BOTHELL, Wash., July 10, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that its first-in-class pan-viral protease inhibitor CDI-988 has been selected for an oral presentation at the 9th International Calicivirus Conference being held September 7-11, 2025 in Banff, Alberta, Canada. Sam Lee, PhD, the Company’s President and co-CEO, will present “Oral Direct-Acting Antiviral CDI-988 for Norovirus Infection Prevention and Treatment: Mechanism of Action and Phase 1 Study Results” on Se ...

Core Viewpoint - Cocrystal Pharma, Inc. is presenting its broad-spectrum protease inhibitor CDI-988 at the 2025 Military Health System Research Symposium, highlighting its potential as a prophylaxis and treatment for norovirus, which currently lacks approved antiviral agents or vaccines [1][2]. Company Overview - Cocrystal Pharma, Inc. is a clinical-stage biotechnology company focused on discovering and developing novel antiviral therapeutics targeting the replication processes of various viruses, including noroviruses, coronaviruses, and hepatitis C viruses [6]. - The company utilizes unique structure-based technologies and expertise in enzymology and medicinal chemistry to create first- and best-in-class antiviral drugs [6]. Product Development - CDI-988 is designed as a broad-spectrum inhibitor targeting a highly conserved region in the active site of 3CL viral proteases, representing a first-in-class oral treatment for noroviruses and coronaviruses [3]. - The company has completed a Phase 1 study evaluating the safety, tolerability, and pharmacokinetics of CDI-988 in healthy adults, which included a food effect cohort [3]. Technology Platform - Cocrystal's proprietary structure-based platform technology provides a three-dimensional structure of inhibitor complexes at near-atomic resolution, facilitating the identification of novel binding sites and rapid structural information processing [4]. - The goal of this technology is to develop antiviral therapies that are safe, well-tolerated, and effective against all viral subtypes, with a high barrier to viral resistance [4]. Industry Context - The Military Health System Research Symposium is an annual event that gathers military medical care providers, researchers, and industry representatives to discuss healthcare initiatives related to military infectious diseases and operational medicine [5].

Core Viewpoint - Cocrystal Pharma, Inc. has announced that its novel influenza PB2 inhibitor CC-42344 demonstrates strong antiviral activity against the highly pathogenic H5N1 avian influenza strain, indicating potential for treating both pandemic and seasonal influenza infections [1][3][4] Company Summary - Cocrystal Pharma is a clinical-stage biotechnology company focused on discovering and developing antiviral therapeutics targeting the replication processes of various viruses, including influenza and coronaviruses [7] - The company employs structure-based technologies and expertise to create first- and best-in-class antiviral drugs [7] Product Development - CC-42344 is an investigational drug candidate that binds to a conserved active site of the PB2 protein, inhibiting viral replication [2][3] - The virology study showed that CC-42344 has an EC50 of 0.003 µM against the H5N1 strain, making it approximately 1,000-fold more potent than Tamiflu, which has an EC50 of 2.69 µM [3][8] - Initial data from the development of CC-42344 indicates a favorable safety and tolerability profile [3][4] Market Potential - The influenza market is valued in the multibillion-dollar range, with influenza responsible for an estimated $11.2 billion in direct and indirect costs annually in the U.S. [4] - On average, about 8% of the U.S. population contracts influenza each season, highlighting the significant public health concern [4] Industry Context - The emergence of highly pathogenic avian influenza strains poses a risk of adaptation for human-to-human transmission, raising concerns about potential influenza pandemics [2][5] - Recent studies indicate extremely low population immunity to H5N1 viruses in the U.S., suggesting a vulnerability to outbreaks [6]

Core Insights - Cocrystal Pharma, Inc. will participate in a fireside chat at the Noble Capital Markets' 2025 Emerging Growth Virtual Equity Conference on June 5, 2025 [1] - The company is a clinical-stage biotechnology firm focused on developing antiviral therapeutics targeting various viruses [3] Company Overview - Cocrystal Pharma specializes in discovering and developing novel antiviral drugs aimed at noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2), and hepatitis C viruses [3] - The company utilizes unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral therapeutics [3] Event Details - Registered investors can request one-on-one meetings with Cocrystal management through the conference registration platform [2] - A video webcast of the presentation will be available approximately 48 hours after the event and archived for 90 days on the company's website and Channelchek [2]

