Core Insights - Elicio Therapeutics is advancing its investigational cancer vaccine ELI-002 7P, targeting mKRAS-driven solid tumors, with preliminary data from the AMPLIFY-7P Phase 1a study showing promising early results in disease-free survival (DFS) [1][5][6] - The study involved 14 patients, with a median follow-up of 29.1 weeks, indicating a correlation between strong T cell responses and reduced tumor biomarker levels, suggesting potential efficacy of ELI-002 [1][6] - ELI-002 is designed to target seven common KRAS mutations, potentially expanding the patient population for treatment [7][8] Study Details - The AMPLIFY-7P study is evaluating the 7-peptide formulation of ELI-002 in patients with minimal residual disease after standard treatment [1] - As of the May 24, 2024 data cutoff, the median DFS has not yet been reached for patients receiving the 4.9mg AMP-peptide dose, while those receiving the 1.4mg dose had a median DFS of 12.6 weeks [6] - Patients with a reduction in tumor biomarker levels showed no progression events, contrasting with a median DFS of 11.0 weeks for those without such a response [6] Company Overview - Elicio Therapeutics is a clinical-stage biotechnology company focused on developing novel immunotherapies for cancer treatment, utilizing its AMP technology to enhance immune responses [8] - The company's pipeline includes ELI-002, targeting mKRAS-driven cancers, as well as other candidates targeting BRAF-driven cancers and p53 hotspot mutations [8]

Core Insights - Elicio Therapeutics is a clinical-stage biotechnology company focused on developing lymph node-targeted immunotherapies for aggressive cancers, utilizing AMP technology to enhance immune responses against tumors [4][7]. Company Overview - Elicio Therapeutics, Inc. (Nasdaq: ELTX) is advancing a pipeline of novel immunotherapies aimed at treating aggressive cancers by leveraging the immune system's natural capabilities [4]. - The company’s AMP technology allows for direct delivery of therapeutic payloads to lymph nodes, optimizing the immune response to cancer [4]. Product Pipeline - The R&D pipeline includes ELI-002, targeting mKRAS-driven cancers, and ELI-007 and ELI-008, which target BRAF-driven cancers and p53 hotspot mutations, respectively [4]. - ELI-002 is a novel investigational cancer vaccine designed to target mutations in the mKRAS gene, a common driver in many cancers [6][11]. Clinical Trials - The AMPLIFY-7P study is currently evaluating the 7-peptide formulation of ELI-002 in patients with mKRAS-driven solid tumors, with preliminary data showing promising results in disease-free survival (DFS) [6][7]. - As of the May 24, 2024 data cutoff, the median DFS has not yet been reached for patients receiving the 4.9mg AMP-peptide dose, while patients with a strong T cell response showed no progression events [8]. Data Highlights - In the AMPLIFY-7P study, patients receiving the 4.9mg dose have not reached the median DFS endpoint, contrasting with a median DFS of 12.6 weeks for those receiving a lower dose [8]. - Patients with reduced tumor biomarker levels experienced no progression events, indicating a correlation between T cell response and tumor reduction [8].

Core Insights - Elicio Therapeutics, Inc. has granted 5,400 inducement stock options to two new employees as part of their employment agreement, in compliance with Nasdaq Listing Rule 5635(c)(4) [1] - The stock options were approved by the Compensation Committee and are part of the 2024 Inducement Incentive Award Plan [1] - The stock options will vest over four years, with 25% vesting on the first anniversary of each employee's start date and the remainder vesting monthly thereafter, contingent on continued service [6] Company Overview - Elicio Therapeutics is a clinical-stage biotechnology company focused on developing novel immunotherapies for cancer treatment [13] - The company utilizes AMP technology to deliver therapeutic payloads directly to lymph nodes, enhancing the immune system's ability to fight cancer [13] - Elicio's lead product candidate, ELI-002, targets mKRAS-driven cancers and is currently in clinical trials [12][7] Product Pipeline - ELI-002 is being studied in two ongoing clinical trials: AMPLIFY-201 for high relapse risk mKRAS-driven solid tumors and AMPLIFY-7P for mKRAS-driven pancreatic cancer [7] - The ELI-002 7P formulation aims to provide immune response coverage against seven common KRAS mutations, potentially increasing the patient population [7]

