I-MAB American Depositary Shares - IMAB STOCK NEWS

Genexine announced results from the KEYNOTE-899 phase 1b/2 clinical trial of GX-I7 (efineptakin alfa) with pembrolizumab. The trial demonstrated safety and early anti-tumor activity in patients with R/R metastatic TNBC. Overall response rates (ORR) were 15.7% in phase 1b and 21.2% in phase 2, with a notable 60% ORR in PD-L1 positive patients. CEO Neil Warma highlighted the potential of GX-I7 as a first-in-class treatment. Genexine is focusing on global development in multiple cancers with partners NeoImmune Tech and I-Mab.

I-Mab (Nasdaq: IMAB) has completed patient enrollment in the Phase 3 TALLER clinical trial for eftansomatropin alfa (TJ101), targeting pediatric growth hormone deficiency (PGHD) in China. The study enrolled 168 patients and aims to assess the efficacy and safety of the long-acting growth hormone compared to daily alternatives. Final data is expected in 2023, followed by a Biologics License Application submission. The company is collaborating with Jumpcan Pharmaceutical Group to expedite the commercialization of this novel therapy, addressing a significant unmet need in PGHD treatment.

I-Mab (Nasdaq: IMAB) announced promising preliminary data from its ongoing Phase 2 trial of uliledlimab, a CD73 antibody, combined with toripalimab for treating non-small cell lung cancer (NSCLC). Results showed a favorable safety profile with no dose-limiting toxicities and a 26% overall response rate in advanced NSCLC patients, particularly those with high CD73 expression. The company plans to initiate a Phase 3 study in 2023, aiming to evaluate uliledlimab's efficacy further and its role as a potential predictive biomarker.

Genexine, a clinical-stage biopharmaceutical company, announces the appointment of Neil Warma as President and CEO. With over 25 years of leadership in healthcare, Warma aims to enhance global drug development and commercialization. The company focuses on expanding its pipeline, particularly in immunotherapeutics and long-acting biologics, and plans to file several important BLAs in the next 1-3 years. Genexine is currently conducting over 20 clinical trials, including Phase 3 studies, with initial data expected soon, which could drive shareholder value.

I-Mab (Nasdaq: IMAB) will hold a conference call on May 27 at 8 a.m. EST to present preliminary data from its ongoing phase 2 clinical trial of uliledlimab (TJD5), a differentiated CD73 antibody. This compound aims to enhance anti-tumor immune responses in combination with established checkpoint therapies. The call will also outline the global clinical development plan for uliledlimab, which is positioned to potentially offer significant clinical benefits in immuno-oncology.

I-Mab (Nasdaq: IMAB) provided updates regarding its status under the Holding Foreign Companies Accountable Act (HFCAA) following the SEC's provisional identification of the company as a "Commission-Identified Issuer." This identification occurred after I-Mab filed its annual report on Form 20-F for FY 2021, which included an audit report the PCAOB could not fully inspect. While this does not lead to immediate delisting, continued identification for three years may result in prohibited trading in the U.S. I-Mab is engaging an independent auditor to comply with HFCAA requirements, aiming for completion in H2 2022.

I-Mab (Nasdaq: IMAB) announces key appointments to enhance its leadership team. Richard Yeh has been appointed as Chief Operating Officer, with over 25 years of experience in the biopharmaceutical industry, particularly in investor relations and strategic operations. Dr. John Hayslip joins as Chief Medical Officer, bringing nearly two decades of oncology expertise to accelerate clinical development. This strategic move aims to support I-Mab's ambition of becoming a leading global biopharmaceutical company, focusing on innovative therapies for immuno-oncology diseases.

I-Mab (Nasdaq: IMAB) announced a 180-day voluntary lock-up of shares by key shareholders including CBC Group and Hony Capital, effective March 31, 2022. This decision reflects the shareholders' confidence in I-Mab's transformation into a fully integrated biopharma company. The lock-up involves 51,226,814 ordinary shares, representing 26.8% of total outstanding shares. Concurrently, I-Mab will register approximately 37.7 million ordinary shares to satisfy contractual registration rights, while the shareholders express no intention to sell during the lock-up period.

I-Mab (Nasdaq: IMAB) reported strong financial results for 2021, achieving numerous clinical milestones, including key data readouts for lemzoparlimab, uliledlimab, and felzartamab. The company established a $315M strategic partnership with Jumpcan for eftansomatropin alfa, advancing its pipeline with 10 clinical-stage assets, primarily in Phases 2 and 3. I-Mab expects 3-4 BLA filings between 2023-2025, supported by a robust cash position of $671M. With ongoing global expansions, the company is positioned for significant growth in the biopharmaceutical sector.