Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Potential Efficacy Against A New Strain Of Avian Influenza. Cocrystal has announced that studies of its influenza drug, CC-42344, have shown efficacy against the new avian influenza strain H5N1. Cocrystal has used its proprietary technology to determine the strain’s mutations and structure, then conduct preliminary tests. The binding site for CC-42344 was not changed and can block reproduction of the new strain, making it an effective vaccine against the virus.
Avian Influenza Strain Has Begun To Infect Humans. Avian influenza H5N1 has caused significant illness in commercial bird flocks since 2003. Its impact was limited until recent outbreaks in dairy cattle and infections in diary workers. This ability to mutate and infect other species is a significant step toward causing widespread outbreaks in humans, elevating it to a public health concern.
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BOTHELL, Wash., June 20, 2024 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc.’s (Nasdaq: COCP) novel, broad-spectrum antiviral CC-42344 inhibits activity in the highly pathogenic avian influenza A (H5N1) PB2 protein recently identified in infected dairy cattle, according to recently completed in vitro studies. CC-42344 is a new class of antiviral drugs designed to block essential steps in the replication and transcription of the influenza A virus.
Cocrystal demonstrated the potential efficacy of CC-42344 against the new avian flu strain with the recently published genome sequence for H5N1. Using its proprietary structure-based platform, Cocrystal created a high-resolution crystal structure of this avian PB2 protein and confirmed that CC-42344 binds to its highly conserved PB2 region. The in vitro data were generated testing CC-42344 against the avian H5N1 PB2 protein and further support CC-42344’s activity similar to that of Cocrystal’s data with pandemic and seasonal influenza A.
CC-42344 binds to the highly conserved region of the avian influenza A H5N1 PB2 protein
“The findings validate our broad-spectrum approach to the treatment and prevention of pandemic flu. This is important as there are no specific FDA-approved vaccines to prevent infections by this virus in humans,” said Sam Lee, PhD, President and co-CEO of Cocrystal. “These findings support our previously reported preclinical data showing that CC-42344 is highly active against seasonal and pandemic influenza A strains, including emerging mutations. CC-42344 is an inhibitor compound providing a unique mechanism of action with a high barrier to resistance.”
“Recent CDC reported avian flu outbreaks in the U.S., which include the first cases of humans exposed to infected dairy cows, are concerning,” said James Martin, CFO and co-CEO of Cocrystal. “The CDC reported three additional cases of avian influenza infection from exposure to dairy cows in early June and avian flu is now confirmed in more than 100 dairy herds in 12 U.S. states.”
About Avian Influenza A H5N1 Avian influenza A H5N1 was reported in 889 cases and caused 463 deaths in 23 countries between 2003 and April 2024, according to the World Health Organization (WHO). On April 1, 2024, the CDC reported a case of highly pathogenic avian influenza A H5N1 in a farmworker in Texas during a multistate outbreak of avian influenza in dairy cows. Two more cases were subsequently reported in farmworkers in Michigan.
The CDC analyzed sera (blood) collected from people of all ages in all 10 Health & Human Services regions during the 2022-2023 and 2021-2022 flu seasons. These samples were challenged with H5N1 virus to see whether there was an antibody reaction. Data from this study suggest that there is extremely low to no population immunity to clade 2.3.4.4b A (H5N1) viruses in the U.S. Antibody levels remained low regardless of whether or not the participants received a seasonal flu vaccination, meaning that seasonal flu vaccination did not produce antibodies to H5N1 viruses.
Cocrystal Pharma determined the high resolution X-ray crystal structure of the recent avian influenza A (H5N1) PB2 protein and confirmed activity of CC-42344 in vitro (NIH GeneBank ID:influenza A/Texas/37/2024(H5N1). The crystal structure of the avian influenza A (H5N1) PB2 protein showed new mutations located outside the PB2 active site. Subsequent studies showed that CC-42344 binds to the active site of the avian influenza A (H5N1) PB2 protein as previously demonstrated with the pandemic and seasonal influenza A PB2. Preliminary in vitro assays confirmed that CC-42344 exhibits high potency against the avian influenza A (H5N1) PB2 protein.
About CC-42344 CC-42344 is Cocrystal’s novel, broad-spectrum, antiviral investigational candidate for the treatment of pandemic and seasonal influenza A. CC-42344 inhibits the first step in influenza A’s viral replication by binding to a highly conserved PB2 site of the influenza polymerase complex that is essential to replication and was discovered using Cocrystal’s proprietary structure-based drug discovery platform technology.
Cocrystal is conducting a Phase 2a human challenge study in the United Kingdom to evaluate safety, viral and clinical measures of oral CC-42344 in healthy volunteers who are challenged with influenza A. CC-42344 was advanced into Phase 2a testing following favorable safety and tolerability results reported in a Phase 1 study in healthy volunteers conducted in Australia. In vitro testing showed CC-42344’s excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant to Tamiflu® and Xofluza®, while also demonstrating favorable pharmacokinetic and safety profiles.
