Item 8. Financial Statements and Supplementary Data
Item
8. Financial Statements
The
consolidated financial statements of Cocrystal Pharma, Inc. required by this Item are described in Item 15 of this Annual Report on Form
10-K and are presented beginning on page F-1.
47
COCRYSTAL
PHARMA, INC.
INDEX
TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Report
of Independent Registered Certified Public Accounting Firm (PCAOB ID No. 572 )
F-1
Consolidated Balance Sheets
F-2
Consolidated Statements of Operations
F-3
Consolidated Statements of Stockholders’ Equity
F-4
Consolidated Statements of Cash Flows
F-5
Notes to Consolidated Financial Statements
F-6
48
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board
of Directors and Stockholders
Cocrystal
Pharma, Inc.
Bothell,
Washington
Opinion
on the Consolidated Financial Statements
We
have audited the accompanying consolidated balance sheets of Cocrystal Pharma, Inc. (the “Company”) and subsidiaries as of
December 31, 2021 and 2020, the related consolidated statements of operations, stockholders’ equity, and cash flows for the years
then ended, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion,
the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31,
2021 and 2020, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles
generally accepted in the United States of America.
Basis
for Opinion
These
consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion
on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public
Company Accounting Oversight Board of the United States (“PCAOB”) and are required to be independent with respect to the
Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission
and the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part
of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing
an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether
due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
We believe that our audits provide a reasonable basis for our opinion.
Critical
Audit Matter
The
critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated
or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial
statements and (2) involved especially challenging, subjective, or complex judgments. The communication of critical audit matters does
not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical
audit matter below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
Goodwill
Impairment Assessment
As
described in Notes 2 and 4 to the consolidated financial statements, the Company’s consolidated net goodwill balance was $19,092,000
as of December 31, 2021. Management conducts impairment testing at the reporting unit level on an annual basis as of November 30th or
more frequently if events or circumstances indicate a potential impairment. Reporting unit is tested for impairment by comparing the
estimated fair value of the reporting unit to its carrying amount. Impairment is measured as the excess of a reporting unit’s carrying
amount over its fair value, not to exceed the carrying amount of goodwill for that reporting unit. Management estimates the fair value
of the reporting unit using the income approach, specifically the discounted cash flow method, and uses a market capitalization corroboration.
This requires the use of significant estimates and assumptions, including future revenues, projected margins and capital spending, terminal
growth rates, and discount rates.
The
principal considerations for our determination that performing procedures relating to the goodwill impairment assessment is a critical
audit matter are the significant judgment by management when developing the fair value measurement of the reporting unit, which in turn
led to a high degree of auditor judgment, subjectivity, and effort in performing audit procedures and evaluating audit evidence related
to management’s significant assumptions related to future revenues, projected margins and capital spending, terminal growth rates,
and discount rates. In addition, the audit effort involved the use of professionals with specialized skill and knowledge.
Addressing
the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated
financial statements. These procedures included, among others, (i) testing management’s process for developing the fair value of
the reporting units, (ii) evaluating the appropriateness of the discounted cash flow models, (iii) testing the completeness and accuracy
of underlying data used in the models, (iv) performing an independent market corroboration calculation, and (iv) evaluating the significant
assumptions used by management related to future revenues, projected margins and capital spending, terminal growth rates, and discount
rates. Evaluating management’s assumptions related to future revenues and projected margins and capital spending involved evaluating
whether the assumptions used by management were reasonable considering the current and past performance of the reporting unit, third-party
industry data, and whether these assumptions were consistent with evidence obtained in other areas of the audit. Professionals with specialized
skill and knowledge were used to assist in the evaluation of the Company’s discounted cash flow models and the terminal growth
rates and discount rates assumptions.
We
have served as the Company’s auditor since 2019.
/s/
Weinberg & Company
Los
Angeles, California
March
23, 2022
F- 1
COCRYSTAL
PHARMA, INC.
CONSOLIDATED
BALANCE SHEETS
(in
thousands)
December 31,
2021
December 31,
2020
Assets
Current assets:
Cash
$ 58,705
$ 33,010
Restricted cash
50
50
Accounts receivable
-
556
Prepaid expenses and other current assets
568
399
Total current assets
59,323
34,015
Property and equipment, net
453
591
Deposits
46
46
Operating lease right-of-use assets, net (including $ 153 to related party)
478
498
Goodwill
19,092
19,092
Total assets
$ 79,392
$ 54,242
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses
$ 1,297
$ 1,080
Current maturities of finance lease liabilities
27
39
Current maturities of operating lease liabilities (including $ 53 to related party)
209
178
Derivative liabilities
12
61
Total current liabilities
1,545
1,358
Long-term liabilities:
Finance lease liabilities
7
34
Operating lease liabilities (including $ 101 to related party)
291
345
Total long-term liabilities
298
379
Total liabilities
1,843
1,737
Commitments and contingencies
-
Stockholders’ equity:
Common stock, $ 0.001 par value; 150,000 and 100,000 shares authorized as of December 31, 2021 and December 31, 2020, respectively; 97,469 and 70,439 shares issued and outstanding as of December 31, 2021 and December 31, 2020, respectively
98
71
Additional paid-in capital
336,544
297,342
Accumulated deficit
( 259,093 )
( 244,908 )
Total stockholders’ equity
77,549
52,505
Total liabilities and stockholders’ equity
$ 79,392
$ 54,242
See
accompanying notes to consolidated financial statements.
F- 2
COCRYSTAL
PHARMA, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(in
thousands, except per share data)
2021
2020
December 31,
2021
2020
Revenues:
Collaboration revenue
$ -
$ 2,014
Operating expenses:
Research and development
8,794
6,034
General and administrative
5,427
5,566
Total operating expenses
14,221
11,600
Loss from operations
( 14,221 )
( 9,586 )
Other (expense) income:
Interest expense, net
( 4 )
( 8 )
Change in fair value of derivative liabilities
49
( 54 )
Foreign exchange loss
( 9 )
-
Total other income (expense), net
36
( 62 )
Net loss
$ ( 14,185 )
$ ( 9,648 )
Net loss per common share:
Loss per share, basic and diluted
$ ( 0.16 )
$ ( 0.17 )
Weighted average number of common shares outstanding, basic and diluted
88,368
55,217
See
accompanying notes to consolidated financial statements.
