I-Mab Shifts Strategic Focus to Gastric Cancer Therapy Givastomig, Market Evaluates New Trajectory
I-Mab has undergone a significant strategic pivot, divesting its original China portfolio and revamping its leadership to concentrate efforts on givastomig, a promising gastric cancer treatment. This shift aims to unlock long-term value, though the market's full appreciation of this new direction is still developing.
I-Mab (NASDAQ: IMAB), a U.S.-based global biotechnology company, has announced a significant strategic realignment, divesting its original China portfolio and implementing a comprehensive leadership overhaul to concentrate its resources on the development of givastomig, a bispecific antibody targeting Claudin 18.2 and 4-1BB for gastric cancer. This pivot follows a transformative period for the company in the first half of 2025, culminating in positive clinical data presentations and a strengthened financial position.
The Strategic Realignment and Clinical Progress
I-Mab's strategic shift centers on givastomig, which is designed to conditionally activate T cells in the tumor microenvironment of Claudin 18.2-positive gastric cancers. This focus comes after the company streamlined its operations by divesting its non-core China assets, aiming for a more concentrated and efficient development pathway. The company's leadership has also been revamped to steer this new direction.
The cornerstone of this new strategy is the clinical advancement of givastomig. At the European Society for Medical Oncology Gastrointestinal Cancers Congress (ESMO GI) 2025, I-Mab presented compelling Phase 1b dose escalation data. In combination with immunochemotherapy, givastomig demonstrated an objective response rate (ORR) of 83% (10 out of 12 patients) at selected doses of 8 mg/kg and 12 mg/kg. These responses were characterized as rapid, durable, and deepening over time, accompanied by a favorable overall safety profile. The overall ORR in the combination study was reported at 71%. Earlier Phase 1 monotherapy data showed an ORR of 16% in heavily pretreated Claudin 18.2-positive gastric cancer patients, with no dose-limiting toxicity observed. While specific safety data from the combination study indicated that 24% of patients experienced Grade 3 neutropenia and 12% experienced Grade 4 neutropenia, no dose-limiting toxicity was reported.
I-Mab, in global partnership with ABL Bio, where I-Mab holds the lead role and shares worldwide rights outside Greater China and South Korea, has rapidly advanced givastomig development. The company recently completed enrollment for the planned Phase 1b dose expansion study, which evaluates givastomig in combination with nivolumab and mFOLFOX6 for first-line metastatic gastric cancers, ahead of schedule.
Market Reaction and Financial Position
Investors have begun to acknowledge I-Mab's strategic pivot, with the stock, IMAB, experiencing a notable increase of over 440% year-to-date. This surge suggests growing optimism regarding the potential of givastomig and the company's revitalized focus. Despite this significant appreciation, some analyses suggest that the market may still be underestimating the full potential value of I-Mab's new trajectory, particularly given the large market opportunity in gastric cancer.
Financially, I-Mab has strengthened its balance sheet. Following an August 2025 underwritten offering, the company secured approximately $61.2 million in net proceeds. This boosted its pro-forma cash balance to approximately $226.8 million as of June 30, 2025, after accounting for the offering. This cash position is projected to provide a financial runway to fund planned operating expenses and capital expenditures through the fourth quarter of 2028, including resources for a randomized Phase 2 trial of givastomig. The company also reported reduced research and development (R&D) expenses of $3.3 million for Q2 2025, down from $5.2 million in Q2 2024, alongside a net loss of $5.5 million for Q2 2025.
Broader Context and Competitive Landscape
I-Mab's entry into the competitive gastric cancer treatment landscape positions givastomig against therapies from established pharmaceutical entities. Key competitors include Amgen's (AMGN) Bemarituzumab, AstraZeneca's (AZN) Rilvegostomig, and Arcus Biosciences (RCUS)/Gilead Sciences' (GILD) domvanalimab. While the 83% ORR reported for givastomig in its expansion cohort is significant, analysts will closely monitor how it compares to its peers as more extensive data emerges.
This strategic pivot places I-Mab firmly within the Biotechnology Sector and Pharmaceutical Sector, where innovation and successful clinical development are paramount for long-term value creation. The move to concentrate on a single, high-potential asset like givastomig allows the company to minimize resource dispersion and maximize the probability of success for its lead candidate.
Looking Ahead
The immediate focus for I-Mab and its investors will be the release of topline data from the Phase 1b dose expansion study of givastomig in combination with nivolumab and mFOLFOX6 for first-line metastatic gastric cancers. The company anticipates presenting these crucial data in Q1 2026. This upcoming milestone is expected to be a key catalyst for the stock, providing further clarity on givastomig's efficacy and safety profile in a broader patient population. Future developments for other programs like ragistomig and uliledlimab, currently under development by ABL Bio and TJ Biopharma respectively, are anticipated in 2026. The success of givastomig remains central to I-Mab's redefined corporate strategy and its ability to deliver on its promise of value creation for shareholders and patients.
