Futura Medical : Interim results September 2021

FUTURA MEDICAL PLC 29 SEPTEMBER 2021

INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2021

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 its interim results for the six months ended 30 June 2021.

HIGHLIGHTS

Europe

• Significant progress made in Europe and the UK with the Company receiving its MDR EU Quality Management Certificate in April 2021, for placing MED3000 on the market as a Class 2B medical device also known as European "CE mark approval".
• Futura's breakthrough, topical gel formulation MED3000, will become the first pan-European topical treatment for erectile dysfunction ("ED") available without the need of a doctor's prescription ("OTC").

USA

• Further pre-submission meetings with the US Food and Drug Administration (FDA) held during the period to finalise the design of a small supplemental clinical trial (known as "FM71") to be conducted prior to formal regulatory submission as a DeNovo Medical Device and a Human Factors study required by FDA for OTC marketing approval of MED3000 in USA.
• In March 2021 the Company received official minutes from the FDA following the pre-submission meeting signifying agreement between FDA and Futura on the detailed clinical study design (protocol) for clinical study, FM71.

USA - Post period highlights

• In August 2021 Futura received final meeting minutes from a July 2021 pre-submission meeting with FDA that also confirmed the detail of the work required for OTC classification in the USA for MED3000.

• 1. To enable OTC classification a non-clinical, Human Factors Study will test the ability of subjects to self-diagnose their ED, correctly select the product based on label information and test their ability to correctly use the product without supervision of a doctor. The FDA has asked for a minimum of 15 subjects to complete the study.
• On 14 September 2021 the first patient was enrolled in the FM71 confirmatory clinical study.

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• Both the Human Factors and FM71 studies are now progressing in line with plans to submit MED3000 for US regulatory approval as a DeNovo medical device for ED treatment, with OTC classification by end Q3 2022.
• US marketing authorisation remains on track for potential approval of MED3000 in Q1 2023.

Commercial

• Futura aims to create a network of licensing and distribution partners with strength in brand building, pharmaceutical credibility and regional infrastructure and marketing expertise for long-term distribution of MED3000 across the globe.
• Joint collaboration agreement for China and South East (SE) Asia with 50/50 share of profits signed in March 2021. Discussions are being held with the Chinese regulator, the National Medical Products Administration (NMPA), to clarify scope of clinical work required to gain approval in China. Expected additional R&D costs of up to £4 million are being fully met by our partner. In a number of additional SE Asian markets Futura is also working on nearer term regulatory submissions.

Commercial - Post period highlights

• In August 2021 Futura entered into a licensing agreement with m8 Pharmaceuticals, Inc ("m8"), a specialty biopharmaceutical company focused on commercialisation in Latin America, for the rights to exclusively develop and commercialise the Company's MED3000, in Brazil and Mexico.
• In September 2021 Futura signed a licensing agreement with Labatec Pharma ("Labatec"), a Swiss-based specialty pharma Company with expertise in commercialisation in Europe and the Middle East North
  Africa ("MENA") region for exclusive rights to commercialise MED3000 in the Gulf Co-operation ("GCC") region, Jordan, Lebanon and Iraq.
• MED3000 manufacturing capabilities expanded in August with addition of a new third party, FDA, EMA and UK approved manufacturer as Futura strengthens resources in the build up towards product launches in 2022.

Financial highlights

• In May 2021 the Company conducted a £12 million (net) fundraise including retail offer.
• £1.59 million net loss in the period (30 June 2020: net loss £1.06 million).
• Cash resources of £12.76 million at 30 June 2021 (30 June 2020: £2.62 million).
• Current cash runway extends beyond expected initial MED3000 launches in 2022 and expected US regulatory approval.

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.

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James Barder, Chief Executive of Futura, commented: "Futura is in the late stages of regulatory procedures to bring MED3000 to market for erectile dysfunction in the key US market and is targeting US submission by end Q3 2022. After CE mark approval by the European regulator the Company is preparing for first product launches during 2022 not just in Europe but also countries where recognition of the CE mark may allow "fast- track" review, importantly making a highly differentiated treatment option accessible and available to patients without a doctor's prescription.

We are furthermore proud of having achieved important milestones in terms of securing partnering for the development and commercialisation of MED3000 in additional major markets for erectile dysfunction, including China, South East Asia, Latin America, the Gulf and Middle East in deals structured to capture significant long-term value, as well as the EU Notified Body's recommendation to certificate MED3000 for Class 2B approval as a medical device for ED treatment under the European Medical Device Regulations."

"The Company is well positioned to deliver further positive news through the remainder of 2021 and in 2022 as we drive towards MED3000 2022 product launches, a global product franchise and our objective to deliver a long-term and sustainable revenue for shareholders."

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OPERATIONAL REVIEW - "SIGNIFICANT PROGRESS IN MED3000 COMMERCIALISATION AS PREPARATIONS MADE FOR LAUNCHES STARTING 2022"

As an innovative, specialist R&D company, Futura's strategy is to leverage its DermaSys® transdermal delivery technology to bring innovative products to market in sexual health and pain, bringing new treatment options to patients particularly in areas of significant unmet need.

DermaSys® - Our proprietary patented transdermal technology platform

Futura's unique patented technology DermaSys® is designed to deliver clinically proven effective medical treatments via the skin.

DermaSys® is a versatile and bespoke technology. Each product gel is uniquely formulated using the DermaSys® platform with volatile solvent component formulations tailored for each product to suit the specific therapeutic indication and desired speed of onset and duration of action. Such targeted delivery offers an optimised profile in terms of dose, onset time and duration of effect as well as an improved safety profile reducing the risk of side effects. Each product is formulated to maximise its benefits for patients and consumers. Each new unique formulation offers the opportunity for additional patent applications and potential patent protection.

MED3000 - Topical gel for erectile dysfunction ("ED")

MED3000 is a formulation of the proprietary technology DermaSys®, for the treatment of ED. MED3000 has the potential to be a highly differentiated product by addressing significant unmet needs, across all patient severities in the multi-billion dollar ED market1, which include rapid speed of onset enabling spontaneity for both partners, significant clinical benefits alongside excellent safety and low side effects and no interactions with alcohol or food as well as providing a potential treatment option for patients contra-indicated from using existing ED therapies. It has the potential to become the first globally available, clinically proven, over the counter ("OTC") treatment for erectile dysfunction and has already been approved as the first pan- European topical treatment for ED available without the need of a doctor's prescription.

The prevalence of ED disrupts the lives of at least 1 in 5 men globally2, with around 23 million men in the US and 20 million men in the UK, France, Italy and Germany. Whereas there has been little innovation in ED treatments for over ten years and many patients continue to suffer dissatisfaction with existing treatments the market continues to evolve especially within the USA with the advent of subscription services such as For Hims and Get Roman, and also in the UK with Numan which offers a branded concierge service for ED prescription medicines online. These subscription services offer a monthly subscription fee, typically in the region of US$50 in return for a doctor's consultation and ten generic 50mg sildenafil tablets per month. This increased affordability of around US$5 per tablet (to the end user) is driving volumes especially in the USA which have increased by 85% between 2018 and 20201.

MED3000 - Medical device regulatory pathways

Europe

In April 2021 the Company announced that it received its MDR EU Quality Management Certificate for the placing on the market of a Class 2B medical device known as MED3000 ("CE mark approval"). Futura's

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breakthrough, fast acting topical gel formulation MED3000, is the first clinically proven, pan-European topical treatment for adult men with ED available without a doctor's prescription ("OTC").

Studies have shown MED3000 to be an extremely effective treatment for ED with an excellent safety profile. MED3000 has a unique evaporative mode of action which the Company believes stimulates nerve endings in the glans penis to cause an erection. MED3000 helps men get an erection within 10 minutes, substantially faster than on-demand oral tablet phosphodiesterase-5 inhibitors (PDE5i's), with significant benefits for spontaneous rather than pre-planned sexual intercourse.

The CE mark approval of MED3000 from the EU Notified Body paves the way for approval in many countries around the world, including in the Middle East, Africa and the Far East regions which allow "fast-track" review based on recognition of the EU CE mark. Due to post-Brexit arrangements, the EU CE mark can be used to market the product in Great Britain until 30 June 2023 by which time a specific UKCA mark has to be obtained. This will be a streamlined process since it is understood the UK application can bridge to the EU approval.

USA

FDA's guidance documents indicate that their preference is to adopt an interactive and iterative approach to data requirements through pre-submission meetings with sponsors. According to FDA, careful considerations of their feedback may improve the quality of subsequent submissions, shorten total review times and facilitate the development process for new devices. Thus, multiple productive and positive pre-submission meetings were held during 2020 and 2021 to discuss existing Phase 3 clinical data, pathway to OTC status and any additional clinical and non-clinical requirements.

Summarising US activity to date in 2021

In March 2021 Futura announced that it received official minutes from the US Food and Drug Administration (FDA) for MED3000, following its Pre-Submission Meeting on 1 February 2021 confirming agreed design for the confirmatory FM71 clinical trial.

In July 2021 Futura met with the FDA for a pre-submission meeting to define and confirm the detail of the work required for OTC classification in the USA for MED3000. This was confirmed when final meeting minutes were issued in August 2021. The short, non-clinical, "Human Factors" study will test the ability of subjects to self-diagnose their ED, correctly select the product based on label information and test their ability to correctly use the product without supervision of a doctor. The FDA has asked for a minimum of 15 subjects to complete the study.

On 15 September 2021 Futura announced that the first patient had entered pre-screening in FM71. The Human Factors study is running in parallel with FM71 to enable planned regulatory submission by end of Q3 2022. Therefore, US OTC marketing authorisation remains on track for potential approval of MED3000 in Q1 2023.

US confirmatory clinical study, FM71

FM71 is designed as a Phase 3, multicentre, comparative, randomised, open-label, home use, parallel group study to provide supplementary efficacy data to the previously reported FM57 study with a "least burdensome" approach and modest cost, estimated to be £3 million. Whilst the overall design is similar to that of the previous large Phase 3 FM57 study that recruited approximately 1,000 patients, no placebo (sham) cohort is required, hence the study is relatively smaller in size with approximately 100 patients. The recruited patients will include those suffering from mild, moderate or severe ED, using either MED3000 or tadalafil 5mg (50 subjects per group) and will also include 20 African American patients (from a US medical centre)

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