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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, 2023
OR
☐ |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the transition period from to
Commission
file number: 001-38418
COCRYSTAL
PHARMA, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
35-2528215 |
(State
or Other Jurisdiction of |
|
(I.R.S.
Employer |
Incorporation
or Organization) |
|
Identification
No.) |
19805
North Creek Parkway Bothell, WA |
|
98011 |
(Address
of Principal Executive Office) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: 877-262-7123
Indicate
by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (Sec.232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was
required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):
Large
accelerated filer |
☐ |
Accelerated
filer |
☐ |
|
|
|
|
Non-accelerated
filer |
☒ |
Smaller
reporting company |
☒ |
|
|
|
|
Emerging
growth company |
☐ |
|
|
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
Securities
registered pursuant to Section 12(b) of the Act:
Title
of Each Class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock |
|
COCP |
|
The
Nasdaq Stock Market LLC
(The
Nasdaq Capital Market) |
As
of August 14, 2023, the number of outstanding shares of the registrant’s common stock, par value $0.001 per share, was approximately
10,173,790.
COCRYSTAL
PHARMA, INC.
FORM
10-Q FOR THE QUARTER ENDED JUNE 30, 2023
INDEX
Part
I – FINANCIAL INFORMATION
COCRYSTAL
PHARMA, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands, except per share data)
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
(unaudited) | | |
| |
Assets | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash | |
$ | 32,419 | | |
$ | 37,144 | |
Restricted cash | |
| 75 | | |
| 75 | |
Tax credit receivable | |
| 1,207 | | |
| 716 | |
Prepaid expenses and other current assets | |
| 2,060 | | |
| 2,243 | |
Total current assets | |
| 35,761 | | |
| 40,178 | |
Property and equipment, net | |
| 305 | | |
| 342 | |
Deposits | |
| 46 | | |
| 46 | |
Operating lease right-of-use assets, net (including $72 and $99 respectively, to related party) | |
| 167 | | |
| 274 | |
Total assets | |
$ | 36,279 | | |
$ | 40,840 | |
| |
| | | |
| | |
Liabilities and stockholders’ equity | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable and accrued expenses | |
$ | 1,421 | | |
$ | 976 | |
Current maturities of finance lease liabilities | |
| - | | |
| 7 | |
Current maturities of operating lease liabilities (including $62 and $59 respectively, to related party) | |
| 166 | | |
| 233 | |
Total current liabilities | |
| 1,587 | | |
| 1,216 | |
Long-term liabilities: | |
| | | |
| | |
| |
| | | |
| | |
Operating lease liabilities (including $10 and $42 respectively, to related party) | |
| 10 | | |
| 57 | |
| |
| | | |
| | |
Total liabilities | |
| 1,597 | | |
| 1,273 | |
| |
| | | |
| | |
Commitments and contingencies | |
| - | | |
| - | |
| |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Common stock, $0.001 par value; 150,000 shares authorized as of June 30, 2023, and December 31, 2022; 10,174 and 8,143 shares issued and outstanding as of June 30, 2023 and December 31, 2022 | |
| 10 | | |
| 8 | |
Additional paid-in capital | |
| 341,957 | | |
| 337,489 | |
Accumulated deficit | |
| (307,285 | ) | |
| (297,930 | ) |
Total stockholders’ equity | |
| 34,682 | | |
| 39,567 | |
Total liabilities and stockholders’ equity | |
$ | 36,279 | | |
$ | 40,840 | |
See
accompanying notes to condensed consolidated financial statements.
COCRYSTAL
PHARMA, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in
thousands, except per share data)
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three months ended June 30, | | |
Six months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 2,801 | | |
| 2,361 | | |
| 6,708 | | |
| 5,233 | |
General and administrative | |
| 1,538 | | |
| 1,375 | | |
| 2,742 | | |
| 2,708 | |
Legal settlement | |
| - | | |
| 1,600 | | |
| - | | |
| 1,600 | |
Impairments | |
| - | | |
| 19,092 | | |
| - | | |
| 19,092 | |
Total operating expenses | |
| 4,339 | | |
| 24,428 | | |
| 9,450 | | |
| 28,633 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (4,339 | ) | |
| (24,428 | ) | |
| (9,450 | ) | |
| (28,633 | ) |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Interest income (expense), net | |
| 140 | | |
| - | | |
| 140 | | |
| (1 | ) |
Foreign exchange loss | |
| 33 | | |
| (1 | ) | |
| (45 | ) | |
| (14 | ) |
Change in fair value of derivative liabilities | |
| - | | |
| 1 | | |
| - | | |
| 12 | |
Total other expense, net | |
| 173 | | |
| - | | |
| 95 | | |
| (3 | ) |
Net loss | |
$ | (4,166 | ) | |
$ | (24,428 | ) | |
| (9,355 | ) | |
| (28,636 | ) |
Net loss per common share, basic and diluted | |
$ | (0.41 | ) | |
$ | (3.00 | ) | |
| (1.03 | ) | |
| (3.48 | ) |
Weighted average number of common shares outstanding, basic and diluted | |
| 10,065 | | |
| 8,143 | | |
| 9,109 | | |
| 8,143 | |
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, 2022 | |
| 8,143 | | |
$ | 8 | | |
$ | 337,489 | | |
$ | (297,930 | ) | |
$ | 39,567 | |
Stock-based compensation | |
| - | | |
| - | | |
| 291 | | |
| - | | |
| 291 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (5,189 | ) | |
| (5,189 | ) |
Balance as of March 31, 2023 | |
| 8,143 | | |
$ | 8 | | |
$ | 337,780 | | |
$ | (303,119 | ) | |
$ | 34,669 | |
Stock-based compensation | |
| - | | |
| - | | |
| 179 | | |
| - | | |
| 179 | |
Sale of common stock, 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 | |
| |
Common Stock | | |
Additional Paid-in | | |
Accumulated | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balance as of December 31, 2021 | |
| 8,143 | | |
$ | 8 | | |
$ | 336,544 | | |
$ | (259,093 | ) | |
$ | 77,549 | |
Stock-based compensation | |
| - | | |
| - | | |
| 239 | | |
| - | | |
| 239 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (4,208 | ) | |
| (4,208 | ) |
Balance as of March 31, 2022 | |
| 8,143 | | |
$ | 8 | | |
$ | 336,783 | | |
$ | (263,301 | ) | |
$ | 73,580 | |
Stock-based compensation | |
| - | | |
| - | | |
| 241 | | |
| - | | |
| 241 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (24,428 | ) | |
| (24,428 | ) |
Balance as of June 30, 2022 | |
| 8,143 | | |
$ | 8 | | |
$ | 337,024 | | |
$ | (287,729 | ) | |
$ | 49,393 | |
See
accompanying notes to condensed consolidated financial statements.
COCRYSTAL
PHARMA, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in
thousands)
| |
2023 | | |
2022 | |
| |
Six months ended June 30, | |
| |
2023 | | |
2022 | |
Operating activities: | |
| | | |
| | |
Net loss | |
$ | (9,355 | ) | |
$ | (28,636 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization expense | |
| 96 | | |
| 90 | |
Amortization of right of use assets | |
| 108 | | |
| 100 | |
Loss on impairment of goodwill | |
| - | | |
| 19,092 | |
Stock-based compensation | |
| 470 | | |
| 480 | |
Payments on operating lease liabilities | |
| (115 | ) | |
| (102 | ) |
Change in fair value of derivative liabilities | |
| - | | |
| (12 | ) |
Changes in operating assets and liabilities: | |
| | | |
| | |
Prepaid expenses and other current assets | |
| 183 | | |
| 80 | |
Tax credit receivable | |
| (491 | ) | |
| - | |
Accounts payable and accrued expenses | |
| 445 | | |
| (326 | ) |
Settlement payable | |
| - | | |
| 1,600 | |
Net cash used in operating activities | |
| (8,659 | ) | |
| (7,634 | ) |
| |
| | | |
| | |
Investing activities: | |
| | | |
| | |
Purchases of property and equipment | |
| (59 | ) | |
| - | |
Net cash used in investing activities | |
| (59 | ) | |
| - | |
| |
| | | |
| | |
Financing activities: | |
| | | |
| | |
Payments on finance lease liabilities | |
| (7 | ) | |
| (13 | ) |
Proceeds from sale of common stock, net of transaction costs | |
| 4,000 | | |
| - | |
Net cash provided by (used in) financing activities | |
| 3,993 | | |
| (13 | ) |
| |
| | | |
| | |
Net decrease in cash and restricted cash | |
| (4,725 | ) | |
| (7,647 | ) |
Cash and restricted cash at beginning of period | |
| 37,219 | | |
| 58,755 | |
Cash and restricted cash at end of period | |
$ | 32,494 | | |
$ | 51,108 | |
See
accompanying notes to condensed consolidated financial statements.
COCRYSTAL
PHARMA, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
1.
Organization and Business
Cocrystal
Pharma, Inc. (“we”, the “Company” or “Cocrystal”), a clinical stage biopharmaceutical company incorporated
in Delaware, has been developing novel technologies and approaches to create first-in-class or best-in-class antiviral drug candidates
since its initial funding in 2008. 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, 2023, the Company has primarily funded its operations through equity offerings.
In
September 2021, the Company opened a wholly owned foreign subsidiary in Australia named Cocrystal Pharma Australia, Ltd (“Cocrystal
Australia”) with the objective of operating clinical trials in Australia.
