RankAlpha logo
Back to Rankings

COCP

CocrystalF
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
Last Price
Quote time unavailable
View Chart
Documents
8
Stored
Transcripts
0
Recent loaded
Latest report
2026-05-15
Investor release

Document history

Earnings documents stored for COCP.

8 shown
Investor releaseQuarter not tagged2026-05-15

Cocrystal Pharma Provides Business Update and Reports First Quarter 2026 Financial Results

GlobeNewswire
Completed enrollment in first cohort of Phase 1b challenge study evaluating CDI-988 as a preventive and as a treatment for norovirus infection, began enrollment in prevention and treatment cohorts Highlighted CDI-988’s mechanism of action and clinical advancement at ICAR 2026 Granted FDA Fast Track designation for CDI-988, enabling the potential for an accelerated development pathway Received initial $225,000 of SBIR NIH grant for influenza A and B antiviral lead generation BOTHELL, Wash., May 15, 2026 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) provides updates on its antiviral product pipeline and business activities and reports financial results for the three months ended March 31, 2026. “Advancing CDI-988 into a Phase 1b human challenge study is a pivotal milestone for the Company and a meaningful step in our clinical strategy. The study’s innovative design allows us to efficiently evaluate CDI-988 as a preventive and as a treatment for norovirus infection,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal Pharma. “We were pleased to receive FDA Fast Track designation for CDI-988, which speaks to the significant unmet need in norovirus and provides a potential pathway to accelerate our work to address a widespread and underserved public health burden.” The ongoing Phase 1b randomized, double‑blind, placebo‑controlled challenge study (NCT07198139) is being conducted at Emory University School of Medicine in collaboration with the University of North Carolina. The study is designed to enroll up to 40 healthy adults, aged 18 to 49, in staged cohorts. The stage 1 infectivity cohort, now fully enrolled, will be followed by prevention and treatment cohorts in which CDI‑988 is administered at 1,200 mg twice daily for five days. The subjects in the prevention and treatment cohort have been enrolled. The primary efficacy endpoint is reduction in the incidence of clinical symptoms, with secondary endpoints including reduction in viral shedding, disease severity, safety and pharmacokinetics. “We recently received the initial payment under our SBIR Phase I award, bringing in non-dilutive funding to advance our influenza A and B program toward clinical development,” said James Martin, CFO and co-CEO of Cocrystal Pharma. “The successful completion of this first phase could position us to compete for a larger Phase II…Read full document

Completed enrollment in first cohort of Phase 1b challenge study evaluating CDI-988 as a preventive and as a treatment for norovirus infection, began enrollment in prevention and treatment cohorts Highlighted CDI-988’s mechanism of action and clinical advancement at ICAR 2026 Granted FDA Fast Track designation for CDI-988, enabling the potential for an accelerated development pathway Received initial $225,000 of SBIR NIH grant for influenza A and B antiviral lead generation BOTHELL, Wash., May 15, 2026 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) provides updates on its antiviral product pipeline and business activities and reports financial results for the three months ended March 31, 2026. “Advancing CDI-988 into a Phase 1b human challenge study is a pivotal milestone for the Company and a meaningful step in our clinical strategy. The study’s innovative design allows us to efficiently evaluate CDI-988 as a preventive and as a treatment for norovirus infection,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal Pharma. “We were pleased to receive FDA Fast Track designation for CDI-988, which speaks to the significant unmet need in norovirus and provides a potential pathway to accelerate our work to address a widespread and underserved public health burden.” The ongoing Phase 1b randomized, double‑blind, placebo‑controlled challenge study (NCT07198139) is being conducted at Emory University School of Medicine in collaboration with the University of North Carolina. The study is designed to enroll up to 40 healthy adults, aged 18 to 49, in staged cohorts. The stage 1 infectivity cohort, now fully enrolled, will be followed by prevention and treatment cohorts in which CDI‑988 is administered at 1,200 mg twice daily for five days. The subjects in the prevention and treatment cohort have been enrolled. The primary efficacy endpoint is reduction in the incidence of clinical symptoms, with secondary endpoints including reduction in viral shedding, disease severity, safety and pharmacokinetics. “We recently received the initial payment under our SBIR Phase I award, bringing in non-dilutive funding to advance our influenza A and B program toward clinical development,” said James Martin, CFO and co-CEO of Cocrystal Pharma. “The successful completion of this first phase could position us to compete for a larger Phase II award to support continued development. This award demonstrates our ongoing commitment to pursuing government and military funding to build and advance our antiviral pipeline.” Antiviral Product Pipeline Overview We leverage our proprietary structure-based drug discovery platform technology to develop next-generation, broad-spectrum antivirals that effectively block viral replication. Unlike other drug discovery approaches, our technology identifies compounds that bind to highly conserved regions of viral drug targets, including proteases and replication enzymes. By specifically targeting these essential viral functions, our drug candidates maintain efficacy as viruses mutate, while simultaneously minimizing off-target interactions that typically lead to adverse side effects. This dual advantage represents a significant breakthrough in antiviral drug development. In addition, our innovative methodology fundamentally transforms the conventional drug discovery paradigm by eliminating the inefficient, resource-intensive cycles of high-throughput compound screening and prolonged hit-to-lead optimization. The result is faster identification of promising candidates with superior resistance profiles and safety characteristics. Norovirus Program Norovirus is a common, highly contagious virus that afflicts people of all ages and causes symptoms of acute gastroenteritis including nausea, vomiting, stomach pain and diarrhea, as well as fatigue, fever and dehydration. There are currently no effective treatments or vaccines for norovirus, and the ability to curtail outbreaks is inadequate. With 685 million global cases annually and a $60 billion worldwide economic impact, norovirus represents one of healthcare's most pressing unmet needs. In the U.S., noroviruses are responsible for an estimated 21 million infections annually, including an estimated 109,000 hospitalizations, 465,000 emergency department visits and 900 deaths. The annual burden of norovirus to the U.S. is estimated at $10.6 billion. In the developing world, each year noroviruses are responsible for up to 1.1 million hospitalizations and 218,000 pediatric deaths. Oral protease inhibitor CDI-988 for the treatment of noroviruses and coronaviruses: Our first oral direct-acting antiviral CDI-988 targets the highly conserved region of the 3CL protease and is designed as a potential therapeutic for noroviruses and coronaviruses. CDI-988 has shown in vitro activity against multiple norovirus strains. In April 2025 we announced that CDI-988 showed superior broad-spectrum antiviral activity against the norovirus GII.17 strain, the most prevalent strain in the U.S. and Europe in 2024-2025. In August 2025 we presented favorable Phase 1 safety and tolerability data from all CDI-988 doses, including a high-dose 1,200 mg cohort, at the 2025 Military Health System Research Symposium (MHSRS). In September 2025 we discussed CDI-988’s scientific foundation and clinical progress in an oral presentation at the 9th International Calicivirus Conference, the leading calicivirus scientific meeting. In September 2025 we received a Study May Proceed Letter from the FDA to conduct a Phase 1b challenge study in the U.S. evaluating CDI-988 as a norovirus preventive and treatment. In March 2026 we enrolled the first subjects in our Phase 1b challenge study, which is being conducted at Emory University School of Medicine. In April 2026 we announced full enrollment in the first cohort of the Phase 1b study, which is evaluating the infectivity rate of the GII.2 challenge inoculum, at the International Conference on Antiviral Research 2026 (ICAR 2026). The subjects have been enrolled in the prevention and treatment cohort. Influenza Programs Influenza is a major global health threat that may become more challenging to treat due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Currently approved antiviral treatments for influenza are effective but are burdened with significant viral resistance. Each year approximately 1 billion cases of seasonal influenza, 3-5 million severe illnesses and up to 650,000 deaths are reported worldwide. About 8% of the U.S. population gets sick from flu each season. In addition to the health risk, influenza is responsible for an estimated $10.4 billion in direct medical costs in the U.S. each year. CC-42344 is our novel PB2 inhibitor that showed excellent in vitro activity against pandemic and seasonal influenza A strains, as well as against strains that are resistant to Tamiflu® and Xofluza®. Oral CC-42344 as a treatment for pandemic and seasonal influenza A In December 2022 we reported favorable Phase 1 safety and tolerability results. In December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, and viral and clinical measurements of CC-42344 in influenza A-infected subjects in the United Kingdom, following authorization from the UK Medicines and Healthcare Products Regulatory Agency. In May 2025 we reported that CC-42344 was shown to be active against the highly pathogenic 2024 Texas H5N1 avian influenza strain. In November 2025 an initial Phase 2a study was completed, with CC-42344 showing a favorable safety and tolerability profile with no serious adverse events and no drug-related discontinuations by study participants. Efficacy analyses were not reported due to issues with trial conduct. We plan to continue development of oral CC-42344 as a treatment for pandemic and seasonal influenza A with an additional Phase 2a study. Inhaled CC-42344 as prophylaxis and treatment for pandemic and seasonal influenza A Our preclinical testing showed superior pulmonary pharmacology with CC-42344, including high exposure to drug and a long half-life. We have developed a dry powder inhalation formulation of CC-42344 and have completed toxicology studies. Influenza A/B program In October 2025 we were awarded an approximate $500,000 Small Business Innovation Research (SBIR) Phase I grant from the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases to support the development of a novel, broad-spectrum lead candidate targeting the influenza A/B polymerase complex. In the first quarter of 2026 we received $225,000 under the SBIR award. SARS-CoV-2 and Other Coronavirus Program By targeting viral replication enzymes and proteases, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including SARS-CoV-2 and its variants, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome. CDI-988 showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses, as well as against noroviruses. By the end of 2031, the global COVID-19 therapeutics market is estimated to exceed $16 billion annually. Oral protease inhibitor CDI-988 for the treatment of coronaviruses and noroviruses: CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and demonstrated a favorable safety profile and pharmacokinetic properties. In August 2025 we presented favorable safety and tolerability Phase 1 data from all CDI-988 doses, including a high-dose 1,200 mg cohort, at the MHSRS. We are currently pursuing further development of CDI-988 as a preventive and treatment for norovirus infection and remain optimistic about its viability as a treatment for coronaviruses. First Quarter Financial Results Revenue for the first quarter of 2026 was $225,000, representing payments from an NIH SBIR award for an influenza A/B Inhibitor program. The Company reported no revenue for the first quarter of 2025. Research and development expenses for the first quarters of 2026 and 2025 were $1.4 million. General and administrative expenses for the first quarter of 2026 were $1.2 million compared with $1.0 million for the first quarter of 2025, with the increase primarily due to an increase in legal and consultant costs, partially offset by a decrease in salaries and wages. Net loss for the first quarter of 2026 was $2.3 million, or $0.17 per share on 13.8 million common shares outstanding, compared with a net loss for the first quarter of 2025 of $2.3 million, or $0.23 per share on 10.2 common shares outstanding. Cocrystal reported unrestricted cash as of March 31, 2026, of $4.7 million compared with $7.7 million as of December 31, 2025. Net cash used in operating activities was $2.3 million for the three months ended March 31, 2026, compared with $2.9 million for the same period in 2025. The Company had working capital of $3.7 million as of March 31, 2026. About Cocrystal Pharma, Inc. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2) and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create viable antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the ongoing Phase 1b norovirus trial, our future potential for government grants, and the further development of our oral CC-42344 product candidate. The words "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "could," "target," "potential," "is likely," "will," "expect" and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from inflation, affordability, a deteriorating labor market, the possibility of a recession, increases or other developments with respect to interest rates, uncertainty surrounding the impacts arising from imposed and threatened tariffs and developments with respect thereto, and wars and geopolitical conflicts including those in Ukraine and with Iran on our Company, our collaboration partners, and on the U.S. and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors and our current and any future CROs and CMOs, the progress and results of the studies for CDI-988 and CC-42344 including issues with the initial Phase 2a study for CC-42344 which will prolong the development timeline of such product candidate, the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes and potential litigation challenging initiatives and actions taken by the Trump Administration which could, among other things, result in delays in regulatory approvals or limit access to federal funding for our programs, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop, and our liquidity. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Investor Contact: Alliance Advisors IR Bruce Voss [email protected] 310-691-7104 Financial Tables to follow COCRYSTAL PHARMA, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except per share data) COCRYSTAL PHARMA, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except per share data) # # #

