Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical
company developing novel therapies for the management of central
nervous system (CNS) disorders, today reported financial results
for the third quarter ended September 30, 2021.
“Over the past several months we have continued
to advance our differentiated late-stage CNS product candidates
aimed at meaningfully improving the lives of patients. FDA review
of our NDA for AXS-05 in depression continues, and the NDA for
AXS-07 in migraine was accepted, positioning Axsome to potentially
commercialize two new treatments in the near to intermediate term
for patients living with these serious CNS disorders,” said Herriot
Tabuteau, MD, Chief Executive Officer of Axsome. “Our commercial
launch preparations are essentially complete and we remain focused
on ensuring timely and successful launches, assuming approvals. The
rest of our rich pipeline continues to progress, highlighted by our
ongoing Phase 3 ACCORD trial of AXS-05 in Alzheimer’s disease
agitation, the recent initiation of our Phase 3 SYMPHONY trial of
AXS-12 in narcolepsy, and the ongoing manufacturing work to support
the planned NDA filing of AXS-14 for fibromyalgia. In addition,
based on FDA Pre-IND meeting guidance, we plan to proceed to a
Phase 2/3 trial of AXS-05 in smoking cessation and expect to
provide timing on initiation of that trial next year.”
Business Update
Axsome is committed to developing products that
meaningfully improve the lives of patients. The Company is
developing a portfolio of differentiated, patent-protected, CNS
product candidates with four in active clinical development.
AXS-05
AXS-05 (dextromethorphan-bupropion) is Axsome’s
novel, oral, investigational NMDA receptor antagonist with
multimodal activity being developed for the following indications:
major depressive disorder (MDD), Alzheimer’s disease (AD)
agitation, and smoking cessation. AXS-05 has been granted U.S. Food
and Drug Administration (FDA) Breakthrough Therapy designations for
MDD and for AD agitation.
-
Depression: Axsome’s New Drug Application (NDA)
for AXS-05 for the treatment of MDD was granted Priority Review and
is currently under review by the FDA. On August 20, 2021, the FDA
informed the Company in a teleconference that its review of the NDA
would not be completed by the Prescription Drug User Fee Act
(PDUFA) target action date of August 22, 2021. The Company was
recently informed of two deficiencies related to analytical methods
in the Chemistry, Manufacturing, and Controls (CMC) section of the
NDA, which must be addressed prior to the FDA taking action on the
NDA. The Company believes these deficiencies are addressable and is
confirming the details of the request with the FDA.
-
Alzheimer’s Disease Agitation: Axsome is
conducting the ACCORD study, a Phase 3, double-blind,
placebo-controlled, multicenter, randomized withdrawal trial to
evaluate the efficacy and safety of AXS-05 in the treatment of
Alzheimer’s disease (AD) agitation. Based on current enrollment
trends, Axsome now anticipates completion of the trial in the first
half of 2023.
-
Smoking Cessation: Axsome has received from the
FDA positive Pre-Investigational New Drug Application (Pre-IND)
meeting written guidance from the FDA on a proposed clinical
developmental plan for dextromethorphan-bupropion as an aid to
smoking cessation. Based on this feedback, Axsome plans to
proceed to a pivotal Phase 2/3 trial in this indication. The
Company intends to provide information on the timing of initiation
of this study in 2022.
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: Axsome’s NDA for AXS-07 for the acute
treatment of migraine was accepted for review by the FDA. The FDA
has set a PDUFA target action date for the NDA of April 30, 2022.
The FDA notified the Company that, due to COVID-19 pandemic-related
travel restrictions, they may be unable to complete a required
inspection of a contract manufacturing facility, located in the
United States, prior to the PDUFA date, and that they will continue
to monitor the public health situation as well as travel
restrictions.
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 FDA Orphan
Drug designation for the treatment of narcolepsy.
-
Narcolepsy: In September 2021, Axsome initiated
the SYMPHONY study, a Phase 3 randomized, multicenter,
double-blind, placebo-controlled, parallel-group trial of AXS-12 in
the treatment of narcolepsy. Enrollment in the trial is progressing
and topline results are anticipated in the first half of 2023.
