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United States securities and exchange commission logo
February 4, 2022
Hao-Yuan Chuang
Chief Financial Officer
BELITE BIO, INC
5820 Oberlin Drive, Suite 101
San Diego, CA 92121
Re: BELITE BIO, INC
Amendment No. 1 to
Draft Registration Statement on Form F-1
Submitted January
21, 2022
CIK No. 0001889109
Dear Mr. Chuang:
We have reviewed your amended draft registration statement and
have the following
comments. In some of our comments, we may ask you to provide us with
information so we
may better understand your disclosure.
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 our comments apply 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 these
comments and your
amended draft registration statement or filed registration statement, we
may have additional
comments.
Amendment No. 1 to Draft Registration Statement on Form F-1
Cover Page
1. We note your response
to our prior comment 1 and reissue the comment in part. We also
note that you have
amended your cover page to state that "[a]ll of [y]our operations are
outside of PRC as of
the date of this prospectus." Please revise your disclosure here as
well as elsewhere
throughout the prospectus where you make similar statements such as
on pages 63 and 64 to
clearly state that you have incorporated subsidiaries in China and
Hong Kong.
2. We note your revised
disclosure here as well as similar disclosure elsewhere throughout
the registration
statement, such as on pages 63 and 65, where you state that "in the event
that [you] elect to
carry out clinical trials in China and/or expand [y]our operations into
Hao-Yuan Chuang
FirstName LastNameHao-Yuan Chuang
BELITE BIO, INC
Comapany4,NameBELITE
February 2022 BIO, INC
February
Page 2 4, 2022 Page 2
FirstName LastName
China in the future, there may be certain legal and operational risks
associated with having
certain operations in China [...]." Please revise these statements to
clarify this disclosure
with reference to plans you state elsewhere in the registration
statement such as your plans
to conduct a Phase 3 clinical trial of LBS-008 in patients with STGD1
in Asia as well as
plans for a Phase 2 or 3 clinical trial of LBS-008 for the treatment
of dry AMD in the Asia
Pacific as disclosed on pages 126 and 128, respectively.
3. We note your response to our prior comment 4 as well as your revised
disclosure starting
on the bottom of page 8 where you state that "[a]s of the date of this
prospectus,
[you] have provided US$10.06 million to [y]our subsidiaries via
capital contribution,
including US$0.5 million intercompany loans that have been repaid by
the subsidiary via
the issuance of ordinary shares" and that "[n]o transfer of cash or
other types of assets has
been made between [y]our Cayman Islands holding company and
subsidiaries as of the
date of this prospectus." Please revise your disclosure beginning on
page 8 to clarify what
amounts have been provided to your China-based subsidiary via capital
contribution or
intercompany loans. Please also revise your disclosure here on your
cover page to include
these amounts.
4. We note your response to our prior comment 2 and your response to
comment 1 indicating
that your Chinese subsidiary has not commenced operations. We note
also from your
response that you have been in discussions with the NMPA on how you
shall submit an
application to conduct Phase 3 clinical trials in China. Please
provide prominent
disclosure about the legal and operational risks associated with your
expanding
your operations in China. Your disclosure should make clear whether
these risks could
result in a material change in your operations and/or the value of
your ADSs or could
significantly limit or completely hinder your ability to offer or
continue to offer securities
to investors and cause the value of such securities to significantly
decline or be
worthless. For example, we will not object to disclosure stating that
there is no indication
as to whether NMPA would approve your proposed application or when
such NMPA
approval could be obtained, as referenced in your response.
Additionally, your disclosure
should address how recent statements and regulatory actions by China
s government, such
as those related to the use of variable interest entities and data
security or anti-monopoly
concerns, has or may impact the company s ability to conduct its
business, accept foreign
investments, or list on an U.S. or other foreign exchange. Your
prospectus summary
should address, but not necessarily be limited to, the risks
highlighted on the prospectus
cover page.
