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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 June 30, 2024
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 August 14, 2024, the number of outstanding shares of the registrant’s common stock, par value $0.001 per share, was approximately
10,173,790.
COCRYSTAL
PHARMA, INC.
FORM
10-Q FOR THE QUARTER ENDED JUNE 30, 2024
INDEX
Part
I – FINANCIAL INFORMATION
COCRYSTAL
PHARMA, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands, except per share data)
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
(unaudited) | | |
| |
Assets | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash | |
$ | 18,143 | | |
$ | 26,353 | |
Restricted cash | |
| 75 | | |
| 75 | |
Tax credit receivable | |
| 1,077 | | |
| 890 | |
Prepaid expenses and other current assets | |
| 365 | | |
| 1,773 | |
Total current assets | |
| 19,660 | | |
| 29,091 | |
Property and equipment, net | |
| 211 | | |
| 271 | |
Deposits | |
| 29 | | |
| 46 | |
Operating lease right-of-use assets, net (including $11 and $42 to related party) | |
| 1,673 | | |
| 1,851 | |
Total assets | |
$ | 21,573 | | |
$ | 31,259 | |
| |
| | | |
| | |
Liabilities and stockholders’ equity | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable and accrued expenses | |
$ | 2,403 | | |
$ | 3,022 | |
Current maturities of operating lease liabilities (including $10 and $42 to related party) | |
| 251 | | |
| 240 | |
Total current liabilities | |
| 2,654 | | |
| 3,262 | |
Long-term liabilities: | |
| | | |
| | |
| |
| | | |
| | |
Operating lease liabilities (including $0 and $0 to related party) | |
| 1,529 | | |
| 1,613 | |
Total long-term liabilities | |
| 1,529 | | |
| 1,613 | |
Total liabilities | |
| 4,183 | | |
| 4,875 | |
| |
| | | |
| | |
Commitments and contingencies | |
| - | | |
| - | |
| |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Common stock, $0.001 a par value: 100,000 and 150,000 shares authorized as of June 30, 2024, and December 31, 2023; 10,174 shares issued and outstanding as of June 30, 2024 and December 31, 2023 | |
| 10 | | |
| 10 | |
Additional paid-in capital | |
| 342,593 | | |
| 342,288 | |
Accumulated deficit | |
| (325,213 | ) | |
| (315,914 | ) |
Total stockholders’ equity | |
| 17,390 | | |
| 26,384 | |
Total liabilities and stockholders’ equity | |
$ | 21,573 | | |
$ | 31,259 | |
See
accompanying notes to condensed consolidated financial statements.
COCRYSTAL
PHARMA, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in
thousands, except per share data)
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three months ended June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 4,308 | | |
| 2,801 | | |
| 7,258 | | |
| 6,708 | |
General and administrative | |
| 1,140 | | |
| 1,538 | | |
| 2,348 | | |
| 2,742 | |
Total operating expenses | |
| 5,448 | | |
| 4,339 | | |
| 9,606 | | |
| 9,450 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (5,448 | ) | |
| (4,339 | ) | |
| (9,606 | ) | |
| (9,450 | ) |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Interest income, net | |
| 151 | | |
| 140 | | |
| 371 | | |
| 140 | |
Foreign exchange gain (loss) | |
| (46 | ) | |
| 33 | | |
| (64 | ) | |
| (45 | ) |
Total other expense, net | |
| 105 | | |
| 173 | | |
| 307 | | |
| 95 | |
Net loss | |
$ | (5,343 | ) | |
$ | (4,166 | ) | |
| (9,299 | ) | |
| (9,355 | ) |
Net loss per common share, basic and diluted | |
$ | (0.53 | ) | |
$ | (0.41 | ) | |
| (0.91 | ) | |
| (1.03 | ) |
Weighted average number of common shares outstanding, basic and diluted | |
| 10,174 | | |
| 10,065 | | |
| 10,174 | | |
| 9,109 | |
See
accompanying notes to condensed consolidated financial statements.
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, 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 | |
| |
Common Stock | | |
Additional Paid-in | | |
Accumulated | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balance as of December 31, 2022 | |
| 8,143 | | |
$ | 8 | | |
$ | 337,489 | | |
$ | (297,930 | ) | |
$ | 39,567 | |
Stock-based compensation | |
| - | | |
| - | | |
| 291 | | |
| - | | |
| 291 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (5,189 | ) | |
| (5,189 | ) |
Balance as of March 31, 2023 | |
| 8,143 | | |
$ | 8 | | |
$ | 337,780 | | |
$ | (303,119 | ) | |
$ | 34,669 | |
Balance | |
| 8,143 | | |
$ | 8 | | |
$ | 337,780 | | |
$ | (303,119 | ) | |
$ | 34,669 | |
Stock-based compensation | |
| - | | |
| - | | |
| 179 | | |
| - | | |
| 179 | |
Sale of common stock, net of transaction costs | |
| 2,031 | | |
| 2 | | |
| 3,998 | | |
| - | | |
| 4,000 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (4,166 | ) | |
| (4,166 | ) |
Balance as of June 30, 2023 | |
| 10,174 | | |
$ | 10 | | |
$ | 341,957 | | |
$ | (307,285 | ) | |
$ | 34,682 | |
Balance | |
| 10,174 | | |
$ | 10 | | |
$ | 341,957 | | |
$ | (307,285 | ) | |
$ | 34,682 | |
See
accompanying notes to condensed consolidated financial statements.
COCRYSTAL
PHARMA, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in
thousands)
| |
2024 | | |
2023 | |
| |
Six months ended June 30, | |
| |
2024 | | |
2023 | |
Operating activities: | |
| | | |
| | |
Net loss | |
$ | (9,299 | ) | |
$ | (9,355 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization expense | |
| 68 | | |
| 96 | |
Stock-based compensation | |
| 305 | | |
| 470 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Prepaid expenses and other current assets | |
| 1,408 | | |
| 183 | |
Deposits | |
| 17 | | |
| - | |
Tax credit receivable | |
| (187 | ) | |
| (491 | ) |
Decrease in right of use assets | |
| 178 | | |
| 108 | |
Accounts payable and accrued expenses | |
| (619 | ) | |
| 445 | |
Operating lease liabilities | |
| (73 | ) | |
| (115 | ) |
Net cash used in operating activities | |
| (8,202 | ) | |
| (8,659 | ) |
| |
| | | |
| | |
Investing activities: | |
| | | |
| | |
Purchases of property and equipment | |
| (8 | ) | |
| (59 | ) |
Net cash used in investing activities | |
| (8 | ) | |
| (59 | ) |
| |
| | | |
| | |
Financing activities: | |
| | | |
| | |
Payments on finance lease liabilities | |
| - | | |
| (7 | ) |
Proceeds from sale of common stock, net of transaction costs | |
| - | | |
| 4,000 | |
Net cash used in financing activities | |
| - | | |
| 3,993 | |
| |
| | | |
| | |
Net decrease in cash and restricted cash | |
| (8,210 | ) | |
| (4,725 | ) |
Cash and restricted cash at beginning of period | |
| 26,428 | | |
| 37,219 | |
Cash and restricted cash at end of period | |
$ | 18,218 | | |
$ | 32,494 | |
See
accompanying notes to condensed consolidated financial statements.
COCRYSTAL
PHARMA, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE SIX MONTHS ENDED JUNE 30, 2024 AND 2023
(unaudited)
1.
Organization and Business
Cocrystal
Pharma, Inc. (“we”, the “Company” or “Cocrystal”), a clinical stage biopharmaceutical company incorporated
in Delaware, has been developing novel technologies and approaches to create first-in-class or best-in-class antiviral drug candidates.
Our focus is to pursue the development and commercialization of broad-spectrum antiviral drug candidates that will transform the treatment
and prophylaxis of viral diseases in humans. By concentrating our research and development efforts on viral replication inhibitors, we
plan to leverage our infrastructure and expertise in these areas.
The
Company’s activities since inception have principally consisted of acquiring product and technology rights, raising capital, and
performing research and development. Successful completion of the Company’s development programs, obtaining regulatory approvals
of its products and, ultimately, the attainment of profitable operations is dependent on future events, including, among other things,
its ability to access potential markets, secure financing, develop a customer base, attract, retain and motivate qualified personnel,
and develop strategic alliances. Through June 30, 2024, the Company has primarily funded its operations through equity offerings.
Liquidity
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 six months ended June 30, 2024, the Company recorded a net loss of approximately
$9,299,000 and used approximately $8,202,000 of cash in operating activities.
On June 30, 2024, the Company had cash and cash equivalents
of approximately $18,143,000. We believe that our current resources will be sufficient to fund our operations beyond the next 12 months.
This estimate is based, in part, upon our currently projected expenditures.
The Company’s activities since inception have
principally consisted of acquiring product and technology rights, raising capital, and performing research and development. Successful
completion of the Company’s development programs, obtaining regulatory approvals of its products and, ultimately, the attainment
of profitable operations is dependent on future events, including, among other things, its ability to access potential markets, secure
financing, develop a customer base, attract, retain and motivate qualified personnel, and develop strategic alliances. Through June 30,
2024, the Company has primarily funded its operations through equity offerings.
The Company will need to continue obtaining adequate
capital to fund operating losses until it becomes profitable. The Company can give no assurances that the additional capital it is able
to raise, if any, will be sufficient to meet its needs, or that any such financing will be obtainable on acceptable terms. Our future
cash requirements, and the timing of those requirements, will depend on a number of factors, including economic conditions, the approval
and success of our products in development, the continued progress of research and development of our product candidates, the timing and
outcome of clinical trials and regulatory approvals, the costs involved in preparing, filing, prosecuting, maintaining, defending, and
enforcing patent claims and other intellectual property rights, the status of competitive products, the availability of financing, our
success in developing markets for our product candidates and legal proceedings that may arise. We have historically not generated sustained
positive cash flow and if we are not able to secure additional funding when needed, we may have to delay, reduce the scope of, or eliminate
one or more of our clinical trials or research and development programs. If the Company is unable to obtain adequate capital, it could
be forced to cease operations or substantially curtail its drug development activities. The Company expects to continue incurring substantial
operating losses and negative cash flows from operations over the next several years during its pre-clinical and clinical development
phases.
2.
Basis of Presentation and Significant Accounting Policies
Basis
of Presentation
The
accompanying condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting
principles (“U.S. GAAP”) for interim financial information, the instructions to Form 10-Q and Article 10 of Regulation S-X
set forth by the Securities and Exchange Commission (“SEC”). They do not include all of the information and notes required
by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals)
considered necessary for a fair presentation have been included. The results of operations for the interim periods presented are not
necessarily indicative of the results of operations for the entire fiscal year. For further information, refer to the consolidated financial
statements and footnotes thereto included in the Company’s annual report on Form 10-K for the year ended December 31, 2023 filed
on March 28, 2024 (“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 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 June 30, 2024 and December 31, 2023, our primary operating accounts held approximately $7,536,000 and $16,322,000,
respectively, and our collateral account balance was $75,000 and $75,000 at a different institution. The Company has not experienced
any losses in such accounts and believes it is not exposed to significant risks thereof.
Foreign
Currency Transactions
The
Company and its subsidiaries use the U.S. dollar as functional currency. Foreign currency transactions are initially measured and recorded
in the functional currency using the exchange rate on the date of the transaction. Foreign exchange gains and losses arising from settlement
of foreign currency transactions are recognized in profit and loss.
Cocrystal
Australia maintains its records in Australian dollars. The monetary assets and liabilities of Cocrystal Australia are remeasured into
the functional currency using the closing rate at the end of every reporting period. All nonmonetary assets and liabilities and related
profit and loss accounts are remeasured into the functional currency using the historical exchange rates. Profit and loss accounts, other
than those that are remeasured using the historical exchange rates, are remeasured into the functional currency using the average exchange
rate for the period. Foreign exchange gains and losses arising from the remeasurement into the functional currency is recognized in profit
and loss.
