FOR IMMEDIATE RELEASE |
4 May 2016 |
PRELIMINARY RESULTS
for the year ended
Key Highlights:
Lupuzor™
· Pivotal Phase III clinical trial for Lupuzor™, the Company's lead programme for the potential breakthrough compound for Lupus, is progressing, in conjunction with
· Phase III trial is fully funded following
· An Investigators Meeting was held in
· First US sites commenced dosing Lupus patients in
Wider program developments
·
o A new patent has been filed outside of Lupus, which has the potential for Orphan Drug designation
· The Company's Cancer Nucant program, IPP-204106, demonstrated within its Phase I/IIa dose-finding adaptive study that the maximum tolerated dose was 9 mg/kg, which was the primary objective of the study. A number of options are under review to further progress this program
Further notable events
·
· Dr
· Prof.
· In February and
· Advance assurance received from HMRC for VCT and EIS qualifying status
Financial Summary
· Cash position as at
· Loss for the period of
· Basic and diluted loss per share of 4.40p (2014: 3.43p)
Announced Today: Prof.
· A number of key symposiums will be hosted during this two day event where
On outlook
"
The Board would like to thank its shareholders, both those longstanding and those who participated in the recent fundraising, for their support, as well as its staff, corporate and scientific advisors including
-Ends-
For further information please contact:
|
|
Chairman's Report
2015 was a year predominantly dedicated to the progress of our lead programme, Lupuzor™ (a breakthrough treatment for the auto-immune disease Lupus), into its pivotal Phase III trial and to initiating the strengthening of our financial position. We achieved both. Our first Lupus patients have been recruited in the
Lupuzor™: progress through 2015
In
Lupuzor™ received approval from the
Lupuzor™ Phase III Trial
A number of important operational and regulatory milestones were reached throughout 2015 in conjunction with our partner,
As background to the study, recruitment will occur in up to 45 investigator sites, 10 sites in
In
Lupuzor™ Investigators Meeting,
An integral milestone of the study was the 'Investigator Meeting' was held in
The event was jointly organised by
Lupus Market
There are an estimated five million people globally suffering from Lupus, with approximately 1.5 million patients in the US,
Lupuzor™ has the potential to be a novel specific first-line drug therapy for the treatment of Lupus by specifically modulating the immune system and halting disease progression in a substantial proportion of patients. Lupuzor™ has a unique mechanism of action that modulates the activity of CD4 T-cells which are involved in the cell-mediated immune response which leads to the Lupus disease. Lupuzor™, taken over the long term, as indicated in earlier stage clinical trials, has the potential to prevent the progression of Lupus rather than just treating its symptoms, with the rest of the immune system retaining the ability to work normally.
There will be a number of routes to market Lupuzor™ which are open for consideration upon receipt of approval by the
Pipeline Overview
Forigerimod / P140 Auto-Immune Platform
Lupuzor™, is also known by its chemical name 'Forigerimod' or P140.
A new patent has been filed (co-owned with CNRS) to cover other autoimmune indications, outside of Lupus, some of which have the potential for Orphan Drug designation. Further preclinical work continues with the objective of further indications moving into the clinic in due course.
Nucant Platform
The Company's Cancer Nucant program, IPP-204106, is focused on combination therapy approaches.
The Group has also been awarded grants to investigate its use in age-related macular degeneration, diabetic retinopathy and other ophthalmological indications.
Peptide Platform
Post-Period Review:
In February and
• Directors
•
• Aviva, our longstanding major institutional investor
• New institutions including
• Longstanding private client shareholders
As part of the fundraising exercise,
Board Changes
Awards
We were delighted to note that Prof.
Current Activities and Outlook
The Board continues to be excited by
The key milestone this year is the completion of the recruitment of the 200 Lupus patients, with top line results expected to be announced by the end of 2017.
