View:
United States securities and exchange commission logo
April 17, 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.
Draft Registration
Statement on Form S-1
Submitted March 22,
2024
CIK No. 0001776111
Dear P. Kent Hawryluk:
We have reviewed your
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.
Draft Registration Statement on Form S-1
Cover Page
1. Please disclose, if
accurate, that the closing of this offering is contingent upon a Nasdaq
listing, or otherwise
advise. Please ensure the disclosure is consistent with your
underwriting agreement.
Prospectus Summary
Overview, page 1
2. Please revise your
Prospectus Summary to define or explain briefly scientific or technical
terms. By way of
example, we note the following terms:
Peak-to-trough
Prodrug
Receptor antagonist
Fatty acylation
P. Kent Hawryluk
MBX Biosciences, Inc.
April 17, 2024
Page 2
Hypercalcemic
Hypocalcemic
3. We note your disclosure regarding your pipeline of novel candidates
with "defined
regulatory pathways" and "large market opportunities." Please revise
to reflect your
statements (i) on page 17 that developing product candidates is an
uncertain process , (ii)
on page 16 that you have not yet demonstrated an ability to obtain
regulatory approvals
and (iii) on page 30 that your estimates as to prevalence may not be
accurate and that
published literature includes estimates which are lower than your
estimates.
4. Please remove references throughout your prospectus to potential
"best-in-class" and
first-in-class when describing your product candidates as these
descriptions imply an
expectation of regulatory approval and are inappropriate given the
length of time and
uncertainty with respect to securing such approval. In addition,
please remove claims that
you are able to design and develop novel peptide therapeutics that
have high or enhanced
"potency" and you can improve efficacy and tolerability. Please also
remove any similar
disclosures regarding the current potency or efficacy of your product
candidates as these
statements appear to be premature given your current stage of
development.
5. We note your disclosure here and elsewhere stating that preclinical
studies demonstrated
that MBX 4291 showed a similar efficacy profile as tirzepatide.
As safety and efficacy
determinations are solely within the FDA s authority, please remove
these references to
efficacy. You may compare the performances of MBX 4291 and tirzepatide
in preclinical
studies without concluding as to efficacy. Please also clarify that
MBX 4291's results in
clinical trials may not reflect your findings in preclinical studies.
6. Please revise your Prospectus Summary, where appropriate, to reflect
your disclosure
elsewhere in the prospectus that TransCon PTH was granted a marketing
authorization in
the EU in November 2023 and that you could potentially be precluded
from gaining
approval for MBX 2109 in the EU until 2035. Please also revise to
reflect that an NDA for
TransCon PTH is currently under review by the FDA.
Our Platform, page 2
7. We note that you characterize your PEP platform as "leading" and
"world-class." Please
revise to provide the basis for these statements.
8. We note your disclosure here, and elsewhere, regarding your co-founder
Dr. DiMarchi s
global recognition. Please revise to clarify, if true, Dr. DiMarchi is
not a director or
employee of your company. Please also disclose the number of hours per
week, if any,
FirstName LastNameP. Kent Hawryluk
that Dr. DiMarchi is required to devote to your company. With reference
to your
Comapany NameMBX
disclosure Biosciences,
on page Inc. revise to state whether you have any
independent
22, please also
discovery
April 17, capabilities
2024 Page 2 or whether you are reliant on Dr. DiMarchi's
discovery capabilities.
FirstName LastName
P. Kent Hawryluk
FirstName LastNameP.
MBX Biosciences, Inc. Kent Hawryluk
Comapany
April NameMBX Biosciences, Inc.
17, 2024
April 317, 2024 Page 3
Page
FirstName LastName
MBX 2109: Potential best-in-class treatment for chronic hypoparathyroidism,
page 3
9. We note your disclosure on page 4 that the FDA has granted Orphan Drug
Designation to
MBX 2109 for the treatment of HP. Please briefly describe the
significance of having
obtained orphan drug designation. In addition, please revise your
reference to orphan drug
designation to clarify that such a designation neither shortens the
development time or
regulatory review time of a product candidate, nor does it provide any
guarantee of
approval in the regulatory review or approval process.
