Iovance Biotherapeutics, Inc.

Good day, and thank you for standing by. Welcome to the Iovance Biotherapeutics First Quarter 2026 Financial Results 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 11 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, SVP of Investor Relations and Corporate Communications. Please go ahead.

Thank you, Operator. Good morning, and welcome to the Iovance webcast to discuss our first quarter 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 IOVAMS' 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 collaboration, 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 turn the call over to Dr. Fred Vose, our Interim Chief Executive Officer and President.

Thank you, Sarah. Iovance is the global leader in innovating, developing, and delivering current and future generations of TIL cell therapy in solid tumors. We are executing to maximize patient and shareholder value across four pillars, curative platform potential, commercial execution, technology extension, and fully-owned manufacturing. During the first quarter of 2026, we drove anti-antagony adoption, advanced our development pipeline, and streamlined costs and efficiencies. First quarter revenue grew approximately 45% year-over-year. Owning manufacturing is critical for our success. We navigated a temporary capacity reduction to complete maintenance upgrades at our internal manufacturing facility, the ICPC. Since resuming full production, Ampagni is now exclusively manufactured in-house and our modular facility can provide uninterrupted supply while supporting global demand and scale. Research and development expenses declined for the third consecutive quarter, helping to extend our cash run way into 2028. Looking ahead, MPAGNY enrollment and referral trends are at an all-time high in support of our second quarter and full year 2026 guidance issued today. Second quarter total revenue guidance is $86 million to $88 million. MPAGNY revenue is expected to grow to $79 million to $81 million in the second quarter, This is an increase of approximately 23% over our highest quarterly revenue to date in the fourth quarter of last year. For the full year of 2026, total revenue guidance for Ampagni and Prolucan is $350 to $370 million, predominantly fueled by Ampagni. Over time, we project a $1 billion plus peak out sales trajectory for Ampagni and Prolucan in the U.S. For the rest of 2026 and beyond, we expect gross margin to benefit from our financial discipline, in-house scale, and operational efficiencies. Shifting to our TIL platform, we're expanding the curative potential across solid tumors. This morning, we announced compelling and clinically differentiated early phase two data in metastatic serous endometrial cancer. The confirmed objective response rate was 40%, with a 100% disease control rate in the first five patients. Metastatic serous endometrial cancer is difficult to treat with an estimated 5,000 annual U.S. deaths. The second-line treatment setting represents a significant unmet medical need with response rates below 15%. We plan to engage with the U.S. FDA to pursue an expedited approval pathway. I will now highlight additional registrational trials for Leifelucel and new indications. To expand the Antagni's market potential into advanced frontline melanoma, we continue to execute our global TILBANS 301 trial. In previously treated non-squamous, non-small-cell lung cancer, Lypilosa received FDA Fast-Track designation following best-in-class unprecedented response rates and strong durability. This U.S. blockbuster market is about seven times larger than our peak opportunity in advanced melanoma. We plan to complete enrollment and provide a clinical update this year, targeting accelerated approval and U.S. launch in the second half of 2027. In advanced and difficult-to-treat soft tissue sarcomas, IFV SAR 201, our new registrational trial, is underway in refractory patients with advanced undifferentiated pleomorphic sarcoma and de-differentiated liposarcoma. The trial is beginning enrollment in the third quarter of 2026. We are building upon positive early clinical results with a 50% confirmed response rate in comparison to the abysmal response rates of less than 5% with current standard of care. We are actively engaging with FDA soon on a path to expedited approval. As the global leader in tilt cell therapy, we are making significant progress to our next generation programs. ILB5001 is our IL-12 tethered tilt therapy for highly prevalent solid tumors. A prior generation IL-12 tilt therapy at the National Cancer Institute improved clinical efficacy without IL-2 and informs how we optimize ILB5001 to enhance efficacy and safety. We recently submitted the investigational new drug, or IMD, application for a phase one slash two clinical trial, which includes indications that represent more than 15% of US cancer deaths annually. Among these indications are advanced colorectal cancer, as well as triple negative and estrogen receptor low breast cancers, adding large populations and massive commercial opportunities to our strategy. The trial is expected to begin in the second half of 2026. Our next-generation IL-2 product, IV3001, may optimize the tilt treatment regimen. A Phase I safety core using IV3001 is advancing to multiple dose levels in a Phase I-II trial. We continue to enroll in our clinical trial with our P1-inactivated tilt therapy, IV4001, which reduces inhibitory signals to enhance the ability of tilt therapies to fight and kill cancer. We are initially exploring melanoma and non-small cell lung cancer. We look forward to reporting data and updates soon. As we expand our clinical strategy in solid tumor cancers, we now have the opportunity and capability to identify enriched patient populations that are highly responsive to TILT therapy. We are identifying these enriched populations, such as the serious endometrial cancer population we highlighted today, and our selected populations within soft tissue comas and even within non-small cell lung cancer and other indications, which you will hear more about later this year. IVANS is well-positioned as the only company to have taken tilt therapy from concept to commercial scale. With the manufacturing infrastructure, clinical breadth, commercial experience, and operational discipline to back it up, we have momentum, a broadening pipeline, and an improving line of sight to profitability. The foundation is built, and as we continue to expand across indications, our ambition is clear, to extend our leadership not just in TILT therapy, but as the backbone of immuno-oncology in solid tumor cancers. As I conclude this pipeline update, I would like to extend my sincerest gratitude to Frederick Finckenstein, our chief medical officer, as he prepares to retire in June. During nearly seven years at Iovance, he was instrumental in leading us towards the FDA approval of the first ever TILT therapy, and our leadership position today. Frederick is available during today's question and answer session, and I wish him the best in his retirement. I will now turn the call over to Coraline Roche, our Chief Financial Officer, who will provide further updates on our first quarter financials and full year expectations. Coraline.