United States securities and exchange commission logo





                             April 27, 2023

       Nassim Usman, Ph.D.
       President and Chief Executive Officer
       Catalyst Biosciences, Inc.
       611 Gateway Blvd
       Suite 120
       South San Francisco, CA 94080

                                                        Re: Catalyst
Biosciences, Inc.
                                                            Preliminary Proxy
Statement on Schedule 14A
                                                            Filed March 30,
2023
                                                            File No. 000-51173

       Dear Nassim Usman:

              We have reviewed your filing 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 these comments within ten business days by
providing the requested
       information or advise us as soon as possible when you will respond. If
you do not believe our
       comments apply to your facts and circumstances, please tell us why in
your response.

                                                        After reviewing your
response to these comments, we may have additional comments.

       Preliminary Proxy Statement on Schedule 14A filed March 30, 2023

       Letter to Stockholders, page 1

   1.                                                   Provide prominent
disclosure about the legal and operational risks associated with BC
                                                        being based in and
having the majority of its operations in China. Your disclosure should
                                                        make clear whether
these risks could result in a material change in the combined
                                                        company's operations
and/or the value of its securities or could significantly limit or
                                                        completely hinder its
ability to offer securities to investors and cause the value of
                                                        its securities to
significantly decline or be worthless if the business combination is
                                                        executed. 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, have or may impact the combined company   s ability
                                                        to conduct its
business, accept foreign investments, or list on a U.S. or other foreign
                                                        exchange following the
business combination.
 Nassim Usman, Ph.D.
Catalyst Biosciences, Inc.
April 27, 2023
Page 2
2.       Please prominently disclose whether the auditor for the PRC-operations
portion of the
         combined company   s audit would be 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 the combined
company. In addition,
         disclose that trading in your securities may be prohibited under the
Holding Foreign
         Companies Accountable Act if the PCAOB determines that it cannot
inspect or investigate
         completely your auditor, and that as a result an exchange may
determine to delist your
         securities.
3.       Provide a description of how cash is transferred through BC's
organization and disclose
         your intentions to distribute earnings. Regarding BC, state whether
any transfers,
         dividends, or distributions have been made to date between the holding
company, its
         subsidiaries, or to investors, and quantify the amounts where
applicable. Provide a cross-
         reference to the consolidated financial statements.
4.       Where discussing the transaction consideration in the fourth paragraph
of the letter to
         stockholders, please include the valuation expressed as a dollar
figure, as you have done
         on page 3.
5.       Where discussing the percentages of outstanding shares to be held
post-Contribution,
         please clearly state that the pre-Contribution Catalyst stockholders
will go from owning
         83.4% of outstanding shares, as shown on the organizational chart on
page 18, to owning
         2.5% and 2.0%, the latter taking into consideration the conversion of
Convertible
         Preferred Stock and the outstanding options of Catalyst and Gyre
Options to be granted.
Questions and Answers About the Contributions
Who will be the executive officers of the combined company..., page 4

6.       Please revise the table listing the executive officers of the combined
company to indicate
         from which pre-Contribution entity each individual originates.
Catalyst Bioscience, Inc., page 9

7.     We note your statement that a Phase 1 clinical trial of Hydronidone was
completed in the
       U.S.; however, you also state that the company does not anticipate
filing an IND for the
       treatment of NASH in the U.S. until late 2023. Please revise your
disclosure to clarify
       whether an IND was filed with the FDA prior to commencement of the
referenced Phase 1
       clinical trial. In addition, we note your statements that Catalyst plans
to commence a
FirstName LastNameNassim Usman, Ph.D.
       Phase 2a proof-of-concept clinical study. However, it remains unclear
whether the
Comapany    NameCatalyst
       company    has engagedBiosciences,  Inc. and has received approval to
progress as described.
                                 with the FDA
       Please
April 27, 2023explain.
                Page 2
FirstName LastName
 Nassim Usman, Ph.D.
FirstName   LastNameNassim  Usman, Ph.D.
Catalyst Biosciences,  Inc.
Comapany
April       NameCatalyst Biosciences, Inc.
       27, 2023
April 327, 2023 Page 3
Page
FirstName LastName
Summary of the Proxy Statement
The Companies, page 9

8.       Disclose each permission or approval that you, your subsidiaries, BC
or its subsidiaries
         are required to obtain from Chinese authorities to operate their
businesses and to offer
         securities. State whether you, your subsidiaries, BC or its
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 your or BC   s operations, and state affirmatively
whether you and BC
         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, your subsidiaries, BC or its 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.
Beijing Continent Pharmaceuticals Co., Ltd, page 10

9.       Provide a clear description of how cash is transferred through BC   s
organization. Disclose
         your intentions to distribute earnings after the business combination.
Quantify any cash
         flows and transfers of other assets by type that have occurred between
the holding
         company and BC's subsidiaries, and direction of transfer. Quantify any
dividends or
         distributions that a subsidiary have 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. Your
disclosure should
         make clear if no transfers, dividends, or distributions have been made
to date. Describe
         any restrictions on foreign exchange and BC   s ability to transfer
cash between entities,
         across borders, and to U.S. investors. Describe any restrictions and
limitations on BC   s
         ability to distribute earnings from the company, including its
subsidiaries, to the parent
         company and U.S. investors.
10.      We note the following statement on page 10: "The prevalence of IPF in
the PRC increased
         from 83,002 in 2017 to 131,654 in 2022..." Please revise this
statement to clarify the
         meaning of the numbers cited (i.e., number of cases, number of new
patients, etc.).
11.      Please remove the statement on page 10 that the company may "quickly
obtain marketing
         approvals" for the treatment of rare diseases and further expand the
use of drugs, as the
         timing of regulatory approvals is not within the company's control and
cannot be
         predicted.
12.      We note the disclosure on page 10 that Hydronidone was granted
Breakthrough Therapy
         designation by the CDE in March 2021. Please define "CDE" here and
disclose that your
         Breakthrough Therapy designation does not increase the likelihood that
Hydronidone will
         ultimately receive approval.
 Nassim Usman, Ph.D.
FirstName   LastNameNassim  Usman, Ph.D.
Catalyst Biosciences,  Inc.
Comapany
April       NameCatalyst Biosciences, Inc.
       27, 2023
April 427, 2023 Page 4
Page
FirstName LastName
13.      We note disclosure both here and elsewhere throughout the proxy
statement stating or
         inferring that Catalyst and BC   s product candidates are or may be
considered safe and/or
         effective. For example, we note statements that product candidates
have    promising
         efficacy,       potential efficacy,    and    favorable safety.
Please note that determinations of
         safety and efficacy are solely within the authority of the FDA and
comparable regulatory
         bodies; therefore, please revise your prospectus to remove all
references and/or
         implications of safety and efficacy for unapproved product candidates.
You may
         summarize data and findings of studies and trials conducted without
drawing conclusions
         as to these matters.
The Contributions, page 12

14.      Disclose that trading in the post-Contribution company's securities
may be prohibited
         under the Holding Foreign Companies Accountable Act if the PCAOB
determines that it
         cannot inspect or investigate completely your auditor, and that as a
result an exchange
         may determine to delist your securities. Disclose whether the auditor
responsible for the
         combined company   s PRC-operations would be subject to the
determinations announced
         by the PCAOB on December 16, 2021.
15.      Please advise us of the exemption you are relying on for the issuance
of Catalyst shares
         pursuant to the Contributions.
Organizational Structure, page 18

16.      Please provide the following in this section:
             an organizational chart illustrating BC   s structure before the
Contributions;
             graphically indicate how GNI USA, Inc. relates to the shown
entities;
             explain the difference between BJ Continent Pharmaceuticals
Limited and BC in the
             post-Contribution chart, as your disclosure does not clearly
discuss two separate
             entities for BC;
             indicate who holds the remaining 30.3% of BC post-Contribution.
17.      In reference to footnote 2 to the chart, please revise to define
"Entities" here rather than
         referencing the Business Combination Agreement.
Interests of Certain Directors, Officers and Affiliates of Catalyst and the
Contributors
Interests of Catalyst, page 19

18.      Please quantify the dollar value of the grants of awards of fully
vested stock options under
         the 2023 Omnibus Incentive Plan to be granted to Nassim Usman, Seline
Miller and
         Thomas Eastling, as discussed on page 19.
Risk Factor Summary, page 21

19.      Please revise here to describe the dilutive effects to existing
Catalyst stockholders of the
         issuance of stock pursuant to the Contributions.
 Nassim Usman, Ph.D.
Catalyst Biosciences, Inc.
April 27, 2023
Page 5
20.      Please disclose here the risk that the holders of Catalyst Convertible
Preferred Stock could
         be entitled to require Catalyst to redeem, in cash, the shares of
common stock underlying
         its Catalyst Convertible Preferred Stock, causing substantial doubt
about Catalyst   s ability
         to continue as a going concern within one year from the filing of this
proxy statement.
21.      In your summary of risk factors, disclose the risks your corporate
structure and being
         based in or having the majority of the company   s operations in China
after the business
         combination 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 proxy statement. 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 the
combined
         company's 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 the combined company's operations and/or the value
of its securities.
         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
the combined
         company's ability to offer or continue to offer securities to
investors and cause the value
         of such securities to significantly decline or be worthless.
Catalyst stockholders may not realize a benefit from the Contributions
commensurate with the
ownership dilution . . . ., page 29

