On June 8, 2022 Evgen Pharma plc (AIM: EVG), the clinical stage drug development company developing sulforaphane-based medicines for the treatment of multiple diseases, reported its audited results for the year ended 31 March 2022 (Press release, Evgen, JUN 8, 2022, View Source;newsid=1592002 [SID1234616036]).
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Operational highlights
· In vitro pre-clinical work supports SFX-01 use in metastatic breast cancer patients who have become resistant to the widely used class of CDK4/6 inhibitor drugs
· Malignant glioma Orphan Drug Designation for SFX-01 granted by FDA
· Publication of positive preclinical in vitro and in vivo data in glioblastoma from two independent groups of collaborators, in Italy and New Zealand
· Encouraging early in vitro data for SFX-01 in Juvenile Myelomonocytic Leukaemia ("JMML") at the MRC Weatherall Institute, University of Oxford
· Scale-up of the active ingredient in SFX-01 to commercial scale achieved with a number of process improvements
· JuvLife partnership around the application of the Sulforadex technology continues to progress well; US market launch of a JuvLife nutritional health product is anticipated around end- 2023
· New formulation of SFX-01 generated in tablet form enabling scale-up to supply late-stage clinical trials and commercial use
· r Helen Kuhlman and Dr Glen Clack appointed as Chief Business Officer and Chief Medical Officer respectively, completing the senior management team
· utlook:
o Intention to start healthy volunteer trial in Q4 2022 with new SFX-01 formulation
o Final preclinical work in GBM completed and now in late-stage preparation for a Phase Ib/IIa trial due to start in Q4 2022
o New academic collaborations with La Sapienza University, Rome in SFX-01 radiosensitisation and Michigan University in colon cancer
Financial highlights
· Financial performance in-line with expectations:
o Cash and short-term deposits at 31 March 2022 of £9.0m (31 March 2021: £11.6m); Group funded to Q4/2023
o Post-tax loss of £2.7m (2021: loss of £2.7m)
o Cash outflow from operations of £2.6m (2021 outflow of £2.9m)
Dr Huw Jones, CEO of Evgen Pharma, said:
"Our focus during the year has been on achieving the objectives set at our 2021 fundraise, particularly around manufacturing, formulation and clinical trials preparation. With this groundwork now complete, we are pleased to have achieved very visible progress in each of our development programmes and we are anticipating another busy year which will include clinical data from both the Phase I/Ib volunteer and Phase Ib/IIa glioblastoma trials."