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 March 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 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 [  ]
       
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 May 13, 2020, the number of outstanding shares of the registrant’s common stock, par value $0.001 per share, was 52,140,699.

 

 

 

 

 

 

COCRYSTAL PHARMA, INC.

 

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

 

INDEX

 

Part I - FINANCIAL INFORMATION  
Item 1.  
Condensed Consolidated Balance Sheets F-1
Condensed Consolidated Statements of Operations F-2
Condensed Consolidated Statements of Stockholders’ Equity F-3
Condensed Consolidated Statements of Cash Flows F-4
Notes to the Condensed Consolidated Financial Statements F-5
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 3
Item 3. Quantitative and Qualitative Disclosures About Market Risk 7
Item 4. Controls and Procedures 7
Part II - OTHER INFORMATION  
Item 1. Legal Proceedings 8
Item 1.A. Risk Factors 8
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 8
Item 3. Defaults Upon Senior Securities 8
Item 4. Mine Safety Disclosures 8
Item 5. Other 8
Item 6. Exhibits 8
SIGNATURES 10

 

 

 

 

Part I – FINANCIAL INFORMATION

 

COCRYSTAL PHARMA, INC.

 

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except per share data)

 

   March 31, 2020   December 31, 2019 
   (unaudited)     
Assets          
Current assets:          
Cash  $21,686   $7,418 
Restricted cash   50    50 
Accounts receivable   644    644 
Prepaid expenses and other current assets   202    169 
Total current assets   22,582    8,281 
Property and equipment, net   494    431 
Deposits   39    50 
Operating lease right-of-use assets, net (including $40 to related party)   634    677 
Goodwill   19,092    19,092 
Total assets  $42,841   $28,531 
Liabilities and stockholders’ equity          
Current liabilities:          
Accounts payable and accrued expenses  $1,659   $1,999 
Current maturities of finance lease liabilities   50    103 
Current maturities of operating lease liabilities (including $59 to related party)   182    177 
Derivative liabilities   34    7 
Total current liabilities   1,925    2,286 
Long-term liabilities:          
Finance lease liabilities   10    14 
Operating lease liabilities (including $40 to related party)   475    523 
Total long-term liabilities   485    537 
Total liabilities   2,410    2,823 
Commitments and contingencies          
Stockholders’ equity:          
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   277,628    260,932 
Accumulated deficit   (237,250)   (235,260)
Total stockholders’ equity   40,431    25,708 
Total liabilities and stockholders’ equity  $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 

 

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-4

 

 

COCRYSTAL PHARMA, INC.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

1. Organization and Business

 

Cocrystal Pharma, Inc. (“we”, the “Company” or “Cocrystal”), a biopharmaceutical company incorporated in Delaware, has been developing novel technologies and approaches to create first-in-class or 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.

 

The Company’s activities since inception have principally consisted of acquiring 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 strategic alliances. Through March 31, 2020, the Company has primarily funded its operations through equity offerings.

 

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, 2019 filed on March 27, 2020 (“Annual Report”).

 

Principles of Consolidation

 

The 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 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 consolidated financial statements and accompanying notes. The significant estimates in the Company’s 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 U.S. financial institutions, which may, at times, exceed federally insured limits of $250,000 for each institution accounts are held. At March 31, 2020 and December 31, 2019, our primary operating account held approximately $21,686,000 and $7,418,000, respectively, and our collateral account balance was $50,000 at a different institution. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risks thereof.

 

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

 

Fair Value Measurements

 

FASB Accounting Standards Codification (“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 2 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 7 – Warrants.

 

At March 31, 2020 and December 31, 2019, the carrying amounts of financial 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 based on prevailing market interest rates.

 

The Company’s derivative liabilities are considered Level 2 measurements.

 

Goodwill

 

In November 2014, goodwill was 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 program 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.

 

F-6

 

 

At March 31, 2020, the Company had goodwill of $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 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. 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 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.

 

The Company recognized revenue for the three months ended March 31, 2020 and 2019 were $461,000 and $5,078,000, respectively. As of March 31, 2020, accounts receivable of $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 March 31, 2020, the Company assessed its income tax expense based on its projected future taxable income for the year ended December 31, 2020 and therefore recorded no amount for income tax expense for the three months ended 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, 2019 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’s Simplified Method for Estimate Expected Term. The risk-free interest rate is estimated using comparable published federal funds rates.

 

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

 

In June 2016, the FASB issued ASU No. 2016-13, 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 notes receivables. The standard will replace today’s “incurred loss” approach with an “expected loss” model, under which companies will recognize allowances based on expected rather than incurred losses. Entities will apply the standard’s provisions as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is effective. The standard is effective for interim and annual reporting periods beginning after December 15, 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 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 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 March 31, 2020, and December 31, 2019, property and equipment consists of (in thousands):

 

   March 31, 2020   December 31, 2019 
Lab equipment (excluding equipment under finance leases)  $1,138   $1,073 
Finance lease right-of-use lab equipment obtained in exchange for finance lease liabilities   347    347 
Computer and office equipment   120    92 
Total property and equipment   1,605    1,512 
Less: accumulated depreciation and amortization   (1,111)   (1,081)
Property and equipment, net  $494   $431 

 

Total depreciation and amortization expense were $30,000 and $23,000 for the three months ended March 31, 2020 and 2019 respectively, which includes amortization expense of $17,000 for both years. For additional finance leases information, refer to Note 9 – Commitments and Contingencies.

 

4. Accounts Payable and Accrued Expenses

 

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

 

   March 31, 2020   December 31, 2019 
Accounts payable  $922   $1,511 
Accrued compensation   107    83 
Accrued other expenses   630    405 
Total accounts payable and accrued expenses  $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-9

 

 

5. Common Stock

 

As of March 31, 2020, the Company has authorized 100,000,000 shares of common stock, $0.001 par value per share. The Company had 52,140,699 and 35,150,058 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively.

 

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

 

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 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. In October 2019, the Company and 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 been raised to date).

 

On January 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 29, 2020, the Company entered into a securities purchase agreement with certain institutional investors, pursuant to which the Company agreed to sell and issue, in a registered direct offering, 3,492,063 shares of common stock at a 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 other estimated offering expenses payable by the Company. The Company closed the offering on January 31, 2020.

 

On February 27, 2020, the Company entered into a securities 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 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 a 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 Company of approximately $6.8 million, before deducting fees payable to the placement agent, lock-up settlement fee and other estimated offering expenses payable by the Company. The Company closed the offering on March 10, 2020.

 

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 2,705,237 (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 March 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 three months ended 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, 2019   3,588    931   $4.14   $            - 
Exercised   -    -    -    - 
Granted   -    -    -    - 
Cancelled   8    (8)   2.94    - 
Balance at March 31, 2020   3,596    923    4.15    - 

 

The Company did not grant any options during the three months ended March 31, 2020, nor the three months ended 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 months ended March 31, 2020 and 2019, equity-based compensation expense recorded was $107,000 and $33,000, respectively.

 

As of March 31, 2020, there was approximately $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 1.4 years. For options granted and outstanding, there were 923,065 options outstanding which were fully vested or expected to vest, with an aggregate intrinsic value of $0, a weighted average exercise price of $4.15, and weighted average remaining contractual term of 7.84 years at March 31, 2020. For vested and exercisable options, outstanding shares totaled 413,690, with an aggregate intrinsic value of $0. These options had a weighted average exercise price of $5.84 per share and a weighted-average remaining contractual term of 7.1 years at March 31, 2020.

 

The aggregate intrinsic value of outstanding and exercisable options at March 31, 2020 was calculated based on the closing price of the Company’s common stock as reported on The Nasdaq Capital Market on March 31, 2020 of $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:

 

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

 

F-11

 

 

7. Warrants

 

The following is a summary of activity in the number of warrants outstanding to purchase the Company’s common stock for the three months ended March 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, 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 March 31, 2020:

 

   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 December 31, 2019:

 

  

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 

 

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 life assumption is based on the remaining contractual terms of the warrants. The risk-free rate is based on the zero 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.

 

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 to discover and develop certain proprietary influenza A/B antiviral agents. Under the terms of the Collaboration Agreement, Merck funds 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.

 

The Company recognized $461,000 in revenues on the condensed consolidated statement of operations and recorded the same amount in accounts receivable on the condensed consolidated balance sheet, for the three months ended and as of March 31, 2020, respectively, related to influenza A/B program research and development expenses for the first quarter of 2020.

 

F-12

 

 

Kansas State University Research Foundation

 

Cocrystal 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 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 agreed to pay the Foundation a one-time non-refundable license initiation fee of $80,000 under the License Agreement, and annual license maintenance fees. The Company also agreed to make certain future milestone payments, dependent upon the progress of clinical trials, regulatory approvals, and initiation of commercial sales in the United States and certain countries outside the United States. See Note 11, Subsequent Events with respect to another License Agreement with the foundation.

 

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 10 – Transactions with Related Parties). Leases 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 4.5 years.

 

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

 

2020 (excluding the three months ended March 31, 2020)  $170 
2021   213 
2022   178 
2023   183 
Thereafter   15 
Total operating lease payments   759 
Less: present value discount   (102)
      
Total operating lease liabilities  $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 three months ended March 31, 2020 and 2019, approximately $20,000 and $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 10 – 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.

 

F-13

 

 

For the three months ended March 31, 2020 and 2019, operating lease expense, excluding short-term leases, finance leases and CAM charges, totaled approximately $44,000 and $43,000, respectively.

 

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 1.7 years.

 

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

 

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 March 31, 2020, total right-of-use lab equipment and accumulated depreciation recognized under finance leases is $347,000 and $93,000, respectively, and depreciation expense for the three months ended March 31, 2020 was $17,000. As of December 31, 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 $76,000.

 

At 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, was $117,000 and the Company expects to pay future interest charges of $4,000 over the remaining finance lease terms. For the three months ended March 31, 2019, the Company paid $52,000 and $6,000 in principal and interest, respectively, totaling financing cash out flows of $52,000, net of interest expense, for amount included in the measurement of lease liabilities for finance 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, 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. 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. Pepe 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 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.

 

Liberty Insurance Underwriters Inc. filed suit against us in federal court in Delaware seeking a declaratory judgment that it is not liable to defend us in the class 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. The plaintiff’s appeal was denied and the 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.

 

COVID-19

 

Our administrative and finance activities are fully functional out of our Miami, 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 continue working remotely and we remain committed to meeting our corporate and development milestones throughout the year. We have experienced delays in our supply chain and with service partners as a result of the COVID-19 pandemic. Also because of the unknown impact from the COVID-19 pandemic, it may have unanticipated material adverse 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.

 

10. Transactions with Related Parties

 

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 $14,000 and $14,000 for the three months ended March 31, 2020 and 2019, respectively.

 

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 agreed to pay the Foundation a one-time non-refundable license initiation fee of $110,000 and annual license maintenance fees. The Company also agreed to make certain future milestone payments, dependent upon the progress of clinical trials, regulatory approvals, and initiation of commercial sales in the United 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-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, Coronavirus, Hepatitis C virus (“HCV”), and Norovirus 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 three months ended 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 months 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 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.

 

We initiated 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 were 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 eight subjects that achieved SVR12 had significantly higher frequencies of terminally differentiated effector memory CD8+ T cells compared with the four that relapsed at both baseline and at end-of-6-week treatment. The trial and the final study report have been completed

 

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. Due to unrest in Hong Kong and the coronavirus pandemic, the clinical trial agreement has been terminated effective March 24, 2020.

