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, 2025
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 May 15, 2025, 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, 2025
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
9
Item 4. Controls and Procedures
9
Part II - OTHER INFORMATION
Item 1. Legal Proceedings
10
Item 1. A. Risk Factors
10
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
10
Item 3. Defaults Upon Senior Securities
10
Item 4. Mine Safety Disclosures
10
Item 5. Other Information
10
Item 6. Exhibits
10
SIGNATURES
11
2
Part I – FINANCIAL INFORMATION
COCRYSTAL PHARMA, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except per share data)
March 31, 2025
December 31, 2024
(unaudited)
Assets
Current assets:
Cash
$ 6,921
$ 9,860
Restricted cash
75
75
Tax credit receivable
1,445
1,215
Prepaid expenses and other current assets
385
430
Total current assets
8,826
11,580
Property and equipment, net
127
153
Deposits
86
29
Operating lease right-of-use assets, net (including $ 140 and $ 152 to related party)
1,620
1,694
Total assets
$ 10,659
$ 13,456
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses
$ 1,622
$ 2,127
Current maturities of operating lease liabilities (including $ 51 and $ 49 to related party)
309
301
Total current liabilities
1,931
2,428
Long-term liabilities:
Operating lease liabilities (including $ 90 and $ 104 to related party)
1,424
1,505
Total long-term liabilities
1,424
1,505
Total liabilities
3,355
3,933
Commitments and contingencies
-
-
Stockholders’ equity:
Common stock, $ 0.001 a par value: 100,000 shares authorized as of March 31, 2025 and December 31, 2024; 10,174 shares issued and outstanding as of March 31, 2025 and December 31, 2024
10
10
Additional paid-in capital
343,013
342,931
Accumulated deficit
( 335,719 )
( 333,418 )
Total stockholders’ equity
7,304
9,523
Total liabilities and stockholders’ equity
$ 10,659
$ 13,456
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)
2025
2024
Three months ended March 31,
2025
2024
Operating expenses:
Research and development
1,360
2,950
General and administrative
981
1,208
Total operating expenses
2,341
4,158
Loss from operations
( 2,341 )
( 4,158 )
Other income (expense):
Interest income (expense), net
37
220
Foreign exchange gain (loss), net
3
( 18 )
Total other income (expense), net
40
202
Net loss
$ ( 2,301 )
$ ( 3,956 )
Net loss per common share, basic and diluted
$ ( 0.23 )
$ ( 0.39 )
Weighted average number of common shares, basic and diluted
10,174
10,174
See accompanying notes to condensed consolidated financial
statements.
F- 2
COCRYSTAL PHARMA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY
For the three months ended March 31, 2025 and 2024
(unaudited)
(in thousands)
Common Stock
Additional
Paid-in
Accumulated
Total
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance as of December 31, 2024
10,174
$ 10
$ 342,931
$ ( 333,418 )
$ 9,523
Stock-based compensation
-
-
82
82
Net loss
-
-
-
( 2,301 )
( 2,301 )
Balance as of March 31, 2025
10,174
$ 10
$ 343,013
$ ( 335,719 )
$ 7,304
Common Stock
Additional
Paid-in
Accumulated
Total
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance as of December 31, 2023
10,174
$ 10
$ 342,288
$ ( 315,914 )
$ 26,384
Balance
10,174
$ 10
$ 342,288
$ ( 315,914 )
$ 26,384
Stock-based compensation
-
-
157
-
157
Net loss
-
-
-
( 3,956 )
( 3,956 )
Balance as of March 31, 2024
10,174
$ 10
$ 342,445
$ ( 319,870 )
$ 22,585
Balance
10,174
$ 10
$ 342,445
$ ( 319,870 )
$ 22,585
See accompanying notes to condensed consolidated financial
statements.
F- 3
COCRYSTAL PHARMA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
2025
2024
Three months ended March 31,
2025
2024
Operating activities:
Net loss
$ ( 2,301 )
$ ( 3,956 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense
25
35
Stock-based compensation
82
157
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
45
201
Tax credit receivable
( 229 )
( 113 )
Deposits
( 57 )
-
Decrease right of use assets
74
87
Accounts payable and accrued expenses
( 505 )
( 883 )
Decrease operating lease liabilities
( 73 )
( 31 )
Net cash used in operating activities
( 2,939 )
( 4,503 )
Investing activities:
Purchases of property and equipment
-
( 8 )
Net cash used in investing activities
-
( 8 )
Net decrease in cash and restricted cash
( 2,939 )
( 4,511 )
Cash and restricted cash at beginning of period
9,935
26,428
Cash and restricted cash at end of period
$ 6,996
$ 21,917
See accompanying notes to condensed consolidated financial
statements.
F- 4
COCRYSTAL PHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED MARCH 31, 2025 AND 2024
(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.
Liquidity and going concern
The Company’s consolidated financial
statements are prepared using generally accepted accounting principles in the United States of America applicable to a going
concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The
Company has incurred net losses and negative operating cash flows since inception. For the three months ended March 31, 2025, the
Company recorded a net loss of approximately $ 2,301,000 and
used approximately $ 2,939,000 of
cash in operating activities. These factors raise substantial doubt about the Company’s ability to continue as a going concern. In addition,
the Company’s independent registered public accounting firm, in its report on the Company’s December 31, 2024 financial statements,
has expressed substantial doubt about the Company’s ability to continue as a going concern. The ability of the Company to continue
as a going concern is dependent upon the Company’s ability to raise additional funds and implement its strategies. The financial
statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.
