TIDMFUM
RNS Number : 3017N
Futura Medical PLC
29 September 2021
For immediate release 29 September 2021
Futura Medical plc
("Futura" or "the Company")
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(R) 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 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 US Food and Drug Administration (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.
-- 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.
-- 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 GBP4
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 GBP12 million (net) fundraise including retail offer.
-- GBP1.59 million net loss in the period (30 June 2020: net loss GBP1.06 million).
-- Cash resources of GBP12.76 million at 30 June 2021 (30 June 2020: GBP2.62 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.
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."
Analyst meeting and webcast
The Executive Team will host a webcast of the presentation which
will be available within the Investor Centre section of the Futura
company website at www.futuramedical.com from 10 am BST on
Wednesday 29 September 2021. T he Company will provide an update on
the regulatory pathway of MED3000 in the US, manufacturing and
commercialisation progress.
Analysts wishing to speak to the Futura management team can
register their interest by emailing
futuramedical@optimumcomms.com.
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 Sole Broker:
Liberum
Richard Lindley/ Euan Brown/ Kane Collings
Tel: +44 (0) 203 100 2000
For media enquiries please contact:
Optimum Strategic Communications
Mary Clark/ Eva Haas/ Hollie Vile
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(R) technology. Each DermaSys(R)
formulation is separately patented and specifically tailored for
the selected indication and application, as well as being optimised
for clinical efficacy, safety, administration and patient
convenience. The products 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.
MED3000 is Futura's topical gel formulation that is a
breakthrough treatment for erectile dysfunction (ED) through a
unique evaporative mode of action. Futura has conducted a Phase 3
study using MED3000 in ED, referred to as "FM57". This was a 1,000
patient, dose-ranging, multi-centre, randomised, double blind,
placebo-controlled, home use, parallel group study delivering
highly statistically significant results compared to pre-treatment
baseline, consistently meeting all co-primary endpoints of IIEF,
SEP2 and SEP3 (internationally accepted clinical trial endpoints in
ED) with over 60% of patients experiencing a clinically meaningful
improvement in their ED. MED3000 also begins to work immediately in
some patients, with 60% of patients seeing onset of their erection
within 10 minutes of application. MED3000 is CE marked in Europe
and the UK as a clinically proven topical treatment for adult men
with erectile dysfunction.
Futura is based in Guildford, Surrey, and its shares trade on
the AIM market of the London Stock Exchange.
www.futuramedical.com
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(R) 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(R) - Our proprietary patented transdermal technology
platform
Futura's unique patented technology DermaSys(R) is designed to
deliver clinically proven effective medical treatments via the
skin.
DermaSys(R) is a versatile and bespoke technology. Each product
gel is uniquely formulated using the DermaSys(R) 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(R) , 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
market(1) , 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
globally(2) , 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 2020(1) .
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 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
GBP3 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) and 80 patients recruited from
Eastern Europe where sites include some of the same centres used in
the FM57 study.
FM71 will be a 7-month study (including 1 month to establish
baseline), studying 6-month (24 weeks) treatment duration versus
FM57 which was conducted over 3 months' treatment duration (12
weeks) to reassure the FDA that the efficacy does not diminish over
a longer period of time. It is Futura's belief that this is
unlikely as in the FM57 study efficacy improved from the first to
third month of patient use. Two co-primary endpoints will measure
the change from baseline, and whether this change is clinically
meaningful using the Rosen statistical method, a standard
assessment technique for measuring Patient Reported Outcomes. Both
these end points were measured in FM57 at 12 weeks and were met and
exceeded the stated criteria. Secondary endpoints include an agreed
measure of speed of onset, a key differentiating claim, where FM57
showed that 60% of subjects noticed an erection within 10
minutes.
The Company has agreed with the FDA to include tadalafil (the
active in Cialis(R) ) at the lowest approved dose for on-demand use
(5mg) for comparative purposes only on safety, speed of onset and
efficacy. Non-inferiority is not required to be shown.
MED3000 commercialisation
In early March 2021 Futura announced investment into the Company
and joint collaboration with Co-High Investment Management Limited
and certain subsidiaries of Atlantis Group to commercialise MED3000
in China and South East Asia. Futura also announced in August 2021
that it entered into a licensing agreement with m8 Pharmaceuticals
to commercialise MED3000 in Brazil and Mexico, swiftly followed in
September by a licensing agreement with Labatec Pharma ("Labatec")
for exclusive rights to commercialise MED3000 in the Gulf
Co-operation ("GCC") region, Jordan, Lebanon and Iraq.
Co-High licensing agreement - China and South East Asia
In March 2021 Futura entered into GBP1.5 million convertible
debt and GBP0.5 million of warrants financing transactions with HT
Riverwood Multi-Growth Fund ("Riverwood"), a fund managed by
Atlantis Investment Management Limited ("Atlantis"), which provided
the Company with GBP2 million in cash. These financial instruments
were respectively converted and exercised by Riverwood in March and
April 2021 and there are no further amounts outstanding to
Riverwood from Futura.
