Core Insights - Elicio Therapeutics presented updated results from the Phase 1 AMPLIFY-201 clinical trial for ELI-002, showing a median recurrence-free survival (mRFS) of 16.3 months and median overall survival (mOS) of 28.9 months in patients with KRAS-mutant tumors [1][3] - A strong correlation was observed between T cell response and mRFS, with ongoing trials expected to provide further insights in H1 2025 [2][3] Company Overview - Elicio Therapeutics is a clinical-stage biotechnology company focused on developing novel immunotherapies for high-prevalence cancers, particularly mKRAS-positive pancreatic and colorectal cancers [4][5] - The company's lead product candidate, ELI-002, is an off-the-shelf cancer vaccine targeting common KRAS mutations, which are implicated in approximately 25% of all solid tumors [5][6] Clinical Trial Details - The AMPLIFY-201 trial enrolled 25 patients, including 20 with pancreatic ductal adenocarcinoma (PDAC) and 5 with colorectal cancer (CRC), all at high risk of relapse after surgery [2][3] - ELI-002 demonstrated a favorable safety profile, with no severe treatment-emergent adverse events reported [3] Efficacy Data - The updated data showed that patients with above-median T cell responses had not yet reached mRFS, while those with below-median responses had a mRFS of 4.0 months [3] - The mOS for the full study cohort was 28.9 months, which is comparable to historical controls for PDAC [3] Future Developments - Elicio is advancing a seven-peptide formulation of ELI-002 (ELI-002 7P) in a randomized Phase 2 study, with interim analysis expected in H1 2025 [2][6] - The company aims to leverage its AMP technology to enhance immune responses and improve patient outcomes in cancer treatment [7][9]

Financial Performance - The net loss for the three months ended September 30, 2024, was $18,838,000, compared to a net loss of $10,658,000 for the same period in 2023, indicating a 77% increase in losses[12]. - The comprehensive loss for the three months ended September 30, 2024, was $18,802,000, up from $10,681,000 in the prior year[12]. - The company reported a net loss per common share of $1.39 for the three months ended September 30, 2024, compared to $1.27 for the same period in 2023[12]. - The net loss for the quarter ending September 30, 2024, was $18,838,000, compared to a net loss of $11,827,000 for the previous quarter[15]. - For the nine months ended September 30, 2024, the net loss was $37.9 million, up from $26.2 million in the same period of 2023, indicating a 44.6% increase in losses[104]. - For the three months ended September 30, 2024, the company reported a net loss of $18.8 million, compared to a net loss of $10.7 million for the same period in 2023, representing a 76.5% increase in losses year-over-year[104]. Cash and Liquidity - Cash and cash equivalents increased to $26,016,000 as of September 30, 2024, up from $12,894,000 at December 31, 2023, representing a 102% increase[10]. - The company has a significant cash runway, with existing cash and cash equivalents expected to fund planned operating expenses and capital expenditures[7]. - The company had $26.0 million in cash and cash equivalents at the end of the reporting period, which raises concerns about its ability to continue as a going concern[22]. - The company believes its cash and cash equivalents will be sufficient to fund operations into Q2 2025, but future funding needs are uncertain and depend on various factors[140]. - The company plans to address its liquidity issues through potential sales of common stock or other securities, debt financings, and strategic partnerships[22]. Assets and Liabilities - Total current assets rose to $30,646,000, compared to $16,348,000 at the end of 2023, marking an increase of 88%[10]. - Total liabilities increased significantly to $57,374,000 from $15,773,000, reflecting a growth of 264%[10]. - As of September 30, 2024, the total stockholders' equity was $161,355,000, with an accumulated deficit of $180,097,000[15]. - The company’s total liabilities included warrant liabilities of $23.18 million as of September 30, 2024[58]. - Total accrued expenses increased to $4.85 million as of September 30, 2024, up from $3.76 million at the end of 2023, driven by higher accrued research and development costs[68]. Research and Development - Research and development expenses for the three months ended September 30, 2024, were $7,208,000, slightly down from $7,264,000 in the same period of 2023[12]. - Research and development expenses for the nine months ended September 30, 2024, were $22.9 million, up 30% from $17.7 million in the same period of 2023[129]. - The company expects substantial increases in research and development expenses as it continues to invest in product candidate development and clinical trials[126]. - The company anticipates significant increases in research and development expenses as it advances its product candidates and seeks regulatory approvals[116]. Stock and Equity - The weighted average common shares outstanding increased to 13,582,345 for the three months ended September 30, 2024, from 8,376,384 in the prior year[12]. - The company issued 510,000 common shares from an At-the-Market offering, net of issuance costs of $517,000, resulting in an increase in additional paid-in capital by $1,075,000[15]. - The total common shares outstanding increased to 10,784,377 as of September 30, 2024, from 10,258,873 as of June 30, 2024[15]. - The company completed a merger resulting in the issuance of 5,375,751 shares of Angion common stock to Former Elicio stockholders, with a total of 8,387,025 shares outstanding post-merger[55]. - The company raised approximately $6.0 million from a private placement in March 2024, which is part of its strategy to secure additional funding[109]. Financing Activities - The company closed a public offering in July 2024, generating net proceeds of $10.9 million from the sale of 500,000 shares and 1,800,000 pre-funded warrants[62]. - The company entered into a 3% Senior Secured Convertible Promissory Note financing of $20.0 million in August 2024, with net proceeds of approximately $19.7 million after deducting debt issuance costs[100]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $42.1 million, an increase from $31.6 million in the same period of 2023[139]. Accounting and Compliance - The company is currently assessing the impact of recently issued accounting standards on its financial statements, including ASU No. 2023-07 and ASU No. 2023-09[52]. - The company has not reported any material changes in critical accounting policies during the nine months ended September 30, 2024, compared to previous disclosures[142]. - The company evaluated its Convertible Note and determined that certain features met the definition of a derivative, but the value was de minimis[143]. - The company follows ASC Topic 820 for fair value measurements, categorizing inputs into three levels, with Level 3 requiring the most judgment[38]. Future Outlook - The company may need to delay or limit product development if unable to raise additional funds through equity or debt financings[141]. - The company’s future funding requirements will depend on the progress and costs of research and development, clinical trials, and regulatory approvals[140]. - The company has not yet had any products approved for sale and does not expect to generate product sales until regulatory approval is obtained[118].

