DURHAM, N.C. - Humacyte, Inc. (NASDAQ:HUMA), a biotechnology firm specializing in bioengineered human tissues, has been informed by the U.S. Food and Drug Administration (FDA) that it will need more time to review the company's Biologic License Application (BLA) for its acellular tissue engineered vessel (ATEV) designed for vascular trauma. Humacyte's CEO, Laura Niklason, M.D., Ph.D., confirmed the delay following a communication from the FDA's Center for Biologics Evaluation and Research (CBER).
The ATEV, considered a first-in-class product, was submitted for FDA approval in December 2023 and was subsequently granted Priority Review in February 2024, which shortened the review cycle from the standard ten months to six months, with an original Prescription Drug User Fee Act (PDUFA) action date set for August 10, 2024. Despite the expedited review process, the FDA has not provided a new expected completion date for their review.
ATEV has been developed as a universally implantable vascular conduit for arterial replacement and repair, offering an off-the-shelf solution for vascular trauma, which avoids the need for vein harvesting from the patient. The BLA submission included positive results from the V005 pivotal Phase 2/3 clinical study, as well as real-world evidence from the treatment of wartime injuries in Ukraine.
The product has been used in Level 1 Trauma centers in the U.S. and Israel and in front-line hospitals in Ukraine. Clinical observations have shown high rates of patency, or blood flow, with low rates of amputation and infection. Humacyte expressed confidence in the approvability of ATEV based on the FDA's feedback and interactions during the review process.
The company will discuss the status of the ATEV review during its 2nd quarter 2024 financial report and business update conference call scheduled for August 13, 2024. The call will provide an opportunity for management to address investor inquiries.
Humacyte's technology platform aims to deliver bioengineered tissues and organ systems to improve patient care and outcomes. The ATEV for vascular trauma indication is one of several products the company is developing, with preclinical work on applications such as coronary artery bypass grafts and treatment of type 1 diabetes also underway.
In other recent news, biotechnology firm Humacyte, Inc. has made significant strides in its operations. The company reported a net loss of $31.9 million for the first quarter of 2024, however, it secured $63 million in funding, ending the quarter with $115.5 million in cash and cash equivalents. TD Cowen maintained a buy rating on Humacyte, setting a target price of $7.50, reflecting the firm's confidence in the company's potential.
Humacyte also announced the addition of two new members to its Board of Directors, Dr. John P. Bamforth and Dr. Keith Anthony Jones. The company's Biologics License Application for the Humacyte Vascular Access Graft has been accepted by the FDA, granting it Priority Review. In addition, Humacyte has received approval for four new ICD-10-PCS codes from the U.S. Centers for Medicare & Medicaid Services, a significant step towards a New Technology Add-on Payment application expected later in 2024.
InvestingPro Insights
As Humacyte, Inc. (NASDAQ:HUMA) navigates the regulatory process with the FDA for its innovative ATEV product, investors are closely monitoring the company's financial health and market performance. According to InvestingPro data, Humacyte holds a market capitalization of approximately $943.74 million, reflecting the biotech firm's potential in a competitive industry. Despite challenges in profitability, with a P/E ratio currently at -7.91 and an adjusted P/E ratio for the last twelve months as of Q1 2024 at -9.11, the company's stock has experienced a significant price uptick, boasting a 120.39% return over the last six months and a 159.74% return over the last year.
An InvestingPro Tip highlights that Humacyte has more cash than debt on its balance sheet, which could be a sign of financial stability and may provide some cushion as it awaits FDA decisions. However, the company is noted for weak gross profit margins, with a gross profit of -$80.54 million, which may raise concerns about its long-term profitability. As the company anticipates discussing the ATEV review during its upcoming financial report, investors may find value in the fact that Humacyte's liquid assets exceed its short-term obligations, suggesting a strong liquidity position.
For those interested in a deeper dive into Humacyte's financials and market performance, there are additional InvestingPro Tips available on the platform, including analysis on the company's volatile stock price movements and insights into its trading multiples. With a high Price / Book multiple of 35.97 as of the last twelve months, the company's valuation reflects investor optimism for its growth prospects despite not being profitable over the past year and analysts not anticipating profitability for this year either.
To explore further detailed insights and tips, visit InvestingPro at: https://www.investing.com/pro/HUMA, where you can find a comprehensive list of 11 additional InvestingPro Tips for Humacyte, Inc.
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