Financial Performance - Net loss for Q1 2025 was $2.3 million, or $0.23 per share, compared to a net loss of $4.0 million, or $0.39 per share, in Q1 2024[13] - Total operating expenses decreased to $2,341 million in Q1 2025 from $4,158 million in Q1 2024, representing a reduction of 43.7%[23] - Net loss narrowed to $2,301 million in Q1 2025 compared to a net loss of $3,956 million in Q1 2024, reflecting an improvement of 42%[23] - Net loss per common share improved to $(0.23) in Q1 2025 from $(0.39) in Q1 2024, a reduction of 41%[23] Expenses - Research and development (R&D) expenses for Q1 2025 were $1.4 million, down from $3.0 million in Q1 2024, primarily due to reduced personnel costs and clinical study timing[12] - General and administrative (G&A) expenses for Q1 2025 were $1.0 million, compared to $1.2 million in Q1 2024, mainly due to lower insurance costs[12] - Research and development expenses were $1,360 million in Q1 2025, down from $2,950 million in Q1 2024, a decrease of 53.9%[23] Cash and Assets - Unrestricted cash as of March 31, 2025, was $6.9 million, down from $9.9 million as of December 31, 2024[14] - Cocrystal's total assets as of March 31, 2025, were $10.7 million, down from $13.5 million as of December 31, 2024[21] Market and Product Development - Cocrystal's oral pan-viral protease inhibitor CDI-988 has shown superior broad-spectrum antiviral activity against GII.17 strains, the most prevalent strain in the U.S. and Europe for 2024-2025[15] - The global COVID-19 therapeutics market is projected to exceed $16 billion annually by the end of 2031[11] - Cocrystal is preparing to launch a U.S. human challenge study for CDI-988, a critical step in advancing this therapy[2] - The company reported favorable safety and tolerability results from the Phase 1 study of CDI-988, with plans to report topline results in Q2 2025[15] Other Financial Metrics - Interest income increased to $37 million in Q1 2025 from $220 million in Q1 2024, indicating a significant decline[23] - Foreign exchange gain was $3 million in Q1 2025, compared to a loss of $(18) million in Q1 2024, showing a positive turnaround[23] - The weighted average number of common shares remained constant at 10,174 million for both Q1 2025 and Q1 2024[23] Norovirus Impact - The annual burden of norovirus in the U.S. is estimated at $10.6 billion, with noroviruses responsible for approximately 21 million cases annually[8]

Antiviral Development - Cocrystal Pharma is focused on developing antiviral therapeutics for norovirus, coronavirus, and influenza, utilizing structure-based technologies[91] - The company has received authorization for a Phase 2a human challenge study with oral CC-42344 for influenza A, completing enrollment of 78 subjects[97] - CC-42344 demonstrated excellent in vitro antiviral activity against various influenza A strains, including those resistant to Tamiflu® and Xofluza®[95] - CDI-988, a novel protease inhibitor, is being evaluated for safety and tolerability in a Phase 1 study, with favorable results reported from single-ascending dose cohorts[101][103] - Noroviruses cause an estimated 21 million cases of acute gastroenteritis annually in the U.S., with no effective treatment currently available[108] - The company is developing broad-spectrum influenza antivirals targeting replication enzymes of seasonal and pandemic influenza A and B strains[100] - Cocrystal Pharma's research and development efforts are primarily focused on addressing unmet medical needs in viral diseases[93] - The global HCV market is significant, with an estimated 58 million people having chronic HCV infections, and the company aims to develop ultra-short treatment regimens of four to six weeks[116][117] - CC-31244 is a potential best-in-class pan-genotypic inhibitor for HCV, with favorable safety results from previous studies and ongoing efforts to find a partner for further development[118][119] Financial Performance - Total research and development expenses decreased from $2,950,000 in Q1 2024 to $1,360,000 in Q1 2025, a reduction of approximately 54%[121] - General and administrative expenses decreased from $1,208,000 in Q1 2024 to $981,000 in Q1 2025, a reduction of about 19%[123] - Net loss for Q1 2025 was $2,301,000, compared to a net loss of $3,956,000 in Q1 2024, representing a decrease in loss of approximately 42%[127] - Net cash used in operating activities decreased from $4,503,000 in Q1 2024 to $2,939,000 in Q1 2025, a reduction of about 35%[128] - The company had $6,921,000 in unrestricted cash as of March 31, 2025, which is expected to be insufficient to cover working capital needs for the next 12 months[131] - Interest income decreased from $220,000 in Q1 2024 to $37,000 in Q1 2025, a decline of approximately 83%[124] - Foreign exchange gain of $3,000 was recorded in Q1 2025, compared to a foreign exchange loss of $18,000 in Q1 2024[125] - No cash was used for investing activities in Q1 2025, compared to $8,000 used in Q1 2024[129] - The company has not achieved annual profitability since inception and continues to incur operating losses[133] - The company intends to fund future operations through additional private or public equity offerings and strategic partnerships[136] Study Protocol and Adjustments - The company is in discussions to potentially amend the Phase 2a study protocol for CC-42344 due to low influenza infection rates among participants[98]

