Axsome Therapeutics Reports Third Quarter 2018 Financial Results and Provides Business Update

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NEW YORK, Nov. 09, 2018 (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 third quarter ended September 30, 2018.

“Over the past several months, we have significantly advanced and broadened our late-stage CNS pipeline, now consisting of four product candidates which will soon be in efficacy trials in six different indications,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “We announced the newest addition to our CNS portfolio, AXS-12 for the treatment of narcolepsy, which has recently received FDA Orphan Drug designation. During the same period, we also positioned our non-CNS assets for enhanced value creation by placing them in a newly formed business unit, Axsome PPC.”

“Through a recently completed equity offering with institutional investors, we have extended our cash runway into the first quarter of 2020, beyond several important clinical milestones,” continued Dr. Tabuteau. “We are pleased to announce that we now expect final results from the Phase 3 STRIDE-1 trial of AXS-05 in treatment resistant depression in the first quarter of 2019, versus previous guidance of the first half of 2019. The acceleration of this pivotal trial readout is enabled by our decision to forgo the previously planned second interim analysis in favor of a final analysis. For the Phase 2/3 ADVANCE-1 trial of AXS-05 in Alzheimer’s disease agitation, we are on track to report results of the interim futility analysis in the fourth quarter. In addition, topline results from the Phase 2 ASCEND trial of AXS-05 in major depressive disorder are expected around year end, and topline results from the Phase 2 trial of AXS-05 in smoking cessation are anticipated in the first quarter of 2019. We anticipate launching our planned Phase 3 trial of AXS-07 in migraine in the fourth quarter of this year or the first quarter of 2019. Finally, we continue to expect to launch a Phase 2 trial of AXS-12 in narcolepsy before the end of this year, with data from this trial expected in the first half of 2019.”

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 who suffer from these disorders are often underserved with many having no approved or satisfactory treatment options. Axsome accelerates the development of new CNS medicines by utilizing proprietary medicinal chemistry and formulation technologies, novel mechanisms of action, and well-characterized molecules, combined with human proof-of-concept data and innovative clinical trial designs. Axsome’s technologies include metabolic inhibition, MoSEIC™ delivery, chiral chemistry and formulation, and proprietary chemical synthesis and analysis. Our CNS pipeline includes four differentiated, clinical-stage product candidates.

Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss third quarter 2018 financial results as well as to provide a corporate update. To participate in the live conference call, please dial (844) 698-4029 (toll-free domestic) or (647) 253-8660 (international), and use the conference ID 9186796. The live webcast can be accessed on the "Webcasts & Presentations" page of the "Investors" section of the Company's website at axsome.com. A replay of the webcast will be available for approximately 30 days following the live event.

Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. Axsome’s core CNS product candidate portfolio includes four clinical-stage candidates, AXS-05, AXS-07, AXS-09, and AXS-12. AXS-05 is currently in a Phase 3 trial in treatment resistant depression (TRD), a Phase 2/3 trial in agitation associated with Alzheimer’s disease (AD), a Phase 2 trial in Major Depressive Disorder (MDD), and a Phase 2 trial in smoking cessation. AXS-07 is being developed for the acute treatment of migraine. AXS-12 is being developed for the treatment of the symptoms of narcolepsy. The Axsome Pain and Primary Care business unit (Axsome PPC) houses Axsome’s pain and primary care assets, including AXS-02 and AXS-06, and intellectual property which covers these and related product candidates and molecules being developed by Axsome and others. AXS-02 is being developed for osteoporosis, the pain of knee osteoarthritis, and chronic low back pain. AXS-06 is being developed for osteoarthritis and rheumatoid arthritis. AXS-02, AXS-05, AXS-06, AXS-07, AXS-09, and AXS-12 are investigational drug products not approved by the FDA. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website.

Certain matters discussed in this press release are “forward-looking statements”. The Company 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 the Company’s ongoing clinical trials and anticipated clinical trials for its current product candidates, including statements regarding the timing of initiation, interim analyses and completion of the trials, futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; the Company’s ability to fund additional clinical trials to continue the advancement of its product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, its product candidates; the Company’s expected cash runway; 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.

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Globe Newswire: 12:00 GMT Friday 9th November 2018

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