UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

 

xQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended SeptemberJune 30, 20162017

 

OR

 

¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from _______ to _______

 

Commission file number: 001-35610

 

ATOSSA GENETICS INC.

(Exact name of registrant as specified in its charter)

 

Delaware 26-4753208
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
   
107 Spring Street 98104
Seattle, WA (Zip Code)
(Address of principal executive offices) 

 

Registrant’s telephone number, including area code: (206) 325-6086

 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yesþ     No¨

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

Yesþ     No¨

 

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 definition of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer  ¨Accelerated filer  ¨Non-accelerated filer  ¨Smaller reporting company  þ

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes¨ Noþ ☒

 

The number of shares of the registrant’s common stock, $0.015 par value per share, outstanding at November 11, 2016August 14, 2017 was 3,787,967.11,701,075.

 

 

 

  

ATOSSA GENETICS INC.

FORM 10-Q

QUARTERLY REPORT

 

INDEX

 

PART I. FINANCIAL INFORMATION3
   
ITEM 1.Condensed Consolidated Financial Statements – Unaudited3
   
 Condensed Consolidated Balance Sheets as of SeptemberJune 30, 20162017 and December 31, 201520163
   
 Condensed Consolidated Statements of Operations for the three and ninesix months ended SeptemberJune 30, 20162017 and 201520164
   
 Condensed Consolidated Statement of Stockholders’ Equity for the ninesix months ended SeptemberJune 30, 201620175
   
 Condensed Consolidated Statements of Cash Flows for the ninesix months ended SeptemberJune 30, 20162017 and 201520166
   
 Notes to Consolidated Financial Statements7
   
ITEM 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations1719
   
ITEM 3Quantitative and Qualitative Disclosures about Market Risk2526
   
ITEM 4.Controls and Procedures2526
   
PART II. OTHER INFORMATION2526
   
ITEM 1.Legal Proceedings25
ITEM 1A.Risk Factors26
   
ITEM 1A.Risk Factors27
ITEM 2.Unregistered Sales of Equity Securities and Use of Proceeds26
ITEM 3.Defaults upon Senior Securities27
   
ITEM 4.3.Mine Safety DisclosuresDefaults upon Senior Securities2728
   
ITEM 5.4.Other InformationMine Safety Disclosures2728
   
ITEM 5.Other Information28
ITEM 6.Exhibits2728
   
SIGNATURES2829

 

2 

 

  

PART I. FINANCIAL INFORMATION

 

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

ATOSSA GENETICS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

  June 30,  December 31, 
  2017  2016 
Assets        
Current assets        
Cash and cash equivalents $3,690,023  $3,027,962 
Restricted cash  55,000   55,000 
Prepaid expenses  228,370   171,601 
Other accounts receivable  2,736     
Total current assets  3,976,129   3,254,563 
         
Furniture and equipment, net  18,989   55,119 
Intangible assets, net  585,683   640,440 
Other assets  128,577   194,250 
Total assets $4,709,378  $4,144,372 
         
Liabilities and Stockholders’ Equity        
         
Current liabilities        
Accounts payable $495,811  $254,320 
Accrued expenses  44,017   16,964 
Payroll liabilities  482,420   769,899 
Common stock warrant liability  864,371     
Other current liabilities  19,157   6,083 
Total current liabilities  1,905,776   1,047,266 
         
Commitments and contingencies (note 13)        
         
Stockholders’ equity        
Preferred stock - $.001 par value; 10,000,000 shares authorized, consisting of:        
Series A convertible preferred stock- $.001 par value; 4,000 and 0 shares authorized, and 839 and 0 shares issued and outstanding, as of June 30, 2017 and December 31, 2016, respectively  1     
Additional paid in capital- Series A convertible preferred stock  774,977     
Common stock - $.015 par value; 75,000,000 shares authorized, 10,032,410 and 3,786,913 shares issued and outstanding, as of June 30, 2017 and December 31, 2016, respectively  150,486   56,804 
Additional paid-in capital  63,126,929   60,344,050 
Accumulated deficit  (61,248,791)  (57,303,748)
Total stockholders’ equity  2,803,602   3,097,106 
         
Total liabilities and stockholders’ equity $4,709,378  $4,144,372 

 

  September 30,  December 31, 
  2016  2015 
  (Unaudited)    
Assets        
Current assets        
Cash and cash equivalents $4,388,177  $3,715,895 
Restricted cash  55,000   275,000 
Prepaid expense  120,751   193,293 
Other current assets  -   110,663 
Total current assets  4,563,928   4,294,851 
         
Furniture and equipment, net  84,537   171,568 
Intangible assets, net  1,401,899   1,700,565 
Other assets  227,877   76,337 
Total assets $6,278,241  $6,243,321 
         
Liabilities and Stockholders’ Equity        
         
Current liabilities        
Accounts payable $197,354  $814,448 
Accrued expenses  12,480   463,676 
Payroll liabilities  635,047   1,159,335 
Other current liabilities  18,886   64,128 
Total current liabilities  863,767   2,501,587 
         
Commitments and contingencies (note 13)        
         
Stockholders’ equity        
Preferred stock - $.001 par value; 10,000,000 shares authorized, 0 shares issued and outstanding  -   - 
Common stock - $.015 par value; 75,000,000 shares authorized, 3,787,967 and 2,177,151 shares issued and outstanding  56,820   32,657 
Additional paid-in capital  60,137,752   54,643,940 
Accumulated deficit  (54,780,098)  (50,934,863)
Total stockholders’ equity  5,414,474   3,741,734 
         
Total liabilities and stockholders’ equity $6,278,241  $6,243,321 

The accompanying notes are an integral part of these condensed consolidated financial statements

3

ATOSSA GENETICS INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

  For the Three Months Ended
September 30,
  For the Nine Months Ended
September 30,
 
  2016  2015  2016  2015 
Net revenue $-  $-  $-  $- 
Operating expenses:                
Selling  -   498,609   -   1,187,777 
Research and development  85,000   948,961   403,963  1,888,236 
General and administrative  1,473,435   2,395,089   5,040,939  7,208,508 
Total operating expenses  1,558,435  3,842,659   5,444,902  10,284,521 
Operating loss  (1,558,435)  (3,842,659)  (5,444,902)  (10,284,521)
Other income, net  1,763,124   69,350   1,599,667   116,108 
Income (Loss) before income taxes  204,689   (3,773,309)  (3,845,235)  (10,168,413)
Income taxes  -   -   -   - 
    Income (Loss) from continuing operations  204,689   (3,773,309)  (3,845,235)  (10,168,413)
    Loss from discontinued operations  -   (544,802)  -   (630,314)
Net income (loss) $204,689  $(4,318,111) $(3,845,235) $(10,798,727)
Income (Loss) per common share from continuing operations - basic and diluted $0.07  $(2.04) $(1.72) $(5.91)
Loss per common share from discontinued operations – basic and diluted  -  $(0.30)  -  $(0.37)
Weighted average shares outstanding, basic & diluted  2,799,082   1,845,747   2,240,869   1,720,353 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

43 

 

   

ATOSSA GENETICS INC.

CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY

(UNAUDITED)

  Common Stock  Additional
Paid-in
  Accumulated  Total
Stockholders’
 
  Shares  Amount  Capital  Deficit  Equity 
                
Balance at December 31, 2015  2,177,151  $32,657  $54,643,940  $(50,934,863) $3,741,734 
                     
Issuance of common shares and warrants (net of issuance costs of $356,214)  1,561,080   23,417   4,672,452   -   4,695,869 
Issuance of common shares as commitment fees  49,736   746   197,777   -   198,523 
Amortization of commitment shares          (26,470)      (26,470)
Compensation cost for stock options granted to executives and employees  -   -   650,053   -   650,053 
Net loss  -   -   -   (3,845,235)  (3,845,235)
Balance at September 30, 2016  3,787,967  $56,820  $60,137,752  $(54,780,098) $5,414,474 

The accompanying notes are an integral part of these consolidated financial statements.

5

ATOSSA GENETICS INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWSOPERATIONS

(UNAUDITED)

 

  For the Nine Months
Ended September 30,
 
  2016  2015 
CASH FLOWS FROM OPERATING ACTIVITIES        
Net loss $(3,845,235) $(10,798,727)
Net loss from discontinued operations  -   630,314 
Compensation cost for stock options granted  650,053   633,962 

Loss (gain) on disposal of intangible asset

  163,333   (74,800)
Depreciation and amortization  227,387   168,264 
Changes in operating assets and liabilities:        
Change in restricted cash  220,000   (275,000)
Inventory  -   (78,265)
Prepaid expenses  72,542   72,723 
Other assets   131,176   (4,456)
Accounts payable  (617,094)  408,081 
Payroll liabilities  (524,288)  62,772 
Deferred rent  -   11,298 
Accrued expenses  (451,196)  (1,000,662)
Other current liabilities  (45,242)  (27,720)
Net cash used in continuing operating activities  (4,018,564)  (10,272,216)
Net cash provided by discontinued operating activities  -   272,344 
Net cash used in operating activities  (4,018,564)  (9,999,872)
         
CASH FLOWS FROM INVESTING ACTIVITIES        
Purchase of furniture and equipment  (5,023)  (51,395)
Purchase of intangible assets  -   (15,553)
Net cash used in continuing investing activities  (5,023)  (66,948
Net cash used in discontinued investing activities  -   (43,801)
Net cash used in investing activities  (5,023)  (110,749)
         
CASH FLOWS FROM FINANCING ACTIVITIES        
Net proceeds from issuance of common stock and warrants, net of issuance costs of $356,214 and $577,790, respectively  4,695,869   9,498,557 
Payments on capital lease obligations  -   (49,215)
Net cash provided by financing activities  4,695,869   9,449,342 
         
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS  672,282   (661,279)
CASH AND CASH EQUIVALENTS, BEGINNING BALANCE  3,715,895   8,500,718 
CASH AND CASH EQUIVALENTS, ENDING BALANCE $4,388,177  $7,839,439 
         
SUPPLEMENTAL DISCLOSURES:        
Interest paid $1,304  $3,311 
NONCASH INVESTING AND FINANCING ACTIVITIES:        
Common stock issued as commitment fee under stock purchase agreement $198,523  $- 
Amortization of commitment shares $26,470  $392,711 

  For the Three Months Ended
June 30,
  For The Six Months Ended
June 30,
 
       
   2017   2016   2017   2016 
Operating expenses:                
Research and development $824,094  $168,992  $1,368,396  $318,963 
General and administrative  1,072,169   1,553,391   2,214,712   3,730,960 
Total operating expenses  1,896,263   1,722,383   3,583,108   4,049,923 
Operating loss  (1,896,263)  (1,722,383)  (3,583,108)  (4,049,923)
Change in fair value of common stock warrants  (152,447)      (152,447)    
Warrant financing expense  (192,817)      (192,817)    
Other income (expense), net  38       (16,671)    
Loss before income taxes  (2,241,489)  (1,722,383)  (3,945,043)  (4,049,923)
Income taxes                
Net loss $(2,241,489) $(1,722,383) $(3,945,043) $(4,049,923)
Deemed dividends attributable to Series A Preferred Stock  (2,568,132)      (2,568,132)    
Net loss applicable to common stockholders $(4,809,621) $(1,722,383) $(6,513,175) $(4,049,923)
Loss per common share - basic and diluted $(0.64) $(0.67) $(1.15) $(1.63)
Weighted average shares outstanding, basic and diluted  7,476,046   2,587,871   5,641,671   2,485,853 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

64 

 

 

ATOSSA GENETICS, INC.

CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY

(UNAUDITED)

  Series A
Convertible
Preferred Stock
     Common Stock  Additional     Total 
        Additional        Paid-in  Accumulated  Stockholders’ 
  Shares  Amount  Paid-in Capital  Shares  Amount  Capital  Deficit  Equity 
Balance at December 31, 2016    $  $   3,786,913  $56,804  $60,344,050  $(57,303,748) $3,097,106 
                                 
Issuance of common stock in Class A units, net of issuance costs of $65,816              1,194,000   17,910   811,774       829,684 
Allocation of Class A unit proceeds to warrant liability                      (328,350)       (328,350) 
Issuance of Series A convertible preferred stock in Class B units, net of issuance costs of $267,231  3,502   4   3,234,769                   3,234,773 
Allocation of Series A convertible preferred stock to warrants and beneficial conversion feature          (2,568,132)           1,284,066       (1,284,066) 
Deemed Dividends on Series A Convertible Preferred Stock          2,568,132           (2,568,132)        
Conversion of Series A Convertible Preferred  Stock to common stock  (2,663)  (3  (2,459,792)  3,550,664   53,260   2,406,535         
 Reclassification of warrant liability upon net cashless exercise of common stock warrants              1,490,833    22,362    878,126        900,488  
Issuance of common stock upon warrant exercise for cash              10,000   150   2,450       2,600 
                                 
Amortization of commitment shares                      (39,705)      (39,705)
Compensation cost for stock options granted to executives and employees                      336,115       336,115 
Net loss                          (3,945,043)  (3,945,043)
Balance at June 30, 2017  839  $1  $774,977   10,032,410  $150,486  $63,126,929  $(61,248,791) $2,803,602

The accompanying notes are an integral part of these condensed consolidated financial statements.

ATOSSA GENETICS INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

  For the Six Months
Ended June 30,
 
  2017  2016 
CASH FLOWS FROM OPERATING ACTIVITIES        
Net loss $(3,945,043) $(4,049,923)
Compensation cost for stock options granted  336,115   392,664 
Loss on disposal of intangible asset  17,695   163,333 
Depreciation and amortization  73,193   152,574 
Change in fair value of common stock warrants  152,447     
Warrant financing expense  192,817     
Changes in operating assets and liabilities:        
Change in restricted cash      220,000 
Prepaid expenses  (56,769)  (15,836)
Other assets  25,831   110,527 
Accounts payable  241,491   (531,657
Payroll liabilities  (287,479)  (666,368)
Accrued expenses  27,053   (387,903)
Other current liabilities  13,074   (41,473)
  Net cash used in operating activities  (3,209,575)  (4,654,062)
         
CASH FLOWS FROM INVESTING ACTIVITIES        
Purchase of furniture and equipment      (4,941
Net cash used in investing activities      (4,941)
         
CASH FLOWS FROM FINANCING ACTIVITIES        
  Proceeds from issuance of Class A and Class B Units, net of issuance costs  3,871,636     
  Proceeds from issuance of common stock, net of issuance costs      2,133,974 
Net cash provided by financing activities  3,871,636   2,133,974 
         
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS       662,061   (2,525,029
CASH AND CASH EQUIVALENTS, BEGINNING BALANCE  3,027,962   3,715,895 
CASH AND CASH EQUIVALENTS, ENDING BALANCE $3,690,023  $1,190,866 
         
SUPPLEMENTAL DISCLOSURES:        
Interest paid $   $383 
NONCASH INVESTING AND FINANCING ACTIVITIES:        
Common stock issued for cashless exercise of common stock warrants $900,488     
Amount receivable for warrant exercise  2,600     
Allocation of Class A and Class B Unit proceeds to warrant liability  1,612,416     
Common stock issued as commitment fee under stock purchase agreement      198,523 
Amortization of commitment shares $39,705  $6,617 

The accompanying notes are an integral part of these condensed consolidated financial statements.

