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6-K 1 pr_-_esmo_gi_-_7-02-25.htm 6-K 6-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16 UNDER

THE SECURITIES EXCHANGE ACT OF 1934

For the month of July 2025

 

 

Commission File Number: 001-39173

 

 

I-MAB

2440 Research Boulevard, Suite 400

Rockville, MD 20850

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒                Form 40-F ☐

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


EXHIBIT INDEX

 

Exhibit No.

Description

 

 

99.1

 

Press Release - I-Mab Presents Positive Givastomig Phase 1b Dose Escalation Data in Combination with Immunochemotherapy in Patients with 1L Gastric Cancers at ESMO GI 2025

 

99.2

 

Presentation - A Phase 1b dose escalation study of givastomig, a CLDN18.2 x 4-1BB bispecific antibody, in combination with immunochemotherapy in HER2-negative, CLDN18.2-positive gastric, esophageal or gastro-esophageal junction adenocarcinoma

 

99.3

 

Investor Presentation - July 2, 2025

 

 

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

I-MAB

 

 

 

By

:

/s/ Joseph Skelton

 

Name

:

Joseph Skelton

 

Title

:

Chief Financial Officer

 

Date: July 2, 2025


EX-99.1 2 imab-ex99_1.htm EX-99.1 EX-99.1

 

 

Exhibit 99.1

 

img44095488_0.jpg

I-Mab Presents Positive Givastomig Phase 1b Dose Escalation Data in Combination with Immunochemotherapy in Patients with 1L Gastric Cancers at ESMO GI 2025

Data show confirmed ORR of 83% (10/12) at doses selected for ongoing expansion study

Median follow-up of 9.0 months as of the updated data cutoff

Responses observed in patients with low PD-L1 and/or CLDN18.2 expression

Company to host investor event on Tuesday, July 8th

ROCKVILLE, MD, July 2, 2025 (Globe Newswire) – I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced the presentation of positive Phase 1b combination data for givastomig, in combination with nivolumab and mFOLFOX6, at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2025 (ESMO GI 2025) in Barcelona (abstract #388MO). Givastomig is a bispecific antibody targeting Claudin 18.2 and 4-1BB. I-Mab plans to host a virtual investor event on Tuesday, July 8th (register here) to review these data.

 

The Phase 1b data (NCT04900818) show a confirmed objective response rate (ORR) of 71% across all doses (12/17), and 83% (10/12) at doses selected for the ongoing dose expansion study (8 mg/kg and 12 mg/kg). Responses occurred in tumors with low levels of PD-L1 expression and/or Claudin 18.2 (CLDN18.2) expression, with favorable overall tolerability. There were no Grade 3 or greater events for nausea and vomiting, and only one Grade 3 TRAE for increased liver enzymes. The data are based on the results of the dose escalation part of a Phase 1b study evaluating the givastomig combination as first line therapy (1L) in patients with Claudin 18.2-positive gastric cancers (≥1+ IHC staining intensity in ≥1% of tumor cells). The primary endpoint is safety. The study enrolled only patients in the U.S.

 

“The positive Phase 1b combination data presented at ESMO GI bolster our confidence in givastomig’s potential to be a best-in-class Claudin 18.2 directed therapy. Givastomig has been well tolerated when combined with immuno-oncology and chemotherapy, has shown a high objective response rate, with rapid onset and durable responses that have deepened over time, supported by consistent pharmacokinetic data and soluble 4-1BB induction,” said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab. “In addition, we are optimistic about the results from the 8 mg/kg and 12 mg/kg doses. These doses showed an ORR of 83%, with consistent responses across PD-L1 and Claudin 18.2 expression levels, and a favorable overall safety profile. These data further our conviction in the ongoing Phase 1b dose expansion study. We believe givastomig has broad potential in a number of gastric cancer settings and look forward to continued advancement of the program.”

 

“I am encouraged by the response rates, as well as the deepening of responses over time, demonstrated by the givastomig combination regimen in the Phase 1b dose escalation study that we presented today at ESMO GI. Despite approved therapies, targeted treatment options for gastric cancers continue to be limited. While the data are early, givastomig combination therapy demonstrates a high response rate across Claudin18.2 and PD-L1 expression levels,” said Samuel J Klempner, MD, Associate Professor of Medicine at Massachusetts General Hospital. “In addition, I have been pleased to observe that givastomig has a favorable overall tolerability profile with a low level of gastrointestinal side effects -- especially important for patients with gastric cancer. I look forward to participating in the ongoing givastomig clinical development program, and hope we may be able to expand the population of patients who may benefit from Claudin 18.2 directed agents.”

 

Virtual Investor Event:

Register (here) for the Post-ESMO GI 2025 Investor Event to be held on Tuesday, July 8th at 2:00 PM EDT. A replay of the webinar will be accessible on the Events page of the I-Mab website for 90 days.

 

Fireside Chat Event with Lucid Capital Markets to Recap the Presentation:

 


 

 

Tune in (here) for a fireside chat sponsored by Christopher Liu, PharmD, Managing Director at Lucid Capital Markets that will be accessible today at 2:00pm EDT on the Events page of the I-Mab website. A replay of the fireside chat will be available for 90 days.

 

ESMO GI Presentation Details:

A full copy of the ESMO GI presentation is available on the Publications and Presentations page of the I-Mab website here.

 

Givastomig Phase 1b Dose Escalation Data Summary in 1L Gastric Cancers

17 advanced metastatic gastric cancer patients were treated with givastomig across the 5 mg/kg (n=5), 8 mg/kg (n=6), and 12 mg/kg (n=6) dose levels as of the May 15, 2025 data cutoff. All patients were efficacy evaluable

 

Patient Characteristics:

The 17 patients enrolled in the study were treatment naïve metastatic gastric, esophageal or gastroesophageal adenocarcinomas
Patients were HER2-negative, Claudin 18.2-positive (defined as ≥1+ IHC staining intensity in ≥1% of tumor cells), regardless of PD-L1 expression levels
All patients were enrolled at sites within the United States

 

Efficacy Results:

Confirmed Objective Response Rates (ORRs):
o
71% of patients (12/17) achieved a partial response (PR) per RECIST v1.1
5 mg/kg (2/5)
8 mg/kg (5/6)
12 mg/kg (5/6)
o
At the doses selected for dose expansion (8 and 12 mg/kg), 83% (10/12) of patients achieved PRs
o
80% of patients (4/5) with CLDN18.2 expression below 75% (CLDN-Low) achieved a PR. The CLDN-Low response rate increased to 100% of patients (3/3) in the doses selected for expansion (8 and 12 mg/kg)
The disease control rate (DCR) was 100% across the three dose levels
Dose-dependent pharmacokinetics (PK) were observed, similar to monotherapy PK
Patients also experienced a dose dependent induction of soluble 4-1BB, a positive indicator of T cell activation and engagement

 

ORR: % (n)

All

(n=17)

Cohorts Chosen for Expansion

(8 and 12 mg/kg)

(n=12)

PD-L1

 

 

Any

71 (12/17)

83 (10/12)

≥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)

100 (1/1)

CLDN18.2

 

 

≥75

67 (8/12)

78 (7/9)

<75

80 (4/5)

