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
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:
ImmuPharma plc (www.immupharma.org) |
+ 44 (0) 20 7152 4080 |
Tim McCarthy, Chairman |
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Lisa Baderoon, Head of Investor Relations Twitter: @immupharma |
+ 44 (0) 7721 413496 |
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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 |
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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