Futura Medical PLC (AIM:FUM, OTC:FAMDF) is set for another period of key news flow, according to Liberum Capital Markets.
The broker met with management ahead of today's annual general meeting at which shareholders will be regaled with a list of Futura's achievements in 2021, among them MED3000 receiving UKCA mark approval as a Class 2A medical device and the signing of five licensing agreements for MED3000.
MED3000 is Futura’s breakthrough rapid-acting topical gel formulation for the treatment of erectile dysfunction.
The company said it looks forward to further updates for shareholders during the remainder of 2022 as it prepares for the initial launches of MED3000, further commercial agreements and the anticipated US regulatory filing by the end of September 2022.
Patient recruitment for the FM71 study (a confirmatory study stipulated by the FDA) completed at the end of 2021 and the clinical study, including patient follow-up, is drawing to a close. The company remains on track to be able to disclose the results in early September, the statement said.
Liberum Capital Markets said the AGM statement reiterates the strategical progress management made this last year in commercialising MED3000.
"We met with management ahead of the AGM, and management have set the scene for another period of key news flow, fine-tuning expectations for data from the registration-enabling FM71 clinical study in the US in September 2022. This sets up a possible FDA approval by end of Q1 2023 unlocking a £250mln OTC opportunity. Our target price remains at 109p, representing over 3x upside based on the global value of MED3000," Liberum said.