Humacyte, Inc. (HUMA) Earnings

Management highlights

- Pipeline and Clinical Development Progress * Presented statistically significant positive top-line interim results from the VO-12 Phase 3 trial of ATEV for dialysis access in female patients at the vascular annual meeting: ATEV-treated patients achieved 91 more catheter-free days than the standard-of-care AV fistula (p=0.0007), meeting the trial's primary endpoint. Infection rates were 6 per 100 patient years for ATEV vs 23 for AV fistula. * Combined with prior positive data from the VO7 Phase 3 trial, management believes ATEV is the most significant advance in hemodialysis access in decades. The company plans to submit a supplemental BLA to the FDA for ATEV in dialysis access in H2 2026. * Two key industry experts (former Fresenius CMO Dr. Robert Kosman and former American Society of Nephrology president Dr. Prabir Roy Chowdhury) were added as advisors to support health economic, reimbursement, market access and medical education efforts ahead of the planned dialysis access launch. * The FDA accepted the company's IND application for first-in-human study of CTEV (a smaller-diameter derivative of ATEV) for coronary artery bypass grafting (CABG). The first commercial-scale manufacturing lot of CTEV has been completed, and the Phase 2a study is on track to initiate in Q3 2026. CTEV is the first new off-the-shelf CABG conduit to enter prospective clinical testing in the U.S. in over 40 years. - Commercial Transformation and CINVEST Launch Progress * A full commercial team rebuild was completed after Q2 2026, led by newly appointed Chief Commercial Officer Jim Mercadante (joined April 2026), to address prior slow adoption. The new team is built of members with deep, long-standing relationships in the vascular surgery space. * Revised introductory pricing incentives, professional education programs and value analysis committee engagement processes were implemented to drive adoption, creating a scalable framework to convert product interest into institutional approvals and sustained utilization. Influential hospitals have begun adopting CINVEST, and utilization is increasing, with positive surgeon feedback. * Israel's Ministry of Health accepted the company's marketing authorization application for CINVEST for arterial injury repair, with a scheduled 180-day review period leveraging existing FDA approval. * Dedicated U.S. DoD funding for evaluation of biological vascular repair for traumatic warfighter injuries is being leveraged, and the company is working with military leadership to expand access for U.S. service members. * Dr. Todd Rasmussen, a 28-year U.S. Air Force veteran and leading expert in vascular trauma repair, was appointed Chief Surgical Officer to lead peer-to-peer scientific support, medical education and clinical alignment.

Guidance

- The company remains on track to meet all its 2026 core goals: advancing the U.S. and global commercial launch of CINVEST, completing the VO12 Phase 3 pivotal trial of ATEV in dialysis access, submitting the supplemental BLA for the dialysis indication to the FDA in H2 2026, and initiating the first-in-human CTEV study in Q3 2026. - The supplemental BLA for ATEV dialysis access is targeted for submission in November 2026. Management plans to request priority review; if granted, a PDUFA date is expected in May 2027 with a launch targeted for the end of Q2 2027. If priority review is not granted, the PDUFA date would shift to August 2027. - Commercial adoption results from the CINVEST rebuild are expected to materialize in H2 2026, with 20 major U.S. health care systems currently in the process of adding CINVEST to their formularies by the end of 2026. - The CTEV Phase 2a study is expected to initiate in Q3 2026, after completing IRB review and site activation.

