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of Independent Registered Certified Public Accounting Firm (PCAOB ID No.
−Removed: Consolidated Balance Sheets
−Removed: Consolidated Statements of Operations
−Removed: Consolidated Statements of Stockholders’ Equity
−Removed: Consolidated Statements of Cash Flows
−Removed: Notes to Consolidated Financial Statements
+Added: Balance Sheets
+Added: Statements of Operations
+Added: Statements of Stockholders’ Equity
+Added: Statements of Cash Flows
+Added: to Consolidated Financial Statements
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
31 unchanged sentences
We believe that our audits provide a reasonable basis for our opinion.
−Removed: critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated
+Added: critical audit matter communicated below is a matter arising from the current period audit of the financial statements that were communicated
or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial
2 unchanged sentences
not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical
−Removed: audit matter below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
+Added: audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
Impairment Assessment
−Removed: described in Notes 2 and 4 to the consolidated financial statements, the Company’s consolidated net goodwill balance was $19,092,000
+Added: described in Note 5 to the consolidated financial statements, the Company’s consolidated net goodwill balance was $19,092 as of
+Added: December 31, 2021.
+Added: Management tests its goodwill for impairment on November 30 or more frequently if circumstances indicate that the
+Added: carrying value of a reporting unit may exceed its fair value.
+Added: If the carrying amount of the Company, as a sole reporting unit, including
+Added: goodwill, exceeds its fair value, an impairment loss is recognized in an amount equal to that excess up to the amount of the recorded
+Added: During the second quarter of 2022, the Company experienced a sustained decrease in its share price, and as of June 30, 2022,
+Added: the Company’s market capitalization was below the carrying value of the Company’s net assets.
+Added: Pursuant to current accounting
+Added: guidance, management concluded that this was an impairment triggering event, and performed an impairment assessment of its goodwill.
+Added: Based on the results of the impairment assessment, management determined that its goodwill was impaired and recognized an impairment
+Added: charge of $19,092 related to goodwill during the year ended December 31, 2022.
+Added: Following the impairment, the Company had no remaining
+Added: goodwill as of December 31, 2022.
+Added: identified the evaluation of goodwill impairment as a critical audit matter because of the significant judgment by management when determining
+Added: the fair value of the reporting unit.
+Added: This required a high degree of auditor judgment and increased auditor effort in auditing such assumptions.
+Added: primary procedures we performed to address this critical audit matter included:
+Added: (i) obtained an understanding of management’s process
+Added: for determining the fair value of the reporting unit, (ii) We evaluated the allocation of the Company’s estimated fair value to
+Added: its reporting units and the comparison of the Company’s estimated fair value to its market capitalization, and (iii) we recalculated
+Added: the impairment recorded for goodwill of $19,092 based on the excess of the carrying values of goodwill over its estimated fair value
as of December 31, 2022.
−Removed: Management conducts impairment testing at the reporting unit level on an annual basis as of November 30th or
−Removed: more frequently if events or circumstances indicate a potential impairment.
−Removed: Reporting unit is tested for impairment by comparing the
−Removed: estimated fair value of the reporting unit to its carrying amount.
−Removed: Impairment is measured as the excess of a reporting unit’s carrying
−Removed: amount over its fair value, not to exceed the carrying amount of goodwill for that reporting unit.
−Removed: Management estimates the fair value
−Removed: of the reporting unit using the income approach, specifically the discounted cash flow method, and uses a market capitalization corroboration.
−Removed: This requires the use of significant estimates and assumptions, including future revenues, projected margins and capital spending, terminal
−Removed: growth rates, and discount rates.
−Removed: principal considerations for our determination that performing procedures relating to the goodwill impairment assessment is a critical
−Removed: audit matter are the significant judgment by management when developing the fair value measurement of the reporting unit, which in turn
−Removed: led to a high degree of auditor judgment, subjectivity, and effort in performing audit procedures and evaluating audit evidence related
−Removed: to management’s significant assumptions related to future revenues, projected margins and capital spending, terminal growth rates,
−Removed: and discount rates.
−Removed: In addition, the audit effort involved the use of professionals with specialized skill and knowledge.
−Removed: the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated
−Removed: financial statements.
−Removed: These procedures included, among others, (i) testing management’s process for developing the fair value of
−Removed: the reporting units, (ii) evaluating the appropriateness of the discounted cash flow models, (iii) testing the completeness and accuracy
−Removed: of underlying data used in the models, (iv) performing an independent market corroboration calculation, and (iv) evaluating the significant
−Removed: assumptions used by management related to future revenues, projected margins and capital spending, terminal growth rates, and discount
−Removed: Evaluating management’s assumptions related to future revenues and projected margins and capital spending involved evaluating
−Removed: whether the assumptions used by management were reasonable considering the current and past performance of the reporting unit, third-party
−Removed: industry data, and whether these assumptions were consistent with evidence obtained in other areas of the audit.
−Removed: Professionals with specialized
−Removed: skill and knowledge were used to assist in the evaluation of the Company’s discounted cash flow models and the terminal growth
−Removed: rates and discount rates assumptions.
have served as the Company’s auditor since 2019.
−Removed: Weinberg & Company
−Removed: Angeles, California
+Added: Los Angeles, California
+Added: March 29, 2023
BALANCE SHEETS
+Added: thousands, except per share data)
+Added: credit receivable
+Added: expenses and other current assets
current assets
−Removed: Restricted cash
−Removed: Accounts receivable
−Removed: Prepaid expenses and other current assets
−Removed: Total current assets
−Removed: Property and equipment, net
−Removed: Operating lease right-of-use assets, net (including $ 153 to related party)
−Removed: Liabilities and stockholders’ equity
+Added: and equipment, net
+Added: lease right-of-use assets, net (including $ 99 and $ 153 to related party)
+Added: and stockholders’ equity
+Added: payable and accrued expenses
+Added: maturities of finance lease liabilities
+Added: maturities of operating lease liabilities (including $ 59 and $ 53 to related party)
current liabilities
−Removed: Accounts payable and accrued expenses
−Removed: Current maturities of finance lease liabilities
−Removed: Current maturities of operating lease liabilities (including $ 53 to related party)
−Removed: Derivative liabilities
−Removed: Total current liabilities
+Added: lease liabilities
+Added: lease liabilities (including $ 42 and $ 101 to related party)
long-term liabilities
−Removed: Finance lease liabilities
−Removed: Operating lease liabilities (including $ 101 to related party)
−Removed: Total long-term liabilities
−Removed: Total liabilities
−Removed: Commitments and contingencies
+Added: and contingencies
+Added: Stockholders’
+Added: stock $ 0.001 par value;
+Added: 150,000 shares authorized as of December 31, 2022 and December 31, 2021, respectively;
+Added: 8,143 shares issued
+Added: and outstanding as of December 31, 2022 and December 31, 2021, respectively
+Added: paid-in capital
stockholders’ equity
−Removed: Common stock, $ 0.001 par value;
−Removed: 150,000 and 100,000 shares authorized as of December 31, 2021 and December 31, 2020, respectively;
−Removed: 97,469 and 70,439 shares issued and outstanding as of December 31, 2021 and December 31, 2020, respectively
−Removed: Additional paid-in capital
−Removed: Accumulated deficit
−Removed: Total stockholders’ equity
−Removed: Total liabilities and stockholders’ equity
+Added: liabilities and stockholders’ equity
accompanying notes to consolidated financial statements.
