Last checked at 29 May 2018 07:00
29 MAY 2018
ImmuPharma PLC
("ImmuPharma" or the "Company")
FINAL RESULTS ANNOUNCEMENTfor the twelve months ended 31 December 2017
ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, is pleased to announce its final results for the twelve months ended 31 December 2017 (the "Period").
Key Highlights (including post Period review)
· Stable financial performance over the Period, in line with market expectations
o Cash balance of £2.7 million (31 December 2016: £1.9 million) which has since been augmented by the £10 million (before expenses) placing in January 2018.
o Loss for the period of £6.2 million (31 December 2016: £5.3 million)
§ Research and development expenses of £5.1 million (31 December 2016: £5.3 million)
o Basic and diluted loss per share of 4.75p (31 December 2016: 4.54p)
· The Company's pivotal Phase III trial of Lupuzor™, the Company's potential breakthrough compound for lupus, a potential life threatening auto-immune disease, completed in January 2018
o Pivotal Phase III trial with 202 lupus patients
§ 11 sites in the US with 72 patients
§ 81 patients took part in the trial across 5 European countries: France, Germany, Hungary, Czech Republic and Poland
§ 49 patients in Mauritius included in trial
· Top line results of the Company's pivotal Phase III trial of LupuzorTM were announced on 17 April 2018- key highlights include:
o Lupuzor™ plus Standard of Care ("SOC")* demonstrated a superior response rate over placebo plus SOC (52.5% vs 44.6% "responders"**) in the primary analysis on the Full Analysis Set of all 202 patients (including withdrawals who are considered non-responders). However, due to a high response rate in the placebo plus SOC group, this superior response did not allow statistical significance to be reached (p = 0.2631) and the primary end point was not met.
o Lupuzor™ plus SOC also demonstrated a superior response rate over placebo plus SOC (68.8% vs 59.2%) in the 153 patients who completed the study.
o Importantly, in patients who were anti-dsDNA autoantibody positive (a recognised biomarker for Systemic Lupus Erythematosus ('SLE'), LupuzorTM plus SOC demonstrated a superior response rate over placebo plus SOC (61.5% vs 47.3%). In addition, 7.6% of the patients in the LupuzorTM plus SOC group went into full remission versus none in the placebo plus SOC group.
o The study confirmed the outstanding safety profile of Lupuzor™, with zero drug-related serious adverse events reported in the LupuzorTM plus SOC group.
* "Standard of Care" includes treatment with other drugs such as steroids, anti-malarials, methotrexate etc. It is important to note that when reference is made to placebo, there are no patients who were treated with just placebo as all were receiving other drug treatments at the same time, in addition to LupuzorTM.
** The definition of a "responder' is based on the SLE Responder Index (SRI-4) score, which requires a reduction of at least four points in this score. Therefore, patients who improve by less than four points are not counted, but also no distinction is made between patients who improve by more than 4 points, all being equal "responders".
· Follow-on 'extension' open label study
o As announced on 18 January 2018, following requests from both investigators and patients involved in the Phase III trial, ImmuPharma has initiated an additional clinical trial permitting patients who participated in the Phase III study, to receive Lupuzor™ plus SOC for six months in an open-label scheme. Patient recruitment began in late 2017.
o 44 patients have already been recruited with recruitment being closed by the end of June 2018.
o Results are anticipated in 2019.
· Two successful, value accretive fundraisings to strengthen the Company's financial position as negotiations continue with potential partners for Lupuzor™ and to support further investment in ImmuPharma's product pipeline
o £4.1 million (gross) fundraising completed in March 2017, including EIS qualifying shares
o £10 million (gross) fundraising in January 2018
o Both fundraisings were supported by existing long term shareholders together with the addition of new institutional investors and private investors
· Other program developments
o ImmuPharma's subsidiary, Ureka, whose labs are based in Bordeaux at the facilities of the CNRS has discovered inter alia a new drug for the treatment of NASH (Non-Alcoholic-Steato-Hepatitis) and Type II diabetes which has demonstrated significant efficacy in recognised preclinical studies. ImmuPharma's new lead candidate in this therapeutic area is code-named URK-614 and is a very long-acting GLP-1 analogue with potential for once a month administration. This promising novel molecule is protected by a series of patents co-owned by Ureka and CNRS under the umbrella of Ureka's URELIXTM technologies which facilitates the fabrication of new drug compounds on the basis of physiologically active peptides.
o A number of options are under review to further progress ImmuPharma's Nucant program, IPP-204106 which showed promising results in cancer and age-related macular degeneration (AMD) models. Two Phase I trials have been completed (safety and dose-finding studies).
