Elicio (Nasdaq: ELTX) Phase 2 ELI-002 refocuses on R0 patients
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Elicio Therapeutics reported detailed results from its randomized Phase 2 AMPLIFY-7P trial of ELI-002 7P in adjuvant mKRAS-driven pancreatic cancer. The study’s primary endpoint of disease-free survival in the intent-to-treat population was not met, but early landmark analyses showed about a 14% absolute DFS benefit during active treatment at 3 and 6 months, with curve separation through 9 months.
Post-hoc analyses highlighted a stronger effect in completely resected R0 patients, where ELI-002 7P achieved a DFS hazard ratio of 0.65 and median DFS of 23.8 months versus 12.8 months for observation. Higher-risk R1 resections were more common in the ELI-002 arm, which the company believes dampened overall results. mKRAS-specific T cell responses strongly correlated with improved DFS, and safety was favorable with no treatment-related discontinuations or deaths. Elicio plans a Phase 3 trial focused on R0 patients with extended dosing and expects current cash to fund operations into the fourth quarter of 2026, while evaluating additional financing and partnering options.
Positive
- Encouraging R0 subgroup efficacy: In completely resected R0 patients (about 84% of the study), ELI-002 7P showed a disease-free survival hazard ratio of 0.65 with median DFS of 23.8 months versus 12.8 months for observation.
- Strong biomarker–outcome link: mKRAS-specific T cell responses strongly correlated with improved DFS (hazard ratio 0.22 in evaluable patients), supporting the biological activity of ELI-002 7P and aligning immune activation with clinical benefit.
- Favorable safety profile: ELI-002 7P had no treatment-related discontinuations or deaths and proportionally fewer adverse events than standard-of-care observation, supporting plans for longer-term dosing and potential combinations.
- Defined Phase 3 strategy and cash runway: The company outlined a registrational Phase 3 focused on R0 patients with extended dosing and expects its current cash and cash equivalents to fund planned operations into the fourth quarter of 2026.
Negative
- Primary endpoint not met: The Phase 2 AMPLIFY-7P trial did not achieve its pre-specified primary disease-free survival endpoint in the overall intent-to-treat population, limiting support for broad use in all enrolled patients.
- Imbalance in higher-risk patients: A greater share of R1 resections, a known adverse prognostic factor, occurred in the ELI-002 7P arm (19% vs. 10%), complicating interpretation and potentially suppressing the overall treatment effect.
- Reliance on post-hoc findings: Key efficacy signals in R0 patients and landmark DFS benefits are post-hoc analyses, which are less robust than pre-specified endpoints and increase uncertainty heading into Phase 3.
- Future trials depend on financing: Initiation of the planned Phase 3 and broader AMP platform development are described as subject to funding and strategic financing or partnering outcomes, adding execution risk.
Insights
Phase 2 missed its main goal, but subgroup and biomarker data support a narrower Phase 3 path.
The randomized AMPLIFY-7P trial in adjuvant mKRAS pancreatic cancer did not reach its pre-specified primary DFS endpoint in the overall intent-to-treat group, which is a setback for broad use. However, landmark analyses during dosing showed around a 14% absolute DFS benefit at 3 and 6 months, indicating early clinical activity.
Post-hoc data in completely resected R0 patients showed a DFS hazard ratio of 0.65 and median DFS of 23.8 vs. 12.8 months, suggesting benefit in lower residual disease. A strong correlation between mKRAS-specific T cell responses and DFS (HR 0.22) supports the drug’s biological activity, and safety was favorable with no treatment-related discontinuations or deaths.
Strategically, Elicio plans a registrational Phase 3 focused on R0 patients with additional dosing, subject to funding. Management also reiterates a cash runway into Q4 2026 and is exploring strategic financing and partnering. The need for external capital and the post-hoc nature of key efficacy signals introduce risk, but the data provide a rationale for a more targeted late-stage program.