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thousands, except per share data)
−Removed: Collaboration revenue
+Added: and development
+Added: and administrative
operating expenses
−Removed: Research and development
−Removed: General and administrative
−Removed: Total operating expenses
−Removed: Loss from operations
−Removed: Other (expense) income:
−Removed: Interest expense, net
−Removed: Change in fair value of derivative liabilities
−Removed: Foreign exchange loss
−Removed: Total other income (expense), net
−Removed: Net loss per common share:
−Removed: Loss per share, basic and diluted
−Removed: Weighted average number of common shares outstanding, basic and diluted
+Added: from operations
+Added: (expense) income:
+Added: in fair value of derivative liabilities
+Added: exchange loss
+Added: other income (expense), net
+Added: loss per common share:
+Added: per share, basic and diluted
+Added: average number of common shares outstanding, basic and diluted
accompanying notes to consolidated financial statements.
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Balance as of December 31, 2020
−Removed: $ ( 235,260 )
Stock-based compensation
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Balance as of December 31, 2021
+Added: $ ( 259,093 )
Stock-based compensation
−Removed: Sale of common stock, net of transaction costs
Balance as of December 31, 2022
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Operating activities:
−Removed: Adjustments to reconcile net loss to net cash used in operating activities:
−Removed: Depreciation and amortization expense
−Removed: Amortization of right of use assets
+Added: Adjustments to reconcile net loss to net cash
+Added: used in operating activities:
+Added: Depreciation and amortization
+Added: Right of use assets
+Added: Loss on impairment of goodwill
Stock-based compensation
−Removed: Payments on operating lease liabilities
−Removed: Change in fair value of derivative liabilities
−Removed: Changes in operating assets and liabilities:
+Added: Change in operating lease
+Added: Change in fair value of
+Added: derivative liabilities
+Added: Changes in operating assets
+Added: and liabilities:
Accounts receivable
−Removed: Prepaid expenses and other current assets
−Removed: Accounts payable and accrued expenses
−Removed: Net cash used in operating activities
+Added: Tax credit receivable
+Added: Prepaid expenses and other
+Added: current assets
+Added: payable and accrued expenses
+Added: Net cash used in operating
Investing activities:
−Removed: Purchases of property and equipment
−Removed: Net cash used in investing activities
+Added: Purchases of property
+Added: and equipment
+Added: Net cash used in investing
Financing activities:
Payments of finance lease obligations
−Removed: Proceeds from sale of common stock, net of transaction costs
−Removed: Net cash provided by financing activities
−Removed: Net increase in cash and restricted cash
−Removed: Cash and restricted cash at beginning of period
−Removed: Cash and restricted cash at end of period
−Removed: SUPPLEMENTAL DISCLOSURE OF NON-CASH FINANCING ACTIVITIES:
−Removed: Recognition of finance lease right-of-use asset and liability
−Removed: Recognition of operating lease right-of-use assets and operating lease liabilities
+Added: Proceeds from sale of
+Added: common stock, net of transaction costs
+Added: Net cash provided by
+Added: (used in) financing activities
+Added: Net increase (decrease) in cash and restricted
+Added: Cash and restricted
+Added: cash at beginning of period
+Added: Cash and restricted
+Added: cash at end of period
+Added: SUPPLEMENTAL DISCLOSURE OF NON-CASH FINANCING
+Added: Recognition of operating lease right-of-use
+Added: assets and operating lease liabilities
accompanying notes to consolidated financial statements.
TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: the years ended December 31, 2022 and 2021
Organization and Business
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plan to leverage our infrastructure and expertise in these areas.
−Removed: Company was formerly incorporated in Nevada under the name Biozone Pharmaceuticals, Inc.
−Removed: On January 2, 2014,
−Removed: Biozone Pharmaceuticals, Inc.
−Removed: sold substantially all of its assets to MusclePharm Corporation (“MusclePharm”), and, on the
−Removed: same day, merged with Cocrystal Discovery, Inc.
−Removed: in a transaction accounted for as a reverse merger.
−Removed: Following the merger, the Company
−Removed: assumed Cocrystal Discovery, Inc.’s business plan and operations.
−Removed: On March 18, 2014, the Company reincorporated in Delaware under
−Removed: the name Cocrystal Pharma, Inc.
−Removed: November 25, 2014, Cocrystal Pharma, Inc.
−Removed: and affiliated entities completed a series of merger transactions as a result of which Cocrystal
−Removed: merged with RFS Pharma, LLC, a Georgia limited liability company (“RFS Pharma”).
−Removed: We refer to the surviving entity
−Removed: of this merger as “Cocrystal” or the “Company.”
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.
−Removed: Company’s activities since inception have principally consisted of acquiring product and technology rights, raising capital, and
−Removed: performing research and development.
−Removed: Successful completion of the Company’s development programs, obtaining regulatory approvals
−Removed: of its products and, ultimately, the attainment of profitable operations is dependent on future events, including, among other things,
−Removed: its ability to access potential markets, secure financing, develop a customer base, attract, retain and motivate qualified personnel,
−Removed: and develop strategic alliances.
−Removed: Through December 31, 2021, the Company has primarily funded its operations through equity offerings.
−Removed: Company has no pharmaceutical products approved for sale, has not generated any revenues to date from pharmaceutical product sales, and
−Removed: has incurred significant operating losses since inception.
−Removed: The Company has never been profitable and has incurred losses from operations
−Removed: of $ 14,185,000 and $ 9,648,000 in the years ended December 31, 2021 and 2020, respectively.
−Removed: the disease caused by SARS-CoV-2, a novel strain of coronavirus, COVID-19 continues to impact the economy of the
−Removed: and other countries around the world, we are committed to the need of antiviral therapeutics for this unprecedented challenge.
−Removed: extent to which this coronavirus impacts our business and operating results will depend on future developments that are highly uncertain
−Removed: and cannot be accurately predicted, including new information that may emerge concerning the virus, including variants of the virus,
−Removed: and the actions to contain the spread of or to detect, prevent, or treat COVID-19, among others.
−Removed: March 2020, in response to the COVID-19 pandemic, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law.
−Removed: The CARES Act provides numerous tax provisions and other stimulus measures, including temporary changes regarding the prior and future
−Removed: utilization of net operating losses, temporary changes to the prior and future limitations on interest deductions, temporary suspension
−Removed: of certain payment requirements for the employer portion of Social Security taxes, technical corrections from prior tax legislation for
−Removed: tax depreciation of certain qualified improvement property, and the creation of certain payroll tax credits associated with the retention
−Removed: of employees.
−Removed: Company’s consolidated financial statements are prepared using generally accepted accounting principles in the United States of
−Removed: America applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal
−Removed: course of business.
−Removed: The Company has incurred net losses and negative operating cash flows since inception.
