Gyre Therapeutics, Inc. · NASDAQ:GYRE
Gyre Therapeutics — Merger or Acquisition (March 2026)
39 slides from Gyre Therapeutics's merger presentation, Mar 2, 2026
Slide 1: A Fully-Integrated Biopharmaceutical Company Featuring a Robust Pipeline of Degraders and DACs
A Fully-Integrated Biopharmaceutical Company Featuring a Robust Pipeline of Degraders and DACs
Slide 2: Forward-looking statements
This presentation contains “forward-looking statements” within the meaning of the federal securities laws, including Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, regarding the current plans, expectations and
Slide 3: Gyre Therapeutics: At-A-Glance
Gyre Therapeutics: At-A-Glance
Slide 4: Cullgen: At-A-Glance
A Targeted Protein Degrader Company: Founded in 2018 >120 employees worldwide ~50% with advanced degrees (PhD, MD, JD, MBA, MS) 8 Announced therapeutic programs: 1 forthcoming Phase 2 clinical trial 2 currently in Phase 1 clinical trials 2 IND-enabling studies 2 DACs in lead optimization 1 degrader
Slide 5: A Powerful Combination
Cullgen Inc. Combined entity intends to leverage established and cost-efficient China operations for accelerated discovery, early validation, and development of next generation therapeutics based on degraders and DACs San Diego, CA Corporate HQ - G&A, Clinical Development Shanghai, China Drug Discov
Slide 6: Post-Combination Gyre Therapeutics: At-A-Glance
Post-Combination Gyre Therapeutics: At-A-Glance Expected Date of Close Early Q2 2026 Company Name Gyre Therapeutics, Inc. (Nasdaq: GYRE) Company Headquarters San Diego, CA, with subsidiaries in Beijing and Shanghai Post-Merger Leadership Ying Luo – President & CEO Yue Xiong – CSO Ping Zhang – Execut
Slide 7: Key Value Drivers
Key Value Drivers 2 3 1 Robust and balanced therapeutic pipeline including assets from discovery to development, with established manufacturing and commercialization operations 4 Utilization of highly efficient and cost-effective drug discovery capabilities in China to advance risk-mitigated product
Slide 8: Broad Product Portfolio from Discovery to Commercialization
Broad Product Portfolio from Discovery to Commercialization
Slide 9: Robust Portfolio: Addressing Inflammatory Diseases, Pain and Cancer
Key: Inflammation / Fibrosis / Pain Cancer Robust Portfolio: Addressing Inflammatory Diseases, Pain and Cancer Discovery / Lead Optimization IND Enabling Phase 1a Phase 1b/2 Pre-NDA Marketed ETUARY® (Pirfenidone) Idiopathic Pulmonary Fibrosis (IPF) F528 Chronic Obstructive Pulmonary Disease (COPD) C
Slide 10: Therapeutic Pipeline: Significant Focus on DACs & Degraders
Program and Description Discovery IND Enabling Phase 1a Phase 1b/2 Phase 3 Indication DAC | Epigenetic Factor Undisclosed Target Prostate, lung & bladder cancers Degrader | TRK CG001419 Acute and chronic pain Degrader | TRK CG001419 Solid tumors Degrader | GSPT1 CG009301 Leukemia and MYC+ cancers De
Slide 11: TPD and DAC Platform Technology to Revolutionize Drug Discovery
TPD and DAC Platform Technology to Revolutionize Drug Discovery
Slide 12: Hijacking the Ubiquitin Proteasome System to Target Undruggable Proteins
Targeted protein degraders are bi-functional molecules that bind to disease causing proteins and specific E3 ligases inside cells Targeted protein degrader binds to disease causing protein and recruits E3 ligase to begin the ubiquitination process Multiple ubiquitin molecules ”tag” disease causing p
Slide 13: Degrader-Antibody Conjugates Represent the Next Generation of ADCs
Degrader-Antibody Conjugates (DACs) Combine the Advantages of ADCs and TPD and Represent the Next-Generation of ADCs ADC (Antibody drug conjugate) DAC (Degrader antibody conjugate) TPD (Targeted protein degradation) E3 ligase E3 ligase Reduced toxicity through dual target selectivity at the cell sur
Slide 14: Targeted Protein Degraders and DACs Expand Druggable Disease Space
Disease Causing Protein 1. Santos et al. (2017) Nat Rev Drug Discov PMID: 27910877 Cullgen’s targeted protein degraders and degrader-antibody conjugates (DACs) allow access to potentially all disease-causing proteins. ~37% Target Accessibility Up to 100% Target Accessibility DAC Degrader Small Molec
Slide 15: Prostate Cancer DAC Induces Target Degradation and Kills Cancer Cells
Cell Line TAA Positive Cell Line Compounds (nM） DMSO Degrader DAC DMSO Linker-degrader DMSO 0.01 0.1 1 10 100 0.01 0.1 1 10 100 0.01 0.1 1 10 100 Lane 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Cell Line TAA Negative Cell Line Compounds (nM） DMSO Degrader DAC DMSO Linker- degrader mAb DMSO 0.01 0.
