Carsgen Therapeutics Holdings Ltd. · HKEX:2171
Carsgen Therapeutics — Investor Presentation (October 2026)
54 slides from Carsgen Therapeutics's investor presentation, October 2026
Slide 1: CARsgen Therapeutics (HKEX: 02171)
CARsgen Therapeutics (HKEX: 02171) October 2026 Making Cancer Curable
Slide 2: Disclaimer
Disclaimer THIS DOCUMENT IS FOR INFORMATIONAL PURPOSES ONLY AND IS NOT INTENDED TO BE, AND SHALL NOT BE CONSTRUED AS, AN OFFER, INDUCEMENT, INVITATION, SOLICITATION, COMMITMENT OR ADVERTISEMENT WITH RESPECT TO THE PURCHASE, SUBSCRIPTION OR SALE OF ANY SECURITY AND NO PART OF IT SHALL FORM THE BASIS
Slide 3: CARsgen Develops Differentiated Cell Therapies to Make Cancer Curable
CARsgen Develops Differentiated Cell Therapies to Make Cancer and Other Diseases Curable 12 Years Pioneer in Autologous CAR-T CAR Constructs Focus on innovative CAR-T therapies • Zevor-cel (BCMA CAR-T) – Marketed Potentially best-in-class CAR constructs since company initiation • Satri-cel (Claudin1
Slide 4: Experienced Senior Management Team
Experienced Senior Management Team Zonghai Li, MD, PhD Co-founder, Chairman of the Board, CEO, CSO • Former leader of the biotherapy research team at the State Key Laboratory of Oncogenes and Related Genes of Shanghai Cancer Institute. • Former professor at Shanghai Cancer Institute, Renji Hospital
Slide 5: Global Reach with Integrated R&D and Manufacturing Capabilities
Global Reach with Integrated R&D and Manufacturing Capabilities Complemented with Synergistic Partnership CGMP Facility Beijing Office Headquarter (Xuhui) Shanghai Headquarter, research, clinical development, GMP Durham Beijing commercial and clinical manufacturing facility Shanghai Durham, North Ca
Slide 6: CARsgen Pioneered the Development of CAR-T Against Solid Tumors
CARsgen Pioneered the Development of CAR-T Against Solid Tumors • Published the first paper of GPC3 CAR-T in 2014 and the first clinical trial • Published first paper of claudin18.2 CAR-T in 2018 and initiated the first clinical trial • The first CAR-T against solid tumors: satri-cel (approved in Ch
Slide 7: CAR-T in Combination with Local Therapy Against HCC
CAR-T in Combination with Local Therapy Against HCC: Both Patients Achieved Disease-free Survival around 10 Years • Cover Story in Cancer Communications • Both patients stayed tumor free till latest follow-up on Apr 11, 2025 Based on the favorable efficacy of our prior autologous CAR-T in clinical s
Slide 8: Advancing a Competitive Pipeline with Global Rights
Advancing a Competitive Pipeline with Global Rights Product BLA/ Target Indication Pre-clinical Phase I Phase II/III2 Candidate1 NDA R/R MM (4L+) LUMMICAR 1 (China) On market Zevor-cel (CT053)3 BCMA R/R MM Autologous LUMMICAR 2 (US, Canada) CAR-T G/GEJA (3L+) ST-01 (China) On market GC/PC ST-02 (US,
Slide 9: Autologous CAR-T: Marketed Products in Solid Tumor & Hematologic Malignancies
Autologous CAR-T: Marketed Products in Solid Tumor & Hematologic Malignancies
