SLXN 10-K & 10-Q changes, risk factors and insider trading

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 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. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial may also adversely affect our business.

We have devoted substantially all of our financial resources to design and develop our product candidates, including conducting preclinical and clinical studies and providing general and administrative support for these operations. To date, we have financed our operations primarily through the sale of equity securities and through royalty-bearing grants that we received from Israel’s Innovation Authority, or the IIA. The amount of our future net losses will depend, in part, on the rate of our future expenditures and our ability to obtain funding through equity or debt financings, strategic collaborations, or grants. 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 candidatecandidate, 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.

We have no products approved for commercialization and hashave never generated any revenue. Our ability to generate revenue and achieve profitability depends on our ability, alone or with strategic collaboration partners, to successfully complete the development of, and obtain the regulatory and marketing approvals necessary to commercialize, one or more of our product candidates. We do not anticipate generating revenue from product sales for the foreseeable future. Our ability to generate future revenue from product sales depends heavily on our success in many areas, including but not limited to:

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 pourour 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.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 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.

As of December 31, 2024,2025, our cash and cash equivalents were $1.2$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 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 it,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:

We have limited cash resources and will need to obtain additional funds in order to satisfy our liquidity needs. SilexionWe 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 actualfuture financial position or results of operations wouldmay have been.be.

Our historical financial results included in this Annual Report do not necessarily 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. 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. 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 Silexion’sOur Product Candidates

We have concentrated our efforts and therapeutic product research on RNAi technology, and RNAi drug deliverydelivery, and our future success depends on the successful development of this technology and products based on it. We have not received regulatory approval to market therapeutics utilizing RNAi based drugs, including siRNAs, the class of molecule we are trying to develop into products. The scientific discoveries that form the basis for our efforts to discover and develop new drugs are relatively new. The scientific evidence to support the feasibility of developing drugs and the delivery of such drugs based on these discoveries is both preliminary and limited. Skepticism as to the feasibility of developing RNAi therapeutics for oncology has been expressed in scientific literature. For example, there are potential challenges to achieving safe RNAi therapeutics based on the so-called off-target effects and activation of the interferon response, and other potential challenges to achieve safe and potent levels of RNAi drugs due to complications associated with drug delivery. In addition, decisions by other companies with respect to their RNAi development efforts may increase skepticism in the marketplace regarding the potential for RNAi therapeutics.

Relatively few product candidates based on these discoveries have ever been tested in animals or humans. siRNAs may not naturally possess the inherent properties typically required of drugs, such as the ability to be stable in the body long enough to reach the tissues in which their effects are required, or the ability to enter cells within these tissues in order to exert their effects. We are currently hashave only limited data, and no conclusive evidence, to suggest that itwe 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. In addition, these compounds may not demonstrate in patients the chemical and pharmacological properties ascribed to them in laboratory studies, and they may interact with human biological systems in unforeseen, ineffective or harmful ways. As a result, we may never succeed in developing a marketable product, we may not become profitableprofitable, and the value of our ordinary shares may decline.

The FDA has relatively limited experience with RNAi and siRNA based therapeutics. LimitedThere have been a limited number of approvals granted approvals to any person or entity, including us, to market and commercialize therapeutics using RNAiRNAi-based based drugsdrugs, 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. We may never receive approval to market and commercialize any product candidate.

To date, we have invested a substantial amount of our efforts and financial resources to: (i) identify and develop our product candidates, including conducting preclinical and clinical studies and providing general and administrative support for these operations; and (ii) develop and secure our intellectual property portfolio for our product candidates. Our future success is dependent on our ability to successfully develop, obtain regulatory approval for, and then successfully commercializecommercialize, one or more product candidates. We currently generate no revenue from sales of any drugs or technology platforms, and we may never be able to develop or commercialize a marketable drug.

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 a Phase II2 study on first-generation Loder and moved on to SIL204. SilexionWe hopesexpect to initiate the next clinical trial with SIL204 during the firstsecond halfquarter 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.

We generally plan to seek regulatory approval to commercialize our product candidates in the United States, the EU and in additional foreign countries. 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, itwe 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.

Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical studies to demonstrate the safety and efficacy of the product candidates in humans. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical study process. 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. 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. There is a high failure rate for drugs and biologics proceeding through clinical studies, and product candidates in later stages of clinical studies may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical studies. A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical studies due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier studies. 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 drugproduct candidates.

Undesirable side effects including toxicology caused by our product candidates could cause us or regulatory authorities to interrupt, delay, or halt clinical studies and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities. For example, there are known immune stimulation and other side effects associated with RNAi. The implantation of SIL204 may entail the use of endoscopic ultrasound (EUS) needles, which may cause pancreatitis, bleeding or other procedural related safety issues. The Phase 2 clinical study with siG12DLoder indicated that Loder treatment was well tolerated. Safety events that were observed were primarily related to procedure, mainly reversible abdominal pain. In addition, the presence of a foreign body such as our SIL204) in human tissue may cause inflammation. Results of our studies could reveal a high and unacceptable severity and prevalence of these or other side effects. In such an event, such studies could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny or withdraw approval of our product candidates for any or all targeted indications.

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. weWe do not currently have product liability insurance and doesdo 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.

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

If oura product candidatescandidate areof ours is approved, theyit 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 oura product candidatescandidate 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.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 productsproduct for indications or uses for which theyit dodoes 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 productsproduct 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.product. An unsuccessful post-marketing study or failure to complete such a study could result in the withdrawal of marketing approval. Furthermore, any new legislation addressing drug safety issues could result in delays in product development or commercialization or increased costs to assure compliance. Foreign regulatory authorities impose similar requirements.

