As filed with the Securities and Exchange Commission on June 22, 2026
Registration No. 333-
Delaware | 56-2020050 | ||
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification Number) | ||
Large accelerated filer | ☐ | Accelerated filer | ☒ | ||||||
Non-accelerated filer | ☐ | Smaller reporting company | ☒ | ||||||
Emerging growth company | ☐ | ||||||||

• | our ability to conduct extensive clinical trials to demonstrate safety and efficacy of our product candidates; |
• | our ability to develop a pipeline of product candidates to address unmet needs in the treatment of organ fibrosis and other inflammatory diseases; |
• | the timing, progress and results of clinical trials for: (i) F351 (hydronidone) from the Phase 2 trial in the United States for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”) associated liver fibrosis; (ii) ETUARYTM from the Phase 3 clinical trial in the PRC for pneumoconiosis (“PD”); (iii) ETUARYTM from an adaptive Phase 2/3 trial in the PRC for radiation-induced lung injury (“RILI”) with or without immune-related pneumonitis; (iv) F573 from the Phase 2 clinical trial in the PRC for the treatment of acute/acute-on-chronic liver failure (“ALF/ACLF”); (v) F230 from the Phase 1 clinical trial in the PRC for the treatment of pulmonary arterial hypertension (“PAH”); and (vi) other product candidates we may develop, including F528, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the studies or trials will become available and research and development programs; |
• | the timing, scope and likelihood of U.S., PRC and comparable foreign regulatory filings and approvals, including timing of investigational new drug (“IND”) applications and final U.S. Food and Drug Administration (“FDA”) and National Medical Products Administration (“NMPA”) approval of F351 for the treatment of liver fibrosis associated with MASH and chronic hepatitis B (“CHB”), respectively, ETUARYTM for the treatment of PD and RILI, F528 for the treatment of chronic obstructive pulmonary disease (“COPD”), F230 for the treatment of PAH, and any other future product candidates; |
• | our expectations regarding the future pursuit of product development efforts, including whether we will pursue such efforts, estimates regarding the expenses, future revenue, timing of any future revenue, capital requirements and need for additional financing related to such efforts, the timing of and our ability to pursue such efforts and our plans to develop and, if approved, subsequently commercialize any product candidates resulting from such efforts; |
• | our expectations regarding our ability to fund our operating expenses and capital expenditure requirements with our cash and investments; |
• | our ability to develop and advance current product candidates and programs into, and successfully complete, clinical studies; |
• | our manufacturing, commercialization and marketing capabilities and strategy; |
• | our product candidates, if approved, including the geographic areas of focus and sales strategy; |
• | the need to hire additional personnel and our ability to attract and retain such personnel; |
• | the size of the market opportunity for our product candidates, including estimates of the number of patients who suffer from the diseases we are targeting; |
• | expectations regarding the approval and use of our product candidates in combination with other drugs; |
• | expectations regarding the potential for accelerated approval or other expedited regulatory designation; |
• | our competitive position and the success of competing therapies that are or may become available; |
• | estimates of the number of patients that we will enroll in our clinical trials; |
• | the beneficial characteristics and the potential safety, efficacy and therapeutic effects of our product candidates; |
• | our ability to obtain and maintain regulatory approval of our product candidates and our expectations regarding particular lines of therapy; |
• | plans relating to the further development of our product candidates, including additional indications we may pursue; |
• | existing regulations and regulatory developments in the PRC, the United States, Europe, and other jurisdictions; |
