Iovance Biotherapeutics, Inc.

Welcome to the Iovance Biotherapeutics First Quarter 2022 Financial Results. 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'll conduct a question-and-answer session. During the question-and-answer session, if you have a question, please press star, then 1 on your touch-tone phone. Please note that this conference is being recorded. I will now turn the call over to Sarah Pellegrino, Vice President, Investor, and Public Relations 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 Boat, our Interim President and Chief Executive Officer, Dr. Igor Balinski, our Chief Operating Officer, Jim Ziegler, our Senior Vice President Commercial, Dr. Frederick Zinkenstein, our Chief Medical Officer, Dr. Madan Jagazia, our Senior Vice President, Medical Affairs, and John Mark Bellamine, our Chief Financial Officer. Dr. Raj Puri, our Executive Vice President, Regulatory Strategy and Translational Medicine, is also on the call to participate in the question and answer session. This afternoon, we issued a press release that can be found on our website at iovance.com, which includes the financial results for the three months ended on March 31, 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 regulatory plans and results, research and pre-clinical activities, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interaction, collaboration, 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 our positive start to the year at Iovance during today's conference call. First and foremost, we are moving rapidly towards our first-ever BLA submission for our lead pill therapy, lifelucel, and metastatic melanoma. This is our top priority at Iovance. As we announced last month, we received positive feedback from the FDA regarding our potency assays and assay matrix for lifelucel. For next steps, we intend to hold a pre-BLA meeting in July 2022 and submit the BLA in August 2022. In addition, we continue discussions with the FDA about our registrational strategies in cervical cancer and non-small cell lung cancer so that we may offer TIL therapy to patients with significant unmet need in these additional tumor types. As we prepare to launch Leifelucel, we are also making progress in our commercial readiness and internal manufacturing capabilities at the Iovance Cell Therapy Center or ICTC, in Philadelphia. Our organization is growing to further our mission of innovating, developing, and delivering pill therapies. We now have nearly 400 employees at the company who have, on average, more than four years of cell therapy experience. The talent within our organization is a testament to the potential of our Iovance pill therapy and our global leadership within the field. We're excited about the momentum for our glowing pill pipeline. We continue to enroll patients across four Iovance-sponsored clinical trials, and plan to initiate two additional trials this year. The FDA has allowed an IND to proceed for a clinical trial of our PD-1 inactivated gene-edited TIL therapy, IV4001. We also plan to conduct a Phase III trial of TIL in combination with pembrolizumab and frontline melanoma, where clinical data demonstrated the potential to improve patient outcomes compared to pembrolizumab alone in patients who are naive to immune checkpoint inhibitors. As we prepare to launch the first one-time cell therapy in solid tumors, we believe that our TIL platform, clinical data, and people set a strong foundation to establish iAdvanced TIL therapy as the next class of paradigm-shifting therapies for people with cancer. Manufacturing and managing demand for a new cell therapy is key to our success. So I'll ask Igor to talk more about our progress in these areas.