· Bryan Garnier & Co. appointed as Joint Broker on 28 March 2018
Commenting on the statement and outlook Tim McCarthy, Chairman, said:
"As a Board, we continue to be excited by ImmuPharma's future potential. Looking at the Lupuzor™ top line data announced in April, the drug demonstrated a superior response rate over placebo with an exceptional safety profile, giving it, we believe, a compelling product profile. We believe Lupuzor™ has the potential to bring a much needed safe treatment to the millions of lupus sufferers around the world. The Company's remaining product pipeline is also promising with notable developments in NASH and Type II diabetes in particular. We continue to engage with potential partners and are focused on moving forward with the development and commercialisation of Lupuzor™ for lupus. Although no guarantees of a successful outcome can be given at this stage, we look forward to providing our shareholders with further updates in due course.
"With a strong balance sheet following the £10 million fund raising in January, ImmuPharma will look to progress its other earlier stage pipeline candidates whilst also exploring other opportunities based on Lupuzor™'s mechanism of action and its potential 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, scientific and corporate collaborators including the CNRS, Simbec-Orion and CAP Research."
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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ImmuPharma plc
Chairman's Report
2017 and the beginning of 2018 marked an important milestone event for ImmuPharma. The phase III clinical trial for our lead program, LupuzorTM was completed, and top line results for the trial were announced post year-end. ImmuPharma completed two successful fundraising rounds raising a total of £14.1 million before expenses. In March 2017, the Company raised £4.1 million before expenses. In addition, a further £10 million fundraising round before expenses was completed in January 2018. These fundraisings were supported by existing long term shareholders together with the addition of new institutions and private investors onto our share register.
Lupuzor™: progress through 2017
LupuzorTM, ImmuPharma's lead program for the treatment of lupus completed its Phase III clinical trial in January 2018 which involved patients in the US, Europe and Mauritius. Initial top line results were announced on 17 April 2018, see details below.
The Phase III trial was a double-blind, randomised, placebo-controlled trial. The study involved patients being dosed for one year, receiving 0.2mg once per month subcutaneously. 293 patients were screened illustrating the demand from physicians for a new, safe and effective treatment for lupus. Of these, the required 202 patients were successfully recruited and randomised (dosed). Patients participated in the trial in 7 countries across 28 sites.
The clinical trial was undertaken primarily by Simbec-Orion, an international clinical research organisation, who specialises in rare and orphan conditions and has previous direct experience in lupus trials. This was a pivotal study designed to demonstrate the safety and efficacy of Lupuzor™.
Lupuzor™ received approval from the US Food and Drug Administration (FDA) to start Phase III with a Special Protocol Assessment (SPA) and Fast Track designation.
Lupuzor™ Phase III Top Line Results
On 17 April 2018 ImmuPharma announced top line results of its pivotal Phase III trial of Lupuzor
Key highlights:
· Lupuzor™ plus Standard of Care ("SOC")* demonstrated a superior response rate over placebo plus SOC (52.5% vs 44.6% "responders")** in the primary analysis on the Full Analysis Set of all 202 patients (including withdrawals who are considered non-responders). However, due to a high response rate in the placebo plus SOC group, this superior response did not allow statistical significance to be reached (p = 0.2631), and the primary end-point was not met.
· Lupuzor™ plus SOC also demonstrated a superior response rate over placebo plus SOC (68.8% vs 59.2%) in the 153 patients who completed the study.
