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, 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 November 14, 2025, the number of outstanding shares of the registrant’s common stock, par value $ 0.001 per share, was approximately
13,784,065 .
COCRYSTAL
PHARMA, INC.
FORM
10-Q FOR THE QUARTER ENDED SEPTEMBER 30, 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
10
Item 4. Controls and Procedures
10
Part II - OTHER INFORMATION
Item 1. Legal Proceedings
11
Item 1. A. Risk Factors
11
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
11
Item 3. Defaults Upon Senior Securities
11
Item 4. Mine Safety Disclosures
11
Item 5. Other Information
11
Item 6. Exhibits
12
SIGNATURES
12
2
Part
I – FINANCIAL INFORMATION
COCRYSTAL
PHARMA, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands, except per share data)
September 30, 2025
December 31, 2024
(unaudited)
Assets
Current assets:
Cash
$ 7,729
$ 9,860
Restricted cash
75
75
Tax credit receivable
513
1,215
Prepaid expenses and other current assets
465
430
Total current assets
8,782
11,580
Property and equipment, net
106
153
Deposits
90
29
Operating lease right-of-use assets, net (including $ 115 and $ 152 respectively, to related party)
1,468
1,694
Total assets
$ 10,446
$ 13,456
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses
$ 1,194
$ 2,127
Current maturities of operating lease liabilities (including $ 54 and $ 49 respectively, to related party)
326
301
Total current liabilities
1,520
2,428
Long-term liabilities:
Operating lease liabilities (including $ 63 and $ 104 respectively, to related party)
1,257
1,505
Total liabilities
2,777
3,933
Commitments and contingencies (Note 7)
-
-
Stockholders’ equity:
Common stock, $ 0.001 par value 100,000 shares authorized as of September 30, 2025 and December 31, 2024; 13,041 and 10,174 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively
13
10
Additional paid-in capital
347,479
342,931
Accumulated deficit
( 339,823 )
( 333,418 )
Total stockholders’ equity
7,669
9,523
Total liabilities and stockholders’ equity
$ 10,446
$ 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
2025
2024
Three months ended September 30,
Nine months ended September 30,
2025
2024
2025
2024
Operating expenses:
Research and development
954
3,242
3,436
10,500
General and administrative
1,135
1,800
3,102
4,148
Total operating expenses
2,089
5,042
6,538
14,648
Loss from operations
( 2,089 )
( 5,042 )
( 6,538 )
( 14,648 )
Other income (expense):
Interest income
22
111
87
482
Foreign exchange gain (loss)
18
( 8 )
46
( 72 )
Total other income, net
40
103
133
410
Net loss
$ ( 2,049 )
$ ( 4,939 )
( 6,405 )
( 14,238 )
Net loss per common share, basic and diluted
$ ( 0.19 )
$ ( 0.49 )
( 0.61 )
( 1.40 )
Weighted average number of common shares, basic and diluted
10,991
10,174
10,449
10,174
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, 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
Stock-based compensation
-
-
84
-
84
Net loss
-
-
-
( 2,055 )
( 2,055 )
Balance as of June 30, 2025
10,174
$ 10
$ 343,097
$ ( 337,774 )
$ 5,333
Sale of common stock in ATM, net of transaction cost
85
-
154
-
154
Sale of common stock in SPA, net of transaction costs
2,765
3
4,180
-
4,183
Exercise of RSU
17
-
-
-
-
Stock-based compensation
-
-
48
-
48
Net loss
-
-
-
( 2,049 )
( 2,049 )
Balance as of September 30, 2025
13,041
$ 13
$ 347,479
$ ( 339,823 )
$ 7,669
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
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
Stock-based compensation
-
-
148
-
148
Net loss
-
-
-
( 5,343 )
( 5,343 )
Balance as of June 30, 2024
10,174
$ 10
$ 342,593
$ ( 325,213 )
$ 17,390
Balance
10,174
$ 10
$ 342,593
$ ( 325,213 )
$ 17,390
Stock-based compensation
-
-
252
-
252
Net loss
-
-
-
( 4,939 )
( 4,939 )
Balance as of September 30, 2024
10,174
$ 10
$ 342,845
$ ( 330,152 )
$ 12,703
Balance
10,174
$ 10
$ 342,845
$ ( 330,152 )
$ 12,703
See
accompanying notes to condensed consolidated financial statements.
