Continued momentum expected in 2017 with
several programs anticipating clinical trial results this year,
including two Phase 3 programs
Phase 2 placebo-controlled study of SAGE-217 in
major depressive disorder expected to begin in 1H 2017
First NMDA candidate, SAGE-718, planned to
enter Phase 1 clinical testing in 1H 2017
Jim Doherty, Ph.D., promoted to Chief Research
Officer to lead Sage’s new Experimental Medicine group
Conference call today at 8:00 AM ET
Sage Therapeutics, Inc. (NASDAQ: SAGE) today reported
business highlights and financial results for the fourth quarter
and full year ended December 31, 2016.
“Sage is continuing its vision to “rethink” the development of
treatments for central nervous system disorders and, in doing so,
attempting to close the innovation gap in an area of disease that
represents approximately one-third of the worldwide burden of
illness. We are now at a point of significant momentum following
the pipeline transformation witnessed in 2016, resulting in at
least eight anticipated data readouts across multiple different
mood, movement and neurological disorders this year, including the
results we announced earlier this month. In addition, plans are
underway for our potential first commercial launch in 2018,” said
Jeff Jonas, M.D., Chief Executive Officer of Sage. “We believe that
a key element of our success to date has been our utilization of
novel and efficient approaches to translational science
facilitating the discovery and clinical development of our
differentiated investigational medicines. Our new Experimental
Medicine group, led by Jim Doherty, Ph.D., will further build on
this expertise by establishing a translational foundation across
our discovery and clinical programs that we believe will better
position Sage for long-term success.”
Recent Corporate
Highlights
- Jim Doherty, Ph.D., promoted to
Chief Research Officer: Dr. Doherty joined Sage in 2012 and
most recently served as Senior Vice President of Research. Before
Sage, he served as Director and Head of the Neuroscience Department
for the CNS and Pain Innovative Medicine Unit of AstraZeneca
Pharmaceuticals in Sodertalje, Sweden, and prior to that, he was
Director and Head of the Neuroscience Department at AstraZeneca
Pharmaceuticals in Wilmington, Delaware. He has experience with
discovery, translational science and early development in several
areas of neuroscience research, including psychiatry, neurology,
cognition, epilepsy and analgesia. He has authored more than 30
peer-reviewed research and review articles. Dr. Doherty holds a
B.A. in biology from the University of Delaware and a Ph.D. in
neuroscience from Georgetown University. He was a postdoctoral
fellow at Emory University Medical School.
- Experimental Medicine group to lead
translational neuroscience strategy: As part of his new role as
Chief Research Officer, Dr. Doherty will build and lead a new
Experimental Medicine capability within Sage. The Experimental
Medicine group will have four key goals:
- Identify functional biomarkers in
animals that respond to target engagement and can be deployed in
human clinical trials
- Identify genetic and biochemical
criteria to identify patient populations to increase the technical
probability of success of a clinical trial
- Translate insights between compounds
and indications for better odds of success across the pipeline
- Oversee small, exploratory human
studies in new disease areas
- Patent issued on SAGE-217: Sage
was recently granted a patent by the United States Patent and
Trademark Office, patent number 9,512,165, with claims covering the
composition of matter of SAGE-217.
- SAGE-547 receives United States
Adopted Name (USAN), brexanolone: Sage was recently informed
that the USAN Council adopted brexanolone (pronunciation: brek san’
oh lone) as the USAN (nonproprietary or generic name) for SAGE-547.
Brexanolone is also under review as an international nonproprietary
name (INN) by the World Health Organization (WHO).
Pipeline Update
Sage is advancing a portfolio of novel central nervous system
(CNS) product candidates targeting the GABA and NMDA receptor
systems. Dysfunction in these systems is known to be at the core of
numerous psychiatric and neurological disorders. Sage is pursuing a
data-driven approach to CNS drug development by employing efficient
human proof-of-concept studies to uncover both activity signals and
to help understand future trial methodology, before investing in
larger clinical programs.
- Brexanolone (SAGE-547): Sage is
currently developing brexanolone in separate Phase 3 clinical
programs as an acute interventional treatment for super-refractory
status epilepticus (SRSE) and postpartum depression (PPD).
Brexanolone is Sage’s proprietary IV formulation of
allopregnanolone, a naturally occurring neuroactive steroid that
acts as a synaptic and extrasynaptic modulator of the GABAA
receptor.