8-K Event Classification
2 items: 8.01, 9.01
2 items
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Phase 2 enrollment: 144 patients
R0 DFS benefit: HR 0.65; 23.8 vs 12.8 months
Early DFS landmark: 90.3% vs 76.6%
+5 more
8 metrics
Phase 2 enrollment
144 patients
Randomized AMPLIFY-7P adjuvant mKRAS pancreatic trial across 24 U.S. sites
R0 DFS benefit
HR 0.65; 23.8 vs 12.8 months
Post-hoc DFS in completely resected R0 patients (n=121)
Early DFS landmark
90.3% vs 76.6%
3‑month DFS rates during active treatment, ELI-002 7P vs observation
6‑month DFS landmark
75.7% vs 61.7%
6‑month DFS rates during active treatment, ELI-002 7P vs observation
Immune-response correlation
HR 0.22
mKRAS-specific T cell fold-change >9.17x vs <9.17x, n=90
R1 imbalance
19% vs 10%
Proportion of R1 resections in ELI-002 7P vs observation arms
Cash runway
Into Q4 2026
Expected support for planned operations from current cash and cash equivalents
Treatment-related discontinuations
0 patients
No treatment-related discontinuations or deaths with ELI-002 7P
Key Terms
disease-free survival, R0 resected, minimal residual disease, mKRAS-specific T cell responses, +2 more
6 terms
disease-free survival clinical
"AMPLIFY-7P did not meet the pre-specified primary endpoint of disease-free survival"
Disease-free survival measures the length of time after treatment during which a patient shows no signs or symptoms of the disease. For investors, it is a key clinical result because longer disease-free periods suggest a therapy is effective at preventing recurrence, which can drive regulatory approval, market demand and revenue potential—think of it as how long a repaired item runs without breaking down.
R0 resected clinical
"Post-hoc analysis identified a stronger DFS hazard ratio in the R0, completely resected population"
R0 resected means a surgeon has removed a tumor with no detectable cancer cells left at the edges of the removed tissue, indicating a complete surgical removal. For investors, an R0 result matters because it usually signals a better prognosis, can reduce the need for additional treatments, and can influence clinical trial outcomes and future revenue expectations for companies tied to the therapy or surgical approach—think of it like pulling a stain out of a shirt with none left behind.
minimal residual disease clinical
"MRD: Minimal Residual Disease"
Minimal residual disease (MRD) is the tiny number of cancer cells that remain in the body after treatment, often too few to show up on standard scans but detectable with very sensitive tests. For investors, MRD is important because it predicts the risk of relapse and can determine whether a therapy is seen as effective, influences regulatory and reimbursement decisions, and affects the size and timing of a drug’s market opportunity—like spotting the last weeds that can make a garden regrow if not removed.
mKRAS-specific T cell responses clinical
"Mutant KRAS (“mKRAS”)-specific T cell responses strongly correlated with improved DFS"
adjuvant pancreatic ductal adenocarcinoma clinical
"adjuvant mutant KRAS-driven pancreatic ductal adenocarcinoma and outlining the Company’s refined Phase 3 development strategy"
Phase 3 development strategy clinical
"Findings inform a refined Phase 3 development strategy focused on a defined R0 resected population"
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date of Report (date of earliest event reported): June 15, 2026
(Exact name of registrant as specified in its charter)
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(857 ) 209-0050
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events.
On June 15, 2026, Elicio Therapeutics, Inc. (the “Company”) issued a press release announcing the results from the Company’s randomized Phase 2 AMPLIFY-7P study in adjuvant mutant KRAS-driven pancreatic ductal adenocarcinoma and outlining the Company’s refined Phase 3 development strategy for ELI-002 7P. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference. Attached as Exhibit 99.2 and incorporated by reference is the Company’s conference call presentation of the Phase 2 AMPLIFY-7P results.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit Number | Exhibit Description | |||||||
| 99.1 | Press Release dated June 15, 2026. | |||||||
| 99.2 | Conference Call Presentation dated June 15, 2026. | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Elicio Therapeutics, Inc. | |||||||||||||||||
| By: | /s/ ROBERT CONNELLY | ||||||||||||||||
Date: June 15, 2026 | Robert Connelly President and Chief Executive Officer (Principal Executive Officer) | ||||||||||||||||
