10 April 2019


Sustained Progress made in 2018

Futura Medical plc (AIM: FUM), the pharmaceutical company developing a portfolio of innovative products for sexual health and pain, based on its proprietary, transdermal DermaSys® drug delivery technology is pleased to announce its preliminary results for the year ended 31 December 2018.

Highlights

 

Operational highlights

  • Following an extensive strategic review which was announced in September 2018, Futura has focused on maximising value in its development pipeline and product portfolio addressing two large market categories, sexual health and pain. The lead priorities are MED2005, its innovative topical treatment for erectile dysfunction (ED), and its pain portfolio including TPR100, a topical non-steroidal anti-inflammatory drug. Futura's core objectives are to:
    • complete the development of MED2005, currently in Phase 3 clinical trial, and
    • further realise value from the pain portfolio.
  • In February 2018, Angela Hildreth joined Futura in the role of Finance Director, Chief Operating Officer and Board Director.

 

MED2005 - Topical glyceryl trinitrate (GTN) formulation for erectile dysfunction

  • Publication of positive Phase 2a, "FM53" data, in peer-reviewed Journal of Sexual Medicine in February 2018.
  • First Phase 3 study, "FM57", commenced in October 2018.
  • Positive results from pharmacokinetic ("PK") study presented at the annual scientific meeting of the Sexual Medicine Society of North America (SMSNA) in November 2018, demonstrating safety and dose related absorption.
  • First advisory panel meeting held with US key opinion leaders (KOLs) at the SMSNA meeting in November 2018. KOL 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.

 

MED2005 - Post year end

  • Data presented at the European Society of Sexual Medicine (ESSM) congress in February 2019, including:
    • Positive Phase 2a and Pharmacokinetic data
    • In vitro impedance testing (concluded late 2018) which further supports the safety profile for male patients and their sexual partners.
  • Second advisory panel held at ESSM in February 2019 with prominent European KOLs to discuss data and the on-going development and educational programme. As with US KOL peers, physician reaction was very positive.
  • R&D event held in London in February 2019 including a presentation from Professor David Ralph, a world leading expert in erectile dysfunction and male infertility and Chair of the Futura Medical European Advisory Panel.

 

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

  • Marketing authorisation application by UK commercialisation partner, Thornton & Ross (a subsidiary of STADA AG) submitted to the UK Medicines and Healthcare products Regulatory Agency (MHRA) in July 2018.
  • Ongoing commercial discussions with several potential distribution partners for other territories. Any further licensing deals are expected to be after UK regulatory approval.

 

TPR100 - Post year end

  • Supporting Thornton & Ross on responses to initial MHRA feedback received in February 2019.

 

Financial highlights

  • £5.85 million raised in November 2018 to progress MED2005 through Phase 3 "FM57" study in erectile dysfunction.
  • £5.89 million net loss in the period (31 Dec 2017: net loss £3.90 million).
  • Cash resources of £9.16 million at 31 December 2018 (31 December 2017: £8.36 million).

 

James Barder, Chief Executive of Futura, commented: "2018 was a significant year of progress for Futura, with the commencement of enrolment of patients into our first Phase 3 trial with MED2005. The trial is progressing as planned, and we look forward to Phase 3 headline data by end 2019. During the year, in parallel to the clinical studies, our team has engaged with a number of eminent experts in the field of erectile dysfunction in both Europe and the US to discuss and gain valuable and positive feedback on the on-going development and educational programme for MED2005.

The funding secured in 2018 ensures that Futura has sufficient resources to complete and deliver the Phase 3 top line data by the end of 2019 - which the Board believes will be a major value inflection point for the Company."

 

Analyst meeting and webcast

The Executive Team will host a presentation at 10am (BST), 10 April 2019, for analysts at the office of N+1 Singer at 1 Bartholomew Lane, London EC2N 2AX.

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: Investor.relations@futuramedical.com
Tel: +44 (0) 1483 685 670

Nominated Adviser and Broker:

N+1 Singer
Aubrey Powell/ Ben Farrow (Corporate Finance)
Mia Gardner / Tom Salvesen (Corporate Broking)
Tel: +44 (0) 20 7496 3000

For media enquiries please contact:

Optimum Strategic Communications
Mary Clark/ Hollie Vile/ Ellie Blackwell
Email: futuramedical@optimumcomms.com
Tel: +44 (0) 203 950 9144

 

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.

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