On January 8, 2024, Cocrystal Pharma (NASDAQ:COCP) released a new investor presentation which can be found here.
On January 4, 2024, Cocrystal Pharma provided an update on the clinical development of its oral first-in-class pan-norovirus and pan-coronavirus dual protease inhibitor CDI-988 and its oral PB2 inhibitor CC-42344 for the treatment of pandemic and seasonal influenza A. CDI-988 and CC-42344 were specifically designed and developed using the company’s unique structure-based drug discovery technology platform to be effective on a broad range of viruses causing these diseases.
Cocrystal’s President and co-CEO stated, “We are encouraged that the preliminary data of the ongoing Phase 2a and Phase 1 studies showed CC-42344 and CD-988 were well-tolerated with favorable safety profiles. We see great promise with both of these drug candidates as potential effective oral treatments for highly contagious, pandemic viruses, while also providing significant market opportunities for Cocrystal.”
CDI-988 targets a highly conserved region in the active site of the main 3CL protease required for viral RNA replication for pandemic norovirus and coronaviruses, including SARS-CoV-2. CDI-988 is being evaluated for safety and pharmacokinetics in a randomized, double-blinded, placebo-controlled Phase 1 study in healthy subjects being conducted in Australia. The company reports favorable preliminary data from the single-ascending dose cohorts of the clinical study. Cocrystal expects to report topline results from the Phase 1 study in 2024.
CC-42344 binds to a highly conserved PB2 site of the influenza A polymerase complex and exhibits a novel mechanism of action that inhibits viral replication. A randomized, double-blind, placebo-controlled Phase 2a clinical study with CC-42344 is underway in the United Kingdom. The company reports favorable tolerability and safety in the first cohort of the Phase 2a influenza A challenge study and expects to report topline results from the Phase 2a clinical study in 2024. In 2022 Cocrystal reported favorable safety and tolerability results in the healthy volunteer Phase 1 study with CC-42344 conducted in Australia.
On December 15, 2023, the company received written notice from Merck that they were electing to terminate the Exclusive License and Research Collaboration Agreement between Cocrystal and Merck concerning the collaboration on the development of influenza A/B antiviral compounds.
The termination of the Agreement is effective on March 14, 2024. According to the termination notice, Merck determined there were no existing conditions to continue the collaboration. The termination resulted from the inability to develop the compounds to meet a specific aspect of Merck’s program.
Under the terms of the Agreement, Merck funded research and development of influenza A/B antiviral agents at the company and Merck, including clinical development at Merck, protecting intellectual property, and Merck was responsible for worldwide commercialization of any products derived from the collaboration.
Cocrystal received an upfront payment of $4,000,000 in January 2019 and was eligible to receive milestone payments related to designated development, regulatory and sales milestones, as well as royalties on product sales. In January 2021, the company announced it had completed all research obligations under the Agreement, and that Merck was then solely responsible for further development of the influenza A/B antiviral compounds that were discovered in the collaboration. The pending patent applications on compounds covered by the Agreement and previously filed by Merck on behalf of both companies remain in place.
On December 6, 2023, the company announced the achievement of first-patient-in for the Phase 2a human challenge clinical trial with CC-42344, an investigational new oral antiviral inhibitor for the treatment of pandemic and seasonal influenza A. This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, viral and clinical measurements of influenza A infection in subjects dosed with oral CC-42344 treatment.
Cocrystal’s President and co-CEO Sam Lee stated, “There is an urgent need for new oral antivirals targeting pandemic and seasonal influenza that address drug resistance. CC-42344 was discovered using our proprietary structure-based drug discovery platform technology to inhibit the viral replication process. The data from this proof-of-concept clinical study will further validate CC-42344’s novel mechanism of action. We expect to report topline data from this clinical trial in 2024.”
In late 2022 Cocrystal reported favorable safety and tolerability results in the single-ascending and multiple-ascending dose portions of the healthy volunteer Phase 1 trial conducted in Australia. Preclinical data showed that CC-42344 is highly active against seasonal and pandemic influenza A strains. In October 2023 Cocrystal received authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency to initiate a Phase 2a human challenge trial with CC-42344 as a potential treatment for pandemic and seasonal influenza A.
Valuation & Estimate Changes
The company’s cash position of $29.7 million at the end of the 3rd quarter of 2023 should be sufficient to fund its operations through the next 12 months depending on R&D spending levels.
We adjust our 2024 and 2025 revenue and EPS estimates to account for the absence of any Merck milestone payments. Our 2024 estimates now call for zero revenues during the year and a loss per share of ($2.05).
We lower our price target to $4.00 per share based on the recent updates.
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