Skinbiotherap. Regulatory News (SBTX)

SkinBioTherapeutics plc

("SkinBioTherapeutics" or "the Company")

SkinBioTherapeutics to commence new consumer study into acne

Trading update for Full Year 2023

Change of Auditor

Acne Study:

· Two new formulas to be trialled to compare efficacy against the most common skin condition

· To take place in the UK, involving 300 participants who have acne-prone skin

· Study to be conducted in partnership with Winclove Probiotics

· Completion of study expected by the end 2023, with results in Q1 2024

Trading Update for Full Year June 2023:

· Trading and cash for the full year to June 2023 in line with expectations

· Full year results will be announced at the end of November

· Change to Company's auditors due to auditors' corporate reorganisation

25 October 2023 - SkinBioTherapeutics plc (AIM: SBTX, or the "Company"), the life science business focused on skin health, announces that the Company is commencing a consumer study into a novel acne formula. Furthermore, the Company announces an update on trading for the full year to June 2023 and an update on the Company's auditors.

Acne consumer study

Two separate blends, specifically formulated by Dutch food supplement provider Winclove Probiotics BV, will be tested side-by-side in a consumer volunteer study to determine which has better efficacy. The Company aims to target the inflammatory pathways that are associated with irritable skin conditions like acne. The blends will be supplied to participants in powder-form for the study, however this may not be the final formulation form for a potential commercial product.

The study will involve 300 UK-based participants with acne-prone skin, who will be recruited online via a pre-qualification questionnaire form. 150 randomly selected participants will receive product 1, the other half of the group will receive product 2.

The products will be mailed to participants who are expected to record their experience of using the product in a weekly questionnaire over eight weeks, over which they are expected to take the product daily. A follow-up questionnaire will be provided one month after the participants stop taking their allocated product.

The benefit of undertaking a consumer study is the relatively short time and cost compared to a clinical study. The study is expected to be completed by the end of 2023 with results reported in Q1 2024.

Stuart Ashman, CEO of SkinBioTherapeutics, said:

"This study is potentially a major step towards the commercialisation of a new probiotic treatment that could address the root causes of conditions like acne. Acne, and related irritable and inflammatory conditions are not just skin deep - there is considerable evidence to suggest that it is caused by an imbalance in the gut-skin axis, where the absence of certain strains of bacteria and the over presence of others can stimulate excessive sebum production. Our probiotic formulation aims to correct this imbalance in the same manner as our psoriasis product - AxisBiotix-PsTM."

Acne is a skin condition that develops when pores get clogged with dead skin, bacteria, and dried skin oil buildup, which leads to redness, tenderness, pimples, nodules, or cysts primarily on the face, back, or chest. Up to 85% of people will suffer from acne at some point in their life. Although not life-threatening, acne can cause irritation and life-long scarring, and can negatively impact a person's mental health and self-esteem.

The strong desire to alleviate the symptoms makes the global acne market worth US$10.5 billion in 2022 with CAGR of 5.1% [Source: Fortune Business Insights 2023]. The UK acne therapeutics market size is at around $261m in 2022 and is projected to reach $377m in 2030, exhibiting a CAGR of 4.7%. 34% of adults in the UK have experienced acne at some time in their lives and 11.5% of adults presently have acne [Source: Insights10]. Overall, this means that acne is the most common skin condition and one of the top 10 most prevalent diseases worldwide.

Trading update for FY23

Trading for the full year to June 2023 was in line with market expectations. Cash at year end was £1.3m, ahead of expectations of £1.1m, and the Company continues to control its costs. The Company will update shareholders when the full year results are published in November 2023.

Since the year end, the Company has continued to roll out AxisBiotix-Ps with approval in France and Italy to add to the previously announced launch in Spain. The Company also continues to progress the development of the Acne product with launch of a consumer study.

As previously noted, the Company's partner, Croda is looking to undertake additional studies on SkinBiotix? based on the discovery of significant additional bacterial activity. The studies are expected to commence in Q4 2023 with results in Q1 2024.

The Company continues to actively monitor potential accretive M&A targets and has been encouraged by its initial engagement with a number of potential targets. The Board hopes to be able to complete at least one accretive transformational acquisition in the near term.

Update on the Company's auditors

Following a business reorganisation, Jeffreys Henry LLP has indicated that it will resign as the Company's Auditor as the firm will provide audit services to clients from another company in the group, Gravita Audit Limited. Gravita Audit Limited has been appointed as the Company's auditor for the financial year ending 30 June 2023. This was announced in the Company's FY22 Annual Report.

Jeffreys Henry LLP has confirmed to the Company that, in accordance with Section 519 of the Companies Act 2006, there are no circumstances in connection with its resignation which it considers need to be brought to the attention of the Company's members or creditors.

-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.skinbiotherapeutics.com and www.axisbiotix.com.