Humacyte (NASDAQ:HUMA) reported first-quarter 2026 Symvess sales of $0.5 million and outlined a series of commercial, clinical and cost-reduction initiatives aimed at accelerating adoption of its bioengineered vascular products.
On the company’s earnings call, President and Chief Executive Officer Dr. Laura Niklason said Humacyte’s main goals for 2026 include expanding the U.S. and global commercial launch of Symvess, completing the V012 Phase III pivotal trial of its acellular tissue engineered vessel, or ATEV, in dialysis access, filing a supplemental biologics license application with the U.S. Food and Drug Administration for the dialysis indication, and beginning a human study of its coronary tissue engineered vessel, or CTEV, in coronary artery bypass grafting.
Symvess sales rise, but company seeks faster adoption
Chief Financial Officer and Chief Corporate Development Officer Dale Sander said commercial sales of Symvess were $0.5 million, or 29 units, in the first quarter of 2026, compared with $0.1 million, or five units, in the first quarter of 2025.
Niklason said Humacyte has seen “expansion in the commercial uptake of Symvess,” but acknowledged that “more rapid product uptake and sales growth is necessary and is warranted based on Symvess’ tremendous potential.”
To support the launch, Humacyte recently added new commercial and clinical leadership. Niklason said the company hired medtech executive Jim Mercadante as chief commercial officer and Dr. Todd Rasmussen as chief surgical officer. She described Rasmussen as a leader in vascular surgery, vascular trauma and peripheral artery disease, and said he will help guide Symvess education efforts.
In response to an analyst question from Matt Miksic of Barclays, Niklason said it is still too early for Humacyte to provide 2026 revenue guidance, though she said she hopes to provide guidance by the end of the year. She said the company has restructured and strengthened its commercial team, with a more customer-focused approach aimed primarily at vascular and trauma surgeons.
“We have to provide better education on the technology,” Niklason said, adding that Humacyte also needs to help surgeons understand how the technology may benefit patients in the approved indication and potentially in future indications.
Niklason said Humacyte still has roughly 45 value analysis committee applications in various stages and continues working to get Symvess stocked in hospitals. However, she said simply getting the product on the shelf is not enough without additional surgeon support and education.
International expansion efforts continue
Humacyte is also pursuing international commercialization. Niklason said the company submitted a marketing authorization application to the Israeli Ministry of Health in March for Symvess in arterial injury repair, and the application was accepted for review in April. She said the ministry has set a 180-working-day review period.
The company also highlighted a $1.475 million purchase commitment for the Kingdom of Saudi Arabia. Niklason said that funding will support clinical evaluation and outreach programs in hospitals in the kingdom, alongside ongoing negotiations with a Saudi-based entity for a potential joint venture and license to commercialize Symvess in the country.
Sander said Humacyte’s amended agreement with Fresenius returned ex-U.S. rights to the company, creating additional opportunities outside the United States. He said Humacyte continues to advance efforts in the Middle East and has begun outreach related to potential partners in other major regions, including Europe and Japan.
Restructuring expected to save $14.3 million in 2026
Niklason said Humacyte implemented a workforce restructuring in May 2026, reducing total headcount by 45 employees, or roughly 25%, through staff reductions and deferral of planned hires. She said the company also trimmed other operating expenses, enabled by the completion of multiple technical and clinical projects over the past year.
Humacyte expects to incur approximately $0.8 million in one-time cash charges for severance and other termination benefits, with most of those costs expected in the second quarter of 2026. The company estimates the restructuring will generate approximately $14.3 million in net savings for the remainder of 2026.
In response to Ryan Zimmerman of BTIG, Sander said the savings are expected to be spread “relatively evenly” across the remainder of the year, particularly in the second half of 2026.
Dialysis access data expected in June
Niklason said Humacyte is nearing top-line interim results from its V012 Phase III trial in dialysis access. The study has enrolled 120 patients and is designed to compare the ATEV with arteriovenous fistulas in female patients. The company expects the interim results to be available around June 11, 2026, at the Vascular Annual Meeting in Boston.
If results are positive, Humacyte plans to submit a supplemental BLA in the second half of 2026 to add dialysis access as an indication for its ATEV.
During the question-and-answer session, Niklason said that if the pre-specified interim analysis shows clear superiority versus standard of care, the trial would stop under the protocol. She said the company would then analyze data from all enrolled and followed patients for inclusion in the supplemental BLA, along with data from the prior V007 study, which also compared the company’s vessel with fistula in catheter-dependent patients.
Niklason cautioned that she could not predict FDA decisions, but said the dialysis submission would involve the same product already approved in trauma. She said manufacturing, preclinical, safety and toxicology portions of the application are largely the same as those already reviewed by the FDA, leaving the clinical data as the main focus.
Asked by Joshua Jennings of TD Cowen about FDA interactions, Niklason said Humacyte has not had recent discussions with the agency on dialysis access, but previously discussed its V012 plan and intention to file a supplemental BLA if the trial is positive. She said the company would seek a pre-BLA meeting if the results are positive.
Pipeline and financial results
Humacyte also remains on track to begin a Phase I/II trial of CTEV in coronary artery bypass grafting in the second half of 2026, Niklason said. The company submitted an investigational new drug application to the FDA in late 2025 and has initiated the first large-scale manufacturing lot of CTEV in its commercial production facility. The CTEV product has a 3.5-millimeter diameter, smaller than the 6-millimeter vessels used in the limbs.
For the first quarter, Sander said contract revenue from a research collaboration with a large medical technology company was $2,000, down from $0.4 million in the prior-year period due to completion of that phase of the collaboration. Cost of goods sold were $2.0 million, compared with $0.1 million a year earlier, including $0.2 million tied to units sold and a $1.6 million inventory reserve.
Research and development expenses rose to $19.5 million from $15.4 million, driven by $4.3 million in material costs primarily related to non-commercial CTEV manufacturing runs and process improvements intended to improve future cost of goods sold. General and administrative expenses were $7.9 million, compared with $8.1 million in the first quarter of 2025.
Humacyte reported a net loss of $17.6 million for the quarter, compared with net income of $39.1 million in the prior-year period. Sander said the change was primarily due to lower non-cash income from remeasurement of the contingent earn-out liability. The company had cash, cash equivalents and restricted cash of $48.9 million as of March 31, 2026.
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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