Axsome Therapeutics,Inc. (NASDAQ:AXSM) Files An 8-K Results of Operations and Financial Condition

ME Staff 8-k

7 years ago

Axsome Therapeutics,Inc. (NASDAQ:AXSM) Files An 8-K Results of Operations and Financial ConditionItem 2.02.Results of Operations and Financial Condition

On November8, 2017, Axsome Therapeutics,Inc. (the “Company” or “Axsome”) issued a press release announcing its financial results for the three months ended September30, 2017 and an update on the Company’s operations. The Company is furnishing a copy of the press release, which is attached hereto as Exhibit99.1.

In accordance with General Instruction B.2 of Form8-K, the information included in this Current Report on Form8-K (including Exhibit99.1 hereto), shall not be deemed “filed” for the purposes of Section18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act or Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.

Item 2.02.Other Events

On November8, 2017, Axsome provided, in the press release referenced above, an overview of recent product candidate pipeline events, corporate development activities, and anticipated near-term clinical milestones, as follows:

Pipeline Update

· 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 central nervous system (“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 July2017, Axsome announced enrollment of the first patient in the ADVANCE-1 study, a Phase 2/3, multicenter, randomized, double-blind, controlled trial to evaluate the efficacy and safety of AXS-05 in patients with agitation associated with AD.

· 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 December2017 to early January2018. Approaching the interim analysis, approximately 85 subjects have been randomized to date. Enrollment of subjects in the trial is ongoing and will continue through the interim analysis.

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.

In July2017, Axsome announced positive topline results from a Phase 1 pharmacokinetic study of AXS-06 which demonstrated, for the first time, rapid achievement of peak plasma levels of meloxicam after oral administration. The median Tmax for meloxicam, the trial’s primary endpoint, was 9 times faster for AXS-06 as compared to commercially available Mobic® (meloxicam) tablets. Axsome also received, from the U.S. Food and Drug Administration, Pre-Investigational New Drug Application written guidance on a proposed clinical developmental program for AXS-06. Based on this guidance, Axsome believes that AXS-06 is Phase 3-ready.

Corporate Update

· In September2017, Cedric O’Gorman, M.D. was appointed Senior Vice President, Clinical Development and Medical Affairs. Dr.O’Gorman was previously Vice President of Medical Affairs at Intra-Cellular Therapies; U.S. medical lead for psychiatry at Genentech/Roche; and Medical Director, U.S. Medical Affairs at Pfizer.

· In July2017, Axsome announced the appointment of John Golubieski as Chief Financial Officer (CFO) effective August4, 2017. Mr.Golubieski was previously CFO of Osmotica Holdings; CFO of Fougera Pharmaceuticals, the former U.S. business of Nycomed; Senior Vice President, Financial Planning& Analysis of King Pharmaceuticals; and Senior Director, Strategic Analysis in the Worldwide Medicines Group at Bristol-Myers Squibb.

Anticipated Near-Term Clinical Milestones

· Clinical Trial Readouts:

· Phase 3 CREATE-1 trial of AXS-02 in CRPS, interim efficacy analysis (late December2017 to early January2018)

· Phase 3 COAST-1 trial of AXS-02 in knee OA associated with BMLs, interim analysis (late December2017 to early January2018)

· Phase 3 STRIDE-1 trial of AXS-05 in TRD, top-line data (1H 2018)

Item 2.02. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number	Description
99.1	Press release dated November8, 2017.

Axsome Therapeutics, Inc. ExhibitEX-99.1 2 a17-26176_2ex99d1.htm EX-99.1 Exhibit 99.1 Axsome Therapeutics Reports Third Quarter 2017 Financial Results NEW YORK,…To view the full exhibit click here
About Axsome Therapeutics,Inc. (NASDAQ:AXSM)
Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company is engaged in developing therapies for the management of central nervous system (CNS) disorders, including pain. It operates in the business of developing novel therapies for the management of CNS disorders segment. Its product candidate, AXS-02 (disodium zoledronate tetrahydrate), is an oral, targeted, non opioid therapeutic for chronic pain. It is developing AXS 02 for the treatment of pain in over three conditions, such as complex regional pain syndrome (CRPS); knee osteoarthritis (OA) associated with bone marrow lesions (BMLs), and chronic low back pain (CLBP), associated with type I, or mixed type I and type II Modic changes (MCs). Its product candidate, AXS 05, is a fixed dose combination of dextromethorphan (DM) and bupropion. It is developing AXS 05 for the treatment of over two conditions, such as treatment resistant depression (TRD), and agitation in patients with Alzheimer’s disease (AD).