Skinbiotherap. Regulatory News (SBTX)

4 December 2020

SkinBioTherapeutics plc

("SkinBioTherapeutics" or "the Company")

Full year results

SkinBioTherapeutics plc (AIM: SBTX), a life science company focused on skin health, announces its full year audited results for the year to 30 June 2020.

Key highlights

· First commercial deals signed across two technology channels - skin care and food supplement

· Finalised formulation for food supplement to target psoriasis ready for human study and potential commercialisation

· Active skin care ingredient development on track with partner, Croda plc, with commercialisation expected in 2022

· Cash as at 30 June 2020 of £2.2m (2019: £3.1m)

· Post year end: successful placing and open offer raising £4.45m

Stuart Ashman, CEO of SkinBioTherapeutics, said:

"This has been a year of considerable progress for SkinBioTherapeutics. At the beginning of the financial year, we identified and established the five strategic channels that we were going to advance, pivoting from a research focus into a commercial focus. We have been able to make considerable headway during the year, despite the COVID-19 pandemic.

"Our first two commercial deals with Croda and Winclove have hit important milestones either on or ahead of schedule. Our Croda partnership in skincare is going well and the food supplement formulation has been finalised and is ready for a human study, which we are aiming to commence in early 2021. With our post year end placing along with robust cash controls, we are well placed to advance in a number of areas over the coming year."

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.

-Ends-

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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 Professor 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.skinbiotherapeutics.com.  

Chairman's Statement

2020 has been another exciting year for SkinBioTherapeutics with significant progress in a number of key areas of the Company's commercial and development strategies. The Company has signed its first two commercial deals, accelerated the project timeline for its food supplement programme and gained commercial interest for its MediBiotix™ and CleanBiotix™ programmes. Given these achievements have been made in a time of pandemic which has presented numerous challenges, the team has impressed with its swift action, flexibility and resource to keep the development and commercial programmes on track.

The Company's strategy was reviewed at the beginning of the financial year, and culminated with a shift from an R&D focus to a more commercial one. The management team has identified five channels across which the Company is seeking to harness the microbiome for human health.

The first step of delivery against this strategy was achieved in November 2019 with a commercial agreement with Croda International Plc ("Croda"). The agreement is for the development and commercialisation of a new active skincare cosmetic ingredient incorporating the Company's SkinBiotix® technology.

The scientific team, under the stewardship of Professor Cath O'Neill, who transitioned to the role of CSO in July 2019, has been exploring the relationship between the gut and the skin. There is strong scientific evidence pointing to a link between gut dysfunction, stress-induced alterations to the gut microbiome and skin inflammation. This research culminated in a development agreement with Winclove Probiotics B.V. ("Winclove") for the development of a probiotic blend of 'good' bacteria strains to help manage the symptoms associated with the skin condition psoriasis. Since the announcement of this programme, the Company has received substantial interest from both healthcare and patient communities. Progress on both these key strands of technology has been significant during the course of the year.

With the food supplement for psoriasis, Winclove confirmed, several months ahead of schedule, that it had been able to successfully combine and formulate the proprietary blend of 'good' bacterial strains as a food supplement, to be known as AxisBiotix™Ps. This is another important milestone since this blend will form the central pillar of the supplement to be used in a food supplement study ahead of eventual commercialisation.

For the cosmetic application, Sederma, the French division of Croda that specialises in the manufacture of bioactive ingredients for the cosmetic industry, updated the Company in July 2020 that despite COVID-19 it remains on track with the original project timeline. It has also been able to replicate the Company's lysate manufacturing process, which is a critical milestone for the project, and means Sederma can now press ahead with scaling up the manufacturing process at different volume levels as it prepares for future commercial launch.

The SkinBioTherapeutics project team has been quick to respond to the constraints of COVID-19 that are currently limiting human studies in a clinical environment and as detailed in the operational review section, the team is pressing ahead with preparations for a 'self-managed' food supplement study. The project team deserves enormous credit for its ability to pivot so quickly in challenging circumstances and identifying a solution that will shorten the timeframe to commercialisation.

