KRAS mutant pancreatic ductal adenocarcinoma

Two original papers in Nature highlight the discovery and translational implications of RMC-7977, a RAS(ON) multi-selective tri-complex inhibitor that exhibits unprecedented anti-tumor activity in preclinical models of RAS-mutant pancreatic ductal adenocarcinoma (PDAC) First paper demonstrates RMC-7977 successfully targets signaling by both mutant and wild-type forms of RAS to drive potent and durable inhibition of RAS-mutated cancers Second paper highlights translation-focused research with RMC-7977, which drives deep and durable anti-tumor activity, at well-tolerated doses, across a wide range of RAS-mutated PDAC preclinical models REDWOOD CITY, Calif., April 08, 2024 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced the publication of two peer-reviewed research papers in Nature. The first paper highlights the discovery and preclinical characterization of RMC-7977, a preclinical tool compound representative of a class of oral RAS(ON) multi-selective inhibitors, including the investigational drug candidate RMC-6236, that target multiple RAS variants. The second paper highlights the systematic evaluation of RMC-7977 in a wide range of preclinical models of PDAC. This original research was led by scientists at Revolution Medicines and conducted in collaboration with researchers from across the U.S. and Europe. Oncogenic RAS proteins drive up to 30 percent of all human cancers, most notably non-small cell lung cancer (NSCLC), PDAC and colorectal cancer (CRC). RAS G12 mutations, such as G12D, G12V and G12C, predominate in human cancers. Approved KRAS-targeted cancer therapies target only one particular RAS mutation, KRAS G12C. The first Nature paper describes RMC-7977, a RAS(ON) multi-selective inhibitor preclinical tool compound, which was designed to inhibit the full spectrum of oncogenic RAS mutations, including RAS codon 12 mutations (RAS G12X) as well as non-mutated wild-type RAS. RMC-7977 engages the intracellular chaperone cyclophilin A (CYPA) to form a binary complex that binds reversibly and with high affinity to RAS proteins that are in the active, GTP-bound or ON state. In preclinical studies, RMC-7977 demonstrated robust, durable anti-tumor activity at well-tolerated doses across a range of RAS-mutated NSCLC, PDAC and CRC models. Importantly, the preclinical study demonstrated that RAS(ON) multi-selective inhibitors, as represented by RMC-7977, have the potential to overcome some of the resistance mechanisms that have been shown to limit the clinical efficacy and durability of current KRAS(OFF) G12C-selective inhibitors, including adaptive signaling mechanisms mediated by activation of wild-type RAS. The second report describes research into the pharmacology and anti-tumor activity of the tool compound, RMC-7977, which was evaluated across a diverse range of preclinical PDAC models. Broad and pronounced anti-tumor activity was observed across various preclinical models following direct RAS inhibition by RMC-7977 at exposures that were well tolerated in vivo, providing a strong preclinical rationale for evaluating broad-spectrum RAS inhibition in the clinical PDAC setting. Furthermore, careful analysis of recognized clinical resistance mechanisms in a sophisticated model of PDAC treated with RMC-7977 revealed a promising combination treatment regimen that may be capable of countering monotherapy drug resistance. “This innovative research extends the impact of our tri-complex inhibitor platform to a wide range of common, oncogenic RAS mutants for which no targeted drugs are available, and supported the discovery of RMC-6236, our clinical-stage RAS(ON) multi-selective inhibitor. The findings reverse long-standing scientific dogma by showing that it is possible to obtain meaningful anti-tumor activity by broadly targeting the RAS class of proteins without unacceptable effects in normal tissues,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “The preclinical findings reported in these scientific papers, combined with initial data we have disclosed from an ongoing clinical study of RMC-6236, support