On March 31, 2025, the Company had cash and restricted
cash of approximately $ 6,996,000 . Restricted cash represents amounts pledged as collateral for financing arrangements that are currently
limited to the issuance of business credit cards. The restriction will end upon the conclusion of these financing arrangements. We believe
that our current resources will not be sufficient to fund our operations beyond the next 12 months. This estimate is based, in part, upon
our currently projected expenditures.
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,
2025, the Company has primarily funded its operations through equity offerings.
The Company will need to continue obtaining adequate
capital to fund operating losses until it becomes profitable. The Company can give no assurances that the additional capital it is able
to raise, if any, will be sufficient to meet its needs, or that any such financing will be obtainable on acceptable terms. Our future
cash requirements, and the timing of those requirements, will depend on a number of factors, including economic conditions, the approval
and success of our products in development, the continued progress of research and development of our product candidates, the timing and
outcome of clinical trials and regulatory approvals, the costs involved in preparing, filing, prosecuting, maintaining, defending, and
enforcing patent claims and other intellectual property rights, the status of competitive products, the availability of financing, our
success in developing markets for our product candidates and legal proceedings that may arise. We have historically not generated sustained
positive cash flow and if we are not able to secure additional funding when needed, we may have to delay, reduce the scope of, or eliminate
one or more of our clinical trials or research and development programs. If the Company is unable to obtain adequate capital, it could
be forced to cease operations or substantially curtail its drug development activities. The Company expects to continue incurring substantial
operating losses and negative cash flows from operations over the next several years during its pre-clinical and clinical development
phases.
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, 2024 filed on March 31, 2025 (“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. (“Cocrystal
Australia”), RFS Pharma, LLC and Cocrystal Merger Sub, Inc. Intercompany transactions and balances have been eliminated. Cocrystal
Discovery, Inc. conducts all of the Company’s research and development activities and oversees ongoing clinical trials conducted
by others. Cocrystal Australia operates clinical trials in Australia. The other two subsidiaries are inactive.
Segments
The Company’s Co-Chief Executive Officer and
President (“CEO”) is our chief operating decision maker (“CODM”) and evaluates performance and makes operating
decisions about allocating resources based on financial data presented on a consolidated basis. Because our CODM evaluates financial performance
on a consolidated basis, the Company has determined that it operates as a single reportable segment composed of the consolidated financial
results of Cocrystal Pharma, Inc. The measure of segment assets is reported on the consolidated balance sheets as total assets (see Note
9).
F- 5
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 most significant estimates in the Company’s consolidated financial statements relate to clinical trial
costs and accruals and the fair value of stock-based compensation. The Company bases estimates and assumptions on historical experience,
when available, and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates
and assumptions on an ongoing basis, and its actual results may differ from estimates made under different assumptions or conditions.
Concentrations of Credit Risk
Financial instruments that potentially subject the
Company to significant concentrations of credit risk consist primarily of cash deposited in accounts held at two U.S. financial institutions,
which may, at times, exceed federally insured limits of $ 250,000
for each institution where accounts are held. At March 31, 2025 and December 31, 2024, our primary operating accounts held approximately
$ 6,921,000 and $ 9,860,000 ,
respectively, and our collateral account balance was $ 75,000 during both periods and held at a different institution. The Company has not experienced any losses in such accounts and
believes it is not exposed to significant risks thereof.
Risks and uncertainties
The Company’s future results of operations involve a number of risks
and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially
from expectations include, but are not limited to, rapid technological change, ability to obtain regulatory approvals, competition from
currently available treatments and therapies, competition from larger companies, effective protection of proprietary technology, maintenance
of strategic relationships, and dependence on key individuals.
Products developed by the Company will require clearances from the U.S.
Food and Drug Administration (the “FDA”) and other international regulatory agencies prior to commercial sales in their respective
markets. The Company’s products may not receive the necessary clearances and if they are denied clearance, clearance is delayed,
or the Company is unable to maintain clearance, the Company’s business could be materially, adversely impacted.
See Item 1A- Risk Factors in our Annual Report on
Form 10-K for the year ended December 31, 2024 for more information on the risks and uncertainties we face.
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.
F- 6
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.
At March 31, 2025 and December 31, 2024, the carrying amounts of financial
assets and liabilities, such as cash, tax 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.
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 (“Refundable
Tax Credits”) from the federal and provincial taxation authorities, based on qualifying expenditures incurred during the fiscal
year. The Refundable Tax 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. As of December 31,
2024, balance of Refundable Tax Credits was approximately $ 1,123,843 . The Company estimated and accrued Refundable Tax Credits for the
three months ended March 31, 2025 of approximately $ 278,303 , resulting in a total balance of Refundable Tax Credits receivable of approximately
$ 1,402,146 as of the period then ended.
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, 2025, the Company assessed its income
tax expense based on its projected future taxable income for the year ending December 31, 2025 and therefore recorded no amount for income
tax expense for the three months ended March 31, 2025. 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, 2024 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. Recognition of compensation expense for non-employees is in the same period and manner as if the Company had paid
cash for the services.
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.
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 restricted stock units.
