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 September 30,
2017.
“In the third quarter we launched our Phase 2/3
ADVANCE-1 trial of AXS-05 in Alzheimer’s disease agitation and
reported positive Phase 1 trial results with our new clinical-stage
product candidate, AXS-06,” said Herriot Tabuteau, M.D., Chief
Executive Officer of Axsome. “We are very excited to be advancing a
broad portfolio of differentiated product candidates for important
clinical indications. Specifically, we are nearing the interim
efficacy results of the CREATE-1 trial of AXS-02 in complex
regional pain syndrome, as well as the interim assessment of sample
size assumptions of the COAST-1 trial of AXS-02 in knee
osteoarthritis associated with bone marrow lesions. With the
addition of AXS-06, our portfolio now includes two non-opioid
candidates for pain.”
Pipeline Update
Axsome is developing a portfolio of
differentiated, patent-protected, central nervous system (CNS)
product candidates. CNS disorders are distressing and
difficult-to-treat. The patients with them are often underserved
with many having no approved or satisfactory treatment options.
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 product candidates in Phase 3
development, one candidate which we believe to be Phase 3-ready,
and additional preclinical candidates.
• AXS-05: Axsome is evaluating
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. AXS-05 is
a novel fixed-dose combination of dextromethorphan (an NMDA
receptor antagonist, sigma-1 receptor agonist, and serotonin and
norepinephrine reuptake inhibitor) and bupropion (a norepinephrine
and dopamine reuptake inhibitor, which also increases the
bioavailability of dextromethorphan), under development for the
treatment of CNS disorders.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 July 2017,
Axsome announced enrollment of the first patient in the ADVANCE-1
study, a Phase 2/3, multicenter, randomized, double-blind,
controlled trial to evaluate the efficacy and safety of AXS-05 in
patients with agitation associated with AD.
• AXS-02: Axsome is evaluating
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).
AXS-02 is a potent osteoclast inhibitor being developed as an oral,
non-opioid, targeted, potentially first-in-class therapeutic for
chronic pain.
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 performed by an independent data monitoring committee
(IDMC) and results of the analysis are expected late December 2017
to early January 2018. Approaching the interim analysis,
approximately 85 subjects have been randomized to date. Enrollment
of subjects in the trial is ongoing and will continue through the
interim analysis.
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. An interim analysis to assess
the sample size of the study will be performed by an IDMC on the
first approximately 60 subjects enrolled in the trial. The interim
analysis will be performed by the same IDMC and at the same meeting
as the interim analysis for the CREATE-1 trial.
• AXS-06: Axsome is developing
AXS-06 (MoSEIC™ meloxicam and esomeprazole) for the relief of the
signs and symptoms of OA and Rheumatoid Arthritis (RA), and the
reduction in the risk of developing upper gastrointestinal ulcers
in patients at risk of developing nonsteroidal anti-inflammatory
drug (NSAID) associated upper gastrointestinal ulcers. AXS-06 is an
oral, non-opioid, rapidly-absorbed, once-daily, COX-2 preferential
pain therapeutic with a gastroprotectant.
In July 2017, Axsome announced positive topline
results from a Phase 1 pharmacokinetic study of AXS-06 which
demonstrated, for the first time, rapid achievement of peak plasma
levels of meloxicam after oral administration. The median Tmax for
meloxicam, the trial’s primary endpoint, was 9 times faster for
AXS-06 as compared to commercially available Mobic® (meloxicam)
tablets. Axsome also received, from the FDA, Pre-Investigational
New Drug Application (Pre-IND) written guidance on a proposed
clinical developmental program for AXS-06. Based on this guidance,
Axsome believes that AXS-06 is Phase 3-ready.
Corporate Update
• In September 2017, Cedric O’Gorman, M.D. was
appointed Senior Vice President, Clinical Development and Medical
Affairs. Dr. O’Gorman was previously Vice President of Medical
Affairs at Intra-Cellular Therapies; U.S. medical lead for
psychiatry at Genentech/Roche; and Medical Director, U.S. Medical
Affairs at Pfizer.
• In July 2017, Axsome announced the appointment
of John Golubieski as Chief Financial Officer (CFO) effective
August 4, 2017. Mr. Golubieski was previously CFO of Osmotica
Holdings; CFO of Fougera Pharmaceuticals, the former U.S. business
of Nycomed; Senior Vice President, Financial Planning &
Analysis of King Pharmaceuticals; and Senior Director, Strategic
Analysis in the Worldwide Medicines Group at Bristol-Myers
Squibb.
