ImmuPharma PLC (LON:IMM), the specialist drug discovery and development company, has today announced its interim results for the six months ended 30 June 2018.
Key Highlights
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. However, due to the high response rate in the placebo group, this superior response did not allow statistical significance to be reached (p = 0.2631) and the trial’s primary end point was not met.
· Across the whole study population, in those patients who had anti-dsDNA autoantibodies, LupuzorTM demonstrated a superior response rate over placebo (61.5% vs 47.3%, p = 0.0967). Although these results were not statistically significant, further data analysis demonstrated that in the Europe cohort (130 patients) LupuzorTM plus standard of care showed statistically significant reductions in disease activity compared to placebo plus standard of care in 79 patients who were anti-dsDNA autoantibody positive (71.1% vs 48.8%, p = 0.0218).
· The study confirmed the outstanding safety profile of LupuzorTM, with no serious adverse events reported.
· As announced on 7 September 2018, agreement signed with a specialist provider to enter LupuzorTM into a ‘Managed Access Programme’.
· Open label extension study completes recruitment.
Other programs
· Nucant (cancer) program – Clinical Development Collaboration with Incanthera Limited.
· Peptide platform program / Ureka subsidiary – ImmuPharma to begin divestment process.
Financial Position
· £10 million fundraising (before expenses) successfully completed in January 2018.
· Stable financial performance over the Period, in line with market expectations
o Net assets of £9.9 million (31 December 2017: £3.6 million)
o Loss for the period of £4.1 million (H1 2017: £3.0 million)
§ Research and Development expenses of £2.5 million (H1 2017: £2.3 million)
o Basic and diluted loss per share of 2.94p (H1 2017: 2.34p)
Appointment of new joint brokers
· Stanford Capital Partners and SI Capital appointed as joint brokers, working in conjunction with current NOMAD and broker, Northland Capital Partners.
Commenting on the Interims and outlook Tim McCarthy, ImmuPharma PLC Chairman, said:
“The Board is pleased to announce the interim results for the six months ended 30 June 2018. It has been a busy period for the Board following the announcement of the Phase III trial results for Lupuzor in April 2018. We remain focused on delivering a business strategy which provides the optimum route forward for ImmuPharma and its shareholders, based on its current assets, resources and knowhow. We were obviously disappointed with the outcome of the Phase III trial results but are excited to be progressing the Managed Access Programme with a new strategic partner, which allows lupus patients early access to LupuzorTM. In the medium term, we remain focussed on achieving the full regulatory approval of LupuzorTM which we believe has the potential to be a ground breaking drug for lupus patients with blockbuster potential in commercial terms.
Our Nucant programme and Ureka subsidiary have been part of our portfolio for a number of years. We are equally excited by the potential of both. We believe the strategy we announced earlier this month, together with a robust financial position, will create enhanced value for shareholders going forward.”
CHAIRMAN’S STATEMENT
INTERIM HIGHLIGHTS
The first half of 2018 saw the completion of our pivotal Phase III trial for LupuzorTM, our candidate for the treatment of lupus. Top-line results were announced on 17 April 2018 with further analysis provided on 29 May 2018. Following these results, ImmuPharma has recently signed an agreement with a specialist provider to distribute LupuzorTM via a Managed Access Programme. This will allow lupus patients early access to LupuzorTM prior to any regulatory filing.
ImmuPharma has, on 6 September 2018, signed a Heads of Terms on a clinical development collaboration for the Nucant cancer programme with Incanthera Limited, a specialist oncology development company. Further, following an extensive review, it has been decided that the Company’s Ureka subsidiary which focuses on peptide treatments for metabolic disorders is not part of the ongoing strategy of ImmuPharma which is now fully focused on utilising its resources to develop late stage assets. Consequently, we are beginning the process of divesting Ureka.
In other developments, we were pleased to have completed a successful fund raising of £10 million (before expenses) in January 2018. The fund raising was supported by long term shareholders and the addition of new institutional and private investors.
LupuzorTM Phase III results and next steps
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™ 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. However, due to the high response rate in the placebo group, this superior response did not allow statistical significance to be reached (p = 0.2631) and the trial’s primary end point was not met.
Across the whole study population, in those patients who had anti-dsDNA autoantibodies, LupuzorTM demonstrated a superior response rate over placebo (61.5% vs 47.3%, p = 0.0967). Although these results were not statistically significant, further data analysis demonstrated that in the Europe cohort (130 patients) LupuzorTM plus standard of care showed statistically significant reductions in disease activity compared to placebo plus standard of care in 79 patients who were anti-dsDNA autoantibody positive (71.1% vs 48.8%, p = 0.0218).
The study confirmed the outstanding safety profile of LupuzorTM, with no serious adverse events reported.
Scientific literature indicates that approximately 60% – 70% of patients diagnosed for lupus are anti-dsDNA autoantibody positive. These proportions were seen in the Europe cohort (60.8% of patients) and could therefore be considered as representative of the overall lupus population.
In those patients who were anti-dsDNA autoantibody negative, there was almost no difference in disease activity reduction between the active group and the comparator group. Anti-dsDNA autoantibodies are a recognised biomarker for Systemic Lupus Erythematosus.
This finding indicates that the activity of LupuzorTM could be correlated with the presence of anti-dsDNA autoantibodies in lupus patients. ImmuPharma believes that predictive biomarkers, such as anti-dsDNA autoantibodies, could allow identification of patients that are more likely to respond positively to treatment with LupuzorTM.
LupuzorTM next steps – Managed Access Program
ImmuPharma is planning to move forward with a Managed Access Program for LupuzorTM. Recognising that lupus is a disease with significant unmet medical need and given the advanced level of clinical trial investigation completed, ImmuPharma would like to meet demand for access to LupuzorTM by lupus patients who, together with their physicians, request it.
Extension study
The LupuzorTM extension study, which was announced on 18 January 2018, is continuing and recruitment is now complete with a total of 62 patients eligible from the original Phase III trial. We believe that this will provide more valuable information on the potential efficacy and safety of LupuzorTM. The study is anticipated to report results in Q2 2019.
Nucant Platform
A number of options have been under review to develop the Company’s Nucant cancer programme, which has demonstrated promising results in two Phase I trials (safety and dose-finding studies).
In order to progress the programme, on 6 September 2018 ImmuPharma signed Heads of Terms on a clinical development collaboration for the Nucant cancer programme, with Incanthera Limited (“Incanthera”), a specialist oncology development company.
Key highlights of the Heads of Terms are summarised below:
· Incanthera, based on its positive due-diligence on the Company’s Nucant technology, will license in and take up the continued clinical development of the Nucant cancer programme as an integral part of its own cancer development portfolio.
· As an integral part of the collaboration, upon signing the Heads of Terms, ImmuPharma has invested £2m into Incanthera by subscribing for 363,637 new ordinary Incanthera shares at a price of £5.50 per share. This investment values Incanthera at a pre-money valuation of approximately £10m and is consistent with the most recent funding round that Incanthera completed in March 2018. Following this investment, ImmuPharma will have a circa 16% shareholding in Incanthera.
· ImmuPharma has granted Incanthera a period of exclusivity until 31 December 2018, during which the Company and Incanthera will finalise the terms of a Definitive Licence Agreement for the Nucant technology. These terms are expected to include, but will not be limited to the following:
o Incanthera will pay a licence payment to ImmuPharma of £1 million, with this payment to be made via the issuance of new ordinary shares in Incanthera. This payment in shares is separate and will be in addition to the shareholding which Immupharma currently holds as described above;
o Incanthera will be responsible for all of the development costs for the Nucant programme; and,
o All future commercialisation revenues will be shared equally between the two companies.
Ureka – Divestment process
Ureka, ImmuPharma’s wholly owned subsidiary, based in Bordeaux, which is carrying out research into treatments for Type II diabetes and NASH (Non-Alcoholic-Steato-Hepatitis) has recently demonstrated success in recognised preclinical studies.
Following an extensive review by ImmuPharma’s Board of directors, it has been decided that Ureka, whilst having exciting and innovative technologies, is not part of the ongoing strategy of ImmuPharma, which is now fully focused on utilising its resources to develop late stage assets.
As such, ImmuPharma, with its advisors, will now commence a process of considering all opportunities to divest Ureka. The intention is to allow ImmuPharma to divest Ureka, whilst still retaining an interest in any future commercial success.
Financial Review
ImmuPharma’s cash balance at 30 June 2018 was £9.02 million (£2.73 million at 31 December 2017, £3.13 million at 30 June 2017). Basic and diluted loss per share were 2.94p and 2.94p respectively (30 June 2017: 2.34p and 2.34p). In line with the Company’s current policy, no interim dividend is proposed.
Operating loss for the Period was £4.1 million (£3.2 million for the six months ended 30 June 2017). Research and development expenditure in the Period was £2.5 million (£2.3 million for the six months ended 30 June 2017) reflecting primarily the expenditure related to the LupuzorTM Phase III clinical trial. Administrative expenses were £1.0 million during the Period (£0.8 million for the six months ended 30 June 2017). The share based expense was £775k (£131k for the period ended 30 June 2017) which includes a reduction for the National Insurance provision which was nil due to the decrease in share price from 31 December 2017 to 30 June 2018.
Given the stage of ImmuPharma’s development, the fact that losses have continued to be made is to be expected since there is minimal revenue and business activity is concerned with significant investment in the form of clinical development expenditure, in addition to maintaining the infrastructure of the Company.
Current Activities and Outlook
The Board has been focused on delivering a business strategy which provides the optimum route forward for ImmuPharma and its shareholders, based on its current assets, resources and knowhow. We are excited to be progressing the Managed Access Programme which allows lupus patients early access to LupuzorTM. In the medium term, we remain focussed on achieving the full regulatory approval of LupuzorTM which we believe has the potential to be a ground breaking drug for lupus patients with blockbuster potential in commercial terms.
Our Nucant programme and Ureka subsidiary have been part of our portfolio for a number of years. We are equally excited by the potential of both. We believe the strategy we are pursuing with the collaboration with Incanthera Limited for the Nucant and for divestment of Ureka will create enhance value for shareholders going forward.
The Board would like to thank its shareholders, both longstanding and those who participated in the January 2018 fundraising, for their support as well as its staff, corporate and scientific advisers including Simbec-Orion and the CNRS (Centre Nationale de la Recherche Scientifique) for their continued collaboration.
Tim McCarthy
Chairman
