UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

[X]QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2019March 31, 2020

 

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: 001-38418

 

COCRYSTAL PHARMA, INC.

(Exact name of registrant as specified in its charter)

 

Delaware 35-2528215
(State or Other Jurisdiction of (I.R.S. Employer
Incorporation or Organization) Identification No.)

 

19805 N.North Creek Parkway Bothell, WA 98011
(Address of Principal Executive Office) (Zip Code)

 

Registrant’s telephone number, including area code:(786) 459-1831

 

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. Yes [X] No [  ]

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (Sec.232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes [X] 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 the definitions 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[X]  ]
    
Non-accelerated filer[  ]X]Smaller reporting company[X]
    
Emerging growth company[  ]  

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [  ]

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes [  ] No [X]

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class Trading Symbol(s) Name of each exchange on which registered
Common Stock COCP 

The Nasdaq Stock Market LLC

(The Nasdaq Capital Market)

 

As of August 9, 2019,May 13, 2020, the number of outstanding shares of the registrant’s common stock, par value $0.001 per share, was 31,620,646.52,140,699.

 

 

 

 

 

COCRYSTAL PHARMA, INC.

 

FORM 10-Q FOR THE QUARTER ENDED June 30, 2019MARCH 31, 2020

 

INDEX

 

Part I - FINANCIAL INFORMATION 
Item 1. 
Condensed Consolidated Balance SheetsF-1
Condensed Consolidated Statements of OperationsF-2
Condensed Consolidated Statements of Stockholders’ EquityF-3
Condensed Consolidated Statements of Cash FlowsF-4
Notes to the Condensed Consolidated Financial StatementsF-5
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations3
Item 3. Quantitative and Qualitative Disclosures About Market Risk7
Item 4. Controls and Procedures7
Part II - OTHER INFORMATION 
Item 1. Legal Proceedings98
Item 1.A. Risk Factors98
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds98
Item 3. Defaults Upon Senior Securities98
Item 4. Mine Safety Disclosures98
Item 5. Other98
Item 6. Exhibits98
SIGNATURES10

 

2 

 

 

Part I – FINANCIAL INFORMATION

 

COCRYSTAL PHARMA, INC.

 

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except per share data)

 

 June 30, 2019 December 31, 2018  March 31, 2020 December 31, 2019 
 (unaudited)    (unaudited)   
Assets                
Current assets:                
Cash $7,474  $2,723  $21,686  $7,418 
Restricted cash  50   29   50   50 
Accounts receivable  914   -   644   644 
Prepaid expenses and other current assets  95   191   202   169 
Total current assets  8,533   2,943   22,582   8,281 
        
Property and equipment, net  368   384   494   431 
Deposits  50   40   39   50 
Operating lease right-of-use assets, net  761   - 
Operating lease right-of-use assets, net (including $40 to related party)  634   677 
Goodwill  65,195   65,195   19,092   19,092 
Total assets $74,907  $68,562  $42,841  $28,531 
        
Liabilities and stockholders’ equity                
Current liabilities:                
Accounts payable and accrued expenses $1,361  $1,077  $1,659  $1,999 
Deferred rent  -   3 
Current maturities of finance lease liabilities  204   214   50   103 
Current maturities of operating lease liabilities  166   - 
Current maturities of operating lease liabilities (including $59 to related party)  182   177 
Derivative liabilities  123   263   34   7 
Total current liabilities  1,854   1,557   1,925   2,286 
Long-term liabilities:                
Finance lease liabilities  21   117   10   14 
Operating lease liabilities  614   - 
Operating lease liabilities (including $40 to related party)  475   523 
Total long-term liabilities  635   117   485   537 
        
Total liabilities  2,489   1,674   2,410   2,823 
        
Commitments and contingencies                
        
Stockholders’ equity:                
Common stock, $.001 par value; 100,000 shares authorized as of June 30, 2019 and December 31, 2018; 31,621 and 29,938 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively  32   30 
Common stock, $0.001 par value; 100,000 shares authorized as of March 31, 2020 and December 31, 2019; 52,141 and 35,150 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively  53   36 
Additional paid-in capital  258,021   253,949   277,628   260,932 
Accumulated deficit  (185,635)  (187,091)  (237,250)  (235,260)
Total stockholders’ equity  72,418   66,888   40,431   25,708 
        
Total liabilities and stockholders’ equity $74,907  $68,562  $42,841  $28,531 

 

See accompanying notes to condensed consolidated financial statements.

 

F-1

 

COCRYSTAL PHARMA, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

(in thousands, except per share data)

 

  

Three months ended

March 31,

 
  2020  2019 
Revenues:        
Collaboration revenue $461  $5,078 
Operating expenses:        
Research and development  1,283   878 
General and administrative  1,139   1,323 
Total operating expenses  2,422   2,201 
         
Income (loss) from operations  (1,961)  2,877 
Other (expense) income:        
Interest expense, net  (2)  (6)
Change in fair value of derivative liabilities  (27)  100 
Total other income (expense), net  (29)  94 
Net income (loss) $(1,990) $2,971 
Net income (loss) per common share, basic and diluted $(0.05) $0.10 
Weighted average number of common shares outstanding, basic  41,662   30,337 
Weighted average number of common shares outstanding, diluted  41,662   30,371 

  

Three months ended

June 30,

  

Six months ended

June 30,

 
  2019  2018  2019  2018 
             
Revenues:                
Collaboration revenue $592  $-  $5, 670  $- 
   592   -   5,670   - 
Operating expenses:                
Research and development  1,091   1,119   1,969   1,997 
General and administrative  1,051   1,013   2,374   2,205 
Total operating expenses  2,142   2,132   4,343   4,202 
                 
Income (loss) from operations  (1,550)  (2,132)  1,327   (4,202)
                 
Other (expense) income:                
Interest expense, net  (5)  (24)  (11)  (55)
Gain on settlement of mortgage note receivable  -   -   -   106 
Change in fair value of derivative liabilities  40   259   140   281 
Total other income, net  35   235   129   332 
                 
Income (loss) before income taxes  (1,515)  (1,897)  1,456   (3,870)
                 
Income tax benefit  -   554   -   973 
                 
Net income (loss) $(1,515) $(1,343) $1,456  $(2,897)
                 
Net income (loss) per common share, basic and diluted $(0.05) $(0.05)  0.05   (0.11)
Weighted average number of common shares outstanding, basic  31,621   27,716   30,986   26,050 
Weighted average number of common shares outstanding, diluted  31,621   27,716   31,006   26,050 

See accompanying notes to condensed consolidated financial statements.

F-2

COCRYSTAL PHARMA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(unaudited)

(in thousands)

  Common Stock  

Additional

Paid-in

  

Accumulated 

  

Total

Stockholders’

 
  Shares  Amount  Capital  Deficit  Equity 
Balance as of December 31, 2019  35,150  $36  $260,932  $(235,260) $25,708 
Stock-based compensation  -  $-  $107  $-  $107 
Sale of common stock, net of transaction costs  16,991  $17  $16,589  $-  $16,606 
Net loss  -  $-  $-  $(1,990) $(1,990)
Balance as of March 31, 2020  52,141  $53  $277,628  $(237,250) $40,431 

  

Common Stock

  

Additional

Paid-in

  

Accumulated 

  

Total

Stockholders’

 
  Shares  Amount  Capital  Deficit  Equity 
Balance as of December 31, 2018  29,938  $30  $253,949  $(187,091) $66,888 
Stock-based compensation  -   -   33   -   33 
Sale of common stock, net of transaction costs  1,682   2   3,926   -   3,928 
Net income  -   -   -   2,971   2,971 
Balance as of March 31, 2019  31,620  $32  $257,908  $(184,120) $73,820 

See accompanying notes to condensed consolidated financial statements.

F-3

COCRYSTAL PHARMA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)

  

Three months ended

March 31,

 
  2020  2019 
Operating activities:        
Net income (loss) $(1,990)  $2,971 
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:        
Depreciation and amortization expense  30   23 
Amortization of right of use assets  44   43 
Stock-based compensation  107   33 
         
Payments on operating lease liabilities  (44)   (27)
Change in fair value of derivative liabilities  27   (100)
Changes in operating assets and liabilities:        
Accounts receivable  -   (1,078)
Prepaid expenses and other current assets  (33)   22 
Deposits  11   - 
Accounts payable and accrued expenses  (340)   134 
Deferred rent  -   (3)
Net cash (used in) provided by operating activities  (2,188)   2,018 
         
Investing activities:        
Purchases of property and equipment  (93)   (25)
Net cash used in investing activities  (93)   (25)
         
Financing activities:        
Payments on finance lease liabilities  (57)   (52)
Proceeds from sale of common stock, net of transaction costs  16,606   3,928 
Net cash provided by financing activities  16,549   3,876 
Net increase in cash and restricted cash  14,268   5,869 
Cash and restricted cash at beginning of period  7,468   2,752 
Cash and restricted cash at end of period $21,736  $8,621 
         
SUPPLEMENTAL DISCLOSURE OF NON-CASH OPERATING ACTIVITIES:        
Recognition of operating lease right-of-use assets and operating lease liabilities upon adoption of ASC Topic 842,Leases $-  $833 

 

See accompanying notes to condensed consolidated financial statements.

 

F-2F-4

 

 

COCRYSTAL PHARMA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(unaudited)

(in thousands)

  Common Stock  

Additional

Paid-in

  Accumulated  

Total

Stockholders’

 
  Shares  Amount  Capital  Deficit  Equity 
Balance as of December 31, 2018  29,938  $30  $253,949  $(187,091) $66,888 
Stock-based compensation  -   -   33   -   33 
Sale of common stock, net of transaction costs  1,683   2   3,926   -   3,928 
Net income  -   -   -   2,971  2,971
Balance as of March 31, 2019  31,621   32   257,908   (184,120)  73,820 
Stock-based compensation  -   -   113   -   113 
Net loss  -   -   -   (1,515)  (1,515)
Balance as of June 30, 2019  31,621  $32  $258,021  $(185,635) $72,418 

  Common Stock  

Additional

Paid-in

  Accumulated  

Total

Stockholders’

 
  Shares  Amount  Capital  Deficit  Equity 
Balance as of December 31, 2017  24,275  $24  $243,419  $(138,043) $105,400 
Stock-based compensation  -   -   105   -   105 
Exercise of common stock options  127   -   184   -   184 
Net loss  -   -   -   (1,553)  (1,553)
Balance as of March 31, 2018  24,402  $24  $243,708  $(139,596) $104,136 
Sale of common stock, net of transaction costs  4,435   5   7,679   -   7,684 
Stock-based compensation  -   -   107   -   107 
Convertible debt instruments  1,085   1   2,061   -   2,062 
Exercise of common stock options  1   -   1   -   1 
Net loss  -   -   -   (1,344)  (1,344)
Balance as of June 30, 2018  29,923  $30  $253,556  $(140,940) $112,646 

See accompanying notes to condensed consolidated financial statements.

F-3

COCRYSTAL PHARMA, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)

  Six months ended
June 30,
 
  2019  2018 
       
Operating activities:        
Net income (loss) $1,456  $(2,897)
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:        
Depreciation and amortization expense  45   29 
Operating lease expense  72   - 
Stock-based compensation  146   212 
Interest expense, net  11   55 
Payments on operating lease liabilities  (53)  - 
Gain on settlement of mortgage note receivable  -   (106)
Change in fair value of derivative liabilities  (140)  (281)
Deferred income tax benefit  -   (973)
Changes in operating assets and liabilities:        
Accounts receivable  (914)  - 
Prepaid expenses and other current assets  96   (124)
Deposits  (10)  - 
Accounts payable and accrued expenses  284   (72)
Deferred rent  (3)  (14)
Net cash provided by (used in) operating activities  990   (4,171)
         
Investing activities:        
Purchases of property and equipment  (29)  (5)
Proceeds from settlement of mortgage note receivable  -   1,400 
Net cash (used in) provided by investing activities  (29)  1,395 
         
Financing activities:        
Payments on finance lease liabilities  (117)  - 
Proceeds from exercise of stock options  -   185 
Proceeds from sale of common stock, net of transaction costs  3,928   7,684 
Proceeds from issuance of convertible notes  -   1,000 
Net cash provided by financing activities  3,811   8,869 
         
Net increase in cash and restricted cash  4,772   6,093 
Cash and restricted cash at beginning of period  2,752   777 
Cash and restricted cash at end of period $7,524  $6,870 
         
SUPPLEMENTAL DISCLOSURE OF NON-CASH FINANCING ACTIVITIES:        
Recognition of operating lease right-of-use assets and operating lease liabilities upon adoption of ASC Topic 842,Leases $833  $- 
Issuance of commons stock upon conversion of notes payable $-  $2,062 

See accompanying notes to condensed consolidated financial statements.

F-4

COCRYSTAL PHARMA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

1. Organization and Business

 

Cocrystal Pharma, Inc. (“we”, the “Company” or “Cocrystal”), a clinical stage biopharmaceutical company incorporated in Delaware, has been developing novel technologies and approaches to create first-in-class andor best-in-class antiviral drug candidates since its initial funding in 2008. Our focus is to pursue the development and commercialization of broad-spectrum antiviral drug candidates that will transform the treatment and prophylaxis of viral diseases in humans. By concentrating our research and development efforts on viral replication inhibitors, we plan to leverage our infrastructure and expertise in these areas.

 

On January 18, 2018, the Company’s Board of Directors (the “Board”) filed an amendment (the “Amendment”) with the Delaware Secretary of State to affect a one-for-thirty reverse split (the “Reverse Stock Split”) of the Company’s class of common stock. The Amendment took effect on January 24, 2018. The Reverse Stock Split did not change the authorized number of shares of common stock. Pursuant to the terms of the Company’s then outstanding convertible notes (see Note 7 – Convertible Notes Payable), its options and warrants have been proportionately adjusted to reflect the Reverse Stock Split. A proportionate adjustment was made to the per share exercise price, number of shares issued, and shares reserved for issuance under all of the Company’s equity compensation plans.

