UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________________ FORM 10-Q _____________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 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 Registrant's telephone number, includ ...

PART I FINANCIAL INFORMATION This section provides the unaudited condensed consolidated financial statements and related notes, detailing the company's financial position, operations, cash flows, and significant accounting policies [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements and detailed notes, covering financial position, operations, cash flows, and significant accounting policies, while highlighting going concern doubts [Condensed Consolidated Balance Sheets (unaudited)](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20%28unaudited%29) This statement provides a snapshot of the company's assets, liabilities, and stockholders' equity at specific points in time, reflecting changes in financial position | | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $22,088 | $17,618 | | Total current assets | $22,598 | $20,693 | | Total assets | $29,528 | $28,178 | | **Liabilities and Stockholders' Equity (Deficit)** | | | | Total current liabilities | $9,923 | $11,523 | | Warrant liabilities | $3,821 | $2,828 | | Long-term debt, net | $9,337 | $20,034 | | Total liabilities | $27,694 | $39,490 | | Total stockholders' equity (deficit) | $1,834 | $(11,312) | - Total assets increased from **$28.178 million** at December 31, 2024, to **$29.528 million** at June 30, 2025. Cash and cash equivalents increased by **$4.47 million**[19](index=19&type=chunk) - Total liabilities decreased significantly from **$39.490 million** at December 31, 2024, to **$27.694 million** at June 30, 2025, primarily due to a reduction in long-term debt[19](index=19&type=chunk) - Stockholders' equity (deficit) improved from a deficit of **$(11.312) million** at December 31, 2024, to a positive equity of **$1.834 million** at June 30, 2025[19](index=19&type=chunk) [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) This statement details the company's revenues, expenses, and net loss over specific periods, reflecting operational performance and other comprehensive income/loss | (in thousands) | 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 | $0 | $415 | $0 | | Net loss | $(10,561) | $(7,229) | $(21,770) | $(19,056) | | Net loss per common share, basic and diluted | $(0.66) | $(0.64) | $(1.50) | $(1.77) | - Net loss increased to **$(10.561) million** for Q2 2025 from **$(7.229) million** for Q2 2024, and to **$(21.770) million** for H1 2025 from **$(19.056) million** for H1 2024[21](index=21&type=chunk) - Research and development expenses decreased by **$1.174 million** (**14%**) for Q2 2025 and **$0.955 million** (**6%**) for H1 2025, primarily due to less clinical trial manufacturing[21](index=21&type=chunk)[141](index=141&type=chunk)[145](index=145&type=chunk) - General and administrative expenses increased by **$0.341 million** (**12%**) for Q2 2025 and **$0.617 million** (**11%**) for H1 2025, mainly due to higher professional fees related to financing activities[21](index=21&type=chunk)[142](index=142&type=chunk)[146](index=146&type=chunk) [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) This statement outlines changes in the company's equity or deficit over specific periods, including common stock, additional paid-in capital, and accumulated deficit | (in thousands, except share amounts) | Balance as of Dec 31, 2024 | Balance as of June 30, 2025 | | :--- | :--- | :--- | | Common Stock (Shares) | 11,043,837 | 16,277,387 | | Common Stock (Amount) | $110 | $163 | | Additional Paid-in Capital | $183,004 | $217,762 | | Accumulated Deficit | $(194,101) | $(215,871) | | Total Stockholders' Equity (Deficit) | $(11,312) | $1,834 | - Total stockholders' equity (deficit) improved from a deficit of **$(11.312) million** at December 31, 2024, to a positive equity of **$1.834 million** at June 30, 2025[24](index=24&type=chunk) - The increase in equity was driven by the conversion of a senior note payable into common stock (**$20.176 million**), issuance of common stock and warrants from the January 2025 Offering (**$9.143 million**), and At-the-Market offerings (**$2.016 million**)[24](index=24&type=chunk) [Condensed Consolidated Statements of Cash Flows (unaudited)](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20%28unaudited%29) This statement reports the cash generated and used by the company across operating, investing, and financing activities over specific periods | (in thousands) | 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 | $0 | $(39) | | Net cash provided by financing activities | $22,260 | $11,340 | | Net increase (decrease) in cash and cash equivalents | $3,296 | $(9,790) | | Cash, cash equivalents and restricted cash at end of period | $22,788 | $4,511 | - Net cash used in operating activities decreased to **$19.1 million** for H1 2025 from **$21.1 million** for H1 2024[28](index=28&type=chunk)[151](index=151&type=chunk)[152](index=152&type=chunk) - Net cash provided by financing activities significantly increased to **$22.3 million** for H1 2025 from **$11.3 million** for H1 2024, driven by proceeds from the January 2025 Offering, June 2025 Promissory Note Financing, and At-the-Market offerings[28](index=28&type=chunk)[154](index=154&type=chunk)[155](index=155&type=chunk) - The company experienced a net increase in cash and cash equivalents of **$3.3 million** for H1 2025, compared to a net decrease of **$9.8 million** for H1 2024[28](index=28&type=chunk) [Notes to Unaudited Interim Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Interim%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and additional information supporting the interim condensed consolidated financial statements [Note 1—Description of the Business and Financial Condition](index=10&type=section&id=Note%201%E2%80%94Description%20of%20the%20Business%20and%20Financial%20Condition) This note describes the company's core business, financial position, and the going concern assessment due to accumulated deficits and cash burn - Elicio Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing immunotherapies for cancer patients with limited treatment options[31](index=31&type=chunk) - The company has an accumulated deficit of **$215.9 million** as of June 30, 2025, and expects continued operating losses and negative cash flows[32](index=32&type=chunk)[123](index=123&type=chunk) - As of June 30, 2025, cash and cash equivalents were **$22.1 million**. The company's financial condition raises substantial doubt about its ability to continue as a going concern, requiring additional financing[33](index=33&type=chunk)[124](index=124&type=chunk) [Note 2—Summary of Significant Accounting Policies](index=10&type=section&id=Note%202%E2%80%94Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and methods used in preparing the financial statements, including grant funding and consolidation - Grant funding for research and development is recognized as grant income when related qualifying expenses are incurred and conditions are met, treated as conditional, nonreciprocal contributions[35](index=35&type=chunk) - The financial statements are prepared in accordance with U.S. GAAP and include wholly-owned subsidiaries, with all significant intercompany balances eliminated[37](index=37&type=chunk)[38](index=38&type=chunk) - The company is evaluating the impact of recently issued accounting standards, including ASU No. 2023-09 (Income Taxes), ASU No. 2024-03 (Expense Disaggregation Disclosures), and ASU No. 2024-04 (Convertible Debt Instruments), which are not yet adopted[40](index=40&type=chunk)[41](index=41&type=chunk)[42](index=42&type=chunk) [Note 3—Fair Value Measurements](index=11&type=section&id=Note%203%E2%80%94Fair%20Value%20Measurements) This note details the fair value hierarchy and measurements applied to financial assets and liabilities, particularly warrant liabilities | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Financial Assets** | | | | Money market funds (Level 1) | $6,130 | $12,100 | | Total assets | $6,130 | $12,100 | | **Financial Liabilities** | | | | Warrant liability (Level 2 & 3) | $3,821 | $2,828 | | Total liabilities | $3,821 | $2,828 | - The fair value of warrant liabilities increased from **$2.828 million** at December 31, 2024, to **$3.821 million** at June 30, 2025[43](index=43&type=chunk) - For the three and six months ended June 30, 2025, the Company recognized a loss of **$0.9 million** and **$1.4 million**, respectively, in fair value remeasurement of liability-classified warrants[48](index=48&type=chunk) [Note 4—Balance Sheet Components](index=12&type=section&id=Note%204%E2%80%94Balance%20Sheet%20Components) This note provides disaggregated information on specific balance sheet accounts, including prepaid expenses, property and equipment, and accrued expenses | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Prepaid and Other Current Assets** | | | | Prepaid research and development contract services | $234 | $1,206 | | Total prepaid and other current assets | $510 | $1,897 | | **Property and Equipment, Net** | | | | Total property and equipment | $2,035 | $2,035 | | Less: accumulated depreciation | $(1,658) | $(1,552) | | Property and equipment, net | $377 | $483 | | **Accrued Expenses** | | | | Accrued research and development | $3,156 | $4,910 | | Total accrued expenses | $5,106 | $8,415 | - Prepaid research and development contract services decreased significantly from **$1.206 million** to **$0.234 million**[49](index=49&type=chunk) - Accrued research and development expenses decreased from **$4.910 million** to **$3.156 million**[54](index=54&type=chunk) [Note 5 — Research Grants](index=14&type=section&id=Note%205%20%E2%80%94%20Research%20Grants) This note describes the company's research grant agreements, including recognition of grant income and related R&D expenses - The company completed its third grant agreement with the GI Research Foundation in Q2 2025, recognizing the remaining **$0.4 million** of grant funds as grant income[58](index=58&type=chunk) - For the three and six months ended June 30, 2025, the company incurred **$0.3 million** and **$0.8 million** in R&D expenses related to the third grant, fully reimbursed from available funds[57](index=57&type=chunk) [Note 6—Common Stock and Stockholders' Equity](index=14&type=section&id=Note%206%E2%80%94Common%20Stock%20and%20Stockholders%27%20Equity) This note details changes in common stock and stockholders' equity, including share issuances, offerings, and conversions - The company's authorized common stock is **300,000,000 shares**, with **16,277,387 shares** issued at June 30, 2025[19](index=19&type=chunk)[59](index=59&type=chunk) - Under the 2024 ATM Program, the company issued **388,520 shares** of common stock for net proceeds of approximately **$2.9 million** during the six months ended June 30, 2025[62](index=62&type=chunk) - The January 2025 Offering resulted in net proceeds of **$9.2 million** from the issuance of **1,261,830 shares** of common stock and accompanying common warrants[66](index=66&type=chunk) - The June 2025 Promissory Note Financing involved the issuance of a **$10.0 million** Senior Secured Promissory Note and a warrant to purchase **103,225 shares** of common stock to GKCC[68](index=68&type=chunk) [Note 7—Stock-Based Compensation](index=16&type=section&id=Note%207%E2%80%94Stock-Based%20Compensation) This note provides information on stock-based compensation expense recognized and unrecognized compensation related to equity awards | (in thousands) | 