Investor releaseQuarter not tagged2026-03-31

Cocrystal Pharma Reports 2025 Financial Results and Provides Updates on its Antiviral Drug-Development Programs

GlobeNewswire
Phase 1b norovirus challenge study is underway at Emory University School of Medicine CDI-988 is the first oral antiviral candidate being developed for norovirus treatment and prevention No approved treatments or vaccines are available for norovirus infection, posing a significant unmet need and contributing to a global economic burden of $60 billion annually BOTHELL, Wash., March 31, 2026 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the year ended December 31, 2025, and provides updates on its antiviral product pipeline, upcoming milestones and business activities. “We are delighted to report that our norovirus human challenge study evaluating efficacy and safety of CDI‑988 is underway at Emory University School of Medicine. In our first cohort, healthy subjects are being inoculated with the GII.2 (Snow Mountain Virus) strain under highly controlled conditions,” said Sam Lee, Ph.D., President and co‑CEO of Cocrystal. “Norovirus remains a significant and underserved market. Developing an effective norovirus antiviral or vaccine has been challenging due to the high genetic and antigenic diversity of norovirus and lack of simple in vitro cell-based assays and animal model system,” Dr. Lee continued. “Using our proprietary structure‑based drug discovery platform technology, we developed CDI‑988 as a direct‑acting, oral antiviral that targets a highly conserved region of the viral 3CL protease found in all known norovirus strains. As a pan-viral 3CL protease inhibitor, CDI‑988 also holds potential as a broad‑spectrum antiviral effective against coronaviruses.” “Norovirus outbreaks can strike at any time of year in semi-closed environments such as cruise ships, military settings, and healthcare and assisted-living facilities,” said James Martin, Cocrystal's CFO and co-CEO. “This constant threat underscores the need for an effective oral treatment and preventive that can be deployed whenever and wherever norovirus infections emerge. With CDI-988, our goal is to provide an easy-to-administer, safe and effective drug to combat these unpredictable outbreaks. We believe CDI‑988 represents a key value-creating opportunity for our Company and our investors.” The Phase 1b randomized, double-blind, placebo-controlled study will enroll up to 40 subjects. The study’s primary endpoint is efficacy in re…Read full document

Phase 1b norovirus challenge study is underway at Emory University School of Medicine CDI-988 is the first oral antiviral candidate being developed for norovirus treatment and prevention No approved treatments or vaccines are available for norovirus infection, posing a significant unmet need and contributing to a global economic burden of $60 billion annually BOTHELL, Wash., March 31, 2026 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the year ended December 31, 2025, and provides updates on its antiviral product pipeline, upcoming milestones and business activities. “We are delighted to report that our norovirus human challenge study evaluating efficacy and safety of CDI‑988 is underway at Emory University School of Medicine. In our first cohort, healthy subjects are being inoculated with the GII.2 (Snow Mountain Virus) strain under highly controlled conditions,” said Sam Lee, Ph.D., President and co‑CEO of Cocrystal. “Norovirus remains a significant and underserved market. Developing an effective norovirus antiviral or vaccine has been challenging due to the high genetic and antigenic diversity of norovirus and lack of simple in vitro cell-based assays and animal model system,” Dr. Lee continued. “Using our proprietary structure‑based drug discovery platform technology, we developed CDI‑988 as a direct‑acting, oral antiviral that targets a highly conserved region of the viral 3CL protease found in all known norovirus strains. As a pan-viral 3CL protease inhibitor, CDI‑988 also holds potential as a broad‑spectrum antiviral effective against coronaviruses.” “Norovirus outbreaks can strike at any time of year in semi-closed environments such as cruise ships, military settings, and healthcare and assisted-living facilities,” said James Martin, Cocrystal's CFO and co-CEO. “This constant threat underscores the need for an effective oral treatment and preventive that can be deployed whenever and wherever norovirus infections emerge. With CDI-988, our goal is to provide an easy-to-administer, safe and effective drug to combat these unpredictable outbreaks. We believe CDI‑988 represents a key value-creating opportunity for our Company and our investors.” The Phase 1b randomized, double-blind, placebo-controlled study will enroll up to 40 subjects. The study’s primary endpoint is efficacy in reducing the incidence of clinical symptoms; secondary endpoints include reduction of viral shedding and disease severity, and safety and pharmacokinetic profiles. Antiviral Product Pipeline Overview We leverage our innovative structure-based drug discovery platform technology to develop next-generation, broad-spectrum antivirals that effectively block viral replication. Unlike other drug discovery approaches, our technology identifies compounds that bind to highly conserved regions of viral drug targets, including proteases and replication enzymes. By specifically targeting these essential viral functions, our drug candidates maintain efficacy even as viruses mutate, while simultaneously minimizing off-target interactions that typically lead to adverse side effects. This dual advantage represents a significant breakthrough in antiviral drug development. In addition, our innovative methodology fundamentally transforms the conventional drug discovery paradigm by eliminating the inefficient, resource-intensive cycles of high-throughput compound screening and prolonged hit-to-lead optimization. The result is faster identification of promising candidates with superior resistance profiles and safety characteristics. Norovirus Program Norovirus is a common, highly contagious virus that afflicts people of all ages and causes symptoms of acute gastroenteritis including nausea, vomiting, stomach pain and diarrhea, as well as fatigue, fever and dehydration. There are currently no effective treatments or vaccines for norovirus, and the ability to curtail outbreaks is inadequate. With 685 million global cases annually and a $60 billion worldwide economic impact, norovirus represents one of healthcare's most pressing unmet needs. In the U.S., noroviruses are responsible for an estimated 21 million infections annually, including an estimated 109,000 hospitalizations, 465,000 emergency department visits and 900 deaths. The annual burden of norovirus to the U.S. is estimated at $10.6 billion. In the developing world, each year noroviruses are responsible for up to 1.1 million hospitalizations and 218,000 pediatric deaths. Oral protease inhibitor CDI-988 for the treatment of noroviruses and coronaviruses: Our novel, broad-spectrum 3CL protease inhibitor CDI-988 is designed as a potential treatment for noroviruses and coronaviruses. CDI-988 has shown in vitro activity against multiple norovirus strains. In April 2025 we announced that CDI-988 showed superior broad-spectrum antiviral activity against the norovirus GII.17 strain, the most prevalent strain in the U.S. and Europe in 2024-2025. In August 2025 we presented favorable Phase 1 safety and tolerability data from all CDI-988 doses, including a high-dose 1200 mg cohort, at the 2025 Military Health System Research Symposium (MHSRS). In September 2025 we discussed CDI-988’s scientific foundation and clinical progress in an oral presentation at the 9th International Calicivirus Conference, the leading calicivirus scientific meeting. In September 2025 we received a Study May Proceed Letter from the FDA to conduct a Phase 1b challenge study in the U.S. evaluating CDI-988 as a norovirus preventive and treatment. In March 2026 we enrolled the first subjects in our Phase 1b challenge study with the initial cohort evaluating the infectivity rate of the GII.2 challenge inoculum, and subsequent cohorts to be orally administered CDI-988 or placebo. Influenza Programs Influenza is a major global health threat that may become more challenging to treat due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Currently approved antiviral treatments for influenza are effective but are burdened with significant viral resistance. Each year approximately 1 billion cases of seasonal influenza, 3-5 million severe illnesses and up to 650,000 deaths are reported worldwide. About 8% of the U.S. population gets sick from flu each season. In addition to the health risk, influenza is responsible for an estimated $10.4 billion in direct medical costs in the U.S. each year. CC-42344 is our novel PB2 inhibitor that showed excellent in vitro activity against pandemic and seasonal influenza A strains, as well as against strains that are resistant to Tamiflu® and Xofluza®. Oral CC-42344 as a treatment for pandemic and seasonal influenza A In December 2022 we reported favorable Phase 1 safety and tolerability results. In December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, and viral and clinical measurements of CC-42344 in influenza A-infected subjects in the United Kingdom, following authorization from the UK Medicines and Healthcare Products Regulatory Agency. In May 2025 we reported that CC-42344 was shown to be active against the highly pathogenic 2024 Texas H5N1 avian influenza strain. In November 2025 an initial Phase 2a study was completed, with CC-42344 showing a favorable safety and tolerability profile with no serious adverse events and no drug-related discontinuations by study participants. Efficacy analyses were not reported due to issues with trial conduct. We plan to continue development of oral CC-42344 as a treatment for pandemic and seasonal influenza A with an additional Phase 2a study. Inhaled CC-42344 as prophylaxis and treatment for pandemic and seasonal influenza A Our preclinical testing showed superior pulmonary pharmacology with CC-42344, including high exposure to drug and a long half-life. We have developed a dry powder inhalation formulation and have completed toxicology studies. Influenza A/B program In October 2025 we received a $500,000 Small Business Innovation Research Phase I award from the NIH’s National Institute of Allergy and Infectious Diseases to support the development of a novel, broad-spectrum lead candidate targeting the influenza A/B polymerase complex. SARS-CoV-2 and Other Coronavirus Program By targeting viral replication enzymes and proteases, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including SARS-CoV-2 and its variants, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome. CDI-988 showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses, as well as against noroviruses. By the end of 2031, the global COVID-19 therapeutics market is estimated to exceed $16 billion annually. Oral protease inhibitor CDI-988 for the treatment of coronaviruses and noroviruses: CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and demonstrated a favorable safety profile and pharmacokinetic properties. In August 2025 we presented favorable safety and tolerability Phase 1 data from all CDI-988 doses, including a high-dose 1200 mg cohort, at the MHSRS. We are currently pursuing further development of CDI-988 as a prophylaxis and treatment for norovirus and remain optimistic about its viability as a treatment for coronaviruses. 2025 Financial Results Research and development expenses for 2025 were $5.1 million compared with $12.5 million for 2024, with the decrease primarily due to lower costs with the winddown of the Phase 2a influenza study and reduction in employee-related expenses. General and administrative expenses for 2025 were $4.0 million compared with $5.3 million for 2024, with the decrease primarily due to a reduction in compensation, insurance and corporate expenses. Net loss for 2025 was $8.8 million, or $0.78 per share, compared with a net loss for 2024 of $17.5 million, or $1.72 per share. Cocrystal reported unrestricted cash as of December 31, 2025, of $7.7 million compared with $9.9 million as of December 31, 2024. Net cash used in operating activities for 2025 was $8.2 million compared with $16.5 million for 2024. The Company had working capital of $5.9 million and 11.3 million common shares outstanding as of December 31, 2025. About Cocrystal Pharma, Inc. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2) and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create viable antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans for the future development of preclinical and clinical product candidates, the and the potential characteristics and benefits of and market for our product candidates. The words "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "could," "target," "potential," "is likely," "will," "expect" and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from inflation, affordability, a deteriorating labor market, the possibility of recession, increases or other developments with respect to interest rates, uncertainty surrounding the impacts arising from imposed and threatened tariffs and developments with respect thereto, and wars and geopolitical conflicts including those in the Middle East and Ukraine on our Company, our collaboration partners, and on the U.S. and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors and our current and any future CROs and CMOs, the progress and results of the studies for CC-42344 and CDI-988 including issues with the initial Phase 2a study for CC-42344 which will prolong the development timeline of such product candidate, the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes including based on initiatives and actions taken by the Trump Administration which could, among other things, result in delays in regulatory approvals or limit access to federal funding for our programs, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, and potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Investor Contact: Alliance Advisors IR Jody Cain 310-691-7100 [email protected] Financial Tables to follow COCRYSTAL PHARMA, INC. CONSOLIDATED BALANCE SHEETS (Dollars and shares in thousands, except per share data) COCRYSTAL PHARMA, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (Dollars and shares in thousands, except per share data) # # #