100 (3/3)

 

ORR: % (n)

PD-L1 ≥ 5

PD-L1 < 5

CLDN18.2 ≥ 75

80 (8/10)

0 (0/2)

CLDN18.2 < 75

100 (1/1)

75 (3/4)

 

Durability:

8 of 17 patients remained on study treatment and the longest treatment duration was 13.3 months as of the data cutoff
Median follow-up was 9.0 months across all dose levels as of the data cutoff Treatment-related adverse events (TRAEs) leading to discontinuation of any treatment were 12% (two patients), five patients had progressive disease, two patients withdrew from the study for social reasons

 

Safety:

 


 

 

No dose limiting toxicities (DLT) were observed and a maximum tolerated dose (MTD) was not reached
Common TRAEs (≥10% of patients) were generally Grade 1 or Grade 2 including nausea, vomiting, infusion related reaction, fatigue, decreased appetite, diarrhea, abdominal pain, chills, dyspepsia and gastritis
Grade 3 TRAEs attributed to givastomig were rare, with single cases of abdominal pain, ALT/AST increases, gastritis, and infusion related reaction
Four cases of Grade 3 and two cases of Grade 4 treatment-related neutropenia were observed driven by an early restriction on prophylaxis use of G-CSF, which has been subsequently lifted. The neutropenia cases were primarily attributed to mFOLFOX6 in the 8 mg/kg cohorts
No Grade 5 TRAEs were reported

 

About Givastomig

Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for first line (1L) metastatic gastric cancers, with further potential in other solid tumors. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents.

 

An ongoing Phase 1b study is evaluating givastomig for the treatment of gastric cancer in the 1L setting in combination with standard of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy, in dose escalation and dose expansion cohorts. Dose escalation is complete, and enrollment in the first dose expansion cohort (n=20) finished ahead of schedule. Enrollment continues to progress ahead of schedule in the second dose expansion cohort (n=20). The study builds on positive Phase 1 monotherapy data.

 

Givastomig is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.

 

About I-Mab

I-Mab (NASDAQ: IMAB) is a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer. The Company’s differentiated pipeline is led by givastomig, a potential best-in-class, bispecific antibody (Claudin 18.2 x 4-1BB) designed to treat Claudin 18.2-positive gastric cancers. Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed for first-line metastatic gastric cancers, with additional potential in other solid tumors. In Phase 1 trials, givastomig was observed to maintain strong tumor-binding and anti-tumor activity, attributable to a potential synergistic effect of proximal interaction with Claudin 18.2 and 4-1BB, while minimizing toxicities commonly seen with other 4-1BB agents.

For more information, please visit www.i-mabbiopharma.com and follow us on LinkedIn and X.

I-Mab Forward Looking Statements

This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will”, “expects”, “believes”, “designed to”, “anticipates”, “future”, “intends”, “plans”, “potential”, “estimates”, “confident”, and similar terms or the negative thereof. I-Mab may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the SEC), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about I-Mab’s beliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the Company’s pipeline and clinical development of I-Mab’s drug candidates, including givastomig; the projected advancement of the Company’s portfolio and anticipated milestones and related timing; the Company’s expectations regarding the impact of data from ongoing and future clinical trials; the timing and progress of studies and trials (including with respect to patient enrollment); the potential benefits of givastomig; and the availability of data and information from ongoing studies and trials.

 


 

 

Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: I-Mab’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab’s drug candidates; I-Mab’s ability to achieve commercial success for its drug candidates, if approved; I-Mab’s ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab’s reliance on third parties to conduct drug development, manufacturing and other services; and I-Mab’s limited operating history and I-Mab’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the “Risk Factors” section in I-Mab’s annual report on Form 20-F filed with the SEC on April 3, 2025, as well as the discussions of potential risks, uncertainties, and other important factors in I-Mab’s subsequent filings with the SEC. All forward-looking statements are based on information currently available to I-Mab. I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law.

I-Mab Investor & Media Contacts

PJ Kelleher

LifeSci Advisors

+1-617-430-7579

pkelleher@lifesciadvisors.com

IR@imabbio.com

 

 

 

 


EX-99.2 3 imab-ex99_2.htm EX-99.2

Slide 1

A Phase Ib dose escalation study of givastomig, a CLDN18.2 x 4-1BB bispecific antibody, in combination with immunochemotherapy in HER2-negative, CLDN18.2-positive gastric, esophageal or gastro-esophageal junction adenocarcinoma Samuel J. Klempner, Farshid Dayyani, Jeremy Kratz, Sunnie Kim, Claire (Cong) Xu, Christoph M. Ahlers, Xuejun Liu, Jou-Ku Chung, Peter Sabbatini, Phillip A. Dennis, Sangmi Lee, Juyeun Jeon, Geoffrey Ku 02 July 2025


Slide 2

DECLARATION OF INTERESTS SJK has served as a consultant and/or in an advisory role for Bristol-Myers Squibb, Merck, Astellas, Daiichi-Sankyo, Natera, Novartis, AstraZeneca, Mersana, Sanofi-Aventis, Amgen, Boehringer-Ingelheim, Taiho Oncology, Eisai, BeiGene, Elevation Oncology, EsoBiotec, and Gilead. SJK reports prior stock/equity in Turning Point Therapeutics and Nuvalent. SJK is currently participating as an investigator on the study being presented.


Slide 3

Background Ku ESMO 2024 Shen JITC 2024 Givastomig, a CLDN18.2 x 4-1BB bispecific antibody, was well tolerated as monotherapy and showed activity in heavily pretreated CLDN18.2-positive gastric cancer patients.1 Givastomig exerts anti-tumor activity through CLDN18.2-based, tumor-directed T-cell activation.2 Dose-dependent pharmacokinetics and induction of soluble 4-1BB were observed. Here we present the preliminary data from the dose escalation of givastomig combined with nivolumab and FOLFOX. Highly potent CLDN18.2 mAb Higher affinity than zolbetuximab Binds to tumor cells with a wide range of CLDN18.2 expression Silenced Fc: IgG1 No ADCC or CDC Minimize unintended systemic immune activation driven by FcgR-mediated 4-1BB clustering Conditional 4-1BB agonist Localized T cell activation in TME leading to potent tumor killing and minimal 4-1BB-mediated liver toxicity or systemic immune response Anti-CLDN18.2 IgG1 Anti-4-1BB scFv Givastomig


