Axsome Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update
August 10 2020 - 7:05AM
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 second quarter ended June 30, 2020.
“Axsome is committed to developing potentially
life-changing medicines for patients living with difficult-to-treat
CNS disorders. Over the past several months, we achieved a number
of significant clinical and regulatory milestones including receipt
of Breakthrough Therapy designations from the FDA for AXS-05 for
the treatment of Alzheimer’s disease agitation, and for AXS-12 for
the treatment of cataplexy in patients with narcolepsy. Our
industry-leading, late-stage CNS pipeline has now been granted
three FDA Breakthrough Therapy designations, highlighting the
potential for significant advances in patient care,” said Herriot
Tabuteau, MD, Chief Executive Officer of Axsome. “We remain on
track to submit two New Drug Applications to the FDA, for AXS-05 in
depression and for AXS-07 in migraine, by year-end. We expect to
launch the second pivotal trial of AXS-05 in Alzheimer’s disease
agitation as well as pivotal trials of AXS-12 in narcolepsy by year
end. We also unveiled three new Phase 2 open-label efficacy trials
of AXS-05 in three different clinically pertinent depressed
populations. These trials are designed to further characterize the
novel antidepressant profile of AXS-05 across a broad spectrum of
patients with major depressive disorder, with results expected in
the fourth quarter. Having achieved a number of key milestones and
with more on the horizon, our team is expanding to support
launch-readiness efforts and our growing pipeline.”
CNS Pipeline Update
Axsome is developing a portfolio of
differentiated, patent-protected, central nervous system (CNS)
product candidates. For the many people living with serious 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),
Alzheimer’s disease (AD) agitation, and smoking cessation. AXS-05
has been granted U.S. Food and Drug Administration (FDA)
Breakthrough Therapy designations for MDD, and for AD agitation; as
well as Fast Track designations for treatment resistant MDD (TRD),
and for AD agitation.Depression: Axsome remains on
track to submit a New Drug Application (NDA) to the FDA for AXS-05
for the treatment of MDD in the fourth quarter of 2020. In July
2020, Axsome announced it had completed a pre-NDA meeting for
AXS-05 in MDD with the FDA to reach agreement on the proposed
content and format of the Company’s planned NDA submission,
including the clinical and nonclinical requirements. Based on the
feedback from the FDA, the Company believes its regulatory data
package will be sufficient to support an NDA for AXS-05 in MDD. The
NDA is supported by positive efficacy results from the ASCEND and
GEMINI trials.Enrollment has been completed in the COMET (Clinical
Outcomes with NMDA-based Depression Treatment) Phase 3 open-label,
long-term safety trial to support the planned NDA filing of AXS-05
in MDD. Nearly 900 patients have been enrolled, more than 500 of
whom have been treated with AXS-05 for at least 6 months to date.
At least 300 patients treated for 6 months and 100 patients treated
for one year are required for the NDA filing. Axsome remains on
track to achieve the required number of patients treated for one
year in the fourth quarter.Axsome is conducting three Phase 2
open-label efficacy sub-studies of the COMET trial which will
evaluate the efficacy and safety of AXS-05 in three clinically
pertinent MDD patient populations: the COMET-TRD trial in treatment
resistant MDD (TRD), the COMET-AU trial in antidepressant
unresponsive MDD, and the COMET-SI trial in MDD with suicidal
ideation. Efficacy results from these studies are expected in the
fourth quarter of 2020.Axsome has initiated the MERIT (Mechanistic
Evaluation of Response in TRD) trial, a Phase 2, double-blind,
placebo-controlled, randomized withdrawal study in patients with
TRD. Results from the MERIT trial are expected in the first half of
2021. The MERIT and COMET-TRD trials are being conducted in lieu of
the previously planned Phase 3 trial in TRD. This approach will
more quickly generate clinically useful information with AXS-05 in
this treatment resistant MDD population, starting as early as the
fourth quarter of 2020.AD Agitation: In June 2020,
Axsome received FDA Breakthrough Therapy designation for AXS-05 for
the treatment of AD agitation. The designation was supported by the
positive results from the pivotal ADVANCE-1 study, a randomized,
double-blind, controlled, multicenter U.S. trial in which 366
Alzheimer’s disease patients were treated with AXS-05, bupropion,
or placebo. Axsome remains on track to initiate a second Phase 3
trial of AXS-05 in AD agitation in the second half of
2020. 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.Enrollment
has been completed in the MOVEMENT (Multimechanistic Treatment
Overtime of Migraine Symptoms) Phase 3 open-label, long-term safety
trial to support the planned NDA filing of AXS-07 in the acute
treatment of migraine. More than 700 patients have been enrolled,
approximately 450 of whom have been treated with AXS-07 for at
least 6 months to date. At least 300 patients treated for 6 months
and 100 patients treated for one year are required for the NDA
filing. Axsome remains on track to achieve the required number of
patients treated for one year in the third quarter.