further evaluation of RMC-6236 in patients living with RAS-addicted cancers, for whom there remain large unmet medical needs.” The investigational oral drug candidate RMC-6236 is a RAS(ON) multi-selective inhibitor designed to treat patients with cancers driven by a wide range of common RAS mutations. Revolution Medicines is currently evaluating RMC-6236 as monotherapy in a first-in-human trial in patients with advanced solid tumors harboring G12X, G13X, and Q61X mutations (NCT05379985). Based on promising preliminary data in this trial, planning is underway to initiate pivotal studies of RMC-6236 as monotherapy in NSCLC and PDAC. RMC-6236 is also being evaluated in combination with pembrolizumab with or without chemotherapy in patients with advanced RAS-mutated solid tumors (NCT06162221) and in combination with RMC-6291, the company’s investigational RAS(ON) G12C-selective inhibitor, for patients with advanced KRAS G12C-mutated solid tumors (NCT06128551). The scientific papers published in Nature can be accessed at the following links: “Concurrent inhibition of oncogenic and wild-type RAS-GTP for cancer therapy”“Tumor-selective effects of active RAS inhibition in pancreatic ductal adenocarcinoma” About Revolution Medicines, Inc.Revolution Medicines is a clinical-stage oncology company developing novel targeted therapies for RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS companion inhibitors for use in combination treatment strategies. The company’s RAS(ON) inhibitors RMC-6236, a RAS(ON) multi-selective inhibitor, RMC-6291, a RAS(ON) G12C-selective inhibitor, and RMC-9805, a RAS(ON) G12D-selective inhibitor, are currently in clinical development. Additional RAS(ON) mutant-selective inhibitors in the company’s development pipeline include RMC-5127 (G12V), RMC-0708 (Q61H) and RMC-8839 (G13C). Forward Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered "forward-looking statements," including without limitation statements regarding the potential advantages of Revolution Medicines’ preclinical and clinical candidates, including the potential efficacy, durability, tolerability, and combination potential of RMC-7977 and RMC-6236 and their ability to overcome resistance mechanisms; the company’s development plans and its ability to advance its portfolio and R&D pipeline, including the company’s potential evaluation of broad-spectrum RAS inhibition in the clinical PDAC setting and its planned initiation of pivotal studies of RMC-6236 as monotherapy in NSCLC and PDAC; the outcome of the company’s preclinical studies and clinical trials; the potential application of the company’s tri-complex inhibitor platform to a wide range of oncogenic RAS mutations; and the company’s expectations regarding the size of the unmet medical needs its product candidates could address, if approved for commercial use. Forward-looking statements are typically, but not always, identified by the use of words such as "may," "will," "would," "believe," "intend," "plan," "anticipate," "estimate," "expect," and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company’s development programs, future results, performance or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company’s programs’ early stage of development, the process of designing and conducting preclinical studies and clinical trials, risks that the results of prior preclinical models or studies may not be predictive of future clinical trials, clinical efficacy or other future results, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, the risk that the wind-down of EQRx, Inc. could take longer than anticipated or result in unexpected costs, and the effects on the company’s business of global events, such as international conflicts or pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in the forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines’ Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 26, 2024, and its future periodic reports to be filed with the Securities and Exchange Commission. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances, or to reflect the occurrence of unanticipated events.