Slide 16: Prostate Cancer DAC Demonstrates Durable Tumor Growth Inhibition
Cullgen’s Prostate Cancer DAC Demonstrates Durable Tumor Growth Inhibition and Overcomes Resistance to Current Therapy MDA-Pca-2b (CDX) B. DAC synergizes with the standard-of-care (SOC) agent C. DACs overcome therapy-resistance in CPRC PDX A. DAC demonstrates durable tumor growth inhibition in vivo
Slide 17: Leading Inflammation/Fibrosis Therapeutic Programs
Leading Inflammation/Fibrosis Therapeutic ProgramsExpanding F351’s Global Market PotentialTyk2 for Rheumatoid Diseases
Slide 18: F351 Overview
F351 Overview Product: F351 - Hydronidone Primary Indication Liver fibrosis - Chronic Hepatitis B (CHB) / Metabolic dysfunction-Associated SteatoHepatitis (MASH) Summary A structural analogue of pirfenidone, chemically modified to reduce metabolism liabilities. Anti-fibrotic with TGF-β1 targeting me
Slide 19: F351 Phase 3 Results
Primary Endpoint Met with High Statistical Significance Key Secondary Endpoint Reduction in Liver Inflammation Favorable Safety Profile ≥1-stage fibrosis regression at Week 52: Hydronidone: 52.85% (n=123) vs. Placebo: 29.84% (n=124) Delta: 23.01% P = 0.0002 (ITT1 analysis with central blinded pathol
Slide 20: Exploring F351's Potential in the U.S.
Exploring F351’s Potential in CHB-related and/or MASH-related Compensated Liver Fibrosis and Cirrhosis in the U.S. Note: Market projections based on epidemiological research report prepared by L.E.K. Consulting for Gyre on 12-18-2025
Slide 21: Dual Targeting of TYK2 and JAK1 for Autoimmune Diseases
A. TYK2/JAK- STAT signaling Tsokos GC.(2011) NEJM PMID: 22129255 McInnes & Schett (2011) NEJM PMID: 22150039 B. SLE Mechanism C. RA Mechanism Platanias, LC. (2005) Nat Rev Immunol PMID:15864272 Significant Opportunity 125,000,000 psoriasis patients worldwide1 18,000,000 rheumatoid arthritis patients
Slide 22: TYK2-JAK1 Dual Degrader Superior Efficacy in Preclinical Models
TYK2-JAK1 Dual Degrader Demonstrates Superior Efficacy in Preclinical Models for Lupus And Rheumatoid Arthritis
Slide 23: Pain Therapeutic Program CG001419 for Acute and Chronic Pain
Pain Therapeutic Program CG001419 for Acute and Chronic Pain
Slide 24: Opioid Crisis Created an Urgent Unmet Medical Need
A. Only one non-NSAID non-opiate analgesic has been approved in the last 25 years for acute pain B. Chronic and Acute Pain Management is a multi-billion-dollar market 2000 2005 2010 2015 2020 2025 Meloxicam NSAID 2000 Diclofenac potassium soft gelatin NSAID 2009 Tapentadol Opiate 2008 Bupivicaine li
Slide 25: The Role for TRKA in Nociception Validated in Humans
A. Nerve growth factor (NGF) stimulates the TrkA signaling pathway to transmit pain to the central nervous system TrkA Dorsal root ganglion (DRG) NGF Injury / Inflammation Brain NGF-TRKA complex Lane et al. (2010) NEJM PMID: 20942668 C. Blocking NGF reduces osteoarthritis pain B. TRKA mutations caus
Slide 26: Clinical Development of CG001419 for Acute Post-Operative Pain
Phase 1a Dose Escalation, IND Enabling Key Findings from Phase 1 Study All dose regimens were well tolerated Plasma levels are consistent with DC50 and DC90 levels from preclinical studies Results provide sufficient guidance for appropriate dosing levels to evaluate in the phase 2 bunionectomy study
Slide 27: Summary of Phase 1 PD, PK and Safety Study of CG001419
Summary of Phase 1 PD, PK and Safety Study of CG001419 CG001419-101 (NCT06636500): a SAD/MAD/FE study in healthy subjects in Australia The surrogate PD assay demonstrated DC50 and DC90 values of 2.4 nM and 18.2 nM, respectively Single and multiple oral doses of CG001419 up to the highest dosing leve
Slide 28: Phase 1b/2a Acute Pain Bunionectomy Study
* Subject to regulatory alignment Phase 1b/2a Acute Pain Bunionectomy Study* Part A: Dose regimen evaluation to select dose for Part C Part B (Optional): Dose expansion to inform power calculations and size for Part C Part C: Powered efficacy portion of study Primary Endpoint: SPI48 (time-weighted s
Slide 29: CG001419: Differentiated Potential First in Class Non-Opioid Medicine
CG001419: Differentiated as a Potential First in Class Non-Opioid Medicine for the Treatment of Pain Opioids NSAIDs Cebranopadol Journavx (Suzetrigine, VX-548) VX-993 LTG-001 STC-004 CG001419 Safety Concerns Risk to develop dependency GI issues, headache, dizziness Nausea - - - - - Effective Moder
Slide 30: Cancer Programs
Cancer ProgramsCG001419: for pan-TRK Cancers CG009301: GSPT1 Degrader for AML and MYC+ Cancers
Slide 31: TRKs Are Receptors for Neurotrophins Including NGF
Cocco, Scaltriti & Drilon (2018) Nat Rev Clin Oncol PMID: 30333516 B. Activation of TRK in multiple solid tumors A. TRK signaling pathways Tropomyosin Receptor Kinases (TRKs) Are Receptors for Neurotrophins Including NGF
Slide 32: Clinical Development of CG001419 for Cancer
Future Data Points Data from first 18 patients demonstrated no observed DLTs, treatment-related SAEs or grade ≥3 treatment related AEs. Enrollment to dose expansion portions is anticipated to begin Q1 2026. RDE Phase 1a Dose Escalation 1b Dose Expansion Phase 2 Basket Trial Dose level 1, n =3~6 Dose
Slide 33: CG009301 Targeting GSPT1 for AML and MYC+ Cancers
GSPT1 controls protein translation termination and plays important function for leukemia stem cells and tumor cells with MYC overproduction. GSPT1 lacks an active site and is often considered “undruggable”. Cullgen has developed a potent and selective GSPT1 degrader, CG009301. Preclinical studies ha
Slide 34: Clinical Development of CG009301 in Hematologic Malignancies
Dose Escalation Stage Dose Expansion Stage* Dose level 1, n =1 Dose level 2, n=1 Dose level 3, n=3~6 Dose level 6, n=6~12 Dose level 7, n=6~12 BOIN Design Dose #1, n=9~18 Dose #2, n=9~18 Dose level 4, n=3~6 Dose level 5, n=3~6 Accelerated Titration Phase 2* R/R AML or HR-MDS or R/R ALL RDE Dose leve
Slide 35: Anticipated Upcoming Catalysts
Anticipated Upcoming Catalysts Q1-2027 IND submission of Phase I trial of CG620953 for inflammatory diseases in China 2H-2027 Completion of the Phase I trial of CG009301 for AML in China Q1-2027 IND submission of Phase I trial of CG923308 for cancer in the U.S. and China Q1-2027 IND submission of Ph
Slide 36: Investment Summary: Gyre's Acquisition of Cullgen
Investment Summary: Gyre’s Acquisition of Cullgen 2 3 1 Robust and balanced therapeutic pipeline including assets from discovery to development, with established manufacturing and commercialization operations 4 Utilization of highly efficient and cost-effective drug discovery capabilities in China t
Slide 37: Future Board of Combined Company
Future Board of Combined Company Ping Zhang, MBA Executive Chairman 20 years experience in healthcare investment with senior postings in Japan and China. Managing director of String Capital. Executive director of GNI Group Ltd. Renate Parry, PhD 25 years of research experience in global pharma. Deve
Slide 38: Future Leadership Team of Combined Company
Ying Luo, PhDPresident and CEO >30 years of biotech experience. PhD from U. CT. President of GNI Group. Founded Shanghai Genomics and led GNI IPO (TSE 2160). Responsible for 6 IND approvals and 1 class 1 drug approval (Etuary) by China FDA. Author of >37 research articles and >20 patents. Yue Xiong,
Slide 39: Thank You
Thank Thank You
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