· Importantly, in patients who had anti-dsDNA autoantibodies (a recognised biomarker for Systemic Lupus Erythematosus ('SLE')), LupuzorTM demonstrated a superior response rate over placebo (61.5% vs 47.3%). In addition, 7.6% of these patients in the LupuzorTM group went into full remission versus none in the placebo group.
· The study confirmed the outstanding safety profile of Lupuzor™, with zero drug-related serious adverse events reported in the LupuzorTM plus SOC group.
* "Standard of Care" includes treatment with other drugs such as steroids, anti-malarials, methotrexate etc. It is important to note that when reference is made to placebo, there are no patients who were treated with just placebo as all were receiving other drug treatments at the same time, in addition to LupuzorTM.
** The definition of a "responder' is based on the SLE Responder Index (SRI-4) score, which requires a reduction of at least four points in this score. Therefore, patients who improve by less than four points are not counted, but also no distinction is made between patients who improve by more than 4 points, all being equal "responders".
Extension Open Label Study
Following requests from both investigators and patients involved in the Phase III trial, ImmuPharma has initiated an additional clinical trial permitting patients who participated in the Phase III study, to receive Lupuzor™ plus SOC for six months in an open-label scheme. The results will be gathered as an "extension" open label study, independent of the pivotal Phase III trial and will provide additional data on the safety and efficacy of LupuzorTM. Patient recruitment began in late 2017 and 44 patients have already been recruited. Patient recruitment will be closed by the end of June 2018, and it is anticipated that results will be available in 2019.
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: Lupus Foundation of America). Current 'standard of care' treatments, including steroids and immunosuppressants, can potentially have either serious side effects for patients or limited effectiveness, with over 60 per cent of patients not adequately treated.
The Company beieves 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.
Despite the top line results for the Phase III trial, the Board believes there are still a number of routes to market for Lupuzor™ which could include: a global licensing deal; ImmuPharma partnering with regional distributors, globally or an outright acquisition 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 French National Council for Scientific Research and the largest basic research organisation in Europe, relating to the therapeutic use of peptides and peptide derivatives. This is where Lupuzor™ was invented by Prof. Sylviane Muller, Research Director at CNRS. This successful and longstanding relationship plays an important role in the progress of ImmuPharma's development pipeline.
Pipeline Overview
LupuzorTM / Forigerimod / P140 in Autoimmune Indicaitons
Lupuzor™, is also known by its chemical name 'Forigerimod' or P140. ImmuPharma in conjunction with the CNRS are exploring opportunities on expanding into other auto immune indications, as demonstrated by Lupuzor™'s profile and by its mechanism of action.
Certain auto immune indications, outside of lupus, have the potential for Orphan Drug designation. Further assessment continues with the objective of further indications moving into the clinic in due course.
Nucant Program
Our cancer Nucant program, IPP-204106, is focused on combination therapy approaches. Two Phase I/IIa trials were performed (focused on safety and dose-range finding). ImmuPharma is now reviewing a number of options to further progress this program. A grant was awarded by the EU to different EU partners (€7 million total with €430k awarded to ImmuPharma) to develop the Nucants in combination with cytotoxic drugs linked to a solid support. The molecule has also shown promising results in age-related macular degeneration models.
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 University of Bordeaux and the Institut Européen de Chimie et Biologie (IECB). Jointly, ImmuPharma and CNRS have filed a series of new co-owned patents controlling this breakthrough peptide technology. The first therapeutic area being targeted is diabetes with glucagon-like peptide -1 agonists, a class of drugs for the treatment of diabetes, as well as initiating the development of novel peptides as glucagon agonists - one of the novel approaches to treat Type I and Type II diabetes. These peptides could also have a beneficial effect in the treatment of NASH for which very few treatment options exist.
£14.1 million Fund Raising (£4.1 million in March 2017 and £10 million post period end)
ImmuPharma strengthened its financial position through two fundraisings. In March 2017, the Company announced the completion of a placing of 7,884,623 new ordinary shares of 10p each at a placing price of 52p raising a total of £4.1 million before expenses. The shares are EIS and VCT qualifying. Major existing and new institutional investors participated in the New Share Placing.
