NovaBridge Biosciences · NASDAQ:NBP
NovaBridge Biosciences — I-Mab — Investor Presentation (July 2025)
38 slides from NovaBridge Biosciences's investor presentation, Jul 2, 2025
Slide 1: Transforming Potential into Reality
Transforming Potential into Reality I-Mab Biopharma July 2025
Slide 2: Legal Disclaimer
Legal Disclaimer. This presentation has been prepared by I-Mab (the “Company”) solely for informational purposes. Certain of the information included herein was obtained from various sources, including certain third parties, and has not been independently verified by the Company. By viewing or acces
Slide 3: Taking a Step Beyond Traditional Early Drug Development
Asset PHASE 1 PHASE 2 PHASE 3 INDICATIONS PARTNERSHIPS Givastomig1 CLDN18.2 X 4-1BB Bispecific Ab 1L GC, GEJ, EAC: Target population of ~137k patients2 Ragistomig1 PD-L1 X 4-1BB Bispecific Ab Refractory/relapsed cancers: PD-(L)1 progression impacts most patients with metastatic disease Uliledlimab C
Slide 4: Advancing Givastomig, A Potential Best-in-Class CLDN18.2 Asset
Advancing Givastomig, A Potential Best-in-Class, Blockbuster CLDN18.2 Asset Potential Best-in-Class CLDN18.2 Therapeutic for Gastric Cancer Advancing givastomig, a novel bispecific, CLDN18.2 x 4-1BB Clinical data to date has shown anti-tumor activity with limited toxicities Clinical activity observe
Slide 5: Significant Unmet Need in Gastric Cancer with Limited Treatment Options
5th most common cancer with ~250k patients globally and 4th leading cause of cancer mortality worldwide1 Over 60% of patients are diagnosed at an advanced or metastatic stage2, where prognosis is poor Despite approved therapies, 5-year survival rates are only ~7%2 Growing market with $12Bn in sales
Slide 6: Zolbetuximab: First Approved CLDN18.2 mAb for Gastric Cancer
Zolbetuximab: First Approved CLDN18.2 mAb for Gastric Cancer Distribution of Claudin 18.2 Expression in Over 4,000 Gastric Cancer Patients Opportunity to expand and outperform other CLDN18.2 directed therapies1 Limited to subset of CLDN18.2-positivity ((IHC 2+ or 3+) ≥75%)2 Approved with chemotherap
Slide 7: Expected Upcoming Clinical Readouts Across Portfolio Programs
Cash, cash equivalents and short-term investments as of March 31, 2025, were $168.6M; no debt Cash position expected to fund givastomig Phase 1b studies and further development initiatives into 2027 Issued and outstanding ordinary shares of 187.8M representing the equivalent of 81.7M ADSs1 as of Mar
Slide 8: Lead Program, Givastomig (Targeting Claudin 18.2 and 4-1BB)
First asset to be tested in US with immuno-chemotherapy standard of care in 1L gastric cancer Molecular Design Key Differentiation Clinical activity observed across various levels of CLDN18.2 expression Exhibits CLDN18.2 binding even on low expressing tumor cells Higher-affinity binding to CLDN18.2
Slide 9: Givastomig, a Bispecific Antibody Targeting Claudin 18.2 and 4-1BB
Conditional T Cell Activation Upon Tumor Engagement In Circulation Tumor Microenvironment Anti-CLDN18.2 IgG1 Anti-4-1BB scFv Highly potent CLDN18.2 mAb Higher affinity than zolbetuximab Binds to tumor cells with a wide range of CLDN18.2 expression Silenced Fc: IgG1 (N297A) No ADCC or CDC Designed to
Slide 10: Comparison of Claudin 18.2-targeted Therapeutics Mechanisms of Action
