Core Viewpoint - Elicio Therapeutics has secured a $10 million senior secured promissory note to extend its operational runway into Q1 2026, supporting its clinical development initiatives, particularly the AMPLIFY-7P Phase 2 interim analysis expected in Q3 2025 [2][4]. Financial Summary - The company received gross proceeds of $10 million from the Note Financing, which bears an interest rate of up to 12.5% and matures on June 3, 2028 [3]. - The financing includes a 24-month interest-only period, with interest accrued during the first 12 months payable in a lump sum starting from the thirteenth month [3]. Product Development - Elicio's lead product candidate, ELI-002, targets mKRAS-driven tumors, which account for approximately 25% of all solid tumors [4][5]. - ELI-002 is currently being studied in a randomized clinical trial for mKRAS-positive pancreatic cancer and has shown promising Phase 1 data, including a 16.3-month median recurrence-free survival and a 28.9-month median overall survival [4][6]. Technology Platform - Elicio's proprietary Amphiphile (AMP) platform is designed to enhance the education and activation of cancer-specific T cells, aiming for durable cancer immunosurveillance [4][7]. - The AMP technology allows for targeted delivery of immunotherapeutics to lymph nodes, potentially leading to superior clinical outcomes compared to conventional therapies [7][8]. Future Plans - The company plans to explore combination regimens for ELI-002 in treating pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer, leveraging robust interest from clinical investigators [4]. - Elicio intends to expand ELI-002 to other indications, including mKRAS-positive lung cancer, and is developing additional off-the-shelf therapeutic cancer vaccine candidates [4][6].

Financial Performance - The company experienced a net loss of $11.209 million for the three months ended March 31, 2025, compared to a net loss of $11.827 million for the same period in 2024, representing a 5.2% improvement[19]. - Total operating expenses for the first quarter of 2025 were $10.736 million, up from $10.241 million in the first quarter of 2024, indicating a 4.8% increase[19]. - The accumulated deficit as of March 31, 2025, stood at $205.310 million, up from $194.101 million at the end of 2024[18]. - The company reported a net loss of $11.2 million for the three months ended March 31, 2025, compared to a net loss of $11.8 million for the same period in 2024, reflecting a decrease of $0.6 million[128]. - Clinical trial expenses increased to $4.2 million for the three months ended March 31, 2025, up from $2.3 million in the prior year[104]. - Research and development expenses were $7.8 million for the three months ended March 31, 2025, a 3% increase from $7.6 million in the prior year, primarily due to higher clinical trial expenses[129]. - General and administrative expenses rose by 10% to $3.0 million for the three months ended March 31, 2025, compared to $2.7 million in the same period of 2024, mainly due to increased professional fees[130]. Cash Flow and Liquidity - Cash and cash equivalents increased to $18.351 million as of March 31, 2025, from $17.618 million at the end of 2024, reflecting a 4.2% rise[18]. - Elicio's cash flows from operating activities showed a net cash used of $10.119 million for the first quarter of 2025, compared to $12.122 million for the same period in 2024, marking a 16.5% reduction[25]. - The company expects to fund operations into the fourth quarter of 2025 based on current cash on hand, but substantial doubt exists regarding its ability to continue as a going concern[111]. - The company expects to incur substantial expenditures for the development of its product candidates and will require additional financing[28]. - The company expects its cash and cash equivalents to be sufficient to fund planned operations into the fourth quarter of 2025, although future funding requirements are uncertain[141]. Shareholder Equity and Stock Activity - Elicio's stockholders' equity improved to $8.904 million as of March 31, 2025, compared to a deficit of $11.312 million at the end of 2024[18]. - The company reported a weighted average of 12,950,574 common shares outstanding for the first quarter of 2025, compared to 10,273,925 shares for the same period in 2024, indicating a 26.4% increase in shares outstanding[19]. - The company issued 615,363 shares under the 2022 ATM Program, generating net proceeds of approximately $5.1 million during the three months ended March 31, 2024[57]. - In the three months ended March 31, 2025, the company issued 106,823 shares under the 2024 ATM Program, resulting in net proceeds of approximately $0.8 million[58]. - The January 2025 Offering resulted in net proceeds of $9.2 million after deducting placement agent fees, with 1,261,830 shares sold at a combined offering price of $7.925[62]. Liabilities and Financial Obligations - Elicio's total liabilities decreased significantly to $19.240 million as of March 31, 2025, from $39.490 million at the end of 2024, representing a 51.2% reduction[18]. - Total liabilities, including warrant liability, were $2.962 million as of March 31, 2025, compared to $2.828 million on December 31, 2024[38]. - Accrued expenses decreased from $8.415 million on December 31, 2024, to $5.770 million on March 31, 2025[50]. - The company issued 3,500,573 shares of common stock in March 2025 to satisfy the full amount of a $20.0 million convertible note, resulting in no outstanding debt as of March 31, 2025[93]. 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[156][159]. - Remediation efforts for identified material weaknesses include hiring additional finance personnel and engaging consultants for compliance and technical accounting[160]. - The company has not fully remediated material weaknesses as of March 31, 2025, and continues to disclose these weaknesses in its financial reports[161]. - The effectiveness of internal control over financial reporting is subject to inherent limitations, and the company intends to continue monitoring and upgrading its controls[162]. Market and Regulatory Environment - The company has not yet had any products approved for sale and does not expect to generate product sales until regulatory approval is obtained[116]. - The United States imposed broad tariffs in April 2025, particularly affecting imports from China, which may lead to increased costs for materials[168]. - There have been no material changes in the company's risk factors, but significant political and trade developments, including tariffs, could adversely impact financial conditions[168]. Future Outlook - The company plans to address its financial condition through the sale of common stock or other securities, but there is no assurance that these plans will be successful[112]. - The clinical pipeline includes ELI-002, currently in Phase 2 trials, with an interim analysis expected in Q3 2025[109].

