Elicio Therapeutics Plans End-of-Phase 2 FDA Meeting for ELI-002 7P Following Mid-2026 PDAC Readout
Elicio plans an End-of-Phase 2 FDA meeting for ELI-002 7P in KRAS-mutant PDAC following mid-2026 Phase 2 DFS data readout.
Breaking News
May 12, 2026
Pharma Now Editorial Team
Elicio Therapeutics is positioning ELI-002 7P for a pivotal regulatory conversation with the FDA, contingent on mid-2026 primary data from the Phase 2 AMPLIFY-7P trial in post-resection KRAS-mutant pancreatic ductal adenocarcinoma. For regulatory affairs leads tracking novel immunotherapy platforms, the planned End-of-Phase 2 meeting represents the next critical alignment point before any registrational study can be scoped.
The event-driven primary disease-free survival endpoint analysis for the randomized 2:1 AMPLIFY-7P study is anticipated mid-year 2026. Elicio noted that fewer disease progressions and deaths than projected have been observed to date, though the company remains blinded to clinical efficacy outcomes. Following the DFS readout, the company intends to request an End-of-Phase 2 meeting to align with FDA on Phase 3 trial design for resected mKRAS PDAC, a step that will determine the evidentiary and operational requirements for a registrational program built around a novel amphiphile (AMP) immunotherapy platform.
The regulatory pathway discussion will unfold against a constrained financial backdrop. Cash and cash equivalents stood at $14.9 million as of March 31, 2026, down from $18.6 million at year-end 2025. Elicio raised aggregate net proceeds of approximately $13.0 million through its at-the-market program, $8.0 million in Q1 2026 and an additional $5.0 million in Q2 2026 to date, extending the projected cash runway into Q4 2026, beyond the anticipated DFS readout.
On the cost side, R&D expenses declined to $6.8 million in Q1 2026 from $7.8 million in Q1 2025, reflecting the trial's transition from active dosing into follow-up. G&A expenses rose to $3.8 million from $3.0 million over the same period, driven by increased headcount and professional fees. Net loss for Q1 2026 was $11.8 million, including $1.0 million in non-cash expense from warrant liability fair-value changes.
The End-of-Phase 2 meeting outcome will set the parameters, endpoint selection, comparator arm, patient population definition, that QA and regulatory teams at any future contract or collaborative site would need to build their quality systems around ahead of a Phase 3 IND submission.
Source: Elicio Therapeutics via GlobeNewswire, May 11, 2026.
