Board Change • May 21
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 2 highly experienced directors. Independent Director Fred Hassan was the last director to join the board, commencing their role in 2023. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Apr 02
Cocrystal Pharma Announces FDA Fast Track Designation For CDI-988 For Norovirus Infection Treatment And Preventive Cocrystal Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its oral, direct-acting protease inhibitor, CDI-988, the first oral antiviral candidate being developed for treatment and prophylaxis of norovirus infection. FDA Fast Track designation aims to facilitate the development and accelerate the review process for drugs that treat serious conditions and address unmet medical needs. The designation enables early and frequent communication with the FDA throughout the development process, allows for rolling review of a New Drug Application (NDA), and may qualify a product for Priority Review at the time of NDA submission. CDI-988 was designed and developed as an inhibitor of a highly conserved region of noroviruses, coronaviruses, and other 3CL viral proteases. A Phase 1b norovirus challenge study is underway at Emory University School of Medicine to evaluate CDI-988 to both prevent and treat norovirus infection. Norovirus is responsible for an estimated 685 million global cases each year and approximately $60 billion in worldwide economic impact. In the United States alone, the virus is associated with 21 million infections annually, resulting in around 109,000 hospitalizations, 465,000 emergency department visits, and 900 deaths. The estimated annual economic burden in the U.S. exceeds $10.6 billion. In developing nations, norovirus contributes to up to 1,100,000 hospitalizations and 218,000 pediatric deaths each year. Cocrystal’s ongoing Phase 1b randomized, double-blind, placebo-controlled challenge study (NCT07198139) at Emory University School of Medicine will evaluate CDI-988 in up to 40 healthy adults. The primary endpoint is a reduction in the incidence of clinical symptoms, with secondary endpoints assessing viral shedding, disease severity, safety, and pharmacokinetics. Cocrystal is leveraging its structure-based drug discovery platform technology to design next-generation antiviral candidates that precisely target viral replication mechanisms. By binding to highly conserved regions of viral enzymes, the Company’s compounds aim to maintain potency against mutating strains while minimizing off-target effects, offering potentially safer, broad-spectrum antiviral solutions. This approach streamlines candidate identification and optimization, enabling more rapid progression of promising therapies with robust resistance and safety profiles. Announcement • Mar 10
Cocrystal Pharma, Inc Announces First Subjects Dosed in Phase 1B Study Evaluating Cdi-988 for Norovirus Prevention and Treatment Cocrystal Pharma, Inc. announced the first subjects have been dosed in a Phase 1b norovirus challenge study (NCT07198139) to evaluate CDI-988 as both a preventive and treatment for norovirus infections. This cohort is to assess the infectivity rate of the challenge inoculum, GII.2 (Snow Mountain Virus). CDI-988 is a direct-acting, oral antiviral designed to inhibit a highly conserved region of the viral 3CL protease present in all known norovirus strains, including GII.2, GII.4 and recently re-emerging GII.17 variants. It is the first oral antiviral drug candidate developed for norovirus acute gastroenteritis. The Phase 1b randomized, double-blind, placebo-controlled study is being conducted at Emory University School of Medicine and will enroll up to 40 healthy subjects ages 18–49. All participants will be infected with the norovirus GII.2 (Snow Mountain Virus) strain. The first cohort will evaluate the infectivity rate of the challenge inoculum, GII.2 norovirus. Subsequent cohorts will be orally administered CDI-988 or placebo. The primary endpoint is efficacy versus placebo in reducing the incidence of clinical symptoms. Secondary endpoints include reduction of viral shedding and disease severity, and safety and pharmacokinetic profiles. CDI-988 previously demonstrated favorable safety and tolerability in a Phase 1 study across all dose levels, including the highest dose of 1200 mg being administered in the Phase 1b human challenge study. In September 2025 Cocrystal received a Study May Proceed Letter from the FDA and in December 2025 received Institutional Review Board approval from Emory University School of Medicine. Announcement • Feb 20