Core Insights - Elicio Therapeutics is advancing its pipeline of novel cancer immunotherapies, with significant progress reported in the AMPLIFY-7P Phase 1a trial, showing durable T cell responses and potential disease-free survival benefits in patients with KRAS mutant tumors [2][3] - The company has strengthened its cash position, which is expected to support operations into Q2 2025, beyond the anticipated interim analysis of the AMPLIFY-7P Phase 2 study [2][8] Clinical Developments - The AMPLIFY-7P Phase 2 randomized study is expected to complete enrollment in Q4 2024, with a formal interim analysis of disease-free survival anticipated in H1 2025 [1][4] - Elicio presented data at the SITC 2024 Annual Meeting, highlighting the clinical efficacy of ELI-002 in mKRAS-driven solid tumors, including tumor biomarker reductions and robust T cell responses [2][3] - Upcoming presentations include updated relapse-free survival and overall survival data from the AMPLIFY-201 study at the 2024 ESMO Immuno-Oncology Congress [4] Financial Performance - For Q3 2024, Elicio reported R&D expenses of $7.2 million, slightly down from $7.3 million in Q3 2023, primarily due to reduced clinical trial expenses [5] - General and administrative expenses decreased to $3.1 million in Q3 2024 from $3.5 million in Q3 2023, attributed to lower external costs related to a merger [6] - The net loss for Q3 2024 was $18.8 million, compared to $10.7 million in Q3 2023, with a net loss per share of $1.39 [7] Cash Position - As of September 30, 2024, Elicio had cash and cash equivalents of $26.0 million, an increase from $12.9 million at the end of 2023, indicating improved liquidity [10] - The company has implemented operational changes to reduce expenses, ensuring that current cash reserves will support operations into Q2 2025 [8]

Core Viewpoint - Elicio Therapeutics (ELTX) has received a Zacks Rank 1 (Strong Buy) upgrade, indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][2]. Earnings Estimates and Revisions - The Zacks Consensus Estimate for Elicio Therapeutics for the fiscal year ending December 2024 is projected at -$3.39 per share, reflecting a 51.3% change from the previous year's reported figure [5]. - Over the past three months, analysts have increased their earnings estimates for Elicio Therapeutics by 7.9% [5]. Impact of Institutional Investors - Changes in earnings estimates are strongly correlated with stock price movements, with institutional investors using these estimates to assess the fair value of a company's shares [3]. - An increase in earnings estimates typically leads to higher fair value calculations, prompting institutional investors to buy or sell stocks, which subsequently affects stock prices [3]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [4]. - The upgrade of Elicio Therapeutics to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, indicating a strong potential for near-term price increases due to superior earnings estimate revisions [6].