- 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
FDA Breakthrough Therapy designation for the treatment of cataplexy
in patients with narcolepsy and Orphan Drug Designation for the
treatment of narcolepsy.Narcolepsy: In August
2020, Axsome received FDA Breakthrough Therapy designation for
AXS-12 for the treatment of cataplexy in patients with narcolepsy.
The designation was supported by the positive results from the
Phase 2 CONCERT study, a randomized, double-blind,
placebo-controlled, crossover, multicenter U.S. trial in which 21
patients with a diagnosis of narcolepsy with cataplexy were treated
with AXS-12 or with placebo, followed by a crossover to the other
treatment. Axsome is on track to initiate Phase 3 trials of AXS-12
in the treatment of narcolepsy in the second half of 2020.
- 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-05 for AD agitation (2H 2020)
- AXS-05 for smoking cessation (2H 2020)
- AXS-12 for narcolepsy (2H 2020)
- AXS-14 for fibromyalgia (2H 2020)
- Clinical Trial Readouts:
- Phase 2 COMET-TRD trial of AXS-05 in TRD, topline data (4Q
2020)
- Phase 2 COMET-AU trial of AXS-05 in antidepressant unresponsive
MDD, topline data (4Q 2020)
- Phase 2 COMET-SI trial of AXS-05 in MDD with suicidal ideation,
topline data (4Q 2020)
- Phase 2 MERIT trial of AXS-05 in TRD, topline data (1H
2021)
- Clinical Trial Initiations:
- Phase 3 trials of AXS-12 in narcolepsy (2H 2020)
- Phase 3 trial of AXS-05 in AD agitation (2H 2020)
Second Quarter 2020 Financial Results
- Research and development (R&D) expenses:
R&D expenses were $10.5 million for the quarter ended June 30,
2020 and $11.0 million for the comparable period in 2019. The
decrease of $0.5 million was driven by the completion of several
clinical trials which were ongoing in the comparable period in
2019.
- General and administrative (G&A) expenses:
G&A expenses were $7.2 million for the quarter ended June 30,
2020 and $2.4 million for the comparable period in 2019. The change
was primarily due to an increase in stock compensation expense,
along with the build-out of the commercial function.
- Net loss: Net loss was $18.3 million, or
$(0.49) per share for the quarter ended June 30, 2020, compared to
a net loss of $13.8 million, or $(0.41) per share for the
comparable period in 2019.
- Cash: At June 30, 2020, Axsome had $190.7
million of cash compared to $197.3 million of cash at March 31,
2020.
- Shares outstanding: At June 30, 2020, Axsome
had 37,267,510 shares of common stock outstanding.
- Financial guidance: Axsome believes that its
cash at June 30, 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
today at 8:00 AM Eastern to discuss second quarter 2020 financial
results as well as to provide a corporate update. To participate in
the live conference call, please dial (844) 698-4029 (toll-free
domestic) or (647) 253-8660 (international), and use the conference
ID 4876676. 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 |
|
|
|
June 30, |
|
|
|
2020 |
|
2019 |
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
$ |
10,542,957 |
|
$ |
11,003,142 |
|
General and administrative |
|
7,235,877 |
|
2,445,077 |
|
Total operating expenses |
|
17,778,834 |
|
13,448,219 |
|
Loss from operations |
|
(17,778,834 |
) |
(13,448,219 |
) |
Interest income (expense) |
|
(548,158 |
) |
(313,995 |
) |
Net loss |
|
$ |
(18,326,992 |
) |
$ |
(13,762,214 |
) |
Net loss per common share, basic
and diluted |
|
$ |
(0.49 |
) |
$ |
(0.41 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
37,100,770 |
|
33,801,749 |
|
Balance Sheet Information:
|
|
|
|
|
|
|
|
|
|
June 30, 2020 |
|
December 31, 2019 |
|
Cash and cash equivalents |
|
$ |
190,682,109 |
|
$ |
219,966,167 |
|
Total assets |
|
190,989,587 |
|
220,549,760 |
|
Loan payable, current and
long-term |
|
20,291,582 |
|
19,934,918 |
|
Accumulated deficit |
|
(226,706,631 |
) |
(175,895,493 |
) |
Stockholders’ equity |
|
$ |
154,243,310 |
|
$ |
178,722,389 |
|
Axsome Contact: Mark Jacobson Chief Operating
Officer Axsome Therapeutics, Inc. 22 Cortlandt Street, 16th Floor
New York, NY 10007 Tel: 212-332-3243 Email: mjacobson@axsome.com
www.axsome.com
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