−Removed: Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
−Removed: common stock is traded on The Nasdaq Capital Market (“Nasdaq”) under the symbol “COCP”.
+Added: Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
+Added: common stock is traded on The Nasdaq Capital Market (“Nasdaq”) under the symbol “COCP”.
As of March 23,
2022, there were approximately 434 holders of record of our common stock.
−Removed: have not declared nor paid any cash dividend on our common stock, and we currently intend to retain future earnings, if any, to
−Removed: finance the expansion of our business, and we do not expect to pay any cash dividends in the foreseeable future.
−Removed: whether to pay cash dividends on our common stock will be made by our board of directors, in their discretion, and will depend
−Removed: on our financial condition, results of operations, capital requirements and other factors that our board of directors considers
−Removed: Our ability to pay cash dividends is governed by applicable provisions of Delaware law.
+Added: have not declared nor paid any cash dividend on our common stock, and we currently intend to retain future earnings, if any, to finance
+Added: the expansion of our business, and we do not expect to pay any cash dividends in the foreseeable future.
+Added: The decision whether to pay
+Added: cash dividends on our common stock will be made by our board of directors, in their discretion, and will depend on our financial condition,
+Added: results of operations, capital requirements and other factors that our board of directors considers significant.
+Added: Our ability to pay cash
+Added: dividends is governed by applicable provisions of Delaware law.
sales of equity securities
−Removed: unregistered sales of our equity securities during the period covered by this Annual Report on Form 10-K have been previously
+Added: unregistered sales of our equity securities during the period covered by this Annual Report on Form 10-K have been previously reported.
Selected Financial Data
−Removed: a smaller reporting company as defined in Rule 12b-2 of the Exchange Act, we are not required to include information otherwise
−Removed: required by this item.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations
−Removed: following discussion and analysis should be read in conjunction with the Consolidated Financial Statements included elsewhere
−Removed: in this report.
−Removed: develop novel medicines for use in the treatment of human viral diseases.
−Removed: Cocrystal has been developing novel technologies and
−Removed: approaches to create first-in-class and best-in-class antiviral drug candidates since 2008.
−Removed: Our focus is to pursue the development
−Removed: and commercialization of broad-spectrum antiviral drug candidates that will transform the treatment and prophylaxis of viral diseases
−Removed: By concentrating our research and development efforts on viral replication inhibitors, we plan to leverage our infrastructure
−Removed: and expertise in these areas.
−Removed: fiscal year ended December 31, 2020, the following key aspects of our business advanced:
−Removed: entered into two license and collaboration agreements with KSURF to further discover and develop certain proprietary broad-spectrum
−Removed: antiviral compounds.
−Removed: selected lead compound CDI-45205 for further development against coronavirus.
−Removed: received $2,102,000 from Merck in payments under the Collaboration Agreement.
−Removed: raised a total of $35,783,000 in net proceeds from common-stock only public financings.
−Removed: settled the previously disclosed class action and three related derivative actions.
−Removed: See “Part I.
−Removed: Legal Proceedings”
−Removed: for more information on these legal proceedings and the settlement.
−Removed: influenza A preclinical lead, showed excellent preclinical antiviral activity against influenza A strains, including avian
−Removed: pandemic strains, oseltamivir-resistant, baloxavir-resistant strains, and has a favorable pharmacokinetic profile.
−Removed: currently conducting the remaining preclinical IND enabling activities and plan to initiate a Phase 1 study during 2021.
−Removed: completed all research obligations under the Merck exclusive worldwide license and collaboration agreement, and Merck is now
−Removed: solely responsible for further development of the influenza A/B antiviral compounds that were discovered using Cocrystal’s
−Removed: unique structure-based technologies and Nobel Prize-winning expertise.
−Removed: of Operations
−Removed: Operating Loss and Net Loss
−Removed: stated above, we are focused on research and development of novel medicines for use in the treatment of human viral diseases.
−Removed: We had revenue of $2,014,000 and $6,564,000 for the years ended December 31, 2020 and 2019, respectively.
−Removed: The decrease resulted
−Removed: primarily from the receipt in January 2019 of the upfront payment of $4,000,000 under the Collaboration Agreement.
−Removed: For the years
−Removed: ended December 31, 2020 and 2019 our revenues consisted of collaboration revenue, including payments for research and development
−Removed: activities related to our influenza A/B program and program expense reimbursements, under our Collaboration Agreement with Merck.
