Iovance Biotherapeutics, Inc.

Welcome to the Iovance Biotherapeutics third quarter and year-to-date 2025 conference call. My name is Daniel, 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 call is being recorded. I will now turn the call over to Sarah Pellegrino, Senior Vice President in Best Relations, and Corporate Communications at Iovance. Sarah, you may begin.

Thank you, Operator. Good morning, and welcome to the Iovance webcast to discuss our business achievements, pipeline milestones, and third quarter 2025 results. Members of our executive leadership team speaking on today's call include Dr. Fred Vose, Interim CEO and President, Coraline Roche, Chief Financial Officer, Dan Kirby, Chief Commercial Officer, Dr. Igor Balinski, Chief Operating Officer, and Dr. Frederick Finkenstein, Chief Medical Officer. During the question and answer session, we will also welcome Drs. Raj Puri and Mark Suray from our Regulatory Affairs Executive Leadership Team, and Dr. Brian Gassman, Executive Vice President of Translational Medicine and Research. This morning, we issued a press release that is available on our corporate website at iobance.com. I would like to remind everyone that 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 interaction, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interaction, restructuring, 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. I will now like to turn the call over to Fred.

Thank you, Sarah. I will start by sharing our continued progress to increase revenue and margins, advance our pipeline, reduce expenses, and improve operational execution. Third quarter revenue grew 13% over the prior quarter, and notably gross margin improved and was 43% following the initial results of our strategic restructuring and cost optimization. More improvements are coming, including today's announcement of our centralization of manufacturing at our internal manufacturing facility. Our highest priority is to accelerate revenue growth to increase the impact of the adoption across our network of academic and community authorized treatment centers, or ATCs. We've expanded to include new academic ATCs and multiple community ATCs. Initial patients are being treated in the community and are generally earlier in their melanoma treatment journey. As we educate community oncologists across our ATCs, including the major academic centers, we are seeing earlier, more frequent patient referrals that drive growth. Rare world data showed response rates of 60% in the second line treatment setting, has provided a strong foundation to amplify our compelling story to the melanoma community for the power of till therapy and melanoma we are on track to achieve our revenue guidance range of 250 to 300 million dollars for the full year of 2025. with robust current demand we expect a strong fourth quarter of ram tagby alongside increasing proleukin sales as we saw in late 2024. We continue to project antagonistic peak sales of more than $1 billion in the U.S. in melanoma, with larger additional opportunities in international markets and in future indications. For example, our interim clinical data in previously treated non-squamous, non-small cell lung cancer showed a best-in-class... Excuse me. Apologies for technical difficulty here. One second. For example, our intraclinical data in previously treated non-slammable non-small lung cancer showed a best-in-class profile and unprecedented durability compared to standard of care in this population, including an objective response rate of 26% and a median duration of response not reached at more than 25 months of follow-up. There is a significant market opportunity in this lung cancer indication, which is about seven times greater than our current advanced melanoma indication. We expect to quickly complete enrollment in our Lung 202 Registrational Trial in 2026 with approximately 80 patients. This sample size will support an accelerated approval given the unmet need in non-small cell lung cancer, precedent of the Ampagni approval in 73 melanoma patients, and recent accelerated approvals based on 70 to 80 patients defined non-small cell lung cancer population the usfda previously provided positive feedback on our trial design which aligns with fda guidance for single arm trials to support accelerated approvals for single agents in conditions with unmet medical need we look forward to advancing toward a supplemental biologics license application in non-squamous non-small cell lung cancer and a potential launch in the second half of 2027. As we increase revenue and advance our pipeline, we are laser focused on expense management profitability. Following our third quarter reorganization, we are finding our operating plan to ensure we are appropriately investing in our commercial launch and high value programs. Again, cost of sales and gross margin will improve significantly as we transition manufacturing to our internal facility in early 2026. During this call and our future quarterly updates, we will highlight our ongoing efforts toward further expense reductions and resource allocation. Corleen will now highlight our third quarter financials in further detail.