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 theour Companycompany and the results of our operating resultsoperations will be adversely affected.

If any of our product candidates areis approved and they areis found to have been improperly promoted for unapproved uses of those products,uses, we may become subject to significant liability. The FDA and other regulatory agencies or other governmental bodies strictly regulate the promotional claims that may be made about prescription products, such as our product candidates, if approved. In particular, a product may not be promoted for uses that are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling. 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, theywe may become subject to significant liability. The U.S. federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. If we cannot successfully manage the promotion of our product candidates, if approved, we could become subject to significant liability, which would materially adversely affect our business and financial condition.

All entities involved in the preparation of therapeutics for clinical studies or commercial sale are subject to extensive regulation. Components of a finished therapeutic product approved for commercial sale or used in late-stage clinical studies must be manufactured in accordance with current GMP (cGMP) or, in other countries, GMP. These regulations govern manufacturing processes and procedures (including record keeping) and the implementation and operation of quality systems to control and assure the quality of investigational products and products approved for sale. 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,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. Our facilities and quality systems, and those of our collaborators and any third-party contractors, must pass a pre-approval inspection for compliance with the applicable regulations as a condition of regulatory approval of our product candidates or any of our other potential products. In addition, the regulatory authorities may, at any time, inspect a manufacturing facility involved with the preparation of our product candidates or our other potential products or the associated quality systems for compliance with the regulations applicable to the activities being conducted. If these facilities do not pass a preapproval plant inspection, regulatory approval of the products may not be granted or may be substantially delayed until any violations are corrected to the satisfaction of the regulatory authority, if ever.

The regulatory authorities also may, at any time following approval of a product for sale, audit a manufacturing facility. If any such inspection or audit identifies a failure to comply with applicable regulations or if a violation of our product specifications or applicable regulations occurs independent of such an inspection or audit, we or the relevant regulatory authority may require remedial measures that may be costly and/or time consuming for us or a third party to implement, and that may include the temporary or permanent suspension of a clinical study or commercial sales or the temporary or permanent closure of a facility. Any such remedial measures imposed upon us, or third parties with whom we contractcontract, could materially harm our business.

We rely on third parties to conduct itsour 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 itsour product candidates, and our business could be substantially harmedharmed.

We have relied upon and plansplan 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. Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol, legal, regulatory, and scientific standardsstandards, and our reliance on the CROs does not relieve us of our regulatory responsibilities. weWe and our CROs and other vendors are required to comply with cGMP and GLP, which are regulations and guidelines enforced by the FDA, the Competent Authorities of the Member States of the European Economic Area (EEA) and comparable foreign regulatory authorities for all of our product candidates in clinical development. Regulatory authorities enforce these regulations through periodic inspections of study sponsors, principal and other investigators, study sites, and other contractors. If we or any of our CROs or vendors fail to comply with applicable regulations, the clinical data generated in our clinical studies may be deemed unreliableunreliable, and the FDA, EMA, or comparable foreign regulatory authorities may require us to perform additional clinical studies before approving our marketing applications. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical studies comply with Good Clinical Practices (GCP) regulations. In addition, our clinical studies must be conducted with product produced under cGMP/GMP regulations. Our failure to comply with these regulations may require us to repeat clinical studies, which would delay the regulatory approval process.

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-goingongoing 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. CROs may also generate higher costs than anticipated. As a result, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase, and our ability to generate revenue could be delayed.

Switching or adding additional CROs involves additional costcosts and requires management time and focus. In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. 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.product candidates. 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.

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.

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.product candidates. 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. We cannot assure you that we will be able to identify alternate suppliers if the need arises at acceptable quality levels or prices.

We focus a substantial part of our research and product development on treatments for locally advanced pancreatic cancer with certain specific mutations. Given the small number of patients who have this disease with these mutations, it is critical to our ability to grow and become profitable that we continue to successfully identify effected patients. Our projections of both the number of people who have these diseases, as well as the subset of people with these diseases who have the potential to benefit from treatment with our product candidates, are based on our beliefs and estimates. These estimates have been derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations, or market research, and may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of these diseases. The number of patients may turn out to be lower than expected. 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 itsour 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.

Although we intend to rely on third-party manufacturers for the raw materials and products to support our own manufacturing of our product candidates for commercialization, we have not yet entered into agreements with such manufacturers. We may be unable to negotiate binding agreements with the manufacturers to support our commercialization activities at commercially reasonable terms. Additionally, these third partythird-party manufacturers may not be able to supply us with the necessary quantities of these raw materials and products to support our own manufacturing process, or in compliance with cGMP or other pertinent regulatory requirements, and within our planned timeframe and cost parameters, and the development and sales of our products, if approved, may be materially harmed.

The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological change. 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 isare 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. Treatments for cancer currently include surgery, radiation therapy, chemotherapy, hormone therapy, immunotherapy and combined treatment modalities such as chemo-radiotherapy. Other approaches may also emerge for the treatment of any of the disease areas in which we focus.

We have competitors both in the United States and internationally, including major multinational pharmaceutical companies, specialty pharmaceutical companies, and biotechnology companies. 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 when competing against the products of competitors.

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 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. If our future collaborators do not commit sufficient resources to commercialize our future products, if any, and we are unable to develop the necessary marketing capabilities on our own, we will be unable to generate sufficient product revenue to sustain our business. We may be competing with companies that currently have extensive and well-funded marketing and sales operations. Without an internal team or the support of a third party to perform marketing and sales functions, we may be unable to compete successfully against these more established companies.

