Interim results for the six months ended 30 June 2020
Leeds, UK, 30 September, 2020 – 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutics, is pleased to announce the interim results for the Company and its subsidiaries (together “the Group”) for the six months ended 30 June 2020.
• Net assets at 30 June 2020 of £31.5 million (30 June 2019: £35.0 million and 31 December 2019: £22.3 million).
• Cash and cash equivalents and short-term deposits at 30 June 2020 of £10.0 million (30 June 2019: £12.9 million and 31 December 2019: £3.8 million).
• Loss and total comprehensive income for the six months ended 30 June 2020 of £13.6 million (30 June 2019: £11.3 million and 31 December 2019: £23.7 million).
• Research and development expenditure for the six months ended 30 June 2020 of £12.4 million (30 June 2019: £10.8 million and 31 December 2019: £26.5 million).
• Delivered the first global clinical evidence of the safety and therapeutic potential of oral Live Biotherapeutics in cancer, in an interim analysis of 4D’s clinical trial of MRx0518 in combination with Keytruda®. The Part A safety phase of the ongoing trial was successfully completed in May, and the Part B cohort expansion phase commenced in June.
• Completed an interim analysis of a Phase II trial of irritable bowel syndrome (IBS) candidate Blautix® which demonstrated non-futility in the primary endpoint and a safety profile comparable to placebo.
• Commenced a clinical trial of immunomodulatory candidate MRx-4DP0004 in hospitalised COVID-19 patients. The Company’s rapid response was enabled by a detailed understanding of its drug candidates driven by the MicroRx® platform, and the safety profile of Live Biotherapeutics.
• Appointed Prof. Dr. Axel Glasmacher as Non-Executive Chairperson. Prof. Glasmacher joined 4D pharma as a Non-Executive Director in 2019. His vast experience in the successful development of novel cancer therapies at Celgene will be critical in guiding the clinical development of 4D pharma’s pipeline of Live Biotherapeutics.
Since the period end
• In July 2020 4D pharma undertook a fundraise through the issue of new Ordinary Shares to raise approximately £7.7 million in gross proceeds (£7.3 million net). The additional funding provides working capital into Q1 2021 and allows sufficient cash runway to achieve a number of major clinical readouts across multiple programmes including oncology, respiratory and gastrointestinal diseases.
• In August 4D pharma announced comprehensive clinical benefit data from Part A of the trial. The 42% disease control rate observed in Part A of our ongoing trial far exceeded the predefined 10% threshold for expansion in Part B.
• 4D pharma CSO Dr. Alex Stevenson and Research Director Dr. Imke Mulder hosted an R&D webinar in which Dr. Mulder and senior members of her team discussed the Company’s MicroRx® platform and development pipeline, as well as successes of 4D pharma’s functional approach to the discovery and development of Live Biotherapeutics, followed by a Q&A session with eight participating analysts.
• Appointment of Dr. Katrin Rupalla as a Non-Executive Director. Dr. Rupalla brings vast experience to 4D pharma with over 20 years of experience in the pharmaceutical industry, and extensive regulatory and development expertise in the fields of oncology and neuroscience.
Axel Glasmacher, Non-Executive Chairperson of 4D pharma, commented: “2020 has undeniably been a defining period for the Live Biotherapeutics field, and 4D pharma has continued building its leading position. We announced proof-of-concept efficacy data in oncology for lead candidate MRx0518, and have made meaningful progress in other important therapeutic areas. In concert with this growth, 4D has further expanded both its leadership expertise and its international shareholder base. 4D pharma now looks ahead to the remainder of 2020 and beyond, as we continue to deliver clinical data and pioneer this rapidly developing new area of medicine.”
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