IMAB - NASDAQ

Thank you, everyone, thank you for standing by. And welcome to I-MAb 2021 Interim Business Update and the Financial Results Conference Call. Earlier today, we issued a press release detailing I-Mab's significant pipeline progress and the corporate highlights during the first half of 2021 and upcoming milestones for the rest of 2021, as well as a review of our financial results for the first six months in 2021. The press release can be accessed on the Investor portion of our website. Joining me today on the call from I-MAb's senior management team are Dr. Jingwu

Thank you, Jielun. Thank you all for joining the call today. We are very excited to report to you the remarkable progress that company has made since the beginning of this year. First of all, let me set a stage to tell you where we focus our efforts and resources at a corporate level to generate the most value for the company and our investors. The three of us today will then walk you through the progress in detail. Now on Slide 3. Our corporate focus is twofold with the overarching goal to move our clinical pipeline towards product portfolio. On one hand, we focus on team execution to rapidly advance the pre-BLA and a innovative late stage core assets such as felzartamab, TJ101, TJ107, lemzoparlimab, uliledlimab towards BLA or registrational trials. In parallel, we have been developing the next generation of even more innovative immuno-oncology assets through what we call our second wave innovation characterized as a novel differentiated bi-specific antibodies and third wave innovation characterized as a super antibody enabled by transformative technologies. Now as a result, our pipeline today is not only innovative and globally competitive but also clinically advanced with the first BLA to be submitted in fourth quarter this year. On the other hand, we are building our future to bring the company to the next level on a clinical stage biotech to a global biopharma. In that regards, we have made great progress in building our manufacturing facility in Hangzhou and a commercialization capability to prepare for product launch in China. Now let me walk you through the pipeline developments and the recent progress. On Slide 5, we provide an overview of I-MAb's pipeline. The progress within the past 12 months especially since the beginning of this year has rapidly advanced the pipeline to the stage where our pipeline today is not only innovative and globally competitive but also clinically advanced. We have now one BLA submission, two registrational trials ongoing, seven Phase 2 and eight Phase 1 clinical trials in both U.S. and China. Now the focus of our pipeline is placed around the six core assets as highlighted within the red box because our - because they have potential to become highly differentiated medicines if successfully approved. On Slide 6. I'm excited to report that we have achieved, so far, 13 pipeline milestones since the beginning of this year, including seven new INDs or trial starts, 4 positive data readout events that are considered critical to further developments of the key assets, which we will give you more details later at this presentation. We are on track for BLA submission for felzartamab in fourth quarter 2021 this year. Now on Slide 7, we have a success - successfully completed registrational trial for third line felzartamab for multiple myeloma. Now the topline results have met the primary and the secondary endpoints. More importantly, the study has confirmed clinical advantages of felzartamab in terms of shorter injection time, which are most conveniently used at a outpatient setting and a lower injection reaction rate. Its safety advantages can offer a better treatment option for elderly patients and patients with severe complications. BLA submission now is on schedule for the fourth quarter this year and the company is in preparation of the product launch in terms of market access, inclusion in the National Drug Reimbursement List sales strategy and so on. Now the registrational trial for second-line treatment for multiple myeloma is on track and the enrollment of nearly 300 patients will be completed by the end of next month in September. In addition, we plan on filing a new IND to explore a first-line treatment option for multiple myeloma by combining Felzartamab with one of our own clinical assets in our pipeline. On Slide 8. Regarding TJ101, our long-acting growth hormone. The registrational trial is on track for patient enrollment. There are 165 patients to be enrolled, which will be completed by early 2022 and we are very excited by the outlook of the growing growth hormone market in China and I believe TJ101 has a significant market potential. As we communicated previously, we have been seeking a commercial partnership with one of the pharmaceutical companies who have a pediatric product portfolio and a well-established commercial channel and a specialized sales force. Now I'm happy to report that the business negotiation has advanced to the clinical stage, we hope to finalize the deal and report back soon. On Slide 9, lemzoparlimab, our highly differentiated CD47 antibody. We have made remarkable progress in clinical developments of lemzoparlimab in both U.S. and China, which we hope will lead to registrational trials next year in 2022. Our ambition is to launch lemzoparlimab as the first CD47 antibody product in China and facilitate the global development of our partner AbbVie for global registration. Here is the summary. Firstly, lemzoparlimab in combination with rituximab for non-Hodgkin's lymphoma. Our U.S. trial is on track, and has generated early clinical results, which we are very excited about. As a result, we recently submitted a abstract to present the clinical data at ASH this year and I hope to share the clinical results sooner if possible. While the U.S. trial is ongoing, we have prepared multiple clinical sites in China to join the clinical trial in September next month to expand and facilitate our study. We hope that the current clinical trial will lead to a registrational study for non-Hodgkin's lymphoma in 2022. Secondly, lemzoparlimab in combination with A

