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Item 1A. Risk Factors

2026-03-17 compared with 2025-03-18 · 158 added, 168 removed, 711 unchanged (31% of the section changed)

Investing in our securities involves a high degree of risk.

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 any of the events or developments identified as risks below were to come to fruition, our business, prospects, operating results and financial condition could suffer materially, the trading price of our ordinary shares could decline, and you could lose all or part of your investment.

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Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk.

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.

Even if we obtain regulatory approval to market a product candidate, our future revenue will depend upon the size of any markets in which our product candidates may receive approval, and our ability to achieve sufficient market acceptance, pricing, reimbursement from third-party payors, and adequate market share for our product candidates in those markets.

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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;

initiate additional clinical or other studies for our product candidates;

continue to improve our quality standards and change or add additional manufacturers or suppliers;

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We have never generated any revenue from product sales and may never be profitable.

We have no products approved for commercialization and has never generated any revenue.

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.

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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;

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;

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We are currently advancing our SIL204 platform product through preclinical and clinical development.

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.

If our product candidates enter and advance through preclinical studies and clinical trials, we will need substantial additional funds to expand our development, regulatory, manufacturing, marketing and sales capabilities or contract with other organizations to provide those capabilities for it.

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.

If our product candidates enter and advance through clinical trials, we will need substantial additional funds to expand our development, regulatory, manufacturing, marketing and sales capabilities or contract with other organizations to provide those capabilities for us.

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.

As of December 31, 2025, our cash and cash equivalents were $6.0 million.

Based upon our then-expected level of operating expenditures, we have substantial doubt about our ability to continue as a going concern as of such date.

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.

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.

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.

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.

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 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;

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We have limited cash resources and will need to obtain additional funds in order to satisfy our liquidity needs.

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.

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.

Those financial statements do not include any adjustments that might result from our inability to continue as a “going concern.”

The 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.

Our historical financial results included in this Annual Report do not reflect the financial condition, results of operations or cash flows we would have achieved as a public company during the periods presented or those that we will achieve in the future.

The historical financial results included in this Annual Report may not be indicative of what our future financial position or results of operations may be.

Our historical financial results included in this Annual Report do not necessarily reflect the financial condition, results of operations or cash flows that we will achieve in the future.

Our financial condition and future results of operations could be materially different from amounts reflected in certain of our historical financial statements included elsewhere in this Annual Report, and it may be difficult for investors to compare our future results to historical results or to evaluate our relative performance or trends in our business.

Similarly, the unaudited pro forma financial information included in our recent prospectuses filed under the Securities Act, including in our final prospectus dated January 15, 2025 filed pursuant to Rule 424(b)(4) under the Securities Act on January 17, 2025, was presented for illustrative purposes only and was prepared based on a number of assumptions.

Accordingly, such pro forma financial information is not necessarily indicative of what our actual financial position or results of operations would have been had the Business Combination been completed on the dates indicated, and our actual financial condition and results of operations may vary materially from such pro forma financial information, including as a result of such assumptions not being accurate.

See “Unaudited Pro Forma Condensed Combined Financial Information” in our final prospectus dated January 15, 2025, filed pursuant to Rule 424(b)(4) under the Securities Act on January 17, 2025.

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

For example, some of our operating expenses may vary from the historical information included in this Annual Report due to larger expenses as we initiate or continue clinical studies.

As a further example, we may not incur some of the same non-cash financial expenses related to equity grants that we incurred in the year ended December 31, 2024 in other annual periods, as those largely related to the Closing of the Business Combination, which was a one-time event in the history of our company.

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.

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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.

We are currently has only limited data, and no conclusive evidence, to suggest that it can introduce these drug-like properties into siRNAs.

We currently have only limited data, and no conclusive evidence, to suggest that we can introduce these drug-like properties into siRNAs.

We may spend large amounts of money trying to introduce these properties, and may never succeed in doing so.

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The FDA has relatively limited experience with RNAi and siRNA based therapeutics.

Limited granted approvals to any person or entity, including us, to market and commercialize therapeutics using RNAi based drugs including siRNA, which may increase the complexity, uncertainty and length of the regulatory approval process for our product candidates.

There have been a limited number of approvals granted to any person or entity, including us, to market and commercialize therapeutics using RNAi-based drugs, including siRNA, which may increase the complexity, uncertainty and length of the regulatory approval process for our product candidates.

Further, siRNA therapies are part of a broader therapeutic category called oligonueciotides, and there are only a few approved drugs based on this therapeutic category.

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Each of our product candidates is in the early stages of development and will require additional clinical development (and in some cases additional preclinical development), management of nonclinical, clinical and manufacturing activities, regulatory approval, obtaining adequate manufacturing supply, building of a commercial organization, and significant marketing efforts before we generate any revenue from product sales.

We have concluded Phase II study on first-generation Loder and moved on to SIL204.

Silexion hopes to initiate the next clinical trial with SIL204 during the first half of 2026 for locally advanced pancreatic cancer.

We have concluded a Phase 2 study on first-generation Loder and moved on to SIL204.

We expect to initiate the next clinical trial with SIL204 during the second quarter of 2026 for locally advanced pancreatic cancer.

We are not permitted to market or promote any of our product candidates before we receive regulatory approval from the FDA or comparable foreign regulatory authorities, and we may never receive such regulatory approval for any of our product candidates.

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To obtain regulatory approval in other countries, we must comply with numerous and varying regulatory requirements of such other countries regarding safety, efficacy, chemistry, manufacturing and controls, clinical studies, commercial sales, pricing, and distribution of our product candidates.

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.

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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.

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.

For example, the safety or efficacy results generated to date in preclinical and clinical studies for siG12DLoder or preclinical studies with SIL204 do not ensure that later clinical studies will demonstrate similar results.