F- 3
COCRYSTAL
PHARMA, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in
thousands)
2025
2024
Nine months ended September 30,
2025
2024
Operating activities:
Net loss
$ ( 6,405 )
$ ( 14,238 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense
59
98
Right of use assets
226
247
Stock-based compensation
214
558
Operating lease liabilities
( 223 )
( 142 )
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
( 96 )
1,281
Tax credit receivable
702
238
Accounts payable and accrued expenses
( 933 )
( 1,367 )
Net cash used in operating activities
( 6,456 )
( 13,325 )
Investing activities:
Purchases of property and equipment
( 12 )
( 8 )
Net cash used in investing activities
( 12 )
( 8 )
Financing activities:
Proceeds from ATM sale of common stock, net of transaction costs
154
-
Proceeds from registered direct sale of common stock, net of transaction cost
4,183
-
Net cash provided by financing activities
4,337
-
Net decrease in cash and restricted cash
( 2,131 )
( 13,333 )
Cash and restricted cash at beginning of period
9,935
26,428
Cash and restricted cash at end of period
$ 7,804
$ 13,095
Supplemental disclosure:
Non-cash investing and financing activities
Initial recognition of right-of-use assets and lease liabilities
$ -
$ 163
See
accompanying notes to condensed consolidated financial statements.
F- 4
COCRYSTAL
PHARMA, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE NINE MONTHS ENDED SEPTEMBER 30, 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 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 performing research and development, raising capital, and acquiring
product and technology rights. 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 nine months ended
September 30, 2025, the Company recorded a net loss of approximately $ 6,405,000 and used approximately $ 6,456,000 of cash in operating
activities. These factors raise substantial doubt about the Company’s ability to continue as a going concern.
On
September 30, 2025, the Company had cash and restricted cash of approximately $ 7,804,000 . 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. As a result, management has concluded that there is substantial doubt about the Company’s ability to continue
as a going concern. The accompanying consolidated financial statements do not include any adjustments relating to the recoverability and
classification of recorded assets, or the amounts and classification of liabilities that might be necessary in the event the company cannot
continue as a going concern. The Company’s independent registered public accounting firm, in its report on the Company’s consolidated
financial statements for the year ended December 31, 2024, has also expressed substantial doubt about the Company’s ability to continue
as a going concern.
The
Company’s activities since inception have principally consisted of performing research and development, raising capital, and acquiring
product and technology rights. 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, 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 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.
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 two 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, 2025 and December 31, 2024, our primary operating accounts held approximately $ 7,729,000 and
$ 9,860,000 , respectively, and our restricted cash 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.
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
At
September 30, 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, included in the balance of Tax
credit receivable is the balance of the Refundable Tax Credits of approximately $ 1,123,800 ,
which was received in full as of September 30, 2025. The Company estimated and accrued Refundable Tax Credits for the nine months
ended September 30, 2025 of approximately $ 513,231 ,
resulting in a net balance of Refundable Tax Credits receivable of approximately $ 513,231 .
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, 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 nine months ended September 30, 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.
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 warrants.
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
September 30,
2025
2024
Outstanding options to purchase common stock
537
555
Outstanding restricted stock units
230
256
Warrants to purchase common stock
5,737
-
Total
6,504
811
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 ( 3 three
to five
years ) using the straight-line method. As of September 30, 2025, and December 31, 2024, property and equipment consist of
(table in thousands):
Schedule of Property and Equipment
September 30, 2025
December 31, 2024
Lab equipment
$ 1,777
$ 1,765
Finance lease right-of-use lab equipment
162
162
Computer and office equipment
155
155
Total property and equipment
2,094
2,082
Less: accumulated depreciation and amortization
( 1,988 )
( 1,929 )
Property and equipment, net
$ 106
$ 153
Total
depreciation and amortization expense were approximately $ 59,000 and $ 98,000 for the nine months ended September 30, 2025 and 2024.
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, 2025
December 31, 2024
Accounts payable
$ 745
$ 1,542
Accrued compensation
127
117
Accrued other expenses
322
468
Total accounts payable and accrued expenses
$ 1,194
$ 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
As
of September 30, 2025, the Company has authorized 100,000,000 shares of common stock, $ 0.001 par value per share, and 1,000,000 shares
of preferred stock, $ 0.001 par value per share.
