- 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.
- In 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.
- In November 2016, we entered into a $20 million term loan agreement with Silicon Valley Bank. We have drawn $10 million of this amount and can draw the remaining $10 million subject 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.
- Research and development (R&D) expenses: R&D expenses were $5.6 million for the quarter ended September 30, 2016 compared to $1.5 million for 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 million for the quarter ended September 30, 2016 compared to $0.5 million for 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 million of cash compared to $48.0 million of cash at December 31, 2015. Axsome believes that its cash at September 30, 2016, combined with the proceeds from the initial $10 million tranche of the term loan with Silicon Valley Bank, will be sufficient to fund the company's anticipated operations through the end of 2017.
- Shares outstanding: At September 30, 2016, Axsome had 19,153,417 shares of common stock outstanding.
|Axsome Therapeutics, Inc.|
|Selected Consolidated Financial Data|
|Statements of Operations Information (unaudited):|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||$||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 (unaudited)||December 31, 2015*|
|*Condensed from audited financial statements.|
Axsome Contact: Mark JacobsonVice President, OperationsAxsome Therapeutics, Inc.25 Broadway, 9th FloorNew York, NY 10004Tel: 212-332-3243Email: email@example.com www.axsome.com