What changed in Silexion Therapeutics Corp's 10-K — 2024 vs 2025
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Paragraph-level year-over-year comparison of Silexion Therapeutics Corp's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.
+186 added−940 removedSource: 10-K (2026-03-17) vs 10-K (2025-03-18)
Top changes in Silexion Therapeutics Corp's 2025 10-K
186 paragraphs added · 940 removed · 154 edited across 1 sections
- Item 1A. Risk Factors+186 / −940 · 154 edited
Item 1A. Risk Factors
Risk Factors — what could go wrong, per management
154 edited+32 added−786 removed282 unchanged
Item 1A. Risk Factors
Risk Factors — what could go wrong, per management
154 edited+32 added−786 removed282 unchanged
2024 filing
2025 filing
Biggest changeIn such an event, such studies could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny or withdraw approval of our product candidates for any or all targeted indications. 40 The drug-related, drug-product related, and administration related side effects could affect patient recruitment, the ability of enrolled patients to complete the study, or result in potential product liability claims. we do not currently have product liability insurance and does not anticipate obtaining product liability insurance until such time as we have received FDA or other comparable foreign authority approval for a product and there is a product that is being provided to patients outside of clinical trials.
Biggest changeIn such an event, such studies could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny or withdraw approval of our product candidates for any or all targeted indications.
We are the early stages of clinical and preclinical development for our product candidates, we have we have not yet commenced pivotal clinical studies for any product candidate and it may be several years, if ever, before we complete pivotal clinical studies and have a product candidate approved for commercialization.
We are the early stages of clinical and preclinical development for our product candidates, we have not yet commenced pivotal clinical studies for any product candidate, and it may be several years, if ever, before we complete pivotal clinical studies and have a product candidate approved for commercialization.
If microbial, viral, or other contaminations are discovered in our product candidates or in the manufacturing facilities in which our product candidates are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination; and ● the 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.
If microbial, viral, or other contaminations are discovered in our product candidates or in the manufacturing facilities in which our product candidates are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination; and ● the manufacturing facilities in which our product candidates are made could be adversely affected by equipment failures, labor shortages, natural disasters, power failures, or numerous other factors.
We currently rely on third parties to manufacture the raw materials and products that we use to create our product candidates and to supply us with the medical devices used to administer such product.
We currently rely on third parties to manufacture the raw materials and products that we use to create our product candidates and to supply us with the medical devices used to administer such product candidates.
We do not currently have the infrastructure or capability internally to develop the raw materials and other products that we use to manufacture our product candidates, and we lack the resources and the capability to manufacture the medical devices which we use to administer our products.
We do not currently have the infrastructure or capability internally to develop the raw materials and other products that we use to manufacture our product candidates, and we lack the resources and the capability to manufacture the medical devices which we use to administer our product candidates.
Safe and effective means to deliver RNAi based drugs and to the relevant cell and tissue types may be developed by our competitors, and our ability to successfully commercialize a competitive product would be adversely affected.
Safe and effective means to deliver RNAi based drugs to the relevant cell and tissue types may be developed by our competitors, and our ability to successfully commercialize a competitive product would be adversely affected.
For example, Novartis is working on a SHP2 inhibitor, and Boehringer Ingelheim and Bayer SOS1 inhibitors; Threshold Pharmaceuticals (Threshold) is working to develop therapies that target tumor hypoxia, a common characteristic of the tumor microenvironment.
For example, Novartis is working on a SHP2 inhibitor, and Boehringer Ingelheim and Bayer SOS1 inhibitors; and Threshold Pharmaceuticals (Threshold) is working to develop therapies that target tumor hypoxia, a common characteristic of the tumor microenvironment.
We rely upon a combination of trade secret protection and confidentiality agreements to protect the intellectual property related to our technologies and product candidates. As further described in detail below, we have pending PCT application in several international (i.e. non-U.S.) locations relating the SIL204, which upon grant will provide patent protection in the U.S., E.U. and other international jurisdictions.
We rely upon a combination of trade secret protection and confidentiality agreements to protect the intellectual property related to our technologies and product candidates. As further described in detail below, we have pending PCT application in several international (i.e., non-U.S.) locations relating to SIL204, which upon grant will provide patent protection in the U.S., E.U. and other international jurisdictions.
An emerging growth company can therefore delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected not to opt out of such extended transition period and, therefore, the Company may not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.
An emerging growth company can therefore delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected not to opt out of such extended transition period and, therefore, we may not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.
We anticipate that our expenses will increase substantially if and as we: ● continue and expand our research and preclinical and clinical development of our product candidates; ● initiate additional preclinical, toxicology, clinical, or other studies for our product candidates; ● continue to improve our quality standards and change or add additional manufacturers or suppliers; ● seek regulatory and marketing approvals for our product candidates that successfully complete clinical studies; ● establish a sales, marketing, and distribution infrastructure to commercialize any products for which we may obtain marketing approval; ● seek to identify, assess, acquire, license, and/or develop other product candidates; ● enter into license agreements; ● seek to maintain, protect, and expand our intellectual property portfolio; ● seek to attract and retain skilled personnel; ● create additional infrastructure to support our operations as a public company and our product development and planned future commercialization efforts; and ● experience any delays or encounter issues with any of the above, including but not limited to failed studies, complex results, safety issues, or other regulatory challenges that require longer follow-up of existing studies, additional major studies, or additional supportive studies in order to pursue marketing approval.
