Iovance Biotherapeutics, Inc.

Welcome to the Iowa Vance Biotherapeutics second quarter and first half 2022 financial results and corporate updates conference call. My name is Andrew and I will be your operator for today's call. At this time, all participants are in a listen only mode. Later, we will conduct a question and answer session. During the question and answer session, if you have a question, please press star 1 1 on your telephone. 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 at Iovance. Sarah, you may begin.

Thank you, operator. Good afternoon, and thank you for joining us. Speaking on today's call, we have Dr. Fred Voth, our Interim President and Chief Executive Officer, Dr. Igor Belinsky, our Chief Operating Officer, Jim Ziegler, our Executive Vice President Commercial, Dr. Frederick Finkenstein, our Chief Medical Officer, and Jean-Marc Bellemain, our Chief Financial Officer. Dr. Madan Jagadia, our Executive Vice President, Medical Affairs, and Dr. Raj Puri, our Executive Vice President, Regulatory Strategy and Translational Medicine, are also available for the Q&A session. This afternoon, we issued a press release that can be found on our corporate website at iovant.com which includes the financial results for the three and six months ended on June 30th, 2022, as well as recent corporate updates. 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, pre-commercial activities, clinical trials and results, regulatory 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 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 the call over to Fred.

Thank you, Sarah. Good afternoon, everyone. I am pleased to highlight our significant year-to-date progress at IVAS. I'll begin with our first planned biologics license application, or BLA, for our lead till therapy, lipolucel, and metastatic melanoma. This is our number one priority on behalf of patients who are eager to see life-reducible approvals. We successfully completed a pre-BLA meeting with the FDA in July, and we are on track to begin the BLA submission this month. The FDA provided favorable feedback on the clinical efficacy data from cohorts two and four of the C14401 clinical trial, including duration of follow-up, and the post-CSA matrix. The FDA also agreed to the clinical and safety data that was sufficient for a VLA review and provided valuable feedback and advice regarding various parts of the planned VLA submission. Following the pre-VLA meeting, we will commence the rolling VLA submission this month. The rolling VLA submission is a benefit available under our Regenerative Medicine Advanced Therapy, or RMAT, designation. A rolling VLA allows us to submit sections of the VLA to the FDA on an ongoing basis. This process enables the FDA to begin review of submission documents as early as possible as they are received, potentially allowing for earlier approval. We expect to complete the rolling BLA submission during the fourth quarter of this year. We are pleased with the outcome of the pre-BLA meeting, which multiple members of FDA's senior management team attended. The FDA is engaged and supportive of the BLA for life of Lucille, and we look forward to continuing this level of collaboration throughout the submission and review process. In parallel with the BLA-related activities, we're actively preparing to launch Lake Volusil. Key pre-commercial activities including medical education, treatment center onboarding, payer engagement, commercial manufacturing readiness, and near and long-term capacity planning. We aim to successfully deliver TIL therapy to cancer patients and create value for our shareholders. We're also excited about the advancement of our TIL cell therapy pipeline. We're recruiting patients across five I-Advanced clinical trials including the recently initiated trial of our first genetically modified pill therapy. Six cohorts of non-small cell lung cancer patients are part of three of these active trials, reflecting our focus on that indication. We are also on track to initiate a phase three trial of lifeloosal in combination with pembrolizumab and frontline melanoma towards the end of the year. As noted in this afternoon's press release, we are expecting our C14501, sorry, C14504 study to support a BLA submission for liposomal and cervical cancer, which Frederick will highlight further. This updated registration strategy reflects FDA discussions and feedback that address the shift in frontline standard of care in cervical cancer. As we prepare to launch the first one-time cell therapy for solid tumors, we are growing the organization to advance our mission of innovating, developing, and delivering pill therapies. Today, we have nearly 450 employees that bring deep expertise and successful track work as oncology and cell therapy development and commercialization. The strength within our organization reflects tremendous enthusiasm for our IVAN TIL therapies and our global leadership within the field. I look forward to addressing your questions later during this call. We'll now ask Igor to discuss manufacturing updates.