WOODBRIDGE,
ON, May 30, 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 operational highlights and
financial results for the three months ended March 31, 2014. All dollar amounts
referenced herein are in Canadian dollars unless otherwise
stated.
Financial Results
For the three months ended March 31, 2014, the Company reported a loss of
$1,613,667, or $0.02 per common share. This included
$508,952 in non-cash expenses related
to the awarding of stock options in the period. In last
year's first quarter, the loss was $783,436, or $0.01 per common share.
The Company ended the 2014 first quarter in a
significantly improved financial position. At March 31, 2014, Pivotal's cash totaled
$4,617,305 compared with $487,199 at December 31,
2013.
"Going into 2014, we mapped out an aggressive
agenda which included the expansion of our sales, marketing,
reimbursement support and R&D activities to help increase our
commercial footprint and reach a much larger doctor and patient
population," commented Mr. Eugene
Bortoluzzi, Pivotal's CEO and CFO. "However, until late in
the first quarter, a lack of available financial resources delayed
our ability to execute those plans. While still somewhat
constrained in that respect, we are now in a position to start
implementing our growth strategy. We look forward to updating
our stakeholders as we progress throughout the rest of the
year."
The audited consolidated financial statements,
accompanying notes thereto and Management's Discussion and Analysis
for the three months ended March 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".
Operational Highlights Since December
2013:
- 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
aforementioned debt financing;
- April 23, 2014 – The Company
announces the resignation of two directors, Dr. John P. Nicholson Jr. and Mr. James Connolly, both nominees of Crossover
Healthcare Fund, LLC.;
- May 1 and May 6 2014 – the Company announced the
presentation of two posters at the American Heart Association's
Arteriosclerosis, Thrombosis and Vascular Biology (ATVB) 2014
Scientific Sessions in Toronto, Ontario,
Canada, May 1-3, 2014;
- May 7, 2014 – the Company
announced the issuance of U.S. Patent 8,715,648 for its
Unique 6:1 EPA:DHA formulation;
- May 13, 2014 – the Company
engaged Brandkarma LLC., an award winning, US-based, healthcare
marketing and brand specialist with global expertise to support the
Company's commercialization strategy for
Vascazen®;
- May 14, 2014 – the Company
announced changes to its Board designed to increase its
independence and enhance Pivotal's corporate governance at this
stage of the Company's development.
Pivotalʼs Goals for 2014:
- Drive top-line revenues;
- Develop a point-of-care diagnostic test to measure Omega-3
deficiency (OM3D);
- 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.
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
Omega-3.
Disclosure Notice
The information
contained in this document is as of May 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 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. CSE has not
reviewed and does not accept responsibility for the adequacy or
accuracy of this information.
SOURCE Pivotal Therapeutics Inc.