−Removed: For the year ended December
−Removed: 31, 2021, the Company recorded a net loss of approximately $ 14,185,000 and used approximately $ 12,719,000 of cash in operating activities.
−Removed: December 31, 2021, the Company had cash and cash equivalents of approximately $ 58,755,000 .
−Removed: We believe that our current resources will
−Removed: be sufficient to fund our operations for the foreseeable future.
+Added: September 27, 2022, the Company filed a Certificate of Amendment to the Certificate of Incorporation (the “Amendment”) with
+Added: the Delaware Secretary of State to effect a reverse stock split of all outstanding shares of the Company’s common stock at a ratio
+Added: of one-for-12.
+Added: At the Company’s 2022 Annual Meeting of Stockholders, holders of a majority of the outstanding voting power approved
+Added: an amendment to the Certificate of Incorporation of the Company to effect a reverse stock split of all outstanding shares of our common
+Added: stock at a ratio to be determined by the Board of Directors within a range of one-for-four through one-for-12.
+Added: Following such approval,
+Added: The Board of Directors determined to effect the reverse stock split at the ratio of one-for-12.
+Added: The Amendment became effective October
+Added: 11, 2022 and the effect of the reverse stock split was reflected on the Nasdaq Stock Market.
+Added: All share and per share amounts have been retroactively restated to reflect
+Added: the one-for-12 stock split as if it occurred at the beginning of the earliest period presented.
+Added: The Company’s consolidated financial statements
+Added: are prepared using generally accepted accounting principles in the United States of America applicable to a going concern, which contemplates
+Added: the realization of assets and the satisfaction of liabilities in the normal course of business.
+Added: The Company has incurred net losses and
+Added: negative operating cash flows since inception.
+Added: For the year ended December 31, 2022, the Company recorded a net loss of approximately
+Added: $ 38,837,000 and used approximately $ 21,435,000 of cash in operating activities.
+Added: On December 31, 2022, the Company had cash and cash
+Added: equivalents of approximately $ 37,219,000 .
+Added: We believe that our current resources will be sufficient to fund our operations beyond the next
This estimate is based, in part, upon our currently projected expenditures.
−Removed: for 2022, 2023 and 2024.
−Removed: Company will need to continue obtaining adequate capital to fund operating losses until it becomes profitable.
−Removed: The Company can give no
−Removed: assurances that the additional capital it is able to raise, if any, will be sufficient to meet its needs, or that any such financing
−Removed: will be obtainable on acceptable terms.
−Removed: If the Company is unable to obtain adequate capital, it could be forced to cease operations or
−Removed: substantially curtail its drug development activities.
−Removed: The Company expects to continue incurring substantial operating losses and negative
−Removed: cash flows from operations over the next several years during its pre-clinical and clinical development phases.
+Added: The Company’s activities since inception have
+Added: principally consisted of acquiring product and technology rights, raising capital, and performing research and development.
+Added: completion of the Company’s development programs, obtaining regulatory approvals of its products and, ultimately, the attainment
+Added: of profitable operations is dependent on future events, including, among other things, its ability to access potential markets, secure
+Added: financing, develop a customer base, attract, retain and motivate qualified personnel, and develop strategic alliances.
+Added: Through December
+Added: 31, 2022, the Company has primarily funded its operations through equity offerings.
+Added: The Company will need to continue obtaining adequate capital to fund operating
+Added: losses until it becomes profitable.
+Added: The Company can give no assurances that the additional capital it is able to raise, if any, will be
+Added: sufficient to meet its needs, or that any such financing will be obtainable on acceptable terms.
+Added: Our future cash requirements, and the
+Added: timing of those requirements, will depend on a number of factors, including economic conditions, the evolving impact of the COVID-19 pandemic
+Added: on our business, the approval and success of our products in development, the continued progress of research and development of our product
+Added: candidates, the timing and outcome of clinical trials and regulatory approvals, the costs involved in preparing, filing, prosecuting,
+Added: maintaining, defending, and enforcing patent claims and other intellectual property rights, the status of competitive products, the availability
+Added: of financing, our success in developing markets for our product candidates and legal proceedings that may arise.
+Added: We have historically
+Added: not generated sustained positive cash flow and if we are not able to secure additional funding when needed, we may have to delay, reduce
+Added: the scope of, or eliminate one or more of our clinical trials or research and development programs.
+Added: If the Company is unable to obtain
+Added: adequate capital, it could be forced to cease operations or substantially curtail its drug development activities.
+Added: The Company expects
+Added: to continue incurring substantial operating losses and negative cash flows from operations over the next several years during its pre-clinical
+Added: and clinical development phases.
+Added: Additionally,
+Added: the rapid development and fluidity of the COVID-19 pandemic and new variants of the virus makes it very difficult to predict its ultimate
+Added: impact on our business, results of operations and liquidity.
+Added: The pandemic presents a significant uncertainty that could materially and
+Added: adversely affect our results of operations, financial condition and cash flows.
+Added: The combination of potential disruptions to our business
+Added: resulting from COVID-19 together with and volatile credit and capital markets could adversely impact our future liquidity, which could
+Added: have an adverse effect on our business and results of operations.
+Added: We will continue to monitor and assess the impact COVID-19 and new
+Added: variants of the virus may have on our business and financial results.
Basis of Presentation and Significant Accounting Policies
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transactions and balances have been eliminated.
−Removed: Company operates in only one segment.
−Removed: Management uses cash flows as the primary measure to manage its business and does not segment its
−Removed: business for internal reporting or decision-making.
+Added: Company operates in one segment.
+Added: In accordance with the “Segment
+Added: Reporting” Topic of the ASC, the Company’s chief operating decision makers have been identified as the Co-Chief Executive
+Added: Officers, who review operating results to make decisions about allocating resources and assessing performance for the entire Company.
+Added: Existing guidance, which is based on a management approach to segment reporting, establishes requirements to report selected segment information
+Added: quarterly and to report annually entity-wide disclosures about products and services, major customers, and the countries in which the
+Added: entity holds material assets and reports revenue.
+Added: All material operating units qualify for aggregation under “Segment Reporting”
+Added: due to their similar customer base and similarities in:
+Added: economic characteristics;
+Added: nature of products and services;
+Added: and procurement, manufacturing
+Added: and distribution processes.
+Added: Since the Company operates in one segment, all financial information required by “Segment Reporting”
+Added: can be found in the accompanying consolidated financial statements.
of the Company’s consolidated financial statements in conformance with U.S.
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accounts held at two U.S.
−Removed: financial institutions, which may, at times, exceed federally insured limits of $ 250,000
−Removed: for each institution accounts are held.
−Removed: 31, 2021 and 2020, our primary operating account held approximately $ 58,705,000
−Removed: and $ 33,010,000 ,
−Removed: respectively, and our collateral account balance of $ 50,000
−Removed: and other cash accounts are maintained at different
−Removed: institutions.
+Added: financial institutions, which may, at times, exceed federally insured limits of $ 250,000 for each institution
+Added: accounts are held.
+Added: At December 31, 2022 and 2021, our primary operating account held approximately $ 37,144,000 and $ 58,705,000 , respectively,
+Added: and our collateral account balance of $ 75,000 as of December 31, 2022 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.
