Elicio Therapeutics, Inc.

Item 1A. Risk Factors

Investing in our common stock involves a high degree of risk. You should carefully consider the risk factors, described in the section titled Risk Factors in the Form 10-K as well as the other information in this Quarterly Report on Form 10-Q, before deciding whether to invest in shares of our common stock. There have been no material changes in our risk factors from those described in the Form 10-K., other than as follows.

Risks Related to the Development of our Product Candidates

Our product candidates are at an early stage of clinical development and may not be successfully developed or commercialized.

In June 2026, we reported topline results from our randomized Phase 2 AMPLIFY-7P study evaluating ELI-002 7P in patients with adjuvant mKRAS-driven PDAC. AMPLIFY-7P did not meet its pre-specified primary DFS endpoint in the intent-to-treat population; however, DFS analysis at three and six months showed early treatment benefit and a stronger treatment effect in subsets of the patient population. We continue to evaluate pre-specified subgroups, including the R0 resected population, and intend to use such results to further refine our development strategy for a planned Phase 3 study in adjuvant PDAC. In addition, based on preliminary post-study observations suggesting that ELI-002 7P-induced immune responses may enhance sensitivity to checkpoint inhibition, we announced our intention to initiate a Phase 1 study evaluating ELI-002 7P in combination with a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor in metastatic mKRAS pancreatic cancer, which we anticipate initiating in the fourth quarter of 2026. Our planned Phase 1 combination study in metastatic PDAC is our near-term priority, while our planned Phase 3 registrational trial in adjuvant PDAC is not expected to commence until we complete an additional capital raise. The pursuit of multiple clinical programs at different stages of development and in different treatment settings including an early-stage combination study in metastatic disease and a potential late-stage registrational trial in the adjuvant setting creates distinct risks and uncertainties at each stage. The results from our AMPLIFY-201 and AMPLIFY-7P studies may not be predictive of outcomes in the planned Phase 1 combination study or Phase 3 trial due to, among other things, differences in study design, patient populations, treatment settings, and combination regimens.

In April 2023, we completed enrollment of the AMPLIFY-201 trial for ELI-002 2P targeting Kirsten rat sarcoma viral oncogene homolog (KRAS) gene mutations, which product candidate also includes ELI-004, our universal AMP-modified CpG adjuvant. In October 2023, we completed enrollment of the AMPLIFY-7P Phase 1 portion of the trial for ELI-002 7P and initiated enrollment of the AMPLIFY-7P Phase 2 portion of the trial in January 2024. In December 2024, we completed enrollment in our AMPLIFY-7P Phase 2 portion of the ELI-002 7P trial and in August 2025, we announced the positive recommendation by the IDMC to continue our AMPLIFY-7P Phase 2 study without modifications to final analysis. In June 2026, we reported topline results from our randomized Phase 2 AMPLIFY-7P study of ELI-002 7P.

All of our other product candidates are in preclinical development and will require substantial further capital expenditures, development, testing, and regulatory approval prior to commercialization. With the limited data on ELI-002, we may not be able to effectively design and execute clinical studies that ultimately support marketing approval. We may encounter substantial delays in our clinical trials, and our clinical trials may fail to demonstrate the safety and efficacy of our product candidates sufficiently to result in any marketable products. Failure to adequately demonstrate the safety and efficacy of our product candidates in clinical development would significantly impact our ability to obtain regulatory approval and would delay, prevent or limit the scope of any regulatory approval, which would adversely affect our business, financial condition, results of operations and prospects.

If any of our product candidates are found to be unsafe or lack efficacy, we will not be able to obtain regulatory approval for them and our business would be materially harmed. For example, if the results of our ongoing or planned clinical trials of ELI-002 7P do not achieve adequate therapeutic results or demonstrate unacceptable toxicity in patients, our development of ELI-002 7P may be halted or delayed, which would materially harm our business.