Core Insights - Elicio Therapeutics, a clinical-stage biotechnology company, is advancing a pipeline of novel immunotherapies for cancer treatment and has announced upcoming presentations at key conferences in September and October 2024 [1][6]. Presentation Details - The first presentation will be at the AACR Special Conference on Advances in Pancreatic Cancer Research from September 15-18, 2024, featuring Dr. Eileen O'Reilly discussing recent Phase I AMPLIFY-7P trial updates [2][3]. - The second presentation will occur at the RAS-Targeted Drug Development Summit on September 25, 2024, where Dr. Pete DeMuth will present on the clinical translation of Elicio's RAS-targeted Amphiphile vaccines [3][4]. - The third presentation is scheduled for the Advances in Cancer Vaccines Summit on October 1, 2024, with Dr. Christopher Haqq discussing Phase I experiences with ELI-002 2P and ELI-002 7P [4][5]. Financial and Clinical Updates - Elicio has raised $43 million in funding in 2024, which is expected to support operations into the second quarter of 2025 [5]. - The company anticipates providing additional clinical data updates from the AMPLIFY-201 trial in the fourth quarter of 2024 and interim analysis from the AMPLIFY-7P randomized Phase 2 trial in the first quarter of 2025 [5]. Company Overview - Elicio Therapeutics focuses on developing lymph node-targeted immunotherapies for aggressive cancers, utilizing its proprietary AMP technology to enhance the immune system's cancer-fighting capabilities [6][8]. - The AMP platform is designed to deliver immunotherapeutics directly to lymph nodes, aiming to optimize the immune response against tumors [8][10]. - Elicio's R&D pipeline includes therapeutic cancer vaccines targeting mKRAS-driven cancers (ELI-002) and other mutations [7][9].

