Pivotal Therapeutics Announces First Quarter Financial Results

WOODBRIDGE, ON, June 1, 2015 /PRNewswire/ - 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 three months ended March 31, 2015.  All dollar amounts referenced herein are in Canadian dollars unless otherwise stated.

"Pivotal continues to deliver on its business strategies despite its limited financial resources," stated Mr. Eugenio Bortoluzzi, Pivotal's CEO and CFO. "The company is currently pursuing several leads for additional long-term capital.  In the short-term, the Company hopes to arrange a bridge financing to support the day-to- day operations until more permanent financing can be completed."

Operational Highlights for Q1 2015:

• Received final approval to conduct the POMEGA Phase IIa clinical trial with its PVT-100 drug candidate. PVT-100 uses VASCAZEN^®'s proprietary formulation for the stabilization of vulnerable plaque in patients undergoing carotid endarterectomy, a surgical procedure to remove material accumulated in the arteries to reduce the risk of stroke;
  
  
• Issuance of two patents, that were allowed during Q4 2014, U.S. Patent Number 8,951,514 related to the combination of VASCAZEN^® with key cholesterol lowering agents (statins) and U.S. Patent Number 8,952,000 related to the combination of VASCAZEN^® with cholesterol absorption inhibitors;
  
  
• Received Notice of Allowance for U.S. Patent Application Number 13/584,428 related to a kit for the dietary management of cardiovascular patients that includes VASCAZEN^® and an Omega-3 fatty acid diagnostic assay;
  
  
• Executed a memorandum of understanding with Korea Animal Medical Science Institute (KAMSI) and its newly created affiliate for the exclusive sales and distribution of the BeneFishial™ family of products in Korea;
  
  
• Received Health Canada approval to expand the indication of OMAZEN^® to include products with claims to maintain and support cardiovascular health and normal triglyceride levels.
  
  
• Pivotal and Mrs. Rachelle MacSweeney, Co-Founder, President and COO featured on CEO Clips on CBC's The Documentary Channel. CEO Clip available via the following link: http://www.b-tv.com/pivotal-therapeutics-ceo-clip/.

Financial Results

For the three months ended March 31, 2015 the Company reported a loss of $1.2 million, or $0.01 per common share, compared with a loss of $1.6 million, or $0.02 per common share for the three months ended March 31, 2014. Major contributors to the comparative net loss improvement of $421,385 were increases sales of $100,981, reduction in stock based compensation of $508,952, reduced salaries and benefits of $62,960 and a net expense reduction in other items of $81,834 offset by increases in accretion expense of $229,534 and interest on long term debt of $103,808.  The reduction in stock based compensation resulted from the Company not having issued any stock options during the three months ended March 31, 2015.  Sales for the three months ended March 31, 2015 are $153,513 as compared to $52,532 for the three months March 31, 2015.  The increase in sales is due in part to channel restocking.

The audited consolidated financial statements, accompanying notes thereto and Management's Discussion and Analysis for the three months ended March 31, 2015, 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".

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 for the professional market. BeneFishial™ is the first product in Pivotal's new nutraceutical product line, which has been specifically designed to be sold in the OTC direct to retail or direct to consumer markets.

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. 

About OMAZEN^®

OMAZEN^® is Pivotal's second commercial product to market and is available for sale and distribution for the professional over the counter (OTC) market in Canada. OMAZEN^® contains greater than 90% pure, pharmaceutical grade Omega-3 with a unique ratio of EPA to DHA for the maintenance of good health. OMAZEN^®, like all of Pivotal's products, is backed by clinical data and scientific support providing a superior alternative to what is currently available on the market.

About BeneFishial™

BeneFishial^™ was created as the cornerstone of our new nutraceutical product line, which will include prenatal, children, heart and animal health orientated products. BeneFishial^™ is designed to be sold as a nutraceutical in the OTC direct to retail or direct to consumer markets in both the U.S. and in Canada. BeneFishial^™ contains the highest content of Omega-3 fatty acids of any other OTC product on the market. It is specifically formulated to give the highest purity, highest anti-inflammatory properties and the best therapeutic effect for a healthy body and mind. It contains the optimal purity, ratio and dose of Omega-3 and is a simple solution to a number of health risk factors.

Disclosure Notice
The information contained in this document is as of June 1, 2015. 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. The CSE has not reviewed and does not accept responsibility for the adequacy or accuracy of this information.

SOURCE Pivotal Therapeutics Inc.

Related Links

www.pivotaltherapeutics.us