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Elicio TherapeuticsF
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Related articleQuarter not tagged2026-10-23

Elicio Therapeutics Presents Late-Breaking Phase 2 AMPLIFY-7P Results at ESMO Congress 2026 and Announces Simultaneous Publication in Nature Medicine

GlobeNewswire
- Multiple pre-specified subgroup analyses favored camupepimut (ELI-002 7P), including patients with and without detectable baseline ctDNA. - Encouraging disease-free survival outcomes were observed in both ctDNA-negative (HR 0.51) and ctDNA-positive (HR 0.57) patients. - Baseline prognostic imbalances provide important context for the intent-to-treat results, including a 53% lower risk of recurrence or death with camupepimut (multivariable adjusted HR 0.47; p=0.0086). - Integrated clinical and translational findings provide clear direction for refining patient stratification, optimizing dosing and advancing Phase 3 development. BOSTON, Oct. 23, 2026 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX) ("Elicio" or the "Company"), a clinical-stage biotechnology company developing next-generation immunotherapies for KRAS-driven cancers, today announced results from the randomized Phase 2 AMPLIFY-7P study of camupepimut (ELI-002 7P), presented in a late-breaking Proffered Paper oral session at the European Society for Medical Oncology ("ESMO") Congress 2026 in Madrid, Spain, and simultaneously published in Nature Medicine: "Lymph node-targeted, mKRAS-specific amphiphile vaccine in pancreatic cancer: the randomized phase 2 AMPLIFY-7P trial". Across multiple pre-specified analyses, camupepimut demonstrated consistent and favorable treatment-effect trends in patients with and without detectable baseline ctDNA and in patients without prior radiation. While the study did not meet its pre-specified primary disease-free survival ("DFS") endpoint in the intent-to-treat ("ITT") population (HR 0.85), the results should be considered in the context of a baseline imbalance in ctDNA positivity, a strong predictor of recurrence, which was more prevalent in the camupepimut arm (20.8% vs. 12.5%). Translational analyses also demonstrated broad, persistent mutant KRAS-specific T-cell responses associated with longer DFS. Together, these findings inform a refined Phase 3 development strategy. "The AMPLIFY-7P results provide important new insights into camupepimut's clinical activity and reinforce our confidence in its potential for patients with pancreatic cancer," said Robert Connelly, President and Chief Executive Officer of Elicio. "We are encouraged by the consistent treatment-effect trends across pre-specified patient groups, including patients with and without dete…Read full document

- Multiple pre-specified subgroup analyses favored camupepimut (ELI-002 7P), including patients with and without detectable baseline ctDNA. - Encouraging disease-free survival outcomes were observed in both ctDNA-negative (HR 0.51) and ctDNA-positive (HR 0.57) patients. - Baseline prognostic imbalances provide important context for the intent-to-treat results, including a 53% lower risk of recurrence or death with camupepimut (multivariable adjusted HR 0.47; p=0.0086). - Integrated clinical and translational findings provide clear direction for refining patient stratification, optimizing dosing and advancing Phase 3 development. BOSTON, Oct. 23, 2026 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX) ("Elicio" or the "Company"), a clinical-stage biotechnology company developing next-generation immunotherapies for KRAS-driven cancers, today announced results from the randomized Phase 2 AMPLIFY-7P study of camupepimut (ELI-002 7P), presented in a late-breaking Proffered Paper oral session at the European Society for Medical Oncology ("ESMO") Congress 2026 in Madrid, Spain, and simultaneously published in Nature Medicine: "Lymph node-targeted, mKRAS-specific amphiphile vaccine in pancreatic cancer: the randomized phase 2 AMPLIFY-7P trial". Across multiple pre-specified analyses, camupepimut demonstrated consistent and favorable treatment-effect trends in patients with and without detectable baseline ctDNA and in patients without prior radiation. While the study did not meet its pre-specified primary disease-free survival ("DFS") endpoint in the intent-to-treat ("ITT") population (HR 0.85), the results should be considered in the context of a baseline imbalance in ctDNA positivity, a strong predictor of recurrence, which was more prevalent in the camupepimut arm (20.8% vs. 12.5%). Translational analyses also demonstrated broad, persistent mutant KRAS-specific T-cell responses associated with longer DFS. Together, these findings inform a refined Phase 3 development strategy. "The AMPLIFY-7P results provide important new insights into camupepimut's clinical activity and reinforce our confidence in its potential for patients with pancreatic cancer," said Robert Connelly, President and Chief Executive Officer of Elicio. "We are encouraged by the consistent treatment-effect trends across pre-specified patient groups, including patients with and without detectable baseline ctDNA, and by the strong mKRAS-specific immune responses associated with clinical outcomes. These insights give us clear direction for our potential Phase 3 strategy." Pre-Specified Analyses Show Consistent Treatment-Effect Direction Across Baseline ctDNA Subgroups - In the 93 patients with baseline ctDNA-negative status, median DFS was not reached in the camupepimut arm vs. 21.2 months in the observation arm (HR 0.51; nominal p=0.0280). Recurrence or death was observed in 27.4% (17/62) of camupepimut-treated patients vs. 48.4% (15/31) of patients in observation. - A consistent treatment effect was also observed in the smaller, higher-risk baseline ctDNA-positive subgroup (n=26). Median DFS was 4.3 months with camupepimut vs. 1.9 months with observation (HR 0.57; nominal p=0.0489). - Prior radiation predicted lower baseline lymphocyte counts and reduced camupepimut-induced mKRAS T cell responses. In pre-specified analysis, patients who had not received prior radiation (n=106) had median DFS of 23.8 months with camupepimut vs. 10.4 months with observation (HR 0.59; nominal p=0.0221). Pre-specified Subgroup | Arm | N | Median DFS | HR, p-value ctDNA negative | Camupepimut | 62 | Not Reached | HR 0.51 Observation | 31 | 21.2 Months | P=0.0280 ctDNA positive | Camupepimut | 20 | 4.3 Months | HR 0.57 Observation | 6 | 1.9 Months | P=0.0489 No Prior Radiation | Camupepimut | 73 | 23.8 Months | HR 0.59 Observation | 33 | 10.4 Months | P=0.0221 Baseline Prognostic Imbalance Provides Important Context for ITT Results - Baseline ctDNA status emerged as a particularly strong prognostic marker. In a pooled analysis across treatment groups, median DFS was 4.2 months for ctDNA-positive patients versus 24.0 months for ctDNA-negative patients (HR 6.56; nominal p<0.000001). Patients with baseline ctDNA positivity were more prevalent in the camupepimut arm (20.8%; 20/96) than in the observation arm (12.5%; 6/48). - A multivariable model adjusting for baseline factors estimated an association between camupepimut treatment and lower recurrence risk (adjusted HR 0.47; p=0.0086), while elevated CA19-9 (adjusted HR 3.16; p<0.0001) and positive baseline ctDNA (adjusted HR 5.99; p<0.0001) were associated with higher risk. Early DFS Separation and Immune Findings Support Further Evaluation - Six-month DFS was 75.7% with camupepimut vs. 61.7% with observation, a 14.0 percentage-point difference immediately following the treatment period supports evaluating treatment duration in future studies. - Camupepimut induced mutant KRAS-specific T-cell responses in 99% of evaluable treated patients (median 44.3-fold increase from baseline. Among patients evaluated for T-cell subsets, 85% generated both CD4 and CD8 responses. Responses persisted at least 46 weeks from baseline in 95.5% of evaluable treated patients; 13 of 15 patients in a selected subset showed responses to additional tumor targets. - In an exploratory analysis, stronger camupepimut-induced mutant KRAS-specific T-cell responses were associated with significantly longer DFS. Median DFS was not reached among patients with immune responses above a previously identified threshold (82%, 74/90) vs. 6.08 months among those below the threshold (HR 0.22; nominal p<0.0001). Generally Well-Tolerated Safety Profile - Camupepimut was generally well tolerated, with no new safety signals observed. Grade 3 or higher adverse events occurred in 10.4% of patients receiving camupepimut vs. 14.6% under observation; serious adverse events occurred in 6.3% and 8.3%, respectively. No adverse events led to withdrawal of study medication. "The Phase 2 translational findings build on and reinforce our Phase 1 observations, demonstrating that camupepimut generates broad and persistent mutant KRAS-specific T-cell responses, with stronger immune responses associated with longer DFS," said Christopher Haqq, M.D., Ph.D., Executive Vice President, Head of Research and Development and Chief Medical Officer of Elicio. "These observations across both baseline ctDNA subgroups and camupepimut's favorable safety and tolerability profile provide a strong scientific and clinical rationale for a refined Phase 3 design incorporating optimized patient stratification, extended treatment duration and potential combination approaches." Implications for Further Development Elicio plans to discuss the totality of AMPLIFY-7P findings with the U.S. Food and Drug Administration to inform a potential Phase 3 study in adjuvant pancreatic cancer. Areas for consideration include baseline ctDNA and other prognostic factors in stratification and patient selection, treatment duration, and combination strategies intended to deepen or sustain mutant KRAS-specific immune activity. Any future study design remains subject to regulatory discussion and further development planning. About the AMPLIFY-7P Phase 2 Study AMPLIFY-7P Phase 2 is a randomized study evaluating camupepimut versus observation in patients with mutant KRAS-driven pancreatic ductal adenocarcinoma following completion of standard locoregional therapy. The study enrolled 144 patients across 24 U.S. clinical sites. About ELI-002 Elicio's lead product candidate, ELI-002, is a structurally novel investigational Amphiphile ("AMP") cancer immunotherapy that targets cancers driven by mutations in the KRAS gene, a prevalent driver of many human cancers. ELI-002 is comprised of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant, and is available as an off-the-shelf subcutaneous administration. Camupepimut (ELI-002 7P), the seven-peptide formulation, was evaluated in the randomized Phase 2 AMPLIFY-7P trial in patients with mKRAS-driven pancreatic cancer. The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations present across multiple solid tumors. About Elicio Therapeutics Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company advancing next-generation immunotherapies for the treatment of KRAS-driven 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 neoadjuvant settings and for prophylaxis in high-risk patients, contrary to personalized immunotherapy approaches. Elicio's pipeline includes additional off-the-shelf therapeutic cancer immunotherapy candidates, including ELI-007 and ELI-008, which target BRAF-driven cancers and p53 hotspot mutations, respectively. For more information, please visit www.elicio.com. Elicio 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 timing and content of Elicio's presentation at ESMO Congress 2026; the clinical activity, therapeutic potential and potential benefits of camupepimut (ELI-002 7P); the interpretation and potential implications of results and analyses from the AMPLIFY-7P study; the potential for new pre-specified analyses to further characterize the clinical activity of camupepimut (ELI-002 7P); the potential for such analyses and the totality of AMPLIFY-7P findings to inform or support a refined Phase 3 development strategy; 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 forward-looking statements 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 camupepimut; the timing of the availability and presentation of data from Elicio's clinical trials; Elicio's plans to research, develop and commercialize its current and future product candidates; the design and timing of future clinical trials; 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 amended on April 29, 2026, Elicio's Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 11, 2026, and Elicio's Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the SEC on August 13, 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. Elicio Investor Relations Contact Brian Ritchie LifeSci Advisors (212) 915-2578 [email protected]

