Syndax Pharmaceuticals Reports Significant Revenue Growth, Increased Losses in Q3 2024

Syndax Pharmaceuticals, Inc. reported its financial results for the third quarter and the nine months ended September 30, 2024, highlighting significant changes in revenue, expenses, and overall financial health compared to the previous fiscal period.

For Q3 2024, Syndax generated total revenues of $12.5 million, primarily from a milestone payment related to the FDA approval of its product Niktimvo (axatilimab) for chronic graft-versus-host disease (cGVHD). This marks a notable increase from zero revenue in Q3 2023. However, the company continues to face substantial losses, reporting a net loss of $84.1 million for the quarter, up from a net loss of $51.1 million in the same period last year. The net loss per share attributable to common stockholders also increased to $(0.98) from $(0.73).

For the nine months ended September 30, 2024, total revenues were $12.5 million, compared to $3.5 million in the same period of 2023. The net loss for this period was $224.6 million, a significant increase from $136.9 million in the prior year. The net loss per share for the nine months was $(2.63), compared to $(1.97) in 2023.

Operating expenses surged, with research and development (R&D) expenses for Q3 2024 reaching $71.0 million, up from $39.1 million in Q3 2023. For the nine-month period, R&D expenses totaled $176.1 million, an increase of $68.2 million year-over-year. This rise is attributed to costs associated with clinical trials for revumenib and axatilimab, including milestone payments and pre-commercial activities.

Selling, general, and administrative (SG&A) expenses also increased significantly, totaling $31.1 million for Q3 2024, compared to $17.3 million in Q3 2023. For the nine months, SG&A expenses reached $83.2 million, up from $44.2 million in the prior year, driven by pre-commercialization activities and increased headcount.

As of September 30, 2024, Syndax's cash and cash equivalents stood at $133.0 million, a decrease from $295.4 million at the end of 2023. Total assets were reported at $425.8 million, down from $612.9 million at the end of the previous year. The company has an accumulated deficit of $1.1 billion and expects to continue incurring significant losses as it prepares for the launch of Niktimvo in early Q1 2025.

Strategically, Syndax entered a Royalty Agreement with Royalty Pharma in October 2024, granting Royalty Pharma a 13.8% royalty on quarterly net sales of Niktimvo, with an upfront payment of $350 million received in November 2024. The company is also advancing its pipeline, with revumenib under Priority Review by the FDA, targeting a PDUFA date of December 26, 2024.