SOURCE: Pivot Pharmaceuticals Inc.

Pivot Pharmaceuticals Inc.

February 29, 2016 08:00 ET

Pivot Pharmaceuticals Provides Shareholder Update

BOSTON, MA and VANCOUVER, BC--(Marketwired - Feb 29, 2016) - Pivot Pharmaceuticals Inc. (OTCQB: PVOTF) ("Pivot" or the "Company"), an emerging biotechnology company engaged in the development of therapeutics to address unmet medical needs in women's health, is pleased to provide the following shareholder update.

Pivot has had a very busy start in 2016 after a year filled with many achievements in 2015. The Company would like to thank its shareholders for their investment, engagement, and support of our efforts to develop and bring innovative and novel drugs to market.

Highlights:

  • Acquisition of IndUS results in strengthened drug pipeline and IP Estate
  • Advancement of Pivot's anticancer drugs towards clinical trials in 2016
  • Actively seeking to license or acquire a late-stage asset
  • Board and management team solidified with new members
  • Company to seek up-listing to Nasdaq Stock Market

Strengthening of Product Pipeline

In Q3 2015 Pivot completed the acquisition of a privately-held, Boston-based, emerging biotech company, IndUS Pharmaceuticals. As a result, Pivot now has a pipeline of novel anticancer drug candidates that have shown excellent promise in preclinical studies for the treatment of refractory cancers in women such as metastatic endometrial cancer (mEC) and basal-like-triple-negative breast cancer (BL-TNBC). This represents an "orphan" drug opportunity for the Company allowing for a longer exclusivity period following marketing approval of the drugs. The immediate addressable market size for these two anticancer drugs is estimated to be $500 million annually. The Company has initially prioritized two novel drug candidates from its portfolio of multiple anticancer molecules for these two indications (PVT-005 and PVT-006). Pivot has also identified a 'fast follower' molecule (PVT-007) to diversify and broaden its pipeline of drug candidates.

Intellectual Property Estate

The Company has a strong intellectual property position on multiple anticancer candidates and continues to aggressively protect and expand its intellectual property estate. A key benefit of the IndUS acquisition is that Pivot now has a global drug development platform that combines the strengths of the United States, Canada and India, allowing for accelerated drug development strategies that result in a much faster time-to-market and greater capital-efficiency.

Corporate and Organizational Development

Pivot added significant strength and talent to its team in 2015. Following the acquisition of IndUS Pharmaceuticals, the Company retained the services of IndUS' CEO, Pravin Chaturvedi, PhD as its President & Chief Executive Officer. Dr. Chaturvedi has had a long and successful career in the pharmaceutical and biotech industry. For over 25 years, he has attained significant experience in drug development, as well as, founding and financing biotech start-up ventures. Dr. Chaturvedi joined the existing members of Pivot Pharmaceuticals' management team including Ahmad Doroudian, PhD, who serves as the Chairman of the Company and Moira Ong, who is Pivot's Chief Financial Officer. Collectively the Pivot team has developed and/or commercialized 12 drugs representing global sales in excess of $10 billion.

The Company also added two members to its Scientific Advisory Board (SAB). Steven Grossman, MD, PhD, joined Pivot Pharmaceuticals as the SAB's Chair. Dr. Grossman is a renowned physician-scientist with a long standing interest in basic and translational initiatives involving response of tumor cells to DNA damage to improve therapeutic benefit in cancer patients. Grannum Sant, MD, FRCS, FACS, is a distinguished key opinion leader (KOL) in the fields of urology and oncology in men's and women's health. Dr. Sant is an accomplished physician-scientist and has published widely in the fields of urology and cystitis

Pivot now has its drug development and operational base in Boston, a major hub of the biotechnology industry, which allows the Company access to the intellectual and financial resources available in the Greater Boston area.

Finance

In January 2016 Pivot's Executive Team attended the JP Morgan Health Care Conference in San Francisco. During the course of five days they met with several groups who expressed interest in financing Pivot's drug development programs. The Company is currently in discussions with interested parties.