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 Anti-dilutive Securities Excluded from Calculations of Net Loss Per Share
2025
2024
March 31,
2025
2024
Outstanding options to purchase common stock
549
558
Unvested restricted stock units
155
-
Total
704
558
Recent Accounting Pronouncements
In November 2024, the Financial Accounting Standards Board (FASB) issued
ASU No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation
of Income Statement Expenses which includes amendments that require disclosure in the notes to financial statements of specified information
about certain costs and expenses, including purchases of inventory; employee compensation; and depreciation, amortization and depletion
expenses for each caption on the income statement where such expenses are included. The amendments are effective for the Company’s
annual periods beginning January 1, 2027, with early adoption permitted, and should be applied either prospectively or retrospectively.
The Company is in the process of evaluating this ASU to determine its impact on the Company’s disclosures.
Other 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.
F- 8
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, 2025, and
December 31, 2024, property and equipment consists of (table in thousands):
Schedule of Property and Equipment
March 31, 2025
December 31, 2024
Lab equipment (excluding equipment under finance leases)
$ 1,765
$ 1,765
Finance lease right-of-use lab equipment obtained in exchange for finance lease liabilities, net
162
162
Computer and office equipment
155
155
Total property and equipment
2,082
2,082
Less: accumulated depreciation and amortization
( 1,955 )
( 1,929 )
Property and equipment, net
$ 127
$ 153
Total depreciation and amortization expense were
approximately $ 25,000
and $ 35,000
for the three months ended March 31, 2025 and 2024, For additional finance leases information, refer to Note 7 – 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, 2025
December 31, 2024
Accounts payable
$ 808
$ 1,542
Accrued compensation
100
117
Accrued other expenses
714
468
Total accounts payable and accrued expenses
$ 1,622
$ 2,127
Accounts payable and accrued 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
On June 27, 2024, the Company, following approval
of the Company’s stockholders at the 2024 Annual Meeting of Stockholders filed an amendment to its Certificate of Incorporation
with the Secretary of State of the State of Delaware (the “Amendment”) to decrease the number of shares of authorized capital
stock of the Company from 155,000,000 shares of capital stock, consisting of 150,000,000 shares of common stock and 5,000,000 shares of
preferred stock, to 101,000,000 shares of capital stock consisting of 100,000,000 shares of common stock and 1,000,000 shares of preferred
stock. The Amendment became effective on June 27, 2024.
As of March 31, 2025, the Company has authorized 100,000,000
shares of common stock, $ 0.001 par value per share. The Company had 10,174,000 and 10,174,000 shares issued and outstanding as of March
31, 2025, and December 31, 2024.
The holders of common stock are entitled to one vote
for each share of common stock held.
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 March 31, 2025, 37,000 shares remain available for future grants under the 2015 Plan. The 2015 Plan expires on June 29,
2025.
F- 9
On April 2, 2025, our board of directors
approved an Equity Incentive Plan (the “2025 Plan”) that remains subject to shareholder approval and ratification. The
2025 Plan provides for the grant of incentive stock options, qualified stock options, restricted stock awards, restricted stock
units, stock appreciation rights, and performance shares or units and cash awards. Awards may be granted under the 2025 Plan to our
employees, directors and independent contractors. the aggregate number of shares of Common Stock which shall be available
for grants or payments of Awards under the 2025 Plan during its term shall initially be 1,500,000 (the “Total Plan Shares”).
The Total Plan Shares will automatically increase on January 1st of each year, for a period of nine years commencing on January
1, 2026, in an amount equal to 5 %
of the total number of shares of Common Stock outstanding as of December 31 of the preceding calendar year on a fully diluted
basis.
The 2025 Plan also provides that, notwithstanding the annual increase provision, in no event will the increase in
Total Plan Shares available under the 2025 Plan pursuant to the increase provision exceed 2,500,000 additional shares (or a total of up
to 4,000,000 Total Plan Shares), subject to adjustment as provided under the 2025 Plan. The 2025 Plan is effective as of March 31, 2025;
however, the 2025 Plan is subject to approval of our stockholders which the Company is seeking at its annual meeting of stockholders scheduled
for June 25, 2025.
Common Stock Reserved for Future Issuance
The following table presents information concerning common stock available
for future issuance (in thousands) as of March 31, 2025:
Schedule of Common Stock Available
for Future Issuance
Shares Available for Grant
Balance at December 31, 2024
27
Cancelled or forfeited
10
Balance at March 31, 2025
$ 37
Stock Options
The following table summarizes stock option transactions for the 2015 Plan,
collectively, for the three months ended March 31, 2025 (in thousands, except per share amounts):
Schedule of Stock Option Transactions
Total
Options
Outstanding
Weighted
Average
Exercise
Price
Aggregate
Intrinsic
Value
Balance at December 31, 2024
550
$ 10.37
$ -
Exercised
-
-
-
Granted
-
-
-
Cancelled
( 1 )
-
-
Balance at March 31, 2025
549
$ 10.39
$ -
Restricted Stock Units
On August 12, 2024, the Company’s Compensation
Committee approved the issuance of 256,000 restricted stock unit (“RSU”) awards to non-employee directors, officers, consultants
and employees. The aggregate fair value of the restricted stock unit awards granted was estimated to be $ 451,000 using the market price
of the stock on the date of the grant which is expensed using the straight-line method over the vesting period.
