Iovance Biotherapeutics, Inc.

Welcome to the Iovance Biotherapeutics second quarter 2021 financial results. My name is Josh, 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 question and answer session, if you have a question, please press star, then the one on your touchstone telephone. 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 Fred Vogt, our Interim President and Chief Executive Officer, Igor Belinsky, our Chief Operating Officer, Jim Ziegler, our Senior Vice President Commercial, Dr. Frederick Finkenstein, our Chief Medical Officer, and Jean-Marc Bellemeyne, our Chief Financial Officer. Dr. Madan Jagacia, our Senior Vice President of Medical Affairs, 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 and six months ended on June 30, 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, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interactions, 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'm pleased to highlight our progress in the second quarter and first half of 2021 at I-Advance during today's conference call. During this year, we have continued to advance our tumor infiltrating lymphocyte, or TIL, pipeline. We've reported clinical data across our metastatic melanoma program, including our first clinical data in early-line melanoma, as well as in new indications, such as metastatic non-small-cell lung cancer. For our lead TIL product candidate, life-loose-soul metastatic melanoma, Our top priority remains our ongoing work to address FDA feedback regarding the potency assays for lipoleucine to support our planned BLA submission. We are confident in our ability to address FDA feedback and complete our work on additional assays in a timely manner. We are engaged in an ongoing dialogue with the FDA that we plan to continue through the second half of the year to support a BLA submission in the first half of 2022 as guided. Resolution of the potency assays is also an important next step towards progress in our other late-stage clinical programs. Turning to our clinical pipeline updates, we now have clinical data showing the promise of TIL therapy in four different solid tumors pipes. Across various treatment settings, furthering our confidence in TIL as a broad platform and next class of cancer treatment. Frederick will summarize the key updates in a moment, but overall, we are really excited about three key takeaways. First, our initial data in metastatic non-small cell lung cancer demonstrated a 21.4% overall response rate in a heavily pre-treated patient population, all of whom have progressed on prior immune checkpoint inhibitor or ICI therapy, which represents a significant unmet need in the patient population in non-small cell lung cancer. Next, lipoleucine-imposed anti-PD-1 melanoma continues to show increasing long-term durability. And third, the initial results for lifolucelone combination with pembrolizumab showed an 86% overall response rate, including a 43% complete response rate in anti-P1 naive melanoma patients. And it supports our broader strategy to combine i-Advanced TIL with available therapies and move into earlier treatment settings in solid tumors. On the research side, we are bringing the next generation of TIL and supporting therapies into the clinic. As we noted in today's press release, we are advancing a pill that is genetically modified to knock out PD-1, which we have designated IOV-4001, as well as our novel IL-2 analog, IOV-3001. Both IOV-4001 and IOV-3001 are progressing through IMD-enabling studies and are moving towards the clinic. In summary, we continue to execute all development, manufacturing, and pre-commercial activities in furthering our commitment to address the critical needs of cancer patients. I am very confident in the quality of our senior leadership, as well as our whole internal organization, to deliver towards this mission. Today, we have more than 270 employees who, on average, have more than three and a half years of self-therapy experience. On the call today, I would like to ask the members of our executive leadership team to provide updates for their respective departments, beginning with our Chief Operating Officer, Igor Belinsky.