Atlantis is a 100% owned subsidiary of the Atlantis Group and
Co-High Investment Limited ("Co-High) is a 60% owned subsidiary of
the Atlantis Group. Ms Yang Liu, now Atlantis' Chairperson and
Chief Investment Officer, acquired the Atlantis Group in 2009.
Additionally, Futura entered into a licensing agreement with
Pride Century Ventures, a special purpose vehicle owned by Co-High
for the rights to exclusively develop and commercialise the
Company's topical, gel-based ED treatment MED3000, in China and
South East Asia (the "Region"). Co-High will provide funding
currently estimated to be up to GBP4 million for the expected
remaining R&D work required to gain approval of MED3000
throughout the Region. Futura will be entitled to 50% of profits
from the commercialisation of MED3000 within the Region (the "Joint
Collaboration") including any profits derived from local partner
agreements within the Region.
Atlantis is a leading international asset management company
with a focus in the Greater China Region and South East Asia.
Co-High is a specialist private equity company in the Greater China
region and invests into and collaborates with some of the world's
most promising companies which are believed to be poised to enter a
hypergrowth phase. Healthcare investment and collaboration is
targeted at companies with a clear scientific edge who are working
to solve the major unmet medical needs of the Greater China
region.
Under the terms of the agreement, Futura and Co-High will work
together to develop and commercialise MED3000 as a clinically
proven OTC treatment for ED throughout South East Asia.
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. Current
expectations are that a Chinese clinical trial will be required to
establish safety as well as efficacy in Chinese men. Futura and
Co-High are also working on additional South East Asian regulatory
submissions, where CE mark designation is recognised, and may
result in regulatory approval during 2022 following Futura's first
launch for MED3000.
m8 Pharmaceuticals - Brazil and Mexico
In August 2021 Futura entered into a licensing agreement for
MED3000 with m8 Pharmaceuticals, Inc ("m8"), a specialty
biopharmaceutical company focused on commercialisation in Latin
America, for the rights to exclusively develop and commercialise
MED3000, in Brazil and Mexico.
Under the terms of the agreement Futura and m8 will work
together to gain marketing authorisation and commercialise MED3000
as a clinically proven treatment for ED available without the need
for a doctor's prescription ("OTC") in Brazil and Mexico, the two
biggest countries and healthcare markets in Latin America. The
agreement is for an initial term of 15 years.
m8 will be responsible for all costs related to the regulatory
approval and marketing of the product. Futura will provide
reasonable ongoing technical support for OTC product development
and commercialisation. Futura will receive payments on all sales of
MED3000 from m8, and up to four milestone payments totalling US$8.5
million based on cumulative sales volumes within the initial
term.
Labatec - Gulf Co-operation Council ("GCC") region and Middle
East
In September 2021 Futura entered into a licensing agreement with
Labatec Pharma ("Labatec"), a Swiss-based specialty pharma Company
focused on commercialisation in Europe and the Middle East and
North Africa ("MENA") regions, for the rights to exclusively
commercialise MED3000 in the GCC region as well as Jordan, Lebanon
and Iraq.
Futura is eligible to receive initial upfront payments, as well
as undisclosed milestone payments based on regulatory approval.
Labatec will pay an agreed price to Futura for the manufacture and
supply of MED3000 by Futura's Contract Manufacturing Organisation,
plus royalties on all sales. Labatec is responsible for all local
MED3000 development and regulatory costs as well as all launch and
marketing expenses. The initial licence agreement term is for 8
years with the ability to extend for successive two-year terms by
mutual consent.
MED3000 manufacturing and other commercialisation plans
Manufacturing scale up and capacity to meet projected demand is
progressing well with, in August, the addition of a new, FDA, EMA
and UK approved contract manufacturer as Futura strengthens
resources in the build up towards MED3000 product launches in
2022.
Futura is making steady progress on commercial out-licensing
agreements covering other major regions and countries of the world
with several interested parties. The Company looks forward to
providing further updates in the coming months.
Futura is committed to prioritising commercial deals that will
deliver long-term and sustainable value to the Company allowing a
long-lasting growth franchise to be built around the pipeline of
DermaSys(R) formulated products and in particular MED3000. 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.
TPR100 - 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.
A scientific advisory meeting was held with the Medicines and
Healthcare products Regulatory Agency ("MHRA") confirming the need
of a Phase 3 study to support the improved skin permeation and
potential potency of TPR100 including potential superior efficacy
claims.
Futura is exploring the feasibility of a clinical study that
would satisfy the Phase 3 requirements for both UK and USA
marketing approval. However, this will require a US distribution
partner prior to the commencement of any Phase 3 programme.
CBD100 - Futura's advanced, proprietary DermaSys(R) formulation
for transdermal delivery of cannabidiol
CBD100 is part of a joint venture collaboration with CBDerma
Technology Limited aiming to explore the application of Futura's
advanced proprietary transdermal drug delivery technology,
DermaSys(R) for delivery of cannabidiol.
CBDerma Technology is a company that was established and funded
to specifically exploit the therapeutic potential of cannabis.
