Gyre Therapeutics (GYRE) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Company overview and strategy

• Focuses on anti-fibrotic therapies for chronic organ diseases, with three commercial drugs and a lead candidate, hydronidone (F351), in pivotal phase III trials; top-line results expected early 2025.

• Operates as a NASDAQ-listed company, majority-controlled by Japan's GNI Group, and holds a 65% stake in its Beijing subsidiary.

• Differentiates by targeting chronic inflammation pathways rather than metabolic pathways in organ fibrosis.

• Employs a de-risked R&D approach by developing derivatives of proven compounds and focusing on efficient clinical trial execution.

• Maintains financial sustainability through commercialized products and a focus on innovation in organ fibrosis.

Pipeline and clinical progress

• Three commercial products: pirfenidone and generic nintedanib for IPF, and a thrombocytopenia drug approved in July; nintedanib and avatrombopag to be commercialized later this year.

• F351 is in phase III for HBV-associated liver fibrosis in China, with results due early 2025; phase I completed in the US for MASH-associated fibrosis, with phase II submission planned.

• F573, a caspase inhibitor, is in phase II for acute liver injury; F230 (in collaboration with Eisai) targets pulmonary arterial hypertension and is entering phase I.

• F528, targeting COPD, has completed preclinical validation and is moving toward clinical trials.

• Phase II proof-of-concept for F351 in HBV fibrosis showed significant efficacy, especially at 270 mg/day; phase III enrollment completed, with last patient finishing in October 2024.

Clinical trial design and global expansion

• Phase III-A trial for F351 in HBV fibrosis enrolled 248 patients, using the same clinical endpoints as phase II to confirm efficacy.

• Plans to include both US and China sites in future trials, with ongoing discussions on patient demographics and trial design.

• Considering inclusion of Chinese patients in US trials, with final design pending KOL discussions.

• Aims to leverage validated clinical programs from China for US and global markets to maximize product value.