Elicio Therapeutics Q1 2024 Financial Results and Corporate Updates

Elicio Therapeutics, Inc., a clinical-stage biotechnology company, recently announced its financial results for the first quarter ending March 31, 2024, and provided updates on its corporate and clinical progress. The company, which is traded on Nasdaq under the ticker ELTX, focuses on developing innovative immunotherapies for treating cancer.

During the first quarter, Elicio achieved significant milestones with its lead program, ELI-002. The company published the first-in-human Phase 1 data for the ELI-002 2P formulation in Nature Medicine and commenced patient enrollment for the randomized Phase 2 trial of the ELI-002 7P formulation. Elicio's CEO, Robert Connelly, highlighted the anticipation of presenting preliminary data from the ELI-002 7P Phase 1 cohort at the upcoming ASCO Annual Meeting in June 2024, with the goal of completing enrollment for the Phase 2 cohort by the end of 2024.

Christopher Haqq, M.D., Ph.D., Elicio's EVP and Chief Medical Officer, emphasized the robust and differentiated T cell response generated by ELI-002. The data presented at the AACR Annual Meeting demonstrated that ELI-002's mechanism of action includes antigen spreading, enhancing clinical activity by targeting personal neoantigens alongside KRAS-specific responses.

Corporate Updates:

AMPLIFY-201 Trial: This multicenter Phase 1 trial assesses the safety, immunogenicity, and antitumor activity of ELI-002 2P monotherapy in patients with mutant KRAS-driven solid tumors at high risk of relapse following standard surgery and chemotherapy. Key findings from the first-in-human study of ELI-002 2P include durable immunogenicity in patients with high relapse-risk mKRAS-driven colorectal cancer and pancreatic ductal adenocarcinoma. Many patients who received ELI-002 booster immunizations maintained or increased mKRAS-specific T cell responses, with no safety concerns or dose-limiting toxicities observed.

AMPLIFY-7P Trial: This multicenter Phase 1/2 trial evaluates ELI-002 7P in patients with high-relapse-risk mutant KRAS-driven solid tumors. The 7P formulation aims to provide immune response coverage against seven common KRAS mutations, potentially reducing bypass resistance mechanisms. Preliminary data from the Phase 1a trial will be presented at ASCO in June 2024, with Phase 2 trial enrollment initiated in January 2024.

Upcoming Milestones:

- June 2024: Presentation of preliminary data on ELI-002 7P monotherapy from the Phase 1a arm at ASCO.
- Q4 2024: Completion of enrollment in the randomized Phase 2 trial of AMPLIFY-7P, with an interim analysis expected in Q1 2025.
- Q4 2024: Provision of updated immunogenicity and relapse-free survival data from the AMPLIFY-201 trial.

First Quarter 2024 Financial Results:

Elicio reported a rise in research and development (R&D) expenses to $7.6 million, up from $5.5 million in Q1 2023, mainly due to increased clinical trial expenses. General and administrative (G&A) expenses also increased to $2.7 million from $2.3 million in the same period. The net loss for Q1 2024 was $11.8 million, compared to $8.0 million in Q1 2023. As of March 31, 2024, the company's cash and cash equivalents stood at $11.9 million.

About ELI-002:

ELI-002 is a novel investigational cancer vaccine targeting mKRAS-driven cancers. It utilizes Amphiphile (AMP) technology, combining AMP-modified mutant KRAS peptide antigens with an AMP-modified CpG adjuvant. ELI-002 2P is being tested in a Phase 1 trial for high-relapse-risk mKRAS-driven tumors, while ELI-002 7P is in a Phase 1/2 trial for mKRAS-driven pancreatic cancer. The 7P formulation targets seven common KRAS mutations, potentially expanding the patient population.

About Elicio Therapeutics:

Elicio Therapeutics focuses on developing lymph node-targeted immunotherapies to treat aggressive cancers. The company's AMP technology aims to enhance the immune system's ability to fight cancer by delivering therapeutic payloads directly to the lymph nodes. Elicio's pipeline includes off-the-shelf cancer vaccines like ELI-002, ELI-007, and ELI-008, which target various cancer mutations.

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