Axsome Therapeutics to Report Fourth Quarter and Full Year 2021 Financial Results on March 1, 2022

Rhea-AI Summary

Axsome Therapeutics (NASDAQ: AXSM) will report its Q4 and fiscal year 2021 financial results on March 1, 2022, before U.S. market opening. A conference call is scheduled for 8:00 AM ET on the same day to discuss these results and provide a business update. The event can be accessed via a live webcast on the company’s website. Axsome is focused on developing novel therapies for central nervous system disorders. The press release includes forward-looking statements regarding clinical trial outcomes and regulatory approvals, highlighting potential risks and uncertainties.

Positive

• None.

Negative

• Forward-looking statements indicate potential regulatory risks related to the approval timelines of AXS-05 and AXS-07.
• Clinical trial outcomes are uncertain, particularly with respect to FDA reviews impacting timelines and approvability.

Axsome to host conference call and webcast on Tuesday, March 1, 2022 at 8:00 AM Eastern Time

NEW YORK, Feb. 15, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that it will report its fourth quarter and fiscal year 2021 financial results on Tuesday, March 1, 2022 before the opening of the U.S. financial markets. Axsome’s management team will host a conference call at 8:00 AM Eastern Time on March 1, 2022 to discuss these results and provide a business update.

To participate in the live conference call, please dial (844) 200-6205 (toll-free domestic) or (929) 526-1599 (international) and use the conference ID 147872. A live webcast of the conference call can be accessed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at www.axsome.com. A recording of the conference call will be available on the Company’s website for approximately 30 days following the live event.

About Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians. 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 potential filing issues or issues identified by FDA during the substantive review may impact the potential approvability of the Company’s NDA submission for AXS-05 in MDD or 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); whether issues identified by FDA during the substantive review may impact the potential approvability of the Company’s 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; 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 Contact:
Mark Jacobson
Chief Operating Officer
Axsome Therapeutics, Inc.
22 Cortlandt Street, 16^th Floor
New York, NY 10007
Tel: 212-332-3243
Email: mjacobson@axsome.com
www.axsome.com

 

FAQ

When will Axsome report its Q4 and fiscal year 2021 financial results?

Axsome Therapeutics will report its Q4 and fiscal year 2021 financial results on March 1, 2022, before the U.S. market opens.

What is the purpose of the conference call hosted by Axsome on March 1, 2022?

The conference call will discuss the Q4 and fiscal year 2021 financial results and provide a business update.

How can I access the Axsome conference call on March 1, 2022?

The conference call can be accessed by calling (844) 200-6205 (domestic) or (929) 526-1599 (international) and using conference ID 147872. A live webcast will also be available on the company’s website.

What are the potential risks mentioned in Axsome's press release?

The press release mentions risks related to the success and timing of clinical trials, FDA approvals, and other uncertainties affecting future results.