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Elicio Therapeutics (ELTX) Update / Briefing Transcript
2025-06-25 19:00
Summary of Alessio Therapeutics Virtual KOL Event Company and Industry - **Company**: Alessio Therapeutics - **Industry**: Cancer Immunotherapy, specifically focusing on pancreatic cancer and KRAS-driven therapies Core Points and Arguments 1. **Introduction of ELI O2 Vaccine**: The event discussed the ELI O2 cancer vaccine aimed at treating mutant KRAS-driven pancreatic cancer, highlighting its innovative approach to cancer vaccination [2][3][32] 2. **Challenges in Cancer Vaccines**: The speakers outlined significant challenges faced by cancer vaccines, including selecting suitable antigens, poor potency in humans, and difficulties in targeting the immune system's command center, the lymph nodes [6][10][12] 3. **Amplify Platform**: The Amplify platform was introduced as a solution to enhance vaccine performance by utilizing lymph node targeting, which is crucial for effective immune response [4][32] 4. **Preclinical Studies**: Preclinical studies demonstrated that the AMP vaccines significantly improved lymph node targeting and T cell activation compared to traditional peptide vaccines, showing a potential increase in immunogenicity [20][30][32] 5. **Clinical Development**: The clinical program for ELI O2 is designed to assess safety, immunogenicity, and clinical outcomes in patients with pancreatic cancer, with a focus on KRAS mutations [55][68] 6. **Neoadjuvant and Adjuvant Therapy**: The discussion included the importance of neoadjuvant therapy in pancreatic cancer, which can shrink tumors and facilitate better surgical outcomes [42][43] 7. **KRAS Targeting**: The significance of KRAS mutations in pancreatic cancer was emphasized, with ongoing research into small molecule inhibitors and immunotherapies targeting these mutations [50][70] Additional Important Content 1. **Immunogenicity and Biomarker Response**: The ELI O2 vaccine showed promising results in inducing T cell responses and reducing circulating tumor DNA (ctDNA) levels in early studies, indicating potential clinical benefits [56][65] 2. **Safety Profile**: The vaccine demonstrated a manageable safety profile with mild side effects, which is crucial for patient acceptance and adherence [68] 3. **Future Directions**: The potential for combining ELI O2 with other therapies, including immune checkpoint inhibitors and chemotherapy, was discussed as a strategy to enhance treatment efficacy [70][71] 4. **Regulatory Considerations**: The design of the phase two and phase three trials was discussed, with a focus on disease-free survival as a primary endpoint, reflecting the regulatory landscape for cancer therapies [72] This summary encapsulates the key discussions and findings presented during the Alessio Therapeutics Virtual KOL Event, focusing on the innovative approaches to cancer vaccination and the specific challenges and opportunities within the pancreatic cancer treatment landscape.
Elicio Therapeutics to Host Virtual KOL Event on June 25, 2025 to Discuss AMP-Powered ELI-002 for the Treatment of KRAS mutation-driven Pancreatic Cancer
Globenewswire· 2025-06-17 12:00
Core Insights - Elicio Therapeutics is hosting a virtual KOL event on June 25, 2025, to discuss the treatment landscape for mutant-KRAS driven pancreatic ductal adenocarcinoma, highlighting the significant unmet medical need in this area [1][2] Company Overview - Elicio Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel immunotherapies for high-prevalence cancers, particularly mKRAS-positive pancreatic and colorectal cancers [8] - The company aims to leverage its proprietary AMP technology to create effective off-the-shelf vaccines, enhancing the education and activation of cancer-specific T cells [8][11] Product Pipeline - Elicio's lead product candidate, ELI-002, is an AMP-powered therapeutic vaccine targeting mKRAS-driven cancers, currently in a randomized Phase 2 trial for adjuvant treatment of PDAC [2][9] - ELI-002 has shown promising results in earlier studies, with a median recurrence-free survival of 16.3 months and a median overall survival of 28.9 months for the full study population [8] - The company plans to expand ELI-002's application to other mKRAS-positive cancers, including lung cancer [8][10] Technology Platform - Elicio's AMP platform is designed to deliver immunotherapeutics directly to lymph nodes, potentially enhancing immune responses compared to conventional therapies [11][12] - The platform has demonstrated the ability to engage lymph nodes specifically, driving therapeutic immune responses of increased magnitude and durability in preclinical models [11][12]
Elicio Therapeutics Secures $10 Million in Financing
Globenewswire· 2025-06-04 12:00
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].
Elicio Therapeutics(ELTX) - 2025 Q1 - Quarterly Report
2025-05-13 20:31
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].
Elicio Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Updates
Globenewswire· 2025-05-13 20:05
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]
Here's Why Elicio Therapeutics (ELTX) Could be Great Choice for a Bottom Fisher
ZACKS· 2025-05-01 14:55
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].
Elicio Therapeutics Reports Inducement Grant to New Chief Strategy and Financial Officer and Other New Hires
Globenewswire· 2025-04-16 20:05
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]
Is Elicio Therapeutics, Inc. (ELTX) Stock Outpacing Its Medical Peers This Year?
ZACKS· 2025-04-04 14:46
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]
Elicio Therapeutics (ELTX) Upgraded to Buy: Here's What You Should Know
ZACKS· 2025-04-03 17:05
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].
Elicio Therapeutics Reports 2024 Financial Results and Provides Corporate Updates
Newsfilter· 2025-03-31 11:00
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]