−Removed: For the year ended December 31, 2019, the collaboration revenue also included consideration in exchange for conveyance of intellectual
−Removed: property rights at the signing of the agreement.
−Removed: We do not expect to generate any revenues in 2021, except to the extent we receive
−Removed: any milestone payments under our Collaboration Agreement.
−Removed: We had a net loss of $9,648,000 for the year ended December 31, 2020,
−Removed: compared to a net loss of $48,169,000 for the year ended December 31, 2019.
−Removed: The decrease was primarily due to a $46,103,000 goodwill
−Removed: impairment charge recorded for the year ended December 31, 2019.
−Removed: Our operating loss for the year ended December 31, 2020 was $9,586,000
−Removed: compared to an operating loss of $48,406,000 in 2019.
−Removed: The operating loss for 2019 included the non-cash impairment charge of $46,103,000
−Removed: on our intangible goodwill asset.
−Removed: and Development Expense
−Removed: and development expenses consist primarily of compensation-related costs for our eight employees dedicated to research and development
−Removed: activities and for our Scientific Advisory Board members, as well as lab supplies, lab services, and facilities and equipment
−Removed: research and development expenses were $6,307,000 for the year ended December 31, 2020, compared with $4,004,000 for the year
−Removed: ended December 31, 2019.
−Removed: This year over year decrease in research and development expenditures was primarily due to the completion
−Removed: of our HCV phase 2 clinical trial and expense reimbursements resulting from our Collaboration Agreement with Merck.
−Removed: research and development expenses to increase in 2021 due to advancing our coronavirus and norovirus programs.
−Removed: and Administrative Expense
−Removed: and administrative expense includes compensation-related costs for our employees dedicated to general and administrative activities,
−Removed: legal fees, audit and tax fees, consultants and professional services, and general corporate expenses.
−Removed: and administrative expenses were $5,293,000 for the year ended December 31, 2020, compared with $4,863,000 for the year ended
−Removed: December 31, 2019.
−Removed: This increase of $430,000 was primarily due to professional fees associated with litigation matters and insurance
−Removed: We anticipate professional fees will be reduced in the second quarter of 2021 as a result of settling the class
−Removed: action litigation discussed in Part I.
−Removed: Legal Proceedings within this Form 10-K.
−Removed: the ordinary course of business, the Company entered into non-cancelable related party leases for its facilities (see Note 13
−Removed: Transactions with Related Parties in the following Consolidated Financial Statements).
−Removed: Income/Expense
−Removed: expense was $8,000 for the year ended December 31, 2020, compared to $19,000 for the year ended December 31, 2019.
−Removed: expense in 2020 and 2019 is related to lease agreements.
−Removed: Income/Expense
−Removed: income (expense), net, was ($62,000) for the year ended December 31, 2020 compared with $237,000 for the year ended December 31,
−Removed: Other income (expense), net for the year ended December 31, 2020 and 2019 primarily consisted of a loss of ($54,000) and
−Removed: a gain of $256,000, respectively, recognized from decreases and increases in the fair value of our derivative liabilities as our
−Removed: stock price fluctuated.
−Removed: Under accounting principles generally accepted in the United States, we record other income or expense
−Removed: for the change in fair value of our outstanding warrants that are accounted for as liabilities during each reporting period.
−Removed: the value of the warrants decreases during a period, which occurred during the year ended December 31, 2020, we record other income.
−Removed: The fair value of our outstanding warrants is inversely related to the fair value of the underlying common stock;
−Removed: as such, a decrease
−Removed: in the fair value of our common stock during a given period generally results in other income while an increase in the fair value
−Removed: of our common stock generally results in other expense.
−Removed: and Capital Resources
−Removed: the year ended December 31, 2020, net cash used in operating activities was $9,830,000, compared to net cash used in operating
−Removed: activities of $1,563,000 for the year ended December 31, 2019.
−Removed: The increase in cash used in operating activities in 2020 as compared
−Removed: to 2019 was attributable to the reduction of revenue flow from our influenza A/B Collaboration Agreement with Merck by $4,550,000.
−Removed: the year ended December 31, 2020, net cash used in investing activities netted to $240,000, which consisted of capital expenditures
−Removed: for lab equipment, software, and networking for our Lab located in Bothell, Washington.