On
September 27, 2022, the Company filed a Certificate of Amendment to the Certificate of Incorporation (the “Amendment”) with
the Delaware Secretary of State to effect a reverse stock split of all outstanding shares of the Company’s common stock at a ratio
of one-for-12. At the Company’s 2022 Annual Meeting of Stockholders, holders of a majority of the outstanding voting power approved
an amendment to the Certificate of Incorporation of the Company to effect a reverse stock split of all outstanding shares of our common
stock at a ratio to be determined by the Board of Directors within a range of one-for-four through one-for-12. Following such approval,
the Board of Directors determined to effect the reverse stock split at the ratio of one-for-12. The Amendment became effective October
11, 2022 and the effect of the reverse stock split was reflected on the Nasdaq Stock Market.
All
share and per share amounts have been retroactively restated to reflect the one-for-12 stock split
as if it occurred at the beginning of the earliest period presented.
2.
Basis of Presentation and Significant Accounting Policies
Basis
of Presentation
The
accompanying condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting
principles (“U.S. GAAP”) for interim financial information, the instructions to Form 10-Q and Article 10 of Regulation S-X
set forth by the Securities and Exchange Commission (“SEC”). They do not include all of the information and notes required
by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals)
considered necessary for a fair presentation have been included. The results of operations for the interim periods presented are not
necessarily indicative of the results of operations for the entire fiscal year. For further information, refer to the consolidated financial
statements and footnotes thereto included in the Company’s annual report on Form 10-K for the year ended December 31, 2022 filed
on March 29, 2023 (“Annual Report”).
Principles
of Consolidation
The
consolidated financial statements include the accounts of Cocrystal Pharma, Inc. and its wholly owned subsidiaries: Cocrystal Discovery,
Inc., Cocrystal Pharma Australia Pty Ltd., RFS Pharma, LLC and Cocrystal Merger Sub, Inc. Intercompany transactions and balances have
been eliminated.
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 derivative liabilities, recoverability
of deferred tax assets, 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, 2023 and December 31, 2022, our primary operating accounts held approximately $32,419,000 and $37,144,000,
respectively, and our collateral account balance was $75,000 and $75,000 at a different institution. The Company has not experienced
any losses in such accounts and believes it is not exposed to significant risks thereof.
Foreign
Currency Transactions
The
Company and its subsidiaries use the U.S. dollar as functional currency. Foreign currency transactions are initially measured and recorded
in the functional currency using the exchange rate on the date of the transaction. Foreign exchange gains and losses arising from settlement
of foreign currency transactions are recognized in profit and loss.
Cocrystal
Australia maintains its records in Australian dollars. The monetary assets and liabilities of Cocrystal Australia are remeasured into
the functional currency using the closing rate at the end of every reporting period. All nonmonetary assets and liabilities and related
profit and loss accounts are remeasured into the functional currency using the historical exchange rates. Profit and loss accounts, other
than those that are remeasured using the historical exchange rates, are remeasured into the functional currency using the average exchange
rate for the period. Foreign exchange gains and losses arising from the remeasurement into the functional currency is recognized in profit
and loss.
Fair
Value Measurements
FASB
Accounting Standards Codification (“ASC”) 820 defines fair value, establishes a framework for measuring fair value under
U.S. GAAP and enhances disclosures about fair value measurements. Fair value is defined under ASC 820 as the exchange price that would
be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or
liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value
under ASC 820 must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes a fair value
hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used
to measure fair value which are the following:
|
Level
1 — quoted prices in active markets for identical assets or liabilities. |
|
|
|
Level
2 — other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement
date. |
|
|
|
Level
3 — significant unobservable inputs that reflect management’s best estimate of what market participants would use to
price the assets or liabilities at the measurement date. |
The
Company categorizes its cash and restricted cash as Level 1 fair value measurements. The Company categorizes its warrants potentially
settleable in cash as Level 2 fair value measurements. The warrants potentially settleable in cash are measured at fair value on a recurring
basis and are being marked to fair value at each reporting date until they are completely settled or meet the requirements to be accounted
for as component of stockholders’ equity. The warrants are valued using the Black-Scholes option pricing model as discussed in
Note 7 – Warrants.
At
June 30, 2023 and December 31, 2022, the carrying amounts of financial assets and liabilities, such as cash, accounts receivable, other
assets, and accounts payable and accrued expenses approximate their fair values due to their short-term nature. The carrying values of
leases payable approximate their fair values due to the fact that the interest rates on these obligations are based on prevailing market
interest rates.
The
Company’s derivative liabilities are considered Level 3 measurements.
Long-Lived
Assets
The
Company regularly reviews the carrying value and estimated lives of its long-lived assets, including property and equipment, to determine
whether indicators of impairment may exist which warrant adjustments to carrying values or estimated useful lives. The determinants used
for this evaluation include management’s estimate of the asset’s ability to generate positive income from operations and
positive cash flow in future periods as well as the strategic significance of the assets to the Company’s business objective. Should
an impairment exist, the impairment loss would be measured based on the excess of the carrying amount over the asset’s fair value.
Research
and Development Expenses
Research
and development costs consist primarily of fees paid to consultants and outside service providers, and other expenses relating to the
acquisition, design, development and testing of the Company’s clinical products. All
research and development costs are expensed as incurred. Research and development costs are presented net of tax credits.
The
Company’s Australian subsidiary is entitled to receive government assistance in the form of refundable and non-refundable research
and development tax credits from the federal and provincial taxation authorities, based on qualifying expenditures incurred during the
fiscal year. The refundable credits are from the provincial taxation authorities and are not dependent on its ongoing tax status or tax
position and accordingly are not considered part of income taxes. The Company records refundable tax credits as a reduction of research
and development expenses when the Company can reasonably estimate the amounts and it is more likely than not, they will be received.
During the year ended December 31, 2022, the Company recorded tax
credits of $805,000 as a reduction of research and development expense, of which approximately
$716,000 was recorded as tax credit receivable as of the year then ended. The Company recorded an accrued tax credit receivable of $491,000
for the six months ended June 30, 2023, resulting in a tax credit receivable of $1,207,000 at June 30, 2023.
Income
Taxes
The
Company accounts for income taxes under the asset and liability method. Under this method, deferred tax assets and liabilities are determined
based on differences between financial reporting and tax bases of assets and liabilities and are measured using enacted tax rates and
laws that are expected to be in effect when the differences are expected to be recovered or settled. Realization of deferred tax assets
is dependent upon future taxable income. A valuation allowance is recognized if it is more likely than not that some portion or all of
a deferred tax asset will not be realized based on the weight of available evidence, including expected future earnings. The Company
recognizes an uncertain tax position in its financial statements when it concludes that a tax position is more likely than not to be
sustained upon examination based solely on its technical merits. Only after a tax position passes the first step of recognition will
measurement be required. Under the measurement step, the tax benefit is measured as the largest amount of benefit that is more likely
than not to be realized upon effective settlement. This is determined on a cumulative probability basis. The full impact of any change
in recognition or measurement is reflected in the period in which such change occurs. The Company elects to accrue any interest or penalties
related to income taxes as part of its income tax expense.
As
of June 30, 2023, the Company assessed its income tax expense based on its projected future taxable income for the year ending December
31, 2023 and therefore recorded no amount for income tax expense for the six months ended June 30, 2023. In addition, the Company has
significant deferred tax assets available to offset income tax expense due to net operating loss carry forwards which are currently subject
to a full valuation allowance based on the Company’s assessment of future taxable income. Refer to our Annual Report on Form 10-K
for the year ended December 31, 2022 for more information.
Stock-Based
Compensation
The
Company recognizes compensation expense using a fair value-based method for costs related to stock-based payments, including stock options.
The fair value of options awarded to employees is measured on the date of grant using the Black-Scholes option pricing model and is recognized
as expense over the requisite service period on a straight-line basis.
Use
of the Black-Scholes option pricing model requires the input of subjective assumptions including expected volatility, expected term,
and a risk-free interest rate. The Company estimates volatility using a blend of its own historical stock price volatility as well as
that of market comparable entities since the Company’s common stock has limited trading history and limited observable volatility
of its own. The expected term of the options is estimated by using the SEC Staff Bulletin No. 107’s Simplified Method for Estimate
Expected Term. The risk-free interest rate is estimated using comparable published federal funds rates.
Common
Stock Purchase Warrants and Other Derivative Financial Instruments
We
classify as equity any contracts that require physical settlement or net-share settlement or provide us a choice of net-cash settlement
or settlement in our own shares (physical settlement or net-share settlement) provided that such contracts are indexed to our own stock
as defined in ASC 815-40, Contracts in Entity’s Own Equity. We classify as assets or liabilities any contracts that require
net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside our control)
or give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement). We assess
classification of our common stock purchase warrants and other freestanding derivatives at each reporting date to determine whether a
change in classification between assets and liabilities is required.
Net
Income (Loss) per Share
The
Company accounts for and discloses net income (loss) per common share in accordance with FASB ASC Topic 260, Earnings Per Share.
Basic income (loss) per common share is computed by dividing income (loss) attributable to common stockholders by the weighted average
number of common shares outstanding. Diluted net income (loss) per common share is computed by dividing net income (loss) attributable
to common stockholders by the weighted average number of common shares that would have been outstanding during the period assuming the
issuance of common stock for all potential dilutive common shares outstanding. Potential common shares consist of shares issuable upon
the exercise of stock options and warrants and the conversion of convertible notes payable.
The
following table sets forth the number of potential common shares excluded from the calculations of net loss per diluted share because
their inclusion would be anti-dilutive (in thousands):
Schedule
of Antidilutive Securities Excluded from Calculations of Net Loss Per Share
| |
2023 | | |
2022 | |
| |
June 30, | |
| |
2023 | | |
2022 | |
Outstanding options to purchase common stock | |
| 350 | | |
| 2,340 | |
Warrants to purchase common stock | |
| 13 | | |
| 243 | |
Total | |
| 363 | | |
| 2,583 | |
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, 2023, and December 31, 2022, property and equipment consists of (in thousands):
Schedule
of Property and Equipment
| |
June 30, 2023 | | |
December 31, 2022 | |
Lab equipment | |
$ | 1,708 | | |
$ | 1,631 | |
Finance lease right-of-use lab equipment | |
| 162 | | |
| 194 | |
Computer and office equipment | |
| 145 | | |
| 131 | |
Total property and equipment | |
| 2,015 | | |
| 1,956 | |
Less: accumulated depreciation and amortization | |
| (1,710 | ) | |
| (1,614 | ) |
Property and equipment, net | |
$ | 305 | | |
$ | 342 | |
Total
depreciation and amortization expense were approximately $96,000 and $90,000 for the six months
ended June 30, 2023 and 2022, which includes amortization expense of $7,164 and $7,716 for the six months ended June 30, 2023 and 2022,
respectively, related to assets under finance lease. For additional finance leases information, refer to Note 9 – Commitments and
Contingencies.
4.
Accounts Payable and Accrued Expenses
Accounts
payable and accrued expenses consisted of the following (in thousands) as of:
Schedule
of Accounts Payable and Accrued Expenses
| |
June 30, 2023 | | |
December 31, 2022 | |
Accounts payable | |
$ | 1,041 | | |
$ | 614 | |
Accrued compensation | |
| 150 | | |
| 130 | |
Accrued other expenses | |
| 230 | | |
| 232 | |
Total accounts payable and accrued expenses | |
$ | 1,421 | | |
$ | 976 | |
Accounts
payable and accrued other expenses contain unpaid general and administrative expenses and costs related to research and development that
have been billed and estimated unbilled, respectively, as of period-end.
5.
Common Stock
The
Company has 150,000,000 shares of common stock, $0.001 par value per share, authorized as of June 30, 2023, and December 31, 2022. The
Company had 10,174 and 8,143 shares issued and outstanding as of June 30, 2023, and December 31, 2022. The holders of common stock are
entitled to one vote for each share of common stock held.
On
April 4, 2023, the Company entered into a Securities Purchase Agreement with two accredited investors (the “Purchasers”)
pursuant to which the Purchasers purchased a total of 2,030,458 shares of common stock at a price of $1.97 per share for a total purchase
price of $4,000,000 in two equal $2,000,000 investments in an unregistered offering
exempt from registration pursuant to Section 4(a)(2) of the Securities Act of 1933 and Rule 506(b) promulgated thereunder.
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 nonemployee 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, 2023, 483,815 shares remain available
for future grants under the 2015 Plan.
In
July 2022, the Compensation Committee of the Company’s Board of Directors granted a total of 158,012 stock options with a fair
value of $633,000 effective as of July 26, 2022. The Company granted the stock options to directors, executives, employees, and consultants.
The options are ten-year incentive stock options exercisable at $0.42 per share and vesting as follows: one-half vested on the one-year
anniversary of the grant date and the remainder vest in eight equal quarterly instalments on the last day of March, June, September and
December, with the first such quarterly instalment having vested on June 30, 2023.
The
following table summarizes stock option transactions for the 2015 Plan, collectively, for the six months ended June 30, 2023 (in thousands,
except per share amounts):
Schedule of Share-based Compensation, Stock Options, Activity
| |
Number of Shares Available for Grant | | |
Total Options Outstanding | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
Balance at December 31, 2022 | |
| 484 | | |
| 350 | | |
$ | 15.03 | | |
$ | 0.00 | |
Increase in authorized options | |
| - | | |
| - | | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | | |
| - | | |
| - | |
Granted | |
| - | | |
| - | | |
| - | | |
| - | |
Expired | |
| - | | |
| - | | |
| - | | |
| - | |
Cancelled | |
| - | | |
| - | | |
| - | | |
| - | |
Balance at June 30, 2023 | |
| 484 | | |
| 350 | | |
$ | 14.98 | | |
$ | 0.00 | |
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. During the period ended June 30, 2023, the Company did not grant any stock options. For the
three and six months ended June 30, 2023 and 2022, equity-based compensation expense recorded was $179,000 and $470,000 and $241,000 and
$480,000 respectively.
The
fair value of share option award is estimated using the Black-Scholes option pricing method based on the following weighted-average assumptions:
Schedule of Share-based Compensation, Stock Options, Assumption
| |
2023 | | |
2022 | |
| |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Risk-Free interest rate | |
| 1.64 | % | |
| 1.04 | % |
Expected dividend yield | |
| 0.00 | % | |
| 0.00 | % |
Expected volatility | |
| 87.82 | % | |
| 76.24 | % |
Expected term (in years) | |
| 4.81 | | |
| 4.33 | |
As
of June 30, 2023, there was approximately $582,000 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 350,000 options
outstanding which were fully vested or expected to vest, with an aggregate intrinsic value of $0.00, a weighted average exercise price
of $14.98 and weighted average remaining contractual term of 7.9 years at June 30, 2023. For vested and exercisable options, outstanding
shares totaled 170,000, with an aggregate intrinsic value of $0.00. These options had a weighted average exercise price of $24.45 per
share and a weighted-average remaining contractual term of 6.8 years at June 30, 2023.
The
aggregate intrinsic value of outstanding and exercisable options at June 30, 2023 was calculated based on the closing price of the Company’s
common stock as reported on The Nasdaq Capital Market on June 30, 2023 of $2.39 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, 2023 | | |
June 30, 2022 | |
Stock options issued and outstanding | |
| 350 | | |
| 195 | |
Shares authorized for future option grants | |
| 484 | | |
| 639 | |
Warrants outstanding | |
| 13 | | |
| 20 | |
Total | |
| 847 | | |
| 10,253 | |
7.
Warrants
The
following is a summary of activity in the number of warrants outstanding to purchase the Company’s common stock for the six months
ended June 30, 2023 (in thousands):
Summary of Warrant Activity
| |
Warrants Accounted for as: Equity | | |
Warrants Accounted for as: Liabilities | | |
| |
| |
May 2018 Warrants | | |
October 2013 Warrants | | |
January 2014 Warrants | | |
Total | |
Outstanding, December 31, 2022 | |
| - | | |
| 2 | | |
| 11 | | |
| 13 | |
Exercised | |
| - | | |
| - | | |
| - | | |
| - | |
Granted | |
| - | | |
| - | | |
| - | | |
| - | |
Expired | |
| - | | |
| - | | |
| - | | |
| - | |
Outstanding, June 30, 2023 | |
| - | | |
| 2 | | |
| 11 | | |
| 13 | |
Expiration date: | |
| - | | |
| 10/24/2023 | | |
| 01/16/2024 | | |
| | |
Warrants
Classified as Liabilities
Liability-classified
warrants consist of warrants issued by Biozone Pharmaceuticals, Inc. (“Biozone”), the company’s predecessor, in connection
with an equity financing in October 2013 which were assumed by the Company in connection with its merger with Biozone in January 2014
and warrants issued by the Company in January 2014. Warrants accounted for as liabilities have the potential to be settled in cash or
are not indexed to the Company’s own stock.
The
estimated fair value of outstanding warrants accounted for as liabilities is determined at each balance sheet date. Any decrease or increase
in the estimated fair value of the warrant liability since the most recent balance sheet date is recorded in the condensed consolidated
statement of operations as changes in fair value of derivative liabilities.
The
fair value of the warrants classified as liabilities is estimated using the Black-Scholes option-pricing model with the following inputs
as of June 30, 2023:
Schedule of Fair Value of Warrants Classified as Liabilities
| |
October 2013 Warrants | | |
January 2014 Warrants | |
| |
| | |
| |
Strike price | |
$ | 180.00 | | |
$ | 180.00 | |
Expected dividend yield | |
| 0.00 | % | |
| 0.00 | % |
Contractual term (years) | |
| 0.3 | | |
| 0.5 | |
Cumulative volatility | |
| 136.62 | % | |
| 137.78 | % |
Risk-free rate | |
| 4.88 | % | |
| 4.84 | % |
Value per warrants | |
$ | - | | |
$ | - | |
Fair value (in thousands) | |
$ | - | | |
$ | - | |
The
fair value of the warrants classified as liabilities is estimated using the Black-Scholes option-pricing model with the following inputs
as of December 31, 2022:
| |
October 2013 Warrants | | |
January 2014 Warrants | |
| |
| | |
| |
Strike price | |
$ | 180.00 | | |
$ | 180.00 | |
Expected dividend yield | |
| 0.00 | % | |
| 0.00 | % |
Expected term (years) | |
| 0.8 | | |
| 1.0 | |
Cumulative volatility | |
| 143.06 | % | |
| 145.00 | % |
Risk-free rate | |
| 4.42 | % | |
| 4.40 | % |
Fair value (in thousands) | |
$ | - | | |
$ | - | |
The
Company estimates volatility using its own historical stock price volatility. The expected life assumption is based on the remaining
contractual terms of the warrants. The risk-free rate is based on the zero-coupon rates in effect at the balance sheet date. The dividend
yield used in the pricing model is zero, because the Company has no present intention to pay cash dividends.
