As
Filedfiled with the Securities and Exchange Commission onMarch 24, 2004May 14, 2015Registration No.
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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.WASHINGTON, DC 20549
----------------------------------FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
---------------------------------- ACCESS PHARMACEUTICALS,PLASMATECH
BIOPHARMACEUTICALS, INC.(Exact(Exact name of registrant as specified in its charter)
---------------------------------- Delaware 3841 - ---------------------------- ---------------------------- (State or Other Jurisdiction (Primary Standard Industrial of Incorporation or Organization) Classification Code Number) 83-0221517 ----------------- (I.R.S. Employer Identification No.) ---------------------------------- 2600 Stemmons Freeway,
| Delaware | 83-0221517 | |
| (State or other jurisdiction of incorporation or organization) | (IRS Employer Identification Number) |
4848 Lemmon Avenue, Suite 176517, Dallas, Texas 75207 TX 75219
(214) 905-5100
(Address,
(Address, including zip code, and telephone number, including area code, of registrant'sregistrant’s principal executive offices)
----------------------------------
Kerry P. Gray
President and Chief Executive Officer
Access Pharmaceuticals, Inc.
2600 Stemmons Freeway, Suite 176
Dallas, Texas 75207
(214) 905-5100
(Name,
John J. Concannon III, Esq.
Morgan, Lewis & Bockius LLP
One Federal Street
Boston, Massachusetts 02110
(617) 951-8000
(Name, address, including zip code, and telephone number, including area code, of agent for service)
------------------------------------
with copies to:
John J. Concannon III
Bingham McCutchen LLP
150 Federal Street
Boston, MA 02110
(617) 951-8000
-----------------------------------
Approximate date of commencement of proposed sale to the public: As
soon as practicable
From time to time after the effective date of this Registration Statement is declared effective.
Statement.
If the only securities being registered on this formForm are being offered pursuant to dividend or interest reinvestment plans, please check the following box. / /
¨
If any of the securities being registered on this formForm are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check the following box. /X/
x
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. / /
¨
If this Form is a post-effective amendment filed pursuant to Rule 462(c) 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. / /
¨
If delivery ofthis Form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the prospectus is expected to be madeCommission pursuant to Rule 434,
please462(e) under the Securities Act, check the following box. / /
CALCULATION OF REGISTRATION FEE
Title¨
If this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of Securitiessecurities pursuant to be Amount to be Registered Proposed Maximum
Registered Offering Price Per
Share(1)
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Common Stock $.01 par 2,393,196 shares (2) $5.38
value per share
Proposed Maximum
Aggregate Offering Amount of
Price (1) Registration Fee
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$12,875,394 $1,631.31 (3)
(1) Estimated solely for the purpose of determining the registration fee.
Calculated in accordance with Rule 457(c)413(b) under the Securities Act, check the following box. ¨
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 the definitions of 1933 based on the average“large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the high and low prices as reportedSecurities Exchange Act of 1934.
| Large accelerated filer ¨ | Accelerated filer ¨ | Non-accelerated filer ¨ | Smaller reporting company x | |||
| (Do not check if a smaller reporting company) | ||||||
CALCULATION OF REGISTRATION FEE
| Title of each class of securities to be registered | Amount to be Registered(1) | Proposed maximum per share offering price(2) | Proposed maximum aggregate offering price(2) | Amount of registration fee | ||||||||||||
| Common Stock, par value $0.01 per share | 1,925,000 | $ | 7.31 | $ | 14,071,750 | $ | 1,635.14 | |||||||||
| (1) | This Registration Statement registers 1,925,000 shares of common stock of Plasmatech Biopharmaceuticals, Inc., of which 675,000 are issuable upon exercise of warrants. This Registration Statement also relates to such additional securities (i) to be offered or issued in connection with any provision of any securities purported to be registered hereby to be offered pursuant to terms which provide for a change in the amount of securities being offered or issued to prevent dilution resulting from stock splits, stock dividends, or similar transactions and (ii) of the same class as the securities covered by |
| (2) | Estimated solely for the purpose of calculating the registration fee in accordance with Rule 457(c) under the Securities Act. The price per share and aggregate offering price are based on the average of the high and low sales prices of the common stock on May 8, 2015, as reported on The NASDAQ Capital Market. |
We hereby amend this registration statement (the “Registration Statement”) on such date or dates as may be necessary to delay its effective date until the Registrantwe 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 or until thethis Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.
PROSPECTUS
Access Pharmaceuticals, Inc.
The information contained in this prospectus is not complete and may be changed. We may not sell these securities until the Registration Statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and we are not soliciting offers to buy these securities in any jurisdiction where such offer or sale is not permitted.
Subject to completion, March 24, 2004.
2,293,196Completion, Dated May 14, 2015
PROSPECTUS
PLASMATECH
BIOPHARMACEUTICALS, INC.
1,925,000 Shares of Common Stock $.01 par value per share
This prospectus relates to the salepossible resale, from time to time, by certainthe selling stockholders of ours, the
Selling Stockholders,identified in this prospectus of up to 2,393,1961,925,000 shares of our common stock, including 603,825par value $0.01 per share, initially issued in a private placement, of which 675,000 shares are issuable upon the exercise of warrants. If
The selling stockholders may offer the warrantsshares from time to time as each selling stockholder may determine through public or private transactions or through other means described in the section entitled “Plan of Distribution” or a supplement to this prospectus. Each selling stockholder may also sell shares under Rule 144 under the Securities Act of 1933, as amended, if available, rather than under this prospectus.
The registration of these shares does not necessarily mean that any holders will sell any of their shares or exercise their warrants. We are exercised, wenot offering for sale any shares of our common stock pursuant to this prospectus. We will not receive theany cash proceeds from such exercise
if paymentthe sale of any of our shares of common stock by the selling stockholders, but we have agreed to pay certain registration expenses.
Our common stock is made in cash.listed on The NASDAQ Capital Market under the symbol “PTBI.” On March 22, 2004,May 13, 2015, the last saleclosing price of our Common Stockcommon stock was $5.47$8.60 per share, as reported by the American Stock Exchange, or AMEX, under
the symbol AKC.
share.
The mailing address of our principal executive offices is 4848 Lemmon Avenue, Suite 517, Dallas, Texas 75219. Our telephone number is (214) 905-5100.
Investing in the common stockour securities involves certain risks. For a discussion of certain
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factorsBefore investing, you should consider, see "Risk Factors"refer to the risk factors beginning on Page 2.
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page 8 of this prospectus, included in our periodic reports, in prospectus supplements and in other information filed by us with the Securities and Exchange Commission.
This prospectus may not be used to offer or sell any securities unless accompanied by a prospectus supplement.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined
ifpassed upon the adequacy or accuracy of this prospectus is truthful or complete.prospectus. Any representation to the contrary is a criminal offense.
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The date of this prospectus is March __, 2004
Table, 2015.
TABLE OF CONTENTS
Prospectus
We have not authorized any dealer, agent or other person to give any information or to make any representation other than those contained or incorporated by reference in this prospectus. You must not rely upon any information or representation not contained or incorporated by reference in this prospectus. This prospectus does not constitute an offer to sell or the solicitation of Contents
Page
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Access Pharmaceuticals,an offer to buy any securities other than the registered securities to which they relate, nor do this prospectus and the accompanying prospectus supplement, if any, constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction. You should not assume that the information contained in this prospectus is accurate on any date subsequent to the date set forth on the front of the document or that any information we have incorporated by reference is correct on any date subsequent to the date of the document incorporated by reference, even though this prospectus is delivered or securities are sold on a later date.
References in this prospectus to the terms “the Company,” “PlasmaTech,” “we,” “our” and “us” or other similar terms mean PlasmaTech Biopharmaceuticals, Inc. 2
Risk Factors 2
Forward Looking Statements 11
Use of Proceeds 12
Selling Stockholders 12
Plan of Distribution 13
Legal Matters 15
Experts 15
Where You Can Get More Information 15
Certain Information , unless we state otherwise or the context indicates otherwise.
We Are Incorporating By Reference 16
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ACCESS PHARMACEUTICALS, INC.
General
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Access Pharmaceuticals isare an emerging pharmaceutical company. We arebiopharmaceutical company focused on developing both novel lowa range of pharmaceutical products primarily based upon our nanopolymer chemistry technologies, and salt diafiltration process (“SDF”) technology recently licensed from Plasma Technologies LLC (“Licensor”). We currently have one marketed product licensed in the U.S., Europe, China, Australia, New Zealand and Korea. We also have additional products and platform technologies in various stages of development risk product candidates
and technologies with longer-term major product opportunities.
are seeking partners to continue development and/or to license the technology.
We were foundedincorporated in Wyoming in 1974 as Chemex Corporation, and in 1983 we changed our name to Chemex Pharmaceuticals, Inc. We changed our state of incorporation from Wyoming to Delaware on June 30, 1989. In 1996 we merged with Access Pharmaceuticals, Inc., a private Texas corporation, and changed our name to Access Pharmaceuticals, Inc.On October 24, 2014 we changed our name from Access Pharmaceuticals, Inc. to PlasmaTech Biopharmaceuticals, Inc. Our principal executive office is located at 2600 Stemmons Freeway,4848 Lemmon Avenue, Suite 176,517, Dallas, Texas 75207; our75219. Our telephone number is (214) 905-5100. Products
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Milestone Payments And Royalties By Product
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The following table reflects aggregate milestone payments received to
December 31, 2003, aggregate possible milestone payments under
agreements signed as of December 31, 2003 and royalties received to
December 31, 2003.
Milestones Royalties
Received to Aggregate Possible Received to
Product 12/31/03 Milestones 12/31/03
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Aphthasol(R) $ 752,000 $ 6,171,000 $ -
Zindaclin(R) $ 1,335,000 $ 897,000 $ 46,000
RISK FACTORS
This offering involves a high degree of risk. You should carefully
consider the risks described below and the other information in this
prospectus before purchasing our common stock.
We have experienced a history of losses and we expect to incur future losses.
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We have recorded minimal revenue to date and we have incurred a
cumulative operating loss of approximately $54.0 million through
December 31, 2003. Losses for the years ended 2003, 2002 and 2001
were $6,735,000, $9,384,000 and $6,027,000, respectively. Our losses
have resulted principally from costs incurred in research and development
activities related to our efforts to develop clinical candidates and from the
associated administrative costs. We expect to incur significant additional
operating losses over the next several years. We also expect cumulative
losses to increase due to expanded research and development efforts and
preclinical and clinical trials. Our net cash burn rate for the twelve months
of 2003 was $601,000 per month. We project our net cash burn rate for
the next twelve months to be approximately $400,000 per month. Capital
expenditures are forecasted to be minor for the next twelve months since
most of our new equipmentwebsite address is leased and the lease expense is included in
the calculation of the net cash burn rate.www.plasmatechbio.com. We do not have significant operating revenueincorporate by reference into this prospectus the information on our website, and you should not consider it as part of this prospectus.
Recent Developments
On April 7, 2015 we may never attain
profitability.
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To date,announced we have fundedhad appointed Charlie Strange, M.D. to our operations primarily throughScientific Advisory Board (SAB). Dr. Strange is a highly regarded thought leader in the Alpha-1 community, and has extensive clinical experience in designing and managing Alpha-1 clinical studies. We believe his advice and counsel will help accelerate development and approval of our proprietary SDF Alpha™ biologic drug.
On April 23, 2015 we closed a $7 million private salesplacement of common stock consisting of 2,333,333 shares of common stock, at a price of $3.00 per share.
On May 11, 2015 we closed a $10 million private placement of common stock consisting of 1,250,000 shares of common stock, at a price of $8.00 per share, and convertible notes. Contract researchwarrants to purchase 625,000 shares of common stock.
On May 5, 2015, the Company, Plasmatech Merger Sub Inc. (“Merger Sub”), a wholly owned subsidiary of the Company, Abeona Therapeutics LLC, an Ohio limited liability company (“Abeona”) and Paul A. Hawkins, an individual, solely in his capacity as Member Representative (“Member Representative”) entered into an Agreement and Plan of Merger (the “Merger Agreement”). Pursuant to the terms and subject to the conditions set forth in the Merger Agreement, Merger Sub will merge with and into Abeona, with Abeona continuing as the surviving corporation and becoming a wholly owned subsidiary of PlasmaTech (the “Merger”). The Board of Directors of PlasmaTech and Managers of Abeona have unanimously approved the transaction.