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. The market for cannabidiol products
is growing rapidly. A report by Reports and Data forecasts that the
market for cannabidiol products is forecast to grow from US$1
billion in 2018 to US$16 billion by 2026, at a CAGR of 27.7%,
during the forecast period. The market is primarily driven by the
increase in the usage of cannabidiol in medical applications and
cosmetics such as supplements, beverages and skin care.
Futura's extensive DermaSys(R) cannabidiol formulation work has
demonstrated highly efficient penetration of cannabidiol into and
through the skin, superior to an established, marketed, comparator
product. Additionally, cannabidiol is known to be unstable with
many common excipients. CBD100 was specially formulated to minimise
this issue and has shown encouraging early stability work, which is
expected to ensure potency is retained during shelf-life. This work
resulted in robust intellectual property filings covering various
unique aspects of the CBD100 gel formulation.
As the medical and consumer applications of cannabidiol become
more and more accepted and the regulatory environment becomes ever
clearer a gel that has been formulated using strict pharmaceutical
development principles with strong delivery characteristics,
stability and high quality continues to be a very attractive
commercial proposition when compared to current market incumbents
in either cosmetic or more traditional pharmaceutical markets for
cannabidiol such as pain and inflammation. Both options are being
examined and Futura continues to explore commercial opportunities
for the product.
Board update
As the Company moves towards the 2022 launch of MED3000 the
Board considers this is the appropriate time to make several
changes. Jonathan Freeman has been on the Board since the IPO in
2003 and will be stepping down as Senior Independent Non-Executive
Director at the end of 2021. His contribution and support to the
Company has been huge over many years and the Board is unanimous in
thanking him for all his efforts.
In a planned process, management are also working towards
strengthening the Company's Board with the appointment of Non
Executive Directors with additional commercial expertise as Futura
moves into the next phase of MED3000's commercialisation. These
additions are expected to be announced shortly when the recruitment
process completes.
Financial Review
Research and development costs
Research and Development costs for the six months ended 30 June
2021 were GBP1.19 million, compared to GBP0.93 million for the six
months ended 30 June 2020.
Administrative costs
Administrative costs were GBP0.71 million for the six months
ended 30 June 2021 compared to GBP0.47 million for the six months
ended 30 June 2020 and were reflective of the Company's strategy to
maintain a tight central cost base with the slight increase
relating to one-off legal and professional costs totalling
approximately GBP150,000 associated with the funding transactions
and which do not meet the requirements for capitalisation.
Going concern
At the period end the Group held GBP12.76 million of cash. The
Directors believe that it remains appropriate to prepare the
financial statements on a going concern basis.
Cash runway
The company continues to have sufficient cash resources beyond
initial MED3000 launches in 2022 and expected US regulatory
approval. The current runway does not include any revenues from
commercial upfront milestones, royalties or other income generated
from MED3000 sales.
Outlook
The fund raise earlier in the year was pivotal in terms of
strengthening the Company's finances and commercial negotiating
positions and the last nine months have seen Futura achieve
considerable milestones both in the evolution of the Company as it
approaches a sustainable revenue stream and in terms of bringing
MED3000 to patients suffering from erectile dysfunction and lacking
treatments that meet their needs. This includes CE mark approval
for Europe and the UK as an ED treatment for adult men without the
need for a doctor's prescription and several commercial licensing
deals in large markets for ED in regions such as China and South
East Asia, Latin American and the Middle East.
Going forward we are continuing to conduct negotiations for
licensing agreements for MED3000 in additional countries and
regions and are gearing up manufacturing and supply in line with
expected demand ready for first product launches, in several
countries, in 2022. We have added a new FDA, EMA and UK approved
contract manufacturer. Futura aims to create a global 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 world. We look forward to updating the market further on
commercialisation in the coming months.
In a planned process, management are also working towards
expanding the Company's board with appropriate business expertise
and commercial acumen as Futura moves into the next phase of
MED3000's commercialisation. These additions are expected to be
announced shortly when the recruitment process completes.
We are also firmly focused on the US regulatory pathway for
MED3000 with the US confirmatory FM71 clinical trial having
recently started enrolment and running alongside the short,
non-clinical study that is expected to enable US OTC designation.
Everything is on track for planned MED3000 regulatory dossier
submission in the USA by Q3 2022 and a potential marketing
authorisation in Q1 2023. The USA remains the largest market for ED
and OTC status would be a first in the USA, as it is for the
majority of countries within the EU, providing patients with an
accessible, new treatment option, for their ED.
