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Gyre Therapeutics Announces Proposed Underwritten Public Offering of Common Stock

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Gyre Therapeutics (NASDAQ: GYRE) has announced a proposed underwritten public offering of common stock shares. The biotechnology company, focused on organ fibrosis, will grant underwriters a 30-day option to purchase additional shares at the public offering price. The net proceeds will fund multiple initiatives, including: - Advancing Phase 2 clinical trial of F351 for MASH-associated liver fibrosis in the US - Research and development activities - Manufacturing and scale-up operations - Working capital and general corporate purposes Jefferies is serving as the lead book-running manager, with H.C. Wainwright & Co. as co-manager. The offering will be made through a shelf registration statement previously filed with the SEC.
Gyre Therapeutics (NASDAQ: GYRE) ha annunciato un'offerta pubblica sottoscritta di azioni ordinarie. La società biotecnologica, specializzata nella fibrosi degli organi, concederà agli sottoscrittori un'opzione di 30 giorni per acquistare azioni aggiuntive al prezzo dell'offerta pubblica. Il ricavato netto finanzierà diverse iniziative, tra cui: - Avanzamento della sperimentazione clinica di F351 in fase 2 per la fibrosi epatica associata a MASH negli Stati Uniti - Attività di ricerca e sviluppo - Operazioni di produzione e aumento della capacità - Capitale circolante e scopi aziendali generali Jefferies è il gestore principale del libro ordini, con H.C. Wainwright & Co. come co-gestore. L'offerta sarà effettuata tramite una dichiarazione di registrazione a scaffale precedentemente depositata presso la SEC.
Gyre Therapeutics (NASDAQ: GYRE) ha anunciado una oferta pública suscrita de acciones comunes. La compañía biotecnológica, centrada en la fibrosis de órganos, otorgará a los suscriptores una opción de 30 días para comprar acciones adicionales al precio de la oferta pública. Los ingresos netos financiarán múltiples iniciativas, incluyendo: - Avanzar el ensayo clínico de fase 2 de F351 para fibrosis hepática asociada a MASH en EE. UU. - Actividades de investigación y desarrollo - Operaciones de fabricación y ampliación - Capital de trabajo y propósitos corporativos generales Jefferies actúa como administrador principal del libro de órdenes, con H.C. Wainwright & Co. como coadministrador. La oferta se realizará mediante una declaración de registro en estantería previamente presentada ante la SEC.
Gyre Therapeutics(NASDAQ: GYRE)는 보통주 공모를 위한 인수 공모를 제안했다고 발표했습니다. 장기 섬유증에 집중하는 이 바이오테크 회사는 인수인들에게 공모가로 추가 주식을 30일간 매수할 수 있는 옵션을 부여할 예정입니다. 순수익금은 다음과 같은 여러 프로젝트에 사용될 예정입니다: - 미국 내 MASH 관련 간 섬유증 치료제 F351의 2상 임상시험 진행 - 연구 개발 활동 - 제조 및 생산 규모 확대 - 운전자본 및 일반 기업 운영 자금 Jefferies가 주간사로 참여하며, H.C. Wainwright & Co.가 공동 주간사로 참여합니다. 이번 공모는 SEC에 사전 제출된 선반 등록 신고서를 통해 진행됩니다.
Gyre Therapeutics (NASDAQ : GYRE) a annoncé une offre publique souscrite d'actions ordinaires. La société biotechnologique, spécialisée dans la fibrose des organes, accordera aux souscripteurs une option de 30 jours pour acheter des actions supplémentaires au prix de l'offre publique. Le produit net financera plusieurs initiatives, notamment : - L'avancement de l'essai clinique de phase 2 de F351 pour la fibrose hépatique associée au MASH aux États-Unis - Les activités de recherche et développement - Les opérations de fabrication et d'augmentation de capacité - Le fonds de roulement et les besoins généraux de l'entreprise Jefferies agit en tant que gestionnaire principal, avec H.C. Wainwright & Co. comme co-gestionnaire. L'offre sera réalisée via une déclaration d'enregistrement en étagère déposée précédemment auprès de la SEC.
Gyre Therapeutics (NASDAQ: GYRE) hat eine geplante öffentlich angebotene Aktienemission mit Underwriting angekündigt. Das Biotechnologieunternehmen, das sich auf Organfibrose spezialisiert hat, gewährt den Underwritern eine 30-tägige Option zum Kauf zusätzlicher Aktien zum öffentlichen Angebotspreis. Die Nettoerlöse werden mehrere Initiativen finanzieren, darunter: - Fortschreiten der Phase-2-Studie von F351 für MASH-assoziierte Leberfibrose in den USA - Forschungs- und Entwicklungsaktivitäten - Produktion und Skalierung - Betriebskapital und allgemeine Unternehmenszwecke Jefferies fungiert als Hauptbuchführer, mit H.C. Wainwright & Co. als Co-Manager. Das Angebot erfolgt über eine zuvor bei der SEC eingereichte Shelf-Registration-Erklärung.
Positive
  • Proceeds will advance Phase 2 clinical trial of F351 for MASH-associated liver fibrosis
  • Company has commercial-stage status in biotechnology sector
  • Multiple established financial institutions supporting the offering (Jefferies and H.C. Wainwright & Co.)
  • Effective shelf registration statement already in place with SEC
Negative
  • Potential dilution of existing shareholders' value
  • Uncertainty regarding the offering size and terms
  • No guarantee of offering completion due to market conditions