Schedule of Restricted Stock Units
Total
Restricted Stock Units Outstanding
Weighted
Average
Fair Value
Aggregate
Intrinsic
Value
Unvested December 31, 2024
164
$
1.76
$
-
Granted
-
-
-
Forfeited
( 9 )
-
-
Vested
-
-
-
Unvested and expected to vest at March 31, 2025
155
$
1.76
$
-
F- 10
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 months ended March 31, 2025
and 2024, equity-based compensation expense recorded was approximately $ 82,000 and $ 157,000 , respectively.
As of March 31, 2025, there was approximately $ 181,000
of total unrecognized compensation expense related to non-vested stock options that is expected to be recognized over a weighted average
period of .65 years. For options granted and outstanding, there were 548,855 options outstanding which were fully vested or expected to
vest, with an aggregate intrinsic value of $ 0.00 , a weighted average exercise price of $ 10.39 and weighted average remaining contractual
term of 6.86 years at March 31, 2025. For vested and exercisable options, outstanding shares totaled 475,480 , with an aggregate intrinsic
value of $ 0.00 . These options had a weighted average exercise price of $ 11.53 per share and a weighted-average remaining contractual
term of 6.66 years at March 31, 2025.
The aggregate intrinsic value of outstanding and exercisable
options at March 31, 2025 was calculated based on the closing price of the Company’s common stock as reported on The Nasdaq Capital
Market on March 31, 2025 of $ 1.42 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.
7. 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 8 –
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 September 30, 2027 and January 31, 2031, respectively. For operating leases, the weighted average discount rate is 6.4 % and the weighted average remaining lease term
is 5.0 years.
The following table summarizes the Company’s
maturities of operating lease liabilities, by year and in aggregate, as of March 31, 2025 (table in thousands):
Schedule of Maturities of Operating Lease Liabilities
2025 (excluding the three months ended March 31, 2025)
$ 306
2026
419
2027
415
2028
376
2029
249
2030 and thereafter
264
Total operating lease payments
2,029
Less: present value discount
( 296 )
Total operating lease liabilities
$ 1,733
As of March 31, 2025, the total operating lease liability
of $ 309 is classified as a current operating lease liability.
In April 2023, the Company renewed
its lease for the unit 100 at the Bothel, Washington facility (“Bothel 100”) for an 84-month (7 years) term, starting February
1, 2024, and ending on January 31, 2031. The Company classified the amended lease as an operating lease pursuant to the provisions of
ASC 842 and calculated the discounted value of the total lease payments to be approximately $ 1,224,000 using a discount rate of 6 % . This
amount was recognized as the lease liability and right-of use asset at the renewal date of the lease. As the renewal occurred in 2023,
the Company deemed it appropriate to recognize both the right-of-use asset and lease liability for the extension term in 2023, with no
amortization of the asset until the commencement of the extension term in February 2024.
In September 2023, following
the renewal of the Bothell 100 facility lease, the Company amended the agreement to expand the premises to include Suite 200 (“Bothell
200 facility”). The lease for the Bothell 200 facility has a 60-month (5-year) term, running from February 1, 2024, through January
31, 2029. The Company classified the lease as an operating lease and calculated the discounted value of the total lease payments to be
approximately $ 571,000 , using a 6 % discount rate. This amount was recognized as the lease liability and right-of-use asset at the
lease commencement date. As the lease for the Bothell 200 facility is tied to an existing lease and was executed in 2023, the Company
deemed it appropriate to recognize both the right-of-use asset and lease liability in 2023, with no amortization of the asset until the
lease term begins in February 2024.
In August 2024, the Company renewed its lease for
the Miami, Florida location for a 36-month term, starting from October 1, 2024, and ending on September 30, 2027, with an optional two-year
extension. At the time of renewal, the Company classified the lease as an operating lease pursuant to the provisions of ASC 842 and calculated
the discounted value of the total lease payments to be approximately $ 163,000 , using a discount rate of 10.75 % , and recognized this amount
as the lease liability and right-of-use asset at renewal date.
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 three months ended March
31, 2025 and 2024, approximately $ 39,000 and $ 55,000 of CAM was included in general and administrative operating expenses on the condensed
consolidated statements of operations, respectively.
The lessor of the Miami, Florida lease is a limited
liability company controlled by Dr. Phillip Frost, a director and a principal stockholder of the Company.
F- 11
For the three months ended March 31, 2025 and 2024,
operating lease expense, excluding short-term leases, finance leases and CAM charges, totaled approximately $ 103,000 and $ 87,000 , respectively,
of which $ 16,000 and $ 16,000 for each period was to a related party.
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 the reservation fee been fully expensed as of December 31, 2024, leaving no balance in
prepaid and other expenses as of the prior year then ended.
The total estimated cost of the agreement (including
the reservation fee) is approximately $ 6.9 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.
8. Transactions with Related Parties
On August 14, 2024, 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 $ 64,000 including fixed and estimable fees and taxes. Upon the extension of the lease,
the Company recognized a right-of-use asset of approximately $ 163,000 . The discount rate used to measure the lease assets and liabilities
for the extension was 10.75 %.
The Company paid a lease deposit of $ 4,000 on the original agreement and
total rent and other expenses paid in connection with this lease were $ 16,000 and for the three months ended March 31, 2025 and 2024 respectively.
