("ImmuPharma" or the "Company")
FINAL RESULTS ANNOUNCEMENT
for the twelve months ended
Key Highlights (including post Period review)
· Lupuzor™: is the Company's lead program for the potential breakthrough compound for lupus a potential life threatening auto-immune disease
o Pivotal Phase III trial is progressing on track with development partner Simbec-Orion
§ Total 11 sites active in US with 70 patients
§ Five European countries with 81 lupus patients taking part in trial: Czech Republic, France, Germany, Hungary and Poland
§ One Mauritius site with 49 lupus patients included in trial
o Most recent update on progress of Lupuzor™ trial announced on
o Top line results anticipated in Q1 2018
· Prof Sylviane Muller, inventor of P140, held a number of key symposiums hosted in London,
o Prof Muller provided further evidence of the role the P140 molecule can take in the potential treatment of other autoimmune diseases, including those which have Orphan indications
· Three successful, value accretive fundraisings - to support Lupuzor™'s Phase III trial and working capital requirements
o
o
o
o All three fundraisings were supported by existing long term shareholders together with the addition of new blue chip institutions
o Advance assurance received from HMRC for VCT and EIS qualifying status
· Wider program developments
o A number of options are under review to further progress ImmuPharma's cancer Nucant program, IPP-204106 following a Phase I/IIa dose-finding adaptive study which showed that the maximum tolerated dose was 9 mg/kg, the primary objective of the study
o
o ImmuPharma and CNRS have filed a series of new co-owned patents controlling the Company's peptide platform technology URELIX, with Type II diabetes and NASH (Non-Alcoholic-Steato-Hepatitis) being the first therapeutic areas to be targeted. This technology allows inter alia outstanding properties in terms of duration of action.
·
· 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 4.54p (
· Prof. Sylviane Muller - Finalist for the European Inventor Award 2017: 'Invention' Category "Treating Lupus by Targeting T-cells"
§ Forthcoming 'Investor' Event on
o ImmuPharma will be hosting an Investor Presentation and luncheon immediately following the Company's Annual General Meeting, currently scheduled for Friday 30 June, in the City of London. Further details will be disclosed when ImmuPharma's Report and Accounts are posted to shareholders in the next week. Please contact Lisa Baderoon at lisa.baderoon@immupharma.com if you would like to attend this event.
Commenting on the statement and outlook Tim McCarthy, Chairman, said:
"We have achieved a number of significant milestones during this period including three successful and share price accretive fund raisings.
"We are delighted by the continued progress of our LupuzorTM Phase III study having recently announced that all 200 patients have passed the three month stage, 28 patients have passed the full 12 months of the study and over 80% of patients having had exposure to LupuzorTM for over six months, compared to our Phase IIb three month study, whilst still maintaining an excellent safety profile. We remain on track to report top line results in Q1 2018.
"The Board would like to thank its shareholders both long-standing and new for their support, as well as its staff, corporate and scientific advisors and the CNRS for their ongoing collaboration."
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014. ("MAR")
-Ends-
For further information please contact:
|
|
Chairman's Report
2016 was a year of significant progress for ImmuPharma. Our lead program, Lupuzor™, a potential breakthrough treatment for the auto-immune disease lupus, saw the dosing of the first patients in the US and Europe in the early part of the year. In December, we announced, on track, completion of the full 200 patients being recruited into the trial. During the year, we also successfully completed two fund raising rounds, generating a total of
Lupuzor™: progress through 2016
Following the finalisation of an agreement in 2015 to work together, Simbec-Orion, an international clinical research organisation, has been undertaking the crucial Phase III clinical trial for Lupuzor™. Simbec-Orion specialises in Rare & Orphan conditions and has previous direct experience in lupus trials. This is a pivotal study designed to demonstrate the safety and efficacy of Lupuzor™ and is the last step prior to filing for approval. In addition, following an approach from the government of Mauritius, we have added a further site for the Lupuzor™ Phase III clinical trial in Mauritius with the help of
Lupuzor™ received approval from the
Lupuzor™ Phase III Trial
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 the United States the trial has been approved by a major
In
Top line data is expected during Q1 2018. Progress of the trial can be seen at: www.clinicaltrials.gov (search term 'lupuzor').
Lupus Market
There are an estimated five million people globally suffering from lupus, with approximately 1.5 million patients in the US, Europe and Japan (Source:
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; ImmuPharma partnering with regional distributors, globally or an outright sale of Lupuzor™ or the Company. The prime objective of any strategy would be to maximise shareholder return.