In January 2018, the Company announced the completion of a placing of 6,944,445 new ordinary shares of 10p each at a placing price of 144p raising a total of £10 million before expenses. The Company raised the funds in order to further strengthen the Company's financial position as negotiations continue with potential partners for Lupuzor™ and to support further investment in ImmuPharma's earlier stage portfolio. The Company continues to be a qualifying company for purposes of the Enterprise Investment Scheme and the Venture Capital Trust rules.
The January 2018 placing gross proceeds of £10 million added to the Group's cash and cash equivalent position of £2.7 million (2016: £1.9 million) at 31 December 2017.
Completion of Lanstead Sharing Agreement
In September 2017, ImmuPharma announced the completion of the Sharing Agreement entered into in February 2016. As announced on 5 February 2016, Lanstead subscribed for £4.4 million of new ordinary shares in ImmuPharma, with both parties also entering into the Sharing Agreement. All 18 settlements of the Sharing Agreement have been completed. Through both the subscription and the Sharing Agreement, ImmuPharma has received a total of just over £5 million from Lanstead since February 2016, with a net gain of £0.6 million more than originally subscribed.
New Share Option Plan
Following the closing of the Company's previous share option plan to new grants, ImmuPharma adopted a new 10 year employee share option plan. The implementation of this share option plan is intended to align the interests of the Company's executive directors and eligible employees with shareholders, and to attract talent in the future. Further details of the new share option plan can be found in the Financial Review.
Current Activities and Outlook
As a Board, we continue to be excited by ImmuPharma's future potential. Looking at the Lupuzor™ top line data announced in April, the drug demonstrated a superior response rate over placebo with an exceptional safety profile, giving it, we believe, a compelling product profile. We believe Lupuzor™ has the potential to bring a much needed safe treatment to the millions of lupus sufferers around the world. We continue to engage with potential partners and, although no guarantees of a successful outcome can be given at present, we are focused on moving forward with the development and commercialisation of Lupuzor™. The remaining pipeline is also very promising with notable developments in NASH and Type II diabetes. We look forward to providing our shareholders with further updates in due course.
With a strong financial position following the recent £10 million fund raising, ImmuPharma will look to progress its other pipeline candidates whilst continuing the development of Lupuzor™, in lupus as well as other autoimmune conditions based on its mechanism of action.
The Board would like to thank its shareholders, both long standing and new for their support as well as its staff, scientific and corporate collaborators including the CNRS, Simbec-Orion and CAP Research.
Tim McCarthy
Non-Executive Chairman
ImmuPharma plc
Financial Review
2017 was a year focused on strengthening ImmuPharma's financial position and progressing our lead programme, Lupuzor™ and its pivotal Phase III trial. A successful share placing was completed in March 2017, raising £4.1 million (before expenses).
Income Statement:
The operating loss for the year ended 31 December 2017 was £7.2 million up from £6.6 million for the year ended 31 December 2016. The increase in overall loss was mainly attributable to share-based expense of £743k (2016: £89k) which was attributable to the number of share options granted in 2017. Research and development expenditure was £5.1 million down slightly from £5.3 million in 2016. This reflects the front-loading of a portion of the Lupuzor clinical trial expenses. Administrative expenses were £1.5 million up from £1.4 million in the year ended 31 December 2016. Finance income was £240k for 2017 which was down slightly from £298k for 2016. Finance income is mainly attributable to a gain in fair value on the derivative financial asset. Total comprehensive loss for the year was £6.3 million, which was up from £5 million in 2016.
Statement of Financial Position:
Cash and cash equivalents at 31 December 2017 amounted to £2.7 million (2016: £1.9 million). Financial borrowings were £260k (2016: £360k). This balance is primarily the conditional advance from the French Government for use in the development of our cancer program. No interest is payable. In March 2017, ImmuPharma successfully completed a share placing and subscription, raising £4.1 million before expenses. In addition, a further share placing, raising £10 million before expenses was completed in January 2018. Further details can be found below.
Results:
The Group recorded a loss for the year of £6.2 million (2016: £5.3 million). Basic and diluted loss per share was 4.75p (2016: 4.54p). In accordance with the Group's loss making position no dividend is proposed.
