NovaBridge Biosciences

Thank you, everyone. Thank you for standing by and welcome to IMAP 2021 interim business update and the financial results conference call. Earlier today, we issued a press release detailing IMAP'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 IMAP senior management team are Dr. Jingwu Zhang, our founder, chairman and director, and Dr. Zhong Shen, our chief executive officer. Dr. Zhang will provide a high-level overview of our recent achievements and the strategy going forward. He will then highlight the progress we have made in our key clinical programs and upcoming milestones and catalysts. Dr. Shen will then comment on the status of other important clinical assets and corporate achievements. I will then provide a brief summary of our financial results and our preparation for the dual listings in Greater China before we take questions from the audience for Q&A. Now, without much ado, I will turn the call over to Dr. Zan, our founder, to start the call. Dr. Zan?

Thank you, Jordan. Thank you all for joining the call today. We are very excited to report to you the remarkable progress that companies 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 three, our corporate focus is twofold, with an overarching goal to move our clinical pipeline towards a product portfolio. On one hand, we focus on team execution to rapidly advance the pre-PLA and innovative late-stage core assets, such as fail-sat map, TJ-101, TJ-107, lens of polymap, unilaterally map towards PLA or registration of trials. In parallel, we have been developing the next generation of even more innovative immuno-oncology assets through what we call second wave innovation, characterized as a novel or differentiated bispecific antibodies, and third wave innovation, characterized as a superantibody enabled by transformative technologies. 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, from a clinical stage biotech to a global biopharma. In that regard, 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 five, we provide an overview of IMAP'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 registration of trials ongoing, seven phase two, and eight phase one clinical trials in both US and China. Now the focus of our pipeline is placed around the six core assets as highlighted within the red box because of the potential to become highly differentiated medicines if successfully approved. On slide six, I'm excited to report that we have achieved so far 13 pipeline milestones since the beginning of this year, including seven new R&Ds or trial starts, four 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're on track for BLA submission for ferrocitinib in first quarter 2021 this year. Now, on slide number seven, we have successfully completed some registrational trial for third-line Felsactamab for multiple myeloma. Now, the top-line results have met the primary and the secondary endpoints. More importantly, The study has confirmed clinical advantages of filthartumab in terms of shorter injection time, which allows convenient use at an 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 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 registration of trial for second-line treatments 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 R&D to explore a first-line treatment option for multiple myeloma by combining Falsatumab with one of our own clinical assets in our PAPLA. On slide number eight, regarding TGA101, our long-acting growth hormone, the registration of trial is on track for patient enrollment. There are 165 patients to be enrolled, which will be completed by early 2022. And we're very excited by the outlook of the growing growth hormone market in China. And I believe TGA 101 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 turn-sheet stage. We hope to finalize the deal and report back soon. On slide number nine, Lenzopalimab, a highly differentiated CD47 antibody, will have made remarkable progress in clinical developments of Lenzopalimab in both U.S. and China, which we hope will lead to registration of trials next year in 2022. Our ambition is to launch Lansopalimab as the first CD47 antibody product in China and facilitate the global development of our partner, AbbVie, for global registration. Here's the summary. Firstly, Lansopalimab in combination with Rotoximab 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 an 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 the study. We hope that the current clinical trial will lead to a registration of study for non-Hodgkin's lymphoma in 2022. Secondly, Lansopalimab in combination with AZA for AML-MDS. IMAP is on track to complete an abbreviated Phase II clinical trial in China. As the clinical trial is progressing, we have already seen encouraging early clinical efficacy signals, and we are very excited about that. We plan to complete all the patient enrollments within this year, and I hope that the current study will also lead to another registrational trial in 2022 in China. In the U.S., our partner, AbbVie, is conducting a global clinical trial with ACA and venetoclax in patients with AML-MDS patients. And we are very pleased to mention that we have been working together very well with AbbVie. Thirdly, Lenzopalimab in combination with PEMBRO for solid tumors. Our U.S. trial is progressing to include more cancer patients for better clinical efficacy assessment. More complete clinical data will be hopefully available by the end of this year or early next year. we will report clinical data by that time. In China, we have obtained R&D approval to start a phase two clinical trial with a basket design to focus on selected tumor types that we believe are more susceptible to this combo treatment. To summarize, in terms of safety, so far, a total of 86 patients in US and China have been dosed with the drug. and the safety profile continues to be very good. Here I wanted to emphasize that for Lansopalima, no priming dose is needed throughout. We remain very excited and confident with more clinical efficacy data coming out from multiple clinical trials Our current goal is to focus on team execution to facilitate clinical trials in both U.S. and China so that we will be in a better position to potentially initiate registration of studies in 2022. On slide number 10, regarding ulilatinib, our highly differentiated CB73 antibody, Our U.S. Phase I clinical trial in combination with Atezo, a PD-L1 antibody for solid tumors, was completed early this year. We're very excited by the clinical data and presented detailed results at ESCO this year. In short, the ORR observed with the Eulalacrimab in combination with Atezo is the highest among all clinical studies. as we are aware of. We believe this may be attributable to the differentiated property of ulilaginimab as it is designed to avoid the hook effect. Now, ulilaginimab is safe and well tolerated. RP2D at 20 milligram per kilo is determined. It is also important to note that there's a good correlation between clinical response and a higher CD73 expression in the biopsy tumor specimens. Now, the three tumor specimens with a higher CD73 expression match exactly with the three clinical responders. And they are the same patients as shown in the three red dots on the lower middle figure on slide number 10. And this is very exciting because it may provide the opportunity to stratify cancer patients who are more suitable to this combo therapy in order to increase the probability of success. We'll be moving ahead to start a phase two clinical trial in solid tumors in U.S. this year. and continue to complete the current phase two clinical trial in China in solid tumor. And we will have more data to share next year. On a separate note, we're in continued discussions with selected pharma partners for potential global partnership for ULILAC and IMAP. Now, I will ask Dr. Sen to elaborate on the progress in TGA107, our long-acting interleukin-7 for cancers, and the promolimab, our GM-CSF antibody for cytokine release syndrome associated with severe COVID-19. Dr. Sen.

