Full Press Release Details
Addition of Chief Commercial Officer and Integration of Commercial-Scale Manufacturing into Clinical Trial Programs
Durham, N.C. - Aug. 17, 2021 - Humacyte, Inc., a clinical-stage
biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced advancements
in its commercial operations with the appointment of B.J. Scheessele as Chief Commercial Officer. In addition, Human Acellular Vessels
(HAVs) produced in the Durham, N.C. facility are being administered to subjects throughout the U.S., Europe and Israel as part of clinical
trials that are being conducted under two investigational new drug applications. Humacyte expects to submit a biologics license application
(BLA) to FDA in 2022 seeking approval of the HAV for its initial indication in vascular trauma.
Mr. Scheessele will provide leadership, direction and strategic vision
to drive the commercial launch of the HAV in its initial vascular indications and follow-on market expansion. Prior to joining Humacyte,
Mr. Scheessele served as Executive Vice President of Global Marketing for Quest Medical Imaging Inc., a recent Olympus Corporation acquisition.
Previously, Mr. Scheessele spent 10 years at LifeCell Corporation, a leader in the Regenerative Medicine market, where he held roles of
increasing responsibility in sales and marketing, culminating in Vice President of North America Marketing and Canada Country Manager.
Earlier in his career, he worked in business development and product management with Cordis Corporation, a Johnson & Johnson Company.
Mr. Scheessele earned a BSE in biomedical engineering and economics and an MBA from Duke University.
"B.J. is a proven commercial leader and growth catalyst who brings
more than 20 years of unique experience in creating and growing commercial organizations for regenerative medicine products," said
Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. "B.J. has tremendous depth of experience in both human tissue
products, as well as cardiovascular devices, making him a perfect fit for Humacyte's growing pipeline. Humacyte is making huge strides
in our overall commercial readiness while concurrently working on clinical trials for our vascular programs. These recent developments
are cornerstones of a successful commercial infrastructure which will propel our company forward following FDA approval."
Humacyte's cutting-edge, large-scale, commercial manufacturing systems,
known as "Luna200 ", are housed in its 83,000-square-foot state-of-the-art bioprocessing facility in Durham, N.C. Each
modular, automated Luna200 system, with enhanced process controls, can grow 200 HAVs at a time. Humacyte previously presented data from
its Phase 2 comparability clinical trial evaluating HAVs manufactured in the Luna200 system at the International Conference on Tissue
Engineering and Regenerative Medicine. Clinical results demonstrated comparable three-month safety and efficacy outcomes to the prior,
pilot-scale systems previously used to manufacture the HAV.
The Durham facility is fully operational and capable of supplying current
clinical trial product needs in the U.S. The facility also achieved compliance with EU good manufacturing practices (GMP) and Qualified
Person Certification to allow product to be supplied to ongoing studies in Europe and Israel. The Durham facility has ample space to house
enough Luna systems to produce an annual capacity of approximately 40,000 HAVs per year, which Humacyte anticipates to be adequate to
meet future commercial supply demands.
"Our ability to leverage the Durham facility significantly increases
our capacity to produce HAVs for clinical trials and is an important milestone toward becoming a commercial company," said Mr. Scheessele.
"This is a tremendous achievement that reflects years of engineering, validation and qualification efforts. I am impressed by the
Humacyte team and their progress, and I look forward to the work ahead to lead our growth to a commercial-stage company."
Humacyte's HAVs were the first product to receive the FDA's
Regenerative Medicine Advanced Therapy (RMAT) expedited review designation. Humacyte's HAVs have not yet been approved for commercial
sale in the U.S. or elsewhere.
On February 17, 2021, Alpha Healthcare Acquisition Corp. (Nasdaq: AHAC)
("AHAC"), a special purpose acquisition company, and Humacyte announced the execution of a definitive business combination
agreement along with a fully committed $175 million PIPE financing agreement. On August 24, 2021, AHAC will hold a special shareholder's
meeting to vote on the proposed business combination with Humacyte.
Humacyte, Inc., is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues and organs
designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues
to treat a wide range of diseases, injuries and chronic conditions. Humacyte's initial opportunity, a portfolio of human acellular
vessels (HAVs), is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair,
arteriovenous access for hemodialysis, and peripheral arterial disease. Pre-clinical development is also underway in coronary artery bypass
grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte's HAVs
were the first product to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) expedited review designation and received
priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.
