Portfolio Company Transaction Update
06/07/2022 07:00
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RNS Number : 4357R RTW Venture Fund Limited 06 July 2022
LEI: 549300Q7EXQQH6KF7Z84
6 July 2022
RTW Venture Fund Limited
Portfolio Company Transaction Update
· Orchestra BioMed™, a portfolio company, announces strategic
collaboration, closing of $110 million private equity financing and plans to
list on Nasdaq through merger with RTW-sponsored Health Sciences Acquisitions
Corporation 2
· Orchestra BioMed™ announced a strategic collaboration with
Medtronic to develop BackBeat Cardiac Neuromodulation Therapy™ as potential
integrated hypertension treatment for cardiac pacemaker patients
· Investors in $110 million Series D financing include Medtronic
and Terumo as well as lead investor RTW Investments
· Business combination with Health Sciences Acquisitions
Corporation 2 (Nasdaq: HSAQ) (the "Business Combination"); upon closing, the
common stock of the combined company is expected to be listed on Nasdaq under
the ticker symbol "OBIO"; Business Combination is supported by $20 million in
total forward purchase agreements and an up to $50 million backstop agreement
· Business Combination and completed private equity financing are
structured to ensure total gross proceeds of a minimum of $180 million, which
is expected to fund the combined company into 2026 based on current plans and
estimates
RTW Venture Fund Limited (the "Company"), a London Stock Exchange-listed
investment fund focused on identifying transformative assets with high growth
potential across the life sciences sector, is pleased to note the announcement
by its portfolio company Orchestra BioMed™ ("Orchestra Biomed") of multiple
significant financial transactions:
· A global strategic collaboration between Orchestra BioMed and
Medtronic to develop Orchestra BioMed BackBeat Cardiac Neuromodulation
Therapy™ as a potential treatment for hypertension in patients who are
indicated for a cardiac pacemaker.
· The closing of Orchestra BioMed's $110 million Series D
financing, including investments by Medtronic, funds managed by RTW
Investments, LP ("RTW or the Investment Manager"), Perceptive Advisors, Terumo
Corporation, SternAegis Ventures and other investors. The Series D financing
was not contingent on the consummation of the Business Combination.
· A definitive Business Combination agreement between Orchestra
BioMed and HSAC2, which is structured to provide a minimum of $70 million in
gross proceeds to the combined company at closing, and up to $160 million in
the event of no redemptions by HSAC2 shareholders. The Business Combination
agreement includes $20 million in total forward purchase agreements from
Medtronic and RTW (an affiliate of HSAC2's sponsor), as well as an up to $50
million trust backstop agreement with RTW. The combined company is expected to
have a fully diluted pro forma market cap of $407 million assuming no
redemptions and $317 million assuming the minimum gross cash condition is met.
The combined company's pro forma fully diluted enterprise value is expected to
be $158 million. Upon closing of the transaction, the combined company will be
named Orchestra BioMed Holdings, Inc. ("Orchestra BioMed Holdings") and will
be led by David Hochman, Chairman, Chief Executive Officer, and Co-founder of
Orchestra BioMed. The common stock of the combined company will be listed on
Nasdaq under the ticker symbol "OBIO".
· On a pro forma basis, Orchestra BioMed Holdings is expected to
receive a minimum of $180 million in gross proceeds from the Business
Combination and Series D financing. Assuming the minimum pro forma cash
balance, the combined company is expected to have sufficient capital to fund
operations into 2026 based on current plans and estimates.
"We are pleased to report that our SPAC, Health Sciences Acquisition
Corporation 2, and Orchestra BioMed announced a deal to merge. Orchestra
simultaneously entered a partnership with Medtronic to develop Orchestra's
BackBeat Cardiac Neuromodulation Therapy. BackBeat has successfully lowered
blood pressure in two Phase 2 hypertension trials in patients with cardiac
pacemakers. As the market leader in pacemakers, we think Medtronic is an
ideal partner. The combined company would have a favourable enterprise value
of roughly $150M and the capital needed to execute on Phase 3 trials. We
believe success could translate to a multi-hundred-million-dollar annual
royalty opportunity to Orchestra. "
Stephanie Sirota, Chief Business Officer at the Investment Manager
The full text of the announcement is contained below.
For Further Information
RTW Investments, LP
+1 (646) 343 9280
Stephanie Sirota, Chief Business Officer
Woody Stileman, Managing Director, Strategic Partnerships
Buchanan
+44 (0)20 7466 5107
Charles Ryland
Henry Wilson
George Beale
About RTW Venture Fund Limited:
RTW Venture Fund Limited (LSE: RTW & RTWG) is an investment fund focused
on identifying transformative assets with high growth potential across the
life sciences sector. Driven by a long-term approach to support innovative
businesses, RTW Venture Fund invests in companies developing next-generation
therapies and technologies that can significantly improve patients' lives.
RTW Venture Fund Limited is managed by RTW Investments, LP, a leading
healthcare-focused entrepreneurial investment firm with deep scientific
expertise and a strong track record of supporting companies developing
life-changing therapies.
Visit the RTW website at www.rtwfunds.com
(https://protect.mimecast-offshore.com/s/eY8OCgLEp4SlY4JEFN_vEF) for more
information.
***********
The information in this announcement may include forward-looking statements,
which are based on the current expectations and projections about future
events, and in certain cases can be identified by the use of terms such as
"may", "will", "should", "expect", "anticipate", "project", "estimate",
"intend", "continue", "target", "believe" (or the negatives thereon) or other
variations thereon or comparable terminology. These forward-looking
statements, as well as those included in any related materials, are subject to
risks, uncertainties and assumptions about the Company and/or its underlying
investments, including, among other things, the development of the applicable
entity's business, trends in its operating industry, expected use of financing
proceeds and future capital expenditures and acquisitions. In light of these
risks, uncertainties and assumptions, the events in the forward-looking
statements may not occur.
The information contained in this announcement is given at the date of its
publication (unless otherwise marked). No reliance may be placed for any
purpose whatsoever on the information or opinions contained in this
announcement or on its completeness, accuracy or fairness.
***********
Orchestra BioMed™ Announces Strategic Collaboration, Closing of $110 Million Private Equity Financing and Plans to List on Nasdaq Through Merger with Health Sciences Acquisitions Corporation 2
Strategic collaboration with Medtronic to develop BackBeat Cardiac
Neuromodulation Therapy™ as potential integrated hypertension treatment for
cardiac pacemaker patients
Investors in $110 million Series D financing include Medtronic and Terumo as
well as lead investor RTW Investments and founding investor Perceptive
Advisors
Business combination with Health Sciences Acquisitions Corporation 2 (Nasdaq:
HSAQ) (the "Business Combination"); upon closing, the common stock of the
combined company is expected to be listed on Nasdaq under the ticker symbol
"OBIO"; Business Combination is supported by $20 million in total forward
purchase agreements and an up to $50 million backstop agreement
Business Combination and completed private equity financing are structured to
ensure total gross proceeds of a minimum of $180 million, which is expected to
fund the combined company into 2026 based on current plans and estimates
NEW HOPE, Pa. and NEW YORK, July 05, 2022 (GLOBE NEWSWIRE) -- Orchestra
BioMed™, Inc. ("Orchestra BioMed"), a biomedical company accelerating
high-impact technologies to patients through risk-reward sharing partnerships,
and Health Sciences Acquisitions Corporation 2 ("HSAC2") today announced
multiple significant transactions including:
· A global strategic collaboration between Orchestra BioMed and
Medtronic to develop Orchestra BioMed BackBeat Cardiac Neuromodulation
Therapy™ (CNT™) as a potential treatment for hypertension in patients who
are indicated for a cardiac pacemaker.
· The closing of Orchestra BioMed's $110 million Series D
financing, including investments by Medtronic, funds managed by RTW
Investments, LP ("RTW"), Perceptive Advisors, Terumo Corporation ("Terumo"),
SternAegis Ventures and other investors. The Series D financing was not
contingent on the consummation of the Business Combination.