Slide 4

Notes: GC = gastric cancer; GEJ = gastroesophageal junction; EAC = esophageal adenocarcinoma; mFOLFOX6 = standard of care chemotherapy regimen; Q2W = every two weeks; giva = givastomig; ORR = objective response rate; PK = pharmacokinetic; PD = pharmacodynamic; BoR = best overall response; DoR = duration of response; PFS = progression free survival; OS = overall survival; 1L = first line Phase Ib Study Design of Givastomig Combined with Immunochemotherapy Study Design: Multi-center, dose-escalation and expansion phase Ib study Enrolled only US patients Bayesian optimal interval design with at least four subjects per dose Eligibility: 1L unresectable or metastatic GC/GEJ/EAC (GEA) HER2-negative CLDN18.2 ≥1+ on ≥1% of tumor cells All comers PD-L1 Dose Level 1 (n=5) Giva 5 mg/kg + nivolumab 240 mg + mFOLFOX6 Q2W Dose Escalation (n=17) Dose Level 2 (n=6) Giva 8 mg/kg + nivolumab 240 mg + mFOLFOX6 Q2W Dose Level 3 (n=6) Giva 12 mg/kg + nivolumab 240 mg + mFOLFOX6 Q2W Endpoints: Primary: Safety Secondary: Response rate: ORR, BoR, DoR Survival: PFS, OS PK/PD Dose Expansion (n=40) Dose Level 3 (n=20) Giva 12 mg/kg + nivolumab 240 mg + mFOLFOX6 Q2W Dose Level 2 (n=20) Giva 8 mg/kg + nivolumab 240 mg + mFOLFOX6 Q2W Fully Enrolled Enrollment Ongoing


Slide 5

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%) 11 (65%) Asian 0 2 (33%) 2 (33%) 4 (23%) Black 0 1 (17%) 0 1 (6%) NR 0 0 1 (17%) 1 (6%) ECOG PS 0 4 (80%) 4 (67%) 1 (17%) 9 (53%) 1 1 (20%) 2 (33%) 5 (83%) 8 (47%) Tumor Location Gastric 3 (60%) 5 (83%) 6 (100%) 14 (82%) GEJ 1 (20%) 1 (17%) 0 2 (12%) Esophageal 1 (20%) 0 0 1 (6%) CLDN18.2 ≥ 75% 3 (60%) 5 (83%) 4 (67%) 12 (71%) < 75% 2 (40%) 1 (17%) 2 (33%) 5 (29%) ≥ 40% 4 (80%) 5 (83%) 5 (83%) 14 (82%) < 40% 1 (20%) 1 (17%) 1 (17%) 3 (18%) PD-L1 CPS ≥ 1 4 (80%) 5 (83%) 6 (100%) 15 (88%) < 1 1 (20%) 1 (17%) 0 2 (12%) MSI MSI-H 0 0 0 0 MSS 5 (100%) 6 (100%) 6 (100%) 17 (100%) Baseline Patient Characteristics Notes: DCO May 15, 2025 ECOG PS = Eastern Cooperative Oncology Group performance status; GEJ = gastroesophageal junction; CPS = combined positive score; MSI = microsatellite instability; MSI-H = microsatellite instability-high; MSS = microsatellite stable; NR = not reported


Slide 6

Key Adverse Events Related to Any Drug in ≥ 10% Adverse Event (n=17) Grades ≤ 2 Grade 3 Grade 4 All Grades Neutropenia 6 (35%) 4 (24%) 2 (12%) 12 (71%) Peripheral neuropathy 10 (59%) 0 0 10 (59%) Nausea 9 (53%) 0 0 9 (53%) Vomiting 6 (35%) 0 0 6 (35%) Infusion related reaction 6 (35%) 1 (6%) 0 7 (41%) Diarrhea 5 (29%) 0 0 5 (29%) Abdominal pain 2 (12%) 1 (6%) 0 3 (18%) Gastritis 1 (6%) 1 (6%) 0 2 (12%) ALT increased 1 (6%) 1 (6%) 0 2 (12%) AST increased 1 (6%) 1 (6%) 0 2 (12%) 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 20% 0 17% 12% Related SAE any drug 40% 17% 17% 24% Grade ≥3 TEAE 80% 67% 50% 65% Grade ≥3 TRAE giva 20% 17% 33% 24% Grade ≥3 TRAE any drug 60% 67% 33% 53% TRAE  interruption 0 50% 17% 24% TRAE  treatment DC 20% 0 17% 12% Disease progression 0 33% 0 12% TRAE any drug  death 0 0 0 0 Notes: DCO May 15, 2025 TEAE = treatment emergent adverse event; TRAE = treatment related adverse event; SAE = serious adverse event; DC = discontinuation; giva = givastomig Immune Related Adverse Events Adverse Event (n=17) Grades ≤ 2 Grade 3 Grade 4 All Grades Pneumonitis 1 (6%) 0 0 1 (6%) Immune nephritis 0 1 (6%) 0 1 (6%) Rash maculo-popular 2 (12%) 0 0 2 (12%) No Dose Limiting Toxicity was observed Givastomig Was Well Tolerated in Combination with Immunochemotherapy


Slide 7

Biomarker Confirmed ORR: % (n) All Escalation (n=17) Cohorts Chosen for Expansion (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) 100 (1/1) CLDN18.2 ≥ 75 67 (8/12) 78 (7/9) < 75 80 (4/5) 100 (3/3) Confirmed ORR: % (n) PD-L1 ≥ 5 PD-L1 < 5 CLDN18.2 ≥ 75 80 (8/10) 0 (0/2) CLDN18.2 < 75 100 (1/1) 75 (3/4) Notes: DCO May 15, 2025; PD-L1 assays:22C3 pharmDX, or local test; CLDN: Ventana SP455 or 43-14A SD = stable disease; PR = confirmed partial response; ORR = objective response rate; CPS = combined positive score; CLDN = Claudin 18.2 Objective Response Rate of 71% Across Range of PD-L1 & CLDN18.2 Expression


Slide 8

8 and 12 mg/kg (n=12) All (n=17) Median follow up (months) (95% CI) 7.8 (5.7, 10.2) 9.0 (6.1, 11.5) Median duration of response (months) (95% CI) NE (4.5, NE) NE (4.8, NE) PFS median (months) (95% CI) NE (4.5, NE) NE (4.8, NE) PFS 6 months (%) (95% CI) 81.5 (43.5, 95.1) 72.9 (42.6, 89.0) Notes: DCO May 15, 2025 PFS = progression free survival; CI = confidence interval; PD = progressive disease; PR = partial response; SD = stable disease; NE = not evaluable Responses are Rapid, Deep, and Sustained CPS CLDN


Slide 9

Givastomig appears to be well tolerated at 5 mg/kg, 8 mg/kg, and 12 mg/kg in combination with nivolumab and FOLFOX, without significant GI, hepatic, or immune-related toxicities. Dose-dependent pharmacokinetics and induction of soluble 4-1BB were observed with the combination, similar to monotherapy (data not shown). Promising preliminary efficacy of the combination with overall ORR of 71% and 83% at doses being explored in expansion (8 mg/kg and 12 mg/kg). Anti-tumor activity was observed in patients with a wide range of CLDN18.2 expression (e.g. 3/3 PRs < 40%) as well as low PD-L1 expression (CPS < 5%). Enrollment of dose expansion cohort at 8 mg/kg is completed and ongoing at 12 mg/kg (NCT04900818). Conclusions Notes: DCO May 15, 2025 GI = gastrointestinal; ORR = objective response rate; PR = confirmed partial response; CPS = combined positive score


Slide 10

I-Mab and the authors would like to thank all the patients and their families, as well as all the investigators, clinical trial researchers, personnel and staff who contributed to or participated in the trial ESMO GI 2025 Copies of this presentation obtained through QR (Quick Response) and/or text key codes are for personal use only and may not be reproduced without written permission of the authors.

