WOODBRIDGE, ON, June 1, 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 three months
ended March 31, 2015. All
dollar amounts referenced herein are in Canadian dollars unless
otherwise stated.
"Pivotal continues to deliver on its business strategies despite
its limited financial resources," stated Mr. Eugenio Bortoluzzi, Pivotal's CEO and CFO. "The
company is currently pursuing several leads for additional
long-term capital. In the short-term, the Company hopes to
arrange a bridge financing to support the day-to- day operations
until more permanent financing can be completed."
Operational Highlights for Q1 2015:
- 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.
- Pivotal and Mrs. Rachelle
MacSweeney, Co-Founder, President and COO featured on CEO
Clips on CBC's The Documentary Channel. CEO Clip available via the
following link:
http://www.b-tv.com/pivotal-therapeutics-ceo-clip/.
Financial Results
For the three months ended March 31,
2015 the Company reported a loss of $1.2 million, or $0.01 per common share, compared with a loss of
$1.6 million, or $0.02 per common share for the three months ended
March 31, 2014. Major contributors to
the comparative net loss improvement of $421,385 were increases sales of $100,981, reduction in stock based compensation
of $508,952, reduced salaries and
benefits of $62,960 and a net expense
reduction in other items of $81,834
offset by increases in accretion expense of $229,534 and interest on long term debt of
$103,808. The reduction in
stock based compensation resulted from the Company not having
issued any stock options during the three months ended March 31, 2015. Sales for the three months
ended March 31, 2015 are $153,513 as compared to $52,532 for the three months March 31, 2015. The increase in sales is
due in part to channel restocking.
The audited consolidated financial statements, accompanying
notes thereto and Management's Discussion and Analysis for the
three months ended March 31, 2015,
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 June 1, 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.