March 2017 and January 2018 (post period) Placings - £14.1 million before expenses raised
ImmuPharma strengthened its financial position through two fundraisings. In March 2017, the Company announced the completion of a placing of 7,884,623 new ordinary shares of 10p each at a placing price of 52p raising a total of £4.1 million before expenses. The shares are EIS and VCT qualifying. Major existing and new institutional investors participated in the New Share Placing.
In January 2018, the Company announced the completion of a placing of 6,944,445 new ordinary shares of 10p each at a placing price of 144p raising a total of £10 million before expenses. The Company raised the funds in order to further strengthen the Company's Statement of Financial Position as negotiations continue with potential partners for Lupuzor™ and to support further investment in ImmuPharma's earlier stage portfolio. The Company continues to be a qualifying company for purposes of the Enterprise Investment Scheme and the Venture Capital Trust rules.
Completion of Lanstead Sharing Agreement
In September 2017, ImmuPharma announced the completion of the Sharing Agreement entered into in February 2016. As announced on 5 February 2016, Lanstead subscribed for £4.4 million of new ordinary shares in ImmuPharma, with both parties also entering into the Sharing Agreement. All 18 settlements of the Sharing Agreement have been completed. Through both the subscription and the Sharing Agreement, ImmuPharma has received a total of just over £5 million from Lanstead since February 2016, with a net gain of £0.6 million more than originally subscribed.
New Share Option Plan
Following the closing of the Company's previous share option plan to new grants, ImmuPharma adopted a new 10 year employee share option plan. The implementation of this share option plan is intended to align the interests of the Company's executive directors and eligible employees with shareholders, and to attract talent in the future.
The key terms of the Share Option Plan are summarised below:
· The Share Option Plan is used to grant options over the Company's ordinary shares of 10p each ("Ordinary Shares") to ImmuPharma's employees and executive directors;
· The Company's non-executive directors or any self-employed individuals who provide consultancy services to the Company will not be granted options pursuant to the Share Option Plan;
· Under the Share Option Plan, up to 10% of the Company's issued share capital at any time is reserved for issuance, measured over a rolling ten year period. This limit takes into account Ordinary Shares or treasury shares that could be issued or used to satisfy existing options;
· The Company's Remuneration Committee may impose performance conditions over the grant of options and these conditions may be varied, substituted or waived as deemed appropriate by the Remuneration Committee; and
· Options will be granted with an exercise price equal to the market value of the Company's shares at the date of grant, i.e. the closing mid-market price from the preceding business day.
A number of options were granted during 2017. The total options outstanding under both the 2017 Share Option Plan and the Company's previous share option plan is 10,130,000, representing 7.64% (7.26% post January 2018 placing) of ImmuPharma's Ordinary Shares and total voting rights on a fully diluted basis. The total options outstanding that have been granted to non-employees and consultants is 6,085,000. The total warrants outstanding is 153,850. Taken altogether, there are currently 16,368,850 outstanding options and warrants, representing 12.35% (11.74% post January 2018 placing) of ImmuPharma's Ordinary Shares and total voting rights on a fully diluted basis.
Total Voting Rights
Following the admission of the shares placed in the above 2017 placings to trading on AIM, the Company had a total of 132,522,985 ordinary shares in issue at 31 December 2017 with each share carrying the right of one vote. Following the post period placing completed in January 2018, the Company has 139,467,430 ordinary shares in issue with each share carrying the right of one vote.
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 development assets.
Tracy Weimar
Vice President, Operations and Finance
ImmuPharma plc
CONSOLIDATED INCOME STATEMENT
FOR THE YEAR ENDED 31 DECEMBER 2017
|
Notes | Year ended 31 December 2017 |
| Year ended 31 December 2016 |
|
|
| £ |
| £ |
|
Continuing operations |
|
|
|
|
|
Revenue |
| 150,462 |
| 164,784 |
|
Research and development expenses |
| (5,121,388) |
| (5,267,087) |
|
Administrative expenses |
| (1,520,356) |
| (1,398,057) |
|
Share based payment expense |
| (742,752) |
| (88,801) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
| (7,234,034) |
| (6,589,161) |
|
|
|
|
|
|
|
Finance costs |
| (3,858) |
| (23,085) |
|
Finance income |
| 240,447 |
| 297,809 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before taxation |
| (6,997,445) |
| (6,314,437) |
|
|
|
|
|
|
|
Tax |
| 774,244 |
| 990,421 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the year |
| (6,223,201) |
| (5,324,016) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Attributable to: |
|
|
|
|
|
Equity holders of the parent company |
| (6,223,201) |
| (5,324,016) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per ordinary share |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted | 2 | (4.75p) |
| (4.54p) |
|
|
|
|
|
|
|
|
|
|
|
|
|
ImmuPharma plc
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOMEFOR THE YEAR ENDED 31 DECEMBER 2017
| Year ended 31 December 2017 |
| Year ended 31 December 2016 |
|
| £ |
| £ |
|
|
|
|
|
|
Loss for the financial year | (6,223,201) |
| (5,324,016) |
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income |
|
|
|
|
Items that may be reclassified subsequently to profit or loss: |
|
|
|
|
|
|
|
|
|
Exchange differences on translation of foreign operations | (91,568) |
| 317,177 |
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income/(loss) for the year, net of tax | (91,568) |
| 317,177 |
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the year | (6,314,769) |
| (5,006,839) |
|
|
|
|
|
|
|
|
|
|
|
ImmuPharma plc
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 31 DECEMBER 2017
|
| 31 December 2017 |
| 31 December 2016 |
|
| Notes | £ |
| £ |
|
|
|
|
|
|
|
Non-current assets |
|
|
|
|
|
Intangible assets |
| 482,268 |
| 511,088 |
|
Property, plant and equipment |
| 161,399 |
| 231,901 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total non-current assets |
| 643,667 |
| 742,989 |
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
Trade and other receivables |
| 736,212 |
| 1,379,679 |
|
Derivative financial asset |
| - |
| 1,554,866 |
|
Cash and cash equivalents |
| 2,729,468 |
| 1,876,718 |
|
Current tax asset |
| 907,916 |
| 1,155,586 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
| 4,373,596 |
| 5,966,849 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Financial liabilities - borrowings |
| (142,393) |
| (143,109) |
|
Trade and other payables |
| (929,569) |
| (786,191) |
|
Provisions |
| (57,517) |
| - |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
| (1,129,479) |
| (929,300) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net current assets |
| 3,244,117 |
| 5,037,549 |
|
|
|
|
|
|
|
Non-current liabilities |
|
|
|
|
|
Financial liabilities - borrowings |
| (117,297) |
| (219,445) |
|
Provisions |
| (195,989) |
| (15,050) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net assets |
| 3,574,498 |
| 5,546,043 |
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY |
|
|
|
|
|
Ordinary shares |
| 13,252,299 |
| 12,463,836 |
|
Share premium |
| 18,728,519 |
| 15,678,054 |
|
Merger reserve |
| 106,148 |
| 106,148 |
|
Other reserves |
| (2,961,017) |
| (3,373,745) |
|
Retained earnings |
| (25,551,451) |
| (19,328,250) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total equity |
| 3,574,498 |
| 5,546,043 |
|
|
|
|
|
|
|
|
|
|
|
|
|
ImmuPharma plc
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE YEAR ENDED 31 DECEMBER 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 1 January 2016 | 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 operation |
- |
|
- |
|
- |
|
- |
|
317,177 |
|
- |
|
- |
|
317,177 |