Thank you, Dr.

Yes. Thank you, Dr. Shen. Now let's move on to discuss about our efforts and progress in generating the next generation of innovative assets to expand our pipeline. On Slide 13 while we focus on delivering the clinical milestones of the first wave clinical assets, including the six core assets as we just discussed, the company has made significant progress in generating the second and the third wave innovative assets. The first wave innovative assets are represented a portfolio of highly differentiated monoclonal antibodies or fusion proteins, such as lemzoparlimab, uliledlimab, felzartamab, enoblituzumab and so on with one exception, they are all in Phase 2 or Phase 3 clinical trials and they are very advanced. The second wave innovative assets are represented by bi-specific antibodies with either first in class or best in class potential. The two most advanced bi-specific antibodies TJL14B that's PD-L1 4-1BB and a TJ-CD4B that's Claudin 18.2 4-1BB are in Phase 1 clinical trials in the U.S. Now the third wave innovative assets are characterized by emergent portfolio of the super antibodies that are enabled by transformative technologies, some of the drug candidates are expected to advance to the R&D stage by the end of 2022 or 2023. We believe they represent truly cutting edge drug candidates in the field of oncology globally. On Slide 14, our bi-specific antibody portfolio is designed to convert immunologically cold tumors that are resistant to immunotherapy, hot tumors or better treatment efficacy. More importantly, this bi-specific antibodies are enabled to address the current unmet medical need in oncology, where a majority of cancer patients do not respond to checkpoint inhibitors. Two most advanced assets, as I mentioned earlier enter Phase 1 clinical trials in the U.S. early this year, both use the conditional activation of 4-1BB, which is a important differentiation to avoid systemic toxicity induced by 4-1BB. Other bi-specific antibodies are at preclinical stage moving towards R&D. Now on Slide 15, earlier this year, we announced a discovery initiative to generate the third wave innovation. This new generation of antibodies are not regular monoclonal antibodies or bi-specific antibodies. Internally we call them super antibodies because they are enabled by transformative technologies to perform unique drug properties that are otherwise not possessed by regular antibodies. For example, we are working on drug candidates using our partner's messenger RNA platform to deliver formulated messenger RNA drugs that can produce therapeutic antibodies inside the patient body. This is truly transformative if it's proven in clinical trials. Another example is to utilize complex platform to generate intracellular antibodies that can get into cells to target otherwise intractable intracellular drug targets. There are more examples here. We will continue to update you as we make progress with this novel super antibodies. Now on Slide 16. We look forward to delivering a set of 15 critical milestones before the end of this year. In the interest of time, I'm not going to go through the entire list, but to mention a few critical milestones, such as to start of registrational studies for lemzoparlimab and pre-BLA milestones for TJ101 and felzartamab second-line treatment. We are determined to meet these goals and set a solid foundation or even more advanced pipeline development in 2022 next year. Now let me switch again to talk about how our pipeline will create short value and how we can build our future. On Slide 18, while we focus our efforts and resources to deliver on the pipeline to create short-term value, we have made great progress in building our future to transform the company on a clinical stage biotech to a global biopharma. Now, more detailed illustration is on Slide 19. To achieve this goal within the next few years, firstly, we have been upgrading our global R&D and established a new R&D facility in San Diego to focus on translational medicine and formulation to support and facilitate our innovative pipeline globally. Secondly, we are on track with the construction of our manufacturing facility in Hangzhou. The pilot plant will be ready by mid next year and commercial production by end of 2023. As a matter of fact, our PD laboratory has already started to function to take on our CMC projects in Hangzhou. Thirdly, we have built our initial commercialization capability with a core team and a commercial strategy to move forward. The team has already started to prepare for the product launch of felzartamab. Our initial commercial strategy is really to focus on hematologic malignancies by leveraging our unique position with felzartamab as a backbone drug for multiple myeloma. Third line treatments. Second line treatments and potentially first line treatments. Lemzoparlimab as a backbone drug for leukemia AML MDS, as well as lymphoma when combined with a CD19 or CD20 antibody. Currently, we are actively seeking commercial partnerships and in-licensing opportunities to further enrich our initial [indiscernible] focus commercial portfolio to potentially become a leader in the hem hunk therapeutic area in China. And the commercial portfolio for solid tumors will follow after 2024 with uliledlimab and other innovative assets moving from clinical trials towards BLA. Now, I will ask Dr. Shen to discuss about some other items related to awards recognition and how we made efforts to strengthen the company's corporate governance and social responsibilities. Dr. Shen?

