BOSTON, Nov. 19, 2025 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or the “Company”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced the appointment of Marc J. Wolfgang, M.S. as Chief Technology Officer (“CTO”). Mr. Wolfgang brings more than 30 years of biopharmaceutical leadership spanning manufacturing, CMC strategy, development, quality, and supply chain across modalities including cell therapy, b ...

Financial Performance - As of September 30, 2025, Elicio Therapeutics reported total assets of $28,284,000, an increase from $28,178,000 as of December 31, 2024[19] - The company’s cash and cash equivalents increased to $20,611,000 from $17,618,000, reflecting a growth of approximately 16.9%[19] - Total operating expenses for the three months ended September 30, 2025, were $8,045,000, a decrease of 22.1% compared to $10,344,000 for the same period in 2024[21] - The net loss for the three months ended September 30, 2025, was $10,083,000, compared to a net loss of $18,838,000 for the same period in 2024, representing a reduction of 46.6%[21] - For the nine months ended September 30, 2025, the company reported a net loss of $31.85 million, an improvement from a net loss of $37.89 million for the same period in 2024, representing a decrease of approximately 15.4%[29] - The net loss for the nine months ended September 30, 2025 was $31.9 million, a 16% improvement from a net loss of $37.9 million in the same period of 2024[142] Expenses and Liabilities - Total operating expenses for the three months ended September 30, 2025, were $8,045,000, a decrease of 22.1% compared to $10,344,000 for the same period in 2024[21] - Research and development expenses decreased to $5,039,000 for the three months ended September 30, 2025, down 30.1% from $7,208,000 in the prior year[21] - The company’s total liabilities decreased significantly to $24,468,000 from $39,490,000, indicating a reduction of approximately 38.1%[19] - Total accrued expenses decreased from $8.415 million on December 31, 2024, to $5.213 million on September 30, 2025[53] - Research and development expenses for the nine months ended September 30, 2025, totaled $20.7 million, compared to $24.0 million for the same period in 2024, indicating a decrease of 13.8%[114] Cash Flow and Financing - The company had cash and cash equivalents of $20.61 million as of September 30, 2025, compared to $26.02 million at the end of 2024, indicating a decrease of about 20.8%[33] - Net cash used in operating activities for the nine months ended September 30, 2025, was $30.16 million, slightly higher than $28.32 million for the same period in 2024[29] - The company generated net cash provided by financing activities of $31.83 million for the nine months ended September 30, 2025, compared to $42.09 million for the same period in 2024, a decrease of approximately 24.4%[29] - The company plans to address its liquidity concerns through potential public offerings, private placements, and strategic partnerships, although there is no assurance these plans will be successful[33] - The company expects to incur substantial expenditures for the development of its product candidates, necessitating additional financing in the foreseeable future[33] Stock and Equity - The weighted average common shares outstanding for the three months ended September 30, 2025, were 16,692,476, an increase from 13,582,345 in the prior year[21] - Elicio Therapeutics issued 1,261,830 shares of common stock from the January 2025 Offering, net of issuance costs of $0.8 million[24] - The Company raised approximately $11.4 million in net proceeds from the 2024 ATM Program by selling 1,176,449 shares at a weighted average price of $9.68 per share[60] - The January 2025 Offering resulted in net proceeds of $9.2 million after deducting fees, selling 1,261,830 shares at a combined offering price of $7.925[64] - As of September 30, 2025, there were 806,700 shares of common stock available for issuance under the Company's equity incentive plans[66] Legal and Compliance - The company does not believe it is currently involved in any legal proceedings that would have a material adverse effect on its business[169] - There have been no material changes in the company's risk factors from those described in the Form 10-K[171] - The company has not engaged in any unregistered sales of equity securities during the reporting period[172] - The company has not defaulted on any senior securities[173] Future Outlook - Cash on hand is projected to fund operations through the second quarter of 2026, but there is substantial doubt about the company's ability to continue as a going concern[122] - The company expects its cash and cash equivalents to be sufficient to fund operations through the second quarter of 2026, but may require additional financing[154] - The company plans to address its funding needs through the sale of common stock or other securities, debt financings, or strategic partnerships[156] - The company achieved a milestone related to ongoing clinical trials, recording a license expense of $0.4 million during the nine months ended September 30, 2024[86] Internal Controls and Governance - As of September 30, 2025, the company's disclosure controls and procedures were evaluated as effective by the management team[166] - There were no changes in the internal control over financial reporting during the quarter ended September 30, 2025, that materially affected the internal control[167] - The company continues to take advantage of exemptions from certain disclosure requirements as a smaller reporting company[162]