Core Insights - Elicio Therapeutics is a clinical-stage biotechnology company focused on developing novel immunotherapies for cancer treatment, with a specific emphasis on targeting mKRAS-driven cancers [7][12] - The company has granted 5,400 inducement stock options to two new employees as part of its 2024 Inducement Incentive Award Plan, approved by the Compensation Committee [7] - Elicio's lead product candidate, ELI-002, is an investigational cancer vaccine designed to target mutations in the mKRAS gene, which is prevalent in many human cancers [8][12] Company Overview - Elicio Therapeutics is advancing a pipeline of lymph node-targeted immunotherapies, utilizing AMP technology to enhance the immune system's ability to fight cancer [12] - The company's R&D pipeline includes ELI-002, targeting mKRAS-driven cancers, as well as ELI-007 and ELI-008, which target BRAF-driven cancers and p53 hotspot mutations, respectively [12] Product Development - ELI-002 is currently being studied in two clinical trials: the Phase 1 AMPLIFY-201 trial for high relapse risk mKRAS-driven solid tumors and the Phase 1/2 AMPLIFY-7P trial for mKRAS-driven pancreatic cancer [9] - The ELI-002 7P formulation aims to provide immune response coverage against seven common KRAS mutations, potentially increasing the patient population eligible for treatment [9] Stock Options - The inducement stock options granted to new employees allow for the purchase of Elicio common stock at a price of $7.98 per share, reflecting the closing price on the grant date [11]

Core Insights - Elicio Therapeutics announced preliminary data from the AMPLIFY-7P Phase 1a study of its investigational cancer vaccine ELI-002 7P, showing it was well tolerated and correlated with tumor biomarker reduction [1][4][6] Study Overview - The AMPLIFY-7P study evaluates ELI-002 7P in patients with mKRAS-driven solid tumors that are positive for minimal residual disease after standard treatment [2][10] - ELI-002 7P utilizes Elicio's proprietary Amphiphile technology to stimulate immune responses against seven KRAS mutations, which are responsible for 25% of all solid tumors [2][9] Preliminary Results - ELI-002 7P generated a ~100x mKRAS-specific T cell response compared to baseline levels, with 100% of patients showing mKRAS-specific T cell responses [6][7] - At the recommended Phase 2 dose of 4.9 mg, tumor biomarker reductions were observed in 71% of evaluable patients [6][7] - Antigen-spreading was noted, with increased T cell responses targeting non-immunizing personalized tumor neoantigens in 100% of evaluable patients at the 4.9 mg dose level [6][13] Expert Commentary - Experts expressed encouragement regarding the favorable safety profile and early antitumor effects of ELI-002 7P, highlighting its potential to provide broader coverage for patients with KRAS mutations [3][4] Presentation Details - The findings will be presented at the ASCO Annual Meeting on June 1, 2024, with the abstract titled "AMPLIFY-7P, a first-in-human safety and efficacy trial of adjuvant mKRAS-specific lymph node targeted amphiphile ELI-002 7P vaccine" [5]