Cocrystal Pharma's First Oral Norovirus Protease Inhibitor CDI-988 to Be Featured at the International Society for Antiviral Research Conference (ICAR) 2026 Cocrystal Pharma, Inc. announced that initial progress of a norovirus challenge study with its direct-acting, oral antiviral inhibitor CDI-988 will be presented at the 39thInternational Conference on Antiviral Research (ICAR2026), being held April 27-May 1 in Prague, Czech Republic. CDI-988 is the first oral antiviral drug candidate under development for the prevention and treatment of acute norovirus gastroenteritis. This infection spreads rapidly in semi-closed and crowded settings such as hospitals, nursing homes, cruise ships, schools, disaster-relief shelters and military facilities, where close contact makes outbreaks especially difficult to control. Norovirus causes an estimated 200,000 deaths worldwide each year at a societal cost of approximately $60 billion. In the U.S., norovirus is responsible for about 21 million cases of acute gastroenteritis annually, including 109,000 hospitalizations, 465,000 emergency department visits and nearly 900 deaths, with an estimated annual economic burden of $10.6 billion. Announcement • Dec 19
Cocrystal Pharma, Inc. Receives IRB Approval from Emory University School of Medicine for Phase 1b Human Challenge Study with CDI-988 for Prevention and Treatment of Norovirus Cocrystal Pharma, Inc. announced the approval from the Institutional Review Board (IRB) at Emory University School of Medicine to initiate a Phase 1b human challenge study with CDI-988. Initial screening of study subjects is currently underway, with enrollment expected to begin in the first quarter of 2026. The IRB approval from Emory University School of Medicine follows Cocrystal's prior regulatory milestones, including U.S. Food and Drug Administration (FDA) clearance of its investigational New Drug (IND) application. CDI-988 is the first oral antiviral drug candidate developed for the prevention and treatment of norovirus acute gastroenteritis. CDI-988 was designed with Cocrystal's proprietary structure-based drug discovery platform technology. In August 2025 Cocrystal announced favorable Phase 1 safety and tolerability data from all CDI-988 dose cohorts including the highest dose of 1200 mg. In September 2025 the Company received a Study May Proceed Letter from the FDA for the Phase 1b challenge study. Announcement • Oct 30
Cocrystal Pharma, Inc. announced that it has received $1.032803 million in funding Cocrystal Pharma, Inc. announces the completion of a private placement to issue 743,024 shares of its common stock at a price of $1.39 per share for gross proceeds of $1,032,803.36 on October 30, 2025. The four Investors in the private placement are Cocrystal Directors Phillip Frost, M.D., who co-founded the Company and serves as Chairman and CEO of OPKO Health, Inc., Fred Hassan, who is Chairman of the investment firm Caret Group and Director of the private equity firm Warburg Pincus and Richard Pfenniger, and Cocrystal co-CEO and CFO James Martin. Securities are issued pursuant to Regulation D. Announcement • Oct 27
Cocrystal Pharma, Inc. Receives NIH SBIR Award to Advance Its Influenza Inhibitor Program Cocrystal Pharma, Inc. announced it has received a Small Business Innovation Research (SBIR) Phase I award from the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID). This approximately $500,000 award will support the Company’s development of a novel, oral, broad-spectrum antiviral candidate for the treatment of influenza A and B infections. Cocrystal plans to utilize these funds to characterize lead candidate molecules that inhibit the target of the essential function of the influenza polymerase complex. The NIH/NIAID Phase I award is designed to assess the scientific, technical and commercial potential of early-stage programs. Successful completion of Phase I may qualify the recipient eligible to apply for a larger Phase II award, which provides additional substantial funding to continue development. The research is supported by the National Institute of Allergy and Infectious Diseases of the NIH under award number 75N93025C00038. The content of this news release is solely the responsibility of Cocrystal and does not necessarily represent the official views of the NIH. Announcement • Sep 16
Cocrystal Pharma, Inc. has completed a Follow-on Equity Offering. Cocrystal Pharma, Inc. has completed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 2,764,710
Price\Range: $1.7
Discount Per Security: $0.119
Security Name: Warrants
