Financial Data and Key Metrics Changes - The company reported net sales of $4 million for Q1 2025, with a revenue guidance for the full year of $35 million to $45 million from T Cellra sales [4][5][50] - The average turnaround time from apheresis to release was 27 days, beating the target of 30 days [6] - The company achieved a 100% manufacturing success rate from its U.S. T Cell manufacturing center [6][31] Business Line Data and Key Metrics Changes - A total of 21 patients have been treated with T Cellra in 2025, with 13 in Q1 and 8 in early Q2 [4] - The company invoiced 14 T Cellra treatments in 2025 to date, with 6 in Q1 [5] - The company expects to have approximately 30 authorized treatment centers (ATCs) operational by the end of 2025, which is a year earlier than initially anticipated [4][5] Market Data and Key Metrics Changes - The company has seen effective patient access to T Cellra with no patient denials to date [6] - The annual incidence rate for eligible patients diagnosed with synovial sarcoma is approximately 1,000, which aligns with the company's expectations [68] Company Strategy and Development Direction - The company is focused on the successful launch of T Cellra and is preparing for the launch of Letocell, anticipated in 2026 [8] - The company is reviewing strategic options with Cowen as advisors to explore opportunities that benefit patients and shareholders [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the revenue guidance based on the number of patients treated and the operational efficiency of ATCs [50] - The company has had three formal meetings with the FDA in the last six months, indicating a positive regulatory environment [28] Other Important Information - The company has implemented cost reduction actions and a restructuring plan that impacted Q1 spending [46] - The gross margin in Q1 was around 78%, with expectations of normalizing to about 70% in the long run [66] Q&A Session Summary Question: Clarification on apheresis patients invoiced - Management confirmed that most apheresis patients invoiced in Q1 were from the prior quarter, with expectations for invoicing the majority in the coming month [10][11] Question: Trends in patient referrals and screening - Management expects incremental growth quarter on quarter without specific seasonalization, driven by increased awareness and onboarding of ATCs [16][18] Question: Impact of regulatory changes - Management noted that the FDA remains engaged and has not indicated any issues with the regulatory process [28] Question: Key learnings from the early launch - The onboarding of treatment centers has occurred faster than anticipated, and the manufacturing success rate has been exceptional [29][31] Question: Financing and liquidity concerns - The company paid down $25 million of financing obligations to manage its balance sheet and leverage [42][45] - The company has less than twelve months of cash runway, and detailed cash guidance was deemed inappropriate due to various influencing factors [46][47]

Financial Data and Key Metrics Changes - The company reported net sales of $4 million for Q1 2025, with a revenue guidance for the full year of $35 million to $45 million from TESELRA sales [3][4][5] - The average turnaround time from apheresis to release was 27 days, beating the target of 30 days [5] - The company achieved a 100% manufacturing success rate from its U.S. T Cellular manufacturing center [5][6] Business Line Data and Key Metrics Changes - A total of 21 patients have been treated with TESELRA in 2025, with 13 in Q1 and 8 in early Q2 [3][4] - The company invoiced 14 T Cellular treatments in 2025 to date, with 6 in Q1 [4] - The company anticipates peak sales of $400 million from its combined T Cellra and Letocell sarcoma franchise [5] Market Data and Key Metrics Changes - The company has established 28 authorized treatment centers (ATCs) for TESELRA, with plans to reach approximately 30 by the end of 2025 [3][4] - The company expects to treat around 1,000 patients annually diagnosed with synovial sarcoma, aligning with initial forecasts [67][68] Company Strategy and Development Direction - The company is focused on the successful launch of TESELRA and preparing for the launch of Letocell, anticipated in 2026 [6] - Investments in infrastructure for T Cellra will also support the Letocell launch [6] - The company is exploring strategic options with Cowen as advisors to benefit patients and shareholders [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the revenue guidance based on patient treatment cycles and the number of treatment centers [3][5] - The management noted that the FDA is engaged and working diligently on regulatory matters, with no indications of delays [28] - The company has seen positive trends in patient referrals and screening, expecting incremental growth quarter over quarter [18][19] Other Important Information - The company has not experienced any patient denials to date, indicating effective patient access to TESELRA [5] - The company is managing its balance sheet and has paid down $25 million of financing obligations to improve leverage [44][45] Q&A Session Summary Question: Clarification on apheresis patients invoiced - Management indicated that most apheresis patients invoiced in Q1 were from the prior quarter, with expectations for invoicing to continue in the coming months [10] Question: Trends in patient referrals and screening - Management expects incremental growth quarter over quarter, driven by increased awareness and onboarding of ATCs [18] Question: Impact of regulatory changes - Management noted ongoing engagement with the FDA and no indications of delays in regulatory processes [28] Question: Key learnings from the early launch - Management highlighted faster-than-expected onboarding of treatment centers and a 100% manufacturing success rate as key positives [30][31] Question: Cash runway and sustainability of operations - Management acknowledged a substantial debt concern and indicated that cash runway guidance is inappropriate due to various impacting factors [45][46] Question: Drop-off rate from apheresis to infusion - Management confirmed that there have been no cancellations from the moment a patient is enrolled, indicating a high conversion rate [39] Question: Manufacturing maintenance plans - Management stated there are no significant maintenance plans that would impact capacity for the year [58] Question: COGS tracking and expectations - Management indicated that COGS for the first few quarters will be higher than expected due to pre-purchased products, with margins expected to normalize [63][66]