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United States securities and exchange commission logo
December 30, 2021
Yu-Hsin Lin
Chief Executive Officer
BELITE BIO, INC
5820 Oberlin Drive, Suite 101
San Diego, CA 92121
Re: BELITE BIO, INC
Draft Registration
Statement on Form F-1
Submitted December
1, 2021
CIK No. 0001889109
Dear Dr. Lin:
We have reviewed your 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.
Draft Registration Statement on Form F-1
Cover Page
1. Please disclose
prominently on the prospectus cover page that you are not a Chinese
operating company but a
Cayman Islands holding company with operations conducted by
your subsidiaries,
including by your Chinese subsidiary.
2. Provide prominent
disclosure about the legal and operational risks associated with the
company s 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. Your
disclosure should address how recent statements and regulatory actions
Yu-Hsin Lin
FirstName LastNameYu-Hsin Lin
BELITE BIO, INC
Comapany30,
December NameBELITE
2021 BIO, INC
December
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FirstName LastName
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. Please disclose whether your auditor is subject to the
determinations
announced by the PCAOB on December 16, 2021 and whether and how the
Holding
Foreign Companies Accountable Act and related regulations will affect
your company.
Your prospectus summary should address, but not necessarily be limited
to, the risks
highlighted on the prospectus cover page.
3. Clearly disclose how you will refer to the holding company and
subsidiaries when
providing the disclosure throughout the document so that it is clear
to investors which
entity the disclosure is referencing and which subsidiaries or
entities are conducting the
business operations. For example, disclose, if true, that your
subsidiaries conduct
operations in China and that the holding company does not conduct
operations. Disclose
clearly the entity (including the domicile) in which investors are
purchasing their interest.
4. Provide a description of how cash is transferred through your
organization. State whether
any transfers, dividends, or distributions have been made to date
between the holding
company and its subsidiaries, or to investors, and quantify the
amounts where applicable.
5. We note your disclosure on page 80 that you are a controlled company
under the Nasdaq
Stock Market Rules. If you intend to qualify as a controlled company
after the offering,
please provide related disclosure on the cover page.
Overview, page 1
6. We note your disclosure here that your lead product candidate,
LBS-008, was developed
from your RBP4 platform technology. Please expand your disclosure in
the prospectus
summary as well as in the business section to describe the key aspects
of this platform
technology and how it is used to develop your product candidates.
7. We note your disclosure here and in the business section in which you
make statements
related to potential safety and efficacy, which are premature given
the stage of
development of the company's product candidates. For example:
LBS-008 is a treatment "that can reduce and maintain the
delivery of vitamin A
(retinol) to the eye in a safe and effective manner";
LBS-008 has demonstrated its "safety, potency and consistency
that we believe is
clinically meaningful to treat STGD1 patients";
LBS-008 can "achieve mean RBP4 level reduction of > 70% without
observing any
significant side-effects";
LBS-008 is "expected to have a positive treatment effect in a
significant portion of
this population of dry AMD patients";
LBS-008 has a "proven mechanism of action";
LBS-008 treatment "is effective to reduce serum RBP4 by > 70%";
and
All dose levels of LBS-008 in the Phase 1 Clinical Trial in Dry
AMD "were
Yu-Hsin Lin
FirstName LastNameYu-Hsin Lin
BELITE BIO, INC
Comapany30,
December NameBELITE
2021 BIO, INC
December
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FirstName LastName
determined to be safe and well tolerated."
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 throughout your document, including but not limited to the
statements noted
above, 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.
Prospectus Summary, page 1
8. Disclose in your prospectus summary each permission that you or your
subsidiaries are
required to obtain from Chinese authorities to operate your business
and to offer the ADSs
to foreign investors. State whether you or your subsidiaries 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.
9. Provide a clear description of how cash is transferred through your
organization in your
prospectus summary. Quantify any cash flows and transfers of other
assets by type that
have occurred between the holding company and its subsidiaries, and
direction of
transfer. Quantify any dividends or distributions that a subsidiary
has made to the holding
company, which entity made such transfer, and their tax consequences.
Similarly quantify
dividends or distributions made to U.S. investors, the source, and
their tax
consequences. Your disclosure should make clear if no transfers,
dividends or
distributions have been made to date. Describe any restrictions on
foreign exchange and
your ability to transfer cash between entities, across borders, and to
U.S. investors.
Describe any restrictions and limitations on your ability to
distribute earnings from the
company, including your subsidiaries, to the parent company and U.S.
investors.
10. Your summary should provide a balanced and factual presentation of
your business.
Please balance your disclosure with reference to competition from
product candidates in
development to treat the same indications as LBS-008, as referenced on
pages 24 and 127.