References
1. IQVIA IMS Health
2. EMA, Withdrawal assessment report for Viagra, 2008
CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS
For the six months ended 30 June 2021
Unaudited Unaudited Audited
6 months 6 months year
ended ended ended
30 June 30 June 31 December
2021 2020 2020
Notes GBP GBP GBP
Revenue
Research and development costs (1,192,591) (926,802) (1,927,658)
Administrative costs (709,301) (466,065) (1,000,736)
------------------------------------ ------- ---------------------- ---------------------- ----------------------
Operating loss (1,901,892) (1,392,867) (2,928,394)
Finance income - 938 924
------------------------------------ ------- ---------------------- ---------------------- ----------------------
Loss before tax (1,901,892) (1,391,929) (2,927,470)
Taxation 11 315,000 330,000 519,093
------------------------------------ ------- ---------------------- ---------------------- ----------------------
Total comprehensive loss for
the period attributable to owners
of the parent company (1,586,892) (1,061,929) (2,408,377)
------------------------------------ ------- ---------------------- ---------------------- ----------------------
Basic and diluted loss per share
(pence) 5 (0.62p) (0.44p) (0.99p)
------------------------------------ ------- ---------------------- ---------------------- ----------------------
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
As at 30 June 2021
Unaudited Unaudited Audited
30 June 30 June 31 December
2021 2020 2020
Notes GBP GBP GBP
Assets
Non-current assets
Plant and equipment 32,795 51,350 42,869
Investments 6 - - -
---------------------------------- ----- ------------------- ------------------ ----------------
Total non-current assets 32,795 51,350 42,869
---------------------------------- ----- ------------------- ------------------ ----------------
Current assets
Inventories - 7,780 -
Trade and other receivables 7 83,750 64,871 39,790
Current tax asset 833,805 329,712 518,805
Cash and cash equivalents 8 12,762,201 2,615,085 1,018,601
---------------------------------- ----- ------------------- ------------------ ----------------
Total current assets 13,679,756 3,017,448 1,577,196
---------------------------------- ----- ------------------- ------------------ ----------------
Liabilities
Current liabilities
Trade and other payables 9 (735,303) (950,432) (766,525)
---------------------------------- ----- ------------------- ------------------ ----------------
Total liabilities (735,303) (950,432) (766,525)
---------------------------------- ----- ------------------- ------------------ ----------------
Total net assets 12,977,248 2,118,366 853,540
---------------------------------- ----- ------------------- ------------------ ----------------
Capital and reserves attributable
to
owners of the parent company
Share capital 12 574,142 491,254 491,254
Share premium 66,353,363 52,814,090 52,814,090
Merger reserve 1,152,165 1,152,165 1,152,165
Warrant Reserve 13 165,868 165,868 165,868
Retained losses (55,268,290) (52,505,011) (53,769,837)
---------------------------------- ----- ------------------- ------------------ ----------------
Total equity 12,977,248 2,118,366 853,540
---------------------------------- ----- ------------------- ------------------ ----------------
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
For the six months ended 30 June 2021
Share Share Merger Warrant reserve Other Retained Total
Capital Premium Reserve reserve Losses Equity
Notes GBP GBP GBP GBP GBP GBP GBP
--------------------- ----- -------- ----------- ---------- --------------- --------- ------------ -----------
At 1 January 2020 -
audited 409,321 50,002,990 1,152,165 - - (51,510,824) 53,652
--------------------- ----- -------- ----------- ---------- --------------- --------- ------------ -----------
Total comprehensive
loss for the period - - - - - (1,061,929) (1,061,929)
Share-based payment - - - - - 67,742 67,742
Shares issued during
the period 81,933 2,811,100 - 165,868 - - 3,058,901
--------------------- ----- -------- ----------- ---------- --------------- --------- ------------ -----------
Transactions with
Owners 81,933 2,811,100 - 165,868 - 67,742 3,126,643
--------------------- ----- -------- ----------- ---------- --------------- --------- ------------ -----------
At 30 June 2020 -
unaudited 491,254 52,814,090 1,152,165 165,868 - (52,505,011) 2,118,366
--------------------- -----
Total comprehensive
loss for the period - - - - - (1,346,448) (1,346,448)
Share-based payment - - - - - 81,622 81,622
Shares issued during - - - - - - -
the period
--------------------- ----- -------- ----------- ---------- --------------- --------- ------------ -----------
Transactions with
Owners - - - - - 81,622 81,622
--------------------- ----- -------- ----------- ---------- --------------- --------- ------------ -----------
At 31 December 2020 -
audited 491,254 52,814,090 1,152,165 165,868 - (53,769,837) 853,540
--------------------- ----- -------- ----------- ---------- --------------- --------- ------------ -----------
Total comprehensive
loss for the period - - - - - (1,586,892) (1,586,892)
Share-based payment - - - - - 88,439 88,439
Shares issued during
the period 12 67,888 12,053,273 - - - - 12,121,161
Convertible loan
notes and warrants
issue 13 - - - 118,864 196,909 - 315,773
Shares issued on
conversion of
convertible loan
notes and exercise
of warrants 13 15,000 1,485,000 - (118,864) (196,909) - 1,184,227
Transactions with
Owners 82,888 13,539,273 - - - 88,439 13,710,600
--------------------- ----- -------- ----------- ---------- --------------- --------- ------------ -----------
At 30 June 2021 -
unaudited 574,142 66,353,363 1,152,165 165,868 - (55,268,290) 12,977,248
CONSOLIDATED STATEMENT OF CASH FLOWS
For the six months ended 30 June 2021
Unaudited Unaudited Audited
6 months 6 months year
ended ended ended
30 June 30 June 31 December
2021 2020 2020
GBP GBP GBP
Cash flows from operating activities
Loss before tax (1,901,892) (1,391,929) (2,927,470)
Adjustments for:
Depreciation 11,455 12,353 25,008
