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I-Mab Reports Third Quarter 2024 Results
IMABI-Mab(IMAB) Prnewswire·2024-11-14 12:00

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 184.4million,expectedtofundoperationsinto2027[1][11]PipelineOverview−Uliledlimab(CD73antibody)issettoenterarandomizedPhase2studyinfirst−linemetastaticnon−smallcelllungcancer(mNSCLC)in1H2025[1][5]−Givastomig(Claudin18.2x4−1BBbispecificantibody)isundergoingaPhase1bstudyincombinationwithnivolumabpluschemotherapyforfirst−linemetastaticgastriccancer,withtoplinedataexpectedin2H2025[5][8]−Ragistomig(PD−L1x4−1BBbispecificantibody)isinongoingPhase1studiesforadvancedsolidtumors[8]ClinicalDataHighlights−Phase1dataforuliledlimabshowedfulltargetengagementandapositivecorrelationbetweenoverallresponserate(ORR)anddrugexposureinmNSCLCpatients[4]−GivastomigdemonstratedanORRof16.3184.4 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 5.1millioninQ32023,attributedtostreamlinedclinicalactivities[13]−Administrativeexpensesincreasedto5.1 million in Q3 2023, attributed to streamlined clinical activities [13] - Administrative expenses increased to 7.9 million in Q3 2024 from 5.9millioninQ32023,primarilyduetolegalcosts[14]−Thenetlossfromcontinuingoperationswas5.9 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)millioninQ32023[16]StrategicDevelopments−AcollaborationagreementwithSanofiforuliledlimabinGreaterChinaincludesinitialandmilestonepaymentstotalingapproximately€32million,withpotentialforupto€213millioninsuccess−basedmilestones[10]−Thecompanysettledapproximately(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]