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“2015 was a pivotal year for Axsome as we accomplished a number of important milestones including initiating our Phase 3 trial with AXS-02 in complex regional pain syndrome, as well as completing our initial public offering,” said
“So far in 2016, we have advanced AXS-05, our second lead product candidate, into a registration trial in treatment resistant depression. AXS-05 is an innovative oral therapeutic, with activity at several key neurotransmitter systems, which we are developing for the treatment of CNS disorders. We look forward to continued progress with our other clinical programs throughout the rest of this year, including advancing AXS-02 into trials in additional pain indications. As a reminder, AXS-02 is an oral, non-opioid, targeted, potentially first-in-class therapeutic which we are developing for chronic pain.”
2015 and Recent Corporate Highlights
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 the treatment of treatment resistant depression (TRD).
November 2015, successfully completed an initial public offering (IPO) of common stock, which raised gross proceeds of approximately $51 million.
October 2015, received a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration( FDA) for the COAST-1 (Clinical Knee Osteoarthritis Symptom Treatment 1) study. COAST-1 is a Phase 3 clinical trial of AXS-02 for the treatment of the pain of knee osteoarthritis (OA) associated with bone marrow lesions (BMLs).
July 2015, enrolled the first patient in the CREATE-1 (CRPS Treatment Evaluation 1) study, a Phase 3 trial evaluating the efficacy and safety of AXS-02 for the treatment of complex regional pain syndrome (CRPS).
- Began preparations to file an Initial Drug Application (IND) for a Phase 3 trial of AXS-02 for the treatment of chronic low back pain (CLBP) associated with Modic changes (MCs). Initiation of this trial is currently anticipated in the fourth quarter of 2016 or the first quarter of 2017.
Fourth Quarter and Full Year 2015 Financial Results
- Research and development (R&D) expenses: R&D expenses were
$2.2 millionfor the quarter ended December 31, 2015, and $6.8 millionfor the year ended December 31, 2015, compared to $1.3 millionand $4.3 millionfor the comparable periods in 2014. The increase in R&D expenses was primarily due to increased clinical trial expenses related to the initiation of the CREATE-1 study, increased manufacturing expenses for Axsome’s two lead product candidates, AXS‑02 and AXS‑05, and an increase in personnel costs and stock compensation expense in 2015. R&D expenses in 2016 are expected to increase as compared to 2015 in connection with the conduct of our Phase 3 clinical trials.
- General and administrative (G&A) expenses: G&A expenses were
$0.9 millionfor the quarter ended December 31, 2015, and $2.4 millionfor the year ended December 31, 2015, compared to $0.6 millionand $1.4 millionfor the comparable periods in 2014. The increase in G&A expenses was primarily due to an increase in personnel costs, stock compensation expense, and professional fees associated with becoming a public company. G&A expenses are expected to increase in 2016 as compared to 2015 primarily associated with the costs of being a public company.
- Net loss: Net loss was
$1.7 million, or $0.12per share for the quarter ended December 31, 2015, compared to a net loss of $1.5 million, or $0.14per share for the quarter ended December 31, 2014. Net loss for the year ended December 31, 2015was $10.6 million, or $0.88per share, compared to a net loss of $6.0 million, or $0.66per share for the year ended December 31, 2014.
- Cash: As of
December 31, 2015, Axsome had $48.0 millionof cash compared to $2.6 millionof cash as of December 31, 2014. The increase in cash is principally related to the company’s IPO, completed in November 2015, which raised gross proceeds of approximately $51.0 millionand net proceeds of approximately $45.5 million, after deducting underwriting discounts and commissions and offering-related transaction costs. Axsome currently anticipates that its cash will be sufficient to fund its anticipated operations into the third quarter of 2017.
- Shares outstanding: At
December 31, 2015, Axsome had 19,149,417 shares of common stock outstanding.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation and completion of the trials; the timing of and our ability to obtain and maintain
|Axsome Therapeutics, Inc.|
|Selected Consolidated Financial Data|
|Statements of Operations Information:|
|Three Months Ended December 31,||Year Ended December 31,
|Research and development||$||2,207,915||$||1,347,527||$||6,776,987||$||4,279,200|
|General and administrative||946,618||600,837||2,419,289||1,392,830|
|Total operating expenses||3,154,533||1,948,364||9,196,276||5,672,030|
|Loss from operations||(3,154,533||)||(1,948,364||)||(9,196,276||)||(5,672,030||)|
|Interest and amortization of debt discount/premium income (expense)||1,534,597||334,198||914,952||2,233,338|
|Change in fair value of warrant liability||(93,976||)||(57,106||)||(108,539||)||(57,106||)|
|Change in fair value of embedded derivative liabilities||—||182,000||274,800||182,000|
|Loss on extinguishment of debt||—||—||(2,444,516||)||(2,870,903||)|
|Net loss per common share – basic and diluted||$||(0.12||)||$||(0.14||)||$||(0.88||)||$||(0.66||)|
|Weighted average common shares outstanding – basic and diluted||14,429,540||10,998,556||11,945,318||9,099,188|
|Balance Sheet Information:|
|December 31, 2015
||December 31, 2014|
|Stockholders’ equity (deficit)||$||46,444,261||$||(3,202,575||)|
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