Humacyte(HUMA) - 2025 Q2 - Quarterly Results

CEO Statement & Q2 Execution Summary The CEO reported significant progress in Symvess™ commercial launch, expanding hospital access and accelerating sales, alongside positive V007 trial data - The number of civilian hospitals eligible to purchase Symvess™ increased from 5 to 82 due to individual and healthcare system Value Analysis Committee (VAC) approvals[3] - Inclusion on the Electronic Catalog (ECAT) makes Symvess™ available to approximately 190 Military Treatment Facilities and U.S. Department of Veterans Affairs (VA) hospitals[3] - July 2025 product sales exceeded the total sales recorded during the first half of the year, and the first commercial sale to a U.S. military treatment facility was achieved[3] - The V007 trial data, highlighted by the Society of Vascular Surgery, showed superior functional patency for the ATEV™ over autologous fistula in key subgroups like women, and men with diabetes and obesity[3] Corporate Highlights This section details Symvess™ market expansion through hospital and military approvals and updates on ATEV™ Phase 3 clinical trials Symvess™ Market Launch Symvess™ market access expanded significantly through VAC and ECAT approvals, driving a sharp increase in July sales and initial military facility orders - A total of 13 Value Analysis Committees (VACs) have approved Symvess, making it available to 82 civilian hospitals, with an additional 40 VACs currently in the review process[4] - July 2025 product sales reached $0.3 million, exceeding the total sales recorded during the first half of the year. To date, 12 hospitals have ordered Symvess[4][5] - ECAT listing was granted in July 2025, making Symvess available to approximately 35 Military Treatment Facilities and 160 VA hospitals[8] ATEV™ in Dialysis Clinical Trials Positive V007 Phase 3 results showed superior ATEV™ patency, while the V012 study reached 100 patients, enabling interim analysis and a potential BLA submission - Results from the V007 Pivotal Phase 3 trial, presented at VAM25, showed significantly higher functional and secondary patency for ATEV recipients in a high-risk cohort compared to the AV fistula control group[8] - The V012 Phase 3 clinical trial has enrolled 100 patients, achieving the threshold for a planned interim analysis when the first 80 patients reach one-year follow-up[8] - Humacyte plans to submit a supplemental Biologics License Application (BLA) in H2 2026 to expand the Symvess label for AV access in hemodialysis, subject to interim results from the V012 study[8] Financial Performance This section provides an overview of Humacyte's financial results, including revenue, net loss, operating expenses, and cash position Second Quarter 2025 Financial Highlights Humacyte reported $0.3 million in Q2 2025 revenue, a narrowed net loss of $37.7 million, and maintained $88.4 million in cash Financial Highlights Table | Financial Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Total Revenue | $0.3M | $0 | | Product Revenue | $0.1M | $0 | | Contract Revenue | $0.2M | $0 | | Net Loss | ($37.7M) | ($56.7M) | - Selling, general and administrative (SG&A) expenses increased to $7.8 million from $5.7 million YoY, primarily due to the U.S. commercial launch of Symvess[9] - Research and development (R&D) expenses decreased to $22.0 million from $23.8 million YoY, mainly due to the capitalization of overhead costs for commercial manufacturing[9] - The company held $88.4 million in cash, cash equivalents, and restricted cash as of June 30, 2025[10] Cost Reduction Plan Humacyte implemented a cost reduction plan, including a 30-employee workforce reduction, projected to save over $50 million through 2026 - The company implemented a plan to reduce its workforce by 30 employees, defer new hires, and reduce other operating expenses[9] - A one-time cash expenditure of approximately $0.7 million for severance and termination benefits was incurred, with the majority recorded in Q2 2025[9] Estimated Net Savings from Cost Reduction Plan | Period | Estimated Net Savings | | :--- | :--- | | 2025 | ~$13.8 million | | 2026 | ~$38.0 million | | Total (2025-2026) | > $50 million | Consolidated Financial Statements This section presents detailed unaudited Condensed Consolidated Statements of Operations and Balance Sheets for the periods ended June 30, 2025 and 2024 Statements of Operations Humacyte reported $301,000 in Q2 2025 revenue with a $37.7 million net loss, while the six-month period showed $818,000 revenue and $1.5 million net income Three Months Ended June 30 (in thousands, except per share) | (in thousands, except per share) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Total revenue | $301 | $0 | | Loss from operations | ($29,727) | ($29,499) | | Net income (loss) | ($37,658) | ($56,663) | | Net income (loss) per share, basic | ($0.24) | ($0.48) | Six Months Ended June 30 (in thousands, except per share) | (in thousands, except per share) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Total revenue | $818 | $0 | | Loss from operations | ($52,911) | ($56,077) | | Net income (loss) | $1,481 | ($88,559) | | Net income (loss) per share, basic | $0.01 | ($0.78) | Balance Sheets As of June 30, 2025, total assets were $138.8 million, liabilities $134.7 million, and stockholders' equity improved to $4.1 million Balance Sheet Data (in thousands) | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $38,032 | $44,937 | | Total current assets | $51,730 | $47,859 | | Total assets | $138,795 | $137,872 | | Liabilities & Equity | | | | Total current liabilities | $21,085 | $19,954 | | Total liabilities | $134,743 | $190,541 | | Total stockholders' equity (deficit) | $4,052 | ($52,669) | Product Information & Disclosures This section provides essential information regarding Symvess™ indications, safety warnings, and standard forward-looking statement disclaimers Symvess™ Indication and Safety Information Symvess™ is indicated for urgent extremity revascularization, carrying a boxed warning for graft failure and risks like rupture, thrombosis, and anastomotic failure - Symvess is indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed and autologous vein graft is not feasible[12] - The product has a BOXED WARNING for graft failure, noting that loss of integrity can result in life-threatening hemorrhage[13] - Key warnings and precautions include graft rupture, anastomotic failure, and thrombosis. Anti-platelet therapy is recommended following treatment[15][16][17] Forward-Looking Statements This section includes standard forward-looking statements, subject to significant risks and uncertainties that may cause actual results to differ materially - The press release contains forward-looking statements concerning the commercialization of Symvess, market acceptance, manufacturing capabilities, clinical trial execution, and the timing of regulatory filings[22][23] - These statements are subject to numerous risks and uncertainties, and the company cautions that actual results may differ materially from those projected[23]