Fair
Value Measurements
FASB
Accounting Standards Codification (“ASC”) 820 defines fair value, establishes a framework for measuring fair value under
U.S. GAAP and enhances disclosures about fair value measurements. Fair value is defined under ASC 820 as the exchange price that would
be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or
liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value
under ASC 820 must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes a fair value
hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used
to measure fair value which are the following:
|
Level
1 — quoted prices in active markets for identical assets or liabilities. |
|
|
|
Level
2 — other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement
date. |
|
|
|
Level
3 — significant unobservable inputs that reflect management’s best estimate of what market participants would use to
price the assets or liabilities at the measurement date. |
At
June 30, 2024 and December 31, 2023, the carrying amounts of financial assets and liabilities, such as cash, other current 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, 2023, balance of Refundable Tax Credits was approximately $786,000. The Company estimated
and accrued Refundable Tax Credits for the six months ended June 30, 2024 of approximately $264,000, resulting in a total balance of
Refundable Tax Credits receivable of approximately $1,050,000 as of the period then ended.
Income
Taxes
The
Company accounts for income taxes under the asset and liability method. Under this method, deferred tax assets and liabilities are determined
based on differences between financial reporting and tax bases of assets and liabilities and are measured using enacted tax rates and
laws that are expected to be in effect when the differences are expected to be recovered or settled. Realization of deferred tax assets
is dependent upon future taxable income. A valuation allowance is recognized if it is more likely than not that some portion or all of
a deferred tax asset will not be realized based on the weight of available evidence, including expected future earnings. The Company
recognizes an uncertain tax position in its financial statements when it concludes that a tax position is more likely than not to be
sustained upon examination based solely on its technical merits. Only after a tax position passes the first step of recognition will
measurement be required. Under the measurement step, the tax benefit is measured as the largest amount of benefit that is more likely
than not to be realized upon effective settlement. This is determined on a cumulative probability basis. The full impact of any change
in recognition or measurement is reflected in the period in which such change occurs. The Company elects to accrue any interest or penalties
related to income taxes as part of its income tax expense.
As
of June 30, 2024, the Company assessed its income tax expense based on its projected future taxable income for the year ending December
31, 2024 and therefore recorded no amount for income tax expense for the six months ended June 30, 2024. 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, 2023 for more information.
Stock-Based
Compensation
The
Company recognizes compensation expense using a fair value-based method for costs related to stock-based payments, including stock options.
The fair value of options awarded to employees is measured on the date of grant using the Black-Scholes option pricing model and is recognized
as expense over the requisite service period on a straight-line basis.
Use
of the Black-Scholes option pricing model requires the input of subjective assumptions including expected volatility, expected term,
and a risk-free interest rate. The Company estimates volatility using a blend of its own historical stock price volatility as well as
that of market comparable entities since the Company’s common stock has limited trading history and limited observable volatility
of its own. The expected term of the options is estimated by using the SEC Staff Bulletin No. 107’s Simplified Method for Estimate
Expected Term. The risk-free interest rate is estimated using comparable published federal funds rates.
Common
Stock Purchase Warrants and Other Derivative Financial Instruments
We
classify as equity any contracts that require physical settlement or net-share settlement or provide us a choice of net-cash settlement
or settlement in our own shares (physical settlement or net-share settlement) provided that such contracts are indexed to our own stock
as defined in ASC 815-40, Contracts in Entity’s Own Equity. We classify as assets or liabilities any contracts that require
net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside our control)
or give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement). We assess
classification of our common stock purchase warrants and other freestanding derivatives at each reporting date to determine whether a
change in classification between assets and liabilities is required.
Net
Income (Loss) per Share
The
Company accounts for and discloses net income (loss) per common share in accordance with FASB ASC Topic 260, Earnings Per Share.
Basic income (loss) per common share is computed by dividing income (loss) attributable to common stockholders by the weighted average
number of common shares outstanding. Diluted net income (loss) per common share is computed by dividing net income (loss) attributable
to common stockholders by the weighted average number of common shares that would have been outstanding during the period assuming the
issuance of common stock for all potential dilutive common shares outstanding. Potential common shares consist of shares issuable upon
the exercise of stock options and warrants and the conversion of convertible notes payable.
The
following table sets forth the number of potential common shares excluded from the calculations of net loss per diluted share because
their inclusion would be anti-dilutive (in thousands):
Schedule of Anti-dilutive Securities Excluded from Calculations of Net Loss Per Share
| |
2024 | | |
2023 | |
| |
June 30, | |
| |
2024 | | |
2023 | |
Outstanding options to purchase common stock | |
| 555 | | |
| 350 | |
Warrants to purchase common stock | |
| - | | |
| 13 | |
Total | |
| 555 | | |
| 363 | |
Recent
Accounting Pronouncements
Authoritative
guidance issued by the FASB (including technical corrections to the ASC), the American Institute of Certified Public Accountants, and
the SEC did not, or are not expected to, have a material impact on the Company’s consolidated financial statements and related
disclosures.
3.
Property and Equipment
Property
and equipment are recorded at cost and depreciated over the estimated useful lives of the underlying assets (three to five years) using
the straight-line method. As of June 30, 2024, and December 31, 2023, property and equipment consists of (table in thousands):
Schedule of Property and Equipment
| |
June 30, 2024 | | |
December 31, 2023 | |
Lab equipment (excluding equipment under finance leases) | |
$ | 1,765 | | |
$ | 1,757 | |
Finance lease right-of-use lab equipment obtained in exchange for finance lease liabilities, net | |
| 162 | | |
| 162 | |
Computer and office equipment | |
| 155 | | |
| 155 | |
Total property and equipment | |
| 2,082 | | |
| 2,074 | |
Less: accumulated depreciation and amortization | |
| (1,871 | ) | |
| (1,803 | ) |
Property and equipment, net | |
$ | 211 | | |
$ | 271 | |
Total
depreciation and amortization expense were approximately $68,000 and $96,000 for the six months ended June 30, 2024 and 2023, which includes
amortization expense of $0 and $7,164 for the six months ended June 30, 2024 and 2023, respectively, related to assets under finance
lease. For additional finance leases information, refer to Note 9 – Commitments and Contingencies.
4.
Accounts Payable and Accrued Expenses
Accounts
payable and accrued expenses consisted of the following (in thousands) as of:
Schedule of Accounts Payable and Accrued Expenses
| |
June 30, 2024 | | |
December 31, 2023 | |
Accounts payable | |
$ | 1,743 | | |
$ | 1,222 | |
Accrued compensation | |
| 156 | | |
| 109 | |
Accrued other expenses | |
| 504 | | |
| 1,691 | |
Total accounts payable and accrued expenses | |
$ | 2,403 | | |
$ | 3,022 | |
Accounts
payable and accrued other expenses contain unpaid general and administrative expenses and costs related to research and development that
have been billed and estimated unbilled, respectively, as of period-end.
5.
Common Stock and Preferred Stock
As
of June 30, 2024, 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.
On
June 27, 2024, the Company, following approval of the Company’s stockholders at the 2024 Annual Meeting of Stockholders filed an
amendment to its Certificate of Incorporation with the Secretary of State of the State of Delaware (the “Amendment”) to decrease
the number of shares of authorized capital stock of the Company from 155,000,000 shares of capital stock, consisting of 150,000,000 shares
of common stock and 5,000,000 shares of preferred stock, to 101,000,000 shares of capital stock consisting of 100,000,000 shares of common
stock and 1,000,000 shares of preferred stock. The Amendment became effective on June 27, 2024.
The
Company had 10,174,000 shares of common stock and no shares of preferred stock issued and outstanding as of June 30, 2024, and December
31, 2023.
The
holders of common stock are entitled to one vote for each share of common stock held.
6.
Stock Based Awards
Equity
Incentive Plans
The
Company adopted an equity incentive plan in 2015 (the “2015 Plan”) under which 833,333 shares of common stock have been reserved
for issuance to employees, and non-employee directors and consultants of the Company. Recipients of incentive stock options granted under
the 2015 Plan shall be eligible to purchase shares of the Company’s common stock at an exercise price equal to no less than the
estimated fair market value of such stock on the date of grant. The maximum term of options granted under the 2015 Plan is ten years.
On June 16, 2021, the Company’s stockholders voted to approve an amendment to the 2015 Plan to increase the number of shares of
common stock authorized for issuance under the 2015 Plan from 416,667 to 833,333 shares. As of June 30, 2024, 278,000 shares remain available
for future grants under the 2015 Plan.
The
following table summarizes stock option transactions for the 2015 Plan, collectively, for the six months ended June 30, 2024 (in thousands,
except per share amounts):
Schedule of Stock Option Transactions
| |
Number of Shares Available for Grant | | |
Total Options Outstanding | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
Balance at December 31, 2023 | |
| 275 | | |
| 558 | | |
$ | 10.57 | | |
$ | - | |
Exercised | |
| - | | |
| - | | |
| - | | |
| - | |
Granted | |
| - | | |
| - | | |
| - | | |
| - | |
Expired | |
| 3 | | |
| (3 | ) | |
| 4.90 | | |
| - | |
Balance at June 30, 2024 | |
| 278 | | |
| 555 | | |
$ | 10.40 | | |
$ | - | |
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 six months ended June 30, 2024 and 2023, equity-based compensation expense recorded was approximately
148,000 and $179,000 and $305,000 and $241,000, respectively.
As
of June 30, 2024, there was approximately $402,000 of total unrecognized compensation expense related to non-vested stock options that
is expected to be recognized over a weighted average period of 0.9 years. For options granted and outstanding, there were 555,000 options
outstanding which were fully vested or expected to vest, with an aggregate intrinsic value of $0, a weighted average exercise price of
$10.40 and weighted average remaining contractual term of 7.7 years at June 30, 2024. For vested and exercisable options, outstanding
shares totaled 307,000, with an aggregate intrinsic value of $0. These options had a weighted average exercise price of $16.33 per share
and a weighted-average remaining contractual term of 6.8 years at June 30, 2024.
The
aggregate intrinsic value of outstanding and exercisable options at June 30, 2024 was calculated based on the closing price of the Company’s
common stock as reported on The Nasdaq Capital Market on June 30, 2024 of $2.33 per share less the exercise price of the options. The
aggregate intrinsic value is calculated based on the positive difference between the closing fair market value of the Company’s
common stock and the exercise price of the underlying options.
Common
Stock Reserved for Future Issuance
The
following table presents information concerning common stock available for future issuance (in thousands) as of:
Schedule of Common Stock Reserved for Future Issuance
| |
June 30, 2024 | | |
June 30, 2023 | |
Stock options issued and outstanding | |
| 555 | | |
| 350 | |
Shares authorized for future option grants | |
| 278 | | |
| 484 | |
Warrants outstanding | |
| - | | |
| 13 | |
Total | |
| 833 | | |
| 847 | |
7.
Warrants
The
following is a summary of activity in the number of warrants classified as liabilities outstanding to purchase the Company’s common
stock for the six months ended June 30, 2024 (in thousands):
Schedule
of Warrants Activity
| |
January 2014 Warrants | |
Outstanding, December 31, 2023 | |
| 11 | |
Exercised | |
| - | |
Granted | |
| - | |
Expired | |
| (11 | ) |
Outstanding, June 30, 2024 | |
| - | |
Expiration date: | |
| 1/16/2024 | |
8.
Licenses and Collaborations
Merck
Sharp & Dohme Corp.
On
January 2, 2019, the Company entered into an Exclusive License and Research Collaboration Agreement (the “Collaboration Agreement”)
with Merck Sharp & Dohme LLC (“Merck”) to discover and develop certain proprietary influenza A/B antiviral agents. Under
the terms of the Collaboration Agreement, Merck funded research and development for the program, including clinical development, and
was responsible for worldwide commercialization of any products derived from the collaboration. Under the Collaboration Agreement Cocrystal
was eligible to receive payments related to designated development, regulatory and sales milestones with the potential to earn up to
$156,000,000, as well as royalties on product sales. The Collaboration Agreement provided that Merck may terminate the Collaboration
Agreement at any time prior to the first commercial sale of the first product developed under the Collaboration Agreement, in its sole
discretion, without cause.
On
December 15, 2023, the Company received written notice from Merck of Merck’s election to terminate the Collaboration Agreement.
