On August 31, 2020 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported financial results for the six months ended June 30, 2020 and provided an overview of recent highlights and upcoming milestones (Press release, I-Mab Biopharma, AUG 31, 2020, View Source [SID1234564204]).
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"I-Mab continues to advance our robust pipeline, create value through innovation, and is well positioned to become a fully integrated global biopharmaceutical company. The differentiation of our innovative assets has become validated as the clinical trials progress, as exemplified by our positive preliminary clinical results for lemzoparlimab," said Dr. Jingwu Zang, Founder, Honorary Chairman and Director of I-Mab. "Looking ahead, we remain excited and confident in our science and increasing capabilities to deliver the promised corporate and pipeline development milestones and create value for patients as well as for our shareholders."
The Company expects multiple data readouts across a progressing pipeline in the coming months. These include the clinical results of phase 1 clinical trial in the U.S. and China for lemzoparlimab, initial data from uliledlimab (TJD5), the differentiated CD73 antibody, Part 2 clinical update from plonmarlimab in patients with cytokine release syndrome associated with severe COVID-19, as well as phase 2 results from olamkicept (TJ301) in patients with ulcerative colitis. Felzartamab (TJ202), the Company’s in-licensed CD38 antibody, is being evaluated in two parallel registrational studies in China for the treatment of multiple myeloma and is on track for subject enrollment.
In addition, the Company’s recent appointment of Chief Commercial Officer Ivan Yifei Zhu marks the Company’s commitment to building commercial capability and executing our commercialization plans for upcoming product launches. The remarkable progress in pipeline and corporate development demonstrated during this period significantly strengthens the Company’s position to achieve longer-term growth into 2021 and beyond.
Recent Highlights and Upcoming Milestones
Internally Discovered Global Pipeline
TJC4 or lemzoparlimab (differentiated anti-CD47):
– Clinical development in the U.S.: Lemzoparlimab is one of the leading drug candidates among I-Mab’s proprietary and innovative pipeline. It is designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity, a critical attribute in differentiating lemzoparlimab from some other antibodies of the same class currently in development. The topline results of the recently completed phase 1 dose-escalation clinical trial in the U.S. have demonstrated the differentiated profile of lemzoparlimab in drug safety and favorable pharmacokinetics in cancer patients. The results have shown that lemzoparlimab is well tolerated as a single agent at a dose range of up to 30 mg/kg without introducing any priming dosing strategy. In all DLT-evaluable patients, no dose-limiting toxicities or severe hematologic adverse events were observed. Detailed data will be released separately and presented at an appropriate scientific conference later this year. The on-going U.S. study has proceeded into a combination trial with PD-1 inhibitor pembrolizumab (KEYTRUDA) in cancer patients with several types of solid tumors through a collaboration with Merck Sharp & Dohme Corp (MSD) and Rituximab (RITUXAN) in patients with Non-Hodgkin’s lymphoma (NHL).
– Clinical development in China: Lemzoparlimab is being evaluated in a Phase 1/2a clinical trial in patients with relapsed or refractory acute myeloid leukemia (r/r AML) or myelodysplastic syndrome (MDS) in China. Results are expected in early 2021.
TJD5 or uliledlimab (differentiated anti-CD73):
– Clinical development in the U.S.: TJD5 is being evaluated in a Phase 1, dose-escalation clinical trial to examine the safety, tolerability and preliminary efficacy of the combination therapy with atezolizumab (in collaboration with Roche) in patients with advanced solid tumors. The preliminary data are expected in the fourth quarter of 2020.
– Clinical development in China: TJD5 is on track in a Phase 1 clinical trial to evaluate the safety, tolerability, PK/PD, and potential efficacy primarily in patients with solid tumors, including lung cancer, as a single agent and the combination therapy with a PD-1 (in collaboration with Junshi).
TJM2 or plonmarlimab (anti-GM-CSF):
– In May 2020, I-Mab announced results from Part 1 of a multi-center, double blinded, randomized, placebo-controlled, three-arm clinical study of TJM2 in patients with cytokine release syndrome (CRS) associated with severe COVID-19. TJM2 is found to be well tolerated in patients with severe COVID-19.
– I-Mab is currently conducting Part 2 of the clinical trial to evaluate the efficacy, safety and cytokine levels following a single dose of 6 mg/kg TJM2 or placebo (standard care) in patients with severe COVID-19. The Company is currently in discussion with the FDA to finalize the plan for TJM2 in relation to clinical development and potential registration in the U.S.
– I-Mab has recently initiated a multiple-dose Phase 1b study with TJM2 in patients with rheumatoid arthritis (RA) in China.
Early-stage pipeline of novel monoclonal antibodies advancing toward clinical development in the U.S. and China:
– TJ210 is a novel monoclonal antibody directed at C5aR for cancers through a partnership with MorphoSys. I-Mab submitted IND to the U.S. FDA in August and plan to subsequently initiate clinical development in the U.S. upon IND approval. I-Mab also plans to initiate development of TJ210 in China.
– In June 2020, I-Mab and ABL Bio presented preclinical data on a newly developed, novel bispecific antibody, TJ-CD4B, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting. TJ-CD4B has a duel targeting property combining Claudin 18.2 (a gastric- and pancreatic-specific cancer antigen) and 4-1BB and is uniquely structured to supercharge T cells in a Claudin 18.2-dependent manner, enhancing anti-tumor immunity while potentially minimizing toxicity.