Core Insights - Elicio Therapeutics reported encouraging results from its Phase 2 AMPLIFY-7P study, indicating fewer disease progressions and deaths than projected, which may positively impact disease-free survival (DFS) [2][5] - The company updated its guidance for the DFS analysis to the first half of 2026 and believes its current cash position will support operations through this critical period [2][9] Recent Highlights - Elicio presented updated data showing that ELI-002 7P induced mutant KRAS-specific T cell responses in 99% of evaluable patients, with an 86% antigen response rate [6] - The company announced a planned investigator-initiated Phase 1 trial of ELI-002 7P in collaboration with Memorial Sloan Kettering Cancer Center, expected to begin in the first half of 2026 [6] - The Independent Data Monitoring Committee recommended continuing the Phase 2 study without modifications, confirming a favorable safety profile for ELI-002 7P [6] Financial Results - R&D expenses for Q3 2025 were $5.0 million, down from $7.2 million in Q3 2024, primarily due to reduced clinical trial costs [5][10] - General and administrative expenses decreased slightly to $3.0 million from $3.1 million year-over-year [7][10] - The net loss for Q3 2025 was $10.1 million, significantly lower than the $18.8 million loss in Q3 2024, with a net loss per share of $0.60 compared to $1.39 [8][10] Cash Position - As of September 30, 2025, Elicio had cash and cash equivalents of $20.6 million, which is expected to support operations through Q2 2026 [8][11][9] - The company raised approximately $11.1 million in gross proceeds since the beginning of Q3 2025, extending its cash runway [5][9] Future Plans - Elicio plans to request an End of Phase 2 meeting with the FDA to finalize the Phase 3 trial design for ELI-002 7P following the DFS analysis [4] - The company aims to expand ELI-002 to other indications, including mKRAS-positive lung cancer and other mKRAS-positive cancers [12][14]

Core Insights - Elicio Therapeutics (ELTX) has been recognized for its promising development of a vaccine targeting KRAS, a significant area in cancer research [1] Company Overview - Elicio Therapeutics has been under observation for approximately five years due to its advancements in vaccine development [1] - The company focuses on the scientific aspects of biotechnology and aims to educate investors about the underlying science [1] Industry Context - The development of vaccines targeting KRAS is crucial in the biotechnology sector, particularly in cancer treatment [1]

Core Insights - Voyageur Pharmaceuticals Ltd. has appointed Virginia Alling as an independent director, enhancing its board with experienced professionals to facilitate U.S. market access and strategic growth [1][3] - Alling brings over 30 years of experience in corporate banking and capital markets, managing a multi-billion-dollar portfolio and specializing in M&A, IPOs, and revenue optimization [2] - The company aims to become a key player in the barium and iodine contrast markets by vertically integrating its operations and producing its own Active Pharmaceutical Ingredients (API) [5][8] Company Strategy - Voyageur is focused on developing high-performance and cost-effective imaging contrast agents, with a strategic plan to partner with established GMP pharmaceutical manufacturers for product validation [6] - The company owns a 100% interest in the Frances Creek barium sulphate project, which is expected to provide a superior quality product compared to current synthetic alternatives [7] - Voyageur's vision includes becoming the first vertically integrated company in the radiology contrast media market, ensuring quality and cost efficiency through control of all primary input costs [8]

