Final Results Announcement for the twelve months ended 31 December 201729th May 2018 - 9:25 am
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 expectationso 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 2018o 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”)