WOODBRIDGE, ON, April 30, 2014 /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, 2013. All dollar amounts referenced herein are in Canadian
dollars unless otherwise stated.
Sales for the year ended 2013 totaled $303,530 versus $93,637 in 2012.
The increase in sales is attributed to greater understanding, by
healthcare practitioners, of an Omega-3 deficiency (OM3D) as an
underlying risk factor of cardiovascular disease and how VASCAZEN®'sunique formulation cancorrect that deficiency.
"With the completion of the recent financing the Company is now in a
position to execute on its commercialization plans for both VASCAZEN® and OMAZEN®," said Mr. Eugene Bortoluzzi, Chief Executive Officer and Chief
Financial Officer. "We look forward to 2014 and the opportunity to
further business development initiatives and bring to fruition research
and development efforts."
For the twelve months ended December 31, 2013 the Company reported a
loss of $3.0 million, or $0.04 per common share, compared with a loss
of $3.6 million, or $0.05 per common share for the twelve months ended
December 31, 2012. The decrease in loss of $745,342 is attributed to
the improvement in revenues combined with a reduction in operating
The audited consolidated financial statements, accompanying notes
thereto and Management's Discussion and Analysis for the year ended
December 31, 2013, 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".
Highlights from 2013:
- March 6, 2013 - The Company exhibited at the American College of
Cardiology's 62nd annual scientific session and EXPO;
- April 9, 2013 - VASCAZEN®-REVEAL trial top-line results accepted for presentation at the American Heart
Association's Arteriosclerosis, Thrombosis and Vascular Biology (ATVB)
2013 Scientific Sessions;
- April 30, 2013 - the Company presented top-line results from its
recently concluded VASCAZEN®-REVEAL clinical trial in a poster 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
- May 2, 2013 - Dr. George Jackowski, the Company's co-founder and
Chairman, was awarded the Queen Elizabeth II Diamond Jubilee Medal for
his significant contribution to the Canadian Biotech and Pharmaceutical
- May 7, 2013 - the Company presented positive, statistically significant,
top-line results from its VASCAZEN®-REVEAL trial announcing that it met primary and secondary endpoints and showed
a 121% correction of an Omega-3 deficiency after only eight weeks of
- October 2, 2013 - the Company announced the closing of the equity
portion of the financing for $2,741,809 and the continuation of
financing efforts by way of Convertible Promissory Notes for up to an
- October 7, 2013 - the Company received $1,649,280 under the debt
- November 1, 2013 - the Company announced the extension of the debt
Highlights Subsequent to Year-end:
- January 29, 2014 - The Company announced a Notice of Allowance for the
patent entitled "Formulations Comprising Omega-3 Fatty Acids and
Anti-Obesity Agent for the Reduction of Body Weight in Cardiovascular
Disease Patients (CVD) and Diabetics"
- March 4, 2014 - The Company closed the debt financing and receives over
CDN $7.7 million to further Vascazen® commercialization;
- March 14, 2014 and April 8, 2014 - The Company awarded stock options
that were granted previously to certain of its directors, officers,
employees and consultants in recognition of their contributions made in
2012 and 2013 and were awaiting the conclusion of the financing.
Pivotals Goals for 2014:
Drive top-line revenues;
Develop a point-of-care diagnostic test to measure Omega-3 deficiency
Advance commercialization of Vascazen®in the U.S. and internationally;
Advance commercialization of OMAZEN®in Canada;
Expansion of the sales & marketing initiatives;
Initiation of new clinical trials;
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.
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.
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 Omega-3.
The information contained in this document is as of April 30, 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 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.