FOR IMMEDIATE RELEASE |
|
("
INTERIM RESULTS ANNOUNCEMENT
for the six months ended
Key Highlights
· Lupuzor™: is the Company's lead program for the potential breakthrough compound for Lupus a potential life threatening auto-immune disease
§ Total 11 sites active in US with 70 patients
§ Five European countries with 81 Lupus patients taking part in the trial:
§ One
· Most recent update on progress of Lupuzor™ trial announced on
· Top line results on track to report in Q1 2018
· As announced on
·
·
· Stable financial performance over the Period, in line with market expectations
o Net assets of
o Loss for the Period of
§ Research and Development expenses of
o Basic and diluted loss per share of 2.34p (H1 2016: 3.35p)
· New employee share option plan implemented in
· 'Investor' Event on
o
· New
Commenting on the Interims and outlook
"Ensuring that our pivotal Phase III Lupuzor™ trial progresses on track remains a key focus for
"We recently announced that all patients in the study have now passed the six months stage, with over 26% of patients having now completed the full 12 months. With a continued robust safety record, we are looking forward with confidence and planning for a successful outcome of the study with all patients completing the treatment protocol in the coming months and to reporting top-line results in Q1 2018.
"Having successfully completed a
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014. ("MAR")
For further information please contact:
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+ 44 (0) 20 7152 4080 |
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|
Dr |
|
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+ 44 (0) 7721 413496 |
|
|
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+44 (0) 20 3861 6625 |
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Chairman's Statement
INTERIM HIGHLIGHTS
The first half of 2017 saw the continued progression of our lead program LupuzorTM, for the treatment of Lupus, through significant milestones in its pivotal Phase III trial. The most recent update to the trial as announced on
· all patients in the study have passed the 6 months stage, and
· 52 patients (26%) have completed the full 12 months of the study
Importantly there continues to be a robust safety record which remains consistent with Lupuzor™'s product profile as shown in its previous Phase IIb study.
As announced on
We were also pleased to have successfully completed an oversubscribed
Lupuzor™ Phase III Trial - Progress through H1 2017
Lupuzor™ received approval from the
The Phase III trial is a double-blind, randomised, placebo-controlled trial. The study involves patients being dosed for one year, receiving 0.2mg once every month subcutaneously. Significant progress was made toward completion of the trial. 293 patients were screened illustrating the demand from physicians for a new, safe and effective treatment for Lupus. Of these, the required 200 patients have been successfully recruited and randomised (dosed). Patients are participating in the trial in 7 countries across 28 sites.
In
Lupus - Opportunity
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 for Lupuzor™ which could include: a global licensing deal;
Pipeline Overview
LupuzorTM - Forigerimod / P140 Auto-Immune Platform
Lupuzor™, is also known by its chemical name 'Forigerimod' or P140.
An important patent has been granted in key countries (
Additionally, a new patent has been filed (co-owned with CNRS) to cover non-autoimmune indications. Further preclinical work continues at the CNRS with the objective of further indications moving into the clinic in due course.
Nucant Platform
Our Cancer Nucant program, IPP-204106, is focused on combination therapy approaches and
The Group has also been awarded grants to investigate its use in age-related macular degeneration, diabetic retinopathy and other ophthalmological indications. The preliminary results are very encouraging and the product could be ready for clinical assessment provided sufficient funding is secured.
Peptide Platform
Investor Symposium on
· Lupuzor™ / P140 : Auto Immune Diseases
· Nucants : Oncology / Opthamology
· Peptides : Metabolic Disorders
The video of the presentation can be seen on http://www.immupharma.co.uk/media/events.