Centre National de la Recherché Scientifique (CNRS)
ImmuPharma continues to have important collaboration arrangements with the Centre National de la Recherché Scientifique (CNRS), the
Pipeline Overview
Forigerimod / P140 Autoimmune Platform - LupuzorTM
Lupuzor™, is also known by its chemical name 'Forigerimod' or P140. ImmuPharma in conjunction with the CNRS are working hard on expanding the P140 auto immune pipeline, as demonstrated by Lupuzor™'s strong efficacy and safety profile and by its mechanism of action.
A new patent has been filed (co-owned with CNRS) to cover other auto immune 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
Our Cancer Nucant program, IPP-204106, is focused on combination therapy approaches. We previously announced that the Phase I/IIa dose-finding adaptive study where the Nucant was associated with chondroitin sulphate, demonstrated that the maximum tolerated dose was 9 mg/kg. This was the primary objective of the study. ImmuPharma is now reviewing a number of options to further progress this program. A grant was awarded by the EU to different EU partners (
The Group has also been awarded grants to investigate its use in age-related macular degeneration, diabetic retinopathy and other ophthalmological indications.
In
The key findings of the study for this compound (referred to in the paper as N6L) were:
· Nucleolin inhibition is a new anti-cancer therapeutic strategy that has been shown to normalise tumour vasculature, have a cytotoxic effect on its own, and to allow a selective targeting of tumour cells.
· As a result, it has the potential to improve dramatically the delivery and efficacy of existing chemotherapeutic drugs such as gemcitabine, and in particular, for difficult-to-treat tumours such as pancreatic cancer and glioblastoma.
Peptide Platform
ImmuPharma's subsidiary 'Ureka' has also initiated the development of a novel and innovative peptide technology platform through the collaboration with CNRS, thereby gaining access to pioneering research centred on novel peptide drugs at the
In February/
As part of the fundraising exercise, ImmuPharma also received confirmation of advance assurance from HM Revenue and Customs that it is a qualifying holding for the purposes of the
Current Activities and Outlook
As a Board, we are excited by ImmuPharma's future potential. ImmuPharma is focused on ensuring the successful development of the late stage clinical development of Lupuzor™ through its pivotal Phase III trial, and I look forward to providing shareholders with further updates as the trial progresses. We are now also beginning to have dialogue with a number of Lupus Patient Groups, both in the UK and the USA, and we will increase our efforts within this important and powerful community throughout this year and beyond.
The key objective for the Group is the completion of the treatment of the 200 lupus patients with top line results on track to be announced during Q1 2018.
ImmuPharma will also progress its other earlier stage pipeline candidates whilst exploring other opportunities around Lupuzor™'s mechanism of action and its applicability through its P140 platform to expand into other autoimmune conditions.
The Board would like to thank its shareholders, both long standing and new for their support as well as its staff, corporate and scientific advisors including Simbec-Orion and the CNRS for their ongoing collaboration.
Tim McCarthy
Non-Executive Chairman
Financial Review
2016 was a year focused on strengthening ImmuPharma's financial position and progressing our lead programme, Lupuzor™, and its pivotal Phase III trial. Two successful placings were completed in 2016; the first, completed in February/
Income Statement
The overall loss for the year ended
Statement of Financial Position
Cash and cash equivalents at
Results
The Group recorded a loss for the year of
Between February and March of 2016 ImmuPharma successfully secured
VCT & EIS Assurance
As part of the fundraising exercise, ImmuPharma also received confirmation of advance assurance from HM Revenue and Customs that it is a qualifying holding for the purposes of the
Lanstead Subscription and Sharing Agreements
As part of the placement completed in
ImmuPharma received seven monthly settlements during 2016. As part of a separate agreement between the Company and Lanstead concluded at the time of the Vendor Placing (see description below), the settlement received in
At the end of the accounting period, the amount receivable is restated to fair value based upon a discounted cash flow calculation using a 10% cost of capital.
On
On
Total Voting Rights
Following the admission of the shares placed in the above 2016 placings to trading on AIM, the Company has a total of 124,638,362 ordinary shares in issue at
Directors' Dealings
All the Directors of the Company participated in the February/
Director |
Number of Ordinary Shares held post subscription at
|
% of |
Robert Zimmer |
25,344,514 |
19.12% |
Tim McCarthy |
38,462 |
0.03% |
Dimitri Dimitriou |
3,567,430 |
2.69% |
Franco Di Muzio |
99,412 |
0.08% |
Stephane Mery |
21,490 |
0.02% |
The Directors together hold 29,071,308 Ordinary Shares, representing 21.94 per cent of the
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 first quarter of 2018 and the progression of its other earlier stage pipeline candidates where cash reserves permit.
