[Translation] A phase II, randomized, multicenter, open-label study comparing ulelimab plus sintilimab and chemotherapy versus sintilimab plus chemotherapy in patients with previously untreated locally advanced, unresectable or metastatic non-small cell lung cancer

安全性导入期尤莱利单抗联合信迪利单抗和化疗的安全性和耐受性。在既往未接受过治疗的局部晚期不可切除或转移性NSCLC 受试者中，评估尤莱利单抗联合信迪利单抗和化疗与信迪利单抗联合化疗相比在延长无进展生存期（PFS）方面的获益。

[Translation]

Safety and tolerability of ulelimab combined with sintilimab and chemotherapy in the safety run-in phase. In subjects with previously untreated locally advanced unresectable or metastatic NSCLC, the benefit of ulelimab combined with sintilimab and chemotherapy was evaluated in terms of prolonging progression-free survival (PFS) compared with sintilimab combined with chemotherapy.

Start Date09 Jan 2025

Sponsor / Collaborator

I-MAB Biopharma (Shanghai) Co., Ltd.

NCT07005336

/ RecruitingPhase 2

A Phase II, Randomized, Multicenter, Open-Label Study to Compare Uliledlimab Combined With Sintilimab and Chemotherapy Versus Sintilimab Combined With Chemotherapy in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer

This is a Phase II, randomized, open-label, active-controlled, multicenter study to compare intravenous uliledlimab combined with sintilimab and chemotherapy versus sintilimab combined with chemotherapy in patients with previously untreated locally advanced unresectable or metastatic NSCLC who are not suitable for targeted therapies such as EGFR or ALK.
Eligible subjects will be randomly assigned in a 1:1 ratio to receive either uliledlimab combined with sintilimab and chemotherapy or sintilimab combined with chemotherapy. Enrolled subjects will first enter a safety run-in period. When at least 12 subjects have been randomly assigned to Group A and have received ≥ 1 dose of study drug (with a total of approximately 24 subjects), enrollment will be suspended for safety evaluation. The safety evaluation period will last 3 weeks, during which safety, tolerability, and PK data of uliledlimab combined with sintilimab and chemotherapy will be collected and evaluated by the Safety Review Committee (SRC). The SRC will decide through discussion whether to proceed to the next stage of randomized enrollment, whether additional subjects need to be enrolled for safety evaluation, or whether the study treatment should be terminated due to high safety risks. After the SRC reaches a unanimous resolution, enrollment will continue until a total of approximately 150 subjects are enrolled. All 150 subjects will be included in the final efficacy analysis. If 3 or more subjects experience Grade ≥ 3 treatment-related AEs that are unrelieved and lead to discontinuation of all study drugs during the safety run-in period, enrollment in the next stage will be terminated.

Start Date09 Jan 2025

Sponsor / Collaborator

I-Mab Biopharma (Hangzhou) Co., Ltd.

NCT06984588

/ RecruitingPhase 2/3

A Phase II/III, Randomized, Multicenter, Open-Label Study to Compare Uliledlimab Combined With Toripalimab, Toripalimab Monotherapy, and Pembrolizumab Monotherapy in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1- and CD73- Selected Non-Small Cell Lung Cancer