Even if approval is obtained for a product candidate, we may not generate or sustain revenue from sales or licensing of the product due to factors such as whether the product can be sold at a competitive cost and otherwise accepted in the market. The product candidates that we are developing are based on new technologies and therapeutic approaches. 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’sour product candidates will depend on, among other factors:

Some of our target patient populations are small, and, accordingly, the pricing, coverage, and reimbursement of our respective product candidates, if approved, must be adequate to support our commercial infrastructure. 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,ours, 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. If coverage and reimbursement are not available, or are available only to limited levels, Silexion may not be able to successfully commercialize our product candidates. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize a return on our investment.

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.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;Mirati, Amgen;Amgen, AstraZeneca;AstraZeneca, E.I. Lilly;Lilly, Pfizer, Novartis International AG, and Takeda Pharmaceutical Company Limited and,Limited, and biopharmaceutical/pharmaceutical companies such as Alnylam, Revolutions Medicines;Medicines, Boehringer Ingelheim;Ingelheim, Biomea Fusion Inc;Inc., Tekmira Pharmaceuticals Corporation, Arrowhead Research Corporation, Silence Therapeutics plc, RXi Pharmaceuticals Corporation, Quark Pharmaceuticals, Inc. and Marina Biotech, Inc.

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. 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 basedRNAi-based drugs and into the relevant cell and tissue types, both in academic laboratories and in the corporate sector. Some of our competitors have substantially greater resources than we do, and if our competitors are able to negotiate exclusive access to those delivery solutions developed by third parties, we may be unable to successfully commercialize our product candidates. Also, we compete with companies working to develop non RNAinon-RNAi based treatments for solid tumor cancers. For example, Novartis is working on a SHP2 inhibitor, and Boehringer Ingelheim and Bayer SOS1 inhibitors; and Threshold Pharmaceuticals (Threshold) is working to develop therapies that target tumor hypoxia, a common characteristic of the tumor microenvironment. 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 Also, we compete with companies commercializing and/or working to develop drug delivery systems, including drug delivery systems for local (or regional) release. For example, various companies are working on nanoparticle technologies, although these products would not give the extended-release delivery of SIL204. In addition other companies such as SurModics, Inc. is a provider of drug delivery and surface modification technologies to the healthcare industry, including local delivery of drugs from drug eluting stents. 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.candidates.

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.i.e., non-U.S.) locations relating theto SIL204, which upon grant will provide patent protection in the U.S., E.U. and other international jurisdictions. Our success depends in large part on our ability to obtain and maintain patent and other intellectual property protection in the United States and in other countries with respect to our proprietary technology and products.

In the pharmaceutical and biotechnology industries, the majoritymost of an innovative product’s commercial value is realized during oura 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.

While patent term extensions under the Hatch-Waxman Act in the United States and under supplementary protection certificates in Europe may be available to extend the patent exclusivity term, we cannot provide any assurances that any such patent term extension will be obtained and, if so, for how long. In addition, upon issuance in the United States, any patent term can be adjusted based on certain delays caused by the applicant(s) or the USPTO. For example, a patent term can be reduced based on certain delays caused by the patent applicant during patent prosecution. 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 Silexionus 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.

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, andAs weof arethe date of this report, the framework has not ablebeen tofinalized, 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 athe finalU.S. rulegovernment will be adopted alongfinalize the linesdraft framework in its proposed and,form, ifmodify adopted,it, whether the government wouldor seek to exercise march-in rights forwith 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, policypolicy, 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 patentpatents 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. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. We therefore cannot be certain that we or our licensors were the first to make the invention claimed in our owned and licensed patent or pending applications, or that it or our licensor were the first to file for patent protection of such inventions. 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 includesincluded a number of significant changes that affect the way patent applications will beare prosecuted and may 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 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.

Because the RNAi intellectual property landscape is still evolving, it is difficult to conclusively assess our freedom to operate without infringing on third party rights. There are numerous companies that have pending patent applications and issued patents broadly directed to RNAi generally and to RNAi delivery technologies. Our competitive position may suffer if patents issued to third parties or other third partythird-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 thirdsubject partythird-party intellectual property right concerned, or enter into a license agreement with the intellectual property right holder, if available on commercially reasonable terms. weWe 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 beis brought and beis 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. It is also possible that we have failed to identify relevant third partythird-party patents or applications. For example, U.S. applications filed before November 29, 2000 and certain U.S. applications filed after that date that will not be filed outside the U.S. remain confidential until patents issue. Patent applications in the U.S. and elsewhere are published approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date. Therefore, patent applications covering our product candidates or platform technology could have been filed by others without our knowledge. Additionally, pending patent applications which have been published can, subject to certain limitations, be later amended in a manner that could cover our platform technologies, our product candidates or the use of our product candidates. Third party intellectual property right holders may also actively bring infringement claims against Us. We cannot guarantee that we will be able to successfully settle or otherwise resolve such infringement claims. If we are unable to successfully settle future claims on terms acceptable to us, we may be required to engage in or continue costly, unpredictable and time-consuming litigation and may be prevented from or experience substantial delays in pursuing the development of and/or marketing of our product candidates. 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 infringesinfringe 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.