EX-99.3 4 imab-ex99_3.htm EX-99.3

Slide 1

Transforming Potential into Reality I-Mab Biopharma July 2025


Slide 2

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 accessing the information contained in this presentation, you hereby acknowledge and agree that no representations, warranties, or undertakings, express or implied, are made by the Company or any of its directors, shareholders, employees, agents, affiliates, advisors, or representatives as to, and no reliance should be placed on the truth, accuracy, fairness, completeness, or reasonableness of the information or opinions presented or contained in, and omission from, this presentation. Neither the Company nor any of its directors, employees, agents, affiliates, advisors, or representatives shall be responsible or liable whatsoever (in negligence or otherwise) for any loss, howsoever arising from any information presented or contained in this presentation or otherwise arising in connection with the presentation, except to the extent required by applicable law. The information presented or contained in this presentation speaks only as of the date hereof and is subject to change without notice. This presentation includes statistical and other industry and market data that we obtained from industry publications and research, surveys, and studies conducted by third parties, and our own estimates of potential market opportunities. All of the market data used in this presentation involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such data. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. Our estimates of the potential market opportunities for our product candidates include several key assumptions based on our industry knowledge, industry publications, third-party research, and other surveys, which may be based on a small sample size and may fail to accurately reflect market opportunities. While we believe that our internal assumptions are reasonable, no independent source has verified such assumptions. Forward Looking Statements. This presentation contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “future”, “promising”, “may”, “plans”, “potential”, “will”, “could position”, “promise”, “advance”, “target”, “design”, “strategy”, “pipeline”, and “project”, and similar terms or the negative thereof. Statements that are not historical facts, including statements about I-Mab's beliefs and expectations, are forward-looking statements. The forward-looking statements in this presentation include, without limitation, statements regarding the following: the Company’s pipeline and capital strategy; the design and potential benefits, advantages, promise, attributes, and target usage of givastomig, ragistomig and uliledlimab; the projected development and advancement of the Company’s portfolio and anticipated milestones and related timing; the Company’s expectation regarding the potential market opportunity of gastric cancer, pancreatic ductal adenocarcinoma and cholangiocarcinoma; the market opportunity and I-Mab’s potential next steps (including the potential expansion, differentiation, or commercialization) for givastomig, ragistomig and uliledlimab; the Company’s expectations regarding the impact of data from past, ongoing and future studies and trials; the benefits of the Company’s collaboration with development partners; the timing and progress of studies (including with respect to patient enrollment and dosing); the availability of data and information from ongoing studies; and the Company’s expectations regarding its cash runway and future use of its cash position. These forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the following: I-Mab’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or new drug application/biologics license application approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab’s drug candidates; I-Mab’s ability to achieve commercial success for its drug candidates, if approved; I-Mab’s ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab’s reliance on third parties to conduct drug development, manufacturing and other services; I-Mab’s limited operating history and I-Mab’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and discussions of potential risks, uncertainties, and other important factors in I-Mab’s most recent annual report on Form 20-F and I-Mab’s subsequent filings with the U.S. Securities and Exchange Commission (the “SEC”). I-Mab may also make written or oral forward-looking statements in its periodic reports to the SEC, in its annual report to shareholders, in press releases and other written materials, and in oral statements made by its officers, directors, or employees to third parties. All forward-looking statements are based on information currently available to I-Mab. I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. Disclaimer


Slide 3

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 CD73 mAb 1L mNSCLC: Target population of 300k+ patients3 Co-developed with ABL Bio (givastomig also known as ABL111, ragistomig also known as ABL503) Kohei Shitara, et al, 2023 ASCO Annual Meeting (June 2-6), poster #4035; Markets include U.S., five E.U., and Japan in 2025 based on Data Monitor Biomed Tracker Global Data Epidemiology Data, Guidehouse legacy research Notes: mNSCLC = metastatic non-small cell lung cancer; PD-(L)1 refers to inhibitors of PD-L1 or PD-1; Ab = antibody; mAb = monoclonal antibody; GC = gastric cancers; GEJ = gastroesophageal junction; EAC = esophageal adenocarcinoma cancer; 1L = first line; PFS = progression free survival; TJ Bio Taking a Step Beyond Traditional Early Drug Development


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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 observed across various CLDN18.2 expression levels, with higher binding affinity than other modalities Metastatic Gastric Cancer Expected to be a $12Bn TAM3 5-year survival rate of ~7%1 Metastatic gastric cancer impacts ~250k patients globally2 $12Bn addressable market by 20303 in mGC with potential to expand into other tumor types Near-Term Potential Value Creation Milestones Phase 1b escalation study of givastomig in combination with nivolumab plus chemotherapy fully enrolled (n=17); topline data presented in oral presentation at ESMO GI 2025 Phase 1b expansion study enrolling ahead of schedule (n=40); topline data expected in Q1 2026 Strong Capital Position with Cash Through Major Readouts $168.6M of cash as of March 31, 20254; expected to provide runway into 2027 based on current operating model, through expected clinical readouts for givastomig Capital efficient operating model with U.S.-based management team and clinical operations The American Cancer Society; based on people diagnosed with metastatic gastric cancers between 2014 and 2020 Markets include U.S., five E.U. countries, and Japan in 2025 for patients based on Data Monitor Biomed Tracker Markets include U.S., five E.U. countries, and Japan by 2030 for potential sales based on Data Monitor Biomed Tracker Includes cash and cash equivalents, and short-term investments Notes: ESMO GI = European Society of Medical Oncology Gastrointestinal Cancers Congress 2025; mGC = metastatic gastric cancer; TAM = total addressable market


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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 expected by 20303 Significant Unmet Need in Gastric Cancer with Limited Treatment Options Current 1L Standards of Care Leave Significant Room for Improvement4 ORR – (%) mPFS – (months) Sung 2021​; Markets include U.S., five E.U. countries, and Japan in 2025 based on Data Monitor Biomed Tracker The American Cancer Society; based on patients diagnosed with metastatic gastric cancers between 2014 and 2020; https://doi.org/10.1016/j.ctarc.2024.100845 Markets include U.S., five E.U. countries, and Japan by 2030 for potential sales based on Data Monitor Biomed Tracker Study results included in FDA approval labels; CHECKMATE-649 used CapeOX in certain patients; comparisons are not based on data from head-to-head trials and are not direct comparisons Notes: ORR = objective response rate; mPFS = median progression free survival; 1L = first line CHECKMATE-649 SPOTLIGHT CHECKMATE-649 SPOTLIGHT


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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 chemotherapy alone (80-90% of patients treated with I/O plus chemotherapy, not chemotherapy alone) Significant Opportunity to Address Broad CLDN18.2 Market High unmet need remains with approximately half of CLDN18.2-positive patients ineligible for approved therapy Opportunity to differentiate from existing approved therapy particularly in GI toxicities Shitara, K., Xu, RH., Ajani, J.A. et al. Global prevalence of claudin 18 isoform 2 in tumors of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Gastric Cancer 27, 1058–1068 (2024) VYLOY (zolbetuximab-clzb) FDA label Notes: IHC = immunohistochemistry; GI = gastrointestinal; I/O = immuno-oncology; CLDN18.2 = Claudin 18.2; CLDN18 = Claudin 18.2 and Claudin 18.1 Approved Therapy Only Addresses Portion of the Population Cut-Off of ≥1% CLDN18.2 Expression Doubles Number of Patients Eligible for Approved CLDN18.2-based Therapy


