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, 2026
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 during the preceding 12 months (or for such shorter period that the registrant was required to submit and post
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, 2026, the number of outstanding shares of the registrant’s common stock, par value $ 0.001 per share, was approximately
13,787,453 .
COCRYSTAL
PHARMA, INC.
FORM
10-Q FOR THE QUARTER ENDED MARCH 31, 2026
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
13
2
Part
I – FINANCIAL INFORMATION
COCRYSTAL
PHARMA, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands, except per share data)
March
31, 2026
December
31, 2025
(unaudited)
Assets
Current assets:
Cash
$ 4,685
$ 7,025
Restricted cash
75
75
Grant receivable
70
-
Tax credit receivable
691
706
Prepaid
expenses and other current assets
418
328
Total current assets
5,939
8,134
Property and equipment, net
81
93
Deposits
95
95
Operating lease right-of-use
assets, net (including $ 89 and $ 152 to related party)
1,311
1,390
Total assets
$ 7,426
$ 9,712
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued
expenses
$ 1,886
$ 1,876
Current
maturities of operating lease liabilities (including $ 58 and $ 49 to related party)
343
334
Total current liabilities
2,229
2,210
Long-term liabilities:
Operating
lease liabilities (including $ 32 and $ 104 to related party)
1,081
1,171
Total long-term liabilities
1,081
1,171
Total liabilities
3,310
3,381
Commitments and contingencies
-
-
Stockholders’ equity:
Common stock, $ 0.001 a par value: 100,000 shares authorized as of March
31, 2026 and December 31, 2025; 13,787 and 13,784 shares issued and outstanding as of March 31, 2026 and December 31, 2025
13
13
Additional paid-in capital
348,651
348,567
Accumulated deficit
( 344,548 )
( 342,249 )
Total stockholders’
equity
4,116
6,331
Total liabilities and
stockholders’ equity
$ 7,426
$ 9,712
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)
2026
2025
Three
months ended March 31,
2026
2025
Revenues and grant income:
Grant
income
225
-
Operating expenses:
Research and development
1,371
1,360
General
and administrative
1,210
981
Total operating expenses
2,581
2,341
Loss from operations
( 2,356 )
( 2,341 )
Other income:
Interest income, net
22
37
Foreign
exchange gain, net
35
3
Total
other income, net
57
40
Net loss
$ ( 2,299 )
$ ( 2,301 )
Net loss per common
share, basic and diluted
$ ( 0.17 )
$ ( 0.23 )
Weighted average number of common shares,
basic and diluted
13,786
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, 2026 and 2025
(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, 2025
13,784
$ 13
$ 348,567
$ ( 342,249 )
$ 6,331
Stock-based compensation
-
-
84
84
Shares issued from RSU Award
3
-
-
-
-
Net loss
-
-
-
( 2,299 )
( 2,299 )
Balance as of March 31, 2026
13,787
$ 13
$ 348,651
$ ( 344,548 )
$ 4,116
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
Balance
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
Balance
10,174
$ 10
$ 343,013
$ ( 335,719 )
$ 7,304
See
accompanying notes to condensed consolidated financial statements.
F- 3
COCRYSTAL
PHARMA, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in
thousands)
2026
2025
Three
months ended March 31,
2026
2025
Operating activities:
Net loss
$ ( 2,299 )
$ ( 2,301 )
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation and amortization
expense
12
25
Stock-based compensation
84
82
Decrease right of use assets
79
74
Changes in operating assets
and liabilities:
Grant receivable
( 70 )
-
Prepaid expenses and other
current assets
( 90 )
45
Tax credit receivable
15
( 229 )
Deposits
-
( 57 )
Accounts payable and accrued
expenses
10
( 505 )
Operating lease liabilities
( 81 )
( 73 )
Net cash used in operating
activities
( 2,340 )
( 2,939 )
Net decrease in cash and restricted cash
( 2,340 )
( 2,939 )
Cash and restricted cash
at beginning of period
7,100
9,935
Cash and restricted
cash at end of period
$ 4,760
$ 6,996
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, 2026 AND 2025
(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, 2026, the Company recorded a net loss of approximately $ 2,299,000 and used approximately $ 2,340,000 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, 2025 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, 2026, the Company had cash and restricted cash of approximately $ 4,760,000 . 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 develop, obtain approval and commercialize antiviral drug candidates, including access potential markets, secure financing,
develop a customer base, and to attract, retain and motivate qualified personnel, and develop strategic alliances. Through March 31,
2026, the Company has primarily funded its operations through equity offerings and limited revenue.
