Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage
biopharmaceutical company developing novel therapies for the
management of central nervous system (CNS) disorders, today
reported financial results for the third quarter ended September
30, 2019.
“So far this year, we have significantly
advanced our pipeline of differentiated investigational medicines
that have the potential to transform the lives of many of the
millions of people living with difficult-to-treat CNS disorders.
Our three CNS product candidates in active clinical development are
being evaluated in six efficacy trials, including five Phase 3
trials and one Phase 2 trial, across five different indications,”
said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “It
is an exciting time for Axsome and a potentially important time for
patients and clinicians as all these studies are fast approaching
completion. Specifically, topline readouts from the GEMINI Phase 3
trial of AXS-05 in major depressive disorder, the MOMENTUM Phase 3
trial of AXS-07 in the acute treatment of migraine, and the CONCERT
Phase 2 trial of AXS-12 in narcolepsy are all expected before year
end. We are also concluding patient screening in the Phase 3
STRIDE-1 trial of AXS-05 in treatment resistant depression at the
end of this month, allowing for a meaningful proportion of patients
from this trial to be included in the long-term safety database
which is required for an NDA filing. As a result, topline data from
this trial are now expected in the first quarter of 2020. Also
anticipated next year are topline results from the Phase 2/3
ADVANCE-1 trial of AXS-05 in Alzheimer’s disease agitation in the
first half of 2020 and, importantly, potentially two NDA filings,
for AXS-05 in major depressive disorder and for AXS-07 in the acute
treatment of migraine, in the second half of 2020.”
CNS Pipeline Update
Axsome is developing a portfolio of
differentiated, patent-protected, central nervous system (CNS)
product candidates. CNS disorders are distressing for patients,
difficult to treat, and underserved. Axsome accelerates the
development of new CNS medicines by utilizing proprietary
technologies and novel mechanisms of action, combined with human
proof-of-concept data and innovative clinical trial designs.
Axsome’s technologies include metabolic inhibition, MoSEIC™
delivery, chiral chemistry and formulation, and proprietary
chemical synthesis and analysis. The Company’s CNS pipeline
includes three 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:
treatment resistant depression (TRD), 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 designation for the treatment of MDD and Fast
Track designations for the treatment of TRD and for the treatment
of AD agitation.Depression: Enrollment in the
GEMINI Phase 3 placebo-controlled trial of AXS-05 in MDD has been
completed. Axsome remains on track to report topline results from
GEMINI in the fourth quarter of 2019.Patient screening in the
STRIDE-1 Phase 3 active-controlled trial of AXS-05 in TRD will
conclude at the end of November, with topline results from this
trial now expected in the first quarter of 2020, versus previous
guidance of the fourth quarter of 2019. Screening in STRIDE-1 was
continued beyond the target enrollment number in order to build the
safety database of MDD and TRD patients required for an NDA filing.
To date, approximately 300 patients have been randomized into the
STRIDE-1 trial.Based on the outcome of Axsome’s FDA Breakthrough
Therapy meeting held earlier this year, positive results from
either GEMINI or STRIDE-1 would be sufficient, along with the
previously completed ASCEND trial of AXS-05 in MDD, to support an
NDA filing for AXS-05 for the treatment of MDD, which is targeted
for the second half of 2020.Axsome is also enrolling a Phase 3
open-label, long-term safety extension study of AXS-05 in order to
build the safety database of MDD and TRD patients required for a
potential NDA filing. This open-label safety study is enrolling
patients exiting both the GEMINI and STRIDE-1 trials.AD
Agitation: Axsome is enrolling the ADVANCE-1 study, a
Phase 2/3, randomized, double-blind, controlled, multicenter trial
to evaluate the efficacy and safety of AXS-05 in patients with
Alzheimer’s disease agitation. To date, approximately 70% of the
target number of subjects have been randomized in this trial.
Topline results are anticipated in the first half of
2020.Smoking Cessation: Axsome plans to request a
meeting with the FDA in the first quarter of 2020 to discuss the
continued clinical development of AXS-05 as an aid to smoking
cessation treatment. Earlier in 2019, Axsome reported positive
topline results from a randomized, double-blind, active-controlled
trial of AXS-05 for smoking cessation treatment. The study was
conducted under a research collaboration between Axsome and Duke
University.