We anticipate that our expenses will increase substantially if and as we: ● continue and expand our research and preclinical and clinical development of our product candidates; ● initiate additional clinical or other studies for our product candidates; ● continue to improve our quality standards and change or add additional manufacturers or suppliers; ● seek regulatory and marketing approvals for our product candidates that successfully complete clinical studies; ● establish a sales, marketing, and distribution infrastructure to commercialize any products for which we may obtain marketing approval; ● seek to identify, assess, acquire, license, and/or develop other product candidates; ● enter into license agreements; ● seek to maintain, protect, and expand our intellectual property portfolio; ● seek to attract and retain skilled personnel; ● create additional infrastructure to support our operations as a public company and our product development and planned future commercialization efforts; and ● experience any delays or encounter issues with any of the above, including but not limited to failed studies, complex results, safety issues, or other regulatory challenges that require longer follow-up of existing studies, additional major studies, or additional supportive studies in order to pursue marketing approval.
Market acceptance of Silexion’s product candidates will depend on, among other factors: ● the timing of our receipt of any marketing and commercialization approvals; ● the terms of any approvals and the countries in which approvals are obtained; ● the safety and efficacy of our product candidates; ● the prevalence and severity of any adverse side effects associated with our product candidates; ● limitations or warnings contained in any labeling approved by the FDA or other regulatory authorities; ● relative convenience and ease of administration of our product candidates; ● the willingness of patients to accept any new methods of administration; ● the success of our physician education programs; ● the availability of adequate government and third-party payor reimbursement; ● the pricing of our products, particularly as compared to alternative treatments; and ● availability 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.
Market acceptance of our product candidates will depend on, among other factors: ● the timing of our receipt of any marketing and commercialization approvals; ● the terms of any approvals and the countries in which approvals are obtained; ● the safety and efficacy of our product candidates; ● the prevalence and severity of any adverse side effects associated with our product candidates; ● limitations or warnings contained in any labeling approved by the FDA or other regulatory authorities; ● relative convenience and ease of administration of our product candidates; ● the willingness of patients to accept any new methods of administration; ● the success of our physician education programs; ● the availability of adequate government and third-party payor reimbursement; ● the pricing of our products, particularly as compared to alternative treatments; and ● availability 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.
Many of our competitors have: ● much greater financial, technical and human resources than we have at every stage of the discovery, development, manufacture and commercialization of products; ● more extensive experience in pre-clinical testing, conducting clinical trials, obtaining regulatory approvals, and in manufacturing, marketing and selling pharmaceutical products; ● product candidates that are based on previously tested or accepted technologies; ● products that have been approved or are in late stages of development; and ● collaborative arrangements in our target markets with leading companies and research institutions.
Many of our competitors have: ● much greater financial, technical and human resources than we have at every stage of the discovery, development, manufacture and commercialization of products; ● more extensive experience in pre-clinical testing, conducting clinical trials, obtaining regulatory approvals, and in manufacturing, marketing and selling pharmaceutical products; 50 ● product candidates that are based on previously tested or accepted technologies; ● products that have been approved or are in late stages of development; and ● collaborative arrangements in our target markets with leading companies and research institutions.
Our ability to generate future revenue from product sales depends heavily on our success in many areas, including but not limited to: ● completing research and preclinical and toxicology and clinical development of our product candidates; ● obtaining regulatory and marketing approvals for our product candidates, if and when we complete clinical studies; ● developing a sustainable and scalable in-house manufacturing process, meeting all regulatory standards for approved product candidates, and in some instances, establishing and maintaining supply and manufacturing relationships with third parties that can conduct the process and provide adequate (in amount and quality) products to support clinical development and the market demand for product candidates, if approved; ● launching and commercializing product candidates, if and when we obtain regulatory and marketing approval, either directly or with a collaborator or distributor; ● exposing, educating and training physicians to use our products; ● obtaining market acceptance of our product candidates as viable treatment options; ● addressing any competing technological and market developments; ● identifying, assessing, acquiring and/or developing new product candidates; ● negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter; ● maintaining, protecting, and expanding our portfolio of intellectual property rights, including patents, trade secrets, and know-how; and ● attracting, hiring, and retaining qualified personnel.
Our ability to generate future revenue from product sales depends heavily on our success in many areas, including but not limited to: ● completing research and clinical development of our product candidates; ● obtaining regulatory and marketing approvals for our product candidates, if and when we complete clinical studies; ● developing a sustainable and scalable in-house manufacturing process, meeting all regulatory standards for approved product candidates, and in some instances, establishing and maintaining supply and manufacturing relationships with third parties that can conduct the process and provide adequate (in amount and quality) products to support clinical development and the market demand for product candidates, if approved; ● launching and commercializing product candidates, if and when we obtain regulatory and marketing approval, either directly or with a collaborator or distributor; ● exposing, educating and training physicians to use our products; ● obtaining market acceptance of our product candidates as viable treatment options; ● addressing any competing technological and market developments; ● identifying, assessing, acquiring and/or developing new product candidates; ● negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter; ● maintaining, protecting, and expanding our portfolio of intellectual property rights, including patents, trade secrets, and know-how; and ● attracting, hiring, and retaining qualified personnel.
The downward pressure on healthcare costs in general, particularly prescription drugs and surgical procedures and other treatments, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products. 48 Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.
The downward pressure on healthcare costs in general, particularly prescription drugs and surgical procedures and other treatments, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products. Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.
