Axsome Therapeutics Reports Second Quarter 2016 Financial Results
“In the second quarter we continued to advance our three ongoing Phase 3 trials, and we expanded our late-stage pipeline with the receipt of positive
Second Quarter Highlights
- Received Pre-Investigational New Drug Application (Pre-IND) written guidance from the
U.S. Food and Drug Administration( FDA) on AXS-05 for agitation in patients with Alzheimer’s disease.
- Received Fast Track designation from the
FDAfor AXS-02 for the pain of knee osteoarthritis (OA) associated with bone marrow lesions (BMLs).
- Added to the broad-market Russell 3000® and small-cap Russell 2000® Indexes, as part of the Russell U.S. Indexes annual reconstitution.
Second Quarter 2016 Financial Results
- Research and development (R&D) expenses: R&D expenses were
$5.3 millionfor the quarter ended June 30, 2016compared to $1.6 millionfor the comparable period in 2015. The increase in R&D expenses was primarily due to the conduct of our Phase 3 clinical trials in complex regional pain syndrome (the CREATE-1 Study), treatment resistant depression (the STRIDE-1 Study), and knee OA associated with BMLs (the COAST-1 Study).
- General and administrative (G&A) expenses: G&A expenses were
$1.5 millionfor the quarter ended June 30, 2016compared to $0.5 millionfor the comparable period in 2015. The increase in G&A expenses was primarily due to external fees associated with operating as a public company, as well as an increase in personnel costs and stock compensation expense.
- Net loss: Net loss was
$6.8 million, or $(0.36)per share for the quarter ended June 30, 2016, compared to a net loss of $2.1 million, or $(0.19)per share for the quarter ended June 30, 2015.
- Cash: As of
June 30, 2016, Axsome had $38.8 millionof cash compared to $48.0 millionof cash as of December 31, 2015. Axsome currently anticipates that its cash will be sufficient to fund its anticipated operations into the third quarter of 2017.
- Shares outstanding: At
June 30, 2016, Axsome had 19,149,417 shares of common stock outstanding.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation and completion of the trials; the timing of and our ability to obtain and maintain
|Axsome Therapeutics, Inc.|
|Selected Consolidated Financial Data|
|Statements of Operations Information (unaudited):|
|Three Months Ended
||Six Months Ended
|June 30,||June 30,|
|Research and development||$||5,298,060||$||1,628,394||$||9,824,312||$||3,044,677|
|General and administrative||1,529,220||456,410||2,885,833||973,250|
|Total operating expenses||6,827,280||2,084,804||12,710,145||4,017,927|
|Loss from operations||(6,827,280||)||(2,084,804||)||(12,710,145||)||(4,017,927||)|
|Interest and other income (expense)||15,090||(211,062||)||32,014||(339,843||)|
|Change in fair value of warrant liability||—||16,572||—||17,442|
|Change in fair value of embedded derivative liabilities||—||149,900||—||70,800|
|Net loss per common share – basic and diluted||$||(0.36||)||$||(0.19||)||$||(0.66||)||$||(0.38||)|
|Weighted average common shares outstanding – basic and diluted||19,149,417||11,108,144||19,149,417||11,108,144|
|Balance Sheet Information:|
|June 30, 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: firstname.lastname@example.org www.axsome.com