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 | $262 | $140 | $491 | $276 | | General and administrative | $448 | $210 | $736 | $398 | | Total stock-based compensation expense | $710 | $350 | $1,227 | $674 | - Total stock-based compensation expense increased to **$0.710 million** for Q2 2025 from **$0.350 million** for Q2 2024, and to **$1.227 million** for H1 2025 from **$0.674 million** for H1 2024[71](index=71&type=chunk) - As of June 30, 2025, total unrecognized compensation expense related to unvested stock option awards was **$5.9 million**, to be recognized over approximately **2.85 years**[70](index=70&type=chunk) [Note 8—Warrants](index=17&type=section&id=Note%208%E2%80%94Warrants) This note details the classification, fair value, and changes in outstanding warrants, including their exercise prices and types - Certain outstanding warrants are classified as liabilities and measured at fair value, with changes recognized in the statements of operations[76](index=76&type=chunk) - The March 2024 Pre-Funded Warrants and July 2024 Pre-Funded Warrants held by GKCC and affiliates were reclassified to equity after Stockholder Approval in November 2024[78](index=78&type=chunk)[81](index=81&type=chunk) - The fair value of the January 2025 Common Warrants was **$9.7 million** at issuance, and the June 2025 Warrant was **$0.6 million** at issuance[82](index=82&type=chunk)[83](index=83&type=chunk) | Common Stock Warrants | Classification | Number of Warrants Outstanding | Weighted Average Exercise Price | | :--- | :--- | :--- | :--- | | Elicio Warrants | Equity-classified | 144,814 | $53.59 | | Angion Warrants | Liability-classified | 3,950 | $76.00 | | March 2024 Pre-Funded Warrants | Equity-classified | 1,032,702 | $0.01 | | July 2024 Pre-Funded Warrants | Equity-classified | 1,600,000 | $0.01 | | July 2024 Common Warrants | Liability-classified | 2,231,500 | $5.00 | | January 2025 Common Warrants | Equity-classified | 1,261,830 | $7.80 | | June 2025 Common Warrants | Equity-classified | 103,225 | $7.75 | | Total Warrants Outstanding at June 30, 2025 | | 6,378,021 | $4.69 | [Note 9—Commitments and Contingencies](index=19&type=section&id=Note%209%E2%80%94Commitments%20and%20Contingencies) This note discloses the company's legal proceedings, license agreement obligations, and future milestone and royalty payments - The company is not currently a party to any legal proceedings expected to have a material adverse effect on its business[88](index=88&type=chunk) - Under a license agreement, the company is required to pay up to **$20.9 million** upon achievement of certain late-stage developmental and commercial milestones, plus royalties on product sales[91](index=91&type=chunk) - Future minimum annual maintenance payments under the license agreement are **$0.1 million** per year[92](index=92&type=chunk) [Note 10—Leases](index=20&type=section&id=Note%2010%E2%80%94Leases) This note provides information on the company's operating lease for office and laboratory space, including lease terms and future payments - The company has an operating lease for office and laboratory space in Boston, expiring in February 2030, with total aggregate rent payments of **$11.1 million**[93](index=93&type=chunk) - Lease expense for all leases was **$0.3 million** for Q2 2025 and **$0.7 million** for H1 2025, a decrease from **$0.4 million** and **$0.8 million** respectively in 2024[94](index=94&type=chunk) | Year Ended December 31, | Amounts (in thousands) | | :--- | :--- | | 2025 (remaining six months) | $675 | | 2026 | $1,383 | | 2027 | $1,425 | | 2028 | $1,467 | | 2029 | $1,512 | | Thereafter | $253 | | Total | $6,715 | | Less present value discount | $(1,150) | | Operating lease liabilities | $5,565 | [Note 11 - Debt](index=21&type=section&id=Note%2011%20-%20Debt) This note details the company's debt instruments, including the conversion of a senior secured convertible note and the issuance of a new promissory note - In March 2025, the **$20.0 million** Senior Secured Convertible Promissory Note, plus **$0.3 million** in accrued interest, was converted into **3,500,573 shares** of common stock[100](index=100&type=chunk) - In June 2025, the company issued a **$10.0 million** Senior Secured Promissory Note to GKCC, maturing June 3, 2028, with an interest rate of Prime Rate plus **5.00%** (max **12.5%**)[101](index=101&type=chunk) - The June 2025 Promissory Note is secured by a first priority lien on substantially all company assets and intellectual property[101](index=101&type=chunk) [Note 12—Income Taxes](index=22&type=section&id=Note%2012%E2%80%94Income%20Taxes) This note explains the company's income tax position, including the absence of a tax provision and the valuation allowance against deferred tax assets - The company did not record a provision or benefit for income taxes for the three and six months ended June 30, 2025 or 2024[104](index=104&type=chunk) - A full valuation allowance is maintained against all deferred tax assets due to a history of cumulative net losses[104](index=104&type=chunk) - The company is evaluating the impact of the H.R. 1 Act (signed July 4, 2025) on federal tax provisions, but does not expect a material effect on its financial statements for the period ended June 30, 2025[105](index=105&type=chunk) [Note 13—Net Loss Per Share](index=22&type=section&id=Note%2013%E2%80%94Net%20Loss%20Per%20Share) This note presents the calculation of basic and diluted net loss per common share, considering potentially dilutive securities | (in thousands, except share and per share data) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net loss | $(10,561) | $(7,229) | $(21,770) | $(19,056) | | Weighted average common shares and pre-funded warrants outstanding | 16,059,423 | 11,284,853 | 14,513,586 | 10,779,389 | | Net loss per share, basic and