SEC Comment Letter 0000000000-24-013615 to Sionna Therapeutics, Inc. (SION) (CIK 0002036042) (SION)
Sionna Therapeutics, Inc. (SION) (CIK 0002036042)
Date: Dec. 10, 2024 · CIK: 0002036042 · Accession: 0000000000-24-013615
AI Filing Summary & Sentiment
Letter
December 10, 2024 Michael Cloonan President and Chief Executive Officer Sionna Therapeutics, Inc. 21 Hickory Drive, Suite 500 Waltham, MA 02451 Re:Sionna Therapeutics, Inc. Amendment No. 1 to Draft Registration Statement on Form S-1 Submitted November 26, 2024 CIK No. 0002036042 Dear Michael Cloonan: We have reviewed your amended draft registration statement and have the following comments. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe a comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to this letter and your amended draft registration statement or filed registration statement, we may have additional comments. Unless we note otherwise, any references to prior comments are to comments in our October 10, 2024 letter. Amendment No. 1 to Draft Registration Statement on Form S-1 submitted November 26, Risk Factors We contract with third parties for the manufacture of our product candidates for clinical drug supply..., page 36 We note your response to prior comment 13. Please revise your risk factor to disclose the single services agreement with WuXi AppTec (HongKong) Limited, as WuXi is a Chinese biotechnology company of concern named in the BIOSECURE Act, which could impact the availability of U.S. government contracts, grants, and loans. Please also revise your statement that the company has "in the past relied" on foreign 1.
December 10, 2024 Page 2 CDMOs in China. General 2.We note that you have removed all disclosure related to SION-638 from the prospectus. We also note a press release dated January 3, 2024, which described SION-638 as your "lead candidate". In your response letter, please explain the removal of the disclosure regarding this product candidate and whether the company has discontinued its development. Please contact Jenn Do at 202-551-3743 or Angela Connell at 202-551-3426 if you have questions regarding comments on the financial statements and related matters. Please contact Tamika Sheppard at 202-551-8346 or Laura Crotty at 202-551-7614 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc:Gabriela Morales-Rivera
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December 10, 2024
Michael Cloonan
President and Chief Executive Officer
Sionna Therapeutics, Inc.
21 Hickory Drive, Suite 500
Waltham, MA 02451
Re:Sionna Therapeutics, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted November 26, 2024
CIK No. 0002036042
Dear Michael Cloonan:
We have reviewed your amended draft registration statement and have the following
comments.
Please respond to this letter by providing the requested information and either
submitting an amended draft registration statement or publicly filing your registration
statement on EDGAR. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing the information you provide in response to this letter and your
amended draft registration statement or filed registration statement, we may have additional
comments. Unless we note otherwise, any references to prior comments are to comments in
our October 10, 2024 letter.
Amendment No. 1 to Draft Registration Statement on Form S-1 submitted November 26,
2024
Risk Factors
We contract with third parties for the manufacture of our product candidates for clinical drug
supply..., page 36
We note your response to prior comment 13. Please revise your risk factor to disclose
the single services agreement with WuXi AppTec (HongKong) Limited, as WuXi is a
Chinese biotechnology company of concern named in the BIOSECURE Act, which
could impact the availability of U.S. government contracts, grants, and loans. Please
also revise your statement that the company has "in the past relied" on foreign 1.
December 10, 2024
Page 2
CDMOs in China.
General
2.We note that you have removed all disclosure related to SION-638 from the
prospectus. We also note a press release dated January 3, 2024, which
described SION-638 as your "lead candidate". In your response letter, please explain
the removal of the disclosure regarding this product candidate and whether the
company has discontinued its development.
Please contact Jenn Do at 202-551-3743 or Angela Connell at 202-551-3426 if you
have questions regarding comments on the financial statements and related matters. Please
contact Tamika Sheppard at 202-551-8346 or Laura Crotty at 202-551-7614 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Gabriela Morales-Rivera