Cocrystal Pharma Q1 2024 Financial Results and Antiviral Drug Updates

Cocrystal Pharma, Inc., a clinical-stage biotech company, released its financial results for the first quarter ending March 31, 2024, alongside updates on its antiviral product pipeline and forthcoming milestones. Cocrystal's dual focus on norovirus-coronavirus and influenza programs is expected to bring significant developments within this year, as stated by President and co-CEO, Sam Lee, Ph.D.

Key advancements include the anticipated topline results from the single ascending dose (SAD) phase of the first-in-human study involving CDI-988, a pan-coronavirus and pan-norovirus oral protease inhibitor, expected in Q2 2024. The multiple ascending dose (MAD) phase is scheduled to commence in the latter half of 2024. Further, the Phase 2a human challenge study with the novel oral PB2 inhibitor CC-42344 for influenza A is on track, with topline results anticipated in the second half of 2024. Preparations for an IND application to conduct a late-stage clinical study in the U.S. are also underway. Additionally, a Phase 1 study for inhaled CC-42344, aimed at being a potential prophylactic and therapeutic for influenza A, is planned for the latter half of the year.

The company continues to employ a cost-efficient business model to advance its development programs, with CFO and co-CEO, James Martin, highlighting the financial strategy that ensures sufficient funding for operations beyond the next twelve months.

Cocrystal’s antiviral product pipeline leverages its proprietary structure-based drug discovery platform technology. This approach targets highly conserved viral enzyme regions, aiming to develop broad-spectrum antivirals with high efficacy against viruses and their mutations, while minimizing off-target side effects.

Influenza Programs

Influenza remains a significant global health threat, with approximately 1 billion cases annually and up to 650,000 deaths worldwide, according to the World Health Organization. Cocrystal's CC-42344, an oral PB2 inhibitor, has shown potent antiviral activity against both pandemic and seasonal strains of influenza A, including those resistant to Tamiflu® and Xofluza®. The company initiated a Phase 1 study in March 2022, and by December 2022, reported favorable safety and tolerability results. Enrollment for the Phase 2a human challenge study was completed in May 2024, with results expected by the end of the year.

For inhaled CC-42344, which shows promising preclinical pulmonary exposure, a GLP toxicology study is ongoing, with a Phase 1 study in Australia slated for the latter half of 2024.

COVID-19 and Other Coronavirus Programs

Cocrystal aims to develop treatments for various coronavirus-induced diseases, including COVID-19, SARS, and MERS, by targeting viral replication enzymes and protease. The broad-spectrum protease inhibitor CDI-988 has demonstrated strong in vitro potency against SARS-CoV-2 and noroviruses. Following approval from Australian regulatory authorities, the Phase 1 study for CDI-988 began in September 2023. Topline results from the SAD cohort of this study are expected in Q2 2024.

Norovirus Program

Norovirus, the leading cause of acute gastroenteritis, affects millions globally each year. CDI-988 has shown broad activity against multiple norovirus strains, including the prevalent GII.4 strain. A Phase 1 study in healthy volunteers commenced in September 2023, with SAD cohort topline results anticipated in the second quarter of 2024.

Financial Summary

For Q1 2024, Cocrystal reported R&D expenses of $3.0 million, a decrease from $3.9 million in Q1 2023, attributed to the progression of CC-42344 and CDI-988 into advanced clinical stages. General and administrative expenses remained stable at $1.2 million. The company earned $220,000 in interest income, and experienced a foreign exchange loss of $18,000. The net loss for Q1 2024 was $4.0 million, or $0.39 per share, compared to a net loss of $5.2 million, or $0.64 per share, in Q1 2023. Cash and cash equivalents totaled $21.8 million as of March 31, 2024, with net cash used in operating activities amounting to $4.5 million for the quarter. The company maintains a working capital of $22.1 million and 10.2 million common shares outstanding.

Cocrystal Pharma continues to advance its antiviral therapeutics pipeline, aiming to address significant viral threats through innovative drug discovery and development.

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