TIDMSBTX
RNS Number : 7467S
SkinBioTherapeutics PLC
05 October 2017
SkinBioTherapeutics plc
Full year results
Manchester, UK - 5 October 2017 - SkinBioTherapeutics plc (AIM:
SBTX or the "Company") a life sciences company focused on skin
health, has announced its full year results for the year to 30 June
2017.
Key highlights
-- Research agreement with the University of Manchester for
'development of a bacterial lysate as a
novel agent to combat infections'
-- Successful demonstration of the three modes of action of the SkinBiotix(R) technology
-- Creating a strong Board and management team for the
development and commercial phase of the Company
-- Admission to AIM in April 2017 raising GBP4.5m
-- Initiating scale up of lysate manufacture with third parties
-- Cash as at 30 June 2017 GBP3.9m (2016: GBP0.3m)
-- Post year end: SkinBiotix(R) passed cytotoxicity test,
representing first key milestone post IPO
Cath O'Neill, CEO of SkinBioTherapeutics, said:
"This has been a significant year for the Company; from creating
the infrastructure and team to support the growth and development
of the Company, to the scientific progress around our proprietary
skin platform, SkinBiotix(R).
"During the year, we have demonstrated three significant
properties - barrier improvement, anti-infection and repair - which
form the foundations of our three development programmes. We are
making good scientific headway and are starting initial discussions
with partners.
"Operationally, we have made a good start to the new financial
year, especially with the recent news around the third party
cytotoxicity testing, and we look forward to reporting on the next
phase of the Company's journey."
The information communicated within this announcement is deemed
to constitute inside information as stipulated under the Market
Abuse Regulations (EU) No. 596/2014. Upon the publication of this
announcement, this inside information is now considered to be in
the public domain.
-Ends-
For more information, please contact:
SkinBioTherapeutics plc Tel: +44 (0) 161 468 2760
Dr. Cath O'Neill, CEO
Doug Quinn, CFO
Cairn Financial Advisers LLP Tel: +44 (0) 20 7213 0880
Tony Rawlinson / Emma Earl / Richard
Nash
Turner Pope Investments Tel: +44 (0) 20 3621 4120
Ben Turner / James Pope
Instinctif Partners Tel: +44 (0) 20 7457 2020
Melanie Toyne-Sewell / Deborah SkinBio@instinctif.com
Bell
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
SkinBioTherapeutics' is reporting its first year of results as a
public company for the year ended 30 June 2017. FY2017 has been a
significant year for the Company, peaking with its admission to
AIM.
SkinBioTherapeutics is built around the technology,
SkinBiotix(R), which has been acquired from the University of
Manchester. The management's focus for the year has been on
creating the infrastructure to support SkinBiotix(R)'s application
in the exciting and emerging field of science, the skin
microbiome.
Key operational achievements which are described more fully in
the CEO's report include:
-- Entering a research agreement with the University of
Manchester for the 'development of a bacterial lysate as a novel
agent to combat infections'
-- Successful demonstration of the three modes of action of the
SkinBiotix(R) technology - barrier improvement, protection against
Staphylococcus aureus (S. aureus) and skin repair
-- Initiating the scale-up of lysate manufacture and formulation with third parties
-- Progressing each of the development programmes in skin care, anti-infection and eczema
A new Board and management team was established prior to the
admission of the Company to AIM. The Board comprises founder and
CEO Dr. Catherine O'Neill, CFO Doug Quinn, Martin Hunt as
Non-Executive Chairman and Non-Executive Directors Dr. Cathy
Prescott and Stephen O'Hara, the CEO of OptiBiotix Health Plc, the
Company's largest shareholder. The team has varied expertise and a
strong commercial and technical track record, and has worked well
together since IPO.
Financially, the year included the Company's successful
admission to AIM of the London Stock Exchange and Placing which
raised GBP4.5m from the issue of 50,000,000 new ordinary
shares.
At IPO the management team identified the following objectives
to build value for shareholders:
-- Continued development of its SkinBiotix(R) technology
platform
-- Cytotoxicity testing in 2017 prior to preparation of the
human study
-- Completion of a cosmetic human study in 2018
-- Secure partnering and licensing opportunities
-- Further development targeting treatments for infection
control and eczema
The IPO has been transformational for the business in terms of
providing the funding and resources to support the Company through
its initial stage of development.
