Futura Medical : Interim Results for the Six Months 30 June 2019

11 September 2019

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 currently focused on sexual health and pain, is pleased to announce its interim results for the six months ended 30 June 2019.

Highlights

MED2005 ­ Topical glyceryl trinitrate (GTN) formulation for erectile dysfunction

• Patient recruitment completed in June 2019 for the MED2005 first European Phase 3 study 'FM57'. This study is on track to deliver headline efficacy and safety data by the end of 2019. Patient recruitment was completed in June 2019 and at the end of August over 500 patients had completed the 12 week double-blind phase of the study with 80% of these patients having elected to continue into the open label extension to study long term safety of the highest dose.
• Planning for a second, confirmatory Phase 3 study for MED2005 is underway.
• Positive data to support safety in sexual partners provided at the European Society of Sexual Medicine (ESSM) congress in February 2019, including a review of safety data from the Phase 2a study, pharmacokinetic study and in-vitro impedance data.
• Second advisory panel held at ESSM in Slovenia in February 2019 with prominent European key opinion leaders (KOLs) to review the data and discuss the on-going development and educational programme. As with US KOLs, their reaction to the therapeutic potential for MED2005 in erectile dysfunction and its areas of differentiation as well as the ongoing clinical programme was highly positive reflecting the limited amount of innovation in the sector for over ten years.

TPR100 ­ Topical non-steroidal anti-inflammatory for the pain and inflammation associated with sprains, strains and bruises and soft tissue rheumatism

• UK partner Thornton & Ross (a subsidiary of STADA AG) received feedback from UK Medicines and Healthcare products Regulatory Agency (MHRA) in February 2019 requiring additional laboratory work to be conducted to support the UK filing. This work is progressing, and we expect to respond in Q1 2020 within the timelines agreed with the MHRA.
• Ongoing commercial discussions with several potential distribution partners for other territories. Any further licensing deals are expected to be after UK regulatory approval.

CBD100 - Joint Venture Collaboration on optimised topical delivery of Cannabidiol

• Joint venture collaboration with CBDerma Technology Limited to explore the application of DermaSys® for optimised delivery of Cannabidiol through the skin to explore a number of disease states including pain relief. The initial joint venture development costs are expected to be in the region of $1 million. Any Intellectual Property will be jointly owned.

Financial highlights

• £4.46 million net loss in the period (30 June 2018: net loss £1.95 million).
• Cash resources of £5.63 million at 30 June 2019 (30 June 2018: £6.03 million).
• R&D tax credits of £1.36 million for year ending 2018 received in August (Year ending 2017: £0.94 million)

James Barder, Chief Executive of Futura, commented: 'We continue to make good progress in the development and commercialisation of our pipeline of product opportunities. We are pleased to have completed recruitment for the double-blind, clinical efficacy of the first European Phase 3 study of MED2005. Most patients have elected to continue into the open-label, Phase 3, safety stage in which all patients are on the highest dose of MED2005. We look forward to Phase 3 headline data by the end of the year. Engagement with eminent experts in the field of erectile dysfunction continues in both Europe and the US to increase awareness as well as with potential commercial partners in advance of Phase 3 results which remain our key priority to deliver on by the end of 2019.'

Analyst meeting and webcast
The Executive Team will host a presentation at 10am (BST), 11 September 2019, for analysts at the office of Liberum Capital at 25 Ropemaker Street, London, EC2Y 9LY.

Analysts wishing to attend the presentation should register their interest by emailing [e-mail].

Following the results meeting, a webcast of the presentation will also be made available within the Investor Centre section of the Futura company website at www.futuramedical.com.

The full results are available to download in PDF format.

For further information please contact:
Futura Medical plc
James Barder, Chief Executive
Angela Hildreth, Finance Director and COO
Email: [e-mail]
Tel: [phone]

Nominated Adviser and Sole Broker:
Liberum
Bidhi Bhoma/ Euan Brown/ Kane Collings
Tel: [phone]

For media enquiries please contact:
Optimum Strategic Communications
Mary Clark/ Eva Haas/ Hollie Vile
Email: [e-mail]
Tel: [phone]

Notes to editors:

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® drug delivery technology. These products are optimised for clinical efficacy, safety, administration and patient convenience and 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.

The first European Phase 3 study for MED2005, referred to as 'FM57', is a 1,000 patient, dose-ranging, multi-centre, randomised, double blind, placebo-controlled, home use, parallel group study of MED2005 0.2%, 0.4% and 0.6% Glyceryl Trinitrate for the treatment of erectile dysfunction with a 450 patient open label extension. FM57 is progressing on track, with headline data expected by the end of 2019.

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