diluted | $(0.66) | $(0.64) | $(1.50) | $(1.77) | - Basic and diluted net loss per common share was **$(0.66)** for Q2 2025, compared to **$(0.64)** for Q2 2024. For H1 2025, it was **$(1.50)** compared to **$(1.77)** for H1 2024[107](index=107&type=chunk) - Potentially dilutive securities, including stock options and warrants, were anti-dilutive and thus not included in the diluted net loss per share calculation for all periods presented[106](index=106&type=chunk)[108](index=108&type=chunk) [Note 14 —Related Party Transactions](index=23&type=section&id=Note%2014%20%E2%80%94Related%20Party%20Transactions) This note discloses significant transactions with related parties, including financing activities involving a board member's controlled entity - GKCC, an entity controlled by a board member, participated in several financing activities, including the March 2024 Private Placement (**$6.0 million** net proceeds), the August 2024 Senior Secured Convertible Note Financing (**$19.7 million** net proceeds), and the June 2025 Senior Secured Promissory Note Financing (**$9.9 million** net proceeds)[109](index=109&type=chunk)[110](index=110&type=chunk)[113](index=113&type=chunk)[115](index=115&type=chunk) - In March 2025, the Convertible Note held by GKCC was fully converted into **3,500,573 shares** of common stock[114](index=114&type=chunk) - Board members Yekaterina Chudnovsky and Jay Venkatesan (and affiliated trusts) purchased July 2024 Pre-Funded Warrants and accompanying Common Warrants as part of the Public Offering[111](index=111&type=chunk) [Note 15 - Segment Reporting](index=24&type=section&id=Note%2015%20-%20Segment%20Reporting) This note clarifies that the company operates as a single reportable segment focused on developing cancer immunotherapies and provides disaggregated R&D expenses - The company operates as a single reportable segment focused on developing immunotherapies for cancer[117](index=117&type=chunk) | (in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Clinical trial expenses | $3,245 | $3,245 | $7,438 | $5,547 | | Employee related research and development expenses | $2,326 | $1,910 | $4,623 | $4,152 | | Chemistry, manufacturing and controls expenses | $384 | $1,864 | $1,030 | $3,058 | | Other research and development expenses | $1,316 | $1,439 | $2,452 | $3,326 | | Contract and grant reimbursements | $(265) | $(278) | $(754) | $(344) | | Employee related general and administrative expenses | $1,362 | $959 | $2,449 | $1,878 | | Professional fees and other general and administrative expenses | $1,723 | $1,786 | $3,589 | $3,548 | | Other segment items | $470 | $(3,696) | $943 | $(2,109) | | Segment net loss | $10,561 | $7,229 | $21,770 | $19,056 | - Clinical trial expenses increased to **$7.438 million** for H1 2025 from **$5.547 million** for H1 2024[117](index=117&type=chunk) - Chemistry, manufacturing and controls expenses decreased significantly to **$1.030 million** for H1 2025 from **$3.058 million** for H1 2024[117](index=117&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) This section discusses the company's financial condition, operational results, and liquidity, highlighting significant losses, going concern doubts, and the need for additional financing to support immunotherapy development - Elicio Therapeutics is a clinical-stage biotechnology company focused on immunotherapies for cancer, utilizing its proprietary Amphiphile (AMP) technology to target lymph nodes and stimulate T cell responses[119](index=119&type=chunk)[120](index=120&type=chunk) - The lead product candidate, ELI-002 7P, is in a Phase 2 study for mKRAS-driven pancreatic cancer, with the IDMC recommending continuation to final analysis and confirming a favorable safety profile[122](index=122&type=chunk) - The company had an accumulated deficit of **$215.9 million** and **$22.1 million** in cash and cash equivalents as of June 30, 2025, leading to substantial doubt about its ability to continue as a going concern[123](index=123&type=chunk)[124](index=124&type=chunk) - Cash on hand is projected to fund operations into the first quarter of 2026, with additional financing required to continue product development[124](index=124&type=chunk)[127](index=127&type=chunk) Operating Results Comparison (Three Months Ended June 30) | (in thousands) | 2025 | 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $7,006 | $8,180 | $(1,174) | (14)% | | General and administrative | $3,085 | $2,744 | $341 | 12% | | Total operating expenses | $10,091 | $10,924 | $(833) | (8)% | | Loss from operations | $(10,091) | $(10,924) | $833 | (8)% | | Total other (expense) income, net | $(470) | $3,695 | $(4,165) | (113)% | | Net loss | $(10,561) | $(7,229) | $(3,332) | - | Operating Results Comparison (Six Months Ended June 30) | (in thousands) | 2025 | 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $14,784 | $15,739 | $(955) | (6)% | | General and administrative | $6,043 | $5,426 | $617 | 11% | | Total operating expenses | $20,827 | $21,165 | $(338) | (2)% | | Loss from operations | $(20,827) | $(21,165) | $338 | (2)% | | Other (expense) income, net | $(943) | $2,109 | $(3,052) | (145)% | | Net loss | $(21,770) | $(19,056) | $(2,714) | - | Summary Statement of Cash Flows (Six Months Ended June 30) | (in thousands) | 2025 | 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) Operating activities | $(19,069) | $(21,050) | | Investing activities | $0 | $(39) | | Financing activities | $22,260 | $11,340 | | Effect of foreign currency on cash | $105 | $(41) | | Net increase (decrease) in cash | $3,296 | $(9,790) | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Elicio Therapeutics, Inc. is exempt from providing quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[164](index=164&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with previously identified