Core Viewpoint - Cocrystal Pharma is advancing its antiviral product pipeline, particularly focusing on CDI-988, a novel oral pan-viral protease inhibitor targeting norovirus and coronaviruses, with promising in vitro results and plans for human challenge studies [2][9][10]. Antiviral Product Pipeline Overview - The company utilizes a structure-based drug discovery platform to develop broad-spectrum antivirals that target conserved regions of viral enzymes, enhancing efficacy against mutations and reducing side effects [3]. - CDI-988 has shown superior antiviral activity against major norovirus strains, including GII.17 and GII.4, and is positioned as a first-in-class treatment [2][9]. Influenza Programs - Influenza poses a significant global health threat, with approximately 1 billion cases and up to 650,000 deaths annually [4]. - Cocrystal's CC-42344, a PB2 inhibitor, has demonstrated excellent in vitro activity against various influenza A strains, including those resistant to existing antivirals [4][8]. Norovirus Program - Norovirus is responsible for an estimated 21 million cases in the U.S. annually, leading to significant healthcare costs and hospitalizations [6]. - There is currently no effective treatment or vaccine for norovirus, highlighting the potential market opportunity for CDI-988 [5][6]. SARS-CoV-2 and Other Coronavirus Program - CDI-988 has shown potent in vitro activity against SARS-CoV-2 and other coronaviruses, with the global COVID-19 therapeutics market projected to exceed $16 billion annually by 2031 [7]. Financial Results - For Q1 2025, research and development expenses were $1.4 million, down from $3.0 million in Q1 2024, primarily due to reduced personnel costs [11]. - The net loss for Q1 2025 was $2.3 million, or $0.23 per share, compared to a net loss of $4.0 million, or $0.39 per share, in Q1 2024 [12]. - As of March 31, 2025, the company reported unrestricted cash of $6.9 million, down from $9.9 million at the end of 2024 [13].

Core Insights - Cocrystal Pharma's investigational drug candidate CDI-988 demonstrates strong binding and potency against the GII.17 protease, similar to its effectiveness against GII.4 norovirus variants, which have been the dominant strains until recently [1][2] - The company plans to initiate a human norovirus challenge study in 2025 to evaluate CDI-988 for the prevention and treatment of norovirus infections [1][6] Company Overview - Cocrystal Pharma, Inc. is a clinical-stage biotechnology company focused on developing novel antiviral therapeutics targeting noroviruses, influenza viruses, coronaviruses, and hepatitis C viruses [5] - The company utilizes unique structure-based technologies and expertise in structural biology to create first- and best-in-class antiviral drugs [5] Product Development - CDI-988 is a pan-viral protease inhibitor designed for broad-spectrum antiviral activity against noroviruses and coronaviruses, with a novel mechanism of action [3][4] - A Phase 1 study has been completed, showing favorable safety and tolerability for CDI-988 in healthy adults [3][6] Market Context - Norovirus is the leading cause of acute gastroenteritis globally, with an estimated 685 million cases and around 50,000 child deaths annually, resulting in a societal cost of approximately $60 billion [2] - The emergence of GII.17 variants has led to increased norovirus outbreaks in the U.S. and Europe [6]