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Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses.

We do not know whether any Phase 1, Phase 2, Phase 3 or other clinical studies we may conduct will demonstrate consistent or adequate efficacy and safety sufficient to obtain regulatory approval to market our drug candidates.

Events that may prevent successful or timely completion of clinical development include but are not limited to:

inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation of human clinical studies;

delays in reaching a consensus with regulatory agencies on study design;

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failure to perform in accordance with the FDA’s good clinical practices requirements or applicable regulatory guidelines in other countries;

occurrence of serious adverse events associated with the product candidate that are viewed to outweigh our potential benefits;

occurrence of serious adverse events associated with the product candidate that are viewed to outweigh its potential benefits;

the cost of clinical studies of our drug candidates being greater than we anticipate;

clinical studies of our drug candidates producing negative or inconclusive results, which may result in us deciding, or regulators requiring us, to conduct additional clinical studies or abandon drug development programs;

clinical studies of our drug candidates producing negative or inconclusive results, which may result in our deciding, or regulators requiring us, to conduct additional clinical studies or abandon drug development programs;

failures associated with data interpretation, data management and data storage of such studies.

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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.

We do not currently have product liability insurance and do 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.

Additionally, if one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including but not limited to:

regulatory authorities may withdraw approvals of such product;

regulatory authorities may require additional warnings on the label;

regulatory authorities may withdraw approvals of such products;

regulatory authorities may require additional warnings on the labels;

we may be required to create a Risk Evaluation and Mitigation Strategy (REMS) plan or similar plan in other jurisdictions, which could include a medication guide outlining the risks of such side effects for distribution to patients, a communication plan for healthcare providers, and/or other elements to assure safe use;

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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.

If our product candidates are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies, and submission of safety, efficacy, and other post-market information, including both federal and state requirements in the United States and other jurisdictions, where the product might be marketed.

Even if we obtain regulatory approval for a product candidate, the related product will remain subject to regulatory scrutiny.

If a product candidate of ours is approved, it will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies, and submission of safety, efficacy, and other post-market information, including both federal and state requirements in the United States and other jurisdictions, where the product might be marketed.

Accordingly, we and others with whom we work must continue to expend time, money, and effort in all areas of regulatory compliance, including manufacturing, production, and quality control.

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.

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.

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.

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.

As such, we may not promote our products for indications or uses for which they do not have FDA approval.

As such, we may not promote our product for indications or uses for which it does not have FDA approval.

The holder of an approved NDA or BLA must also submit new or supplemental applications and obtain FDA approval for certain changes to the approved product, product labeling, or manufacturing process.

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.

An unsuccessful post-marketing study or failure to complete such a study could result in the withdrawal of marketing approval.

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suspend any of our ongoing clinical studies;

refuse to approve pending applications or supplements to approved applications submitted by Silexion;

seize or detain products, or require a product recall.

refuse to approve pending applications or supplements to approved applications submitted by us;

seize or detain a product, or require a product recall.

Any government investigation of alleged violations of law could require us to expend significant time and resources in response, and could generate negative publicity.

Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability to commercialize and generate revenue from our products.

If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of the Company and our operating results will be adversely affected.

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.

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.

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.

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If we receive marketing approval for a product candidate, physicians may nevertheless prescribe it to their patients in a manner that is inconsistent with the approved label.

If we are found to have promoted such unapproved, or off-label, uses, they may become subject to significant liability.

If we are found to have promoted such unapproved, or off-label, uses, we may become subject to significant liability.

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.

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Poor control of production processes can lead to the introduction of contaminants or to inadvertent changes in the properties or stability of our product candidates that may not be detectable in final product testing.

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.

We have never produced a commercially approved pharmaceutical product and therefore have not obtained the requisite regulatory authority approvals to do so.

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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;

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.

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.

Any adverse developments affecting manufacturing operations for our product candidates may result in shipment delays, inventory shortages, lot failures, withdrawals or recalls, or other interruptions in the supply of our product candidates.

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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.

If these third parties do not successfully carry out their contractual duties, meet expected deadlines, or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize its product candidates, and our business could be substantially harmed

We have relied upon and plans to continue to rely upon third-party CROs to monitor and manage data for our ongoing preclinical and clinical programs.

We rely on third parties to conduct our preclinical and clinical studies and perform other tasks for us.

If these third parties do not successfully carry out their contractual duties, meet expected deadlines, or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates, and our business could be substantially harmed.

We have relied upon and plan to continue to rely upon third-party CROs to monitor and manage data for our ongoing preclinical and clinical programs.

We rely on these parties for execution of our preclinical and clinical studies, and control only certain aspects of their activities.

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If any of our relationships with these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs or do so on commercially reasonable terms.

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.

If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements, or for other reasons, our clinical studies may be extended, delayed, or terminated, and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates.

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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.

Switching or adding additional CROs involves additional costs and requires management time and focus.

In addition, there is a natural transition period when a new CRO commences work.

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Though we carefully manage our relationships with our CROs, there can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition, and prospects.

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.

This reliance requires us to share our trade secrets with these third parties, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.

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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.

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.

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.

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.

There are a limited number of suppliers for these raw materials, products and devices, and there may be a need to identify alternate suppliers to prevent a possible disruption to our clinical studies, and, if approved, ultimately for commercial sale.

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The effort to identify patients with diseases we seek to treat is in its early stages, and we cannot accurately predict the number of patients for whom treatment might be possible.

Additionally, the potentially addressable patient population for each of our product candidates may be limited or may not be amenable to treatment with its product candidates, and new patients may become increasingly difficult to identify or gain access to, which would adversely affect our results of operations and business.

