- Trial Phase
- Phase 2 (completed — missed primary endpoint)
- Time to Market
- At least 4-6 years (Phase 3 not yet designed, then BLA filing and review)
- Why 4/10
- No hard dated binary catalyst within the next ~12 months. The Phase 2 AMPLIFY-7P readout (June 15, 2026) was the defining make-or-break catalyst — it missed its primary endpoint. The stock already crashed 47-72%. A refined Phase 3 plan is in development but not yet designed/initiated, and a planned Phase 1 combo study is subject to funding. Without a dated pivotal readout or PDUFA, impactScore is capped at 4.
The Phase 2 miss on the primary endpoint is a major setback. The stock already repriced sharply. The company now faces a cash crunch ($14.9M at Q1 end, ~$11.6M quarterly burn) and just announced a ~20% dilutive $15M offering at $3.43/share. Watch for: (1) whether the refined Phase 3 strategy in R0 resected patients finds regulatory traction, (2) financing news beyond the current ATM and note, (3) any partnership interest in the KRAS vaccine platform.
Price Chart
Executive Summary
ELI-002 is Elicio Therapeutics' lead and only clinical-stage asset — a therapeutic cancer vaccine targeting KRAS-mutant tumors. It showed promising Phase 1 results (published in Nature Medicine) with 84% of patients mounting T-cell responses that correlated with improved survival. However, the pivotal Phase 2 AMPLIFY-7P trial in adjuvant pancreatic cancer missed its primary endpoint of disease-free survival in June 2026, sending shares down 47-72%. Post-hoc analyses suggest benefit in patients with lower residual disease, and rare complete responses were seen in 3 metastatic patients when combined with checkpoint inhibitors. The company is now pursuing a refined Phase 3 strategy while facing a cash runway through Q4 2026 (at best) and having just raised $15M in a dilutive offering at $3.43/share. Analysts remain bullish (7 Buy, 1 Hold) with a mean price target of $20.67 representing ~300% upside from recent levels, but the stock carries extreme risk given the Phase 2 failure, single-asset pipeline, and precarious finances.
How It Works
ELI-002 is a therapeutic cancer vaccine (not a prevention vaccine). It uses Elicio's proprietary Amphiphile (AMP) technology to deliver mutant KRAS protein fragments directly to lymph nodes, training the patient's immune system to recognize and attack cancer cells carrying KRAS mutations. The "7P" version targets the 7 most common KRAS mutations, which drive roughly 25% of all solid tumors (including pancreatic, colorectal, and lung cancers). It is given as a series of subcutaneous injections.
Trial Status
Phase 2 AMPLIFY-7P (ELI-002 7P, 7-peptide formulation) randomized 135 adjuvant pancreatic cancer patients 2:1 vs observation. Did NOT meet primary endpoint of disease-free survival (DFS) in the intent-to-treat population (reported June 15, 2026). Post-hoc analysis showed DFS signal in R0-resected (lower residual disease) patients. Company plans a refined Phase 3 strategy in that subset with additional dosing. Phase 1 AMPLIFY-201 (ELI-002 2P, 2-peptide) completed and published in Nature Medicine showing 84% immune response rate and correlation with improved outcomes. Additionally, 3 metastatic PDAC patients achieved confirmed complete radiographic/metabolic responses after ELI-002 7P followed by nivolumab-based therapy — a Phase 1 combo study is planned subject to funding.
The Two-Sided Case
Upcoming Catalysts
- Refined Phase 3 study design announcement for ELI-002 7P in R0-resected adjuvant PDAC (timing TBD)
- Phase 1 initiation of ELI-002 7P + checkpoint inhibition in 1L metastatic PDAC (subject to funding; initial efficacy signals expected within ~36 months of start)
- Possible partnership or out-licensing deal for the KRAS vaccine platform
- Cash runway updates — additional equity financing likely needed given ~$11.6M/quarter burn rate
- August 2026 lock-up expiration from the $15M July offering could create further selling pressure
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Elicio Therapeutics, Inc. 8-K ELTX ·Originating report