Security Type: Equity Warrant
Securities Offered: 5,529,420
Transaction Features: Registered Direct Offering Announcement • Sep 13
Cocrystal Pharma, Inc. has completed a Follow-on Equity Offering in the amount of $7.25 million. Cocrystal Pharma, Inc. has completed a Follow-on Equity Offering in the amount of $7.25 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 156,270
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 85,834
Transaction Features: At the Market Offering Announcement • Sep 09
Cocrystal Pharma, Inc. Receives Fda Ind Clearance for Challenge Study of Oral Broad-Spectrum Protease Inhibitor Cdi-988, A Potential First Antiviral for Norovirus Prevention and Treatment Cocrystal Pharma, Inc. announced that the Company received a Study May Proceed Letter from the U.S. Food and Drug Administration (FDA) to conduct a Phase 1b challenge study evaluating CDI-988 for the prevention and treatment of norovirus infections. Cocrystal's oral broad-spectrum antiviral candidate CDI-988 represents a potential breakthrough for norovirus - the most common cause of acute viral gastroenteritis. The Phase 1b challenge study is planned to begin before year-end 2025. CDI-988 is a novel pan-viral 3CL protease inhibitor developed for the treatment of norovirus and coronavirus infections. Preclinical data demonstrate that CDI-988 exhibits broad-spectrum antiviral activity by targeting a highly conserved region in the active site of the viral proteases. CDI-988 has shown effectiveness against major norovirus proteases including the prevalent GII.4 and GII.17. Data from the Phase 1 study showed oral CDI-988 to be well tolerated with a favorable safety profile. Currently, there are no approved vaccines or therapeutics for norovirus infections. Announcement • Aug 05
Cocrystal Pharma, Inc. Presents Phase 1 Results for Pan-Viral Inhibitor CDI-988 at Department of Defense Medical Conference Cocrystal Pharma, Inc. announced the presentation of favorable safety and tolerability data from a randomized, double-blinded, placebo-controlled Phase 1 study with its oral, direct-acting pan-viral inhibitor CDI-988 at the 2025 Military Health System Research Symposium (MHSRS), being held August 4-7 in Kissimmee, Florida. The results support Cocrystal's continued clinical development of CDI-988 as a potential norovirus prophylaxis and treatment. In An Oral Pan-viral Protease Inhibitor for the Prevention and Treatment of Norovirus and Coronavirus Infections: Mechanism of Action and Phase 1 Study Results, Sam Lee, Ph.D., Cocrystal President and co-CEO, discussed findings from the CDI-988 Phase 1 single-ascending (SAD) and multiple-ascending (MAD) cohorts. Data indicate that all doses, ranging from 100 mg to 1200 mg, were well tolerated. Overall treatment-emergent adverse events among CDI-988 subjects were 28% (10/36) compared with 40% (4/10) among placebo subjects for the SAD cohorts, and 53% (19/36) and 92% (11/12), respectively, for the MAD cohorts. Headache was the most common adverse event. All subjects in the SAD cohorts and all but one in the MAD cohorts completed the study. No severe treatment-emergent adverse event, no clinically relevant ECG changes and no clinically significant pathology results were reported from the CDI-9 88 Phase 1 single-ascending ("SAD") and multiple-ascending ("MAD) cohorts. "Consistent with interim results from the Phase 1 study, CDI-988 was well-tolerated with a favorable safety profile across all dose levels tested in this study," said Dr. Lee. "Our plan to continue CDI-988's clinical development for norovirus is particularly relevant for the military, where this highly transmissible pathogen purposes significant operational and economic risks. "Norovirus presents significant vaccine development challenges due to its high genetic variability and mutation rate. CDI-988's mechanism of action targeting viral replication and its broad-spectrum coverage offers a promising solution as a potential prophylactic and therapeutic intervention across all norovirus genog Groups including GII.4 and GII.17. This could be a new approach to outbreak prevention and management. The goal of this technology is to facilitate the development of novel broad-spectrum antivirals for the treatment of acute and chronic viral diseases. Announcement • Jul 10