−Removed: For the year ended December 31, 2019,
−Removed: our net cash used in investing activities consisted of $145,000.
−Removed: the year ended December 31, 2020, net cash provided by financing activities was $35,662,000, compared to net cash provided by
−Removed: financing activities of $6,424,000 for the year ended December 31, 2019.
−Removed: Net cash generated by financing activities in 2020 and
−Removed: 2019 was the result of issuance common stock, net of finance lease payments.
−Removed: Company had approximately $33.5 million cash on hand on March 15, 2021.
−Removed: We expect that this cash balance will be sufficient to
−Removed: support the Company’s working capital needs for at least the next 21 months.
−Removed: pharmaceutical products, including conducting preclinical studies and clinical trials, is capital-intensive.
−Removed: As a rule, research
−Removed: and development expenses increase substantially as a company advances a product candidate toward clinical programs.
−Removed: Historically,
−Removed: we financed our operations with the proceeds from public and private equity and debt offerings, including additional investments
−Removed: by certain existing stockholders, and entered into strategic partnerships and collaborations for the research, development and
−Removed: commercialization of product candidates.
−Removed: We currently have one hepatitis C product candidate that has completed a Phase 2a clinical
−Removed: trial and have secured funding of the research and development of influenza A/B product candidates under our Collaboration Agreement
−Removed: Additionally, we expect that in the long term in case of successful development and commercialization of one or more
−Removed: influenza A/B antiviral agents under the Collaboration Agreement we will be eligible to receive certain milestone payments up
−Removed: to a total of $156 million, including payments associated with the successful product development and attainment of certain U.S.
−Removed: and EU regulatory approvals for the developed products and sales volume and royalties on net sales of the products.
−Removed: See “Item
−Removed: Business –
−Removed: Collaborations –
−Removed: Merck Collaboration.”
−Removed: However, in order to conduct research and development
−Removed: of our other product candidates, including our potential COVID-19 therapy, we may need to raise additional capital to support
−Removed: our operations or form partnerships, in addition to our existing collaborative alliances.
−Removed: Such funding or partnerships may not
−Removed: be available to us on acceptable terms, or at all.
−Removed: addition, as we advance our Coronavirus program we expect that we will be required to make certain milestone payments of up to
−Removed: approximately $7.3 million to KSURF under our two license agreements with KSURF.
−Removed: See “Item 1 –
−Removed: Business –
−Removed: Collaborations
−Removed: Kansas State University Research Foundation”
−Removed: for more information about these license agreements.
−Removed: have raised a total of $35,783,000 in net proceeds from common-stock only public financings during the year ended December 31,
−Removed: Set forth below is a brief summary of each such financing.
−Removed: January 29, 2020, the Company entered into a securities purchase agreement with certain institutional investors, pursuant to which
−Removed: the Company agreed to sell and issue, in a registered direct offering, 3,492,063 of the Company’s shares of common stock,
−Removed: par value $0.001 at a purchase price per share of $0.63 for aggregate net proceeds to the Company of approximately $1,500,000,
−Removed: after deducting fees payable to the placement agent and other estimated offering expenses payable by the Company.
−Removed: closed the offering on January 31, 2020.
−Removed: February 27, 2020, the Company entered into a securities purchase agreement with certain institutional investors, pursuant to
−Removed: which the Company agreed to sell and issue, in a registered direct offering, 8,461,540 of the Company’s shares of common
−Removed: stock, par value $0.001 at a purchase price per share of $1.30 for aggregate net proceeds to the Company of approximately $10,100,000,
−Removed: after deducting fees payable to the placement agent and other estimated offering expenses payable by the Company.
−Removed: closed the offering on February 28, 2020.
−Removed: March 9, 2020, the Company entered into a securities purchase agreement with certain institutional investors, pursuant to which
−Removed: the Company agreed to sell and issue, in a registered direct offering, 5,037,038 of the Company’s shares of common stock,
−Removed: par value $0.001 at a purchase price per share of $1.35 for aggregate net proceeds to the Company of approximately $5,000,000,
−Removed: after deducting fees payable to the placement agent and other estimated offering expenses payable by the Company.
−Removed: closed the offering on March 10, 2020.
−Removed: July 1, 2020, the Company entered into an At-The-Market Offering Agreement (“ATM”) with H.C.
−Removed: Wainwright & Co.,
−Removed: 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 of shares of the Company’s common stock.