Lilly; Pfizer, Novartis International AG, Takeda Pharmaceutical Company Limited and, and biopharmaceutical/pharmaceutical companies such as Alnylam, Revolutions Medicines; Boehringer Ingelheim; Biomea Fusion Inc; Tekmira Pharmaceuticals Corporation, Arrowhead Research Corporation, Silence Therapeutics plc, RXi Pharmaceuticals Corporation, Quark Pharmaceuticals, Inc. and Marina Biotech, Inc. We also compete with companies working to develop antisense-based drugs.
Lilly, Pfizer, Novartis International AG, and Takeda Pharmaceutical Company Limited, and biopharmaceutical/pharmaceutical companies such as Alnylam, Revolutions Medicines, Boehringer Ingelheim, Biomea Fusion Inc., Tekmira Pharmaceuticals Corporation, Arrowhead Research Corporation, Silence Therapeutics plc, RXi Pharmaceuticals Corporation, Quark Pharmaceuticals, Inc. and Marina Biotech, Inc. 51 We also compete with companies working to develop antisense-based drugs.
If the New Silexion Group includes one or more non-U.S. subsidiaries, certain of our non-U.S. subsidiaries could be treated as CFCs regardless of whether we are treated as a CFC. If we or any of our non-U.S. subsidiaries is a CFC, 10% “United States shareholders” will be subject to adverse income inclusion and reporting requirements with respect to such CFC.
If the Silexion Group includes one or more non-U.S. subsidiaries, certain of our non-U.S. subsidiaries could be treated as CFCs regardless of whether we are treated as a CFC. If we or any of our non-U.S. subsidiaries is a CFC, 10% “United States shareholders” will be subject to adverse income inclusion and reporting requirements with respect to such CFC.
If we are found to have promoted such unapproved, or off-label, uses, they may become subject to significant liability. The U.S. federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion.
If we are found to have promoted such unapproved, or off-label, uses, we may become subject to significant liability. The U.S. federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion.
Limitation in commercialization of such treatments, including limitations in supply, call-back, clinical holds, changes in medical trends, changes in cost and/or reimbursement policy, may limit our ability to commercialize our product candidates, either directly or via third parties. 49 Risks Related to Competition The pharmaceutical market is intensely competitive.
Limitation in commercialization of such treatments, including limitations in supply, call-back, clinical holds, changes in medical trends, changes in cost and/or reimbursement policy, may limit our ability to commercialize our product candidates, either directly or via third parties. Risks Related to Competition The pharmaceutical market is intensely competitive.
We have no products approved for commercialization and has never generated any revenue. Our ability to generate revenue and achieve profitability depends on our ability, alone or with strategic collaboration partners, to successfully complete the development of, and obtain the regulatory and marketing approvals necessary to commercialize, one or more of our product candidates.
We have no products approved for commercialization and have never generated any revenue. Our ability to generate revenue and achieve profitability depends on our ability, alone or with strategic collaboration partners, to successfully complete the development of, and obtain the regulatory and marketing approvals necessary to commercialize, one or more of our product candidates.
CROs may also generate higher costs than anticipated. As a result, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase, and our ability to generate revenue could be delayed. Switching or adding additional CROs involves additional cost and requires management time and focus.
CROs may also generate higher costs than anticipated. As a result, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase, and our ability to generate revenue could be delayed. Switching or adding additional CROs involves additional costs and requires management time and focus.
Our per-patient prices must be sufficient to recover our development and manufacturing costs and potentially achieve profitability. Accordingly, the availability and adequacy of coverage and reimbursement by governmental and private payors are essential for most patients to be able to afford expensive treatments such as our, assuming approval.
Our per-patient prices must be sufficient to recover our development and manufacturing costs and potentially achieve profitability. Accordingly, the availability and adequacy of coverage and reimbursement by governmental and private payors are essential for most patients to be able to afford expensive treatments such as ours, assuming approval.
Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. We may be subject to claims challenging the inventorship of our current patent application or future patents and other intellectual property.
Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. 57 We may be subject to claims challenging the inventorship of our current patent application or future patents and other intellectual property.
Given that our proprietary position is based, in part, on our know- how and trade secrets, a competitor’s discovery of our trade secrets or other unauthorized use or disclosure would impair our competitive position and may have a material adverse effect on our business. 44 Our reliance on third parties to manufacture the raw materials and products that are used to create our product candidates and to supply us with the medical devices used to administer such product might cause our business harm if manufacturers fail to provide us with sufficient quantities of these materials and products or fail to do so at acceptable quality levels or prices.
Given that our proprietary position is based, in part, on our know- how and trade secrets, a competitor’s discovery of our trade secrets or other unauthorized use or disclosure would impair our competitive position and may have a material adverse effect on our business. 45 Our reliance on third parties to manufacture the raw materials and products that are used to create our product candidates and to supply us with the medical devices used to administer such product candidates might cause our business harm if manufacturers fail to provide us with sufficient quantities of these materials and products or fail to do so at acceptable quality levels or prices.
As such, we will be eligible for and intend to take advantage of certain exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies for as long as we continue to be an emerging growth company, including (a) the exemption from the auditor attestation requirements with respect to internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act, (b) the exemptions from say-on-pay, say-on-frequency and say-on-golden parachute voting requirements and (c) reduced disclosure obligations regarding executive compensation in its periodic reports and proxy statements.