F- 3
COCRYSTAL
PHARMA, INC.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY
(in
thousands)
Common Stock
Additional
Paid-in
Accumulated
Total
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance as of December 31, 2019
35,150
$ 36
$ 260,932
$ ( 235,260 )
$ 25,708
Stock-based compensation
-
-
662
-
662
Sale of common stock, net of transaction costs
35,289
35
35,748
-
35,783
Net loss
-
-
-
( 9,648 )
( 9,648 )
Balance as of December 31, 2020
70,439
71
297,342
( 244,908 )
52,505
Stock-based compensation
-
-
724
-
724
Sale of common stock, net of transaction costs
27,030
27
38,478
-
38,505
Net loss
-
-
-
( 14,185 )
( 14,185 )
Balance as of December 31, 2021
97,469
$ 98
$ 336,544
$ ( 259,093 )
$ 77,549
See
accompanying notes to consolidated financial statements.
F- 4
COCRYSTAL
PHARMA, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(in
thousands)
2021
2020
Operating activities:
Net loss
$ ( 14,185 )
$ ( 9,648 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense
190
157
Amortization of right of use assets
192
179
Stock-based compensation
724
662
Payments on operating lease liabilities
( 195 )
( 177 )
Change in fair value of derivative liabilities
( 49 )
54
Changes in operating assets and liabilities:
Accounts receivable
556
88
Prepaid expenses and other current assets
( 169 )
( 230 )
Deposits
-
4
Accounts payable and accrued expenses
217
( 919 )
Net cash used in operating activities
( 12,719 )
( 9,830 )
Investing activities:
Purchases of property and equipment
( 52 )
( 240 )
Net cash used in investing activities
( 52 )
( 240 )
Financing activities:
Payments of finance lease obligations
( 39 )
( 121 )
Proceeds from sale of common stock, net of transaction costs
38,505
35,783
Net cash provided by financing activities
38,466
35,662
Net increase in cash and restricted cash
25,695
25,592
Cash and restricted cash at beginning of period
33,060
7,468
Cash and restricted cash at end of period
$ 58,755
$ 33,060
SUPPLEMENTAL DISCLOSURE OF NON-CASH FINANCING ACTIVITIES:
Recognition of finance lease right-of-use asset and liability
$ -
$ 77
Recognition of operating lease right-of-use assets and operating lease liabilities
$ 171
$ -
See
accompanying notes to consolidated financial statements.
F- 5
COCRYSTAL
PHARMA, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
1.
Organization and Business
Cocrystal
Pharma, Inc. (“we”, the “Company” or “Cocrystal”), a biopharmaceutical company, has been developing
novel technologies and approaches to create first-in-class and 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 was formerly incorporated in Nevada under the name Biozone Pharmaceuticals, Inc. (“Biozone”). On January 2, 2014,
Biozone Pharmaceuticals, Inc. sold substantially all of its assets to MusclePharm Corporation (“MusclePharm”), and, on the
same day, merged with Cocrystal Discovery, Inc. in a transaction accounted for as a reverse merger. Following the merger, the Company
assumed Cocrystal Discovery, Inc.’s business plan and operations. On March 18, 2014, the Company reincorporated in Delaware under
the name Cocrystal Pharma, Inc.
Effective
November 25, 2014, Cocrystal Pharma, Inc. and affiliated entities completed a series of merger transactions as a result of which Cocrystal
Pharma, Inc. merged with RFS Pharma, LLC, a Georgia limited liability company (“RFS Pharma”). We refer to the surviving entity
of this merger as “Cocrystal” or the “Company.”
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.
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 December 31, 2021, the Company has primarily funded its operations through equity offerings.
The
Company has no pharmaceutical products approved for sale, has not generated any revenues to date from pharmaceutical product sales, and
has incurred significant operating losses since inception. The Company has never been profitable and has incurred losses from operations
of $ 14,185,000 and $ 9,648,000 in the years ended December 31, 2021 and 2020, respectively.
As
the disease caused by SARS-CoV-2, a novel strain of coronavirus, COVID-19 continues to impact the economy of the
U.S. and other countries around the world, we are committed to the need of antiviral therapeutics for this unprecedented challenge. The
extent to which this coronavirus impacts our business and operating results will depend on future developments that are highly uncertain
and cannot be accurately predicted, including new information that may emerge concerning the virus, including variants of the virus,
and the actions to contain the spread of or to detect, prevent, or treat COVID-19, among others.
In
March 2020, in response to the COVID-19 pandemic, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law.
The CARES Act provides numerous tax provisions and other stimulus measures, including temporary changes regarding the prior and future
utilization of net operating losses, temporary changes to the prior and future limitations on interest deductions, temporary suspension
of certain payment requirements for the employer portion of Social Security taxes, technical corrections from prior tax legislation for
tax depreciation of certain qualified improvement property, and the creation of certain payroll tax credits associated with the retention
of employees.
Liquidity
The
Company’s consolidated financial statements are prepared using generally accepted accounting principles in the United States of
America applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal
course of business. The Company has incurred net losses and negative operating cash flows since inception. For the year ended December
31, 2021, the Company recorded a net loss of approximately $ 14,185,000 and used approximately $ 12,719,000 of cash in operating activities.
On
December 31, 2021, the Company had cash and cash equivalents of approximately $ 58,755,000 . We believe that our current resources will
be sufficient to fund our operations for the foreseeable future. This estimate is based, in part, upon our currently projected expenditures
for 2022, 2023 and 2024.
The
Company will need to continue obtaining adequate capital to fund operating losses until it becomes profitable. The Company can give no
assurances that the additional capital it is able to raise, if any, will be sufficient to meet its needs, or that any such financing
will be obtainable on acceptable terms. If the Company is unable to obtain adequate capital, it could be forced to cease operations or
substantially curtail its drug development activities. The Company expects to continue incurring substantial operating losses and negative
cash flows from operations over the next several years during its pre-clinical and clinical development phases.
F- 6
2.
Basis of Presentation and Significant Accounting Policies
Basis
of Presentation
The
accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S.
GAAP”), and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for reporting of
annual financial information.
