Iovance Biotherapeutics, Inc.

Good day, and thank you for standing by. Welcome to the Iovance Biotherapeutics fourth quarter and full year 2025 financial results and corporate updates conference call. At this time, all participants are in a listen-only 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 11 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 at Iovance. Please go ahead.

Thank you, operator. Good morning and welcome to the Iovance webcast to discuss our fourth quarter and full year 2025 financial results business achievements, and corporate updates. This morning, we issued a press release that is available on our corporate website at IOVANS.com. This conference call will include forward-looking statements regarding IOVANS' goals, business focus, business plans and transactions, revenue, commercial activities, clinical trials and results, regulatory approvals and interactions, plans and strategies, research and preclinical activities, potential future applications of our technology, 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. I will now turn the call over to Dr. Fred Voth, Interim CEO and President of Iovance.

Thank you, Sarah. In 2025, Iovance delivered substantial revenue growth, achieved groundbreaking data milestones, and strengthened our financial performance. Our fourth quarter and full year 2025 results underscore our focus on value creation for patients and shareholders. We drove MTAGV adoption while streamlining costs and optimizing operations. Our operational strength resulted in a robust 30% revenue growth driven by MTAGV and our best ever 50% margin from cost of sales in the fourth quarter. For the full year, total revenue of about $264 million was well within our annual guidance Our cash runway, bolstered by our ongoing cost savings initiatives, now extends into the third quarter of 2027. Following our exceptional performance in 2025, we are well positioned in 2026 to surge toward a highly profitable and broad business in solid tumor cancer immunotherapy. We plan to execute across three core pillars. First, continue accelerating our U.S. commercial launch of Ampagni and advanced melanoma. Second, harness the power of our tilt pipeline to expand into new indications and next-generation products. And third, hone our operational excellence as our foundation for success. First and foremost, we're gaining positive uptake commercially with significant potential for Amtagby and Perlucan to reach $1 billion-plus U.S. sales at peak. After a considerable increase in fourth-quarter demand for Amtagby, Enrollment volumes in 2026 are accelerating within our broad and continuously expanding network of both academic and community authorized treatment centers, or ATCs. These ATCs are further reinforced by excitement surrounding the real-world experience and benefits of early treatment with mTAGV. On top of increasing demand, we are benefiting from operational improvements throughout the entire mTAGV treatment journey, from patient identification through manufacturing to infusion. When the heels of positive momentum in the fourth quarter, we expect remarkable revenue growth in 2026, driven by Amtagme. In the very near future, we will provide revenue guidance with our growth projections. Our second pillar is the massive expansion potential for our TIL platform to positively impact patients into new indications. We are harnessing the overlap and scalability of our TIL platform, manufacturing leadership, and commercial capabilities across solid tumors. Our lead indication for Lifolucel is in previously treated non-squamous, non-small cell lung cancer. This blockbuster US market is about seven times larger than our PQS sales opportunity in advanced melanoma. In our registrational patient population, Lifolucel has demonstrated best-in-class clinical response rates and durability. This morning, we announced the FDA has granted fast-track designation that validates our clinical trial data and reaffirms the substantial medical need for lepilucel in this indication. We are rapidly advancing toward a supplemental biologics license application with a potential accelerated approval and launch in the second half of 2027. This morning I am also excited to introduce entirely new indications for lepilucel announced in the press release alongside positive early data. In previously treated patients with two aggressive difficult to treat advanced soft tissue sarcomas, Leifeluzel demonstrated an unprecedented 50% confirmed response rate. As Brian will highlight, Leifeluzel may offer the first durable immunotherapy option in this treatment setting. Current outcomes with standard of care are abysmal, with response rates below 5% and short median overall survival of only 9 to 10 months. Together, these sarcomas impact more than 8,000 patients in the U.S. and Europe annually, significantly increasing our market opportunity for Leifeluzel in the U.S. and beyond. We're working expeditiously to initiate and complete a single-arm registrational trial to launch in these sarcomas. Our robust pipeline is the backbone of immuno-oncology in multiple-cell tumors today and in the future, as we build upon our established global leadership and define next-generation approaches for TIL cell therapy. Our two clinical-stage, genetically-engineered TIL therapies have the potential to transform the treatment paradigm across a vast number of solid tumor cancers, where patients have few options. Our next generation IL-2 product may facilitate more accessible tilt therapies. And we expect to provide many more updates on our pipeline in 2026. Finally, our third pillar is operational excellence, as we increase revenue, optimize costs, and drive efficiencies toward profitability. In the fourth quarter, we reported our best ever gross margin, as Corleen will discuss. Additionally, our ongoing execution, discipline, and focus on financial excellence will improve current and future gross margin and further extend their cash runway. Within our operational excellence pillar, as Igor will highlight, manufacturing success has improved across the board. By optimizing our processes, we have infused more patients while reducing dropouts to be more efficient ahead of future launches. Importantly, we own and control all manufacturing for Amtagni within our U.S.-based Diaban Cell Therapy Center, or ICTC, as well as critical components of our supply chain. We have never been in a stronger position to execute while scaling to new heights. In 2026, we are laser-focused on maximizing shareholder value, ending dilution, and supercharging future profitability. I'll now turn the call over to Coraline Roche, our Chief Financial Officer, who will provide further updates on our fourth quarter and full-year financials.