Core Insights - Cocrystal Pharma, Inc. has reported positive safety and tolerability results for its oral protease inhibitor CDI-988, which is being developed as a treatment for norovirus and coronavirus infections [1][2][3] - The company plans to conduct an additional cohort study with a higher dose of 1,200 mg and a shorter treatment duration of five days to further evaluate CDI-988's safety and pharmacokinetics [1][3] Company Overview - Cocrystal Pharma is a clinical-stage biotechnology company focused on discovering and developing novel antiviral therapeutics targeting the replication processes of various viruses, including noroviruses and coronaviruses [8] - The company utilizes a proprietary structure-based drug discovery platform to develop its antiviral agents, aiming to create first- and best-in-class therapies [6][8] Industry Context - Norovirus outbreaks are increasing in the U.S. and on cruise ships, with nearly 900 passengers affected in December 2024 alone, highlighting a significant unmet medical need for effective antiviral treatments [2][5] - According to the CDC, noroviruses cause an estimated 21 million cases of acute gastroenteritis annually in the U.S., leading to significant healthcare costs and hospitalizations [5]

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].

Research and Development - Total research and development expenses for Q3 2024 were $3,242,000, a decrease of 22.7% from $4,194,000 in Q3 2023[100] - Total research and development expenses for the nine months ended September 30, 2024, were $10,500,000, down 3.7% from $10,902,000 in the same period of 2023[101] - The company completed enrollment of 77 subjects in the Phase 2a human challenge study for oral CC-42344 in May 2024[77] - CC-42344 demonstrated excellent in vitro antiviral activity against influenza A strains, including resistant strains, and is being evaluated in a Phase 2a study[76] - The company is developing CDI-988 as a first-in-class pan-viral treatment for noroviruses and coronaviruses, currently in a Phase 1 study in Australia[79] - CDI-988 showed favorable safety and tolerability results in the single-ascending dose cohorts of the Phase 1 study, with no serious adverse events reported[81] - The company is targeting viral replication enzymes and proteases for the development of effective treatments for norovirus infections[93] - CC-31244 is being developed as a potential best-in-class pan-genotypic inhibitor for HCV, with a focus on ultra-short treatment regimens of four to six weeks[97] Financial Performance - 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, while the nine-month net loss increased to $14,238,000 from $13,520,000[109] - General and administrative expenses decreased by $443,000 to $4,148,000 for the nine months ended September 30, 2024, compared to $4,591,000 in the same period of 2023[103] - Net cash used in operating activities increased to $13,325,000 for the nine months ended September 30, 2024, compared to $11,340,000 for the same period in 2023[110] - Interest income for the three months ended September 30, 2024, was $111,000, down from $320,000 in the same period of 2023, while for the nine months, it increased slightly to $482,000 from $460,000[106] - Foreign exchange loss decreased to $72,000 for the nine months ended September 30, 2024, compared to $87,000 in the same period of 2023[107] - The Company has not established an ongoing source of revenue sufficient to cover its operating costs and intends to fund future operations through additional equity offerings[115] - The Company incurred $8,000 in net cash for investing activities during the nine months ended September 30, 2024, a decrease from $59,000 in the same period of 2023[111] - The Company has focused on research and development activities but has never been profitable on an annual basis, incurring operating losses since inception[113] Market Insights - The global HCV market is estimated to have 50 million chronic infections, with about 1 million new infections occurring annually[96] - Influenza is responsible for approximately $10.4 billion in direct medical costs in the U.S. annually, with around 1 billion cases of seasonal influenza worldwide each year[84] - The Company had $13,020,000 in unrestricted cash as of September 30, 2024, sufficient to maintain planned operations for more than the next 12 months[112] - No income tax benefit or expense was recognized for the three and nine months ended September 30, 2024, maintaining an effective income tax rate of 0.00%[108]