Elicio Therapeutics Reports Results from Phase 2 AMPLIFY-7P Study and Outlines Refined Phase 3 Development Strategy for ELI-002 7P in Adjuvant Pancreatic Cancer • AMPLIFY-7P did not meet the pre-specified primary endpoint of disease-free survival (“DFS”) in the intent-to-treat population. • Randomization balanced most prognostic factors between arms. However, the ELI-002 7P arm had a higher proportion of R1 resected (higher residual disease, tumor present at or within 1 mm of surgical margin) patients compared with the observation arm (ELI- 002 7P 19% vs. observation 10%), a known adverse prognostic factor for recurrence. • R1 patients have increased relapse-risk, implying that this imbalance meaningfully and negatively impacted the ELI-002 arm. • Post-hoc analysis identified a stronger DFS hazard ratio in the R0, completely resected population (post-hoc HR 0.65, p=0.048, ELI-002 7P mDFS 23.8 mo vs observation 12.8 mo, n=121). Absolute recurrence rates observed at 18 months were 9.5% lower for the ELI-002 7P arm. • Lower residual disease (R0 completely resected) patients represented approximately 84% of the AMPLIFY-7P study, indicating potential for a significant population with high unmet need. • Mutant KRAS (“mKRAS”)-specific T cell responses strongly correlated with improved DFS, supporting biological activity of ELI-002 7P (HR 0.22, p<0.0001, n=90). • Findings inform a refined Phase 3 development strategy focused on a defined R0 resected population and additional ELI-002 7P dosing, with the potential to address a significant unmet need and market opportunity in the adjuvant setting. • The favorable safety and tolerability profile of ELI-002 7P supports the potential for longer-term administration and combination approaches. • Elicio is evaluating multiple strategic financing and partnering opportunities to support future clinical development. • Elicio will host a conference call today, Monday, June 15, 2026, at 8:30 AM ET. BOSTON, Mass., June 15, 2026 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or the “Company”), a clinical-stage biotechnology company developing next- generation immunotherapies for mKRAS-driven cancers, today reported results from its randomized Phase 2 AMPLIFY-7P study evaluating ELI-002 7P in patients with adjuvant mKRAS-driven pancreatic ductal adenocarcinoma (“PDAC”) following completion of standard locoregional therapy. The AMPLIFY-7P study did not meet its pre-specified primary DFS endpoint in the intent-to-treat population. However, landmark analyses during active ELI-002 7P treatment indicated early treatment benefit. Post-hoc landmark analyses showed a consistent ~14% absolute DFS benefit during active treatment at both 3 and 6 months, suggesting early clinical activity, with treatment- arm separation persisting through 9 months.
While nodal status, the prespecified stratification factor, was balanced between treatment arms, a higher proportion of patients with the adverse prognostic factor, R1 resection status, were included in the ELI-002 7P arm (19% vs. 10%). Post-hoc analyses showed significant DFS improvement (R0: HR 0.65, p=0.048, n=121) in lower residual disease patients. Importantly, this subgroup represented approximately 84% of enrolled patients. Currently, there are no approved therapies following locoregional treatment. The study informed a refined Phase 3 development strategy focused on a defined, lower residual disease, R0 resected population with additional dosing. The study also demonstrated a strong association between mKRAS-specific immune responses and clinical outcomes (HR 0.22, p<0.0001, n=90), supporting the biological activity of ELI-002 7P. "While AMPLIFY-7P did not meet its primary endpoint in the intent-to-treat study population, promising efficacy signals in patients with lower residual disease burden sharpen our path forward," said Robert Connelly, President and Chief Executive Officer of Elicio. "We identified the patients who benefit most, validated the biology, and demonstrated a favorable safety profile that supports extended dosing in Phase 3. In a disease where no approved options exist after surgery, we believe AMPLIFY-7P demonstrates that ELI-002 7P, an mKRAS-targeted immunotherapy, can generate robust immune responses associated with improved clinical outcomes." Christopher Haqq, M.D., Ph.D., Executive Vice President, Head of Research and Development and Chief Medical Officer of Elicio, added, "The AMPLIFY-7P trial generated important clinical and biological insights that have sharpened our development strategy and strengthened our conviction in ELI-002 7P. The stronger treatment effect observed in completely resected R0 patients, combined with the robust relationship between KRAS-specific T-cell responses and clinical outcomes, supports a clear Phase 3 path focused on patients most likely to benefit from treatment. We look forward to discussing these findings with regulators and believe the results provide important support for the broader application of AMP-enabled immunotherapies across multiple oncogenic drivers." Eileen M. O’Reilly, MD, FASCO, Winthrop Rockefeller Endowed Chair in Medical Oncology Memorial Sloan Kettering Cancer Center, said, “Future progress in pancreatic cancer will increasingly depend on precision medicine approaches that identify patients most likely to benefit from targeted and immune-based therapies. These findings show the promise of immunological targeting of mKRAS in patients previously considered to be refractory to immunotherapy.” The AMPLIFY-7P study enrolled 144 patients across 24 U.S. sites and evaluated ELI-002 7P versus observation in patients with resected Stage I-III mKRAS-driven PDAC who had completed surgery and standard locoregional therapy and were radiographically free of disease at enrollment. Key Findings from AMPLIFY-7P