About Cocrystal Pharma, Inc. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential efficacy of CC-42344 against the avian influenza A H5N1 virus, the expected timing and results of the Phase 2a trial for CC-42344 for the oral treatment of influenza A in 2024, and the potential market for such product candidate. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, risks relating to our ability to obtain regulatory authority for and proceed with clinical trials including recruiting volunteers and procuring materials for such studies by our clinical research organizations and vendors, the results of such studies, our and our collaboration partners’ technology and software performing as expected, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes, and potential development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2023. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Clinical Milestones Are On Schedule. Cocrystal reported 1Q loss of $4.0 million or $(0.39) per share. During the quarter, the company made progress on its clinical trials and reiterated upcoming milestones for its Phase 1 trial testing CDI-988 in norovirus and COVID-19 and its Phase 2a trial testing CC-42344 in influenza. Cash on March 31, 2024, was $21.8 million.
Results Expected Shortly From The CC-42344 Influenza Virus Program. CC-42344 is an oral PB2 inhibitor in development against a broad spectrum of pandemic and seasonal influenza stains. Enrollment for the current Phase 2a human-challenge study was completed in May 2024. This trial is being conducted in the UK, with data expected to be reported in 2H24. The company has received FDA guidance on the IND filing requirements for Phase 2b trials. The IND filing is expected in 2H24.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
BOTHELL, Wash., May 01, 2024 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces completion of enrollment of 78 subjects who were infected with influenza A in a randomized, double-blind, placebo-controlled Phase 2a human challenge clinical study evaluating the safety, tolerability, antiviral and clinical measurements of its novel, broad-spectrum, oral PB2 inhibitor CC-42344. CC-42344 is a new class of antiviral treatment designed to effectively block an essential step in the viral replication and transcription of pandemic and seasonal influenza A, and was discovered using the Company’s proprietary structure-based drug discovery platform technology.
“There is an urgent need for new influenza antivirals targeting highly pathogenic avian pandemic and seasonal influenza strains. It’s gratifying to report the timely completion of enrollment in this important study, keeping us on track to announce topline results later this year. This human challenge study was conducted in the United Kingdom and was designed to evaluate a favorable safety profile, virological effects, and an improvement in clinical symptom for CC-42344 as a potential oral treatment for avian pandemic and seasonal influenza A,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “We are pleased to advance our robust pipeline with achievement of this important clinical development milestone as we continue to build our leadership in influenza therapeutics.”
In March 2024 Cocrystal announced receipt of positive Pre-Investigational New Drug (Pre-IND) feedback from the FDA providing guidance and clarification on critical steps including designing a proposed Phase 2b study protocol for CC-42344 as a potential oral treatment for pandemic and seasonal influenza A.
Cocrystal also plans to begin a Phase 1 study in Australia with an inhaled formulation of CC-42344 as a potential influenza A treatment and post-exposure prophylaxis. Recent preclinical data showed that inhaled CC-42344 exhibited highly effective delivery into the lung, superior lung exposure, efficacy in influenza-infected human lung epithelia and a favorable safety profile.
CC-42344 Influenza A PB2 Inhibitor
In December 2023, Cocrystal 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. The randomized, double-blind, placebo-controlled study was designed to evaluate the safety, tolerability, viral and clinical measurements of influenza A infection in subjects dosed with oral CC-42344 treatment. The study enrolled 78 healthy subjects.
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.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected timing and results of the Phase 2a trial for CC-42344 for the oral treatment of influenza A in 2024, an anticipated Phase 2b trial for oral treatment of influenza A following the Phase 2a trial, plans to begin a Phase 1 study in Australia for an inhaled formulation of CC-42344 as a potential influenza A treatment and prophylaxis, and the potential efficacy and clinical benefits of, and market for, such product candidates. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, risks relating to our ability to proceed with the studies including recruiting volunteers and procuring materials for such studies by our clinical research organizations and vendors, the results of such studies and our ability to obtain FDA approval to initiate the Phase 2b study. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2023. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
FDA feedback following the Company’s submission of a Pre-IND briefing package improves clarity on regulatory requirements for Phase 2b influenza A clinical trial with oral CC-42344, a broad-spectrum PB2 inhibitor
Topline data expected in 2024 from Phase 2a influenza A human challenge study and Phase 1 study with oral CDI-988, the first potential dual coronavirus-norovirus oral antiviral
Initiation of Phase 1 study expected in 2024 with inhaled CC-42344, a potential influenza treatment and post-exposure prophylactic
BOTHELL, Wash., March 28, 2024 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company) reports financial results for the 12 months ended December 31, 2023, and provides updates on its antiviral product pipeline, upcoming milestones and business activities.
“We are highly encouraged by the FDA’s feedback to our Pre-Investigational New Drug (Pre-IND) package, which provides greater clarity on the regulatory requirements for a planned Phase 2b clinical trial with our novel broad-spectrum oral PB2 inhibitor CC-42344 for pandemic and seasonal influenza A,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “This is a major step in the clinical and regulatory process for this program. We plan to file an IND for late-stage clinical development of oral CC-42344 that includes data from our ongoing Phase 2a human challenge study, which are expected later this year.
