Axsome Q4 2019 Earnings Report
Key Takeaways
Axsome Therapeutics reported a net loss of $24.8 million for Q4 2019, with increased R&D and G&A expenses due to ongoing clinical trials and commercial function build-out. The company's cash position significantly improved, ending the year with $220.0 million.
NDA filings for AXS-05 in MDD and AXS-07 in migraine are expected in Q4 2020.
Topline results for STRIDE-1 (AXS-05 in TRD) and INTERCEPT (AXS-07 in migraine) Phase 3 trials are expected in Q1 2020.
Topline results for ADVANCE Phase 2/3 trial of AXS-05 in Alzheimer’s disease agitation are anticipated in Q3 2020.
Phase 3 trials of AXS-12 in narcolepsy are anticipated to begin in 2020.
Axsome
Axsome
Forward Guidance
Axsome anticipates R&D expenses to decrease in subsequent quarters and believes its cash will be sufficient to fund operations for at least two years.
Positive Outlook
- NDA filing for AXS-05 in the treatment of MDD expected in 4Q 2020
- NDA filing for AXS-07 in the acute treatment of migraine expected in 4Q 2020
- Topline data from Phase 3 STRIDE-1 trial of AXS-05 in TRD expected in 1Q 2020
- Topline data from Phase 3 INTERCEPT trial of AXS-07 in migraine expected in 1Q 2020
- Topline data from Phase 2/3 ADVANCE-1 trial of AXS-05 in AD agitation expected in 3Q 2020