David Norwood, Chairman of 4D pharma, commented: “Through the successful development of its clinical programmes in the first half of 2018, the Company continues to lead the development of Live Biotherapeutics, as we seek to secure robust clinical data to support the use of this new class of drugs across multiple indications, and from there to progress towards our goal of producing Live Biotherapeutics as safe and effective therapies. I would once again like to thank the Board, our employees and our shareholders for their continued support.”
4D pharma plc (LON: DDDD), a pharmaceutical company leading the development of Live Biotherapeutics, today announced the interim results for the Company and its subsidiaries for the six months ended 30 June 2018.
Financial highlights
· Net assets as at 30 June 2018 of £58.7 million (30 June 2017: £75.3 million and 31 December 2017: £69.8 million)
· Cash and cash equivalents and short-term deposits at 30 June 2018 of £36.6 million (30 June 2017: £59.8 million and 31 December 2017: £50.0 million)
· Loss attributable to the owners of the parent undertaking for the six months ended 30 June 2018 of £11.3 million (30 June 2017: £11.3 million* and 31 December 2017: £19.4 million*)
· Research and development expenditure for the six months ended 30 June 2018 of £11.8 million (30 June 2017: £8.3 million and 31 December 2017: £16.9 million)
Operational and clinical highlights
· Entering into clinical collaboration agreement with subsidiary of MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA) to conduct a clinical trial evaluating the combination of KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy marketed by MSD, and 4D’s Live Biotherapeutic candidate MRx0518 in patients with solid tumours; the phase I study will evaluate safety, tolerability and preliminary clinical benefit of the combination of KEYTRUDA® with MRx0518 in patients who progressed on prior PD-1 inhibitor therapy with renal, bladder, melanoma and non-small cell lung cancer
· Clearance by the Medicines and Healthcare Products Regulatory Agency (“MHRA”) of the Clinical Trial Application for MRx0518, the first Live Biotherapeutic trial in cancer; the first-in-human, two-part phase Ib study will evaluate the safety, tolerability and anti-tumour immuno-modulatory effects of MRx0518 in patients with multiple solid tumour types
· Clearance by the US Food and Drug Administration (“FDA”) of an Investigational New Drug Application for Blautix, the Group’s Live Biotherapeutic for the treatment of Irritable Bowel Syndrome (“IBS”); the double-blind, placebo-controlled multicentre phase II study will evaluate the efficacy and safety of Blautix in patients with IBS with constipation (“IBS-C”) and IBS with diarrhoea (“IBS-D”)
· Clearance by the MHRA and the Health Products Regulatory Authority (“HPRA”) to commence the phase II study of Blautix at sites in the UK and Ireland
Since the period end
· Positive top-line results for the Phase Ib study of the Company’s Live Biotherapeutic Thetanix in paediatric patients with Crohn’s disease; achieving the primary objective of demonstrating that Thetanix was well tolerated with a good safety profile
