Humacyte, Inc., a clinical-stage biotechnology platform company
developing universally implantable bioengineered human tissue at
commercial scale, today announced the successful completion of its
business combination (the “Business Combination”) with Alpha
Healthcare Acquisition Corp. (Nasdaq: AHAC) (“AHAC”), a special
purpose acquisition company sponsored by Constellation Alpha
Holdings. The resulting combined company, Humacyte, is expected to
commence trading of its shares of common stock and warrants on the
Nasdaq Global Select Market® under the ticker symbols "HUMA" and
“HUMAW,” respectively, on August 27, 2021. The Business
Combination was approved by AHAC stockholders on August 24, 2021.
Humacyte’s Human Acellular Vessels (HAVs) are engineered,
off-the-shelf replacement vessels initially being developed for
vascular repair, reconstruction and replacement. HAV is intended to
overcome long-standing limitations in vascular repair and
replacement – it can be manufactured at commercial scale, it has
the potential to eliminate the need for harvesting a vessel from a
patient, and clinical evidence suggests that it is non-immunogenic,
infection-resistant, and can become durable living tissue. HAV is
currently being evaluated in two Phase 3 trials in AV access and a
Phase 2/3 trial for vascular trauma, and has been implanted in more
than 430 patients. It is the first product to receive Regenerative
Medicine Advanced Therapy (RMAT) designation from the U.S. Food and
Drug Administration, and has also received FDA Fast Track
designation.
“Humacyte is poised to make commercial-scale bioengineered
tissues a reality for patients,” said Laura Niklason, M.D., Ph.D.,
Founder, President and Chief Executive Officer. “We enter the next
phase of our transformation of regenerative medicine as a robust
public company, evaluating our first-in-class bioengineered HAVs in
numerous indications. We set out with the lofty goal of changing
the practice of medicine, and we are closer than ever today thanks
to the unwavering commitment of our employees, our partners and our
investors. I am confident that we have the right team, including
the appointment of Kathleen Sebelius as Chair of our Board, to
deliver on the promise of our breakthrough science.”
Humacyte will continue to be led by Dr. Niklason and its current
executive team. Dr. Niklason is one of only a handful of women in
history to found a biotechnology company that she also took public
as the CEO, at a valuation exceeding $1 billion. Ms. Sebelius, CEO
of Sebelius Resources and former Secretary of the Department of
Health and Human Services, has been appointed Chair of the
Company’s Board of Directors. All previously announced
post-Business Combination Board nominees have also been elected to
serve as directors of Humacyte.
“Humacyte’s innovative biotechnology platform is aimed at
solving intractable medical problems for (1) Patients: potential
for lower risk of amputation and tissue rejection, elimination of
waiting times, and reduced need for immunosuppression and
additional surgeries; (2) Physicians: potential for better clinical
outcomes and ease of use; and (3) Payors: potential cost savings by
avoiding amputations and infections, additional surgeries,
medication and re-hospitalizations,” said Rajiv Shukla, Chairman
& CEO of AHAC. “I am excited to work with the Humacyte Board
and Team to fulfill this vision.”
“Humacyte is a pioneer both in the field of regenerative
medicine and as a woman-founded biotech company, where an
innovative culture and world-class science have come together to
make a meaningful difference for patients and the practice of
medicine,” said Ms. Sebelius. “With a validated HAV platform
technology and vast potential application, compelling data, a
well-defined regulatory pathway, and scalable, proprietary
commercial-scale manufacturing capability, Humacyte has all the
ingredients to revolutionize patient care. It’s been an honor to
serve on Humacyte’s Board for the past six years, and I now look
forward to leading the Board and collaborating with the Humacyte
leadership team in the important work ahead.”
Transaction DetailsAs a result of the Business
Combination, the Company has received gross proceeds of
approximately $245 million, including a $175 million PIPE financing
and $70 million of cash held in the former AHAC trust account.
Participating PIPE investors included Fresenius Medical Care,
OrbiMed, Monashee Investment Management, Alexandria Venture
Investments, UBS O’Connor, Morgan Creek Capital, and a number of
other health care focused funds.
Piper Sandler & Co. acted as lead placement agent and
financial advisor to AHAC. Exos acted as co-placement agent and
financial advisor to AHAC. Oppenheimer and Lake Street Capital
Markets acted as financial advisors to AHAC. Cowen acted as capital
markets advisor to Humacyte. Goodwin Procter LLP acted as legal
counsel to AHAC. DLA Piper acted as legal counsel to the placement
agents. Covington & Burling LLP acted as legal counsel to
Humacyte in the transaction.
Nasdaq Closing Bell EventIn celebration of the
closing of the Business Combination and its debut on Nasdaq Global
Select Market, Humacyte will ring the Nasdaq Stock Market Closing
Bell on Monday, August 30, 2021, at 4 p.m. EDT, at the Nasdaq
MarketSite in New York City. Dr. Niklason will be joined by company
executives and Board members and their families for the ceremony. A
live webcast of the ceremony will begin at 3:45 p.m. EDT and be
available at https://livestream.com/nasdaq/live.
About HumacyteHumacyte, 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.
Forward-Looking StatementsThis 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; timing,
scope, and rate of reimbursement for our HAVs; and our estimated
available market opportunity.We cannot assure you that the
forward-looking statements in this press release will prove to be
accurate. These forward-looking statements are subject to a number
of significant risks and uncertainties that could cause actual
results to differ materially from expected results, including,
among others, the impact of COVID-19 on Humacyte’s business,
changes in applicable laws or regulations, the possibility that
Humacyte may be adversely affected by other economic, business,
and/or competitive factors, and other risks and uncertainties,
including those included under the header “Risk Factors” in the
registration statement on Form S-4 filed by Humacyte with the SEC.
Most of these factors are outside of Humacyte’s control and are
difficult to predict. Furthermore, if the forward-looking
statements prove to be inaccurate, the inaccuracy may be material.
In light of the significant uncertainties in these forward-looking
statements, you should not regard these statements as a
representation or warranty by us or any other person that we will
achieve our objectives and plans in any specified time frame, or at
all. The forward-looking statements in this press release represent
our views as of the date of this press release. We anticipate that
subsequent events and developments will cause our views to change.
However, while we may elect to update these forward-looking
statements at some point in the future, we have no current
intention of doing so except to the extent required by applicable
law. You should, therefore, not rely on these forward-looking
statements as representing our views as of any date subsequent to
the date of this press release.
Humacyte Investor
Contact:investors@humacyte.com
Humacyte Media Contact: media@humacyte.com
Photos accompanying this announcement are available
at:
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