Slide 10: Unmet Medical Needs in Solid Tumors, Including Gastric and Pancreatic Cancers
Unmet Medical Needs in Solid Tumors, Including Gastric and Pancreatic Cancers Incidence ~27.6K1 Incidence ~342.0K2 Gastric Mortality ~11.1K1 Mortality ~248.7K2 Cancer 5-year survival rate of advanced GC is 5-20%; For advanced GC (3L+), ORR is 4.5%, mPFS < 2 months, mOS < 6 months (TAGS study)3 Pancr
Slide 11: CARsgen Proprietary Claudin18.2 IHC Test
CARsgen Proprietary Claudin18.2 IHC Test • Claudin18.2 IHC test kit with high sensitivity • The kit has been included in the Priority Evaluation and Approval procedure by the NMPA Gastric Cancer Pancreatic Cancer Moderate / high (2+/3+, ≥40%) Moderate / high (2+/3+, ≥40%) Total positivity 67% Total
Slide 12: Satri-cel (CT041): Global First-in-Class CAR-T for Claudin18.2-Positive Solid Tumors
Satri-cel (CT041): Global First-in-Class CAR-T for Claudin18.2- Positive Solid Tumors Product Designations Clinical Development • RMAT (FDA) • Optimized scFv1 • Orphan Drug (FDA) ✓ High binding affinity • Approved by the NMPA in June 2026 for ✓ High stability • Orphan Medicinal Product (EMA) the tre
Slide 13: Satri-cel (CT041) Confirmatory Phase II trial
Satri-cel (CT041) Confirmatory Phase II trial An open-label, multicenter, randomized controlled trial (CT041-ST-01, NCT04581473) was conducted in China. A total of 156 G/GEJC patients with Claudin18.2- positive tumors who had experienced failure of at least second-line treatment were randomized in a
Slide 14: Satri-cel Confirmatory Phase II trial - Baseline & Safety
Satri-cel (CT041) Confirmatory Phase II trial - Baseline & Safety ITT Population（including CT041 TPC Safety Summary patients did not receive） （n=104） （n=52） ≥3 prior lines of treatment 26.9% 19.2% • Only 4（4.5%）3 Grade CRS，no Grade 4-5 CRS • No ICANS Peritoneal Metastasis 69.2% 59.6% • 1 treatment-r
Slide 15: Satri-cel Prolonged mPFS and mOS for Gastric or GEJ Cancer
Satri-cel Prolonged mPFS and mOS for Patients with Gastric or Gastroesophageal Junction Cancer mITT Population（patients mITT Population（patients TPC (including received treatment） Satri-cel TPC received treatment） Satri-cel 20 pts received Cut-off date：Oct 18, 2024 Cut-off date：Mar 18, 2025 Satri-ce
Slide 16: Satri-cel: Consistent Clinical Responses across Three Single Arm Studies
Satri-cel (CT041) : Exhibits Consistent Clinical Responses across Three Single Arm Studies China investigator- Phase Ib in China Phase 1b in the US initiated trial (NCT04581473)3 (NCT04404595)4 (NCT03874897)1,2 SOC in G/GEJA patients who had failed Sample size, No. 51 G/GEJA* 14 G/GEJA 7 G/GEJA 12 P
Slide 17: Satri-cel: Extension to GC/PC Earlier Line / Adjuvant Settings
Satri-cel: Extension to GC/PC Earlier Line / Adjuvant Settings Promising greater clinical value in earlier line / earlier disease stage and providing better chances of cure for a much broader patient population More Accessible Tumor Better Tolerability • Low disease burden & • Mild CRS aggressivenes
