Futura Medical PLC (AIM:FUM, OTC:FAMDF) appears financially well prepared for the commercial phase of the journey of its flagship product, MED3000 for erectile dysfunction.
The group’s interim results showed it had £6.68m in the bank at 30 June 2022, the end of the period, with a further £910,000 in research and development tax credits to be paid in the second semester.
This, he said, provided him with resources beyond the initial launches of the MED3000 product and its expected U.S. regulatory approval.
Branded Eroxon, the fast-acting gel gained European regulatory clearance and in August received “very positive results” from its Phase III trial in the United States.
The company will file data sets required by the U.S. Food & Drug Administration later this month with the goal of seeking approval in the first quarter of next year as the only treatment for erectile dysfunction available over-the-counter in the United States.
Eroxon will compete with existing blue pills on speed of onset and will target men who have experienced side effects using products such as Viagra and Cialis.
Plans are being made for it to launch in the first half of next year. Futura has a license agreement with Cooper Consumer Health for the rights to market the gel throughout the European Economic Area, the United Kingdom and Switzerland.
“The entire Futura team looks forward to the launch of Eroxon in the months ahead as we, working closely with our business partners, work hard to build Eroxon into a long-term, profitable and trusted brand.” , the company’s chief executive, James Barder, said in a statement.
The results revealed that the company recorded a loss of £2.5 million for the six months to June 30, 2022.