Financial Performance - The company incurred net losses of 5.1 million for the years ended December 31, 2024 and December 31, 2023, respectively, with an accumulated deficit of 1.2 million, raising substantial doubt about its ability to continue as a going concern[215]. - The company has never generated any revenue from product sales and does not anticipate doing so for the foreseeable future[210]. - Future net losses will depend on the rate of expenditures and the ability to obtain funding through equity or debt financings, strategic collaborations, or grants[206]. - The company expects to continue incurring significant expenses and increasing operating losses as it expands research and clinical development[208]. Product Development and Regulatory Challenges - The company has not yet commenced pivotal clinical studies for any product candidate, and it may take several years before any product candidate is approved for commercialization[206]. - The regulatory approval process for RNAi-based therapeutics is complex and uncertain, which may lengthen the timeline for product candidates[226]. - The company has concentrated its efforts on RNAi technology, which is unproven for oncology and may never lead to marketable products[223]. - The company may be required to change its product development strategy if it is not successful in developing a product candidate using RNAi technology[227]. - The company has invested significantly in developing product candidates, including preclinical and clinical studies, but currently generates no revenue from drug sales[228]. Clinical Trials and Patient Recruitment - The first-generation Loder Phase II study has concluded, and the company plans to initiate the next clinical trial with SIL204 for locally advanced pancreatic cancer in the first half of 2026[229]. - Patient recruitment for clinical studies may be challenging, particularly for rare diseases like pancreatic cancer, which had approximately 61,000 diagnoses in the U.S. in 2020[241]. - Clinical drug development is expensive and time-consuming, with a high failure rate in later-stage studies despite promising early results[237]. Regulatory Compliance and Risks - The company must comply with varying regulatory requirements across jurisdictions, and success in one does not guarantee success in others[231]. - Undesirable side effects from product candidates could delay or prevent regulatory approval and impact market acceptance[244]. - If approved, products will be subject to ongoing regulatory scrutiny and may require post-marketing studies to confirm safety and efficacy[248]. - Regulatory authorities may impose restrictions or withdraw approvals if unknown problems arise post-approval, significantly affecting the company's operations[252]. - The company has never produced a commercially approved pharmaceutical product and lacks the necessary regulatory authority approvals[254]. Manufacturing and Supply Chain Risks - The company relies on third-party manufacturers for raw materials and products, increasing the risk of supply disruptions and quality issues[266]. - The company does not currently have the infrastructure to produce product candidates at commercial levels and has not entered into binding agreements with manufacturers for commercialization[271]. - Manufacturing processes are complex and highly regulated, with risks including contamination and equipment failure that could disrupt supply[260]. Market Competition and Commercialization - The biotechnology and pharmaceutical industries are highly competitive, with numerous existing therapies that may compete with the company's product candidates[274]. - The company currently lacks a marketing and sales organization, which is essential for generating revenue from product candidates[276]. - The company may face challenges in estimating the size of the required sales force for effective commercialization, potentially leading to excess costs[277]. - The market acceptance of Silexion's product candidates will depend on factors such as safety, efficacy, pricing, and reimbursement availability[281]. - The company faces significant risks related to the competitive landscape, particularly in the RNAi therapeutic space, which may become more competitive[280]. Intellectual Property and Patent Risks - The company has pending PCT applications for patent protection in multiple international jurisdictions, which is crucial for maintaining a competitive edge[299]. - The ability to obtain and maintain effective patent rights is essential for the company to compete effectively in its markets[299]. - The company faces significant uncertainties regarding its patent applications, which may not result in issued patents that adequately cover its product candidates[302]. - The natural expiration of patents in the United States is generally 20 years after filing, and the company may not have sufficient patent terms to protect its products effectively[306]. - The company may encounter earlier-than-expected competition from generic and biosimilar manufacturers due to challenges against its patents[308]. Financial and Market Risks - The company received two letters from Nasdaq regarding non-compliance with listing requirements, specifically a Market Value of Listed Securities (MVLS) below 15 million[366]. - The company has outstanding amounts under the A&R Sponsor Promissory Note totaling $3,433,000, which could lead to further dilution of existing shareholders[374]. - The company’s ordinary shares and warrants may experience significant price volatility due to various factors, including market conditions and operational results[370]. - The company may consider transferring its listing to the Nasdaq Capital Market if it meets the necessary requirements, but there is no assurance of qualifying for such a transfer[367]. Operational and Strategic Risks - The company may face challenges in enforcing non-competition agreements with former employees, potentially impacting its competitive position[363]. - The company is at risk of economic boycotts and restrictive laws that could adversely affect its operating results and expansion efforts[358]. - Strategic alliances and acquisitions may present unforeseen integration challenges and could divert management's focus from ongoing operations[351]. - The company may face significant product liability risks, which could lead to substantial liabilities and limit commercialization of approved products[346]. Miscellaneous Risks - Cybersecurity risks are increasing, with potential disruptions to operations that could materially affect research and development programs and financial results[344]. - Political instability in Israel may adversely impact the company’s operations and financial condition, as it has faced multiple elections and judicial changes since 2019[361]. - Conditions in the Middle East, including armed conflicts, may pose risks to the company's operations in Israel[354].
Silexion Therapeutics Corp(SLXN) - 2024 Q4 - Annual Report