Related articleQuarter not tagged2026-08-13

Elicio Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Updates

GlobeNewswire
Following the observation of multiple complete responses, Elicio plans to initiate a Phase 1 combination study of ELI-002 7P plus a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor in metastatic pancreatic cancer; Phase 1 study anticipated to initiate Q4 2026 While Phase 2 AMPLIFY-7P trial did not meet its primary endpoint, Elicio continues to evaluate pre-specified subgroups, including the R0 resected population, to further refine its Phase 3 development strategy for ELI-002 7P in adjuvant pancreatic ductal adenocarcinoma (“PDAC”) Memorial Sloan Kettering Cancer Center-led Phase 1 trial activated evaluating ELI-002 7P plus chemotherapy and checkpoint inhibition with treatment initiating in neoadjuvant pancreatic cancer and continuing post-resection $15 million financing in July 2026, strengthens balance sheet to support cash runway into Q1 2027 BOSTON, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or the “Company”), a clinical-stage biotechnology company developing a pipeline of next-generation immunotherapies for KRAS-driven cancers, today reported financial results for the quarter ended June 30, 2026, and provided recent corporate and clinical updates. “The encouraging clinical observations reported to date, including multiple complete responses following ELI-002 7P treatment and subsequent checkpoint inhibition, further support the promise of our AMP platform approach and its potential to generate durable anti-tumor immune responses,” said Robert Connelly, Chief Executive Officer of Elicio. “Our recent financing provided us with the capital needed to evaluate initial data from our planned Phase 1 combination study of ELI-002 7P with a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor, which is anticipated to begin in the fourth quarter of this year. We are excited to advance our combination strategy and hope to unlock the full potential of our AMP platform to deliver durable clinical benefit for patients with metastatic pancreatic cancer.” Recent Highlights Reported multiple complete responses following ELI-002 7P treatment and subsequent checkpoint inhibition in metastatic mKRAS pancreatic cancer, which Elicio believes supports the planned Phase 1 combination study. Reported results from the Phase 2 AMPLIFY-7P trial for ELI-002 7P in adjuvant mKRAS-driven pancreatic cancer follow…Read full document