2016 Goals and Objectives

Advance Anticancer Drugs into Clinical Trials:

Pivot will be significantly expanding its drug development efforts in 2016, allowing the Company to conduct additional pre-clinical studies and support the filing of an Investigational New Drug (IND) application with the regulatory authorities to initiate clinical trials in cancer patients. These clinical studies will evaluate the safety and clinical efficacy of one or both of Pivot's novel anticancer drug candidates (PVT-005 and PVT-006). To further complement the current executive, the Company expects to add new management team members accomplished in drug development, regulatory affairs, corporate licensing, program management, and marketing.

Expanding our Pipeline & Intellectual Property Estate:

To augment its anticancer pipeline, Pivot continues to opportunistically evaluate additional licensing opportunities for proprietary and patented molecules addressing unmet medical needs affecting women's health. Acquisition of a late-stage asset remains a top priority. Pivot will also continue to strengthen its intellectual property (IP) position through aggressive prosecution of patent applications.

Enhance shareholder communication:

It is important to educate the marketplace of the virtues of investing in Pivot Pharmaceuticals Inc. (OTCQB: PVOTF), as well as build a market for our stock to trade. We will continue to travel and connect with our investors and shareholders around the world to ensure more frequent communications, affording them a better understanding of our plans to build shareholder value. Pivot is represented by PCG Advisory Group which continues to refine our investor relations needs and better serve our shareholders.

Up-listing Application to Nasdaq

As the Company continues to execute its business strategy it is well positioned to up-list to the NASDAQ Stock Market, a move that will provide us increased visibility, greater access to capital, a broader investor base and ultimately help us implement our growth initiatives. The Company's objective is to meet the NASDAQ listing requirements. These requirements include meeting minimum thresholds for shareholder equity, the number of shareholders, market capitalization, and share price.
PIVOT: Poised for Success

The Company is confident that it has aggregated the requisite pieces that are required for sustainable long-term success and value creation. With a proven leadership team and a robust pipeline, Pivot will earn a significant share of the market with its novel treatments for unmet medical needs in women's cancers. Pivot's strong IP estate will allow for significant strategic partnering and licensing options. Biotech companies focused on novel drug development activities continue to represent a very high growth sector. For further information please read Pivot's Corporate Presentation and Executive Summary, available on its website.

About Pivot Pharmaceuticals, Inc.

Pivot is an emerging pharmaceutical company engaged in the development of novel therapies to address unmet medical needs in women's health including oncology and urology. The Company has a strategic emphasis on innovative drugs that will provide new treatment options for women's cancers as well as for unmet gynecological and urological problems. Pivot has a portfolio of novel anticancer candidates for the treatment of gynecological and breast cancers and it is also developing novel treatments to address disturbances such as lower urinary tract symptoms (LUTS). The Company has a global drug development platform that combines the strengths of the United States, Canada and India which allows accelerated drug development strategies to provide novel therapeutic options to address unmet medical needs in women's health.

Cautionary Statement

Except for historical information contained herein, the matters set forth above may be forward-looking statements that involve certain risks and uncertainties that could cause actual results to differ from those in the forward-looking statements. Words such as anticipate, believe, estimate, expect, intend, and similar expressions, as they relate to Pivot Pharmaceuticals or its management, identify forward-looking statements. Such forward-looking statements are based on the current beliefs of management, as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, such as the level of business and consumer spending, the amount of sales of Pivot's products, the competitive environment within the industry, the ability of Pivot to continue to expand its operations, the level of costs incurred in connection with Pivot's expansion efforts, economic conditions in the industry, and the financial strength of Pivot's customers and suppliers. Pivot does not undertake any obligation to update such forward-looking statements. Investors are also directed to consider all other risks and uncertainties.

Contact Information

  • Contact:

    PCG Advisory Group
    www.pcgadvisory.com
    Sean Leous
    Chief Communications Officer
    (646) 863-8998