• | our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering ETUARYTM, EtorelTM (nintedanib ethanesulfonate soft capsules), ContivaTM (avatrombopag maleate tablets), F351, F573, F528, and F230, and other product candidates we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights; |
• | our continued reliance on third parties to conduct additional clinical trials of our product candidates and for the manufacture of our product candidates for clinical trials; |
• | our relationships with patient advocacy groups, key opinion leaders, regulators, the research community and payors; |
• | our ability to obtain and negotiate favorable terms of, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates; |
• | the pricing of, reimbursement of, and potential impact of the PRC’s national centralized drug procurement policy on ETUARYTM, EtorelTM, ContivaTM, F351, F573, F528, and F230, and other product candidates we may develop, if approved and commercialized; |
• | the rate and degree of market acceptance and clinical utility of F351, and other product candidates we may develop; |
• | our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; |
• | our financial performance; |
• | global economic conditions, including new or increased tariffs imposed by the U.S. government and potential retaliatory measures by foreign governments and other barriers to trade, trade and other international disputes, inflation and fluctuating interest rates, slower growth or recession, tighter credit, volatility in financial markets, high unemployment, labor availability constraints, public health crises, significant natural disasters, including as a result of climate change, changes to fiscal and monetary policy or government budget dynamics, particularly in the pharmaceutical and biotech areas, government shutdowns, political and military conflict; |
• | the period over which we estimate our existing cash will be sufficient to fund our planned operating expenses and capital expenditure requirements; |
• | expectations about the continued listing of our Common Stock on Nasdaq; |
• | the impact of laws and regulations; |
• | the outcome of any legal proceedings that may be instituted against us, Cullgen, or any of each company’s respective directors or officers related to the Merger Agreement (as defined herein) or the transactions contemplated thereby; and |
• | the Conversion Approval. |
Name of Selling Stockholders(1) | Common Stock Beneficially Owned Before Offering(2) | Common Stock that May Be Offered Pursuant to Prospectus | Common Stock Beneficially Owned After Offering(2) | |||||||||
Number | Percentage (%) | |||||||||||
BC NovLigase Limited(3) | 954,417 | 954,417 | — | — | ||||||||
Dr. Yue Xiong(4) | 2,376,500 | 2,376,500 | — | — | ||||||||
Galaxy Alpha L.P.(5) | 190,883 | 190,883 | — | — | ||||||||
Entities affiliated with GNI Japan(6) | 86,323,020 | 13,009,130 | 73,313,885 | 65.4% | ||||||||
HSG Venture VII Holdco, Ltd.(7) | 3,750,299 | 3,750,299 | — | — | ||||||||
JT International Capital Management Ltd.(8) | 381,767 | 381,767 | — | — | ||||||||
Name of Selling Stockholders(1) | Common Stock Beneficially Owned Before Offering(2) | Common Stock that May Be Offered Pursuant to Prospectus | Common Stock Beneficially Owned After Offering(2) | |||||||||
Number | Percentage (%) | |||||||||||
Kazuhiro Kawauchi(9) | 11,224 | 11,224 | — | — | ||||||||
MSA China Venture Fund II L.P.(10) | 572,650 | 572,650 | — | — | ||||||||
Neutron Star HK Limited(11) | 2,059,296 | 2,059,296 | — | — | ||||||||
Entities affiliated with Octagon Capital Advisors LP(12) | 954,416 | 954,416 | — | — | ||||||||
Shenzhen Xinxifuxing Investment Partnership (Limited Partnership)(13) | 905,057 | 905,057 | — | — | ||||||||
Sirius Medical Limited(14) | 724,045 | 724,045 | — | — | ||||||||
The Jian Jin and Xufang Ye Revocable Trust(15) | 2,376,500 | 2,376,500 | — | — | ||||||||
Wuxi Guolian Industry Synergy Investment Center (Limited Partnership)(16) | 905,057 | 905,057 | — | — | ||||||||
Yuanqing Bencao Investment Limited(17) | 954,417 | 954,417 | — | — | ||||||||
Satya Das(18) | 10,400 | 10,400 | — | — | ||||||||
Hengxu Wei(19) | 64,402 | 64,402 | — | — | ||||||||
John Sasaki(20) | 16,635 | 16,635 | — | — | ||||||||
Yang Yang(21) | 4,436 | 4,436 | — | — | ||||||||
