Alpha Healthcare Acquisition Corp. (Nasdaq: AHAC) (“AHAC”), a
special purpose acquisition company led by Mr. Rajiv Shukla, today
announced execution of definitive business combination agreement
along with a fully committed PIPE financing agreement with
Humacyte, Inc. (“Humacyte”), a clinical-stage biotechnology
platform company developing universally implantable bioengineered
human tissue at commercial scale. Upon closing of the transaction,
AHAC will be renamed Humacyte, Inc. (the “Combined Company”) and
will be led by Laura Niklason, M.D., Ph.D., Chief Executive Officer
of Humacyte. The Combined Company’s common stock is expected to be
listed on the Nasdaq Capital Market under the ticker symbol “HUMA.”
A group of leading investors has committed to
participate in a common stock PIPE of approximately $175 million at
$10.00 per share that will close simultaneously with the business
combination. The Combined Company will also receive up to $100
million held in AHAC’s trust account at closing of the transaction,
subject to any redemptions by existing AHAC shareholders.
Additionally, existing Humacyte investors will be subject to a
12-month lockup with 50% eligible for sale after 6 months if the
20-day VWAP over any 30-day period equals or exceeds $15.00.
Humacyte Highlights
1. Clinical-stage biotechnology platform company
with multiple potential products
- Universally implantable: no need
for donor tissue matching or a lifetime of immunosuppression.
- Off-the-shelf: eliminate waiting
time for donor tissue or the need to harvest tissue through
surgical excision of the patient often dealing with existing
morbidity.
- Highly resistant to infection:
based on evidence from clinical trials to date.
- Regenerative and self-healing:
expected to transform into the patient’s own tissue by repopulating
with the patient’s own cells and undergoing angiogenesis.
2. Potential life-saving innovations
- It is estimated that 3.5 million
patients worldwide require hemodialysis every year. Each patient
needs safe and repeatable arteriovenous (AV) access for dialysis.
Humacyte’s Human Acellular Vessel (HAV), if approved, will provide
a potential alternative to synthetic grafts and AV fistulas.
- Over a million patients suffer from
type 1 diabetes in the U.S. alone. Humacyte’s BioVascular pancreas,
if approved, could be implanted in an outpatient procedure,
potentially eliminating the need for continuous glucose monitoring
and exogenous insulin therapy.
- Half a million coronary access
bypass grafts (CABG) are placed every year in the U.S. alone, most
requiring the harvesting of a vein from the patient’s leg for the
bypass conduit. Humacyte’s HAVs may potentially provide
long-lasting revascularization with an off-the-shelf vessel,
potentially eliminating the need for a second surgery to harvest a
vein from the patient.
- Vascular trauma affects tens of
thousands of patients per year in the U.S., and can lead to
amputation, infection and loss of life. Humacyte’s HAV is designed
to potentially restore blood flow to injured limbs without waiting
for vein tissue harvest.
- Peripheral arterial disease is a
growing health care problem, with over 100,000 procedures per year
in the U.S. to treat the disease. Humacyte’s HAV may provide an
alternative to vein stripping or artificial plastic implants for
treatment of this disease which, if left untreated, can lead to
infection, amputation and death.
3. Significant body of clinical evidence
- 5 Phase II clinical trials
completed: in hemodialysis access and peripheral arterial
disease.
- 3 Phase III clinical trials
ongoing: vascular trauma and AV access trials expected to be
complete by 2023.
- 430+ patients treated with HAVs to
date in clinical trials, no immunological rejections to date.
- 800+ patient-years of clinical data
with the HAVs implanted to date.
4. Extensive intellectual property rights
- 87 patents granted and 21 patents
pending.
- Proprietary human cell bank and
biomanufacturing processes.
- Considerable manufacturing know-how
and trade secrets.
- Over 300 publications by Humacyte
Executive Team on regenerative and vascular medicine.
5. $150+ billion in estimated total size of
markets targeted by Humacyte’s products, if approved
- Nearly $90 billion in market size
for potential vascular products.
- Over $65 billion in market size for
potential non-vascular products.
6. $12+ billion in potential annual peak sales
from Humacyte’s products, if approved
- Multibillion-dollar peak sales
potential from hemodialysis AV access, vascular trauma, peripheral
arterial disease, diabetes and CABG products.
