Adaptimmune Therapeutics plc

Good morning, ladies and gentlemen, and welcome to the Adaptimmune Q1 2024 Financial and Business Update Conference Call. I would now like to turn the meeting over to Ms. Julie Miller. Please go ahead, Ms. Miller.

Good morning, and welcome to our conference call to discuss our first quarter 2024 financial results and business updates. 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 Brockliff, our Chief Executive Officer, is here with me for the prepared portion of the call, and other members of our management team will be available for Q&A. With that, I'll turn the call over to Adrian. Ad?

Thanks, Judy. Thanks, everyone, for joining us for our Q1 call. I plan to provide Some brief comments before we go into Q&A. The comments are going to be brief because a couple of weeks ago we held an investor day, and we provided a fairly comprehensive update on the regulatory status of Afamacel as we move towards the PDUFA date of the 4th of August. And we also talked about how important this is for the field as the first approved engineered TCR T-cell therapy for a solid tumor indication. We also discussed our preparations for the commercial launch of Afamacel in some detail. We said that we'd be ready to do this on approval of Afamacel and that this would be the beginning of a commercial sarcoma franchise that we feel has significant and underappreciated value. In this morning's press release, we provided a further update on the BLA progress. And our head of late-stage development, Dennis Williams, is here for the Q&A portion of this call. In short, our interactions with the FDA are progressing as planned, and we're looking forward to our late-cycle review meeting in the second half of this month. Thus far, the FDA has not requested an ADCOM or a REMS program. We look forward to the labeling discussions and also to commercialization in due course. And I'm happy to confirm that our customer facing commercial and med affairs team are now fully in place. Cynthia Pacina, our chief commercial officer, is here for the Q&A as well. As I said, we are on track to be ready to launch on approval. We have a focused team starting at six to 10 treatment centers and ramping up to approximately 30 in due course. And if you revisit the Investor Day presentation by Dr. Mihaela Druta, which is available on our website, you will see that the expectations and anticipation for a famicel within the sarcoma community are very high. I think that sense of anticipation was reinforced by Philip Leder, patient advocate and president of the Sarcoma Alliance, who lost his sister to sarcoma. And he, I think, very eloquently highlighted the demand for novel therapies in this space. So we are scaling our manufacturing to be able to meet what we anticipate to be the launch volumes for Afamacel in the second half of 2024. And in summary, all is on track for the launch of Afamacel on approval. And that's expected around our PDUFA date in August and is highly anticipated by the sarcoma community. And obviously, we are very eager to get this product into the hands of this community that has worked so hard with us over the last decade to develop medicines for sarcoma. Behind the Famicel, we are also progressing the development of Leticel, and I'll point you towards a presentation of the interim data analysis from the pivotal IGNI ESO trial in synovial sarcoma and MR-CLS that we previewed at a high level last year. These data look very similar to a famicel, other than, of course, they are in both synovial sarcoma and myxoid rounds of liposarcoma, and will be presented at a platform presentation at ASCO by Dr. Sandra DeAngelo. This will be an important milestone for people's understanding and the de-risking of this cell therapy as we continue to move towards having a BLA in place in 2025 with anticipated approval for Leticel in synovial sarcoma and MR-CLS in 2026. You'll have seen another press release from us this morning announcing that we've secured up to $125 million in debt financing with Hercules Capital, with the first tranche of $25 million available on closing and an additional $25 million available on Famicel approval. In addition, you will have seen that in Q1, we raised approximately $30 million off the ATM based on significant inbound inquiries. We've taken these steps to secure our financial position and have cash runway into late 2025. And with this runway, we have the funds necessary to execute on our priorities. The launch of Afamacel, followed by Leticel, and also executing on the other pipeline projects, such as the Phase II trial with user cell for platinum-resistant ovarian cancer. And Gavin Wood, our chief financial officer, is here for the Q&A as well. So with that, I'd like to turn it over to the operator for questions. Operator?