Silexion Therapeutics (SLXN) risk factors, FY2024 10-K

Risks Related to Our Financial Condition and Capital Requirements

1. 01We are a development-stage company and have a limited operating history on which to assess our business. We have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future
2. 02We have never generated any revenue from product sales and may never be profitable
3. 03attracting, hiring, and retaining qualified personnel
4. 04the terms and timing of any collaborative, licensing, and other arrangements that we may establish
5. 05The historical financial results included in this Annual Report and our unaudited pro forma financial information included in our recent prospectuses may not be indicative of what our actual financial position or results of operations would have been

Risks Related to the Research and Development of Silexion’s Product Candidates

1. 06The approach we are taking to discover and develop novel RNAi therapeutics is unproven for oncology and may never lead to marketable products
2. 07We are heavily dependent on the success of our product candidates, which are in the early stages of preclinical or clinical development. We cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized
3. 08The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming, and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed
4. 09the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval
5. 10Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of preclinical activity or earlier studies may not be predictive of future study results
6. 11failures associated with data interpretation, data management and data storage of such studies
7. 12We may find it difficult to enroll patients in our clinical studies. Difficulty in enrolling patients could delay or prevent clinical studies of our product candidates
8. 13If patients are unwilling to participate in our studies for any reason, the timeline for recruiting patients, conducting studies, and obtaining regulatory approval of our potential products will be delayed
9. 14Our reputation may suffer
10. 15Even if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory scrutiny
11. 16seize or detain products, or require a product recall
12. 17The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses
13. 18We and our collaborators are subject to significant regulation with respect to manufacturing our product candidates. The facilities we subcontract to for manufacturing may not meet regulatory requirements and may have limited capacity
14. 19We are subject to a multitude of manufacturing risks, any of which could substantially increase our costs and limit supply of our product candidates
15. 20the manufacturing facilities in which our product candidates are made could be adversely affected by equipment failures, labor shortages, natural disasters, power failures, and numerous other factors

Risks Related to Commercialization of Our Product Candidates

1. 21We face intense competition and rapid technological change and the possibility that our competitors may develop therapies that are similar, more advanced, or more effective than ours, which may adversely affect our financial condition and our ability to successfully commercialize our product candidates
2. 22We currently have no marketing and sales organization. If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, we may be unable to generate any revenue
3. 23The market may not be receptive to our product candidates based on a novel therapeutic modality, and we may not generate any future revenue from the sale or licensing of product candidates
4. 24availability of alternative effective treatments for the disease indications our product candidates are intended to treat and the relative risks, benefits and costs of those treatments
5. 25The insurance coverage and reimbursement status of newly-approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue
6. 26Healthcare legislative reform measures may have a material adverse effect on our business and results of operations
7. 27Our product candidates may be approved and/or commercialized only in part, only as neoadjuvant therapy, or as an adjuvant therapy

Risks Related to Competition

1. 28The pharmaceutical market is intensely competitive. If we are unable to compete effectively with existing drugs, new treatment methods and new technologies, we may be unable to commercialize successfully any drugs that we develop
2. 29collaborative arrangements in our target markets with leading companies and research institutions

Risks Related to Our Intellectual Property

1. 30If we are unable to obtain and maintain effective patent rights for our product candidates or any future product candidates, we may not be able to compete effectively in our markets
2. 31We may not have sufficient patent terms to effectively protect our products and business
3. 32Patent law, policy or rule changes could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of any issued patent
4. 33If we are unable to maintain effective proprietary rights for our product candidates or any future product candidates, we may not be able to compete effectively in our markets
5. 34Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts
6. 35We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses
7. 36We may be involved in lawsuits to protect or enforce our current patent applications or future patents, which could be expensive, time consuming, and unsuccessful
8. 37We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers
9. 38We may be subject to claims challenging the inventorship of our current patent application or future patents and other intellectual property
10. 39We may not be able to protect our intellectual property rights throughout the world

Risks Related to our Human Resources

1. 40The loss of the services of our key personnel would negatively affect our business
2. 41We may be unable to attract, develop and retain additional employees required for our development and future success

Risks Related to Our Operations

1. 42Our business and operations, or those of our CROs or third parties, may suffer in the event of computer system failures, cyberattacks or deficiencies in our cybersecurity, which could materially affect our results
2. 43If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of any approved products
3. 44Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of products we develop, alone or with collaboration partners
4. 45We may not be able to successfully identify and execute strategic alliances or other relationships with third parties or to successfully manage the impacts of acquisitions, dispositions or relationships on our operations
5. 46the loss or reduction of control over certain of our assets

Risks Related to our Operations in Israel

1. 47Conditions in the Middle East and in Israel may harm our operations

Risks Related to Ownership of Our Ordinary Shares

1. 48If we fail to maintain compliance with Nasdaq continued listing requirements, our shares may be delisted from the Nasdaq Global Market
2. 49The price of our ordinary shares and our warrants may be volatile, and the value of our ordinary shares and our warrants may decline
3. 50other events or factors, including those resulting from war, incidents of terrorism, global pandemics or responses to those events
4. 51A substantial number of our ordinary shares may be issued pursuant to the White Lion Purchase Agreement, as well as the conversion terms of the A&R Sponsor Promissory Note, which could cause (i) the price of the ordinary shares to decline, and (ii) substantial dilution to our existing shareholders
5. 52Because we have no current plans to pay cash dividends on our ordinary shares for the foreseeable future, you may not receive any return on investment unless you sell New Silexion ordinary shares for a price greater than that which you paid for it

General Risks

1. 53The Company may be subject to securities litigation, which is expensive and could divert management attention, including securities class action and derivative lawsuits which could result in substantial costs