 

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

 

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 Months Ended March 31, 2020 compared to the Three Months Ended March 31, 2019

 

Revenue

 

Revenue recorded for the three months ended March 31, 2020 was $461,000, compared with $5,078,000 for the three months ended March 31, 2019. The revenue for the three months ended March 31, 2019 included $4,368,000 as consideration in exchange for conveyance of intellectual property rights at the signing of the Merck Collaboration Agreement executed on January 2, 2019. Currently, reimbursement of research and development expenses under the Collaboration Agreement is our only source of revenue.

 

4

 

 

Research and Development Expense

 

Research and development expense consist 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 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 March 31, 2020 and 2019 were $1,283,000 and $878,000, respectively. The increase of $405,000 was primarily due increases in COVID-19 and 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 for the three months ended March 31, 2020 and 2019 were approximately $1,139,000 and $1,323,000, respectively. The decrease of $184,000 was primarily due to decreased audit related fees, resulting from a change in our independent registered public accounting firm in April 2019, and legal services that included contracts, litigation and patent related matters.

 

Interest Expense, Net

 

Interest expense for the three months ended March 31, 2020 and 2019 were approximately $2,000 and $6,000, respectively. The interest amounts represent interest incurred on finance leased lab equipment in 2019. Interest income was negligible for the three months ended March 31, 2020 and 2019.

 

Other Income/(Expense)

 

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. The change in the fair value of derivative liabilities for the three months ended March 31, 2020 and 2019 was $27,000 and $100,000, respectively.

 

Income Taxes

 

No income tax benefit or expense was recognized for the three months ended 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.

 

Net Income (Loss)

 

As a result of the above factors, for the three months ended 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 of $2,018,000 for the same period in 2019. This was primarily due to the $4,000,000 upfront payment from Merck at the signing of the Collaboration Agreement in January 2019.

 

Net cash used for investing activities was approximately $93,000 for the three months ended March 31, 2020 compared with $25,000 net cash used for the same period in 2019. For the three months ended March 31, 2020 and 2019, net cash used for investing activities consisted primarily of capital spending for computers and lab equipment.

 

Net cash provided by financing activities totaled $16,547,000 for the three 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 in three registered direct offerings during the three months ended March 31, 2020.

 

5

 

 

The Company has not yet established an ongoing source of revenue sufficient to cover its operating costs. The Company had $21,686,000 cash on March 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 America applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal 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 February 27, 2020, the Company entered into a securities 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 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 a 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 Company of approximately $6.8 million, before deducting fees payable to the placement agent and other estimated offering expenses payable by the Company. The Company closed the 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 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, 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 potential under the Collaboration 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 continuing collaboration with Merck under the Collaboration Agreement, the future results of preclinical and clinical studies, general risks arising from clinical trials, receipt of regulatory approvals, development of effective treatments and/or vaccines by competitors, and our ability to find and 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, 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, 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, 2019 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

 

We carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934 (the “Exchange Act”) as of the 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 as of March 31, 2020 were effective to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms.

 

Changes in Internal Control over Financial Reporting

 

There were no material changes in our internal controls over financial reporting or in other factors that could materially affect, or are reasonably likely to affect, our internal controls over financial 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 future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

 

7

 

 

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, 2019.

 

ITEM 1.A RISK FACTORS

 

None.

 

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.

 

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.

 

8

 

 

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.

 

9

 

 

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: May 13, 2020 By: /s/ Gary Wilcox
    Gary Wilcox
    Chief Executive Officer
    (Principal Executive Officer)

 

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

 

10

 

 

Portions of this document have been omitted as permitted by the rules of the Securities and Exchange Commission. The information excluded is both (i) not material and (ii) would be competitively harmful if publicly disclosed. [*] designates the omitted information.

 

Exhibit 10.7

 

LICENSE AGREEMENT

 

BETWEEN

 

Cocrystal Pharma, Inc.

 

AND

 

KANSAS STATE UNIVERSITY RESEARCH FOUNDATION

 

 1 

 

 

LICENSE AGREEMENT

 

This LICENSE AGREEMENT (this “Agreement”), the effective date of which is February 12, 2020 (hereinafter “Effective Date”) is made by and between Kansas State University Research Foundation, a non-profit Kansas corporation having its principal office at 2005 Research Park Circle, Manhattan, Kansas, USA, 66502 (hereinafter referred to as “Foundation”) and Cocrystal Pharma, Inc., a corporation having its principal office at 19805 North Creek Parkway, Bothell, WA 98011 (hereinafter referred to as “Licensee”)(each of Foundation and Licensee, a “Party” and together the “Parties”).

 

RECITALS

 

  A. Foundation has been assigned the patent rights [*];
  B. Foundation desires to have products and services based on the inventions described in the Patent Rights developed and commercialized to benefit the public; and
  C. Licensee desires to obtain a license under the Patent Rights and Know-How.

 

NOW, THEREFORE, in consideration of the premises and the mutual promises and covenants contained herein, the Parties hereby agree as follows:

 

ARTICLE 1: DEFINITIONS

 

For the purposes of this Agreement, the following words and phrases shall have the following meanings:

 

1.1 Affiliate” means any individual or entity directly or indirectly controlling, controlled by or under common control with, a Party to this Agreement. For purposes of this Agreement, the direct or indirect ownership of over fifty percent (50%) of the profits or earnings of an entity shall be deemed to constitute control. Such other relationship as in fact results in actual control over the management, business and affairs of an entity shall also be deemed to constitute control. For the limited scope of this Agreement, Kansas State University (hereinafter the “University”) is deemed to be an Affiliate of Foundation.
   
1.2 Confidential Information” as used in this Agreement means all information in any form whatsoever disclosed in any manner by or on behalf of one Party or its Affiliates to the other Party or any of its Affiliates before or after the Effective Date and includes without limitation information about products, raw materials, packaging, manufacturing processes, samples, technical information, scientific information, financial information, business information, customer and supplier lists, and the terms and conditions of this Agreement.
   
1.3 Control” means, with respect to any item of Know-How, Patent Right, or other intellectual property right, a Party has the ability (whether by sole, joint or other ownership interest, license, sublicense or otherwise, and including any such abilities which are contingent) (other than by operation of the licenses granted in this Agreement) to grant a license, sublicense, access or right to use (as applicable) under such item of Know-How, Patent Right, or other intellectual property right to the other Party on the terms and conditions set forth herein at the time of such grant, in each case without breaching the terms of any agreement with a third party.
   
1.4 Omitted

 

 2 

 

 

1.5 Omitted
   
1.6 Field of Use” means the use of “Licensed Products” for antiviral therapeutics for humans, as well as antiviral diagnostic and prophylactic uses for humans. Excluded from the Field of Use is any use of compound known as [*].
   
1.7 Know-How” means any subject matter owned or Controlled by Foundation relating to the subject matter of the Patent Rights but not claimed in the Patent Rights and otherwise not known to the general public.
   
1.8 Licensed Products” means on a country-by-country basis, any product for use in the Field of Use.
   
1.9 Net Sales” means the gross amount of monies or cash equivalent or other consideration which is paid by unaffiliated third parties to Licensee, and its sublicensee’s billings for Licensed Products less the sum of the following:

 

  a. discounts allowed in amounts customary in the trade;
  b. sales, tariff duties and/or use taxes directly imposed and with reference to particular sales;
  c. outbound transportation and insurance prepaid or allowed;
  d. amounts allowed or credited on returns, rebates, chargebacks and other allowances; and
  e. retroactive price reductions that are actually allowed or granted.

 

  No deductions shall be made for commissions paid to individuals whether they are with independent sales agencies or regularly employed by Licensee and on its payroll, or for cost of collections. Licensed Products shall be considered “sold” when billed out or invoiced. For the purposes of calculating Net Sales, transfers to a sublicensee or an Affiliate of Licensed Product under this Agreement for (i) end use (but not resale) by the sublicensee or Affiliate shall be treated as sales by Licensee at list price of Licensee and (ii) resale by a sublicensee or an Affiliate shall not be treated as Net Sales, but the resale thereof shall be treated as Net Sales; provided, however, Net Sales shall not include any Licensed Products transferred for use in connection with clinical trials or other development activity, pre-clinical research and trials, promotional use (including samples), compassionate use or indigent programs. [For “compassionate use”, see
  https://www.fda.gov/news-events/public-health-focus/expanded-access
  https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/compassionate-drug-use.html]
   
1.10 Patent Rights” means any subject matter claimed in or disclosed by [*].
   
1.11 Term” the term of this Agreement shall commence on the Effective Date and, unless earlier terminated as provided in Article 11, shall continue in full force and effect until the expiration of the last to expire of the Patent Rights.
   
1.12 Territory” means worldwide.
   
1.13 Valid Patent Claim” means a claim in any issued and unexpired patent included in the Patent Rights, which claim has not been held invalid or unenforceable by the decision of a court or government agency or other appropriate body of competent jurisdiction (which decision is not appealable or has not been appealed within the time allowed for appeal), has not been abandoned or admitted to be invalid or unenforceable through reissue, reexamination or disclaimer, and has not been made unenforceable due to failure to pay maintenance fees.

 

 3 

 

 

ARTICLE 2: LICENSE GRANT

 

2.1 Subject to the terms and conditions set forth herein, Foundation hereby grants to Licensee an exclusive, royalty-bearing right and license in the Territory for the Field of Use to practice under the Patent Rights to make, have made, use, lease, sell, offer to sell, and import Licensed Products in the Territory until the end of the Term for which the Patent Rights are granted to the Foundation by the responsible agencies, unless this Agreement shall be sooner terminated according to the terms hereof.
   
2.2 Foundation also hereby grants to Licensee a non-exclusive right and license in the Territory for the Field of Use to practice under the Know-How to make, have made, use, lease, sell, offer to sell, and import Licensed Products in the Territory until the end of the Term for which the Patent Rights are granted to the Foundation by the responsible agencies, unless this Agreement shall be sooner terminated according to the terms hereof.
   
2.3 For clarity, Foundation shall be free to grant commercial licenses to the Patent Rights to third parties in all fields outside the Field of Use, which licenses shall not conflict with the terms of this Agreement and shall expressly deny any license or right to commercialize products within the Field of Use.
   
2.4 Foundation and the University have a reserved right to practice under the Patent Rights for non-commercial research and educational purposes within the mission of the University, adhering to the confidentiality provisions of Article 13.
   
2.5 Licensee shall have the right to enter into sublicensing agreements for the rights, privileges and licenses granted hereunder, provided that Licensee shall give Foundation written notice thereof within thirty (30) days after any such sublicense shall become effective. No such sublicense shall relieve Licensee of its obligations hereunder and Licensee and each such sublicensee shall execute documents to the foregoing effect, a copy of which and any amendments thereto will be furnished to Foundation promptly upon execution and delivery. Upon any termination of this Agreement, all sublicensee’s rights shall also terminate, except as provided in Section 11.7 hereof.
   
2.6 Licensee agrees that any sublicense granted by it shall be subject in all respects to restrictions, provisions and obligations in this Agreement and shall be binding upon the sublicensee as if it were a party to this Agreement and include a provision prohibiting the sublicensee from sublicensing its rights under such sublicense agreement.
   
