REG - SkinBioTherapeutics - Regulatory Approval

SkinbiotherapeuticsAnnouncement

21/06/2023 07:00

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RNS Number : 3593D  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
(http://irs.nbtrader.co.uk/ir/SkinBiotix/newsArticle.php?id=31142822872670984&ST=SBTX)
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                                 Tel: +44 (0) 191 495 7325

 Stuart J. Ashman, CEO

 Manprit Randhawa, CFO
 Cenkos Securities Plc (Nominated Adviser & Broker)          Tel: +44 (0) 20 7397 8900

 Giles Balleny, Max Gould (Corporate Finance)

 Dale Bellis, Tamar Cranford-Smith (Sales)
 Instinctif Partners (financial press)                     Tel: +44 (0) 20 7457 2020

 Melanie Toyne-Sewell / Tim Field  / Adam Loudon         SkinBioT (mailto:SkinBio@instinctif.com) herapeutics @instinctif.com
                                                         (mailto:SkinBio@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 (http://www.skinbiotix.com)
and www.axisbiotix.com (http://www.axisbiotix.com) .

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