Slide 18: Satri-cel as GC 1L Consolidation Delivered 100% ORR
Satri-cel as GC 1L Consolidation Delivered 100% ORR BOR of Satri- No. Age/Gender BOR of 1st line TTR cel Satri-cel Efficacy Highlights 1 50/F SD PR W4 • As of October 18, 2025, the median follow-up 2 55/F PR PR W4 time from initial 1L therapy was 54.6 months • ORR 100% in 4 patients with target lesi
Slide 19: Two GC Patients Underwent Surgical Resection, Remain in Long-term Survival
Following Satri-cel Infusion, Two GC Patients Underwent Surgical Resection, and Remain in Long-term Survival Case 1 Case 2 1L Treatment 1L Treatment • Regimen: POS regimen (6 cycles) + S-1/Paclitaxel/TNF • Regimen: SOX regimen (4 cycles) intraperitoneal perfusion (4 cycles) • BOR : PR • 1L BOR : SD
Slide 20: Satri-cel in Adjuvant Therapy for Pancreatic Cancer Leads to CA19-9 Decline
Satri-cel in Adjuvant Therapy for Pancreatic Cancer Leads to Significant Decline in CA19-9 Levels As of April 11, 2025 (data cut-off date), 6 PC patients with median follow-up of 6.05 months: 9-month DFS mDFS, mOS rate from not reached surgery 83.3% • Significant decline in CA19-9 levels post infusi
Slide 21: Next-Gen CAR-T Development: Tackling Key Challenges in Solid Tumors
Next-Gen CAR-T Development: Tackling Key Challenges in Solid Tumors Next-gen Claudin18.2 CAR-T shows enhanced anti- Next-gen NKG2DL CAR-T shows robust anti-tumor tumor activity in GC models activity in HCC models Satri-cel-derived Armored CAR-T demonstrates Proprietary CAR-NKG2DL T cells achieve 100
Slide 22: Zevor-cel: Fully-human BCMA CAR-T for R/R MM
Zevor-cel: Fully-human BCMA CAR-T for R/R MM
Slide 23: Zevor-cel: Differentiated Fully-human BCMA CAR-T, Marketed in China
Zevor-cel: Differentiated Fully-human BCMA CAR-T for R/R MM, Marketed in China Zevor-cel Highlights Designations • Breakthrough Therapy (NMPA) • Optimized scFv • RMAT (FDA) • Enhanced binding affinity • Orphan Drug (FDA) • High stability • Enhanced anti-tumor activity • Excellent safety profile Coll
Slide 24: Zevor-cel Commercialization in China Delivers Strong Results
Zevor-cel Commercialization in China Delivers Strong Results Orders of Zevor-cel • Zevor-cel was approved by the NMPA in 2024 • Full year 2024: 154 confirmed orders. for the treatment of R/R MM. • Full year 2025: 218 confirmed orders. • Zevor-cel was included in China’s Commercial • H1, 2026: 110 co
Slide 25: Zevor-cel Pivotal Phase II Study: Responses Continue to Deepen
Zevor-cel Pivotal Phase II Study: Responses Continue to Deepen with Longer Follow-up Response Response with Extended Follow-up CR/sCR 100% ORR：92.2% 100% CR/sCR ≥VGPR VGPR 90% 80% PR 80% Response Rate 70% 60% 60% 50% 71.6% ORR 40% ≥VGPR: 30% 40% 91.2% 20% 10% 0% 20% M3 M6 M9 M14.9 M20.3 CR/sCR 28.30
Slide 26: Subgroup Analysis of IIT and Phase I Study
Subgroup Analysis of IIT and Phase I Study: Competitive Efficacy Even in Patients with Unfavorable Baseline Features ISS-Ⅲ HR-Cyto EMD 100% ORR：81.8% ORR：96.3% ORR：84.2% ORR：100% 100% ORR：91.7% ORR：92.3% 100% 80% 80% 80% Response rate (%) Response rate (%) Response rate (%) sCR/CR： sCR/CR： 60% sCR/C