ATOSSA GENETICS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

NOTE 1: NATURE OF OPERATIONS

 

Atossa Genetics Inc. (the “Company”) was incorporated on April 30, 2009 in the State of Delaware. The Company was formed to develop and market medical devices, laboratory tests and therapeutics to address breast health conditions. The Company’s fiscal year ends on December 31.

In December 2011, the Company established the National Reference Laboratory for Breast Health, Inc., or NRLBH, as a wholly-owned subsidiary. NRLBH was the Company’s CLIA-certified laboratory which performed the Company’s nipple aspirate fluid, or NAF, cytology test on NAF specimens including those collected with the Company’s Mammary Aspiration Specimen Cytology Test (MASCT) System. The current version of the MASCT System is called the ForeCYTE Breast Aspirator. The NRLBH provides other test services, including pharmacogenomics tests. On December 16, 2015, the Company sold approximately 81% of the capital stock of the NRLBH to the NRL Investment Group, LLC, with the Company retaining a 19% ownership through preferred stock. The Company received $50,000 at the time of the sale and the right to receive, commencing December 2016, monthly earn-out payments equal to 6% of gross revenue of NRLBH up to $10,000,000, and the right to sell its preferred stock after four years for the greater of $4,000,000 or fair market value. The Company has elected to recognize any subsequent gain from the earn-out payments as they are determined realizable.

As a result of the sale of the laboratory business, the Company is now focusingfocused on development of its pharmaceutical programs.

 

NOTE 2: GOING CONCERN

 

The Company’s consolidated financial statements are prepared using generally accepted accounting principlesGenerally Accepted Accounting Principles in the United States of America applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred net losses and negative operating cash flows since inception. For the ninesix months ended SeptemberJune 30 2016,2017, the Company recorded a net loss of approximately $3.8$3.9 million and used approximately $4.0$3.2 million of cash in operating activities. As of SeptemberJune 30, 2016,2017, the Company had approximately $4.4$3.7 million in cash and cash equivalents and working capital of approximately $3.7$2.1 million. The Company has not yet established an ongoing source of revenue sufficient to cover its operating costs and allow it to continue as a going concern. The ability of the Company to continue as a going concern is dependent on the Company obtaining adequate capital to fund operating losses until it becomes profitable. The Company can give no assurances that any additional capital that it is able to obtain, if any, will be sufficient to meet its needs, or that any such capital will be obtained on acceptable terms. If the Company is unable to obtain adequate capital, it could be forced to cease operations or substantially curtail its activities. These conditions raise substantial doubt as to the Company’s ability to continue as a going concern. The accompanying consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts and classification of liabilities should the Company be unable to continue as a going concern.

 

Management’s plan to continue as a going concern is as follows. In order to continue as a going concern, the Company will need, among other things, additional capital resources. Management’s plans to obtain such resources for the Company include obtaining capital from the sale of its equity securities and short-term borrowings from banks, stockholders or other related party(ies), if needed. However, management cannot provide any assurance that the Company will be successful in accomplishing any of its plans.

 

We expect that our existing resources will be sufficient to fund our planned operations for the next four to six months; however, additional capital resources will be needed to fund operations for the next twelve months.

The ability of the Company to continue as a going concern is dependent upon its ability to successfully accomplish the plans described in the preceding paragraphparagraphs and eventually to secure other sources of financing and attain profitable operations.

 

7 

 

 

NOTE 3: SUMMARY OF ACCOUNTING POLICIES

 

Basis of Presentation:

 

The accompanying consolidated financial statementsunaudited Condensed Consolidated Financial Statements have been prepared pursuant to the rules of the Securities and Exchange Commission (“SEC”) and in accordance with U.S.accounting principles generally accepted accounting principles (“GAAP”). The accompanying consolidated financial statements include the financial statements of Atossa Genetics Inc. and its formerly wholly-owned subsidiary, NRLBH. The Company sold a majority of its interest in the NRLBH in December 2015United States (GAAP) for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. They do not include all of its activities are reportedinformation and notes required by GAAP for complete financial statements. However, except as discontinued operationsdisclosed herein, there has been no material change in the accompanying consolidated financial statements. All significant intercompany account balances and transactions have been eliminatedinformation disclosed in consolidation.Certain amounts from prior years have been reclassifiedthe Notes to conform withConsolidated Financial Statements included in the 2016 presentation.Annual Report on Form 10-K of the Company for the year ended December 31, 2016.

 

In the opinion of management, all adjustments (including normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three and six months ended June 30, 2017 are not necessarily indicative of the results that may be expected for the year ending December 31, 2017.

On August 26,2016,26, 2016, the Company completed a 1-for-15 reverse stock split of the shares of the Company’s common stock (the “Reverse Stock Split”). As a result of the Reverse Stock Split, every 15 shares of issued and outstanding common stock were combined into one issued and outstanding share of Common Stock, and the par value per share was changed to $.015 per share. No fractional shares were issued because of the Reverse Stock Split and any fractional shares that would otherwise have resulted from the Reverse Stock Split were paid in cash. As a result of the Reverse Stock Split, as of November 11, 2016, there are 3,787,967 shares of common stock outstanding. The number of authorized shares of common stock was not reduced as a result of the Reverse Stock Split. The Company’s common stock began trading on a reverse stock split-adjusted basis on August 26, 2016. All share and per share data included in this report has been retroactively restated to reflect the Reverse Stock Split.

Use of Estimates:

 

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

 

Financial Instruments with Characteristics of Both Liabilities and Equity:

During the three months ended June 30, 2017, the Company issued certain financial instruments, including warrants to purchase common stock, which have characteristics of both liability and equity. Financial instruments such as warrants that are classified as liabilities are fair valued upon issuance and are remeasured at fair value at subsequent reporting periods with the resulting change in fair value recorded in “change in fair value of common stock warrants”. The fair value of warrants is estimated using valuation models that require the input of subjective assumptions including stock price volatility, expected life, and the probability of future equity issuances and their impact to the price protection feature.

Recently Issued Accounting Pronouncements:

 

In May 2014, theFebruary 2016, Financial Accounting Standards Board (the “FASB”(“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09,Revenue from Contracts with Customers: Topic 606 (“ASU 2014-09”), to supersede nearly all existing revenue recognition guidance under U.S. GAAP. The core principle of ASU 2014-09 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration that is expected to be received for those goods or services. ASU 2014-09 defines a five step process to achieve this core principle and, in doing so, it is possible more judgment and estimates may be required within the revenue recognition process than required under existing GAAP including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. ASU 2014-09 is effective for the Company in the first quarter of 2018 using either of two methods: (i) retrospective to each prior reporting period presented with the option to elect certain practical expedients as defined within ASU 2014-09; or (ii) retrospective with the cumulative effect of initially applying ASU 2014-09 recognized at the date of initial application and providing certain additional disclosures as defined per ASU 2014-09. The Company is currently evaluating the impact of its pending adoption of ASU 2014-09 on its consolidated financial statements. 

In August 2014, FASB issued ASU 2014-15,Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. This ASU requires the management to determine whether substantial doubt exists regarding the entity’s going concern presumption, which generally refers to an entity’s ability to meet its obligations as they become due. If substantial doubt exists but is not alleviated by management’s plan, the footnotes must specifically state that “there is substantial doubt about the entity’s ability to continue as a going concern within one year after the financial statements are issued.” In addition, if substantial doubt exists, regardless of whether such doubt was alleviated, entities must disclose (a) principal conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern (before consideration of management’s plans, if any); (b) management’s evaluation of the significance of those conditions or events in relation to the entity’s ability to meet its obligations; and (c) management’s plans that are intended to mitigate the conditions or events that raise substantial doubt, or that did alleviate substantial doubt, about the entity’s ability to continue as a going concern. If substantial doubt has not been alleviated, these disclosures should become more extensive in subsequent reporting periods as additional information becomes available. In the period that substantial doubt no longer exists (before or after considering management’s plans), management should disclose how the principal conditions and events that originally gave rise to substantial doubt have been resolved. The ASU applies prospectively to all entities for annual periods ending after December 15, 2016, and to annual and interim periods thereafter. Early adoption is permitted. The Company has not yet adopted the provisions of ASU 2014-15.

In February 2016, FASB issued ASU No. 2016-02,Lease Accounting Topic 842. This ASU requires a lessee to recognize lease assets and liabilities on the balance sheet for all arrangements with terms longer than 12 months, themonths. The new standard applies a right-of-use (ROU) model that requires a lessee to record, for all leases with a lease term of more than 12 months, an asset representing its right to use the underlying asset for the lease term and a liability to make lease payments. The lease term is the non-cancellable period of the lease, and includes both periods covered by an option to extend the lease, if the lessee is reasonably certain to exercise that option, and periods covered by an option to terminate the lease, if the lessee is reasonably certain not to exercise that termination option. For leases with a lease term of 12 months or less, a practical expedient is available whereby a lessee may elect, by class of underlying asset, not to recognize an ROU asset or lease liability. A lessee making this accounting policy election would recognize lease expense over the term of the lease, generally in a straight-line pattern. The Lessorlessor accounting remains largely consistent with existing U.S. GAAP. The new standard takes effect in 2019 for public business entities and 2020 for all other entities. We haveThe Company has not adopted the provisions of ASU No. 2016-02. The Company is currently evaluating the impact of adopting ASU 2016-02 on its consolidated financial statements.

 

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In April 2016, the FASB issued ASU No. 2016-09,Compensation - Stock CompensationTopic 718: Improvements to Employee Share-based Payment Accounting. This ASU simplifies simplifying the accounting for stock compensation onshare-based payment transactions including the income tax accounting,consequences, classification of awards as either equity or liabilities estimating forfeitures, and classification on the statements of cash flow presentation. Based on this ASU, an entity should recognizeflows. Under the new standard, all excess tax benefits and tax deficiencies including(including tax benefits of dividends on share-based payment awards,awards) should be recognized as income tax expense or benefit inon the income statement; they do not need to include the effectsstatements of windfalls and shortfalls in the annualincome. We adopted ASU No. 2016-09 effective tax rate estimate from continuing operations used for interim reporting purposes.January 1, 2017. As a result of including income tax effects from windfalls and shortfalls in income tax expense, the calculationadoption of both basic and diluted EPS will be affected. The ASU also providesthis guidance, we made an accounting policy election for awards with service conditions to either estimaterecognize the numbereffect of awards that are expected to vest (consistent with existing U.S. GAAP) or account for forfeitures in compensation cost when they occur. There was an immaterial impact on results of operations and financial position and no impact on cash flows at adoption.

In November 2016, the FASB issued ASU No. 2016-18,Statement of Cash Flows, amending the presentation of restricted cash within the statement of cash flows. The new guidance requires that restricted cash be included within cash and cash equivalents on the statement of cash flows. The ASU increases the allowable statutory tax withholding threshold to qualifyis effective retrospectively for equity classification from the minimum statutory withholding requirements up to the maximum statutory tax rate in the applicable jurisdiction(s). The ASU clarifies that cash paid to a taxing authority by an employer when directly withholding equivalent shares for tax withholding purposes should be considered similar to a share repurchase, and thus classified as a financing activity. All other employer withholding taxes on compensation transactions and other events that enter into the determination of net income continue to be presented within operating activities. The new standard takes effect inreporting periods beginning after December 15, 2017, for public business entities and 2018 for all other entities.with early adoption permitted. The Company has not yet adopted the provisions of ASU No. 2016-09.2016-18 and does not expect it will have a material impact on the financial statements upon adoption.

In July 2017, the FASB issued ASU 2017-11,Accounting for Certain Financial Instruments with Down Round Features and Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. Part I of this ASU addresses the complexity of accounting for certain financial instruments with down round features. Down round features are features of certain equity-linked instruments (or embedded features) that result in the strike price being reduced on the basis of future equity offerings. Current accounting guidance requires financial instruments with down round features to be accounted for at fair value. Part II of the Update applies only to nonpublic companies and is therefore not applicable to the Company. The amendments in Part I of the Update change the classification analysis of certain equity-linked financial instruments (or embedded features) with down round features. When determining whether certain financial instruments should be classified as liabilities or equity instruments, a down round feature no longer precludes equity classification when assessing whether the instrument is indexed to an entity’s own stock. As a result, a freestanding equity-linked financial instrument (or embedded conversion option) no longer would be accounted for as a derivative liability at fair value as a result of the existence of a down round feature. For freestanding equity-classified financial instruments, the amendments require entities that present earnings per share (EPS) in accordance with Topic 260 to recognize the effect of the down round feature when it is triggered. That effect is treated as a dividend and as a reduction of income available to common shareholders in basic EPS. This Update is effective for public entities for fiscal years beginning after December 15, 2018. Early adoption is permitted. The Company is currently evaluatinghas not yet determined when it will adopt the impactprovisions of adopting ASU 2016-09this Update and has not yet determined the impact on its consolidated financial statements.statements upon adoption.

 

NOTE 4: PREPAID EXPENSES

 

Prepaid expenses consisted of the following:

 

 September 30,
2016
  December 31,
2015
  June 30,
2017
  December 31,
2016
 
Prepaid insurance  38,538   104,954   156,532   121,333 
Trade show     20,000 
Retainer and security deposits  39,218   39,218   

29,968

   14,218 
Financial exchange fees  21,000    
Other  42,995   49,121   20,870   16,050 
Total prepaid expenses $120,751  $193,293  $

228,370

  $171,601 

 

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NOTE 5: FURNITURE AND EQUIPMENT

 

Furniture and equipment consisted of the following:

 

  September 30, 
2016
  December 31, 
2015
 
Machinery and equipment $206,336  $206,337 
Leasehold improvements  84,539   79,518 
Total furniture and equipment  290,875   285,855 
Less: Accumulated depreciation  (206,338)  (114,287)
Total furniture and equipment, net $84,537  $171,568 
  June 30,
2017
  December 31,
2016
 
Furniture and equipment $170,916  $210,528 
Less: Accumulated depreciation  (151,927)  (155,409)
Total furniture and equipment, net $18,989  $55,119 

 

Depreciation expense for the three months ended SeptemberJune 30, 2017 and 2016 was $8,773 and 2015 was $29,698 and $32,620,$32,734, respectively, and $92,054$18,434, and $97,059,$62,353, for the ninesix months ended SeptemberJune 30, 2017 and 2016, and 2015, respectively.

