United States securities and exchange commission logo





                              August 19, 2021

       Yizhe Wang, Ph.D.
       Chief Executive Officer
       LianBio
       103 Carnegie Center Drive, Suite 215
       Princeton, NJ 08540

                                                        Re: LianBio
                                                            Amendment No. 1 to
                                                            Draft Registration
Statement on Form S-1
                                                            Submitted August 9,
2021
                                                            CIK No. 0001831283

       Dear Dr. Wang:

             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 S-1

       Cover Page

   1.                                                   Provide prominent
disclosure about the legal and operational risks associated with being
                                                        based in or having the
majority of the company   s operations in China and Hong Kong.
                                                        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 by China   s government, such as those
                                                        related to the use of
variable interest entities and data security or anti-monopoly concerns,
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         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.
2.       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. Disclose clearly the entity (including the
domicile) in which
         investors are purchasing their interest.
3.       Provide prominent disclosure about the legal and operational risks
associated with being
         based in or having the majority of the company   s operations in China
and Hong Kong.
         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 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

4.       Disclose each permission that you or your subsidiaries are required to
obtain from Chinese
         authorities to operate and issue these securities to foreign
investors. State whether you or
         your subsidiaries are covered by permissions requirements from the
CSRC, CAC or any
         other entity that is required to approve of you or your subsidiaries
 operations, and state
         affirmatively whether you have received all requisite permissions and
whether any
         permissions have been denied.
5.       Provide a clear description of how cash is transferred through your
organization. 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 and
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.
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 your businesses, including subsidiaries, to the parent
company and U.S.
         investors.
Our Pipeline, page 2
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6.       We note your response to our prior comment number 2, which we reissue
in part.
         Specifically with respect to your pipeline table at pages 2 and 122,
please revise to ensure
         that all text is large enough to be easily legible.
7.       We note the revisions to your pipeline table in response to prior
comment 3. In this regard,
         please address the following:

                We note you have added disclosure in the    Next Step in China
  column of the
              pipeline table regarding the Company   s plans to    join BMS
future global Phase 3
              trials    for mavacamten in the treatment of nHCM and HFpEF.
However, we note
              that narrative disclosure on pages 3, 125, 130, and 134-135,
which generally indicates
              that the Company intends to develop mavacamten in its licensed
territories for these
              indications, does not describe the Company   s intentions or
goals with respect to
              joining these development programs in any detail. To add context
supporting your
              pipeline table, please revise your narrative disclosures
throughout the registration
              statement to address how the Company plans to pursue the
development of
              mavacamten for the treatment of nHCM and HFpEF, including its
intended
              involvement in future BMS global Phase 3 trials.
                We note that you appear to have indicated    N/A    in the
Next Step in China    column
              of the pipeline table for NBTXR3 for the treatment of soft tissue
sarcoma (STS). We
              also note disclosure on page 125 and 139 generally indicating
that you plan to join
              the NBTXR3 development program by enrolling patients in China in
certain of
              Nanobiotix   s potential future global pivotal trials, beginning
with Nanobiotix   s
              announced planned Phase 3 NANORAY-312 clinical trial in locally
advanced head
              and neck cancer. However, it is not clear from these disclosures
whether your
              participation in the NBTXR3 development program involves the STS
indication. If
              the Company will not be involved in the further development or
commercialization of
              NBTXR3 for STS in its licensed jurisdictions, it would appear
that this program is
              not sufficiently material to your operations to warrant inclusion
in the pipeline table.
              Please explain why you believe it is appropriate to include
NBTXR3 for STS in the
              pipeline table, making clarifying revisions to your narrative
disclosures throughout
              the registration statement as appropriate, or remove.
                In Footnote 2 to the pipeline table, and elsewhere in the
registration statement, please
              remove the reference to NBTXR3   s CE Mark approval    allowing
for
              commercialization in 27 countries,    as these countries are not
in the Company   s
              licensed territory. Instead, similar to your disclosures on pages
3 and 123, please
              simply state that NBTXR3 has received CE mark approval in the
European Union,
              which is not in your licensed territory, for the treatment of
locally advanced
              STS. Additionally, for consistency, on page 123 and in certain
other places
              throughout your registration statement, please add disclosure
indicating where
              approvals in certain jurisdictions are not in your licensed
territories for your product
              candidates.
                We acknowledge your response to prior comment 4. We now note
that you have not
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              disclosed anything in the    Next Step in China    column of the
pipeline table for
              infigratinib for second-line CCA, and that the arrow shows that
the product is
                 approved    for this indication. While we note footnote 3
stating that infigratinib   s
              approval in the United States is not within your licensed
territory, the visual depiction
              in combination with the lack of disclosure regarding next steps
may be misleading
              and imply that the Company has no further steps left to take to
commercialize
              infigratinib in China. We note your revised disclosure on pages
126, 144 and 146
              indicating that you    intend to pursue commercialization and
registration strategies in
              [your] territories for infigratinib    in second-line CCA. Please
revise these
              disclosures, as well as infigratinib disclosures in your
prospectus summary and
              pipeline table, to provide more context regarding how you intend
to pursue
              commercialization and registration in your territories, including
when you anticipate
              taking the next step toward this goal.
Our Strengths, page 4