−Removed: We have sold 2,905,243 shares of common stock under
−Removed: the ATM and received net proceeds of approximately $5,693,000.
−Removed: August 31, 2020, the Company closed an underwritten public offering of its common stock totaling 16,422,813 shares at public offering
−Removed: price of $1.05 per share sold to Wainwright for net proceeds of approximately $15.6 million, after deducting underwriting discounts
−Removed: and commissions and offering expenses payable by the Company.
−Removed: The 16,422,813 shares of common stock sold in the offering includes
−Removed: 2,137,098 shares pursuant to Wainwright’s partial exercise of its over-allotment option to purchase additional shares of
−Removed: common stock, pursuant to the Amended and Restated Underwriting Agreement, dated as of August 26, 2020, between the Company and
−Removed: Company’s consolidated financial statements are prepared using generally accepted accounting principles in the United States
−Removed: of America applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in
−Removed: the normal course of business.
−Removed: The Company has incurred net losses and negative operating cash flows since inception.
−Removed: year ended December 31, 2020, the Company recorded a net loss of approximately $9,648,000 and used approximately $9,830,000 of
−Removed: cash in operating activities.
−Removed: Note Regarding Forward Looking Statements
−Removed: Annual Report includes forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995,
−Removed: including statements regarding our plans for the future development of preclinical and clinical drug candidates, our expectations
−Removed: regarding future characteristics of the product candidates we develop, the expected time of achieving certain value driving milestones
−Removed: in our programs, including the planned initiation of the Phase 1 Influenza A study in the third quarter of 2021, the expected
−Removed: development of additional COVID-19 replication inhibitors in 2021, the anticipated completion of proof-of-concept animal study
−Removed: in our norovirus program in the first half of 2021, our expectations with respect to HCV market opportunity and our plans regarding
−Removed: further clinical development of CC-31244, the expected future results of our collaboration with Merck pursuant to the Collaboration
−Removed: Agreement, including potential receipt of milestone payments and royalties, our expectations related to our collaborations with
−Removed: KSURF, HitGen and InterX, our expectations regarding future operating results, statement regarding the suitability and adequacy
−Removed: of our properties, anticipated payments under the license agreements with KSURF, and our future liquidity.
−Removed: words “believe,”
−Removed: “may,”
−Removed: “estimate,”
−Removed: “continue,”
−Removed: “anticipate,”
−Removed: “intend,”
−Removed: “should,”
−Removed: “plan,”
−Removed: “could,”
−Removed: “target,”
−Removed: “potential,”
−Removed: “is likely,”
−Removed: “will,”
−Removed: “expect”
−Removed: and similar expressions, as they relate to us, are intended to identify forward-looking
−Removed: We have based these forward-looking statements largely on our current expectations and projections about future events
−Removed: and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial
−Removed: results anticipated by any or all of these forward-looking statements might not occur.
−Removed: Important factors, uncertainties and risks
−Removed: that may cause actual results to differ materially from these forward-looking statements include the risks and uncertainties
−Removed: arising from the impact of the COVID-19 pandemic on our Company, our partners, and on the national and global economy, including
−Removed: supply chain disruptions and other business interruptions, our ability to proceed with our programs, our continued collaboration
−Removed: with Merck and achievement by Merck of certain milestones under the Collaboration Agreement, our ability to successfully identify,
−Removed: enter into and maintain additional strategic collaborations for further development of our product candidates, financial difficulties
−Removed: experienced by certain partners, future results of planned research and, if successful, clinical trials, general risks
−Removed: arising from clinical trials, receipt of regulatory approvals, development of effective treatments and/or vaccines by competitors,
−Removed: including as part of the programs financed by the U.S.
−Removed: government, and any additional costs related to unfavorable future outcome
−Removed: of pending litigation or any unanticipated claims.
−Removed: Further information on such uncertainties and risks is contained in the
−Removed: “Risk Factors”
−Removed: in Item 1A of this this Annual Report.
−Removed: We undertake no obligation to publicly update or revise any
−Removed: forward-looking statements, whether as the result of new information, future events or otherwise.
−Removed: For more information regarding
−Removed: some of the ongoing risks and uncertainties of our business, see “Item 1A –
−Removed: Risk Factors”
−Removed: and our other filings
−Removed: with the SEC.
−Removed: Accounting Policies and Estimates
−Removed: management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial
−Removed: statements, which have been prepared in accordance with U.S.