This is a Phase II/III, randomized, open-label, active-controlled, multicenter study to compare intravenous uliledlimab combined with toripalimab, toripalimab monotherapy, and pembrolizumab monotherapy in patients with previously untreated locally advanced unresectable or metastatic PD-L1-positive (tumor proportion score [TPS] ≥ 1%) and CD73-positive (TC/IC > 30%; TC/IC defined as the higher of either the proportion of CD73-positive tumor cells or the proportion of CD73-positive immune cells at any intensity [IHC1+ or above]) NSCLC who are not suitable for targeted therapies such as EGFR, ALK, etc.
The number of enrolled subjects with PD-L1 TPS ≥ 50% will be limited to approximately 60% of the total sample size to reflect the natural prevalence of advanced NSCLC.
Patients who have received adjuvant or neoadjuvant therapy other than immune checkpoint inhibitor treatments are allowed to participate in this study, provided that such treatments have been completed at least 12 months prior to the occurrence of recurrence or metastasis.
During the screening period, tumor samples will be collected in advance and tested by the central laboratory for PD-L1 expression levels using the PD-L1 IHC 22C3 pharmDx assay and CD73 expression levels using the CD73 antibody assay (immunohistochemistry). Previous PD-L1 testing results obtained using the PD-L1 IHC 22C3 pharmDx assay will be accepted. Patients with PD-L1 positive expression (TPS ≥ 1%) and high CD73 expression (TC/IC > 30%) will meet the inclusion criteria.
Patients who do not meet the eligibility criteria as judged by the investigator may be re-screened once.
Patients with non-squamous NSCLC will be required to confirm the absence of EGFR-sensitive mutations or ALK fusion; patients with unknown EGFR and ALK expression status will be required to undergo testing and provide clinical laboratory test results prior to study enrollment, and may be enrolled after relevant driver gene mutations are ruled out. Meanwhile, patients with other definite actionable driver gene alterations (such as: ROS1 fusions, RET fusions, NTRK1/2/3 fusions, BRAF V600E mutations, MET14 exon skipping mutations, etc.) will be excluded from this study. Controversial cases with actionable gene mutations will be submitted to the study expert panel for joint decision.
This study includes Phase II and Phase III stages. Approximately 150 subjects will be enrolled in the Phase II stage. Based on the evaluation of the efficacy, safety, PK, and PD results of the Phase II study, a decision will be made on whether to proceed to the Phase III study. Approximately 300 subjects will be enrolled in the Phase III stage.

Start Date28 Mar 2024

Sponsor / Collaborator

I-Mab Biopharma (Hangzhou) Co., Ltd.