Investor releaseQuarter not tagged2025-11-14

Cocrystal Pharma Reports Third Quarter 2025 Financial Results and Provides Updates on its Antiviral Drug-Development Programs

GlobeNewswire
Received FDA IND clearance to evaluate CDI-988 as both norovirus preventive and treatment Expects to initiate CDI-988 Phase 1b norovirus challenge study in Q1 2026 Granted NIH SBIR award to advance influenza A/B replication inhibitor program BOTHELL, Wash., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the three and nine months ended September 30, 2025, and provides updates on its antiviral product pipeline, upcoming milestones and business activities. “We expect to begin enrolling participants in the first quarter of 2026 for our norovirus challenge study evaluating CDI-988, our oral broad-spectrum protease inhibitor,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “This study will provide an initial assessment of CDI-988 for both prevention and treatment of norovirus infection. Norovirus is a major cause of acute gastroenteritis and is highly contagious. It spreads rapidly in enclosed environments such as cruise ships, military bases, nursing homes, and hospitals. At present, there is no FDA-approved treatment or prevention for norovirus infection. “We were honored to receive a Small Business Innovation (SBIR) award from the National Institutes of Health (NIH) to advance our work in developing a novel, broad-spectrum lead candidate targeting the influenza A/B polymerase complex,” added Dr. Lee. “This recognition further validates the strength of our structure-based drug discovery platform technology and its capability to develop innovative antiviral therapies for addressing unmet medical needs.” “Together with the non-dilutive SBIR award, we strengthened our balance sheet through two recent at-the-market financings under Nasdaq rules,” said James Martin, Cocrystal's CFO and co-CEO. “This enhanced cash position supports the continued development of our product pipeline, including our potentially groundbreaking norovirus program.” In September 2025 Cocrystal raised gross proceeds of $4.7 million from a registered direct offering along with a private placement of warrants that, if fully exercised on a cash basis, will raise an additional $8.3 million. In October 2025, the Company completed a private placement with directors and management for gross proceeds of $1.03 million with warrants that, if fully exercised on a cash basis, will raise an additional $1.83 milli…Read full document

Received FDA IND clearance to evaluate CDI-988 as both norovirus preventive and treatment Expects to initiate CDI-988 Phase 1b norovirus challenge study in Q1 2026 Granted NIH SBIR award to advance influenza A/B replication inhibitor program BOTHELL, Wash., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the three and nine months ended September 30, 2025, and provides updates on its antiviral product pipeline, upcoming milestones and business activities. “We expect to begin enrolling participants in the first quarter of 2026 for our norovirus challenge study evaluating CDI-988, our oral broad-spectrum protease inhibitor,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “This study will provide an initial assessment of CDI-988 for both prevention and treatment of norovirus infection. Norovirus is a major cause of acute gastroenteritis and is highly contagious. It spreads rapidly in enclosed environments such as cruise ships, military bases, nursing homes, and hospitals. At present, there is no FDA-approved treatment or prevention for norovirus infection. “We were honored to receive a Small Business Innovation (SBIR) award from the National Institutes of Health (NIH) to advance our work in developing a novel, broad-spectrum lead candidate targeting the influenza A/B polymerase complex,” added Dr. Lee. “This recognition further validates the strength of our structure-based drug discovery platform technology and its capability to develop innovative antiviral therapies for addressing unmet medical needs.” “Together with the non-dilutive SBIR award, we strengthened our balance sheet through two recent at-the-market financings under Nasdaq rules,” said James Martin, Cocrystal's CFO and co-CEO. “This enhanced cash position supports the continued development of our product pipeline, including our potentially groundbreaking norovirus program.” In September 2025 Cocrystal raised gross proceeds of $4.7 million from a registered direct offering along with a private placement of warrants that, if fully exercised on a cash basis, will raise an additional $8.3 million. In October 2025, the Company completed a private placement with directors and management for gross proceeds of $1.03 million with warrants that, if fully exercised on a cash basis, will raise an additional $1.83 million. Antiviral Product Pipeline Overview We harness our revolutionary, structure-based drug discovery platform technology to engineer next-generation, broad-spectrum antivirals that precisely disrupt viral replication mechanisms. Unlike traditional approaches, our technology identifies compounds that bind to highly conserved regions of viral enzymes, thereby creating a formidable defense against current viral threats as well as their mutations. By specifically targeting these evolutionary-constrained viral regions, our drug candidates maintain efficacy even as viruses mutate, while simultaneously minimizing off-target interactions that typically lead to adverse side effects. This dual advantage represents a significant breakthrough in antiviral drug development. In addition, our innovative methodology fundamentally transforms the conventional drug discovery paradigm by eliminating the inefficient, resource-intensive cycles of high-throughput compound screening and prolonged hit-to-lead optimization. The result is faster identification of promising candidates with superior resistance profiles and safety characteristics. Norovirus Program Norovirus is a common and highly contagious virus that afflicts people of all ages and causes symptoms of acute gastroenteritis including nausea, vomiting, stomach pain and diarrhea, as well as fatigue, fever and dehydration. There is currently no effective treatment or effective vaccine for norovirus, and the ability to curtail outbreaks is limited. With 685 million global cases annually and a $60 billion worldwide economic impact, norovirus represents one of healthcare's most pressing unmet needs. In the U.S., noroviruses are responsible for an estimated 21 million infections annually, including 109,000 hospitalizations, 465,000 emergency department visits and an estimated 900 deaths. The annual burden of norovirus to the U.S. is estimated at $10.6 billion. Noroviruses are responsible for up to 1.1 million hospitalizations and 218,000 deaths annually in children in the developing world. Oral protease inhibitor CDI-988 for the treatment of noroviruses and coronaviruses Our novel, broad-spectrum protease inhibitor CDI-988 is being evaluated as a potential treatment for noroviruses and coronaviruses. CDI-988 has shown in vitro activity against multiple norovirus strains. In May 2023 we announced approval of our application to the Australian regulatory agency for a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability and pharmacokinetics (PK) of CDI-988 in healthy subjects. In August 2023 we announced our selection of CDI-988 as our lead compound for the treatment for noroviruses, in addition to coronaviruses. In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study. In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a high-dose cohort. In April 2025 we announced that CDI-988 showed superior broad-spectrum antiviral activity against GII.17 strains, the most prevalent strain in the U.S. and Europe in 2024-2025. In August 2025 we presented favorable safety and tolerability Phase 1 data from all CDI-988 doses, including the high-dose 1200 mg cohort, at the 2025 Military Health System Research Symposium (MHSRS). In September 2025 we received a Study May Proceed Letter from the FDA to conduct a Phase 1b challenge study in the U.S. evaluating CDI-988 as a norovirus preventive and treatment. Preparations are underway for the challenge study, with subject enrollment expected to begin in the first quarter of 2026. Influenza Programs Influenza is a major global health threat that may become more challenging to treat due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Currently approved antiviral treatments for influenza are effective but are burdened with significant viral resistance. Each year approximately 1 billion cases of seasonal influenza, 3-5 million severe illnesses and up to 650,000 deaths are reported worldwide. About 8 percent of the U.S. population gets sick from flu each season. In addition to the health risk, influenza is responsible for an estimated $10.4 billion in direct medical costs in the U.S. each year. Oral CC-42344 for the treatment of pandemic and seasonal influenza A Our novel PB2 inhibitor CC-42344 showed excellent in vitro activity against pandemic and seasonal influenza A strains, as well as strains that are resistant to Tamiflu® and Xofluza®. In December 2022 we reported favorable safety and tolerability results from the CC-42344 Phase 1 study. In December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, viral and clinical measurements of CC-42344 in influenza A-infected subjects in the United Kingdom, following authorization from the UK Medicines and Healthcare Products Regulatory Agency (MHRA). In May 2024 we completed enrollment in the Phase 2a human challenge study. In June 2024 we reported that in vitro studies demonstrated CC-42344 inhibits the activity of the highly pathogenic avian influenza A (H5N1) PB2 protein identified in humans exposed to infected dairy cows. In December 2024 we announced a plan to extend the CC-42344 Phase 2a human challenge study due to unexpectedly low influenza infection among study participants. In May 2025 we reported that CC-42344 was shown to be active against the highly pathogenic 2024 Texas H5N1 avian influenza strain. In November 2025 our Phase 2a study was completed, with CC-42344 showing a favorable safety and tolerability profile with no serious adverse events (SAEs) and no drug-related discontinuations by study participants. Efficacy analyses were not reported due to issues in trial conduct. We plan to continue development of oral CC-42344 as a treatment for pandemic and seasonal influenza A. Inhaled CC-42344 as prophylaxis and treatment for pandemic and seasonal influenza A Our preclinical testing showed superior pulmonary pharmacology with CC-42344, including high exposure to drug and a long half-life. We have developed a dry powder inhalation formulation and have completed toxicology studies. Influenza A/B program In October 2025 we received a $500,000 SBIR Phase I award from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) to support the development of a novel, broad-spectrum lead candidate targeting the influenza A/B polymerase complex. SARS-CoV-2 and Other Coronavirus Program By targeting viral replication enzymes and proteases, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including SARS-CoV-2 and its variants, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). CDI-988 showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses, as well as against noroviruses. The global COVID-19 therapeutics market is estimated to exceed $16 billion annually by the end of 2031. Oral protease inhibitor CDI-988 for the treatment of coronaviruses and noroviruses CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and demonstrated a favorable safety profile and PK properties. In September 2023 we dosed the first healthy subject in our norovirus/coronavirus CDI-988 study, which is expected to serve as a Phase 1 study for both indications. In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study. In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a high-dose cohort. In August 2025 we presented favorable safety and tolerability Phase 1 data from all CDI-988 doses, including the high-dose 1200 mg cohort, at the MHSRS. Third Quarter Financial Results Research and development (R&D) expenses for the third quarter of 2025 were $954,000, compared with $3.2 million for the third quarter of 2024, with the decrease primarily due to the timing of clinical study costs as the trials started in 2024 were winding down in 2025. General and administrative (G&A) expenses for the third quarter of 2025 were $1.1 million, compared with $1.8 million for the third quarter of 2024, with the decrease primarily due to a reduction in compensation expense. Net loss for the third quarter of 2025 was $2.0 million, or $0.19 per share, compared with a net loss for the third quarter of 2024 of $4.9 million, or $0.49 per share. Nine Months Financial Results R&D expenses for the first nine months of 2025 were $3.4 million, compared with $10.5 million for the first nine months of 2024. G&A expenses for the first nine months of 2025 were $3.1 million, compared with $4.1 million for the first nine months of 2024. Net loss for the first nine months of 2025 was $6.4 million, or $0.61 per share, compared with a net loss for the first nine months of 2024 of $14.2 million, or $1.40 per share. Cocrystal reported unrestricted cash as of September 30, 2025 of $7.7 million, which included $4.7 million in gross proceeds from a registered direct financing completed in September 2025, compared with $9.9 million as of December 31, 2024. Net cash used in operating activities for the first nine months of 2025 was $6.5 million, compared with $13.3 million for the first nine months of 2024. The Company had working capital of $7.3 million and 13.0 million common shares outstanding as of September 30, 2025. In October 2025 Cocrystal was granted an NIH SBIR award for $500,000 and completed a private placement for $1.03 million in gross proceeds. About Cocrystal Pharma, Inc. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create viable antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans for the future development of preclinical and clinical product candidates including the potential of our norovirus product candidates, our plans to initiate a human Phase 1b challenge study for our norovirus product candidate CDI-988 in early 2026, and our plans with regard to continued development of CC-42344, the potential characteristics and benefits of and market for our product candidates, and potential future capital we may receive from warrant exercises for cash. The words "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "could," "target," "potential," "is likely," "will," "expect" and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from our need for additional capital to fund our operations and our ability to obtain such capital on favorable terms or at all, inflation, the possibility of a recession, interest rate increases, imposed and threated tariffs, and geopolitical conflicts including those in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., UK, Australia and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials for and otherwise proceed with studies as well as similar problems with our vendors and our current and any future clinical research organization (CROs) and contract manufacturing organizations (CMOs), the progress and results of the studies including any adverse findings or delays, the ability of us and our CROs to recruit volunteers for, and to otherwise proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes and any adverse developments which may arise therefrom, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the potential for the development of effective treatments by competitors which could reduce or eliminate a prospective future market share commercializing any product candidates we may develop in the future, and our ability to meet our future liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Investor Contact: Alliance Advisors IR Jody Cain 310-691-7100 [email protected] COCRYSTAL PHARMA, INC. CONSOLIDATED BALANCE SHEETS (in thousands) COCRYSTAL PHARMA, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except per share data) # # #

