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Business Update
Phase 1b Challenge Study of CDI-922 to be Initiated in 1H26
Cocrystal Pharma, Inc. (NASDAQ:COCP) is developing CDI-988 as a prophylaxis and treatment for norovirus, coronavirus, and other viral infections. The company previously presented results from the Phase 1a single ascending dose (SAD) and multiple ascending dose (MAD) trial at the 9th International Calicivirus Conference. The study enrolled 46 (N=36 drug; N=10 placebo) individuals into the single ascending dose (SAD) cohort and 48 (N=36 drug; N=12 placebo) individuals into the multiple ascending dose (MAD) cohort. The SAD results showed that all doses (100 mg to 1200 mg) were well tolerated, there were no reports of serious adverse events, no clinically relevant ECG changes, no clinically significant pathology results, and no discontinuations from the study or use of the study drug. Similar results were seen in the MAD cohort, as all doses (200 mg to 1200 mg) were well tolerated, there were no reports of serious adverse events, no clinically relevant ECG changes, and no clinically significant pathology results. There was one discontinuation from the study and study drug due to Grade 2 diarrhea for an individual in the 1200 mg BID Fed group. This discontinuation was deemed probably related to the study drug. CDI-988 shows a strong food effect (5-fold higher plasma exposure when administered after a high-fat meal), thus, that may have contributed to the Grade 2 diarrhea for that individual.
The topline safety data are summarized in the table below. Headache was the most frequently reported treatment emergent adverse event (TEAE), and overall, the placebo groups had a higher frequency of TEAEs than the CDI-988 groups.
The presentation also noted that there has been a rapid surge of norovirus outbreaks in the past year following the COVID-19 pandemic. This has been accompanied by a transition from strain GII.4 being the dominant strain to GII.17. Thus, in order to create an effective broad-spectrum norovirus therapy, it is necessary to have activity against multiple strains of the virus. CDI-988 shows broad-spectrum binding against multiple norovirus strains, as shown in the following results for in vitro potency assays.
The Phase 1 trial was conducted in Australia. Cocrystal filed an IND with the U.S. FDA in order to proceed with clinical trials in the U.S. and received clearance of the IND in September 2025. The company is currently planning to initiate a Phase 1b coronavirus challenge study in the first quarter of 2026 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.
SBIR Award to Develop Influenza A/B Treatment
In October 2025, Cocrystal announced it was awarded a Small Business Innovation Research (SBIR) Phase I award from the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID). The $500,000 award (number 75N93025C00038) will be utilized to advance the company’s development of a novel, oral, broad-spectrum antiviral candidate to treat influenza A and B infections. Those non-dilutive funds specifically will be utilized to characterize lead candidate molecules that inhibit the target of the essential function of the influenza polymerase complex.
Financial Update
On November 14, 2025, Cocrystal announced financial results for the third quarter of 2025. As expected, the company did not report any revenues in the third quarter of 2025. R&D expenses in the third quarter of 2025 were $1.0 million, compared to $3.2 million in the third quarter of 2024. The decrease was primarily due to the Phase 2a trial of CC-42344 and the Phase 1 clinical trial of CDI-988 in 2024. G&A expenses in the third quarter of 2025 were $1.1 million, compared to $1.8 million for the third quarter of 2024. The decrease was primarily due to a reduction in compensation expense.
As of September 30, 2025, Cocrystal had approximately $7.7 million in cash and cash equivalents, which includes the $4.7 million in gross proceeds from a registered direct offering completed in September 2025 but does not include the gross proceeds of $1.03 million from a private placement in October 2025. As of November 14, 2025, Cocrystal had approximately 13.8 million shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of 20.3 million shares.
Conclusion
Now that the company has received clearance from the FDA to proceed, we look forward to the initiation and the topline data readout for the Phase 1b trial of CDI-988 in norovirus prophylaxis and treatment. The SBIR award is a nice infusion of non-dilutive cash for the company’s balance sheet while helping to advance its influenza A/B program. With the company’s emphasis on pursuing government and military funding we are hopeful this will be the first of many such non-dilutive grants. With no changes to our model our valuation remains at $8 per share.
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