Pivotal Therapeutics Inc.

Pivotal Therapeutics Inc.

April 30, 2012 19:09 ET

Pivotal Therapeutics Announces 2011 Financial Results

WOODBRIDGE, ONTARIO--(Marketwire - April 30, 2012) - Pivotal Therapeutics Inc. (OTCQX:PVTTF)(CNSX:PVO), a specialty pharmaceutical company with a focus on the treatment of cardiovascular disease, today announced its operational highlights and financial results for the fiscal year ended December 31, 2011. All dollar amounts referenced herein are in Canadian dollars unless otherwise stated.

Financial Review

The period of twelve months ended December 31, 2011 represents the Company's first annual filing, as an amalgamated entity, and its first full year of operations. Comparative figures are for the three months ended December 31, 2010, as the Company was not in operation prior to October 1, 2010. The loss for the year ended December 31, 2011 was $3.8 million, or $0.06 per common share, compared with a loss of $195 thousand, or $0.01 per common share for the three months ended December 31, 2010.

At December 31, 2011, Pivotals' cash position totaled $1.6 million, compared with $1.3 million at December 31, 2010. The increase in cash during the year ended December 31, 2011, is due primarily to the successful exercise of 10,466,392 common stock purchase warrants for net proceeds of $2,616,598.

The audited consolidated financial statements, accompanying notes to the audited thereto and Management's Discussion and Analysis for the year ended December 31, 2011, will be accessible on Pivotal's website at www.pivotaltherapeutics.us and on SEDAR.

Highlights from 2011:

  • April 7th - completing a reverse take over of a public company (Media Script Marketing Inc.);
  • May 19th - Commences trading on the Canadian National Stock Exchange (CNSX) under the symbol PVO;
  • June 2nd - opening of the Company's US commercialization office located in the Research Park at Florida Atlantic University;
  • June 8th - commencement of Clinical Trials to assess the effectiveness of the Company's lead product Vascazen™;
  • July 12th - filing five US provisional patents for our unique formulation and for combinations with other therapies;
  • Sept 7th - presentation at the Rodman & Renshaw Annual Global Investment Conference in New York;
  • September 12th - expansion of the REVEAL ("A randomized, Placebo-Controlled Study of Vascazen™ in Patients With Deficient Blood Omega-3 Fatty Acid levels") clinical trials. The clinical trial will assess the effectiveness of Pivotal's lead therapeutic Vascazen™;
  • September 22nd - the successful exercise of 10,466,392 common stock purchase warrants resulting in net proceeds of $2,616,598;
  • September 27th - the Company announced the release of positive results from its open label study of Vascazen™;
  • October 6th - the engagement of Phoenix Healthcare LLC as its contract sales force partner. The engagement covers the recruitment and development of a dedicated contract sales force;
  • November 22nd - the North American Launch of its lead therapeutic Vascazen™, at the American Heart Association Scientific Sessions 2011 in Orlando, Florida;
  • November 24th - expansion of the Board of Directors with the appointment of Mr. John Gebhardt. Mr. Gebhardt has worked for over thirty years in the US financial and securities industry and most recently was Managing Director at Knight Capital Markets in New York;
  • December 5th - the Canadian Natural Health Products Directorate ("NHPD") concluded that Omazen™, a second product for the Company, is in compliance, pursuant to Section 7 of the Natural Health Products Regulations, and issued license NPN 80028433 allowing for the sale of such product in Canada.

Highlights Subsequent to Year-end:

  • February 22, 2012 - the Company files for five international patent filings covering 142 countries;
  • February 29, 2012 - the Company's presentation at the 61st Annual Scientific Session and Expo of the American College of Cardiology;
  • March 8, 2012 - Standard and Poors Capital IQ's Market Access Program begins coverage of the Company;
  • April 3, 2012 - the Company began trading on the US exchange, OTC Markets' QX Marketplace, under the symbol PVTTF.

Pivotal's Goals for 2012

  • Raise additional capital to assist with the further commercialization of Vascazen™;
  • Expansion of intellectual property portfolio;
  • Investigate international licensing opportunities;
  • Completion of clinical trials and publication of results;
  • Publish scientific data validating the efficacy of Pivotal's products and concepts;
  • Expansion of product offerings.

Notice of Annual General Meeting

Pivotal Therapeutics Inc. will hold its Annual General Meeting of Shareholders at 10:00 AM on May 29, 2012 at the registered office of the Company, 81 Zenway Blvd., Unit 10, Woodbridge, Ontario.

About Pivotal Therapeutics Inc.

With offices in Toronto, Canada and Boca Raton, Florida, Pivotal Therapeutics is a publicly traded (OTCQX:PVTTF)(CNSX:PVO) specialty pharmaceutical company with a focus on the treatment of 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 (EPA) and Docosahexaenoic (DHA) to levels associated with reduced risk of cardiovascular complications.

VASCAZEN is a >90% pure, proprietary EPA:DHA fatty acid formulation, protected by a series of both issued and pending US and foreign patents and commercialized by prescription only. This unique formulation will provide the cornerstone upon which a family of cutting edge combination products, with efficacy across a broad spectrum of cardiac care, will be commercialized.

OMAZEN is a >90% pure, proprietary EPA:DHA fatty acid formulation commercialized for sale and distribution in Canada for the maintenance of good health through elevating Omega-3 fatty acid levels. The unique formulation and dosage will be available to patients and consumers who realize the health benefits of Omega-3 supplementation with a quality product.

Disclosure Notice

The information contained in this document is as of April 30, 2012. 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.

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