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 fourth quarter and year ended
December 31, 2019.
“Axsome delivered on several transformative
achievements in 2019, including positive NDA-enabling clinical
trial readouts for AXS-05 in depression and for AXS-07 in migraine,
propelling Axsome potentially towards commercial stage as early as
2021,” said Herriot Tabuteau, MD, Chief Executive Officer of
Axsome. “In addition, our AXS-12 product candidate for narcolepsy
achieved positive Phase 2 results and is progressing to Phase 3,
and through our agreement with Pfizer earlier this year, we
expanded our Phase 3 pipeline with the addition of AXS-14 for the
treatment of fibromyalgia.”
Dr. Tabuteau said, “We expect continued
operational momentum in 2020 with the anticipated filing of the two
NDAs for AXS-05 in depression and for AXS-07 in migraine, which we
expect to occur in the fourth quarter. Furthermore, we are on track
for readouts from our STRIDE-1 Phase 3 trial of AXS-05 in treatment
resistant depression and our INTERCEPT Phase 3 trial of AXS-07 in
early treatment of migraine, both by the end of this month. We
expect readouts from our ADVANCE-1 Phase 2/3 trial of AXS-05 in
Alzheimer’s disease agitation in the third quarter. By providing
new mechanisms of action, and potentially faster, greater and
broader efficacy as compared to currently available treatments, our
investigational medicines have the potential to change the current
standard of care for difficult-to-treat CNS disorders and transform
the lives of patients living with these conditions.”
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 disease, 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: In December
2019, Axsome announced positive results from the Phase 3 GEMINI
study, a randomized, double-blind, placebo-controlled, multicenter,
U.S. trial, in patients with confirmed moderate to severe MDD. In
this study, AXS-05 met the primary endpoint by rapidly,
substantially, and statistically significantly improving symptoms
of depression as compared to placebo. The positive results from the
GEMINI trial, along with the previously completed ASCEND trial of
AXS-05 in MDD, support an NDA filing for AXS-05 in the treatment of
MDD, which is anticipated in the fourth quarter of 2020.
Randomization into the STRIDE-1 Phase 3 active-controlled trial of
AXS-05 in TRD has been completed. Axsome remains on track to report
topline results from STRIDE-1 in the first quarter of 2020. To
support the planned NDA filing of AXS-05 in MDD, a Phase 3,
open-label, long-term safety extension study of AXS-05 in patients
with MDD and TRD is ongoing. 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, more than 80% of the target number of subjects
have been randomized in this trial. Based on current enrollment, we
expect topline results from this trial in the third quarter of
2020. Smoking Cessation: Axsome plans to meet
with the FDA in 2020 to discuss the continued clinical development
of AXS-05 as an aid to smoking cessation treatment.
- 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: In December
2019, Axsome announced positive results from the Phase 3 MOMENTUM
study, a randomized, double-blind, placebo- and active-controlled,
multicenter, U.S. trial, in migraine patients with a history of
inadequate response to prior acute treatments. The study
incorporated the potent active comparator rizatriptan. In this
study, AXS-07 met the two regulatory 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 met the key secondary endpoint, demonstrating
statistically significant superiority to the active comparator
rizatriptan on sustained freedom from migraine pain. MOMENTUM was
conducted pursuant to an FDA Special Protocol Assessment (SPA). The
positive results from the MOMENTUM trial support an NDA filing for
AXS-07 in the acute treatment of migraine, which is anticipated in
the fourth quarter of 2020. Enrollment in the Phase 3 INTERCEPT
study, a placebo-controlled trial of AXS-07 in the early treatment
of migraine has been completed. Axsome remains on track to report
topline results from INTERCEPT in the first quarter of 2020.To
support the planned NDA filing of AXS-07 in the acute treatment of
migraine, enrollment in a Phase 3 open-label, long-term safety
extension study of AXS-07 is ongoing.
- 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: In December
2019, Axsome announced positive results from the Phase 2 CONCERT
study, a randomized, double-blind, placebo-controlled, crossover,
multicenter, U.S. trial, of AXS-12 in patients with narcolepsy. In
this study, AXS-12 met the prespecified primary endpoint and
significantly reduced the number of cataplexy attacks as compared
to placebo. AXS-12 also significantly reduced excessive daytime
sleepiness (EDS), and improved cognitive function, sleep quality
and sleep-related symptoms as compared to placebo. Axsome plans to
initiate Phase 3 trials of AXS-12 in the treatment of narcolepsy in
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: In January 2020, Axsome
obtained exclusive U.S. rights from Pfizer, Inc. for the
development and commercialization of AXS-14 (esreboxetine), which
has demonstrated positive and statistically significant results in
a Phase 3 and a Phase 2 trial in the treatment of fibromyalgia. In
a Phase 3 trial conducted by Pfizer in 1,122 patients with
fibromyalgia treated with esreboxetine or placebo for 14 weeks,
esreboxetine met the two primary endpoints demonstrating
statistically significant improvements compared to placebo in the
weekly mean pain score (p<0.001), and the Fibromyalgia Impact
Questionnaire (FIQ) total score (p<0.001). Esreboxetine also
resulted in statistically significant improvements as compared to
placebo in fatigue as measured using the Global Fatigue Index
(p=0.001).Axsome plans to meet with the FDA in 2020 to discuss the
further clinical development of AXS-14 for the treatment of
fibromyalgia.
Corporate Update
- In December 2019, Axsome was added
to the NASDAQ Biotechnology Index®.
- In December 2019, Axsome completed
an underwritten public offering of 2,300,000 shares of its common
stock, including the full exercise of the underwriters’ option to
purchase additional shares, at a public offering price of $87.00
per share. The aggregate gross proceeds to Axsome, before deducting
underwriting discounts and commissions and other estimated offering
expenses, were $200.1 million. SVB Leerink and Morgan Stanley acted
as joint bookrunning managers for the offering.
