Interim Results for the six months ended 30 June 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.
- Operational Review
- Statement of Comprehensive loss
- Consolidated Statement of Changes in Equity
- Consolidated Statement of Financial Position
- Consolidated Statement of Cash Flows
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.
- £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)
JamesBarder, 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 email@example.com.
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.
MED2005 - Topical gel for erectile dysfunction ("ED")
Futura's lead product MED2005 is a topical glyceryl trinitrate (GTN) gel for the treatment of erectile dysfunction (ED). MED2005 has the potential to be a highly differentiated therapy, especially for mild to moderate ED. In a Phase 2a study, MED2005 was shown to have a fast onset of action (5-10 minutes) and rapid clearance. MED2005 has the potential to be the fastest-acting ED treatment available.
Erectile dysfunction disrupts the lives of at least 1 in 5 men globally1, affecting the sexual and emotional health of around 27 million men and their partners in the USA alone. There has been little innovation in ED treatments for over ten years and many patients continue to suffer dissatisfaction with existing treatments especially those looking for a fast-acting treatment that can form part of sexual foreplay or those contraindicated from using existing therapies2.
Recent focus group research conducted by Futura in the UK on pre and post-menopausal women with partners with erectile dysfunction showed strong interest in MED2005 and its unique attributes. In particular it highlighted the perceived benefit of MED2005 providing a shared sexual experience with the potential to take the responsibility of treatment away from their male partner alone towards a solution that is embraced by the couple together. KOLs have consistently said treating the couple is more effective than treating the individual.
With an independently assessed market potential of over $1 billion as a prescription treatment and subsequently over the counter (OTC) treatment3, MED2005 is Futura's lead asset and a key value creation opportunity.
Phase 3 clinical programme progressing well
"FM57" - First, European Phase 3
MED2005's first Phase 3 study, "FM57" completed patient recruitment in June 2019. The 1,000 patient study includes approximately 60 centres across Central and Eastern Europe. Futura remains on track to deliver first Phase 3 headline data by the end of 2019.
This Phase 3 study is a dose ranging, randomised, double blind, placebo controlled, home use, parallel group clinical trial and compares the efficacy of 0.2%, 0.4% and 0.6% GTN doses of MED2005 in mild, moderate and severe ED patients.
Following positive Phase 2a "FM53" data, we have confidence that the higher doses of 0.4% and 0.6% being studied in addition to the 0.2% dose will show improved efficacy across patients with mild, mild to moderate and moderate ED - which represent the large majority of ED sufferers throughout the world and the largest commercial opportunity. Severe ED patients, who often have the most medical complications as well as being the oldest men, are a difficult patient cohort to treat. This is further evidenced by the limited success of the existing ED treatments in this cohort. We therefore remain cautious over the potential benefit MED2005 will bring to severe patients. As the first Phase 3 includes patients of all ED severities, if reduced efficacy in severe ED patients occurs, it is not expected to compromise the overall success of the study.
KOLs in both US and EU have expressed strong interest in a locally acting, fast and safe new treatment for ED that particularly targets those younger patients with mild and mild to moderate ED where frequency of intercourse is generally high compared to those patients with moderate to severe ED.
As part of the Phase 3 programme, Futura is required by regulators to run an open label extension study for safety. After patients complete their 4-month trial period, they are invited to enter the open label extension study ("OLE") to assess safety at the highest dose (0.6% GTN) up to the required number of 450 patients. Of these patients 300 are to continue treatment for a further 6 months and 150 patients for a further 12 months. At the end of August 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. This OLE is a normal requirement of regulators for pharmaceutical products to provide additional reassurance on safety for longer term use of MED2005.
"FM59" - Second, confirmatory Phase 3
We anticipate patient enrolment to commence for "FM59", a second, confirmatory Phase 3 study for MED2005 in H1 2020.
This study will incorporate a US patient cohort and we will be shortly filing protocols and an Investigational New Drug Application (IND) in the US. The protocols for this study will be the same as for "FM57" initially but will be informed by the receipt and analysis of the first Phase 3 data and adapted accordingly, if necessary, via regulatory amendments. The second Phase 3 will be a placebo controlled, parallel group study and will compare the efficacy of two GTN doses of MED2005, shown to be optimal in the first Phase 3 trial, in a smaller patient cohort of around 700 patients. The Company is currently undertaking pre-recruitment start-up activities in order to commence patient enrolment in H1 2020.
Completion of the second, confirmatory Phase 3 study, expected by the end of 2020, is subject to funding and positive results from "FM57", the first European Phase 3 trial. Any financing is expected to depend on the strength of the results in FM57. In anticipation of this, the Board is therefore exploring both non-dilutory and dilutory funding options and intends to place the Company in a position of strength to continue capitalising on product development and for negotiating any out-licensing agreements for MED2005.