Yes, thank you Dr.

Thank you, Dr. Shen. Now let me turn to review our financial results for the six months ended June 30, 2021 that's on Slide 23. First of all, as of June 30, 2021 total cash meaning cash, cash equivalents, restricted cash and short-term investments totaled RMB 4.8 billion or 790 - US$739.2 million compared with RMB4.8 billion as of December 31, 2020. We are very well capitalized for the size of the opportunities in front of us and our vision to become a fully integrated biopharma company. Our strong cash balance provides sufficient funding and the strategic flexibility through major value-creating milestones in relation to TJ202, TJ101, TJC4 and TJD5 over the next one or two years. Now let me turn to the revenue side. For the six months ended June 30, 2021 net revenues were RMB17.8 million or US$2.8 million compared with nil for the six months ended 2020. Revenues generated for the six months ended June 30, 2021 solely consisted of revenues recognized in connection with I-Mab's strategic collaboration with AbbVie and our collaboration with AbbVie has been going very well. Now let me turn to the R&D expenses. Total R&D expenses, meaning the core R&D expenses plus the ESOP related share-based compensation for the six months earlier this year were RMB593 million or US$91.8 million compared with 442.3 million for the same period in 2020. The increase in total R&D expenses was primarily due to the increased CRO service fees to advance the company's broad pipeline, especially for key assets including lemzoparlimab TJC4, uliledlimab TJD5 and eftansomatropin alfa TJ101. Now within the total R&D expenses. As you can see, we've broken down for you the cash versus non-cash expenses, so the non-cash share-based compensation expenses accounted for RMB112.7 million or US$17.5 million for the six months ended June 2021 compared with 132.7 million for the six months ended June 30, 2020. The overall growth in R&D expenses for the six months earlier this year reflected the rapid growth or progress of the company's pipeline assets. Now let me turn to administrative expenses. Total administrative expenses for the six months ended June 30, 2021 were RMB 451.5 million or US$69.9 million compared to RMB171.4 million for the same period in 2020. The increase was primarily due to higher share-based compensation expenses, which we have broken out for you here, increased professional service expenses including one-time expenses and the expansion in payroll as a result of increased headcount, driven by new hires we've made in preparation for the Company's future commercialization and the product launch in China. Within the total administrative expenses, share-based compensation expenses accounted for RMB222 million or US$34.4 million for the six months ended June 30, 2021 compared with RMB97.1 million for the six months last year. One-time expenses, which consisted of listing related expenses and other expenses were RMB69.9 million or US$10.8 million for the six months ended June 30, 2021. There were no one-time expenses - one time administrative expenses for the same period last year. Now if you look at the core administrative expenses without the share-based compensation and the one-time fees, they track the growth in our non-R&D staff base and that the operating footprint very well and demonstrated necessary investment, we are already making for commercialization in China. Now, one more point. The last point on expenses. I would say that the broad expense profile with the core R&D and administrative expenses is highly consistent with our strategic ambition of transitioning into a fully integrated biopharma company built on strong internal R&D partnership, manufacturing and commercialization capabilities. We are investing for the future. Last one on the P&L for the six months ended June 30, 2021, I-Mab reported a GAAP net loss of 1.07 or RMB8 billion or US$166.7 million compared with a GAAP net loss of RMB582.9 million for the same period in 2020. Non-GAAP net loss, which excludes the share-based compensation expenses was RMB729.4 million or US$113 million compared with non-GAAP net loss of 353.1 million for the same period in 2020. Next page. This is the last page in the prepared remarks section. In this page, I want to give you a quick update on where we are in preparing for the dual listings in Greater China. Our Board approved the preliminary listing plan on the STAR Market in Shanghai in late July and we subsequently entered into a tutoring agreement with CICC, one of the most well-known investment banks in China to kick off the process. The tutoring application package was accepted and registered with the Shanghai branch, Shanghai Bureau of the China Securities Regulatory Commission on August the 20th. In the meantime, we are also taking steps to plan an additional listing in Hong Kong's Chapter 18A Market. We strongly believe that the dual listings will broaden and diversify our existing shareholder base. Derisk some of the geopolitical concerns and potentially bring down our overall cost of capital. We expect these dual listings to be completed by the end of 2022. Now with that we'd like to end the prepared remarks for this call and the start the Q&A session. Please ask your question by pressing the raise your hand button in the