16 unchanged sentences
total of the same such amounts shown in the consolidated statements of cash flows (in thousands):
−Removed: Schedule of Reconciliation of Cash And Restricted Cash
+Added: of Reconciliation of Cash and Restricted Cash
Restricted cash
−Removed: Total cash and restricted cash shown in the statements of cash flows
+Added: Total cash and restricted
+Added: cash shown in the statements of cash flows
cash represents amounts pledged as collateral for financing arrangements that are currently limited to the issuance of business credit
31 unchanged sentences
A reconciliation of the beginning and ending Level 3 liabilities for is as follows (in thousands):
−Removed: Schedule of Reconciliation of Beginning and Ending Level 3 Liabilities
−Removed: Fair Value Measurements Using
+Added: of Reconciliation of Beginning and Ending Level 3 Liabilities
+Added: Value Measurements Using
Significant Unobservable Inputs
Balance, January 1,
−Removed: Beginning balance
−Removed: Change in fair value of warrants potentially settleable in cash (Note 10)
+Added: Change in fair value
+Added: of warrants potentially settleable in cash (Note 9)
Balance at December
−Removed: Ending balance
November 2014, goodwill was recorded in connection with the acquisition of RFS Pharma.
10 unchanged sentences
of the acquired assets.
−Removed: In performing the impairment test, the Company considered, among other factors, the Company’s intention
−Removed: for future use of acquired assets, analyses of historical financial performance and estimates of future performance of Cocrystal’s
+Added: In performing an impairment test, the Company considers, among other factors, the Company’s intention for
+Added: future use of acquired assets, analyses of historical financial performance and estimates of future performance of Cocrystal’s
product candidates.
−Removed: December 31, 2021, the Company had goodwill of approximately $ 19,092,000 .
−Removed: The Company completed its annual impairment test in November
−Removed: 2021, and at that time determined the fair value of its reporting unit, under both the Company’s Nasdaq market capitalization and
−Removed: an income approach analysis;
−Removed: both methods did exceed the carrying value as of December 31, 2021;
−Removed: therefore, management did not consider
−Removed: goodwill to be impaired.
Company regularly reviews the carrying value and estimated lives of its long-lived assets, including property and equipment, to determine
16 unchanged sentences
research and development costs are expensed as incurred.
−Removed: Reclassifications
−Removed: Company has reclassified $ 273,000 of costs previously included in research and development costs in the prior year to general and administrative
−Removed: costs to conform to current year presentation.
−Removed: Company recognizes revenue from research and development arrangements.
−Removed: In accordance with Accounting Standards Codification (“ASC”)
−Removed: Topic 606– Revenue from Contracts with Customers (“Topic 606”), revenue is recognized when a customer obtains
−Removed: control of promised goods or services.
−Removed: The amount of revenue recognized reflects the consideration to which the Company expects to be
−Removed: entitled to receive in exchange for these goods and services.
−Removed: January 2, 2019, the Company entered into an Exclusive License and Research Collaboration Agreement (the “Collaboration Agreement”)
−Removed: with Merck Sharp & Dohme Corp.
−Removed: (“Merck”) to discover and develop certain proprietary influenza A/B antiviral agents.
−Removed: Under the terms of the Collaboration Agreement, Merck will fund research and development for the program, including clinical development,
−Removed: and will be responsible for worldwide commercialization of any products derived from the collaboration.
−Removed: During the year ended December
−Removed: 31, 2021 the Company did not recognize revenue for research and development activities related to its influenza A/B program or for program
−Removed: expense reimbursements.
−Removed: During the year ended December 31, 2020 the Company recognized revenue of $ 2,014,000 as consideration in exchange
−Removed: for conveyance of intellectual property rights at the signing of the agreement, $ 1,779,000 for research and development activities related
−Removed: to its influenza A/B program and $ 235,000 for program expense reimbursements.
+Added: Research and development costs are presented net of tax credits.
+Added: Company’s Australian subsidiary is entitled to receive government assistance in the form of refundable and non-refundable
+Added: research and development tax credits from the federal and provincial taxation authorities, based on qualifying expenditures incurred
+Added: during the fiscal year.
+Added: The refundable credits are from the provincial taxation authorities and are not dependent on its ongoing tax
+Added: status or tax position and accordingly are not considered part of income taxes.
+Added: The Company records refundable tax credits as a
+Added: reduction of research and development expenses when the Company can reasonably estimate the amounts and it is more likely than not,
+Added: they will be received.
+Added: During the year ended December 31, 2022, the Company recorded tax credits of $ 805,000 as
+Added: a reduction of research and development expense , of which approximately $ 716,000
+Added: was recorded as tax credit receivable as of the year then ended.
Company accounts for income taxes under the asset and liability method.
17 unchanged sentences
related to income taxes as part of its income tax expense.
−Removed: Company recognizes compensation expense using a fair value-based method for costs related to stock-based payments, including stock options.
−Removed: 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
−Removed: as expense over the requisite service period on a straight-line basis.
−Removed: of the Black-Scholes option pricing model requires the input of subjective assumptions including expected volatility, expected term,
−Removed: and a risk-free interest rate.
−Removed: The Company estimates volatility using a blend of its own historical stock price volatility as well as
−Removed: that of market comparable entities since the Company’s common stock has limited trading history and limited observable volatility
−Removed: The expected term of the options is estimated by using the Securities and Exchange Commission Staff Bulletin No.
−Removed: Simplified Method for Estimate Expected Term .
−Removed: The risk-free interest rate is estimated using comparable published federal funds
+Added: Company periodically issues stock-based compensation to officers, directors, and consultants for services rendered.
+Added: Such issuances vest
+Added: and expire according to terms established at the issuance date.
+Added: payments to employees, directors, and for acquiring goods and services from nonemployees, which include grants of employee stock options,
+Added: are recognized in the financial statements based on their grant date fair values in accordance with ASC 718, Compensation-Stock Compensation.
+Added: Stock option grants to employees, which are generally time vested, are measured at the grant date fair value and depending on the conditions
+Added: associated with the vesting of the award, compensation cost is recognized on a straight-line or graded basis over the vesting period.
+Added: Recognition of compensation expense for non-employees is in the same period and manner as if the Company had paid cash for the services.
+Added: The fair value of stock options granted is estimated using the Black-Scholes option-pricing model, which uses certain assumptions related
+Added: to risk-free interest rates, expected volatility, expected life, and future dividends.
+Added: The assumptions used in the Black-Scholes option
+Added: pricing model could materially affect compensation expense recorded in future periods.
Stock Purchase Warrants and Other Derivative Financial Instruments
5 unchanged sentences
or give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement).
−Removed: classification of our common stock purchase warrants and other freestanding derivatives at each reporting date to determine whether a
−Removed: change in classification between assets and liabilities is required.
+Added: the classification of our common stock purchase warrants and other freestanding derivatives at each reporting date to determine whether
+Added: a change in classification between assets and liabilities is required.
