Iovance Biotherapeutics, Inc.

Welcome to the Iowa Vance Biotherapeutics Second Quarter 2023 Financial Results and Corporate Updates Conference Call. My name is Shannon, 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. Please note that this conference is being recorded. I will now turn the call over to Sarah Pellegrino, Senior Vice President, Investor Relations Corporate Communications at Iowa Vance. 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 Executive Vice President Commercial, Dr. Friedrich Frankenstein, our Chief Medical Officer, and John Mark Bellemane, our Chief Financial Officer, Dr. Brian Gassman, Executive Vice President, Medical Affairs, and Dr. Raj Puri, our Executive Vice President, Regulatory Strategy and Translational Medicine, are 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 and six months ended on June 30, 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, revenue, pre-commercial activities, clinical trials and results, regulatory interactions, plans and strategies, research and pre-clinical 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, I will turn the call over to Fred.

Thank you, Sarah, and good afternoon, everyone. I am pleased to highlight several important milestones for IVANs during the second quarter of 2023 and more recently. Our biologics license application, or BLA, for our lead tiltherapy, Lifilucil, and advanced melanoma was accepted by the U.S. Food and Drug Administration, or FDA, for six-month priority review and granted a PDUFA date of November 25th, 2023. In the acceptance letter, the FDA also informed us that they do not intend to host an advisory committee meeting and that no major review issues were identified. Lifolucil, if approved, would be the first cell therapy for treatment of melanoma in addition to the first individualized one-time T-cell therapy for solid tumor cancer. During the priority review process, we have continued to collaborate with the FDA as they review this new class of treatment for advanced melanoma patients with limited options. We remain confident in our prospects for approval, given the unmet medical need, our strong clinical data, and our positive interactions with and feedback from the FDA. As we approach our PRDUCA date, we're building capacity and staffing our I-Advanced Cell Therapy Center, or ICTC, to supply our projected demand for Elefalucil at launch. In addition, our field teams are proceeding as planned with onboarding and site readiness activities for our Authorized Treatment Centers, or ATCs, to treat the first lifelucel patient as soon as possible upon approval. I would also like to highlight that we are now a commercial stage company after closing our transaction to acquire Prolucan, an IL-2 product used as part of the TIL therapy regimen in May. We are integrating Prolucan into our organization as we prepare to launch lifelucel so that we can offer two important parts of the TIL regimen. As noted in today's press release, we recognize some revenue for the first time from Prolucan sales and expect to realize more significant revenue with the launch of lifelucel. Owning Perlucan also provides us with full control of the IL-2 supply chain and logistics surrounding TIL therapy, and we expect lower clinical trial expenses and future costs of goods for Lifolucel. Beyond our regulatory and commercial readiness activities for Lifolucel, our robust TIL therapy pipeline includes seven active clinical trials with the potential to strengthen and broaden our mission to be the global leader in innovating, developing, and delivering TIL therapies for people with cancer across multiple solid tumors. In frontline melanoma, our confirmatory trial, TILVANS301, has begun randomizing patients and remains poised to be well underway upon a potential approval of lifelucel later this year. We have also made significant progress across our trials in non-smell cell lung cancer, NSCLC. We recently announced positive clinical and regulatory updates related to IVLUN202, our registrational single-arm phase two trial in post-anti-PD1 lung cancer. At the upcoming World Congress on Lung Cancer, or WCLC, in Singapore, we look forward to presenting detailed data from cohort 3A of our IOV-CONN202 trial in anti-PD-1 naive lung cancer. The cohort 3A data supports our strategy in upcoming trial in frontline lung cancer. This trial in frontline lung cancer can also potentially serve as a confirmatory trial to support an accelerated approval base on the IOV-LUN202 trial. As we prepare to launch Leifelucel, Iovance now has almost 600 employees with experience in developing, 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.