Release Date: August 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Adaptimmune Therapeutics PLC (ADAP, Financial) has successfully launched Tecelra, the first engineered cell therapy for a solid tumor, marking a significant milestone for the company.
- The company has established a commercial footprint and support systems, including patient support programs and companion diagnostics, to ensure a smooth rollout of Tecelra.
- Adaptimmune Therapeutics PLC (ADAP) has a strong financial position with $215 million in total liquidity, providing a runway into late 2025.
- The company is progressing its clinical pipeline with lete-cel, which has already met its primary endpoint of efficacy in the pivotal IGNYTE-ESO trial.
- Adaptimmune Therapeutics PLC (ADAP) has entered into a collaboration agreement with Galapagos and a debt facility with Hercules, enhancing its financial and operational capabilities.
Negative Points
- The initial launch of Tecelra is in its early stages, with only five authorized treatment centers (ATCs) currently available, which may limit immediate patient access.
- The company does not have full visibility into real-time testing metrics for patient eligibility, which could impact the speed of patient onboarding and treatment.
- There is uncertainty regarding the exact timeline for broad payer coverage for Tecelra, particularly for commercial patients, which could affect revenue generation.
- The absence of MRCLS on the Tecelra label may limit its market potential, although lete-cel is expected to address this gap in the future.
- The company anticipates consistent operating expenses over the next 18 months, which could strain financial resources if revenue generation does not meet expectations.
Q & A Highlights
Q: Are you seeing patients flow through the website for Tecelra, and what are the new sources of patient referrals?
A: We are seeing enthusiasm from treatment centers and other sarcoma centers of excellence. Patients have started the testing journey to identify eligibility for Tecelra, with most new referrals coming from other sarcoma centers across the country. - Cintia Piccina, Chief Commercial Officer
Q: How does the first version of ADP-600 stand out within the frame targeting space, and will it incorporate next-generation enhancements?
A: We are evaluating next-gen approaches with ADP-600 and will update on firm plans in the future. - Joanna Brewer, Chief Scientific Officer
Q: Can you speak to the proportion of synovial sarcoma patients seen at the five active ATCs and the onboarding timeline for additional sites?
A: The five active sites represent about 80% of patients in sarcoma centers of excellence. We plan to onboard about 30 ATCs, covering 50-70% of all synovial sarcoma patients. - Cintia Piccina, Chief Commercial Officer
Q: What are the gating steps for the BLA submission for lete-cel, and will there be additional data before filing?
A: The regulatory pathway for lete-cel follows the same as Tecelra. We will present primary data from the IGNYTE-ESO trial later this year. - Dennis Williams, SVP of Late Stage Development
Q: What was the rationale behind not pursuing MRCLS on the Tecelra label, and where will lete-cel be manufactured?
A: The decision was due to limited patient numbers in the trial. Lete-cel will initially be manufactured in Germany, with plans to add a US site in the future. - Dennis Williams, SVP of Late Stage Development and John Lunger, Chief Patient Supply Officer
Q: Can you provide the timeline from patient screening to infusion for Tecelra, and when do you expect broad payer coverage?
A: The process takes about 30 days from apheresis to infusion. Medicare coverage is already available, and commercial coverage will follow a similar pattern to CAR-Ts. - Cintia Piccina, Chief Commercial Officer
Q: What is the anticipated timeline for the interim analysis in the SURPASS-3 study?
A: The first interim analysis will occur after 13 patients are dosed in each arm. Full enrollment is expected next year, and data will be disclosed after the study is completed. - Elliot Norry, Chief Medical Officer
Q: Can you provide color on the underlying drivers behind the $400 million peak sales estimate for Tecelra and lete-cel?
A: The estimate is based on eligibility rates for HLA-A2 and MAGE-A4/NY-ESO expression, with similar access and manufacturing success rates as seen in clinical trials. - Cintia Piccina, Chief Commercial Officer
Q: Does your expense guidance include R&D funding from Galapagos, and what is the timeline for starting the proof-of-concept trial?
A: The expense guidance does not include offsetting revenue sources. We aim to start the head and neck cancer trial with Galapagos as soon as possible. - Adrian Rawcliffe, Chief Executive Officer
Q: What is the onboarding progress for the sarcoma centers of excellence as a referral network for Tecelra?
A: Our field teams are actively engaging with both current and future ATCs and sarcoma centers of excellence to educate on biomarkers and referral processes. - Cintia Piccina, Chief Commercial Officer
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