Slide 27: Zevor-cel Achieves 92.9% 3-Year OS Rate
Zevor-cel Achieves 92.9% 3-Year OS Rate, a Global Leading Outcome Among Its Class Long-Term OS Long-Term PFS 2-year OS rate 3-year OS rate 100%（n=14） 92.9%（n=13） Extended data from the Phase I study showed 3-year OS mPFS: 25 months in the overall population, and 26.9 rate of 92.9%; mOS not reached (
Slide 28: THANK-u Plus: Potential Best-in-Class Allogeneic CAR-T Platform
THANK-u Plus®: Potential Best-in- Class Allogeneic CAR-T Platform
Slide 29: THANK-u Plus: Innovative Allogeneic CAR-T Platform
THANK-u Plus®: Innovative Allogeneic CAR-T Platform Rationale Target and Hinder the Attack of NK cells on Universal CAR-T cells (THANK-uCAR®) Classic strategy to reduce GvHD and HvGR includes disruption of TCR (TRCA) and HLA-I (B2M). However, HvGR still remains a challenge. “Self-missing”- NK cell d
Slide 30: CT0596: Allogeneic BCMA-Targeted CAR-T
CT0596: Allogeneic BCMA-Targeted CAR-T CT0596 • Based on THANK-u Plus®, CT0596—an allogeneic BCMA-targeted CAR-T therapy— was developed for the treatment of R/R MM or PCL. Clinical Development • CT0596 is under evaluation in an IIT for the treatment of R/R MM or PCL. • NMPA IND clearance received in
Slide 31: Benchmark in R/R MM: Approved Autologous CAR T Cells
Benchmark in R/R MM: Approved Autologous CAR T Cells The efficacy data of approved autologous CAR-T cells show a CR rate ranging from 33% to 83.2% and an mPFS of 8.8 to 34.9 months. Zevor-cel1 Ide-cel2 Cilta-cel3 Eque-cel4 71.6% ≥CR, mPFS not Efficacy in 33% ≥CR w/ 83% sCR w/ 83.2% ≥CR w/ mature aft
Slide 32: Benchmark in R/R MM: Allogeneic CAR T Cells
Benchmark in R/R MM: Allogeneic CAR T Cells At the recommended dose, CT0596 achieved a CR rate of 75%, with the mPFS not yet mature. This CR rate is comparable to the efficacy data of approved autologous CAR-T cells, positioning it among the top-tier allogeneic CAR-T therapies globally. The DoR rema
Slide 33: CT0596: Patient Baseline Characteristics
CT0596: Patient Baseline Characteristics 4.5×10⁸ Dose Group Patients (N=8) Primary Diagnosis R/R MM, n (%) 6 (75.0%) R/R pPCL, n (%) 2 (25.0%) Immunoglobulin Type, n (%) IgG 3 (37.5%) IgA 2 (25.0%) κ Light Chain 3 (37.5%) Median age 64.5 Extramedullary Disease, n (%) 1 (12.5%) Median Prior Lines of
Slide 34: CT0596: Manageable Safety
CT0596: Manageable Safety 4.5×10⁸ Dose Group Patients（N=8） Treatment-emergent Adverse Events (TEAE) 8 (100) Cytokine release syndrome (CRS) 7 (87.5) Grade ≥3 CRS 0 IEC-HS 1 (12.5) Immune Effector Cell-associated Neurotoxicity 0 Syndrome (ICANS) Graft-Versus-Host Disease (GVHD) 0 Grade ≥3 Hematologic
Slide 35: CT0596: Deep and Durable Responses
CT0596: Deep and Durable Responses Patients (N=8) ORR, n (%), (95% CI) 8 (100) (63.1, 100) sCR 6 (75.0) VGPR 1 (12.5) PR 1 (12.5) CR/sCR, n (%) 6 (75.0) ≥VGPR, n (%) 7 (87.5) • MRD negativity: All patients attained MRD negativity at a sensitivity of 10⁻⁶ at 4 weeks after the effective infusion • One