Thank you for the detailed in-depth update. Now we will start the Q&A session. So if you have questions, please use the raise your hand function via

Congrats on the progress. And thank you for taking my questions. Lemzoparlimab, what level of detail should we expect for the topline readout of early China trial at ASH and what is the efficacy bar for this program to move forward? And my second question is for the partnership with AbbVie. When will you expect the next milestone payment and also and in solid tumor trials in discussion that will be led by AbbVie in the U.S. Thank you very much.

Yes. Thank you, Kelly. This is Jingwu. Let me first address your first question. Now our U.S. trial of lemzoparlimab in combination with rituximab in patients with non-Hodgkin's lymphoma showed really excellent clinical results. Firstly, it has further confirmed the safety profile of lemzoparlimab and again in this trial, the safety is very good and we did not give patients a priming dose because it was not needed because of the safety profile. Secondly, we observed very encouraging clinical efficacy signals although at this time, I'm not in a position to give you all the details, but as I mentioned, the past few months we submitted abstract to ASH this year and we are prepared to release that clinical data at ASH in November and hopefully if possible, we will find out opportunity to release the data earlier. Now Kelly, let me emphasize three points regarding lemzoparlimab. First of all, internally in terms of the speed of clinical development. As we discussed, our ambition is to launch lemzoparlimab as the first CD47 antibody product in China and also help AbbVie to achieve the global registration and we have been accelerating multiple clinical programs by leveraging the advantages in both U.S. and China. Now, as a result, we have a three parallel lines of clinical development, non-Hodgkin's lymphoma, AML, MDS and solid tumors. And we have made remarkable progress in all three lines. Now, most importantly, we're very excited that the current progress may potentially lead to registrational trials in 2022 next year, and this is a really good speed to move this asset into a late stage or pivotal stage of development. Now, second point is that in terms of safety advantages of lemzoparlimab, so far there are a total of 86 patients have been dosed in the U.S. in the trials in the U.S. and China. The safety profile remains very good and no priming dose is needed in our clinical trials and together they are important clinical differentiation. Thirdly, the third point is in terms of clinical efficacy. We've seen good clinical efficacy signals in solid tumors with monotherapy of lemzoparlimab as we reported last year. We expect to see even better efficacy signals in selected tumor types from our current clinical trials in combination with pembro. Now, this is a combo study and we hope to see a better clinical efficacy signal. We have seen, we have also seen a very encouraging clinical efficacy signals in non-Hodgkin's lymphoma in combination with rituximab, as I mentioned earlier. We submitted this abstract already. At the same time in our abbreviated Phase 2 clinical trial in China, we have also seen very encouraging clinical efficacy signal in patients with AML, MDS in combination with A

Sure. Thank you, Dr.

