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Silexion Therapeutics (SLXN) Risk Analysis
Risk Overview Q2, 2026
Source: the company's latest filing for the period ended Jun 30, 2026, filed Aug 14, 2026
Risk Change Over Time
- Share Price & Shareholder Rights - Risk 1We are currently not in compliance with the Nasdaq continued listing requirements. If we are unable to regain compliance with Nasdaq's listing requirements, our securities could be delisted, which could affect our securities' market price and liquidity, and could also frustrate our ability to complete our initial business combination. the Silexion Business Combination.
On February 20, 2024, we received a written notice (the "Notice") from the Nasdaq Listing Qualifications Department indicating that unless we timely request a hearing before the Nasdaq Hearings Panel (the "Panel"), trading of our securities on the Nasdaq was to be suspended at the opening of business on February 29, 2024, due to our non-compliance with Nasdaq IM-5101-2, which requires that a special purpose acquisition company complete one or more business combinations within 36 months of the effectiveness of its IPO registration statement. We requested a hearing before the Panel, which took place on April 23, 2024 and thereby averted a suspension in trading of the Moringa securities. Based on that hearing, we have been granted a six-month extension, until August 19, 2024, to regain compliance with that Nasdaq listing requirement by consummating the Silexion Business Combination. We cannot assure you that we will be able to regain compliance with Nasdaq IM-5101-2 and maintain compliance with all other Nasdaq continued listing requirements. The sole means to regain compliance and remedy our current non-compliance is to complete the Silexion Business Combination (or any other potential business combination) prior to the end of the extension period. Therefore, if we fail to complete the Silexion Business Combination by the six-month deadline, we will likely be unable to fulfill the closing condition under the Silexion Business Combination Agreement that the New Pubco ordinary shares be accepted for listing on Nasdaq. That, in turn, could lead to the termination of the Silexion Business Combination Agreement, which could cause us to liquidate, as a result of which public shareholders may only receive their proportional share of the current funds in the trust account, or less. Even if we do not liquidate, the delisting of our securities from Nasdaq could adversely affect the market price and liquidity of our securities, which would likely continue to trade in the over-the-counter market instead.
- Corporate Activity and Growth - Risk 2Our search for a proposed business combination opportunity with Silexion, a company located in or connected to Israel Israel, may be subject to a variety of additional risks that may negatively impact either the search process and/or the operations of the combined company.
Because we seek an initial business combination with Silexion, a company that is located in Israel, we may face additional burdens in completing our initial business combination, and if we effect such business combination, we could be subject to a variety of additional risks that may negatively impact the operations of New Pubco. Since the establishment of the State of Israel in 1948, a number of armed conflicts have occurred between Israel and its neighboring countries and terrorist organizations active in the region. These conflicts have involved missile strikes, hostile infiltrations and terrorism against civilian targets in various parts of Israel, which have negatively affected business conditions in Israel. In October 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 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 extensive deaths, injuries and kidnapping of civilians and soldiers. Following the attack, Israel's security cabinet declared war against Hamas and a military campaign against these terrorist organizations commenced in parallel to their continued rocket and terror attacks. Since the commencement of these events, there have been continuous hostilities along Israel's northern border with Lebanon (with the Hezbollah terror organization) and occasional attacks by the Houthi terror organization in Yemen. In addition, on April 13, 2024, Iran launched an aerial attack on Israel through the use of cruise and ballistic missiles along with suicide drones. While Israel repelled the Iranian attack, including through the assistance of the Unites States, France, the United Kingdom, and Jordan, the attack by Iran signaled an escalation in the regional conflict and the potential for larger regional conflict, which may bring additional countries into the sphere of conflict. The intensity and duration of Israel's current war against each of Hamas and Hezbollah, along with any additional regional conflict, is difficult to predict, as are the economic implications of the war on the business and operations on Silexion or any other target company with which we may combine, and on Israel's economy in general. These events may cause wider macroeconomic deterioration in Israel, which may have a material adverse effect on our ability to effectively complete the Silexion Business Combination, or on the operations of New Pubco. In connection with the Israeli security cabinet's declaration of war against Hamas and possible hostilities with other organizations, several hundred thousand Israeli military reservists were drafted to perform immediate military service. Certain of our executives and board members live in Israel, and employees of Silexion, or its service providers, may be located in Israel, and may have been called, or will be called, for service in the current or future wars or other armed conflicts with Hamas, and such persons may be unavailable for extended periods of time. Any armed conflicts, terrorist activities or political instability in the region could adversely affect business conditions, could harm Silexion's results of operations and could make it more difficult for Silexion to raise capital. Parties with whom Silexion does 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 its business partners face to face. In addition, the political and security situation in Israel may result in parties with whom Silexion has 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. Further, in the past, the State of Israel and Israeli companies have been subjected to economic boycotts. Several countries still restrict business with the State of Israel and with Israeli companies. These restrictive laws and policies may have an adverse impact on Silexion's operating results, financial condition or the expansion of its business.