In connection with the Merger, the PlasmaTech will issue to Abeona members a total of 3,979,761 common shares upon closing of the transaction, and up to an additional $9 million in performance milestones, in common stock or cash, at the Company’s option. The completion of the Merger is subject to customary closing conditions.
On May 8, 2015, holders of warrants to purchase an aggregate of 665,950 shares of our common stock issued in our underwritten public offering, which closed on December 24, 201, exercised such warrants at a per share purchase price of $5.00. Proceeds from such exercise to us was $3,329,750 in cash.
Marketed Product
MuGard® is our marketed product for the management of oral mucositis, a frequent side-effect of cancer therapy for which there is no other established treatment. The market for mucositis treatment is estimated to be in excess of $1.0 billion worldwide. MuGard, a proprietary nanopolymer formulation, has received marketing clearance in the U.S. from the FDA. We launched MuGard in the U.S. in 2010.
Recent MuGard Developments
On August 5, 2010, we entered into an exclusive license with RHEI Pharmaceuticals, N.V. (“RHEI”) related to the commercialization of MuGard in China and other Southeast Asian countries. Our China partners have received an acceptance letter from the State Food and Drug Administration of the People’s Republic of China, which provides marketing approval in China. MuGard has been manufactured in the U.S. and shipped to China for sale. RHEI has rights to sub-license MuGard sales in some Southeast Asia countries.
On June 6, 2013 we entered into an exclusive license agreement with AMAG Pharmaceuticals, Inc. (“AMAG”), related to the commercialization of MuGard in the U.S. and its territories. Under the terms of the licensing agreement we received an upfront licensing fee of $3.3 million and will receive a tiered, double-digit royalty on net sales of MuGard in the licensed territory. We receive quarterly royalty payments from AMAG.
On March 11, 2014, we announced we had entered into an exclusive license agreement with Hanmi Pharmaceutical Co. Ltd. (“Hanmi”) related to MuGard commercialization in South Korea. Under the terms of the agreement, we received an upfront licensing fee and will receive double digit royalties on sales of MuGard in the licensed territory.
On July 8, 2014, we announced we received notification from the Hong Kong Patent Office that a patent for MuGard has been granted.
On August 7, 2014, we entered into an exclusive license agreement with Norgine B.V. (“Norgine”), a leading independent European specialty pharmaceutical company, for the commercialization of MuGard in Europe. Under the terms of the license agreement, we could receive up to $10 million in milestone payments and licensing fees from corporate alliances and mergers have also provided
funding for our operations. Our ability to achieve significant revenue or
profitability depends upon our ability to successfully completean escalating double digit royalty on the developmentnet sales of drug candidates, tothe oral mucositis product, MuGard, in the licensed territories. Norgine will develop, and obtain patent protection
and regulatory approvals for our drug candidates and to manufacture, and commercialize MuGard in the resulting drugs. We have notEuropean Union, Switzerland, Norway, Iceland and Lichtenstein. Norgine anticipates launching MuGard in 2015.
On September 12, 2014, we announced we had received significant
royalties for sales of amlexanox or Zindaclin(R) products
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to date and we may not generate significant revenues or profitsnotification from the saleEuropean Patent Office that an additional European patent for MuGard had been granted. The patent (EP1997478) protects a wide range of these products inliquid formulations for the future. Furthermore,prevention and treatment of mucosal diseases and disorders.
On October 27, 2014, we may not be able to ever successfully identify,
develop, commercialize, patent, manufacture, obtain
required regulatory approvals and market any additional products.
Moreover, even if we do identify, develop, commercialize, patent,
manufacture, and obtain required regulatory approvals to market additional
products, we may not generate revenues or royalties from commercial
sales of these productsentered into an exclusive license agreement with Norgine for a significant number of years, if at all.
Therefore, our proposed operations are subject to all the risks inherent in
the establishment of a new business enterprise. In the next few years, our
revenues may be limited to minimal royalties, any amounts that we
receive under strategic partnerships and research or drug development
collaborations that we may establish and, as a result, we may be unable
to achieve or maintain profitability in the future or to achieve significant
revenues in order to fund our operations.
We may not successfully commercialize our drug candidates.
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Our drug candidates are subject to the risks of failure inherent in the
development of pharmaceutical products based on new technologies and
our failure to develop safe, commercially viable drugs would severely
limit our ability to become profitable or to achieve significant revenues.
We may be unable to successfully commercialize our drug candidates
because:
* some or all of our drug candidates may be found to be unsafe or
ineffective or otherwise fail to meet applicable regulatory standards or
receive necessary regulatory clearances;
* our drug candidates, if safe and effective, may be too difficult to
develop into commercially viable drugs;
* it may be difficult to manufacture or market our drug candidates on a
large scale;
* proprietary rights of third parties may preclude us from marketing our
drug candidates; and
* third parties may market superior or equivalent drugs.
The success of our research and development activities, upon which we
primarily focus, is uncertain.
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Our primary focus is on our research and development activities and the commercialization of compounds covered by proprietary biopharmaceutical
patentsMuGard in Australia and patent applications. ResearchNew Zealand. The terms of the agreement are congruent to our recent license with Norgine for MuGard in Europe. Norgine intends to develop, manufacture and development activities, by
their nature, preclude definitive statements as to the time required and
costs involved in reaching certain objectives. Actual research and
development costs, therefore, could exceed budgeted amounts and
estimated time frames may require extension. Cost overruns, unanticipated
regulatory delays or demands, unexpected adverse side effects or
insufficient therapeutic efficacy will prevent or substantially slow our
research and development effort and our business could ultimately suffer.
We anticipate that we will remain principally engaged in research and
development activities for an indeterminate, but substantial, period of
time.
We may be unable to obtain necessary additional capital to fund operationscommercialize MuGard in the future.
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new territories.
On March 31, 2015, we announced that Hanmi has received marketing approval in Korea from the country’s Ministry of Food and Drug Safety and the Korea Testing & Research Institute for MuGard. Hanmi intends to market MuGard in Korea under the trade name Mucogard.
We require substantial capitalare actively seeking partners to license MuGard in other territories.
Product Candidates
| • | ProctiGardTM received 510(K) marketing clearance from the FDA on July 22, 2014 for the treatment of symptomatic management of rectal mucositis. ProctiGard is our product for the treatment of radiation proctitis, a frequent side effect of radiation treatment to the pelvic region. Radiation proctitis, or RP, is the inflammation and damage to the lower portion of the colon after exposure to x-rays or ionizing radiation as part of radiation therapy. RP is most common after treatments for cancer, such as cervical, colon and prostate cancer. RP can be acute, occurring within weeks of initiation of therapy, or can occur months or years after treatment. We intend to commercialize ProctiGard in a manner similar to the commercialization of MuGard, which may include confirmatory clinical trials, with the objective of commercialization in collaboration with marketing partners globally. |
| Compound | Originator | Technology | Indication | Clinical Stage | ||||
| MuGard® | PlasmaTech | Mucoadhesive liquid | Mucositis | — Launched in U.S. — Licensed to Norgine: Australia & New Zealand rights | ||||
| ProctiGardTM | PlasmaTech | Mucoadhesive hydrogel technology | Radiation proctitis | FDA clearance 7/22/14 | ||||
| Alpha-1 Protease Inhibitor (A1PI) | Licensor | Proprietary biological processing | Various | Process validation | ||||
| Intravenous immune globulin (IVIG) | Licensor | Proprietary biological processing | Various | Process validation |
Drug Development Strategy
We have a rich potential pipeline of our currently marketed products;
* the results of our research and development programs;
* the timing and results of preclinical and clinical trials;
* our ability to maintain existing and establish new collaborative
agreements with other companies to provide funding to us;
* technological advances; and
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* activities of competitors and other factors.
If we do raise additional funds by issuing equity securities, further dilution
to existing stockholders would result and future investors may be granted
rights superior to those of existing stockholders. If adequate funds are not
available to us through additional equity offerings, we may be required to
delay, reduce the scope of or eliminate one or more of our research and
development programs or to obtain funds by entering into arrangements
with collaborative partners or others that require us to issue additional
equity securities or to relinquish rights to certain technologies or drug
candidates that we would not otherwise issue or relinquish in order to
continue independent operations.
We may be unable to successfully develop, market, or commercialize our
products or our product candidates without establishing new relationships
and maintaining current relationships.
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Our strategy for the research, development and commercialization of our
potential pharmaceutical products may require us to enter into various
arrangements with corporate and academic collaborators, licensors,
licensees and others, in addition to our existing relationships with other
parties. Specifically, if we successfully develop any commercially
marketable pharmaceutical products, we may seek to enter joint venture,
sublicense or other marketing arrangements with parties that have an
established marketing capability or we may choose to pursue the
commercialization of such products on our own. We may, however, be
unable to establish such additional collaborative arrangements, license
agreements, or marketing agreements as we may deem necessary to
develop, commercialize and market our potential pharmaceutical products
on acceptable terms. Furthermore, if we maintain and establish
arrangements or relationships with third parties, our business may depend
upon the successful performance by these third parties of their
responsibilities under those arrangements and relationships. For our
commercialized products we currently rely upon the following
relationships in the following marketing territories:
* amlexanox 5% paste
o Strakan Ltd. - United Kingdom and Ireland manufacturing and
marketing rights
o Zambon Group - France, Germany, Holland, Belgium, Luxembourg,
Switzerland, Brazil, Colombia and Italy manufacturing and marketing
rights
o Laboratories Dr. Esteve SA - Spain, Portugal and Greece
manufacturing and marketing rights
o Meda, AB for Scandinavia, the Baltic states and Iceland marketing
rights
o Mipharm SpA for Italy manufacturing and marketing rights
o Paladin Labs, Inc. for Canada manufacturing and marketing rights
* Zindaclin(R) and Residerm(R)
o Strakan Ltd. - worldwide manufacturing and marketing rights
o Fujisawa GmbH - sublicensed continental Europe marketing rights
o Taro - sublicensed Israel marketing rights
o Various companies for other smaller countries - sublicensed marketing
rights
Our ability to successfully commercialize, and market our products and product candidates could be limited if a number of these existing
relationships were terminated.
Furthermore, our strategyranging from preclinical development candidates to one approved product. To maximize return on this portfolio, we plan to develop in-house or with respect to our polymer platinate program
is to entercollaborators the following products and technologies: MuGard, ProctiGard and mucoadhesive hydrogel technology.
SDF Licensed Technology
On September 22, 2014, we entered into aan exclusive, worldwide licensing agreement with a pharmaceutical company
pursuant to which the further costs of developing a product would be
shared with our licensing partner. Although we have had discussions with
potential licensing partners with respect to our polymer platinate program,
to date we have not entered into any licensing arrangement. We may be
unable to execute our licensing strategy for polymer platinate.
We may be unable to successfully manufacture our products and our
product candidates in clinical quantities or for commercial purposes
without the assistance of contract manufacturers, which may be difficult
for usLicensor to obtain rights to utilize and maintain.
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We have limited experience in the manufacture ofto sub-license to other pharmaceutical products
in clinical quantities or for commercial purposes and we may not be able
to manufacture any new pharmaceutical products that we may develop. As
a result, we have established, and in the future intend to establish
arrangements with contract manufacturers to supply sufficient quantities
of products to conduct clinical trials andfirms its patented methods for the manufacture, packaging,
labelingextraction of therapeutic biologics from human plasma. Plasma biologics are bio-pharmaceutical proteins extracted, purified, and distributionformulated from human blood plasma by the use of finished pharmaceutical products if any of our
potential productsbiotechnological processing techniques including precipitation, diafiltration, affinity chromatography, and ion-exchange chromatography. Because plasma biologics are approved for commercialization. If webiosimilar, they are unableless likely than recombinant or transgenic proteins to contract for a sufficient supply of our potential pharmaceutical products
on acceptable terms, our preclinical and human clinical testing schedule
may be delayed, resulting in the delay of our submission of products for
regulatory approval and initiation of new development programs, which
could cause our business to suffer. Delays or difficulties in establishing
relationships with manufacturers to produce, package, label and distribute
our finished pharmaceuticaltoxic or other medical products, if any, market
introduction and subsequent salesadverse reactions, or cause adverse immunological responses such as the stimulation of such products could cause our
business to suffer. Moreover, contract manufacturers that we may use
must adhere to current Good Manufacturing Practices, as required by the
FDA. In this regard, the FDA will not issue a pre-market approval or
product and establishment licenses, where applicable, to a manufacturing
facility for the products until after the manufacturing facility passes a pre-
approval plant inspection. If we are unable to obtain or retain third party
manufacturing on commercially acceptable terms, we may not be able to
commercialize our products as planned. Our potential dependence upon
third parties for the manufacture of our products may adversely affect our
profit margins and our ability to develop and deliver such products on a
timely and competitive basis.
