Elicio Therapeutics Reports 2024 Financial Results and Provides Corporate Updates

Core Insights - Elicio Therapeutics has made significant advancements in its cancer immunotherapy pipeline, notably completing enrollment in its first randomized Phase 2 clinical trial, AMPLIFY-7P, which is expected to yield interim analysis results in Q3 2025 [2][5] - The company has aligned with the FDA on key elements for the Phase 3 study design of ELI-002, focusing on dose, patient population, and primary endpoint analysis [1][5] - Elicio has strengthened its cash position, with expectations to support operations into Q4 2025, beyond the upcoming interim analysis [1][8] Recent Highlights - Elicio presented promising Phase 1a data for ELI-002, showing a strong correlation between T cell response and anti-tumor activity across two monotherapy trials involving 39 patients [2] - The Phase 2 AMPLIFY-7P trial has successfully enrolled 144 patients with post-resection mKRAS pancreatic ductal adenocarcinoma, randomized 2:1 to receive ELI-002 or standard care [5] - Updated results from the Phase 1a AMPLIFY-201 trial indicated a median recurrence-free survival of 16.3 months and a median overall survival of 28.9 months [5] Financial Overview - Research and development expenses for 2024 were $33.7 million, up from $23.8 million in 2023, primarily due to clinical trial costs [6] - General and administrative expenses decreased slightly to $11.3 million in 2024 from $11.9 million in 2023 [6] - The net loss for 2024 was $51.9 million, compared to $35.2 million in 2023, with a net loss per share of $4.25 [7] Cash Position - As of December 31, 2024, Elicio had cash and cash equivalents of $17.6 million, an increase from $12.9 million in 2023 [7][10] - The company anticipates that its current cash position, bolstered by a $10 million direct offering in January 2025, will support operations into Q4 2025 [8] Upcoming Milestones - The DFS event-driven interim analysis for the Phase 2 AMPLIFY-7P trial is expected in Q3 2025, contingent on the rate of event accrual [5] - Elicio aims to finalize the pivotal Phase 3 trial protocol for ELI-002 in resected mKRAS pancreatic ductal adenocarcinoma in the second half of 2025 [5]