2.7 Licensee shall not receive from sublicensee(s) anything of value in lieu of cash payments in consideration for any sublicense under this Agreement, without the express prior written permission of Foundation.
   
2.8 The license granted shall not be construed to confer any rights upon Licensee by implication, estoppel or otherwise as to any technology not specifically set forth in Patent Rights or Know-How.

 

 4 

 

 

2.9 Development of the invention was sponsored in part by the United States Government, and as a consequence this Agreement, any license agreement and the invention are subject to overriding obligations to the Federal Government (including a non-exclusive, irrevocable license to use the invention by or on behalf of the Government throughout the world), under 35 U.S.C. §§200-212 and applicable regulations.

 

ARTICLE 3: DUE DILIGENCE

 

3.1 Licensee shall use commercially reasonable efforts and shall cause its sublicensees to use commercially reasonable efforts: (a) to develop Licensed Products; (b) to introduce Licensed Products into the commercial market; and (c) to market Licensed Products following such introduction into the market; to the extent such Licensed Products are covered by a Valid Patent Claim.
   
3.2 Omitted.
   
3.3 Omitted
   
3.4 Until reporting begins under Section 5.2, Licensee shall, within sixty (60) days after the end of each calendar year starting in year 2021, furnish Foundation with a written report summarizing its, its Affiliates’ and its sublicensees’ efforts during the prior year to develop and commercialize Licensed Products, including: (a) research and development activities completed; (b) commercialization and/or other distribution efforts, including significant corporate transactions involving Licensed Products; and (c) marketing efforts. Each report must contain a sufficient level of detail for Foundation to assess whether Licensee is in compliance with its obligations under Section 3.1 and a discussion of intended efforts for the then current year. Together with each report, Licensee shall provide Foundation with a copy of the then current development plan for the current year, including an updated schedule of anticipated events or milestones.
   
3.5 Licensee’s failure to perform in accordance with Section 3.4 above shall be grounds for Foundation to terminate this Agreement pursuant to Section 11.3 herein, providing such deficiency is not remedied within ninety (90) days of notice by Foundation to Licensee that such deficiency exists.

 

 5 

 

 

ARTICLE 4: CONSIDERATION FOR GRANT OF LICENSE

 

4.1 For the rights, privileges and license granted, Licensee agrees to reimburse Foundation the sum of [*], payable thirty (30) days after the Effective Date, for third-party fees and expenses paid by Foundation prior to the Effective Date of this Agreement associated with the filing, prosecution and maintenance of the Patent Rights. The details of these fees are set forth in Appendix A (“Patent Fees”). Licensee shall also make the following payments to Foundation in the manner hereinafter provided during the Term:

 

  (a) LICENSE INITIATION FEE: Licensee shall pay to Foundation a non-refundable License Initiation Fee in the sum of eighty thousand dollars (USD $80,000), payable thirty (30) days after the Effective Date. This License Initiation Fee shall be separate from and unrelated to any other fees, such as, the Annual License Maintenance Fees, and Royalty payments set forth in this Article 4.
     
  (b) ANNUAL LICENSE MAINTENANCE FEE: Licensee shall pay the following annual license maintenance fees (the “Annual License Maintenance Fees”):
     
    Twenty thousand dollars (USD $20,000) each year.
     
    Such Annual License Maintenance Fees shall be due on the anniversary date of the Effective Date and are non-refundable. Royalty payments in a given license year shall be creditable against these Annual License Maintenance Fees.
     
  (c) RUNNING ROYALTIES: During the Term, Licensee shall pay Foundation running royalties in an amount equal to [*] of Net Sales of Licensed Products covered by a Valid Patent Claim (such royalties, the “Running Royalties”); provided, however, that in the event Licensee or its sublicensee or Affiliate is required to pay a third party in consideration for a license under any patent rights claiming the composition, use or manufacture of the Licensed Product, Licensee shall then be entitled to credit fifty percent (50%) of such third party payments against the Running Royalties with respect to the Net Sales of the Licensed Product, such credit not to exceed fifty percent (50%) of the Running Royalties otherwise due for any calendar quarter for the Licensed Product.
     
  (d) DEVELOPMENT MILESTONE PAYMENTS: Licensee will pay development milestone payments as set forth below within thirty (30) days after the achievement of the relevant milestone by Licensee, as applicable, or its affiliates or sublicensees.

 

Major Country” means the United Kingdom, France, Germany, Italy, Spain or Canada.  
   
Dosing of the first patient with the first Licensed Product in a Phase 1 clinical trial

[*]

Dosing of the first patient with the first Licensed Product in a Phase 2 clinical trial

[*]

Dosing of the first patient with the first Licensed Product in a Phase 3 clinical trial

[*]

Regulatory approval of the first Licensed Product in the United States [*]
First commercial sale of the first Licensed Product in the United States [*]
First commercial sale of the first Licensed Product in a Major Country outside North America. [*]

 

 6 

 

 

  (e) In addition to Running Royalties, a percentage of any upfront payments received by Licensee from sublicensees in consideration for sublicensing the Patent Rights shall be paid to Foundation based on the following schedule:

 

  [*]
  [*]
  [*]
  [*]

 

  (f) All payments made in accordance with subparagraphs 4.1(c) and 4.1(e) shall be credited against the Annual License Maintenance Fee provided for in 4.1(b), but only in the calendar year they are received by Foundation.

 

4.2 No multiple Running Royalties shall be payable because any Licensed Product, its manufacture, use, lease, importation or sale are or shall be covered by more than one Valid Patent Claim in one or more Patent Rights licensed under this Agreement.
   
4.3 All Running Royalty payments due hereunder shall be paid in full, without deduction of taxes or other fees which may be imposed by any government and which shall be paid by Licensee. Non-royalty payments under Section 4.1(e) shall be net of any transaction taxes or fees, not including income tax on profits, which may be imposed by any government upon receipt by Licensee.
   
4.4 A sale Running Royalties shall accrue when Licensed Products are invoiced, or if not invoiced, when delivered to a third party, not an Affiliate or sublicensee whose resale would constitute Net Sales. Licensee shall within sixty (60) days after March 31, June 30, September 30 and December 31, of each year, pay Running Royalties. Each payment shall be for Running Royalties accrued within Licensee’s most recently completed calendar quarter.
   
4.5 Royalty payments shall be paid in United States dollars (“USD”) without deduction of exchange, collection or other charges in Manhattan, Kansas, or at such other place as Foundation may reasonably designate consistent with the laws and regulations controlling in any foreign country. If any currency conversion shall be required in connection with the payment of Running Royalties, such conversion shall be made by using the exchange rate published in the Wall Street Journal on the last business day of the calendar quarterly reporting period to which such royalty payments relate.
   
4.6 All payments due Foundation shall be made out to “Kansas State University Research Foundation.” Payment may be remitted via bank wire transfer, at Licensee’s expense, in immediately available funds to such bank account in the United States designated in writing by Foundation from time to time.
   
4.7 The Running Royalty and other payments set forth in this Agreement and amounts due under Article 6 shall, if overdue, bear interest from and including the date payment is due until payment at a per annum rate equal to [*]. The payment of such interest shall not foreclose Foundation from exercising any other rights it may have as a consequence of the lateness of any payment.

 

 7 

 

 

ARTICLE 5: REPORTS AND RECORDS

 

5.1 Licensee shall keep full, true and accurate books of account containing all particulars that may be necessary for the purpose of showing the amounts payable by Licensee to Foundation. Said books of account shall be kept at Licensee’s principal place of business or the principal place of business of the appropriate division of Licensee to which this Agreement relates. Said books and the supporting data shall be open at all reasonable times for three (3) years following the end of the calendar year to which they pertain, to the inspection by an independent certified public accounting firm selected by Foundation and reasonably acceptable to Licensee, at Foundation’s expense, for the sole purpose of verifying Licensee’s royalty statements or compliance in other respects with this Agreement. The accounting firm shall disclose to Foundation whether the reports are correct or incorrect and the extent of any discrepancy. Should such inspection lead to the discovery of a greater than five percent (5%) discrepancy in reporting to Foundation’s detriment, Licensee agrees to pay the full cost of such inspection. Foundation may exercise its rights under this Section 5.1 only once every year per audited entity and only with reasonable prior notice to the audited entity.
   
5.2 Before the first commercial sale of a Licensed Product, Licensee shall submit the reports due under Section 3.4. After the first commercial sale of a Licensed Product, Licensee, within sixty (60) days after March 31, June 30, September 30 and December 31, of each year, shall deliver to Foundation true and accurate reports of the business conducted by Licensee and its sublicensee(s) during the preceding three-month period using a format similar to the example shown in Appendix B (“Royalty Report Form”). These shall include the following:

 

  (a) amount of Licensed Products manufactured and sold by Licensee and all sublicensees;
  (b) total billings for Licensed Products sold by Licensee and all sublicensees;
  (c) methods used to calculate the Running Royalty;
  (d) the exchange rate used;
  (e) deductions applicable as provided in Section 1.9;
  (f) non-royalty sublicensing payments due under Section 4.1(e);
  (g) total Running Royalties due; and
  (h) names and addresses of all sublicensees of Licensee.

 

With each such report submitted, Licensee shall pay to Foundation the royalties due and payable under this Agreement. Licensee shall provide such report even if no royalties shall be due.

 

 8 

 

 

ARTICLE 6: PATENT PROSECUTION

 

6.1 Foundation will be responsible for the preparation, filing, prosecution, protection, defense and maintenance of all Patent Rights, using independent patent counsel reasonably acceptable to Licensee. However, Foundation shall give Licensee the opportunity to provide comments on and make requests of Foundation concerning the preparation, filing, prosecution, protection, defense and maintenance of the Patent Rights, and shall seriously consider such comments and requests; however, final decision-making authority shall vest in Foundation.
   
6.2 Foundation, either directly or through its attorneys, shall keep Licensee or its designated attorneys adequately informed with respect to the filing, prosecution, and maintenance of all patent applications and patents licensed under this Agreement. Licensee shall have the right to request and receive additional information, as Licensee or its attorneys may require, including copies of patent applications, patents, patent office actions, and replies thereto.
   
6.3 Separate from the payments set forth in Article 4, Licensee shall reimburse Foundation for all reasonable costs associated with the Patent Rights incurred after the Effective Date and paid by Foundation or its Affiliate without reimbursement by a third party. These reimbursements shall be due within thirty (30) days after receipt of Foundation’s invoice by Licensee, and shall be non-refundable and non-creditable. To the extent practicable, such expenses shall be pre-approved by Licensee, and Foundation agrees to consult with Licensee as to the preparation, filing, prosecution and maintenance of the Patent Rights and shall furnish to Licensee copies of relevant documents in Foundation’s or its counsel’s possession reasonably in advance of such consultation. If Licensee fails to provide direction before two (2) weeks prior to a deadline, Foundation will proceed on its own judgment and, provided that Licensee has received two (2) months’ prior notice of the deadline, Licensee shall be responsible for costs as if pre-approved. If, by two (2) weeks prior to expiration of a filing deadline, Licensee elects not to make such payment, Foundation may elect to make such payment at Foundation’s own cost, in which case Licensee shall have no further rights with respect to said specific patent action, any other Section of this Agreement notwithstanding.
   
6.4 If Licensee decides that it does not wish to pay for the prosecution or maintenance of any Patent Rights in a particular country, Licensee shall provide Foundation with prompt written notice of such election. Upon receipt of such notice by Foundation, Licensee shall be released from its obligation to reimburse Foundation for such expenses incurred thereafter as to such Patent Rights; provided, however, that expenses authorized prior to the receipt by Foundation of such notice shall be deemed incurred prior to the notice. In the event of Licensee’s election hereunder to no longer pay for prosecution or maintenance of any Patent Rights, any license granted by Foundation to Licensee hereunder with respect to such Patent Rights will terminate, and Licensee will have no rights whatsoever to exploit such terminated Patent Rights. Foundation will then be free, without further notice or obligation to Licensee, to grant rights in and to such terminated Patent Rights to third parties in the Field of Use, while Licensee shall retain full rights hereunder with respect to all other patent rights then within the Patent Rights.

 

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ARTICLE 7: INFRINGEMENT

 

7.1 Either Party shall promptly inform the other Party in writing of any alleged infringement of the Patent Rights by a third party and shall provide the other Party with any available evidence thereof. Neither Party shall notify a third party of the infringement of Patent Rights without first consulting with the other Party. Both Parties shall use reasonable efforts and cooperation to terminate infringement without litigation.
   
7.2 During the Term, Licensee shall have the first right, but not the obligation, to prosecute at its own expense all infringements of the Patent Rights and, in furtherance of such right, Foundation hereby agrees that Licensee may include Foundation as a party plaintiff in any such suit, without expense to Foundation provided, however, that such right to bring such an infringement action shall remain in effect only for so long as the license granted herein remains exclusive. The total cost of any such infringement action commenced or defended solely by Licensee shall be borne by Licensee. No settlement, consent judgment or other voluntary final disposition of the suit may be entered into without the consent of Foundation, which consent shall not unreasonably be withheld. Licensee shall indemnify Foundation against any order for costs that may be made against Foundation in such proceedings.
   
7.3 In the event that Licensee shall undertake the enforcement and/or defense of the Patent Rights by litigation, Licensee may withhold up to fifty percent (50%) of the payments otherwise due Foundation under Article 4 herein and apply the same toward reimbursement of up to half of Licensee’s third-party litigation expenses, including reasonable attorneys’ fees, in connection therewith. Any recovery of damages by Licensee for each such suit shall be applied first in satisfaction of any unreimbursed expenses and legal fees of Licensee relating to such suit, and next toward reimbursement of Foundation for any payments under Article 4 past due or withheld and applied pursuant to this Article 7. Licensee shall receive sixty percent (60%), and Foundation shall receive forty percent (40%) of the balance of any recovery, damages, or settlement proceeds after the foregoing allocation is performed.
   
7.4 If within six (6) months after having been notified of any alleged infringement, Licensee shall have been unsuccessful in persuading the alleged infringer to desist and shall not have brought and shall not be diligently prosecuting an infringement action, or if Licensee shall notify Foundation at any time prior thereto of its intention not to bring suit against any alleged infringer then, and in those events only, Foundation shall have the right, but shall not be obligated, to prosecute at its own expense any infringement of the Patent Rights, and Foundation may, for such purposes, use the name of Licensee as party plaintiff.
   
7.5 In the event that Foundation shall undertake enforcement and/or defense of the Patent Rights litigation, any recovery, damages or settlement derived from such action shall be applied first in satisfaction of any unreimbursed expenses and legal fees of Foundation. Foundation shall receive sixty percent (60%), and Licensee shall receive forty percent (40%) of the balance of any recovery, damages, or settlement proceeds after the foregoing allocation is performed.
   
7.6 In the event that a declaratory judgment action alleging invalidity or noninfringement of any of the Patent Rights shall be brought against Licensee, Foundation, at its option, shall have the right, within thirty (30) days after commencement of such action, to intervene and take over the sole defense of the action at its own expense, provided that Foundation consults with and keeps Licensee promptly informed regarding such declaratory judgment action.
   
7.7 In any infringement suit as either Party may institute to enforce the Patent Rights pursuant to this Agreement, the other Party hereto shall, at the request and expense of the Party initiating such suit, cooperate in all respects and, to the extent possible, have its employees (and employees of University) testify when requested and make available relevant records, papers, information, samples, specimens, and the like.

 

 10 

 

 

7.8 Licensee shall have the sole right in accordance with the terms and conditions herein to sublicense any alleged infringer for future use of the Patent Rights. Any upfront fees as part of such a sublicense shall be first be used to reimburse the costs of the Party bringing the infringement action against the infringer and the balance will be shared with Foundation in accordance with Section 4.1(e); other royalties shall be treated per Article 4.

 

ARTICLE 8: LIABILITIES AND WARRANTIES

 

8.1 Licensee represents and warrants that it will comply, and will require that its Affiliates and sublicensees comply, with all applicable local, state, federal and international laws and regulations relating to the development, manufacture, use, sale and importation of Licensed Products. Without limiting the foregoing, Licensee represents and warrants, that is shall comply, and will require its Affiliates and sublicensees to comply, with all applicable United States laws and regulations controlling the export of certain commodities and technical data, including without limitation all applicable Export Administration Regulations of the United States Department of Commerce. Among other things, these laws and regulations prohibit or require a license for the export of certain types of commodities and technical data to specified countries. Licensee hereby gives written assurance that it will comply with, and will require that its Affiliates and sublicensees comply with, all applicable United States export control laws and regulations, that it bears sole responsibility for any violation of such laws and regulations by itself or its Affiliates or sublicensees, and that it will indemnify, defend, and hold the Foundation Indemnitees harmless (in accordance with Section 8.2) for the consequences of any such violation.
   
8.2 Licensee shall at all times during the Term and thereafter, indemnify, defend and hold Foundation, the University, and their trustees, agents, their directors, officers, employees, inventors/assignors and Affiliates (collectively, the “Foundation Indemnitees”), harmless against all third-party claims, proceedings, demands and liabilities of any kind whatsoever, including legal expenses and reasonable attorneys’ fees (collectively, “Foundation Claims”), arising out of the death of or injury to any person or persons or out of any damage to property, resulting from the production, manufacture, sale, use, lease, consumption or advertisement of the Licensed Products by Licensee or its sublicensees or arising from any obligation of Licensee hereunder. The rights and obligations of this section shall survive termination or expiration of the Agreement with respect to Foundation Claims arising during the Term. Notwithstanding the foregoing, each of Foundation Indemnitees shall not be entitled to indemnification for any claim, liability, loss, cost, damage, or expenses to the extent caused by the fraud or willful misconduct of a Foundation Indemnitee or breach of this Agreement by Foundation.
   
8.3 Foundation shall at all times during the Term and thereafter, indemnify, defend and hold Licensee, and its, agents, their directors, officers, employees, inventors/assignors and Affiliates (collectively, the “Licensee Indemnitees”), harmless against all third-party claims, proceedings, demands and liabilities of any kind whatsoever, including legal expenses and reasonable attorneys’ fees (collectively, “Licensee Claims”), arising from any obligation of Foundation Indemnitees hereunder. The rights and obligations of this section shall survive termination or expiration of the Agreement with respect to Licensee Claims arising during the Term. Notwithstanding the foregoing, each of Licensee Indemnitees shall not be entitled to indemnification for any claim, liability, loss, cost, damage, or expenses to the extent caused by the fraud or willful misconduct of a Licensee Indemnitee or breach of this Agreement by Licensee.

 

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8.4 Licensee acknowledges it has or can establish the skill, knowledge, and capability to develop, produce, manufacture, market, and sell Licensed Products and/or Services.
   
8.5 Foundation represents and warrants that:

 

  (a) Foundation Controls, and has been assigned all right, title and interest in, the Patent Rights;
  (b) Foundation has the right and authority to enter into this Agreement and to grant the rights and licenses herein granted;
  (c) To the best of Foundation’s knowledge, there are no outstanding assignments, grants, licenses, encumbrances, obligations or agreements, either written or implied, inconsistent with the rights and licenses granted to Licensee under this Agreement;
  (d) Foundation has not executed and will not execute any agreement in conflict herewith and has not granted and will not grant any license rights to the Patent Rights and Know-How for the Field of Use;
  (e) To the best of Foundation’s knowledge, the Patent Rights do not infringe the rights of third parties; and
  (f) Foundation’s obligations undertaken under this Agreement are valid and enforceable.

 

8.6 Nothing in this Agreement shall be construed as: (1) a warranty by Foundation that it can or will be able to obtain patents on patent applications included in the Patent Rights, or that any of the Patent Rights will afford adequate or commercially worthwhile protection; (2) a warranty or representation that any or all Patent Rights would be found valid by a court of competent jurisdiction; (3) a warranty or representation that anything made, used, sold or otherwise disposed of by Licensee under the rights and licenses or sublicenses granted in this Agreement is or will be free from infringement of patents of third parties (except as expressly provided in Section 8.4(e)); or (4) conferring by implication or otherwise any license or rights under any patents of Foundation other than the Patent Rights, provided, however, that Foundation shall not invoke any dominant patent or patent application Controlled by the Foundation to in any way restrict the rights and/or licenses granted to Licensee under this Agreement.
   
8.7 Except as otherwise expressly set forth in this agreement, Foundation, ITS trustees, agents, Directors, officers, employees, inventors/assignors and affiliates make no representations and extend no warranties of any kind, either express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose, validity of Patent Rights, claims, issued or pending, and the absence of latent or other defects, whether or not discoverable. Nothing in this agreement shall be construed as a representation made or warranty given by Foundation that the practice by Licensee of the License granted hereunder shall not infringe the Patent Rights of any third party (EXCEPT AS EXPRESSLY PROVIDED IN SECTION 8.4(e)). In no event shall Foundation, its trustees, agents, directors, officers, employees, inventors/assignors and affiliates OR LICENSEE AND ITS AFFILIATES AND SUBLICENSEES be liable for incidental or consequential damages of any kind, including economic damage or injury to property and lost profits, regardless of whether Foundation OR LICENSEE shall be advised, shall have other reason to know, or in fact shall know of the possibility.

 

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ARTICLE 9: NON-USE OF NAMES

 

9.1 Licensee shall not use the names or trademarks of the University or Foundation, nor any adaptation thereof, nor the names of any of their employees, unless said employee is or was also an employee of Licensee, in any advertising, promotional or sales literature without prior written consent obtained from University, Foundation or said employee, in each case; except that Licensee may state that it is licensed by Foundation under one or more of the patents and/or applications comprising the Patent Rights.
   
9.2 Foundation and University shall not use the names or trademarks of Licensee, nor any adaptation thereof, nor the names of any of its employees, in any advertising, promotional or sales literature without prior written consent obtained from Licensee, in each case; except that Foundation may state that it is has licensed Licensee under one or more of the patents and/or applications comprising the Patent Rights, to the extent required or affirmatively permitted under Foundation or University policy or state statute or regulation.

 

ARTICLE 10: GOVERNMENTAL MATTERS

 

10.1. If this Agreement or any associated transaction is required by the law of any nation to either be approved or registered with any governmental agency, Licensee shall assume all legal obligations to do so. Licensee shall notify Foundation if it becomes aware that this Agreement is subject to a United States or foreign government reporting or approval requirement. Licensee shall make all necessary filings and pay all costs including fees, penalties, and all other out-of-pocket costs associated with such reporting or approval process.
   
