Autolus Therapeutics plc

Good day, and thank you for standing by. Welcome to the Autolist Second Quarter 2025 Financial Results Conference Call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. You will then hear an automated message of asking your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised, today's conference is being recorded. I would now like to hand the conference over to your speaker today, Amanda Cray, Executive Director, Investor Relations. Please go ahead.

Thank you, Kevin. Good morning or good afternoon, everyone, and thank you for joining us on today's call. With me are Chief Executive Officer Dr. Christian Eiten and Chief Financial Officer Rob Dolski. I'd like to remind you that during today's call, we will make statements related to our business that are forward-looking under federal securities laws and the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These may include, but are not limited to, statements regarding status of the ongoing commercial launch of OCASEL, autolysis manufacturing, sales, and marketing plans for OCASEL, the market potential for OCASEL, and the status of clinical trials, development, and or regulatory timelines and market opportunities for OB-Cell and our other product candidates. These statements are subject to a variety of risks and uncertainties that could cause actual results to differ materially from expectations and reflect our views only as of today. We assume no obligation to update any such forward-looking statement. For a discussion of the material risks and uncertainties that could affect our actual results, please refer to the risks identified in today's press release and in our SEC filings, both available on the investor section of our website. On slide three, you'll see the agenda for today's call, As usual, Christian will provide an overview of our operational highlights. Rob will then discuss the financial results. And Christian will conclude with upcoming milestones and closing remarks. We'll then take questions. With that, I'll turn it over to Christian.

Thank you, Amanda. And moving to slide four. Welcome, ladies and gentlemen, and thank you for joining us for the second quarter call. We had an excellent second quarter with good momentum in our launch of a capsule. In the second quarter, we generated $20.9 million in product sales, bringing the first six months of the launch to $29.9 million. The product profile resonates very well with treating physicians, and there is a clear unmet medical need. Our supply chain has proven to be robust, reliable, and delivering consistent quality to our customers. We continue to expand our center presence with now 46 centers authorized for use of a capsule, and 90% total U.S. medical lives covered. We are well on track to achieve our year-end objective of reaching 60-plus authorized centers. As of July 1st, we have permanent HCPCS code effective, following a positive CMS decision on April 1st. The decision by CMS of a split reimbursement based on the infusion of product was a deviation of precedence. The impact was twofold. a change in revenue recognition for the company, and an adjustment of the administrative processes at the medical centers. The adjustments were made during the second quarter and did slow patient enrollment at those centers. We expect the impact on patients treated to be resolved by Q4. Moving to slide number five, we're very pleased with the progress of our regulatory filings. In April, we received conditional marketing authorization in the UK and in July from the European Commission. We're working on market access in the UK and are interacting with NICE. In the EU, we are looking at a country-by-country evaluation. While we aim to get Ocancel to as many patients as possible, as a small company with limited resources, we also have to be disciplined and make sure to only launch where market access is economically viable. At this stage, we do not expect EU sales in 2025 and 2026. Meanwhile, we continue to engage with physicians and study groups, like the German ALL study group, to enable ISTs in Europe. In addition, we are broadening our real-world experience in the US with OBSEL, which may provide additional support for our market access conversations elsewhere. Moving to slide number six. The Felix data continued to mature very favorably. At EHA, we presented an update with 32.8 months of median follow-up. Importantly, 38% of the responding patients remain in remission without any subsequent treatment. On slide seven, consistent with this finding, we see median duration of response reached 42.6 months. Slide eight, then, looks at the overall survival, which shows a plateau forming at around 40%, with most patients beyond two years of observation. A long-term outcome, together with a favorable safety profile, is a strong foundation to build on. Where Next with OB-Cell is summarized on slide 9. Our development focus is on expanding the ability of OB-Cell beyond adult patients with relapsed refractory ALLs. We made good progress with our pediatric study, PY1. We expect the phase one experience to be presented by the year end and are expanding the study from a phase one to a phase one two study with an intent to expand the age range for our current label. Encouragingly, several of the physicians treating commercial patients expressed an interest in exploring OB cell in frontline consolidation settings and we expect to see several ISTs active in 2026. We are also excited about our progress in autoimmune diseases. Building on the encouraging initial experience in SLE, we are starting up a phase two lupus nephritis study with registrational intent. In addition, our phase one study in progressive multiple sclerosis is open for enrollment now. With that, I'm handing over to Rob for the financial results for the second quarter 2025. Rob.