Frederick Vogt
Analyst · Jefferies
Thank you, Sara. Iovance is the global leader in innovating, developing, and delivering TIL 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 Amtagvi demand. We also greatly exceeded both our Amtagvi 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 at scale. Looking ahead, we maintain our peak assumptions for Amtagvi and Proleukin of more than $1 billion in U.S. sales from advanced melanoma alone. The opportunity in other indications is significantly larger. Our third quarter performance to date is very strong. Once we fully assess increasing growth trends, we expect to provide an update to our full year guidance during the third quarter. We are now providing commercial Amtagvi 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 unmet need. Our technology platform is scaling quickly. Recent regulatory and clinical milestones bring TIL therapy 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 TIL 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 LUN-202 trial in the pivotal cohorts in non-squamous, non-small cell lung cancer. This indication represents a blockbuster opportunity that is roughly 7x that of advanced melanoma. We look forward to providing program updates in the fourth quarter as we work towards supplemental Biologics License Application in 2027. We're moving quickly with our registrational SARATOGA trial for SAR-201 in 2 advanced soft tissue sarcomas. As we announced today, the U.S. FDA granted Fast Track designation in undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma, validating the promise of the initial clinical data for lifileucel, as well as the substantial unmet medical need in both indications. In a pilot study with one-time lifileucel therapy, the objective response rate was an unprecedented 50% in the first 6 evaluable 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 that comprise more than 90% of all cancers. For example, a histology-based biomarker strategy produced striking early Phase 2 data in the first 5 evaluable patients with metastatic serous endometrial cancer. In our END-201 trial, we reported a 40% confirmed objective response rate and a 100% disease control rate. We are submitting a protocol amendment and engaging with the FDA on an expedited approval pathway based on this patient population. Our leadership in TIL therapy includes continuous investment in next-generation programs. A new trial, known as GE1-201 is using IOV-5001, our next-generation IL-12 tethered TIL therapy. This Phase I/II basket 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 positive breast cancers. We expect to provide more updates this year. Today, profitability is in sight, and with it, lasting value for patients and shareholders alike. Iovance is the first and only company in the world to take TIL 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, Iovance has never been better positioned for long-term success. I'll now ask Corleen Roche, our Chief Financial Officer, to detail our financial results.