F- 5
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 unaudited
and 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,
2025 filed on March 31, 2026 (“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- 6
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, 2026 and December 31, 2025, our primary operating accounts held approximately $ 4,685,000 and $ 7,025,000 ,
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, 2025 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- 7
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, 2026 and December 31, 2025, the carrying amounts of financial assets and liabilities, such as cash, grant receivable, 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 March 31, 2026, the balance of Refundable Tax Credits was approximately $ 691,000 .
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- 8
As
of March 31, 2026, 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, 2026. 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, 2025 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.
Grant
Income
The
Company accounts for government grant funding by analogy to ASC 958-605 because U.S. GAAP does not contain specific guidance for business
entities receiving government grants.
Grant
income is recognized as the Company incurs qualifying research and development expenditures and satisfies the conditions associated with
the grant arrangement.
In
October 2025, the Company announced that it had received a $ 500,000 Small Business Innovation Research (“SBIR”) Phase I award
(the “Award”) from the National Institutes of Health (“NIH”) and the National Institute of Allergy and Infectious
Diseases (“NIAID”). The Award supports the Company’s development of a novel oral broad-spectrum antiviral candidate
for the treatment of influenza A and B infections. The Award is subject to the terms and provisions of Contract No. 75N93025C00038 entered
into with NIAID, covering a performance period from September 2025 through September 2026.
During
the three months ended March 31, 2026, the Company recognized grant income of $ 225,000 under the Award related to qualifying expenditures
incurred during the period. Of the total grant income recognized, $ 70,000 remained outstanding as of March 31, 2026 and was recorded
as a grant receivable in the accompanying balance sheet. The grant receivable was subsequently collected in April 2026.
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
2026
2025
March
31,
2026
2025
Outstanding options to purchase
common stock
838
549
Warrants to purchase common stock
7,223
-
Unvested restricted stock
units
77
155
Total
8,138
704
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- 9
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 March 31, 2026, and December 31, 2025, property and equipment consist of (table in thousands):
Schedule of Property and Equipment
March
31, 2026
December
31, 2025
Lab equipment (excluding equipment
under finance leases)
$ 1,777
$ 1,777
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
2,094
2,094
Less: accumulated depreciation
and amortization
( 2,013 )
( 2,001 )
Property and equipment,
net
$ 81
$ 93
Total
depreciation and amortization expense were approximately $ 12,000 and $ 25,000 for the three months ended March 31, 2026 and 2025, 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, 2026
December
31, 2025
Accounts payable
$ 1,371
$ 890
Accrued compensation
101
85
Accrued other expenses
414
901
Total accounts payable
and accrued expenses
$ 1,886
$ 1,876
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 and Warrants
As
of March 31, 2026, the Company has authorized 100,000,000 shares of common stock, $ 0.001 par value per share. The Company had 13,787,000
and 13,784,000 shares issued and outstanding as of March 31, 2026 and December 31, 2025.
The
holders of common stock are entitled to one vote for each share of common stock held.
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 Warrants Activity
Total
Options
Outstanding
Weighted
Average
Exercise
Price
Aggregate
Intrinsic
Value
Balance at December 31, 2025
7,222,821
$ 1.46
$ -
Granted
-
-
-
Exercised
-
-
-
Forfeited
-
-
-
Outstanding at March 31, 2026
7,222,821
$ 1.46
$ -
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, 2026, no shares remained available
for future grants under the 2015 Plan. The 2015 Plan expired on June 29, 2025.
F- 10
On
April 2, 2025, the Board of Directors of the Company approved and adopted an Equity Incentive Plan (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.
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.
As
of March 31, 2026, 1,893,940 shares remained available for future grants under the 2025 Plan.
Common
Stock Reserved for Future Issuance
The
following table presents information concerning common stock available for future issuance (in thousands) as of March 31, 2026:
Schedule of Common Stock Available for Future Issuance
Shares
Available
for Grant
Stock options issued and outstanding
838
Restricted stock units issued and outstanding
221
Shares authorized for future option grants
1,894
Warrants outstanding
7,223
Balance at March 31, 2026
$ 10,176
Total
$ 10,176
Stock
Options
The
following table summarizes stock option transactions for the 2015 and 2025 Plan, collectively, for the three months ended March 31, 2026
(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, 2025
537
$ 8.91
$ -
Exercised
-
-
-
Granted
319
1.1
-
Cancelled
( 18 )
1.24
-
Balance at March 31, 2026
838
$ 6.10
$ -
In
January 2026, the Compensation Committee of the Company’s Board of Directors granted a total of 318,966 stock options
with a fair value of $ 299,000 effective as of January 9, 2026. The Company granted stock options to directors, executives, employees,
and consultants. The options are ten-year incentive stock options exercisable at $ 1.10 per share and vesting as follows: one-half
vest on the one-year anniversary of the grant date and the remainder vest in eight equal quarterly instalments commencing on March 31,
2027.
The
fair value of share option award is estimated using the Black-Scholes option pricing method based on the following weighted-average assumptions:
Schedule
of Fair Value of Share Option Award
Three months ended March 31,
2026
2025
Risk-Free interest rate
3.83 %
0.00 %
Expected dividend yield
0.00 %
0.00 %
Expected volatility
106.3
-
Expected term (in years)
5.77
-
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, 2025
97
$ 1.76
$ -
Granted
-
-
-
Forfeited
( 6 )
-
-
Vested
( 15 )
-
-
Unvested and expected
to vest at March 31, 2026
76
$ 1.76
$ -
F- 11
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, 2026 and 2025, equity-based compensation expense recorded was approximately $ 84,000
and $ 82,000 , respectively.
As
of March 31, 2026, there was approximately $ 279,000 of total unrecognized compensation expense related to non-vested stock options that
is expected to be recognized over a weighted average period of 1.3 years. For options granted and outstanding, there were 838,351 options
outstanding which were fully vested or expected to vest, with an aggregate intrinsic value of $ 0.00 , a weighted average exercise price
of $ 6.10 and weighted average remaining contractual term of 7.14 years at March 31, 2026. For vested and exercisable options, outstanding
shares totaled 823,840 , with an aggregate intrinsic value of $ 0.00 . These options had a weighted average exercise price of $ 9.07 per
share and a weighted-average remaining contractual term of 5.61 years at March 31, 2026.
The
aggregate intrinsic value of outstanding and exercisable options at March 31, 2026 was calculated based on the closing price of the Company’s
common stock as reported on The Nasdaq Capital Market on March 31, 2026 of $ 1.01 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, 2026
(table in thousands):
Schedule of Maturities of Operating Lease Liabilities
2026 (excluding the three months
ended March 31, 2026)
$ 315
2027
415
2028
376
2029
249
2030 and thereafter
264
Total operating lease payments
1,619
Less: present value
discount
( 195 )
Total operating lease
liabilities
$ 1,424
F- 12
As
of March 31, 2026, the total operating lease liability of $ 343 is classified as a current operating lease liability.
In
April 2023, the Company renewed its lease for the unit 100 at the Bothell, Washington facility (“Bothell 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.
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.
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, 2026 and 2025, approximately $ 44,000 and $ 39,000 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- 13
For
the three months ended March 31, 2026 and 2025, operating lease expense, including short-term leases, finance leases and CAM charges,
totaled approximately $ 102,000 and $ 103,000 , respectively, of which $ 16,000 and $ 16,000 for each period was to a related party.
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 for
each of the three months ended March 31, 2026 and 2025 respectively.
9.
Segment Information
The
Company operates and manages its business as one 1 reportable and operating segment dedicated to the research and development of the 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
2026
2025
Three
months ended March 31,
2026
2025
Revenue
$ 225
$ -
Less:
Research and development
1,042
1,027
Salaries and personnel costs
481
544
Insurance
57
62
Stock-based compensation
84
82
Operating expenses
917
625
Other income
( 57 )
( 39 )
Net
loss
$ 2,299
$ 2,301
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 in efforts 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 caused by RNA viruses including norovirus, influenza virus, coronaviruses
(including SARS-CoV-2 and MERS-COV), respiratory virus infections 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, 2026 and more recently the Company continued to focus its research and development efforts primarily
in three areas of norovirus, influenza and coronavirus.
