Axsome Therapeutics Reports Second Quarter 2017 Financial Results
09 August 2017 - 9:00PM
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 June 30, 2017.
“We continued our forward momentum in the second
quarter with the expansion of our clinical programs as well as our
team,” said Herriot Tabuteau, M.D., Chief Executive Officer of
Axsome. “Our clinical pipeline now consists of three late-stage
product candidates: AXS-02, AXS-05, and AXS-06. We look forward to
the remainder of the year as we approach results from our ongoing
Phase 3 clinical trials.”
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 product candidates in Phase 3
development, one candidate which we believe to be Phase 3-ready,
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: 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. Approximately 435 patients will be
randomized in a 1:1:1 ratio to receive AXS-05, bupropion, or
placebo for 5 weeks. The primary efficacy measure is the
Cohen-Mansfield Agitation Inventory (CMAI). ADVANCE-1 incorporates
a planned interim analysis to assess the assumptions used to
determine the sample size of the study.
- 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. An interim
analysis will be conducted on the first approximately 60 subjects
enrolled in the trial to assess the assumptions used to determine
the sample size of the study. Screening of new subjects in this
trial is paused pending the results of the interim analysis.
- 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. Meloxicam is a
long-acting NSAID with COX-2 preferential inhibition and potent
pain relieving efficacy. However standard meloxicam has an extended
time to maximum plasma concentration (Tmax) which delays its onset
of action. AXS-06 utilizes Axsome’s proprietary MoSEIC™ (Molecular
Solubility Enhanced Inclusion Complex) technology to substantially
increase the solubility and speed the absorption of meloxicam while
maintaining durability of action. AXS-06 also incorporates
esomeprazole, a proton pump inhibitor, to reduce the risk of NSAID
associated gastrointestinal ulcers which can occur with chronic
NSAID use.Phase 1 Trial Results: In July 2017,
Axsome announced positive topline clinical trial results from a
Phase 1 pharmacokinetic study of AXS-06. The study compared the
pharmacokinetics of meloxicam and esomeprazole after oral
administration of AXS-06 tablets (meloxicam 15 mg, esomeprazole 40
mg), and commercially available Mobic® tablets (15 mg meloxicam)
and Nexium® capsules (40 mg esomeprazole) in healthy volunteers.
The median Tmax for meloxicam, the trial’s primary endpoint, was 9
times faster for AXS-06 as compared to Mobic® (0.5 hour versus 4.5
hours for AXS-06 and Mobic®, respectively, p<0.0001). AXS-06
also demonstrated higher mean maximum plasma concentration (Cmax)
(p=0.0018), faster time to therapeutic plasma concentration
(p<0.0001), and time to half-maximal plasma concentration
(p<0.0001) as compared to Mobic®. Terminal half-lives for
meloxicam were similar for AXS-06 and Mobic®. Plasma concentrations
and terminal half-lives of esomeprazole after AXS-06 and Nexium®
administration were comparable.Pre-IND Guidance:
In July 2017, Axsome received, from the FDA, Pre-Investigational
New Drug Application (Pre-IND) written guidance on a proposed
clinical developmental program for AXS-06 for the relief of the
signs and symptoms of OA and RA, and the reduction in the risk of
developing upper gastrointestinal ulcers in patients at risk of
developing NSAID associated upper gastrointestinal ulcers. Based on
this guidance, Axsome believes that AXS-06 is Phase 3-ready.
Corporate Update
- 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.
- In June 2017, Myrtle Potter was appointed to Axsome’s Board of
Directors. Ms. Potter is the Chief Executive Officer and Founder of
Myrtle Potter & Company, a healthcare and life science advisory
firm. Ms. Potter previously served as the President, Commercial
Operations and Chief Operating Officer of Genentech, and held
executive operating positions at Bristol-Myers Squibb and
Merck.
Anticipated Near-Term Clinical
Milestones
- 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)
Second Quarter 2017 Financial
Results
- Research and development (R&D) expenses:
R&D expenses were $5.0 million for the quarter ended June 30,
2017 compared to $5.3 million for the comparable period in 2016.
The decrease in R&D expenses 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 with
AXS-05 and the conduct of the AXS-06 Phase 1 trial.
- General and administrative (G&A) expenses:
G&A expenses were $1.7 million for the quarter ended June 30,
2017 compared to $1.5 million for the comparable period in 2016.
The increase in G&A expenses was primarily due to higher
intellectual property and stock compensation expenses.
- Net loss: Net loss was $7.1 million, or
$(0.30) per share, for the quarter ended June 30, 2017 compared to
a net loss of $6.8 million, or $(0.36) per share, for the quarter
ended June 30, 2016.
- Cash: As of June 30, 2017, Axsome had $38.0
million of cash compared to $36.6 million of cash as of December
31, 2016.
- Shares outstanding: As of June 30, 2017,
Axsome had 23,608,084 shares of common stock outstanding.
- Financial guidance: Axsome believes that its
cash as of June 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 Ended June 30, |
Six Months Ended June 30, |
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
5,007,361 |
|
|
$ |
5,298,060 |
|
|
$ |
10,992,580 |
|
|
$ |
9,824,312 |
|
|
General and administrative |
|
1,743,377 |
|
|
|
1,529,220 |
|
|
|
3,430,191 |
|
|
|
2,885,833 |
|
|
Total operating
expenses |
|
6,750,738 |
|
|
|
6,827,280 |
|
|
|
14,422,771 |
|
|
|
12,710,145 |
|
|
Loss from
operations |
|
(6,750,738 |
) |
|
|
(6,827,280 |
) |
|
|
(14,422,771 |
) |
|
|
(12,710,145 |
) |
|
Interest and
amortization of debt discount/premium (expense) income |
|
(333,578 |
) |
|
|
15,090 |
|
|
|
(656,584 |
) |
|
|
32,014 |
|
|
Net loss |
$ |
(7,084,316 |
) |
|
$ |
(6,812,190 |
) |
|
$ |
(15,079,355 |
) |
|
$ |
(12,678,131 |
) |
|
Net loss per common
share – basic and diluted |
$ |
(0.30 |
) |
|
$ |
(0.36 |
) |
|
$ |
(0.70 |
) |
|
$ |
(0.66 |
) |
|
Weighted average common
shares outstanding – basic and diluted |
|
23,595,702 |
|
|
|
19,149,417 |
|
|
|
21,578,011 |
|
|
|
19,149,417 |
|
|
Balance Sheet Information:
|
|
June 30, 2017 |
|
|
|
December 31, 2016* |
|
|
|
(unaudited) |
|
|
|
|
|
Cash |
$ |
37,994,449 |
|
|
$ |
36,618,497 |
|
Total assets |
|
39,042,861 |
|
|
|
38,212,608 |
|
Loan payable, current
and long-term |
|
9,972,858 |
|
|
|
9,739,607 |
|
Accumulated
deficit |
|
(62,720,806 |
) |
|
|
(47,641,451 |
) |
Stockholders’
equity |
$ |
22,754,608 |
|
|
$ |
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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