Core Viewpoint - Cocrystal Pharma, Inc. is preparing to present key clinical milestones at two upcoming investment conferences, highlighting its novel antiviral candidates CC-42344 and CDI-988, with expected topline results from clinical trials in 2024 and 2025 [2][3]. Group 1: Upcoming Conferences - Cocrystal Pharma will participate in the Virtual Investor Summit Microcap Forum on August 20, 2024, and the H.C. Wainwright 26th Annual Global Investment Conference starting September 9, 2024 [1][3]. - The management will be available for in-person and virtual one-on-one meetings during the H.C. Wainwright conference, allowing institutional investors and industry professionals to engage directly [3]. Group 2: Clinical Milestones - The company anticipates reporting topline results in 2024 from its Phase 2a challenge study of the influenza A PB2 inhibitor CC-42344, with a final report expected in 2025 [2]. - Topline results from the Phase 1 trial of the oral protease inhibitor CDI-988, targeting norovirus and coronavirus infections, are expected in late 2024 or early 2025 [2]. Group 3: Product Candidates - CC-42344 is a broad-spectrum antiviral candidate designed to treat pandemic and seasonal influenza A, demonstrating favorable safety and pharmacokinetics in earlier studies [4]. - CDI-988 is a novel protease inhibitor aimed at treating norovirus and coronavirus infections, including SARS-CoV-2, currently undergoing a Phase 1 trial for safety and tolerability [5]. Group 4: Company Overview - Cocrystal Pharma, Inc. is a clinical-stage biotechnology company focused on developing antiviral therapeutics targeting influenza viruses, coronaviruses, noroviruses, and hepatitis C viruses using structure-based drug discovery technologies [6].

Financial Performance - The net loss for Q2 2024 was $5.3 million, or $0.54 per share, compared to a net loss of $4.2 million, or $0.41 per share in Q2 2023[11]. - The net loss for the first six months of 2024 was $9.3 million, or $0.91 per share, compared to a net loss of $9.4 million, or $1.03 per share in the first half of 2023[12]. - Net loss for the three months ended June 30, 2024, was $5,343,000, compared to a net loss of $4,166,000 for the same period in 2023, indicating a 28.2% increase in losses[16]. - Net loss per common share for the three months ended June 30, 2024, was $(0.53), compared to $(0.41) for the same period in 2023, representing a 29.3% increase in loss per share[16]. Research and Development - Research and development (R&D) expenses for Q2 2024 were $4.3 million, up from $2.8 million in Q2 2023, primarily due to the advancement of CC-42344 and CDI-988 into clinical studies[11]. - For the first six months of 2024, R&D expenses totaled $7.3 million, compared to $6.7 million for the same period in 2023[12]. - Research and development expenses increased to $4,308,000 for the three months ended June 30, 2024, compared to $2,801,000 for the same period in 2023, representing a 53.8% increase[16]. - Cocrystal expects to report topline results from the Phase 2a influenza A human challenge study in late 2024 or early 2025[2]. - The company plans to initiate a Phase 1 study in 2025 with inhaled CC-42344 as a potential influenza treatment and post-exposure prophylactic[2]. - Cocrystal anticipates reporting topline results from the CDI-988 Phase 1 study in late 2024 or early 2025[9]. Cash and Assets - As of June 30, 2024, unrestricted cash was $18.1 million, down from $26.4 million as of December 31, 2023[12]. - Total current assets decreased from $29,091,000 as of December 31, 2023, to $19,660,000 as of June 30, 2024, a decline of approximately 32.5%[15]. - Cash balance decreased from $26,353,000 as of December 31, 2023, to $18,143,000 as of June 30, 2024, a reduction of approximately 31.2%[15]. Operating Expenses - General and administrative (G&A) expenses for Q2 2024 were $1.1 million, down from $1.5 million in Q2 2023, mainly due to lower legal expenses[11]. - Total operating expenses for the three months ended June 30, 2024, were $5,448,000, up from $4,339,000 in the same period of 2023, reflecting a 25.6% increase[16]. Equity and Liabilities - Total liabilities decreased from $4,875,000 as of December 31, 2023, to $4,183,000 as of June 30, 2024, a decline of about 14.2%[15]. - Total stockholders' equity decreased from $26,384,000 as of December 31, 2023, to $17,390,000 as of June 30, 2024, a decline of approximately 34.1%[15]. Interest Income - Interest income increased to $151,000 for the three months ended June 30, 2024, compared to $140,000 for the same period in 2023, a rise of 7.9%[16]. Market Outlook - The global COVID-19 therapeutics market is estimated to exceed $16 billion by the end of 2031[10]. Share Information - Weighted average number of common shares outstanding increased to 10,174 for the three months ended June 30, 2024, compared to 10,065 for the same period in 2023[16].

