4 November 2024

Futura Medical plc

("Futura" or the "Company")

Encouraging New Product Development Pipeline Results

Futura Medical plc (AIM: FUM), the consumer healthcare company behind Eroxon^®, that specialises in the development and global commercialisation of innovative and clinically proven sexual health products, is pleased to provide an update on two successfully completed proof of concept studies in its new product development pipeline for the treatment of sexual dysfunction in men and women.

One of the Company's strategic priorities is to broaden its product range, leveraging its innovative and experienced R&D capability whilst being mindful of costs and focusing on return on investment for shareholders. As disclosed at the time of Futura's interim results on 10 September 2024, proof of concept studies were being undertaken and, following their successful completion, the Company is now in a position to provide further detail on two new products: WSD4000 and Eroxon^® Intense.

WSD4000 is a topical treatment designed for sexual dysfunction in women. Currently, no regulatory approved topical treatment for sexual dysfunction in women is available over the counter. WSD4000 has the potential to be an effective, breakthrough treatment for the common symptoms associated with sexual dysfunction, such as lack of desire, arousal and lubrication.

Eroxon^® Intense provides a potential range extension of the current Eroxon^® product and acts as an additional treatment option for erectile dysfunction, helping those men that may prefer a stronger sensation from Eroxon^®.

WSD4000 - for the treatment of sexual dysfunction in women

Between 40% and 50% of women experience at least one symptom of sexual dysfunction¹, with frequency of symptoms increasing after menopause, yet women remain chronically underserved. Existing prescription treatments offer a poor benefit-risk profile and fail to meet the needs of many women.

In an initial single-blind randomised crossover study set up by Futura, 16 female subjects blind tested three gel formulations in a clinic. The study tested one application of each gel with 40% of women and 63% of post-menopausal women reporting feelings of arousal after using the preferred gel formulation. Following this initial proof of concept study, the next stage of development is to mimic a "real world" situation in a home user study with 60 female subjects and multiple product uses. This study is underway with the aim of being able to provide initial validation for the product with results expected during Q1 2025.

It was important to validate the product concept with the US FDA and take steps to define the full development program. Thus, a first pre-submission meeting with FDA was conducted with a successful outcome. The official minutes of the FDA meeting confirmed the potential OTC² status of WSD4000 and a further meeting with the FDA is planned to  discuss the pivotal clinical study design following "least burdensome" principles. 

A new patent for WSD4000 was filed in February 2024, with the potential for further filings based on the outcomes of the studies. The innovation behind WSD4000 falls outside of existing commercial partner agreements for Eroxon^®.

The commercialisation strategy for WSD4000 will be determined by the Board following the completion of the home user study, and evaluation of market research commissioned by the Company that it expects will complete by early 2025. Discussions with potential commercial partners are ongoing.

Eroxon^® Intense - for strong sustained erections

Marketing experience with Eroxon has shown that whilst many men are satisfied with the current sensorial effect of the product, some men would prefer a stronger sensation. Eroxon^® Intense will help those men, thereby broadening the existing Eroxon^® range.

In a single-blind randomised crossover design study, 16 male subjects blind tested three enhanced formulations compared with Eroxon^®. 67% of the men experienced greater sensorial sensitivity on the preferred formulation compared to Eroxon^®. A preferred enhanced formulation with a favourable side effect profile has now been selected for further consumer testing during H1 2025, with regulatory approval in the EU & USA expected by the end of 2025.

The Company's commercial partners have shown strong interest for new variants beyond the original Eroxon^® product to expand the product range as they seek to build out the sexual health category within their own businesses. Therefore, an additional treatment option for erectile dysfunction that is aimed at helping the cohort of men that may prefer a stronger sensation from Eroxon^® is commercially attractive to support users' needs as well as commercial partners' strategic ambitions. Eroxon^® Intense will be covered under Futura's existing intellectual property.

Costs associated with the completion of the development of Eroxon^® Intense and WSD4000's initial development costs, including the home user study, are expected to be covered by the Company's existing R&D budget, inclusive of any contributions from commercial partners. Therefore, guidance around costs for FY2024 and FY2025 remain unchanged.

James Barder, Chief Executive Officer, commented:

"I am delighted to announce that our highly experienced R&D team has wasted no time in focusing on developing exciting new innovation within the OTC sexual health area. Having successfully developed, commercialised and signed world class partnerships for our first product, Eroxon^®, we are excited to announce the next phase of our NPD roadmap.

"We have already made significant strides following the launch of Eroxon^® internationally, including in the US in October 2024, delivering our maiden profit in FY24. In a prudent manner, we are now looking to expand our range especially within the underserved clinically proven treatments for women with sexual dysfunction, whilst continuing to focus on the rollout of Eroxon^® across various geographical markets."

1.   Source: McCabe MP, Sharlip ID, Lewis R, Atalla E, Balon R etal. Incidence and Prevalence of Sexual Dysfunction in Women and Men: A Consensus Statement from the Fourth International Consultation on Sexual Medicine 2015. J Sex Med. 2016 Feb;13(2):144-52

2.   OTC - over the counter, not requiring a doctor's prescription

The information communicated in this announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No. 596/2014 as amended by the Market Abuse (Amendment) (EU Exit) Regulations 2019.

Contacts:

Notes to Editors:

Futura Medical plc (AIM: FUM) is the developer of innovative sexual health products, including lead product Eroxon^®. Our core strength lies in our research, development and commercialisation of topically delivered gel formulations in sexual health products.

Eroxon^®, Futura's clinically proven lead product, has been developed for the treatment of Erectile Dysfunction ("ED"). The highly differentiated product, which is the only topical gel treatment for ED available over the counter and helps men get an erection in ten minutes, addresses significant unmet needs in the ED market.

ED impacts 1 in 5 men globally across all adult age brackets, with approximately half of all men over 40 experiencing ED and 25% of all new diagnoses being in men under 40.

Futura has distribution partners in place in a number of major consumer markets including Haleon in the US, the largest market for ED in the world, and Cooper Consumer Health in Europe. Eroxon^® has been nominated for a number of healthcare industry awards and has won two to-date.