‘Transformative’ is the word Huw Jones uses to describe the recent £11million fundraising by Evgen Pharma.
‘It allows us to accelerate some substantial work now,’ the company’s CEO says.
So, what was it the new investors liked about Evgen; what did they see that the wider market didn’t? Well, it’s the same thing that persuaded Jones to join the company last October: SFX-01.
Evgen makes SFX-01 – a compound that has potential applications in cancers, inflammation and acute respiratory distress syndrome (ARDS), including Covid
For those unfamiliar with the Evgen story, SFX-01 is the company’s lead compound that has potential applications in cancers, inflammation and acute respiratory distress syndrome (ARDS), including Covid ARDS.
It is derived from sulforaphane, a compound from nature that Evgen has converted into a fully synthetic, patented drug.
In Sulforadex, the company’s core technology, Evgen has found a method for synthesising and stabilising the naturally occurring compound to a pharmaceutical standard.
And the group’s lead product, SFX-01, is a patented composition of synthetic sulforaphane and alpha-cyclodextrin. ‘In our hands, it’s a drug that is massively biologically active,’ says Jones.
The injection of funds will allow Evgen to improve the manufacturing process around SFX-01 to refine and rescale output.
‘This allows us now to really take it to the pharmaceutical level rather than the prototype formulation, which everybody starts with,’ says Jones.
With a financial runway out to mid-2023, there will be enough in the coffers to fund an ambitious programme, including further work on SFX-01’s potential use in treating metastatic breast cancer and glioma (brain cancer).
On the latter, pre-clinical work will continue before a possible move onto human trials, depending on the data.
An ambition (and a potential significant landmark/catalyst for the business) will be the filing of an investigational new drug application (IND) in the US for SFX-01, though medical indication for the drug hasn’t been decided.
Evgen is also planning to make two key senior hires to support these ambitious plans – a chief business officer and chief scientific and medical officer.
Their job will be to build on the significant progress already made to date in cancers, Covid and acute respiratory distress syndrome.
The company has successfully completed a phase IIa trial of SFX-01 in women with oestrogen-positive (ER+) metastatic breast cancer.
Evgen has successfully completed a phase IIa trial of SFX-01 in women with oestrogen-positive (ER+) metastatic breast cancer.
Data from this trial provided strong early signs of efficacy in this hard-to-treat patient group with the compound either halting the tumour growth or, in some cases, significantly reducing it.
Preclinical work is now being carried out with Manchester University to assess the possible impact of its discovery in patients that have become resistant to CDK4/6 inhibitor drugs such as the blockbuster Ibrance.
If successful, this evaluation would pave the way for a second phase II trial.
In cancer, SFX-01 has been shown to halt or even shrink tumours. The drug candidate also stimulates, or ‘upregulates’, the Nrf2 pathway, which is part of the natural human defence against inflammatory and oxidative stress that occurs during severe viral infection.
With this in mind, Evgen has embarked on a phase II/III clinical trial to assess the potential efficacy of SFX-01 in patients with acute respiratory problems, the majority of whom are likely to have been infected by coronavirus.
Specifically, researchers will investigate whether SFX-01 can reduce the severity or prevent the onset of acute respiratory distress syndrome (ARDS) in pneumonia patients.
Even before the pandemic, there were 190,000 ARDS cases a year in the US. It has a very poor prognosis and few effective treatment options.
Analysts expect top-line results from the research, which is being carried out by scientists from Dundee University and funded by the medical charity Life Arc, towards the end of the year.
A total of 109 people have been recruited to the ‘randomised’ STAR trial. ‘In collaboration with Dundee we also want to take [an early] peek at the efficacy data,’ says Jones.
SFX-01 appears to be the gift that keeps on giving if the results from pre-clinical models of glioma and glioblastoma are anything to go by. Jones called the results ‘compelling’ and it is easy to see why.
Lab work carried out in collaboration with the University of L’Aquila in Abruzzo, Italy, showed tumour shrinkage and significantly extended survival times.
SFX-01 was also found to substantially increase the therapeutic effect of radiotherapy in these models.
While research is currently at the very preliminary stage, it does at least point to a future method of combatting this form of brain cancer, which has a poor prognosis.
Jones says Evgen is likely to follow the initial research being carried out by the collaboration partner with a phase II clinical trial.
‘It’s not a very crowded space either in terms of the pipeline or products in the market, which consists of radiotherapy and one chemotherapy drug,’ he explains.
‘So, in terms of indication selection, we couldn’t be in a better place particularly given the power of the data we’ve got, and the unmet clinical need.’
What comes through clearly from the foregoing – and a point spotted by the new investors joining the Evgen register – is the company is not some binary life-sciences one-trick pony.
Each area or drug indication for SFX-01 represents a value inflexion point that could deliver significant upfront and milestone payments as well as royalties on sales of a commercial product.
Analysts and investors refer to a company in this position as having multiple shots on goal – the idea being the more shots a life sciences business has the more likely it is to score a drug success.
A sleeper in the Evgen portfolio is its deal with entrepreneur Jim Mellon’s Juvenescence, which has licensed the non-pharmaceutical/nutraceutical rights to the Sulforadex platform.
The tie-up is worth around $10.5million in milestone payments and future royalties to Evgen.
FinnCap, the company’s broker, has assessed the nascent potential of Evgen and come up with a 29p a share valuation (using a risk-adjusted discounted cash flow calculation) – some 20p more than the current share price.
Analyst Mark Brewer describes Evgen as ‘not without risk’ but adds that ‘multiple shots on goal provide investors substantial upside potential, given the number of opportunities that exist for monetising SFX-01 and Sulforadex’.
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