Since the year end, the focus has been on achieving positive
third party validation of the SkinBiotix(R) technology with respect
to toxicity, and the manufacture and scale-up of the lysate. In
October 2017, the Company achieved positive cytotoxicity results,
and therefore has cleared an important hurdle before the technology
can continue into human studies. In the accompanying scientific
update, good progress was reported with respect to formulation and
manufacturing scale-up.
As the programmes progress and the collection of robust and
efficacious scientific data builds, partnerships and licensing
agreements will be key aspects of the business model; very early
discussions have begun. The Company will continue to actively seek
to develop relationships in the industry.
Conclusion
The microbiome, and in particular the skin microbiome, is an
area gaining an increasing level of interest and attention. The
Board believes that a strong scientific grounding of the technology
is key for differentiation in what will become an increasingly
competitive market, particularly for the cosmetic applications. The
Board has confidence in the management team to establish a strong
position as a prominent 'science led' business and thus building
long term value for its shareholders.
Martin Hunt
Chairman
CEO's STATEMENT
Overview
SkinBioTherapeutics was established in March 2016 with the
acquisition of technology and intellectual property called
SkinBiotix(R) from the University of Manchester. SkinBiotix(R) is
based upon discoveries made at the university by CEO and
co-founder, Dr. Catherine O'Neill and co-founder, Professor Andrew
McBain.
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 the technology in the areas of
cosmetics, the prevention of S. aureus infection and as treatment
to reduce the incidence of eczema flares. The Company is looking to
demonstrate viability for these applications through continued
development and human studies as a route to commercialise the
technology through partnerships and licencing opportunities.
This financial year has been one of securing the SkinBiotix(R)
technology and intellectual property, building the team, and
creating the financial and scientific infrastructure to build
future value. The IPO and placing in April 2017 was a major
achievement for the Company and will support the strategy in the
short to medium term.
The early strategic goals have been achieved this year and the
Company is on track to take its first application for cosmetic use
into human trials in 2018.
Financial results
The Company is an early stage life science company and therefore
is pre-revenue. In October 2016 the Company drew down a loan of
GBP400k from Optibiotix Health Plc to provide working capital in
anticipation of an IPO. Having completed the transfer of
intellectual property from the University of Manchester and having
available working capital the Company began incurring
expenditure.
Ongoing operating costs were GBP305k (period ended 30 June 2016:
GBP6k) covering employment, consultancy fees, recruitment and
marketing. R&D expenditure was GBP157k (period ended 30 June
2016: GBP1k) comprising primarily work from the development
agreement contracted to the University of Manchester. Overall the
Company made a loss before tax of GBP688k (period ended 30 June
2016: GBP4k).
In April, the Company was admitted to AIM on the London Stock
Exchange with the ticker, SBTX, at a market capitalisation of c.
GBP6m. At the same time, it raised GBP4.5m from the placing of
50,000,000 new ordinary shares at 9 pence per share. Of the costs
related to the AIM admission GBP211k were expensed with a further
GBP545k written off against the share premium reserve. Included
within the costs expensed was a non-cash charge of GBP80k related
to the issue of warrants.
As a result of the fund raising, the Company has significantly
improved its cash position and held GBP3.9m at the year end (at 30
June 2016: GBP0.3m). These funds will be used to progress the
Company's three development programmes and support the other
operating costs of the business.
Technology
SkinBioTherapeutics proprietary technology, SkinBiotix(R) is
based on the properties of the human microbiome.
The microbiome encompasses the genetic content of all the
bacteria in and on the human body. Whereas humans possess around
23,000 genes, the human microbiome contains roughly 1,000,000 genes
and consequently has a huge potential to be able to change the way
the body functions.
The best understood aspects of the microbiome are the bacteria
that live in the gut and has led to the rise in ingesting
'probiotics' to promote health. These probiotics are live
micro-organisms which are usually members of the gut microbiota
where they are well known for their positive effects.
To date, the majority of focus within the probiotics industry
has been placed upon ingestible applications of probiotics.
