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United States securities and exchange commission logo
June 28, 2024
Kristen Fortney, Ph.D.
Chief Executive Officer
BioAge Labs, Inc.
1445A South 50th Street
Richmond, California 94804
Re: BioAge Labs, Inc.
Draft Registration
Statement on Form S-1
Submitted May 31,
2024
CIK No. 0001709941
Dear Kristen Fortney:
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
Overview, page 1
1. We note that
disclosures here, and elsewhere in the prospectus, include statements or
implications that your
product candidates are safe and/or effective. Please revise these
statements, as safety
and efficacy determinations are in the exclusive purview of the FDA
or other regulators.
For example only, the following statements improperly state or imply
that your product
candidates are safe or effective:
On page 1, that
azelaprag "prevented muscle atrophy, preserved muscle quality and
improved
metabolism."
On page 2, that
azelaprag "can recapitulate many of the benefits of exercise."
On page 3, that
azelaprag can "mimic some global effects of exercise at the protein
level."
On page 120, that
azelaprag "significantly prevented [] bed-rest-induced muscle
Kristen Fortney, Ph.D.
FirstName LastNameKristen Fortney, Ph.D.
BioAge Labs, Inc.
Comapany
June NameBioAge Labs, Inc.
28, 2024
June 28,
Page 2 2024 Page 2
FirstName LastName
atrophy[.]"
On page 121, that azelaprag "prevented the decrease in thigh
circumference [], as
well as in muscle diameter and thickness[.]"
2. We note your disclosure here, and on page 3, that in preclinical
obesity models, azelaprag
demonstrated the ability to more than double the weight loss induced
by a glucagon-like-
peptide-1 receptor (GLP-1R) agonist while also restoring healthy body
composition and
improving muscle function. Please provide balancing disclosure with
your statement on
page 20 that results of earlier studies and trials may not be
predictive of future trial results.
Our approach: Targeting human aging biology to treat chronic metabolic
diseases, page 1
3. Please ensure the text of the graphic is legible on page 2.
4. Please specify, if true, that the $150 billion estimate on page 2
refers to a global market, or
otherwise advise.
Our lead product candidate, azelaprag: an orally available, small molecule APJ
agonist..., page 3
5. Please specify the number of volunteers in the Phase 1b clinical
trial.
Our second product candidate, BGE-100, is a novel, orally available,
brain-penetrant inhibitor of
NLRP3, a key target for neuroinflammation, page 6
6. Please provide the basis for the statement that inactivation of NLRP3
in mice has been
shown to significantly extend lifespan, with sustained physical and
cognitive function. In
addition, please quantify the mice tested, or otherwise advise.
Risk Factors
Risks Related to Our Reliance on Third Parties
The manufacture of pharmaceutical products, including our product
candidates..., page 43
7. We note your disclosure that you "currently contract with certain
third-party
manufacturers, which are located in China" and that "since some of
[y]our third-party
manufacturers are located in China, [you] are exposed to the
possibility of product supply
disruption and increased costs in the event of changes in the policies
of the United States
or Chinese governments[.]" We also note your disclosure regarding the
BIOSECURE Act.
Please revise your disclosure to clarify whether any of the
third-party manufacturers that
you currently contract with have been named as "companies of concern"
in the current
U.S. House of Representatives version of the BIOSECURE Act.
Market and Industry Data, page 77
8. We note your statement that investors are cautioned not to give
undue weight to market
estimates and projections. This statement appears to imply a
disclaimer of responsibility
for this information in the registration statement. Please either
revise this section to
remove such implication or specifically state that you are liable for
all information in the
Kristen Fortney, Ph.D.
BioAge Labs, Inc.
June 28, 2024
Page 3
registration statement.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Estimates
Stock-Based Compensation , page 99
9. 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 initial public offering 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.
Our Strategy, page 112
10. Please remove the reference to "[p]otential first- and best-in-class
APJ agonist" in the
graphic as such descriptions imply an expectation of regulatory
approval and are
inappropriate given the length of time and uncertainty with respect to
securing marketing
approval.
