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 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 filer
☐
Accelerated
filer
☐
Non-accelerated
filer
☒
Smaller
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 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 SEPTEMBER 30, 2023
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 Information
8
Item 6. Exhibits
9
SIGNATURES
10
2
Part
I – FINANCIAL INFORMATION
COCRYSTAL
PHARMA, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands, except per share data)
September 30, 2023
December 31, 2022
(unaudited)
Assets
Current assets:
Cash
$ 29,738
$ 37,144
Restricted cash
75
75
Tax credit receivable
550
716
Prepaid expenses and other current assets
1,842
2,243
Total current assets
32,205
40,178
Property and equipment, net
252
342
Deposits
46
46
Operating lease right-of-use assets, net (including $ 57 and $ 99 respectively, to related party)
111
274
Total assets
$ 32,614
$ 40,840
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses
$ 1,806
$ 976
Current maturities of finance lease liabilities
-
7
Current maturities of operating lease liabilities (including $ 57 and $ 59 respectively, to related party)
118
233
Total current liabilities
1,924
1,216
Long-term liabilities:
Operating lease liabilities (including $ 0 and $ 42 respectively, to related party)
-
57
Total liabilities
1,924
1,273
Commitments and contingencies (Note 9)
-
-
Stockholders’ equity:
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
342,130
337,489
Accumulated deficit
( 311,450 )
( 297,930 )
Total stockholders’ equity
30,690
39,567
Total liabilities and stockholders’ equity
$ 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
Three months ended September 30,
Nine months ended September 30,
2023
2022
2023
2022
Operating expenses:
Research and development
4,194
3,872
10,902
9,105
General and administrative
1,849
1,822
4,591
4,530
Legal settlement
( 1,600 )
-
( 1,600 )
1,600
Impairments
-
-
-
19,092
Total operating expenses
4,443
5,694
13,893
34,327
Loss from operations
( 4,443 )
( 5,694 )
( 13,893 )
( 34,327 )
Other income (expense):
Interest income (expense), net
320
( 1 )
460
( 2 )
Foreign exchange loss
( 42 )
( 5 )
( 87 )
( 19 )
Change in fair value of derivative liabilities
-
-
-
12
Total other expense, net
278
( 6 )
373
( 9 )
Net loss
$ ( 4,165 )
$ ( 5,700 )
( 13,520 )
( 34,336 )
Net loss per common share, basic and diluted
$ ( .41 )
$ ( 0.70 )
( 1.43 )
( 4.23 )
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
Common Stock
Additional
Paid-in
Accumulated
Total
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance as of December 31, 2022
8,143
$ 8
$ 337,489
$ ( 297,930 )
$ 39,567
Stock-based compensation
-
-
291
-
291
Net loss
-
-
-
( 5,189 )
( 5,189 )
Balance as of March 31, 2023
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’
Shares
Amount
Capital
Deficit
Equity
Balance as of December 31, 2021
8,143
$ 8
$ 336,544
$ ( 259,093 )
$ 77,549
Stock-based compensation
-
-
239
-
239
Net loss
-
-
-
( 4,208 )
( 4,208 )
Balance as of March 31, 2022
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
Nine months ended September 30,
2023
2022
Operating activities:
Net loss
$ ( 13,520 )
$ ( 34,336 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense
149
137
Amortization of right of use assets
163
151
Loss on impairment of goodwill
-
19,092
Stock-based compensation
643
696
Payments on operating lease liabilities
( 172 )
( 154 )
Change in fair value of derivative liabilities
-
( 12 )
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
401
( 2,197 )
Tax credit receivable
166
-
Accounts payable and accrued expenses
830
81
Net cash used in operating activities
( 11,340 )
( 16,542 )
Investing activities:
Purchases of property and equipment
( 59 )
( 62 )
Net cash used in investing activities
( 59 )
( 62 )
Financing activities:
Payments on finance lease liabilities
( 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
3,993
( 20 )
Net decrease in cash and restricted cash
( 7,406 )
( 16,624 )
Cash and restricted cash at beginning of period
37,219
58,705
Cash and restricted cash at end of period
$ 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. 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 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,
the 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”).
