Fed Governor Adriana Kugler to resign
DURHAM, N.C. - Humacyte, Inc. (NASDAQ:HUMA) saw its shares plunge 10.4% after reporting a narrower fourth-quarter loss but no revenue, as investors appeared concerned about the biotech company’s path to profitability despite recent FDA approval of its vascular graft product.
The commercial-stage biotechnology company reported a fourth-quarter loss of $0.16 per share, beating analyst estimates for a $0.25 per share loss. However, Humacyte generated no revenue in the quarter, matching the year-ago period when it also had zero sales.
Humacyte’s lack of revenue comes despite receiving FDA approval in December for Symvess, its bioengineered blood vessel product for treating extremity vascular trauma. The company began its commercial launch in late February, shipping its first units to two Level 1 trauma centers last week.
"Our commercial launch of Symvess is proceeding at full speed and we are excited by the response to date from hospitals and healthcare providers," said CEO Laura Niklason. She noted that 34 hospitals have already initiated the approval process to purchase Symvess, with three hospitals having completed approvals.
For the full year 2024, Humacyte reported a net loss of $148.7 million, wider than the $110.8 million loss in 2023. The increased loss was attributed primarily to higher research and development expenses as well as preparation costs for Symvess’ commercial launch.
The company ended 2024 with $95.3 million in cash and equivalents. It subsequently raised approximately $46.6 million through a public stock offering in March 2025.
Humacyte is planning to file an IND application in 2025 to begin human trials of a small-diameter engineered vessel for coronary artery bypass grafting. It also aims to submit a supplemental application in late 2026 to expand Symvess’ approved uses to include dialysis access.
BTIG analyst Ryan Zimmerman maintained a Buy rating on the stock, but lowered its price target from $10.00 to $8.00, saying, " All told, we view HUMA’s early commercial traction as evidence of the game-changing nature of the ATEV and look for future milestones as further proofpoints."
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.