Encouraging interim data from the STEM trial

Evgen (EVG) is a virtual pharmaceutical company focused on the development of a synthetic version of a natural product, sulforaphane, which is known to modulate key signalling pathways involved in cellular protection and inflammation. EVG has created new and stable variants of sulforaphane using its proprietary technology, Sulforadex, enabling it to be used as a therapeutic for the first time. SFX-01 is currently in Phase II trials for both subarachnoid haemorrhage (SAH) and ER+ breast cancer, with read-outs expected around the end of 2018. Meanwhile, EVG has disclosed positive interim data from its STEM trial in metastatic breast cancer.

• Strategy: Evgen is focused on the clinical development of synthetic and stable variants derived from sulforaphane using its proprietary technology, Sulforadex. Lead candidate SFX-01 is being assessed in Phase II trials for SAH and breast cancer, both strategic entry portals for other uses in neurology and oncology.
• Interim data: Of the 44 patients recruited to date, interim analysis has been performed on 20 patients, who had disease progression prior to starting the trial. Six have seen a beneficial effect of SFX-01 on their tumours, with, four having their disease halted to at least 24 weeks and two to 18 weeks. Furthermore, among them, two show partial response i.e. tumour shrinkage.
• Positive results: It is probably too early to draw any firm conclusions, but these initial data provide reassurance that the trial may hit its primary end-point of safety, tolerability and signs of efficacy in this hard-to-treat population. Despite these encouraging data, the share price did not respond as expected.
• Risks: As with all drug development companies, there is a risk that products will fail in clinical trials. However, sulforaphane has been through a number of encouraging clinical trials despite its stability and dosing limitations. Therefore, coupled with two potential targets, Evgen’s risk profile is arguably reduced.
• Investment summary: SFX-01 would be entering multi-billion-dollar global markets that are currently unsatisfied. There is also potential to use sulforaphane in other indications. Evgen intends to out-license its drugs to the pharma majors for commercialisation. Despite some share price appreciation recently, the enterprise value afforded to Evgen by the market does not reflect properly the development stage of SFX-01, and lower than usual risk profile.