I-Mab Reports Third Quarter 2024 Results

Core Insights - I-Mab is advancing its pipeline with promising data for its immunotherapy candidates, particularly uliledlimab and givastomig, as presented at major medical conferences [1][2][4][6] - The company appointed Dr. Sean Fu as the permanent CEO effective November 1, 2024, indicating a stable leadership transition [1][10] - I-Mab has a strong cash position of $184.4 million, expected to fund operations into 2027 [1][11] Pipeline Overview - Uliledlimab (CD73 antibody) is set to enter a randomized Phase 2 study in first-line metastatic non-small cell lung cancer (mNSCLC) in 1H 2025 [1][5] - Givastomig (Claudin 18.2 x 4-1BB bispecific antibody) is undergoing a Phase 1b study in combination with nivolumab plus chemotherapy for first-line metastatic gastric cancer, with topline data expected in 2H 2025 [5][8] - Ragistomig (PD-L1 x 4-1BB bispecific antibody) is in ongoing Phase 1 studies for advanced solid tumors [8] Clinical Data Highlights - Phase 1 data for uliledlimab showed full target engagement and a positive correlation between overall response rate (ORR) and drug exposure in mNSCLC patients [4] - Givastomig demonstrated an ORR of 16.3% in gastric cancer patients, with a favorable safety profile and no dose-limiting toxicities [6][7] - The optimal monotherapy dose range for givastomig was defined as 8-12 mg/kg, with ongoing studies supporting this dosage [6][7] Financial Performance - Research and development expenses for Q3 2024 were $4.5 million, a decrease from $5.1 million in Q3 2023, attributed to streamlined clinical activities [13] - Administrative expenses increased to $7.9 million in Q3 2024 from $5.9 million in Q3 2023, primarily due to legal costs [14] - The net loss from continuing operations was $(20.5) million for Q3 2024, compared to $(8.2) million in Q3 2023 [16] Strategic Developments - A collaboration agreement with Sanofi for uliledlimab in Greater China includes initial and milestone payments totaling approximately €32 million, with potential for up to €213 million in success-based milestones [10] - The company settled approximately $15 million in repurchase obligations related to its China operations, resulting in a 15% ownership in TJ Bio post-settlement [10]