“During 2024 we also expect to initiate a Phase 1 study in healthy volunteers with inhaled CC-42344 as a potential prophylactic and therapeutic for influenza A. Our inhaled formulation of CC-42344 has shown the ability to directly target influenza-infected respiratory epithelial cells in lung, allowing for higher accumulation of drug in the pulmonary system and potentially producing a rapid clinical response while reducing potential systemic side effects,” he added. “Also during the coming year we expect topline data from the ongoing first-in-human study with our pan-coronavirus and pan-norovirus oral protease inhibitor CDI-988, which is expected to serve as a Phase 1 study for both indications.”
“All our programs target high-value unmet indications with novel, broad-spectrum, best-in-class antiviral candidates whose design and development uses our proprietary structure-based drug discovery platform technology,” said James Martin, CFO and co-CEO. “I’m pleased to report that under our cost-efficient business model, we believe our cash position is sufficient to fund current operations including planned clinical studies beyond the next 12 months.”
Antiviral Product Pipeline Overview
We are developing therapeutics that inhibit the viral replication function of RNA viruses that cause acute and chronic diseases. Our drug-discovery process focuses on the highly conserved regions of the viral enzymes and inhibitor-enzyme interactions at the atomic level. By designing and selecting antiviral drug candidates that interrupt the viral replication process and have specific binding characteristics, we seek to develop drugs that are effective against the virus and mutations of the virus, and also have reduced off-target interactions that may cause undesirable side effects. Our drug discovery process differs from traditional, empirical medicinal chemistry approaches that often require iterative high-throughput compound screening and lengthy hit-to-lead processes.
Influenza Programs Influenza is a severe respiratory illness that is caused by the influenza A or B virus and results in disease outbreaks mainly during the winter months. Influenza is a major global health threat that may become more challenging to treat in the future due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals.
Our novel PB2 inhibitor CC-42344 has shown excellent in vitro antiviral activity against influenza A strains including pandemic and seasonal strains, as well as strains that are resistant to Tamiflu® and Xofluza®.
In March 2022 we initiated enrollment in a randomized, double-blind, dose-escalating Phase 1 study to evaluate the safety, tolerability and pharmacokinetics (PK) of oral CC-42344 in healthy adults.
In July 2022 we reported PK results from the single-ascending dose portion of the study that support once-daily dosing.
In December 2022 we reported favorable safety and tolerability results from the oral CC-42344 Phase 1 study.
In October 2023 we announced authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency to conduct a Phase 2a human challenge study.
In December 2023 we began treating influenza-infected subjects in the randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, viral and clinical measurements of influenza A infection in subjects treated with oral CC-42344.
In March 2024 we received feedback from the FDA on a Pre-IND package improving clarity on clinical trial design, drug manufacturing and nonclinical studies necessary to file a Phase 2b trial design.
Preclinical development is underway with inhaled CC-42344 as a potential therapeutic and post-exposure prophylaxis for influenza A. CC-42344 has exhibited superior pulmonary exposure in preclinical testing. We expect to begin a Phase 1 clinical study with inhaled CC-42344 in Australia in 2024.
Influenza A/B Program
Preclinical lead optimization of replication inhibitor antiviral candidates is underway.
COVID-19 and Other Coronavirus Programs By targeting viral replication enzymes and protease, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including COVID-19, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). Our main SARS-CoV-2 protease inhibitors showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses that cause the common cold, as well as against noroviruses that can cause symptoms of acute gastroenteritis. Driven by the anticipated emergence of new COVID-19 variants, the global COVID-19 therapeutics market is estimated to exceed $16 billion by the end of 2031.
Oral Protease Inhibitor CDI-988
In October 2022 we announced the selection of CDI-988 as our lead candidate for development as a potential oral treatment for SARS-CoV-2. CDI-988 exhibited superior in vitro potency against SARS-CoV-2 with activity maintained against variants of concern, and demonstrated a safety profile and PK properties that support once-daily dosing.
In May 2023 we announced approval of our application to the Australian regulatory agency for a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability and PK of oral CDI-988 in healthy volunteers.
In August 2023 we announced the selection of CDI-988 as our lead oral candidate for norovirus, in addition to coronavirus.
In September 2023 we dosed the first subject in our dual norovirus-coronavirus oral CDI-988 study, which is expected to serve as a Phase 1 study for both indications.
We expect topline data from the Phase 1 study with CDI-988 in 2024.
Norovirus Program Norovirus is a highly contagious infection and is the most common cause of acute gastroenteritis, accounting for nearly one in five cases. According to the Centers for Disease Control and Prevention (CDC), an estimated 685 million cases and an estimated 200,000 deaths are attributed to norovirus each year worldwide, with an estimated societal cost of $60 billion.
3CL inhibitor CDI-988 has shown pan-viral activity against multiple norovirus strains, including the genogroup II, genotype 4 (GII.4) norovirus strain that is responsible for major norovirus outbreaks. By targeting viral replication, we believe it is possible to develop an effective treatment or short-term prophylactic for closed environments for all genogroups of norovirus.
In August 2023 we announced our selection of the novel broad-spectrum oral 3CL protease inhibitor CDI-988 as our lead potential oral treatment for norovirus, in addition to coronavirus.