Financial Review
Operating loss for the Period was
Given the stage of
Current Activities and Outlook
The Board are excited by
The Board would like to thank its shareholders, both longstanding and those who participated in the more recent fundraisings, for their support as well as its staff, corporate and scientific advisers including
Chairman
CONSOLIDATED INCOME STATEMENT
FOR THE PERIOD ENDED 30 JUNE 2017
|
Note |
Unaudited 6 months ended |
|
Audited Year ended 31 December 2016 |
|
Unaudited 6 months ended |
|
|
£ |
|
£ |
|
£ |
Continuing operations |
|
|
|
|
|
|
Revenue |
1 |
86,504 |
|
164,784 |
|
2,924 |
Research and development expenses |
|
(2,345,815) |
|
(5,267,087) |
|
(2,508,578) |
Administrative expenses |
|
(927,640) |
|
(1,486,858) |
|
(733,893) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(3,186,951) |
|
(6,589,161) |
|
(3,239,547) |
|
|
|
|
|
|
|
Finance costs |
|
(375) |
|
(23,085) |
|
(501,671) |
Finance income |
|
153,915 |
|
297,809 |
|
362 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before taxation |
|
(3,033,411) |
|
(6,314,437) |
|
(3,740,856) |
|
|
|
|
|
|
|
Tax |
|
(485) |
|
990,421 |
|
(362) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the period |
|
(3,033,896) |
|
(5,324,016) |
|
(3,741,218) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Attributable to: |
|
|
|
|
|
|
Equity holders of the parent company |
|
(3,033,896) |
|
(5,324,016) |
|
(3,741,218) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per ordinary share |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
2 |
(2.34)p |
|
(4.54)p |
|
(3.35)p |
|
|
|
|
|
|
|
Diluted |
2 |
(2.34)p |
|
(4.54)p |
|
(3.35)p |
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE PERIOD ENDED 30 JUNE 2017
|
Unaudited 6 months ended 30 June 2017 |
|
Audited Year ended 31 December 2016 |
|
Unaudited 6 months ended 30 June 2016 |
|
£ |
|
£ |
|
£ |
|
|
|
|
|
|
Loss for the financial period |
(3,033,896) |
|
(5,324,016) |
|
(3,741,218) |
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income |
|
|
|
|
|
Items that may be reclassified subsequently to profit or loss:
|
|
|
|
|
|
Exchange differences on translation of foreign operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total items that may be reclassified subsequently to profit or loss |
(56,133) |
|
317,177 |
|
224,692 |
|
|
|
|
|
|
Other comprehensive loss for the period |
(56,133) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the period |
(3,090,029) |
|
(5,006,839) |
|
(3,516,526) |
|
|
|
|
|
|
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 30 JUNE 2017
|
Note |
Unaudited 30 June 2017 |
|
Audited 31 December 2016 |
|
Unaudited |
|
|
|
£ |
|
£ |
|
£ |
|
Non-current assets |
|
|
|
|
|
|
|
Intangible assets |
|
497,585 |
|
511,088 |
|
522,668 |
|
Property, plant and equipment |
|
192,573 |
|
231,901 |
|
269,435 |
|
Derivative financial asset |
4 |
- |
|
- |
|
587,054 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total non-current assets |
|
690,158 |
|
742,989 |
|
1,379,157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
Trade and other receivables |
|
2,439,143 |
|
2,535,265 |
|
2,724,631 |
|
Derivative financial asset |
4 |
943,861 |
|
1,554,866 |
|
2,556,565 |
|
Cash and cash equivalents |
|
3,131,595 |
|
1,876,718 |
|
661,009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
6,514,599 |
|
5,966,849 |
|
5,942,205 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
Financial liabilities - borrowings |
|
119,430 |
|
143,109 |
|
134,435 |
|
Trade and other payables |
|
473,867 |
|
786,191 |
|
767,163 |
|
Provisions |
|
33,162 |
|
15,050 |
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
626,459 |
|
944,350 |
|
901,598 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net current assets |
|
5,888,140 |
|
5,022,499 |
|
5,040,607 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities |
|
|
|
|
|
|
|
Financial liabilities - borrowings |
|
170,232 |
|
219,445 |
|
263,664 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net assets |
|
6,408,066 |
|
5,546,043 |
|
6,156,100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY |
|
|
|
|
|
|
|
Ordinary shares |
|
13,252,298 |
|
12,463,836 |
|
12,178,122 |
|
Share premium |
|
18,728,519 |
|
15,678,054 |
|
15,148,894 |
|
Merger reserve |
|
106,148 |
|
106,148 |
|
106,148 |
|
Other reserves |
|
(3,316,753) |
|
(3,373,745) |
|
(3,531,612) |
|
Retained earnings |
|
(22,362,146) |
|
(19,328,250) |
|
(17,745,452) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total equity |
|
6,408,066 |
|
5,546,043 |
|
6,156,100 |
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE PERIOD ENDED 30 JUNE 2017
|
|
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
|
8,862,246 |
|
10,490,920 |
|
106,148 |
|
(3,541,203) |
|
(1,926,850) |
|
1,703,380 |
|
(14,004,234) |
|
1,690,407 |
|
Loss for the financial period |
- |