• Post-hoc landmark analyses demonstrated a ~14% absolute improvement in DFS rates during active treatment at both 3 months (90.3% vs. 76.6%, p=0.022) and 6 months (75.7% vs. 61.7%, p=0.056). • Randomization was stratified by nodal status; however, there was an imbalance in baseline R1 resection status, a known adverse prognostic factor, which disproportionately favored the observation arm (ELI-002 7P 19% vs. observation 10%). • Multivariable analyses identified R1 resection as an adverse prognostic factor for recurrence (HR 1.56, p=0.181). • Post-hoc analyses demonstrated stronger treatment effect in the R0 resected patient population (HR 0.65, p=0.048, n=121). • mKRAS-specific T cell responses strongly correlated with improved DFS, with patients demonstrating the strongest immune responses experiencing the most favorable outcomes (T cell fold change from baseline, >9.17x vs <9.17x: HR 0.22, p<0.0001, n=90 evaluable). • ELI-002 7P demonstrated a favorable safety profile with no treatment-related discontinuations or treatment-related deaths. ELI-002 7P treatment was associated with proportionally fewer adverse events than SOC observation. Phase 3 Development Strategy Insights from AMPLIFY-7P have enabled Elicio to refine its Phase 3 development strategy, focusing on patients with the greatest potential to benefit from treatment and extending treatment duration to enhance the durability of anti-tumor immunity. Subject to financing, the Company plans to initiate a Phase 3 study with the following key elements: • Enrollment of R0 resected patients following completion of standard locoregional therapy • Additional dosing beyond the initial ELI-002 7P immunization and booster regimen • A registrational study with a primary endpoint of DFS Cash Runway As previously guided, the Company expects its current cash and cash equivalents to support planned operations into the fourth quarter of 2026. Elicio is currently evaluating multiple strategic financing and partnership opportunities to advance its planned Phase 3 adjuvant PDAC program and broader AMP platform. Conference Call and Webcast Details
Elicio will host a conference call and webcast beginning at 8:30 AM ET today, June 15, 2026. The live webcast may be accessed HERE. The conference call can be accessed by dialing toll- free 1-877-407-9208 or 1-201-493-6784 (international). The conference call ID is 13761190. A replay of the webcast will be available on the “EVENTS” tab in the Investors section of the Company’s website. About ELI-002 Elicio’s lead product candidate, ELI-002, is a structurally novel investigational AMP cancer immunotherapy that targets cancers that are driven by mutations in the KRAS-gene—a prevalent driver of many human cancers. ELI-002 is comprised of two powerful components that are built with Elicio’s proprietary AMP technology consisting of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant that is available as an off-the-shelf subcutaneous administration. ELI-002 7P (7-peptide formulation) was evaluated in the randomized Phase 2 AMPLIFY-7P trial in patients with mKRAS-driven pancreatic cancer (NCT05726864). The Phase 2 AMPLIFY-7P trial included patients with mKRAS-positive pancreatic cancer who completed standard therapy but remain at high risk of relapse. Based on topline results and post-hoc analyses, Elicio has refined its Phase 3 development strategy to focus on patients with lower residual disease burden and extended treatment duration. At the time of the Phase 2 AMPLIFY-7P analysis, data for overall survival remained immature. The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations present in 25% of all solid tumors, thereby increasing the potential patient population for ELI-002. About the AMP Platform Elicio’s proprietary AMP platform delivers investigational immunotherapy directly to the “brain center” of the immune system – the lymph nodes. Elicio believes this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In pre-clinical models, Elicio observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. Elicio believes its AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based on preclinical studies. Elicio’s AMP platform, originally developed at the Massachusetts Institute of Technology, has broad potential in the cancer space to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.
The AMP platform has been shown to deliver immunotherapy directly to the lymph nodes by latching on to the protein albumin, found in the local injection site, as it travels to lymphatic tissue. About Elicio Therapeutics Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company advancing novel immunotherapies for the treatment of high-prevalence cancers, including mKRAS-positive pancreatic and colorectal cancers. Elicio intends to build on recent clinical findings in the personalized cancer immunotherapy space to develop effective, off-the-shelf immunotherapies. Elicio’s AMP technology aims to enhance the education, activation and amplification of cancer- specific T cells relative to conventional immunotherapy strategies, with the goal of promoting durable cancer immunosurveillance in patients. Elicio’s ELI-002 7P lead program is an off-the- shelf immunotherapy candidate targeting the most common KRAS mutations, which drive approximately 25% of all solid tumors. Off-the-shelf immunotherapy approaches have the potential benefits of low cost, rapid