Durham, N.C. — November 12, 2025 — Humacyte, Inc. (NASDAQ: HUMA) reported third‑quarter results and a pipeline update this morning, highlighting accelerating Symvess™ sales, new clinical data in dialysis access, and a key regulatory step toward first‑in‑human testing of its coronary bypass graft. 1
- Revenue: $753,000 in Q3, including $703,000 from Symvess product sales; nine‑month 2025 revenue totaled $1.571 million. 1
- Earnings: GAAP EPS −$0.11 (net loss $17.5M), an improvement vs. last year; cash $19.8M at Sept. 30, plus ~$56.5M in net proceeds raised after quarter‑end. 1
- Commercial traction: 25 Value Analysis Committee approvals now cover 92 U.S. hospitals; 16 hospitals have ordered Symvess (most reordered). 1
- Dialysis program: Positive two‑year results from the V007 Phase 3 trial presented at Kidney Week 2025; V012 interim threshold reached, guiding a supplemental BLA planned for 2H 2026. 1
- Cardiac surgery program:IND has been submitted to the FDA for coronary artery bypass grafting (CABG) to enable a first‑in‑human study in 2026. 1
What Humacyte reported
Humacyte posted $753,000 in Q3 revenue—$703,000 from Symvess, the FDA‑approved acellular tissue‑engineered vessel (ATEV) for adult extremity vascular trauma, and ~$100,000 from a collaboration with a large med‑tech partner. Management emphasized a step‑up in VAC approvals and hospital onboarding as the key driver of the sales ramp. 1
On profitability, the company recorded GAAP EPS of −$0.11 (net loss $17.5M), narrower than the prior year, with R&D $17.3M and SG&A $7.6M. The balance sheet showed $19.8M in cash at quarter‑end; ~$56.5M of net proceeds were raised subsequently. 1
A faster sales cadence for Symvess
Since FDA approval in December 2024, Symvess has gradually moved into trauma centers, aided by Defense Logistics Agency ECAT listing and growing VAC throughput. As of today’s update, 25 VAC approvals now enable 92 civilian hospitals to purchase, and 16 hospitals have placed orders, most with reorders—evidence of early repeat use. 1
Context: Symvess is the first U.S.‑approved acellular tissue‑engineered vessel for urgent extremity arterial injury when autologous vein isn’t feasible. (FDA approval: Dec 20, 2024.) 2
Pipeline & clinical momentum
Dialysis access (ATEV for AV access)
Humacyte reported positive two‑year outcomes from its V007 Phase 3 trial, presented at Kidney Week 2025, showing superior duration of use vs autogenous fistula in high‑need subgroups. Alongside V012—where the interim analysis trigger (80 patients at one year) has been reached—the company plans a supplemental BLA in 2H 2026 to add dialysis access to the ATEV label, pending results. 1
Coronary bypass (CTEV / small‑diameter ATEV)
Preclinical data in non‑human primates published in JACC: Basic to Translational Science showed sustained flow, recellularization, and remodeling toward native artery size with the coronary tissue engineered vessel (CTEV). Humacyte says it has submitted an IND to the FDA aiming for a first‑in‑human CABG study in 2026. 3
Trauma & real‑world evidence
The company also pointed to recent publications, including real‑world Ukrainian wartime trauma experience and hospital‑acquired vascular complications showing high patency and limb salvage without conduit infections—supportive for clinicians evaluating Symvess in infected or contaminated fields. 1
By the numbers (and how they stack up)
- Q3 revenue: $0.753M vs $0.301M in Q2 2025 (≈+150% QoQ), reflecting Symvess ramp and collaboration revenue. 4
- Nine‑month revenue: $1.571M; Symvess contributed $0.9M YTD, collaborations $0.6M. 1
- EPS vs. expectations: Several trackers flagged a beat on EPS (−$0.11 vs ~−$0.16 consensus) with lighter revenue than some models. 5
Early headlines noted a pre‑market pop as investors digested the EPS beat; trading subsequently turned choppy as the session progressed. 6
Why this matters
Humacyte’s thesis rests on off‑the‑shelf, universally implantable vascular conduits that resist infection and undergo host recellularization—attributes highly relevant in contaminated trauma fields and potentially in dialysis access and cardiac surgery. With commercial sales gaining traction post‑approval and regulatory/clinical catalysts ahead (dialysis sBLA, CABG IND to FIH), the company’s 2025 narrative is shifting from development to adoption and label expansion. 2
Near‑term watchlist for investors & clinicians
- Dialysis V012 interim readout timing and details; clarity on the 2H 2026 supplemental BLA path. 1
- FDA feedback on the CABG IND and activation of a first‑in‑human CABG study in 2026. 1
- Hospital onboarding metrics: additional VAC approvals, order growth beyond the current 16 hospitals, and any military uptake via ECAT. 1
- Real‑world outcomes publications and registry data that could influence guidelines and purchasing decisions. 1
Sources (Nov 12, 2025 and recent)
- Q3 2025 press release & business update (revenues, Symvess sales, VACs/hospitals, cash, post‑quarter financing, dialysis & CABG plans). 1
- SEC Form 8‑K referencing today’s results release. 7
- Earnings coverage (EPS beat / revenue context). 5
- Additional coverage of Q3 results (RTT News/Nasdaq; Yahoo Finance). 8
- Dialysis two‑year data at Kidney Week 2025 (V007). 9
- CTEV preclinical data in JACC: Basic to Translational Science. 3
- FDA approval background for Symvess (Dec 20, 2024). 2
Disclosure: This article is for informational purposes only and does not constitute investment advice or a solicitation to buy or sell any securities.