Investor releaseQuarter not tagged2025-08-14

Cocrystal Pharma Reports Second Quarter 2025 Financial Results and Provides Updates on its Antiviral Drug-Development Programs

GlobeNewswire
Favorable CDI-988 Phase 1 safety and tolerability reported Challenge study with CDI-988 as a norovirus preventive and treatment planned later this year BOTHELL, Wash., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the three and six months ended June 30, 2025, and provides updates on its antiviral product pipeline, upcoming milestones and business activities. “Preparations are underway for a Phase 1b norovirus challenge study to evaluate our potent, oral antiviral candidate CDI-988 as a prophylaxis and treatment,” said Sam Lee, Ph.D., Cocrystal's President and co-CEO. “We are encouraged by the favorable safety and tolerability results from our Phase 1 study with CDI-988. This novel protease inhibitor has the potential to transform how we manage this highly contagious virus, which spreads rapidly in military facilities, cruise ships, nursing homes, hospitals and other confined environments. As a prophylactic treatment, CDI-988 could potentially prevent rapid spread of norovirus outbreaks in close quarters. “We developed CDI-988 for the treatment of norovirus and coronavirus infections using our proprietary structure-based drug discovery platform technology. We are encouraged by our recent in vitro data demonstrating CDI-988 inhibits newly re-emerging norovirus GII.17 strains that are responsible for the 2024-2025 norovirus outbreaks,” added Dr. Lee. “The absence of any approved norovirus treatments or vaccines creates a substantial market opportunity for Cocrystal,” said James Martin, Cocrystal's CFO and co-CEO. “With 685 million global cases annually and a $60 billion worldwide economic impact, norovirus represents one of healthcare's most pressing unmet needs.” Antiviral Product Pipeline Overview We harness our revolutionary, structure-based drug discovery platform technology to engineer next-generation, broad-spectrum antivirals that precisely disrupt viral replication mechanisms. Unlike traditional approaches, our technology identifies compounds that bind to highly conserved regions of viral enzymes, thereby creating a formidable defense against current viral threats as well as their mutations. By specifically targeting these evolutionary-constrained viral regions, our drug candidates maintain efficacy even as viruses mutate, while simultaneously minimizing off-target in…Read full document