· A definitive Business Combination agreement between Orchestra
BioMed and HSAC2, which is structured to provide a minimum of $70 million in
gross proceeds to the combined company at closing, and up to $160 million in
the event of no redemptions by HSAC2 shareholders. The Business Combination
agreement includes $20 million in total forward purchase agreements from
Medtronic and RTW (an affiliate of HSAC2's sponsor and a leading life sciences
investment firm), as well as an up to $50 million trust backstop agreement
with RTW. The combined company is expected to have a fully diluted pro forma
market cap of $407 million assuming no redemptions and $317 million assuming
the minimum gross cash condition is met. The combined company's pro forma
fully diluted enterprise value is expected to be $158 million. Upon closing of
the transaction, the combined company will be named Orchestra BioMed Holdings,
Inc. ("Orchestra BioMed Holdings" or the "Company") and will be led by David
Hochman, Chairman, Chief Executive Officer, and Co-founder of Orchestra
BioMed. The common stock of the combined company will be listed on Nasdaq
under the ticker symbol "OBIO".
· On a pro forma basis, Orchestra BioMed Holdings is expected to
receive a minimum of $180 million in gross proceeds from the Business
Combination and Series D financing. Assuming the minimum pro forma cash
balance, the combined company is expected to have sufficient capital to fund
operations into 2026 based on current plans and estimates.
"These significant transactions further validate the potential of Orchestra
BioMed's flagship development programs and our novel partnership-enabled
business model. As the global leader in advanced cardiac pacing therapies,
Medtronic is the ideal company to help us develop BackBeat CNT for the
treatment of hypertension, which is remarkably common and drives significant
health risk in the pacemaker population," said David Hochman, Chairman, CEO
and Co-Founder of Orchestra BioMed. "This new collaboration along with our
established strategic partnership with Terumo for the development and
commercialization of Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the
treatment of artery disease exemplify our commitment to developing potential
high-impact medical innovations with global medical technology leaders. The
capital proceeds from our Series D financing and planned Business Combination
provide Orchestra BioMed with a substantial financial runway and position us
to achieve major milestones."
"RTW is proud to lead these transactions, which we believe will enable
Orchestra BioMed to further advance its BackBeat CNT and Virtue SAB programs.
A recent double-blind, randomized pilot study published in the Journal of the
American Heart Association
(https://www.globenewswire.com/Tracker?data=koFtAPeGMKJwEAgzi1KQnwAysHgB6uadIqkE5K6J0VK_U5OGMLyrjTNDvXVKE0FAvN9IdZE2hmdJm-alDmoJ_K2PdnyQsDwKLyO0Y9X1J1GU_-svE9dOuJpWu1pAqzVIvDnB7KdjekxJVl-3-7J3UbBydGxEHpkvMHs-6yIZEmgerw-mCz-VGBI771EdI0LChp-8O2-AO4QrY88v54EUwd1O1ClbR80VF03wiq0Ac0YgxBsXNnwvsf5bQnAhmzfmH5wFegIo7L8i7ButALWAwB6cFXdSfyhfO-femaYPKuVcZgD4BWkTZ0VrBfj0Bfz-)
(JAHA)1 showed that BackBeat CNT drove statistically significant and
clinically meaningful reductions in blood pressure in its target patient
population. These data support Orchestra BioMed's plans to further investigate
the potential for this therapy via a global pivotal study in collaboration
with Medtronic," said Roderick Wong, M.D., Managing Partner and Chief
Investment Officer of RTW Investments, LP. "With two partnered programs
expected to commence pivotal trials in 2023, we believe Orchestra BioMed is
poised for success."
About BackBeat CNT and the Strategic Collaboration with Medtronic
BackBeat CNT is an investigational bioelectronic treatment designed to lower
blood pressure. It is compatible with standard pacemakers and has been
evaluated in pilot studies in patients with hypertension who also are
indicated for pacemakers. It is estimated that more than 70% of the
approximately 1.1 million people globally who are implanted with cardiac
pacemakers each year are also diagnosed with hypertension2.