8.
Licenses and Collaborations
Merck
Sharp & Dohme Corp.
On
January 2, 2019, the Company entered into an Exclusive License and Research Collaboration Agreement (the “Collaboration Agreement”)
with Merck to discover and develop certain proprietary influenza A/B antiviral agents. Under the terms of the Collaboration Agreement,
Merck funds research and development for the program, including clinical development, and will be responsible for worldwide commercialization
of any products derived from the collaboration. Cocrystal is eligible to receive payments related to designated development, regulatory
and sales milestones with the potential to earn up to $156,000,000, as well as royalties on product sales. Merck can terminate the Collaboration
Agreement at any time prior to the first commercial sale of the first product developed under the Collaboration Agreement, in its sole
discretion, without cause.
Kansas
State University Research Foundation
Cocrystal
entered into a License Agreement with Kansas State University Research Foundation (the “Foundation”) on February 18, 2020
to further develop certain proprietary broad-spectrum antiviral compounds for the treatment of norovirus and coronavirus infections.
Pursuant
to the terms of the License Agreement, the Foundation granted the Company an exclusive royalty bearing license to practice under certain
patent rights, under patent applications covering antivirals against coronaviruses, caliciviruses, and picornaviruses, and related know-how,
including to make and sell therapeutic, diagnostic and prophylactic products.
The
Company agreed to pay the Foundation a one-time non-refundable license initiation fee of $80,000 under the License Agreement, and annual
license maintenance fees. The Company also agreed to make certain future milestone payments, dependent upon the progress of clinical
trials, regulatory approvals, and initiation of commercial sales in the United States and certain countries outside the United States.
9.
Commitments and Contingencies
Commitments
In
the ordinary course of business, the Company enters into non-cancellable leases to purchase equipment and for its facilities, including
related party leases (see Note 10 – Transactions with Related Parties). Leases are accounted for as operating leases or finance
leases, in accordance with ASC 842, Leases.
Operating
Leases
The
Company leases office space in Miami, Florida and research and development laboratory space in Bothell, Washington under operating leases
that expire on August 31, 2024 and January 31, 2024, respectively. For operating leases, the weighted average discount rate is 7.0% and
the weighted average remaining lease term is 0.9 years.
The
following table summarizes the Company’s maturities of operating lease liabilities, by year and in aggregate, as of June 30, 2023
(in thousands):
Schedule
of Maturities of Operating Lease Liabilities
| |
| | |
2023 (excluding the six months ended June 30, 2023) | |
$ | 124 | |
2024 | |
| 58 | |
2025 | |
| - | |
Thereafter | |
| - | |
Total operating lease payments | |
| 182 | |
Less: present value discount | |
| (6 | ) |
Total operating lease liabilities | |
$ | 176 | |
As
of June 30, 2023, the total operating lease liability of $176,000 is classified as $166,000 current operating lease liabilities and $10,000
long term operating lease liabilities.
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, 2023 and 2022, approximately $54,000 and $47,000 of CAM was included in general and
administrative operating expenses on the condensed consolidated statements of operations, respectively.
The
minimum lease payments above include the amounts that would be paid if the Company maintains its Bothell lease for the five-year term,
starting February 2019. The Company had the right to terminate this lease after three years on January 31, 2022, by giving prior notice
at least three months before the early termination date and by paying a termination fee equal to the sum of unamortized leasing commissions
and reimbursement for tenant improvements provided by the landlord amortized at 8.0% over the extended term.
On
September 1, 2021, the Company entered into a three-year lease extension with a limited liability company controlled by Dr. Phillip Frost,
a director and a principal stockholder of the Company. On an annualized basis, straight-line rent expense is approximately $62,000, including
fixed and estimable fees and taxes.
For
the six months ended June 30, 2023 and 2022, operating lease expense, excluding short-term leases, finance leases and CAM charges, totaled
approximately $116,000 and $116,000, respectively, of which $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. The Company is in contact with the lessor to transfer title
of the equipment to the Company.
The
leased lab equipment is depreciable over five years and is presented net of accumulated depreciation on the condensed consolidated balance
sheets under property and equipment. As of June 30, 2023, total right-of-use lab equipment net of depreciation recognized under finance
leases is $162,000 and depreciation expense for the Six months ended June 30, 2023 was $162,000. As of December 31, 2022, total right-of-use
assets lab equipment exchanged for finance lease liabilities was $194,000 and accumulated depreciation for lab equipment under finance
leases was $158,000. The remaining lab equipment under the finance lease terminated on March 31, 2023, and due to the leased equipment’s
remaining 25 months of useful life, it was transferred to fixed assets at book value of $32,000, and continues to depreciate.
Phase
2a Clinical Trial
On
August 3, 2022 the Company engaged hVIVO, a subsidiary of London-based Open Orphan plc (AIM: ORPH), a rapidly growing specialist
contract research organization (“CRO”), to conduct a Phase 2a clinical trial with the Company’s novel,
broad-spectrum, orally administered antiviral influenza candidate. The Company paid a reservation fee of $1.7 million
upon execution of the agreement, which is scheduled to begin in 2023 and has been included in prepaid and other expenses as of June
30, 2023 and December 31, 2022. The total estimated cost of the agreement (including the reservation fee) is approximately $7.2 million.
Contingencies
From
time to time, the Company is a party to, or otherwise involved in, legal proceedings arising in the normal course of business. As of
the date of this report, except as described below, the Company is not aware of any proceedings, threatened or pending, against it which,
if determined adversely, would have a material effect on its business, results of operations, cash flows or financial position.
Liberty
Insurance Underwriters Inc. (“Liberty”) filed suit against us in federal court in Delaware seeking a declaratory judgment
that there was no insurance coverage for any settlement, judgment, or defense costs in the class and derivative litigation, that the
monies totaling approximately $1 million it paid to the Company in connection with the SEC investigation were not covered by insurance,
and for recoupment of the monies already paid. We retained counsel to defend us which has filed an answer to the complaint denying its
material allegations, as well as a counterclaim against Liberty for breach of contract, declaratory judgment, bad faith and violation
of the Washington State Consumer Protection Act, alleging among other things that Liberty wrongfully denied the Company’s claims
for coverage of the class and derivative litigations, and seeking money damages. On June 7, 2022, the court filed a Stipulation and Order
for Entry of Judgment in the amount of $1,359,064 in favor of Liberty (the “Judgment”) following summary judgment granted
by the court to Liberty on all but one of the matters at issue in the case. The Company filed an appeal in July 2022 and paid $1.6 million
into the registry of the court (the “Deposit”) which stayed execution of the Judgment. On
March 29, 2023, the Third Circuit ruled in favor of the Company on the appeal, thereby vacating the trial court’s prior
grant of summary judgment in favor of Liberty. As a result of this ruling, the case has been remanded to the District Court for trial
on the merits of the Company’s coverage claims for defense and settlement costs. On July 18, 2023 the District Court issued an
order establishing deadlines for certain pre-trial matters and setting a trial date of December 4, 2023 for the new trial. The Court
has ordered the return of the $1.6 million Deposit to Cocrystal. In July 2023, the Company filed the appropriate administrative forms
with the court registry for the return of the Deposit and anticipates receipt of the $1.6 million Deposit in the third quarter of 2023.
10.
Transactions with Related Parties
On
September 1, 2021, the Company entered into a three-year lease extension with a limited liability company controlled by Dr. Phillip Frost,
a director and a principal stockholder of the Company. On an annualized basis, straight-line rent expense is approximately $62,000, including
fixed and estimable fees and taxes.
On
April 4, 2023, the Company entered into a Securities Purchase Agreement with two accredited investors (the “Purchasers”)
whereby the Purchasers agreed to purchase a total of 2,030,458 shares of unregistered common stock at a price of $1.97 per share for
a total purchase price of $4,000,000 in two equal $2,000,000 investments. The Purchasers were an entity controlled by a director and
another investor who subsequently joined the Company’s Board of Directors.
11. Subsequent Event
On August 8, 2023, the Company received $1.6
million refunded by the registry of the court in regard to the Liberty matter (See Note 9 - Contingencies).
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Overview
Cocrystal
Pharma, Inc. (the “Company” or “Cocrystal”) is a clinical-stage biotechnology company seeking to discover and
develop novel antiviral therapeutics as treatments for serious and/or chronic viral diseases. We employ unique structure-based technologies
and Nobel Prize winning expertise to create first- and best-in-class antiviral drugs. These technologies are designed to efficiently
deliver small molecule therapeutics that are safe, effective and convenient to administer. We have identified promising preclinical and
clinical-stage antiviral compounds for unmet medical needs including influenza virus, coronavirus, norovirus and hepatitis C virus (“HCV”).
Impact
of Inflation
The
Company does not believe that inflation has had a material effect on its operations to date, other than the impact of inflation on the
general economy. However, there is a risk that the Company’s operating costs could become subject to inflationary pressures in
the future, which could have a material effect on increasing the Company’s operating costs, and which would put additional stress
on the Company’s working capital resources.