9. Segment Information
The Company operates and manages its business as
one 1 reportable and operating segment dedicated to the
research and development Company’s novel orally administered antiviral influenza candidate. The measure of segment assets is reported
on the balance sheet as total consolidated assets. In addition, the Company manages the business activities on a consolidated basis.
The Company’s CODM reviews financial information
presented on a consolidated basis and decides how to allocate resources based on net income (loss).
Significant segment expenses include research and
development, salaries, insurance, and stock-based compensation. Operating expenses include all remaining costs necessary to operate our
business, which primarily include external professional services and other administrative expenses. The following table presents the significant
segment expenses and other segment items regularly reviewed by our CODM (table in thousands):
Schedule
of Segment Information
2025
2024
Three months ended March 31,
2025
2024
Revenue
$ -
$ -
Less:
Research and development
1,027
2,509
Salaries and personnel costs
544
656
Insurance
62
77
Stock-based compensation
82
157
Operating expenses
625
759
Other income
( 39 )
( 202 )
Net loss
$ 2,301
$ 3,956
10. Subsequent Events
On April 2, 2025, our board of directors
approved an Equity Incentive Plan (the “2025 Plan) that remains subject to shareholder approval and ratification. The 2025
Plan provides for the grant of incentive stock options, qualified stock options, restricted stock awards, restricted stock units,
stock appreciation rights, and performance shares or units and cash awards. Awards may be granted under the 2025 Plan to our
employees, directors and independent contractors. the aggregate number of shares of Common Stock which shall be available
for grants or payments of Awards under the 2025 Plan during its term shall initially be 1,500,000 (the “Total Plan Shares”).
The Total Plan Shares will automatically increase on January 1st of each year, for a period of nine years commencing on January
1, 2026, in an amount equal to 5 %
of the total number of shares of Common Stock outstanding as of December 31 of the preceding calendar year on a fully diluted
basis. The 2025 Plan also provides that, notwithstanding the annual increase provision, in no event will the increase in
Total Plan Shares available under the 2025 Plan pursuant to the increase provision exceed 2,500,000 additional shares (or a total of up
to 4,000,000 Total Plan Shares), subject to adjustment as provided under the 2025 Plan. The 2025 Plan is effective as of March 31, 2025;
however, the 2025 Plan is subject to approval of our stockholders which the Company is seeking at its annual meeting of stockholders schedule
for June 25, 2025. The prior 2015 Plan expires on June 29, 2025. See Note 6.
F- 12
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 believes that inflation has not 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 particularly based upon United States tariff policy, 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 three months ended March 31, 2025 and
more recently the Company continued to focus its research and development efforts primarily in three areas of norovirus, coronavirus
and influenza.
Influenza Program
We have several candidates under development for the
treatment of influenza infection. CC-42344, a novel PB2 inhibitor, was selected as a preclinical lead as an oral or inhaled treatment
of pandemic and seasonal influenza A. 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 addition to the oral candidate of CC-42344, inhaled
CC-42344 is being developed for the potential prophylactic treatment of pandemic and seasonal influenza infections. Dry powder inhalation
development and toxicology studies have been evaluated.
We received authorization from the United Kingdom
Medicines and Healthcare Products Regulatory Agency (MHRA) to conduct a Phase 2a human challenge study with oral CC-42344 as a potential
treatment for pandemic and seasonal influenza A. This randomized, double-blind, placebo-controlled study is designed to evaluate the safety,
tolerability, viral and clinical measurements of healthy subjects infected with the influenza A virus dosed with oral CC-42344 treatment.
In May 2024 we announced the completion of enrollment of 78 subjects.
3
In December 2024, the Company announced plans to extend
enrollment for the oral CDI-42344 Phase 2a study due to an unexpectedly low influenza infection among study participants. Specifically,
management determined that an extension of the study is necessary due to low infectivity rate of the challenge influenza strain used in
this study, as the establishment of robust influenza infection in healthy, uninfected study subjects is critical to determine clinical
endpoints for evaluating antiviral molecule, and the low infectivity obtained in this study hindered antiviral data analysis. The Company
is currently in continuing discussions with the clinical research organization to address this study and determine a course forward with
respect thereto, including potentially preparing a protocol amendment or a resubmission for approval by the MHRA in order to seek enrollment
of additional healthy subjects infected with the influenza A virus to ensure necessary infection rates to secure sufficient data for analysis.
CC-42344 has demonstrated favorable safety and tolerability profile from the Phase 2a study to date, with no SAEs and no drug-related
discontinuations by study participants.
In June 2024 we reported the potential efficacy of
CC-42344 against the new Texas avian flu strain from in vitro studies with the recently published genome sequence for
H5N1. Using our proprietary structure-based platform technology, the Company reported a high-resolution cocrystal structure of this avian
PB2 protein complexed with CC-42344 and confirmed that CC-42344 binds to its highly conserved PB2 region. The in vitro data
using purified Texas avian H5N1 PB2 protein further showed in vitro affinity of CC-42344 similar to that of previous data using
pandemic avian and seasonal influenza A PB proteins.
We also continue developing novel broad-spectrum influenza
antivirals targeting replication enzymes of seasonal and pandemic influenza A and B strains.
