Research and Development - The company plans to advance the R&D of its product candidates to commercialization through studies and clinical trials, with anticipated costs and timelines yet to be determined[27]. - The company is focusing on the research and development of Lucid-MS to prevent and reverse myelin degradation, with the Lucid-21-302 clinical development program advancing towards human Phase 2 efficacy trials[27]. - The company is committed to maintaining a portfolio of strategic investments through FSD Strategic Investments Inc.[27]. - The company has made certain assumptions regarding securing additional licenses and entering into agreements for future product acquisitions[29]. - The company is focused on developing Lucid-MS, a patented new chemical entity targeting the treatment of multiple sclerosis (MS)[65]. - The company remains responsible for ensuring that product candidate drug trials comply with regulatory standards, despite reliance on third parties for research and development[83]. - Success in preclinical testing does not guarantee favorable results in later clinical trials, which could hinder regulatory approval[87]. - Product candidates may be associated with side effects that could delay or halt clinical development and regulatory approval[88]. - Regulatory authorities may require additional trials if undesirable side effects are identified post-approval, impacting the company's reputation and financial condition[90]. - The company may face challenges in identifying and licensing additional product candidates, which could adversely affect its business prospects[92]. Financial Position and Funding - The company believes its current financial position and recent operational improvements provide a solid foundation for operations and potential growth opportunities[27]. - The company is exploring near-term funding strategies to support its ongoing and planned clinical studies[27]. - The company anticipates significant losses for the foreseeable future as it pursues the commercialization of its Product Candidates[35]. - The company’s ability to raise additional capital on favorable terms is uncertain, which may impact its operational strategy[49]. - The company has a history of operating losses and negative cash flow, relying on equity, debt securities, and cryptocurrency activities for funding[211]. - The ability to continue as a going concern is uncertain, with potential challenges in raising additional capital on acceptable terms[212]. - Future capital raises may dilute existing shareholders and impose unfavorable terms, affecting the company's operations and financial condition[212]. Market Competition and Risks - The company faces significant competition for its drug candidate Lucid-MS, which may impact its market acceptance and commercial success[45]. - The company faces significant competition in the MS treatment market from established pharmaceutical companies and other biotechnology firms[78]. - The commercial success of Lucid-MS will depend on market acceptance by physicians, patients, and payors, as well as competitive pricing and manufacturing capabilities[76]. - The company is subject to various risks related to its intellectual property, including potential infringement claims that could delay development[46]. - The company may not achieve profitability even if Lucid-MS is approved, as market acceptance and competitive factors will significantly influence revenue generation[77]. - If approved, product candidates may face competition from generic drugs, which could impact market share and revenue[105]. - The company may face competition from generic drugs if competitors obtain marketing approval, potentially limiting demand and pricing for its products[108]. - Product liability lawsuits could lead to substantial liabilities, affecting the commercialization of product candidates[109]. Regulatory Environment - The company acknowledges the risks associated with its ability to conduct operations efficiently and the potential impact of regulatory changes on its business[32]. - The company operates in a highly regulated industry, and failure to comply with applicable laws could result in substantial penalties[49]. - The company's future success is heavily dependent on obtaining regulatory approval for its product candidates, which is a lengthy and uncertain process[67]. - The regulatory approval processes vary by country, and obtaining approval in one jurisdiction does not guarantee approval in others, potentially limiting market access[95]. - The company must comply with strict regulations regarding the production, storage, and use of controlled drugs, which could affect future research if resumed[155]. - The company is subject to various risks related to its intellectual property, including potential infringement claims that could delay development[46]. Cryptocurrency Holdings and Risks - The company’s treasury holdings in cryptocurrencies are subject to significant volatility, which could adversely affect its financial condition[49]. - The Company has pledged 18.32 Bitcoin units, valued at approximately US$1,601,865, as collateral for a US$1,000,000 loan facility with a 9% annual interest rate[161]. - The price of Bitcoin fluctuated between approximately $62,000 and $124,000 during the twelve-month period ending March 25, 2026, highlighting