Principles
of Consolidation
The
consolidated financial statements include the accounts of Cocrystal Pharma, Inc. and its wholly owned subsidiaries: Cocrystal Pharma
Australia Pty, Ltd., Cocrystal Discovery, Inc., Cocrystal Merger Sub, Inc., Baker Cummins Corp. and Biozone Laboratories, 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, estimated useful lives of fixed assets, and forecast assumptions used in the impairment testing of goodwill.
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 accounts are held. At December
31, 2021 and 2020, our primary operating account held approximately $ 58,705,000
and $ 33,010,000 ,
respectively, and our collateral account balance of $ 50,000
and other cash accounts are maintained at different
institutions. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risks thereof.
Risks
and Uncertainties
The
Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s
future operating results and cause actual results to vary materially from expectations include, but are not limited to, rapid technological
change, ability to obtain regulatory approvals, competition from currently available treatments and therapies, competition from larger
companies, effective protection of proprietary technology, maintenance of strategic relationships, and dependence on key individuals.
Products
developed by the Company will require clearances from the U.S. Food and Drug Administration (the “FDA”) and other international
regulatory agencies prior to commercial sales in their respective markets. The Company’s products may not receive the necessary
clearances and if they are denied clearance, clearance is delayed, or the Company is unable to maintain clearance, the Company’s
business could be materially, adversely impacted.
F- 7
Cash
and Restricted Cash
The
Company considers all highly liquid investments with an original maturity from the date of purchase of three months or less to be cash
equivalents, and the Company held no cash equivalents as of December 31, 2021 and 2020.
The
following table provides a reconciliation of cash and restricted cash reported within the consolidated balance sheets that sum to the
total of the same such amounts shown in the consolidated statements of cash flows (in thousands):
Schedule of Reconciliation of Cash And Restricted Cash
December 31,
2021
December 31,
2020
Cash
$ 58,705
$ 33,010
Restricted cash
50
50
Total cash and restricted cash shown in the statements of cash flows
$ 58,755
$ 33,060
Restricted
cash represents amounts pledged as collateral for financing arrangements that are currently limited to the issuance of business credit
cards. The restriction will end upon the conclusion of these financing arrangements.
Property
and Equipment
Property
and equipment, which consists of lab equipment (including lab equipment under capital lease), computer equipment, and office equipment,
is recorded at cost and depreciated over the estimated useful lives of the underlying assets (three to five years) using the straight-line
method.
Fair
Value Measurements
FASB
Accounting Standards Codification (“ASC”) 820 defines fair value, establishes a framework for measuring fair value under
generally accepted accounting principles 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 3 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 10 – Warrants.
At
December 31, 2021 and 2020, 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 notes
payable approximate their fair values due to the fact that the interest rates on these obligations are based on prevailing market interest
rates.
F- 8
The
Company has not transferred any financial instruments into or out of Level 3 classification during the years ended December 31, 2021
and 2020. A reconciliation of the beginning and ending Level 3 liabilities for is as follows (in thousands):
Schedule of Reconciliation of Beginning and Ending Level 3 Liabilities
2021
2020
Fair Value Measurements Using
Significant Unobservable Inputs
(Level 3)
2021
2020
Balance, January 1,
$ 61
$ 7
Beginning balance
$ 61
$ 7
Change in fair value of warrants potentially settleable in cash (Note 10)
( 49 )
54
Balance at December 31,
$ 12
$ 61
Ending balance
$ 12
$ 61
Goodwill
In
November 2014, goodwill was recorded in connection with the acquisition of RFS Pharma.
We
evaluate indefinite-lived intangible assets and goodwill for impairment annually, as of November 30, or more frequently when events or
circumstances indicate that impairment may have occurred. As part of the impairment evaluation, we may elect to perform an assessment
of qualitative factors. If this qualitative assessment indicates that it is more likely than not that the fair value of the indefinite-lived
intangible asset or the reporting unit (for goodwill) is less than its carrying value, we then would proceed with the quantitative impairment
test to compare the fair value to the carrying value and record an impairment charge if the carrying value exceeds the fair value.
Fair
value is typically estimated using an income approach based on the present value of future discounted cash flows. The significant estimates
in the discounted cash flow model primarily include the discount rate, and rates of future revenue and expense growth and/or profitability
of the acquired assets. In performing the impairment test, the Company considered, among other factors, the Company’s intention
for future use of acquired assets, analyses of historical financial performance and estimates of future performance of Cocrystal’s
product candidates.
At
December 31, 2021, the Company had goodwill of approximately $ 19,092,000 . The Company completed its annual impairment test in November
2021, and at that time determined the fair value of its reporting unit, under both the Company’s Nasdaq market capitalization and
an income approach analysis; both methods did exceed the carrying value as of December 31, 2021; therefore, management did not consider
goodwill to be impaired.
F- 9
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.
Patent
and Licensing Related Legal and Filing Costs
Due
to the significant uncertainty associated with the successful development of one or more commercially viable products based on the Company’s
research efforts and related patent applications, all patent-related legal and filing fees and licensing-related legal fees are charged
to operations as incurred. Patent and licensing-related legal and filing costs were $ 533,000 and $ 273,000 for the years ended December
31, 2021 and 2020, respectively. Patent and licensing related legal and filing costs are included in general and administrative costs
in the Company’s consolidated statements of operations.
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.
Reclassifications
The
Company has reclassified $ 273,000 of costs previously included in research and development costs in the prior year to general and administrative
costs to conform to current year presentation.
Revenue
Recognition
The
Company recognizes revenue from research and development arrangements. In accordance with Accounting Standards Codification (“ASC”)
Topic 606– Revenue from Contracts with Customers (“Topic 606”), revenue is recognized when a customer obtains
control of promised goods or services. The amount of revenue recognized reflects the consideration to which the Company expects to be
entitled to receive in exchange for these goods and services.
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.
Under the terms of the Collaboration Agreement, Merck will fund research and development for the program, including clinical development,
and will be responsible for worldwide commercialization of any products derived from the collaboration. During the year ended December
31, 2021 the Company did not recognize revenue for research and development activities related to its influenza A/B program or for program
expense reimbursements. During the year ended December 31, 2020 the Company recognized revenue of $ 2,014,000 as consideration in exchange
for conveyance of intellectual property rights at the signing of the agreement, $ 1,779,000 for research and development activities related
to its influenza A/B program and $ 235,000 for program expense reimbursements.
