Cocrystal Pharma, Inc. - COCP STOCK NEWS

Cocrystal Pharma (Nasdaq: COCP) announced the selection of two investigational oral antiviral candidates, CDI-988 and CDI-873, for the treatment of SARS-CoV-2, showing superior in vitro potency against the virus and its variants, including Omicron.

Both candidates are poised for first-in-human trials in 2022, leveraging Cocrystal's proprietary drug discovery platform. The company also plans to expedite the development of an inhalation candidate, CDI-45205. Positive preclinical results and FDA guidance for CDI-45205 support upcoming clinical study plans.

Cocrystal Pharma (Nasdaq: COCP) announced receiving FDA guidance for the development of CDI-45205, a novel SARS-CoV-2 protease inhibitor, as a potential COVID-19 treatment. The FDA's response, which followed a pre-IND briefing, provides insights necessary for advancing the clinical development, including plans for a Phase 1 study set to begin in 2022. Cocrystal aims to conduct formulation development and IND-enabling studies, emphasizing the compound's antiviral efficacy against various SARS-CoV-2 variants, including Omicron.

Cocrystal Pharma (Nasdaq: COCP) announced its participation in the H.C. Wainwright BioConnect Virtual Conference from January 10-13, 2022. A webcast of the presentation will be available on January 10, 2022, at 7:00 a.m. ET. The company aims to initiate first-in-human studies for two SARS-CoV-2 antivirals targeting COVID-19 and is progressing with its influenza A Phase 1 trial. Cocrystal is well positioned financially with a solid cash position and a debt-free balance sheet, allowing it to advance its clinical plans.

Cocrystal Pharma (Nasdaq: COCP) announced significant progress in combating COVID-19, confirming its protease inhibitors' efficacy against the Omicron variant and other strains. The company plans to initiate Phase 1 clinical studies for its intranasal and oral COVID-19 protease inhibitors, CDI-45205 and another yet-to-be-named oral inhibitor, shortly. Their inhibitors have exhibited broad-spectrum activity and promising safety profiles in preclinical studies, displaying no cytotoxicity and good bioavailability.

Cocrystal Pharma, Inc. (Nasdaq: COCP) announced that President and interim CEO Sam Lee and CFO James Martin will present a company overview during the Noble Capital Markets Virtual Roadshow on December 8, 2021. The presentation will discuss Cocrystal's progress towards initiating clinical studies in 2022 for two COVID-19 protease inhibitors, which have shown broad-spectrum activity against variants including Delta. The company awaits FDA feedback on its IND briefing for its intranasal COVID-19 inhibitor and plans to submit another for its oral inhibitor in early 2022.

Cocrystal Pharma (Nasdaq: COCP) unveiled its clinical plans for two antiviral compounds targeting COVID-19 at the World Antiviral Congress 2021. The company presented promising preclinical data on CDI-45205, an intranasal lead, and oral protease inhibitors. The Phase 1 and Phase 2 trials are expected to assess safety and efficacy, focusing on the treatment of mild to moderate COVID-19. Cocrystal's inhibitors demonstrated broad-spectrum antiviral activity against multiple SARS-CoV-2 variants. The company is awaiting FDA feedback on its pre-IND briefing package.

Cocrystal Pharma (Nasdaq: COCP) reported no revenues for Q3 2021, down from $489,000 a year ago. R&D expenses rose to $2.2 million, primarily due to advancements in COVID-19 and influenza programs. The net loss widened to $3.9 million, or $0.04 per share, compared to a loss of $2.7 million, or $0.05 per share, in Q3 2020. For the first nine months of 2021, the company reported no revenues versus $1.5 million in 2020, while R&D expenses increased 22% to $6.5 million. They have $61.6 million in cash and aim to advance multiple antiviral compounds into clinical development by 2022.

Cocrystal Pharma, Inc. (Nasdaq: COCP) announced that its SARS-CoV-2 main protease inhibitors exhibit strong in vitro activity against various common viruses, including rhinoviruses and noroviruses. These inhibitors were developed using proprietary drug discovery technology and are advancing towards clinical trials as potential COVID-19 treatments. President Sam Lee highlighted the significance of these drugs as potential oral therapies and expressed optimism for addressing other viral diseases.

Cocrystal Pharma (Nasdaq: COCP) has submitted a pre-Investigational New Drug briefing package to the FDA for its broad-spectrum protease inhibitor CDI-45205, aiming to treat COVID-19. The submission seeks FDA guidance on clinical trial design, including preclinical studies and toxicology assessments. CDI-45205 has demonstrated potent in vitro activity against multiple SARS-CoV-2 variants and is being developed for various administration routes, with a focus on intranasal delivery. Cocrystal believes its targeted approach may offer a superior treatment solution compared to repurposed drugs.