the extreme volatility of cryptocurrencies[164]. - The Company currently engages in staking with its Solana (SOL) holdings, which generates variable staking rewards subject to risks associated with the Solana network[160]. - The Company’s cryptocurrency holdings are accounted for at fair value, with changes in value recognized directly in the consolidated statement of loss, impacting reported net loss[175]. - The company’s cryptocurrency holdings currently represent approximately 45% of total unconsolidated assets, exceeding the 40% threshold under the Investment Company Act of 1940[197]. - The SEC has proposed amendments to custody rules that could impose additional regulatory requirements on the custody and storage of digital assets[183]. - The regulatory environment for cryptocurrencies remains uncertain, with potential changes from future executive actions or Congressional legislation[181]. - The company faces significant volatility and liquidity risks in its cryptocurrency investments, which may lead to substantial decreases in value over short periods[205]. - Cybersecurity risks could result in the permanent loss of cryptocurrency assets due to theft or technological failures[207]. - Fluctuations in cryptocurrency values may introduce volatility into the company's financial statements, directly affecting reported net losses[208]. - The company's cryptocurrency treasury activities divert management attention and resources from its core biopharmaceutical business, potentially slowing progress on drug development[210]. Operational Challenges - The company relies on third parties for conducting drug trials and aspects of research and preclinical testing, which may affect development timelines[45]. - The company expects to rely on third parties for drug supply storage and distribution, with potential performance failures leading to delays in clinical development[85]. - Failure of third parties to meet contractual duties could delay marketing approvals for product candidates, impacting commercialization efforts[84]. - Manufacturing problems at contract manufacturing organizations (CMOs) could lead to delays in clinical trials and increased costs[97]. - The company has no pharmaceutical products approved for commercial sale and has not generated any revenue from pharmaceutical product sales[65]. - The company lacks a comprehensive infrastructure for sales and marketing, which may hinder its ability to generate product revenue[115]. - Ongoing litigation regarding a breach of a nondisclosure agreement and trade secret misappropriation may impact the company's operations[128]. - The company has placed all research related to Lucid-PSYCH on hold due to funding issues as of April 2023[149]. - The company relied on a single-source supplier for drug substances and products for Lucid-PSYCH, which poses risks such as potential supply disruptions and increased costs[150]. - There is uncertainty regarding the approval of psychedelic drugs as medicines, with certain substances classified as Schedule I drugs under U.S. federal law, making medical use illegal[153]. - Delays in the drug substance and product manufacturing and supply chain may occur due to unforeseen problems with permitting and quota processes[156].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Ontario, Canada (Jurisdiction of incorpo ...

Women's Health Focus - Daré Bioscience focuses on women's health, aiming to close gaps in care with science-backed solutions across various areas including contraception and menopause [19]. - The company plans to explore opportunities for portfolio expansion through acquisitions and in-licensing of new programs that address unmet needs in women's health [34]. Product Development and Launches - The first product in the DARE to RESTORE™ line, Flora Sync LF5™, is expected to launch in the U.S. in Q2 2026, aligning with the company's vision for integrating evidence-based products into women's health [26]. - DARE to RECLAIM estradiol progesterone intravaginal ring is expected to be available for prescription fulfillment in early 2027, targeting a non-oral, monthly hormone therapy option for menopausal symptoms [47]. - The DARE to RESTORE product line, including vaginal probiotic suppositories, is expected to launch in the U.S. in Q2 2026, with a focus on supporting vaginal microbiome balance [52]. - DARE to PLAY Sildenafil Cream is set to begin pharmacy dispensing and revenue recording in Q2 2026, following a Phase 2b clinical study that was the first to evaluate a therapy for female sexual arousal disorder [43]. Clinical Trials and Research - Daré's product candidates are at various development stages, including Ovaprene®, currently in a pivotal Phase 3 clinical study, and DARE-HRT1, designed for menopausal hormone therapy [32]. - The pivotal Phase 3 clinical study aims to enroll approximately 250 participants to complete about 12 months (13 menstrual cycles) of use, with recruitment initiated in 2025 [69]. - The Phase 3 program for Sildenafil Cream received FDA alignment on key elements, confirming FSAD as an acceptable indication and allowing for a 12-week blinded treatment period [90]. - The Phase 1 clinical trial of DARE-HRT1 showed that both versions of the IVR released estradiol and progesterone in normal ranges, with no serious adverse events reported [98][99]. Financial Strategies and Funding - Daré aims to reduce reliance on dilutive capital by pursuing a capital-efficient commercialization path, leveraging direct-to-consumer marketing and strategic partnerships [28]. - The company has received non-dilutive funding from U.S. federal agencies and private foundations to support various research and development activities across eight programs [36]. - The company is responsible for providing $5.5 million to NICHD for a Phase 3 clinical study of Ovaprene, with all funds paid as of September 30, 2024 [157]. Licensing and Partnerships - The company has entered into a licensing agreement with Organon for XACIATO, which was approved by the FDA in December 2021 and is now available nationwide as of January 2024 [30]. - The company entered into a co-development and licensing agreement with Theramex for the biodegradable contraceptive implant Casea S, with no current development costs [145][146]. - The company entered into a license agreement with Hennepin Life Sciences LLC in August 2022, acquiring exclusive global rights to develop and commercialize treatments using antimicrobial glycerol monolaurate (GML) for various health conditions [151]. Product Efficacy and Safety - The clinical trial for Ovaprene met its primary endpoint, showing that it prevented the requisite number of sperm from reaching the cervix in 100% of women and cycles evaluated [66]. - Preliminary efficacy data from the Phase 1/2 study of DARE-HRT1 indicated significant improvements in vaginal health and menopausal symptoms, with p-values <0.01 for all measured outcomes [102][103]. - DARE-VVA1, a hormone-free treatment for moderate-to-severe dyspareunia, has shown significant improvements in vaginal pH (approximately 30%) and dryness scores (approximately 63%) after three months of treatment [113]. Market Positioning and Consumer Access - The product is positioned as a science-backed, evidence-driven solution for women's sexual health, with clinical data showing increased genital blood flow within 10-15 minutes of application [42]. - DARE to PLAY is currently offered on a cash-pay basis only, with no insurance coverage or reimbursement options available [46]. - The company has partnered with Bravado Pharmaceuticals for the manufacturing and fulfillment of DARE to PLAY prescriptions, ensuring compliance with state-level pharmacy regulations [44]. Future Development Plans - The company plans to utilize the FDA's 505(b)(2) pathway for DARE-HRT1 marketing approval, supported by a single Phase 3 clinical trial [95]. - The company is exploring strategic collaborations to expand the application of its DARE-IDDS platform beyond contraception [134]. - The ongoing Phase 1 study of Casea S is being conducted with no development costs to the company at this time [131].

Financial Performance and Funding - The company has incurred significant operating losses since inception, with expectations of continued losses for the foreseeable future[22] - The company may require substantial additional funding, which may not be available on acceptable terms[22] - Shareholders may not receive dividends in the foreseeable future, limiting their return on investment to potential appreciation in share price[47] - The company may encounter difficulties in completing equity offerings due to limitations on preferential subscription rights for existing shareholders[50] Product Development and Regulatory Risks - The company is substantially dependent on the success of its only product candidate, GLPG3667, for future revenue generation[27] - The regulatory approval processes for product candidates are lengthy and unpredictable, which may affect commercial viability[29] - Clinical trials may reveal adverse events that could inhibit regulatory approvals or market acceptance of product candidates[35] - The company relies on third parties for conducting preclinical studies and clinical trials, which poses risks to obtaining regulatory approval[37] Collaboration and Competition - The company is heavily reliant on global collaboration agreements with Gilead for product development and commercialization, with no assurance of expected benefits[36] - The company faces significant competition in drug discovery and development, which could reduce commercial opportunities[34] Tax and Foreign Exchange Risks - The company may be classified as a passive foreign investment company (PFIC) for U.S. federal income tax purposes, which could lead to adverse tax consequences for certain U.S. holders[42] - The company believes it was not a controlled foreign corporation (CFC) for U.S. federal income tax purposes, but qualifying as a CFC could result in negative tax implications for certain U.S. holders[43] - The company may face significant foreign exchange risk, particularly with fluctuations between the U.S. dollar and the euro[44][46] Market and Shareholder Considerations - The market price of the American Depositary Shares (ADSs) could experience wide fluctuations, impacting shareholder value[45] - As a foreign private issuer, the company is exempt from certain U.S. securities laws, which may limit the information available to ADS holders[51] - The company may lose its foreign private issuer status in the future, potentially resulting in significant additional costs[52] Operational Challenges - The wind-down of cell therapy activities may not be completed in a timely manner or on favorable terms[23] - The ability to successfully implement business development strategies is critical for acquiring and commercializing product candidates[26]