The termination of the Collaboration Agreement took effect on March 14, 2024. According to Merck’s termination notice, Merck determined
there were no existing conditions to continue the collaboration. The termination resulted from the inability to develop the compounds
to meet a specific aspect of Merck’s program. The pending patent applications on compounds covered by the Collaboration Agreement
and previously filed by Merck on behalf of both companies remain in place.
Kansas
State University Research Foundation
Cocrystal
entered into two License Agreement with Kansas State University Research Foundation (the “Foundation”) on February 18, 2020
to further develop certain proprietary broad-spectrum antiviral compounds for the treatment of norovirus and coronavirus infections.
On
February 28, 2024, the Company provided notice to the Foundation of the Company’s election to terminate the 2020 License Agreements.
The terminations, which were made due to the Company’s determination that further development efforts under the License Agreements
would be futile, took effect on March 29, 2024.
9.
Commitments and Contingencies
Commitments
In
the ordinary course of business, the Company enters into non-cancellable leases to purchase equipment and for its facilities, including
related party leases (see Note 10 – Transactions with Related Parties). Leases are accounted for as operating leases or finance
leases, in accordance with ASC 842, Leases.
Operating
Leases
The
Company leases office space in Miami, Florida and research and development laboratory space in Bothell, Washington under operating leases
that expire on August 31, 2024 and January 31, 2029, respectively. For operating leases, the weighted average discount rate is 6.0% and
the weighted average remaining lease term is 5.9 years.
The
following table summarizes the Company’s maturities of operating lease liabilities, by year and in aggregate, as of June 30, 2024
(table in thousands):
Schedule
of Maturities of Operating Lease Liabilities
| |
| | |
2024 (excluding the six months ended June 30, 2024) | |
$ | 178 | |
2025 | |
| 344 | |
2026 | |
| 355 | |
2027 | |
| 365 | |
2028 | |
| 376 | |
2029 and thereafter | |
| 513 | |
Total operating lease payments | |
| 2,131 | |
Less: present value discount | |
| (351 | ) |
Total operating lease liabilities | |
$ | 1,780 | |
As
of June 30, 2024, the total operating lease liability of $251,000 is classified as a current operating lease liability.
The
operating lease liabilities summarized above do not include variable common area maintenance (the “CAM”) charges, which are
contractual liabilities under the Company’s Bothell, Washington lease. CAM charges for the Bothell, Washington facility are calculated
annually based on actual common expenses for the building incurred by the lessor and proportionately billed to tenants based on leased
square footage. For the six months ended June 30, 2024 and 2023, approximately $95,000 and $54,000 of CAM was included in general and
administrative operating expenses on the condensed consolidated statements of operations, respectively.
The
minimum lease payments above include the amounts that would be paid if the Company maintains its Bothell lease for the five-year term,
starting February 2024.
On
September 1, 2021, the Company entered into a three-year lease extension with a limited liability company controlled by Dr. Phillip Frost,
a director and a principal stockholder of the Company. On an annualized basis, straight-line rent expense is approximately $62,000, including
fixed and estimable fees and taxes. The Company intends to renew the lease following expiration in 2024.
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.
For
the six months ended June 30, 2024 and 2023, operating lease expense, excluding short-term leases, finance leases and CAM charges, totaled
approximately $189,000 and $116,000, respectively, of which $31,000 and $26,000 for each period was to a related party.
Finance
Leases
In
April 2020, the Company entered into lease agreements to acquire lab equipment with 36 monthly payments of $2,000 payable through March
31, 2023. The final payment under the lease agreement was made in March 2023 and the title of the equipment has transferred title to
the Company.
The
leased lab equipment is depreciable over five years and is presented net of accumulated depreciation on the condensed consolidated balance
sheets under property and equipment. As of December 31, 2023, total right-of-use assets lab equipment exchanged for finance lease liabilities
was $162,000 and accumulated depreciation for lab equipment under finance leases was $162,000. The remaining lab equipment under the
finance lease terminated on March 31, 2023, and due to the leased equipment’s remaining 25 months of useful life, it was transferred
to fixed assets at book value of $32,000 and continues to depreciate.
Phase
2a Clinical Trial
On
August 3, 2022 the Company engaged hVIVO, a subsidiary of London-based Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract
research organization (“CRO”), to conduct a Phase 2a clinical trial with the Company’s novel, broad-spectrum, orally
administered antiviral influenza candidate. The Company prepaid a reservation fee of $1.7 million upon execution of the agreement. As
of June 30, 2024 the Company expensed $1.7 million leaving no balance in prepaid and other expenses. In addition, the Company incurred
additional costs of $1.7 million on this agreement during the six months ending June 30, 2024.
The
total estimated cost of the agreement (including the reservation fee) is approximately $6.9 million.
On
May 21, 2024, the Company entered into a new agreement with hVIVO, as a follow-on to CPI-CST-001 Influenza virus challenge study, in
which potential resistance to CC-42344 antiviral compound will be genotypically characterized. The Company incurred $45,000 on this agreement
for three months ended June 30, 2024. The total estimated cost of this agreement is approximately $227,000.
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.
10.
Transactions with Related Parties
On
September 1, 2021, the Company entered into a three-year lease extension with a limited liability company controlled by Dr. Phillip Frost,
a director and a principal stockholder of the Company. For the six months ended June 30, 2024 and 2023, rent expense was approximately
$31,000 for each period, including fixed and estimable fees and taxes. The Company intends to renew the lease following expiration in
2024.
On
April 4, 2023, the Company entered into a Securities Purchase Agreement with two accredited investors (the “Purchasers”)
whereby the Purchasers agreed to purchase a total of 2,030,458 shares of unregistered common stock at a price of $1.97 per share for
a total purchase price of $4,000,000 in two equal $2,000,000 investments. The Purchasers were an entity controlled by a director and
another investor who subsequently joined the Company’s Board of Directors.
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Overview
Cocrystal
Pharma, Inc. (the “Company” or “Cocrystal”) is a clinical-stage biotechnology company seeking to discover and
develop novel antiviral therapeutics as treatments for serious and/or chronic viral diseases. We employ unique structure-based technologies
and Nobel Prize winning expertise to create first- and best-in-class antiviral drugs. These technologies are designed to efficiently
deliver small molecule therapeutics that are safe, effective and convenient to administer. We have identified promising preclinical and
clinical-stage antiviral compounds for unmet medical needs including influenza virus, coronavirus, norovirus and hepatitis C virus (“HCV”).
Research
and Development Update
During
the six months ended June 30, 2024 and more recently the Company continued to focus its research and development efforts primarily in
three areas. The following is an overview of the characteristics, goals and development progress of each of these programs.
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 for the treatment of pandemic and seasonal influenza A. Oral CC-42344 was advanced to a Phase 2a influenza human challenge
clinical study as described in more detail below. This drug 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 antiviral activity against influenza A strains, including
avian pandemic strains and strains resistant to Tamiflu® and Xofluza, and has favorable pharmacokinetic and drug resistance profiles.
This drug candidate was specifically designed and developed using Cocrystal’s proprietary structure-based drug discovery platform
technology.
We
received authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) to initiate a Phase 2a human
challenge study with oral CC-42344 as a potential treatment for pandemic and seasonal influenza A. This ongoing randomized, double-blind,
placebo-controlled study is evaluating the safety, tolerability, viral and clinical measurements of influenza A infection in subjects
dosed with oral CC-42344 treatment. In May 2024 we announced completion of enrollment of 78 subjects.
In
June 2024 we reported the potential efficacy of CC-42344 against the new avian flu strain with the recently published genome sequence
for H5N1. Using our proprietary structure-based platform technology, Cocrystal created a high-resolution crystal structure of this avian
PB2 protein and confirmed that CC-42344 binds to its highly conserved PB2 region. The in vitro data generated testing CC-42344 against
the avian H5N1 PB2 protein showed a desired level of CC-42344’s activity similar to that of Cocrystal’s data in other strains
of pandemic and seasonal influenza A.
![](https://www.sec.gov/Archives/edgar/data/1412486/000149315224031877/form10-q_002.jpg)
CC-42344
binds to the highly conserved region of the avian influenza A H5N1 PB2 protein
In
addition to oral CC-42344, we developed inhaled CC-42344 for the prophylactic treatment of pandemic and seasonal influenza A infections.
Our preclinical data of inhaled CC-42344 showed excellent antiviral activity in influenza H1N1-infected human upper airway epithelium
with a favorable safety profile. We completed inhalation formulation development and are conducting 14-day GLP toxicology study.
We
also continue developing novel broad-spectrum influenza antivirals targeting replication enzymes of influenza A and B strains.
Norovirus
and Coronavirus Programs
We
developed novel protease inhibitor CDI-988 as an oral pan-viral treatment of noroviruses and coronavirus, 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 is being clinically evaluated for safety, tolerability and pharmacokinetics including a food-effect cohort in healthy volunteers
in a single-center, randomized, double-blind, placebo-controlled Phase 1 study being conducted in Australia.
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.
Therapeutic
Targets
Influenza:
A worldwide public health problem, including the potential for pandemic disease.
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
that are 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 isolated 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.
Coronavirus:
COVID-19 continues to be a global pandemic fueled by an emergence of new strains.
COVID-19
is a global pandemic with 775,673,955 confirmed cases globally, including 7,053,524 deaths, as of July 7, 2024, 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 the recent 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 Delta and Omicron variants as well as the more recent JN.1 strain, 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 use to treat COVID-19 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).
Norovirus:
A worldwide public health problem responsible for close to 90% of epidemic, non-bacterial outbreaks of gastroenteritis around the world
with no effective treatment.
Norovirus
is a very common and highly contagious virus that causes symptoms of acute gastroenteritis among people of all ages. Norovirus infection
can be significantly more severe and prolonged in specific risk groups including infants, children, the elderly and people with immunodeficiency.
Symptoms include nausea, vomiting, stomach pain and diarrhea as well as fatigue, fever and dehydration. 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 responsible for an estimated 21 million cases
annually, including 109,000 hospitalizations, 465,000 emergency department visits and nearly 900 deaths, according to the CDC. The NIH
estimates the annual burden to the United States at $10.6 billion. Noroviruses are responsible for up to 1.1 million hospitalizations
and 218,000 deaths annually in children in the developing world. In immunosuppressed patients, chronic norovirus infection can lead to
a debilitating illness with extended periods of nausea, vomiting and diarrhea.
There
is currently no effective treatment or effective vaccine for norovirus, and the ability to curtail outbreaks is limited. We have a norovirus
therapeutic candidate in clinical testing. 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).
By
targeting viral replication enzymes and a viral protease, we believe it is possible to develop an effective treatment for all genogroups
of norovirus. Also, because of the significant unmet medical need and the possibility of chronic norovirus infection in immunocompromised
individuals, new antiviral therapeutic and prophylactic approaches may warrant an accelerated path to market. We are developing inhibitors
of the RNA-dependent RNA polymerase and protease of norovirus. These enzymes are essential to viral replication and are highly conserved
between all noroviral genogroups. Therefore, an inhibitor of these enzymes might be an effective treatment or short-term prophylactic
agent, when administered during a cruise or nursing home stay, for example. We have developed X-ray quality norovirus polymerase and
protease crystals and have identified promising inhibitors. We are implementing the platform and approaches that have proven successful
in our other antiviral programs.
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 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. 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. We have completed the Phase 2a final study report as filed
with the FDA. See “Item 1 – Business – Research and Development Update – Hepatitis C” in our Annual Report
on Form 10-K for the year ended December 31, 2023 for more information.
We
have been seeking a partner for further clinical development of CC-31244 since completing Phase 2a trials.
Results
of Operations for the Six Months Ended June 30, 2024 compared to the Six Months Ended June 30, 2023
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 June 30, 2024, and 2023 were $4,308,000 and $2,801,000, respectively. The
increase of $1,507,000 was primarily due to our Influenza CC-42344 product candidate
entering into a Phase 2a clinical trial and our norovirus and coronavirus candidate CDI-988 entering into
a Phase 1 clinical trial.
Total
research and development expenses for the six months ended June 30, 2024, and 2023 were $7,258,000 and $6,708,000, respectively. The
increase of $550,000 was primarily due ongoing clinical trials described above.
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 June 30, 2024, and 2023 were $1,140,000 and $1,538,000, respectively. The decrease
of $398,000 was primarily due to a reduction of litigation expenses.
