Pivotal Therapeutics Announces First Quarter Financial Results

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.