- Medera is a clinical-stage biotechnology company focused on
targeting difficult-to-treat cardiovascular diseases using a range
of next-generation gene- and cell-based approaches in combination
with bioengineered human mini-heart drug discovery and screening
technology platforms
- Transaction proceeds to accelerate three most advanced
clinical programs for the adeno-associated virus (AAV)-based gene
therapy candidates
- The combined company to have an implied initial
enterprise value of approximately $622.6
million
- Medera's founders and key shareholders have committed
approximately $22.6 million (via
conversion of all shareholders loans) for this merger, with all
existing Medera shareholders rolling 100% of their equity
- As a closing condition to the business combination, Medera
shall have at least $40 million in
available liquidity
- Anticipated closing of transaction in fourth quarter of
2024
SUMMIT,
N.J. and BOSTON,
Sept. 5,
2024 /PRNewswire/ -- Keen Vision Acquisition
Corporation ("KVAC") (Nasdaq: KVAC, KVACW) and Medera Inc.,
("Medera"), a clinical-stage biotechnology company, announced today
that they have entered into a definitive merger agreement. Upon
closing of the merger, which is expected to occur in the fourth
quarter of 2024, the combined company is to be named
Medera Inc.
Company Overview
Medera Inc. is a clinical-stage biopharmaceutical company,
focused on targeting difficult-to-treat and currently incurable
diseases by developing next-generation gene- and cell-based
approaches in combination with bioengineered human-based (including
the exclusively available mini-Heart®) screening technology
platform for disease modeling and drug discovery. Medera
operates through its two business units, Sardocor and
Novoheart.
Sardocor executes clinical development of novel next-generation
therapies for Medera. Leveraging the Novoheart human-based drug
discovery and validation platforms, as described below, Sardocor
aims to expedite the drug development and regulatory timelines for
its gene therapy and cell therapy pipeline. Sardocor has been
granted Investigational New Drug (IND) clearances from the US Food
and Drug Administration (FDA) for three ongoing adeno-associated
virus (AAV)-based cardiac gene therapy clinical trials for Heart
Failure with Reduced Ejection Fraction (HFrEF), Heart Failure with
Preserved Ejection Fraction (HFpEF) and Duchenne Muscular
Dystrophy-induced Cardiomyopathy (DMD-CM). In addition, Sardocor's
pipeline also includes four preclinical gene therapy and three
preclinical small molecule candidates for a range of cardiac,
pulmonary and vascular diseases.
Sardocor is currently focused on its three most advanced
clinical programs, which are AAV-based gene therapy candidates:
- SRD-001 is intended to treat patients with HFrEF, a
prevalent form of heart disease that accounts for half of an
estimated 64.3 million heart failure cases worldwide. With an open
IND clearance from the FDA, SRD-001 is being evaluated in an
ongoing Phase 1/2a clinical trial (called MUSIC-HFrEF; NCT0470384).
To date, six patients have been infused with SRD-001 in Cohort A
(low-dose 3x1013 vg per patient) and one patient has
been infused in Cohort B (high-dose 4.5x1013 vg per
patient). A clinical update of this trial was featured in a
late-breaking oral presentation at the American Society of Gene
& Cell Therapy (ASGCT) in May
2024. Clinically meaningful improvements in multiple metrics
of heart function and patient health were observed following
delivery of SRD-001 (e.g., NYHA class, 6MW, LVEF and
pro-BNP). Sardocor expects to complete the Phase 1/2a
portion of the ongoing trial in the fourth quarter and commence an
international randomized Phase 2b
portion shortly after.
- SRD-002 is intended to treat patients with HFpEF,
another prevalent form of heart failure accounting for the
remaining half of all heart failure cases that currently still lack
disease-modifying therapeutics. With an open IND and Fast Track
Designation from the FDA, SRD-002 is being evaluated in an ongoing
First-In-Human Phase 1/2a clinical trial (called MUSIC-HFpEF;
NCT06061549). To date, five patients have been infused with SRD-002
in Cohort A (low-dose 3x1013 vg per patient) and
Sardocor has been cleared to dose patients in Cohort B (high-dose
4.5x1013 vg per patient). Improvements in cardiovascular
performance were observed in the first three patients at six months
with additional data being collected. Sardocor expects to complete
patient enrolment in both cohorts of the Phase 1/2a clinical trial
by the end of 2024 and to provide an interim data readout in the
first half of 2025.