(1) | To our knowledge, unless otherwise indicated, all persons named in the table above have sole voting and investment power with respect to their shares of Common Stock. Unless an address is provided below, the address for the holder is 12730 High Bluff Drive, Suite 250, San Diego, CA 92130. |
(2) | “Beneficial ownership” is a term broadly defined by the SEC in Rule 13d-3 under the Exchange Act, and includes more than the typical form of stock ownership, that is, stock held in the person’s name. The term also includes what is referred to as “indirect ownership,” meaning ownership of shares as to which a person has or shares investment power. Notwithstanding the foregoing, the beneficial ownership amounts assume the sale of all Common Stock that may be offered pursuant to this prospectus without taking into account certain limitations, including that a holder of Series B Preferred Stock is prohibited from converting shares of Series B Preferred Stock into shares of Common Stock (i) prior to the Conversion Approval, or (ii) if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than a specified percentage (established by the holder between 0.00% and 19.99%) (the “Beneficial Ownership Limitation”) of the total number of shares of Common Stock issued and outstanding immediately after giving effect to such conversion. |
(3) | Consists of 954,417 shares of Common Stock. BC NovLigase Limited is managed by Qianye Karen Liu. BC NovLigase Limited’s address is Trinity Chambers, PO Box 4301, Road Town, Tortola, British Virgin Islands. |
(4) | Consists of 2,376,500 shares of Common Stock issuable upon the conversion of 475,300 shares of Series B Preferred Stock. As of April 1, 2026, shares held by Dr. Yue Xiong were pledged as security pursuant to a lease agreement between Dr. Xiong and GNI USA, Inc., a Delaware corporation (“GNI USA”). The shares of Common Stock issuable upon conversion of the shares of Series B Preferred Stock held by Dr. Xiong are subject to a Beneficial Ownership Limitation of 4.99%. |
(5) | Consists of 190,883 shares of Common Stock held by Galaxy Alpha L.P., a limited partnership incorporated in Cayman Islands. The registered address of Galaxy Alpha L.P. is Maricorp Services Ltd., P.O. Box 2075, #31 the Strand, 46 Canal Point Drive, Grand Cayman KY1-1105, Cayman Islands. HLC GP III Company Limited (“HLC GP”) acts as the general partner of Galaxy Alpha L.P. HLC GP is wholly owned by Mr. Stephen Hui Wang. The voting and investment power of shares held by Galaxy Alpha L.P. is exercised by Mr. Stephen Hui Wang. |
(6) | Consists of (i) 72,773,219 shares of Common Stock held by GNI USA, (ii) 540,666 shares of Common Stock issuable upon conversion of 811 shares of Series X Preferred Stock underlying warrants held by GNI USA, (iii) 10,718,530 shares of Common Stock issuable upon the conversion of 2,143,706 shares of Series B Preferred Stock held by GNI USA and (iv) 2,290,600 shares of Common Stock issuable upon the conversion of 458,120 shares of Series B Preferred Stock held by GNI Group Ltd., a company incorporated under the laws of Japan with limited liability (“GNI Japan”). GNI USA, through GNI Japan-affiliated entities, is a wholly owned subsidiary of GNI Japan. By virtue of such relationship, GNI Japan may be deemed to have voting and investment power with respect to the shares held by GNI USA. The address for these entities is c/o GNI Group Ltd., Nihonbashi-Honcho YS Bldg. 3rd Floor 2-2-2 Nihonbashi-Honcho, Chuo-ku, 103-0023 Tokyo, Japan. The shares of Common Stock issuable upon conversion of the shares of Series B Preferred Stock held by each of GNI USA and GNI Japan are subject to a Beneficial Ownership Limitation of 19.99%. |
(7) | Consists of 3,750,299 shares of Common Stock held by HSG Venture VII Holdco, Ltd., an exempted company with limited liability incorporated under the laws of the Cayman Islands. HSG Venture VII Holdco, Ltd. is wholly owned by HongShan Capital Venture Fund VII, L.P., whose general partner is HSG Venture VII Management, L.P., whose general partner in turn, is HSG Holding Limited. The registered address of HSG Venture VII Holdco, Ltd. is Maples Corporate Services Limited, PO Box 309, Ugland House, South Church Street, Grand Cayman, KY1-1104, Cayman Islands. |