 

NOTE 6: INTANGIBLE ASSETS

 

Intangible assets consisted of the following:

 

 September 30, December 31, 
 2016  2015  June 30,
2017
  December 31,
2016
 
Patents $1,630,000  $1,630,000  $639,000  $639,000 
Capitalized license costs  -   200,000 
Software  113,540   113,540   113,540   113,540 
Intangible assets  1,743,540   1,943,540 
Total intangible assets  752,540   752,540 
Less: Accumulated amortization  (341,641)  (242,975)  (166,857)  (112,100)
Total intangible assets, net $1,401,899  $1,700,565  $585,683  $640,440 

 

Intangible assets

Software amounted to $1,401,899 and $1,700,565$113,540 as of SeptemberJune 30, 20162017 and December 31, 2015, respectively, and consisted of patents, capitalized license costs and software acquired.2016. The amortization period for the purchased software is 3 years. Amortization expense related to software for the three months ended SeptemberJune 30, 2017 and 2016 was $6,759 and 2015 was $7,857, and $11,261, respectively, and $23,572was $19,614 and $34,090$15,714, for the ninesix months ended SeptemberJune 30 20162017 and 2015,2016, respectively.

 

Patents amounted to $1,630,000$639,000 as of SeptemberJune 30, 20162017 and December 31, 2015,2016, and mainly consisted of patents acquired from Acueity on September 30, 2012 in an asset purchase transaction. Patent assets are amortized based on their determined useful life, and tested annually for impairment. The amortization period wasis from 7 to 12 years. Amortization expense related to patents was $37,253$17,571 and $37,254 for the three months ended SeptemberJune 30, 20162017 and 2015,2016, respectively and $111,761was $35,142 and $74,508 for each of the ninesix months ended SeptemberJune 30, 20162017 and 2015,2016, respectively.

Capitalized license costs consist of fees paid to A5 Genetics KFT, Corporation, pursuant to which the Company received the world-wide (other than the European Union) exclusive license to use the software in the NextCYTE test. As the Company shifted its focus to developing pharmaceutical products and discontinued NextCYTE test development, the A5 agreement was terminated in February 2016 and the entire net assets of $163,333, including $36,666 in accumulated amortization was written off.

 

Future estimated amortization expenses as of SeptemberJune 30, 20162017 for the five succeeding years is as follows:

 

For the Year Ending December 31, Amounts 
2016 (includes the remainder of the year) $42,489 
2017  169,576 
For the years ending December 31, Amounts 
2017 (includes the remainder of the year) $48,282 
2018  149,623   73,433 
2019  149,015   70,285 
2020  149,015   70,285 
2021  70,285 
Thereafter  742,181   253,113 
 $1,401,899  $585,683 

 

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NOTE 7: PAYROLL LIABILITIES:LIABILITIES

 

Payroll liabilities consisted of the following:

 

  September 30, 
2016
  December 31,
2015
 
Accrued bonus payable $438,098  $555,345 
Accrued payroll liabilities  96,248   510,179 
Accrued vacation  100,701   93,811 
Total payroll liabilities $635,047  $1,159,335 

NOTE 8: DISCONTINUED OPERATIONS

On December 16, 2015, the Company entered into a Stock Purchase Agreement (the “Purchase Agreement”) with the NRLBH and NRL Investment Group, LLC (the “NRL Group”) pursuant to which the Company sold to the NRL Group all of its shares of common stock in the NRLBH as of that date. Under the terms of the Purchase Agreement, the Company retained its ownership of the Preferred Stock of the NRLBH, which constitutes approximately 19% of the outstanding capital stock of the NRLBH, and the Company will have the right to sell to the NRL Group on or after the fourth anniversary of the Purchase Agreement at the greater of $4,000,000 or fair market value. The Company has the right to receive earn-out payments from NRL Group starting in December 2016 up to a total of $10,000,000. The Earn-out Payments are payable to the Company each calendar month commencing with December 2016 and are equal to 6% of NRLBH gross sales calculated in accordance with U.S. Generally Accepted Accounting Principles. The operations of the NRLBH sold to the NRL Group were accounted for as discontinued operations as the operations and cash flows of the discontinued business were eliminated from ongoing operations of the Company and the Company has no significant involvement in the NRLBH’s operations after the disposal transaction. 

The results of the NRLBH were segregated from continuing operations and reflected as discontinued operations for the 2015 periods on the Company’s Consolidated Statements of Operations and cash flow for the three and six months ended September 30, 2015. The loss from discontinued operations related to the operations of the NRLBH for the three and nine months ended September 30, 2015 was as follows:

  Three Months
Ended
September 30,
2015
  Nine Months
Ended 
September
30,
2015
 
Revenue $772,591  $5,337,911 
Cost of revenue  (311,074)  (3,365,901)
Gross profit  461,517   1,972,010 
Expenses:        
Selling expenses  239,427   829,174 
Research and development expenses  141,388   509,796 
General and administrative expenses  625,499   1,213,795 
Other expenses, net  5   49,559 
Net loss from discontinued operations $(544,802) $(630,314)
  June 30,
2017
  December 31,
2016
 
Accrued bonus payable $280,008  $609,337 
Accrued vacation  134,865   94,514 
Accrued payroll liabilities  67,547   66,048 
Total payroll liabilities $482,420  $769,899 

 

NOTE 9:8: STOCKHOLDERS’ EQUITY

 

The Company is authorized to issue a total of 85,000,000 shares of stock consisting of 75,000,000 shares of Common Stock,common stock, par value $0.015 per share, and 10,000,000 shares of Preferred Stock,preferred stock, par value $0.001 per share. The Company has designated 750,000 shares of Series A Junior Participating Preferred Stock, par value $0.001 per share, and 4,000 shares of Series A Convertible Preferred Stock, par value $0.001 per share through the filingfilings of certificatecertificates of designation with the Delaware Secretary of State.

 

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On May 19, 2014, the Company adopted a stockholder rights agreement which provides that all stockholders of record on May 26, 2014 received a non-taxable distribution of one preferred stock purchase right for each share of the Company’s common stock held by such stockholder. Each right is attached to and trades with the associated share of common stock. The rights will become exercisable only if one of the following occurs: (1) a person becomes an “Acquiring Person” by acquiring beneficial ownership of 15% or more of the Company’s common stock (or, in the case of a person who beneficially owned 15% or more of the Company’s common stock on the date the stockholder rights agreement was executed, by acquiring beneficial ownership of additional shares representing 2.0% of the Company’s common stock then outstanding (excluding compensatory arrangements)), or (2) a person commences a tender offer that, if consummated, would result in such person becoming an Acquiring Person. If a person becomes an Acquiring Person, each right will entitle the holder, other than the Acquiring Person and certain related parties, to purchase a number of shares of the Company’s common stock with a market value that equals twice the exercise price of the right. The initial exercise price of each right is $15.00, so each holder (other than the Acquiring Person and certain related parties) exercising a right would be entitled to receive $30.00 worth of the Company’s common stock. If the Company is acquired in a merger or similar business combination transaction at any time after a person has become an Acquiring Person, each holder of a right (other than the Acquiring Person and certain related parties) will be entitled to purchase a similar amount of stock of the acquiring entity. 

 

2015 and 2016 Issuances of Additional Shares to Aspire Capital

During the first quarter of 2015, we sold a total of 176,880 shares of common stock to Aspire Capital Fund, LLC (“Aspire Capital”) under the stock purchase agreement dated November 8, 2013 with aggregate gross proceeds to us of $4,292,349. No shares remain available for sale to Aspire Capital under the terms of the November 8, 2013 agreement with them.

On May 26, 2015, we entered into a new common stock purchase agreement with Aspire Capital, which provided that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital was committed to purchase up to an aggregate of $25.0 million of shares of our common stock over the 30-month term of the purchase agreement. Concurrently with entering into the purchase agreement, we also entered into a registration rights agreement with Aspire Capital, in which we agreed to file one or more registration statements, as permissible and necessary to register under the Securities Act of 1933, registering the sale of the shares of our common stock that have been and may be issued to Aspire Capital under the purchase agreement.

 

On November 11, 2015, we terminated the May 26, 2015our prior agreement with Aspire Capital Fund, LLC (“Aspire Capital”) and entered into a new common stock purchase agreement. Concurrently with entering into the Purchase Agreement,new purchase agreement, we also entered into a registration rights agreement with Aspire Capital in which we agreed to register 405,747 shares of our common stock.

 

During the first quarter of 2016, we sold a total of 405,747 shares of Common Stockcommon stock to Aspire Capital Fund LLC under the stock purchase agreement dated November 11, 2015 with aggregate gross proceeds to the Company of $2,153,583.$2,177,083, or net proceeds of $2,133,973 after deducting costs of the offering. 

 

On May 25, 2016, wethe Company terminated the November 11, 2015 stock purchase agreement with Aspire Capital and entered into a new common stock purchase agreement with Aspire Capital which provided that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $10.0 million of shares of our common stock over the 30-month term of the purchase agreement, subject to the terms and conditions set forth therein. Concurrently with entering into the purchase agreement, wethe Company also entered into a registration rights agreement with Aspire Capital, in which wethe Company agreed to file one or more registration statements, as permissible and necessary to register under the Securities Act of 1933, registering the sale of the shares of our common stock that have been and may be issued to Aspire Capital under the purchase agreement. As part of the stock purchase agreement we issued 49,736 common shares as a commitment fee. The value of the common shares issued as a commitment fee of $198,523 havehas been reflected as an addition to common stock of $746 and $197,777 in additional paid in capital which will be amortized over the life of the stock purchase agreement. As of the date of filing this Quarterly Report with the SEC no shares of stock have been sold to Aspire Capital under the May 25, 2016 purchase agreement. In connection with our public offering that closed on April 3, 2017, we agreed not to utilize the financing arrangement with Aspire Capital until June 30, 2017 and on June 30, 2017 in connection with the temporary modification of our common stock warrants to allow for the net exercise of those warrants we agreed to extend this stand still for an additional 45 days.

 

2015 Offering of Common Stock and Pre-Funded Warrants

In June 2015, the Company entered into a Placement Agent Agreement with Roth Capital Partners, LLC. and Dawson James Securities, Inc. (the “2015 Placement Agents”), pursuant to which the Company issued and sold an aggregate of 96,934 shares of common stock at the purchase price of $17.25 per share and pre-funded warrants to purchase 240,733 shares of common stock (the “Pre-Funded Warrants”) at a purchase price of $17.10 per share for net proceeds of $5.2 million after deducting $577,790 of offering expenses (the “2015 Offering”). Each Pre-Funded Warrant was exercisable for $0.15 per share and all of these warrants had been exercised as of December 31, 2015.

2016 Public Offering of Common Stock

 

In August 2016, the Company completed an underwritten public offering of 1,150,000 shares of Common Stockcommon stock at a price per share of $2.50, with gross proceeds of $2,875,000 to the Company, or net proceeds of $2,645,000$2,561,896 after deducting underwriter discounts, commissions, non accountablenon-accountable expense allowance and expense reimbursement.

2017 Public Offering of Class A and Class B Units Consisting of Common Stock, Series A Convertible Preferred Stock and Warrants

On March 28, 2017, the Company entered into an underwriting agreement with Aegis Capital Corp. relating to a public offering which closed on April 3, 2017. The offering generated gross proceeds to the Company of approximately $4.4 million and net proceeds of approximately $3.9 million after deducting underwriting discounts and commissions and other offering expenses paid by the Company. 

The offering included 664,000 Class A Units at a public offering price of $0.75 per Class A Unit, which consisted of 664,000 shares of common stock and warrants to purchase 664,000 shares of common stock. The offering also included 3,502 Class B Units at a public offering price of $1,000 per Class B Unit, which consisted of 3,502 shares of Series A Convertible Preferred Stock convertible into a total of 4,669,333 shares of common stock and warrants to purchase 4,669,333 shares of common stock. In addition, the underwriter exercised the over-allotment to purchase an additional 530,000 shares of common stock and warrants to purchase 530,000 shares of common stock, which are included in the gross proceeds of $4.4 million. The warrants had a per share exercise price of $0.9375, are exercisable immediately and will expire five years from the date of issuance.

 

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Series A Convertible Preferred Stock

 

The terms and provisions of our Series A Convertible Preferred Stock (the “Series A Preferred”) are as follows: 

Rank.  The Series A Preferred ranks on parity to our Common Stock.

Conversion.  Each share of the Series A Preferred is convertible into 1,333.33 shares of our Common Stock (subject to adjustment as provided in the related certificate of designation of preferences, rights and limitations). Holders of Series A Preferred are prohibited from converting Series A Preferred into shares of our common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 4.99% of the total number of shares of our Common Stock then issued and outstanding. However, any holder may increase or decrease such percentage to any other percentage not in excess of 9.99%, provided that any increase in such percentage shall not be effective until 61 days after such notice to us.

Liquidation Preference.  In the event of our liquidation, dissolution or winding-up, holders of Series A Preferred will receive the same amount that a holder of Common Stock would receive if the Series A Preferred were fully converted into shares of our Common Stock at the conversion price (disregarding for such purposes any conversion limitations) which amounts shall be paid pari passu with all holders of Common Stock.

Voting Rights.  Shares of Series A Preferred will generally have no voting rights, except as required by law. However, as long as any shares of Series A Preferred are outstanding, the Company shall not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Series A Preferred, (a) alter or change adversely the powers, preferences or rights given to the Series A Preferred or alter or amend the Certificate of Designation, (b) amend its certificate of incorporation or other charter documents in any manner that adversely affects any rights of the holders, (c) increase the number of authorized shares of Series A Preferred, or (d) enter into any agreement with respect to any of the foregoing.

Dividends.  Shares of Series A Preferred will not be entitled to receive any dividends, unless and until specifically declared by our board of directors. The holders of the Series A Preferred will participate, on an as-if-converted-to-common stock basis, in any dividends to the holders of common stock.

Redemption.  We are not obligated to redeem or repurchase any shares of Series A Preferred. Shares of Series A Preferred are not otherwise entitled to any redemption rights or mandatory sinking fund or analogous fund provisions.