The recent peer-reviewed, double-blind, randomized pilot study, MODERATO II,
showed that patients treated with the BackBeat CNT experienced net reductions
of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg
in office systolic blood pressure (oSBP) when compared to control patients at
six months. Orchestra BioMed plans to conduct a global pivotal trial to
further evaluate the safety and efficacy of the BackBeat CNT in lowering blood
pressure in a similar target population of patients who have been indicated
for, and recently received, a cardiac pacemaker implant. The strategic
collaboration with Medtronic will provide Orchestra BioMed with development,
clinical, and regulatory support for this planned multi-national study. Upon
regulatory approval, Medtronic will have the global rights to commercialize
BackBeat CNT-enabled pacing systems for this target population. Orchestra
BioMed will share in the revenues generated from Medtronic sales of the
BackBeat CNT-enabled pacing systems.
About Virtue SAB and the Strategic Collaboration with Terumo
Virtue SAB is a patented drug/device combination product candidate in
development for the treatment of certain forms of artery disease that is
designed to deliver a proprietary, investigational, extended-release
formulation of sirolimus, SirolimusEFR™, to the vessel wall during balloon
angioplasty without any coating on the balloon surface or the need to leave a
stent or other permanent implant in the artery. Virtue SAB demonstrated
positive three-year clinical data in coronary in-stent restenosis (ISR) in the
SABRE trial, a multi-center prospective, independent core lab-adjudicated
clinical trial of 50 patients conducted in Europe. Virtue SAB has been
granted Breakthrough Device designation by the U.S. Food and Drug
Administration ("FDA") for specific indications relating to coronary ISR,
coronary small vessel disease and peripheral artery disease below-the-knee.
Under the terms of their collaboration agreement, Orchestra BioMed and Terumo
plan to execute a global clinical program in an effort to gain regulatory
approval for commercial sale of Virtue SAB in multiple markets and
indications. Terumo made an upfront payment of $30 million to Orchestra BioMed
and Terumo will potentially make additional future clinical and regulatory
milestone payments. Orchestra BioMed will share meaningfully in future
commercial revenues of Virtue SAB through royalties and per unit payments as
the exclusive supplier of SirolimusEFR. Orchestra BioMed retains the rights to
develop and license SirolimusEFR and other technologies used in Virtue SAB for
clinical applications outside of coronary and peripheral vascular
interventions.
About the Series D Financing
Gross proceeds from Orchestra BioMed's completed Series D financing totaled
$110 million, including a $40 million investment from Medtronic, a $20 million
investment from RTW, and investments from other existing shareholders of
Orchestra BioMed including Perceptive Advisors, Terumo Corporation, SternAegis
Ventures and others. The Series D financing was not contingent on the
consummation of the Business Combination.
Orchestra BioMed, subject to certain conditions, has further access to up to
$40 million in term debt from the Avenue Venture Opportunities Fund, an
affiliate of the Avenue Capital Group.
About the Business Combination
The Business Combination is expected to close in the fourth quarter of 2022.
With the Series D financing proceeds already received by Orchestra BioMed,
upon closing of the Business Combination, Orchestra BioMed Holdings expects to
have sufficient cash to fund business operations into 2026 based on current
plans and estimates. Funding will be used to support Orchestra BioMed
Holdings' business operations including planned pivotal trials for BackBeat
CNT and Virtue SAB, which are scheduled to initiate in 2023. The Company also
plans to identify additional promising therapeutic device innovations for
potential strategic addition(s) to the Company's product development pipeline
that can be optimized using its partnership-based business model.
To ensure there is a minimum of $70 million in the HSAC2 trust account at the
time of closing to fund the Company, Medtronic and RTW are each committing $10
million to the trust account through support agreements, and RTW is providing
up to $50 million to backstop potential redemptions. Assuming no redemptions
are made, an additional $90 million may be available from HSAC2's trust
account, providing maximum gross proceeds from the Business Combination and
Series D transactions of $270 million to help fund the business.