Our Pipeline, page 3
10. We note your inclusion of a row in your pipeline table for "Additional
Obesity Programs."
However, none of these programs appear to be discussed in your
prospectus. Accordingly,
please remove this row from your pipeline table.
Our company and team, page 6
11. We note your disclosure regarding raising funding from leading
healthcare investors.
Please clarify that prospective investors should not rely on the named
investors
investment decisions, that these investors may have different risk
tolerances and, if true,
that the shares purchased by these investors were acquired at a
discount to the IPO price.
Our Strategy, page 7
12. We note your disclosure here, and elsewhere, regarding your strategy
to rapidly advance
MBX 2109 and MBX 1416 through clinical development. Please revise
these statements
and any other similar statements to remove any implication that you
will be successful in
advancing your product candidates in a rapid or accelerated manner, as
such statements
are speculative. In this regard, we note your disclosure on page 17
that developing product
candidates, including conducting preclinical studies and clinical
trials, is a very time-
consuming, expensive and uncertain process that takes years to
complete.
Critical Accounting Policies and Significant Judgments and Estimates
Determination of the Fair Value of Common Stock, page 114
13. Please revise disclosures to explain the specific event(s) or
factor(s) that resulted in an
increase in the initial valuation of the common stock fair value from
$0.27 per share to
$0.34 per share.
14. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the common stock underlying your equity
issuances and the
reasons for any differences between the recent valuations of your
common stock leading
up to the IPO and the estimated offering price. This information will
help facilitate our
review of your accounting for equity issuances including stock
compensation. Please
discuss with the staff how to submit your response.
P. Kent Hawryluk
FirstName LastNameP.
MBX Biosciences, Inc. Kent Hawryluk
Comapany
April NameMBX Biosciences, Inc.
17, 2024
April 417, 2024 Page 4
Page
FirstName LastName
Business
Ongoing Avail Phase 2 clinical trial, page 134
15. Please revise this section to reflect your disclosure on pages 29-30
indicating that you
have added new sites to this trial following slow enrollment at the
originally selected sites
and that you were unable to enroll sites in the EU.
Our solution: MBX 4291
Preclinical studies, page 141
16. Please define CPS in the graphic on page 141.
17. Please revise to clarify the number of mice dosed with the MBX 4291
active drug and
tirzepatide, as well as the number of non-human primates used to
assess the conversion of
MBX 4191. We also note your claims here and throughout the prospectus
indicating that
MBX 4291 demonstrated extended duration as compared to tirzepatide in
a preclinical
study that may support once-monthly dosing. However, the preclinical
study on page 142
appears to indicate that observation of the concentration of
tirzepatide ceased after one
week. In addition, it appears that you are relying on the results of
MBX 4291 active drug
to support your claim that the decline in exposure is flatter than the
more rapid reduction
in tirzepatide exposure. However, your disclosure elsewhere in the
prospectus indicates
that you are developing MBX 4291 as a prodrug and the prodrug decline
in exposure
appears to track tirzepatide's. Please advise and revise your
disclosure accordingly. To the
extent observation of tirzepatide ceased after one week, please remove
or revise your
claims that MBX 4291 has demonstrated an extended duration as compared
to tirzepatide.
License agreement
Indiana University Research and Technology Corporation Exclusive License
Agreement, page
145
18. Please revise to provide the percentage of the sublicensing revenue,
or a range not
exceeding 10 percentage points.
Exhibits
19. Please revise to either (i) clearly disclose that Exhibit 10.6 also
contains amendments to
the original agreement or (ii) separately number the amendments to the
license agreement.
20. When available, please file the Senior Executive Cash Incentive Bonus
Plan as an exhibit
to your registration statement.
General
21. Please ensure the writing is legible in the visual depictions
throughout your draft
registration statement. For example only, certain text on the y-axis
on pages 127 and 133
is not legible.
P. Kent Hawryluk
MBX Biosciences, Inc.
April 17, 2024
Page 5
22. Please supplementally provide us with copies of all written
communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do
so on your behalf,
present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
not they retain copies of the communications.
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
April 17, 2024 Page 5
cc: Edwin O Connor
FirstName LastName