ROCKVILLE - I-Mab (Nasdaq: IMAB) (the 'Company'), is a global biotechnology company focused on bringing highly differentiated medicines to patients around the world through the discovery, development, and commercialization of novel immunotherapies and biologics for oncology, today announced its financial results for the six months ended June 30, 2023, and provided key business updates.

I-Mab has made significant progress in advancing its pipeline of innovative assets over the last eight months.

'2023 is off to a great start with promising early results from our two lead oncology programs, uliledlimab, and givastomig, coupled with new, positive Phase 3 eftansomatropin alfa results, thanks to the diligent efforts of our employees. As we move forward, we plan to focus on three strategic pillars: prioritizing two promising clinical assets in oncology to advance in the US, maintaining our strong balance sheet, and focusing on establishing a new operating model to become a US-based global biotech company,' said Raj Kannan, Chief Executive Officer of I-Mab.

H1 2023 Key Clinical Program Highlights

Uliledlimab (CD73 mAb): Encouraging clinical and translational data presented at ASCO 2023

Uliledlimab is a highly differentiated CD73 antibody which can completely inhibit CD73 enzymatic activity without causing the aberrant pharmacological property known as the 'hook effect.' Results from an ongoing Phase 2 study of uliledlimab in combination with toripalimab, a PD-1 inhibitor, showed a favorable safety profile and an encouraging objective response rate (ORR) of 31% (21/67) in the overall population regardless of CD73 and PD-L1 expression. In this study, without concomitant chemotherapy, in patients whose tumors expressed higher levels of CD73 and had a PD-L1 tumor proportion score (TPS) of >1%, the observed ORR was 63% (10/16).

Next steps: The clinical program is currently focused on non-small cell lung cancer (NSCLC) and ovarian cancer. Enrollment in the Phase 2 study of uliledlimab with toripalimab for patients with ovarian cancer is ongoing in China. In the US, I-Mab plans to submit an IND for uliledlimab in combination with chemotherapy and checkpoint inhibitors in newly diagnosed patients with advanced NSCLC in H1 2024.

Givastomig (Claudin 18.2 x 4-1BB bispecific Ab): Phase 1 trial data and publication highlight potential for a differentiated program

Encouraging initial Phase 1 results: Givastomig was designed as a bispecific antibody to target Claudin 18.2-positive tumor cells and stimulate pro-immune 4-1BB signaling. Phase 1 dose escalation has reached the highest planned dose level. Most treatment-related adverse events have been low-grade. In this study, encouraging findings of monotherapy efficacy were observed, including in tumors with lower levels of Claudin 18.2 expression, in patients with previously treated cancer that has relapsed or progressed after prior standard treatments.

Preclinical data on this program were published in the July 2023 issue of the Journal of Immunotherapy of Cancer, and the Phase 1 monotherapy dose escalation data were selected for presentation at the European Society of Medical Oncology (ESMO) in October 2023. An expansion cohort of patients with Claudin 18.2 positive gastric, gastroesophageal junction (GEJ), and esophageal cancer whose disease has progressed after previous treatment is enrolling, and interim results are expected in H1 2024.

Based upon these encouraging signals, dose escalation is expected to begin in combination with standard chemotherapy and immunotherapy regimens for patients with treatment naive gastric, GEJ, and esophageal cancer in the US, Japan, and China in H1 2024.

The program is being developed in collaboration with ABL Bio.

TJ-L14B/ABL503 (PD-L1 x 4-1BB bispecific antibody): Phase 1 Dose Expansion initiated in H1 2023

TJ-L14B/ABL503 was designed to treat PD-(L)1 antibody-resistant tumors. The antibody acts by inducing conditional activation of 4-1BB when it binds to its target, PD-L1. A Phase 1 dose-escalation study is underway in patients with progressive, locally advanced or metastatic solid tumors who are relapsed or refractory following prior lines of treatment. A preliminary efficacy signal has been observed, and a maximally tolerated dose (MTD) has not yet been reached. The dose expansion portion of the Phase 1 study is underway in the US and South Korea. The program is also being developed in collaboration with ABL Bio.

New Data: Eftansomatropin alfa (long-acting recombinant human growth hormone)

I-Mab today announced positive topline results from its multi-center, randomized, open-label, active-controlled pivotal phase 3 study (CTJ101PGHD301) evaluating the efficacy and safety of eftansomatropin alfa in children with growth hormone deficiency.

The study met its primary endpoint of annualized height velocity (AHV) at week 52 and demonstrated that eftansomatropin alfa was non-inferior to Norditropin. Eftansomatropin alfa was given by weekly injection vs. Norditropin given by daily injection. The mean AHV was 10.76 (cm/year) for eftansomatropin alfa vs. 10.28 (cm/year) for Norditropin, with a difference of 0.47 [95% CI -0.06,1.00] and non-inferiority p-value

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