- Substantial additional
opportunities under development include bioengineered lung,
trachea, urinary conduit and esophagus.
7. Well-defined regulatory pathway
- Fast Track designation granted by
the U.S. FDA in 2014.
- First company to receive
Regenerative Medicine Advanced Therapy (RMAT) designation, granted
by the U.S. FDA in 2017.
8. In-house commercial-scale manufacturing with
room for modular expansion
- Proprietary biomanufacturing
process that can operate at commercial scale.
- Extensive automation and process
monitoring and controls, designed for GMP compliance.
- Current facility with scale-out
expansion capability up to 40,000+ HAVs per year.
9. Nearly $480 million in financing raised to
date, including $150M equity investment from Fresenius Medical
Care
- Commercial partnership with
Fresenius Medical Care for the use of Humacyte’s HAV in dialysis AV
access and peripheral arterial disease, a collaboration that
includes vascular trauma in markets outside the U.S.
- Fresenius Medical Care is the
world's leading provider of products and services for individuals
with renal diseases and in surgical care centers.
“Humacyte is a global leader in developing
bioengineered tissues for use in regenerative medicine,” said Dr.
Niklason. “We are very pleased to have support from top-tier
investors, and access to the U.S. capital markets following the
closing of this proposed transaction, which will leave Humacyte
well-capitalized to provide first-in-class therapies to treat
several life-threatening diseases. Our innovative platform has the
potential to support tissue repair, reconstruction and replacement
without the limitations of existing standards of care. Humacyte’s
bioengineered tissues can be produced at commercial scale and,
after regulatory approval, are designed to be stored in hospitals
and other surgical centers, and immediately available to surgeons
whenever needed.”
Said Rajiv Shukla, Chairman & CEO of AHAC,
“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; (3) Payors: potential cost savings by avoiding
amputations and infections, additional surgeries, medication and
re-hospitalizations.”
Humacyte has assembled a seasoned team of 130
employees, consisting of scientists, clinical, manufacturing,
regulatory and commercial experts. Following the closing of the
transaction, Dr. Niklason and Mr. Shukla will be joined by certain
board members of Humacyte to form the Combined Company’s board of
directors.
Transaction OverviewUnder the
terms of the proposed transaction, Humacyte’s shareholders will
receive an aggregate of 80 million shares of AHAC’s Class A common
stock (the “Class A Shares”) in exchange for their existing
Humacyte shares, as contemplated by the terms of the business
combination agreement. Current shareholders of Humacyte will
exchange their shares of Humacyte for Class A Shares on a one for
one basis. In addition, Humacyte’s shareholders may receive (i) an
additional 7,500,000 Class A Shares if the 20-day VWAP of the Class
A Shares over any 30-day period equals or exceeds $15.00 and (ii)
an additional 7,500,000 Class A Shares if the 20-day VWAP of the
Class A Shares over any 30-day period equals or exceeds $20.00. In
addition to the $100 million held in AHAC’s trust account (assuming
no redemptions), an additional group of top-tier healthcare
investors has committed to participate in the transaction through a
common stock PIPE of $175 million at $10.00 per share. Assuming
that no AHAC shareholders elect to redeem their shares, it is
estimated that the current shareholders of Humacyte will own
approximately 73% of the issued and outstanding shares in the
Combined Company at closing. The Combined Company is expected to
receive gross proceeds of approximately $255 million at the closing
of the transaction assuming no redemptions. The transaction is
expected to close in the second quarter of 2021.
The transaction has been approved by each of
AHAC’s and Humacyte’s Board of Directors. The transaction is
subject to the approval of AHAC and Humacyte shareholders and other
customary conditions and is expected to close in the second quarter
of 2021.
Additional information about the transaction
will be provided in a Current Report on Form 8-K that will contain
an investor presentation to be filed by AHAC with the Securities
and Exchange Commission (“SEC”) and will be available
at www.sec.gov. In addition, AHAC intends to file a
registration statement on Form S-4 with the SEC, which will include
a proxy statement/prospectus, and will file other documents
regarding the proposed transaction with the SEC.
AdvisorsPiper 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. 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.