Prospectus Summary, page 1
5. We note your response to our prior comment 8 and your response to
comment 1 indicating
that your Chinese subsidiary has not commenced operations. Disclose in
your prospectus
summary each permission that you or your subsidiaries are required to
obtain, or will be
required to obtain if you commence operations, from Chinese
authorities to operate your
business and to offer the ADSs to foreign investors. State whether you
or your subsidiaries
Hao-Yuan Chuang
FirstName LastNameHao-Yuan Chuang
BELITE BIO, INC
Comapany4,NameBELITE
February 2022 BIO, INC
February
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are covered by permissions requirements from the China Securities
Regulatory
Commission (CSRC), Cyberspace Administration of China (CAC) or any
other
governmental agency that is required to approve of you or your
subsidiaries operations,
and state affirmatively whether you have received all requisite
permissions or approvals
and whether any permissions or approvals have been denied. Please also
describe the
consequences to you and your investors if you or your subsidiaries:
(i) do not receive or
maintain such permissions or approvals, (ii) inadvertently conclude
that such permissions
or approvals are not required, or (iii) applicable laws, regulations,
or interpretations
change and you are required to obtain such permissions or approvals in
the future. For
example, we will not object to disclosure stating that there is no
indication as to whether
NMPA would approve your proposed application to conduct Phase 3
clinical trials in
China or when such NMPA approval could be obtained.
LBS-008, page 3
6. We note your response to our prior comment 7 and reissue the comment
in part. We note
that you have revised your disclosure here and on page 115 to state
that "[i]n the US SAD
study, [you] found that single doses of 10 50 mg LBS-008 were well
tolerated and
effective to reduce mean serum RBP4 level by around 70% from
baseline." We also note
that you have revised your disclosure on page 127 to state that "[t]he
DSMC for the Phase
1b portion of the study commented that the overall safety profile
looks
good." Conclusions regarding efficacy and safety are determinations
that only the FDA or
a foreign government equivalent has the authority to make. Please
revise your
disclosure to eliminate the implication that your product candidates
have been or will
ultimately be determined safe and/or effective or have demonstrated
safety and/or efficacy
for purposes of approval by the FDA or comparable agency.
Alternatively, we advise you
that you may present the objective data from pre-clinical and clinical
trials without
drawing a conclusion from the results. For example, you may note that
a candidate was
well tolerated, the absence of serious adverse events or the number of
trial participants
who met the identified trial endpoints.
7. We note your response to prior comment 10. In order for investors to
evaluate your
disclosure, please provide a range or other approximation of the
proportion of revenue you
would be obligated to pay to Columbia University in respect of any
sale of a priority
review voucher.
Summary of Risk Factors, page 7
8. We note your response to our prior comment 13 as well as your response
to comment 1
indicating that your Chinese subsidiary has not commenced operations.
Please provide
risk factor disclosure in the summary risk factors and in the risk
factor section that
discusses the risks of your expanding your operations in China. In
particular, describe in
your summary risk factors any significant regulatory, liquidity, and
enforcement risks with
cross-references to the more detailed discussion of these risks in the
prospectus. For
example, specifically discuss risks arising from the legal system in
China, including risks
Hao-Yuan Chuang
FirstName LastNameHao-Yuan Chuang
BELITE BIO, INC
Comapany4,NameBELITE
February 2022 BIO, INC
February
Page 4 4, 2022 Page 4
FirstName LastName
and uncertainties regarding the enforcement of laws and that rules and
regulations in
China can change quickly with little advance notice; and the risk that
the Chinese
government may intervene or influence your operations at any time, or
may exert more
control over offerings conducted overseas and/or foreign investment in
China-based
issuers, which could result in a material change in your operations
and/or the value of
your ADSs. Acknowledge any risks that any actions by the Chinese
government to exert
more oversight and control over offerings that are conducted overseas
and/or foreign
investment in China-based issuers could significantly limit or
completely hinder your
ability to offer or continue to offer securities to investors and
cause the value of such
securities to significantly decline or be worthless.