Finance income - (938) (924)
Share-based payment charge 88,439 67,742 149,364
---------------------------------------- ---------------------------- ------------------ --------------------
Cash flows used in operating activities
before changes
in working capital (1,801,998) (1,312,772) (2,754,022)
---------------------------------------- ---------------------------- ------------------ --------------------
Decrease in inventories - - 7,780
(Increase) / decrease in trade and
other receivables (43,960) 36,321 61,401
Decrease in trade and other payables (31,222) (3,897,088) (4,080,996)
---------------------------------------- ---------------------------- ------------------ --------------------
Cash used in operations (1,877,180) (5,173,539) (6,765,837)
---------------------------------------- ---------------------------- ------------------ --------------------
Income tax received - 2,222,194 2,222,482
---------------------------------------- ---------------------------- ------------------ --------------------
Net cash used in operating activities (1,877,180) (2,951,345) (4,543,355)
---------------------------------------- ---------------------------- ------------------ --------------------
Cash flows from investing activities
Purchase of plant and equipment (1,381) (3,910) (8,371)
Interest received - 938 924
---------------------------------------- ---------------------------- ------------------ --------------------
Cash used in investing activities (1,381) (2,972) (7,447)
---------------------------------------- ---------------------------- ------------------ --------------------
Cash flows from financing activities
Issue of ordinary shares 12,294,481 3,270,533 3,270,534
Conversion of Convertible loan notes
and warrants 2,000,000 - -
Expenses paid in connection with share
issues (672,320) (211,632) (211,632)
---------------------------------------- ---------------------------- ------------------ --------------------
Cash generated by financing activities 13,622,161 3,058,901 3,058,902
---------------------------------------- ---------------------------- ------------------ --------------------
Increase/(decrease) in cash and cash
equivalents 11,743,600 104,584 (1,491,900)
Cash and cash equivalents at beginning
of period 1,018,601 2,510,501 2,510,501
---------------------------------------- ---------------------------- ------------------ --------------------
Cash and cash equivalents at end of
period 12,762,201 2,615,085 1,018,601
---------------------------------------- ---------------------------- ------------------ --------------------
NOTES TO THE CONSOLIDATED INTERIM FINANCIAL STATEMENTS
For the six months ended 30 June 2021
1. Corporate Information
The interim condensed consolidated financial statements of
Futura Medical plc and its subsidiaries (the "Group") for the six
months ended 30 June, 2021 were authorised for issue in accordance
with a resolution of the Directors on 28 September, 2021. Futura
Medical plc (the "Company") is a public limited company
incorporated and domiciled in the United Kingdom and whose shares
are publicly traded on the AIM Market of the London Stock Exchange.
The registered office is located at Surrey Technology Centre, 40
Occam Road, Guildford, Surrey, GU2 7YG.
The Group is principally engaged in the development of
pharmaceutical and healthcare products.
2. Accounting policies
The accounting policies applied in these interim statements are
consistent with those of the annual financial statements for the
year ended 31 December 2020, as described in those financial
statements except for the new accounting policies described
below.
These condensed interim consolidated financial statements for
the six months ended 30 June 2021 and for the six months ended 30
June 2020 do not constitute statutory accounts within the meaning
of section 434(3) of the Companies Act 2006 and are unaudited.
The Group's financial information for the year ended 31 December
2020 has been extracted from the financial statements of the
statutory accounts ("Annual Report") of Futura Medical plc, which
were prepared in accordance with International accounting standards
in conformity with the requirements of the Companies Act 200 that
were applicable for the year ended 31 December 2020 and does not
constitute the full statutory accounts for that period. The Annual
Report for 2020 has been filed with the Registrar of Companies. The
Independent Auditor's Report on those financial statements was
unqualified and did not contain a statement under Section 498 (2)
or (3) of the Companies Act 2006; though it did include a reference
to a matter to which the auditor drew attention by way of emphasis
without qualifying their report in relation to going concern. It
does not comply with IAS 34 Interim financial reporting, as is
permissible under the rules of AIM.
New convertible loan notes were issued and converted within this
period. The group's accounting policy for convertible loan notes is
detailed below.
Investments in associates
Associates are entities over which the entity has significant
influence but not control or joint control.
Investments in associates are accounted for using the equity
method. Under the equity method, the share of the profits or losses
of the associate is recognised in profit or loss and the share of
the movements in equity is recognised in other comprehensive
income. Investments in associates are carried in the statement of
financial position at cost plus post-acquisition changes in the
consolidated entity's share of net assets of the associate.
Goodwill relating to the associate is included in the carrying
amount of the investment and is neither amortised nor individually
tested for impairment. Dividends received or receivable from
associates reduce the carrying amount of the investment.
When the Group's share of losses in an associate equals or
exceeds its interest in the associate, including any unsecured
long-term receivables, the Group does not recognise further losses,
unless it has incurred obligations or made payments on behalf of
the associate.
