Release – Cocrystal Pharma, Inc. Announces Closing of Up To $13 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules

September 15, 2025

$4.7 million upfront with up to an additional approximately $8.3 million of potential aggregate gross proceeds upon the exercise in full of warrants

BOTHELL, Wash., Sept. 15, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc., (Nasdaq: COCP) (the “Company” or “Cocrystal”), today announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules for the purchase and sale of 2,764,710 shares of its common stock at a purchase price of $1.70 per share. In a concurrent private placement, the Company issued unregistered warrants to purchase up to 5,529,420 shares of common stock at an exercise price of $1.50 per share that are exercisable upon issuance and will expire twenty-four months from the effective date of the registration statement covering the resale of the shares of common stock issuable upon exercise of the unregistered warrants.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering, before deducting the placement agent’s fees and other offering expenses payable by the Company, were approximately $4.7 million. The potential additional gross proceeds to the Company from the warrants, if fully-exercised on a cash basis, will be approximately $8.3 million. No assurance can be given that any of such short-term warrants will be exercised. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

The common stock (but not the unregistered warrants and the shares of common stock underlying the unregistered warrants) described above were offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-271883) that was declared effective by the Securities and Exchange Commission (the “SEC”) on May 26, 2023. The offering of the shares of common stock was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering were filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.

The unregistered warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company that addresses significant unmet needs by developing innovative antiviral treatments for challenging diseases including influenza, viral gastroenteritis, COVID, and hepatitis. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs.

Forward-Looking Statements

The information in this press release includes “forward-looking statements.” Any statements other than statements of historical fact contained herein, including statements as to the intended use of net proceeds from the offering, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “could”, “might”, “plan”, “possible”, “project”, “strive”, “budget”, “forecast”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology.

Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com

Release – Cocrystal Pharma, Inc. Announces Up To $13 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules

Research News and Market Data on COCP

September 12, 2025

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$4.7 million upfront with up to an additional approximately $8.3 million of potential aggregate gross proceeds upon the exercise in full of warrants

BOTHELL, Wash., Sept. 12, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc., (Nasdaq: COCP) (the “Company” or “Cocrystal”), today announced that it has entered into definitive agreements for the purchase and sale of 2,764,710 shares of its common stock (or common stock equivalents in lieu thereof) at a purchase price of $1.70 per share in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, the Company will issue unregistered warrants to purchase up to 5,529,420 shares of common stock at an exercise price of $1.50 per share that will be exercisable upon issuance and will expire twenty-four months from the effective date of the registration statement covering the resale of the shares of common stock issuable upon exercise of the unregistered warrants. The closing of the offering is expected to occur on or about September 15, 2025, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering, before deducting the placement agent’s fees and other offering expenses payable by the Company, are expected to be approximately $4.7 million. The potential additional gross proceeds to the Company from the warrants, if fully-exercised on a cash basis, will be approximately $8.3 million. No assurance can be given that any of such short-term warrants will be exercised. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

The common stock (or common stock equivalents in lieu thereof, but not the unregistered warrants and the shares of common stock underlying the unregistered warrants) described above are being offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-271883) that was declared effective by the Securities and Exchange Commission (the “SEC”) on May 26, 2023. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.

The unregistered warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company that addresses significant unmet needs by developing innovative antiviral treatments for challenging diseases including influenza, viral gastroenteritis, COVID, and hepatitis. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs.

Forward-Looking Statements

The information in this press release includes “forward-looking statements.” Any statements other than statements of historical fact contained herein, including statements as to the completion of the offering, the satisfaction of customary closing conditions related to the offering and the intended use of net proceeds from the offering, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “could”, “might”, “plan”, “possible”, “project”, “strive”, “budget”, “forecast”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology.

Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com

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Source: Cocrystal Pharma, Inc.

Released September 12, 2025

Release – Cocrystal Pharma Showcases CDI-988, the First Oral Antiviral in Development for Norovirus Infection, in a Podium Presentation at the International Calicivirus Conference

Research News and Market Data on COCP

September 12, 2025

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BOTHELL, Wash., Sept. 12, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that President and co-CEO Sam Lee, PhD discussed the scientific foundation and clinical progress with the Company’s lead pan-viral protease inhibitor CDI-988 during a podium presentation at the 9th International Calicivirus Conference, held September 7–11, 2025 in Banff, Alberta. Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 represents a potential first oral antiviral for the prevention and treatment of norovirus infection.

“It was an honor to share highlights of our CDI-988 Phase 1 data with global norovirus experts at the leading calicivirus scientific meeting,” said Dr. Lee. “The recent completion of Phase 1 study and U.S. Food and Drug Administration’s (FDA) Investigation New Drug (IND) clearance for the next study mark significant milestones for our clinical development of CDI-988.”

In Oral Direct-Acting Antiviral CDI-988 for Norovirus Infection Prevention and Treatment: Mechanism of Action and Phase 1 Study Results,” Dr. Lee emphasized CDI-988’s favorable safety profile in human intestinal tissue, the primary site of norovirus infection, along with its high exposure in small intestine, suggesting a potential GI-targeted norovirus antiviral.

CDI-988 was rationally designed with Cocrystal’s proprietary structure-based drug discovery platform technology. In vitro potency data and high-resolution crystal structures have shown broad-spectrum antiviral activity against multiple norovirus genogroups including GII.4 and GII.17, the strain responsible for the majority of circulating infections.

