UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549



FORM 8-K



CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): November 6, 2023

Gyre Therapeutics, Inc.
(Exact name of registrant as specified in its charter)

Delaware
000-51173
56-2020050
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification No.)
     
12730 High Bluff Drive
Suite 250
San Diego, CA
92130
(Address of principal executive offices)
(Zip Code)

Registrant’s telephone number, including area code: (650) 266-8674

N/A
(Former name or former address, if changed since last report)



Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class
 
Trading Symbol(s)
 
Name of each exchange on which
registered
Common Stock
 
GYRE
 
The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.



Item 7.01. Regulation FD Disclosure.

On November 6, 2023, GNI Group Ltd., a company incorporated under the laws of Japan with limited liability (“GNI Japan”), which holds an indirect controlling interest of Gyre Therapeutics, Inc., a Delaware corporation (the “Company”), issued a press release announcing that GNI Japan has updated the consolidated earnings forecast for the full-year 2023.

A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein. The exhibit furnished under Item 7.01 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act, regardless of any general incorporation language in such filing.

Forward Looking Statements

This report and the press release attached as an exhibit contain forward-looking statements that pertain to future operating performance and that are not historic facts. Forward-looking statements may include, but are not limited to, words such as “believe,” “plan,” “strategy,” “expect,” “forecast,” “possibility” and similar words that describe future operating activities, business performance, events or conditions. Forward-looking statements, whether spoken or written, are based on judgments made by the management of GNI Japan and/or the Company, based on information that is currently available to it. As such, these forward-looking statements are subject to various risks and uncertainties, and actual business results may vary substantially from the forecasts expressed or implied in forward-looking statements. Consequently, investors are cautioned not to place undue reliance on forward-looking statements.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits. The following exhibits are being furnished herewith:


Exhibit Number
 
Exhibit Title or Description
     
 
Press Release, dated November 6, 2023
     
104
 
Cover Page Interactive Data File (embedded within the Inline XBRL document)



SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 
GYRE THERAPEUTICS, INC.
   
Date: November 6, 2023
By:
/s/ Charles C. Wu, Ph.D.
 
Name:
Charles C. Wu, Ph.D.
 
Title:
Chief Executive Officer



Exhibit 99.1


Nov 6, 2023

 
Company Name:
GNI Group Ltd.
 
Representative:
Director, Representative Executive Officer,
President and CEO
Ying Luo, PhD
   
(Security Code: 2160, TSE Growth)
 
Contact Person:
Chief Financial Officer
Toshiya Kitagawa
   
(TEL. 03-6214-3600)

GNI Group Updates Full Year 2023 Consolidated Earnings Forecast

GNI Group Ltd., (TSE Growth security code: 2160, “the Company” below) today announced that the Group has updated the consolidated earnings forecast for the full-year 2023, which was published on August 3, 2023, as follows.

1)
The differences between the forecast and the previous forecast for 2023

Consolidated earnings forecast for full-year 2023 (January 1, 2023 – December 31, 2023)

 
Revenue
Operating profit
Profit before tax
Profit for the year
Profit attributable to owners of the parent
Basic earnings per share
(JPY Million)
(JPY Million)
(JPY Million)
(JPY Million)
(JPY Million)
(JPY)
Previous Forecast (A)
25,273
5,991
4,143
2,174
1,703
35.86
Revised Forecast (B)
26,267
7,280
6,430
4,351
2,005
42.20
Difference (B-A)
994
1,289
2,287
2,177
302
-
Difference in ratio (%)
3.9%
21.5%
55.2%
100.1%
17.7%
-
(Reference) 2022 Actual
17,418
1,377
767
(868)
388
8.19

2)
Reasons for the differences

The first is that the sales revenue of ETUARY®, the main product of our consolidated subsidiary, Beijing Continent Pharmaceuticals Co., Ltd., has been exceeding the plan in the second half of the fiscal year as in the first half.

Second, as disclosed on June 15, 2023, our consolidated subsidiary Cullgen Inc. is generating monthly sales revenue that exceeds the previous forecast based on the strategic alliance agreement signed with Astellas Pharma Inc.

Third, the exchange rates previously used for earnings forecast (US$1 = ¥130.77 and RMB1 = ¥19.38) have been revised to US$1 = ¥138.24 and RMB1 = ¥19.62.

As a result of these factors, revenue and profit are expected to significantly exceed the full-year forecast announced on August 3, 2023, and we have now revised our full-year consolidated forecast.



This material contains statements concerning the current plans, expectations and strategies of GNI Group Ltd. (“the Company”). Any statements contained herein that pertain to future operating performance and that are not historic facts are forward-looking statements. Forward-looking statements may include, but are not limited to, words such as “believe,” “plan,” “strategy,” “expect,” “forecast,” “possibility” and similar words that describe future operating activities, business performance, events or conditions. Forward-looking statements, whether spoken or written, are based on judgments made by the management of the Company, based on information that is currently available to it. As such, these forward-looking statements are subject to various risks and uncertainties, and actual business results may vary substantially from the forecasts expressed or implied in forward-looking statements. Consequently, investors are cautioned not to place undue reliance on forward-looking statements.

The information contained in this material does not constitute or form part of any offer for sale or subscription of or solicitation or invitation of any offer to buy or subscribe for any securities, nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. Any decision to invest in or acquire securities of the Company must be based wholly on the information contained in the preliminary offering circular issued or to be issued by the Company in connection with any such offer and not on the contents hereof.