant’s Report on Form 8-K, dated June 19, 2012 and filed June 20, 2012.
(22)Incorporated by reference from the registrant’s Report on Form 8-K, dated and filed June 25, 2012.
(23)Incorporated by reference from the registrant’s Report on Form 8-K, dated December 11, 2012 and filed December 13, 2012.
(24)Incorporated by reference from the registrant’s Report on Form 10-K for the year ended December 31, 2012, filed march 26, 2013.
(25)Incorporated by reference from the registrant’s Report on Form 8-K, dated May 23, 20129, 2013 and filed May 24, 2012.9, 2013.
(26)Incorporated by reference to the registrant’s Registration Statement on Form S-1, filed May 9, 2013.

Item 17. Undertakings

(h) Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers, and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer, or controlling person of the registrant in the successful defense of any action, suit, or proceeding) is asserted by such director, officer, or controlling person connected with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

(i)The undersigned registrant hereby undertakes that:
1.For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.
2.For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

II-5


 
 

TABLE OF CONTENTS

(i) The undersigned registrant hereby undertakes that:

1. For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b) (1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.

2. For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

II-6


TABLE OF CONTENTS

SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this registration statementAmendment No. 1 to Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized in Castle Rock, Douglas County, State of Colorado, on May 25, 2012.20, 2013.

Venaxis, Inc.

By:AspenBio Pharma, Inc.

By:

/s/ Stephen T. Lundy

Stephen T. Lundy
President and Chief Executive Officer
(principal executive officer)

By :

By:

/s/ Jeffrey G. McGonegal

Jeffrey G. McGonegal
Chief Financial Officer (principal
(principal financial officer and
principal accounting officer)

II-6


TABLE OF CONTENTS

SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, this registration statementAmendment No. 1 to Registration Statement has been signed below by the following persons in the capacities and on the dates indicated.

  
SignaturesSignature Title Date
/s/ Stephen T. Lundy

Stephen T. Lundy
 President, Chief Executive Officer and
Director (principal executive officer)
 May 25, 201220, 2013
/s/ Jeffrey G. McGonegal

Jeffrey G. McGonegal
 Chief Financial Officer (principal financial
officer and principal accounting officer)
 May 25, 201220, 2013
/s/ Jeffrey G. McGonegal, as attorney-in-fact*

Gail S. Schoettler
 Non-Executive Chair and May 20, 2013
*

Susan A. Evans
Director May 25, 201220, 2013
/s/ Jeffrey G. McGonegal, as attorney-in-fact*

Daryl J. Faulkner
 Director May 25, 201220, 2013
/s/ Jeffrey G. McGonegal, as attorney-in-fact*
Gregory Pusey
Vice President and DirectorMay 25, 2012
/s/ Jeffrey G. McGonegal, as attorney-in-fact
Douglas I. HeplerJohn H. Landon
 Director May 25, 201220, 2013
/s/ Jeffrey G. McGonegal, as attorney-in-fact*

David E. Welch
 Director May 25, 201220, 2013
/s/ Jeffrey G. McGonegal, as attorney-in-fact
Mark J. Ratain
Stephen A. Williams
 Director May   25, 2012, 2013

*By:

/s/ Jeffrey G. McGonegal as attorney-in-fact
Michael R. Merson

DirectorMay 25, 2012
/s/
Jeffrey G. McGonegal as attorney-in-fact
John H. Landon
DirectorMay 25, 2012Attorney-in-fact

II-7


TABLE OF CONTENTS

EXHIBIT INDEX

The following exhibits are filed as part of, or incorporated by reference into this registration statement:

Exhibit NumberIdentification Of Exhibit
1.1*Form of Underwriting Agreement
3.1Articles of Incorporation filed July 24, 2000(1)
3.1.1Articles of Amendment to the Articles of Incorporation filed December 26, 2001(1)
3.1.2Articles of Amendment to the Articles of Incorporation filed November 9, 2005(2)
3.1.2Articles of Amendment to the Articles of Incorporation filed July 29, 2011(17)
3.2Amended and Restated Bylaws(3)
4.1Specimen Certificate of Common Stock(1)
4.2Form of Warrant between the Company and certain investors signatory thereto.(10)
4.3Form of Common Stock Warrant between AspenBio and Liolios Group, Inc.(12)
4.4Form of Warrant between the Company and each of the investors signatories to the Securities Purchase Agreement dated December 23, 2011(18)
 5.1*Opinion of Ballard Spahr LLP
10.12002 Stock Incentive Plan, as amended and restated effective July 1, 2007(13)
10.1.1Amendment to 2002 Stock Incentive Plan, dated June 9, 2008(12)
10.1.2Amendment to 2002 Stock Incentive Plan, dated November 20, 2009(12)
10.1.3Amendment to 2002 Stock Incentive Plan, dated November 22, 2010(14)
10.1.4Amendment to Amended and Restated 2002 Stock Incentive Plan, as amended, dated July 8, 2011(16)
10.1.5Amendment to Amended and Restated 2002 Stock Incentive Plan, as amended, dated May 22, 2012(21)
10.2Placement Agent Agreement, dated April 30, 2010, between the Company and Lazard Capital Markets LLC.(10)
10.2.1Form of Subscription Agreement between the Company and each of the investors signatories thereto.(10)
10.3Placement Agency Agreement, dated December 23, 2011, between the Company and Landenburg Thalmann & Co. Inc.(18)
10.3.1Form of Securities Purchase Agreement between the Company and each of the investors signatories thereto.(18)
10.4Exclusive License Agreement, dated May 1, 2004 between AspenBio and The Washington University, as amended.(11)
10.5Debt Modification Agreement dated June 13, 2003 with FirstBank of Tech Center.(4)
10.5.1Loan Agreement between AspenBio, Inc. and Front Range Regional Economic Development Corporation dated June 13, 2003 for $1,300,000 regarding loan for physical plant or capital equipment acquisitions.(4)
10.5.2Promissory Note dated June 13, 2003 by AspenBio, Inc. to Front Range Regional Economic Development Corporation in principal amount of $1,300,000.(4)
10.5.3Unconditional Guarantee dated June 13, 2003 by AspenBio, Inc. to Front Range Regional Economic Development Corporation in principal amount of $1,300,000.(4)
10.6Exclusive License Agreement with Novartis Animal Health, Inc., dated as of April 2, 2008.(5)
10.6.1Amendment I to Exclusive License Agreement with Novartis Animal Health, dated July 26, 2010(15)

