Northland Capital partners view on Evgen Pharma PLC: The commencement of Evgen’s first Phase II clinical trial is a major milestone for the company. There have been no significant clinical advances for more than 20 years in SAH. We estimate that SFX-01 could qualify for orphan drug status in this indication, potentially giving it extended market exclusivity and making it easier and faster for the treatment to gain marketing approval. Evgen is on target for the trial to read out in Q2-2018.
| First Patient Dosed in Phase II Clinical Trial in SAH |
| n Evgen announced that the first patient has been dosed in the Company’s Phase II clinical trial of SFX-01 in aneurysmal subarachnoid haemorrhage (SAH), a form of stroke.
n The market potential for SAH, with its high unmet clinical need, is significant. n SFX-01 is a synthetic version of sulforaphane, a known neuroprotective and anti-cancer agent, which is stabilised in a novel patented complex using a proprietary manufacturing process. n The Phase II trial is a randomised, double blind, placebo controlled study comparing oral SFX-01 with placebo. n The trial will recruit 90 patients, 45 in each treatment arm with all patients receiving nimodipine, the current standard of care. Nimodipine has been generic for more than 20 years, during which time there have been no significant clinical advances in the treatment of SAH. n SFX-01 targets the principal drivers of delayed vasospasm characteristic of SAH strokes. However, unlike nimodipine, it is not trying to treat just the vasospasm per se, and as such it may represent the first step-change improvement in therapy in over 20 years. n Patients will be dosed within 48 hours of experiencing SAH and approval has also been obtained in this study to provide for emergency dosing prior to consent. n The primary endpoints include safety, pharmacokinetics and efficacy. It is expected that the SAS trial will read out in Q2 2018. |
| Year end Mar | Revs (£m) | Adj. EBITDA (£m) | Adj. PBT (£m) | Tax (%) | Adj. EPS (p) | PER (x) | Div (p) | Net cash (£m) | Yield (%) | |||||||||
| 2015A | – | -1,168,000 | -2,233,000 | – | – | – | – | -900,000 | – | |||||||||
| 2016E | – | -4,092,800 | -3,500,000 | – | -4.8 | – | – | 5,370,200 | – | |||||||||
| 2017E | – | -2,993,520 | -3,000,000 | – | -4.12 | – | – | 2,476,680 | – | |||||||||
| 2018E | 5,000,000 | 1,405,832 | 1,400,000 | – | 1.69 | 16.3 | – | 3,992,512 | – | |||||||||
| Source: Northland Capital Partners Limited. |
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Northland Capital partners view: The commencement of Evgen’s first Phase II clinical trial is a major milestone for the company. There have been no significant clinical advances for more than 20 years in SAH. We estimate that SFX-01 could qualify for orphan drug status in this indication, potentially giving it extended market exclusivity and making it easier and faster for the treatment to gain marketing approval. Evgen is on target for the trial to read out in Q2-2018. |