All per share amounts and number of shares in the condensed consolidated financial statements and related notes presented have been retroactively restated to reflect the Reverse Stock Split.

The Company’s activities since inception have principally consisted of acquiring potential product and technology rights, raising capital, and performing research and development. Successful completion of the Company’s development programs, obtaining regulatory approvals of its products and, ultimately, the attainment of profitable operations is dependent on future events, including, among other things, its ability to access potential markets, secure financing, develop a customer base, attract, retain and motivate qualified personnel, and develop and maintain strategic alliances. Through DecemberMarch 31, 2018,2020, the Company has primarily funded its operations through equity offerings.

 

On January 31, 2019, the Company received an upfront non-refundable payment of $4,000,000 and anticipates future payments for employees and research expense reimbursements over the term of our collaboration with Merck Sharp & Dohme Corp. (“Merck”), effective January 2, 2019 (refer to Note 10 – Licenses and Collaborations).

The Company’s historical operating results indicate substantial doubt exists related to the Company’s ability to continue as a going concern. The Company has no pharmaceutical products approved for sale, has not generated any revenues to date from pharmaceutical product sales, and has incurred significant operating losses since inception. The Company has earned income from operations of $1,327,000 and incurred losses from operations of $4,202,000 in the six months ended June 30, 2019 and 2018, respectively, and incurred losses from operations of $1,550,000 and $2,132,000 in the three months ended June 30, 2019 and 2018, respectively.

The Company will need to continue obtaining adequate capital to fund its operations until it becomes profitable on a consistent basis. The Company can give no assurances that the additional capital it is able to raise, 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 its drug development activities. The Company expects to continue incurring substantial operating losses and negative cash flows from operations over the next several years during its pre-clinical and clinical development phases. The accompanying financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts and the classification of liabilities should the Company be unable to continue as a going concern.

F-5

2. Basis of Presentation and Significant Accounting Policies

Basis of Presentation

 

The accompanying condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) for interim financial information, the instructions to Form 10-Q and Article 10 of Regulation S-X set forth by the Securities and Exchange Commission (“SEC”). They do not include all of the information and notes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. The results of operations for the interim periods presented are not necessarily indicative of the results of operations for the entire fiscal year. For further information, refer to the consolidated financial statements and footnotes thereto included in the Company’s annual report on Form 10-K for the year ended December 31, 20182019 filed on April 1, 2019March 27, 2020 (“Annual Report”).

 

Principles of Consolidation

 

The condensed consolidated financial statements include the accounts of Cocrystal Pharma, Inc. and its wholly owned subsidiaries: RFS Pharma, LLC, Cocrystal Discovery, Inc., Cocrystal Merger Sub, Inc., Baker Cummins Corp. and Biozone Laboratories, Inc. Intercompany transactions and balances have been eliminated.

 

Segments

 

The Company operates in only one segment. Management uses cash flows as the primary measure to manage its business and does not segment its business for internal reporting or decision-making.

 

Use of Estimates

 

Preparation of the Company’s condensed consolidated financial statements in conformance with U.S. GAAP requires the Company’s management to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities in the Company’s condensed consolidated financial statements and accompanying notes. The significant estimates in the Company’s condensed consolidated financial statements relate to the valuation of equity awards and derivative liabilities, recoverability of deferred tax assets, estimated useful lives of fixed assets, and forecast assumptions used in the valuation of intangible assets and goodwill. The Company bases estimates and assumptions on historical experience, when available, and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis, and its actual results may differ from estimates made under different assumptions or conditions.

 

F-5

Concentrations of Credit Risk

 

Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash deposited in accounts held at two United StatesU.S. financial institutions, which may, at times, exceed federally insured limits of $250,000 for each institution where accounts are held. At June 30, 2019March 31, 2020 and December 31, 2018,2019, our primary operating account held approximately $7,474,000$21,686,000 and $2,723,000$7,418,000, respectively, and our collateral account balance heldwas $50,000 at a different institution was $50,000 and $29,000, respectively.institution. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risks thereof.

 

F-6

As of March 31, 2020, 100% of our revenue and receivables are from one customer, Merck Sharp & Dohme Corp. (“Merck”).

 

Cash and Restricted Cash

The Company considers all highly liquid investments with an original maturity from the date of purchase of three months or less to be cash equivalents, and the Company held no cash equivalents as of June 30, 2019 and 2018, nor as of December 31, 2018.

The following table provides a reconciliation of cash and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in thousands):

  June 30, 2019  June 30, 2018 
Cash $7,474  $6,841 
Restricted cash  50   29 
Total cash and restricted cash shown in the statements of cash flows $7,524  $6,870 

Restricted cash represents amounts pledged as collateral for financing arrangements that are currently limited to the issuance of business credit cards. The restriction will end upon the conclusion of these financing arrangements.

Leases

Prior to January 1, 2019, the Company accounted for leases under Accounting Standards Codification (“ASC”) 840, Accounting for Leases. Effective from January 1, 2019, the Company adopted the guidance of ASC 842,Leases, which requires an entity to recognize a right-of-use asset and a lease liability for virtually all leases. The Company adopted ASC 842 using a modified retrospective approach. As a result, the comparative financial information has not been updated and the required disclosures prior to the date of adoption have not been updated and continue to be reported under the accounting standards in effect for those periods. The adoption of ASC 842 on January 1, 2019 resulted in the recognition of operating lease right-of-use assets and lease liabilities of approximately $833,000 and did not result in a cumulative-effect adjustment to accumulated deficit.

F-7

Fair Value Measurements

 

FASB Accounting Standards Codification (“ASC”) 820 (“ASC 820”) defines fair value, establishes a framework for measuring fair value under generally accepted accounting principles and enhances disclosures about fair value measurements. Fair value is defined under ASC 820 as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value under ASC 820 must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value which are the following:

 

 Level 1 — quoted prices in active markets for identical assets or liabilities.
  
 Level 2 — other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement date.
  
 Level 3 — significant unobservable inputs that reflect management’s best estimate of what market participants would use to price the assets or liabilities at the measurement date.

 

The Company categorizes its cash and restricted cash as Level 1 fair value measurements. The Company categorizes its warrants potentially settleable in cash as Level 32 fair value measurements. The warrants potentially settleable in cash are measured at fair value on a recurring basis and are being marked to fair value at each reporting date until they are completely settled or meet the requirements to be accounted for as component of stockholders’ equity. The warrants are valued using the Black-Scholes option pricing model as discussed in Note 97 – Warrants.

 

The following tables present a summaryAt March 31, 2020 and December 31, 2019, the carrying amounts of fair values offinancial assets and liabilities, such as cash, accounts receivable, other assets, and accounts payable and accrued expenses approximate their fair values due to their short-term nature. The carrying values of notes payable approximate their fair values due to the fact that the interest rates on these obligations are re-measured at fair value at each balance sheet date presented as of June 30, 2019 and December 31, 2018, and their placement within the fair value hierarchy as discussed above (in thousands):

     

Quoted

Prices in

Active

Markets

  

Significant

Other

Observable

Inputs

  

Unobservable

Inputs

 
Description June 30, 2019  (Level 1)  (Level 2)  (Level 3) 
Assets:            
Cash and restricted cash $7,524  $7,524  $          -  $                   - 
Total assets $7,524  $7,524  $-  $- 
                 
Liabilities:                
Warrants potentially settleable in cash (Note 9) $123  $-  $-  $123 
Total liabilities $123  $-  $-  $123 

     Quoted
Prices in
Active
Markets
  Significant
Other
Observable
Inputs
  Unobservable
Inputs
 
Description December 31, 2018  (Level 1)  (Level 2)  (Level 3) 
Assets:                
Cash and restricted cash $2,752  $2,752  $           -  $                     - 
Total assets $2,752  $2,752  $-  $- 
                 
Liabilities:                
Warrants potentially settleable in cash (Note 9) $263  $-  $-  $263 
Total liabilities $263  $-  $-  $263 

F-8

based on prevailing market interest rates.

 

The Company has not transferred any financial instruments into or out ofCompany’s derivative liabilities are considered Level 3 classification during the six months ended June 30, 2019 and 2018. A reconciliation of the beginning and ending Level 3 liabilities is as follows (in thousands):2 measurements.

  

Fair Value Measurements Using

Significant Unobservable Inputs

(Level 3)

 
  June 30, 2019  June 30, 2018 
Balance, January 1, $263  $569 
Change in fair value of warrants potentially settleable in cash (Note 9)  (140)  (281)
Balance at June 30, $123  $288 

Goodwill and In-Process Research and Development

We account for business combinations using the acquisition method, recording the acquisition-date fair value of total consideration over the acquisition-date fair value of net assets acquired as goodwill. Acquisition-related costs, including banking, legal, accounting, valuation, and other similar costs, are expensed in the periods in which the costs are incurred and included in loss from operations in the condensed consolidated financial statements. The results of operations of the acquired business are included in the condensed consolidated financial statements from the acquisition date.

 

In November 2014, goodwill and intangible assets for in-process research and development werewas recorded in connection with the acquisition of RFS Pharma, and have represented a series of awarded patents, filed patent applications and an in-process research programsprogram acquired related to Hepatitis C compound development.

 

We evaluate indefinite-lived intangible assets and goodwill for impairment annually, as of November 30, or more frequently when events or circumstances indicate that impairment may have occurred. As part of the impairment evaluation, we may elect to perform an assessment of qualitative factors. If this qualitative assessment indicates that it is more likely than not that the fair value of the indefinite-lived intangible asset or the reporting unit (for goodwill) is less than its carrying value, we then would proceed with the quantitative impairment test to compare the fair value to the carrying value and record an impairment charge if the carrying value exceeds the fair value.

 

Fair value is typically estimated using an income approach based on the present value of future discounted cash flows. The significant estimates in the discounted cash flow model primarily include the discount rate, and rates of future revenue and expense growth and/or profitability of the acquired assets. In performing the impairment test, the Company considered, among other factors, the Company’s intention for future use of acquired assets, analyses of historical financial performance and estimates of future performance of Cocrystal’s product candidates.

 

In-process research and development assets are accounted for as indefinite-lived intangible assets and maintained on the balance sheet until either the underlying project is completed, or the asset becomes impaired. If the project is completed, the carrying value of the related intangible assets are amortized to cost of sales over the remaining estimated life of the asset(s), beginning in the period in which the project is completed. If the intangible asset becomes impaired or the related project is abandoned, the carrying value of the underlying intangible asset is written down to its fair value and an impairment charge is recorded in the period in which the impairment occurs and included in operating expenses under research and development within the relative condensed consolidated statement of operations.

The Company has a lead compound, CC-31244, for its Hepatitis C program, which was created at the Company’s labs in Bothell, Washington, and not part of the acquisition from RFS Pharma. In 2016, the Company initiated and completed a Phase 1A trial with compound CC-31244 and began a Phase 1B trial with CC-31244 that was completed in 2017. In 2018, the Company began a Phase 2A clinical trial with CC-31244 and recently released interim results in January 2019. In late 2018, the Company concluded that given the success of CC-31244 in clinical trials, the Hepatitis C program would move forward solely with CC-31244 without any of the compounds acquired from RFS Pharma. As part of this decision, the Company abandoned all remaining in process research and development intangible assets recognized by the Company and thereafter, terminated its license with Emory University on December 6, 2018. This resulted in a $53,905,000 impairment in the fourth quarter of 2018. At June 30, 2019 and December 31, 2018, there was no in-process research and development on the Company’s condensed consolidated balance sheets.

F-9F-6

 

 

At June 30, 2019 and DecemberMarch 31, 2018,2020, the Company had goodwill of $65,195,000 included$19,092,000. The Company completed its annual impairment test in November 2019, and at that time determined the fair value of its reporting unit, under both the Company’s Nasdaq market capitalization and an income approach analysis; both methods were less than the carrying value as of December 31, 2019; therefore, management considered goodwill to be impaired. This resulted in a $46,103,000 impairment in 2019.

Based on management’s assessment at March 31, 2020, no further impairment of Goodwill is required.

Long-Lived Assets

The Company regularly reviews the carrying value and estimated lives of its long-lived assets, including property and equipment, to determine whether indicators of impairment may exist which warrant adjustments to carrying values or estimated useful lives. The determinants used for this evaluation include management’s estimate of the asset’s ability to generate positive income from operations and positive cash flow in future periods as well as the strategic significance of the assets to the Company’s business objective. Should an impairment exist, the impairment loss would be measured based on the Company’s condensed consolidated balance sheets.excess of the carrying amount over the asset’s fair value.

Research and Development Expenses

All research and development costs are expensed as incurred.

 

Revenue Recognition

The Company recognizes revenue from research and development arrangements and grant income.arrangements. In accordance with Accounting Standards Codification (“ASC”) Topic 606–Revenue from Contracts with Customers (“Topic 606”), revenue is recognized when a customer obtains control of promised goods or services. The amount of revenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for these goods and services.

 

In November 2018, the FASB issued ASU 2018-18,Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606. This ASU provides guidance on whether certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. Accordingly, this amendment added unit of account guidance in Topic 606 when an entity is assessing whether the collaborative arrangement, or a part of the arrangement, is within the scope of Topic 606. In addition, the amendment provides certain guidance on presenting the collaborative arrangement transaction together with Topic 606. The Company adopted ASU 2018-18, effective in the fourth quarter of 2018 with no impact on our consolidated financial statements and related footnote disclosures.

