Iovance Biotherapeutics, Inc.

Welcome to the Iovance Biotherapeutics fourth quarter and full year 2022 financial results and corporate updates conference call. My name is Gigi 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. 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 Commercial, Dr. Frederick Finkenstein, our Chief Medical Officer, and John Mark Belleming, our Chief Financial Officer. Dr. Raj Puri, our Executive Vice President, Regulatory Strategy and Translational Medicine, is also 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 12 months ended on December 31st, 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 and transactions, pre-commercial activities, clinical trials and results, regulatory interactions, plans and strategies, research and pre-clinical 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 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, and good afternoon, everyone. I am pleased to highlight the positive milestones and significant progress that I advanced in 2022 and into the beginning of 2023. We are close to completing our biologics license application, or BLA, for our lead TIL therapy, lifelucel, and advanced melanoma before the end of this quarter. We are also preparing for commercialization, developing our robust immunology pipeline and integrating Prolucan upon the close of our planned acquisition. The BLA for Lefalucil remains our number one priority on behalf of patients with advanced melanoma who progress on or after anti-PD-1 therapy. This represents a significant unmet medical need given that there are currently no FDA-approved treatment options in this setting. I feel very confident going into the BLA review process given the strength of our clinical data and unmet need as well as several positive interactions with and feedback from the FDA during 2022. These included FDA alignment on the potency assay matrix last April and a successful pre-BLA meeting in July where the FDA provided favorable feedback on the clinical efficacy data from cohorts two and four of our C14401 clinical trial, including duration of follow-up and that the clinical and safety data set was sufficient for a BLA review. In the fourth quarter, we also reached agreement with the FDA on our recently started Tilvance 301 phase three trial, frontline advanced melanoma, to serve as a registrational trial on that indication, as well as a confirmatory study supporting full approval of lifelucel in post-anti-PD-1 advanced melanoma. We expect TILVANS 301 to be well underway at the time of potential approval, and Frederick will talk about additional details of the trial on today's call. Overall, the FDA continues to be engaged and supportive. We look forward to continuing this level of collaboration in 2023. We're also preparing to integrate Prolucan upon the close of our planned acquisition of this product. As a reminder, we announced last month that we have entered into a strategic transaction with Clinogen to acquire worldwide rights to Prolucan, an IL-2 product with currently approved indications that is importantly also used to promote T cell activity following TIL infusions. We have a strong strategic fit and rationale for this transaction, which provides immediate and future revenue and full control of the IL-2 supply chain and logistics surrounding TIL therapy. and is expected to lower clinical trial expenses and future cost of goods for Lifolucel. In addition to Lifolucel and melanoma, we are building a deep and diverse till therapy pipeline in multiple solid tumor types that has the potential to create significant value for cancer patients as well as our shareholders. We are conducting six active clinical trials, preparing the randomized patients in the frontline melanoma treatment setting in our first phase three study, and advancing several genetically modified TIL therapies, which Frederick will also highlight on today's call. As we grow our organization to prepare for our first potential launch, we currently have more than 500 iAdvance employees who have expertise in developing and commercializing oncology and cell and gene therapy products. I look forward to addressing your questions later during this call and will now ask Igor to address our manufacturing updates and preparations to supply commercial TIL therapies upon potential approval. Thank you, Fred.