Iovance Biotherapeutics, Inc.

Hello, and thank you for standing by. My name is Andrew, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Iovance Biotherapeutics first quarter 2023 financial results conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star then one on your telephone keypad. If you'd like to withdraw your question, press star one again. It is now my pleasure to introduce Senior Vice President, Investor Relations and Corporate Communications, Sarah Pellegrino.

Thank you, Operator. Good afternoon, and thank you for joining us. Speaking on today's call, we have Dr. Fred Vose, 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 Bellamine, our Chief Financial Officer. Dr. Raj Puri, our Executive Vice President, Regulatory Strategy and Translational Medicine, is 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 months ended on March 31st, 2023, 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 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 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 introduction, I will turn the call over to Fred.

Thank you, Sarah. Good afternoon, everyone. I'm pleased to update you on a productive start to the year at I-Advance in 2023. We successfully completed our biologics license application, or BLA, for our lead TIL therapy, lifelucel, and advanced melanoma at the end of the first quarter. This represents a critical step forward in our journey to deliver the first individualized one-time T cell therapy for a solid tumor. I would like to acknowledge the patients and physicians who participated in the C14401 clinical trial and the FDA review team for their commitment and support, as well as our internal team for their tremendous effort in completing the first BLA submission for IVANS. We look forward to continued collaboration with the FDA as they review this new class of treatment for advanced melanoma patients with limited options. In terms of next steps, the FDA has 60 days from when we completed the submission to determine the acceptability of the BLA for review, which is approximately May 26. We will provide an update as soon as we can. If accepted for a six-month priority review, that would result in a decision on approval by late November. We feel confident going into the BLA review process, given the unmet medical need and strength of our clinical data, as well as several positive interactions with and feedback from the FDA. As we prepare for potential commercialization, we are also developing our robust immuno-oncology pipeline and plan to execute an integration plan for Prolucan. Earlier this year, we entered into a strategic transaction with Clinigen to acquire the worldwide rights to Prolucan, an IL-2 product with currently approved indications that is importantly also used to promote T-cell activity following TIL infusion. We expect Perlucan to provide revenue and full control of the IL-2 supply chain and logistics surrounding TIL therapy, as well as a reduction in both clinical trial expenses and future cost of goods for Lifolucel. We expect to close this transaction imminently, and we will file our Form 10-Q tomorrow afternoon with more information. In addition, our robust TIL therapy pipeline includes seven active clinical trials in multiple solid tumor types with the potential to create significant value for cancer patients and shareholders. As we grow our organization to transition to a commercial company, we currently have more than 500 iAdvance employees experienced 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 present our manufacturing updates.