Press Release: Axsome Therapeutics Reports Second Quarter 2016 Financial Results

Press Release: Axsome Therapeutics Reports Second Quarter 2016 Financial Results

Axsome Therapeutics Reports Second Quarter 2016 Financial Results

NEW YORK, Aug. 09, 2016 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today reported financial results for the second quarter ended June 30, 2016.

“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 FDA guidance on our development plans for AXS-05 in Alzheimer’s agitation,” said Herriot Tabuteau, M.D., Chief Executive Officer of Axsome Therapeutics. “Based on this guidance, we look forward to filing an IND for a Phase 2/3 trial in this indication by year end.”

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 FDA for AXS-02 for the pain of 
      knee osteoarthritis (OA) associated with bone marrow lesions (BMLs). 
 
   -- Added to the broad-market Russell 3000(R) and small-cap Russell 2000(R) 
      Indexes, as part of the Russell U.S. Indexes annual reconstitution. 
 Stock Market Quotes, Business News, Financial News from http://commodity-market-news.com

Second Quarter 2016 Financial Results

   -- Research and development (R&D) expenses: R&D expenses were $5.3 million 
      for the quarter ended June 30, 2016 compared to $1.6 million for 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 million 
      for the quarter ended June 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 $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 million of cash compared to 
      $48.0 million of 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. 
 

About Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, including pain, for which there are limited existing treatment options. Axsome’s product candidate portfolio includes two late-stage candidates, AXS-02 and AXS-05. AXS-02 is currently in Phase 3 trials in complex regional pain syndrome (CRPS) and knee osteoarthritis (OA) associated with bone marrow lesions (BMLs) with an additional Phase 3 trial planned in chronic low back pain (CLBP) associated with Modic changes (MCs). AXS-05 is currently in a Phase 3 trial in treatment resistant depression (TRD), and a Phase 2/3 trial in agitation in patients with Alzheimer’s disease (AD) is planned. AXS-02 and AXS-05 are investigational product candidates not approved by the FDA. For more information, please visit the company website at www.axsome.com. The company may occasionally disseminate material, nonpublic information on the company website.

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 U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s product candidates, if approved; and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.

 
                          Axsome Therapeutics, Inc. 
                     Selected Consolidated Financial Data 
 
Statements of 
Operations 
Information 
(unaudited): 
 
                        Three Months Ended            Six Months Ended 
                             June 30,                     June 30, 
 
                         2016          2015          2016           2015 
 
Operating 
expenses: 
   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             $(6,812,190)  $(2,129,394)  $(12,678,131)  $(4,269,528) 
                      ==========    ==========    ===========    ========== 
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* 
                         (unaudited) 
Cash                   $  38,751,750    $        48,036,260 
Total assets              40,007,913             49,076,156 
Accumulated deficit      (33,117,929)           (20,439,798) 
Stockholders' equity   $  34,904,355    $        46,444,261 
 
*Condensed from audited financial statements. 
 
 
Axsome Contact: 
Mark Jacobson 
Vice President, Operations 
Axsome Therapeutics, Inc. 
25 Broadway, 9th Floor 
New York, NY 10004 
Tel: 212-332-3243 
Email: mjacobson[a]axsome.com 
www.axsome.com