Iovance Biotherapeutics, Inc.

Welcome to the Iovance Biotherapeutics third quarter and year-to-date 2022 financial results and corporate updates conference call. My name is Andrew, and I'll 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 11 on your touchtone phone. 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 Vogt, our Interim President and Chief Executive Officer, Dr. Igor Belinsky, our Chief Operating Officer, Jim Ziegler, our Executive Vice President, Commercials. Dr. Frederick Zinkenstein, Chief Medical Officer. And John Mark Bellamy, our Chief Financial Officer. Dr. Madan Jagazia, our Executive Vice President, Medical Affairs. And Dr. Raj Puri, our Executive Vice President, Regulatory Strategy and Translational Medicine, are available for the Q&A session. This afternoon, we issued a press release that can be found on our corporate website at Iovance.com, which includes the financial results for the three and nine months ended on September 30, 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 plan, 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 SEC filing. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking data. With that, I will turn the call over to Fred.

Thank you, Sarah, and good afternoon, everyone. I am pleased to highlight some great momentum at iAdvance. We're getting ready to complete our Biologics License Application, or BLA, submission for our lead pill therapies, Lifolucil and Advanced Melanoma, while preparing for commercialization, developing our robust immuno-oncology pipeline. I'll begin today's introduction with a brief status update on the rolling BLA for Lifolucil, which we initiated in August. This remains our number one priority on behalf of our patients with Advanced Melanoma who are eager to see Lifolucil approved as soon as possible. A rolling BLA allows us to submit portions of the BLA to the FDA on an ongoing basis, so that the FDA may begin review as early as possible as documents are received, potentially allowing for earlier approval. We have continued to meet the submission schedule that we predetermined with the FDA and remain on track to complete the VLA submission this quarter. As a reminder, we previously received positive feedback from the FDA on the potency assay matrix. We also held a successful pre-VLA meeting in July where the FDA provided favorable feedback on clinical efficacy data from cohorts two and four, of our C14401 clinical trial, including duration of follow-up, and agreed that the clinical and safety data set was sufficient for a BLA review. The FDA remains engaged and supportive as we progress through the BLA submission process, and we look forward to continuing this level of collaboration. Bladpilucel, if approved, may address a significant unmet medical need for melanoma patients who progress on or after anti-PD-1 therapy, for which there are no FDA-approved treatment options. In addition, we are excited about the broader potential for lifeloosal as an earlier treatment for melanoma. We remain on track to begin a phase three trial of lifeloosal in combination with pembrolizumab and frontline advanced melanoma in late 2022, which is also designed to serve as a confirmatory study for our initial BLA submission. In anticipation of potential approval and launch of lifeloosal next year, our commercial readiness activities include medical education, treatment center onboarding, payer engagement, commercial manufacturing readiness, and near and long-term capacity planning. As part of our cross-functional effort to educate physicians about our clinical data and the unmet medical need in advanced melanoma, we are especially excited about the upcoming Society for Immunotherapy of Cancer, or CITC, annual meeting next week. We will present the detailed data from our C14401 trial cohorts 2 and 4 for the first time to the medical community in a rapid oral presentation at 1233 p.m. Eastern on November 10th. Earlier today, CITC issued a press release to announce the titles for the annual meeting press program. Our C14401 abstract was one of only eight abstracts selected out of more than 1,400 total abstracts to be part of the press conference. Following the presentation on November 10th, we will host an investor webcast and conference call with key opinion leaders, which will be accessible on our website. We look forward to having a high level of visibility at the meeting and encourage everybody on the call today to attend CITC and or participate in our investor event. In addition to the Lifolucel and melanoma, a growing TIL therapy pipeline has the potential to create significant value for cancer patients as well as our shareholders. We are treating patients in six Iovance clinical trials across multiple TIL treatment regimens and thalathemers, which Frederick will highlight on today's call. The strength of talent within Iovance also reflects tremendous enthusiasm for our TIL therapies and our global leadership within the field. We currently have more than 450 employees with deep expertise and successful track records in oncology, cell and gene therapy development and commercialization. I look forward to addressing your questions later during this call and will now ask Igor to address manufacturing updates.