Risk Factors
Failure to comply with existing or future laws and regulations related to
privacy or data security
could lead to government enforcement, page 59
9. We note your response to our prior comment 17 as well as your response
to comment 1
indicating that your Chinese subsidiary has not commenced operations.
Please revise your
risk factor disclosure here to discuss the risks of expanding your
operations in China as
those risks relate to privacy or data security. In light of recent
events indicating greater
oversight by the Cyberspace Administration of China over data
security, particularly for
companies seeking to list on a foreign exchange, please revise your
disclosure to explain
how this oversight impacts your business and your offering and to what
extent you believe
that you are compliant with the regulations or policies that have been
issued by the CAC
to date.
Business disruptions could seriously harm our future revenue and financial
condition and
increase our costs and expenses, page 60
10. We note your response to our prior comment 17 and reissue the comment
in part. Please
revise to provide additional detail concerning the risks to your
development plans
highlighted on page 6.
Certain judgments obtained against us by our shareholders may not be
enforceable. , page 77
11. We note your disclosure that some of your directors and
executive officers are nationals
and/or residents of countries other than the U.S. Your disclosure on
page 91 states that
most of your directors and officers are nationals or residents
of jurisdictions other than
the U.S. Please revise to reconcile your disclosure.
The deposit agreement provides that the United States District Court for the
Southern District of
New York , page 79
12. We note your response to our prior comment 32 and we reissue the
comment in part.
Please amend your risk factor disclosure here to also highlight the
risk to shareholders
of increased costs to bring a claim associated with this provision. We
also note that you
Hao-Yuan Chuang
BELITE BIO, INC
February 4, 2022
Page 5
have removed the summary of the exclusive forum provision from your
disclosure on
page 184 of the amended draft registration statement. Please revise your
disclosure in the
section describing your ADSs beginning on page 191 to clearly and
prominently describe
the exclusive forum provision that appears in your deposit agreement,
including the
relevant forum for litigation and any subject matter jurisdiction carve
out. Please disclose
whether this provision applies to actions arising under the Securities
Act or Exchange Act.
If so, please also state that there is uncertainty as to whether a court
would enforce such
provision. If the provision applies to Securities Act claims, please also
state that investors
cannot waive compliance with the federal securities laws and the rules
and regulations
thereunder. In that regard, we note that Section 22 of the Securities Act
creates concurrent
jurisdiction for federal and state courts over all suits brought to
enforce any duty or
liability created by the Securities Act or the rules and regulations
thereunder. If this
provision does not apply to actions arising under the Securities Act or
Exchange Act,
please also ensure that the exclusive forum provision in the governing
documents and
Deposit Agreement states this clearly.
Patent License Agreement with The Trustees of Columbia University in the City
of New York,
page 134
13. We note your response to our prior comment 27 and reissue the comment in
part. Please
expand your disclosure to describe with respect to the royalty term, when
the last-to-
expire patent is anticipated to expire.
Principal Shareholders, page 173
14. We note your response to our prior comment 30 your revised disclosure
here stating that
"[t]he exercise price of the outstanding options granted to the directors
and executive
officers named above are US$0.1191 and US$0.4386 per share." Please
revise your
disclosure throughout the footnotes to the table to specify the exercise
price that
corresponds to the options for each director or executive officer.
You may contact Eric Atallah at 202-551-3663 or Brian Cascio at
202-551-3676 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jessica Ansart at 202-551-4511 or Christine Westbrook at 202-551-5019
with any other
questions.
Sincerely,
FirstName LastNameHao-Yuan Chuang
Division of
Corporation Finance
Comapany NameBELITE BIO, INC
Office of Life
Sciences
February 4, 2022 Page 5
cc: Portia Ku, Esq.
FirstName LastName