As such, we will be eligible for and intend to take advantage of certain exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies for as long as we continue to be an emerging growth company, including (a) the exemption from the auditor attestation requirements with respect to internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act, (b) the exemptions from say-on-pay, say-on-frequency and say-on-golden parachute voting requirements and (c) reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements.
Litigation of this type could result in substantial costs and diversion of management’s attention and resources, which could have a material adverse effect on our business, financial condition, and results of operations. Any adverse determination in litigation could also subject the Company to significant liabilities.
Litigation of this type could result in substantial costs and diversion of management’s attention and resources, which could have a material adverse effect on our business, financial condition, and results of operations. Any adverse determination in litigation could also subject our company to significant liabilities.
In addition, decisions by other companies with respect to their RNAi development efforts may increase skepticism in the marketplace regarding the potential for RNAi therapeutics. 36 Relatively few product candidates based on these discoveries have ever been tested in animals or humans. siRNAs may not naturally possess the inherent properties typically required of drugs, such as the ability to be stable in the body long enough to reach the tissues in which their effects are required, or the ability to enter cells within these tissues in order to exert their effects.
In addition, decisions by other companies with respect to their RNAi development efforts may increase skepticism in the marketplace regarding the potential for RNAi therapeutics. 37 Relatively few product candidates based on these discoveries have ever been tested in animals or humans. siRNAs may not naturally possess the inherent properties typically required of drugs, such as the ability to be stable in the body long enough to reach the tissues in which their effects are required, or the ability to enter cells within these tissues in order to exert their effects.
No assurance can be provided that we will assist holders in determining whether we or any of our non-U.S. subsidiaries is treated as a CFC or whether any holder is treated as a United States shareholder with respect to any of such CFCs, or furnish to any holder information that may be necessary to comply with reporting and tax payment obligations with respect to such CFCs. 68 General Risks The 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.
No assurance can be provided that we will assist holders in determining whether we or any of our non-U.S. subsidiaries is treated as a CFC or whether any holder is treated as a United States shareholder with respect to any of such CFCs, or furnish to any holder information that may be necessary to comply with reporting and tax payment obligations with respect to such CFCs. 68 General Risks We 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.
The Leahy-Smith Act and our implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business and financial condition.
The Leahy-Smith Act and our implementation of it could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business and financial condition.
The results of preclinical studies and early clinical studies of product candidates often are not predictive of the results of later-stage clinical studies. In general, even product candidates that have shown promising results in preclinical activities or early-stage clinical studies may still suffer significant setbacks in subsequent registration clinical studies.
The results of preclinical studies and early clinical studies of product candidates often are not predictive of the results of later-stage clinical studies. In general, even product candidates that have shown promising results in preclinical activities or early-stage clinical studies may still suffer significant setbacks in subsequent clinical studies.
The Bayh-Dole Act also provides federal agencies with “march-in rights.” March-in rights allow the government, in specified circumstances, to require the contractor or successors in title to the patent to grant a “nonexclusive, partially exclusive, or exclusive license” to a “responsible applicant or applicants.” If the patent owner refuses to do so, the government may grant the license itself. 53 If 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.
The Bayh-Dole Act also provides federal agencies with “march-in rights.” March-in rights allow the government, in specified circumstances, to require the contractor or successors in title to the patent to grant a “nonexclusive, partially exclusive, or exclusive license” to a “responsible applicant or applicants.” If the patent owner refuses to do so, the government may grant the license itself. 54 If 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.
Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patent or narrow the scope of our patent protection. The laws of foreign countries may not protect our rights to the same extent as the laws of the United States.
Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection. The laws of foreign countries may not protect our rights to the same extent as the laws of the United States.
Developing our product candidates is expensive, and we expect our research and development expenses to increase substantially in connection with our ongoing activities, particularly as we advance pour product candidates through clinical studies.
Developing our product candidates is expensive, and we expect our research and development expenses to increase substantially in connection with our ongoing activities, particularly as we advance our product candidates through clinical studies.
In light of our significant working capital needs and the absence of any committed source of financing to meet those needs, there may be substantial doubt raised about our ability to continue as a “going concern.” Please see the explanatory paragraph under the heading “Substantial Doubt about the Company’s Ability to Continue as a Going Concern” in our independent auditors’ report on our financial statements that appear in this Annual Report.
In light of our significant working capital needs and the absence of any committed source of financing to meet those needs, there may be substantial doubt raised about our ability to continue as a “going concern.” Please see the explanatory paragraph under the heading “ Substantial Doubt about the Company’s Ability to Continue as a Going Concern ” in our independent auditors’ report on our financial statements that appear in this Annual Report.
Factors that could cause fluctuations in the trading price of our ordinary shares and our warrants include the following: ● actual or anticipated fluctuations in our financial condition or results of operations; ● variance in the projected timeline for regulatory approvals of our product candidates from expectations of securities analysts; ● changes in laws or regulations applicable to our business; ● announcements by us or our competitors of significant business developments; ● significant data breaches, disruptions to or other incidents involving our company; ● conditions or developments affecting the biotechnology industry; ● future sales of New Silexion ordinary shares by us or our shareholders, as well as the anticipation of lock-up releases; ● changes in senior management or key personnel; ● the trading volume of our securities; ● changes in the anticipated future size and growth rate of our markets; ● publication of research reports or news stories about us, our competitors or our industry, or positive or negative recommendations or withdrawal of research coverage by securities analysts; ● general economic and market conditions; and ● other events or factors, including those resulting from war, incidents of terrorism, global pandemics or responses to those events.
