8/26/2025

speaker
Operator
Conference Operator

And welcome to ADAPT Immune's first quarter 2025 Business Update conference call. As a reminder, all participants are in listen-only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. To join the question queue, you may press star, then 1 on your telephone keypad. Should you need assistance during the conference call, you may signal the operator by pressing star, then 0. I will now turn the call over to Julie Miller of Investor Relations for Adaptimmune. Julie, please go ahead.

speaker
Julie Miller
Head of Investor Relations

Thank you. Good morning, and welcome to Adaptimmune's conference call to discuss our first quarter 2025 business update. I would ask you to review the full text of our forward-looking statements from this morning's press release. We anticipate making projections during this call, and actual results could differ materially due to several factors. including those outlined in our latest filings with the SEC. Adrian Rockliffe, our Chief Executive Officer, is here with me for the prepared portion of the call, and other members of our leadership team will be available for Q&A. With that, I'll turn the call over to Adrian Rockliffe.

speaker
Adrian Rockliffe
Chief Executive Officer

Thanks, Julie, and thank you, everybody, for joining us today. We now have one full quarter of T-cellular sales under our belt. and I'm delighted to be able to share with you the momentum that we're seeing with this launch. With 21 patients A4E so far in 2025, 13 in Q1, and another eight in the first part of Q2, we now feel confident sharing revenue guidance for the full year of between $35 million and $45 million in T-cellular sales. We believe this is attainable based on the number of patients we've seen through the treatment cycle, as well as the number of authorised treatment centres that we have up and running. As of today, we have a total of 28 centres accepting referrals for patients for Tesora, and it's very clear that we will have the full network of approximately 30 ATCs up and running by the end of 2025. This is approximately a year earlier than we expected when we launched. During these first few quarters of the T-cellular launch, we will continue to share key performance indicators in addition to net sales, such as the number of apheresis that I previously mentioned and the number of T-cellular treatments invoiced. We have invoiced for 14 T-cellular treatments in 2025 to date, with six in Q1, resulting in net sales for Q1 of $4 million. We have since invoiced eight additional treatments in the first few weeks of Q2, We've also continued to deliver 100% manufacturing success from our US T-cellular manufacturing center in Navy Yard, Philadelphia, with all T-cellular doses released to date meeting specification, with no capacity issues or constraints. And in the first quarter, our average turnaround time from apheresis to lot release was 27 days, beating our target of 30 days. On the payer front, we've seen effective patient access to T-Cellular with no patient denials to date. So in every aspect, the T-Cellular launch is progressing exceptionally well, forming the basis for our projected $400 million of peak sales from our combined T-Cellular and Leticel sarcoma franchise. The team at Adaptimmune has remained focused, diligent, and absolutely committed to this successful launch. Also, I'll remind you that the investments in people and infrastructure that we've put in place for T-Celra will be the same for Leticel when approved, which we anticipate in 2026. We'll use the same ATC network and work alongside many of the same physicians. Leticel launch readiness activities are underway and we are fully on target for a rolling BLA initiation for the end of the year. As you know, Leticel has the potential to more than double the addressable patients in our sarcoma franchise, as we anticipate an indication of both synovial sarcoma and myxoid round cell liposarcoma patients whose tumour express NYISO. It's worth noting that given the ubiquitous nature of NYISO expression in myxoid liposarcoma patients, we do not anticipate the need for NYISO antigen testing in this population. further simplifying the patient journey and expanding the patient population. We continue to review strategic options with Cowen as our advisors and are committed to explore all options that benefit patients and shareholders. We look forward to sharing more information on next steps in this process in the upcoming months. And with that, I'll open the call for questions. Operator?

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