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 second quarter ended June 30,
2019.
“Over the past four months, we achieved several
important clinical and regulatory milestones which significantly
accelerated the clinical development of our potentially
first-in-class or best-in-class CNS product candidates, with the
aim of improving the lives of millions of patients living with
difficult-to-treat CNS disorders,” said Herriot Tabuteau, MD, Chief
Executive Officer of Axsome. “Following a successful FDA
Breakthrough Therapy meeting, we launched two new clinical trials:
the placebo-controlled GEMINI Phase 3 trial of AXS-05 in major
depressive disorder, and a Phase 3 open-label long-term safety
trial of AXS-05 in patients with major depressive disorder and
treatment resistant depression. We also held a successful
End-of-Phase 2 meeting with the FDA for AXS-07 in the acute
treatment of migraine. Based on this meeting, the ongoing Phase 3
MOMENTUM trial, if successful, will be the only efficacy trial
required to support an NDA filing for AXS-07. These developments
position us to file potentially two NDAs in the second half of next
year, one for AXS-05 in depression and one for AXS-07 in
migraine.”
“The next several months are expected to be
highly active and potentially transformative for Axsome as we look
forward to readouts from the Phase 3 STRIDE-1 trial of AXS-05 in
treatment resistant depression, the GEMINI Phase 3 trial of AXS-05
in major depressive disorder, the Phase 3 MOMENTUM trial of AXS-07
in the acute treatment of migraine, and the Phase 2 CONCERT trial
of AXS-12 in narcolepsy, with all four anticipated before the end
of this year,” continued Dr. Tabuteau. “In addition, recent
financing activities have enabled us to fully fund all ongoing
clinical trials while further extending our cash runway into the
fourth quarter of 2021, well beyond topline data readouts for all
ongoing efficacy trials.”
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 often underserved, with many having no
approved or satisfactory treatment options. Axsome accelerates the
development of new CNS medicines by utilizing proprietary medicinal
chemistry and formulation 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. Our CNS pipeline
includes three differentiated product candidates in active clinical
development.
- AXS-05: AXS-05 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 consists of a proprietary formulation of dextromethorphan
and bupropion and utilizes Axsome’s metabolic inhibition
technology. 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: In June 2019, Axsome
initiated the GEMINI study, a Phase 3, randomized, double-blind,
multicenter, placebo-controlled trial of AXS-05 in patients with
MDD. In the GEMINI study, approximately 300 patients with a
confirmed diagnosis of moderate to severe MDD will be randomized in
a 1:1 ratio to treatment with AXS-05 or placebo. To date,
approximately 30% of the targeted number of patients have been
randomized into this trial. Based on the results of Axsome’s recent
Breakthrough Therapy meeting, the previously completed ASCEND trial
of AXS-05 in MDD is considered pivotal and sufficient with either
the GEMINI trial of AXS-05 in MDD or the STRIDE-1 trial of AXS-05
in TRD, if positive, to support an NDA filing for AXS-05 for the
treatment of MDD, as previously reported. Axsome continues to
expect topline efficacy results from both the STRIDE-1 and GEMINI
trials in the second half of 2019, with an NDA filing anticipated
in the second half of 2020.In July 2019, Axsome initiated 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 the Phase 3 GEMINI trial, as well as patients
exiting the Phase 3 STRIDE-1 trial.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 agitation associated
with AD. To date, just under 60% 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 intends to meet with the FDA later this year to obtain
advice on the continued clinical development of AXS-05 as an aid to
smoking cessation treatment. Axsome previously 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 is
Axsome’s novel, oral, investigational medicine with distinct dual
mechanisms of action being developed for the acute treatment of
migraine. AXS-07 consists of MoSEIC™ meloxicam and rizatriptan. The
distinct mechanism of action 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 is
enrolling 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.
The trial is being conducted pursuant to an FDA Special Protocol
Assessment (SPA), and is enrolling only patients with a history of
inadequate response to prior acute migraine treatments. The
historical inadequate response in this difficult-to-treat
population has been associated with a significantly increased risk
of new-onset chronic migraine, which may be prevented by improving
acute treatment outcomes [1]. In the MOMENTUM trial, patients are
randomized to treatment with AXS-07, rizatriptan, meloxicam, or
placebo. Rizatriptan, the active comparator in the trial, is
considered to be one of the most efficacious oral medications
currently available for the acute treatment of migraine [2].
Superiority of AXS-07 to the rizatriptan and meloxicam arms would
be established based on sustained freedom from headache pain from
two to 24 hours after dosing. The MOMENTUM study continues to
enroll ahead of expectations and, to date, more than 70% of the
target number of subjects in the trial have been randomized. Axsome
continues to expect topline results from this trial in the second
half of 2019.In May 2019, Axsome held an End-of-Phase 2 meeting
with the FDA to discuss the development status and plan for AXS-07
for the acute treatment of migraine. Based on the results of this
meeting, the ongoing MOMENTUM trial, if positive, will be the only
efficacy trial required to support an NDA filing for AXS-07 for the
acute treatment of migraine. A safety database including at least
300 patients treated with AXS-07 for at least six months and at
least 100 patients treated for one year is required for the NDA
filing. Axsome anticipates an NDA filing for AXS-07 in the acute
treatment of migraine in the second half of 2020.In July 2019,
Axsome initiated 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 the Phase 3 MOMENTUM trial.
- AXS-12: AXS-12 is
Axsome’s novel, oral, potent, and highly selective norepinephrine
reuptake inhibitor (reboxetine) being developed for the treatment
of narcolepsy. AXS-12 has been granted Orphan Drug Designation by
the FDA for the treatment of
narcolepsy.Narcolepsy: Axsome is enrolling 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 will include the frequency of
cataplexy attacks and measures of other symptoms of narcolepsy. To
date, randomization in this trial is approaching 50% of the target
number of patients. Axsome continues to expect topline results from
this trial in the second half of 2019.
Corporate Update
- In May 2019, Axsome raised $20.1 million through the sale of
942,285 shares of its common stock under its existing at-the-market
facility with SVB Leerink.
- In July 2019, Axsome was added to the Russell 3000® and Russell
2000® Indexes, as part of the annual Russell indexes
reconstitution.
- In July 2019, Axsome amended its
existing term loan facility agreement, led by Silicon Valley Bank
(SVB), to extend the initial 12-month interest-only payment period
as well as the time for drawing down additional funding under the
loan facility. Axsome entered into the $24 million loan agreement
in March 2019. Under the amendment, the interest-only payment
period is extended by a minimum of six months, to 18 months, which
may be further extended to 24 months should Axsome elect to draw
down an additional $4 million that remains unfunded under the loan
agreement.
Anticipated
Milestones
Ο Phase 3 STRIDE-1
trial of AXS-05 in TRD, topline data (2H 2019)
Ο Phase 3 GEMINI
trial of AXS-05 in MDD, topline data (2H 2019)
Ο Phase 3
MOMENTUM trial of AXS-07 in migraine, topline data (2H 2019)
Ο Phase 2
CONCERT trial of AXS-12 in narcolepsy, topline data (2H 2019)
Ο Phase 2/3
ADVANCE-1 trial of AXS-05 in AD agitation, topline data (1H
2020)
Ο AXS-05 in the
treatment of MDD (2H 2020)Ο AXS-07 in the acute treatment of
migraine (2H 2020)
Upcoming Investor
Conferences
Axsome is scheduled to participate in the
following five upcoming investor conferences over the next two
months:
- BTIG Biotechnology Conference – August 12, 2019, New York, NY
(Not webcasted)
- H.C Wainwright Global Investment Conference – September 8-10,
2019, New York, NY (To be webcasted)
- Morgan Stanley Global Healthcare – September 11, 2019, New
York, NY (To be webcasted)
- Ladenburg Thalmann Healthcare Conference – September 24, 2019,
New York, NY (To be webcasted)
- Cantor Fitzgerald Global Healthcare Conference – October 2-4,
2019, New York, NY (To be webcasted)
The exact timing of these presentations and
associated webcast information will be posted in advance under the
Webcast and Presentations page on the Company’s website at
www.axsome.com.
Second Quarter 2019 Financial
Results
- Research and development (R&D) expenses:
R&D expenses were $11.0 million for the quarter ended June 30,
2019 compared with $5.6 million for the comparable period in 2018.
The increase was primarily due to the significantly
faster-than-expected enrollment in the MOMENTUM trial; the
preparation for and initiation of the GEMINI trial, the AXS-05
open-label safety study, and the AXS-07 open-label safety study;
and continued progress of the STRIDE-1, ADVANCE-1, and CONCERT
trials.
- General and administrative (G&A) expenses:
G&A expenses for the three months ended June 30, 2019 was $2.4
million, which was unchanged compared with the three months ended
June 30, 2018.
- Net loss: Net loss was $13.8 million, or
$(0.41) per share for the quarter ended June 30, 2019, compared
with a net loss of $8.3 million, or $(0.32) per share for the
comparable period in 2018.
- Cash: At June 30, 2019, Axsome had $53.8
million of cash compared with $42.6 million of cash as of March 31,
2019.
- Shares outstanding: At June 30, 2019, Axsome
had 34,330,441 shares of common stock outstanding.
Financial Guidance
- R&D expenses are anticipated to decrease in subsequent
quarters reflecting the completion of initiation of new trials, and
the conclusion of ongoing trials.
- Axsome believes that its cash at June 30, 2019 will be
sufficient to fund the company’s anticipated operations, based on
its current operating plans, into the fourth quarter of 2021.
- As previously disclosed in June 2019, Axsome currently does not
anticipate new equity financings prior to the readout from its
Phase 3 trials.
Conference Call Information
Axsome will host a conference call and webcast
today at 8:00 AM Eastern to discuss second 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 4184366. 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 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 (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 |
|
|
June 30, |
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
11,003,142 |
|
|
$ |
5,550,532 |
|
General and administrative |
|
|
2,445,077 |
|
|
|
2,439,061 |
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
13,448,219 |
|
|
|
7,989,593 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(13,448,219 |
) |
|
|
(7,989,593 |
) |
|
|
|
|
|
|
|
|
|
Interest and amortization of
debt discount (expense) |
|
|
(313,995 |
) |
|
|
(292,323 |
) |
Change in fair value of
warrant liability |
|
|
— |
|
|
|
1,000 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(13,762,214 |
) |
|
$ |
(8,280,916 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share,
basic and diluted |
|
$ |
(0.41 |
) |
|
$ |
(0.32 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
33,801,749 |
|
|
|
25,791,177 |
|
Balance Sheet Information:
|
June 30, 2019 |
|
December 31, 2018 |
Cash |
$ |
53,753,137 |
|
$ |
13,968,742 |
Total assets |
|
54,777,766 |
|
|
15,379,279 |
Loan payable, current and
long-term |
|
19,579,743 |
|
|
6,910,814 |
Accumulated deficit |
|
(131,952,897) |
|
|
(107,550,307) |
Stockholders’ equity |
$ |
24,282,945 |
|
$ |
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
References
[1] Lipton RB, Fanning KM, Serrano D, Reed ML, Cady R, Buse DC.
Ineffective acute treatment of episodic migraine is associated with
new-onset chronic migraine. Neurology. 2015 Feb
17;84(7):688-95.
[2] Ferrari MD, Roon KI, Lipton RB, Goadsby PJ. Oral triptans
(serotonin 5-HT(1B/1D) agonists) in acute migraine treatment: a
meta-analysis of 53 trials. Lancet. 2001 Nov
17;358(9294):1668-75.
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