Elicio Therapeutics Announces Q2 2024 Financials and Corporate Updates

Elicio Therapeutics, Inc. reported significant progress in its ongoing clinical programs and financial performance for the second quarter of 2024. The company, a clinical-stage biotechnology firm, focuses on developing novel immunotherapies to treat cancer, including the ELI-002 7P which targets mKRAS-driven solid tumors.

In the second quarter, Elicio shared preliminary data from its AMPLIFY-7P Phase 1 trial, demonstrating a strong correlation between T cell response and reduced risk of disease progression or death. This data was presented at the American Society of Clinical Oncology (ASCO), showing that 100% of patients developed mKRAS-specific T-cell responses with about two-thirds exhibiting responses in both CD4+ and CD8+ T cells. Based on these promising results, Elicio plans to continue with the Phase 2 randomized clinical trial, aiming to complete patient enrollment by the end of 2024.

The company also announced the termination of long-term follow-up in the AMPLIFY-201 Phase 1 study and minimization of follow-up in the AMPLIFY-7P Phase 1 study to focus resources on overall survival data. Updated results from these studies will be shared at upcoming medical conferences.

Financially, Elicio raised $43 million in 2024, which is expected to fund its operations into the second quarter of 2025. This funding will support the continued development of ELI-002 7P, among other initiatives. For the second quarter of 2024, Elicio reported research and development expenses of $8.2 million, a significant increase from $4.9 million in the same period last year, mainly due to costs associated with the AMPLIFY-7P trials. General and administrative expenses remained steady at $2.7 million. The net loss for the quarter was $7.2 million, down from $7.6 million in the second quarter of 2023.

By the end of June 2024, Elicio had $3.4 million in cash and cash equivalents, a decrease from $12.9 million at the end of December 2023. However, this figure does not include the $9.9 million proceeds from a public offering received in July 2024 and $19.7 million from convertible note financing received in August 2024.

Robert Connelly, CEO of Elicio, expressed optimism about the progress in the AMPLIFY-7P program and the robust enrollment in Phase 2 trials. He highlighted that the recent financing provides a runway into mid-2025, coinciding with the expected interim analysis of the Phase 2 trial.

Christopher Haqq, Chief Medical Officer, added that the data from the 7-peptide ELI-002 Phase 1 trial show that the formulation is well-tolerated and generates a more substantial T cell response than the 2-peptide version. The data cutoff on May 24, 2024, indicated that patients on the recommended Phase 2 dose had not yet reached median disease-free survival. He emphasized the potential of targeting mutant KRAS using ELI-002 and expressed eagerness to demonstrate its efficacy in late-phase trials.

Elicio's technology platform, the Amphiphile (AMP) platform, targets the lymph nodes to optimally activate the immune system against cancer. The platform, developed at MIT, aims to improve the magnitude, potency, quality, and durability of the immune response. ELI-002, part of this platform, targets seven common KRAS mutations, potentially increasing the number of patients eligible for treatment and reducing resistance mechanisms.

Looking ahead, Elicio plans to provide updated immunogenicity and relapse-free survival data for the AMPLIFY-201 trial by the end of 2024 and preliminary disease-free survival data from the Phase 1a arm of the AMPLIFY-7P trial in early 2025. The Phase 2 trial's interim analysis is also expected in the first quarter of 2025.

Elicio's advancements in immunotherapy, supported by robust clinical data and financial stability, position it well to continue its innovative work in cancer treatment.