Financing and Capital - The company has raised a total of €310.6 million in equity financing since inception, including €103.6 million from an IPO on Euronext in September 2020 and €75.0 million from an IPO on Nasdaq in July 2021[678]. - The company plans to file a new shelf registration statement on Form F-3 on March 20, 2025, to register the offer and sale of up to $200.0 million of its securities[678]. - Net cash from financing activities decreased to €38.1 million in 2025 from €77.4 million in 2024, reflecting several capital increases during the year[682]. Financial Position - As of December 31, 2025, the company reported cash and cash equivalents of €30.0 million and an accumulated deficit of €305.6 million[688]. - The company has significant contractual obligations totaling €27.96 million in financial debt and €15.49 million in trade and other liabilities due within one year[690]. Operating Performance - Net cash used in operating activities increased to €68.0 million in 2025 from €49.2 million in 2024, primarily due to higher research and development expenses[680]. - The company expects to incur operating losses and generate negative cash flows due to ongoing investments for the U.S. commercial launch and clinical trials, with cash runway extending into Q1 2027[689]. - The company has consistently operated with deficits and sustained negative cash flows since inception, primarily due to high research and development costs for the Genio device[688]. Research and Development - Research and development expenses are expected to decrease in the near term due to the closure of the Israel R&D department and reduced costs related to clinical studies[687]. Currency Risk - The company is minimally exposed to currency risk, with potential impacts on net loss from fluctuations in USD, NIS, and AUD against the Euro[929].

Financial Performance - Revenues for the year ended December 31, 2025, were $22,402,188, a decrease of 15% from $26,350,819 in 2024, primarily due to external headwinds including government shutdowns and reduced Department of Defense funding [105]. - Gross profit decreased by 22% to $15,202,626 for 2025, with a gross profit margin of 68%, down from 74% in 2024, attributed to lower revenues and increased cost of sales [107]. - Net income for 2025 was $258,446, representing an 81% decrease from $1,363,681 in 2024, driven by the decline in revenue [112]. - Adjusted EBITDA for 2025 was $1,601,152, a decrease of 45% from $2,926,169 in 2024, reflecting the overall decline in financial performance [113]. Operating Expenses - Operating expenses decreased by 15% to $14,765,131 in 2025, with general and administrative expenses down by 14% and research and development expenses down by 21% [109]. Cash Flow - Cash and cash equivalents increased to $18,594,598 as of December 31, 2025, compared to $18,040,827 in 2024, indicating improved liquidity [114]. - Net cash provided by operating activities rose significantly to $4,587,967 in 2025, up from $1,257,266 in 2024, due to better collection of accounts receivable [115]. - Net cash used in investing activities increased to $3,780,744 in 2025, driven by the creation of an intangible asset for the VXR product and additional property purchases [116]. - Net cash used in financing activities was $253,452 for the year ended December 31, 2025, compared to $220,709 for the year ended December 31, 2024 [117]. Product and Market Strategy - The company plans to broaden its product offerings and leverage advancements in artificial intelligence to enhance training realism and reduce development costs [104]. - The V-300™ simulator features a 300-degree immersive training environment, emphasizing the importance of quick judgment decisions in high-stress scenarios [104]. Bookings and Backlog - Total bookings for the year ended 2025 reached $26.7 million, with $7.3 million booked in the fourth quarter [118]. - The company's backlog as of December 31, 2025, totaled $25.6 million, comprising $13.8 million in Capital, $5.1 million in Service, and $6.7 million in STEP [119]. - Management estimates that the majority of new bookings received in Q4 2025 will convert to revenue in 2026 [120]. - The company believes there are $2.5 million in renewable STEP contract options outstanding, with an expected 95% exercise rate based on current renewal rates [118]. Capital Resources - Current capital resources are deemed adequate for operations for more than 12 months, but the company is open to raising additional funds for expansion and market opportunities [122]. Accounting Policies - The company has adopted ASC 606 for revenue recognition, which did not significantly affect its financial statements upon adoption [130]. - Revenue includes product sales and services, net of discounts, with significant components being simulators and related services [131]. - The company provides a one-year assurance-type warranty on products, estimating warranty liabilities based on historical claims [139]. - As of December 31, 2025, there were no off-balance sheet arrangements that materially affect the company's financial condition [141].

