Skinbiotherap. Regulatory News (SBTX)

 SkinBioTherapeutics plc

("SkinBioTherapeutics" or "the Company")

SkinBiotix™ and AxisBiotix™ update

· Positive update from Sederma (Croda) team on progress of its work with SkinBiotix™

· Plans by Sederma to undertake further studies to confirm identified additional properties of SkinBiotix™ to enhance the commercial opportunity

· AxisBiotix-Ps™ sales have commenced in Spain aided by launch of regional website; Italy and France to be next territories for launches

10 May 2023 - SkinBioTherapeutics plc (AIM: SBTX, or the Company), a life science business focused on skin health, has received an update of progress from its partner, Sederma, a division of Croda International Plc ("Croda"), which includes plans to undertake additional studies on SkinBiotix™ which are expected to enhance the commercial opportunity.

Croda update

In November 2019, SkinBioTherapeutics signed a commercial agreement with Croda, the company responsible for the high performance ingredients and technologies in some of the world's largest and most successful brands. Under the terms of the agreement, Sederma, Croda's cosmetics division, is responsible for the development, manufacturing and commercialisation of the SkinBiotix™ technology.

As design and build of the facility for the production of the active ingredient has progressed, Sederma has conducted concurrent investigations in focussed application areas. As a result of these investigations, the Sederma team is now seeking to undertake additional formal studies to investigate potential added benefits of the SkinBiotix™ technology.

The further studies are expected to take an additional three to four months, and would run from November 2023 through to Q1 2024. Any additional benefits identified from these studies would enable Croda/Sederma to add to the commercial opportunity for SkinBiotix as an active ingredient and could lead to enhanced claims and therefore a higher price point in market. The costs of these additional studies will be paid for by Sederma.

Any licensed products resulting from the agreement with SkinBioTherapeutics will be sold to Croda's global portfolio of Personal Care customers. SkinBioTherapeutics will be paid tiered royalties based on global sales revenues on any licensed products derived from the partnership.

Dr Damian Kelly, Vice President Innovation & Technology Development at Croda Europe Ltd, responsible for the project said:

"This [SkinBiotix™ programme] continues to be a fascinating project that is heading towards commercialisation and will break new scientific ground in the use of lysated bacteria in the cosmetic industry as a skin care active ingredient." 

Dr Kelly added, "We have recently observed some additional unexpected technical benefits during our projected scale-up activities which, if shown to be efficacious through further in-vitro and in-vivo clinical trials, would then offer significant supplementary applications and greater product valorisation as a skin care cosmetic active. We are excited by the findings we have seen thus far and look forward to a long and prosperous relationship with SkinBioTherapeutics."

AxisBiotix-Ps™ European expansion update

As previously announced, sales have started in Spain accompanied by the launch of a Spanish-language website (see link) with distribution of product taking place from the Company's EU hub in the Netherlands. Sales are being managed by the UK AxisBiotix team. Preparations are underway to launch in Italy, followed by France later in the year. Each country requires approval from the respective healthcare regulators; talks are progressing well in both locations.

Acquisitions

Management continues to negotiate terms with the potential vendors of the previously announced acquisition target. In addition, the Company continues to explore potential acquisition opportunities although it is clear that any transaction must be truly accretive as well as sector relevant and scientifically focused before it is considered.

Stuart J. Ashman, CEO of SkinBioTherapeutics, said:

"We remain pleased with the progress of our partnership with Croda even though we have not been able to say much about the work underway for commercial sensitivity reasons and we are encouraged by the reaction from the Sederma team. We also share their belief that there may be additional properties which could enhance the sales opportunity of SkinBiotix.

"As previously announced, we have also commenced sales of AxisBiotix-Ps in Spain in order to help people suffering from the symptoms of psoriasis. Receiving approval from the Spanish health authorities to proceed, the launch of our Spanish commercial site and early positive responses from potential customers provides additional validation of our product."

-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.

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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.