Income
Taxes
The
Company accounts for income taxes under the asset and liability method. Under this method, deferred tax assets and liabilities are determined
based on differences between financial reporting and tax bases of assets and liabilities and are measured using enacted tax rates and
laws that are expected to be in effect when the differences are expected to be recovered or settled. Realization of deferred tax assets
is dependent upon future taxable income. A valuation allowance is recognized if it is more likely than not that some portion or all of
a deferred tax asset will not be realized based on the weight of available evidence, including expected future earnings. The Company
recognizes an uncertain tax position in its financial statements when it concludes that a tax position is more likely than not to be
sustained upon examination based solely on its technical merits. Only after a tax position passes the first step of recognition will
measurement be required. Under the measurement step, the tax benefit is measured as the largest amount of benefit that is more likely
than not to be realized upon effective settlement. This is determined on a cumulative probability basis. The full impact of any change
in recognition or measurement is reflected in the period in which such change occurs. The Company elects to accrue any interest or penalties
related to income taxes as part of its income tax expense.
F- 10
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 Securities and Exchange Commission 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.
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
2021
2020
December 31,
2021
2020
Outstanding options to purchase common stock
2,473
1,780
Warrants to purchase common stock
243
243
Total
2,716
2,023
Recent
Accounting Pronouncements
The
following are new FASB Accounting Standards Updates that have not been adopted by the Company as of December 31, 2021, and contain detail
regarding the effective dates:
In
June 2016, the FASB issued ASU No. 2016-13, Credit Losses - Measurement of Credit Losses on Financial Instruments (“ASC 326”).
The standard significantly changes how entities will measure credit losses for most financial assets, including accounts and notes receivables.
The standard will replace today’s “incurred loss” approach with an “expected loss” model, under which companies
will recognize allowances based on expected rather than incurred losses. Entities will apply the standard’s provisions as a cumulative-effect
adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is effective. The standard is
effective for interim and annual reporting periods beginning after December 15, 2019. The adoption of ASU 2016-13 is not expected to
have a material impact on the Company’s financial position, results of operations, and cash flows.
In
August 2020, the FASB issued ASU 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts
in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity
(“ASU 2020-06”). ASU 2020-06 simplifies the accounting for convertible debt by eliminating the beneficial conversion and
cash conversion accounting models. Upon adoption of ASU 2020-06, convertible debt proceeds, unless issued with a substantial premium
or an embedded conversion feature that is not clearly and closely related to the host contract, will no longer be allocated between debt
and equity components. This modification will reduce the issue discount and result in less non-cash interest expense in financial statements.
ASU 2020-06 also updates the earnings per share calculation and requires entities to assume share settlement when the convertible debt
can be settled in cash or shares. For contracts in an entity’s own equity, the type of contracts primarily affected by ASU 2020-06
are freestanding and embedded features that are accounted for as derivatives under the current guidance due to a failure to meet the
settlement assessment by removing the requirements to (i) consider whether the contract would be settled in registered shares, (ii) consider
whether collateral is required to be posted, and (iii) assess shareholder rights. ASU 2020-06 is effective for fiscal years beginning
after December 15, 2023. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, and only if
adopted as of the beginning of such fiscal year. The Company adopted ASU 2020-06 effective January 1, 2021. The adoption of ASU 2020-06
did not have any impact on the Company’s consolidated financial statement presentation or disclosures.
F- 11
Other
recent authoritative guidance issued by the FASB (including technical corrections to the ASC), the American Institute of Certified Public
Accountants, and the Securities and Exchange Commission (“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 as of December 31, consists of the following (table in thousands):
Schedule of Property and Equipment
2021
2020
Lab equipment (excluding equipment under finance leases)
$ 1,557
$ 1,498
Finance lease right-of-use lab equipment obtained in exchange for finance lease liabilities, net
194
92
Computer and office equipment
131
120
Total property and equipment
1,882
1,710
Less accumulated depreciation
( 1,429 )
( 1,119 )
Property and equipment, net
$ 453
$ 591
Depreciation
expense was $ 190,000 and $ 157,000 for the years ended December 31, 2021 and 2020, respectively.
4.
Goodwill
At
December 31, 2021 and 2020, the Company had goodwill of $ 19,092,000 . The Company performs an annual impairment test on November 30 th
to determine the fair value of its reporting unit, measured by the Company’s Nasdaq market capitalization and an income approach
analysis. Based on management’s impairment test at November 30, 2021, there was no impairment of goodwill.
5.
Accounts Payable and Accrued Expenses
Accounts
payable and accrued expenses consisted of the following as of December 31, (table in thousands):
Schedule of Accounts Payable and Accrued Expenses
2021
2020
Accounts payable
$ 578
$ 657
Accrued compensation
104
126
Accrued other expenses
615
297
Total accounts payable and accrued expenses
$ 1,297
$ 1,080
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 year-end.
F- 12
6.
Common Stock
As
of December 31, 2021, the Company has authorized 150,000,000 shares of common stock, $ 0.001 par value per share. The Company had approximately
97,469,000 and 70,439,000 shares issued and outstanding as of December 31, 2021 and 2020, respectively.
The
holders of common stock are entitled to one vote for each share of common stock held .
In
January, February, March, August and November 2020, the Company closed a series of placements of its common stock resulting in the sale
of 35,288,697 shares of its common stock for net proceeds after transaction costs of approximately $ 35.8 million.
The
Company was a 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 remainder of 2021.
On
May 4, 2021, the Company entered into an underwriting agreement with H.C. Wainwright & Co., LLC, pursuant to which the Company agreed
to issue and sell 26,000,000 shares of the Company’s common stock at a public offering price of $ 1.54 per share, less underwriting
discounts and commissions (the “Offering”). The Company received approximately $ 36.4 million in net proceeds from the Offering,
after deducting underwriting discounts and estimated offering expenses. The Offering closed on May 7, 2021.
7.
Stock Based Awards
Equity
Incentive Plans
The
Company adopted an equity incentive plan in 2007 (the “2007 Plan”) under which 1,786,635 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 2007 Plan shall be eligible to purchase shares of the Company’s common stock at an exercise price equal to no less than
the fair market value of such stock on the date of grant. The maximum term of options granted under the 2007 Plan is ten years . The options
generally vest 25% after one year, with the remaining balance vesting monthly over the following three years . As of December 31, 2021,
all future options available under the 2007 plan have expired and no options remain available for future grant under this plan.