Thank you for the time. Thank you, gentlemen. Our next question comes from Louise Chen. Please go ahead, Louise.

This is Jen Kim on for Louise, thanks so much for taking our questions and congrats on all the progress. We have one broader question. So there have been a lot of headlines regarding, I guess regulatory uncertainty around China. Can you walk us through how you're navigating through this uncertainty and how you think about your fundamental value as an innovative player in the biotech space? Thanks.

Thank you, Louise. I would ask Jielun to elaborate on this question.

Thank you for the question. A very, a very good question. I'll try to answer your question, perhaps on a - on three to four different levels. First, let me start with the broad macro picture, which we have no control over. But it's important anyways. I think the regulations in China, they are targeting the Internet giants. They show their tendency to monopolize as well as sort of sensitive industries like the tutor industry and the food delivery and so on and so forth. But based on our own experience dealing with regulators and different levels of government in China, we strongly believe that biotech is not only an industry that they would not target, but is actually one of the industries that they are actively promoting. It is very important to realize that biotech industry is one of the high tech industries in China, which will help create lot of social benefits and externalities for the government in China. So it's important to realize that and also because biotech industry is not an industry where foreign ownership is banned or restricted. So most of - as I remember, as far as I can remember all of the biotech companies do not need to adopt a VIE structure or VIE structure, which is also, I believe, one of the topics that brought some concerns from investors. So short answer on the macro picture is we think and I think most of our peers would agree that biotech industry will actually receive increasingly more support from the government in the - from different levels of government in China. And I would add to this point that recently if you look at some of the western KOLs for example Ray Dalio from Bridgewater, the head of MSCI China and the Capital Group, they have all made relatively optimistic remarks about the - what's called the investability of Chinese stock market and also overall the picture about regulation in China. So I would encourage you to look at that as well. I think the second point is in relation to our own business model and the quality of our assets. We have a very, very highly differentiated pipeline. Our pipeline has either no first-mover assets or highly differentiated potentially best-in-class assets, both in China and globally. So we think that some of the issues you may be seeing in China for example the cost containment from the NRDL perhaps in relation to sectors like PD1. We think, we are relatively insulated from that because a, our assets for example CD47 lemzoparlimab, most of the value we think will be coming from China - territories outside of China for example bio partnership with AbbVie and we'll continue to do that for other assets like CD73 and other assets down the road. So if you look at a lifecycle of assets like that, we think the economic value of these assets will not be limited. Most of the value will not be limited to the market in China. Secondly, even in the Chinese marketplace because we're not in crowded or super crowded sectors like PD1 or PD-L1 and maybe others, our experience and the estimation is that because of the highly differentiated nature of our assets and the less crowded competition structure in these segments, we think we will face a less harsh or more accommodative pricing structure in China, even in a Chinese marketplace. So if you combine these two points, we think we're relatively well positioned in terms of dealing with some of the potential headwinds you may see - you may be seeing in the NRDL tendering process. The third point, I want to make is, as I discussed the financial section in the - in early part of this call, we actually, actively diversifying our listing values. So we have kicked off the STAR Market listing process in Shanghai. We're also considering an additional dual listing in Hong Kong, all of that will also help us to manage some of the geopolitical risk and also diversify our shareholder base and I think, potentially or probably will also lower our overall cost of capital. So very, very good. We think, we're making very good moves to manage that part of the risk space. I think, lastly, the - that the biopharma sector, our biotech sector in China has seen some relatively big volatilities in the last few weeks and we're probably no exception to that, but I want to emphasize that the volatility in the stock price has nothing to do with our fundamentals. As you can see, we are making so much progress in the last, in the first six months of this year, we actually making significantly more progress than we thought when we did the business planning at the end of last year or beginning of this year. We are very, very happy with where we are and we are optimistic about the future of this company. We had been in close communication with some of the major shareholders of the company and they share the same view with us and they are - they remain long term supporters of the company. So I want to end on that note and to give the floor back to the host.

