WOODBRIDGE, ON, Nov. 28, 2014 /PRNewswire/ - Pivotal
Therapeutics Inc. (OTCQX:PVTTF; CSE:PVO), ("Pivotal" or the
"Company"), a specialty pharmaceutical company with a focus on
Omega-3 therapies for cardiovascular disease (CVD) and overall
health, announced its accomplishments and financial results for the
three months ended September 30,
2014. All dollar amounts referenced herein are in Canadian
dollars unless otherwise stated.
During the third quarter the Company expanded its product line
to address new market segments that include the over-the-counter
(OTC) marketplace. Pivotal created Benefishial™
specifically to be sold in the OTC direct to retail or direct to
consumer markets. Benefishial™ differentiates
itself from other OTC products as it is greater than 90% pure and
has a unique patented 6:1 EPA:DHA formulation. It contains the
highest content of Omega-3 fatty acids than any other OTC product
on the market. Benefishial™ is specifically
formulated to give the highest anti-inflammatory properties to
correct the imbalance created by the typical North American diet
that is high in Omega-6 (pro-inflammatory).
Benefishial™'s unique formulation is clinically shown
to increase blood levels of Omega-3. Increased Omega-3 levels have
been linked to the maintenance of a healthy body and mind.
Benefishial™ is third party tested and goes through a
five-step purification process to remove all toxins and fillers. It
is monitored for quality throughout the manufacturing process,
tested by third parties and is packaged using blister packaging to
maintain freshness. Benefishial™ contains the optimal
purity, ratio and dose of any Omega-3.
Benefishial™ provides a simple solution to a
number of health risk factors.
Also during the third Quarter the Company focused its efforts
and resources on the development of reagents for a rapid format
point-of-care (POC) diagnostic test that can easily identify
patients that are Omega-3 deficient at the physician's office,
clinics and pharmacies. "Having a test available to identify
patients that are Omega-3 deficient right in the doctor's office
will enhance our market opportunities tremendously," said Dr.
George Jackowski, Chief Scientific
Officer.
Financial Results:
For the three months ended September 30,
2014, the Company reported a loss of $1,632,052, or $0.02 per common share. This included
$97,200 in non-cash stock option
expenses, $156,145 in interest on
long-term debt and $378,018 in
accretion expense. In last year's second quarter, the loss was
$492,719, or $0.01 per common share.
"VASCAZEN® is selling in 36 states across the
US, despite the fact that our sales efforts to date have only
concentrated on three states. Even though the Company is not fully
capitalized to expand its own in-house sales force to a national
level, this shows that our medical food strategy and messaging is
resonating with healthcare practitioners and patients across the
country. This positive experience demonstrates the Company's
readiness for a true national co-marketing partner," stated Mr.
Eugene Bortoluzzi, Pivotal's CEO and
CFO. "Additionally, the Company is seeking product sales
opportunities in other countries, we continue to expand our patent
portfolio and the development of a point-of-care diagnostic that
tests for Omega-3 deficiency."
The audited consolidated financial statements, accompanying
notes thereto and Management's Discussion and Analysis for the
three months ended September 30,
2014, will be accessible on SEDAR www.sedar.com, CSE
www.cnsx.ca under the symbol "PVO" and OTCQX www.otcqx.com under
the symbol "PVTTF".
Additional Q3-2014 Operational Highlights:
- Superiority of VASCAZEN®'s Unique 6:1 Omega-3 formulation highlighted in
study published in PLOS ONE entitled "Redox-sensitive induction of
Src/PI3-kinase/Akt and MAPKs pathways activate eNOS in response to
EPA:DHA 6:1;
- Unique vasoprotective and antihypertensive effects of VASCAZEN
6:1 EPA:DHA presented as a poster entitled "Chronic oral intake of the omega 3
optimized formulation EPA:DHA 6:1 protects against angiotensin
II-induced hypertension and endothelial dysfunction in
rats," at European Society of Cardiology (ESC) Congress
2014;
- Publication of the results of the VASCAZEN®-REVEAL study in the
peer-reviewed journal Molecular and Cellular Biochemistry entitled
"Efficacy of a unique omega-3 formulation on the correction of
nutritional deficiency and its effects on cardiovascular disease
risk factors in a randomized controlled VASCAZEN®-REVEAL Trial;"
- Notice of Allowance for Pivotal's U.S. Patent Application
Serial Number 13/584,480 titled "STATIN and Omega-3 Fatty Acids for
Reduction of Apolipoprotein-B Levels" that includes claims intended
to protect VASCAZEN® and its formulation in conjunction with a Statin;
and
- Notice of Allowance for Pivotal's U.S. Patent Application
Serial Number 13/584,403 titled "Cholesterol Absorption Inhibitor
and Omega-3 Fatty Acids for the Reduction of Cholesterol and for
the Prevention or Reduction of Cardiovascular, Cardiac and Vascular
Events" that includes claims intended to protect VASCAZEN® and its formulation
in conjunction with at least one azetidinone cholesterol absorption
inhibitor.
About Pivotal Therapeutics Inc.
Pivotal Therapeutics is a publicly traded (OTCQX:PVTTF;
CSE: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. OMAZEN® is a pharmaceutical grade
Omega-3 providing over 90% pure Omega-3 in each capsule for the
maintenance of good health. OMAZEN® is a patented
product available for sale and distribution in Canada.
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® has been clinically shown to correct
an Omega-3 deficiency within eight weeks of treatment with positive
concomitant effects on the lipid profiles, mainly a 48% reduction
of triglycerides and an increase 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, uniquely formulated
Omega-3.
Disclosure Notice
The information contained in this document is as of
November 28, 2014. 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 CSE 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. The
CSE has not reviewed and does not accept responsibility for the
adequacy or accuracy of this information.
SOURCE Pivotal Therapeutics Inc.