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United States securities and exchange commission logo
May 7, 2024
P. Kent Hawryluk
President and Chief Executive Officer
MBX Biosciences, Inc.
11711 N. Meridian Street, Suite 300
Carmel, Indiana 46032
Re: MBX Biosciences,
Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted April 26,
2024
CIK No. 0001776111
Dear P. Kent Hawryluk:
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
April 17, 2024 letter.
Amendment No. 1 to Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1. We note your response
to prior comment 3 and re-issue in part. Please revise the
Overview section of the
Prospectus Summary to clarify that developing drug candidates is
an "uncertain process"
and that you have not yet demonstrated the ability to gain
regulatory approvals.
2. We note your response
to comment 5 and re-issue in part. Please revise your comparison
of the preclinical
results of MBX 4291 and tirzepatide to clarify that MBX 4291 s results
in clinical trials may
not reflect your findings in preclinical studies.
P. Kent Hawryluk
MBX Biosciences, Inc.
May 7, 2024
Page 2
3. We note your response to prior comment 17 and revised disclosure. Please
further revise
your Summary disclosure comparing MBX 4291 and tirzepatide to reflect (i)
your
statements on page 144 indicating that it appears that less frequent
dosing of MBX 4291
would require a higher dose than tirzepatide; (ii) the content of the
graphic on page 144
showing that the concentration of the active component of MBX 4291 was
significantly
lower than the concentration of tirzepatide in the duration comparison;
and (iii) that the
study supporting the potential duration of MBX 4291 was conducted
separately from
studies evaluating its effects.
MBX 2109: Potential best-in-class treatment for chronic hypoparathyroidism,
page 3
4. We note your response to comment 9 and re-issue in part. Please provide
balancing
disclosure when Orphan Drug Designation is first introduced in the
prospectus that it does
not shorten the development time or regulatory review time of a product
candidate and
does not provide any guarantee of approval in the regulatory review or
approval process.
Our company and team, page 6
5. We note your response to comment 8 and re-issue in part. Please revise to
clarify, if
true, Dr. DiMarchi is not an employee of your company. Please also
disclose the number
of hours per week, if any, that Dr. DiMarchi is required to devote to
your company. Please
also revise your disclosure on page 2 to clearly state whether you
currently have any
independent discovery capabilities or whether you are currently reliant
on Dr. DiMarchi's
discovery capabilities.
Business
Our solution: MBX 4291, page 141
6. Please revise your narrative description of the graphic at the top of
page 144 to disclose
the range of concentrations of the (i) active component of MBX 4291 and
(ii) tirzepatide,
respectfully.
Please contact Christine Torney at 202-551-3652 or Angela Connell at
202-551-3426 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Jimmy McNamara at 202-551-7349 or Alan Campbell at 202-551-4224 with
any other
questions.
Sincerely,
FirstName LastNameP. Kent Hawryluk
Division of
Corporation Finance
Comapany NameMBX Biosciences, Inc.
Office of Life
Sciences
May 7, 2024 Page 2
cc: Edwin O Connor
FirstName LastName