General
and administrative expenses for the six months ended June 30, 2024, and 2023 were $2,348,000 and $2,742,000, respectively. The decrease
of $394,000 was primarily due to a reduction of litigation expenses.
Interest
Income, Net
Interest
income for the three months ended June 30, 2024 and 2023 was $151,000 and $140,000, respectively, and for the six months ended June 30,
2024 and 2023 was $371,000 and $140,000, 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. Foreign
exchange loss during the six months ended June 30, 2024, and 2023 was $64,000 and $45,000, respectively.
Income
Taxes
No
income tax benefit or expense was recognized for the three and six months ended June 30, 2024 and 2023. The Company’s effective
income tax rate was 0.00% and 0.00% for the three and six months ended June 30, 2024 and 2023. 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 six months ended June 30, 2024 was $5,343,000 and $9,299,000, compared
with a net loss of $4,166,000 and $9,355,000 for the three and six months ended June 30, 2023, respectively, primarily as a result
of operations described above.
Liquidity
and Capital Resources
Net
cash used in operating activities was $8,202,000 for the six months ended June 30, 2024 compared with net cash used in operating activities
of $8,659,000 for the same period in 2023. This decrease was primarily due to period expenses related to the completion of our COVID-19
Phase 1 clinical trial and completion of our Influenza A Phase 2a clinical trial and preparation for our anticipated Influenza A Phase
1 inhaler administer medicine clinical trial and completion of our COVID-19 Phase 1 clinical trial.
We
used $8,000 net cash for investing activities during the six months ended June 30, 2024 compared with $59,000 net cash used for the same
period in 2023. For the six months ended June 30, 2024 the level of investments decreased compared with June 30, 2023 due to comparative
reduction in purchases of laboratory equipment in 2024.
Net
cash used in financing activities totaled $0 for the six months ended June 30, 2024 compared with net cash used in financing activities
of $3,993,000 for the same period in 2023 due to sufficient capital resulting in a lack of financing activity in the 2024 period.
The
Company has not yet established an ongoing source of revenue sufficient to cover its operating costs. The Company had $18,143,000 unrestricted
cash on June 30, 2024. The Company believes it has sufficient cash to maintain planned operations for more than the next 12 months.
We
have focused our efforts on research and development activities, including through collaborations with suitable partners. We have been
profitable on a quarterly basis but have never been profitable on an annual basis. We have no products approved for sale and have incurred
operating losses and negative operating cash flows on an annual basis since inception.
The
Company’s interim consolidated financial statements are prepared using generally accepted accounting principles in the United States
of America applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal
course of business. Historically, public and private equity offerings have been our principal source of liquidity.
The
Company is party to the At-The-Market Offering Agreement, dated July 1, 2020 (“ATM Agreement”) with H.C. Wainwright &
Co., LLC (“Wainwright”), pursuant to which the Company may issue and sell over time and from time to time, to or through
Wainwright, up to $10,000,000 of shares of the Company’s common stock. During January 2021, the Company sold 1,030,000 shares of
its common stock pursuant to the ATM Agreement for net proceeds of approximately $2,072,000. 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 six months ended
June 30, 2024.
As
the Company continues to incur losses, achieving profitability is dependent upon the successful development, approval and commercialization
of its product candidates, and achieving a level of revenues adequate to support the Company’s cost structure. The Company may
never achieve profitability, and unless and until it does, the Company will continue to need to raise additional capital. Management
intends to fund future operations through additional private or public equity offerings and through arrangements with strategic partners
or from other sources. There can be no assurances, however, that additional funding will be available on terms acceptable to the Company,
or at all, and any equity financing may be very dilutive to existing stockholders.
Cautionary
Note Regarding Forward-Looking Statements
This
report includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements
regarding the future effectiveness of our product candidates, our plans for the future development of preclinical and clinical drug candidates,
the 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.
The
results anticipated by any or all of these forward-looking statements might not occur. Important factors that could cause actual results
to differ from those in the forward-looking statements include the risks and uncertainties arising from the risks arising from inflation,
interest rate increases, the possibility of a recession and the economic impact of the wars in Israel and Ukraine on our Company, our
collaboration partners, and on the U.S., U.K., Australia and global economies, including downturns in economic activity and capital markets,
manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions
including any adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors and
our current and any future 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, 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, 2023. 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, 2023, 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, 2023 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 June 30, 2024 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 June 30, 2024. 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.
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 June 30, 2024.
ITEM
1.A RISK FACTORS
None.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
All
recent sales of unregistered securities have been previously reported.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
4. MINE SAFETY DISCLOSURES
Not
applicable.
ITEM
5. OTHER INFORMATION
During
the six months ended June 30, 2024, none of our directors or officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted or
terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative
defense conditions of Rule 10b5-1(c) under the Exchange Act or any “non-Rule 10b5-1 arrangement” as defined in Item 408(c)
of Regulation S-K.
ITEM
6. EXHIBITS
The
exhibits listed in the accompanying “Exhibit Index” are filed or incorporated by reference as part of this Form 10-Q.
EXHIBIT
INDEX
*
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.
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:
August 14, 2024 |
By:
|
/s/
Sam Lee |
|
|
Sam
Lee |
|
|
President
and Co-Chief Executive Officer |
|
|
(Principal
Executive Officer) |
|
|
|
Dated:
August 14, 2024 |
By:
|
/s/
James Martin |
|
|
James
Martin |
|
|
Chief
Financial Officer and Co-Chief
Executive
Officer |
|
|
(Principal
Executive Officer and Principal Financial Officer) |
Exhibit
31.1
CERTIFICATION
OF PRINCIPAL EXECUTIVE OFFICER
I,
Sam Lee, certify that:
1.
I have reviewed this quarterly report on Form 10-Q of Cocrystal Pharma, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons
performing the equivalent functions):
a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date:
August 14, 2024
/s/
Sam Lee |
|
Sam
Lee |
|
President
and Co-Chief Executive Officer |
|
(Principal
Executive Officer) |
|
Exhibit
31.2
CERTIFICATION
OF PRINCIPAL EXECUTIVE OFFICER
I,
James Martin, certify that:
1.
I have reviewed this quarterly report on Form 10-Q of Cocrystal Pharma, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons
performing the equivalent functions):
a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date:
August 14, 2024
/s/
James Martin |
|
James
Martin |
|
Co-Chief
Executive Officer |
|
(Principal
Executive Officer) |
|
Exhibit
31.3
CERTIFICATION
OF PRINCIPAL FINANCIAL OFFICER
I,
James Martin, certify that:
1.
I have reviewed this quarterly report on Form 10-Q of Cocrystal Pharma, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons
performing the equivalent functions):
a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date:
August 14, 2024
/s/
James Martin |
|
James
Martin |
|
Chief
Financial Officer |
|
(Principal
Financial Officer) |
|
Exhibit
32.1
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the quarterly report of Cocrystal Pharma, Inc. (the “Company”) on Form 10-Q for the quarter ended June 30,
2024, as filed with the Securities and Exchange Commission on the date hereof, I, Sam Lee, certify, pursuant to 18 U.S.C. Sec.1350, as
adopted pursuant to Sec.906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
1.
The quarterly report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934 and
2.
The information contained in the quarterly report fairly presents, in all material respects, the financial condition and results of operations
of the Company.
/s/
Sam Lee |
|
Sam
Lee |
|
President
and Co-Chief Executive Officer |
|
(Principal
Executive Officer) |
|
Dated:
August 14, 2024
In
connection with the quarterly report of Cocrystal Pharma, Inc. (the “Company”) on Form 10-Q for the quarter ended June 30,
2024, as filed with the Securities and Exchange Commission on the date hereof, I, James Martin, certify, pursuant to 18 U.S.C. Sec.1350,
as adopted pursuant to Sec.906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
1.
The quarterly report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934 and
2.
The information contained in the quarterly report fairly presents, in all material respects, the financial condition and results of operations
of the Company.
/s/
James Martin |
|
James
Martin |
|
Chief
Financial Officer and Co-Chief Executive Officer |
|
(Principal
Executive Officer and Principal Financial Officer) |
|
Dated:
August 14, 2024
v3.24.2.u1
Cover - $ / shares
|
6 Months Ended |
|
Jun. 30, 2024 |
Aug. 14, 2024 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Jun. 30, 2024
|
|
Document Fiscal Period Focus |
Q2
|
|
Document Fiscal Year Focus |
2024
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-38418
|
|
Entity Registrant Name |
COCRYSTAL
PHARMA, INC.
|
|
Entity Central Index Key |
0001412486
|
|
Entity Tax Identification Number |
35-2528215
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
19805
North Creek Parkway
|
|
Entity Address, City or Town |
Bothell
|
|
Entity Address, State or Province |
WA
|
|
Entity Address, Postal Zip Code |
98011
|
|
City Area Code |
877
|
|
Local Phone Number |
262-7123
|
|
Title of 12(b) Security |
Common
Stock
|
|
Trading Symbol |
COCP
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
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Yes
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v3.24.2.u1
Condensed Consolidated Balance Sheets - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash |
$ 18,143,000
|
$ 26,353,000
|
Restricted cash |
75,000
|
75,000
|
Tax credit receivable |
1,077,000
|
890,000
|
Prepaid expenses and other current assets |
365,000
|
1,773,000
|
Total current assets |
19,660,000
|
29,091,000
|
Property and equipment, net |
211,000
|
271,000
|
Deposits |
29,000
|
46,000
|
Operating lease right-of-use assets, net (including $11 and $42 to related party) |
1,673,000
|
1,851,000
|
Total assets |
21,573,000
|
31,259,000
|
Current liabilities: |
|
|
Accounts payable and accrued expenses |
2,403,000
|
3,022,000
|
Current maturities of operating lease liabilities (including $10 and $42 to related party) |
251,000
|
240,000
|
Total current liabilities |
2,654,000
|
3,262,000
|
Long-term liabilities: |
|
|
Operating lease liabilities (including $0 and $0 to related party) |
1,529,000
|
1,613,000
|
Total long-term liabilities |
1,529,000
|
1,613,000
|
Total liabilities |
4,183,000
|
4,875,000
|
Commitments and contingencies |
|
|
Stockholders’ equity: |
|
|
Common stock, $0.001 a par value: 100,000 and 150,000 shares authorized as of June 30, 2024, and December 31, 2023; 10,174 shares issued and outstanding as of June 30, 2024 and December 31, 2023 |
10,000
|
10,000
|
Additional paid-in capital |
342,593,000
|
342,288,000
|
Accumulated deficit |
(325,213,000)
|
(315,914,000)
|
Total stockholders’ equity |
17,390,000
|
26,384,000
|
Total liabilities and stockholders’ equity |
$ 21,573,000
|
$ 31,259,000
|
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Jun. 30, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
Operating lease right of use assets related party |
$ 11
|
$ 42
|
Operating lease liabilities related party current |
10
|
42
|
Operating lease liabilities related party non-current |
$ 0
|
$ 0
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
100,000,000
|
150,000,000
|
Common stock, shares issued |
10,174,000
|
10,174,000
|
Common stock, shares outstanding |
10,174,000
|
10,174,000
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.2.u1
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Operating expenses: |
|
|
|
|
Research and development |
$ 4,308,000
|
$ 2,801,000
|
$ 7,258,000
|
$ 6,708,000
|
General and administrative |
1,140,000
|
1,538,000
|
2,348,000
|
2,742,000
|
Total operating expenses |
5,448,000
|
4,339,000
|
9,606,000
|
9,450,000
|
Loss from operations |
(5,448,000)
|
(4,339,000)
|
(9,606,000)
|
(9,450,000)
|
Other income (expense): |
|
|
|
|
Interest income, net |
151,000
|
140,000
|
371,000
|
140,000
|
Foreign exchange gain (loss) |
(46,000)
|
33,000
|
(64,000)
|
(45,000)
|
Total other expense, net |
105,000
|
173,000
|
307,000
|
95,000
|
Net loss |
$ (5,343,000)
|
