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Earnings

Humacyte Doubles Symvess Sales After Commercial Rebuild

Third-quarter Symvess sales reached $1.0 million, and the company said it anticipates at least doubling that total in the fourth quarter.

Humacyte, Inc. (HUMA), a commercial-stage biotechnology company developing bioengineered human tissues, more than doubled Symvess commercial sales in the third quarter after a second-quarter commercial rebuild, and said the momentum continued into October.

Commercial sales of the acellular tissue engineered vessel, approved in December 2024 for urgent extremity arterial injury, totaled $1.0 million in the three months ended September 30, 2026, a 151% increase from $0.4 million in the second quarter. The company said sequential growth and growth versus $0.7 million in the year-ago quarter resulted from commercialization initiatives implemented in the first half of 2026 and an increase in hospitals ordering the product.

Founder and Chief Executive Officer Laura Niklason said the company continued the transformation of the Symvess commercial program, doubling revenue over the second quarter and significantly increasing the number of hospitals ordering. Chief Commercial Officer Jim Mercadante said third-quarter sales achieved the goal set for the period.

Hospital adoption expanded with the number of hospitals that ordered Symvess rising 44% to 49 as of September 30, from 34 at the end of the second quarter. New hospital orders increased sequentially each month throughout the quarter.

October 2026 sales reached $0.8 million. Based on expanded hospital adoption and physician engagement, the company said it anticipates at least doubling third-quarter sales in the fourth quarter of 2026 and anticipates adding at least 20 new hospitals during the second half of 2026. Mercadante said the company has positioned Symvess for sustainable growth throughout the remainder of 2026 and beyond.

Total revenue was $1.03 million in the three months ended September 30, 2026, versus $0.75 million a year earlier. Product revenue was $1.02 million. Contract revenue was minimal at $0.005 million after the completion of a research project.

Cost of goods sold was $1.4 million, including $0.6 million of unit costs tied to sales and $0.8 million primarily of overhead related to unused production capacity and royalties. Research and development expenses were $14.1 million, $4.0 million less than the $18.1 million incurred in the second quarter. The company said the decrease versus the year-ago quarter was primarily due to a reduction in non-commercial manufacturing runs and the wind-down of certain programs. General and administrative expenses were $9.0 million, including $0.6 million of net expense related to a reserve for the settlement of shareholder litigation and related legal costs.

Net loss was $15.5 million, or $0.06 a share, compared with $17.5 million, or $0.11 a share, a year earlier. The company said the decrease was primarily related to lower research and development expenses. Cash, cash equivalents and restricted cash were $64.9 million as of September 30. Net cash used in operating activities was $15.0 million, versus $23.9 million a year earlier, which the company attributed primarily to lower inventory production costs.

In dialysis access, Humacyte said it plans to file a supplemental Biologics License Application with the FDA in November 2026 to add the indication, supported by three Phase 3 studies. Interim V012 results in women requiring hemodialysis access were presented at ASN Kidney Week in October; one-year V007 results were published in The Lancet Digital Health. The company appointed nephrologists Robert Kossmann and Prabir Roy-Chaudhury as advisors to prepare for planned dialysis commercialization if approved.

The FDA accepted an IND for a first-in-human study of the coronary tissue engineered vessel in coronary artery bypass grafting. Humacyte initiated a Phase 2a study in November 2026 with activation of the first clinical site and completed the first large-scale manufacturing lot of CTEV in commercial-scale production facilities.

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