Iovance Biotherapeutics, Inc.

Welcome to the Iovance biotherapeutics conference call to discuss first quarter 2024 results and recent corporate updates. My name is Livia and I'll be your operator for today's call. At this time, all participants are in listen-only mode. Later, we will conduct a question and answer session. Please note that this conference is being recorded. I will now hand the conference call over to Sarah Pellegrino, Senior Vice President, Best Relations and Corporate Communications at Iovance. Sarah, you may begin.

Thank you, Operator. Good afternoon, and thank you for joining this conference call and webcast to discuss our first quarter 2024 results and recent corporate updates. Dr. Fred Vogt, our Interim President and Chief Executive Officer, will provide an introduction and summarize key updates on our U.S. commercial launch event and TAGV and our pipeline program. Jim Ziegler, EVP Commercial, will highlight our initial success with the U.S. commercial launch of mTAGV in advanced melanoma. Dr. Igor Walensky, COO, will comment on our commercial manufacturing experience and capacity expansion plans. Jean-Marc Fellemane, CFO, will review our financial results. And Dr. Frederick Finckenstein, Chief Medical Officer, will review key pipeline updates, including upcoming clinical data presentations at ASCO, and new next-generation approaches. Dr. Brian Gaspin, Executive Vice President, Medical Affairs, and Dr. Raj Puri, Executive Vice President, Regulatory Affairs, are also on the call and available for the Q&A session. Earlier this afternoon, we issued a press release that can be found on our corporate website at iovance.com. Before we start, I would like to remind everyone that statements made during this conference call will include forward-looking statements regarding IOVANCE's goals, business focus, business plans and transactions, revenue, commercial activities, clinical trials and results, regulatory approvals and interactions, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interaction, licenses and collaborations, cash position and expense guidance, and future updates. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our FTC filings. Our results may differ materially from those projected during today's call. we undertake no obligation to publicly update any forward-looking statements. With that, I will turn it over to Fred.

Thank you, Sarah, and good afternoon, everyone. I am pleased to host our first quarter of 2024 results conference call. This has been a decisive year for Iovance following our first FDA approval and a strong start to the U.S. launch of Antagni for patients with advanced melanoma. We expect the positive momentum at Iovans will continue to build throughout 2024 as we ramp up the U.S. launch and execute across our broad clinical pipeline. To begin, we are very pleased that the high initial demand for Ampagni continues to accelerate. Demand has increased month over month since approval and expected to grow further throughout the year. As of today, more than 100 patients are already enrolled for Ampagni therapy, and most are expected to be ready for infusion across the second and early third quarters of 2024. In addition, more than 60 additional patients have been identified as ATCs and are expected to enroll soon. As existing and new ATCs continue to build experience, we expect patient enrollments to steadily increase throughout the year, supporting our expectations for sustained growth. As we anticipated, interest is very high at our ATCs, and they are demonstrating that they have the training, infrastructure, and capabilities to treat patients with antagony, which Jim will further highlight. We remain on track to have 50 total ATCs by the end of this month. We also set a new goal of at least 70 ATCs by the end of this year, representing the largest ever number of ATCs for a cell therapy launch. We are pleased to see positive reimbursement trends, which is a key indicator for success in adoption. Positive reimbursement decisions are supported by our clinical data, and the recent addition of Antacne is the preferred second line for subsequent therapy in the National Comprehensive Cancer Network, or NCCN, guidelines. Time to treatment will accelerate as ATCs establish a solid foundation for broad market access and reimbursement, which will add to momentum. Jim will describe this in more detail. In terms of commercial manufacturing, we have two FDA-approved manufacturing sites in sufficient capacity to meet near-term demand and launch, setting a new bar for cell therapy launches. Our commercial manufacturing experience is very positive and is consistent with our prior clinical experience. We have successfully manufactured and delivered an antagonist within our target turnaround time of 34 days. ATCs have observed sufficient availability of manufacturing slots and report a positive experience in the scheduling process, which is critical for broader utilization. We expect to have ample capacity to meet the anticipated ramp-up in demand this year. Finally, long-term expansion is already underway to more than double our currently built capacity for future growth. In addition to the U.S. launch, we are working to enter new markets that can more than double the total addressable advanced melanoma patient population for FTAG-B. Regulatory submissions remain on track this year in the EU, UK, and Canada, where we have the potential to begin driving significant additional revenue by the end of 2025. We also continue to advance and expand our robust and exciting pipeline, including two registrational programs, as well as new next-generation approaches that Frederick will highlight on this call. As a fully integrated company that's executing a U.S. launch and developing a broad pipeline, IVANZ is well positioned to remain the global leader in innovating, developing, and delivering pill cell therapy for patients with cancer. I'll now hand it over to Jim, our Executive Vice President of Commercial, who will speak in more detail about our launch metrics.