F- 13
The
Company adopted a second equity incentive plan in 2015 (the “2015 Plan”) under which 1,666,667 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 . The options generally vest 25% after one year, with the remaining balance vesting monthly over the following three years .
As of December 31, 2021, approximately 7.5 million options remain available for future grant under the 2015 Plan.
The
following table summarizes stock option transactions for the 2007 Plan and 2015 Plan, collectively, for the year ended December 31, 2021
and 2020 (table 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, 2019
3,588
931
$ 4.14
$ -
Exercised
-
-
-
-
Granted
( 928 )
928
1.33
29
Expired
( 476 )
-
-
-
Cancelled
79
( 79 )
7.37
-
Balance at December 31, 2020
2,263
1,780
$ 2.53
$ 29
Increase in authorized options
5,000
-
-
-
Granted
( 1,037 )
1,037
1.11
-
Expired
976
-
-
-
Cancelled
341
( 344 )
2.18
-
Balance at December 31, 2021
7,543
2,473
$ 1.98
$ -
During
the year ended December 31, 2021 the Company granted stock options to officers, directors, employees and consultants to purchase a total
of 1,037,000 shares of common stock. The options have an exercise price of $ 1.11 per share, expire in ten years , and vest as follows:
one half vests on the one-year anniversary of the grant date and the remainder will vest in eight equal quarterly increments with the
first such quarterly increment vesting on September 30, 2021 . The total fair value of these options at the grant date was approximately
$ 965,000 using the Black-Scholes Option pricing model. The Black-Scholes option pricing model includes the following weighted average
assumptions for grants made during the year ended December 31, 2021:
Schedule
of Weighted Average Assumptions Used for Grants
Assumptions:
Weighted average per share grant date fair value
$ 0.930
Risk-free interest rate
0.91 %
Expected dividend yield
0.00 %
Expected volatility
114.62 %
Expected terms (in years)
5.83
During
the year ended December 31, 2020 the Company granted stock options to officers, directors, employees and consultants to purchase a total
of 928,000 shares of common stock. The options have an exercise price of $ 1.33 per share, expire in ten years , and vest as follows: one
half vests on the one-year anniversary of the grant date and the remainder will vest in eight equal quarterly increments with the first
such quarterly increment vesting on September 30, 2021 . The total fair value of these options at the grant date was approximately $ 944,000
using the Black-Scholes Option pricing model. The Company did not grant any stock options during the year ended December 31, 2019. The
Black-Scholes option pricing model includes the following weighted average assumptions for grants made during the year ended December
31, 2020:
Assumptions:
Weighted average per share grant date fair value
$ 1.08
Risk-free interest rate
0.44 %
Expected dividend yield
0.00 %
Expected volatility
107.41 %
Expected terms (in years)
5.9
The
Company accounts for share-based awards to employees and nonemployee directors and consultants in accordance with the provisions of ASC
718, Compensation—Stock Compensation. , and under the recently issued guidance following FASB’s pronouncement, ASU
2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting . Under
ASC 718, and applicable updates adopted, share-based awards are valued at fair value on the date of grant and that fair value is recognized
over the requisite service, or vesting, period. The Company values its equity awards using the Black-Scholes option pricing model, and
accounts for forfeitures when they occur. For the years ended December 31, 2021 and 2020, equity-based compensation expense recorded
was $ 724,00 and $ 662,000 , respectively.
As
of December 31, 2021, there was $ 1,292,000 of total unrecognized compensation expense related to non-vested stock options that is expected
to be recognized over a weighted average period of 9.1 years. For options granted and outstanding, there were 2,473,000 options outstanding
which were fully vested or expected to vest, with an aggregate intrinsic value of $ 0.00 , a weighted average exercise price of $ 1.98 ,
and weighted average remaining contractual term of 8.0 years at December 31, 2021. For vested and exercisable options, outstanding shares
totaled 984,000 , with an aggregate intrinsic value of $ 0.00 . These options had a weighted-average exercise price of $ 3.05 per share and
a weighted-average remaining contractual term of 6.4 years at December 31, 2021.
F- 14
The
aggregate intrinsic value of outstanding and exercisable options at December 31, 2021 was calculated based on the closing price of the
Company’s common stock as reported on the Nasdaq Capital Market on December 31, 2021 of approximately $ 0.65 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 as of December 31, (in thousands):
Schedule
of Common Stock Reserved for Future Issuance
2021
2020
Stock options issued and outstanding
2,473
1,780
Shares authorized for future option grants
7,543
2,263
Warrants outstanding
243
243
Total
10,259
4,286
8.
Warrants
The
following is a summary of activity in the number of warrants outstanding to purchase the Company’s common stock for the years ended
December 31, 2021 and 2020 (table 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, 2019
84
26
133
243
Exercised
-
-
-
-
Granted
-
-
-
-
Expired
-
-
-
-
Outstanding, December 31, 2020
84
26
133
243
Exercised
-
-
-
-
Granted
-
-
-
-
Expired
-
-
-
-
Outstanding, December 31, 2021
84
26
133
243
Expiration date
Oct 27, 2022
Oct 24, 2023
Jan 16, 2024
Warrants
consist of equity-classified warrants and warrants with the potential to be settled in cash, which are liability-classified warrants.
As of December 31, 2021, and 2020, 159,000 warrants are accounted for as liabilities and 84,000 warrants are accounted for as equity.
Warrants
Classified as Equity
Equity-classified
warrants consist of stand-alone warrants with rights to buy shares of the Company at a pre-designated price on or before the date of
expiration, irrespective of the market price. These purchase warrants are not attached to any debt or equity instruments, thus considered
freestanding, and there are no circumstances under ASC 815 that require the warrants to be classified as liabilities or as derivatives.
Thus, our May 2018 warrants are classified as equity, and their value are carried in the additional paid-in capital account in the stockholders’
equity section of the balance sheet.
F- 15
These
warrants were granted to the underwriters and investment brokers for services provided related to the Company’s May 2018 equity
financing, and collectively grant the right to buy 84,211 shares of our stock at $ 2.09 per share for up to four years until expiration
from the commencement date of October 27, 2018.