Following the observation of multiple complete responses, Elicio plans to initiate a Phase 1 combination study of ELI-002 7P plus a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor in metastatic pancreatic cancer; Phase 1 study anticipated to initiate Q4 2026 While Phase 2 AMPLIFY-7P trial did not meet its primary endpoint, Elicio continues to evaluate pre-specified subgroups, including the R0 resected population, to further refine its Phase 3 development strategy for ELI-002 7P in adjuvant pancreatic ductal adenocarcinoma (“PDAC”) Memorial Sloan Kettering Cancer Center-led Phase 1 trial activated evaluating ELI-002 7P plus chemotherapy and checkpoint inhibition with treatment initiating in neoadjuvant pancreatic cancer and continuing post-resection $15 million financing in July 2026, strengthens balance sheet to support cash runway into Q1 2027 BOSTON, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or the “Company”), a clinical-stage biotechnology company developing a pipeline of next-generation immunotherapies for KRAS-driven cancers, today reported financial results for the quarter ended June 30, 2026, and provided recent corporate and clinical updates. “The encouraging clinical observations reported to date, including multiple complete responses following ELI-002 7P treatment and subsequent checkpoint inhibition, further support the promise of our AMP platform approach and its potential to generate durable anti-tumor immune responses,” said Robert Connelly, Chief Executive Officer of Elicio. “Our recent financing provided us with the capital needed to evaluate initial data from our planned Phase 1 combination study of ELI-002 7P with a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor, which is anticipated to begin in the fourth quarter of this year. We are excited to advance our combination strategy and hope to unlock the full potential of our AMP platform to deliver durable clinical benefit for patients with metastatic pancreatic cancer.” Recent Highlights Reported multiple complete responses following ELI-002 7P treatment and subsequent checkpoint inhibition in metastatic mKRAS pancreatic cancer, which Elicio believes supports the planned Phase 1 combination study. Reported results from the Phase 2 AMPLIFY-7P trial for ELI-002 7P in adjuvant mKRAS-driven pancreatic cancer following completion of standard locoregional therapy. The trial did not meet the primary endpoint but Elicio continues to evaluate pre-specified subgroups, including the R0 resected population, to further refine its Phase 3 development strategy for ELI-002 7P in adjuvant PDAC. Announced the activation of an investigator-initiated Phase 1 neoadjuvant trial evaluating ELI-002 7P plus chemotherapy and an anti-PD-1 checkpoint inhibitor in borderline resectable and resectable pancreatic ductal adenocarcinoma (“PDAC”). The multi-center study is being led by Memorial Sloan Kettering Cancer Center and funded through a strategic partnership between The Lustgarten Foundation and Break Through Cancer. Published a peer-reviewed manuscript in Science Advances highlighting the potent and durable immune responses generated by certain amphiphile (“AMP”)-DNA adjuvant candidates developed using the Company's lymph node-targeting AMP platform technology. Completed a $15.0 million registered direct offering led by new institutional investors to support the planned Phase 1 development of ELI-002 7P in metastatic pancreatic cancer and advance the Company's pipeline. Added to the Russell 2000® and Russell 3000® Indexes, broadening visibility among institutional investors and index-based funds. Upcoming Anticipated Milestones Initiation of the Phase 1 combination trial for ELI-002 7P in combination with a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor in metastatic mKRAS pancreatic cancer anticipated in Q4 2026 Second Quarter 2026 Financial Results R&D expense for the second quarter of 2026 was $6.8 million, compared to $7.0 million for the second quarter of 2025. The decrease of $0.2 million was primarily due to lower clinical trial costs as the Phase 2 study of ELI-002 7P continued and the patients moved out of the active dosing phase and into the follow up phase of the trial. G&A expense for the second quarter of 2026 was $3.6 million, compared to $3.1 million for the second quarter of 2025. The increase of $0.5 million was primarily due to increased Company headcount resulting in increased personnel costs and a slight increase in professional fees. Net loss for the second quarter of 2026 was $8.2 million, compared to $10.6 million for the second quarter of 2025. Net loss per share for the second quarter of 2026 was $0.43 compared to $0.66 for the second quarter of 2025. Cash and cash equivalents were $23.5 million as of June 30, 2026. The Company raised net proceeds of $16.6 million in the second quarter of 2026, for aggregate net proceeds of approximately $24.4 million year to date, through its established at-the-market program. In July 2026, the Company raised aggregate gross proceeds of approximately $15.0 million in a registered direct offering before deducting the placement agents’ fees and related offering expenses. The Company expects that its current cash and cash equivalents will support operations into the first quarter of 2027. Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company advancing next-generation immunotherapies for the treatment of KRAS-driven 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. 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. 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. Elicio continues to evaluate pre-specified subgroups, including the R0 resected population, and intends to further refine its Phase 3 development strategy for ELI-002 7P in adjuvant PDAC. Elicio intends to initiate a Phase 1 study in metastatic PDAC designed to provide a rapid assessment of clinical activity using an open label design to assess the objective response rate including partial and complete radiographic responses. Elicio plans to use the study findings to further evaluate checkpoint inhibitor combinations and help inform future development strategies in metastatic PDAC and the adjuvant PDAC Phase 3 trial. At the time of the Phase 2 AMPLIFY-7P analysis, data for overall survival remained immature. ELI-002 also has been studied in patients with mKRAS-positive colorectal cancer in Phase 1 studies. In the future, Elicio may seek to expand ELI-002 7P to other indications, including mKRAS-positive lung cancer and other mKRAS-positive cancers, subject to financing. 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 Amphiphile Platform Elicio’s proprietary AMP platform delivers investigational immunotherapeutics 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 immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the local injection site, as it travels to lymphatic tissue. 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 Q1 2027; Elicio’s planned clinical programs, including the timing and outcome of planned clinical trials, including the 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 PDAC; the potential validation of the combination in a Phase 1 study; the potential of Elicio’s product candidates, including the potential of ELI-002 7P; the potential for the Phase 1 study to provide a rapid development pathway for ELI-002 7P; the potential for the Phase 1 study to inform Elicio’s Phase 3 design in adjuvant PDAC; 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 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, 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 amended on April 29, 2026, and Elicio’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 11, 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 ContactBrian RitchieLifeSci Advisors(212) [email protected]

Related articleQuarter not tagged2026-08-13

Elicio Therapeutics: Q2 Earnings Snapshot

Associated Press

BOSTON (AP) — BOSTON (AP) — Elicio Therapeutics, Inc. (ELTX) on Thursday reported a loss of $8.2 million in its second quarter. On a per-share basis, the Boston-based company said it had a loss of 43 cents. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on ELTX at https://www.zacks.com/ap/ELTX

Related articleQuarter not tagged2026-05-12

Elicio Therapeutics: Q1 Earnings Snapshot

Associated Press

BOSTON (AP) — BOSTON (AP) — Elicio Therapeutics, Inc. (ELTX) on Monday reported a loss of $11.8 million in its first quarter. On a per-share basis, the Boston-based company said it had a loss of 65 cents. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on ELTX at https://www.zacks.com/ap/ELTX

Related articleQuarter not tagged2026-05-12

Elicio Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Updates

GlobeNewswire
In the ongoing Phase 2 AMPLIFY-7P study evaluating ELI-002 7P in patients with pancreatic ductal adenocarcinoma (“PDAC”), the event-driven primary disease-free survival (“DFS”) analysis is anticipated mid-year 2026 The Company raised net proceeds of approximately $8.0 million in Q1 2026 and an additional $5.0 million in Q2 2026 to date, for aggregate net proceeds of approximately $13.0 million, through its established at-the-market program Projected cash runway beyond the expected AMPLIFY-7P Phase 2 final DFS data BOSTON, May 11, 2026 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or the “Company”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today reported financial results for the quarter ended March 31, 2026, and provided recent corporate and clinical updates. “We remain focused on advancing the Phase 2 AMPLIFY-7P trial and anticipate reaching the event-driven primary DFS analysis of ELI-002 7P in post-resection KRAS-driven PDAC mid-year 2026,” said Robert Connelly, Chief Executive Officer of Elicio. “We are encouraged by the durability of T-cell responses and clinical observations to date, supporting the potential of ELI-002 7P to favorably impact outcomes as monotherapy in the adjuvant PDAC setting. With our cash runway now expected to extend into Q4 2026, beyond the anticipated DFS readout, we believe we are well positioned to execute on this key milestone and further advance our amphiphile (“AMP”) platform in KRAS-mutant pancreatic cancer and other indications, with the goal of delivering meaningful long-term value for patients and shareholders.” Updates on the AMPLIFY-7P Phase 2 Trial The event-driven primary DFS endpoint analysis for Elicio’s randomized Phase 2 AMPLIFY-7P trial in post-resection mKRAS PDAC is anticipated mid-year 2026 Fewer disease progressions and deaths than projected to date have been observed in the ongoing 2:1 randomized Phase 2 AMPLIFY-7P trial The Company remains blinded to the Phase 2 AMPLIFY-7P trial clinical efficacy outcomes Following completion of the primary DFS endpoint analysis, the Company plans to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”) to align on the Phase 3 trial design for ELI-002 7P in resected mKRAS PDAC and to advance ELI-002 7P toward initiation of a registrational study…Read full document

