SkinBioTherapeutics plc
Half year results
Manchester, UK - 21 February 2018 - SkinBioTherapeutics plc (AIM: SBTX or the "Company") a life sciences company focused on skin health, has announced its half year results for the six months to 31 December 2017.
Key highlights
· Significant progress in developing the SkinBiotix® technology; successful initial lysate manufacture scale-up
· Three different formulation options for the cosmetic application are being assessed ahead of the human study scheduled in Q3 2018
· Anti-infection and eczema programmes progressing - application frequency and safe dosing levels determined
· Early stage commercial discussions with significant industry players continuing with respect to the cosmetic application
· Cash as at period end at £3.6m (2016: £0.4m)
Dr. Cath O'Neill, CEO of SkinBioTherapeutics, said:
"We have made significant progress in the past six months around our SkinBiotix® technology and we are on track with the advancement of all three indications in cosmetics, anti-infection and eczema.
"Our primary focus has been on developing the cosmetic application. Manufacturing scale-up and formulation is progressing to plan. As laid out at IPO, we intend to carry out the human safety study later this year.
"There is a growing awareness of our SkinBiotix® platform technology from the skin healthcare industry, based on the reputation of our team and our 'science-led' business approach. With continued work on our technology and the start of human studies in Q3, we are building further value for shareholders and a strong position from which to hold potential 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:
SkinBioTherapeutics plc Dr. Cath O'Neill, CEO Doug Quinn, CFO
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Tel: +44 (0) 161 468 2760 |
Cairn Financial Advisers LLP (Nominated Advisor) Tony Rawlinson / Emma Earl / Richard Nash
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Tel: +44 (0) 20 7213 0880 |
Turner Pope Investments (Joint Broker) Ben Turner / James Pope
Northland Capital (Joint Broker) John Howes / Tom Price
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Tel: +44 (0) 20 3621 4120
Tel: +44 (0) 20 3861 6625 |
Instinctif Partners Melanie Toyne-Sewell / Deborah Bell |
Tel: +44 (0) 20 7457 2020 |
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. Cath 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 PLC (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.
Chief Executive's Statement
Since the IPO last year, the SkinBioTherapeutics team has consistently delivered on the objectives presented in its admission document.
In the first half of this financial year, the priorities have been to expand the manufacture and scale-up capability and test the initial formulations. The progress made across all these areas has ensured that the Company remains on track to start its first human study for the cosmetic application in Q3 2018.
The execution and results of the first human study in Q3 2018 will be a key point for the development of the cosmetic product, which is already generating early, initial interest from potential commercial partners.
Financial review
Having raised gross proceeds of £4.5m through the IPO in April 2017, the Company ended the six month period in a strong position with £3.6m of cash.
R&D expenditure in the period was £125k and combined with other operating expenses of £261k resulted in a loss from operations of £386k.
R&D expenditure will continue to increase during the course of 2018 as the Company progresses towards the cosmetic human study and further develops the anti-infection and eczema programmes.
Operational review
There have been several operational achievements in the period, focusing on developing the SkinBiotix® technology platform.
· Manufacture scale-up
The manufacture of the lysate has been successfully replicated and scaled-up by a third party to 50 times the volume currently produced in the laboratory. The Company can now produce sufficient volumes to support the formulation work and the forthcoming cosmetic human study.
The next stage will be to achieve industrial size scale-up, which is underway.
· Formulation and human study
A third-party provider has successfully produced three different formulation options for the cosmetic application; a gel, a cream and a lotion.
SkinBioTherapeutics is currently assessing each form against its in-house human skin models to determine the performance of the technology when contained within each formulation. Subject to the results, modifications to the formulations may be required before the Company select one form to progress to the human volunteer study scheduled for Q3 2018.
The first in human study will be carried out over a 30 day period to assess skin hydration and barrier function. In parallel studies, the formulations will also be assessed in human volunteers to ensure that no inflammation to the skin occurs.
If positive, these data will allow the Company to use the term 'dermatologically tested' for its formulations.
· Further studies and other programmes
Further work has progressed well with the anti-infection and eczema programmes.