Dr. Lee also discussed previously reported Phase 1 results demonstrating CDI-988’s favorable safety and tolerability profile, with no serious adverse events. Earlier this week, Cocrystal announced FDA authorization to proceed with a Phase 1b human challenge study to evaluate CDI-988 as a potential norovirus prophylaxis and treatment. The study is expected to begin before year end.

The Calicivirus Conference is held every three years and unites scientists from across the globe who study calicivirus virology, evolution, pathogenesis, structural biology, diagnosis, epidemiology, treatment and prevention. The conference aims to foster open discussions, spark new collaborations and explore groundbreaking research. Delegates at this year’s conference engaged with the latest advances in the field through state-of-the-art lectures, oral presentations and poster sessions.

Protease Inhibitor CDI-988
CDI-988 was designed and developed with Cocrystal’s proprietary structure-based platform technology as a broad-spectrum inhibitor to a highly conserved region in the active site of 3CL viral proteases. It targets a highly conserved region in the active site of noroviruses, coronaviruses and other 3CL viral proteases.

Norovirus Infection
Norovirus, the leading cause of viral gastroenteritis worldwide, spreads rapidly in community settings such as hospitals, nursing homes, childcare facilities, schools and cruise ships. It causes nausea, vomiting, diarrhea, abdominal pain and dehydration, and is responsible for an estimated $60 billion worldwide in direct healthcare costs and lost productivity.

Cocrystal Structure-Based Platform Technology
CDI-988 leverages Cocrystal’s proprietary structure-based drug discovery platform, which provides three-dimensional visualization of inhibitor complexes at near-atomic resolution. This technology enables rapid identification of novel drug binding sites and accelerates the development of broad-spectrum antivirals for the treatment of acute and chronic viral diseases.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company that addresses significant unmet needs by developing innovative antiviral treatments for challenging diseases including influenza, viral gastroenteritis, COVID, and hepatitis. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs.

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 CDI-988 as a potential antiviral for the prevention and treatment of norovirus infection, and the Company’s plan to initiate a Phase 1b study in 2025. 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, the risks and uncertainties arising from the ability of our clinical research organization to recruit volunteers for, and to otherwise proceed with the challenge study, our contract manufacturing organization’s ability to produce the products needed for the study, risks relating to our ability to obtain regulatory approval for and proceed with clinical trials and our liquidity needs. 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, 2024. 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.

Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com

# # #

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Source: Cocrystal Pharma, Inc.

Released September 12, 2025

Release – Cocrystal Pharma Receives FDA IND Clearance for Challenge Study of Oral Broad-Spectrum Protease Inhibitor CDI-988, a Potential First Antiviral for Norovirus Prevention and Treatment

Research News and Market Data on COCP

September 08, 2025

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  • There are currently no approved vaccines or treatments for norovirus infection
  • Cocrystal’s CDI-988 is the first antiviral for the potential prevention and treatment of viral gastroenteritis caused by norovirus infections
  • Phase 1b study is expected to start by year-end 2025

BOTHELL, Wash., Sept. 08, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces 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.

“The FDA’s clearance of our CDI-988 study is an important milestone for Cocrystal and marks a significant step in advancing to the next stage of its clinical development. CDI-988 is the first novel, oral drug candidate for the prevention and treatment for norovirus infection and has demonstrated impressive data to date with broad antiviral activity,” said Sam Lee, PhD, President and co-CEO of Cocrystal Pharma. “We look forward to the planned initiation of our Phase 1b challenge study and further determining the potential efficacy of CDI-988 in norovirus-infected patients.”

About Norovirus
Norovirus infections affect millions globally, spreading rapidly through direct contact and contaminated food and surfaces. The virus is particularly problematic in confined environments such as cruise ships, hospitals, and military facilities. In the U.S., norovirus causes an estimated 21 million infections annually, including 109,000 hospitalizations, 465,000 emergency department visits and an estimated 900 deaths. Vulnerable populations, including infants, elderly and those immuno-compromised, can face more severe and prolonged infections. Individuals can remain contagious for weeks after symptoms are resolved, complicating containment efforts.

Cocrystal Structure-Based Platform Technology
CDI-988 leverages Cocrystal’s proprietary structure-based drug discovery platform, which provides three-dimensional visualization of inhibitor complexes at near-atomic resolution. This technology enables rapid identification of novel drug binding sites and accelerates the development of broad-spectrum antivirals for the treatment of acute and chronic viral diseases.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company that addresses significant unmet needs by developing innovative antiviral treatments for challenging diseases including influenza, viral gastroenteritis, COVID, and hepatitis. Cocrystal employs unique structure-based technologies to create first- and best-in-class antiviral drugs.

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 to initiate a human Phase 1b challenge study for our norovirus 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, the risks and uncertainties arising from the ability of our clinical research organization to recruit volunteers for, and to otherwise proceed with the challenge study, our contract manufacturing organization’s ability to produce the products needed for the study, geopolitical conflicts including those in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., economy, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials for and otherwise proceed with the study, and our ability to meet our liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024. 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.

Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com

# # #

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Source: Cocrystal Pharma, Inc.

Released September 8, 2025

Cocrystal Pharma (COCP) – 2Q25 Reported With Norovirus and Influenza Product Updates


Friday, August 15, 2025

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.

Antivirals Continue To Move Forward. Cocrystal reported 2Q25 loss of $2.1 million or $(0.20) per share. During 2Q, the company presented data from its CDI-988 Phase 1 study in norovirus. Separately, CDI-988 has demonstrated inhibition of multiple strains, including GII.17 and GII.4 that have caused norovirus outbreaks over the past 2 years. The Phase 2a human challenge study testing CC-42344 in influenza has been extended. CC-42344 has shown inhibition of several strains of avian influenza that have caused public health concerns. Cash on June 30, 2025 was $4.8 million.

