Elicio Therapeutics Reports 2024 Financial Results and Provides Corporate Updates
Completed enrollment of Phase 2 AMPLIFY-7P randomized study; disease-free survival ("DFS") event-driven interim analysis expected in Q3 2025
Aligned with U.S. Food and Drug Administration ("FDA") on key elements of planned ELI-002 Phase 3 study design, including dose, patient population and primary endpoint analysis
Strengthened cash position to support operations beyond the anticipated AMPLIFY-7P Phase 2 interim analysis
BOSTON, March 31, 2025 (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 year ending December 31, 2024 and provided recent corporate and clinical updates.
"We made substantial progress in 2024 advancing our cancer immunotherapy pipeline and achieving major milestones, including completing enrollment in our first randomized Phase 2 clinical trial. We believe that ELI-002 could play a transformational role in preventing the recurrence of difficult-to-treat KRAS-mutant cancers," said Robert Connelly, Chief Executive Officer of Elicio. "During the fourth quarter, we presented highly encouraging ELI-002 Phase 1a data at major medical meetings. Across two monotherapy trials that enrolled a total of 39 patients, we observed strong concordance between T cell response and anti-tumor activity—with antigen spreading beyond KRAS to other personalized tumor neo-antigens. Data presented at the Society for Immunotherapy of Cancer ("SITC") 2024 Annual Meeting and the European Society for Medical Oncology ("ESMO")Immuno-Oncology Congress 2024 pointed to a potential DFS benefit for patients. Reflecting strong interest from patients and trial investigators, enrollment in our Phase 2 AMPLIFY-7P trial was completed on schedule, and the study is progressing toward a DFS event-driven interim analysis expected in Q3 2025, depending on rate of event accrual. We're looking forward to working with our investigators to initiate a clinical study of ELI-002 in additional KRAS-mutated tumor indications. Additionally, we have taken steps to strengthen our balance sheet to support operations into Q4 2025, beyond the upcoming interim analysis."
Recent Highlights
In March 2025, Elicio appointed Preetam Shah, Ph.D., MBA, as Chief Strategy and Financial Officer.
In January 2025, Elicio strengthened its cash position with a $10.0 million registered direct offering of common stock.
In January 2025, Elicio reached alignment with regulatory authorities on a registrational strategy for ELI-002 in post-resection (adjuvant setting) mKRAS pancreatic ductal adenocarcinoma ("PDAC"). Specifically, Elicio aligned with the FDA on key elements of a planned Phase 3 study design—including dose, schedule, patient population and primary endpoint analysis based on DFS.
In December 2024, Elicio announced the completion of enrollment of the randomized Phase 2 AMPLIFY-7P clinical trial (NCT05726864). The trial has successfully enrolled 144 post-resection mKRAS PDAC patients, randomized 2:1 to receive ELI-002 or observational standard-of-care.
In December 2024, Elicio presented updated results from the Phase 1a AMPLIFY-201 clinical trial (NCT04853017) of ELI-002 at the ESMO Immuno-Oncology Congress 2024. Updated Phase 1a results included a 16.3-month median recurrence-free survival ("mRFS"), a 28.9-month median overall survival ("mOS") from full study population and a strong correlation between mRFS and strength of T cell response.
In November 2024, Elicio presented updated translational data from the Phase 1a AMPLIFY-7P clinical trial (NCT05726864) at the SITC 2024 Annual Meeting, demonstrating favorable safety, durable and dose-dependent T cell responses targeting KRAS mutations and induced responses to patient-specific neoantigens and a strong correlation between DFS and T cell response.
Upcoming Anticipated Milestones
DFS event-driven interim analysis of Phase 2 AMPLIFY-7P clinical trial in Q3 2025, depending on rate of event accrual
Potential to finalize pivotal Phase 3 trial protocol for ELI-002 in resected mKRAS PDAC in H2 2025
2024 Financial Results
R&D expense for 2024 was $33.7 million, compared to $23.8 million 2023. The increased R&D expense was primarily related to clinical trial expenses associated with the ongoing Phase 2 AMPLIFY-7P Phase 2, partially offset by cost-cutting operational changes implemented during Q3 2024.
G&A expense for 2024 was $11.3 million, compared to $11.9 million for 2023.
Net loss for 2024 was $51.9 million, compared to $35.2 million for 2023. Net loss for 2024 includes $6.9 million of non-cash other income resulting from the change in fair value of the warrant liability. Net loss per share for 2024 was $4.25 compared to $6.96 for 2023.
Cash and cash equivalents, as of December 31, 2024, were $17.6 million, compared to $12.9 million as of December 31, 2023.
Including $10.0 million in gross proceeds from the January 2025 registered direct offering, the Company expects current cash and cash equivalents to support operations into Q4 2025, beyond the anticipated AMPLIFY-7P Phase 2 interim analysis.
ELICIO THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(unaudited)
Year Ended December 31,
2024
2023
Operating expenses:
Research and development
$
33,656
$
23,849
General and administrative
11,330
11,896
Total operating expenses
44,986