$ (4,166,000)
|
$ (9,299,000)
|
$ (9,355,000)
|
Net loss per common share, basic |
$ (0.53)
|
$ (0.41)
|
$ (0.91)
|
$ (1.03)
|
Net loss per common share, diluted |
$ (0.53)
|
$ (0.41)
|
$ (0.91)
|
$ (1.03)
|
Weighted average number of common shares outstanding, basic |
10,174
|
10,065
|
10,174
|
9,109
|
Weighted average number of common shares outstanding, diluted |
10,174
|
10,065
|
10,174
|
9,109
|
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v3.24.2.u1
Condensed Consolidated Statements of Stockholders' Equity - USD ($) shares in Thousands |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2022 |
$ 8,000
|
$ 337,489,000
|
$ (297,930,000)
|
$ 39,567,000
|
Balance, shares at Dec. 31, 2022 |
8,143
|
|
|
|
Stock-based compensation |
|
291,000
|
|
291,000
|
Net loss |
|
|
(5,189,000)
|
(5,189,000)
|
Balance at Mar. 31, 2023 |
$ 8,000
|
337,780,000
|
(303,119,000)
|
34,669,000
|
Balance, shares at Mar. 31, 2023 |
8,143
|
|
|
|
Balance at Dec. 31, 2022 |
$ 8,000
|
337,489,000
|
(297,930,000)
|
39,567,000
|
Balance, shares at Dec. 31, 2022 |
8,143
|
|
|
|
Net loss |
|
|
|
(9,355,000)
|
Balance at Jun. 30, 2023 |
$ 10,000
|
341,957,000
|
(307,285,000)
|
34,682,000
|
Balance, shares at Jun. 30, 2023 |
10,174
|
|
|
|
Balance at Mar. 31, 2023 |
$ 8,000
|
337,780,000
|
(303,119,000)
|
34,669,000
|
Balance, shares at Mar. 31, 2023 |
8,143
|
|
|
|
Stock-based compensation |
|
179,000
|
|
179,000
|
Net loss |
|
|
(4,166,000)
|
(4,166,000)
|
Sale of common stock, net of transaction costs |
$ 2,000
|
3,998,000
|
|
4,000,000
|
Sale of common stock, net of transaction costs, shares |
2,031
|
|
|
|
Balance at Jun. 30, 2023 |
$ 10,000
|
341,957,000
|
(307,285,000)
|
34,682,000
|
Balance, shares at Jun. 30, 2023 |
10,174
|
|
|
|
Balance at Dec. 31, 2023 |
$ 10,000
|
342,288,000
|
(315,914,000)
|
26,384,000
|
Balance, shares at Dec. 31, 2023 |
10,174
|
|
|
|
Stock-based compensation |
|
157,000
|
|
157,000
|
Net loss |
|
|
(3,956,000)
|
(3,956,000)
|
Balance at Mar. 31, 2024 |
$ 10,000
|
342,445,000
|
(319,870,000)
|
22,585,000
|
Balance, shares at Mar. 31, 2024 |
10,174
|
|
|
|
Balance at Dec. 31, 2023 |
$ 10,000
|
342,288,000
|
(315,914,000)
|
26,384,000
|
Balance, shares at Dec. 31, 2023 |
10,174
|
|
|
|
Net loss |
|
|
|
(9,299,000)
|
Balance at Jun. 30, 2024 |
$ 10,000
|
342,593,000
|
(325,213,000)
|
17,390,000
|
Balance, shares at Jun. 30, 2024 |
10,174
|
|
|
|
Balance at Mar. 31, 2024 |
$ 10,000
|
342,445,000
|
(319,870,000)
|
22,585,000
|
Balance, shares at Mar. 31, 2024 |
10,174
|
|
|
|
Stock-based compensation |
|
148,000
|
|
148,000
|
Net loss |
|
|
(5,343,000)
|
(5,343,000)
|
Balance at Jun. 30, 2024 |
$ 10,000
|
$ 342,593,000
|
$ (325,213,000)
|
$ 17,390,000
|
Balance, shares at Jun. 30, 2024 |
10,174
|
|
|
|
X |
- DefinitionAmount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement.
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v3.24.2.u1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Operating activities: |
|
|
Net loss |
$ (9,299,000)
|
$ (9,355,000)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation and amortization expense |
68,000
|
96,000
|
Stock-based compensation |
305,000
|
470,000
|
Changes in operating assets and liabilities: |
|
|
Prepaid expenses and other current assets |
1,408,000
|
183,000
|
Deposits |
17,000
|
|
Tax credit receivable |
(187,000)
|
(491,000)
|
Decrease in right of use assets |
178,000
|
108,000
|
Accounts payable and accrued expenses |
(619,000)
|
445,000
|
Operating lease liabilities |
(73,000)
|
(115,000)
|
Net cash used in operating activities |
(8,202,000)
|
(8,659,000)
|
Investing activities: |
|
|
Purchases of property and equipment |
(8,000)
|
(59,000)
|
Net cash used in investing activities |
(8,000)
|
(59,000)
|
Financing activities: |
|
|
Payments on finance lease liabilities |
|
(7,000)
|
Proceeds from sale of common stock, net of transaction costs |
|
4,000,000
|
Net cash used in financing activities |
|
3,993,000
|
Net decrease in cash and restricted cash |
(8,210,000)
|
(4,725,000)
|
Cash and restricted cash at beginning of period |
26,428,000
|
37,219,000
|
Cash and restricted cash at end of period |
$ 18,218,000
|
$ 32,494,000
|
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v3.24.2.u1
Pay vs Performance Disclosure - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Pay vs Performance Disclosure [Table] |
|
|
|
|
|
|
Net Income (Loss) |
$ (5,343,000)
|
$ (3,956,000)
|
$ (4,166,000)
|
$ (5,189,000)
|
$ (9,299,000)
|
$ (9,355,000)
|
X |
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v3.24.2.u1
Organization and Business
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Organization and Business |
1.
Organization and Business
Cocrystal
Pharma, Inc. (“we”, the “Company” or “Cocrystal”), a clinical stage biopharmaceutical company incorporated
in Delaware, has been developing novel technologies and approaches to create first-in-class or best-in-class antiviral drug candidates.
Our focus is to pursue the development and commercialization of broad-spectrum antiviral drug candidates that will transform the treatment
and prophylaxis of viral diseases in humans. By concentrating our research and development efforts on viral replication inhibitors, we
plan to leverage our infrastructure and expertise in these areas.
The
Company’s activities since inception have principally consisted of acquiring product and technology rights, raising capital, and
performing research and development. Successful completion of the Company’s development programs, obtaining regulatory approvals
of its products and, ultimately, the attainment of profitable operations is dependent on future events, including, among other things,
its ability to access potential markets, secure financing, develop a customer base, attract, retain and motivate qualified personnel,
and develop strategic alliances. Through June 30, 2024, the Company has primarily funded its operations through equity offerings.
Liquidity
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 six months ended June 30, 2024, the Company recorded a net loss of approximately
$9,299,000 and used approximately $8,202,000 of cash in operating activities.
On June 30, 2024, the Company had cash and cash equivalents
of approximately $18,143,000. We believe that our current resources will be sufficient to fund our operations beyond the next 12 months.
This estimate is based, in part, upon our currently projected expenditures.
The Company’s activities since inception have
principally consisted of acquiring product and technology rights, raising capital, and performing research and development. Successful
completion of the Company’s development programs, obtaining regulatory approvals of its products and, ultimately, the attainment
of profitable operations is dependent on future events, including, among other things, its ability to access potential markets, secure
financing, develop a customer base, attract, retain and motivate qualified personnel, and develop strategic alliances. Through June 30,
2024, the Company has primarily funded its operations through equity offerings.
The Company will need to continue obtaining adequate
capital to fund operating losses until it becomes profitable. The Company can give no assurances that the additional capital it is able
to raise, if any, will be sufficient to meet its needs, or that any such financing will be obtainable on acceptable terms. Our future
cash requirements, and the timing of those requirements, will depend on a number of factors, including economic conditions, the approval
and success of our products in development, the continued progress of research and development of our product candidates, the timing and
outcome of clinical trials and regulatory approvals, the costs involved in preparing, filing, prosecuting, maintaining, defending, and
enforcing patent claims and other intellectual property rights, the status of competitive products, the availability of financing, our
success in developing markets for our product candidates and legal proceedings that may arise. We have historically not generated sustained
positive cash flow and if we are not able to secure additional funding when needed, we may have to delay, reduce the scope of, or eliminate
one or more of our clinical trials or research and development programs. If the Company is unable to obtain adequate capital, it could
be forced to cease operations or substantially curtail its drug development activities. The Company expects to continue incurring substantial
operating losses and negative cash flows from operations over the next several years during its pre-clinical and clinical development
phases.
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v3.24.2.u1
Basis of Presentation and Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Basis of Presentation and Significant Accounting Policies |
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, 2023 filed
on March 28, 2024 (“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 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 June 30, 2024 and December 31, 2023, our primary operating accounts held approximately $7,536,000 and $16,322,000,
respectively, and our collateral account balance was $75,000 and $75,000 at a different institution. The Company has not experienced
any losses in such accounts and believes it is not exposed to significant risks thereof.
Foreign
Currency Transactions
The
Company and its subsidiaries use the U.S. dollar as functional currency. Foreign currency transactions are initially measured and recorded
in the functional currency using the exchange rate on the date of the transaction. Foreign exchange gains and losses arising from settlement
of foreign currency transactions are recognized in profit and loss.
Cocrystal
Australia maintains its records in Australian dollars. The monetary assets and liabilities of Cocrystal Australia are remeasured into
the functional currency using the closing rate at the end of every reporting period. All nonmonetary assets and liabilities and related
profit and loss accounts are remeasured into the functional currency using the historical exchange rates. Profit and loss accounts, other
than those that are remeasured using the historical exchange rates, are remeasured into the functional currency using the average exchange
rate for the period. Foreign exchange gains and losses arising from the remeasurement into the functional currency is recognized in profit
and loss.
Fair
Value Measurements
FASB
Accounting Standards Codification (“ASC”) 820 defines fair value, establishes a framework for measuring fair value under
U.S. GAAP and enhances disclosures about fair value measurements. Fair value is defined under ASC 820 as the exchange price that would
be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or
liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value
under ASC 820 must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes a fair value
hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used
to measure fair value which are the following:
|
Level
1 — quoted prices in active markets for identical assets or liabilities. |
|
|
|
Level
2 — other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement
date. |
|
|
|
Level
3 — significant unobservable inputs that reflect management’s best estimate of what market participants would use to
price the assets or liabilities at the measurement date. |
At
June 30, 2024 and December 31, 2023, the carrying amounts of financial assets and liabilities, such as cash, other current 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, 2023, balance of Refundable Tax Credits was approximately $786,000. The Company estimated
and accrued Refundable Tax Credits for the six months ended June 30, 2024 of approximately $264,000, resulting in a total balance of
Refundable Tax Credits receivable of approximately $1,050,000 as of the period then ended.
Income
Taxes
The
Company accounts for income taxes under the asset and liability method. Under this method, deferred tax assets and liabilities are determined
based on differences between financial reporting and tax bases of assets and liabilities and are measured using enacted tax rates and
laws that are expected to be in effect when the differences are expected to be recovered or settled. Realization of deferred tax assets
is dependent upon future taxable income. A valuation allowance is recognized if it is more likely than not that some portion or all of
a deferred tax asset will not be realized based on the weight of available evidence, including expected future earnings. The Company
recognizes an uncertain tax position in its financial statements when it concludes that a tax position is more likely than not to be
sustained upon examination based solely on its technical merits. Only after a tax position passes the first step of recognition will
measurement be required. Under the measurement step, the tax benefit is measured as the largest amount of benefit that is more likely
than not to be realized upon effective settlement. This is determined on a cumulative probability basis. The full impact of any change
in recognition or measurement is reflected in the period in which such change occurs. The Company elects to accrue any interest or penalties
related to income taxes as part of its income tax expense.
As
of June 30, 2024, the Company assessed its income tax expense based on its projected future taxable income for the year ending December
31, 2024 and therefore recorded no amount for income tax expense for the six months ended June 30, 2024. 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, 2023 for more information.
Stock-Based
Compensation
The
Company recognizes compensation expense using a fair value-based method for costs related to stock-based payments, including stock options.
