Pivotal Therapeutics Announces 2012 Financial Results

WOODBRIDGE, ON, April 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 operational highlights and financial results for the fiscal year ended December 31, 2012.  All dollar amounts referenced herein are in Canadian dollars unless otherwise stated.

Financial Review

For the twelve months ended December 31, 2012 the company reported a loss of $3.6 million, or $0.05 per common share, compared with a loss of $3.8 million, or $0.06 per common share for the twelve months ended December 31, 2011. The decrease in loss of $182,769 resulted from an increase in sales netted against a reduction in operating expenses.

"The company is pleased to report the realization of revenues in it's first year of commercialization of VASCAZEN®," said Mr. Eugene Bortoluzzi Chief Executive Officer and Chief Financial Officer. "As the second prescription only Omega-3 to the market, VASCAZEN® has seen positive growth into the first quarter of 2013. We at Pivotal continue to expand our Sales and Marketing efforts to increase awareness of our products throughout the medical community."

At December 31, 2012, Pivotal's working capital position totaled $452,914, compared with $1.9 million at December 31, 2011. The increase in sales and marketing activities leading to the establishment of a dedicated sales force has contributed greatly to the decrease in working capital.

The audited consolidated financial statements, accompanying notes to the audited thereto and Management's Discussion and Analysis for the year ended December 31, 2012, will be accessible on Pivotalʼs website at www.pivotaltherapeutics.us and on SEDAR www.sedar.com.

Highlights from 2012:

  • February 22 - the Company filed five international patent filings covering 142 countries;
  • February 29 - the Company presented at the 61st Annual Scientific Session and Expo of the American College of Cardiology;
  • March 8 - Standard and Poors Capital IQʼs Market Access Program began coverage of the Company;
  • April 3 - the Company began trading in the U.S. on the OTC Markets' QX Marketplace, under the symbol PVTTF;
  • May 22- the Company announced first prescription sales in the U.S.;
  • June 25 - the Company announced U.S. Institutional Private Placement for $5M CDN;
  • August 9 - the Company announced that data from a scientific study, presented at the 17th World Congress On Heart Disease demonstrated the superiority of Vascazen®'s unique formulation;
  • August 23 - the Company announced that further data presented at the European Society of Cardiology Congress, demonstrated the superiority of Vascazen®'s unique formulation;
  • August 23 -the Company announced it generated positive feedback at the European Society of Cardiology Congress;
  • October 9 - the Company announced it exhibited at the 2012 Cardiometabolic Health Congress;
  • October 26 - the Company filed two additional provisional US and International patents covering certain aspects of its core product technologies;
  • November 5 - the Company announced it exhibited at the American Heart Associations (AHA) Scientific Sessions.
  • November 29- the Company announced its Q3 financial results;

Highlights Subsequent to Year-end:

  • March 6, 2013 - the Company announced it exhibited at the American College of Cardiology's 62nd Annual Scientific Session and Expo;
  • April 9, 2013 - the Company announced that Vascazen® - meets primary endpoint in REVEAL trial - Top line results accepted for presentation at the American Heart Association's ATVB 2013 Scientific Sessions.

Pivotalʼs Goals for 2013:

  • Advance commercialization of Vascazen® in 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 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 therapy available in the U.S. and is available by prescription nationwide.

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.

Disclosure Notice

The information contained in this document is as of April 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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