Full Press Release Details
Axsome Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update
Company to host conference call today at 8:00 AM Eastern
NEW YORK, March 1, 2021 (Globe Newswire) - Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today reported financial results for the fourth quarter and year ended December 31, 2020.
"The focused execution of the Axsome team made 2020 a year of significant accomplishments. We had successful pre-NDA meetings with the FDA for AXS-05 in major depressive disorder and for AXS-07 in migraine, reported positive results from the pivotal ADVANCE-1 trial of AXS-05 in Alzheimer's disease agitation, initiated the second pivotal trial of AXS-05 in this indication, received two new FDA Breakthrough Therapy designations, and built out our commercialization infrastructure," said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. "So far this year, we have submitted to the FDA the NDA for AXS-05 in major depressive disorder, and are nearing submission of the NDA for AXS-07 in the acute treatment of migraine, which is expected early in the second quarter. Our focus for the remainder of the year will be on the regulatory activities surrounding these NDAs, launch readiness to ensure a successful transition to commercialization, assuming product approvals, and continued advancement of the rest of our differentiated late-stage CNS pipeline."
For the many people living with serious CNS disorders, Axsome accelerates the invention and development of life-changing medicines. The Company is developing a portfolio of differentiated, patent-protected, CNS product candidates with four in active clinical development.
Depression: Axsome has submitted a New Drug Application (NDA) to the FDA for AXS-05 for the treatment of MDD. The Company intends to issue a press release following the FDA's decision on the filing of the application.
In December 2020, Axsome announced positive results from the COMET Phase 3 long-term trial in patients with MDD and the three Phase 2 open-label MDD efficacy trials in patients who had failed one prior antidepressant (COMET-AU), patients who had failed two prior antidepressants (COMET-TRD), and patients with suicidal ideation. Patients treated with AXS-05 in these trials experienced rapid, substantial, and durable improvement in depressive symptoms and functional impairment that was sustained over the 12-month treatment period. AXS-05 was well tolerated over the long-term treatment period with a safety profile consistent with that observed in the previously reported controlled trials.
AD Agitation: In December 2020, Axsome initiated the ACCORD study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter, randomized withdrawal trial to evaluate the efficacy and safety of AXS-05 in the treatment of Alzheimer's disease (AD) agitation.
Smoking Cessation: Axsome is scheduled to meet with the FDA in the third quarter of 2021 to discuss the continued clinical development of AXS-05 as an aid to smoking cessation treatment. Axsome previously announced positive results from a Phase 2 trial of AXS-05 for smoking cessation treatment conducted under a research collaboration between Axsome and Duke University.
Migraine: Axsome is compiling the NDA for AXS-07 for the acute treatment of migraine. Submission of this NDA is expected in early second quarter.
In December 2020, Axsome announced positive results from the MOVEMENT Phase 3 long-term trial of AXS 07 in the acute treatment of migraine. In this trial, treatment with AXS-07 resulted in rapid, substantial, and durable relief of migraine pain and associated symptoms. AXS-07 was well tolerated over the 12-month treatment period with a safety profile consistent with that observed in the previously reported controlled trials.
Narcolepsy: Axsome is planning to initiate a Phase 3 trial of AXS-12 in the treatment of narcolepsy in the second quarter. The planned Phase 3 trial will be a randomized, double-blind, placebo-controlled, parallel-group study.
Fibromyalgia: Axsome is scheduled to meet with the FDA in the second quarter, to discuss the further clinical development of AXS-14 for the treatment of fibromyalgia. AXS-14 has previously met the primary endpoints and demonstrated positive and statistically significant results in a Phase 3 and in a Phase 2 trial for the treatment of fibromyalgia.
Anticipated Milestones
Fourth Quarter 2020 Financial Results
Conference Call Information
Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss fourth quarter and full year 2020 financial results as well as to provide a corporate update. To participate in the live conference call, please dial (866) 393-4306 (toll-free domestic) or (734) 385-2616 (international), and use the conference ID 3782547. 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 biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. For the many people facing unsatisfactory treatments for CNS disorders, Axsome accelerates the invention and adoption of life-changing medicines. Axsome's core CNS product candidate portfolio includes five clinical-stage candidates, AXS-05, AXS 07, AXS-09, AXS-12, and AXS-14. AXS-05 is being developed for major depressive disorder (MDD), Alzheimer's disease (AD) agitation, and as a treatment for smoking cessation. AXS-07 is being developed for the acute treatment of migraine. AXS-12 is being developed for the treatment of narcolepsy. AXS-14 is being developed for fibromyalgia. AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14 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, whether the FDA will accept and subsequently approve of the Company's NDA submission for AXS-05 in MDD and the timing of such approval, and whether the FDA will agree with the Company's discontinuation of the bupropion treatment arm of the ADVANCE study in accordance with the independent data monitoring committee's recommendations); the successful submission of and approval by the FDA of an NDA for AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to our special protocol assessment for the MOMENTUM clinical trial; the potential for the ASCEND clinical trial, combined with the GEMINI clinical trial results, 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 amount of capital required for the Company's commercial launch of its product candidates, and the potential impact on the Company's anticipated cash runway; as well as unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19; 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 | Twelve months ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 17,384,729 | $ | 19,205,271 | $ | 70,244,579 | $ | 53,647,067 | ||||||||
| General and administrative | 10,359,507 | 5,222,899 | 28,896,749 | 13,598,030 | ||||||||||||
| Total operating expenses | 27,744,236 | 24,428,170 | 99,141,328 | 67,245,097 | ||||||||||||
| Loss from operations | (27,744,236 | ) | (24,428,170 | ) | (99,141,328 | ) | (67,245,097 | ) | ||||||||
| Interest and amortization of debt discount (expense) | (1,473,989 | ) | (378,814 | ) | (2,565,838 | ) | (1,239,537 | ) | ||||||||
| Tax Credit | 53,578 | - | 53,578 | 139,448 | ||||||||||||
| Loss on extinguishment of debt | - | - | (1,247,012 | ) | - | |||||||||||
| Net loss | $ | (29,164,647 | ) | $ | (24,806,984 | ) | $ | (102,900,600 | ) | $ | (68,345,186 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.78 | ) | $ | (0.71 | ) | $ | (2.77 | ) | $ | (2.01 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 37,351,117 | 34,757,910 | 37,206,928 | 34,020,257 |
Balance Sheet Information:
| December 31, 2020 | December 31, 2019 | |||||||
| Cash and cash equivalents | $ | 183,876,453 | $ | 219,966,167 | ||||
| Total assets | 186,134,323 | 220,549,760 | ||||||
| Loan payable, current and long-term | 48,321,848 | 19,934,918 | ||||||
| Accumulated deficit | (278,796,093 | ) | (175,895,493 | ) | ||||
| Stockholders' equity | $ | 113,792,909 | $ | 178,722,389 |
Chief Operating Officer
Axsome Therapeutics, Inc.
22 Cortlandt Street, 16th Floor
Email: mjacobson@axsome.com