Dr. Robert Lenz, Ms. Xin Liu and Dr. Sean Cao appointed to the Board of DirectorsResearch and Development Committee established to accelerate innovation and long-term growthDr. Ken Takeshita appointed to the Scientific Advisory Board ROCKVILLE, Md., Aug. 25, 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 appointment of independent directors, Dr. R ...

ROCKVILLE, Md., Aug. 01, 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 pricing of an underwritten offering in the United States of 33,333,334 American Depositary Shares (ADSs) representing 76,666,668 ordinary shares at an offering price of $1.95 per ADS, for total gross proceeds of approximately $65 million. All of the ADSs to be sold in the off ...

Core Viewpoint - I-Mab has announced a definitive agreement to acquire 100% ownership of Bridge Health Biotech Co., Ltd., enhancing its capabilities in developing the bispecific antibody givastomig for cancer treatment [1][2][4] Acquisition Details - The acquisition involves an upfront payment of $1.8 million and non-contingent payments of $1.2 million through 2027, with potential future milestone payments of up to $3.875 million [4] - The transaction is expected to close in Q3 of 2025 [4] Givastomig Development - Givastomig is a bispecific antibody targeting Claudin 18.2-positive tumor cells, currently in development for first-line metastatic gastric cancers, with potential expansion into other solid tumors [5][10] - Recent Phase 1b data showed an 83% objective response rate (ORR) in selected doses for dose expansion cohorts, indicating promising anti-tumor activity [3][6][8] Strategic Importance - The acquisition strengthens I-Mab's intellectual property rights related to givastomig, reduces future milestone payments, and eliminates royalty obligations [2][7] - The CLDN18.2 parental antibody used in givastomig exhibits higher affinity to human CLDN18.2 compared to other antibodies, which may differentiate it as a best-in-class therapy [2][5] Clinical Trial Progress - Enrollment in the first dose expansion cohort has been completed ahead of schedule, with topline results expected in Q1 of 2026 [3][8]

Company Overview - I-Mab is a U.S.-based global biotech company focused on developing precision immuno-oncology agents for cancer treatment [2] - The company's leading pipeline product is givastomig, a bispecific antibody targeting Claudin 18.2, designed for treating Claudin 18.2-positive gastric cancers [2] - Givastomig activates T cells through the 4-1BB signaling pathway in the tumor microenvironment, showing strong tumor-binding and anti-tumor activity in Phase 1 trials [2] Upcoming Events - I-Mab's management will participate in the BTIG Virtual Biotechnology Conference on July 29-30, 2025 [1] - The conference will include a fireside chat and one-on-one meetings, starting at 10:00 AM ET on July 29, 2025 [1] - A webcast of the event will be available on the I-Mab website for 90 days following the conference [1]

Core Insights - I-Mab announced positive Phase 1b combination data for givastomig, showing a confirmed objective response rate (ORR) of 83% at selected doses for ongoing expansion studies [1][2][3] - The study demonstrated favorable tolerability and safety profile, with no Grade 3 or greater events for nausea and vomiting [2][21] - Givastomig is a bispecific antibody targeting Claudin 18.2 and 4-1BB, being developed for first-line treatment of Claudin 18.2-positive gastric cancers [15][18] Study Results - The Phase 1b study showed an overall ORR of 71% across all doses and 83% at doses selected for expansion (8 mg/kg and 12 mg/kg) [2][10] - Responses were observed in tumors with low PD-L1 and/or Claudin 18.2 expression, indicating broad potential for the therapy [2][3] - The disease control rate (DCR) was 100% across all dose levels, with a median follow-up of 9.0 months [12][13] Safety Profile - Treatment-related adverse events (TRAEs) leading to discontinuation were 12%, with common TRAEs being Grade 1 or 2 [21] - No dose-limiting toxicities (DLT) were observed, and a maximum tolerated dose (MTD) was not reached [21] - Grade 3 TRAEs were rare, with only isolated cases reported [21] Future Plans - I-Mab plans to host a virtual investor event on July 8 to discuss the Phase 1b data further [1][4] - The ongoing Phase 1b study is evaluating givastomig in combination with nivolumab and chemotherapy, with enrollment progressing ahead of schedule [16][18]

Core Insights - I-Mab announced the publication of first-in-human monotherapy data for givastomig, a bispecific Claudin 18.2 x 4-1BB antibody, showing an objective response rate (ORR) of 16% in heavily pretreated Claudin 18.2-positive gastric cancer patients [1][2][4] Summary of Monotherapy Results - The Phase 1 monotherapy study evaluated 75 patients, with 43 being efficacy-evaluable for advanced or metastatic gastroesophageal carcinoma (GEC) [2][5] - The ORR increased to 18% after the enrollment of two additional patients, resulting in 8 out of 45 patients achieving a confirmed partial response (PR) [2][6] - The study demonstrated a disease control rate (DCR) of 49% among the efficacy-evaluable patients [7] Safety and Tolerability - Givastomig was well tolerated, with no dose-limiting toxicity reported up to 15 mg/kg dosed every two weeks and 18 mg/kg dosed every three weeks [15] - The most common treatment-related adverse events were mainly Grade 1 or 2 [15] Development Strategy - The findings support the development of givastomig in combination with standard immunochemotherapy (nivolumab plus mFOLFOX6) as a first-line treatment for gastric cancers [3][4] - An ongoing Phase 1b study is evaluating givastomig in combination with nivolumab and chemotherapy, with enrollment progressing ahead of schedule [10] Unique Mechanism - Givastomig's bispecific design allows for high binding affinity to Claudin 18.2-positive cancer cells, enabling localized T cell stimulation while minimizing gastrointestinal toxicity [4][9]

Core Viewpoint - I-Mab is hosting a virtual investor event on July 8, 2025, to discuss new data on givastomig, a bispecific antibody targeting Claudin 18.2, following its presentation at ESMO GI 2025 [2][4] Group 1: Event Details - The event will feature Dr. Samuel J. Klempner, who will present new data on givastomig in combination with immunochemotherapy for Claudin 18.2-positive metastatic gastric cancers [3][4] - The data will be presented live at the ESMO GI 2025 on July 2, 2025, with a Mini Oral presentation scheduled for 16:50 CEST (10:50am EDT) [3] - A live Q&A session will follow the formal presentation, and a replay will be available on I-Mab's website for 90 days [4] Group 2: Givastomig Overview - Givastomig (TJ033721 / ABL111) is a bispecific antibody designed to target Claudin 18.2-positive tumor cells, activating T cells through the 4-1BB signaling pathway [6][9] - It is being developed for first-line treatment of metastatic gastric cancers, with potential applications in other solid tumors [6][9] - Phase 1 trials have shown promising anti-tumor activity while minimizing common toxicities associated with other 4-1BB agents [6][9] Group 3: Clinical Study Insights - An ongoing Phase 1b study is evaluating givastomig in combination with nivolumab and chemotherapy for first-line treatment of Claudin 18.2-positive metastatic gastric cancers [7] - The dose escalation phase is complete, and enrollment in the first dose expansion cohort (n=20) has finished ahead of schedule, with continued progress in the second cohort [7] - The study builds on positive Phase 1 monotherapy data, indicating strong potential for further development [7] Group 4: Company Background - I-Mab is a U.S.-based global biotech company focused on precision immuno-oncology agents for cancer treatment, with givastomig as a key product in its pipeline [9] - The company is jointly developing givastomig with ABL Bio, sharing worldwide rights except for Greater China and South Korea [8]

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]