Insights

Gyre is diluting shareholders through a new stock offering to fund MASH clinical trials and operations, indicating potential cash needs.

Gyre Therapeutics has announced a proposed underwritten public offering of common stock, which typically results in share dilution for existing investors. This offering structure, with Jefferies as lead book-runner and H.C. Wainwright as co-manager, suggests the company is pursuing a traditional follow-on offering to raise additional capital.

The company has stated that proceeds will fund several critical initiatives: advancing its Phase 2 clinical trial of F351 in metabolic dysfunction-associated steatohepatitis (MASH)-associated liver fibrosis in the United States, continuing research and development activities, expanding manufacturing capabilities, and supporting general corporate operations.

This financing comes despite Gyre being described as "commercial-stage," which indicates the company has revenue-generating products but likely insufficient cash flow to fully fund its clinical development programs. The MASH indication represents a substantial market opportunity, as this condition affects millions globally with few approved treatments, but requires significant capital investment for clinical development.

The offering includes a 30-day option for underwriters to purchase additional shares, a standard arrangement that could increase the total capital raised. While the company has filed a shelf registration statement (effective November 2024), specific pricing and share quantity details remain undisclosed, creating uncertainty about the exact level of dilution existing shareholders will experience.

This financing approach suggests the company may be facing cash constraints or sees an opportunity to strengthen its balance sheet before potentially more challenging market conditions. Investors should monitor the final terms and pricing of this offering to assess its immediate impact on share value and the company's new cash runway.

SAN DIEGO, May 22, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced that it has commenced an underwritten public offering of shares of its common stock. In addition, Gyre is expected to grant the underwriters of the offering an option for a period of 30 days to purchase additional shares of its common stock at the public offering price, less the underwriting discounts and commissions. The proposed public offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. All of the shares of common stock to be sold in the offering are being offered by Gyre.

Gyre intends to use the net proceeds from this offering, together with its existing cash and cash equivalents and cash flows from operations, to advance its Phase 2 clinical trial of F351 in metabolic dysfunction-associated steatohepatitis (“MASH”)-associated liver fibrosis in the United States, for research and development, manufacturing and scale-up, as well as for working capital and general corporate purposes.

Jefferies is acting as lead book-running manager for the offering and H.C. Wainwright & Co. is acting as co-manager for the offering.

The shares of common stock described above are being offered pursuant to a shelf registration statement filed with the Securities and Exchange Commission (“SEC”) that was declared effective by the SEC on November 22, 2024. The offering will be made only by means of a prospectus, including a prospectus supplement, forming a part of an effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website, located at www.sec.gov. Prospective investors should read the preliminary prospectus supplement and the accompanying prospectus and other documents Gyre has filed with the SEC for more complete information about Gyre and the offering. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus related to the offering may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@jefferies.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Gyre Therapeutics

Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis, including MASH, in the U.S. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the People’s Republic of China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and F230.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: Gyre’s expectations regarding the offering, including the timing, size, structure and completion of the proposed offering on the anticipated terms; the grant to the underwriters of the option to purchase additional shares; and the expected use of net proceeds from the offering. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions relating to the offering; Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings Gyre may make with the SEC.

Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

Investor Contact:
David Zhang
Gyre Therapeutics
david.zhang@gyretx.com


FAQ

What is the purpose of GYRE's public offering of common stock?

The offering's proceeds will fund Phase 2 clinical trials of F351, research and development, manufacturing scale-up, working capital, and general corporate purposes.

How will GYRE's stock offering affect existing shareholders?

The offering will likely dilute existing shareholders' value as new shares are issued, though the exact impact depends on the offering size and terms, which haven't been disclosed.

Who are the underwriters for GYRE's public offering?

Jefferies is acting as lead book-running manager, while H.C. Wainwright & Co. is serving as co-manager for the offering.

What is GYRE's main clinical focus with the offering proceeds?

The proceeds will primarily advance Phase 2 clinical trials of F351 in metabolic dysfunction-associated steatohepatitis (MASH)-associated liver fibrosis in the United States.

When was GYRE's shelf registration statement declared effective by the SEC?

The shelf registration statement was declared effective by the SEC on November 22, 2024.
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