Thank you, Dr. J. So, yeah, for our promolimab in TGA107, M2, as we have revealed earlier this month, our interim analysis results from our phase two, three studies. This is a study designed for treating the cytokine releasing syndrome associated with severe COVID-19. And the primary endpoint and second endpoint from the interim analysis have shown very positive trends. So in particular, the patients without ventilation and baseline, a positive trend of 7% differences has been observed in treatment group of inverse placebo, which is very comparable to the effect size observed in Linzillumab, which is another GMC-SF from Humanigen. And the mortality rate is 5% in Promolimab, comparing with 13%. in placebo arm by day 30. And then approximately 10% improvement in recovery rates by day 14 and then day 30 in Promonimab compared with placebo arm. So all of these are very major primary and secondary endpoints. And then safety-wise, it's well tolerated. And then also it's worth to note that the biomarkers listed in the slides have shown positive trends also towards the clinical outcome. So moving forward, considering the Delta outbreak still ongoing in U.S. and other countries, we're continuing these phase two slash three studies in the United States. But in the same time, we're also seeking to explore additional indications associated with CRS. Particularly, we are in preparation for CRS associated with sepsis led by Professor Zhang Wenhong from Hua Shan Hospital in Shanghai. And then our IMD is prepared to submit before the end of this year. Next. Slide 12. Yeah. So for this, our infineptokine and alpha, which is TG107, we have been licensing from our partner GenXen from Korea. Since then, we have conducted two studies. First is phase 1B studies for the patients with lymphopenia after chemo or radiation therapies. And these studies, the full results, have demonstrated its safety profile and PKPD correlations. And the full data set has submitted to Cisco this year, and it will be published then. The second study is our GBM study is for a phase two studies for the GBM patients. This has been in a full enrollment of this year. And then another exciting news is our partners, Genesys and its subsidiaries and NIT have issued a very exciting results, both in GBM and also in another study, treatments in combination with PD-1. So based on those data sets, we are in full preparation for the third studies, which is for also pembrolizumab combination therapy in our additional studies in solid tumors as a best child design, in particularly to look at the TMBC and head and neck cancer patients, and also guided by biomarkers. So these studies will also be initiated towards the end of this year. So I will give back to Dr. Zhang to continue the rest of the presentation. Dr. Zhang, please.