Adaptimmune Therapeutics plc (NASDAQ:ADAP) Q2 2023 Results Conference Call August 9, 2023 8:00 AM ET
Company Participants
Juli Miller - Investor Relations
Adrian Rawcliffe - Chief Executive Officer
Dennis Williams - Senior Vice President, Late Stage Development
Elliot Norry - Chief Medical Officer
Gavin Wood - Chief Financial Officer
Conference Call Participants
Tony Butler - EF Hutton
Marc Frahm - TD Cowen
Jonathan Chang - Leerink Partners
Mara Goldstein - Mizuho
Operator
Good morning, ladies and gentlemen and welcome to Adaptimmune’s Q2 Financial and Business Update Conference Call. I would now like to turn the meeting call over to Ms. Juli Miller. Please go ahead, Ms. Miller.
Juli Miller
Good morning, and welcome to Adaptimmune’s conference call to discuss our second quarter 2023 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 Rawcliffe, our Chief Executive Officer, is here with me for the prepared portion of the call. Other members of our management team will be available for Q&A.
With that, I will turn it over to Adrian Rawcliffe. Ad.
Adrian Rawcliffe
Thank you, Julie, and thanks everyone for joining us. In this morning’s press release, we confirm data and catalysts that we anticipate over the next 18-months. For the next few minutes, I want to highlight achievements from this past quarter with a particular focus on our top priority, the afami-cel BLA.
Over the course of this year, Adaptimmune has made substantial progress towards filing BLA for afami-cel for people with synovial sarcoma. When approved, this will be the first commercially available engineered T-cell therapy for a solid tumor indication.
We have already completed submission of the preclinical and clinical modules, and we have been working towards submission of the final CMC portion of this rolling BLA submission. We have made significant progress with the CMC module, and its requirements, and we have taken full advantage of the opportunities for interaction with the FDA afforded by our RMAT designation.
In recent months, we have had two type B interactions with the agency to derisk key areas of the file. The first was to gain alignment with the agency that the confirmatory evidence requirements to convert this file from accelerated approval to full approval would be met with data from Cohort 2 of the SPEARHEAD-1 trial.