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].

Core Insights - Cocrystal Pharma, Inc. reported positive safety and tolerability results from the Phase 1 study of CDI-988, a potent oral panviral protease inhibitor designed for norovirus and coronaviruses [1][2] - CDI-988 is positioned as a first-in-class oral treatment with a novel mechanism of action and broad-spectrum antiviral activity [2] - The Phase 1 study is being conducted in Australia, with participants receiving doses from 100 mg to 600 mg, and no serious adverse events were reported [2] Company Overview - Cocrystal Pharma, Inc. is a clinical-stage biotechnology company focused on developing antiviral therapeutics targeting influenza viruses, coronaviruses, noroviruses, and hepatitis C viruses [5] - The company utilizes structure-based technologies and Nobel Prize-winning expertise to create innovative antiviral drugs [5] Norovirus Context - Noroviruses are highly contagious and responsible for an estimated 21 million cases of acute gastroenteritis annually in the U.S., leading to significant healthcare burdens [3] - The annual economic impact of noroviruses in the U.S. is estimated at $10.6 billion, with outbreaks commonly occurring in semi-closed communities [3] Coronavirus Context - Coronaviruses can cause a range of symptoms, from mild to severe, including pneumonia and acute respiratory distress syndrome [4] - Cocrystal aims to develop effective treatments for all coronaviruses, including SARS-CoV-2 and its variants, by targeting viral replication enzymes and proteases [4]

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]

Antiviral Drug Development - Cocrystal Pharma is focused on developing novel antiviral therapeutics for serious viral diseases, utilizing structure-based technologies and Nobel Prize-winning expertise[78]. - The company has advanced oral CC-42344 to a Phase 2a clinical study for treating pandemic and seasonal influenza A, with 78 subjects enrolled and topline results expected in 2024[83]. - Cocrystal has developed inhaled CC-42344 for prophylactic treatment of influenza A, with plans to initiate a Phase 1 study in 2024[84]. - The company announced the selection of CDI-988 as a potential oral treatment for SARS-CoV-2 and norovirus, with Phase 1 clinical study results expected in 2024[86][89]. - Cocrystal is targeting the viral NS5B polymerase for HCV treatment, aiming for ultra-short treatment regimens of four to six weeks[105]. - The company has identified promising inhibitors for norovirus and is implementing successful antiviral program approaches[100]. - Cocrystal's antiviral candidates are designed to address significant unmet medical needs in viral infections, including those resistant to current treatments[92]. Market Opportunity - The global HCV market opportunity is significant, with an estimated 58 million people having chronic HCV infection as of July 2023[103]. - Influenza causes approximately 1 billion cases annually worldwide, leading to 3-5 million severe illnesses and up to 650,000 deaths[91]. - Norovirus is responsible for an estimated 21 million cases annually in the U.S., with a significant economic burden of $10.6 billion[99]. Financial Performance - Total research and development expenses for Q1 2024 were $2,950,000, a decrease of 24.5% from $3,907,000 in Q1 2023[109]. - Net loss for Q1 2024 was $3,956,000, compared to a net loss of $5,189,000 in Q1 2023, reflecting a 23.7% improvement[116]. - Interest income for Q1 2024 was $220,000, compared to $0 in Q1 2023, indicating a positive shift in cash management[111]. - Net cash used in operating activities increased to $4,503,000 in Q1 2024 from $3,111,000 in Q1 2023, primarily due to expenses related to clinical trials[117]. - The company had $21,842,000 in unrestricted cash as of March 31, 2024, sufficient to maintain operations for over the next 12 months[120]. - General and administrative expenses remained stable at $1,208,000 in Q1 2024 compared to $1,204,000 in Q1 2023[110]. - Foreign exchange loss decreased to $18,000 in Q1 2024 from $78,000 in Q1 2023, indicating improved currency management[114]. - The company has not yet established a source of revenue sufficient to cover operating costs, continuing to incur annual losses[121]. - The company plans to fund future operations through additional equity offerings and partnerships, highlighting ongoing capital needs[125]. Clinical Development and Partnerships - The company is seeking a partner for further clinical development of CC-31244 after completing Phase 2a trials[107].

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 ...