Our amlexanox 5% paste is marketedinhibitors in the US as Aphthasol(R). Block
Drug Company had manufactured the 5% amlexanox paste since the
product was approved by the FDA in 1996 in a Puerto Rico facility
certified by the FDA for Good Manufacturing Practices. At such time
when we acquired the US rights to Aphthasol(R) we entered into a Supply
Agreement whereby Block Drug Company was to produce Aphthasol(R) for
us for a defined period of time at its Puerto Rico facility. We were
subsequently advised by Block Drug Company that it was unable to
comply withrecipients.
Under the terms of the Supply Agreement and that it would not be
able to produce Aphthasol(R) for us. Due to Block Drug Company's
production failure,licensing agreement, as amended on January 23, 2015, we had sufficient product to supply wholesalers only
through June 2003. We do not anticipate further salespaid a license fee of the product until
the second quarter$1 million in cash, will pay $4 million in cash or 1,096,151 shares of 2004. We acquired the rights to amlexanox 5% paste
from Block Drug Company on July 22, 2002. We have selected Contract
Pharmaceuticals Ltd. Canada as our new manufacturercommon stock in 2017, a regulatory approval milestone payment of amlexanox 5%
paste and it has produced initial qualifying batches513,375 shares of the product. Full
scale production commenced inour common stock upon the first quarter of 2004.
Amlexanox 5% paste was approved by regulatory authorities for sale in
the UK and is currently in the approval process in the remaining EU
countries. We licensed manufacturing rights to Strakan, Zambon, Esteve
and Mipharm for specific countries in Europe. Contract Pharmaceuticals
Ltd. Canada has also been selected as our European supplier of amlexanox
5% paste and a UK filing has been made to approve this facility for
European supply.
We licensed our patents for worldwide manufacturing and marketing for
Zindaclin(R) and the ResiDerm(R) technology to Strakan Ltd. for the
period of the patents. We receive a royalty on the sales of the product.
Strakan has a contract manufacturer for Zindaclin(R) in a European Union
approved facility. Zindaclin(R) was approved in the UK and seven
additional European Union countries and is currently under review for
approval in the remaining EU countries.
OraDisc(TM) was manufactured by a third party for our Phase III clinical
trials. Enough product was manufactured to cover the needs of the clinical
trials and testing. We finalized with a third party a contract for
manufacturing our product if our product gains regulatory approval.
AP5280 and AP5346 are manufactured by a third parties for our Phase
I/II clinical trials. Manufacturing is ongoing for the current clinical trials.
Certain manufacturing steps are conducted by the Company to enable
significant cost savings to be realized.
Our mucoadhesive technology is manufactured by a third party for our
clinical trials.
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We are subject to extensive governmental regulation which increases our
cost of doing business and may affect our ability to commercialize any
new products that we may develop.
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The FDA and comparable agencies in foreign countries impose substantial
requirements upon the introduction of pharmaceutical products through
lengthy and detailed laboratory, preclinical and clinical testing procedures
and other costly and time-consuming procedures to establish their safety
and efficacy. All of our drug candidates require governmental approvals
for commercialization. Preclinical and clinical trials and manufacturing of
our drug candidates will be subject to the rigorous testing and approval
processes of the FDA and corresponding foreign regulatory authorities.
Satisfaction of these requirements typically takes a significant number of
years and can vary substantially based upon the type, complexity and
novelty of the product. The status of our principal products is as follows:
* 5% amlexanox paste is an approved product for sale in the US
(Aphthasol(R)); approved in the UK and Canada but not yet sold; and, in
the approval process in the EU.
* Zindaclin(R) is an approved product for sale in the UK and seven
additional European Union countries; in the approval process in the
remaining EU countries; and waiting for finalized plans and approval to
start a Phase III trial in the US.
* OraDisc(TM) has completed a Phase III clinical trial in the US and we
filed an NDA.
* AP5280 has completed Phase I of its Phase I/II trial in Europe and we
are analyzing the results to start the Phase II part of the trial.
* AP5346 is currently in a Phase I trial in Europe.
* Mucoadhesive liquid technology is planned to start a Phase III trial in
the US in the second quarter of 2004.
* Vitamin mediated delivery technology is currently in the pre-clinical
phase.
* We also have other products in the preclinical phase.
Due to the time consuming and uncertain nature of the drug candidate
development process and the governmental approval process described
above, we cannot assure you when we, independently or with our
collaborative partners, might submit a New Drug Application, or "NDA",
for FDA or other regulatory review.
Government regulation also affects the manufacturing and marketing of
pharmaceutical products. Government regulations may delay marketing of
our potential drugs for a considerable or indefinite period of time, impose
costly procedural requirements upon our activities and furnish a
competitive advantage to larger companies or companies more experienced
in regulatory affairs. Delays in obtaining governmental regulatory
approval could adversely affect our marketing as well as our ability to
generate significant revenues from commercial sales. Our drug candidates
may not receive FDA or other regulatory approvals on a timely basis or
at all. Moreover, if regulatory approval of a drug candidate is granted,
such approval may impose limitations on the indicated use for which such
drug may be marketed. Even if we obtain initial regulatory approvals for
our drug candidates, Access, and our drugs and our manufacturing
facilities would be subject to continual review and periodic inspection, and
later discovery of previously unknown problems with a drug,
manufacturer or facility may result in restrictions on the marketing or
manufacture of such drug, including withdrawal of the drugderived from the market. The FDALicensor’s proprietary SDF process, and a tiered royalty on annual net sales of plasma fractions produced with Licensor’s proprietary SDF process.
Licensor was founded to develop superior high-yield technology to extract a wide range of therapeutically useful proteins from human blood plasma. We believe that Licensor’s proprietary SDF process is expected to significantly enhance yields of key value blood proteins, including alpha-1 protease inhibitor (“A1PI”), expanding market opportunities, while greatly enhancing margins. We obtained rights to utilize and sub-license to other regulatory authorities stringently apply
regulatory standards and failure to comply with regulatory standards can,pharmaceutical firms the recently patented improved methods for the extraction of therapeutic biologics from human plasma. We believe that Licensor’s lead product, A1PI offers a low-risk, high revenue, short time-to-market respiratory product for treatment of inherited COPD (pulmonary emphysema), among other things, result in fines, denial or withdrawal of regulatory
approvals, product recalls or seizures, operating restrictions and criminal
prosecution.
The uncertainty associated with preclinical and clinical testing may affect
ourgenetic A1PI deficiencies. Additionally, the ability to successfully commercialize new products.
- ---------------------------------------------------------------------------
Before we can obtain regulatory approvals for the commercial sale of any
of our potential drugs, the drug candidates will be subject to extensive
preclinicalextract several additional therapeutically useful and clinical trials to demonstrate their safety and efficacy in
humans. Preclinical or clinical trials of any of our future drug candidates
may not demonstrate the safety and efficacy of such drug candidates at all
or to the extent necessary to obtain regulatory
7
approvals. In this regard, for example, adverse side effects
can occur during the clinical testing of
a new drug on humans which may delay ultimate FDA approval or even
lead us to terminate our efforts to develop the drug for commercial use.
Companies in the biotechnology industry have suffered significant setbacks
in advanced clinical trials, even after demonstrating promising results in
earlier trials. In particular, OraDisc(TM) and AP5280 have taken longer
to progress through clinical trials than originally planned. This extra time
has not been related to concerns of the formulations but ratherimportant proteins, due to the lengthy regulatory process. The failureprocess being less destructive than historical fractionation processes, may enable us to adequately demonstrate the
safetyseek new therapeutic applications and efficacy of a drug candidate under development could delay or
prevent regulatory approval of the drug candidate. A delay or failure to
receive regulatory approval for any of our drug candidates could prevent
us from successfully commercializing such candidates and we could incur
substantial additional expensesaddress high-value-added orphan indications.
An investment in our attemptssecurities involves risks. We urge you to further developconsider carefully the risks described in the documents incorporated by reference in this prospectus before making an investment decision, including those risks identified under “Item IA. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2014, filed with the Securities and Exchange Commission on March 31, 2015, which report is incorporated by reference in this prospectus, as such candidates and obtain future regulatory approval.
We may incur substantial product liability expenses due to the use or
misuse of our products for which weinformation may be unableamended, supplemented or superseded from time to obtain insurance
coverage.
- ----------------------------------------------------------------------
Our business exposes us to potential liability riskstime by other reports that we subsequently file with the Securities and Exchange Commission.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus and the other documents we have filed with the SEC that are inherent in the
testing, manufacturing and marketing of pharmaceutical products. These
risks will expand with respect to our drug candidates, if any, that receive
regulatory approval for commercial sale and we may face substantial
liability for damages in the event of adverse side effects or product defects
identified with any of our products that are used in clinical tests or
marketed to the public. We generally procure product liability insurance
for drug candidates that are undergoing human clinical trials. Product
liability insurance for the biotechnology industry is generally expensive,
if available at all, and as a result, we may be unable to obtain insurance
coverage at acceptable costs or in a sufficient amount in the future, if at
all. We may be unable to satisfy any claims for which we may be held
liable as a result of the use or misuse of products which we have
developed, manufactured or sold and any such product liability claim
could adversely affect our business, operating results or financial
condition.
We may incur significant liabilities if we fail to comply with stringent
environmental regulations or if we did not comply with these regulations
in the past.
- ------------------------------------------------------------------------
Our research and development processes involve the controlled use of
hazardous materials. We are subject to a variety of federal, state and local
governmental laws and regulations related to the use, manufacture,
storage, handling and disposal of such material and certain waste products.
Although we believe that our activities and our safety procedures for
storing, using, handling and disposing of such materials comply with the
standards prescribedincorporated herein by such laws and regulations, the risk of accidental
contamination or injury from these materials cannot be completely
eliminated. In the event of such accident, we could be held liable for any
damages that result and any such liability could exceed our resources.
Intense competition may limit our ability to successfully develop and
market commercial products.
- ----------------------------------------------------------------------
The biotechnology and pharmaceutical industries are intensely competitive
and subject to rapid and significant technological change. Our competitors
in the United States and elsewhere are numerous and include, among
others, major multinational pharmaceutical and chemical companies,
specialized biotechnology firms and universities and other research
institutions.
The following products may compete with polymer platinum (AP5280)
and DACH platinum (AP5346):
* Cisplatin, marketed by Bristol-Myers-Squibb, the originator of the drug,
and several generic manufacturers;
* Carboplatin, marketed exclusively by Bristol-Myers-Squibb; and
* Oxaliplatin, marketed exclusively by Sanofi-Synthelabo.
The following companies are working on therapies and formulations that
may be competitive with our polymer platinum (AP5280) and DACH
platinum (AP5346):
8
* Antigenics is developing liposomal formulations; and
* Cell Therapeutics, Daiichi, Enzon and Inhale are developing alternate
drugs in combination with polymers.
The following products may compete with our Residerm(R) products:
* Benzamycin, marketed by a subsidiary of Aventis;
* Cleocin-T and a generic topical clindamycin, marketed by Pharmacia;
* Benzac, marketed by a subsidiary of L'Oreal; and
* Triaz, marketed by Medicis Pharmaceutical Corp.
Technology and prescription steroids such as Kenalog in OraBase,
developed by Bristol-Myers Squibb, may compete with our
commercialized Aphthasol(R) product. OTC products including Orajel - Del
Laboratories and Anbesol - Wyeth Consumer Healthcare also compete in
the aphthous ulcer market.
