Core Viewpoint - Elicio Therapeutics is initiating a Phase 1 investigator-initiated trial to evaluate ELI-002 7P in combination with chemotherapy and an anti-PD1 checkpoint inhibitor for treating borderline and resectable pancreatic ductal adenocarcinoma (PDAC) [1][2][4] Company Overview - Elicio Therapeutics is a clinical-stage biotechnology company focused on developing novel immunotherapies for cancer, particularly targeting high-prevalence cancers like mKRAS-positive pancreatic and colorectal cancers [11] - The company's lead product candidate, ELI-002, is an investigational AMP cancer vaccine targeting KRAS mutations, which are prevalent in many human cancers [5][11] Trial Details - The upcoming trial will evaluate mFOLFIRINOX in combination with ELI-002 7P, with or without the anti-PD-1 antibody, enrolling 20 patients across two cohorts [2][8] - The trial is expected to commence in the first half of 2026 [2][8] Scientific Rationale - The combination of standard neoadjuvant chemotherapy with innovative immunotherapies aims to convert "cold" tumors into "hot" tumors, enhancing T-cell responses and potentially improving surgical outcomes and long-term survival [3][4] - ELI-002 7P has shown robust T-cell responses in previous trials, targeting the immunosuppressive tumor microenvironment of PDAC [3][4] Future Prospects - If Phase 1 results are positive, the company plans to expand the treatment to a broader population, potentially benefiting more PDAC patients and enhancing commercial opportunities [4][11] - Elicio's AMP technology aims to improve immune activation and promote durable cancer immunosurveillance, with plans to expand ELI-002 to other indications, including mKRAS-positive lung cancer [11]

Core Insights - Elicio Therapeutics announced promising immunogenicity data from its Phase 2 AMPLIFY-7P trial, showing that approximately 99% of evaluable patients generated strong mKRAS-specific T cell responses with an average increase of 145.3 times over baseline [1][4][6] Group 1: Trial Results - In the ongoing Phase 2 AMPLIFY-7P trial, 89 out of 90 evaluable patients exhibited robust mKRAS-specific T cell responses [1][4] - The average fold change in T cell response was 145.3x, with a median fold change of 44.3x and a range from 2.13x to 1310x [3][4] - The T cell response rate was 99% in the Phase 2 trial compared to 100% in the Phase 1 trial, which included only MRD+ patients [3][4] Group 2: Clinical Correlation - T cell immune responses in the ELI-002 trials were significantly correlated with clinical activity in minimal residual disease positive (MRD+) patients [2][5] - The Phase 1 ELI-002 2P trial indicated that an mKRAS-specific T cell response of approximately 9x over baseline correlated with delayed relapse or death in MRD+ patients [5] Group 3: Future Prospects - The final disease-free survival analysis for the AMPLIFY-7P trial is anticipated in the fourth quarter of 2025, which could support the expansion of ELI-002 to a broader patient population [2][6] - Elicio's AMP technology aims to enhance the education and activation of cancer-specific T cells, potentially leading to durable cancer immunosurveillance [12][10] Group 4: Product Overview - ELI-002 is a novel investigational Amphiphile cancer vaccine targeting KRAS mutations, which are prevalent in many cancers [8][12] - The ELI-002 7P formulation is designed to provide immune response coverage against seven common KRAS mutations, increasing the potential patient population [9][12]

Core Insights - Elicio Therapeutics published follow-up data from the Phase 1 AMPLIFY-201 study in Nature Medicine, demonstrating that over two-thirds of participants with T cell responses exceeding the antitumor efficacy threshold had significantly reduced risks of relapse or death [1][5][11] Group 1: Study Results - At a median follow-up of 19.7 months, median overall survival (OS) increased from 16.33 months to 28.94 months [5][11] - A 77% reduction in the risk of death and an 88% reduction in the risk of relapse were associated with T cell responses above the efficacy threshold [5][11] - Direct ex vivo mKRAS-specific T cell responses were observed in 84% of patients, with both CD4+ and CD8+ T cell responses in 71% of patients [6][11] - Antigen-spreading was observed in 67% of patients, indicating a broader immune response beyond the targeted mKRAS antigens [11] Group 2: Clinical Implications - The updated data supports the potential of the AMP platform to provide durable