Financial Performance - Daré Bioscience reported approximately $24.7 million in cash and cash equivalents as of December 31, 2025, with working capital of approximately $3.4 million[18]. - Total revenue for 2025 was $1,030,193, a significant increase from $9,784 in 2024[37]. - Operating expenses for 2025 totaled $14,286,728, down from $23,461,269 in 2024, indicating a reduction in costs[37]. - The net loss for 2025 was $13,399,274, compared to a net loss of $4,053,599 in 2024, reflecting increased operational challenges[37]. - Cash and cash equivalents increased to $24,711,356 in 2025 from $15,698,174 in 2024, showing improved liquidity[39]. - Total assets rose to $32,474,563 in 2025, up from $22,101,131 in 2024, indicating growth in the company's asset base[39]. - The company reported a loss per common share of $1.20 for 2025, compared to $0.48 in 2024, highlighting increased losses on a per-share basis[37]. Funding and Expenses - The company received approximately $20.8 million in net proceeds from equity offerings during 2025, alongside significant non-dilutive funding totaling approximately $16.4 million from various grants[19][22]. - Selling, general and administrative expenses for 2025 were approximately $8.8 million, a decrease from approximately $9.2 million in 2024[20]. - Research and development expenses were approximately $5.5 million for 2025, down from approximately $14.3 million in 2024, with total contra-R&D expenses related to grant funding at approximately $16.4 million[21]. - Daré plans to advance the development of product candidates with non-dilutive grant funding, aiming to reduce reliance on equity financing[32]. Product Development and Strategy - Daré expects to begin recording product revenue from DARE to PLAY and Flora Sync LF5 in Q2 2026, with revenue from DARE to RECLAIM targeted to begin in 2027[23]. - DARE to PLAY is a topical sildenafil cream for women, designed to increase genital blood flow within 10 to 15 minutes, addressing a market of approximately 20 million women in the U.S. experiencing arousal challenges[3][4]. - The company is advancing DARE-HPV into a Phase 2 clinical study with ARPA-H funding, aiming to address high-risk HPV infections affecting approximately 6 million women annually in the U.S.[14][13]. - DARE to RECLAIM, a monthly bio-identical hormone therapy product, is expected to be available for prescription fulfillment in early 2027, targeting a market valued between $2.5 billion and $4.5 billion[9][10]. - The company is pursuing a dual-path strategy for DARE to PLAY, making it available as a compounded product while also advancing it toward the 505(b)(2) NDA pathway[8]. - Daré is building a multi-product revenue profile, with expectations for diversified growth across 2026 and 2027[23]. - The company is focused on launching new consumer health products, including Flora Sync LF5, as part of its commercial strategy[32]. - Daré aims to pursue FDA approval for its drug product candidates, which may strengthen their market position as 503B compounded products[32]. Leadership and Recognition - The leadership has been recognized for contributions to innovation in women's health, enhancing the company's reputation in the biopharma sector[29].

Financial Performance - For the year ended December 31, 2025, the company reported a net income of $233,000, a significant improvement from a net loss of $2.0 million in 2024[228]. - Net income for 2025 was $232,690, compared to a net loss of $1.96 million in 2024, indicating a significant turnaround in profitability[266]. - The company reported a comprehensive income of $5.24 million in 2025, compared to a comprehensive loss of $1.93 million in 2024, indicating a significant improvement[266]. - Net cash flows from operating activities improved to $1,245,094 in 2025, compared to $(2,774,524) in 2024[270]. - Net interest income for the year ended December 31, 2025, was $14.1 million, compared to $9.7 million in 2024, reflecting