Final Results

RNS Number : 4390P
Immupharma PLC
29 May 2018
 

                                                                                                                       29 MAY 2018

 

 

ImmuPharma PLC

("ImmuPharma" or the "Company")

 

FINAL RESULTS ANNOUNCEMENT
for 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

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.

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)

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

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:

 

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 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. 

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

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.

44 patients have already been recruited with recruitment being closed by the end of June 2018.

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

£4.1 million (gross) fundraising completed in March 2017, including EIS qualifying shares

£10 million (gross) fundraising in January 2018

Both fundraisings were supported by existing long term shareholders together with the addition of new institutional investors and private investors

 

·      Other program developments

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.

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:

 

ImmuPharma plc (www.immupharma.org)

+ 44 (0) 20 7152 4080

Tim McCarthy, Chairman

 

Lisa Baderoon, Head of Investor Relations

Twitter: @immupharma

 

+ 44 (0) 7721 413496

 

 

 

 

Northland Capital Partners Limited (NOMAD & Joint Broker)

David Hignell, Dugald Carlean, Jamie Spotswood, Corporate Finance

Rob Rees, Corporate Broking

 

 

+44 (0)20 3861 6625

 

 

 

 

Bryan, Garnier & Co. (Joint Broker)             

Phil Walker, Corporate Finance

Dominic Wilson, Sales

 

 +44 (0)20 7332 2500

 

 

 

 

 

 

 

 

     
 

 

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 INCOME
FOR 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.

 

 

 

 

 

 


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END
 
 
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Immupharma (IMM)
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