Cocrystal Pharma Reports First Quarter 2025 Financial Results and Provides Updates on its Antiviral Drug-Development Programs
- CDI-988 demonstrated superior broad-spectrum antiviral activity against major norovirus variants
- Reduced net loss to $2.3M in Q1 2025 from $4.0M in Q1 2024
- Decreased R&D expenses by 53% to $1.4M from $3.0M year-over-year
- Favorable safety and tolerability results from CDI-988 Phase 1 study
- Cash position decreased to $6.9M from $9.9M in previous quarter
- Delays in CC-42344 Phase 2a human challenge study due to low infection rates
- Net cash burn of $2.9M in Q1 2025
Insights
Cocrystal's financial position weakens while lead antiviral candidates show promising progress toward upcoming clinical milestones.
Cocrystal's Q1 report reveals a significant cash runway concern with cash reserves dropping to
The company has strategically reduced R&D expenses by
Despite financial constraints, Cocrystal's pipeline shows promise. The norovirus candidate CDI-988 demonstrated superior broad-spectrum activity against major variants including the currently circulating GII.17 and GII.4 strains. The company expects to report topline Phase 1 results for the high-dose cohort in Q2 2025 and plans to initiate a human challenge study for both treatment and prophylaxis in the coming months.
The influenza program hit a setback with the CC-42344 Phase 2a study being extended due to unexpectedly low infection rates among participants, though the company's quick pivot to inhaled formulation development shows adaptability. The company's platform technology targeting conserved viral regions positions its candidates to potentially maintain efficacy against mutations - a significant advantage in antiviral development if proven successful in clinical trials.
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 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
- 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 Program
Norovirus 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
- 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 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
- 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
Net loss for the first quarter of 2025 was
Cocrystal reported unrestricted cash as of March 31, 2025 of
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 IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com
Financial Tables to follow
COCRYSTAL PHARMA, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands)
| March 31, 2025 | December 31, 2024 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | 6,921 | $ | 9,860 | ||||
| Restricted cash | 75 | 75 | ||||||
| Tax credit receivable | 1,445 | 1,215 | ||||||
| Prepaid expenses and other current assets | 385 | 430 | ||||||
| Total current assets | 8,826 | 11,580 | ||||||
| Property and equipment, net | 127 | 153 | ||||||
| Deposits | 86 | 29 | ||||||
| Operating lease right-of-use assets, net (including | 1,620 | 1,694 | ||||||
| Total assets | $ | 10,659 | $ | 13,456 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 1,622 | $ | 2,127 | ||||
| Current maturities of operating lease liabilities (including | 309 | 301 | ||||||
| Total current liabilities | 1,931 | 2,428 | ||||||
| Long-term liabilities: | ||||||||
| Operating lease liabilities (including | 1,424 | 1,505 | ||||||
| Total long-term liabilities | 1,424 | 1,505 | ||||||
| Total liabilities | 3,355 | 3,933 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock, | 10 | 10 | ||||||
| Additional paid-in capital | 343,013 | 342,931 | ||||||
| Accumulated deficit | (335,719 | ) | (333,418 | ) | ||||
| Total stockholders’ equity | 7,304 | 9,523 | ||||||
| Total liabilities and stockholders’ equity | $ | 10,659 | $ | 13,456 | ||||
COCRYSTAL PHARMA, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share data)
| Three months ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Operating expenses: | ||||||||
| Research and development | 1,360 | 2,950 | ||||||
| General and administrative | 981 | 1,208 | ||||||
| Total operating expenses | 2,341 | 4,158 | ||||||
| Loss from operations | (2,341 | ) | (4,158 | ) | ||||
| Other income (expense): | ||||||||
| Interest income (expense), net | 37 | 220 | ||||||
| Foreign exchange gain (loss), net | 3 | (18 | ) | |||||
| Total other income (expense), net | 40 | 202 | ||||||
| Net loss | $ | (2,301 | ) | $ | (3,956 | ) | ||
| Net loss per common share, basic and diluted | $ | (0.23 | ) | $ | (0.39 | ) | ||
| Weighted average number of common shares, basic and diluted | 10,174 | 10,174 | ||||||
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