8.       We note your response to prior comment 6. The majority of the
investors listed on pages
         5 and 125 of the amendment are not disclosed in the principal
stockholder table, and you
         have not undertaken to provide updated information with respect to any
changes these
         investors make with respect to investments in the Company either prior
to the launch of
         the IPO or post-IPO. You have indicated your belief that such entities
are "significant" to
         the Company since your relationships with your "broader investor base
position[s] [you]
         to access and capture attractive business development opportunities,"
as you have
         described on pages 1 and 121 of the amendment. Yet, while such
relationships with
         investors may be significant to the Company, this does not necessarily
mean they are
         material to potential investors in your offering. For these reasons,
the specific identities of
         those entities not listed in the principal stockholder table do not
appear appropriate for
         inclusion in the Summary of the registration statement, as such
information is not among
         the key aspects of the offering or among the most significant aspects
that should be
         considered by potential investors. See Item 503(a) of Regulation S-K.
Please remove this
         disclosure from the Summary.

         In the event you continue to include this disclosure, please explain
why you believe such
         information is material, given you have not committed to undertake to
update
         potential investors on changes in the holdings of these entities
either pre- or post-IPO.
         Additionally, expand your disclosure as follows:
             Describe the nature of the support provided by each investor
identified on pages 5
              and 125 (e.g., identify the round of financing each participated
in);
             Expand your disclosure on pages 5 and 125, by cross-reference or
otherwise, to
              highlight that the largest investors in the "syndicate" are
related parties whose
              investments in the Company are disclosed on pages 228-229, and
indicate the
              aggregate percentage of the approximately $380 million in equity
financing raised
              from your investor syndicate that is attributable to these
related party investors; and
             Disclose whether you have agreements with any of the identified
investors for the
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              placement of additional securities of the Company.
Risk Factors Summary, page 6

9.       In your summary of risk factors, disclose the risks that your
corporate structure and being
         based in or having the majority of the company   s operations in China
and Hong Kong
         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.
10.      We note certain summary risk factor disclosure regarding PCAOB audit
risk in the
         penultimate bullet on page 8. Please supplement the existing
disclosure by stating that
         trading in your securities may be prohibited under the Holding Foreign
Companies
         Accountable Act if the PCAOB determines that it cannot inspect or
fully investigate your
         auditor, and that as a result an exchange may determine to delist your
securities.
11.      We note your response to prior comment 9. In that regard, you have
added summary risk
         factor and other risk factor disclosure on pages 7, 55-56 and 87-88 of
the amendment
         indicating that "Perceptive and its affiliates engage in a broad
spectrum of activities,
         including investments in the healthcare industry generally" and that
in the ordinary course
         of its business activities, Perceptive's interests "may not always
coincide with the
         Company's or minority ADS holders' interests." As applicable, please
revise this
         disclosure to more specifically address how Perceptive's business
activities may conflict
         with your or ADS holders' interests. By way of example only, disclose
         whether Perceptive may invest in or advise businesses that directly or
indirectly compete
         with certain portions of the Company's business or that are suppliers
or customers of the
         Company.
Organizational Structure, page 9

12.      We note your response to prior comment 1. Please revise the diagram to
identify which
         companies are offshore holding entities and which are operating
companies.
Risk Factors, page 15

13.      Given the Chinese government   s significant oversight and discretion
over the conduct of
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         your business, please revise your risk factors to separately highlight
the risk that the
         Chinese government may intervene or influence your operations at any
time, which could
         result in a material change in your operations and/or the value of
your ADSs. Also, given
         recent statements by the Chinese government indicating an intent to
exert more oversight
         and control over offerings that are conducted overseas and/or foreign
investment in China-
         based issuers, acknowledge the risk that any such action 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.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Research and Development Expenses, page 109

14.      We note your response to comment 14. For each of your key research and
development
         projects, please disclose a breakdown of your research and development
expenses on a
         program-by-program basis as previously requested with a reconciliation
to the research
         and development expenses on the Statement of Operations. Item
303(a)(3) of Regulation
         S-K requires you to discuss any significant components of revenues or
expenses in order
         to understand your results of operations.
License and Collaboration Agreements, page 160

15.      We note your response to prior comment 18, and we reissue in part. You
state that your
         royalty obligations will terminate on a product-by-product and
country-by-country basis,
         potentially until the last-to-expire patent in each such country.
Please revise your
         description of the royalty terms to clarify, based on information
known to the Company as
         of the date of the registration statement, when the latest of the
last-to-expire patents for a
         given product is expected to expire in a given country. To that end,
you may provide a
         range of years in which you expect the last-to-expire patent in each
country to expire.
         You may also note, as you have in your response to prior comment 18,
that the expected
         termination of the royalty obligations will depend on factors such as
the filing of
         additional patents covering the licensed product(s) during the term of
the applicable
         agreement, the availability and application of patent term extensions,
and/or expiration of
         regulatory exclusivity for such product(s) in such countries.

