Iovance Biotherapeutics, Inc.

Welcome to the Iovance Biotherapeutics third quarter and year-to-date 2023 financial results and corporate updates conference call. My name is Abigail, and I will 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. To ask a question, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. Please note that this conference is being recorded. I will now turn the call over to Sarah Pellegrino, Senior Vice President, Investor Relations and Corporate Communications at Iovance. Sarah, you may begin.

Thank you, operator. Good afternoon, and thank you for joining us. Speaking of today's call, we have Dr. Fred Voth, our Interim President and Chief Executive Officer, Dr. Igor Belinsky, our Chief Operating Officer, Jim Ziegler, Executive Vice President, Commercial, Dr. Frederick Finkenstein, our Chief Medical Officer, and John Mark Bellaman, 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 nine months ended on September 30th, 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 IOMAS'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 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 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'm pleased to highlight several recent important milestones for I-Advance. We continue to make significant progress towards U.S. commercialization while pursuing opportunities for our TIL therapies and additional geographies in solid tumor cancers. Our top priority is to secure FDA approval and launch like Volusil in the U.S., the new class of treatment for advanced melanoma patients with limited options. Overall, the BLA process continues under priority review with several positive status updates. We remain engaged with the FDA to complete the review as efficiently as possible. As a reminder, the FDA reiterated in September that there are no major review issues and no plans to hold an advisory committee meeting. In addition, all pre-approval inspections of all clinical sites and internal and external manufacturing and testing facilities have been successfully completed. The FDA is also engaged and has no concerns with the status of the Tobance 301 confirmatory trial which remains on track to be well underway by the PDUFA data. We appreciate the FDA review team's efforts to expedite the remaining review. We are confident in the potential for Lifolucel to redefine the treatment paradigm for these patients who have no approved options after current standard of care. With the strength of our clinical data, manufacturing capabilities, and commercial readiness efforts, IVAN is ready to rapidly serve the U.S. melanoma community immediately following approval, including the potential scenario for approval earlier than the February 24, 2024 PDUFA Beyond the US, we plan to submit additional marketing applications for Lake Volusia in Europe and other geographies. Based on positive feedback from the European Medicines Agency on codes two and four of the C14401 clinical trial, we plan to submit a marketing authorization application in the first half of 2024, with a potential European launch in 2025. We're also engaged with regulatory authorities in the United Kingdom and Canada. We plan to submit marketing applications in both countries in the second half of next year, again with potential launches in 2025. Key markets such as Germany, France, and the UK have mechanisms for early access and reimbursement that can begin to drive significant additional near-term revenue by the end of 2025. Next year, we expect to have additional regulatory updates about our expansion plans for life-reducing Australia and other countries with a significant number of advanced melanoma patients. Collectively, the advanced melanoma population in Germany, France, the UK, and Canada is slightly larger than the US patient population, with the same unmet medical need. Our geographic expansion, when complete, can more than double the total addressable patient population for Lefluso and advanced melanoma. We plan to leverage existing resources to serve the melanoma community in these new geographies without incurring significant additional expenses. For example, our IVAN Cell Therapy Center, or ICTC, has sufficient capacity for these new countries, and we already have an existing office in Amsterdam and field medical support in the region. As we prepare to launch Lifolucyl, we are also integrating Prolucan, a currently marketed IL-2 product used as part of the Tilt Therapy regimen. By owning Prolucan, we can offer it alongside Lifolucyl and have full control of the IL-2 supply chain. We also expect to lower clinical trial expenses and future cost of goods for Lifolucyl. Beyond our regulatory and commercial readiness activities, our robust Tilt Therapy pipeline continues to advance with seven active clinical trials. These include two registrational trials, IVANCE and frontline melanoma, and LUN202 in previously treated advanced lung cancer, which Frederick will highlight in a moment. Completing enrollment in LUN202 in 2024 is a top priority towards a potential supplemental VLA filing. Additional clinical trials include the IOV COM202 trial in solid tumors, and our first in-human trial of our genetically modified TIL therapy, IOV4001. Lastly, we are excited to introduce a new I-Advanced TIL therapy program in endometrial cancer. Checkpoint inhibitors are moving into earlier lines of therapy, leaving an unmet medical need for patients who request on or after immunotherapy and chemotherapy. Frederick will provide more details on this new program later in this call. Turning to our organization, we have more than 500 people with experience in developing and commercializing oncology and cell and gene therapy products. They are ready for our initial US launch, ex-US expansion, and ongoing pipeline developments. We have recently completed headcount growth and significant one-time investments in commercial manufacturing readiness activities. to prepare for launch and expand our pipeline. Following these one-time investments in strategic portfolio prioritization, we can reduce quarterly and annual operating expenses in the remainder of 2023 and full year 2024, while continuing all key clinical programs and internal manufacturing capabilities. In addition, our September 30th cash position of roughly $428 million is expected to fund our operating plan into 2025. John Mark will provide additional color on the expense guidance and cash runaway assumptions on today's call. We're excited about the near-term future at IVANS as we advance and broaden our mission to be the global leader in innovating, developing, and delivering tilt therapies for people with cancer across multiple cell tumors. I look forward to addressing your questions later in this call, and will now ask Igor to present our manufacturing updates.