Additionally, the potentially addressable patient population for each of our product candidates may be limited or may not be amenable to treatment with our product candidates, and new patients may become increasingly difficult to identify or gain access to, which would adversely affect our results of operations and business.

We do not have experience producing our product candidates at commercial levels and may not achieve the necessary regulatory approvals or produce product candidates at the quality, quantities, locations, and timing needed to support commercialization.

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We are currently aware of various existing therapies in the market and in development that may in the future compete with our product candidates.

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.

Smaller and other early-stage companies may also prove to be significant competitors.

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Our competitors may succeed in developing, acquiring, or licensing on an exclusive basis, products that are more effective or less costly than any product candidate that we may develop, or achieve earlier patent protection, regulatory approval, product commercialization, and market penetration than we do.

Additionally, technologies developed by our competitors may render our potential product candidates uneconomical or obsolete, and we may not be successful in marketing our product candidates against competitors.

We currently have no marketing and sales organization.

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Further, given our lack of prior experience in marketing and selling biopharmaceutical products, our initial estimate of the size of the required sales force may be materially more or less than the size of the sales force actually required to effectively commercialize our product candidates.

As such, we may be required to hire the commercialization of our product candidates, or we may incur excess costs as a result of hiring more sales representatives than necessary.

As such, we may be required to fire some of the personnel that we hire for the commercialization of our product candidates, or we may incur excess costs as a result of hiring more sales representatives than necessary.

With respect to certain geographical markets, we may enter into collaborations with other entities to utilize their local marketing and distribution capabilities, but we may be unable to enter into such agreements on favorable terms, if at all.

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Market participants with significant influence over acceptance of new treatments, such as physicians and third-party payors, may not adopt a treatment based on RNAi, including siRNA technology, and we may not be able to convince the medical community and third-party payors to accept and use, or to provide favorable reimbursement for, our product candidates.

Market acceptance of Silexion’s product candidates will depend on, among other factors:

Market acceptance of our product candidates will depend on, among other factors:

the timing of our receipt of any marketing and commercialization approvals;

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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.

Sales of our product candidates will depend substantially, both domestically and abroad, on the extent to which the costs of our product candidates will be paid for by health maintenance, managed care, pharmacy benefit, and similar healthcare management organizations, or reimbursed by government authorities, private health insurers, and other third-party payors.

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Such competitors could also recruit our employees, which could negatively impact our level of expertise and the ability to execute on our business plan.

We face competition from other companies that are working to develop novel drugs and technology platforms using technology similar or in the same field as our’s.

We face competition from other companies that are working to develop novel drugs and technology platforms using technology similar or in the same field as ours.

If these companies develop drugs more rapidly than us, or their technologies, including delivery technologies, are more effective, our ability to successfully commercialize drugs may be adversely affected.

In addition to the competition we face from competing drugs in general, we also face competition from other companies working to develop novel drugs using technology that competes more directly with our own.

We are aware of multiple companies that are working in the field of RNAi therapeutics and or KRAS inhibition, including major pharmaceutical companies such as Bristol Myers Squibb/Mirati;

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.

We are aware of multiple companies that are working in the field of RNAi therapeutics and or KRAS inhibition, including major pharmaceutical companies such as Bristol Myers Squibb/Mirati, Amgen, AstraZeneca, E.I.

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.

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In addition to competition with respect to RNAi and with respect to specific products, we face substantial competition to discover and develop safe and effective means to deliver RNAi based drugs to the relevant cell and tissue types.

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.

In addition, substantial resources are being expended by third parties in the effort to discover and develop a safe and effective means of delivering RNAi-based drugs and into the relevant cell and tissue types, both in academic laboratories and in the corporate sector.

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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.

and Threshold Pharmaceuticals (Threshold) is working to develop therapies that target tumor hypoxia, a common characteristic of the tumor microenvironment.

Even if we successfully develop our product candidates, and obtain approval for them, other non RNAi treatments may be preferred, and we may not be successful in commercializing our product candidates.

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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.

are providers of drug delivery and surface modification technologies to the healthcare industry, including local delivery of drugs from drug eluting stents.

We compete with many companies commercializing and/or working to develop drug delivery systems for specific indications, for example for local ocular (in the eye) release of drugs, including degradable and non-degradable products.

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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.

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.

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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.

In the pharmaceutical and biotechnology industries, most of an innovative product’s commercial value is realized during a market exclusivity period.

In the United States and in some other countries, when market exclusivity expires and generic versions are approved and marketed or when biosimilars are introduced (even if only for a competing product), there are usually very substantial and rapid declines in a product’s revenues.

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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.

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.

Absent relevant patent protection for a product, once the exclusivity period expires, generic or alternative versions can be approved and marketed.

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Further, in December 2023, the Biden Administration released a proposed framework that for the first time proposed that a drug’s price can be a factor in determining that the drug is not accessible to the public and therefore that the government could exercise “march-in rights” and license it to a third party to manufacture.

A comment period on the proposal ran through February 6, 2024, and we are not able to predict whether a final rule will be adopted along the lines proposed and, if adopted, whether the government would seek to exercise march-in rights for any of our products.

A comment period on the proposal ran through February 6, 2024, As of the date of this report, the framework has not been finalized, no binding rule has been adopted, and no federal agency has ever exercised march-in rights on the basis of pricing or access.

We cannot predict whether the U.S.

government will finalize the draft framework in its proposed form, modify it, or seek to exercise march-in rights with respect to any of our current or future products.

Any such actions could adversely affect our intellectual property protection, competitive position, and results of operations.

Patent 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.

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.

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.

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Assuming the other requirements for patentability are met, in the United States prior to March 15, 2013, the first to make the claimed invention is entitled to the patent, while outside the United States, the first to file a patent application is entitled to the patent.

After March 15, 2013, under the Leahy-Smith America Invents Act, or the Leahy-Smith Act, enacted on September 16, 2011, the United States has moved to a first to file system.

The Leahy-Smith Act also includes a number of significant changes that affect the way patent applications will be prosecuted and may also affect patent litigation.

After March 15, 2013, under the Leahy-Smith America Invents Act, or the Leahy-Smith Act, enacted on September 16, 2011, the United States moved to a first to file system.

The Leahy-Smith Act also included a number of significant changes that affect the way patent applications are prosecuted and also affect patent litigation.

The USPTO recently developed new regulations and procedures to govern administration of the Leahy-Smith Act, and accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the operation of our business.

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.

In addition, patent reform legislation may pass in the future that could lead to additional uncertainties and increased costs surrounding the prosecution, enforcement and defense of our patents and pending patent applications.

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Our competitive position may suffer if patents issued to third parties or other third-party intellectual property rights cover our products or elements thereof, or our manufacture or uses relevant to our development plans.

In such cases, we may not be in a position to develop or commercialize products or our product candidate unless we successfully pursue litigation to nullify or invalidate the third party intellectual property right concerned, or enter into a license agreement with the intellectual property right holder, if available on commercially reasonable terms.

In such cases, we may not be in a position to develop or commercialize products or our product candidate unless we successfully pursue litigation to nullify or invalidate the subject third-party intellectual property right or enter into a license agreement with the intellectual property right holder, if available on commercially reasonable terms.

We are also aware of pending patent applications, and there may be others of which we are not aware, that if they result in issued patents, could be alleged to be infringed by our product candidates.

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.

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.

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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.

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.

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Mitchell Shirvan, Dr.

Racheli Malka and Michal Yaron.

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.

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We receive, generate and store significant and increasing volumes of sensitive information, such as health information, insurance information and other potentially personally identifiable information.

We faces a number of risks relative to protecting the computer systems we rely on and this critical information, including loss of access risk, inappropriate use or disclosure, inappropriate modification and the risk of being unable to adequately monitor, audit and modify our controls over our critical information.

We face a number of risks related to protecting the computer systems we rely on and this critical information, including loss of access risk, inappropriate use or disclosure, inappropriate modification and the risk of being unable to adequately monitor, audit and modify our controls over our critical information.

This risk extends to the computer systems and information of any collaboration partners, medical institutions, clinical investigators, CROs, contract laboratories, or other third parties involved in our business.

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Likewise, we rely on third parties for the manufacture of our product candidates and to conduct clinical trials, and similar events relating to their computer systems could also adversely impact our business.

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.

To the extent that any disruption or security breach were to result in a loss of or damage to data or applications, or inappropriate disclosure of personal, confidential or proprietary information, we could incur liability due to delays in the development and commercialization of our product candidates or other business activities and/or due to reputational harm, litigation, regulatory investigations and enforcement, fines and penalties, or increased costs of compliance and system remediation.

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

Our executive offices and research and development facilities are located in Israel.

Our executive offices, employees and management personnel are located in Israel.

Most of our officers and directors are residents of Israel.

Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and its neighboring countries, and between Israel and neighboring terrorist organizations, including Hamas (an Islamist terrorist and political group in the Gaza Strip) and Hezbollah (an Islamist terrorist and political group in Lebanon).

In particular, on October 7, 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets.

Hamas also launched extensive rocket attacks on the Israeli population and industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State of Israel.

These attacks resulted in thousands of deaths and injuries, and Hamas additionally kidnapped many Israeli civilians and soldiers.

Following the attack, Israel’s security cabinet declared war against Hamas and commenced a military campaign against Hamas and these terrorist organizations, in parallel to continued rocket and terror attacks against Israel by Hamas.

Upon the start of the war, the Israeli military began to call-up reservists for active duty.

In parallel with the war against Hamas that began in October 2023, there have been continued hostilities along Israel’s northern border, as the Hezbollah terrorist organization based in Lebanon has conducted rocket, drone, and, more recently, missile attacks against Israel, and there have also been rocket, drone and missile attacks against Israel by the Houthi movement in Yemen as well continued hostilities with various rebel militia groups in Syria and Iraq.

The hostilities with Hezbollah have escalated recently, prompting Israel to send its ground forces into southern Lebanon to destroy terrorist positions and infrastructure used by Hezbollah for attacks on northern and central Israel, which had caused the displacement of residents in northern Israel since early in the war.

In November 2024, a ceasefire was brokered between Israel and Hezbollah.

Iran has furthermore entered the conflict against Israel, shooting ballistic missiles at Israel twice during the current war (on April 13, 2024 and October 1, 2024).

Iran is furthermore widely believed to be developing nuclear weapons, with which it has threatened Israel and is also believed to have a strong influence among extremist groups in the region, such as Hamas in Gaza, Hezbollah in Lebanon, the Houthi movement in Yemen and various rebel militia groups in Syria and Iraq.

There is a risk that other terrorist organizations, including Palestinian military organizations in the West Bank as well as other hostile countries will join the hostilities against Israel.

Such clashes may escalate into a greater regional conflict.

Armed conflicts, terrorist activities or political instability in Israel or in the broader Middle East have been adversely affecting, and could continue to, in a more severe way, adversely affect, business conditions in Israel, and could harm our results of operations and make it more difficult for us to raise capital.

Parties with whom we do business may decline to travel to Israel during periods of heightened unrest or tension, forcing Silexion to make alternative arrangements when necessary in order to meet our business partners face to face.

Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and its neighboring countries, and between Israel and neighboring countries and terrorist organizations active in the region, including Iran and its sponsored terrorist organizations, Hamas (in the Gaza Strip), and Hezbollah (in Lebanon).