We may be subject to claims that former employees, collaborators or other third parties have an interest in or right to compensation with respect to our current patent application, future patents or other intellectual property as an inventor or co-inventor. For example, we may have inventorship disputes arise from conflicting obligations of consultants or others who are involved in developing our product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship or claiming the right to compensation. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. To the extent that our employees have not effectively waived the right to compensation with respect to inventions that they helped create, they may be able to assert claims for compensation with respect to our future revenue. As a result, we may receive less revenue from future products if such claims are successfulsuccessful, whichwhich, in turnturn, could impact our future profitability.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets, and other intellectual property protection, particularly those relating to biotechnology products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our current patent applications or future patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiateinitiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

To successfully develop our drug candidates, we must be able to attract and retain highly skilled personnel, including consultants and employees. The retention of their services cannot be guaranteed. Our failure to retain or recruit such professionals might impair our performance and materially affect our technological and product development capabilities and our product marketing ability. Our future success depends to a large extent on the continued services of our senior management and key personnel, including in particular, Ilan Hadar, Dr. Mitchell Shirvan, Dr. Racheli MalkaMalka, Dr. Gadi Sarfati and Michal Yaron. Any loss of the services of members of our senior management or key employees would adversely affect our business. We do not currently maintain key-person insurance on the lives of any of our key personnel.

Our success is largely dependent on the performance of our management team and certain key employees and our continuing ability to attract, develop, motivate and retain highly qualified and skilled employees. Qualified individuals are in high demand, and we may incur significant costs to attract and retain them. The inability to attract suitably qualified personspersons, when needed, could prevent us from executing on our business plan and strategy, and we may be unable to find adequate replacements on a timely basis, or at all.

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 facesface a number of risks relativerelated 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.

Our CROs and certain of our service providers are from time to time,time subject to cyberattacks and security incidents. While we have not to our knowledge experienced any significant system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our or our critical third parties’ operations, it could result in delays and/or material disruptions of our research and development programs, our operations and ultimately, our financial results. For example, the loss of trial data from completed, ongoing or planned trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. 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 uncertaintytensions involving Hamas in Gaza, Hezbollah in Lebanon, Russia and Ukraine,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.

On August 15, 2024, the Closing of the Business Combination by and among Silexion Therapeutics Corp (formerly known as Biomotion Sciences), a Cayman Islands exempted company (also referred to herein as “New Silexion”), Silexion Therapeutics Ltd., an Israeli company (“Silexion”), and Moringa occurred pursuant to the Business Combination Agreement. Unless the context otherwise requires, references to the “Company,” “we,” “us” and “our” in this MD&A generally refer to: (i) for all periods preceding, and through the Closing of, the Business Combination, Silexion,Silexion and,Israel; and (ii) for all periods following the Closing, New Silexion.

We are a Cayman Islands exempted company that was originally formed for the purpose of effectuating the Business Combination and that now serves as a publicly-tradedpublicly traded holding company for each of Silexion (through which our operations are carried out) and Moringa (which has no operations). Our ordinary shares and warrants arewere initially listed on the Nasdaq Global Market and were subsequently transferred to the Nasdaq Capital Market, and are quoted for trading under the trading symbols “SLXN” and “SLXNW”, respectively.

As a clinical stage company, we have not realized any revenues to date. Prior to the Business Combination, Silexionwe financed itsour operations primarily with the net proceeds from private offerings of itsour ordinary shares and convertible preferred shares, convertible financing agreementsagreements, and Simple Agreement for Future Equity (SAFE) financings, andas well as royalty-bearing grants from the Israeli Innovation Authority (the “IIA”). (whichThose grants totaled $5.8 million through December 31, 2024).2025.

Upon the Closing of the Business Combination, we raised $2.0 million via a private investment in public entity (PIPE) financing, wherebyin which Moringa sold to Greenstar, LP, an affiliate of the Moringa sponsor, 22,2231,482 newly issued Moringa ordinary shares,shares at a price of $90.00$1,350.00 per share,share. whichThose shares were converted into an equivalent number of New Silexion ordinary shares at the Closing,Closing. Also inIn connection with the Closing, we also entered into an ordinary share purchase agreement, dated August 13, 2024 and effective as of August 15, 2024 (the “ELOC Agreement”) with White Lion,Lion Capital, LLC (“White Lion”), which provided us with an equity line of credit (the “ELOC”) of up to $15.0 millionmillion. (the “ELOC”).We haveWe utilized the ELOC for financings from time to time sinceduring the early periods following the Closing of the Business Combination, having raised an aggregate of $3.1 million from the ELOC through December 31, 2025, all of which was raised prior to December 31, 2024. The ELOC expired on December 31, 2025.

Since our inception, we have incurred significant operating losses. Our net losses were $11.9 million for the year ended December 31, 2025, and $16.5 million for the year ended December 31, 2024 (consistingin the case of Silexion’s2024, those losses consisted of Silexion Israel’s net losses for all periods through the Business Combination, and the combined company'scompany’s net losses for all periods afterafterwards) were $16.5 million and $5.1 million for the years ended December 31, 2024 and December 31, 2023, respectively.. As of December 31, 2024,2025, we had an accumulated deficit of $43.3$55.2 million (reflecting Silexion’sSilexion Israel’s accumulated deficit for all periods through August 15, 2024 and the combined company'scompany’s accumulated deficit from August 16, 2024 through December 31, 20242025). We have not recognized any revenue to date.