(8) | Consists of 381,767 shares of Common Stock held by JT International Capital Management Limited (“JT International Capital”), a corporation incorporated in Cayman Islands. The registered address of JT International Capital is Campbells Corporate Services Limited, Floor 4, Willow House, Cricket Square, Grand Cayman KY1-9010, Cayman Islands. JT International is controlled by JT Investment Fund SPC South China Venture Capital Healthcare Fund SP (“SCVC Healthcare”). JT International Financial Limited is the fund manager of SCVC Healthcare, and is wholly-owned by Nice Wealth International Holdings Limited, which is in turn wholly-owned by Mr. Ping Hing Tsoi. |
(9) | Consists of 11,224 shares of Common Stock. |
(10) | Consists of 572,650 shares of Common Stock held by MSA China Venture Fund II L.P. MSA China Venture Fund II L.P. is managed by MSA China Fund II GP, LLC, its general partner (“the General Partner”). Yu Zeng is the Manager of the General Partner. MSA China Venture Fund II L.P.’s address is 2106, 21F, Radiance Building, No. 6, Wangjing East Park 4th District, Chaoyang District, Beijing, China. |
(11) | Consists of 2,059,296 shares of Common Stock held by Neutron Star HK Limited, a private company limited by shares registered in Hong Kong (“Neutron Star HK Limited”). The address for Neutron Star HK Limited is Suite 603, 6/F, Laws Commercial Plaza, 788 Cheung Sha Wan Road, Kowloon, Hong Kong. The voting and investment power of shares held by Neutron Star HK Limited is exercised by Mr. Stephen Hui Wang. |
(12) | Consists of (i) 477,208 shares of Common Stock held by Octagon Investments Master Fund L.P. (“Octagon Master Fund”) and (ii) 477,208 shares of Common Stock held by Octagon Coinvest Opportunities Fund L.P. (“Octagon Coinvest Fund”). Octagon Capital Advisors LP (“Octagon”) serves as the investment manager of the Octagon Master Fund and Octagon Coinvest Fund. Dr. Ting Jia, as the principal beneficial owner of Octagon (“Dr. Jia”), is the managing member of Octagon. By virtue of these relationships, each of Octagon and Dr. Jia may be deemed to beneficially own the foregoing shares of our Common Stock. Each of Octagon Master Fund and Octagon Coinvest Fund hold the shares of our Common Stock for the benefit of their respective investors. Each of the Octagon Master Fund, Octagon Coinvest Fund and Octagon, for the benefit of their respective investors, have the right to (1) directly or indirectly alone or with others, vote or dispose of our shares of Common Stock and (2) receive, or the power to direct the receipt of, dividends from, or the proceeds from the sale of, the shares of Common Stock. The address for the foregoing is 654 Madison Avenue, 21st Floor, New York, New York 10065. |
(13) | Consists of 905,057 shares of Common Stock. Shenzhen Xinxifuxing Investment Partnership (Limited Partnership) is managed by Lan Youjin. Shenzhen Xinxifuxing Investment Partnership (Limited Partnership)’s address is 35th Floor, East Tower, Raffles Plaza, North Bund, 1089 Dongdaming Road, Hongkou District, Shanghai, China. |
(14) | Consists of 724,045 shares of Common Stock issuable upon the conversion of 146,241 shares of Series B Preferred Stock held by Sirius Medical Limited. Sirius Medical Limited is managed by Bing Chen. Sirius Medical Limited’s address is 611, T1, South Yanggao Road, Pudong District, Shanghai, China. The shares of Common Stock issuable upon conversion of the shares of Series B Preferred Stock held by Sirius Medical Limited are subject to a Beneficial Ownership Limitation of 4.99%. |
(15) | Consists of 2,376,500 shares of Common Stock issuable upon the conversion of 475,300 shares of Series B Preferred Stock held by a trust, for which Jian Jin and his spouse serve as co-trustees. The shares of Common Stock issuable upon conversion of the shares of Series B Preferred Stock held by the trust are subject to a Beneficial Ownership Limitation of 4.99%. The mailing address for the trust is 13520 Saw Palm Creek Trail, Bradenton, FL 34211. |
(16) | Consists of 905,057 shares of Common Stock held by Wuxi Guolian Industry Synergy Investment Center (Limited Partnership) (“Wuxi Guolian”). Wuxi Guolian is managed by Weimin Zhang. |
(17) | Consists of 954,417 shares of Common Stock held by Yuanqing Bencao Investment Limited (“Yuanqing Bencao”). Yuanqing Bencao is managed by Li Wei Jia. Yuanqing Bencao’s address is Room D1201, Science and Technology Building, Tsinghua Science and Technology Park, Haidan District, Beijing, China. |