ELI-002 2P clinical immunogenicity data were accepted for a poster presentation at the AACR Annual Meeting 2024ELI-007 and ELI-008 preclinical data were accepted for a poster presentation at the AACR Annual Meeting 2024Phase 2 randomized trial in PDAC is underway with enrollment expected to complete in the fourth quarter of 2024ELI-002 7P initial clinical trial data expected in the second quarter of 2024Private placement with gross proceeds of $6.0 million closed in March 2024 BOSTON, March 29, 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 reported financial results for the year ending December 31, 2023, and provided recent business highlights. “2023 was a momentous year for Elicio with the completion of a successful reverse merger, presenting clinical data from our first-in-human trial and advancing ELI-002 into a randomized Phase 2 trial,” said Robert Connelly, Elicio’s Chief Executive Officer. “Already in 2024 we have built on 2023’s progress with our Phase 1a clinical data being published in Nature Medicine and announcing the first patients were dosed in the randomized Phase 2 trial. We continue to focus on advancing our lead cancer vaccine candidate, ELI-002, and the progression of our randomized Phase 2 study as a monotherapy for patients with PDAC. We have an exciting year ahead as we expect to share data from the AMPLIFY-7P Phase 1 study of ELI-002 7P in the second quarter.” Corporate Updates AMPLIFY-7P Phase 1a: Completed enrollment of 14 patients in the third quarter of 2023 with initial clinical data for ELI-002 7P expected in the second quarter of 2024.The independent data monitoring committee completed the safety review of ELI-002 7P Phase 1 trial patients and confirmed the recommended Phase 2 trial dose. AMPLIFY-7P Phase 2: First patients dosed in a randomized Phase 2 study of ELI-002 7P, an investigational therapeutic cancer vaccine, administered as an adjuvant monotherapy treatment for patients with KRAS-mutated pancreatic ductal adenocarcinoma (“PDAC”). AMPLIFY-201 Phase 1a: Data from the first-in-human study of ELI-002 2P published in Nature Medicine shows: The data were as of September 6, 2023, based on 25 patients with solid tumors (20 pancreatic, 5 colorectal) who were positive for minimal residual mKRAS disease after locoregional treatment.Direct ex vivo mKRAS-specific T cell responses were observed in 21/25 patients (84%; 59% both CD4+ and CD8+).Tumor biomarker responses were observed in 21/25 patients (84%) and biomarker clearance in 6/25 patients, as determined by tumor-informed circulating tumor DNA (24%; 3 pancreatic, 3 colorectal).At 8.5 months median follow-up the median RFS of the 25-patient cohort was 16.33 months.Efficacy correlated with T cell response (≥ versus < median: 12.75-fold over baseline):Median tumor biomarker reduction was -76.0% compared to -10.2% in above versus below median T cell responders, respectively (p<0.0014).Median RFS was not reached compared to 4.01 months in above versus below median T cell responders, respectively (HR 0.14, 95% CI 0.03 to 0.63, p=0.0167).Patients with greater than median T cell response had an 86% reduction in the risk of progression or death.The association of RFS with T cell response was not correlated to baseline prognostic variables including tumor stage, recovery from prior cytotoxic therapy as assessed by absolute neutrophil count or immune system subsets such as %CD4+ or %CD8+ of CD3+ lymphocytes.RFS was shorter in patients who began treatment with a low absolute lymphocyte count.No safety concerns were identified, and no dose limiting toxicities and no ≥ grade 3 treatment related adverse events were observed. 2023 Financial Results R&D expense for 2023 was $23.8 million, compared to $18.1 million for 2022. The increase in R&D expense was primarily due to increased manufacturing and clinical trial expenses as Elicio initiated the AMPLIFY-7P Phase 1a study and generated a clinical trial product to supply the ongoing Phase 2 trial. G&A expense for 2023 was $11.9 million, compared to $5.6 million 2022. The increase in G&A expense was primarily attributable to professional fees, personnel expenses, and insurance associated with operating as a public company. Net loss for 2023 was $35.2 million, compared to $28.2 million for 2022. Net loss per share for 2023 was $6.96 compared to $89.27 for 2022. The reduction in net loss per share was primarily due to an increase in weighted average common shares outstanding as a result of the reverse merger with Angion Biomedica Corp. in June 2023. Cash and cash equivalents as of December 31, 2023, were $12.9 million, compared to $6.2 million as of December 31, 2022. ELICIO THERAPEUTICS, INC.Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)(in thousands, except share and per share amounts) Year Ended December 31, 2023 2022 Operating expenses: Research and development $23,849 $18,103 General and administrative 11,896 5,630 Total operating expenses 35,745 23,733 Loss from operations (35,745) (23,733)Total other income (expense) 550 (4,475)Net Loss (35,195) (28,208)Other comprehensive income: Foreign currency translation adjustment (197) — Comprehensive loss $(35,392) $(28,208)Net loss per common share, basic and diluted $(6.96) $(89.27)Weighted average common shares outstanding, basic and diluted 5,056,225 315,998 ELICIO THERAPEUTICS, INC.Condensed Consolidated Balance Sheets(unaudited)(in thousands) December 31,2023 December 31,2022Assets Cash and cash equivalents$12,894 $6,156Other current assets3,454 4,561Total current assets16,348 10,717Other assets10,798 11,947Total assets$27,146 $22,664 Liabilities and stockholders’ equity Current liabilities$9,766 $6,868Long-term liabilities6,007 6,881Total liabilities15,773 13,749 Total stockholders’ equity (deficit)11,373 8,915 Total liabilities and stockholders' equity$27,146 $22,664 About Elicio Therapeutics Elicio Therapeutics is a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer. By combining expertise in immunology and immunotherapy, Elicio is engineering investigational Amphiphile (“AMP”) immunotherapies intended to precisely target and fully engage the lymph nodes, the site in our bodies where the immune response is orchestrated. Elicio is engineering lymph node-targeted AMPlifiers, immunomodulators, adjuvants, and vaccines for an array of aggressive cancers. About the Amphiphile Platform Our proprietary Amphiphile (“AMP”) platform delivers investigational immunotherapeutics directly to the “brain center” of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate, and amplify critical immune cells, potentially resulting in the induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function, and durability. We believe our AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based upon preclinical studies. Our AMP platform, originally developed at the Massachusetts Institute of Technology has broad potential in the cancer space to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships. The AMP platform has been shown to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph node-specific engagement driving immune responses of increased magnitude, function, and durability. Cautionary Note on 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 the PSLRA. These include statements regarding Elicio’s planned clinical programs, including planned clinical trials, the potential of Elicio’s product candidates, the expected participation and presentation at upcoming conferences, and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Elicio undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. We use words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. Such forward-looking statements are based on our expectations and involve risks and uncertainties; consequently, actual results may differ materially 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 funding necessary to advance the development of ELI-002 and any other future product candidates, and Elicio’s ability to continue as a going concern; Elicio’s plans to develop and commercialize its product candidates, including ELI-002; the timing of initiation of Elicio’s planned clinical trials, including Elicio’s expected completion of enrollment for the Phase 2 randomized trial in PDAC in the fourth quarter of 2024; the timing of the availability of data from Elicio’s clinical trials, including data from the AMPLIFY-7P Phase 1 study of ELI-002 7P expected in the second quarter of 2024; the timing of any planned investigational new drug application or new drug application; Elicio’s plans to research, develop and commercialize its current and future product candidates; Elicio’s ability to successfully collaborate with existing collaborators or enter into new collaborations, and to fulfill its obligations under any such collaboration agreements; the clinical utility, potential benefits and market acceptance of Elicio’s product candidates; Elicio’s commercialization, marketing and manufacturing capabilities and strategy; Elicio’s ability to identify additional products or product candidates with significant commercial potential; Elicio’s ability to advance ELI-002 outside of PDAC monotherapy and Elicio’s pipeline programs; developments and projections relating to Elicio’s competitors and our industry; the impact of government laws and regulations; Elicio’s ability to protect its intellectual property position; and Elicio’s estimates regarding future revenue, expenses, capital requirements and need for additional financing. New factors emerge from time to time, and it is not possible for us to predict all such factors, nor can we assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. These risks are more fully discussed in the Annual Report on Form 10-K that is expected to be filed with the SEC on March 29, 2024, under the heading “Risk Factors”, and any subsequent reports and other documents filed from time to time with the SEC. Forward-looking statements included in this release are based on information available to Elicio as of the date of this release. Elicio does not undertake any 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 ContactKristin Politi LifeSci Communications kpoliti@lifescicomms.com646-876-4783 Investor Relations ContactHeather DiVecchiaElicio TherapeuticsIR@elicio.com 857-209-0153

