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Cocrystal Pharma to Present at Life Science Innovation Northwest 2025 Conference
Globenewswire· 2025-04-16 12:00
Group 1: Company Overview - Cocrystal Pharma, Inc. is a clinical-stage biotechnology company focused on discovering and developing novel antiviral therapeutics targeting the replication processes of various viruses, including influenza, coronaviruses (such as SARS-CoV-2), noroviruses, and hepatitis C viruses [3] - The company utilizes unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs [3] Group 2: Event Information - Sam Lee, President and co-CEO of Cocrystal Pharma, will present a company overview at the Life Science Innovation Northwest (LSINW) 2025 Conference on April 23, 2025, at 3:00 p.m. Pacific time [1] - The LSINW conference is the largest annual life science event in the Pacific Northwest, featuring over 700 attendees and 80+ presentations from companies and research institutions [2] - The conference includes keynote addresses from industry leaders, panel discussions on emerging trends, and a startup fast pitch showdown, making it a significant event for the life science community in the region [2]
Cocrystal(COCP) - 2024 Q4 - Annual Report
2025-03-31 12:30
Financial Performance and Capital Needs - The company has an accumulated deficit of $333,418,000 from inception through December 31, 2024, and expects to continue incurring losses in the future [69]. - The company has never generated revenue from product sales and does not anticipate doing so for at least four years [68]. - The company has limited capital and substantial accumulated deficit, raising concerns about its ability to continue operations without obtaining additional financing [67]. - The company may need to raise additional capital or form strategic partnerships to support its research and development activities, which may not yield the desired results [74]. - The company may need to accept unfavorable terms in future financing efforts, which could restrict its ability to raise capital or pursue development opportunities [80]. - The company may need significant additional capital in the future to fund operations, which could lead to substantial dilution for existing stockholders [177]. - Future sales of large amounts of common stock or the perception of such sales could significantly decrease the stock price, even if the business performs well [182]. - The company may experience limitations on using net operating loss carryforwards due to potential ownership changes, which could increase future tax liabilities [183]. - The issuance of preferred stock could complicate third-party acquisitions and potentially depress the stock price [185]. - The company may face challenges in attracting new investors due to potential dilution from future capital raises [177]. Clinical Trials and Regulatory Challenges - The company is currently facing challenges in conducting clinical trials, including the need to extend enrollment for the oral CC-42344 Phase 2a study due to insufficient infection rates [73]. - The company is dependent on the successful completion of clinical trials and obtaining regulatory approvals to commercialize its product candidates [70]. - The company may face significant delays or failures in clinical trials due to adverse events or serious adverse events observed during testing [107]. - The commercial success of product candidates will depend on successful completion of clinical trials and obtaining marketing approvals [103]. - The company may need to conduct additional clinical trials if initial results are not positive, which could further delay commercialization [104]. - The ability to generate revenue is contingent upon obtaining regulatory approvals, which are expensive and time-consuming [99]. - Approximately 70% of drugs proceed past Phase 1 studies, 33% past Phase 2, and only 25%-30% reach Phase 4 in the FDA review process, highlighting the challenges in obtaining regulatory approval [98]. - The company has limited experience in conducting and managing preclinical development activities and clinical trials necessary for obtaining marketing approvals [120]. - The company has only entered a limited number of compounds into human clinical trials, including an influenza A product candidate in Phase 2a and a norovirus/coronaviruses product candidate in Phase 1 [120]. - The company has not obtained marketing approval or commercialized any of its product candidates, which may significantly harm its business if clinical trials are unsuccessful [121]. Competition and Market Dynamics - The company faces significant competition from major companies that have developed vaccines or treatments, which could adversely affect its market share and future prospects [78]. - The biotechnology and pharmaceutical industries are intensely competitive, with competitors having greater financial and technical resources, which could adversely affect the company's operating results [135]. - The company is focusing on programs in preclinical or early clinical development stages, facing competition from approved products and candidates in the market [136]. - Market acceptance of the company's product candidates will depend on factors such as clinical safety, efficacy, pricing, and reimbursement