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Axsome Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update
Two NDA submissions, for AXS-05 in MDD and for AXS-07 in migraine, on track for 4Q 2020
Enrollment completed for both the AXS-05 Phase 3 long-term safety trial
in MDD, and for the AXS-07 Phase 3 long-term safety trial in migraine
Results
from three Phase 2 open-label efficacy trials of AXS-05 in TRD,
antidepressant unresponsive MDD, and suicidal ideation, expected in 4Q
2020
Phase 3 trials for AXS-05 in Alzheimer’s disease agitation and for AXS-12 in narcolepsy on track for 4Q 2020
Three
FDA Breakthrough Therapy designations, in MDD, Alzheimer’s disease
agitation, and narcolepsy, highlight Axsome’s broad, differentiated,
late-stage CNS pipeline
Company to host conference call today at 8:00 AM Eastern
NEW
YORK, Aug. 10, 2020 (GLOBE NEWSWIRE) -- 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