material weaknesses fully remediated - As of June 30, 2025, the company's disclosure controls and procedures were evaluated and concluded to be effective[166](index=166&type=chunk)[167](index=167&type=chunk) - Previously identified material weaknesses related to insufficient resources for complex transactions and inadequate financial reporting/close controls for expense accruals 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 consultants, hiring additional finance personnel, and strengthening financial reporting and expense accrual processes[169](index=169&type=chunk)[170](index=170&type=chunk) PART II OTHER INFORMATION This section provides additional information not covered in the financial statements, including legal proceedings, risk factors, and other disclosures [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any 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) No material changes to risk factors have occurred since the last annual report, except as previously disclosed in the Q1 2025 10-Q - No material changes in risk factors from the Form 10-K, except as described in the Q1 2025 10-Q[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 during the period - None[177](index=177&type=chunk) [Item 3. Defaults Upon Senior Securities](index=37&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported during the period - None[178](index=178&type=chunk) [Item 4. Mine Safety Disclosures](index=37&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) No mine safety disclosures were reported during the period - None[179](index=179&type=chunk) [Item 5. Other Information](index=37&type=section&id=Item%205.%20Other%20Information) No directors or executive officers adopted, modified, or terminated Rule 10b5-1 trading arrangements during the fiscal quarter ended June 30, 2025 - No directors or executive officers adopted, modified, or terminated any Rule 10b5-1(c) trading arrangements during the fiscal quarter ended June 30, 2025[180](index=180&type=chunk) [Item 6. Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including financing agreements, executive certifications, and XBRL data - Exhibits include the Form of 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 Sections 302 and 906 of the Sarbanes-Oxley Act of 2002 are included[181](index=181&type=chunk) - XBRL Instance Document and Taxonomy Extension Documents are provided for interactive data filing[181](index=181&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________________ FORM 10-Q _____________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 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. (Exact name of ...

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 ...

Financial Performance - 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, reflecting a 76.5% increase in losses[19]. - The company reported a comprehensive loss of $18,802,000 for the three months ended September 30, 2024, compared to a comprehensive loss of $10,681,000 for the same period in 2023, an increase of 75.8%[19]. - For the nine months ended September 30, 2024, the company reported a net loss of $37.894 million, compared to a net loss of $26.246 million for the same period in 2023[26]. - The net loss for the three months ended September 30, 2024, was $18.8 million, compared to a net loss of $10.7 million for the same period in 2023, representing a 76.5% increase[154]. - The basic and diluted net loss per share for the three months ended September 30, 2024, was $(1.39), compared to $(1.27) for the same period in 2023[143]. - Net loss for the nine months ended September 30, 2024, was $37.9 million, compared to a net loss of $26.2 million in the same period of 2023[181]. Assets and Liabilities - Total current assets increased to $30,646,000 as of September 30, 2024, compared to $16,348,000 as of December 31, 2023, representing an increase of 87.5%[17]. - Total liabilities rose significantly to $57,374,000 as of September 30, 2024, from $15,773,000 as of December 31, 2023, marking an increase of 264.5%[17]. - The company’s accumulated deficit increased to $180,097,000 as of September 30, 2024, from $142,203,000 as of December 31, 2023, an increase of 26.7%[17]. - The company had an accumulated deficit of $180.1 million as of September 30, 2024[31]. - The company’s total liabilities included a warrant liability of $23.18 million as of September 30, 2024, with no transfers made among the fair value hierarchy levels during the reporting periods[78]. Cash Flow and Financing - Cash and cash equivalents increased to $26,016,000 as of September 30, 2024, from $12,894,000 as of December 31, 2023, a growth of 102.5%[17]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $28.324 million, compared to $22.799 million for the same period in 2023[26]. - The company reported a net increase in cash and cash equivalents of $13.726 million for the nine months ended September 30, 2024[26]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $42.1 million, resulting from various financing activities including a $19.7 million convertible note issuance[187]. - The company expects to finance operations through the sale of common stock or other securities, debt financings, or strategic collaborations[190]. Research and Development - Research and development expenses for the nine months ended September 30, 2024, were $22,947,000, up from $17,692,000 in the same period of 2023, indicating a 29.5% increase[19]. - Research and development expenses for the three months ended September 30, 2024, were $7.2 million, a decrease of 1% from $7.3 million in the same period of 2023[172]. - The company incurred $2.2 million in research and development expenses related to a grant agreement for the nine months ended September 30, 2024[92]. - The clinical pipeline includes ELI-002, ELI-007, and ELI-008, targeting specific