Syndax(US:SNDX)2024-11-05 21:02Financial Performance - Syndax reported a net loss of $84.1 million, or $0.98 per share, for Q3 2024, compared to a net loss of $51.1 million, or $0.73 per share, in the same period last year[14]. - Total operating expenses for the three months ended September 30, 2024, were $102.1 million, up from $56.4 million in the same period last year, representing an increase of 81.2%[25]. - The net loss for the three months ended September 30, 2024, was $84.1 million, compared to a net loss of $51.1 million for the same period in 2023, reflecting a year-over-year increase of 64.5%[25]. - Research and development expenses for the three months ended September 30, 2024, were $71.0 million, a 81.6% increase from $39.1 million in the same period last year[25]. Expenses - Research and development expenses increased to $71.0 million in Q3 2024 from $39.1 million in the prior year, primarily due to higher clinical development and pre-commercial manufacturing costs[12]. - Selling, general and administrative expenses rose to $31.1 million in Q3 2024, up from $17.3 million in the prior year, driven by increased commercial readiness activities for revumenib and axatilimab[13]. - The company expects full-year 2024 research and development expenses to be between $245 million and $250 million, and total operating expenses to be between $365 million and $370 million[15]. Cash and Assets - As of September 30, 2024, Syndax had cash, cash equivalents, and investments totaling $399.6 million[11]. - Syndax's total assets decreased from $612.9 million on December 31, 2023, to $425.8 million on September 30, 2024, a decline of 30.5%[24]. - Total stockholders' equity decreased from $554.2 million on December 31, 2023, to $366.4 million on September 30, 2024, a decrease of 33.8%[24]. Product Development and Approvals - Revumenib's New Drug Application (NDA) is under Priority Review with a PDUFA action date set for December 26, 2024[3]. - Topline data from the AUGMENT-101 trial for R/R mNPM1 AML is expected in Q4 2024, with a potential supplemental NDA filing in the first half of 2025[4]. - Niktimvo received FDA approval for chronic GVHD treatment and is anticipated to launch in the U.S. by early Q1 2025[9]. - Niktimvo (axatilimab-csfr) is approved in the U.S. for chronic graft-versus-host disease (GVHD) after failure of at least two prior systemic therapies[20]. - The company plans to initiate a pivotal trial of revumenib in combination with venetoclax and azacitidine by year-end 2024[8]. - The company has ongoing clinical trials for axatilimab, including a Phase 2 trial in chronic GVHD and a Phase 2 trial in idiopathic pulmonary fibrosis[20]. Revenue - Syndax reported milestone and license revenue of $12.5 million for the three months ended September 30, 2024, compared to $0 for the same period in 2023[25]. Stock Information - Syndax's common stock outstanding increased from 84,826,632 shares to 85,285,488 shares from December 31, 2023, to September 30, 2024[24]. - The weighted-average number of common stock used to compute net loss per share increased from 69,645,888 to 85,433,569 shares year-over-year[25].