Regulatory Approval

SkinBioTherapeutics PLC

21 June 2023

 

 SkinBioTherapeutics plc

("SkinBioTherapeutics" or "the Company")

AxisBiotix-Ps™ receives health authority approval for launch in Italy

·    Second European market to receive approval after Spain earlier in 2023; marketing to customers to start in July 2023.

·    Next target market for launch is France, anticipated in H2 2023

·    Broader launch presents further validation of the benefits of this product and opens new geographical revenue streams

21 June 2023 - SkinBioTherapeutics plc (AIM: SBTX), a life science business focused on skin health, has announced that it has received approval from regulators to issue AxisBiotix-Ps™, a food supplement to alleviate the symptoms associated with Psoriasis, into the Italian market.

The announcement follows the launch of AxisBiotix-Ps™ in Spain, after prior authorisation was received in March. Building on the initial launch in the UK where customer retention rates have remained above 80%,¹ the launch of AxisBiotix-Ps into another European market is the continuation in the commercialisation strategy.

Between 2-3% of Italians report being affected by Psoriasis, in keeping with the global prevalence rate and similar to the rates reported in Spain and the UK, where AxisBiotix-Ps™ is currently available. The fact that over half of Italians use food supplements to improve their overall health and wellbeing gives the Company confidence that the introduction of the product to the Italian market will be met with positively.

The next target country for launch is France. Talks with French regulators are currently underway and commercialisation is anticipated in H2 2023.

Stuart J. Ashman, CEO of SkinBioTherapeutics, said: "In line with our strategic plan, we are delighted that AxisBiotix-Ps™ is now approved for sale into another European market, after the initial success in the UK and then Spain. We have seen high customer retention rates and we anticipate that Italian consumers will follow this trend due to their positive attitude to food supplements. We are now awaiting the decision from the regulatory authorities in France, which is on track for later in 2023."

Psoriasis is a lifelong condition, with no known cure, which impacts the everyday lives of sufferers. Existing treatments such as steroids or immuno-suppressants cannot be used over the long-term, which makes AxisBiotix-Ps™ an effective solution to alleviate its symptoms. As a food supplement, AxisBiotix-Ps™ is based on strong scientific data regarding the gut-skin axis, re-introducing missing bacteria into the gut and redressing the balance to improve skin health.

1: As reported in the Full Year results dated 15 December 2022

-Ends-

The information communicated in this announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No. 596/2014.

For more information please contact:

SkinBioTherapeutics plc Stuart J. Ashman, CEO Manprit Randhawa, CFO	Tel: [phone]
Cenkos Securities Plc (Nominated Adviser & Broker) Giles Balleny, Max Gould (Corporate Finance) Dale Bellis, Tamar Cranford-Smith (Sales)	Tel: [phone]
Instinctif Partners (financial press) Melanie Toyne-Sewell / Tim Field  / Adam Loudon	Tel: [phone] SkinBioTherapeutics @instinctif.com

Notes to Editors

About SkinBioTherapeutics plc

SkinBioTherapeutics is a life science company focused on skin health. The Company's proprietary platform technology, SkinBiotix®, is based upon discoveries made by Professor Catherine O'Neill and Professor Andrew McBain.

The Company is targeting a number of skin healthcare sectors, the most advanced of which are cosmetic skincare and food supplements to modulate the immune system by harnessing the gut-skin axis. In each area SkinBioTherapeutics plans to exemplify its technology through human studies. The Company's first product, AxisBiotix-Ps™, a food supplement to address the symptoms of mild to moderate psoriasis.

The Company listed on AIM in April 2017 and is based in Newcastle, UK.

For more information, visit: www.skinbiotix.com and www.axisbiotix.com.

 

END