2017 Warrants

The terms and conditions of the warrants included in the 2017 public offering are as follows:

Exercisability. The warrants are exercisable at any time after April 3, 2017 and expire 5 years from issuance. The warrants are exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed exercise notice and, at any time a registration statement registering the issuance of the shares of common stock underlying the warrants under the Securities Act is effective and available for the issuance of such shares, or an exemption from registration under the Securities Act is available for the issuance of such shares, by payment in full in immediately available funds for the number of shares of Common Stock purchased upon such exercise. If a registration statement registering the issuance of the shares of Common Stock underlying the warrants under the Securities Act is not then effective or available, the holder may only exercise the Warrant through a cashless exercise, in which case the holder would receive upon such exercise the net number of shares of Common Stock determined according to the formula set forth in the Warrant. No fractional shares of common stock will be issued in connection with the exercise of a warrant. In lieu of fractional shares, we will pay the holder an amount in cash equal to the fractional amount multiplied by the exercise price.


Exercise Limitation. A holder will not have the right to exercise any portion of the Warrant if the holder (together with its affiliates) would beneficially own in excess of 4.99% of the number of shares of our stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the warrants. However, any holder may increase or decrease such percentage to any other percentage not in excess of 9.99% upon at least 61 days’ prior notice from the holder to us.

Exercise Price. The exercise price of the warrants was initially $0.9375, which was reduced to $0.26 on June 30, 2017. The exercise price is subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting our common stock. The exercise price may also be adjusted downwards if we issue additional Common Stock (or equivalents) at a price below the exercise price of the Warrants while the Warrants remain outstanding.

Transferability. Subject to applicable laws, the Warrants may be offered for sale, sold, transferred or assigned without our consent. There is currently no trading market for the warrants and a trading market may not develop.

Fundamental Transactions. In the event of a fundamental transaction, as described in the warrants and generally including any reorganization, recapitalization or reclassification of our common stock, the sale, transfer or other disposition of all or substantially all of our properties or assets, our consolidation or merger with or into another person, the holders of the warrants will be entitled to receive, upon any subsequent exercise of the warrants and for each share of our Common Stock that would have been issuable upon such exercise immediately prior to the occurrence of a fundamental transaction, the number of shares of Common Stock of the successor or acquiring corporation or of the Company, if it is the surviving corporation, and any additional consideration receivable as a result of such fundamental transaction by a holder of the number of shares of Common Stock for which the warrants are exercisable immediately prior to such fundamental transaction. The holder of the Warrant may also require us or any successor entity to purchase the Warrant from the holder by paying to the holder an amount of cash equal to the Black Scholes value of the remaining unexercised portion of the Warrant on the date of or within 30 days after consummation of the fundamental transaction.

Rights as a Stockholder. Except as otherwise provided in the warrants or by virtue of such holder’s ownership of shares of our Common Stock, the holder of a Warrant does not have the rights or privileges of a holder of our Common Stock, including any voting rights, until the holder exercises the Warrant.

Accounting Treatment

The Company allocated the proceeds from the sale of the Class A and Class B units to the separate securities issued. The Company determined that, on the date of issuance, the warrants were not considered indexed to its own stock because the underlying instruments were not “fixed-for-fixed” due to the price protection and fundamental transaction provisions and, therefore, the warrants should be accounted for as liabilities. At the end of each reporting period, the changes in fair value of the warrants during the period are recorded in non-operating income (expense) in the consolidated statement of operations.

The Company allocated the amount representing the fair value of the warrants at the date of issuance separately to the warrant liability and recorded the remaining proceeds as common stock, in the case of the Class A units, or as Series A convertible preferred stock, in the case of the Class B units. Due to the allocation of a portion of the proceeds to the warrants, the Series A convertible preferred stock contained a beneficial conversion feature upon issuance, which was recorded in the amount of $1,284,066 based on the intrinsic value of the beneficial conversion feature. The discount on the Series A convertible preferred stock of $1,284,066 caused by allocation of the proceeds to the warrant was recorded as a deemed dividend upon issuance of the Series A convertible preferred stock. As a result, total deemed dividends of $2,568,132 was recorded upon issuance of the Series A convertible preferred stock, which is reflected as an addition to net loss in the consolidated statement of operations to arrive at net loss applicable to common shareholders.

Net Exercise of 2017 Warrants

On June 29, 2017, the Company offered to modify the rights of the holders of the warrants issued in the public offering the Company completed on April 3, 2017. The temporary modification included (a) lowering the exercise price of the warrants to $0.26 per share, (b) setting the applicable volume-weighted average price (VWAP) at $0.52 per share, and (c) allowing for temporary cashless exercise of the warrants for all holders that accepted the temporary modification before 8:00 a.m. Eastern daylight time on June 30, 2017. Holders of warrants to purchase a total of approximately 3.0 million shares of Common Stock accepted the offer resulting in the cancellation of those warrants and the issuance by the Company of a total of approximately1.5 million shares of Common Stock (including shares held in abeyance). The shares of Common Stock are registered under the Securities Act of 1933, as amended. If delivery of the shares of Common Stock pursuant to the foregoing would result in the holder exceeding the 4.99% “Beneficial Ownership Limitation” (as defined in the warrant) then the shares in excess of such 4.99% will be held in abeyance by the Company pending further instruction from the holder. In connection with the temporary modification, the Company agreed to extend the “Lock-up Period” of the underwriting agreement between the Company and Aegis Capital Corp., dated March 28, 2017, by 45 days and the Company agreed not to enter into any further amendments to the warrants during such extended Lock-up Period without the prior written consent of each holder. Upon exercise of these warrants, the amount of the warrant liability at the date of exercise was reclassified from warrant liability to additional paid-in capital.

The following table summarizes the 2017 liability warrant activity: 

  Shares  Weighted Average Exercise Price 
Outstanding as of December 31, 2016        
Warrants granted  5,863,332  $0.9375 
Warrants exercised  (2,991,666)  0.26 
Warrants cancelled        
Outstanding as of June 30, 2017  2,871,666  $0.26 

The Company estimated the fair value of the warrants using the Monte Carlo simulation (MCS) model, which is a type of income approach, where the current value of an asset is expressed as the sum of probable future cash flows across various scenarios and time frames discounted for risk and time. The significant assumptions include timing of future rounds of financing, timing and success rates of oncology clinical trials, and the probability of a merger and acquisition adjusted for a lack of marketability discount. The MCS model also includes a full term and an early conversion scenario that are each weighted at 50% in the final concluded fair value. 

Inputs used in the valuation of the warrants at the issuance date of April 3, 2017 and June 30, 2017 were as follows: 

Initial valuation   
Common stock price $0.75 
Exercise price $0.9375 
Expected Volatility  50%
Dividend Yield  0%
Risk-Free Interest Rate  0.79% - 1.88%
Expected Term (years)  0.24 - 5 
     
June 30, 2017 valuation    
Common stock price $0.50 
Exercise price $0.26 
Expected Volatility  50%
Dividend Yield  0%
Risk-Free Interest Rate  0.79% - 1.88%
Expected Term (years)  0.08-4.76 


Outstanding Warrants

 

As of SeptemberJune 30, 2016,2017, warrants to purchase 402,2283,273,894 shares of common stock were outstanding including:

 

 Outstanding
Warrants to
Purchase
Shares
  Exercise Price  Expiration Date Outstanding
Warrants to
Purchase
Shares
 Exercise Price Expiration Date
            
2011 private placement  283,470  $18.75 - 24.00  May 18, 2018 283,470 $18.75 - 24.00 May 8, 2018
Acueity warrants  21,667   75.00  September 30, 2017 21,667 75.00 September 30, 2017
2014 public offering  77,790   45.00  January 29, 2019 77,790 45.00 January 29, 2019
Placement agent fees for Company’s offerings  16,135   31.80 – 186.45  March - November, 2018 16,135 31.80 - 186.45 March - November, 2018
Outside consulting  3,166  $63.60  January 14, 2018 3,166 63.60 January 14, 2018
2017 public offering  2,871,666  0.26 April 3, 2022
  402,228         3,273,894     

Conversion of Series A Convertible Preferred Stock

During the three months ended June 30, 2017, certain holders of the Series A Convertible Preferred Stock exercised their conversion option and converted an aggregate of 2,663 shares of Series A Convertible Preferred Stock into 3,550,664 shares of the Company’s common stock based on the conversion ratio of 1,333.33 shares of Series A Convertible Preferred Stock to common stock.

NOTE 9: FAIR VALUE OF FINANCIAL INSTRUMENTS

Pursuant to the accounting guidance for fair value measurement and its subsequent updates, fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., the “exit price”) in an orderly transaction between market participants at the measurement date. The accounting guidance establishes a hierarchy for inputs used in measuring fair value that minimizes the use of unobservable inputs by requiring the use of observable market data when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on active market data. Unobservable inputs are inputs that reflect the assumptions market participants would use in pricing the asset or liability based on the best information available in the circumstances.

The fair value hierarchy is broken down into the three input levels summarized below:

Level 1—Valuations are based on quoted prices in active markets for identical assets or liabilities and readily accessible by us at the reporting date. Examples of assets and liabilities utilizing Level 1 inputs are certain money market funds, U.S. Treasuries and trading securities with quoted prices on active markets.

Level 2—Valuations based on inputs other than the quoted prices in active markets that are observable either directly or indirectly in active markets. Examples of assets and liabilities utilizing Level 2 inputs are U.S. government agency bonds, corporate bonds, commercial paper, certificates of deposit and over-the- counter derivatives.

Level 3—Valuations based on unobservable inputs in which there are little or no market data, which require the Company to develop its own assumptions. 

The following tables present the Company’s fair value hierarchy for all its financial assets, in thousands, by major security type measured at fair value on a recurring basis as of June 30, 2017:

  June, 30 2017 
  Estimated Fair Value  Level 1  Level 2  Level 3 
Assets:                
  $   $   $   $  
Liabilities:                
Common Stock Warrant Liability $864,371          $864,371 

There were no financial assets outstanding that were required to be measured at fair value at December 31, 2016.

Warrants containing provisions that could require the Company to settle the warrants in cash in an event outside the Company’s control or that have price protection rights are accounted for as liabilities, with changes in the fair values included in net loss for the respective periods. Because some of the inputs to the valuation model are either not observable or are not derived principally from or corroborated by observable market data by correlation or other means, the warrant liability is classified as Level 3 in the fair value hierarchy.

The following table summarizes the changes in the Company’s Level 3 warrant liability for the six months ended June 30, 2017:

June 30, 2017
Warrant liability
Beginning balance$
Issuances of warrants1,612,417
Warrant exercises(900,493)
Change in fair value152,447
Ending balance864,371

There were no transfers between Level 1, Level 2 or Level 3 for the three and six months ended June 30, 2017 and year ended December 31, 2016.

 

NOTE 10: NET LOSS PER SHARE

 

The Company accounts for and discloses net loss per common share in accordance with FASB ASCAccounting Standards Codification (“ASC”) Topic 260,Earnings Per Share. Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding. In addition, in computing the dilutive effect of convertible securities, the numerator is adjusted to add back any convertible preferred dividends. Diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares that would have been outstanding during the period assuming the issuance of common shares for all potential dilutive common shares outstanding. Potential common shares consist of shares issuable upon the exerciseconversion of Series A preferred stock, and potential future exercises of outstanding stock options and common stock warrants. Because the inclusion of potential common shares would be anti-dilutive.anti-dilutive for all periods presented, diluted net loss per common share is the same as basic net loss per common share for those periods. 

The following table summarizes the Company’s calculation of net loss per common share:

             
  Three Months Ended
June 30,
  Six Months Ended
June 30,
 
  2017  2016  2017  2016 
Net Loss Per share            
Numerator            
             
Net loss $2,241,489  $1,722,383  $3,945,043  $4,049,920 
Deemed dividend attributable to preferred stock $2,568,132     $2,568,132     
Net loss attributable to common shareholders $4,809,621  $1,722,383  $6,513,175  $4,049,920 
Denominator                
Weighted average common shares outstanding  7,476,046   2,587,871   5,641,671   2,485,853 
Basic and diluted net loss per share $0.64  $0.67  $1.15  $1.63 

 

The following table sets forth the number of potential common shares excluded from the calculation of net loss per diluted share for the three months and ninesix months ended SeptemberJune 30, 20162017 and 20152016 because the effect of them would be anti-dilutive:

 

 Three Months Ended  
September 30,
  Nine Months Ended
September 30,
  Three Months Ended  
June 30,
  Six Months Ended
June 30,
 
 2016  2015  2016  2015  2017  2016  2017  2016 
Options to purchase common stock  414,177   287,494   414,177   287,494   1,121,567   394,090   754,093   394,090 
Series A convertible preferred stock  2,184,356       1,098,212     
Warrants to purchase common stock  402,228   642,962   402,228   642,962   6,139,797   402,228   3,286,862   402,228 
Total  816,405   930,456   816,405   930,456   9,445,720   796,318   5,139,167   796,318 

 

NOTE 11: INCOME TAXES

 

Deferred income tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial reporting and tax bases of assets and liabilities and are measured using enacted tax rates in effect for the year in which those temporary differences are expected to be recovered or settled. A valuation allowance is provided for the amount of deferred tax assets that, based on available evidence, are not expected to be realized. 

 

As a result of the Company’s cumulative losses, management has concluded that a full valuation allowance against the Company’s net deferred tax assets is appropriate. No income tax liabilities existed as of SeptemberJune 30, 20162017 and December 31, 20152016 due to the Company’s continuing operating losses.

 

NOTE 12: CONCENTRATION OF CREDIT RISK

 

Financial instruments that potentially subject the Company to concentration of credit risk consist principally of cash deposits. Accounts at each institution are insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000. At SeptemberJune 30, 20162017 and December 31, 2015,2016, the Company had $4,138,177$3,440,023 and $3,465,895$2,777,962 in excess of the FDIC insured limit, respectively.

 

13

NOTE 13: COMMITMENTS AND CONTINGENCIES

 

Lease Commitments

 

The future minimum lease payments due subsequent to SeptemberJune 30, 20162017 under all non-cancelable operating and capital leases for the next five years are as follows:

 

Year Ending December 31, Operating Leases Amount  Operating Leases
Amount
 
2016 (remainder of year) $87,812 
2017  23,470 
2017 (remainder of year) $4,930 
Total minimum lease payments $111,282  $4,930 

 

The total rent expense for the three and six months ended SeptemberJune 30, 2017 and June 30, 2016 was $7,395 and 2015 was $87,315 and $154,291,$18,540, respectively and $238,565$78,600 and $469,748 for the nine months ended September 30, 2016 and 2015,$157,200, respectively. Rent expense was included in general and administrative expenses for both years.  

