Cocrystal Pharma Q2 2024 Financial Results and Antiviral Drug Program Updates

Cocrystal Pharma, Inc., a clinical-stage biotechnology firm located in Bothell, Washington, has reported its financial results for the second quarter and half-year ending June 30, 2024. The company is focusing on its antiviral product pipeline, targeting viruses like influenza, coronaviruses, and noroviruses.

Clinical Program Advancements

Cocrystal's President and co-CEO, Dr. Sam Lee, highlighted significant upcoming milestones. The company anticipates releasing topline results in 2025 from its Phase 2a study involving the PB2 inhibitor CC-42344, which aims to treat influenza A. This includes initial indications of its impact on virology. Furthermore, Cocrystal is poised to file an Investigational New Drug (IND) application in 2025 for subsequent studies in the U.S.

The efficacy of CC-42344 has been further validated through in vitro testing, demonstrating its ability to inhibit a new, highly pathogenic avian flu PB2 protein recently found in U.S. dairy cows. Additionally, preparations are underway for a Phase 1 study, which will evaluate CC-42344 as a potential prophylactic and therapeutic agent for influenza A in healthy volunteers.

Regarding the pan-norovirus/pan-coronavirus oral protease inhibitor CDI-988, Cocrystal plans to commence a Phase 1 study in 2025. Following promising safety and tolerability data from the single-ascending dose (SAD) portion of the study, Dr. Lee mentioned that they expect to report full study results by late 2024 or early 2025.

Antiviral Product Pipeline

Cocrystal employs a proprietary structure-based drug discovery platform to develop broad-spectrum antivirals aimed at inhibiting viral replication. This approach targets highly conserved regions of viral enzymes to create drugs effective against both the virus and its mutations, reducing the likelihood of undesirable side effects.

Influenza Programs

Influenza remains a significant global health concern, with annual cases reaching approximately 1 billion, leading to severe illnesses and substantial fatalities. Cocrystal's novel PB2 inhibitor CC-42344 has exhibited excellent in vitro antiviral activity against both pandemic and seasonal influenza A strains, including those resistant to existing treatments like Tamiflu® and Xofluza®.

The company has made significant strides in studying CC-42344. Initial Phase 1 trials indicated favorable pharmacokinetics (PK) and safety profiles. Subsequent authorization from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) enabled a Phase 2a human challenge study to evaluate its efficacy in influenza A-infected subjects. Feedback from the FDA in March 2024 has provided clarity on the study's design, drug manufacturing, and necessary nonclinical studies. Cocrystal completed enrollment in this Phase 2a study in May 2024 and has since reported that CC-42344 inhibits the avian influenza A (H5N1) PB2 protein.

Norovirus Program

Norovirus is a highly contagious virus that causes acute gastroenteritis, responsible for significant morbidity and mortality worldwide. Cocrystal is developing CDI-988, an oral broad-spectrum protease inhibitor, to target norovirus and coronavirus infections. CDI-988 has shown pan-viral activity against multiple norovirus strains. A Phase 1 study for CDI-988 has been approved in Australia, and dosing of subjects commenced in September 2023. The company plans to report topline results from this study by late 2024 or early 2025.

Financial Overview

For the second quarter of 2024, Cocrystal's research and development (R&D) expenses rose to $4.3 million from $2.8 million in the same period of 2023, primarily due to the progression of CC-42344 and CDI-988 clinical studies. General and administrative (G&A) expenses decreased to $1.1 million from $1.5 million, mainly due to reduced legal expenses. Consequently, the net loss for Q2 2024 was $5.3 million, compared to $4.2 million in Q2 2023.

For the first half of 2024, R&D expenses increased to $7.3 million, while G&A expenses decreased to $2.3 million. The net loss for this period was $9.3 million, slightly down from $9.4 million in the first half of 2023.

As of June 30, 2024, Cocrystal reported unrestricted cash of $18.1 million, a decrease from $26.4 million as of December 31, 2023. The company used $8.2 million in operating activities during the first half of the year, compared to $8.7 million in the same period of 2023, leaving them with a working capital of $17.0 million and 10.2 million common shares outstanding.

Cocrystal continues to leverage its unique structure-based technologies to develop first- and best-in-class antiviral drugs, aiming to provide effective treatments for a range of viral infections.

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