AMPLIFY-7P study builds on preliminary positive findings from the 2-peptide formulation of ELI-002 published in Nature Medicine demonstrating tumor biomarker reduction, with strong T cell responses that correlated with reduced risk of relapse and death ELI-002 7P is a 7-peptide formulation of the therapeutic cancer vaccine designed to stimulate an immune response against the seven KRAS mutations that drive 25% of all solid tumors, potentially defeating resistance mechanisms BOSTON, Jan. 17, 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 a Trial in Progress poster presentation on the Phase 1/2 (AMPLIFY-7P) study design at the ASCO Gastrointestinal Cancers (“ASCO GI”) Symposium being held January 18-20, 2024 in San Francisco, CA. The poster describes AMPLIFY-7P, a Phase 1 and randomized Phase 2 study of ELI-002 7P, an investigational therapeutic cancer vaccine, administered as an adjuvant monotherapy treatment for patients with KRAS-mutated pancreatic ductal adenocarcinoma (“PDAC”). “ELI-002 is an off-the-shelf cancer vaccine candidate developed with our proprietary Amphiphile (“AMP”) platform which provides a new ability to deliver these treatments effectively to the ‘command center’ of the immune response – the lymph nodes – where tumor-fighting T cells are generated and equipped,” said Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer. “We are progressing our AMP-powered, lymph node-targeted cancer vaccine, ELI-002 7P, as a monotherapy in an adjuvant setting for patients with pancreatic cancer, and recently dosed the first patient in the randomized Phase 2 cohort. This study builds on positive preliminary data demonstrating our 2-peptide formulation of ELI-002 induced robust and durable tumor-directed mKRAS-specific T cell responses which correlated with tumor biomarker reduction or clearance, and reduced risk of relapse and death.” Zev A. Wainberg, M.D., Professor of Medicine, University of California, Los Angeles (UCLA), Co-Director, the UCLA GI Oncology Program, added, “Patients with RAS mutated pancreatic cancers who have positive circulating tumor DNA post-surgery are often quick to relapse. Our current standard of care for these patients is observation – there are no treatments given during this ‘wait and see’ observation window before relapse. As we progress to Phase 2 of the study, we seek to compare ELI-002 7P to our current standard of care to further evaluate its antitumor activity and clinical benefit in the adjuvant setting as well as with bulkier cancer treated at the time of relapse in crossover patients with mKRAS-driven pancreatic cancer.” Poster Presentation Highlights Title: AMPLIFY-7P: Phase 1 and randomized phase 2 study of amphiphile immunotherapy ELI-002 7P as adjuvant treatment for subjects with G12D, G12R, G12V, G12C, G12A, G12S and G13D Kirsten rat sarcoma (KRAS)-mutated pancreatic ductal adenocarcinoma Session Title: Trial in Progress Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract Session Time: January 19, 2024, 12:30-2:00 PM PT Presenter: Zev A. Wainberg, M.D., Professor of Medicine, University of California, Los Angeles (UCLA), Co-Director, the UCLA GI Oncology Program Abstract #: TPS720 Poster Bd #: Q9 ELI-002 7P is an investigational therapeutic cancer vaccine developed with Elicio’s proprietary lymph node-targeting AMP technology to treat cancers driven by seven common mutations in KRAS (G12D, G12R, G12V, G12A, G12C, G12S and G13D). AMPLIFY-7P is a Phase 1 and Phase 2 study of ELI-002 7P in patients with RAS mutated pancreatic and colorectal tumors after locoregional treatment. It is comprised of: Phase 1A safety evaluation of ELI-002 7P in which a cohort of ~13 patients received fixed 10.0 mg doses of AMP-CpG adjuvant at one of two AMP-Peptides 7P doses levels (1.4 mg or 4.9 mg); 1A cohort has been completed with no dose-limiting toxicities Phase 1B dose expansion to evaluate ELI-002 7P in a cohort of ~9-17 patients with colorectal cancer; planned but not currently active Phase 2 randomized 2:1 study that will assess disease free survival with recommended Phase 2 dose of ELI-002 7P (10.0 mg AMP-CpG with 4.9 mg AMP-peptides 7P) in ~90 patients with PDAC as compared to ~45 patients with PDAC who receive standard of care (observation) with crossover of the observation arm permitted at the time of confirmed radiographic relapse via iRECIST. Treatment included an immunization period of eight weeks in which six ELI-002 7P doses were administered, followed by a booster period (two