Norovirus and Coronavirus Programs
We developed the novel protease inhibitor CDI-988
as an oral pan-viral treatment of noroviruses and coronaviruses, including SARS-CoV-2 and its variants. CDI-988 was specifically designed
and developed using our proprietary structure-based drug discovery platform technology as a broad-spectrum antiviral inhibitor to a highly
conserved region in the active site of noroviruses, coronaviruses and other 3CL viral proteases. We believe CDI-988 represents a first-in-class
pan-viral antiviral for the treatment of viral gastroenteritis caused by noroviruses and coronaviruses, including SARS-CoV-2 and its variants.
Oral CDI-988 is being clinically evaluated for safety,
tolerability and pharmacokinetics including a food-effect cohort in healthy volunteers in a single-center, randomized, double-blind, placebo-controlled
Phase 1 study being conducted in Australia. We expect that the oral CDI-988 Phase 1 data will support future norovirus
and coronavirus Phase 2 and Phase 3 studies.
In July 2024 we announced favorable safety and tolerability
results from the single-ascending dose (SAD) cohorts of the Phase 1 study with CDI-988. Study participants in the SAD cohorts received
CDI-988 in doses ranging from 100 mg to 600 mg. All participants completed the study with no discontinuations. There were no serious adverse
events or severe treatment-emergent adverse events. No clinically significant observations were noted in laboratory assessments, physical
exams or electrocardiograms.
In September 2024 we initiated dosing of the first
subjects in the multiple-ascending dose (MAD) portion of the Phase 1 study with CDI-988. In January 2025 we reported topline results from
the MAD portion of the Phase 1 study showing that CDI-988 administered at 800 mg, the highest dose tested, for 10 consecutive days was
safe and well tolerated. We also announced an additional cohort for a higher dose of 1,200 mg and a shorter treatment duration of five
consecutive days to further assess CDI-988’s safety, tolerability and pharmacokinetics. Results from the high-dose cohort are expected
to be released in the first half of 2025.
4
Therapeutic Targets
Influenza: A worldwide public health problem,
including the potential for pandemic Avian Flu
Influenza is a severe respiratory illness, caused
primarily by influenza A or B viruses. Influenza A viruses are the only influenza viruses known to cause influenza pandemics. Each year
there are approximately 1 billion cases of seasonal influenza worldwide, with 3-5 million severe illnesses and up to 650,000 deaths, according
to the World Health Organization (“WHO”). On average about 8% of the U.S. population contracts influenza each season, according
to the Centers for Disease Control and Prevention (“CDC”). In addition to the health risk, influenza is responsible for approximately
$10.4 billion in direct medical costs in the U.S. annually, according to the National Institutes of Health (“NIH”).
Currently approved antiviral treatments for influenza
are effective but burdened with significant viral resistance. Strains of influenza virus resistant to the approved treatments oseltamivir
phosphate (Tamiflu®), zanamavir (Relenza®) and baloxavir marboxil (Xofluza®) have appeared and in some cases are predominant.
For example, the predominant strain of the 2009 swine influenza pandemic was resistant to oseltamivir. Oseltamivir inhibits influenza
neuraminidase enzymes, which are not highly conserved between viral strains. According to the WHO, approximately 15% of the H1N1 isolates
circulating worldwide were oseltamivir resistant. Also, treatment-emergent resistance to recently approved baloxavir has been observed
during clinical trials and the potential transmission of resistant influenza variants could significantly diminish baloxavir effectiveness.
Norovirus: A worldwide public health problem
responsible for close to 90% of the global epidemic, non-bacterial outbreaks of gastroenteritis with no effective treatment or vaccine
Norovirus is a very common and highly contagious virus
that causes symptoms of acute gastroenteritis among people of all ages including nausea, vomiting, stomach pain and diarrhea as well as
fatigue, fever and dehydration. Norovirus infection can be significantly more severe and prolonged in specific risk groups including infants,
children, the elderly and people with immunodeficiency. In immunosuppressed patients, chronic norovirus infection can lead to a debilitating
illness with extended periods of nausea, vomiting and diarrhea. Norovirus outbreaks occur most commonly in semi-closed communities and
have become notorious for their occurrence in hospitals, nursing homes, childcare facilities, cruise ships, schools, disaster relief sites
and military settings.
In the U.S. alone, noroviruses are
the leading cause of vomiting and diarrhea from acute gastroenteritis among people of all ages and responsible for an estimated
21 million cases annually, including 109,000 hospitalizations, 465,000 emergency department visits and an estimated 900 deaths, according
to the CDC. The NIH estimates the annual burden to the United States at $10.6 billion.
According
to the CDC, noroviruses average 685 million cases of acute gastroenteritis worldwide. Noroviruses are responsible for up to 1.1
million hospitalizations and 218,000 deaths annually in children in the developing world.
There is currently no effective treatment or effective
vaccine for norovirus, and the ability to curtail outbreaks is limited. We are developing a novel norovirus antiviral candidate for the
prophylactic and therapeutic treatment of norovirus infection that is currently in a Phase 1 clinical study. A few companies have been
developing vaccines and are in stages of clinical testing, including Vaxart Pharmaceutical, Moderna, Hillevax, Takeda Pharmaceuticals,
Anhui Zhifei Longcom Biopharmaceutical (China) and National Vaccine and Serum Institute (China).