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 warrant 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 three U.S. financial institutions, which may, at times, exceed federally insured limits of $ 250,000 for each institution
where accounts are held. At September 30, 2023 and December 31, 2022, our two operating accounts held approximately $ 29,738,000 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
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 $ 550,000 for the nine months ended September 30, 2023; and collected approximately $ 716,000 of tax credit receivable
previously recorded, resulting in a tax credit receivable of $ 550,000 at 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 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 nine months ended 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
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 September 30, 2023, and December 31, 2022, property and equipment consists of (table in thousands):
Schedule
of Property and Equipment
September 30, 2023
December 31, 2022
Lab equipment
$ 1,708
$ 1,631
Finance lease right-of-use lab equipment
162
194
Computer and office equipment
145
131
Total property and equipment
2,015
1,956
Less: accumulated depreciation and amortization
( 1,763 )
( 1,614 )
Property and equipment, net
$ 252
$ 342
Total
depreciation and amortization expense were approximately $ 149,000 and $ 137,000 for the nine months ended September 30, 2023 and 2022,
which includes amortization expense of $ 7,164 and $ 20,000 for the nine months ended 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
September 30, 2023
December 31, 2022
Accounts payable
$ 568
$ 614
Accrued compensation
173
130
Accrued other expenses
1,065
232
Total accounts payable and accrued expenses
$ 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.
5.
Common Stock
The
Company has 150,000,000 shares of common stock, $ 0.001 par value per share, authorized as of September 30, 2023, and December 31, 2022.
The Company had 10,174,000 and 8,143,000 shares issued and outstanding as of 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 2015 (the “2015 Plan”) under which 833,333 shares of common stock have been reserved
for issuance to employees, and non-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 September 30, 2023, 274,599 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, June, September and
December, with the first such quarterly installment vesting on September 30, 2024 .
The
following table summarizes stock option transactions for the 2015 Plan, collectively, for the nine months ended 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
Balance at December 31, 2022
484
350
$ 14.98
$ 0.00
Increase in authorized options
-
-
-
-
Exercised
-
-
-
-
Granted
( 209 )
209
2.67
-
Expired
-
-
-
-
Cancelled
-
-
-
-
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. For the three and nine months ended September 30, 2023 and 2022, equity-based compensation
expense recorded was $ 173,000 and $ 643,000 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, Assumption
2023
2022
Nine Months Ended September 30,
2023
2022
Risk-Free interest rate
2.33 %
1.64 %
Expected dividend yield
0.00 %
0.00 %
Expected volatility
95.08 %
87.81 %
Expected term (in years)
5.10
4.8
As
of September 30, 2023, there was approximately $ 879,000 of total unrecognized compensation expense related to non-vested stock options
that is expected to be recognized over a weighted average period of 1.1 years. For options granted and outstanding, there were 559,000
options outstanding which were fully vested or expected to vest, with an aggregate intrinsic value of $ 0.00 , a weighted average exercise
price of $ 10.37 and weighted average remaining contractual term of 8.47 years at September 30, 2023. For vested and exercisable options,
outstanding shares totaled 264,000 , with an aggregate intrinsic value of $ 0.00 . These options had a weighted average exercise price of
$ 17.68 per share and a weighted-average remaining contractual term of 7.37 years at September 30, 2023.