On January 2, 2019, the Company entered into an Exclusive License and Research Collaboration Agreement (the “Collaboration Agreement”) with Merck Sharp & Dohme Corp. (“Merck”) to discover and develop certain proprietary influenza A/B antiviral agents. Under the terms of the Collaboration Agreement, Merck will fund research and development for the program, including clinical development, and will be responsible for worldwide commercialization of any products derived from the collaboration. As a result of this agreement, the

The Company recognized $4,368,000 in revenues as consideration in exchange for conveyance of intellectual property rights at the signing of the agreement and also receives revenues for reimbursement of research and development activities related to its influenza A/B program. Per the Collaboration Agreement, $4,000,000 was received as a milestone upfront payment, and the remaining amount recorded as a receivable in accordance with ASC Topic 606,Revenue from Contracts with Customers.The receivable is recognized as revenue ratably each quarter through the term of the agreement. Management reviews accounts receivable regularly to determine, using the specific identification method, if any receivable amounts will potentially be uncollectible and to estimate the amount of allowance for doubtful accounts necessary to reduce accounts receivable to its estimated net realizable value. Research and development expenses reimbursed by Merck and recognized as revenue for the three and six months ended June 30,March 31, 2020 and 2019 were $592,000$461,000 and $1,302,000, respectively, resulting in total revenue related to the Collaboration Agreement included in the condensed statements$5,078,000, respectively. As of operations for the six months ended June 30, 2019March 31, 2020, accounts receivable of $5,670,000.$644,000 was due from Merck.

 

Income Taxes

 

The Company accounts for income taxes under the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using enacted tax rates and laws that are expected to be in effect when the differences are expected to be recovered or settled. Realization of deferred tax assets is dependent upon future taxable income. A valuation allowance is recognized if it is more likely than not that some portion or all of a deferred tax asset will not be realized based on the weight of available evidence, including expected future earnings. The Company recognizes an uncertain tax position in its financial statements when it concludes that a tax position is more likely than not to be sustained upon examination based solely on its technical merits. Only after a tax position passes the first step of recognition will measurement be required. Under the measurement step, the tax benefit is measured as the largest amount of benefit that is more likely than not to be realized upon effective settlement. This is determined on a cumulative probability basis. The full impact of any change in recognition or measurement is reflected in the period in which such change occurs. The Company elects to accrue any interest or penalties related to income taxes as part of its income tax expense.

 

F-7

As of June 30, 2019,March 31, 2020, the Company assessed its income tax expense based on its projected future taxable income for the year ended December 31, 20192020 and therefore recorded no amount for income tax expense for the sixthree months ended June 30, 2019.March 31, 2020. In addition, the Company has significant deferred tax assets available to offset income tax expense due to net operating loss carry forwards which are currently subject to a full valuation allowance based on the Company’s assessment of future taxable income. Refer to our Annual Report on Form 10-K for the year ended December 31, 20182019 for more information.

 

Stock-Based Compensation

 

The Company recognizes compensation expense using a fair value-based method for costs related to stock-based payments, including stock options. The fair value of options awarded to employees is measured on the date of grant using the Black-Scholes option pricing model and is recognized as expense over the requisite service period on a straight-line basis.

 

Use of the Black-Scholes option pricing model requires the input of subjective assumptions including expected volatility, expected term, and a risk-free interest rate. The Company estimates volatility using a blend of its own historical stock price volatility as well as that of market comparable entities since the Company’s common stock has limited trading history and limited observable volatility of its own. The expected term of the options is estimated by using the Securities and Exchange Commission Staff Bulletin No. 107’sSimplified Method for Estimate Expected Term. The risk-free interest rate is estimated using comparable published federal funds rates.

F-10

Share Issuance Costs

The Company accounts for direct and incremental costs related to the issuance of its capital stock as a reduction in the proceeds from such issuances.

Common Stock Purchase Warrants and Other Derivative Financial Instruments

 

We classify as equity any contracts that require physical settlement or net-share settlement or provide us a choice of net-cash settlement or settlement in our own shares (physical settlement or net-share settlement) provided that such contracts are indexed to our own stock as defined in ASC 815-40,Contracts in Entity’s Own Equity. We classify as assets or liabilities any contracts that require net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside our control) or give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement). We assess classification of our common stock purchase warrants and other freestanding derivatives at each reporting date to determine whether a change in classification between assets and liabilities is required.

 

Net Income (Loss) per Share

The Company accounts for and discloses net income (loss) per common share in accordance with FASB ASC Topic 260,Earnings Per Share. Basic income (loss) per common share is computed by dividing income (loss) attributable to common stockholders by the weighted average number of common shares outstanding. Diluted net income (loss) per common share is computed by dividing net income (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 stock for all potential dilutive common shares outstanding. Potential common shares consist of shares issuable upon the exercise of stock options and warrants and the conversion of convertible notes payable.

The following table sets forth the computation of basic and diluted net income (loss) per common share (in thousands, except per share amounts) for the three months ended:

  March 31, 2020  March 31, 2019 
Numerator:        
Net income (loss) attributable to common stockholders $(1,990) $2,971 
Denominator:        
Weighted average number of shares outstanding, basic  41,662   30,337 
Adjustment for dilutive effects of warrants, outstanding and in-the-money  -   26 
Adjustment for dilutive effects of options, exercisable and in-the-money  -   8 
Weighted average number of common shares outstanding, diluted  41,662   30,371 
Net income (loss) per common share, basic $(0.05) $0.10 
Net income (loss) per common share, diluted $(0.05) $0.10 

F-8

The following table sets forth the number of potential common shares excluded from the calculations of net loss per diluted share because their inclusion would be anti-dilutive (in thousands):

  March 31, 
  2020  2019 
Outstanding options to purchase common stock  923   1,200 
Warrants to purchase common stock  243   217 
Notes payable convertible to common stock  -   - 
Total  1,166   1,417 

Recent Accounting Pronouncements

 

The following are new FASB Accounting Standards Updates (“ASUs”) that have been adopted by the Company as ofIn June 30, 2019:

In 2018, the Company adopted ASC Topic 606,Revenue from Contracts with Customers (“Topic 606”), which had no impact on our consolidated financial statements and related footnote disclosures as of and for the year ended December 31, 2018 included in our Annual Report on Form 10-K. In January 2019, the Company recognized collaboration revenue in accordance with Topic 606 as presented in the condensed consolidated statement of operations for the six months ended June 30, 2019.

In November 2018, the FASB issued ASU 2018-18,Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606. This ASU provides guidance on whether certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. Accordingly, this amendment added unit of account guidance in Topic 606 when an entity is assessing whether the collaborative arrangement, or a part of the arrangement, is within the scope of Topic 606. In addition, the amendment provides certain guidance on presenting the collaborative arrangement transaction together with Topic 606. ASU 2018-18 is effective for fiscal years beginning after December 15, 2019 and interim periods within those fiscal years and early adoption is permitted. This ASU is to be applied retrospectively to the date of initial application of Topic 606. The Company adopted ASU 2018-18, in the fourth quarter of 2018, which had no impact on our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2018, nor in the Company’s condensed consolidated financial statements as reported on this Form 10-Q for the six months ended June 30, 2019.

In February 2016, the FASB issued ASU No. 2016-02,Leases, subsequently amended by ASU No. 2018-01, ASU No. 2018-102016-13, Credit Losses - Measurement of Credit Losses on Financial Instruments (“ASC 326”). The standard significantly changes how entities will measure credit losses for most financial assets, including accounts and ASU No. 2018-11 (collectively, “ASC 842”),notes receivables. The standard will replace today’s “incurred loss” approach with an “expected loss” model, under which requires lessees tocompanies will recognize most leasesallowances based on their balance sheetsexpected rather than incurred losses. Entities will apply the standard’s provisions as a right-of-use (“ROU”) asset with a corresponding lease liability. Additional qualitative and quantitative disclosures are also required. The Company adopted the standard effective January 1, 2019 using the cumulative-effect adjustment transition method, which applies the provisionsto retained earnings as of the standard atbeginning of the effective date without adjustingfirst reporting period in which the comparative periods presented. The Company adopted the following practical expedients and elected the following accounting policies related to this standard update, a.) the option to not reassess prior conclusions related to the identification, classification and accounting for initial direct costs for leases that commenced prior to January 1, 2019, b.) short-term lease accounting policy election allowing lessees to not recognize ROU assets and liabilities for leases with a term of 12 months or less, and c.) the option to not separate lease and non-lease components for certain equipment lease asset categories. Adoption of ASC 842 resulted in the initial recognition of operating lease right-of-use assets and corresponding lease liabilities of approximately $833,000 on the Company’s consolidated balance sheet. The Company’s accounting for finance leases (previously referred to as capital leases under ASC 840) remained substantially unchanged. The standard did not materially impact operating results or liquidity. Disclosures related to the amount, timing and uncertainty of cash flows arising from leases are included in Note 12 – Commitments and Contingencies.

The following are new FASB Accounting Standards Updates that have not been adopted by the Company as of June 30, 2019, and contain detail regarding the effective dates:

In August 2018, the FASB issued ASU 2018-13,Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement. This ASU eliminates, adds and modifies certain disclosure requirements for fair value measurements as part of its disclosure framework project.guidance is effective. The standard is effective for all entities for financial statements issued for fiscal yearsinterim and annual reporting periods beginning after December 15, 2019,2019. The adoption of ASU 2016-13 is not expected to have a material impact on the Company’s financial position, results of operations, and interim periods within those fiscal years. Early adoption is permitted. The Company is currently assessing this ASU and has not yet determined the impact ASU 2018-13 may have on its condensed consolidated financial statements.

F-11

cash flows.

 

Other recent authoritative guidance issued by the FASB (including technical corrections to the ASC), the American Institute of Certified Public Accountants, and the Securities and Exchange Commission (“SEC”) did not, or are not expected to, have a material impact on the Company’s condensed consolidated financial statements and related disclosures.

 

3.Property and Equipment

 

Property and equipment are recorded at cost and depreciated over the estimated useful lives of the underlying assets (three to five years) using the straight-line method. As of June 30, 2019March 31, 2020, and December 31, 2018,2019, property and equipment consists of (in thousands):

 

 June 30, 2019 December 31, 2018  March 31, 2020 December 31, 2019 
Lab equipment (excluding equipment under finance leases) $960  $945  $1,138  $1,073 
Finance lease right-of-use lab equipment obtained in exchange for finance lease liabilities  347   347   347   347 
Computer and office equipment  89   75   120   92 
Total property and equipment  1,396   1,367   1,605   1,512 
Less: accumulated depreciation and amortization  (1,028)  (983)  (1,111)  (1,081)
Property and equipment, net $368  $384  $494  $431 

 

Total depreciation and amortization expense was $22,000were $30,000 and $45,000$23,000 for the three and six months ended June 30,March 31, 2020 and 2019 respectively, which includes amortization expense of $18,000 and $35,000 related to finance lease right-of-use lab equipment, respectively. Total depreciation and amortization expense were $14,000 and $29,000$17,000 for the three and six months ended June 30, 2018, respectively, and included no amortization expense for finance lease right-of-use assets.both years. For additional finance leases information, refer to Note 129 – Commitments and Contingencies.

 

4. Mortgage Note Receivable

In June 2014, the Company acquired a mortgage note from a bank for approximately $2,626,000 which was collateralized by, among other things, the underlying real estate and related improvements. The property subject to the mortgage was owned by an entity managed by Daniel Fisher and his affiliate, 580 Garcia Properties LLC (the primary obligor of the note). The mortgage note had an original maturity date of August 1, 2032 and bore an interest rate of 7.24%.

Shortly thereafter in 2014, Daniel Fisher and his affiliate, 580 Garcia Properties LLC (the primary obligor of the note), brought multiple lawsuits against the Company involving its predecessors and subsidiaries. The lawsuits were later settled and the complaints dismissed, without the Company making any payments to either Mr. Fisher or 580 Garcia Properties LLC. At the time of the note’s acquisition, 580 Garcia Properties LLC was delinquent in its obligation to make monthly payments. In December 2015, the Company proceeded in accordance with rights of a secured real estate creditor under California law, to initiate private foreclosure proceedings. During 2017, the court enjoined the Company from proceeding with the foreclosure sale pending further developments in the litigation.

In February 2018, the Company, Daniel Fisher, and 580 Garcia Properties LLC resolved all outstanding claims and disputes. As part of this settlement, the Company received a payment of $1,400,000 in exchange for the release of the mortgage note and deed of trust, resulting in a net gain of $106,000 for disposal of the mortgage note receivable reflected in the condensed consolidated statement of operations for the six months ended June 30, 2018.

5. Accounts Payable and Accrued Expenses

 

Accounts payable and accrued expenses consisted of the following (in thousands) as of:

 

 June 30, 2019 December 31, 2018  March 31, 2020 December 31, 2019 
Accounts payable $1,071  $616  $922  $1,511 
Accrued compensation  105   78   107   83 
Accrued other expenses  185   383   630   405 
Total accounts payable and accrued expenses $1,361  $1,077  $1,659  $1,999 

 

Accounts payable and accrued other expenses contain unpaid general and administrative expenses and costs related to research and development that have been billed and estimated unbilled, respectively, as of period-end.

 

F-12F-9

 

 

6. 5.Common Stock

 

As of June 30, 2019,March 31, 2020, the Company has authorized 100,000,000 shares of common stock, $.001$0.001 par value per share. The Company had 31,620,64652,140,699 and 29,938,36335,150,058 shares issued and outstanding as of June 30, 2019March 31, 2020 and December 31, 2018,2019, respectively.

The holders of common stock are entitled to one vote for each share of common stock held.

On January 18, 2018, the Company effected the Reverse Stock Split. See Note 1.

On May 3, 2018, the Company closed a public offering for gross proceeds and net proceeds of approximately $8,428,000 and $7,684,000, respectively. The Company sold 4,210,527 shares of common stock to the underwriter at approximately $1.767 per share which the underwriter sold to the public at $1.90 per share and issued the underwriter a warrant to purchase 84,211 shares of common stock at $2.09 per share over a four year period beginning October 27, 2018. On May 14, 2018 the underwriter exercised the option to purchase an additional 225,000 shares of common stock solely to cover overallotments. As of June 30, 2019, the underwriter has no further option to purchase additional shares.

On March 13, 2019, the Company closed a private placement of 1,602,283 shares of its common stock and received gross proceeds of $4,182,000, before deducting offering expenses and commissions, resulting in net proceeds of approximately $3,584,000.