In the ongoing Phase 2 AMPLIFY-7P study evaluating ELI-002 7P in patients with pancreatic ductal adenocarcinoma (“PDAC”), the event-driven primary disease-free survival (“DFS”) analysis is anticipated mid-year 2026 The Company raised net proceeds of approximately $8.0 million in Q1 2026 and an additional $5.0 million in Q2 2026 to date, for aggregate net proceeds of approximately $13.0 million, through its established at-the-market program Projected cash runway beyond the expected AMPLIFY-7P Phase 2 final DFS data BOSTON, May 11, 2026 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or the “Company”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today reported financial results for the quarter ended March 31, 2026, and provided recent corporate and clinical updates. “We remain focused on advancing the Phase 2 AMPLIFY-7P trial and anticipate reaching the event-driven primary DFS analysis of ELI-002 7P in post-resection KRAS-driven PDAC mid-year 2026,” said Robert Connelly, Chief Executive Officer of Elicio. “We are encouraged by the durability of T-cell responses and clinical observations to date, supporting the potential of ELI-002 7P to favorably impact outcomes as monotherapy in the adjuvant PDAC setting. With our cash runway now expected to extend into Q4 2026, beyond the anticipated DFS readout, we believe we are well positioned to execute on this key milestone and further advance our amphiphile (“AMP”) platform in KRAS-mutant pancreatic cancer and other indications, with the goal of delivering meaningful long-term value for patients and shareholders.” Updates on the AMPLIFY-7P Phase 2 Trial The event-driven primary DFS endpoint analysis for Elicio’s randomized Phase 2 AMPLIFY-7P trial in post-resection mKRAS PDAC is anticipated mid-year 2026 Fewer disease progressions and deaths than projected to date have been observed in the ongoing 2:1 randomized Phase 2 AMPLIFY-7P trial The Company remains blinded to the Phase 2 AMPLIFY-7P trial clinical efficacy outcomes Following completion of the primary DFS endpoint analysis, the Company plans to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”) to align on the Phase 3 trial design for ELI-002 7P in resected mKRAS PDAC and to advance ELI-002 7P toward initiation of a registrational study First Quarter 2026 Financial Results R&D expenses were $6.8 million for the three months ended March 31, 2026, compared to $7.8 million for the three months ended March 31, 2025. The decrease in R&D expenses was primarily due to lower clinical trial costs as the Phase 2 study of ELI-002 7P continues and the patients moved out of the active dosing phase and into the follow up phase of the trial. G&A expenses were $3.8 million for the three months ended March 31, 2026, compared to $3.0 million for the three months ended March 31, 2025. The increase in G&A expenses was primarily due to increased Company headcount resulting in increased personnel costs and a slight increase in professional fees. Net loss was $11.8 million for the three months ended March 31, 2026, compared to $11.2 million for the three months ended March 31, 2025. Net loss for the three months ended March 31, 2026 includes $1.0 million of non-cash other expense primarily resulting from the change in fair value of the warrant liability. Net loss per share for the three months ended March 31, 2026 was $0.65, compared to $0.87 for the three months ended March 31, 2025. Cash and cash equivalents were $14.9 million as of March 31, 2026, compared to $18.6 million as of December 31, 2025. The Company raised net proceeds of $8.0 million in Q1 2026 and an additional $5.0 million in Q2 2026 to date, for aggregate net proceeds of approximately $13.0 million, through its established at-the-market program. The Company expects its current cash and cash equivalents to support planned operations into Q4 2026, beyond the anticipated AMPLIFY-7P Phase 2 event-driven DFS analysis expected mid-year 2026. 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 successes 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. Elicio intends to expand ELI-002 7P clinical development not only for treatment in adjuvant PDAC, but also in neo-adjuvant and metastatic PDAC settings, and for other mKRAS-positive cancers. 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 is being studied in an ongoing, randomized clinical trial in patients with mKRAS-positive PDAC who completed standard therapy but remain at high risk of relapse. ELI-002 also has been studied in patients with mKRAS-positive colorectal cancer (“CRC”) in Phase 1 studies. The updated AMPLIFY-201 Phase 1 data for PDAC and CRC was presented at the ESMO Immuno-Oncology Congress 2024 and included a 16.3-month median recurrence-free survival and 28.9-month median overall survival for the full study population. 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. 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 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 2P (2-peptide formulation) has been studied in the Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy (NCT04853017). ELI-002 7P (7-peptide formulation) is currently being studied in a Phase 1/2 (AMPLIFY-7P) trial in patients with mKRAS-driven pancreatic cancer (NCT05726864). 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 Amphiphile Platform Elicio’s proprietary AMP platform delivers investigational immunotherapeutics 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 preclinical 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 immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the local injection site, as it travels to lymphatic tissue. 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, beyond the anticipated AMPLIFY-7P Phase 2 event-driven primary DFS endpoint analysis anticipated mid-year 2026; Elicio’s planned clinical programs, including the timing and outcome of planned clinical trials; the timing of the expected event-driven primary DFS endpoint analysis of the Phase 2 AMPLIFY-7P trial anticipated mid-year 2026; the potential efficacy of Elicio’s product candidates, including ELI-002 7P; the potential of Elicio’s product candidates, including ELI-002 7P, to favorably impact outcomes as monotherapy in the adjuvant PDAC setting; Elicio’s plan to request an End of Phase 2 meeting with the FDA to align on the Phase 3 trial design for ELI-002 7P and the potential outcome of such meeting, if granted; Elicio’s plans to advance ELI-002 7P toward initiation of a registrational study; the potential for future expansion of ELI-002 to other indications including, in neo-adjuvant and metastatic PDAC settings, 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 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, Elicio’s financial condition, including its anticipated cash runway, and ability to obtain the funding necessary to advance the development of ELI-002 7P and any other future product candidates, and Elicio’s ability to continue as a going concern; 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, including the event-driven primary DFS endpoint analysis from the Phase 2 AMPLIFY-7P trial anticipated mid-year 2026; 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 [email protected]

Related articleQuarter not tagged2026-03-13

Elicio Therapeutics Reports Full Year 2025 Financial Results and Provides Corporate Updates

GlobeNewswire
Event-driven primary disease-free survival (“DFS”) analysis for Phase 2 AMPLIFY-7P study evaluating ELI-002 7P in patients with pancreatic ductal adenocarcinoma (“PDAC”) is anticipated in 1H 2026 Fewer disease progressions and deaths than projected to date have been observed in the ongoing 2:1 randomized Phase 2 AMPLIFY-7P trial The Company remains blinded to the Phase 2 AMPLIFY-7P trial clinical efficacy outcomes. Projected cash runway into Q3 2026, beyond the anticipated AMPLIFY-7P Phase 2 DFS analysis in 1H 2026 BOSTON, March 12, 2026 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or the “Company”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today reported financial results for the year ended December 31, 2025, and provided recent corporate and clinical updates. “In 2025, we made meaningful progress advancing ELI-002 7P in KRAS-mutant pancreatic cancer,” said Robert Connelly, Chief Executive Officer of Elicio. “We remain focused on completing the Phase 2 AMPLIFY-7P trial and reaching the event-driven primary DFS analysis expected in 1H 2026. We are encouraged by the continued observation of fewer disease progressions and deaths to date than projected in the 2:1 randomized trial, as well as by the durability of T-cell responses and clinical observations reported to date, which reinforce our confidence in ELI-002 7P’s potential to favorably impact outcomes. With capital expected to carry us beyond the anticipated DFS readout, we believe we are well positioned to deliver this important milestone and continue advancing our Amphiphile (“AMP”) platform in KRAS-mutant PDAC. We remain highly interested in the potential to expand the development of ELI-002 7P to neoadjuvant and metastatic PDAC and other KRAS+ tumors, with the goal of creating meaningful long-term value for patients and shareholders.” Recent Highlights In 2025, Elicio continued advancement of the randomized Phase 2 AMPLIFY-7P trial in post-resection mKRAS PDAC, with the event-driven primary DFS analysis remaining on track for an anticipated 1H 2026 readout In December 2025, Elicio reported evidence of antigen spreading to patient-specific neoantigens beyond mKRAS in the ongoing Phase 2 AMPLIFY-7P trial, demonstrating induction of de novo T cell responses against non-vaccine tumor neoantigens and further s…Read full document

Event-driven primary disease-free survival (“DFS”) analysis for Phase 2 AMPLIFY-7P study evaluating ELI-002 7P in patients with pancreatic ductal adenocarcinoma (“PDAC”) is anticipated in 1H 2026 Fewer disease progressions and deaths than projected to date have been observed in the ongoing 2:1 randomized Phase 2 AMPLIFY-7P trial The Company remains blinded to the Phase 2 AMPLIFY-7P trial clinical efficacy outcomes. Projected cash runway into Q3 2026, beyond the anticipated AMPLIFY-7P Phase 2 DFS analysis in 1H 2026 BOSTON, March 12, 2026 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or the “Company”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today reported financial results for the year ended December 31, 2025, and provided recent corporate and clinical updates. “In 2025, we made meaningful progress advancing ELI-002 7P in KRAS-mutant pancreatic cancer,” said Robert Connelly, Chief Executive Officer of Elicio. “We remain focused on completing the Phase 2 AMPLIFY-7P trial and reaching the event-driven primary DFS analysis expected in 1H 2026. We are encouraged by the continued observation of fewer disease progressions and deaths to date than projected in the 2:1 randomized trial, as well as by the durability of T-cell responses and clinical observations reported to date, which reinforce our confidence in ELI-002 7P’s potential to favorably impact outcomes. With capital expected to carry us beyond the anticipated DFS readout, we believe we are well positioned to deliver this important milestone and continue advancing our Amphiphile (“AMP”) platform in KRAS-mutant PDAC. We remain highly interested in the potential to expand the development of ELI-002 7P to neoadjuvant and metastatic PDAC and other KRAS+ tumors, with the goal of creating meaningful long-term value for patients and shareholders.” Recent Highlights In 2025, Elicio continued advancement of the randomized Phase 2 AMPLIFY-7P trial in post-resection mKRAS PDAC, with the event-driven primary DFS analysis remaining on track for an anticipated 1H 2026 readout In December 2025, Elicio reported evidence of antigen spreading to patient-specific neoantigens beyond mKRAS in the ongoing Phase 2 AMPLIFY-7P trial, demonstrating induction of de novo T cell responses against non-vaccine tumor neoantigens and further supporting the breadth and potential durability of the ELI-002 7P immune response in mKRAS-driven PDAC In November 2025, Elicio appointed Marc J. Wolfgang as Chief Technology Officer, strengthening the Company’s chemistry, manufacturing, and controls and technical operations capabilities to support late-stage development and potential commercialization readiness Upcoming Anticipated Milestones for the AMPLIFY-7P Phase 2 Trial Oral presentation in the Targeted Immunotherapies section at the World Vaccine Congress Washington 2026 (March 30–April 2, 2026; Walter E. Washington Convention Center, Washington, D.C.), scheduled for Wednesday, April 1st at 12:40 PM ET, by Dr. Peter DeMuth, Chief Scientific Officer, highlighting the ELI-002 platform overview, updated Phase 1 2P data (safety, T-cell responses, correlations to tumor biomarkers, RFS and OS), Phase 1 7P data, and Phase 2 AMPLIFY-7P updates (T-cell responses, HLA association and antigen spreading) ELI-002 to be highlighted by principal investigator Dr. Shubham Pant of The University of Texas MD Anderson Cancer Center (Houston, TX) during his pancreatic cancer presentation in the Advances in Pancreatic Cancer Research and Treatment session at the American Association for Cancer Research (“AACR”) Annual Meeting 2026 (April 17–22, 2026; San Diego, CA), scheduled for Tuesday, April 21st at 12:30 PT Event-driven primary DFS analysis of the Phase 2 AMPLIFY-7P trial anticipated in 1H 2026 Plans to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”) to finalize the Phase 3 trial design for ELI-002 7P in resected mKRAS PDAC following completion of the primary DFS analysis Finalize the Phase 3 protocol and advance ELI-002 7P toward initiation of a registrational study following the primary DFS endpoint analysis, subject to regulatory alignment. Continued translational and immunologic data updates from the AMPLIFY 7P program, including additional analyses of antigen spreading and T-cell durability 2025 Financial Results R&D expense for 2025 was $24.9 million, compared to $33.7 million for 2024. The decrease in R&D expense was primarily related to lower clinical costs as patients progressed into the observation phase of the Phase 2 study of ELI-002 7P. G&A expense for 2025 was $12.8 million, compared to $11.3 million for 2024. Net loss for 2025 was $39.5 million, compared to $51.9 million for 2024. Net loss for 2025 includes $1.9 million of non-cash other expense resulting from the change in fair value of the warrant liability. Net loss per share for 2025 was $2.58, compared to $4.25 for 2024. Cash and cash equivalents as of December 31, 2025, were $18.6 million, compared to $17.6 million as of December 31, 2024. The Company expects its current cash and cash equivalents and projected at-the-market program proceeds to support operations into Q3 2026, beyond the anticipated AMPLIFY-7P Phase 2 event-driven DFS analysis expected in 1H 2026. The Company raised net proceeds of approximately $4.9 million in Q4 2025 and $6.3 million in Q1 2026 to date, through its established at-the-market program. 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 successes 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 drives approximately 25% of all solid tumors. Elicio intends to expand ELI-002 7P clinical development not only for treatment in adjuvant pancreatic ductal adenocarcinoma, but also in neoadjuvant and metastatic PDAC settings, and for other mKRAS-positive cancers. 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 is being studied in an ongoing, randomized clinical trial in patients with mKRAS-positive PDAC who completed standard therapy but remain at high risk of relapse. ELI-002 also has been studied in patients with mKRAS-positive colorectal cancer (“CRC”) in Phase 1 studies. The updated AMPLIFY-201 Phase 1 data for PDAC and CRC was presented at the ESMO Immuno-Oncology Congress 2024 and included a 16.3-month median recurrence-free survival and 28.9-month median overall survival for the full study population. 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. 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 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 2P (2-peptide formulation) has been studied in the Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy (NCT04853017). ELI-002 7P (7-peptide formulation) is currently being studied in a Phase 1/2 (AMPLIFY-7P) trial in patients with mKRAS-driven pancreatic cancer (NCT05726864). 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 Amphiphile Platform Elicio’s proprietary AMP platform delivers investigational immunotherapeutics 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 preclinical 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 immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the local injection site, as it travels to lymphatic tissue. 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 existing cash and cash equivalents to support operations into the third quarter of 2026, beyond the anticipated event-driven primary DFS endpoint analysis expected in the first half of 2026; Elicio’s planned clinical programs, including the timing and outcome of planned clinical trials; the timing of the expected event-driven primary DFS endpoint analysis of the Phase 2 AMPLIFY-7P trial anticipated in the first half of 2026; the potential efficacy of Elicio’s product candidates, including ELI-002 7P; the potential of Elicio’s product candidates, including ELI-002 7P, to meaningfully improve outcomes for mKRAS PDAC patients; Elicio’s plan to request an End of Phase 2 meeting with the FDA to finalize the Phase 3 trial design for ELI-002 7P and the potential outcome of such meeting, if granted; Elicio’s plan to finalize its Phase 3 protocol and advance ELI-002 7P toward initiation of a registrational study following the primary DFS endpoint analysis, subject to regulatory alignment; continued translational and immunologic data updates from Elicio’s AMPLIFY 7P program; the potential participation and presentation at upcoming conferences and medical meetings; the potential for future expansion of ELI-002 to other indications including mKRAS positive lung cancer, neoadjuvant and metastatic PDAC, and other mKRAS positive cancers and in combination regimens for PDAC; 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 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, Elicio’s financial condition, including its anticipated cash runway, and ability to obtain the funding necessary to advance the development of ELI-002 7P and any other future product candidates, and Elicio’s ability to continue as a going concern; 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, including the event-driven primary DFS endpoint analysis from the Phase 2 AMPLIFY-7P trial expected in the first half of 2026; 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 [email protected]

Related articleQuarter not tagged2026-03-13

Elicio Therapeutics: Q4 Earnings Snapshot

Associated Press Finance

BOSTON (AP) — BOSTON (AP) — Elicio Therapeutics, Inc. (ELTX) on Thursday reported a loss of $7.7 million in its fourth quarter. The Boston-based company said it had a loss of 49 cents per share. For the year, the company reported a loss of $39.6 million, or $2.58 per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on ELTX at https://www.zacks.com/ap/ELTX

Related articleQuarter not tagged2025-11-14

Elicio Therapeutics: Q3 Earnings Snapshot

Associated Press Finance

BOSTON (AP) — BOSTON (AP) — Elicio Therapeutics, Inc. (ELTX) on Thursday reported a loss of $10.1 million in its third quarter. On a per-share basis, the Boston-based company said it had a loss of 60 cents. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on ELTX at https://www.zacks.com/ap/ELTX

Related articleQuarter not tagged2025-11-14

Elicio Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Updates

GlobeNewswire
In the ongoing Phase 2 AMPLIFY-7P study evaluating ELI-002 7P in patients with pancreatic ductal adenocarcinoma (“PDAC”), fewer disease progressions and deaths than projected have been observed as of November 6, 2025. Based on 2:1 randomization with twice as many patients in the ELI-002 7P treatment arm compared to the observation arm, Elicio believes the lower-than-projected number of disease progressions and deaths may reflect a favorable impact on disease-free survival (“DFS”); event-driven primary DFS analysis now anticipated in 1H 2026. Since the beginning of Q3 2025, the Company has raised gross proceeds of approximately $11.1 million through its established at-the-market program, extending Elicio’s cash runway through Q2 2026. Current cash position is expected to support operations beyond the anticipated Phase 2 AMPLIFY-7P event-driven primary DFS endpoint analysis anticipated in 1H 2026. The Company remains blinded to the Phase 2 AMPLIFY-7P trial clinical efficacy outcomes. BOSTON, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or the “Company”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today reported financial results for the third quarter ended September 30, 2025, and provided recent corporate and clinical updates. “We are encouraged to see fewer disease progressions and deaths in the Phase 2 AMPLIFY-7P study than originally projected in our statistical modeling. This may reflect a favorable impact on DFS. Because the DFS analysis is event-driven and triggered by a predefined number of events, we are updating our guidance for the timing of the event-driven primary DFS endpoint analysis to the first half of 2026. Importantly, we believe our current cash position will allow us to reach this critical catalyst and beyond as we continue advancing ELI-002 7P toward its potential to meaningfully improve outcomes for patients with KRAS-mutant pancreatic cancer,” said Robert Connelly, Chief Executive Officer of Elicio. Recent Highlights In November 2025, Elicio presented updated Phase 2 AMPLIFY-7P data at the Society for Immunotherapy of Cancer’s Annual Meeting, showing that ELI-002 7P induced mutant KRAS (“mKRAS”)-specific T cell responses in 99% (89/90) of evaluable patients with an 86% antigen response rate. In addition, Elicio reported 86.8% (6…Read full document

In the ongoing Phase 2 AMPLIFY-7P study evaluating ELI-002 7P in patients with pancreatic ductal adenocarcinoma (“PDAC”), fewer disease progressions and deaths than projected have been observed as of November 6, 2025. Based on 2:1 randomization with twice as many patients in the ELI-002 7P treatment arm compared to the observation arm, Elicio believes the lower-than-projected number of disease progressions and deaths may reflect a favorable impact on disease-free survival (“DFS”); event-driven primary DFS analysis now anticipated in 1H 2026. Since the beginning of Q3 2025, the Company has raised gross proceeds of approximately $11.1 million through its established at-the-market program, extending Elicio’s cash runway through Q2 2026. Current cash position is expected to support operations beyond the anticipated Phase 2 AMPLIFY-7P event-driven primary DFS endpoint analysis anticipated in 1H 2026. The Company remains blinded to the Phase 2 AMPLIFY-7P trial clinical efficacy outcomes. BOSTON, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or the “Company”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today reported financial results for the third quarter ended September 30, 2025, and provided recent corporate and clinical updates. “We are encouraged to see fewer disease progressions and deaths in the Phase 2 AMPLIFY-7P study than originally projected in our statistical modeling. This may reflect a favorable impact on DFS. Because the DFS analysis is event-driven and triggered by a predefined number of events, we are updating our guidance for the timing of the event-driven primary DFS endpoint analysis to the first half of 2026. Importantly, we believe our current cash position will allow us to reach this critical catalyst and beyond as we continue advancing ELI-002 7P toward its potential to meaningfully improve outcomes for patients with KRAS-mutant pancreatic cancer,” said Robert Connelly, Chief Executive Officer of Elicio. Recent Highlights In November 2025, Elicio presented updated Phase 2 AMPLIFY-7P data at the Society for Immunotherapy of Cancer’s Annual Meeting, showing that ELI-002 7P induced mutant KRAS (“mKRAS”)-specific T cell responses in 99% (89/90) of evaluable patients with an 86% antigen response rate. In addition, Elicio reported 86.8% (66/76) of evaluable patients induced cytotoxic mKRAS-specific T cell responses; 75% (57/76) induced CD8+ T cells and 75% (57/76) induced CD4+ T cells. Responses were observed across all seven mKRAS epitopes and occurred across a diverse HLA background, highlighting ELI-002 7P’s potential to benefit a broad and genetically diverse patient population. In October 2025, Elicio announced robust T cell responses across diverse HLA backgrounds in the ongoing Phase 2 AMPLIFY-7P trial. In September 2025, Elicio announced the planned investigator-initiated Phase 1 neoadjuvant trial of ELI-002 7P in resectable and borderline resectable PDAC led by Memorial Sloan Kettering Cancer Center and funded by the Lustgarten Foundation, assessing ELI-002 7P combined with mFOLFIRINOX with or without the anti-PD-1 antibody. The trial is designed to enroll 20 patients across two arms and is anticipated to begin in 1H 2026. In August 2025, Elicio announced the positive recommendation by the Independent Data Monitoring Committee (“IDMC”) to continue the ELI-002 7P randomized Phase 2 study in PDAC without modifications to the final analysis. In addition, the IDMC confirmed the favorable safety profile of ELI-002 7P as of such date; the Company viewed the IDMC’s positive recommendation as an indication that ELI-002 7P has shown preliminary signals of efficacy. Upcoming Anticipated Milestones for the Phase 2 AMPLIFY-7P Trial Upon reaching the event-driven primary DFS endpoint analysis, Elicio will request an End of Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”) to finalize the Phase 3 trial design for ELI-002 7P. Alignment on key elements of the Phase 3 study design was reached with the FDA at the End of Phase 1 meeting announced in Q1 2025. Third Quarter 2025 Financial Results R&D expense for the third quarter of 2025 was $5.0 million, compared to $7.2 million for the third quarter of 2024. The decrease of $2.2 million was primarily due to less clinical trial costs as patients progressed through the Phase 2 AMPLIFY-7P trial. G&A expense for the third quarter of 2025 was $3.0 million, compared to $3.1 million for the third quarter of 2024. The decrease of $0.1 million was primarily due to lower fees incurred in connection with general corporate matters. Net loss for the third quarter of 2025 was $10.1 million, compared to $18.8 million for the third quarter of 2024. Net loss for the third quarter of 2025 includes $2.0 million in other expense. Net loss per share for the third quarter of 2025 was $0.60 compared to $1.39 for the third quarter of 2024. Cash and cash equivalents as of September 30, 2025 were $20.6 million. The Company expects that its current cash and cash equivalents will support operations through Q2 2026, beyond the anticipated Phase 2 AMPLIFY-7P event-driven primary DFS endpoint analysis anticipated in 1H 2026. 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 successes in the personalized cancer immunotherapy space to develop effective, off-the-shelf immunotherapies. Elicio’s Amphiphile (“AMP”) technology aims to enhance the education, activation and amplification of cancer-specific T cells relative to conventional immunization strategies, with the goal of promoting durable cancer immunosurveillance in patients. Elicio’s ELI-002 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 is being studied in an ongoing, randomized clinical trial in patients with mKRAS-positive pancreatic cancer who completed standard therapy but remain at high risk of relapse. ELI-002 also has been studied in patients with mKRAS-positive colorectal cancer (“CRC”) in Phase 1 studies. The updated AMPLIFY-201 Phase 1 data for PDAC and CRC was presented at the ESMO Immuno-Oncology Congress 2024 and included a 16.3-month median recurrence-free survival and 28.9-month median overall survival for the full study population. In the future, Elicio plans to expand ELI-002 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. 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 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 2P (2-peptide formulation) has been studied in the Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy (NCT04853017). ELI-002 7P (7-peptide formulation) is currently being studied in a Phase 1/2 (AMPLIFY-7P) trial in patients with mKRAS-driven pancreatic cancer (NCT05726864). 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 Amphiphile Platform Elicio’s proprietary AMP platform delivers investigational immunotherapeutics 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 preclinical 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 immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the local injection site, as it travels to lymphatic tissue. 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 existing cash and cash equivalents to support operations; Elicio’s planned clinical programs, including the timing and outcome of planned clinical trials; the timing of the anticipated event-driven primary DFS endpoint analysis of the Phase 2 AMPLIFY-7P trial; the potential efficacy of Elicio’s product candidates, including ELI-002 7P; the potential of Elicio’s product candidates, including ELI-002 7P, to meaningfully improve outcomes for mKRAS PDAC patients; Elicio’s plan to request an End of Phase 2 meeting with the FDA to finalize the Phase 3 trial design for ELI-002 7P and the potential outcome of such meeting, if granted; the potential for future expansion of ELI-002 to other indications, including mKRAS positive lung cancer, other mKRAS positive cancers and in combination regimens for PDAC; 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 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, Elicio’s financial condition, including its anticipated cash runway, and ability to obtain the funding necessary to advance the development of ELI-002 7P and any other future product candidates, and Elicio’s ability to continue as a going concern; 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, including the event-driven primary DFS endpoint analysis from the Phase 2 AMPLIFY-7P trial; 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, 2024, filed with the SEC on March 31, 2025, Elicio’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 13, 2025, and Elicio’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 7, 2025, 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 [email protected]

Related articleQuarter not tagged2025-08-08

Elicio Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Updates

GlobeNewswire
Recent positive recommendation by the Independent Data Monitoring Committee (“IDMC”) to continue ELI-002 7P randomized Phase 2 study in pancreatic cancer without modifications to final analysis Event-driven final analysis focused on disease-free survival (“DFS”) expected in Q4 2025 Secured $10 million financing in Q2 2025; Current cash position expected to support operations beyond anticipated AMPLIFY-7P Phase 2 final analysis BOSTON, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or the “Company”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today reported financial results for the second quarter ended June 30, 2025, and provided recent corporate and clinical updates. “Most recently, we were pleased to receive the IDMC’s positive recommendation to continue the AMPLIFY-7P study to final analysis without modification, which we believe indicates preliminary signals of efficacy from ELI-002 7P in the treatment of pancreatic ductal adenocarcinoma (“PDAC”),” said Robert Connelly, Chief Executive Officer of Elicio Therapeutics. “With final DFS data expected in the fourth quarter of this year, we are focused on advancing clinical preparations for a potential pivotal Phase 3 trial. We previously reached alignment with the U.S. Food and Drug Administration (“FDA”) on the key elements of the planned pivotal Phase 3 study design, and, upon final event-driven DFS analysis, plan to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the ELI-002 Phase 3 study. Importantly, during the second quarter, we secured $10 million in additional financing to extend our cash runway into the first quarter of 2026, beyond the anticipated final DFS analysis.” Recent Highlights In August 2025, Elicio announced a positive recommendation by the IDMC to continue the ELI-002 7P randomized Phase 2 study in PDAC without modifications to final analysis, based on a pre-specified unblinded interim analysis of efficacy and safety data. In addition, the IDMC confirmed the favorable safety profile of ELI-002 7P to date. In June 2025, Elicio strengthened its cash position with a $10 million non-dilutive financing. In June, Elicio hosted a virtual KOL event highlighting the Company’s AMP platform and lead program, ELI-002, and the unmet need in mutant KRAS (“m…Read full document

Recent positive recommendation by the Independent Data Monitoring Committee (“IDMC”) to continue ELI-002 7P randomized Phase 2 study in pancreatic cancer without modifications to final analysis Event-driven final analysis focused on disease-free survival (“DFS”) expected in Q4 2025 Secured $10 million financing in Q2 2025; Current cash position expected to support operations beyond anticipated AMPLIFY-7P Phase 2 final analysis BOSTON, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or the “Company”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today reported financial results for the second quarter ended June 30, 2025, and provided recent corporate and clinical updates. “Most recently, we were pleased to receive the IDMC’s positive recommendation to continue the AMPLIFY-7P study to final analysis without modification, which we believe indicates preliminary signals of efficacy from ELI-002 7P in the treatment of pancreatic ductal adenocarcinoma (“PDAC”),” said Robert Connelly, Chief Executive Officer of Elicio Therapeutics. “With final DFS data expected in the fourth quarter of this year, we are focused on advancing clinical preparations for a potential pivotal Phase 3 trial. We previously reached alignment with the U.S. Food and Drug Administration (“FDA”) on the key elements of the planned pivotal Phase 3 study design, and, upon final event-driven DFS analysis, plan to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the ELI-002 Phase 3 study. Importantly, during the second quarter, we secured $10 million in additional financing to extend our cash runway into the first quarter of 2026, beyond the anticipated final DFS analysis.” Recent Highlights In August 2025, Elicio announced a positive recommendation by the IDMC to continue the ELI-002 7P randomized Phase 2 study in PDAC without modifications to final analysis, based on a pre-specified unblinded interim analysis of efficacy and safety data. In addition, the IDMC confirmed the favorable safety profile of ELI-002 7P to date. In June 2025, Elicio strengthened its cash position with a $10 million non-dilutive financing. In June, Elicio hosted a virtual KOL event highlighting the Company’s AMP platform and lead program, ELI-002, and the unmet need in mutant KRAS (“mKRAS”)-driven PDAC. Upcoming Anticipated Milestones DFS event-driven final analysis of Phase 2 AMPLIFY-7P clinical trial anticipated in Q4 2025. Upon final DFS analysis, request and conduct End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the pivotal Phase 3 trial for ELI-002. Second Quarter 2025 Financial Results R&D expense for the second quarter of 2025 was $7.0 million, compared to $8.2 million for the second quarter of 2024. The decrease of $1.2 million was primarily due to less clinical trial manufacturing as we advanced ELI-002 7P clinical development. G&A expense for the second quarter of 2025 was $3.1 million, compared to $2.7 million for the second quarter of 2024. The increase of $0.4 million was primarily due to higher professional fees in connection with the June 2025 Promissory Note Financing. Net loss for the second quarter of 2025 was $10.6 million, compared to $7.2 million for the second quarter of 2024. Net loss for the second quarter of 2025 included the change in fair value associated with outstanding common warrants and recognition of grant income. Net loss per share for the second quarter of 2025 was $0.66 compared to $0.64 for the second quarter of 2024. Cash and cash equivalents, as of June 30, 2025, were $22.1 million. The Company expects that its current cash and cash equivalents will support operations into Q1 2026, beyond the anticipated AMPLIFY-7P Phase 2 final analysis. 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 successes in the personalized cancer vaccine space to develop effective, off-the-shelf vaccines. Elicio’s Amphiphile (“AMP”) technology aims to enhance the education, activation and amplification of cancer-specific T cells relative to conventional vaccination strategies, with the goal of promoting durable cancer immunosurveillance in patients. Elicio’s ELI-002 lead program is an off-the-shelf vaccine candidate targeting the most common KRAS mutations, which drive approximately 25% of all solid tumors. Off-the-shelf vaccine 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 vaccines approaches. ELI-002 is being studied in an ongoing, randomized clinical trial in patients with mKRAS-positive pancreatic cancer who completed standard therapy but remain at high risk of relapse. ELI-002 also has been studied in patients with mKRAS-positive colorectal cancer (“CRC”) in Phase 1 studies. The updated AMPLIFY-201 Phase 1 data for PDAC and CRC was presented at the ESMO Immuno-Oncology Congress 2024 and included a 16.3-month median recurrence-free survival and 28.9-month median overall survival for the full study population. In the future, Elicio plans to expand ELI-002 to other indications including mKRAS positive lung cancer and other mKRAS positive cancers. Elicio’s pipeline includes additional off-the-shelf therapeutic cancer vaccines 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. About ELI-002 Elicio’s lead product candidate, ELI-002, is a structurally novel investigational AMP cancer vaccine 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 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 2P (2-peptide formulation) has been studied in the Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy (NCT04853017). ELI-002 7P (7-peptide formulation) is currently being studied in a Phase 1/2 (AMPLIFY-7P) trial in patients with mKRAS-driven pancreatic cancer (NCT05726864). 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 Amphiphile Platform Elicio’s proprietary AMP platform delivers investigational immunotherapeutics 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 preclinical 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 immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the local injection site, as it travels to lymphatic tissue. 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 existing cash and cash equivalents to support operations into the first quarter of 2026, beyond the anticipated AMPLIFY-7P Phase 2 event-driven final DFS analysis expected in the fourth quarter of 2025; Elicio’s planned clinical programs, including the timing and outcome of planned clinical trials; the timing of the expected event-driven final DFS analysis of the Phase 2 AMPLIFY-7P clinical trial anticipated in the fourth quarter of 2025; the potential efficacy of Elicio’s product candidates, including ELI-002 7P; the potential of Elicio’s product candidates, including ELI-002; Elicio’s plan to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the ELI-002 Phase 3 study and the potential outcome of such meeting, if granted; the potential for future expansion of ELI-002 to other indications, including in combination regimens for PDAC and colorectal cancer; the potential benefits and effectiveness of off-the-shelf vaccine 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. 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, Elicio’s financial condition, including its anticipated cash runway, and ability to obtain the funding necessary to advance the development of ELI-002 and any other future product candidates, and Elicio’s ability to continue as a going concern; Elicio’s plans to develop and commercialize its product candidates, including ELI-002; the timing of initiation of Elicio’s planned clinical trials; the timing of the availability of data from Elicio’s clinical trials, including the event-driven final DFS analysis from the Phase 2 AMPLIFY-7P trial expected in the fourth quarter of 2025; 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 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 Elicio’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 31, 2025, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 13, 2025, 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 [email protected]

Related articleQuarter not tagged2025-08-08

Elicio Therapeutics: Q2 Earnings Snapshot

Associated Press Finance

BOSTON (AP) — BOSTON (AP) — Elicio Therapeutics, Inc. (ELTX) on Thursday reported a loss of $10.6 million in its second quarter. On a per-share basis, the Boston-based company said it had a loss of 66 cents. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on ELTX at https://www.zacks.com/ap/ELTX

Related articleQuarter not tagged2025-05-14

Elicio Therapeutics: Q1 Earnings Snapshot

Associated Press Finance

BOSTON (AP) — BOSTON (AP) — Elicio Therapeutics, Inc. (ELTX) on Tuesday reported a loss of $11.2 million in its first quarter. The Boston-based company said it had a loss of 87 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on ELTX at https://www.zacks.com/ap/ELTX

As of 2026-10-24 • Updated weeklySource: Earnings sourceIngestion runbook