- SRSE: Sage is evaluating
brexanolone (SAGE-547) in the Phase 3 STATUS Trial, a global,
randomized, double-blind, placebo-controlled trial, designed to
evaluate brexanolone as a potential adjunctive therapy for SRSE, a
rare and life-altering seizure condition. The Phase 3 clinical
program is being conducted in agreement with the U.S. Food and Drug
Administration (FDA) under a Special Protocol Assessment (SPA).
Sage also received positive scientific advice in the fourth quarter
of 2016 from the European Medicines Agency (EMA). Based on this
advice, the Company believes the Phase 3 clinical program, if
successful, will be sufficient to support a marketing authorization
application (MAA) to the EMA seeking approval of brexanolone for
SRSE in the EU.
- PPD: Sage is currently
enrolling its Phase 3 clinical program evaluating brexanolone
(SAGE-547) as a potential treatment for PPD, consisting of separate
placebo-controlled trials in severe PPD patients (202B) and in
moderate PPD patients (202C), collectively known as the Hummingbird
Study. In 2016, the FDA granted Breakthrough Therapy Designation
and the EMA granted PRIority MEdicines (PRIME) designation to
brexanolone for the treatment of PPD.
- SAGE-217: Sage’s most
advanced, next-generation product candidate is SAGE-217, a novel,
orally-active neuroactive steroid that, like brexanolone
(SAGE-547), is a positive allosteric modulator of GABAA receptors,
targeting both synaptic and extrasynaptic GABAA receptors. In the
fourth quarter of 2016, Sage initiated Phase 2 development for
SAGE-217 in both mood and movement disorders, with four Phase 2
clinical programs now underway.
- Mood Disorders:
- Major Depressive Disorder
(MDD): Earlier this month, Sage reported positive clinical
results from Part A of a two-part Phase 2 clinical trial evaluating
the safety, tolerability, pharmacokinetics and efficacy of SAGE-217
in patients with moderate to severe MDD. Part A of the Phase 2
trial was an open-label study evaluating SAGE-217 in 13 patients.
The primary endpoint for the Part A study was to evaluate the
safety and tolerability of SAGE-217. The secondary endpoint was to
evaluate the effect of SAGE-217 compared to baseline following two
weeks of once-nightly treatment as measured by the HAM-D total
score. The Part B phase, a randomized, double-blind,
parallel-group, placebo-controlled study evaluating SAGE-217 as a
treatment for MDD, is expected to be initiated in the first half of
2017.
- PPD: Sage is currently
enrolling its Phase 2 clinical trial of SAGE-217 in PPD based on
positive results to date from the brexanolone (SAGE-547) PPD
clinical program. The Phase 2a multi-center, double-blind,
placebo-controlled, randomized trial will evaluate the efficacy,
safety, tolerability, and pharmacokinetics of SAGE-217 in the
treatment of patients with severe PPD. Top-line results from the
PPD study are expected in the second half of 2017.
- Movement Disorders:
- Essential tremor: Sage is
currently enrolling its Phase 2 clinical trial of SAGE-217 in
essential tremor. The efficacy, safety, tolerability, and
pharmacokinetics of SAGE-217 are being evaluated in the Phase 2a
multi-center, double-blind, placebo-controlled, randomized
withdrawal trial in the treatment of patients with essential
tremor. Top-line results from the essential tremor study are
expected in the second half of 2017.
- Parkinson's disease: Sage
is currently enrolling Part A of a two-part Phase 2 clinical trial
of SAGE-217 in Parkinson's disease. Part A of the Phase 2 trial is
an open-label, proof-of-concept study which, if positive, may lead
to a randomized, placebo-controlled Part B of the Phase 2 trial.
Top-line results from the Part A study are expected in the first
half of 2017.
- Other GABA Programs: Sage is
currently evaluating a series of novel GABA modulators in
pre-clinical development, including SAGE-105, SAGE-324 and
SAGE-689. Sage recently initiated IND-enabling studies of SAGE-105
and SAGE-324, which are novel, orally-active next-generation GABA
modulators that are intended to be developed for GABA-related
indications, such as orphan epilepsies and other disorders
involving GABA hypofunction.
- NMDA: Sage is also developing
novel compounds that target the NMDA receptor. The first product
candidate selected for development from this program is SAGE-718,
an oxysterol-based NMDA positive allosteric modulator. Our initial
focus for development of SAGE-718 is on cerebrosterol deficit
disorders, anti-NMDA receptor encephalitis, and other indications
involving NMDA hypofunction. SAGE-718 has completed IND-enabling
studies and Sage expects to initiate Phase 1 clinical development
for SAGE-718 in the first half of 2017.
