UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

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

 

For the quarterly period ended March 31,September 30, 2023

 

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: 877-262-7123

 

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 ☒ 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 ☒ No ☐

 

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

 

Large accelerated filerAccelerated filer
    
Non-accelerated filerSmaller reporting company
    
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

 

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 12,November 13, 2023, the number of outstanding shares of the registrant’s common stock, par value $0.001 per share, was approximately 10,173,790.

 

 

 

 

 

COCRYSTAL PHARMA, INC.

 

FORM 10-Q FOR THE QUARTER ENDED March 31,SEPTEMBER 30, 2023

 

INDEX

 

Part I - FINANCIAL INFORMATION 
Item 1. 
Condensed Consolidated Balance SheetsF-1
Condensed Consolidated Statements of OperationsF-2
Condensed Consolidated Statements of Stockholders’ EquityF-3
Condensed Consolidated Statements of Cash FlowsF-4
Notes to the Condensed Consolidated Financial StatementsF-5
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations3
Item 3. Quantitative and Qualitative Disclosures About Market Risk7
Item 4. Controls and Procedures7
Part II - OTHER INFORMATION 
Item 1. Legal Proceedings8
Item 1. A. Risk Factors8
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds8
Item 3. Defaults Upon Senior Securities8
Item 4. Mine Safety Disclosures8
Item 5. Other Information8
Item 6. Exhibits9
SIGNATURES10

 

2

 

Part I – FINANCIAL INFORMATION

 

COCRYSTAL PHARMA, INC.

 

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except per share data)

 

 March 31,
2023
 December 31,
2022
  September 30, 2023 December 31, 2022 
 (unaudited)    (unaudited)   
Assets                
Current assets:                
Cash $33,981  $37,144  $29,738  $37,144 
Restricted cash  75   75   75   75 
Tax credit receivable  956   716   550   716 
Prepaid expenses and other current assets  2,224   2,243   1,842   2,243 
Total current assets  37,236   40,178   32,205   40,178 
Property and equipment, net  338   342   252   342 
Deposits  46   46   46   46 
Operating lease right-of-use assets, net (including $87 and $99 respectively, to related party)  221   274 
Operating lease right-of-use assets, net (including $57 and $99 respectively, to related party)  111   274 
Total assets $37,841  $40,840  $32,614  $40,840 
                
Liabilities and stockholders’ equity                
Current liabilities:                
Accounts payable and accrued expenses $2,937  $976  $1,806  $976 
Current maturities of finance lease liabilities  -   7   -   7 
Current maturities of operating lease liabilities (including $60 and $59 respectively, to related party)  208   233 
Current maturities of operating lease liabilities (including $57 and $59 respectively, to related party)  118   233 
Total current liabilities  3,145   1,216   1,924   1,216 
Long-term liabilities:                
                
Operating lease liabilities (including $26 and 42 respectively, to related party)  27   57 
Total long-term liabilities  27   57 
Operating lease liabilities (including $0 and $42 respectively, to related party)  -   57 
        
Total liabilities  3,172   1,273   1,924   1,273 
                
Commitments and contingencies  -   - 
Commitments and contingencies (Note 9)  -   - 
                
Stockholders’ equity:                
Common stock, $0.001 par value; 150,000 shares authorized as of March 31, 2023, and December 31, 2022; 8,143 shares issued and outstanding as of March 31, 2023 and December 31, 2022  8   8 
Common stock, $0.001 par value 150,000 shares authorized as of September 30, 2023, and December 31, 2022; 10,174 and 8,143 shares issued and outstanding as of September 30, 2023 and December 31, 2022  10   8 
Additional paid-in capital  337,780   337,489   342,130   337,489 
Accumulated deficit  (303,119)  (297,930)  (311,450)  (297,930)
Total stockholders’ equity  34,669   39,567   30,690   39,567 
Total liabilities and stockholders’ equity $37,841  $40,840  $32,614  $40,840 

 

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)

 2023 2022  2023 2022 2023 2022 
 Three months ended
March 31,
  Three months ended September 30, Nine months ended September 30, 
 2023 2022  2023 2022 2023 2022 
Operating expenses:                        
Research and development  3,907   2,872   4,194   3,872   10,902   9,105 
General and administrative  1,204   1,333   1,849   1,822   4,591   4,530 
Legal settlement  (1,600)  -   (1,600)  1,600 
Impairments  -   -   -   19,092 
Total operating expenses  5,111   4,205   4,443   5,694   13,893   34,327 
                        
Loss from operations  (5,111)  (4,205)  (4,443)  (5,694)  (13,893)  (34,327)
Other (expense) income:        
Interest expense, net  -   (1)
Other income (expense):                
Interest income (expense), net  320   (1)  460   (2)
Foreign exchange loss  (78)  (13)  (42)  (5)  (87)  (19)
Change in fair value of derivative liabilities  -   11   -   -   -   12 
Total other (expense) income, net  (78)  (3)
Total other expense, net  278   (6)  373   (9)
Net loss $(5,189) $(4,208) $(4,165) $(5,700)  (13,520)  (34,336)
Net loss per common share, basic and diluted $(0.64) $(0.52) $(.41) $(0.70)  (1.43)  (4.23)
Weighted average number of common shares outstanding, basic and diluted  8,143   8,143 
Weighted average number of common shares, basic and diluted  10,153   8,143   9,461   8,143 

 

See accompanying notes to condensed consolidated financial statements.

 

F-2

 

 

COCRYSTAL PHARMA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(unaudited)

(in thousands)

 

 Shares Amount Capital Deficit Equity  Shares Amount Capital Deficit Equity 
 Common Stock Additional
Paid-in
 Accumulated Total
Stockholders’
  Common Stock Additional
Paid-in
 Accumulated Total
Stockholders’
 
 Shares Amount Capital Deficit Equity  Shares Amount Capital Deficit Equity 
Balance as of December 31, 2022  8,143  $8  $337,489  $(297,930) $39,567   8,143  $    8  $337,489  $(297,930) $           39,567 
Stock-based compensation  -   -   291   -   291   -   -   291   -   291 
Net loss  -   -   -   (5,189)  (5,189)  -   -   -   (5,189)  (5,189)
Balance as of March 31, 2023  8,143  $8,143  $337,780  $(303,119) $34,669   8,143  $8  $337,780  $(303,119) $34,669 
Stock-based compensation  -   -   179   -   179 
Sale of common stock to related entities, net of transaction costs  2,031   2   3,998   -   4,000 
Net loss  -   -   -   (4,166)  (4,166)
Balance as of June 30, 2023  10,174  $10  $341,957  $(307,285) $34,682 
Stock-based compensation  -   -   173   -   173 
Net loss  -   -   -   (4,165)  (4,165)
Balance as of September 30, 2023  10,174  $10  $342,130  $(311,450) $30,690 

