SAN DIEGO, Aug. 11, 2014 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX) today provided a corporate
update and reported financial results for the quarter ended
June 30, 2014.
Brian M. Culley, Chief Executive
Officer, said: "This is an important time for Mast. We have
an ongoing Phase 3 study in a rare disease with more than an
18-month head start on our nearest competitor. We have an
ongoing Phase 2 study that will demonstrate whether MST-188
improves the effectiveness of a thrombolytic agent that's used
everywhere from acute limb ischemia to pulmonary embolism to heart
attack and stroke. We have another Phase 2 study planned in
heart failure, the leading cause of hospitalization in patients
over 65. And, we have cash to move these and our other
programs towards major value inflection points."
Upcoming News and Events
- Phase 2 Study (pulmonary arterial hypertension): preliminary
data
|
Q3 2014
|
- Phase 2 Study (heart failure): agreement with FDA on
protocol
|
Q4 2014
|
- Nonclinical Study (heart failure):
data
|
Q1 2015
|
- Nonclinical Study (embolic stroke): data
|
Q2 2015
|
- Phase 2 Study (heart failure): initiate
enrollment
|
1H 2015
|
- Phase 2 Study (acute limb ischemia): complete
enrollment
|
Q4 2015
|
- EPIC Study (sickle cell disease): complete
enrollment
|
Q4 2015
|
- Phase 2 Study (WHO Group 2 pulmonary hypertension):
data
|
2H 2015
|
- Phase 2 Study (heart failure): data (interim
analysis)
|
2H 2015
|
More information regarding these events and each of the
Company's programs is provided in the "Corporate Update" section,
below.
Corporate Update
MST-188 – Sickle Cell Disease (SCD)
The Company
continues to enroll patients in EPIC, its pivotal Phase 3 study of
MST-188 in SCD, and reiterates its prior guidance that enrollment
will complete at the end of 2015. MST-188 has orphan drug
status for SCD in both the U.S. and EU, as well as fast track
status with the FDA.
The Company recently announced or completed several of numerous
initiatives underway to support MST-188, the most clinically
advanced new drug in development to treat an on-going crisis in
SCD, including:
- Announced data from an ex vivo study, conducted at
Loyola University Medical Center, where
MST-188 reduced mean erythrocyte sedimentation rate, a measure of
inflammation, by 50% relative to control in blood collected from
individuals with sickle cell disease, which adds to the body of
data supporting MST-188's potential to shorten the duration of
sickle cell crisis;
- Initiated patient enrollment in a sub-study within EPIC to
quantify the effect of MST-188 on tissue oxygenation, which will
provide insight into the potential for MST-188 to reduce end-organ
failure and associated premature death in individuals with sickle
cell disease; and
- Reported that, following a review of clinical data from
enrolled subjects, the EPIC independent data safety monitoring
board recommended the EPIC study continue without
modification.
MST-188 – Occlusive Arterial Disease
In 2014, the
Company achieved several milestones related to its clinical-stage
program in occlusive arterial disease, including:
- Initiated a Phase 2 study that will demonstrate whether MST-188
improves the effectiveness of recombinant tissue plasminogen
activator (rt-PA) in patients with acute limb ischemia, a
complication of occlusive arterial disease;
- Initiated a nonclinical study in a well-validated model of
embolic stroke that will demonstrate whether and to what degree
MST-188 extends the therapeutic window of rt-PA, the potential for
which is based on studies showing that MST-188 salvages tissue in
the "ischemic penumbra," protects the blood-brain barrier, improves
thrombolysis, and improves blood-flow in collateral (non-occluded)
vessels; and
- Obtained from the FDA orphan drug designation for MST-188 for
the treatment of acute limb ischemia (Nov
2013) and submitted an application for orphan drug
designation in the EU.
An estimated 800,000 people suffer a stroke each year in the
U.S. (15 million worldwide), over 85% of which are ischemic
strokes, yet the American Heart Association estimates that only 7%
of all hospital admissions for acute ischemic stroke receive rt-PA,
the only FDA-approved drug. A major reason for the limited
use of rt-PA is its narrow therapeutic window (within 3 hours of
onset of stroke symptoms), as well as the risk of intracerebral
hemorrhage. An agent that improves the effectiveness of rt-PA
(which the Company is evaluating in its ongoing Phase 2 study)
and/or expands its therapeutic window (which the Company is
evaluating in its ongoing nonclinical study) has the potential to
improve outcomes and make rt-PA an option in the estimated 93% of
hospital admissions where it is not used.
