PuriCore : Strategic Review and Trading Update

PuriCore plc

('PuriCore' or the 'Company')

A specialty biopharmaceutical company: developing novel immunomodulatory therapies

8 February 2016 -PuriCore plc(AIM: PURI), an international company focused on applying its proprietary hypochlorous acid platform technology to a range of unmet needs in human health, today confirms its new strategic focus and provides a trading update for the year ended 31 December 2015.

Highlights

New drug development focus confirmed after strategic review

· Follows comprehensive analysis of potential healthcare applications of proprietary hypochlorous acid platform technology

· Focus on the development of novel, prescription, topical treatments for inflammatory diseases

o To include Dermatology, Ophthalmology and potential orphan indications

o Pre-clinical study results suggest a differentiated mechanism of action

· First Investigational New Drug (IND) applications earmarked for Q1 2017

· Alex Martin, Chief Executive Officer, will present the Company's new strategy at the 18 Annual BIO CEO & Investor Conference in New York at 4:30 pm EST today

Strong revenue growth in FY2015

· Group revenue of $23.4 million, up 36.5% (2014: $17.1m), driven by Supermarket Retail revenue growth

· Year-end net cash of $15.5 million reflects continued disciplined investment (30 June 2015: $16.3m, 31 December 2014: $20.7m)

· Strategic options being evaluated for the Supermarket Retail business

Alex Martin, Chief Executive Officer of PuriCore, said:'I am very excited to leverage our hypochlorous acid based platform technology as immunomodulatory drug therapies, positioning PuriCore as an emerging specialty biopharmaceutical company. Following a comprehensive analysis of potential applications, we will initially focus on the development of novel, prescription topical treatments for inflammatory diseases, including potential orphan indications. I am confident that the Company is well positioned to embark on this journey as we have the expertise, strong IP, and a validated, de-risked technology for which there is already a significant body of clinical evidence in humans.'

Charles Spicer, Non-Executive Chairman of PuriCore, commented: 'The Board believes that the new focus on drug development should lead to the creation of significant shareholder value. Alongside this we are considering the strategic options available for our successful Supermarket Retail business. Whilst this business has delivered considerable top-line growth in 2015 and continued impressive market penetration, it addresses a very different market segment. As we demonstrated with the sale of our UK Endoscopy business in 2014, PuriCore has a track record of building differentiated, commercially attractive businesses that exploit our versatile platform technology.'

Drug Development Strategy

PuriCore currently serves the Supermarket Retail sector and Wound Care market with products that it has developed over several years. In 2014, the Company sold its successful UK Endoscopy business, whose original product development had been based on hypochlorous acid, to Cantel Medical, a leading provider of infection prevention and control products and services in the healthcare market. Following that sale, the Board embarked upon a strategic and operational review focused on how best to further leverage the Company's technology and drive shareholder value. This review has been led by the Company's recently-appointed CEO, Alex Martin.

The conclusion of the strategic review has been to initiate a drug development program based on PuriCore's patented hypochlorous acid technology and formulations at high concentration. During the review, the Company generated compelling evidence in preclinical studies that these formulations have novel immunomodulatory activity with potential application for the treatment of diseases in a number of therapeutic areas such as Dermatology and Ophthalmology, including certain orphan indications. In relevant animal models of disease, for instance, application of the formulations resulted in a statistically significant impact on allergen-induced itch and inflammation associated with atopic dermatitis (including evidence of the inhibition of key cytokines), as well as hyperemia (red eye) associated with allergic conjunctivitis. This work builds upon previous clinical experience with the Company's medical devices in Wound Care and Dermatology.

In parallel to the preclinical work, the Company worked with a leading pharmaceutical consulting firm to complete a comprehensive drug development strategic review. This review, involving influential key opinion leaders (KOLs), focused on unmet medical needs with considerable commercial value and resulted in the development of a product pipeline in several therapeutic areas based on formulations containing the Company's proprietary immunomodulatory technology. In 2016, the Company is continuing formulation development and conducting a series of additional preclinical and toxicology studies in support of the planned Investigational New Drug (IND) filings.

It is expected that, if successful, clinical development and subsequent New Drug Application (NDA) filing(s) with the FDA will lead to novel prescription medicines for commercially attractive and underserved markets. On current timelines, the Company expects to file two IND applications with the FDA in Q1 2017 and commence clinical testing thereafter. The Company has a search underway for a Chief Medical Officer to support these goals.

Supermarket Retail Update

In light of the compelling opportunities to potentially generate significant shareholder value through the drug development strategy, and the associated planned investments,the Board is considering strategic options for the Supermarket Retail business, which has delivered strong sales growth and market penetration. Options may include spinning out the business into a stand-alone and potentially separately funded entity, selling the business, establishing a joint venture with a strategic partner and/or other arrangements that could further drive growth in this market-leading business by leveraging it through a more extensive and complementary company infrastructure. The Board has engaged advisors to assist in evaluating these alternatives.

As previously mentioned in the 2015 Interim Results, the US Environmental Protection Agency (EPA) has been reviewing the Company's concentrate products as part of an ongoing investigation. The Company has been asked to provide additional information related to previous sales and promotion of these products, and is fully cooperating with the EPA. The Company will continue to update the market as appropriate.

Trading Update

The Company also provides a trading update for the year ended 31 December 2015. Group revenue for the period was $23.4 million, representing growth of 36.5% compared to the prior year (2014: $17.1m). This increase is underpinned by Supermarket Retail revenue growth in both the concentrate and capital equipment product lines. Net cash was $15.5 million as at 31 December 2015 (31 December 2014: $20.7m). The Company expects to report full year results by the end of March 2016.

Enquiries:

About PuriCore

PuriCore is an emerging specialty biopharmaceutical company focused on developing novel immunomodulatory therapies, based on its proprietary hypochlorous acid platform technology. The Company has initiated a drug development program based upon its proprietary technology and formulations at high concentrations. The Company believes their formulations have novel immunomodulatory activity with potential application for the treatment of diseases in a number of therapeutic areas such as Dermatology and Ophthalmology, including potential orphan indications. Currently, the Company serves the Supermarket Retail sector and Wound Care market (as a medical device) utilizing different formulations. For more information, visitPuricore.com.

Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions shareholders and prospective shareholders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

PuriCore plc issued this content on 08 February 2016 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 08 February 2016 07:08:15 UTC

Original Document: http://investor.puricore.com/phoenix.zhtml?c=201403&p=irol-rnsArticle&ID=2136270