Factors that could cause fluctuations in the trading price of our ordinary shares and our warrants include the following: ● actual or anticipated fluctuations in our financial condition or results of operations; ● variance in the projected timeline for regulatory approvals of our product candidates from expectations of securities analysts; ● changes in laws or regulations applicable to our business; 64 ● announcements by us or our competitors of significant business developments; ● significant data breaches, disruptions to or other incidents involving our company; ● conditions or developments affecting the biotechnology industry; ● future sales of ordinary shares by us or our shareholders, as well as the anticipation of lock-up releases; ● changes in senior management or key personnel; ● the trading volume of our securities; ● changes in the anticipated future size and growth rate of our markets; ● publication of research reports or news stories about us, our competitors or our industry, or positive or negative recommendations or withdrawal of research coverage by securities analysts; ● general economic political, or market conditions; and ● other events or factors, including those resulting from war, incidents of terrorism, global pandemics or responses to those events.
If our product candidates are approved but fail to achieve an adequate level of acceptance by physicians, patients, third-party payors, and others in the medical community, we will not be able to generate sufficient revenue for us to become or remain profitable. 47 The insurance coverage and reimbursement status of newly-approved products is uncertain.
If our product candidates are approved but fail to achieve an adequate level of acceptance by physicians, patients, third-party payors, and others in the medical community, we will not be able to generate sufficient revenue for us to become or remain profitable. 48 The insurance coverage and reimbursement status of newly-approved products is uncertain.
Us, our collaborators, or any contract manufacturers must supply all necessary documentation in support of an NDA, BLA, or Marketing Authorization Application (MAA) on a timely basis and must adhere to Good Laboratory Practices (GLP) and cGMP/GMP regulations enforced by the FDA and other regulatory agencies through their facilities and data and documentation inspection programs.
We, our collaborators, or any contract manufacturers must supply all necessary documentation in support of an NDA, BLA, or Marketing Authorization Application (MAA) on a timely basis and must adhere to Good Laboratory Practices (GLP) and cGMP/GMP regulations enforced by the FDA and other regulatory agencies through their facilities and data and documentation inspection programs.
For example, there is an increasing number of companies commercializing treatments and/or developing programs specifically targeting KRAS mutations, including KRAS G12D and KRAS G12V, in a variety of manners and for a variety of indications, including cancer, including Bristol-Myers Squibb Company (through the recently acquired Mirati Therapeutics, Inc.), Revolution Medicines, Inc., AstraZeneca (in collaboration with Usynova), Boehringer and Gilead.
For example, there are an increasing number of companies commercializing treatments and/or developing programs specifically targeting KRAS mutations, including KRAS G12D and KRAS G12V, in a variety of manners and for a variety of indications, including cancer, including Bristol-Myers Squibb Company (through the recently acquired Mirati Therapeutics, Inc.), Revolution Medicines, Inc., AstraZeneca (in collaboration with Usynova), Boehringer and Gilead.
Without an internal team or the support of a third party to perform marketing and sales functions, we may be unable to compete successfully against these more established companies. 46 The 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.
Without an internal team or the support of a third party to perform marketing and sales functions, we may be unable to compete successfully against these more established companies. 47 The 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.
We will also be required to report certain adverse reactions and production problems, if any, to the FDA, and to comply with requirements concerning advertising and promotion for our products. Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved label.
We will also be required to report certain adverse reactions and production problems, if any, to the FDA, and to comply with requirements concerning advertising and promotion for our product. Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved label.
If we do not have sufficient patent terms or regulatory exclusivity to protect our products, our business and results of operations will be adversely affected. Furthermore, manufacturers of innovative products as well as generic drug manufacturers may be able to design their products around our patents and compete with Silexion using the resulting alternative technology.
If we do not have sufficient patent terms or regulatory exclusivity to protect our products, our business and results of operations will be adversely affected. Furthermore, manufacturers of innovative products as well as generic drug manufacturers may be able to design their products around our patents and compete with us using the resulting alternative technology.
Patents covering our key products may be subject to validity, enforceability and infringement challenges in patent litigations and post-grant review patent office proceedings. It may be possible for these parties to successfully challenge our rights and launch their versions of our drugs prior to the expiration of our intellectual property rights. 52 In addition, both the U.S.
Patents covering our key products may be subject to validity, enforceability and infringement challenges in patent litigations and post-grant review patent office proceedings. It may be possible for these parties to successfully challenge our rights and launch their versions of our drugs prior to the expiration of our intellectual property rights. In addition, both the U.S. Congress and the U.S.
Further, if we are not able to generate revenue from the sale of any approved products, we may be forced to cease operations. 34 We will need to raise substantial additional funding before we can expect to become profitable from product sales. This additional financing may not be available on acceptable terms, or at all.
Further, if we are not able to generate revenue from the sale of any approved products, we may be forced to cease operations. 35 We will need to raise substantial additional funding before we can expect to become profitable from product sales. This additional financing may not be available on acceptable terms, or at all.
You should carefully consider the risks and uncertainties described below, together with all of the other information contained in this Annual Report, including our financial statements and related notes appearing in Item 8, and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Item 7, before deciding to invest in our securities.
You should carefully consider the risks and uncertainties described below, together with all of the other information contained in this Annual Report, including our financial statements and related notes appearing in Part II, Item 8, and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part II, Item 7, before deciding to invest in our securities.
If such an infringement claim should be brought and be successful, we may be required to pay substantial damages, be forced to abandon our product candidates or seek a license from any patent holders. No assurances can be given that a license will be available on commercially reasonable terms, if at all.
If such an infringement claim is brought and is successful, we may be required to pay substantial damages, be forced to abandon our product candidates or seek a license from any patent holders. No assurances can be given that a license will be available on commercially reasonable terms, if at all.
Clinical study delays could also shorten any periods during which our products have patent protection and may allow our competitors to bring products to market before we do, which could impair our ability to obtain orphan exclusivity and to successfully commercialize our product candidates. 39 We may find it difficult to enroll patients in our clinical studies.
Clinical study delays could also shorten any periods during which our products have patent protection and may allow our competitors to bring products to market before we do, which could impair our ability to obtain orphan exclusivity and to successfully commercialize our product candidates. 40 We may find it difficult to enroll patients in our clinical studies.
If these facilities do not pass a preapproval plant inspection, regulatory approval of the products may not be granted or may be substantially delayed until any violations are corrected to the satisfaction of the regulatory authority, if ever. 42 The regulatory authorities also may, at any time following approval of a product for sale, audit a manufacturing facility.
If these facilities do not pass a preapproval plant inspection, regulatory approval of the products may not be granted or may be substantially delayed until any violations are corrected to the satisfaction of the regulatory authority, if ever. 43 The regulatory authorities also may, at any time following approval of a product for sale, audit a manufacturing facility.
If we fail in any such dispute, in addition to being forced to pay damages, we may be temporarily or permanently prohibited from commercializing our product candidates that are held to be infringing. We might, if possible, also be forced to redesign our product candidates so that we no longer infringes the third party intellectual property rights.
If we fail in any such dispute, in addition to being forced to pay damages, we may be temporarily or permanently prohibited from commercializing our product candidates that are held to be infringing. We might, if possible, also be forced to redesign our product candidates so that we no longer infringe the third party intellectual property rights.
Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business. 54 Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business. 55 Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
These established companies may have a competitive advantage over us due to their size, cash resources, and greater clinical development and commercialization capabilities. 55 For example, we sometimes collaborate with U.S. and foreign academic institutions to accelerate our preclinical research or development under written agreements with these institutions.
These established companies may have a competitive advantage over us due to their size, cash resources, and greater clinical development and commercialization capabilities. 56 For example, we sometimes collaborate with U.S. and foreign academic institutions to accelerate our preclinical research or development under written agreements with these institutions.
Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm our business, results of operations, and prospects. Even if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory scrutiny.
Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm our business, results of operations, and prospects. Even if we obtain regulatory approval for a product candidate, the related product will remain subject to regulatory scrutiny.
Foreign regulatory authorities impose similar requirements. 41 If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or disagrees with the promotion, marketing or labeling of a product, such regulatory agency may impose restrictions on that product or us, including requiring withdrawal of the product from the market.
Foreign regulatory authorities impose similar requirements. 42 If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or disagrees with the promotion, marketing or labeling of a product, such regulatory agency may impose restrictions on that product or us, including requiring withdrawal of the product from the market.
Our future success depends to a large extent on the continued services of our senior management and key personnel, including in particular, Ilan Hadar, Dr. Mitchell Shirvan, Dr. Racheli Malka and Michal Yaron. Any loss of the services of members of our senior management or key employees would adversely affect our business.
Our future success depends to a large extent on the continued services of our senior management and key personnel, including in particular, Ilan Hadar, Dr. Mitchell Shirvan, Dr. Racheli Malka, Dr. Gadi Sarfati and Michal Yaron. Any loss of the services of members of our senior management or key employees would adversely affect our business.
We could also be asked to conduct post-marketing clinical studies to verify the safety and efficacy of our products in general or in specific patient subsets. If we obtain original marketing approval via the accelerated approval pathway, we could be required to conduct a successful post-marketing clinical study to confirm clinical benefit for our products.
We could also be asked to conduct post-marketing clinical studies to verify the safety and efficacy of our product in general or in specific patient subsets. If we obtain original marketing approval via the accelerated approval pathway, we could be required to conduct a successful post-marketing clinical study to confirm clinical benefit for our product.
Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license. 57 Risks Related to our Human Resources The loss of the services of our key personnel would negatively affect our business.
Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license. 58 Risks Related to Our Human Resources The loss of the services of our key personnel would negatively affect our business.
The interruption or curtailment of trade between Israel and its trading partners could adversely affect our operations and results of operations. 61 Our commercial insurance does not cover losses that may occur as a result of events associated with the security situation in the Middle East.
The interruption or curtailment of trade between Israel and its trading partners could adversely affect our operations and results of operations. 62 Our commercial insurance does not cover losses that may occur as a result of events associated with the security situation in the Middle East.
Further, the net losses we incur may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison of our results of operations may not be a good indication of our future performance. 33 We have never generated any revenue from product sales and may never be profitable.
Further, the net losses we incur may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison of our results of operations may not be a good indication of our future performance. 34 We have never generated any revenue from product sales and may never be profitable.
We have used substantial funds to develop our product candidates and delivery technologies and will require significant funds to conduct further research and development and preclinical testing and clinical trials of our product candidates, to seek regulatory approvals for our product candidates and to manufacture and market products, if any, which are approved for commercial sale.
