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 first quarter ended March 31, 2020.
“The recent clinical successes in our late-stage
pipeline, including positive efficacy data in depression,
Alzheimer’s disease agitation, migraine, narcolepsy, and
fibromyalgia, highlight Axsome’s accelerated evolution into a
leading, innovative CNS company,” said Herriot Tabuteau, MD, Chief
Executive Officer of Axsome. “The ability to tackle unmet medical
needs in these serious and difficult-to-treat CNS diseases,
underscores the importance of our novel investigational medicines.
As we move towards the submission of two NDAs in the fourth
quarter, one for AXS-05 in depression and one for AXS-07 in
migraine, our commercial team is focused on launch-readiness
activities to ensure successful commercial execution. In parallel,
we look to continue the momentum in our other late-stage
development programs, including AXS-05 in Alzheimer’s disease
agitation, for which we intend to meet with the FDA after the
recently announced positive ADVANCE-1 pivotal trial results in this
indication, and AXS-12 in narcolepsy, for which we remain on track
to initiate Phase 3 trials later this year.”
CNS Pipeline Update
Axsome is developing a portfolio of
differentiated, patent-protected, central nervous system (CNS)
product candidates. For the many people facing unsatisfactory
treatments for CNS disorders, Axsome accelerates the invention and
adoption of life-changing medicines. The Company’s CNS pipeline
includes four differentiated product candidates in active clinical
development.
- AXS-05: AXS-05
(dextromethorphan/bupropion modulated delivery tablet) is Axsome’s
novel, oral, investigational NMDA receptor antagonist with
multimodal activity being developed for the following indications:
major depressive disorder (MDD), treatment resistant depression
(TRD), Alzheimer’s disease (AD) agitation, and smoking cessation.
AXS-05 has been granted U.S. Food and Drug Administration (FDA)
Breakthrough Therapy designation for the treatment of MDD and Fast
Track designations for the treatment of TRD and for the treatment
of AD agitation.Depression: Axsome remains on
track to submit a New Drug Application (NDA) for AXS-05 in MDD to
the FDA in the fourth quarter of 2020. The NDA is supported by
positive efficacy results from the ASCEND and GEMINI trials. A
Phase 3, open-label, long-term safety extension study of AXS-05 in
patients with MDD and TRD is ongoing to further support the NDA
filing. To date, more than 800 patients have been dosed in this
trial.In March 2020, Axsome announced results from the Phase 3
STRIDE-1 study, a randomized, double-blind, active-controlled,
multicenter, U.S. trial, in patients with confirmed TRD. In this
study, AXS-05 met key secondary endpoints by rapidly and
statistically significantly improving symptoms of depression as
compared to the active comparator bupropion. A second Phase 3 trial
of AXS-05 in TRD is planned for the third quarter of
2020.AD Agitation: In April 2020, Axsome announced
positive results from the Phase 2/3 ADVANCE-1 study, a randomized,
double-blind, controlled, multicenter, U.S. trial in patients with
AD agitation. In this study, AXS-05 met the primary endpoint by
rapidly, substantially, and statistically significantly improving
agitation in patients with AD as compared to placebo. Axsome
intends to meet with the FDA to discuss these results and next
steps in this development program.Smoking
Cessation: Axsome plans to meet with the FDA in the second
half of 2020 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.
- AXS-07: AXS-07
(MoSEIC™ meloxicam/rizatriptan) is Axsome’s novel, oral, rapidly
absorbed, multi-mechanistic, investigational medicine for the acute
treatment of migraine.Migraine: Axsome remains on
track to submit an NDA for AXS-07 in the acute treatment of
migraine to the FDA in the fourth quarter of 2020. The NDA is
supported by positive efficacy results from the MOMENTUM and
INTERCEPT trials. A Phase 3, open-label, long-term safety extension
study of AXS-07 is ongoing to further support the NDA filing. To
date, more than 700 patients have been dosed in this trial.In April
2020, Axsome announced positive results from the Phase 3 INTERCEPT
study, a randomized, double-blind, placebo-controlled, multicenter,
U.S. trial, in the early treatment of migraine. In this study,
AXS-07 met the two co-primary endpoints resulting in significantly
greater rates of freedom from migraine pain and most bothersome
migraine-associated symptoms as compared to placebo. AXS-07 also
substantially and significantly prevented progression of migraine
pain intensity.
- AXS-12: AXS-12
(reboxetine) is Axsome’s novel, oral, potent, and highly selective
norepinephrine reuptake inhibitor for the treatment of narcolepsy.
AXS-12 has been granted Orphan Drug Designation by the FDA for the
treatment of narcolepsy.Narcolepsy: Axsome is on
track to initiate Phase 3 trials of AXS-12 in the treatment of
narcolepsy in the second half of 2020. Axsome previously announced
positive results from the Phase 2 CONCERT study, in which AXS-12
significantly reduced the number of cataplexy attacks and excessive
daytime sleepiness as compared to placebo in patients with
narcolepsy.