oncogenic driver mutations, with ELI-002 currently in a Phase 2 clinical program[153]. Stock and Equity - The weighted average common shares outstanding for the three months ended September 30, 2024, were 13,582,345, compared to 8,376,384 for the same period in 2023, an increase of 62.5%[19]. - The company’s additional paid-in capital rose to $161,355,000 as of September 30, 2024, from $153,827,000 as of December 31, 2023, an increase of 4.9%[17]. - The total number of outstanding stock options increased to 1,860,954 as of September 30, 2024, with a weighted average exercise price of $15.87[111]. - The total unrecognized compensation expense related to unvested stock option awards was $3.5 million, expected to be recognized over approximately 2.43 years[112]. - The company has authorized 300 million shares of common stock and 10 million shares of preferred stock as per its current Amended and Restated Certificate of Incorporation[95]. Merger and Acquisitions - The company completed a reverse merger with Angion Biomedica Corp. on June 1, 2023, resulting in approximately 9.7 million shares of common stock outstanding[29]. - Following the merger, Former Elicio equity holders owned approximately 65.2% of the company on a fully diluted basis[29]. - The merger between Former Elicio and Angion was completed on June 1, 2023, with Former Elicio being the accounting acquirer, resulting in the issuance of 5,375,751 shares of Angion common stock to Former Elicio stockholders[73]. - The company recognized net assets acquired from the merger, totaling $32.13 million, which included cash and cash equivalents of $24.00 million and other current assets of $540,000[76]. Internal Controls and Compliance - The company identified material weaknesses in internal control over financial reporting, including insufficient resources with knowledge of U.S. GAAP[209]. - Remediation efforts for identified material weaknesses are ongoing, but have not been fully remediated as of September 30, 2024[210]. - The effectiveness of the internal control over financial reporting is subject to inherent limitations, providing only reasonable assurance rather than absolute assurance[211]. - The company is engaging SEC compliance and technical accounting consultants to ensure conformity with U.S. GAAP[212]. - Additional finance and accounting personnel are being hired to enhance resources for complex accounting matters and financial reporting[212]. Legal and Regulatory - There is no current litigation that is expected to have a material adverse effect on the business, although future litigation outcomes remain uncertain[215].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________________ FORM 10-Q _____________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 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. (Exact name of r ...

[PART I FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) This section presents Elicio Therapeutics, Inc.'s unaudited condensed consolidated financial statements for Q1 2024, including balance sheets, statements of operations, equity, and cash flows, along with explanatory notes [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance Sheet Summary (in thousands) | Account | March 31, 2024 (in thousands) | December 31, 2023 (in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $11,853 | $12,894 | | Total current assets | $14,130 | $16,348 | | Total assets | $24,480 | $27,146 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $5,951 | $9,755 | | Warrant liability | $7,868 | $11 | | Total liabilities | $19,610 | $15,773 | | Total stockholders' equity | $4,870 | $11,373 | - Total assets decreased from **$27.1 million** to **$24.5 million**, while total liabilities increased from **$15.8 million** to **$19.6 million**, primarily due to a significant increase in warrant liability. This resulted in a decrease in total stockholders' equity from **$11.4 million** to **$4.9 million**[19](index=19&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statement of Operations Summary (in thousands, except per share data) | Metric | Q1 2024 (in thousands) | Q1 2023 (in thousands) | | :--- | :--- | :--- | | Research and development | $7,559 | $5,484 | | General and administrative | $2,682 | $2,321 | | **Loss from operations** | **($10,241)** | **($7,805)** | | **Net loss** | **($11,827)** | **($8,029)** | | Net loss per common share | ($1.15) | ($24.77) | - Net loss increased to **$11.8 million** in Q1 2024 from **$8.0 million** in Q1 2023, driven by higher operating expenses and a **$1.3 million** charge for the change in fair value of warrant liability[21](index=21&type=chunk) [Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Equity%20(Deficit)) - Stockholders' equity decreased from **$11.4 million** at the end of 2023 to **$4.9 million** as of March 31, 2024. The decrease was primarily driven by a net loss of **$11.8 million**, partially offset by **$5.1 million** in net proceeds from an At-the-Market (ATM) common stock offering[23](index=23&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary (in thousands) | Activity | Q1 2024 (in thousands) | Q1 2023 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | ($12,122) | ($8,139) | | Net cash provided by (used in) investing activities | $3 | ($17) | | Net cash provided by financing activities | $11,024 | $10,040 | - Cash used in operations increased to **$12.1 million**. The company generated **$11.0 million** from financing activities, primarily from the issuance of common stock warrants (**$6.0 million**) and common stock (**$5.1 million**)[27](index=27&type=chunk) [Notes to Unaudited Interim Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Interim%20Condensed%20Consolidated%20Financial%20Statements) - **Going Concern:** The company's operating losses, negative cash flows, and an accumulated deficit of **$154.0 million** raise substantial doubt about its ability to continue as a going concern. Additional financing is required to fund operations for at least the next twelve months[32](index=32&type=chunk)[33](index=33&type=chunk) - **Reverse Merger:** On June 1, 2023, the company completed a reverse merger with Angion Biomedica Corp., which was accounted for as a reverse recapitalization with Former Elicio as the accounting acquirer[29](index=29&type=chunk)[30](index=30&type=chunk)[31](index=31&type=chunk) - **At-The-Market (ATM) Program:** During Q1 2024, the company sold **615,363 shares** of common stock under its ATM Program, generating net proceeds of approximately **$5.1 million**[95](index=95&type=chunk) - **Private Placement:** In March 2024, the company sold pre-funded warrants to purchase **1,032,702 shares** in a private placement, raising gross proceeds of approximately **$6.0 million**. These warrants are classified as a liability[96](index=96&type=chunk)[109](index=109&type=chunk)[130](index=130&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical-stage biotechnology focus, Q1 2024 financial results showing increased net loss, and critical liquidity concerns raising substantial doubt about its going concern ability - The company is a clinical-stage biotechnology company developing immunotherapies for cancer and infectious diseases using its proprietary Amphiphile (AMP) technology to target lymph nodes and generate robust T cell responses. Its lead candidate is ELI-002 for KRAS-mutated cancers[133](index=133&type=chunk)[134](index=134&type=chunk)[136](index=136&type=chunk) - **Going Concern and Liquidity:** The company has substantial doubt about its ability to continue as a going concern. As of March 31, 2024, it had **$11.9 million** in cash and cash equivalents, which is expected to fund operations only into the third quarter of 2024[142](index=142&type=chunk)[145](index=145&type=chunk)[147](index=147&type=chunk) Results of Operations Comparison (in thousands) | Expense Category | Q1 2024 (in thousands) | Q1 2023 (in thousands) | $ Change (in thousands) | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $7,559 | $5,484 | $2,075 | 38% | | General and administrative | $2,682 | $2,321 | $361 | 16% | | **Loss from operations** | **($10,241)** | **($7,805)** | **($2,436)** | **31%** | - The **$2.1 million** increase in R&D expenses was primarily due to advancing the ELI-002 clinical development. The **$0.4 million** increase in G&A expenses was due to higher personnel costs and professional fees associated with being a public company[160](index=160&type=chunk)[161](index=161&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures) As a smaller reporting company, Elicio Therapeutics is not required to provide the information for this item - The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information under this item[182](index=182&type=chunk) [Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were ineffective as of March 31, 2024, due to material weaknesses in internal control over financial reporting, with remediation efforts underway - Management concluded that the company's disclosure controls and procedures were not effective as of March 31, 2024, due to material weaknesses in internal control over financial reporting[186](index=186&type=chunk) - The identified material weaknesses relate to: (i) insufficient resources with U.S. GAAP expertise for complex transactions, (ii) insufficient financial reporting and closing controls, and (iii) insufficient review of financial reporting calculations like EPS[189](index=189&type=chunk) - A remediation plan is underway, including engaging consultants and hiring additional finance personnel, but the material weaknesses were not fully remediated as of March 31, 2024[190](index=190&type=chunk)[191](index=191&type=chunk) [PART II OTHER INFORMATION](index=35&type=section&id=PART%20II%20OTHER%20INFORMATION) [Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no awareness of any material legal proceedings as of the filing date - The Company is not aware of any material legal matters as of the filing date[114](index=114&type=chunk)[194](index=194&type=chunk) [Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) This section indicates no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K - There have been no material changes in the company's risk factors from those described in the Annual Report on Form 10-K filed on March 29, 2024[196](index=196&type=chunk) [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) The company reported no unregistered sales of equity securities or use of proceeds during the period - None reported for the quarter[198](index=198&type=chunk) [Defaults Upon Senior Securities](index=37&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None reported[199](index=199&type=chunk) [Mine Safety Disclosures](index=37&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[200](index=200&type=chunk) [Other Information](index=37&type=section&id=Item%205.%20Other%20Information) No directors or executive officers adopted, modified, or terminated Rule 10b5-1 trading plans during the fiscal quarter ended March 31, 2024 - During the quarter ended March 31, 2024, no directors or executive officers adopted, modified, or terminated any Rule 10b5-1 trading plans[201](index=201&type=chunk) [Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the Subscription Agreement, Pre-Funded Warrant form, and officer certifications - Exhibits filed include the Subscription Agreement dated March 18, 2024, the Form of Pre-Funded Warrant, and certifications from the Principal Executive Officer and Principal Financial Officer[203](index=203&type=chunk)

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, 2023 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 ...

