Skinbiotherap. Regulatory News (SBTX)

SkinBioTherapeutics plc

SkinBiotix® platform passes external cytotoxicity tests

Scientific progress on track

Manchester, UK - 3 October 2017 - SkinBioTherapeutics plc (AIM: SBTX, the "Company"), a life science company focused on skin health, has passed third party cellular toxicity tests for its SkinBiotix® technology, confirming previous in-house observations on its safety and applicability.

The Company has also been progressing its three programmes and is on track to hit its key milestone of first studies in man in 2018.

Cytotoxicity studies

The studies were conducted by Charles River, a Contract Research Organisation, in accordance with the OECD Principles of Good Laboratory Practice.

The objective of the toxicity tests was to determine if there were any adverse biological reactions from mammalian cell cultures following the use of SkinBioTherapeutics' SkinBiotix® technology.

Following incubation for 24 hours, no cytotoxicity was observed e.g., malformation of cells or cell degeneration. The data confirm SkinBioTherapeutics' in-house observations on how mammalian skin cells and fibroblasts respond to being exposed to SkinBiotix®. This further supports the principle of SkinBiotix®'s suitability for use in skin care applications.

Two further tests, phototoxicity and in vitro ocular toxicity are scheduled. These results will be reported when the data is received.

Scientific update

As outlined at IPO in April 2017, SkinBioTherapeutics has been concentrating on further developing its technology towards the three applications in skin care, anti-infection and skin repair.

The positive cytotoxicity result above is a key milestone. However, other work is progressing well and the Company has summarised this below:

- Manufacture: work on scale-up has been initiated, confirmed by the successful manufacture of SkinBiotix® by an external partner

- Pilot scale formulation has been initiated by an external partner with expertise in cosmetic formulation development. Phase one of three is complete; testing of solubility and preservative requirements of the technology. Phase two, identifying a final blend for testing, is currently underway

- Early stage commercial discussions are ongoing with both potential manufacturing partners as well as potential licensees

- Anti-infection and eczema programmes

o A 'time-course' study, has confirmed that the frequency of application required for protection is three times daily. Therefore, protection against Staphylococcus aureus infection for both eczema and infection programmes requires application every five hours*

- Regulatory process has commenced and a regulatory consultant has been appointed 

- Ongoing scientific studies:

o Defining dosage is complete - for all three applications. SkinBioTherapeutics has finalised a dosing level at which the technology will be used which maintains the viability of the skin cells

o Confirmation of the modifying property of SkinBiotix® on protein composition of the skin, increasing the expression of Claudin 4, an essential component in tight junctions which are critical for the barrier characteristic of skin

\* These data were recently presented at a Wellcome Trust conference: "Host Microbiome Interactions in Health and Disease".

Dr Catherine O'Neill, CEO of SkinBioTherapeutics, commented:

"This announcement demonstrates the excellent progress SkinBioTherapeutics is making at all levels - scientific, development, manufacture and commercial.

"The result from the cytotoxicity testing by Charles River is essential external validation of our SkinBiotix® platform. This was one of the key milestones to pass and was highlighted as such at the IPO. Its passing marks a critical step in our progression and the transitioning of the technology into human validation studies.

"Operationally, we are on track. The development programmes are progressing well, we are generating further scientific data on SkinBiotix® confirming its suitability for application to skin, and industry awareness of our technology is growing."

This announcement contains inside information for the purposes of Article 7 of EU Regulation 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 CEO Dr. Catherine O'Neill and Professor Andrew McBain.

SkinBioTherapeutics' platform applies research discoveries made on the activities of lysates derived from probiotic bacteria when applied to the skin. The Company has shown that the SkinBiotix® platform can improve the barrier effect of skin models, protect skin models from infection and repair skin models. Proof of principle studies have shown that the SkinBiotix® platform has beneficial attributes applicable to each of these areas.

SkinBioTherapeutics received seed funding from the Tech Transfer office of the University of Manchester for the discovery of SkinBiotix®. The platform was subsequently spun out of the University of Manchester in March 2016 and was funded by OptiBiotix (AIM: OPTI).

The Company joined AIM in April 2017 concurrent with raising £4.5 million from a placing of new ordinary shares.

The Company is based in Manchester, UK. For more information, visit www.skinbiotherapeutics.com.

About Charles River

Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Its dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about Charles Rivers' unique portfolio and breadth of services, visit www.criver.com.