Correspondence 0001140361-23-024688 from GYRE THERAPEUTICS, INC. (GYRE) (CIK 0001124105) (GYRE)
GYRE THERAPEUTICS, INC. (GYRE) (CIK 0001124105)
Date: May 15, 2023 · CIK: 0001124105 · Accession: 0001140361-23-024688
AI Filing Summary & Sentiment
File numbers found in text: 000-51173
Referenced dates: April 27, 2023
Show Raw Text
CORRESP
1
filename1.htm
May 15, 2023
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance, Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Attn: Jenn Do
Lynn Dicker
Daniel Crawford
Laura Crotty
Orrick, Herrington & Sutcliffe LLP
51 West 52nd Street
New York, NY 10019-6142
+1 212 506 5000
orrick.com
Stephen Thau
E sthau@orrick.com
D +1 212 506 5076
F +1 212 506 5151
Re:
Catalyst Biosciences, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed March 30, 2023
File No. 000-51173
Ladies and Gentlemen:
On behalf of Catalyst Biosciences, Inc., a Delaware corporation (the “Company”), set forth below is the response of the Company to the comments of the staff of the Division of Corporation Finance,
Office of Life Sciences (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) contained in the letter dated April 27, 2023 (the “Comment Letter”) regarding the Company’s Preliminary Proxy Statement on
Schedule 14A (the “Proxy Statement”) filed with the Commission on March 30, 2023.
Concurrently with this response letter, the Company is filing Amendment No. 1 to the Proxy Statement (the “Amendment”) via EDGAR. The Amendment includes revisions made in response to the comments
of the Staff in the Comment Letter, as well as additional changes to update certain disclosure contained in the Proxy Statement.
To facilitate your review, we have reproduced the text of the Staff’s comments in boldfaced print below, followed by the Company’s response. We are also providing, on a supplemental basis, a copy of the
Amendment that has been marked to show changes made to the originally-filed Proxy Statement.
Preliminary Proxy Statement on Schedule 14A
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.
U.S. Securities and Exchange Commission
May 15, 2023
Page 2
Response:
The Company has revised the disclosure on pages 2 and 3 of the Letter to Stockholders of the Amendment to address the Staff’s comment. In addition, the Company respectfully notes to the Staff that such disclosure is
prominently displayed elsewhere in the Amendment.
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.
Response:
The Company has revised the disclosure on pages 3 and 4 of the Letter to Stockholders of the Amendment to address the Staff’s comment. In addition, the Company respectfully notes to the Staff that such disclosure is
prominently displayed elsewhere in the Amendment.
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.
Response:
The Company has revised the disclosure on page 3 of the Letter to Stockholders of the Amendment to address the Staff’s comment. In addition, the Company respectfully notes to the Staff that such disclosure is prominently
displayed elsewhere in the Amendment.
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.
Response:
The Company has revised the disclosure on pages 1 and 2 of the Letter to Stockholders of the Amendment to address the Staff’s comment. In addition, the Company respectfully notes to the Staff that such disclosure is
prominently displayed elsewhere in the Amendment.
U.S. Securities and Exchange Commission
May 15, 2023
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.
Response:
The Company has revised the disclosure on pages 1 and 2 of the Letter to Stockholders of the Amendment and 33 of the Amendment to address the Staff’s comment.
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.
Response:
The Company has revised the disclosure on pages 4 and 22 of the Amendment to address the Staff’s comment.
Catalyst Biosciences, 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
Phase 2a proof-of-concept clinical study. However, it remains unclear whether the company has engaged with the FDA and has received approval to progress as described. Please explain.
Response:
The Company has revised the disclosure on pages 9, 207 and 211 of the Amendment to address the Staff’s comment.
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.
U.S. Securities and Exchange Commission
May 15, 2023
Page 4
Response:
The Company has revised the disclosure on pages 26-27 and 241-242 of the Amendment to address the Staff’s comment.
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.
Response:
The Company has revised the disclosure on pages 12-13 and 264-265 of the Amendment to address the Staff’s comment.
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.).
U.S. Securities and Exchange Commission
May 15, 2023
Page 5
Response:
The Company has revised the disclosure on pages 10, 72, 228, 229, 232, 233, 235, 236 and 237 of the Amendment to address the Staff’s comment.
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.
Response:
The Company has revised the disclosure on pages 10 and 277 of the Amendment to address the Staff’s comment.
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.
Response:
The Company has revised the disclosure on pages 11, 45 and 225 of the Amendment to address the Staff’s comment.
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.
Response:
The Company has revised the disclosure on pages 11, 43, 209, 225, 231, 232, 233, 234, 235, 236 and 239 of the Amendment to address the Staff’s comment.
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.
U.S. Securities and Exchange Commission
May 15, 2023
Page 6
Response:
The Company has revised the disclosure on page 15 of the Amendment to address the Staff’s comment.
15.
Please advise us of the exemption you are relying on for the issuance of Catalyst shares pursuant to the Contributions.
Response:
The Company respectfully advises the Staff that the Catalyst Common Stock and Catalyst Convertible Preferred Stock issued in the Contributions will be issued in transactions exempt from registration under the Securities
Act of 1933, as amended, in reliance on Section 4(a)(2) thereof.
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.
Response:
The Company has revised the disclosure on page 21 of the Amendment to address the Staff’s comment.
17.
In reference to footnote 2 to the chart, please revise to define “Entities” here rather than referencing the Business Combination Agreement.
Response:
The Company has revised the disclosure on page 21 of the Amendment to address the Staff’s comment.
Interests of Certain Directors, Officers and Affiliates of Catalyst and the Contributors
Interests of Catalyst, page 19
U.S. Securities and Exchange Commission
May 15, 2023
Page 7
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.
Response:
The Company respectfully advises that it will provide information regarding quantifying 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 in a subsequent amendment.
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.
Response:
The Company has revised the disclosure on page 24 of the Amendment to address the Staff’s co