Companies working on therapies and formulations that may be competitive
with our vitamin mediated drug delivery system are Bristol-Myers-Squibb,
Centocor (acquired by Johnson & Johnson), GlaxoSmithKline, Imclone
and Xoma which are developing targeted monoclonal antibody therapy.
RxKinetics, Human Genome Sciences, Endo Pharmaceuticals and Amgen
are developing products to treat mucositis that may compete with the
mucoadhesive liquid technology.
Emisphere Technologies, Inc., Biovail Corporation, CIMA Labs, Inc.,
Depomed Inc. and Flamel Technologies are developing products which
compete with our oral drug delivery system.
Many of these competitors have and employ greater financial and other
resources, including larger research and development staffs and more
effective marketing and manufacturing organizations, than us or our
collaborative partners. As a result, our competitors may successfully
develop technologies and drugs that are more effective or less costly than
any that we are developing or which would render our technology and
future products obsolete and noncompetitive.
In addition, some of our competitors have greater experience than we do
in conducting preclinical and clinical trials and obtaining FDA and other
regulatory approvals. Accordingly, our competitors may succeed in
obtaining FDA or other regulatory approvals for drug candidates more
rapidly than we do. Companies that complete clinical trials, obtain
required regulatory agency approvals and commence commercial sale of
their drugs before their competitors may achieve a significant competitive
advantage. Drugs resulting from our research and development efforts or
from our joint efforts with collaborative partners therefore may not be
commercially competitive with our competitors' existing products or
products under development.
Our ability to successfully develop and commercialize our drug candidates
will substantially depend upon the availability of reimbursement funds for
the costs of the resulting drugs and related treatments.
- --------------------------------------------------------------------------
The successful commercialization of, and the interest of potential
collaborative partners to invest in, the development of our drug candidates
will depend substantially upon reimbursement of the costs of the resulting
drugs and related treatments at acceptable levels from government
authorities, private health insurers and other organizations, including
health maintenance organizations, or HMOs. To date, the costs of our
marketed products Aphthasol(R) and Zindaclin(R) generally have been
reimbursed at acceptable levels, however, the amount of such
reimbursement in the United States or elsewhere may be decreased in the
future or may be unavailable for any drugs that we may develop in the
future. Limited reimbursement for the cost of any drugs that we develop
may reduce the demand for, or price of such drugs, which would hamper
our ability to obtain collaborative partners to commercialize our drugs, or
to obtain a sufficient financial return on our own manufacture and
commercialization of any future drugs.
9
The market may not accept any pharmaceutical products that we
successfully develop.
- -------------------------------------------------------------
The drugs that we are attempting to develop may compete with a number
of well-established drugs manufactured and marketed by major
pharmaceutical companies. The degree of market acceptance of any drugs
developed by us will depend on a number of factors, including the
establishment and demonstration of the clinical efficacy and safety of our
drug candidates, the potential advantage of our drug candidates over
existing therapies and the reimbursement policies of government and third-
party payers. Physicians, patients or the medical community in general
may not accept or use any drugs that we may develop independently or
with our collaborative partners and if they do not, our business could
suffer.
In 1996, the 5% amlexanox paste product was approved for sale in the
United States. To date, the product is not widely accepted in the
marketplace and its sales have not been significant. On July 22, 2002, we
acquired the rights to it from Block Drug Company and we intend to re-
launch it in the second quarter of 2004. The product has been approved
in the UK and Canada but has not been launched in any markets other
than the United States.
Trends toward managed health care and downward price pressures on
medical products and services may limit our ability to profitably sell any
drugs that we may develop.
- --------------------------------------------------------------------------
Lower prices for pharmaceutical products may result from:
* third-party payers' increasing challenges to the prices charged for
medical products and services;
* the trend toward managed health care in the United States and the
concurrent growth of HMOs and similar organizations that can control or
significantly influence the purchase of healthcare services and products;
and
* legislative proposals to reform healthcare or reduce government
insurance programs.
The cost containment measures that healthcare providers are instituting,
including practice protocols and guidelines and clinical pathways, and the
effect of any health care reform, could limit our ability to profitably sell
any drugs that we may successfully develop. Moreover, any future
legislation or regulation, if any, relating to the healthcare industry or
third-party coverage and reimbursement, may cause our business to suffer.
We may not be successful in protecting our intellectual property and
proprietary rights.
- --------------------------------------------------------------------
Our success depends, in part, on our ability to obtain U.S. and foreign
patent protection for our drug candidates and processes, preserve our trade
secrets and operate our business without infringing the proprietary rights
of third parties. Legal standards relating to the validity of patents covering
pharmaceutical and biotechnological inventions and the scope of claims
made under such patents are still developing and there is no consistent
policy regarding the breadth of claims allowed in biotechnology patents.
The patent position of a biotechnology firm is highly uncertain and
involves complex legal and factual questions. We cannot assure you that
any existing or future patents issued to, or licensed by, us will not
subsequently be challenged, infringed upon, invalidated or circumvented
by others. As a result, although we, together with our subsidiaries, are
either the owner or licensee of technology to 26 U.S. patents and to 16
U.S. patent applications now pending, and 7 European patents and 17
European patent applications, we cannot assure you that any additional
patents will issue from any of the patent applications owned by, or
licensed to, us. Furthermore, any rights that we may have under issued
patents may not provide us with significant protection against competitive
products or otherwise be commercially viable.
Our patents for the following technologies expire in the years and during
the date ranges indicated below:
10
* 5% amlexanox paste in 2011
* Zindaclin(R) and Residerm(R) between 2007 and 2011
* OraDisc(TM) in 2020
* AP5280 in 2021
* AP5346 in 2021
* Mucoadhesive technology, patents are pending
* Vitamin mediated technology between 2003 and 2019
In addition, patents may have been granted to third parties or may be
granted covering products or processes that are necessary or useful to the
development of our drug candidates. If our drug candidates or processes
are found to infringe upon the patents or otherwise impermissibly utilize
the intellectual property of others, our development, manufacture and sale
of such drug candidates could be severely restricted or prohibited. In such
event, we may be required to obtain licenses from third parties to utilize
the patents or proprietary rights of others. We cannot assure you that we
will be able to obtain such licenses on acceptable terms, if at all. If we
become involved in litigation regarding our intellectual property rights or
the intellectual property rights of others, the potential cost of such
litigation, regardless of the strength of our legal position, and the potential
damages that we could be required to pay could be substantial.
Our business could suffer if we lose the services of, or fail to attract, key
personnel.
- -----------------------------------------------------------------------------
We are highly dependent upon the efforts of our senior management and
scientific team, including our President and Chief Executive Officer,
Kerry Gray. The loss of the services of one or more of these individuals
could delay or prevent the achievement of our research, development,
marketing, or product commercialization objectives. While we have
employment agreements with Mr. Gray and David Nowotnik our Senior
Vice President Research and Development, their employment may be
terminated by them or us at any time. Mr. Gray's and Dr. Nowotnik's
agreements expire within one year and are extendable each year on the
anniversary date. We do not have employment contracts with our other
key personnel. We do not maintain any "key-man" insurance policies on
any of our key employees and we do not intend to obtain such insurance.
In addition, due to the specialized scientific nature of our business, we are
highly dependent upon our ability to attract and retain qualified scientific
and technical personnel. In view of the stage of our development and our
research and development programs, we have restricted our hiring to
research scientists and a small administrative staff and we have made no
investment in manufacturing, production, marketing, product sales or
regulatory compliance resources. If we develop pharmaceutical products
that we will commercialize ourselves, however, we will need to hire
additional personnel skilled in the clinical testing and regulatory
compliance process and in marketing and product sales. There is intense
competition among major pharmaceutical and chemical companies,
specialized biotechnology firms and universities and other research
institutions for qualified personnel in the areas of our activities, however,
and we may be unsuccessful in attracting and retaining these personnel.
Ownership of our shares is concentrated, to some extent, in the hands of
a few investors which could limit the ability of our other stockholders to
influence the direction of the company.
- --------------------------------------------------------------------------
Heartland Advisors, Inc. and Larry N. Feinberg (Oracle Partners LP,
Oracle Institutional Partners LP and Oracle Investment Management Inc.)
each currently beneficially own approximately 12.1% of our common
stock as of March 22, 2004. Accordingly, they collectively may have the
ability to significantly influence or determine the election of all of our
directors or the outcome of most corporate actions requiring stockholder
approval. They may exercise this ability in a manner that advances their
best interests and not necessarily those of our other stockholders.
Provisions of our charter documents could discourage an acquisition of
our company that would benefit our stockholders and may have the effect
of entrenching, and making it difficult to remove, management.
- -----------------------------------------------------------------------
Provisions of our Certificate of Incorporation, By-laws and Stockholders
Rights Plan may make it more difficult for a third party to acquire control
of our company, even if a change in control would benefit
11
our stockholders. In particular, shares of our preferred stock may be issued
in the future without further stockholder approval and upon such terms
and conditions, and having such rights, privileges and preferences, as our
Board of Directors may determine, including, for example, rights to
convert into our common stock. The rights of the holders of our common
stock will be subject to, and may be adversely affected by, the rights of
the holders of any of our preferred stock that may be issued in the future.
The issuance of our preferred stock, while providing desirable flexibility
in connection with possible acquisitions and other corporate purposes,
could have the effect of making it more difficult for a third party to
acquire control of us. This could limit the price that certain investors
might be willing to pay in the future for shares of our common stock and
discourage these investors from acquiring a majority of our common
stock. Further, the existence of these corporate governance provisions
could have the effect of entrenching management and making it more
difficult to change our management.
Substantial sales of our common stock could lower our stock price.
- ------------------------------------------------------------------
The market price for our common stock could drop as a result of sales of
a large number of our presently outstanding shares. Of the 15,314,816 shares
of our common stock that are outstanding as of March 22, 2004, 13,525,445
are unrestricted and freely tradable or tradable pursuant to a
resale registration statement or under Rule 144 of the Securities Act. An
additional 1,789,371 shares of common stock that are outstanding as of
March 22, 2004 are being registered hereunder and, upon effectiveness of
the registration statement of which this prospectus forms a part, will be
eligible for public resale.
We are not currently in compliance with AMEX continued listing
requirements and may not be able to maintain our AMEX listing.
- --------------------------------------------------------------
Our common stock is presently listed on the American Stock Exchange
under the symbol "AKC". All companies listed on AMEX are required to
comply with certain continued listing standards, including maintaining
stockholders' equity at required levels. We are not in compliance with this
stockholders' equity standard as of December 31, 2003. However, we
have until November 2004 to become compliant with such equity standard.
If we are unable to remedy any listing standard noncompliance with
AMEX under its regulations, or otherwise regain compliance, we cannot
assure you that our common stock will continue to remain eligible for
listing on AMEX. In the event that our common stock is delisted from
AMEX its market value and liquidity could be materially adversely
affected.
FORWARD LOOKING STATEMENTS
This prospectus containsreference contain forward-looking statements that involve substantial risks and uncertainties. TheseAll statements, relate toother than statements of historical facts, regarding our strategy, future events or ouroperations, future financial performance. In some cases, you canposition, future revenues, projected costs, prospects, plans, objectives of management or other financial items are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this prospectus, particularly as set forth and incorporated by terminology such as "may," "will," "should," "expects,"
"plans," "could", "anticipates," "believes," "estimates," "predicts,"
"potential" or "continue" orreference in the negative of such terms or other
comparable terminology. These statements are only predictions and
involve known and unknown risks, uncertainties and other factors,
including the risks outlined under "Risk Factors,"“Risk Factors” section above, that maywe believe could cause our or
our industry's actual results levelsor events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of activity, performanceany future acquisitions, mergers, dispositions, joint ventures, collaborations or achievements toinvestments we may make.
You should read this prospectus and the documents that we incorporate by reference in this prospectus completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any future results, levels or
activity, performance or achievements expressed or implied by such
forward-looking statements.
