Pivotal Therapeutics announces second quarter 2013 financial results and corporate update

C.PVO

WOODBRIDGE, ON, Aug. 28, 2013 /CNW/ - 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 second quarter financial results for the three and six months ended June 30, 2013.

For the three months ended June 30, 2013 the Company reported sales of $93,189 versus $26,408 over the same period in the previous year. Net loss for the period is $721,517 or $0.01 per common share as compared to $874,313 or $0.01 per common share in the previous year.

"I am very pleased to report continued increasing sales of VASCAZEN®," said Mr. Eugene Bortoluzzi, Chief Executive Officer and Chief Financial Officer. "A growing number of physicians and health care professionals are realizing the advantages of treating an Omega-3 deficiency by using VASCAZEN® and are impressed by the results they are seeing."

The consolidated financial statements, accompanying notes and the Management's Discussion and Analysis for the three and six months ended June 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 also notes the departure of Mr. Giuseppe Simeone, who stepped down as a director of the Company effective August 27, 2013.  Pivotal wishes to acknowledge and thank Mr. Simeone for his contributions and guidance since the Company went public and to wish him all the best in his future endeavours.

Pivotal Highlights for the First Half of 2013:

  • Sales increased by 27% in the second quarter of 2013;

  • Successfully completed the VASCAZEN®-REVEAL Trial 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®-REVEAL Trial 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's Diamond 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.

Pivotalʼs Goals for 2013 include:

  • Advancement of commercialization of Vascazen®;
  • 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;
  • Commercialization of OMAZENTM in Canada;
  • Presentations to the Investment community to increase awareness;
  • Presentations and attendance at scientific meetings.

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 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. OMAZENTM is a pharmaceutical grade Omega-3 providing over 90% pure Omega-3 in each capsule for the maintenance of good health. OMAZENTM is a patented product available for sale and distribution in Canada.

Disclosure Notice
The information contained in this document is as of August 28, 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.

Company Contacts:

Rachelle MacSweeney
President and Chief Operating Officer
Phone: 905-856-9797
E-Mail: rmacsweeney@pivotaltherapeutics.us

Kristine DiMatteo
Communications and Public Relations Manager
Phone: 905-856-9797 ext. 231
E-Mail: kdimatteo@pivotaltherapeutics.us

www.pivotaltherapeutics.us 

Copyright CNW Group 2013

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