Research
and Development Update
During
the six months ended June 30, 2023 the Company continued to focus its research and development efforts primarily in three areas.
Influenza
infections
We
have several candidates under development for the treatment of influenza infection. CC-42344, a novel oral PB2 inhibitor, was selected
as a preclinical lead for the treatment of pandemic and seasonal influenza A, and was advanced to a Phase 1 clinical trial in 2022 as
described in more detail below. This candidate binds to a highly conserved PB2 site of influenza polymerase complex (PB1: PB2: PA) and
exhibits a novel mechanism of action. CC-42344 showed excellent antiviral activity against influenza A strains, including avian pandemic
strains and Tamiflu and Xofluza resistant strains, and has favorable pharmacokinetic and drug resistance profiles.
In
March 2022 enrollment was initiated in a randomized, double-blind, placebo-controlled Phase 1 study of CC-42344, which was conducted
in Australia. In April 2022 we announced preliminary results from the first two cohorts of the single-ascending dose portion of the study
in which CC-42344 demonstrated a favorable safety and pharmacokinetic profile. In December 2022, we reported favorable safety and tolerability
results from a Phase 1 study of CC-42344 for the treatment of both pandemic and seasonal influenza A. Preparations are underway to initiate
a Phase 2a human challenge clinical trial with CC-42344 as an oral treatment for influenza A.
In
addition, novel inhibitors effective against both influenza strains A and B have been identified and are in the preclinical stage. Several
of these have potencies approaching single-digit nanomolar. On January 2, 2019, the Company entered into an Exclusive License and Research
Collaboration Agreement (the “Collaboration Agreement”) with Merck Sharp & Dohme Corp. (“Merck”) to discover
and develop certain proprietary influenza A/B antiviral agents. See “Note 8. Licenses and Collaborations-Merck Sharp & Dohme
Corp.” in the footnotes accompanying the financial statements contained in this report for more information.
In
January 2021, we announced that we completed all research obligations under the Merck exclusive worldwide license and collaboration agreement,
and that Merck would be solely responsible for further development of the influenza A/B antiviral compounds that were discovered using
Cocrystal’s unique structure-based technologies and Nobel Prize-winning expertise. In early 2023, Merck reported that it is continuing
development of the influenza A/B antiviral compounds under the terms of our Collaboration Agreement and is legally protecting the intellectual
property for both companies of the compounds covered under the collaboration.
Coronavirus
infections
In
October 2022, we announced the selection of a novel, broad-spectrum antiviral drug candidate CDI-988 for clinical development as an oral
treatment for SARS-CoV-2, the virus that causes COVID-19. CDI-988 targets a highly conserved region in the active site of SARS-CoV-2
main (3CL) protease required for viral replication and was specifically designed and developed as an oral antiviral candidate for COVID-19
using Cocrystal’s proprietary structure-based drug discovery platform technology.
In
January 2022, we announced the selection of two investigational novel antiviral drug candidates, CDI-988 and CDI-873, for further development
as oral treatments for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. Both compounds exhibited superior in vitro
potency against SARS-CoV-2 with activity maintained against variants of concern. In preclinical studies, both candidates demonstrated
a favorable safety profile and pharmacokinetic properties supportive of daily oral dosing. We are preparing for a randomized, double-blind,
placebo-controlled Phase 1 study of CDI-988 later this year.
Norovirus
Infections
We
have developed CDI-988 as a dual broad-spectrum antiviral inhibitor that targets a highly conserved region in the active site of coronavirus,
norovirus, and other 3CL viral proteases. In August 2023, we announced the selection of CDI-988 as our lead norovirus infection oral
candidate. Our planned randomized, double-blind, placebo-controlled Phase 1 study of CDI-988 for coronavirus is also expected to serve
our requirements of a norovirus Phase 1 study.
Results
of Operations for the Six Months Ended June 30, 2023 compared to the Six Months Ended June 30, 2022
Research
and Development Expense
Research
and development expense consists primarily of compensation-related costs for our employees dedicated to research and development activities
and for our Scientific Advisory Board members, 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, 2023, and 2022 were $2,801,000
and $2,361,000, respectively. The increase of $440,000 was primarily due to our
Influenza CC-42344 product candidate moving from a Phase 1 to Phase 2a clinical trial. In addition, the preparation of CDI
-988 Covid 19 and norovirus programs moving into clinical trial resulted in higher research and development expenses in the
2023 period.
Total
research and development expenses for the six months ended June 30, 2023 and 2022 were $6,708,000 and $5,233,000,
respectively. The increase of $1,475,000 was primarily due to preparations for the CC-42344 Phase 2a clinical trial for pandemic and
seasonal influenza A, and our oral CDI-988 Covid-19 and norovirus clinical lead moving toward clinical
trials and reduced by tax credits of $491,000 for research and development expenses.
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, 2023, and 2022 were $1,538,000 and $1,375,000, respectively. The increase
of $163,000 was primarily due professional fees and general
corporate cost increases.
General
and administrative expenses for the six months ended June 30, 2023 and 2022 were $2,742,000 and $2,708,000,
respectively. The increase of $34,000 was primarily due to professional fees and general corporate cost increases.
There
was no impairment for six months ended June 30, 2023. On June 30, 2022, the carrying value of the reporting unit exceeded the market
capitalization of the Company resulting in goodwill impaired in its entirety and the Company recorded a $19,092,000 non-cash
impairment.
During the three and six months ended June 30, 2022 the Company paid $1.6
million into the registry of the court that was expensed as legal settlement. See “Note 9. Commitments and Contingencies”
in the footnotes accompanying the financial statements contained in this report for more information on this litigation.
Interest
Income (Expense), Net
Interest income (expense) for the
three months ended June 30, 2023 and 2022 was $140,000 and $0, respectively, and for the six months ended June 30, 2023 and 2022 was $140,000
and ($1,000), respectively. The interest income was primarily from interest earned on cash
in bank.
Other
Income (Expense)
In
accordance with U.S. GAAP, we record other income or expense based upon the computed change in fair value of our outstanding warrants
that are accounted for as liabilities. The fair value of our outstanding warrants is inversely related to the fair value of the underlying
common stock; as such, an increase in the price of our common stock during a given period generally results in other expense. Conversely,
a decrease in the price of our common stock generally results in other income. The change in the fair value of derivative liabilities
for the six months ended June 30, 2023 and 2022 was $0 and $12,000,
respectively.
In
2022, the Company established a wholly owned subsidiary in Australia, making it subject to foreign exchange rate fluctuations. Foreign
exchange loss during the six months ended June 30, 2023 and 2022 was $45,000 and $14,000, respectively.
Income
Taxes
No
income tax benefit or expense was recognized for the three and six months ended June 30, 2023 and
2022. The Company’s effective income tax rate was 0.00% for the three and
six months ended June 30, 2023 and 2022. As a result of the Company’s cumulative losses, management has concluded that a
full valuation allowance against the Company’s net deferred tax assets is appropriate.
Net
Loss
As
a result of the above factors, net loss for the three and six months ended June 30, 2023 was $4,166,000 and $9,355,000, respectively,
compared with a net loss for the three and six months ended June 30, 2022 was $24,428,000 and $28,636,000, respectively, as a result
of developments related to our expenses described above. In addition, in the three and six months ended June 30, 2022 the Company recorded
a $19,092,000 impairment of goodwill related to a significant decrease in our stock price during those periods, resulting in an overall
reduction in market capitalization and our recorded net book value exceeding our market capitalization as of June 30, 2022, with no similar
charge in the corresponding 2023 periods.
Liquidity
and Capital Resources
Net
cash used in operating activities was $8,659,000 for the six months ended June 30, 2023 compared
with net cash used in operating activities of $7,634,000 for the same period in 2022. This
increase was primarily due to completion of our Influenza A Phase 1 clinical trial and preparation for our anticipated Influenza A Phase
2a clinical trial and COVID-19 Phase 1 clinical trial in 2023.
We
used $59,000 net cash for investing activities during the six months ended June 30, 2023 compared
with no net cash used for the same period in 2022. For the six months ended June 30, 2023 the level of investments increased compared
with June 30, 2022 due to capital expenditure to replace laboratory equipment require to due age.
Net
cash provided by financing activities totaled $3,993,000 for the six months ended June 30, 2023
compared with net cash used in financing activities of $13,000 for the same period
in 2022. On April 4, 2023, the Company raised $4,000,000 in a private placement sale of 2,030,458
shares of our common stock.
The
Company has not yet established an ongoing source of revenue sufficient to cover its operating costs. The Company had $32,419,000 unrestricted
cash on June 30, 2023. The Company believes it has sufficient cash to maintain planned operations for more than the next 12 months.
We
have focused our efforts on research and development activities, including through collaborations with suitable partners. We have been
profitable on a quarterly basis but have never been profitable on an annual basis. We have no products approved for sale and have incurred
operating losses and negative operating cash flows on an annual basis since inception.
The
Company’s interim consolidated financial statements are prepared using generally accepted accounting principles in the United States
of America applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal
course of business. Historically, public and private equity offerings have been our principal source of liquidity.
The
Company is party to the At-The-Market Offering Agreement, dated July 1, 2020 (“ATM Agreement”) with H.C. Wainwright &
Co., LLC (“Wainwright”), pursuant to which the Company may issue and sell over time and from time to time, to or through
Wainwright, up to $10,000,000 of shares of the Company’s common stock. During
January 2021, the Company sold 1,030,000 shares of its common stock pursuant to the ATM Agreement for net proceeds of approximately $2,072,000.
