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United States securities and exchange commission logo
October 12, 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. 1 to
Registration Statement on Form S-4
Filed September 23,
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
September 3, 2022 letter.
Amendment No. 1 to Registration Statement on Form S-4
Q: How will the Initial Shareholders vote?, page 16
1. We acknowledge your
revised disclosures in response to prior comment 4. Please also
revise to explain
whether the various support agreements will be revised to reflect the
revised disclosures.
Material U.S. Federal Income Tax Consequences
U.S. Federal Income Tax Consequences of the Domestication. . ., page 145
2. We note your response
to previous comment 14. If counsel is providing a "should"
opinion, please amend
to clearly state this fact, explain the reason for counsel's inability to
provide a "will"
opinion, describe the degree of uncertainty in the opinion, and provide
Roderick Wong
FirstName LastNameRoderick Wong
Health Sciences Acquisitions Corp 2
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risk and other appropriate disclosure. In addition, please revise your
short-form opinion so
that the material tax consequence is clearly disclosed other than the
issue giving rise to the
uncertainty. Refer to Section III.C.4 of Staff Legal Bulletin No. 19.
Business of Orchestra, page 221
3. We acknowledge your revised disclosures in response to prior comment
16. Please further
revise to avoid conclusory statements regarding your trials or your
product candidates'
performance. For example, your disclosure continues to refer to
"compelling" or
"promising" trial data. You may revise to discuss objective data, and
balance your
discussion of trial results with cautionary language regarding the
preliminary nature of the
results.
Company, page 221
4. We note your response to comment 17. Please amend your filing to
include a description
of how Orchestra estimates a market opportunity of 3.2 million
procedures valued at
approximately $3 billion for Virtue SAB to provide investors with
context regarding these
amounts.
Product Pipeline, page 222
5. We acknowledge your response to prior comment 20. With respect to each
milestone in
the "Next Milestone" column, please revise to provide additional
context regarding the
expected timing. For example, we note your disclosure elsewhere that
Orchestra currently
anticipates applying for an IDE and initiating enrollment of the
BackBeat CNT Pivotal
Study in the second half of 2023. Please revise the table to disclose
that Orchestra's
planned application for IDE and the expected initiation of the study
are both expected to
be in the second half of 2023.As another example, please revise to
clarify the process for
the high-risk HTN indication when you state that you will seek to
leverage data. If there
has been no discussion yet regarding the expected trial timing with
the FDA or
comparable foreign regulator, or the ability to leverage other data,
please revise the table
to clearly indicate this information. In addition, please remove the
"Estimated Market"
column from the pipeline table, and to the extent necessary, please
revise the widths of the
columns representing the various trials to provide an accurate
representation of the
duration of the various stages (e.g., if the pivotal trial stage is
expected to be twice as long
as the clinical feasibility stage, please increase the width of the
pivotal trial column
accordingly).
Bioelectronic Product Candidates...
Strategic Collaboration Agreement with Medtronic, page 224
6. We note your response to our previous comment 13 regarding existing
reimbursement
codes. Specifically, you state that based on your discussions with
Orchestra, the terms of
the Medtronic Agreement, and Orchestra's management's knowledge of the
Roderick Wong
Health Sciences Acquisitions Corp 2
October 12, 2022
Page 3
reimbursement codes for medical devices, you believe such increase in
price is possible
without new reimbursement codes. Please expand your discussion to
explain this
rationale. In addition, in the Business section, revise to provide the
basis for Orchestra's
estimates that its addressable annual market is $10 billion.
Preclinical Data, page 228
7. We note your revised disclosures in response to comment 23. However,
please further
revise to explain how the chart "demonstrates the significant
improvement in the entire
24-hour aSBP profile of the animal driven by BackBeat CNT." Also
revise so that the
graphical illustration shows the results of all the study animals,
including the control, or
advise.
8. We refer to the revised lead-in disclosure to the second chart on page
228. You state that
the chart shows "blood pressure levels did not return to higher
baseline levels after
BackBeat CNT was turned off, indicating that sympathetic nervous
system responses were
likely modulated by chronic delivery of BackBeat CNT." Please revise
so that the
statement does not imply an efficacious conclusion, and also explain
how the illustration
shows that blood pressure levels did not return to higher baseline
levels when the green
triangles appear to show a steady increase in systolic pressure as
compared to the red line
representing the use of the BackBeat CNT.
Clinical Results
Acute Clinical Study, page 229
9. We note your response to comment 24 regarding treatment duration
variation for different
patients. Please amend to include what factors the managing physician
considered in their
determination to allow for longer duration.
MODERATO I Single Arm Study, page 229
10. We acknowledge your revised disclosures in response to prior comment
25. You state that
21 patients consented to be followed for a longer study period, and
you disclose the study
results for this longer period for oSBP levels. Please also revise to
state the 24-hour aSBP
levels that were studied during the longer period for the 21 patients,
and if these levels
were not studied for the same period, please revise to explain why.
Similarly, on page 232,
please revise to state the corresponding aSBP results in the MODERATO
II study at 24
months, or explain why aSBP levels were not studied for the same
duration.
11. We refer to your revised disclosures here and elsewhere in response to
prior comment 26.
Please further revise these disclosures to disclose the non-cardiac
related serious adverse
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events, and with respect to the SAEs, explain the number that were
determined to be
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page 57.
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SirolimusEFR - Additional Focal Therapies Product Candidates and Development
Initiatives,
page 249
12. We acknowledge your revised disclosures in response to prior comment
19 and your
statements that you may be able to leverage certain data. Please
revise to clearly explain
that there is no guarantee that you will be able to pursue these
trials at an accelerated pace
or at a reduced cost, and revise your reference in the last paragraph
in this section to being
able to "rapidly advance" these product candidates.
Consolidated Financial Statements of Orchestra Biomed, Inc.
3. Terumo Partnership Agreement, page F-49
13. Please revise to address the following regarding your responses to
prior comments 29 and
31:
In your response to prior comment 29 you indicate that you only
track research and
development expenses related to the Virtue SAB product candidate.
Since you do
track that information, revise your MD&A to quantify the amounts
expensed related
to that product candidate for each period presented.
In your response to prior comment 31 and related revised
disclosures, you indicate
that the amount of revenues recorded for the Terumo Partnership is
based on the
estimated and actual research and development expenses for this
product candidate.
Further, your revised disclosure discusses the significant changes
to both your actual
and estimated future expense which resulted in negative
partnership revenue for
2021. You further disclose that you experienced further material
cost increases during
2022, which led to further changes to your estimates and revenue
recognition pattern.
Accordingly, revise your MD&A and footnotes to quantify the
expenses related to
your Terumo Partnership for each period presented.
Further given their impact on revenues recognized in the
historical periods presented,
disclose the estimated costs to complete the project and quantify
the changes in those
estimates you experienced during the periods presented which led
to the significant
changes in revenues reported.
Revise to confirm, if true, that you update those cost estimates
on a quarterly basis.
You disclose on page F-50 that you experienced "unexpected changes
to regulatory
requirements" that caused you to amend your original project plan.
Revise to more
clearly identify those changes to your regulatory requirements.
Roderick Wong
FirstName LastNameRoderick Wong
Health Sciences Acquisitions Corp 2
Comapany
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2022 Sciences Acquisitions Corp 2
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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,
Division of
Corporation Finance
Office of Industrial
Applications and
Services
cc: Janeane Ferrari, Esq.