SEATTLE - Pluristyx, a biotechnology company specializing in cellular therapy development, has entered into a licensing agreement with Humacyte, Inc., a clinical-stage biotech firm.
Under the agreement, Humacyte will utilize Pluristyx's clinical-grade induced Pluripotent Stem Cell (iPSC) line, part of the PluriBank™ collection, for the production of insulin-producing cells. These cells are intended for use in Humacyte's BioVascular Pancreas (BVP™) product candidate, which is being developed to treat insulin-dependent diabetes.
The partnership also grants Humacyte access to Pluristyx's panCELLa™ platform, which is designed to create "hypoimmune" cells for clinical implantation, potentially improving the safety and efficacy of cellular therapies. Pluristyx's iPSC lines are derived from regulatory-compliant donors and are extensively characterized to ensure purity, identity, and genetic integrity, prioritizing patient safety.
Dr. Benjamin Fryer, CEO of Pluristyx, expressed optimism about the collaboration's potential to advance the treatment of insulin-dependent diabetes. The company is also performing custom clinical gene editing on the iPSC line to generate a universally applicable line suitable for all patients.
Humacyte's BVP aims to revolutionize type 1 diabetes treatment by enabling the delivery and survival of insulin-producing islets within the body. However, both the BVP and the Acellular Tissue Engineered Vessel (ATEV™) are still investigational products and have yet to receive approval from the Food and Drug Administration (FDA) or any international regulatory agency.
Humacyte, listed on Nasdaq as HUMA, is known for its biotechnology platform that develops universally implantable bioengineered human tissues and organs. Its portfolio of Acellular Tissue Engineered Vessels is currently in late-stage clinical trials for various vascular applications.
The information for this article is based on a press release statement.
In other recent news, Humacyte Inc. has seen significant developments, beginning with TD Cowen reiterating a Buy rating and increasing the price target for the company's shares to $7.50. This follows the release of promising preclinical data on Humacyte's BioVascular Pancreas product, which successfully restored normal blood glucose levels in non-human primate models.
The U.S. Centers for Medicare & Medicaid Services has approved four new ICD-10-PCS codes for procedures involving Humacyte's Human Acellular Vessels, a key step towards a New Technology Add-on Payment application in 2024.
Financially, Humacyte reported a net loss of $31.9 million for Q1 2024 but secured $63 million in funding, ending the quarter with $115.5 million in cash and cash equivalents. The company has also announced a reshuffle of its board of directors and the ratification of PricewaterhouseCoopers LLP as its independent auditor.
Humacyte's Biologics License Application for the Humacyte Vascular Access Graft has been accepted by the FDA, granting it Priority Review. All these recent developments underscore the company's ongoing efforts to commercialize its flagship product.
InvestingPro Insights
As Humacyte, Inc. (HUMA) forges ahead with its innovative cellular therapy developments, investors and industry watchers are keeping a close eye on the company's financial health and stock performance. With a market capitalization of $680.57 million, Humacyte presents a unique profile in the biotech space.
InvestingPro data reflects a challenging financial landscape for the company, with a negative P/E ratio (last twelve months as of Q1 2024) of -6.53, indicating that the company is not currently profitable. Moreover, the company's gross profit for the same period stands at a negative $80.54 million, and its operating income is also in the red at -$101.01 million, underscoring the costs associated with its research and development activities.
Despite these financial metrics, the company's stock price has shown significant resilience and growth potential. InvestingPro Tips highlight that Humacyte holds more cash than debt, which is a positive sign of financial stability.
The company's stock has experienced a high return over the last year, with a year-to-date price total return of 99.65% and a substantial 86.51% return over the last three months. This suggests investor confidence in the company's long-term prospects and the potential of its BioVascular Pancreas product candidate.
For those interested in deeper analysis, InvestingPro offers more tips on Humacyte, including insights on stock price volatility and analyst profitability expectations. With the provided coupon code PRONEWS24, readers can get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription to access these valuable insights. There are an additional 12 InvestingPro Tips available for Humacyte, which could further guide investment decisions.
As Humacyte continues to navigate the complex landscape of clinical-stage biotechnology, these financial metrics and stock performance indicators will be crucial for investors to monitor. The partnership with Pluristyx has the potential to not only enhance the company's product offerings but also influence its financial trajectory in the dynamic biotech market.
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