Core Insights - Elicio Therapeutics is progressing towards an interim analysis focused on disease-free survival in the Phase 2 AMPLIFY-7P clinical trial, expected in Q3 2025, which is a significant milestone for the company and patients with pancreatic ductal adenocarcinoma [1][2] - The company has aligned with the FDA on key design elements for a planned Phase 3 study of ELI-002, indicating regulatory support for its development [1][8] - Elicio's current cash position of $18.4 million is expected to support operations into Q4 2025, beyond the anticipated interim analysis [6][7] Financial Performance - Research and development expenses for Q1 2025 were $7.8 million, a slight increase from $7.6 million in Q1 2024, primarily due to clinical trial costs [4] - General and administrative expenses rose to $3.0 million in Q1 2025 from $2.7 million in Q1 2024, attributed to higher compensation and benefits [5] - The net loss for Q1 2025 was $11.2 million, compared to $11.8 million in Q1 2024, with a net loss per share of $0.87, down from $1.15 in the previous year [6][10] Clinical Development - ELI-002 is being studied as a potential treatment for mKRAS-driven tumors, with the upcoming interim data readout in PDAC seen as a critical validation opportunity for the AMP platform [2][8] - The company plans to finalize the pivotal Phase 3 trial protocol for ELI-002 in resected mKRAS PDAC in the second half of 2025 [8][19] - Elicio's AMP technology aims to enhance the immune response against cancer by delivering antigens directly to lymph nodes, which may lead to improved therapeutic outcomes [16][17] Corporate Updates - In March 2025, Elicio appointed Preetam Shah, Ph.D., MBA, as Chief Strategy and Financial Officer, indicating a strengthening of its leadership team [8] - The company raised $10 million through a registered direct offering of common stock and warrants in January 2025, bolstering its cash position [8]

Core Viewpoint - Elicio Therapeutics (ELTX) has experienced a recent decline in share price, but the formation of a hammer chart pattern suggests a potential trend reversal due to increased buying interest and positive earnings estimate revisions from analysts [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottoming out of the stock, with reduced selling pressure and a shift in control from bears to bulls [2][5]. - This pattern is characterized by a small candle body with a long lower wick, suggesting that the stock found support after hitting a new low during a downtrend [4][5]. - Hammer candles can appear on various timeframes and are relevant for both short-term and long-term investors [5]. Fundamental Analysis - There has been a notable upward trend in earnings estimate revisions for ELTX, which is a bullish indicator suggesting potential price appreciation [7]. - Over the last 30 days, the consensus EPS estimate for the current year has increased by 9.9%, indicating that analysts expect better earnings than previously predicted [8]. - ELTX holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [9].

Core Insights - Elicio Therapeutics has granted inducement awards to its newly appointed Chief Strategy and Financial Officer, Preetam Shah, and two additional employees as part of their employment agreement [1][2] - The inducement awards consist of 191,624 stock options for Dr. Shah and a total of 21,000 stock options for the other two employees, with an exercise price of $4.98 per share [2] - The stock options will vest over four years, with 25% vesting on the first anniversary of the respective start dates and the remainder vesting monthly thereafter [3] Company Overview - Elicio Therapeutics is a clinical-stage biotechnology company focused on developing novel immunotherapies for high-prevalence cancers, including mKRAS-positive pancreatic and colorectal cancers [4] - The company aims to leverage its Amphiphile ("AMP") technology to enhance the activation of cancer-specific T cells, promoting durable cancer immunosurveillance [4] - Elicio's lead program, ELI-002, targets common KRAS mutations found in approximately 25% of all solid tumors and is currently in a randomized clinical trial for patients with mKRAS-positive pancreatic cancer [4]

