Axsome Therapeutics Reports First Quarter 2017 Financial Results
May 09 2017 - 7:00AM
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 quarter ended March 31, 2017.
“In the first quarter we continued to advance
all of our clinical programs, which include three ongoing Phase 3
trials with our lead product candidates AXS-02 and AXS-05,” said
Herriot Tabuteau, M.D., Chief Executive Officer of Axsome. “The
recently completed common stock offering bolsters our balance sheet
and provides the financial resources to maintain our pipeline
momentum.”
Pipeline Update
Axsome is developing a portfolio of
differentiated, patent-protected, CNS product candidates. CNS
disorders are distressing, difficult-to-treat, and underserved with
many having no approved or satisfactory treatments. Axsome
accelerates the development of new CNS medicines in a
cost-efficient manner, by utilizing novel mechanisms of action and
novel delivery approaches of well-characterized molecules, combined
with human proof-of-concept data and innovative clinical trial
designs. Our pipeline includes two late-stage product candidates in
Phase 3 development and preclinical candidates.
- AXS-05: Axsome is developing AXS-05 (bupropion
and dextromethorphan fixed-dose combination) in two separate Phase
3 clinical programs for treatment resistant depression (TRD) and
Alzheimer’s disease (AD) agitation.TRD: In
February 2017, the U.S. Food and Drug Administration (FDA) granted
Axsome Fast Track designation for AXS-05 for TRD. Axsome is
enrolling the STRIDE-1 study, a Phase 3, multicenter, randomized,
double-blind, active-controlled trial to assess the efficacy and
safety of AXS-05 in TRD, defined as major depressive disorder which
has failed to respond to two or more antidepressant
treatments.AD Agitation: In May 2017, the FDA
granted Axsome Fast Track designation for AXS-05 for the treatment
of AD agitation. In January 2017, Axsome received Investigational
New Drug Application (IND) clearance from the FDA to proceed with a
Phase 2/3 trial of AXS-05 in this indication. Axsome anticipates
commencing this trial in the second quarter of 2017.
- AXS-02: Axsome is developing AXS-02 (disodium
zoledronate tetrahydrate) in three separate Phase 3 clinical
programs: complex regional pain syndrome (CRPS), knee
osteoarthritis (OA) associated with bone marrow lesions (BMLs), and
chronic low back pain (CLBP) associated with Modic changes
(MCs).CRPS: Axsome is enrolling the CREATE-1
study, a global, randomized, double-blind, placebo-controlled Phase
3 clinical trial to assess the efficacy and safety of AXS-02 in the
treatment of pain in patients with CRPS. CREATE-1 incorporates an
interim analysis for efficacy which will be conducted on the first
approximately 95 enrolled subjects.Knee OA associated with
BMLs: Axsome is evaluating AXS-02 in the COAST-1 study, a
global, randomized, double-blind, placebo-controlled Phase 3
clinical trial to assess the efficacy and safety of AXS-02 in the
treatment of the pain of knee OA associated with BMLs. Screening of
subjects in this trial is paused pending results of the interim
analysis on the first approximately 60 subjects enrolled in the
trial to assess the assumptions used to determine the sample size
of the study.CLBP associated with MCs: In February
2017, Axsome received IND clearance from the FDA to proceed with a
Phase 3 trial of AXS-02 in the treatment of CLBP associated with
MCs. The start of this trial is planned following readouts from
Axsome’s ongoing Phase 3 trials in CRPS and TRD.
- Other Programs: Axsome is currently evaluating
additional product candidates, including AXS-06, that it intends to
develop for CNS disorders, including chronic pain.
Corporate Update
- In March 2017, Axsome completed an underwritten public offering
of common stock raising gross proceeds of approximately $16.1
million, which includes full exercise of the underwriter’s option
to purchase additional shares.
Anticipated Near-Term Clinical
Milestones
- Clinical Trial Initiations:-- Phase 2/3
clinical trial of AXS-05 in AD agitation (2Q 2017)
- Clinical Trial Readouts:-- Phase 3 COAST-1
trial of AXS-02 in knee OA associated with BMLs, interim analysis
(3Q 2017)-- Phase 3 CREATE-1 trial of AXS-02 in CRPS, interim
efficacy analysis (4Q 2017)-- Phase 3 STRIDE-1 trial of AXS-05 in
TRD, top-line data (1Q 2018)
First Quarter 2017 Financial Results
- Research and development (R&D) expenses:
R&D expenses were $6.0 million for the quarter ended March 31,
2017 compared to $4.5 million for the comparable period in 2016.