Phase 1b Is Planned For CDI-988  In Norovirus. Data from a Phase 1 trial showing safety and efficacy of CDI-988 was presented in August. The data show that CDI-988 was safe and effective through a range of doses in a single-ascending (SAD) and multiple-ascending (MAD) dose cohorts. A Phase 1b study testing CDI-988 as both treatment and prophylaxis for norovirus is planned for later in FY2025.


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Release – Cocrystal Pharma Reports Second Quarter 2025 Financial Results and Provides Updates on its Antiviral Drug-Development Programs

Research News and Market Data on COCP

August 14, 2025

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  • Favorable CDI-988 Phase 1 safety and tolerability reported
  • Challenge study with CDI-988 as a norovirus preventive and treatment planned later this year

BOTHELL, Wash., Aug. 14, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the three and six months ended June 30, 2025, and provides updates on its antiviral product pipeline, upcoming milestones and business activities.

“Preparations are underway for a Phase 1b norovirus challenge study to evaluate our potent, oral antiviral candidate CDI-988 as a prophylaxis and treatment,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “We are encouraged by the favorable safety and tolerability results from our Phase 1 study with CDI-988. This novel protease inhibitor has the potential to transform how we manage this highly contagious virus, which spreads rapidly in military facilities, cruise ships, nursing homes, hospitals and other confined environments. As a prophylactic treatment, CDI-988 could potentially prevent rapid spread of norovirus outbreaks in close quarters.

“We developed CDI-988 for the treatment of norovirus and coronavirus infections using our proprietary structure-based drug discovery platform technology. We are encouraged by our recent in vitro data demonstrating CDI-988 inhibits newly re-emerging norovirus GII.17 strains that are responsible for the 2024-2025 norovirus outbreaks,” added Dr. Lee.

“The absence of any approved norovirus treatments or vaccines creates a substantial market opportunity for Cocrystal,” said James Martin, Cocrystal’s CFO and co-CEO. “With 685 million global cases annually and a $60 billion worldwide economic impact, norovirus represents one of healthcare’s most pressing unmet needs.”

Antiviral Product Pipeline Overview

We harness our revolutionary, structure-based drug discovery platform technology to engineer next-generation, broad-spectrum antivirals that precisely disrupt viral replication mechanisms. Unlike traditional approaches, our technology identifies compounds that bind to highly conserved regions of viral enzymes, thereby creating a formidable defense against current viral threats as well as their mutations. By specifically targeting these evolutionary-constrained viral regions, our drug candidates maintain efficacy even as viruses mutate, while simultaneously minimizing off-target interactions that typically lead to adverse side effects. This dual advantage represents a significant breakthrough in antiviral drug development. In addition, our innovative methodology fundamentally transforms the conventional drug discovery paradigm by eliminating the inefficient, resource-intensive cycles of high-throughput compound screening and prolonged hit-to-lead optimization. The result is faster identification of promising candidates with superior resistance profiles and safety characteristics.

Influenza Programs
Influenza is a major global health threat that may become more challenging to treat due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Currently approved antiviral treatments for influenza are effective but are burdened with significant viral resistance.

Each year there are approximately 1 billion cases of seasonal influenza worldwide, 3-5 million severe illnesses and up to 650,000 deathsAbout 8 percent of the U.S. population gets sick from flu each season. In addition to the health risk, influenza is responsible for an estimated $10.4 billion in direct medical costs in the U.S. each year.

  • Oral CC-42344 for the treatment of pandemic and seasonal influenza A
    • Our novel PB2 inhibitor CC-42344 showed excellent in vitro activity against pandemic and seasonal influenza A strains, as well as strains that are resistant to Tamiflu® and Xofluza®.
    • In December 2022 we reported favorable safety and tolerability results from the CC-42344 Phase 1 study.
    • In December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, viral and clinical measurements of CC-42344 in influenza A-infected subjects in the United Kingdom, following authorization from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
    • In May 2024 we completed enrollment in the Phase 2a human challenge study.
    • In June 2024 we reported that in vitro studies demonstrated CC-42344 inhibits the activity of the highly pathogenic avian influenza A (H5N1) PB2 protein identified in humans exposed to infected dairy cows.
    • In December 2024 we announced a plan to extend the CC-42344 Phase 2a human challenge study due to unexpectedly low influenza infection among study participants.
    • In May 2025 we reported that CC-42344 was shown to be active against the highly pathogenic 2024 Texas H5N1 avian influenza strain.
  • Inhaled CC-42344 as prophylaxis and treatment for pandemic and seasonal influenza A
    • Our preclinical testing showed superior pulmonary pharmacology with CC-42344, including high exposure to drug and a long half-life.
    • Dry powder inhalation formulation development and toxicology studies have been completed.
  • Influenza A/B program
    • Our efforts to develop a preclinical lead of novel influenza replication inhibitors for pandemic and season influenza are ongoing.

Norovirus Program
Norovirus is a common and highly contagious virus that afflicts people of all ages and causes symptoms of acute gastroenteritis including nausea, vomiting, stomach pain and diarrhea, as well as fatigue, fever and dehydration. There is currently no effective treatment or effective vaccine for norovirus, and the ability to curtail outbreaks is limited.

In the U.S., noroviruses are responsible for an estimated 21 million infections annually, including 109,000 hospitalizations, 465,000 emergency department visits and an estimated 900 deaths. The annual burden of norovirus to the U.S. is estimated at $10.6 billion. Noroviruses are responsible for up to 1.1 million hospitalizations and 218,000 deaths annually in children in the developing world.

  • Oral pan-viral protease inhibitor CDI-988 for the treatment of noroviruses and coronaviruses
    • Our novel, broad-spectrum protease inhibitor CDI-988 is being evaluated as a potential treatment for noroviruses and coronaviruses.
    • CDI-988 has shown in vitro pan-viral activity against multiple norovirus strains.
    • 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 pharmacokinetics (PK) of CDI-988 in healthy subjects.
    • In August 2023 we announced our selection of CDI-988 as our lead compound for the treatment for noroviruses, in addition to coronaviruses.
    • In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study.
    • In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a high-dose cohort.
    • In April 2025 we announced that CDI-988 showed superior broad-spectrum antiviral activity against GII.17 strains, the most prevalent strain in the U.S. and Europe in 2024-2025.
    • In August 2025 we presented favorable safety and tolerability Phase 1 data from all CDI-988 doses, including the high-dose 1200 mg cohort, at the 2025 Military Health System Research Symposium (MHSRS).
    • We plan to initiate a human challenge Phase 1b study in the U.S. in 2025 to evaluate CDI-988 as a norovirus prophylaxis and treatment.

SARS-CoV-2 and Other Coronavirus Program
By targeting viral replication enzymes and proteases, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including SARS-CoV-2 and its variants, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). CDI-988 showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses, as well as against noroviruses. The global COVID-19 therapeutics market is estimated to exceed $16 billion annually by the end of 2031.

  • Oral pan-viral protease inhibitor CDI-988 for the treatment of coronaviruses and noroviruses
    • CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and demonstrated a favorable safety profile and PK properties.
    • In September 2023 we dosed the first healthy subject in our norovirus/coronavirus CDI-988 study, which is expected to serve as a Phase 1 study for both indications.
    • In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study.
    • In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a high-dose cohort.
    • In August 2025 we presented favorable safety and tolerability Phase 1 data from all CDI-988 doses, including the high-dose 1200 mg cohort, at the MHSRS.

Second Quarter Financial Results

Research and development (R&D) expenses for the second quarter of 2025 were $1.1 million, compared with $4.3 million for the second quarter of 2024, with the decrease primarily due to the timing of clinical study costs. General and administrative (G&A) expenses for the second quarter of 2025 were $1.0 million, compared with $1.1 million for the second quarter of 2024, with the decrease primarily due to a reduction in salaries and wages.

Net loss for the second quarter of 2025 was $2.1 million, or $0.20 per share, compared with net loss for the second quarter of 2024 of $5.3 million, or $0.53 per share.  

Six Months Financial Results

R&D expenses for the first six months of 2025 were $2.5 million, compared with $7.3 million for the first six months of 2024. G&A expenses for the first half of 2025 were $2.0 million, compared with $2.3 million for the first half of 2024.

Net loss for the first six months of 2025 was $4.4 million, or $0.43 per share, compared with a net loss for the first six months of 2024 of $9.3 million, or $0.91 per share.

Cocrystal reported unrestricted cash as of June 30, 2025 of $4.8 million, compared with $9.9 million as of December 31, 2024. Net cash used in operating activities for the first six months of 2025 was $5.1 million, compared with $8.2 million for the first six months of 2024. The Company had working capital of $4.9 million and 10.2 million common shares outstanding as of June 30, 2025.  

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 viable 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 product candidates including the potential of our norovirus product candidate, our plans to initiate a human Phase 1b challenge study for our norovirus product candidate, and our plans with regard to initiating a second human challenge study for CC-42344. 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 our need for additional capital to fund our operations over the next 12 months, inflation, the possibility of a recession, interest rate increases, imposed and threated tariffs, and geopolitical conflicts including those 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 including any adverse impacts on our ability to obtain raw materials for and otherwise 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 progress and results of the studies including any adverse findings or delays, the ability of us and our CROs to recruit volunteers for, and to otherwise 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 any adverse developments which may arise therefrom, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the potential for the development of effective treatments by competitors which could reduce or eliminate a prospective future market share commercializing any product candidates we may develop in the future, and our ability to meet our future liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024. 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.

Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com

View full release here.

Release – Cocrystal Pharma Presents Phase 1 Results for Pan-Viral Inhibitor CDI-988 at Department of Defense Medical Conference

Research News and Market Data on COCP

August 05, 2025

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  • All CDI-988 doses, ranging from 100 mg to 1200 mg, in the Phase 1 study were well tolerated
  • Company expects to initiate Phase 1b study with CDI-988 in norovirus-infected healthy subjects later this year
  • Lack of approved norovirus treatments or vaccines creates critical unmet medical need

BOTHELL, Wash., Aug. 05, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces 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 events, no clinically relevant ECG changes and no clinically significant pathology results were reported from the CDI-988 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 poses significant operational and economic risks. In confined settings such as naval vessels and military installations, norovirus can rapidly spread, causing debilitating gastrointestinal symptoms that could compromise mission readiness.

“The absence of approved norovirus treatments or vaccines creates a critical unmet medical need,” he added. “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 genogroups including GII.4 and GII.17. This could be a new approach to outbreak prevention and management. We expect to initiate a Phase 1b challenge study with CDI-988 in norovirus-infected healthy subjects later this year.”