Although we believe that the expectations reflected in the forward-looking
statements are reasonable, we cannot guarantee future results, levels of
activity, performance or achievements. We are under no dutyobligation to update any offorward-looking statements,except as otherwise required by law. We advise you, however, to consult any further disclosures we make on related subjects in our future annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K we file with or furnish to the forward-looking statements after the date of this prospectus to
conform such statements to actual results.
12
SEC.
We will not receive any cash proceeds from the sale of shares by the Selling
Stockholders. We will receive proceeds from the exercise of warrants if
payment is made in cash. All such proceeds will be used for general
corporate purposes.
SELLING STOCKHOLDERS
The following table sets forth certain information regarding the beneficial
ownership of our common stock asby the selling stockholders pursuant to this prospectus. The selling stockholders will bear any underwriting commissions and discounts attributable to their sale of March 22, 2004 and as adjusted to
reflect the saleshares of our common stock offered hereby, bystock.
As of the Selling
Stockholders.date of this prospectus, the selling stockholders collectively hold 1,250,000 shares of our Common Stock and warrants to purchase 675,000 of our shares of Common Stock. The Selling Stockholders, other than HCFP-Brenner Securities, LLC and
SCO Securities, LLC whowarrants were distributed to the placement agentsselling stockholders in our recentconnection with the private placement, have not had any position, office or other material relationship
withinwhich closed on May 11, 2015. Pursuant to a registration rights agreement entered into among the past three years with us or our affiliates. In addition,Company and the selling stockholders, we
believe, based on information provided to us by the Selling Stockholders,
that each of the Selling Stockholders, except as noted below, have sole
voting and investment power with respect to the shares beneficially
owned. For more information regarding the shares offered, see "Plan of
Distribution" below.
The table below describes the selling stockholders’ beneficial ownership of our common stock (i) as of the date of this prospectus and (ii) assuming the selling stockholders have exercised the warrants to purchase shares of our common stock and resold such shares of common stock pursuant to this prospectus. The selling stockholders may sell some, all or none of its shares in this offering.
| Beneficial Ownership Prior to this Offering (1) | Beneficial Ownership After to this Offering (1)(3) | |||||||||||||
| Name and Address of Selling Stockholder | Number of Shares of Common Stock (2) | Percentage of Common Stock | Number of Shares of Common Stock (2) | Percentage of Common Stock | ||||||||||
| Sabby Volatility Warrant Master Fund Ltd (4) (5) | 825,000 | * | — | — | ||||||||||
| Sabby Healthcare Master Fund Ltd (4) (5) | 1,050,000 | * | — | — | ||||||||||
| Michael Vasinkevich (6) | 17,250 | * | — | — | ||||||||||
| Noam Rubinstein (6) | 15,750 | * | — | — | ||||||||||
| H. C. Wainwright & Co., LLC (6) | 15,000 | * | — | — | ||||||||||
| Mark Viklund (6) | 1,500 | * | — | — | ||||||||||
| Charles Worthman (6) | 500 | * | — | — | ||||||||||
| * | Less than one percent |
| (1) | Beneficial ownership is determined in accordance with Rule 13d-3(d) promulgated by the SEC under the Securities and Exchange Act of 1934, as amended, or the Exchange Act. Unless otherwise noted, each person or group identified, possesses sole voting and investment power with respect to the shares. In calculating the number of shares beneficially owned by each selling stockholder prior to and after this offering, we have based our calculations on 24,268,085 shares of common stock outstanding as of May 14, 2015. | |
| (2) | Assumes the exercise of underlying warrants. | |
| (3) | Assumes exercise of underlying warrants and the sale of all shares of common stock by the selling stockholders pursuant to this prospectus. | |
| (4) | Sabby Healthcare Master Fund, Ltd. (“SHMF”) and Sabby Volatility Warrant Master Fund, Ltd. (“SVWMF”) have indicated to us that Hal Mintz has voting and investment power over the shares held by each fund. SHMF and SVWMF have also indicated to us that Sabby Management, LLC serves as the investment manager of SHMF and SVWMF, that Hal Mintz is the manager of Sabby Management, LLC and that each of Sabby Management, LLC and Hal Mintz disclaim beneficial ownership over these shares except to the extent of any pecuniary interest therein. | |
| (5) | The address for each of the Sabby funds is c/o Sabby Management, LLC, 10 Mountainview Road, Ste 205, Upper Saddle River, NJ 07458. | |
| (6) | The address of such selling stockholder is c/o H.C. Wainwright & Co., LLC, 430 Park Avenue, New York, NY 10022. |
| 8 |
Each Selling Stockholders. SalesStockholder (the “Selling Stockholders”) of sharesthe securities and any of their pledgees, assignees and successors-in-interest may, be made by Selling Stockholders,
including their respective donees, transferees, pledgees or other
successors-in-interest directly to purchasers or to or through underwriters,
broker-dealers or through agents. Sales may be made from time to time, sell any or all of their securities covered hereby on the American Stock Exchange,The NASDAQ Capital Market or any other stock exchange, or market upon
which our shares may trade in the future, in the over-the-counter market or otherwise, at market prices prevailing attrading facility on which the time of sale, at prices
related to market prices,securities are traded or at negotiated or fixed prices. The sharesin private transactions. These sales may be sold byat fixed or negotiated prices. A Selling Stockholder may use any one or more of the following methods when selling securities:
| · | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
| · | block trades in which the broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
| · | purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
| · | an exchange distribution in accordance with the rules of the applicable exchange; |
| · | privately negotiated transactions; |
| · | settlement of short sales; |
| · | in transactions through broker-dealers that agree with the Selling Stockholders to sell a specified number of such securities at a stipulated price per security; |
| · | through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
| · | a combination of any such methods of sale; or |
| · | any other method permitted pursuant to applicable law. |
The Selling Stockholders may also sell securities under Rule 144 under the Securities Act of 1933, as amended (the “Securities Act”), if available, rather than under this prospectus.
Broker-dealers engaged by the Selling Stockholders may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive commissions or a combination of,discounts from the following:
* a block trade in which theSelling Stockholders (or, if any broker-dealer so engaged will attempt to sell
the shares as agent but may position and resell a portion of the block as
principal to facilitate the transaction (including crosses in which the same
broker acts as agent for both sidesthe purchaser of securities, from the transaction);
* purchases bypurchaser) in amounts to be negotiated, but, except as set forth in a broker-dealer as principal and resale by such broker-
dealer, including
14
resales for its account, pursuantsupplement to this prospectus;
* ordinary brokerage transactions and transactions in which the broker
solicits purchases;
* through options, swaps or derivatives;
* in privately negotiated transactions;
* in making short sales or in transactions to cover short sales; and
* put or call option transactions relating to the shares.
The Selling Stockholders may effect these transactions by selling shares
directly to purchasers or to or through broker-dealers, which may act as
agents or principals. These broker-dealers may receive compensationProspectus, in the formcase of discounts, concessions or commissions from the Selling
Stockholders and/or the purchasers of shares for whom such broker-
dealers may act as agents or to whom they sell as principals, or both
(which compensation as to a particular broker-dealer might bean agency transaction not in excess of a customary commissions). The Selling Stockholders have advised us that
they have not entered into any agreements, understandingsbrokerage commission in compliance with FINRA Rule 2440; and in the case of a principal transaction a markup or arrangementsmarkdown in compliance with any underwriters or broker-dealers regardingFINRA IM-2440.
In connection with the sale of their securities.
Thethe securities or interests therein, the Selling Stockholders may enter into hedging transactions with broker-
dealers or other financial institutions. In connection with those
transactions, the broker-dealers or other financial institutions, which may in turn engage in short sales of the shares or of securities convertible into or
exchangeable for the shares in the course of hedging the positions they assume
withassume. The Selling Stockholders may also sell securities short and deliver these securities to close out their short positions, or loan or pledge the Selling Stockholders.securities to broker-dealers that in turn may sell these securities. The Selling Stockholders may also enter into optionsoption or other transactions with broker-dealers or other financial institutions or create one or more derivative securities which require the delivery to such broker-dealer or other financial institution of sharessecurities offered by this prospectus, to those broker-dealers or other financial institutions. Thewhich securities such broker-dealer or other financial institution may then resell the shares pursuant to this prospectus (as amendedsupplemented or supplemented, if required by applicable law,amended to reflect those transactions)such transaction).
The Selling Stockholders and any broker-dealers or agents that actare involved in connection
withselling the sale of sharessecurities may be deemed to be "underwriters"“underwriters” within the meaning of Section 2(11) of the Securities Act of 1933, andin connection with such sales. In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the shares soldsecurities purchased by them while acting as principals may be deemed to be underwriting discountscommissions or commissionsdiscounts under the Securities Act. Each Selling Stockholder has informed the Company that it does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the securities.
The Company is required to pay certain fees and expenses incurred by the Company incident to the registration of the securities. The Company has agreed to indemnify the Selling Stockholders may agree to indemnify any agent, dealer or broker-
dealer that participates in transactions involving sales of the shares against certain losses, claims, damages and liabilities, including liabilities arising under the Securities Act.
We have agreed to indemnify eachkeep this prospectus effective until the earlier of (i) the date on which the securities may be resold by the Selling Stockholders without registration and each selling
security holder has agreed, severally and not jointly,without regard to indemnify us
against some liabilitiesany volume or manner-of-sale limitations by reason of Rule 144, without the requirement for the Company to be in connectioncompliance with the offering of the shares,
including liabilities arisingcurrent public information under Rule 144 under the Securities Act.Act or any other rule of similar effect or (ii) all of the securities have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule of similar effect. The resale securities will be sold only through registered or licensed brokers or dealers if required under applicable state securities laws. In addition, in certain states, the resale securities covered hereby may not be sold unless they have been registered or qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available and is complied with.
Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities may not simultaneously engage in market making activities with respect to the common stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution. In addition, the Selling Stockholders will be subject to the prospectus delivery
requirementsapplicable provisions of the Securities Act. We have informedExchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of the common stock by the Selling Stockholders thator any other person. We will make copies of this prospectus available to the anti-manipulative provisionsSelling Stockholders and have informed them of Regulation M
promulgatedthe need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the Securities Exchange Act of 1934Act).
WHERE YOU CAN FIND MORE INFORMATION; INCORPORATION BY REFERENCE
We file annual, quarterly and current reports, proxy statements and other information with the SEC. You may apply to their
sales inread and copy information filed by us with the market.
Selling Stockholders also may resell all or a portionSEC at the SEC’s public reference section, 100 F Street, N.E., Washington, D.C. 20549. Information regarding the operation of the shares in open
market transactions in reliance upon Rule 144 underpublic reference section can be obtained by calling 1-800-SEC-0330. The SEC also maintains an Internet site at http://www.sec.gov that contains reports, statements and other information about issuers, such as us, who file electronically with the Securities Act,
provided they meet the criteria and conform to the requirements of Rule
144.
Upon being notified by a selling security holder that a material
arrangement has been entered into with a broker-dealer for the sale of
shares through a block trade, special offering, exchange distribution or
secondary distribution or a purchase by a broker or dealer, we will file a
supplement to this prospectus, if required pursuant to Rule 424(b) under
the Securities Act, disclosing:
* the name of each such selling security holder and of the participating
broker-dealer(s);
15
* the number of shares involved;
* the initial priceSEC. We maintain an Internet site at which the shares were sold;
* the commissions paid or discounts or concessions allowed to the broker-
dealer(s), where applicable;
* that such broker-dealer(s) did not conduct any investigation to verifyhttp://www.plasmatechbio.com. However, the information set out oron our Internet site is not incorporated by reference in this prospectus;prospectus and * other facts material to the transactions.
In addition, if required under applicable law or the rules or regulations of
the Commission, we will file aany prospectus supplement to this prospectus when a
selling security holder notifies us that a donee or pledgee intends to sell
more than 500 shares of common stock.
We are paying all expenses and fees customarily paid by the issuer in
connection with the registration of the shares. The Selling Stockholders
will bear all brokerage or underwriting discounts or commissions paid to
broker-dealers in connection with the sale of the shares.
LEGAL MATTERS
The validity of our common stock to be sold in this offering is being
passed upon for us by Bingham McCutchen LLP, 150 Federal Street,
Boston, Massachusetts 02110. Justin P. Morreale, David L. Engel and
John J. Concannon III, partners of Bingham McCutchen LLP, beneficially
own an aggregate of 208,533 shares of our common stock. Mr.