an increase in the net interest margin to 3.24% from 2.38%[224]. Asset and Equity Growth - Total assets increased by $39.9 million, or 8.9%, to $489.4 million as of December 31, 2025, compared to $449.5 million as of December 31, 2024[213]. - Total equity surged by $75.6 million, or 88.0%, to $161.4 million as of December 31, 2025, driven by net capital raised during the IPO of $79.4 million[221]. - Cash and cash equivalents rose by $32.3 million, or 210.5%, to $47.6 million as of December 31, 2025, primarily due to the initial public offering completed on December 3, 2025[214]. - The company’s total stockholders' equity rose to $161.37 million in 2025, up from $85.83 million in 2024, an increase of about 87.8%[264]. Loan Portfolio and Credit Quality - Loans receivable, net increased by $27.0 million, or 11.2%, to $267.9 million as of December 31, 2025, reflecting efforts to grow the commercial loan portfolio[216]. - The provision for credit losses rose by $72,000, or 15.4%, to $540,000 in 2025, reflecting management's assessment of the growing loan portfolio[231]. - Loans over 90 days delinquent decreased to approximately $444,000 in 2025 from approximately $1,661,000 in 2024, a decline of about 73.3%[322]. - The total loans receivable increased to $276,340,634 in 2025 from $248,204,263 in 2024, representing an increase of approximately 11.3%[321]. - The allowance for credit losses rose to $2,681,819 in 2025, compared to $2,125,993 in 2024, indicating a 26.1% increase[321]. Deposits and Funding - Deposits decreased by $35.7 million, or 10.0%, to $321.6 million as of December 31, 2025, with certificates of deposit declining by $31.6 million due to the interest rate environment[220]. - Total deposits decreased from $357.3 million in 2024 to $321.6 million in 2025, a decline of approximately 10%[336]. - Certificates of deposit fell from $192.9 million in 2024 to $161.2 million in 2025, representing a decrease of about 16.5%[336]. - The Bank had commitments to lend approximately $48.7 million in 2025, up from $33.2 million in 2024, an increase of about 46.5%[341]. Noninterest Income and Expenses - Noninterest income increased by $140,000, or 13.0%, to $1.2 million in 2025, mainly due to higher gains on real estate sales[232]. - Noninterest expense grew by $1.4 million, or 10.8%, to $14.7 million in 2025, influenced by a one-time contribution of $1.9 million to establish a charitable foundation[233]. - The company expects noninterest expenses to rise as operations expand, particularly due to new stock benefit plans[202]. Regulatory and Capital Ratios - As of December 31, 2025, the company maintained a Tier 1 capital ratio of 24.8%, significantly exceeding the regulatory requirement[247]. - The Bank's Tier 1 capital to average assets ratio was 24.8% as of December 31, 2025, significantly exceeding the required minimum of 9.0%[372]. - The Bank's net worth exceeded regulatory capital requirements as of December 31, 2025, maintaining its classification as well capitalized[367]. Investment Securities - Investment securities available-for-sale decreased by $9.9 million, or 8.5%, to $106.7 million as of December 31, 2025, with liquidity used to fund the loan portfolio[215]. - The total available-for-sale securities decreased in fair value to $106,653,763 in 2025 from $116,554,742 in 2024, a decline of approximately 8.5%[315]. - The gross unrealized losses on available-for-sale securities amounted to $15,283,348 in 2025, compared to $22,263,503 in 2024, a reduction of approximately 31.4%[316]. Miscellaneous - The company reported a contribution of $1,869,380 to the charitable foundation in 2025[270]. - The Bank established a loan production office in Oak Park, Illinois in 2023 to enhance its market presence[272]. - The Bank's advertising expense increased to $95,475 in 2025 from $61,975 in 2024[308]. - The Bank's segment performance is evaluated using consolidated net income (loss), with all operations being domestic[314].