The Group discontinues the use of the equity method upon the
loss of significant influence over the associate and recognises any
retained investment at its fair value. Any difference between the
associate's carrying amount, fair value of the retained investment
and proceeds from disposal is recognised in profit or loss.
2. Accounting policies (continued)
Convertible loan notes
The component of the convertible notes issued by the Group which
exhibits the characteristics of a financial liability is recognised
as a liability in the statement of financial position, net of
transaction costs.
On the issue of the convertible notes the fair value of the
liability component is determined using a market rate for an
equivalent non-convertible bond and this amount is recorded as a
non-current liability measured at amortised cost until extinguished
on conversion or redemption. The increase in the liability due to
the passage of time is recognised as a finance cost. The remainder
of the proceeds are allocated to the conversion option that is
recognised and included in shareholders equity as an other reserve,
net of transaction costs. The carrying amount of the conversion
option is not remeasured in the subsequent years. The corresponding
interest on convertible notes is expensed to profit or loss.
Other reserve
On initial recognition of the convertible loan notes the
consideration received for issuing the notes was split between the
equity and liability components in accordance with IAS 32
'Financial Instruments: Presentation'. This other reserve
represents the equity component of the convertible loan notes.
3. Critical accounting judgements, assumptions and estimates
The preparation of the interim condensed consolidated financial
statements in conformity with IFRS requires management to make
certain estimates, assumptions and judgements that affect the
application of accounting policies and the reported amounts of
assets and liabilities and the reported amounts of income and
expenses in the period.
Critical accounting estimates, assumptions and judgements are
continually evaluated by the Directors based on available
information and experience. As the use of estimates is inherent in
financial reporting actual results could differ from these
estimates.
3.1 Going concern
The Group has reported a loss after tax for the six months ended
30 June 2021 of GBP1.59 million (six months ended 30 June 2020:
GBP1.06 million, year ended 31 December 2020: GBP2.41 million). The
Group holds cash balances of GBP12.76 million at 30 June 2021 (30
June 2020: GBP2.62 million, 31 December 2020: GBP1.02 million).
In the six months to 30 June 2021, the Group concluded equity
funding arrangements totalling GBP14.29 million. Directors have
considered the applicability of the going concern basis in the
preparation of the financial statements. This includes the review
of internal budget, financial results and cashflow forecasts for
the 12 months' period following the date of signing the financial
statements. These forecasts show that the Group has sufficient
funds to allow the business to continue in operations for at least
12 months from the date of approval of these financial statements.
The Directors also have a reasonable expectation that the Group
will be able to generate other funding through entering into
strategic collaborations for the commercialisation of MED3000
product following regulatory approval across UK and Europe in April
2021 and approval in the USA expected to follow.
Based on the above factors the Directors believe that it remains
appropriate to prepare the financial statements on a going concern
basis. The financial statements do not include any adjustments that
would result from the basis of preparation being inappropriate.
3.2 Estimates and assumptions
Share-based payments
The Group operates an equity-settled share-based compensation
plan for employee (and consultant) services to be received and the
corresponding increases in equity are measured by reference to the
fair value of the equity instruments as at the date of grant. The
fair value determination is based on the principles of the
Black-Scholes Model, the inputs of which uses an input of
volatility based on historical data. Historical volatility may not
be indicative of future volatility, yet the Directors judge this to
be the most appropriate method of calculation. Given the share
option expense of GBP88,439 for the six months ended June 2021 (six
months ended 30 June 2020: GBP67,742, year ended 31 December 2020:
GBP149,364), the volatility method used is not expected to have a
material impact on these financial statements.
Valuation of convertible loan notes
The fair value of the liability component of the convertible
loan notes was calculated using the prevailing market interest rate
for a similar non-convertible instrument being 10%.
Valuation of warrants
Warrant instruments were measured at fair value using the
Black-Scholes model. The following inputs were used for the
model:
Share price 16.5p
Warrant exercise
price 22.0p
Expected life of 1 year
warrant
Volatility 105.08%
Dividend yield 0%
Risk free interest
rate 0.14%
Fair value 5.23p
3.3 Judgements
Conversion of convertible loan notes and warrant instruments
The Group issued a new convertible loan note and warrants on 4
March 2021. In accordance with the Group's accounting policy as
detailed in note 2, the liability and equity components of the
instruments were calculated at fair value as detailed in note 13.
These instruments were subsequently converted to equity before the
period end of 30 June 2021. Management has concluded that the
GBP1,184,227 liability converted to equity at its liquidated sum of
GBP1.5m resulting in an increase in retained losses of GBP315,773
with a corresponding increase in share premium. On conversion, the
warrant reserve and other reserve amounting to GBP315,773 created
on the issue of the two instruments also reverses therefore
decreasing retaining losses by the same amount.
Deferred tax recognition
The determination of probable future profits, against which the
Group's deferred tax profits can be offset, requires judgement. To
date no tax assets have been recognised.
R&D Tax Credits
The current tax receivable represents an estimate of the
anticipated R&D tax credit in respect of claims not yet
submitted for the 2021 financial year. The final receivable is
subject to the correct application of complex R&D rules and
HMRC approval. Historically, claims have been successful, and the
Group expects the current year to be successful too.