AXS-14
AXS-14 (esreboxetine) is Axsome’s novel, oral,
potent, and highly selective norepinephrine reuptake inhibitor for
the management of fibromyalgia. Esreboxetine, the SS-enantiomer of
reboxetine, is more potent and selective than racemic
reboxetine.
-
Fibromyalgia: Manufacturing and other activities
related to the planned submission of an NDA for AXS-14 for the
management of fibromyalgia are ongoing. Based on the status of
these activities, the Company now expects to submit the NDA in
2023. AXS-14 has previously met the primary endpoints and
demonstrated positive and statistically significant results in a
Phase 3 and in a Phase 2 trial for the management of
fibromyalgia.
Commercial and Launch-Readiness
Activities
Axsome is finalizing preparations for a
commercial launch of AXS-05 for the treatment of MDD, if approved,
and continues with preparations for a launch of AXS-07 for the
acute treatment of migraine, if approved:
- Axsome’s
Digital Centric Commercialization™ (DCC) platform design and
technology implementation are complete. To ensure a smooth
execution at launch, testing of the integrated technology and tools
is on-going.
- With the
field leadership team on board, field force activities have been
focused on recruitment. At this time, the field force team build is
essentially complete with all signed offers contingent upon
approval. The Company anticipates having all field representatives
on board by launch.
- The
market access team continues to engage in permitted ongoing
discussion with payers, ensuring awareness of Axsome and of the
product profiles of both AXS-05 and AXS-07.
- All
marketing materials and patient support services for AXS-05 are
ready for execution in anticipation of a potential approval.
-
Commercial activities related to AXS-07 are on-going and
progressing accordingly.
Corporate
- In
October 2021, Axsome’s term loan facility agreement with Hercules
Capital, Inc. was amended. The amendment increased the size of the
facility to $300 million, increased the amount immediately
available upon FDA approval of AXS-05 for MDD to $100 million,
and provides access to an additional $150 million thereafter, at
the Company’s option. The amendment also extends the maturity and
interest-only period of the facility.
Anticipated Milestones
-
Regulatory and Commercial:
- AXS-05
for MDD, FDA action on NDA
- AXS-07
for migraine, FDA action on NDA (PDUFA date April 30, 2022)
- AXS-05
for MDD, commercial launch, if approved
- AXS-07
for acute migraine, commercial launch, if approved (2022)
- AXS-14
for fibromyalgia, NDA submission (2023)
-
Clinical Trial Readouts:
- Phase 3
SYMPHONY trial of AXS-12 in narcolepsy, topline data (1H 2023)
- Phase 3
ACCORD trial of AXS-05 for Alzheimer’s disease agitation, topline
data (1H 2023)
Upcoming Scientific
Conferences
Axsome is scheduled to present data at the
following upcoming scientific conference:
- American
College of Neuropsychopharmacology (ACNP) Annual Meeting, December
5-8, 2021
Third Quarter 2021 Financial Results
-
Research and development (R&D) expenses:
R&D expenses were $13.2 million for the three months ended
September 30, 2021 and $14.8 million for the comparable period in
2020. The decrease was driven by completion of clinical trials that
were ongoing in the prior comparable period.
-
General and administrative (G&A) expenses:
G&A expenses were $20.2 million for the three months ended
September 30, 2021 and $6.3 million for the comparable period in
2020. The increase was primarily related to pre-commercial
activities and personnel expense, along with an increase in
non-cash stock compensation expense.
- Net
loss: Net loss was $34.9 million, or $(0.93) per share,
for the three months ended September 30, 2021 compared to a net
loss of $22.9 million, or $(0.61) per share, for the comparable
period in 2020.
-
Cash: At September 30, 2021, Axsome had $114.6
million of cash compared to $183.9 million at December 31,
2020.
- Shares
outstanding: At September 30, 2021, Axsome had 37,687,883
shares of common stock outstanding.
