Evgen Pharma PLC – Half-year Report

Evgen Pharma plc (AIM: EVG), the clinical stage drug development company developing sulforaphane based medicines for the treatment of multiple diseases, announces its unaudited interim results for the six months ended 30 September 2019.

 

Operational highlights

·    Positive results from the STEM trial of SFX-01 in metastatic breast cancer presented at European Society of Medical Oncology Congress in Barcelona, demonstrating the stabilisation of previously progressive disease and objective responses in some patients

·    Five patients who participated in the STEM trial received SFX-01 treatment for over one year with no tumour progression

·    Results from the SFX-01 After Subarachnoid Haemorrhage (“SAS”) trial did not meet primary or secondary efficacy endpoints, however the treatment was well tolerated with no safety concerns

·    Agreements in principle reached with Guy’s and St Thomas’ NHS Foundation Trust and University of Dundee to support clinical trials of SFX-01 in autism and non-alcoholic steatohepatitis (“NASH”) respectively

·    Research collaboration with King’s College London and the British Heart Foundation to investigate how SFX-01 mediates upregulation of Nrf2 in the blood-brain barrier endothelium in-vivo

 

Financial highlights

·    Financial performance in-line with expectations:

o  Total comprehensive loss of £1.6m (2018: loss of £1.8m)

o  Cash outflow from operations of £1.7m (2018: outflow of £1.5m)

o  Cash balance at 30 September 2019 of £5.1m (30 September 2018: £2.2m)

·    Oversubscribed fundraising in April 2019 raised £5.0m before expenses

 

Stephen Franklin, Chief Executive Officer of Evgen Pharma, said: “We have now completed two Phase II trials on SFX-01, in different conditions and with quite separate mechanistic hypotheses. Our selections of metastatic breast cancer (“mBC”) and Subarachnoid Haemorrhage (“SAH”) were based on strong preclinical data sets. The mBC clinical result was positive, demonstrating the stabilisation of previously progressive disease in 24% of patients and objective responses in some others. We were surprised that the SAH trial did not similarly follow the preclinical data, albeit this is a particularly challenging indication. However, the scientific evidence for sulforaphane and SFX-01 as a potent Nrf2 activator is compelling, and the clinical belief in Nrf2 activation as a therapeutic strategy is affirmed by the endorsement of our clinical investigator partners, who wish to test SFX-01 in various diseases where Nrf2 activation is important. We therefore remain committed to the on-going clinical development of SFX-01 both in breast cancer, and in supporting trials in a range of other diseases which may benefit from Nrf2 up-regulation”.

 

“We therefore move forward with the confidence that clinical success will ultimately prevail and we will, at that point, see a major ground shift in the Company’s valuation. Between now and that point we will focus on delivering our development plan; the fundamentals that are needed to underpin sustainable share price growth and ultimately deliver the undoubted potential of SFX-01”.

 

“We will be arranging to meet institutional and retail investors in early 2020 and look forward to this opportunity to discuss our strategy for the next stage in our development.”