Financial Performance and Capital Needs - The company has incurred significant operating losses since its inception, with an accumulated deficit of approximately $154.6 million as of December 31, 2025[207]. - The company expects to continue incurring substantial operating losses over the next several years as it develops and seeks regulatory approval for its product candidate, elraglusib[207]. - As of December 31, 2025, the company had approximately $13.2 million in cash and cash equivalents, with working capital of approximately $7.9 million, which is projected to be insufficient beyond July 2026[211]. - The company anticipates needing substantial additional capital to finance its operations and may seek funding through public or private equity, debt financings, or strategic partnerships[212][213]. - The independent registered public accounting firm has expressed substantial doubt about the company's ability to continue as a going concern[214]. Product Development and Regulatory Risks - The company relies entirely on the success of elraglusib, which is currently in Phase 2 clinical development for mPDAC, making its business highly dependent on this single product candidate[218]. - The company faces significant risks in obtaining regulatory approvals, which are essential for the commercialization of elraglusib, and any delays could materially harm its business[221][222]. - The company has no approved products on the market and may never achieve profitability if it fails to successfully develop and commercialize elraglusib[221]. - The company acknowledges that the drug development process is lengthy, expensive, and fraught with uncertainty, with a high historical failure rate for product candidates in the biopharmaceutical industry[226]. - The company has not yet demonstrated an ability to overcome the risks and uncertainties associated with biopharmaceutical product development, which complicates its ability to predict future expenses and profitability[210]. - Elraglusib has received Fast Track designation from the FDA for the treatment of pancreatic cancer, which may facilitate the review process but does not guarantee marketing approval[247]. - The company has not yet initiated or completed a Phase 3 clinical trial, which is critical for obtaining FDA approval for elraglusib or any future product candidates[239]. - The company may face significant setbacks in clinical development despite promising early results, as many product candidates fail in later trials[228]. - Enrollment delays in clinical trials could materially affect the company's financial condition and development timelines[238]. - The company may need to conduct additional preclinical studies or clinical trials based on negative or inconclusive results, leading to increased operating expenses and delays[229]. Manufacturing and Supply Chain Challenges - The company relies on a single manufacturer in China for elraglusib's drug substance, and geopolitical factors could impact supply and costs[266]. - The company currently has a sole source manufacturer for the drug substance of elraglusib, which poses risks of supply disruption[278]. - There are no long-term supply agreements in place with suppliers, which could delay clinical trials if supplies are not sourced timely[271]. - The company may face challenges in obtaining regulatory approvals for manufacturing facilities, which could significantly affect product development[270]. - Geopolitical tensions with China could impact the company's ability to conduct clinical trials if relying on Chinese vendors[279]. - The company has limited control over third-party manufacturers' compliance with quality standards, which could affect product quality[269]. - The company is dependent on third parties for conducting clinical trials, which could lead to delays if these parties do not meet their obligations[273]. Intellectual Property Risks - Intellectual property rights may not be enforceable in certain foreign jurisdictions, potentially allowing competitors to exploit the company's innovations[281]. - The company has filed several new composition of matter patent applications for elraglusib, which could expire in 2038, with potential for patent term extensions[283]. - Patent applications in the pharmaceutical and biotechnology sectors may be limited in scope, potentially reducing competitive protection[285]. - The company faces risks of patent expirations, which could diminish competitive advantages and product value[286]. - Trade secrets and proprietary know-how are critical for maintaining competitive position, but their protection is uncertain[287]. - Intellectual property claims may not sufficiently prevent competitors from developing similar products, impacting financial performance[288]. - The company may incur significant costs and time in addressing intellectual property disputes, which could adversely affect business operations[289]. - Changes in patent laws could weaken the company's ability to protect its intellectual property and affect its commercial value[293]. - Patent terms are limited to generally 20 years, which may not provide adequate protection for product candidates like elraglusib[294]. - The company may face claims challenging the inventorship or ownership of its patents, which could result in loss of valuable intellectual property rights[296]. - Third-party intellectual property rights could hinder the commercialization of current or future technologies, requiring potential litigation or licensing[299]. - Infringement claims could lead to substantial damages or force the company to abandon technologies, impacting financial condition and operations[300]. - The company may face claims regarding the wrongful use or disclosure of trade secrets by employees or consultants, which could lead to litigation and substantial costs[301]. - Intellectual property rights may be subject to federal regulations due to government funding, potentially limiting exclusive rights and requiring compliance with reporting requirements[303]. - The U.S. government may have rights to inventions developed under government-funded programs, including the ability to require licensing to third parties if commercialization steps are inadequate[304]. Compliance and Operational Risks - Compliance with healthcare laws and regulations may increase operational costs and expose the company to significant penalties if found in violation[305]. - Strategic transactions, such as acquisitions or