- In January 2020 Axsome entered into
an agreement with Pfizer Inc. for an exclusive U.S. license to
Pfizer’s clinical and nonclinical data, and intellectual property
for reboxetine, the active pharmaceutical ingredient in AXS-12, and
for exclusive rights to develop and commercialize AXS-14
(esreboxetine), a new product candidate, in the U.S. for the
treatment of fibromyalgia. The agreement accelerates the ongoing
clinical development of AXS-12 in narcolepsy and expands Axsome’s
pipeline of late-stage CNS product candidates.
- In March 2020, Axsome announced the
appointment of Mark Jacobson as Chief Operating Officer, effective
February 28, 2020. Mr. Jacobson has been a member of the Axsome
team since April 2014, and has served as Senior Vice President,
Operations since September 2017.
Anticipated
Milestones
- NDA Filings:
- AXS-05 in the treatment of MDD (4Q 2020)
- AXS-07 in the acute treatment of migraine (4Q 2020)
- Clinical Trial
Readouts:
- 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 (3Q 2020)
- Clinical Trial Initiations:
- Phase 3 trials of AXS-12 in the
treatment of narcolepsy (2H 2020)
Upcoming Investor
Conferences
Axsome is scheduled to participate in the
following upcoming investor conferences over the next two
months:
- William Blair Biotech Focus
Conference – April 2, 2020, New York, NY (Not webcasted)
- Needham Healthcare Conference –
April 14-15, 2020, New York, NY (Not webcasted)
- SunTrust Robinson Humphrey Life
Sciences Summit – May 5-6, 2020, New York, NY (Not webcasted)
Fourth Quarter 2019 Financial Results
- Research and development
(R&D) expenses: R&D expenses were $19.2 million
for the quarter ended December 31, 2019 and $7.2 million for the
comparable period in 2018. This increase was due to a significant
number of new clinical trials that were conducted during the
quarter as compared to the prior year period, including the
CONCERT, GEMINI, MOMENTUM, INTERCEPT trials, and the AXS-05 and
AXS-07 open-label safety studies, in addition to the ongoing
progress of the STRIDE-1 and ADVANCE-1 trials.
- General and administrative
(G&A) expenses: G&A expenses were $5.2 million for
the quarter ended December 31, 2019 and $2.3 million for the
comparable period in 2018. 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 $24.8 million, or $(0.71) per share for the quarter ended
December 31, 2019, compared to a net loss of $9.6 million, or
$(0.32) per share for the comparable period in 2018. Net loss for
the year ended December 31, 2019 was $68.3 million, or $(2.01) per
share, compared to a net loss of $31.0 million, or $(1.15) per
share per share for the comparable period in 2018.
- Cash: At December
31, 2019, Axsome had $220.0 million of cash compared to $14.0
million of cash at December 31, 2018.
- Shares
outstanding: At December 30, 2019, Axsome had 36,933,217
shares of common stock outstanding.
Financial Guidance
- R&D expenses are anticipated to
decrease in subsequent quarters reflecting the conclusion of
ongoing trials.
- Axsome believes that its cash at
December 31, 2019 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 fourth quarter and full year
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 2067997. 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 five clinical-stage candidates,
AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14. AXS-05 is currently in
a Phase 3 trial in treatment resistant depression (TRD), a Phase
2/3 trial in agitation associated with Alzheimer’s disease (AD),
and is being developed for major depressive disorder (MDD). 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 being developed for the treatment of narcolepsy. AXS-14
is being developed for the treatment of 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 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 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; 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 |
|
Twelve months ended |
|
|
|
December 31, |
|
December 31, |
|
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
19,205,271 |
|
$ |
7,151,232 |
|
$ |
53,647,067 |
|
$ |
23,495,055 |
|
General and administrative |
|
5,222,899 |
|
2,299,083 |
|
13,598,030 |
|
9,351,522 |
|
Total operating expenses |
|
24,428,170 |
|
9,450,315 |
|
67,245,097 |
|
32,846,577 |
|
Loss from operations |
|
(24,428,170 |
) |
(9,450,315 |
) |
(67,245,097 |
) |
(32,846,577 |
) |
Interest and amortization of debt
discount (expense) |
|
(378,814 |
) |
(248,700 |
) |
(1,239,537 |
) |
(1,127,305 |
) |
Tax Credit |
|
— |
|
— |
|
139,448 |
|
217,418 |
|
Change in fair value of warrant
liability |
|
— |
|
102.000 |
|
— |
|
2,791,000 |
|
Net loss |
|
$ |
(24,806,984 |
) |
$ |
(9,597,015 |
) |
$ |
(68,345,186 |
) |
$ |
(30,965,464 |
) |
Net loss per common share, basic
and diluted |
|
$ |
(0.71 |
) |
$ |
(0.32 |
) |
$ |
(2.01 |
) |
$ |
(1.15 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
34,757,910 |
|
29,874,410 |
|
34,020,257 |
|
26,883,656 |
|
Balance Sheet Information:
|
|
|
|
|
|
|
|
|
|
December 31, 2019 |
|
December 31, 2018 |
|
Cash and cash equivalents |
|
$ |
219,966,167 |
|
$ |
13,968,742 |
|
Total assets |
|
220,549,760 |
|
15,379,279 |
|
Loan payable, current and
long-term |
|
19,934,918 |
|
6,910,814 |
|
Accumulated deficit |
|
(175,895,493 |
) |
(107,550,307 |
) |
Stockholders’ equity |
|
$ |
178,722,389 |
|
$ |
937,921 |
|
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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