 

On March 20, 2019, the Company by written notice suspended at-the-market sales of its common stock pursuant to the Equity Distribution Agreement, dated July 19, 2018 (the “Distribution Agreement”) by and among the Company, Ladenburg, Barrington, and AGP. In December 2018, Ladenburg terminated its role as a party.A.G.P./Alliance Global Partners (“AGP”). The Company also terminated the engagement of Barrington as a sales agent under the Distribution Agreement effective March 21, 2019. The Distribution Agreement remains in place with respect to AGP, subject to the suspension of sales discussed above until further notice is provided by the Company to AGP. In January 2019, we sold 80,000 shares of common stock under the Distribution Agreement and received net proceeds of approximately $344,000.

7. Convertible Notes Payable

The In October 2019, the Company accounts for convertible notes payable (when itand AGP amended and restated its Distribution Agreement to reduce the amount to be raised under the Distribution Agreement from $10,000,000 to $6,000,000 (inclusive of the $351,576 which has determined that the embedded conversion options should not be bifurcated from their host instruments) in accordance with ASC 470-20,Debt with Conversion and Other Optionsbeen raised to date).

 

On November 24, 2017January 29, 2020 the “Company and AGP further amended the Distribution Agreement to reduce the amount to be raised under the Agreement from $6,000,000 to $551,576 (inclusive of the $351,576 which has been raised to date).

On January 31, 2018,29, 2020, the Company entered into a securities purchase agreementsagreement with twocertain institutional investors, including the Company’s former Chairman of the Board, pursuant to which the company sold an aggregate principal of $1,000,000, and OPKO Health Inc., a related party, (collectively, the “Purchasers”), pursuant to which the Company sold an additional $1,000,000, of its 8% convertible notes (collectively, “Convertible Notes”) due on November 24, 2019agreed to sell and January 31, 2020, respectively.

The Convertible Notes, with accrued interest, were convertible into common stock for $8.10 per share at the option of the Purchasers. In the event the Company completedissue, in a financing in which the Company received at least $10,000,000 in gross proceeds and issued common stock or common stock equivalents to the investor (a “Financing”) or there is a change of control of the Company (or sale of substantially all of the Company’s assets), the outstanding principal amount of the Convertible Notes would automatically convert. Upon the closing of a Financing, the conversion price of the Convertible Notes shall be the lesser of (i) $8.10 per share or (ii) the price per share of the securities sold in the Financing.

The Company evaluated the embedded conversion features within the Convertible Notes under ASC 815-15 and ASC 815-40 to determine if they required bifurcation as a derivative instrument. The Company determined the embedded conversion features do not meet the definition of a derivative liability, and therefore, do not require bifurcation from the host instrument. In addition, the down-round provision under which the conversion price could be affected by future equity offerings, qualified for a scope exception from derivative accounting with the Company’s early adoption of ASU 2017-11,Simplifying Accounting for Certain Financial Instruments with Characteristics of Liabilities and Equity, during the year ended December 31, 2017. Since the embedded conversion features were not considered derivatives, the convertible notes were accounted for in accordance with ASC 470-20,Debt with Conversion and Other Options.

F-13

In May 2018, the Company completed a financing and issued a total of 4,435,527registered direct offering, 3,492,063 shares of common stock at $1.90a purchase price per share of $0.63 for aggregate gross proceeds to the Company of approximately $2.2 million, before deducting fees payable to the placement agent and net proceeds of $8,428,000 and $7,680,000, respectively. Althoughother estimated offering expenses payable by the total gross financing amount did not contractually effectuateCompany. The Company closed the conversion feature ofoffering on January 31, 2020.

On February 27, 2020, the Convertible Notes’Company entered into a securities purchase agreements,agreement with certain institutional investors, pursuant to which the Company allowed Purchasersagreed to convert the Convertible Notes to common stock at the $1.90 per share price of the May 2018 financing. All outstanding 8% convertible notes were converted tosell and issue, in a registered direct offering, 8,461,540 shares of common stock at a purchase price per share of $1.30 for aggregate gross proceeds to the Company of approximately $11.0 million, before deducting fees payable to the placement agent and other estimated offering expenses payable by the Company. The Company closed the offering on February 28, 2020.

On March 9, 2020, the Company entered into a securities purchase agreement with certain institutional investors, pursuant to which the Company agreed to sell and issue, in May 2018a registered direct offering, 5,037,038 shares of common stock at a purchase price per share of $1.35 for aggregate gross proceeds to the aggregate amountCompany of approximately $6.8 million, before deducting fees payable to the principalplacement agent, lock-up settlement fee and accrued interest of for approximately $2,062,000 as ofother estimated offering expenses payable by the date of conversion, for a total of 1,085,105 common shares issued.Company. The conversion was approved by disinterested members ofCompany closed the Company’s Board of Directors.offering on March 10, 2020.

 

8. 6.Stock Based Awards

 

Equity Incentive Plans

 

The Company adopted an equity incentive plan in 2007 (the “2007 Plan”) under which 1,786,635 shares of common stock had been reserved for issuance to employees and nonemployee directors and consultants of the Company. The Company no longer issues any awards under the 2007 Plan. Holders of outstanding incentive stock options granted under the 2007 Plan are eligible to purchase shares of the Company’s common stock at an exercise price equal to no less than the fair market value of such stock on the date of grant. The maximum term of options granted under the 2007 Plan was ten years.

 

The Company adopted a second equity incentive plan in 2015 (the “2015 Plan”) under which as amended, 5,000,0002,705,237 (including 1,038,570 initially transferred from the 2007 Plan) shares of common stock have been reserved for issuance to employees, and nonemployee directors and consultants of the Company. Recipients of incentive stock options granted under the 2015 Plan shall be eligible to purchase shares of the Company’s common stock at an exercise price equal to no less than the estimated fair market value of such stock on the date of grant. The maximum term of options granted under the 2015 Plan is ten years. As of June 30, 2019, 3,530,044March 31, 2020, 3,595,643 options remain available for future grants under the 2015 Plan.

F-10

 

The following table summarizes stock option transactions for the 2007 Plan and 2015 Plan, collectively, for the sixthree months ended June 30,March 31, 2020 and 2019 (in thousands, except per share amounts):

 

  Number of
Shares
Available
for Grant
  Total
Options
Outstanding
  Weighted
Average
Exercise
Price
  Aggregate
Intrinsic
Value
 
Balance at December 31, 2018  873   1,351  $5.73  $788 
Exercised  -   -   -   - 
Granted  2,295   -   -   - 
Cancelled  362   (362)  5.80   - 
Balance at June 30, 2019  3,530   989  $5.70  $- 

  Number of
Shares
Available
for Grant
  Total
Options
Outstanding
  Weighted
Average
Exercise
Price
  Aggregate
Intrinsic
Value
 
Balance at December 31, 2019  3,588   931  $4.14  $            - 
Exercised  -   -   -   - 
Granted  -   -   -   - 
Cancelled  8   (8)  2.94   - 
Balance at March 31, 2020  3,596   923   4.15   - 

 

On June 21, 2019, theThe Company held its annual shareholder meeting and voted to increase the number of shares reserved and available fordid not grant under the amended 2015 Plan by 2,294,762 shares of common stock. Noany options were granted during the sixthree months ended June 30, 2019,March 31, 2020, nor the sixthree months ended June 30, 2018.March 31, 2019.

 

The Company accounts for share-based awards to employees and nonemployees directors and consultants in accordance with the provisions of ASC 718,Compensation—Stock Compensation., and under the recently issued guidance following FASB’s pronouncement, ASU 2018-07,Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. Under ASC 718, and applicable updates adopted, share-based awards are valued at fair value on the date of grant and that fair value is recognized over the requisite service, or vesting, period. The Company values its equity awards using the Black-Scholes option pricing model, and accounts for forfeitures when they occur. For the three and six months ended June 30,March 31, 2020 and 2019, and 2018, equity-based compensation expense recorded was $107,000 and $33,000, and $146,000, and $105,000 and $212,000, respectively.

F-14

 

As of June 30, 2019,March 31, 2020, there was approximately $1,385,000$1,072,000 of total unrecognized compensation expense related to non-vested stock options that is expected to be recognized over a weighted average period of 1.81.4 years. For options granted and outstanding, there were 989,041923,065 options outstanding which were fully vested or expected to vest, with an aggregate intrinsic value of $0, a weighted average exercise price of $5.70,$4.15, and weighted average remaining contractual term of 8.07.84 years at June 30, 2019. Of those outstanding,March 31, 2020. For vested and exercisable options, outstanding shares totaled 174,041 options,413,690, with an aggregate intrinsic value of $0. These options had a weighted average exercise price of $19.39$5.84 per share and a weighted-average remaining contractual term of 2.47.1 years at June 30, 2019.March 31, 2020.

 

The aggregate intrinsic value of outstanding and exercisable options at June 30, 2019March 31, 2020 was calculated based on the closing price of the Company’s common stock as reported on The Nasdaq Capital Market on June 28, 2019March 31, 2020 of $2.35$0.71 per share less the exercise price of the options. The aggregate intrinsic value is calculated based on the positive difference between the closing fair market value of the Company’s common stock and the exercise price of the underlying options.

 

Common Stock Reserved for Future Issuance

 

The following table presents information concerning common stock available for future issuance (in thousands) as of:

 

 June 30, 2019 June 30, 2018  March 31, 2020 March 31, 2019 
Stock options issued and outstanding  989   426   923   1,208 
Shares authorized for future option grants  3,530   1,813   3,596   1,016 
Convertible notes  -   - 
Warrants outstanding  243   243   243   243 
Total  4,762   2,482   4,762   2,467 

F-11

 

9. 7.Warrants

 

The following is a summary of activity in the number of warrants outstanding to purchase the Company’s common stock for the sixthree months ended June 30, 2019March 31, 2020 (in thousands):

 

  

Warrants

Accounted for as:
Equity

  Warrants
Accounted for as:
Liabilities
    
  May 2018
Warrants
  

October 2013

Warrants

  

January 2014

Warrants

  Total 
             
Outstanding, December 31, 2018  84   26   133   243 
Exercised  -   -   -   - 
Granted  -   -   -   - 
Expired  -   -   -   - 
Outstanding, June 30, 2019  84   26   133   243 
Expiration date:  October 27, 2022  October 24, 2023   January 16, 2024     

F-15

The following is a summary of activity in the number of warrants outstanding to purchase the Company’s common stock for the six months ended June 30, 2018 (in thousands):

  

Warrants accounted for as:
Equity

  

Warrants accounted for as:
Liabilities

    
  May 2018
warrants
  April 2013
warrants
  October 2013
Series A
warrants
  January 2014
warrants
  Total 
                
Outstanding, December 31, 2017  -   50   26   133   209 
                     
Warrants Issued  84   -   -   -   84 
Warrants Expired  -   (50)  -   -   (50)
Warrants exercised  -   -   -   -   - 
Outstanding, June 30, 2018  84   -   26   133   243 
Expiration date  October 27, 2022   April 25, 2018  October 24, 2023  January 16, 2024    

Warrants consist of equity-classified warrants and warrants with the potential to be settled in cash, which are liability-classified warrants. As of June 30, 2019, and 2018, 159,164 warrants are accounted for as liabilities and 84,211 warrants are accounted for as equity.

Warrants Classified as Equity

Equity-classified warrants consist of stand-alone warrants with rights to buy shares of the Company at a pre-designated price on or before the date of expiration, irrespective of the market price. These purchase warrants are not attached to any debt or equity instruments, thus considered freestanding, and there are no circumstances under ASC 815 that require the warrants to be classified as liabilities or as derivatives. Thus, our May 2018 warrants will be classified as equity, and their value will be carried in the additional paid-in capital account in the stockholders’ equity section of the balance sheet.

These warrants were granted to the underwriters and investment brokers for services provided related to the Company’s May 2018 equity financing, and collectively grant the right to buy 84,211 shares of our stock at $2.09 per share for up to four years until expiration from the commencement date of October 27, 2018.

  

Warrants

Accounted for as:

Equity

  

Warrants

Accounted for as:

Liabilities

    
  

May 2018

Warrants

  October 2013 Warrants  January 2014 Warrants  Total 
Outstanding, December 31, 2019  84   26   133   243 
Exercised  -   -   -   - 
Granted  -   -   -   - 
Expired  -   -   -   - 
Outstanding, March 31, 2020  84   26   133   243 
Expiration date:  October 27, 2022   October 24, 2023   January 16, 2024     

 

Warrants Classified as Liabilities

 

Liability-classified warrants consist of warrants issued by Biozone in connection with equity financings in October 2013 and January 2014, which were assumed by the Company in connection with its merger with Biozone in January 2014. Warrants accounted for as liabilities have the potential to be settled in cash or are not indexed to the Company’s own stock.

 

The estimated fair value of outstanding warrants accounted for as liabilities is determined at each balance sheet date. Any decrease or increase in the estimated fair value of the warrant liability since the most recent balance sheet date is recorded in the condensed consolidated statement of operations as changes in fair value of derivative liabilities.

 

The fair value of the warrants classified as liabilities is estimated using the Black-Scholes option-pricing model with the following inputs as of June 30, 2019:March 31, 2020:

 

  October 2013
Warrants
  January 2014
Warrants
 
       
Strike price $15.00  $15.00 
Expected dividend yield  0.00%  0.00%
Contractual term (years)  4.3   4.6 
Cumulative volatility  87.62%  89.39%
Risk-free rate  1.74%  1.75%

F-16

  October 2013
Warrants
  January 2014
Warrants
 
       
Strike price $15.00  $15.00 
Expected dividend yield  0.0%  0.0%
Contractual term (years)  3.6   3.8 
Cumulative volatility  120.15%  118.41%
Risk-free rate  0.39%  0.41%
Value $0.20  $0.21 

 

The fair value of the warrants classified as liabilities is estimated using the Black-Scholes option-pricing model with the following inputs as of June 30, 2018:December 31, 2019:

 

  

October 2013

warrants

  

January 2014

warrants

 
       
Strike price $15.00  $15.00 
Expected dividend yield  0.00%  0.00%
Expected term (years)  5.32   5.55 
Cumulative volatility %  88.17%  88.59%
Risk-free rate %  2.74%  2.75%
  

October 2013

Warrants

  

January 2014

Warrants

 
       
Strike price $15.00  $15.00 
Expected dividend yield  0.00%  0.00%
Contractual term (years)  3.8   4.0 
Cumulative volatility  89.59%  90.58%
Risk-free rate  1.67%  1.68%
Value $0.04  $0.05 

 

As of the second quarter in 2019, the Company’s available historical market prices and price volatility exceeded the remaining contractual terms of outstanding warrants accounted for as liabilities. Therefore, as of June 30, 2019, theThe Company calculated the cumulative volatility percentage used in the Black-Scholes option-pricing model based on its own historical price volatility. In prior periods, including as of June 30, 2018, the Company estimatedestimates volatility using a blend of its own historical stock price volatility as well as that of market comparable entities since the Company’s common stock hadhas limited trading history and limited observable volatility of its own. The expected life assumption is based on the remaining contractual terms of the warrants. The risk-free rate is based on the zero-couponzero coupon rates in effect at the balance sheet date. The dividend yield used in the pricing model is zero, because the Company has no present intention to pay cash dividends.

 

10. 8.Licenses and Collaborations

 

Merck Sharp & Dohme Corp.

 

On January 2, 2019, the Company entered into an Exclusive License and Research Collaboration Agreement (the “Collaboration Agreement”) with Merck Sharp & Dohme Corp. (“Merck”) to discover and develop certain proprietary influenza A/B antiviral agents. Under the terms of the Collaboration Agreement, Merck will fundfunds research and development for the program, including clinical development, and will be responsible for worldwide commercialization of any products derived from the collaboration. Cocrystal received an upfront payment of $4,000,000 in 2019 and is eligible to receive payments related to designated development, regulatory and sales milestones with the potential to earn up to $156,000,000, as well as royalties on product sales. Merck can terminate the Collaboration Agreement at any time prior to the first commercial sale of the first product developed under the Collaboration Agreement, in its sole discretion, without cause.

 

As a result of this agreement, theThe Company recognized revenue of $4,368,000 as consideration$461,000 in exchange for conveyance of intellectual property rights at the time of the agreement signing in accordance with ASC Topic 606,Revenue from Contracts with Customers,which included the $4,000,000 milestone upfront payment, since received and recognized as collaboration revenues during the first quarter of 2019.

Research and development expenses related to our influenza A/B program which are reimbursable by Merck within 45 days of period-end under the terms of the Collaboration Agreement and recognized as collaboration revenue were $592,000 and $1,302,000 for the three and six months ended June 30, 2019, respectively. Total revenue of $5,670,000 included inon the condensed consolidated statement of operations and recorded the same amount in accounts receivable on the condensed consolidated balance sheet, for the sixthree months ended June 30, 2019 isand as of March 31, 2020, respectively, related to this Collaboration Agreement. Asinfluenza A/B program research and development expenses for the first quarter of June 30, 2019, $914,000 is due from Merck under these agreements.2020.

 

National Institute of Health

Cocrystal has two Public Health Biological Materials License Agreements with the National Institute of Health. The original License Agreements were dated August 31, 2010 and amended on November 6, 2013. The materials licensed are being used in Norovirus assays to screen potential antiviral agents in our library.

F-17F-12

 

 

11. Net Income (Loss) per ShareKansas State University Research Foundation

 

TheCocrystal entered into a License Agreement with Kansas State University Research Foundation (the “Foundation”) on February 18, 2020 to further develop certain proprietary broad-spectrum antiviral compounds for the treatment of Norovirus and Coronavirus infections.

Pursuant to the terms of the License Agreement, the Foundation granted the Company accounts foran exclusive royalty bearing license to practice under certain patent rights, under patent applications covering antivirals against coronaviruses, caliciviruses, and discloses net income (loss) per common share in accordance with FASB ASC Topic 260,Earnings Per Share. Basic income (loss) per common share is computed by dividing income (loss) attributablepicornaviruses, and related know-how, including to common stockholders by the weighted average number of common shares outstanding. Diluted net income (loss) per common share is computed by dividing net income (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 stock for all potential dilutive common shares outstanding. Potential common shares consist of shares issuable upon the exercise of stock optionsmake and warrantssell therapeutic, diagnostic and the conversion of convertible notes payable.prophylactic products.

 

The following table sets forthCompany agreed to pay the computationFoundation a one-time non-refundable license initiation fee of basic$80,000 under the License Agreement, and diluted net income (loss) per common share (in thousands, except per share amounts) forannual license maintenance fees. The Company also agreed to make certain future milestone payments, dependent upon the six months ended:

  June 30, 2019  June 30, 2018 
Numerator:        
Net income (loss) attributable to common stockholders $1,456  $(2,897)
         
Denominator:        
Weighted average number of shares outstanding, basic  30,986   26,050 
Adjustment for dilutive effects of warrants, outstanding and in-the-money  20   - 
Adjustment for dilutive effects of options, exercisable and in-the-money  -   - 
Weighted average number of common shares outstanding, diluted  31,006   26,050 
         
Net income (loss) per common share, basic $0.05  $(0.11)
Net income (loss) per common share, diluted $0.05  $(0.11)

The following table sets forthprogress of clinical trials, regulatory approvals, and initiation of commercial sales in the number of potential common shares excluded fromUnited States and certain countries outside the calculations of net loss per diluted share because their inclusion would be anti-dilutive (in thousands):United States. See Note 11, Subsequent Events with respect to another License Agreement with the foundation.

  

For the three months ended
June 30,

  For the six months ended
June 30,
 
  2019  2018  2019  2018 
Options to purchase common stock  988   426   988   426 
Warrants to purchase common stock  243   243   223   243 
Total  1,231   669   1,211   669 

 

12. 9.Commitments and Contingencies

Commitments

 

In the ordinary course of business, the Company enters into non-cancelable leases to purchase equipment and for its facilities, including related party leases (see Note 1310 – Transactions with Related Parties). As per Note 2, leasesLeases are accounted for as operating leases or finance leases, in accordance with ASC 842,Leases.

 

Operating Leases

 

The Company leases office space in Miami, Florida and laboratory space in Bothell, Washington under operating leases that expire on August 31, 2021 and January 31, 2024, respectively. The Company recently signed an amendment to the Bothell, Washington lease agreement by extending the lease term for a period of sixty months from February 2019 through January 2024. For operating leases, the weighted average discount rate is 8.0% and the weighted average remaining lease term is 4.24.5 years.

F-18

 

The following table summarizes the Company’s maturities of operating lease liabilities, by year and in aggregate, as of June 30, 2019March 31, 2020 (in thousands):

 

2019 (excluding the six months ended June 30, 2019) $111 
2020  225 
2020 (excluding the three months ended March 31, 2020) $170 
2021  213   213 
2022  178   178 
2023  183   183 
Thereafter  15   15 
Total operating lease payments  925   759 
Less: present value discount  (145)  (102)
    
Total operating lease liabilities $780  $657 

 

The operating lease liabilities summarized above do not include variable common area maintenance (CAM) charges, which are contractual liabilities under the Company’s Bothell, Washington lease. CAM charges for the Bothell, Washington facility are calculated annually based on actual common expenses for the building incurred by the lessor and proportionately billed to tenants based on leased square footage. For the sixthree months ended June 30,March 31, 2020 and 2019, approximately $20,000 and 2018, approximately $41,000 and $33,000$16,000 of variable lease expense (CAM) was included in general and administrative operating expenses on the condensed consolidated statements of operations, respectively.

 

The minimum lease payments above include the amounts that would be paid if the Company maintains its Bothell lease for the five-year term, starting February 2019. The Company has the right to terminate this lease after three years on January 31, 2022, by giving prior notice at least nine months before the early termination date and by paying a termination fee equal to the sum of unamortized leasing commissions and reimbursement for tenant improvements provided by the landlord amortized at 8.0% over the extended term.

 

On September 1, 2018, the Company entered into a lease agreement with a limited liability company controlled by Dr. Phillip Frost, a director and a principal shareholder of the Company (see Note 1310 – Transactions with Related Parties). The lease term is three years with an optional three-year extension. On an annualized basis, straight-line rent expense is approximately $58,000, including fixed and estimable fees and taxes.

 

The offices and laboratory spaces in Tucker, Georgia were leased from a limited liability company owned by one of Cocrystal’s former directors, Dr. Raymond Schinazi and previously leased on a month to month basis (see Note 13 – Transactions with Related Parties). The Company closed its offices and laboratory in Tucker, Georgia, and the final lease-related payment was made in October 2018.

F-13

 

As of June 30, 2019, right-of-use assets obtained in exchange for operating lease liabilities and amortization expense recognized for operating leases was $833,000 and $72,000, respectively. For the sixthree months ended June 30,March 31, 2020 and 2019, and 2018, operating lease expense, excluding short-term leases, finance leases and CAM charges, totaled approximately $100,000$44,000 and $83,000,$43,000, respectively. Additionally, the Company recognized short-term operating lease expense of $12,000 during the six months ended June 30, 2019, and cash paid for amounts included in the measurement of lease liabilities for operating leases as operating cash out flows in the same period.

 

Finance Leases

 

In November 2018, the Company entered into two lease agreements to acquire lab equipment with 18 monthly payments of $18,000 payable through May 27, 2020 and 36 monthly payments of $1,000 payable through November 21, 2021, respectively. For finance leases, the weighted average discount rate is 8.0% and the weighted average remaining lease term is 1.11.7 years.

 

The following table summarizes the Company’s maturities of finance lease liabilities, by year and in aggregate, as of June 30, 2019March 31, 2020 (in thousands):

 

2019 (excluding the six months ended June 30, 2019) $116 
2020  106 
2021  15 
Total finance lease payments  237 
Less: present value discount  (12)
Total finance lease liabilities $225 

F-19

2020 (excluding the three months ended March 31, 2020) $48 
2021  15 
Total finance lease payments  63 
Less: present value discount  (3) 
Total finance lease liabilities $60 

 

The leased lab equipment is depreciable over five years and is presented net of accumulated depreciation on the condensed consolidated balance sheets under property and equipment. As of June 30, 2019,March 31, 2020, total right-of-use lab equipment and accumulated depreciation recognized under finance leases is $347,000 and $41,000,$93,000, respectively, and depreciation expense for the sixthree months ended June 30, 2019March 31, 2020 was $35,000.$17,000. As of December 31, 2018,2019, total right-of-use assets lab equipment exchanged for finance lease liabilities was $347,000 and accumulated depreciation for lab equipment under finance leases was $6,000.$76,000.

 

At June 30,March 31, 2020, the aggregate outstanding balance of finance lease liabilities, current and long-term, is $63,000 and the Company expects to pay future interest charges of $3,000 over the remaining finance lease terms. For the three months ended March 31, 2020, the Company paid $57,000 and $2,000 in principal and interest, respectively, totaling financing cash out flows of $57,000, net of interest expense, for amount included in the measurement of lease liabilities for finance leases. At December 31, 2019, the aggregate outstanding balance of finance lease liabilities, current and long-term, is $225,000was $117,000 and the Company expects to pay future interest charges of $12,000$4,000 over the remaining finance lease terms. For the sixthree months ended June 30,March 31, 2019, the Company paid $106,000$52,000 and $11,000$6,000 in principal and interest, respectively, totaling financing cash out flows of $117,000$52,000, net of interest expense, for amountsamount included in the measurement of lease liabilities for finance leases and added back to net income the $11,000 of interest expense under cash flows from operating activities. The Company had no leases considered to be finance leases as of June 30, 2018.leases.

 

Contingencies

 

From time to time, the Company is a party to, or otherwise involved in, legal proceedings arising in the normal course of business. As of the date of this report, except as described below, the Company is not aware of any proceedings, threatened or pending, against it which, if determined adversely, would have a material effect on its business, results of operations, cash flows or financial position.

On September 20, 2018, Anthony Pepe, individually and on behalf of a class, action lawsuit was filed with the United States District Court for the District of New Jersey a complaint against the Company, certain current and former executive officers and directors of the Company and the other defendants named therein for violation of Section 10(b) of the Exchange Act and Rule 10b-5 promulgated thereunder. Additionally, the complaint alleges that certain current and former executive officers of the Company violated Section 20(a) of the Exchange Act. The class consists of the persons and entities who purchased the Company’s common stock during the period from September 23, 2013 through September 7, 2018. The plaintiffPepe also alleges violation of other sections of the Exchange Act by the defendants named in the complaint other than the Company. Pepe seeks damages, pre-judgment and post-judgment interest, reasonable attorneys’ fees, expert fees and other costs. On June 25, 2019, the plaintiffs in the class action lawsuit filed an amended class action complaint.

 

On January 16, 2019, Ms. Susan Church, a stockholder of the Company, filed with the United States District Court for the Western District of Washington a derivative suit against certain current and former executive officers and directors of the Company alleging breach of fiduciary duties, unjust enrichment, waste of corporate assets, and violations of the rules governing proxy solicitation. Church seeks, among other things, money damages, disgorgement of profits from alleged wrongful conduct, including cash bonuses, pre-judgment and post-judgment interest, reasonable attorneys’ fees, expert fees and other costs. The attorneys have agreed

Liberty Insurance Underwriters Inc. filed suit against us in federal court in Delaware seeking a declaratory judgment that it is not liable to a stay of the derivative suit pending resolution ofdefend us in the class action.and derivative litigation. The insurance company also is claiming it is entitled to recover $1 million it advanced to us in connection with the SEC investigation. We have retained counsel to defend us which has filed an answer to the complaint.