Income (Loss) per Share
9 unchanged sentences
their inclusion would be anti-dilutive (in thousands):
−Removed: Schedule of Antidilutive Securities Excluded from Calculations of Net Loss Per Share
−Removed: Outstanding options to purchase common stock
−Removed: Warrants to purchase common stock
+Added: of Antidilutive Securities Excluded from Calculations of Net Loss Per Share
+Added: Outstanding options to purchase
+Added: Warrants to purchase
Accounting Pronouncements
3 unchanged sentences
2016-13, Credit Losses - Measurement of Credit Losses on Financial Instruments (“ASC 326”).
−Removed: The standard significantly changes how entities will measure credit losses for most financial assets, including accounts and notes receivables.
+Added: The standard significantly changes how entities will measure credit losses for most financial assets, including accounts and notes receivable.
The standard will replace today’s “incurred loss” approach with an “expected loss” model, under which companies
21 unchanged sentences
settlement assessment by removing the requirements to (i) consider whether the contract would be settled in registered shares, (ii) consider
−Removed: whether collateral is required to be posted, and (iii) assess shareholder rights.
+Added: whether collateral is required to be posted, and (iii) assess stockholder rights.
ASU 2020-06 is effective for fiscal years beginning
8 unchanged sentences
the Company’s consolidated financial statements and related disclosures.
+Added: Foreign Currency Remeasurement
+Added: dollar has been determined to be the functional currency for the net
+Added: assets of Cocrystal Australia operations.
+Added: The transactions are recorded in the local currencies and are remeasured at each reporting date
+Added: using the historical rates for nonmonetary assets and liabilities and current exchange rates for monetary assets and liabilities at the
+Added: balance sheet date.
+Added: Exchange gains and losses from the remeasurement of monetary assets and liabilities are recognized in other income
+Added: The Company recognized an income (loss) of approximately $ ( 18,161 ) and $ ( 8,631 ) for the years ended December 31, 2022 and 2021,
+Added: respectively.
+Added: of December 31, 2022 and 2021, the Company’s cash balances consisted of the following (in thousands):
+Added: of Cash Balance
+Added: Australian Dollars
Property and Equipment
and equipment as of December 31, consists of the following (table in thousands):
−Removed: Schedule of Property and Equipment
−Removed: Lab equipment (excluding equipment under finance leases)
−Removed: Finance lease right-of-use lab equipment obtained in exchange for finance lease liabilities, net
−Removed: Computer and office equipment
+Added: of Property and Equipment
+Added: Lab equipment (excluding equipment
+Added: under finance leases)
+Added: Finance lease right-of-use lab equipment obtained
+Added: in exchange for finance lease liabilities, net
+Added: Computer and office
Total property and equipment
Less accumulated depreciation
−Removed: Property and equipment, net
+Added: Property and equipment,
expense was $ 185,000 and $ 190,000 for the years ended December 31, 2022 and 2021, respectively.
−Removed: December 31, 2021 and 2020, the Company had goodwill of $ 19,092,000 .
−Removed: The Company performs an annual impairment test on November 30 th
−Removed: to determine the fair value of its reporting unit, measured by the Company’s Nasdaq market capitalization and an income approach
−Removed: Based on management’s impairment test at November 30, 2021, there was no impairment of goodwill.
+Added: Company completed its annual impairment test in November 2021, and at that time determined the fair value of its reporting unit, as determined
+Added: utilizing both the Company’s Nasdaq market capitalization and an income approach analysis;
+Added: exceeded the carrying value of the reporting
+Added: unit as of December 31, 2021;
+Added: therefore, management did not consider the $ 19,092,000 of goodwill to be impaired.
+Added: Company uses judgement in assessing whether assets may have become impaired between annual impairment tests.
+Added: The occurrence of a
+Added: change in circumstances, such as a continued decline in the market capitalization of the Company, would determine the need for
+Added: impairment testing between annual impairment tests.
+Added: During the six months ended June 30, 2022, the Company saw a significant
+Added: decrease in its price of common stock resulting in an overall reduction in market capitalization and our recorded net book value
+Added: exceeded our market capitalization as of June 30, 2022.
+Added: Pre-impairment, the carrying value of the reporting unit exceeded the market
+Added: capitalization of the Company at June 30, 2022 and management concluded that goodwill was impaired in its entirety and recorded a
+Added: non-cash impairment.
+Added: of December 31, 2022, the Company had no remaining goodwill.
Accounts Payable and Accrued Expenses
payable and accrued expenses consisted of the following as of December 31, (table in thousands):
−Removed: Schedule of Accounts Payable and Accrued Expenses
+Added: of Accounts Payable and Accrued Expenses
Accounts payable
1 unchanged sentence
Accrued other expenses
−Removed: Total accounts payable and accrued expenses
+Added: Total accounts payable
+Added: and accrued expenses
payable and accrued other expenses contain unpaid general and administrative expenses and costs related to research and development that
2 unchanged sentences
The Company had approximately
−Removed: 97,469,000 and 70,439,000 shares issued and outstanding as of December 31, 2021 and 2020, respectively.
+Added: 8,143,000 shares issued and outstanding as of December 31, 2022 and 2021, respectively.
holders of common stock are entitled to one vote for each share of common stock held.
−Removed: January, February, March, August and November 2020, the Company closed a series of placements of its common stock resulting in the sale
−Removed: of 35,288,697 shares of its common stock for net proceeds after transaction costs of approximately $ 35.8 million.
Company was a party to the At-The-Market Offering Agreement, dated July 1, 2020 (“ATM Agreement”) with H.C.
Co., LLC (“Wainwright”), pursuant to which the Company may issue and sell over time and from time to time, to or through
−Removed: Wainwright, up to $ 10,000,000
−Removed: of shares of the Company’s
−Removed: common stock.
−Removed: During January 2021, the Company sold
−Removed: shares of its common stock pursuant to the ATM
−Removed: Agreement for net proceeds of approximately $ 2,072,000 .
−Removed: There were no sales under the ATM Agreement during the remainder of 2021.
+Added: Wainwright, up to $ 10,000,000 of shares of the Company’s common stock.
+Added: January 2021, the Company sold 85,834 shares of its common stock pursuant to the ATM Agreement for net proceeds of approximately $ 2.1
+Added: There were no sales under the ATM Agreement during the remainder of 2021 or 2022.
May 4, 2021, the Company entered into an underwriting agreement with H.C.
7 unchanged sentences
Incentive Plans
−Removed: Company adopted an equity incentive plan in 2007 (the “2007 Plan”) under which 1,786,635 shares of common stock have been
−Removed: reserved for issuance to employees and nonemployee directors and consultants of the Company.
−Removed: Recipients of incentive stock options granted
−Removed: 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
−Removed: the fair market value of such stock on the date of grant.
−Removed: The maximum term of options granted under the 2007 Plan is ten years .
−Removed: generally vest 25% after one year, with the remaining balance vesting monthly over the following three years .
−Removed: As of December 31, 2021,
−Removed: all future options available under the 2007 plan have expired and no options remain available for future grant under this plan.
+Added: Company adopted an equity incentive plan in 2007 (the “2007 Plan”).
+Added: The 2007 Plan has expired, and the Company no longer
+Added: issues any awards under the 2007 Plan.
