• AMPLIFY-7P Phase 1 preliminary disease-free ("DFS") survival demonstrates strong correlation between T cell response and reduced risk of progression or death• AMPLIFY-7P Phase 1 data presented at ASCO demonstrated 100% of patients develop mKRAS-specific T-cell response with ~66% of responses including both CD4+ and CD8+ T cells• Long term follow up of the AMPLIFY-201 Phase 1 study will be terminated, and long term follow up of the AMPLIFY-7P Phase 1 study will be minimized to collect only overall survival to preserve resources with updated data to be shared at upcoming medical meetings• AMPLIFY-7P Phase 2 randomized clinical trial anticipated to complete 135-patient enrollment in the fourth quarter of 2024• $43 million raised in 2024 funds Elicio into the second quarter of 2025 BOSTON, Aug. 13, 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 second quarter ended June 30, 2024 and provided recent corporate and clinical updates. "During the second quarter, we continued to make great progress with our lead program sharing the first clinical data from the 7-peptide version of ELI-002 and are continuing to see robust enrollment in the randomized Phase 2 trial. We remain encouraged by the early clinical data from the ELI-002 Phase 1 trial, including T-cell response and biomarker reduction, and are energized by the rate of enrollment in the ongoing Phase 2 trial. Having completed enrollment and dosing of 39 patients across both Phase 1 trials, we will be winding down the Phase 1 trials after conducting a final data cut later this summer and look forward to sharing the longer-term follow up data at upcoming medical meetings," said Robert Connelly, Chief Executive Officer of Elicio. "With the recently announced financings we are funded into the second quarter of 2025 beyond when we expect to have the interim analysis readout of the ongoing randomized Phase 2 trial of ELI-002 monotherapy in PDAC." Christopher Haqq, M.D., Ph.D., Elicio's Chief Medical Officer, added, "We were encouraged by and excited to share the initial clinical data from the 7-peptide ELI-002 Phase 1 trial. The data demonstrated the 7-peptide formulation is well-tolerated while generating a significantly larger T cell response compared to the 2-peptide formulation. Importantly, the ELI-002 7P immune response included CD4+ and CD8+ T cells and generated antigen-spreading as was seen in the 2-peptide data shared earlier this year. As of our May 24, 2024 data cutoff date, preliminary data showed patients receiving ELI-002 7P at the recommended Phase 2 dose ("RP2D") of 4.9 mg AMP-peptide were yet to reach the median disease-free survival ("mDFS"). Based on the potential to target mutant KRAS using the immune response supported by initial Phase 1 data, we look forward to demonstrating the potential of ELI-002 in late phase trials as clinical development proceeds." 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 treatment and potentially reducing the chance of bypass resistance mechanisms. Preliminary Phase 1a trial data based on the May 24, 2024 data cutoff date was shared in June 2024. The mDFS has not yet been reached (n=14). The mDFS has not been reached in patients receiving the 4.9mg AMP-peptide dose (n=8) vs. 12.6 weeks for patients receiving the 1.4mg AMP-peptide dose (n=6). Patients achieving a reduction in their tumor biomarker levels had no progression events vs. mDFS of 11.0 weeks for patients whose tumor biomarker did not respond to ELI-002 7P. Patients with an above median T cell response to ELI-002 have had no progression events. As of the December 18, 2023 data cutoff date, polyfunctional mKRAS-specific T cells were observed in 100% (n = 11/11) of evaluable patients. Both CD8+ and CD4+ responses were induced in 66.7% (4/6) of evaluable patients, at the RP2D 4.9 mg dose level, with higher median fold-change from baseline. Biomarker reductions were observed in 2/5 (40%) at the 1.4 mg AMP-Peptides 7P dose level and in 5/7 (71%) at the RP2D 4.9 mg dose level in patients with reductions/clearance observed for all the common G12 (G12D, G12V, G12R) and G13 (D) KRAS mutations enrolled in the study to date. Minimum residual disease clearance was observed in one (1) G12V pancreatic ("PDAC") patient at 4.9 mg. Antigen-spreading was observed with increased T cell responses targeting non-immunizing, personalized tumor neoantigens were observed in 7/10 (70%) evaluable patients, 6/6 (100%) evaluable patients treated at the 4.9 mg RP2D dose level. No dose-limiting toxicities, no treatment-related serious adverse events and no cytokine release syndrome were observed. Randomized Phase 2 trial enrollment expected to complete in the fourth quarter of 2024. Upcoming Anticipated Milestones AMPLIFY-201: Provide updated immunogenicity and relapse free survival data in the fourth quarter of 2024. AMPLIFY-7P: Provide updated preliminary DFS data from ELI-002 7P monotherapy Phase 1a arm in the first quarter of 2025. 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. Second Quarter 2024 Financial Results R&D expense for the second quarter of 2024 was $8.2 million, compared to $4.9 million for the second 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 and Phase 2 trials. G&A expense for the second quarter of 2024 was $2.7 million, compared to $2.8 million for the second quarter of 2023. Net loss for the second quarter of 2024 was $7.2 million, compared to $7.6 million for the second quarter of 2023. Net loss for the second quarter of 2024 includes $3.6 million of non-cash other income resulting from the change in fair value of the warrant liability. Net loss per share for the second quarter of 2024 was $0.64 compared to $2.61 for the second quarter of 2023. Cash and cash equivalents as of June 30, 2024, were $3.4 million, compared to $12.9 million as of December 31, 2023. Cash and cash equivalents as of June 30, 2024 does not include $9.9 million of net proceeds from the public offering that was received on July 1, 2024 and the $19.7 million of net proceeds from the convertible note financing that was received on August 12, 2024. ELICIO THERAPEUTICS, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts)(unaudited)   Three Months Ended June 30,       2024       2023     Operating expenses: