ANGION BIOMEDICA(ANGN) - 2025 Q2 - Quarterly Report

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 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) 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] - 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] - 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] Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) 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] - 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][141][145] - 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][142][146] Condensed Consolidated Statements of Stockholders' Equity (Deficit) (unaudited) 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] - 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] Condensed Consolidated Statements of Cash Flows (unaudited) 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][151][152] - 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][154][155] - 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] Notes to Unaudited Interim Condensed Consolidated Financial Statements This section provides detailed explanations and additional information supporting the interim condensed consolidated financial statements Note 1—Description of the Business and Financial Condition 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] - 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][123] - 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][124] Note 2—Summary of Significant Accounting Policies 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] - The financial statements are prepared in accordance with U.S. GAAP and include wholly-owned subsidiaries, with all significant intercompany balances eliminated[37][38] - 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][41][42] Note 3—Fair Value Measurements 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] - 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] Note 4—Balance Sheet Components 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] - Accrued research and development expenses decreased from $4.910 million to $3.156 million[54] Note 5 — Research Grants 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] - 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] Note 6—Common Stock and Stockholders' Equity 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][59] - 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] - 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] - 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] Note 7—Stock-Based Compensation 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] - 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] Note 8—Warrants 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] - 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][81] - 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][83] | 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 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] - 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] - Future minimum annual maintenance payments under the license agreement are $0.1 million per year[92] Note 10—Leases 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] - 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] | 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 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] - 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] - The June 2025 Promissory Note is secured by a first priority lien on substantially all company assets and intellectual property[101] Note 12—Income Taxes 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] - A full valuation allowance is maintained against all deferred tax assets due to a history of cumulative net losses[104] - 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] Note 13—Net Loss Per Share 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] - 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][108] Note 14 —Related Party Transactions 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][110][113][115] - In March 2025, the Convertible Note held by GKCC was fully converted into 3,500,573 shares of common stock[114] - 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] Note 15 - Segment Reporting 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] | (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] - Chemistry, manufacturing and controls expenses decreased significantly to $1.030 million for H1 2025 from $3.058 million for H1 2024[117] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 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][120] - 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] - 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][124] - Cash on hand is projected to fund operations into the first quarter of 2026, with additional financing required to continue product development[124][127] 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 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] Item 4. Controls and Procedures 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][167] - 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][171] - Remediation measures included engaging SEC compliance consultants, hiring additional finance personnel, and strengthening financial reporting and expense accrual processes[169][170] 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 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] Item 1A. Risk Factors 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] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities or use of proceeds were reported during the period - None[177] Item 3. Defaults Upon Senior Securities No defaults upon senior securities were reported during the period - None[178] Item 4. Mine Safety Disclosures No mine safety disclosures were reported during the period - None[179] Item 5. Other Information 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] Item 6. Exhibits 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] - 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] - XBRL Instance Document and Taxonomy Extension Documents are provided for interactive data filing[181]