It is usual for two Phase 3 studies to be required for regulatory filing. However, depending on data from the first European Phase 3 study, Futura may explore filing MED2005 with regulatory bodies in Europe with one Phase 3 study which could occur during H2 2020. The US FDA has been clear that two studies are required, and US filing will await results from the second Phase 3 study.
Futura held a R&D analyst event 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. These activities and events organised by Futura are continuing to increase the awareness and credibility of the potential innovation that MED2005 brings within the treatment arena of ED to both the medical and pharmaceutical communities. A second US advisory board meeting has been arranged for October 2019 at the Sexual Medicine Society of North America Conference.
Discussions continue with a number of interested commercial partners for the out-licensing of MED2005 although the Company's main focus is to deliver Phase 3 headline data by the end of 2019 and prepare for the second smaller Phase 3 which is critical for US regulatory approval in order to bring MED2005's novel benefits to ED patients through the EU and US as soon as possible.
We believe MED2005 has the required efficacy, speed of onset and favourable safety profile consistent with use as a prescription therapy as well as the potential to be an over-the-counter therapy.
MED2005 Intellectual Property
MED2005's current patent protection runs until August 2028 in the USA and August 2025 in Europe. In August 2018 Futura filed a Patent Co-operation Treaty (PCT) patent filing which is expected to extend patent life in many geographies to 2038. The PCT filing will be moving into the National filing phase in Q1 2020 in line with standard processes. This phase sets out specific, nominated countries under the Patent Co-operation Treaty which will adhere to the 2018 priority date through to 2037.
The EU also can provide up to ten year's data exclusivity and US up to three years from the date of regulatory approval subject to EU and FDA guidelines.
TPR100 - Topical gel for pain relief
TPR100 is a topical non-steroidal anti-inflammatory for the treatment of pain and inflammation associated with sprains, strains, bruises and soft tissue rheumatism.
TPR100 is partnered for manufacturing and distribution in the UK with Thornton & Ross, one of the UK's largest consumer healthcare companies and a subsidiary of STADA AG. In February 2019, the UK Medicines and Healthcare products Regulatory Agency (MHRA) responded to Thornton & Ross's marketing authorisation application filed in July 2018, raising a number of questions requiring additional laboratory work specifically around the permeation characteristics of TPR100 to be conducted. This work is progressing, and we expect Thornton & Ross to respond by the end of February 2020 within the timelines agreed with the MHRA.
The Company has received expressions of interest from a number of parties to enable Futura to expand the geographical reach of TPR100. Futura is awaiting regulatory authorisation in the UK before progressing further with these discussions.
CBD100 - Joint Venture Collaboration on optimised topical delivery of Cannabidiol
A joint venture collaboration has been signed with CBDerma Technology Limited to explore the application of Futura's advanced proprietary transdermal drug delivery technology, DermaSys® for delivery of Cannabidiol. All Intellectual Property will be owned jointly by the Company and CBDerma Technology Limited.
CBDerma Technology is a company that has been established and funded to specifically exploit the therapeutic potential of Cannabis. The company's management, backers and advisors have extensive knowledge, expertise and investments in plant derived product manufacturing. Cannabidiol is a major component of the cannabis plant and is generally regarded as non-addictive and non-psychoactive, making it ideal for consideration as a topically delivered molecule for local or regional (non-systemic) use.
Initial development costs are expected to be in the region of US$ 1 million and will cover all development costs incurred by the Company during the next 15 months in order to develop and optimise a DermaSys®- cannabidiol formulation as well as establish early ex-vivo proof of concept studies likely to include certain disease states most suited for local or regional (non-systemic) topical treatment such as pain relief. The Company does not expect this project's initial development to have any material impact on cashflow as Futura's financial share of the project will be delivered from its expertise and existing internal resources.
DermaSys® provides rapid and targeted local delivery of active pharmaceutical ingredients at therapeutic levels through the skin to the required site of action with a high level of safety. It is a versatile and bespoke technology that can be tailored to suit the specific active compound being used and the therapeutic indication. Each product is formulated to maximise its benefits for patients and consumers and can be developed for the prescription and consumer healthcare markets as appropriate.
Research and Development Costs
Research and Development costs for the six months ended 30 June 2019 were £4.74 million, compared to £1.65 million for the six months ended 30 June 2018. The increase of £3 million is attributable to the FM57 Phase 3 study which is running on time, within budget and expected to provide headline data in December 2019.
Administrative costs were £0.53 million for the six months ended 30 June 2019 compared to £0.86 million for the six months ended 30 June 2018 and were reflective of the Company's strategy to keep central costs lean and focus cash resources on delivering the R&D programme.
At the period end the Group held £5.63 million of cash with a further £1.36 million of R&D tax credit refund received after the period end, in August 2019. As has been previously discussed, the cash currently held by the Group will not be sufficient to complete the second Phase 3 study (FM59) which the Group intends to commence during 2020, assuming that the results of FM57 are positive. The Board is therefore exploring a number of funding options including non-dilutory and dilutory options and believe that the results of the FM57 trial will have a major impact on these funding options and the costs associated with them. Whilst there can be no guarantee that any of these opportunities will be successfully concluded, the Directors believe that it remains appropriate to prepare the financial statements on a going concern basis.
The tax credit of £0.8 million (2018: £0.6m) is an accrual for the expected R&D tax credit receivable for the six months ended 30 June 2019.
Post Period Events
The R&D tax credit relating to 2018 claim of £1.36 million was received in August 2019.
Futura now has the potential for a significant value inflection driven by MED2005 late stage clinical development. We look forward to headline data from the first Phase 3 study towards the end of 2019. We are excited to be moving closer to bringing an innovative, highly differentiated ED product to market that could help the many ED patients whose needs are not met by current treatments. In parallel we are managing the Company's resources prudently whilst planning and building for the future to further leverage our DermaSys® technology and products.
1 EMEA, Withdrawal assessment report for Viagra, 2008
2 50% of men discontinue treatment on PDE5s, reference Carvalheira J Sex Med. 2012 Sep;9(9):2361-9. Research from Decision Resources Group and Cello Health Consulting show that many patients are dissatisfied with their treatment. In the research from Cello, physicians stated that the main reason they see their patients switch to MED2005 is the speed of onset.
3 Based on external market assessments from market research conducted by Cello Health Consulting as a prescription product and Ipsos Group as an over the counter product.
6 months ended
6 months ended
|Research and development costs||(4,739,965)||(1,652,536)||(6,038,941)|
|Loss before tax||(5,261,115)||(2,509,239)||(7,238,912)|
|Total comprehensive loss for the periodattributable to owners of the parent company||(4,461,115)||(1,950,682)||(5,880,576)|
|Loss per share (pence)||5||(2.18p)||(1.61p)||(4.46p)|
|At 1 January 2018 - audited||241,392||44,671,396||1,152,165||(36,959,195)||9,105,758|
|Total comprehensive loss for the period||-||-||-||(1,950,682)||(1,950,682)|
|Shares issued during the period||620||92,380||-||-||93,000|
|At 30 June 2018 - unaudited||242,012||44,763,776||1,152,165||(38,806,413)||7,351,540|
|Total comprehensive loss for the period||-||-||-||(3,929,894)||(3,929,894)|
|Shares issued during the period||167,155||5,220,084||-||-||5,387,239|
|At 31 December 2018 - audited||409,167||49,983,860||1,152,165||(42,692,938)||8,852,254|
|Total comprehensive loss for the period||-||-||-||(4,461,115)||(4,461,115)|
|Shares issued during the period||154||19,130||-||-||19,284|
|At 30 June 2019 - unaudited||409,321||50,002,990||1,152,165||(47,112,329)||4,452,147|
|Plant and equipment||71,800||55,681||47,473|
|Total non-current assets||71,800||55,681||47,473|
|Trade and other receivables||6||122,887||152,049||306,408|
|Current tax asset||2,158,192||1,485,803||1,358,192|
|Cash and cash equivalents||7||5,626,792||6,025,174||9,157,916|
|Total current assets||7,915,651||7,733,439||10,830,296|
|Trade and other payables||(3,535,304)||(437,580)||(2,025,515)|
|Total net assets||4,452,147||7,351,540||8,852,254|
|Capital and reservesattributable to
owners of the parent company
|Cash flows from operating activities|
|Loss before tax||(5,261,115)||(2,509,239)||(7,238,912)|
|Loss on disposal of fixed assets||703|
|Share-based payment charge||41,724||103,464||146,833|
|Cash flows from operating activities before changes in working capital||(5,224,926)||(2,405,269)||(7,099,102)|
|Decrease in inventories||-||-||62,633|
|(Increase) / decrease in trade and other receivables||183,522||29,027||(125,332)|
|(Decrease) / increase in trade and other payables||1,509,788||(61,561)||1,526,375|
|Cash used in operations||(3,531,617)||(2,437,803)||(5,635,426)|
|Income tax received||-||-||927,391|
|Net cash used in operating activities||(3,531,617)||(2,437,803)||(4,708,035)|
|Cash flows from investing activities|
|Purchase of plant and equipment||(32,186)||(2,099)||(4,510)|
|Cash (absorbed) / generated by investing activities||(18,791)||7,330||(23,066)|
|Cash flows from financing activities|
|Issue of ordinary shares||19,284||93,000||5,943.421|
|Expenses paid in connection with share issues||-||-||(463,182)|
|Cash generated by financing activities||19,284||93,000||5,480,239|
|(Decrease) / increase in cash and cash equivalents||(3,531,124)||(2,337,472)||795,270|
|Cash and cash equivalents at beginning of period||9,157,916||8,362,646||8,362,646|
|Cash and cash equivalents at end of period||5,626,792||6,025,174||9,157,916|
The Notes to the Financial Statements are contained in the full results which is available to
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Page last updated: 11 September 2019