Core Insights - Giant Mining Corp. has expanded its engagement with RESPEC Company LLC to incorporate silver assays from recent and historic drilling at the Majuba Hill project, enhancing the project's potential [1][2][3] Engagement Purpose - RESPEC's updated interpretation will include results from the latest drill program, specifically core data from drill holes MHB-30 through MHB-36 [2] - The integration of silver assays will refine the geological model, evaluate new findings' impact on project potential, and guide further drilling strategies [3] Project Highlights - Majuba Hill has previously reported high-grade silver intercepts, including 74.0 feet of 30.1 g/t Ag, emphasizing its polymetallic strength and potential for significant by-product value [4] - The project is located in Nevada, a top-ranked mining jurisdiction, covering 9,684 acres with existing infrastructure that provides cost advantages [7][9] Strategic Impact - The updated interpretation will strengthen the technical foundation for future economic potential and highlight new target zones, aligning with U.S. demand for secure supply chains [7] - The U.S. Geological Survey's recent designation of copper and silver as critical minerals underscores the strategic relevance of Majuba Hill's mineral system [6][7] Market Awareness - The company has entered into a consulting agreement with Plutus Invest & Consulting GmbH for marketing and investor awareness in the European market, with a total payment of EURO 120,000 [12] Company Overview - Giant Mining is focused on advancing late-stage copper and copper/silver/gold projects to meet the growing global demand for critical metals, driven by initiatives like the Green New Deal [13][14] - The Majuba Hill project is positioned to become a significant copper deposit, essential for meeting increasing demand [15]

Core Insights - Elicio Therapeutics announced new immunogenicity data from the Phase 2 AMPLIFY-7P trial for ELI-002 7P, showing strong T cell responses in patients with mKRAS pancreatic ductal adenocarcinoma [1][3][6] - The company also presented preclinical data for ELI-004, indicating over 90% tumor eradication in advanced solid tumors [1][8] Group 1: ELI-002 7P Immunogenicity Data - In the AMPLIFY-7P trial, 99% of 90 evaluable patients achieved robust mKRAS-specific T cell responses, with a mean increase of 145-fold over baseline [4][6] - 85% of patients exhibited combined CD4 and CD8 T cell activation, correlating with clinical activity [4][6] - 88% of patients generated responses to their own tumor-specific mutations, indicating personalized immune activation [4][6] Group 2: ELI-004 Preclinical Data - ELI-004 demonstrated complete tumor eradication in over 90% of cases in preclinical studies, with long-term protection against recurrence [3][8] - The efficacy of ELI-004 was linked to the presence of CD8 T cells and effective lymphocyte trafficking from lymph nodes [8] - This approach suggests a promising off-the-shelf strategy for solid tumor immunotherapy [8] Group 3: Presentation Details - The findings will be presented at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting [2] - The late-breaking abstract for ELI-002 7P highlights its potential to induce robust T cell immunity across diverse HLA backgrounds [6][7] Group 4: Company Overview - Elicio Therapeutics focuses on developing novel immunotherapies targeting high-prevalence cancers, particularly those driven by KRAS mutations [14] - The company's AMP platform aims to enhance immune responses by delivering therapeutics directly to lymph nodes [12][13] - Elicio plans to expand its pipeline to include additional indications for ELI-002 and other candidates targeting different mutations [14]