months after immunization period) in which 4 additional ELI-002 7P doses were administered over the course of 4 weeks. Follow up continued up to 36 months. Patients receive up to 10 doses of Amph-peptides 7P 700 mcg each (4.9 mg total), together with Amph-CpG-7909 (10.0 mg) administered over a five-month treatment period. Primary endpoint of Phase 1 was safety and Phase 2 is disease free survival per investigator (iRECIST) Secondary endpoints are biomarker reduction or clearance of ctDNA or if ctDNA was not detectable, serum tumor antigen CA19-9, in the subset with positive baseline values, median overall survival, safety and iRECIST response rate in the crossover subset. Exploratory endpoints include the association of immunogenicity with high resolution HLA typing and evaluation of tumor-infiltrating T cells and the tumor microenvironment in the event biopsy tissue is available. A Phase 2 interim analysis is planned using group sequential design for control of overall alpha 0.10. Inclusion criteria includes: KRAS mutations (G12D, G12V, G12R, G12C, G12A, G12S or G13D) Eligible PDAC patients for Phase 2 must be within 6 months of completion of locoregional treatment for up-front resectable pathologically confirmed pancreatic cancer (Stage I-III) with radiographic NED (no evidence of disease). Phase 2 patients are included regardless of biomarker evidence of recurrent disease, however, those who have not recovered absolute lymphocytes to the normal range following cytotoxic therapy are excluded. About ELI-002 ELI-002 is a structurally novel investigational AMP therapeutic immunotherapy targeting mutant KRAS-driven cancers. KRAS mutations are among the most prevalent human cancers. The seven KRAS driver mutations targeted by the ELI-002 7P formulation are present in 25% of all solid tumors. In particular, 93% of pancreatic ductal adenocarcinoma and 52% of colorectal cancers, those most prevalent in the AMPLIFY-201 study, are positive for KRAS mutations. In addition, 27% of non-small cell lung cancers are positive for KRAS mutations. ELI-002 is comprised of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified immune-stimulatory oligonucleotide CpG adjuvant available as an off-the-shelf subcutaneous administration. The AMP mKRAS peptides and AMP CpG are targeted to the lymph node where they can potentially enhance the action of key immune cells. ELI-002 2P is currently being studied in a Phase 1 trial (“AMPLIFY-201”) in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy (NCT04853017). ELI-002 7P, is currently being studied in AMPLIFY-7P, a Phase 2 trial in patients with high relapse risk mKRAS-driven solid tumors (NCT05726864). The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations, thereby increasing the potential patient population for ELI-002 and potentially reducing the chance of bypass resistance mechanisms. About Elicio Therapeutics Elicio Therapeutics is a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer. By combining expertise in immunology and immunotherapy, Elicio is engineering investigational AMP immunotherapies intended to precisely target and fully engage the lymph nodes, the site in our bodies where the immune response is orchestrated. Elicio is engineering lymph node-targeted AMPlifiers, immunomodulators, adjuvants and vaccines for an array of aggressive cancers. Cautionary Note on 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 the PSLRA. These include statements regarding Elicio’s planned clinical programs, including planned clinical trials, the potential of Elicio’s product candidates, and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Elicio undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. We use words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. Such forward-looking statements are based on our expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, Elicio’s plans to develop and commercialize its product candidates, including ELI-002; the timing of the availability of data from Elicio’s clinical trials; and Elicio’s plans to research, develop and commercialize its current and future product candidates. New factors emerge from time to time, and it is not possible for Elicio to predict all such factors, nor can Elicio assess the impact of each such factor on Elicio’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. These risks are more fully discussed in Elicio’s current report on Form 8-K that was filed with the SEC on June 2, 2023 and Elicio’s periodic reports and other documents filed from time to time with the SEC. Forward-looking statements included in this release are based on information available to Elicio as of the date of this release. Elicio does not undertake any 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 Kristin Politi LifeSci Communications kpoliti@lifescicomms.com 646-876-4783 Investor Relations Contact Heather DiVecchia Elicio Therapeutics IR@elicio.com 857-209-0153