3.3 Judgements (continued)
Initial accounting for investments in associated
undertakings
During the year the Group entered into a collaboration agreement
with Pride Century Ventures Limited ("Pride"). A special purpose
vehicle ("SPV") was set up for the purpose of conducting the
activities under the collaboration agreement. On the basis that the
Group was entitled to voting rights on a steering committee which
directs principally all of the relevant activities of the SPV
management have concluded the Group has significant influence over
the SPV. In line with the Group's accounting policies and the
requirements of IAS 28 Investments in Associates and Joint Ventures
the SPV was initially recognised at cost.
A financing agreement was entered into at the same time as the
collaboration agreement with a party related to the SPV by common
control. Given the fact the two arrangements were entered into at
the same time, and the relationships between the parties involved,
management have assessed the two contracts to determine whether
they are linked.
Management have concluded that the agreements are not linked,
with the principal reasoning being:
-- there are no terms in the collaboration agreement which
reference the finance agreement or vice-versa;
-- the two agreements were negotiated separately; and
-- management believe that had one of the agreements fallen
through, the other could still have proceeded on the same terms
provided adequate funding to support Futura's obligations under the
collaboration agreement could be sourced from elsewhere.
There was no initial consideration payable in respect of
entering into the collaboration agreement, and given the
conclusions above, management have assessed that the initial cost
of investment is GBPnil. This meets with management's expectations
on the basis that the Chinese market accessed as part of the
collaboration agreement would be difficult to access without
incurring significant additional costs, and whilst the agreement
allows for a future revenue stream, no approvals had been granted
over the product being licenced for research under this agreement
at the time it was entered into. As such, the value of any future
revenue streams was uncertain at the time the contract was
made.
Had management concluded that the two agreements were linked it
would have been necessary to determine the fair value of each item
within the agreement, an initial cost of investment would have been
recognised with a corresponding adjustment to the initial
recognition of the finance agreement and impacts to the subsequent
accounting of the finance agreement through the interest
charge.
4. Segment reporting
The Group is organised and operates as one segment.
5. Loss per share (pence)
The calculation of the loss per share is based on a loss of
GBP1,586,892 (six months ended 30 June 2020: loss of GBP1,061,929;
year ended 31 December 2020: loss of GBP2,408,377) and on a
weighted average number of shares in issue of 254,590,594 (six
months ended 30 June 2020: 241,794,738; year ended 31 December
2020: 243,721,303). The loss attributable to equity holders of the
Company for the purpose of calculating the fully diluted loss per
share is identical to that used for calculating the basic loss per
share. The exercise of share options, or the issue of shares under
the long-term incentive scheme, would have the effect of reducing
the loss per share and is therefore anti-dilutive under the terms
of IAS 33 'Earnings per Share'.
6. Investments
During the year the Group entered into a collaboration agreement
with Pride Century Ventures Limited ("Pride"). A special purpose
vehicle ("SPV") was set up for the purpose of conducting the
activities under the collaboration agreement. On the basis that the
Group was entitled to voting rights on a steering committee which
directs principally all of the relevant activities of the SPV
management have concluded the Group has significant influence over
the SPV. In line with the Group's accounting policies and the
requirements of IAS 28 Investments in Associates and Joint Ventures
the SPV was initially recognised at cost. Management have concluded
that the initial cost of investment was GBPnil (see note 3.3).
7. Trade and other receivables
Unaudited Unaudited Audited
30 June 30 June 31 December
2021 2020 2020
GBP GBP GBP
Amounts receivable within one year:
Trade receivables 21,333 5,627 5,627
Other receivables 10,440 10,440 10,440
------------------------------------ ----------------- ------------------- ----------------
Financial assets 31,773 16,067 16,067
Prepayments and accrued income 51,977 48,804 23,723
------------------------------------ ----------------- ------------------- ----------------
83,750 64,871 39,790
------------------------------------ ----------------- ------------------- ----------------
Trade and other receivables do not contain any impaired assets.
The Group does not hold any collateral as security and the maximum
exposure to credit risk at the Consolidated Statement of Financial
Position date is the fair value of each class of receivable.
8. Cash and cash equivalents
Unaudited Unaudited Audited
30 June 30 June 31 December
2021 2020 2020
GBP GBP GBP
Cash at bank and in hand 12,762,201 2,241,367 644,729
Sterling fixed rate short-term
deposits - 373,718 373,872
------------------------------- ----------------- ----------------- -----------------------
12,762,201 2,615,085 1,018,601
------------------------------- ----------------- ----------------- -----------------------
9. Trade and Other Payables
Unaudited Unaudited Audited
30 June 31 December 31 December
2021 2020 2020
GBP GBP GBP
Trade payables 483,502 381,838 182,900
Social security and other taxes 43,926 56,142 64,092
Accrued expenses 207,875 512,452 519,533
-------------------------------- ----------- -------------- --------------
735,303 950,432 766,525
-------------------------------- ----------- -------------- --------------
10. Related party transactions
Related parties, as defined by IAS 24 'Related Party
Disclosures', are the wholly owned subsidiary companies: Futura
Medical Developments Limited and Futura Consumer Healthcare Limited
and the Board. Transactions between the Company and the wholly
owned subsidiary companies have been eliminated on consolidation
and are not disclosed.