"Fast to Market" China Portfolio
TJ202 or felzartamab (differentiated anti-CD38) for multiple myeloma (MM):
– I-Mab is conducting two parallel registrational trials with TJ202 as a third-line monotherapy and as a second line combination therapy with lenalidomide, both in patients with multiple myeloma in Taiwan and mainland China. The trials are ongoing, and recruitment progress remains on track. The Company expects to complete a BLA submission in 2021.
TJ101 or eftansomatropin (differentiated long-acting growth hormone) for pediatric growth hormone deficiency (PGHD):
– The China National Medical Products Administration (NMPA) has accepted an IND application for a registrational phase 3 study to assess the efficacy, safety and pharmacokinetics of TJ101 in PGHD. The Company expects to obtain IND approval in the fourth quarter of 2020 and initiate the phase 3 study subsequently.
TJ107 or efineptakin alfa (long-acting interleukin 7) for glioblastoma multiforme (GBM):
– Following a phase 1b clinical trial, I-Mab has obtained regulatory clearance from the China NMPA to initiate a phase 2 clinical trial with TJ107 in glioblastoma multiforme patients with lymphopenia in the fourth quarter of 2020.
TJ301 or olamkicept (differentiated interleukin-6 inhibitor) for ulcerative colitis (UC) and other autoimmune diseases:
– The phase 2 clinical trial is on-going to enroll remaining patients to assess the pharmacokinetics, safety, and efficacy of TJ301 in patients with active ulcerative colitis. The enrollment is expected to complete in the third quarter of 2020. Topline data is expected to be released by early 2021.
In July 2020, I-Mab’s Board of Directors authorized a stock repurchase program under which the Company may repurchase up to US$20 million of its ordinary shares in the form of American depositary shares.
In July 2020, I-Mab announced its 2020 Share Incentive Plan (the "Plan"), the maximum aggregate number of shares which may be issued pursuant to all awards shall be 10,760,513 Ordinary Shares. The purpose of the Plan is to provide management and staff with ownership-based incentives for achievements of critical corporate and clinical development milestones to generate superior returns to the Company’s shareholders.
In May 2020, I-Mab expanded its global footprint with the opening of the Company’s Hong Kong office, serving as a regional hub for the Company’s capital markets and investor relations activities.
In July 2020, I-Mab appointed Mr. Ivan Yifei Zhu as the Company’s Chief Commercial Officer. Mr. Zhu has more than 20 years of successful commercialization experience and held senior executive positions at global, domestic pharma and biotech companies. In his new role, Mr. Zhu will focus on building and developing I-Mab’s commercialization infrastructure and strategies and preparing the Company for upcoming product launches.
First Half 2020 Financial Results
As of June 30, 2020, the Company had cash, cash equivalents, restricted cash and short-term investments of RMB1.6 billion (US$221.1 million), compared with RMB1.2 billion as of December 31, 2019.
Total net revenues for the six months ended June 30, 2020 were nil, compared with RMB15.0 million for the six months ended June 30, 2019.
Research & Development Expenses
Research and development expenses for the six months ended June 30, 2020 were RMB442.3 million (US$62.6 million), compared with RMB265.1 million for the six months ended June 30, 2019. The increase was primarily due to increases in CRO service fees to advance the Company’s pipelines, higher share-based compensation, and higher employee salary and benefits expenses due to increased research and development headcount.
Administrative expenses for the six months ended June 30, 2020 were RMB171.4 million (US$24.3 million), compared with RMB574.6 million for the six months ended June 30, 2019. The decrease was primarily due to reduced share-based compensation expenses of RMB268.9 million (US$38.1 million).
Net loss for the six months ended June 30, 2020 was RMB582.9 million (US$82.5 million), compared with RMB857.3 million for the six months ended June 30, 2019. Net loss per share attributable to ordinary shareholders for the six months ended June 30, 2020 was RMB4.78 (US$0.68), compared with RMB119.34 for the six months ended June 30, 2019.
Non-GAAP Net Loss
Non-GAAP adjusted net loss, which excludes share-based compensation expenses, for the six months ended June 30, 2020 was RMB353.1 million (US$50.0 million), compared with RMB491.0 million for the six months ended June 30, 2019. Non-GAAP adjusted net loss per share attributable to ordinary shareholders for the six months ended June 30, 2020 was RMB2.90 (US$0.41), compared with RMB68.34 for the six months ended June 30, 2019.
Conference Call and Webcast Information
The Company will host a live conference call and webcast on August 31, 2020 at 8:00 a.m. ET. Participants must register in advance of the conference call. Details are as follows:
Upon registering, each participant will receive a dial-in number, Direct Event passcode, and a unique access PIN, which can be used to join the conference call.
A webcast replay will be archived on the Company’s website for one year after the conclusion of the call at View Source
A telephone replay will be available approximately two hours after the conclusion of the call. To access the replay, please call +1-855-452-5696 (U.S.), +61-2-8199-0299 (International), 400-632-2162 (Mainland China), or 800-963-117 (Hong Kong). The conference ID number for the replay is 8959387.