Favorable CDI-988 Phase 1 safety and tolerability reported Challenge study with CDI-988 as a norovirus preventive and treatment planned later this year BOTHELL, Wash., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the three and six months ended June 30, 2025, and provides updates on its antiviral product pipeline, upcoming milestones and business activities. “Preparations are underway for a Phase 1b norovirus challenge study to evaluate our potent, oral antiviral candidate CDI-988 as a prophylaxis and treatment,” said Sam Lee, Ph.D., Cocrystal's President and co-CEO. “We are encouraged by the favorable safety and tolerability results from our Phase 1 study with CDI-988. This novel protease inhibitor has the potential to transform how we manage this highly contagious virus, which spreads rapidly in military facilities, cruise ships, nursing homes, hospitals and other confined environments. As a prophylactic treatment, CDI-988 could potentially prevent rapid spread of norovirus outbreaks in close quarters. “We developed CDI-988 for the treatment of norovirus and coronavirus infections using our proprietary structure-based drug discovery platform technology. We are encouraged by our recent in vitro data demonstrating CDI-988 inhibits newly re-emerging norovirus GII.17 strains that are responsible for the 2024-2025 norovirus outbreaks,” added Dr. Lee. “The absence of any approved norovirus treatments or vaccines creates a substantial market opportunity for Cocrystal,” said James Martin, Cocrystal's CFO and co-CEO. “With 685 million global cases annually and a $60 billion worldwide economic impact, norovirus represents one of healthcare's most pressing unmet needs.” Antiviral Product Pipeline Overview We harness our revolutionary, structure-based drug discovery platform technology to engineer next-generation, broad-spectrum antivirals that precisely disrupt viral replication mechanisms. Unlike traditional approaches, our technology identifies compounds that bind to highly conserved regions of viral enzymes, thereby creating a formidable defense against current viral threats as well as their mutations. By specifically targeting these evolutionary-constrained viral regions, our drug candidates maintain efficacy even as viruses mutate, while simultaneously minimizing off-target interactions that typically lead to adverse side effects. This dual advantage represents a significant breakthrough in antiviral drug development. In addition, our innovative methodology fundamentally transforms the conventional drug discovery paradigm by eliminating the inefficient, resource-intensive cycles of high-throughput compound screening and prolonged hit-to-lead optimization. The result is faster identification of promising candidates with superior resistance profiles and safety characteristics. Influenza Programs Influenza is a major global health threat that may become more challenging to treat due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Currently approved antiviral treatments for influenza are effective but are burdened with significant viral resistance. Each year there are approximately 1 billion cases of seasonal influenza worldwide, 3-5 million severe illnesses and up to 650,000 deaths. About 8 percent of the U.S. population gets sick from flu each season. In addition to the health risk, influenza is responsible for an estimated $10.4 billion in direct medical costs in the U.S. each year. Oral CC-42344 for the treatment of pandemic and seasonal influenza A Our novel PB2 inhibitor CC-42344 showed excellent in vitro activity against pandemic and seasonal influenza A strains, as well as strains that are resistant to Tamiflu® and Xofluza®. In December 2022 we reported favorable safety and tolerability results from the CC-42344 Phase 1 study. In December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, viral and clinical measurements of CC-42344 in influenza A-infected subjects in the United Kingdom, following authorization from the UK Medicines and Healthcare Products Regulatory Agency (MHRA). In May 2024 we completed enrollment in the Phase 2a human challenge study. In June 2024 we reported that in vitro studies demonstrated CC-42344 inhibits the activity of the highly pathogenic avian influenza A (H5N1) PB2 protein identified in humans exposed to infected dairy cows. In December 2024 we announced a plan to extend the CC-42344 Phase 2a human challenge study due to unexpectedly low influenza infection among study participants. In May 2025 we reported that CC-42344 was shown to be active against the highly pathogenic 2024 Texas H5N1 avian influenza strain. Inhaled CC-42344 as prophylaxis and treatment for pandemic and seasonal influenza A Our preclinical testing showed superior pulmonary pharmacology with CC-42344, including high exposure to drug and a long half-life. Dry powder inhalation formulation development and toxicology studies have been completed. Influenza A/B program Our efforts to develop a preclinical lead of novel influenza replication inhibitors for pandemic and season influenza are ongoing. Norovirus Program Norovirus is a common and highly contagious virus that afflicts people of all ages and causes symptoms of acute gastroenteritis including nausea, vomiting, stomach pain and diarrhea, as well as fatigue, fever and dehydration. There is currently no effective treatment or effective vaccine for norovirus, and the ability to curtail outbreaks is limited. In the U.S., noroviruses are responsible for an estimated 21 million infections annually, including 109,000 hospitalizations, 465,000 emergency department visits and an estimated 900 deaths. The annual burden of norovirus to the U.S. is estimated at $10.6 billion. Noroviruses are responsible for up to 1.1 million hospitalizations and 218,000 deaths annually in children in the developing world. Oral pan-viral protease inhibitor CDI-988 for the treatment of noroviruses and coronaviruses Our novel, broad-spectrum protease inhibitor CDI-988 is being evaluated as a potential treatment for noroviruses and coronaviruses. CDI-988 has shown in vitro pan-viral activity against multiple norovirus strains. In May 2023 we announced approval of our application to the Australian regulatory agency for a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability and pharmacokinetics (PK) of CDI-988 in healthy subjects. In August 2023 we announced our selection of CDI-988 as our lead compound for the treatment for noroviruses, in addition to coronaviruses. In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study. In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a high-dose cohort. In April 2025 we announced that CDI-988 showed superior broad-spectrum antiviral activity against GII.17 strains, the most prevalent strain in the U.S. and Europe in 2024-2025. In August 2025 we presented favorable safety and tolerability Phase 1 data from all CDI-988 doses, including the high-dose 1200 mg cohort, at the 2025 Military Health System Research Symposium (MHSRS). We plan to initiate a human challenge Phase 1b study in the U.S. in 2025 to evaluate CDI-988 as a norovirus prophylaxis and treatment. SARS-CoV-2 and Other Coronavirus Program By targeting viral replication enzymes and proteases, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including SARS-CoV-2 and its variants, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). CDI-988 showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses, as well as against noroviruses. The global COVID-19 therapeutics market is estimated to exceed $16 billion annually by the end of 2031. Oral pan-viral protease inhibitor CDI-988 for the treatment of coronaviruses and noroviruses CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and demonstrated a favorable safety profile and PK properties. In September 2023 we dosed the first healthy subject in our norovirus/coronavirus CDI-988 study, which is expected to serve as a Phase 1 study for both indications. In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study. In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a high-dose cohort. In August 2025 we presented favorable safety and tolerability Phase 1 data from all CDI-988 doses, including the high-dose 1200 mg cohort, at the MHSRS. Second Quarter Financial Results Research and development (R&D) expenses for the second quarter of 2025 were $1.1 million, compared with $4.3 million for the second quarter of 2024, with the decrease primarily due to the timing of clinical study costs. General and administrative (G&A) expenses for the second quarter of 2025 were $1.0 million, compared with $1.1 million for the second quarter of 2024, with the decrease primarily due to a reduction in salaries and wages. Net loss for the second quarter of 2025 was $2.1 million, or $0.20 per share, compared with net loss for the second quarter of 2024 of $5.3 million, or $0.53 per share. Six Months Financial Results R&D expenses for the first six months of 2025 were $2.5 million, compared with $7.3 million for the first six months of 2024. G&A expenses for the first half of 2025 were $2.0 million, compared with $2.3 million for the first half of 2024. Net loss for the first six months of 2025 was $4.4 million, or $0.43 per share, compared with a net loss for the first six months of 2024 of $9.3 million, or $0.91 per share. Cocrystal reported unrestricted cash as of June 30, 2025 of $4.8 million, compared with $9.9 million as of December 31, 2024. Net cash used in operating activities for the first six months of 2025 was $5.1 million, compared with $8.2 million for the first six months of 2024. The Company had working capital of $4.9 million and 10.2 million common shares outstanding as of June 30, 2025. About Cocrystal Pharma, Inc. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create viable antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans for the future development of preclinical and clinical product candidates including the potential of our norovirus product candidate, our plans to initiate a human Phase 1b challenge study for our norovirus product candidate, and our plans with regard to initiating a second human challenge study for CC-42344. The words "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "could," "target," "potential," "is likely," "will," "expect" and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from our need for additional capital to fund our operations over the next 12 months, inflation, the possibility of a recession, interest rate increases, imposed and threated tariffs, and geopolitical conflicts including those in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., UK, Australia and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials for and otherwise proceed with studies as well as similar problems with our vendors and our current and any future clinical research organization (CROs) and contract manufacturing organizations (CMOs), the progress and results of the studies including any adverse findings or delays, the ability of us and our CROs to recruit volunteers for, and to otherwise proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes and any adverse developments which may arise therefrom, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the potential for the development of effective treatments by competitors which could reduce or eliminate a prospective future market share commercializing any product candidates we may develop in the future, and our ability to meet our future liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Investor Contact: Alliance Advisors IR Jody Cain 310-691-7100 [email protected] Financial Tables to follow COCRYSTAL PHARMA, INC. CONSOLIDATED BALANCE SHEETS (in thousands) COCRYSTAL PHARMA, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except per share data) # # #

Investor releaseQuarter not tagged2025-08-05

Cocrystal Pharma Presents Phase 1 Results for Pan-Viral Inhibitor CDI-988 at Department of Defense Medical Conference

GlobeNewswire
All CDI-988 doses, ranging from 100 mg to 1200 mg, in the Phase 1 study were well tolerated Company expects to initiate Phase 1b study with CDI-988 in norovirus-infected healthy subjects later this year Lack of approved norovirus treatments or vaccines creates critical unmet medical need BOTHELL, Wash., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) announces the presentation of favorable safety and tolerability data from a randomized, double-blinded, placebo-controlled Phase 1 study with its oral, direct-acting pan-viral inhibitor CDI-988 at the 2025 Military Health System Research Symposium (MHSRS), being held August 4-7 in Kissimmee, Florida. The results support Cocrystal’s continued clinical development of CDI-988 as a potential norovirus prophylaxis and treatment. In An Oral Pan-viral Protease Inhibitor for the Prevention and Treatment of Norovirus and Coronavirus Infections: Mechanism of Action and Phase 1 Study Results, Sam Lee, Ph.D., Cocrystal President and co-CEO, discussed findings from the CDI-988 Phase 1 single-ascending (SAD) and multiple-ascending (MAD) cohorts. Data indicate that all doses, ranging from 100 mg to 1200 mg, were well tolerated. Overall treatment-emergent adverse events among CDI-988 subjects were 28% (10/36) compared with 40% (4/10) among placebo subjects for the SAD cohorts, and 53% (19/36) and 92% (11/12), respectively, for the MAD cohorts. Headache was the most common adverse event. All subjects in the SAD cohorts and all but one in the MAD cohorts completed the study. No severe treatment-emergent adverse events, no clinically relevant ECG changes and no clinically significant pathology results were reported from the CDI-988 Phase 1 single-ascending (SAD) and multiple-ascending (MAD) cohorts. “Consistent with interim results from the Phase 1 study, CDI-988 was well-tolerated with a favorable safety profile across all dose levels tested in this study,” said Dr. Lee. “Our plan to continue CDI-988’s clinical development for norovirus is particularly relevant for the military, where this highly transmissible pathogen poses significant operational and economic risks. In confined settings such as naval vessels and military installations, norovirus can rapidly spread, causing debilitating gastrointestinal symptoms that could compromise mission readiness. “The absence of approved norovirus treatments or vacc…Read full document