+Added: As of December 31, 2022, there are 424 outstanding incentive stock options granted under the 2007
+Added: Plan that are eligible to purchase shares of the Company’s common stock.
+Added: The maximum term of options granted under the 2007 Plan
+Added: was ten years.
Company adopted a second equity Incentive plan in 2015 (the “2015 Plan”) under which 833,333 shares of common stock have
−Removed: been reserved for issuance to employees, and nonemployee directors and consultants of the Company.
+Added: been reserved for issuance to employees, and non-employee directors and consultants of the Company.
Recipients of incentive stock options
5 unchanged sentences
As of December 31, 2022, approximately 483,833 million options remain available for future grant under the 2015 Plan.
−Removed: following table summarizes stock option transactions for the 2007 Plan and 2015 Plan, collectively, for the year ended December 31, 2021
+Added: following table summarizes stock option transactions for the 2007 Plan and 2015 Plan, collectively, for the years ended December 31,
2022 and 2021 (table in thousands, except per share amounts):
−Removed: of Share-based Compensation, Stock Options, Activity
+Added: Schedule of Share-based Compensation, Stock Options, Activity
Balance at December 31, 2020
+Added: Increase in authorized options
Balance at December 31, 2021
4 unchanged sentences
The options have an exercise price of $ 5.04 per share, expire in ten years , and vest as follows:
−Removed: one half vests on the one-year anniversary of the grant date and the remainder will vest in eight equal quarterly increments with the
−Removed: first such quarterly increment vesting on September 30, 2021 .
+Added: half vests on the one-year anniversary of the grant date and the remainder will vest in eight equal quarterly increments with the first
+Added: such quarterly increment vesting on September 30, 2022.
The total fair value of these options at the grant date was approximately $ 633,000
using the Black-Scholes Option pricing model.
−Removed: The Black-Scholes option pricing model includes the following weighted average
−Removed: assumptions for grants made during the year ended December 31, 2021:
−Removed: of Weighted Average Assumptions Used for Grants
+Added: The Black-Scholes option pricing model includes the following weighted average assumptions
+Added: for grants made during the year ended December 31, 2022:
+Added: Schedule of Weighted Average Assumptions Used for Grants
Weighted average per share grant date fair value
10 unchanged sentences
using the Black-Scholes Option pricing model.
−Removed: The Company did not grant any stock options during the year ended December 31, 2019.
−Removed: Black-Scholes option pricing model includes the following weighted average assumptions for grants made during the year ended December
+Added: The Black-Scholes option pricing model includes the following weighted average assumptions
+Added: for grants made during the year ended December 31, 2021:
Weighted average per share grant date fair value
3 unchanged sentences
Expected terms (in years)
−Removed: Company accounts for share-based awards to employees and nonemployee directors and consultants in accordance with the provisions of ASC
−Removed: 718, Compensation—Stock Compensation.
−Removed: , and under the recently issued guidance following FASB’s pronouncement, ASU
−Removed: 2018-07, Compensation—Stock Compensation (Topic 718):
−Removed: Improvements to Nonemployee Share-Based Payment Accounting .
−Removed: 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
−Removed: over the requisite service, or vesting, period.
−Removed: The Company values its equity awards using the Black-Scholes option pricing model, and
−Removed: accounts for forfeitures when they occur.
−Removed: For the years ended December 31, 2021 and 2020, equity-based compensation expense recorded
−Removed: was $ 724,00 and $ 662,000 , respectively.
+Added: the years ended December 31, 2022 and 2021, equity-based compensation expense for options vesting during the period was $ 855,000 and
+Added: $ 724,000 , respectively.
of December 31, 2022, there was $ 1,052,000 of total unrecognized compensation expense related to non-vested stock options that is expected
5 unchanged sentences
totaled 140,359 , with an aggregate intrinsic value of $ 0.00 .
−Removed: These options had a weighted-average exercise price of $ 3.05 per share and
−Removed: a weighted-average remaining contractual term of 6.4 years at December 31, 2021.
+Added: These options had a weighted-average exercise price of $ 26.53 per share
+Added: and a weighted-average remaining contractual term of 7.2 years at December 31, 2022.
aggregate intrinsic value of outstanding and exercisable options at December 31, 2022 was calculated based on the closing price of the
5 unchanged sentences
following table presents information concerning common stock available for future issuance as of December 31, (in thousands):
−Removed: of Common Stock Reserved for Future Issuance
+Added: Schedule of Common Stock Reserved for Future Issuance
Stock options issued and outstanding
3 unchanged sentences
December 31, 2022 and 2021 (table in thousands):
−Removed: of Warrant Activity
−Removed: Warrants Accounted for as:
+Added: Summary of Warrant Activity
Accounted for as:
+Added: Accounted for as:
Outstanding, December 31, 2020
2 unchanged sentences
Expiration date
−Removed: consist of equity-classified warrants and warrants with the potential to be settled in cash, which are liability-classified warrants.
−Removed: As of December 31, 2021, and 2020, 159,000 warrants are accounted for as liabilities and 84,000 warrants are accounted for as equity.
−Removed: Classified as Equity
−Removed: Equity-classified
−Removed: 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
−Removed: expiration, irrespective of the market price.
−Removed: These purchase warrants are not attached to any debt or equity instruments, thus considered
−Removed: freestanding, and there are no circumstances under ASC 815 that require the warrants to be classified as liabilities or as derivatives.
−Removed: Thus, our May 2018 warrants are classified as equity, and their value are carried in the additional paid-in capital account in the stockholders’
−Removed: equity section of the balance sheet.
−Removed: warrants were granted to the underwriters and investment brokers for services provided related to the Company’s May 2018 equity
−Removed: 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
−Removed: from the commencement date of October 27, 2018.
+Added: outstanding as of December 31, 2022 and 2021 included warrants with the potential to be settled in cash, which are liability-classified
+Added: As of December 31, 2021, 13,268 warrants are accounted for as liabilities and 6,732 warrants are accounted for as equity.
+Added: the year ended December 31, 2022, the 6,732 warrants accounted as equity expired and the 13,268 warrants accounted for as liabilities
+Added: remained outstanding as of December 31, 2022.
Classified as Liabilities
10 unchanged sentences
using the Black-Scholes option-pricing model with the following inputs as of December 31, 2022:
−Removed: of Fair Value of Warrants Classified as Liabilities
+Added: Schedule of Fair Value of Warrants Classified as Liabilities
Expected dividend yield
29 unchanged sentences
prior to the first commercial sale of the first product developed under the Collaboration Agreement, in its sole discretion, without
−Removed: The Company continues working with Merck under this Collaboration Agreement.
−Removed: Company recognized revenue for the years ended December 31, 2021 and 2020 of $ 0 and $ 2,014,000 , respectively.
−Removed: As of December 31, 2021
−Removed: and 2020, accounts receivable of $ 0 and $ 556,000 was due from Merck, respectively.
+Added: The Company continues working with Merck under this Collaboration Agreement as of the years then ended.
+Added: Company did not recognize revenue for the years ended December 31, 2022 and 2021 As of December 31, 2022 and 2021, the Company did not
+Added: report accounts receivable from Merck.