Anticipated Near-Term Clinical
Milestones
• Clinical Trial Readouts:
- Phase 3 CREATE-1 trial of AXS-02 in CRPS, interim efficacy
analysis (late December 2017 to early January 2018)
- Phase 3 COAST-1 trial of AXS-02 in knee OA associated with
BMLs, interim analysis (late December 2017 to early January
2018)
- Phase 3 STRIDE-1 trial of AXS-05 in TRD, top-line data (1H
2018)
Third Quarter 2017 Financial
Results
• Research and development (R&D)
expenses: R&D expenses were $4.5 million for the
quarter ended September 30, 2017 compared to $5.6 million for the
comparable period in 2016. The decrease in R&D expense was
primarily due to a reduction in the costs of our previously
initiated clinical trials, which was partially offset by the
initiation of our ADVANCE-1 study, pre-clinical costs for AXS-06,
and manufacturing costs associated with our product candidates.
• General and administrative (G&A)
expenses: G&A expenses were $1.8 million for the
quarter ended September 30, 2017 compared to $1.6 million for the
comparable period in 2016. The increase in G&A expenses was
primarily due to higher intellectual property expenses.
• Net loss: Net loss was $6.4
million, or $(0.27) per share, for the quarter ended September 30,
2017 compared to a net loss of $7.2 million, or $(0.38) per share,
for the quarter ended September 30, 2016.
• Cash: As of September 30,
2017, Axsome had $31.7 million of cash compared to $36.6 million of
cash as of December 31, 2016.
• Shares outstanding: As of
September 30, 2017, Axsome had 23,665,532 shares of common stock
outstanding.
• Financial guidance: Axsome
believes that its cash as of September 30, 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 three clinical-stage candidates, AXS-02, AXS-05,
and AXS-06. 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). 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). A Phase 1 trial of AXS-06 has
been completed. AXS-02, AXS-05, and AXS-06 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 EndedSeptember 30, |
|
|
|
Nine Months EndedSeptember 30, |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
$ |
4,471,126 |
|
|
$ |
5,568,777 |
|
|
$ |
15,463,706 |
|
|
$ |
15,393,089 |
|
|
General
and administrative |
|
1,826,290 |
|
|
|
1,639,026 |
|
|
|
5,256,481 |
|
|
|
4,524,859 |
|
|
Total operating
expenses |
|
6,297,416 |
|
|
|
7,207,803 |
|
|
|
20,720,187 |
|
|
|
19,917,948 |
|
|
Loss from
operations |
|
(6,297,416 |
) |
|
|
(7,207,803 |
) |
|
|
(20,720,187 |
) |
|
|
(19,917,948 |
) |
|
Interest and
amortization of debt discount/premium (expense) income |
|
(343,234 |
) |
|
|
13,219 |
|
|
|
(999,818 |
) |
|
|
45,233 |
|
|
Tax credit |
|
207,114 |
|
|
|
0 |
|
|
|
207,144 |
|
|
|
0 |
|
|
Net loss |
$ |
(6,433,536 |
) |
|
$ |
(7,194,584 |
) |
|
$ |
(21,512,891 |
) |
|
$ |
(19,872,715 |
) |
|
Net loss per common
share – basic and diluted |
$ |
(0.27 |
) |
|
$ |
(0.38 |
) |
|
$ |
(0.97 |
) |
|
$ |
(1.04 |
) |
|
Weighted average common
shares outstanding – basic and diluted |
|
23,634,040 |
|
|
|
19,149,906 |
|
|
|
22,270,885 |
|
|
|
19,149,579 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Balance Sheet
Information: |
|
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|
|
|
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|
|
September 30, 2017 |
|
|
|
December 31, 2016* |
|
|
|
(unaudited) |
|
|
|
|
|
Cash |
$ |
31,673,383 |
|
|
$ |
36,618,497 |
|
Total assets |
|
32,618,112 |
|
|
|
38,212,608 |
|
Loan payable, current
and long-term |
|
10,092,481 |
|
|
|
9,739,607 |
|
Accumulated
deficit |
|
(69,154,342 |
) |
|
|
(47,641,451 |
) |
Stockholders’
equity |
$ |
16,839,057 |
|
|
$ |
21,571,451 |
|
|
|
|
|
|
|
|
|
*Condensed from audited financial statements.
Axsome Contact: Mark Jacobson
Senior 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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