On April 3, 2025 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, reported financial results for the full year ended December 31, 2024, and highlighted recent pipeline progress and business updates (Press release, I-Mab Biopharma, APR 3, 2025, View Source [SID1234651786]).
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"The last year has been transformational for I-Mab. We successfully established a new model as a U.S.-based biotech company, divested all business operations in China, redefined our strategy, strengthened our leadership team, reprioritized our pipeline and accelerated the development of our lead program, givastomig, a novel Claudin-18.2 targeted therapy," said Sean Fu, PhD, MBA, CEO and board member of I-Mab. "We believe givastomig is uniquely situated to be a potential best-in-class, Claudin-18.2 therapy, with broad applicability in gastric cancer and beyond, and our strong cash balance positions us to build on the momentum."
2024 Selected Finance and Corporate Development Highlights:
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Appointment of Sean (Xi-Yong) Fu, PhD, MBA, as Chief Executive Officer.
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Completed divestiture of Greater China assets and business operations, including settlement of all non-participating shareholder redemption obligations.
Pipeline Overview and Potential Upcoming Milestones
In January 2025, the Company announced a portfolio re-prioritization, with a focus on advancing its lead program, givastomig, a CLDN18.2 x 4-1BB bispecific antibody, targeting first-line (1L) metastatic gastric cancers, with further potential in other solid tumors. The Company continues to monitor development of uliledlimab, an antibody designed to target CD73, the rate-limiting enzyme critical for adenosine-driven immunosuppression in the tumor microenvironment, in Phase 2 studies with its partner, TJ Biopharma, and support ongoing studies underway with its partner, ABL Bio, for ragistomig, a bispecific, Fc-silent antibody designed to provide anti-PD-L1 activity and conditional 4-1BB-driven T-cell activation in one molecule.
Givastomig
Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting CLDN18.2-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for 1L metastatic gastric cancers, with further potential in other solid tumors. In Phase 1 trials, givastomig was observed to maintain a strong tumor-binding property and promising anti-tumor activity, attributable to a potential synergistic effect of proximal interaction between CLDN18.2 and 4-1BB, while minimizing toxicities commonly seen with other 4-1BB agents.
Enrollment recently completed in the first dose expansion cohort (n=20), ahead of schedule, with continued momentum in the second dose expansion cohort (n=20). The Phase 1b study is evaluating givastomig for the treatment of gastric cancer in the 1L setting in combination with standard of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy. The study builds on positive Phase 1 monotherapy data.
Givastomig is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.
Upcoming Phase 1b Givastomig Milestones:
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2H 2025: Phase 1b dose escalation data (n=17) expected to be presented at a medical meeting.
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1H 2026: Expected topline results from the ongoing dose expansion study (n=40).
Full Year 2024 Financial Results
Cash Position
As of December 31, 2024, the Company had cash, cash equivalents, and short-term investments of $173.4 million. The Company’s current cash position is expected to fund the givastomig Phase 1b study through anticipated dose expansion data readouts and further development initiatives into 2027.
Shares Outstanding
As of December 31, 2024, the Company had 187,452,495 ordinary shares issued and outstanding, representing the equivalent of 81,501,085 ADSs, assuming the conversion of all ordinary shares into ADSs.
Research & Development Expenses
Research and development expenses were $21.8 million for the year ended December 31, 2024, compared to $21.4 million for the year ended December 31, 2023. The increase was primarily attributable to an increase in givastomig-related spending, partially offset by a decrease of $1.9 million in employee-related expenses due to lower headcount and a decline in stock price.
Administrative Expenses
Administrative expenses were $29.7 million for the year ended December 31, 2024, compared to $28.2 million for the year ended December 31, 2023. The increase was primarily attributable to an increase in professional services fees of $13.8 million due to an increase in legal expenses associated with certain trade secret misappropriation disputes against Inhibrx, Inc. This increase was partially offset by a decrease in employee-related expenses of $12.4 million due to the forfeiture of shares as a result of the divestiture of the Greater China assets and business operations and a decline in stock price, as well as exits of certain executive employees.
Interest Income
Interest income was $7.5 million for the year ended December 31, 2024, compared to $9.3 million for the year ended December 31, 2023. The decrease was primarily attributable to lower average investable cash balances.
Other Expenses, Net
Other expenses, net were $4.7 million for the year ended December 31, 2024, compared to $8.1 million for the year ended December 31, 2023. The change was primarily attributable to the fair value changes and extinguishment of put right liabilities and a smaller impact from foreign exchange losses, partially offset by expenses recognized on the settlement of non-participating shareholder redemption obligations and fixed asset impairments.
Equity in Loss of Affiliates
Equity in loss of affiliates was $1.0 million for the year ended December 31, 2024, compared to $11.4 million for the year ended December 31, 2023. The decrease was driven by no further recognition of allocated losses from our unconsolidated investee, as the investee no longer qualified for equity method accounting after the first quarter of 2023, and a decline in employee stock ownership plan expenses through the first quarter of 2024 prior to the transfer of our shares in the unconsolidated investee to certain participating shareholders in connection with the divestiture of the Greater China assets and business operations.
Net Loss from Continuing Operations
Net loss from continuing operations was $(49.7) million for the year ended December 31, 2024, compared to $(82.2) million for the year ended December 31, 2023. Net loss from continuing operations per share attributable to ordinary shareholders was $(0.27) for the year ended December 31, 2024 compared to $(0.43) for the year ended December 31, 2023.
Net Loss from Discontinued Operations
On April 2, 2024, the Company closed the China divestiture announced on February 7, 2024 (the "Transaction"). The Company determined that the Transaction represented a strategic shift that had a major effect on the business and therefore, met the criteria for classification as discontinued operations at December 31, 2024. Accordingly, the carrying value of in-process research and development and the net assets associated with the Greater China business operations are reported as discontinued operations in accordance with ASC 205-20, Discontinued Operations. Amounts applicable to prior years have been recast to conform to the discontinued operations presentation. The Company recognized a gain on the Transaction in the amount of $34.4 million for the year ended December 31, 2024, and a loss from operations of the discontinued component of $6.9 million for the year ended December 31, 2024.
Net Loss
Net loss was $(22.2) million for the year ended December 31, 2024, compared to $(207.7) million for the year ended December 31, 2023. Net loss per share attributable to ordinary shareholders was $(0.12) for the year ended December 31, 2024 compared to $(1.09) for the year ended December 31, 2023.