 

On September 7, 2018, the SEC filed with the United States District Court for the Southern District of New York a complaint against Dr. Philip Frost, a director and principal stockholder of the Company, a trust Dr. Frost controls and OPKO Health, Inc., a stockholder of the Company, of which Dr. Frost is the Chief Executive Officer, as well as other defendants named therein. On January 10, 2019, the District Court entered final judgments against these defendants on their consent without admitting or denying the allegations set forth in the complaint. Dr. Frost was permanently enjoined from violating a certain anti-fraud provision of the Securities Act of 1933, future violations of Section 13(d) of the Exchange Act and Rule 13d-1(a) thereunder and participating in penny stock offerings subject to certain exceptions.

 

F-14

In November 2017, Lee Pederson, a former Biozone lawyer, filed a lawsuit in Minnesota against co-defendants the Company, Dr. Phillip Frost, OPKO Health, Inc. and Brian Keller for various allegations. On September 13, 2018, the United States District Court granted the Company and its co-defendants’ motion to dismiss Pederson’s amended complaint. On October 11, 2018, Pederson filed a notice of appeal with the United States Court of Appeals for the Eighth Circuit.

On July 8, 2019, Mr. Pederson filed a lawsuit in The plaintiff’s appeal was denied and the U.S. District Court in Minnesota against the Company, Dr. Frost and Mr. Daniel Fisher. See Note 4 for information on Mr. Fisher. While the Company, to its knowledge, has not been served, it has obtained a copy of the complaint. In his complaint, Pederson alleges tortious interference by the Company and Dr. Frost with the collaboration agreement between Mr. Pederson and Mr. Fisher. Mr. Pederson seeks damages in the amount of $800,000 or such other amount as may be determined at trial.

F-20

dismissal affirmed.

 

While the Company intends to defend itself vigorously from the claims in the aforementioned disputes, it is unable to predict the outcome of these legal proceedings. Any potential loss as a result of these legal proceedings cannot be reasonably estimated. As a result, the Company has not recorded a loss contingency for any of the aforementioned claims.

 

We were recently notified thatCOVID-19

Our administrative and finance activities are fully functional out of our insurance company has initially declinedMiami, Florida location and our research laboratory in Bothell, Washington remains open for essential operations while meeting COVID-19 quarantine challenges. Our scientists are also able to covercontinue working remotely and we remain committed to meeting our corporate and development milestones throughout the class action and related derivative action described above. The insurance company had previously delayed reimbursing our legal fees related to the SEC subpoena we received in 2015 requesting information, but ultimately paid us that sum and never declined coverage.year. We have retained specialized insurance legal counsel to analyzeexperienced delays in our supply chain and strategize our options. While we cannot quantifywith service partners as a result of the amountCOVID-19 pandemic. Also because of litigation costs, they are likely to bethe unknown impact from the COVID-19 pandemic, it may have unanticipated material as would be any adverse judgment or settlement amount.effects on us in a number of ways including:

If our scientists and other personnel (or their family members) are infected with the virus, it may hamper our ability to engage in ongoing research activities;
Similarly, we rely on third parties who can be similarly impacted;
If these third parties are affected by COVID-19, they may focus on other activities which they may devote their limited time to other priorities rather than to our joint research;
We may experience a shortage of laboratory materials which would impact our research activities;
As a result of the continuing impact of the virus, we may fail to get access to third party laboratories which would impact our research activities; and
We may sustain problems due to the serious short-term and possible longer term serious economic disruptions as our economy faces unprecedented uncertainty.

 

13. 10.Transactions with Related Parties

Beginning November 2014 to October 2018, the Company leased its Tucker, Georgia facility from a limited liability company owned by one of Cocrystal’s former directors and principal shareholder, Dr. Raymond Schinazi. As of October 2018, the Company cancelled the leasing arrangement and closed its office and research lab in Tucker, Georgia. Total rent and other expenses paid in connection with this lease were $0 and $26,000 for the six months ended June 30, 2019 and 2018, respectively.

 

In September 2018, the Company leased administrative offices from a limited liability company owned by one of the Company’s directors and principal shareholder, Dr. Phillip Frost. The operating lease term is three years with an optional three-year extension. On an annualized basis, straight-line lease expense, including taxes and fees, for this location is approximately $58,000. In September 2018, the Company paid a lease deposit of $4,000 and total amounts paid in connection with this operating lease were $28,000$14,000 and $0$14,000 for the sixthree months ended June 30,March 31, 2020 and 2019, and 2018, respectively.

 

As further explained in Note 7 – Convertible Notes Payable, on November 24, 2017, the Company entered into a securities purchase agreement with a company significantly owned by the Company’s former Chairman of the Board and principal shareholder, Dr. Schinazi, pursuant to which the Company sold a principal amount of $500,000 of 8% convertible notes due November 24, 2019. On January 31, 2018, the Company entered into a securities purchase agreement with OPKO Health, Inc. (the “Purchaser”), a Company affiliated with Dr. Frost, pursuant to which the Company borrowed $1,000,000 from the Purchaser in exchange for issuing the Purchaser an 8% convertible note due January 31, 2020.

All 8% convertible notes, including accrued interest, were converted to common stock shares in May 2018 at $1.90 per share. Dr. Schinazi’s affiliated Company received 273,367 shares for its 8% convertible notes balance of approximately $519,000, and OPKO Health, Inc., affiliated with Dr. Frost, received 538,544 shares for its 8% convertible notes balance of approximately $1,023,000 upon conversion. In the condensed consolidated balance sheets, as of June 30, 2019 and December 31, 2018, no amounts remain in convertible notes payable due to related parties.

14. 11.Subsequent Events

 

Kansas State University Research Foundation

On April 19, 2020, the Company entered into a second License Agreement with the Foundation in addition to the License Agreement entered into in February 2020.

Pursuant to the terms of the second License Agreement, the Foundation granted the Company an exclusive royalty bearing license to practice under certain patent rights under patent applications covering antivirals against coronaviruses, caliciviruses, and picornaviruses, and related know-how, including to make and sell therapeutic, diagnostic and prophylactic products.

The Company has evaluated subsequent events throughagreed to pay the filingFoundation a one-time non-refundable license initiation fee of this Quarterly Report on Form 10-Q$110,000 and determined that there have been no events that have occurred that would require adjustmentsannual license maintenance fees. The Company also agreed to our disclosuresmake certain future milestone payments, dependent upon the progress of clinical trials, regulatory approvals, and initiation of commercial sales in the condensed consolidated financial statementsUnited States and certain countries outside the United States. (refer to Note 8 – Licenses and Collaborations).

Directors.

On April 15, 2020, the Board elected Dr. Roger Kornberg, Chairman of the Company’s Scientific Advisory Board, as a director to fill the vacancy on the Board, effective immediately following Dr. Jane Hsiao’s resignation. Dr. Kornberg was also appointed a member of the Compensation Committee and the Corporate Governance and Nominating Committee of the Board. Dr. Kornberg, a Nobel Laureate, will also continue as Chairman of the Company’s Scientific Advisory Board.

 

F-21F-15

 

 

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

 

Overview

 

Cocrystal Pharma, Inc. (the “Company” or “Cocrystal”) is a clinical stage biotechnology company seeking to discover and develop novel antiviral therapeutics as treatments for serious and/or chronic viral diseases. We employ unique structure-based technologies and Nobel Prize winning expertise to create first- and best-in-class antiviral drugs. These technologies are designed to efficiently deliver small molecule therapeutics that are safe, effective and convenient to administer. We have identified promising preclinical and early clinical stage antiviral compounds for unmet medical needs including influenza virus,Influenza Virus, Coronavirus, Hepatitis C virus (“HCV”), and norovirusNorovirus infections.

Impact of COVID-19 Pandemic

COVID-19 is caused by a coronavirus called SARS-CoV-2. Coronaviruses are a large family of viruses that are common in people and many different species of animals, including camels, cattle, cats, and bats. Rarely, animal coronaviruses can infect people and then spread between people. This occurred with MERS-CoV and SARS-CoV, and now with the virus that causes COVID-19.

The consequences of the COVID-19 pandemic and the impact on the national and global economy continues to evolve and the full extent of the impact is uncertain as of the date of this filing.

 

Research and Development Update

 

During the sixthree months ended June 30, 2019,March 31, 2020, the Company focused its research and development efforts primarily in four areas:

Influenza

On January 2, 2019, the Company entered into an Exclusive License and Research Collaboration Agreement (the “Collaboration Agreement”) with Merck Sharp & Dohme Corp. (“Merck”) to discover and develop certain proprietary influenza A/B antiviral agents. See Note 8 – Licenses and Collaborations in the notes to the condensed consolidated financial statements under Item I, above, for more information. The collaboration has identified novel inhibitors effective against both strains A and B. During the three areas: (i) Hepatitis C, (ii) Influenzamonths ended March 31, 2020, the Company continued working with Merck under the Collaboration Agreement.

We have several preclinical candidates under development for the treatment of influenza infection. CC-42344, a novel PB2 inhibitor, has been selected as a preclinical lead. This candidate binds to a highly conserved PB2 site of influenza polymerase complex (PB1: PB2: PA) and (iii) Norovirus Infections.exhibits a novel mechanism of action. CC-42344 showed excellent antiviral activity against influenza A strains, including avian pandemic strains and Tamiflu resistant strains, and has favorable pharmacokinetic profiles. We are currently conducting additional preclinical IND enabling activities and plan to initiate a Phase 1 study during 2021.

Coronavirus

During the three months ended March 31, 2020, the Company initiated a coronavirus program targeting the SARS-CoV-2 virus that is responsible for the COVID-19 pandemic. There is currently no specific vaccine or antiviral treatment available for COVID-19.

The Company is currently advancing its Coronavirus program leveraging the rights to preclinical leads from its License Agreements with Kansas State University Research Foundation to further develop certain proprietary broad-spectrum antiviral compounds for the treatment of coronavirus infections (COVID-19). Cocrystal intends to pursue research and development of these antiviral compounds for coronavirus, including preclinical and clinical development. The Company’s recent additional License Agreement significantly expands and further advances its COVID-19 program by providing novel anti-coronavirus compounds for further development.

Weinitiated preclinical studies of COVID-19 inhibitors during the second quarter and plans to identify additional COVID-19 inhibitors utilizing its proprietary platform technology during the third quarter of this year. The Company anticipates the selection of its lead preclinical molecule in the fourth quarter of 2020.

3

 

Hepatitis C

 

CC-31244, our HCV Non-Nucleoside Polymerase Inhibitor (“NNI”), is a potential best-in-class pan-genotypic inhibitor of NS5B polymerase for the treatment of HCV infection. It has the potential to be an important component in an all-oral ultra-short HCV combination therapy. The Company filed an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) on February 28, 2018 and received notice from the FDA on March 29, 2018 that its IND was now open and the Company was cleared to initiate its Phase 2a clinical study evaluating CC-31244 for the treatment of HCV infected individuals.

 

In June 2018, the Company began enrollment in and initiation of patient dosing in its Phase 2a clinical study evaluating CC-31244 for the treatment of HCV infected individuals and completed the enrollment in September 2018. The Phase 2a open-label study was designed to evaluate the safety, tolerability and preliminary efficacy of CC-31244 in combination with Epclusa, an approved twelve-week HCV drug. Patients arewere treated with CC-31244 and Epclusa for two weeks and then Epclusa alone for an additional four weeks for a total of six weeks.

 

On January 22, 2019 the Company announced safety and preliminary efficacy data for the Phase 2a study. All subjects had completed the six-week treatment regimen. The treatment was well tolerated with no study discontinuations due to adverse events. Eight of 12 subjects achieved the primary efficacy endpoint of sustained virologic response at 12 weeks after completion of treatment (SVR12). SVR12 is defined as undetectable virus in blood 12 weeks after completion of treatment and is considered a virologic cure. The trial was conductedeight subjects that achieved SVR12 had significantly higher frequencies of terminally differentiated effector memory CD8+ T cells compared with the four that relapsed at the Institute of Human Virology, University of Maryland School of Medicineboth baseline and at end-of-6-week treatment. The trial and the final study report is expected during the second half of 2019.have been completed

 

In addition, in October 2018, the Company signed a Clinical Trial Agreement for an investigator-initiated study with the Humanity & Health Research Centre (“HHRC”) in Hong Kong, China. The Phase 2a study of CC-31244 for the treatment of HCV, which commenced in May 2019, is being sponsored and conducted by the Humanity & Health Research CentreDue to unrest in Hong Kong underand the guidance of Dr. George Lau, MBBS (HKU), M.D. (HKU), FRCP (Edin, Lond), FHKAM (Med), FHKCP, FAASLD, Chairman of Humanity and Health Medical Centre, Hong Kong. The Companycoronavirus pandemic, the clinical trial agreement has provided CC-31244 for use in the Phase 2a study. The Phase 2a open-label study will evaluate the safety, tolerability and preliminary efficacy of Cocrystal’s CC-31244 in combination with Sofosbuvir and Daclatasvir with or without a protease inhibitor, for the treatment of hepatitis C.

In December 2018, the Company voluntarilybeen terminated a license agreement with Emory University covering the patents and patent applications for HCV inhibitors, which are not essential to our HCV program.effective March 24, 2020.

 

The Company is in partnership discussions for further clinical development of CC-31244.

Influenza

We have several preclinical candidates under development for the treatment of influenza infection. CC-42344, a novel PB2 inhibitor, has been selected as a preclinical lead. This candidate binds to a highly conserved PB2 site of influenza polymerase complex (PB1: PB2: PA) and exhibits a novel mechanism of action. CC-42344 showed excellent antiviral activity against influenza A strains, including avian pandemic strains and Tamiflu resistant strains, and has favorable pharmacokinetic profiles. We are currently conducting additional preclinical IND enabling studies and plan to initiate a Phase 1 study during 2020.

