Flourishing success: Hucyte’s rise from humble beginnings to a valuation of $ 1.1 billion
RESEARCH TRIANGLE PARK – Based in Durham Humacyte, a regenerative medicine company that received start-up support from the North Carolina Biotechnology Center 15 years ago, goes public in a new deal that will give it a market capitalization of $ 1.1 billion.
Humacyte and Alpha Healthcare Acquisition Corp., a New York-based Special Purpose Acquisition Company (SPAC), signed a Business Combination Agreement to IPO Humacyte, as well as a $ 175 Million PIPE Funding Agreement of dollars.
“We are very pleased to have the support of leading investors and to have access to the US capital markets following the closing of this proposed transaction, which will leave Humacyte well capitalized to provide top notch therapies. to treat several life-threatening illnesses. “said Laura Niklason, MD, Ph.D., founder and CEO of Humacyte, in a prepared statement.
Niklason will lead the combined company, which will be listed on the Nasdaq Capital Market under the ticker symbol “HUMA”. The transaction has been approved by the board of directors of both companies and is expected to close in the second quarter, subject to shareholder approval.
The deal will give Humacyte a valuation of approximately $ 800 million and up to $ 255 million in cash proceeds, including fully committed PIPE funding of $ 175 million, priced at $ 10 per share, and up to $ 100 million in cash held in trust.
The PIPE offer was raised from a large group of healthcare investors including Fresenius Medical Care, OrbiMed, Monashee Investment Management, Alexandria Venture Investments, UBS O’Connor, Morgan Creek Capital and a number anonymous funds focused on health care. Most of the company’s existing investors have participated in PIPE.
PIPE, or private investment in public stocks, is the practice of private investors who buy publicly traded stocks at a preferential price. PIPE offers are often offered by companies looking to raise a large amount of capital quickly.
Key partnership with Fresenius
Humacyte was founded in 2004 and the Biotechnology Center granted it a $ 150,000 Small Business Research Loan in 2006.
Since then, Humacyte has raised nearly $ 480 million, including a $ 150 million equity investment from Fresenius Medical Care, the world’s leading provider of products and services for kidney disease patients and surgical care centers. .
“Humacyte is a world-class regenerative medicine company that develops bioengineered tissues to address unmet medical needs,” said Vivian Doelling, Ph.D., vice president of Emerging Companies Development at NCBiotech . “The company has been a pioneer in these advanced and readily available technologies. This is one of the best examples of North Carolina-based ingenuity and medical advancement. “
Humacyte’s platform technology allows it to create ready-to-use replacement tissues that can be implanted in anyone.
“Humacyte’s innovative biotech platform aims to solve intractable medical problems,” said Rajiv Shukla, president and CEO of Alpha Healthcare Acquisition Corp. The technology has the potential to help patients, doctors and insurers, he said.
Patients can benefit from a reduced risk of amputation and tissue rejection, elimination of wait times, and a reduced need for immunosuppression and additional surgeries. Doctors can achieve better clinical results and ease of use. And payers can cut costs by avoiding amputations and infections, additional surgeries, medications, and readmissions.
Humacyte’s most advanced product candidate, human acellular vessels (HAV), is in advanced clinical trials targeting vascular trauma repair, arteriovenous access for hemodialysis and peripheral arterial disease.
To date, more than 430 patients have been treated with HAV in clinical trials, and the company has collected more than 800 patient years of clinical data. So far, there has been no immunological rejection of HAVs.
Humacyte is on track to have its first commercial product within two years, a timeline aided by the US Food and Drug Administration’s Fast Track and Regenerative Medicine Advanced Therapy designations.
Humacyte has a commercial partnership with Fresenius for the use of its HAVs in dialysis and peripheral artery disease, as well as vascular trauma in markets outside of the United States.
Longer-term, Humacyte’s technology could create solutions for complex organ diseases, including bioengineered tissue and replacement organs for coronary artery bypass grafts, pediatric heart surgery, and the treatment of diabetes. type 1.
Markets for the company’s potential products are estimated at $ 150 billion. If its products are approved, Humacyte projects maximum annual sales of over $ 12 billion.
Technology developed at Duke, MIT
Humacyte’s technology is based on research by Niklason, a leader in tissue engineering, and scientists Shannon Dahl and Juliana Blum, at Duke University, and on Niklason’s previous research at the Massachusetts Institute of Technology in the laboratory of Robert Langer.
Proprietary technology is protected by 87 issued patents and 21 pending patents.
The technology does not rely on the direct transplantation of human cells or tissues as therapies or products. Instead, it uses banked human vascular cells as seeds to create matrix-based extracellular tissues that can be made into tubes, sheets, or other shapes with properties similar to native tissues. The vascular cells are then removed to avoid triggering an immune response or infection in patients receiving the modified tissue.
“Our innovative platform has the potential to support tissue repair, reconstruction and replacement without the limitations of existing standards of care,” said Niklason. “Humacyte’s bioengineered tissues can be produced on a commercial scale and, after regulatory approval, are designed to be stored in hospitals and other surgical centers, and immediately available to surgeons when needed. “
The company’s workforce has grown to 130 employees, including scientists, clinical, manufacturing, regulatory and commercial experts. They work at a state-of-the-art research and development and bioproduction facility in Durham which was built in 2018.
The facility can be expanded to produce up to 40,000 HAVs per year.