 

Purchase CommitmentsLitigation and Contingencies

 

Effective May 19, 2016 the Company entered into a services agreement with KriSan Biotech Co. Ltd., a corporation organized under the laws of Taiwan, Republic of China (“KSB”). The agreement directs KSB to research and develop for the Company processes for manufacturing endoxifen and to produce an initial supply of endoxifen so that release and stability studies may be conducted. The Company has agreed to pay $136,000 to KSB when certain benchmarks have been delivered by KSB under the services agreement.

Litigation and Contingencies

On October 10, 2013, a putative securities class action complaint, captionedCook v. Atossa Genetics, Inc., et al., No. 2:13-cv-01836-RSM, was filed in the United States District Court for the Western District of Washington against us, certain of the Company’s directors and officers and the underwriters of the CompanyCompany’s November 2012 initial public offering.  The complaint alleges that all defendants violated Sections 11 and 12(a)(2), and that the Company and certain of its directors and officers violated Section 15, of the Securities Act by making material false and misleading statements and omissions in the offering’s registration statement, and that we and certain of our directors and officers violated Sections 10(b) and 20A of the Exchange Act and SEC Rule 10b-5 promulgated thereunder by making false and misleading statements and omissions in the registration statement and in certain of our subsequent press releases and SEC filings with respect to our NAF specimen collection process, our ForeCYTE Breast Health Test and our MASCT device. This action seeks, on behalf of persons who purchased our common stock between November 8, 2012 and October 4, 2013, inclusive, damages of an unspecific amount.

 

On February 14, 2014, the Court appointed plaintiffs Miko Levi, Bandar Almosa and Gregory Harrison (collectively, the “Levi Group”) as lead plaintiffs, and approved their selection of co-lead counsel and liaison counsel. The Court also amended the caption of the case to read In re Atossa Genetics, Inc. Securities Litigation.Litigation No. 2:13-cv-01836-RSM. An amended complaint was filed on April 15, 2014. The Company and other defendants filed motions to dismiss the amended complaint on May 30, 2014. The plaintiffs filed briefs in opposition to these motions on July 11, 2014. The Company replied to the opposition brief on August 11, 2014. On October 6, 2014 the Court granted defendants’ motion dismissing all claims against Atossa and all other defendants. The Court’s order provided plaintiffs with a deadline of October 26, 2014 to file a motion for leave to amend their complaint and the plaintiffs did not file such a motion by that date. On October 30, 2014, the Court entered a final order of dismissal. On November 3, 2014, plaintiffs filed a notice of appeal with the Court and have appealed the Court’s dismissal order to the U.S. Court of Appeals for the Ninth Circuit. On February 11, 2015, plaintiffs filed their opening appellate brief. Defendants’ filed their answering brief on April 13, 2015,The appeal was fully-briefed and plaintiffs filed their reply brieforal arguments were held on May 18, 2015. A hearing for2017. We are currently awaiting a decision from the appeal has not been set.Court.

 

14

The Company believes this lawsuit is without merit and plans to defend itself vigorously; however, failure by the Company to obtain a favorable resolution of the claims set forth in the complaint could have a material adverse effect on the Company’s business, results of operations and financial condition. Currently, the amount of such material adverse effect cannot be reasonably estimated, and no provision or liability has been recorded for these claims as of SeptemberJune 30, 2016.2017. The costs associated with defending and resolving the lawsuit and ultimate outcome cannot be predicted. These matters are subject to inherent uncertainties and the actual cost, as well as the distraction from the conduct of the Company’s business, will depend upon many unknown factors and management’s view of these may change in the future.

On January 28, 2016, the Company filed a complaint in the United States District Court for the District of Delaware captioned Atossa Genetics Inc. v. Besins Healthcare Luxembourg SARL , Case No. 1:16-cv-00045-UNA. The complaint asserts claims for breach of contract, breach of the implied covenant of good faith and fair dealing, and for declaratory relief against Defendant Besins Healthcare Luxembourg SARL (“Besins”). The complaint was served upon Besins on February 15, 2016. The Company’s claims arise from Besins’ breach of an Intellectual Property License Agreement dated May 14, 2015 (the “License Agreement”), under which Besins licensed to the Company the worldwide exclusive rights to develop and commercialize Afimoxifene Topical Gel, or AfTG, for the potential treatment and prevention of hyperplasia of the breast. The complaint seeks compensatory damages, a declaration of the parties’ rights and obligations under the License Agreement, and injunctive relief. On March 7, 2016, Besins filed its response to the Company’s complaint, generally denying liability for the Company’s claims and asserting counterclaims for breach of contract, fraud, negligent misrepresentation, and declaratory judgment. Besins seeks unspecified money damages and preliminary and permanent injunctive relief, among other forms of relief, for its counterclaims. The Company filed its answer to Besins’ counterclaims on March 31, 2016, in which the Company disputed Besins’ allegations and denied that Besins is entitled to relief on its counterclaims. On August 4, 2016, the parties entered into a settlement agreement pursuant to which the parties dismissed this legal action and have settled all claims and counterclaims. Pursuant to the settlement agreement, Besins assumed, and Atossa shall have no further rights to, 4-hydroxy tamoxifen and AfTG in return for a termination payment to Atossa in the total amount of $1,762,931.  The termination payment was received in August 2016 and has been included in other income on the Condensed Consolidated Statement of Operations for both the three and nine months ended September 30, 2016.

 

NOTE 14: STOCK BASED COMPENSATION  

 

Stock Options and Incentive Plan

On September 28, 2010, the Board of Directors approved the adoption of the 2010 Stock Option and Incentive Plan, or the 2010 Plan, to provide for the grant of equity-based awards to employees, officers, non-employee directors and other key persons providing services to the Company. Awards of incentive options may be granted under the 2010 Plan until September 2020. No other awards may be granted under the 2010 Plan after the date that is 10 years from the date of stockholder approval. An aggregate of 66,667 shares were initially reserved for issuance in connection with awards granted under the 2010 Plan and on May 18, 2016, an additional 133,333 shares were reserved for issuance under the 2010 Plan. On May 9, 2017, the stockholders approved an additional 1,500,000 shares for issuance under the 2010 Plan.

 

The following table presents the automatic additions to the 2010 Plan since inception pursuant to the “evergreen” terms of the 2010 Plan:

 

January 1, Number of
shares
  Number of
shares
 
2012  30,018  30,018 
2013  34,452  34,452 
2014  49,532  49,532 
2015  65,557  65,557 
2016  220,419  220,419 
2017  151,477 
Total additional shares  399,978   551,455 

 

The Company granted 0 and 185,245 additional1,716,323 options to purchase shares of common stock to employees and directors during the three and ninesix months ended SeptemberJune 30, 2016.2017. No options were exercised during the three and nineor six months ended SeptemberJune 30, 2016.2017. There are 140,888100,456 shares available for grant under the 2010 Plan as of SeptemberJune 30, 2016.2017.

 

Compensation costs associated with the Company’s stock options are recognized, based on the grant-date fair values of these options, over the requisite service period, or vesting period. Accordingly, the Company recognized stock based compensation expense of $257,389$181,408 and $317,986$200,187 for the three months ended SeptemberJune 30, 20162017 and 2015,2016, respectively and $650,053$336,115 and $703,726 ($633,962 from continuing operations and $69,764 from discontinued operations)$392,664 for the ninesix months ended SeptemberJune 30, 2017 and 2016, respectively. The fair value of stock options granted for the six months ended June 30, 2017 and 2015, respectively.

2016 was calculated using the Black-Scholes option-pricing model applying the following assumptions:

 

15
  Period ended June 30, 
  2017  2016 
       
Risk free interest rate  1.86% - 2.04%   1.48% - 1.55% 
Expected term  5.32- 6.36 years   5.58 - 6.06 years 
         
Dividend yield  - %    - %  
Expected volatility  112.86% - 114.19%   115.52% - 115.58% 

  


Options issued and outstanding as of SeptemberJune 30, 20162017 and their activities during the ninesix months then ended are as follows:

 

  Number of
Underlying
Shares
  Weighted-
Average
Exercise Price
Per Share
  Weighted-
Average
Contractual
Life Remaining
in Years
  Aggregate
Intrinsic Value
 
Outstanding as of January 1, 2016  240,930  $38.89      $- 
Granted                  185,245   3.95       - 
Forfeited  (35,751)  28.90       - 
Outstanding as of  September 30, 2016  390,424   25.81   7.36  $6,451,077 
Exercisable as of  September 30, 2016  242,356   41.1   5.54  $- 
Vested and expected to vest(1)  414,177  $28.95   7.02  $- 

(1)vested shares and unvested shares after a forfeiture rate is applied
  Number of
Underlying
Shares
  Weighted-
Average
Exercise Price
Per Share
  Weighted-
Average
Contractual
Life Remaining
in Years
  Aggregate
Intrinsic Value
 
Outstanding as of January 1, 2017  378,924  $26.25      $  
Granted  1,716,323   .47         
Forfeited  (3,167)  15.00         
Expired  (19,081)  25.05         
Outstanding as of June 30, 2017  2,072,999   4.10   9.25  $51,512 
Exercisable as of June 30, 2017  229,158   31.65   7.44  $  
Vested and expected to vest  2,072,999  $4.10   9.26  $51,512 

 

At SeptemberJune 30, 2016,2017, there were 237,1921,840,530 unvested options outstanding and the related unrecognized total compensation cost associated with these options was approximately $1.2 million.$1,427,000. This expense is expected to be recognized over a weighted-average period of 2.092.10 years.

 

NOTE 15: RELATED PARTY TRANSACTIONSSUBSEQUENT EVENTS

 

Shu-Chih Chen, Ph.D., a member of the Board of DirectorsSubsequent to June 30, 2017 and spouse of Steve C. Quay, Ph.D., M.D., the Company’s CEO, has provided consultancy services to the Company.  Those services primarily include providing scientific and technical expertise in Atossa’s negotiations and ongoing arrangements with the manufacturer of endoxifen which is located in Taiwan.  The cost of the services provided by Dr. Chen are approximately $25,000 through September 30, 2016 andthroughout August 11, 2017 an additional 1,656,666 common stock warrants have been approved by Atossa’s audit committee.

exercised at $0.26 per warrant for cash proceeds of $434,733. As of August 14, 2017 there are 1,215,000 common stock warrants still outstanding.

16

 

ITEM 2.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following discussion of the financial condition and results of operations should be read in conjunction with the financial statements and the related notes included elsewhere in this report. This discussion contains forward-looking statements, which are based on assumptions about the future of the Company’s business. The actual results could differ materially from those contained in the forward-looking statements. Please read “Forward-Looking Statements” included below for additional information regarding forward-looking statements.

 

Forward-Looking Statements

 

This report contains, in addition to historical information, certain information, assumptions and discussions that may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). We have made these statements in reliance on the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties, which could cause actual results to differ materially from those projected or anticipated. Although we believe our assumptions underlying our forward-looking statements are reasonable as of the date of this report, we cannot assure you that the forward-looking statements set out in this report will prove to be accurate. We typically identify these forward-looking statements by the use of forward-looking words such as “expect,” “potential,” “continue,” “may,” “will,” “should,” “could,” “would,” “seek,” “intend,” “plan,” “estimate,” “anticipate” or the negative version of those words or other comparable words. Forward-looking statements contained in this report include, but are not limited to, statements about:

 

·whether we can obtain approval from the U.S. Food and Drug Administration, or FDA, and foreign regulatory bodies, to sell, market and distribute our therapeutics and devices under development;

 

·

our ability to successfully complete clinical trials of our pharmaceutical candidates under development, including endoxifen and our intraductal microcatheters to administer therapeutics, including theour study we recently opened using fulvestrant; 

   
 

·

the success, cost and timing of our product and drug development activities and clinical trials, including whether the ongoing clinical study using our intraductal microcatheters to administer fulvestrant will enroll a sufficient number of subjects or be completed in a timely fashion or at all; 

   
 

·

our ability to contract with third-party suppliers, manufacturers and service providers, including clinical research organizations, and their ability to perform adequately;

 

·

our ability to successfully develop and commercialize new therapeutics currently in development or that we might identify in the future and in the time frames currently expected;

 

·

our ability to successfully defend ongoing litigation, including the November 3, 2014 appeal of a dismissal of a securities class action law suit filed against us, on October 10, 2013, and other similar complaints that may be brought in the future, in a timely manner and within the coverage, scope and limits of our insurance policies;

 

·

our ability to establish and maintain intellectual property rights covering our products;

 

·

our expectations regarding, and our ability to satisfy, federal, state and foreign regulatory requirements;

 

·

the accuracy of our estimates of the size and characteristics of the markets that our products and services may address;

 

·

our expectations as to future financial performance, expense levels and capital sources;

 

 

·

our ability to attract and retain key personnel; and

 

·

our ability to raise capital, including our ability to sell shares of common stock to Aspire Capital under the terms of the May 25, 2016 common stock purchase agreement with Aspire Capital.

17


  

These and other forward-looking statements made in this report are presented as of the date on which the statements are made. We have included important factors in the cautionary statements included in this report, particularly in the section titled “ITEM 1A. RISK FACTORS,” that we believe could cause actual results or events to differ materially from the anticipated results as set forth in the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any new information, future events or circumstances that may affect our business after the date of this report. Except as required by law, we do not intend to update any forward-looking statements after the date on which the statement is made, whether as a result of new information, future events or circumstances or otherwise.

 

Company Overview

 

We are a clinical-stage pharmaceutical company focused on the development ofdeveloping novel, proprietary therapeutics and delivery methods for the treatment of breast cancer and other breast conditions. Our leading program usesWe currently have three programs underway: two using our proprietary endoxifen (oral and topical formulations) and the other using our patented intraductal microcatheters which deliver pharmaceuticals throughmicrocatheter technology. Our proprietary oral and topical forms of endoxifen are the breast ducts. We initiatedsubject of a comprehensive Phase 1 clinical study in healthy women in Australia. Our patented microcatheter technology is in a Phase 2 clinical study that is also currently enrolling patients.

Approximately one in March 2016 using our microcatheterseight women will be diagnosed with breast cancer during their lifetime. Every two minutes an American woman is diagnosed with breast cancer; 40,000 die each year. Tamoxifen has been widely used for over 30 years to deliver fulvestrant as a potential treatment of ductal carcinoma in-situ, or DCIS,both treat and prevent breast cancer. ThisAdditional research has shown that it is themetabolites of tamoxifen, of which endoxifen is the most active that have potential therapeutic value.