MHSRS is an annual educational symposium with approximately 4,000 attendees that provides a collaborative environment for military medical care providers with deployment experience, research and academic scientists, international partners and industry on research and related healthcare initiatives falling under the topic areas of combat casualty care, military operational medicine, clinical and rehabilitative medicine, information sciences, military infectious diseases and radiation health effects. More information is available here.

Pan-viral Protease Inhibitor CDI-988
CDI-988 was designed and developed with Cocrystal’s proprietary structure-based platform technology as a broad-spectrum inhibitor to a highly conserved region in the active site of 3CL viral proteases. Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 represents a compelling first potential oral treatment for noroviruses, and for coronaviruses.

Norovirus Infection
Norovirus is a common and highly contagious virus that afflicts people of all ages and causes symptoms of acute gastroenteritis including nausea, vomiting, stomach pain and diarrhea, as well as fatigue, fever and dehydration. Norovirus outbreaks occur most commonly in semi-closed communities such as hospitals, nursing homes, childcare facilities, cruise ships, schools and disaster relief sites. Norovirus infections are estimated to cost society approximately $60 billion annually worldwide.

Structure-Based Drug Discovery Platform Technology
Cocrystal’s proprietary structural biology, along with its expertise in enzymology and medicinal chemistry, enable its development of novel antiviral agents. The Company’s platform provides a three-dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide Structure Activity Relationships. 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 novel broad-spectrum antivirals for the treatment of acute and chronic viral diseases.

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 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 CDI-988 as a potential breakthrough for norovirus prophylaxis and treatment, and the potential characteristics of and market for such product candidate and the Company’s plan to initiate a Phase 1b study in 2025. 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, our need for additional capital to fund our operations over the next 12 months, risks relating to our ability to obtain regulatory approval 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, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the impact of the Trump Administration’s policies and actions on regulation affecting the FDA and other healthcare agencies and potential staffing issues resulting therefrom, as well as other government actions such as tariffs which may cause delays or force us to incur additional costs to proceed without development programs. 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, 2024. 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.

Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com

# # #

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Source: Cocrystal Pharma, Inc.

Released August 5, 2025

Release – Cocrystal Pharma to Present Data from Phase 1 Study of First-in-Class Norovirus Protease Inhibitor CDI-988 at the 9th International Calicivirus Conference

Research News and Market Data on COCP

July 10, 2025

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BOTHELL, Wash., July 10, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces 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 year’s Calicivirus Conference will bring together the world’s leading norovirus experts, making it the ideal venue to share our pan-viral protease inhibitor CDI-988 Phase 1 data and clinical development strategy,” said Dr. Lee. “Norovirus causes a highly contagious gastrointestinal illness, triggering severe vomiting and diarrhea, and has a substantial economic impact with a societal cost of approximately $60 billion each year globally according to the CDC. There is no approved vaccine or antiviral therapeutics for norovirus infection. We are encouraged by our molecule’s novel pan-viral activity against all noroviruses including GII.4 and GII.17 strains.”

Pan-Viral Inhibitor CDI-988
CDI-988 was designed and developed with Cocrystal’s proprietary structure-based platform technology as a broad-spectrum inhibitor to a highly conserved region in the active site of 3CL viral proteases. Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 represents a compelling first-in-class oral treatment for noroviruses, which are members of the calicivirus family, and for coronaviruses. Cocrystal has completed a single-center, randomized, double-blind, placebo-controlled Phase 1 study in healthy adults evaluating the safety, tolerability and pharmacokinetics of CDI-988, including a food effect cohort.

Structure-Based Platform Technology
Cocrystal’s proprietary structural biology, along with its expertise in enzymology and medicinal chemistry, enable its development of novel antiviral agents. The Company’s platform provides a three-dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide structure activity relationships. 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.

About the Calicivirus Conference
The International Calicivirus Conference is held every three years and unites scientists from across the globe who study calicivirus virology, evolution, pathogenesis, structural biology, diagnosis, epidemiology, treatment and prevention. The conference aims to foster open discussions, spark new collaborations and explore groundbreaking research. Delegates have the opportunity to engage with the latest advances in the field through state-of-the-art lectures, oral presentations and poster sessions.

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.

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 for the Company’s CDI-988 product candidate as a treatment for 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, our need for additional capital to fund our operations over the next 12 months, risks relating to our ability to obtain regulatory approval 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, regulatory changes, and potential development of effective treatments and/or vaccines by competitors, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the impact of the Trump Administration’s policies and actions on regulation affecting the FDA and other healthcare agencies and potential staffing issues resulting therefrom, as well as other government actions such as tariffs which may cause delays or force us to incur additional costs to proceed without development programs. 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, 2024. 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.

Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com

# # #

Primary Logo

Source: Cocrystal Pharma, Inc.

Release – Cocrystal Pharma’s Investigational Drug Candidate CC-42344 Demonstrates Strong Antiviral Potency Against the 2024 Highly Pathogenic H5N1 Avian Influenza Strain

Research News and Market Data on COCP

May 29, 2025

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  • CC-42344 was shown to be highly active against the highly pathogenic 2024 Texas H5N1 avian influenza strain
  • The Company’s virology study further confirmed the previous structural and in vitro data that revealed the binding of CC-42344 to PB2 protein of the 2024 H5N1 avian influenza virus

BOTHELL, Wash., May 29, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces 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. CC-42344 is a new investigational drug candidate for the treatment of pandemic and seasonal influenza infections. This inhibitor binds to a highly conserved active site of the PB2 protein and inhibits the viral replication process. The Company previously announced the structural and in vitro data of CC-42344 with the purified H5N1 PB2 protein.