commercial scale manufacturing, and rapid availability of drug to patients, especially in neo-adjuvant settings and for prophylaxis in high-risk patients, contrary to personalized immunotherapy approaches. ELI-002 7P was evaluated in the randomized Phase 2 AMPLIFY-7P trial in patients with mKRAS-positive pancreatic cancer who completed standard therapy, but remain at high risk of relapse. Based on topline results and post-hoc analyses, Elicio has refined its Phase 3 development strategy to focus on patients with lower residual disease burden and extended treatment duration. ELI-002 also has been studied in patients with mKRAS-positive colorectal cancer (“CRC”) in Phase 1 studies. In the future, Elicio plans to expand ELI-002 7P to other indications, including mKRAS positive lung cancer and other mKRAS positive cancers. Elicio’s pipeline includes additional off-the-shelf therapeutic cancer immunotherapy candidates, including ELI-007 and ELI-008, that target BRAF-driven cancers and p53 hotspot mutations, respectively. For more information, please visit www.elicio.com. Cautionary Note on Forward-Looking Statements Certain statements contained in this communication regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. These include statements regarding the sufficiency of Elicio’s current cash and cash equivalents to support planned operations into Q4 2026; Elicio’s planned clinical programs, including the timing and outcome of planned clinical trials; the timing and potential outcome of discussions with regulators regarding the results of the AMPLIFY-7P trial and plans for an ELI-002 7P Phase 3 trial; the potential for advancement of ELI-002 7P into a Phase 3 trial, including the timing and design of any such trial; the potential for clinical benefit, particularly for R0 resected pancreatic cancer patients; the promise of immunological targeting of mKRAS in patients considered to be refractory to immunotherapy; the potential of Elicio’s product candidates, including the potential of ELI-002 7P; the potential market opportunity for ELI-002 7P; the potential for ELI-002 7P to address a significant unmet need in the adjuvant
PDAC setting; the timing and outcomes of any financing or partnering opportunities; the potential for future expansion of ELI-002 to other indications, including in mKRAS positive lung cancer and other mKRAS positive cancers; the potential benefits and effectiveness of off-the- shelf immunotherapy approaches; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Elicio undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. Elicio uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. Such forward-looking statements are based on Elicio’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, Elicio’s plans to develop and commercialize its product candidates, including ELI-002 7P; the timing of initiation of Elicio’s planned clinical trials; the timing of the availability of data from Elicio’s clinical trials; the timing of any planned investigational new drug application or new drug application; Elicio’s plans to research, develop and commercialize its current and future product candidates; and Elicio’s estimates regarding future revenue, expenses, capital requirements and need for additional financing. New factors emerge from time to time, and it is not possible for Elicio to predict all such factors, nor can Elicio assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. These risks are more fully discussed under the heading “Risk Factors” in Elicio’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 12, 2026, as updated by subsequent reports and other documents filed from time to time with the SEC. Forward-looking statements included in this release are based on information available to Elicio as of the date of this release. Elicio does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this release, except to the extent required by law. Investor Relations Contact Brian Ritchie LifeSci Advisors (212) 915-2578 britchie@lifesciadvisors.com Media Contact Michael Fitzhugh
LifeSci Communications (415) 269-7757 mfitzhugh@lifescicomms.com
AMPLIFY-7P Defining the Path Forward for ELI-002 7P in Adjuvant mKRAS PDAC JUNE 15, 2026
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Forward-Looking Statements Certain statements contained in this Presentation regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. These include statements regarding the sufficiency of our current cash and cash equivalents to support planned operations into Q4 2026; our planned clinical programs, including the timing and outcome of planned clinical trials; the timing and potential outcome of discussions with regulators regarding the results of the AMPLIFY-7P trial and plans for an ELI-002 7P Phase 3 trial; the potential for advancement of ELI-002 7P into a Phase 3 trial, including the timing and design of any such trial; the potential for clinical benefit, particularly for R0 resected pancreatic cancer patients; the promise of immunological targeting of mKRAS in patients considered to be refractory to immunotherapy; the potential of our product candidates, including the potential of ELI-002 7P; the potential market opportunity for ELI-002 7P; the potential for ELI-002 7P to address a significant