Syndax(SNDX) - 2024 Q1 - Quarterly Results

Financial Position - As of March 31, 2024, Syndax had cash, cash equivalents, and short and long-term investments totaling $522.0 million[7]. - The company believes it has sufficient cash runway to fund its operations through 2026[13]. Research and Development Expenses - Research and development expenses for Q1 2024 increased to $56.5 million, up from $34.1 million in the same period last year, reflecting a 65.0% increase[8]. - Research and development expenses increased to $56,492,000 in Q1 2024 from $34,054,000 in Q1 2023, representing a 66% increase[26]. - For Q2 2024, the company expects research and development expenses to be between $50 million and $55 million[12]. - The company anticipates full-year 2024 research and development expenses to be between $240 million and $260 million[12]. Operating Expenses - Selling, general and administrative expenses rose to $23.0 million in Q1 2024, compared to $12.0 million in the prior year, marking a 91.7% increase[9]. - Selling, general and administrative expenses rose to $23,022,000 in Q1 2024 compared to $11,961,000 in Q1 2023, marking a 92% increase[26]. - Total operating expenses for Q1 2024 were $79,514,000, up from $46,015,000 in Q1 2023, reflecting a 73% increase[26]. - The company expects total operating expenses to be between $80 million and $85 million for Q2 2024[12]. - Total operating expenses are projected to be between $355 million and $375 million for full-year 2024[12]. Net Loss - The net loss attributable to common stockholders for Q1 2024 was $72.4 million, or $0.85 per share, compared to a net loss of $41.1 million, or $0.59 per share, in the same period last year[11]. - The net loss for Q1 2024 was $72,400,000, compared to a net loss of $41,126,000 in Q1 2023, indicating a 76% increase in losses[26]. - Net loss per share attributable to common stockholders was $0.85 in Q1 2024, up from $0.59 in Q1 2023, representing a 44% increase[26]. Clinical Developments - The FDA granted Priority Review for the NDA filing of revumenib, with a PDUFA action date set for September 26, 2024[5]. - The BLA filing for axatilimab was also granted Priority Review, with a PDUFA action date of August 28, 2024[10]. - Enrollment in the AUGMENT-101 pivotal trial cohort was completed, with topline data expected in Q4 2024 to potentially support a supplemental NDA filing in H1 2025[5]. Other Income - Other income (expense), net for Q1 2024 was $7,114,000, compared to $4,889,000 in Q1 2023, showing a 45% increase[26].