The fair value of options awarded to employees is measured on the date of grant using the Black-Scholes option pricing model and is recognized
as expense over the requisite service period on a straight-line basis.
Use
of the Black-Scholes option pricing model requires the input of subjective assumptions including expected volatility, expected term,
and a risk-free interest rate. The Company estimates volatility using a blend of its own historical stock price volatility as well as
that of market comparable entities since the Company’s common stock has limited trading history and limited observable volatility
of its own. The expected term of the options is estimated by using the SEC Staff Bulletin No. 107’s Simplified Method for Estimate
Expected Term. The risk-free interest rate is estimated using comparable published federal funds rates.
Common
Stock Purchase Warrants and Other Derivative Financial Instruments
We
classify as equity any contracts that require physical settlement or net-share settlement or provide us a choice of net-cash settlement
or settlement in our own shares (physical settlement or net-share settlement) provided that such contracts are indexed to our own stock
as defined in ASC 815-40, Contracts in Entity’s Own Equity. We classify as assets or liabilities any contracts that require
net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside our control)
or give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement). We assess
classification of our common stock purchase warrants and other freestanding derivatives at each reporting date to determine whether a
change in classification between assets and liabilities is required.
Net
Income (Loss) per Share
The
Company accounts for and discloses net income (loss) per common share in accordance with FASB ASC Topic 260, Earnings Per Share.
Basic income (loss) per common share is computed by dividing income (loss) attributable to common stockholders by the weighted average
number of common shares outstanding. Diluted net income (loss) per common share is computed by dividing net income (loss) attributable
to common stockholders by the weighted average number of common shares that would have been outstanding during the period assuming the
issuance of common stock for all potential dilutive common shares outstanding. Potential common shares consist of shares issuable upon
the exercise of stock options and warrants and the conversion of convertible notes payable.
The
following table sets forth the number of potential common shares excluded from the calculations of net loss per diluted share because
their inclusion would be anti-dilutive (in thousands):
Schedule of Anti-dilutive Securities Excluded from Calculations of Net Loss Per Share
| |
2024 | | |
2023 | |
| |
June 30, | |
| |
2024 | | |
2023 | |
Outstanding options to purchase common stock | |
| 555 | | |
| 350 | |
Warrants to purchase common stock | |
| - | | |
| 13 | |
Total | |
| 555 | | |
| 363 | |
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.
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v3.24.2.u1
Property and Equipment
|
6 Months Ended |
Jun. 30, 2024 |
Property, Plant and Equipment [Abstract] |
|
Property and Equipment |
3.
Property and Equipment
Property
and equipment are recorded at cost and depreciated over the estimated useful lives of the underlying assets (three to five years) using
the straight-line method. As of June 30, 2024, and December 31, 2023, property and equipment consists of (table in thousands):
Schedule of Property and Equipment
| |
June 30, 2024 | | |
December 31, 2023 | |
Lab equipment (excluding equipment under finance leases) | |
$ | 1,765 | | |
$ | 1,757 | |
Finance lease right-of-use lab equipment obtained in exchange for finance lease liabilities, net | |
| 162 | | |
| 162 | |
Computer and office equipment | |
| 155 | | |
| 155 | |
Total property and equipment | |
| 2,082 | | |
| 2,074 | |
Less: accumulated depreciation and amortization | |
| (1,871 | ) | |
| (1,803 | ) |
Property and equipment, net | |
$ | 211 | | |
$ | 271 | |
Total
depreciation and amortization expense were approximately $68,000 and $96,000 for the six months ended June 30, 2024 and 2023, which includes
amortization expense of $0 and $7,164 for the six months ended June 30, 2024 and 2023, respectively, related to assets under finance
lease. For additional finance leases information, refer to Note 9 – Commitments and Contingencies.
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v3.24.2.u1
Accounts Payable and Accrued Expenses
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
Accounts Payable and Accrued Expenses |
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
| |
June 30, 2024 | | |
December 31, 2023 | |
Accounts payable | |
$ | 1,743 | | |
$ | 1,222 | |
Accrued compensation | |
| 156 | | |
| 109 | |
Accrued other expenses | |
| 504 | | |
| 1,691 | |
Total accounts payable and accrued expenses | |
$ | 2,403 | | |
$ | 3,022 | |
Accounts
payable and accrued other expenses contain unpaid general and administrative expenses and costs related to research and development that
have been billed and estimated unbilled, respectively, as of period-end.
|
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- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.24.2.u1
Common Stock and Preferred Stock
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
Common Stock and Preferred Stock |
5.
Common Stock and Preferred Stock
As
of June 30, 2024, 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.
On
June 27, 2024, the Company, following approval of the Company’s stockholders at the 2024 Annual Meeting of Stockholders filed an
amendment to its Certificate of Incorporation with the Secretary of State of the State of Delaware (the “Amendment”) to decrease
the number of shares of authorized capital stock of the Company from 155,000,000 shares of capital stock, consisting of 150,000,000 shares
of common stock and 5,000,000 shares of preferred stock, to 101,000,000 shares of capital stock consisting of 100,000,000 shares of common
stock and 1,000,000 shares of preferred stock. The Amendment became effective on June 27, 2024.
The
Company had 10,174,000 shares of common stock and no shares of preferred stock issued and outstanding as of June 30, 2024, and December
31, 2023.
The
holders of common stock are entitled to one vote for each share of common stock held.
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v3.24.2.u1
Stock Based Awards
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Stock Based Awards |
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 June 30, 2024, 278,000 shares remain available
for future grants under the 2015 Plan.
The
following table summarizes stock option transactions for the 2015 Plan, collectively, for the six months ended June 30, 2024 (in thousands,
except per share amounts):
Schedule of Stock Option Transactions
| |
Number of Shares Available for Grant | | |
Total Options Outstanding | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
Balance at December 31, 2023 | |
| 275 | | |
| 558 | | |
$ | 10.57 | | |
$ | - | |
Exercised | |
| - | | |
| - | | |
| - | | |
| - | |
Granted | |
| - | | |
| - | | |
| - | | |
| - | |
Expired | |
| 3 | | |
| (3 | ) | |
| 4.90 | | |
| - | |
Balance at June 30, 2024 | |
| 278 | | |
| 555 | | |
$ | 10.40 | | |
$ | - | |
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 six months ended June 30, 2024 and 2023, equity-based compensation expense recorded was approximately
148,000 and $179,000 and $305,000 and $241,000, respectively.
As
of June 30, 2024, there was approximately $402,000 of total unrecognized compensation expense related to non-vested stock options that
is expected to be recognized over a weighted average period of 0.9 years. For options granted and outstanding, there were 555,000 options
outstanding which were fully vested or expected to vest, with an aggregate intrinsic value of $0, a weighted average exercise price of
$10.40 and weighted average remaining contractual term of 7.7 years at June 30, 2024. For vested and exercisable options, outstanding
shares totaled 307,000, with an aggregate intrinsic value of $0. These options had a weighted average exercise price of $16.33 per share
and a weighted-average remaining contractual term of 6.8 years at June 30, 2024.
The
aggregate intrinsic value of outstanding and exercisable options at June 30, 2024 was calculated based on the closing price of the Company’s
common stock as reported on The Nasdaq Capital Market on June 30, 2024 of $2.33 per share less the exercise price of the options. The
aggregate intrinsic value is calculated based on the positive difference between the closing fair market value of the Company’s
common stock and the exercise price of the underlying options.
Common
Stock Reserved for Future Issuance
The
following table presents information concerning common stock available for future issuance (in thousands) as of:
Schedule of Common Stock Reserved for Future Issuance
| |
June 30, 2024 | | |
June 30, 2023 | |
Stock options issued and outstanding | |
| 555 | | |
| 350 | |
Shares authorized for future option grants | |
| 278 | | |
| 484 | |
Warrants outstanding | |
| - | | |
| 13 | |
Total | |
| 833 | | |
| 847 | |
|
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Warrants
|
6 Months Ended |
Jun. 30, 2024 |
Warrants |
|
Warrants |
7.
Warrants
The
following is a summary of activity in the number of warrants classified as liabilities outstanding to purchase the Company’s common
stock for the six months ended June 30, 2024 (in thousands):
Schedule
of Warrants Activity
| |
January 2014 Warrants | |
Outstanding, December 31, 2023 | |
| 11 | |
Exercised | |
| - | |
Granted | |
| - | |
Expired | |
| (11 | ) |
Outstanding, June 30, 2024 | |
| - | |
Expiration date: | |
| 1/16/2024 | |
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v3.24.2.u1
Licenses and Collaborations
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Licenses and Collaborations |
8.
Licenses and Collaborations
Merck
Sharp & Dohme Corp.
On
January 2, 2019, the Company entered into an Exclusive License and Research Collaboration Agreement (the “Collaboration Agreement”)
with Merck Sharp & Dohme LLC (“Merck”) to discover and develop certain proprietary influenza A/B antiviral agents. Under
the terms of the Collaboration Agreement, Merck funded research and development for the program, including clinical development, and
was responsible for worldwide commercialization of any products derived from the collaboration. Under the Collaboration Agreement Cocrystal
was eligible to receive payments related to designated development, regulatory and sales milestones with the potential to earn up to
$156,000,000, as well as royalties on product sales. The Collaboration Agreement provided that Merck may terminate the Collaboration
Agreement at any time prior to the first commercial sale of the first product developed under the Collaboration Agreement, in its sole
discretion, without cause.
On
December 15, 2023, the Company received written notice from Merck of Merck’s election to terminate the Collaboration Agreement.
The termination of the Collaboration Agreement took effect on March 14, 2024. According to Merck’s termination notice, Merck determined
there were no existing conditions to continue the collaboration. The termination resulted from the inability to develop the compounds
to meet a specific aspect of Merck’s program. The pending patent applications on compounds covered by the Collaboration Agreement
and previously filed by Merck on behalf of both companies remain in place.
Kansas
State University Research Foundation
Cocrystal
entered into two License Agreement with Kansas State University Research Foundation (the “Foundation”) on February 18, 2020
to further develop certain proprietary broad-spectrum antiviral compounds for the treatment of norovirus and coronavirus infections.
On
February 28, 2024, the Company provided notice to the Foundation of the Company’s election to terminate the 2020 License Agreements.
The terminations, which were made due to the Company’s determination that further development efforts under the License Agreements
would be futile, took effect on March 29, 2024.
|
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v3.24.2.u1
Commitments and Contingencies
|
6 Months Ended |
Jun. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
9.
Commitments and Contingencies
Commitments
In
the ordinary course of business, the Company enters into non-cancellable leases to purchase equipment and for its facilities, including
related party leases (see Note 10 – Transactions with Related Parties). Leases are accounted for as operating leases or finance
leases, in accordance with ASC 842, Leases.
Operating
Leases
The
Company leases office space in Miami, Florida and research and development laboratory space in Bothell, Washington under operating leases
that expire on August 31, 2024 and January 31, 2029, respectively. For operating leases, the weighted average discount rate is 6.0% and
the weighted average remaining lease term is 5.9 years.
The
following table summarizes the Company’s maturities of operating lease liabilities, by year and in aggregate, as of June 30, 2024
(table in thousands):
Schedule
of Maturities of Operating Lease Liabilities
| |
| | |
2024 (excluding the six months ended June 30, 2024) | |
$ | 178 | |
2025 | |
| 344 | |
2026 | |
| 355 | |
2027 | |
| 365 | |
2028 | |
| 376 | |
2029 and thereafter | |
| 513 | |
Total operating lease payments | |
| 2,131 | |
Less: present value discount | |
| (351 | ) |
Total operating lease liabilities | |
$ | 1,780 | |
As
of June 30, 2024, the total operating lease liability of $251,000 is classified as a current operating lease liability.
The
operating lease liabilities summarized above do not include variable common area maintenance (the “CAM”) charges, which are
contractual liabilities under the Company’s Bothell, Washington lease. CAM charges for the Bothell, Washington facility are calculated
annually based on actual common expenses for the building incurred by the lessor and proportionately billed to tenants based on leased
square footage. For the six months ended June 30, 2024 and 2023, approximately $95,000 and $54,000 of CAM was included in general and
administrative operating expenses on the condensed consolidated statements of operations, respectively.