|
- |
|
- |
|
- |
|
- |
|
- |
|
(3,741,218) |
|
(3,741,218) |
|
Exchange differences on translation of foreign operations |
- |
|
- |
|
- |
|
- |
|
224,692 |
|
- |
|
- |
|
224,692 |
|
New issue of equity capital |
3,315,876 |
|
5,305,401 |
|
- |
|
- |
|
- |
|
- |
|
- |
|
8,621,277 |
|
Cost of new issue of equity capital |
- |
|
(647,427) |
|
- |
|
- |
|
- |
|
- |
|
- |
|
(647,427) |
|
Share based payments |
- |
|
- |
|
- |
|
- |
|
- |
|
8,369 |
|
- |
|
8,369 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At |
12,178,122 |
|
15,148,894 |
|
106,148 |
|
(3,541,203) |
|
(1,702,158) |
|
1,711,749 |
|
(17,745,452) |
|
6,156,100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At |
8,862,246 |
|
10,490,920 |
|
106,148 |
|
(3,541,203) |
|
(1,926,850) |
|
1,703,380 |
|
(14,004,234) |
|
1,690,407 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the financial year |
- |
|
- |
|
- |
|
- |
|
- |
|
- |
|
(5,324,016) |
|
(5,324,016) |
|
Exchange differences on translation of foreign operations |
- |
|
- |
|
- |
|
- |
|
317,177 |
|
- |
|
- |
|
317,177 |
|
New issue of equity capital |
3,601,590 |
|
5,798,410 |
|
- |
|
- |
|
- |
|
- |
|
- |
|
9,400,000 |
|
Cost of new issue of equity capital |
- |
|
(611,276) |
|
- |
|
- |
|
- |
|
- |
|
- |
|
(611,276) |
|
Share based payment |
- |
|
- |
|
- |
|
- |
|
- |
|
73,751 |
|
- |
|
73,751 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At |
12,463,836 |
|
15,678,054 |
|
106,148 |
|
(3,541,203) |
|
(1,609,673) |
|
1,777,131 |
|
(19,328,250) |
|
5,546,043 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the financial period |
- |
|
- |
|
- |
|
- |
|
- |
|
- |
|
(3,033,896) |
|
(3,033,896) |
|
Exchange differences on translation of foreign operations |
- |
|
- |
|
- |
|
- |
|
(56,133) |
|
- |
|
- |
|
(56,133) |
|
New issue of equity capital |
788,462 |
|
3,311,542 |
|
- |
|
- |
|
- |
|
- |
|
- |
|
4,100,004 |
|
Cost of new issue of equity capital |
- |
|
(261,077) |
|
- |
|
- |
|
- |
|
- |
|
- |
|
(261,077) |
|
Share based payment |
- |
|
- |
|
- |
|
- |
|
- |
|
113,125 |
|
- |
|
113,125 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At |
13,252,298 |
|
18,728,519 |
|
106,148 |
|
(3,541,203) |
|
(1,665,806) |
|
1,890,256 |
|
(22,362,146) |
|
6,408,066 |
|
Attributable to:- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity holders of the parent company |
13,252,298 |
|
18,728,519 |
|
106,148 |
|
(3,541,203) |
|
(1,665,806) |
|
1,890,256 |
|
(22,362,146) |
|
6,408,066 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENT OF CASHFLOWS
FOR THE PERIOD ENDED 30 JUNE 2017
|
Note |
Unaudited 6 months ended 30 June 2017 |
|
Audited Year ended 31 December 2016 |
|
Unaudited 6 months ended 30 June 2016 (Restated) |
|
|
|
|
£ |
|
£ |
|
£ |
|
|
Cash flows from operating activities |
|
|
|
|
|
|
|
|
Cash used in operations |
3 |
(3,200,329) |
|
(7,191,318) |
|
(4,484,973) |
|
|
Tax |
|
6,680 |
|
707,135 |
|
5,944 |
|
|
Interest paid |
|
(375) |
|
(1,917) |
|
(496) |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
(3,194,024) |
|
(6,486,100) |
|
(4,479,525) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
|
|
|
Purchase of property, plant and equipment |
|
(1,595) |
|
(4,731) |
|
(3,404) |
|
|
Interest received |
|
170 |
|
1,722 |
|
362 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
(1,425) |
|
(3,009) |
|
(3,042) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
|
|
(Decrease) in bank overdraft |
|
(138) |
|
(1,091) |
|
(1,199) |
|
|
Loan repayments |
|
(80,447) |
|
(143,482) |
|
(93,579) |
|
|
Gross proceeds from issue of new share capital |
|
4,100,004 |
|
9,400,000 |
|
8,621,277 |
|
|
Settlements from sharing agreement |
4 |
682,360 |
|
2,690,451 |
|
309,650 |
|
|
Share capital issue costs |
|
(261,077) |
|
(611,276) |
|
(647,427) |
|
|
Funds deferred per sharing agreement |
4 |
- |
|
(3,949,230) |
|
(3,949,230) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash generated from /(used in) financing activities |
|
4,440,702 |
|
7,385,372 |
|
4,239,492 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase/(decrease) in cash and cash equivalents
|
|
1,245,253 |
|
896,263 |
|
(243,075) |
|
|
Cash and cash equivalents at start of period |
|
1,876,718 |
|
833,388 |
|
833,388 |
|
|
Effects of exchange rates on cash and cash equivalents |
9,624 |
|
(147,067) |
|
70,696 |
|
||
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
3,131,595 |
|
1,876,718 |
|
661,009 |
|
|
|
|
|
|
|
|
|
|
|
NOTES TO THE CONSOLIDATED INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2017
1 ACCOUNTING POLICIES
Basis of preparation
The interim financial information in this report has been prepared using accounting policies consistent with IFRS as adopted by the
The accounting policies applied are consistent with those that were applied to the financial statements for the year ending 31 December 2016.
