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United States securities and exchange commission logo
November 9, 2022
Roderick Wong
Chief Executive Officer
Health Sciences Acquisitions Corp 2
40 10th Avenue, Floor 7
New York, NY 10014
Re: Health Sciences
Acquisitions Corp 2
Amendment No. 2 to
Registration Statement on Form S-4
Filed October 24,
2022
File No. 333-266660
Dear Roderick Wong:
We have reviewed your amended registration statement and have the
following
comments. In some of our comments, we may ask you to provide us with
information so we
may better understand your disclosure.
Please respond to this letter by amending your registration
statement and providing the
requested information. If you do not believe our comments apply to your
facts and
circumstances or do not believe an amendment is appropriate, please tell
us why in your
response.
After reviewing any amendment to your registration statement and
the information you
provide in response to these comments, we may have additional comments.
Unless we note
otherwise, our references to prior comments are to comments in our
October 12, 2022 letter.
Amendment No. 2 to Registration Statement on Form S-4
Summary of the Proxy Statement/Prospectus
Summary Risk Factors
Risks Related to Orchestras Business and Products, page 40
1. We acknowledge your
response to prior comment 11, and note that you indicate on page
229 that five events in
three patients were adjudicated as possibly related to the BackBeat
CNT device.
Accordingly, please revise the 11th bullet on page 41 to explain that there
have been serious
adverse events in Orchestra's prior clinical trials, including five events
in three patients that
were adjudicated as possibly related to the BackBeat CNT device.
Roderick Wong
FirstName LastNameRoderick Wong
Health Sciences Acquisitions Corp 2
Comapany 9,
November NameHealth
2022 Sciences Acquisitions Corp 2
November
Page 2 9, 2022 Page 2
FirstName LastName
Please also further revise your risk factor on page 57 to state this
information, and on page
229, clarify what types of events were adjudicated as possibly device
related (e.g., cardiac
events).
Risk Factors
The Domestication may be a taxable event for U.S. Holders of HSAC2 Ordinary
Shares, page
101
2. We refer to our prior comment 2 and acknowledge your response. Please
expand this risk
factor to explain that counsel is only providing a "should" opinion
and explain the
uncertainties that prevent it from being able to provide a "will"
opinion. In addition, in the
"Material U.S. Federal Income Tax Consequences" section, please also
provide similar
disclosure to clearly explain that counsel is only providing a
"should" opinion and not a
"will" opinion.
Business of Orchestra, page 219
3. We acknowledge your revised disclosures in response to prior comment
3, but note that
some of your statements remain conclusory in nature. Please further
revise accordingly.
You may reference objective trial data or state that primary efficacy
endpoints were met.
In addition, balance your references to your trial results with
cautionary language
regarding the preliminary nature of the results.
Business of Orchestra
Product Pipeline, page 220
4. We acknowledge your revised disclosures in response to prior comment
5, and
acknowledge your statement regarding the inability to predict
regulatory approval
timelines. However, as previously stated, please revise your "Next
Milestones & Expected
Timing" column to provide additional context regarding the timing to
investors. With
respect to each trial, please ensure that you specifically state if
the referenced dates refer
to the expected initiation of the trial and whether an IDE (or its
foreign equivalent) has
been submitted already or to be submitted in the future. In addition,
please clearly disclose
in the table your timing expectations with respect to minimum
requirements for each of
your planned trials. For example, if you are expecting that it will
take a minimum of five
to six years to enroll patients and complete the trial (before taking
into account regulatory
approval timing or delays), please revise to provide this information.
Results of Operations
Comparison of the Six Months Ended June 30, 2021 and 2022, page 312
5. We acknowledge your response to bullet 1 of comment 13. Please revise
your existing
disclosure about the changes in research and development expenses to
quantify the
amounts related to Virtue SAB product candidate, as the Virtue SAB
product candidate is
the majority of the research and development expenses and appears to
be the driver of the
Roderick Wong
Health Sciences Acquisitions Corp 2
November 9, 2022
Page 3
changes in this line item. Similarly revise your Comparison of the Years
Ended December
31, 2020 and 2021.
General
6. We note your statement in footnote 2 to your filing fee table that you
are registering on
this S-4 up to 5 million Ordinary Shares to be issued pursuant to the
Backstop Agreement.
Please explain why you believe it is appropriate to register these shares
on this registration
statement. In this regard, it appears from your disclosures that the
shares under the
Backstop Agreement will be issued immediately prior to the Transactions,
and therefore it
appears that the RTW Funds have been essentially offered shares in the
continuing
entity Orchestra BioMed Holdings, Inc. on a private basis. In addition,
it appears that
shares to be issued under the forward purchase agreement with Medtronic
are also being
registered hereunder. Please also similarly explain why it would be
appropriate to register
such shares hereunder.
You may contact Christine Torney at 202-551-3652 or Kevin Vaughn at
202-551-3494 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Doris Stacey Gama at 202-551-3188 or Dorrie Yale at 202-551-8776 with
any other
questions.
Sincerely,
FirstName LastNameRoderick Wong Division of
Corporation Finance
Office of
Industrial Applications and
Comapany NameHealth Sciences Acquisitions Corp 2
Services
November 9, 2022 Page 3
cc: Janeane Ferrari, Esq.
FirstName LastName