MST-188 – Heart Failure
Earlier this year, the
Company reported positive results from a nonclinical study in a
well-validated model of chronic heart failure, in which a single,
2-hour infusion of MST-188 demonstrated statistically significant,
progressive and lasting (up to 2 weeks) improvements in key
hemodynamic parameters and markers of cardiac injury and
stress. Based on feedback from cardiovascular thought
leaders, the Company plans to develop MST-188 in heart
failure. Near-term activities include:
- Initiating additional nonclinical study(ies) to evaluate how
long (beyond 2 weeks) previously observed improvements persist and
the effect of repeat administration of MST-188, as well as to
characterize the mechanism underlying observed improvements;
- Reaching agreement with FDA on requirements to initiate a Phase
2 study of MST-188 in patients with heart failure; and
- Initiating the Phase 2 study in heart failure, which may
demonstrate that MST-188 reduces biomarkers associated with
increased 180-day all-cause mortality in heart failure
patients.
Over 25% of Medicare patients discharged following
hospitalization for heart failure will be re-admitted within 30
days. This high rate may reflect the limitations of existing
treatment options (e.g., vaso-dilators, diuretics), which are
effective at resolving the symptoms of heart failure (e.g., edema)
but may not directly improve heart function. In contrast, the
Company believes the membrane-sealing activity of MST-188 directly
improve heart contractility and function. Further, the
Company's ongoing nonclinical study will determine whether a second
dose of MST-188 duplicates the benefits observed after the first
dose and extends improvements to 4 weeks (or beyond), which may
translate into a positive impact on rehospitalization rates, such
as 30-day readmission.
MST-188 – Trauma
Recently, the Company signed a
Cooperative Research and Development Agreement with a branch of the
U.S. military to evaluate the utility of MST-188 in specific models
of trauma of interest to the U.S. government. Pilot studies
are expected to begin in 2014. If results are positive, the
Company expects the U.S. government will be interested in further
exploring the potential of MST-188 as a treatment following major
trauma.
AIR001 – Pulmonary Hypertension
In February 2014, the Company completed its
acquisition of Aires Pharmaceuticals, a clinical-stage
biopharmaceutical company, and its lead product candidate,
AIR001. Near-term news and events related to AIR001
include:
- Reporting data from the 29 patients enrolled in a Phase 2 study
in pulmonary arterial hypertension;
- Initiating enrollment of patients with pulmonary hypertension
with left heart disease (WHO Group 2 PH) in an on-going
university-sponsored Phase 2 study of AIR001; and
- Announcing the Company's overall development strategy with
AIR001.
Board of Directors
In June, the Company expanded its
expertise and depth by welcoming Dr. Howard
Dittrich to its Board of Directors. Dr. Dittrich
brings a proven track record of success in cardiovascular disease,
evidenced in part by the sale of NovaCardia to Merck & Co. in
2007 for $350
million.
Second Quarter 2014 Financial Results
The Company's net loss for the second quarter of 2014 was
$7.2 million, or $0.06 per share (basic and diluted), compared to
a net loss of $4.9 million, or
$0.09 per share (basic and diluted),
for the same period in 2013.
Research and development expenses for the second quarter of 2014
were $4.8 million, an increase of
$2.0 million, or 70%, compared to
$2.8 million for the same period in
2013. The increase was primarily due to a $1.1 million increase in external clinical study
fees and expenses, a $0.6 million
increase in external nonclinical study fees and expenses and a
$0.3 million increase in personnel
costs. The increase in external clinical study fees and
expenses was largely related to the Company's ongoing pivotal Phase
3 study in sickle cell disease (the EPIC study) and Phase 2 study
in ALI. The increase in external nonclinical study fees and
expenses was primarily related to manufacturing additional MST-188
clinical trial material.