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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 March 31, 2025 Expected Upcoming Clinical Readouts Across Portfolio Programs Selected Financial Information Anticipated Upcoming Milestones Timing Program Milestone Q4 2025 Givastomig Phase 1 GC/GEJ/EAC monotherapy data Updated data from Phase 1 monotherapy study in CLDN18.2 gastric cancer patients Q1 2026 Givastomig Phase 1b GC/GEJ/EAC dose expansion data Topline data from combination with nivolumab plus chemo (n=40) 2H 2026 Uliledlimab Phase 2 PFS data from uliledlimab + toripalimab Randomized study against pembrolizumab alone or toripalimab alone (TJ Bio China-only data) Ongoing Ragistomig Phase 1b dose expansion enrolling Additional cohorts to expand the therapeutic index Assuming the conversion of all ordinary shares into ADSs Notes: GC = gastric cancer; GEJ = gastroesophageal junction; EAC = esophageal adenocarcinoma; PFS = progression free survival; TJ Bio = TJ Biopharma; ESMO GI = European Society of Medical Oncology Gastrointestinal Cancers Congress 2025; CLDN18.2 = Claudin 18.2


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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 compared to reference antibody zolbetuximab Localized T cell activation in TME expected to minimize 4-1BB-mediated liver toxicity and systemic immune response Lead Program, Givastomig (Targeting Claudin 18.2 and 4-1BB) A potential best-in-class CLDN18.2 therapeutic for gastric cancer Notes: scFv = single chain Fragment-variable region; TME = tumor microenvironment; 1L = first line; CLDN18.2 = Claudin 18.2 4-1BB scFv CLDN18.2


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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 minimize unintended systemic immune activation driven by FcgR-mediated 4-1BB clustering Conditional 4-1BB agonist Localized T cell activation in TME leading to tumor killing and minimal 4-1BB-mediated liver toxicity or systemic immune response Givastomig, a Bispecific Antibody Targeting Claudin 18.2 and 4-1BB Designed for balance between anti-tumor efficacy and safety Source: Revised from https://www.nature.com/articles/d43747-020-00568-5 Notes: IgG1 = Immunoglobin G1; scFv = single chain Fragment-variable region; ADCC = antibody-dependent cell-mediated cytotoxicity; CDC = complement-dependent cytotoxicity; TME = tumor microenvironment; CLDN18.2 = Claudin 18.2; MHC = major histocompatibility complex; mAb = monoclonal antibody


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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 risk of CRS Monoclonal Antibody (Zolbetuximab) Tumor killing by ADCC, ADCP, and CDC High risk of on-target GI toxicity Comparison of Claudin 18.2-targeted Therapeutics Mechanisms of Action Anti-CD3 Anti-CLDN18.2 Bispecific 4-1BB T Cell Activator (Givastomig) Tumor killing by enhanced TDCC with anti-tumor memory by activating 4-1BB costimulatory signal, and bystander killing Anti-CLDN18.2 Anti-4-1BB CDC ADCC TDCC & Bystander killing Cytotoxicity Bystander killing 4-1BB ADCP 4 4 3 2 1 Source: Revised from Nat Rev Clin Oncol. 2024 May;21(5):354-369 Notes: ADCC = antibody-dependent cell-mediated cytotoxicity; ADCP = antibody-dependent cellular phagocytosis; CDC = complement-dependent cytotoxicity; TDCC = T cell dependent cellular cytotoxicity; CRS = cytokine release syndrome; GI = gastrointestinal


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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 Previously treated GC/GEJ Previously treated GC/GEJ/EAC Efficacy Evaluable (n) 43 451 15 43 ORR (%) 16% (7/43) 18% (8/45)1 Zero 9% (4/43) DCR (CR+PR+SD, %) 49% (21/43) 49% (22/45)1 1 SD 23% (10/43) Source Givastomig poster #1017P ESMO 2024 U Sahin et al. European Journal of Cancer 100 (2018) 17e26 O Tureci et al. Annals of Oncology 30: 1487–1495, 2019 Two additional patients dosed post ESMO 2024 data cutoff Notes: mAb = monoclonal antibody; ORR = objective response rate; DCR = disease control rate; CR = complete response; PR = partial response; SD = stable disease; GC = gastric cancer; GEJ = gastroesophageal junction; EAC = esophageal cancer; IHC = immunohistochemistry. Note that the comparisons in the table above are not based on data from head-to-head trials and are not direct comparisons. Differences in trial designs, patient groups, trial endpoints, study sizes and other factors may impact the comparisons


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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 ADCC and CDC Direct cytotoxicity, ADCC, CDC, and bystander effects Activation & proliferation of T cells Claudin 18.2 Threshold 1+ ≥1% 2+, 3+ ≥50% 2+ ≥5% 2+, 3+ ≥10% ORR 18% 9% 28% 26% All Grades Grade ≥ 3 All Grades Grade ≥ 3 All Grades Grade ≥ 3 All Grades Grade ≥ 3 Safety# TEAE 100% 71% 96% NR 100% 68% 100% 69% TRAE 78% 33% 82% NR 99% 57% 100% 58% Neutropenia 14%* 5%* <10%^ NR 53%^ 21%^ <10% NR Nausea 20% 2% 63%^ 15%^ 57%^ 4%^ 37% 7% Vomiting 11% 2% 57%^ 22%^ 56%^ 10%^ 23% 3% ALT / AST 16% / 16% 2% / 4% <10%^ / <10%^ NR 29%^ / 42%^ 0%^ / 0%^ 44% / 45% 3% / 1% GGT 11% 2% <10%^ NR 14%^ 1%^ 41% 19% CRS 2% 0% <10%^ NR NR NR 54% 0.8% Development Status Phase 1b nivolumab + mFOLFOX6 in 1L GC ongoing Zolbe + chemotherapy approved in CLDN18.2-high 1L GC Phase 3 monotherapy in 2L+ GC ongoing Phase 1 monotherapy & combination with I/O ongoing in 2L+ GC # = TRAE unless noted; ^ = TEAE; * = including febrile neutropenia; NR = Not reported 1) Annals of Oncology; 2) Ruan, Lancet 2025; 3) Hao, Zheng 2024 ASCO Notes: ORR = objective response rate; GC = gastric cancer; ADCC = antibody dependent cellular cytotoxicity; CDC = complement-dependent cytotoxicity; 1L = first line; 2L = second line. Note that the comparisons in the table above are not based on data from head-to-head trials and are not direct comparisons. Differences in trial designs, patient groups, trial endpoints, study sizes and other factors may impact the comparisons


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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/MTD = multiple ascending dose or maximum tolerated dose; ORR = objective response rate; PK = pharmacokinetic; PD = pharmacodynamic; BoR = best overall response; DoR = duration of response; PFS = progression free survival; OS = overall survival; 1L = first line; BOIN = Bayesian optimal interval; PD-L1 = programmed death-ligand 1 Phase 1b Study Design of Givastomig Combined with Immuno-chemotherapy Study Design: Multi-center, dose-escalation and expansion phase 1b study Enrolled only U.S. patients BOIN with at least four subjects per dose Eligibility: 1L unresectable or metastatic GC/GEJ/EAC (GEA) HER2-negative CLDN18.2 ≥1+ on ≥1% of tumor cells All comers PD-L1 Dose Escalation (n=17) Dose Expansion (n=40) Giva 12 mg/kg + nivolumab 240 mg + mFOLFOX6 Q2W Dose Level 3 (n=6) Dose Level 2 (n=6) Giva 8 mg/kg + nivolumab 240 mg + mFOLFOX6 Q2W Dose Level 1 (n=5) Giva 5 mg/kg + nivolumab 240 mg + mFOLFOX6 Q2W Dose Level 3 (n=20) Giva 12 mg/kg + nivolumab 240 mg + mFOLFOX6 Q2W Enrollment Ongoing Dose Level 2 (n=20) Giva 8 mg/kg + nivolumab 240 mg + mFOLFOX6 Q2W Fully Enrolled Dose expansion data expected Q1 2026


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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%) 11 (65%) Asian 0 2 (33%) 2 (33%) 4 (23%) Black 0 1 (17%) 0 1 (6%) NR 0 0 1 (17%) 1 (6%) ECOG PS 0 4 (80%) 4 (67%) 1 (17%) 9 (53%) 1 1 (20%) 2 (33%) 5 (83%) 8 (47%) Tumor Location Gastric 3 (60%) 5 (83%) 6 (100%) 14 (82%) GEJ 1 (20%) 1 (17%) 0 2 (12%) Esophageal 1 (20%) 0 0 1 (6%) CLDN18.2 ≥ 75% 3 (60%) 5 (83%) 4 (67%) 12 (71%) < 75% 2 (40%) 1 (17%) 2 (33%) 5 (29%) ≥ 40% 4 (80%) 5 (83%) 5 (83%) 14 (82%) < 40% 1 (20%) 1 (17%) 1 (17%) 3 (18%) PD-L1 CPS ≥ 1 4 (80%) 5 (83%) 6 (100%) 15 (88%) < 1 1 (20%) 1 (17%) 0 2 (12%) MSI MSI-H 0 0 0 0 MSS 5 (100%) 6 (100%) 6 (100%) 17 (100%) Notes: Data cutoff as of June 10, 2025 ECOG PS = Eastern Cooperative Oncology Group performance status; GEJ = gastroesophageal junction; CPS = combined positive score; MSI = microsatellite instability; MSI-H = microsatellite instability-high; MSS = microsatellite stable; NR = not reported; CLDN18.2 = Claudin 18.2; PD-L1 = programmed death-ligand 1


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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) 100 (1/1) CLDN18.2 ≥ 75 67 (8/12) 78 (7/9) < 75 80 (4/5) 100 (3/3) ORR: % (n) PD-L1 ≥ 5 PD-L1 < 5 CLDN18.2 ≥ 75 80 (8/10) 0 (0/2) CLDN18.2 < 75 100 (1/1) 75 (3/4) Notes: Data cutoff as of May 15, 2025; PD-L1 assays:22C3 pharmDX, or local test; CLDN: Ventana SP455 or 43-14A; SD = stable disease; PR = confirmed partial response; ORR = objective response rate; CPS = combined positive score; PD-L1 = programmed death-ligand 1; CLDN18.2 = Claudin 18.2; CLDN = Claudin 18.2


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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


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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/kg dose level (low PD-L1 and low CLDN) continues beyond 12 months 4 out of 6 patients remain on study at the 12mg/kg dose level Notes: Data cutoff as of May 15, 2025 PFS = progression free survival; CI = confidence interval; PD = progressive disease; PR = partial response; SD = stable disease; NE = not evaluable; CPS = combined positive score; CLDN = Claudin 18.2; PD-L1 = programmed death-ligand 1


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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-life ~140 hours Induction of soluble 4-1BB observed to be positively correlated with exposure of givastomig Induction of soluble 4-1BB in monotherapy observed to plateau above 8mg/kg Induction in soluble 4-1BB in combination study at 12 mg/kg observed to be higher than that at 8 mg/kg, but not statistically significant. Difference between 12 mg/kg and 5 mg/kg observed to be statistically significant Notes: PK = pharmacokinetic; PD = pharmacodynamic; PR = partial response; SD = stable disease


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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 20% 0% 17% 12% Related SAE any drug 40% 17% 17% 24% Grade ≥3 TEAE 80% 67% 50% 65% Grade ≥3 TRAE giva 20% 17% 33% 24% Grade ≥3 TRAE any drug 60% 67% 33% 53% TRAE  interruption 0% 50% 17% 24% TRAE  treatment DC 20% 0% 17% 12% Disease progression 0% 33% 0% 12% TRAE any drug  death 0% 0% 0% 0% Key Adverse Events Related to Any Drug in ≥ 10% Adverse Event (n=17) Grades ≤2 Grade 3 Grade 4 All Grades Neutropenia 6 (35%) 4 (24%) 2 (12%) 12 (71%) Peripheral neuropathy 10 (59%) 0 0 10 (59%) Nausea 9 (53%) 0 0 9 (53%) Vomiting 6 (35%) 0 0 6 (35%) Infusion related reaction 6 (35%) 1 (6%) 0 7 (41%) Diarrhea 5 (29%) 0 0 5 (29% Abdominal pain 2 (12%) 1 (6%) 0 3 (18%) Gastritis 2 (12%) 1 (6%) 0 3 (18%) ALT increased 1 (6%) 1 (6%) 0 2 (12%) AST increased 1 (6%) 1 (6%) 0 2 (12%) Immune Related Adverse Events Adverse Event (n=17) Grades ≤2 Grade 3 Grade 4 All Grades Pneumonitis 1 (6%) 0 0 1 (6%) Immune nephritis 0 1 (6%) 0 1 (6%) Rash maculo-papular 2 (12%) 0 0 2 (12%) Data cutoff as of June 10, 2025 TEAE = treatment emergent adverse event; TRAE = treatment related adverse event; SAE = serious adverse event; DC = discontinuation; giva = givastomig; ALT = alanine transaminase; AST = aspartate aminotransferase


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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 Grades 3 (18%) 2 (12%) 1 (8%) 1 (8%) 9% 16% 16% 18% ≥ Grade 3 1 (6%) 1 (6%) 0% 0% 1% 2% 3% 1% ALT increased All Grades 3 (18%) 2 (12%) 1 (8%) 1 (8%) 7% 11% 17% 12% ≥ Grade 3 2 (12%) 1 (6%) 0% 0% 1% 1% 3% 1% Neutropenia All Grades 12 (71%) 12 (71%) 8 (67%) 8 (67%) 39% 45% 67% 71% ≥ Grade 3 6 (35%) 6 (35%) 4 (33%) 4 (33%) 21% 26% 48% 53% Nausea All Grades 10 (59%) 9 (53%) 8 (67%) 7 (58%) 38% 41% 61% 82% ≥ Grade 3 0% 0% 0% 0% 2% 3% 6% 16% Vomiting All Grades 7 (41%) 6 (35%) 7 (58%) 6 (50%) 22% 25% 36% 67% ≥ Grade 3 0% 0% 0% 0% 3% 2% 6% 16% IRR All Grades 7 (41%) 7 (41%) 7 (58%) 7 (58%) NR NR NR NR ≥ Grade 3 1 (6%) 1 (6%) 1 (8%) 1 (8%) NR NR NR NR Givastomig Combination Safety: Comparable to Other 1L Combinations in GC TRAE (any drug), TEAE Janjigian 2021; The Lancet, Volume 398, Issue 10294, 27 - 40 Shitara et al. 2023; The Lancet, Volume 401, Issue 10389, 1655 - 1668 Data cutoff as of June 10, 2025 Notes: TEAE = treatment emergent adverse event; TRAE = treatment related adverse event; ALT = alanine transaminase; AST = aspartate aminotransferase; NR = not reported; IRR = infusion related reaction; 1L = first line; GC = gastric cancers


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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 patients diagnosed with gastric cancer globally1 Markets include U.S., 5 E.U., and Japan in 2025 based on Data Monitor Biomed Tracker HER2-negative status of 78%. Van Cutsem E, Bang YJ, Feng-Yi F, et al. HER2 screening data from ToGA : targeting HER2 in gastric and gastroesophageal junction cancer. Gastric Cancer 2015;18(3):476-84 CLDN18.2 positive status of ~70%. Kohei Shitara, et al, 2023 ASCO Annual Meeting (June 2-6), poster #4035 VYLOY (zolbetuximab-clzb) FDA label Notes: CPS = combined positive score; BIC = best-in-class; FIC = first-in-class; 1L = first line 10% 1%


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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 Assay Validation Report on file >70%4 Gastric Cancer ~$12Bn1 60-85%5 Pancreatic Ductal Adenocarcinoma ~$6Bn2 ~70%5 Cholangiocarcinoma ~$3Bn3 Ongoing Trials* Clinical POC* Market Opportunity Prevalence of CLDN18.2 Expression Significant Opportunity for Claudin 18.2 Asset Class Beyond Gastric Cancer CLDN18.2 class has substantial estimated market potential in oncology by 2030 * Representative of entire competitive landscape – not I-Mab specific


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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 Combination with Second Therapeutic Agent Sep-2043 US 63/693,641 (Pending)1 Method of Use Dosing Regimen and Combination Therapy Sep-2045 Applications pending, expiration date approximated based on expected grant date(s) Treatment of Cancer Dosing Regimen Combination with Second Therapeutic Agent Dosing Regimen and Combination Therapy


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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 expansion study, with favorable overall tolerability, with a low level of gastric side effects Rapid and durable responses that deepened over time Broad potential in gastric cancers and other solid tumors 4-1BB scFv CLDN18.2 Responses observed in patients with low PD-L1 and/or CLDN18.2 expression


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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 maximizing the therapeutic index Implications: Further testing of additional doses and interval administration to maximize the therapeutic index Ragistomig (ABL503) targeting PD-L1 and 4-1BB A novel bispecific integrates PD-L1 as a tumor engager and 4-1BB as a conditional T cell activator 4-1BB scFv PD-L1 IgG JITC 2021 Notes: scFv = single chain Fragment-variable region; TME = tumor microenvironment


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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-cancer treatment Efficacy Results at 3 and 5 mg/kg Q2W: Objective Response Rate (ORR) of 26.9% (7/26), Clinical Benefit Ratio (CBR) of 69.2% (18/26) One CR, six PRs, eleven SDs 71.4% of responders had received prior anti-PD-(L)-1 inhibitors The CR was observed in a heavily pretreated ovarian cancer patient dosed at 3 mg/kg (seven lines of prior therapy) Conclusion: Compelling clinical data in checkpoint inhibitor relapsed/refractory and I/O naïve patients Treatment Duration (Days) CR start PR start On-going PD start 0.7 mg 2 mg/kg 2 mg 3 mg/kg 7 mg 5 mg/kg 0.3 mg/kg 7 mg/kg 1 mg/kg 10 mg/kg Source: ASCO 2024 Notes: Data cut-off as of April 19, 2024. CR = complete response; PR = partial response; PD = progressive disease; SD = stable disease; I/O = Immuno-oncology; Q2W = every two weeks


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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% (13/53) of patients and improved with corticosteroids or ragistomig treatment interruption No cytokine release syndrome occurred, and one infusion-related reaction occurred at 5 mg/kg (Grade 2) ABL503 monotherapy Demography All patients (N = 53) All grades, n(%) Grade ≥ 3, n(%) Any TRAE 40 (75.5) 22 (41.5) TRAE occurring in ≥ 10% of patients Alanine aminotransferase increased 17 (32.1) 12 (22.6) Aspartate aminotransferase increased 16 (30.2) 11 (20.8) Pyrexia 8 (15.1) 1 (1.9) Nausea 7 (13.2) - Rash 7 (13.2) 2 (3.8) Fatigue 6 (11.3) 1 (1.9) Platelet count decreased 6 (11.3) 1 (1.9) Source: ASCO 2024 poster, Table 2 Notes: Data cut-off as of April 19, 2024. MTD = maximally tolerated dose; TRAE = treatment-related adverse events; ALT = alanine aminotransferase; AST = aspartate aminotransferase


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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 Efficacy Evaluable 26 (sum of 3 mg/kg and 5 mg/kg) 61 (25 – 1,200 mg) 30 (80 – 200 mg) ORR 26.9% (7/26) 6.6% (4/61) 13.3% (4/30, 80 – 200 mg) DCR (CR+PR+SD) 69.2% (18/26) 65.6% (40/61) Safety Grade 3 AST / ALT: 24.5% (13/53) Grade 3 AST / ALT: 10% Source Ragistomig poster ASCO 2024 Cancer Discovery 2022 Notes: ASCO 2024 = American Society for Clinical Oncology Annual Meeting; ORR = objective response rate; DCR = disease control rate; CR complete response; PR = partial response; SD = stable disease; AST = aspartate aminotransferase; ALT = alanine aminotransferase; Q2W = every two weeks. Note that the comparisons in the table above are not based on data from head-to-head trials and are not direct comparisons. Differences in trial designs, patient groups, trial endpoints, study sizes, and other factors may impact the comparisons


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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 effect”1 Development: Coordinated global development with TJ Bio Status: I-Mab development paused pending positive data from TJ Bio’s ongoing doublet study in 1L CD73+ NSCLC AACR 2021 Note: mNSCLC = metastatic non-small cell lung cancer; AMP = adenosine monophosphate; TJ Bio = TJ Biopharma


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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 (inactive) Closed conformation (active) Unique intra-dimer binding through a C-terminus epitope Uliledlimab inhibits CD73 by binding to the C-terminus and preventing CD73 dimerization Oleclumab inhibits CD73 by binding to the N-terminus and preventing CD73 dimerization Uliledlimab CD73 enzyme activity inhibition Uliledlimab concentration Oleclumab concentration Uliledlimab CD73 dimer Oleclumab CD73 dimer Binding site Binding site Oleclumab (MEDI9447) was internally produced based upon the published sequence AACR 2021 Source: I-MAB information on file


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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 upon the published sequence


