Adaptimmune Therapeutics plc (NASDAQ:ADAP) Q4 2023 Earnings Conference Call March 6, 2024 8:00 AM ET
Company Participants
Juli Miller - Investor Relations
Adrian Rawcliffe - Chief Executive Officer
Gavin Wood - Chief Financial Officer
John Lunger - Chief Patient Supply Officer
Jo Brewer - Chief Scientific Officer
Conference Call Participants
Graig Suvannavejh - Mizuho Securities
Jonathan Chang - Leerink Partners
Yanan Zhu - Wells Fargo Securities
Operator
Hello and welcome to Adaptimmune's Fourth Quarter and Year-End Conference Call and Business Update.
I will now turn the call over to Juli Miller. Juli, please go ahead.
Juli Miller
Good morning, thank you for joining us. Welcome to our Q4 and full-year 2023 update and I refer you to our disclaimer here, as well as our forward-looking statements in this morning's press release.
For the prepared portion of the call, Adrian Rawcliffe, our CEO, is with us, and other members of our management team are available for Q&A.
With that, I'll turn the call over to Adrian. Ad?
Adrian Rawcliffe
Thanks Julie. Thanks everyone for joining today. So I planned today to recap the progress we made in 2023 and share a little bit about our plans for 2024. I'll be focused primarily on a Afamicel, which will be our first commercial product in our sarcoma franchise.
2023 was a year of transformation for Adaptimmune. We completed a corporate restructuring and a merger with TCR Squared. And following that, we undertook a clinical pipeline review focusing on the highest priority and value assets. We recovered Letecel and PRAME from GSK. I want to remind you that Letecel came with a fully enrolled pivotal trial that has already met its primary endpoint for efficacy at the interim analysis, which was disclosed late last year.
We also submitted the BLA for a Afamicel. This is a significant milestone for adapting, you know, obviously, but it's also a significant milestone for the sector as the first ever BLA for an engineered cell therapy for a solid tumor indication. As well as the submission, we took the opportunity working with the RMAT designation to understand the FDA's requirements on a number of areas and de-risk that file and also sought the FDA's agreement on the opportunity for the second cohort of that SPEARHEAD-1 trial to provide the confirmatory evidence for full approval.
Afamicel is the first product in our sarcoma franchise, a franchise that we estimate has PTO sales of up to $400 million. And as such, it's a beachhead for innovative cell therapy products in the solid tumor space. It's the first product of our wholly-owned pipeline of cell therapy products with the most significant of those in clinical development being a product that was previously known as ADPA2M4CD8, but has now been granted the user name of uzatresgene autoleucel or uzacel. Uzacel has been developed in ovarian, bladder and head and neck cancer, and all of this is enabled by our long-term investment in the capabilities needed to be a cell therapy company. That means that at this point, we have the opportunity to transition into a fully integrated commercial stage company, discovering, developing, and now importantly delivering cell therapy products to patients.