speaker
Daniel
Conference Call Operator

Welcome to the Iovance Biotherapeutics second quarter 2026 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 Sara Pellegrino, Senior Vice President, Investor Relations and Corporate Communications at Iovance. Sara, you may begin.

speaker
Sara Pellegrino
Senior Vice President, Investor Relations and Corporate Communications

Thank you, operator. Good morning, and welcome to the Iovance webcast to discuss our second quarter of 2026 financial results, business achievements, and corporate updates. This morning, we issued a press release that is available on our corporate website at iovance.com. 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, Submissions, Feedback and Guidance, Plans and Strategies, Research and Preclinical Activities, Potential Future Applications of Our Technologies, Manufacturing Capabilities, Payer Interactions, Licenses and Collaborations, Cash Position 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 FTC 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 turn the call over now to Dr. Fred Vogt, Interim CEO and President.

speaker
Dr. Fred Vogt
Interim CEO and President

Thank you, Sara. IVANCE is the global leader in innovating, developing, and delivering tilt therapy for solid tumors. Today and for the next generation. The second quarter of 2026 was our strongest yet. We delivered record revenue and margin, advanced our pipeline, and secured important new regulatory approvals and designations. I'll start by highlighting a few notable achievements. First, our commercial launch reached new heights in the second quarter, while our foundation for growth expanded. More authorized treatment centers, or ATCs, are activating, enrolling, and infusing patients than ever before. We reported $99.3 million in revenue, driven by record Ampagni demand. We also greatly exceeded both our Ampagni and total revenue guidance ranges for the second quarter. Second quarter margin also reached an all-time high of 56%. We expect margin to keep expanding as we increase revenue, fine-tune execution, and gain efficiency and scale. Looking ahead, we maintain our peak assumptions for Ampagni and Perlucan of more than $1 billion in U.S. sales from advanced melanoma alone. The opportunity and other indications is significantly larger. Our third quarter performance of data is very strong. Once we fully assess increasing growth trends, we expect to provide an update to our four-year guidance during the third quarter. We are now providing commercially untagged to more than 50 patients a month on top of increasing numbers of clinical patients, which demonstrates both our manufacturing scale and how broadly accessible our cell therapies have become. We are not choosing between growth and discipline. This quarter, we delivered both. Research and development expenses improved for the fourth consecutive quarter, even as every lead program advanced and our pipeline grew. We are closing in on our pursuit of the largest opportunities for cancer patients who have the greatest on that need. Our technology platform is scaling quickly. Recent regulatory and clinical milestones bring teletherapy forward for more patients in the U.S., as well as new markets and additional solid tumor indications. Nearly 2,000 patients have received Iovance pill therapies in commercial and clinical settings across hundreds of centers in the U.S. and in 30 countries. Over the coming years, our vision is to reach tens of thousands of patients. In our registrational trials, enrollment is nearly complete in our Lung 202 trial in the pivotal cohorts in non-squamous, non-small cell lung cancer. This indication represents a blockbuster opportunity that is roughly seven times that of advanced melanoma. We look forward to providing program updates in the fourth quarter as we work toward a supplemental biologics license application in 2027. We're moving quickly with our registrational Saratoga trial for SAR201 and two advanced soft tissue sarcomas. As we announced today, the US FDA granted fast track designation in undifferentiated pleomorphic sarcoma and de-differentiated liposarcoma, validating the promise of the initial clinical data for lifelucel as well as the substantial unmet medical need in both indications. In a pilot study with one-time life elusal therapy, the objective response rate was an unprecedented 50% in the first six valuable patients compared with abysmal response rates of less than 5% using current standard of care in these refractory treatment settings. Our translational data and state-of-the-art technologies are uncovering the next frontier in TIL therapy. We are now able to identify highly responsive patient populations across solid tumor indications Thank you for joining us. Tilt therapy includes continuous investment in next-generation programs. A new trial, known as G1-Tilt-1, is using IOB5001, our next-generation IL-12 tethered tilt therapy. This Phase 1-2 BASCA trial will run across prevalent solid tumors representing more than 100,000 U.S. deaths annually, including metastatic colorectal, triple negative breast, and estrogen-receptor low breast cancers. We expect to provide more updates this year. Today, profitability is the site, and with it, lasting value for patients and shareholders alike. iAdvance is the first and only company in the world to take pill therapy from concept to commercial treatment for patients, supported by our scalable manufacturing infrastructure, clinical breadth, commercial experience, and operational discipline. With healthy commercial momentum, broadening pipeline, and solid execution, iAdvance has never been better positioned for long-term success. I'll now ask Corleen Roche, our Chief Financial Officer, to detail our financial results.

Disclaimer

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