Financial Performance - Net loss for the three months ended March 31, 2024, was $11,827,000 compared to a net loss of $8,029,000 for the same period in 2023, representing a 47.5% increase in losses[23]. - The company reported a comprehensive loss of $11,900,000 for the three months ended March 31, 2024, compared to a comprehensive loss of $8,029,000 for the same period in 2023, indicating a 48.5% increase in comprehensive losses[23]. - The net loss for the three months ended March 31, 2024, was $11.8 million, compared to a net loss of $8.0 million for the same period in 2023, reflecting an increase of $3.8 million[163]. - Other income (expense), net for the three months ended March 31, 2024, was an expense of $1.6 million, compared to an expense of $0.2 million for the same period in 2023, primarily due to changes in fair value associated with Pre-Funded Warrants[162]. Assets and Liabilities - Total current assets decreased from $16,348,000 as of December 31, 2023, to $14,130,000 as of March 31, 2024, a decline of approximately 13.5%[21]. - Total liabilities increased from $15,773,000 as of December 31, 2023, to $19,610,000 as of March 31, 2024, an increase of approximately 24.5%[21]. - Total stockholders' equity decreased from $11,373,000 as of December 31, 2023, to $4,870,000 as of March 31, 2024, a decline of approximately 57.3%[21]. - As of March 31, 2024, the company had total assets of $6,363,000, which included money market funds[80]. - The company’s total liabilities were $7,868,000, with warrant liabilities accounting for $7,868,000 as of March 31, 2024[80]. Cash Flow - The company reported a net cash used in operating activities of $12,122,000 for the three months ended March 31, 2024, compared to $8,139,000 for the same period in 2023, reflecting a 49.0% increase in cash outflows[30]. - For the three months ended March 31, 2024, net cash used in operating activities was $12.1 million, consisting of a net loss of $11.8 million and changes in assets and liabilities of $2.8 million, partially offset by non-cash charges of $2.5 million[166]. - Net cash provided by financing activities for the three months ended March 31, 2024, was $11.0 million, resulting from the issuance of $5.1 million of common stock and $6.0 million of pre-funded warrants[169]. Research and Development - Research and development expenses rose to $7,559,000 for the three months ended March 31, 2024, up from $5,484,000 in the same period of 2023, an increase of approximately 37.8%[23]. - The company incurred $1.4 million in research and development expenses related to the second grant agreement with the GI Research Foundation for the three months ended March 31, 2024[91]. - The company anticipates significant increases in research and development expenses as it continues to advance its product candidates and seek regulatory approvals[146]. Stock and Financing - The company issued 615,363 shares of common stock from an At-the-Market offering, raising approximately $5,062,000 after issuance costs[25]. - The company issued and sold a total of 615,363 shares of common stock under the At-the-Market Equity Program for aggregate net sale proceeds of approximately $5.1 million during the three months ended March 31, 2024[97]. - The Company issued 1,032,702 Pre-Funded Warrants in the March Offering at an exercise price of $0.01 per share, resulting in gross proceeds of approximately $6.0 million[132]. Financial Condition and Future Outlook - Elicio expects to incur substantial expenditures for the development of its product candidates and will require additional financing[36]. - The company expects to fund operations into the third quarter of calendar year 2024 based on current cash on hand, but substantial doubt exists about its ability to continue as a going concern[144]. - The company plans to address its financial condition through the sale of common stock, debt financings, and other capital sources, but there is no assurance these plans will be successful[164]. Internal Controls and Compliance - Material weaknesses in internal control over financial reporting were identified, including insufficient resources with knowledge of U.S. GAAP and inadequate financial reporting controls[190]. - Remediation efforts for identified material weaknesses include engaging consultants and hiring additional finance personnel, but these weaknesses have not been fully remediated as of March 31, 2024[192]. - The effectiveness of internal control over financial reporting is subject to inherent limitations, which may affect the reliability of financial statements[193]. Legal and Regulatory Matters - The company was involved in legal proceedings that could result in substantial costs, including indemnification of directors and officers[195]. - There have been no material changes in the company's risk factors from those described in the Form 10-K[197].

BOSTON, April 25, 2024 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (NASDAQ:ELTX, "Elicio Therapeutics" or "Elicio"))), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced that it will be sharing new preliminary data from the ongoing AMPLIFY-7P Phase 1/2 study in a poster presentation at the 2024 American Society of Clinical Oncology ("ASCO") Annual Meeting, being held May 31-June 4, 2024 in Chicago, IL. The AMPLIFY-7P study is ...

68% of patients treated with ELI-002 developed cytotoxic mKRAS-specific CD4+ T cells84% of patients treated with ELI-002 developed cytotoxic mKRAS-specific CD8+ T cellsThe majority of ELI-002-treated patients tested had antigen spreading where induced T cells targeted additional patient-specific tumor mutations beyond mKRASThe majority of patients who received a ELI-002 booster dose were observed to have durable mKRAS-specific T cell response with increased memory T cell phenotype Preclinical studies of ELI ...

68% of patients treated with ELI-002 developed cytotoxic mKRAS-specific CD4+ T cells84% of patients treated with ELI-002 developed cytotoxic mKRAS-specific CD8+ T cellsThe majority of ELI-002-treated patients tested had antigen spreading where induced T cells targeted additional patient-specific tumor mutations beyond mKRASThe majority of patients who received a ELI-002 booster dose were observed to have durable mKRAS-specific T cell response with increased memory T cell phenotype Preclinical studies of ELI ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Elicio Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 11-3430072 (I.R.S. Employer Identification No.) Washington, D.C. 20549 _____________________________________________ FORM 10-K _____________________________________________ ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 ...