- AXS-07: AXS-07
(MoSEIC™ meloxicam/rizatriptan) is Axsome’s novel, oral,
investigational medicine with distinct dual mechanisms of action
for the acute treatment of migraine. The distinct mechanisms and
rapid absorption of MoSEIC™ meloxicam, combined with the known
efficacy of rizatriptan, are designed to enable rapid, superior,
and consistent relief of migraine pain, with lower symptom
recurrence, as compared to currently available
therapies.Migraine: Axsome has completed
enrollment in the MOMENTUM study, a Phase 3, randomized,
double-blind, placebo- and active-controlled, multicenter trial to
evaluate the efficacy and safety of AXS-07 in the acute treatment
of migraine. MOMENTUM is enrolling only patients with a history of
inadequate response to prior acute migraine treatments, assessed
using the Migraine Treatment Optimization Questionnaire (mTOQ-4),
and incorporates the potent active comparator rizatriptan. Axsome
remains on track to report topline results from the MOMENTUM trial
in the fourth quarter of 2019.MOMENTUM is being conducted pursuant
to an FDA Special Protocol Assessment (SPA). Based on FDA feedback,
this trial, if positive, will be the only efficacy trial required
to support an NDA filing for AXS-07 for the acute treatment of
migraine, which is targeted for the second half of 2020.In October
2019, Axsome announced results of the MINDSET physician survey,
which demonstrated a significant unmet need for more efficacious
acute migraine treatments and a high willingness of physicians to
prescribe AXS-07 should it meet the objectives of the ongoing
MOMENTUM Phase 3 trial in patients with difficult-to-treat
migraines.In October 2019, Axsome initiated the INTERCEPT trial, a
Phase 3, randomized, double-blind, multicenter, placebo-controlled
study evaluating the early treatment of migraine with AXS-07. In
the INTERCEPT study, approximately 300 patients will be randomized
in a 1:1 ratio to treatment with AXS-07 or placebo. In contrast to
the MOMENTUM trial, in which patients with a history of inadequate
response treat migraine attacks once they have become of moderate
or severe intensity, patients in the INTERCEPT trial are to
administer AXS-07 at the earliest sign of migraine pain. INTERCEPT
is designed to enhance the market readiness of AXS-07 by generating
additional information on its potential real-world use. Topline
results from INTERCEPT are anticipated in the first quarter of
2020.Axsome is also enrolling a Phase 3 open-label, long-term
safety extension study of AXS-07 in order to build the safety
database required for a potential NDA filing. This open-label
safety study is enrolling patients exiting both the MOMENTUM and
INTERCEPT trials.
- 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 has
completed enrollment in the CONCERT study, a Phase 2, randomized,
double-blind, placebo-controlled, crossover, multicenter trial of
AXS-12 in patients with narcolepsy. Eligible patients are
randomized to receive either AXS-12 followed by placebo, or placebo
followed by AXS-12. Efficacy assessments include the frequency of
cataplexy attacks and measures of other symptoms of narcolepsy.
Axsome remains on track to report topline results from CONCERT in
the fourth quarter of 2019.
Scientific Meeting
Presentations
- International Headache
Society (IHC): In September 2019, Axsome presented results
from a Phase 1 pharmacokinetic trial of AXS-07 at the 19th Congress
of the International Headache Society, held in Dublin, Ireland. The
poster presentation also included information on the design and
targeted patient population of the ongoing MOMENTUM Phase 3
trial.
Corporate Update
- In August 2019, Axsome announced
the appointment of Dave Marek as Chief Commercial Officer,
effective August 31, 2019. Prior to joining Axsome, Mr. Marek was
Vice President, and General Manager of Amgen’s Neuroscience
business unit. Previously, he held executive positions at WebMD and
at Saatchi & Saatchi Healthcare Advertising. Mr. Marek began
his career at Eli Lilly and Company, followed by AstraZeneca.
Anticipated
Milestones
- Clinical Trial Readouts:
- Phase 3 GEMINI trial of AXS-05 in MDD, topline data (4Q
2019)
- Phase 3 MOMENTUM trial of AXS-07 in migraine, topline data (4Q
2019)
- Phase 2 CONCERT trial of AXS-12 in narcolepsy, topline data (4Q
2019)
- Phase 3 STRIDE-1 trial of AXS-05 in TRD, topline data (1Q
2020)
- Phase 3 INTERCEPT trial of AXS-07 in migraine, topline data (1Q
2020)
- Phase 2/3 ADVANCE-1 trial of AXS-05 in AD agitation, topline
data (1H 2020)
- NDA Filings:
- AXS-05 in the treatment of MDD (2H 2020)
- AXS-07 in the acute treatment of migraine (2H 2020)
Upcoming Migraine Key Opinion Leaders
Conference Call and Webcast
Axsome will host an investor R&D conference
call and webcast on November 25, 2019 with migraine key opinion
leaders (KOLs), focusing on AXS-07 and the unmet needs in the acute
treatment of migraine.