The Board would like to thank its shareholders, both longstanding and those who participated in the recent fundraising, for their support as well as its staff, corporate and scientific advisors including
Non-Executive Chairman
Financial Review
2015 was a year focused on progressing our lead programme, LupuzorTM, in its pivotal Phase III trial, with our first Lupus patients recruited in the
The overall loss for the year ended
The Company has cash and cash equivalents as at
During February and
VCT & EIS Assurance
As part of the fundraising exercise,
Treasury Policy
The policy continues to be that surplus funds of the Group are held in interest-bearing bank accounts on short or medium maturities, until commitments to future expenditure are made, when adequate funds are released to enable future expenditure to be incurred. The Group's Treasury Policy and controls are straightforward and approved by the Board.
Financial Strategy
The overall strategy is to maintain a tight control over cash resources whilst enabling continued progress of the Company's pivotal Phase III Lupuzor™ trial through to top line results expected by the end of 2017 and the progression of its other earlier stage pipeline candidates where cash reserves permit.
Vice President, Operations and Finance
CONSOLIDATED INCOME STATEMENT
FOR THE YEAR ENDED 31 DECEMBER 2015
|
|
Year ended |
|
Year ended |
|
|
|
£ |
|
£ |
|
Continuing operations |
|
|
|
|
|
Revenue |
|
76,407 |
|
184,815 |
|
Research and development expenses |
|
(2,993,717) |
|
(2,269,349) |
|
Administrative expenses |
|
(1,645,799) |
|
(1,340,366) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(4,563,109) |
|
(3,424,900) |
|
|
|
|
|
|
|
Finance costs |
|
(1,208) |
|
(14,195) |
|
Finance income |
|
15,843 |
|
98,936 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before taxation |
|
(4,548,474) |
|
(3,340,159) |
|
|
|
|
|
|
|
Tax |
|
650,977 |
|
468,679 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the year |
|
(3,897,497) |
|
(2,871,480) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Attributable to: |
|
|
|
|
|
Equity holders of the parent company |
|
(3,897,497) |
|
(2,871,480) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per ordinary share |
|
|
|
|
|
|
|
|
|
|
|
Basic |
2 |
(4.40p) |
|
(3.43p) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
2 |
(4.40p) |
|
(3.43p) |
|
|
|
|
|
|
|
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE YEAR ENDED 31 DECEMBER 2015
|
Year ended |
|
Year ended |
|
|
£ |
|
£ |
|
|
|
|
|
|
Loss for the financial year |
(3,897,497) |
|
(2,871,480) |
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income |
|
|
|
|
Items that may be reclassified subsequently to profit or loss: |
|
|
|
|
|
|
|
|
|
Exchange differences on translation of foreign operations |
(117,478) |
|
(230,357) |
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive (loss)/income for the year, net of tax |
(117,478) |
|
(230,357) |
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the year |
(4,014,975) |
|
(3,101,837) |
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 31 DECEMBER 2015
|
|
|
|
|
|
|
|
£ |
|
£ |
|
|
|
|
|
|
|
Non-current assets |
|
|
|
|
|
Intangible assets |
|
522,462 |
|
560,537 |
|
Property, plant and equipment |
|
280,127 |
|
366,363 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total non-current assets |
|
802,589 |
|
926,900 |
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
Trade and other receivables |
|
1,577,091 |
|
721,410 |
|
Cash and cash equivalents |
|
833,388 |
|
5,424,033 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
2,410,479 |
|
6,145,443 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Financial liabilities - borrowings |
|
163,070 |
|
417,852 |
|
Trade and other payables |
|
1,078,640 |
|
549,652 |
|
Provisions |
|
- |
|
23,468 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
1,241,710 |
|
990,972 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net current assets |
|
1,168,769 |
|
5,154,471 |
|
|
|
|
|
|
|
Non-current liabilities |
|
|
|
|
|
Financial liabilities - borrowings |
|
280,951 |
|
375,989 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net assets |
|
1,690,407 |
|
5,705,382 |
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY |
|
|
|
|
|
Ordinary shares |
|
8,862,246 |
|
8,862,246 |
|
Share premium |
|
10,490,920 |
|
10,490,920 |
|
Merger reserve |
|
106,148 |
|
106,148 |
|
Other reserves |
|
(3,764,673) |
|
(3,647,195) |
|
Retained earnings |
|
(14,004,234) |
|
(10,106,737) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total equity |
|
1,690,407 |
|
5,705,382 |
|
|
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE YEAR ENDED 31 DECEMBER 2015
|
|
Share capital |
|
Share premium |
|
Merger reserve |
|
Other reserves - Acquisition reserve |
|
Other reserves - Translation reserve |
|
Other reserves- Equity shares to be issued |
|
Retained earnings |
|
Total equity |
|
|
£ |
|
£ |
|
£ |
|
£ |
|
£ |
|
£ |
|
£ |
|
£ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At |
8,228,246 |
|
7,764,720 |
|
106,148 |
|
(3,541,203) |
|
(1,579,015) |
|
1,660,105 |
|
(7,235,257) |
|
5,403,744 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the financial year
|
- |
|
- |
|
-
|
|
- |
|
- |
|
- |
|
(2,871,480) |
|
(2,871,480) |
|
Exchange differences on translation of foreign operations
|
- |
|
- |
|
- |
|
- |
|
(230,357) |
|
- |
|
- |
|
(230,357) |
|
Share based payments
|
- |
|
- |
|
-
|
|
- |
|
- |
|
43,275 |
|
- |
|
43,275
|
|
New issue of equity capital |
634,000 |
|
2,726,200 |
|
-
|
|
-
|
|
-
|
|
- |
|
- |
|
3,360,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At |
8,862,246 |
|
10,490,920 |
|
106,148 |
|
(3,541,203) |
|
(1,809,372) |
|
1,703,380 |
|
(10,106,737) |
|
5,705,382 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the financial year
|
- |
|
- |
|
- |
|
- |
|
- |
|
- |
|
(3,897,497) |
|
(3,897,497) |
|
Exchange differences on translation of foreign operations
|
- |
|
- |
|
- |
|
- |
|
(117,478) |
|
- |
|
- |
|
(117,478) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At |
8,862,246 |
|
10,490,920 |
|
106,148 |
|
(3,541,203) |
|
(1,926,850) |
|
1,703,380 |
|
(14,004,234) |
|
1,690,407 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Attributable to:- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity holders of the parent company |
8,862,246 |
|
10,490,920 |
|
106,148 |
|
(3,541,203) |
|
(1,926,850) |
|
1,703,380 |
|
(14,004,234) |
|
1,690,407 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE YEAR ENDED 31 DECEMBER 2015
|
Notes |
|
Year ended |
|
Year ended |
|
|
|
|
£ |
|
£ |
|
|
|
|
|
|
|
|
Cash flows from operating activities |
|
|
|
|
|
|
Cash used in operations |
3 |
|
(4,582,411) |
|
(3,231,366) |
|
Tax received |
|
|
435,261 |
|
754,996 |
|
Interest paid |
|
|
(1,208) |
|
(14,195) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(4,148,358) |
|
(2,490,565) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
|
Purchase of property, plant and equipment |
|
|
(20,761) |
|
(342,275) |
|
Purchase of intangibles |
|
|
- |
|
(5,656) |
|
Interest received |
|
|
11,541 |
|
72,759 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(9,220) |
|
(275,172) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
Increase/(decrease) in bank overdraft |
|
|
879 |
|
(146) |
|
Loan repayments |
|
|
(333,135) |
|
(395,326) |
|
Loan received |
|
|
22,130 |
|
- |
|
Net proceeds from issue of new share capital |
|
|
- |
|
3,360,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in)/generated from financing activities |
|
|
(310,126) |
|
2,964,728 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease)/increase in cash and cash equivalents |
|
|
(4,467,704) |
|
198,991 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of year |
|
|
5,424,033 |
|
5,396,296 |
|
|
|
|
|
|
|
|
Effects of exchange rates on cash and cash equivalents |
|
|
(122,941) |
|
(171,254) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of year |