10.2. Licensee shall observe all applicable United States and foreign laws with respect to the transfer of Licensed Products and related technical data to foreign countries, including without limitation, the International Traffic in Arms Regulations and the Export Administration Regulations.

 

ARTICLE 11: TERMINATION

 

11.1. Either Party may terminate this Agreement immediately upon filing or institution by or against the other Party of bankruptcy, reorganization, liquidation or receivership proceedings (unless any involuntary proceeding that is filed or instituted against the other Party is not dismissed within ninety (90) days), or upon an assignment of a substantial portion of the assets for the benefit of creditors by either Party.
   
11.2. Should Licensee fail to make any payment whatsoever due and payable to Foundation, Foundation shall have the right to terminate this Agreement effective on thirty (30) days’ written notice, unless Licensee shall make all such payments to Foundation within said thirty (30) day period or unless Licensee is contesting in good faith the obligation to make the payment. Upon the expiration of the thirty (30) day period, if Licensee shall not have made all such payments to Foundation or is not contesting in good faith the obligation to make the payment, the rights, privileges and license granted shall automatically terminate. Obligations and payments due at the time of termination shall survive termination.
   
11.3. Upon any material breach or default of any of the provisions of this Agreement by Licensee other than those occurrences set out in Sections 11.1 and 11.2 hereinabove, which shall always take precedence in that order over any material breach or default referred to in this Section 11.3, Foundation shall have the right to terminate this Agreement and the rights, privileges and license granted hereunder effective on ninety (90) days written notice to Licensee. Such termination shall become automatically effective unless Licensee shall have cured any such material breach or default prior to the expiration of the ninety (90) day period and informed Foundation thereof in writing.

 

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11.4. Licensee shall have the right to terminate this Agreement at any time on thirty (30) days’ notice for futility, or on ninety (90) days’ notice for any reason to Foundation, and upon payment of all amounts due Foundation through the Effective Date of the termination.
   
11.5. Upon any material breach or default of any of the provisions of this Agreement by Foundation, Licensee shall have the right to terminate this Agreement effective on sixty (60) days’ written notice to Foundation. Such termination shall become automatically effective unless Foundation shall have cured such breach prior to the expiration of the sixty (60) day period and informed Licensee thereof.
   
11.6. Upon termination of this Agreement for any reason, nothing herein shall be construed to release either Party from any obligation that matured prior to the Effective Date of such termination; and Articles 1, 8, 11, and 13 shall survive any such termination. Licensee and any sublicensee thereof may, however, for up to six (6) months after the effective date of such termination, sell all Licensed Products, and complete Licensed Products in the process of manufacture at the time of such termination and sell the same, provided that Licensee shall make the payments to Foundation as required by Article 4 and Article 6 of this Agreement and shall submit the reports required by Article 5 hereof.
   
11.7. Upon termination of this Agreement for any reason other than by Licensee pursuant to Section 11.4 or 11.5, any sublicensee not then in default shall have the right to have its sublicense become a direct license from Foundation upon the terms hereof, as further limited in scope, field and terms set forth in the original sublicense, if the sublicensee pays Foundation all amounts Foundation would have received from Licensee with respect to the sublicense if this Agreement had not been terminated.

 

ARTICLE 12: NOTICES

 

Any notice, payments, or reporting required to be given under this Agreement shall be deemed to have been sufficiently given, if mailed by Certified Mail, postage prepaid, or by special courier, addressed to the Party to be notified at its address shown below, or at such other address as may later be furnished in writing to the notifying Party.

 

In the case of Foundation:

 

Attention: President

Kansas State University Research Foundation

2005 Research Park Circle

Manhattan, Kansas 66502

[*]

 

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In case of Licensee:

 

Attention: President

Cocrystal Pharma, Inc.

19805 North Creek Parkway

Bothell, WA 98011

[*]

 

ARTICLE 13. CONFIDENTIALITY

 

13.1. The Parties agree to hold in confidence all Confidential Information; to not disclose any Confidential Information to any third party, to use Confidential Information solely for the purposes of this Agreement, and to disclose such Confidential Information only to individuals within receiving Party’s organization that are directly involved with the Agreement on a need-to-know basis, except as set forth in Sections 13.2 and 13.3.
   
13.2. Each Party receiving or having access to Confidential Information from the other Party, whether in oral, written, graphic, computer-generated, or any other form, shall exercise due care to prevent its unauthorized disclosure. “Confidential Information” hereunder shall not include or information that:

 

  (a) is or becomes publicly known through no wrongful act, omission or fault of the receiving Party;
  (b) the receiving Party can reasonably demonstrate is already in the possession of the receiving Party as a matter of right;
  (c) is received after the date hereof from a third party without restriction and without breach of this Agreement; or
  (d) is independently developed by the receiving Party as evidenced by its records kept in the ordinary course of business.

 

  Nothing herein shall be interpreted to prohibit Licensee from publishing the results of its studies with respect Licensed Products in accordance with industry practices or from disclosing Foundation’s Confidential Information to third parties that Licensee deems necessary or advisable in the ordinary course of business on the condition that such third parties agree to be bound by confidentiality and non-use obligations that substantially are no less stringent than those confidentiality and non-use provisions contained in this Agreement.
   
13.3.  The receiving Party may disclose Confidential Information received from the disclosing Party if it is required to be disclosed pursuant to law or regulation or an order or requirement of a competent court, administrative agency, or other governmental body, provided that the receiving Party: (i) uses reasonable efforts to disclose no more of the received Confidential Information than is necessary to comply with such requirement; and (ii) to the extent permitted promptly notifies the disclosing Party of such requirement so that the disclosing Party may seek a protective order or other remedy.
   
13.4. Unless otherwise specified in writing, all Confidential Information remains the disclosing Party’s property. Upon termination or expiration of this Agreement and request of the disclosing Party, the receiving Party agrees to return or destroy all Confidential Information received from the disclosing Party, except for one copy, which the receiving Party may keep solely to monitor its obligations under this Agreement.

 

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13.5. The secrecy obligations of Company with respect to Confidential Information shall continue for a period ending five (5) years from the termination date of this Agreement.
   
13.6. Foundation shall not, and shall cause the University not to, publish any information pertaining to the Patent Rights or Know-How that could constitute Confidential Information of Foundation or the University without first providing Licensee a copy of the proposed publication or any modification thereof at least thirty (30) days prior to the proposed publication. Licensee may request a reasonable delay in publication or presentation in order to protect patentable information. If Licensee requests a delay to protect patentable information, Foundation or the University will delay the proposed submission for publication for a period not to exceed thirty (30) days to enable a filing with the patent office to protect such information. Upon expiration of such thirty (30) days, Foundation or the University will be free to proceed with submitting the proposed publication.

 

ARTICLE 14: MISCELLANEOUS PROVISIONS

 

14.1 This Agreement shall be construed, governed, interpreted and applied in accordance with the laws of the State of Kansas, without giving effect to any choice or conflict of law provision, except that questions affecting the construction and effect of any patent shall be determined by the law of the country in which the patent shall have been granted.
   
14.2 The Parties hereto acknowledge that this Agreement sets forth the entire Agreement and understanding of the Parties hereto as to the subject matter hereof, and shall not be subject to any change or modification except by the execution of a written instrument subscribed to by the Parties hereto.
   
14.3 This Agreement may not be assigned by either Party without the written consent of the other, which consent shall not be unreasonably withheld, except that each Party may, without such consent, assign this Agreement and the rights, obligations and interests of such Party to any purchaser of all or substantially all of its assets or all of its equity, or to any successor corporation resulting from any merger or consolidation of such Party with or into such corporation; provided, in each case, that the assignee agrees in writing to be bound by the terms of this Agreement. Any assignment purported or attempted to be made in violation of the terms of this Section 14.3 shall be null and void and of no legal effect.
   
14.4 The provisions of this Agreement are severable, and in the event that any provisions of this Agreement shall be determined to be invalid or unenforceable under any controlling body of the law, such invalidity or unenforceability shall not in any way affect the validity or enforceability of the remaining provisions hereof.
   
14.5 The failure of either Party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other Party.
   
14.6 This Agreement is the joint product of the Parties hereto and their respective counsel. Each provision hereof has been subject to the mutual consultation, negotiation, and agreement of the Parties and shall not be construed for or against either Party hereto on the basis of authorship thereof.

 

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IN WITNESS WHEREOF, the Parties hereto have executed this Agreement by proper persons thereunto duly authorized as of the Effective Date.

 

COCRYSTAL PHARMA, INC.:   KANSAS STATE UNIVERSITY
    RESEARCH FOUNDATION:
         
     
By: Sam Lee   By: Kent Glasscock
Title: President   Title: President and CEO
         
Date:     Date:  

 

 17 

 

 

APPENDIX A – PATENT FEES

 

[*]

 

 18 

 

 

APPENDIX B - ROYALTY REPORT FORM

 

Please also complete a separate form for each Affiliate and sublicensee for each product sold.

 

Submitted by: ______________________________(Cocrystal Pharma, Inc.)
Submit to: Kansas State University Research Foundation
Report Period: Beginning date: __________________             Ending date: __________________

 

 

 

Product Number and Description

 

 

 

Licensee submits the following royalty report for the period indicated above.

 

  A. Annual License Maintenance Fee due for this license year $____________

 

B. Less royalties previously paid this license year

 

  (1) January – March $____________  
  (2) April – June $____________  
  (3) July – September $____________  
  (4) October - December $____________  
  (5) Total payments to date               $(_____________)

 

C. REPORT PERIOD    
         
  (1) Units of product sold  ____________  
  (2) Sales price per unit $____________  
  (3) Gross sales of product (1 x 2) $____________  
  (4) Less allowable deductions $( ___________)  
  (5) Net Sales of product sold (3 – 4) $____________  
  (6) Running royalty rate  ____________  
  (7) Royalty payment due this period (5 x 6) $____________            $(______________)

 

(Enclose remittance made payable to Kansas State University Research Foundation)

 

  D. Remaining Annual License Maintenance Fee due: (A – B(5) –C(7)) $  

 

For Office Use Only    
    Authorized Signature
     
    Printed Name, Title
     
Account no. – Disc. no. __________________________    
Check number                 __________________________    
Check date                       __________________________    

 

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Exhibit 31.1

 

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER

 

I, Gary Wilcox, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Cocrystal Pharma, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 13, 2020

 

/s/ Gary Wilcox  
Gary Wilcox  
Chief Executive Officer  
(Principal Executive Officer)  

 

 

 

 

Exhibit 31.2

 

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

 

I, James Martin, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Cocrystal Pharma, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 13, 2020

 

/s/ James Martin  
James Martin  
Chief Financial Officer  
(Principal Financial Officer)  

 

 

 

 

Exhibit 32.1

 

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the quarterly report of Cocrystal Pharma, Inc. (the “Company”) on Form 10-Q for the quarter ended March 31, 2020, as filed with the Securities and Exchange Commission on the date hereof, I, Gary Wilcox, certify, pursuant to 18 U.S.C. Sec.1350, as adopted pursuant to Sec.906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:

 

1. The quarterly report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934 and

 

2. The information contained in the quarterly report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

/s/ Gary Wilcox  
Gary Wilcox  
Chief Executive Officer  
(Principal Executive Officer)  

 

Dated: May 13, 2020

 