All CDI-988 doses, ranging from 100 mg to 1200 mg, in the Phase 1 study were well tolerated Company expects to initiate Phase 1b study with CDI-988 in norovirus-infected healthy subjects later this year Lack of approved norovirus treatments or vaccines creates critical unmet medical need BOTHELL, Wash., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) announces the presentation of favorable safety and tolerability data from a randomized, double-blinded, placebo-controlled Phase 1 study with its oral, direct-acting pan-viral inhibitor CDI-988 at the 2025 Military Health System Research Symposium (MHSRS), being held August 4-7 in Kissimmee, Florida. The results support Cocrystal’s continued clinical development of CDI-988 as a potential norovirus prophylaxis and treatment. In An Oral Pan-viral Protease Inhibitor for the Prevention and Treatment of Norovirus and Coronavirus Infections: Mechanism of Action and Phase 1 Study Results, Sam Lee, Ph.D., Cocrystal President and co-CEO, discussed findings from the CDI-988 Phase 1 single-ascending (SAD) and multiple-ascending (MAD) cohorts. Data indicate that all doses, ranging from 100 mg to 1200 mg, were well tolerated. Overall treatment-emergent adverse events among CDI-988 subjects were 28% (10/36) compared with 40% (4/10) among placebo subjects for the SAD cohorts, and 53% (19/36) and 92% (11/12), respectively, for the MAD cohorts. Headache was the most common adverse event. All subjects in the SAD cohorts and all but one in the MAD cohorts completed the study. No severe treatment-emergent adverse events, no clinically relevant ECG changes and no clinically significant pathology results were reported from the CDI-988 Phase 1 single-ascending (SAD) and multiple-ascending (MAD) cohorts. “Consistent with interim results from the Phase 1 study, CDI-988 was well-tolerated with a favorable safety profile across all dose levels tested in this study,” said Dr. Lee. “Our plan to continue CDI-988’s clinical development for norovirus is particularly relevant for the military, where this highly transmissible pathogen poses significant operational and economic risks. In confined settings such as naval vessels and military installations, norovirus can rapidly spread, causing debilitating gastrointestinal symptoms that could compromise mission readiness. “The absence of approved norovirus treatments or vaccines creates a critical unmet medical need,” he added. “Norovirus presents significant vaccine development challenges due to its high genetic variability and mutation rate. CDI-988's mechanism of action targeting viral replication and its broad-spectrum coverage offers a promising solution as a potential prophylactic and therapeutic intervention across all norovirus genogroups including GII.4 and GII.17. This could be a new approach to outbreak prevention and management. We expect to initiate a Phase 1b challenge study with CDI-988 in norovirus-infected healthy subjects later this year.” MHSRS is an annual educational symposium with approximately 4,000 attendees that provides a collaborative environment for military medical care providers with deployment experience, research and academic scientists, international partners and industry on research and related healthcare initiatives falling under the topic areas of combat casualty care, military operational medicine, clinical and rehabilitative medicine, information sciences, military infectious diseases and radiation health effects. More information is available here. Pan-viral Protease Inhibitor CDI-988 CDI-988 was designed and developed with Cocrystal’s proprietary structure-based platform technology as a broad-spectrum inhibitor to a highly conserved region in the active site of 3CL viral proteases. Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 represents a compelling first potential oral treatment for noroviruses, and for coronaviruses. Norovirus Infection Norovirus is a common and highly contagious virus that afflicts people of all ages and causes symptoms of acute gastroenteritis including nausea, vomiting, stomach pain and diarrhea, as well as fatigue, fever and dehydration. Norovirus outbreaks occur most commonly in semi-closed communities such as hospitals, nursing homes, childcare facilities, cruise ships, schools and disaster relief sites. Norovirus infections are estimated to cost society approximately $60 billion annually worldwide. Structure-Based Drug Discovery Platform Technology Cocrystal’s proprietary structural biology, along with its expertise in enzymology and medicinal chemistry, enable its development of novel antiviral agents. The Company’s platform provides a three-dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide Structure Activity Relationships. This helps to identify novel binding sites and allows for a rapid turnaround of structural information through highly automated X-ray data processing and refinement. The goal of this technology is to facilitate the development of novel broad-spectrum antivirals for the treatment of acute and chronic viral diseases. About Cocrystal Pharma, Inc. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential efficacy of CDI-988 as a potential breakthrough for norovirus prophylaxis and treatment, and the potential characteristics of and market for such product candidate and the Company’s plan to initiate a Phase 1b study in 2025. The words "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "could," "target," "potential," "is likely," "will," "expect" and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, our need for additional capital to fund our operations over the next 12 months, risks relating to our ability to obtain regulatory approval for and proceed with clinical trials including recruiting volunteers and procuring materials for such studies by our clinical research organizations and vendors, the results of such studies, our and our collaboration partners’ technology and software performing as expected, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes, and potential development of effective treatments and/or vaccines by competitors, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the impact of the Trump Administration’s policies and actions on regulation affecting the FDA and other healthcare agencies and potential staffing issues resulting therefrom, as well as other government actions such as tariffs which may cause delays or force us to incur additional costs to proceed without development programs. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Investor Contact: Alliance Advisors IR Jody Cain 310-691-7100 [email protected] # # #

Investor releaseQuarter not tagged2025-05-27

COCP: Topline Results for High-Dose Cohort from Phase 1 Trial of CDI-988 Expected in 2Q25…

Zacks Small Cap Research
By David Bautz, PhD NASDAQ:COCP READ THE FULL COCP RESEARCH REPORT Business Update Update on CDI-988 In January 2025, Cocrystal Pharma, Inc. (NASDAQ:COCP) announced results from the Phase 1 trial of CDI-988 for the prophylaxis and treatment of norovirus, coronavirus, and other viral infections. The results showed the drug had a favorable safety and tolerability profile for dosing up to 800 mg per day for 10 consecutive days. The company also announced that an additional cohort that will receive a dose of 1,200 mg and a shorter treatment duration of five consecutive days and we anticipate those results in the second quarter of 2025. In addition, Cocrystal is planning to initiate a human challenge study in norovirus-infected individuals to evaluate CDI-988 as a treatment and prophylaxis later in 2025. There are no approved therapies for norovirus infection, which is the most common cause of acute gastroenteritis. According to the Centers for Disease Control (CDC), there are an estimated 685 million cases and 200,000 deaths caused by norovirus infection each year worldwide. In the U.S., norovirus infection causes over 2 million outpatient clinical visits annually and approximately 100,000 hospitalizations. In December 2024 alone, there were a reported 900 cruise ship passengers sickened from norovirus outbreaks. In addition to potentially being utilized as a norovirus therapy, CDI-988 may be tested as a prophylactic to be used in population dense areas to prevent norovirus outbreaks (e.g., cruise ships, nursing homes, day cares, military installations). CDI-988 was developed using Cocrystal’s proprietary drug discovery platform technology. It binds to a highly conserved region in the active site of noroviruses and coronaviruses 3CL viral proteases and exhibits pan-viral activity against pandemic norovirus and coronavirus strains. Phase 2a Trial of CC-42344 Extended In December 2024, Cocrystal announced that the Phase 2a clinical trial of its oral PB2 inhibitor, CC-42344, will be extended due to unexpectedly low infection rates among trial participants that were challenged with a H3N2 influenza strain. The Phase 2a trial initiated in December 2023 and completed enrollment in May 2024 with 78 total participants. It is a single center study being conducted in the U.K. designed to test the safety, tolerability, pharmacokinetics (PK), antiviral activity, and clinica…Read full document

By David Bautz, PhD NASDAQ:COCP READ THE FULL COCP RESEARCH REPORT Business Update Update on CDI-988 In January 2025, Cocrystal Pharma, Inc. (NASDAQ:COCP) announced results from the Phase 1 trial of CDI-988 for the prophylaxis and treatment of norovirus, coronavirus, and other viral infections. The results showed the drug had a favorable safety and tolerability profile for dosing up to 800 mg per day for 10 consecutive days. The company also announced that an additional cohort that will receive a dose of 1,200 mg and a shorter treatment duration of five consecutive days and we anticipate those results in the second quarter of 2025. In addition, Cocrystal is planning to initiate a human challenge study in norovirus-infected individuals to evaluate CDI-988 as a treatment and prophylaxis later in 2025. There are no approved therapies for norovirus infection, which is the most common cause of acute gastroenteritis. According to the Centers for Disease Control (CDC), there are an estimated 685 million cases and 200,000 deaths caused by norovirus infection each year worldwide. In the U.S., norovirus infection causes over 2 million outpatient clinical visits annually and approximately 100,000 hospitalizations. In December 2024 alone, there were a reported 900 cruise ship passengers sickened from norovirus outbreaks. In addition to potentially being utilized as a norovirus therapy, CDI-988 may be tested as a prophylactic to be used in population dense areas to prevent norovirus outbreaks (e.g., cruise ships, nursing homes, day cares, military installations). CDI-988 was developed using Cocrystal’s proprietary drug discovery platform technology. It binds to a highly conserved region in the active site of noroviruses and coronaviruses 3CL viral proteases and exhibits pan-viral activity against pandemic norovirus and coronavirus strains. Phase 2a Trial of CC-42344 Extended In December 2024, Cocrystal announced that the Phase 2a clinical trial of its oral PB2 inhibitor, CC-42344, will be extended due to unexpectedly low infection rates among trial participants that were challenged with a H3N2 influenza strain. The Phase 2a trial initiated in December 2023 and completed enrollment in May 2024 with 78 total participants. It is a single center study being conducted in the U.K. designed to test the safety, tolerability, pharmacokinetics (PK), antiviral activity, and clinical measurements of CC-42344. The results of the trial showed that CC-42344 had a favorable safety and tolerability profile as no participants had serious adverse events or discontinued the trial due to drug-related adverse events, however due to the low infectivity rate the virology results were not interpretable. The company will be working with the contract research organization to amend the trial protocol to help ensure that there is a higher infectivity rate during the rest of the study. We anticipate the protocol amendment will be completed in time to continue the trial in mid-2025. Background on CC-42344 CC-42344 is a broad-spectrum inhibitor of pandemic and seasonal strains of influenza A. It targets subunit PB2, which along with PA and PB1 forms the RNA-dependent RNA polymerase. This enzyme is essential for viral replication in cells by replicating the viral RNA segments and transcribing their genes, which makes it an attractive target for therapeutic intervention. The following figure shows CC-42344 binding to the highly conserved active site of the PB2 protein in different influenza strains. Binding to this conserved active site leads to broad-spectrum antiviral activity against multiple Influenza A strains, including both pandemic and seasonal strains. The following table shows the strains that CC-42344 is active against, which includes strains that are resistant to oseltamivir and baloxavir. Financial Update On May 15, 2025, Cocrystal announced financial results for the first quarter of 2025. As expected, the company did not report any revenues in the first quarter of 2025. R&D expenses in the first quarter of 2025 were $1.4 million, compared to $3.0 million in the first quarter of 2024. The decrease was primarily due to a reduction in personnel costs and the timing of clinical trial costs. G&A expenses in the first quarter of 2025 were $1.0 million, compared to $1.2 million for the first quarter of 2024. The decrease was primarily due to a reduction in insurance costs and other expenses. As of March 31, 2025, Cocrystal had approximately $6.9 million in cash and cash equivalents. As of May 15, 2025, Cocrystal had approximately 10.2 million shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of 11.0 million shares. Conclusion Cocrystal has a number of milestones upcoming in 2025, including data from the high-dose cohort of the Phase 1 trial of CDI-988, which we expect in the second quarter of 2025. In addition, we anticipate additional details on the planned human norovirus challenge study to evaluate CDI-988 as both a treatment and prophylaxis therapy, which is planned for later in 2025. Lastly, we anticipate updates regarding the Phase 2a challenge study of CC-42344. With no changes to our model our valuation remains at $8 per share. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR.  DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.