Tracy Weimar
Vice President, Operations and Finance
CONSOLIDATED INCOME STATEMENT
FOR THE YEAR ENDED 31 DECEMBER 2016
|
Notes |
Year ended |
|
Year ended |
|
|
|
£ |
|
£ |
|
Continuing operations |
|
|
|
|
|
Revenue |
|
164,784 |
|
76,407 |
|
Research and development expenses |
|
(5,267,087) |
|
(2,993,717) |
|
Administrative expenses |
|
(1,486,858) |
|
(1,645,799) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(6,589,161) |
|
(4,563,109) |
|
|
|
|
|
|
|
Finance costs |
|
(23,085) |
|
(1,208) |
|
Finance income |
|
297,809 |
|
15,843 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before taxation |
|
(6,314,437) |
|
(4,548,474) |
|
|
|
|
|
|
|
Tax |
|
990,421 |
|
650,977 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the year |
|
(5,324,016) |
|
(3,897,497) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Attributable to: |
|
|
|
|
|
Equity holders of the parent company |
|
(5,324,016) |
|
(3,897,497) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per ordinary share |
|
|
|
|
|
|
|
|
|
|
|
Basic |
2 |
(4.54p) |
|
(4.40p) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
2 |
(4.54p) |
|
(4.40p) |
|
|
|
|
|
|
|
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE YEAR ENDED 31 DECEMBER 2016
|
Year ended |
|
Year ended |
|
|
£ |
|
£ |
|
|
|
|
|
|
Loss for the financial year |
(5,324,016) |
|
(3,897,497) |
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income |
|
|
|
|
Items that may be reclassified subsequently to profit or loss: |
|
|
|
|
|
|
|
|
|
Exchange differences on translation of foreign operations |
317,177 |
|
(117,478) |
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income/(loss) for the year, net of tax |
317,177 |
|
(117,478) |
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the year |
(5,006,839) |
|
(4,014,975) |
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 31 DECEMBER 2016
|
|
|
|
|
|
|
Notes |
£ |
|
£ |
|
|
|
|
|
|
|
Non-current assets |
|
|
|
|
|
Intangible assets |
|
511,088 |
|
522,462 |
|
Property, plant and equipment |
|
231,901 |
|
280,127 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total non-current assets |
|
742,989 |
|
802,589 |
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
Trade and other receivables |
|
2,535,265 |
|
1,577,091 |
|
Derivative financial asset |
|
1,554,866 |
|
- |
|
Cash and cash equivalents |
|
1,876,718 |
|
833,388 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
5,966,849 |
|
2,410,479 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Financial liabilities - borrowings |
|
143,109 |
|
163,070 |
|
Trade and other payables |
|
786,191 |
|
1,078,640 |
|
Provisions |
|
15,050 |
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
944,350 |
|
1,241,710 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net current assets |
|
5,022,499 |
|
1,168,769 |
|
|
|
|
|
|
|
Non-current liabilities |
|
|
|
|
|
Financial liabilities - borrowings |
|
219,445 |
|
280,951 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net assets |
|
5,546,043 |
|
1,690,407 |
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY |
|
|
|
|
|
Ordinary shares |
|
12,463,836 |
|
8,862,246 |
|
Share premium |
|
15,678,054 |
|
10,490,920 |
|
Merger reserve |
|
106,148 |
|
106,148 |
|
Other reserves |
|
(3,373,745) |
|
(3,764,673) |
|
Retained earnings |
|
(19,328,250) |
|
(14,004,234) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total equity |
|
5,546,043 |
|
1,690,407 |
|
|
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE YEAR ENDED 31 DECEMBER 2016
|
|
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) |
|
(1,809,372) |
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the financial year
|
- |
|
- |
|
- |
|
- |
|
- |
|
- |
|
(5,324,016) |
|
(5,324,016) |
|
Exchange differences on translation of foreign operations
|
- |
|
- |
|
- |
|
- |
|
317,177 |
|
- |
|
- |
|
317,177 |
|
Share based payments
|
- |
|
- |
|
- |
|
- |
|
- |
|
73,751 |
|
- |
|
73,751 |
|
New issue of equity capital |
3,601,590 |
|