Even if our clinical trials are initiated, completed and successful, clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in clinical trials have nonetheless failed to obtain regulatory approval. There is no assurance that our current and planned clinical studies, including an adequate and well-controlled clinical study, if needed, will yield data that will demonstrate the safety and efficacy of our product candidates to support marketing approval. The timing and successful completion of clinical trials and submission for marketing approval of our product candidates depend on, among other things, the ability to generate positive results in such trials. In addition, even if such trials are successful, we may need to conduct additional studies, which we have not planned for or budgeted, in order to obtain regulatory approval. Our failure to adequately demonstrate the safety and efficacy of our product candidates in clinical development would significantly impact our ability to generate revenue from product sales and would materially harm our business.

The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors that include, but are not limited to, the costs associated with product manufacturing, formulation, and release, the number of patients that ultimately enroll in clinical trials, the number of clinical sites included in the trials, our ability to enroll a sufficient number of suitable patients for our clinical trials, the efficacy of our product candidates in treating patients, the duration of patient follow-up that is determined to be appropriate in view of the observed clinical response or as may be

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required by applicable regulatory authorities, protocols, the rate of dropout among clinical trial participants, and evolving standards of treatment from newly approved drugs. Accordingly, even if we are able to obtain the requisite financing to fund our development programs, we cannot assure you that our product candidates will be successfully developed or commercialized. Our failure to develop, manufacture or receive regulatory approval for or successfully commercialize any of our product candidates could result in the failure of our business and a loss of all of our stockholders investment.

Our planned Phase 1 study evaluating ELI-002 7P in combination with a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor in metastatic mKRAS pancreatic cancer may present additional safety risks, and the combination of multiple agents may result in unexpected adverse events or tolerability issues.

We intend to initiate a Phase 1 clinical study evaluating ELI-002 7P in combination with a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor in treatment-nave and recurrent metastatic mKRAS pancreatic cancer, which we anticipate initiating in the fourth quarter of 2026. This planned study follows preliminary post-study observations, in a small number of patients from our completed Phase 2 AMPLIFY-7P study, suggesting that ELI-002 7P-induced immune responses may enhance sensitivity to checkpoint inhibition. While we have observed a favorable safety profile for ELI-002 7P as a monotherapy in our AMPLIFY-201 and AMPLIFY-7P studies to date, the safety profile of ELI-002 7P in combination with a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor has not been established in clinical trials. Combination therapies may produce additive or synergistic adverse effects beyond those observed with any single agent alone.

Anti-PD-1 inhibitors carry known risks of immune-related adverse events, including colitis, hepatitis, pneumonitis, endocrinopathies, and dermatologic toxicities, among others. RAS small molecule inhibitors carry their own known toxicities, including hematologic, gastrointestinal, and dermatologic adverse events. The addition of ELI-002 7P, which is designed to stimulate immune responses against mKRAS-mutated cells, to regimens that include these agents may result in novel or unexpected immune-mediated toxicities, exacerbation of known side effects, or unanticipated drug interactions.

If the combination produces unacceptable adverse events or an unfavorable risk-benefit profile, we may need to modify the study design, reduce doses of one or more agents, eliminate a combination arm, or discontinue the combination approach entirely. Regulatory authorities may impose clinical holds or require additional nonclinical or clinical safety data before allowing us to proceed. Any of these events would delay our development timelines, increase our costs, and could have a material adverse effect on our business, financial condition, results of operations, and prospects.

Our planned combination studies depend on the availability and cost of third-party therapeutic agents, including anti-PD-1 inhibitors and RAS small molecule inhibitors, and we may face challenges in securing adequate supply of such agents on acceptable terms.

Our planned Phase 1 combination study in metastatic PDAC requires access to third-party therapeutic agents, including a RAS small molecule inhibitor and/or an anti-PD-1 inhibitor. While certain anti-PD-1 inhibitors are commercially available, the cost of procuring these agents for use in our clinical trials could be significant and may increase our overall development costs. We may need to enter into supply or collaboration agreements with the manufacturers of these agents, and there can be no assurance that such agreements will be available on acceptable terms, or at all. The negotiation of these agreements is often complex, time-consuming, and involves lengthy discussions as well as our managements time and focus. If we experience significant delays in finalizing these agreements, we may need to delay the start of our planned study.