1 4 3 2 Antibody-Drug Conjugate (AZD0901) Tumor killing by cytotoxicity, bystander killing, ADCC, ADCP, and CDC High risk of on-target GI toxicity & off-target systemic toxicity Bispecific CD3 T Cell Engager (IBI389) Tumor killing by TDCC and bystander killing via engagement of TCR co-receptor High
Slide 11: Givastomig Efficacy Across Broader Claudin 18.2 Expression
Givastomig Efficacy Across Broader Claudin 18.2 Expression Drug Givastomig (bispecific) Zolbetuximab (CLDN18.2 targeted mAb) Phase Phase 1 Phase 1 Phase 2 CLDN18.2 Expression (Study Group) IHC ≥1+ in ≥1% cells IHC ≥1+ in ≥1% cells IHC ≥ 2+ in ≥ 50% cells Diagnosis Previously treated GC/GEJ/EAC Previ
Slide 12: Differentiation of Givastomig from Other Claudin 18.2 Targeted Competitors
Differentiation of Givastomig from Other Claudin 18.2 Targeted Competitors Phase 1 Monotherapy Data Givastomig (bispecific) (n=45, updated from ESMO 2024) Zolbetuximab (mAb)1 (n=54 safety; n=43 efficacy) CMG901 (ADC)2 (n=107) IBI389 (TCE)3 (n=120) Mechanism of Action Conditional 4-1BB activation ADC
Slide 13: Phase 1b Study Design of Givastomig Combined with Immuno-chemotherapy
Endpoints: Primary: Safety Secondary: Response rate: ORR, BoR, DoR Survival: PFS, OS PK/PD Notes: GC = gastric cancer; GEJ = gastroesophageal junction; EAC = esophageal adenocarcinoma; mFOLFOX6 = standard of care chemotherapy regimen; nivo = nivolumab; Q2W = every two weeks; Giva = givastomig; MAD/M
Slide 14: Dose Escalation Baseline Patient Characteristics
Dose Escalation Baseline Patient Characteristics Feature(s) 5 mg/kg (n=5) 8 mg/kg (n=6) 12 mg/kg (n=6) Total (n=17) Age Median (range) 45 54 57 56 (41, 65) (35, 69) (43, 79) (35, 79) Gender Female 3 (60%) 4 (67%) 5 (83%) 12 (71%) Male 2 (40%) 2 (33%) 1 (17%) 5 (29%) Race White 5 (100%) 3 (50%) 3 (50
Slide 15: Givastomig + Nivolumab + mFOLFOX6 Achieved an ORR of 71%
Givastomig + Nivolumab + mFOLFOX6 Achieved an ORR of 71% Across Range of PD-L1 & CLDN18.2 Expression Biomarker ORR: % (n) All Escalation (n=17) Expansion Cohorts (8 & 12 mg/kg) (n=12) Total 71 (12/17) 83 (10/12) PD-L1 ≥ 5 82 (9/11) 89 (8/9) < 5 50 (3/6) 67 (2/3) ≥ 1 73 (11/15) 82 (9/11) < 1 50 (1/2)
Slide 16: Combination Therapy Demonstrated Rapid, Deep, and Durable Responses
Combination Therapy Demonstrated Rapid, Deep, and Durable Responses All patients had a decrease in target lesions at the first follow-up scan 6 out of 6 patients at the 12 mg/kg dose level had deeper responses from the second to third follow-up scan Notes: Data cutoff as of May 15, 2025
Slide 17: Responses Continue to Mature but Highlight Potential for Long-Term Efficacy
Givastomig + Nivolumab + mFOLFOX6 Responses Continue to Mature but Highlight Potential for Long-Term Efficacy CPS CLDN Median follow-up of 9.0 months across all dose levels Estimated 6-month PFS rate of 82% for 8 mg/kg and 12 mg/kg cohorts (n=12) and 73% for all patients (n=17) One patient at 5 mg/k
Slide 18: PK and PD Profiles in Combination Escalation Cohorts
PK and PD Profiles in Combination Escalation Cohorts Givastomig PK profile in combination therapy was similar to that in monotherapy PD Effect on Peripheral Soluble 4-1BB at C1D15 Exposure of givastomig observed to increase in an approximately dose-proportional manner (at doses ≥ 5 mg/kg); with half
Slide 19: Givastomig Well Tolerated in Combination with Immuno-chemotherapy
