Syndax(US:SNDX)2025-11-03 21:04Financial Performance - Revuforj achieved $32.0 million in net revenue in Q3 2025, a 12% increase from Q2 2025, with approximately 850 prescriptions, a 25% increase from the previous quarter [83]. - Niktimvo generated $45.8 million in net revenue in Q3 2025, representing a 27% increase over Q2 2025, with the company's share of collaboration revenue at $13.9 million [87]. - For the nine months ended September 30, 2025, the company reported a net loss of $217.4 million, compared to a net loss of $224.6 million for the same period in 2024 [82]. - Total revenues increased to $45.9 million for the three months and $103.6 million for the nine months ended September 30, 2025, compared to $12.5 million and $16.0 million in the prior year [104]. - Net loss for the three months ended September 30, 2025, was $60.7 million, compared to a net loss of $84.1 million in the prior year [104]. Cash and Investments - As of September 30, 2025, the company had an accumulated deficit of $1.4 billion and cash, cash equivalents, and investments totaling $456.1 million [82]. - The company has cash and cash equivalents of $116.8 million and short and long-term investments totaling $339.3 million as of September 30, 2025 [134]. - Net cash used in operating activities increased to $253.5 million for the nine months ended September 30, 2025, from $217.5 million in the prior year [117]. - Net cash provided by investing activities was $208.5 million for the nine months ended September 30, 2025, compared to $49.2 million in the prior year [118][119]. - The company entered into a sales agreement for an At-the-Market Offering Program with the potential to raise up to $200 million, with $157.9 million available as of September 30, 2025 [131]. Expenses - Total operating expenses were $103.3 million for the three months and $314.2 million for the nine months ended September 30, 2025, an increase of $1.2 million and $54.9 million, respectively, from the prior year [104]. - Research and development expenses are expected to grow as the company continues to focus on advancing its clinical development programs [92]. - Selling, general and administrative expenses increased by $13.8 million for the three months and $46.6 million for the nine months ended September 30, 2025, primarily due to commercial-related costs [110]. - Research and development expenses decreased by $14.7 million for the three months ended September 30, 2025, but increased by $4.0 million for the nine months compared to the prior year [109][110]. Regulatory and Development Updates - Revuforj received FDA approval on October 24, 2025, for treating R/R AML with a susceptible NPM1 mutation, making it the first FDA-approved therapy for both R/R AML with an NPM1 mutation and R/R acute leukemia with a KMT2A translocation [83]. - Ongoing trials for revumenib include pivotal Phase 3 and Phase 1/2 studies evaluating its efficacy in various acute leukemia subtypes [83][84]. - Axatilimab is in development for newly diagnosed cGVHD patients and idiopathic pulmonary fibrosis, with ongoing trials expected to complete enrollment by the end of 2025 [87]. Future Outlook and Risks - The company anticipates stable selling, general, and administrative expenses in the coming years as it supports the commercialization of Revuforj and Niktimvo [96]. - The company expects to support future cash needs through equity offerings, debt financings, and collaboration arrangements, with no committed external source of liquidity [125]. - The company is subject to risks including unfavorable interest rates and geopolitical unrest, which could impact operations and financing [132]. - The company faces challenges in obtaining regulatory approvals and protecting intellectual property rights, which are common risks in the pharmaceutical industry [133].