Clinical Trials and Product Development - The company completed a Phase 2a clinical trial for its lead oral candidate CC-42344 in 2023 and a COVID-19 clinical trial for CDI-988, with findings expected to be reported in 2024[132]. - The company advanced its Influenza A product candidate to a Phase 2a trial and initiated a Phase 1 trial for its COVID-19 product candidate in 2023[232]. - The company’s COVID-19 programs are in early clinical stages, and the risk of competition from established companies poses a significant threat to its future prospects[158]. - Approximately 70% of drugs proceed past Phase 1 studies, 33% past Phase 2, and only 25%-30% reach Phase 4 in the FDA approval process, highlighting the challenges in product development[175]. - The company has limited experience in conducting and managing preclinical development activities and clinical trials necessary for obtaining marketing approvals[204]. - Adverse events observed during clinical trials could lead to interruptions or halts in trials, negatively impacting regulatory approval[223]. - The company may face significant costs and delays if additional clinical trials are required or if results are negative or inconclusive[196]. Financial Performance and Capital Needs - The company has an accumulated deficit of $315,914,000 from inception through December 31, 2023, and anticipates continuing to incur losses in the future[133]. - The company does not expect to generate revenue from product sales for at least four years due to the lengthy and costly regulatory approval processes[132]. - The company has historically not generated sustained positive cash flow and expects to continue incurring substantial operating losses during its development phases[301]. - The company may need to raise additional capital or form strategic partnerships to support ongoing research and development activities[136]. - The company recognized a loss of approximately $65,000 for the year ended December 31, 2023, compared to a loss of $18,000 in 2022, indicating a significant increase in losses[316]. Regulatory and Compliance Challenges - The company may face challenges in maintaining compliance with regulatory standards, which could delay clinical trials and approval processes[150]. - Regulatory approval is crucial for revenue generation, and any delays or failures in obtaining such approvals could severely impact operations[191]. - The company must monitor and report adverse events and maintain compliance with FDA regulations post-approval[199]. - The company must comply with various healthcare fraud and abuse laws, and failure to do so could result in significant penalties and reputational harm[280]. Competition and Market Dynamics - The company faces intense competition in the COVID-19 treatment market, which could hinder its ability to gain market share[158]. - The company faces significant competition from other biotechnology and pharmaceutical companies, which could adversely affect its operating results[216]. - The company may face competition from larger pharmaceutical firms with greater resources, impacting its ability to develop and commercialize product candidates[264]. - The company is in early clinical development stages and must compete with established products, relying on regulatory approvals and clinical efficacy to succeed[243]. Intellectual Property and Legal Risks - The company may be unable to acquire or in-license necessary third-party intellectual property rights, which could hinder its development efforts[228]. - The company’s ability to commercialize products may be threatened if its patent applications fail to issue or are challenged by third parties[234]. - The company faces potential litigation regarding intellectual property rights, which could lead to substantial costs and operational distractions if unsuccessful[240]. - The company may face litigation related to patent infringement, which could be costly and time-consuming[239]. Operational and Management Considerations - The company relies on third-party manufacturers and CROs for research and development, which may lead to delays and increased costs if these parties encounter issues[145][147]. - The company relies on third-party manufacturers for clinical and commercial supplies, exposing it to risks such as supply chain shortages and manufacturing quality issues[166]. - The company has 12 full-time employees as of March 28, 2024, and plans to expand its workforce to support growth, which may pose management challenges[260]. - The company is dependent on key personnel, and the loss of these individuals could adversely impact its objectives[279]. Market Acceptance and Pricing Pressures - Market acceptance of product candidates will depend on third-party payor coverage and reimbursement policies, which are critical for new product acceptance[270]. - The company faces challenges in obtaining coverage and reimbursement for its products, with no uniform policy among third-party payors in the U.S.[271]. - The company may experience pricing pressures due to proposed legislative changes allowing Medicare to negotiate drug prices, potentially impacting future operations[253]. - Legislative proposals for a "Medicare-like" public option could limit price increases and affect the company's pricing strategies[273]. Cybersecurity and Technology Risks - Cybersecurity threats pose risks to the company's proprietary technology and information systems, which are essential for operations and research[266]. Financial Instruments and Stock Performance - The balance of common stock purchase warrants and other derivative financial instruments as of December 31, 2023, included 558 total options outstanding, with a weighted average exercise price of $10.57[321]. - The company has experienced significant stock price volatility, with a reverse stock split on October 22, 2022, to meet Nasdaq's minimum bid price requirement[287]. - The carrying amounts of financial assets and liabilities, such as cash and accounts payable, approximate their fair values due to their short-term nature as of December 31, 2023[307].