A 'time-course' study has confirmed that the frequency of application required for protection is three times daily. This indicates that for protection against Staphylococcus aureus infection, for both the eczema and anti-infection programmes, application will be required every five hours.
In addition, the Company has finalised a dosing level at which the technology can be used safely, for all three programmes. The team has also confirmed the modifying property of SkinBiotix® on the protein composition of the skin; the technology increases the expression of proteins which are essential for the barrier characteristics of skin.
With this programme progression, the management team has been able to build upon extensive industry relationships and early stage commercial discussions continue regarding both the cosmetic application and the core SkinBiotix® technology.
Outlook
The microbiome remains a popular field of science, with increasing focus on the skin microbiome. SkinBioTherapeutics has observed that the cosmetic industry is transitioning to products and applications with scientific validation. This reaffirms SkinBioTherapeutics' strategic approach to establish itself as a 'science led' business.
Having science at the business' core has been a key focus of discussions to date and with the completion of the initial human study, planned for later this year, the management team can further commercial negotiations in partnering and licensing opportunities.
Statement of Comprehensive Income
For the 6 months ended 31 December 2017
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Notes |
6 months to |
6 months to |
12 months to |
|
|
|
|
|
Unaudited |
Audited |
Audited |
|
|
|
|
|
£ |
£ |
£ |
|
Continuing operations |
|
|
|
|
|
||
Other income |
|
12 |
(3,000) |
5 |
|
||
Research and development costs |
|
(125,283) |
(89,952) |
(156,726) |
|
||
Initial public offering costs |
|
- |
(70,335) |
(211,477) |
|
||
Operating expenses |
|
(261,252) |
(85,549) |
(304,501) |
|
||
Loss from operations |
|
(386,523) |
(248,836) |
(672,699) |
|
||
Finance costs |
|
- |
(6,154) |
(15,540) |
|
||
Loss before taxation |
|
(386,523) |
(254,990) |
(688,239) |
|
||
Taxation |
4 |
43,479 |
25,627 |
42,685 |
|
||
Loss for the period |
|
(343,044) |
(229,363) |
(645,554) |
|
||
Other comprehensive income |
|
- |
- |
- |
|
||
Total comprehensive loss for the period |
|
(343,044) |
(229,363) |
(645,554) |
|
||
Basic and diluted loss per share (pence) |
6 |
(0.29) |
(0.58) |
(1.11) |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
Statement of Financial Position
As at 31 December 2017
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Note |
As at |
As at |
As at |
|
|
|
|
|
Unaudited |
Audited |
Audited |
|
|
|
|
|
£ |
£ |
£ |
|
ASSETS |
|
|
|
|
|
||
Non-current assets |
|
|
|
|
|
||
Intangible assets |
|
242,745 |
162,213 |
215,412 |
|
||
Total non-current assets |
|
242,745 |
162,213 |
215,412 |
|
||
Current assets |
|
|
|
|
|
||
Other receivables |
|
35,812 |
72,804 |
151,189 |
|
||
Other current assets |
|
86,164 |
25,627 |
42,685 |
|
||
Cash and cash equivalents |
|
3,649,476 |
397,180 |
3,922,903 |
|
||
Total current assets |
|
3,771,452 |
495,611 |
4,116,777 |
|
||
Total assets |
|
4,014,197 |
657,824 |
4,332,189 |
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||
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|
|
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EQUITY AND LIABILITIES |
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|
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Equity |
|
|
|
|
|
||
Capital and reserves |
|
|
|
|
|
||
Called up share capital |
5 |
1,187,085 |
394,048 |
1,187,085 |
|
||
Share premium |
|
3,577,640 |
- |
3,577,640 |
|
||
Other reserves |
|
134,709 |
93,151 |
98,559 |
|
||
Accumulated deficit |
|
(992,799) |
(233,564) |
(649,755) |
|
||
Total equity |
|
3,906,635 |
253,635 |
4,213,529 |
|
||
Liabilities |
|
|
|
|
|
||
Non-current liabilities |
|
|
|
|
|
||
Borrowings |
|
- |
313,003 |
- |
|
||
Total non-current liabilities |
|
- |
313,003 |
- |
|
||
Current liabilities |
|
|
|
|
|
||
Trade and other payables |
|
107,562 |
91,186 |
118,660 |
|
||
Total current liabilities |
|
107,562 |