| Transactions with owners: 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 31 December 2016 | 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 year
| - |
| - |
| - |
| - |
| - |
| - |
| (6,223,201) |
| (6,223,201) |
| Exchange differences on translation of foreign operations
|
- |
|
- |
|
- |
|
- |
| (91,568) |
|
- |
|
- |
| (91,568) |
| Transactions with owners: Share based payments
|
- |
|
- |
|
-
|
|
- |
|
- |
|
504,296 |
|
- |
|
504,296 |
| New issue of equity capital | 788,463 |
| 3,311,542 |
| - |
| - |
| - |
| - |
| - |
| 4,100,005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Costs of new issue of equity capital | - |
| (261,077) |
| - |
| - |
| - |
| - |
| - |
| (261,077) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| At 31 December 2017 | 13,252,299 |
| 18,728,519 |
| 106,148 |
| (3,541,203) |
| (1,701,241) |
| 2,281,427 |
| (25,551,451) |
| 3,574,498 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Attributable to:- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Equity holders of the parent company | 13,252,299 |
| 18,728,519 |
| 106,148 |
| (3,541,203) |
| (1,701,241) |
| 2,281,427 |
| (25,551,451) |
| 3,574,498 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ImmuPharma plc
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE YEAR ENDED 31 DECEMBER 2017
| Notes |
| Year ended 31 December 2017 |
| Year ended 31 December 2016 | |
|
|
| £ |
| £ | |
|
|
|
|
|
| |
Cash flows from operating activities |
|
|
|
|
| |
Cash used in operations | 3 |
| (5,439,079) |
| (7,191,318) | |
Tax received |
|
| 1,021,915 |
| 707,135 | |
Interest paid |
|
| (3,858) |
| (1,917) | |
|
|
|
|
|
| |
|
|
|
|
|
| |
Net cash used in operating activities |
|
| (4,421,022) |
| (6,486,100) | |
|
|
|
|
|
| |
|
|
|
|
|
| |
Investing activities |
|
|
|
|
| |
Purchase of property, plant and equipment |
|
| (25,491) |
| (4,731) | |
Interest received |
|
| 772 |
| 1,722 | |
|
|
|
|
|
| |
|
|
|
|
|
| |
Net cash used in investing activities |
|
| (24,719) |
| (3,009) | |
|
|
|
|
|
| |
|
|
|
|
|
| |
Financing activities |
|
|
|
|
| |
(Decrease)/increase in bank overdraft |
|
| (290) |
| (1,091) | |
Loan repayments |
|
| (114,386) |
| (143,482) | |
Settlements from Sharing Agreement |
|
| 1,667,380 |
| 2,690,451 | |
Gross proceeds from issue of new share capital |
|
| 4,100,005 |
| 9,400,000 | |
Share capital issue costs |
|
| (261,077) |
| (611,276) | |
Funds deferred per Sharing Agreement |
|
| - |
| (3,949,230) | |
|
|
|
|
|
| |
Net cash generated from financing activities |
|
| 5,391,632 |
| 7,385,372 | |
|
|
|
|
|
| |
|
|
|
|
|
| |
Net increase in cash and cash equivalents |
|
| 945,891 |
| 896,263 | |
|
|
|
|
|
| |
Cash and cash equivalents at beginning of year |
|
| 1,876,718 |
| 833,388 | |
|
|
|
|
|
| |
Effects of exchange rates on cash and cash equivalents |
|
| (93,141) |
| 147,067 | |
|
|
|
|
|
| |
|
|
|
|
|
| |
|
|
|
|
|
| |
Cash and cash equivalents at end of year |
|
| 2,729,468 |
| 1,876,718 | |
|
|
|
|
|
| |
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 31 December 2017 or 31 December 2016.
The financial information has been extracted from the statutory accounts for the years ended 31 December 2017 and 31 December 2016. The auditors reported on those accounts; their reports were unqualified and did not contain a statement under either Section 498(2) or Section 498(3) of the Companies Act 2006 in respect of the years ended 31 December 2017 and 31 December 2016 and did not include references to any matters to which the auditor drew attention by way of emphasis.
The Group's statutory accounts for the year ended 31 December 2016 have been delivered to the Registrar of Companies, whereas those for the year ended 31 December 2017 will be delivered to the Registrar of Companies following the Company's Annual General Meeting.
The accounting policies are consistent with those applied in the preparation of the interim results for the period ended 30 June 2017 and the statutory accounts for the year ended 31 December 2016, which have been prepared in accordance with International Financial Reporting Standards ("IFRS").