Coronavirus: COVID-19 continues to be a global
pandemic fueled by an emergence of new strains
COVID-19 is a global health concern responsible for
more than 777 million reported cases globally, including more than 7 million deaths, as of March 2025, according to data reported by the
WHO.
Coronaviruses (CoV) are a large family of RNA viruses
that historically have been associated with illness ranging from mild symptoms similar to the common cold to more severe respiratory disease.
Infection with the novel SARS-CoV-2 has been associated with a wide range of responses, from no symptoms to more severe disease that has
included pneumonia, severe acute respiratory syndrome, kidney failure, and death. The incubation period for SARS-CoV-2 is believed to
be within 14 days after exposure, with most illness occurring within about five days after exposure. SARS-CoV-2, like other RNA viruses,
is prone to mutate over time, resulting in the emergence of multiple variants. Adaptive mutations in the viral genome can alter the virus’s
pathogenic potential. Even a single amino acid exchange can drastically affect a virus’s ability to evade the immune system and
complicate the vaccine and antibody therapeutics development against the virus. Based on an epidemiological update by the WHO, five SARS-CoV-2
VOCs (variants of concern) have been identified since the beginning of the pandemic. Also, as demonstrated in the Delta, Omicron and other
variants, some variations allow the virus to spread more easily and make it resistant to the treatments and vaccines.
5
On October 22, 2020, the U.S. Food and Drug Administration
(“FDA”) approved the antiviral drug Veklury® (remdesivir) for the treatment of COVID-19 requiring hospitalization. Remdesivir
is a nucleotide prodrug that inhibits viral replication and was previously evaluated in clinical trials for Ebola treatment in 2014. On
May 25, 2023, the FDA approved Paxlovid™ (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment
of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. For
certain hospitalized adults with COVID-19, the FDA has also approved Olumiant® (baricitinib) and Actemra® (tocilizumab). In addition,
the FDA issued emergency use authorization (EUA) for several antibody and antiviral therapeutics, including and Lagevrio™ (molnupiravir).
We continue pursuing the development of novel antiviral
compounds for the treatment of coronavirus infections using our established proprietary drug discovery platform. By targeting the viral
replication enzymes and protease, we believe it is possible to develop an effective treatment for all coronavirus diseases including COVID-19,
Severe Acute Respiratory Syndrome (SARS), and Middle East Respiratory Syndrome (MERS).
Hepatitis C: A large competitive market with
opportunity for shorter treatment regimens
HCV is a highly competitive and changing market. Since
2014, several combinations of direct-acting antiviral agents (“DAAs”) have been approved for the treatment of HCV infection.
These include Harvoni (sofosbuvir/ledipasvir) 12 weeks of treatment, Viekira Pak (ombitasvir/paritaprevir/ritonavir, dasabuvir) twelve
weeks of treatment, Epclusa (sofosbuvir/velpatasvir) twelve weeks of treatment, Zepatier (elbasvir/grazoprevir) twelve weeks of treatment
and Mavyret (glecaprevir/pibrentasvir) eight weeks of treatment. We believe the next improvements in HCV treatment will be ultra-short
combination oral treatments of four to six weeks, which is the goal of our program.
We anticipate a significant global HCV market opportunity
that will persist through at least 2036, given the large prevalence of HCV infection worldwide. The 2024 World Health Organization Global Hepatitis Report estimates that 50 million people worldwide have chronic
HCV infections with about 1 million new infections occurring per year and an estimated 3.2 million adolescents and children with chronic
HCV infection. In July 2023, WHO published that globally, an
estimated 58 million people have chronic HCV infection, with about 1.5 million new infections occurring per year, and an estimated 3.2
million adolescents and children with chronic HCV infection.
We are targeting the viral NS5B polymerase with an
NNI, which could be developed as part of an all-oral, pan-genotypic combination regimen. Our focus is on developing what is now called
ultrashort treatment regimens from four to six weeks in length. Such a combination treatment CC-31244 with different classes of approved
DAAs has the potential to change the paradigm of treatment for HCV with a shorter duration of treatment. Combination strategies with approved
drugs could allow us to expand CC-31244 into the HCV antiviral therapeutic area globally and could lead to a high and fast cure rate,
to improved compliance, and to reduced treatment duration. To our knowledge no competing company has yet developed a short HCV treatment
of less than 8 weeks with a high (>95%) sustained virologic response (SVR) at week 12.
CC-31244, an HCV NNI, is a potential best in class
pan-genotypic inhibitor of NS5B polymerase for the treatment of HCV. The Company completed a Phase 1a/b study in Canada in September 2016,
with favorable safety results in a randomized, double-blinded, Phase 1a/b study in healthy volunteers and HCV-infected subjects. The Company
completed a Phase 2a study in HCV genotype 1 subjects in the United States. Cocrystal presented the interim results from the Phase1a/b
study at the APASL in February 2017. HCV-infected subjects treated with CC-31244 had a rapid and marked decline in HCV RNA levels, and
slow viral rebound after treatment. Results of this study suggest that CC-31244 could be an important component in a shortened duration
all-oral HCV combination therapy. The Company has completed the Phase 2a final study report as filed with the FDA. See “Item 1 –
Business – Research and Development Update – Hepatitis C” in our Annual Report on Form 10-K for the year ended December
31, 2024 for more information.
The Company has been seeking a partner for further
clinical development of CC-31244 since completing Phase 2a trials.