benefits to pancreatic ductal adenocarcinoma (PDAC) patients in the adjuvant setting [3][5] - The final event-driven disease-free survival (DFS) analysis for the ongoing Phase 2 AMPLIFY-7P study is anticipated in Q4 2025 [5][6] Group 3: Technology and Future Directions - Elicio's AMP platform aims to enhance the education, activation, and amplification of cancer-specific T cells, potentially leading to improved clinical outcomes compared to conventional vaccination strategies [9][14] - ELI-002 targets the most common KRAS mutations, which drive approximately 25% of all solid tumors, and is being studied in patients with mKRAS-positive pancreatic and colorectal cancers [9][12] - Future plans include expanding ELI-002 to other indications, such as mKRAS-positive lung cancer [9][12]

[PART I FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This section presents unaudited interim financial statements and management's analysis of financial condition and operations [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Financial statements reveal significant net losses and negative operating cash flows, raising substantial doubt about going concern - The Company has experienced net losses and negative cash flows from operating activities since inception, with an accumulated deficit of **$215.9 million** as of June 30, 2025. This, along with the need for additional capital, raises substantial doubt about its ability to continue as a going concern[32](index=32&type=chunk)[33](index=33&type=chunk) Key Financial Highlights (Unaudited) | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :--------------------------------------------- | :--------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Research and development expenses | $7,006 | $8,180 | $14,784 | $15,739 | | General and administrative expenses | $3,085 | $2,744 | $6,043 | $5,426 | | Total operating expenses | $10,091 | $10,924 | $20,827 | $21,165 | | Loss from operations | $(10,091) | $(10,924) | $(20,827) | $(21,165) | | Total other (expense) income, net | $(470) | $3,695 | $(943) | $2,109 | | Net loss | $(10,561) | $(7,229) | $(21,770) | $(19,056) | | Net loss per common share, basic and diluted | $(0.66) | $(0.64) | $(1.50) | $(1.77) | [Condensed Consolidated Balance Sheets (unaudited)](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20%28unaudited%29) Cash and equivalents increased, liabilities decreased from debt conversion, shifting stockholders' equity to positive Condensed Consolidated Balance Sheet Data (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :----------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $22,088 | $17,618 | | Total current assets | $22,598 | $20,693 | | Total assets | $29,528 | $28,178 | | Total current liabilities | $9,923 | $11,523 | | Long-term debt, net | $9,337 | $20,034 | | Total liabilities | $27,694 | $39,490 | | Total stockholders' equity (deficit) | $1,834 | $(11,312) | [Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20%28unaudited%29) Net loss increased for both periods, driven by decreased R&D, increased G&A, and a shift in other expense, net Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------ | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Research and development | $7,006 | $8,180 | $14,784 | $15,739 | | General and administrative | $3,085 | $2,744 | $6,043 | $5,426 | | Total operating expenses | $10,091 | $10,924 | $20,827 | $21,165 | | Loss from operations | $(10,091) | $(10,924) | $(20,827) | $(21,165) | | Change in fair value of warrant liabilities | $(859) | $3,616 | $(1,366) | $2,338 | | Grant income | $415 | — | $415 | — | | Net loss | $(10,561) | $(7,229) | $(21,770) | $(19,056) | | Net loss per common share, basic and diluted | $(0.66) | $(0.64) | $(1.50) | $(1.77) | [Condensed Consolidated Statements of Stockholders' Equity (Deficit) (unaudited)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity%20%28Deficit%29%20%28unaudited%29) Stockholders' equity improved from deficit to positive, driven by debt conversion and equity offerings, despite net loss Changes in Stockholders' Equity (Deficit) (in thousands) | Item | Six Months Ended June 30, 2025 Impact | | :---------------------------------------------------- | :----------------------------------- | | Balance as of December 31, 2024 | $(11,312) | | Conversion of senior note payable into common stock | $20,176 | | Issuance of common stock and warrants (January 2025 Offering) | $9,143 | | Issuance of common stock (At-the-Market