policies from third-party payors [148]. - The commercial success of the company's product candidates will depend on acceptance by the medical community, including physicians and healthcare payors [147]. Intellectual Property and Legal Risks - The company relies on a combination of patents, trade secret protection, and confidentiality agreements to protect its intellectual property, but there is uncertainty regarding the strength of these protections [122]. - The company may face significant challenges in obtaining or protecting necessary rights to drug compounds and processes for its development pipeline through acquisitions and in-licenses [114]. - The company may encounter significant problems in protecting and defending its intellectual property both in the United States and abroad, particularly in light of international agreements like the WTO waiver on patent protection for COVID-19 vaccines [125]. - The company’s commercial success depends on avoiding infringement on third-party patents, which poses a risk of litigation and could materially affect its business [126]. - The company may be required to file infringement claims or defend the validity of its patents, which can be expensive and time-consuming [130]. - The company may lack the capital to defend its intellectual property rights due to the costs involved in patent litigation [129]. - The company faces risks related to the disclosure of confidential information during intellectual property litigation, which could adversely affect its stock price [132]. - The company may need to obtain additional licenses for intellectual property rights from third parties, which could significantly harm its business if not acquired at reasonable costs or terms [133]. Operational and Management Challenges - The company relies on third-party partners for clinical trials and research, which has led to delays and increased costs due to staffing shortages and pandemic-related issues [82]. - The company relies on third-party manufacturers for preclinical and clinical supplies, which exposes it to risks such as supply chain shortages and manufacturing capacity issues [85]. - If third-party manufacturing issues arise, it could lead to increased costs or delays in obtaining regulatory approval and commercialization [89]. - The company expects to rely on limited sources for drug substances, which may cause delays in product development if supply is disrupted [87]. - Compliance with current Good Clinical Practices (cGCPs) is critical, as failure to do so may result in unreliable clinical data and additional trials being required [91]. - The company is highly dependent on key management and scientific personnel, and losing these individuals could materially impact its business [157]. - The company may face challenges in establishing sales and marketing capabilities, which are critical for generating product revenues [152]. - The company may experience increased operating expenses and reduced revenues due to foreign currency fluctuations and geopolitical actions [158]. - The company is vulnerable to business interruptions from natural disasters and pandemics, which could delay research and development efforts [165]. - The company may face cybersecurity threats that could disrupt operations and compromise confidential information, impacting its business [140]. - The company is exposed to risks from cybersecurity threats that could compromise sensitive information and disrupt operations [167]. - The adoption of artificial intelligence by competitors may put the company at a competitive disadvantage if it does not integrate similar technologies into its operations [143]. - The company anticipates significant capital expenditures for future growth, which may divert financial resources from other projects [159]. - The company faces potential product liability claims which could incur substantial costs and impact its financial performance [163]. - The company may face challenges in managing growth, potentially leading to operational mistakes and reduced productivity [159]. Stock and Market Considerations - As of March 28, 2025, approximately 10.2 million shares of common stock are outstanding, with about 6.8 million shares free trading or subject to Rule 144 sales limitations [179]. - Approximately 550,000 options and 256,000 RSUs are outstanding, which could result in the issuance of 806,000 shares of common stock if fully exercised [181]. - The absence of research coverage from major brokerage firms may hinder the development of an active market for the company's common stock [184]. - The company’s amended Bylaws establish exclusive forums for certain disputes, which may increase litigation costs and affect stockholder claims [187]. - The company operates in a volatile stock market environment, with potential impacts from geopolitical conflicts and economic uncertainty [176]. - The company is subject to various federal and state healthcare fraud and abuse laws, which could result in penalties and affect its operations [160]. - The company may incur substantial costs to comply with environmental, health, and safety laws, which could adversely affect its operations [170]. - The company is subject to additional restrictions on shares held by affiliates, limiting their ability to sell stock [181].
Cocrystal(COCP) - 2024 Q4 - Annual Results
2025-03-31 12:30
Financial Performance - Cocrystal Pharma reported a net loss of $17.5 million for 2024, a decrease of $3.1 million compared to the net loss of $18.0 million in 2023[10]. - Net loss narrowed to $17,504 million in 2024 compared to a net loss of $17,984 million in 2023, showing an improvement of approximately 2.6%[19]. - Net loss per common share improved to $1.72 in 2024 from $1.87 in 2023, reflecting a decrease of about 8.0%[19]. - Total operating expenses decreased to $17,878 million in 2024 from $18,559 million in 2023, a reduction of approximately 3.7%[19]. Research and Development - Research and development (R&D) expenses for 2024 were $12.5 million, down from $15.2 million in 2023, primarily due to the timing of clinical study costs[9]. - Research and development expenses were $12,537 million in 2024, down from $15,169 million in 2023, representing a decrease of about 17.4%[19]. - Cocrystal's oral PB2 inhibitor CC-42344 is being evaluated for its potential to treat seasonal influenza A and pandemic avian influenza, with a Phase 2a study ongoing[3]. - The company plans to initiate a norovirus human challenge study in the U.S. in 2025 to evaluate the oral pan-viral protease inhibitor CDI-988[2]. Market Potential - The global COVID-19 therapeutics market is projected to exceed $16 billion annually by the end of 2031, highlighting the market potential for Cocrystal's antiviral products[8]. - Norovirus is responsible for an estimated 685 million cases and 50,000 child deaths worldwide each year, with a societal cost of $60 billion[6]. - Cocrystal's antiviral drug compounds target multibillion-dollar markets, addressing critical gaps in global health[3]. Cash and Capital - As of December 31, 2024, unrestricted cash was $9.9 million, a significant decrease from $26.4 million as of December 31, 2023[11]. - The company had working capital of $9.2 million and 10.2 million common shares outstanding as of December 31, 2024[11]. - Weighted average number of common shares outstanding increased to 10,174 million in 2024 from 9,651 million in 2023, an increase of approximately 5.4%[19]. Other Financial Metrics - General and administrative (G&A) expenses decreased to $5.3 million in 2024 from $6.0 million in 2023, attributed to reduced insurance costs[9]. - General and administrative expenses decreased to $5,341 million in 2024 from $5,990 million in 2023, a reduction of approximately 10.9%[19]. - Interest income, net decreased to $537 million in 2024 from $640 million in 2023, a decline of about 16.1%[19]. - Foreign exchange loss increased to $163 million in 2024 from $65 million in 2023, indicating a rise of approximately 150.8%[19]. - Total other income, net decreased to $374 million in 2024 from $575 million in 2023, a decline of about 34.9%[19]. - Legal settlement expenses were not applicable in 2024 compared to a $2,600 million expense in 2023, indicating a significant reduction[19].
Cocrystal Pharma Reports 2024 Financial Results and Provides Updates on its Antiviral Drug-Development Programs
Newsfilter· 2025-03-31 12:00
Antiviral Product Pipeline Overview "We are optimistic that our oral PB2 inhibitor CC-42344 will have potential as a treatment for seasonal influenza A infection and pandemic avian influenza," he added. "Following the unexpected low infection rate from the Phase 2a challenge study that precluded us from obtaining meaningful human efficacy data, we plan to continue the influenza challenge study." "News coverage in recent months of norovirus and avian flu outbreaks underscore the urgent need for new antiviral ...
Cocrystal Pharma to Participate in a Fireside Chat at the Zacks SCR Life Sciences Virtual Investor Forum on March 13, 2025
Globenewswire· 2025-03-06 13:00
BOTHELL, Wash., March 06, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that management will participate in a fireside chat at the Zacks SCR Life Sciences Virtual Investor Forum on Thursday, March 13, 2025 at 11:30 a.m. Eastern time (8:30 a.m. Pacific time). The fireside chat will be hosted by Zacks Small Cap Research Senior Analyst David Bautz, PhD. Pre-register for Cocrystal’s virtual presentation is available on the Cocrystal website here. Investors will have the opportunity to ...
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
Globenewswire· 2025-01-08 13:00
Data show favorable safety and tolerability with dosing up to 800 mg for 10 daysPlans to initiate human challenge study in 2025 in norovirus-infected subjects BOTHELL, Wash., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) 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 ...
Cocrystal(COCP) - 2024 Q3 - Quarterly Results
2024-11-13 20:30
Financial Performance - The net loss for Q3 2024 was $4.9 million, or $0.49 per share, compared to a net loss of $4.2 million, or $0.41 per share in Q3 2023[13]. - The net loss for the first nine months of 2024 was $14.2 million, or $1.40 per share, compared to a net loss of $13.5 million, or $1.43 per share in the first nine months of 2023[14]. - Net loss for the three months ended September 30, 2024, was $4,939,000, compared to a net loss of $4,165,000 for the same period in 2023, representing an 18.6% increase in loss[20]. - Net loss per common share for the three months ended September 30, 2024, was $(0.49), compared to $(0.41) for the same period in 2023[20]. Research and Development - Research and development (R&D) expenses for Q3 2024 were $3.2 million, a decrease of 23.8% from $4.2 million in Q3 2023[12]. - For the first nine months of 2024, R&D expenses totaled $10.5 million, slightly down from $10.9 million in the same period of 2023[14]. - Research and development expenses for the three months ended September 30, 2024, were $3,242,000, a decrease of 22.7% from $4,194,000 in the same period of 2023[20]. - The company expects to report topline results from the Phase 2a influenza A challenge study by year-end 2024[2]. - Cocrystal is on track to report topline results from the Phase 1 study of CDI-988 in late 2024 or early 2025[3]. - The company plans to file an IND application in 2025 for a late-stage study of CC-42344 in the U.S.[6]. Cash and Assets - Unrestricted cash as of September 30, 2024, was $13.0 million, down from $26.4 million as of December 31, 2023[15]. - Cash balance decreased to $13,020,000 as of September 30, 2024, down 50.7% from $26,353,000 on December 31, 2023[19]. - Total current assets decreased to $14,256,000 as of September 30, 2024, down 51% from $29,091,000 on December 31, 2023[19]. - Total stockholders' equity decreased to $12,703,000 as of September 30, 2024, down 51.8% from $26,384,000 on December 31, 2023[19]. Liabilities and Expenses - Total liabilities decreased to $3,530,000, a reduction of 27.6% from $4,875,000 as of December 31, 2023[19]. - Total operating expenses increased to $5,042,000 for the three months ended September 30, 2024, up 13.5% from $4,443,000 in the same period of 2023[20]. - Interest income for the three months ended September 30, 2024, was $111,000, a decrease of 65.3% from $320,000 in the same period of 2023[20]. Market Insights - Norovirus causes approximately 685 million cases and 50,000 child deaths annually, with a societal cost of $60 billion[8]. - The global COVID-19 therapeutics market is projected to exceed $16 billion by the end of 2031[10].
Cocrystal(COCP) - 2024 Q3 - Quarterly Report
2024-11-13 13:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38418 COCRYSTAL PHARMA, INC. (Exact name of registrant as specified in its charter) | --- | --- | --- | --- | --- | --- | --- | --- | ...
Cocrystal Pharma to Highlight Near-term Clinical Milestones During Presentations at Two Upcoming Investment Conferences
GlobeNewswire News Room· 2024-08-19 20:05
BOTHELL, Wash., Aug. 19, 2024 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc.'s (Nasdaq: COCP) management announces its participation in the upcoming Virtual Investor Summit Microcap Forum in August and the H.C. Wainwright 26th Annual Global Investment Conference in September. "We look forward to showcasing key near-term clinical milestones at two upcoming investment conferences," said James Martin, CFO and co-CEO of Cocrystal. "We expect to report topline results in 2024 from our influenza A Phase 2a challenge ...
Cocrystal(COCP) - 2024 Q2 - Quarterly Results
2024-08-14 12:15
Exhibit 99.1 1 Cocrystal Pharma Reports Second Quarter 2024 Financial Results and Provides Updates on its Antiviral Drug-Development Programs ● Expects to report topline results in 2025 from Phase 2a influenza A human challenge study with oral CC-42344, including initial indication of virology ● In vitro testing shows CC-42344 inhibits the avian influenza A (H5N1) PB2 protein recently identified in U.S. dairy cows ● Expects to report topline results in late 2024 or early 2025 from Phase 1 study with oral CD ...