ELI-002 2P Phase 1 preliminary data published in Nature Medicine ELI-002 2P Phase 1 data characterizing the CD4 and CD8 profile of the KRAS immune response and ELI-002-generated antigen spreading presented at the AACR Annual Meeting ELI-002 7P Phase 1 preliminary data to be presented at the ASCO Annual Meeting ("ASCO") in June 2024 ELI-002 7P randomized Phase 2 trial enrollment expected to complete in fourth quarter 2024 BOSTON, May 15, 2024 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (NASDAQ:ELTX, "Elicio Therapeutics" or "Elicio")), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today reported financial results for the first quarter ended March 31, 2024, and provided recent corporate and clinical updates. "During the first quarter, we continued to make great progress with our lead program, ELI-002, seeing the first-in-human Phase 1 data on the 2P formulation published in Nature Medicine. We also began enrolling patients with pancreatic cancer in the randomized Phase 2 trial of the 7P formulation," said Robert Connelly, Elicio's Chief Executive Officer. "We look forward to sharing preliminary data from the ELI-002 7P Phase 1 cohort at ASCO while focusing on completing enrollment for the Phase 2 randomized cohort, which is expected by the end of 2024." Christopher Haqq, M.D., Ph.D., Elicio's Executive Vice President, Head of Research and Development, and Chief Medical Officer, added, "We have continued to analyze and publish data from our first-in-human study characterizing the robust and differentiated T cell response generated by ELI-002. Building on the magnitude of the KRAS-specific T cell response including both CD4+ and CD8+ recent data presented at AACR, we also demonstrated that ELI-002's mechanism of action includes antigen-spreading, where personal neoantigens are targeted alongside the KRAS-specific response that may enhance clinical activity." Corporate Updates AMPLIFY-201 trial: Multicenter Phase 1 trial assessing the safety, immunogenicity, and antitumor activity of ELI-002 2P monotherapy in patients with mutant KRAS-driven solid tumors who are at high risk for relapse following standard surgery and chemotherapy. Data from the first-in-human study of ELI-002 2P published in Nature Medicine Presented clinical data at the AACR Annual Meeting highlighting results suggesting durable immunogenicity of ELI-002 2P with high relapse-risk mKRAS-driven colorectal cancer ("CRC") and pancreatic ductal adenocarcinoma ("PDAC"). A majority of patients who received ELI-002 booster immunizations maintained or increased mKRAS-specific T cell responses relative to baseline. Durable responses were associated with increased memory T cell phenotype compared to baseline. ELI-002 induced increased mKRAS-specific CD4 and CD8 T cells with cytotoxic function, associated with increased memory phenotype in a majority of patients. CD4+ T regulatory cells were not induced after ELI-002 2P immunization. Antigen spreading was observed with T cell responses to patient-specific tumor mutations (not mKRAS) after ELI-002 2P vaccination in a majority of patients tested. No safety concerns were identified. No dose limiting toxicities and no ≥ grade 3 treatment related adverse events were observed. Data suggested several advantages of ELI-002 including lymph node-targeted vaccine design, potent immunogenicity with durable and balanced CD4+ and CD8+ T cell responses, increased T cell cytotoxic function, and antigen spreading to induce T cells targeting additional tumor mutations beyond mKRAS. AMPLIFY-7P trial: A multicenter Phase 1/2 trial assessing ELI-002 7P in patients with high relapse risk mutant KRAS-driven solid tumors. The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations expanding the number of patients eligible for inclusion and potentially reducing the chance of bypass resistance mechanisms. Preliminary data from the Phase 1a trial to be presented at ASCO in June 2024. Randomized Phase 2 trial enrollment initiated in January 2024. Upcoming Anticipated Milestones AMPLIFY-7P: Present preliminary data on ELI-002 7P monotherapy from Phase 1a arm at ASCO in June 2024. AMPLIFY-7P: Complete enrollment in the randomized Phase 2 trial in the fourth quarter of 2024 with interim analysis expected in the first quarter of 2025. AMPLIFY-201: Provide updated immunogenicity and relapse-free survival data in the fourth quarter of 2024. First Quarter 2024 Financial Results R&D expense for the first quarter of 2024 was $7.6 million, compared to $5.5 million for the first quarter of 2023. The increase in R&D expense was primarily due to increased clinical trial expenses associated with the ongoing AMPLIFY-7P Phase 1a trial and initiation of the AMPLIFY-7P Phase 2 trial. G&A expense for the first quarter of 2024 was $2.7 million, compared to $2.3 million for the first quarter of 2023. The increase in G&A expense was primarily attributable to professional fees, personnel expense and insurance associated with operating as a public company. Net loss for the first quarter of 2024 was $11.8 million, compared to $8.0 million for the first quarter of 2023. Net loss per share for the first quarter of 2024 was $1.15 compared to $24.77 for the first quarter of 2023. Cash and cash equivalents as of March 31, 2024, were $11.9 million, compared to $12.9 million as of December 31, 2023. ELICIO THERAPEUTICS, INC.Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share amounts)(unaudited)         Three Months Ended March 31,       2024       2023     Operating expenses:         Research and development $ 7,559     $ 5,484     General and administrative   2,682       2,321     Total operating expenses   10,241       7,805     Loss from operations