Elicio Therapeutics reports 2023 financial results and provides company update

• ELI-002 2P clinical immunogenicity data accepted for poster presentation at the 2024 AACR Annual Meeting

• Preclinical data for ELI-007 and ELI-008 are Selected for poster presentation at the 2024 AACR Annual Meeting

• Phase 2 randomized trial in PDAC is underway and enrollment is expected to be completed in the fourth quarter of 2024

• Initial clinical trial data for ELI-002 7P is expected in the second quarter of 2024

• Private placement with gross proceeds of $6 million to be completed in March 2024

BOSTON, March 29, 2024 (GLOBE NEWSWIRE) — Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elysio Therapeutics” or “Elysio”) is developing a pipeline of novel immunotherapies for the treatment of cancer. A clinical-stage biotechnology company developing Today, we reported our financial results for the year ended December 31, 2023 and provided recent business highlights.

“2023 was a significant year for Elisio, with the successful completion of the reverse merger, publication of first-in-human clinical data, and the launch of ELI-002,” said Robert Connelly, CEO of Elisio. has been advanced to a randomized phase 2 trial.” “Already in 2024, we are building on our progress in 2023 by publishing Phase 1a clinical data in Nature Medicine and announcing that the first patient was administered in a randomized Phase 2 trial. The company remains focused on developing its lead cancer vaccine candidate, ELI-002, and advancing its randomized Phase 2 trial as monotherapy in patients with PDAC. It’s going to be an exciting year ahead as we look forward to sharing data from the AMPLIFY-7P Phase 1 study of ELI-002 7P.”

Latest company information

AMPLIFY-7P Phase 1a:

• Enrollment of 14 patients was completed in the third quarter of 2023, and initial clinical data for ELI-002 7P is expected in the second quarter of 2024.

• An independent data monitoring board completed a safety review of ELI-002 7P's Phase 1 study patients and confirmed the recommended Phase 2 study dose.

AMPLIFY-7P Phase 2:

• First patient administered in randomized Phase 2 trial of ELI-002 7P, an investigational cancer therapeutic vaccine administered as adjuvant monotherapy to patients with KRAS-mutated pancreatic ductal adenocarcinoma (“PDAC”) .

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AMPLIFY-201 Phase 1a:

Financial results for fiscal year 2023

R&D expenses were $23.8 million in 2023, compared to $18.1 million in 2022. The increase in R&D expenses was primarily due to Elisio's initiation of AMPLIFY-7P Phase 1a research and ongoing product delivery. This was due to an increase in manufacturing and clinical trial costs as we generated clinical trial products. Phase 2 trial.

General and administrative expenses were $11.9 million in 2023, compared to $5.6 million in 2022. The increase in general and administrative expenses was primarily due to professional fees, personnel costs and insurance associated with operating as a public company. did.

Net loss in 2023 was $35.2 million compared to $28.2 million in 2022. Net loss per share in 2023 was $6.96 compared to $89.27 in 2022. The decrease in net loss per share was primarily due to an increase in the weighted average number of common shares outstanding. As a result of the June 2023 reverse merger with Angion Biomedica Corp.;

Cash and cash equivalents at December 31, 2022 were $6.2 million compared to $12.9 million at December 31, 2023.

About Elysio Therapeutics

Elicio Therapeutics is a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer. Combining expertise in immunology and immunotherapy, Elysio is an investigational amphipathic drug that aims to precisely target and fully engage the lymph nodes, the site in the body where the immune response is regulated. Developing substance (“AMP”) immunotherapy. Elysio develops lymph node-targeted AMPlifiers, immunomodulators, adjuvants, and vaccines for a range of aggressive cancers.