unmet need in the adjuvant PDAC setting; the timing and outcomes of any financing or partnering opportunities; the potential for future expansion of ELI-002 to other indications, including in mKRAS positive lung cancer and other mKRAS positive cancers; the potential benefits and effectiveness of off-the-shelf immunotherapy approaches; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. We use words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. Such forward-looking statements are based on our expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, our plans to develop and commercialize our product candidates, including ELI- 002 7P; the timing of initiation of our planned clinical trials; the timing of the availability of data from our clinical trials; the timing of any planned investigational new drug application or new drug application; our plans to research, develop and commercialize our current and future product candidates; and our estimates regarding future revenue, expenses, capital requirements and need for additional financing. New factors emerge from time to time, and it is not possible for us to predict all such factors, nor can we assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. These risks are more fully discussed under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 12, 2026, as updated by subsequent reports and other documents filed from time to time with the SEC. Forward- looking statements included in this Presentation are based on information available to us as of the date of this Presentation. We do not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this Presentation, except to the extent required by law. 2 | Elicio Therapeutics
DFS curves separated early during active ELI-002 7P treatment, supporting biological activity in the adjuvant setting Strong treatment effect observed in lower residual disease patient populations, supporting a more focused development strategy Strong mKRAS-specific immune responses correlated with DFS; ELI-002 7P maintained a favorable safety profile Randomized Phase 2 AMPLIFY-7P did not achieve its primary DFS endpoint in the overall ITT population in mKRAS-driven PDAC after locoregional therapy: adjuvant setting AMPLIFY-7P Identified a Clear Phase 3 Development Path for ELI-002 7P 3 Clear Clinical Signal in Completely Resected (R0) Patients Biological Validation and Favorable Safety Primary Endpoint was Not Met Early DFS Benefit Observed Findings identify a clear development pathway with refined patient selection and extended treatment duration. Primary endpoint was not met in the ITT population, the study identified a biologically and clinically consistent signal that informs future development | Elicio Therapeutics
AMPLIFY-7P: Randomized Phase 2 Trial in Adjuvant mKRAS+ PDAC 4 CLINICAL STUDY OVERVIEW: NCT05726864 (2:1 Randomized) Note: DFS assessment by iRECIST (new lesions confirmed by biopsy/imaging); R0/R1: Absence or presence of microscopic residual disease; NED: No Evidence of Disease. MRD: Minimal Residual Disease. PD: Progressive Disease N=96 N=48 R 2:1 Optional crossover @ confirmed PD N=144 pts, 24 enrolling U.S. Sites ELI-002 7P Monotherapy 8wk immunization (1,2,3,4,6,8) 8wk observation, 4wk boosting Designed to evaluate whether ELI-002 7P could improve disease-free survival following standard locoregional therapy Standard of Care: Observation ELI-002 7P Monotherapy • 7 mKRAS peptide antigens Phase 2: Key Criteria • Includes: mKRAS G12D/R/V/C/A/S/G13D • Resected Stage I–III mKRAS PDAC • Complete R0/R1 resection • Radiographic NED status within 6 months • MRD agnostic (biomarker +/- included) • Enrollment Completed December 2024 • 144 patients randomized across 24 U.S. Sites Endpoints Primary Endpoint: Disease Free Survival (DFS) Tumor Biomarker Response (biomarker subset) Overall Survival, Safety Exploratory: Immunogenicity | Elicio Therapeutics
Early DFS Separation Observed Through 9 Months 1 5 Post-hoc 3-month and 6-month landmark analyses indicate early clinical activity, with treatment-arm separation persisting through 9 months Su rv iv al P ro ba bi li ty ELI-002 7P DFS: ITT Stratified 20-APR-2026DCO 23.8 (9.8, NE)ELI-002 7P Median DFS (Months) 21.2 (5.1, NE)SOC (Observation) 0.85 HR (95% CI) (0.52 – 1.41) 0.5329P-value ELI-002 7P DFS: Post-hoc Landmark Analysis 6 mo3 moLandmark 75.7%90.3%ELI-002 7P DFS Rate 61.7%76.6%SOC (Observation) 14.0%13.7%DFS Rate Difference 0.05570.0222P-value 0.550.37HR from t0 to Landmark ELI-002 7P Dosing Period 1 Primary DFS analyses used specified stratified Logrank test; DCO: Data cut-off| Elicio Therapeutics
Stronger Treatment Effect Observed in Lower Residual Disease Patient Population 1 6 Post-hoc analyses demonstrate stronger treatment effect in lower residual disease Clear improvement in DFS hazard ratio observed in R0 resected patients (N=121). While post-hoc, these analyses clearly identify the population Elicio believes is most appropriate for Phase 3 evaluation. At 84% of the enrolled population, this represents a clinically meaningful and accessible Phase 3 target. ITT HR = 0.79 P = 0.2492, N = 144 R0 Resected HR = 0.65 P = 0.0484, N = 121 | Elicio Therapeutics 1 Unstratified analyses, Wilcoxon Primary DFS analyses used specified stratified Logrank test; ITT HR 0.85.