We expect to continue to incur significant expenses and operating losses for the foreseeable future. The net losses itwe incursincur may fluctuate significantly from quarter to quarter. Our expenses will depend on many factors, including the timing and extent of spending to further develop SIL204 and initiate pre-clinical and clinical trials, support research and development efforts, investments in potential additional pipe-linepipeline products, and increased overall compensation as we continue to hire additional personnel. We anticipate that ourOur expenses will increase if and as we:

Research and development expenses include costs directly attributable to the conduct of research and development programs, includingand consist primarily of the cost of payroll and related expenses, payroll taxes and other employee benefits including share-based compensation related to employees, subcontractors,subcontractors lab expenses,costs, preclinical and clinical trials cost, material costs and consulting fees.

General and administrative expenses consist primarily of personnel costs, including share-based compensation related to directors and employees, patent application fees, office space rental costs, and maintenance expenses, external professional service costs, including legal, accounting, audit, finance, insurance, human resource services, travel expenses and other consulting fees.

We expect that ourOur general and administrative expenses have increased, and we expect that they will continue to increase in the futurefuture, toas we fund our continued research and development activities, primarily due to increased headcount to support anticipated growth in the business and due to incremental costs associated with operating as a public company, including costs to comply with the rules and regulations applicable to public companiescompanies, such as costs related to compliance and reporting obligations pursuant to the rules and regulations of the SEC and stock exchange listing standards, public relations, insurance and professional services.

Financial expenses (income),expenses, net

The financeFinance expenses consistedconsist primarily of changes in fair value of financial liabilities measured at fair value, non-cashinterest lossexpenses upon entering into the Business Combination transaction,(income), and exchange rate differences expenses.

We are providing within this section a discussion and analysis of our historical statement of operations data in accordance with accounting principles generally accepted in the United States of America, or GAAP. Because we are a smaller reporting company (as defined under Rule 12b-2 under the Exchange Act), our financial statements and related financial data in this annual report only cover each of the two years ended December 31, 20242025 and 2023.2024. Similarly, the discussion and analysis contained in this Item 7 is limited to a comparison of our results of operations for the years ended December 31, 20242025 and 2023.2024. For our financial statements for the year ended December 31, 2022,2023, and for a discussion and analysis of our results for that year, and a comparison of those results with those of the year ended December 31, 2023,2024, please see our consolidatedannual statements of operationsreport on pageForm F-7010-K andfor the relatedyear notesended inDecember our31, final prospectus dated January 15, 2025,2024, which we filed with the SEC pursuant to Rule 424(b)(4) under the Securities Act on JanuaryMarch 17,18, 2025,2025 (including Item 7 therein). Our financial statements included elsewhere in this annual report, as well as “Management’sthe Discussionfinancial data and Analysisrelated discussion and analysis contained in this MD&A, relate to our financial condition and results of Financialoperations Conditionas of, and Resultsfor ofthe Operations—year Results of Operations— Comparison of Years endedended, December 31, 20232025, as compared to the corresponding information for Silexion (through the Closing of the Business Combination) and/or the combined company (following the Closing) as of, and 2022”for inthe thatyear finalended, prospectus.December 31, 2024.

Research and development expenses increased by approximately $2.1$1.3 million, or 56.8%,22.4%, to $7.1 million for the year ended December 31, 2025, compared to $5.8 million for the year ended December 31, 2024, compared to $3.7 million for the year ended December 31, 2023.2024. The increase resulted mainly from an increase in subcontractors and consultants expenses in an aggregate amount of $3.1 million related to GMP production batches of the active pharmaceutical ingredient (API) and formulation development intended to support initiation of the planned human clinical trial expected in the second quarter of 2026. In addition, we experienced an increase in payroll and payroll-related expenses of $0.3$0.6 million due to additional headcount and increases in salaries as offollowing the Closing of the Business Combination in August 2024, andwhich fromwere reflected for the full year in 2025 compared to only a partial-year period in 2024. This increase was partly offset by a decrease in non-cash share-based compensation expenses in an amount of $2.3$2.4 million, related to employee grants issued around the time of the Closing.Closing Theof increasethe wasBusiness partly offset, by a decreaseCombination in subcontractorsAugust and2024, consultantswhich expenses,did not recur in an amount of $0.6 million.2025.

Financial expenses, net increaseddecreased by approximately $3.5$3.6 million, or 875.0%,92.3%, to $0.3 million for the year ended December 31, 2025, compared to $3.9 million for the year ended December 31, 20242024. comparedThe to $0.4 million for the year ended December 31, 2023. This increasedecrease was mainly due to ana increasedecrease in an amount of $4.8 million inattributable to the one-time non-cash loss upon entering intocompleting the Business Combination transaction in August 2024, which loss did not recur in 2025, offset in part by an increase in financial expenses due to revaluation income of financial instruments (warrants,mainly promissory notes and ELOC) in an amount of $1.2$1.4 million.million in the year ended December 31, 2025.

Net loss increaseddecreased by approximately $11.4$4.6 million, or 223.5%,27.9%, to $11.9 million for the year ended December 31, 2025, compared to $16.5 million for the year ended December 31, 2024, compared to $5.1 million for the year ended December 31, 2023.2024. The increasedecrease was mainlyprimarily due to an increasedecreases in our research and development expenses, general and administrative expenses, and financial expensesexpenses, including significant decreases in non-cash items related to share-based compensation, and transaction costs related to the Closing of the Business Combination transaction in August 2024, which were not repeated in 2025, as partially offset by an increase in our research and costsdevelopment related to becoming a public company.expenses.

