Humacyte(HUMA) - 2025 Q4 - Annual Report

Product Launch and Approvals - Humacyte, Inc. commenced the U.S. commercial launch of its first FDA-approved product, Symvess, in Q1 2025, targeting vascular trauma indications[16]. - The FDA granted full approval for Symvess on December 19, 2024, for use as a vascular conduit in urgent revascularization cases[20]. - The FDA granted full approval for ATEV on December 19, 2024, for use in adults with extremity vascular trauma, broadening its indication beyond previous restrictions[113]. - ATEV received RMAT designation from the FDA in May 2023 for urgent arterial repair following extremity vascular trauma, with a BLA filed in December 2023[81]. - The company expects to file a BLA with the FDA in the second half of 2026 for ATEV use in AV access for hemodialysis, targeting high-risk patients[48]. - The FDA is expected to receive a supplemental BLA submission in the second half of 2026, targeting subgroups with the best results from the ATEV[169]. Clinical Trials and Results - As of December 31, 2025, approximately 636 patients have received ATEVs in clinical trials and post-launch[19]. - The company is conducting a Phase 3 trial for a 6mm ATEV in AV access for hemodialysis, with plans to submit a supplemental BLA in H2 2026[21]. - ATEV has been implanted in over 85 clinical sites across seven countries with zero instances of clinical rejection in the past ten years[66]. - The longest ATEV use for dialysis has been more than ten years, with no evidence of clinically relevant immunologic reactions observed[65]. - In the V005 trial, the primary patency rate for ATEVs was 84.3%, compared to 78.9% for synthetic grafts, while secondary patency was 90.2% versus 78.9%[86]. - ATEV demonstrated a primary patency rate of 93.8% and a secondary patency rate of 93.8% in the V017 trial, with no conduit infections or amputations reported[99]. - The combined results from the V005 and V017 trials showed a primary patency of 87.1% and a secondary patency of 91.5%, significantly outperforming the synthetic graft benchmark of 78.9%[110]. - The V006 trial enrolled 355 subjects, with ATEV subjects trending older (mean age 62.6 years) and having a higher prior stroke rate (12.4%) compared to ePTFE subjects (5.6%)[138]. - ATEV demonstrated secondary patency rates of 92% at 6 months and 67% at 24 months, while ePTFE showed 87% and 74% respectively, indicating ATEV's initial advantage[142]. - The V007 trial enrolled 242 patients, comparing ATEV to autogenous AV fistulas, with ATEV showing functional patency of 81.3% at 6 months versus 66.4% for AVF[157]. - ATEV demonstrated a secondary patency rate of 68.3% at 12 months compared to AVF's 62.2%, with a duration of use of 7.5 months versus 6.1 months[157]. - The V012 trial has enrolled 113 patients, with an interim analysis planned after one year of follow-up, expected to report results in Q2 2026[168]. Manufacturing and Capacity - Humacyte's manufacturing facility spans 83,000 square feet and can accommodate over 40 LUNA200 systems, currently operating eight systems[35]. - The LUNA200 system can produce up to 200 ATEVs (42cm in length) per batch, with the ability to generate 400 ATEVs (13cm in length) per batch[36]. - The LUNA200 manufacturing system can produce up to 200 ATEVs per batch, with an annual gross capacity of approximately 900 ATEVs per system[215]. - The FDA inspected the manufacturing facility in April 2024, which is set to support the commercial launch of ATEVs in the first quarter of 2025[214]. Patient Population and Economic Impact - The estimated annual eligible patient population for ATEVs in the U.S. is approximately 26,000, based on trauma injury analysis[43]. - An estimated $5 to $6 billion per year is spent on hospital admissions for hemodialysis patients with infection and access complications, with over 555,000 patients receiving hemodialysis in the U.S. in 2024[46]. - Hemodialysis patients average 1.8 hospital admissions and four days hospitalized for infections each year, with infection and access complications being the two most common causes[47]. - The ATEVs are projected to be cost-saving for trauma centers and third-party payors, primarily due to reductions in costs related to amputations and conduit infections[45]. - A Budget Impact Model published in March 2025 projected cost savings for trauma centers and third-party payers due to reduced rates of amputations and conduit infections associated with ATEV[114]. Safety and Efficacy - The average infection rate for ATEVs in AV access trials is approximately 1.0% or less per patient-year, with rates in trauma and PAD trials ranging from 0% to 2%[67]. - ATEV showed a low infection rate of less than 1% per patient-year in hemodialysis access trials, indicating a significant improvement over traditional methods[129]. - ATEV had a significantly lower rate of vascular access site infections (0%) compared to ePTFE (2.8%), highlighting a safety advantage[148]. - ATEVs maintained an infection-free rate of 92.9% from months 3 to 36 in long-term follow-up studies[92]. - The company has observed consistent durability and a strong tolerability profile for ATEVs across various trials and programs[65]. - ATEV has shown strong patency rates and no reported infections in clinical studies for peripheral artery disease (PAD)[171]. Future Developments - The company plans to support an IND application for CABG using a small diameter ATEV in 2025, following preclinical testing[56]. - The company is planning to commence human clinical testing of the CTEV in CABG in the second half of 2026, pending FDA IND clearance[202]. - The engineered lung technology is being scaled up for human-sized organs, with gas exchange observed in studies with rodent models[212]. - The BVP product candidate can accommodate approximately 800,000 human pancreatic islets, potentially reversing diabetes and restoring glucose control[194]. - Preclinical studies showed that insulin-producing cells in the BVP survived for months post-implantation and continued to produce measurable insulin in the bloodstream[197]. - The CTEV demonstrated sustained patency in a baboon model of CABG, with all CTEVs maintaining blood flow throughout a six-month follow-up[199]. - The CTEV is being evaluated for use in pediatric heart surgery, with promising results published in October 2023 showing patency and blood flow for up to six months[205].