Core Viewpoint - Elicio Therapeutics, a clinical-stage biotechnology company, has announced an underwritten public offering of approximately $11.5 million to advance its cancer immunotherapy pipeline and for general corporate purposes [1][2]. Group 1: Offering Details - The offering includes 500,000 shares of common stock and accompanying common warrants to purchase up to 500,000 shares at a price of $5.00 per share [8]. - Additionally, pre-funded warrants to purchase up to 1,800,000 shares of common stock at an exercise price of $0.01 are being offered, with a combined public offering price of $4.99 per pre-funded warrant [8]. - The offering is expected to close on or about July 1, 2024, subject to customary closing conditions [8]. Group 2: Use of Proceeds - The net proceeds from the offering will be used alongside existing cash and marketable securities to advance Elicio's development pipeline, working capital, and general corporate purposes [2]. Group 3: Company Overview - Elicio Therapeutics focuses on developing novel lymph node-targeted immunotherapies for aggressive cancers, utilizing AMP technology to enhance the immune response [11]. - The company's R&D pipeline includes therapeutic cancer vaccines targeting mKRAS-driven cancers (ELI-002) and BRAF-driven cancers and p53 hotspot mutations (ELI-007 and ELI-008) [11].

Core Viewpoint - Elicio Therapeutics has initiated an underwritten public offering of its common stock and accompanying warrants to support its development pipeline and general corporate purposes [7]. Company Overview - Elicio Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel immunotherapies for aggressive cancers, utilizing AMP technology to enhance immune responses [9]. - The company's R&D pipeline includes therapeutic cancer vaccines targeting mKRAS-driven cancers (ELI-002) and BRAF-driven cancers and p53 hotspot mutations (ELI-007 and ELI-008) [9]. Offering Details - The public offering includes common stock, pre-funded warrants, and accompanying common warrants, with all securities being offered by Elicio [7]. - A shelf registration statement for these securities was filed with the SEC and became effective on June 11, 2024 [8]. - The offering is subject to market conditions, and there is no assurance regarding its completion or the terms of the offering [7][8]. Use of Proceeds - The net proceeds from the offering will be used for advancing the development pipeline, working capital, and general corporate purposes [1].

Core Viewpoint - Elicio Therapeutics, Inc. has initiated an underwritten public offering of its common stock and accompanying warrants, with the offering subject to market conditions and no assurance of completion or specific terms [1][2]. Company Overview - Elicio Therapeutics is a clinical-stage biotechnology company focused on developing novel immunotherapies for cancer treatment, utilizing its AMP technology to enhance the immune system's response against tumors [10]. - The company's R&D pipeline includes therapeutic cancer vaccines such as ELI-002, targeting mKRAS-driven cancers, and ELI-007 and ELI-008, targeting BRAF-driven cancers and p53 hotspot mutations, respectively [10]. Offering Details - A shelf registration statement for the securities has been filed with the SEC, effective June 11, 2024, with a preliminary prospectus supplement to be made available [2]. - JonesTrading Institutional Services LLC is acting as the sole book-running manager for the offering [4]. Use of Proceeds - The net proceeds from the offering, along with existing cash and marketable securities, will be used to advance the development pipeline, working capital, and general corporate purposes [8].

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 ...