Pivotal Therapeutics Inc. , 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 endedย March 31, 2014. ย All dollar amounts referenced herein are in Canadian dollars unless otherwise stated.
Financial Results
For the three months endedย March 31, 2014, the Company reported a loss ofย $1,613,667, orย $0.02 per common share.ย This includedย $508,952 in non-cash expenses related to the awarding of stock options in the period.ย In last year’s first quarter, the loss was ย $783,436, orย $0.01 per common share.
The Company ended the 2014 first quarter in a significantly improved financial position.ย Atย March 31, 2014, Pivotal’s cash totaledย $4,617,305 compared withย $487,199 atย 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.ย 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.ย While still somewhat constrained in that respect, we are now in a position to start implementing our growth strategy.ย 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 endedย March 31, 2014, will be accessible on SEDARย www.sedar.com, CSEย www.cnsx.ca under the symbol “PVO” and OTCQXย www.otcqx.com under the symbol “PVTTF”.
Operational Highlights Sinceย 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 CDNย $7.7 million to furtherย Vascazenยฎcommercialization;
- March 14, 2014 andย 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;ย
- April 23, 2014 โ The Company announces the resignation of two directors, Dr.ย John P. Nicholson Jr. and Mr.ย James Connolly, both nominees of Crossover Healthcare Fund, LLC.;ย
- May 1 andย May 6 2014 โ the Company announced the presentation of two posters at the American Heart Association’s Arteriosclerosis, Thrombosis and Vascular Biology (ATVB) 2014 Scientific Sessions inย Toronto, Ontario, Canada,ย May 1-3, 2014;ย
- May 7, 2014 โ the Company announced the issuance of U.S. Patentย 8,715,648 for its Unique 6:1 EPA:DHA formulation;ย
- May 13, 2014 โ 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 forย Vascazenยฎ;ย
- May 14, 2014 โ 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.
Pivotalสผs Goals for 2014:
- Drive top-line revenues;
- Develop a point-of-care diagnostic test to measure Omega-3 deficiency (OM3D);
- Advance commercialization ofย Vascazenยฎ in the U.S. and internationally;
- Advance commercialization ofย OMAZENยฎ inย 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 specialty pharmaceutical company with a focus on cardiovascular disease and overall health. Pivotal Therapeutics’ lead productย VASCAZENยฎ 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.ย OMAZENยฎ is a pharmaceutical grade Omega-3 providing over 90% pure Omega-3 in each capsule for the maintenance of good health.ย OMAZENยฎ is a patented product available for sale and distribution inย Canada.
About VASCAZENยฎ
VASCAZENยฎ 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.ย VASCAZENยฎ 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.
VASCAZENยฎ 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.ย ย ย VASCAZENยฎ‘s results were achieved with a dose of 3 grams of EPA and DHA per day of a prescription grade, high purity Omega-3.
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SOURCE Pivotal Therapeutics Inc.
