Iovance Biotherapeutics, Inc.

Welcome to the Iowa Vance Biotherapeutics third quarter and year-to-date 2021 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 touchtone telephone. Please note that today's 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 Balinski, our Chief Operating Officer, Jim Ziegler, our Senior Vice President Commercials, Dr. Frederick Sinkenstein, our Chief Medical Officer, and Jean-Marc Bellemin, our Chief Financial Officer. Dr. Madan Jagazia, our Senior Vice President, Medical Affairs, and Laurel Todd, Vice President of Policy, are also on the call to participate in the Q&A 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 nine months ended on September 30th, 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 filing. 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 year-to-date progress that I have answered in today's conference call. We have continued to advance our tumor-infiltrating lymphocyte, or TIL, platform into new indications and earlier treatment settings throughout this year. For our lead TIL product candidate, lifelucel and metastatic melanoma, our top priority remains our ongoing work to address FDA feedback regarding the potency assays for lifelucel to support our planned VLA submission. We have continued ongoing work developing and validating our potency assays and have engaged in discussions with FDA during the second half of 2021. The anticipated BLA submission for lifelucel continues to be planned for the first half of 2022. We remain confident in our current guidance and timelines. Resolution of the potency assays for lifelucel is also an important next regulatory step for our cervical and non-small cell lung clinical programs. Turning to our clinical pipeline, we now have clinical data showing the promise of TIL therapy in four different solid tumor types, from first line to late-stage treatment settings, furthering our confidence in TIL as a broad platform that may shift the treatment paradigm for patients with cancer. We continue to be excited about three key initiatives that have the potential to meaningfully impact patients while creating shareholder value. First, lifeloosal and post-anti-PD-1 melanoma continues to show increasing long-term durability following one-time treatment. as demonstrated in our ASCO 2021 presentation, where we showed median duration of response was not reached at 33 months of median study follow-up. Second, we continue to build on the potential for the combination of TIL with pembrolizumab, which supports our strategy to broaden access to TIL therapy for more patients in earlier treatment settings. We're excited about presenting combination data in several advanced cancers at the upcoming CITC annual meeting. As noted in this afternoon's press release, The FDA granted fast-track designation for lifeloosal in combination with pamerilizumab for the treatment of metastatic melanoma based on the unmet medical need and potential advantages for this combination over available care. This fast-track designation allows for potential accelerated approval and priority review as well as more frequent interactions with FDA. Finally, our initial clinical data in metastatic non-small cell lung cancer demonstrated a 21.4% overall response rate in heavily pretreated patients, all of whom have progressed prior immune checkpoint inhibitor therapy. This population represents a significant unmet need in non-small cell lung cancer. We provided a top-line corporate announcement of the initial data earlier in the second quarter and look forward to presenting these data to a physician audience for the first time during the upcoming CITSE meeting. On the research side, we are bringing the next generation of toll products and supporting therapies into the clinic. We are advancing a TIL product that is genetically modified to inactivate PD-1, which we have designated IOV-4001, as well as our novel IL-2 analog, IOV-3001. Both IOV-4001 and 3001 are progressing through IND-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 patients with cancer and multiple solid tumor cancers in treatment settings. I'm confident in the quality of our senior leadership as well as our full internal organization to deliver towards this mission. Today, we have more than 300 employees who on average have more than three and a half years of cell therapy experience. Members of our executive leadership team will now provide updates for their respective departments, beginning with our Chief Operating Officer, Igor Belinsky. Igor Belinsky Thank you, Fred.