Core Insights - TScan Therapeutics has reached an agreement with the FDA on the pivotal trial design for TSC-101, which is expected to begin in Q2 2026 [3][4] - The company has decided to prioritize the clinical development of its heme program while pausing enrollment in the solid tumor Phase 1 trial [5][13] - Financial results for Q3 2025 show a revenue increase to $2.5 million, up from $1.0 million in Q3 2024, primarily due to research activities with Amgen [7] FDA Agreement and Clinical Development - The FDA has approved a pivotal trial design for TSC-101 that mirrors the ALLOHA Phase 1 trial, utilizing a biologically-assigned internal control arm [3] - The pivotal trial is anticipated to facilitate efficient enrollment and streamlined assessment of study endpoints [3] - The company has implemented a commercial-ready manufacturing process that reduces manufacturing time by five days, lowering costs and the extent of ex vivo T cell expansion [3] Financial Performance - Revenue for Q3 2025 was $2.5 million, a 150% increase from $1.0 million in Q3 2024 [7] - R&D expenses rose to $31.7 million in Q3 2025 from $26.3 million in Q3 2024, driven by increased manufacturing and clinical activities [8] - General and administrative expenses increased slightly to $7.9 million in Q3 2025 from $7.4 million in Q3 2024 [9] - The net loss for Q3 2025 was $35.7 million, compared to $29.9 million in Q3 2024 [10] Cash Position and Future Plans - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities of $184.5 million, expected to fund operations into the second half of 2027 [10] - Plans to submit IND applications for two additional TCR-T product candidates are set for Q4 2025 [13] - The company aims to share updated clinical data from the ALLOHA Phase 1 heme trial at the upcoming ASH Annual Meeting [4]