Group 1: Company Overview - Cocrystal Pharma, Inc. is a clinical-stage biotechnology company focused on discovering and developing novel antiviral therapeutics targeting the replication processes of various viruses, including influenza, coronaviruses (such as SARS-CoV-2), noroviruses, and hepatitis C viruses [3] - The company utilizes unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs [3] Group 2: Event Information - Sam Lee, President and co-CEO of Cocrystal Pharma, will present a company overview at the Life Science Innovation Northwest (LSINW) 2025 Conference on April 23, 2025, at 3:00 p.m. Pacific time [1] - The LSINW conference is the largest annual life science event in the Pacific Northwest, featuring over 700 attendees and 80+ presentations from companies and research institutions [2] - The conference includes keynote addresses from industry leaders, panel discussions on emerging trends, and a startup fast pitch showdown, making it a significant event for the life science community in the region [2]

Financial Performance and Capital Needs - The company has an accumulated deficit of $333,418,000 from inception through December 31, 2024, and expects to continue incurring losses in the future [69]. - The company has never generated revenue from product sales and does not anticipate doing so for at least four years [68]. - The company has limited capital and substantial accumulated deficit, raising concerns about its ability to continue operations without obtaining additional financing [67]. - The company may need to raise additional capital or form strategic partnerships to support its research and development activities, which may not yield the desired results [74]. - The company may need to accept unfavorable terms in future financing efforts, which could restrict its ability to raise capital or pursue development opportunities [80]. - The company may need significant additional capital in the future to fund operations, which could lead to substantial dilution for existing stockholders [177]. - Future sales of large amounts of common stock or the perception of such sales could significantly decrease the stock price, even if the business performs well [182]. - The company may experience limitations on using net operating loss carryforwards due to potential ownership changes, which could increase future tax liabilities [183]. - The issuance of preferred stock could complicate third-party acquisitions and potentially depress the stock price [185]. - The company may face challenges in attracting new investors due to potential dilution from future capital raises [177]. Clinical Trials and Regulatory Challenges - The company is currently facing challenges in conducting clinical trials, including the need to extend enrollment for the oral CC-42344 Phase 2a study due to insufficient infection rates [73]. - The company is dependent on the successful completion of clinical trials and obtaining regulatory approvals to commercialize its product candidates [70]. - The company may face significant delays or failures in clinical trials due to adverse events or serious adverse events observed during testing [107]. - The commercial success of product candidates will depend on successful completion of clinical trials and obtaining marketing approvals [103]. - The company may need to conduct additional clinical trials if initial results are not positive, which could further delay commercialization [104]. - The ability to generate revenue is contingent upon obtaining regulatory approvals, which are expensive and time-consuming [99]. - Approximately 70% of drugs proceed past Phase 1 studies, 33% past Phase 2, and only 25%-30% reach Phase 4 in the FDA review process, highlighting the challenges in obtaining regulatory approval [98]. - The company has limited experience in conducting and managing preclinical development activities and clinical trials necessary for obtaining marketing approvals [120]. - The company has only entered a limited number of compounds into human clinical trials, including an influenza A product candidate in Phase 2a and a norovirus/coronaviruses product candidate in Phase 1 [120]. - The company has not obtained marketing approval or commercialized any of its product candidates, which may significantly harm its business if clinical trials are unsuccessful [121]. Competition and Market Dynamics - The company faces significant competition from major companies that have developed vaccines or treatments, which could adversely affect its market share and future prospects [78]. - The biotechnology and pharmaceutical industries are intensely competitive, with competitors having greater financial and technical resources, which could adversely affect the company's operating results [135]. - The company is focusing on programs in preclinical or early clinical development stages, facing competition from approved products and candidates in the market [136]. - Market acceptance of the company's product candidates will depend on factors such as clinical safety, efficacy, pricing, and reimbursement policies from third-party payors [148]. - The commercial success of the company's product candidates will depend