The boards of directors of both HSAC2 and Orchestra BioMed have unanimously
approved the proposed transaction, which is subject to approval by HSAC2 and
Orchestra BioMed's stockholders and the satisfaction or waiver of certain
other customary closing conditions.
Upon closing, HSAC2's current board of directors will resign and be replaced
by Orchestra BioMed's current board of directors.
The description of the Business Combination contained herein is only a summary
and is qualified in its entirety by reference to the definitive agreement
relating to the Business Combination, a copy of which will be filed by HSAC2
with the Securities and Exchange Commission ("SEC") as an exhibit to a Current
Report on Form 8-K, which can be accessed through the SEC's website
at www.sec.gov.
(https://www.globenewswire.com/Tracker?data=swjV7gDQqhEj7lp4lSmM2nuCvhh_lCJ7p4Ah7uoFoD0EGvR-bEkyqvDc5mfq_kjnuKYckOeHyrby7cCdAhQVPA==)
Advisors
Jefferies LLC and Piper Sandler & Co. acted as Joint Lead Placement Agents
for the Series D Financing and Aegis Capital acted as Selling Agent. Jefferies
LLC is acting as lead financial advisor and a capital markets advisor to
Orchestra BioMed in relation to the proposed Business Combination. Piper
Sandler & Co. acted as strategic advisor to Orchestra BioMed with respect
to the strategic collaboration with Medtronic and is acting as a capital
markets advisor to Orchestra BioMed in relation to the proposed Business
Combination.
Chardan Capital Markets LLC and Barclays Capital Inc. are serving as financial
and capital markets advisors to HSAC2 in relation to the proposed Business
Combination.
Paul Hastings LLP is serving as legal counsel for Orchestra BioMed. Loeb &
Loeb LLP is serving as legal counsel for HSAC2.
About Orchestra BioMed
Orchestra BioMed is a biomedical company with a business model designed to
accelerate high-impact technologies to patients through risk-reward sharing
partnerships. Orchestra BioMed's partnership-enabled business model focuses on
forging strategic collaborations with leading medical device companies to
drive successful global commercialization of products it develops. Orchestra
BioMed's flagship product candidates include BackBeat Cardiac Neuromodulation
Therapy™ for the treatment of hypertension, the leading risk factor for
death worldwide, and Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the
treatment of certain forms of artery disease, the leading cause of mortality
worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one
of the largest medical device companies in the world, for development and
commercialization of BackBeat CNT for the treatment of hypertension in
pacemaker-indicated patients, and a strategic partnership with Terumo
Corporation, a global leader in medical technology, for development and
commercialization of Virtue SAB for the treatment of artery disease. Orchestra
BioMed has additional product candidates and plans to potentially expand its
product pipeline through acquisitions, strategic collaborations, licensing,
and organic development.
About HSAC2
Health Sciences Acquisitions Corporation 2 is a blank check company formed for
the purpose of effecting a merger, share exchange, asset acquisition, share
purchase, reorganization or similar business combination with one or more
businesses. The sponsor of HSAC2 is HSAC 2 Holdings, LLC, an affiliate of RTW
Investments, LP.
About RTW Investments, LP
RTW Investments, LP is a New York-based, global, full life-cycle investment
firm that focuses on identifying transformational and disruptive innovations
across the biopharmaceutical and medical technologies sectors. As a leading
partner of industry and academia, RTW combines deep scientific expertise with
a solution-oriented investment approach to advance emerging medical therapies
by building and supporting the companies and/or academics developing them. For
further information about RTW, please visit www.RTWfunds.com
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.
