Business Overview and Company History
Elicio Therapeutics, Inc. (ELTX) is a clinical-stage biotechnology company pioneering the development of innovative immunotherapies for patients with limited treatment options and poor outcomes in cancer and infectious disease. The company's proprietary Amphiphile (AMP) technology is designed to preferentially target the lymph nodes, aiming to generate a robust T-cell response that can potentially provide meaningful clinical benefit.
Elicio Therapeutics was incorporated in Delaware as Vedantra Pharmaceuticals Inc. in August 2011. In December 2018, the company formed a wholly-owned subsidiary, Elicio Securities Corporation, a Massachusetts-based investment company. On January 17, 2023, Elicio entered into a definitive merger agreement with Angion Biomedica Corp., a clinical-stage biotechnology company. The merger was completed on June 1, 2023, with Elicio becoming a wholly-owned subsidiary of the combined company, which was renamed Elicio Therapeutics, Inc.
Following the merger, Elicio Operating Company and Elicio Australia Pty Ltd. became wholly-owned subsidiaries of the combined company. Immediately after the merger, former Elicio equity holders collectively owned approximately 65.2% of the combined company on a fully diluted basis. The merger was accounted for as a reverse recapitalization, with Elicio Operating Company being treated as the acquirer for accounting purposes. As a result, the net assets of Angion were recorded at their acquisition-date fair value, which approximated book value, in the financial statements of Elicio Operating Company, and the reported operating results prior to the merger were those of Elicio Operating Company.
Elicio's lead programs focus on its cancer vaccine product candidates, which target biologically validated tumor mutation drivers using known neoantigens. This strategy results in an off-the-shelf therapeutic option, allowing patients to receive treatment without delay due to manufacturing timelines and costs associated with personalized vaccine approaches. The company's clinical and preclinical pipeline includes the lymph node-targeted therapeutic cancer vaccines ELI-200, ELI-700, and ELI-800, which are designed to stimulate an immune response against mutant KRAS, BRAF, and TP53, respectively.
Financial Overview
Elicio's operations to date have been primarily financed by aggregate net proceeds of $182.7 million from the issuance of common stock, pre-funded warrants, convertible preferred stock, convertible notes, the exercise of stock options and common stock warrants, private placements, at-the-market offerings, and proceeds from the merger. As of September 30, 2024, the company had $26.0 million in cash and cash equivalents and an accumulated deficit of $180.1 million.
For the nine months ended September 30, 2024, Elicio reported a net loss of $37.9 million, compared to a net loss of $26.2 million for the same period in 2023. Research and development expenses increased to $22.9 million from $17.7 million, primarily due to an increase in external costs associated with the ELI-200 manufacturing and clinical trials. General and administrative expenses remained relatively flat at $8.6 million, compared to $8.7 million in the prior-year period.
For the most recent quarter (Q3 2024), Elicio reported no revenue and a quarterly net loss of $18.8 million. The company did not disclose quarterly operating cash flow or free cash flow figures.
As of December 31, 2023, Elicio had a total debt of $6.9 million and stockholders' equity of $11.4 million, resulting in a debt-to-equity ratio of 0.61. The company's current ratio and quick ratio both stood at 3.40 as of the latest reported period.
Liquidity
Elicio's cash position, as of the filing date of the Q3 2024 report, was expected to support operations into the second quarter of 2025. However, the company's losses from operations, negative operating cash flows, and accumulated deficit, as well as the additional capital needed to fund operations for at least twelve months following the issuance of the financial statements, raise substantial doubt about its ability to continue as a going concern. Elicio plans to address this condition through the sale of common stock or other securities in public offerings and/or private placements, debt financings, or through other capital sources, including licensing arrangements, partnerships, and collaborations with other companies or other strategic transactions.
Pipeline and Clinical Development
Elicio's lead product candidate, ELI-200, is a lymph node-targeted therapeutic cancer vaccine designed to stimulate an immune response against mutant KRAS-driven cancers. The company is currently evaluating ELI-200 in a Phase 2 clinical program. In December 2024, Elicio announced the completion of enrollment in the Phase 2 AMPLIFY-7P study, which is evaluating a 7-peptide formulation of ELI-200 (ELI-200 7P) in patients with mutant KRAS-driven pancreatic ductal adenocarcinoma who are at high risk of relapse following surgery. Elicio expects to report a formal interim analysis of disease-free survival from the AMPLIFY-7P study in the first half of 2025.
Additionally, Elicio is advancing its preclinical pipeline, which includes ELI-700, a lymph node-targeted therapeutic cancer vaccine designed to target mutant BRAF-driven cancers, and ELI-800, a lymph node-targeted therapeutic cancer vaccine designed to target mutated TP53-expressing cancers. The company is currently evaluating these product candidates in preclinical studies.
Risks and Challenges
Elicio faces several risks and challenges common to many clinical-stage biotechnology companies, including the inherent uncertainty of drug development, the need for significant additional funding to advance its pipeline, and the competitive landscape in the immuno-oncology space. The company's reliance on the success of its lead candidate, ELI-200, and the potential for delays or setbacks in its clinical trials, could have a material adverse impact on its business and financial condition.
Furthermore, Elicio's ability to raise additional capital and secure partnerships or collaborations will be crucial in supporting its operations and funding its future development efforts. The company's small size and limited resources compared to larger, more established pharmaceutical and biotechnology companies may also pose challenges in terms of execution and competitive positioning.
Conclusion
Elicio Therapeutics is a clinical-stage biotechnology company with a promising pipeline of lymph node-targeted immunotherapies for the treatment of cancer. The company's proprietary AMP technology aims to generate a robust T-cell response, which could potentially provide meaningful clinical benefit for patients with limited treatment options. While Elicio faces the typical risks and challenges associated with drug development, its focus on biologically validated targets and off-the-shelf therapeutic approach could differentiate it in the competitive immuno-oncology landscape. The company's ability to navigate the regulatory and funding environment will be critical to the successful advancement of its pipeline and the realization of its long-term growth potential.
Elicio Therapeutics primarily operates in the United States and does not disclose performance by geographic markets. The company has not been involved in any major scandals, short seller reports, or CEO departures based on the available information. As a clinical-stage biotechnology company, Elicio's future success largely depends on the clinical progress of its pipeline candidates and its ability to secure additional funding to support ongoing operations and research and development activities.