 

 Common Stock Additional
Paid-in
 Accumulated Total
Stockholders’
  Common Stock Additional
Paid-in
 Accumulated Total
Stockholders’
 
 Shares Amount Capital Deficit Equity  Shares Amount Capital Deficit Equity 
Balance as of December 31, 2021  8,143  $8  $336,544  $(259,093) $77,549   8,143  $    8  $336,544  $(259,093) $            77,549 
Stock-based compensation  -   -   239   -   239   -   -   239   -   239 
Net loss  -   -   -   (4,208)  (4,208)  -   -   -   (4,208)  (4,208)
Balance as of March 31, 2022  8,143  $8  $336,783  $(263,301) $73,580   8,143  $8  $336,783  $(263,301) $73,580 
Stock-based compensation  -   -   241   -   241 
Net loss  -   -   -   (24,428)  (24,428)
Balance as of June 30, 2022  8,143  $8  $337,114  $(287,729) $49,393 
Stock-based compensation  -   -   216   -   216 
Net loss  -   -   -   (5,700)  (5,700)
Balance as of September 30, 2022  8,143  $8  $337,330  $(293,429) $49,909 

 

See accompanying notes to condensed consolidated financial statements.

F-3

 

COCRYSTAL PHARMA, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)

 

 2023 2022  2023 2022 
 Three months ended
March 31,
  Nine months ended September 30, 
 2023 2022  2023 2022 
Operating activities:                
Net loss $(5,189) $(4,208) $(13,520) $(34,336)
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation and amortization expense  49   46   149   137 
Amortization of right of use assets  54   49   163   151 
Loss on impairment of goodwill  -   19,092 
Stock-based compensation  291   239   643   696 
Payments on operating lease liabilities  (56)  (50)  (172)  (154)
Change in fair value of derivative liabilities  -   (11)  -   (12)
Changes in operating assets and liabilities:                
Prepaid expenses and other current assets  19   8   401   (2,197)
Tax credit receivable  (240)  -   166   - 
Accounts payable and accrued expenses  1,961   17   830   81 
        
Net cash used in operating activities  (3,111)  (3,910)  (11,340)  (16,542)
                
Investing activities:                
Purchases of property and equipment  (45)  -   (59)  (62)
Net cash used in investing activities  (45)  -   (59)  (62)
                
Financing activities:                
Payments on finance lease liabilities  (7)  (6)  (7)  (20)
Proceeds from sale of common stock to related entities, net of transaction costs  4,000   - 
Net cash provided by (used in) financing activities  (7)  (6)  3,993   (20)
                
Net increase (decrease) in cash and restricted cash  (3,163)  (3,916)
Net decrease in cash and restricted cash  (7,406)  (16,624)
Cash and restricted cash at beginning of period  37,219   58,755   37,219   58,705 
Cash and restricted cash at end of period $34,056  $54,839  $29,813  $42,131 

 

See accompanying notes to condensed consolidated financial statements.

 

F-4

 

 

COCRYSTAL PHARMA, INC.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited)

 

1. Organization and Business

 

Cocrystal Pharma, Inc. (“we”, the “Company” or “Cocrystal”), a clinical stage biopharmaceutical company incorporated in Delaware, has been developing novel technologies and approaches to create first-in-class or best-in-class antiviral drug candidates since its initial funding in 2008.candidates. 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,September 30, 2023, the Company has primarily funded its operations through equity offerings.

 

In September 2021, the Company opened a wholly owned foreign subsidiary in Australia named Cocrystal Pharma Australia, Ltd (“Cocrystal Australia”) with the objective of operating clinical trials in Australia.

 

On September 27, 2022, the Company filed a Certificate of Amendment to the Certificate of Incorporation (the “Amendment”) with the Delaware Secretary of State to effect a reverse stock split of all outstanding shares of the Company’s common stock at a ratio of one-for-12. At the Company’s 2022 Annual Meeting of Stockholders, holders of a majority of the outstanding voting power approved an amendment to the Certificate of Incorporation of the Company to effect a reverse stock split of all outstanding shares of our common stock at a ratio to be determined by the Board of Directors within a range of one-for-four through one-for-12. Following such approval, Thethe Board of Directors determined to effect the reverse stock split at the ratio of one-for-12. The Amendment became effective October 11, 2022 and the effect of the reverse stock split was reflected on the Nasdaq Stock Market.

 

All share and per share amounts have been retroactively restated to reflect the one-for-12 stock split as if it occurred at the beginning of the earliest period presented.

 

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 U.S. GAAP 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, 2022 filed on March 29, 2023 (“Annual Report”).

 

F-5

Principles of Consolidation

 

The consolidated financial statements include the accounts of Cocrystal Pharma, Inc. and its wholly owned subsidiaries: Cocrystal Discovery, Inc., Cocrystal Pharma Australia Pty Ltd., RFS Pharma, LLC and Cocrystal Merger Sub, Inc. Intercompany transactions and balances have been eliminated.

 

F-5

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 derivativewarrant liabilities, recoverability of deferred tax assets, estimated tax credit receivable and estimated useful lives of fixed assets. 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 twothree U.S. financial institutions, which may, at times, exceed federally insured limits of $250,000 for each institution where accounts are held. At March 31,September 30, 2023 and December 31, 2022, our primarytwo operating accounts held approximately $33,981,00029,738,000 and $37,144,000, respectively, and our collateral account balance was $75,000 and $75,000 at a different institution. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risks thereof.

 

Foreign Currency Transactions

 

The Company and its subsidiaries use the U.S. dollar as functional currency. Foreign currency transactions are initially measured and recorded in the functional currency using the exchange rate on the date of the transaction. Foreign exchange gains and losses arising from settlement of foreign currency transactions are recognized in profit and loss.