 We are developing both oral and a topical formulation of endoxifen, which are now in a Phase 1 dose-finding clinical study is being conducted by Columbia University Medical Center Breast Cancer Programs. Our second pharmaceutical program under developmenta leading Clinical Research Organization in Australia. The study is orala placebo-controlled, repeat dose study of 48 healthy female volunteers. The primary end point is to assess the pharmacokinetics of both formulations of endoxifen for breast cancer patients who are refractoryover 28 days. The secondary endpoint is to tamoxifen. Endoxifen is an active metabolite of tamoxifen which is an FDA approved drug for breast cancer patients to prevent recurrence as well as new breast cancer. In May 2015 we began the development of Afimoxifene Topical Gel, or AfTG, for the treatmentassess safety and prevention of hyperplasia of the breast; however, that program has been transferred back to the licensor, Besins Healthcare, in return for a payment to us of $1.7 million. 

Through mid-2015, we were primarily focused on the development and commercialization of our medical devices and laboratory tests. Our medical devices include the ForeCYTE Breast Aspirator and the FullCYTE Breast Aspirator. These devices are intended for the collection of nipple aspirate fluid, or NAF, for cytological testing at a laboratory. Our laboratory tests have historically been developed and performed by The National Reference Laboratory for Breast Health, Inc., or the “NRLBH.” The NRLBH was our wholly-owned subsidiary until December 16, 2015 when, pursuant to a stock purchase agreement, we sold approximately 81% of the capital stock of the NRLBH to the NRL Investment Group, LLC.tolerability. We have determined thatcompleted enrollment in both the dispositionoral and topical arms of the lab business qualifies for reporting as a discontinued operation since the sale represents a strategic shift that will have a major effect on our operations and financial results. We have electedthis study. Subject to recognize any subsequent gainpositive results from the earn-out payments payable to us pursuant to the stock purchase agreement as they are determined realizable.

We are now focusing our business on our pharmaceutical programs and delivery methods. Our key objectives arethis study, we plan to advance our pharmaceutical candidates throughto one or more Phase 2 trials and then evaluate further development independently or through partners. clinical studies in the second half of 2017.

 

Our common stock is currently quoted on The NASDAQ Capital Market under the symbol “ATOS.”

 

Summary of Our Clinical-Stage Programs Under Development

 

DeliveryOral Endoxifen. We believe that up to 50% of Therapeutics viathe one million patients taking tamoxifen in the United States each year are refractory, meaning that they have inadequate endoxifen levels (for any number of reasons including low levels of a liver enzyme) and they have an increased risk for breast cancer recurrence. Subject to favorable results from our MicrocathetersPhase 1 study, we are planning to begin a Phase 2 study of oral endoxifen in the second half of 2017 for these patients who are refractory to tamoxifen. We are also evaluating oral endoxifen in the neo-adjuvant setting, meaning it would be used, to treat breast cancer before surgery to remove the cancerous tumor.

Topical Endoxifen. Our topical formulation is being developed for women with a condition called high breast density, which has been shown in studies to result in a higher risk of developing breast cancer. Subject to favorable results from our Phase 1 study, we are planning to begin a Phase 2 study of topical endoxifen for women with high breast density. The goal of this program is to reduce high breast density, which should result in the lowering of the risk of breast cancer. Topical endoxifen is also being evaluated for its potential in other breast conditions.

Microcatheter Technology.Our third program uses our patented microcatheter technology to deliver drugs through the nipple directly to the site of the cancer. The goals of this delivery method are to increase the amount of the drug getting to the targeted area while reducing the side effects caused by delivering the drug through the blood stream.


 

We believe our patented intraductal microcathetersmicrocatheter technology may be useful in delivering a number of therapeutics to the ducts in the breast. Doing so is intended to provide a therapeuticdrugs directly to the breast tissue. We must obtain FDA approval of any drug delivered via our intraductal microcatheters devices which will require expensive and time-consuming studies. For example, we must complete clinical studies to demonstrate the safety and tolerability of fulvestrant using our delivery method. We may not be successful in completing these studies and obtaining FDA approval.

18

The initial drug we are studying using our microcatheters for intraductal delivery is fulvestrant. Fulvestrant is FDA-approved for metastatic breast cancer. It is administered as a monthly intramuscular injection of two shots,injections, typically into the buttocks. In 2012, a published study documented that the single dose cost of intramuscular fulvestrant was approximately $12,000.

 

We own one issued patent and several pending applications directed to the treatment of breast conditions, including cancer, by the intraductal administration of therapeutics, including fulvestrant.

 

We do not yet have FDA’s input, but our preliminary analysis, subject to FDA feedback, is that the intraductal fulvestrant program could qualify for designation under the 505(b)(2) status. This would allow us to file with only clinical data and without having to perform additional, significant clinical or pre-clinical studies. So the path to market is both faster and less expensive thanare currently conducting a standard new drug application, or NDA, program.

To support this development program, we have successfully produced microcatheters for the fulvestrant Phase 2 clinical trial. The FDA has also issued a “Safe to Proceed” letter for our first Investigational New Drug application (IND) for the Phase 2 study and the institutional review board approval has also been received.

In March 2016, we opened enrollment in the study ATOS-2015-007, whichusing our microcatheter technology to deliver fulvestrant at Montefiore Medical Center. This trial is being conducted by The Columbia University Medical Center Breast Cancer Program. This is an 18 montha Phase 2 study in women with DCISductal carcinoma in situ (DCIS) or invasiveStage 1 or 2 breast cancer slated(invasive ductal carcinoma) scheduled for mastectomy or lumpectomy.lumpectomy within 30 to 45 days. This study will assessis assessing the safety, tolerability, cellular activity and distribution of fulvestrant when delivered directly into breast milk ducts of these patients compared to those who receive the same product intramuscularly. Six study participantsdrug by injection. Of the 30 patients required for full enrollment, six will receive the standard intramuscular fulvestrant doseinjection of 500 mg to establish the reference drug distribution,fulvestrant and 24 participants will receive fulvestrant by intraductal instillation utilizingwith our microcatheter device. The total dose administered via our microcatheters will not exceed 500 mg.

The study has been accepted for presentation at the CTRC-AARC San Antonio Breast Cancer Symposium to be held December 6-10, 2016. This prestigious symposium is “designed to provide state-of-the-art information on the experimental biology, etiology, prevention, diagnosis, and therapy of breast cancer and premalignant breast disease, to an international audience of academic and private physicians and researchers.” The study has been accepted in the “Ongoing Clinical Trials” category, which features studies that have not been completed and which does not permit the presentation of study results.

 

The primary endpoint of the clinical trial is to assesscompare the safety, tolerability and distribution of intraductally administered fulvestrant in women with DCISbetween the two routes of administration (intramuscular injection or Stage 1 or 2 invasive ductal carcinoma prior to mastectomy or lumpectomy.through our microcatheters). The secondary objectiveendpoint of the study is to determine if there are changes in the expression of Ki67 as well as estrogen and progesterone receptors between a pre-fulvestrant biopsy and post-fulvestrant surgical specimen.specimens. Digital breast imaging before and after drug administration in both groups will also be performed to determine the effect of fulvestrant on any lesions as well as breast density of the participant. Additional information aboutWe cannot provide an estimate of the study candate by which enrollment will be found at: https://clinicaltrials.gov/ct2/show/NCT02540330?term=atossa&rank=2.

Oral Endoxifencompleted in this study.

 

Our second pharmaceutical program underkey objectives are to advance our programs through Phase 2 trials and then evaluate further development is oral endoxifen for breast cancer patients who are refractory to tamoxifen. Endoxifen is an active metabolite of tamoxifen which is an FDA approved drug for breast cancer patients to prevent recurrence as well as new breast cancer. We believe that up to 50% of the one million women who take tamoxifen in the United States each year are refractory, meaning that they have inadequate endoxifen levels (for any number of reasons included low levels of a liver enzyme)independently or with partners.


Research and they have an increased risk for breast cancer recurrence.Development Phase

 

We have filed patent applications covering endoxifen and we are in the process of procuring an initial supply of the endoxifen drug for initial studies.

Afimoxifene Topical Gel (AfTG)

On May 14, 2015, we were granted the worldwide exclusive rights to developresearch and commercialize AfTG for the potential treatmentdevelopment phase and prevention of hyperplasia of the breast. The active pharmaceutical ingredient in AfTG is Afimoxifene (4-hydroxytamoxifen), which is an active metabolite of tamoxifen.

These AfTG rights were granted to us pursuant to a May 14, 2015, Intellectual Property License Agreement with Besins Healthcare Luxembourg SARL (the “License Agreement”). 

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Besins has informed us that they plan to develop AfTG for the reduction of breast density, which we believe is within the scope of our exclusive rights under the License Agreement. We have informed Besins that its efforts to develop AfTG for breast density would infringe our exclusive rights under the License Agreement, including our exclusive rights to develop AfTG for treatment and prevention of hyperplasia of the breast, and would constitute a breach of the License Agreement by Besins.

On January 28, 2016, we filed a complaint in the United States District Court for the District of Delaware captionedAtossa Genetics Inc. v. Besins Healthcare Luxembourg SARL Case No. 1:16-cv-00045-UNA (the “Litigation”). The complaint asserts claims for breach of contract, breach of the implied covenant of good faith and fair dealing, and for declaratory relief against Besins.  On March 7, 2016, Besins responded to our complaint by denying our claims and asserting counterclaims against us for breach of contract, fraud, and negligent misrepresentation and declaratory relief. We filed our answer to Besins’ counterclaims on March 31, 2016, in which the Company disputed Besins’ allegations and denied that Besins is entitled to relief on its counterclaims. On August 4, 2016, we and Besins agreed, pursuant to a Termination Agreement, to terminate the License Agreement, dismiss the Litigation, and settle all claims and counterclaims asserted in the Litigation.  We and Besins have further agreed, pursuant to and as set forth in the Termination Agreement, that Besins will assume, and we shall have no further rights to, all clinical, regulatory, manufacturing, and all other development and commercialization of 4-hydroxy tamoxifen and Afimoxifene Topical Gel (the “AfTG Program”). In consideration for our comprehensive relinquishment of all rights granted in the License Agreement, termination of the License Agreement, cessation of all efforts to develop Afimoxifene Gel, delivery of all API manufactured to date, assignment of a Drug Master File, delivery to Besins of the work product we have completed to date, and other consideration, Besins reimbursed us for out-of-pocket expenses incurred by us to pursue the AfTG Program and made a termination payment to us in the total amount of $1,762,931.

Our Pre-Clinical Programs Under Development

In addition to our clinical-stage pharmaceutical programs, we are in the process of evaluating other therapeutic candidates to treat breast conditions, including breast cancer. Factors we are considering in evaluating potential drug candidates include, for example, the ability to obtain expedited regulatory approval, significance of unmet medical need, size of the patient population, intellectual property opportunities and the anticipated pre-clinical and clinical pathway.

NRLBH and our Laboratory Tests

Through December 16, 2015, our laboratory tests consisted of NAF cytology tests, pharmacogenomics tests and various tests under development including our NextCYTE Breast Cancer Test. These tests were developed by the NRLBH, and in the case of the NAF cytology and pharmacogenomics tests, were also marketed and sold by the NRLBH. The NRLBH generally owned the equipment and supplies necessary to develop the tests and to perform the tests and generally contracted directly with third parties for necessary supplies and services to develop and conduct the tests.

Our Medical Devices

Our medical devices include the ForeCYTE Breast Aspirator and the FullCYTE Breast Aspirator, which collect specimens of nipple aspirate fluid (NAF) for cytological testing at a laboratory, and a universal transport kit to assist with the packaging and transport of NAF samples to a laboratory. We also own the exclusive rights to manufacture and sell various medical devices (although we do not currently maintain an inventory of our devices) consisting primarily of tools to assist breast surgeons, which we acquired from Acueity Healthcare in 2012. We are not currently commercializing our breast aspirator devices, transportation kits, tools for breast surgeons normarketing any NAF cytology tests.

Our patented intraductal microcatheter devices are being developed for the targeted delivery of potential pharmaceuticals, as described above.

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Revenue Sources

Our business has provided us with two historical revenue sources: (i) sales-based revenue from the sale of our medical devices, such as our ForeCYTE Breast Aspirator and FullCYTE Breast Aspirator and patient kits to distributors, physicians, breast health clinics, and mammography clinics and (ii) service,products or use-based, revenue from laboratory services performed by the NRLBH, such as preparation and interpretation of the NAF samples sent to our laboratory for analysis and pharmacogenomics tests. Our main source of revenue from October 2014 to December 2015 was from pharmacogenomics testing. We are no longer selling our medical devices and because of the sale of 81% of the stock in the NRLBH, we will generate no revenue from laboratory testing. NRLBH’s operations are presented as discontinued operations in our condensed consolidated financial statements.services. We do not anticipate generating additional revenue from other resources unless and until we develop and launch newour pharmaceutical programs.

 

Critical Accounting Policies and Estimates

 

In our Annual Report on Form 10-K10-K/A for the year ended December 31, 2015,2016, we disclosed our critical accounting policies and estimates upon which our financial statements are derived. There have been no changes to these policies since December 31, 2015.2016, other than discussed in the following paragraph. Readers are encouraged to review these disclosures in conjunction with the review of this report.

 

Results

Financial Instruments with Characteristics of OperationsBoth Liabilities and Equity

Three Months and Nine Months Ended September 30, 2016 and 2015

 

Revenue and Cost of Revenue: As a result of the sale of the NRLBH in December 2015, we generated no revenue or cost of revenue for the three months and nine months ended September 30, 2016. Revenue and cost of revenue from NRLBH activities are presented as discontinued operations for the three months and nine months ended September 30, 2015. The NLRBH had total net revenue of $772,591 and cost of revenue of $311,074, forDuring the three months ended SeptemberJune 30, 2015,2017, the Company issued certain financial instruments, including warrants to purchase common stock, which have characteristics of both liability and $5,337,911equity. Financial instruments such as warrants that are classified as liabilities are fair valued upon issuance and $3,365,901 forare remeasured at fair value at subsequent reporting periods with the nine months ended September 30, 2015, respectively, consistingresulting change in fair value recorded in other income/(expense). The fair value of mainly pharmacogenomics testing.warrants is estimated using valuation models that require the input of subjective assumptions including stock price volatility, expected life, and the probability of future equity issuances and their impact to the price protection feature. 

