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Cocrystal Pharma (NASDAQ:COCP) reported 2022 1st quarter results on May 11, 2022. For the quarter, the company reported no revenues compared to our expectations that it was possible that some milestone payments from the Merck collaboration might occur during the quarter.
General & Administrative expenses were $1.33 million which was below our expectations due to lower-than-expected professional fees. Research & Development expenses came in at $2.87 million for the quarter, an increase of 82.0% from the prior year as the company ramped up spending for their Covid-19 and influenza programs. As the company pushes forward on clinical trials for its Covid-19 and Influenza A programs, we expect R&D to increase throughout the year on sequential basis.
Net loss for the quarter was $4.2 million, or ($0.04) per diluted share, which was in line with our expectations. Net cash used in operating activities was $3.9 million and the company reported no capital expenditures during the period. There were no capital raises during the quarter from either the equity markets or debt financing.
The company's unrestricted cash balance at quarter end was $54.8 million and total liabilities were only $1.79 million, none of which was considered traditional debt.
Cocrystal also reported updates on its current pipeline products.
Pandemic and Seasonal Influenza A – In March 2022, Cocrystal initiated enrollment in a Phase 1 study with orally administrated antiviral CC-42344 in healthy adults. This randomized, double-controlled, dose-escalating study is designed to assess the safety, tolerability and pharmacokinetics of CC-42344.
Also in March, the company announced dosing of the first subjects in the Phase 1 clinical trial with CC-42344 that is taking place in Australia. A novel PB2 inhibitor, CC-42344 has shown excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as strains resistant to Tamiflu and Xofluza. CC-42344 also has favorable pharmacokinetic and drug-resistance profiles.
In April 2022, the company announced preliminary data from its Phase 1 study with CC-42344, which demonstrated a favorable safety and pharmacokinetic profile in the first two cohorts administered single-ascending doses of 100 mg and 200 mg. The company expects to complete this Phase 1 clinical study and report relevant data in 2022.
Intranasal/Pulmonary Protease Inhibitor CDI-45205 – This is the company's novel SARS-CoV-2 3CL (main) protease inhibitor being developed as a potential treatment for COVID-19 and its variants via intranasal/pulmonary delivery. The company has initiated scale-up synthesis and process chemistry development with CDI-45205 in order to assemble data to support an IND application with the goal of progressing to a first-in-human clinical trial in 2022.
In January 2022, Cocrystal received guidance from the FDA regarding further preclinical and clinical development of CDI-45205 that provides them with a clearer pathway for the Phase 1 study that is expected to commence at some point in 2022, as well as directives for designing a subsequent Phase 2 study.
CDI-45205 demonstrated good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and no cytotoxicity against a variety of human cell lines. CDI-45205 also demonstrated a strong synergistic effect with the FDA-approved COVID-19 medicine remdesivir.
CDI-45205 was among the broad-spectrum viral protease inhibitors obtained from Kansas State University Research Foundation (KSURF) under an exclusive license agreement announced in 2020. The company still believes the protease inhibitors obtained from KSURF have the ability to inhibit the inactive SARS-CoV-2 polymerase replication enzymes into an active form.
Oral Protease Inhibitors CDI-988 and CDI-873 – In January 2022, the company chose investigational novel antiviral drug candidates CDI-988 and CDI-873 for further development as potential oral treatments for COVID-19. Both candidates were designed and developed using their proprietary structure-based drug discovery platform technology. These agents are chemically differentiated and exhibit superior in vitro potency again SARS-CoV-2, with activity maintained against current variants of concern. Both candidates demonstrated a favorable safety profile and pharmacokinetic properties that are supportive of daily oral dosing.
Cocrystal plans to initiate a Phase 1 trial as soon as possible in 2022 with one of these candidates. The company believes the FDA's guidance for further development of CDI-45205 provides them with a clearer pathway for the clinical development of this oral COVID-19 program.
Pandemic and Seasonal Influenza A/B program - In January 2019, Cocrystal entered into an Exclusive License and Research Collaboration Agreement with Merck to discover and develop certain proprietary influenza antiviral agents that are effective against both influenza A and B strains. This agreement includes milestone payments of up to $156 million plus royalties on sales of products discovered under the agreement.
In January 2021, the company announced they had completed all of their research obligations under the agreement. Merck is now solely responsible for further preclinical and clinical development of the influenza A/B antiviral compounds discovered under this agreement. Merck continues developmental activities with the antiviral influenza A/B compounds the company discovered under this agreement.
Other – There was no material new information with regards to the company's Norovirus and Hepatitis C programs. The company is still looking for a partner to advance the development of the Hepatitis C program (CC-31244).
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