 

Cocrystal Australia maintains its records in Australian dollars. The monetary assets and liabilities of Cocrystal Australia are remeasured into the functional currency using the closing rate at the end of every reporting period. All nonmonetary assets and liabilities and related profit and loss accounts are remeasured into the functional currency using the historical exchange rates. Profit and loss accounts, other than those that are remeasured using the historical exchange rates, are remeasured into the functional currency using the average exchange rate for the period. Foreign exchange gains and losses arising from the remeasurement into the functional currency is recognized in profit and loss.

 

Fair Value Measurements

 

FASB Accounting Standards Codification (“ASC”) 820 defines fair value, establishes a framework for measuring fair value under U.S. GAAP 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.

 

F-6

 

 

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,September 30, 2023 and December 31, 2022, 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 leases 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 3 measurements.

 

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 costs consist primarily of fees paid to consultants and outside service providers, and other expenses relating to the acquisition, design, development and testing of the Company’s clinical products. All research and development costs are expensed as incurred. Research and development costs are presented net of tax credits.

 

The Company’s Australian subsidiary is entitled to receive government assistance in the form of refundable and non-refundable research and development tax credits from the federal and provincial taxation authorities, based on qualifying expenditures incurred during the fiscal year. The refundable credits are from the provincial taxation authorities and are not dependent on its ongoing tax status or tax position and accordingly are not considered part of income taxes. The Company records refundable tax credits as a reduction of research and development expenses when the Company can reasonably estimate the amounts and it is more likely than not, they will be received. During the year ended December 31, 2022, the Company recorded tax credits of $805,000 as a reduction of research and development expense,, of which approximately $716,000 was recorded as tax credit receivable as of the year then ended. The Company recorded an accrued tax credit receivable of $240,000550,000 for the threenine months ended March 31, 2023September 30, 2023; and collected approximately $,716,000 of tax credit receivable previously recorded, resulting in a tax credit receivable of $956,000550,000 at March 31, 2023.September 30, 2023.

 

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,September 30, 2023, the Company assessed its income tax expense based on its projected future taxable income for the year ending December 31, 2023 and therefore recorded no amount for income tax expense for the threenine months ended March 31,September 30, 2023. 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, 2022 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 SEC Staff Bulletin No. 107’s Simplified Method for Estimate Expected Term. The risk-free interest rate is estimated using comparable published federal funds rates.

 

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

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

  2023  2022 
  September 30, 
  2023  2022 
Outstanding options to purchase common stock  559   350 
Warrants to purchase common stock  13   20 
Total  572   370 

       
  March 31, 
  2023  2022 
Outstanding options to purchase common stock  350   206 
Warrants to purchase common stock  13   20 
Total  363   226 

F-8

 

Recent Accounting Pronouncements

 

Authoritative guidance issued by the FASB (including technical corrections to the ASC), the American Institute of Certified Public Accountants, and the 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,September 30, 2023, and December 31, 2022, property and equipment consists of (in(table in thousands):

Schedule of Property and Equipment

 March 31, 2023 December 31, 2022  September 30, 2023 December 31, 2022 
Lab equipment $1,675  $1,631  $1,708  $1,631 
Finance lease right-of-use lab equipment  194   194   162   194 
Computer and office equipment  131   131   145   131 
Total property and equipment  2,000   1,956   2,015   1,956 
Less: accumulated depreciation and amortization  1,662   (1,614)  (1,763)  (1,614)
Property and equipment, net $338  $342  $252  $342 

 

Total depreciation and amortization expense were approximately $49,000149,000 and $46,000137,000 for the three nine months ended March 31,September 30, 2023 and 2022, which includes amortization expense of $1,0007,164 and $4,00020,000 for the threenine months ended March 31,September 30, 2023 and 2022, respectively, related to assets under finance lease. 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:

 

Schedule of Accounts Payable and Accrued Expenses

 March 31, 2023 December 31, 2022  September 30, 2023 December 31, 2022 
Accounts payable $2,654  $614  $568  $614 
Accrued compensation  131   130   173   130 
Accrued other expenses  152   232   1,065   232 
Total accounts payable and accrued expenses $2,937  $976  $1,806  $976 

 

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

 

The Company has 150,000,000 shares of common stock, $0.001 par value per share, authorized as of March 31,September 30, 2023, and December 31, 2022. The Company had 10,174,000 and 8,143,3328,143,000 shares issued and outstanding as of March 31,September 30, 2023, and December 31, 2022. The holders of common stock are entitled to one vote for each share of common stock held.

On April 4, 2023, the Company entered into a Securities Purchase Agreement with two accredited investors that are related entities (the “Purchasers”) pursuant to which the Purchasers purchased a total of 2,030,458 shares of common stock at a price of $1.97 per share for a total purchase price of $4,000,000 in two equal $2,000,000 investments in an unregistered offering exempt from registration pursuant to Section 4(a)(2) of the Securities Act of 1933 and Rule 506(b) promulgated thereunder (see Note 10).

F-9

 

6. Stock Based Awards

 

Equity Incentive Plans

 

The Company adopted an equity incentive plan in 2007 (the “2007 Plan”). The 2007 Plan has expired and the Company no longer issues any awards under the 2007 Plan. As of March 31, 2023, there is 0 of outstanding incentive stock options granted under the 2007 Plan that 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 833,333 shares of common stock have been reserved for issuance to employees, and nonemployeenon-employee 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. On June 16, 2021, the Company’s stockholders voted to approve an amendment to the 2015 Plan to increase the number of shares of common stock authorized for issuance under the 2015 Plan from 416,667 to 833,333 shares. As of March 31,September 30, 2023, 484,000274,599 shares remain available for future grants under the 2015 Plan.

 

In July 2022, the Compensation Committee of the Company’s Board of Directors granted a total of 158,012 stock options with a fair value of $633,000 effective as of July 26, 2022. The Company granted the stock options to directors, executives, employees, and consultants. The options are ten-year incentive stock options exercisable at $0.42 per share and vesting as follows: one-half vested on the one-year anniversary of the grant date and the remainder vest in eight equal quarterly instalments on the last day of March, June, September and December, with the first such quarterly instalment having vested on September 30, 2023.

In July 2023, the Compensation Committee of the Company’s Board of Directors granted a total of 209,216 stock options with a fair value of $470,000 effective as of July 18, 2023. The Company granted stock options to directors, executives, employees, and consultants. The options are ten-year incentive stock options exercisable at $2.67 per share and vesting as follows: one-half vest on the one-year anniversary of the grant date and the remainder vest in eight equal quarterly instalments on the last day of March, 31, 2023June, September and December, with the first such quarterly installment vesting on September 30, 2024.

 

The following table summarizes stock option transactions for the 2007 Plan and 2015 Plan, collectively, for the threenine months ended March 31,September 30, 2023 (in thousands, except per share amounts):

Schedule of Share-based Compensation, Stock Options, Activity

 Number of
Shares
Available
for Grant
 Total
Options
Outstanding
 Weighted
Average
Exercise
Price
 Aggregate
Intrinsic
Value
  Number of
Shares
Available
for Grant
 Total
Options
Outstanding
 Weighted
Average
Exercise
Price
 Aggregate
Intrinsic
Value
 
Balance at December 31, 2022  484   350  $15.03  $0.00   484   350  $14.98  $0.00 
Increase in authorized options  -   -   -   -   -   -   -   - 
Exercised  -   -   -   -   -   -   -   - 
Granted  -   -   -   -   (209)  209   2.67   - 
Expired  -   -   -   -   -   -   -   - 
Cancelled  -   -   -   -   -   -   -   - 
Balance at March 31, 2023  484   350  $14.98  $0.00 
Balance at September 30, 2023  275   559  $10.37  $- 

 

The Company accounts for share-based awards to employees and nonemployee 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. During the period ended March 31, 2023, the Company did not grant any stock options. For the three and nine months ended March 31,September 30, 2023 and 2022, equity-based compensation expense recorded was $291,000173,000 and $239,000643,000 and $216,000 and $696,000 respectively.

 

F-10

 

 

The fair value of share option award is estimated using the Black-Scholes option pricing method based on the following weighted-average assumptions:

Schedule of Share-based Compensation, Stock Options, ActivityAssumption

 2023 2022  2023 2022 
 Three Months Ended March 31,  Nine Months Ended September 30, 
 2023 2022  2023 2022 
          
Risk-Free interest rate  1.64%  1.04%  2.33%  1.64%
Expected dividend yield  0.00%  0.00%  0.00%  0.00%
Expected volatility  87.81%  76.24%  95.08%  87.81%
Expected term (in years)  4.81   4.33   5.10   4.8 

 

As of March 31,September 30, 2023, there was approximately $761,000879,000 of total unrecognized compensation expense related to non-vested stock options that is expected to be recognized over a weighted average period of 1.01.1 years. For options granted and outstanding, there were 350,000559,000 options outstanding which were fully vested or expected to vest, with an aggregate intrinsic value of $0.00, a weighted average exercise price of $14.9810.37 and weighted average remaining contractual term of 8.28.47 years at March 31,September 30, 2023. For vested and exercisable options, outstanding shares totaled 161,000264,000, with an aggregate intrinsic value of $0.00. These options had a weighted average exercise price of $19.9917.68 per share and a weighted-average remaining contractual term of 7.07.37 years at March 31,September 30, 2023.

 

The aggregate intrinsic value of outstanding and exercisable options at March 31,September 30, 2023 was calculated based on the closing price of the Company’s common stock as reported on The Nasdaq Capital Market on March 31,September 30, 2023 of $1.991.87 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:

Schedule of Common Stock Reserved for Future Issuance

     
 March 31, 2023 March 31, 2022  September 30, 2023 September 30, 2022 
Stock options issued and outstanding  350   206   558   350 
Shares authorized for future option grants  484   629   275   484 
Warrants outstanding  13   20   13   20 
Total  847   855   846   854 

 

7. Warrants

 

The following is a summary of activity in the number of warrants outstanding to purchase the Company’s common stock for the threenine months ended March 31,September 30, 2023 (in thousands):

Summary of Warrant Activity

 

Warrants

Accounted for as: Equity

 

Warrants

Accounted for as:

Liabilities

    

Warrants

Accounted for as: Equity

 

Warrants

Accounted for as:

Liabilities

   
 May 2018
Warrants
 October 2013
Warrants
 January 2014
Warrants
 Total  May 2018
Warrants
 October 2013
Warrants
 January 2014
Warrants
 Total 
Outstanding, December 31, 2022  -   2   11   13        -   2   11   13 
Exercised  -   -   -   -   -   -   -   - 
Granted  -   -   -   -   -   -   -   - 
Expired  -   -   -   -   -   -   -   - 
Outstanding, March 31, 2023  -   2   11   13 
Outstanding, September 30, 2023  -   2   11   13 
Expiration date:  -   -   -       -   10/24/2023   01/16/2024   - 

 

F-11

Warrants Classified as Liabilities

 

Liability-classified warrants consist of warrants issued by Biozone Pharmaceuticals, Inc. (“Biozone”), the company’sCompany’s predecessor, in connection with an equity financingsfinancing in October 2013 which were assumed by the Company in connection with its merger with Biozone in January 2014 and warrants issued by the Company 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.

F-11

 

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,September 30, 2023:

Schedule of Fair Value of Warrants Classified as Liabilities

 October 2013
Warrants
 January 2014
Warrants
  October 2013
Warrants
 January 2014
Warrants
 
          
Strike price $180.00  $180.00  $180.00  $180.00 
Expected dividend yield  0.00%  0.00%  0.00%  0.00%
Contractual term (years)  0.6   0.8   0.1   0.3 
Cumulative volatility  139.18%  140.98%  133.64%  134.93%
Risk-free rate  4.10%  4.07%  4.93%  4.89%
Value per warrants $0  $0  $0.00  $0.00 
Fair value (in thousands) $0  $0  $0.00  $0.00 

 

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, 2022:

 

 October 2013
Warrants
 January 2014
Warrants
  October 2013
Warrants
 January 2014
Warrants
 
          
Strike price $180.00  $180.00  $180.00  $180.00 
Expected dividend yield  0.00%  0.00%  0.00%  0.00%
Expected term (years)  0.8   1.0   0.8   1.0 
Cumulative volatility  143.06%  145.00%  143.06%  145.00%
Risk-free rate  4.42%  4.40%  4.42%  4.40%
Fair value (in thousands) $-  $-  $0.00  $0.00 

 

The Company estimates volatility using its own historical stock price volatility. 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 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.

 

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 Norovirusnorovirus and Coronaviruscoronavirus 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.

 

9. Commitments and Contingencies

 

Commitments

In the ordinary course of business, the Company enters into non-cancellable 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 research and development laboratory space in Bothell, Washington under operating leases that expire on August 31, 2024 and January 31, 2024, respectively. For operating leases, the weighted average discount rate is 7.16.8% and the weighted average remaining lease term is 1.50.6 years.