−Removed: Generally Accepted Accounting Principles, or GAAP.
−Removed: The preparation
−Removed: of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets,
−Removed: liabilities and expenses.
−Removed: On an ongoing basis, we evaluate these estimates and judgments, including those described below.
−Removed: base our estimates on our historical experience and on various other assumptions that we believe to be reasonable under the circumstances.
−Removed: These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities that are
−Removed: not readily apparent from other sources.
−Removed: Actual results and experiences may differ materially from these estimates.
−Removed: significant accounting policies are more fully described in the accompanying notes to the consolidated financial statements included
−Removed: in this Annual Report on Form 10-K for the year ended December 31, 2020, we believe that the following accounting policies are
−Removed: the most critical to aid you in fully understanding and evaluating our reported financial results and affect the more significant
−Removed: judgments and estimates that we use in the preparation of our consolidated financial statements.
−Removed: account for stock options related to our equity incentive plans under the provisions of Financial Accounting Standards Board (“FASB”)
−Removed: Accounting Standards Codification (“ASC”) 718 which requires the recognition of the fair value of stock-based compensation.
−Removed: The fair value of stock options is estimated using a Black-Scholes option valuation model.
−Removed: This model requires the input of subjective
−Removed: assumptions including expected stock price volatility, expected life and estimated forfeitures of each award.
−Removed: The fair value of
−Removed: equity-based awards is amortized ratably over the requisite service period of the award.
−Removed: Due to the limited amount of historical
−Removed: data available to us, particularly with respect to stock-price volatility, employee exercise patterns and forfeitures, actual
−Removed: results could differ from our assumptions.
−Removed: Value of Warrants
−Removed: are recorded either as equity instruments or derivative liabilities.
−Removed: In the case of warrants recorded as liabilities, they are
−Removed: recorded at their estimated fair value at the date of issuance.
−Removed: Subsequent changes in estimated fair value are recorded in other
−Removed: income (expense) in the Company’s statement of operations in each subsequent period.
−Removed: The warrants are measured at estimated
−Removed: fair value using the Black Scholes valuation model, which is based, in part, upon inputs for which there is little or no observable
−Removed: market data, requiring the Company to develop its own assumptions.
−Removed: Inherent in this model are assumptions related to expected
−Removed: stock price volatility, expected life, risk-free interest rate and dividend yield.
−Removed: We estimate the volatility of our common stock
−Removed: at the date of issuance, and at each subsequent reporting period, based on a combination of the historical implied volatility
−Removed: of our own stock price and that of a group of comparable companies, that matches the expected remaining life of the warrants.
−Removed: The risk-free interest rate is based on the U.S.
−Removed: Treasury zero-coupon yield curve on the measurement date for a maturity similar
−Removed: to the expected remaining life of the warrants.
−Removed: The expected life of the warrants is assumed to be equivalent to their remaining
−Removed: contractual term.
−Removed: The dividend rate is based on our historical rate, which we anticipate to remain at zero.
−Removed: The assumptions used
−Removed: in calculating the estimated fair value of the warrants represent our best estimates.
−Removed: However, these estimates involve inherent
−Removed: uncertainties and the application of management judgment.
−Removed: As a result, if factors change and different assumptions are used, the
−Removed: warrant liability and the change in estimated fair value could be materially different.
−Removed: recorded $65,195,000 of goodwill in the RFS Pharma acquisition in 2014 that is subject to impairment testing.
−Removed: This goodwill primarily
−Removed: represents the amount initially recorded as a deferred tax liability in the RFS Pharma acquisition, which was required as the
−Removed: goodwill recorded for book purposes is not tax deductible based on the structure of the acquisition.
−Removed: Impairment tests of goodwill
−Removed: are done annually on November 30 requiring substantial judgment and estimates.
−Removed: We completed our annual goodwill impairment tests
−Removed: for November 30, 2019 and determined that there was a $46,103,000 impairment of goodwill.
−Removed: There was no impairment of goodwill
−Removed: based on our testing on November 30, 2020.
−Removed: Issued Accounting Standards
−Removed: discussion in Note 2 to the consolidated financial statements.
−Removed: Quantitative and Qualitative Disclosures About Market Risk
+Added: a smaller reporting company as defined in Rule 12b-2 of the Exchange Act, we are not required to include information otherwise required
+Added: by this item.
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.