However, microbiologists, immunologists and dermatologists are now
beginning to unlock the importance of how skin interacts with
bacteria.
SkinBiotix(R) is an innovative technology, 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 also the potential formulation
difficulties of keeping bacteria alive in a cream.
Development programmes
SkinBioTherapeutics has three development programmes underway
based on the positive properties of SkinBiotix(R).
1) Skin Protection - Cosmetic
With a relatively quick route to market, the first application
for the SkinBiotix(R) technology is a cosmetic cream for skin
health.
Proof of principle studies, in skin models, have demonstrated
that the SkinBiotix(R) technology improves the function of 'tight
junctions' and consequently the protective barrier offered by skin.
Tight junctions enable the skin's ability to function as a tough,
waterproof protective barrier. These structures physically block
the spaces between adjacent skin cells and prevent the entry of
pathogens, and toxins etc. as well as reducing the loss of water
from within the body.
The barrier-enhancing features of SkinBiotix(R) will be to
promote general skin health and improve moisture retention along
with skin smoothness.
During the year, the priorities have been to continue building
the scientific data pack in preparation for future clinical trials,
as well as scaling up manufacture. These developments have
progressed well and are on track. The recent positive cytotoxicity
result, reported in October 2017, confirm SkinBiotix(R)'s benign
properties towards skin cells and is a major step forward on the
road to moving this programme towards human studies in 2018.
2) Skin Management - anti-infection
Early data shows that SkinBiotix(R) prevents the attachment of
the most common of skin pathogens, S.aureus to skin cells. This
property forms the basis for the Company's second programme to
reduce the risk of Healthcare Acquired Infections (HCAIs).
S.aureus is implicated in a range of skin conditions from
relatively mild diseases such as impetigo, to life threatening
septicemia. Infections can be treated successfully with
antibiotics, but resistant strains, such as Methicillin-Resistant
Staphylococcus Aureus ("MRSA"), are emerging. Growing resistance
and the lack of new antibiotics is driving the need for new methods
of controlling bacterial growth, colonisation and infection,
particularly in the hospital environment. Infection protection and
management is an ever-increasing absorber of resources for
healthcare providers.
The priority for SkinBioTherapeutics' programme is testing
SkinBiotix's inhibitory activity in skin cells against a panel of
bacterial strains known to be of importance in HCAIs. This activity
profiling will direct the development and clinical testing of
formulations and product positioning approaches which target
harmful infectious bacterial strains. Albeit at an early stage
compared to the cosmetic programme, good progress has been
made.
3) Skin Restoration - Eczema
The properties of the SkinBiotix(R) technology create
opportunities for demonstrating its efficacy in the prevention and
management/treatment of skin diseases for example, adult and
paediatric atopic dermatitis or eczema. This is the focus of the
third development programme.
The importance of an intact skin barrier is demonstrated by the
body's response to a breach in the barrier i.e. a wound or burn
where there is an increase in infection risk. When the skin is
wounded, the skin cells (keratinocytes) proliferate and migrate
across the wound site to attempt to fill in the gap. This happens
quickly in healthy individuals but in some patients with underlying
problems e.g. eczema, diabetes, the skin can be slow to heal. A
delay in healing can leave the body exposed to potential
infection.
The Company has yet to fully validate an indication, although
SkinBiotix(R) has properties that indicate it could be used as a
supportive treatment in eczema.
This is the earliest programme in development and again,
progress is being made to plan.
The long term intention is for pre-clinical testing to be
performed to validate the indication prior to entering human study
programmes. Due to the size of the market, the Company will seek a
partner for development and commercialisation.
Scientific and development update
To date SkinBioTherapeutics has completed studies using human
skin models, successfully demonstrating the three modes of action
of the SkinBiotix(R) technology to protect, manage and restore
skin.
The immediate priorities for the cosmetic application are to
progress the technology through the manufacture upscaling of the
SkinBiotix(R) lysate and prototype formulation. These are key
milestones which must be passed prior to the start of human studies
and to complete the validation stage. Further updates are expected
by the end of the calendar year.
Lysate production so far has been in small batches with further
work completed to assess performance following extended storage and
at varying temperatures. The Company has begun engaging with third
parties for the external production of lysate that achieves the
same performance results and with commercial scale production in
mind.
