NovaBridge Biosciences (NBP) Earnings Call Transcript & Summary

Good morning or good evening. Thank you for standing by. This is Tianyi Zhang, IR Head of I-Mab Pharma. Thank you for joining the conference call today. Yesterday, I-Mab announced strengthening of the management team to accelerate global pipeline development and the transformation towards commercialization. Dr. Andrew Zhu, a internationally renowned oncologist was appointed as President and Board of Director to lead the company's R&D organization, focusing on global pipeline developments. Today's call, we will have the management team to give you more insights of the new appointment and the company's development strategy. Joining me today from I-Mab's senior management team include Dr. Jingwu Zhang, Founder and Chairman of I-Mab; Dr. Andrew Zhu, President of I-Mab; and Mr. John Long, CFO of I-Mab. Now I'd like to turn the call to Dr. Jingwu Zhang, Founder and Chairman of I-Mab. Dr. Zhang, please?

Thank you, Tianyi. Good evening or good morning depending on where you are. Thank you all for joining us today for the call. On this call, I would like to elaborate Andrew's appointment as indicated in our announcement released yesterday. Firstly, I'm very excited to introduce Dr. Andrew Zhu. Andrew is an internationally renowned oncologist. He was a professor at the Harvard Medical School and led a world-class liver cancer center in U.S. top clinical institutions, Mass General Hospital and Dana Farber Cancer Institute. Andrew published over 300 scientific papers and reviews in prestigious journals such as New England Journal of Medicine, JAMA, Nature and so on. Andrew has a great passion for clinical research and drug development. He led or participated in over 50 global oncology clinical trials working with global big pharma groups such as Merck, Roche, Novartis and Eli Lilly. As an international oncology expert, Andrew's recent China clinical experience is also worth noting. Prior to joining I-Mab, he was a Director and Chief Scientific Officer of Jiahui International Hospital in Shanghai, leading the clinical oncology center there. I must say Andrew joins I-Mab at a critical time when our innovative pipeline has already progressed to the stage of proof of concept and some are in or about to enter registrational trials. As a global frontrunner biotech, we are currently facing 2 major challenges in our pipeline development. Firstly, there are significant challenges of getting these key assets through proof-of-concept clinical trials or registrational trials because many of our clinical assets are among the global frontrunners, so there are no prior data or clinical experience to follow with this highly innovative drug molecules. In this regard, Andrew's world-leading clinical oncology expertise and the experience in drug development will play a critical role to safeguard our pipeline development for a high profitability of success. In short, the success of global innovative pipeline must be led by a world-class oncology expert and a leader in the field. Secondly, in 2021, we have achieved almost all critical clinical and corporate milestones. We will detail the progress and achievements in the annual report later. 2022 is an even more exciting year for the company because we are prepared to deliver a series of high-impact milestones and value creation catalysts. On the clinical development front, we expect to have 20 clinical trials in both U.S. and China in 2022. Among them 15 will be Phase II and Phase III clinical trials, including 4 registrational trials for Felzartamab, eftansomatropin and lemzoparlimab. Our bispecific assets and some of the third wave novel compounds will enter critical preclinical development stage preparing for R&D and later clinical trials. To effectively deliver these critical milestones is another challenge. So that is why we are so excited about Andrew's joining to effectively address the challenges that we are facing today as we rapidly advance our global innovative pipeline. We believe under Andrew's new R&D leadership, we are confident to deliver this clinical milestones to further realize the value of our top line. Andrew is now President of the company with a role as a Chief Medical Officer to lead our global research and development in both U.S. and China. I'm very confident that Andrew's oncology expertise, his research, leadership and passion for drug development will greatly help our pipeline development and strengthen our overall R&D capabilities. Last but not least, I'd also like to take the opportunity to thank Dr. Joan Shen for her important contribution and leadership in our early-stage pipeline development, which has laid a solid foundation for the progress we have made so far. Now I would like to ask Andrew to introduce himself and speak to his view on I-Mab's pipeline. Andrew?

