Cocrystal(COCP) - 2025 Q2 - Quarterly Results

Company Update and Pipeline Progress Cocrystal Pharma updates on Q2 2025 financial results and progress across its antiviral drug-development pipeline, utilizing its proprietary drug discovery platform Corporate Highlights and Strategic Direction Cocrystal Pharma reported its second quarter 2025 financial results and provided updates on its antiviral drug-development programs, emphasizing the progress of CDI-988 for norovirus and the company's proprietary structure-based drug discovery platform - Preparations are underway for a Phase 1b norovirus challenge study to evaluate the oral antiviral candidate CDI-988 as a prophylaxis and treatment, following favorable safety and tolerability results from its Phase 1 study[2][5] - Cocrystal's proprietary structure-based drug discovery platform technology engineers next-generation, broad-spectrum antivirals by targeting highly conserved regions of viral enzymes, aiming for efficacy against mutations and minimized off-target interactions[4] - The absence of approved norovirus treatments or vaccines creates a substantial market opportunity, with norovirus causing 685 million global cases annually and a $60 billion worldwide economic impact[4] Antiviral Drug-Development Programs Overview Cocrystal Pharma leverages its revolutionary, structure-based drug discovery platform to develop broad-spectrum antivirals, focusing on influenza, norovirus, and coronaviruses, by precisely disrupting viral replication mechanisms in highly conserved regions to combat resistance and improve safety - The drug discovery platform identifies compounds that bind to highly conserved regions of viral enzymes, providing defense against current viral threats and their mutations while minimizing adverse side effects[4] - This innovative methodology streamlines drug discovery by eliminating inefficient high-throughput screening, resulting in faster identification of promising candidates with superior resistance profiles and safety characteristics[4] Norovirus Program (CDI-988) The norovirus program, centered on the oral pan-viral protease inhibitor CDI-988, is advancing with favorable Phase 1 safety and tolerability results, and a Phase 1b human challenge study is planned for prophylaxis and treatment. CDI-988 has demonstrated potent in vitro activity against newly re-emerging GII.17 strains - Favorable safety and tolerability results from the single-ascending and multiple-ascending dose cohorts of the Phase 1 study for CDI-988 have been reported, including a high-dose 1200 mg cohort[13][14] - A human challenge Phase 1b study in the U.S. is planned for 2025 to evaluate CDI-988 as a norovirus prophylaxis and treatment[5][13] - CDI-988 has shown superior broad-spectrum antiviral activity against GII.17 strains, which were the most prevalent in the U.S. and Europe during 2024-2025 outbreaks[3][13] - Noroviruses are responsible for an estimated 21 million infections annually in the U.S., including 109,000 hospitalizations and 900 deaths, with an annual economic burden of $10.6 billion[9] Influenza Programs (CC-42344) Cocrystal's influenza programs, featuring oral and inhaled CC-42344, target pandemic and seasonal influenza A, including strains resistant to Tamiflu® and Xofluza®. The oral CC-42344 Phase 2a human challenge study is ongoing, and preclinical development for an inhaled formulation, including toxicology studies, has been completed - Oral CC-42344 demonstrated excellent in vitro activity against pandemic and seasonal influenza A strains, as well as strains resistant to Tamiflu® and Xofluza®[10] - The Phase 2a human challenge study for oral CC-42344 completed enrollment in May 2024, with a plan to extend the study due to unexpectedly low influenza infection among participants[10] - CC-42344 was shown to inhibit the activity of the highly pathogenic avian influenza A (H5N1) PB2 protein and was active against the 2024 Texas H5N1 avian influenza strain[10] - Preclinical testing for inhaled CC-42344 showed superior pulmonary pharmacology, including high drug exposure and a long half-life, with dry powder inhalation formulation development and toxicology studies completed[10] - Influenza causes approximately 1 billion cases globally each year, 3-5 million severe illnesses, up to 650,000 deaths, and an estimated $10.4 billion in direct medical costs in the U.S. annually[7] SARS-CoV-2 and Other Coronavirus Program (CDI-988) The SARS-CoV-2 and other coronavirus program utilizes CDI-988, a pan-viral protease inhibitor, which has demonstrated potent in vitro activity against SARS-CoV-2 and common human coronaviruses. The ongoing Phase 1 study for CDI-988 is designed to serve both norovirus and coronavirus indications - CDI-988 showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses, respiratory enteroviruses, and noroviruses[11] - CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and demonstrated a favorable safety profile and pharmacokinetic (PK) properties[14] - The global COVID-19 therapeutics market is estimated to exceed $16 billion annually by the end of 2031[11] - The Phase 1 study for CDI-988, which began dosing in September 2023, is expected to serve as a Phase 1 study for both norovirus and coronavirus indications[14] Financial Results Cocrystal Pharma reports its financial performance for Q2 and H1 2025, detailing reduced net losses and operating expenses, alongside changes in cash and balance sheet metrics Second Quarter 2025 Financial Performance Cocrystal Pharma reported a significant reduction in net loss for the second quarter of 2025 compared to the same period in 2024, primarily driven by decreased research