[PART I FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) Q3 2023 financial statements reveal significant net losses, an accumulated deficit, and substantial doubt about going concern, influenced by R&D and a reverse merger [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance sheets show total assets increased to **$31.0 million** by September 30, 2023, driven by cash from a reverse merger, shifting from a stockholders' deficit to equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | September 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $14,841 | $6,156 | | Total current assets | $19,931 | $10,717 | | Total assets | $30,987 | $22,664 | | **Liabilities & Equity** | | | | Total current liabilities | $11,486 | $6,868 | | Total liabilities | $17,701 | $13,749 | | Total convertible preferred stock | $0 | $111,060 | | Total stockholders' equity (deficit) | $13,286 | $(102,145) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss increased to **$10.7 million** in Q3 2023 and **$26.2 million** for the nine months, primarily due to higher R&D and G&A expenses Operating Results (in thousands) | Metric | Q3 2023 | Q3 2022 | Nine Months 2023 | Nine Months 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $7,264 | $4,593 | $17,692 | $13,813 | | General and administrative | $3,507 | $1,177 | $8,661 | $3,959 | | Loss from operations | $(10,771) | $(5,770) | $(26,353) | $(17,772) | | Net loss | $(10,658) | $(7,198) | $(26,246) | $(21,557) | | Net loss per share | $(1.27) | $(22.67) | $(3.19) | $(68.52) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was **$22.8 million** for nine months, offset by **$31.6 million** from financing, primarily from a reverse merger and promissory notes Cash Flow Summary (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(22,798) | $(14,903) | | Net cash used in investing activities | $(32) | $(559) | | Net cash provided by financing activities | $31,611 | $10,026 | | **Net increase (decrease) in cash** | **$8,781** | **$(5,436)** | - Financing activities in 2023 were dominated by the reverse merger, which provided **$24.0 million** in cash, and proceeds from promissory notes of **$10.0 million**[28](index=28&type=chunk) [Notes to Unaudited Interim Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Interim%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the reverse merger, going concern doubt due to recurring losses, research grants, preferred stock conversion, and significant operating lease commitments - The company's financial condition, including an accumulated deficit of **$133.3 million** as of September 30, 2023, and the need for additional capital, raises substantial doubt about its ability to continue as a going concern[33](index=33&type=chunk)[34](index=34&type=chunk) - On June 1, 2023, the company completed a reverse merger with Angion Biomedica Corp., accounted for as a reverse recapitalization, acquiring net assets of **$32.1 million**, including **$24.0 million** in cash[31](index=31&type=chunk)[70](index=70&type=chunk)[74](index=74&type=chunk) - The company received research grant funding from the GI Research Foundation, including a **$2.8 million** award in 2022 and a new **$3.1 million** award in September 2023, with **$1.7 million** in grant funds available[86](index=86&type=chunk)[87](index=87&type=chunk) - A significant operating lease for office and laboratory space in Boston, expiring in January 2030, has total aggregate payments of **$11.1 million** and a liability of **$7.2 million** as of September 30, 2023[111](index=111&type=chunk)[114](index=114&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses ELI-002 clinical trials, increased operating expenses from R&D and G&A, and critical liquidity issues raising substantial doubt about going concern - The lead clinical program, ELI-002, a therapeutic cancer vaccine targeting KRAS mutations, plans to initiate a randomized phase 2 trial for the 7-peptide formulation (ELI-002 7P) in early 2024[126](index=126&type=chunk) Comparison of Operating Expenses (in thousands) | Expense Category | Q3 2023 | Q3 2022 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $7,264 | $4,593 | $2,671 | 58% | | General and administrative | $3,507 | $1,177 | $2,330 | 198% | | **Total operating expenses** | **$10,771** | **$5,770** | **$5,001** | **87%** | - The company has substantial doubt about its ability to continue as a going concern, with current cash of **$14.8 million** projected to fund operations only into the first quarter of 2024, requiring additional financing[130](index=130&type=chunk)[155](index=155&type=chunk)[157](index=157&type=chunk) - Net cash used in operating activities increased to **$22.8 million** for the first nine months of 2023 from **$14.9 million** in the same period of 2022, driven by a higher net loss[159](index=159&type=chunk)[160](index=160&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Elicio Therapeutics, Inc. is exempt from providing quantitative and qualitative disclosures about market risk - The company, as a smaller reporting company per Rule 12b-2 of the Exchange Act, is not required to provide market risk disclosures[171](index=171&type=chunk) [Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were ineffective as of September 30, 2023, due to an un-remediated material weakness in internal control over financial reporting - Management concluded that as of September 30, 2023, the company's disclosure controls and procedures were not effective[172](index=172&type=chunk) - The ineffectiveness stems from a material weakness in internal control over financial reporting, identified during the 2022 audit, related to accounting for complex transactions[173](index=173&type=chunk)[174](index=174&type=chunk) - Remediation efforts have been initiated but were not complete as of September 30, 2023[175](index=175&type=chunk) [PART II OTHER INFORMATION](index=38&type=section&id=PART%20II%20OTHER%20INFORMATION) [Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently aware of any material legal proceedings, though it may be involved in routine legal matters - The company is not aware of any material legal proceedings[116](index=116&type=chunk)[182](index=182&type=chunk) [Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) Updated risk factors highlight significant challenges in raising capital for going concern issues and the material weakness in internal control over financial reporting - The company faces significant challenges in raising capital for going concern issues due to difficult market conditions, early-stage programs, and limited stock trading volume, with potential for highly dilutive financing[185](index=185&type=chunk)[188](index=188&type=chunk) - A material weakness in internal controls over financial reporting, due to insufficient technical expertise for complex transactions, could lead to inaccurate financial reporting[186](index=186&type=chunk)[187](index=187&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=41&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported during the period - There were no unregistered sales of equity securities in the reported period[192](index=192&type=chunk) [Defaults Upon Senior Securities](index=41&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[193](index=193&type=chunk) [Mine Safety Disclosures](index=41&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - None[194](index=194&type=chunk) [Other Information](index=41&type=section&id=Item%205.%20Other%20Information) No directors or executive officers adopted, modified, or terminated Rule 10b5-1 trading plans during Q3 2023 - No directors or executive officers adopted, modified, or terminated any Rule 10b5-1 trading plans during the quarter ended September 30, 2023[195](index=195&type=chunk) [Exhibits](index=42&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including officer certifications, a separation agreement, and XBRL data files - Exhibits filed include officer certifications (31.1, 31.2, 32.1, 32.2), a separation agreement, the director compensation program, and XBRL interactive data files[196](index=196&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________________ FORM 10-Q _____________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 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. (Exact name of r ...