Important Information and Where to Find It
In connection with the transaction described herein, HSAC2 intends to file a
registration statement on Form S-4 with the SEC, which will include a proxy
statement/prospectus. Promptly after the registration statement is declared
effective by the SEC, HSAC2 will mail the definitive proxy
statement/prospectus and a proxy card to each shareholder of HSAC2 as of a
record date for the meeting of HSAC2 shareholders to be established for voting
on the proposed Business Combination. Before making any voting decision,
investors and security holders of HSAC2 are urged to read these materials
(including any amendments or supplements thereto) and any other relevant
documents in connection with the transaction that HSAC2 has filed or will file
with the SEC when they become available because they will contain important
information about HSAC2, the Company, and the transaction. The preliminary
proxy statement/prospectus, the definitive proxy statement/prospectus and
other relevant materials in connection with the transaction (when they become
available), and any other documents filed by HSAC2 with the SEC, may be
obtained free of charge at the SEC's website (www.sec.gov). The documents
filed by HSAC2 with the SEC also may be obtained free of charge upon written
request to Health Sciences Acquisitions Corporation 2, 40 10th Avenue, Floor
7, New York, NY 10014.
Participants in the Solicitation
HSAC2 and Orchestra BioMed and their respective directors and executive
officers, under SEC rules, may be deemed participants in the solicitation of
proxies of HSAC2's shareholders in connection with the proposed Business
Combination. HSAC2's shareholders and other interested persons may obtain,
without charge, more detailed information regarding the directors and officers
of HSAC2 and a description of their interests in HSAC2 in HSAC2's Annual
Report on Form 10-K for the year ended December 31, 2021, which was filed with
the SEC on March 31, 2022. Additional information regarding the interests of
each of HSAC2's and Orchestra BioMed's directors and executive officers in the
proposed Business Combination will be available in the definitive proxy
statement/prospectus when it becomes available.
No Solicitation
This 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
potential transaction and shall not constitute an offer to sell or a
solicitation of an offer to buy, or a recommendation to purchase any
securities of HSAC2 (or of the combined company) or Orchestra BioMed, nor
shall there be any sale of any such securities, investments or other specific
product 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 such state or jurisdiction. No offer of securities shall be made
except by means of a prospectus meeting the requirements of the Securities
Act of 1933, as amended.
References to Websites in this Press Release
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.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking
statements may be identified by words such as "aims," "believe," "may,"
"will," "estimate," "continue," "anticipate," "intend," "expect," "would,"
"plan," "future," "scheduled" and 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. These forward-looking statements include, but are not limited
to, statements regarding the expected timing of the closing of the Business
Combination, other statements regarding the Business Combination's effects,
prospective performance, future plans, events, expectations, performance,
objectives, estimates and forecasts of performance metrics, market
capitalization and enterprise value, projections of market opportunity, the
outlook for Orchestra BioMed's or the Company's business, the
commercialization plans for Orchestra BioMed's or the Company's products,
financial needs, anticipated timing or impact of clinical trials or data,
approvals relating to the Business Combination, the ability to complete the
Business Combination considering the various closing conditions and the
accuracy of assumptions underlying the foregoing. These statements are based
on various assumptions, whether or not identified in this press release, and
on the current expectations of HSAC2's and Orchestra BioMed's respective
management and are not predictions of actual performance. These
forward-looking statements are provided for illustrative purposes only and are
not intended to serve as, and must not be relied on by any investor as, a
guarantee, an assurance, a prediction or a definitive statement of fact or
probability. Actual events and circumstances are difficult or impossible to
predict and will differ from assumptions. Many actual events and circumstances
are beyond the control of HSAC2 and Orchestra BioMed.