(18) | Consists of 10,400 shares of Common Stock. |
(19) | Consists of 64,402 shares of Common Stock. |
(20) | Consists of 16,635 shares of Common Stock. |
(21) | Consists of 4,436 shares of Common Stock. |
• | prior to this time, the Board approved either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder; |
• | upon completion of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding shares owned by persons who are directors and also officers, and by employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or |
• | at or subsequent to such time, the business combination is approved by the Board and authorized at a special or annual stockholders meeting, and not by written consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock that is not owned by the interested stockholder. |
• | any merger or consolidation involving the corporation and the interested stockholder; |
• | any sale, transfer, pledge or other disposition of 10% or more of the assets of the corporation involving the interested stockholder; |
• | any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder, subject to limited exceptions; |
• | any transaction involving the corporation that has the effect of increasing the proportionate share of the stock of any class or series of the corporation beneficially owned by the interested stockholder; or |
• | the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation. |
• | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
• | block trades in which the broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
• | purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
• | an exchange distribution in accordance with the rules of the applicable exchange; |
• | privately negotiated transactions; |
• | settlement of short sales; |
• | in transactions through broker-dealers that agree with the Selling Stockholders to sell a specified number of such securities at a stipulated price per security; |
• | through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
• | in a distribution to members, partners, stockholders or other equityholders of the Selling Stockholders; |
• | a combination of any such methods of sale or distribution; or |
• | any other method permitted pursuant to applicable law. |
• | our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 13, 2026 (including the portions of our Definitive Proxy Statement on Schedule 14A filed on April 27, 2026 incorporated by reference therein); |
• | our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 8, 2026; |
• | our Current Reports on Form 8-K (except for information contained therein which is furnished rather than filed) filed on March 2, 2026, March 23, 2026, April 17, 2026, May 4, 2026 and June 16, 2026; and |
• | the description of our Common Stock attached as Exhibit 4.1 to our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 13, 2026, including any amendment or report filed for the purpose of updating such description. |
Item 14. | Other Expenses of Issuance and Distribution |
SEC registration fee | $24,374 | ||
Printing and engraving | 17,500 | ||
Legal fees and expenses | 250,000 | ||
Accounting fees and expenses | 20,000 | ||
Transfer agent and registrar fees and expenses | 5,000 | ||
Miscellaneous expenses | 55,000 | ||
Total | $371,874 | ||
Item 15. | Indemnification of Officers and Directors |
(1) | to the extent a present or former director or officer of a corporation has been successful on the merits or otherwise in the defense of any action, suit or proceeding referred to in subsections (i) and (ii) of Section 145 or in the defense of any claim, issue or matter therein, such person shall be indemnified against expenses, including attorneys’ fees, actually and reasonably incurred by such person in connection therewith; |
(2) | the indemnification and advancement of expenses provided for pursuant to Section 145 shall not be deemed exclusive of any other rights to which those seeking indemnification or advancement of expenses may be entitled under any bylaw, agreement, vote of shareholders or disinterested directors or otherwise; and |
(3) | the corporation shall have the power to purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against any liability asserted against such person and incurred by such person in any such capacity, or arising out of such person’s status as such, whether or not the corporation would have the power to indemnify such person against such liability under Section 145. |