offering) | $2,016 | | Issuance of common warrants (June 2025 Promissory Note) | $641 | | Stock-based compensation | $1,227 | | Net loss | $(21,770) | | Balance as of June 30, 2025 | $1,834 | [Condensed Consolidated Statements of Cash Flows (unaudited)](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20%28unaudited%29) Financing activities significantly increased cash, offsetting operating outflows and leading to a net increase in cash and equivalents Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(19,069) | $(21,050) | | Net cash used in investing activities | — | $(39) | | Net cash provided by financing activities | $22,260 | $11,340 | | Net increase (decrease) in cash | $3,296 | $(9,790) | | Cash, cash equivalents and restricted cash at end of period | $22,788 | $4,511 | - Key financing activities for the six months ended June 30, 2025, included **$9.1 million** from the January 2025 Offering, **$9.9 million** from the June 2025 Promissory Note Financing, and **$2.9 million** from At-the-Market offerings[154](index=154&type=chunk) [Notes to Unaudited Interim Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Interim%20Condensed%20Consolidated%20Financial%20Statements) Notes disclose business, accounting policies, and financial instruments, highlighting going concern uncertainty and recent debt activities - The Company's accumulated deficit of **$215.9 million** and negative operating cash flows raise substantial doubt about its ability to continue as a going concern, necessitating additional financing[32](index=32&type=chunk)[33](index=33&type=chunk) - In March 2025, the Company converted a **$20.0 million** Senior Secured Convertible Promissory Note into **3,500,573 shares** of common stock[100](index=100&type=chunk)[114](index=114&type=chunk) - In June 2025, the Company issued a new **$10.0 million** Senior Secured Promissory Note to GKCC, along with warrants to purchase **103,225 shares** of common stock, generating net proceeds of **$9.9 million**[101](index=101&type=chunk)[102](index=102&type=chunk)[103](index=103&type=chunk)[115](index=115&type=chunk)[116](index=116&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, emphasizing significant net losses, negative cash flows, and ongoing going concern uncertainty - Elicio Therapeutics is a clinical-stage biotechnology company developing immunotherapies for cancer, with its lead candidate ELI-002 7P in a Phase 2 study for mKRAS-driven pancreatic cancer[119](index=119&type=chunk)[122](index=122&type=chunk) - The Company's cash on hand is projected to fund operations only into the first quarter of 2026, necessitating additional capital through equity, debt, or strategic transactions to continue as a going concern[124](index=124&type=chunk)[127](index=127&type=chunk)[149](index=149&type=chunk) Operating Expense and Net Loss Trends (in thousands) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | % Change (YoY) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | % Change (YoY) | | :-------------------------------- | :--------------------------- | :--------------------------- | :------------- | :--------------------------- | :--------------------------- | :------------- | | Research and Development | $7,006 | $8,180 | (14)% | $14,784 | $15,739 | (6)% | | General and Administrative | $3,085 | $2,744 | 12% | $6,043 | $5,426 | 11% | | Total Operating Expenses | $10,091 | $10,924 | (8)% | $20,827 | $21,165 | (2)% | | Net Loss | $(10,561) | $(7,229) | 46% | $(21,770) | $(19,056) | 14% | [Overview](index=25&type=section&id=Overview) Elicio Therapeutics, a clinical-stage biotech, develops cancer immunotherapies, with lead candidate ELI-002 7P in Phase 2, facing going concern doubts - Elicio's AMP technology aims to generate robust anti-tumor T cell responses by preferentially targeting lymph nodes, addressing limitations of current immunotherapies[119](index=119&type=chunk)[120](index=120&type=chunk) - ELI-002 7P, a lead cancer immunotherapy vaccine, is in a Phase 2 study for mKRAS-driven pancreatic cancer, targeting seven KRAS mutations in **88%** of PDAC patients. An interim review confirmed a favorable safety profile, and the trial will continue to final analysis in Q4 2025[122](index=122&type=chunk) - The Company's net loss was **$10.6 million** and **$21.8 million** for the three and six months ended June 30, 2025, respectively, with an accumulated deficit of **$215.9 million** and **$22.1 million** in cash and cash equivalents as of June 30, 