8/7/2025

speaker
Operator

Hello, ladies and gentlemen. Thank you for standing by, and welcome to Xylep's second quarter 2025 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 Christine Cho, Senior Vice President of Investor Relations. Please go ahead, ma'am.

speaker
Christine Cho
Senior Vice President, Investor Relations

Thank you, operator. Hello and welcome, everyone. Today's earnings call will be led by Dr. Samantha Du, Xilab's founder, CEO, and chairperson. She will be joined by Josh Smiley, President and Chief Operating Officer, Dr. Rafael Amado, President and Head of Global Research and Development, and Dr. Yajing Chen, Chief Financial Officer. Jonathan Wang, our Chief Business Officer, will also be available to answer questions during the Q&A portion of the call. As a reminder, during today's call, we will be making certain forward-looking statements based on our current expectations. These statements are subject to numerous risks and uncertainties that may cause actual results to differ materially from what we expect due to a variety of factors, including those discussed in our SEC filings. We will also refer to adjusted loss from operations, which is a non-GAAP financial measure. please refer to our earnings release furnished with the SEC on August 7, 2025, for additional information on this non-GAAP financial measure. At this time, it is my pleasure to turn the call over to Dr. Samantha Du.

speaker
Dr. Samantha Du
Founder, Chief Executive Officer and Chairperson

Thank you, Christine. Good morning and good evening, everyone. Thank you for joining us today. As we reach the midpoint of 2025, satellite is entering a pivotal phase. killing our commercial business, advancing our global pipeline, and executing on the goals we outlined at the beginning of the year. Our long-term vision of becoming a leading global biopharma remains strong, grounded on consistent execution and meaningful progress across the business. We are reaffirming our full year revenue guidance of $560 million to $590 million USD. We remain on track to achieve profitability in the fourth quarter, a milestone made possible by the efficient, scalable model we have built over the years. In our original business, momentum is building as we head into a period of significant growth supported by multiple new term launches. This includes pipelining the product opportunities like ZipGuard in multiple autoimmunocations and povitacacept, a dual-bath APOE inhibitor with broad potential. We also anticipate approvals for CARX-T in schizophrenia and Tdac in cervical cancer, both currently under regulatory reviews in China. We're preparing for submissions for other later stage assets, including bimethylamine for cancer and tumor treatment fields for pancreatic cancer. Combined with our broader regional pipeline, these programs position us well for long-term growth. On the global R&D front, we're advancing a pipeline of innovative, globally competitive programs. GL1310, our DL3 ADC, continues to demonstrate first-in-class and best-in-class potential in small cell lung cancer, as illustrated by the updated data presented at ESCO. We also see encouraging early signals in other difficult-to-treat tumors, such as neuroendocrine carcinomas. Beyond that, we're advancing our next wave of innovative global programs into the clinics, including GL1503, a bi-specific R13R31 study for atopic dermatitis, and GL6201, our RRC15-ADC for solid tumors, This development continues to be a core pillar of our growth strategy. As global interest in China-originated innovation rises, Zalas is uniquely positioned to act as a bridge between China's thriving bio-ecosystem and global markets. Our deep local know-how and global R&D expertise allow us to source and develop high potential assets emerging from China and the rest of the world, while continuing to expand our internally discovered global pipeline. We're also leveraging AI across the organization. For example, optimizing clinical trials, accelerating timelines, and sharpening our commercial analytics. These ongoing efforts are already improving our speed precision, and efficiency. Going forward, we will apply more AI tools to accelerate our future growth. We remain disciplined in our operations, scaling efficiently while investing strategically in both commercial execution and pipeline innovation. The progress we have made this quarter reinforces our conviction. Jean Wood's satellite is becoming a profitable, high-growth company with global impact, powered by innovation, disciplined execution, and a deep commitment to delivering long-term values for patients and shareholders alike. Now I turn the call over to Josh. Josh?

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