Givastomig Well Tolerated in Combination with Immuno-chemotherapy No dose limiting toxicity was observed 5 mg/kg (n=5) (%) 8 mg/kg (n=6) (%) 12 mg/kg (n=6) (%) Total (n=17) (%) TEAE 100% 100% 100% 100% TRAE giva 80% 83% 100% 88% TRAE any drug 100% 100% 100% 100% SAE 60% 67% 17% 47% Related SAE giva
Slide 20: Givastomig Dose Escalation Safety Compared to CheckMate-649 and SPOTLIGHT
Givastomig Dose Escalation (n=17) CHECKMATE-6491 (n=1,549) SPOTLIGHT2 (n=557) Givastomig (All doses) Escalation Combo (n=17) Givastomig (8 mg/kg + 12 mg/kg) Escalation Combo (n=12) mFOLFOX6 / CapeOX (n=767) mFOLFOX6 / CapeOX + Nivo (n=782) mFOLFOX6 (n=278) mFOLFOX6 + Zolbe (n=279) AST increased All
Slide 21: Givastomig Potentially FIC & BIC: Claudin 18.2 Gastric Cancer Market Opportunity
Givastomig Potentially FIC & BIC Givastomig Potentially BIC Zolbetuximab4 Gastric Cancer HER2-negative2 CLDN18.2-positive3 250k 195k 137k PD-L1 CPS CLDN18.2 Level 100% >75% >1% 1L HER2-negative Gastric Cancer Therapeutic Landscape Claudin 18.2 Gastric Cancer Market Opportunity Approximately 250,000
Slide 22: Significant Opportunity for Claudin 18.2 Asset Class Beyond Gastric Cancer
Markets include U.S., 5 E.U., and Japan by 2030 based on Data Monitor Biomed Tracker Pancreatic Cancer Market Size, Share, and Trends 2024 to 2034 Olympus Research Global and Wall Street Equity Research Represents CLDN18.2 prevalence within population; Ventana Assay Validation Report on file Ventana
Slide 23: Intellectual Property Portfolio for Givastomig
Intellectual Property Portfolio for Givastomig 2037 2038 2039 2040 2041 2042 2043 2044 2045 2046 US 17/286,437 (Granted) Composition of Matter / Method of Use Treatment of Cancer Aug-2040 US 18/866,687 (Pending)1 Method of Use Dosing Regimen May-2043 PCT/CN2023/122092 (Pending)1 Method of Use Combin
Slide 24: Givastomig, a Potential Best-in-Class Claudin 18.2 Therapeutic
Givastomig, a Potential Best-in-Class Claudin 18.2 Therapeutic First CLDN18.2 asset tested in U.S. with immuno-chemotherapy standard of care in 1L gastric cancer Notes: scFv = single chain Fragment-variable region; 1L = first line; CLDN18.2 = Claudin 18.2 83% ORR at doses selected for ongoing dose e
Slide 25: Ragistomig (ABL503) targeting PD-L1 and 4-1BB
Molecular Design: Molecule binds to PD-L1 for activation of 4-1BB in the TME Implications: Mitigation of liver toxicity and systemic immune response Enhancement of anti-tumor immunity and re-invigoration of exhausted T cells1 Development: Co-development with ABL Bio Combinations will require maximiz
Slide 26: Phase 1 Data Support Further Development as Monotherapy and in Combination
Phase 1 Data Support Further Development as a Monotherapy and in Combination with Other Agents Overview: 44 efficacy evaluable patients (53 enrolled) with advanced or relapsed/refractory solid tumors (NCT04762641) 64.2% (34/53) of patients enrolled had at least three prior lines of systemic anti-can
Slide 27: Manageable Safety Profile
Manageable Safety Profile MTD established with 7 mg/kg every two-week dosing Most common TRAEs were increased ALT and increased AST None of the transaminase elevations were accompanied by clinically significant, treatment-related bilirubin increases Grade ≥ 3 ALT or AST increases occurred in 24.5% (
Slide 28: Ragistomig Results Compared to Acasunlimab
