DURHAM, N.C. - Humacyte, Inc. (NASDAQ:HUMA), a biotechnology company focused on bioengineered human tissues, announced today the addition of two new members to its Board of Directors as it gears up for the anticipated commercial launch of its Acellular Tissue Engineered Vessel (ATEV) for vascular trauma.
Dr. John P. Bamforth, a pharmaceutical industry veteran, and Dr. Keith Anthony (Tony) Jones, a distinguished health system and academic physician, will be joining the company's board.
Dr. Bamforth brings extensive experience in commercialization, having held various roles at Eli Lilly and Company (NYSE:LLY) over three decades, including Chief Marketing Officer for both the U.S. and global businesses.
He also co-founded the Ciara Arts and Sciences Foundation. Dr. Jones has significant medical and administrative expertise from his leadership roles at the University of Alabama-Birmingham Health System.
Humacyte's ATEV, which is still under FDA review with a Prescription Drug User Fee Act (PDUFA) date set for August 10, 2024, is designed to be used in vascular trauma repair among other applications. The product has not yet been approved for sale but has received Priority Review status from the FDA.
The company is developing its ATEVs to treat a variety of diseases, injuries, and chronic conditions, with its 6mm ATEV for arteriovenous (AV) access in hemodialysis being the first to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation. Additional RMAT designations have been granted for the ATEV in urgent arterial repair following extremity vascular trauma and for peripheral artery disease.
The announcement of the new board members comes as Humacyte prepares for its transition to commercial operations. The company's product candidates are in late-stage clinical trials targeting multiple vascular applications. The information presented in this article is based on a press release statement from Humacyte, Inc.
In other recent news, biotechnology company Humacyte has seen a series of significant developments. TD Cowen has maintained a buy rating on Humacyte, setting a target price of $7.50, reflecting the firm's confidence in the company's potential following successful preclinical data on Humacyte's BioVascular Pancreas product.
Humacyte also reported financial results for the first quarter of 2024, disclosing a net loss of $31.9 million, but successfully secured $63 million in funding, ending the quarter with $115.5 million in cash and cash equivalents. These financial details are crucial for investors in understanding the company's current fiscal position.
Additionally, 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.
In terms of corporate governance, Humacyte announced a reshuffle of its board of directors and the ratification of PricewaterhouseCoopers LLP as its independent auditor.
InvestingPro Insights
As Humacyte, Inc. (NASDAQ:HUMA) positions itself for the commercial launch of its innovative Acellular Tissue Engineered Vessel (ATEV), the financial health and market performance of the company provide key insights for investors. With a market capitalization of around $1 billion, Humacyte stands as a significant player in the biotech industry.
An InvestingPro Tip that stands out for Humacyte is its strong return over the last year, with a one-year price total return of 177.23%. This impressive performance is further underscored by the company's significant price movements in shorter time frames, including a 43.47% return over the last week and a notable 195.77% year-to-date price total return. Such metrics indicate a robust investor enthusiasm for the stock, which may be tied to the anticipated FDA review of its ATEV product.
In terms of financial ratios, Humacyte's Price / Book ratio as of the last twelve months stands at a high 38.25, which may suggest a premium valuation by the market in expectation of future growth. However, the company's P/E ratio remains negative at -8.51, reflecting the current lack of profitability, a common trait among growth-focused biotech firms.
Investors considering Humacyte should be aware of the company's volatile stock price movements, as highlighted by an InvestingPro Tip. Additionally, while the company holds more cash than debt on its balance sheet, it is important to note that analysts do not anticipate the company will be profitable this year. For those interested in a deeper dive into Humacyte's financials and future prospects, InvestingPro offers additional tips and metrics on their platform, with a total of 13 InvestingPro Tips available for HUMA at https://www.investing.com/pro/HUMA.
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