100 Clinical Results associated with Uliledlimab

100 Translational Medicine associated with Uliledlimab

100 Patents (Medical) associated with Uliledlimab

News (Medical) associated with Uliledlimab

15 May 2025

·www.globenewswire.com

I-Mab Reports First Quarter 2025 Financial Results and Provides Business Update

Prioritization of givastomig as I-Mab’s lead program positions the Company for clinical progressNew givastomig combination data selected for mini-oral presentation at ESMO GI, being held July 2-5 in Barcelona, SpainStrong financial position supported by $168.6 million of cash and cash equivalents, and short-term investments as of March 31, 2025; provides runway into 2027, through expected clinical readouts for givastomig ROCKVILLE, Md., May 15, 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 financial results for the three months ended March 31, 2025, and highlighted recent pipeline progress and business updates. “2025 is off to a strong start for I-Mab. Designation of givastomig as our lead program has enabled us to unlock significant value for the Company by considerably accelerating our Phase 1b program, as we work to improve the care of patients with gastric cancers, which impact more than 250,000 people globally,” said Sean Fu, PhD, Chief Executive Officer of I-Mab. “Driven by study momentum and investigator interest, we have completed patient enrollment in the first of two Phase 1b dose expansion cohorts ahead of schedule. We expect to share data on both cohorts in 1H 2026. We believe the combination of significant progress in our givastomig program, substantial cash balance, streamlined operations, and new U.S.-based business model positions I-Mab to deliver for both patients and our investors.” Pipeline Overview and Anticipated Upcoming Milestones Upcoming anticipated milestones for givastomig (CLDN18.2 x 4-1BB bispecific), prioritized to be I-Mab’s lead program in January 2025: July 2025: Presentation of new givastomig dose escalation combination data on U.S. patients at the European Society of Medical Oncology (“ESMO”) Gastrointestinal (“GI”) Cancers Congress 2025, being held July 2-5 in Barcelona, SpainDetails of the ESMO GI Mini Oral Presentation:Title: Preliminary Safety and Efficacy of Givastomig, a Novel Claudin 18.2/4-1BB Bispecific Antibody, in Combination with Nivolumab and mFOLFOX in Metastatic Gastroesophageal Carcinoma (mGEC)Speaker: Samuel J. Klempner, MD, Associate Professor of Medicine, Massachusetts General HospitalPresentation Number: 388MODate and Time: Wednesday, July 2nd at 16:50 CEST (10:50am EST) 1H 2026: Presentation of data from givastomig dose expansion cohorts (n=40) Enrollment in the ongoing dose expansion study for givastomig is progressing ahead of schedule. In addition, the Company anticipates updates in 2026 for two programs being developed with its partners: uliledlimab (monoclonal antibody targeting CD73); and ragistomig (PD-L1 x 4-1BB bispecific). First Quarter 2025 Financial Results – In connection with the divestiture of its Greater China assets and business operations, I-Mab’s first quarter 2024 amounts have been recast to conform to the discontinued operations presentation. Additionally, certain non-recurring costs occurred during the first quarter of 2024 that impact quarter-over-quarter comparisons. Cash Position As of March 31, 2025, the Company had cash and cash equivalents, and short-term investments of $168.6 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 March 31, 2025, the Company had 187,818,796 ordinary shares issued and outstanding, representing the equivalent of 81,660,346 ADSs, assuming the conversion of all ordinary shares into ADSs. Research and Development Expenses Research and development expenses were $0.8 million for the three months ended March 31, 2025, compared to $6.1 million for the three months ended March 31, 2024. The decrease was primarily driven by reimbursements recognized under an existing collaboration agreement and lower contract research organization costs during the three months ended March 31, 2025. Administrative Expenses Administrative expenses were $4.5 million for the three months ended March 31, 2025, compared to $2.4 million for the three months ended March 31, 2024. Employee share-based compensation expenses during the three months ended March 31, 2024 were $4.8 million lower, primarily driven by forfeitures in connection with the divestiture of the Greater China assets and business operations. Additionally, legal expenses were $2.5 million lower during the three months ended March 31, 2025. Interest Income Interest income was $1.9 million for the three months ended March 31, 2025, compared to $0.7 million for the three months ended March 31, 2024. The increase was primarily attributable to higher interest rates earned on cash balances in 2025. Other Income (Expenses), Net Other income (expenses), net were $0.2 million for the three months ended March 31, 2025, compared to $(0.6) million for the three months ended March 31, 2024. Equity in Loss of Affiliates Equity in loss of affiliates was $1.0 million for the three months ended March 31, 2024 due to recognition of the employee stock ownership plan expenses from the Company's unconsolidated investee as a result of the divestiture of the Greater China assets and business operations. There was no equity in loss of affiliates for the three months ended March 31, 2025. Net Loss from Continuing Operations Net loss from continuing operations was $(3.2) million for the three months ended March 31, 2025, compared to $(9.4) million for the three months ended March 31, 2024. Net loss from continuing operations per share attributable to ordinary shareholders was $(0.02) for the three months ended March 31, 2025, compared to $(0.05) for the three months ended March 31, 2024. Net Loss from Discontinued Operations On April 2, 2024, the Company closed the China divestiture announced on February 7, 2024 (the “Transaction”). In accordance with ASC 205-20, 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. As a result, the Company recognized a loss from discontinued operations of $6.9 million for the three months ended March 31, 2024. Net Loss Net loss was $(3.2) million for the three months ended March 31, 2025, compared to $(16.3) million for the three months ended March 31, 2024. Net loss per share attributable to ordinary shareholders was $(0.02) for the three months ended March 31, 2025, compared to $(0.09) for the three months ended March 31, 2024. About Givastomig Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (“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 first line (“1L”) metastatic gastric cancers, with further potential in other solid tumors. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents. The ongoing 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, in dose escalation and dose expansion cohorts. Dose escalation is complete, and enrollment in the first dose expansion cohort (n=20) finished ahead of schedule. Enrollment continues to progress ahead of schedule in the second dose expansion cohort (n=20). 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. About I-Mab I-Mab (NASDAQ: IMAB) is a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer. I-Mab has established operations in the U.S. in Rockville, Maryland, and Short Hills, New Jersey. For more information, please visit https://www.i-mabbiopharma.com and follow us on LinkedIn and X. I-Mab Forward Looking Statements This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will”, “expects”, “believes”, “designed to”, “anticipates”, “future”, “intends”, “plans”, “potential”, “estimates”, “confident”, and similar terms or the negative thereof. I-Mab may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about I-Mab’s beliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the Company’s pipeline and clinical development of I-Mab’s drug candidates, including givastomig; the projected advancement of the Company’s portfolio and anticipated milestones and related timing; the Company's expectations regarding the impact of data from ongoing and future clinical trials; the Company’s expectations regarding its cash runway; the timing and progress of studies and trials (including with respect to the patient enrollment); the potential benefits of givastomig; and the availability of data and information from ongoing studies and trials. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: I-Mab’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab’s drug candidates; I-Mab’s ability to achieve commercial success for its drug candidates, if approved; I-Mab’s ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab’s reliance on third parties to conduct drug development, manufacturing and other services; and I-Mab’s limited operating history and I-Mab’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the “Risk Factors” section in I-Mab’s annual report on Form 20-F filed with the SEC on April 3, 2025 as well as the discussions of potential risks, uncertainties, and other important factors in I-Mab’s subsequent filings with the SEC. All forward-looking statements are based on information currently available to I-Mab. I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. I-Mab Investor & Media Contacts PJ KelleherLifeSci Advisors+1-617-430-7579pkelleher@lifesciadvisors.comIR@imabbio.com I-MabConsolidated Balance Sheets(Unaudited; All amounts in thousands, except for par value and share data) As of March 31, As of December 31, 2025 2024 Assets Current assets Cash and cash equivalents $53,597 $68,263 Short-term investments 115,025 105,135 Prepayments and other receivables 4,611 3,295 Total current assets 173,233 176,693 Property, equipment and software 188 201 Operating lease right-of-use assets 3,404 3,597 Investments at fair value, available-for-sale debt securities (amortized cost of $38,727) 30,824 30,824 Other non-current assets 1,292 1,365 Total assets $208,941 $212,680 Liabilities and shareholders’ equity Current liabilities Accruals and other payables $6,916 $7,638 Operating lease liabilities, current 835 816 Total current liabilities 7,751 8,454 Operating lease liabilities, non-current 2,849 3,066 Total liabilities 10,600 11,520 Shareholders’ equity Ordinary shares ($0.0001 par value, 800,000,000 shares authorized as of March 31, 2025 and December 31, 2024; 187,818,796 and 187,452,495 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively) 19 19 Treasury stock (5,881) (6,225)Additional paid-in capital 1,460,005 1,460,021 Accumulated other comprehensive income 33,387 33,384 Accumulated deficit (1,289,189) (1,286,039)Total shareholders’ equity 198,341 201,160 Total liabilities and shareholders’ equity $208,941 $212,680 I-MabConsolidated Statements of Comprehensive Loss(Unaudited; All amounts in thousands, except for share and per share data) Three Months Ended March 31, 2025 2024 Revenues Licensing and collaboration revenue $— $— Total revenues — — Expenses Research and development expenses(1) (777) (6,062)Administrative expenses(2) (4,489) (2,441)Total expenses (5,266) (8,503)Loss from operations (5,266) (8,503)Interest income 1,872 709 Other income (expenses), net 244 (587)Equity in loss of affiliates(3) — (1,038)Loss from continuing operations before income tax expense (3,150) (9,419)Income tax expense — — Loss from continuing operations (3,150) (9,419) Discontinued operations: Loss from operations of discontinued operations(4) — (6,898)Income tax expense — — Loss from discontinued operations — (6,898) Net loss (3,150) (16,317) Other comprehensive income (loss): Foreign currency translation adjustments, net of tax 3 1,025 Total comprehensive loss $(3,147) $(15,292) Weighted-average number of ordinary shares used in calculating net loss per share - basic and diluted 187,679,483 185,858,408 Net loss from continuing operations per share - basic and diluted $(0.02) $(0.05)Net loss from discontinued operations per share - basic and diluted $— $(0.04)Net loss per share - basic and diluted $(0.02) $(0.09) Net loss from continuing operations per ADS(5) - basic and diluted $(0.04) $(0.12)Net loss from discontinued operations per ADS(5) - basic and diluted $— $(0.09)Net loss per ADS(5) - basic and diluted $(0.04) $(0.21) (1) Includes share-based compensation expense of $0.1 million and $0.3 million for the three months ended March 31, 2025 and 2024, respectively. (2) Includes share-based compensation expense of $0.2 million and $(4.5) million for the three months ended March 31, 2025 and 2024, respectively. The three months ended March 31, 2024 includes forfeitures as a result of divestiture of the Greater China assets and business operations and organizational changes. (3) Includes share-based compensation expense of $(0.7) million for the three months ended March 31, 2024, which includes forfeitures as a result of divestiture of the Greater China assets and business operations. (4) Includes share-based compensation expense of $(11.6) million for the three months ended March 31, 2024, which includes forfeitures as a result of divestiture of the Greater China assets and business operations. (5) Each 10 ADSs represents 23 ordinary shares.