Cocrystal Pharma, Inc. to Present Data from Phase 1 Study of First-In-Class Norovirus Protease Inhibitor CDI-988 at the 9th International Calicivirus Conference Cocrystal Pharma, Inc. announced that its first-in-class pan-viral protease inhibitor CDI-988 has been selected for an oral presentation at the 9th International Calicivirus Conference being held September 7-11, 2025 in Banff, Alberta, Canada. Sam Lee, PhD, the Company's President and co-CEO, will present "Oral Direct-Acting Antiviral CDI-988 for Norovirus Infection Prevention and Treatment: Mechanism of Action and Phase 1 Study Results" on September 11. This helps to identify novel binding sites and allows for a rapid turnaround of structural information through highly automated X-ray data processing and refinement. The goal of this technology is to facilitate the development of best-in-class antiviral therapies that have fast onset of action or shortened treatment time, are safe, well tolerated and easy to administer, and are effective against all viral subtypes that cause disease and have a high barrier to viral resistance. Announcement • Jun 05
Cocrystal Pharma's Novel Norovirus Antiviral to Be Presented at Department of Defense Medical Conference Cocrystal Pharma, Inc. announced that its broad-spectrum protease inhibitor CDI-988 will be featured in an oral presentation at the 2025 Military Health System Research Symposium (MHSRS) being held August 4-7 in Kissimmee, Fla. Cocrystal is developing CDI-988 as a norovirus prophylaxis and treatment. Sam Lee, PhD, the Company's President and co-CEO, will discuss Phase 1 results during the Broad-Spectrum Anti-Viral Countermeasures breakout session on August 4, 2025. This helps to identify novel binding sites and allows for a rapid turnaround of structural information through highly automated X-ray data processing and refinement. The goal of this technology is to facilitate the development of best-in-class antiviral therapies that have fast onset of action or shortened treatment time, are safe, well tolerated and easy to administer; and are effective against all viral subtypes that cause disease and have a high barrier to viral resistance. Announcement • May 29
Cocrystal Pharma, Inc.'S Investigational Drug Candidate Cc-42344 Demonstrates Strong Antiviral Potency Against the 2024 Highly Pathogenic H5n1 Avian Influenza Strain Cocrystal Pharma, Inc. announced that a recent virology study showed its novel, broad-spectrum influenza PB2 inhibitor CC-42344 exhibits strong antiviral activity against the highly pathogenic H5N1 avian influenza A strain (A/Texas/37/2024). On March 25, 2024, the highly pathogenic avian H5N1 influenza virus was confirmed in a dairy cow in Texas and has continued to spread widely in U.S. dairy cattle, causing a few human cases. There is concern that the H5N1 virus could adapt for human-to-human transmission and potentially result in an influenza pandemic. The virology study utilized the highly pathogenic H5 N1 avian strain (influenza A/Texas/37/2024) and was conducted to test antiviral activity of CC-42344 using Tamiflu®? as a reference inhibitor. The data showed that CC-42344 was highly potent against the H5N1 avian virus (EC50, 0.003 uM), approximately 1,000-fold more potent, compared to a refence compound Tamiflu (EC50, 2.69 uM). CC-42344 is currently in development as an oral treatment for pandemic avian and seasonal influenza A infections with initial data showing a favorable safety and tolerability profile. Announcement • Apr 28
Cocrystal Pharma, Inc., Annual General Meeting, Jun 25, 2025 Cocrystal Pharma, Inc., Annual General Meeting, Jun 25, 2025. Announcement • Apr 25
Cocrystal Pharma, Inc.'S Norovirus Oral Antiviral Candidate Demonstrates Potent Activity Against the Emerging GII.17 Variants Cocrystal Pharma, Inc. announced that its investigative drug candidate CDI-988 was shown to bind to the highly conserved region of the GII.17 protease with excellent potency, similar to that shown across a range of GII.4 norovirus variants that had been the dominant worldwide strains until this year. The high resolution GII.17 protease crystal structures used in determining CDI-988's activity were obtained using the Company's proprietary structure-based platform technology. Cocrystal plans to initiate a human norovirus challenge study in 2025 in the U.S. to evaluate CDI-988 as a potential prevention and treatment of norovirus infection. Norovirus antiviral and vaccine development has been extremely challenging due to high diversity among variants that include 10 genog Groups and 49 genotypes. This helps to identify novel binding sites and allows for a rapid turnaround of structural information through highly automated X-ray data processing and refinement. The goal of this technology is to facilitate the development of best-in-class antiviral therapies that have fast onset of action and/or shortened treatment time, are safe, well tolerated and easy to administer, are effective against all viral subtypes that cause disease and have a high barrier to viral resistance. Announcement • Jan 09