3

On January 2, 2019, the Company entered into an Exclusive License and Research Collaboration Agreement (the “Collaboration Agreement”) with Merck Sharp & Dohme Corp. (“Merck”) to discover and develop certain proprietary influenza A/B antiviral agents. Under the terms of the Collaboration Agreement, Merck is funding research and development for the program, including clinical development, and will be responsible for worldwide commercialization of any products derived from the collaboration. See Note 10 – Licenses and Collaborations in the notes to the condensed consolidated financial statements under Item I, above, for more information. The Company has identified novel inhibitors effective against both strains A and B that are in the preclinical stage. Several of these have potencies approaching single digit nanomolar.

 

Norovirus Infections

 

We continue to identify and develop non-nucleoside polymerase inhibitors using the Company’s proprietary structure-based drug design technology platform. Cocrystal recently entered into a License Agreement with the Kansas State University Research Foundation to further develop certain proprietary broad-spectrum antiviral compounds for humans to treat Norovirus and Coronavirus infections. Preclinical activities for our Norovirus program are currently under way. The Company expects to complete its proof-of-concept animal model study in the fourth quarter of 2020.

 

Results of Operations for the Three and Six Months Ended June 30, 2019March 31, 2020 compared to the Three and Six Months Ended June 30, 2018March 31, 2019

 

RevenuesRevenue

Collaboration revenueRevenue recorded for the three and six months ended June 30, 2019March 31, 2020 was $592,000 and $5,670,000, respectively,$461,000, compared with $0$5,078,000 for the three and six months ended June 30, 2018.March 31, 2019. The revenue for the three months ended March 31, 2019 revenue is from an initial license payment and program services and expense reimbursements receivedincluded $4,368,000 as consideration in exchange for research and development costs associated with our influenza A/B program in accordance withconveyance of intellectual property rights at the signing of the Merck Collaboration Agreement executed on January 2, 2019. Our expenseCurrently, reimbursement was higher duringof research and development expenses under the three months ended March 31, 2019 compared to the three months ended June 30, 2019 due in part to the transferCollaboration Agreement is our only source of influenza A/B program technology from our third-party vendors to Merck as part of the Merck Collaboration Agreement. As the result, our influenza A/B program expenses decreased during the three and six months ended June 30, 2019 compared to the prior year periods. See Note 10 within the condensed consolidated financial statements for more information.revenue.

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Research and Development Expense

 

Research and development expense consistsconsist primarily of compensation-related costs for our employees dedicated to research and development activities and for our Scientific Advisory Board members, as well as lab supplies, lab services, and facilities and equipment costs.costs related to our research and development programs. During the first quarter of 2020, we initiated a Coronavirus program targeting the SARS-CoV-2 virus that is responsible for the COVID-19 pandemic. There is currently no specific vaccine or antiviral treatment available for COVID-19.

 

Total research and development expenses for the three months ended June 30,March 31, 2020 and 2019 were $1,091,000, remaining comparable to expenses$1,283,000 and $878,000, respectively. The increase of $1,119,000 for the three months ended June 30, 2018. Total research$405,000 was primarily due increases in COVID-19 and development expenses for the six months ended June 30, 2019 were $1,969,000, remaining comparable to expenses of $1,997,000 for the six months ended June 30, 2018. For the six months ended June 30, 2019, Merck reimbursed us for certain research and development expenses related to our influenza A/B program in accordance with the Collaboration Agreement and the reimbursement is included in revenues, as discussed above.Influenza programs.

 

General and Administrative Expense

 

General and administrative expense includes compensation-related costs for our employees dedicated to general and administrative activities, legal fees, audit and tax fees, consultants and professional services, and general corporate expenses.

 

General and administrative expenses were approximately $1,051,000 for the three months ended June 30,March 31, 2020 and 2019 compared with $1,013,000 for the six months ended June 30, 2018.were approximately $1,139,000 and $1,323,000, respectively. The increasedecrease of $38,000$184,000 was primarily due to increaseddecreased audit related fees, and legal services that included contracts and litigation related matters.

General and administrative expenses were approximately $2,374,000 for the six months ended June 30,resulting from a change in our independent registered public accounting firm in April 2019, compared with $2,205,000 for the six months ended June 30, 2018. The increase of $169,000 was primarily due to increased audit related fees and legal services that included contracts, litigation and patent related matters.

 

Interest Expense, Net

 

Interest expense was $5,000 and $11,000 for the three months ended March 31, 2020 and six months ended June 30, 2019 respectively. Interest expense was $24,000were approximately $2,000 and $55,000 for the three months and six months ended June 30, 2018,$6,000, respectively. The interest amounts in 2019 represent interest incurred on finance leased lab equipment and 2018 interest incurred was on convertible notes which were converted to common stock in May 2018 (refer to Note 12 and Note 7, respectively, in the condensed consolidated financial statements).2019. Interest income was negligible for the three and six months ended June 30, 2019March 31, 2020 and 2018.2019.

 

Other Income/(Expense)

 

Change in the fair value of derivative liabilities for the six months ended June 30, 2019 was $140,000 compared to $281,000 for the six months ended June 30, 2018. In accordance with U.S. GAAP, we record other income or expense based upon the computed change in fair value of our outstanding warrants that are accounted for as liabilities. The fair value of our outstanding warrants is inversely related to the fair value of the underlying common stock; as such, an increase in the price of our common stock during a given period generally results in other expense. Conversely, a decrease in the price of our common stock generally results in other income, which is what occurred during both periods.

4

Also included as other income The change in the fair value of derivative liabilities for the sixthree months ended June 30, 2018 is a gain of $106,000 on the disposal of its mortgage note. The Company resolved all outstanding claimsMarch 31, 2020 and disputes with 580 Garcia Properties, LLC. In exchange, the Company received $1,400,000 on February 9, 2018 from a third party. At December 31, 2017, the mortgage note receivable balance2019 was $1,294,000 resulting in the aforementioned gain.$27,000 and $100,000, respectively.

 

Income Taxes

 

No income tax benefit or expense was recognized for the three and six months ended June 30, 2019.March 31, 2020. The Company’s effective income tax rate was 0.0% and 0.0% for the three-months ended March 31, 2020 and March 31, 2019, respectively. 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.

 

For the three and six months ended June 30, 2018, we recognized an income tax benefit of approximately $554,000 and $973,000, respectively, primarily due to the change in effective federal income tax rates (from 35% to 21%) used to calculate the Company’s deferred tax liability which related to acquired in-process research and development considered to be indefinite-lived intangible assets and totaled $12,609,000 as of June 30, 2018. The Company abandoned the underlying assets associated with in-process research and development (“IPR&D”) intangibles in the fourth quarter of 2018, which were then written off along with the Company’s associated deferred tax liability.

Net Income (Loss)

 

As a result of the above factors, the Company had net income of approximately $1,456,000 compared to a net loss of approximately $2,897,000 for the six months ended June 30, 2019 and 2018, respectively, and a net loss of approximately $1,515,000 and $1,343,000 for the three months ended June 30, 2019 and 2018, respectively.March 31, 2020, the Company had net loss of approximately $1,990,000 compared with a net income of approximately $2,971,000 for the same period in 2019.

 

Liquidity and Capital Resources

 

Net cash used by operating activities was $2,186,000 for the three months ended March 31, 2020 compared with net cash provided by operating activities was $990,000 for the six months ended June 30, 2019 compared to net cash used in operating activities of $4,171,000$2,018,000 for the same period in 2018.2019. This was primarily due to the revenue resulting$4,000,000 upfront payment from Merck at the signing of the Collaboration Agreement with Merck (refer to Note 10 – Licenses and Collaborations).in January 2019.

 

Net cash used for investing activities was approximately $29,000$93,000 for the sixthree months ended June 30, 2019March 31, 2020 compared to $1,395,000with $25,000 net cash provided by investing activitiesused for the same period in 2018.2019. For the sixthree months ended June 30,March 31, 2020 and 2019, net cash used for investing activities consisted primarily of capital spending for computers and lab equipment. For the six months ended June 30, 2018, net cash provided by investing activities primarily consisted of the proceeds from the sale of the mortgage note asset for $1,400,000.

 

For the six months ended June 30, 2019,Net cash provided by financing activities totaled $3,811,000. Our 2019 financing activities included approximately $3,928,000 net proceeds from$16,547,000 for the issuancethree months ended March 31, 2020 compared with $3,876,000 for the same period in 2019. This was primarily due to the sale of common stock reduced by payments of $117,000 made onin three registered direct offerings during the Company’s lease liabilities for financed lab equipment. Net cash provided by financing activities was $8,869,000 for the sixthree months ended June 30, 2018. Net cash provided by financing activities during the six months ended June 30, 2018 consisted of $7,684,000 net proceeds from the issuance of common stock, $1,000,000 in proceeds from the issuance of convertible notes, and $185,000 in proceeds from the exercise of stock options.

To date we have focused our efforts on research and development activities, including through collaborations with suitable partners. We have never been profitable on an annual basis, have no products approved for sale, have not generated any revenues to date from product sales, and has incurred significant operating losses and negative operating cash flows on an annual basis since inception.March 31, 2020.

 

5

 

 

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. Based oncosts. The Company had $21,686,000 cash on hand asMarch 31, 2020 and believes this is sufficient to maintain planned operations through 2021.

We have focused our efforts on research and development activities, including through collaborations with suitable partners. We have been profitable on a quarterly basis, but have never been profitable on an annual basis. We have no products approved for sale and have incurred operating losses and negative operating cash flows on an annual basis since inception.

The Company’s interim consolidated financial statements are prepared using generally accepted accounting principles in the United States of August 9, 2019 of approximately $7.2 million, the Company may not have the capitalAmerica applicable to finance its operations including any unforeseen expenses such as higher than anticipated legal costs and uninsured catastrophe to the Company operations for the next 12 months. The ability of the Company to continue as a going concern, is dependent onwhich contemplates the Company obtaining adequate capital to fund its operations until it becomes profitable. If the Company is unable to obtain adequate capital, it could be forced to cease operations or substantially curtail its drug development activities. The accompanying financial statements do not include any adjustments relating to the recoverability and classificationrealization of recorded asset amountsassets and the classificationsatisfaction of liabilities shouldin the Company be unable to continue as a going concern.

Historical Financingsnormal course of business.

 

Historically, public and private equity offerings have been our principal source of liquidity. During the three months ended March 31, 2020, the Company closed the following three registered direct offerings of its Common Stock.

On January 29, 2020, the Company entered into a Placement Agency Agreement with AGP, pursuant to which AGP agreed to serve as the placement agent in connection with the registered offering of 3,492,063 shares of Common Stock (the “Shares”) at a public offering price of $0.63 per share for aggregate gross proceeds to the Company of approximately $2.2 million, before deducting fees payable to the placement agent and other estimated offering expenses payable by the Company. In connection with the offering, the Company also entered into Securities Purchase Agreements with certain investors named therein, pursuant to which the Company agreed to issue the Shares directly to investors. The Company closed the offering on January 31, 2020.

 

On May 3, 2018,February 27, 2020, the Company closedentered into a publicsecurities purchase agreement with certain institutional investors, pursuant to which the Company agreed to sell and issue, in a registered direct offering, 8,461,540 shares of Common Stock at a purchase price per share of $1.30 for aggregate gross proceeds and net proceedsto the Company of approximately $8,428,000$11.0 million, before deducting fees payable to the placement agent and $7,684,000, respectively.other estimated offering expenses payable by the Company. The Company sold 4,210,527 shares of common stock toclosed the underwriter at approximately $1.767 per share which the underwriter sold to the public at $1.90 per share and issued the underwriter a warrant to purchase 84,211 shares of common stock at $2.09 per share over a four year period beginning October 27, 2018. On May 14, 2018, the underwriter exercised the option to purchase an additional 225,000 shares of common stock solely to cover overallotments. As of June 30, 2019, the underwriter has no further option to purchase additional shares.offering on February 28, 2020.

 

On March 13, 2019,9, 2020, the Company closedentered into a private placement of 1,602,283securities purchase agreement with certain institutional investors, pursuant to which the Company agreed to sell and issue, in a registered direct offering, 5,037,038 shares of its common stock and receivedCommon Stock at a purchase price per share of $1.35 for aggregate gross proceeds to the Company of $4,182,000,approximately $6.8 million, before deducting fees payable to the placement agent and other estimated offering expenses and commissions, and net proceeds were approximately $3,584,000.

On March 20, 2019, the Company by written notice suspended at-the-market sales of its common stock pursuant to the previously disclosed Equity Distribution Agreement, dated July 19, 2018 (the “Distribution Agreement”) by and among the Company, Ladenburg Thalmann & Co. Inc., Barrington Research Associates, Inc. (“Barrington”), and Alliance Global Partners (“AGP”). Previously, on December 14, 2018, the Company received notice from Ladenburg regarding the termination of its engagement as a sales agent under the Distribution Agreement. On March 20, 2019, the Company terminated Barrington’s engagement as a sales agent under the Distribution Agreement, effective March 21, 2019. The Distribution Agreement remains in place with respect to AGP, subject to the suspension of sales discussed above until further notice is providedpayable by the Company. The Company to AGP. In January 2019, we sold 80,000 shares of common stock underclosed the Distribution Agreement and received net proceeds of approximately $344,000.offering on March 10, 2020.

 

As the Company continues to incur losses, achieving profitability is dependent upon the successful development, approval and commercialization of its product candidates, and achieving a level of revenues adequate to support the Company’s cost structure. The Company may never achieve profitability, and unless and until it does, the Company will continue to need to raise additional capital. Management intends to fund future operations through additional private or public equity offerings and may seek additional capital through arrangements with strategic partners or from other sources. There can be no assurances, however, that additional funding will be available on terms acceptable to the Company, or at all. Anyall, and any equity financing may be very dilutive to existing shareholders.

 

Cautionary Note Regarding Forward-Looking Statements

 

This report includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the future progress of our Phase 2a open-label study in Hong Kong, the expected timing of our Phase 1 Influenza study, our continued future collaboration with Merckpotential under the Collaboration Agreement,Agreement; the expected progress of, and the anticipated timing of achieving the value-driving milestones in, our Influenza program, including the initiation of the Phase 1 study in 2021; the expected progress of, and the anticipated timing of achieving the value-driving milestones in, our coronavirus program, including identifying additional inhibitors using our proprietary platform technology in Q3 2020 and the selection of a preclinical lead molecule in Q4 2020; the expected progress of, and the anticipated timing of achieving the value-driving milestones in, our norovirus program, including completing the proof-of-concept animal model study in the fourth quarter of 2020; and future liquidity. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs.