Phase 1Financial StatementImmunotherapyPhase 2

06 Jan 2025

·www.fiercebiotech.com

I-Mab pauses Sanofi-partnered prospect to make play for busy CLDN18.2 space

I-Mab’s decision to pause work on uliledlimab comes months after Sanofi paid $36 million for Chinese rights.\n I-Mab has begun the new year with a pipeline pivot, pausing work on an asset Sanofi bought into last year to focus on its play for the congested CLDN18.2 space.Uliledlimab is the asset I-Mab has put on the back burner. The anti-CD73 antibody was the biotech’s lead candidate. But rather than advance into a phase 2 lung cancer trial, as I-Mab proposed in November, the company is pausing development to focus resources on its new lead program. I-Mab left the door open to further development of uliledlimab if the molecule impresses in studies run by its partners in China.For now, I-Mab is focused on the CLDN18.2x4-1BB bispecific givastomig. The biotech shared phase 1 monotherapy data on the candidate last year, reporting results management said suggest the asset hits the sweet spot for efficacy and tolerability.I-Mab reported a 16.3% response rate in 43 patients who received one of two monotherapy doses in a phase 1 trial. The biotech now has early tolerability data from a study that is testing givastomig with Bristol Myers Squibb’s checkpoint inhibitor Opdivo. I-Mab is yet to see dose-limiting toxicities or reach the maximum tolerated dose in the combination study. Encouraged by the data, the biotech is growing the dose-expansion stage of the study. The trial will now enroll 40 patients across two dose cohorts. People with tumors that express CLDN18.2 at 1+ intensity in 1% or more cells are eligible for the trial. Astellas’ anti-CLDN18.2 antibody Vyloy is approved for use in patients with moderate-to-strong, 2+ to 3+ intensity, membranous staining in at least 75% of tumor cells.Showing efficacy in CLDN18.2-low patients would differentiate givastomig from Vyloy, potentially helping I-Mab overcome Astellas’ head start. I-Mab is far from the only company gunning for Vyloy, though. The CLDN18.2 race features a clutch of bispecifics and antibody-drug conjugates (ADCs) aimed at the target. Activating T cells through the 4-1BB pathway differentiates givastomig from CLDN18.2xCD3 bispecifics such as AstraZeneca’s AZD5863. Other 4-1BB drugs have been associated with toxicities, but givastomig’s design—which limits activation to places where CLDN18.2 is expressed—could minimize those problems. I-Mab is pitching givastomig as a candidate that is more effective and tolerable than Vyloy and free from the cytokine release syndrome associated with T-cell engagers. Developers of ADCs such as AstraZeneca’s CMG901 have seen higher response rates offset by more grade 3 or worse adverse events. The risk-benefit profile could limit ADCs to later lines of use. I-Mab wants to take givastomig into first-line settings. The biotech is pulling back from other programs to pursue that vision, ensuring its existing cash will keep it going beyond dose-expansion readouts next year and into 2027.I-Mab’s decision to sacrifice uliledlimab, at least temporarily, to advance givastomig comes months after Sanofi paid $36 million for Chinese rights to the anti-CD73 antibody. TJ Biopharma, an I-Mab spinout, inked the deal with Sanofi.

Phase 1ADCPhase 2Drug ApprovalClinical Result

06 Jan 2025

·www.prnewswire.com

I-Mab Announces Portfolio Prioritization of Givastomig (CLDN18.2 x 4-1BB Bispecific Antibody) as Lead Clinical Program