5,798,410 |
|
- |
|
- |
|
- |
|
- |
|
- |
|
9,400,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs of new issue of equity capital |
- |
|
(611,276) |
|
- |
|
- |
|
- |
|
- |
|
- |
|
(611,276) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At |
12,463,836 |
|
15,678,054 |
|
106,148 |
|
(3,541,203) |
|
(1,609,673) |
|
1,777,131 |
|
(19,328,250) |
|
5,546,043 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Attributable to:- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity holders of the parent company |
12,463,836 |
|
15,678,054 |
|
106,148 |
|
(3,541,203) |
|
(1,609,673) |
|
1,777,131 |
|
(19,328,250) |
|
5,546,043 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE YEAR ENDED 31 DECEMBER 2016
|
Notes |
|
Year ended |
|
Year ended |
|
|
|
|
£ |
|
£ |
|
|
|
|
|
|
|
|
Cash flows from operating activities |
|
|
|
|
|
|
Cash used in operations |
3 |
|
(7,191,318) |
|
(4,582,411) |
|
Tax received |
|
|
707,135 |
|
435,261 |
|
Interest paid |
|
|
(1,917) |
|
(1,208) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(6,486,100) |
|
(4,148,358) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
|
Purchase of property, plant and equipment |
|
|
(4,731) |
|
(20,761) |
|
Interest received |
|
|
1,722 |
|
11,541 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(3,009) |
|
(9,220) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
(Decrease)/increase in bank overdraft |
|
|
(1,091) |
|
879 |
|
Loan repayments |
|
|
(143,482) |
|
(333,135) |
|
Loan received |
|
|
- |
|
22,130 |
|
Settlements from Sharing Agreement |
|
|
2,690,451 |
|
- |
|
Gross proceeds from issue of new share capital |
|
|
9,400,000 |
|
- |
|
Share capital issue costs |
|
|
(611,276) |
|
- |
|
Funds deferred per Sharing Agreement |
|
|
(3,949,230) |
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash generated from/(used in) financing activities |
|
|
7,385,372 |
|
(310,126) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase/(decrease) in cash and cash equivalents |
|
|
896,263 |
|
(4,467,704) |
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of year |
|
|
833,388 |
|
5,424,033 |
|
|
|
|
|
|
|
|
Effects of exchange rates on cash and cash equivalents |
|
|
147,067 |
|
(122,941) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of year |
|
|
1,876,718 |
|
833,388 |
|
|
|
|
|
|
|
|
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
|
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 |
(5,324,016) |
|
(3,897,497) |
|
|
|
|
|
|
|
|
|
|
|
Number of shares |
|
|
|
|
Weighted average number of ordinary shares for the purposes of basic earnings per share |
117,340,467 |
|
88,622,463 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic loss per share |
(4.54)p |
|
(4.40)p |
|
|
|
|
|
|
|
|
|
|
|
Diluted loss per share |
(4.54)p |
|
(4.40)p |
|
|
|
|
|
|
|
|
|
|
|
The Group has granted share options in respect of equity shares to be issued, the details of which are disclosed in note 20 of the full set of accounts.
There is no difference between basic loss per share and diluted loss per share as the share options are anti-dilutive. |
3 |
CASH USED IN OPERATIONS |
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|
|
|
|
|
|
Group |
|
Group |
|||||
|
|
|
|
|
|
£ |
|
£ |
|||||
|
Operating loss |
|
|
|
|
(6,589,161) |
|
(4,563,109) |
|||||
|
Depreciation and amortisation |
|
|
|
|
121,337 |
|
121,748 |
|||||
|
Share-based payments |
|
|
|
|
73,751 |
|
- |
|||||
|
(Increase)/decrease in trade and other receivables |
|
|
|
|
(387,713) |
|
(674,440) |
|||||
|
(Decrease)/increase in trade and other payables |
|
|
|
|
(403,414) |
|
552,556 |
|||||
|
Increase/(decrease) in provisions |
|
|
|
|
15,050 |
|
(23,468) |
|||||
|
Gain/(loss) on foreign exchange |
|
|
|
|
(21,168) |
|
4,302 |
|||||
|
|
|
|
|
|
|
|
|
|||||
|
|
|
|
|
|
|
|
|
|||||
|
Cash used in operations |
|
|
|
|
(7,191,318) |
|
(4,582,411) |
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4 |
SUBSEQUENT EVENTS
On
In
|
This information is provided by RNS