 

6

 

 

The results anticipated by any or all of these forward-looking statements might not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include the risks arising from the impact of the COVID-19 pandemic on our Company, including its future effect on the U.S. and global economies, supply chain disruptions, our continued ability to proceed with our programs, receive necessary regulatory approvals and continue to rely on certain third parties, and on the national and global economy, risks arising from our reliance on continuedcontinuing collaboration with Merck under the availabilityCollaboration Agreement, the future results of products manufactured by third parties, the ability ofpreclinical and clinical research organizations to recruit subjects and complete studies, in a timely manner or at all, including as the result of civil unrest and political instability in Hong Kong, unanticipated events which adversely affect the timing and success of our regulatory filings, general risks arising from clinical trials, failure to develop products which are deemed safereceipt of regulatory approvals, development of effective treatments and/or vaccines by competitors, and effective and other issues which affect our ability to commercialize our product candidates, unexpected adverse events affecting our ability to raise capital, unanticipated litigationfind and other expenses and factors that affect the capital markets in general and early stage biotechnology companies in particular.enter into agreements with suitable collaboration partners. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2018.2019. We undertake no obligation to publicly update or revise any forward-looking statements, whether as the result of new information, future events or otherwise.

 

Critical Accounting Policies and Estimates

 

In our Annual Report on Form 10-K for the year ended December 31, 2018,2019, we disclosed our critical accounting policies and estimates upon which our financial statements are derived.

Accounting estimates.The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. 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 revenues and expenses during the reporting period. Actual results could differ significantly from these estimates

Goodwill.As of March 31, 2020, the Company had a goodwill of $19,092,000. Goodwill is tested at least annually for impairment or when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable, by assessing qualitative factors or performing a quantitative analysis in determining whether it is more. The Company’s last annual impairment assessment was on November 30, 2019.

Revenue recognition. Effective in the fourth quarter of 2018, we adopted Accounting Standards Codification (“ASC”) Topic 606–Revenue from Contracts with Customers.

Readers are encouraged to review these disclosures in the Company’s Annual Report on Form 10-K for the year ended December 31, 20182019 in conjunction with the review of this report.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not applicable.

 

ITEM 4. CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

OurWe carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, evaluatedof the effectiveness of our disclosure controls and procedures, (as such term isas defined in Rules 13a-15(e) and 15d-15(e) underof the Securities Exchange Act)Act of 1934 (the “Exchange Act”) as of June 30, 2019. We maintainthe end of the period covered by this report. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures that are designedas of March 31, 2020 were effective to provide reasonable assuranceensure that information required to be disclosed by us in our reports filedthat we file or submittedsubmit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’sSecurities and Exchange Commission’s rules and forms andforms.

Changes in Internal Control over Financial Reporting

There were no material changes in our internal controls over financial reporting or in other factors that such information is accumulated and communicatedcould materially affect, or are reasonably likely to affect, our management, including our principal executive officer and principalinternal controls over financial officer, as appropriate,reporting during the quarter ended March 31, 2020. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to allow for timely decisions regarding required disclosure. Our management recognizesfuture periods are subject to the risk that any controls andmay become inadequate because of changes in conditions, or that the degree of compliance with the policies or 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 such evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were not effective as of June 30, 2019.may deteriorate.

 

7

Changes in Internal Control Over Financial Reporting

With input and oversight from the Audit Committee, management is actively implementing a remediation plan to ensure that control deficiencies contributing to the material weaknesses were remediated such that these controls will operate effectively. We are taking, and expect to continue to take the following remediation actions:

(i) the implementation of additional review procedures designed to enhance the control owner’s execution of controls activities, including entity level controls, through the implementation of improved documentation standards evidencing execution of these controls, oversight, and training;

(ii) improvement of the control activities and procedures associated with the review of complex accounting areas, including proper segregation of duties and assigning personnel with the appropriate experience as preparers and reviewers over analyses relating to such accounting areas;

(iii) educating and re-training control owners regarding internal control processes to mitigate identified risks and maintaining adequate documentation to evidence the effective design and operation of such processes; and

(iv) implementing enhanced controls to monitor the effectiveness of the underlying business process controls that are dependent on the data and financial reports generated from the relevant information systems.

We believe that these actions, and the improvements we expect to achieve as a result, will effectively remediate the material weaknesses identified in 2018. However, the material weaknesses in our internal control over financial reporting will not be considered remediated until the remediated controls operate for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively. We expect that the remediation of these material weaknesses will be completed in 2019.

Other than noted above, there were no changes in internal control over financial reporting that occurred during the six months ended June 30, 2019, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

8

 

 

PART II — OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

From time to time, the Company is a party to, or otherwise involved in, legal proceedings arising in the normal course of business. During the reporting period, except as set forth below, there have been no material changes to the description of legal proceedings set forth in our Annual Report on Form 10-K for the year ended December 31, 2018 (the “Annual Report”). The following should be read in conjunction with the information provided in Part I, Item 3 of our Annual Report.

On January 16, 2019, Ms. Susan Church, a stockholder of the Company, filed with the United States District Court for the Western District of Washington a derivative suit against certain current and former executive officers and directors of the Company alleging breach of fiduciary duties, unjust enrichment, waste of corporate assets, and violations of the rules governing proxy solicitation. Church seeks, among other things, money damages, disgorgement of profits from alleged wrongful conduct, including cash bonuses, pre-judgment and post-judgment interest, reasonable attorneys’ fees, expert fees and other costs. The attorneys have agreed to stay this derivative suit pending resolution of the class action discussed below.

On September 20, 2018, a class action lawsuit was filed with the United States District Court for the District of New Jersey a complaint against the Company, certain current and former executive officers and directors of the Company and the other defendants named therein for violation of Section 10(b) of the Exchange Act and Rule 10b-5 promulgated thereunder. Additionally, the complaint alleges that certain current and former executive officers of the Company violated Section 20(a) of the Exchange Act. The class consists of the persons and entities who purchased the Company’s common stock during the period from September 23, 2013 through September 7, 2018. The plaintiffs seek damages, pre-judgment and post-judgment interest, reasonable attorneys’ fees, expert fees and other costs. On June 25, 2019, the plaintiffs in the class action lawsuit filed an amended class action complaint.

On July 8, 2019, Mr. Lee Pederson filed a lawsuit in the United States District Court for the District of Minnesota against the Company, Dr. Phillip Frost and Mr. Daniel Fisher. While the Company, to its knowledge, has not been served, it has obtained a copy of the complaint. In his complaint, Pederson alleges tortious interference by the Company and Dr. Frost with the collaboration agreement between Mr. Pederson and Mr. Fisher. Mr. Pederson seeks damages in the amount of $800,000 or such other amount as may be determined at trial.

2019.

 

ITEM 1.A RISK FACTORS

 

None.

The information presented below updates, and should be read in conjunction with, the risk factors and information disclosed in our Annual Report on Form 10-K for the year ended December 31, 2018.

Delays and disruptions in our clinical studies, including our Phase 2a Hepatitis C study in Hong Kong, due to political instability, civil unrest, or acts of terrorism could negatively impact our business and future prospects.

The Phase 2a study of CC-31244 for the treatment of HCV, which commenced in May 2019, is being sponsored and conducted by the Humanity & Health Research Centre in Hong Kong, China. Hong Kong has recently experienced a series of large-scale protests, which have grown increasingly violent since they first started in March 2019. The protests may disrupt the Phase 2a study. If the protests continue and/or escalate further, it could prevent the Humanity & Health Research Centre from completing the Phase 2a study in a timely manner or at all. If the Humanity & Health Research Centre fails to complete the Phase 2a study as the result of continuing civil unrest and political instability in Hong Kong, it could negatively affect our ability to advance negotiations with potential strategic collaboration partners for the development and commercialization of CC-31244, which in its turn would have a material adverse effect on our business and future prospects.

 

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

 

All recent sales of unregistered securities have been previously reported.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

None.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not Applicable.applicable.

 

ITEM 5. OTHER INFORMATION

 

None.

 

ITEM 6. EXHIBITS

 

The exhibits listed in the accompanying “Exhibit Index” are filed or incorporated by reference as part of this Form 10-Q.

 

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EXHIBIT INDEX

Exhibit   Incorporated by Reference 

Filed or

Furnished

No. Exhibit Description Form Date Number Herewith
3.1 Certificate of Incorporation, as amended 10-Q 8/9/18 3.1  
3.2 Bylaws 8-K 12/1/14 3.4  
10.1 Exclusive License and Research Collaboration Agreement between the Company and Merck Sharp & Dohme Corp., dated January 2, 2019* 10-K 4/1/19 10.12  
10.2 Amendment to Equity Distribution Agreement, dated March 20, 2019 8-K 3/26/19 10.1  
10.3 Securities Purchase Agreement, dated March 11, 2019 8-K 3/11/19 10.1  
10.4 Amendment, dated January 29, 2020, to the Amended and Restated Equity Distribution Agreement, dated October 2, 2019, between the Company and A.G.P./Alliance Global Partners 8-K 1/29/20 1.1  
10.5 Placement Agency Agreement, dated January 29, 2020, between the Company and A.G.P./Alliance Global Partners+ 8-K 1/31/20 1.1  
10.6 Form of Securities Purchase Agreement, dated January 29, 2020, among the Company and the purchasers named therein+ 8-K 1/31/20 10.1  
10.7 License Agreement, dated February 18, 2020, between the Company and Kansas State University Research Foundation*       Filed
10.8 Engagement letter dated February 26, 2020 by and between the Company and H.C. Wainwright & Co., LLC 8-K 3/4/20 10.2  
10.9 Form of Securities Purchase Agreement, dated February 27, 2020, by and between the Company and the purchasers named therein+ 8-K 3/4/20 10.1  
10.10 Form of Securities Purchase Agreement, dated March 9, 2020, by and between the Company and the purchasers named therein+ 8-K 3/13/20 10.1  
31.1 Certification of Principal Executive Officer (302)       Filed
31.2 Certification of Principal Financial Officer (302)       Filed
32.1 Certification of Principal Executive and Principal Financial Officer (906)       Furnished**
101.INS XBRL Instance Document       Filed
101.SCH XBRL Taxonomy Extension Schema Document       Filed
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document       Filed
101.DEF XBRL Taxonomy Extension Definition Linkbase Document       Filed
101.LAB XBRL Taxonomy Extension Label Linkbase Document       Filed
101.PRE XBRL Taxonomy Extension Presentation Linkbase Document       Filed

* Portions of this exhibit have been omitted as permitted by the rules of the SEC. The information excluded is both (i) not material and (ii) would be competitively harmful if publicly disclosed. The Company undertakes to submit a marked copy of this exhibit for review by the SEC staff, to the extent it has not been previously provided, and provide supplemental materials to the SEC staff promptly upon request.

** This exhibit is being furnished rather than filed and shall not be deemed incorporated by reference into any filing, in accordance with Item 601 of Regulation S-K.

+ Exhibits and/or schedules have been omitted. The Company hereby agrees to furnish to the SEC upon request any omitted information.

Copies of this report (including the financial statements) and any of the exhibits referred to above will be furnished at no cost to our shareholders who make a written request to our Corporate Secretary at Cocrystal Pharma, Inc., 4400 Biscayne Blvd, Suite 101, Miami, FL 33137.

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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.

 

 Cocrystal Pharma, Inc.
   
Dated: August 9, 2019May 13, 2020By:/s/ Gary Wilcox
  Gary Wilcox
  Chief Executive Officer
  (Principal Executive Officer)

 

Dated: August 9, 2019May 13, 2020By:/s/ James Martin
  James Martin
  Chief Financial Officer
  (Principal Financial Officer)

 

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EXHIBIT INDEX

Exhibit   Incorporated by Reference Filed or
Furnished
No. Exhibit Description Form Date Number Herewith
2.1 Agreement and Plan of Merger* 8-K 12/1/14 2.1  
3.1 Certificate of Incorporation, as amended 10-Q 8/9/18 3.1  
3.2 Bylaws 8-K 12/1/14 3.4  
10.1 Exclusive License and Research Collaboration Agreement between the Company and Merck Sharp & Dohme Corp., dated January 2, 2019** 10-K 4/1/19 10.12  
10.2 Amendment to Equity Distribution Agreement, dated March 20, 2019 8-K 3/26/19 10.1  
10.3 Form of Securities Purchase Agreement, dated March 11, 2019* 8-K 3/11/19 10.1  
31.1 Certification of Principal Executive Officer (302)       Filed
31.2 Certification of Principal Financial Officer (302)       Filed
32.1 Certification of Principal Executive and Principal Financial Officer (906)       Furnished***
101.INS XBRL Instance Document       Filed
101.SCH XBRL Taxonomy Extension Schema Document       Filed
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document       Filed
101.DEF XBRL Taxonomy Extension Definition Linkbase Document       Filed
101.LAB XBRL Taxonomy Extension Label Linkbase Document       Filed
101.PRE XBRL Taxonomy Extension Presentation Linkbase Document       Filed

* Certain exhibits and schedules have been omitted. The Company undertakes to furnish the omitted items to the SEC upon request.

** Confidential treatment has been granted with respect to certain portions of this exhibit. Omitted portions have been submitted separately to the SEC.

*** This exhibit is being furnished rather than filed and shall not be deemed incorporated by reference into any filing, in accordance with Item 601 of Regulation S-K.

Copies of this report (including the financial statements) and any of the exhibits referred to above will be furnished at no cost to our shareholders who make a written request to our Corporate Secretary at Cocrystal Pharma, Inc., 4400 Biscayne Blvd, Suite 101, Miami, FL 33137.

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