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I-MAB

Q42022

3/31/2023

speaker
Tyler Ehlich
Senior Director, Investor Relations

Good morning to everyone, and thank you for joining us this morning. Thank you all for standing by, and I'd like to take this opportunity to welcome you all to the IMAP Biopharma Full Year 2022 Financial Results and Business Update Conference Call. This is Tyler Ehlich here, IMAP Senior Director, Investor Relations. At this time, all participants are in a listen-only mode. At the end of this call, we'll conduct a Q&A session, and instructions will follow at that time. Earlier today, We should have press release providing a review of our financial results for the full year ended December 31, 2022, as well as an overview of our recent corporate highlights and upcoming milestones. The press release can be accessed on the investor relations tab on our website at ir.i-mabbiopharma.com. Joining me today on the call from IMAP senior management team are Dr. Jingwu Zhang, our founder and chairman, Dr. Andrew Zhu, our acting CEO, and Mr. Richard Ye, our interim CFO and COO. To start, Dr. Andrew Zhu will provide a high-level overview of our recent achievements and upcoming milestones, also provide an update on our R&D progress. Mr. Ye will then provide a summary of our financial results for the full year ended December 31, 2022, Before we turn the call over 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 made under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Such statements are not guarantees of future performance and are subject to certain risks and uncertainties, assumptions, as well as 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 in today's discussion. The general discussion of the risk factors that could affect IMAD's business and financial results is included in certain filings of the company of the Securities and Exchange Commission. The company does not undertake any obligation to update this forward-looking information except as required by law. We also discussed specific non-GAAP financial measures during today's call, the presentation of which is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with U.S. GAAP. Please see the financial results press release issue today for a definition of non-GAAP financial measures and a reconciliation of GAAP to non-GAAP financial results. And with that, I'll now turn the call over to Dr. Andrew Drew, our acting CEO. Dr. Drew, please go ahead.