Our capital requirements will depend on many factors, including the timing and extent of spending to further develop SIL204 and initiateconduct pre-clinical and clinical trials, support research and development efforts, investments in potential additional pipe-linepipeline products, and increased overall compensation as we continue to hire additional personnel. For the years ended December 31, 20242025 and 2023,2024, we had net losses of $16.5$11.9 million and $5.1$16.5 million, respectively. As of December 31, 2024,2025, our cash and cash equivalents totaled $1.2$6.0 million.

To date, our principal sources of liquidity have evolved together with our progression as a company. As a private company, we (i.e., Silexion Israel) raised proceeds from private offerings of our ordinary shares and convertible preferred shares, grants from the Israeli Innovation Authority, issuance of convertible financing agreements (CFA), and Simple Agreement for Future Equity (SAFE) financings. Upon the Closing of the Business Combination, we raised funds from a PIPE in which Greenstar, LP, an affiliate of the Moringa sponsor, purchased Moringa ordinary shares that converted automatically into New Silexion ordinary shares (as described below under “PIPE Financing”).shares. Following the Closing, as a public company with ordinary shares and warrants registered under the Exchange Act and trading on Nasdaq, we have obtained financingfinancings in anvarious ongoingmanners, manner, from time to time, underincluding the ELOC, pursuant tofollowing, which we have issued ordinary shares to the ELOC Investor which has resold those shares into the open market (asare described below under “ELOC Financing”). We have furthermore completed a registered public offering of ordinary shares and/or pre-funded warrants, along with ordinary warrants, in Januarygreater 2025 (as describeddetail below under “Public Offering via H.C. Wainwright”), and have raised additional funds from the induced exercise of ordinary warrants issued in that offering, which was completed later in January 2025 (please see “Induced Warrant Exercise Transaction” below for further information).:

Based on our current business plan, we believe our current cash and cash equivalents, and anticipated cash flow from operations, will not be sufficient to meet our anticipated cash requirements for the next 12 monthsmonths, but rather only for several months, from the filing date of this annualAnnual report.Report. We will need to raise additional capital to finance our operations, expand our business and pipeline, maintain our compliance with the Nasdaq shareholders’ equity requirement, or for other reasons.

We have lease obligations and other contractual obligations and commitments as part of our ordinary course of business. See “Note 5: Operating Leases” and “Note 7: Commitments and Contingent Liabilities” to our consolidated financial statements for the year ended December 31, 20242025 included in this annual report for information about our lease obligations.

ToWe are addressa bothclinical-stage localizedbiotechnology company developing, through our subsidiaries, RNA interference (RNAi) therapies for cancers driven by mutations in the Kirsten rat sarcoma viral oncogene homolog (“KRAS”). Our approach targets a significant unmet medical need, as treatment innovation for KRAS-driven cancers has historically lagged despite KRAS being one of the most common oncogenic drivers across solid tumors. In pancreatic cancer, for example, approximately 92% of patients have this mutated oncogene. While multiple pharmaceutical companies are pursuing strategies to inhibit KRAS and systemicthereby limit its downstream signaling, disease,our asapproach wellis asdifferentiated by targeting the tumor’sroot densecause desmoplasticof stroma,oncogenic whichsignaling; limitsour lead product candidate, SIL204, is a second-generation siRNA therapy that is engineered to suppress the effectivenessKRAS oncogene itself, preventing the production of currentthe treatments,oncogenic ourprotein. novelWe deliveryutilize approach, which we refer to as an Integratedintegrated Treatmenttreatment Regimen,approach involvesthat combines administering SIL204 both directly into the tumor and systemically via subcutaneous injection, in combination with standard-of-care chemotherapy. In a previous Phase 2 clinical trial with our first-generation siRNA, the combination of siRNA and standard-of-care chemotherapy demonstrated an overall survival benefit compared to standard-of-care chemotherapy alone. Building on preclinical advancements and regimen optimization, we believe SIL204 has the potential to further improve clinical outcomes. During 2025 and the first quarter of 2026, we advanced operational readiness, including the onboarding of external vendors, with the initiation of clinical studies expected in the second quarter of 2026, contingent upon obtaining regulatory clearance.

As a clinical stage company, we havePrior not realized any revenues to date. Prior to the Business Combination, as a private company, we financed our operations primarily with the net proceeds from private offerings of our ordinary shares and convertible preferred shares, convertible financing agreements, and Simple Agreement for Future Equity (SAFE) financings, as well as royalty-bearing grants from the Israeli Innovation Authority (the “IIA”). Those grants totaled $5.8 million through MarchJune 31,30, 2026, all of which was received prior to the Business Combination. Since the Closing of the Business Combination, we have primarily relied upon public offerings and private financings to finance our operations, specifically: public offerings of ordinary shares and/or pre-funded warrants, together with ordinary warrants; sales of ordinary shares into the public market in an ongoing manner under the ATM Agreement; and induced ordinary warrant exercise transactions.

UponInitially as a public company, at the time of the Closing of the Business Combination, we raised $2.0 million via a private investment in public entity (PIPE) financing, in which Moringa sold to Greenstar, LP, an affiliate of the Moringa sponsor, 1,482148 newly issued Moringa ordinary shares at a price of $1,350.00$13,500 per share. Those shares were converted into an equivalent number of Silexion ordinary shares at the Closing. Also Inin connection with the Closing, we also entered into an ordinary share purchase agreement, dated August 13, 2024 and effective as of August 15, 2024 (the “ELOC Agreement”)2024, with White Lion Capital, LLC (“White Lion”),LLC, which provided us with an equity line of credit (the “ELOC”) of up to $15.0 million. We utilized the ELOC for financings from time to time during the early periods following the Closing of the Business Combination, having raised an aggregate of $3.1 million, all of which was raised prior to December 31, 2024. The ELOC expired on December 31, 2025.

