NovaBridge Biosciences

And ladies and gentlemen, thank you all for standing by. And I'd like to welcome you all to the IMAP Biopharma Full Year 2021 Financial Results and Business Update Conference Call. This is Tyler Ehler here, IMAP Senior Director of Investor Relations. At this time, all participants are in a listen-only mode. Later, we'll conduct a Q&A session and instructions will follow at that time. Earlier today, we issued a press release providing a review of our financial results for the full year ended December 31st, 2021, as well as an overview of our recent corporate highlights and upcoming milestones. The press release can be accessed on the investors portion of our website at ir.i-mabbiopharma.com. Joining me today on the call from IMAP senior management team are Dr. Jinglu Zhang, our founder, chairman, and acting CEO of IMAP, Dr. Andrew Zhu, our president of IMAP, Mr. John Long, CFO of IMAP, and Mr. Jialun Zhu, Chief Strategy Officer of IMAP. Dr. Zhang will start by providing a high-level overview of our recent achievements and upcoming milestones, followed by Dr. Andrew Zhu, who will provide an update on our R&D progress, and Mr. Zhu, who will provide an update on our commercialization capabilities. Mr. Long will then provide a summary of our financial results for the full year ended December 31st, 2021, before we turn the call to the operator to take your questions. Please note that today's discussion 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. The general discussion of the risk factors that could affect IMAS business and financial results is included in certain filings of the company Securities and Exchange Commission. The company does not undertake any obligation to update this forward looking information except as required by law. We'll also discuss specific non-GAAP financial measures for comparison purposes only during today's call. Please see the financial results news release issued earlier today for definition of non-GAAP financial measures and a reconciliation of GAAP to non-GAAP financial results. With that, I'd like to turn the call over to Dr. Jim Woodson, our founder Chairman and Acting CEO. Dr. Zeng, please go ahead.

Thank you, Tyler. Thank you to everyone for joining us. It's a pleasure to welcome all of you to our call today to discuss our business updates and financial results for the full year 2021. Now, I must say 2021 was a dynamic year for IMAP. we made remarkable progress in a short period of time and closed the year with stronger fundamentals than we have ever had before. Firstly, on the pipeline development front, we met 20 key clinical milestones, including the successful completion of our registrational trial for Felsatomab as a third-line therapy for multiple myeloma. We're now in the process of submitting the BLA package in China. We also achieved positive data readouts for two of our key assets, lansopalimab and ulilapidemab, including the latest clinical data from our ongoing MDS trial, which will be discussed today in detail by Dr. Andrew Zhu. As a result of the progress made in 2021 and the continued progress in 2022, we expect to advance our pipeline to include three or four registrational trials, 11 phase two clinical trials, and three phase one clinical trials by the end of 2022. Our pipeline has progressed to a completely different stage as compared to that at our IPO two years ago. It's not only globally innovative with a potential best-in-class assets such as Lanzo PolyMap and Uli Ladrimap, but also advancing towards near-term BLA and product launch within the next three years. Secondly, on the corporate development front, in 2021, we entered into seven partnership deals, including the $350 million strategic commercial partnership with Jumpcan for Iftan Sumatropin Alpha, our long-acting growth hormone, and a partnership with Roche Diagnostics. Now, these partnership deals are critical to enrich our pipeline with the next generation of novel drug candidates in preparation for our near-term commercialization. Now, I would like to emphasize that we maintain a very strong cash position with $671 million cash on hand. On top of that, We will continue to receive expected milestone payments from the existing our licensing deals, including the $2 billion deal with AbbVie, the jumping deal and others. This has generated very significant cash flow. Combining the two, our cash is sufficient to fund business operations through 2025 for about three years. Now, on the capital market front, our CFO, Mr. John Long, will address regulatory concerns facing ADR companies on today's call. I just want to first say that we have seen positive signals that regulators from China and the U.S. are working towards a resolution. But more importantly, John will tell you more updates on the active measures we have been taking to mitigate the potential risk by making necessary changes to switch to a U.S.-based auditors that are recognized by U.S. PCLOB. And there are successful examples with other ADR companies. So it can be done. Thirdly, I'm very excited to tell you that our pipeline has advanced to a critical phase where we are approaching near-term commercialization. This is a transformative step for IMAP. Pending the finalization process, of an in-licensed pre-BLA product, we expect to file four BLAs, followed by a product launch between 2022 and 2025. Now, this near-term product portfolio is focused on hematologic oncology with filacitimab, Lansopalimab and an in-licensed product as a core product to cover multiple myeloma, leukemia, and the lymphoma. Additionally, we expect that if there's somatropin alpha, our long-acting growth hormone will become a major player in China's growth hormone market for its product differentiation and convenience of use. Now, commercialization of this near-term product portfolio is a critical step in IMF's journey to transition from a global biotech to a specialty biopharma with global R&D manufacturing and commercialization capabilities. It is expected that our current revenue stream from our licensing milestone payments will soon converge with our product sales revenue to generate significant cash flow for the company. Therefore, a large part of our current corporate focus is really to prepare for the near-term commercialization under the leadership of Mr. Yifei Zhu, our chief commercial officer. Now, looking ahead, 2022 is shaping up to be an even more exciting year for IMAP. We continue to consolidate our position as a leading global biotech company in the immuno-oncology space and strive to transition into a global specialty biopharma. We are set to achieve a series of high impacts and value generating milestones and catalysts, which I will summarize for you at the end of this call. Now, with this quick overview, I would like to ask Andrew to take a deep dive into our key pipeline assets and provide our expectations for 2022. Andrew, over to you.

