Gyre Therapeutics, Inc. (GYRE) Market Cap
Gyre Therapeutics, Inc. has a market capitalization of $714.5M.
Financials based on reported quarter end 2025-12-31
Price: $7.83
▼ -0.04 (-0.57%)
Market Cap: 714.53M
NASDAQ · time unavailable
CEO: Ping Zhang
Sector: Healthcare
Industry: Biotechnology
IPO Date: 2006-04-12
Website: https://www.gyretx.com
Gyre Therapeutics, Inc. (GYRE) - Company Information
Market Cap: 714.53M · Sector: Healthcare
Gyre Therapeutics, Inc., a pharmaceutical company, engages in the development and commercialization of small-molecule, anti-inflammatory, and anti-fibrotic drugs targeting organ fibrosis. It offers ETUARY (Pirfenidone), an anti-fibrotic drug approved for the treatment of idiopathic pulmonary fibrosis; and under phase 3 studies for dermatomyositis and systemic sclerosis-associated interstitial lung disease, pneumoconiosis, and diabetic kidney disease. The company is also involved the development of F351 (Hydronidone), a structural derivative of ETUARY (Pirfenidone), under Phase 3 studies for the treatment of chronic hepatitis B liver fibrosis; and under Phase 1 studies for liver fibrosis associated with nonalcoholic associated steatohepatitis. In addition, its development pipeline includes F573, under Phase 2 studies for the treatment of acute/acute-on-chronic liver failure; F528, under preclinical stage for the treatment of chronic obstructive pulmonary disease; and F230, under preclinical stage for the treatment of pulmonary arterial hypertension. The company was founded in 2002 and is headquartered in San Diego, California. Gyre Therapeutics, Inc. operates as a subsidiary of GNI USA, Inc.
Analyst Sentiment
Based on 1 ratings
Analyst 1Y Forecast: $17.00
Average target (based on 1 sources)
Consensus Price Target
Low
$16
Median
$17
High
$18
Average
$17
Potential Upside: 117.3%
Price & Moving Averages
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Fundamentals Overview
Management’s tone is confident about the strategic pivot (MarzAA efficacy not questioned) and upbeat on complement’s long-term value, highlighting operational steps: cutting burn ~40%, preserving ~$64.5M cash, and pushing CB 4332 toward a 2022 IND with end-of-year initial PK expectations. However, the Q&A reveals the real driver: slow MarzAA enrollment from pandemic logistics plus growing prophylaxis competition, leading to a feasibility conclusion that financing completion required a partner. The timeline shift is stark—MAA-304/Crimson-1 completion estimated late 2023 due to a ~14-month DSM-V-related “last patient” burden—overriding earlier year-end submission and 2022 pivotal-data aspirations. Analysts probing immunogenicity, partner milestones, and cash runway met controlled responses (Biogen controls news flow; partnership cash milestones not quantified). Data sharing for MarzAA is delayed by trial wind-down and mandatory safety follow-up (“a couple of months”). Net: proactive pivot, but credibility under pressure from funding and enrollment reality.
Growth Catalysts
- Strategic pivot away from MarzAA to complement/protease platform focus
- Progression of CB 4332 (subcu enhanced complement factor I replacement) toward IND and first-in-human
- Natural history enrollment momentum via ConFIdence study (first 2 complement factor I-deficient subjects enrolled)
- CB 2782-PEG (C3 degrader) ongoing preclinical work via Biogen; transfer of Catalyst-supported activities planned
Business Development
- Biogen partnership for CB 2782-PEG; Biogen controls news flow; Catalyst supports IND-enabling activities
- Exploring opportunities to license or sell MarzAA and DalcA portfolios (no named third parties disclosed)
- Business development efforts ongoing to secure a partner to finance/enable MarzAA completion (specific outreach targets not disclosed)
Financial Highlights
- Cash reported: $64.5 million as of September 30, 2021
- Halting MarzAA expected to reduce burn by ~40% via headcount and CRO cost reductions
- Explicit burn/rate discussion: analyst assumed burn a little over $20 million/quarter in 2021; management affirmed ~1 year of runway (40% reduction implied ~to ~$13 million/quarter per analyst math)
- MarzAA timeline estimate: MAA-304/Crimson-1 could complete by late 2023 (driven by slow enrollment); financing hurdle could not be overcome without a partner
- CB 2782-PEG milestones: next milestone indicated as 'entering the clinic' (milestone amount/timing not specified)
Capital Funding
- Reported cash: $64.5 million (Sep 30, 2021)
- Estimated cash runway: ~1 year at the moment
- MarzAA burn reduction: ~40% through headcount and CRO cost reductions
Strategy & Ops
- Stop clinical development of MarzAA; focus solely on complement programs and protease medicines platform
- Continue reporting MarzAA data obtained to date; wind-down of trial requires 'a couple of months' due to mandatory safety follow-up and data cleaning before public release
- Shift development candidate cadence: plan to submit IND for CB 4332 in 2022 and initiate first-in-human
- Plan to nominate next development candidate from protein discovery platform in 2022
Market Outlook
- CB 4332 IND submission planned for 2022
- First-in-human trial: single ascending dose followed by multiple ascending dose; data expectation: initial PK data by end of 2022
- MarzAA MAA-304/Crimson-1 completion estimate: late 2023 (not aligned with earlier objective of submission by year-end and pivotal data in 2022)
Risks & Headwinds
- Enrollment challenge for MarzAA: enrollment 'very slow' due to pandemic logistical challenges and increasing competition for study subjects from prophylaxis therapy (approved and late-stage globally)
- Strategic hurdle: long-term DSM-V impacts because last patient requires ~14 months to complete ~10 bleeds; slow enrollment pushed data to latter part of 2023
- MarzAA feasibility/financing constraint: company stated it could not finance through completion based on anticipated timelines/expenses without a partner
- Immunogenicity risk acknowledged for CB 4332: company stated it is conducting a full immunogenicity risk assessment (in silico T-cell epitope/regitope analysis and antigen-presenting cell testing), and management is 'confident' about profile—no observed issues yet in the discussion
- Natural history study recruitment risk/opportunity: reliance on proactive KOL outreach/boots-on-ground to identify CFI-deficient patients for future interventional trial enrollment
Sentiment: CAUTIOUS
Note: This summary was synthesized by AI from the GYRE Q3 2021 earnings transcript. Financial data is complex; please verify all metrics against official SEC filings before making investment decisions.