About the Amphiphile Platform

Our proprietary Amphophile (“AMP”) platform delivers investigational immunotherapy drugs directly to the lymph nodes, the “brain center” of the immune system. We believe that this site-specific delivery of disease-specific antigens, adjuvants, and other immunomodulators efficiently educates, activates, and amplifies critical immune cells, providing powerful adaptations needed for the treatment of many diseases. We believe that it has the potential to induce and sustain immunity. In preclinical models, we observed that lymph node-specific involvement promoted therapeutic immune responses of increased magnitude, function, and durability. Based on preclinical studies, we believe that AMP lymph node-targeted approaches yield superior clinical benefits compared to non-lymph node-targeted immunotherapies.

Our AMP platform, originally developed at the Massachusetts Institute of Technology, has broad potential to advance many development initiatives in the cancer field, whether through internal activities, implementation agreements, or development collaborations and partnerships.

The AMP platform has been shown to deliver immunotherapeutics directly to lymph nodes by capturing the protein albumin present in the bloodstream as it travels to lymphoid tissues. In preclinical models, we observed that lymph node-specific involvement increases the magnitude, function, and durability of the immune response.

Cautionary Note Regarding Forward-Looking Statements

Certain statements contained in this communication regarding matters that are not historical facts are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as PSLRA. . These include statements regarding Elysio's planned clinical programs, including planned clinical trials, the potential of Elysio's product candidates, upcoming conference participation and presentation plans, and management's intentions, plans and beliefs; Contains other statements regarding expectations or projections for the future. Therefore, be careful not to rely too much on them. Forward-looking statements cannot be guaranteed and actual results may differ materially from those projected. Elisio undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law. We use the words “anticipate,” “believe,” “plan,” “expect,” “plan,” “future,” “intend,” “may,” “will,” ” To identify these forward-looking statements that are subject to the safe harbor provisions of the PSLRA, we use the following terms: ”, and similar expressions are used. Such forward-looking statements are based on our expectations and involve risks and uncertainties. Accordingly, actual results may differ from those expressed or implied in the statements due to a number of factors, including, but not limited to, Elicio's financial condition, including its ability to obtain the necessary financing to proceed with the development of ELI-002. It can vary greatly. other future product candidates and Elisio's ability to continue as a going concern; Elicio plans to develop and commercialize product candidates, including ELI-002. the timing of the start of Elysio's planned clinical trials; This includes Elysio expected to complete enrollment in PDAC's Phase 2 randomized trial in the fourth quarter of 2024. the timing of data availability from Elysio's clinical trials, including data from his AMPLIFY-7P Phase 1 trial of ELI-002 7P, scheduled for Q2 2024; the timing of planned investigational new drug applications or new drug applications; Elicio's plans to research, develop and commercialize its current and future product candidates; Elisio's ability to successfully collaborate with existing collaborators or enter into new collaborations and to perform its obligations under such collaboration agreements; the clinical utility, potential benefits and market acceptance of Elicio's product candidates; Elicio's commercialization, marketing and manufacturing capabilities and strategies; Elysio's ability to identify additional products or product candidates with significant commercial potential; Elysio's ability to advance ELI-002 outside of PDAC monotherapy and Elysio's pipeline programs; developments and forecasts regarding Elicio's competitors and our industry; the effects of government laws and regulations; Elicio's ability to protect its intellectual property rights; Elisio's estimates of future revenues, expenses, capital requirements and need for additional financing;

New factors emerge from time to time, and it is impossible to predict all such factors. Nor can we assess the impact of each such factor on our business or the degree to which any factor, or combination of factors, is likely to be the actual cause. Results may differ materially from those contained in the forward-looking statements. These risks are discussed in our Annual Report on Form 10-K to be filed with the SEC under the heading “Risk Factors” on March 29, 2024, and in other reports filed from time to time thereafter. Discussed in detail in the document. With SEC. The forward-looking statements contained in this release are based on information available to Elicio as of the date of this release. Elicio undertakes no obligation to update such forward-looking statements to reflect events or circumstances after the date of this release, except to the extent required by law.

media contact
Christine Politi
Lifecy Communications
kpoliti@lifescicomms.com
646-876-4783

Investor information contact information
Heather DiVecchia
Elisio Therapeutics
IR@elicio.com
857-209-0153