speaker
Dr. Andrew Zhu
Acting CEO

Thank you, Tyler. It's a pleasure to welcome all of you to our call today. I want to take this opportunity to discuss our key business update and major progress in core asset development for the year ended December 31st, 2022. Since the start of 2022, the company faced multiple challenges. including but not limited to geopolitical issues, such as ADR delisting risk, macroeconomics factors, including interest rate hikes, and the 2019 pandemic. In response to these challenges, the company made several strategic efforts to reposition the overall business and prioritize its pipelines. These measures resulted in a streamlined corporate structure and workforce, as well as focused development of five key assets leading to a significant reduction in the cash burn rate in 2022 and beyond. These efforts have allowed us to achieve critical milestones for our prioritized pipeline and deliver near-term value. In terms of the ADR delisting risk, on December 15th, 2022, the PCAOB issued a report that violated the previous determination and removed mainland China and Hong Kong from the list of jurisdiction where it is unable to inspect or investigate completely registered public accounting firms. For this reason, the company does not expect to be identified as a commission-identified issuer under the HFCAA. Operate files the annual report on Form 20F for the fiscal year 2022. This has removed a significant headwind the company faced in 2022. With the above-mentioned strategic efforts on the pipeline development front in 2022, we achieved 13 key clinical milestones, including positive results, including positive data readouts for three of our key assets, Lenzopartimab, Ulileptimab, and Gevastomic. Here, we highlight the five key clinical assets that we have prioritized. These assets are novel, highly differentiated, and among the front runners globally and all in China. First of all, Afkentometropin-R for our long-acting growth hormone. We completed the enrollment of 168 patients for our phase three trial in the first half of 2020. We expect to have a data readout in the second half of 2023, followed by subsequent BLA submission. In November 2021, we announced a commercial partnership with Jump Can, a top 100 Chinese pharmaceutical company specialized in the pediatric space. Second, Belzarvimab, a differentiated CD38 antibody. In addition to the completed Phase II registration study, our Phase III study for second-line multiple myeloma is on track, despite the impact of COVID-19. Continue to make progress with the local manufacturing plant in preparation for BLH decision and seek a potential commercial partnership. Next, we have three key assets that I will discuss in more detail later. Lenzoparlimab, a differentiated CD47 antibody, has reached the phase three stage. Ulileptimab, a differentiated CD73 antibody and a global front runner, has demonstrated impressive anti-tumor activity in non-small in a phase two trial. The clinical response is correlated with tumor CP73 expression. Next, GeoStomach, a clotting 18.241BB bispecific antibody with a failure safety profile and single agent efficacy signal. I would like to start by highlighting our highly differentiated CD47 antibody, Lenzoparimab, which has certainly attracted so much attention in the immuno-oncology field because of its leading position to be among the first CD47 antibody drugs potentially approved for hematological malignancies. I would like to remind you that lemzoprotein map is differentiated by design to avoid binding to red blood cells while maintaining strong anti-tumor activity. This differentiation includes the expected favorable safety profile with no priming dose required, less RBC-mediated syncytified, and compelling anti-tumor activity across several This molecular differentiation has been validated preclinically and has translated into clinical advantages that are being validated. I should also add in September 2022, AbbVie and IMAP entered into an amendment to the original license and collaboration agreement. As a result, both parties are continuing to collaborate on the global development of anti-CD47 antibody therapy. Here I want to highlight lemzoprotein map safety differentiation with clinical data. In a systemic safety data review of approximately 200 patients who were treated with lemzoprotein map, either as monotherapy or in various combinations. We have seen a compelling safety profile today. Overall, the safety data from both the US and China studies continue to be favorable when administered without a priming dose regimen. MTD was not reached in any dose regimen, mild TRE in solid tumor and NHL, And we have seen a good safety profile in combination with azacitabine in AML and MDS. And no grade five hematological TRIs have been reported. In the phase two study in MDS, we have observed a favorable safety profile shown on the right. Of note, this study enrolled more patients with worse baseline conditions than the comparable clinical trials conducted in Western countries due to the underlying disease that is heavily influenced by clinical practice in China. In this group, 74% of patients had a grade three and above anemia. and 51% of the patients had grade 3 and above thrombocytopenia at baseline. The overall safety results showed that lemzoprotein map, even without the priming dose, was well tolerated in combination with acidity, and the safety profile was comparable with that of acidity monotherapy. Next, I would like to highlight the clinical efficacy results presented at ASMO 2022. Of the 53 patients enrolled as of March 31st, 2022, for patients who began treatment six months or longer prior to the analysis, the overall response rate and complete response rate were 86.7% and 40% respectively. For those who began treatment four months or longer, the ORR was 86.2% with a CRR of 31%. I'm happy to share that the updated results from the most recent data analysis of 62 patients have demonstrated consistent clinical efficacy, including ORR and CRR, with no new safety signals identified. We are planning to present the updated data at a major scientific meeting in the second half in 2023. Here, I would like to summarize the key progress on Lenzopartimab. We have observed consistent and favorable safety profiles in more than 200 patients with hematologic and solid tumors treated with Lenzopartimab. Our Phase II MDS trial demonstrated a consistent efficacy trend, including ORR and CR, with a longer follow-up time since the asthma data presentation in September 2022. Lenzoharumab, in combination with azazitidine, has obtained approval from the CDE to initiate a Phase III regulatory trial for the first-line treatment for patients with newly diagnosed higher-risk MDS. Importantly, AbbVie and IMAP entered into an amendment to the original license and collaboration agreement As a result, both parties are continuing to collaborate on the global development of anti-CD47 antibody therapy. Next, I'd like to turn to Unilever, another global frontrunner that we are developing with a focus on non-small cell lung cancer. As previously reported, Unilactamimab is differentiated by design to avoid the hook effect. So what is the hook effect? Simply put, the hook effect is characterized by an abnormal phenomenon that a drug molecule paradoxically loses the effect at higher doses. As shown in the figure on the right side, Ulelecumab achieved complete enzymatic inhibition without the hokey fat. In contrast, olecumab could only achieve partial inhibition with hokey fat with higher concentrations. Ulelecumab's differentiation comes from a unique binding epitope at the C-terminus, We believe the differentiation gives the UDLivimab the potential to be best in class with an improved therapeutic window and more flexibility when combined with other anti-tumor drugs. We have observed robust efficacy data in stage 4 non-small cell lung cancer with high CD73 expression, and we are currently conducting, focusing our efforts on a biomarker-guided people-to-trial in advanced non-small cell lung cancer in the second half of 2023. So on the left side of this slide is our PK study. It really demonstrated linear PK profiles at five milligram per kilogram weekly or higher, indicating target separation. At 30 milligram per kilogram, saturation and complete inhibition of CD73 activity were observed in human tumor biopsy samples. Studies of uv-lethemimab in combination with an anti-PD-1 or PD-L1 have shown treatment is safe and well tolerated with no dose-limiting toxicities observed. Most treatment-related adverse events were either grade one or grade two. Uv-lethemimab RP2D has been determined to be 30 milligram per kilogram every three weeks in combination with toripalimab at 240 milligram every three weeks. This slide highlights the clinical experience of our U.S. phase one study of ulipalimab in combination with the tizolizumab in patients with refractory solid tumors. Among 13 efficacy-evaluable patients, three responses were seen, including one PR, with an overall response rate at 23% and the disease control rate at 46%. More importantly, shown on the right, all three responders were identified to exhibit higher expression of tumor 73, CT73, as compared to non-responders. This provides the initial indication that high CD73 expression may correlate with the clinical activity of UD LatinMAP. Here, I want to highlight the latest clinical development update on UD LatinMAP. As of December 2022, 70 patients had been enrolled in the phase two study of urilatumab in combination with toripalimab, a PD-1 antibody, in stage four non-small cell lung cancer patients. As a high level of summary, at the time of the first data cutoff in March 2022, ORR was 26% and the DCR was 74% for the first 19 evaluable patients. Remarkably, in patients with high CD73 expression defined of at least 35% expression level in tumor cells or immune cells, a much higher ORR was observed with a 57% ORR and DCR at 100%. Similar efficacy data in relation to CD73 expression were obtained in August 2022 with 32 evaluable patients and December 2022 with 45 evaluable patients, showing a consistent trend of efficacy signal with an overall ORR greater than 30% in all patients and an ORR approximately 50% in CD73 high expression patients as compared to approximately 10 to 15% for those with CD73 low expression. The advocacy data continue to mature for ORR and PFS in 2023. Our data have demonstrated that higher clinical response of ulilactamab and PD-1 combination therapy correlated with high tumor CD73 expression in patients with advanced non-small cell lung cancer.

speaker
ulilactamab

I want to summarize the key development of ulilactamab on this slide.

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