In connection with the quarterly report of Cocrystal Pharma, Inc. (the “Company”) on Form 10-Q for the quarter ended March 31, 2020, as filed with the Securities and Exchange Commission on the date hereof, I, James Martin, certify, pursuant to 18 U.S.C. Sec.1350, as adopted pursuant to Sec.906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:

 

1. The quarterly report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934 and

 

2. The information contained in the quarterly report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

/s/ James Martin  
James Martin  
Chief Financial Officer  
(Principal Financial Officer)  

 

Dated: May 13, 2020

 

 

 

v3.20.1
Stock Based Awards - Schedule of Share-based Compensation, Stock Options, Activity (Details) - Stock Option [Member]
3 Months Ended
Mar. 31, 2020
USD ($)
$ / shares
shares
Number of Shares Available for Grant, Beginning 3,588,000
Number of Shares Available for Grant, Exercised
Number of Shares Available for Grant, Granted
Number of Shares Available for Grant, Cancelled 8,000
Number of Shares Available for Grant, Ending 3,596,000
Total Options Outstanding, Beginning 931,000
Total Options Outstanding, Exercised
Total Options Outstanding, Granted
Total Options Outstanding, Cancelled (8,000)
Total Options Outstanding, Ending 923,000
Weighted Average Exercise Price, Outstanding | $ / shares $ 4.14
Weighted Average Exercise Price, Exercised | $ / shares
Weighted Average Exercise Price, Granted | $ / shares
Weighted Average Exercise Price, Cancelled | $ / shares 2.94
Weighted Average Exercise Price, Ending | $ / shares $ 4.15
Aggregate Intrinsic Value, Beginning | $
Aggregate Intrinsic Value, Ending | $
v3.20.1
Licenses and Collaborations (Details Narrative) - USD ($)
$ in Thousands
3 Months Ended
Feb. 18, 2020
Jan. 02, 2019
Mar. 31, 2020
Mar. 31, 2019
Collaboration revenue     $ 461 $ 5,078
Collaboration Agreement [Member]        
Proceeds from collaborators   $ 4,000    
Collaboration Agreement [Member] | Maximum [Member]        
Royalty received on sales   $ 156,000    
License Agreement [Member]        
Non refundable license initiation fee $ 80      
Annual license maintenance fee $ 80      
v3.20.1
Licenses and Collaborations
3 Months Ended
Mar. 31, 2020
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Licenses and Collaborations

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 to discover and develop certain proprietary influenza A/B antiviral agents. Under the terms of the Collaboration Agreement, Merck funds 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.

 

The Company recognized $461,000 in revenues on the condensed consolidated statement of operations and recorded the same amount in accounts receivable on the condensed consolidated balance sheet, for the three months ended and as of March 31, 2020, respectively, related to influenza A/B program research and development expenses for the first quarter of 2020.

  

Kansas State University Research Foundation

 

Cocrystal 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 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 agreed to pay the Foundation a one-time non-refundable license initiation fee of $80,000 under the License Agreement, and annual license maintenance fees. The Company also agreed to make certain future milestone payments, dependent upon the progress of clinical trials, regulatory approvals, and initiation of commercial sales in the United States and certain countries outside the United States. See Note 11, Subsequent Events with respect to another License Agreement with the foundation.

v3.20.1
Accounts Payable and Accrued Expenses
3 Months Ended
Mar. 31, 2020
Payables and Accruals [Abstract]  
Accounts Payable and Accrued Expenses

4. Accounts Payable and Accrued Expenses

 

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

 

    March 31, 2020     December 31, 2019  
Accounts payable   $ 922     $ 1,511  
Accrued compensation     107       83  
Accrued other expenses     630       405  
Total accounts payable and accrued expenses   $ 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.

v3.20.1
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($)
$ in Thousands
Mar. 31, 2020
Dec. 31, 2019
Statement of Financial Position [Abstract]    
Related party operating lease right of use assets $ 40 $ 40
Related party operating lease liabilities current 59 59
Related party operating lease liabilities non-current $ 40 $ 40
Common stock, par value $ 0.001 $ 0.001
Common stock, shares authorized 100,000,000 100,000,000
Common stock, shares issued 52,141,000 35,150,000
Common stock, shares outstanding 52,141,000 35,150,000
v3.20.1
Basis of Presentation and Significant Accounting Policies (Policies)
3 Months Ended
Mar. 31, 2020
Accounting Policies [Abstract]  
Basis of Presentation

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, 2019 filed on March 27, 2020 (“Annual Report”).

Principles of Consolidation

Principles of Consolidation

 

The 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

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

Use of Estimates

 

Preparation of the Company’s 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 consolidated financial statements and accompanying notes. The significant estimates in the Company’s 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.

Concentrations of Credit Risk

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 U.S. financial institutions, which may, at times, exceed federally insured limits of $250,000 for each institution accounts are held. At March 31, 2020 and December 31, 2019, our primary operating account held approximately $21,686,000 and $7,418,000, respectively, and our collateral account balance was $50,000 at a different institution. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risks thereof.

 

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

Fair Value Measurements

Fair Value Measurements

 

FASB Accounting Standards Codification (“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 2 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 7 – Warrants.

 

At March 31, 2020 and December 31, 2019, the carrying amounts of financial 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 based on prevailing market interest rates.

 

The Company’s derivative liabilities are considered Level 2 measurements.

Goodwill

Goodwill

 

In November 2014, goodwill was 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 program 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.

 

At March 31, 2020, the Company had goodwill of $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

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 excess of the carrying amount over the asset’s fair value.

Research and Development Expenses

Research and Development Expenses

 

All research and development costs are expensed as incurred.

Revenue Recognition

Revenue Recognition

 

The Company recognizes revenue from research and development 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 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.

 

The Company recognized revenue for the three months ended March 31, 2020 and 2019 were $461,000 and $5,078,000, respectively. As of March 31, 2020, accounts receivable of $644,000 was due from Merck.

Income Taxes

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.

 

As of March 31, 2020, the Company assessed its income tax expense based on its projected future taxable income for the year ended December 31, 2020 and therefore recorded no amount for income tax expense for the three months ended 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, 2019 for more information.

Stock-Based Compensation

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’s Simplified Method for Estimate Expected Term. The risk-free interest rate is estimated using comparable published federal funds rates.

Share Issuance Costs

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

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

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  

  

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

Recent Accounting Pronouncements

 

In June 2016, the FASB issued ASU No. 2016-13, 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 notes receivables. The standard will replace today’s “incurred loss” approach with an “expected loss” model, under which companies will recognize allowances based on expected rather than incurred losses. Entities will apply the standard’s provisions as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is effective. The standard is effective for interim and annual reporting periods beginning after December 15, 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 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 consolidated financial statements and related disclosures.

v3.20.1
Organization and Business
3 Months Ended
Mar. 31, 2020
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Organization and Business

1. Organization and Business

 

Cocrystal Pharma, Inc. (“we”, the “Company” or “Cocrystal”), a biopharmaceutical company incorporated in Delaware, has been developing novel technologies and approaches to create first-in-class or 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.

 

The Company’s activities since inception have principally consisted of acquiring 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 strategic alliances. Through March 31, 2020, the Company has primarily funded its operations through equity offerings.

v3.20.1
Basis of Presentation and Significant Accounting Policies - Schedule of Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended
Mar. 31, 2020
Mar. 31, 2019
Accounting Policies [Abstract]    
Net income (loss) attributable to common stockholders $ (1,990) $ 2,971
Weighted average number of shares outstanding, basic 41,662,000 30,337,000
Adjustment for dilutive effects of warrants, outstanding and in-the-money 26,000
Adjustment for dilutive effects of options, exercisable and in-the-money 8,000
Weighted average number of common shares outstanding, diluted 41,662,000 30,371,000
Net income (loss) per common share, basic $ (0.05) $ 0.10
Net income (loss) per common share, diluted $ (0.05) $ 0.10
v3.20.1
Stock Based Awards (Tables)
3 Months Ended
Mar. 31, 2020
Equity [Abstract]  
Schedule of Share-based Compensation, Stock Options, Activity

The following table summarizes stock option transactions for the 2007 Plan and 2015 Plan, collectively, for the three months ended 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, 2019     3,588       931     $ 4.14     $             -  
Exercised     -       -       -       -  
Granted     -       -       -       -  
Cancelled     8       (8 )     2.94       -  
Balance at March 31, 2020     3,596       923       4.15       -  

Schedule of Common Stock Reserved Future Issuance

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

 

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

v3.20.1
Basis of Presentation and Significant Accounting Policies - Schedule of Antidilutive Securities Excluded from Calculations of Net Loss Per Share (Details) - shares
3 Months Ended
Mar. 31, 2020
Mar. 31, 2019
Anti-dilutive securities 1,166,000 1,417,000
Stock Option [Member]    
Anti-dilutive securities 923,000 1,200,000
Warrants [Member]    
Anti-dilutive securities 243,000 217,000
Convertible Notes [Member]    
Anti-dilutive securities
v3.20.1
Warrants (Tables)
3 Months Ended
Mar. 31, 2020
Warrants and Rights Note Disclosure [Abstract]  
Summary of Warrant Activity

The following is a summary of activity in the number of warrants outstanding to purchase the Company’s common stock for the three months ended March 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, 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          

Schedule of Fair Value of Warrants Classified as 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 March 31, 2020:

 

    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 December 31, 2019:

 

   

