Syndax(US:SNDX)2021-03-09 21:47Pipeline and Clinical Trials - Syndax is developing SNDX-5613, a Menin Inhibitor Program, targeting acute leukemias, with Phase 1 data expected late in Q1 or early in Q2 and Phase 2 initiation expected in Q2[6, 8, 12] - AUGMENT-101 is a Phase 1/2 trial testing SNDX-5613 in MLL-r and NPM1 acute leukemia[10] - Axatilimab, an Anti-CSF-1R program, is in a global pivotal trial (AGAVE201) for chronic GVHD (cGVHD), with FPFV (First Patient First Visit) in Q4 2020 and topline results expected in 2023[7, 8, 21] - The AGAVE201 trial randomizes patients with recurrent or refractory active cGVHD after at least 2 lines of systemic therapy in a 1:1:1 ratio to receive Axatilimab at doses of 03 mg/kg Q2W (70 patients), 1 mg/kg Q2W (70 patients), or 3 mg/kg Q4W (70 patients)[19, 20] Financial Highlights - Syndax had $2931 million in cash and short-term investments as of December 31, 2020[23] - Shares outstanding as of December 31, 2020, were 514 million, including 479 million common shares and pre-funded warrants to purchase 36 million common shares[23] - Research and Development expenses for Q1 2021 are guided at $25-30 million, and for FY 2021 at $90-100 million[23] - Total Operating Expenses for Q1 2021 are guided at $30-35 million, and for FY 2021 at $110-120 million, including approximately $20 million non-cash stock compensation expense per quarter[23] Business Development - Business development is a core strength, with clinical development leadership enabling competitive advantage[22] - Axatilimab was acquired from UCB, and Menin-MLL inhibitors were acquired from Allergan/Vitae[22]