Adaptimmune(US:ADAP)2022-05-09 17:57Financial Data and Key Metrics Changes - The company reported total liquidity of $304 million at the end of Q1 2022, providing a cash runway extending into early 2024 [11][12] - The company has invested significantly over the last few years to build an integrated cell therapy company with a full range of end-to-end capabilities [11] Business Line Data and Key Metrics Changes - Progress is being made towards the submission of the Biologics License Application (BLA) for afami-cel for the treatment of synovial sarcoma [6][7] - The MAGE-A4 franchise is expanding with the SURPASS family of clinical trials, showing responses across a broad range of solid tumors [7][8] - The company is scaling U.S. manufacturing facilities and nearing completion of a dedicated allogeneic manufacturing facility in the U.K. [8][9] Market Data and Key Metrics Changes - The company is the only cell therapy company with late-stage autologous programs and advanced capabilities in the allogeneic space [8] - The management team is aware of challenges in the biotech and wider financial markets but believes fundamentally good companies will achieve fair valuation as markets rebalance [12] Company Strategy and Development Direction - The company is focused on a 2-2-5-2 strategy, with specific focus areas including filing the BLA for afami-cel, building the MAGE-A4 franchise, scaling manufacturing capabilities, and progressing allogeneic products towards the clinic [6][7] - The company aims to transform the lives of people with cancer through the discovery, development, and delivery of cell therapies [6][53] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to weather difficult markets and emphasized the importance of having a seasoned management team [12] - The company anticipates submitting the BLA by the end of the year and hopes to launch by the end of next year [45] Other Important Information - Jo Brewer has been appointed as Chief Scientific Officer, bringing over 20 years of experience in T-cell receptors and cell therapies [9] - The company is preparing for the launch of its first commercial product, focusing on centers of excellence due to the ultra-rare disease nature of its target market [45] Q&A Session Summary Question: Update on A2M4CD8 program at ESMO - The company is not providing guidance on the number of patients but will update on all patients at the time of the data cut for ESMO [15][16] Question: BLA submission timelines - The company has not had the pre-BLA meeting yet but remains on track for filing this year [18] Question: Rationale for next-generation major core product with IL-7 and CCL19 - The rationale involves increasing T-cell proliferation and trafficking to the tumor site, with ongoing evaluations for both hot and cold tumors [20] Question: Vector manufacturing and Miltenyi - Miltenyi Biotec is the supplier for the vector for afami-cel, while the company is also building its own vector manufacturing facility [22][23] Question: SURPASS-3 trial initiation steps - Steps include seeking KOL advice, finalizing the protocol, and preparing for regulatory submissions, with the study on track to initiate this year [29] Question: Potency assays and FDA alignment - The company is validating the same potency assay used in the clinic and is confident in completing that validation [34] Question: ASCO data update for afami-cel - The update will combine data from the Phase 1 and Phase 2 studies, providing a larger dataset for analysis [36] Question: IL-7 levels and TIL quality measurement - The company can measure IL-7 in patients, with a focus on IL-7 production triggered by T-cell activity within the tumor [40] Question: Pre-BLA meeting and launch preparation - The pre-BLA meeting is expected to happen a few months ahead of the filing, with updates to follow [42][43] Question: Genentech program target identification - Initial targets have been selected, and the collaboration is moving forward as planned [50]