We have used substantial funds to develop our product candidates and delivery technologies and will require significant funds to conduct further research and development and clinical trials of our product candidates, to seek regulatory approvals for our product candidates and to manufacture and market products, if any, which are approved for commercial sale.
We will remain an emerging growth company until the earliest of (i) the last day of the fiscal year in which the market value of our ordinary shares that are held by non-affiliates is equal to or exceeds $700 million as of the end of that year’s second fiscal quarter, (ii) the last day of the fiscal year in which we have total annual gross revenue of $1.235 billion or more during such fiscal year (as indexed for inflation), (iii) the date on which we have issued more than $1 billion in non-convertible debt in the prior three-year period or (iv) the last day of the fiscal year following the fifth anniversary of the date of the first issuance of our ordinary shares in the Business Combination.
We will remain an emerging growth company until the earliest of (i) the last day of the fiscal year in which the market value of our ordinary shares that are held by non-affiliates is equal to or exceeds $700 million as of the end of that year’s second fiscal quarter, (ii) the last day of the fiscal year in which we have total annual gross revenue of $1.235 billion or more during such fiscal year (as indexed for inflation), (iii) the date on which we have issued more than $1 billion in non-convertible debt in the prior three-year period or (iv) the last day of the fiscal year following the fifth anniversary of the date of the first issuance of our ordinary shares in the Business Combination (i.e., on December 31, 2029).
Our future funding requirements will depend on many factors, including but not limited to: ● the scope, rate of progress, results and cost of our clinical studies, preclinical testing, toxicology studies, and other related activities; ● the cost of manufacturing clinical supplies, and establishing commercial supplies of our product candidates and any future products; ● the number and characteristics of product candidates that we pursue; ● the cost, timing, and outcomes of regulatory approvals; ● the cost and timing of establishing sales, marketing, and distribution capabilities; and ● the terms and timing of any collaborative, licensing, and other arrangements that we may establish.
Our future funding requirements will depend on many factors, including but not limited to: ● the scope, rate of progress, results and cost of our clinical studies and other related activities; ● the cost of manufacturing clinical supplies, and establishing commercial supplies of our product candidates and any future products; ● the number and characteristics of product candidates that we pursue; ● the cost, timing, and outcomes of regulatory approvals; ● the cost and timing of establishing sales, marketing, and distribution capabilities; and ● the terms and timing of any collaborative, licensing, and other arrangements that we may establish.
Even if we are successful in obtaining approval in one jurisdiction, it cannot ensure that we will obtain approval in any other jurisdictions.
Even if we are successful in obtaining approval in one jurisdiction, we cannot ensure that we will obtain approval in any other jurisdictions.
If we are unable to obtain approval for our product candidates in multiple jurisdictions, our revenue and results of operations could be negatively affected. 37 The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming, and inherently unpredictable.
If we are unable to obtain approval for our product candidates in multiple jurisdictions, our revenue and results of operations could be negatively affected. 38 The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming, and inherently unpredictable.
Our share price may be volatile and, in the past, companies that have experienced volatility in the market price of their stock or shares have been subject to securities litigation, including class action litigation. The Company may be the target of this type of litigation in the future.
Our share price may be volatile and, in the past, companies that have experienced volatility in the market price of their stock or shares have been subject to securities litigation, including class action litigation. We may be the target of this type of litigation in the future.
Silexion will require significant funds to conduct further research and development and preclinical testing and clinical trials of our product candidates, to seek regulatory approvals for our product candidates and to manufacture and market products, if any, which are approved for commercial sale.
We will require significant funds to conduct further research and development and preclinical testing and clinical trials of our product candidates, to seek regulatory approvals for our product candidates and to manufacture and market products, if any, which are approved for commercial sale.
If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of the Company and our operating results will be adversely affected. The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of our company and the results of our operations will be adversely affected. The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
Holder is treated as owning (directly, indirectly or constructively) at least 10% of the value or voting power of our shares, such holder may be treated as a “United States shareholder” with respect to each of New Silexion and our direct and indirect subsidiaries (the “ New Silexion Group ”) that is a “controlled foreign corporation,” (a “CFC”), for U.S. federal income tax purposes.
Holder is treated as owning (directly, indirectly or constructively) at least 10% of the value or voting power of our shares, such holder may be treated as a “United States shareholder” with respect to each of Silexion and our direct and indirect subsidiaries (the “ Silexion Group ”) that is a “controlled foreign corporation,” (a “ CFC ”), for U.S. federal income tax purposes.
If we fail to comply with applicable regulatory requirements, a regulatory agency or enforcement authority may, among other things: ● issue warning letters; ● impose civil or criminal penalties; ● suspend or withdraw regulatory approval; ● suspend any of our ongoing clinical studies; ● refuse to approve pending applications or supplements to approved applications submitted by Silexion; or ● seize or detain products, or require a product recall.
If we fail to comply with applicable regulatory requirements, a regulatory agency or enforcement authority may, among other things: ● issue warning letters; ● impose civil or criminal penalties; ● suspend or withdraw regulatory approval; ● suspend any of our ongoing clinical studies; ● refuse to approve pending applications or supplements to approved applications submitted by us; or ● seize or detain a product, or require a product recall.
The White House, SEC and other regulators have also increased their focus on companies’ cybersecurity vulnerabilities and risks. 58 Our CROs and certain of our service providers are from time to time, subject to cyberattacks and security incidents.