Norovirus
Program
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 the only oral pan-viral antiviral in development for the treatment and prevention of viral gastroenteritis
caused by noroviruses, and coronaviruses, including SARS-CoV-2 and its variants.
Oral
CDI-988, the first oral direct-acting protease inhibitor, was 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 conducted in
Australia.
3
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 (“SAEs”) 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.
Topline Phase 1 study safety and tolerability SAD results and testing of 800 mg for 10 consecutive days were reported in January 2025
indicating favorable safety and tolerability results. We also announced that an additional cohort with a higher dose of 1,200 mg and
a shorter treatment duration of five consecutive days would be conducted to further assess CDI-988’s safety, tolerability and pharmacokinetics.
In August 2025 we presented favorable safety and tolerability Phase 1 data from all CDI-988 doses, including the high-dose 1200 mg cohort,
at the 2025 Military Health System Research Symposium (MHSRS).
In
September 2025 we received a Study May Proceed Letter from the FDA to conduct a Phase 1b challenge study in the U.S. evaluating CDI-988
as a norovirus preventive and treatment. In December 2025, we received Institutional Review Board approval from Emory University School
of Medicine, the clinical study site for the Phase 1b trial, and announced that subject screening for the study was underway. In February
2026, we announced commencement of the Phase 1b challenge study at Emory University School of Medicine. The study’s primary efficacy
endpoint is to assess the reduction in incidence of clinical symptoms, while the secondary efficacy endpoint focuses on the reduction
in viral shedding and disease severity. The study will also assess the safety and pharmacokinetic profile of CDI-988.
We
recently announced that the FDA has granted Fast Track designation to CDI-988. The FDA Fast Track designation aims to facilitate the
development and accelerate the review process for drugs that treat serious conditions and address unmet medical needs and allows for
a rolling review of a new drug application (NDA) and might help qualify a product for priority review at the time of NDA submission.
In
March 2026, we enrolled the first subjects in our Phase 1b norovirus challenge study to evaluate CDI-988 as both a preventative and treatment
for norovirus infections, with the initial cohort evaluating the infectivity rate of the GII.2 (Snow Mountain Virus) challenge inoculum,
and subsequent cohorts to be orally administered CDI-988 or placebo.
Influenza
Programs
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 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.
In
December 2023 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. While in the Phase 2a study CC-42344 demonstrated favorable
safety and tolerability profile and no serious adverse events (“SAEs”) or drug-related discontinuations by study participants,
due to unexpectedly low influenza infection among study participants, management determined that the low infectivity obtained in this
study hindered antiviral data analysis. A dispute has arisen with the United Kingdom clinical research organization (the “CRO”)
that performed the Phase 2a study. The Company contends that the CRO breached its agreement in a number of respects and is requesting
that the CRO refund the $6,309,000 it was paid or redo the study. The CRO has implicitly denied liability and is seeking to recover an
additional approximately $600,000 from the Company. As of the date of this Report, it appears that the Company will seek to arbitrate
the dispute as required under the agreement with the CRO and more recently has filed a demand letter reserving all of our rights and
has initiated arbitration. See the risk factor entitled “We face significant risks and uncertainties surrounding our Influenza
A program following an initial Phase 2a study which failed to yield scientifically viable results relating to the product candidate’s
efficacy” beginning on page 14 of our Annual Report on Form 10-K for the year ended December 31, 2025. Subject to resolution of
this issue or our raising capital to conduct another study, we plan to continue development of oral CC-42344 as a treatment for pandemic
and seasonal influenza A.
4
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. On October 27, 2025, the Company announced it 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.
Coronavirus
Program
As
repeated from our norovirus program above, 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.
Oral
CDI-988 was 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 conducted in Australia.
We
continue to evaluate CDI-988 for additional program development.
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 virus. 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 16% 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.
5
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 7.1 million deaths, as
of April 2026, 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.
6
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.
We
are targeting the viral NS5B polymerase with a non-nucleoside inhibitor (“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. Combining CC-31244 with different classes of approved DAAs has the potential to change the paradigm of treatment for HCV by
shortening the 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. We 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.