The Company continues to manage its cash and resources well and ended the year with a cash balance of £2.2m (2019: £3.1m). Post year end, in November 2020, the Company completed a placing to new and existing institutional shareholders raising a total of £4.45m. The funding enables the Company to expand its technology pipeline with further work in areas such as hair and oral care and UV protection, and to support the transition from a virtual operation to one with an in-house scientific capability. The funding, aligned with the scientific and operational progress of the last 12 months, leaves the Company ideally positioned to push forward with its strategy which offers exciting potential over the course of the next 24 months.

On behalf of the Board, I would like to take the opportunity to thank Stuart, Cath and the rest of the team, together with the teams at Winclove and Croda for the substantial progress achieved in the current climate.

Martin Hunt

Chairman

Chief Executive's Statement

Overview

SkinBioTherapeutics is a life sciences business focused on harnessing the microbiome, the bacteria that live on and in our bodies, for human health.

SkinBioTherapeutics' proprietary technology, SkinBiotix®, is designed to promote skin health by harnessing the beneficial properties of probiotic bacteria and the active components derived from them. The approach taken is to use a 'lysate' of probiotic bacteria cells as a topical agent. The use of a lysate rather than live bacteria circumvents the possible safety considerations associated with applying live bacteria to the skin and the potential formulation difficulties of keeping bacteria alive in a cream.

An emerging area of science is focused on the gut-skin axis and how the constitution of the gut plays a role in various diseases, such as psoriasis. SkinBioTherapeutics has been exploring the relationship between the gut and the skin, and the potential to introduce probiotic bacteria to the gut and effect a direct improvement to psoriasis-sufferers' skin.

The Company is pursuing a strategy that addresses five channels as its area of focus, encompassing both new and existing technology. Each channel offers the potential for multiple applications or sub-channels.

· SkinBiotix®

This is the Company's core technology and in November 2019 an agreement was signed with Croda Plc, a FTSE 100 company. Croda is a world leader in the field of active skincare ingredients for the cosmetic industry and sells ingredients for skin and hair care products to major cosmetic brands across the world.

Under the terms of the agreement, SkinBioTherapeutics' proprietary SkinBiotix® platform will be paired with Croda's expertise in the development and commercialisation of unique and sustainable, cosmetic ingredients, focusing specifically on the growing skincare actives market. Sederma, part of Croda, is a specialist manufacturer of bioactive ingredients for the cosmetic industry, and will be responsible for the development, manufacturing and commercialisation of the SkinBiotix® technology. Croda will be creating a separate manufacturing line for the technology and as design and manufacture of the active ingredient is carried out, there will be concurrent testing in focused ingredient application areas which will be detailed in further, additional agreements.

Any licensed products resulting from these agreements will be sold to Croda's global portfolio of Personal Care customers, which amount to >12,000 companies and/or brands, some of which are leaders in their respective markets. SkinBioTherapeutics will be paid tiered royalties based on global sales revenues on any licensed products subsequently derived from the successful development of the partnership.

In July 2020 Sederma updated the Company on the progress of key milestones in the collaboration: 

· Successful replication of the lysate manufacturing process and achievement of the same performance from the SkinBiotix® technology as had been achieved by the Company - an essential first step in the process of formulation; and

· Commencement of activities to validate scale up of the manufacturing process at different volume levels - an essential step in order to achieve commercial quantities.

The project is progressing in line with the original plan and has not been adversely impacted by COVID-19. On the basis of continued progress, the Company anticipates licensed royalty revenue generation to commence in 2022.

Sales and distribution rights are for the cosmetic sector alone, leaving SkinBioTherapeutics to focus on further applications of its technology in other sectors. A key component of the Croda agreement is to provide access to a reliable supply of material to SkinBioTherapeutics. Croda will supply SkinBiotix® for the Company to be able to use in other sectors outside of those covered by this agreement.

· AxisBiotix

Research focused on the gut-skin axis has found that one disease that may be directly influenced is psoriasis. This is a chronic relapsing inflammatory condition of the skin with a prevalence of c.2-3% in the western world. The worldwide market for psoriasis treatments was valued at approximately $30bn in 2018 and is expected to grow to $47bn in 2022 with a CAGR of 11.5%.

Current treatments include moisturising treatments or emollients to soothe and hydrate the skin for relatively mild disease, through to the biologic therapies in severe cases. For the group with mild-to-moderate psoriasis, the mainstay therapies tend to be steroid-based, which cannot be used long term and have side effects. In the management's opinion, there is a clear unmet clinical need for new, safer ways of treating patients with mild to moderate psoriasis. In addition, anecdotal evidence from patients suggests that as a result of preferring more 'natural' treatments, many have turned to oral probiotics as an 'alternative' therapy and have reported success in control of their disease. To date, scientific evidence is scarce; the effects of probiotics on psoriasis have been investigated in only two studies which did not make the choice of probiotic organisms based on known disease pathways.

In February 2020, the Company signed a development agreement with Winclove, a specialist in the research, development and manufacture of probiotic food formulations and supplements. The agreement is targeting the development of a probiotic blend of 'good' bacterial strains based on the modifying properties of specific bacterial species on known psoriasis disease pathways. In July 2020 Winclove reported that it had been able to successfully combine and formulate the blend as a probiotic food supplement, to be known as AxisBiotix™Ps. This is a major step forward for the development process.

Unable to pursue its originally proposed human study because of COVID-19, the management adapted quickly to the situation and established a protocol for, and is proceeding with, a 'self-managed' food supplement study. Participants will be invited to participate in a human study in which they will be provided with samples of AxisBiotix™Ps to self-administer over an eight-week period. They will be asked to track the impact of the food supplement on their skin condition themselves. Participants will submit their findings on a periodic basis through a bespoke mobile device app, thus avoiding the need for clinical attendance. This will accelerate the timing of readout compared to the previously envisaged conventional study. As a result, if the findings are positive, this will allow for a significantly earlier commercial launch than originally planned. The Company anticipates the trial commencing in Q1 2021.

· MediBiotix

The MediBiotix channel will focus on medical device applications incorporating the SkinBiotix® technology. The initial target is eczema and, following review of the submitted data pack by the MHRA (Medicines and Healthcare products Regulatory Agency), the Company is progressing further research work in the lab to support the required characteristics of a medical device application. This work was halted by the temporary closure of the lab facilities at the University of Manchester, however recommenced in September.

Management also believes there is utility for the technology in the treatment of various classes of skin wounds and is in discussion with a number of global advanced woundcare companies in this regard. The Company is targeting a commercial agreement to develop and test the SkinBiotix® technology in these indications.

· CleanBiotix

The area of healthcare acquired infections (HAI) remains an area of critical concern for healthcare providers and the ongoing pandemic has brought contact infection into sharp focus. The growing resistance of certain infection strains and the lack of new antibiotics is driving the need to discover and develop new methods of controlling bacterial growth and infection.

Staphylococcus aureus (SA) is the most common skin pathogen and one of the major causes of HAI. The Company's SkinBiotix® technology has been shown to have capabilities in preventing SA from adhering to and growing on the skin and thus offers a potential route of protection from SA-induced healthcare acquired infections.

The Company is investigating whether SkinBiotix® offers utility to protect other non-human surfaces and interfaces from SA induced healthcare acquired infections and is in early stage commercial discussions with a number of interested parties.

· PharmaBiotix

As an extension to medical device and Axis applications, the Company has the potential to pursue medicinal prescription registration routes for current and future technologies. This is a time-consuming and expensive pathway with significantly higher barriers to entry, but subject to positive clinical outcomes, has the potential for significantly higher financial returns.

