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Jun 30, 2024
Syndax Q2 2024 Earnings Report
Syndax reported financial results and provided a business update.
Key Takeaways
Syndax Pharmaceuticals reported its Q2 2024 financial results, highlighting the advancement of its pipeline and the upcoming PDUFA action dates for axatilimab and revumenib.
Axatilimab BLA in refractory chronic GVHD is under Priority Review with a PDUFA action date of August 28, 2024.
Revumenib NDA in R/R KMT2Ar acute leukemia is being reviewed under RTOR with a PDUFA action date of December 26, 2024.
Pivotal AUGMENT-101 topline data from the mNPM1 AML cohort is expected in 4Q24, with a potential sNDA filing in 1H25.
The Company expects research and development expenses to be $70 to $75 million and total operating expenses to be $105 to $110 million for the third quarter of 2024.
Syndax
Syndax
Forward Guidance
Syndax provided financial guidance for the third quarter and full year of 2024.
Positive Outlook
- The Company continues to believe it has sufficient capital to fund its research, clinical development and commercial operations through 2026.
Challenges Ahead
- For the third quarter of 2024, the Company expects research and development expenses to be $70 to $75 million.
- For the third quarter of 2024, the Company expects total operating expenses to be $105 to $110 million.
- For the full year of 2024, the Company continues to expect research and development expenses to be $240 to $260 million.
- For the full year of 2024, the Company continues to expect total operating expenses to be $355 to $375 million, which includes milestone payments that the Company expects to become due as well as an estimated $43 million in non-cash stock compensation expense.