In late February 2026, Israel and the United States preemptively attacked Iran, in order to eliminate Iran's nuclear and ballistic missile capabilities, and to target the Islamic fundamentalist regime governing Iran, which has threatened Israel's existence.

As part of this conflict, Iran launched missile attacks throughout Israel.

This war followed upon similar conflicts in June 2025, and in April 2024 and October 2024, during which Iran launched ballistic missile attacks against Israel, and Israel conducted strikes against Iranian military and nuclear infrastructure.

Hezbollah has also joined the attacks against Israel in this latest stage of the Israel-Iranian conflict.

The direct conflicts with Iran have run parallel to, and followed upon, a two-year war (from October 2023 until October 2025) during which Israel was attacked by Hamas and Hezbollah.

and declared war in response, which included ground operations in the Gaza Strip and southern Lebanon.

Other Iranian-sponsored terrorist organizations in the Middle East, including the Houthi terrorist group in Yemen, have also attacked Israel with various types of missiles and drones as part of these conflicts, and Israel has responded with air force attacks.

Nearby in the region, the fall of the Assad regime in Syria led Israel to conduct limited military operations targeting Iranian military assets and infrastructure linked to Hezbollah and other Iran-supported groups.

From the initial stages of these wars, which began on October 7, 2023, until recently, our operations have not been materially adversely affected by this situation, and we have not experienced disruptions to our pre-clinical studies, facilities or the manufacturing or supply of our drug candidates.

That is partially attributable to the fact that some of our core activities, including research and development, clinical, and regulatory, are conducted outside of Israel.

However, if the current stage of these wars extends for a long period of time or expands to other fronts, our operations may be harmed in other manners.

In particular, in the short term, our ability to raise critical financings for our operations may be harmed due to the adverse impact that the current Israel-Iran war has had on the U.S.

capital markets and the ability of our executives to travel outside of Israel in connection with those financing activities.

If that were to continue for an extended period of time, that could adversely affect our financial position, results of operations, and cash flows.

Armed conflicts, terrorist activities or political instability in Israel or in the broader Middle East have adversely affected, and could once again, adversely affect business conditions in Israel, and could harm our results of operations.

Parties with whom we do business may decline to travel to Israel, or we may be unable to travel outside of Israel, during periods of heightened unrest or tension, forcing us to make alternative arrangements when necessary in order to meet our business partners face to face.

In addition, the political and security situation in Israel may result in parties with whom we have agreements involving performance in Israel claiming that they are not obligated to perform their commitments under those agreements pursuant to force majeure provisions in such agreements.

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Any losses or damages incurred by us could have a material adverse effect on our business.

Finally, political conditions within Israel may also affect our operations.

Israel held five general elections between 2019 and 2022, and prior to October 2023, the Israeli government pursued extensive changes to Israel’s judicial system, which sparked extensive political debate and unrest.

To date, these initiatives have been substantially put on hold.

Actual or perceived political instability in Israel or any negative changes in the political environment, may individually or in the aggregate adversely affect the Israeli economy and, in turn, our business, financial condition, results of operations and growth prospects.

It may be difficult to enforce a U.S.

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As a result, it is unclear if, and to what extent, our research and development employees may be able to claim compensation with respect to our future revenue.

As a result, Silexion may receive less revenue from future products if such claims are successful, which in turn could impact our future profitability.

As a result, we may receive less revenue from future products if such claims are successful, which in turn could impact our future profitability.

Risks Related to Ownership of Our Ordinary Shares

If we fail to maintain compliance with Nasdaq continued listing requirements, our shares may be delisted from the Nasdaq Global Market.

To continue to be listed on Nasdaq, we need to satisfy a number of conditions.

On November 19, 2024, we received two letters from the Nasdaq Listing Qualifications Department, each addressing a separate compliance deficiency under the Nasdaq Listing Rules.

The first letter from the Nasdaq Listing Qualifications Department notified us of our non-compliance with Nasdaq Listing Rule 5450(b)(2)(A), which requires a company such as ours whose securities are listed on the Nasdaq Global Market under the “Market Value Standard” to maintain a minimum Market Value of Listed Securities (an “MVLS”) of $50,000,000.

The deficiency was triggered by our MVLS having closed below the minimum level for a period of 30 consecutive business days.

Under Nasdaq Listing Rule 5810(c)(3)(C), we are entitled to a 180-day period, ending on May 19, 2025, to rectify the deficiency.

In order to do so, we must achieve and maintain an MVLS of $50,000,000 or more for at least 10 consecutive business days.

Failure to regain compliance within the 180-day period would result in the delisting of our securities from Nasdaq, although we would have the right to appeal such a delisting to a Nasdaq hearings panel.

The second letter informed us of our deficiency in complying with Nasdaq Listing Rule 5450(b)(2)(C), which requires a minimum Market Value of Publicly Held Shares (an “MVPHS”) of $15,000,000 for continued listing on the Nasdaq Global Market under the “Market Value Standard”.

This deficiency was caused by our MVPHS having fallen below the minimum threshold for the prior 30 consecutive business days.

Under Nasdaq Listing Rule 5810(c)(3)(D), we have 180 calendar days, or until May 19, 2025, to regain compliance, which we can achieve if its MVPHS closes at or above $15,000,000 for at least 10 consecutive business days.

Failure to regain compliance within that 180-day period would result in the delisting of our securities from Nasdaq, subject to our right to appeal to a Nasdaq hearings panel.

As part of our strategy, we may consider applying to transfer the listing of our securities to the Nasdaq Capital Market, subject to our meeting one set of continued listing requirements for that market, which would thereby remedy for us the foregoing listing deficiencies.

There can be no assurance, however, that we will qualify for such a listing transfer, or that we will otherwise successfully regain compliance with the MVLS or MVPHS standards within the allotted timeframe or comply with other standards that will enable us to maintain a listing on the Nasdaq Global Market, or that any appeal, if necessary, will be successful.