Financial Guidance
- Axsome believes
that its cash at September 30, 2021, along with the remaining
committed capital from the $300 million term loan facility, is
sufficient to fund anticipated operations, based on the current
operating plan, which includes costs for the potential commercial
launch of AXS-05 in MDD and AXS-07 in migraine, into at least
2024.
- Axsome expects
that its operating expenses will increase year over year as it
continues to build out the commercial function and further
advance its pipeline.
Conference Call Information
Axsome will host a conference call and webcast
today at 8:00 AM Eastern to discuss third quarter 2021 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 6365926. 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 biopharmaceutical
company developing novel therapies for central nervous system (CNS)
conditions that have limited treatment options. Through development
of therapeutic options with novel mechanisms of action, we are
transforming the approach to treating CNS conditions. At Axsome, we
are committed to developing products that meaningfully improve the
lives of patients and provide new therapeutic options for
physicians. 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, whether potential filing issues or issues
identified by FDA during the substantive review may impact the
potential approvability of the Company’s NDA submission for AXS-05
in MDD or the timing of such approval, and whether the FDA will
agree with the Company’s discontinuation of the bupropion treatment
arm of the ADVANCE study in accordance with the independent data
monitoring committee’s recommendations); whether issues identified
by FDA during the substantive review may impact the potential
approvability of the Company’s NDA for AXS-07 for the acute
treatment of migraine in adults with or without aura, pursuant to
our special protocol assessment for the MOMENTUM clinical trial;
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 amount of capital required for the Company’s
commercial launch of its product candidates, and the potential
impact on the Company’s anticipated cash runway; unforeseen
circumstances or other disruptions to normal business operations
arising from or related to COVID-19; 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 |
|
|
Nine Months Ended |
|
|
September 30, |
|
|
September 30, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
13,180,258 |
|
|
$ |
14,795,493 |
|
|
$ |
44,279,272 |
|
|
$ |
52,859,850 |
|
General and administrative |
$ |
20,226,884 |
|
|
$ |
6,331,308 |
|
|
$ |
47,819,618 |
|
|
$ |
18,537,242 |
|
Total operating expenses |
|
33,407,142 |
|
|
|
21,126,801 |
|
|
|
92,098,890 |
|
|
|
71,397,092 |
|
Loss from operations |
|
(33,407,142 |
) |
|
|
(21,126,801 |
) |
|
|
(92,098,890 |
) |
|
|
(71,397,092 |
) |
Interest and amortization of debt
discount (expense) income |
|
(1,475,535 |
) |
|
|
(551,002 |
) |
|
|
(4,327,966 |
) |
|
|
(1,091,849 |
) |
Loss on extinguishment of
debt |
|
— |
|
|
|
(1,247,012 |
) |
|
|
— |
|
|
|
(1,247,012 |
) |
Net loss |
$ |
(34,882,677 |
) |
|
$ |
(22,924,815 |
) |
|
$ |
(96,426,856 |
) |
|
$ |
(73,735,953 |
) |
Net loss per common share, basic
and diluted |
$ |
(0.93 |
) |
|
$ |
(0.61 |
) |
|
$ |
(2.57 |
) |
|
$ |
(1.98 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
37,680,966 |
|
|
|
37,311,726 |
|
|
|
37,569,416 |
|
|
|
37,158,513 |
|
Balance Sheet Information:
|
September 30,2021 |
|
|
December 31,2020 |
|
Cash and cash equivalents |
$ |
114,622,893 |
|
|
$ |
183,876,453 |
|
Total assets |
|
116,598,522 |
|
|
|
186,134,323 |
|
Loan payable, current and
long-term |
|
49,173,709 |
|
|
|
48,321,848 |
|
Accumulated deficit |
|
(375,222,949 |
) |
|
|
(278,796,093 |
) |
Stockholders’ equity |
$ |
42,717,844 |
|
|
$ |
113,792,909 |
|
Axsome Contact: Mark
JacobsonChief Operating OfficerAxsome Therapeutics, Inc.22
Cortlandt Street, 16th FloorNew York, NY 10007Tel:
212-332-3243Email:
mjacobson@axsome.com www.axsome.com
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