WOODBRIDGE, ON, May 29, 2013 /PRNewswire/ - Pivotal
Therapeutics Inc. (OTCQX: PVTTF) (CNSX: PVO), a specialty
pharmaceutical company with a focus on Omega-3 therapies
for cardiovascular disease (CVD) and overall health, announced
its
financial results and operational highlights for the three months
ended
March 31, 2013. All dollar
amounts referenced herein are in Canadian
dollars unless otherwise stated.
For the three months ended March 31,
2013 the Company reported a loss of
$783,436, or $0.01 per common share, compared with a loss of
$831,090
or $0.01 per common share for the
three months ended March 31,
2012.
At March 31, 2013, Pivotal's working
capital totaled $493,895 compared
with $452,914 at December 31, 2012.
"Our pilot marketing program for VASCAZEN continues to gain
traction,
with initial sales up more than 200% from the previous quarter.
Furthermore, the pilot program continues to provide valuable
information which we are incorporating into our plans for our
full
launch of VASCAZEN in 2013," said Mr. Eugene Bortoluzzi Chief Executive
Officer and Chief Financial Officer. "After presenting our
positive
results from our recently concluded
VASCAZEN®-REVEAL clinical trial, healthcare
professionals are realizing the benefits of
Vascazen® and how treating an Omega-3 deficiency
can address risk factors for
cardiovascular patients."
The audited consolidated financial statements, accompanying notes
to the
audited thereto and Management's Discussion and Analysis for the
three
months ended March 31, 2013, will be
accessible on SEDAR www.sedar.com, CNSX www.cnsx.ca under the
symbol "PVO" and OTCQX www.otcqx.com under the symbol
"PVTTF".
Pivotal highlights since December 31,
2012
March 6, 2013 - Pivotal exhibited at
the American College of
Cardiology's 62nd Annual Scientific Session and
Expo;
April 9, 2013 -
Vascazen® -Top line results accepted for
presentation at the American Heart
Association's ATVB 2013 Scientific Sessions;
April 30, 2013 - Pivotal announced
presentation entitled "Treatment of
Omega-3 Nutritional Deficiency Improves Cardiovascular Disease
Risk
Factors: Results of the Randomized, Double-Blind,
Placebo-Controlled VASCAZEN®- REVEAL Trial" at
the American Heart Association's ATVB 2013 Scientific
Sessions;
May 2, 2013 - Pivotal's founder,
Chairman and Chief Scientific Officers
Dr. Jackowski honoured with Queen
Elizabeth's Diamond Jubilee
Medal for
his contribution to Canadian biotech and the significant
improvement in
the quality of life and care for cardiac patients with the
development
of the rapid format cardiac blood test;
May 7, 2013 -
VASCAZEN®- REVEAL trial meets primary and
secondary endpoints, in eight weeks of treatment
with VASCAZEN® patients corrected an Omega-3
deficiency with positive concomitant
effects on their lipid profiles, mainly a 48% reduction of
triglycerides and a raise of HDL without negative impact on the
LDL-C
lipid profile.
Pivotal?s Goals for 2013:
Advance commercialization of Vascazen® with full
launch in the U.S.;
Expansion of the sales & marketing team;
Initiation of new clinical trials;
Completion of existing clinical trials for
Vascazen® and publication of scientific
data;
Expansion of intellectual property portfolio;
Investigation of international licensing opportunities;
Expansion of product offerings;
Investment community presentations to increase awareness;
Presentations and attendance at scientific meetings.
Notice of Annual General Meeting
Pivotal Therapeutics Inc. will hold its Annual General Meeting
of
Shareholders at 10:00 AM on
June 26, 2013 at the registered
office of
the Company, 81 Zenway Blvd., Unit 10, Woodbridge, Ontario.
About VASCAZEN
VASCAZEN® is currently available in the U.S. as a
prescription only Medical Food
specifically formulated for the dietary management of an
Omega-3
deficiency in cardiovascular patients. VASCAZEN®
is a >90% pure Omega-3 with a proprietary 6:1 EPA:DHA fatty
acid
formulation, protected by a series of both U.S. and foreign
patents. VASCAZEN® is the second to market
prescription only Omega-3 in the U.S. and is
available by prescription nationwide.
VASCAZEN® has been clinically shown to correct an
Omega-3 deficiency within 8
weeks of treatment with positive concomitant effects on the
lipid
profiles, mainly a 48% reduction of triglycerides and a raise of
HDL
without negative impact on the LDL-C lipid profile.
VASCAZEN®'s results were achieved with a dose of
3 grams of EPA and DHA per day
of a prescription grade, high purity Omega-3.
About Pivotal Therapeutics Inc.
Pivotal Therapeutics is a publicly traded (OTCQX: PVTTF) (CNSX:
PVO)
specialty pharmaceutical company with a focus on cardiovascular
disease
and overall health. Pivotal Therapeutics' lead product
VASCAZEN® is a prescription only Medical Food
formulated to meet the dietary
Omega-3 deficient needs of patients with cardiovascular disease
through
elevating Eicosapentaenoic acid (EPA) and Docosahexaenoic acid
(DHA) to
levels associated with reduced risk of cardiovascular
complications. OMAZENTM is a prescription grade
Omega-3 providing >90% total Omega-3 in each
capsule with a unique 6:1 ratio of EPA:DHA.
OMAZENTM is a patented product available for sale
and distribution in Canada.
Disclosure Notice
The information contained in this document is as of May 29, 2013. This
press release contains forward-looking statements. Such
forward-looking
statements are subject to a number of risks, assumptions and
uncertainties that could cause Pivotal's actual results to
differ
materially from those projected in such forward-looking
statements.
These statements can be identified by the use of words such as
"will",
"anticipate", "estimate", "expect", "project", "forecast",
"intend",
"plan", "believe", "project", "potential", and similar expressions
with
any discussion of future operating or financial performance or
events.
In particular, factors that could cause actual results to
differ
materially from those in forward looking statements include the
following: Pivotal's inability to obtain additional financing
on
acceptable terms; growth in costs and expenses; inability to
compete
with others who provide comparable products; risk that the
Company's
products will not gain widespread market acceptance; risks relating
to
the Company's ability to maintain its CSNX listing.
Forward-looking
statements speak only as of the date made and are not guarantees
of
future performance. The Company undertakes no obligation to
publicly
update or revise any forward-looking statements contained in
this
document as a result of new information or future events or
developments. CNSX has not reviewed and does not accept
responsibility
for the adequacy or accuracy of this information.
SOURCE Pivotal Therapeutics Inc.