11. Taxation
The Group's tax credit in the six months ended 30 June 2021 was
GBP0.32 million (six months ended 30 June 2020: GBP0.33m, year
ended 31 December 2020: GBP0.52 million). The current period tax
credit relates to anticipated R&D tax credits in respect of
claims not yet submitted for the 2021 financial year.
12. Share Capital
30 June 30 June 31 December 30 June 30 June 31 December
Authorised 2021 2020 2020 2021 2020 2020
Number Number Number GBP GBP GBP
Ordinary shares
of
0.2 pence each 500,000,000 500,000,000 500,000,000 1,000,000 1,000,000 1,000,000
------------------ ------------- ------------- ------------- ------------------ ------------------ -------------
Allotted, called 31 December 31 December
up 30 June 30 June 2020 30 June 30 June 2020
and fully paid 2021 2020 2021 2020
Number Number Number GBP GBP GBP
Ordinary shares
of
0.2 pence each 287,070,971 245,626,926 245,626,926 574,142 491,254 491,254
------------------ ------------- ------------- ------------- ------------------ ------------------ -------------
The number of issued ordinary shares as at 1 January 2021 was
245,626,926. During the period of six months ended 30 June 2021,
the Company issued 41,444,045 ordinary shares of 0.2 pence with
each ordinary share carrying the right to one vote as follows:
GBP Number
March 2021 Exercise of Share Options 30,600 425,000
April 2021 Non-Executive Director Share Award 21,581 176,318
April 2021 Exercise of Share Options 27,000 360,000
April 2021 Exercise of Share Options 75,000 250,000
April 2021 Exercise of Share Options 140,300 460,000
April 2021 Exercise of Warrants 500,000 2,272,727
Conversion of Convertible Loan
April 2021 Notes 1,500,000 7,500,000
June 2021 Placing and Retail Offer 12,000,000 30,000,000
-------------- ------------------------------------- --------------- ------------
14,294,481 41,444,045
---------------------------------------------------- --------------- ------------
13. Convertible Loan Notes and Warrant Instrument
On 4 March 2021, the Company created 100 GBP15,000 unsecured
convertible loan notes ("Notes"). The Notes attract an interest
rate of 2% per annum payable annually following an initial
interest-free period of 180 days. The noteholder was entitled, at
any time within 36 months of the date of the instrument ("Maturity
Date"), to serve a conversion notice on the Company to convert all
or some only of the outstanding Notes into fully paid ordinary
shares at a conversion price of GBP0.20 per share. To the extent
the Notes would not be converted at the Maturity Date, the
outstanding principal amount of the Notes, together with any
accrued interest, would have been redeemable.
In addition, 2,272,727 warrants ("Warrants") were issued to the
noteholder to subscribe to ordinary shares exercisable within 48
months of issue at a conversion price of GBP0.22 taking the total
number of warrants in issue to 13,210,227. The warrants were valued
using the Black-Scholes model.
The initial value of the debt component of the Notes was
calculated as GBP1,184,227. The cash flows attached to the Notes up
to the Maturity Date were calculated and discounted at an
appropriate venture debt rate of 10%. The fair value of the
Warrants was calculated at GBP118,864 and the residual value of the
equity component of the Notes was calculated as GBP196,909.
On 1 April 2021, the noteholder exercised the Warrants in full
at an exercise price of GBP0.22 and was issued with 2,272,727
ordinary shares. On 15 April 2021, the noteholder converted the
loan notes in full and was issued with 7,500,000 ordinary
shares.
14. Subsequent events
There were no material post-period events.
Company number
04206001
Directors
John Clarke Non-Executive Chairman
James Barder Chief Executive Officer
Angela Hildreth Finance Director and Chief Operating Officer
Jonathan Freeman Non-Executive Director
Ken James Head of R&D and Executive Director
Audit committee
Jonathan Freeman
John Clarke
Secretary and registered office
Angela Hildreth
Futura Medical plc
Surrey Technology Centre
40 Occam Road
Guildford
Surrey
GU2 7YG
Nominated adviser and broker
Liberum
25 Ropemaker Street
London
EC2Y 9LY
Principal bankers
HSBC Bank
12A North Street
Guildford
GU1 4AF
Remuneration committee
Jonathan Freeman
John Clarke
Auditors
Grant Thornton UK LLP
1020 Eskdale Road
Winnersh
Wokingham
Berkshire
RG41 5TS
Patent attorneys
Withers & Rogers LLP
2 London Bridge
London
SE1 9RA
Nominations committee
John Clarke
Jonathan Freeman
Registrars
Link Group
Unit 10
29 Central Square
Leeds
LS1 4DL
Public relations advisers
Optimum Strategic Communications
8 Devonshire Square
Spitalfields
London
ECM 4PL
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