WOODBRIDGE, ON, April 30, 2015 /PRNewswire/ - Pivotal
Therapeutics Inc. (OTCQX: PVTTF) (CSE: PVO), a specialty
pharmaceutical company with a focus on Omega-3 therapies for
cardiovascular disease (CVD) and overall health, announced its
operational highlights and financial results for the fiscal year
ended December 31, 2014. All
dollar amounts referenced herein are in Canadian dollars unless
otherwise stated.
"Pivotal's accomplishments in 2014 have been significant, with
the right strategic partners and additional capitalization in 2015,
investors can look forward to a more realistic valuation of the
Company," stated Mr. Eugenio
Bortoluzzi, Pivotal's CEO and CFO.
Highlights from 2014
- Received Notice of Allowance on its unique 6:1 EPA:DHA
formulation in conjunction with anti-obesity agents for the
reduction of body weight in cardiovascular disease patients and
diabetics;
- Announced the adjustment of terms, expansion and closing of a
debt financing, resulting in gross proceeds of CDN $7,743,580;
- Presented two posters discussing Omega-3 deficiency and
VASCAZEN®'s unique formulation to correct the
deficiency at the American Heart Association's Arteriosclerosis,
Thrombosis and Vascular Biology (ATVB) 2014 Scientific Sessions in
Toronto, Canada;
- Issuance of U.S. Patent 8,715,648 titled "Formulations
Comprising Omega-3 Fatty Acids and Anti-Obesity Agent for the
Reduction of Body Weight in CVD Patients and Diabetics";
- Entered into a Memorandum of Understanding to create a Joint
Venture with ACGT Corporation in an effort to explore commercial
opportunities in China;
- Publication by PLOS ONE reporting a study confirming
that the VASCAZEN® formulation is superior to the
other existing commercial products in the marketplace in terms of
sustained coronary vasodilation (increase of blood flow), which is
important for patients with Coronary Heart Disease who have
compromised coronary vessels;
- Presented a poster indicating that the chronic intake of
VASCAZEN®'s 6:1 EPA:DHA formulation prevented the
development of hypertension and endothelial dysfunction in a rodent
model at the 2014 Annual Meeting of the European Society of
Cardiology Congress in Barcelona,
Spain;
- Publication of the VASCAZEN®-REVEAL trial
showing the positive effects of VASCAZEN® in the
correction of an Omega-3 deficiency in cardiovascular patients is
available in the peer-reviewed journal titled Molecular and
Cellular Biochemistry (MCB) with open public access at
http://link.springer.com/article/10.1007/s11010-014-2132-1/fulltext.html;
- Received Notice of Allowance for U.S. Patent Application
13/584,480 titled "Statin and Omega-3 Fatty Acids for Reduction of
Apolipoprotein-B Levels";
- Received Notice of Allowance for U.S. Patent Application 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";
- Announced the creation of a new product line
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 formulation that is backed by clinical
data.
- Announced R&D efforts and resources used to develop
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
- Announced clearance by the French FDA of the clinical
evaluation part of the POMEGA Phase IIa trial protocol;
Subsequent to Year End
- Received final approval to conduct the POMEGA Phase
IIa clinical trial with its PVT-100 drug candidate.
PVT-100 uses VASCAZEN®'s proprietary
formulation for the stabilization of vulnerable plaque in patients
undergoing carotid endarterectomy, a surgical procedure to remove
material accumulated in the arteries to reduce the risk of
stroke;
- Issuance of two patents, that were allowed during Q4 2014, U.S.
Patent Number 8,951,514 related to the combination of
VASCAZEN® with key cholesterol lowering agents
(statins) and U.S. Patent Number 8,952,000 related to the
combination of VASCAZEN® with cholesterol
absorption inhibitors;
- Received Notice of Allowance for U.S. Patent Application Number
13/584,428 related to a kit for the dietary management of
cardiovascular patients that includes VASCAZEN®
and an Omega-3 fatty acid diagnostic assay;
- Executed a memorandum of understanding with Korea Animal
Medical Science Institute (KAMSI) and its newly created affiliate
for the exclusive sales and distribution of the
BeneFishial™ family of products in Korea;
- Received Health Canada approval to expand the indication of
OMAZEN® to include products with claims to
maintain and support cardiovascular health and normal triglyceride
levels.
2014 Financial Review
For the twelve months ended December 31,
2014 the Company reported a loss of $5.4 million, or $0.06 per common share, compared with a loss of
$3.0 million, or $0.04 per common share for the twelve months
ended December 31, 2013. Major items
contributing to the loss are increases in selling and marketing
expenses of $1,395,593 versus
$1,097,913 in the previous year,
stock based compensation of $1,037,294 versus $Nil in the previous year and
research and development expenses of $788,316 versus $454,443.
Sales for the three and twelve months ended December 31, 2014 are $107,728 and $306,596 respectively as compared to $75,859 and $303,530 for the three and twelve months ended
December 31, 2013. While annual
sales increased slightly compared to the previous year, fourth
quarter sales achieved an increase of 42% compared to the previous
year.
The audited consolidated financial statements, accompanying
notes thereto and Management's Discussion and Analysis for the year
ended December 31, 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".
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 for the professional
market. BeneFishial™ is the first product in Pivotal's new
nutraceutical product line, which has been specifically designed to
be sold in the OTC direct to retail or direct to consumer
markets.
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.
About OMAZEN®
OMAZEN® is Pivotal's second commercial product
to market and is available for sale and distribution for the
professional over the counter (OTC) market in Canada. OMAZEN® contains
greater than 90% pure, pharmaceutical grade Omega-3 with a unique
ratio of EPA to DHA for the maintenance of good health.
OMAZEN®, like all of Pivotal's products, is
backed by clinical data and scientific support providing a superior
alternative to what is currently available on the market.
About BeneFishial™
BeneFishial™ was created as the
cornerstone of our new nutraceutical product line, which will
include prenatal, children, heart and animal health orientated
products. BeneFishial™ is designed to be
sold as a nutraceutical in the OTC direct to retail or direct to
consumer markets in both the U.S. and in Canada. BeneFishial™
contains the highest content of Omega-3 fatty acids of any other
OTC product on the market. It is specifically formulated to give
the highest purity, highest anti-inflammatory properties and the
best therapeutic effect for a healthy body and mind. It contains
the optimal purity, ratio and dose of Omega-3 and is a simple
solution to a number of health risk factors.
Disclosure Notice
The information contained in this
document is as of April 30, 2015.
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.