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  

v3.20.1
Subsequent Events (Details Narrative)
$ in Thousands
Apr. 19, 2020
USD ($)
Subsequent Event [Member] | Second License Agreement [Member]  
Annual license maintenance fee $ 110
v3.20.1
Stock Based Awards (Details Narrative) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended
Mar. 31, 2020
Mar. 31, 2019
Shares reserved for issuance 4,762,000 2,467,000
Stock based compensation expense $ 107 $ 33
Unrecognized compensation expense $ 1,072  
Stock-based compensation weighted average period 1 year 4 months 24 days  
Number of options vested and expected to vest 923,065  
Aggregate intrinsic value of vested and expected to vest $ 0  
Weighted-average exercise price $ 4.15  
Weighted-average remaining contractual term 7 years 10 months 3 days  
Number of options vested and exercisable $ 413,690  
Aggregate intrinsic value of options vested and exercisable $ 0  
Weighted-average exercise price of options vested and exercisable $ 5.84  
Weighted-average remaining contractual term of options vested and exercisable 7 years 1 month 6 days  
Shares issued price per share $ 0.71  
2007 Equity Incentive Plans [Member]    
Shares reserved for issuance 1,786,635  
Shares vesting period 10 years  
2015 Equity Incentive Plans [Member]    
Shares reserved for issuance 2,705,237  
Shares vesting period 10 years  
Shares available for grant 3,595,643  
Transferred from 2007 Plans [Member]    
Shares reserved for issuance 1,038,570  
v3.20.1
Warrants - Schedule of Fair Value of Warrants Classified as Liabilities (Details)
3 Months Ended 12 Months Ended
Mar. 31, 2020
$ / shares
Dec. 31, 2019
$ / shares
October 2013 Warrants [Member]    
Strike price $ 15.00 $ 15.00
Value $ 0.20 $ 0.04
October 2013 Warrants [Member] | Expected Dividend Yield [Member]    
Fair value assumptions, percentage 0.00 0.00
January 2014 Warrants [Member]    
Strike price $ 15.00 $ 15.00
Value $ 0.21 $ 0.05
January 2014 Warrants [Member] | Expected Dividend Yield [Member]    
Fair value assumptions, percentage 0.00 0.00
January 2014 Warrants [Member] | Contractual Term [Member]    
Warrant Expected term (years) 3 years 9 months 18 days 4 years
January 2014 Warrants [Member] | Cumulative Volatility [Member]    
Fair value assumptions, percentage 118.41 90.58
January 2014 Warrants [Member] | Risk Free Interest Rate [Member]    
Fair value assumptions, percentage 0.41 1.68
October 2013 Warrants [Member] | Contractual Term [Member]    
Warrant Expected term (years) 3 years 7 months 6 days 3 years 9 months 18 days
October 2013 Warrants [Member] | Cumulative Volatility [Member]    
Fair value assumptions, percentage 120.15 89.59
October 2013 Warrants [Member] | Risk Free Interest Rate [Member]    
Fair value assumptions, percentage 0.39 1.67
v3.20.1
Condensed Consolidated Balance Sheets - USD ($)
$ in Thousands
Mar. 31, 2020
Dec. 31, 2019
Current assets:    
Cash $ 21,686 $ 7,418
Restricted cash 50 50
Accounts receivable 644 644
Prepaid expenses and other current assets 202 169
Total current assets 22,582 8,281
Property and equipment, net 494 431
Deposits 39 50
Operating lease right-of-use assets, net (including $40 to related party) 634 677
Goodwill 19,092 19,092
Total assets 42,841 28,531
Current liabilities:    
Accounts payable and accrued expenses 1,659 1,999
Current maturities of finance lease liabilities 50 103
Current maturities of operating lease liabilities (including $59 to related party) 182 177
Derivative liabilities 34 7
Total current liabilities 1,925 2,286
Long-term liabilities:    
Finance lease liabilities 10 14
Operating lease liabilities (including $40 to related party) 475 523
Total long-term liabilities 485 537
Total liabilities 2,410 2,823
Commitments and contingencies  
Stockholders' equity:    
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 277,628 260,932
Accumulated deficit (237,250) (235,260)
Total stockholders' equity 40,431 25,708
Total liabilities and stockholders' equity $ 42,841 $ 28,531
v3.20.1
Basis of Presentation and Significant Accounting Policies (Tables)
3 Months Ended
Mar. 31, 2020
Accounting Policies [Abstract]  
Schedule of Computation of Basic and Diluted Net Loss Per Share

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  

Schedule of Antidilutive Securities Excluded from Calculations of Net Loss Per Share

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  

v3.20.1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2020
Mar. 31, 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
v3.20.1
Commitments and Contingencies
3 Months Ended
Mar. 31, 2020
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies

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 10 – Transactions with Related Parties). Leases 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 4.5 years.

 

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

 

2020 (excluding the three months ended March 31, 2020)   $ 170  
2021     213  
2022     178  
2023     183  
Thereafter     15  
Total operating lease payments     759  
Less: present value discount     (102 )
         
Total operating lease liabilities   $ 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 three months ended March 31, 2020 and 2019, approximately $20,000 and $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 10 – 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.

 

For the three months ended March 31, 2020 and 2019, operating lease expense, excluding short-term leases, finance leases and CAM charges, totaled approximately $44,000 and $43,000, respectively.

 

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 1.7 years.

 

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

 

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 March 31, 2020, total right-of-use lab equipment and accumulated depreciation recognized under finance leases is $347,000 and $93,000, respectively, and depreciation expense for the three months ended March 31, 2020 was $17,000. As of December 31, 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 $76,000.

 

At 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, was $117,000 and the Company expects to pay future interest charges of $4,000 over the remaining finance lease terms. For the three months ended March 31, 2019, the Company paid $52,000 and $6,000 in principal and interest, respectively, totaling financing cash out flows of $52,000, net of interest expense, for amount included in the measurement of lease liabilities for finance 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, 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. 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. Pepe 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 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.

 

Liberty Insurance Underwriters Inc. filed suit against us in federal court in Delaware seeking a declaratory judgment that it is not liable to defend us in the class 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.

 

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. The plaintiff’s appeal was denied and the 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.

 

COVID-19

 

Our administrative and finance activities are fully functional out of our Miami, 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 continue working remotely and we remain committed to meeting our corporate and development milestones throughout the year. We have experienced delays in our supply chain and with service partners as a result of the COVID-19 pandemic. Also because of the unknown impact from the COVID-19 pandemic, it may have unanticipated material adverse 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.

v3.20.1
Common Stock
3 Months Ended
Mar. 31, 2020
Equity [Abstract]  
Common Stock

5. Common Stock

 

As of March 31, 2020, the Company has authorized 100,000,000 shares of common stock, $0.001 par value per share. The Company had 52,140,699 and 35,150,058 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively.

 

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

 

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 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. In October 2019, the Company and 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 been raised to date).

 

On January 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 29, 2020, the Company entered into a securities purchase agreement with certain institutional investors, pursuant to which the Company agreed to sell and issue, in a registered direct offering, 3,492,063 shares of common stock at a 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 other estimated offering expenses payable by the Company. The Company closed the offering on January 31, 2020.

 

On February 27, 2020, the Company entered into a securities 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 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 a 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 Company of approximately $6.8 million, before deducting fees payable to the placement agent, lock-up settlement fee and other estimated offering expenses payable by the Company. The Company closed the offering on March 10, 2020.

v3.20.1
Basis of Presentation and Significant Accounting Policies (Details Narrative)
$ in Thousands
3 Months Ended
Mar. 31, 2020
USD ($)
Segment
Mar. 31, 2019
USD ($)
Dec. 31, 2019
USD ($)
Number of operating segment | Segment 1    
Primary operating account balance $ 21,686   $ 7,418
Cash uninsured amount 50    
Goodwill 19,092   $ 19,092
Impairment in goodwill   $ 46,103  
Collaboration revenue 461 $ 5,078  
Accounts receivable related party $ 644    
Customer One [Member] | Customer Concentration Risk [Member] | Revenue and Receivables [Member]      
Revenue and receivable percentage 100.00%    
U.S. Financial Institutions One [Member]      
Cash FDIC insured limits $ 250    
U.S. Financial Institutions Two [Member]      
Cash FDIC insured limits $ 250    
v3.20.1
Accounts Payable and Accrued Expenses (Tables)
3 Months Ended
Mar. 31, 2020
Payables and Accruals [Abstract]  
Schedule of Accounts Payable and Accrued Expenses

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

 

    March 31, 2020     December 31, 2019  
Accounts payable   $ 922     $ 1,511  
Accrued compensation     107       83  
Accrued other expenses     630       405  
Total accounts payable and accrued expenses   $ 1,659     $ 1,999  

v3.20.1
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($)
$ in Thousands
Mar. 31, 2020
Dec. 31, 2019
Total property and equipment $ 1,605 $ 1,512
Less: accumulated depreciation and amortization (1,111) (1,081)
Property and equipment, net 494 431
Lab Equipment [Member]    
Total property and equipment 1,138 1,073
Finance Lease Right-of-Use Lab Equipment Obtained in Exchange For Finance Lease Liabilities [Member]    
Total property and equipment 347 347
Computer and Office Equipment [Member]    
Total property and equipment $ 120 $ 92
v3.20.1
Commitments and Contingencies - Schedule of Maturities of Finance Lease (Details) - USD ($)
$ in Thousands
Mar. 31, 2020
Dec. 31, 2019
Commitments and Contingencies Disclosure [Abstract]    
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 $ 117
v3.20.1
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2020
Mar. 31, 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) $ 0.1
Weighted average number of common shares outstanding, basic 41,662,000 30,337,000
Weighted average number of common shares outstanding, diluted 41,662,000 30,371,000
v3.20.1
Subsequent Events
3 Months Ended
Mar. 31, 2020
Subsequent Events [Abstract]  
Subsequent Events

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 agreed to pay the Foundation a one-time non-refundable license initiation fee of $110,000 and annual license maintenance fees. The Company also agreed to make certain future milestone payments, dependent upon the progress of clinical trials, regulatory approvals, and initiation of commercial sales in the United 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.

v3.20.1
Basis of Presentation and Significant Accounting Policies
3 Months Ended
Mar. 31, 2020
Accounting Policies [Abstract]  
Basis of Presentation and Significant Accounting Policies

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, 2019 filed on March 27, 2020 (“Annual Report”).

 

Principles of Consolidation

 

The 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 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 consolidated financial statements and accompanying notes. The significant estimates in the Company’s 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.

  

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 U.S. financial institutions, which may, at times, exceed federally insured limits of $250,000 for each institution accounts are held. At March 31, 2020 and December 31, 2019, our primary operating account held approximately $21,686,000 and $7,418,000, respectively, and our collateral account balance was $50,000 at a different institution. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risks thereof.

 

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

 

Fair Value Measurements

 

FASB Accounting Standards Codification (“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 2 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 7 – Warrants.

 

At March 31, 2020 and December 31, 2019, the carrying amounts of financial 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 based on prevailing market interest rates.

 

The Company’s derivative liabilities are considered Level 2 measurements.

 

Goodwill

 

In November 2014, goodwill was 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 program 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.

 

At March 31, 2020, the Company had goodwill of $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 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. 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 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.

 

The Company recognized revenue for the three months ended March 31, 2020 and 2019 were $461,000 and $5,078,000, respectively. As of March 31, 2020, accounts receivable of $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.

  

As of March 31, 2020, the Company assessed its income tax expense based on its projected future taxable income for the year ended December 31, 2020 and therefore recorded no amount for income tax expense for the three months ended 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, 2019 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’s Simplified Method for Estimate Expected Term. The risk-free interest rate is estimated using comparable published federal funds rates.