91,186 |
118,660 |
|
||
Total liabilities |
|
107,562 |
404,189 |
118,660 |
|
||
Total equity and liabilities |
|
4,014,197 |
657,824 |
4,332,189 |
|
||
|
|
|
|
|
|
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Statement of Cash Flows
For the 6 months ended 31 December 2017
|
|
|
6 months to |
6 months to |
12 months to |
|
|
|
|
Unaudited |
Audited |
Audited |
|
|
|
|
£ |
£ |
£ |
|
Cash flows from operating activities |
|
|
|
|
||
Loss before tax for the period |
(386,523) |
(254,990) |
(688,239) |
|
||
Convertible loan interest paid as equity |
- |
6,154 |
15,540 |
|
||
Share option expenses |
36,150 |
- |
98,559 |
|
||
(Increase) / decrease in trade and other receivables |
115,377 |
(42,197) |
(120,582) |
|
||
Increase / (decrease) in trade and other payables |
(11,098) |
57,545 |
85,019 |
|
||
Net cash used in operating activities |
(246,094) |
(233,488) |
(609,703) |
|
||
Cash flows from investing activities |
|
|
|
|
||
Payments for intangible assets |
(27,333) |
(25,999) |
(79,198) |
|
||
Net cash used in investing activities |
(27,333) |
(25,999) |
(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 |
400,000 |
|
||
Net cash generated by financing activities |
- |
400,000 |
4,355,137 |
|
||
Net (decrease) / increase in cash and cash equivalents |
(273,427) |
140,513 |
3,666,236 |
|
||
|
|
|
|
|
|
|
Cash and cash equivalents at the beginning of the period |
3,922,903 |
256,667 |
256,667 |
|
||
Cash and cash equivalents at the end of the period |
3,649,476 |
397,180 |
3,922,903 |
|
||
|
|
|
|
|
|
|
|
|
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Statement of Changes in Equity
For the 6 months ended 31 December 2017
|
|
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Share capital |
Share premium |
Other reserves |
Retained earnings |
Total |
|
|
|
|
£ |
£ |
£ |
£ |
£ |
|
|
|
|
|
|
|
|
|
|
As at 1 Jul 2016 |
1,000 |
393,048 |
- |
(4,201) |
389,847 |
|
||
Loss for the period |
- |
- |
- |
(229,363) |
(229,363) |
|
||
Issue of shares |
393,048 |
(393,048) |
- |
- |
- |
|
||
Costs of share issue |
- |
- |
- |
- |
- |
|
||
Issue of convertible loan notes |
- |
- |
93,151 |
- |
93,151 |
|
||
Conversion of convertible loan notes |
- |
- |
- |
- |
- |
|
||
Share-based payments |
- |
- |
- |
- |
- |
|
||
As at 31 Dec 2016 |
394,048 |
- |
93,151 |
(233,564) |
253,635 |
|
||
|
|
|
|
|
|
|
|
|
As at 1 Jan 2017 |
394,048 |
- |
93,151 |
(233,564) |
253,635 |
|
||
Loss for the period |
- |
- |
- |
(416,191) |
(416,191) |
|
||
Issue of shares |
500,000 |
4,000,000 |
- |
- |
4,500,000 |
|
||
Costs of share issue |
- |
(544,863) |
- |
- |
(544,863) |
|
||
Issue of convertible loan notes |
- |
- |
- |
- |
- |
|
||
Conversion of convertible loan notes |
293,037 |
122,503 |
(93,151) |
- |
322,389 |
|
||
Share-based payments |
- |
- |
98,559 |
- |
98,559 |
|
||
As at 30 Jun 2017 |
1,187,085 |
3,577,640 |
98,559 |
(649,755) |
4,213,529 |
|
||
|
|
|
|
|
|
|
|
|
As at 1 Jul 2017 |
1,187,085 |
3,577,640 |
98,559 |
(649,755) |
4,213,529 |
|
||
Loss for the period |
- |
- |
- |
(343,044) |
(343,044) |
|
||
Issue of shares |
- |
- |
- |
- |
- |
|
||
Costs of share issue |
- |
- |
- |
- |
- |
|
||
Issue of convertible loan notes |
- |
- |
- |
- |
- |
|
||
Conversion of convertible loan notes |
- |
- |
- |
- |
- |
|
||
Share-based payments |
- |
- |
36,150 |
- |
36,150 |
|
||
As at 31 Dec 2017 |
1,187,085 |
3,577,640 |
134,709 |
(992,799) |
3,906,635 |
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|
|
|
|
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Share capital is the amount subscribed for shares at nominal value. |
|
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Share premium is the amount subscribed for share capital in excess of nominal value. |
|
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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 |
|
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Retained earnings represents accumulated profit or losses to date. |
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Notes to the half yearly report
1. General information
SkinBioTherapeutics plc 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 15 Silk House, Park Green, Macclesfield, SK11 7QJ.