Thank you, Jingwu. It is really my pleasure and privilege to speak with all of you today. The focus of my discussion will be on our pipeline development in terms of the recent progress and updates, as well as the near-term prospect of our exciting pipeline. With the progress made, it has become apparent that our pipeline is not only globally innovative, but also advanced, with 10 clinical assets that are either novel or highly differentiated. Our first wave of innovation focuses on highly differentiated monoclonal antibody of best-in-class potential, such as LentoproteinMab and UriLedlimab. which will have now entered phase two and phase three clinical trials by year end. The second wave innovation focusing on by specific antibodies of both first-in-cause and best-in-cause potential, such as L1-4B and CD4B, are now in early stage clinical development. There will be more to come. The pipeline is also advanced as Felsartimab, Lenzoproteinab, and Eftenzometropin-alpha are either in registrational studies or have already reached the BLE stage. They will soon become the core products of our near-term commercialization. Today, I would like to take this opportunity to highlight seven key assets in our pipeline because they are value drivers. These assets are novel, highly differentiated, and are among the front runners globally or in China. I will go through each of them in more details. I'd like to start by reviewing our highly differentiated CD47 antibody Lensil Pralimab first. This has attracted so much attention in the immuno-oncology field because of its potential as a best-in-class CD47 antibody and is leading position among the first CD487 antibody drugs potentially to be approved for hematological malignancies. I would like to remind you that LEMZO is differentiated by design to avoid binding to red blood cells while maintaining strong anti-tumor activity. This molecular differentiation has been validated preclinically and has translated to clinical advantages that are being validated. IMAP's priority for LEMZO is to achieve its first registration of LEMZO polyMAP in its class in China and facilitate global development in close collaboration with AbbVie for global registration and commercialization. To achieve this goal, five clinical studies of LEMZO are ongoing in parallel, both in US and China. We are running three clinical programs with LEMZO in China, including NHL, AML, MDS, and solid tumors. In addition, our global partner, APVI, is running two clinical programs globally. Based on the clinical data being generated, we hope to initiate one or two registration trials with LEMZO PolyMAP this year for MDS and potentially NHL. Recently, Gileas migrolimab has been put on clinical hold due to ASUSA. As I mentioned earlier, LEMZO is designed to avoid the hematological toxicities. We recently conducted a systemic safety data review of 180 patients who were treated with LEMZO in various combinations. Of these, over 70 patients with MDS or AML have been treated in combination therapy with azitidine. Overall, the safety data from both the US and China studies continue to be favorable when administered without a priming dosing regimen, which is consistent with LEMZO's differentiation. Among different combinations and across different indications, Lamzoparmaz MTD was not reached in any dose regimens. As of today, the majority of TRAE in solid tumors and NHL were grade 102. In AML-MDS, the CT profile as a monotherapy and in combination with ACA was favorable as expected, and no grade 5 hematological TAEs have been reported. We remain very encouraged by the therapeutic potential and safety profile of LEMZO polymath. This favorable safety profile with LEMZO continue to build our confidence in rapidly moving this program forward to its registration studies. In terms of efficacy of LEMZO, three clinical trials are summarized here with the MDS and the phase two studies to be finalized. Efficacy signals have been detected at higher-dose cohorts in monotherapy in patients with advanced and refractory solid tumors. In a smaller group of solid tumor patients who were previously treated with PD-1 therapy, both PR and SD were detected. Ongoing phase 2 studies with LEMZO is combined with PD-1 therapy in solid tumors in both the U.S. and China will provide more efficacy data. In a recent clinical trial where Lenzo is combined with rituximab for NHL, we observe encouraging clinical efficacy. Of seven available patients, CR rate is 57%, ORR 71%, and DCR is 100%. We expect to report more data in the second half of 2022, and may potentially initiate a registration trial in patients with NHL in China pending approval by the NNPA. I'm now very excited to report to you the most recent preliminary clinical data on lentoprotein map combination therapy with AZA for MDS. In a preliminary analysis of 47 newly diagnosed MDS patients on treatments for various durations, The preliminary data showed that the overall response and complete response rate in 22 MDS patients with medium treatment duration of at least four months is comparable to that of migrolimab. The complete data analysis is expected in June 2022, when all data are matured. We're very encouraged by the data and plan to present the full story at a selected scientific conference in the second half of 2022, and start a registration trial this year pending approval by the NMPA. Next to ulilidlimab, another