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.
       
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(unaudited)
       
  Three Months Ended June 30,
    2025       2024  
Operating expenses:      
Research and development $ 7,006     $ 8,180  
General and administrative   3,085       2,744  
Total operating expenses   10,091       10,924  
Loss from operations   (10,091 )     (10,924 )
Total other (expense) income, net   (470 )     3,695