Selling, general and administrative expenses for the second
quarter of 2014 were $2.4 million, an
increase of $0.3 million, or 13%,
compared to $2.1 million for the same
period in 2013. The increase resulted primarily from an increase in
personnel costs.
Year-to-Date Financial Results
The Company's net loss for the six months ended June 30, 2014 was $13.5
million, or $0.12 per share
(basic and diluted), compared to a net loss of $10.5 million, or $0.21 per share (basic and diluted), for the same
period in 2013.
Research and development expenses for the six months ended
June 30, 2014 were $9.1 million, an increase of $2.8 million, or 45%, compared to $6.3 million for the same period in 2013. The
increase was primarily due to a $1.1
million increase in external clinical study fees and
expenses, a $1.1 million increase in
external nonclinical study fees and expenses and a $0.6 million increase in personnel costs.
The increase in external clinical study fees and expenses was
related primarily to the ongoing EPIC study and Phase 2 study in
ALI, as well as the wind-down of the AIR001 studies in PAH, which
increased costs were offset by the absence of any material fees and
expenses related to its thorough QT/QTc clinical study of MST-188
that was completed in 2013. The increase in external
nonclinical study fees and expenses was primarily related to
manufacturing additional MST-188 clinical trial material. The
increase in personnel costs was primarily related to additional
clinical and research-related manufacturing staff hired after the
first half of 2013.
Selling, general and administrative expenses for the six months
ended June 30, 2014 were $4.6 million, an increase of $0.4 million, or 10%, compared to $4.2 million for the same period in 2013. The
increase resulted primarily from an increase in personnel
costs.
The Company recognized a $0.5
million bargain purchase gain during the six months ended
June 30, 2014 associated with its
acquisition of Aires, which was included in other income.
Balance Sheet Highlights
As of June 30, 2014, the Company
had cash, cash equivalents and investment securities totaling
$46.4 million. Stockholders' equity
amounted to $50.2 million as of
June 30, 2014.
About Mast Therapeutics
Mast Therapeutics, Inc. is a publicly traded biopharmaceutical
company headquartered in San
Diego, California. The Company is leveraging the MAST
(Molecular Adhesion and Sealant Technology) platform, derived from
over two decades of clinical, nonclinical and manufacturing
experience with purified and non-purified poloxamers, to develop
MST-188, its lead product candidate, for serious or
life-threatening diseases and conditions typically characterized by
impaired microvascular blood flow and damaged cell
membranes.
The Company is enrolling subjects in EPIC, a pivotal Phase 3
study of MST-188 in sickle cell disease, and in a Phase 2 study to
evaluate whether MST-188 improves the effectiveness of recombinant
tissue plasminogen activator therapy in patients with acute limb
ischemia. The Company also is planning to initiate a Phase 2
clinical study of MST-188 in patients with acute decompensated
heart failure in the first half of 2015 and to announce details of
the study's design later this year. More information can be
found on the Company's web site at www.masttherapeutics.com.
(Twitter: @MastThera)
Mast Therapeutics™ and the corporate logo are trademarks of Mast
Therapeutics, Inc.
