Pivotal Therapeutics Announces 2013 Financial Results

WOODBRIDGE, ON, April 30, 2014 /CNW/ - Pivotal Therapeutics Inc. (OTCQX: PVTTF) (CSE: 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, 2013. All dollar amounts referenced herein are in Canadian dollars unless otherwise stated.

Financial Review

Sales for the year ended 2013 totaled $303,530 versus $93,637 in 2012. The increase in sales is attributed to greater understanding, by healthcare practitioners, of an Omega-3 deficiency (OM3D) as an underlying risk factor of cardiovascular disease and how VASCAZEN®'s unique formulation can correct that deficiency.

"With the completion of the recent financing the Company is now in a position to execute on its commercialization plans for both VASCAZEN® and OMAZEN®," said Mr. Eugene Bortoluzzi, Chief Executive Officer and Chief Financial Officer. "We look forward to 2014 and the opportunity to further business development initiatives and bring to fruition research and development efforts."

For the twelve months ended December 31, 2013 the Company reported a loss of $3.0 million, or $0.04 per common share, compared with a loss of $3.6 million, or $0.05 per common share for the twelve months ended December 31, 2012. The decrease in loss of $745,342 is attributed to the improvement in revenues combined with a reduction in operating expenses.

The audited consolidated financial statements, accompanying notes thereto and Management's Discussion and Analysis for the year ended December 31, 2013, 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".

Highlights from 2013:

  • March 6, 2013 - The Company exhibited at the American College of Cardiology's 62nd annual scientific session and EXPO;

  • April 9, 2013 - VASCAZEN®-REVEAL trial top-line results accepted for presentation at the American Heart Association's Arteriosclerosis, Thrombosis and Vascular Biology (ATVB) 2013 Scientific Sessions;

  • April 30, 2013 - the Company presented top-line results from its recently concluded VASCAZEN®-REVEAL clinical trial in a poster 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 - Dr. George Jackowski, the Company's co-founder and Chairman, was awarded the Queen Elizabeth II Diamond Jubilee Medal for his significant contribution to the Canadian Biotech and Pharmaceutical Industries;

  • May 7, 2013 - the Company presented positive, statistically significant, top-line results from its VASCAZEN®-REVEAL trial announcing that it met primary and secondary endpoints and showed a 121% correction of an Omega-3 deficiency after only eight weeks of treatment;

  • October 2, 2013 - the Company announced the closing of the equity portion of the financing for $2,741,809 and the continuation of financing efforts by way of Convertible Promissory Notes for up to an additional $5,000,000;

  • October 7, 2013 - the Company received $1,649,280 under the debt financing;

  • November 1, 2013 - the Company announced the extension of the debt financing.

Highlights Subsequent to Year-end:

  • 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 financing.

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 April 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 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.

For further information:

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