2025[123](index=123&type=chunk) - Substantial doubt exists about the Company's ability to continue as a going concern, with current cash expected to fund operations only into the first quarter of 2026, necessitating additional financing[124](index=124&type=chunk)[127](index=127&type=chunk) [Components of Results of Operations](index=27&type=section&id=Components%20of%20Results%20of%20Operations) Operating expenses (R&D, G&A) are expected to increase with clinical trials and public company operations, impacting other income/expense - Research and development expenses include personnel costs, consultant fees, sponsored research, manufacturing of clinical materials, and laboratory expenses, all expensed as incurred[132](index=132&type=chunk)[135](index=135&type=chunk) - R&D expenses are expected to increase substantially due to ongoing clinical trials, manufacturing, and advancing product candidates, with significant uncertainties regarding timing and costs to complete development[134](index=134&type=chunk)[136](index=136&type=chunk)[137](index=137&type=chunk) - General and administrative expenses are projected to increase due to additional personnel, legal, regulatory, accounting, and investor relations costs associated with operating as a public company[138](index=138&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) R&D decreased, G&A increased, and other income shifted to expense for both periods, contributing to a higher net loss Operating Expenses and Other Income/Expense (in thousands) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | $ Change | % Change | | :-------------------------------- | :--------------------------- | :--------------------------- | :------- | :------- | | Research and development | $7,006 | $8,180 | $(1,174) | (14)% | | General and administrative | $3,085 | $2,744 | $341 | 12% | | Total other (expense) income, net | $(470) | $3,695 | $(4,165) | (113)% | | Net loss | $(10,561) | $(7,229) | $(3,332) | 46% | Operating Expenses and Other Income/Expense (Six Months) (in thousands) | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | $ Change | % Change | | :-------------------------------- | :--------------------------- | :--------------------------- | :------- | :------- | | Research and development | $14,784 | $15,739 | $(955) | (6)% | | General and administrative | $6,043 | $5,426 | $617 | 11% | | Total other (expense) income, net | $(943) | $2,109 | $(3,052) | (145)% | | Net loss | $(21,770) | $(19,056) | $(2,714) | 14% | - The decrease in R&D expenses was primarily due to less clinical trial manufacturing for ELI-002 7P, while the increase in G&A expenses was driven by higher professional fees related to the June 2025 Promissory Note Financing and January 2025 Offering[141](index=141&type=chunk)[142](index=142&type=chunk)[145](index=145&type=chunk)[146](index=146&type=chunk) - The significant decrease in other (expense) income was mainly due to the change in fair value of liability-classified common warrants and the one-time grant income recognized in the prior year[143](index=143&type=chunk)[147](index=147&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) The Company raised **$205.2 million** since inception but faces going concern doubts, with cash funding operations only into Q1 2026, requiring future financing - Since inception, the Company has raised **$205.2 million** from various financing activities, including common stock, warrants, convertible notes, and promissory notes[148](index=148&type=chunk) - Net cash used in operating activities was **$19.1 million** for the six months ended June 30, 2025, an improvement from **$21.1 million** in the prior year, primarily due to non-cash charges and changes in operating assets and liabilities[151](index=151&type=chunk)[152](index=152&type=chunk) - Net cash provided by financing activities was **$22.3 million** for the six months ended June 30, 2025, driven by proceeds from the January 2025 Offering (**$9.1 million**), June 2025 Promissory Note Financing (**$9.9 million**), and At-the-Market offerings (**$2.9 million**)[154](index=154&type=chunk) - The Company anticipates significant future expenditures for product candidate development and will require additional financing, with no assurance of availability on acceptable terms, which could lead to delays or termination of development efforts[149](index=149&type=chunk)[157](index=157&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=32&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) Financial statements adhere to U.S. GAAP, relying on estimates, with no material changes to critical accounting policies since the last Form 10-K - The preparation of financial statements requires management to make estimates and assumptions that impact reported asset and liability amounts and expenses[158](index=158&type=chunk) - No material changes occurred in the Company's critical accounting policies and estimates during the six months ended June 30, 2025, compared to those in the Form 10-K[159](index=159&type=chunk) [Emerging Growth Company and Smaller Reporting Company Status](index=32&type=section&id=Emerging%20Growth%20Company%20and%20Smaller%20Reporting%20Company%20Status) Elicio qualifies as an emerging growth and smaller reporting company, benefiting from reduced JOBS Act reporting and extended accounting transition - The Company is an emerging growth company and a smaller reporting company, benefiting from reduced reporting requirements under the JOBS Act[160](index=160&type=chunk) - Elicio has elected to use the extended transition period for complying with new or revised accounting standards, which may result in financial statements not being comparable to companies that adopt standards earlier[161](index=161&type=chunk) - The Company will remain an emerging growth company until the earliest of December 31, 2026, achieving **$1.235 billion** in annual gross revenue, becoming a large accelerated filer, or issuing over **$1.0 billion** in non-convertible debt[162](index=162&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Elicio Therapeutics is exempt from market risk disclosures - The Company is exempt from providing quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company[164](index=164&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective, having remediated prior material weaknesses in complex transaction evaluation and financial reporting - The Company's disclosure controls and procedures were evaluated as effective as of June 30, 2025[166](index=166&type=chunk)[167](index=167&type=chunk) - Previously identified material weaknesses related to insufficient resources for complex transactions and financial reporting controls have been fully remediated as of June 30, 2025[168](index=168&type=chunk)[171](index=171&type=chunk) - Remediation measures included engaging SEC compliance and technical accounting consultants, hiring additional finance and accounting personnel, and strengthening financial reporting and expense accrual processes with enhanced data capture and review procedures[169](index=169&type=chunk)[170](index=170&type=chunk) [PART II OTHER INFORMATION](index=35&type=section&id=PART%20II%20OTHER%20INFORMATION) This section provides additional information on legal proceedings, risk factors, equity sales, defaults, and exhibits [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The Company is not involved in legal proceedings expected to have a material adverse effect on its business - As of the report date, the Company does not believe it is a party to any claim, proceeding, or litigation that would individually or in aggregate have a material adverse effect on its business[173](index=173&type=chunk) [Item 1A. Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) Investing in the Company's common stock involves high risk, with no material changes to risk factors since the Form 10-K - Investing in the Company's common stock carries a high degree of risk[175](index=175&type=chunk) - No material changes to risk factors have occurred since the Form 10-K, except as noted in the prior quarterly report[175](index=175&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported - No unregistered sales of equity securities or use of proceeds occurred[177](index=177&type=chunk) [Item 3. Defaults Upon Senior Securities](index=37&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The Company reported no defaults upon senior securities - No defaults upon senior securities were reported[178](index=178&type=chunk) [Item 4. Mine Safety Disclosures](index=37&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The Company has no mine safety disclosures to report - No mine safety disclosures are applicable[179](index=179&type=chunk) [Item 5. Other Information](index=37&type=section&id=Item%205.%20Other%20Information) No Rule 10b5-1(c) trading arrangements were adopted, modified, or terminated by directors or executive officers - No Rule 10b5-1(c) trading arrangements were adopted, modified, or terminated by directors or executive officers during the quarter[180](index=180&type=chunk) [Item 6. Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed, including June 2025 Promissory Note Financing agreements and executive officer certifications - Key exhibits include the Senior Secured Promissory Note, Note Purchase Agreement, Security Agreement, IP Security Agreement, and Subsidiary Guarantee related to the June 2025 Promissory Note Financing[181](index=181&type=chunk) - Certifications from the Principal Executive Officer and Principal Financial Officer pursuant to Sarbanes-Oxley Act Sections 302 and 906 are included[181](index=181&type=chunk) [Signatures](index=39&type=section&id=Signatures) The report was duly signed by the President and CEO, and the Chief Strategy and Financial Officer - The report was signed by Robert Connelly, President and CEO, and Preetam Shah, Chief Strategy and Financial Officer, on August 7, 2025[186](index=186&type=chunk)

Core Insights - Elicio Therapeutics received a positive recommendation from the Independent Data Monitoring Committee (IDMC) to continue the ELI-002 7P randomized Phase 2 study in pancreatic cancer without modifications, indicating preliminary efficacy signals [2][8] - The final analysis focused on disease-free survival (DFS) is expected in Q4 2025, with plans to advance to a pivotal Phase 3 trial following the analysis [2][8] - The company secured $10 million in financing in Q2 2025, extending its cash runway into Q1 2026, beyond the anticipated final DFS analysis [2][7] Recent Highlights - The R&D expense for Q2 2025 was $7.0 million, a decrease from $8.2 million in Q2 2024, primarily due to reduced clinical trial manufacturing [4] - General and administrative expenses increased to $3.1 million in Q2 2025 from $2.7 million in Q2 2024, attributed to higher professional fees related to financing [5] - The net loss for Q2 2025 was $10.6 million, compared to $7.2 million in Q2 2024, with a net loss per share of $0.66 versus $0.64 in the prior year [6] Financial Position - As of June 30, 2025, cash and cash equivalents were $22.1 million, an increase from $17.6 million at the end of 2024 [10] - Total current assets amounted to $22.6 million, while total liabilities were $27.7 million, resulting in total stockholders' equity of $1.8 million [10] Upcoming Milestones - The company anticipates the DFS event-driven final analysis of the Phase 2 AMPLIFY-7P clinical trial in Q4 2025 [8] - Following the final analysis, Elicio plans to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the pivotal Phase 3 trial of ELI-002 [2][8]

Core Insights - Elicio Therapeutics announced that the Independent Data Monitoring Committee (IDMC) recommended the continuation of the Phase 2 AMPLIFY-7P trial for ELI-002 7P without modifications, indicating preliminary efficacy signals [1][5] - The final disease-free survival (DFS) analysis is expected in Q4 2025, and the company plans to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the Phase 3 study [2][5] - ELI-002 7P is an investigational immunotherapy targeting seven KRAS mutations, which are prevalent in 88% of PDAC patients and 25% of all solid tumors [3][8] 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 utilizes its proprietary Amphiphile (AMP) technology to enhance the immune response against cancer, aiming for durable cancer immunosurveillance [4][9] - ELI-002 is designed as an off-the-shelf vaccine candidate targeting common KRAS mutations, with potential benefits including low cost and rapid availability for patients [4][6] Clinical Trial Details - The AMPLIFY-7P trial is a 2:1 randomized, open-label study involving 144 patients across 24 U.S. sites, comparing ELI-002 7P monotherapy to standard of care [2][5] - ELI-002 7P treatment consists of six doses followed by an eight-week observation period and four booster doses [2] - The trial aims to improve DFS in patients with PDAC who have undergone local therapy, surgery, and chemotherapy [2] Future Plans - Elicio plans to expand ELI-002 to other indications, including mKRAS-positive lung cancer and additional mKRAS-positive cancers [6] - The company is also developing other off-the-shelf therapeutic cancer vaccine candidates, such as ELI-007 and ELI-008, targeting BRAF-driven cancers and p53 hotspot mutations [6]

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.

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]

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].