- SRD-003 is intended to treat patients (aged 18 or
above) with DMD-CM, for which there is still no cure. Almost
all DMD patients eventually die from DMD-CM. With the FDA's
IND clearance and Orphan Drug Designation, SRD-003 is currently
being evaluated in an ongoing First-In-Human Phase 1/2a clinical
trial (called MUSIC-DMD; NCT06224660). Sardocor expects to dose the
first patient in the fourth quarter of 2024.
Using its proprietary intracoronary infusion methodology,
Sardocor delivers its gene therapy candidates directly via blood
vessels to the cardiac ventricular muscle cells as an out-patient
procedure. This minimally invasive technique allows the delivery of
optimal and least amount of drug products to achieve efficient
transduction and improved efficacy while avoiding side effects
(such as those typically seen with systemic delivery of very large
AAV doses).
With its proprietary, award-winning human mini-Heart® screening
technology platform, Novoheart conducts preclinical disease
modelling and drug discovery for Medera, aiming to create, expand,
validate, and optimize Medera's therapeutic pipeline (under
Sardocor). Novoheart's versatile technology platform provides a
range of state-of-the-art automation hardware and software as well
as screening services, for human-specific disease modelling,
therapeutic target discovery and validation, drug toxicity and
efficacy screening, and dosage optimization carried out in the
context of healthy and/or diseased human heart chambers and
tissues. These are free from species-specific differences and in 3D
configurations that accurately reflect the native human heart's
physiology or pathophysiology. These properties substantially
improve success rates and reduce development cost and time in
accordance with the FDA Modernization Act 2.0. Global
pharmaceutical and academic leaders are using Novoheart's
technology platform their drug discovery and development purposes.
The Novoheart platform has facilitated and accelerated the
development and regulatory approvals of Sardocor's lead therapeutic
candidates that are currently in clinical trials.
Management Comments
"Medera is uniquely positioned for sustainable growth with its
one-of-a-kind technology platform and a broad portfolio of clinical
and preclinical candidates, three of which are leading gene therapy
candidates with ongoing FDA clinical trials. In line with FDA's
Modernization Act 2.0, Medera's use of its bioengineered
human-based technology in drug discovery and development processes
promotes more accurate drug testing and fewer animal killings,
which are environmentally and socially responsible. Medera's
collaboration and licensing arrangements now in place with global
pharmaceutical leaders provide validation for its achievements,"
remarked Kenneth KC Wong, Chairman and Chief Executive Officer of
KVAC.
"Achieving a Nasdaq listing will allow Medera to be better
positioned for advancing our various clinical and preclinical
programs, enabling more efficient development aimed at bringing
novel therapeutic solutions to patients with unmet needs," stated
Ronald Li, PhD, Chief Executive
Officer and Founder of Medera.
"With this business combination, Sardocor will be well
positioned to potentially expediate its three clinical trials for
our lead gene therapy candidates in HFrEF, HFpEF and DMD-CM.
By utilizing our intra-coronary methodology to directly deliver our
gene therapy candidates into the heart, our approach has the
potential to significantly lower the dosage compared other
therapies that typically utilize systemic delivery. We also
plan to accelerate our timetable to apply for an Investigational
New Drug (IND) and the start of the Phase 1 trial for our next gene
therapy candidate," said Roger
Hajjar, MD, President, Chief Medical Officer and co-Founder
of Medera.
Transaction Overview
This merger values Medera at a pre-money valuation of
$622.6 million. Cash proceeds from
the transactions contemplated by the merger agreement may consist
of up to approximately $149.50
million of cash currently held in KVAC's trust account
(before any redemptions by KVAC's stockholders).
The transaction includes a management incentive plan that the
parties intend to tie to the successful commercialization
of the three clinical stage assets, reflecting an alignment of
interest with shareholders
The transaction, which has been unanimously approved by the each
of the boards of directors of KVAC and Medera, is subject to, among
other customary closing conditions, approval by the shareholders of
KVAC and of Medera, with the holders of a majority of the votes of
both companies required to approve the transaction having provided
commitments to approve the transaction. The transaction is expected
to close in the fourth quarter of 2024.
A more detailed description of the transaction terms and a copy
of the merger agreement will be included in a current report on
Form 8-K to be filed by KVAC with the United States Securities and
Exchange Commission (the "SEC"). A registration statement (which
will contain a proxy statement/ prospectus) will be filed with the
SEC in connection with the transaction.