and development (R&D) expenses due to the timing of clinical study costs and lower general and administrative (G&A) expenses | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change | | :----------------------- | :--------------------- | :--------------------- | :----- | | Research and development | $1,122 | $4,308 | -73.9% | | General and administrative | $986 | $1,140 | -13.4% | | Net loss | $(2,055) | $(5,343) | -61.5% | | Net loss per common share | $(0.20) | $(0.53) | -62.3% | - The decrease in R&D expenses was primarily due to the timing of clinical study costs[12] - The decrease in G&A expenses was primarily due to a reduction in salaries and wages[12] Six Months Ended June 30, 2025 Financial Performance For the first six months of 2025, Cocrystal Pharma continued to show a substantial reduction in net loss and operating expenses compared to the prior year's period, although its unrestricted cash reserves decreased significantly from the end of 2024 | Metric | H1 2025 (in thousands) | H1 2024 (in thousands) | Change | | :----------------------- | :--------------------- | :--------------------- | :----- | | Research and development | $2,482 | $7,258 | -65.8% | | General and administrative | $1,967 | $2,348 | -16.2% | | Net loss | $(4,356) | $(9,299) | -53.1% | | Net loss per common share | $(0.43) | $(0.91) | -52.8% | | Metric | June 30, 2025 (in thousands) | Dec 31, 2024 (in thousands) | Change | | :--------------------------- | :--------------------------- | :-------------------------- | :----- | | Unrestricted Cash | $4,800 | $9,900 | -51.5% | | Net cash used in operating activities (H1) | $5,100 | $8,200 | -37.8% | - The Company had working capital of $4.9 million and 10.2 million common shares outstanding as of June 30, 2025[17] Consolidated Financial Statements This section presents the detailed consolidated financial statements, including the balance sheets as of June 30, 2025, and December 31, 2024, and the statements of operations for the three and six months ended June 30, 2025 and 2024 Consolidated Balance Sheets The consolidated balance sheet shows a decrease in total assets and stockholders' equity from December 31, 2024, to June 30, 2025, primarily driven by a reduction in cash and an increase in accumulated deficit | Metric | June 30, 2025 (in thousands) | Dec 31, 2024 (in thousands) | Change | | :-------------------------------- | :--------------------------- | :-------------------------- | :----- | | Cash | $4,766 | $9,860 | -51.7% | | Total current assets | $6,765 | $11,580 | -41.6% | | Total assets | $8,505 | $13,456 | -36.8% | | Total current liabilities | $1,831 | $2,428 | -24.5% | | Total liabilities | $3,172 | $3,933 | -19.4% | | Total stockholders' equity | $5,333 | $9,523 | -44.0% | | Accumulated deficit | $(337,774) | $(333,418) | +1.3% (increase in deficit) | Consolidated Statements of Operations The consolidated statements of operations detail the operating expenses, net loss, and earnings per share for the three and six-month periods, reflecting the reduced R&D and G&A expenses and the resulting lower net losses compared to the prior year | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | H1 2025 (in thousands) | H1 2024 (in thousands) | | :------------------------------------ | :--------------------- | :--------------------- | :--------------------- | :--------------------- | | Research and development | $1,122 | $4,308 | $2,482 | $7,258 | | General and administrative | $986 | $1,140 | $1,967 | $2,348 | | Total operating expenses | $2,108 | $5,448 | $4,449 | $9,606 | | Net loss | $(2,055) | $(5,343) | $(4,356) | $(9,299) | | Net loss per common share | $(0.20) | $(0.53) | $(0.43) | $(0.91) | Corporate Information This section provides an overview of Cocrystal Pharma, including its mission, a cautionary note on forward-looking statements, and investor contact details About Cocrystal Pharma, Inc. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company dedicated to discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses, and hepatitis C viruses, leveraging unique structure-based technologies and Nobel Prize-winning expertise - Cocrystal Pharma is a clinical-stage biotechnology company[18] - The company focuses on discovering and developing novel antiviral therapeutics for influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses, and hepatitis C viruses[18] - Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create viable antiviral drugs[18] Cautionary Note Regarding Forward-Looking Statements This section provides a standard cautionary note regarding forward-looking statements, emphasizing the inherent risks and uncertainties associated with drug development, regulatory approvals, financial needs, and external economic factors that could cause actual results to differ materially from projections - Forward-looking statements are based on current expectations and projections, and actual events may not occur due to various risks and uncertainties[19] - Important factors that could cause actual results to differ include the need for additional capital, inflation, recession, geopolitical conflicts, manufacturing and research delays, study progress and results, regulatory approvals, viral mutations, competitor treatments, and the company's ability to meet future liquidity needs[19] - The company undertakes no obligation to publicly update any forward-looking statement, except as may be required by law[19] Investor Relations This section provides contact information for investor relations inquiries - Investor Contact: Jody Cain, Alliance Advisors IR[20] - Contact Phone: 310-691-7100[20] - Contact Email: jcain@allianceadvisors.com[20]