Thank you, Dr. Zang, for the kind introduction. Hello everyone. This is Dr. Andrew Zhu. Thank you for joining us with your valuable time today. I'm really honored to join I-Mab at this very [indiscernible] flagship point as the company is under transformation from a clinical stage biotech to a global biopharma. As a matter of fact back to June this year, I had the pleasure joining I-Mab Scientific Advisory Board. So I became really impressed with the company pipeline as well as the company's visionary management team and globally competitive pipeline and unique development strategy. Indeed, I think I-Mab has definitely accomplished impressive achievement within the past 5 years. Please allow me to introduce myself to take this opportunity to introduce myself. I actually graduated from Peking University Health Science Center. Upon graduation, I pursued a PhD in molecular [ virology ], microbiology from Columbia University. And following a post-op training at Harvard Medical School, I completed the internal medicine training at Yale New Heaven Hospital, Yale School of Medicine and also a Hematology-Oncology fellowship at Memorial Sloan-Kettering Cancer Center. In 2000, I had the pleasure of joining the staff at Mass General Hospital and Harvard Medical School. And subsequently, I became the Director of the liver cancer research and also I was promoted to Professor of Medicine at Harvard Medical School in 2016. I'd like to take this opportunity just to reflect a few things that I personally feel very proud during my tenure at MGH Harvard. First, I had the pleasure to collaborate with my colleagues, really some of the very talented colleagues at Mass General from many, many specialties, including surgical oncology, radiation oncology, radiology, hepatology, pathology and really create a multidiscipline liver cancer center and we also established a multi-disciplined MTD team for the care of patients suffering from hepatobiliary cancer. And this has actually served as a platform for training the next-generation residence fellows, but also has served us as a very critical platform to engage and also to expand our clinical research program and second, while at MGH, I actually established a very vigorous clinical as well as transitional research program in hepatobiliary cancer and also had the pleasure leading and participating in more than 50 global clinical trials and some of them have actually led to the regulatory approval by FDA including pembrolizumab for KEYNOTE-224 trial, ramucirumab REACH-2 trial and also Ivosidenib for ClarIDHy in cholangiocarcinoma. Of note, the REACH-2 trial truly represents the first biomarker-driven clinical trial in hepatocellular carcinoma and also the ClarIDHy trial with Ivosidenib represents the first Phase III target therapy study conducted in cholangiocarcinoma. On the translational front I also had the pleasure of identifying the IDH mutations in cholangiocarcinoma as well as uncovering the drug resistance mechanism to [ FGFR ] resistance in collaboration with many talented colleagues at MGH. I think in recognition of my achievement and leadership, I have been invited to serve many national societies and committees including the hepatobiliary cancer committee of the NCCN and also the ASCO brand selection committee, the hepatobiliary cancer taskforce of NCI for gastrointestinal cancer center and hepatobiliary taskforce. I'm also -- I have also served many guideline committees as well as the committee for clinical trial standardization in cholangio as well as hepatocellular carcinoma and these include with NCCN guideline for hepatobiliary cancer, the AASLD guideline for the treatment of hepatocellular carcinoma and the ASCO guideline for systemic therapy for advanced hepatocellular carcinoma. I think we all know there definitely remains significant unmet medical needs in the treatment of cancer on the global stage. Unfortunately, China has contributed almost 50% of the global cancer burden. So I think I definitely have the urge of bringing some of the expertise as well as research skills back to China to serve the Chinese patients suffering from cancer and also training the medical oncologists here. So in 2019, I had the opportunity joining the Jiahui International Hospital as the Director of Jiahui International Cancer Center and subsequently as the Chief Scientific Officer of Jiahui Health. And during the past 2 years, I think it's really gratifying that we actually really create a small new cancer center of international standards and we continue to deliver true multi-disciplined care to patients in Shanghai and also other parts of China for patients suffering from different types of cancer. I think while in China, I also had the pleasure interacting with a lot of the key opinion leaders in oncology in China and also had the pleasure interacting with a lot of the colleagues working in the pharmaceutical industry. I think it's really through this interaction I think, I had the pressure of interacting with I-Mab and also I became the SAB member through I-Mab. I'm really, really excited to be involved in the innovative, highly differentiated pipeline that will potentially really bring the hope to patients suffering from different cancer. So I really look forward to working with I-Mab R&D team to efficiently accelerate the global development process in the future. I think during the past few years, I think we have definitely witnessed the revolution through the targeted therapy as well as lately the immunotherapy development. As a concrete investigator and also a leader in the field, I had the fortune of directly getting involved in development of several targeted and IO therapies. I think I-Mab's innovative, highly differentiated and mature pipeline definitely has the potential to bring new therapies for patients in need worldwide. I think currently, I-Mab's core asset including the CD47 and CD73 antibodies are definitely the global frontrunners and first-in-class in China. And these assets are already in the proof-of-concept studies and will potentially lead to registration of clinical trials in the near future. So at this critical time point, the leadership at I-Mab has definitely realized the importance of accelerating the innovative assets to very rapid clinical development, so that we can really make these drugs to be successfully developed, so more patients can actually benefit from this treatment. So I think I personally believe that my extensive experience and expertise in oncology and clinical trial design will definitely help I-Mab's R&D program and -- both in China as well as globally. So I really look forward to working with I-Mab's colleagues and also the cross-functional teams to deliver the clinical and PD milestones bring new and innovative therapies to our patients around the world. And also truly [indiscernible] the company's vision and goal of advancing into a true global biopharma. I also really look forward to meeting some of you in person in the future, so that we can actually have face-to-face discussion. Thank you for your attention.