About Keen Vision Acquisition Corporation
Keen Vision Acquisition Corp ("KVAC"), listed on Nasdaq, is a
blank check company incorporated for the purpose of effecting a
merger, share exchange, asset acquisition, share purchase,
reorganization or similar business combination with one or more
businesses or entities. KVAC is focused on biotechnology, consumer
goods or agriculture opportunities, which are also evaluated on
their sustainability, environmental, social, and corporate
governance ("ESG") imperatives. EF Hutton LLC and Brookline Capital
Markets, a division of Arcadia Securities, LLC, are serving as
Capital Markets Advisors for KVAC.
www.kv-ac.com
About Medera Inc.
Medera is a clinical-stage biopharmaceutical company focused on
eradicating difficult-to-treat cardiovascular diseases with
significant unmet needs, using a range of next-generation gene- and
cell-based approaches in combination with bioengineered human-based
technology (including mini-Heart®) platform. Medera operates
via two business units Sardocor and Novoheart.
www.medera.bio
Forward-Looking Statements
Certain statements included in this press release are not
historical facts but are forward-looking statements for purposes of
the safe harbor provisions under the United States Private
Securities Litigation Reform Act of 1995. All statements other than
statements of historical facts contained in this press release are
forward-looking statements. Any statements that refer to
projections, forecasts or other characterizations of future events
or circumstances, including any underlying assumptions, are also
forward-looking statements. In some cases, you can identify
forward-looking statements by words such as "estimate," "plan,"
"project," "forecast," "intend," "expect," "anticipate," "believe,"
"seek," "strategy," "future," "opportunity," "may," "target,"
"should," "will," "would," "will be," "will continue," "will likely
result," "preliminary," or similar expressions that predict or
indicate future events or trends or that are not statements of
historical matters, but the absence of these words does not mean
that a statement is not forward-looking. Forward-looking statements
include, without limitation, KVAC's, Medera's, or their respective
management teams' expectations concerning the outlook for their or
Medera's business, productivity, plans, and goals for future
operational improvements and capital investments, operational
performance, future market conditions, or economic performance and
developments in the capital and credit markets and expected future
financial performance, including expected net proceeds, expected
additional funding, the percentage of redemptions of KVAC's public
shareholders, growth prospects and outlook of Medera' operations,
individually or in the aggregate, including the achievement of
project milestones, commencement and completion of commercial
operations of certain of Medera's projects, as well as any
information concerning possible or assumed future results of
operations of Medera. Forward-looking statements also include
statements regarding the expected benefits of the transactions
contemplated by the merger ("Transaction"). The forward-looking
statements are based on the current expectations of the respective
management teams of Medera and KVAC, as applicable, and are
inherently subject to uncertainties and changes in circumstance and
their potential effects. There can be no assurance that future
developments will be those that have been anticipated. These
forward-looking statements involve a number of risks, uncertainties
or other assumptions that may cause actual results or performance
to be materially different from those expressed or implied by these
forward-looking statements. These risks and uncertainties include,
but are not limited to, (i) the risk that the Transaction may not
be completed in a timely manner or at all, which may adversely
affect the price of KVAC's securities; (ii) the risk that the
Transaction may not be completed by KVAC's business combination
deadline and the potential failure to obtain an extension of the
business combination deadline if sought by KVAC; (iii) the failure
to satisfy the conditions to the consummation of the Transaction,
including the adoption of the Merger Agreement by the shareholders
of KVAC and the receipt of certain regulatory approvals; (iv)
market risks; (v) the occurrence of any event, change or other
circumstance that could give rise to the termination of the Merger
Agreement; (vi) the effect of the announcement or pendency of the
Transaction on Medera's business relationships, performance, and
business generally; (vii) the outcome of any legal proceedings that
may be instituted against Medera or KVAC related to the Merger
Agreement or the Transaction; (viii) failure to realize the
anticipated benefits of the Transaction; (ix) the inability to
maintain the listing of KVAC's securities or to meet listing
requirements and maintain the listing of Medera's securities on
Nasdaq; (x) the inability to implement business plans, forecasts,
and other expectations after the completion of the Transaction,
identify and realize additional opportunities, and manage its
growth and expanding operations; (xi) risks related to Medera's
ability to develop, license or acquire new therapeutics; (xii) the
risk that Medera will need to raise additional capital to execute
its business plan, which may not be available on acceptable terms
or at all; (xiii) the risk of product liability or regulatory
lawsuits or proceedings relating to Medera's business; (xiv)
uncertainties inherent in the execution, cost, and completion of
preclinical studies and clinical trials; (xv) risks related to
regulatory review, and approval and commercial development; (xvi)
risks associated with intellectual property protection; (xvii)
Medera's limited operating history and risk that it may never
successfully commercialise its products; (xviii) Medera expects to
continue to incur significant losses and may never achieve or
maintain profitability; and (xix) the risk that additional
financing in connection with the Transaction may not be raised on
favorable terms. The foregoing list is not exhaustive, and there
may be additional risks that neither KVAC nor Medera presently
knows or that KVAC and Medera currently believe are immaterial. You
should carefully consider the foregoing factors, any other factors
discussed in this press release and the other risks and
uncertainties described in the "Risk Factors" section of KVAC's
Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC
on March 29, 2024, the risks to be
described in the registration statement, which will include a
preliminary proxy statement/prospectus, and those discussed and
identified in filings made with the SEC by KVAC from time to time.