Investor releaseQuarter not tagged2025-05-15

Cocrystal Pharma Reports First Quarter 2025 Financial Results and Provides Updates on its Antiviral Drug-Development Programs

GlobeNewswire
In vitro testing with CDI-988 demonstrated superior broad-spectrum antiviral activity against major norovirus variants BOTHELL, Wash., May 15, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the three months ended March 31, 2025, and provides updates on its antiviral product pipeline, upcoming milestones and business activities. “Our oral pan-viral protease inhibitor CDI-988 is a potential breakthrough first-in-class treatment and prophylaxis for norovirus, a debilitating gastrointestinal infection that strikes millions globally each year,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “By precisely targeting the virus' core replication machinery, we believe CDI-988 effectively combats all major strains of this highly contagious pathogen with exceptional in vitro activity demonstrated against the current circulating GII.17 and GII.4 strains. We're preparing to launch a U.S. human challenge study in the coming months – a critical step in advancing this transformative therapy to patients worldwide. “Our novel, broad-spectrum drug candidates have the potential to fundamentally transform how we fight viral threats worldwide,” said James Martin, CFO and co-CEO of Cocrystal. “We’re advancing development of these assets for multibillion-dollar markets while remaining committed to a capital-efficient business model to maximize shareholder value.” Antiviral Product Pipeline Overview We harness our revolutionary structure-based drug discovery platform technology to engineer next-generation, broad-spectrum antivirals that precisely disrupt viral replication mechanisms. Unlike traditional approaches, our platform technology identifies compounds that bind to highly conserved regions of viral enzymes, thereby creating a formidable defense against current viral threats as well as their mutations. By specifically targeting these evolutionary-constrained viral regions, our candidates maintain efficacy even as viruses mutate, while simultaneously minimizing off-target interactions that typically lead to adverse side effects. This dual advantage represents a significant breakthrough in antiviral drug development. Our innovative methodology fundamentally transforms the conventional drug discovery paradigm by eliminating the inefficient, resource-intensive cycles of high-throughput compound sc…Read full document

In vitro testing with CDI-988 demonstrated superior broad-spectrum antiviral activity against major norovirus variants BOTHELL, Wash., May 15, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the three months ended March 31, 2025, and provides updates on its antiviral product pipeline, upcoming milestones and business activities. “Our oral pan-viral protease inhibitor CDI-988 is a potential breakthrough first-in-class treatment and prophylaxis for norovirus, a debilitating gastrointestinal infection that strikes millions globally each year,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “By precisely targeting the virus' core replication machinery, we believe CDI-988 effectively combats all major strains of this highly contagious pathogen with exceptional in vitro activity demonstrated against the current circulating GII.17 and GII.4 strains. We're preparing to launch a U.S. human challenge study in the coming months – a critical step in advancing this transformative therapy to patients worldwide. “Our novel, broad-spectrum drug candidates have the potential to fundamentally transform how we fight viral threats worldwide,” said James Martin, CFO and co-CEO of Cocrystal. “We’re advancing development of these assets for multibillion-dollar markets while remaining committed to a capital-efficient business model to maximize shareholder value.” Antiviral Product Pipeline Overview We harness our revolutionary structure-based drug discovery platform technology to engineer next-generation, broad-spectrum antivirals that precisely disrupt viral replication mechanisms. Unlike traditional approaches, our platform technology identifies compounds that bind to highly conserved regions of viral enzymes, thereby creating a formidable defense against current viral threats as well as their mutations. By specifically targeting these evolutionary-constrained viral regions, our candidates maintain efficacy even as viruses mutate, while simultaneously minimizing off-target interactions that typically lead to adverse side effects. This dual advantage represents a significant breakthrough in antiviral drug development. Our innovative methodology fundamentally transforms the conventional drug discovery paradigm by eliminating the inefficient, resource-intensive cycles of high-throughput compound screening and prolonged hit-to-lead optimization. The result is faster identification of promising candidates with superior resistance profiles and safety characteristics. Influenza ProgramsInfluenza is a major global health threat that may become more challenging to treat due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Each year there are approximately 1 billion cases of seasonal influenza worldwide, 3-5 million severe illnesses and up to 650,000 deaths. On average, about 8% of the U.S. population contracts influenza each season. In addition to the health risk, influenza is responsible for an estimated $11.2 billion in direct and indirect costs in the U.S. annually. Oral CC-42344 for the treatment of pandemic and seasonal influenza A Our novel PB2 inhibitor CC-42344 showed excellent in vitro activity against pandemic and seasonal influenza A strains, as well as strains that are resistant to Tamiflu® and Xofluza®. In December 2022 we reported favorable safety and tolerability results from the oral CC-42344 Phase 1 study. In December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, viral and clinical measurements of CC-42344 in influenza A-infected subjects in the United Kingdom, following authorization from the UK Medicines and Healthcare Products Regulatory Agency (MHRA). In May 2024 we completed enrollment in the Phase 2a human challenge study. In June 2024 we reported that in vitro studies demonstrated CC-42344 inhibits the activity of the highly pathogenic avian influenza A (H5N1) PB2 protein identified in humans exposed to infected dairy cows. In December 2024 we announced a plan to extend the CC-42344 Phase 2a human challenge study due to unexpectedly low influenza infection among study participants. Inhaled CC-42344 as prophylaxis and treatment for pandemic and seasonal influenza A Our preclinical testing showed superior pulmonary pharmacology with CC-42344, including high exposure to drug and a long half-life. Dry powder inhalation formulation development and toxicology studies have been completed. Influenza A/B program Our efforts to develop a preclinical lead of novel influenza replication inhibitors are ongoing. Norovirus ProgramNorovirus is a common and highly contagious virus that causes symptoms of acute gastroenteritis among people of all ages including nausea, vomiting, stomach pain and diarrhea as well as fatigue, fever and dehydration. Norovirus infection can be significantly more severe and prolonged in specific risk groups including infants, children, the elderly and people with immunodeficiency. Norovirus outbreaks occur most commonly in semi-closed communities and have become notorious for their occurrence in hospitals, nursing homes, childcare facilities, cruise ships, schools, disaster relief sites and military settings. In the U.S. alone, noroviruses are responsible for an estimated 21 million cases annually, including 109,000 hospitalizations, 465,000 emergency department visits and an estimated 900 deaths. The annual burden of norovirus to the U.S. is estimated at $10.6 billion. Noroviruses are responsible for up to 1.1 million hospitalizations and 218,000 deaths annually in children in the developing world. There is currently no effective treatment or effective vaccine for norovirus, and the ability to curtail outbreaks is limited. Oral pan-viral protease inhibitor CDI-988 for the treatment of noroviruses and coronaviruses Our novel, broad-spectrum protease inhibitor CDI-988 is being evaluated as a potential oral treatment for noroviruses and coronaviruses. CDI-988 has shown in vitro pan-viral activity against multiple norovirus strains. In May 2023 we announced approval of our application to the Australian regulatory agency for a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability and pharmacokinetics (PK) of oral CDI-988 in healthy subjects. In August 2023 we announced our selection of CDI-988 as our lead compound for the oral treatment for noroviruses, in addition to coronaviruses. In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study. In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a high-dose cohort. In April 2025 we announced that CDI-988 showed superior broad-spectrum antiviral activity against GII.17 strains, the most prevalent strain in the U.S. and European countries in 2024-2025. We expect to report topline oral CDI-988 Phase 1 results from the high-dose healthy subject cohort in the second quarter of 2025. We plan to initiate a human challenge study in the U.S. in the coming months to evaluate CDI-988 as a norovirus treatment and prophylaxis. SARS-CoV-2 and Other Coronavirus ProgramBy targeting viral replication enzymes and proteases, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including SARS-CoV-2 and its variants, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). CDI-988 showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses, as well as against noroviruses. The global COVID-19 therapeutics market is estimated to exceed $16 billion annually by the end of 2031. Oral pan-viral protease inhibitor CDI-988 for the treatment of coronaviruses and noroviruses CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and demonstrated a favorable safety profile and PK properties. In September 2023 we dosed the first healthy subject in our dual pan-norovirus/pan-coronavirus oral CDI-988 study, which is expected to serve as a Phase 1 study for both indications. In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study. In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a high-dose cohort. We expect to report topline oral CDI-988 Phase 1 results from the high-dose healthy subject cohort in the second quarter of 2025. First Quarter Financial Results Research and development (R&D) expenses for the first quarter of 2025 were $1.4 million, compared with $3.0 million for the first quarter of 2024, with the decrease primarily due to a reduction in personnel costs and the timing of clinical study costs. General and administrative (G&A) expenses for the first three months of 2025 were $1.0 million, compared with $1.2 million for the first three months of 2024, with the decrease primarily due to a reduction in insurance costs and other expenses. Net loss for the first quarter of 2025 was $2.3 million, or $0.23 per share, compared with net loss for the first quarter of 2024 of $4.0 million, or $0.39 per share. Cocrystal reported unrestricted cash as of March 31, 2025 of $6.9 million, compared with $9.9 million as of December 31, 2024. Net cash used in operating activities for the first quarter of 2025 was $2.9 million, compared with $4.5 million for the first quarter of 2024. The Company had working capital of $6.9 million and 10.2 million common shares outstanding as of March 31, 2025. About Cocrystal Pharma, Inc. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. For further information about Cocrystal, please visit www.cocrystalpharma.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans for the future development of preclinical and clinical product candidates including the potential of our norovirus product candidate, our plans to initiate a human challenge study for our norovirus product candidate, and our plans with regard to initiating a second human challenge study for CC-42344 The words "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "could," "target," "potential," "is likely," "will," "expect" and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from our need for additional capital to fund our operations over the next 12 months, inflation, the possibility of a recession, interest rate increases, imposed and threated tariffs, and geopolitical conflicts including those in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., UK, Australia and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials for and otherwise proceed with studies as well as similar problems with our vendors and our current and any future clinical research organization (CROs) and contract manufacturing organizations (CMOs), the progress and results of the studies for CC-42344 and CDI-988 including the delay of the Phase 2a study for CC-42344 which may require us to incur substantial additional costs, the ability of us and our CROs to recruit volunteers for, and to otherwise proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes including potential downward pressure on government spending on the biopharmaceutical and healthcare industry based on policies and actions taken by the Trump Administration in the U.S., the impact of the Trump Administration’s policies and actions on regulation affecting the FDA and other healthcare agencies and potential staffing issues resulting therefrom, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the potential for the development of effective treatments by competitors which could reduce or eliminate a prospective future market share commercializing any product candidates we may develop in the future, and our ability to meet our future liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Investor Contact:Alliance Advisors IRJody [email protected] Financial Tables to followCOCRYSTAL PHARMA, INC. CONSOLIDATED BALANCE SHEETS(in thousands) COCRYSTAL PHARMA, INC. CONSOLIDATED STATEMENTS OF OPERATIONS(unaudited)(in thousands, except per share data) # # #