Item 16. | Exhibits |
Exhibit No. | Description | ||
Agreement and Plan of Merger and Reorganization, dated March 2, 2026, by and among Gyre Therapeutics, Inc., Helix Merger Sub Corp. and Cullgen Inc. (incorporated by reference to Exhibit 2.1 to the Company’s Form 8-K filed on March 2, 2026). | |||
Restated Certificate of Incorporation of Gyre Therapeutics, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Form 10-Q filed on November 13, 2024). | |||
Amended and Restated Bylaws of Gyre Therapeutics, Inc. (incorporated by reference to Exhibit 3.3 to the Company’s Form 8-K filed on October 30, 2023). | |||
Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock, filed with the Delaware Secretary of State on April 10, 2017 (incorporated by reference to Exhibit 3.1 to the Company’s Form 8-K filed on August 13, 2017). | |||
Certificate of Elimination of Series A Preferred Stock, filed with the Delaware Secretary of State on March 25, 2024 (incorporated by reference to Exhibit 3.6(b) to the Company’s Form 10-K filed on March 17, 2024). | |||
Certificate of Designation of Preferences, Rights and Limitations of Series X Convertible Preferred Stock, filed with the Delaware Secretary of State on December 27, 2022 (incorporated by reference to Exhibit 3.1 to the Company’s Form 8-K filed on December 27, 2022). | |||
Amendment to Certificate of Designation of Preferences, Rights and Limitations of Series X Convertible Preferred Stock, filed with the Delaware Secretary of State on October 30, 2023 (incorporated by reference to Exhibit 3.2 to the Company’s Form 8-K filed on October 30, 2023). | |||
Certificate of Designation of Preferences, Rights and Limitations of Series Y Preferred Stock, filed with the Delaware Secretary of State on June 20, 2023, with respect to the Series Y Preferred Stock (incorporated by reference to Exhibit 3.1 to the Company’s Form 8-K filed on June 20, 2023). | |||
Certificate of Elimination of Series Y Preferred Stock, filed with the Delaware Secretary of State on August 31, 2023 (incorporated by reference to Exhibit 3.1 to the Company’s Form 8-K filed on August 31, 2023). | |||
Form of Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock. | |||
Form of Warrant to Purchase Series X Convertible Preferred Stock (incorporated by reference to Exhibit 4.1 to the Company’s Form 8-K filed on October 30, 2023). | |||
Form of Registration Rights Agreement, by and among Gyre Therapeutics, Inc. and certain investors signatory thereto (incorporated by reference to Exhibit 10.3 to the Company’s Form 8-K filed on March 2, 2026). | |||
Opinion of Gibson, Dunn & Crutcher LLP. | |||
Exhibit No. | Description | ||
Form of Company Support Agreement (incorporated by reference to Exhibit 10.2 to the Company’s Form 8-K filed on March 2, 2026). | |||
Form of Lock-Up Agreement (incorporated by reference to Exhibit 10.4 to the Company’s Form 8-K filed on March 2, 2026). | |||
Consent of Grant Thornton Zhitong Certified Public Accountants LLP, Independent Registered Public Accounting Firm. | |||
Consent of Gibson, Dunn & Crutcher LLP (included in Exhibit 5.1). | |||
Power of Attorney (included on the signature page to the registration statement). | |||
Filing Fee Table. | |||
Item 17. | Undertakings |
(a) | The undersigned Registrant hereby undertakes: |
(1) | To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement: |
(i) | to include any prospectus required by Section 10(a)(3) of the Securities Act; |
(ii) | to reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the SEC pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20 percent change in the maximum aggregate offering price set forth in the “Filing Fee Table” in the effective registration statement; and |
(iii) | to include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement; |
(2) | That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
(3) | To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. |
(4) | That, for the purpose of determining liability under the Securities Act to any purchaser: |
(i) | Each prospectus filed by the Registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and |
