Alaunos Therapeutics(TCRT) - 2021 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended the first half of 2021 with approximately $76.7 million in cash and announced a venture debt facility with Silicon Valley Bank for $50 million, with an immediate drawdown of $25 million, extending the cash runway into the fourth quarter of 2022 [10][11][12] Business Line Data and Key Metrics Changes - The company achieved key milestones in its TCR-T program, including the commissioning of a cGMP clinical production unit and completion of aseptic process validation, enabling the facility to be used for the Phase 1/2 TCR-T library trial [8][14] - The Phase 1/2 trial is targeting six solid tumor indications, including cholangiocarcinoma, pancreatic, ovarian, endometrial, colorectal, and lung cancer, with plans to expand the indications in the future [15][21] Market Data and Key Metrics Changes - The company is focused on establishing in-house cGMP clinical production capabilities to provide greater flexibility and control over clinical development, which is expected to mitigate risks and increase capacity for clinical trial activities [18][19] Company Strategy and Development Direction - The company is directing all efforts towards the TCR program and remains optimistic about its potential, emphasizing that success will depend on scientific and clinical data rather than operational challenges [9][12] - The company is also considering broader partnerships for the development of its CD19 RPM CAR-T cell therapy, with several parties expressing interest [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position and progress, stating that the current market valuation does not reflect the company's potential and that continued execution is the best way to demonstrate its value [11][12] - The search for a permanent CEO is nearing completion, with an announcement expected soon [13] Other Important Information - The company plans to provide updates on its TCR-T library later in the year and has shared preclinical data that supports the efficacy of its TCR program [20][25] Q&A Session Summary Question: Can you discuss the current manufacturing process in Taiwan and any leverage from TCR-T experience? - The manufacturing process in Taiwan utilizes a rapid personalized manufacturing process (RPM) with Sleeping Beauty for genetic transfer, performed by the TriArm team at a cGMP facility [27][30] - Insights gained from the TCR process may help improve the CAR-T process, as the TCR process is more mature and has had more years of development [32]