SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the month of November 2020
Commission File Number: 001-39173
Suite 802, West Tower, OmniVision, 88 Shangke Road, Pudong District
Peoples Republic of China
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|Title||:||Director and Chief Financial Officer|
Date: November 13, 2020
Exhibit 99.1Press Release
I-Mab to Hold Investor Call and Expand Clinical Data Analysis on Efficacy Signal of Lemzoparlimab from Phase 1 Clinical Trial
SHANGHAI, China, and GAITHERSBURG, MD. November 12, 2020 I-Mab (the Company) (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that it will hold a call with investors on Friday, November 13 at 8:20 a.m. ET to provide deep dive analysis of preliminary clinical efficacy results of its U.S. phase 1 clinical trial (NCT03934814) evaluating lemzoparlimab (also known as TJC4) for the treatment of relapsed or refractory solid tumors. The results are being presented this week at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting. The purpose of the call is to provide an expanded analysis of the clinical efficacy signal from the U.S. phase 1 clinical trial, which is not previously discussed.
Please click here to access the meeting presentation.
I-Mab Conference Call and Webcast Information
Investors and analysts are invited to join the conference call on November 13 at 8:20 a.m. ET using the following dial-in information:
A live webcast and an archived replay of the conference call can be accessed on the Companys investor relations website at http://ir.i-mabbiopharma.com.
A telephone replay will be available approximately two hours after the conclusion of the call by dialing +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 4556519. The replay will be available through November 20, 2020.
About CD47 and Lemzoparlimab
CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a dont eat me signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells, making it a potentially promising cancer drug. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. In a scientific breakthrough, scientists at I-Mab have discovered a unique CD47 antibody, lemzoparlimab, that works efficiently to target tumor cells while exerting minimal untoward effect on red blood cells, thus avoiding severe anemia.
Lemzoparlimabs hematologic safety advantage and superb anti-tumor activities have been demonstrated previously in a series of robust pre-clinical studies. The results of the phase 1 clinical trial have provided further, clinical validation of this differentiation in patients with cancer. I-Mab continues to advance a combination study of lemzoparlimab with Keytruda® for the treatment of solid tumors and with Rituxan® for the treatment of patients with lymphoma in the U.S., in addition to an ongoing clinical trial with patients with AML/MDS in China.
In September 2020, I-Mab and AbbVie entered into a global strategic partnership to develop and commercialize lemzoparlimab, including to design and conduct further clinical trials to evaluate lemzoparlimab in multiple cancers globally and in China. The collaboration is subject to certain pre-closing conditions.
I-Mab (Nasdaq: IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Companys mission is to bring transformational medicines to patients around the world through innovation. I-Mabs innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Companys Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter and WeChat.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the lemzoparlimab (TJC4) phase 1 trial, the potential implications of clinical data for patients, and I-Mabs advancement of, and anticipated clinical development, regulatory milestones and commercialization of lemzoparlimab (TJC4). Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mabs ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mabs drug candidates; I-Mabs ability to achieve commercial success for its drug candidates, if approved; I-Mabs ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mabs reliance on third parties to conduct drug development, manufacturing and other services; I-Mabs limited operating history and I-Mabs ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Companys clinical development, commercial and other operations, as well as those risks more fully discussed in the Risk Factors section in I-Mabs most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mabs subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and 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.
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