Slide 36: CT0596: Robust and Persistent Expansion
CT0596: Robust and Persistent Expansion PK Parameters Patients (N=8) Median Cmax (copies/ug gDNA) 100,078 Median Tmax (day) 10.5 Median AUC0-t (day×copies/ug 732,105 gDNA) • The median Cmax of CT0596 reached the 10⁵ level, which is comparable to that of approved autologous BCMA CAR-T products (10⁴–1
Slide 37: CT1190B: Allogeneic CD19/CD20-Targeting CAR-T Cell Therapy
CT1190B: An Allogeneic CD19/CD20-Targeting CAR-T Cell Therapy CT1190B • Based on the THANK-u Plus® platform, the allogeneic CD19/CD20 -targeting CAR-T product CT1190B has been developed for the treatment of B-cell malignancies. Clinical Development Progress and Plans • An Investigator-Initiated Tria
Slide 38: Benchmark in LBCL: Approved Autologous CAR T Cells
Benchmark in LBCL: Approved Autologous CAR T Cells CT1190B report a 71.4% CR w/ estimated mPFS of around 7 months, comparable to that in approved autologous CAR T-cell product (i.e., 39~54% CR w/ mPFS of 2.9 ~ 7 months) CT1190B1 Tisa-cel2 Axi-cel3 Liso-cel4 Relma-cel5 71.4%* CR w/ Efficacy in 39% CR
Slide 39: Benchmark in LBCL: Allogeneic CAR T Cells
Benchmark in LBCL: Allogeneic CAR T Cells HvGR remains a significant challenge. Even with intensified lymphodepletion and IL-2 support for CAR-T engraftment, most allogeneic CAR-T therapies have demonstrated limited efficacy in 3L+ LBCL, and better approaches to counter rejection are yet to be explo
Slide 40: CT1190B: Patient Baseline Characteristics
CT1190B: Patient Baseline Characteristics Indicators Patients (N=13) Primary Diagnosis LBCL, n (%) 10 (76.9%) FL, n (%) 3 (23.1%) The enrolled patients were heavily pretreated, with a Dose of cells median LOT of 3, including: 1.5×10⁸ 1 • 1pt with prior CD20/CD3 T cell engager 3.0×10⁸ 2 • 1 pt experi
Slide 41: CT1190B: Manageable Safety
CT1190B: Manageable Safety Patients (N=13) Grade ≥3 Infections 0 Cytokine release syndrome (CRS) 8 (61.5) Grade 1~2 7 (53.8) Grade ≥3 1 (7.7) Immune Effector Cell-associated Neurotoxicity 2 (15.4) Syndrome (ICANS) Grade 1~2 1 (7.7) Grade ≥3 1 (7.7) AE leading to death 0 AE leading to study discontin
Slide 42: CT1190B: Durable Efficacy
CT1190B: Durable Efficacy Objective Response Complete N(%) Response N(%) Dose Group 1.5×108（N=1） 0 0 3.0×108（N=2） 2（100） 1（50.0） 4.5×108（N=4） 4（100） 3（75.0） 6.0×108（N=5） 5（100） 4（80.0） NHL Subtype Group FL(N=3) Regimen B（N=3） 3（100） 3（100） Regimen B（N=2） 1（50.0） 0 LBCL (N=9） Regimen A（N=7） 7（100） 5（
Slide 43: CT1190B: Robust Expansion across Intermediate or Higher Doses
CT1190B: Robust Expansion across Intermediate or Higher Doses Median Cmax Median AUC0-t (Copies/ug gDNA） (Days×Copies/ug gDNA) Cell Dose 6.0×108 117863.0 643903.5 （N=6） Lymphodepletion 77903.0 575650.3 Regimen A（N=8） Note: Regimen A: F: 30mg/m2 × 3d; C: 1000mg/m2 × 2d • In the highest dose group (6.