In addition, certain RAS small molecule inhibitors that we may seek to evaluate in combination with ELI-002 7P are not yet commercially available or have only recently received regulatory approval. For agents that are not yet on the market, we would need to enter into supply agreements with the developers of such agents, and there can be no assurance that such agreements will be available on acceptable terms or will be finalized in a timely manner, if at all. Additionally, the willingness and ability of those third parties to supply their product candidates for use in our studies is uncertain and outside of our control. Even for agents that are commercially available or may become so in the near term, supply may be limited or subject to allocation constraints, particularly for agents in high demand.

If we are unable to secure adequate supply of combination agents on acceptable terms, or if supply is interrupted or discontinued, we may be required to delay initiation of our combination study, modify the study design, substitute alternative agents (which may require additional regulatory submissions and approvals), or discontinue the combination approach. Changes in the regulatory status, market availability, or pricing of combination agents could also affect the feasibility and cost of our planned studies. Any of the foregoing could delay our development programs, increase our costs, and have a material adverse effect on our business, financial condition, and results of operations.

If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of subjects who remain in the trial until its conclusion. We may not be able to initiate or continue conducting clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible subjects to participate in these trials.

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The enrollment of patients depends on many factors, including: the patient eligibility criteria defined in the protocol; the size of the patient population required for analysis of the trials primary endpoints; the proximity of patients to study sites; the design of the trial; our ability to recruit clinical trial investigators with the appropriate competencies and experience; our ability to obtain and maintain patient consents; the ability to monitor patients adequately during and after treatment; clinicians and patients perceptions as to the potential advantages and side effects of the product candidate being studied in relation to other available therapies; the risk that patients enrolled in clinical trials will drop out of the trials before completion; and the availability of approved therapeutics effective for the treatment of the relevant disease.

In addition, our ongoing or future clinical trials, including our planned Phase 1 combination study in metastatic PDAC may involve trial designs, treatment settings or therapeutic methodologies with limited precedent in published data to guide our trial design and planning, which could result in the need for additional feedback from, and submissions to, regulatory authorities to obtain authorization for such studies or delays in our current or future study readouts if our planning estimates are incorrect. Our clinical trials also compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors.

Further, our planned Phase 3 registrational trial in adjuvant PDAC is anticipated to target a narrower patient population than the broader KRAS-positive solid tumor populations studied in our earlier trials. The more restrictive eligibility criteria in the adjuvant setting may limit the pool of available patients and slow enrollment. In addition, the extended dosing regimen contemplated for the Phase 3 trial may present patient retention challenges. Patients in the adjuvant setting, who have undergone successful surgical resection and may not have active measurable disease, may be less motivated to enroll in or remain in a clinical trial compared to patients with active metastatic disease. Furthermore, our planned Phase 3 trial will compete for patients with other KRAS-targeting programs in pancreatic cancer, including Phase 3 trials that have completed or are being conducted by well-resourced competitors. These factors, individually or collectively, could result in enrollment delays, increased development costs, or an inability to complete enrollment for our planned Phase 3 trial, which could have a material adverse effect on our business, financial condition, and results of operations.

Because the number of qualified clinical investigators is limited, we may conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which may reduce the number of patients who are available for our clinical trials at such clinical trial sites. Moreover, because our product candidates represent a departure from more commonly used methods for cancer treatment, potential patients and their doctors may be inclined to use conventional therapies, such as chemotherapy, rather than enroll patients in any of our future clinical trials. Our inability to enroll a sufficient number of subjects for our clinical trials would result in significant delays and could require us to abandon one or more clinical trials altogether. Moreover, a significant number of withdrawn subjects would compromise the quality of our data.

Enrollment delays in our clinical trials may result in increased development costs for our product candidates, or the inability to complete development of our product candidates, which could cause our value to decline, limit our ability to obtain additional financing, and materially impair our ability to generate revenues.

We face significant competition in an environment of rapid technological change, and there is a possibility that our competitors may achieve regulatory approval before us or develop therapies that are safer or more advanced or effective than ours, which may harm our financial condition and our ability to successfully market or commercialize any product candidates we may develop.

The development and commercialization of new therapeutic biologics is highly competitive. Moreover, the immunotherapy field is characterized by rapidly changing technologies, significant competition, and a strong emphasis on intellectual property. We will likely face competition with respect to any product candidates that we may seek to develop or commercialize in the future from numerous pharmaceutical and biotechnology organizations, as well as from academic institutions, government agencies and other public and private research organizations for our current and future product candidates. Our commercial success may be reduced or eliminated and our business, financial condition, results of operations, and prospects may be harmed if our competitors develop products that are safer, more effective or less costly than ours.