There were no sales under the ATM Agreement during the six months ended June 30, 2023.
On
April 4, 2023, the Company entered into a Securities Purchase Agreement with two accredited investors (the “Purchasers”)
pursuant to which the Purchasers purchased a total of 2,030,458 shares of common stock at a price of $1.97 per share for a total purchase
price of $4,000,000 in two equal $2,000,000 investments in an unregistered offering
exempt from registration pursuant to Section 4(a)(2) of the Securities Act of 1933 and Rule 506(b) promulgated thereunder.
As
the Company continues to incur losses, achieving profitability is dependent upon the successful development, approval and commercialization
of its product candidates, and achieving a level of revenues adequate to support the Company’s cost structure. The Company may
never achieve profitability, and unless and until it does, the Company will continue to need to raise additional capital. Management
intends to fund future operations through additional private or public equity offerings and through arrangements with strategic partners
or from other sources. There can be no assurances, however, that additional funding will be available on terms acceptable to the Company,
or at all, and any equity financing may be very dilutive to existing stockholders.
Cautionary
Note Regarding Forward-Looking Statements
This
report includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements
regarding the future effectiveness of our product candidates, our plans for the future development of preclinical and clinical drug candidates,
the expected time of achieving certain value driving milestones in our programs, including reporting the results of the Phase 1 study
and commencing the Phase 2a clinical study for our Influenza A program, and progressing our COVID-19 and norovirus programs towards clinical
development, our expectations regarding future operating results and liquidity. The words “believe,” “may,” “estimate,”
“continue,” “anticipate,” “intend,” “should,” “plan,” “could,”
“target,” “potential,” “is likely,” “will,” “expect” and similar expressions,
as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on
our current expectations and projections about future events and financial trends that we believe may affect our financial condition,
results of operations, business strategy and financial needs.
The
results anticipated by any or all of these forward-looking statements might not occur. Important factors that could cause actual results
to differ from those in the forward-looking statements include the risks and uncertainties arising from the risks arising from inflation,
interest rate increases, the recent banking crisis, the possibility of a recession and the Ukraine war on our Company, our collaboration
partners, and on the U.S., U.K., Australia and global economies, including manufacturing and research delays arising from raw materials
and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain
raw materials and test animals as well as similar problems with our vendors and our current and any future CROs and contract manufacturing
organizations (CMOs), the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, our reliance on Merck
for further development in the influenza A/B program under the license and collaboration agreement, our and our collaboration partners’
technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and
future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes,
development of effective treatments and/or vaccines by competitors, including as part of the programs financed by governmental authorities,
potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop, and
the outcome of the ongoing litigation with Liberty. Further information on our risk factors is contained in our filings with the SEC,
including our Annual Report on Form 10-K for the year ended December 31, 2022. We undertake no obligation to publicly update or revise
any forward-looking statements, whether as the result of new information, future events or otherwise.
Critical
Accounting Policies and Estimates
In
our Annual Report on Form 10-K for the year ended December 31, 2022, we disclosed our critical accounting policies and estimates upon
which our financial statements are derived.
Accounting
estimates. The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires
management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent
assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting
period. Actual results could differ significantly from these estimates.
Readers
are encouraged to review these disclosures in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 in
conjunction with the review of this report.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not
applicable.
ITEM
4. CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
We
carried out an evaluation, under the supervision and with the participation of our management, including our Co-Chief Executive Officers
and Chief Financial Officer, of the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e)
of the Securities Exchange Act of 1934 (the “Exchange Act”) as of the end of the period covered by this report. Based on
that evaluation, our Co-Chief Executive Officers and Chief Financial Officer have concluded that our disclosure controls and procedures
as of June 30, 2023 were effective to ensure that information required to be disclosed by us in reports that we file or submit under
the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s
rules and forms.
Changes
in Internal Control over Financial Reporting
There
were no material changes in our internal controls over financial reporting or in other factors that could materially affect, or are reasonably
likely to affect, our internal controls over financial reporting during the quarter ended June 30, 2023. Because of its inherent limitations,
internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness
to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of
compliance with the policies or procedures may deteriorate.
PART
II — OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS
From
time to time, the Company is a party to, or otherwise involved in, legal proceedings arising in the normal course of business. During
the reporting period, except as set forth below, there have been no material changes to the description of legal proceedings set forth
in our Annual Report on Form 10-K for the year ended December 31, 2022 and our Quarterly Report on Form 10-Q for the quarter ended March
31, 2023.
Liberty
Insurance Underwriters Inc. (“Liberty”) filed suit against us in federal court in Delaware seeking a declaratory judgment
that there was no insurance coverage for any settlement, judgment, or defense costs in the class and derivative litigation, that the
monies totaling approximately $1 million it paid to the Company in connection with the SEC investigation were not covered by insurance,
and for recoupment of the monies already paid. We retained counsel to defend us which has filed an answer to the complaint denying its
material allegations, as well as a counterclaim against Liberty for breach of contract, declaratory judgment, bad faith and violation
of the Washington State Consumer Protection Act, alleging among other things that Liberty wrongfully denied the Company’s claims
for coverage of the class and derivative litigations, and seeking money damages. On June 7, 2022, the court filed a Stipulation and Order
for Entry of Judgment in the amount of $1,359,064 in favor of Liberty (the “Judgment”) following summary judgment granted
by the court to Liberty on all but one of the matters at issue in the case. The Company filed an appeal in July 2022 and paid $1.6 million
into the registry of the court (the “Deposit”) which stayed execution of the Judgment. On
March 29, 2023, the Third Circuit ruled in favor of the Company on the appeal, thereby vacating the trial court’s prior
grant of summary judgment in favor of Liberty. As a result of this ruling, the case was remanded to the District Court for trial on the
merits of the Company’s coverage claims for defense and settlement costs. On July 18, 2023 the District Court issued an order establishing
deadlines for certain pre-trial matters and setting a trial date of December 4, 2023 for the new trial. The Court has ordered the return
of the $1.6 million Deposit to Cocrystal. In July 2023, the Company filed the appropriate administrative forms with the court registry
for the return of the Deposit and anticipates receipt of the $1.6 million Deposit in the third quarter of 2023. See “Note 9. Commitments
and Contingencies” in the footnotes accompanying the financial statements contained in this report for more information
on this litigation.
ITEM
1.A RISK FACTORS
None.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
All
recent sales of unregistered securities have been previously reported.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
4. MINE SAFETY DISCLOSURES
Not
applicable.
ITEM
5. OTHER INFORMATION
None.
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.
**
Certain schedules and other attachments have been omitted. The Company undertakes to furnish the omitted schedules and attachments to
the Securities and Exchange Commission upon request.
Copies
of this report (including the financial statements) and any of the exhibits referred to above will be furnished at no cost to our stockholders
who make a written request to our Corporate Secretary at Cocrystal Pharma, Inc., 4400 Biscayne Blvd, Suite 101, Miami, FL 33137.
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, 2023 |
By:
|
/s/
Sam Lee |
|
|
Sam
Lee |
|
|
President
and Co-Chief Executive Officer |
|
|
(Principal
Executive Officer) |
Dated:
August 14, 2023 |
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, 2023
/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, 2023
/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, 2023
/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,
2023, 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, 2023
In
connection with the quarterly report of Cocrystal Pharma, Inc. (the “Company”) on Form 10-Q for the quarter ended June 30,
2023, 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, 2023
v3.23.2
Cover - shares
|
6 Months Ended |
|
Jun. 30, 2023 |
Aug. 14, 2023 |
Cover [Abstract] |
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|
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|
Document Period End Date |
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|
|
Document Fiscal Period Focus |
Q2
|
|
Document Fiscal Year Focus |
2023
|
|
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
|
|
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COCP
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NASDAQ
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v3.23.2
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Current assets: |
|
|
Cash |
$ 32,419
|
$ 37,144
|
Restricted cash |
75
|
75
|
Tax credit receivable |
1,207
|
716
|
Prepaid expenses and other current assets |
2,060
|
2,243
|
Total current assets |
35,761
|
40,178
|
Property and equipment, net |
305
|
342
|
Deposits |
46
|
46
|
Operating lease right-of-use assets, net (including $72 and $99 respectively, to related party) |
167
|
274
|
Total assets |
36,279
|
40,840
|
Current liabilities: |
|
|
Accounts payable and accrued expenses |
1,421
|
976
|
Current maturities of finance lease liabilities |
|
7
|
Current maturities of operating lease liabilities (including $62 and $59 respectively, to related party) |
166
|
233
|
Total current liabilities |
1,587
|
1,216
|
Long-term liabilities: |
|
|
Operating lease liabilities (including $10 and $42 respectively, to related party) |
10
|
57
|
Total liabilities |
1,597
|
1,273
|
Commitments and contingencies |
|
|
Stockholders’ equity: |
|
|
Common stock, $0.001 par value; 150,000 shares authorized as of June 30, 2023, and December 31, 2022; 10,174 and 8,143 shares issued and outstanding as of June 30, 2023 and December 31, 2022 |
10
|
8
|
Additional paid-in capital |
341,957
|
337,489
|
Accumulated deficit |
(307,285)
|
(297,930)
|
Total stockholders’ equity |
34,682
|
39,567
|
Total liabilities and stockholders’ equity |
$ 36,279
|
$ 40,840
|
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v3.23.2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Operating lease right of use assets related party |
$ 72
|
$ 99
|
Operating lease liabilities related party current |
62
|
59
|
Operating lease liabilities related party non-current |
$ 10
|
$ 42
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
150,000,000
|
150,000,000
|
Common stock, shares issued |
10,174,000
|
8,143,000
|
Common stock, shares outstanding |
10,174,000
|
8,143,000
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.2
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Operating expenses: |
|
|
|
|
Research and development |
$ 2,801
|
$ 2,361
|
$ 6,708
|
$ 5,233
|
General and administrative |
1,538
|
1,375
|
2,742
|
2,708
|
Legal settlement |
|
1,600
|
|
1,600
|
Impairments |
|
19,092
|
|
19,092
|
Total operating expenses |
4,339
|
24,428
|
9,450
|
28,633
|
Loss from operations |
(4,339)
|
(24,428)
|
(9,450)
|
(28,633)
|
Other income (expense): |
|
|
|
|
Interest income (expense), net |
140
|
|
140
|
(1)
|
Foreign exchange loss |
33
|
(1)
|
(45)
|
(14)
|
Change in fair value of derivative liabilities |
|
1
|
|
12
|
Total other expense, net |
173
|
|
95
|
(3)
|
Net loss |
$ (4,166)
|
$ (24,428)
|
$ (9,355)
|
$ (28,636)
|
Net loss per common share, basic |
$ (0.41)
|
$ (3.00)
|
$ (1.03)
|
$ (3.48)
|
Net loss per common share, diluted |
$ (0.41)
|
$ (3.00)
|
$ (1.03)
|
$ (3.48)
|
Weighted average number of common shares outstanding, basic |
10,065
|
8,143
|
9,109
|
8,143
|
Weighted average number of common shares outstanding, diluted |
10,065
|
8,143
|
9,109
|
8,143
|
X |
- DefinitionAmount of write-down of assets recognized in the income statement. Includes, but is not limited to, losses from tangible assets, intangible assets and goodwill.