Slide 44: CARvivo: Potential Best-in-Class Lentiviral Vector in vivo CAR-T Platform
CARvivo : Potential Best-in-Class Lentiviral Vector in vivo CAR-T Platform
Slide 45: CARvivo: a Potential Best-in-class in vivo CAR Platform
CARvivo : a Potential Best-in-class in vivo CAR Platform ---Upgraded mutated Advantages of CARvivo : viral envelope 1. Proprietary fusogen engineered for enhanced fusogenic ---Rationally designed redirected capacity targeting molecules 2. Superior transduction efficiency 3. High specificity for T-ce
Slide 46: CARpro: Proprietary T Cell-Specific Promoter
CARpro: CARsgen’s Proprietary T Cell–Specific Promoter with Superior Specificity and Comparable Potency CAR expression in primary T-cell CAR MFI in primary T-cell 60 1500 Blank Blank no promoter no promoter 40 EF1A 1000 EF1A CAR% Benchmark promoter MFI Benchmark promoter CARpro CARpro 20 500 0 0 don
Slide 47: CARvivo Lentiviral Vector Displayed Superior T Cell Transduction Specificity
CARsgen’s Proprietary CARvivo Lentiviral Vector Displayed Superior T Cell Transduction Specificity A MM.1S B Nalm6 100 100 CARvivoTM LV CARvivoTM LV Benchmark LV 80 80 Benchmark LV Standard VSVG LV Standard VSVG LV 60 60 CAR% CAR% 40 40 20 20 0 0 2E5 4E4 1E4 2E3 2E5 4E4 1E4 2E3 MOI MOI C 100 K562 D
Slide 48: CARvivo LV with Superior T Cell Transduction Efficiency and Expansion
CARvivo LV with Superior T Cell Transduction Efficiency and CAR-T cell expansion CAR expression in PBMC (D4) CAR expression in PBMC (D7) CAR-T cell counts (D7) 25 50 Blank 4×10 5 Blank Blank Benchmark LV Benchmark LV 3×10 5 20 Benchmark LV 40 CARvivoTM LV 2×10 5 CARvivoTM LV TM Cell counts CARvivo L
Slide 49: KJ-C2529 Incorporates a Potential Best-in-Class CD19/CD20 CAR
KJ-C2529 Incorporates a Potential Best-in-Class CD19/CD20 CAR uUTD uCD19 x x x xx x xx x xx x xx x x x x x uCD20 xx xxx xxx xxx uCD19/20 (Benchmark) x x x x x x x uCD19/20 (CARsgen) • Benchmark CD19/CD20 dual-target CAR-T was constructed based on Patent: US11207349B2 (Abelzeta Pharma). • CARsgen’s C
Slide 50: CARvivo LV (CD19/CD20) Showed Enhanced Tumor Inhibition
CARvivo LV (CD19/CD20) Showed Enhanced Tumor Inhibition and CAR-T Cell Generation in MHC I/II DKO NPG Mice Nalm6-Luci PBMC Virus A tumor cell i.v. i.v. End of experiment D0 D5 D6 D28 MHC I/II DKO NPG mice CARvivoTM LV CARvivoTM LV Benchmark LV Benchmark LV Vehicle C Nalm6-luci B high low high low 10
Slide 51: CARvivo LV (CD19/CD20) Demonstrated Potent Antitumor Effect at Very Low Dose
CARvivo LV (CD19/CD20) Demonstrated Potent Antitumor Effect in NPG Mice, even at Very Low Dose Nalm6-Luci tumor cell PBMC i.v. virus i.v. End of experiment D0 D5 D6 D28 NPG mice Vehicle 7e5 TU/mouse 3.5e5 TU/mouse D5 D17 D23 D28 • Both 3.5×10⁵ and 7×10⁵ dose levels of in vivo CD19/CD20 product candi
Slide 52: Upcoming Value Inflection Milestones
Upcoming Value Inflection Milestones Commercialization: Continue to drive the commercialization of zevor-cel and satri-cel. Satri-cel: IIT data from adjuvant therapy of gastric cancer expected to be updated at ESMO 2026. CT1190B: IIT data expected to be updated at ASH 2026. Phase I clinical
Slide 53: Financial Highlights
Financial Highlights H1, 2026 Revenue Cash and cash equivalents and deposits at the end of 2026 are RMB62 million expected to be ✓ Revenue for the H1 2026 was primarily derived from zevor- ≥RMB 1.2 billion cel. Satri-cel, which was launched in June this year, will contribute revenue in the H2. Selli
Slide 54: Making Cancer Curable
Making Cancer Curable oS cARSGEN
CARsgen Therapeutics — Investor Presentation (October 2026) on 6ix