By David Bautz, PhD

NASDAQ:COCP

READ THE FULL COCP RESEARCH REPORT

Business Update

Multiple Upcoming Catalysts

Cocrystal Pharma, Inc. (NASDAQ:COCP) has multiple upcoming catalysts over the next few months as it develops CC-42344 as a treatment for influenza and CDI-988 as a treatment for both coronavirus and norovirus infections.

• Before the end of 2024, we expect Cocrystal to report topline results from the Phase 2a clinical trial of CC-42344. It is a human challenge study being conducted in the U.K. in which subjects are infected with influenza A before being treated with CC-42344 or placebo.

• We anticipate the company filing an Investigational New Drug (IND) application in 2025 in order to conduct a late-stage study of CC-42344 in the U.S. In the first quarter of 2024, Cocrystal received feedback from the FDA regarding the regulatory requirements for a planned Phase 2b trial with CC-42344.

• In late 2024 or early 2025, we anticipate the company reporting topline and tolerability results from the multiple-ascending dose (MAD) cohorts of the Phase 1 clinical trial of CDI-988, the company’s broad-spectrum antiviral inhibitor of 3CL viral proteases. CDI-988 is being developed as a treatment for both noroviruses and coronaviruses.

In July 2024, Cocrystal reported favorable safety and tolerability results from the single-ascending dose (SAD) cohorts of the Phase 1 trial of CDI-988, the company’s broad-spectrum antiviral inhibitor of 3CL viral proteases. Doses of CDI-988 from 100 mg to 600 mg were evaluated in the SAD cohorts. The results of the study showed that all participants completed the trial with no discontinuations. In addition, there were no serious adverse events or severe treatment-emergent adverse events reported. Lastly, no clinically significant observations were seen in laboratory assessments, physical exams, or electrocardiograms. These results justified moving the compound into the MAD portion of the Phase 1 study.

There are no approved therapies for norovirus infection, which is the most common cause of acute gastroenteritis. According to the Centers for Disease Control (CDC), there are an estimated 685 million cases and 200,000 deaths caused by norovirus infection each year worldwide. In the U.S., norovirus infection causes over 2 million outpatient clinical visits annually and approximately 100,000 hospitalizations. In addition to potentially being utilized as a norovirus therapy, CDI-988 may be tested as a prophylactic to be used in population dense areas to prevent norovirus outbreaks (e.g., cruise ships, nursing homes, day cares, military installations).

Financial Update

On November 13, 2024, Cocrystal announced financial results for the third quarter of 2024. As expected, the company did not report any revenues in the third quarter of 2024. R&D expenses in the third quarter of 2024 were $3.2 million, compared to $4.2 million in the third quarter of 2023. The decrease was primarily due to lower clinical trial expenses. G&A expenses in the third quarters of both 2024 and 2023 were $1.8 million.

As of September 30, 2024, Cocrystal had approximately $13.0 million in cash and cash equivalents. We estimate this is sufficient to fund operations for at least the next 12 months. As of November 13, 2024, Cocrystal had approximately 10.2 million shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of 11.0 million shares.

Conclusion

We’re looking forward to topline results for the Phase 2a trial of CC-42344 before the end of 2024. These results may also include initial anti-viral efficacy as subjects in the trial were infected with influenza A virus. The company is on track to report topline results from the MAD portion of the Phase 1 study of CDI-988 in late 2024 or early 2025. As we await results from the Phase 2a trial of CC-42344, our valuation remains at $7 per share. 

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