Additionally, please expand your disclosure on page 2 to disclose the
portion of proceeds
from any sale of a priority review voucher you are obligated to pay to
Columbia
Yu-Hsin Lin
FirstName LastNameYu-Hsin Lin
BELITE BIO, INC
Comapany30,
December NameBELITE
2021 BIO, INC
December
Page 4 30, 2021 Page 4
FirstName LastName
University under your license agreement, as referenced on page 126.
Please make
corresponding revisions to your disclosure concerning the license
agreement in the
business section.
Our Strategies, page 5
11. We note your reference to rapidly advancing the development of
LBS-008 through
clinical trials and regulatory approval. Please revise this statement
here and throughout
your prospectus to remove any implication that you will be successful
in developing and
receiving approval for your product candidate in a rapid or
accelerated manner
Our Strengths , page 5
12. Your statement that two of your strengths include a "first-in-class
oral therapy" and a
"proven mechanism of action" implies the likelihood of regulatory
approval and
comparisons to other product candidates. Please remove the
"first-in-class" and
"proven" references here and throughout the prospectus as appropriate
as the statements
are speculative in light of the regulatory status of the product
candidates you are currently
pursuing.
Summary of Risk Factors, page 6
13. In your summary of risk factors, disclose the risks that your
corporate structure and the
company s operations in China poses to investors. In particular,
describe the 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 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.
Additionally, please organize your summary risk factors and your risk
factor section so
that risks related to doing business in China appear first.
14. Please add a bullet point highlighting the risks associated with the
concentration of
ownership by your principal shareholder, as referenced on page 70.
Implications of Being an Emerging Growth Company, page 7
15. We note your disclosure that you have elected to take advantage of the
benefits of the
extended transition period for complying with new or revised
accounting standards under
Yu-Hsin Lin
FirstName LastNameYu-Hsin Lin
BELITE BIO, INC
Comapany30,
December NameBELITE
2021 BIO, INC
December
Page 5 30, 2021 Page 5
FirstName LastName
Section 102(b)(1). Please also include risk factor disclosure
explaining that the election
allows for the delay of the adoption of new or revised accounting
standards that have
different effective dates for public and private companies until those
standards apply to
private companies and that as a result of this election, your
financial statements may not
be comparable to companies that comply with public company effective
dates with similar
disclosure.
Risk Factors
Risks Related to Our Industry, Business and Operations
Our internal computer systems, or those used by our CROs or other contractors
or consultants,
may fail or suffer security breaches, page 56
16. We note your disclosure here that "[you] have on occasion experienced,
and will continue
to experience, threats to [y]our data and systems." To the extent you
have been materially
impacted by a cybersecurity breach, please include a description of
the incident, costs, and
other consequences. For additional guidance, please refer to CF
Disclosure Guidance
Topic No. 2 on Cybersecurity.
Failure to comply with existing or future laws and regulations related to
privacy or data security
could lead to government enforcement, page 57
17. We note your disclosure here that makes reference to the Cyberspace
Administration of
China and its various rules and regulations with respect to 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..., page 58
18. We note your disclosure that you have experienced delays in the
enrollment of patients in
your clinical trials due to COVID-19. Please revise to provide
additional detail concerning
the impact of COVID-19 on your clinical trial enrollment and risks to
your development
plans highlighted on page 5.
Risks Related to Doing Business in China, page 64
19. We note from the audit opinion that you have a U.S. based auditor that
is registered with
the PCAOB and subject to PCAOB inspection. Please disclose any
material risks to the
company and investors if it is later determined that the PCAOB is
unable to inspect or
investigate completely your auditor because of a position taken by an
authority in a
foreign jurisdiction. For example, disclose the risk that lack of
inspection could cause
trading in your securities to be prohibited under the Holding Foreign
Companies
Accountable Act and as a result an exchange may determine to delist
your securities.
Yu-Hsin Lin
FirstName LastNameYu-Hsin Lin
BELITE BIO, INC
Comapany30,
December NameBELITE
2021 BIO, INC
December
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20. Please expand your risk factors to disclose that the United States
Senate has passed the
Accelerating Holding Foreign Companies Accountable Act, which, if
enacted, would
decrease the number of non-inspection years from three years to
two years, and thus,
would reduce the time before your securities may be prohibited from
trading or delisted.
Update your disclosure to reflect that the Commission adopted rules to
implement the
HFCAA and that, pursuant to the HFCAA, the PCAOB has issued its report
notifying the
Commission of its determination that it is unable to inspect or
investigate completely
accounting firms headquartered in mainland China or Hong Kong.
21. We note your disclosure in a risk factor on page 57 concerning risks
related to your
compliance with data security laws that makes reference to the
Cyberspace Administration
of China and its various rules and regulations. 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.