Ragistomig Results Compared to Acasunlimab Phase 1 Ragistomig (ABL503) Acasunlimab (GEN1046) Phase Phase 1 (NCT04762641) Phase 1 (NCT03917381) Treatment Monotherapy 0.7 mg – 10 mg/kg, Q2W Monotherapy 25 – 1,200 mg, Q3W Diagnosis Advanced or refractory solid tumors Advanced or refractory solid tumors
Slide 29: Uliledlimab (Targeting CD73)
Uliledlimab (Targeting CD73) A potential best-in-class CD73 therapeutic Anti-CD73 CD73 Biology: CD73 is the rate-limiting enzyme and best target in the adenosine immunosuppressive pathway Key Advantages: Uliledlimab completely inhibits CD73 activity and the production of adenosine without the “hook
Slide 30: Uliledlimab Designed to Bind and Inhibit CD73 without a Hook Effect
CD73 enzyme activity inhibition Dose-dependent CD73 inhibition without the “hook effect”2 Uliledlimab Designed to Bind and Inhibit CD73 without a Hook Effect Open conformation (inactive) Closed conformation (active) Oleclumab1 Intra-dimer binding mode Inter-dimer binding mode Open conformation (inac
Slide 31: Uliledlimab May Completely Inhibit CD73 Function in vitro
Partial inhibition by inter-dimer binding mode Complete inhibition by intra-dimer binding mode Uliledlimab May Completely Inhibit CD73 Function in vitro Notes: Astra Zeneca is evaluating oleclumab in a Phase 3 study in patients with Stage III NSCLC Oleclumab (MEDI9447) was internally produced based
Slide 32: Uliledlimab + Toripalimab Data Support Patient Selection Based on CD73 Expression
Safety profile of combination comparable to CPI monotherapy studies Uliledlimab + Toripalimab Data Support Patient Selection Based on CD73 Expression and Show Manageable Toxicity Well tolerated up to the highest doses tested (45mg/kg Q3W), without MTD Most TRAEs/AEs were Grade 1 or 2 ORR% (n) PD-L1
Slide 33: Expected Upcoming Clinical Readouts Across Portfolio Programs
Cash, cash equivalents and short-term investments as of March 31, 2025, were $168.6M; no debt Cash position expected to fund givastomig Phase 1b studies and further development initiatives into 2027 Issued and outstanding ordinary shares of 187.8M representing the equivalent of 81.7M ADSs1 as of Mar
Slide 34: Appendix
BIOPHARMA Appendix
Slide 35: Givastomig: Phase 1 Monotherapy Efficacy in Heavily Pretreated Patients
Givastomig: Phase 1 Monotherapy Efficacy in Heavily Pretreated Patients Conclusion: Givastomig was well tolerated and exhibits monotherapy activity in heavily pre-treated GC patients with a range of CLDN18.2 expression Patient Overview: 43 efficacy evaluable patients with CLDN18.2+ GC/GEJ/EAC A medi
Slide 36: Preferred Term Adverse Events by Grade
Preferred Term (all numbers are n(%)) Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 All Grades Nausea 6 (14.0) 4 ( 9.3) 1 ( 2.3) - - 11 (25.6) Anemia 2 ( 4.7) 5 (11.6) 3 ( 7.0) - - 10 (23.3) White blood cell count decreased 4 ( 9.3) 3 ( 7.0) 3 ( 7.0) - - 10 (23.3) Vomiting 4 ( 9.3) 2 ( 4.7) 1 ( 2.3) - - 7
Slide 37: Evolving Competitive Landscape in 1L Gastric Cancer
Evolving Competitive Landscape in 1L Gastric Cancer Givastomig (bispecific) Bemarituzumab (mAb) Rilvegostomig (bispecific) Domvanalimab (mAb) Target CLDN18.2/4-1BB FGFR2b PD-1 / TIGIT TIGIT Mechanism of Action Conditional 4-1BB activation Blocking FGFR2 pathway, ADCC Blocking PD-1 and TIGIT pathways
Slide 38: I-Mab Biopharma IR Contact
I-Mab Biopharma IR Contact IR@imabbio.com Stay connected