The pharma developer expects the final certificate of European CE mark approval for the medical device by the end of May, while it is focused on the confirmatory clinical study and non-clinical studies to finalise an OTC label in the US, which it aims to achieve in 2022.
WATCH: Futura Medical confirm US Food & Drug Administration agreement ‘hot on heels’ of EU regulatory steps
The AIM-listed firm said there is potential for quick medical device registrations in most Middle East, Far East, African and Latin American countries based on the CE mark, so it is looking forward to a global rollout.
Futura said the GBP2mln cash investment arising from the MED3000 collaboration agreement for China and South East Asia secured in March and April added to a year-end cash balance of GBP1.02mln. These and a refund of R&D tax credits of GBP500,000 will provide funding until the first quarter of 2022.
It will focus on formalising further MED3000 partnering and license agreements in additional regions, particularly where marketing approval is near-to-medium term.
Looking at other projects, the drug developer recently appointed advisors to explore commercial opportunities for CBD100, which uses its proprietary transdermal technology DermaSys to deliver Cannabidiol through the skin.
It is also exploring the feasibility of a clinical study that would satisfy the Phase 3 requirements for both UK and US marketing approval for TPR100, which uses DermaSys to deliver diclofenac for the pain and inflammation associated with sprains, strains and bruises and soft tissue rheumatism.
In the year to December 31, net loss came in at GBP2.41mln against a loss of GBP8.92mln in 2019.
“Futura has achieved major milestones in terms of securing partnering for the development and commercialisation of MED3000 in China and South East Asia in a deal structured to capture significant long-term value, as well as the EU Notified Body’s recommendation to certificate MED3000 for Class 2B approval as a medical device for ED treatment under the European Medical Device Regulations,” said chief executive James Barder in a release.
Analysts at house broker Liberum said they expect the shares to further re-rate as management crystallises the value of MED3000 over the coming 6-18 months.
“The shares have responded, up 261% year to date. However, we believe there are further significant catalysts to come including potential EU and RoW licensing deals, regulatory approval in smaller Asian markets and the start of the all-important US confirmatory study in the second half,” they commented.
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