Elicio Therapeutics, Inc.

Elicio Therapeutics hosted a key opinion leader event to highlight the path forward for its drug candidate, ELI-002 7P, in metastatic mutant KRAS-driven pancreatic ductal adenocarcinoma (mKRAS PDAC). The event showcased promising preliminary clinical data, including 100% confirmed complete radiographic and metabolic responses in three patients who received ELI-002 7P followed by nivolumab-based therapy. These rare and durable responses in a difficult-to-treat patient population support the company's plan to initiate a Phase 1 study evaluating ELI-002 7P in combination with checkpoint inhibition in first-line mPDAC.

Elicio Therapeutics reported preliminary clinical observations from its Phase 2 AMPLIFY-7P study, showing multiple complete responses in patients with metastatic mKRAS pancreatic cancer. Three patients who progressed on ELI-002 7P subsequently achieved 100% confirmed complete radiographic and metabolic responses after receiving nivolumab-based therapy. The company believes these observations support the evaluation of ELI-002 7P in combination with checkpoint inhibition and plans to initiate a Phase 1 study in first-line metastatic mKRAS PDAC, subject to funding. Complete responses are historically rare in this patient population.

Elicio Therapeutics reported preliminary clinical observations showing three metastatic pancreatic cancer patients achieved confirmed complete radiographic and metabolic responses after receiving nivolumab-based therapy following ELI-002 7P treatment. These responses, which are rarely observed in this disease, suggest that ELI-002 7P-induced immune responses may enhance sensitivity to checkpoint inhibition. The company plans to initiate a Phase 1 study in first-line metastatic mKRAS PDAC to prospectively evaluate ELI-002 7P in combination with checkpoint inhibition and standard chemotherapy, subject to funding. This study aims to rapidly assess clinical activity and inform future development strategies, including a Phase 3 trial.

Elicio Therapeutics announced results from its Phase 2 AMPLIFY-7P study for ELI-002 7P in adjuvant pancreatic cancer. While the study did not meet its primary disease-free survival endpoint in the overall population, post-hoc analyses revealed a stronger treatment effect in R0 resected patients and a correlation between T cell responses and improved DFS. The company is refining its Phase 3 strategy to focus on R0 patients with extended dosing and is exploring financing and partnership opportunities. Elicio anticipates its current cash will fund operations through Q4 2026.

Elicio Therapeutics announced that its randomized Phase 2 AMPLIFY-7P study for ELI-002 7P in mKRAS-driven pancreatic cancer did not meet its pre-specified primary endpoint of disease-free survival (DFS) in the intent-to-treat population. However, post-hoc analysis identified a stronger DFS hazard ratio (HR 0.65, p=0.048) in the R0, completely resected patient population, which represents 84% of the study participants. This subgroup showed a median DFS of 23.8 months vs. 12.8 months for observation. The company plans a refined Phase 3 development strategy focusing on R0 resected patients with additional dosing, and is evaluating financing and partnering opportunities to support future clinical development, with current cash expected to last into Q4 2026.

Elicio Therapeutics announced the publication of a peer-reviewed manuscript in Science Advances, detailing novel lymph node-targeting AMP-DNA adjuvant candidates. The preclinical data highlights the platform's ability to drive robust, durable immune responses through targeted delivery and activation of innate immune pathways, expanding beyond their initial clinical programs. This work reinforces the versatility of Elicio's AMP platform for developing next-generation immunotherapies across oncology and infectious disease.

Elicio Therapeutics reported an increased net loss of $(11.8) million for the first quarter of 2026, compared to $(11.2) million in the prior year. The company's cash and cash equivalents significantly decreased to $14.9 million, and it recorded a total stockholders' deficit of $(1.4) million. These financial conditions, coupled with ongoing operating losses, led management to express substantial doubt about the company's ability to continue as a going concern, despite raising $8.0 million through at-the-market equity programs during the quarter.

Elicio Therapeutics reported a Q1 2026 net loss of $(11.8) million, with net loss per share improving to $(0.65). The company anticipates the event-driven primary disease-free survival analysis for its Phase 2 AMPLIFY-7P study in pancreatic cancer mid-year 2026, noting fewer disease progressions and deaths than projected to date. Elicio raised $13.0 million through its at-the-market program, extending its cash runway into Q4 2026, beyond the expected DFS data readout.

Elicio Therapeutics, Inc. filed an Amendment No. 1 on Form 10-K/A to its Annual Report for the fiscal year ended December 31, 2025. The amendment primarily includes information required by Part III, detailing the company's directors, executive officers, and corporate governance practices, which was intentionally omitted from the original filing. It also updates the exhibit list and includes new certifications. The company's market value of non-affiliate voting stock was approximately $81.8 million as of June 30, 2025.

Elicio Therapeutics, Inc. filed an Amendment No. 1 on Form 10-K/A to its Annual Report for the fiscal year ended December 31, 2025. The amendment includes information required by Part III, which covers directors, executive officers, and corporate governance, and updates the exhibit list in Part IV with new certifications. The filing also disclosed an aggregate market value of voting stock held by non-affiliates of approximately $81.8 million as of June 30, 2025, and 18,704,798 shares outstanding as of April 9, 2026.