(ii) | Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act shall be |
(b) | That, for purposes of determining any liability under the Securities Act, each filing of the Registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
(c) | Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers, and controlling persons of the Registrant pursuant to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer, or controlling person of the Registrant in the successful defense of any action, suit, or proceeding) is asserted by such director, officer, or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue. |
GYRE THERAPEUTICS, INC. | ||||||
By: | /s/ Ying Luo | |||||
Ying Luo | ||||||
Chief Executive Officer and President | ||||||
Signature | Title | Date | ||||
/s/ Ying Luo | Chief Executive Officer, President and Director (Principal Executive Officer) | June 22, 2026 | ||||
Ying Luo | ||||||
/s/ Thomas Eastling | Chief Financial Officer (Principal Financial and Accounting Officer) | June 22, 2026 | ||||
Thomas Eastling | ||||||
Chairman | June 22, 2026 | |||||
Ping Zhang | ||||||
/s/ Gordon G. Carmichael, Ph.D. | Director | June 22, 2026 | ||||
Gordon G. Carmichael, Ph.D. | ||||||
/s/ David M. Epstein, Ph.D. | Director | June 22, 2026 | ||||
David M. Epstein, Ph.D. | ||||||
/s/ Rodney L. Nussbaum | Director | June 22, 2026 | ||||
Rodney L. Nussbaum | ||||||
/s/ Renate Parry, Ph.D. | Director | June 22, 2026 | ||||
Renate Parry, Ph.D. | ||||||
/s/ Dan Weng, M.D. | Director | June 22, 2026 | ||||
Dan Weng, M.D. | ||||||
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GYRE THERAPEUTICS, INC.
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Ruoyu Chen | ||
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Chief Financial Officer
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Number of shares of Series B Preferred Stock owned prior to Conversion:
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Number of shares of Series B Preferred Stock to be Converted:
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Number of shares of Common Stock to be Issued:
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Address for delivery of physical certificates:
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| Name: |
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| Title: |
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Re:
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Gyre Therapeutics, Inc.
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Registration Statement on Form S-3
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| Security Type | Security Class Title | Fee Calculation or Carry Forward Rule | Amount Registered | Proposed Maximum Offering Price Per Unit | Maximum Aggregate Offering Price | Fee Rate | Amount of Registration Fee | Carry Forward Form Type | Carry Forward File Number | Carry Forward Initial Effective Date | Filing Fee Previously Paid In Connection with Unsold Securities to be carried Forward | ||
| Newly Registered Securities | |||||||||||||
| | 1 | | | | | $ | $ | | $ | ||||
| Fees Previously Paid | — | — | — | — | — | — | — | ||||||
| Carry Forward Securities | |||||||||||||
| Carry Forward Securities | — | — | — | — | — | — | — | — | — | — | |||
| Total Offering Amounts | $ | $ | |||||||||||
| Total Fees Previously Paid | $ | ||||||||||||
| Total Fee Offsets | $ | ||||||||||||
| Net Fee Due | $ | ||||||||||||
| 1. | Pursuant to Rule 416 under the Securities Act of 1933, as amended (the “Securities Act”), this registration statement also covers such an indeterminate amount of shares of common stock as may become issuable to prevent dilution resulting from stock splits, stock dividends and similar events. The amount registered consists of up to (i) 11,735,356 shares of Common Stock and (ii) 18,486,175 shares of Common Stock issuable upon the conversion of 3,697,235 shares of Series B Preferred Stock. Estimated solely for the purpose of calculating the registration fee, based on the average of the high and low prices of the shares of common stock on the Nasdaq Capital Market on June 16, 2026 (such date being within five business days of the date that this registration statement was first filed with the Securities and Exchange Commission, in accordance with Rule 457(c) under the Securities Act). |