 

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  

  

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

 

In June 2016, the FASB issued ASU No. 2016-13, 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 notes receivables. The standard will replace today’s “incurred loss” approach with an “expected loss” model, under which companies will recognize allowances based on expected rather than incurred losses. Entities will apply the standard’s provisions as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is effective. The standard is effective for interim and annual reporting periods beginning after December 15, 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 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 consolidated financial statements and related disclosures.

v3.20.1
Warrants
3 Months Ended
Mar. 31, 2020
Warrants and Rights Note Disclosure [Abstract]  
Warrants

7. Warrants

 

The following is a summary of activity in the number of warrants outstanding to purchase the Company’s common stock for the three months ended March 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, 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 March 31, 2020:

 

    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 December 31, 2019:

 

   

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  

 

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 life assumption is based on the remaining contractual terms of the warrants. The risk-free rate is based on the zero 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.

v3.20.1
Commitments and Contingencies (Details Narrative) - USD ($)
$ in Thousands
1 Months Ended 3 Months Ended 12 Months Ended
Sep. 01, 2018
Nov. 30, 2018
Sep. 30, 2018
Mar. 31, 2020
Mar. 31, 2019
Dec. 31, 2019
Rent expense       $ 0    
Accumulated depreciation           $ 76
Right-of-use assets exchanged for finance lease liabilities           347
Finance lease liabilities current and long-term       60   117
Finance lease interest expense       3    
Operating lease payment       44 $ 27  
Principal and interest related to lease       2 6  
Payments on finance lease liabilities       (57) (52)  
Interest expense, net           $ 4
Litigation expense       $ 1,000    
Dr. Phillip Frost [Member]            
Lease term 3 years   3 years      
Lease termination, description The lease term is three years with an optional three year extension.          
Rent expense $ 58   $ 58      
Operating Leases [Member]            
Operating leases weighted average discount rate       8.00%    
Weighted average remaining operating lease term       4 years 6 months    
Common Area Maintenance [Member]            
Operating variable lease expense       $ 20 16  
Operating lease expense       44 $ 43  
Finance Leases [Member]            
Weighted average finance lease discount rate   8.00%        
Weighted average remaining finance lease term   1 year 8 months 12 days        
Right-of-use lab equipment       347    
Accumulated depreciation       93    
Depreciation expense       $ 17    
February 2019 through January 2024 [Member]            
Lease term       60 months    
February 2019 [Member]            
Lease term       5 years    
Lease termination, description       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.    
Unamortized leasing percentage       8.00%    
May 27, 2020 [Member] | Lease Agreement One [Member]            
Lease term   18 months        
Capital lease payment   $ 18        
November 21, 2021 [Member] | Lease Agreement Two [Member]            
Lease term   36 months        
Capital lease payment   $ 1        
Miami, Florida [Member]            
Lease expire       Aug. 31, 2021    
Bothell, Washington [Member]            
Lease expire       Jan. 31, 2024    
v3.20.1
Accounts Payable and Accrued Expenses - Schedule of Accounts Payable and Accrued Expenses (Details) - USD ($)
$ in Thousands
Mar. 31, 2020
Dec. 31, 2019
Payables and Accruals [Abstract]    
Accounts payable $ 922 $ 1,511
Accrued compensation 107 83
Accrued other expenses 630 405
Total accounts payable and accrued expenses $ 1,659 $ 1,999
v3.20.1
Stock Based Awards - Schedule of Common Stock Reserved Future Issuance (Details) - USD ($)
Mar. 31, 2020
Mar. 31, 2019
Share-based Payment Arrangement [Abstract]    
Stock options issued and outstanding 923,000 1,208,000
Shares authorized for future option grants 3,596,000 1,016,000
Convertible notes
Warrants outstanding 243,000 243,000
Total 4,762,000 2,467,000
v3.20.1
Transactions with Related Parties
3 Months Ended
Mar. 31, 2020
Related Party Transactions [Abstract]  
Transactions with Related Parties

10. Transactions with Related Parties

 

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 $14,000 and $14,000 for the three months ended March 31, 2020 and 2019, respectively.

v3.20.1
Property and Equipment
3 Months Ended
Mar. 31, 2020
Property, Plant and Equipment [Abstract]  
Property and Equipment

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 March 31, 2020, and December 31, 2019, property and equipment consists of (in thousands):

 

    March 31, 2020     December 31, 2019  
Lab equipment (excluding equipment under finance leases)   $ 1,138     $ 1,073  
Finance lease right-of-use lab equipment obtained in exchange for finance lease liabilities     347       347  
Computer and office equipment     120       92  
Total property and equipment     1,605       1,512  
Less: accumulated depreciation and amortization     (1,111 )     (1,081 )
Property and equipment, net   $ 494     $ 431  

 

Total depreciation and amortization expense were $30,000 and $23,000 for the three months ended March 31, 2020 and 2019 respectively, which includes amortization expense of $17,000 for both years. For additional finance leases information, refer to Note 9 – Commitments and Contingencies.

v3.20.1
Stock Based Awards
3 Months Ended
Mar. 31, 2020
Share-based Payment Arrangement [Abstract]  
Stock Based Awards

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 2,705,237 (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 March 31, 2020, 3,595,643 options remain available for future grants under the 2015 Plan.

  

The following table summarizes stock option transactions for the 2007 Plan and 2015 Plan, collectively, for the three months ended 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, 2019     3,588       931     $ 4.14     $             -  
Exercised     -       -       -       -  
Granted     -       -       -       -  
Cancelled     8       (8 )     2.94       -  
Balance at March 31, 2020     3,596       923       4.15       -  

 

The Company did not grant any options during the three months ended March 31, 2020, nor the three months ended 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 months ended March 31, 2020 and 2019, equity-based compensation expense recorded was $107,000 and $33,000, respectively.

 

As of March 31, 2020, there was approximately $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 1.4 years. For options granted and outstanding, there were 923,065 options outstanding which were fully vested or expected to vest, with an aggregate intrinsic value of $0, a weighted average exercise price of $4.15, and weighted average remaining contractual term of 7.84 years at March 31, 2020. For vested and exercisable options, outstanding shares totaled 413,690, with an aggregate intrinsic value of $0. These options had a weighted average exercise price of $5.84 per share and a weighted-average remaining contractual term of 7.1 years at March 31, 2020.

 

The aggregate intrinsic value of outstanding and exercisable options at March 31, 2020 was calculated based on the closing price of the Company’s common stock as reported on The Nasdaq Capital Market on March 31, 2020 of $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:

 

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

v3.20.1
Document and Entity Information - shares
3 Months Ended
Mar. 31, 2020
May 13, 2020
Document And Entity Information    
Entity Registrant Name Cocrystal Pharma, Inc.  
Entity Central Index Key 0001412486  
Document Type 10-Q  
Document Period End Date Mar. 31, 2020  
Amendment Flag false  
Current Fiscal Year End Date --12-31  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business Flag true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   52,140,699
Document Fiscal Period Focus Q1  
Document Fiscal Year Focus 2020  
v3.20.1
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($)
$ in Thousands
Common Stock [Member]
Additional Paid-in Capital [Member]
Accumulated Deficit [Member]
Total
Balance at Dec. 31, 2018 $ 30 $ 253,949 $ (187,091) $ 66,888
Balance, shares at Dec. 31, 2018 29,938,000      
Stock-based compensation 33 33
Sale of common stock, net of transaction costs $ 2 3,926 3,928
Sale of common stock, net of transaction costs, shares 1,682,000      
Net loss 2,971 2,971
Balance at Mar. 31, 2019 $ 32 257,908 (184,120) 73,820
Balance, shares at Mar. 31, 2019 31,620,000      
Balance at Dec. 31, 2019 $ 36 260,932 (235,260) 25,708
Balance, shares at Dec. 31, 2019 35,150,000      
Stock-based compensation 107 107
Sale of common stock, net of transaction costs $ 17 16,589 16,606
Sale of common stock, net of transaction costs, shares 16,991,000      
Net loss (1,990) (1,990)
Balance at Mar. 31, 2020 $ 53 $ 277,628 $ (237,250) $ 40,431
Balance, shares at Mar. 31, 2020 52,141,000      
v3.20.1
Common Stock (Details Narrative) - USD ($)
1 Months Ended 3 Months Ended
Mar. 09, 2020
Feb. 27, 2020
Jan. 29, 2020
Jan. 28, 2020
Oct. 31, 2019
Oct. 30, 2019
Jan. 31, 2019
Mar. 31, 2020
Dec. 31, 2019
Common stock authorized               100,000,000 100,000,000
Common stock par value               $ 0.001 $ 0.001
Common stock issued               52,141,000 35,150,000
Common stock outstanding               52,141,000 35,150,000
Common stock, voting rights               The holders of common stock are entitled to one vote for each share of common stock held.  
Proceeds from sale of common stock     $ 351,576            
Institutional Investors [Member]                  
Proceeds from sale of common stock $ 6,800,000 $ 11,000,000 $ 2,200,000            
Number of shares issued 5,037,038 8,461,540 3,492,063            
Sale of stock price per share $ 1.35 $ 1.30 $ 0.63            
Equity Distribution Agreement [Member]                  
Sale of common stock, net of transaction costs             80,000    
Proceeds from sale of common stock     $ 551,576 $ 6,000,000 $ 351,576   $ 344,000    
Equity Distribution Agreement [Member] | Amended and Restated [Member]                  
Proceeds from sale of common stock         $ 6,000,000 $ 10,000,000      
v3.20.1
Warrants - Summary of Warrant Activity (Details)
3 Months Ended
Mar. 31, 2020
shares
Number of warrants outstanding, ending 3,596,000
Warrants [Member]  
Number of warrants outstanding, beginning 243,000
Number of warrants exercised
Number of warrants granted
Number of warrants expired
Number of warrants outstanding, ending 243,000
May 2018 Warrants [Member] | Equity [Member]  
Number of warrants outstanding, beginning 84,000
Number of warrants exercised
Number of warrants granted
Number of warrants expired
Number of warrants outstanding, ending 84,000
Warrant expiration date Oct. 27, 2022
October 2013 Warrants [Member] | Liabilities [Member]  
Number of warrants outstanding, beginning 26,000
Number of warrants exercised
Number of warrants granted
Number of warrants expired
Number of warrants outstanding, ending 26,000
Warrant expiration date Oct. 24, 2023
January 2014 Warrants [Member] | Liabilities [Member]  
Number of warrants outstanding, beginning 133,000
Number of warrants exercised
Number of warrants granted
Number of warrants expired
Number of warrants outstanding, ending 133,000
Warrant expiration date Jan. 16, 2024
v3.20.1
Commitments and Contingencies - Schedule of Maturities of Lease Liabilities (Details)
$ in Thousands
Mar. 31, 2020
USD ($)
Commitments and Contingencies Disclosure [Abstract]  
2020 (excluding the three months ended March 31, 2020) $ 170
2021 213
2022 178
2023 183
Thereafter 15
Total operating lease payments 759
Less: present value discount (102)
Total operating lease liabilities $ 657
v3.20.1
Property and Equipment (Details Narrative) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2020
Mar. 31, 2019
Depreciation and amortization expense $ 30 $ 23
Amortization expense $ 17  
Minimum [Member]    
Estimated useful lives 3 years  
Maximum [Member]    
Estimated useful lives 5 years  
v3.20.1
Commitments and Contingencies (Tables)
3 Months Ended
Mar. 31, 2020
Commitments and Contingencies Disclosure [Abstract]  
Schedule of Maturities of Lease Liabilities

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

 

2020 (excluding the three months ended March 31, 2020)   $ 170  
2021     213  
2022     178  
2023     183  
Thereafter     15  
Total operating lease payments     759  
Less: present value discount     (102 )
         
Total operating lease liabilities   $ 657  

Schedule of Maturities of Finance Lease

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

 

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  

v3.20.1
Property and Equipment (Tables)
3 Months Ended
Mar. 31, 2020
Property, Plant and Equipment [Abstract]  
Schedule of Property and Equipment

As of March 31, 2020, and December 31, 2019, property and equipment consists of (in thousands):

 

    March 31, 2020     December 31, 2019  
Lab equipment (excluding equipment under finance leases)   $ 1,138     $ 1,073  
Finance lease right-of-use lab equipment obtained in exchange for finance lease liabilities     347       347  
Computer and office equipment     120       92  
Total property and equipment     1,605       1,512  
Less: accumulated depreciation and amortization     (1,111 )     (1,081 )
Property and equipment, net   $ 494     $ 431  

v3.20.1
Transactions with Related Parties (Details Narrative) - USD ($)
$ in Thousands
1 Months Ended 3 Months Ended
Sep. 01, 2018
Sep. 30, 2018
Mar. 31, 2020
Mar. 31, 2019
Rent expenses     $ 0  
Lease deposit     $ 14 $ 14
Dr. Phillip Frost [Member]        
Lease term 3 years 3 years    
Rent expenses $ 58 $ 58    
Lease deposit   $ 4