Formulation is critical because SkinBiotix(R) activity must be
maintained whilst in a cream or gel form. The Company has engaged a
formulation specialist who has started work on this.
During the year, the Company initiated independent cytotoxicity
testing on the lysate. In October 2017, the Company announced that
the lysate had passed the cytotoxic tests. This result is an
important key requirement of the Product Information File (PIF)
required for regulatory purposes and marks the achievement of a
major milestone highlighted at IPO.
Outlook
SkinBioTherapeutics' admission to AIM was a big step forward for
the Company and it has made significant progress in the short time
since April as detailed above and in the Scientific Update released
in October 2017.
The Company is now in an important development phase as it looks
to establish manufacture scale-up, prototype formulation and
prepare for the initial human study with the skin care programme.
The human study, in particular, will be performed at a contract
research organisation, both for regulatory purposes and to ensure
the skin benefits that were evidenced through laboratory testing
are also apparent within the final formulation.
Given that all three programmes are targeting multi-billion
pound markets, each one will require a development and commercial
partner for the longer term. As highlighted at IPO, the Company and
its programmes are still at a relatively early stage for commercial
discussions. However, there are early signs of industry interest in
the Company's progress and the management team will be using their
extensive connections to develop these relationships further.
The Board and management team are confident about the progress
made to date and the outlook of the business.
Dr Cath O'Neill
CEO
Income statement
For the year ended 30 June 2017
Notes For the year For the period
ended 30 from 10 June
June 2017 2015 to 30
June 2016
Continuing Operations GBP GBP
Other income 5 3,000
Research and development costs (156,726) (1,400)
Initial public offering costs (211,477) -
Operating expenses (304,501) (5,801)
------------- ---------------
Loss from operations 2 (672,699) (4,201)
Finance costs (15,540) -
------------- ---------------
Loss before taxation (688,239) (4,201)
Taxation 42,685 -
------------- ---------------
Loss for the year (645,554) (4,201)
Other comprehensive income - -
Total comprehensive loss for the
year (645,554) (4,201)
============= ===============
Basic and diluted loss per share
(pence) 3 (1.11) (0.03)
Statement of financial position
As at 30 June 2017
As at 30 As at 30
Notes June 2017 June 2016
GBP GBP
Assets
Non-current assets
Intangible assets 215,412 136,214
----------- ---------------
Total non-current assets 215,412 136,214
----------- ---------------
Current assets
Other receivables 151,189 30,607
Other current assets 42,685 -
Cash and cash equivalents 3,922,903 256,667
----------- ---------------
Total current assets 4,116,777 287,274
----------- ---------------
Total assets 4,332,189 423,488
=========== ===============
Equity and liabilities
Equity
Capital and reserves
Called up share capital 1,187,085 1,000
Share premium 3,577,640 393,048
Other reserves 98,559 -
Accumulated deficit (649,755) (4,201)
Total equity 4,213,529 389,847
----------- ---------------
Liabilities
Current liabilities
Trade and other payables 118,660 33,641
Total current liabilities 118,660 33,641
----------- ---------------
Total liabilities 118,660 33,641
----------- ---------------
Total equity and liabilities 4,332,189 423,488
=========== ===============
Statement of cash flows
For the year ended 30 June 2017
For the
period from
10 June
For the year 2015 to
ended 30 30 June
June 2017 2016
GBP GBP
Cash flows from operating activities
Loss before tax for the period (688,239) (4,201)
Convertible loan interest paid
as equity 15,540 -
Share option expenses 98,559 -
(lncrease) in trade and other receivables (120,582) (30,607)
Increase in trade and other payables 85,019 33,641
Net cash used in operating activities (609,703) (1,167)
Cash flows from investing activities
Payments for intangible assets (79,198) (136,214)
Net cash used in investing activities (79,198) (136,214)
Cash flows from financing activities
Net proceeds from issue of equity instruments
of the Company 3,955,137 394,048
Net proceeds from issue of convertible
loan notes 400,000 -
Net cash generated by financing
activities 4,355,137 394,048
Net increase in cash and cash equivalents 3,666,236 256,667
Cash and cash equivalents at the beginning
of the period 256,667 -
------------- -------------
Cash and cash equivalents at the end
of the period 3,922,903 256,667
============= =============
Statement of changes in equity
For the year ended 30 June 2017
Share Share Other Retained
capital premium reserves earnings Total
GBP GBP GBP GBP GBP
As at 10 June 2015 -
Loss for the period (4,201) (4,201)
Issue of shares 1,000 393,048 394,048
As at 30 June 2016 1,000 393,048 - (4,201) 389,847
Loss for the period (645,554) (645,554)
Issue of shares 893,048 3,062,089 3,955,137
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
========== ========== ========== ========== ==========
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
These financial statements reflect the financial performance and
position of SkinBioTherapeutics plc for the period from 10 June
2015 to 30 June 2017 (made up of the period from 10 June 2015 to 30
June 2016 and the year ended 30 June 2017.