State University Research Foundation
25 unchanged sentences
to customary terms.
+Added: 2a Clinical Trial
+Added: August 3, 2022 the Company engaged hVIVO, a subsidiary of London-based Open Orphan plc (AIM:
+Added: ORPH), a rapidly growing specialist
+Added: contract research organization (CRO), to conduct a Phase 2a clinical trial with the Company’s novel, broad-spectrum, orally
+Added: administered antiviral influenza candidate.
+Added: The Company paid a reservation fee of $ 1.7
+Added: million upon execution of the agreement for a Phase 2a clinical trial that is scheduled to begin in 2023, which has been recorded under prepaid expenses
+Added: and other current assets on the accompanying December 31,2022 balance sheet.
+Added: The total estimated cost of the agreement (including the reservation fee) is
+Added: approximately $ 7.2
accordance with the authoritative guidance for income taxes under ASC 740, a deferred tax asset or liability is determined based on the
15 unchanged sentences
Deferred tax assets:
−Removed: Net operating loss carryforwards (i)(ii)
−Removed: Research and development tax credits (iii)
+Added: Net operating
+Added: loss carryforwards
+Added: Research and development
+Added: Capitalized and Research
Total deferred tax assets
3 unchanged sentences
Total deferred taxes, net
−Removed: Valuation allowance
−Removed: Deferred tax liability, net
+Added: Deferred tax liability,
Company has established a valuation allowance against net deferred tax assets due to the uncertainty that such assets will be realized.
40 unchanged sentences
Goodwill impairment
+Added: Research credits
Change in valuation allowance
17 unchanged sentences
of Components of Rent Expense and Supplemental Cash Flow Information
−Removed: Operating lease cost (included in operating expenses in the Company’s consolidated statement of operations)
+Added: Operating lease cost (included
+Added: in operating expenses in the Company’s consolidated statement of operations)
Other Information
−Removed: Cash paid for amounts included in the measurement of lease liabilities
−Removed: Weighted average remaining lease term – operating leases (in years)
+Added: Cash paid for amounts included in the measurement
+Added: of lease liabilities
+Added: Weighted average remaining lease term –
+Added: operating leases (in years)
Average discount rate – operating leases
1 unchanged sentence
of Supplemental Balance Sheet Information
−Removed: At December 31,
−Removed: At December 31,
Operating leases
−Removed: Long-term right-of-use assets of which $ 153 relates to related party, net of amortization of $ 527
−Removed: Short-term operating lease liabilities, of which $ 53 relates to related party
−Removed: Long-term operating lease liabilities, of which $ 101 relates to related party
−Removed: Total operating lease liabilities
+Added: right-of-use assets of which $ 99 and $ 153 relates to related party, net of accumulated amortization of $ 592 and $ 388
+Added: Short-term operating lease liabilities, of
+Added: which $ 59 and $ 53 relates to related party
+Added: Long-term operating
+Added: lease liabilities, of which $ 42 and $ 101 relates to related party
+Added: Total operating lease
of Maturities of Lease Liabilities
−Removed: Year ending December 31,
−Removed: (in thousands)
2025 and thereafter
Total minimum operating lease payments
−Removed: present value discount
−Removed: Total operating lease liabilities
+Added: present value
+Added: Total operating lease
minimum lease payments above do not include common area maintenance (CAM) charges, which are contractual obligations under the Company’s
6 unchanged sentences
Phillip Frost, a director,
−Removed: and a principal shareholder of the Company for the lease of its Miami office (see Note 13 – Transactions with Related Parties).
+Added: and a principal stockholder 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
8 unchanged sentences
The lease agreements have an effective interest rate
−Removed: minimum finance lease payments, by year and in aggregate, are as follows:
−Removed: of Maturities of Finance Lease
−Removed: Year ending December 31,
−Removed: (in thousands)
−Removed: 2024 and thereafter
−Removed: Total minimum capital lease payments
leased lab equipment is included under property and equipment and depreciable over five years .
4 unchanged sentences
Commitments and Contingencies
−Removed: Contingencies
time to time, the Company is a party to, or otherwise involved in, legal proceedings arising in the normal course of business.
2 unchanged sentences
Insurance Underwriters Inc.
−Removed: filed suit against us in federal court in Delaware seeking a declaratory judgment that there was no insurance
−Removed: coverage for any settlement, judgment, or defense costs in the class and derivative litigation, that the monies totaling approximately
−Removed: million it paid to the Company in connection
−Removed: with the SEC investigation were not covered by insurance, and for recoupment of the monies already paid.
−Removed: We have retained counsel to
−Removed: defend us which has filed an answer to the complaint denying its material allegations, as well as a counterclaim against Liberty for
−Removed: breach of contract, declaratory judgment, bad faith and violation of the Washington State Consumer Protection Act, alleging among other
−Removed: things that Liberty wrongfully denied the Company’s claims for coverage of the class and derivative litigations, and seeking money
−Removed: Liberty Insurance Underwriters, Inc.
−Removed: filed suit against us in federal court in Delaware seeking a declaratory judgement that
−Removed: there was no insurance coverage for any settlement, judgement, or defense costs in the class and derivative litigation, the monies totaling
−Removed: approximately $ 1 million it paid to the Company in connection with the SEC request for information in an investigation was not covered
−Removed: by insurance, and for the recoupment of the monies already paid.
−Removed: The case has been set for trial in July, 2022.
+Added: filed suit against us in federal court in Delaware
+Added: seeking a declaratory judgment that there was no insurance coverage for any settlement, judgment, or defense costs in the class and derivative
+Added: litigation, that the monies totaling approximately $ 1 million it paid to the Company in connection with the SEC investigation were not
+Added: covered by insurance, and for recoupment of the monies already paid.
+Added: We have retained counsel to defend us which has filed an answer to
+Added: the complaint denying its material allegations, as well as a counterclaim against Liberty for breach of contract, declaratory judgment,
+Added: bad faith and violation of the Washington State Consumer Protection Act, alleging among other things that Liberty wrongfully denied the
+Added: Company’s claims for coverage of the class and derivative litigations, and seeking money damages.
+Added: Liberty Insurance Underwriters,
+Added: filed suit against us in federal court in Delaware seeking a declaratory judgement that there was no insurance coverage for any settlement,
+Added: judgement, or defense costs in the class and derivative litigation, the monies totaling approximately $ 1 million it paid to the Company
+Added: in connection with the SEC request for information in an investigation was not covered by insurance, and for the recoupment of the monies
+Added: already paid.
+Added: On June 7, 2022, the court filed a Stipulation and Order for Entry of Judgment in the amount of $ 1,359,063.72 in favor of
+Added: Liberty (the “Judgment”) following summary judgment granted by the court to Liberty on all but one of the matters at issue
+Added: The Company filed an appeal in July 2022.
+Added: Pending the outcome of the appeal, the Company paid $ 1.6 million into the registry
+Added: of the court which stayed execution of the Judgment.
+Added: The United States Court of Appeals for the Third Circuit (the “Third Circuit
+Added: Court”) held oral argument on the appeal on March 8, 2023.
