Humacyte, Inc.

Commercial sales were $0.4 million in Q2 2026 versus $0.1 million in Q2 2025; for the first six months of 2026, commercial sales were $0.9 million versus $0.2 million in the prior-year period. There was no contract revenue in Q2 or the first half of 2026, versus $0.2 million and $0.6 million in the comparable 2025 periods. Cost of goods sold was $1.2 million in Q2 2026 versus $0.2 million in Q2 2025, and $3.3 million for the first half versus $0.4 million a year ago. R&D expense was $18.1 million in Q2 2026 and $37.6 million for the first half, versus $22.0 million and $37.4 million in 2025; SG&A was $8.0 million in Q2 and $16 million for the first half, in line with last year. Other net expense was $9.8 million in Q2 and net income was $1.5 million for the first half, compared with a $7.9 million net expense and $54.5 million of other net income in the 2025 periods, mainly due to non-cash remeasurement of contingent earn-out and derivative liabilities. Net loss was $36.8 million in Q2 2026 and $54.4 million for the first half, versus a $37.7 million net loss in Q2 2025 and net income of $1.5 million in the first half of 2025. Cash, cash equivalents, and restricted cash were $80.1 million at June 30, 2026. Management reiterated a second-half 2026 sBLA filing target for dialysis access, with a possible May 2027 PDUFA and end-of-Q2 2027 launch if priority review is granted; if not, timing could slip to August for PDUFA.

Laura Niklason framed the quarter as a turning point across both the pipeline and commercialization. She highlighted the V012 interim dialysis data as a breakthrough for women and said the company is preparing a second-half 2026 sBLA filing, while also noting FDA acceptance of the CTEV IND and plans to begin the CABG Phase IIa study in the current quarter. Her tone was notably upbeat and confident, but she also acknowledged that the company underestimated the education and relationship-building needed for a novel vascular product.

Dale Sander’s commentary focused on modest revenue, high operating spend, and the drivers of the quarter’s losses. He cited $0.4 million of Q2 commercial sales, $18.1 million of R&D, $8.0 million of SG&A, and $36.8 million of net loss, with cost of goods sold inflated by a $0.7 million inventory reserve and unused-capacity overhead. He also pointed to $80.1 million of cash, cash equivalents, and restricted cash at quarter-end and said total net cash provided was $29.4 million in the first six months of 2026, helped by higher equity-sale proceeds and lower operating cash use.

Analysts focused heavily on why Symvess adoption had been slower than hoped and what had changed under the new commercial team. Management said the main issues were an underestimated education burden for a first-in-class conduit and the need for deeper vascular-surgery relationships, and that the rebuilt team, pricing incentives, national accounts, and streamlined VAC process should show more clearly in the second half. Questions on dialysis centered on filing timing, label scope, RMAT/priority review, and Fresenius; management said the pre-BLA meeting is near-term, the filing target is November, and the intended label would target patients at elevated risk of fistula failure or non-maturation, including women and men with obesity or diabetes risk factors.