WOODBRIDGE, ON, Nov. 29, 2013 /PRNewswire/ - Pivotal Therapeutics Inc. (OTCQX: PVTTF) (CNSX: PVO), a specialty pharmaceutical company with a focus on Omega-3 therapies
announced its third quarter financial results and operational
highlights for the three and nine months ended September 30, 2013.
For the three months and nine months ended September 30, 2013, the
Company reported sales of $60,839 and $227,670 respectively, as
compared to $29,428 and $59,155 for the three months and nine months
ended September 30, 2012. Net loss for the nine months ended September
30, 2013 is $1,997,672 or $0.03 per common share as compared to
$2,516,565 or $0.03 per common share in the previous year.
"We continue to receive positive feedback as existing and new
prescribers of VASCAZEN® are appreciating the benefits of correcting an Omega-3 Deficiency
(OM3D)," stated Mr. Eugene Bortoluzzi, Chief Executive Officer and
Chief Financial Officer. "We believe that the information we have
received in this limited launch phase, along with the additional
funding from the capital raise scheduled to close in the coming days,
positions us well for a broader VASCAZEN® launch in 2014".
The consolidated financial statements, accompanying notes and the
Management's Discussion and Analysis for the three and nine months
ended September 30, 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 for 2013:
Successfully completed the VASCAZEN®-REVEALTrial meeting 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 positive increase of HDL (good cholesterol) without
negative impact on the LDL-C (bad cholesterol) lipid profile;
Presented results of the VASCAZEN®-REVEALTrial at the American Heart Association's Arteriosclerosis, Thrombosis and
Vascular Biology (ATVB) 2013 Scientific Sessions;
Dr. Jackowski, Pivotal's founder, Chairman and Chief Scientific Officers
honoured with Queen Elizabeth'sDiamond 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;
Exhibited at the American College of Cardiology's 62nd Annual Scientific Session and Expo;
Presented results of the VASCAZEN®-REVEALTrial at the European Society of Cardiology (ESC) 2013;
Company to raise CDN $5,000,000 Debt Financing led by Crossover
Healthcare Fund, LLC;
Completed Equity Portion of Financing raising CDN $2,741,809 and
received $1,649,280 from Debt Financing to expand sales and marketing,
advance ongoing clinical trials, and for general working capital,
including business development;
Dr. John P. Nicholson Jr., MD, MBA, FACC appointed to the Company's
Board of Directors.
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.
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. 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.
The information contained in this document is as of November 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.