The
Company had 13,041,000 and 10,174,000 shares of common stock and no shares of preferred stock issued and outstanding as of September
30, 2025, and December 31, 2024, respectively.
The
holders of common stock are entitled to one vote for each share of common stock held.
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. The Company sold 85,076 shares
of its common stock at an average price of $ 1.88 under
the ATM agreement during the three and nine months ended September 30, 2025. As of the date of this report, the Company has sold a
total 1,200,152 shares
of its common stock for total net proceeds of approximately $ 2,380,000 pursuant
to the ATM Agreement. On September 12, 2025, the Company and Wainwright agreed to terminate the sales of shares under the ATM Agreement
and filed a prospectus supplement with the SEC to that effect. As a result of this, the at-the-market offering under the ATM Agreement
is no longer ongoing as of September 12, 2025, and the Company will not make any sales of common stock pursuant to the ATM Agreement unless
and until a new prospectus supplement is filed with the SEC; however, the ATM Agreement remains in full force and effect.
On
September 12, 2025, the Company, entered into a securities purchase agreement with certain accredited investors, pursuant to which
the Company sold to the investors (i) in a registered direct offering, an aggregate of 2,764,710 shares
of the Company’s common stock, at a price of $ 1.70 per
share and (ii) in a concurrent private placement, warrants to purchase up to an aggregate of 5,529,420 shares
of common stock (“the Investor Warrants”), at an initial exercise price of $ 1.50 per
share. The Investor Warrants are exercisable upon issuance and will expire on September 27, 2027. Wainwright acted as the
Company’s placement agent in connection with this offering. The
Company paid Wainwright consideration consisting of (i) a cash fee equal to 7.0% of the aggregate gross proceeds in the offering,
(ii) a management fee equal to 1.0% of the aggregate gross proceeds in the offering, (iii) reimbursement of certain expenses and
(iv) warrants to acquire up to an aggregate of 207,353
shares of common stock (the “Placement Agent Warrants”). The Placement Agent Warrants are similar to the Investor
Warrants, except that the initial exercise price of the Placement Agent Warrants is $ 2.125
per share. The Company received net proceeds of $ 4,183,000 from the sale of its common shares and warrants in the direct offering.
Warrant
Activity Table:
Schedule
of Warrant
Shares
Underlying Warrants
Weighted
Average
Exercise Price
Aggregate
Intrinsic
Value
Outstanding
as of December 31, 2024
-
$ -
$ -
Granted
5,736,773
1.52
-
Exercised
-
-
-
Forfeited
-
-
-
Outstanding
as of September 30, 2025
5,736,773
$ 1.52
$ -
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. The 2015 Plan expired on June 29, 2025 and no
further equity awards will be issued under the 2015 Plan.
On
June 25, 2025, our stockholders approved and ratified an Equity Incentive Plan (the “2025 Plan”). 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.
On
April 2, 2025, the Board of Directors of the Company approved and adopted the 2025 Plan, which has an effective date of March 31, 2025.
On June 25, 2025, the 2025 Plan was approved by our stockholders at our annual meeting of stockholders.
As
of September 30, 2025 there have been no equity awards issued under the 2025 Plan.
Common
Stock Reserved for Future Issuance for Equity Incentive Plans
The
following table presents information concerning common stock available for future issuance (in thousands) as of September 30, 2025:
Schedule of Common Stock Available
for Future Issuance
Shares Available for Grant
Balance at December 31, 2024
27
2015 Plan expiration
( 27 )
2025 Plan addition
1,500
Balance at September 30, 2025
1,500
Stock
Options
The
following table summarizes stock option transactions for the 2015 Plan, collectively, for the nine months ended September 30, 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
( 13 )
-
-
Balance at September 30, 2025
537
$ 8.91
$ -
F- 10
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
Outstanding as of December 31, 2024
256
$ -
$ -
Exercised
( 17 )
1.76
-
Forfeited
( 9 )
1.76
-
Vested
( 117 )
1.76
-
Unvested and expected to vest at September 30, 2025
113
$ 1.76
$ -
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, 2025 and 2024, equity-based compensation
expense recorded on vested options and RSU was $ 48,000 and $ 214,000 and $ 252,000 and $ 557,000 respectively.