global frontrunner that we're developing for solid tumors. As previously reported, ulilidlimab is differentiated by design to avoid the hook effect. In a recent study where patients with solid tumors were treated with ulilevimab in combination with the T-cell, among 13 available patients, ORR is 23% and DCR is 46%. While the results are preliminary, they are very encouraging. We are conducting two phase two clinical trials in both US and China and hope to share the data as soon as available this year. I also want to mention that alongside planned data readouts this year, we continue to explore the global partnership opportunities. Next is falzartimab, our most advanced asset. We have successfully completed a registration trial in China for falzartimab as a third-line treatment for multiple myeloma. Our study confirmed the efficacy of Felsartimab with additional benefits such as shorter infusion time, lower infusion-related reaction rate, and no severe infusion reaction. This allows the use of Felsartimab in all patient clinic settings. We plan to schedule a meeting with regulatory authorities and aim to file a BLA together with a local manufacturing firm. In terms of the second-line treatment of falzartumab in combination with lenalidomide for multiple myeloma, we have completed enrollment in our pivotal phase three study and are waiting for the data to mature to support our BLA submission in 2023. We also expect to initiate a new clinical trial of falzartumab with lemdoprolimab as a potential first-line treatment for multiple myeloma. Next is the Aftenzometropin-α-OTJ101 or differentiated long-acting growth hormone as a weekly treatment versus the commonly used daily injections. Our registration phase three TOLER trial is ongoing. We are on track to complete the target enrollment of 165 patients in Q2 2022 and are on track for BLA submission in late 2023. In 2021, we entered into a strategic commercial partnership with Jump Can to leverage Jump Can's vast commercial network as a commercial leader in the pediatric therapeutic area. Our agreement includes upfront and potential milestone payment of $315 million, as well as a 50-50 profit sharing or low double-digit royalties on revenues. This partnership represents one of China's biopharma market's largest deals, which is a testament to the product's potential, as well as to IMF development capabilities. Another novel compound in our pipeline, TJ107-OF-Neptekin-Alpha, is the world's first and only clinical state long-acting recombinant human interleukin-7. This asset is positioned as a monotherapy for the treatment of cancer patients with lymphopenia because of its unique properties of increasing tumor attacking T-cell numbers and as a combination immunotherapy with a PD-1 or PD-L1 antibody because of its potential synergism with PD-1, PD-L1 therapy. Currently, we're conducting two phase two clinical trials in China. It is important to mention that the next thing is clinical trials in the U.S. have provided some encouraging efficacy signals for both TBM as a monotherapy and triple negative breast cancer as a combination therapy with pembrolizumab. We are also developing inoplituzumab. a world's leading humanized B7H3 antibody as an immuno-oncology treatment agent. Inoperatuzumab works through a unique dual mechanism and has exhibited the potential to treat multiple solid tumors. Our partner Microgenics has previously shown promising preliminary data in non-small cell carcinoma of head and neck and non-small cell lung cancer Currently, we are conducting a phase two basket trial in combination with PD-1 in patients with selected solid tumors, including non-small cell lung cancer and urethelial carcinoma in China. Our bispecific antibodies have made significant clinical progress as well. Of note, TDA-CD4B is a normal clotting 18.2 and 4-1BB bispecific antibody capable of binding to tumor cells expressing clotting 18.2 and stimulating intratumoral T cells by the 4,1-BB arm, which is designed to become active only upon tumor engagement to avoid systemic toxicity. IMAP recently received FDA often drug designation status for CD4B for the treatment of gastric cancer, including cancer of gastroesophageal junction. As one of the core assets in our highly innovative bispecific antibody pipeline, CD4B is currently undergoing phase 1 clinical trials in both the U.S. and China in patients with advanced solid tumors. In the ongoing dose escalation study, CD4B was found to be safe and well-tolerated at a dose up to 3 mg per kid weekly. While we advance the clinical development of this compound, we plan to share more data as they become available. To summarize, IMAP has a powerful discovery engine with innovation in three waves. Most of the first wave of monoclonal antibody are in POC and registration trials. The second wave of bispecific antibodies are in phase one and preclinical studies. In addition, our third wave of even more innovative assets enabled by transformative technologies, such as mRNA technology, cell-penetrating alpha body technology, locally activated pro-body technology, and AI protein design technology are in preclinical stage and CMC stage. The third wave of transformative molecules in the discovery and preclinical stages and will reach an R&D stage in 2023. With that review, I will turn to Mr. Jielun Zhu to provide you with more insight into our commercial development.