partnerships, may incur non-recurring charges and increase near- and long-term expenditures, posing integration challenges[308]. - Cybersecurity incidents could disrupt development programs and compromise sensitive information, potentially leading to significant costs and reputational damage[311]. - The company relies on third-party vendors for IT infrastructure, which may expose it to vulnerabilities if those vendors fail to protect confidential information[313]. - Non-compliance with health privacy and data protection laws could result in government enforcement actions, private litigation, and damage to the company's reputation[315]. - The evolving legal framework around privacy issues may impose new obligations and restrictions on data collection and usage, impacting operational capabilities[318]. - Disruptions at the FDA and other government agencies due to funding shortages and personnel changes could delay the approval and commercialization of new products, negatively impacting the company's business[319]. - The FDA postponed most inspections during the COVID-19 pandemic, and future global health concerns may lead to similar delays, significantly affecting the company's regulatory submissions[320]. - The company's lead drug development program, elraglusib, will be reviewed by the FDA's Center for Drug Evaluation and Research (CDER), which is known for demanding high-quality clinical research[321]. - The company lacks in-house expertise in drug approvals and may rely on consultants, which poses risks of delays and increased expenses in the drug approval process[322]. Stock and Corporate Governance Risks - Approximately 43% of the company's common stock is held by funds affiliated with the chairman, potentially limiting other stockholders' influence and creating conflicts of interest[324]. - The company has never declared or paid cash dividends and does not intend to do so in the foreseeable future, relying on stock price appreciation for returns[331]. - The trading price of the company's common stock is likely to be highly volatile, influenced by clinical trial results, regulatory approvals, and market conditions[329]. - The company may face challenges in maintaining compliance with Nasdaq listing requirements, which could lead to delisting and negatively impact stock price[327]. - The company's amended and restated bylaws contain provisions that could make mergers or proxy contests difficult, potentially depressing stock value[332]. - The company is subject to anti-takeover provisions under Delaware law, which may limit business combinations with significant stockholders[335]. - The company faces significant risks due to unstable market and economic conditions, which may adversely affect its ability to raise funds and could lead to operational delays[338]. - The company is at risk of declining stock price and trading volume if analysts downgrade its stock or cease coverage, impacting investor interest[339]. - The company must maintain effective internal control over financial reporting to ensure accurate financial statements; failure to do so could lead to a decline in stock price and investor confidence[340]. - If the company cannot demonstrate effective internal controls, it may face sanctions from regulatory authorities, which could restrict future access to capital markets[341]. - The company is classified as a "smaller reporting company" and is not required to provide certain market risk disclosures[417].

Currency and Inflation Impact - The appreciation of the NIS against the U.S. dollar was 12.5%, 0.6%, and 3.1% for the years ended December 31, 2025, 2024, and 2023, respectively, which may negatively impact financial results [153]. - The Israeli annual rate of inflation was 3.0%, 3.2%, and 2.6% for the years ended December 31, 2023, 2024, and 2025, respectively [153]. - The company has not maintained a program to hedge against foreign currency exchange rate fluctuations, which could affect financial results [153]. Grants and Royalties - The company received approximately $9.6 million in royalty-bearing grants from the Israeli Innovation Authority, with a repayment of approximately $4.4 million in royalties [156]. - The company is committed to paying royalties at a rate of 3.0% - 4.0% on sales proceeds from products developed under IIA programs [155]. - The company may face difficulties in transferring know-how and manufacturing rights outside of Israel due to restrictions from IIA grants [156]. Compliance and Listing Requirements - A reverse share split of 1-for-10 was executed on July 24, 2024, to regain compliance with Nasdaq listing requirements [166]. - As of March 12, 2026, the trading price for the ordinary shares was $0.94, below the $1.00 minimum bid price requirement [166]. - The company received a notification from Nasdaq on September 18, 2023, for non-compliance with the minimum bid price requirement [165]. Market and Trading Conditions - The market price of the ordinary shares may fluctuate significantly due to various factors, including financial performance and market conditions [161]. - The company is listed on both the TASE and Nasdaq, which may lead to price variations due to trading in different currencies and time zones [171]. Financial Reporting and Compliance Costs - The company incurs significant accounting, legal, and compliance costs as a public company, which may adversely affect its financial condition and results of operations [174]. - As a foreign private issuer, the company is exempt from certain U.S. reporting requirements, which may limit the information available to investors compared to U.S. domestic issuers [175]. - The company may lose its foreign private issuer status, resulting in increased compliance costs and more extensive reporting obligations under U.S. securities laws [177]. Tax Implications for Shareholders - The company believes it was a Passive Foreign Investment Company (PFIC) for U.S. federal income tax purposes in 2025, with risks of being classified as such in 2026, which could lead to adverse tax consequences for U.S. shareholders [179]. - U.S. shareholders may face adverse tax consequences if the company is classified as a PFIC, including gains being treated as ordinary income rather than capital gains [180]. Internal Control and Financial Reporting - The company may experience difficulties in maintaining effective internal control over financial reporting, which could negatively impact the price of its ordinary shares [181].