The
minimum lease payments above include the amounts that would be paid if the Company maintains its Bothell lease for the five-year term,
starting February 2024.
On
September 1, 2021, the Company entered into a three-year lease extension with a limited liability company controlled by Dr. Phillip Frost,
a director and a principal stockholder of the Company. On an annualized basis, straight-line rent expense is approximately $62,000, including
fixed and estimable fees and taxes. The Company intends to renew the lease following expiration in 2024.
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.
For
the six months ended June 30, 2024 and 2023, operating lease expense, excluding short-term leases, finance leases and CAM charges, totaled
approximately $189,000 and $116,000, respectively, of which $31,000 and $26,000 for each period was to a related party.
Finance
Leases
In
April 2020, the Company entered into lease agreements to acquire lab equipment with 36 monthly payments of $2,000 payable through March
31, 2023. The final payment under the lease agreement was made in March 2023 and the title of the equipment has transferred title to
the Company.
The
leased lab equipment is depreciable over five years and is presented net of accumulated depreciation on the condensed consolidated balance
sheets under property and equipment. As of December 31, 2023, total right-of-use assets lab equipment exchanged for finance lease liabilities
was $162,000 and accumulated depreciation for lab equipment under finance leases was $162,000. The remaining lab equipment under the
finance lease terminated on March 31, 2023, and due to the leased equipment’s remaining 25 months of useful life, it was transferred
to fixed assets at book value of $32,000 and continues to depreciate.
Phase
2a Clinical Trial
On
August 3, 2022 the Company engaged hVIVO, a subsidiary of London-based Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract
research organization (“CRO”), to conduct a Phase 2a clinical trial with the Company’s novel, broad-spectrum, orally
administered antiviral influenza candidate. The Company prepaid a reservation fee of $1.7 million upon execution of the agreement. As
of June 30, 2024 the Company expensed $1.7 million leaving no balance in prepaid and other expenses. In addition, the Company incurred
additional costs of $1.7 million on this agreement during the six months ending June 30, 2024.
The
total estimated cost of the agreement (including the reservation fee) is approximately $6.9 million.
On
May 21, 2024, the Company entered into a new agreement with hVIVO, as a follow-on to CPI-CST-001 Influenza virus challenge study, in
which potential resistance to CC-42344 antiviral compound will be genotypically characterized. The Company incurred $45,000 on this agreement
for three months ended June 30, 2024. The total estimated cost of this agreement is approximately $227,000.
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.
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.24.2.u1
Transactions with Related Parties
|
6 Months Ended |
Jun. 30, 2024 |
Related Party Transactions [Abstract] |
|
Transactions with Related Parties |
10.
Transactions with Related Parties
On
September 1, 2021, the Company entered into a three-year lease extension with a limited liability company controlled by Dr. Phillip Frost,
a director and a principal stockholder of the Company. For the six months ended June 30, 2024 and 2023, rent expense was approximately
$31,000 for each period, including fixed and estimable fees and taxes. The Company intends to renew the lease following expiration in
2024.
On
April 4, 2023, the Company entered into a Securities Purchase Agreement with two accredited investors (the “Purchasers”)
whereby the Purchasers agreed to purchase a total of 2,030,458 shares of unregistered common stock at a price of $1.97 per share for
a total purchase price of $4,000,000 in two equal $2,000,000 investments. The Purchasers were an entity controlled by a director and
another investor who subsequently joined the Company’s Board of Directors.
|
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v3.24.2.u1
Basis of Presentation and Significant Accounting Policies (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
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, 2023 filed
on March 28, 2024 (“Annual Report”).
|
Principles of Consolidation |
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 |
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 |
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 |
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 June 30, 2024 and December 31, 2023, our primary operating accounts held approximately $7,536,000 and $16,322,000,
respectively, and our collateral account balance was $75,000 and $75,000 at a different institution. The Company has not experienced
any losses in such accounts and believes it is not exposed to significant risks thereof.
|
Foreign Currency Transactions |
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 |
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. |
At
June 30, 2024 and December 31, 2023, the carrying amounts of financial assets and liabilities, such as cash, other current 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 |
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 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, 2023, balance of Refundable Tax Credits was approximately $786,000. The Company estimated
and accrued Refundable Tax Credits for the six months ended June 30, 2024 of approximately $264,000, resulting in a total balance of
Refundable Tax Credits receivable of approximately $1,050,000 as of the period then ended.
|
Income Taxes |
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.
As
of June 30, 2024, the Company assessed its income tax expense based on its projected future taxable income for the year ending December
31, 2024 and therefore recorded no amount for income tax expense for the six months ended June 30, 2024. 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, 2023 for more information.
|
Stock-Based Compensation |
Stock-Based
Compensation
The
Company recognizes compensation expense using a fair value-based method for costs related to stock-based payments, including stock options.
The fair value of options awarded to employees is measured on the date of grant using the Black-Scholes option pricing model and is recognized
as expense over the requisite service period on a straight-line basis.
Use
of the Black-Scholes option pricing model requires the input of subjective assumptions including expected volatility, expected term,
and a risk-free interest rate. The Company estimates volatility using a blend of its own historical stock price volatility as well as
that of market comparable entities since the Company’s common stock has limited trading history and limited observable volatility
of its own. The expected term of the options is estimated by using the SEC Staff Bulletin No. 107’s Simplified Method for Estimate
Expected Term. The risk-free interest rate is estimated using comparable published federal funds rates.
|
Common Stock Purchase Warrants and Other Derivative Financial Instruments |
Common
Stock Purchase Warrants and Other Derivative Financial Instruments
We
classify as equity any contracts that require physical settlement or net-share settlement or provide us a choice of net-cash settlement
or settlement in our own shares (physical settlement or net-share settlement) provided that such contracts are indexed to our own stock
as defined in ASC 815-40, Contracts in Entity’s Own Equity. We classify as assets or liabilities any contracts that require
net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside our control)
or give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement). We assess
classification of our common stock purchase warrants and other freestanding derivatives at each reporting date to determine whether a
change in classification between assets and liabilities is required.
|
Net Income (Loss) per Share |
Net
Income (Loss) per Share
The
Company accounts for and discloses net income (loss) per common share in accordance with FASB ASC Topic 260, Earnings Per Share.
Basic income (loss) per common share is computed by dividing income (loss) attributable to common stockholders by the weighted average
number of common shares outstanding. Diluted net income (loss) per common share is computed by dividing net income (loss) attributable
to common stockholders by the weighted average number of common shares that would have been outstanding during the period assuming the
issuance of common stock for all potential dilutive common shares outstanding. Potential common shares consist of shares issuable upon
the exercise of stock options and warrants and the conversion of convertible notes payable.
The
following table sets forth the number of potential common shares excluded from the calculations of net loss per diluted share because
their inclusion would be anti-dilutive (in thousands):
Schedule of Anti-dilutive Securities Excluded from Calculations of Net Loss Per Share
| |
2024 | | |
2023 | |
| |
June 30, | |
| |
2024 | | |
2023 | |
Outstanding options to purchase common stock | |
| 555 | | |
| 350 | |
Warrants to purchase common stock | |
| - | | |
| 13 | |
Total | |
| 555 | | |
| 363 | |
|
Recent Accounting Pronouncements |
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.
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v3.24.2.u1
Basis of Presentation and Significant Accounting Policies (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Schedule of Anti-dilutive Securities Excluded from Calculations of Net Loss Per Share |
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
| |
2024 | | |
2023 | |
| |
June 30, | |
| |
2024 | | |
2023 | |
Outstanding options to purchase common stock | |
| 555 | | |
| 350 | |
Warrants to purchase common stock | |
| - | | |
| 13 | |
Total | |
| 555 | | |
| 363 | |
|
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v3.24.2.u1
Property and Equipment (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Property, Plant and Equipment [Abstract] |
|
Schedule of Property and Equipment |
Property
and equipment are recorded at cost and depreciated over the estimated useful lives of the underlying assets (three to five years) using
the straight-line method. As of June 30, 2024, and December 31, 2023, property and equipment consists of (table in thousands):
Schedule of Property and Equipment
| |
June 30, 2024 | | |
December 31, 2023 | |
Lab equipment (excluding equipment under finance leases) | |
$ | 1,765 | | |
$ | 1,757 | |
Finance lease right-of-use lab equipment obtained in exchange for finance lease liabilities, net | |
| 162 | | |
| 162 | |
Computer and office equipment | |
| 155 | | |
| 155 | |
Total property and equipment | |
| 2,082 | | |
| 2,074 | |
Less: accumulated depreciation and amortization | |
| (1,871 | ) | |
| (1,803 | ) |
Property and equipment, net | |
$ | 211 | | |
$ | 271 | |
|
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v3.24.2.u1
Accounts Payable and Accrued Expenses (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
Schedule of 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
| |
June 30, 2024 | | |
December 31, 2023 | |
Accounts payable | |
$ | 1,743 | | |
$ | 1,222 | |
Accrued compensation | |
| 156 | | |
| 109 | |
Accrued other expenses | |
| 504 | | |
| 1,691 | |
Total accounts payable and accrued expenses | |
$ | 2,403 | | |
$ | 3,022 | |
|
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v3.24.2.u1
Stock Based Awards (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Stock Option Transactions |
The
following table summarizes stock option transactions for the 2015 Plan, collectively, for the six months ended June 30, 2024 (in thousands,
except per share amounts):
Schedule of Stock Option Transactions
| |
Number of Shares Available for Grant | | |
Total Options Outstanding | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
Balance at December 31, 2023 | |
| 275 | | |
| 558 | | |
$ | 10.57 | | |
$ | - | |
Exercised | |
| - | | |
| - | | |
| - | | |
| - | |
Granted | |
| - | | |
| - | | |
| - | | |
| - | |
Expired | |
| 3 | | |
| (3 | ) | |
| 4.90 | | |
| - | |
Balance at June 30, 2024 | |
| 278 | | |
| 555 | | |
$ | 10.40 | | |
$ | - | |
|
Schedule of Common Stock Reserved for Future Issuance |
The
following table presents information concerning common stock available for future issuance (in thousands) as of:
Schedule of Common Stock Reserved for Future Issuance
| |
June 30, 2024 | | |
June 30, 2023 | |
Stock options issued and outstanding | |
| 555 | | |
| 350 | |
Shares authorized for future option grants | |
| 278 | | |
| 484 | |
Warrants outstanding | |
| - | | |
| 13 | |
Total | |
| 833 | | |
| 847 | |
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v3.24.2.u1
Warrants (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Warrants |
|
Schedule of Warrants Activity |
The
following is a summary of activity in the number of warrants classified as liabilities outstanding to purchase the Company’s common
stock for the six months ended June 30, 2024 (in thousands):
Schedule
of Warrants Activity
| |
January 2014 Warrants | |
Outstanding, December 31, 2023 | |
| 11 | |
Exercised | |
| - | |
Granted | |
| - | |
Expired | |
| (11 | ) |
Outstanding, June 30, 2024 | |
| - | |
Expiration date: | |
| 1/16/2024 | |
|
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v3.24.2.u1
Commitments and Contingencies (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Schedule of Maturities of Operating Lease Liabilities |
The
following table summarizes the Company’s maturities of operating lease liabilities, by year and in aggregate, as of June 30, 2024
(table in thousands):
Schedule
of Maturities of Operating Lease Liabilities
| |
| | |
2024 (excluding the six months ended June 30, 2024) | |
$ | 178 | |
2025 | |
| 344 | |
2026 | |
| 355 | |
2027 | |
| 365 | |
2028 | |
| 376 | |
2029 and thereafter | |
| 513 | |
Total operating lease payments | |
| 2,131 | |
Less: present value discount | |
| (351 | ) |
Total operating lease liabilities | |
$ | 1,780 | |
|
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v3.24.2.u1
Organization and Business (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
|
|
|
|
|
|
Net income loss |
$ 5,343,000
|
$ 3,956,000
|
$ 4,166,000
|
$ 5,189,000
|
$ 9,299,000
|
$ 9,355,000
|
|
Net cash provided by used in operating activities |
|
|
|
|
8,202,000
|
$ 8,659,000
|
|
Cash |
$ 18,143,000
|
|
|
|
$ 18,143,000
|
|
$ 26,353,000
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v3.24.2.u1
Basis of Presentation and Significant Accounting Policies (Details Narrative)
|
6 Months Ended |
|
Jun. 30, 2024
USD ($)
Segment
|
Dec. 31, 2023
USD ($)
|
Accounting Policies [Abstract] |
|
|
Number of operating segments | Segment |
1
|
|
Cash FDIC insured amount |
$ 250,000
|
|
Cash |
7,536,000
|
$ 16,322,000
|
Collateral account balance |
75,000
|
75,000
|
Refundable tax credit receivable |
1,050,000
|
$ 786,000
|
Refundable tax credits accrued |
264,000
|
|
Income tax expense |
$ 0
|
|
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v3.24.2.u1
Schedule of Property and Equipment (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
$ 2,082
|
$ 2,074
|
Less: accumulated depreciation and amortization |
(1,871)
|
(1,803)
|
Property and equipment, net |
211
|
271
|
Lab Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
1,765
|
1,757
|
Finance Lease Right-of-use Lab Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
162
|
162
|
Computer and Office Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
$ 155
|
$ 155
|
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Property and Equipment (Details Narrative) - USD ($)
|
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Property, Plant and Equipment [Line Items] |
|
|
Depreciation and amortization expense |
$ 68,000
|
$ 96,000
|
Finance Lease Right-of-use Lab Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Amortization expense |
$ 0
|
$ 7,164
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|
|
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|
|
Property and equipment, estimated useful lives |
3 years
|
|
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|
|
Property, Plant and Equipment [Line Items] |
|
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5 years
|
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v3.24.2.u1
Common Stock and Preferred Stock (Details Narrative) - $ / shares
|
6 Months Ended |
|
|
Jun. 30, 2024 |
Jun. 27, 2024 |
Dec. 31, 2023 |
Equity [Abstract] |
|
|
|
Common stock, shares authorized |
100,000,000
|
150,000,000
|
150,000,000
|
Common stock, par value |
$ 0.001
|
|
$ 0.001
|
Preferred stock, shares authorized |
1,000,000
|
5,000,000
|
|
Preferred stock, par value |
$ 0.001
|
|
|
Capital stock, shares authorized |
101,000,000
|
155,000,000
|
|
Common stock, shares issued |
10,174,000
|
|
10,174,000
|
Common stock, shares outstanding |
10,174,000
|
|
10,174,000
|
Preferred stock, shares issued |
0
|
|
0
|
Preferred stock, shares outstanding |
0
|
|
0
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The
holders of common stock are entitled to one vote for each share of common stock held.