 

Results of Operations

Three and Six Months Ended June 30, 2017 and 2016

Operating ExpensesExpenses:: Total operating expenses were approximately $1.6$1.9 million, and $5.4$3.6 million for the three months and ninesix months ended SeptemberJune 30, 2016,2017, respectively, consisting of general and administrative (G&A) expenses of approximately $1.5$1.1 million and $5.0$2.2 million, respectively, and research and development (R&D) expenses of approximately $0.8 million and $1.4 million, respectively. Total operating expenses were approximately $1.7 million and $4.0 million for the three and six months ended June 30, 2016, respectively, consisting of G&A expense of approximately $1.6 million and $3.7 million, respectively and R&D expenses of approximately $85,000$0.2 million and $404,000$0.3 million, respectively. As a result of the sale of NRLBH, operating expenses related to the NRLBH are presented separately as discontinued operations for the three months and nine months ended September 30, 2015.

 

Operating expenses from continuing operations for the three months and nine months ended September 30, 2016 decreased approximately $2.2 million and $4.9 million, or 59.4% and 47.1% respectively, from approximately $3.8 million and $10.3 million for the three months and nine months ended September 30, 2015, respectively, which consisted of G&A expenses of approximately $2.4 million and $7.2 million, respectively, R&D expenses of approximately $949,000 and $1.9 million, respectively, and selling expenses of approximately $499,000 and $1.2 million, respectively. The decrease inTotal operating expenses is mainly attributed to the 2015 launch of new devices and services which are not being pursued in 2016 and investing more in new R&D programs in the first quarter of 2015 compared to 2016.  

Selling Expenses: As a result of the sale of NRLBH and discontinuing commercialization of our devices in Europe and the United States, we incurred no selling expenses for the three and ninesix months ended SeptemberJune 30, 2016. Selling expenses, for2017 as compared to the three monthssame periods of 2016 increased approximately $0.2 million or 11.8% and nine months ended September 30, 2015 were approximately $499,000 and $1.2decreased $0.4 million respectively, consisting of compensation expenses, travel, and advertisement as a result of ForeCYTE and FullCYTE launch and commercialization in Europe and the United States. We do not expect any significant selling expenses during 2016, as we continue focusing on developing our pharmaceutical programs and until we receive regulatory clearance to commercialize our new products.or 10.0%, respectively.   

 

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General and Administrative Expenses: G&A expenses for continuing operations for the three months and nine months ended SeptemberJune 30, 20162017 were approximately $1.5 million and $5.0 million, respectively,$1,072,000, a decrease of approximately $922,000 and $2.2 million, respectively,$481,000 or 38.5% and 30.6% respectively,31.0%, from approximately $2.4 million and $7.2 million, respectively,$1.553,000, for the same periodsperiod  in 2015.2016. G&A expenses for the six months ended June 30, 2017 were approximately $2,215,000, a decrease of $1,516,000 or 40.5%, from approximately $3,731,000 for the same period in 2016. G&A expenses consist primarily of personnel and related benefit costs, facilities, professional services, insurance, and public company related expenses. The decrease in G&A expenses is mainly attributed to cost reductionsa reduction in payroll expenses resulting from sale of the NRLBHa decrease in headcount, rent, and discontinuing the commercialization of our breast aspirators.exit costs incurred in 2016 that were not incurred in 2017.

 

Research and Development Expenses: R&D expenses for the three months and ninesix months ended SeptemberJune 30, 20162017 were approximately $85,000$824,000, and $404,000$1,368,000, respectively, a decreasean increase of approximately $864,000$655,000, or 387.6% and $1.5 million respectively,$1,049,000 or 91.0% and 78.6% respectively,328.87% from the three months and ninesix months ended SeptemberJune 30, 2015.2016, respectively. The decreaseincrease in R&D expenses is attributed to discontinuing further development of the FullCYTE Microcatheters, FullCYTE Breast Aspirator, NextCYTE testsalaries, manufacturing and AfTG late in 2015 and early in 2016. During the first quarter of 2016, we focused all our R&D efforts on the fulvestrant clinical trial thatexpenses associated with our endoxifen program for which manufacturing commenced in March 2016at the beginning of 2017 and the clinical studies commenced in the second and third quarter of 2016 we focused our R&D efforts on initiating our oral endoxifen program.2017. We expect our R&D expenses to increase throughout 2016 and into 2017 as we continue the clinical trial of fulvestrant administered via our microcatheters and as we continue the development of endoxifen and potentially other indications and pharmaceuticals.

Discontinued operations: As a result of the sale of NRLBH in December 2015, the 2015 financial results of the NRLBH are presented separately as discontinued operations in the Company’s Consolidated Statements of Operations for all periods presented. The following summarizes the loss from discontinued operations for the three and nine months ended September 30, 2015:

 

  Three Months
Ended September
30,
2015
  Nine Months
Ended September
30,
2015
 
Revenue $772,591  $5,337,911 
Cost of revenue  (311,074)  (3,365,901)
Gross profit  461,517   1,972,010 
Expenses:        
Selling expenses  239,427   829,174 
Research and development expenses  141,388   509,796 
General and administrative expenses  625,499   1,213,795 
Other expenses, net  5   49,559 
Net loss from discontinued operations $(544,802) $(630,314)

Liquidity and Capital Resources

 

We have a history of operating losses as we have focused our efforts on raising capital and building our products and services in our pipeline. The Company’s consolidated financial statements are prepared using generally accepted accounting principles in the United States of America applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred net losses and negative operating cash flows since inception. For the ninesix months ended SeptemberJune 30, 2016,2017, the Company recorded a net loss of $3.8approximately $3.9 million, and used $4.0approximately $3.2 million of cash in operating activities. As of SeptemberJune 30, 2016,2017, the Company had approximately $4.4$3.7 million in cash and cash equivalents and working capital of approximately $3.7$2.1 million. The Company has not yet established an ongoing source of revenue sufficient to cover its operating costs and allow it to continue as a going concern. The ability of the Company to continue as a going concern is dependent on the Company obtaining adequate capital to fund operating losses until it becomes profitable. The Company can give no assurances that any additional capital that it is able to obtain, if any, will be sufficient to meet its needs, or that any such financing will be obtainable on acceptable terms. If the Company is unable to obtain adequate capital, it could be forced to cease operations or substantially curtail is commercial activities. These conditions raise substantial doubt as to the Company’s ability to continue as a going concern. The accompanying financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts and classification of liabilities should the Company be unable to continue as a going concern.

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DuringWe expect that our existing resources will be sufficient to fund our planned operations for the first quarter of 2016, we sold 405,747 shares of common stocknext four to Aspire Capital undersix months, however, additional capital resources will be needed to fund operations for the November 2015 agreement with them for aggregate gross proceeds to us of $2,153,583. On May 25, 2016 we entered into a new common stock purchase agreement with Aspire Capital which provides that we may sell up to $10 million in common stock to Aspire Capital over the 30 month term of the agreement, subject to the terms and conditions set out in the stock purchase agreement, none of which have been sold as of the date of filing this Quarterly Report with the SEC.  On August 4, 2016, we entered into a settlement agreement with Besins Healthcare pursuant to which Besins paid us a total of $1.76 million. See Part II, Item 1 Legal Proceedings. In August 2016, we completed an underwritten public offering of 1,150,000 shares of Common Stock at a price per share of $2.50, with gross proceeds to us of $2,875,000, or proceeds of $2,645,000 after deducting underwriter discounts, commissions, non accountable expense allowance and expense reimbursement.next twelve months.

 

Our ability to continue as a going concern is dependent on our obtaining additional adequate capital to fund additional operating losses until we become profitable. If we are unable to obtain adequate capital, we could be forced to cease operations.

 

Cash Flows

 

As of SeptemberJune 30, 2016, we2017 the Company had cash and cash equivalents of $4.4$3.7 million.

 

Net Cash Flows from Operating Activities: Net cash used in operating activities was approximately $4.0$3.2 million for the ninesix months ended SeptemberJune 30, 2016,2017, compared with approximately $10.0$4.7 million including $272,000 cash provided by discontinued operations, for the ninesix months ended SeptemberJune 30, 2015. We spent approximately $2.0 million in research and development for the nine months ended, September 30, 2015, compared to approximately $400,000 for the same period in 2016, the2016. The decrease in the 20162017 period as compared to 2015 resulting2016 results primarily from reductions in compensation from reduced headcount, reduced occupancy expenses, reduced consulting fees, and outside consulting; offset byfrom severance payments in 2016.2016 that were not incurred in 2017.

Net Cash Flows from Investing Activities: NetThere was no net cash used in investing activities wasfor the six months ended June 30, 2017, compared with approximately $5,000 for the ninesix months ended SeptemberJune 30, 2016, compared with approximately $111,000, including $44,000 from discontinued operations for the nine months ended September 30, 2015.2016. The decrease in 2016 for both periods2017 was primarily attributable to the reduction in purchases of fixed asset equipment in 20162017 as compared to 2015.2016.

Net Cash Flows from Financing Activities:Net cash provided by financing activities was approximately $4.7generated proceeds of $3.9 million for the ninesix months ended SeptemberJune 30, 2016,2017, as compared with approximately $9.5$2.1 million for the ninesix months ended SeptemberJune 30, 2015.2016. The decreaseincrease is mainly attributed to our completed public offering in the second quarter of 2017 as compared to a lower prices at which we were able to selllevel of sales of our stock to Aspire in 2016 and in our public offering in August 2016, compared to pricesthe second quarter of our stock and warrants in financing activities 2015.  2016. 

Funding Requirements

 

We expect to incur ongoing operating losses for the foreseeable future as we continue to develop our planned therapeutic programs including related clinical studies and other programs in the pipeline. We expect that our existing resources will be sufficient to fund our planned operations for at least the next sixfour to ninesix months. In addition to our cash and cash equivalents at SeptemberJune 30, 20162017 of approximately $4.4$3.7 million, we will be seeking to raise capital through sales of securities to third parties and existing stockholders.stockholders to fund operations later in the year. If we are unable to raise additional capital when needed, however, we could be forced to curtail or cease operations. Our future capital uses and requirements depend on the time and expenses needed to begin and continue clinical trials for our new drug developments. 

 

Additional funding may not be available to us on acceptable terms or at all. In addition, the terms of any financing may adversely affect the holdings or the rights of our stockholders. For example, if we raise additional funds by issuing equity securities or by selling debt securities, if convertible, further dilution to our existing stockholders would result. To the extent our capital resources are insufficient to meet our future capital requirements, we will need to finance our future cash needs through public or private equity offerings, collaboration agreements, debt financings or licensing arrangements.

 

If adequate funds are not available, we may be required to terminate, significantly modify or delay our development programs, reduce our planned commercialization efforts, or obtain funds through collaborators that may require us to relinquish rights to our technologies or product candidates that we might otherwise seek to develop or commercialize independently. Further, we may elect to raise additional funds even before we need them if we believe the conditions for raising capital are favorable.  

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Off-Balance Sheet Arrangements

 

We do not currently have, nor have we ever had, any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. In addition, we do not engage in trading activities involving non-exchange traded contracts.

 

Recent Accounting Pronouncements

 

In May 2014, theFebruary 2016, Financial Accounting Standards Board (the “FASB”(“FASB”) issued Accounting Standards UpdateUpdated (“ASU”) No. 2014-09,Revenue from Contracts with Customers: Topic 606 (“ASU 2014-09”), to supersede nearly all existing revenue recognition guidance under U.S. GAAP. The core principle of ASU 2014-09 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration that is expected to be received for those goods or services. ASU 2014-09 defines a five step process to achieve this core principle and, in doing so, it is possible more judgment and estimates may be required within the revenue recognition process than required under existing GAAP including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. ASU 2014-09 is effective for the Company in the first quarter of 2018 using either of two methods: (i) retrospective to each prior reporting period presented with the option to elect certain practical expedients as defined within ASU 2014-09; or (ii) retrospective with the cumulative effect of initially applying ASU 2014-09 recognized at the date of initial application and providing certain additional disclosures as defined per ASU 2014-09. We are currently evaluating the impact of its pending adoption of ASU 2014-09 on its consolidated financial statements. 

In August 2014, FASB issued ASU 2014-15,Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. This ASU requires the management to determine whether substantial doubt exists regarding the entity’s going concern presumption, which generally refers to an entity’s ability to meet its obligations as they become due. If substantial doubt exists but is not alleviated by management’s plan, the footnotes must specifically state that “there is substantial doubt about the entity’s ability to continue as a going concern within one year after the financial statements are issued.” In addition, if substantial doubt exists, regardless of whether such doubt was alleviated, entities must disclose (a) principal conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern (before consideration of management’s plans, if any); (b) management’s evaluation of the significance of those conditions or events in relation to the entity’s ability to meet its obligations; and (c) management’s plans that are intended to mitigate the conditions or events that raise substantial doubt, or that did alleviate substantial doubt, about the entity’s ability to continue as a going concern. If substantial doubt has not been alleviated, these disclosures should become more extensive in subsequent reporting periods as additional information becomes available. In the period that substantial doubt no longer exists (before or after considering management’s plans), management should disclose how the principal conditions and events that originally gave rise to substantial doubt have been resolved. The ASU applies prospectively to all entities for annual periods ending after December 15, 2016, and to annual and interim periods thereafter. Early adoption is permitted. We have not yet adopted the provisions of ASU 2014-15.

In February 2016, FASB issued ASU No. 2016-02,Lease Accounting Topic 842. This ASU requires a lessee to recognize lease assets and liabilities on the balance sheet for all arrangements with terms longer than 12 months, themonths. The new standard applies a right-of-use (ROU) model that requires a lessee to record, for all leases with a lease term of more than 12 months, an asset representing its right to use the underlying asset for the lease term and a liability to make lease payments. The lease term is the non-cancellable period of the lease, and includes both periods covered by an option to extend the lease, if the lessee is reasonably certain to exercise that option, and periods covered by an option to terminate the lease, if the lessee is reasonably certain not to exercise that termination option. For leases with a lease term of 12 months or less, a practical expedient is available whereby a lessee may elect, by class of underlying asset, not to recognize an ROU asset or lease liability. A lessee making this accounting policy election would recognize lease expense over the term of the lease, generally in a straight-line pattern. The Lessor accounting remains largely consistent with existing U.S. GAAP. The new standard takes effect in 2019 for public business entities and 2020 for all other entities. We haveThe Company has not adopted the provisions of ASU No. 2016-02. We are currently evaluating the impact of our pending adoption of ASU 2016-02 on our consolidated financial statements.