The virology study utilized the highly pathogenic H5N1 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 influenza virus (EC50, 0.003 µM), approximately 1,000-fold more potent, compared to a refence compound Tamiflu (EC50, 2.69 µM). 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.

“We are excited to share these H5N1 results that further validate our structure-based drug discovery platform technology and strengthen our position in developing treatments for influenza infection,” said Sam Lee, PhD, President and co-CEO of Cocrystal Pharma. “These important antiviral data along with the favorable safety profile observed in a Phase 1 study support further clinical evaluation of CC-42344 for pandemic and seasonal flu.”

“We are developing a therapeutic candidate with the potential to address the multibillion-dollar influenza market,” said James Martin, CFO and co-CEO of Cocrystal Pharma. “Influenza is a major global health concern that may become more challenging to treat as highly pathogenic avian viruses emerge and become resistant to approved antivirals. On average, in the U.S. about 8% of the population contracts influenza each season and influenza is responsible for an estimated $11.2 billion in direct and indirect costs annually.”

Avian Influenza
A multistate outbreak of highly pathogenic avian influenza in dairy cows was initially reported in March 2024 and was the first time that avian flu viruses were found in cows. In April 2024 the Centers for Disease Control and Prevention (CDC) confirmed an avian flu infection in a person exposed to dairy cows that were presumed to be infected with the virus. This is believed to be the first instance of likely mammal-to-human spread of this virus. In September 2024 the CDC reported the first human case of avian influenza without a known occupational exposure to sick or infected animals.

The CDC analyzed blood collected from people of all ages in all 10 Department of Health and Human Services regions during the 2022-2023 and 2021-2022 flu seasons. These samples were challenged with the avian flu subtype H5N1 virus to determine 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 participants received a seasonal flu vaccination, meaning that seasonal flu vaccination did not produce antibodies to avian flu H5N1 viruses.

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 influenza including the avian influenza A H5N1 virus 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 our plans to complete a Phase 2a study for CC-42344, 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 including based on initiatives and actions taken by the Trump Administration which could, among other things, result in delays in regulatory approvals or limit access to federal funding for our programs, and potential development of effective treatments and/or vaccines by competitors and 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, 2024. 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.

Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com

# # #

Primary Logo

Source: Cocrystal Pharma, Inc.

Released May 29, 2025

Cocrystal Pharma (COCP) – 1Q25 Reported With Clinical Trial Milestone Updates


Monday, May 19, 2025

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.

Fourth Quarter Included New Data On Norovirus Variants. Cocrystal reported a 1Q25 loss of $2.3 million or $(0.23) per share. During the quarter the company announced Phase 1 results from its CDI-988 study in norovirus. Importantly, preclinical data showed efficacy against new norovirus variants. We believe this provides additional support to Cocrystal’s method of targeting highly-conserved viral replication enzymes to make effective drugs against both current and future variants. Cash on March 31, 2025 was $6.9 million.

CDI-988 Activity Includes New Variant Strains. CDI-988 is a protease inhibitor in development for norovirus and corona virus. CDI-988 has shown activity against multiple strains, with new preclinical data in April 2025 showing efficacy against the GII.17 and GII.4 strains that have recently been most prevalent. Results from the Phase 1 high-dose cohort in healthy subjects is expected to be announced in 2Q2025. A human challenge trial is planned for later in FY2025 to evaluate CDI-988 for treatment and prophylaxis against norovirus.


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Release – Cocrystal Pharma Reports First Quarter 2025 Financial Results and Provides Updates on its Antiviral Drug-Development Programs

Research News and Market Data on COCP

May 15, 2025

In vitro testing with CDI-988 demonstrated superior broad-spectrum antiviral activity against major norovirus variants

BOTHELL, Wash., May 15, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the three months ended March 31, 2025, and provides updates on its antiviral product pipeline, upcoming milestones and business activities.

“Our oral pan-viral protease inhibitor CDI-988 is a potential breakthrough first-in-class treatment and prophylaxis for norovirus, a debilitating gastrointestinal infection that strikes millions globally each year,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “By precisely targeting the virus’ core replication machinery, we believe CDI-988 effectively combats all major strains of this highly contagious pathogen with exceptional in vitro activity demonstrated against the current circulating GII.17 and GII.4 strains. We’re preparing to launch a U.S. human challenge study in the coming months – a critical step in advancing this transformative therapy to patients worldwide.

“Our novel, broad-spectrum drug candidates have the potential to fundamentally transform how we fight viral threats worldwide,” said James Martin, CFO and co-CEO of Cocrystal. “We’re advancing development of these assets for multibillion-dollar markets while remaining committed to a capital-efficient business model to maximize shareholder value.”

Antiviral Product Pipeline Overview

We harness our revolutionary structure-based drug discovery platform technology to engineer next-generation, broad-spectrum antivirals that precisely disrupt viral replication mechanisms. Unlike traditional approaches, our platform technology identifies compounds that bind to highly conserved regions of viral enzymes, thereby creating a formidable defense against current viral threats as well as their mutations. By specifically targeting these evolutionary-constrained viral regions, our candidates maintain efficacy even as viruses mutate, while simultaneously minimizing off-target interactions that typically lead to adverse side effects. This dual advantage represents a significant breakthrough in antiviral drug development. Our innovative methodology fundamentally transforms the conventional drug discovery paradigm by eliminating the inefficient, resource-intensive cycles of high-throughput compound screening and prolonged hit-to-lead optimization. The result is faster identification of promising candidates with superior resistance profiles and safety characteristics.