Thank you, Dr. Zang and Dr. Zhu. Now we will start the QA session. [Operator Instructions] The first question comes from Kelly Shi. Kelly, please. Kelly, I think you need to unmute, put -- press the unmute button.

Can you hear me now?

Yes, please.

Okay. This question is for Andrew. Nice to meet you online. Why do you choose to join I-Mab at this time? And what is your view about I-Mab's platform in terms of novelty, breadth and depth? And accordingly could you share with us with your [indiscernible] for the clinical team and the clinical development strategy in both U.S. and China?

Well, thank you Kelly, for this very very interesting question. I think the reason to join I-Mab obviously is through several key reasons. I think I have to say, I mean I'm incredibly impressed by Dr. Zang's vision, courage and also the proven experience and track record. And also I-Mab really has assembled a very young, but [ dynamite ] team with passion. I think the science in I-Mab is really the key to drive the current development. And also, we do actually have a very innovative pipeline. With regard to the I-Mab pipeline, I had the pleasure serving on the I-Mab's scientific advisory board. So I'm very, very impressed about this pipeline. I think this probably can be summarized through the following: I think the first one is really the nature of innovation. I think I-Mab really strive only to develop the first or best-in-class and second is really the depth of the pipeline. I think as you can see, we truly have a very, very well organized and reached development layers. We have the first generation with very highly differentiated antibody with unique targets. We also have the second generation with bispecific antibody and also we have actually really aiming to have the third generation, the so-called super antibody through various technologies. And also if you look at the stage of our development, we are also at a very advanced stage. I think we -- if you look at the 10 clinical stage asset with 20 clinical trials planned in 2020, we actually have up to 15 trials at the late stage and also including full registration trials. So this is really also highlights the maturity of the growth of I-Mab. So in my opinion, I think I-Mab's pipeline certainly represents perhaps one of the best innovation for the time of our tech companies. And certainly, it's among one of the best, even oncology pipelines in the world. So I think we all have our personal opportunities in our career development. And also some of them came really by luck. So I think Dr. Zang and I really bump into each other about 2 months ago. We actually really exchange our ideas about the company as well as its potential. I think we really very well, very quickly with good personal chemistry and also it turned out that we truly share really very similar vision and very, very same passion. And also, we both actually highly value signs both in terms of drug development and also in clinical trial design. We also both share the vision that if we can actually accelerate the clinical development. We can certainly unleash the potential of I-Mab even to the next level. So I think it's fair to say that I think it will be incredibly exciting and [indiscernible] to bring some of the innovative pipelines at I-Mab to the finish line, so that we can actually have more successful registration trials with approved drugs and more importantly, we can really let more patients suffering from different type of cancer to benefit [indiscernible] innovative pipeline. So with that, I truly think this is actually a right time to join I-Mab so that I can have the pleasure working with many colleagues within I-Mab to achieve these goals. We are obviously thinking about various innovative strategies. I think I will be very happy to exchange these down the road through another call. I think some of the strategies, you can probably imagine. We are thinking about the best combination strategy, particularly in the IO space. I think the biomarker-driven study is something that we should definitely consider very critically. We definitely need to identify the right patient population in this very competitive clinical trial development environment. I -- obviously, I think with my expertise, we need to really consider some of the innovative trial design, so that we can really improve the chance for trial success. Obviously, how to improve the operation so that we can actually efficiently moving the trial at full speed both in China and also globally definitely is on our agenda as well. So I think with that, I want to thank you for giving me the opportunity to answering your question.

Thank you, Dr. Zhu. Our next question comes from Huang Yang at CS.

This is Yang from Crédit Suisse. So I have 2 questions. First question for Dr. Zang and then another question for Dr. Zhu. So Dr. Zang recently, there seems to be some concern about new drug filing BLA or NDA in the U.S. with China only a late-stage clinical data. So can you share your view what you're thinking about the potential ratio to China biotech, especially how do you think that will impact I-Mab's clinical program? That's my first question. And I will ask the second question.