Furthermore, no assurance can be given that even if we successfully transfer our listing to the Nasdaq Capital Market or regain compliance with the MVLS or MVPHS standards that we will not again be in violation of Nasdaq’s continued listing standards in the future.

We have historically not been in compliance with minimum bid price rule and had an audit committee compliance deficiency although both have been remedied.

Our failure to meet the relevant listing requirements may result in our securities being delisted from Nasdaq.

If our securities are delisted from Nasdaq, we may seek to list them on other markets or exchanges, or the ordinary shares may trade on the pink sheets.

If we fail to maintain compliance with Nasdaq continued listing requirements, our shares may be delisted from the Nasdaq Capital Market.

To continue to be listed on Nasdaq, we must satisfy a number of ongoing conditions.

On September 23, 2025, we received a letter from Nasdaq (the “ September 2025 Nasdaq Letter ”) confirming that we had restored compliance with the requirements related to our previously outstanding listing rule deficiencies—(i) failure to maintain at least $2.5 million of shareholders’ equity, and (ii) the closing bid price of our ordinary shares having been below the minimum $1.00 level for 30 consecutive trading days prior to July 18, 2025.

This followed a process that began in November 2024, when we received notices of non-compliance with Nasdaq Global Market standards, including requirements for minimum market value of listed securities and minimum market value of publicly held shares, which ultimately led to a hearing before a Nasdaq hearings panel in June 2025 (the “ June 2025 Nasdaq Hearing ”).

Following that hearing, our securities were transferred from the Nasdaq Global Market to the Nasdaq Capital Market on July 8, 2025, where trading has continued under the symbols ”SLXN” and “SLXNW”, respectively.

As described in the September 2025 Nasdaq Letter, we are subject to a mandatory panel monitoring period until September 23, 2026.

If, within that one-year monitoring period, the Nasdaq staff finds our company again out of compliance with the minimum shareholders’ equity requirement, we would not be permitted to provide the Nasdaq staff with a plan of compliance with respect to that deficiency, and the staff would not be permitted to grant additional time to us to regain compliance with respect to that deficiency, nor would we be afforded an applicable cure or compliance period.

Instead, the staff would issue a delist determination letter, and we would have an opportunity to request a new hearing with the initial panel from our June 2025 Nasdaq Hearing or a newly convened hearings panel if the initial panel is unavailable.

While we have successfully addressed all immediate compliance concerns, we must continue to maintain compliance with all Nasdaq Capital Market listing standards.

There can be no assurance that we will maintain compliance with the shareholders’ equity requirement and all other standards for listing on the Nasdaq Capital Market on an ongoing basis.

If our securities are delisted from Nasdaq, we may seek to list them on other markets or exchanges, or the ordinary shares may trade in the over-the-counter markets.

In the event of such delisting, our shareholders’ ability to trade, or obtain quotations of the market value of, our securities would be severely limited because of lower trading volumes and transaction delays.

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Additionally, that may cause the market price of our securities to decline further, and shareholders may lose some or all of their investment.

There can be no assurance that our securities, if delisted from Nasdaq in the future, would be listed on another national or international securities exchange or on a national quotation service, the Over-The-Counter Markets or the pink sheets.

There can be no assurance that our securities, if delisted from Nasdaq in the future, would be listed on another national or international securities exchange or quotation system.

The price of our ordinary shares and our warrants may be volatile, and the value of our ordinary shares and our warrants may decline.

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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;

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;

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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;

general economic political, or market conditions;

other events or factors, including those resulting from war, incidents of terrorism, global pandemics or responses to those events.

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We may be the target of this type of litigation in the future, which could result in substantial expenses and divert our management’s attention.

A 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.

The purchase price per ordinary share to be paid by White Lion for shares that we may elect to issue and sell to it under the White Lion Purchase Agreement will fluctuate based on the market price of our ordinary shares at the time we elect to sell such shares.

Depending on market liquidity at the time, resales of such ordinary shares by White Lion may cause the trading price of our ordinary shares to decrease, and any such decrease could be substantial.

If and when we elect to issue and sell ordinary shares to White Lion, those issuances and sales will result in dilution to the interests of existing holders of our ordinary shares, which dilution may be substantial.

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.

In addition to ordinary shares that may be issued under the White Lion Purchase Agreement, ordinary shares may also be issued upon conversion of amounts outstanding under the A&R Sponsor Promissory Note, in an amount of $3,433,000, due February 15, 2027, that we issued to the Moringa Sponsor in connection with the consummation of the Business Combination.

The conversion prices under the A&R Sponsor Promissory Note relates to the market price of our ordinary shares and/or the price at which we raise capital from equity financings.

The issuance of additional shares under the A&R Sponsor Promissory Note will dilute our other equity holders, which could cause the price of our ordinary shares to decline.

A substantial number of our ordinary shares may be issued pursuant to the ATM Agreement and/or 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.

The purchase price per ordinary share to be paid by public shareholders for shares that we may elect to issue and sell via H.C.

Wainwright under the ATM Agreement (in an aggregate amount of up to $13,170,000 of ordinary shares) will fluctuate based on the market price of our ordinary shares at the time we elect to sell such shares.

Depending on market liquidity at the time, such sales of ordinary shares under the ATM may cause the trading price of our ordinary shares to decrease, and any such decrease could be substantial.

If and when we elect to issue and sell ordinary shares under the ATM Agreement, those issuances and sales will result in dilution to the interests of existing holders of our ordinary shares, which dilution may be substantial.

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.

In addition to ordinary shares that may be issued under the ATM Agreement, ordinary shares may also be issued upon conversion of amounts outstanding under the A&R Sponsor Promissory Note, in an original principal amount of $3.433 million due February 15, 2027, that we issued to the Moringa sponsor in connection with the consummation of the Business Combination.

