Iovance Biotherapeutics, Inc.

Welcome to the Iovance Biotherapeutics Fourth Quarter and Full Year 2021 Financial Results. My name is Cherie, 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 session, if you would like to ask a question, please press star then 1 on your touchtone 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 IOAN. 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 Senior Vice President, Commercial, Dr. Frederick Finkenstein, our Chief Medical Officer, and Jean-Marc Bellemin, our Chief Financial Officer. Dr. Madan Jagazia, our Senior Vice President, Medical Affairs, is also on the call to participate in the Q&A. This afternoon, we issued a press release that can be found on our website at iEvents.com which includes the financial results for the three and 12 months ended on December 31st, 2021, as well as 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 technology, manufacturing capabilities, regulatory feedback and guidance, payer interaction, collaboration, cash position, 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.

Thanks, Sarah, and good afternoon, everyone. I'm pleased to highlight our fourth quarter and full year of 2021 progress that I advanced during today's conference call. In 2021, we continued to advance toward our first BLA submission and expanded our TIL platform into new indications and earlier treatment settings. For our lead pill therapy, lifelucel, our top priority remains our planned BLA submission in metastatic melanoma. We have continued ongoing work developing and validating our potency assays. We have also engaged in discussions with the FDA during the second half of 2021, and we are confident in our current guidance for the anticipated BLA submission during the first half of 2022. Resolution of the potency assay in melanoma is also a key step towards regulatory plans and other indications. 2021 was our busiest year yet in terms of TIL data presentations. Over the past 12 months, we presented data in 118 patients across five indications and four solid tumor types at multiple medical meetings, including the American Association for Cancer Research, or AACR, meeting, the American Society of Clinical Oncology, or ASCO, meeting, and the Society for Immunotherapy of Cancer, or CIPSI, meeting. We believe that this growing set of clinical data continue to demonstrate the power, the potential power of Iovance still therapy to become the next paradigm shifting treatment regimen for solid tumors. Last year, we also opened the Iovance Cell Therapy Center or ICTC in Philadelphia. We have made significant progress in our internal manufacturing capabilities at ICTC, which Igor will highlight further. And we grow our organization to prepare for commercial manufacturing and launch. Today we have approximately 350 employees at the company who have, on average, more than four years of cell therapy experience. We believe that the breadth and depth of talent within our organization during this important time of growth is a testament to the potential of our IV and still therapy in solid tumors and our ability to maintain leadership within the field. Looking towards 2022, our milestones include submitting our BLA for Leif Lussel and metastatic melanoma in the first half of the year, advancing TIL therapy in non-small cell lung cancer, which Frederick will highlight, executing an updated registration strategy in cervical cancer based on FDA dialogue and feedback in reflection of the evolving landscape of care in this indication, defining our strategy for TIL plus PEMBRO combinations in early-line solid tumors beginning with melanoma, and finally initiating the first I-Advanced Clinical Study for IOV4001, a genetically modified TIL product in which PD-1 is inactivated, and further advancing our research and next-generation TIL programs to remain at the forefront of TIL therapy in solid tumors. Overall, we are confident in the strength of IVANTS' position to be the global leader in developing, delivering, and innovating TIL therapies for patients with cancer. We are well on our way to becoming a fully integrated organization to launch the first one-time cell therapy in solid tumors. Owning our manufacturing capabilities is the key to our success, so I will hand the call to Igor now to talk more about our progress there.