Axsome Therapeutics Amends Silicon Valley Bank Loan Agreement Increasing Financial Flexibility
29 July 2019 - 9:00PM
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage
biopharmaceutical company developing novel therapies for the
management of central nervous system (CNS) disorders, announced
that it has amended its existing $24 million term loan facility
agreement led by Silicon Valley Bank (SVB). The amendment extends
the interest-only payment period as well as the time for drawing
down additional funding under the loan facility. These
modifications are expected to further extend the Company’s cash
runway, and provide additional financial flexibility.
Axsome entered into the $24 million loan
agreement in March 2019. The amendment extends the interest-only
payment period by a minimum of six months to 18 months, which may
be further extended to 24 months should the Company elect to draw
down an additional $4 million that remains unfunded under the loan
agreement. The period to draw this remaining amount has also been
extended to December 31, 2019, subject to the achievement of
positive results, prior to this date, from the Company’s ongoing
CONCERT Phase 2 trial of AXS-12 in narcolepsy sufficient to proceed
to a Phase 3 trial. In consideration for the amendment, the final
payment fee, payable upon the Company’s repayment of the loan,
increased from 6.0% to 6.3% of the principal amount of the loan
advances. All other terms and conditions from the original term
loan agreement remain substantially unchanged. Additional details
of the loan amendment will be filed with the Securities and
Exchange Commission on a Current Report on Form 8-K.
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 a
Phase 3 trial for the acute treatment of migraine. AXS-12 is
currently in a Phase 2 trial in 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.
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, 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; 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 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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