The increase in R&D expenses was primarily due to the conduct
of the CREATE-1, STRIDE-1, and COAST-1 Phase 3 clinical trials, as
well as product candidate manufacturing costs.
- General and administrative (G&A) expenses:
G&A expenses were $1.7 million for the quarter ended March 31,
2017 compared to $1.4 million for the comparable period in 2016.
The increase in G&A expenses was primarily related to stock
compensation expense.
- Net loss: Net loss was $8.0 million, or
$(0.41) per share, for the quarter ended March 31, 2017 compared to
a net loss of $5.9 million, or $(0.31) per share, for the quarter
ended March 31, 2016.
- Cash: As of March 31, 2017, Axsome had $45.0
million of cash compared to $36.6 million of cash as of December
31, 2016.
- Shares outstanding: As of March 31, 2017,
Axsome had 23,543,667 shares of common stock outstanding.
- Financial guidance: Axsome believes that its
cash as of March 31, 2017 will be sufficient to fund the company’s
anticipated operations, based on its current operating plans, into
the first quarter of 2019.
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 product candidate
portfolio includes two late-stage candidates, AXS-05 and AXS-02.
AXS-05 is currently in a Phase 3 trial in treatment resistant
depression (TRD), and a Phase 2/3 trial in agitation in patients
with Alzheimer’s disease (AD) is planned. AXS-02 is currently in
Phase 3 trials in complex regional pain syndrome (CRPS) and knee
osteoarthritis (OA) associated with bone marrow lesions (BMLs) with
an additional Phase 3 trial planned in chronic low back pain (CLBP)
associated with Modic changes (MCs). AXS-05 and AXS-02 are
investigational drug products not approved by the FDA. For more
information, please visit the company website at www.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, interim
analyses and completion of the trials; the timing of and our
ability to obtain and maintain U.S. Food and Drug Administration or
other regulatory authority approval of, or other action with
respect to, our product candidates; 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; 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
(unaudited): |
|
|
|
|
|
Three Months Ended March 31, |
|
|
2017 |
|
2016 |
Operating
expenses: |
|
|
|
|
Research
and development |
|
$ 5,985,219 |
|
$ 4,526,252 |
General
and administrative |
|
1,686,814 |
|
1,356,613 |
Total operating
expenses |
|
7,672,033 |
|
5,882,865 |
|
|
|
|
|
Loss from
operations |
|
(7,672,033) |
|
(5,882,865) |
|
|
|
|
|
Interest and
amortization of debt discount/premium (expense) income |
|
(323,006) |
|
16,924 |
Net loss |
|
$ (7,995,039) |
|
$ (5,865,941) |
Net loss per common
share – basic and diluted |
|
$
(0.41) |
|
$
(0.31) |
Weighted average common
shares outstanding – basic and diluted |
|
19,537,897 |
|
19,149,417 |
|
|
|
|
|
Balance Sheet Information: |
|
|
|
|
|
|
|
March 31, 2017 |
|
December 31, 2016* |
|
|
(unaudited) |
|
|
|
|
Cash |
|
$ |
45,019,627 |
|
|
$ |
36,618,497 |
|
Total assets |
|
|
46,411,558 |
|
|
|
38,212,608 |
|
Loan payable, current
and long-term |
|
|
9,855,252 |
|
|
|
9,739,607 |
|
Accumulated
deficit |
|
|
(55,636,490 |
) |
|
|
(47,641,451 |
) |
Stockholders’
equity |
|
$ |
29,280,480 |
|
|
$ |
21,571,451 |
|
|
|
|
|
|
|
|
|
|
*Condensed
from audited financial statements. |
|
Axsome Contact:
Mark Jacobson
Vice President, Operations
Axsome Therapeutics, Inc.
25 Broadway, 9th Floor
New York, NY 10004
Tel: 212-332-3243
Email: mjacobson@axsome.com
www.axsome.com
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