Webcast DetailsA pre-recorded
presentation discussing the business combination and PIPE
agreements, and associated presentation materials, can be accessed
at the following links with the passcode “AHAC”:URL:
https://dealroadshow.comDirect link:
https://dealroadshow.com/e/AHAC
About 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. is a special
purpose acquisition company formed for the purpose of effecting a
business combination with one or more businesses in the healthcare
sector. 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.
Important Information About the Merger
and Where to Find ItA full description of the terms of the
business combination will be provided in a registration statement
on Form S-4 to be filed with the SEC by AHAC that will include a
prospectus with respect to the Combined Company’s securities to be
issued in connection with the business combination and a proxy
statement with respect to the shareholder meeting of AHAC to vote
on the business combination. AHAC urges its investors,
shareholders and other interested persons to read, when available,
the preliminary 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. After the registration statement is
declared effective, the definitive proxy statement/prospectus to be
included in the registration statement will be mailed to
shareholders of AHAC as of a record date to be established for
voting on the proposed business combination. Once available,
shareholders will also be able to obtain a copy of the Form S-4,
including the proxy statement/prospectus, and other documents filed
with the SEC without charge, by directing a request to: Alpha
Healthcare Acquisition Corp., Attn: Secretary, 1177 Avenue of the
Americas, 5th Floor, New York, New York 10036. The
preliminary and definitive proxy statement/prospectus to be
included in the registration statement, once available, can also be
obtained, without charge, at the SEC’s website (www.sec.gov).
Participants in the
SolicitationAHAC 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 will be set forth in the registration
statement containing the proxy statement/prospectus for the
proposed business combination when it is filed with the SEC. 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 proposed business combination, including the timing and
structure of the business combination, the proceeds of the business
combination, the initial market capitalization of the Combined
Company and the benefits of the business combination, as well as
statements about the potential attributes and benefits of
Humacyte’s product candidates and the format and timing of
Humacyte’s product development activities and clinical trials. 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 ability to complete the
business combination due to the failure to obtain approval from
Alpha Healthcare Acquisition Corp.’s shareholders or satisfy other
closing conditions in the Business Combination Agreement, the
occurrence of any event that could give rise to the termination of
the Business Combination Agreement, the ability to recognize the
anticipated benefits of the business combination, the outcome of
any legal proceedings that may be instituted against Alpha
Healthcare Acquisition Corp. or Humacyte following announcement of
the proposed business combination and related transactions, the
impact of COVID-19 on Humacyte’s business and/or the ability of the
parties to complete the business combination, the ability to obtain
or maintain the listing AHAC’s common stock on Nasdaq following the
proposed business combination, costs related to the proposed
business combination, changes in applicable laws or regulations,
the possibility that Alpha Healthcare Acquisition Corp. or Humacyte
may be adversely affected by other economic, business, and/or
competitive factors, and other risks and uncertainties, including
those to be included under the header “Risk Factors” in the
registration statement on Form S-4 to be filed by AHAC with the SEC
and those included under the header “Risk Factors” in the final
prospectus of AHAC related to its initial public offering. Most of
these factors are outside of AHAC’s and 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.
Non-SolicitationThis press
release is not a proxy statement or solicitation of a proxy,
consent or authorization with respect to any securities or in
respect of the proposed business combination and shall not
constitute an offer to sell or a solicitation of an offer to buy
any securities nor shall there be any sale of securities in any
state or jurisdiction in which such offer, solicitation, or sale
would be unlawful prior to registration or qualification under the
securities laws of any such state or jurisdiction. No offer of
securities shall be made except by means of a prospectus meeting
the requirements of the Securities Act.
Humacyte Investor Contact:Doug
BlankenshipCFO, Humacytedblankenship@humacyte.com
Humacyte Media Contacts:Juliana
BlumEVP, Commercialblum@humacyte.com
Heather Andersonhanderson@6degreespr.com
AHAC Contact:Patrick
SturgeonChief Financial Officerinfo@alphaspac.com
Photos accompanying this announcement are
available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/93acecc5-e5e0-4e2c-a8b4-8ee840ee07a8https://www.globenewswire.com/NewsRoom/AttachmentNg/5e1a6bdc-25e8-4c05-92b9-4c44f29cc6ae
A video accompanying this announcement is
available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/379a8fa4-5916-483d-8b29-da596acbae13
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