Autolus Therapeutics plc

Good day everyone and welcome to Out of Loss Therapeutics first quarter 2026 financial results conference call. At this time all participants are in a listen only mode. After the presentation there will be a question and answer session. To ask a question you will need to press star 1 1 on your telephone. You will then hear a 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 turn the call over to the Executive Director of Investor Relations, Amanda Cray. Please go ahead.

Thank you, Carmen. Good morning or good afternoon, everyone, and thank you for joining us on today's call. With me, our 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 OCATSL in the U.S. and U.K., auto list manufacturing sales and marketing plans for OCATSL, the market potential for OCASL, and the status of clinical trials, development and or regulatory timelines, and market opportunities for OB-SEL. 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 statements. 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 Investors 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 will turn it over to Christian.

Thanks, Amanda, and welcome everyone to our first quarter update. Moving to slide number four, we had a very good first quarter, and we see nice traction building both in the U.S. and obviously in our early launch in the U.K. as well. In Q1, we had $26.2 million in revenue booked. And we do see a very nice penetration and deepening with the positive physician experience that was highlighted at the tandem meeting as part of the ROCA consortium presentation, where we had approximately 60% of our commercial patients represented in that data set. And we had discussed the data at the full year update, which was gave a few weeks ago and also was further analyzed and reviewed in the context of a KOL call we did in the early part of April. When we then look into the UK, we do see very good start in the UK. We have more than 10 centers already active. We're going very strong in the UK with regards to not only central onboarding, but also start to see early patients come in and actually become treated under the NHS access program. Now, when we look into the 2026 overall outlook, we do see that we have a very nice continued momentum. We're currently from a perspective of US centers already at around 73 centers and we're increasing beyond 80 centers by the end of the year. Our full year guidance is unchanged at $120 to $135 million. And for the first time this quarter, we did see a shift to positive gross margin, which is important because obviously this is one of the key metrics that we're looking at during the course of this year to start to actually see that the overall commercial base and our ability to ultimately drive a proper cash flow into the company increase over time. So first time, positive gross margin, and obviously a lot of that impacted by, on the one hand, an increase in volume, but also operational improvements that we made to the overall operation of the company, but in particular, the operation of the manufacturing plant that we're running. So this is where we are with regards to the overview from a commercial perspective for a capsule. Very good dynamic and we believe very strong momentum as we go into Q2. So with that, we're going to slide number five. I would like to start in the right hand side and just briefly talk about the journey that we're on with regards to moving the products to a place where indeed we have a profitable ALM business. The foundation was really late during the first year of launch, and what we had to establish during that first year of launch is consistent and high-quality product supply and services so that we have a strong front-end foundation, we serve our patients properly, and we can generate very strong outcomes in these patients. And you've seen all of that actually presented as part of the Rocket Consortium's experience, which had actually almost all patients that were intended to be treated actually received treatment. And we also did see that that treatment actually translated into a very positive safety profile with no high-grade CRS, only 3% high-grade ICANNs, and more than 90% overall response rate in the patient. So a remarkable outcome in the hands of the physicians in the real-world setting. And we're also starting to see that we're already start to see branching out of the patient pool into patients that actually are older, have more comorbidities, typically tend to be considered difficult to treat. That's one expansion that we've seen, but also an expansion into patients that have a very limited tumor burden. And with that, obviously, what we have seen in our prior studies certainly have a good opportunity to sort of get a more pronounced benefit over time. So we've seen an expansion already in terms of the patient pools. That is very important because based on that behavior, as well as the good safety profile, we do expect that that forms a very strong foundation. And we see that translate actually already in the first few months in 2026. The second stage now, as soon as we actually had established consistent high quality products, supply and services, That is actually when we switched gears and really started to drive optimization, improve efficiency, as well as at the same time, obviously increase the volumes that actually were driving through the overall operation. And with that, have an ability to actually get our overall costs down for the products. We expect the peak at the peak ALL business to be around 65 to 70% gross profit margin. which gives us a very healthy business on for the ALL side of our capital. Now, the optimization we ran through obviously also was not just an optimization in processes, but also with that, obviously we have run through a reduction in force at the company of 13%. And we also at the same time have driven up the efficiency that were running within the operation. And you'll see that in a very simple metric, we expect to produce twice as much product this year compared to last year with overall staffing that is at or below the levels that we had last year. So that gives us a very clear understanding of why indeed these gross margins are moving into the positive and will continue to improve as we go through the course of this year. Now, overall, as once the one-time effect of the restructuring is taken care of, and you'll see that pass through, and Rob will talk to that briefly, we expect for 2027 a net impact of a savings of $15 million on an annualized basis. When we then look onto the development side and leveraging the exceptional profile that we now not only are seeing in clinical trials, but see it translated also in the real-world setting, We're also building on that set of properties into a range of additional indications. The first one, clearly, to extend the treatment from the adult population into the pediatric population. And we have the phase two expansion of the catalyst study ongoing. Data is expected towards the end of 2027, and we have aligned with the FDA on the protocol design and support for potential registrations. The second study, obviously, that is progressing well, we expect actually data during additional data towards the end of this year is the Carlisle study where we have added additional patients and we're also obviously will have substantial more follow up in that patient population. And I think that will give us a very good understanding of the type of benefit that indeed a capsule or OB cell can induce. in indications now beyond oncology, in this case, in a refractory form of systemic lupus. The next study that is actively enrolling is the LUMINA study, which is in lupus nephritis. This is the phase two study where we have agreement with the agency based on this study aimed for a registration in refractory lupus nephritis. The study is active in certain countries in Europe as well as the U.S., and we're expecting data from the study in 2028. Finally, the study that will get us into neurological diseases is the progressive multiple sclerosis study that we're conducting, which is the Bobcat study. This study is continuing to enroll, and we expect initial data at the end of this year and then full data during the course of next year. When we look a bit more broadly, we also obviously will have additional data collection through the ROCA consortium, which is actually continuing to collect information from patients treated with commercial product and actually starting to look at quite a range of questions related to the performance of the product and the properties of the product with a clear view from the real-world setting. In addition, and this was also part of the KOL call that I referenced before, we're seeing investigator-sponsored studies starting that actually are looking at the use of OpiCell in a frontline consolidation setting, which is ultimately aiming to explore whether indeed an abbreviated frontline treatment might be possible and where, obviously, Very interested to see how the product performs in those settings, and we expect our investigators to report in upcoming conferences on their studies. With that, I'm at the end of the introductory remarks, and I will hand over now to Rob for the financial results.