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].

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].

Core Viewpoint - Cocrystal Pharma is advancing its antiviral product pipeline targeting norovirus, influenza, and coronaviruses, addressing significant gaps in global health with no current effective treatments or vaccines [2][3]. Antiviral Product Pipeline Overview - The company utilizes a proprietary structure-based drug discovery platform to develop broad-spectrum antivirals that inhibit viral replication, aiming for effectiveness against various viral mutations while minimizing side effects [4]. Influenza Programs - Influenza poses a major global health threat, with approximately 1 billion cases and up to 650,000 deaths annually. The economic impact in the U.S. is estimated at $11.2 billion each year [5]. - The oral PB2 inhibitor CC-42344 has shown promising in vitro activity against seasonal and pandemic influenza A strains, including those resistant to existing antivirals [5]. - A Phase 2a human challenge study for CC-42344 was initiated in December 2023, with enrollment completed by May 2024. The study is being extended due to unexpectedly low infection rates among participants [5][9]. Norovirus Program - Norovirus causes an estimated 685 million cases and 50,000 child deaths globally each year, with a societal cost of $60 billion. The company aims to develop effective treatments targeting all genogroups of norovirus [7]. SARS-CoV-2 and Other Coronavirus Programs - Cocrystal is developing treatments targeting viral replication enzymes for coronaviruses, including SARS-CoV-2. The global COVID-19 therapeutics market is projected to exceed $16 billion annually by 2031 [8]. Financial Results - For 2024, research and development expenses were $12.5 million, down from $15.2 million in 2023, primarily due to clinical study cost timing. General and administrative expenses decreased to $5.3 million from $6.0 million [9]. - The net loss for 2024 was $17.5 million, or $1.72 per share, compared to a net loss of $18.0 million, or $1.87 per share in 2023 [10]. - As of December 31, 2024, the company reported unrestricted cash of $9.9 million, down from $26.4 million a year earlier, with net cash used in operating activities increasing to $16.5 million from $14.7 million [13].

Core Points - Cocrystal Pharma, Inc. will participate in a fireside chat at the Zacks SCR Life Sciences Virtual Investor Forum on March 13, 2025 [1] - The event will be hosted by Zacks Small Cap Research Senior Analyst David Bautz, PhD [1] Company Overview - Cocrystal Pharma, Inc. is a clinical-stage biotechnology company focused on discovering and developing novel antiviral therapeutics targeting the replication of various viruses, including influenza, coronaviruses (such as SARS-CoV-2), noroviruses, and hepatitis C [4] - The company utilizes unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs [4]

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].