Elicio Therapeutics (9HA) Risk Analysis

As with most biological products, use of our product candidates could be associated with side effects or adverse events, which can vary in severity from minor reactions to death and in frequency from infrequent to prevalent. Undesirable side effects caused by any current or future product candidate could cause regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other regulatory authorities. We initiated dosing of the AMPLIFY-201 trial of our 2-peptide formulation of ELI-002 in October 2021, and our 7-peptide formulation of ELI-002, in the Phase 1 of the AMPLIFY-7P trial, began dosing in April 2023. We initiated enrollment of the Phase 2 of the AMPLIFY-7P trial in January 2024, completed the enrollment in December 2024, and have an ongoing Expanded Access Program for ELI-002 7P. We have not yet initiated clinical trials for any other product candidates. The AMPLIFY-201 trial through August 2024, when we stopped the disease-free survival follow up for this study, as well as the AMPLIFY-7P trial to date, have shown ELI-002 to induce mild to moderate side effects, such as fatigue, malaise, injection site reactions and myalgia. If we initiate future clinical trials for any other current or future product candidates or continue to advance the AMPLIFY-7P study, it is likely that there will be new or additional side effects associated with the use of our product candidates. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of these side effects. In such an event, our trials could be suspended or terminated, and the FDA or other regulatory authorities could place a clinical hold or order us to cease further development of or deny approval of a product candidate for any or all targeted indications. Such side effects could also affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences may materially and adversely affect our business and financial condition and impair our ability to generate revenues. Further, clinical trials by their nature utilize a sample of the potential patient population. With a limited number of patients and limited duration of exposure, rare and severe side effects of a product candidate may only be uncovered when a significantly larger number of patients are exposed to the product candidate or when patients are exposed for a longer period of time. If one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, including during any long-term follow-up observation period recommended or required for patients who receive treatment using our products, a number of potentially significant negative consequences could result, including: - regulatory authorities may withdraw or limit their approvals of such products;- regulatory authorities may require the addition of labeling statements, specific warnings or contraindications;- we may be required to create a REMS plan, which could include a medication guide outlining the risks of such side effects for distribution to patients, a communication plan for health care providers, and/or other elements to assure safe use;- we may be required to change the way such products are distributed or administered, or change the labeling of the products;- the FDA or a comparable foreign regulatory authority may require us to conduct additional clinical trials or costly post-marketing testing and surveillance to monitor the safety and efficacy of the products;- we may decide to recall such products from the marketplace after they are approved;- we could be sued and held liable for harm caused to individuals exposed to or taking our products; and - our reputation may suffer. In addition, adverse side effects caused by any therapeutics that may be similar in nature to our product candidates could delay or prevent regulatory approval of our product candidates, limit the commercial profile of an approved label for our product candidates, or result in significant negative consequences for our product candidates following marketing approval. Any of these events could prevent us from achieving or maintaining market acceptance of the affected product candidates and could substantially increase the costs of commercializing our product candidates, if approved, and significantly impact our ability to successfully commercialize our product candidates and generate revenues. Additionally, we may choose or need to abandon development of our product candidates, modify our development plans, limit development to certain uses or subpopulations in which the adverse side effects or other undesirable characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. The occurrence of any of these types of events would have an adverse effect on our business, financial condition, results or operations, and prospects.

From time to time, we may publish interim, topline, or preliminary results from our nonclinical studies and clinical trials. Preliminary and interim results from our clinical trials are not necessarily predictive of final results and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary, interim and topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, preliminary, interim and topline data should be viewed with caution until the final data are available. Material adverse changes in the final data compared to the preliminary, interim or topline data could significantly harm our business prospects. Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or therapeutic product, if any, and us in general. In addition, the information we choose to publicly disclose regarding a particular nonclinical study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular therapeutic product, if any, product candidate or our business. If the preliminary, interim and topline data that we report differs from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.

