Humacyte and Pluristyx enhance partnership for diabetes treatment

DURHAM, N.C. - Humacyte, Inc. (NASDAQ:HUMA), a biotechnology firm specializing in bioengineered human tissues with a current market capitalization of $580 million, and Pluristyx, Inc., a provider of cellular therapy development tools, have announced the expansion of their collaborative efforts. According to InvestingPro data, while the company operates with moderate debt levels, it faces challenges with cash burn and profitability. The partnership focuses on developing Humacyte’s investigational BioVascular Pancreas (BVP™), a potential treatment for insulin-dependent diabetes.

Pluristyx is contributing its expertise in gene editing of PluriBank™ iPSC lines, which are utilized by Humacyte in the creation of their BVP. This system is intended to house and protect insulin-producing islets with the goal of stabilizing glucose levels in diabetic patients. Pluristyx has refined a clinical-grade manufacturing process for gene editing, using licensed Mad7 technology to suppress the expression of Human Leukocyte Antigen (HLA) markers, which can help the islets evade the immune system.

This collaboration builds upon Humacyte's existing license for Pluristyx’s PluriBank cell lines. Laura Niklason, M.D., Ph.D., CEO of Humacyte, expressed enthusiasm about the partnership's potential to advance the development of the BVP and other cell and tissue therapies.

Recently, Humacyte achieved a significant milestone with the FDA approval of its Symvess™ (acellular tissue engineered vessel) for use in vascular trauma. This breakthrough has contributed to the stock's impressive 55% return over the past year, despite showing recent weakness with a 43% decline over the last six months, according to InvestingPro data. Benjamin Fryer, Ph.D., CEO of Pluristyx, highlighted this achievement and voiced support for Humacyte's ongoing work on the BVP.

The BVP is currently in pre-clinical development and has not yet been approved for sale by the FDA or any other regulatory body.

Humacyte is known for its innovative approach to creating universally implantable bioengineered human tissues and organ systems. The company has previously received FDA approval for its acellular tissue engineered vessel (ATEV) for vascular trauma and is conducting late-stage clinical trials for other vascular applications.

The information in this article is based on a press release statement from Humacyte, Inc. Based on InvestingPro analysis, the company currently appears slightly undervalued, with analysts setting price targets ranging from $6 to $25 per share. Discover more detailed insights and 8 additional ProTips about HUMA's financial health and growth prospects with an InvestingPro subscription, including access to comprehensive Pro Research Reports covering 1,400+ US stocks.

In other recent news, Humacyte, a biotechnology company, has made significant strides with its bioengineered human tissue products. The company has received full FDA approval for its SYMVESS product, a major advancement in regenerative medicine. The product, designed for use in adults requiring urgent revascularization to prevent imminent limb loss, has shown superiority over synthetic grafts in a study published in JAMA Surgery.

Humacyte is also preparing to file an Investigational New Drug application for a small-diameter acellular tissue-engineered vessel (sdATEV) intended for coronary artery bypass grafting. This decision is based on encouraging preclinical results and an agreement with the FDA. Additionally, Humacyte has reported a decrease in net loss to $39.2 million in Q3 2024, despite not generating any revenue.

Analysts have responded positively to these developments. Benchmark raised the price target for Humacyte to $17.00, while maintaining a Buy rating. H.C. Wainwright also raised its price target to $15.00 and BTIG reaffirmed its Buy rating with a $10.00 price target. These are recent developments reflecting the company's progress and potential.

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