 

The following table summarizes the Company’s maturities of operating lease liabilities, by year and in aggregate, as of March 31,September 30, 2023 (in(table in thousands):

Schedule of Maturities of Operating Lease Liabilities

        
2023 (excluding the three months ended March 31, 2023) $185 
2023 (excluding the nine months ended September 30, 2023) $62 
2024  58   58 
2025  -   - 
Thereafter  -   - 
Total operating lease payments  243   120 
Less: present value discount  (9)  (2)
Total operating lease liabilities $234  $118 

 

As of March 31,September 30, 2023, the total operating lease liability of $234,000$117 is classified as $208,000a current operating lease liabilities and $27,000 long term operating lease liabilities.liability.

 

The operating lease liabilities summarized above do not include variable common area maintenance (the “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 threenine months ended March 31,September 30, 2023 and 2022, approximately $22,00076,000 and $19,00069,000 of CAM was included in general and administrative operating expenses on the condensed consolidated statements of operations, respectively.

F-13

 

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 had the right to terminate this lease after three years on January 31, 2022, by giving prior notice at least three 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.2019.

 

On September 1, 2021, the Company entered into a three-year lease extension with a limited liability company controlled by Dr. Phillip Frost, a director and a principal stockholder of the Company (see Note 10 – Transactions with Related Parties).Company. On an annualized basis, straight-line rent expense is approximately $62,000, including fixed and estimable fees and taxes.

 

For the threenine months ended March 31,September 30, 2023 and 2022, operating lease expense, excluding short-term leases, finance leases and CAM charges, totaled approximately $58,000175,000 and $58,000175,000, respectively, of which $16,00047,000 for each period was to a related party.

 

F-13

Finance Leases

 

In April 2020, the Company entered into lease agreements to acquire lab equipment with 36 monthly payments of $2,000 payable through March 31, 2023. The final payment under the lease agreement was made in March 2023. The Company is in contact with the lessor to transfer title of the equipment to the Company.

 

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,September 30, 2023, total right-of-use lab equipment net of depreciation recognized under finance leases is $77,0000.00 and depreciation expense for the threenine months ended March 31,September 30, 2023 was $45,0004,000. As of December 31, 2022, total right-of-use assets lab equipment exchanged for finance lease liabilities was $194,000 and accumulated depreciation for lab equipment under finance leases was $158,000. The remaining lab equipment under the finance lease terminated on March 31, 2023, and due to the leased equipment’s remaining 25 months of useful life, it was transferred to fixed assets at book value of $32,000, and continues to depreciate.

 

Phase 2a Clinical Trial

 

On August 3, 2022 the Company engaged hVIVO, a subsidiary of London-based Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organization (CRO)(“CRO”), to conduct a Phase 2a clinical trial with the Company’s novel, broad-spectrum, orally administered antiviral influenza candidate. The Company paidprepaid a reservation fee of $1.7 million upon execution of the agreement which is scheduled to begin inand during 2023 and has been includedthe Company expensed $442,000 leaving a balance of $1,277,000 in prepaid and other expenses asat September 30, 2023. In addition, the Company incurred additional costs of March 31, 2023 and December 31, 2022. $942,000 on this agreement during the period for total expenses of approximately $1,384,000 during the nine months ended September 30, 2023.

The total estimated cost of the agreement (including the reservation fee) is approximately $7.2 million.

 

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.

 

Liberty Insurance Underwriters Inc. (“Liberty”) filed suit against us in federal court in Delaware seeking a declaratory judgment that there was no insurance coverage for any settlement, judgment, or defense costs in the class and derivative litigation, that the monies totaling approximately $1 million it paid to the Company in connection with the SEC investigation were not covered by insurance, and for recoupment of the monies already paid. We retained counsel to defend us which has filed an answer to the complaint denying its material allegations, as well as a counterclaim against Liberty for breach of contract, declaratory judgment, bad faith and violation of the Washington State Consumer Protection Act, alleging among other things that Liberty wrongfully denied the Company’s claims for coverage of the class and derivative litigations, and seeking money damages. On June 7, 2022, the court filed a Stipulation and Order for Entry of Judgment in the amount of $1,359,063.721,359,064 in favor of Liberty (the “Judgment”) following summary judgment granted by the court to Liberty on all but one of the matters at issue in the case. The Company filed an appeal in July 2022. Pending the outcome of the appeal, the Company2022 and paid $1.6 million into the registry of the court (the “Deposit”) which stayed execution of the Judgment. The United States Court of Appeals forJudgment and the Third Circuit (the “Third Circuit Court”) held oral argument on$1.6 million was expensed by the appeal on March 8, 2023. Company in 2022. On March 29, 2023, the Third Circuit ruled in favor of the Company on the appeal, thereby vacating the trial court’s prior grant of summary judgment in favor of Liberty. As a result of this ruling, the case will behas been remanded to the District Court for trial on the merits of the Company’s coverage claims for defense and settlement costs. The Company intends to file a motion withOn July 18, 2023 the District Court to seekissued an order establishing deadlines for certain pre-trial matters and setting a trial date of December 4, 2023 for the new trial. The Court had ordered the return of the $1.6 million whichmillion. On August 8, 2023, the Company paid toreceived $1.6 million as refunded by the District Court to stayregistry of the judgment. The Company is evaluating all options.court and reflected the recovery of the funds in its statement of operations for the three and nine months ended September 30, 2023.

 

F-14

10. Transactions with Related Parties

COVID-19

 

COVID-19 did not haveOn September 1, 2021, the Company entered into a material adverse effect on our operations, although we experienced delays in our supply chainthree-year lease extension with a limited liability company controlled by Dr. Phillip Frost, a director and with service partners as a resultprincipal stockholder of the COVID-19 pandemic,Company. On an annualized basis, straight-line rent expense is approximately $62,000, including recent raw materialfixed and test animal shortages affecting our researchestimable fees and development efforts. In the future, COVID-19 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 have been and may in the future be adversely impacted;
If these third parties are and/or continue to be adversely 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, which has caused and may in the future cause material delays in our research and development efforts;
We have experienced and may experience in the future shortages of laboratory materials and other resources which impact our research activities; and
As a result of the continuing impact of the virus, including potential new variants, we may fail to get access to third party laboratories which would impact our research activities.