+Added: As of the date of this Report, the Third Circuit Court has not issued
+Added: a ruling on the appeal.
November 2017, Lee Pederson, a former Biozone lawyer, filed a lawsuit in the U.S.
18 unchanged sentences
In Pederson II, Mr.
−Removed: Pederson seeks damages in the amount of $ 800,000
−Removed: or such other amount as may be determined at
−Removed: Pederson II had previously been stayed by the court, pending disposition of Pederson I.
−Removed: With that first lawsuit having been dismissed
−Removed: and appeal denied, the stay was lifted in Pederson II, and the Company and all other defendants in that case filed Motions to Dismiss
−Removed: the (then amended) complaint.
−Removed: On November 19, 2020 the Magistrate Judge recommended dismissal of Pederson II, and further recommended
−Removed: that Pederson be restricted from filing any other actions in the District of Minnesota against defendants on the same or similar allegations
−Removed: as those in Pederson II, and on January 4, 2021 the District Court Judge adopted those recommendations and ordered dismissal of Pederson
−Removed: On February 1, 2021 Pederson filed a Notice of Appeal from the order of dismissal of Pederson II in the Eighth Circuit, and on
−Removed: December 29, 2021 the Eighth Circuit affirmed the decision of the District Court.
−Removed: Thereafter, on or about January 11, 2022 Pederson sought
−Removed: via petition, re-hearing en banc by the Eighth Circuit, which petition remains pending.
−Removed: May 19, 2020, A.G.P./Alliance Global Partners (“AGP”), which had previously acted as the Company’s underwriter, placement
−Removed: agent and sales agent in connection with the Company’s registered and exempt equity offerings, filed a lawsuit against the Company
−Removed: in the United States District Court for the Southern District of New York alleging violation of a lock-up provision under the Placement
−Removed: Agent Agreement, dated January 28, 2020 (the “Placement Agent Agreement”), by and between the Company and AGP.
−Removed: (i) damages estimated in the complaint to be in excess of $ 1
−Removed: million and attorneys’ fees, and (ii) declaratory
−Removed: In August 2021, the Company settled the lawsuit filed against it by AGP.
−Removed: Following the Company’s negotiated payment,
−Removed: the lawsuit was dismissed with prejudice.
−Removed: the Company intends to defend itself vigorously from the claims in the aforementioned disputes, it is unable to predict the outcome of
−Removed: these legal proceedings.
−Removed: Any potential loss as a result of these legal proceedings cannot be reasonably estimated.
−Removed: As a result, the Company
−Removed: has not recorded a loss contingency for any of the aforementioned claims.
−Removed: administrative and finance activities are fully functional out of our Miami, Florida location and our research laboratory in Bothell,
−Removed: Washington remains open for essential operations while meeting COVID-19 quarantine challenges.
−Removed: Our scientists are also able to continue
−Removed: working remotely and we remain committed to meeting our corporate and development milestones throughout the year.
−Removed: We have experienced
−Removed: delays in our supply chain and with service partners as a result of the COVID-19 pandemic, including recent raw material and test animal
−Removed: shortages affecting our research and development efforts.
−Removed: Also because of the unknown impact from the COVID-19 pandemic, it may have
−Removed: unanticipated material adverse effects on us in a number of ways including:
+Added: Pederson seeks damages in the amount of $ 800,000 or such other amount as may be determined at trial.
+Added: had previously been stayed by the court, pending disposition of Pederson I.
+Added: With that first lawsuit having been dismissed and appeal
+Added: denied, the stay was lifted in Pederson II, and the Company and all other defendants in that case filed Motions to Dismiss the (then
+Added: amended) complaint.
+Added: On November 19, 2020 the Magistrate Judge recommended dismissal of Pederson II, and further recommended that Pederson
+Added: be restricted from filing any other actions in the District of Minnesota against defendants on the same or similar allegations as those
+Added: in Pederson II, and on January 4, 2021 the District Court Judge adopted those recommendations and ordered dismissal of Pederson II.
+Added: February 1, 2021 Pederson filed a Notice of Appeal from the order of dismissal of Pederson II in the Eighth Circuit, and on December
+Added: 29, 2021 the Eighth Circuit affirmed the decision of the District Court.
+Added: Thereafter, on or about January 11, 2022 Pederson sought via
+Added: petition, re-hearing en banc by the Eighth Circuit.
+Added: On October 3, 2022, the U.S.
+Added: Supreme Court
+Added: denied Pederson’s petition for a writ of certiorari.
+Added: administrative and finance activities are fully functional out of our Miami,
+Added: Florida location and our research laboratory in Bothell, Washington remained open for essential operations while meeting COVID-19 quarantine
+Added: Our scientists are also able to continue working remotely and we remain committed to meeting our corporate and development
+Added: milestones throughout the year.
+Added: We have experienced delays in our supply chain and with service partners as a result of the COVID-19 pandemic,
+Added: including recent raw material and test animal shortages affecting our research and development efforts.
+Added: Also because of the unknown impact
+Added: from COVID-19, it may have unanticipated material adverse effects on us in a number of ways including:
our scientists and other personnel (or their family members) are infected with the virus, it may hamper our ability to engage in
1 unchanged sentence
we rely on third parties who have been and may in the future be adversely impacted;
−Removed: these third parties are and/or continue to be adversely affected by COVID-19, they may focus on other activities which they
−Removed: may devote their limited time to other priorities rather than to our joint research, which has caused and may in the future cause
−Removed: material delays in our research and development efforts;
+Added: these third parties are and/or continue to be adversely affected by COVID-19, they may focus on other activities which they may devote
+Added: their limited time to other priorities rather than to our joint research, which has caused and may in the future cause material delays
+Added: in our research and development efforts;
have experienced and may experience in the future shortages of laboratory materials and other resources which impact our research
a result of the continuing impact of the virus, we may fail to get access to third party laboratories which would impact our research
−Removed: addition to the problems described above, we
−Removed: may sustain problems due to the serious short-term and possible longer term serious economic disruptions as our economy faces unprecedented
+Added: addition to the problems described above, we may sustain problems due to the serious short-term and possible longer term serious
+Added: economic disruptions as our economy faces unprecedented uncertainty.
Transactions with Related Parties
September 2018, the Company leased administrative offices from a limited liability company owned by one of the Company’s directors
−Removed: and principal shareholder, Dr.
+Added: and principal stockholder, Dr.
Phillip Frost.
−Removed: The lease term is three
−Removed: years with an optional three-year extension.
−Removed: an annualized basis, rent expense, including taxes and fees, for this location would be approximately $ 62,000 .
+Added: The lease term is three years with an optional three-year extension.
+Added: On an annualized basis,
+Added: rent expense, including taxes and fees, for this location would be approximately $ 62,000 .
The Company paid a lease deposit of $ 4,000
−Removed: and total rent and other expenses paid in connection
−Removed: with this lease were $ 60,000
−Removed: for the years ended December 31, 2021
−Removed: and 2020 respectively.
+Added: and total rent and other expenses paid in connection with this lease were $ 61,000 and $ 60,000 for the years ended December 31, 2022 and
+Added: 2021 respectively.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosures
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.