Financial Performance - Cash and cash equivalents decreased from $12.894 million at December 31, 2023, to $3.425 million at June 30, 2024, representing a decline of approximately 73%[9] - Total operating expenses for the three months ended June 30, 2024, were $10.924 million, up 40% from $7.777 million for the same period in 2023[12] - The net loss for the three months ended June 30, 2024, was $7.229 million, slightly improved from a net loss of $7.559 million for the same period in 2023[12] - The company reported a comprehensive loss of $7.197 million for the three months ended June 30, 2024, compared to a comprehensive loss of $7.561 million for the same period in 2023[12] - The net loss for the six months ended June 30, 2024, was $19,056,000, compared to a net loss of $15,586,000 for the same period in 2023[20] - The net loss for the three months ended June 30, 2024, was $7.2 million, compared to a net loss of $7.6 million for the same period in 2023, representing a decrease of approximately 4.4%[99] - For the six months ended June 30, 2024, the net loss was $19.1 million, an increase from $15.6 million in the same period of 2023, reflecting a rise of approximately 22.5%[109] Research and Development - Research and development expenses increased to $8.180 million for the three months ended June 30, 2024, compared to $4.944 million for the same period in 2023, reflecting a 65% increase[12] - The company anticipates that its research and development expenses will continue to increase significantly as it advances its lead product candidate, ELI-002, to late-stage clinical trials[116] - The company incurred $2.2 million in research and development expenses related to a grant agreement with the GI Research Foundation for the six months ended June 30, 2024[70] Cash Flow and Liquidity - Cash used in operating activities for the six months ended June 30, 2024, was $21,050,000, an increase from $17,614,000 in the prior year[20] - The company expects its cash and cash equivalents to be sufficient to fund operations into the second quarter of calendar year 2025, but acknowledges that projections may be incorrect[136] - The company plans to address its liquidity concerns through the sale of common stock or other securities, debt financings, and strategic partnerships[114] Stock and Equity - The company had 10,273,328 shares issued as of June 30, 2024, compared to 9,618,178 shares issued at December 31, 2023, reflecting an increase of approximately 6.8%[10] - The company issued 615,363 shares of common stock from an At-the-Market offering, net of issuance costs of $103,000[15] - The Company completed a reverse merger with Angion Biomedica Corp. on June 1, 2023, resulting in approximately 9.7 million shares outstanding, with Former Elicio equity holders owning 65.2% and Angion equity holders owning 34.8% on a fully diluted basis[22] Liabilities and Deficits - Total liabilities increased from $15.773 million at December 31, 2023, to $17.402 million at June 30, 2024, marking an increase of approximately 10.4%[10] - The accumulated deficit grew from $142.203 million at December 31, 2023, to $161.259 million at June 30, 2024, indicating an increase of approximately 13.4%[10] - As of June 30, 2024, the Company reported an accumulated deficit of $161.3 million and $3.4 million in cash and cash equivalents, raising substantial doubt about its ability to continue as a going concern[23] Financing Activities - The company raised approximately $6.0 million from a private placement in March 2024, with each Pre-Funded Warrant exercisable at $0.01 per share[102] - A public offering closed on July 1, 2024, generating net proceeds of approximately $10.9 million, with 500,000 shares sold at a combined offering price of $5.00 per share[105] - In August 2024, the company issued a 3% Senior Secured Convertible Promissory Note for $20.0 million, maturing on February 15, 2026[106] Accounting and Reporting - The Company’s financial statements have been prepared in accordance with U.S. GAAP and include the accounts of its wholly owned subsidiaries, Elicio Australia Pty Ltd. and ESC[24] - The Company has elected to account for stock-based awards based on their fair values, recognizing expenses on a straight-line basis over the requisite service period[49] - The company is classified as an emerging growth company and smaller reporting company, allowing it to delay the adoption of new accounting standards[140] Other Key Points - The company has not yet had any products approved for sale and does not expect to generate product sales until regulatory approvals are obtained[114] - The clinical pipeline includes ELI-002, currently in Phase 2 for mutant KRAS cancers, and ELI-007 and ELI-008 in preclinical studies for BRAF and TP53-driven cancers, respectively[110] - The company has raised aggregate net proceeds of $152.0 million since inception through various financing methods, including stock issuances and convertible notes[110]

Core Insights - Elicio Therapeutics reported strong preliminary results from the AMPLIFY-7P Phase 1 trial, showing a 100% mKRAS-specific T cell response among patients, with approximately 66% of responses involving both CD4+ and CD8+ T cells [1][2] - The company raised $43 million in 2024, providing funding into the second quarter of 2025, which supports ongoing clinical trials [1][2] - The AMPLIFY-7P Phase 2 trial is expected to complete enrollment of 135 patients by the fourth quarter of 2024, with interim analysis anticipated in early 2025 [1][6] Clinical Developments - The AMPLIFY-7P trial is a multicenter Phase 1/2 study assessing ELI-002 7P in patients with high relapse risk mutant KRAS-driven solid tumors [2] - Initial data from the ELI-002 Phase 1 trial indicated that the 7-peptide formulation is well-tolerated and generates a significantly larger T cell response compared to the 2-peptide formulation [2][3] - As of the May 24, 2024 data cutoff, patients receiving the recommended Phase 2 dose of 4.9 mg AMP-peptide had not yet reached the median disease-free survival [3][4] Financial Performance - Research and development expenses for Q2 2024 were $8.2 million, up from $4.9 million in Q2 2023, primarily due to increased clinical trial costs [7] - The net loss for Q2 2024 was $7.2 million, a slight improvement from a net loss of $7.6 million in Q2 2023, with a net loss per share of $0.64 compared to $2.61 in the previous year [8][10] - Cash and cash equivalents as of June 30, 2024, were $3.4 million, down from $12.9 million at the end of 2023, not including recent financing proceeds [9][11] Upcoming Milestones - Updated immunogenicity and relapse-free survival data from the AMPLIFY-201 trial is expected in Q4 2024 [6] - Preliminary disease-free survival data from the ELI-002 7P monotherapy Phase 1a arm is anticipated in Q1 2025 [6] - Completion of enrollment for the randomized Phase 2 trial is expected in Q4 2024, with interim analysis in Q1 2025 [6]

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].