As
of September 30, 2025, there was approximately $ 86,000 of total unrecognized compensation expense related to non-vested stock options
that is expected to be recognized over a weighted average period of 0.5 years. For options granted and outstanding, there were 537,000
outstanding options which were fully vested or expected to vest, with an aggregate intrinsic value of $ 0.00 , a weighted average exercise
price of $ 8.91 and weighted average remaining contractual term of 6.49 years at September 30, 2025. For vested and exercisable options,
outstanding shares totaled 499,000 , with an aggregate intrinsic value of $ 0.00 . These options had a weighted average exercise price of
$ 9.39 per share and a weighted-average remaining contractual term of 6.40 years at September 30, 2025.
The
aggregate intrinsic value of outstanding and exercisable options at September 30, 2025 was calculated based on the closing price of the
Company’s common stock as reported on The Nasdaq Capital Market on September 30, 2025 of $1.25 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.
F- 11
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 4.5 years.
The
following table summarizes the Company’s maturities of operating lease liabilities, by year and in aggregate, as of September 30,
2025 (table in thousands):
Schedule of Maturities of Operating Lease Liabilities
2025 (excluding the nine months ended September 30, 2025)
$ 102
2026
419
2027
415
2028
376
2029 and Thereafter
513
Total operating lease payments
1,825
Less: present value discount
( 242 )
Total operating lease liabilities
$ 1,583
As
of September 30, 2025, $ 326,000 is classified as a current operating lease liability.
F- 12
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 is 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, 2025 and 2024, approximately $ 125,000 and $ 134,000 of CAM was included in general
and administrative operating expenses on the condensed consolidated statements of operations, respectively.
On
September 21, 2023, the Company amended the lease agreement with a North Creek Tec LLC, to expand its laboratory facility in Bothell
– WA, with additional 6,000 sq ft for a period of 5 years that expires on January 31, 2029 , with monthly lease payments under this
lease totaling $ 660,000 . In addition, the Company amended the lease agreement to extend the original laboratory facility for an additional
7 years with monthly lease payments under this lease totaling $ 1,498,000 . Through January 2031 , the minimum lease payment combined totals
approximately $ 380,000 annually.
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.
For
the nine months ended September 30, 2025 and 2024, operating lease expense, excluding short-term leases, finance leases and CAM charges,
totaled approximately $ 308,000 and $ 291,000 , respectively, of which $ 48,000 and $ 46,000 for each period was to a related party.
The
lessor of the Miami, Florida lease is a limited liability company controlled by Dr. Phillip Frost, a director and principal stockholder
of the Company.
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 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.
F- 13
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 $ 48,000 and $ 46,000 for the nine months ended September 30, 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
Nine
months ended September 30,
2025
2024
Research
and development
2,737
9,040
Salaries
and personnel costs
1,171
2,403
Insurance
185
224
Stock-based
compensation
214
557
Operating
expenses
2,231
2,424
Other
income
( 133
)
( 410
)
Net
loss
$
6,405
$
14,238
10.
Subsequent Event
On
October 28, 2025, we entered into a securities purchase agreement with four accredited investors under which the investors purchased a total of 739,426 units of the Company’s securities. The units were priced at-the-market
under the rules of The Nasdaq Stock Market at a purchase price of $ 1.39 per unit. Each unit consisted of one share of common stock and
one warrant to purchase two shares of common stock at an exercise price of $ 1.24 per share over a 27 -month period. The investors did
not receive registration rights. The gross proceeds were $ 1.03 million. The investors were four insiders of the Company.
On October 27, 2025, the Company issued a press release
announcing it has received a $ 500,000 Small Business Innovation
Research (“SBIR”) Phase I award from the National Institutes of Health (“NIH”) and the National Institute of
Allergy and Infectious Diseases (NIAID). The NIH/NIAID Phase I award is designed to assess the scientific, technical and commercial potential
of early-stage programs and will support the Company’s development of a novel, oral, broad-spectrum antiviral candidate for the
treatment of influenza A and B infections.
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 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”).
Research
and Development Update
During
the nine months ended September 30, 2025 the Company continued to focus its research and development efforts primarily in three areas.
