Pivotal Therapeutics Inc.
CNSX : PVO

Pivotal Therapeutics Inc.

February 02, 2012 12:24 ET

Pivotal Therapeutics Inc. Review and Update from the CEO

WOODBRIDGE, ONTARIO--(Marketwire - Feb. 2, 2012) - Pivotal Therapeutics Inc. (CNSX:PVO), a specialty pharmaceutical company with a focus on the treatment of cardiovascular disease and overall health, today reports a Review and Update from the CEO.

Dear Fellow Shareholders

I welcome this opportunity to briefly review the progress our Company has made during 2011 and our objectives for 2012.

Pivotal accomplished a number of key milestones during 2011; the two most significant being our commercial launch of VASCAZEN, for the US market, and the listing of our shares for public trading on the Canadian National Stock Exchange (CNSX).

Financial Update

I am pleased to report that since completing our reverse takeover in May 2011, which led to our public listing on the CNSX where we raised $3.1 million, we have been successful in raising an additional $2.6 million through a Warrant call in September. These capital raises will continue to support the progress of our commercialization programs. We are appreciative of the confidence investors have in the potential of our business and we will continue to look for value added investors in order to fund our corporate initiatives going forward.

Business Development

During 2011 the company achieved all of its stated business development milestones:

  • Taking our company public through a reverse takeover,
  • Filing five US provisional patents for our unique formulation and for combinations with other therapies,
  • Securing an exclusive supply chain for the production of VASCAZEN,
  • Launching VASCAZEN clinical trials (Open label study and REVEAL trial,
  • Initiation of efforts with research groups to enhance our product properties and intellectual property,
  • Successful completion of a Warrant call, leading to a second round of financing,
  • Assessment and hiring of a Contract Sales Organization,
  • Obtaining NPN license allowing for the sale of OMAZEN in Canada,
  • Introduction of Pivotal at the Canadian Cardiovascular Congress,
  • Launching VASCAZEN in the US at the American Heart Association Conference,
  • Application to list VASCAZEN on US pharmacy reference guide,
  • Training a dedicated contract sales force for our US market launch,
  • Launching contract sales force in January 2012.

A key component of our business strategy is to maintain and establish collaborations with partners that will assist Pivotal in the execution of our commercialization, marketing and distribution programs. We are consistently evaluating and speaking with industry leaders and look forward to updating you on our progress.

2012 Milestones

What can the shareholders expect from our company during 2012?

  • Expansion of our product pipeline,
  • Positive results from our REVEAL trial,
  • Expansion of our worldwide patent portfolio,
  • Positive results from our commercial sales efforts,
  • Investigation of licensing opportunities,
  • Expansion of our contract sales force,
  • Issuance of scientific publications validating the efficacy of our products and concepts,
  • Working towards being listed on a US exchange,
  • Continued presentation of our company to new individual and institutional investors,
  • Continued presentation of our company to investment analysts for potential research coverage in order to more accurately reflect a fair valuation of the company and its stock,
  • Continued presentation of our company to investment bankers in order to gage funding and corporate development opportunities,
  • Continued communication of our progress to you on a timely basis.

Summary

Your Pivotal management team, which is a significant shareholder in the company, is proud of its 2011 achievements and looks forward to delivering on additional critical milestones in 2012. We are confident that our efforts will drive shareholder value and improve the quality of life for those individuals that will benefit from the usage of our products. Please visit our website at www.pivotaltherapeutics.us to read more about the opportunities we will be pursuing.

Please feel free to contact me with any questions or comments you may have.

Sincerely,

Eugene Bortoluzzi
Chief Executive Officer
Pivotal Therapeutics, Inc.

About Pivotal Therapeutics Inc.

With offices in Toronto, Canada and Boca Raton, Florida, Pivotal Therapeutics is a publicly traded (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 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.

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 the 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.

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.

Disclosure Notice

The information contained in this document is as of Febraury 2, 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.

Contact Information