Cocrystal Pharma Reports Phase 1 Results with Oral, Broad-Acting Antiviral Drug Cdi-988 for Prophylaxis and Treatment of Norovirus, Coronaviruses and Other Viral Infections Cocrystal Pharma, Inc. announces favorable safety and tolerability results at dosing up to 800 mg per day for 10 consecutive days from the multiple-ascending dose (MAD) portion of the ongoing Phase 1 study with its oral protease inhibitor CDI-988, the first pan-viral drug candidate in development as an orally administered treatment of norovirus and coronavirus infections. The Company also announces that an additional cohort with a higher dose of 1,200 mg and a shorter treatment duration of five consecutive days will be conducted to further assess CDI-988’s safety, tolerability and pharmacokinetics. CDI-988 is a potent, oral, broad-spectrum antiviral inhibitor of a highly conserved region in the active site of noroviruses, coronaviruses and other 3CL viral proteases. It was specifically designed and developed using Cocrystal’s proprietary structure-based drug discovery platform technology. CDI-988 has shown pan-viral activity against multiple norovirus strains, including the genogroup II, genotype 4 (GII.4) viruses that cause severe vomiting, diarrhea and stomach pain. Human noroviruses are highly contagious, constantly evolving, extremely stable in the environment and associated with debilitating illness. Outbreaks occur most commonly in semi-closed communities such as nursing homes, hospitals, cruise ships, schools, disaster relief sites and military settings. Symptoms include vomiting and diarrhea, with or without nausea and abdominal cramps. Norovirus infection can be much more severe and prolonged in specific risk groups including infants, children, the elderly and people with immunodeficiency.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 approximately $60 billion. In the U.S. alone, noroviruses are responsible for an estimated 21 million cases of acute gastroenteritis annually, including 109,000 hospitalizations, 465,000 emergency department visits and nearly 900 deaths. The estimated annual burden of noroviruses to the U.S. is $10.6 billion, according to the National Institutes of Health (NIH). Announcement • Jan 01
Cocrystal Pharma, Inc. to Extend Phase 2a Influenza Challenge Study with Oral PB2 Inhibitor CC-42344 Cocrystal Pharma, Inc. announced plans to extend enrollment in the Phase 2a human challenge study with its investigational, broad-spectrum, oral influenza PB2 inhibitor CDI-42344 due to unexpectedly low influenza infection among study participants who were challenged with a H3N2 viral strain. This randomized, double-blind, placebo-controlled Phase 2a study is evaluating the safety, tolerability, pharmacokinetics (PK), antiviral activity and clinical measurements of CC-42344 at a single site in the United Kingdom. CC-42344 is a drug candidate in development as an oral treatment for pandemic avian and seasonal influenza A infections. In December 2023, Cocrystal Pharma announced enrollment of the first patient in this study and in May 2024, the Company announced full enrollment of 78 subjects. New Risk • Nov 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$14m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$14m free cash flow). Share price has been highly volatile over the past 3 months (13% average weekly change). Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$26m net loss in 2 years). Market cap is less than US$100m (€21.3m market cap, or US$22.4m). Announcement • Jul 18
Cocrystal Pharma, Inc. Reports Favorable Results from Single-Ascending Dose Cohorts of Phase 1 Study with CDI-988, its Oral Pan-Viral Norovirus/Coronavirus Protease Inhibitor Cocrystal Pharma, Inc. reported favorable safety and tolerability results from the single-ascending dose (SAD) cohorts of the Phase 1 study in healthy volunteers with CDI-988, its potent, oral, pan-viral protease inhibitor. CDI-988 was specifically designed and developed using Cocrystal’s proprietary structure-based drug discovery platform technology as a broad-spectrum antiviral inhibitor to a highly conserved region in the active site of 3CL viral proteases. It is being developed as the first dual, broad-spectrum antiviral for the treatment of norovirus and coronaviruses. The single-center, randomized, double-blind Phase 1 study is evaluating the safety, tolerability and pharmacokinetics including a food-effect cohort of orally administered CDI-988 compared with placebo in healthy adults and is being conducted in Australia. Study participants in the SAD cohorts received CDI-988 in doses ranging from 100 mg to 600 mg. All participants completed the study with no discontinuations. There were no serious adverse events or severe treatment-emergent adverse events. No clinically significant observations were noted in laboratory assessments, physical exams or electrocardiograms. Announcement • Jun 20
