Iovance Biotherapeutics, Inc.

Welcome to the Iovance biotherapeutics conference call to discuss the full year 2023 results and recent corporate updates. My name is Kevin and I'll be your operator for today's call. At this time, all participants are on a listen-only mode. Later, we will conduct a question and answer session. Please note that this conference is being recorded. I will now turn the call over to Sarah Pellegrino, Senior Vice President, Investor Relations and Corporate Communications, Iovance. Sarah, you may begin.

Thank you, Operator. Good afternoon, and thank you for joining our conference call and webcast to discuss full year 2023 results and recent corporate updates. Dr. Fred Vogt, our Interim President and Chief Executive Officer, will provide a brief introduction. Jim Ziegler, EVP Commercial, will highlight our initial insights for the U.S. commercial launch of Amtagvi following the recent U.S. Food and Drug Administration, or FDA, approval in advanced melanoma, Igor Balinski, Chief Operating Officer, will highlight commercial manufacturing and capacity expansion plans. Frederick Graf Finkenstein, our Chief Medical Officer, will summarize key clinical pipeline highlights. And John Mark Belleming, Chief Financial Officer, will review our financial results. Dr. Brian Gassman, EVP Medical Affairs, and Raj Puri, EVP Regulatory Strategy and Translational Medicine, are also on the call and available for the Q&A session. Before we start, I would like to remind everyone that statements made during this 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 interactions, 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 SEC filing. 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 the call over to Fred.

Thank you, Sarah, and good afternoon, everyone. I'm pleased to host our 2023 full-year results conference call. Throughout last year, we executed toward our first approval of commercial lawns while advancing our pipeline. On today's call, we have a variety of exciting topics to cover on the heels of the US FDA's recent approval of Abtagme, the first one-time T-cell therapy for a cell tumor. Antagni's label allows it to become the first treatment option for advanced melanoma patients after anti-PD-1 and targeted therapy. The strength of this label also reflects a best-case scenario with strong efficacy data from pivotal cohort four as well as pooled cohorts two and four. In the first few days of U.S. launch, we were seeing strong demand and momentum for Antagni. Consequently, we also expect increased demand for Prolucan. Thirty authorized treatment centers, or ATCs, were ready for approval, and nearly all have identified a patient. Jim will provide more detail later in the call. The first tumor resection occurred on the first business day after approval, and commercial manufacturing began the following day at our IVAN Cell Therapy Center, or ICPC. This is a testament to the high unmet medical need and the great excitement around this new therapy, as well as our commercial manufacturing readiness. Igor will talk today about our capacity to serve our near-term commercial launch clinical trials and ongoing expansion plans. In addition to the U.S. launch, our near-term expansion plans for AMTAGV are focused on addressing many thousands of additional patients by entering new geographies and broadening the label to include frontline advanced melanoma as well as other indications. For example, our planning global expansion has the potential to double the total number of addressable patients for AMTAGV and post-anti-PD-1 melanoma. We remain on track to submit regulatory dossiers this year in the European Union in the first half of the year, followed by the United Kingdom and Canada in the second half. In addition, our Phase III TILVAS-301 trial continues with strong momentum in several countries to support regulatory submissions and frontline advanced melanoma. We are also pleased with the progress with our robust development pipeline across solid tumor cancers. Frederick will speak later about some key highlights in our ongoing clinical trial programs. Today, Iovane is a fully integrated company and is now the first company to commercialize the T cell therapy for solid tumor indications. We are well positioned to execute on our regulatory pipeline manufacturing commercial launch activities to remain the global leader in TIL cell therapy. Jim will now describe the ongoing activities related to our U.S. launch.