DuringSubsequent 2025to andthat thusinitial far in 2026,period, we successfully transitioned to alternative financing transactions,transactions. raisingIn capital via (i) public offerings of ordinary shares and/or pre-funded warrants, together with ordinary warrants, as well as (ii) ordinary warrant exercise transactions, many of which were completed at the time of, or during periods that followed, those public offerings. We completed public offerings in January 2025 and2025, September 2025, and August 2026, we completed public offerings in which we have raised gross proceeds of approximately $5.0 million, $6.0 million and $6.0$2.5 million, respectively, before before deducting placement agent fees and other offering expenses. In connection with the closing of the January 2025 and September 2025 public offerings, investors exercised an aggregate of 42,683 ordinary warrants and 445,000 Series B ordinary warrantswarrants, issued in the respectiverespectively, offerings, which provided us with additional gross proceeds of $0.9 million and $1.78 million in those offerings,million, respectively. As afollow-up follow-up transactions to the firstJanuary 2025 suchand September 2025 public offering,offerings, laterwe completed induced warrant exercise transactions in January 2025 and again at the start of2025, August 2025, weand completedMay transactions for the induced2026, exercise of ordinary warrants, which raised gross proceeds of approximately $3.3 millionmillion, $1.8 million, and $1.8$1.0 million, respectively, before deducting placement agent fees and other offering expenses. As a follow-up primarily to the second such public offering and to the August 2025 induced warrant exercise transaction, in May 2026, we completed a transaction for the induced exercise of ordinary warrants that had been issued in those offerings, which raised gross proceeds of approximately $1.0 million, before deducting placement agent fees and other offering expenses. H.C. Wainwright served as the exclusive placement agent for each of the foregoingthose public offerings and induced warrant exercise transactions. Each of the foregoing financing transactions is described in further detail below in this MD&A under “Liquidity and Capital Resources.”

Since our inception, we have incurred significant operating losses. Our net losses were $2.7$6.3 million and $1.7$3.6 million for the six months and three months ended March 31,June 202630, and 2025,2026, respectively, and $11.9 million for the year ended December 31, 2025. As of MarchJune 31,30, 2026, we had an accumulated accumulated deficit of $57.9$61.5 million (reflecting Silexion Israel’s accumulated deficit for all periods through August 15, 2024 and the combined company’s accumulated deficit from August 16, 2024 through March 31, 2026). We have not recognized any revenue to date.million.

We expect to continue to incur significant expenses and operating losses for the foreseeable future. The net losses we incur may fluctuate significantly from quarter to quarter. Our expenses will depend on many factors, includingincluding, among other matters: the timing and extent of spending tofor our clinical trials, regulatory applications, and any further developdevelopment activities, in each case related to SIL204; the andextent initiateof clinical trials,our supportrelated research and development efforts,activities; our investments in potential additional pipeline products,products; and increasedwhether and overall compensation aswhen we continueretain additional personnel to hireexpand additionalour personnel.operations. Our expenses will increase ifas and asif we:

As described above in this “Overview”Our under “Operations and Financing Activities” and as detailed further in “Liquidity and Capital Resources” of this MD&A below, our financial condition depends on, and is supported by, our ability to fund our operations on an ongoing basis, including through equity financings. Our Nasdaq listing facilitates that ability, as many potential investors or financing sources may be unwilling to consider an investment in our company on reasonable terms-orterms— or at all-ifall— if our ordinary shares and warrants were to be delisted from from Nasdaq. Such a delisting would likely reduce the liquidity of our securities and increase volatility in our trading price.

Past Remedy of Nasdaq Listing Deficiencies, Including Via Hearings Process

AsOur current describedcompliance below,with overthe continued listing requirements of the Nasdaq Capital Market reflects our remediation of deficiencies to which we had been subject, both recently and also during the earlier stages of our history as a public company following the Business Combination. Over the course of 2025, we underwent a hearings process with Nasdaq, which together with various remedial actions that we took (including financing transactions and a reverse share split), restored our compliance with Nasdaq listing rules related to shareholders’ equity and minimum bid price, thereby enabling us to avoid the delisting of our ordinary shares and public warrants from Nasdaq. As of September 25, 2025, we received confirmation from Nasdaq that we had restored our compliance with each such Nasdaq listing requirement, subject to an ongoing mandatory panel monitoring period until September 23, 2026. To the extent we are found to once again be out of compliance with the shareholders’ equity requirement during the monitoring period, we will be subject to an immediate delisting notice, without entitlement to a cure or compliance period, subject to our right to request a new hearing before a hearings panel in order to prevent a delisting of our securities from Nasdaq. The threat of an immediate delisting from Nasdaq materialized on May 22, 2025, when we received a delisting notice from the Nasdaq Listing Qualifications Department in respect of two listing deficiencies that we had been unable to remedy during the six-month cure period since we had initially been notified of those deficiencies, on November 19, 2024. The deficiencies related to our failure to maintain (i) a minimum Marketmarket Valuevalue of Listedlisted Securitiessecurities of $50 million and (ii) a minimum Marketmarket Valuevalue of Publiclypublicly Heldheld Sharesshares of $15 million, in each case for continued listing on the Nasdaq Global Market.Market (on which our securities were initially listed upon completion of the Business Combination). We appealed the delisting notice to a Nasdaq hearings panel, and a hearing was held before the panel on June 26, 2025. On July 7, 2025, we received a favorable decision from the hearings panel, granting our request to remain listed on Nasdaq, subject to certain conditions. Pursuant to the favorable outcome, the listings of our ordinary shares and warrants were transferred from the Nasdaq Global Market to the Nasdaq Capital Market.

