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Business Update
Norovirus Challenge Study to Commence in 4Q25
Cocrystal Pharma, Inc. (NASDAQ:COCP) is developing CDI-988 as a prophylaxis and treatment for norovirus, coronavirus, and other viral infections. The company recently presented results from the Phase 1a single ascending dose (SAD) and multiple ascending dose (MAD) trial at the 2025 Military Health System Research Symposium. The data showed that all doses, ranging from 100 mg to 1200 mg, were well tolerated. The rate of treatment-emergent adverse events was actually lower among CDI-988 subjects compared to placebo subjects in both the SAD (28% vs. 40%) and MAD (53% vs. 92%) cohorts. Importantly, there were no severe treatment-emergent adverse events, no clinically relevant ECG changes, and no clinically significant pathology results.
The Phase 1 trial was conducted in Australia. Cocrystal has filed an IND with the U.S. FDA in order to proceed with clinical trials in the U.S. and we expect clearance of the IND in September 2025. The company is then planning to conduct a Phase 1b coronavirus challenge study in the fourth quarter of 2025 to produce proof-of-concept data for CDI-988 as a preventative and a treatment. Outcomes that will be monitored include PK, symptoms, and viral shedding. Results of the study will dictate what future trials the company will pursue.
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. Norovirus prevention and/or therapy is particularly relevant for the military, where a pathogen of that nature can result in significant operational risks. There are multiple military installations, for instance on navy vessels, where norovirus could spread rapidly and possibly hinder combat readiness. Due to this, work on CDI-988 may qualify for various military-sponsored grants or other funding mechanisms, however we are unaware of any specifics at this point.
CDI-988 was developed using Cocrystal’s proprietary drug discovery platform technology. It binds to a highly conserved region in the active site of noroviruses and coronaviruses 3CL viral proteases and exhibits pan-viral activity against pandemic norovirus and coronavirus strains.
Phase 2a Trial of CC-42344 Extended
In December 2024, Cocrystal announced that the Phase 2a clinical trial of its oral PB2 inhibitor, CC-42344, will be extended due to unexpectedly low infection rates among trial participants that were challenged with a H3N2 influenza strain. The Phase 2a trial initiated in December 2023 and completed enrollment in May 2024 with 78 total participants. It is a single center study being conducted in the U.K. designed to test the safety, tolerability, pharmacokinetics (PK), antiviral activity, and clinical measurements of CC-42344.
The results of the trial showed that CC-42344 had a favorable safety and tolerability profile as no participants had serious adverse events or discontinued the trial due to drug-related adverse events, however due to the low infectivity rate the virology results were not interpretable. The company will be working with the contract research organization to amend the trial protocol to help ensure that there is a higher infectivity rate during the rest of the study. We anticipate updates from the company on the trial as warranted.
Background on CC-42344
CC-42344 is a broad-spectrum inhibitor of pandemic and seasonal strains of influenza A. It targets subunit PB2, which along with PA and PB1 forms the RNA-dependent RNA polymerase. This enzyme is essential for viral replication in cells by replicating the viral RNA segments and transcribing their genes, which makes it an attractive target for therapeutic intervention. The following figure shows CC-42344 binding to the highly conserved active site of the PB2 protein in different influenza strains.
Binding to this conserved active site leads to broad-spectrum antiviral activity against multiple Influenza A strains, including both pandemic and seasonal strains. The following table shows the strains that CC-42344 is active against, which includes strains that are resistant to oseltamivir and baloxavir.
Financial Update
On August 14, 2025, Cocrystal announced financial results for the second quarter of 2025. As expected, the company did not report any revenues in the second quarter of 2025. R&D expenses in the second quarter of 2025 were $1.1 million, compared to $4.3 million in the second quarter of 2024. The decrease was primarily due to the timing of clinical trial costs. G&A expenses in the second quarter of 2025 were $1.0 million, compared to $1.1 million for the second quarter of 2024. The decrease was primarily due to a reduction in salaries and wages.
As of June 30, 2025, Cocrystal had approximately $4.8 million in cash and cash equivalents, which we estimate is enough to fund operations through the end of 2025. As of August 12, 2025, Cocrystal had approximately 10.3 million shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of 11.0 million shares.
Conclusion
Following the successful Phase 1 SAD and MAD studies of CDI-988, we look forward to the results from the norovirus challenge study, which if the study is able to initiate in the fourth quarter of 2025 we anticipate in the first quarter of 2026. Next steps for the program will be dependent on the results obtained from that study, thus it could serve as a large inflection point for the company. With no changes to our model our valuation remains at $8 per share.
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