Futura Medical Regulatory News (FUM)

28 June 2021

Futura Medical plc

("Futura" or the "Company")

AGM Statement

· MED3000 CE mark approved for marketing in Europe and UK

· Commercialisation of MED3000 continues at pace with China and South East Asia partnered and discussions for other countries ongoing

· Regulatory submission to US FDA continues on track

Futura Medical plc (AIM: FUM) ("Futura" or the "Company"), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology and currently focused on sexual health and pain, is pleased to announce that John Clarke, Non-Executive Chairman, will provide the following update at the Company's Annual General Meeting ("AGM") which is being held at 10:00 am BST later today.

MED3000 - a topical treatment for Erectile Dysfunction ("ED")

MED3000 has CE mark approval in Europe for treatment of ED in adult men. This paves the way for approval in many countries around the world, including in the Middle East, Africa, the Far East and Latin America, which are regions which allow "fast-track" review based on recognition of the CE mark.

For the US, planning and preparation activities such as active site recruitment are well underway for the start of FM71, the confirmatory study to be conducted prior to formal regulatory submission to FDA as a DeNovo Medical Device. Trial start is on schedule with first patient dosing expected Q3 2021.

Securing manufacturing capacity and flexibility to scale up production of MED3000 to meet projected demand is also a clear focus for the Board and management.

Futura's first licensing deal announced in Q1 was a joint collaboration agreement for China and South East Asia with 50/50 share of profits between Futura and its Asian partner designed to capture long term value for the Company.

These validating milestones are driving progress on active commercial discussions with potential licensing and marketing partners. Discussions are moving forward with a number of other parties for licensing rights for MED3000 in other regions and we continue to target concluding a number of deals in the coming months.

COVID-19

The impact of COVID-19 on the Company has been limited to date. The safety of our employees, third-party suppliers and partners remains our primary concern, and we have continued to follow the government guidance in regions in which we operate.

John Clarke, Chairman of Futura Medical, commented: "The licensing agreement and financing activities in H1 2021 have given the Company significant momentum. Futura is rapidly advancing MED3000, looking to capture long term value and working towards creating a Company with substantial revenue streams. We thank all our shareholders for supporting the Company as well as employees and partners for their commitment and hard work. MED3000 is a breakthrough treatment for erectile dysfunction (ED), approved in Europe as a medical device. We have a first, commercial agreement in place for China and South East Asia. Our outlook for further deals is optimistic and we look forward to updating the market on Futura's developments during the remainder of 2021. The team is laser-focused on preparation and execution of the confirmatory clinical study and the non-clinical study to finalise an OTC label for the regulatory submission for MED3000 in the US which the Company aims to achieve in 2022."

-ENDS-

For further information please contact:

Futura Medical plc

James Barder, Chief Executive

Angela Hildreth, Finance Director and COO

Email: Investor.relations@futuramedical.com 

Tel: +44 (0) 1483 685 670

www.Futuramedical.com

Nominated Adviser and Sole Broker:

Liberum

Richard Lindley/ Euan Brown/ Kane Collings

Tel: +44 (0) 20 3100 2000

For media enquiries please contact:

Optimum Strategic Communications

Mary Clark/ Eva Haas/ Hollie Vile

Email: futuramedical@optimumcomms.com

Tel: +44 (0) 20 3922 0900

About Futura Medical plc

Futura Medical plc (AIM: FUM), is a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® technology. Each DermaSys® formulation is separately patented and specifically tailored for the selected indication and application, as well as being optimised for clinical efficacy, safety, administration and patient convenience. The products are developed for the prescription and consumer healthcare markets as appropriate. Current therapeutic areas are sexual health, including erectile dysfunction, and pain relief. Development and commercialisation strategies are designed to maximise product differentiation and value creation whilst minimising risk. 

MED3000 is Futura's topical gel formulation that is a breakthrough treatment for erectile dysfunction (ED) through a unique evaporative mode of action. Futura has conducted a Phase 3 study using MED3000 in ED, referred to as "FM57". This was a 1,000 patient, dose-ranging, multi-centre, randomised, double blind, placebo-controlled, home use, parallel group study delivering highly statistically significant results compared to pre-treatment baseline, consistently meeting all co-primary endpoints of IIEF, SEP2 and SEP3 (internationally accepted clinical trial endpoints in ED) with over 60% of patients experiencing a clinically meaningful improvement in their ED. MED3000 also begins to work immediately in some patients, with 60% of patients seeing onset of their erection within 10 minutes of application. MED3000 is CE marked in Europe and the UK as a clinically proven topical treatment for adult men with erectile dysfunction.

Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange. www.futuramedical.com