Positive Interim AxisBiotix Acne study results

SkinBioTherapeutics plc

("SkinBioTherapeutics" or "the Company")

Positive interim data from consumer participant study for Acne

27 ​February 2024 - SkinBioTherapeutics plc (AIM: SBTX), a life science company focused on skin health, announces that interim data from the AxisBiotix Acne food supplement consumer participant study with the lead formulation are very positive. The Company will continue the study to completion. The analysis and read-out of the final results is anticipated to occur before the end of Q1 2024.

The volunteer study, comprising 220 people, followed the same methodology to the AxisBiotix-Ps study, with the supplement containing the lead formulation, being supplied to participants in powder-form. Participants were then asked to record scores against specific criteria on an app. The scoring criteria included severity of acne, level of pain, attitude to appearance and levels of confidence.

The full study length is 56 days to reflect the time it takes for the skin to replenish itself completely. In people, the number of days ranges from 40-56 days, depending on age and location, therefore the maximum time was chosen for the study.

Interim study results

While results at this interim point are positive, there can be no certainty that these will either improve or be maintained.  The completion of the full study and analysis of the total data set is required to understand the outcomes.

The study is being conducted by an independent third-party, and the supplement blend has been formulated and manufactured by the Dutch food supplement provider Winclove Probiotics BV.

Stuart Ashman, CEO of SkinBioTherapeutics Plc, said:

"We are really excited to see such positive results against all the criteria at this interim stage. After the success of running a consumer participant study with the AxisBiotix-Ps product, we followed the same set-up for our acne candidate. And, just like the AxisBiotix study, many participants have recorded quite dramatic changes in their condition already. We have another three weeks to go, but if the final results reflect similar levels of effectiveness, we have the potential for a really important, new and effective option for people with acne of all ages."

Up to 85% of people will suffer from acne at some point in their life and sufferers tend to be keen to alleviate their symptoms. The global acne market is worth $9.4billion with CAGR of 4.8% (Fortune Business Insights 2019). In the UK alone, the market is worth c. £250m in 2022 and is projected to reach c.£300m in 2030, with c.34% of adults in the UK experiencing acne at some time in their lives. Acne is the most common skin condition and one of the top 10 most prevalent diseases worldwide.

Although not life-threatening, acne can cause irritation and life-long scarring, and can negatively impact a person's mental health and self-esteem. Acne 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.

Acne can range from mild to severe and typically affects teenagers and young adults but anyone can be affected. Treatment of severe acne often requires topical steroid creams which can lead to undesirable side effects, including skin dryness, irritation, and rashes. Alternative treatments include oral medications where side effects can be more severe e.g. depression or suicidal thoughts.

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

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.