These forward-looking statements are subject to a number of risks and
uncertainties, including the inability of the parties to successfully or
timely consummate the Business Combination, the risk that any required
regulatory approvals are not obtained, are delayed or are subject to
unanticipated conditions that could adversely affect the combined company or
the expected benefits of the Business Combination, if not obtained; the
failure to realize the anticipated benefits of the Business Combination;
matters discovered by the parties as they complete their respective due
diligence investigation of the other parties; the ability of the Company
following the Business Combination to maintain the listing of its shares on
Nasdaq; costs related to the Business Combination; future financial
performance of the Company following the Business Combination; expectations
regarding future expenditures of the Company following the Business
Combination; the Company's ability to execute its business plans and strategy;
the failure to satisfy the conditions to the consummation of the Business
Combination, including the approval of the definitive merger agreement by the
shareholders of HSAC2 and Orchestra BioMed; the satisfaction of the minimum
cash requirements of the definitive merger agreement following any redemptions
by HSAC2's public shareholders; the risk that HSAC2's shareholders will not
approve the extension of the August 6, 2022 deadline to complete the Business
Combination or that the Business Combination may not be completed by the
extended deadline; the outcome of any legal proceedings that may be instituted
against HSAC2 or the Company related to the Business Combination; the
attraction and retention of qualified directors, officers, employees and key
personnel of HSAC2 and Orchestra BioMed prior to the Business Combination, and
the Company following the Business Combination; the Company's ability to
design, develop, manufacture and market innovative therapies to address
cardiovascular disease and other significant medical conditions; the ability
of the Company to partner with third parties for the development of its
products and product candidates; the ability of the Company to achieve
clinical and regulatory milestones pursuant to the Terumo partnership, the
Medtronic collaboration and future partnerships; regulatory developments in
the United States and foreign countries; the ability of the Company to compete
effectively in a highly competitive market; the ability of the Company to ever
achieve significant revenues or profitability; the Company's ability to
protect and enhance its corporate reputation, brand and intellectual property;
the timing, costs, conduct, and outcome of clinical trials and future
preclinical studies and clinical trials, including the timing of the
initiation and availability of data from such trials; the timing and
likelihood of regulatory filings and approvals for product candidates; whether
regulatory authorities determine that additional trials or data are necessary
in order to obtain approval; the potential market size and the size of the
patient populations for product candidates, if approved for commercial use,
and the market opportunities for product candidates; the ability to locate and
acquire complementary products or product candidates and integrate those into
the Company's business; the uncertain effects of the COVID-19 pandemic and
other global events; and those factors set forth in documents of HSAC2 filed,
or to be filed, with SEC. The foregoing list of risks is not exhaustive.
If any of these risks materialize or our assumptions prove incorrect, actual
results could differ materially from the results implied by these
forward-looking statements. There may be additional risks that HSAC2 or
Orchestra BioMed does not presently know or HSAC2 or Orchestra BioMed
currently believes are immaterial that could also cause actual results to
differ from those contained in the forward-looking statements. In addition,
forward-looking statements reflect HSAC2's or Orchestra BioMed's current
expectations, plans and forecasts of future events and views as of the date of
this press release. HSAC2 and Orchestra BioMed anticipate that subsequent
events and developments will cause HSAC2's or Orchestra BioMed's assessments
to change. However, while HSAC2 or Orchestra BioMed may elect to update these
forward-looking statements at some point in the future, HSAC2 and Orchestra
BioMed specifically disclaim any obligation to do so, except as required by
law. These forward-looking statements should not be relied upon as
representing HSAC2's or Orchestra BioMed's assessments as of any date
subsequent to the date of this press release. Accordingly, undue reliance
should not be placed upon the forward-looking statements.
Orchestra BioMed Investor Contact:
Bob Yedid
LifeSci Advisors
(646) 597-6989
Bob@lifesciadvisors.com
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Orchestra BioMed Media Contact:
Bill Berry
Berry & Company Public Relations LLC
(212) 253-8881
bberry@berrypr.com
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RTW Investments and HSAC2 Media Contact:
Josh Baldwin
RTW Investments LP
(917) 209-9916
jjgb@rtwfunds.com
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(1) Z. Kalarus, et.al. Pacemaker-Based Cardiac Neuromodulation Therapy in
Patients with Hypertension: A Pilot Study. J Am Heart Assoc. 2021;10:
e020492. DOI: 10.1161/JAHA.120.020492
(2) Company estimates based on published sources, including National
Inpatient Survey (NIS) and National Health and Nutrition Examination Survey
(NHANES)
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