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| Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
|---|---|---|---|---|---|
| Skinbiotherapeutics Plc | LSE:SBTX | London | Ordinary Share | GB00BF33H870 | ORD 1P |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 9.25 | 9.00 | 9.50 | 9.25 | 9.25 | 9.25 | 2,727 | 08:00:00 |
| Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
|---|---|---|---|---|---|
| Biological Pds,ex Diagnstics | 132k | -2.84M | -0.0163 | -5.67 | 16.1M |
From Apr 2019 to Apr 2024
TIDMSBTX
RNS Number : 1031F
SkinBioTherapeutics PLC
25 October 2018
SkinBioTherapeutics plc
Full year results
Manchester, UK - 25 October 2018 - SkinBioTherapeutics plc (AIM: SBTX - "SkinBioTherapeutics" or the "Company") a life sciences company focused on skin health, has announced its full year audited results for the year to 30 June 2018.
Key highlights
-- SkinBiotix(R) passed key cytotoxicity safety tests
-- Replication of lysate manufacturing process by a third party and successful industrial volume scale-up
-- Production of a cream formulation that demonstrated effectiveness of SkinBiotix(R) technology
-- Expansion of intellectual property portfolio, with patents granted in Australia, Russia and New Zealand
-- Signing an MTA (Material Transfer Agreement) with global consumer goods company -- Ethics approval for cosmetic human study -- Extension to University of Manchester research agreement -- Cash as at 30 June 2018 GBP3.2m (2017: GBP3.9m) -- Post year end: commenced first human cosmetic studies
Cath O'Neill, CEO of SkinBioTherapeutics, said:
"This year, our focus has been on preparing the SkinBiotix(R) technology for its first human study and longer-term preparations for commercialisation. On both fronts, we have made good progress.
"Firstly, we have demonstrated that our lysate can be freeze dried and scaled-up to industrial levels. On the commercial front, we have an ongoing dialogue, including an MTA, with a range of major FMCG and cosmetic companies who are taking a close interest in our technology and progress.
"Post year end, we initiated the cosmetic human studies which was a major milestone for the Company. On the basis that the results are positive, the validation will strengthen our position as a science-led business and enable further commercial discussions."
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-
For more information, please contact:
Hot Features
Premium
SkinBioTherapeutics plc Tel: +44 (0) 161 468
Dr. Cath O'Neill, CEO 2760
Doug Quinn, CFO
Cairn Financial Advisers LLP (Nominated Tel: +44 (0) 20 7213
Adviser) 0880
Tony Rawlinson / Sandy Jamieson / Richard
Nash
Turner Pope Investments (Joint Broker) Tel: +44 (0) 20 3621
Ben Turner / James Pope 4120
Northland Capital Partners (Joint Broker)
Dugald Carlean Tel: +44 (0) 20 3861
6625
Instinctif Partners (Media Relations) Tel: +44 (0) 20 7457
Melanie Toyne-Sewell / Deborah Bell / 2020
Alex Shaw SkinBio@instinctif.com
Notes to Editors
About SkinBioTherapeutics plc
SkinBioTherapeutics is a life science company focused on skin health. The Company's proprietary platform technology, SkinBiotix(R), 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(R) 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(R) 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(R). 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 GBP4.5 million from a placing of new ordinary shares.
The Company is based in Manchester, UK. For more information, visit www.skinbiotherapeutics.com.
Chairman's Statement
During the past financial year, SkinBioTherapeutics' has focused on the development of its SkinBiotix(R) technology platform and the preparations for the start of the cosmetic human study.
The Company has made significant progress across all aspects of these business objectives. The manufacturing process has been driven forward, from the scale-up of the lysate material through to the development of a cosmetic formulation. Having formulated a cream and demonstrated the extended stability of the technology, the Company has also been able to begin the first phase of its human study in September 2018. This is an important milestone for the business and a key step towards the future commercialisation of the technology.
Costs have been managed carefully and the Company ended the year with a cash balance of GBP3.2m (2017: GBP3.9m), which is line with management's expectations.
Other key operational achievements which are described more fully in the CEO's report include:
-- SkinBiotix(R) passed key cytotoxicity safety tests
-- Replication of the lysate manufacturing process by a third party and industrial volume scale-up
-- Production of a cream formulation that demonstrated the effectiveness of the SkinBiotix(R) technology
-- Granting of patents in Australia, Russia and New Zealand -- Signing an MTA (Material Transfer Agreement) with a global consumer goods company -- Provisional ethics approval for the cosmetic human study -- Progress with the eczema and infection programmes -- Extension to the research agreement with the University of Manchester.
Interest in the microbiome as a sector continues to grow and it is noteworthy that the cosmetic industry is transitioning to products and applications with scientific validation. This latter development has been an important factor in the discussions the Company has had to date with potential commercial partners. This reaffirms SkinBioTherapeutics' strategic approach to establish itself as a 'science-led' skin healthcare business.
During the current financial year, the Company expects to complete its first human study and further commercial negotiations in partnering and licensing opportunities.
Martin Hunt
Chairman
CEO's Statement
Overview
SkinBioTherapeutics seeks to harness the microbiome for human health. The best understood members of the microbiome are the bacteria that live in the gut and these have led to the rise in ingesting 'probiotics' to promote health. However, an increasing area of focus is the microbiome of the skin.
SkinBioTherapeutics' proprietary technology, SkinBiotix(R), 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 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.
The Company is developing SkinBiotix(R) to address a number of indications and has an ongoing research agreement with the University of Manchester to identify and develop new and different technologies. Proof of principle studies have shown that the molecules found in the human microbiome can be used to protect, manage and restore the skin. On the basis of this data, the Company has identified potential applications for SkinBiotix(R) in the areas of cosmetics, the reduction in the incidence of eczema flares and for the prevention of infection.
Commercially, the Company intends to license its technologies to large corporates once human proof-of-principle has been established and generate income through licence revenue. The Company is in early level discussions with a number of third parties and in April this year signed an MTA with a global consumer goods company.
Dialogues are continuing with each of the engaged parties and a common theme from the discussions is the focus on scientific validation which reinforces SkinBioTherapeutics' strategy to position itself as a prominent 'science led' business. To this end the directors anticipate more tangible progress on the commercial discussions on the readout of the cosmetic human study.
This route to commercialisation, in conjunction with the approach to R&D with the University of Manchester, enables the Company to operate virtually with a small employee base and a consequently low cost of operations.
Financial review
Whilst operating expenditure has increased following the Company's IPO in April 2017, this is in line with management forecasts and the Company held GBP3.2m of cash at the year-end (2017: GBP3.9m).
Research and development expenditure was GBP416k (2017: GBP157k) comprising development work with the University of Manchester and the manufacture, scale up and preparatory work for the cosmetic human study.
Ongoing operating costs were GBP526k (2017: GBP305k) covering employment, consultancy, PLC support costs and marketing.
Overall the Company made a loss before tax of GBP941k (2017: GBP688k).
Operational review
During the year the Company achieved several important milestones with its SkinBiotix(R) technology - manufacture of the lysate, the passing of key safety studies and the successful formulation of the technology into a cream.
Manufacture of the lysate had previously only been achieved on a small scale in the laboratory. However, the process of manufacture has now been successfully replicated with a third party and subsequently scaled up by to a level appropriate for commercialisation.
In addition, the base lysate material, which to date has been manufactured and supplied in a liquid form, has now been successfully freeze dried. The ability to freeze dry a material of this kind is an important step towards commercialisation as it enables mass production, storage and transportation.
The technology has also passed various cytotoxicity tests and demonstrated that it is safe to use on human skin. The studies were performed by Charles River Laboratories, a global contract research organisation (CRO). The CRO tested for adverse reactions to the use of the SkinBiotix(R) technology, firstly when applied to human cells, secondly after exposure to UV and visible light and thirdly when applied to eye cells. Successfully passing these studies was a precursor to progressing the cosmetic human study.
Cosmetic programme
With the scale-up and manufacture of the SkinBiotix(R) technology finalised, the focus with the cosmetic programme has been to establish a formulation, containing SkinBiotix(R), that can be applied to the skin and perform in the same way as the technology on its own.
Having achieved this with a cream, the formulation was then tested for its stability. Stability addresses the requirement of the technology to be effective within the formulation over an extended period of time. This stability is specific to the formulation required for the human study and the study duration. The Company is not intending to market the cream, rather the technology will be licensed to a third party who will incorporate it into a product formulation with the requisite stability.