Use of Proceeds, page 84
22. Please revise this section to provide more specific detail regarding
the use of the funds to
be allocated to the clinical development of LBS-008 for the treatment
of STGD1 and for
dry AMD, respectively, including reference to how far into the
development processes the
proceeds will enable you to reach, as applicable.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations , page 100
23. We note that you did not provide a discussion of your results of
operations for the year
ended December 31, 2020. Please revise your filing to discuss the
significant components
of your operating expenses for the year ended December 31, 2020. Refer
to Item 5 of
Form 20-F.
Critical Accounting Policies and Estimates
Share-Based Compensation, page 107
24. 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
and beneficial conversion features. Please discuss with the staff how
to submit your
response.
Yu-Hsin Lin
FirstName LastNameYu-Hsin Lin
BELITE BIO, INC
Comapany30,
December NameBELITE
2021 BIO, INC
December
Page 7 30, 2021 Page 7
FirstName LastName
Business
Clinical Development, page 120
25. To the extent not disclosed, please revise your discussion of the
preclinical and clinical
trials for each of your product candidates conducted to date to
specify the primary and
secondary endpoints of the different trials, the results as they
relate to the endpoints and
any statistical analysis that was done. Also add an explanation of how
statistical
significance relates to the approval process of the FDA and other
regulators.
Patents, page 124
26. Please revise to disclose for each material patent and patent
application the specific
products to which such patents or patent applications relate, whether
the patents are
owned or licensed, the type of patent protection, the expiration
dates, and applicable
material jurisdictions, including any foreign jurisdiction. Consider
disclosure in tabular
format by patent family or otherwise in addition to the narrative
provided. We also note
your disclosure on page 40 that "[y]our licensed and co-owned patents
and pending patent
applications have been generated through the use of U.S. government
funding," which
could subject you to "march-in rights." Please identify here any
patents or pending patent
applications that are or would be subject to march-in rights.
Patent License Agreement with The Trustees of Columbia University in the City
of New York,
page 125
27. We note your disclosure on page 135 outlining your license agreement
with The Trustees
of Columbia University. Please expand your disclosure to describe all
material terms of
the agreement including:
quantification of the upfront license issue fee previously paid;
quantification of the minimum annual royalty; and
with respect to the royalty term, when the last-to-expire patent
is anticipated to
expire.
Facilities, page 127
28. We note your disclosure in a risk factor on page 54 that you have
facilities in California,
Australia, Taiwan and China, however, here you only provide
information for facilities in
California, Taiwan and China. Please clarify whether you also have
facilities in Australia
and revise your disclosure to reflect information concerning any such
facility.
Management
Share Incentive Plans, page 166
29. We note your disclosure here describing your 2020 Share Incentive Plan
as well as your
2021 Performance Incentive Plan, which you plan to adopt in connection
with this
offering. Additionally, we note you intend to file as Exhibit 10.1 the
Belite Bio, Inc.
Amended and Restated Share Option Plan. Please clarify whether this
exhibit relates to
Yu-Hsin Lin
FirstName LastNameYu-Hsin Lin
BELITE BIO, INC
Comapany30,
December NameBELITE
2021 BIO, INC
December
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the 2020 Share Incentive Plan or to the 2021 Performance Incentive
Plan. Furthermore,
please ensure that both incentive plans are filed as exhibits or
advise us why such
agreement is not required to be filed. Refer to Item 601(b)(10) of
Regulation S-K.
Principal Shareholders, page 168
30. Please revise the information here regarding options to include the
exercise price and the
purchase price, if any, of the options. Refer to Item 6.E. of Form
20-F.
Related Party Transactions
2021 LBS-008 R&D Services Agreement, page 172
31. We note your disclosure here describing the terms of your current R&D
services
agreement with your ultimate controlling shareholder, Lin Bioscience,
Inc. Please file this
agreement as an exhibit or advise us why this agreement is not
required to be filed. Refer
to Item 601(b)(10) of Regulation S-K.
Description of Share Capital
Exclusive Forum, page 179
32. We note your disclosure that indicates that the deposit agreement
provides that the U.S.
District Court for the Southern District of New York shall be the
exclusive forum for the
resolution of any complaint asserting a cause of action arising under
the Securities Act
and the Exchange Act. Please include a risk factor that highlights the
risks associated with
this provision and other impacts on shareholders, which may include
increased costs to
bring a claim and that these provisions may discourage claims or limit
shareholders'
ability to bring a claim in a judicial forum that they find favorable.
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. Address in your risk factor disclosure that
there is uncertainty as to
whether a court would enforce such provision.
General
33. 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.
Yu-Hsin Lin
BELITE BIO, INC
December 30, 2021
Page 9
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 LastNameYu-Hsin Lin
Division of
Corporation Finance
Comapany NameBELITE BIO, INC
Office of Life
Sciences
December 30, 2021 Page 9
cc: Portia Ku, Esq.
FirstName LastName