A number of well-resourced pharmaceutical and biotechnology companies are developing products to inhibit RAS-mutated cancers. These products, as well as marketing campaigns by competitors and clinical trial results with competitive products, could significantly diminish our ability to market and sell ELI-002 7P for RAS-mutated cancers, if approved. For example, Amgen Inc. (Amgen), Bristol Myers Squibb Co. (Bristol Myers), and Revolution Medicines, Inc. (Revolution Medicines), among others, have developed small molecule therapies for the treatment of KRAS-mutated cancer including G12C, G12D, and pan KRAS inhibitors. Other companies in the immunotherapy and cancer vaccine sector include AstraZeneca Plc, BioNTech SE (BioNTech), BridgeBio Oncology Therapeutics, Inc., Boehringer Ingelheim, Bristol Myers, Circio Holding ASA, D3 Bio, Inc., Eli Lilly and Company, Erasca, Inc., Geneos Therapeutics, Inc., Gilead Sciences, Inc., Incyte Corporation, Jacobio Pharmaceuticals Group Co., Ltd., Jiangsu Hengrui Pharmaceuticals Co., Ltd., Merck Co., Inc. (Merck), Moderna, Inc. (Moderna), Roche Holding Ltd./Genentech, Inc. (Roche/Genentech), Revolution Medicines, and Verastem, Inc., among others. While many of these programs are in preclinical stages or Phase 1 clinical trials, Amgen and Bristol Myers have products that are approved by the FDA for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, who have received at least one prior systemic therapy. Moderna and Merck are in a combined

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Phase 3 trial of their personalized cancer vaccine targeting melanoma (mRNA-4157) and BioNTech and Roche/Genentech are in Phase 2 trials of their personalized cancer vaccine targeting pancreatic cancer, colorectal cancer, and bladder cancer (BNT122, RO7198457). In particular, certain competitors pursuing KRAS-targeting therapies in metastatic pancreatic cancer are in late-stage clinical development and may obtain regulatory approval in the near term, potentially before we complete our planned Phase 1 combination study in the metastatic setting or initiate our planned Phase 3 registrational trial in the adjuvant setting. In July 2026, Revolution Medicines announced that its new drug application for its oral RAS(ON) multi-selective inhibitor, daraxonrasib, for pancreatic ductal adenocarcinoma was accepted for review by the FDA for previously treated metastatic PDAC. If one or more competing therapies are approved for metastatic KRAS-mutated PDAC before our product candidates reach the market, the standard of care could shift in ways that may limit the differentiation, commercial potential, and competitive positioning of ELI-002 7P. ELI-002 7P may compete with existing and new therapies that may be approved in the future.

Many of our current or potential competitors, either alone or with their collaboration partners, may have significantly greater financial resources and expertise in research and development, manufacturing, nonclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient enrollment for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize product candidates that are safer, more effective, have fewer or less severe side effects, are more convenient, or are less expensive than the product candidates we may develop or that would render any of our product candidates obsolete or non-competitive. Our competitors also may obtain FDA or other regulatory approval for their product candidates more rapidly than we may obtain approval for our product candidates, which could result in our competitors establishing a strong market position before we are able to enter the market.

Our commercial opportunity may also be reduced or limited if we or our partners are unable to scale up the manufacture of our product candidates to meet clinical or commercial requirements. ELI-002 7P is comprised of eight APIs, including peptides and nucleotides with a lipid modification. The compositions we seek to develop may exhibit poor pharmaceutical properties; additionally, manufacturing, purification, formulation, and stable storage could be challenging.

In addition, we could face litigation with respect to the validity and/or scope of patents relating to our competitors' products. The availability of competitive products could limit the demand and the price we are able to charge for our products. Further, intellectual property protection for the amphiphile components of our product candidates is dynamic and rapidly evolving. The scope of intellectual property protection for our AMP platform may be limited, and its commercial opportunity may be reduced or limited if our competitors are able to acquire or develop the same or similar technologies.