Medera and KVAC caution you against placing undue reliance on
forward-looking statements, which reflect current beliefs and are
based on information currently available as of the date a
forward-looking statement is made. Forward-looking statements set
forth in this press release speak only as of the date of this press
release. Neither Medera nor KVAC undertakes any obligation to
revise forward-looking statements to reflect future events, changes
in circumstances, or changes in beliefs. In the event that any
forward-looking statement is updated, no inference should be made
that Medera or KVAC will make additional updates with respect to
that statement, related matters, or any other forward-looking
statements. Any corrections or revisions and other important
assumptions and factors that could cause actual results to differ
materially from forward-looking statements, including discussions
of significant risk factors, may appear, up to the consummation of
the Transaction, in KVAC's public filings with the SEC, and which
you are advised to review carefully.
Important Information for Investors and Shareholders
In connection with the Transaction, KVAC and Medera intend to
file with the SEC a registration statement, which will include a
prospectus with respect to the securities to be issued in
connection with the Transaction and a proxy statement to be
distributed to holders of KVAC's common shares in connection with
KVAC's solicitation of proxies for the vote by KVAC's shareholders
with respect to the Transaction and other matters to be described
in the Registration Statement (the "Proxy Statement"). After the
SEC declares the registration statement effective, KVAC plans to
mail copies to shareholders of KVAC as of a record date to be
established for voting on the Transaction. This press release does
not contain all the information that should be considered
concerning the Transaction and is not a substitute for the
registration statement, Proxy Statement or for any other document
that KVAC may file with the SEC. Before making any investment or
voting decision, investors and security holders of KVAC are urged
to read the registration statement and the Proxy Statement, and any
amendments or supplements thereto, as well as all other relevant
materials filed or that will be filed with the SEC in connection
with the Transaction as they become available because they will
contain important information about, Medera, KVAC and the
Transaction.
Investors and security holders will be able to obtain free
copies of the registration statement, the Proxy Statement and all
other relevant documents filed or that will be filed with the SEC
by KVAC through the website maintained by the SEC at www.sec.gov.
In addition, the documents filed by KVAC may be obtained free of
charge from KVAC's website at https://www.kv-ac.com or by directing
a request to info@kv-ac.com. The information contained on, or that
may be accessed through, the websites referenced in this press
release is not incorporated by reference into, and is not a part
of, this press release.
Participants in the Solicitation
KVAC, Medera and their respective directors, executive officers
and other members of management and employees may, under the rules
of the SEC, be deemed to be participants in the solicitations of
proxies in connection with the Transaction. For more information
about the names, affiliations and interests of KVAC's directors and
executive officers, please refer to KVAC's annual report on Form
10-K filed with the SEC on March 29,
2024, which can be found at
https://www.sec.gov/ix?doc=/Archives/edgar/data/1889983/000121390024027973/ea0201104-10k_keenvision.htm and
registration statement, Proxy Statement and other relevant
materials filed with the SEC in connection with the Transaction
when they become available. Additional information regarding the
participants in the proxy solicitation and a description of their
direct and indirect interests, which may, in some cases, be
different than those of KVAC's shareholders generally, will be
included in the registration statement and the Proxy Statement and
other relevant materials when they are filed with the SEC when they
become available. Shareholders, potential investors and other
interested persons should read the registration statement and the
Proxy Statement and other such documents carefully, when they
become available, before making any voting or investment decisions.
You may obtain free copies of these documents from the sources
indicated above.
No Offer or Solicitation
This communication shall not constitute an offer to sell or the
solicitation of an offer to buy any securities, nor shall there be
any sale of securities in any jurisdiction in which such offer,
solicitation, or sale would be unlawful prior to registration or
qualification under the securities laws of any such jurisdiction.
No offering of securities in the Transaction shall be made except
by means of a prospectus meeting the requirements of Section 10 of
the Securities Act of 1933, as amended.
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SOURCE Keen Vision Acquisition Corporation; Medera Inc.
