Syndax(US:SNDX)2021-11-16 08:54Pipeline Programs - Syndax's pipeline focuses on Menin Inhibitor Program (SNDX-5613) and Anti–CSF-1R Program (Axatilimab) targeting indications with significant unmet needs[5, 6, 7] - AUGMENT-101 trials are underway in NPM1 mut AML, MLLr ALL and MLLr AML, each enrolling 64 adults + up to 10 peds, using a dose of 163mg BID with any strong CYP3A4 inhibitor[9, 10] - ASH abstract data (June 2021 cut) for AUGMENT-101 showed a CRc (CR+CRh+CRp+CRi/MLFS) of 44% (20/45) and a CRc MRD- rate of 70% (14/20)[18] - Axatilimab's ASH abstract (June 2021 data cut) reported an Overall Response Rate of 66% (25/38) across all doses and 75% (18/24) at the 1 mg/kg q2wk dose[29] SNDX-5613 Expansion - Trials testing expanded opportunities for SNDX-5613 to initiate in 1H22, including BEAT-AML (Frontline Ven/Aza combo), AUGMENT-102 (R/R Chemo combo), and INTERCEPT (MRD-progression in AML)[20] - SNDX-5613 aims to expand market potential by moving into frontline treatment, targeting additional patients and increasing treatment duration[23] Axatilimab Collaboration - Syndax and Incyte have a global collaboration for axatilimab development, with Syndax funding 45% of global trials and Incyte funding 100% of regional trials[25] - The collaboration includes $117 million upfront, $35 million equity at a 30% premium, up to $450 million in additional milestones, and a 50:50 profit split[25] Financial Status - As of September 30, 2021, Syndax had $229.7 million in cash and short-term investments and 52.2 million shares outstanding[38] - The company's FY 2021 operating expense guidance includes $90-100 million for Research and Development and $110-120 million for Total Operating Expenses[39]