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Pivotal Therapeutics Inc. Announces First Quarter 2013 Financial Results


5/29/2013 11:06:30 AM

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WOODBRIDGE, ON, May 29, 2013 /PRNewswire/ - Pivotal Therapeutics Inc. (OTCQX: PVTTF) (CNSX: PVO), a specialty pharmaceutical company with a focus on Omega-3 therapies for cardiovascular disease (CVD) and overall health, announced its financial results and operational highlights for the three months ended March 31, 2013. All dollar amounts referenced herein are in Canadian dollars unless otherwise stated.

For the three months ended March 31, 2013 the Company reported a loss of $783,436, or $0.01 per common share, compared with a loss of $831,090 or $0.01 per common share for the three months ended March 31, 2012. At March 31, 2013, Pivotal's working capital totaled $493,895 compared with $452,914 at December 31, 2012.

"Our pilot marketing program for VASCAZEN continues to gain traction, with initial sales up more than 200% from the previous quarter. Furthermore, the pilot program continues to provide valuable information which we are incorporating into our plans for our full launch of VASCAZEN in 2013," said Mr. Eugene Bortoluzzi Chief Executive Officer and Chief Financial Officer. "After presenting our positive results from our recently concluded VASCAZEN®-REVEAL clinical trial, healthcare professionals are realizing the benefits of Vascazen® and how treating an Omega-3 deficiency can address risk factors for cardiovascular patients."

The audited consolidated financial statements, accompanying notes to the audited thereto and Management's Discussion and Analysis for the three months ended March 31, 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 since December 31, 2012

  • March 6, 2013 - Pivotal exhibited at the American College of Cardiology's 62nd Annual Scientific Session and Expo;
  • April 9, 2013 - Vascazen® -Top line results accepted for presentation at the American Heart Association's ATVB 2013 Scientific Sessions;
  • April 30, 2013 - Pivotal announced 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 Sessions;
  • May 2, 2013 - Pivotal's founder, Chairman and Chief Scientific Officers Dr. Jackowski 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;
  • May 7, 2013 - VASCAZEN®- REVEAL trial meets 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 raise of HDL without negative impact on the LDL-C lipid profile.

Pivotals Goals for 2013:

  • Advance commercialization of Vascazen®with full launchin the U.S.;
  • Expansion of the sales & marketing team;
  • Initiation of new clinical trials;
  • Completion of existing clinical trials for Vascazen®and 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.

Notice of Annual General Meeting

Pivotal Therapeutics Inc. will hold its Annual General Meeting of Shareholders at 10:00 AM on June 26, 2013 at the registered office of the Company, 81 Zenway Blvd., Unit 10, Woodbridge, Ontario.

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® is the second to market prescription only Omega-3 in the U.S. and is available by prescription nationwide.

VASCAZEN® has been clinically shown to correct an Omega-3 deficiency within 8 weeks of treatment with positive concomitant effects on the lipid profiles, mainly a 48% reduction of triglycerides and a raise 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. OMAZENTM is a prescription grade Omega-3 providing >90% total Omega-3 in each capsule with a unique 6:1 ratio of EPA:DHA. OMAZENTM is a patented product available for sale and distribution in Canada.

Disclosure Notice
The information contained in this document is as of May 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.



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