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Cocrystal(COCP) - 2024 Q2 - Quarterly Report
2024-08-14 12:00
Research and Development - Total research and development expenses for the six months ended June 30, 2024, were $7,258,000, an increase of $550,000 compared to $6,708,000 for the same period in 2023, primarily due to ongoing clinical trials [82]. - Research and development expenses for the three months ended June 30, 2024, were $4,308,000, up from $2,801,000 in 2023, reflecting the advancement of the Influenza CC-42344 product candidate into a Phase 2a clinical trial [82]. - The company completed enrollment of 78 subjects in the Phase 2a human challenge study for oral CC-42344 in May 2024 [65]. - CC-42344 demonstrated excellent antiviral activity against influenza A strains, including avian pandemic strains and strains resistant to existing treatments [64]. - The company is developing inhaled CC-42344 for prophylactic treatment of influenza A infections, with preclinical data showing excellent antiviral activity [66]. - Oral CDI-988, a novel protease inhibitor for noroviruses and coronaviruses, is being evaluated in a Phase 1 study in Australia, with favorable safety results reported [67]. - The company has identified promising inhibitors targeting norovirus replication enzymes, with potential for effective treatment across all genogroups [77]. Market Opportunity - The global hepatitis C market is projected to remain significant, with an estimated 50 million people worldwide having chronic HCV infections [79]. - CC-31244, an HCV NNI, is being developed for ultra-short treatment regimens of four to six weeks, aiming for a high sustained virologic response [80]. - Influenza is responsible for approximately $10.4 billion in direct medical costs annually in the U.S., highlighting the significant market opportunity for effective antiviral treatments [68]. Financial Performance - Interest income for the six months ended June 30, 2024, was $371,000, a significant increase from $140,000 for the same period in 2023, representing a growth of 164.3% [84]. - Foreign exchange loss for the six months ended June 30, 2024, was $64,000, compared to $45,000 for the same period in 2023, indicating a 42.2% increase [85]. - Net loss for the six months ended June 30, 2024, was $9,299,000, slightly improved from a net loss of $9,355,000 for the same period in 2023 [87]. - Net cash used in operating activities decreased to $8,202,000 for the six months ended June 30, 2024, from $8,659,000 in the same period of 2023, a reduction of 5.3% [87]. - The company had $18,143,000 in unrestricted cash as of June 30, 2024, which is expected to sustain operations for more than the next 12 months [88]. - The company has not yet established a source of revenue sufficient to cover its operating costs and has incurred operating losses since inception [89]. - The company has not conducted any sales under the At-The-Market Offering Agreement during the six months ended June 30, 2024, despite having the capacity to issue up to $10,000,000 in shares [90]. - Future profitability is contingent upon the successful development and commercialization of product candidates, with no assurance that profitability will be achieved [91]. - The company has incurred operating losses and negative operating cash flows on an annual basis since inception, indicating ongoing financial challenges [89].
Cocrystal Pharma Reports Favorable Results from Single-Ascending Dose Cohorts of Phase 1 Study with CDI-988, its Oral Pan-Viral Norovirus/Coronavirus Protease Inhibitor
Newsfilter· 2024-07-18 12:00
BOTHELL, Wash., July 18, 2024 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (NASDAQ:COCP) ("Cocrystal" or the "Company") today reported favorable safety and tolerability results from the singleascending dose (SAD) cohorts of the Phase 1 study in healthy volunteers with CDI-988, its potent, oral, panviral protease inhibitor. CDI-988 was specifically designed and developed using Cocrystal's proprietary structure-based drug discovery platform technology as a broad-spectrum antiviral inhibitor to a highly conserve ...