All right. Thank you for the question. Well, the answer is that there's no impact on I-Mab because our R&D model is different and it's global. First of all, we only work on innovative immuno-oncology assets of the first-in-class and best-in-class potential. For this global innovative assets our R&D model is to run through our U.S.-based clinical development team. They work together with the China team to find R&D in the U.S. and first start clinical trials in the U.S. to generate necessary clinical data related to drug safety, early efficacy signals and most importantly,the intended clinical differentiation of innovative drug molecules and this is an important step for clinical validation. We then rely on clinical data generated in the U.S. to partner with global big pharma groups to advance these assets to late-stage clinical development and eventually to global product registration. So our clinical data are generated globally for global registration and that's the difference. Secondly, in parallel, we retain all China rights of the assets to develop them in China, which can leverage the clinical data generated in the U.S. to facilitate the China developments of the assets all the way to product registration in China. So this unique R&D model was invented by I-Mab and has worked effectively in I-Mab. The best example is lemzoparlimab our highly differentiated CD47 antibody. We first started clinical trials in the U.S. and then partnered assets with AbbVie using a clinical data generator in the U.S. Now as a result, AbbVie is now leading the global clinical development for global product registration. I-Mab is leading the China development and we share top line clinical data to best advance the development in a global setting. So our clinical development and clinical data are global and are not China-only. Now this unique R&D model has also generated some additional benefits that is to help the company to create cash flow during different stages of clinical development of our innovative assets. For example, through multiple global and domestic licensing of partnership deals that have already completed so far, our cash flow is expected to mount to close to USD 1 billion in cash by 2025. And we are continuing to do more such partnership deals including uliledlimab, our differentiated CD73 antibody to strengthen our cash position. Now this is really I can summarize to really address this question. Andrew, do you have anything to add?

So I think I had the pleasure working with many major pharma on global Phase III trial, registration trials. I think in general, when you design the Phase III trial, you definitely need to have very good representation for patients in each particular region. So I think this is actually in line with the strategy I-Mab is taking. So you start with the adequate trial design with good representation of the patient population from each particular region. So personally I think with the I-Mab strategy, I think this will not be affected by the concern you raised.

Thank you, Dr. Zang and Dr. Zhu. Due to time limitation, I think we will take 1 last question. Our last question comes from Jennifer Kim. Jennifer, please.

This is Jennifer Kim on for Louise Chen from Cantor. I have 2 questions. First, I'm wondering, could you give us an update on the current status for your BLA submission for Felzartamab in third-line multiple myeloma? And my second question is could you update us on the dual-listing process?

Well, thank you, Jennifer. Maybe I can take the first question and leave the second one to our CFO, John, to elaborate. So for your question -- first question as we already mentioned earlier, our registrational trial for Felzartamab is successful. And in that study all primary and secondary endpoints are met. As a result, our BLA submission package is ready for submission. Now we are in the process of delivering the submission package to CDE in China and we hope to complete this process before the end of this year. Now for your second question, I will ask John to elaborate.

Thank you for your question. With respect to the company's Hong Kong dual listing we have announced the company's plan and shared our rationale in the investor call last week. I think our message is loud and clear. In order to complete Hong Kong dual listing by 2022, we have taken on necessary actions to accelerate the procedures. I want to just share 2 key updates today. First, the company already confirmed to prepare for primarily listing as the root of the application. Our main consideration here is to accelerate the application process under the primary listing rules as we don't want to wait 2 full fiscal years as required by secondary listing. For I-Mab, the primary listing is the most efficient way. It would provide alternative trading platform for our ADS investors in addition to NASDAQ and will help mitigate the potential ADS uncertainties, which might be caused by U.S.-China geopolitical risk. The second update is that we have already set a specific timetable for Hong Kong [indiscernible] and formed the listing project team. Our goal is to complete the official dual listing by end of 2022. The project team and our sponsors are currently working on the preparation work as we speak and will submit A1 application as soon as possible based on Hong Kong Exchanges and other regulatory requirements. And we are confident the team we can meet the set time table with all the groundwork the team has finished so far. Thanks again for the question.

Thank you, Dr. Zang and John. And thank you everyone for joining our call today. So if you have any further questions, please feel free to reach out to our IR team. And I wish you all have a good day.

Thank you.

Thank you.

Thank you.