Expected Near-Term Clinical
Milestones
- Trial Initiations:
- Part B of Phase 2 trial of SAGE-217 in
MDD (1H 2017)
- Phase 1 program of first NMDA
candidate, SAGE-718 (1H 2017)
- Top-Line Data Readouts:
- Phase 3 STATUS Trial of brexanolone
(SAGE-547) in SRSE (1H 2017)
- Part A open-label portion of Phase 2
trial of SAGE-217 in Parkinson's disease (1H 2017)
- Phase 3 trial (202B) of brexanolone
(SAGE-547) in PPD (2H 2017)
- Phase 3 trial (202C) of brexanolone
(SAGE-547) in PPD (2H 2017)
- Phase 2 trial of SAGE-217 in essential
tremor (2H 2017)
- Phase 2 trial of SAGE-217 in PPD (2H
2017)
- Phase 1 single-ascending dose (SAD)
trial of SAGE-718 (2H 2017)
Financial Results for the Fourth
Quarter and Full Year 2016
- Cash Position: Cash, cash
equivalents and marketable securities as of December 31, 2016 were
$397.5 million, compared with $186.8 million at December 31,
2015.
- R&D Expenses: Research
and development expenses were $42.0 million, including $5.0 million
of non-cash stock-based compensation expense, in the fourth quarter
of 2016, compared to $20.4 million, including $1.6 million of
non-cash stock-based compensation expense, for the same period of
2015. For the year ended December 31, 2016, research and
development expenses were $120.8 million, including $11.2 million
of non-cash stock-based compensation expense, compared to $69.4
million, including $5.9 million of non-cash stock-based
compensation expense, for the same period of 2015. The increase in
R&D expenses year-over-year was primarily due to the ongoing
clinical development of brexanolone (SAGE-547) in SRSE and PPD;
completion of Phase 1 development for SAGE-217; initiation of the
Phase 2 clinical programs for SAGE-217; the ongoing IND-enabling
studies for SAGE-718; and investments in R&D headcount to
support the growth in Sage’s pipeline and operations.
- G&A Expenses: General
and administrative expenses were $14.4 million, including $5.1
million of non-cash stock-based compensation expense, in the fourth
quarter of 2016, compared to $8.2 million, including $2.5 million
of non-cash stock-based compensation expense, for the same period
of 2015. For the year ended December 31, 2016, general and
administrative expenses were $39.4 million, including $11.8 million
of non-cash stock-based compensation expense, compared to $25.3
million, including $9.3 million of non-cash stock-based
compensation expense, for the same period of 2015. The increase in
G&A expenses year-over-year was primarily due to the increase
in personnel-related expenses, professional fees and
facilities-related costs to support expanding operations, as well
as continued preparations for a potential commercial launch.
- Net Loss: Net loss was
$55.9 million for the fourth quarter of 2016 and $159.0 million for
the year ended December 31, 2016, compared to a net loss of $28.6
million and $94.5 million, respectively, for the comparable periods
of 2015.
- Financial Guidance: Sage expects
that its existing cash, cash equivalents and marketable securities
will fund its anticipated level of operations, based on its current
operating plans, into the second quarter of 2018.
Conference Call
InformationSage will host a conference call and webcast
today at 8:00 AM ET to discuss its fourth quarter and
year-end 2016 financial results and recent corporate updates. The
live webcast can be accessed on the investor page of Sage's website
at investor.sagerx.com. The conference call can be accessed by
dialing 1-866-450-8683 (toll-free domestic) or 1-281-542-4847
(international) and using the conference ID 69937798. A replay of
the webcast will be available on Sage’s website approximately two
hours after the completion of the event and will be archived for up
to 30 days.
About Sage TherapeuticsSage
Therapeutics is a clinical-stage biopharmaceutical company
committed to developing novel medicines to transform the lives of
patients with life-altering central nervous system (CNS) disorders.
Sage has a portfolio of novel product candidates targeting critical
CNS receptor systems, GABA and NMDA. Sage's lead program,
brexanolone (SAGE-547), is in Phase 3 clinical development for
super-refractory status epilepticus, a rare and severe seizure
disorder, and for postpartum depression. Sage is developing its
next generation modulators, including SAGE-217 and SAGE-718, with a
focus on acute and chronic CNS disorders. For more information,
please visit www.sagerx.com.