Warrants
Classified as Liabilities
Liability-classified
warrants consist of warrants issued by Biozone in connection with equity financings in October 2013 and January 2014, which were assumed
by the Company in connection with its merger with Biozone 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 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 December 31, 2021:
Schedule
of Fair Value of Warrants Classified as Liabilities
October 2013
Warrants
January 2014
Warrants
Strike price
$ 15.00
$ 15.00
Expected dividend yield
0.00 %
0.00 %
Expected term (years)
1.8
2.0
Cumulative volatility
129.65 %
128.17 %
Risk-free rate
0.06 %
0.08 %
Fair value (in thousands)
$ 2
$ 10
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, 2020:
October 2013
Warrants
January 2014
Warrants
Strike price
$ 15.00
$ 15.00
Expected dividend yield
0.00 %
0.00 %
Expected term (years)
2.8
3.0
Cumulative volatility
119.18 %
116.65 %
Risk-free rate
0.16 %
0.18 %
Fair value (in thousands)
$ 9
$ 52
The
Company estimates volatility using its own historical stock price volatility based upon the range of periods consistent with the expected
life of the warrants. 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.
9.
Licenses and Collaborations
Merck
Sharp & Dohme Corp.
On
January 2, 2019, the Company entered into an Exclusive License and Research Collaboration Agreement (the “Collaboration Agreement”)
with Merck Sharp & Dohme Corp. (“Merck”) to discover and develop certain proprietary influenza A/B antiviral agents.
Under the terms of the Collaboration Agreement, Merck will fund research and development for the program, including clinical development,
and will be responsible for worldwide commercialization of any products derived from the collaboration. Cocrystal received an upfront
payment of $ 4 million and 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. The Company continues working with Merck under this Collaboration Agreement.
F- 16
The
Company recognized revenue for the years ended December 31, 2021 and 2020 of $ 0 and $ 2,014,000 , respectively. As of December 31, 2021
and 2020, accounts receivable of $ 0 and $ 556,000 was due from Merck, respectively.
Kansas
State University Research Foundation
On
February 18, 2020, Cocrystal Pharma, Inc. (the “Company”) entered into a License Agreement (the “Agreement”)
with Kansas State University Research Foundation (the “Foundation”) effective February 12, 2020.
Pursuant
to the terms of the Agreement, the Foundation granted the Company an exclusive for human use a royalty bearing license to practice under
certain patent rights, including a patent and a patent application covering antiviral compounds against coronaviruses and norovirus,
and related know-how, to make and sell therapeutic, diagnostic and prophylactic products.
The
Company agreed to pay the Foundation a one-time non-refundable license initiation fee in the amount of $ 80,000 and an annual license
maintenance fee in the amount of $ 20,000 per year and agreed to reimburse the Foundation for third party expenses associated with the
filing, prosecution, and maintenance of the patent rights in question. The Company also agreed to make certain future milestone payments
up to $ 3.1 million, 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.
On
April 17, 2020, the Company entered into an Agreement with Foundation effective April 1, 2020. Pursuant to the terms of the Agreement,
the Foundation granted the Company an exclusive for human use a royalty bearing license to practice under certain patent rights, including
a patent and a patent application covering antiviral compounds against coronaviruses and norovirus, and related know-how, to make and
sell therapeutic, diagnostic and prophylactic products.
The
Company agreed to pay the Foundation a one-time non-refundable license initiation fee in the amount of $ 110,000 and an annual license
maintenance fee in the amount of $ 20,000 per year for the first seven (7) years and $ 50,000 per year thereafter and agreed to reimburse
the Foundation for third party expenses associated with the filing, prosecution and maintenance of the patent rights in question. The
Company also agreed to make certain future milestone payments up to $ 4,150,000 , 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. As of December 31,
2021 no milestone payments were due under the agreement.
The
Agreement will remain in effect until the expiration of the patent rights covered by the Agreement, unless earlier terminated pursuant
to customary terms.
10.
Income Taxes
In
accordance with the authoritative guidance for income taxes under ASC 740, a deferred tax asset or liability is determined based on the
difference between the financial statement and the tax basis of assets and liabilities as measured by the enacted tax rates, which will
be in effect when these differences reverse. The Company provides a valuation allowance against net deferred tax assets unless, based
upon the available evidence, it is more likely than not that the deferred tax assets will be realized.
The
Company recognizes the impact of a tax position in the consolidated financial statements only if that position is more likely than not
of being sustained upon examination by taxing authorities, based on the technical merits of the position. The Company’s practice
is to recognize interest and/or penalties related to income tax matters as income tax expense.
F- 17
The
Company is subject to taxation and files income tax returns in the United States, Australia and various state jurisdictions. All tax
years from inception to date are subject to examination by the U.S. and state tax authorities due to the carry-forward of unutilized
net operating losses and research and development credits. Currently, no years are under examination.
Significant
components of the Company’s deferred income taxes at December 31, 2021 and 2020 are shown below (table in thousands):
Schedule
of Deferred Tax Assets and Liabilities
2021
2020
Deferred tax assets:
Net operating loss carryforwards (i)(ii)
$ 19,993
$ 17,240
Compensation
846
837
Research and development tax credits (iii)
2,423
2,182
Other
466
311
Total deferred tax assets
23,728
20,570
Deferred tax liabilities:
Property and equipment
( 21 )
( 20 )
Other
( 105 )
( 107 )
Total deferred tax liabilities
( 126 )
( 127 )
Total deferred taxes, net
23,602
20,443
Valuation allowance
( 23,602 )
( 20,443 )
Deferred tax liability, net
$ -
$ -
The
Company has established a valuation allowance against net deferred tax assets due to the uncertainty that such assets will be realized.
The Company periodically evaluates the recoverability of the deferred tax assets. At such time as it is determined that it is more likely
than not that deferred tax assets will be realizable, the valuation allowance will be reduced.
On
March 27, 2020, the United States enacted the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”). The CARES
Act is an emergency economic stimulus package that includes spending and tax breaks to strengthen the United States economy and fund
a nationwide effort to curtail the effect of COVID-19. While the CARES Act provides sweeping tax changes in response to the COVID-19
pandemic, some of the more significant provisions are the extension of the carryback period of certain losses to five years, and increasing
the ability to deduct interest expense from 30 percent to 50 percent of modified taxable income. The CARES Act also provides for a credit
against employee wages, the opportunity to defer payment of a portion of federal payroll taxes to December 2021 and December 2022 and
enhanced small business loans to assist business impacted by the pandemic. The Company’s tax provision and financial position was
not materially impacted by the CARES Act.