Givastomig: a Claudin 18.2 ("CLDN18.2") x 4-1BB bispecific antibody, will be the lead clinical program following the Company's portfolio prioritization The Company has completed enrollment of a dose escalation study of givastomig in combination with nivolumab plus chemotherapy, and data is expected in the early second half of 2025; a 40-patient dose expansion study is now underway with data expected in early 2026 Cash balance of $184.4 million (as of September 30, 2024), expected to support operations into 2027, complemented by a strengthened U.S.-based leadership team and streamlined operating model ROCKVILLE, MD, Jan. 6, 2025 /PRNewswire/ -- 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 highlighted its strategic outlook for 2025 and a re-prioritization of resources, with a focus on advancing its lead program, givastomig, a CLDN18.2 x 4-1BB bispecific antibody, targeting first-line metastatic gastric cancers, with further potential in other solid tumors. "I-Mab made excellent progress executing its corporate strategy in 2024, including the establishment of a new operating model as a U.S.-based global biotech company, completion of the divestiture of operations in China, including extinguishment of all remaining redemption obligations, appointment of U.S.-based auditors, enhanced transparency through quarterly financial reporting, and buildout of a U.S.-based leadership team," said Sean Fu, PhD, MBA, CEO and Board Member of I-Mab. "Building on this positive momentum, the Company has implemented a portfolio prioritization to support the accelerated development of givastomig." Portfolio Prioritization 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 first-line metastatic gastric cancers, with additional potential in other solid tumors. In Phase 1 trials, givastomig was observed to maintain a strong tumor-binding property and anti-tumor activity, attributable to a potential synergistic effect of proximal interaction with CLDN18.2 and 4-1BB, while minimizing toxicities commonly seen with other 4-1BB agents. The Company will focus its resources on advancing givastomig as its lead asset. Topline Phase 1 monotherapy dose escalation and dose expansion data presented at the annual meeting of the European Society for Medical Oncology ("ESMO 2024") showed: An overall response rate ("ORR") of 16.3% (7/43), including seven partial responses ("PR") at doses between 5 mg/kg and 18 mg/kg, with five of the seven responders (71%) having received prior checkpoint inhibitor ("CPI") therapy. A favorable safety profile, with mainly grade 1 or 2 treatment-related adverse events ("TRAEs"). No dose-limiting toxicities ("DLTs") were observed, and a maximum tolerated dose ("MTD") was not identified. A Phase 1b dose escalation study of givastomig in combination with nivolumab plus chemotherapy has been fully enrolled (n = 17) with no MTD reached and no DLTs to date; the Company expects to present these data in the early second half of 2025 . Based on encouraging early data from the dose escalation study, the Company is expanding the previously planned dose expansion cohort (n = 6-8) to include two dose cohorts, each evaluating 20 patients, for a total of 40 patients. Patients are being enrolled with tumors that express CLDN18.2 as low as 1+ intensity in ≥1% of cells, regardless of PD-L1 expression The Company expects to share these data in early 2026. This program is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding China and South Korea, equally with ABL Bio. According to Phillip Dennis, MD, PhD, CMO of I-Mab, "Data arising from this study will not only help establish the breadth of patients who might respond to this novel regimen (such as those with low levels of CLDN18.2 expression that would not qualify for approved CLDN18.2 therapies), but also help establish the recommended dose of givastomig for subsequent studies." Uliledlimab (TJ004309) is an antibody designed to target CD73, the rate-limiting enzyme critical for adenosine-driven immunosuppression in the tumor microenvironment. I-Mab owns worldwide rights to uliledlimab outside of Greater China. The development of uliledlimab is being paused to allow the Company to focus resources toward advancing its lead clinical program, givastomig, and to allow data to mature from an ongoing China-only randomized study conducted by its partner TJ Biopharma evaluating uliledlimab in combination with a CPI (toripalimab) in CD73-high NSCLC patients. As a result, further clinical investment in uliledlimab will be put on hold. The Company will continue to monitor data as it becomes available. I-Mab is positioned to potentially resume clinical development, pending positive data. Ragistomig (TJ-L14B / ABL503) is a bispecific, Fc-silent antibody designed to provide anti-PD-L1 activity and conditional 4-1BB-driven T-cell activation in one molecule. Ragistomig is being developed for solid tumors that are refractory or have relapsed after exposure to CPIs. The program is being jointly developed through a global partnership with ABL Bio, in which ABL Bio is the lead party and shares worldwide rights, excluding China and South Korea, equally with I-Mab. Data reported by ABL Bio at the annual meeting of the American Society of Clinical Oncology ("ASCO 2024") showed promising objective responses in patients with various solid tumors whose tumors progressed or recurred after prior standard treatments, including patients with prior exposure to PD-(L)1 inhibitors. ABL Bio is continuing the Phase 1b study to increase the therapeutic index by altering the dosing level and/or frequency, and to identify the appropriate tumor types for further development. Financial Outlook The Company's current cash position is expected to fund the givastomig Phase 1b study through dose expansion data readouts and further development initiatives into 2027. About I-Mab I-Mab (NASDAQ: IMAB) is a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer. I-Mab has established operations in the U.S. in Rockville, Maryland, and Short Hills, New Jersey. For more information, please visit us at: and follow us on LinkedIn and X. I-Mab Forward Looking Statements This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will", "expects", "believes", "designed to", "anticipates", "future", "intends", "plans", "potential", "estimates", "confident", and similar terms or the negative thereof. I-Mab may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the "SEC"), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about I-Mab's beliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the Company's pipeline and capital strategy; the projected advancement of the Company's portfolio and anticipated milestones and related timing; the Company's expectations regarding its cash runway; timing and progress of studies and trials; and the availability of data and information from ongoing studies and trials. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; and I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the SEC. All forward-looking statements are based on information currently available to I-Mab. I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. I-Mab Investor & Media Contacts SOURCE I-Mab Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1ASCOImmunotherapyClinical Result

