Humacyte Inc Navigates Challenges, Celebrates Milestones in Q2 2025 Earnings Call Highlights

Humacyte Inc (HUMA) reported FDA approval for Symvess, expanding hospital eligibility and recording its first US military sale. However, the company faced challenges from unsubstantiated public attacks and CMS declining to approve the new technology add-on payment. Despite increased sales, Humacyte Inc reported a net loss of $37.7 million and reduced its workforce by 30 employees to align with business objectives and extend its cash runway.

Humacyte Inc. (HUMA) reported significant progress in expanding the commercial access for its Symvess product, following FDA approval for extremity vascular trauma. The company announced that 13 organizations have completed the Value Analysis Committee (VAC) process, resulting in 82 civilian hospitals now eligible to purchase Symvess [1]. This represents a substantial increase from the 5 hospitals eligible at the last quarterly earnings call. Additionally, the product's ECAT listing has made it available to 35 military treatment facilities and 160 VA hospitals, expanding the total number of eligible facilities to over 200 [2].

Despite these advancements, the company faced challenges from unsubstantiated public attacks and a CMS denial of the new technology add-on payment (NTAP) for Symvess. Humacyte CEO Laura Niklason acknowledged these headwinds but emphasized that the commercial impact of the NTAP denial is limited, as only about 4.3% of vascular trauma patients are covered under Medicare reimbursement [1]. The company is continuing discussions with private payers for supplemental reimbursement.

July product sales of approximately $0.3 million exceeded the total sales recorded for the first half of the year. Humacyte's CFO, Dale Sander, reported $0.3 million in Q2 revenue, with $0.1 million from U.S. Symvess sales and $0.2 million from a research collaboration. The company also implemented cost-saving initiatives, including a workforce reduction of 30 employees, to align with business objectives and extend its cash runway. Sander highlighted that the company is on track to achieve $38 million in savings in 2026, with a total estimated savings of over $50 million in 2025 and 2026 relative to the original budget forecast [1].

Humacyte aims to complete enrollment of 150 patients in the V012 Phase III trial for dialysis access by year-end 2025, with interim analysis planned for April 2026. The company is also planning to submit a supplemental BLA in the second half of 2026, including data from V012 and the V007 Phase III pivotal studies to expand the Symvess label and add AV access for hemodialysis as an indication [1].

Despite the challenges, Humacyte remains confident in its ability to drive value through disciplined cost controls, expanding hospital reach, and clinical pipeline momentum. The company is focused on executing commercial contracts, advancing clinical trials, and securing broader reimbursement as primary levers for growth through the remainder of 2025 and beyond.

References:
[1] https://seekingalpha.com/news/4483244-humacyte-targets-over-200-hospital-access-points-for-symvess-as-vac-approvals-surge-and-cost
[2] https://investors.humacyte.com/news-releases/news-release-details/humacyte-announces-second-quarter-2025-financial-results-and