Segment performance

Humacyte reports only one core commercial product segment: CINVEST (Symbest) for vascular injury repair. In Q2 2026, commercial sales of the segment reached $0.4 million, up from $0.1 million in Q2 2025. For the first half of 2026, cumulative commercial sales were $0.9 million, compared to $0.2 million in the first half of 2025. No contract revenue was recorded in Q2 2026 or the first half of 2026, following completion of a prior-year research collaboration, compared to $0.2 million (Q2 2025) and $0.6 million (H1 2025) in contract revenue in the prior year period. Cost of goods sold for the segment was $1.2 million in Q2 2026 (vs $0.2 million Q2 2025), with only $0.2 million of this attributable to cost of units sold; the remainder was a $0.7 million inventory reserve and unused production capacity overhead. For H1 2026, cost of goods sold was $3.3 million (vs $0.4 million H1 2025), with $0.5 million attributable to cost of units sold, and $2.3 million attributable to inventory reserve and unused capacity expenses. R&D expenses were $8.1 million in Q2 2026 (vs $22.0 million Q2 2025) and $37.6 million H1 2026 (vs $37.4 million H1 2025). SG&A expenses were $8.0 million Q2 2026 (flat vs $7.8 million Q2 2025) and $16.0 million H1 2026 (flat vs H1 2025). Net loss was $36.8 million Q2 2026 (vs $37.7 million Q2 2025) and $54.4 million H1 2026 (vs net income of $1.5 million H1 2025, with the swing driven by non-cash remeasurement of contingent earn-out liabilities). As of June 30, 2026, the company held $80.3 million in cash, cash equivalents and restricted cash.

Risks & headwinds

- No explicit new material risks were discussed in the call. The standard forward-looking statement disclaimer notes that actual results could differ materially from expectations due to inherent risks and uncertainties, including clinical trial outcomes, FDA regulatory review timelines and outcomes, commercial adoption rates, and manufacturing constraints. Prior to the commercial team rebuild, the company underestimated the medical education required for the first-in-class product and lacked sufficient deep vascular surgery relationships among the commercial team, which slowed initial adoption of CINVEST.

Analyst Q&A

• Q: What challenges slowed early CINVEST commercial adoption, and what changes have been made that support expectations of a coming commercial inflection? /

  A: Management acknowledged adoption was slower than expected, as the company underestimated the degree of clinician education required for the first new vascular conduit in 40 years. The prior commercial team also lacked sufficient deep, established relationships with practicing vascular surgeons to drive adoption of the novel product. A full team rebuild was completed in three months, hiring new members with existing vascular surgery connections and experience launching new medical products, and streamlined value analysis approval processes and added introductory pricing incentives to make adoption easier. Early uptick in utilization is already visible after just a few months.

• Q: What is the status and expected timeline for the ATEV dialysis supplemental BLA, and what steps are being taken to de-risk submission and prepare for launch? /

  A: A pre-BLA meeting with the FDA is scheduled in the near term to finalize submission structure, and management does not expect any pushback on filing given the strength of the data, which includes over 1,000 patient years of cumulative exposure across completed trials. The company plans to use its existing RMAT designation and current approved indication to support its priority review request. Extensive preparation is ongoing to build a value and reimbursement story for CMS and private insurers, leveraging data showing ATEV reduces costly long-term catheter dependence for high-risk patients, generating measurable system-wide cost savings.

• Q: What is the commercial strategy for the ATEV dialysis indication, and will Fresenius play a leading role in the launch? /

  A: The current CINVEST commercial build is intentionally structured to prepare for the dialysis launch: gaining formulary access via the vascular injury indication means ATEV will already be on hospital shelves when the dialysis indication is approved, accelerating adoption. The company is preparing for launch day-one regardless of approval timing, and is evaluating multiple go-to-market strategies across different dialysis verticals, not just a partnership with Fresenius. Fresenius remains a key aligned partner (they receive royalties on all U.S. sales and have committed to adopt ATEV as standard of care for eligible patients), but the launch will be broader than only Fresenius.

• Q: Will CTEV clinical manufacturing strain existing commercial production capacity, and when will the CTEV trial start? /

  A: CTEV is manufactured on the same shared platform equipment as commercial ATEV, but the Phase 2a study only requires 10 patients, and the minimum production batch size is 100 vessels, so total production demand for CTEV over the next 1-2 years is very low and will not impact commercial output. IRB and site activation paperwork is underway following FDA IND approval, and the trial is expected to open for enrollment in the current month, with a focus on careful patient selection to generate high-quality initial data.