Skinbiotherap. Regulatory News (SBTX)

19 August 2021

SkinBioTherapeutics plc

("SkinBioTherapeutics" or "the Company")

Business Update

· AxisBiotix-Ps™ now regulatory compliant in the US, UK and EU;

· Commercial launch of AxisBiotix-Ps™ remains on track for Q4 2021;

· Further analysis of the AxisBiotix data set shows some encouraging potential for other skin conditions including eczema, acne and rosacea;

· SkinBiotix manufacturing scale-up with Croda progressing to schedule;

· Cash at 30 June 2021 £4.6m (31 December 2020 £5.5m)

SkinBioTherapeutics plc (AIM: SBTX), a life science company focused on skin health, has today provided a business update including an update on plans for commercialisation of AxisBiotix-Ps™ as committed to in the announcement of 26 May 2021. In summary, operationally, the Company has made significant progress with its plans to launch AxisBiotix-Ps™ in Q4 2021 and scale-up SkinBiotix to commercial volumes. Financially, the Company ended the 12 months to 30 June 2021 with a solid cash balance of £4.6m (31 December 2020: £5.5m).

AxisBiotix-Ps™

Study results

In May 2021 the Company reported on the outcomes of the study for participants that self-identified as suffering from psoriasis. For the full report, please visit the AxisBiotix website www.axisbiotix.com. The results were very positive and provided definitive support for the commercial development of AxisBiotix-Ps™ which will be launched in Q4 2021 as a probiotic food supplement to help alleviate the symptoms of psoriasis.

Even though the study was originally designed for participants who self-identified with psoriasis, people with other skin conditions e.g. acne, eczema and rosacea also joined the study. The number of non-psoriatic participants was relatively small, but analysis of the data set from those who completed the study at day 56 was very promising.

· Psoriasis + Participants in the study who self-identified as suffering from psoriasis and at least one other skin condition. Of these, 80% reported a reduction in itchiness and 85% reported that their skin felt less irritable.

· Eczema

Participants who self-identified as suffering only from eczema reported the following results:

· 71% reported that their skin felt less itchy;

· 71% reported that their skin felt less irritable;

· 64% reported a reduction in redness; and

· 64% a reduction in 'flaky patches' on their skin.

· Acne and rosacea

The small group of participants who self-identified with these conditions reported improvements to their skin conditions. Due to the size of the group, a larger cohort would be needed before statistics are published.

These early indicative study results with other participants are very interesting and support the Company's aim to expand the AxisBiotix pipeline beyond psoriasis into other targeted skin conditions. The development of new AxisBiotix products would require the addition of condition-specific probiotic strains to the core strain, which would then be tested through similar participant studies to the most recent psoriasis study.

Commercialisation on track for Q4 2021

The Company has been preparing for the commercial launch of AxisBiotix-Ps™ since the completion of the study and has made excellent progress. To date, the team has been finalising the regulatory pathway and commercial strategy, preparing the marketing campaigns and establishing a reliable and robust supply chain.

The AxisBiotix-Ps™ product is regulatory compliant in the US, the UK and Europe.

The commercial strategy is to target the US and UK markets initially, with the EU following very shortly after. Excluding shipping and any duty costs, the product will be marketed on a subscription basis and priced per sachet in the US at $2.00 (USD), in the UK £1.50 (GBP), and in Europe €1.80 (EUR) and sold in boxes containing 28 sachets.

To create a ready-made market for the product at launch, the Company is conducting a multi-media marketing strategy to encourage further pre-registration of interest from potential customers. Upon launch, the product will then be released on a controlled basis to both test the supply chain and ensure continuity of supply for subscribers.

Croda - progressing well to create a bioactive for cosmetics skincare

Croda and its active ingredient arm Sederma, continue to progress the development of SkinBiotix® as the foundation for an active skincare ingredient. The project is progressing through the increasing levels of manufacturing scale-up which is now at 600 litres and will then move to 20,000 cubic metres (final step for the worldwide market) in September 2021 and in line with the agreed project plan.

Stuart Ashman, CEO of SkinBioTherapeutics, said:

"We are very pleased with the progress the Company has been able to make over the first half of this year, both with AxisBiotix-Ps™ and SkinBiotix (Croda).

"AxisBiotix-Ps™ is now regulatory compliant in the UK, US and EU and our focus is to continue building a robust supply chain and drive forward the commercialisation process in order to launch the product, on a controlled basis, in Q4 of this year as planned.

"We are also taking a keen interest in the results from participants self-identifying as suffering from eczema, acne or rosacea. These initial study results give us the confidence to undertake additional studies and commence the development of additional potential products targeted at assisting in alleviating skin conditions such as these."

-Ends-

The information communicated within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 and has been arranged for release by Doug Quinn, CFO of the Company. Upon the publication of this announcement, this inside information is now considered to be in the public domain.

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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 Prof. Catherine O'Neill and Professor Andrew McBain.

The Company has demonstrated, through scientific testing, that the SkinBiotix® platform can improve the barrier effect of skin models, protect from infection and repair wounds. Proof of principle studies have also shown that the SkinBiotix® platform has beneficial attributes applicable to each of these areas. The technology achieved positive results in clinical studies in human volunteers in early 2019.

The Company listed on AIM in April 2017 and is based in Manchester, UK. For more information, visit: www.skinbiotix.com.