Forward-Looking
StatementsVarious statements in this release concern
Sage's future expectations, plans and prospects, including without
limitation: our expectations for 2017; our expectations regarding
development of our product candidates and their potential in the
treatment of various CNS disorders; the expected timing of
initiation and completion of clinical trials; the anticipated
availability and announcement of data and results from clinical
trials of our product candidates; our goals and expectations with
respect to our discovery and translational science efforts; our
plans for evaluation of new indications and new compounds; our
expectations regarding the regulatory pathway for brexanolone
(SAGE-547) in the treatment of SRSE in the EU, and our belief that
the results of the current development program for brexanolone in
SRSE, if successful, will be sufficient for an MAA filing in the
EU; our expectations regarding a potential future NDA filing and
commercial launch of brexanolone, if successfully developed and
approved; and our expectations with respect to future cash use and
cash needs. These forward-looking statements are neither
promises nor guarantees of future performance, and are subject to a
variety of risks and uncertainties, many of which are beyond our
control, which could cause actual results to differ materially from
those contemplated in these forward-looking statements, including
the risks that: we may continue to experience slower than expected
enrollment and randomization of evaluable patients in the STATUS
trial or slower than expected clinical site initiation and
enrollment in our other clinical trials, or the potential need for
additional analysis or data or the need to enroll additional
patients, leading to possible delays in completion of trials or in
the availability of data; we may not be able to generate supportive
non-clinical data or to successfully demonstrate the efficacy and
safety of our product candidates at each stage of clinical
development; success in our non-clinical studies or in earlier
stage clinical trials may not be repeated or observed in ongoing or
future studies involving the same compound or other product
candidates, and ongoing and future pre-clinical and clinical
results may not support further development of product candidates
or be sufficient to gain regulatory approval to launch and
commercialize any product; decisions or actions of regulatory
agencies may affect the initiation, timing, progress and cost of
clinical trials, and our ability to proceed with further clinical
studies of a product candidate or to obtain marketing approval,
including the risk that the EMA may, despite scientific advice,
decide that the data from our Phase 3 trial in SRSE are not
sufficient to support approval; the internal and external costs
required for our activities, and to build our organization in
connection with such activities, and the resulting use of cash, may
be higher than expected, or we may conduct additional clinical
trials or pre-clinical studies or engage in new activities,
requiring additional expenditures and using cash more quickly than
anticipated; and we may encounter technical and other
unexpected hurdles in the development and manufacture of our
products which may delay our timing or increase our expenses and
use of cash, as well as those risks more fully discussed in the
section entitled "Risk Factors" in our most recent Quarterly Report
on Form 10-Q, as well as discussions of potential risks,
uncertainties, and other important factors in our subsequent
filings with the Securities and Exchange Commission. In
addition, any forward-looking statements represent our views only
as of today, and should not be relied upon as representing our
views as of any subsequent date. We explicitly disclaim any
obligation to update any forward-looking statements.
Sage Therapeutics, Inc. and
Subsidiaries Condensed Consolidated Balance Sheets (in
thousands) (unaudited)
December 31, 2016 December
31, 2015 Assets Current Assets: Cash and cash
equivalents $ 168,517 $ 186,753 Marketable securities 228,962 -
Prepaid expenses and other current assets 5,100 1,738
Total current assets 402,579 188,491 Property and equipment and
other long-term assets 1,952 525 Total assets $
404,531 $ 189,016
Liabilities and Stockholders'
Equity Current Liabilities: Accounts payable $ 12,817 $ 5,159
Accrued expenses 22,352 10,148 Total current
liabilities 35,169 15,307 Other liabilities 845 14
Total liabilities 36,014 15,321 Total stockholders' equity
368,517 173,695 Total liabilities and stockholders' equity $
404,531 $ 189,016
Sage Therapeutics, Inc. and
Subsidiaries Condensed Consolidated Statements of
Operations (in thousands, except share and per share data)
(unaudited)
Three Months Ended December 31, Year Ended December
31, 2016 2015 2016 2015 Operating
expenses: Research and development $ 42,004 $ 20,376 $ 120,756 $
69,357 General and administrative 14,375 8,236
39,407 25,293 Total operating
expenses 56,379 28,612 160,163
94,650 Loss from operations (56,379 )
(28,612 ) (160,163 ) (94,650 ) Interest income, net 494 63 1,211
178 Other expense, net (16 ) (13 ) (35 )
(23 ) Net loss $ (55,901 ) $ (28,562 ) $ (158,987 ) $
(94,495 ) Net loss per share - basic and diluted $ (1.50 ) $ (0.99
) $ (4.75 ) $ (3.40 ) Weighted average shares outstanding - basic
and diluted 37,198,631 28,810,565
33,492,795 27,778,288
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170223005412/en/
Investor Contact:Sage TherapeuticsPaul Cox,
617-299-8377paul.cox@sagerx.comorMedia Contact:Suda
Communications LLCMaureen L. Suda,
585-387-9248maureen.suda@sagerx.com
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