22.      Please revise here to disclose the amounts and sources of dilution
pursuant to the
         Contributions.
Risks Related to BC   s Business Operations in the PRC
The Chinese government may intervene in or influence BC's operations at any
time, which could
result in a change in BC's operations., page 87

23.      Please revise here to disclose that the risks discussed under this
heading could
         significantly limit or completely hinder the combined company   s
ability to offer or
         continue to offer securities to investors and cause the value of such
securities to
         significantly decline or be worthless.
24.    We note your disclosure on page 250 where you discuss the CSRC published
Trial
FirstName LastNameNassim Usman, Ph.D.
       Measures. Please disclose how, if at all, the Trial Measures apply to
this transaction,
Comapany   NameCatalyst
       whether           Biosciences,
               you and relevant  partiesInc.
                                         to this transaction have complied with
the obligations
       under the Trial
April 27, 2023 Page 5  Measures, and  the risks to investors of non-compliance.
FirstName LastName
 Nassim Usman, Ph.D.
FirstName   LastNameNassim  Usman, Ph.D.
Catalyst Biosciences,  Inc.
Comapany
April       NameCatalyst Biosciences, Inc.
       27, 2023
April 627, 2023 Page 6
Page
FirstName LastName
Risks Related to the Combined Company
The certificate of incorporation and bylaws of the combined company will
provide that the Court
of Chancery of the State of Delaware . . . ., page 101

25.      We note that your forum selection provision of the combined company
will identify the
         Court of Chancery of the State of Delaware as the exclusive forum for
certain litigation,
         including any    derivative action.    Please disclose whether this
provision will apply to
         actions arising under the Securities Act or Exchange Act. In that
regard, we note that
         Section 27 of the Exchange Act creates exclusive federal jurisdiction
over all suits brought
         to enforce any duty or liability created by the Exchange Act or the
rules and regulations
         thereunder, and 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 the
provision applies to Securities
         Act claims, please also revise your proxy statement to state that
there is uncertainty as to
         whether a court would enforce such provision and that investors cannot
waive compliance
         with the federal securities laws and 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
states this clearly,
         or tell us how you will inform investors in future filings that the
provision does not apply
         to any actions arising under the Securities Act or Exchange Act.
The Contributions
Catalyst's Background of the Contributions, page 114

26.      Please revise here to discuss the negotiations between the parties
leading to Nassim
         Usman, Ph.D. remaining as a director and Seline Miller remaining as an
executive officer
         of the combined company.
Opinion of Catalyst's Financial Advisor, page 118

27.      Please revise here to disclose whether there were any material changes
made to the draft
         documents reviewed by Raymond James disclosed on page 119. If so,
disclose those
         changes.
28.      We note you state here that the Raymond James fairness opinion is
attached to this proxy
         statement as Annex C. Annex C appears to be an accounting consent and
the full text of
         the opinion does not appear elsewhere in the proxy statement. Please
attach the opinion to
         the proxy statement or otherwise advise.
29.      Please revise your disclosure to summarize Raymond James    discounted
cash flow
         analysis and any other valuation analyses conducted in preparation for
rendering
         the fairness opinion. Please also summarize the projections provided
to Raymond James
         and used in reaching the fairness determination and disclose the
assumptions and bases
         relied related thereto.
 Nassim Usman, Ph.D.
FirstName   LastNameNassim  Usman, Ph.D.
Catalyst Biosciences,  Inc.
Comapany
April       NameCatalyst Biosciences, Inc.
       27, 2023
April 727, 2023 Page 7
Page
FirstName LastName
30.      Please revise to quantify the amount of compensation paid by Catalyst
to Raymond James
         and its affiliates over the past two years.
The Business Combination Agreement
Conditions to the Completion of the Contributions, page 137

31.      We note you disclose here that conditions to the completion of the
contributions are
         subject to the satisfaction or waiver by each of the parties. Please
revise to state which
         conditions may be waived and revise your Risk Factors if applicable.
Catalyst's Business
Summary, page 193

32.      We note your statement that Hydronidone performed better than
Pirfenidone at
         comparable dose in the murine NASH model. Please revise your
disclosure to provide
         information regarding any head-to-head trials conducted comparing
Hydronidone to
         Pirfenidone directly. If head-to-head trials were not conducted,
please remove this
         statement and any similar comparisons.
Hydronidone Pre-Clinical Development in NASH, page 198

