|View printer-friendly version|
“In the third quarter we launched our Phase 2/3 ADVANCE-1 trial of AXS-05 in Alzheimer’s disease agitation and reported positive Phase 1 trial results with our new clinical-stage product candidate, AXS-06,” said
Axsome is developing a portfolio of differentiated, patent-protected, central nervous system (CNS) product candidates. CNS disorders are distressing and difficult-to-treat. The patients with them are often underserved with many having no approved or satisfactory treatment options. 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 product candidates in Phase 3 development, one candidate which we believe to be Phase 3-ready, and additional preclinical candidates.
• AXS-05: Axsome is evaluating 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. AXS-05 is a novel fixed-dose combination of dextromethorphan (an NMDA receptor antagonist, sigma-1 receptor agonist, and serotonin and norepinephrine reuptake inhibitor) and bupropion (a norepinephrine and dopamine reuptake inhibitor, which also increases the bioavailability of dextromethorphan), under development for the treatment of CNS disorders.
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
• AXS-02: Axsome is evaluating 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). AXS-02 is a potent osteoclast inhibitor being developed as an oral, non-opioid, targeted, potentially first-in-class therapeutic for chronic pain.
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 performed by an independent data monitoring committee (IDMC) and results of the analysis are expected late
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. An interim analysis to assess the sample size of the study will be performed by an IDMC on the first approximately 60 subjects enrolled in the trial. The interim analysis will be performed by the same IDMC and at the same meeting as the interim analysis for the CREATE-1 trial.
• AXS-06: Axsome is developing AXS-06 (MoSEIC™ meloxicam and esomeprazole) for the relief of the signs and symptoms of OA and Rheumatoid Arthritis (RA), and the reduction in the risk of developing upper gastrointestinal ulcers in patients at risk of developing nonsteroidal anti-inflammatory drug (NSAID) associated upper gastrointestinal ulcers. AXS-06 is an oral, non-opioid, rapidly-absorbed, once-daily, COX-2 preferential pain therapeutic with a gastroprotectant.
Anticipated Near-Term Clinical Milestones
• Clinical Trial Readouts:
- Phase 3 CREATE-1 trial of AXS-02 in CRPS, interim efficacy analysis (late
December 2017to early January 2018)
- Phase 3 COAST-1 trial of AXS-02 in knee OA associated with BMLs, interim analysis (late
December 2017to early January 2018)
- Phase 3 STRIDE-1 trial of AXS-05 in TRD, top-line data (1H 2018)
Third Quarter 2017 Financial Results
• Research and development (R&D) expenses: R&D expenses were
• General and administrative (G&A) expenses: G&A expenses were
• Net loss: Net loss was
• Cash: As of
• Shares outstanding: As of
• Financial guidance: Axsome believes that its cash as of
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
|Nine Months Ended
|Research and development||$||4,471,126||$||5,568,777||$||15,463,706||$||15,393,089|
|General and administrative||1,826,290||1,639,026||5,256,481||4,524,859|
|Total operating expenses||6,297,416||7,207,803||20,720,187||19,917,948|
|Loss from operations||(6,297,416||)||(7,207,803||)||(20,720,187||)||(19,917,948||)|
|Interest and amortization of debt discount/premium (expense) income||(343,234||)||13,219||(999,818||)||45,233|
|Net loss per common share – basic and diluted||$||(0.27||)||$||(0.38||)||$||(0.97||)||$||(1.04||)|
|Weighted average common shares outstanding – basic and diluted||23,634,040||19,149,906||22,270,885||19,149,579|
|Balance Sheet Information:|
|September 30, 2017||December 31, 2016*|
|Loan payable, current and long-term||10,092,481||9,739,607|
*Condensed from audited financial statements.