We completed a Phase 2a study in HCV genotype 1 subjects in the U.S. in 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. In 2017, we completed the Phase 2a final study report as
filed with the FDA.
We
have been seeking a partner for further clinical development of CC-31244 since completing a Phase 2a study.
Results
of Operations for the Three Months Ended March 31, 2026 compared to the Three Months Ended March 31, 2025
Grant Income
The Company 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.
Grant income is earned by award program progress from
Company services provided. Total grant income for the three months ended March 31, 2026, and 2025 were $225,000 and $0, respectively.
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, 2026, and 2025 were $1,371,000 and $1,360,000, respectively.
7
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, 2026, and 2025 were $1,210,000 and $981,000, respectively. The increase
of $229,000 was predominantly due to an increase in legal and consultant cost partially offset with a decrease of $76,000 on salary and
wages.
Interest
Income, Net
Interest
income for the three months ended March 31, 2026 and 2025 was $22,000 and $37,000, respectively. The interest income was primarily earned
on cash held in interest bearing bank accounts.
Other
Income (Expense)
In
2022, the Company established a wholly owned subsidiary in Australia, making it subject to foreign exchange rate fluctuations. Foreign
exchange gain of $35,000 and $3,000 was recorded for the three months ended March 31, 2026 and 2025, respectively.
Income
Taxes
No
income tax benefit or expense was recognized for the three months ended March 31, 2026 and 2025. The Company’s effective income
tax rate was 0.00% for the three months ended March 31, 2026 and 2025. 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, 2026 was $2,299,000 compared with a net loss of $2,301,000
for the three months ended March 31, 2025, respectively, as a result of developments related to our three months ended March 31, 2026
grant income of $225,000 and expenses as described above.
Liquidity
and Capital Resources
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, 2026, the Company recorded a net loss of approximately $2,299,000 and used approximately $2,340,000 of cash in operating
activities. These factors raise substantial doubt about the Company’s ability to continue as a going concern.
On
March 31, 2026, the Company had cash and restricted cash of approximately $4,760,000. 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, 2025,
has also expressed substantial doubt about the Company’s ability to continue as a going concern.
Net
cash used in operating activities was $2,340,000 for the three months ended March 31, 2026 compared with net cash used in operating activities
of $2,939,000 for the same period in 2025. This decrease was primarily due to decrease in period expenses related to our Influenza A
Phase 2a clinical trial.
The
Company has not yet established an ongoing source of revenue sufficient to cover its operating costs. The Company had $4,685,000 unrestricted
cash on March 31, 2026. 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 for the
remainder of 2026 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.
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.
8
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, 2026.
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.
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 expectations regarding future characteristics of the product candidates
we develop, 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 materially 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 the Middle East 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, 2025. We undertake no obligation to publicly
update or revise any forward-looking statements, whether as the result of new information, future events or otherwise.
9
Critical
Accounting Policies and Estimates
In
our Annual Report on Form 10-K for the year ended December 31, 2025, 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, 2025 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, 2026 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, 2026. 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
As
disclosed in our Annual Report, a dispute has arisen with the United Kingdom clinical research organization (the “CRO”) that
performed the Phase 2a study. The Company contends that the CRO breached its agreement and is requesting that the CRO refund the $6,309,000
it was paid or redo the study. The CRO has implicitly denied liability and is seeking to recover an additional approximately $600,000
from the Company. The Company has initiated arbitration to resolve the dispute as required under the agreement with the CRO. See the
risk factor entitled “We face significant risks and uncertainties surrounding our Influenza A program following an initial Phase
2a study which failed to yield scientifically viable results relating to the product candidate’s efficacy” beginning on page
14 of our Annual Report and the discussion in Item 2 above under “Influenza Programs.” Additionally, 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, 2025 and, .a s of the date of this Report, the Company is not aware of any pending legal proceedings
to which the Company or any of its subsidiaries is a party which, if determined adversely, would have a material effect on its business,
results of operations, cash flows or financial position.
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, 2026, 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
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.
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:
May 15, 2026
By:
/s/
Sam Lee
Sam
Lee
President
and Co-Chief Executive Officer
(Principal
Executive Officer)
Dated:
May 15, 2026
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.