Risk Highlights Q2, 2026
Risk Word Cloud
Risk Factors Full Breakdown - Total Risks 56
- Innovation / R&D - Risk 1Our product candidates may be approved and/or commercialized only in part, only as neoadjuvant therapy, or as an adjuvant therapy.
Our product candidates may be approved by the FDA or other regulatory agencies only as a treatment to be provided in association with other treatments, if at all. For example, it may be possible that our SIL204 be used as adjunct therapy with chemotherapy treatments. Limitation in commercialization of such treatments, including limitations in supply, call-back, clinical holds, changes in medical trends, changes in cost and/or reimbursement policy, may limit our ability to commercialize our product candidates, either directly or via third parties.
- Innovation / R&D - Risk 2Our product candidates and the administration of our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
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. 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 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;- we could be sued and held liable for harm caused to patients; and - our reputation may suffer. 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.
- Innovation / R&D - Risk 3We may find it difficult to enroll patients in our clinical studies. Difficulty in enrolling patients could delay or prevent clinical studies of our product candidates.
Identifying and qualifying patients to participate in clinical studies of our product candidates is critical to our success. The timing of our clinical studies depends in part on the speed at which we can recruit patients to participate in testing our product candidates, and we may experience delays in our clinical studies if we encounter difficulties in enrollment. Some of the conditions for which we plan to evaluate our current product candidates are relatively rare diseases. For example, according to the National Cancer Institute, approximately 61,000 patients were diagnosed with pancreatic cancer in the U.S. in 2020. Accordingly, there are limited patient pools from which to draw for clinical studies. In addition to the relative rarity of these diseases, the eligibility criteria of our clinical studies will further limit the pool of available study participants as we will require that patients have specific characteristics that we can measure or to assure their disease is either severe enough or not too advanced to include them in a study. We also may not be able to identify, recruit, and enroll a sufficient number of patients to complete our clinical studies because of the perceived risks and benefits of the product candidate under study, the availability and efficacy of competing therapies and clinical studies, the proximity and availability of clinical study sites for prospective patients, and the patient referral practices of physicians. In addition, even for the more prevalent diseases which we target, such as prostate and breast cancer, enrolling patients in our clinical studies may be difficult. There may be several ongoing clinical studies for these diseases (both RNAi based and otherwise), and we may face competition in enrolling patients. The number of patients in such clinical studies might be significantly large. In addition, the time period required to achieve indications of safety and efficacy in such studies may be very long. Some of these competing studies may be conducted by other biopharmaceutical companies with more experience in clinical testing and with much greater financial, technical and human resources than we have. If patients are unwilling to participate in our studies for any reason, the timeline for recruiting patients, conducting studies, and obtaining regulatory approval of our potential products will be delayed.
- Innovation / R&D - Risk 4Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of preclinical activity or earlier studies may not be predictive of future study results.
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 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 product candidates. Events that may prevent successful or timely completion of clinical development include but are not limited to: - delays in reaching a consensus with regulatory agencies on study design;- delays in reaching agreement on acceptable terms with prospective contract research organizations (CROs) and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical study sites;- delays in obtaining required Institutional Review Board (IRB) or Ethics Committee approval at each clinical study site;- imposition of a clinical hold by regulatory agencies, after review of an investigational new drug (IND) application, or equivalent application, or an inspection of our clinical study operations or study sites;- difficulty collaborating with patient groups and investigators;- failure by our CROs, other third parties, or us to adhere to clinical study requirements;- 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 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 our deciding, or regulators requiring us, to conduct additional clinical studies or abandon drug development programs; and - failures associated with data interpretation, data management and data storage of such studies. If we ultimately are unable to successfully complete clinical development of our product candidates, we would be forced to cease operations. Clinical study delays could also shorten any periods during which our products have patent protection and may allow our competitors to bring products to market before we do, which could impair our ability to obtain orphan exclusivity and to successfully commercialize our product candidates.
- Innovation / R&D - Risk 5The approach we are taking to discover and develop novel RNAi therapeutics is unproven for oncology and may never lead to marketable products.
We have concentrated our efforts and therapeutic product research on RNAi technology, and RNAi drug delivery, 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 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. 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 profitable, and the value of our ordinary shares may decline. The FDA has relatively limited experience with RNAi and siRNA based therapeutics. 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. We may never receive approval to market and commercialize any product candidate. Further, our focus on RNAi technology for developing drugs, as opposed to multiple, more proven technologies for drug development, increases the risks associated with the ownership of our ordinary shares. If we are not successful in developing a product candidate using RNAi technology, we may be required to change the scope and direction of our product development activities. In that case, we may not be able to identify and implement successfully an alternative product development strategy.
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