on acceptance by the medical community, including physicians and healthcare payors [147]. Intellectual Property and Legal Risks - The company relies on a combination of patents, trade secret protection, and confidentiality agreements to protect its intellectual property, but there is uncertainty regarding the strength of these protections [122]. - The company may face significant challenges in obtaining or protecting necessary rights to drug compounds and processes for its development pipeline through acquisitions and in-licenses [114]. - The company may encounter significant problems in protecting and defending its intellectual property both in the United States and abroad, particularly in light of international agreements like the WTO waiver on patent protection for COVID-19 vaccines [125]. - The company’s commercial success depends on avoiding infringement on third-party patents, which poses a risk of litigation and could materially affect its business [126]. - The company may be required to file infringement claims or defend the validity of its patents, which can be expensive and time-consuming [130]. - The company may lack the capital to defend its intellectual property rights due to the costs involved in patent litigation [129]. - The company faces risks related to the disclosure of confidential information during intellectual property litigation, which could adversely affect its stock price [132]. - The company may need to obtain additional licenses for intellectual property rights from third parties, which could significantly harm its business if not acquired at reasonable costs or terms [133]. Operational and Management Challenges - The company relies on third-party partners for clinical trials and research, which has led to delays and increased costs due to staffing shortages and pandemic-related issues [82]. - The company relies on third-party manufacturers for preclinical and clinical supplies, which exposes it to risks such as supply chain shortages and manufacturing capacity issues [85]. - If third-party manufacturing issues arise, it could lead to increased costs or delays in obtaining regulatory approval and commercialization [89]. - The company expects to rely on limited sources for drug substances, which may cause delays in product development if supply is disrupted [87]. - Compliance with current Good Clinical Practices (cGCPs) is critical, as failure to do so may result in unreliable clinical data and additional trials being required [91]. - The company is highly dependent on key management and scientific personnel, and losing these individuals could materially impact its business [157]. - The company may face challenges in establishing sales and marketing capabilities, which are critical for generating product revenues [152]. - The company may experience increased operating expenses and reduced revenues due to foreign currency fluctuations and geopolitical actions [158]. - The company is vulnerable to business interruptions from natural disasters and pandemics, which could delay research and development efforts [165]. - The company may face cybersecurity threats that could disrupt operations and compromise confidential information, impacting its business [140]. - The company is exposed to risks from cybersecurity threats that could compromise sensitive information and disrupt operations [167]. - The adoption of artificial intelligence by competitors may put the company at a competitive disadvantage if it does not integrate similar technologies into its operations [143]. - The company anticipates significant capital expenditures for future growth, which may divert financial resources from other projects [159]. - The company faces potential product liability claims which could incur substantial costs and impact its financial performance [163]. - The company may face challenges in managing growth, potentially leading to operational mistakes and reduced productivity [159]. Stock and Market Considerations - As of March 28, 2025, approximately 10.2 million shares of common stock are outstanding, with about 6.8 million shares free trading or subject to Rule 144 sales limitations [179]. - Approximately 550,000 options and 256,000 RSUs are outstanding, which could result in the issuance of 806,000 shares of common stock if fully exercised [181]. - The absence of research coverage from major brokerage firms may hinder the development of an active market for the company's common stock [184]. - The company’s amended Bylaws establish exclusive forums for certain disputes, which may increase litigation costs and affect stockholder claims [187]. - The company operates in a volatile stock market environment, with potential impacts from geopolitical conflicts and economic uncertainty [176]. - The company is subject to various federal and state healthcare fraud and abuse laws, which could result in penalties and affect its operations [160]. - The company may incur substantial costs to comply with environmental, health, and safety laws, which could adversely affect its operations [170]. - The company is subject to additional restrictions on shares held by affiliates, limiting their ability to sell stock [181].