Core Insights - The company has reached a positive agreement with the FDA on the pivotal study design for TSC-101, focusing on hematologic malignancies such as AML and MDS [3][5] - A strategic prioritization has led to a workforce reduction of approximately 30%, or 66 employees, to concentrate on the heme program and preclinical development for solid tumors [3][8] - The company expects to extend its cash runway into the second half of 2027, with anticipated annual cost savings of approximately $45 million in 2026 and 2027 [4][11] Hematologic Malignancies Program - The pivotal trial for TSC-101 will mirror the ongoing Phase 1 ALLOHA trial, utilizing a biologically assigned internal control arm to support relapse-free survival as the primary endpoint [3][5] - The company has developed a commercial-ready manufacturing process that shortens manufacturing time by five days, resulting in lower costs and reduced T cell expansion needs [4][9] - Plans to submit IND applications for two additional TCR-T product candidates are scheduled for Q4 2025, aiming to initiate Phase 1 development in H2 2026 [6][16] Solid Tumor Program - The company has dosed its first two patients with multiplex TCR-T therapy in the PLEXI-T trial but has paused further enrollment to focus on preclinical development of in vivo-engineered TCR-Ts for solid tumors [10] - Initial safety and efficacy data from the PLEXI-T trial is expected to be shared in Q1 2026 [10] Autoimmunity - The company continues to identify novel targets in autoimmune diseases, including ankylosing spondylitis and ulcerative colitis, and is collaborating with Amgen for Crohn's disease target discovery [10] Financial Updates - The company anticipates a one-time charge of up to approximately $2.3 million in Q4 2025 for severance-related benefits and other costs due to the workforce reduction [11] - The strategic prioritization is expected to preserve capital while enhancing shareholder value [4][8]