Pivotal Therapeutics Announces Third Quarter Accomplishments and Financial Results

WOODBRIDGE, ON, Nov. 28, 2014 /PRNewswire/ - Pivotal Therapeutics Inc. (OTCQX:PVTTF; CSE:PVO), ("Pivotal" or the "Company"), a specialty pharmaceutical company with a focus on Omega-3 therapies for cardiovascular disease (CVD) and overall health, announced its accomplishments and financial results for the three months ended September 30, 2014.  All dollar amounts referenced herein are in Canadian dollars unless otherwise stated.

During the third quarter the Company expanded its product line to address new market segments that include the over-the-counter (OTC) marketplace.  Pivotal created Benefishial™ specifically to be sold in the OTC direct to retail or direct to consumer markets.  Benefishial™ differentiates itself from other OTC products as it is greater than 90% pure and has a unique patented 6:1 EPA:DHA formulation. It contains the highest content of Omega-3 fatty acids than any other OTC product on the market. Benefishial™ is specifically formulated to give the highest anti-inflammatory properties to correct the imbalance created by the typical North American diet that is high in Omega-6 (pro-inflammatory). Benefishial™'s unique formulation is clinically shown to increase blood levels of Omega-3. Increased Omega-3 levels have been linked to the maintenance of a healthy body and mind. Benefishial™ is third party tested and goes through a five-step purification process to remove all toxins and fillers. It is monitored for quality throughout the manufacturing process, tested by third parties and is packaged using blister packaging to maintain freshness. Benefishial™ contains the optimal purity, ratio and dose of any Omega-3.  Benefishial™ provides a simple solution to a number of health risk factors.

Also during the third Quarter the Company focused its efforts and resources on the development of reagents for a rapid format point-of-care (POC) diagnostic test that can easily identify patients that are Omega-3 deficient at the physician's office, clinics and pharmacies. "Having a test available to identify patients that are Omega-3 deficient right in the doctor's office will enhance our market opportunities tremendously," said Dr. George Jackowski, Chief Scientific Officer.

Financial Results:

For the three months ended September 30, 2014, the Company reported a loss of $1,632,052, or $0.02 per common share.  This included $97,200 in non-cash stock option expenses, $156,145 in interest on long-term debt and $378,018 in accretion expense. In last year's second quarter, the loss was $492,719, or $0.01 per common share.

"VASCAZEN^® is selling in 36 states across the US, despite the fact that our sales efforts to date have only concentrated on three states. Even though the Company is not fully capitalized to expand its own in-house sales force to a national level, this shows that our medical food strategy and messaging is resonating with healthcare practitioners and patients across the country. This positive experience demonstrates the Company's readiness for a true national co-marketing partner," stated Mr. Eugene Bortoluzzi, Pivotal's CEO and CFO. "Additionally, the Company is seeking product sales opportunities in other countries, we continue to expand our patent portfolio and the development of a point-of-care diagnostic that tests for Omega-3 deficiency."

The audited consolidated financial statements, accompanying notes thereto and Management's Discussion and Analysis for the three months ended September 30, 2014, 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".

Additional Q3-2014 Operational Highlights:

• Superiority of VASCAZEN^®'s Unique 6:1 Omega-3 formulation highlighted in study published in PLOS ONE entitled "Redox-sensitive induction of Src/PI3-kinase/Akt and MAPKs pathways activate eNOS in response to EPA:DHA 6:1;
• Unique vasoprotective and antihypertensive effects of VASCAZEN 6:1 EPA:DHA presented as a poster entitled "Chronic oral intake of the omega 3 optimized formulation EPA:DHA 6:1 protects against angiotensin II-induced hypertension and endothelial dysfunction in rats," at European Society of Cardiology (ESC) Congress 2014;
• Publication of the results of the VASCAZEN^®-REVEAL study in the peer-reviewed journal Molecular and Cellular Biochemistry entitled "Efficacy of a unique omega-3 formulation on the correction of nutritional deficiency and its effects on cardiovascular disease risk factors in a randomized controlled VASCAZEN^®-REVEAL Trial;"
• Notice of Allowance for Pivotal's U.S. Patent Application Serial Number 13/584,480 titled "STATIN and Omega-3 Fatty Acids for Reduction of Apolipoprotein-B Levels" that includes claims intended to protect VASCAZEN^® and its formulation in conjunction with a Statin; and
• Notice of Allowance for Pivotal's U.S. Patent Application Serial Number 13/584,403 titled "Cholesterol Absorption Inhibitor and Omega-3 Fatty Acids for the Reduction of Cholesterol and for the Prevention or Reduction of Cardiovascular, Cardiac and Vascular Events" that includes claims intended to protect VASCAZEN^® and its formulation in conjunction with at least one azetidinone cholesterol absorption inhibitor.

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, uniquely formulated Omega-3.

Disclosure Notice

The information contained in this document is as of November 28, 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 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