Talaris Therapeutics (TALS) Investor Presentation - Slideshow

FCR001 Therapy Overview - Talaris' FCR001 is a novel, single-dose, investigational cell therapy targeting solid organ transplantation and severe immune/non-malignant blood disorders[11, 63] - FCR001 aims to prevent organ rejection and the need for lifelong immunosuppression by reprogramming the recipient's immune system[8] - The therapy involves a proprietary composition of donor's CD34+ cells, Facilitating cells, and ab T-cells[17] Clinical Trial and Pipeline - FCR001 is in an open-label Phase 3 trial (FREEDOM-1) for living donor kidney transplant (LDKT) recipients, building on compelling Phase 2 data[11, 36] - Phase 2 study showed an 82% success rate (14 of last 17 patients) in weaning patients off immunosuppression after optimizing key parameters[13, 27] - Initial Phase 3 results are encouraging, with the first two patients off chronic immunosuppression with stable kidney function after 15 months follow up[11, 41] - Talaris is initiating two more Phase 2 studies in Q4 2021, including one for scleroderma (FREEDOM-3)[11, 49] - The company is also exploring FCR001's potential in deceased donor kidney transplant (DDKT), with a market opportunity of over 16,500 cases per year in the US[20, 45] Financial and Manufacturing - Talaris had approximately $255 million in cash on hand as of September 30, 2021[11, 63] - The company has a robust, reproducible, and fully in-house manufacturing process, with capacity to meet anticipated clinical needs[11, 21]