 

In April 2016, the FASB issued ASU No. 2016-09,Compensation - Stock CompensationTopic 718. This ASU simplifies simplifying the accounting for stock compensation onshare-based payment transactions including the income tax accounting, awardconsequences, classification estimating forfeitures,of awards as either equity or liabilities and classification on the statements of cash flow presentation. Based on this ASU, an entity should recognizeflows. Under the new standard, all excess tax benefits and tax deficiencies including(including tax benefits of dividends on share-based payment awards,awards) should be recognized as income tax expense or benefit inon the income statement; they do not need to include the effectsstatements of windfalls and shortfalls in the annualincome. We adopted ASU No. 2016-09 effective tax rate estimate from continuing operations used for interim reporting purposes.January 1, 2017. As a result of including income tax effects from windfalls and shortfalls in income tax expense, the calculationadoption of both basic and diluted EPS will be affected. The ASU also providesthis guidance, we made an accounting policy election for awards with service conditions to either estimaterecognize the numbereffect of awards that are expected to vest (consistent with existing U.S. GAAP) or account for forfeitures in compensation cost when they occur. There was an immaterial impact on results of operations and financial position and no impact on cash flows at adoption. 

In November 2016, the FASB issued ASU No. 2016-18,Statement of Cash Flows, amending the presentation of restricted cash within the statement of cash flows. The new guidance requires that restricted cash be included within cash and cash equivalents on the statement of cash flows. The ASU increases the allowable statutory tax withholding threshold to qualifyis effective retrospectively for equity classification from the minimum statutory withholding requirements up to the maximum statutory tax rate in the applicable jurisdiction(s).reporting periods beginning after December 15, 2017, with early adoption permitted. The ASU clarifies that cash paid to a taxing authority by an employer when directly withholding equivalent shares for tax withholding purposes should be considered similar to a share repurchase, and thus classified as a financing activity. All other employer withholding taxes on compensation transactions and other events that enter into the determination of net income continue to be presented within operating activities. The new standard takes effect in 2017 for public business entities and 2018 for all other entities. We haveCompany has not yet adopted the provisions of ASU No. 2016-09. We2016-18 and does not expect it will have a material impact on the financial statements upon adoption. 

 In July 2017, the FASB issued ASU 2017-11,Accounting for Certain Financial Instruments with Down Round Features and Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. Part I of this ASU addresses the complexity of accounting for certain financial instruments with down round features. Down round features are currently evaluatingfeatures of certain equity-linked instruments (or embedded features) that result in the strike price being reduced on the basis of future equity offerings. Current accounting guidance requires financial instruments with down round features to be accounted for at fair value. Part II of the Update applies only to nonpublic companies and is therefore not applicable to the Company. The amendments in Part I of the Update change the classification analysis of certain equity-linked financial instruments (or embedded features) with down round features. When determining whether certain financial instruments should be classified as liabilities or equity instruments, a down round feature no longer precludes equity classification when assessing whether the instrument is indexed to an entity’s own stock. As a result, a freestanding equity-linked financial instrument (or embedded conversion option) no longer would be accounted for as a derivative liability at fair value as a result of the existence of a down round feature. For freestanding equity-classified financial instruments, the amendments require entities that present earnings per share (EPS) in accordance with Topic 260 to recognize the effect of the down round feature when it is triggered. That effect is treated as a dividend and as a reduction of income available to common shareholders in basic EPS. This Update is effective for public entities for fiscal years beginning after December 15, 2018. Early adoption is permitted. The Company has not yet determined when it will adopt the provisions of this Update and has not yet determined the impact of our pending adoption of ASU 2016-09 on ourits consolidated financial statements.

statements upon adoption. 

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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

 

Not applicable.

 

ITEM 4. CONTROLS AND PROCEDURESPROCEDURES.

 

Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as of SeptemberJune 30, 2016.2017. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (“Exchange Act”), means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of September 30, 2016, ourOur principal executive officer and principal financial officer concluded that, as of such date,June 30, 2017, the Company’s disclosure controls and procedures were not effective at the reasonable assurance level.

 

No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the quarter ended SeptemberJune 30, 20162017 that has materially affected, or is reasonably likely to materially affect our internal control over financial reporting.disclosure controls and procedures.

 

For the year ended December 31, 2016, we identified a material weakness in that we did not design and maintain effective controls over the preparation of the 2016 impairment analysis of the Acueity patents, primarily because we did not include potential income taxes in the discounted cash flow model we used to estimate the fair value of the Acueity patents at December 31, 2016. This resulted in an initial overstatement of the fair value of the Acueity patents at December 31, 2016 in the amount of $366,000 and an initial understatement of the 2016 impairment charge and net loss by the same amount. We corrected our estimate and the related accounts prior to the issuance of the consolidated financial statements contained in our Annual Report on Form 10-K/A. Management’s remediation plan, which we are in the process of implementing, is to use appropriate valuation methodologies in future analyses that may be required to determine the fair value of these intangible assets and to seek the assistance of outside valuation resources, if necessary, in performing such analyses.

For the year ended December 31, 2016, we also identified a material weakness in that we did not design and maintain effective controls over the calculation of the weighted average number of shares outstanding and basic and diluted loss per share for the year ended December 31, 2016 because the calculation of weighted average shares outstanding did not include the shares of common stock we issued in August 2016. The preparation and review of the weighted average share calculation was not performed at an appropriately detailed level to prevent or detect this error, which led to a material error in our calculation of the weighted average number of shares outstanding and the net loss per share for the year ended December 31, 2016. During the first and second quarter of 2017, we began implementing a remediation plan to enhance the procedures performed to document our preparation of and to independently review the calculation of weighted average shares outstanding and income (loss) per share. Our enhanced review procedures and documentation standards were in place during the first and second quarter of 2017. The material weakness cannot be considered remediated until the control has operated for a sufficient period of time and until management has concluded that the control is operating effectively.

PART II OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS  

 

On October 10, 2013, a putative securities class action complaint, captioned Cook v. Atossa Genetics, Inc., et al., No. 2:13-cv-01836-RSM, was filed in the United States District Court for the Western District of Washington against us, certain of our directors and officers and the underwriters of our November 2012 initial public offering. The complaint alleges that all defendants violated Sections 11 and 12(a)(2), and that we and certain of our directors and officers violated Section 15, of the Securities Act by making material false and misleading statements and omissions in the offering’s registration statement, and that we and certain of our directors and officers violated Sections 10(b) and 20A of the Exchange Act and SEC Rule 10b-5 promulgated thereunder by making false and misleading statements and omissions in the registration statement and in certain of our subsequent press releases and SEC filings with respect to our NAF specimen collection process, our ForeCYTE Breast Health Test and our MASCT device. This action seeks, on behalf of persons who purchased our common stock between November 8, 2012 and October 4, 2013, inclusive, damages of an unspecific amount.

 

On February 14, 2014, the Court appointed plaintiffs Miko Levi, Bandar Almosa and Gregory Harrison (collectively, the “Levi Group”) as lead plaintiffs, and approved their selection of co-lead counsel and liaison counsel. The Court also amended the caption of the case to read In re Atossa Genetics, Inc. Securities Litigation.Litigation No. 2:13-cv-01836-RSM. An amended complaint was filed on April 15, 2014. The Company and other defendants filed motions to dismiss the amended complaint on May 30, 2014. On October 6, 2014 the Court granted defendants’ motion dismissing all claims against Atossa and all other defendants. On October 30, 2014, the Court entered a final order of dismissal. On November 3, 2014, plaintiffs filed a notice of appeal with the Court and have appealed the Court’s dismissal order to the U.S. Court of Appeals for the Ninth Circuit. On February 11, 2015, plaintiffs filed their opening appellate brief. Defendants filed an answering brief on April 13, 2015The appeal was fully briefed and plaintiffs fileda reply brief in support of their appealoral argument took place on May 18, 2015. A hearing for2017. We are currently awaiting a decision from the appeal has not been set.

Court.

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We believe this complaint is without merit and plan to defend ourselves vigorously; however failure to obtain a favorable resolution of the claims set forth in the complaint could have a material adverse effect on our business, results of operations and financial condition.  Currently, the amount of such material adverse effect cannot be reasonably estimated, and no provision or liability has been recorded for these claims as of SeptemberJune 30, 2016.2017. The costs associated with defending and resolving the complaint and ultimate outcome cannot be predicted. These matters are subject to inherent uncertainties and the actual cost, as well as the distraction from the conduct of our business, will depend upon many unknown factors and management’s view of these may change in the future.

On January 28, 2016, we filed a complaint in the United States District Court for the District of Delaware captionedAtossa Genetics Inc. v. Besins Healthcare Luxembourg SARL , Case No. 1:16-cv-00045-UNA (the “Litigation”). The complaint asserts claims for breach of contract, breach of the implied covenant of good faith and fair dealing, and for declaratory relief against Defendant Besins Healthcare Luxembourg SARL (“Besins”). The complaint was served upon Besins on February 15, 2016. Our claims arise from Besins’ breach of an Intellectual Property License Agreement dated May 14, 2015 (the “License Agreement”), under which Besins licensed to us the worldwide exclusive rights to develop and commercialize Afimoxifene Topical Gel, or AfTG, for the potential treatment and prevention of hyperplasia of the breast. The complaint seeks compensatory damages, a declaration of the parties’ rights and obligations under the License Agreement, and injunctive relief. On March 7, 2016, Besins filed its response to the Company’s complaint, generally denying liability for the Company’s claims and asserting counterclaims for breach of contract, fraud, negligent misrepresentation, and declaratory judgment.

On August 4, 2016, Atossa and Besins agreed, pursuant to a Termination Agreement, to terminate the License Agreement, dismiss the Litigation, and settle all claims and counterclaims asserted in the Litigation.  Atossa and Besins have further agreed, pursuant to and as set forth in the Termination Agreement, that Besins will assume, and Atossa shall have no further rights to, all clinical, regulatory, manufacturing, and all other development and commercialization of 4-hydroxy tamoxifen and Afimoxifene Topical Gel (the “AfTG Program”). In consideration for Atossa’s comprehensive relinquishment of all rights granted in the License Agreement, termination of the License Agreement, cessation of all efforts to develop Afimoxifene Gel, delivery of all API manufactured to date, assignment of a Drug Master File, delivery to Besins of the work product Atossa has completed to date, and other consideration, Besins reimbursed Atossa for out-of-pocket expenses incurred by Atossa to pursue the AfTG Program and made a termination payment in the total amount of $1,762,931.

 

ITEM 1A.  RISK FACTORS

 

RISK FACTORS

 

A purchase of our shares of Common Stock is an investment in our securities and involves a high degree of risk. You should carefully consider the following information about these risks, together with the other information contained in this report, before purchasing our securities. If any of the following risks actually occur, our business, financial condition and results of operations would likely suffer. In that case, the market price of the Common Stock could decline, and you may lose part or all of your investment in our company. Additional risks of which we are not presently aware or that we currently believe are immaterial may also harm our business and results of operations.

 

There hashave been no material changes to the risk factors described in the Company’sour Annual Report on Form 10-K,10-K/A, as filed with the SEC on March 21, 2017 except as follows:

Our shares of Common Stock are listed on The NASDAQ Capital Market, but we cannot guarantee that we will be able to satisfy the continued listing standards going forward.

Although our shares of Common Stock are listed on The NASDAQ Capital Market, we cannot ensure that we will be able to satisfy the continued listing standards of The NASDAQ Capital Market going forward. If we cannot satisfy the continued listing standards going forward, NASDAQ may commence delisting procedures against us, which could result in our stock being removed from listing on The NASDAQ Capital Market. On September 28, 2015, we received a letter from NASDAQ stating that the Company was not in compliance with NASDAQ Listing Rule 5550(a)(2), because the Company’s Common Stock failed to maintain a minimum closing bid price of $1.00 per share for 30 2016.consecutive business days. We regained compliance with the $1.00 minimum bid price requirement in September 2016 after effectuating a reverse stock split. On May 11, 2017, we received a letter from NASDAQ stating we are not in compliance with Rule 5550(a)(2) because our common stock failed to maintain a minimum closing bid price of $1.00 per share for 30 consecutive business days.  We have until November 7, 2017 to either regain compliance, or request additional time to regain compliance.

If our stock price does not satisfy the $1.00 minimum bid price requirement or we otherwise fail to satisfy other continued listing requirements, we may be delisted from NASDAQ, which could adversely affect our stock price, liquidity, and our ability to raise funding.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

Not applicable.

 

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ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

Not applicable.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5. OTHER INFORMATION

 

ITEM 6. EXHIBITS

 

(a)Exhibits

    Incorporated by
Reference Herein
  
Exhibit No. Description Form Date
4.13.1 Certificate of Amendment to AmendedDesignation of Preferences, Rights and Restated CertificateLimitations of IncorporationSeries A Convertible Preferred Stock Current Report on

Form 8-K, as Exhibit 4.110-Q 

 August 26, 2016May 11, 2017
       
10.1Settlement and Termination of License Agreement between Besins Healthcare Luxembourg SARL and its Affiliates and Atossa Genetics Inc. dated August 4, 2016Current Report on Form 8-K, as Exhibit 10.1August 5, 2016
10.2 Underwriting Agreement between Atossa Genetics Inc. and Aegis Capital Corp. as representative of the several underwriters, dated August 30, 2016March 28, 2017 Current Report on Form 8-K, as Exhibit 10.11.1 September 2, 2016April 4, 2017
       
10.310.2 2010 Stock Option and Incentive Plan, as amendedForm 10-QMay 11, 2017
31.1Certification pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 of Steven C. Quay Filed herewith  
       
31.131.2 Certification pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 of Steven C. QuayKyle Guse Filed herewith  
       
31.232.1 Certification pursuant to Rule 13a-14(a) under the Securities Exchange Act18 U.S.C. Section 1350 of 1934 of Kyle GuseSteven C. Quay Filed herewith  
       
32.132.2 Certification pursuant to 18 U.S.C. Section 1350 of Steven C. QuayFiled herewith
32.2Certification pursuant to 18 U.S.C. Section 1350 of Kyle Guse Filed herewith  
       
101 Interactive Data Files pursuant to Rule 405 of Regulation S-T  Filed herewith  

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

Date: NovemberAugust 14, 20162017

 

/s/ Steven C. Quay 
President and Chief Executive Officer 
(On behalf of the Registrant) 

/s/ Kyle Guse 
Kyle Guse 
Chief Financial Officer, General Counsel and Secretary 
(As Principal Financial and Accounting Officer) 

  

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