Concannon is our corporate Secretary.
EXPERTS
Our consolidated financial statements incorporated in this prospectus by
reference to our Annual Report on Form 10-K for the period ended
December 31, 2003 have been so incorporated in reliance on the report
of Grant Thornton LLP, independent certified public accountants, given
on the authority of said firm as experts in accounting and auditing.
WHERE YOU CAN GET MORE INFORMATION
This prospectus constitutesyou should not consider it a part of a registration statement on Form S-3
filedthis prospectus or any accompanying prospectus supplement.
The SEC allows us to “incorporate by us with the Securities and Exchange Commission, or SEC, under
the Securities Act of 1933. Thisreference” into this prospectus does not contain all of the information set forth in the Registration Statement, since we have omitted
some parts in accordance with the SEC's rules and regulations. The SEC
permits us to "incorporate by reference" the informationother documents that we file with it,
whichit. This means that we can disclose important information to you by referring you to those documents. The information incorporated by reference is an importantconsidered to be a part of this prospectus, and information in documents that we file later with the SEC will automatically update and supersede information contained in documents filed earlier with the SEC or contained in this information. Access hasprospectus. We incorporate by reference in this prospectus the documents listed below and any future filings that we may make with the SEC under Sections 13(a), 13(c), 14, or 15(d) of the Exchange Act prior to the termination of the offering under this prospectus; provided, however, that we are not incorporating, in each case, any documents or information deemed to have been furnished and not filed ain accordance with SEC rules:
All reports and other documents we subsequently file pursuant to this prospectus. This prospectus omits certain
information contained inSection 13(a), 13(c), 14 or 15(d) of the Registration Statement on Form S-3, as
permitted by the SEC. ReferExchange Act prior to the Registration Statement on Form S-3,termination of this offering, including all such documents we may file with the exhibits, for furtherSEC after the date of the initial registration statement and prior to the effectiveness of the registration statement, but excluding any information about Access and the
common stock being offered pursuantfurnished to, this prospectus. Statements in this
prospectus regarding provisions of certain documentsrather than filed with, orthe SEC, will also be incorporated by reference in, the Registration Statement are not
necessarily completeinto this prospectus and each statement is qualified in all respects by that
reference. Copies of all or anydeemed to be part of this prospectus from the Registration Statement,
including the
16
documents incorporated by reference or the exhibits, may be
obtained without charge at the officesdate of the SEC listed below.
We are subject to the reporting requirementsfiling of the Securities Exchange
Act of 1934such reports and we therefore file annual, quarterly and special reports,
proxy statements and other information with the SEC. You may read and
copy any document we file at the public reference facilities of the SEC
located at 450 Fifth Street N.W., Washington D.C. 20549. documents.
You may obtain information on the operation of the SEC's public reference facilities
by calling the SEC at 1-800-SEC-0330. You can also access copies of
such material electronically on the SEC's home page on the World Wide
Web at http://www.sec.gov.
If you request a copy of any or all of the documents referred to above which may have been or may be incorporated by reference then we will send to you the copies you requested at no charge.
However, we will not sendinto this prospectus, except for exhibits to suchthose documents unless such(unless the exhibits are specifically incorporated by reference in such documents. We
will also provideinto those documents) at no cost to each person to whom a copy of this prospectus has
been delivered, upon specific request and without charge, a copy of all
documents filed from time to timeyou by writing or telephoning us withat the SEC pursuant to the
Securities Exchange Act of 1934. You should direct a request for such
copies to Access Pharmaceuticals, Inc., 2600 Stemmons Freeway,following address: Investor Relations, PlasmaTech Biopharmaceuticals, 4848 Lemmon Avenue, Suite 176,517, Dallas, Texas 75207, attention Chief Financial Officer. You75219, telephone (214) 905-5100.
The validity of the securities being offered hereby will be passed upon by Morgan, Lewis & Bockius LLP. One or more partners or other employees of Morgan, Lewis & Bockius LLP may direct telephone requests to the Chief Financial Officer at (214) 905-5100.
CERTAIN INFORMATION WE ARE INCORPORATING BY REFERENCE
We incorporatebeneficially own shares of our common stock.
The consolidated financial statements incorporated by reference from the documents listed below (SEC File
Number 001-15771) and any future filings we make with the SEC under
Section 13(a), 13(c), 14 or 15(d) of the Securities and Exchange Act of
1934:
* OurCompany’s Annual Report on Form 10-K for the fiscal year ended December 31, 2003;
* Our Quarterly Report on Form 10-Q/A for the quarter ended September
30, 2003; and
* The description of the common stock contained2014, have been audited by Whitley Penn LLP, an independent registered public accounting firm, as stated in our Registration
Statement (No. 333-95413) filed with the SEC under Section 12(d) of the
Securities Exchange Act including any amendment ortheir report, filed for the
purpose of updating such description.
You may request a copy of these filings at no cost, by writing,
telephoning or e-mailing us at the following address:
Access Pharmaceuticals, Inc.
2600 Stemmons Freeway, Suite 176
Dallas, Texas 75207
Attention: Chief Financial Officer
(214) 905-5100
email: akc@accesspharma.com
This prospectus which is part of a Registration Statement we filed with the SEC.
You should rely only on the information incorporated by reference or
provided in this prospectus. No one else is authorized to provide you with
different information. We are not making an offerSuch financial statements have been so incorporated in reliance upon the report of these securitiessuch firm given upon their authority as experts in any state where the offer is not permitted. You should not assume that the
information in this prospectus is accurate as of any date other than the
date on the front of this document.
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We have not authorized any dealer, salesperson or other person to give
any information or to make any representations not contained in this
prospectus or any prospectus supplement. You must not rely on any
unauthorized information. Neither this prospectus nor any prospectus
supplement is an offer to sell or a solicitation of an offer to buy any of
these securities in any jurisdiction where an offer or solicitation is not
permitted. No sale made pursuant to this prospectus shall, under any
circumstances, create any implication that there has not been any change
in the affairs of Access since the date of this prospectus.
------------------------
TABLE OF CONTENTS
Page
------
Access Pharmaceuticals, Inc. 2
Risk Factors 2
Forward Looking Statements 11
Use of Proceeds 12
Selling Stockholders 12
Plan of Distribution 13
Legal Matters 15
Experts 15
Where You Can Get More Information 15
Certain Information We Are Incorporating
By Reference 16
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2,393,196
[LOGO]
Access Pharmaceuticals, Inc.
COMMON STOCK
-----------------
PROSPECTUS
-----------------
March __, 2004
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PART II
INFORMATION NOT REQUIRED IN THE PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
Estimated
Set forth below is an estimate (except in the case of the registration fee) of the amount of fees and expenses (otherto be incurred in connection with the issuance and distribution of the offered securities registered hereby, other than underwriting discounts and commissions)
payablecommission, if any, incurred in connection with the sale of our common stockthe offered hereby
are as follows:
SEC registration fee $ 1,631
Printing and engraving expenses 0
Legal fees and expenses 10,000
Accounting fees and expenses 5,000
Blue Sky fees and expenses (including legal fees) 0
Transfer agent and registrar fees and expenses 0
Miscellaneous 369
---------
Total $ 17,000
=========
securities. All such amounts will be borne by PlasmaTech Biopharmaceuticals, Inc.
| SEC Registration Fee | $ | 1,635 | ||
| Accounting Fees and Expenses | $ | 25,000 | ||
| Legal Fees and Expenses | $ | 25,000 | ||
| Miscellaneous Fees and Expenses | $ | 1,365 | ||
| Total: | $ | 53,000 |
Item 15. Indemnification of Directors and OfficersOfficers.
Section 145 of the Delaware General Corporation law empowers a Delaware corporation to indemnify its officers and directors and certain other persons to the extent and under the circumstances set forth therein.
Our Certificate of Incorporation, as amended, and By-laws, as amended, provide for indemnification of our officers and directors and certain other persons against liabilities and expenses incurred by any of them in certain stated proceedings and under certain stated conditions.
The above discussion of the Registrant’s Certificate of Incorporation, as amended, By-laws, as amended, and Section 145 of the Delaware General Corporation Law (the "DGCL")
empowers a Delaware corporation to indemnify any person who was or
is or is threatenednot intended to be made, a party to any threatened, pending or
completed action, suit or proceeding, whether civil, criminal,
administrative or investigative (other than an action by or in the right of
such corporation) by reason of the fact that such personexhaustive and is or was a
director, officer, employee or agent of such corporation, or is or was
serving at the request of such corporation as a director, officer, employee
or agent of another corporation, partnership, joint venture, trust or other
enterprise, provided that such person acted in good faith and in a manner
that such person reasonably believed to be in or not opposed to the best
interests of the corporation, and, with respect to any criminal action or
proceeding, such person had no reasonable cause to believe his conduct
was unlawful. The indemnity may include expenses (including attorneys'
fees), judgments, fines and amounts paid in settlement actually and
reasonably incurred by such person in connection with such action, suit
or proceeding. A Delaware corporation may also indemnify such persons
against expenses (including attorneys' fees) in actions brought by or in the
right of the corporation to procure a judgmentqualified in its favor, subject to the
same conditions set forth in the immediately preceding sentences, except
that no indemnification is permitted in respect of any claim, issue or
matter as to which such person shall have been adjudged to be liable to
the corporation unless and to the extent the Court of Chancery of the State
of Delaware or the court in which such action or suit was brought shall
determine upon application that, in view of all the circumstances of the
case, such person is fairly and reasonably entitled to indemnity for such
expenses as the Court of Chancery or other such court shall deem proper.
To the extent such person has been successful on the merits or otherwise
in defense of any action to above, or in defense of any claim, issue or
matter therein, the corporation must indemnify such person against
expenses (including attorneys' fees) actually and reasonably incurredentirety by such person in connection therewith. The indemnification and
advancement of expenses provided for in, or granted pursuant to, Section
145 is not exclusive of any other rights to which those seeking
indemnification or advancement of expenses may be entitled under any by-
law, agreement, vote of stockholders or disinterested directors or
otherwise.
Section 145 of the DGCL also provides that a corporation may maintain
insurance against liabilities for which indemnification is not expressly
provided by the statute. The Registrant is insured against liabilities which
it may incur by reason of its indemnification obligations under its Certificate of Incorporation, BylawsBy-Laws and indemnification agreements.
Article Xstatute.
The Company maintains a general liability insurance policy that covers certain liabilities of the Registrant's CertificateCompany’s directors and officers arising out of Incorporation provides that the
Registrant will indemnify, defend and hold harmless directors, officers,
employees and agents or the Registrant to the fullest extent currently
permitted under the DGCL.
In addition, Article X of the Registrant's Certificate of Incorporation,
provides that neither the Registrant nor its stockholders may recover
monetary damages from the Registrant's directors for a breach of their
fiduciary duty in the performance of their duties as directors of the
Registrant, unless such breach relates to (i) the director's duty of loyalty,
(ii)claims based on acts or omissions not in good faiththeir capacities as directors or which involve intentional
misconduct or a knowing violation of law, (iii) unlawful payments of
dividends or unlawful stock repurchases or redemptions as provided in
Section 174 of the DGCL or (iv) any transactions for which the director
derived an improper personal benefit. The By-Laws of the Registrant
provide for indemnification of the Registrant's directors, officers,
employees and agents on the terms permitted under Section 145 of the
DGCL described above.
The Registrant has entered into indemnification agreements with certain
of its directors and executive officers. These agreements provide rights
of indemnification to the full extent allowed and provided for by Section
145 of the DGCL and the Certificate of Incorporation and Bylaws of
Access.
Item 16. Exhibits
Exhibit Index
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Exhibit Number Description
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2.1 Amended and Restated Agreement of Merger and Plan of
Reorganization between Access Pharmaceuticals, Inc. and Chemex
Pharmaceuticals, Inc., dated as of October 31, 1995 (Incorporated by
reference to Exhibit A of the our Registration Statement on Form S-4
dated December 21, 1995, Commission File No. 33-64031)
4.1 Certificate of Incorporation (Incorporated by Reference to Exhibit 3(a)
of our Form 8-B dated July 12, 1989, Commission File Number 9-9134)
4.2 Certificate of Amendment of Certificate of Incorporation filed August
21, 1992
4.3 Certificate of Merger filed January 25, 1996. (Incorporated by
reference to Exhibit E of our Registration Statement on Form S-4 dated
December 21, 1995, Commission File No. 33-64031)
4.4 Certificate of Amendment of Certificate of Incorporation filed January
25, 1996. (Incorporated by reference to Exhibit E of our Registration
Statement on Form S-4 dated December 21, 1995, Commission File No.