|
|
833,388 |
|
5,424,033 |
|
|
|
|
|
|
|
|
NOTES
1 BASIS OF PREPARATION
The financial information set out in this announcement does not comprise the Group's statutory accounts as defined in section 434 of the Companies Act 2006 for the year ended
The financial information has been extracted from the statutory accounts for the years ended
The Group's statutory accounts for the year ended
The accounting policies are consistent with those applied in the preparation of the interim results for the period ended
The financial information is for the year ended
The Group's statutory accounts incorporate the financial statements of
NOTES (continued)
2 |
LOSS PER SHARE - Group |
Year ended |
|
Year ended |
|
|
£ |
|
£ |
|
Loss |
|
|
|
|
Loss for the purposes of basic loss per share being net loss after tax attributable to equity shareholders |
(3,897,497) |
|
(2,871,480) |
|
|
|
|
|
|
|
|
|
|
|
Number of shares |
|
|
|
|
Weighted average number of ordinary shares for the purposes of basic earnings per share |
88,622,463 |
|
83,602,573 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic loss per share |
(4.40)p |
|
(3.43)p |
|
|
|
|
|
|
|
|
|
|
|
Diluted loss per share |
(4.40)p |
|
(3.43)p |
|
|
|
|
|
|
|
|
|
|
|
There is no difference between basic loss per share and diluted loss per share as the share options are anti-dilutive. |
NOTES (continued)
3 |
|
||||
|
|
Group |
|
Group |
|
|
|
£ |
|
£ |
|
|
Operating loss |
(4,563,109) |
|
(3,424,900) |
|
|
Depreciation and amortisation |
121,748 |
|
99,166 |
|
|
Share-based payments |
- |
|
43,275 |
|
|
(Increase)/decrease in trade and other receivables |
(674,440) |
|
172,445 |
|
|
Increase/(decrease) in trade and other payables |
552,556 |
|
(114,397) |
|
|
Decrease in provisions |
(23,468) |
|
(33,132) |
|
|
Gain/(loss) on foreign exchange |
4,302 |
|
26,177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash used in operations |
(4,582,411) |
|
(3,231,366) |
|
|
|
|
|
|
|
|
|
NOTES (continued)
4 SUBSEQUENT EVENTS
In February and March of 2016
Lanstead Subscription Agreement
17,021,277 new Ordinary Shares were issued to Lanstead at a price of 26p per Ordinary Share for an aggregate subscription price of
Lanstead Sharing Agreement
As part of the Subscription, the Company has entered into the Sharing Agreement, pursuant to which
The Sharing Agreement provides that the Company will receive 18 equal monthly settlement amounts as measured against a benchmark share price of
If the measured share price (the "Measured Price"), calculated as the average volume weighted share price of the Company's Ordinary Shares over an agreed period prior to the monthly settlement date, exceeds the Benchmark Price, the Company will receive more than 100 per cent. of that monthly settlement due on a pro rata basis according to the excess of the Measured Price over the Benchmark Price. There is no upper limit placed on the additional proceeds receivable by the Company as part of the monthly settlements and the amount available in subsequent months is not affected. Should the Measured Price be below the Benchmark Price, the Company will receive less than 100 per cent of the monthly settlement calculated on a pro rata basis and the Company will not be entitled to receive the shortfall at any later date.
For example, if on a monthly settlement date the calculated Measured Price exceeds the Benchmark Price by 10 per cent., the settlement on that monthly settlement date will be 110 per cent. of the amount due from Lanstead on that date. If on the monthly settlement date the calculated Measured Price is below the Benchmark Price by 10 per cent., the settlement on the monthly settlement date will be 90 per cent. of the amount due on that date. Each settlement as so calculated will be in final settlement of Lanstead's obligation on that settlement date.
Assuming the Measured Price equals the Benchmark Price on the date of each and every monthly settlement,
This information is provided by RNS