Alaunos Therapeutics(US:TCRT)2021-11-09 00:45Financial Data and Key Metrics Changes - For Q3 2021, the company reported a net loss of approximately $22.7 million, or $0.11 net loss per share, compared to a net loss of approximately $20.3 million, or $0.10 net loss per share for Q3 2020, indicating a year-over-year increase in net loss [13] - Research and development expenses totaled approximately $14.5 million for Q3 2021, an increase of 4% from approximately $14 million for the same period in 2020 [13] - General and administrative expenses were approximately $8.2 million for Q3 2021, compared to approximately $6.4 million for Q3 2020 [13] - Total operating expenses for Q3 2021 were approximately $22.7 million, an increase of 12% compared to approximately $20.3 million for the same period in 2020 [14] - Cash and cash equivalents as of September 30, 2021, were approximately $91.7 million, with an anticipated cash runway extending into the second quarter of 2023 [14][15] Business Line Data and Key Metrics Changes - The company is focusing on advancing its differentiated TCR-T cell platform and has made significant progress in operationalizing its in-house CGMP clinical production unit [5][6] - The TCR-T library trial is set to evaluate patients across six solid tumor indications, including lung, colorectal, endometrial, pancreatic, ovarian, and bile duct cancers [10] Market Data and Key Metrics Changes - The company has opened its screening study at the MD Anderson Cancer Center and is actively screening patients for the Phase 1/2 treatment study [10] Company Strategy and Development Direction - The company has strategically restructured to focus on generating clinical data and advancing its TCR-T platform [4] - The TCR-T library platform is enabled by non-viral Sleeping Beauty technology, allowing the company to target multiple solid tumor indications within a single trial, which is critical for its go-forward strategy [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the internal capabilities to advance scientific research into clinical applications and emphasized the importance of generating clinical data [5][15] - The company aims to begin treating patients in the first half of 2022 and is focused on executing its strategic priorities to bring value to stakeholders [15] Other Important Information - The company has developed an innovative platform with internal resources, including genomics, bioinformatics, and cellular immunology, to generate and validate TCR-T targets exclusively owned by the company [12] Q&A Session Summary Question: What are the gating factors to starting the Phase 1/2 study? - Management indicated that the all-clear on the IND from the FDA is crucial, along with screening and enrolling patients [18] Question: What is the plan for operating expenses following the restructuring? - Management anticipates cash burn to be less than $15 million per quarter moving forward [18] Question: What needs to be completed before dosing the first patient in the TCR-T trial? - Management reiterated that they are waiting for FDA review and are actively screening patients [23] Question: What are the plans for commercial manufacturing? - Management stated that commercial manufacturing is several years away and no strategy has been communicated yet [25] Question: Have there been any retention strategies for staff after restructuring? - Management confirmed that incentive stock options were granted to retain staff, and there have been no unexpected resignations [31] Question: Will new TCRs be added to the IND prior to clearance? - Management indicated that adding new TCRs will be an ongoing process, not linked to the IND submission timeline [33]