Humacyte Q2 Earnings Call Highlights

Key Points

• Dialysis expansion: Interim Phase III data showed ATEV patients had 91 more catheter-free days and fewer infections than those receiving standard AV fistulas. Humacyte plans to file a supplemental BLA with the FDA around November 2026, targeting a potential launch in mid-to-late 2027.
• Commercial rebuild: Second-quarter sales rose to $0.4 million from $0.1 million a year earlier as Humacyte revamped its SYMVESS sales strategy. At least 20 major U.S. health systems are working to adopt the product, while the company aims to expand access to roughly 1,000 additional hospitals.
• Pipeline and finances: The FDA accepted Humacyte’s application for a first-in-human coronary bypass study, with a 10-patient Phase IIa trial expected to begin in the current quarter. The company reported a $36.8 million quarterly net loss and ended June with $80.3 million in cash and restricted cash.

Humacyte NASDAQ: HUMA reported second-quarter commercial sales growth while outlining plans to expand adoption of its SYMVESS vascular repair product, submit a supplemental biologics license application for dialysis access and begin a first-in-human coronary bypass study.

Commercial sales totaled $0.4 million in the quarter ended June 30, up from $0.1 million a year earlier. Sales for the first six months of 2026 were $0.9 million, compared with $0.2 million in the prior-year period. The company reported a second-quarter net loss of $36.8 million, compared with a $37.7 million loss in the same quarter of 2025.

Dialysis Trial Results and Planned FDA Filing

President and Chief Executive Officer Dr. Laura Niklason said Humacyte presented interim data in June from its V012 Phase III trial of its Acellular Tissue Engineered Vessel, or ATEV, in female dialysis patients.

In a pre-specified interim analysis of the study’s first 80 patients, women receiving ATEV had 91 more catheter-free days than patients receiving an autologous arteriovenous fistula, the current standard of care. The company said the difference met the study’s primary efficacy endpoint, with a p-value of 0.0007.

Humacyte also reported six infections per 100 patient-years among ATEV patients, compared with 23 infections per 100 patient-years among patients who received an AV fistula. Niklason said the company believes the V012 findings, together with previously reported V007 Phase III results, could represent a significant advance in hemodialysis access.

The company plans to submit a supplemental BLA to the FDA for dialysis access during the second half of 2026. During the question-and-answer session, Niklason said Humacyte’s current target is a November filing and that the company intends to request priority review. If granted, she said the company would expect a PDUFA date around May 2027 and would target a launch near the end of the second quarter of 2027. Without priority review, the expected PDUFA date could extend into August, she said.

Humacyte has scheduled a pre-BLA meeting with the FDA, which Niklason said is expected to focus on the filing’s structure rather than whether the company can submit the application. She said the submission is expected to include data from three Phase III studies and several Phase II studies, representing more than 1,000 patient-years of exposure.

The company appointed Robert J. Kossmann, MD, and Prabir Roy-Chaudhury, MD, PhD, as advisors to support reimbursement, health economics and market-access planning for the prospective dialysis launch.

SYMVESS Commercial Rebuild

Chief Commercial Officer Jim Mercadante said the second quarter focused on rebuilding Humacyte’s commercial organization for SYMVESS, which is approved in the U.S. for extremity vascular injury repair.

Mercadante said the company remodeled its sales team to emphasize personnel with established vascular-surgery relationships, while refining introductory pricing programs, physician education and engagement with hospital value analysis committees. He said Humacyte is beginning to see increased utilization and adoption at hospitals during the second half of 2026.

Niklason said the company had underestimated the education needed to introduce a new vascular conduit to surgeons. She also said Humacyte needed commercial leaders with deeper relationships among practicing vascular surgeons.

Mercadante said Humacyte has at least 20 major U.S. healthcare systems in the process of bringing SYMVESS into their systems during the second half of the year. He said the systems range in size from roughly five to 50 hospitals. The company also hired an executive to develop a national-account strategy intended to expand access to approximately 1,000 hospitals where Humacyte previously lacked access.

Humacyte’s marketing authorization application for SYMVESS in acute injury repair was accepted for review by Israel’s Ministry of Health in April. The ministry established a 180-working-day review period, according to the company.

The company also appointed Dr. Todd Rasmussen as chief surgical officer. Rasmussen, a former U.S. Air Force vascular surgeon, will provide scientific support, medical education and technical guidance to physicians, Humacyte said.

Coronary Bypass Program Advances

Humacyte said the FDA accepted its investigational new drug application for a first-in-human study of its Coronary Tissue Engineered Vessel, or CTEV, in coronary artery bypass grafting. The CTEV is a smaller-diameter version of the company’s ATEV designed for bypass procedures.

The company completed its first large-scale manufacturing lot of CTEVs and plans to initiate a Phase IIa trial during the current quarter. Niklason said the study is expected to enroll 10 patients and could open during August, subject to completing institutional review board processes and related paperwork.

She said the CTEV study’s manufacturing needs are not expected to meaningfully affect production of commercial ATEV products because the trial requires relatively few vessels.

Financial Results

Cost of goods sold rose to $1.2 million in the second quarter from $0.2 million a year earlier. The company said $0.2 million was associated with units recognized as sales during the period, while the remainder primarily reflected a $0.7 million inventory reserve and expenses tied to unused production capacity.

Research and development expense fell to $8.1 million from $22 million, primarily due to reduced non-commercial manufacturing runs and lower clinical trial expenses. Selling, general and administrative expense was $8 million, compared with $7.8 million a year earlier.

For the first six months, Humacyte reported a net loss of $54.4 million, compared with net income of $1.5 million in the prior-year period. The company attributed the change primarily to non-cash remeasurement of its contingent earnout liability and other derivative liabilities.

Humacyte ended June with $80.3 million in cash equivalents and restricted cash. Total net cash provided during the first six months was $29.4 million, compared with net cash used of $6.9 million in the comparable 2025 period, driven by higher equity-sale proceeds and lower net cash used in operations.

About Humacyte (NASDAQ:HUMA)

Humacyte, Inc is a clinical-stage biotechnology company focused on the development and manufacturing of off-the-shelf, regenerative human acellular vessels (HAVs) designed to address critical vascular access needs. The company's proprietary vessels are engineered from human donor cells and then decellularized to create a biocompatible scaffold capable of integrating with a patient's own tissue. Humacyte's primary business activities encompass process development, large-scale manufacturing, and clinical evaluation of HAVs for use in end-stage renal disease, peripheral arterial disease and other vascular repair applications.

The company's lead product candidate, the HAV, has advanced through multiple clinical trials for arteriovenous access in hemodialysis patients, demonstrating durability, reduced infection rates and compatibility with repeated cannulation.

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