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v3.23.2
Condensed Consolidated Statements Of Stockholders Equity (Unaudited) - USD ($) shares in Thousands, $ in Thousands |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Beginning balance, value at Dec. 31, 2021 |
$ 8
|
$ 336,544
|
$ (259,093)
|
$ 77,549
|
Beginning balance, shares at Dec. 31, 2021 |
8,143
|
|
|
|
Stock-based compensation |
|
239
|
|
239
|
Net loss |
|
|
(4,208)
|
(4,208)
|
Ending balance, value at Mar. 31, 2022 |
$ 8
|
336,783
|
(263,301)
|
73,580
|
Ending balance, shares at Mar. 31, 2022 |
8,143
|
|
|
|
Beginning balance, value at Dec. 31, 2021 |
$ 8
|
336,544
|
(259,093)
|
77,549
|
Beginning balance, shares at Dec. 31, 2021 |
8,143
|
|
|
|
Net loss |
|
|
|
(28,636)
|
Ending balance, value at Jun. 30, 2022 |
$ 8
|
337,024
|
(287,729)
|
49,393
|
Ending balance, shares at Jun. 30, 2022 |
8,143
|
|
|
|
Beginning balance, value at Mar. 31, 2022 |
$ 8
|
336,783
|
(263,301)
|
73,580
|
Beginning balance, shares at Mar. 31, 2022 |
8,143
|
|
|
|
Stock-based compensation |
|
241
|
|
241
|
Net loss |
|
|
(24,428)
|
(24,428)
|
Ending balance, value at Jun. 30, 2022 |
$ 8
|
337,024
|
(287,729)
|
49,393
|
Ending balance, shares at Jun. 30, 2022 |
8,143
|
|
|
|
Beginning balance, value at Dec. 31, 2022 |
$ 8
|
337,489
|
(297,930)
|
39,567
|
Beginning balance, shares at Dec. 31, 2022 |
8,143
|
|
|
|
Stock-based compensation |
|
291
|
|
291
|
Net loss |
|
|
(5,189)
|
(5,189)
|
Ending balance, value at Mar. 31, 2023 |
$ 8
|
337,780
|
(303,119)
|
34,669
|
Ending balance, shares at Mar. 31, 2023 |
8,143
|
|
|
|
Beginning balance, value at Dec. 31, 2022 |
$ 8
|
337,489
|
(297,930)
|
39,567
|
Beginning balance, shares at Dec. 31, 2022 |
8,143
|
|
|
|
Net loss |
|
|
|
(9,355)
|
Ending balance, value at Jun. 30, 2023 |
$ 10
|
341,957
|
(307,285)
|
34,682
|
Ending balance, shares at Jun. 30, 2023 |
10,174
|
|
|
|
Beginning balance, value at Mar. 31, 2023 |
$ 8
|
337,780
|
(303,119)
|
34,669
|
Beginning balance, shares at Mar. 31, 2023 |
8,143
|
|
|
|
Stock-based compensation |
|
179
|
|
179
|
Net loss |
|
|
(4,166)
|
(4,166)
|
Sale of common stock, net of transaction costs |
$ 2
|
3,998
|
|
4,000
|
Sale of common stock, net of transaction costs, shares |
2,031
|
|
|
|
Ending balance, value at Jun. 30, 2023 |
$ 10
|
$ 341,957
|
$ (307,285)
|
$ 34,682
|
Ending balance, shares at Jun. 30, 2023 |
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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v3.23.2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Operating activities: |
|
|
Net loss |
$ (9,355,000)
|
$ (28,636,000)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation and amortization expense |
96,000
|
90,000
|
Amortization of right of use assets |
108,000
|
100,000
|
Loss on impairment of goodwill |
|
19,092,000
|
Stock-based compensation |
470,000
|
480,000
|
Payments on operating lease liabilities |
(115,000)
|
(102,000)
|
Change in fair value of derivative liabilities |
|
(12,000)
|
Changes in operating assets and liabilities: |
|
|
Prepaid expenses and other current assets |
183,000
|
80,000
|
Tax credit receivable |
(491,000)
|
|
Accounts payable and accrued expenses |
445,000
|
(326,000)
|
Settlement payable |
|
1,600,000
|
Net cash used in operating activities |
(8,659,000)
|
(7,634,000)
|
Investing activities: |
|
|
Purchases of property and equipment |
(59,000)
|
|
Net cash used in investing activities |
(59,000)
|
|
Financing activities: |
|
|
Payments on finance lease liabilities |
(7,000)
|
(13,000)
|
Proceeds from sale of common stock, net of transaction costs |
4,000,000
|
|
Net cash provided by (used in) financing activities |
3,993,000
|
(13,000)
|
Net decrease in cash and restricted cash |
(4,725,000)
|
(7,647,000)
|
Cash and restricted cash at beginning of period |
37,219,000
|
58,755,000
|
Cash and restricted cash at end of period |
$ 32,494,000
|
$ 51,108,000
|
X |
- DefinitionIncrease decrease in settlement payable.
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v3.23.2
Organization and Business
|
6 Months Ended |
Jun. 30, 2023 |
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
since its initial funding in 2008. 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, 2023, the Company has primarily funded its operations through equity offerings.
In
September 2021, the Company opened a wholly owned foreign subsidiary in Australia named Cocrystal Pharma Australia, Ltd (“Cocrystal
Australia”) with the objective of operating clinical trials in Australia.
On
September 27, 2022, the Company filed a Certificate of Amendment to the Certificate of Incorporation (the “Amendment”) with
the Delaware Secretary of State to effect a reverse stock split of all outstanding shares of the Company’s common stock at a ratio
of one-for-12. At the Company’s 2022 Annual Meeting of Stockholders, holders of a majority of the outstanding voting power approved
an amendment to the Certificate of Incorporation of the Company to effect a reverse stock split of all outstanding shares of our common
stock at a ratio to be determined by the Board of Directors within a range of one-for-four through one-for-12. Following such approval,
the Board of Directors determined to effect the reverse stock split at the ratio of one-for-12. The Amendment became effective October
11, 2022 and the effect of the reverse stock split was reflected on the Nasdaq Stock Market.
All
share and per share amounts have been retroactively restated to reflect the one-for-12 stock split
as if it occurred at the beginning of the earliest period presented.
|
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v3.23.2
Basis of Presentation and Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2023 |
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, 2022 filed
on March 29, 2023 (“Annual Report”).
Principles
of Consolidation
The
consolidated financial statements include the accounts of Cocrystal Pharma, Inc. and its wholly owned subsidiaries: Cocrystal Discovery,
Inc., Cocrystal Pharma Australia Pty Ltd., RFS Pharma, LLC and Cocrystal Merger Sub, Inc. Intercompany transactions and balances have
been eliminated.
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 derivative liabilities, recoverability
of deferred tax assets, 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, 2023 and December 31, 2022, our primary operating accounts held approximately $32,419,000 and $37,144,000,
respectively, and our collateral account balance was $75,000 and $75,000 at a different institution. The Company has not experienced
any losses in such accounts and believes it is not exposed to significant risks thereof.
Foreign
Currency Transactions
The
Company and its subsidiaries use the U.S. dollar as functional currency. Foreign currency transactions are initially measured and recorded
in the functional currency using the exchange rate on the date of the transaction. Foreign exchange gains and losses arising from settlement
of foreign currency transactions are recognized in profit and loss.
