Evgen Pharma plc (AIM: EVG), the clinical stage drug development company developing sulforaphane based medicines for the treatment of multiple diseases, announces its audited results for the year ended 31 March 2021.
Research and Development
· Phase IIb/III trial using SFX-01 for acute respiratory distress syndrome ("ARDS"), including COVID-19 patients, sponsored by the University of Dundee and NHS Tayside, with grant funding from LifeArc; the "STAR" trial (SFX-01 treatment for acute respiratory infections). 133 patients recruited to date
· Safety data review by independent Data Monitoring Committee ("DMC") of 60 randomised patients concluded there were no concerns regarding patient safety. Further assessment by the DMC of unblinded data from 100 randomised patients for safety and futility will be performed imminently
· Exciting pre-clinical data generated in glioma/glioblastoma - preparations under way for randomised, blinded Phase I/II clinical trial to start in H1/2022
· In vitro data suggests that SFX-01 may suppress tumour growth in patients with oestrogen receptor positive breast cancer who have become resistant to CDK4/6 inhibitors such as palbociclib (sold as Ibrance by Pfizer)
· Encouraging in vitro data that SFX-01 may also be effective in treating blood cancers such as the severe form of childhood leukaemia, juvenile myelomonocytic leukaemia (JMML), linked to new evidence that SFX-01 inhibits a further pathway of relevance in many cancers
· Completion of first out-licensing deal with Juvenescence for use of Sulforadex® technology in non-pharmaceutical markets. Up to $10.5m receivable in milestones with royalties on sales, expected from mid-2023
· Funding round of £11m (before costs) will accelerate Evgen's development programmes
Strengthened Management Team
· Senior management team strengthened and expanded with appointments of Dr Huw Jones (CEO) and, post year end, Dr Glen Clack as Chief Medical Officer and Dr Helen Kuhlman as Chief Business Officer
· Financial performance in-line with expectations:
o Post tax loss of £2.7m (2020: loss of £2.7m)
o Cash outflow from operations of £2.9m (2020: outflow of £2.6m)
o Cash and short-term deposits at 31 March 2021 of £11.6m (31 March 2020: £4.1m)
Barry Clare, Chairman of Evgen Pharma, said: "Over the last 12 months Evgen has substantially strengthened its senior team, made considerable progress across all areas of its business, raised significant funding to accelerate the development of its therapeutic programmes and concluded its first commercial partnership. I look forward to continuing our success in the current year and would like to thank our shareholders for their continued support."