Iovance Biotherapeutics, Inc.

mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Sarah Pellegrino, Senior Vice President, Investor Relations, and Corporate Communications. Please go ahead.

Thank you, operator. Good afternoon, and thank you for joining the Iovance conference call and webcast to discuss our second quarter and first half 2025 financial results, as well as recent updates. Dr. Fred Vose, our interim chief executive officer and president, will provide an introduction and brief overview of our key financial results, including revenue and revenue guidance, operating expenses, and our strategic restructuring. Dan Kirby, Chief Commercial Officer, will discuss product revenue and commercial and regulatory updates for mTAGI. Dr. Igor Belinsky, our Chief Operating Officer, will provide a manufacturing update. And Dr. Frederick Finkenstein, our Chief Medical Officer, will summarize our priority pipeline program. Additional members of our leadership team, including Dr. Raj Puri, our Chief Regulatory Officer, and Dr. Brian Gassman, our Executive Vice President of Medical Affairs, will be available for the Q&A session. In addition, our new Chief Financial Officer, Coraline Roche, is joining today's call. Earlier this afternoon, we issued a press release that is available on our corporate website at iovance.com. 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 and revenue guidance, commercial activities, clinical trials and results, regulatory approvals and interactions, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interactions, restructuring plans and workforce reductions, 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 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 welcome to the I-Advanced second quarter and first half 2025 conference call. We are more than a year into our U.S. launch of Antagni for advanced melanoma, the first FDA-approved TIL cell therapy. Adoption continues to grow, and for the first time, we surpassed more than 100 patients treated in a single quarter. We're also excited about our first real-world data set for Antagni monotherapy in a commercial setting. Topline results showed a nearly 49% response rate among 41 patients, 23 patients treated in third-line or earlier treatment settings, and approximately 61% response rate, all from patients treated in accordance with their label. We look forward to sharing more detailed real-world data at an upcoming medical meeting. Another important growth driver for Ampagni is onboarding large community practices to join our ATC network. We plan to begin treating patients from these practices in the fourth quarter of this year. Patients in the community are generally earlier in their melanoma treatment journey, and we expect that the higher response rates observed in our real-world data set will also be relevant to these patients. Our commercial business is complemented by an exciting pipeline led by our programs to extend the Lifolucil franchise in the new treatment settings and solid tumor types, as well as next-generation approaches. We remain on track for multiple clinical milestones in the second half of this year, including updated data from our registrational trial of Lifolucil monotherapy, previously treated advanced non-small cell lung cancer, clinical data for lipoleucine monotherapy and endometrial cancer, and for IV4001, our next generation PD-1 inactivated till cell therapy. Today I will cover financial results at a high level, focusing on revenue, expenses, cash runway, and the expected cost savings from our strategic restructuring. I'll begin with revenue and gross margins. In the second quarter, we reported $60 million in total revenue, a 22% growth over the prior quarter of this year. Total revenue included approximately $54 million from tagging infusions and approximately $6 million from ProLuca. Based on current growth dynamics and with approximately $109 million in total revenue for the first half of 2025, we are reiterating our full year 2025 revenue guidance of $250 to $300 million, inclusive of sales from Ampagni in the U.S. and ProLucan globally. We contain a strong demand for Ampagni and the potential to achieve U.S. peak sales of $1 billion or more. There's also a significant opportunity to add to the revenue potential in the international markets. Gross margin was 31%, excluding non-cash items such as intangible amortization, stock-based compensation, and reserves primarily for excess ProLucan inventory. Our recent restructuring is expected to improve gross margins in the near term to reduce cost of sales. Gross margins are also expected to increase significantly through near-term optimization of manufacturing capacity utilization over the next several years. In summary, we're focused on improving our profitability and are pleased with the strong momentum from our U.S. commercial business. Transitioning to the second quarter of 2025 expenses. Total operating expenses were approximately $117 million, compared to approximately $102 million in the prior year period. This increase was primarily related to higher headcount and related costs, and costs for clinical trials and marketing and advertising support for AMTAGME, partially offset by reductions in stock-based compensation. After experiencing a tremendous period of organizational growth in 2023 and 2024, We are fully committed to streamlining expenses and optimizing business performance through a strategic restructuring announced today. This restructuring includes a workforce reduction of approximately 19% in the third quarter of 2025 and will generate more than $100 million in annual cost savings starting in the fourth quarter of 2025. As I mentioned earlier, in addition to significantly reducing expenses, this restructuring We'll also significantly reduce our cost of sales and increase gross margins on an ongoing basis. I would like to extend our heartfelt appreciation and best wishes to the employees impacted by the reduction in workforce. Realigning our operating plan and cost structure involves some difficult but necessary decisions to ensure financial discipline while continuing to invest in our commercial launch success. Notably, our registrational and early phase programs remain on track, and no significant changes to our product pipeline are expected. Our net cash burn is significantly reduced over our prior forecast. For the next four quarters through the second quarter of 2025, net cash burn is expected to be less than $245 million, excluding one-time charges of less than $6 million associated with the third quarter strategic restructuring. We will continue to optimize and refine our cost structure through operational excellence initiatives over the next two to three quarters, And importantly, we expect ongoing reductions in expenses and improvements in cost of sales. Our current cash position of approximately $307 million in anticipated product revenue, including cost savings from the strategic restructuring, are expected to be sufficient to fund current and planned operations into the fourth quarter of 2026. I am happy to go into more detail during the Q&A. Notably, we are excited to welcome our new Chief Financial Officer, Corleen Roche, who joined our team this week. We look forward to Corleen covering the financial results in detail from next quarter onwards, and she's available for today's Q&A session. I will now turn the call over to Dan Kirby, Chief Commercial Officer, for a detailed update on our commercial launch and our XOS regulatory milestones.