Cocrystal
Australia maintains its records in Australian dollars. The monetary assets and liabilities of Cocrystal Australia are remeasured into
the functional currency using the closing rate at the end of every reporting period. All nonmonetary assets and liabilities and related
profit and loss accounts are remeasured into the functional currency using the historical exchange rates. Profit and loss accounts, other
than those that are remeasured using the historical exchange rates, are remeasured into the functional currency using the average exchange
rate for the period. Foreign exchange gains and losses arising from the remeasurement into the functional currency is recognized in profit
and loss.
Fair
Value Measurements
FASB
Accounting Standards Codification (“ASC”) 820 defines fair value, establishes a framework for measuring fair value under
U.S. GAAP and enhances disclosures about fair value measurements. Fair value is defined under ASC 820 as the exchange price that would
be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or
liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value
under ASC 820 must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes a fair value
hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used
to measure fair value which are the following:
|
Level
1 — quoted prices in active markets for identical assets or liabilities. |
|
|
|
Level
2 — other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement
date. |
|
|
|
Level
3 — significant unobservable inputs that reflect management’s best estimate of what market participants would use to
price the assets or liabilities at the measurement date. |
The
Company categorizes its cash and restricted cash as Level 1 fair value measurements. The Company categorizes its warrants potentially
settleable in cash as Level 2 fair value measurements. The warrants potentially settleable in cash are measured at fair value on a recurring
basis and are being marked to fair value at each reporting date until they are completely settled or meet the requirements to be accounted
for as component of stockholders’ equity. The warrants are valued using the Black-Scholes option pricing model as discussed in
Note 7 – Warrants.
At
June 30, 2023 and December 31, 2022, the carrying amounts of financial assets and liabilities, such as cash, accounts receivable, other
assets, and accounts payable and accrued expenses approximate their fair values due to their short-term nature. The carrying values of
leases payable approximate their fair values due to the fact that the interest rates on these obligations are based on prevailing market
interest rates.
The
Company’s derivative liabilities are considered Level 3 measurements.
Long-Lived
Assets
The
Company regularly reviews the carrying value and estimated lives of its long-lived assets, including property and equipment, to determine
whether indicators of impairment may exist which warrant adjustments to carrying values or estimated useful lives. The determinants used
for this evaluation include management’s estimate of the asset’s ability to generate positive income from operations and
positive cash flow in future periods as well as the strategic significance of the assets to the Company’s business objective. Should
an impairment exist, the impairment loss would be measured based on the excess of the carrying amount over the asset’s fair value.
Research
and Development Expenses
Research
and development costs consist primarily of fees paid to consultants and outside service providers, and other expenses relating to the
acquisition, design, development and testing of the Company’s clinical products. All
research and development costs are expensed as incurred. Research and development costs are presented net of tax credits.
The
Company’s Australian subsidiary is entitled to receive government assistance in the form of refundable and non-refundable research
and development tax credits from the federal and provincial taxation authorities, based on qualifying expenditures incurred during the
fiscal year. The refundable credits are from the provincial taxation authorities and are not dependent on its ongoing tax status or tax
position and accordingly are not considered part of income taxes. The Company records refundable tax credits as a reduction of research
and development expenses when the Company can reasonably estimate the amounts and it is more likely than not, they will be received.
During the year ended December 31, 2022, the Company recorded tax
credits of $805,000 as a reduction of research and development expense, of which approximately
$716,000 was recorded as tax credit receivable as of the year then ended. The Company recorded an accrued tax credit receivable of $491,000
for the six months ended June 30, 2023, resulting in a tax credit receivable of $1,207,000 at June 30, 2023.
Income
Taxes
The
Company accounts for income taxes under the asset and liability method. Under this method, deferred tax assets and liabilities are determined
based on differences between financial reporting and tax bases of assets and liabilities and are measured using enacted tax rates and
laws that are expected to be in effect when the differences are expected to be recovered or settled. Realization of deferred tax assets
is dependent upon future taxable income. A valuation allowance is recognized if it is more likely than not that some portion or all of
a deferred tax asset will not be realized based on the weight of available evidence, including expected future earnings. The Company
recognizes an uncertain tax position in its financial statements when it concludes that a tax position is more likely than not to be
sustained upon examination based solely on its technical merits. Only after a tax position passes the first step of recognition will
measurement be required. Under the measurement step, the tax benefit is measured as the largest amount of benefit that is more likely
than not to be realized upon effective settlement. This is determined on a cumulative probability basis. The full impact of any change
in recognition or measurement is reflected in the period in which such change occurs. The Company elects to accrue any interest or penalties
related to income taxes as part of its income tax expense.
As
of June 30, 2023, the Company assessed its income tax expense based on its projected future taxable income for the year ending December
31, 2023 and therefore recorded no amount for income tax expense for the six months ended June 30, 2023. In addition, the Company has
significant deferred tax assets available to offset income tax expense due to net operating loss carry forwards which are currently subject
to a full valuation allowance based on the Company’s assessment of future taxable income. Refer to our Annual Report on Form 10-K
for the year ended December 31, 2022 for more information.
Stock-Based
Compensation
The
Company recognizes compensation expense using a fair value-based method for costs related to stock-based payments, including stock options.
The fair value of options awarded to employees is measured on the date of grant using the Black-Scholes option pricing model and is recognized
as expense over the requisite service period on a straight-line basis.
Use
of the Black-Scholes option pricing model requires the input of subjective assumptions including expected volatility, expected term,
and a risk-free interest rate. The Company estimates volatility using a blend of its own historical stock price volatility as well as
that of market comparable entities since the Company’s common stock has limited trading history and limited observable volatility
of its own. The expected term of the options is estimated by using the SEC Staff Bulletin No. 107’s Simplified Method for Estimate
Expected Term. The risk-free interest rate is estimated using comparable published federal funds rates.
Common
Stock Purchase Warrants and Other Derivative Financial Instruments
We
classify as equity any contracts that require physical settlement or net-share settlement or provide us a choice of net-cash settlement
or settlement in our own shares (physical settlement or net-share settlement) provided that such contracts are indexed to our own stock
as defined in ASC 815-40, Contracts in Entity’s Own Equity. We classify as assets or liabilities any contracts that require
net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside our control)
or give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement). We assess
classification of our common stock purchase warrants and other freestanding derivatives at each reporting date to determine whether a
change in classification between assets and liabilities is required.
Net
Income (Loss) per Share
The
Company accounts for and discloses net income (loss) per common share in accordance with FASB ASC Topic 260, Earnings Per Share.
Basic income (loss) per common share is computed by dividing income (loss) attributable to common stockholders by the weighted average
number of common shares outstanding. Diluted net income (loss) per common share is computed by dividing net income (loss) attributable
to common stockholders by the weighted average number of common shares that would have been outstanding during the period assuming the
issuance of common stock for all potential dilutive common shares outstanding. Potential common shares consist of shares issuable upon
the exercise of stock options and warrants and the conversion of convertible notes payable.
The
following table sets forth the number of potential common shares excluded from the calculations of net loss per diluted share because
their inclusion would be anti-dilutive (in thousands):
Schedule
of Antidilutive Securities Excluded from Calculations of Net Loss Per Share
| |
2023 | | |
2022 | |
| |
June 30, | |
| |
2023 | | |
2022 | |
Outstanding options to purchase common stock | |
| 350 | | |
| 2,340 | |
Warrants to purchase common stock | |
| 13 | | |
| 243 | |
Total | |
| 363 | | |
| 2,583 | |
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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v3.23.2
Property and Equipment
|
6 Months Ended |
Jun. 30, 2023 |
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, 2023, and December 31, 2022, property and equipment consists of (in thousands):
Schedule
of Property and Equipment
| |
June 30, 2023 | | |
December 31, 2022 | |
Lab equipment | |
$ | 1,708 | | |
$ | 1,631 | |
Finance lease right-of-use lab equipment | |
| 162 | | |
| 194 | |
Computer and office equipment | |
| 145 | | |
| 131 | |
Total property and equipment | |
| 2,015 | | |
| 1,956 | |
Less: accumulated depreciation and amortization | |
| (1,710 | ) | |
| (1,614 | ) |
Property and equipment, net | |
$ | 305 | | |
$ | 342 | |
Total
depreciation and amortization expense were approximately $96,000 and $90,000 for the six months
ended June 30, 2023 and 2022, which includes amortization expense of $7,164 and $7,716 for the six months ended June 30, 2023 and 2022,
respectively, related to assets under finance lease. For additional finance leases information, refer to Note 9 – Commitments and
Contingencies.
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- DefinitionThe entire disclosure for long-lived, physical asset used in normal conduct of business and not intended for resale. Includes, but is not limited to, work of art, historical treasure, and similar asset classified as collections.
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v3.23.2
Accounts Payable and Accrued Expenses
|
6 Months Ended |
Jun. 30, 2023 |
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, 2023 | | |
December 31, 2022 | |
Accounts payable | |
$ | 1,041 | | |
$ | 614 | |
Accrued compensation | |
| 150 | | |
| 130 | |
Accrued other expenses | |
| 230 | | |
| 232 | |
Total accounts payable and accrued expenses | |
$ | 1,421 | | |
$ | 976 | |
Accounts
payable and accrued other expenses contain unpaid general and administrative expenses and costs related to research and development that
have been billed and estimated unbilled, respectively, as of period-end.
|