II-8


TABLE OF CONTENTS

Exhibit NumberIdentification Of Exhibit
10.6.2Termination and Settlement Agreement with Novartis Animal Health, dated November 15, 2011(20)
10.7Employment Agreement with Jeffrey McGonegal, effective as of February 10, 2009.(6)
10.8Assignment and Consultation Agreement, dated May 29, 2003, between AspenBio and John Bealer, M.D.(7)
10.9Employment Agreement with Greg Pusey effective as of January 1, 2010.(12)
10.10Employment Agreement with Stephen Lundy effective as of March 24, 2010.(19)
10.11Form of Stock Option Agreement under the 2002 Stock Incentive Plan, as amended and restated and amended.(12)
10.12Non-Employee Director Compensation.(12)
10.13Employment Agreement with Donald R. Hurd, effective as of May 23, 2012.(22)
23.1*Consent of GHP Horwath, P.C.
23.2*Consent of Ballard Spahr LLP (included in Exhibit 5.1).
24.1Power of Attorney (included on signature page to this registration statement).

*Filed herewith.
(1)Incorporated by reference from the registrant’s Registration Statement on Form S-1 (File no. 333-86190), filed April 12, 2002.
(2)Incorporated by reference from the registrant’s Report on Form 10-QSB for the quarter ended October 31, 2005, filed November 10, 2005.
(3)Incorporated by reference from the registrant’s Report on Form 10-Q for the quarter ended March 31, 2008 filed on May 15, 2008.
(4)Incorporated by reference from the registrant’s Report on Form 10-KSB/A for the year ended December 31, 2004 (file no. 000-50019), filed March 29, 2004.
(5)Incorporated by reference from the registrant’s Report on Form 10-Q for the quarter ended June 30, 2008, filed August 13, 2008.
(6)Incorporated by reference from the registrant’s Report on Form 8-K dated February 10, 2009, filed on February 17, 2009.
(7)Incorporated by reference from the registrant’s Report on Form 10-K for the year ended December 31, 2008, filed March 16, 2009.
(8)Incorporated by reference from the registrant’s Report on Form 8-K dated January 19, 2009, filed January 23, 2009.
(9)Incorporated by reference from the registrant’s Report on Form 10-KSB for the year ended December 31, 2007, filed March 21, 2008.
(10)Incorporated by reference from the registrant’s Report on Form 8-K dated and filed on April 30, 2010.
(11)Incorporated by reference from the registrant’s Report on Form 10-Q for the quarter ended June 30, 2010, filed August 5, 2010.
(12)Incorporated by reference from the registrant’s Report on Form 10-K for the year ended December 31, 2009, filed March 9, 2010.
(13)Incorporated by reference from the registrant’s Registration Statement on Form S-8, filed June 22, 2007.
(14)Incorporated by reference from the registrant’s Report on Form 8-K, dated November 22, 2010 and filed November 29, 2010.
(15)Incorporated by reference from the registrant’s Report on Form 10-K for the year ended December 31, 2010, filed April 15, 2011.
(16)Incorporated by reference from the registrant’s Report on Form 8-K, dated July 8, 2011 and filed July 13, 2011.
(17)Incorporated by reference from the registrant’s Report on Form 8-K, dated and filed July 29, 2011.

II-9


TABLE OF CONTENTS

(18)Incorporated by reference from the registrant’s Report on Form 8-K, dated December 23, 2011 and filed December 28, 2011.
(19)Incorporated by reference from the registrant’s Report on Form 8-K dated as of March 24, 2010 and filed March 26, 2010.
(20)Incorporated by reference from the registrant’s Report on Form 10-K/A for the year ended December 31, 2011, filed April 9, 2012.
(21)Incorporated by reference from the registrant’s Report on Form 8-K, dated May 22, 2012 and filed May 24, 2012.
(22)Incorporated by reference from the registrant’s Report on Form 8-K, dated May 23, 2012 and filed May 24, 2012.

II-10