Core Insights - Elicio Therapeutics announced new immunogenicity data from the Phase 2 AMPLIFY-7P trial for ELI-002 7P, showing strong T cell responses in patients with mKRAS pancreatic ductal adenocarcinoma [1][3][5] - The company also presented preclinical data for ELI-004, indicating its potential to eradicate advanced solid tumors in over 90% of cases [1][8] ELI-002 7P Trial Results - In the AMPLIFY-7P trial, 99% of 90 evaluable patients achieved robust mKRAS-specific T cell responses, with a mean increase of 145-fold over baseline [4][5] - 85% of patients exhibited combined CD4 and CD8 T cell activation, which correlates with clinical activity [5] - 67% of patients responded to all seven mKRAS epitopes, with over 80% response rates to each individual KRAS mutation [4][5] ELI-004 Preclinical Data - ELI-004 demonstrated complete tumor eradication in over 90% of cases in preclinical studies, suggesting long-term protection against recurrence [3][8] - The efficacy of ELI-004 was linked to the presence of CD8 T cells and effective lymphocyte trafficking from lymph nodes [8] HLA Diversity and T Cell Responses - High-resolution HLA typing revealed a diverse HLA repertoire among patients, with 1,132 unique HLAs identified [6] - No significant associations were found between specific HLA types and the magnitude of mKRAS-specific T cell responses, indicating broad applicability of ELI-002 7P [6] Company Overview - Elicio Therapeutics focuses on developing novel immunotherapies targeting high-prevalence cancers, particularly those driven by KRAS mutations [15] - The company's AMP technology aims to enhance immune responses by delivering immunotherapeutics directly to lymph nodes [12][14]

Core Insights - Elicio Therapeutics is presenting new immunogenicity data from its Phase 2 AMPLIFY-7P trial of ELI-002 for mKRAS-driven pancreatic cancer at the SITC Annual Meeting [1] - The company aims to develop off-the-shelf immunotherapies targeting prevalent cancers, leveraging its proprietary AMP technology to enhance T cell responses [3][4] Company Overview - Elicio Therapeutics is a clinical-stage biotechnology company focused on novel immunotherapies for high-prevalence cancers, including mKRAS-positive pancreatic and colorectal cancers [3] - The company's lead product candidate, ELI-002, targets common KRAS mutations found in approximately 25% of all solid tumors [4][5] - Elicio's AMP technology is designed to improve the education and activation of cancer-specific T cells, promoting durable cancer immunosurveillance [3][7] Clinical Trials and Data - ELI-002 is currently being studied in a randomized clinical trial for patients with mKRAS-positive pancreatic cancer who are at high risk of relapse after standard therapy [3][5] - The AMPLIFY-201 Phase 1 trial data showed a median recurrence-free survival of 16.3 months and a median overall survival of 28.9 months for the full study population [3] - Elicio plans to expand ELI-002 to other indications, including mKRAS-positive lung cancer [3] Presentation Details - The late-breaking abstract presentation titled "AMPLIFY-7P Phase 2: T cell responses induced by ELI-002 7P" will be presented by Dr. Lisa McNeil on November 7, 2025 [2] - Another poster presentation titled "AMP-Immunomodulator therapy controls growth and eradicates syngeneic solid tumors" will be presented by Dr. Martin Steinbuck on November 8, 2025 [3]

Core Insights - Elicio Therapeutics has reported preliminary findings from the Phase 2 AMPLIFY-7P trial, indicating that specific Human Leukocyte Antigen (HLA) types do not affect the ability of patients to generate robust mKRAS-specific T-cell responses after treatment with ELI-002 7P [1][3][5] Group 1: Trial Findings - Among 89 patients treated with ELI-002 7P, a total of 1,132 unique HLAs were identified, demonstrating significant genetic diversity within the study population [2][5] - 99% (88 out of 89) of patients assessed for HLA background showed mKRAS-specific T-cell responses post-treatment, suggesting broad applicability of ELI-002 7P for pancreatic ductal adenocarcinoma (PDAC) patients [5][6] - The findings align with recent studies indicating that mKRAS antigens can be presented across a wide range of HLA types, supporting the potential for ELI-002 7P to address a critical unmet need in cancer treatment [2][3] Group 2: Product and Technology Overview - Elicio's lead product candidate, ELI-002, is an off-the-shelf immunotherapy targeting common KRAS mutations, which are responsible for approximately 25% of all solid tumors [4][7] - The AMP technology utilized in ELI-002 aims to enhance the activation and amplification of cancer-specific T cells, potentially leading to durable cancer immunosurveillance [4][9] - Elicio plans to expand the application of ELI-002 to other indications, including mKRAS-positive lung cancer and additional mKRAS-driven cancers, indicating a broad pipeline of therapeutic candidates [6][8]