- AXS-14: AXS-14
(esreboxetine) is Axsome’s novel, oral, potent, and highly
selective norepinephrine reuptake inhibitor for the treatment of
fibromyalgia. Esreboxetine, the SS-enantiomer of reboxetine, is
more potent and selective than racemic
reboxetine.Fibromyalgia: Axsome plans to meet with
the FDA in the second half of 2020 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 a Phase 2 trial
in the treatment of fibromyalgia.
Anticipated Milestones
- NDA
Submissions: • AXS-05 in the treatment of MDD
(4Q 2020) • AXS-07 in the acute treatment of migraine
(4Q 2020)
- FDA
Meetings: • AXS-14 for fibromyalgia (2H
2020) • AXS-05 for smoking cessation (2H 2020)
- Clinical Trial
Initiations: • Phase 3 trial of AXS-05 in TRD
(3Q 2020) • Phase 3 trials of AXS-12 in narcolepsy (2H
2020) • Phase 3 trial of AXS-05 in Alzheimer’s disease
agitation (2H 2020)
First Quarter 2020 Financial
Results
- Research and development
(R&D) expenses: R&D expenses were $27.5 million
for the quarter ended March 31, 2020 and $7.6 million for the
comparable period in 2019. R&D expense in the quarter included
a one-time charge of $10.2 million for the Pfizer license
agreement, of which $7.2 million was non-cash related. The
remaining increase was due primarily to ongoing spend for our
active clinical trials in the quarter which included the STRIDE-1,
ADVANCE-1, and INTERCEPT trials, close-out costs for our previously
completed GEMINI, MOMENTUM, and CONCERT trials, along with costs
associated with the AXS-05 and AXS-07 open-label safety
studies.
- General and administrative
(G&A) expenses: G&A expenses were $5.0 million for
the quarter ended March 31, 2020 and $2.8 million for the
comparable period in 2019. The change was primarily due to
personnel costs, mainly associated with an increase in stock
compensation expense, along with the build-out of the commercial
function.
- Net loss: Net loss
was $32.5 million, or $(0.88) per share for the quarter ended March
31, 2020, compared to a net loss of $10.6 million, or $(0.32) per
share for the comparable period in 2019.
- Cash: At March 31,
2020, Axsome had $197.3 million of cash compared to $220.0 million
of cash at December 31, 2019.
- Shares
outstanding: At March 31, 2020, Axsome had 37,075,422
shares of common stock outstanding.
- Financial
guidance: Axsome believes that its cash at March 31, 2020
will be sufficient to fund the company’s anticipated operations,
based on its current operating plans, for at least two years.
Conference Call Information
Axsome will host a conference call and webcast
with slides today at 8:00 AM Eastern to discuss first quarter 2020
financial results as well as to provide a corporate update. To
participate in the live conference call, please dial (833) 579-0911
(toll-free domestic) or (778) 560-2804 (international), and use the
conference ID 4088615. 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), treatment resistant
depression (TRD), Alzheimer’s disease (AD) agitation, and as
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, FDA’s agreement with the Company’s
discontinuation of the bupropion treatment arm of the ADVANCE-1
study in accordance with the independent data monitoring
committee’s recommendations); the potential for the MOMENTUM
clinical trial to provide a basis for approval of AXS-07 for the
acute treatment of migraine in adults with or without aura,
pursuant to our special protocol assessment; 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 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 Therapeutics,
Inc.Selected Consolidated Financial
Data
Statements of Operations Information:
|
|
Three months ended |
|
|
March 31, |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
27,521,400 |
|
|
$ |
7,603,081 |
|
General and administrative |
|
|
4,970,057 |
|
|
|
2,818,392 |
|
Total operating expenses |
|
|
32,491,457 |
|
|
|
10,421,473 |
|
Loss from operations |
|
|
(32,491,457 |
) |
|
|
(10,421,473 |
) |
Interest income (expense) |
|
|
7,311 |
|
|
|
(218,903 |
) |
Net loss |
|
$ |
(32,484,146 |
) |
|
$ |
(10,640,376 |
) |
Net loss per common share,
basic and diluted |
|
$ |
(0.88 |
) |
|
$ |
(0.32 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
37,061,356 |
|
|
|
33,052,468 |
|
|
|
|
|
|
|
|
|
|
Balance Sheet Information:
|
March 31, 2020 |
|
|
December 31, 2019 |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
197,313,408 |
|
|
$ |
219,966,167 |
|
Total assets |
|
197,800,871 |
|
|
|
220,549,760 |
|
Loan payable, current and
long-term |
|
20,112,570 |
|
|
|
19,934,918 |
|
Accumulated deficit |
|
(208,379,639 |
) |
|
|
(175,895,493 |
) |
Stockholders’ equity |
$ |
156,156,866 |
|
|
$ |
178,722,389 |
|
|
|
|
|
|
|
|
|
Axsome Contact: Mark Jacobson Chief Operating
Officer 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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