Syndax(US:SNDX)2025-05-05 20:02Financial Performance - Syndax reported $20.0 million in net revenue from Revuforj in the first quarter of 2025, marking the first full quarter of its U.S. launch[5] - Niktimvo generated $13.6 million in net revenue in its first partial quarter of launch, with Syndax recording a $0.2 million share of the net commercial loss[10] - Product revenue for the first quarter of 2025 was $20,042,000, compared to $0 in the same period of 2024[34] - Net loss for Q1 2025 was $84,846,000, compared to a net loss of $72,400,000 in Q1 2024, indicating a 17.2% increase in losses[34] - Basic loss per share attributable to common stockholders was $0.98 in Q1 2025, compared to $0.85 in Q1 2024, reflecting a 15.3% increase[34] Expenses - Research and development expenses increased to $61.6 million in Q1 2025, up from $56.5 million in the same period last year, primarily due to axatilimab-related costs[12] - Selling, general and administrative expenses rose to $41.0 million in Q1 2025, compared to $23.0 million in the prior year, driven by increased employee-related expenses[13] - The company expects R&D expenses for Q2 2025 to be between $70 million and $75 million, with total expenses (R&D plus SG&A) projected at $110 million to $115 million[15] - Total operating expenses increased to $103,799,000 in Q1 2025, up from $79,514,000 in Q1 2024, representing a 30.5% increase[34] - Research and development expenses rose to $61,636,000 in Q1 2025, compared to $56,492,000 in Q1 2024, marking an increase of 9.5%[34] - Selling, general and administrative expenses increased significantly to $41,031,000 in Q1 2025 from $23,022,000 in Q1 2024, a rise of 78.3%[34] Cash and Assets - The company had cash, cash equivalents, and investments totaling $602.1 million as of March 31, 2025, expected to fund operations to profitability[9] - Cash, cash equivalents, and investments decreased to $602,135,000 as of March 31, 2025, down from $692,404,000 as of December 31, 2024, a decline of 13.0%[32] - Total assets decreased to $640,707,000 as of March 31, 2025, compared to $724,816,000 as of December 31, 2024, a reduction of 11.6%[32] - Total stockholders' equity fell to $215,059,000 as of March 31, 2025, down from $288,124,000 as of December 31, 2024, a decrease of 25.3%[32] - Common stock outstanding increased to 86,047,032 shares as of March 31, 2025, compared to 85,694,443 shares as of December 31, 2024[32] Product Development and Market Opportunities - Syndax plans to initiate multiple trials of revumenib in combination with standard care regimens for newly diagnosed acute leukemia patients starting in the second half of 2025[8] - The company submitted a supplemental New Drug Application (sNDA) for revumenib for the treatment of R/R mNPM1 AML in April 2025, seeking Priority Review[5] - Revuforj and Niktimvo are positioned to unlock multi-billion-dollar opportunities in their respective markets, supported by strong clinical data and ongoing trials[3]