The
aggregate intrinsic value of outstanding and exercisable options at September 30, 2023 was calculated based on the closing price of the
Company’s common stock as reported on The Nasdaq Capital Market on September 30, 2023 of $ 1.87 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
September 30, 2023
September 30, 2022
Stock options issued and outstanding
558
350
Shares authorized for future option grants
275
484
Warrants outstanding
13
20
Total
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 nine months
ended September 30, 2023 (in thousands):
Summary of Warrant Activity
Warrants
Accounted for as: Equity
Warrants
Accounted for as:
Liabilities
May 2018
Warrants
October 2013
Warrants
January 2014
Warrants
Total
Outstanding, December 31, 2022
-
2
11
13
Exercised
-
-
-
-
Granted
-
-
-
-
Expired
-
-
-
-
Outstanding, September 30, 2023
-
2
11
13
Expiration date:
-
10/24/2023
01/16/2024
-
Warrants
Classified as Liabilities
Liability-classified
warrants consist of warrants issued by Biozone Pharmaceuticals, Inc. (“Biozone”), the Company’s predecessor, in connection
with an equity financing 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 September 30, 2023:
Schedule of Fair Value of Warrants Classified as Liabilities
October 2013
Warrants
January 2014
Warrants
Strike price
$ 180.00
$ 180.00
Expected dividend yield
0.00 %
0.00 %
Contractual term (years)
0.1
0.3
Cumulative volatility
133.64 %
134.93 %
Risk-free rate
4.93 %
4.89 %
Value per warrants
$ 0.00
$ 0.00
Fair value (in thousands)
$ 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
Strike price
$ 180.00
$ 180.00
Expected dividend yield
0.00 %
0.00 %
Expected term (years)
0.8
1.0
Cumulative volatility
143.06 %
145.00 %
Risk-free rate
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 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.
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 6.8 % and
the weighted average remaining lease term is 0.6 years.
The
following table summarizes the Company’s maturities of operating lease liabilities, by year and in aggregate, as of September 30,
2023 (table in thousands):
Schedule
of Maturities of Operating Lease Liabilities
2023 (excluding the nine months ended September 30, 2023)
$ 62
2024
58
2025
-
Thereafter
-
Total operating lease payments
120
Less: present value discount
( 2 )
Total operating lease liabilities
$ 118
As
of September 30, 2023, the total operating lease liability of $117 is classified as a current operating lease 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 nine months ended September 30, 2023 and 2022, approximately $ 76,000 and $ 69,000 of 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 .
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. On an annualized basis, straight-line rent expense is approximately $ 62,000 , including
fixed and estimable fees and taxes.
For
the nine months ended September 30, 2023 and 2022, operating lease expense, excluding short-term leases, finance leases and CAM charges,
totaled approximately $ 175,000 and $ 175,000 , respectively, of which $ 47,000 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 September 30, 2023, total right-of-use lab equipment net of depreciation recognized under
finance leases is $ 0.00 and depreciation expense for the nine months ended September 30, 2023 was $ 4,000 . 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”), to conduct a Phase 2a clinical trial with the Company’s novel,
broad-spectrum, orally administered antiviral influenza candidate. The Company prepaid a reservation fee of $ 1.7
million upon execution of the agreement and during 2023 the Company expensed $ 442,000 leaving a balance of $ 1,277,000 in prepaid and
other expenses at September 30, 2023. In addition, the Company incurred additional costs of $ 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 $ 1,359,064 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 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 has been remanded to the District Court for
trial on the merits of the Company’s coverage claims for defense and settlement costs. On July 18, 2023 the District Court issued
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. On August 8, 2023, the Company received $ 1.6 million as refunded by the registry of the court
and reflected the recovery of the funds in its statement of operations for the three and nine months ended September 30, 2023.
10.
Transactions with Related Parties
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. On an annualized basis, straight-line rent expense is approximately $ 62,000 , including
fixed and estimable fees and taxes.
On
April 4, 2023, the Company entered 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 Purchasers were an entity controlled by a director and
another investor who subsequently joined the Company’s Board of Directors.
F- 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 influenza virus, coronavirus, norovirus and hepatitis 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 nine months ended 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. The oral CC-42344 has recently received regulatory
authorization to initiate a Phase 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 vitro antiviral activity against influenza A strains, including avian
pandemic strains and Tamiflu® and Xofluza® 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 clinical 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 clinical
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 clinical trial of CC-42344 for the treatment of both pandemic and seasonal influenza A.
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 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 a potential treatment and prophylaxis for influenza 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 in 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 was continuing
development of the influenza A/B antiviral compounds under the terms of our Collaboration Agreement and was 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.
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. CDI-988 exhibited superior in vitro potency
against SARS-CoV-2 with activity maintained against variants of concern, and demonstrated a safety profile and pharmacokinetic properties
that are supportive of once-daily dosing. We have initiated a randomized, double-blind, placebo-controlled Phase 1 clinical 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 single ascending doses (SAD) including food
effect cohort, and multiple ascending doses (MAD) compared to placebo in healthy volunteers.
Norovirus
Infections
We
have further developed CDI-988 as a dual broad-spectrum antiviral inhibitor that targets a highly conserved region in the active site
of 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 Nine Months Ended September 30, 2023 compared to the Nine Months Ended 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 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 September 30, 2023, and 2022 were $4,194,000 and $3,872,000,
respectively. The increase of $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 2a clinical trial for pandemic and seasonal influenza A, and our
oral CDI-988 Covid-19 and norovirus ongoing clinical trial and reduced by tax credits of $523,000 for research and development
expenses.
4
General
and Administrative Expense
General
and administrative expenses 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 September 30, 2023, and 2022 were $1,849,000 and $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 increase
of $61,000 was primarily due to professional 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 goodwill.
During
the nine months ended September 30, 2022 the Company paid $1.6 million into the registry of the court 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 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
Income (Expense), Net
Interest
income (expense) for the three months ended September 30, 2023 and 2022 was $320,000 and ($1,000), respectively, and for the nine months
ended September 30, 2023 and 2022 was $460,000 and ($2,000), respectively. The interest income was primarily earned on
cash held in interest bearing bank accounts.
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 nine months ended September 30, 2023 and 2022 was $0 and $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 nine months ended September 30, 2023 and 2022 was $87,000 and $19,000, respectively.
Income
Taxes
No
income tax benefit or expense was recognized for the three and nine months ended September 30, 2023 and 2022. The Company’s effective
income tax rate was 0.00% for the three and nine months ended 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 September 30, 2023 was $4,165,000 and $13,520,000, respectively,
compared with a net loss for the three and nine months ended September 30, 2022 was $5,700,000 and $34,336,000, respectively, as a result
of developments related to our expenses described above.
5
Liquidity
and Capital Resources
Net
cash used in operating activities was $11,340,000 for the nine months ended September 30, 2023 compared with net cash used in
operating activities of $16,542,000 for the same period in 2022. This decrease was primarily due to 2022 increases in prepaid expenses and other current assets for a reservation
fee of $1.7 million (see Note 9) in preparation for our Influenza A Phase 2a clinical trial and a $1.6 million legal settlement (see Note 9).
We
used $59,000 net cash for investing activities during the nine months ended September 30, 2023 compared with $62,000 net cash used for
the same period in 2022. For the nine months ended September 30, 2023 the level of investments decreased compared with September 30,
2022 due to reduced capital expenditures in 2023 period.
Net
cash provided by financing activities totaled $3,993,000 for the nine months ended September 30, 2023 compared with net cash used in
financing activities of $20,000 for the same period in 2022. On April 4, 2023, the Company raised $4,000,000 in 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 $29,738,000 unrestricted
cash on September 30, 2023. 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. 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 nine months ended September 30, 2023.
On
April 4, 2023, the Company entered into a Securities Purchase Agreement with two accredited investors (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.
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.
6
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 clinical
trial and commencing the Phase 2a clinical clinical trial for our Influenza A program, and progressing our COVID-19 and norovirus programs
in 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 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 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.
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 Co-Chief Executive Officers
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 Co-Chief Executive Officers and Chief Financial Officer have concluded that our disclosure controls and procedures
as of 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 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.
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, 2022 and our Quarterly Report on Form 10-Q for the quarter ended June
30, 2023.
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 $1,359,064 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 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 has been remanded to the District Court for
trial on the merits of the Company’s coverage claims for defense and settlement costs. On July 18, 2023 the District Court issued
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. On August 8, 2023, the Company received $1.6 million as refunded by the registry of the court
and reflected the recovery of the funds in its statement of operations for the 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
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:
November 13, 2023
By:
/s/
Sam Lee
Sam
Lee
President
and Co-Chief Executive Officer
(Principal
Executive Officer)
Dated:
November 13, 2023
By:
/s/
James Martin
James
Martin
Chief
Financial Officer and Co-Chief
Executive
Officer
(Principal
Executive Officer and Principal Financial Officer)
10
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.