Whilst SkinBioTherapeutics is not currently targeting this channel, it is a future potential pathway for both the eczema and psoriasis opportunities and a natural progression from both MediBiotix™ and AxisBiotix™.

Financial review

Operating expenditure increased during the course of FY 2020, in line with management forecasts. Research and development expenditure was £635k (2019: £708k) comprised predominantly of development work with the University of Manchester and internal employment costs. Expenditure was lower than anticipated in the final quarter of the year with the temporary closure of the laboratory facilities at the University of Manchester.

Ongoing operating costs were £985k (2019: £652k) covering employment, consultancy, PLC support costs and marketing. Overall, the Company made a loss before tax of £1,620k (2019: £1,360k).

The Company held £2.2m of cash at year-end (2019: £3.1m), a position that benefited from the suspended activity at the University of Manchester and receipt of £211k in June 2020 from the Company's R&D tax credit reclaim. In November 2020, the Company completed a placing and open offering, raising £4.45m in gross proceeds.

Outlook

The Company has made significant progress through the course of the year with commercial deals signed in two of its five core areas and key scientific milestones achieved with its partners in both these areas. This is especially pleasing given the difficult operational environment arising due to the COVID-19 pandemic. The Company's financial position was further strengthened with the successful placing and open offer. The funding enables the Company to expand its technology pipeline with further work in areas such as hair and oral care and UV protection, and support the transition from a virtual operation to one with an in-house scientific capability.

Looking forward to the new financial year, as Croda continues to progress the pathway of the SkinBiotix® technology as a cosmetic ingredient, a key focus for the Company will be the AxisBiotix™ programme targeting psoriasis. Here the Company is seeking to initiate and complete a 'self-managed' human study in Q1 2021 and, subject to a positive readout, commence commercialisation. This is an accelerated timeframe to that originally anticipated but equally presents an opportunity for a more rapid route to revenue generation.

Stuart J. Ashman

CEO

Income statement

For the year ended 30 June 2020

Statement of financial position

As at 30 June 2020

Statement of cash flows

For the year ended 30 June 2020

Statement of changes in equity

For the year ended 30 June 2020

Extracts of the notes to accounts

1. General information

SkinBioTherapeutics plc is a public limited company incorporated in England under the Companies Act and quoted on the AIM market of the London Stock Exchange (AIM: SBTX). The principal activity of the Company is the identification and development of technology that harnesses the human microbiome to improve health.

On 2 November 2020 the Company completed a placing and open offer to new and existing shareholders raising a total of £4.45m.

No other material subsequent events have occurred that would require adjustment to or disclosure in the financial statements.

A copy of this announcement may be found on the Company's website today and is included in the Annual Report and Accounts which will be published later today.

The Company's Annual General Meeting will be held on 29 December 2020 at 11am at the offices of Penningtons Manches Cooper LLP, 125 Wood Street, London, EC2V 7AW.

The financial information set out in this announcement does not constitute the Company's statutory accounts for the years ended 30 June 2019 or 30 June 2020. The financial information for the year ended 30 June 2019 is derived from the statutory accounts for that year which have been delivered to the Registrar of Companies. The auditors reported on those accounts: their report was unqualified, did not draw attention to any matters by way of emphasis and did not contain a statement under s498(2) or (3) of the Companies Act 2006.

The financial information for the year ended 30 June 2020 is derived from Company's financial statements for the year ended 30 June 2020 which were approved by the directors on 3 December 2020. The auditors reported on those accounts: their report was unqualified, did not draw attention to any matters by way of emphasis and did not contain a statement under s498(2) or (3) of the Companies Act 2006. These accounts will be delivered to the registrar in due course.

Whilst the financial information included in this announcement has been computed in accordance with International Financial Reporting Standards (IFRS), this announcement does not in itself contain sufficient information to comply with IFRS. The accounting policies used in preparation of this announcement are consistent with those in the full financial statements that have yet to be published.

Full notes to this statement are contained in the Company's Annual Report and Accounts.