In September 2023 we began subject dosing in a first-in-human study in healthy volunteers in Australia. The randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK of oral CDI-988 in healthy volunteers is expected to serve as a Phase 1 study for both indications.
We expect topline data from the Phase 1 study with CDI-988 in 2024.
2023 Financial Results
Research and development (R&D) expenses for 2023 were $15.2 million, compared with $12.4 million for 2022. The increase was primarily due to advancing influenza candidate CC-42344 into a Phase 2a study and advancing the dual norovirus-coronavirus candidate CDI-988 into a Phase 1 study. General and administrative (G&A) expenses for 2023 were $6.0 million, compared with $5.7 million for 2022.
During 2023 the Company received $2.6 million related to litigation with an insurer, which included a $1.6 million refund from the registry of the United States Court of Appeals for the Third Circuit, reflecting the recovery of funds following a successful appeal, and $1.0 million in a settlement agreement with the insurer.
Interest income for 2023 was $640,000, compared with interest expense of $2,000 for 2022. The interest income in 2023 was related to interest earned from cash held in banks and deposits with the court registry, and the interest expense in 2022 was related to finance lease agreements.
The net loss for 2023 was $18.0 million, or $1.87 per share, compared with the net loss for 2022 of $38.8 million, or $4.77 per share, which included a $19.1 million non-cash impairment-loss of goodwill.
Cocrystal reported unrestricted cash as of December 31, 2023 of $26.4 million, compared with $37.1 million as of December 31, 2022. Net cash used in operating activities for 2023 was $14.7 million, compared with $21.4 million for 2022. The Company had working capital of $25.0 million and 10.2 million common shares outstanding as of December 31, 2023.
About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans for the future development of preclinical and clinical drug candidates, our expectations regarding future characteristics of the product candidates we develop, the expected time of achieving certain value-driving milestones in our programs, including preparation, commencement and advancement of clinical studies for certain product candidates in 2024, the viability and efficacy of potential treatments for diseases our product candidates are designed to treat, expectations for the markets for certain therapeutics, our ability to execute our clinical and regulatory goals and deploy regulatory guidance towards future studies, the expected sufficiency of our cash balance to advance our programs and fund our planned operations, and our liquidity. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from the high interest rates in response to inflation, uncertainty in the financial markets, the possibility of a recession and geopolitical conflict in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., UK, Australia and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions on our ability to proceed with studies as well as similar problems with our vendors and our current and any future clinical research organization (CROs) and contract manufacturing organizations (CMOs), the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes, and potential development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2023. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
BOTHELL, Wash., Jan. 04, 2024 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) provides 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 Cocrystal’s unique structure-based drug discovery technology platform to be effective on a broad range of viruses causing these diseases.
“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,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “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 this year.
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 this year. In 2022 Cocrystal reported favorable safety and tolerability results in the healthy volunteer Phase 1 study with CC-42344 conducted in Australia.
About Norovirus
Although norovirus is a worldwide public health problem, there are no effective treatments or vaccines. Norovirus afflicts an estimated 685 million people annually at an estimated societal cost of $60 billion. About 200 million cases are seen among children under 5 years old, leading to an estimated 50,000 child deaths every year, mostly in developing countries, according to the Centers for Disease Control and Prevention (CDC). CDI-988 in vitro studies showed potent broad-spectrum antiviral activity against a panel of pandemic GII.4 norovirus proteases, which have caused the majority of norovirus outbreaks worldwide since 2002, and a favorable pharmacokinetic property targeting the gastrointestinal tract.
About COVID-19 COVID-19 hospitalizations have recently increased in the U.S. with the new JN.1 variant responsible for about 20% of these cases. Driven by the anticipated emergence of new COVID-19 variants, the global COVID-19 therapeutics market is estimated to exceed $16 billion by the end of 2031. The ability of someone with no symptoms to transmit infection to another person has heightened the public health challenge of COVID-19. CDI-988 exhibited superior in vitro potency against SARS-CoV-2 with activity maintained against variants of concern. By targeting the viral replication protease, Cocrystal believes it is possible to develop an effective treatment for all coronaviruses, including COVID-19 and its variants, as well as for Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS).
About Cocrystal Pharma, Inc. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2) noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the promise and potential of the two product candidates, the clinical development of CC-42344 as a product candidate for oral antiviral inhibitor for the treatment of pandemic and seasonal influenza A and the Phase 2a study for such product candidate, CC-988 as a product candidate for dual oral antiviral inhibitor for the treatment of coronavirus and norovirus and the Phase 1 study for such product candidate, the potential efficacy and clinical benefits of, and market for, such product candidates, and the expected results and topline data from these clinical trials in 2024. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, risks relating to our ability to proceed with the studies including recruiting volunteers and procuring materials for such studies by our clinical research organizations and vendors, and the results of such studies. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2022. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
BOTHELL, Wash., Dec. 06, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces 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.
“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,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “We expect to report topline data from this clinical trial in 2024.”
“We are excited about the potential CC-42344 holds to create a paradigm shift in the treatment of one the world’s most common viral infections,” added James Martin, Cocrystal’s CFO and co-CEO. “Currently approved antiviral treatments for influenza are prone to viral resistance, increasing the need for improved influenza treatments for patients that also provide significant cost savings to the global healthcare system.”
