Futura Medical Regulatory News (FUM)

Futura Medical Presents Data on MED2005 for the Treatment of Erectile Dysfunction at the 19th Annual Fall Scientific Meeting of Sexual Medicine Society of North America (SMSNA)

9 November 2018

Futura Medical plc (AIM: FUM) (the "Company"), a pharmaceutical company developing a portfolio of innovative products for sexual health and pain relief, today announces that it will be presenting data on its DermaSys® drug delivery technology and lead product MED20051, a topical glyceryl trinitrate ("GTN") gel for the treatment of erectile dysfunction ("ED"), at the 19th Annual Fall Scientific Meeting of SMSNA, on 8-11 November 2018 at the Loews Miami Beach Hotel, Miami, Florida USA.

Tim Holland, Director of Clinical Development at Futura Medical, will give an oral presentation (#155) entitled "Pharmacokinetics (PK) of MED2005, a Topical Glyceryl Trinitrate Gel for the Treatment of Erectile Dysfunction2" on Friday 9 November at 16:25 EST. The presentation will be part of the 'Erectile Dysfunction (Medical) - Moderated Posters' session.

The PK data to be presented demonstrate that MED2005 has been shown to have a rapid absorption, good bioavailability and an acceptable safety profile at doses higher than 0.2% studied in the previously reported Phase 2 clinical study ("FM53"). In addition, the PK study demonstrated similar or lower bioavailability of GTN when administered via MED2005 compared with Nitrostat® at doses 0.2%, 0.4%, and 0.6% GTN.

Results also demonstrated that plasma concentrations of GTN and its two major metabolites increased proportionally with increasing MED2005 dosage. The highly encouraging results build on the data from FM53 that demonstrated statistically significant benefit over placebo in humans using the internationally accepted IIEF-EF trial endpoints. This supports the Company's strong belief that the higher dose forms of MED2005 should improve efficacy with an acceptable safety profile and meet US FDA's requirements for the simplified 505(b)2 regulatory pathway. Results of FM53 were published in a peer reviewed paper in The Journal of Sexual Medicine in February 2018.

James Barder, Chief Executive Officer of Futura Medical, said: "We are very pleased to share in more detail these meaningful findings on our lead programme MED2005 with the medical community at this prestigious meeting. These PK data demonstrate the potential of MED2005 as a safe and fast-acting erectile dysfunction treatment with a favourable side effect profile, a key differentiator to other ED products on the market."

Futura recently announced that the first patient has been enrolled in the first European Phase 3 study, ("FM57"), of MED2005 that will recruit approximately 1,000 patients with mild, moderate or severe ED

ENDS

1Holland, T1; Mason, R2; Terrill, P3; Blakey, G4; James, K1

1: Futura Medical Developments Limited; 2: RSM Medical Services Limited; 3: Cytel UK; 4: Consult2deliver

The study was funded by Futura Medical.

2 MED2005 is the codename used by Futura for the 'locked' formulation for use in ongoing clinical trials. MED2002 is the codename used by Futura for all proprietary formulations of GTN.

For further information please contact:

Futura Medical plc James Barder, Chief ExecutiveAngela Hildreth, Finance Director and COO

Email: Investor.relations@futuramedical.comTel: +44 (0) 1483 685 670

Nominated Adviser and Broker:N+1 SingerAubrey Powell/ Ben Farrow (Corporate Finance)

Tom Salvesen/ Mia Gardner (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) 20 3950 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

About MED2005: Eroxon® - Topical treatment for erectile dysfunction (ED)

MED2005, which uses Futura's DermaSys® drug delivery system, is the development name for its topical glyceryl trinitrate ("GTN") gel. It has the potential to be a highly differentiated therapy for the treatment of men with ED, especially mild to moderate ED. MED2005's rapid onset of action means that it has the potential to become the world's fastest-acting treatment for ED, with a speed of onset of around five minutes. Viagra® and Cialis® which dominate the existing on-market ED therapies are taken orally and do not take effect for at least 30 minutes and typically one hour or more1. Speed of onset and method of administration of MED2005 also help restore spontaneity and intimacy. Importantly, MED2005 may also be appropriate for ED sufferers on nitrates and other drugs that are contraindicated for 5 use with phosphodiesterase-5-inhibitors ("PDE5Is") such as Viagra® and Cialis® and other existing oral ED treatments.

Note 1: US patient information for Viagra® and Cialis®

Forward looking statements

This announcement may contain certain forward-looking statements. Whilst the Directors believe all such statements to have been fairly made on reasonable assumptions, there can be no guarantee that any of them are accurate or that all relevant considerations have been included in the directors' assumptions; accordingly, no reliance whatsoever should be placed upon the accuracy of such statements, all of which are for illustrative purposes only, are based solely upon historic financial and other trends and information, including third party estimates, and may be subject to further verification. These forward-looking statements are based on management's current expectations as of the date of this announcement and should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release. These statements involve known and unknown risks, uncertainties and other important factors that may cause the Company's actual results, performance or achievements to be materially different from any expectations expressed or implied by the forward-looking statements. These and other important factors, under the heading "Risk Factors" in the Company's recently issued circular to shareholders in relation to its proposed fundraising (available at https://www.futuramedical.com/archive/2018-GM-Notice-121118.pdf) and under the heading "Principal risks and uncertainties" in the Company's last annual report, could cause actual results to differ materially from those indicated by the forward-looking statements made in this announcement. Neither the Company nor its Directors makes any representation or warranty in respect of the accuracy, completeness or verification of the contents of this announcement.

James Barder, CEO, and Angela Hildreth, FD & COO arranged for the release of this announcement on behalf of the Company.