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 completed.
In
June 2024, we reported the potential efficacy of CC-42344 against the Texas avian flu strain from in vitro studies with the 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. In May 2025, we further demonstrated the in vitro
efficacy of CC-42344 against the highly pathogenic H5N1 avian influenza A strain (A/Texas/37/2024). The data showed that CC-42344 is
highly potent against the H5N1 avian influenza strain (EC50, 0.003 µM), consistent with the previous biochemical data.
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 was 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.
The
oral CC-42344 Phase 2a study was completed .
CC-42344 has demonstrated favorable safety and tolerability profile from the Phase 2a study, with no SAEs and no
drug-related discontinuations by study participants. We plan to continue development of oral CC-42344 as a treatment for pandemic
and seasonal influenza A.
3
We
also continue developing novel broad-spectrum influenza antivirals targeting replication enzymes of pandemic and seasonal influenza A
and B strains. In January 2019 our influenza A/B antiviral preclinical development assets were licensed pursuant to a collaboration agreement
(“Collaboration”) with Merck Sharp & Dohme Corp. (“Merck”). The property developed in the Collaboration is
jointly owned by Cocrystal and Merck. Upon completion and termination of the Collaboration in December 2023, our preclinical development
assets property that was licensed under the Collaboration was returned to us where we continue preclinical development activities to
further our influenza A/B program. We believe our influenza A/B program is material to the future development of a comprehensive influenza
antiviral program.
Norovirus
and Coronavirus Programs
We
developed the novel protease inhibitor CDI-988 as an oral 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 viable antiviral for the treatment of viral gastroenteritis caused by noroviruses and of coronaviruses, including
SARS-CoV-2 and its variants.
Oral
CDI-988 has been 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 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.
In
April 2025 we reported that CDI-988 exhibits broad-spectrum activity against newly circulating GII.17 norovirus strains. The highly conserved
binding mode of CDI-988 was also demonstrated using the Company’s drug discovery platform technology.
In
August 2025, the Company announced Phase 1 results including the higher 1,200 dose, with data indicating that all doses, ranging from
100 mg to 1200 mg, were well tolerated. Specifically, overall treatment-emergent adverse events among CDI-988 subjects were 28% (10/36)
compared with 40% (4/10) among placebo subjects for the SAD cohorts, and 53% (19/36) and 92% (11/12), respectively, for the MAD cohorts.
Headache was the most common adverse event. All subjects in the SAD cohorts and all but one in the MAD cohorts completed the study. No
severe treatment-emergent adverse events, no clinically relevant ECG changes and no clinically significant pathology results were reported
from the CDI-988 Phase 1 single-ascending (SAD) and multiple-ascending (MAD) cohorts.
4
In
September 2025, we announced receipt of a Study May Proceed Letter from the U.S. Food and Drug Administration (“FDA”) to
conduct a Phase 1b challenge study evaluating oral CDI-988 as a prophylaxis and treatment of norovirus. The Phase 1b study is expected
to begin during the first half of 2026.
Therapeutic
Targets
Influenza:
A worldwide public health problem, including the potential for pandemic Avian Flu
Influenza
is a severe respiratory illness, caused in humans 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. 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 societal burden to the U.S. 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 has completed 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 779 million reported cases globally, including more than 7 million deaths, as of
October 2025, according to data reported by the WHO.
5
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. 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, multiple SARS-CoV-2 VOCs (variants of concern) and VOIs (variants of interest) 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.
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) 12 weeks of treatment, Epclusa (sofosbuvir/velpatasvir) 12 weeks of treatment, Zepatier
(elbasvir/grazoprevir) 12 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 viable pan-genotypic inhibitor of NS5B polymerase for the treatment of HCV. The Company completed a randomized,
double-blinded, Phase 1a/b study in healthy volunteers and HCV-infected subjects in Canada in September 2016, with favorable safety results.
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 completed a Phase 2a study in HCV
genotype 1 subjects in the U.S. with final study report 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 and Nine Months Ended September 30, 2025 compared to the Three and Nine Months Ended September 30, 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 September 30, 2025, and 2024 were $954,000 and $3,242,000,
respectively. The decrease of $2,288,000 was primarily due to our Influenza CC-42344 product candidate entering into Phase 2a
clinical trial in 2024 and our norovirus and coronavirus candidate CDI-988 entering into a Phase 1 clinical trial in
2024.