Product candidates are susceptible to the risks of failure inherent at any stage of product development, including the occurrence of unexpected or unacceptable adverse events or the failure to demonstrate efficacy in clinical trials. Clinical development is expensive and can take many years to complete, and its outcome is inherently uncertain. The results of nonclinical studies, preliminary clinical trial results, and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials. Our product candidates may not perform as we expect, may ultimately have a different than expected impact or no impact at all, may have a different mechanism of action than we initially understand or than we expect in humans, and may not ultimately prove to be safe or effective. The nonclinical and clinical development, manufacturing, packaging, labeling, storage, record-keeping, advertising, promotion, post-approval monitoring and reporting, import, export, marketing and distribution, among other activities, of our product candidates are subject to extensive regulation by the FDA and by comparable health authorities in foreign markets. We are not permitted to market or promote our product candidates in the United States until we receive approval from the FDA of a BLA, or in any jurisdictions outside of the United States until we receive similar authorization from analogous foreign authorities, and we may never receive such regulatory approvals for any of our product candidates. Some of our product candidates have only been tested in a nonclinical setting and while those studies have been subject to certain regulatory requirements in order to support product development and regulatory progression, as such product candidates progress they will require clinical trials (which are subject to much more extensive requirements, including GCP standards), as well as additional manufacturing development, including becoming subject to cGMP regulations as such product candidates progress from nonclinical to clinical settings, before we will be able to submit marketing applications to the applicable regulatory authorities. Even if our product candidates are approved, they may be subject to limitations on the indicated uses and populations for which they may be marketed. They may also be subject to other conditions of approval, may contain significant safety warnings, including boxed warnings, contraindications, and precautions, may not be approved with label statements necessary or desirable for successful commercialization, or may be subject to requirements for costly post-market testing and surveillance, or other requirements, including the submission of a REMS to monitor the safety or efficacy of the products. If we do not receive regulatory authority approval for, and successfully commercialize our product candidates, we will not be able to generate revenue from these product candidates in the foreseeable future, or at all. Any significant delays in obtaining approval for and commercializing our product candidates could have a material adverse impact on our business and financial condition. The process of product candidate development and obtaining marketing approval is expensive, often takes many years and can vary substantially based upon the type, complexity and novelty of the products involved and the conditions that they are intended to treat. The number and nature of nonclinical studies and clinical trials that will be required for regulatory approval also varies depending on the product candidate, the disease or condition that the product candidate is designed to address and the regulations applicable to any particular product candidate. We have not previously submitted a marketing application to the FDA, or a similar marketing application to any comparable foreign authorities, for any product candidate, and we cannot be certain that our product candidates will be successful in clinical trials or receive regulatory approval. In addition to significant clinical testing requirements, our ability to obtain marketing approval for our product candidates depends on obtaining the final results of required nonclinical testing, including characterization of the manufactured components of our product candidates and validation of our manufacturing processes. Regulatory authorities may determine that our product manufacturing processes, testing procedures or facilities are insufficient to justify approval. Approval policies or regulations, or the type and amount of data necessary to gain approval, may change and may vary among jurisdictions. Moreover, regulatory authorities have substantial discretion in the biopharmaceutical approval process, including the ability to refuse to accept an application and to delay, limit or deny approval of a product candidate for many reasons, such as a determination that our data is insufficient for approval, that additional nonclinical studies, clinical trials or other data or development work is necessary, or that our manufacturing processes, controls, or facilities are insufficient. Despite the time and expense invested in the development of product candidates, regulatory approval is never guaranteed. Our product candidates may fail at any stage of preclinical or clinical development, and may also reveal unfavorable product candidate characteristics, including safety concerns or the failure to demonstrate efficacy in initial clinical trials. Further, our product candidates may not receive regulatory approval even if they are successful in clinical trials. Although we have completed preclinical validation, including toxicology testing, for our lead product candidate ELI-002 and anticipate completing the preclinical development necessary to file additional IND applications for other product candidates in the future, we may experience numerous unforeseen events before, during, or as a result of clinical trials that could delay or prevent our ability to commence or complete development, commence or complete clinical trials, receive marketing approval or commercialize our product candidates, including: - we may be unable to generate sufficient nonclinical, toxicology, or other in vivo or in vitro data to support the initiation of clinical trials;- regulators or IRBs or Independent Ethics Committees ("IECs") may not authorize us or our investigators to commence or continue a clinical trial, conduct a clinical trial at a prospective trial site, or amend trial protocols, or may require that we modify or amend our clinical trial protocols;- we, regulators, the IDMC, IRBs, or IECs may recommend or require the suspension or termination of clinical research for various reasons, including non-compliance with regulatory requirements or a finding that participants are being exposed to unacceptable health risks, undesirable side effects, or a failure of the product candidate to demonstrate any benefit to patients, or other unexpected characteristics (alone or in combination with other products) of the product candidate, or due to findings of undesirable effects caused by a chemically or mechanistically similar therapeutic or therapeutic candidate;- new information may emerge regarding our product candidates or technology platform that result in continued development of some or all of our product candidates being deemed undesirable;- we may have delays identifying, recruiting and training suitable clinical investigators or investigators may withdraw from our studies;- we may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites or contract research organizations ("CROs"). Contractual terms can be subject to extensive negotiation, may be subject to modification from time to time and may vary significantly among different CROs and trial sites;- we may have delays in adding new clinical trial sites, or we may experience a withdrawal of clinical trial sites;- potential delays in patient enrollment for clinical trials due to public health emergencies, pandemics, natural disasters, staffing shortages, or other events, which may affect our ability to initiate, conduct ongoing clinical trials, and delay initiation of planned and future clinical trials;- the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate, or participants may drop out of these clinical trials or be lost to follow-up at a higher rate than we anticipate for a number of reasons, such as adverse events, lack of treatment effectiveness, fatigue with the clinical trial process or personal issues;- patients may elect to participate in alternative clinical trials sponsored by our competitors with product candidates that treat the same indications as our product candidates;- patients who enroll in our studies may misrepresent their eligibility or may otherwise not comply with clinical trial protocols, resulting in the need to increase the enrollment size for those studies, or extend the duration of those studies;- there may be flaws in our study design, which may not become apparent until a study is well advanced;- our contractors may fail to comply with regulatory requirements or clinical trial protocols, or meet their contractual obligations to us in a timely manner, or at all, or we may be required to engage in additional clinical trial site monitoring;- regulatory authorities or IRBs or IECs may disagree with the design, including endpoints, scope, or implementation of our clinical trials, or regulatory authorities may disagree with the study patient population, against our intended indications or our interpretation of data from nonclinical studies or clinical trials;- regulatory authorities may disagree with the formulation for our product candidates, or our product candidate dose or dosing schedule;- we may be unable to demonstrate to the satisfaction of regulatory authorities that a product candidate is safe, pure, and potent for any indication;- regulatory authorities may not accept, or we or our clinical trials may not meet, the criteria required to submit clinical data from trials which are conducted outside of their jurisdictions;- the results of clinical trials may be negative or inconclusive, may not meet the level of statistical significance required for, or may not otherwise be sufficient to support marketing approval, and we may decide, or regulatory authorities may require us, to conduct additional clinical trials, analyses, reports, or nonclinical studies, or abandon product development programs;- our product candidates may have undesirable or unintended side effects, toxicities, or other properties or characteristics that preclude marketing approval or prevent or limit commercial use;- we may be unable to demonstrate that a product candidate's clinical and other benefits outweigh its safety risks or otherwise provide an advantage over current standard of care ("SOC") or current or future competitive therapies in development;- the SOC for the indications we are investigating may change, which changes could impact the meaningfulness of our resulting study data or require the initiation of new studies or which may necessitate changes to our ongoing or planned studies;- regulatory authorities may require us to amend our studies, perform additional or unanticipated clinical trials or nonclinical studies or manufacturing development work to obtain approval or initiate clinical trials, or we may decide to do so or abandon product development programs;- regulatory authorities may find that we or our third-party manufacturers do not satisfy regulatory requirements and standards for the facilities and operations used in the manufacture of our product candidates;- the cost of clinical trials of our product candidates may be greater than we anticipate, or we may have insufficient funds for a clinical trial or to pay the substantial user fees required by the FDA or other regulatory authorities upon the filing of a marketing application;- the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate;- we may experience manufacturing failures or adverse shipping events that prevent adequate or timely supply of product candidates or other materials for our ongoing studies;- regulatory authorities may take longer than we anticipate to make a decision on our product candidates;- we may be unable to demonstrate the efficacy and safety of our product candidates to the FDA or other regulatory authorities, due to inaccurate or inconsistent potency assessments, potentially resulting in regulatory delays, additional testing requirements, or even rejection of our product candidates;- changes in regulatory guidelines of the FDA or other regulatory authorities may necessitate modifications to any future biological potency assays we may develop, requiring additional validation studies and potential delays in the development or commercialization of our product candidates; or - changes in or the enactment of the approval policies, statutes, or regulations of the applicable regulatory authorities may significantly change in a manner rendering our nonclinical or clinical data insufficient for approval. Additionally, our clinical trials, to date, have been open-label trials. Our Phase 2 study of AMPLIFY-7P is an open-label, randomized study, where both the patient and investigator know whether the patient is receiving our product candidate or is under observation, which may introduce study bias. Most typically, open-label clinical trials test only the product candidate and sometimes do so at different dose levels. Open-label clinical trials are subject to various limitations that may exaggerate any therapeutic effect as patients in open-label clinical trials are aware when or if they are receiving treatment. In addition, open-label clinical trials may be subject to an "investigator bias" where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received product candidate and may interpret the information of the treated group more favorably given this knowledge. Positive results observed in open-label trials may not be replicated in later clinical trials. Additionally, as patients become aware that they are not receiving our product candidate as part of the trial, they may elect to withdraw from our study and enroll in clinical trials sponsored by our competitors, which may extend our study timeline. Principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and may receive cash or equity compensation in connection with such services. While we take steps to assess for conflicts of interest, it remains possible that these relationships and any related compensation could result in perceived or actual conflicts of interest, or a regulatory authority may conclude that the financial relationship may have affected the interpretation of the trial, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical trial itself may be jeopardized, which could result in the delay or rejection of the marketing application we submit. Any such delay or rejection could prevent or delay us from commercializing our current or future product candidates. Furthermore, we expect to rely on CROs and clinical trial sites to ensure the proper and timely conduct of our clinical trials and data analysis from such trials. Although we expect to enter into agreements governing our CROs' committed activities, we have limited influence over their actual performance. A clinical trial may be suspended or terminated by us, our partners, the IRBs of the institutions in which such trials are being conducted, the IDMC for such trial or by the FDA or other regulatory authorities due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug or therapeutic biologic, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. If we experience delays in the completion of, or termination of, any clinical trial of any of our current or potential future product candidates, the commercial prospects of such product candidate will be harmed, and our ability to generate product revenue from such product candidates will be delayed. In addition, any delays in completing our clinical trials will increase our costs, slow our product development and approval process and jeopardize our ability to commence product sales and generate revenue, and we may not have the financial resources to continue development of the product candidate that is affected or any of our other product candidates. We may also lose, or be unable to enter into, collaborative arrangements for the affected product candidate and for other product candidates that we are developing. Any of these occurrences may materially and adversely affect our business, financial condition, results of operations and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our potential future product candidates. Under the PREA, a BLA or supplement to a BLA for certain biological products must include data to assess the safety and effectiveness of the biological product in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective, unless the sponsor receives a deferral or waiver from the FDA. A deferral may be granted for several reasons, including a finding that the product candidate is ready for approval for use in adults before pediatric studies are complete or that additional safety or effectiveness data needs to be collected before the pediatric studies begin. The FDA may issue a PREA Non-Compliance letter to any sponsor that fails to submit the required pediatric assessments, to seek or obtain a deferral or deferral extension, or to request approval for a required pediatric formulation. Similarly, the European Union, under Regulation (EC) No 1901/2006, requires that sponsors either conduct clinical trials in a pediatric population in accordance with a Pediatric Investigation Plan approved by the Pediatric Committee of the EMA or obtain a waiver or deferral from the conduct of these studies from the Pediatric Committee. For any of our product candidates for which we are seeking regulatory approval in the United States or the European Union, we cannot guarantee that we will be able to obtain a waiver or deferral or, alternatively, complete any required pediatric studies or other requirements in a timely manner, or at all, which could result in associated reputational harm and subject us to enforcement action.

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 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.

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. 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 trial's 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 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-naïve 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.

Because we have limited financial and managerial resources, we focus on research programs and product candidates that we identify for specific indications. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs and product candidates for specific indications may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate.