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 02, 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 pres ...

Monotherapy efficacy and safety profile provided backbone for clinical development strategy in 1L combination with nivolumab plus chemotherapy ROCKVILLE, MD, June 30, 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 publication of the first-in-human monotherapy data for givastomig, a bispecific Claudin 18.2 x 4-1BB antibody, in Clinical Cancer Research ...

Core Insights - I-Mab announced positive data from a Phase 1b study of givastomig in combination with nivolumab and mFOLFOX6 for metastatic gastric cancers, showing an objective response rate (ORR) of 71% across all dose levels and 83% in the selected dose expansion cohort [1][2][3] Study Details - The Phase 1b study evaluated the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of givastomig as first-line therapy in Claudin 18.2-positive gastric cancers, with a primary endpoint focused on safety [2][18] - The study enrolled 17 treatment-naïve patients with advanced metastatic gastric, esophageal, or gastroesophageal adenocarcinomas [6][18] Efficacy Results - Overall, 71% (12/17) of patients achieved a partial response (PR) per RECIST v1.1, with a higher response rate of 83% (10/12) in the dose levels selected for expansion (8 and 12 mg/kg) [9][13] - The disease control rate (DCR) was reported at 100% across all dose levels [13] - Notably, responses were observed in patients with low PD-L1 and/or CLDN18.2 expression [1][3] Safety Profile - The safety profile of givastomig was favorable, with no dose-limiting toxicities (DLT) observed and a maximum tolerated dose (MTD) not reached [14][15] - Common treatment-related adverse events (TRAEs) were generally Grade 1 or Grade 2, including nausea, vomiting, and fatigue, with rare Grade 3 TRAEs reported [14][15] Upcoming Events - Updated results from the study will be presented at the ESMO GI 2025 on July 2nd, and the company will host a virtual investor event on July 8th to discuss the findings [1][12]

Virtual investor event planned for July 8 at 2:00pm EDT ROCKVILLE, Md., June 18, 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 that it will host a webinar to recap new givastomig data being presented at ESMO GI 2025, with a key opinion leader (KOL), on Tuesday, July 8, 2025 at 2:00pm EDT. To register, click here. Event to follow presentation of ne ...

Core Viewpoint - I-Mab has regained compliance with Nasdaq's minimum bid price requirement, allowing its American Depositary Shares to continue trading on the exchange [1][2]. Company Overview - I-Mab is a U.S.-based global biotech company focused on developing precision immuno-oncology agents for cancer treatment [3]. - The company's leading pipeline product is givastomig, a bispecific antibody targeting Claudin 18.2, designed for treating Claudin 18.2-positive gastric cancers [3]. - Givastomig is being developed for first-line metastatic gastric cancers and shows potential in other solid tumors, demonstrating strong tumor-binding properties and anti-tumor activity in Phase 1 trials [3].

Core Points - I-Mab, a U.S.-based global biotech company, focuses on developing precision immuno-oncology agents for cancer treatment [1][2] - The management team of I-Mab will participate in the Jefferies Global Healthcare Conference from June 3-5, 2025, discussing clinical progress on its lead program, givastomig [1][2] - New data on givastomig has been accepted for a Mini Oral presentation at the ESMO Gastrointestinal Cancers Congress 2025, scheduled for July 2, 2025, in Barcelona, Spain [2] Company Information - I-Mab is headquartered in Rockville, Maryland, and has operations in Short Hills, New Jersey [2] - The company is publicly traded on NASDAQ under the ticker IMAB [1][2] - For more information, I-Mab's website and social media channels are available [2]

Core Insights - I-Mab has reported strong progress in its lead program, givastomig, aimed at treating gastric cancers, with patient enrollment in Phase 1b dose expansion cohorts completed ahead of schedule [2][3] - The company has a robust cash position of $168.6 million as of March 31, 2025, which is expected to fund ongoing studies and development initiatives into 2027 [6][8] - The anticipated milestones for givastomig include data presentations at the ESMO GI Congress in July 2025 and further updates in 2026 [3][4] Financial Performance - For Q1 2025, research and development expenses decreased to $0.8 million from $6.1 million in Q1 2024, primarily due to reimbursements and lower costs [10] - Administrative expenses increased to $4.5 million in Q1 2025 from $2.4 million in Q1 2024, influenced by changes in employee share-based compensation [11] - The net loss from continuing operations was $(3.2) million for Q1 2025, a significant reduction from $(9.4) million in Q1 2024, with net loss per share improving from $(0.05) to $(0.02) [15][17] Pipeline and Development - Givastomig is a bispecific antibody targeting CLDN18.2-positive tumor cells, currently in Phase 1b trials for first-line metastatic gastric cancers [18][20] - The ongoing Phase 1b study is evaluating givastomig in combination with nivolumab and chemotherapy, with enrollment in the first dose expansion cohort completed ahead of schedule [20][21] - The company is also developing uliledlimab and ragistomig in collaboration with partners, with updates expected in 2026 [4][8]