5/11/2022

speaker
Operator
Conference Operator

Stand by. We thank you for your patience. Today's conference is scheduled to begin shortly. Please continue to stand by. We thank you for your patience. Thank you. Thank you. Thank you. Hello, ladies and gentlemen. Thank you for standing by and welcome to Xylep's first quarter 2022 financial results conference call. At this time, all participants are in the listen-only mode. Later, we will conduct a question and answer session and instructions will follow at that time. As a reminder, today's call is being recorded. It is now my pleasure to turn the floor over to Billy Cho, Chief Financial Officer of Xylep, who will make introductory comments.

speaker
Billy Cho
Chief Financial Officer

Thank you, operator. Good morning, good evening, and welcome, everyone. Xyleb recently issued a press release providing the details of the company's financial results for the first quarter ended March 31, 2022, as well as product highlights and corporate updates. The press release is available in the investor relations section of the company's corporate website at ir.xylebatory.com. Today's call will be led by Dr. Samantha Duke, Zalash founder, chairperson, and chief executive officer. She'll be joined by Dr. Alan Sandler, president and head of global development oncology, who will discuss advances with our oncology product candidates. Dr. Harold Reinhart, president and head of global development, neuroscience, autoimmune, and infectious diseases, who will speak about progress we have made in those three therapeutic areas. And I will discuss the performance of our market products and conclude with comments on our financial results. Additional executives will also be available to answer questions during the Q&A portion of the call. As a reminder, during today's call, Dylab will be making certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including our business plans and objectives and timing and success of our clinical trials, our sales and revenue forecasts for our products and product candidates, regulatory applications, and commercial launches. These forward-looking statements are not guarantees of future performance. and therefore you should not put unduly lines upon them. These statements are subject to numerous risks and uncertainties. Actual results could differ materially from what we expected due to a variety of factors, including those discussed in our SEC filings. At this time, it is my pleasure to turn the call over to Dr. Aleph Stoller, Chairperson and Chief Executive Officer, Dr. Samantha Du.

speaker
Dr. Samantha Du
Chairperson and Chief Executive Officer

Thank you, Billy. Hello, everyone, and thank you all for joining us today. Our first quarter results reflect Xi's solid foundation and track record of consistent execution and were marked by progress across the entire portfolio. To kick off today's call, I'd like to highlight the progress made on Xi's proprietary pipeline, which consists of 11 internally developed methods with global rights. Building upon last year's proof-of-concept treatment for GL1102, our anti-L17A human body for chronic plaque psoriasis, I recently unveiled preclinical data from four key young hazard programs at the 2022 AACR Annual Meeting. With this asset, just beginning to enter first-in-human and proof-of-concept clinical studies, we're in the exciting early days of demonstrating Tsai's commitment to in-house discovery and translational research. And of course, this proprietary pipeline complements the advancements within our latest partner pipeline which is expected to produce numerous pivotal study readouts through 2022. As you may recall, at the beginning of this year, we established 2022 strategic priorities that aimed to lead the next wave of biopharma innovation. I'm pleased to say we continue to progress toward achieving these priorities, including progress toward filing the NDA for FGT-MOD in China in mid-2022, initiation of a registration study for bimethylamine with first-line gastric cancer in Greater China, and top-line data readout for CAR-ST from a phase III emergency trial by third quarter 2022 We continue the investment in R&D to advance our proprietary pipeline with global rights, including moving CL1102 into full global development. Importantly, our commercial team continues to drive significant growth with our full market products in Greater China. Before turning the call over to Alan to discuss our oncology franchise in more detail, I'd like to make a brief comment on the ever-evolving COVID-19 situation in China. Tsai continues to monitor the potential impact in certain regions in China, while COVID-19 did not have a significant impact on our business in the first quarter. has presented access difficulties which we believe are likely to have a modest impact in the second quarter in China. Even so, we remain very confident in the underlying strength of our business despite the COVID-19 situation in China and the current macro and geopolitical hazards The fundamental drivers of value at TriLab have further strengthened our expanding leadership team, global talent, and our ever-growing pipeline. The steps we have taken to facilitate access to global capital markets and our track record of consistent execution in putting global first-in-banking costs and assets to patients in China and beyond We at Xilab remain committed to pursue our overall goal of improving human health worldwide and to build a leading global biopharmaceutical company. Now I'd like to turn the call over to Dr. Alan Sandler. Alan?

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