Thank you, Jielun. Due to time limitation, we will take one last question. So last question will come from Joe Catanzaro. Joe please.

Great, thanks. Thanks so much for taking my questions and congrats on all the progress. Maybe two quick ones for me. So you guys are pretty active on the BD front with the number of platform related deals in the first half of the year. Jingwu you maybe alluded to it, but other deals could we expect in 2021 and I guess, I'm specifically thinking about uliledlimab and what partner deal terms you're interested in there and maybe whether we could see a potentially similar deal term and structure as the AbbVie lemzo partnership. And then as a follow-up. Dr

All right, thank you, Joe. Great questions, let me first address your first question, on the BD side of things. We are actually working on several assets for potential BD partnerships globally and also domestically in China. The - on the global front, we have been discussing with potential global partners for partnerships for TJD5, uliledlimab, as I mentioned earlier. We're actually in discussion with several other companies for bi-specific antibodies or even newer assets coming from our pipeline. So those deals are very similar to the deals we made last year with AbbVie on lemzoparlimab and we're very excited and moving forward - continue moving forward with those discussions and at one point, we will feel comfortable to release the terms and discuss those deals. So that's one, and on the second front, we are in-turn sheet with several, several companies and we are about to select one company to solidify our commercial discussion for TJ101, our long-acting growth hormone. And this is going to be a big and visible deal in China and exemplifies or signifies how biotech companies like I-MAb working together or partnering with big pharmaceutical groups in China in order to maximize the value of commercial products like long-acting growth hormone. And at the same time, this year, we have successfully closed six, seven BD deals and those are relatively early stage assets, I will talk about Messenger RNA platform, I will talk about complex intracellular platform, so those deals will help us to build the third wave innovation with the super antibodies as mentioned earlier. So, all together, we are very active on the BD front globally and domestically in China and hopefully, before the end of this year, we might be in a position to close a few deals, if not, will be early next year. So, we are quite excited to look forward to it. Now, your second question. As discussed today in our presentation, our pipeline is very innovative and clinically advanced and quite rich with the three waves of innovation. Now in addition to lemzoparlimab, uliledlimab and Plonmarlimab, it highly visible in our pipeline. There are actually few other exciting assets that are making their ways towards late-stage and to the same level of excitements. One is TJ107. We discussed little bit about this particular asset. This is a Phase 2 asset we are working on in China, so we have already started a Phase 2 clinical trial in patients with GBM, and the other clinical trial, we are about to start Phase 2 trial in combination with pembro for cancer treatments. So this is a very exciting asset now moving towards late-stage. By next year, we should have more data to report and it's important to mention that our partner from South Korea has generated quite a lot of data in relation to the role of TJ107 in the treatment of cancers in terms of combination therapy with pembro in patients with triple-negative breast cancer, and we have seen pretty good ORR way above monotherapy with pembro, and they have also seen very good efficacy signals from their trials in patients with GBM. So this is a important asset service moving toward late-stage and it becomes more and more visible, and the other assets is Enoblituzumab, the B7H3 asset is also a Phase 2 asset, we in-licensed from MacroGenics. And we had then quite a lot of internal work with preclinical stage and we pretty much based on all the data, we pretty much picked out how to move forward very quickly to get through Phase 2, Phase 3 and to launch the product and the strategy is quite clear. Now people will hear more about our progress on this particular Phase 2 asset. Now since we have few minutes, maybe I would ask Joan to see whether you have additional points to add.

Okay. Yes, thanks,

Thank you, Dr.

Thank you.

Thank you.

Bye.

Thank you, every one or good day or good night. Bye-bye.