Item 7.01 Regulation FD Disclosure.
On
The Company believes that its current cash and cash equivalents, along with the remaining committed capital from its credit facility, is sufficient to fund its anticipated operations into cash flow positivity, based on the current operating plan.
The Company remains focused on the commercialization of Auvelity®, its FDA Breakthrough Therapy designated product approved for the treatment of major depressive disorder, and Sunosi®, approved by the FDA to improve wakefulness in adults living with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. The Company also continues to advance its late-stage neuroscience pipeline which includes AXS-05 for Alzheimer's disease agitation, AXS-07 for migraine, AXS-12 for narcolepsy, AXS-14 for fibromyalgia, and solriamfetol for attention deficit hyperactivity disorder ("ADHD").
The information in this Item 7.01 is being furnished and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Item 7.01 shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended.
Forward-Looking Statements
This Current Report on Form 8-K may contain "forward-looking statements", within
the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended, related to our
study analyses, clinical trials, regulatory submissions, and projected cash
position. We may, in some cases use terms such as "future," "predicts,"
"believes," "potential," "continue," "anticipates," "estimates," "expects,"
"plans," "intends," "targeting," "confidence," "may," "could," "might,"
"likely," "will," "should" or other words that convey uncertainty of the future
events or outcomes to identify these forward-looking statements. The Company's
forward-looking statements are based on current beliefs and expectations of the
Company's management team that involve risks, potential changes in
circumstances, assumptions, and uncertainties. Any or all of the forward-looking
statements may turn out to be wrong or be affected by inaccurate assumptions the
Company might make or by known or unknown risks and uncertainties. These
forward-looking statements are subject to risks and uncertainties including the
Company's statements regarding its liquidity, cash position and whether there
could be an administrative delay to access its capital held on deposit at SVB or
cash sweep program administrated by SVB, risks related to the commercial success
of the Company's products, risks related to the success and timing of the
Company's clinical trials or other studies, the possibility that the Company may
be adversely affected by geopolitical and other economic, business and/or
competitive factors, the Company's estimates of its financial performance, and
the other risks set forth in the Company's filings with the
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits Exhibit No. Description 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
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