33-64031)
4.5 Amended and Restated Bylaws (Incorporated by reference to Exhibit
3.1 of our Form 10-Q for the quarter ended June 30, 1996)
4.6 Certificate of Amendment of Certificate of Incorporation filed July 18,
1996. (Incorporated by reference to Exhibit 3.8 of our Form 10-K for the
year ended December 31, 1996)
4.7 Certificate of Amendment of Certificate of Incorporation filed June
18, 1998. (Incorporated by reference to Exhibit 3.8 of our Form 10-Q for
the quarter ended June 30, 1998)
4.8 Certificate of Amendment of Certificate of Incorporation filed July 31,
2000. (Incorporated by reference to Exhibit 3.8 of our Form 10-Q for the
quarter ended March 31, 2001)
4.9 Certificate of Designations of Series A Junior Participating Preferred
Stock filed November 7, 2001 (Incorporated by reference to Exhibit 4.1.h
of our Registration Statement on Form S-8, dated December 14, 2001,
Commission File No. 333-75136)
5 Opinion of Bingham McCutchen LLP
23.1 Consent of Bingham McCutchen, LLP (included in Exhibit 5)
23.2 Consent of Grant Thornton
INDEX TO EXHIBITS
| 2.1 | Amended and Restated Agreement of Merger and Plan of Reorganization between the Registrant and Chemex Pharmaceuticals, Inc., dated as of October 31, 1995 (Incorporated by reference to Exhibit A of our Registration Statement on Form S-4 dated December 20, 1995, Commission File No. 33-64031) | |
| 2.2 | Agreement and Plan of Merger, by and among the Registrant, Somanta Acquisition Corporation, Somanta Pharmaceuticals, Inc., Somanta Incorporated and Somanta Limited, dated April 19, 2007 (Incorporated by reference to Exhibit 2.1 to our Form 8-K dated April 18, 2007) | |
| 2.3 | Agreement and Plan of Merger, by and among the Registrant, MACM Acquisition Corporation and MacroChem Corporation, dated July 9, 2008 (Incorporated by reference to Exhibit 2.3 of our Form 10-Q for the quarter ended June 30, 2008) | |
| 3.1 | Certificate of Incorporation (Incorporated by reference to Exhibit 3(a) of our Form 8-K dated July 12, 1989, Commission File Number 9-9134) | |
| 3.2 | Certificate of Amendment of Certificate of Incorporation filed August 13, 1992 (Incorporated by reference to Exhibit 3.3 of our Form 10-K for year ended December 31, 1995) | |
| 3.3 | Certificate of Merger filed January 25, 1996 (Incorporated by reference to Exhibit E of our Registration Statement on Form S-4 dated December 20, 1995, Commission File No. 33-64031) |
| 3.4 | Certificate of Amendment of Certificate of Incorporation filed January 25, 1996 (Incorporated by reference to Exhibit E of our Registration Statement on Form S-4 dated December 20, 1995, Commission File No. 33-64031) | |
| 3.5 | Certificate of Amendment of Certificate of Incorporation filed July 18, 1996 (Incorporated by reference to Exhibit 3.7 of our Form 10-K for the year ended December 31, 1996) | |
| 3.6 | Certificate of Amendment of Certificate of Incorporation filed June 18, 1998. (Incorporated by reference to Exhibit 3.8 of our Form 10-Q for the quarter ended June 30, 1998) | |
| 3.7 | Certificate of Amendment of Certificate of Incorporation filed July 31, 2000 (Incorporated by reference to Exhibit 3.8 of our Form 10-Q for the quarter ended March 31, 2001) | |
| 3.8 | Certificate of Designations of Series A Junior Participating Preferred Stock filed November 7, 2001 (Incorporated by reference to Exhibit 4.1.H of our Registration Statement on Form S-8 dated December 14, 2001, Commission File No. 333-75136) | |
| 3.9 | Amended and Restated Bylaws (Incorporated by reference to Exhibit 2.1 of our Form 10-Q for the quarter ended June 30, 1996) | |
| 3.10 | Certificate of Designation, Rights and Preferences of Series A Cumulative Convertible Preferred Stock filed November 9, 2007 (Incorporated by reference to Exhibit 3.10 to our Form SB-2 filed on December 10, 2007) | |
| 3.11 | Certificate of Amendment to Certificate of Designations, Rights and Preferences of Series A Cumulative Convertible Preferred Stock filed June 11, 2008 (Incorporated by reference to Exhibit 3.11 of our Form 10-Q for the quarter ended June 30, 2008) | |
| 3.12 | Certificate of Designations, Rights and Preferences of Series B Cumulative Convertible Preferred Stock filed October 26, 2012 (Incorporated by reference to Exhibit 10.3 of our Form 8-K filed October 26, 2012) | |
| 3.13 | Certificate of Amendment of Certificate of Incorporation filed July 1, 2013 increasing the aggregate number of shares of Common Stock which we have authority to issue to Two Hundred Million (200,000,000) shares with a par value of one cent ($0.01) per share (Incorporated by reference to Exhibit 3.3 of our Form 10-Q for the quarter ended June 30, 2014). | |
| 3.14 | Certificate of Amendment of Certificate of Incorporation filed October 23, 2014 (Incorporated by reference to Exhibit 3.14 of our Form 8-K filed October 23, 2014) | |
| 3.15 | Certificate of Amendment to Certificate of Designations, Rights and Preferences of Series A Cumulative Convertible Preferred Stock (Incorporated by reference to Exhibit 3.15 of our Form 8-K filed on October 23, 2014) | |
| 3.16 | Amendment to Bylaws (Incorporated by reference to Exhibit 3.1 of our Form 8-K filed January 1, 2015) | |
| 3.17 | Amendment to Bylaws (Incorporated by reference to Exhibit 3.1 of our Form 8-K filed March 2, 2015) | |
| 4.1 | Form of stock certificate evidencing shares of common stock, $0.01 par value per share, of the Company (filed herewith) | |
| 4.2 | Form of Warrant dated February 16, 2006, issued by the Company to certain Purchasers (Incorporated by reference to Exhibit 10.31 of the Company’s Form 10-Q for the quarter ended March 31, 2006) | |
| 4.3 | Form of Warrant dated October 24, 2006, issued by the Company to certain Purchasers (Incorporated by reference to Exhibit 10.27 of the Company’s Form 10-KSB filed on April 2, 2007) | |
| 4.4 | Form of Warrant December 6, 2006, issued by the Company to certain Purchasers (Incorporated by reference to Exhibit 10.32 of the Company’s Form 10-KSB filed on April 2, 2007) | |
| 4.5 | Board Designation Agreement dated November 15, 2007, between the Company and SCO Capital Partners LLC (Incorporated by reference to Exhibit 10.26 of the Company’s Form S-1 filed on March 11, 2008) |
| 4.6 | Form of Securities Purchase Agreement (Incorporated by reference to Exhibit 10.29 of the Company’s Form S-1 filed on January 15, 2010) | |
| 4.7 | Form of Warrant (Incorporated by reference to Exhibit 10.30 of the Company’s Form S-1 filed on January 15, 2010) | |
| 4.8 | Form of Securities Purchase Agreement dated as of December 10, 2010 by and among the Company and the Purchasers named therein (Incorporated by reference to Exhibit 10.1 of the Company’s Form 8-K filed on December 14, 2010) | |
| 4.9 | Form of Common Stock Warrant issued by the Company (Incorporated by reference to Exhibit 10.1 of the Company’s Form 8-K filed on December 14, 2010) | |
| 4.10 | Form of Securities Purchase Agreement dated as of November 1, 2011 by and among the Company and the Purchasers named therein (Incorporated by reference to Exhibit 10.1 of the Company’s Form 8-K filed on November 10, 2011) | |
| 4.11 | Form of Common Stock Warrant (Five Year Warrant) issued by the Company (Incorporated by reference to Exhibit 10.3 of the Company’s Form 8-K filed on November 10, 2011) | |
| 4.12 | Amendment No.1 to Warrant Agreement dated February 10, 2012 by and among the Company and warrant holders including certain affiliates named therein extending the term of certain warrants until 2015 (Incorporated by reference to Exhibit 99.1 of the Company’s Form 8-K filed on February 10, 2012) | |
| 4.13 | Preferred Stock and Warrant Purchase Agreement dated October 25, 2012 by and among the Company and the Purchasers named therein (Incorporated by reference to Exhibit 10.1 of the Company’s Form 8-K filed October 26, 2012) | |
| 4.14 | Investor Rights Agreement dated October 25, 2012, between the Company and certain Purchasers (Incorporated by reference to Exhibit 10.2 of the Company’s Form 8-K filed on October 26, 2012) | |
| 4.15 | Form of Common Stock Warrant issued by the Company (Incorporated by reference to Exhibit 10.3 of the Company’s Form 8-K filed on October 26, 2012) | |
| 4.16 | Unsecured Grid Note $250,000, dated September 10, 2014, by and between the Company and SCO Capital Partners LLC (Incorporated by reference to Exhibit 10.33 of the Company’s Form 8-K filed October 23, 2014) | |
| 4.17 | Unsecured Grid Note $250,000, dated December 1, 2014, by and between us and SCO Capital Partners LLC (Incorporated by reference to Exhibit 10.34 of our Form 8-K filed December 3, 2014) | |
| 4.18 | Form of Warrant Agreement between the Company and American Stock Transfer & Trust Company (Incorporated by reference to Exhibit 4.1 of the Company’s Pre-effective Amendment No. 1 to Form S-1 filed October 24, 2014) | |
| 5.1 | Opinion of Morgan, Lewis & Bockius LLP (filed herewith) | |
| 23.1 | Consent of Whitley Penn LLP (filed herewith) | |
| 23.2 | Consent of Morgan, Lewis & Bockius LLP (included in Exhibit 5.1) | |
| 24 | Powers of Attorney (included on signature page) |
Item 17. Undertakings.
(a) The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, pursuant to this Registration Statement, a post-effective amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act.
(ii) To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Statement toFee” table in the effective registration statement.
(iii) To include any material information with respect to the plan of distribution not this Registration Statementthe registration statement or any material change to such information in this Registration Statement;
the registration statement.
provided, however, that paragraphs (i), (ii) and (iii) do not apply if the registration statement is on Form S-3 and the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the registrant pursuant to Section 13 or Section 15(d) of the Exchange Act that are incorporated by reference in the registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement;
(2) That, for the purpose of determining any liability under the Securities Act, of 1933, each such post-effective amendment shall be deemed to be a new Registration Statementregistration 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.
(3) To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
(5) That, for the purpose of determining liability under the Securities Act to any purchaser:
(i) each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and
(ii) each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5) or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii) or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which the prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof;provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date; and
(6) That, for the purpose of determining liability of the registrant under the Securities Act to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:
(i) any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424;
(ii) any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;
(iii) the portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and
(iv) any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.
(b) The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act, of 1933, each filing of the registrant'sregistrant’s annual report pursuant to Section 13(a) or 15(d) of the
Securities Exchange Act of 1934 (and, where applicable, each filing of an
employee benefit plan's annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in thethis registration statement 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.
(h) Insofar as indemnification for liabilities arising under the Securities Act
of 1933 may be permitted to directors, officers and controlling persons of the Registrantregistrant pursuant to the foregoing provisions described inunder Item 15 above, or otherwise, the Registrantregistrant has 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 the Registrantregistrant of expenses incurred or paid by a director, officer or controlling person of the Registrantregistrant 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, the Registrantregistrant 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.
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrantregistrant, PlasmaTech Biopharmaceuticals, Inc., certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Dallas, State of Texas, on this 24th14th day of March, 2004.
ACCESS PHARMACEUTICALS, INC.
By /s/ Kerry P. Gray
-----------------------
Kerry P. Gray
President and Chief Executive Officer, Director
May, 2015.
| PLASMATECH BIOPHARMACEUTICALS, INC. | ||
| By: | /s/Steven H. Rouhandeh | |
| Steven H. Rouhandeh | ||
| Executive Chairman | ||
| By: | /s/Stephen B. Thompson | |
| Stephen B. Thompson | ||
| Vice President Finance | ||
POWER OF ATTORNEY AND SIGNATURES
Each
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints Kerry P. Gray,Steven H. RouhandehandJeffrey B. Davis, and each of them, as his attorney-in-factsuch person’s true and agent,lawful attorneys-in-fact and agents with full power of substitution and resubstitution, for himsuch person and in hissuch person’s name, place and stead, in any and all capacities, (i) to sign any and all amendments (including post-effective amendments) and additions to this Registration Statement (ii)on Form S-3 and to sign any registration statement to be filed pursuant to Rule 462(b) under
the Securities Act of 1933 for the purpose of registering additional shares
of Common Stock for the same offering covered by this Registration
Statement, and (iii) to file any of the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto saidand hereby grants to such attorneys-in-fact and agents and each of
them, full power and authority to do and perform each and every act and thing requisite and necessary to be done, in and about the premises, as fully to all intents and purposes as hesuch person might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents or any
of them, or their or hissuch person’s substitute or substitutes may lawfully do or cause to be done by virtue thereof.
hereof.
Pursuant to the requirements of the Securities Act of 1933, thethis Registration Statement has been signed by the following personpersons in the capacities and onindicated as of the dates indicated.
Signature Title Date
- --------------------------- ----------------------------- ---------------
/s/ Kerry P. Gray
- ------------------------
Kerry P. Gray President and Chief Executive
Officer, Director March 24, 2004
/s/ Stuart M. Duty
- ---------------------
Stuart M. Duty Director March 24, 2004
/s/ Herbert H. McDade, Jr.
- ---------------------------
Herbert H. McDade, Jr. Director March 24, 2004
/s/ J. Michael Flinn
- ---------------------------
J. Michael Flinn Director March 24, 2004
/s/ Stephen B. Howell
- ------------------------
Stephen B. Howell Director March 24, 2004
/s/ Max Link
- ------------------
Max Link Director March 24, 2004
/s/ John J. Meakem, Jr.
- ------------------------
John J. Meakem, Jr. Director March 24, 2004
/s/ Stephen B. Thompson
- -------------------------
Stephen B. Thompson Vice President, Chief Financial
Officer, Treasurer March 24, 2004
14th day of May, 2015.
| Signature | Capacity | Date | ||
Executive Chairman and | ||||
| /s/Steven H. Rouhandeh | Chairman of the Board | May 14, 2015 | ||
| Steven H. Rouhandeh | (principal executive officer) | |||
| /s/Stephen B. Thompson | Vice President Finance | May 14, 2015 | ||
| Stephen B. Thompson | (principal financial and accounting officer) | |||
| /s/Jeffrey B. Davis | Director | May 14, 2015 | ||
| Jeffrey B. Davis | ||||
| /s/Mark J. Ahn | Director | May 14, 2015 | ||
| Mark J. Ahn | ||||
| /s/Mark J. Alvino | Director | May 14, 2015 | ||
| Mark J. Alvino | ||||
| /s/Stephen B. Howell | Director | May 14, 2015 | ||
| Stephen B. Howell | ||||
| /s/Todd Wider | Director | May 14, 2015 | ||
| Todd Wider |
EXHIBITS
| 2.1 | Amended and Restated Agreement of Merger and Plan of Reorganization between the Registrant and Chemex Pharmaceuticals, Inc., dated as of October 31, 1995 (Incorporated by reference to Exhibit A of our Registration Statement on Form S-4 dated December 20, 1995, Commission File No. 33-64031) | |
| 2.2 | Agreement and Plan of Merger, by and among the Registrant, Somanta Acquisition Corporation, Somanta Pharmaceuticals, Inc., Somanta Incorporated and Somanta Limited, dated April 19, 2007 (Incorporated by reference to Exhibit 2.1 to our Form 8-K dated April 18, 2007) | |
| 2.3 | Agreement and Plan of Merger, by and among the Registrant, MACM Acquisition Corporation and MacroChem Corporation, dated July 9, 2008 (Incorporated by reference to Exhibit 2.3 of our Form 10-Q for the quarter ended June 30, 2008) | |
| 3.1 | Certificate of Incorporation (Incorporated by reference to Exhibit 3(a) of our Form 8-K dated July 12, 1989, Commission File Number 9-9134) | |
| 3.2 | Certificate of Amendment of Certificate of Incorporation filed August 13, 1992 (Incorporated by reference to Exhibit 3.3 of our Form 10-K for year ended December 31, 1995) | |
| 3.3 | Certificate of Merger filed January 25, 1996 (Incorporated by reference to Exhibit E of our Registration Statement on Form S-4 dated December 20, 1995, Commission File No. 33-64031) | |
| 3.4 | Certificate of Amendment of Certificate of Incorporation filed January 25, 1996 (Incorporated by reference to Exhibit E of our Registration Statement on Form S-4 dated December 20, 1995, Commission File No. 33-64031) | |
| 3.5 | Certificate of Amendment of Certificate of Incorporation filed July 18, 1996 (Incorporated by reference to Exhibit 3.7 of our Form 10-K for the year ended December 31, 1996) | |
| 3.6 | Certificate of Amendment of Certificate of Incorporation filed June 18, 1998. (Incorporated by reference to Exhibit 3.8 of our Form 10-Q for the quarter ended June 30, 1998) | |
| 3.7 | Certificate of Amendment of Certificate of Incorporation filed July 31, 2000 (Incorporated by reference to Exhibit 3.8 of our Form 10-Q for the quarter ended March 31, 2001) | |
| 3.8 | Certificate of Designations of Series A Junior Participating Preferred Stock filed November 7, 2001 (Incorporated by reference to Exhibit 4.1.H of our Registration Statement on Form S-8 dated December 14, 2001, Commission File No. 333-75136) | |
| 3.9 | Amended and Restated Bylaws (Incorporated by reference to Exhibit 2.1 of our Form 10-Q for the quarter ended June 30, 1996) | |
| 3.10 | Certificate of Designation, Rights and Preferences of Series A Cumulative Convertible Preferred Stock filed November 9, 2007 (Incorporated by reference to Exhibit 3.10 to our Form SB-2 filed on December 10, 2007) | |
| 3.11 | Certificate of Amendment to Certificate of Designations, Rights and Preferences of Series A Cumulative Convertible Preferred Stock filed June 11, 2008 (Incorporated by reference to Exhibit 3.11 of our Form 10-Q for the quarter ended June 30, 2008) | |
| 3.12 | Certificate of Designations, Rights and Preferences of Series B Cumulative Convertible Preferred Stock filed October 26, 2012 (Incorporated by reference to Exhibit 10.3 of our Form 8-K filed October 26, 2012) | |
| 3.13 | Certificate of Amendment of Certificate of Incorporation filed July 1, 2013 increasing the aggregate number of shares of Common Stock which we have authority to issue to Two Hundred Million (200,000,000) shares with a par value of one cent ($0.01) per share (Incorporated by reference to Exhibit 3.3 of our Form 10-Q for the quarter ended June 30, 2014). | |
| 3.14 | Certificate of Amendment of Certificate of Incorporation filed October 23, 2014 (Incorporated by reference to Exhibit 3.14 of our Form 8-K filed October 23, 2014) |
| 3.15 | Certificate of Amendment to Certificate of Designations, Rights and Preferences of Series A Cumulative Convertible Preferred Stock (Incorporated by reference to Exhibit 3.15 of our Form 8-K filed on October 23, 2014) | |
| 3.16 | Amendment to Bylaws (Incorporated by reference to Exhibit 3.1 of our Form 8-K filed January 1, 2015) | |
| 3.17 | Amendment to Bylaws (Incorporated by reference to Exhibit 3.1 of our Form 8-K filed March 2, 2015) | |
| 4.1 | Form of stock certificate evidencing shares of common stock, $0.01 par value per share, of the Company (filed herewith) | |
| 4.2 | Form of Warrant dated February 16, 2006, issued by the Company to certain Purchasers (Incorporated by reference to Exhibit 10.31 of the Company’s Form 10-Q for the quarter ended March 31, 2006) | |
| 4.3 | Form of Warrant dated October 24, 2006, issued by the Company to certain Purchasers (Incorporated by reference to Exhibit 10.27 of the Company’s Form 10-KSB filed on April 2, 2007) | |
| 4.4 | Form of Warrant December 6, 2006, issued by the Company to certain Purchasers (Incorporated by reference to Exhibit 10.32 of the Company’s Form 10-KSB filed on April 2, 2007) | |
| 4.5 | Board Designation Agreement dated November 15, 2007, between the Company and SCO Capital Partners LLC (Incorporated by reference to Exhibit 10.26 of the Company’s Form S-1 filed on March 11, 2008) | |
| 4.6 | Form of Securities Purchase Agreement (Incorporated by reference to Exhibit 10.29 of the Company’s Form S-1 filed on January 15, 2010) | |
| 4.7 | Form of Warrant (Incorporated by reference to Exhibit 10.30 of the Company’s Form S-1 filed on January 15, 2010) | |
| 4.8 | Form of Securities Purchase Agreement dated as of December 10, 2010 by and among the Company and the Purchasers named therein (Incorporated by reference to Exhibit 10.1 of the Company’s Form 8-K filed on December 14, 2010) | |
| 4.9 | Form of Common Stock Warrant issued by the Company (Incorporated by reference to Exhibit 10.1 of the Company’s Form 8-K filed on December 14, 2010) | |
| 4.10 | Form of Securities Purchase Agreement dated as of November 1, 2011 by and among the Company and the Purchasers named therein (Incorporated by reference to Exhibit 10.1 of the Company’s Form 8-K filed on November 10, 2011) | |
| 4.11 | Form of Common Stock Warrant (Five Year Warrant) issued by the Company (Incorporated by reference to Exhibit 10.3 of the Company’s Form 8-K filed on November 10, 2011) | |
| 4.12 | Amendment No.1 to Warrant Agreement dated February 10, 2012 by and among the Company and warrant holders including certain affiliates named therein extending the term of certain warrants until 2015 (Incorporated by reference to Exhibit 99.1 of the Company’s Form 8-K filed on February 10, 2012) | |
| 4.13 | Preferred Stock and Warrant Purchase Agreement dated October 25, 2012 by and among the Company and the Purchasers named therein (Incorporated by reference to Exhibit 10.1 of the Company’s Form 8-K filed October 26, 2012) | |
| 4.14 | Investor Rights Agreement dated October 25, 2012, between the Company and certain Purchasers (Incorporated by reference to Exhibit 10.2 of the Company’s Form 8-K filed on October 26, 2012) | |
| 4.15 | Form of Common Stock Warrant issued by the Company (Incorporated by reference to Exhibit 10.3 of the Company’s Form 8-K filed on October 26, 2012) | |
| 4.16 | Unsecured Grid Note $250,000, dated September 10, 2014, by and between the Company and SCO Capital Partners LLC (Incorporated by reference to Exhibit 10.33 of the Company’s Form 8-K filed October 23, 2014) | |
| 4.17 | Unsecured Grid Note $250,000, dated December 1, 2014, by and between us and SCO Capital Partners LLC (Incorporated by reference to Exhibit 10.34 of our Form 8-K filed December 3, 2014) |
| 4.18 | Form of Warrant Agreement between the Company and American Stock Transfer & Trust Company (Incorporated by reference to Exhibit 4.1 of the Company’s Pre-effective Amendment No. 1 to Form S-1 filed October 24, 2014) | |
| 5.1 | Opinion of Morgan, Lewis & Bockius LLP (filed herewith) | |
| 23.1 | Consent of Whitley Penn LLP (filed herewith) | |
| 23.2 | Consent of Morgan, Lewis & Bockius LLP (included in Exhibit 5.1) | |
| 24 | Powers of Attorney (included on signature page) |
| 20 |