Financial Performance - The net loss for 2023 was $18.0 million, or $1.87 per share, compared to a net loss of $38.8 million, or $4.77 per share, in 2022 [14]. - Net loss for 2023 was $17,984 thousand, an improvement from a net loss of $38,837 thousand in 2022, indicating a reduction of approximately 53.7% [24]. - The loss per share improved from $4.77 in 2022 to $1.87 in 2023, a decrease of about 60.8% [24]. - Total operating expenses decreased from $38,829 thousand in 2022 to $18,559 thousand in 2023, a reduction of approximately 52.2% [24]. Research and Development - Research and development (R&D) expenses for 2023 were $15.2 million, an increase from $12.4 million in 2022, primarily due to advancing influenza candidate CC-42344 into a Phase 2a study and the dual norovirus-coronavirus candidate CDI-988 into a Phase 1 study [12]. - Research and development expenses rose to $15,169 thousand in 2023, up from $12,392 thousand in 2022, reflecting an increase of about 22.5% [24]. - Topline data is expected in 2024 from the ongoing Phase 2a human challenge study with oral CC-42344 and the Phase 1 study with oral CDI-988 [4]. - The company plans to initiate a Phase 1 study in 2024 with inhaled CC-42344 as a potential treatment and prophylactic for influenza A [3]. - The company expects to begin a Phase 1 clinical study with inhaled CC-42344 in Australia in 2024 [8]. Cash and Assets - Cocrystal reported unrestricted cash of $26.4 million as of December 31, 2023, down from $37.1 million as of December 31, 2022 [15]. - Cocrystal's cash position is believed to be sufficient to fund current operations and planned clinical studies beyond the next 12 months [3]. - Cash reserves decreased from $37,144 thousand in 2022 to $26,353 thousand in 2023, a decline of approximately 29.0% [22]. - Total current assets decreased from $40,178 thousand in 2022 to $29,091 thousand in 2023, a decline of approximately 27.6% [22]. - Total stockholders' equity fell from $39,567 thousand in 2022 to $26,384 thousand in 2023, a decrease of about 33.3% [22]. Liabilities and Legal Matters - Total liabilities increased significantly from $1,273 thousand in 2022 to $4,875 thousand in 2023, representing a growth of about 282.5% [22]. - Cocrystal received $2.6 million related to litigation with an insurer in 2023, including a $1.6 million refund and a $1.0 million settlement [13]. - Legal settlement expenses showed a significant change, with a cost of $2,600 thousand in 2023 compared to a gain of $1,600 thousand in 2022 [24]. Market Insights - The global COVID-19 therapeutics market is estimated to exceed $16 billion by the end of 2031, driven by the emergence of new variants [8]. - Approximately 1 billion cases of seasonal influenza occur worldwide each year, resulting in direct costs of about $10.4 billion for hospitalizations and outpatient visits in the U.S. [6].

Feedback provides greater clarity on regulatory requirements for planned Phase 2b trial BOTHELL, Wash., March 19, 2024 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (NASDAQ:COCP) ("Cocrystal" or the "Company") announces it has received Pre-Investigational New Drug (Pre-IND) feedback from the U.S. Food and Drug Administration (FDA) regarding CC-42344 as a potential oral treatment for pandemic and seasonal influenza A. A Pre-IND review provides the opportunity to obtain FDA guidance and clarification on critical ...

Financial Performance - Net loss for the nine months ended September 30, 2023, was $13,520,000, compared to a net loss of $34,336,000 for the same period in 2022, reflecting a significant reduction in losses[167] - Net cash used in operating activities was $11,340,000 for the nine months ended September 30, 2023, down from $16,542,000 in the same period in 2022[168] - The company reported no impairment for the nine months ended September 30, 2023, compared to a non-cash impairment expense of $19,092,000 in the same period of 2022[151] Research and Development - Total research and development expenses for the nine months ended September 30, 2023, were $10,902,000, an increase of $1,797,000 compared to $9,105,000 for the same period in 2022[149] - Research and development efforts are focused on three areas, including the CC-42344 Phase 2a clinical trial for pandemic and seasonal influenza A[154] - The company has initiated a Phase 1 clinical trial for CDI-988, with dosing of the first subjects announced in September 2023[157] Administrative Expenses - General and administrative expenses for the nine months ended September 30, 2023, were $4,591,000, a slight increase of $61,000 from $4,530,000 in 2022[163] Financial Position - The company had $29,738,000 in unrestricted cash as of September 30, 2023, sufficient to maintain planned operations for more than the next 12 months[179] - The company raised $4,000,000 in a private placement sale of 2,030,458 shares of common stock on April 4, 2023[169] - The fair value of outstanding warrants resulted in no change for the nine months ended September 30, 2023, compared to a change of $12,000 in the same period of 2022[164]

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except per share data) 1. Organization and Business Segments Level 2 — other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement date. Use of the Black-Scholes option pricing model requires the input of subjective assumptions including expected volatility, expected term, and a risk-free interest rate. The Company estimates volatility using a blend of its own historical ...

In September 2021, the Company opened a wholly owned foreign subsidiary in Australia named Cocrystal Pharma Australia, Ltd ("Cocrystal Australia") with the objective of operating clinical trials in Australia. All share and per share amounts have been retroactively restated to reflect the one-for-12 stock split as if it occurred at the beginning of the earliest period presented. Basis of Presentation Cocrystal Australia maintains its records in Australian dollars. The monetary assets and liabilities of Cocry ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Cocrystal Pharma, Inc. (Exact name of registrant as specified in its charter) Delaware 35-2528215 (State or Other Jurisdiction of (I.R.S. Employer Incorporation or Organization) Identification No.) 19805 North Creek Parkway Bothell, WA 98011 (Address of Principal Executive Of ice) (Zip Code) Registrant's telephone number, including area code: (305) 42 ...

C@CRYSTAL Potent antivirals to combat some of the most serious diseases facing humanity November 2022 Nasdaq: COCP www.cocrystalpharma.com 2 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the market opportunities for the treatment of acute and chronic viral diseases which are the focus of our programs; the development pipeline; our technology platform's ability to produce viable drug candidates ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☐ Title of Each Class Trading Symbol(s) Name of each exchange on which registered Common Stock COCP The Nasdaq Stock Market LLC (The Nasdaq Capital Market) FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSIT ...

C@CRYSTAL Potent antivirals to combat some of the most serious diseases facing humanity October 2022 Nasdaq: COCP www.cocrystalpharma.com 2 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the market opportunities for the treatment of acute and chronic viral diseases which are the focus of our programs; the development pipeline; our technology platform's ability to produce viable drug candidates a ...