16.      With respect to each of your license and collaboration agreements
discussed beginning on
         page 160 of the amendment, please revise the disclosure of the royalty
term to disclose the
         applicable "certain anniversary" of the first commercial sale of the
licensed product at
         which time royalty payments could potentially cease.
MyoKardia Exclusive License Agreement, page 161

17.      Please revise your disclosure regarding your exclusive license
agreement with MyoKardia
         to include each of the dates on which such agreement was amended and,
to the extent
         material, describe the purpose of such amendments.
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Pfizer Strategic Collaboration Agreement, page 163

18.      Please revise your discussion of your strategic collaboration
agreement with Pfizer to
         include a brief description of all material terms of this agreement in
the prospectus,
         including term and termination provisions.
Tarsus Development and License Agreement, page 164

19.      With respect to the development and license agreement between by and
between LianBio
         Ophthalmology Limited and Tarsus Pharmaceuticals, Inc., please revise
your summary of
         the material terms of the agreement on page 165 of the amendment to
disclose the "certain
         minority percentage" of fully diluted equity of Lian Ophthalmology
represented by
         warrants you are or were obligated to issue to Tarsus under the
agreement.
Lyra License and Collaboration Agreement, page 166

20.      With respect to the agreement between LianBio Inflammatory Ltd and
Lyra Therapeutics,
         we note your reference on page 167 of the amendment to "tiered low
double-digit
         royalties." Please revise to narrow the royalty range disclosed for
this agreement to no
         more than ten percentage points.
Notes to Consolidated Financial Statements
Note 2. Significant Accounting Policies
(a) Basis of Presentation, page F-6

21.      You state that the consolidated financial statements include the
accounts of the Company,
         its wholly owned subsidiaries, and controlled entities, which include
the People's Republic
         of China registered entities directly owned by the Company. Please
address the following:
             Tell us what you mean by "controlled entities" and what your
ownership interest is in
              each arrangement. Tell us the significance of these entities to
your total consolidated
              financial statements.
             Clarify if you have any contractual arrangements with the
controlled entities that
              would result in consolidation. If such is the case, please
provide additional disclosure
              of these contractual arrangements.
             Clarify the accounting literature used to consolidate the
controlled entities and your
              basis thereof.
             Confirm that you do not have any variable interest entities, VIEs,
for which you have
              concluded you are the primary beneficiary and consolidate.
             If you have VIEs, please provide the disclosure required by ASC
810-10-50. If the
              VIEs constitute a material part of your consolidated financial
statements, please
              provide in tabular form a condensed consolidating schedule -
depicting the financial
              position, cash flows and results of operations for the parent,
the consolidated variable
              interest entities, and any eliminating adjustments separately -
as of the same dates and
              for the same periods for which audited consolidated financial
statements are required.
              Highlight the financial statement information related to the
variable interest entity
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LianBio
August 19, 2021
Page 8
          and parent, so an investor may evaluate the nature of assets held by,
and the
          operations of, entities apart from the variable interest entity,
which includes the cash
          held and transferred among entities.
Note 3. Material Agreements, page F-12

22.   We note your response to our comment 23. Please address the following:
          Explain the basis of your determination that the warrants issued in
connection with
         your license agreements are related to the equity host instrument and
should be
         classified as equity.
          Clarify on page F-13 the conversion rate of the Myocardia warrants
into ordinary
         shares of the Company.
          You state on page F-12 that you valued the warrants to purchase
100,000 ordinary
         shares in Lian Oncology, a subsidiary of LianBio, at $1.0 million. On
page F-13 you
         granted warrants to purchase 170,000 ordinary shares in Lian
Cardiovascular, a
         subsidiary of LianBio, valued at $33.8 million. Please help us
understand the reason
         for the significant difference in valuation between the two grants,
taking into
         consideration the warrants are to purchase shares of different
subsidiaries of the
         company. Tell us how you determined the current price of the
underlying share of
         $275.00 as disclosed in Note 9(c) on page F-19 for the MyoKardia
warrants
         compared to $10.00 for the QED warrants.
          Please tell us why you believe the $20.0 million upfront payment
received from
         Pfizer to perform Research and Development services is appropriately
considered a
         contra-R&D instead of deferred revenue. It appears that Pfizer is
considered a
         customer and research and development is part of your ongoing major
and central
         operations. Refer to ASC 606 and ASC 808.

       You may contact Christie Wong at 202-551-3684 or Mary Mast at
202-551-3613 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Lauren Hamill at 303-844-1008 or Celeste Murphy at 202-551-3257 with
any other
questions.



                                                            Sincerely,
FirstName LastNameYizhe Wang, Ph.D.
                                                            Division of
Corporation Finance
Comapany NameLianBio
                                                            Office of Life
Sciences
August 19, 2021 Page 8
cc:       Thomas Danielski
FirstName LastName