Cocrystal(COCP)

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Cocrystal Pharma Presents Phase 1 Results for Pan-Viral Inhibitor CDI-988 at Department of Defense Medical Conference
Globenewswire· 2025-08-05 12:00
Core Insights - Cocrystal Pharma, Inc. presented favorable safety and tolerability data for its oral pan-viral inhibitor CDI-988 at the 2025 Military Health System Research Symposium, supporting its clinical development for norovirus prophylaxis and treatment [1][4] Group 1: Study Results - The Phase 1 study included single-ascending (SAD) and multiple-ascending (MAD) cohorts, with all doses (100 mg to 1200 mg) well tolerated [2][5] - Treatment-emergent adverse events were 28% in CDI-988 subjects compared to 40% in placebo subjects for SAD cohorts, and 53% versus 92% for MAD cohorts, with headache being the most common adverse event [2][3] - No severe treatment-emergent adverse events or clinically significant pathology results were reported [2][3] Group 2: Clinical Development and Market Need - CDI-988's development is particularly relevant for military settings where norovirus poses operational risks due to its high transmissibility [3][4] - The absence of approved treatments or vaccines for norovirus creates a critical unmet medical need, with CDI-988 targeting viral replication across all norovirus genogroups [4][6] - Cocrystal plans to initiate a Phase 1b challenge study with CDI-988 in norovirus-infected healthy subjects later this year [4][7] Group 3: Company Overview and Technology - Cocrystal Pharma is a clinical-stage biotechnology company focused on developing novel antiviral therapeutics targeting various viruses, including noroviruses and coronaviruses [9] - CDI-988 was developed using Cocrystal's proprietary structure-based platform technology, designed as a broad-spectrum inhibitor targeting 3CL viral proteases [5][8] - Norovirus infections are estimated to cost society approximately $60 billion annually worldwide, highlighting the economic impact of this virus [6]
Cocrystal Pharma to Present Data from Phase 1 Study of First-in-Class Norovirus Protease Inhibitor CDI-988 at the 9th International Calicivirus Conference
Globenewswire· 2025-07-10 12:00
Core Viewpoint - Cocrystal Pharma, Inc. has announced that its pan-viral protease inhibitor CDI-988 will be presented at the International Calicivirus Conference, highlighting its potential as a treatment for norovirus infections, which currently lack approved antiviral therapies [1][2]. Group 1: Product Development - CDI-988 is a first-in-class oral treatment designed to inhibit noroviruses and coronaviruses, developed using Cocrystal's proprietary structure-based platform technology [3][6]. - The Phase 1 study of CDI-988 has been completed, focusing on safety, tolerability, and pharmacokinetics in healthy adults [3]. - The drug targets a highly conserved region in the active site of 3CL viral proteases, showcasing a novel mechanism of action and broad-spectrum antiviral activity [3][4]. Group 2: Market Context - Norovirus causes significant gastrointestinal illness with an estimated global societal cost of approximately $60 billion annually, according to the CDC [2]. - There are currently no approved vaccines or antiviral treatments for norovirus, indicating a substantial unmet medical need in this area [2]. Group 3: Conference Significance - The International Calicivirus Conference serves as a platform for leading experts in norovirus research, facilitating discussions and collaborations on advancements in the field [5]. - The conference will feature state-of-the-art lectures and presentations, providing an opportunity for Cocrystal to share its clinical development strategy and Phase 1 data for CDI-988 [2][5].
Cocrystal Pharma's Novel Norovirus Antiviral to be Presented at Department of Defense Medical Conference
GlobeNewswire News Room· 2025-06-05 12:00
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].
Cocrystal Pharma's Investigational Drug Candidate CC-42344 Demonstrates Strong Antiviral Potency Against the 2024 Highly Pathogenic H5N1 Avian Influenza Strain
GlobeNewswire News Room· 2025-05-29 12:00
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]
Cocrystal Pharma to Participate in Noble Capital Markets’ 2025 Emerging Growth Virtual Equity Conference
Globenewswire· 2025-05-28 12:00
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]
Cocrystal(COCP) - 2025 Q1 - Quarterly Results
2025-05-15 12:30
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]
Cocrystal(COCP) - 2025 Q1 - Quarterly Report
2025-05-15 12:30
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]
Cocrystal Pharma Reports First Quarter 2025 Financial Results and Provides Updates on its Antiviral Drug-Development Programs
GlobeNewswire News Room· 2025-05-15 12:00
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].
Cocrystal Pharma’s Norovirus Oral Antiviral Candidate Demonstrates Potent Activity Against the Emerging GII.17 Variants
Globenewswire· 2025-04-24 12:00
Core Insights - Cocrystal Pharma's investigational drug candidate CDI-988 demonstrates strong binding to the GII.17 protease, showing excellent potency against norovirus variants, particularly GII.4 and GII.17 strains [1][6] - The company plans to initiate a human norovirus challenge study in 2025 to evaluate CDI-988 for 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 enzymology and medicinal chemistry 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, targeting a highly conserved region in 3CL viral proteases [3] - A Phase 1 study has been completed, showing favorable safety and tolerability for CDI-988 in healthy adults [3][6] Technological Innovation - Cocrystal's proprietary structure-based platform technology provides near-atomic resolution insights into inhibitor complexes, facilitating rapid development of effective antiviral therapies [4] - The technology aims to identify novel binding sites and ensure a high barrier to viral resistance, enhancing the efficacy of antiviral treatments [4] Market Context - Norovirus is the leading cause of acute gastroenteritis globally, with an estimated 685 million cases and approximately 50,000 child deaths annually, resulting in a societal cost of around $60 billion [2] - The emergence of GII.17 variants has led to increased norovirus outbreaks, highlighting the urgent need for effective antiviral treatments [6]
Cocrystal Pharma's Norovirus Oral Antiviral Candidate Demonstrates Potent Activity Against the Emerging GII.17 Variants
Newsfilter· 2025-04-24 12:00
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]