Humacyte Reports $148.7 Million Net Loss for 2024, FDA Approves Symvess™

Humacyte, Inc., a commercial-stage biotechnology company, reported a net loss of $148.7 million for the year ended December 31, 2024, a 34% increase compared to the $110.8 million loss in 2023. Operating expenses totaled $114.4 million in 2024, a 14% increase year-over-year, driven by increased research and development and general and administrative costs. The company attributed the rise in research and development expenses to expanded initiatives, including increased product manufacturing and support for FDA review of the Biologics License Application (BLA). General and administrative expenses increased due to preparations for the commercial launch of Symvess™.

A significant development was the FDA's full approval on December 19, 2024, of Symvess™ (acellular tissue engineered vessel-tyod or ATEV™) for use in adults as a vascular conduit for extremity arterial injury requiring urgent revascularization to prevent imminent limb loss when autologous vein graft is not feasible. The company commenced the U.S. commercial launch of Symvess™ in the first quarter of 2025. As of December 31, 2024, approximately 601 patients worldwide had received Humacyte's ATEVs in clinical trials, expanded access, and humanitarian programs. The company also reported positive topline results from its V007 Phase 3 trial for ATEV use in arteriovenous (AV) access for hemodialysis, with plans to submit a supplemental BLA in the second half of 2026, pending interim results from the V012 Phase 3 trial.

Humacyte's manufacturing capacity currently stands at approximately 7,200 ATEVs annually, utilizing eight LUNA200™ systems. The company has plans to expand this capacity to over 40 systems. The company's commercialization strategy for vascular repair and replacement applications involves a direct sales and marketing team within the United States, while collaborations with strategic partners are being pursued for other markets. A Budget Impact Model, published in March 2025, projected cost savings for trauma centers and third-party payers associated with Symvess™ due to reduced amputations and infections. A New Technology Add-On Payment (NTAP) application for Symvess™ was submitted to CMS in October 2024.

The company's product pipeline includes ongoing Phase 3 and Phase 2 trials for ATEVs in AV access for hemodialysis and peripheral artery disease (PAD), respectively. Preclinical development is underway for applications in coronary artery bypass grafting (CABG), pediatric heart surgery, and pancreatic islet cell transplantation for Type 1 diabetes (BioVascular Pancreas™ or BVP™). Humacyte employs 220 full-time employees as of December 31, 2024. The company's patent portfolio comprises 15 families of patents, many relating to ATEV scaffolds, composition, and manufacturing methods.

Humacyte's outlook anticipates continued operating losses for the foreseeable future, with funding needs dependent on commercial sales of Symvess™, regulatory approvals for additional indications, and the successful development and commercialization of its product candidates. The company plans to finance operations through existing cash and cash equivalents, equity or debt sales, credit facilities, collaborations, strategic transactions, and government grants. As of March 31, 2025, the company had $44.9 million in cash and cash equivalents, $50.4 million in restricted cash, and recently raised approximately $46.6 million in net proceeds from a public offering. The company acknowledged significant risks associated with its business, including competition, regulatory approvals, market acceptance, and manufacturing challenges, as detailed in the 10-K filing's "Risk Factors" section.