Higher Recurrence Risk Lower Recurrence Risk Resection Margin Status Was Imbalanced at Baseline 7 The ELI-002 7P arm contained more high recurrence-risk R1 patients than the observation arm Total (N=144) SOC (N=48) ELI-002 7P (N=96)Characteristic 23 (16%)5 (10%)18 (19%)Resection margin R1 19% 10% 0 5 10 15 20 ELI-002 7P Observation R1 Resection % R1 resection was disproportionately concentrated in the ELI-002 7P arm, potentially suppressing the ITT treatment effect. HR 1.56 1 1 Multivariate Cox model for DFS-adjusted HR (ITT)| Elicio Therapeutics
Stronger Treatment Effect Observed in Lower Residual Disease Patient Population 1 8 Post-hoc analyses demonstrate stronger treatment effect in lower residual disease ITT HR = 0.79 P = 0.2492, N = 144 R0 Resected HR = 0.65 P = 0.0484, N = 121 The analyses show the potential for improved treatment effect in lower residual disease, R0 resected population. ELI-002 7P (n=96) SOC (n=48) ELI-002 7P (n=78) SOC (n=43) SOCELI-002 7P 21.223.8Median (mo) 0.79 (0.48-1.28)HR P 0.2492Wilcoxon SOCELI-002 7P 12.823.8Median (mo) 0.65 (0.38-1.12)HR P 0.0484Wilcoxon 1 Unstratified analyses, Wilcoxon Primary DFS analyses used specified stratified Logrank test; ITT HR 0.85.| Elicio Therapeutics
mKRAS-Specific T Cell Responses Were Strongly Associated with Improved DFS 9 Greater mKRAS-specific T cell responses were associated with longer DFS following ELI-002 7P treatment 0 3 6 9 12 15 18 21 24 27 30 0 25 50 75 100 Months from randomization D FS P ro ba bi lit y ELI-002 7P DFS: ITT Supervised by mKRAS- specific T cell Response 2 20-APR-2026DCO NR>9.17xMedian DFS (Months) 6.08<9.17x 0.22 HR (95% CI) (0.08 – 0.63) <0.0001P-value Ph1-defined 9.17x Threshold 1mKRAS T cell fold- change from baseline: >9.17x (n=74) <9.17x (n=16) 1 Wainberg, O’Reilly, et al. Nature Medicine. 2025; 2 mKRAS T cell fold-change assessed among n=90 evaluable patients Immune response to ELI-002 7P was observed to be a strong predictor of DFS benefit. | Elicio Therapeutics
ELI-002 7P Demonstrated a Favorable Safety and Tolerability Profile 10 Safety profile supports extended treatment and combination strategies Proportionally Fewer Adverse Events Observed vs. SOC • Proportionally fewer ELI-002 7P patients had adverse events (AEs), Grade ≥3 AEs, and Serious AEs • 5% had ELI-002 7P dose delays • 0% stopped ELI-002 7P for toxicity • 0% treatment-related deaths • AE event terms were similar across groups (e.g. diarrhea, fatigue in both arms reflected prior Whipple surgery) SOC n (%) ELI-002 7P n (%) Category 37 (77.1)70 (72.9)Any TEAE 0 (0.0)23 (24.0)Treatment-related TEAE 7 (14.6)10 (10.4)Grade ≥ 3 TEAE 4 (8.3)6 (6.3)Serious TEAE 0 (0.0)5 (5.2)TEAE leading to dose modification 0 (0.0)0 (0.0)TEAE leading to withdrawal 0 (0.0)0 (0.0)TEAE leading to death TEAE: Treatment emergent adverse event| Elicio Therapeutics
A Precision Medicine Roadmap to Adjuvant PDAC Pivotal Phase 3 11 Key Phase 2 findings inform the Phase 3 development strategy Robust early efficacy during the dosing period with DFS separation maintained through 9 months Strong efficacy signal in completely resected R0 patients consistent with lower residual disease Extend ELI-002 7P Treatment Duration Target R0 Patients Phase 2 findings support a precision medicine Phase 3 strategy focused on R0 resected patients and additional dosing. Note: MRD positivity was defined as either ctDNA positivity or elevated/rising CA19-9; therefore, exclusion of ctDNA-positive patients does not equate to exclusion of all MRD-positive patients| Elicio Therapeutics
Phase 2: R0 ~84% (121/144) A Substantial Post-Surgical Treatment Gap Remains in Adjuvant PDAC Observation remains standard of care despite substantial recurrence risk after surgery and chemotherapy 12 1 Leonhardt CS, et al. Gastroenterology. 2024, 2 Kleeff J, et al. Ann. Surgery. 2007, 3 Daamen LA, et al. Trials. 2024 4 NCCN Clinical Practive Guidelines in Oncology: Pancreatic Adenocarcinoma (latest version), 5. SEER Cancer Statistics Review (Pancreatic Cancer) ELI-002 7P is designed to delay recurrence or prevent progression or death after standard locoregional therapy Current treatment course leaves a major post-surgical recurrence gap Neoadjuvant chemo Surgery R0/R1 resection Peri-operative / adjuvant chemo Observation until recurrence >50% Recurrence within 12-months 1 ~70-80% Recurrence within 24-months 2,3 0 Approved immunotherapies for adjuvant PDAC 4 13% 5-year overall survival all stages 5 No approved treatment following locoregional therapy | Elicio Therapeutics