Investor releaseQuarter not tagged2025-03-31

Cocrystal Pharma Reports 2024 Financial Results and Provides Updates on its Antiviral Drug-Development Programs

GlobeNewswire
BOTHELL, Wash., March 31, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the 12 months ended December 31, 2024, and provides updates on its antiviral product pipeline, upcoming milestones and business activities. “Our novel, potent antiviral compounds for norovirus, influenza and coronavirus address critical gaps in global health where effective treatments or vaccines are currently lacking,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “We plan to initiate a norovirus human challenge study in the U.S. later this year to evaluate our pan-viral protease inhibitor CDI-988 for the potential treatment and prevention of norovirus infection. The big surge in reported norovirus outbreaks is possibly due to norovirus variants switching from GII.4 to GII.17, as well as increased social gathering after the COVID-19 pandemic. Norovirus is the most common cause of acute gastroenteritis and there are no approved therapeutics or vaccines, making it a compelling target. “We are optimistic that our oral PB2 inhibitor CC-42344 will have potential as a treatment for seasonal influenza A infection and pandemic avian influenza,” he added. “Following the unexpected low infection rate from the Phase 2a challenge study that precluded us from obtaining meaningful human efficacy data, we plan to continue the influenza challenge study.” “News coverage in recent months of norovirus and avian flu outbreaks underscore the urgent need for new antiviral solutions,” said James Martin, CFO and co-CEO of Cocrystal. “We are advancing our first- and best-in-class antiviral drug compounds that were designed using our Nobel Prize-winning structure-based technologies for these high-value viral targets that address multibillion-dollar markets.” Antiviral Product Pipeline Overview We apply our proprietary structure-based drug discovery platform technology for developing broad-spectrum antivirals that inhibit viral replication. By designing and selecting candidates that target highly conserved regions of the viral enzymes, we seek to develop drugs that are effective against the virus and mutations of the virus, while reducing off-target interactions that may cause undesirable side effects. Our drug discovery process differs from traditional, empirical medicinal chemistry approaches that often require iterative hi…Read full document

BOTHELL, Wash., March 31, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the 12 months ended December 31, 2024, and provides updates on its antiviral product pipeline, upcoming milestones and business activities. “Our novel, potent antiviral compounds for norovirus, influenza and coronavirus address critical gaps in global health where effective treatments or vaccines are currently lacking,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “We plan to initiate a norovirus human challenge study in the U.S. later this year to evaluate our pan-viral protease inhibitor CDI-988 for the potential treatment and prevention of norovirus infection. The big surge in reported norovirus outbreaks is possibly due to norovirus variants switching from GII.4 to GII.17, as well as increased social gathering after the COVID-19 pandemic. Norovirus is the most common cause of acute gastroenteritis and there are no approved therapeutics or vaccines, making it a compelling target. “We are optimistic that our oral PB2 inhibitor CC-42344 will have potential as a treatment for seasonal influenza A infection and pandemic avian influenza,” he added. “Following the unexpected low infection rate from the Phase 2a challenge study that precluded us from obtaining meaningful human efficacy data, we plan to continue the influenza challenge study.” “News coverage in recent months of norovirus and avian flu outbreaks underscore the urgent need for new antiviral solutions,” said James Martin, CFO and co-CEO of Cocrystal. “We are advancing our first- and best-in-class antiviral drug compounds that were designed using our Nobel Prize-winning structure-based technologies for these high-value viral targets that address multibillion-dollar markets.” Antiviral Product Pipeline Overview We apply our proprietary structure-based drug discovery platform technology for developing broad-spectrum antivirals that inhibit viral replication. By designing and selecting candidates that target highly conserved regions of the viral enzymes, we seek to develop drugs that are effective against the virus and mutations of the virus, while reducing off-target interactions that may cause undesirable side effects. Our drug discovery process differs from traditional, empirical medicinal chemistry approaches that often require iterative high-throughput compound screening and lengthy hit-to-lead processes. Influenza Programs Influenza is a major global health threat that may become more challenging to treat due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Each year there are approximately 1 billion cases of seasonal influenza worldwide, 3-5 million severe illnesses and up to 650,000 deaths. On average, about 8% of the U.S. population contracts influenza each season. In addition to the health risk, influenza is responsible for an estimated $11.2 billion in direct and indirect costs in the U.S. annually. Oral CC-42344 for the treatment of pandemic and seasonal influenza A Our novel PB2 inhibitor CC-42344 showed excellent in vitro antiviral activity against pandemic and seasonal influenza A strains, as well as strains that are resistant to Tamiflu® and Xofluza®. In December 2022 we reported favorable safety and tolerability results from the oral CC-42344 Phase 1 study. In December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, viral and clinical measurements of CC-42344 in influenza A-infected subjects in the United Kingdom, following authorization from the UK Medicines and Healthcare Products Regulatory Agency (MHRA). In May 2024 we completed enrollment in the Phase 2a human challenge study. In June 2024 we reported that in vitro studies demonstrated CC-42344 inhibits the activity of the highly pathogenic avian influenza A (H5N1) PB2 protein identified in humans exposed to infected dairy cows. In December 2024 we announced a plan to extend the CC-42344 human challenge study due to unexpectedly low influenza infection among study participants. Inhaled CC-42344 as prophylaxis and treatment for pandemic and seasonal influenza A Our preclinical testing showed superior pulmonary pharmacology with CC-42344 including high exposure to drug and a long half-life. We have completed CC-42344 inhalation formulation development and GLP toxicology studies. Influenza A/B program Our efforts to develop a preclinical lead of novel influenza replication inhibitors are ongoing. Norovirus Program Norovirus symptoms can include severe nausea, vomiting and diarrhea. An estimated 685 million cases and an estimated 50,000 child deaths worldwide are attributed to norovirus each year, with an estimated societal cost of $60 billion. By targeting viral replication, we believe it is possible to develop an effective treatment and/or prophylaxis for closed environments for all genogroups of norovirus. Oral pan-viral protease inhibitor CDI-988 for the treatment of noroviruses and coronaviruses Our novel, broad-spectrum protease inhibitor CDI-988 is being evaluated as a potential oral treatment for noroviruses and coronaviruses. CDI-988 has shown in vitro pan-viral activity against multiple norovirus strains. In May 2023 we announced approval of our application to the Australian regulatory agency for a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability and pharmacokinetics (PK) of oral CDI-988 in healthy volunteers. In August 2023 we announced our selection of CDI-988 as our lead compound for the oral treatment for noroviruses, in addition to coronaviruses. In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study. In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a higher-dose cohort. We expect to report topline results from the high-dose healthy volunteer cohort with CDI-988 in the second quarter of 2025. We plan to initiate a human challenge study in the U.S. in 2025 to evaluate CDI-988 as a norovirus treatment and prophylaxis. SARS-CoV-2 and Other Coronavirus Programs By targeting viral replication enzymes and proteases, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including SARS-CoV-2 and its variants, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). CDI-988 showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses, as well as against noroviruses. The global COVID-19 therapeutics market is estimated to exceed $16 billion annually by the end of 2031. Oral pan-viral protease inhibitor CDI-988 for the treatment of coronaviruses and noroviruses CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and demonstrated a favorable safety profile and PK properties. In September 2023 we dosed the first healthy subject in our dual pan-norovirus/pan-coronavirus oral CDI-988 study, which is expected to serve as a Phase 1 study for both indications. In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohort in the Phase 1 study. In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a higher-dose cohort. We expect to report topline results from the higher dose cohort in the CDI-988 Phase 1 study in the second quarter of 2025. 2024 Financial Results Research and development (R&D) expenses for 2024 were $12.5 million, compared with $15.2 million for 2023. The decrease was primarily due to the timing of clinical study costs. General and administrative (G&A) expenses for 2024 were $5.3 million, compared with $6.0 million for 2023, with the $0.7 million decrease primarily due to a reduction of insurance costs and other expenses. During 2023 the Company received $2.6 million related to litigation with an insurer. The net loss for 2024 was $17.5 million, or $1.72 per share, compared with the net loss for 2023 of $18.0 million, or $1.87 per share. For 2024 the year over-year-net loss was reduced by $3.1 million exclusive of the $2.6 million received in 2023 noted above. Cocrystal reported unrestricted cash as of December 31, 2024 of $9.9 million, compared with $26.4 million as of December 31, 2023. Net cash used in operating activities for 2024 was $16.5 million, compared with $14.7 million for 2023. The Company had working capital of $9.2 million and 10.2 million common shares outstanding as of December 31, 2024. About Cocrystal Pharma, Inc. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. For further information about Cocrystal, please visit www.cocrystalpharma.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans for the future development of preclinical and clinical product candidates, our expectations regarding future characteristics of the product candidates we develop, the expected time of achieving certain value-driving milestones in our programs, including preparation, commencement and advancement of clinical studies for certain product candidates in 2025, our plans regarding further clinical development of such product candidates, and the viability and efficacy of potential treatments for diseases our product candidates are designed to treat, and expectations for the markets for certain therapeutics. The words "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "could," "target," "potential," "is likely," "will," "expect" and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from our need for additional capital to fund our operations over the next 12 months, inflation, the possibility of a recession, interest rate increases, imposed and threated tariffs, and geopolitical conflicts including those in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., UK, Australia and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials for and otherwise proceed with studies as well as similar problems with our vendors and our current and any future clinical research organization (CROs) and contract manufacturing organizations (CMOs), the progress and results of the studies for CC-42344 and CDI-988 including the delay of the Phase 2a study for CC-42344 which may require us to incur substantial additional costs, the ability of us and our CROs to recruit volunteers for, and to otherwise proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes including potential downward pressure on government spending on the biopharmaceutical and healthcare industry based on policies and actions taken by the Trump Administration in the U.S., the impact of the Trump Administration’s policies and actions on regulation affecting the FDA and other healthcare agencies and potential staffing issues resulting therefrom, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, and the potential for the development of effective treatments by competitors which could reduce or eliminate a prospective future market share commercializing any product candidates we may develop in the future. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Investor Contact:Alliance Advisors IRJody [email protected] Financial Tables to follow COCRYSTAL PHARMA, INC. CONSOLIDATED BALANCE SHEETS(in thousands) COCRYSTAL PHARMA, INC. CONSOLIDATED STATEMENTS OF OPERATIONS(unaudited)(in thousands, except per share data) # # #

As of 2026-05-30 • Updated weeklySource: Earnings sourceIngestion runbook