100 Deals associated with Uliledlimab

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	I-Mab Biopharma (Hangzhou) Co., Ltd.	28 Mar 2024
Non-small cell carcinoma	Phase 3	China	I-MAB Biopharma (Shanghai) Co., Ltd.	27 Mar 2024
Non-Small Cell Lung Cancer	Phase 3	China	I-MAB Biopharma (Shanghai) Co., Ltd.	27 Mar 2024
Gastrointestinal Neoplasms	Phase 2	United States	I-Mab Biopharma US Ltd.	02 Nov 2021
Head and Neck Neoplasms	Phase 2	United States	I-Mab Biopharma US Ltd.	02 Nov 2021
Metastatic gastroesophageal adenocarcinoma	Phase 2	United States	I-Mab Biopharma US Ltd.	02 Nov 2021
metastatic non-small cell lung cancer	Phase 2	United States	I-Mab Biopharma US Ltd.	02 Nov 2021
Ovarian Cancer	Phase 2	United States	I-Mab Biopharma US Ltd.	02 Nov 2021
Ovarian Epithelial Carcinoma	Phase 2	United States	I-Mab Biopharma US Ltd.	02 Nov 2021
Platinum-Resistant Ovarian Carcinoma	Phase 2	United States	I-Mab Biopharma US Ltd.	02 Nov 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04322006 (ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	Non-Small Cell Lung Cancer First line PD-L1 High Expression \| CD73 High Expression	66	Toripalimab+Uliledlimab	lcacdqkekj(blhkgqoocb) = iilmelftcx remgdszxrj (hfmzpoxasl ) View more	Positive	31 May 2023
NCT04322006 (ASCO 12023 \| ASCO 22023) Manual	Phase 1/2		66	Toripalimab+Uliledlimab (D73High pts)	lcacdqkekj(blhkgqoocb) = fjbkpmfayx remgdszxrj (hfmzpoxasl )	Positive	31 May 2023
NCT04322006 (ASCO2022) Manual	Phase 1/2	Advanced Malignant Solid Neoplasm	92	Uliledlimab (dose escalation)	qbowyqiocn(yvywarvfvr) = qkzcdmpjfz ybxmjewjov (zxbhdqekqx )	Positive	02 Jun 2022
NCT04322006 (ASCO2022) Manual	Phase 1/2	Advanced Malignant Solid Neoplasm	92	Uliledlimab+Toripalimab (dose escalation)	qbowyqiocn(yvywarvfvr) = qjblzphjer ybxmjewjov (zxbhdqekqx )	Positive	02 Jun 2022
NCT04322006 (Corporate Publications) Manual	Phase 2	Non-Small Cell Lung Cancer CD73 Overexpression	19	Uliledlimab (Patients with advanced NSCLC (mostly stage 4 lung cancer) who are not eligible for standard treatment)	wvvmahqcsv(ihqnwgowki) = fefvjfujgc gfdvlxzwvv (qqojvngaoa ) View more	Positive	27 May 2022
NCT03835949 (ASCO 12021 \| ASCO 22021) Manual	Phase 1	Advanced cancer CD73 Overexpression	20	uliledlimab+atezolizumab	zsnmzubmww(zzlmiaaxql) = none kggpqxxeob (johkgwrugt ) View more	Positive	28 May 2021

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis