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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Axsome Therapeutics Inc | NASDAQ:AXSM | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 73.69 | 73.00 | 75.98 | 0 | 13:31:52 |
“So far this year, we have significantly advanced our pipeline of differentiated investigational medicines that have the potential to transform the lives of many of the millions of people living with difficult-to-treat CNS disorders. Our three CNS product candidates in active clinical development are being evaluated in six efficacy trials, including five Phase 3 trials and one Phase 2 trial, across five different indications,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “It is an exciting time for Axsome and a potentially important time for patients and clinicians as all these studies are fast approaching completion. Specifically, topline readouts from the GEMINI Phase 3 trial of AXS-05 in major depressive disorder, the MOMENTUM Phase 3 trial of AXS-07 in the acute treatment of migraine, and the CONCERT Phase 2 trial of AXS-12 in narcolepsy are all expected before year end. We are also concluding patient screening in the Phase 3 STRIDE-1 trial of AXS-05 in treatment resistant depression at the end of this month, allowing for a meaningful proportion of patients from this trial to be included in the long-term safety database which is required for an NDA filing. As a result, topline data from this trial are now expected in the first quarter of 2020. Also anticipated next year are topline results from the Phase 2/3 ADVANCE-1 trial of AXS-05 in Alzheimer’s disease agitation in the first half of 2020 and, importantly, potentially two NDA filings, for AXS-05 in major depressive disorder and for AXS-07 in the acute treatment of migraine, in the second half of 2020.”
CNS Pipeline Update
Axsome is developing a portfolio of differentiated, patent-protected, central nervous system (CNS) product candidates. CNS disorders are distressing for patients, difficult to treat, and underserved. Axsome accelerates the development of new CNS medicines by utilizing proprietary technologies and novel mechanisms of action, 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. The Company’s CNS pipeline includes three differentiated product candidates in active clinical development.
Scientific Meeting Presentations
Corporate Update
Anticipated Milestones
Upcoming Migraine Key Opinion Leaders Conference Call and Webcast
Axsome will host an investor R&D conference call and webcast on November 25, 2019 with migraine key opinion leaders (KOLs), focusing on AXS-07 and the unmet needs in the acute treatment of migraine.
This R&D event will feature presentations from Dr. Stewart J. Tepper, Professor of Neurology at The Geisel School of Medicine at Dartmouth, and from Dr. Richard B. Lipton, Professor and Vice Chair of Neurology, and Director of the Montefiore Headache Center, at the Albert Einstein College of Medicine. Additional event details including the agenda and access information will be provided at a later date.
Third Quarter 2019 Financial Results
Financial Guidance
Conference Call Information
Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss third quarter 2019 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 3389043. 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.
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 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 3 trial in major depressive disorder (MDD), and a Phase 2/3 trial in agitation associated with Alzheimer’s disease (AD). AXS-05 is also being developed for smoking cessation treatment. AXS-07 is currently in two Phase 3 trials for the acute treatment of migraine. AXS-12 is currently in a Phase 2 trial in narcolepsy. AXS-05, 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.
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, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our product candidates (including, but not limited to, FDA’s agreement with the Company’s plan to discontinue the bupropion treatment arm of the ADVANCE-1 study in accordance with the independent data monitoring committee’s recommendations); the potential for the ASCEND clinical trial to provide a basis for approval of AXS-05 for the treatment of major depressive disorder and accelerate its development timeline and commercial path to patients; 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; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings prior to the readout from its Phase 3 trials; 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:
Three months ended | |||||
September 30, | |||||
2019 | 2018 | ||||
Operating expenses: | |||||
Research and development | $ | 15,835,573 | $ | 6,040,780 | |
General and administrative | 3,1111,662 | 2,202,679 | |||
Total operating expenses | 18,947,235 | 8,243,459 | |||
Loss from operations | (18,947,235) | (8,243,459) | |||
Interest and amortization of debt discount (expense) | (327,825) | (270,933) | |||
Tax Credit | 139,448 | 217,418 | |||
Change in fair value of warrant liability | — | 15,000 | |||
Net loss | $ | (19,135,612) | $ | (8,281,974) | |
Net loss per common share, basic and diluted | $ | (0.56) | $ | (0.31) | |
Weighted average common shares outstanding, basic and diluted | 34,445,489 | 26,325,904 |
Balance Sheet Information:
September 30, 2019 | December 31, 2018 | ||||
Cash | $ | 43,641,861 | $ | 13,968,742 | |
Total assets | 44,439,729 | 15,379,279 | |||
Loan payable, current and long-term | 19,756,667 | 6,910,814 | |||
Accumulated deficit | (151,088,509) | (107,550,307) | |||
Stockholders’ equity | $ | 6,822,596 | $ | 937,921 |
Axsome Contact: Mark Jacobson Senior Vice President, Operations Axsome Therapeutics, Inc. 200 Broadway, 3rd Floor New York, NY 10038 Tel: 212-332-3243 Email: mjacobson@axsome.com www.axsome.com
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