On
December 27, 2020, the United States enacted the Consolidated Appropriations Act which extended and modified many of the tax related
provisions of the CARES Act. The Company does not anticipate a material impact of the Consolidated Appropriations Act on its tax provision
or financial position.
At
December 31, 2021, the Company has federal and state net operating losses (“NOL”) carryforwards of approximately $ 93.2 million
and $ 4.4 million, respectively. The federal and Florida NOL generated after 2017 of $ 31.6 million and $ 4.4 million, respectively, will
carryforward indefinitely. Under the CARES Act, the Internal Revenue Code was amended to allow for federal NOL carrybacks for five years
to offset previous income, or can be carried forward indefinitely to offset 100% of the taxable income for the tax year 2020 and 80%
of the taxable income for the tax years 2021 and thereafter . The federal NOL carryforwards begin to expire in 2026
F- 18
At
December 31, 2021, the Company had federal research credit carryforwards of approximately $ 2.4 million that expire in 2028.
At
December 31, 2021, the Company had federal and state capital loss carryforwards of approximately $ 1.07 million that expire in 2023.
The
above NOL carryforward and the research tax credit carryforward are subject to an annual limitation under the Section 382 and 383 of
the Internal Revenue Code of 1986, and similar state provisions if the Company experienced one or more ownership changes, which would
limit the amount of NOL and tax credit carryforwards that can be utilized to offset future taxable income and tax, respectively. In general,
an ownership change, as defined by Section 382 and 383, results from transactions increasing ownership of certain stockholders or public
groups in the stock of the corporation by more than 50 percentage points over a three-year period. The Company has not completed an IRC
Section 382/382 analysis. If a change in ownership were to have occurred, NOL and tax credits carryforwards could be eliminated or restricted.
If eliminated, the related asset would be removed from the deferred tax asset schedule with a corresponding reduction in the valuation
allowance.
A
reconciliation of the federal statutory income tax rate to the Company’s effective income tax rate is as follows:
Schedule
of Reconciliation of Federal Statutory Income Tax Rate
2021
2020
Statutory federal income tax rate
21.0 %
21.0 %
Goodwill impairment
0 %
0 %
Change in valuation allowance
( 22.3 )%
( 22.5 )%
Other tax, credit and adjustments
1.3 %
1.5 %
Effective income tax rate
0.0 %
0.0 %
11.
Lease Commitments
Operating
Leases
The
Company leases office space in Miami, Florida and laboratory space in Bothell, Washington under operating leases that expire on August
31, 2024 and January 31, 2024 , respectively. The lease for our Miami office is with a related party (see below).
Operating
lease right-of-use (“ROU”) assets and liabilities are recognized at commencement date based on the present value of lease
payments over the lease term. ROU assets represent our right to use an underlying asset for the lease term and lease liabilities represent
our obligation to make lease payments arising from the lease. Generally, the implicit rate of interest in arrangements is not readily
determinable and the Company utilizes its incremental borrowing rate in determining the present value of lease payments. The Company’s
incremental borrowing rate is a hypothetical rate based on its understanding of what its credit rating would be. The operating lease
ROU asset includes any lease payments made and excludes lease incentives.
F- 19
The
components of rent expense and supplemental cash flow information related to leases for the period are as follows (tables in thousands):
Schedule
of Components of Rent Expense and Supplemental Cash Flow Information
Year Ended
December 31,
2021
Lease Cost
Operating lease cost (included in operating expenses in the Company’s consolidated statement of operations)
$ 230
Other Information
Cash paid for amounts included in the measurement of lease liabilities
$ 233
Weighted average remaining lease term – operating leases (in years)
2.3
Average discount rate – operating leases
7.2 %
The
supplemental balance sheet information related to leases for the period is as follows (tables in thousands):
Schedule
of Supplemental Balance Sheet Information
At December 31,
2021
At December 31,
2020
Operating leases
Long-term right-of-use assets of which $ 153 relates to related party, net of amortization of $ 527
$ 478
$ 498
Short-term operating lease liabilities, of which $ 53 relates to related party
209
178
Long-term operating lease liabilities, of which $ 101 relates to related party
291
345
Total operating lease liabilities
$ 500
$ 523
Schedule
of Maturities of Lease Liabilities
Year ending December 31,
(in thousands)
2020
$ -
2021
-
2022
239
2023
246
2024 and thereafter
58
Total minimum operating lease payments
$ 543
Less: present value discount
( 43 )
Total operating lease liabilities
500
The
minimum lease payments above do not include common area maintenance (CAM) charges, which are contractual obligations under the Company’s
Bothell, Washington lease, but are not fixed and can fluctuate from year to year. CAM charges for the Bothell, Washington facility are
calculated and billed based on total common expenses for the building incurred by the lessor and apportioned to tenants based on square
footage. In 2021 and 2020, approximately $ 75,000 and $ 74,000 of CAM charges for the Bothell, Washington lease were included in operating
expenses in the consolidated statements of operations, respectively.
On
September 1, 2018, the Company entered into a lease agreement with a limited liability company controlled by Dr. Phillip Frost, a director,
and a principal shareholder of the Company for the lease of its Miami office (see Note 13 – Transactions with Related Parties).
On September 1, 2021, the Company extended this lease agreement into additional three -year with
m onthly lease payments under this lease total $ 186,000 through September 2024. The minimum lease payments above include taxes
and fees, which are expected to be approximately $ 9,000 annually. As of December 31, 2021, the remaining right of use asset relating
to this lease was $ 154,000 and the remaining lease obligation was $ 154,000 .
Rent
expense, excluding capital leases and CAM charges, for 2021 and 2020 totaled $ 230,000 and $ 228,000 , respectively.
F- 20
Finance
Leases
In
November 2018, the Company entered into two lease agreements to acquire equipment with 18 monthly payments of $ 18,000 payable through
May 27, 2020 and 36 monthly payments of $ 1,000 payable through November 21, 2021. The lease agreements have an effective interest rate
of 8.00 %.