About Cocrystal Pharma, Inc. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2) noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the initiation and characteristics of a Phase 2a study for CC-42344 as a product candidate for oral antiviral inhibitor for the treatment of pandemic and seasonal influenza A, the potential efficacy and clinical benefits of, and market for, such product candidate, and the expected results and topline data from this clinical trial in 2024. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, risks relating to our ability to proceed with the Phase 2a study including recruiting volunteers and procuring materials for such study by our clinical research organizations and vendors, and the results of such study. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2022. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
BOTHELL, Wash., Nov. 29, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), announces the presentation of favorable data demonstrating activity of its potent broad-spectrum PB2 inhibitor CC-42344 against pandemic and seasonal influenza A strains at the World Vaccine Congress West Coast. Cocrystal has initiated a Phase 2a human challenge trial with oral CC-42344 in the UK in subjects infected with influenza A, and plans to begin a Phase 1 trial with inhaled CC-42344 as a potential influenza A treatment and prophylaxis in Australia in the first half of 2024.
In his presentation, “Taking a new route: Development of novel inhaled and oral influenza antiviral, CC-42344,” Cocrystal President and co-CEO Sam Lee, PhD discussed the potential prevention and therapy of influenza infection using inhaled CC-42344. Dr. Lee commented that CC-42344 exhibits superior antiviral activity compared with oseltamivir (Tamiflu®) and demonstrates a novel mechanism of action with high barrier of resistance. He noted that Cocrystal discovered and developed CC-42344 utilizing the Company’s proprietary structure-based drug discovery platform technology, which is proving successful in delivering multiple broad-spectrum antiviral leads for influenza and other viral diseases.
“We are excited to accomplish another important milestone with the influenza antiviral CC-42344. Based on our recent preclinical data, CC-42344 exhibits superior lung exposure, a favorable safety profile, and efficacy in influenza-infected human lung epithelia. We also demonstrated highly efficient delivery of inhaled CC-42344 into the lung,” he said. “Inhaled CC-42344 could be developed for both therapeutic and prophylactic influenza treatment. We are encouraged by this potential breakthrough influenza treatment option.”
Slides from the presentation are available on the Company’s website.
About CC-42344 CC-42344 is specifically designed to be effective against all significant pandemic and seasonal influenza A strains and to have a high barrier to resistance due to the way the virus’ replication machinery is targeted. CC-42344 targets the influenza polymerase, an essential replication enzyme with several highly essential regions common to multiple influenza strains. In vitro testing showed CC-42344’s excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant to certain approved influenza antivirals, while also demonstrating favorable pharmacokinetic and safety profiles.
About Cocrystal Pharma, Inc. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2) noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s ongoing Phase 2a human challenge trial for CC-42344 as a product candidate for oral treatment of influenza A, and the planned initiation of a Phase 1 clinical trial in the first half of 2024 for CC-42344 as a product candidate for inhaled treatment of influenza A, and the potential efficacy and clinical benefits of, and market for, such product candidate. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, risks relating to our ability to proceed with the Phase 2a and Phase 1 studies referred to above including recruiting volunteers for and procuring or manufacturing materials for such studies by our clinical research organizations and vendors, and the results of such studies. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2022. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
BOTHELL, Wash., Nov. 27, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that James Martin, Chief Financial Officer and Co-Chief Executive Officer, will present a Company overview at Noble Capital Markets’ 19th Annual Emerging Growth Equity Conference on Monday, December 4 at 1:30 p.m. Eastern time. The conference is being held December 3-5 at the College of Business Executive Education Building at Florida Atlantic University in Boca Raton, Fla.
“The coming year promises to be highly eventful with data expected from several of our antiviral development programs,” said Mr. Martin. “We are actively enrolling subjects in a Phase 1 clinical trial with our oral potent pan-coronavirus and pan-norovirus protease inhibitor CDI-988. With a Phase 2a human challenge clinical trial of our oral PB2 inhibitor CC-42344 for the treatment of pandemic and seasonal influenza A, we are on track to begin dosing subjects in the very near term. We look forward to keeping our shareholders updated and sharing near-term milestones at NobleCon 19 and future investment conferences.”
A webcast of the Cocrystal presentation will be available beginning December 5 on the Company’s website and will be archived for 90 days following the event.
About Cocrystal Pharma, Inc. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2) noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the initiation and expected data from the Company’s antiviral development programs for CC-42344 as a product candidate for oral treatment of influenza A and CC-988 for oral treatment of coronavirus and norovirus. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, risks relating to the manufacturing and research delays arising from labor shortages and other factors, the ability of our Clinical Research Organization partners to recruit volunteers for, and to proceed with, clinical trials, and general risks arising from or involved in conducting clinical studies for CC-988 and CC-42344, including the results of such studies. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2022. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
3Q23 Reported. Cocrystal reported a 3Q23 loss of $4.2 million or $(0.41) per share. The loss included a reversal of a 2Q22 legal charge of $1.6 million after a verdict was overturned by an Appeals Court and money returned to the company. During 3Q23, clinical progress included the start of the Phase 1 trial testing CDI-988 in pan-coronavirus and pan-norovirus trials, and authorization to begin a Phase 2a human challenge study in influenza A.