Total
research and development expenses for the nine months ended September 30, 2025 and 2024 were $3,436,000 and $10,500,000,
respectively. The decrease of $7,064,000 was primarily due to a reduction of ongoing clinical trial expense in 2025 as the higher
expense portion of these trials were winding down and reductions in employee related expenses.
For the Nine Months Ended
September 30,
2025
2024
Influenza Program
$ 874
$ 6,160
Norovirus and Coronavirus Programs
1,519
2,335
Other discoveries
291
367
Total External cost
2,684
8,862
Indirect allocations:
Salaries, Stock based compensation and other employee expenses
699
1,547
Depreciation and other cost
53
91
Total R&D expense
$ 3,436
$ 10,500
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, 2025, and 2024 were $1,135,000 and $1,800,000, respectively. The
decrease of $665,000 was primarily due to reductions in compensation expense.
7
General
and administrative expenses for the nine months ended September 30, 2025 and 2024 were $3,102,000 and $4,148,000, respectively. The decrease
of $1,046,000 was primarily due to compensation expense reduction, legal and other general and administrative costs.
For
the Nine Months Ended
September
30,
2025
2024
Salaries
and Wages
$
686
$
1,500
Professional/outside
services
424
546
Legal
Consultants
469
493
Rental
Expense
521
499
Investor
and Public relations
259
327
Business
Insurance
185
224
Public
Company expenses
162
233
Travel
and other Expense
396
326
Total
G&A expense
$
3,102
$
4,148
Interest
Income, Net
Interest
income for the three months ended September 30, 2025 and 2024 was $22,000 and $111,000, respectively, and for the nine months
ended September 30, 2025 and 2024 was $87,000 and $482,000, respectively. The interest income was primarily earned on cash held in interest
bearing bank accounts.
Foreign
Exchange Loss
In
2022, the Company established a wholly owned subsidiary in Australia, making it subject to foreign exchange rate fluctuations. There
was a foreign exchange gain during the nine months ended September 30, 2025 of $46,000 and a foreign exchange loss during the nine months
ended September 30, 2024 $72,000.
Income
Taxes
No
income tax benefit or expense was recognized for the three and nine months ended September 30, 2025 and 2024. The Company’s effective
income tax rate was 0.00% for the three and nine months ended September 30, 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 and nine months ended September 30, 2025 was $ 2,049,000 and $6,405,000, respectively,
compared with a net loss for the three and nine months ended September 30, 2024 of $4,939,000 and $14,238,000, respectively, as a result
of developments related to our expenses described above.
Liquidity
and Capital Resources
Net
cash used in operating activities was $6,456,000 for the nine months ended September 30, 2025 compared with net cash used in operating
activities of $13,325,000 for the same period in 2024. This decrease was primarily due to reduced period expenses related to our clinical
trials.
We
used $12,000 net cash for investing activities during the nine months ended September 30, 2025 compared with $8,000 net cash used for
the same period in 2024. For the nine months ended September 30, 2025 the level of investments increased compared with September 30,
2024 due to comparative increase in purchases of laboratory equipment in 2025.
Net
cash provided by financing activities totaled $4,337,000 for the nine months ended September 30, 2025 compared with net cash provided
by financing activities of $0 for the same period in 2024.
The
Company has not yet established an ongoing source of revenue sufficient to cover its operating costs. The Company had $7,729,000
unrestricted cash on September 30, 2025. We expect that our reported cash balance is not 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. As a result, management has concluded that there is substantial doubt about the Company’s ability to continue
as a going concern. The accompanying consolidated financial statements do not include any adjustments relating to the recoverability and
classification of recorded assets, or the amounts and classification of liabilities that might be necessary in the event the company cannot
continue as a going concern. The Company’s independent registered public accounting firm, in its report on the Company’s consolidated
financial statements for the year ended December 31, 2024, has also expressed substantial doubt about the Company’s ability to continue
as a going concern.