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v3.24.2.u1
Schedule of Stock Option Transactions (Details) shares in Thousands |
6 Months Ended |
Jun. 30, 2024
USD ($)
$ / shares
shares
|
Option Indexed to Issuer's Equity [Line Items] |
|
Number of Shares Available for Grant, Ending balance |
278
|
Total Options Outstanding, Ending balance |
555
|
Share-Based Payment Arrangement, Option [Member] |
|
Option Indexed to Issuer's Equity [Line Items] |
|
Number of Shares Available for Grant, Beginning balance |
275
|
Total Options Outstanding, Beginning balance |
558
|
Weighted Average Exercise Price Outstanding, Beginning balance | $ / shares |
$ 10.57
|
Aggregate Intrinsic Value, Beginning balance | $ |
|
Number of Shares Available for Grant, Exercised |
|
Total Options Outstanding, Exercised |
|
Weighted Average Exercise Price, Exercised | $ / shares |
|
Aggregate Intrinsic Value, Exercised | $ |
|
Number of Shares Available for Grant, Granted |
|
Total Options Outstanding, Granted |
|
Weighted Average Exercise Price, Granted | $ / shares |
|
Aggregate Intrinsic Value, Granted | $ / shares |
|
Number of Shares Available for Grant, Expired |
3
|
Total Options Outstanding, Expired |
(3)
|
Weighted Average Exercise Price, Expired | $ / shares |
$ 4.90
|
Aggregate Intrinsic Value, Expired | $ |
|
Number of Shares Available for Grant, Ending balance |
278
|
Total Options Outstanding, Ending balance |
555
|
Weighted Average Exercise Price, Ending balance | $ / shares |
$ 10.40
|
Aggregate Intrinsic Value, Ending balance | $ |
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Stock Based Awards (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 16, 2021 |
Jun. 15, 2021 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Shares reserved for issuance |
833,000
|
847,000
|
833,000
|
847,000
|
|
|
Shares available for grant |
278,000
|
484,000
|
278,000
|
484,000
|
|
|
Equity-based compensation expense |
$ 148,000
|
$ 179,000
|
$ 305,000
|
$ 241,000
|
|
|
Unrecognized compensation expense |
$ 402,000
|
|
$ 402,000
|
|
|
|
Unrecognized compensation expense, weighted average period |
|
|
10 months 24 days
|
|
|
|
Options vested or expected to vest, outstanding shares |
555,000
|
|
555,000
|
|
|
|
Options vested or expected to vest, aggregate intrinsic value |
$ 0
|
|
$ 0
|
|
|
|
Options vested or expected to vest, weighted average exercise price |
$ 10.40
|
|
$ 10.40
|
|
|
|
Options vested or expected to vest, weighted average remaining contractual term |
|
|
7 years 8 months 12 days
|
|
|
|
Options vested and exercisable, outstanding shares |
307,000
|
|
307,000
|
|
|
|
Options vested and exercisable, aggregate intrinsic value |
$ 0
|
|
$ 0
|
|
|
|
Options vested and exercisable, weighted-average exercise price |
$ 16.33
|
|
$ 16.33
|
|
|
|
Options vested and exercisable, weighted average remaining contractual term |
|
|
6 years 9 months 18 days
|
|
|
|
Common stock closing price per share |
$ 2.33
|
|
$ 2.33
|
|
|
|
2015 Equity Incentive Plan [Member] |
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Shares reserved for issuance |
833,333
|
|
833,333
|
|
|
|
Maximum term of options granted |
|
|
10 years
|
|
|
|
Common stock authorized for issuance |
|
|
|
|
833,333
|
416,667
|
Shares available for grant |
278,000
|
|
278,000
|
|
|
|
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v3.24.2.u1
Commitments and Contingencies (Details Narrative)
|
|
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
12 Months Ended |
|
|
|
Sep. 21, 2023
USD ($)
ft²
|
Sep. 01, 2021
USD ($)
|
Apr. 30, 2020
USD ($)
|
Jun. 30, 2024
USD ($)
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2024
USD ($)
|
Jun. 30, 2023
USD ($)
|
Dec. 31, 2023
USD ($)
|
May 21, 2024
USD ($)
|
Mar. 31, 2023
USD ($)
|
Aug. 03, 2022
USD ($)
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Operating lease, weighted average discount rate |
|
|
|
6.00%
|
|
6.00%
|
|
|
|
|
|
Operating lease, weighted average remaining lease term |
|
|
|
5 years 10 months 24 days
|
|
5 years 10 months 24 days
|
|
|
|
|
|
Current operating lease liability |
|
|
|
$ 251,000
|
|
$ 251,000
|
|
$ 240,000
|
|
|
|
Operating lease expense |
|
|
|
|
|
189,000
|
$ 116,000
|
|
|
|
|
Clinical trial expenses |
|
|
|
4,308,000
|
$ 2,801,000
|
7,258,000
|
6,708,000
|
|
|
|
|
Lab Equipment [Member] |
|
|
|
|
|
|
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Estimated useful life |
|
|
|
|
|
|
|
|
|
25 months
|
|
Fixed assets book value |
|
|
|
|
|
|
|
|
|
$ 32,000
|
|
Related Party [Member] |
|
|
|
|
|
|
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Operating lease expense |
|
|
|
|
|
31,000
|
26,000
|
|
|
|
|
Lease Agreement [Member] | Lab Equipment [Member] |
|
|
|
|
|
|
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Lease expiration date |
|
|
Mar. 31, 2023
|
|
|
|
|
|
|
|
|
Finance lease term |
|
|
36 months
|
|
|
|
|
|
|
|
|
Payments for rent |
|
|
$ 2,000
|
|
|
|
|
|
|
|
|
Estimated useful life |
|
|
5 years
|
|
|
|
|
|
|
|
|
Right-of-use asset obtained in exchange for finance lease liability |
|
|
|
|
|
|
|
162,000
|
|
|
|
Finance lease, accumulated depreciation |
|
|
|
|
|
|
|
$ 162,000
|
|
|
|
Phase 2a Clinical Trial [Member] |
|
|
|
|
|
|
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Prepaid reservation fee |
|
|
|
|
|
|
|
|
|
|
$ 1,700,000
|
Clinical trial expenses |
|
|
|
|
|
1,700,000
|
|
|
|
|
|
Prepaid and other expenses |
|
|
|
0
|
|
0
|
|
|
|
|
|
Additional costs |
|
|
|
|
|
1,700,000
|
|
|
|
|
|
Estimated agreement cost |
|
|
|
6,900,000
|
|
6,900,000
|
|
|
|
|
|
Agreement [Member] | hVIVO [Member] |
|
|
|
|
|
|
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Additional costs |
|
|
|
$ 45,000
|
|
|
|
|
|
|
|
Estimated agreement cost |
|
|
|
|
|
|
|
|
$ 227,000
|
|
|
Dr. Phillip Frost [Member] |
|
|
|
|
|
|
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Rent expense |
|
$ 62,000
|
|
|
|
|
|
|
|
|
|
Payments for rent |
|
|
|
|
|
31,000
|
31,000
|
|
|
|
|
North Creek Tec LLC [Member] |
|
|
|
|
|
|
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Operating lease payments |
$ 380,000
|
|
|
|
|
|
|
|
|
|
|
North Creek Tec LLC [Member] | Amended Lease Agreement for Expansion [Member] |
|
|
|
|
|
|
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Lease expiration date |
Jan. 31, 2029
|
|
|
|
|
|
|
|
|
|
|
Land subject to leases | ft² |
6,000
|
|
|
|
|
|
|
|
|
|
|
Operating lease term |
5 years
|
|
|
|
|
|
|
|
|
|
|
Operating lease payments |
$ 660,000
|
|
|
|
|
|
|
|
|
|
|
North Creek Tec LLC [Member] | Amended Lease Agreement for Extension [Member] |
|
|
|
|
|
|
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Operating lease term |
7 years
|
|
|
|
|
|
|
|
|
|
|
Operating lease payments |
$ 1,498,000
|
|
|
|
|
|
|
|
|
|
|
Lease expiration period |
January 2031
|
|
|
|
|
|
|
|
|
|
|
General and Administrative Expense [Member] |
|
|
|
|
|
|
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Common area maintenance charges |
|
|
|
|
|
$ 95,000
|
$ 54,000
|
|
|
|
|
Miami, Florida [Member] |
|
|
|
|
|
|
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Lease expiration date |
|
|
|
|
|
Aug. 31, 2024
|
|
|
|
|
|
Bothell, Washington [Member] |
|
|
|
|
|
|
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Lease expiration date |
|
|
|
|
|
Jan. 31, 2029
|
|
|
|
|
|
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v3.24.2.u1
Transactions with Related Parties (Details Narrative) - USD ($)
|
|
|
6 Months Ended |
Apr. 04, 2023 |
Sep. 01, 2021 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Securities Purchase Agreement [Member] |
|
|
|
|
Unregistered common stock, shares |
2,030,458
|
|
|
|
Unregistered common stock, share price |
$ 1.97
|
|
|
|
Unregistered common stock, purchase price |
$ 4,000,000
|
|
|
|
Unregistered common stock, investments |
$ 2,000,000
|
|
|
|
Dr. Phillip Frost [Member] |
|
|
|
|
Lease extension description |
|
three-year lease extension
|
|
|
Rent expenses |
|
|
$ 31,000
|
$ 31,000
|
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Cocrystal Pharma (NASDAQ:COCP)
Gráfica de Acción Histórica
De Jul 2024 a Ago 2024
Cocrystal Pharma (NASDAQ:COCP)
Gráfica de Acción Histórica
De Ago 2023 a Ago 2024