Core Viewpoint - Elicio Therapeutics has announced a $10 million registered direct offering, leading to a 10% decline in stock price, which is viewed as a potential buying opportunity [2]. Company Summary - Elicio Therapeutics (NASDAQ: ELTX) is currently trading lower due to the recent announcement of a direct offering [2]. - The company is part of a broader analysis service that provides insights into various pharmaceutical companies, including a model portfolio of small and mid-cap stocks [2].

Core Viewpoint - Elicio Therapeutics, Inc. has announced a registered direct offering to institutional investors, aiming to raise approximately $10 million through the sale of 1,261,830 shares of common stock and accompanying warrants, with a purchase price of $7.925 per share [1][2]. Group 1: Offering Details - The offering includes warrants that can be exercised at an exercise price of $7.80 per share, immediately upon issuance, and will expire five years from the initial exercise date [1]. - The closing of the offering is expected to occur on or about January 30, 2025, pending customary closing conditions [1]. - H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering are intended for working capital and other general corporate purposes [2]. Group 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 [5]. - The company is advancing its lead program, ELI-002, which is an off-the-shelf vaccine candidate targeting common KRAS mutations found in approximately 25% of all solid tumors [5]. - Elicio's pipeline also includes additional therapeutic cancer vaccines, ELI-007 and ELI-008, targeting BRAF-driven cancers and p53 hotspot mutations, respectively [5].

Core Insights - Elicio Therapeutics has received supportive FDA feedback on the design of the Phase 3 study for ELI-002, which includes key elements such as dose, schedule, patient population, and primary endpoint analysis [1][2] - The Phase 2 randomized study of ELI-002 is fully enrolled, with an interim analysis of disease-free survival expected in the first half of 2025; positive results could lead to rapid advancement into Phase 3 development [1][2] Company Overview - Elicio Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel immunotherapies for cancer treatment, particularly targeting high-prevalence cancers like mKRAS-positive pancreatic and colorectal cancers [3] - The company aims to leverage recent clinical successes in personalized cancer vaccines to create effective off-the-shelf vaccines [3] - Elicio's lead program, ELI-002, targets common KRAS mutations, which are responsible for approximately 25% of all solid tumors [3][4] Product Details - ELI-002 is an investigational AMP cancer vaccine designed to target cancers driven by KRAS mutations, utilizing Elicio's proprietary AMP technology [4] - The ELI-002 7P formulation is currently being studied in a Phase 1/2 trial for patients with mKRAS-driven pancreatic cancer, aiming to provide immune response coverage against seven common KRAS mutations [5] Technology Platform - Elicio's AMP platform is designed to deliver immunotherapeutics directly to lymph nodes, enhancing the education and activation of immune cells [6][8] - The platform has shown potential in preclinical models to drive therapeutic immune responses with increased magnitude, function, and durability [6][8] - Originally developed at the Massachusetts Institute of Technology, the AMP platform has broad potential for advancing various cancer treatment initiatives [7]

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]