10. Subsequent eventstaxes.

 

On April 4, 2023, the Company soldentered into a Securities Purchase Agreement with two accredited investors (the “Purchasers”) whereby the Purchasers agreed to purchase a total of 2,030,458 shares of unregistered common stock at a price of $1.97 per share for a total purchase price of $4,000,000 in two equal $2,000,000 investments. The purchasersPurchasers were an entity controlled by a director and another investor who subsequently joined the Company’s Board of Directors.

F-15F-14

 

 

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 clinical-stage antiviral compounds for unmet medical needs including Influenzainfluenza virus, Coronavirus, Noroviruscoronavirus, norovirus and Hepatitishepatitis C virus (“HCV”).

 

Impact of Inflation

 

The Company does not believe that inflation has had a material effect on its operations to date, other than the impact of inflation on the general economy. However, there is a risk that the Company’s operating costs could become subject to inflationary pressures in the future, which could have a material effect on increasing the Company’s operating costs, and which would put additional stress on the Company’s working capital resources.

 

Research and Development Update

 

During the threenine months ended March 31,September 30, 2023 the Company continued to focus its research and development efforts primarily in three areas.

 

Influenza infections

 

We have several candidates under development for the treatment of influenza infection. CC-42344, a novel oral PB2 and inhaled inhibitor, was selected as a preclinical lead for the treatment of pandemic and seasonal influenza A, and was advancedA. The oral CC-42344 has recently received regulatory authorization to initiate a Phase 1 clinical trial in 2022 as described in more detail below.2a human challenge trial. In addition, we have also initiated inhalation formulation and preclinical studies of CC-42344. 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 in vitroantiviral activity against influenza A strains, including avian pandemic strains and TamifluTamiflu® and XofluzaXofluza® resistant strains, and has favorable pharmacokinetic and drug resistance profiles.

 

In March 2022 enrollment was initiated in a randomized, double-blind, placebo-controlled Phase 1 studyclinical trial of CC-42344, which was conducted in Australia. In April 2022 we announced preliminary results from the first two cohorts of the single-ascending dose portion of the studyclinical trial in which CC-42344 demonstrated a favorable safety and pharmacokinetic profile. In December 2022 we reported favorable safety and tolerability results from a Phase 1 studyclinical trial of CC-42344 for the treatment of both pandemic and seasonal influenza A. Preparations are underway

Recently in October 2023, we announced receipt of authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) to initiate a Phase 2a human challenge clinical trial and expects to begin treating influenza-infected subjects in this trial during the fourth quarter of 2023.

Preclinical development is underway with an inhaled formulation of CC-42344 as an orala potential treatment and prophylaxis for influenza A in the United Kingdom in 2023.A.

 

In addition, novel inhibitors effective against both influenza strains A and B have been identified and are in the preclinical stage. Several of these have potenciesin vitro potency approaching single-digit nanomolar.

Merck Collaboration

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-Merck Sharp & Dohme Corp.” in the footnotes accompanying the financial statements contained in this report for more information.

3

 

In January 2021 we announced that we completed all research obligations under the Merck exclusive worldwide license and collaboration agreement, and that Merck would be solely responsible for further development of the influenza A/B antiviral compounds that were discovered using Cocrystal’s unique structure-based technologies and Nobel Prize-winning expertise. In early 2023 Merck reported that it iswas continuing development of the influenza A/B antiviral compounds under the terms of our Collaboration Agreement and iswas legally protecting the intellectual property for both companies of the compounds covered under the collaboration. In January 2023 Merck notified Cocrystal of its intent to continue development of the proprietary compounds discovered under this agreement and of their filing on behalf of both companies of multiple U.S. and international patent applications associated with these compounds. Merck continues to be responsible for managing the patents.

3

 

Coronavirus infections

 

In October 2022, we announced the selection of a novel, broad-spectrum antiviral drug candidate CDI-988 for clinical development as an oral treatment for SARS-CoV-2, the virus that causes COVID-19. CDI-988 targets a highly conserved region in the active site of SARS-CoV-2 main (3CL) protease required for viral replication and was specifically designed and developed as an oral antiviral candidate for COVID-19 using Cocrystal’s proprietary structure-based drug discovery platform technology.

In January 2022, we announced the selection of two investigational novel antiviral drug candidates, CDI-988 and CDI-873, for further development as oral treatments for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. Both compounds exhibited superior in vitropotency against SARS-CoV-2 with activity maintained against variants of concern. In preclinical studies, both candidatesconcern, and demonstrated a favorable safety profile and pharmacokinetic properties that are supportive of daily oralonce-daily dosing. We plan to beginhave initiated a randomized, double-blind, placebo-controlled Phase 1 studyclinical trial of CDI-988. In September 2023 we announced dosing of first subjects in the Phase 1 trials.

In May 2023 we announced approval from the Australian Human Research Ethics Committee (HREC) to conduct a randomized, double-blind, placebo-controlled Phase 1 trial to evaluate the safety, tolerability and pharmacokinetics of oral CDI-988 in 2023.single ascending doses (SAD) including food effect cohort, and multiple ascending doses (MAD) compared to placebo in healthy volunteers.

 

Norovirus Infections

 

We continue to identify and develop non-nucleoside polymerase and protease inhibitors using the Company’s proprietary structure-based drug design technology platform. We expect to selecthave further developed CDI-988 as a preclinical leaddual broad-spectrum antiviral inhibitor that targets a highly conserved region in the first halfactive site of 2023.coronavirus, norovirus, and other 3CL viral proteases. Preclinical studies have shown CDI-988’s pan-viral activity against different RNA viruses including potential benefit against norovirus infection. In August 2023 we announced the selection of CDI-988 as our lead norovirus infection oral candidate. Our ongoing randomized, double-blind, placebo-controlled Phase 1 clinical trial of CDI-988 in healthy subjects for coronavirus is also intended to serve our requirements of a norovirus Phase 1 clinical trial.

 

Results of Operations for the ThreeNine Months Ended March 31,September 30, 2023 compared to the ThreeNine Months Ended March 31,September 30, 2022

 

Research and Development Expense

 

Research and development expense consists primarily of compensation-related costs for our employees dedicated to research and development activities and for our Scientific Advisory Board members,clinical trials, as well as lab supplies, lab services, and facilities and equipment costs related to our research and development programs.

