Futura Medical PLC (AIM:FUM, OTC:FAMDF) looks financially well set for the commercial phase of the journey of its lead product, MED3000 for erectile dysfunction.
Interim results for the group showed it had £6.68mln in the bank as of June 30, 2022, the period's end, with a further £910,000 in research and development tax credits set for payment in the second half.
This, it said, provided it with resources beyond the initial product launches of MED3000 and its expected US regulatory approval.
Branded Eroxon, the fast-acting gel has European regulatory clearance and, in August, received ‘highly positive results’ from its US phase III trial.
The company will file the data packages required by the US Food & Drug Administration later this month with the aim of approval in the first quarter of next year as the only ED treatment available over the counter in the States.
Eroxon will compete with existing blue pills on the speed of onset and will be targeted at men who have suffered side effects from using products such as Viagra and Cialis.
Plans are advanced for its launch in the first half of next year. Futura has a licensing agreement with Cooper Consumer Health for the rights to commercialise the gel throughout the European Economic Area, the United Kingdom and Switzerland.
“The whole team at Futura looks forward with growing excitement to the launch of Eroxon in the coming months as we, in close alignment with our commercial partners, work hard to build Eroxon into a long-term, profitable and trusted brand,” said the company's chief executive James Barder in a statement.
The results revealed the company posted a £2.5mln loss for the six months ended June 30, 2022.