SEC Comment Letter 0000000000-22-013214 to Orchestra BioMed Holdings, Inc. (OBIO) (CIK 0001814114) (OBIO)
Orchestra BioMed Holdings, Inc. (OBIO) (CIK 0001814114)
Date: Dec. 7, 2022 · CIK: 0001814114 · Accession: 0000000000-22-013214
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File numbers found in text: 333-266660
Letter
United States securities and exchange commission logo December 7, 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. 3 to Registration Statement on Form S-4 Filed November 22, 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 November 9, 2022 letter. Amendment No. 3 to Registration Statement on Form S-4 Business of Orchestra Advancing a High-Impact Pipeline, page 224 1.We note your response to our previous comment 4 regarding next milestones and expected timing. Please revise to clearly state in the table or the footnotes whether an IDE or CTN has already been submitted for these trials or if they have not yet been submitted to give potential investors a better understanding of the timeline presented. Business of Orchestra Clinical Results, page 247 2.We refer to your revised disclosure on page 248 that eight SAEs out of 29 SAEs were
FirstName LastNameRoderick Wong Comapany NameHealth Sciences Acquisitions Corp 2 December 7, 2022 Page 2 FirstName LastName Roderick Wong Health Sciences Acquisitions Corp 2 December 7, 2022 Page 2 "adjudicated as 'highly probable', 'probable', or 'unlikely' related to the index procedure and/or the investigational device." Please revise to clearly explain the number of SAEs that are related to the procedure or device, and if these were all cardiac-related. You may separately disclose the number of SAEs that are "unlikely" to be related to the procedure or device. 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.
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United States securities and exchange commission logo
December 7, 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. 3 to Registration Statement on Form S-4
Filed November 22, 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 November 9, 2022 letter.
Amendment No. 3 to Registration Statement on Form S-4
Business of Orchestra
Advancing a High-Impact Pipeline, page 224
1.We note your response to our previous comment 4 regarding next milestones and expected
timing. Please revise to clearly state in the table or the footnotes whether an IDE or CTN
has already been submitted for these trials or if they have not yet been submitted to give
potential investors a better understanding of the timeline presented.
Business of Orchestra
Clinical Results, page 247
2.We refer to your revised disclosure on page 248 that eight SAEs out of 29 SAEs were
FirstName LastNameRoderick Wong
Comapany NameHealth Sciences Acquisitions Corp 2
December 7, 2022 Page 2
FirstName LastName
Roderick Wong
Health Sciences Acquisitions Corp 2
December 7, 2022
Page 2
"adjudicated as 'highly probable', 'probable', or 'unlikely' related to the index procedure
and/or the investigational device." Please revise to clearly explain the number
of SAEs that are related to the procedure or device, and if these were all cardiac-related.
You may separately disclose the number of SAEs that are "unlikely" to be related to the
procedure or device.
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.