 

Total research and development expenses for the three months ended March 31,September 30, 2023, and 2022 were $3,907,000$4,194,000 and $2,872,000,$3,872,000, respectively. The increase of $1,035,000$322,000 was primarily due to our Influenza CC-42344 product candidate moving into a Phase 2a clinical trial and the ongoing Phase 1 clinical trial of CDI-988.

Total research and development expenses for the nine months ended September 30, 2023 and 2022 were $10,902,000 and $9,105,000, respectively. The increase of $1,797,000 was primarily due to approximately $1,384,000 to our contract research organization (“CRO”) (see Note 9 under heading Phase 2a Clinical Trial) in preparations for the CC-42344 Phase 2A2a clinical trial for pandemic and seasonal influenza A, and our oral CDI-988 Covid-19 and norovirus ongoing clinical leadtrial and Norovirus programs moving toward clinical trials, reduced by tax credits of $263,000$523,000 for research and development expenses.

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General and Administrative Expense

 

General and administrative expense includesexpenses include 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,September 30, 2023, and 2022 were $1,204,000$1,849,000 and $1,333,000,$1,822,000, respectively, remaining relatively stable between periods.

General and administrative expenses for the nine months ended September 30, 2023 and 2022 were $4,591,000 and $4,530,000, respectively. The decreaseincrease of $129,000$61,000 was primarily due to reductionprofessional fees and general corporate cost increases.

There was no impairment for nine months ended September 30, 2023. During the nine months ended September 30, 2022 the Company recorded a $19,092,000 non-cash impairment expense of stock options expenses, legal litigation and financial/listing expenses, andgoodwill.

During the decrease of D&O insurance due to market stabilized afternine months ended September 30, 2022 the spikeCompany paid $1.6 million into the registry of the insurance costcourt that was expensed as legal settlement. Following a favorable appeal ruling, the Company received a refund of the $1.6 million from the registry of the court during the pandemic.period ended September 30, 2023 (See “Note 9 - Commitments and Contingencies”) in the footnotes accompanying the financial statements contained in this report for more information on this litigation.

 

Interest Expense,Income (Expense), Net

 

Interest expenseincome (expense) for the three months ended March 31,September 30, 2023 and 2022 was $0$320,000 and $1,000, respectively. The decrease($1,000), respectively, and for the threenine months ended March 31,September 30, 2023 and 2022 was due to changes$460,000 and ($2,000), respectively. The interest income was primarily earned on cash held in the finance lease agreements.interest bearing bank accounts.

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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. The change in the fair value of derivative liabilities for the threenine months ended March 31,September 30, 2023 and 2022 was $0 and $11,000,$12,000, respectively.

 

In 2022, the Company established a wholly owned subsidiary in Australia, making it subject to foreign exchange rate fluctuations. Foreign exchange loss during the threenine months ended March 31,September 30, 2023 and 2022 was $78,000.$87,000 and $19,000, respectively.

 

Income Taxes

 

No income tax benefit or expense was recognized for the three and threenine months ended March 31,September 30, 2023 and 2022. The Company’s effective income tax rate was 0.00% for the three and nine months ended March 31,September 30, 2023 and 2022. 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 Loss

 

As a result of the above factors, net loss for the three and nine months ended March 31,September 30, 2023 was $5,452,000,$4,165,000 and $13,520,000, respectively, compared with a net loss of $4,208,000 for the three and nine months ended March 31,September 30, 2022 was $5,700,000 and $34,336,000, respectively, as a result of developments related to our expenses described above.

 

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Liquidity and Capital Resources

 

Net cash used in operating activities was $3,111,000$11,340,000 for the threenine months ended March 31,September 30, 2023 compared with net cash used in operating activities of $3,910,000$16,542,000 for the same period in 2022. This decrease was primarily due to period reductions related to completion2022 increases in prepaid expenses and other current assets for a reservation fee of our Influenza A Phase 1 clinical trial and$1.7 million (see Note 9) in preparation for our anticipated Influenza A Phase 2a clinical trial and COVID-19 Phase 1 clinical trial in 2023.a $1.6 million legal settlement (see Note 9).

 

We used $45,000$59,000 net cash for investing activities during the threenine months ended March 31,September 30, 2023 compared with no$62,000 net cash used for the same period in 2022. For the threenine months ended March 31,September 30, 2023 the level of investments increaseddecreased compared with March 31,September 30, 2022 due to reduced capital expenditure to replace laboratory equipment require to due age.expenditures in 2023 period.

 

Net cash used inprovided by financing activities totaled $7,000$3,993,000 for the threenine months ended March 31,September 30, 2023 compared with net cash provided byused in financing activities of $6,000$20,000 for the same period in 2022. This stability was primarily due to sufficient capital needs duringOn April 4, 2023, the three months ended March 31, 2023, which resultedCompany raised $4,000,000 in no equity offerings in the 2023 period compared with the three months ended March 31, 2022.a private placement sale of 2,030,458 shares of our common stock.

 

The Company has not yet established an ongoing source of revenue sufficient to cover its operating costs. The Company had $33,981,000$29,738,000 unrestricted cash on March 31,September 30, 2023. On April 4, 2023, the Company raised $4,000,000 in a private placement (see “Note 10 – Subsequent Events” in the footnotes accompanying the financial statements contained in this report). The Company believes it has sufficient cash to maintain planned operations for more than the next 12 months.

 

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.

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Historically, public and private equity offerings have been our principal source of liquidity.

 

The Company is party to the At-The-Market Offering Agreement, dated July 1, 2020 (“ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), pursuant to which the Company may issue and sell over time and from time to time, to or through Wainwright, up to $10,000,000 of shares of the Company’s common stock. During January 2021, the Company sold 1,030,000 shares of its common stock pursuant to the ATM Agreement for net proceeds of approximately $2,072,000. There were no sales under the ATM Agreement during the threenine months ended March 31,September 30, 2023.

 

On April 4, 2023, the Company entered into a Securities Purchase Agreement with two accredited investors (the “Purchasers”) wherebypursuant to which the Purchasers agreed to purchasepurchased a total of 2,030,458 shares of unregistered common stock at a price of $1.97 per share for a total purchase price of $4,000,000 in two equal $2,000,000 investments.investments in an unregistered offering exempt from registration pursuant to Section 4(a)(2) of the Securities Act of 1933 and Rule 506(b) promulgated thereunder.

 

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 stockholders.