Cocrystal(COCP) - 2024 Q1 - Quarterly Results
2024-05-13 12:15
Clinical Trials - Enrollment completed in Phase 2a influenza A human challenge study of oral CC-42344, with topline results expected in the second half of 2024[1] - The company expects to initiate a Phase 1 study of inhaled CC-42344 in the second half of 2024[5] - Topline results from the SAD cohort of the Phase 1 study with oral CDI-988 are expected in the second quarter of 2024[17] - The company received FDA pre-IND feedback for oral CC-42344 in Q1 2024, providing clarity on late-stage trial design[1] Financial Performance - Net loss for Q1 2024 was $4.0 million, or $0.39 per share, compared to a net loss of $5.2 million, or $0.64 per share in Q1 2023[9] - Net loss for Q1 2024 was $3.956 million, compared to a net loss of $5.189 million in Q1 2023[34] - Net loss per common share for Q1 2024 was $0.39, improved from $0.64 in Q1 2023[34] - Interest income for Q1 2024 was $220,000, with no comparable item for Q1 2023[24] - Foreign exchange loss for Q1 2024 was $18,000, down from $78,000 in the prior-year quarter[24] Expenses and Assets - R&D expenses for Q1 2024 were $3.0 million, a decrease from $3.9 million in Q1 2023, primarily due to reduced clinical preparation expenses[8] - Total operating expenses for Q1 2024 were $4.158 million, down from $5.111 million in Q1 2023[34] - Research and development expenses for Q1 2024 were $2.950 million, down from $3.907 million in Q1 2023[34] - Total current assets decreased to $24.492 million as of March 31, 2024, down from $29.091 million as of December 31, 2023[13] - Total liabilities decreased to $3.961 million as of March 31, 2024, compared to $4.875 million as of December 31, 2023[13] - Unrestricted cash as of March 31, 2024, was $21.8 million, compared to $26.4 million as of December 31, 2023[25] - Net cash used in operating activities for Q1 2024 was $4.5 million, compared to $3.1 million for Q1 2023[25] Market Insights - Approximately 1 billion cases of seasonal influenza occur worldwide each year, leading to direct costs of approximately $10.4 billion in the U.S. annually[4] - The global COVID-19 therapeutics market is estimated to exceed $16 billion by the end of 2031[21] - Norovirus accounts for nearly one in five cases of acute gastroenteritis, with an estimated societal cost of $60 billion annually[23] Future Outlook - The company anticipates significant milestones this year and expects cash to be sufficient to fund operations beyond the next twelve months[18]
Cocrystal(COCP) - 2024 Q1 - Quarterly Report
2024-05-13 12:00
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 March 31, 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) (State or Other Jurisdiction of (I.R.S. Employer Incor ...
Cocrystal Pharma Reports First Quarter 2024 Financial Results and Provides Updates on its Antiviral Drug-Development Programs
Newsfilter· 2024-05-13 12:00
Topline single ascending dose (SAD) Phase 1 results of oral CDI-988, the first potential pan-coronavirus-pan-norovirus oral antiviral, expected in the second quarter of 2024 Enrollment completed in Phase 2a influenza A human challenge study of oral CC-42344, with topline results expected in the second half of 2024FDA pre-IND feedback for oral CC-42344 received in first quarter of 2024 provides better clarity on late-stage trial designInitiation of Phase 1 study of inhaled CC-42344, a potential influenza tre ...
Cocrystal(COCP) - 2023 Q4 - Annual Report
2024-03-28 12:01
● reduced protection for intellectual property rights; ● foreign taxes, including withholding of payroll taxes; ● production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and If we expand our organization, we may experience difficulties in managing growth, which could disrupt our operations. If we obtain FDA approval for any of our product candidates and commercialize those products in the United States, our operations may be directly, or indirectly ...
Cocrystal(COCP) - 2023 Q4 - Annual Results
2024-03-28 12:00
BOTHELL, Wash. (March 28, 2024) – Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company) reports financial results for the 12 months ended December 31, 2023, and provides updates on its antiviral product pipeline, upcoming milestones and business activities. Exhibit 99.1 Cocrystal Pharma Reports 2023 Financial Results and Provides Updates on its Antiviral Drug-Development Programs "We are highly encouraged by the FDA's feedback to our Pre-Investigational New Drug (Pre-IND) package, which provides ...
Cocrystal Pharma Receives Pre-IND Responses from the FDA on Oral CC-42344 for Treating Influenza A
Newsfilter· 2024-03-19 12:00
Feedback provides greater clarity on regulatory requirements for planned Phase 2b trial BOTHELL, Wash., March 19, 2024 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (NASDAQ:COCP) ("Cocrystal" or the "Company") announces it has received Pre-Investigational New Drug (Pre-IND) feedback from the U.S. Food and Drug Administration (FDA) regarding CC-42344 as a potential oral treatment for pandemic and seasonal influenza A. A Pre-IND review provides the opportunity to obtain FDA guidance and clarification on critical ...
Cocrystal(COCP) - 2023 Q3 - Quarterly Report
2023-11-12 16:00
As the Company continues to incur losses, achieving profitability is dependent upon the successful development, approval and commercialization of its product candidates, and achieving a level of revenues adequate to support the Company's cost structure. The Company may never achieve profitability, and unless and until it does, the Company will continue to need to raise additional capital. Management intends to fund future operations through additional private or public equity offerings and through arrangeme ...
Cocrystal(COCP) - 2023 Q2 - Quarterly Report
2023-08-13 16:00
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except per share data) 1. Organization and Business Segments Level 2 — other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement date. Use of the Black-Scholes option pricing model requires the input of subjective assumptions including expected volatility, expected term, and a risk-free interest rate. The Company estimates volatility using a blend of its own historical ...