8
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. The Company sold 85,076 shares at an average price of $1.88 under the ATM agreement
during the three and nine months ended September 30, 2025. As of the date of this report, the Company has sold a total 1,200,152 shares
of its common stock for total net proceeds of approximately $2,380,000 pursuant to the ATM Agreement. On September 12, 2025, the Company and Wainwright agreed to terminate the sales of shares under the ATM Agreement
and the Company filed a prospectus supplement with the SEC to that effect. As a result of this, the at-the-market offering under the ATM
Agreement is no longer ongoing as of September 12, 2025, and the Company will not make any sales of common stock pursuant to the ATM Agreement
unless and until a new prospectus supplement is filed with the SEC; however, the ATM Agreement remains in full force and effect.
On September 12, 2025, the Company, entered into a securities purchase
agreement with certain accredited investors, pursuant to which the Company sold to the investors (i) in a registered direct offering,
an aggregate of 2,764,710 shares of the Company’s common stock, at a price of $1.70 per share (and (ii) in a concurrent private
placement, warrants to purchase up to an aggregate of 5,529,420 shares of common stock (“the Investor Warrants”), at an initial
exercise price of $1.50 per share. The Investor Warrants are exercisable upon issuance and will expire on September 27, 2027. Wainwright
acted as the Company’s placement agent in connection with offering. The Company paid Wainwright consideration consisting of (i)
a cash fee equal to 7.0% of the aggregate gross proceeds in the offering, (ii) a management fee equal to 1.0% of the aggregate gross proceeds
in the offering, (iii) reimbursement of certain expenses and (iv) warrants to acquire up to an aggregate of 207,353 shares of common stock
(the “Placement Agent Warrants”). The Placement Agent Warrants are similar to the Investor Warrants, except that the initial
exercise price of the Placement Agent Warrants is $2.125 per share.
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 clinical drug candidates,
the progress and expected or potential timelines of achieving certain value driving milestones in our programs, 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.
9
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 our need for additional capital
to fund our ongoing operations and our ability to obtain such capital on favorable terms or at all, the risks arising from inflation,
central bank interest rates, the deterioration of the job market in the
United States, the possibility of a recession and the economic impact of such events and 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 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, the results of the studies for CC-42344
and CDI-988 and any future preclinical and clinical trials we or our strategic partners undertake including any adverse findings or delays,
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 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.
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 September 30, 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 September 30, 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.
10
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-Q for the year ended September 30, 2025.
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 nine months ended September 30, 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.
11
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 – reverse stock split
8-K
10/3/22
3.1
3.1(b)
Certificate of Amendment to Certificate of Incorporation – reduce number of authorized shares
8-K
6/28/24
3.1
3.2
Amended and Restated Bylaws
8-K
2/19/21
3.1
3.2(a)
Amendment No. 1 to Amended and Restated Bylaws
8-K
6/18/25
3.1
4.1
Form of Investor Warrant
8-K
9/15/25
4.1
4.2
Form of Placement Agent Warrant
8-K
9/15/25
4.2
10.1
2025 Equity Incentive Plan
8-K
4/8/25
10.1
10.2
Form of Securities Purchase Agreement
8-K
9/15/25
10.1
10.3
Form of Securities Purchase Agreement
8-K
10/30/25
10.1
31.1
Certification of Principal Executive Officer (302)
Filed
31.2
Certification of Principal Executive Officer (302)
Filed
31.3
Certification of Principal Financial Officer (302)
Filed
32.1
Certification of Principal Executive and Principal Financial Officer (906)
Furnished*
101.INS
Inline
XBRL Instance Document
Filed
101.SCH
Inline
XBRL Taxonomy Extension Schema Document
Filed
101.CAL
Inline
XBRL Taxonomy Extension Calculation Linkbase Document
Filed
101.DEF
Inline
XBRL Taxonomy Extension Definition Linkbase Document
Filed
101.LAB
Inline
XBRL Taxonomy Extension Label Linkbase Document
Filed
101.PRE
Inline
XBRL Taxonomy Extension Presentation Linkbase Document
Filed
104
Cover
Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
Filed
*
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.
12
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 14, 2025
By:
/s/
Sam Lee
Sam
Lee
President
and Co-Chief Executive Officer
(Principal
Executive Officer)
Dated:
November 14, 2025
By:
/s/
James Martin
James
Martin
Chief
Financial Officer and Co-Chief
Executive
Officer
(Principal
Executive Officer and Principal Financial Officer)
13
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.