Company Performance - Elicio Therapeutics (ELTX) has returned approximately 7.8% year-to-date, outperforming the average gain of 0.9% in the Medical sector [4] - The Zacks Consensus Estimate for ELTX's full-year earnings has increased by 23% over the past quarter, indicating improved analyst sentiment and a stronger earnings outlook [3] Industry Context - Elicio Therapeutics is part of the Medical - Biomedical and Genetics industry, which consists of 509 individual stocks and currently ranks 75 in the Zacks Industry Rank [6] - Stocks in the Medical - Biomedical and Genetics industry have experienced an average loss of about 0.3% year-to-date, highlighting ELTX's superior performance within this group [6] Comparative Analysis - Inventiva S.A. Sponsored ADR (IVA) is another Medical stock that has significantly outperformed the sector, with a year-to-date return of 41.1% [4] - The consensus EPS estimate for Inventiva S.A. has increased by 40.1% over the past three months, and it also holds a Zacks Rank of 2 (Buy) [5]

Core Viewpoint - Elicio Therapeutics (ELTX) has received a Zacks Rank 2 (Buy) upgrade, indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system is based on changes in earnings estimates, which are closely correlated with stock price movements, making it a valuable tool for investors [2][4]. - The recent upgrade for Elicio Therapeutics reflects an improvement in the company's earnings outlook, likely leading to an increase in its stock price [5][10]. Earnings Estimate Revisions - For the fiscal year ending December 2025, Elicio Therapeutics is projected to earn -$2.79 per share, representing a 34.4% change from the previous year's reported figure [8]. - Over the past three months, the Zacks Consensus Estimate for Elicio Therapeutics has increased by 23%, indicating a positive trend in earnings estimates [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [7]. - Elicio Therapeutics' upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION 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, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-39990 Elicio Therapeutics, Inc. (E ...

Core Insights - Elicio Therapeutics has made significant advancements in its cancer immunotherapy pipeline, notably completing enrollment in its first randomized Phase 2 clinical trial, AMPLIFY-7P, which is expected to yield interim analysis results in Q3 2025 [2][5] - The company has aligned with the FDA on key elements for the Phase 3 study design of ELI-002, focusing on dose, patient population, and primary endpoint analysis [1][5] - Elicio has strengthened its cash position, with expectations to support operations into Q4 2025, beyond the upcoming interim analysis [1][8] Recent Highlights - Elicio presented promising Phase 1a data for ELI-002, showing a strong correlation between T cell response and anti-tumor activity across two monotherapy trials involving 39 patients [2] - The Phase 2 AMPLIFY-7P trial has successfully enrolled 144 patients with post-resection mKRAS pancreatic ductal adenocarcinoma, randomized 2:1 to receive ELI-002 or standard care [5] - Updated results from the Phase 1a AMPLIFY-201 trial indicated a median recurrence-free survival of 16.3 months and a median overall survival of 28.9 months [5] Financial Overview - Research and development expenses for 2024 were $33.7 million, up from $23.8 million in 2023, primarily due to clinical trial costs [6] - General and administrative expenses decreased slightly to $11.3 million in 2024 from $11.9 million in 2023 [6] - The net loss for 2024 was $51.9 million, compared to $35.2 million in 2023, with a net loss per share of $4.25 [7] Cash Position - As of December 31, 2024, Elicio had cash and cash equivalents of $17.6 million, an increase from $12.9 million in 2023 [7][10] - The company anticipates that its current cash position, bolstered by a $10 million direct offering in January 2025, will support operations into Q4 2025 [8] Upcoming Milestones - The DFS event-driven interim analysis for the Phase 2 AMPLIFY-7P trial is expected in Q3 2025, contingent on the rate of event accrual [5] - Elicio aims to finalize the pivotal Phase 3 trial protocol for ELI-002 in resected mKRAS pancreatic ductal adenocarcinoma in the second half of 2025 [5]

Core Insights - Elicio Therapeutics has appointed Preetam Shah, Ph.D., MBA, as Chief Strategy and Financial Officer, bringing extensive leadership experience from previous roles in biotechnology companies [1][2][3] Company Overview - Elicio Therapeutics is a clinical-stage biotechnology company focused on developing novel immunotherapies for cancer treatment, particularly targeting high-prevalence cancers such as mKRAS-positive pancreatic and colorectal cancers [4] - The company aims to leverage its Amphiphile ("AMP") technology to enhance the education, activation, and amplification of cancer-specific T cells, promoting durable cancer immunosurveillance [4][8] Product Pipeline - Elicio's lead product candidate, ELI-002, is an off-the-shelf vaccine targeting common KRAS mutations, which are responsible for approximately 25% of all solid tumors [4][7] - ELI-002 is currently being studied in a Phase 1/2 clinical trial (AMPLIFY-7P) for patients with mKRAS-positive pancreatic cancer who are at high risk of relapse [7] - The company also has additional candidates in its pipeline, including ELI-007 and ELI-008, targeting BRAF-driven cancers and p53 hotspot mutations, respectively [4] Technology Platform - The AMP platform is designed to deliver immunotherapeutics directly to lymph nodes, enhancing immune responses and potentially leading to more effective cancer treatments [8][10] - Elicio's technology has shown promise in preclinical models, indicating that lymph node-specific engagement can drive stronger and more durable therapeutic immune responses [10]