Completed clinical trials, page 119
11. Please provide a more fulsome discussion of the seven Phase 1 trials,
including when such
trials occurred, and the specific dosing. In addition, please clearly
disclose the primary
and secondary endpoints, if any, and whether they were achieved.
12. We note your use of p-value on page 120, and elsewhere in the
prospectus. At first use,
please provide a brief explanation of the disclosed p-value and how it
is used to measure
statistical significance.
13. With respect to the Phase 1b clinical trial on page 120, please
clarify whether the three
referenced endpoints were primary or secondary.
Azelaprag for obesity: Genetic evidence supports the potential of azelaprag to
improve
metabolism..., page 125
14. With respect to the genetic studies of apelin in mice, please disclose
whether you
conducted such studies, the number of mice tested, and whether the
observations
were statistically significant.
Preclinical results in a diet-induced obesity model demonstrate the potential
of azelaprag..., page
132
FirstName LastNameKristen Fortney, Ph.D.
Comapany
15. WithNameBioAge
respect to theLabs, Inc. trials, please disclose the number of mice
tested, and
preclinical
whether
June 28, the results
2024 Page 3 were statistically significant.
FirstName LastName
Kristen Fortney, Ph.D.
FirstName LastNameKristen Fortney, Ph.D.
BioAge Labs, Inc.
Comapany
June NameBioAge Labs, Inc.
28, 2024
June 28,
Page 4 2024 Page 4
FirstName LastName
Indication expansion opportunities, page 141
16. We note your disclosure regarding "robust evidence" indicating that
"apelin has the
potential to directly improve insulin sensitivity and glucose control"
and "[r]obust
preclinical evidence" indicating that "apelin signaling may have the
potential to improve
cardiac function in patients with heart failure." In both instances,
please provide further
details about the clinical studies and preclinical work that you
reference in this section,
including, but not limited to, who conducted the studies, what was
observed, and whether
the findings were statistically significant.
Approach for identifying novel targets based on unique insights into human
aging biology, page
144
17. We note you have negotiated favorable agreements with biobanks,
including
SomaLogic and Metabolon, as well as your disclosure on page 2 that you
have exclusive
access to serial biobanked human samples. Please describe the
material terms of the
agreements with each biobank, and file each agreement as an exhibit
pursuant to Item
601(b)(10) of Regulation S-K or explain the basis for your
determination that filing is not
required.
Material Agreements
Exclusive License Agreement with Amgen Inc., page 146
18. Please clarify whether the Series C redeemable convertible preferred
stock held by Amgen
pursuant to the Amgen Agreement will be converted into common stock as
a result of the
offering and, if the Series C shares will be converted, please
disclose the number of shares
of common stock that Amgen will hold.
Intellectual Property
Azelaprag Program, page 149
19. With respect to the in-licensed 10 patent families from Amgen Inc.,
please provide the
patent expiration dates and expected expiration dates on an individual
or family basis for
the non-US pending patent applications. In addition, with respect to
the BGE-
100 Program s seven patent families and the Platform Technology and
Discovery
Program s four patent families, please disclose the patent
expiration dates and expected
expiration dates on an individual or family basis for the pending
patent applications.
20. We note your disclosure on page 150 that you have in-licensed one
patent family from the
Institut National De La Sante Et De La Recherche Medicale (INSERM)
relating to use of
the class of apelin receptor agonists for treating sarcopenia. Please
describe the material
terms of the license agreement, and file the agreement as an exhibit
pursuant to Item
601(b)(10) of Regulation S-K or explain the basis for your
determination that filing is not
required.
Kristen Fortney, Ph.D.
FirstName LastNameKristen Fortney, Ph.D.
BioAge Labs, Inc.
Comapany
June NameBioAge Labs, Inc.
28, 2024
June 28,
Page 5 2024 Page 5
FirstName LastName
General
21. Please provide us with supplemental 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,
have presented or expect to present to potential investors in reliance
on Section 5(d) of the
Securities Act, whether or not you retained, or intend to retain,
copies of the
communications.
Please contact Eric Atallah at 202-551-3663 or Vanessa Robertson at
202-551-3649 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Jimmy McNamara at 202-551-7349 or Joshua Gorsky at 202-551-7836 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Julia Forbess