Axsome Therapeutics Reports Third Quarter 2016 Financial Results
“We continued to advance our three Phase 3 trials during this quarter,” said
Third Quarter and Recent Corporate Highlights
- Active enrollment continued in our three ongoing Phase 3 trials: the CREATE-1 trial in complex regional pain syndrome (CRPS), the STRIDE-1 trial in treatment resistant depression, and the COAST-1 trial in knee osteoarthritis associated with bone marrow lesions. To date approximately 40 subjects have been enrolled in CREATE-1 and the study currently has 45 activated sites. CREATE-1 incorporates an interim efficacy analysis that is triggered when approximately 95 enrolled subjects complete the double-blind portion of the trial. Based upon current trends, we anticipate reaching this enrollment target in the first or second quarter of 2017.
October 2016, results of a nonclinical study of AXS-02 in a well-validated animal model of CRPS were published in Anesthesia & Analgesia, a peer-reviewed journal. The results showed that in this model, AXS-02 completely reversed established pain and improved function.
November 2016, we entered into a $20 millionterm loan agreement with Silicon Valley Bank. We have drawn $10 millionof this amount and can draw the remaining $10 millionsubject to the achievement of certain clinical and financial milestones. This financing strengthens our balance sheet ahead of potential clinical data releases, allows us to conduct our planned Phase 2/3 trial of AXS-05 in agitation in patients with Alzheimer’s disease, and extends our cash runway.
Third Quarter 2016 Financial Results
- Research and development (R&D) expenses: R&D expenses were
$5.6 millionfor the quarter ended September 30, 2016compared to $1.5 millionfor the comparable period in 2015. The increase in R&D expenses was primarily due to the conduct of our CREATE-1, STRIDE-1, and COAST-1 Phase 3 clinical trials.
- General and administrative (G&A) expenses: G&A expenses were
$1.6 millionfor the quarter ended September 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
$7.2 million, or $(0.38)per share for the quarter ended September 30, 2016, compared to a net loss of $4.6 million, or $(0.41)per share for the comparable period in 2015.
- Cash: At
September 30, 2016, Axsome had $33.9 millionof cash compared to $48.0 millionof cash at December 31, 2015. Axsome believes that its cash at September 30, 2016, combined with the proceeds from the initial $10 milliontranche of the term loan with Silicon Valley Bank, will be sufficient to fund the company’s anticipated operations through the end of 2017.
- Shares outstanding: At
September 30, 2016, Axsome had 19,153,417 shares of common stock outstanding.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation and completion of the trials; the timing of and our ability to obtain and maintain
|Axsome Therapeutics, Inc.|
|Selected Consolidated Financial Data|
|Statements of Operations Information (unaudited):|
|Three Months Ended September 30,
||Nine Months Ended September 30,
|Research and development||$||5,568,777||$||1,524,395||$||15,393,089||$||4,569,072|
|General and administrative||1,639,026||499,421||4,524,859||1,472,671|
|Total operating expenses||7,207,803||2,023,816||19,917,948||6,041,743|
|Loss from operations||(7,207,803||)||(2,023,816||)||(19,917,948||)||(6,041,743||)|
|Interest and other income (expense)||13,219||(279,802||)||45,233||(619,645||)|
|Change in fair value of warrant liability||—||(32,005||)||—||(14,563||)|
|Change in fair value of embedded derivative liabilities||—||204,000||—||274,800|
|Loss on extinguishment of debt||—||(2,444,516||)||—||(2,444,516||)|
|Net loss per common share – basic and diluted||$||(0.38||)||$||(0.41||)||$||(1.04||)||$||(0.80||)|
|Weighted average common shares outstanding – basic and diluted||19,149,906||11,108,144||19,149,579||11,108,144|
|Balance Sheet Information:|
|September 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