As of December 31, 2025, following conversion of $1.8 million of the outstanding principal amount in September 2025, the remaining outstanding principal amount under the A&R Sponsor Promissory Note was approximately $1.633 million.

The conversion prices under the A&R Sponsor Promissory Note are based on the market price of our ordinary shares and/or the price at which we raise capital in equity financings.

The issuance of additional ordinary shares upon conversion of the A&R Sponsor Promissory Note will dilute our existing shareholders and could cause the market price of our ordinary shares to decline.

The ordinary shares (including ordinary shares underlying warrants) that are being offered by selling securityholders under registration statements that we currently have in effect represent a substantial percentage of our outstanding ordinary shares, and the sale of such shares, or the perception that such sales may occur, could cause the price of our ordinary shares to be more volatile or decrease.

On October 9, 2024, we filed, and on October 16, 2024, the SEC declared effective, a registration statement on Form S-1 (SEC file number 333-282556), in which we registered with the SEC the sale by selling securityholders named therein of up to 1,705,798 of our ordinary shares and up to 21,112 of our warrants (constituting our private warrants).

On February 12, 2025, we filed a registration statement on Form S-1 (SEC file number 333-284873) under which we seek to register with the SEC the sale by selling securityholders named therein of up to 2,377,030 of our ordinary shares underlying an equivalent number of warrants (which warrants had been issued pursuant to the January 2025 induced warrant exercise transaction).

Depending on market liquidity, resales of ordinary shares and warrants by the selling securityholders under those registration statements (in the case of the last of such registration statement, if and when it is declared effective by the SEC) may cause the trading price of our ordinary shares and warrants to decrease, and any such decrease could be substantial.

Additionally, the sale of a substantial number of ordinary shares or warrants by those selling securityholders, or the perception that such sales may take place, could increase the volatility of the market price of the ordinary shares and warrants and depress the trading price of the ordinary shares and warrants and thereby make it more difficult for us to raise capital by selling equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.

Because 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.

On October 9, 2024, we filed a registration statement on Form S-1 (SEC file number 333-282556), which the SEC declared effective on October 16, 2024, registering the sale by the selling securityholders named therein of up to 113,720 of our ordinary shares and up to 1,408 of our private warrants.

On February 12, 2025 and August 26, 2025, we filed registration statements on Form S-1 (SEC file numbers 333-284873 and 333-289860, respectively), which the SEC declared effective on April 1, 2025 and September 4, 2025, respectively, registering the sale by the selling securityholders named therein of up to 158,469 and 314,859 of our ordinary shares underlying an equivalent number of warrants (which warrants had been issued pursuant to the January 2025 and July/August 2025 induced warrant exercise transactions, respectively).

On October 31, 2025, we filed a registration statement on Form S-3 (File No.

333-291210), which went effective automatically on November 20, 2025, registering the resale by selling securityholders of up to 1,292,348 ordinary shares and up to 372 warrants (which covered the resale of the remaining ordinary shares and warrants covered by those previous two registration statements).

Depending on market liquidity, resales of ordinary shares and warrants by the selling securityholders under these registration statements may cause the trading price of our ordinary shares and warrants to decrease, and any such decrease could be substantial.

Furthermore, the sale of a significant number of ordinary shares or warrants by these selling securityholders, or the perception that such sales may occur, could increase the volatility of the market price of the ordinary shares and warrants, depress their trading price, and make it more difficult for us to raise capital by selling equity or equity-related securities in the future at a time and price that we might otherwise prefer.

Because 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 Silexion ordinary shares for a price greater than that which you paid for it.

We will likely retain future earnings, if any, for future operations, expansion and debt repayment and have no current plans to pay any cash dividends for the foreseeable future.

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As a result, you may not receive any return on an investment in our ordinary shares unless you sell our ordinary shares for a price greater than that which you paid for it.

Following, and as a partial result of, our reverse share split, our ordinary shares may experience extreme price volatility unrelated to our actual or expected operating performance, financial condition or prospects, making it difficult for prospective investors to assess the rapidly changing value of our ordinary shares.

Recently, there have been instances of extreme share price run-ups followed by rapid price declines and strong share price volatility with a number of relatively new public companies, especially among companies with relatively smaller public floats.

As a relatively small-capitalization company with relatively small public float, we may experience greater share price volatility, extreme price run-ups, lower trading volume and less liquidity than large-capitalization companies.

The potential for reduced liquidity was heightened in the aftermath of our 1-for-9 reverse share split effected on November 29, 2024, which may heighten our exposure to those trading trends.

In particular, following the reverse share split, our ordinary shares may be subject to rapid and substantial price volatility, low volume of trades, and large spreads in bid and ask prices.

Such volatility, including any stock run up, may be unrelated to our actual or expected operating performance, financial condition or prospects, making it difficult for prospective investors to assess the rapidly changing value of our ordinary shares.

In addition, if the trading volumes of our ordinary shares are low, persons buying or selling in relatively small quantities may easily influence prices of our ordinary shares.

This low volume of trades could also cause the price of our ordinary shares to fluctuate greatly, with large percentage changes in price occurring in any trading day session.

Holders of our ordinary shares may also not be able to readily liquidate their investment or may be forced to sell at depressed prices due to low volume trading.

If high spreads between the bid and ask prices of our ordinary shares exist at the time of a purchase, the shares would have to appreciate substantially on a relative percentage basis for an investor to recoup its investment.

Broad market fluctuations and general economic and political conditions (including in Israel, where our operations are centered) may also adversely affect the market price of our ordinary shares.

As a result of this volatility, investors may experience losses on their investment in our ordinary shares.