Cocrystal Pharma Advances Cc-42344 in Influenza A Phase 2A Study, Expects Topline Results by Late 2024 Cocrystal Pharma, Inc. 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 is conducting an influenza A Phase 2a clinical study with orally administered CC-42344 and expects to report topline results in the second half of 2024. This study is evaluating the safety, tolerability, antiviral and clinical benefits in influenza A infected subjects. In late 2022 Cocrystal reported favorable safety and tolerability results from a Phase 1 study in healthy volunteers. 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. 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. 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. Announcement • May 01
Cocrystal Pharma, Inc. Announces Completion of Enrollment of 78 Subjects Cocrystal Pharma, Inc. announced 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 andcription 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. 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 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 potentially 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. 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 influenzaA. The randomized, double-blind, randomized, double-blind, administered study was designed to evaluate the safety, tolerability, viral and clinical measurements of influenza A infection in subjects dosed with oral CC-42344 treatment. In addition to the health risk, influenza is responsible for approximately $10.4 billion in direct costs for hospitalizations and outpatient visits for adults in the U.S. annually. New Risk • Apr 08
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 6.9% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 2.0% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$19m net loss in 2 years). Share price has been volatile over the past 3 months (6.9% average weekly change). Shareholders have been diluted in the past year (25% increase in shares outstanding). Market cap is less than US$100m (€14.9m market cap, or US$16.2m). New Risk • Apr 04
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 2.0% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 2.0% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$19m net loss in 2 years). Shareholders have been diluted in the past year (25% increase in shares outstanding). Market cap is less than US$100m (€13.4m market cap, or US$14.6m). Announcement • Jan 05
Cocrystal Pharma, Inc. Provides an Update on the Clinical Development of its Novel, Broad-Spectrum Antiviral Investment Candidates Cocrystal Pharma, Inc. 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 Cocrystal's unique structure-based drug discovery technology platform to be effective on a broad range of viruses causing these diseases. 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. 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. Announcement • Dec 06
Cocrystal Pharma, Inc. Announces First-Patient-In for Phase 2A Human Challenge Study Evaluating Oral Cc-42344 in Pandemic and Seasonal Influenza A Cocrystal Pharma, Inc. 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. Announcement • Nov 30
Cocrystal Pharma, Inc. Highlights Its Novel Inhaled and Oral Influenza A Antiviral Cc-42344 At the World Vaccine Congress West Coast Cocrystal Pharma, Inc. announced 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. Announcement • Sep 29
Cocrystal Pharma, Inc. Doses First Subjects in Clinical Study of CDI-988 for Pandemic Norovirus and Coronavirus Cocrystal Pharma, Inc. announced dosing of the first subjects in a Phase 1 clinical trial with its oral, first-in-class pan-norovirus and pan-coronavirus 3CL protease inhibitor CDI-988. This pan-viral protease inhibitor was discovered using the Company's proprietary structure-based drug discovery platform technology. The Phase 1 study will evaluate the safety, tolerability and pharmacokinetics of oral CDI-988 in single ascending doses (SAD) including food effect cohort, and multiple ascending doses (MAD) compared to placebo in healthy volunteers. Recent CDI-988 in vitro studies showed potent broad-spectrum antiviral activity against a panel of pandemic GII.4 norovirus proteases and a favorable pharmacokinetic property targeting the gastrointestinal tract. GII.4 proteases have caused the majority of norovirus outbreaks worldwide since 2002. CDI-988 was specifically designed and developed as a broad-spectrum antiviral inhibitor using Cocrystal's proprietary structure-based Drug discovery platform technology. It targets a highly conserved region in the active site of noroviruses, noroviruses and other 3CL viral proteases. Cocrystal is approved to conduct a CDI-988 Phase 1 study in Australia by that country's Human Research Ethics Committee (HREC). New Risk • Aug 11
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 9.5% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (9.5% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$15m net loss in 2 years). Shareholders have been diluted in the past year (25% increase in shares outstanding). Market cap is less than US$100m (€27.4m market cap, or US$30.0m). New Risk • Jun 27
New major risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$15m net loss in 2 years). Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (25% increase in shares outstanding). Market cap is less than US$100m (€23.1m market cap, or US$25.3m). Announcement • Dec 20
Cocrystal Pharma Reports Highly Favorable Safety and Tolerability Results from a Phase 1 Study with its Oral Antiviral CC-42344 for the Treatment of Pandemic and Seasonal Influenza A Cocrystal Pharma, Inc. announces highly favorable safety and tolerability results for its orally administered replication inhibitor CC-42344 in its Phase 1 study. CC-42344 is a broad-spectrum antiviral for the treatment of pandemic and seasonal influenza A with a novel mechanism of action. The randomized, double-controlled Phase 1 study was conducted in Australia to evaluate the safety, tolerability and pharmacokinetics (PK) of CC-42344 given orally at single doses up to 800 mg and daily doses up to 14 days in 56 healthy volunteers. Approximately 50% of the participants who received a single dose of CC-42344 across all dose levels (100 to 800 mg) experienced adverse events, similar to the proportion of placebo subjects who also experienced adverse events. In the multiple-dose section of the study, the incidence of adverse events was 67% for both CC-42344 (50 to 200 mg) and placebo. The vast majority of adverse events were mild in severity. The most frequently reported adverse event was headache, which occurred at similar rates in CC-42344-treated and placebo-treated participants. There were no serious adverse events or drug discontinuation due to adverse events. Cocrystal plans to apply to the United Kingdom Medicines and Healthcare Products Regulatory Agency to conduct a Phase 2a human challenge study in early 2023. Subject to regulatory clearance, the study is expected to be initiated in the second half of 2023. CC-42344 is an oral PB2 inhibitor 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 conserved 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 Tamiflu® and Xofluza®, while also demonstrating favorable PK and safety profiles. Announcement • Nov 18
Cocrystal Pharma, Inc. Announces Favorable Safety Data from the Phase 1 Study with Oral Antiviral CC-42344 for the Treatment of Pandemic and Seasonal Influenza A Cocrystal Pharma, Inc. announced that CC-42344 demonstrated a favorable safety profile in both the single-ascending dose and the multiple-ascending dose portions of the ongoing Phase 1 study. CC-42344 is a broad-spectrum oral antiviral for the treatment of pandemic and seasonal influenza A with a novel mechanism of action. The randomized, double-controlled, dose-escalating Phase 1 study in Australia was designed to assess the safety, tolerability and pharmacokinetics (PK) of orally administered CC-42344 in healthy adults. In July 2022 Cocrystal reported that PK data from the single-ascending dose portion of the study support once-daily dosing. In October 2022 enrollment in the multiple-ascending dose portion of the trial was completed. The Company plans to present topline study results at the upcoming World Antiviral Congress on December 1, 2022 and to submit an application with the United Kingdom Medicines and Healthcare Products Regulatory Agency to conduct a Phase 2a human challenge study in early 2023. Subject to regulatory agency clearance, the Phase 2a study is expected to be initiated in the second half of 2023.