Forward Looking Statements
Mast Therapeutics cautions you that statements included in this
press release that are not a description of historical facts are
forward-looking statements that are based on the Company's current
expectations and assumptions. Such forward-looking statements
include, but are not limited to, statements relating to prospects
for successful development of MST-188 in sickle cell disease,
occlusive arterial disease, including ALI, heart failure, and
trauma, and the anticipated timing of achievement of development
milestones for its product candidates, including commencement and
completion of clinical and nonclinical studies. Among the factors
that could cause or contribute to material differences between the
Company's actual results and the expectations indicated by the
forward-looking statements are risks and uncertainties that
include, but are not limited to: the uncertainty of outcomes in
ongoing and future studies of the Company's product candidates and
the risk that its product candidates, including MST-188, may not
demonstrate adequate safety, efficacy or tolerability in one or
more such studies, including EPIC; delays in the commencement or
completion of clinical studies, including as a result of
difficulties in obtaining regulatory agency agreement on clinical
development plans or clinical study design, opening trial sites,
enrolling study subjects, manufacturing sufficient quantities of
clinical trial material, being subject to a "clinical hold," and/or
suspension or termination of a clinical study, including due to
patient safety concerns or lack of funding; the potential for
institutional review boards or the FDA or other regulatory agencies
to require additional nonclinical or clinical studies prior to
initiation of a planned clinical study of a product candidate; the
risk that, even if clinical studies are successful, the FDA or
other regulatory agencies may determine they are not sufficient to
support a new drug application; the potential that, even if
clinical studies of a product candidate in one indication are
successful, clinical studies in another indication may not be
successful; the Company's reliance on contract research
organizations (CROs), contract manufacturing organizations (CMOs),
and other third parties to assist in the conduct of important
aspects of development of its product candidates, including
clinical studies, manufacturing, and regulatory activities for its
product candidates, and that such third parties may fail to perform
as expected; the Company's ability to obtain additional funding on
a timely basis or on acceptable terms, or at all; the potential for
the Company to delay, reduce or discontinue current and/or planned
development activities, including clinical studies, partner its
product candidates at inopportune times or pursue less expensive
but higher-risk and/or lower return development paths if it is
unable to raise sufficient additional capital as needed; the risk
that, even if the Company successfully develops a product candidate
in one or more indications, it may not realize commercial success
with its products and may never generate revenue sufficient to
achieve profitability; the risk that the Company is not able to
adequately protect its intellectual property rights relating to the
MAST platform and MST-188 or AIR001 and prevent competitors from
duplicating or developing equivalent versions of its product
candidates; and other risks and uncertainties more fully described
in the Company's press releases and periodic filings with the
Securities and Exchange Commission. The Company's public filings
with the Securities and Exchange Commission are available at
www.sec.gov.
You are cautioned not to place undue reliance on forward-looking
statements, which speak only as of the date when made. Mast
Therapeutics does not intend to revise or update any
forward-looking statement set forth in this press release to
reflect events or circumstances arising after the date hereof,
except as may be required by law.
[Tables to Follow]
Mast Therapeutics,
Inc.
|
Condensed
Consolidated Statements of Operations
|
(In thousands except
per share data)
|
|
|
|
|
|
|
|
Three months
ended June
30, (Unaudited)
|
|
Six months
ended June
30, (Unaudited)
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
|
Total net
revenue
|
$
—
|
|
$
—
|
|
$
—
|
|
$
—
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
4,820
|
|
2,837
|
|
9,101
|
|
6,280
|
Selling, general and
administrative
|
2,370
|
|
2,100
|
|
4,636
|
|
4,213
|
Transaction-related
expenses
|
(11)
|
|
7
|
|
269
|
|
35
|
Depreciation and
amortization
|
23
|
|
9
|
|
35
|
|
18
|
Total operating
expenses
|
7,202
|
|
4,953
|
|
14,041
|
|
10,546
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(7,202)
|
|
(4,953)
|
|
(14,041)
|
|
(10,546)
|
|
|
|
|
|
|
|
|
Interest and other
income, net
|
50
|
|
12
|
|
518
|
|
24
|
|
|
|
|
|
|
|
|
Net loss
|
$ (7,152)
|
|
$ (4,941)
|
|
$ (13,523)
|
|
$ (10,522)
|
|
|
|
|
|
|
|
|
Net loss per share –
basic and diluted
|
$ (0.06)
|
|
$ (0.09)
|
|
$
(0.12)
|
|
$
(0.21)
|
|
|
|
|
|
|
|
|
Weighted average
shares – basic and diluted
|
115,587
|
|
53,750
|
|
110,350
|
|
50,028
|
Mast Therapeutics,
Inc.
|
Balance Sheet
Data
|
(In
thousands)
|
|
|
June 30,
2014
(Unaudited)
|
|
December
31,
2013
|
|
|
|
|
Cash, cash
equivalents and investment securities
|
$
46,438
|
|
$
44,393
|
|
|
|
|
Working
capital
|
41,819
|
|
40,695
|
|
|
|
|
Total
assets
|
59,370
|
|
55,250
|
|
|
|
|
Total
liabilities
|
9,149
|
|
7,442
|
|
|
|
|
Stockholders'
equity
|
50,221
|
|
47,808
|
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SOURCE Mast Therapeutics, Inc.