NovaBridge Biosciences (NBP) Earnings Call Transcript & Summary

Hello, everyone. Thank you for coming and to join the call for I-Mab. I'm Bank of America analyst, Yang Huang, covering China health care. And today, we're inviting Dr. Zang Jingwu to give our -- a presentation to introduce the most recent update for I-Mab. As you know, I-Mab recently IPO-ed and has quite a few updates on its clinical pipeline. And yes, so Dr. Zang, you can start.

Pleased to introduce I-Mab biopharma. I-Mab biopharma is unique among China-based biotech companies as we only focus on discovery, development and the future commercialization of biologics, innovative biologics with first-in-class, best-in-class potential. This focus is mostly attributable to our R&D strengths in immunology, and we stand out as a leading immunology company in China. If you turn to Page 2, we have been taking 2 strategies to build our pipeline. One strategy, I'll call it, global strategy, where we rely on internal R&D capabilities based in -- we work with CROs like WuXi Biologics to hospitals and CROs to bring out innovative molecules into Phase I, Phase II clinical trials. And at the same time, we initiate clinical studies in China to bring those molecules all the way to registration. And this is our global strategy. Now under our global strategy, now we have a portfolio of a drug, clinical- and preclinical-stage molecules that we're actively developing, both in U.S. and China. And I'm going to come back to talk about some of the key assets that are in development in both U.S. and China. Now the other strategy, I call it the China strategy, where we go around the world in U.S. and Europe. We worked with our global partners, and we in-licensed clinical -- innovative clinical-stage assets that have already completed Phase I, Phase II clinical trials with excellent safety data and some of the efficacy data. And our strategy is to work with our partners, leverage the clinical data generated in the U.S. and Europe. And bring -- rely on our strength in China -- development strengths in China and bring those molecules all the way into Phase II, Phase III clinical trials. And our goal is to shorten the development time and to bring those molecules to registration and the launch of the products in China because our primary market is in China. Now on the -- this China strategy, we have 5 in-licensed clinical-stage programs, and 2 of them are already very advanced. They are in Phase III registrational trials. And the first molecule, we expect to file BLA mid next year and to launch the product in 2022. And it's going to be the first product to launch in China from our pipeline, and then that would be followed by a series of BLAs and product launch. Now if you turn to Page 3, this is our pipeline chart. As I mentioned earlier, if you look at the lower part of this chart, this is our global portfolio. There are 5 monoclonal antibodies and 7 bi-specific antibodies that are mostly focused in the immuno-oncology space. Let me mention this 3 monoclonal antibodies that are already in the clinical development in both U.S. and China. The first one is GM-CSF neutralizing antibody that is developed for autoimmune diseases. At the same time, we are developing this particular asset for cytokine release syndrome associated with COVID-19. We recently filed IND in the U.S. and got IND approval from the U.S. FDA. Now we are in a position to start a clinical trial in the U.S. for cytokine release syndrome associated with COVID-19 patients. The second asset is our highly differentiated CD47 monoclonal antibody, and this particular asset is globally competitive because it's differentiated for its safety advantage as compared to other clinical-stage CD47 antibodies because our antibody is screened to avoid binding to red blood cells. So our antibody has minimum binding to red blood cells. In a preclinical study, our antibody does not induce severe anemia in the cyno monkeys in a GLP tox study. Now we are running 2 clinical trials, both in U.S. and China. In U.S., our current clinical trial is a focus on dose escalation to really validate our safety advantage of TJC4 in patients with solid tumors and lymphoma. There are 5 dose levels from 1 milligram all the way to 30 milligram. We have already completed the first 3 dose levels, 1 milligram, 3 milligram and 10 milligram per kilo. And so far, we have not seen severe side effects or severe anemia. We still have 2 levels to go, and we expect to complete the whole dose escalation study in the third quarter of this year. Now in China, our clinical trial is focused on patients with AML/MDS. We just dosed the first patient in the past few days, and this trial has officially kicked off. And we expect to advance this trial very quickly in China. And the next -- the third monoclonal antibody is TJD5. This is another very competitive -- globally competitive CD73 monoclonal antibody in the immuno-oncology space. We are currently running a clinical trial in the U.S. to explore its role in the treatment of cancer patients. And we are currently at the safety part of the study, expect to complete the safety part of the study in the third quarter of this year and then continue with the effective dose to further evaluate safety and efficacy in patients with solid tumor. Now in China, we already obtained IND approval, and we're about to start clinical trial in patients with solid tumors, including lung cancer. Okay. So those are the 3 most advanced monoclonal antibodies on our global portfolio. And in the third quarter this year, we're going to start 2 new monoclonal antibodies. One is TJ210 to target a C5a receptor. And this is a monoclonal antibody we are in partnership with MorphoSys. We expect to file IND in August this year with the U.S. FDA and then start a clinical trial in the U.S. And this is for cancer indication. And the other new monoclonal antibody is TJX7. CXCL13 is the target designed for autoimmune diseases, and this particular antibody has first-in-class potential. We expect to file IND August this year and begin the clinical trial in the U.S. afterwards. And these 5 monoclonal antibodies are followed by a panel of 7 bi-specific antibodies that are all designed for immuno-oncology for the cancer space. And today, I don't have the time to talk about those bi-specific antibodies, but we are very, very excited by the potential of bi-specific antibodies in the cancer space. Now if you look at the top part of this pipeline chart, where there are 5 in-licensed advanced clinical programs, the first one is CD38 monoclonal antibody with license from MorphoSys. Now currently, we are running 2 registrational trials in China for multiple myeloma. The first one is a third-line treatment for multiple myeloma, a registrational trial, 82 patients in the trial, and we expect to file a BLA for this particular asset and expect to launch the product in China in 2022. And the other registrational trial is a combination therapy with lenalidomide, involving about 291 patients from -- as a second-line treatment for multiple myeloma. And that trial is going to take a little bit longer time to complete and then to get to the market. The second asset from our China portfolio is a long-acting growth hormone. And there's a huge growth hormone market in China, and our asset is highly differentiated among all the products marketed in China. Now for this asset, Genexine -- we licensed from Genexine. Genexine completed a Phase II clinical trial in Europe with excellent safety data and efficacy data. Now we are ready to file IND in China in June this year to start a Phase III clinical trial. And depending upon the approval time, we can -- we perhaps can start our Phase III clinical trial as early as end of this year or early next year. This is a 240-patient trial to compare with daily injectable recombinant growth hormone for safety and efficacy. And then the third is a -- is TJ301. It's a differentiated IL-6 blocker we licensed from Ferring. Currently, we're running a Phase II clinical trial in China in patients with ulcerative colitis. We expect to complete this clinical -- Phase II clinical trial in China by the end of this year and to report Phase II top line data. And then the fourth asset on the list is B7-H3 monoclonal antibody we licensed from MacroGenics. We are currently working closely with MacroGenics to lock the CMC process, to file IND in China to start a pivotal study in China in cancer patients with head and neck cancer. And the last one is a long-acting IL-7, which we licensed from Genexine. As we speak, we are running a Phase Ib clinical trial in China, and in the second half of this year, we expect to start a Phase II clinical trial in patients with GBM. And this particular asset, it's very exciting because it's designed to treat patients with lymphopenia of the chemotherapy and radiation therapy. Okay. So if you turn to Page #8, and I just want to highlight, although we are managing a pipeline of 17 clinical and preclinical assets and our focus is really on these core 3 assets, the first 2 are globally competitive. They are a differentiated CD47 monoclonal antibody and CD73 monoclonal antibody, and we're running clinical trials, both in U.S. and China and to really demonstrate the novelty and safety of our compounds and how our compounds are differentiated from our competitor compounds in this very, very competitive space of immuno-oncology. And the other assets, the other 2 assets, CD38 monoclonal antibody, long-acting growth hormone, we are actively developing these 2 programs in China because these are the 2 most advanced assets from our pipeline to launch in China. For CD38, the first product launch is in 2022, and for growth hormone, it is in 2024. And with the product launch of these 2 programs, this is going to signal the transformation of this company from a clinical-stage company now to a commercial stage company within the next 3 to 5 years. So I'm very excited by the fact we successfully listed in -- on NASDAQ early this year. The company has already transformed from the early-stage discovery company 4 years ago now to a clinical-stage company with 8 active clinical programs running, both in U.S. and China. And as I mentioned earlier, our vision is to move towards a fully integrated global pharma in the next 3 to 5 years with a manufacturing capability and commercial capability. I think I'm going to end here. Just want to say thank you very much for this opportunity, and I look forward to our future interactions.

Yes. Okay. Thanks a lot for Dr. Zang's presentation, who is the Founder and Honorary Chairman of I-Mab. I think he gave a nice presentation of the company's China and the global portfolio. And if you have any questions, you can either contact me or contact the company IR. I think we will have a few one-on-one meetings at our conference. And again, thank you for your participation for today's I-Mab presentation. Thank you all. Bye now.