About Alpha Healthcare Acquisition Corp.
Alpha Healthcare Acquisition Corp. (ticker: AHAC) is a special purpose acquisition company formed for the purpose of effecting a business
combination with one or more businesses in the healthcare sector ("AHAC"). The company was founded by Mr. Rajiv Shukla who
has two decades of buyouts, investments and operations experience in the healthcare industry. Mr. Shukla previously served as Chairman
and Chief Executive Officer of Constellation Alpha Capital Corp., a Nasdaq-listed special purpose acquisition company, that merged
with DermTech, Inc (ticker: DMTK) in August 2019. On February 17, 2021, AHAC announced a definitive agreement to merge with Humacyte,
Inc. along with a concurrent fully committed PIPE placement of $175 million of AHAC common shares at a price of $10.00 per share.
Important Information About the Merger and Special
AHAC Special Shareholder Meeting
The Special Meeting will be held virtually via webcast at 10:00 a.m. EDT on August 24, 2021, and can be accessed by visiting: https://www.cstproxy.com/alphahealthcareacquisition/sm2021.
Shareholders can attend the Special Meeting using the meeting instructions outlined in AHAC's definitive proxy statement. Shareholders
of record as of the close of business on July 21, 2021, will be entitled to vote their shares at the Special Meeting. AHAC has engaged
Morrow Sodali LLC as its proxy solicitor in connection with the Special Meeting and shareholders requiring assistance in voting can contact
their broker or Morrow Sodali LLC for assistance, at (800) 662-5200. The AHAC Board of Directors unanimously recommends that shareholders
vote "FOR" the Business Combination with Humacyte as well as the other proposals set forth in the proxy statement.
The proxy statement and AHAC's
other reports filed with the Securities and Exchange Commission ("SEC") can be obtained, without charge, by directing a request
to: info@alphaspac.com. The definitive proxy statement/prospectus included in AHAC's registration statement on Form S-4 can also
be obtained, without charge, at the SEC's website (www.sec.gov).
A full description of the terms
of the business combination is provided in the definitive proxy statement/prospectus included in AHAC's registration statement on
Form S-4 filed with the SEC. AHAC urges its investors, shareholders, and other interested persons to read the proxy statement/ prospectus
as well as other documents filed with the SEC because these documents will contain important information about AHAC, Humacyte and the
business combination.
Participants in the Solicitation
AHAC and Humacyte and their respective directors and executive officers may be considered participants in the solicitation of proxies
with respect to the proposed business combination described in this press release under the rules of the SEC. Information about the directors
and executive officers of AHAC is set forth in AHAC's final prospectus filed with the SEC pursuant to Rule 424(b) of the Securities
Act of 1933, as amended (the "Securities Act") on September 17, 2020, and is available free of charge at the SEC's website
at www.sec.gov or by directing a request to: Alpha Healthcare Acquisition Corp., Attn: Secretary, 1177 Avenue of the Americas, 5th Floor,
New York, New York 10036. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the
solicitation of the AHAC shareholders in connection with the proposed business combination is set forth in the registration statement
containing the proxy statement/prospectus for the proposed business combination. These documents can be obtained free of charge from the
sources indicated above.
Forward-Looking Statements
This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available.
In some cases, you can identify forward-looking statements by the following words: "may," "will," "could,"
"would," "should," "expect," "intend," "plan," "anticipate," "believe,"
"estimate," "predict," "project," "potential," "continue," "ongoing"
or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These
statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements
to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we
have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based
on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking
statements in this press release include, but are not limited to, statements regarding the initiation, timing, progress, and
results of our clinical trials; the anticipated characteristics and performance of our HAVs, our ability to successfully complete, pre-clinical
and clinical trials for our HAVs; the anticipated benefits of our HAVs relative to existing alternatives; the commercialization of our
HAVs and our ability to manufacture at commercial scale; the implementation of our business model, strategic plans for our business; our
rights and obligations under our partnership with Fresenius Medical Care; the scope of protection we are able to establish and maintain
for intellectual property rights covering our HAVs and related technology; the timing or likelihood of regulatory filings and approvals;