6
Results of Operations for the Three Months Ended
March 31, 2025 compared to the Three Months Ended March 31, 2024
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 March 31, 2025, and 2024 were $1,360,000 and $2,950,000, respectively. The decrease of $1,590,000 was primarily due to a
reduction in salary and related costs and our Influenza CC-42344 product candidate moving out of Phase 2a clinical trial and the finalizing
of the Phase 1 clinical trial of norovirus and coronavirus candidate CDI-988.
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 March 31, 2025, and 2024 were $981,000 and $1,208,000, respectively. The decrease of $227,000 was due to a reduction in insurance
cost and other general and administrative expense.
Interest Income, Net
Interest income for the three months ended March 31,
2025 and 2024 was $37,000 and $220,000, respectively. The interest income was primarily earned on cash held in interest bearing bank accounts.
Other Income (Expense)
During the
period ending March 31, 2024, the Company had 11,000 warrants accounted as liabilities that expired; no warrants remain outstanding
at this time.
In 2022, the Company established
a wholly owned subsidiary in Australia, making it subject to foreign exchange rate fluctuations. Foreign exchange gain of $3,000 was recorded
for the three months ended March 31, 2025 compared to a foreign exchange loss of $18,000 during the three months ended March 31, 2024.
Income Taxes
No income tax benefit or expense was recognized for
the three months ended March 31, 2025 and 2024. The Company’s effective income tax rate was 0.00% for the three months
ended March 31, 2025 and 2024. 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 months ended March 31, 2025 was $2,301,000 compared with a net loss of $3,956,000 for the
three months ended March 31, 2024, respectively, as a result of developments related to our expenses described above.
Liquidity and Capital Resources
Net cash used in
operating activities was $2,939,000 for the three months ended March 31, 2025 compared with net cash used in operating activities of
$4,503,000 for the same period in 2024. This decrease was primarily due to decrease in period expenses related to our Influenza A
Phase 2a clinical trial.
No cash was used for investing
activities during the three months ended March 31, 2025 compared with $8,000 net cash used for the same period in 2024. For the three
months ended March 31, 2025 the level of investments decreased compared with March 31, 2024 due to comparative reduction in purchases
of laboratory equipment in 2025.
No cash was used for
financing activities during the three months ended March 31, 2025 and for the same period in 2024 due to sufficient capital
resulting in a lack of financing activity in the 2025 period.
The Company has not yet
established an ongoing source of revenue sufficient to cover its operating costs. The Company had $6,921,000 unrestricted cash on March
31, 2025. We expect that our reported cash balance is not be sufficient to support the Company’s working capital needs for the
12 months following the filing of this report, taking into account our intended research and development efforts in the remainder of
2025 and beyond.
Developing pharmaceutical products,
including conducting preclinical studies and clinical trials, is capital-intensive. As a rule, research and development expenses increase
substantially as a company advances a product candidate toward clinical programs. Historically, we have financed our operations with the
proceeds from public and private equity and debt offerings, including additional investments by certain existing stockholders, and entered
into strategic partnerships and collaborations for the research, development and commercialization of product candidates.
7
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. On May 24, 2023, the Company filed a prospectus supplement covering sales under the ATM
Agreement under which we may offer and sell shares of our common stock having an aggregate offering price of up to $7,250,000 from time
to time through Wainwright. There were no sales under the ATM Agreement during the three months ended March 31, 2025.
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.
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 and progressing our
programs in the clinical development process generally, 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 the possibility of a recession,
interest rate increases, and the economic impact of United States tariff policies geopolitical conflicts including inflation, 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 contract research
organizations (CROs) and contract manufacturing organizations (CMOs), the progress and results of the studies for CC-42344 and
CDI-988 including the delay of the Phase 2a study for CC-42344 which may require us to incur substantial additional costs, the
results of the studies for CC-42344 and CDI-988 and any future preclinical and clinical trials, the ability of our CROs to recruit
volunteers for, and to proceed with, clinical studies, and our collaboration partners’ technology and software performing as
expected, financial difficulties experienced by certain partners, general risks arising from clinical trials, receipt of regulatory
approvals and changes including based on initiatives and actions taken by the Trump Administration which could, among other things,
result in delays in regulatory approvals or limit access to federal funding for our programs regulatory changes, development of
effective treatments and/or vaccines by competitors, including as part of the programs financed by governmental authorities and
potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop.
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, 2024. We undertake no obligation to publicly update or revise any forward-looking statements, whether as the
result of new information, future events or otherwise.
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Critical Accounting Policies and Estimates
In our Annual Report on Form 10-K for the year ended
December 31, 2024, 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, 2024 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 March 31, 2025 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, 2025. 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, 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, 2024.
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
During the three months ended March 31, 2025, none
of our directors or officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated any contract, instruction or written
plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under
the Exchange Act or any “non-Rule 10b5-1 arrangement” as defined in Item 408(c) of Regulation S-K.
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.
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.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange
Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Cocrystal Pharma, Inc.
Dated: May 15, 2025
By:
/s/ Sam Lee
Sam Lee
President and Co-Chief Executive Officer
(Principal Executive Officer)
Dated: May 15, 2025
By:
/s/ James Martin
James Martin
Chief Financial Officer and Co-Chief Executive Officer
(Principal Executive Officer and Principal Financial Officer)
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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.