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 2023.
Operational highlights
Phase 1/1b SFX-01 healthy volunteer study formally completed. Quality assurance work completed on schedule and clinical study report issued. Results consistent with top line data reported in FY 2022/23; no SFX-01 related serious adverse events (SAEs), release of drug from enteric coated tablets confirmed and in the range seen in successful laboratory experiments.
Non-dilutive funding of c.EUR0.6m secured, towards glioblastoma pre-clinical and clinical studies with Erasmus University Medical Center, Rotterdam, NL.
Collaboration with University La Sapienza di Roma, Italy on SFX-01 in rhabdomyosarcoma models showed radio-sensitisation by SFX-01 in vivo, complementing earlier in vitro results. These results support the mechanism of action of SFX-01 in glioblastoma where radiotherapy is also standard of care.
Publication of radiosensitisation data planned by University La Sapienza group.
Retirement of Chair Barry Clare, Dr Susan Foden appointed interim Chair. Appointment of experienced industry executive Toni Hanninen as CFO.
Post period
Discussions continue with partner Stalicla SA on optimal design of the Phase 2 study in autism spectrum disorder.
Further exploratory analysis of gene expression data via RNA sequencing from the Phase 1/1b healthy volunteer study commissioned, mining a vast data set of potential changes in gene expression after exposure to SFX-01.
Non-dilutive grant-funded glioblastoma work led by Dr Marjolein Geurts at the Erasmus University Medical Center, Cancer Institute, Rotterdam commenced on schedule.
Financial highlights
Financial performance in line with expectations: Post-tax loss of GBP1.5m (2022: GBP2.1m)
Cash outflow from operations of GBP1.3m (2022: GBP1.9m)
Cash deposits, cash and cash equivalents balance on 30 September 2023 of GBP3.7m (30 September 2022: GBP7.2m)
Cash runway remains unchanged to end of 2024 excluding further milestones from the Stalicla SA out-license agreement.
Chief Executive Officer of Evgen Pharma, said: 'During the period substantial progress was made in characterizing our commercial grade tablet formulation, further advancing our knowledge of the mechanism of SFX-01 and moving towards clinical studies in glioblastoma through non-dilutive funding. We continue to interrogate the effect of SFX-01 in our Phase 1/1b study on the expression of genes of interest to our oncology studies and relevant in autism spectrum disorder in collaboration with our partner Stalicla SA.
'SFX-01 continues to show promise as a radio-sensitisation agent in serious cancers where radiotherapy is the mainstay of treatment. The recent results from our collaborators at La Sapienza in Rome confirmed the effect in vivo in models of rhabdomyosarcoma. This gives further strength to our hypothesis in glioblastoma where similar results were seen in models of this fatal brain cancer.
'Our Chair Barry Clare retired during the period and the board would like to thank him for his long, dedicated service to the company. I'm grateful to Dr Susan Foden for agreeing to be our interim Chair and also welcome Toni Hanninen as CFO.
'In conclusion, we continue to be well positioned to commercialise the potential of SFX-01 across various indications through our own studies and in many productive collaborations.'
Contact:
Dr Huw Jones
Tel: +44 1625 466591
Melanie Toyne-Sewell
Tel: +44 207 457 2020
About Evgen Pharma plc
Evgen Pharma is a clinical stage drug development company developing sulforaphane based medicines for the treatment of multiple diseases. The Company's core technology is Sulforadex, a method for synthesising and stabilising the highly biologically active compound sulforaphane and novel proprietary analogues based on sulforaphane.
The Company's lead asset, SFX-01, is a patented composition of synthetic sulforaphane and alpha-cyclodextrin and has undergone clinical trials for oestrogen-positive (ER+) metastatic breast cancer and recently a Phase 1b study of the Company's new enteric coated tablet formulation. The FDA has granted Orphan Drug status to SFX-01 in malignant glioma. SFX-01 will be investigated initially in this indication as an investigator sponsored study in the Netherlands.
The Company also has a wide number of collaborations with leading academic centres in the UK, Europe and the US as part of the continuing strategy to build the scientific data for the compound. Recently, Evgen completed an out-licensing transaction with Stalicla SA, a Swiss specialist company in neurodevelopmental disorders, commencing with autism spectrum disorder. The deal, if successful, will generate milestone payments of $160.5m and a double-digit royalty on sales.
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