Stephen Franklin, Chief Executive Officer of Evgen Pharma, said:
“We were delighted with the positive breast cancer interim data showing good tolerability and efficacy in this very difficult to treat patient population and are hopeful that these trends will be maintained in the final analysis. With final read-outs of the STEM and SAS clinical trials due in Q1 and Q2 2019 respectively we are excited about the near-term prospects of the Company.
“We have also been encouraged by our discussions with leading academics and clinicians who have access to grant funding, and who wish to use SFX-01 for new investigator-initiated trials in non-core indications such as NASH (non-alcoholic steatohepatitis), a subset of non-alcoholic fatty liver disease. These new clinical opportunities have the potential to broaden the use of SFX-01 and thereby build shareholder value.”
Evgen Pharma plc (LON: EVG), the clinical stage drug development company focused on cancer and neurological conditions, announces its unaudited interim results for the six months ended 30 September 2018.
Highlights in the year to date:
· Positive interim data released from ongoing STEM (SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer) Phase IIa clinical study
· Recruitment in STEM study concluded early as the main aims of the trial, being a favourable safety and tolerability profile and evidence of clinical benefit, had been met
· Poster presentation of STEM programme given at 2018 San Antonio Breast Cancer Symposium
· Financial performance in line with expectations:
o Total comprehensive loss of £1.8m (2017: loss of £1.7m)
o Net cash outflow of £1.5m (2017: outflow of £1.7m)
o Cash and short-term investments at 30 September 2018 of £2.2m (30 September 2017: £2.2m)
· Ongoing SAS (SFX-01 after subarachnoid haemorrhage) Phase IIb clinical study is proceeding well with patient recruitment almost complete; but below trend recruitment rate through October and November means the primary endpoint readout is now expected in Q2 calendar year 2019
· Encouraging data in recent preliminary reports from preclinical programmes in triple negative breast cancer, glioblastoma and ischaemic stroke
· Co-authorship of a major review on the therapeutic targeting of the Nrf2 pathway by sulforaphane and other molecules to be published in Nature Reviews Drug Discovery (in press)
· Key process patent grant in Europe concerning the manufacture of lead compound, SFX-01
· Fundraising in October 2018 raised £0.75m before expenses