In September 2018, the Company announced it had started its human study which comprises three sub components with data readouts occurring between November 2018 and April 2019.
Other programmes
Work in the lab this year has demonstrated that SkinBiotix(R) fulfils a 'physical mode of action' with regard to the pathogen Staphylococcus aureus (S. aureus), i.e. it prevents the attachment of S. aureus to the skin. The skin of eczema sufferers is commonly infected with S. aureus and there is documented evidence that this infection is the most common cause of eczema flares. On this basis, technologies that can reduce S. aureus load on skin have the potential to reduce the incidence of flares.
The physical mode of action of SkinBiotix(R) allows the Company to progress the eczema programme as a medical device rather than a pharmaceutical treatment. This regulatory pathway is potentially a faster route to market. The Company is working with its regulatory advisors to prepare the medical device dossier for submission to the notified body. Subject to acceptance of the eczema programme following the medical device pathway, the Company anticipates seeking approval in the second half of 2019 for the commencement of a clinical trial.
The Company considers the SkinBiotix(R) technology to have utility beyond general healthcare acquired infections and intends to broaden the scope to encompass specific skin infections, for example athlete's foot. The technology may also be effective in blocking the adhesion of other pathogens not only to skin but also in the oral cavity or on the scalp. Hence the Company envisages a development programme to test SkinBiotix(R) against a range of pathogens during the course of 2019.
Outlook
Having established manufacturing scale-up and formulated an effective cream, the human study initiated in September defined an important phase for the Company. A positive readout from the study will be an important validation of the SkinBiotix(R) technology and a basis to further progress the various commercial discussions that are in hand.
Reaffirming and progressing the eczema programme as a medical device following the preliminary regulatory assessment will also be a significant workstream in 2019 together with establishing programmes to address other skin infections and assess the impact of SkinBiotix(R) on other pathogens.
Good progress has been made this year across the business and the Board and management team are optimistic for the outlook in 2019.
Dr Cath O'Neill
CEO
Income statement
For the year ended 30 June 2018
Notes For the For the
year ended year ended
30 June 2018 30 June 2017
Continuing operations GBP GBP
Research and development (415,902) (156,726)
Initial public offering costs - (211,477)
Operating expenses (525,549) (304,496)
-------------- --------------
Loss from operations 2 (941,451) (672,699)
Finance costs - (15,540)
-------------- --------------
Loss before taxation (941,451) (688,239)
Taxation 97,033 42,685
-------------- --------------
Loss for the year (844,418) (645,554)
Other comprehensive income - -
Total comprehensive loss for the
year (844,418) (645,554)
============== ==============
Basic and diluted loss per share
(pence) 3 (0.71) (1.11)
Statement of financial position
As at 30 June 2018
Notes As at As at
30 June 2018 30 June 2017
GBP GBP
Assets
Non-current assets
Intangible assets 287,672 215,412
-------------- ------------------
Total non-current assets 287,672 215,412
-------------- ------------------
Current assets
Other receivables 93,421 151,189
Corporation tax receivable 86,272 42,685
Cash and cash equivalents 3,182,898 3,922,903
-------------- ------------------
Total current assets 3,362,591 4,116,777
-------------- ------------------
Total assets 3,650,263 4,332,189
============== ==================
Equity and liabilities
Equity
Capital and reserves
Called up share capital 1,187,085 1,187,085
Share premium 3,577,640 3,577,640
Other reserves 170,418 98,559
Accumulated deficit (1,494,173) (649,755)
Total equity 3,440,970 4,213,529
-------------- ------------------
Liabilities
Current liabilities
Trade and other payables 209,293 118,660
Total current liabilities 209,293 118,660
-------------- ------------------
Total liabilities 209,293 118,660
-------------- ------------------
Total equity and liabilities 3,650,263 4,332,189
============== ==================
Statement of cash flows
For the year ended 30 June 2018
For the For the
year ended year ended
30 June 30 June 2017
2018
GBP GBP
Cash flows from operating activities
Loss before tax for the period (941,451) (688,239)
Convertible loan interest paid as
equity - 15,540
Share option expenses 71,859 98,559
(869,592) (574,140)
------------ --------------
Changes in working capital
(lncrease)/decrease in trade and other
receivables 57,768 (120,582)
Increase in trade and other payables 90,633 85,019
------------ --------------
Cash generated by/(used in) operations 148,401 (35,563)
------------ --------------
Taxation received 53,446 -
Net cash used in operating activities (667,745) (609,703)
------------ --------------
Cash flows from investing activities
Payments for intangible assets (72,260) (79,198)
Net cash used in investing activities (72,260) (79,198)
------------ --------------
Cash flows from financing activities
Net proceeds from issue of equity instruments
of the Company - 3,955,137
Net proceeds from issue of convertible
loan notes - 400,000
Net cash generated by financing activities - 4,355,137
------------ --------------
Net (decrease)/increase in cash and cash
equivalents (740,005) 3,666,236
Cash and cash equivalents at the beginning
of the period 3,922,903 256,667
Cash and cash equivalents at the end
of the period 3,182,898 3,922,903
============ ==============
Statement of changes in equity
For the year ended 30 June 2018
Share Share Other Retained
capital premium reserves earnings Total
GBP GBP GBP GBP GBP
As at 1 July 2016 1,000 393,048 - (4,201) 389,847
Loss for the period - - - (645,554) (645,554)
Issue of shares 893,048 3,606,952 - - 4,500,000
Costs of share issue - (544,863) - - (544,863)
Issue of convertible loan
notes - - 93,151 93,151
Conversion of convertible
loan notes 293,037 122,503 (93,151) - 322,389
Share-based payments - - 98,559 - 98,559
As at 30 June 2017 1,187,085 3,577,640 98,559 (649,755) 4,213,529
Loss for the period (844,418) (844,418)
Issue of shares - - - - -
Costs of share issue - - - - -
Issue of convertible loan
notes - - - - -
Conversion of convertible
loan notes - - - - -
Share-based payments - - 71,859 - 71,859
As at 30 June 2018 1,187,085 3,577,640 170,418 (1,494,173) 3,440,970
============= ============= ========== ============ ==========
Share capital is the amount subscribed for
shares at nominal value.
Share premium is the amount subscribed for share capital in
excess of nominal value.
Other reserves arise from the equity element of a convertible loan
issued and converted in the period to
30 June 2017, and from share options granted on 5 April 2017
Retained earnings represents accumulated profit
or losses to date.
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 development of technology to protect, manage and restore skin utilising proteins found in the human microbiota.
2. Operating loss
30 June 30 June
2018 2017
GBP GBP
An analysis of the Company's operating loss has
been arrived at
after charging/(crediting):
Other income (84) (5)
Research and development 415,902 156,726
Directors remuneration (including share-based
compensation) 212,541 38,881
Auditors remuneration
- audit fees 10,995 14,000
- other services 1,750 11,049
Foreign exchange differences 345 69
Other operating costs 300,002 240,502
Initial public offering
costs - 211,477
Total operating expenses 941,451 672,699
================ ===========
The Company has one reportable segment, namely the research
and development of the Skinbiotix(R) technology, all within
the United Kingdom.
3. Loss per share
30 June 30 June
2018 2017
GBP GBP
Basic and diluted loss per
share
Loss after tax (GBP) (844,418) (645,554)
Weighted average number of
shares 118,708,494 58,307,324
Basic and diluted loss per
share (pence) (0.71) (1.11)
================ ===========
As the Company is reporting a loss from continuing operations
for the year then, in accordance with IAS 33, the share options
are not considered dilutive because the exercise of the share
options would have an anti-dilutive effect. The basic and
diluted earnings per share as presented on the face of the
income statement are therefore identical.
4. Posting of the Annual
Report and notice of
AGM
A copy of this announcement may be found on the Company's website today and the Annual Report and Accounts will be published later today.
The Company's Annual General Meeting will be held on 19 November 2018 at 11am at 111 Piccadilly, Manchester, M1 2HY.
The financial information set out in this announcement does not constitute the company's statutory accounts for the period ended 30 June 2017 or the year ended 30 June 2018. The financial information for the period ended 30 June 2017 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 2018 is derived from Group's financial statements for the year ended 30 June 2018 which were approved by the directors on 24 October 2018. 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.
This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.
END
FR BLBDGRXDBGIS
(END) Dow Jones Newswires
October 25, 2018 02:00 ET (06:00 GMT)
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