- In May 2016, received from the U.S. Food and Drug Administration (FDA), Fast Track designation for AXS-02 for the pain of knee osteoarthritis (OA) associated with bone marrow lesions (BMLs).
- In April 2016, received from the FDA, Pre-Investigational New Drug Application (Pre-IND) written guidance on AXS-05 for agitation in patients with Alzheimer's disease (AD).
- In March 2016, enrolled the first patient in the COAST-1 (Clinical Knee Osteoarthritis Symptom Treatment 1) study, a Phase 3 trial evaluating the efficacy and safety of AXS-02 for the pain of knee OA associated with BMLs.
- In March 2016, enrolled the first patient in the STRIDE-1 (Symptom Treatment in Resistant Depression 1) study, a Phase 3 trial evaluating the efficacy and safety of AXS-05 for treatment resistant depression (TRD).
- Research and development (R&D) expenses: R&D expenses were $4.5 million for the quarter ended March 31, 2016 compared to $1.4 million for the comparable period in 2015. The increase in R&D expenses was primarily due to increased clinical trial expenses related to our CREATE-1, STRIDE-1, and COAST-1 studies, as well as an increase in personnel costs and stock compensation expense in 2016.
- General and administrative (G&A) expenses: G&A expenses were $1.4 million for the quarter ended March 31, 2016 compared to $0.5 million for the comparable period in 2015. The increase in G&A expenses was primarily due to fees incurred to support operating as a public company.
- Net loss: Net loss was $5.9 million, or $(0.31) per share for the quarter ended March 31, 2016, compared to a net loss of $2.1 million, or $(0.19) per share for the quarter ended March 31, 2015.
- Cash: As of March 31, 2016, Axsome had $44.1 million of cash compared to $48.0 million of cash as of December 31, 2015. Axsome currently anticipates that its cash will be sufficient to fund its anticipated operations into the third quarter of 2017.
- Shares outstanding: At March 31, 2016, Axsome had 19,149,417 shares of common stock outstanding.
|Axsome Therapeutics, Inc.|
|Selected Consolidated Financial Data|
|Statements of Operations Information (unaudited):|
|Three Months Ended March 31,|
|Research and development||$||4,526,252||$||1,416,283|
|General and administrative||1,356,613||516,840|
|Total operating expenses||5,882,865||1,933,123|
|Loss from operations||(5,882,865||)||(1,933,123||)|
|Interest and amortization of debt discount/premium income (expense)||16,924||(128,781||)|
|Change in fair value of warrant liability||—||870|
|Change in fair value of embedded derivative liabilities||—||(79,100||)|
|Net loss per common share - basic and diluted||$||(0.31||)||$||(0.19||)|
|Weighted average common shares outstanding - basic and diluted||19,149,417||11,108,144|
|Balance Sheet Information:|
|March 31, 2016||December 31, 2015*|
|*Condensed from audited financial statements.|