CC-42344 To Start Clinical Trials Shortly. Cocrystal has received authorization from the UK’s MHRA (Medicines and Healthcare Regulatory Agency) to begin Phase 2a testing CC-42344, its orally administered protease inhibitor for influenza A. This placebo-controlled trial will administer a pharmaceutically prepared dose of influenza virus to infect healthy volunteers with, then test the safety and immunologic measurements of CC-42344 against the virus. Separately, Dr. Sam Lee, President and Co-CEO is scheduled to make a presentation at the World Vaccine Congress West Coast on the development of CC-42344 on November 28.
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Enrollment underway in Phase 1 trial with novel protease inhibitor CDI-988, the first potential dual coronavirus-norovirus oral antiviral
Dosing expected to begin later this year in Phase 2a human challenge trial with oral CC-42344 for the treatment of pandemic and seasonal influenza A
Phase 1 trial with inhaled CC-42344 expected to begin in the first half of 2024
BOTHELL, Wash., Nov. 13, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company) reports financial results for the three and nine months ended September 30, 2023, and provides updates on its antiviral pipeline, upcoming milestones and business activities.
“We are making excellent progress in the clinical development of potent antivirals that address some of the world’s leading viral diseases,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “With our novel oral PB2 inhibitor CC-42344 for the treatment of pandemic and seasonal influenza A, we expect to dose the first subjects in a Phase 2a human challenge study before year-end. We also are on track to begin a Phase 1 healthy volunteer trial in the first half of 2024 with inhaled CC-42344 as a potential therapeutic and prophylactic treatment for influenza A.
“Enrollment is underway in a Phase 1 trial with our first-in-class pan-coronavirus and pan-norovirus protease inhibitor CDI-988,” added Dr. Lee. “This oral potent antiviral candidate could reduce severity and death from pandemic outbreaks of highly contagious viral infections. CDI-988 has shown activity against multiple coronavirus and norovirus strains, including the genogroup II, genotype 4 (GII.4) norovirus strain, which is responsible for major norovirus outbreaks. With no approved treatments or vaccines, norovirus represents a significant unmet medical need.”
“With three clinical-stage antiviral programs in high-value unmet medical indications, the coming year promises to be active and potentially transformational for Cocrystal,” said James Martin, CFO and co-CEO. “I’m pleased to report that under our cost-efficient business model, we believe our current cash position is sufficient to fund planned operations beyond the next 12 months.”
Antiviral Product Pipeline Overview
We are developing therapeutics that inhibit the viral replication function of RNA viruses that cause acute and chronic diseases. Our drug-discovery process focuses on the highly conserved regions of the viral enzymes and inhibitor-enzyme interactions at the atomic level. By designing and selecting antiviral drug candidates that interrupt the viral replication process and have specific binding characteristics, we seek to develop drugs that are effective against the virus and mutants of the virus, and also have reduced off-target interactions that may cause undesirable side effects. Our drug discovery process differs from traditional, empirical medicinal chemistry approaches that often require iterative high-throughput compound screening and lengthy hit-to-lead processes.
Influenza Programs
Influenza is a severe respiratory illness caused by the influenza A or B virus that results in disease outbreaks mainly during the winter months. Influenza is a major global health threat that may become more challenging to treat in the future due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals.
Our novel oral PB2 inhibitor CC-42344 has shown excellent in vitro antiviral activity against influenza A strains including pandemic and seasonal strains, as well as strains that are resistant to Tamiflu® and Xofluza®.
In March 2022 we initiated enrollment in a randomized, double-controlled, dose-escalating Phase 1 trial to evaluate the safety, tolerability and pharmacokinetics (PK) of orally administered CC-42344 in healthy adults.
In July 2022 we reported PK results from the single-ascending dose portion of the trial that support once-daily dosing.
In December 2022 we reported favorable safety and tolerability results from the CC-42344 Phase 1 trial.
In October 2023 we announced authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency to conduct a Phase 2a human challenge trial and we expect to begin treating influenza-infected subjects in this trial during the fourth quarter of 2023.
Preclinical development is underway with inhaled CC-42344 as a potential therapeutic treatment and prophylaxis for influenza A. We expect to begin a Phase 1 clinical trial with inhaled CC-42344 in Australia in the first half of 2024.
Pandemic and Seasonal Influenza A/B Program
In January 2019 we entered into an Exclusive License and Research Collaboration Agreement with Merck Sharp & Dohme Corp. (Merck) to discover and develop certain proprietary influenza antiviral agents that are effective against 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 we announced completion of all research obligations under the agreement, making Merck solely responsible for further preclinical and clinical development of these compounds.
In early 2023 Merck notified us of its intent to continue development of the compounds discovered under this agreement and of their filing on behalf of both companies of multiple U.S. and international patent applications associated with these compounds. Merck continues to be responsible for managing the patents.
COVID-19 and Other Coronavirus Programs
By targeting viral replication enzymes and protease, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including COVID-19, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). Our main SARS-CoV-2 protease inhibitors showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses that cause the common cold, as well as against noroviruses that can cause symptoms of acute gastroenteritis. Driven by the anticipated emergence of new COVID-19 variants, the global COVID-19 therapeutics market is estimated to exceed $16 billion by the end of 2031.
Oral Protease Inhibitor CDI-988
In October 2022 we announced the selection of CDI-988 as our lead candidate for development as a potential oral treatment for SARS-CoV-2. Designed and developed using our proprietary structure-based drug discovery platform technology, CDI-988 targets a highly conserved region in the active site of SARS-CoV-2 3CL (main) protease required for viral RNA replication.
CDI-988 exhibited superior in vitro potency against SARS-CoV-2 with activity maintained against variants of concern, and demonstrated a safety profile and PK properties that support once-daily dosing.
In May 2023 we announced approval of our application to the Australian regulatory agency for a planned randomized, double-blind, placebo-controlled Phase 1 trial to evaluate the safety, tolerability and PK of oral CDI-988 in healthy volunteers.
In September 2023 we dosed the first subject in the CDI-988 Phase 1 trial.
Intranasal/Pulmonary Protease Inhibitor CDI-45205
CDI-45205 is our novel SARS-CoV-2 3CL (main) protease inhibitor and was among the broad-spectrum viral protease inhibitors we obtained from Kansas State University Research Foundation (KSURF) under an exclusive license agreement announced in April 2020. We believe the protease inhibitors obtained from KSURF have the ability to convert the inactive SARS-CoV-2 polymerase replication enzymes into an active form.
CDI-45205 and several analogs showed potent in vitro activity against the main SARS-CoV-2 variants, surpassing the activity observed with the original Wuhan strain of the virus.
CDI-45205 delivered via intraperitoneal injection demonstrated good bioavailability in mouse and rat PK studies, 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.
In January 2022 we received guidance from the FDA regarding further preclinical and clinical development of CDI-45205.
Norovirus Program
Norovirus is a highly contagious infection and is the most common cause of acute gastroenteritis, accounting for nearly one in five cases. According to the Centers for Disease Control and Prevention (CDC), an estimated 685 million cases and an estimated 200,000 deaths are attributed to norovirus each year worldwide, with an estimated societal cost of $60 billion.
In August 2023 we announced our selection of the novel broad-spectrum 3CL protease inhibitor CDI-988 as our lead potential oral treatment for norovirus. CDI-988 is being evaluated in a first-in-human trial in healthy volunteers in Australia. The CDI-988 trial is expected to serve as a Phase 1 trial for both our norovirus and our coronavirus programs.
In September 2023 we dosed the first subject in our dual norovirus-coronavirus oral CDI-988 Phase 1 trial.
Third Quarter Financial Results
Research and development (R&D) expenses for the third quarter of 2023 were $4.2 million, compared with $3.9 million for the third quarter of 2022. The increase was primarily due to the influenza CC-42344 product candidate moving into a Phase 2a clinical trial and the ongoing Phase 1 clinical trial of CDI-988 for norovirus-coronavirus. General and administrative (G&A) expenses for the third quarters of 2023 and 2022 were relatively stable at $1.8 million.
During the third quarter of 2023, the Company received a $1.6 million refund from the registry of the court reflecting the recovery of funds following a successful appeal in the Company’s litigation with an insurer, which created a positive impact by reducing operating expenses by that amount.
Total other income, net for the third quarter of 2023 was $0.3 million, which was primarily related to interest earned on cash in bank accounts. This compared with minimal other expense, net for the third quarter of 2022.
The net loss for the third quarter of 2023 was $4.2 million, or $0.41 per share, compared with the net loss for the third quarter of 2022 of $5.7 million, or $0.70 per share.
Nine Month Financial Results
R&D expenses for the nine months ended September 30, 2023 were $10.9 million, compared with $9.1 million for the nine months ended September 30, 2022, with the increase primarily due to clinical advancement of our Influenza A and norovirus-coronavirus programs. G&A expenses for the first nine months of 2023 were $4.6 million, compared with $4.5 million for the first nine months of 2022.
During the first nine months of 2023, the Company received a $1.6 million refund from the registry of the court, as noted above. The Company obtained a summary judgment during the second quarter of 2022 and accounted for a potential $1.6 million adverse award by expensing the same amount during the first nine months of 2022.
During the first nine months of 2022, the Company recorded a $19.1 million non-cash goodwill impairment. There was no comparable impairment charge during the first nine months of 2023.
Total other income, net for the first nine months of 2023 was $0.4 million, compared with minimal other expense, net for the first nine months of 2022.
The net loss for the nine months ended September 30, 2023 was $13.5 million, or $1.43 per share. The net loss for the nine months ended September 30, 2022 was $34.3 million, or $4.23 per share, and reflected the litigation expense and non-cash impairment charge described above.
Cocrystal reported unrestricted cash as of September 30, 2023 of $29.7 million, compared with $37.1 million as of December 31, 2022. Net cash used in operating activities for the first nine months of 2023 was $11.3 million, compared to $16.5 million for the first nine months of 2022. The Company had working capital of $30.3 million and 10.2 million common shares outstanding as of September 30, 2023.
About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans for the future development of preclinical and clinical drug candidates, our expectations regarding future characteristics of the product candidates we develop, the expected time of achieving certain value-driving milestones in our programs, including, preparation, commencement and advancement of clinical studies for certain product candidates in 2023 and beyond, the viability and efficacy of potential treatments for diseases our product candidates are designed to treat, expectations for the markets for certain therapeutics, our ability to execute our clinical and regulatory goals and deploy regulatory guidance towards future studies, the expected sufficiency of our cash balance to advance our programs and fund our planned operations, and our liquidity. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from interest rate increases in response to inflation, uncertainty in the financial markets, the possibility of a recession and geopolitical conflict in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., UK, Australia and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions on our ability to proceed with studies as well as similar problems with our vendors and our current and any future clinical research organization (CROs) and contract manufacturing organizations (CMOs), the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, our reliance on Merck for further development in the influenza A/B program under the license and collaboration agreement, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, and the outcome of the ongoing litigation with the insurance company. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2022. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Operating lease right-of-use assets, net (including $57 and $99 respectively, to related party)
111
274
Total assets
$
32,614
$
40,840
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses
$
1,806
$
976
Current maturities of finance lease liabilities
–
7
Current maturities of operating lease liabilities (including $57 and $59 respectively, to related party)
118
233
Total current liabilities
1,924
1,216
Long-term liabilities:
Operating lease liabilities (including $0 and $42 respectively, to related party)
–
57
Total liabilities
1,924
1,273
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par value 150,000 shares authorized as of September 30, 2023, and December 31, 2022; 10,174 and 8,143 shares issued and outstanding as of September 30, 2023 and December 31, 2022
10
8
Additional paid-in capital
342,130
337,489
Accumulated deficit
(311,450
)
(297,930
)
Total stockholders’ equity
30,690
39,567
Total liabilities and stockholders’ equity
$
32,614
$
40,840
COCRYSTAL PHARMA, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except per share data)
BOTHELL, Wash., Nov. 09, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), announces that President and co-CEO Sam Lee, PhD will discuss progress in developing the novel, broad-spectrum PB2 inhibitor CC-42344 in an oral presentation, “Taking a new route: Development of novel inhaled and oral influenza antiviral, CC-42344” at the World Vaccine Congress West Coast on Tuesday, November 28, 2023 at 3:20 p.m. Pacific Time. The conference is being held November 27-30 at the Santa Clara Convention Center in Santa Clara, Calif.
“It is highly gratifying to be selected for an oral presentation at this prestigious gathering to discuss the significant progress we’ve made in developing CC-42344 for the treatment of pandemic and seasonal influenza A,” said Dr. Lee. “We recently announced authorization by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) to initiate a Phase 2a human challenge trial with orally administered CC-42344 and we expect to begin treating influenza-infected patients later in this quarter. Additionally, preparations are underway to begin a Phase 1 clinical trial in the first half of 2024 with an inhaled CC-42344 formulation as a potential treatment and prophylaxis for influenza A.”
Following the presentation, Cocrystal will issue a press release with highlights from Dr. Lee’s discussion and the slide presentation will be available on the Company’s website.
About CC-42344 CC-42344 is an PB2 inhibitor that blocks an essential step of viral replication and was discovered using Cocrystal’s proprietary structure-based drug discovery platform technology. It is specifically designed to be effective against all significant pandemic and seasonal influenza A strains and to have a high barrier to resistance due to the way the virus’ replication machinery is targeted. CC-42344 targets the influenza polymerase, an essential replication enzyme with several highly essential regions common to multiple influenza strains. In vitro testing showed CC-42344’s excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant to certain approved influenza antivirals, while also demonstrating favorable pharmacokinetic and safety profiles.
About Cocrystal Pharma, Inc. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2) noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the initiation and characteristics of a Phase 2a human challenge trial in 2023 for CC-42344 as a product candidate for oral treatment of influenza A, and a Phase 1 clinical trial in 2024 for CC-42344 as a product candidate for inhaled treatment of influenza A, and the potential efficacy and clinical benefits of, and market for, such product candidate. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, risks relating to the manufacturing and research delays arising from labor shortages and other factors, the ability of our Clinical Research Organization partners to recruit volunteers for, and to proceed with, clinical trials, and general risks arising from or involved in conducting clinical studies for CC-42344, including the results of such studies. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2022. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Phase 2a Trial Expected To Begin In The UK Before Year-End. Cocrystal announced that it has received authorization from the United Kingdom’s Medicines Health and Regulatory Agency to begin its Phase 2a clinical trial. This Phase 2a trial will be conducted in the UK and test CC42344 in seasonal and pandemic influenza. The trial is expected to begin before the end of 2023 with results expected around mid-2024.
Study Was Designed To Test Hunan Volunteers In A Controlled Setting. The study will be a single-center, placebo-controlled study designed to challenge healthy human volunteers with influenza A. Subjects will receive pharmaceutically-produced influenza A virus on the first day. This will be followed 24 hours later by either CC-42344 or placebo once daily for 5 days. Endpoints in the trial are changes in viral load, symptoms, and biomarkers, as well as safety and tolerability.
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