The principal activity of the Company is the development of technology to protect, manage and restore skin utilising proteins found in the human microbiota.
The financial information set out in this half yearly report does not constitute statutory accounts as defined in Section 434 of the Companies Act 2006. The statutory financial statements for the year ended 30 June 2017, prepared under International Financial Reporting Standards ("IFRS"), have been filed with the Registrar of Companies. The auditor's report on those financial statements was unqualified and did not contain statements under Sections 498(2) and 498 (3) of the Companies Act 2006.
Copies of the annual statutory accounts and the half yearly report can be found on the Company's website at http://www.skinbiotherapeutics.com/.
2. Significant accounting policies and basis of preparation
2.1 Statement of compliance
This half yearly report has been prepared using the historical cost convention, on a going concern basis and in accordance with International Financial Reporting Standards ("IFRS") as adopted by the European Union, IFRS Interpretations Committee (IFRIC) and the Companies Act 2006 applicable to companies reporting under IFRS, using accounting policies which are consistent with those set out in the financial statements for the year ended 30 June 2017.
2.2 Application of new and revised International Financial Reporting Standards (IFRSs)
There are no IFRSs or IFRIC interpretations that are effective for the first time in this financial period that would be expected to have a material impact on the Company.
3. Segmental reporting
The Company has one reportable segment, namely the research and development of the Skinbiotix technology, all within the United Kingdom.
Notes to the half yearly report
4. |
Taxation |
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Income taxes recognised in profit or loss |
|
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6 months to |
6 months to |
12 months to |
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||||||||||||
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|
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£ |
£ |
£ |
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||||||||
Current tax |
|
|
|
|
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||||||||||
R&D tax credit |
|
|
|
43,479 |
25,627 |
42,685 |
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Tax credit for the period |
|
|
|
43,479 |
25,627 |
42,685 |
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5. |
Share capital |
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Issued share capital comprises |
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31 Dec 2017 |
31 Dec 2016 |
30 Jun 2017 |
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£ |
£ |
£ |
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118,708,494 ordinary shares of £0.01 each |
|
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1,187,085 |
394,048 |
1,187,085 |
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(31 Dec 2016 - 39,404,800 ordinary shares of £0.01 each)
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6. |
Loss per share |
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6 months to |
6 months to |
12 months to |
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||||||||
|
|
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|
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£ |
£ |
£ |
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Basic and diluted loss per share |
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Loss after tax (£) |
|
|
|
(343,044) |
(229,363) |
(645,554) |
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Weighted average number of shares |
|
|
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118,708,494 |
39,404,800 |
58,307,324 |
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Basic and diluted loss per share (pence) |
|
|
(0.29) |
(0.58) |
(1.11) |
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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.
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7. |
Events after the reporting date |
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The Company has evaluated all events and transactions that occurred after 31 December 2017 up to the date of signing of the financial statements. |
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