Pivotal Therapeutics announces accomplishments, financial results for Q3 2014

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Nov 29 2014

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.