Cocrystal Pharma, Inc. (NASDAQ: COCP) is a clinical-stage biotechnology company focused on developing novel antiviral therapeutics to transform the treatment of serious and chronic viral diseases. The company employs unique structure-based technologies and Nobel Prize-winning expertise to create first-in-class and best-in-class antiviral drugs that are safe, effective, and convenient to administer.
Cocrystal Pharma is dedicated to addressing unmet medical needs by advancing its pipeline of antiviral drug candidates targeting influenza virus, coronavirus, norovirus, and hepatitis C virus (HCV). The company's research and development efforts are centered on viral replication inhibitors, leveraging its infrastructure and expertise in these areas.
Influenza Program
Cocrystal's lead influenza candidate, CC-42344, is a novel PB2 inhibitor that has demonstrated excellent antiviral activity against influenza A strains, including avian pandemic strains, Tamiflu® and baloxavir resistant strains, with a favorable pharmacokinetic and drug resistance profile. In December 2023, the company announced the initiation of a randomized, double-blind, placebo-controlled Phase 2a human challenge trial evaluating the safety, tolerability, viral and clinical measurements of influenza A infection in subjects dosed with oral CC-42344. Topline results from this trial are expected in 2024.
Coronavirus and Norovirus Programs
In October 2022, Cocrystal selected a novel, broad-spectrum antiviral drug candidate, CDI-988, for clinical development as an oral treatment for SARS-CoV-2 and other coronaviruses. CDI-988 targets a highly conserved region in the active site of the SARS-CoV-2 main protease required for viral replication and has demonstrated pan-coronavirus activity. Subsequent studies also showed that CDI-988 exhibits broad-spectrum antiviral activity against multiple pandemic norovirus proteases.
In May 2023, the company received approval from the Australian Human Research Ethics Committee to conduct a randomized, double-blind, placebo-controlled Phase 1 study of CDI-988 to assess its safety, tolerability, and pharmacokinetics. The first subjects were dosed in this Phase 1 trial in September 2023, and topline results are expected in 2024.
Hepatitis C Program
Cocrystal's hepatitis C program is focused on developing CC-31244, a potential best-in-class pan-genotypic inhibitor of the NS5B polymerase, as part of an all-oral, shortened duration combination therapy. The company has completed a Phase 2a study with CC-31244 and is seeking a partner for further clinical development.
Financials
For the three months ended March 31, 2024, Cocrystal reported a net loss of $3,956,000, compared to a net loss of $5,189,000 for the same period in 2023. The company's annual net income for the fiscal year 2023 was -$17,984,000, with no revenue reported. Operating cash flow for the fiscal year 2023 was -$14,666,000, and free cash flow was -$14,784,000.
As of March 31, 2024, Cocrystal had $21,842,000 in unrestricted cash, which the company believes is sufficient to maintain planned operations for more than the next 12 months. The company has been primarily funded through equity offerings and is exploring additional financing options, including potential partnerships, to support the continued development of its pipeline.
Liquidity
Cocrystal has not yet established an ongoing source of revenue sufficient to cover its operating costs. The company has never been profitable on an annual basis. As of March 31, 2024, the company had $21,842,000 in unrestricted cash, which it believes is sufficient to maintain planned operations for more than the next 12 months.
The company has been primarily funded through public and private equity offerings and is exploring additional financing options, including potential partnerships, to support the continued development of its pipeline. Cocrystal is also a party to an At-The-Market Offering Agreement, which provides the company with the ability to issue and sell up to $7,250,000 of its common stock over time and from time to time.
Risks and Challenges
Cocrystal faces several risks and challenges common to clinical-stage biotechnology companies, including the ability to successfully complete clinical trials, obtain regulatory approvals, and commercialize its product candidates. The company also faces the risk of potential competition from other antiviral therapies, including those developed by larger pharmaceutical companies.
Additionally, the company's operations and financial performance could be impacted by macroeconomic factors, such as inflation, interest rate increases, and the potential for a recession, as well as geopolitical events, such as the wars in Israel and Ukraine, which could affect the global economy and disrupt supply chains and research activities.
Outlook
Cocrystal is focused on advancing its pipeline of antiviral drug candidates through clinical development and regulatory approval. The company anticipates several key milestones in 2024, including:
- Reporting topline results from the Phase 2a human challenge study of CC-42344 for the treatment of influenza A in the second half of 2024.
- Reporting topline results from the Phase 1 study of CDI-988 for the treatment of coronavirus and norovirus in 2024.
- Potentially initiating a Phase 1 clinical trial for an inhaled formulation of CC-42344 for the prophylactic treatment of influenza A infections.
These upcoming data readouts and potential clinical advancements will be important catalysts for the company as it continues to develop novel antiviral therapies to address significant unmet medical needs.
Conclusion
Cocrystal Pharma is a clinical-stage biotechnology company with a promising pipeline of antiviral drug candidates targeting influenza, coronavirus, norovirus, and hepatitis C. The company's unique structure-based drug discovery platform and Nobel Prize-winning expertise have enabled the development of first-in-class and best-in-class antiviral compounds.
With several key milestones expected in 2024, including topline results from the Phase 2a trial of CC-42344 for influenza A and the Phase 1 trial of CDI-988 for coronavirus and norovirus, Cocrystal is well-positioned to continue advancing its mission of transforming the treatment of viral diseases. As the company navigates the challenges of the current macroeconomic environment and competitive landscape, its focus on innovation and its strong cash position provide a solid foundation for future growth and value creation.