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Pivotal Therapeutics Announces Second Quarter Financial Results

2015-08-28 21:52 ET - News Release

(via Thenewswire.ca)



Woodbridge, Ontario / TheNewswire / August 28, 2015 - 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 six months ended June 30, 2015. All dollar amounts referenced herein are in Canadian dollars unless otherwise stated.

Operational Highlights for Q2 2015 :

  • -Received Notice of Allowance for U.S. Patent Application Number 13/584,428 related to a kit for the dietary management of cardiovascular patients with Cardiovascular Disease (CVD) who are deficient in blood EPA and DHA levels that includes VASCAZEN (R) 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 (TM) family of products in Korea;

    -Received Health Canada approval to expand the indication of OMAZEN (R) 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/

  • -Enrolled first patient in Pivotal's POMEGA Phase IIa clinical trial with PVT-100 .

The previously announced private equity financing is being received far better than anticipated and to facilitate this we have extended this offer. The Company is currently in negotiations with new investors.

Financial Results

For the six months ended June 30, 2015 the Company reported an increase in sales of 112% to $268,176 ($126,323 - 2014), a decrease in operating expenses of 55% to $1,603,162 ($3,539,190 - 2014) and a decrease of 30% in net loss to $2,646,253 ($3,786,445 - 2014).

The audited consolidated financial statements, accompanying notes thereto and Management's Discussion and Analysis for the six months ended June 30, 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 (R) 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 (R) is a pharmaceutical grade Omega-3 providing over 90% pure Omega-3 in each capsule for the maintenance of good health. OMAZEN (R) is a patented product available for sale and distribution in Canada for the professional market. BeneFishial (TM) 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 (R)

VASCAZEN (R) 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 (R) 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 (R) 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 (R)

OMAZEN (R) 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 (R) contains greater than 90% pure, pharmaceutical grade Omega-3 with a unique ratio of EPA to DHA for the maintenance of good health. OMAZEN (R) , 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 (TM)

BeneFishial (TM) was created as the cornerstone of our new nutraceutical product line, which will include prenatal, children, heart and animal health orientated products . BeneFishial (TM) 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 (TM) 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 August 28, 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 ability to obtain additional financing on acceptable terms; growth in costs and expenses; ability to compete with others who provide comparable products; risk that the Company's products will not gain widespread market acceptance. 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.

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Company Contacts:

Kristine DiMatteo

Communications and Public Relations Manager

Phone: 905-856-9797 ext. 231

E-Mail: kdimatteo@pivotaltherapeutics.us

www.pivotaltherapeutics.us

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