The financial information is for the year ended 31 December 2017 and the comparatives are for the year ended 31 December 2016.
The Group's statutory accounts incorporate the financial statements of ImmuPharma plc and other entities controlled by the company ("the subsidiaries"). Control is achieved where the company has the power to govern the financial and operating policies of an investee entity so as to obtain benefits from its activities.
|
2 | LOSS PER SHARE - Group | Year ended 31 December 2017 |
| Year ended 31 December 2016 |
|
| £ |
| £ |
| Loss |
|
|
|
| Loss for the purposes of basic loss per share being net loss after tax attributable to equity shareholders |
(6,223,201) |
|
(5,324,016) |
|
|
|
|
|
|
|
|
|
|
| Number of shares |
|
|
|
| Weighted average number of ordinary shares for the purposes of basic earnings per share |
130,902,857 |
|
117,340,467 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Basic loss per share | (4.75)p |
| (4.54)p |
|
|
|
|
|
|
|
|
|
|
| Diluted loss per share | (4.75)p |
| (4.54)p |
|
|
|
|
|
|
|
|
|
|
| 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 | ||||||||||||
|
|
|
|
|
| Group 31 December 2017 |
| Group 31 December 2016 | |||||
|
|
|
|
|
| £ |
| £ | |||||
| Operating loss |
|
|
|
| (7,234,034) |
| (6,589,161) | |||||
| Depreciation and amortisation |
|
|
|
| 138,198 |
| 121,337 | |||||
| Share-based payments |
|
|
|
| 504,296 |
| 73,751 | |||||
| Decrease/(increase) in trade and other receivables |
|
|
|
| 643,466 |
| (387,713) | |||||
| Increase/(decrease) in trade and other payables |
|
|
|
| 143,378 |
| (403,414) | |||||
| Increase/(decrease) in provisions |
|
|
|
| 238,456 |
| 15,050 | |||||
| Gain/(loss) on foreign exchange |
|
|
|
| 127,161 |
| (21,168) | |||||
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
| |||||
|
Cash used in operations |
|
|
|
|
(5,439,079) |
|
(7,191,318) | |||||
|
|
|
|
|
|
|
|
| |||||
|
| ||||||||||||
|
|
|
|
| |||||||||
|
|
|
|
| |||||||||
|
|
|
|
| |||||||||
|
| ||||||||||||
|
| ||||||||||||
|
| ||||||||||||
|
| ||||||||||||
|
| ||||||||||||
|
| ||||||||||||
4 | SUBSEQUENT EVENTS
On 24 January 2018, the Company announced the completion of a placing of 6,944,445 new ordinary shares of £0.10 each at a placing price of £1.44 raising a total of £10 million before expenses. Major existing and new institutional investors have participated in the New Share Placing. The Company raised the funds in order to support further investment in the P140 peptide platform and to provide additional working capital to strengthen the Company's Statement of Financial Position as negotiations continue with potential partners for Lupuzor™. Following the Admission of the shares placed, the Company has a total of 139,467,430 ordinary shares in issue with each share carrying the right of one vote.
On 17 April 2018, the Company announced the initial results of the Phase III clinical trial for LupuzorTM. Lupuzor™ demonstrated a superior response rate over placebo (52.5% vs 44.6% "responders") in the primary analysis on the Full Analysis Set of all 202 patients (including withdrawals who are considered non-responders). However, due to a high response rate in the placebo group, this superior response did not allow statistical significance to be reached and the primary end-point was not met. Lupuzor™ also demonstrated a superior response rate over placebo (68.8% vs 59.2%) in the 153 patients who completed the study. Importantly in patients who had anti-dsDNA autoantibodies (a recognised biomarker for Systemic Lupus Erythematosus ('SLE')), Lupuzor™ demonstrated a superior response rate over placebo (61.5% vs 47.3%). In addition, 7.6% of these patients in the Lupuzor™ group went into full remission versus none in the placebo group. Importantly, the study confirmed the outstanding safety profile of Lupuzor™, with zero serious adverse events reported.
|