Adaptimmune Therapeutics plc

Good day and welcome to the Adapt Immune second quarter 2024 conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on a touch-tone phone. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Dan Odd-Cohen, Investor Relations. Please go ahead.

Thank you, operator. Good morning and welcome to Adaptoons conference call to discuss our second quarter 2024 financial results and business updates. I would ask you to review the full text or 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. Adrienne 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 Adrienne Rockliffe.

Thanks, Dan, and thanks, everyone, for joining us. We are incredibly proud that Adaptimmune is now a commercial-stage cell therapy company, following the US FDA approval and the launch of our first product in our sarcoma franchise, T-Cellra. This is a fantastic achievement for the company, for the cell therapy field, and for people with synovial sarcoma. T-cell rot is the first engineered cell therapy for a solid tumor, the first medicine in its class. And it's also the first new treatment option for synovial sarcoma in over a decade. And the culmination of groundbreaking R&D, our investment in manufacturing, the demonstrable clinical benefit exhibited throughout development, and incredible execution of the regulatory process. T-cell rot is a vindication of autologous cell therapy for solid tumor cancers. And together with the synovial sarcoma community, we're going to redefine how synovial sarcoma is treated. Launch activities for T-Celera started the instant we received approval, and we hit the ground running. I want to provide some updates on how T-Celera's launch is going, bearing in mind that we're only 10 days in. As synovial sarcoma is a rare disease, treatment is concentrated in sarcoma centers of excellence. We've already recruited, trained, and deployed a commercial footprint to deliver T-SOA to people with sarcoma. Our commercial, med affairs, manufacturing, and supply teams are all in place and engaging patients, physicians, payers, and treatment centers. The companion diagnostics for HLA and MAGE A4 testing were approved concurrently with T-SOA. so healthcare providers can arrange for patients to get tested to establish their biomarker eligibility. Incidentally, we believe this is the first time that a therapy has been approved together with two new diagnostics at the same time. Adaptamine Assist, our patient support program, is up and running to ensure a personalized experience throughout the treatment journey. And we've previously discussed our plans to activate six to 10 authorized treatment centers during T-Cellular's launch periods. We're on track to do this. We have five ATCs available in our locator tool on tcellular.com website, and all of our internal systems are in place to accept orders and to manufacture and deliver T-Cellular. Over the next few courses, and prior to having trends for patients treated and for sales, we will be updating you on two key performance indicators for launch execution as we go forward. Firstly, the number of ATCs opened, and secondly, the number of patients apareased. As we move through the first half of next year, we will transition to patients treated and obviously to sales as the key metrics. Moving on to the positioning of adaptamune beyond the launch of T-Cellera, I want to touch a little on our balance sheet and our pipelines. At the end of Q1 this year, we had approximately $144 million in total liquidity and runway guidance into late 2025. During Q2, we signed a collaboration agreement with Galapagos and entered into a debt facility with Hercules. And at the end of the quarter, we have total liquidity of $215 million. We believe we are well capitalized to deliver the successful launch of T-SERA and also develop the rest of the pipeline. As we transition into a commercial cell therapy company, we will move away from extending cash runway guidance given the complexities of estimating future revenues in the near term as we establish our sarcoma franchise. And instead, we'll provide high-level forward cost guidance alongside regular updates on the commercialization progress. During the first half of this year, our total expenditure was approximately $114 million. This included investments preparing for the launch of TESORA, as well as hiring and onboarding the commercial team. For the next 18 months, we expect our run rate operating expenses to be broadly consistent with that of the first half of 2024. We'll update this cost guidance as we progress, together with the launch metrics that I previously articulated, namely the number of ATCs and the number of patient saferies. Moving on to our pipeline. We're progressing our clinical pipeline with the second product in our sarcoma franchise, Leticel, expanding the number of sarcoma patients we can treat with our cell therapies. Leticel is clinically de-risked as the pivotal trial, Ignidiso, has already met the primary endpoint for efficacy at the interim analysis. And this was presented earlier this year at ASCO by Dr. Sandra D'Angelo. Lettucelle's regulatory pathway will build on our experience with T-cells as regulatory submission. And as Lettucelle also targets soft tissue sarcomas, the commercial footprint is essentially identical to T-cells, and we expect significant channel synergies once we launch Lettucelle. We're also progressing user cell, our next generation cell therapy, in the surpassed three trial in ovarian cancer, which is currently enrolling. And we'll be moving forward in partnership with Galapagos in a head and neck cancer phase one trial with user cell on Galapagos' distributed manufacturing platform. We are an integrated cell therapy company built from the ground up to design, develop, and deliver cell therapy products to redefine the treatment of solid tumor cancers. And we are now realizing this vision in real time. And with that, myself and members of the leadership team are happy to take any questions. Operator?