NASDAQ:COCP
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Business Update
Topline Results for Phase 2a Trial of CC-42344 in 2H24
Cocrystal Pharma, Inc. (NASDAQ:COCP) is currently evaluating CC-42344 in a Phase 2a clinical trial. This is a human challenge study in which subjects were infected with influenza A before being treated with CC-42344 or placebo. We anticipate topline results from the study in the second half of 2024.
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. The company is planning to submit an investigational new drug (IND) application that will include data from the ongoing Phase 2a trial in the second half of 2024 such that a Phase 2b trial can be conducted in the U.S.
In addition to oral CC-42344, later this year Cocrystal will be initiating a Phase 1 clinical trial of inhaled CC-42344, which is currently being evaluated in a GLP toxicology study. An inhaled version of the drug would offer direct targeting of infected respiratory epithelial cells, a higher drug accumulation in the pulmonary system, and the potential for a rapid clinical response. Multiple preclinical studies have shown that CC-42344 exhibits a favorable safety profile in human upper airway epithelium and shows robust antiviral activity against H1N1 infection in vitro. We anticipate the Phase 1 clinical trial of inhaled CC-42344 being initiated in 2025.
No Safety or Tolerability Issues for CDI-988 in SAD Cohorts
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. CDI-988 is being developed as a treatment for both noroviruses and coronaviruses.
The Phase 1, single center, randomized, double blind trial is evaluating the safety, tolerability, and pharmacokinetics (including a food-effect cohort) of orally administered CDI-988 compared to placebo in healthy adults. 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 justify moving the compound into the multiple-ascending dose (MAD) portion of the Phase 1 study and the company is currently manufacturing drug product for MAD cohorts. We anticipate subject enrollment beginning in the fourth quarter of 2024.
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 August 13, 2024, Cocrystal announced financial results for the second quarter of 2024. As expected, the company did not report any revenues in the second quarter of 2024. R&D expenses in the second quarter of 2024 were $4.3 million, compared to $2.8 million in the second quarter of 2023. The increase was primarily due to CC-42344 entering into a Phase 2a trial and CDI-988 entering into a Phase 1 trial. G&A expenses in the second quarter of 2024 were $1.1 million compared to $1.5 million in the second quarter of 2023. The decrease was primarily due to lower legal expenses.
As of June 30, 2024, Cocrystal had approximately $18.1 million in cash and cash equivalents. We estimate this is sufficient to fund operations for at least the next 12 months. As of August 14, 2024, Cocrystal had approximately 10.2 million shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of 10.7 million shares.
Conclusion
We’re looking forward to topline results for the Phase 2a trial of CC-42344 in the second half 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 initiate the MAD portion of the Phase 1 study of CDI-988 following the announcement of positive results in the SAD portion of the trial. With no changes to our model our valuation remains at $7 per share.
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