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“In the first quarter we continued to advance all of our clinical programs, which include three ongoing Phase 3 trials with our lead product candidates AXS-02 and AXS-05,” said
Axsome is developing a portfolio of differentiated, patent-protected, CNS product candidates. CNS disorders are distressing, difficult-to-treat, and underserved with many having no approved or satisfactory treatments. Axsome accelerates the development of new CNS medicines in a cost-efficient manner, by utilizing novel mechanisms of action and novel delivery approaches of well-characterized molecules, combined with human proof-of-concept data and innovative clinical trial designs. Our pipeline includes two late-stage product candidates in Phase 3 development and preclinical candidates.
- AXS-05: Axsome is developing AXS-05 (bupropion and dextromethorphan fixed-dose combination) in two separate Phase 3 clinical programs for treatment resistant depression (TRD) and Alzheimer’s disease (AD) agitation.
February 2017, the U.S. Food and Drug Administration( FDA) granted Axsome Fast Track designation for AXS-05 for TRD. Axsome is enrolling the STRIDE-1 study, a Phase 3, multicenter, randomized, double-blind, active-controlled trial to assess the efficacy and safety of AXS-05 in TRD, defined as major depressive disorder which has failed to respond to two or more antidepressant treatments.
AD Agitation: In
May 2017, the FDAgranted Axsome Fast Track designation for AXS-05 for the treatment of AD agitation. In January 2017, Axsome received Investigational New Drug Application (IND) clearance from the FDAto proceed with a Phase 2/3 trial of AXS-05 in this indication. Axsome anticipates commencing this trial in the second quarter of 2017.
- AXS-02: Axsome is developing AXS-02 (disodium zoledronate tetrahydrate) in three separate Phase 3 clinical programs: complex regional pain syndrome (CRPS), knee osteoarthritis (OA) associated with bone marrow lesions (BMLs), and chronic low back pain (CLBP) associated with Modic changes (MCs).
CRPS: Axsome is enrolling the CREATE-1 study, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial to assess the efficacy and safety of AXS-02 in the treatment of pain in patients with CRPS. CREATE-1 incorporates an interim analysis for efficacy which will be conducted on the first approximately 95 enrolled subjects.
Knee OA associated with BMLs: Axsome is evaluating AXS-02 in the COAST-1 study, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial to assess the efficacy and safety of AXS-02 in the treatment of the pain of knee OA associated with BMLs. Screening of subjects in this trial is paused pending results of the interim analysis on the first approximately 60 subjects enrolled in the trial to assess the assumptions used to determine the sample size of the study.
CLBP associated with MCs: In
February 2017, Axsome received IND clearance from the FDAto proceed with a Phase 3 trial of AXS-02 in the treatment of CLBP associated with MCs. The start of this trial is planned following readouts from Axsome’s ongoing Phase 3 trials in CRPS and TRD.
- Other Programs: Axsome is currently evaluating additional product candidates, including AXS-06, that it intends to develop for CNS disorders, including chronic pain.
March 2017, Axsome completed an underwritten public offering of common stock raising gross proceeds of approximately $16.1 million, which includes full exercise of the underwriter’s option to purchase additional shares.
Anticipated Near-Term Clinical Milestones
- Clinical Trial Initiations:
-- Phase 2/3 clinical trial of AXS-05 in AD agitation (2Q 2017)
- Clinical Trial Readouts:
-- Phase 3 COAST-1 trial of AXS-02 in knee OA associated with BMLs, interim analysis (3Q 2017)
-- Phase 3 CREATE-1 trial of AXS-02 in CRPS, interim efficacy analysis (4Q 2017)
-- Phase 3 STRIDE-1 trial of AXS-05 in TRD, top-line data (1Q 2018)
First Quarter 2017 Financial Results
- Research and development (R&D) expenses: R&D expenses were
$6.0 millionfor the quarter ended March 31, 2017compared to $4.5 millionfor the comparable period in 2016. The increase in R&D expenses was primarily due to the conduct of the CREATE-1, STRIDE-1, and COAST-1 Phase 3 clinical trials, as well as product candidate manufacturing costs.
- General and administrative (G&A) expenses: G&A expenses were
$1.7 millionfor the quarter ended March 31, 2017compared to $1.4 millionfor the comparable period in 2016. The increase in G&A expenses was primarily related to stock compensation expense.
- Net loss: Net loss was
$8.0 million, or $(0.41)per share, for the quarter ended March 31, 2017compared to a net loss of $5.9 million, or $(0.31)per share, for the quarter ended March 31, 2016.
- Cash: As of
March 31, 2017, Axsome had $45.0 millionof cash compared to $36.6 millionof cash as of December 31, 2016.
- Shares outstanding: As of
March 31, 2017, Axsome had 23,543,667 shares of common stock outstanding.
- Financial guidance: Axsome believes that its cash as of
March 31, 2017will be sufficient to fund the company’s anticipated operations, based on its current operating plans, into the first quarter of 2019.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, interim analyses and completion of the trials; the timing of and our ability to obtain and maintain
|Axsome Therapeutics, Inc.|
|Selected Consolidated Financial Data|
|Statements of Operations Information (unaudited):|
|Three Months Ended March 31,|
|Research and development||$ 5,985,219||$ 4,526,252|
|General and administrative||1,686,814||1,356,613|
|Total operating expenses||7,672,033||5,882,865|
|Loss from operations||(7,672,033)||(5,882,865)|
|Interest and amortization of debt discount/premium (expense) income||(323,006)||16,924|
|Net loss||$ (7,995,039)||$ (5,865,941)|
|Net loss per common share – basic and diluted||$ (0.41)||$ (0.31)|
|Weighted average common shares outstanding – basic and diluted||19,537,897||19,149,417|
|Balance Sheet Information:
|March 31, 2017
||December 31, 2016*|
|Loan payable, current and long-term||9,855,252||9,739,607|
|*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