Non-Statutory accounts
The financial information set out in this interim report does not constitute the Group's statutory accounts, within the meaning of Section 434 of the Companies Act 2006. The statutory accounts for the year ended 31 December 2016 have been filed with Registrar of Companies. The auditors reported on those accounts; their report was unqualified, did not contain a statement under either Section 498 (2) or Section 498 (3) of the Companies Act 2006 and did not include references to any matters to which the auditor drew attention by way of emphasis. The financial information for the 6 months ended 30 June 2017 and 30 June 2016 is unaudited.
Copies of this statement will be available on the Company's website - www.immupharma.com.
NOTES TO THE CONSOLIDATED INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2017
(Continued)
2 LOSS PER SHARE
|
Unaudited |
|
Audited Year ended 31 December 2016 |
|
Unaudited |
|
£ |
|
£ |
|
£ |
|
|
|
|
|
|
Loss |
|
|
|
|
|
Loss for the purposes of basic and diluted loss per share being net loss attributable to equity shareholders |
(3,033,896) |
|
|
|
(3,741,218) |
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares |
|
|
|
|
|
Weighted average number of ordinary shares for the purposes of basic loss per share |
129,517,245 |
|
117,340,467 |
|
111,578,525 |
|
|
|
|
|
|
|
|
|
|
|
|
Basic loss per share |
(2.34)p |
|
(4.54)p |
|
(3.35)p |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted loss per share |
(2.34)p |
|
(4.54)p |
|
(3.35)p |
|
|
|
|
|
|
|
|
|
|
|
|
There is no difference between basic loss per share and diluted loss per share as the share options and warrants are anti-dilutive.
The group has granted share options in respect of shares to be issued.
NOTES TO THE CONSOLIDATED INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2017
(Continued)
3 |
CASH USED IN OPERATIONS |
|
|||||||||
|
|
|
Unaudited 6 months ended 30 June 2017 |
|
Audited Year ended 31 December 2016 |
|
Unaudited 6 months ended 30 June 2016 |
|
|||
|
|
|
£ |
|
£ |
|
£ |
|
|||
|
|
|
|
|
|
|
|
|
|||
|
Operating loss |
|
(3,186,951) |
|
(6,589,161) |
|
(3,239,547) |
|
|||
|
Depreciation & amortisation |
61,954 |
|
121,337 |
|
59,058 |
|
||||
|
Share based payments |
113,125 |
|
73,751 |
|
8,369 |
|
||||
|
(Increase)/decrease in trade & other receivables |
|
34,004 |
|
(387,713) |
|
(915,358) |
|
|||
|
(Decrease) in trade & other payables |
|
(322,963) |
|
(403,414) |
|
(392,281) |
|
|||
|
Increase in provisions |
|
18,112 |
|
15,050 |
|
- |
|
|||
|
Gain/(loss) on foreign exchange |
|
82,390 |
|
(21,168) |
|
(5,214) |
|
|||
|
|
|
|
|
|
|
|
|
|||
|
Cash used in operations |
|
(3,200,329) |
|
(7,191,318) |
|
(4,484,973) |
|
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|
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|
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4
|
DERIVATIVE FINANCIAL ASSET
In February 2016, as part of a placing that raised, in aggregate, £8.4 million (before expenses) from new and existing shareholders, the Company issued 17,021,277 new ordinary shares to Lanstead Capital LP at a price of 26p per share for £4.4 million. All of the shares were allotted to Lanstead with full voting rights at that date. The Company simultaneously entered into a sharing agreement with Lanstead with a reference price of 34.6667p per share. The sharing agreement is for an 18 month period. The actual consideration is variable depending upon the Company's share price. The agreement is treated as a derivative financial asset and valued at fair value through the income statement with reference to the Company's share price.
Of the subscription proceeds of £4.4 million received from Lanstead, £3.76 million (85%) was invested by the Company in the sharing agreement and will be received in monthly instalments over the life of the agreement. The remaining £663,820 (15%) was available for immediate working capital purposes.
The Company also issued, in aggregate, a further 851,064 new ordinary shares to Lanstead as a value payment in connection with the agreement.
At the end of the accounting period the amount receivable is restated to fair value based upon the share price of the Company at that date. Any change in the fair value of the derivative financial asset is reflected in the income statement.
|
5 |
SUBSEQUENT EVENTS |
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|
|
There were no events subsequent to 30 June 2017.
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This information is provided by RNS