This R&D event will feature presentations
from Dr. Stewart J. Tepper, Professor of Neurology at The Geisel
School of Medicine at Dartmouth, and from Dr. Richard B. Lipton,
Professor and Vice Chair of Neurology, and Director of the
Montefiore Headache Center, at the Albert Einstein College of
Medicine. Additional event details including the agenda and access
information will be provided at a later date.
Third Quarter 2019 Financial
Results
- Research and development (R&D) expenses:
R&D expenses were $15.8 million for the quarter ended September
30, 2019 and $6.0 million for the comparable period in 2018. The
increase was primarily due to trials that were initiated in 2019,
which include the GEMINI, MOMENTUM, INTERCEPT, and CONCERT studies,
along with the AXS-05 and AXS-07 open-label safety studies.
- General and administrative (G&A) expenses:
G&A expenses were $3.1 million for the quarter ended September
30, 2019 and $2.2 million for the comparable period in 2018. The
increase was primarily due to higher stock compensation expense and
personnel costs.
- Net loss: Net loss was $19.1 million, or
$(0.56) per share for the quarter ended September 30, 2019,
compared to a net loss of $8.3 million, or $(0.31) per share for
the comparable period in 2018.
- Cash: At September 30, 2019, Axsome had $43.6
million of cash compared to $53.8 million of cash at June 30,
2019.
- Shares outstanding: At September 30, 2019,
Axsome had 34,496,846 shares of common stock outstanding.
Financial Guidance
- R&D expenses are anticipated to decrease in subsequent
quarters reflecting the conclusion of ongoing trials and the
completion of initiation of new trials.
- Axsome believes that its cash at September 30, 2019 will be
sufficient to fund the company’s anticipated operations, based on
its current operating plans, into the second quarter of 2021.
- Axsome currently does not anticipate new equity financings
prior to the readout from its Phase 3 trials, as previously
disclosed.
Conference Call Information
Axsome will host a conference call and webcast
today at 8:00 AM Eastern to discuss third quarter 2019 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 3389043. 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 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
two Phase 3 trials for the acute treatment of migraine. AXS-12 is
currently in a Phase 2 trial in narcolepsy. AXS-05, 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 (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 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, including the Company’s anticipated cash runway and
the Company’s current expectations regarding its plans for future
equity financings prior to the readout from its Phase 3 trials; 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 |
|
September 30, |
|
2019 |
|
2018 |
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
15,835,573 |
|
$ |
6,040,780 |
|
|
|
|
|
|
General and administrative |
|
3,1111,662 |
|
|
2,202,679 |
|
|
|
|
|
|
Total operating expenses |
|
18,947,235 |
|
|
8,243,459 |
|
|
|
|
|
|
Loss from operations |
|
(18,947,235) |
|
|
(8,243,459) |
|
|
|
|
|
|
Interest and amortization of
debt discount (expense) |
|
(327,825) |
|
|
(270,933) |
Tax Credit |
|
139,448 |
|
|
217,418 |
Change in fair value of
warrant liability |
|
— |
|
|
15,000 |
|
|
|
|
|
|
Net loss |
$ |
(19,135,612) |
|
$ |
(8,281,974) |
|
|
|
|
|
|
Net loss per common share,
basic and diluted |
$ |
(0.56) |
|
$ |
(0.31) |
Weighted average common shares
outstanding, basic and diluted |
|
34,445,489 |
|
|
26,325,904 |
Balance Sheet Information:
|
September 30, 2019 |
|
December 31, 2018 |
Cash |
$ |
43,641,861 |
|
$ |
13,968,742 |
Total assets |
|
44,439,729 |
|
|
15,379,279 |
Loan payable, current and
long-term |
|
19,756,667 |
|
|
6,910,814 |
Accumulated deficit |
|
(151,088,509) |
|
|
(107,550,307) |
Stockholders’ equity |
$ |
6,822,596 |
|
$ |
937,921 |
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
Axsome Therapeutics (NASDAQ:AXSM)
Historical Stock Chart
From Mar 2024 to Apr 2024
Axsome Therapeutics (NASDAQ:AXSM)
Historical Stock Chart
From Apr 2023 to Apr 2024