Humacyte Q3 Earnings Call Highlights

Key Points

• Symvess sales gained momentum: Third-quarter sales were about $1 million, up 151% from the prior quarter, as ordering hospitals increased to 49 from 34. Humacyte expects sales to at least double in Q4 and at least 20 more hospitals to order by year-end.
• Dialysis-access filing is planned for November: Humacyte will seek FDA approval to expand ATEV use, supported by three Phase 3 studies. The company expects to learn in January whether the application is accepted and receives priority review; a decision could follow in May with priority review or September without it.
• The pipeline advanced while losses narrowed: Humacyte opened a Phase 2a study of its coronary tissue-engineered vessel and began screening patients. Q3 net loss narrowed to $15.5 million from $17.5 million a year earlier, and the company reported $64.9 million in cash, cash equivalents and restricted cash.

Humacyte NASDAQ: HUMA reported third-quarter Symvess sales of approximately $1 million, up 151% from the preceding quarter, and said it expects sales to at least double again in the fourth quarter as more hospitals adopt the product.

The company also plans to submit an application to the U.S. Food and Drug Administration later in November to expand use of its acellular tissue-engineered vessel, or ATEV, into dialysis access. Separately, Humacyte has initiated a first-in-human study of its coronary tissue-engineered vessel in patients undergoing coronary artery bypass grafting.

“I believe that the momentum that we have demonstrated this quarter, along with the upcoming filings and clinical trials, have set the stage for a very significant value creation story,” Founder and CEO Laura Niklason said on the earnings call.

Symvess sales gain as hospital adoption expands

Chief Commercial Officer Jim Mercadante said the number of hospitals ordering Symvess rose to 49 at the end of September from 34 at the end of June. October sales reached $800,000, he said, and the company expects at least 20 additional hospitals to order the product by year-end.

Mercadante attributed the progress to changes in the commercial team, marketing and training, as well as introductory pricing for some health systems. He said Humacyte’s average price for Symvess, or around its list price, is about $17,000 per unit, but declined to provide a specific third-quarter average selling price or unit volume.

Niklason said Humacyte is continuing to target busy trauma centers and vascular surgery practices for its existing vascular injury indication. An application for marketing authorization in Israel is under review, she added, and the company is examining other opportunities in the Middle East.

Dialysis filing planned for November

Humacyte’s planned supplemental biologics license application for dialysis access will be supported by three Phase 3 studies, Niklason said. In one of those studies, V012, women treated with ATEV achieved functional access for dialysis more than three months sooner and spent significantly more time free of dialysis catheters during the first year than women who received an arteriovenous fistula, she said.

The proposed indication has not been approved. Niklason said Humacyte intends to seek an indication covering all women and men with certain risk factors for fistula non-maturation.

After the submission, the FDA has 60 days to decide whether to accept the filing. Niklason said Humacyte expects to learn in January whether the agency accepts it and grants priority review. Under that scenario, an FDA decision could come in May, with a potential launch in June. Without priority review, she said, a decision could come in September, followed by a launch if approved.

Mercadante estimated the total U.S. dialysis market opportunity at $2 billion to $3 billion annually. He said existing relationships could help a potential launch because many vascular surgeons using Symvess for its current indication also perform dialysis access procedures.

Coronary study begins; financial losses narrow

Humacyte’s Phase 2a coronary vessel study is open and screening patients, Niklason said. The company has completed the first large-scale manufacturing lot of the investigational product for the study. She said preclinical results suggested it could be a potential off-the-shelf alternative to saphenous vein grafts.

The company reported a third-quarter net loss of $15.5 million, compared with $17.5 million a year earlier. Research and development expenses fell to $14.1 million from $17.3 million, primarily because of fewer noncommercial manufacturing runs and the wind-down of certain programs, Chief Financial Officer Dale Sander said.

Cost of goods sold rose to $1.4 million from $0.3 million a year earlier. Of the latest quarter’s total, $0.8 million was primarily overhead associated with unused production capacity. Sander said those costs would likely continue to flow through cost of goods sold in the fourth quarter, but the company has a more active production schedule planned for 2027.

Humacyte reported $64.9 million in cash, cash equivalents and restricted cash at September 30. Cash used in operating activities fell to $15 million for the quarter from $23.9 million a year earlier, which Sander attributed primarily to lower inventory production costs and earlier cost-reduction measures.

Niklason said the company continues benchtop work on its BioVascular Pancreas program but is concentrating resources on manufacturing and the commercial sales ramp. She said Humacyte may devote more resources to the program next year.

About Humacyte (NASDAQ:HUMA)

Humacyte, Inc is a biotechnology company developing bioengineered human tissues for use in regenerative medicine and vascular repair. The company's platform is designed to create implantable, off-the-shelf tissues that can be stored and used when needed without requiring the collection of tissue from the patient.

Its primary product is SYMVESS, an acellular tissue-engineered vessel intended to replace or repair damaged blood vessels. In December 2024, the U.S. Food and Drug Administration approved SYMVESS for use in the urgent treatment of extremity arterial injuries when emergency vascular reconstruction is required.

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