33.      We note you plan to use clinical data obtained in the recently
completed Phase 2 clinical
         study of Hydronidone conducted by BC in the PRC. Please revise here to
disclose the
         FDA may not accept the data from this clinical study and provide risk
factor disclosure
         that the FDA may require you to conduct additional trials if it does
not accept data from
         BC   s clinical study or believes that additional data is necessary to
supplement your
         clinical study data.
Intellectual Property, page 200

34.      Please revise page 201 to disclose all jurisdictions related to the
granted patents for your
         first and second patent families. Please also include the expiration
dates or years of each.
Our Clinical-Stage Product - Hydronidone: A Drug to Reverse Liver Fibrosis
Associated with
CHB, page 218

35.      Please remove your statement that    Hydronidone is expected to remain
the only approved
         anti-fibrosis drugs for the treatment of CHB in the PRC, for at least
a few years after
         approval, according to Frost & Sullivan" as such statement is
premature at this stage of
         development and implies not only that regulatory approval will be
obtained, which is
         outside of the control of the company and unknown, but also that no
competitors will
         develop competing products in the interim.
Phase 2 Study of Hydronidone for liver fibrosis associated with CHB in the PRC,
page 220

36.      Please expand BC   s discussion of the SAEs observed in the Phase 2
study of Hydronidone
         to describe the SAEs.
 Nassim Usman, Ph.D.
Catalyst Biosciences, Inc.
April 27, 2023
Page 8
F573: Potential Category 1 New Drug for ALF/ACLF, page 221

37.      Please revise here to summarize the results of the Phase 1 clinical
trial for F573. To the
         extent results are not yet available, state when BC expects to receive
them. Regarding the
         Phase 2 trial, disclose the trial design, primary and secondary
endpoints.
Our Preclinical-Stage Product Candidates, page 222

38.      Please revise your discussion of the F528 and F230 preclinical studies
to state whether
         results you refer to are statistically significant.
Intellectual Property, page 232

39.      Please revise this section to disclose the type of patent protection
(e.g., composition of
         matter, use, or process) and the expected expiration dates, on an
individual or patent
         family basis, for all material patents owned by BC.
BC Management's Discussion and Analysis of Financial Condition and Results of
Operations,
page 260
Results of Operations, page 264

40.      We note from page F-57 that BC's trade receivables increased 70%
during 2022, as
         compared to an increase of 21% in total RMB revenues. Please explain
the reason(s) for
         why trade receivables have increased at a significantly faster rate
than revenues. Quantify
         how much of the balance has been collected subsequent to December 31,
2022.
41.      As disclosed on page 265, we note that BC's gross profit margin has
approximated 96% in
         each of the last two years. Please revise the disclosure to explain
how BC has maintained
         such a high level of gross profit margin and/or why raw materials and
the remaining
         components of cost of sales, if applicable, is so low. Additionally,
describe any known
         trends or uncertainties that have had or that are reasonably likely to
have a material
         favorable or unfavorable impact on revenues or gross profit margins.
Refer to
         Item 303(b)(2)(ii) of Regulation S-K.
BC Financial Statements, page F-32

42.    Based on the disclosures discussed on pages 94-95 and 248-249 regarding
restrictions on
       the ability of BC's Chinese subsidiaries to remit sufficient foreign
currency to offshore
FirstName LastNameNassim Usman, Ph.D.
       entities for such offshore entities to be able to pay dividends, make
other payments or
Comapany    NameCatalyst
       otherwise            Biosciences,
                  satisfy BC's            Inc.
                                foreign-currency-denominated     obligations,
please address the need
       for BC  to provide
April 27, 2023 Page 8      the Schedule  I per Rule 5-04(c)  of Regulation
S-X.
FirstName LastName
 Nassim Usman, Ph.D.
FirstName   LastNameNassim  Usman, Ph.D.
Catalyst Biosciences,  Inc.
Comapany
April       NameCatalyst Biosciences, Inc.
       27, 2023
April 927, 2023 Page 9
Page
FirstName LastName
11. Intangible Assets, page F-55

43.      We note product development in progress accounts for most of the
intangible assets
         balance. It is not clear to us why such costs are classified as
intangible assets. Please
         identify the transactions that have resulted in these amounts and/or
address why these
         costs, referring to the disclosure on page F-39, are not accounted for
as inventories.
        We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.

       You may contact Jenn Do at 202-551-3743 or Lynn Dicker at 202-551-3616
if you have
questions regarding comments on the financial statements and related matters.
Please contact
Daniel Crawford at 202-551-7767 or Laura Crotty at 202-551-7614 with any other
questions.



                                                                Sincerely,

                                                                Division of
Corporation Finance
                                                                Office of Life
Sciences
cc:      Stephen B. Thau, Esq.