RLM.L Regulatory News (RLM)

PuriCore plc

("PuriCore" or the "Company")

PuriCore expects to initiate two Phase II clinical trials in 2017

PuriCore to rename as Realm Therapeutics

Positive feedback from FDA sets clear path for Allergic Conjunctivitis programme; new data presented today enhances Atopic Dermatitis rationale

16 November 2016 - PuriCore plc (AIM: PURI), an emerging specialty biopharmaceutical company focused on leveraging its proprietary immunomodulatory technology, is pleased to provide the following updates on its key development programmes, both of which leverage the Company's patented hypochlorous acid formulations.

PR013, being developed for the treatment of Allergic Conjunctivitis*:

· The Company successfully completed a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) on PR013, which validated plans to enter a Phase II trial following submission of the IND.

· The Company plans to submit the IND application for PR013 in Q3 2017 and to initiate the clinical trial in 2017.

· PR013 is a proprietary topical ophthalmic solution containing high concentrations of hypochlorous acid as the active moiety.

· The Company has demonstrated that PR013 is associated with a statistically significant therapeutic effect in established animal models of Allergic Conjunctivitis.

PR022, being developed for Atopic Dermatitis**:

· Pre-clinical data on PR022 for Atopic Dermatitis, noting significant reduction of key cytokines associated with the disease, including IL4, IL13, IL-31 and TARC, and serum IgE, is being presented today at the Inflammatory Skin Disease Summit in New York City.

· Following the successful pre-IND meeting with the FDA in June, the Company's plans remain to submit an IND application for PR022 in Q1 2017 and to begin a Phase II trial shortly thereafter.

· PR022 is a proprietary topical gel also containing hypochlorous acid as the active moiety.

· The Company has demonstrated that PR022 is associated with a statistically significant therapeutic effect in established animal models of Atopic Dermatitis.

* Allergic Conjunctivitis, or ocular allergy, is an immune-mediated disease characterized by itching, redness, burning, and tearing of the eye which affects at least 20% of the population globally.

** Atopic Dermatitis (AD) is a chronic inflammatory skin disease which poses a significant burden on patients' quality of life and on the overall health care system. AD affects up to 20% of children and up to 3% of adults and prevalence numbers continue to increase.

As at 31 October 2016, cash and cash equivalents were $23.7 million (30 June 2016: $12.8 m), reflecting receipt of the gross proceeds from the sale of the Supermarket Retail business, less certain deal-related costs. Investments are expected to accelerate in 2017 as two IND applications are filed and clinical trials begin and as the remaining deal costs are paid.

In addition, the Company today announces its intention to change its name to Realm Therapeutics to more accurately reflect the Company's strategic focus and direction. The change is expected to be effective by year-end and a further announcement will be made at the appropriate time.

Alex Martin, Chief Executive Officer of PuriCore, said: 

"The completed disposal of the Supermarket Retail business has generated additional funds to progress our two lead candidates into clinical trials. The intended change of the Company's name to Realm Therapeutics signifies our sole focus on drug development as an emerging specialty biopharmaceutical company.

"We are extremely pleased with our continued progress and are excited to share further developments related to our two candidates, PR013 and PR022, including the timelines for submission of the two INDs, and initiation of two Phase II clinical trials in 2017. We look forward to providing further updates in due course."

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About PuriCore

PuriCore is an emerging specialty biopharmaceutical company focused on developing novel immunomodulatory therapies to protect and improve the lives of adults and children. The Company has initiated drug development programmes, based on its proprietary hypochlorous acid technology 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 including Dermatology and Ophthalmology.

Forward looking statements

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.