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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 All PD-L1>1% CD73High 53% (10/19) 63% (10/16) CD73Low 18% (8/45) 20% (5/25) Pembro (KN-042) PD-L1>1% NA 27% (174/637) Phase 2 ORR data from front-line NSCLC Cohort* Safety observations for uliledlimab, administered to >200 patients in combination studies with CPIs Notes: ORR = objective response rate; MTD = maximally tolerated dose; Q3W = every three weeks; AE = adverse events; CPI = checkpoint inhibitors; TRAEs = treatment-related adverse events; ASCO 2023 = the American Society of Clinical Oncology 2023 Annual Meeting; toripalimab (used in this study) = Approved/China and the US (Shanghai Junshi Biosciences/Coherus Biosciences) *Patient disposition based on ASCO 2023 Poster from a cohort of 70 enrolled patients with unresectable/metastatic disease, including 67 efficacy evaluable and 64 patients who received at least one post baseline tumor assessment per iRECIST. Overall study (up to n=190) enrolled 5 cohorts (3 NSCLC sub-types, 1 ovarian, 1 all comers): data in this deck are from the treatment naïve, Stage IV NSCLC patients


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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 March 31, 2025 Expected Upcoming Clinical Readouts Across Portfolio Programs Selected Financial Information Anticipated Upcoming Milestones Timing Program Milestone Q4 2025 Givastomig Phase 1 GC/GEJ/EAC monotherapy data Updated data from Phase 1 monotherapy study in CLDN18.2 gastric cancer patients Q1 2026 Givastomig Phase 1b GC/GEJ/EAC dose expansion data Topline data from combination with nivolumab plus chemo (n=40) 2H 2026 Uliledlimab Phase 2 PFS data from uliledlimab + toripalimab Randomized study against pembrolizumab alone or toripalimab alone (TJ Bio China-only data) Ongoing Ragistomig Phase 1b dose expansion enrolling Additional cohorts to expand the therapeutic index Assuming the conversion of all ordinary shares into ADSs Notes: GC = gastric cancer; GEJ = gastroesophageal junction; EAC = esophageal adenocarcinoma; PFS = progression free survival; TJ Bio = TJ Biopharma; ESMO GI = European Society of Medical Oncology Gastrointestinal Cancers Congress 2025; CLDN18.2 = Claudin 18.2


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Appendix


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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 median of three prior lines of systemic therapy (range 1-6); doses between 5-18 mg/kg1 Cohort is a subset of Phase 1a (NCT04900818) Responses: Seven partial responses (PR) observed with an objective response rate (ORR) of 16.3% (7/43) Stable disease (SD) was reported in 14 patients, implying a disease control rate (DCR) of 48.8% (21/43) CLDN18.2 expression in responders ranged from 11% to 100%. Additionally, five responders had received prior treatment with PD-1 or PD-L1 inhibitors Source: Data on file (IMAB) Defined as the predicted efficacious dosing range, based on preclinical studies Notes: Data cut-off as of July 30, 2024; GC = gastric cancer; GEJ = gastroesophageal junction; EAC = esophageal adenocarcinoma 5 mg/kg Numbers: CLDN18.2 % PD SD PR x = Death 8 mg/kg 12 mg/kg 15 mg/kg 18 mg/kg Treatment Ongoing >


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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 (16.3) Decreased appetite 3 ( 7.0) 2 ( 4.7) 1 ( 2.3) - - 6 (14.0) Alanine aminotransferase increased 2 ( 4.7) 2 ( 4.7) 1 ( 2.3) - - 5 (11.6) Aspartate aminotransferase increased 3 ( 7.0) - 2 ( 4.7) - - 5 (11.6) Gamma-glutamyl transferase increased 1 ( 2.3) 3 ( 7.0) 1 ( 2.3) - - 5 (11.6) Neutrophil count decreased 1 ( 2.3) 3 ( 7.0) 1 ( 2.3) - - 5 (11.6) Infusion related reaction 1 ( 2.3) 2 ( 4.7) 1 ( 2.3) - - 4 ( 9.3) Lymphocyte count decreased - - 4 ( 9.3) - - 4 ( 9.3) Fatigue 2 ( 4.7) 1 ( 2.3) - - - 3 ( 7.0) Headache 2 ( 4.7) 1 ( 2.3) - - - 3 ( 7.0) Hypoalbuminemia 2 ( 4.7) 1 ( 2.3) - - - 3 ( 7.0) Lipase increased 1 ( 2.3) 1 ( 2.3) 1 ( 2.3) - - 3 ( 7.0) Platelet count decreased 1 ( 2.3) 1 ( 2.3) - 1 ( 2.3) - 3 ( 7.0) Weight decreased 2 ( 4.7) 1 ( 2.3) - - - 3 ( 7.0) Treatment-related adverse events (TRAEs) occurring in >5% (n=43) No DLT was reported up to 15 mg/kg Q2W and 18 mg/kg Q3W, and MTD was not reached Most commonly reported TRAEs (>20% of subjects): Grade 1, 2 or 3 nausea (25.6%), anemia (23.3%), white blood cell count decreased (23.3%) 15 subjects (34.9%) experienced at least one Grade ≥ 3 TRAE with no Grade 5 TRAEs Most gastrointestinal TRAEs were Grade 1 or 2 and do not appear to be dose-related Givastomig: Phase 1 Monotherapy Safety – Treatment Related AEs Source: ESMO 2024 Notes: Data cut-off as of June 1, 2024; DLT = dose-limiting toxicity; MTD = maximum tolerated dose; AE = adverse event; TRAE = treatment emergent adverse event; Q2W = every two weeks; Q3W = every three weeks


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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 Blocking TIGIT pathway Company I-Mab Amgen AstraZeneca Arcus Geography US Global Global US/Korea Target population CLDN18.2+, HER2- (~70% HER2-) FGFR2b+, HER2- (11-19% HER2-) HER2- HER2- Add-On nivolumab + mFOLFOX6 mFOLFOX6 XELOX or FOLFOX Zimberelimab + FOLFOX ORR 83% 57% 68% (53% confirmed) 59% (54% confirmed) mPFS (month) Not mature 14.0 NR NR mOS (month) Not mature 24.7 NR NR Grade ≥3 TEAEs 65% 83% (41% d/c rate, 77% due to ocular AE) 45% 66% Data Source ESMO GI 2025 FIGHT Phase 2 ESMO 2024 ASCO 2023 Note that the comparisons in the table above are not based on data from head-to-head trials and are not direct comparisons. Differences in trial designs, patient groups, trial endpoints, study sizes and other factors may impact the comparisons Notes: ORR = objective response rate; mPFS = median progression free survival; mOS = median overall survival; TEAE = treatment emergent adverse event; 1L = first line; NR = not reported; FGFR2b = fibroblast growth factor receptor 2; HER2 = human epidermal growth factor receptor 2; mAb = monoclonal antibody; TIGIT = T cell immunoreceptor with Ig and ITIM domains; ADCC = antibody dependent cellular cytotoxicity; PD-1 = programmed cell death protein; d/c rate = discontinuation rate; ESMO = European Society of Medical Oncology Congress; ASCO = American Society of Clinical Oncology


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