A volatile market price of our ordinary shares also could adversely affect our ability to issue additional ordinary shares or other securities and our ability to obtain additional financing in the future, which is a key strategic goal for us, thereby frustrating our ability to achieve one of the key purposes of our reverse share split.

To the extent we need to effect an additional reverse share split, our ordinary shares may experience extreme price volatility unrelated to our actual or expected performance, making it difficult for investors to assess the value of our ordinary shares.

Recently, several -public companies with low capitalizations have experienced extreme share price volatility, including rapid price increases followed by sharp declines.

As a relatively small-capitalization company with a limited public float, we may experience greater share price volatility, lower trading volume, and less liquidity than companies with larger capitalization.

The potential for volatility is heightened following a reverse share split, such as our 1-for-9 reverse share split effected on November 29, 2024, and our 1-for-15 reverse share split effected on July 29, 2025.

Following a reverse share split, our ordinary shares may be subject to rapid and substantial price fluctuations, low trading volumes, and wide bid-ask spreads.

Such volatility may be unrelated to our actual or expected operating performance or prospects, making it difficult for investors to assess the value of our ordinary shares.

To the extent we need to effect an additional reverse share split in the future in order to maintain compliance with the Nasdaq minimum bid price rule, these volatility factors may adversely affect investors in our ordinary shares.

If trading volumes remain low, small trades could significantly influence the price of our ordinary shares, causing large percentage changes in price during a single trading session.

Shareholders may be unable to readily liquidate their investment or may be forced to sell at depressed prices.

Broad market fluctuations and general economic or political conditions (including those in Israel, where our operations are centered) may also adversely affect the market price of our ordinary shares.

As a result of this volatility, investors may experience losses on their investment.

A volatile market price could also adversely affect our ability to issue additional ordinary shares or other securities and to obtain financing in the future, which is a key strategic objective for us.

We qualify as an “emerging growth company” as well as a “smaller reporting company” within the meaning of the Securities Act, and if we take advantage of certain exemptions from disclosure requirements available to emerging growth companies or smaller reporting companies, it could make our securities less attractive to investors and may make it more difficult to compare our performance to the performance of other public companies.

We qualify as an “emerging growth company” as defined in Section 2(a)(19) of the Securities Act, as modified by the JOBS Act.

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.

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.

In addition, Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the exemption from complying with new or revised accounting standards provided in Section 7(a)(2)(B) of the Securities Act as long as the Company is an emerging growth company.

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.

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.

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.

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.

Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements.

The Company will remain a smaller reporting company until the last day of the fiscal year in which (i) the market value of our ordinary shares held by non-affiliates is equal to or exceeds $250 million as of the end of that year’s second fiscal quarter, or (ii) our annual revenues is equal to or exceeds $100 million during such completed fiscal year and the market value of our ordinary shares held by non-affiliates is equal to or exceeds $700 million as of the end of that year’s second fiscal quarter.

To the extent the Company takes advantage of such reduced disclosure obligations, it may also make comparison of our financial statements with other public companies difficult or impossible.

We will remain a smaller reporting company until the last day of the fiscal year in which (i) the market value of our ordinary shares held by non-affiliates is equal to or exceeds $250 million as of the end of that year’s second fiscal quarter, or (ii) our annual revenues are equal to or exceed $100 million during that fiscal year, or the market value of our ordinary shares held by non-affiliates is equal to or exceeds $700 million as of the end of that year’s second fiscal quarter.

Our taking advantage of these reduced disclosure obligations may make it difficult to compare our financial statements with those of other public companies.

Risks Related to U.S.

Federal Income Taxation

The PFIC status of New Silexion could result in adverse U.S.

The PFIC status of our company could result in adverse U.S.

federal income tax consequences to U.S.

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corporation that owns, directly or indirectly, at least 25% by value of the stock of another corporation is treated as if it held its proportionate share of the assets of the other corporation and received directly its proportionate share of the income of the other corporation.

The annual PFIC income and asset tests in respect of New Silexion will be applied based on the assets and activities of the combined business.

Based on the composition of our income and assets, it cannot be determined whether we will be classified as a PFIC for our current taxable year or in any future taxable year.

The annual PFIC income and asset tests in respect of our company is applied based on the assets and activities of our business.

Based on the composition of our income and assets, it cannot be determined whether we will be classified as a PFIC for 2025 or in any future taxable year.

Further, changes in the composition of our income or composition of our assets may cause us to be or become a PFIC for the current or subsequent taxable years.

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federal income tax consequences and may be subject to additional reporting requirements.

For a further discussion, see “ Certain Material U.S.

Federal Income Tax Considerations — PFIC Rules .” U.S.

Holders are strongly encouraged to consult their own advisors regarding the potential application of these rules to the ownership of our ordinary shares, pre-funded warrants and/or our ordinary warrants.

person is treated as owning at least 10% of the shares of New Silexion, such person may be subject to adverse U.S.

person is treated as owning at least 10% of the shares of our company, such person may be subject to adverse U.S.

federal income tax consequences.

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.

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.

corporation is considered a CFC if more than 50% of (1) the total combined voting power of all classes of stock of such corporation entitled to vote, or (2) the total value of the stock of such corporation is owned, or is considered as owned by applying certain constructive ownership rules, by United States shareholders on any day during the taxable year of such non-U.S.

If the New Silexion Group includes one or more non-U.S.

If the Silexion Group includes one or more non-U.S.

subsidiaries, certain of our non-U.S.

5 unchanged sentences

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.

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.

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.

We may be the target of this type of litigation in the future.

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.

Any adverse determination in litigation could also subject our company to significant liabilities.

Securities class action lawsuits and derivative lawsuits are often brought against public companies that have entered into merger or business combination agreements.

3 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors