Correspondence 0001193125-24-206234 from MBX Biosciences, Inc. (MBX)
MBX Biosciences, Inc.
Date: Aug. 23, 2024 · CIK: 0001776111 · Accession: 0001193125-24-206234
AI Filing Summary & Sentiment
Reasoning
Referenced dates: July 22, 2024
Letter
VIA EDGAR AND FEDERAL EXPRESS United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences Attention: Christine Torney, Angela Connell, Jimmy McNamara, Alan Campbell Re: MBX Biosciences, Inc. Amendment No. 2 to Draft Registration Statement on Form S-1 Submitted July 11, 2024 CIK 0001776111
Dear Ladies and Gentlemen:
This letter is submitted on behalf of MBX Biosciences, Inc. (the “Company”), in response to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the Company’s Draft Registration Statement on Form S-1, originally confidentially submitted on March 22, 2024 (the “Draft Registration Statement”), and resubmitted on April 26, 2024 ( “Amendment No. 1 to the Draft Registration Statement”) and July 11, 2024 (“Amendment No. 2 to the Draft Registration Statement”), as set forth in the Staff’s letter, dated July 22, 2024, addressed to P. Kent Hawryluk (the “Comment Letter”). The Company is concurrently publicly filing the Registration Statement on Form S-1 (the “Registration Statement”), which includes changes to reflect the response to the Staff’s comment and other updates.
For reference purposes, the text of the Comment Letter has been reproduced herein with responses below each numbered comment. For your convenience, we have italicized the reproduced Staff comments from the Comment Letter. Unless otherwise indicated, page references in the descriptions of the Staff’s comments refer to Amendment No. 2 to the Draft Registration Statement, and page references in the responses refer to the Registration Statement. All capitalized terms used and not otherwise defined herein shall have the meanings set forth in the Registration Statement.
Amendment No. 2 to Draft Registration Statement on Form S-1
Business
Phase 1 clinical development and results, page 135
1. We note your discussion of the results of your Phase 1 trial of MBX 2109 and the separate Phase 1 trial of TransCon PTH. Please revise your disclosure to briefly describe the limitations of cross-study comparisons as opposed to head-to-head comparisons.
RESPONSE: The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosure on page 136 of the Registration Statement in response to the Staff’s comment.
If you should have any questions concerning the enclosed matters, please contact the undersigned at (212) 813-8853.
Sincerely,
/s/ Edwin M. O’Connor
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CORRESP 1 filename1.htm CORRESP Goodwin Procter LLP 100 Northern Avenue Boston, MA 02210 goodwinlaw.com +1 617 570 1000 August 23, 2024 VIA EDGAR AND FEDERAL EXPRESS United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F. Street, N.E. Washington, D.C. 20549 Attention: Christine Torney, Angela Connell, Jimmy McNamara, Alan Campbell Re: MBX Biosciences, Inc. Amendment No. 2 to Draft Registration Statement on Form S-1 Submitted July 11, 2024 CIK 0001776111 Dear Ladies and Gentlemen: This letter is submitted on behalf of MBX Biosciences, Inc. (the “Company”), in response to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the Company’s Draft Registration Statement on Form S-1, originally confidentially submitted on March 22, 2024 (the “Draft Registration Statement”), and resubmitted on April 26, 2024 ( “Amendment No. 1 to the Draft Registration Statement”) and July 11, 2024 (“Amendment No. 2 to the Draft Registration Statement”), as set forth in the Staff’s letter, dated July 22, 2024, addressed to P. Kent Hawryluk (the “Comment Letter”). The Company is concurrently publicly filing the Registration Statement on Form S-1 (the “Registration Statement”), which includes changes to reflect the response to the Staff’s comment and other updates. For reference purposes, the text of the Comment Letter has been reproduced herein with responses below each numbered comment. For your convenience, we have italicized the reproduced Staff comments from the Comment Letter. Unless otherwise indicated, page references in the descriptions of the Staff’s comments refer to Amendment No. 2 to the Draft Registration Statement, and page references in the responses refer to the Registration Statement. All capitalized terms used and not otherwise defined herein shall have the meanings set forth in the Registration Statement. Amendment No. 2 to Draft Registration Statement on Form S-1 Business Phase 1 clinical development and results, page 135 1. We note your discussion of the results of your Phase 1 trial of MBX 2109 and the separate Phase 1 trial of TransCon PTH. Please revise your disclosure to briefly describe the limitations of cross-study comparisons as opposed to head-to-head comparisons. RESPONSE: The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the disclosure on page 136 of the Registration Statement in response to the Staff’s comment. If you should have any questions concerning the enclosed matters, please contact the undersigned at (212) 813-8853. Sincerely, /s/ Edwin M. O’Connor Edwin M. O’Connor, Esq. Enclosures cc: P. Kent Hawryluk, MBX Biosciences, Inc. Richard Bartram, MBX Biosciences, Inc. Mitchell S. Bloom, Esq., Goodwin Procter LLP Daniel Hughes, Esq., Goodwin Procter LLP