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Futura Medical looking ahead to completion of key phase III ED trial

Headline results from the trial of MED2005 are due before the end of 2019, while Futura is also confident of hearing back from UK regulators about its pain relief gel later in the year
man with erectile dysfunction
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Futura’s ED gel looks to bring spontaneity back to the bedroom
  • Focused on MED2005 ED gel and TPR100 pain relief gel

  • Products based on its DermaSys skin-based drug delivery system

  • MED2005 phase III trial results due by end of year

  • Seeking UK approval for TPR100

 

What it does

Futura Medical PLC (LON:FUM) is developing a portfolio of products for two large markets: sexual health and pain.

All of its products are based around its DermaSys skin-based drug delivery system.

Perhaps the most exciting product is MED2002, Futura’s erectile dysfunction gel which is designed for those men where the current pill-based treatments aren’t appropriate or carry significant side-effects.

It is currently undergoing a Phase III study in Europe, headline data from which is expected by the end of this year.

The company is also working on three pain relief gels: TPR100, TIB200 and SPR300. Each contains a different painkiller or anti-inflammatory.

TPR100, the most advanced gel, contains diclofenac, TIB200 contains ibuprofen and SPR300, which is a potential follow to those two, contains methyl salicylate.

Futura’s most developed product is CSD500, a condom that is coated in an erectogenic gel which helps men maintain firmer erection for longer.

The condoms were launched in Saudi Arabia last year and more than a million have been sold, but without a major commercial partner, Futura is not putting any more money into this.

 

How it’s doing

With the condom very much on the backburner, Futura is focusing on two things at the minute: its ED gel pain relief gels.

A phase III study of MED2005 kicked off last October and more than 450 patients have been enrolled. Top-line data is expected before the year end.

“The study is going well and we’re looking forward to getting the results at the end of this year,” said chief executive James Barder.

As for TPR100, Futura’s partner Thornton & Ross applied for approval from UK regulators last summer. Discussions with officials are ongoing, but the company is hopeful of reaching a conclusion later this year.

Turning to the financials, the business posted a £5.89mln loss for the year ended December 31.

More importantly, having raised £5.85mln last November (and with cash resources of £9.16mln at the year-end), it has the financial runway to see it through to the data readout for its ED breakthrough. 

 

What the boss says

 

What the broker says

In an initiation note on 17 June, analysts at Liberum said data from Futura’s Phase 3 trial of its MED2005 treatment could drive the share price up over 500%.

The firm’s ‘house’ broker said they expected positive data from the Phase 3 trial for MED2002, which is expected to be delivered by December this year.

Liberum’s analysts believe there is a 70% chance that the Phase 3 study will yield a positive result, while they also forecast peak sales potential for MED2002 at £500mln, ten times the company’s current market cap of £50mln.

The broker added that the Phase 3 trial for MED2002 was “low-risk” as the study currently had 20 realistic outcomes, only one of which would mean the treatment could not be launched commercially.

As a result, Liberum said Futura’s current share price was a “very attractive entry-point” with even its risk-adjusted valuation pointing to upside in the shares of over 100%.

Liberum currently has Futura pegged with a ‘buy’ rating and a target price of 60p, a 144% premium on its current share price.

 

Blue sky

Looking ahead, there are a couple of key inflection points:

Headline results from the phase III trial of MED2005 which are due before the end of the year

A decision from UK regulators on TPR100,which Futura is hearing about later in 2019.

 

With the shares trading around 24.6p as of 17 June 2019, Futura carries a market cap of £50.4mln.



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