Under the terms of the decision reached by the hearings panel, the continued listing of our securities on the Nasdaq Capital Market was conditioned on our fulfillment of the terms of the compliance plan that we had presented to the panel in connection with the June 26, 2025 hearing. That plan was designed to enable us to achieve at least $2.5 million of shareholders’ equity (the “shareholders’ equity requirement”) and thereby comply with the Equity Standard for listing on the Nasdaq Capital Market on a continued basis. The terms of the compliance plan required, in primary part, that on or before September 19, 2025, we demonstrate in a report filed under the Exchange Act our restoration of compliance with, and our expected long-term compliance with, the shareholders’ equity requirement, as to be demonstrated in a balance sheet not older than 60 days to be included in such a filing. We demonstrated that restoration of compliance with the shareholders’ equity requirement in our current report on Form 8-K that we filed with the SEC on September 15, 2025.

Authorized Share Capital IncreaseIncreases as Support for Financing Activities and Financial Condition

We expect to continue to invest in research and development to develop SIL204, includingincluding, subject to our financial capacity, hiring additional employees and continuing the research and development of that product candidate. As a result, we expect that our research and development expenses will continue to increase in the future.

Our general and administrative expenses have increased, and we expect that— subject to our financial capacity— they will continue to increase in the future, as we fund our continued research and development activities, primarily due to increased headcount to support anticipated growth in the business and due to incremental costs associated with operating as a public company, including costs to comply with the rules and regulations applicable to public companies, such as costs related to compliance and reporting obligations pursuant to the rules and regulations of the SEC and stock exchangeNasdaq listing standards, publicinvestor relations, insurance and professional services.

We are providing within this section a discussion and analysis of our historical statement of operations data in accordance with accounting principles generally accepted in the United States of America,America or GAAP.(“GAAP”). Our financial statements included elsewhere in this quarterly report, as well as the financial data and related discussion and analysis contained in this MD&A, relate to our financial condition and results of operations as of, and for the three-month periodand six-month periods ended, June March 31,30, 2026, as compared to the corresponding information as of, and for the three-month periodand six-month periods ended, March 31,June 30, 2025.

Comparison of three-monthsix-month periods ended MarchJune 31,30, 2026 and 2025

The following table summarizes our results of operations for the three-monthsix-month periods ended MarchJune 31,30, 2026 and 2025:

The following table summarizes our research and development expenses for the three-monthsix-month periods ended MarchJune 31,30, 2026 and 2025:

Research and development expenses increased by approximately $0.8$2.0 million, or 133.3%,125.0%, to $1.4$3.6 million for the three-monthsix-month period ended MarchJune 31,30, 2026, 2026, compared to $0.6$1.6 million for the three-monthsix-month period ended MarchJune 31,30, 2025. The increase resulted mainly from an increase in subcontractorssubcontractors’ and consultantsconsultants’ expenses in an aggregate amount of $0.7$1.8 millionmillion, relatedreflecting our operational ramp-up and preparations, required to support the initiation of our Phase 2/3 human clinical trial, which was initiated in July 2026. These expenses primarily arose from toxicology studies andcosts, product development required to support initiation of the planned human clinical trial expected in the second quarter of 2026 includingcosts, GMP manufacturing costs of our drugproduct product.candidate, regulatory approval expenses, Inand addition,contract weresearch experiencedorganization an(“CRO”) increasesetup in share-based compensation expenses of $0.1 million related to executive officers’ grants issued in February 2026, which did not recur in 2025.costs.

The following table summarizes our general and administrative expenses for the three-monthsix-month periods ended MarchJune 31,30, 2026 and 2025:

General and administrative expenses increased by approximately $0.3$0.5 million, or 27.3%,21.7%, to $1.4$2.8 million for the three-monthsix-month period ended MarchJune 30, 31, 2026, compared to $1.1$2.3 million for the three-monthsix-month period ended MarchJune 31,30, 2025. The increase resulted mainly from an increase in professional services costs in an amount of $0.3$0.5 million, primarily related to legal, investorconsultants, relations, press release activities, director compensation, and other expenses associated with the costs of operating as a public company. In addition, share-based compensation expenses increased by approximately $0.2 million related to equity grants to executive officers and directors in February 2026.

Financial expenses (income), net decreased by approximately $0.1$0.4 million, or 100%, to $0$(0.1) million of financial income for the three-monthsix-month period ended MarchJune 30, 31, 20262026, compared to $0.1$0.3 million of financial expenses for the three-month six-month period ended MarchJune 31,30, 2025. The decrease was mainly due to a decrease in the revaluation expenses of financial instruments (mainly promissory notes).

Net loss increased by approximately $1.0$2.1 million, or 58.8 %,50.0%, to $2.7$6.3 million for the three-monthsix-month period ended MarchJune 31,30, 2026, compared to $4.2 $1.7 million for the three-monthsix-month period ended MarchJune 31,30, 2025. The increase was mainly due to an increase in our research and development expenses expenses (mainly related to preparations for the human clinical trialtrial, initiated in July 2026) and an increase to our general and administrative expenses. expenses.This increase was partly offset by a decrease in financial expenses, net, due to the revaluation of financial instruments.