SkinBioTherapeutics is a public limited company incorporated in
the United Kingdom under the Companies Act and quoted on the AIM
market of the London Stock Exchange (AIM: SBTX). The address of its
registered office is given on page 1.
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
2017 2016
GBP GBP
An analysis of the Company's operating loss has been arrived at
after charging/(crediting):
Other income (5) (3,000)
Research and development 156,726 1,400
Directors remuneration (including share based
compensation) 41,843 -
Auditors remuneration
- audit fees 14,000 2,750
- other services 11,049 -
Foreign exchange differences 69 -
Other operating costs 237,540 3,051
IPO expenses 211,477 -
Total operating expenses 672,699 4,201
=================== ====================
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
2017 2016
GBP GBP
Basic and diluted loss per
share
Loss after tax (GBP) (645,554) (4,201)
Weighted average number of
shares 58,307,324 13,654,221
------------------- --------------------
Basic and diluted loss per
share (pence) (1.11) (0.03)
=================== ====================
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. Convertible loans
On 31 October 2016, the Company drew down a loan of GBP400,000 ("Loan")
under a term loan facility agreed on 13 October 2016 with its parent
company to fund its ongoing working capital requirements. The Loan
was unsecured, bearing interest at a rate of 5% per annum, and repayable
in full on 30 September 2020. The Loan was converted into 1 ordinary
share in the company for every GBP0.01365 of the Loan prior to admission
to AIM on 5 April 2017.
Value of liability component and equity conversion
component
The values of liability component and equity conversion component
were determined at issuance of the convertible loan. The liability
component of the Loan was calculated using a market interest rate
for an equivalent non-convertible loan with effective interest rates
of 12% at initial recognition. The residual amount, representing
the value of the equity conversion component, was included and presented
in equity under the heading of "other reserves".
GBP
Proceeds of issue 400,000
Liability component at the
date of issue (306,849)
Equity component 93,151
====================
Conversion
The effective interest was calculated immediately prior to conversion
and recognised in the Statement of Comprehensive Income, and the
remaining liability component of the Loan converted to equity.
GBP
Liability component at the
date of issue 306,849
Interest charged up to conversion date at an effective
interest rate of 12% 15,540
Interest paid -
Liability component immediately before conversion
on 5 April 2017 322,389
====================
GBP
Liability component immediately before conversion
on 5 April 2017 322,389
Equity component 93,151
Total converted to
equity 415,540
====================
Share Capital Share Premium
Number GBP GBP
Equity converted
into: 29,303,694 293,037 122,503
The financial information set out in this announcement does not
constitute the company's statutory accounts for the period ended 30
June 2016 or the year ended 30 June 2017. The financial information
for the period ended 30 June 2016 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 2017 is
derived from Group's financial statements for the year ended 30
June 2017 which were approved by the directors on 4 October 2017.
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. A copy of this announcement may be
found on the Company's website today and the Company's Annual
Report and Accounts will be published in due course.
This information is provided by RNS
The company news service from the London Stock Exchange
END
FR OKQDQOBDDAKK
(END) Dow Jones Newswires
October 05, 2017 02:00 ET (06:00 GMT)
Skinbiotherapeutics (LSE:SBTX)
Historical Stock Chart
From Apr 2024 to May 2024
Skinbiotherapeutics (LSE:SBTX)
Historical Stock Chart
From May 2023 to May 2024