Future
minimum finance lease payments, by year and in aggregate, are as follows:
Schedule
of Maturities of Finance Lease
Year ending December 31,
(in thousands)
2021
$ -
2022
29
2023
7
2024 and thereafter
-
Total minimum capital lease payments
$ 36
The
leased lab equipment is included under property and equipment and depreciable over five years . Total assets and accumulated depreciation
recognized, net, under finance leases was $ 194,000 and $ 143,000 as of December 31, 2021, respectively. Total assets and accumulated depreciation
recognized, net, under finance leases was $ 92,000 and $ 119,000 as of December 31, 2020.
12.
Commitments and Contingencies
Contingencies
From
time to time, the Company is a party to, or otherwise involved in, legal proceedings arising in the normal course of business. As of
the date of this report, except as described below, the Company is not aware of any proceedings, threatened or pending, against it which,
if determined adversely, would have a material effect on its business, results of operations, cash flows or financial position.
F- 21
Liberty
Insurance Underwriters Inc. 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 have 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. Liberty Insurance Underwriters, Inc. filed suit against us in federal court in Delaware seeking a declaratory judgement that
there was no insurance coverage for any settlement, judgement, or defense costs in the class and derivative litigation, the monies totaling
approximately $ 1 million it paid to the Company in connection with the SEC request for information in an investigation was not covered
by insurance, and for the recoupment of the monies already paid. The case has been set for trial in July, 2022.
In
November 2017, Lee Pederson, a former Biozone lawyer, filed a lawsuit in the U.S. District Court in Minnesota against co-defendants the
Company, Dr. Phillip Frost, OPKO Health, Inc. and Brian Keller alleging that defendants engaged in wrongful conduct related to Biozone,
including causing Biozone to enter into an allegedly improper licensing agreement and engaged in alleged market manipulation (“Pederson
I”). On September 13, 2018, the United States District Court granted the Company and its co-defendants’ motion to dismiss
Pederson’s amended complaint in Pederson I for lack of personal jurisdiction in Minnesota. On October 11, 2018, Pederson filed
a notice of appeal with the United States Court of Appeals for the Eighth Circuit. The plaintiff’s appeal was denied and the dismissal
of Pederson I affirmed in March 2020. Meanwhile, in July 2019, Lee Pederson had filed another lawsuit in the U.S. District Court in Minnesota
against co-defendants the Company, Dr. Frost, and Daniel Fisher (“Pederson II”). In his complaint in Pederson II, Pederson
alleges tortious interference by the Company and Dr. Frost with an alleged collaboration agreement between Mr. Pederson and Mr. Fisher.
In Pederson II, Mr. Pederson seeks damages in the amount of $ 800,000
or such other amount as may be determined at
trial. Pederson II had previously been stayed by the court, pending disposition of Pederson I. With that first lawsuit having been dismissed
and appeal denied, the stay was lifted in Pederson II, and the Company and all other defendants in that case filed Motions to Dismiss
the (then amended) complaint. On November 19, 2020 the Magistrate Judge recommended dismissal of Pederson II, and further recommended
that Pederson be restricted from filing any other actions in the District of Minnesota against defendants on the same or similar allegations
as those in Pederson II, and on January 4, 2021 the District Court Judge adopted those recommendations and ordered dismissal of Pederson
II. On February 1, 2021 Pederson filed a Notice of Appeal from the order of dismissal of Pederson II in the Eighth Circuit, and on
December 29, 2021 the Eighth Circuit affirmed the decision of the District Court. Thereafter, on or about January 11, 2022 Pederson sought
via petition, re-hearing en banc by the Eighth Circuit, which petition remains pending.
On
May 19, 2020, A.G.P./Alliance Global Partners (“AGP”), which had previously acted as the Company’s underwriter, placement
agent and sales agent in connection with the Company’s registered and exempt equity offerings, filed a lawsuit against the Company
in the United States District Court for the Southern District of New York alleging violation of a lock-up provision under the Placement
Agent Agreement, dated January 28, 2020 (the “Placement Agent Agreement”), by and between the Company and AGP. AGP seeks
(i) damages estimated in the complaint to be in excess of $ 1
million and attorneys’ fees, and (ii) declaratory
relief. In August 2021, the Company settled the lawsuit filed against it by AGP. Following the Company’s negotiated payment,
the lawsuit was dismissed with prejudice.
While
the Company intends to defend itself vigorously from the claims in the aforementioned disputes, it is unable to predict the outcome of
these legal proceedings. Any potential loss as a result of these legal proceedings cannot be reasonably estimated. As a result, the Company
has not recorded a loss contingency for any of the aforementioned claims.
COVID-19
Our
administrative and finance activities are fully functional out of our Miami, Florida location and our research laboratory in Bothell,
Washington remains open for essential operations while meeting COVID-19 quarantine challenges. Our scientists are also able to continue
working remotely and we remain committed to meeting our corporate and development milestones throughout the year. We have experienced
delays in our supply chain and with service partners as a result of the COVID-19 pandemic, including recent raw material and test animal
shortages affecting our research and development efforts. Also because of the unknown impact from the COVID-19 pandemic, it may have
unanticipated material adverse effects on us in a number of ways including:
●
If
our scientists and other personnel (or their family members) are infected with the virus, it may hamper our ability to engage in
ongoing research activities;
●
Similarly,
we rely on third parties who have been and may in the future be adversely impacted;
●
If
these third parties are and/or continue to be adversely affected by COVID-19, they may focus on other activities which they
may devote their limited time to other priorities rather than to our joint research, which has caused and may in the future cause
material delays in our research and development efforts;
●
We
have experienced and may experience in the future shortages of laboratory materials and other resources which impact our research
activities;
●
As
a result of the continuing impact of the virus, we may fail to get access to third party laboratories which would impact our research
activities; and
●
In
addition to the problems described above, we
may sustain problems due to the serious short-term and possible longer term serious economic disruptions as our economy faces unprecedented
uncertainty.
13.
Transactions with Related Parties
In
September 2018, the Company leased administrative offices from a limited liability company owned by one of the Company’s directors
and principal shareholder, Dr. Phillip Frost. The lease term is three
years with an optional three-year extension. On
an annualized basis, rent expense, including taxes and fees, for this location would be approximately $ 62,000 .
The Company paid a lease deposit of $ 4,000
and total rent and other expenses paid in connection
with this lease were $ 60,000
and $ 59,000
for the years ended December 31, 2021
and 2020 respectively.
F- 22
Item
9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosures
Not
applicable.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.