8/31/2020

speaker
Rachel
Operator

Ladies and gentlemen, thank you for standing by, and welcome to the IMAP 2020 Interim Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. It is now my pleasure to turn the call over to Jilin Zhu, IMAP's Chief Financial Officer and Director. Please go ahead, Mr. Zhu.

speaker
Jilin Zhu
Chief Financial Officer and Director

Thank you, Rachel. Welcome to the IMF 2020 interim financial results and the business update conference call. Earlier this evening, we issued a press release providing a review of our financial results for the six months ended June the 30th, 2020, as well as an overview of our recent corporate highlights and upcoming milestones. The press release can be accessed on the investor's portion of our corporate website, ir.imapbiofarmer.com. Joining me today on the call from IMAP's senior management team are Dr. Jingwu Zhen, our founder, honorary chairman, and director, Dr. Zhong Shen, our chief executive officer and director, and Mr. Yifei Zhu, our chief commercial officer. Mr. Zhu recently joined IMAP and will be driving our commercialization efforts in preparation of our first product launch in China. Dr. Zhang will provide a high-level overview of our recent achievements and upcoming milestones, and Dr. Shen will comment on the status of our key development programs in greater detail. I will then provide a brief summary of our financial results for the six months ended June 30, 2020, before we turn the call back over to the operator so we may take your questions. Please note the discussion today will contain forward-looking statements relating to the company's future performance and are intended to qualify for the safe harbor from liability as established by the U.S. Private Securities Litigation Reform Act. Such statements are not guarantees of future performance and are subject to certain risks and uncertainties, assumptions, and other factors. Some of these risks are beyond the company's control and could cause actual results to differ materially from those mentioned in today's press release and this discussion. A general discussion of the risk factors that could affect IMAP's business and financial results is included in certain filings of the company with the Securities and Exchange Commission. The company does not undertake any obligation to update this forward-looking information, except as required by law. During today's call, we will also discuss certain non-GAAP financial measures for comparison purposes only. For a definition of non-GAAP financial measures and a reconciliation of GAAP to non-GAAP financial measures, please see the financial results news release issued earlier today. Now I will turn the call over to Dr. Jin Wu-Zhang, our founder, honorary chairman, and director. Dr. Zhang, please go ahead.

speaker
Dr. Jingwu Zhen
Founder, Honorary Chairman, and Director

Dr. Jin Wu- Thank you, Jalen. Thank you all for joining us today. I'm very pleased to welcome all of you to our 2020 Intern Financial Results and Business Update Conference Call. This is an exciting time for IMA. We have made substantial progress in pipeline development as well as corporate development over the last several months. And we are on our way to becoming a leading, fully integrated global biopharma company. Firstly, on the pipeline development side, We continue to make remarkable progress across all programs in our pipeline. Lenzopalimab, or TJC4, is an exciting drug molecule discovered and developed internally. It is highly differentiated from some other clinical stage anti-CD47 molecules in development. We have recently completed the Phase I dose escalation clinical trial in the U.S. and the results have largely validated the key differentiations of lansopalimab in safety in a favorable PK profile in cancer patients. Joan will provide more details on the clinical data as well as our clinical development plan for lansopalimab in a few minutes. TGFD5, our differentiated anti-CD73 antibody, continues to advance in a phase one dose escalation clinical trial in patients with advanced solid tumor in the U.S., and parallel clinical trial with TGAZ5 in combination with a PD-1 antibody is on track in China. We look forward to safety and PK-PD results from our U.S. trial that are expected to be available in the fourth quarter of 2020. Like CD47, we believe CD73 represents another promising immunontology target that may make a significant difference in the treatment of cancer. PGM2, our anti-GM-CSF antibody, is currently being evaluated for its role in the treatment of cytokine release syndrome associated with severe COVID-19. This development program exemplifies not only our commitment to innovation to deliver new therapeutic approaches to address unmet medical needs, but also our ability to leverage our strengths in regulatory and clinical development capabilities to quickly react to a global health crisis such as COVID-19. We are now on track to advance an ongoing randomized placebo-controlled pivotal clinical study to evaluate the efficacy, safety, and the cytokine levels in 120 patients with severe COVID-19 in the U.S. Now, in addition, we recently initiated a Phase 1B study with TJM2 in patients with rheumatoid arthritis. TJ202, our CD38 antibody, in our China portfolio is being evaluated in two parallel registration of studies in China for the treatment of multiple myeloma. The trials are on track for patient recruitment in 2020. We expect to file a BLA for TJ202 around mid-2021 or in the third quarter in 2021. We also look forward to progressing The ongoing Phase II clinical trial for TGA301 are differentiated, interlocking six inhibitors toward completion in patients with arthritis or colitis. Further, we expect to obtain R&D approval for a registrational trial for TGA101, our non-acting growth hormone for pediatric growth hormone deficiency. Similarly, we plan to initiate a Phase II clinical trial for TGA107, our long-acting interleukin-7 for glioglastoma patients with lymphopenia. We're very excited about getting these two clinical assets started in Phase II and Phase III clinical trials, respectively. Secondly, on the corporate development side, while rapidly advancing our top-line developments with great execution efficiency, we have begun to build our commercialization capabilities. In this regard, I want to highlight the recent appointment of Ms. Yvonne Yifei Zhu as our Chief Commercial Officer. Ms. Zhu has more than 20 years of successful commercialization experience and held senior executive positions at global domestic pharma and biotech companies. He will focus on building and developing IMAP's commercialization infrastructure strategy and preparing the company for future product launches. Mr. Zhu is a great addition to our management team. As part of IMAP's plan to expand our global footprint, In May, we announced the opening of IMET's Hong Kong office, serving as a regional hub for the company's capital markets and investor relations activities. In addition, we plan on building a R&D center in San Diego starting late 2020 to focus on translational medicine, biomarker analysis, and innovative formulation research. which will support the rapid progression of our innovative pipeline globally. As I mentioned at the outset, iMath is well positioned to become a leading fully integrated global biopharma company focusing on immunology. With more and more clinical milestones achieved, the innovative potential of our pipeline has become more visible and validated. as exemplified by a lens of polymap or TJC4. Looking ahead, we are very excited and confident in our science and our increasing capabilities to deliver value through innovation to patients as well as for our shareholders. Thank you now for your attention. I will now turn the call over to Dr. Junson, our CEO, who will review the status of our key development programs in great detail. Dr. Sun.

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