Axsome Therapeutics Reports First Quarter 2016 Financial Results
“We continued to make progress with our lead product candidates, AXS-02 and AXS-05, over the past quarter,” said
First Quarter and Recent Corporate Highlights
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).
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).
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.
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).
First Quarter 2016 Financial Results
- Research and development (R&D) expenses: R&D expenses were
$4.5 millionfor the quarter ended March 31, 2016compared to $1.4 millionfor 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 millionfor the quarter ended March 31, 2016compared to $0.5 millionfor 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 millionof cash compared to $48.0 millionof cash as of December 31, 2015. Axsome currently anticipates that its cash will be sufficient to fund its anticipated operations into the third quarter of 2017.
- Shares outstanding: At
March 31, 2016, Axsome had 19,149,417 shares of common stock outstanding.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation and completion of the trials; the timing of and our ability to obtain and maintain
|Axsome Therapeutics, Inc.|
|Selected Consolidated Financial Data|
|Statements of Operations Information (unaudited):|
|Three Months Ended March 31,
|Research and development||$||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.|
Mark JacobsonVice President, Operations Axsome Therapeutics, Inc. 25 Broadway, 9th Floor New York, NY10004 Tel: 212-332-3243 Email: email@example.com www.axsome.com