The White House, SEC and other regulators have also increased their focus on companies’ cybersecurity vulnerabilities and risks. 59 Our CROs and certain of our service providers are from time to time subject to cyberattacks and security incidents.
Please see the risk factor below titled “Our independent registered public accounting firm’s report contains an explanatory paragraph...” Beyond our activities for the next 12 months, we furthermore expect that we will require substantial additional capital to advance manufacturing capabilities for, to obtain regulatory approval for, and to commercialize, our product candidates.
Please see the risk factor below titled “ Our independent registered public accounting firm’s report contains an explanatory paragraph ...” Beyond requiring funding for our activities for the next 12 months, we furthermore expect that we will require substantial additional capital to advance manufacturing capabilities for, to obtain regulatory approval for, and to commercialize, our product candidates.
We may also have to take inventory write-offs and incur other charges and expenses for product candidates that fail to meet specifications, undertake costly remediation efforts, or seek more costly manufacturing alternatives. 43 Risks Related to Our Reliance on Third Parties We rely on third parties to conduct its preclinical and clinical studies and perform other tasks for us.
We may also have to take inventory write-offs and incur other charges and expenses for product candidates that fail to meet specifications, undertake costly remediation efforts, or seek more costly manufacturing alternatives. 44 Risks Related to Our Reliance on Third Parties We rely on third parties to conduct our preclinical and clinical studies and perform other tasks for us.
Any regulatory approvals that we receive for our product candidates may also be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the product candidate.
Any regulatory approvals that we receive for a product candidate may also be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the product candidate.
Risks Related to the Research and Development of Silexion’s Product Candidates The approach we are taking to discover and develop novel RNAi therapeutics is unproven for oncology and may never lead to marketable products.
Risks Related to the Research and Development of Our Product Candidates The approach we are taking to discover and develop novel RNAi therapeutics is unproven for oncology and may never lead to marketable products.
In addition, our operating plans may change as a result of many factors that may currently be unknown to it, and we may need to seek additional funds sooner than planned.
In addition, our operating plans may change as a result of many factors that may currently be unknown to us, and we may need to seek additional funds sooner than planned.
Insurance coverage is increasingly expensive. We may not be able to maintain insurance at a reasonable cost or in an amount adequate to satisfy any liability that may arise, if at all. Our insurance policy contains various exclusions, and we may be subject to a product liability claim for which we have no coverage.
We may not be able to maintain insurance at a reasonable cost or in an amount adequate to satisfy any liability that may arise, if at all. Our insurance policy contains various exclusions, and we may be subject to a product liability claim for which we have no coverage.
Further, due to the current political uncertainty involving Hamas in Gaza, Hezbollah in Lebanon, Russia and Ukraine, there is an increased likelihood that the tensions could result in cyberattacks or cybersecurity incidents that could either directly or indirectly impact our or our critical third parties’ operations.
Further, due to the current tensions involving Hamas in Gaza, Hezbollah in Lebanon, and the Russia-Ukraine conflict, there is an increased likelihood that the tensions could result in cyberattacks or cybersecurity incidents that could either directly or indirectly impact our or our critical third parties’ operations.
Investors may find our ordinary shares less attractive because we rely on these exemptions, which may result in a less active trading market for our ordinary shares and its price may be more volatile. Additionally, we qualify as a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K promulgated by the SEC.
Investors may find our ordinary shares less attractive because we rely on these exemptions, which may result in a less active trading market and a trading price that is more volatile for our ordinary shares. Additionally, we qualify as a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K promulgated by the SEC.
If any of our product candidates are approved and they are found to have been improperly promoted for unapproved uses of those products, we may become subject to significant liability. The FDA and other regulatory agencies or other governmental bodies strictly regulate the promotional claims that may be made about prescription products, such as our product candidates, if approved.
If any of our product candidates is approved and is found to have been improperly promoted for unapproved uses, we may become subject to significant liability. The FDA and other regulatory agencies or other governmental bodies strictly regulate the promotional claims that may be made about prescription products, such as our product candidates, if approved.
In addition, our CROs are not our employees, and, except for remedies available to us under our agreements with such CROs, we cannot control whether or not they devote sufficient time and resources to our on-going clinical, nonclinical, and preclinical programs.
In addition, our CROs are not our employees, and, except for remedies available to us under our agreements with such CROs, we cannot control whether or not they devote sufficient time and resources to our ongoing clinical, nonclinical, and preclinical programs.
We may not have sufficient patent terms to effectively protect our products and business. In the pharmaceutical and biotechnology industries, the majority of an innovative product’s commercial value is realized during our market exclusivity period.
We may not have sufficient patent terms to effectively protect our products and business. In the pharmaceutical and biotechnology industries, most of an innovative product’s commercial value is realized during a market exclusivity period.
For example, various companies are working on nanoparticle technologies, although these products would not give the extended-release delivery of SIL204. In addition other companies such as SurModics, Inc. is a provider of drug delivery and surface modification technologies to the healthcare industry, including local delivery of drugs from drug eluting stents.
For example, various companies are working on nanoparticle technologies, although these products would not give the extended-release delivery of SIL204. In addition, other companies such as SurModics, Inc. are providers of drug delivery and surface modification technologies to the healthcare industry, including local delivery of drugs from drug eluting stents.
Additionally, the sale of a substantial number of ordinary shares to White Lion, or the anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.
Additionally, the sale of a substantial number of ordinary shares under the ATM, or the anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.
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