Axsome Q1 2021 Earnings Report
Key Takeaways
Axsome Therapeutics reported a net loss of $29.3 million, or $(0.78) per share, for the quarter ended March 31, 2021. The company's R&D expenses were $16.6 million, and G&A expenses were $11.2 million. Axsome had $164.7 million in cash as of March 31, 2021, and believes it is sufficient to fund operations into at least 2024.
NDA for AXS-05 for the treatment of MDD was granted Priority Review by the FDA with a PDUFA target action date of August 22, 2021.
NDA for AXS-07 for the acute treatment of migraine is on track for submission to the FDA in the second quarter of 2021.
Phase 3 trial for AXS-12 for the treatment of narcolepsy is anticipated to be initiated mid-year.
Axsome is partnering with advocacy groups to raise awareness and support for people living with depression and other mental health conditions.
Axsome
Axsome
Forward Guidance
Axsome believes that its cash at March 31, 2021, along with the remaining committed capital from the $225 million term loan facility, is sufficient to fund anticipated operations into at least 2024. Axsome expects that its operating expenses will increase year over year as they continue to build out the commercial function and further advance their pipeline.