Selection of R0 Resected Patients Offers a Clear Phase 3 Development Strategy 13 R0 resected disease setting selects for lower disease burden and slower recurrence kinetics R1 ResectionR0 ResectionFeature Microscopic tumor presentMicroscopic tumor not presentSurgical Margin Status ↑ Higher↓ LowestResidual Disease Burden Micro-metastatic disease + local residual tumorOccult micro-metastatic diseaseSource of Recurrence ↑ Higher↓ LowerBaseline Recurrence Risk Typically, shorterTypically, longerExpected Time to Recurrence R1 patients represent a distinct higher-burden disease setting outside the target population Population most likely to benefit from adjuvant ELI-002 7PImplication for ELI-002 7P Development Excluded from Phase 3Phase 3 enrollment in focused R0 population | Elicio Therapeutics
Biology of R1 Resected PDAC is Distinct from R0 Resected 14 R1 margins found in ~20% of PDAC resections indicate unique biology of disease underlying increased recurrence risk 1 Hernandez, et al. Annals Surg. 2009; 2Tummers, et al. Br J Surg. 2019; 3 Esposito, et al. Annals Surg Oncol. 2008 17 patients underwent extended surgery to convert R1 → R0 margins during the operation. Median OS was 11 months for R1 → R0, and 13 months in R1 without extra surgery, indicating that tumor biology beyond the presence of cancer cells at the margin is responsible. Repeat resection to achieve R0 does not improve outcome 1 R1 tumors associate with more rapid recurrence R1 tumors spread along blood/lymph vessels and nervesR1 Resected R0 Resected 3 Overall Recurrence2 | Elicio Therapeutics
Next Steps 15 01 02 Engage with FDA: End-of-Phase 2 Meeting Align with FDA on Phase 3 design & regulatory strategy: ELI-002 7P in R0 resected adjuvant mKRAS PDAC Initiate Phase 3 Study in Adjuvant PDAC Post FDA alignment, initiate Phase 3, subject to funding Phase 2 results support continued regulatory, clinical and operational advancement of ELI-002 7P 03 Broaden Pipeline Across Multiple Indications PDAC provides a clinical foundation for evaluating AMP-enabled immunotherapies across multiple oncogenic targets, subject to funding | Elicio Therapeutics
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FAQ
What did Elicio Therapeutics (ELTX) report from the Phase 2 AMPLIFY-7P trial?
Elicio reported that the randomized Phase 2 AMPLIFY-7P trial in adjuvant mKRAS-driven pancreatic cancer did not meet its primary DFS endpoint. However, early landmark analyses showed about a 14% absolute disease-free survival benefit during active ELI-002 7P treatment.
How did ELI-002 7P perform in R0 resected pancreatic cancer patients in AMPLIFY-7P?
In completely resected R0 patients, ELI-002 7P showed a disease-free survival hazard ratio of 0.65 and median DFS of 23.8 months versus 12.8 months with observation. These post-hoc findings in roughly 84% of participants guide the planned Phase 3 focus.
What safety profile did ELI-002 7P show in the AMPLIFY-7P study for ELTX?
ELI-002 7P demonstrated a favorable safety and tolerability profile, with no treatment-related discontinuations or treatment-related deaths. Proportionally fewer patients experienced adverse events, serious adverse events, or Grade 3 or higher events compared with standard-of-care observation.
How do mKRAS-specific T cell responses relate to outcomes in Elicio’s AMPLIFY-7P trial?
mKRAS-specific T cell responses strongly correlated with improved disease-free survival, with a hazard ratio of 0.22 in evaluable patients. Those showing greater T cell fold-change from baseline experienced the most favorable outcomes, supporting the biological activity of ELI-002 7P.
What Phase 3 development strategy did Elicio (ELTX) outline for ELI-002 7P?
Elicio plans a registrational Phase 3 trial in adjuvant mKRAS pancreatic cancer focused on R0 resected patients after locoregional therapy. The design includes additional dosing beyond initial immunizations and a primary endpoint of disease-free survival, subject to regulatory discussions and funding.
What is Elicio Therapeutics’ cash runway following the AMPLIFY-7P update?
The company expects its current cash and cash equivalents to support planned operations into the fourth quarter of 2026. Elicio is also evaluating strategic financing and partnership opportunities to advance the planned Phase 3 program and its broader AMP immunotherapy platform.
How many patients were enrolled in the AMPLIFY-7P trial of ELI-002 7P?
The AMPLIFY-7P trial enrolled 144 patients with resected Stage I–III mKRAS-driven pancreatic ductal adenocarcinoma across 24 U.S. sites. Patients had completed surgery and standard locoregional therapy and were radiographically free of disease at enrollment before randomization.