Influenza Programs
Influenza is a major global health threat that may become more challenging to treat due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Each year there are approximately 1 billion cases of seasonal influenza worldwide, 3-5 million severe illnesses and up to 650,000 deathsOn average, about 8% of the U.S. population contracts influenza each seasonIn addition to the health risk, influenza is responsible for an estimated $11.2 billion in direct and indirect costs in the U.S. annually.

  • Oral CC-42344 for the treatment of pandemic and seasonal influenza A
    • Our novel PB2 inhibitor CC-42344 showed excellent in vitro activity against pandemic and seasonal influenza A strains, as well as strains that are resistant to Tamiflu® and Xofluza®.
    • In December 2022 we reported favorable safety and tolerability results from the oral CC-42344 Phase 1 study.
    • In December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, viral and clinical measurements of CC-42344 in influenza A-infected subjects in the United Kingdom, following authorization from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
    • In May 2024 we completed enrollment in the Phase 2a human challenge study.
    • In June 2024 we reported that in vitro studies demonstrated CC-42344 inhibits the activity of the highly pathogenic avian influenza A (H5N1) PB2 protein identified in humans exposed to infected dairy cows.
    • In December 2024 we announced a plan to extend the CC-42344 Phase 2a human challenge study due to unexpectedly low influenza infection among study participants.
  • Inhaled CC-42344 as prophylaxis and treatment for pandemic and seasonal influenza A
    • Our preclinical testing showed superior pulmonary pharmacology with CC-42344, including high exposure to drug and a long half-life.
    • Dry powder inhalation formulation development and toxicology studies have been completed.
  • Influenza A/B program
    • Our efforts to develop a preclinical lead of novel influenza replication inhibitors are ongoing.

Norovirus Program
Norovirus is a common and highly contagious virus that causes symptoms of acute gastroenteritis among people of all ages including nausea, vomiting, stomach pain and diarrhea as well as fatigue, fever and dehydration. Norovirus infection can be significantly more severe and prolonged in specific risk groups including infants, children, the elderly and people with immunodeficiency. Norovirus outbreaks occur most commonly in semi-closed communities and have become notorious for their occurrence in hospitals, nursing homes, childcare facilities, cruise ships, schools, disaster relief sites and military settings.

In the U.S. alone, noroviruses are responsible for an estimated 21 million cases annually, including 109,000 hospitalizations, 465,000 emergency department visits and an estimated 900 deaths. The annual burden of norovirus to the U.S. is estimated at $10.6 billion. Noroviruses are responsible for up to 1.1 million hospitalizations and 218,000 deaths annually in children in the developing world. There is currently no effective treatment or effective vaccine for norovirus, and the ability to curtail outbreaks is limited.

  • Oral pan-viral protease inhibitor CDI-988 for the treatment of noroviruses and coronaviruses
    • Our novel, broad-spectrum protease inhibitor CDI-988 is being evaluated as a potential oral treatment for noroviruses and coronaviruses.
    • CDI-988 has shown in vitro pan-viral activity against multiple norovirus strains.
    • 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 pharmacokinetics (PK) of oral CDI-988 in healthy subjects.
    • In August 2023 we announced our selection of CDI-988 as our lead compound for the oral treatment for noroviruses, in addition to coronaviruses.
    • In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study.
    • In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a high-dose cohort.
    • In April 2025 we announced that CDI-988 showed superior broad-spectrum antiviral activity against GII.17 strains, the most prevalent strain in the U.S. and European countries in 2024-2025.
    • We expect to report topline oral CDI-988 Phase 1 results from the high-dose healthy subject cohort in the second quarter of 2025.
    • We plan to initiate a human challenge study in the U.S. in the coming months to evaluate CDI-988 as a norovirus treatment and prophylaxis.

SARS-CoV-2 and Other Coronavirus Program
By targeting viral replication enzymes and proteases, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including SARS-CoV-2 and its variants, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). CDI-988 showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses, as well as against noroviruses. The global COVID-19 therapeutics market is estimated to exceed $16 billion annually by the end of 2031.

  • Oral pan-viral protease inhibitor CDI-988 for the treatment of coronaviruses and noroviruses
    • CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and demonstrated a favorable safety profile and PK properties.
    • In September 2023 we dosed the first healthy subject in our dual pan-norovirus/pan-coronavirus oral CDI-988 study, which is expected to serve as a Phase 1 study for both indications.
    • In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study.
    • In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a high-dose cohort.
    • We expect to report topline oral CDI-988 Phase 1 results from the high-dose healthy subject cohort in the second quarter of 2025.

First Quarter Financial Results

Research and development (R&D) expenses for the first quarter of 2025 were $1.4 million, compared with $3.0 million for the first quarter of 2024, with the decrease primarily due to a reduction in personnel costs and the timing of clinical study costs. General and administrative (G&A) expenses for the first three months of 2025 were $1.0 million, compared with $1.2 million for the first three months of 2024, with the decrease primarily due to a reduction in insurance costs and other expenses.

Net loss for the first quarter of 2025 was $2.3 million, or $0.23 per share, compared with net loss for the first quarter of 2024 of $4.0 million, or $0.39 per share.

Cocrystal reported unrestricted cash as of March 31, 2025 of $6.9 million, compared with $9.9 million as of December 31, 2024. Net cash used in operating activities for the first quarter of 2025 was $2.9 million, compared with $4.5 million for the first quarter of 2024. The Company had working capital of $6.9 million and 10.2 million common shares outstanding as of March 31, 2025.

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. 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 product candidates including the potential of our norovirus product candidate, our plans to initiate a human challenge study for our norovirus product candidate, and our plans with regard to initiating a second human challenge study for CC-42344 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 our need for additional capital to fund our operations over the next 12 months, inflation, the possibility of a recession, interest rate increases, imposed and threated tariffs, and geopolitical conflicts including those 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 including any adverse impacts on our ability to obtain raw materials for and otherwise 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 progress and results of the studies for CC-42344 and CDI-988 including the delay of the Phase 2a study for CC-42344 which may require us to incur substantial additional costs, the ability of us and our CROs to recruit volunteers for, and to otherwise 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 including potential downward pressure on government spending on the biopharmaceutical and healthcare industry based on policies and actions taken by the Trump Administration in the U.S., the impact of the Trump Administration’s policies and actions on regulation affecting the FDA and other healthcare agencies and potential staffing issues resulting therefrom, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the potential for the development of effective treatments by competitors which could reduce or eliminate a prospective future market share commercializing any product candidates we may develop in the future, and our ability to meet our future liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024. 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.

Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com

View full release here.

Release – Cocrystal Pharma’s Norovirus Oral Antiviral Candidate Demonstrates Potent Activity Against the Emerging GII.17 Variants

Research News and Market Data on COCP

April 24, 2025

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  • Norovirus GII.17 variants have overtaken GII.4 as the most prevalent strain and significantly increased norovirus outbreaks in the U.S. and European countries in 2024-2025
  • Cocrystal Pharma’s pan-viral protease inhibitor CDI-988 shows superior broad-spectrum antiviral activity against major norovirus variants including GII.4 and GII.17 strains
  • Company reported favorable safety and tolerability of CDI-988 in Phase 1 and plans to initiate a human challenge study in 2025 for the treatment and prevention of norovirus infection

BOTHELL, Wash., April 24, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces 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 is the most common cause of acute gastroenteritis worldwide, yet there are no approved antiviral treatments or vaccines available to combat it,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “Norovirus antiviral and vaccine development has been extremely challenging due to high diversity among variants that include 10 genogroups and 49 genotypes. We are gratified to have determined the first crystal structure of GII.17 protease and demonstrated broad-spectrum antiviral activity of CDI-988 against newly circulating major norovirus GII.17 variants. Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 is a compelling candidate for advancement as a first-in-class oral antiviral to be used for both prevention and treatment of norovirus infection.”

“Norovirus is a noteworthy research target considering that each year an estimated 685 million cases and approximately 50,000 child deaths are attributed to this virus worldwide, leading to a societal cost estimated at $60 billion,” said James Martin, Cocrystal’s CFO and co-CEO. “We are addressing the urgent need for norovirus and other emerging viral outbreaks through our platform technology that facilitates the rapid, efficient development of potentially highly effective and safe direct-acting antivirals.”

Pan-Viral Inhibitor CDI-988
CDI-988 is a protease inhibitor specifically designed and developed as a broad-spectrum antiviral inhibitor to a highly conserved region in the active site of 3CL viral proteases. Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 is a compelling candidate for advancement as a first-in-class oral treatment for both noroviruses and coronaviruses. The Company has completed a single-center, randomized, double-blind Phase 1 study in healthy adults evaluating safety, tolerability and pharmacokinetics including a food-effect cohort of orally administered CDI-988 compared with placebo.

Structure-Based Platform Technology
Cocrystal’s proprietary structural biology, along with its expertise in enzymology and medicinal chemistry, enable its development of novel antiviral agents. The Company’s platform provides a three-dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide Structure Activity Relationships. 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.

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 noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2), 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 Cocrystal’s plans to initiate a human challenge study in 2025 for its oral norovirus product candidate, the potential efficacy of such product candidate, 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, our need for additional capital to fund our operations over the next 12 months, risks relating to our ability to obtain regulatory authority for and proceed with clinical trials including the recruiting of volunteers for such studies by our clinical research organizations and vendors, the results of such studies, 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, and potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the impact of the Trump Administration’s policies and actions on regulations affecting the FDA and other healthcare agencies and potential staffing issues resulting therefrom, as well as other government actions such as tariffs which may cause delays or force us to incur additional costs to proceed with our development programs. 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, 2024. 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.

Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com

# # #

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Source: Cocrystal Pharma, Inc.

Released April 24, 2025

Cocrystal Pharma (COCP) – FY2024 Reported With Clinical Trials On Schedule


Tuesday, April 01, 2025

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.

Fourth Quarter and FY2024 Reported. Cocrystal reported a 4Q24 loss of $3.1 million or $(0.31) per share and a FY2024 loss of $17.5 million or $(1.72) per share. The company reviewed the progress it has made in 4Q24 and YTD with CC-988 for norovirus/coronavirus and with CPI-42344 for influenza. The cash balance on December 31, 2024, was $9.9 million.

Human Challenge Study Planned For CC-988 In Norovirus. Cocrystal is planning a human challenge study to test CC-988, its protease inhibitor for norovirus and coronaviruses. The new trial follows the results of the Phase 1 ascending dose studies announced in December 2024, showing safety and tolerability. Results from an additional high-dose cohort are expected in 2Q25. The Phase 2a human challenge study is expected to begin later in 2025.


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