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Cautionary Note Regarding Forward-Looking Statements

 

This report includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the future effectiveness of our product candidates, our plans for the future development of preclinical and clinical drug candidates, the expected time of achieving certain value driving milestones in our programs, including reporting the results of the Phase 1 studyclinical trial and commencing the Phase 2a clinical studyclinical trial for our Influenza A program, and progressing our COVID-19 and Norovirusnorovirus programs towardsin the clinical development process, our expectations regarding future operating results and 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.

 

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 and uncertainties arising from the risks arising from inflation, interest rate increases, the recent banking crisis, the possibility of a recession and the economic impact of the wars in Israel and Ukraine war on our Company, our collaboration partners, and on the U.S., U.K., Australia and global economies, including downturns in economic activity and capital markets, manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors and our current and any future CROs and contract manufacturing organizations (CMOs), the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, our reliance on Merck for further development in the influenza A/B program under the license and collaboration agreement, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government,governmental authorities, potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop, and the outcome of the ongoing litigation with Liberty. 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, 2022. We undertake no obligation to publicly update or revise any forward-looking statements, whether as the result of new information, future events or otherwise.

6

 

Critical Accounting Policies and Estimates

 

In our Annual Report on Form 10-K for the year ended December 31, 2022, 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.

 

Readers are encouraged to review these disclosures in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 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 ChiefCo-Chief Executive OfficerOfficers 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 ChiefCo-Chief Executive OfficerOfficers and Chief Financial Officer have concluded that our disclosure controls and procedures as of March 31,September 30, 2023 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,September 30, 2023. 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.

 

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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, 2022.2022 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023.

 

As previously disclosed, with respectLiberty Insurance Underwriters Inc. (“Liberty”) filed suit against us in federal court in Delaware seeking a declaratory judgment that there was no insurance coverage for any settlement, judgment, or defense costs in the class and derivative litigation, that the monies totaling approximately $1 million it paid to the Company in connection with the SEC investigation were not covered by insurance, and for recoupment of the monies already paid. We retained counsel to defend us which has filed an answer to the complaint denying its material allegations, as well as a counterclaim against Liberty litigation,for breach of contract, declaratory judgment, bad faith and violation of the Washington State Consumer Protection Act, alleging among other things that Liberty wrongfully denied the Company’s claims for coverage of the class and derivative litigations, and seeking money damages. On June 7, 2022, the court filed a Stipulation and Order for Entry of Judgment in the amount of $1,359,064 in favor of Liberty (the “Judgment”) following summary judgment granted by the court to Liberty on all but one of the matters at issue in the case. The Company filed an appeal in July 2022 and paid $1.6 million into the registry of the court (the “Deposit”) which stayed execution of the Judgment and the $1.6 million was expensed by the Company in 2022. On March 29, 2023, the United States Court of Appeals for the Third Circuit ruled in favor of the Company on the appeal, after hearing oral arguments on March 8, 2023, thereby vacating the trial court’s prior grant of summary judgment in favor of Liberty. As a result of this ruling, the case will behas been remanded to the District Court for trial on the merits of the Company’s coverage claims for defense and settlement costs. The Company intends to file a motion withOn July 18, 2023 the District Court to seekissued an order establishing deadlines for certain pre-trial matters and setting a trial date of December 4, 2023 for the new trial. The Court had ordered the return of the $1.6 million whichmillion. On August 8, 2023, the Company paid toreceived $1.6 million as refunded by the District Court to stayregistry of the judgment. See “Note 9. Commitmentscourt and Contingencies-Contingencies”reflected the recovery of the funds in its statement of operations for the footnotes accompanying the financial statements contained in this report for more information.three and nine months ended September 30, 2023.

 

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.

 

8

 

 

ITEM 6. EXHIBITS

 

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

 

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  8/16/21  3.1    
3.1(a) Certificate of Amendment to Certificate of Incorporation 8-K 10/3/22 3.1  
3.2  Amended and Restated Bylaws  8-K  2/19/21  3.1    
10.1 Securities Purchase Agreement dated April 1, 2023 8-K 4/10/2023 10.1  
10.2 

Consulting and Scientific Advisory Board Agreement, dated April 13, 2021 with Roger Kornberg

 

10-Q

 8/16/21 

10.1

  
31.1  Certification of Principal Executive Officer (302)              Filed
31.2  Certification of Principal Executive Officer (302)              Filed
31.3  Certification of Principal Financial Officer (302)              Filed
32.1  Certification of Principal Executive and Principal Financial Officer (906)              Furnished*
101.INS  Inline XBRL Instance Document              Filed
101.SCH  Inline XBRL Taxonomy Extension Schema Document              Filed
101.CAL  Inline XBRL Taxonomy Extension Calculation Linkbase Document              Filed
101.DEF  Inline XBRL Taxonomy Extension Definition Linkbase Document              Filed
101.LAB  Inline XBRL Taxonomy Extension Label Linkbase Document              Filed
101.PRE  Inline XBRL Taxonomy Extension Presentation Linkbase Document              Filed
104  Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)              Filed
Exhibit   Incorporated by Reference 

Filed or

Furnished

No. Exhibit Description Form Date Number Herewith
3.1 Certificate of Incorporation, as amended 10-Q 8/16/21 3.1  
3.1(a) Certificate of Amendment to Certificate of Incorporation 8-K 10/3/22 3.1  
3.2 Amended and Restated Bylaws 8-K 2/19/21 3.1  
31.1 Certification of Principal Executive Officer (302)       Filed
31.2 Certification of Principal Executive Officer (302)       Filed
31.3 Certification of Principal Financial Officer (302)       Filed
32.1 Certification of Principal Executive and Principal Financial Officer (906)       Furnished*
101.INS Inline XBRL Instance Document       Filed
101.SCH Inline XBRL Taxonomy Extension Schema Document       Filed
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document       Filed
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document       Filed
101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document       Filed
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document       Filed
104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)       Filed

 

* 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.

** Certain schedules and other attachments have been omitted. The Company undertakes to furnish the omitted schedules and attachments to the Securities and Exchange Commission upon request.

 

Copies of this report (including the financial statements) and any of the exhibits referred to above will be furnished at no cost to our stockholders 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 15,November 13, 2023By:/s/ Sam Lee
  Sam Lee
  President and Co-Chief Executive Officer
  (Principal Executive Officer)

Dated: May 15,November 13, 2023By:/s/ James Martin
  James Martin
  

Chief Financial Officer and Co-Chief

Executive Officer

  (Principal Executive Officer and Principal Financial Officer)

 

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