REG - Genedrive PLC - Final Results
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RNS Number : 3572K Genedrive PLC 05 December 2025
genedrive plc
("genedrive" or "the Company" or "the Group")
Audited Final Results
genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company,
announces its audited Final Results for the year ended 30 June 2025.
Financial Highlights
§ Revenue and other income increased 100% to £1m (2024: £0.5m).
§ Loss after tax reduced to £5.2m (2024: £7.1m).
Cost base shift from pre-commercial to commercial focus.
§ Diagnostics: R&D, Scientific, Engineering (Electronic,
Hardware and Software) expenditure of £4.2m (2024: £4.2m).
Continued investment in supporting commercial stage novel and disruptive
products.
§ Successful equity fundraise of £1.23m (gross) announced in March
2025.
§ Cash at bank of £1.2m and debt free at 30 June 2025 (2024: £5.2m).
Operational Highlights (including post period end)
Genedrive(®) CYP2C19
§ Several national and international guidelines supporting CYP2C19
pharmacogenetic testing to tailor antiplatelet therapies in stroke and
cardiovascular disease, including CPIC, NICE, US FDA and the American Heart
Association, with NICE recommending the Genedrive® CYP2C19 ID Kit as the
preferred rapid testing platform for CYP2C19 genotyping in stroke and
transient ischaemic attack.
§ Completion of DEVOTE study, with Clinical performance subsequently
published in Journal of Molecular Diagnostics publication, highlighting
superior performance of the Genedrive® CYP2C19 ID Kit compared to laboratory
platform with respect to target coverage, speed, accuracy and failed tests.
§ Following UKCA marking, Achieved CE-certification (May 2025) under
the European In Vitro Diagnostics Regulation (IVDR), permitting registrations
and commercial progress in the EU and other countries accepting
CE-certification.
§ Accepted onto the NHS Dynamic Procurement System (DPS); an
innovative procurement process that has been developed to streamline and
accelerate access to cutting-edge medical technologies permitting direct
procurement by regional NHS trusts.
§ First commercial sales to Salford Royal Hospital, England's
largest Hyperacute Stroke Centre (HASU); currently in routine clinical use.
§ North West Anglia Foundation NHS Trusts' Peterborough City Hospital
implantation for routine clinical use.
§ 12-month expansion of use study to include Acute Coronary Syndrome
(ACS); led by the Manchester University NHS Foundation Trust (MFT).
§ Scotland's Accelerated Innovation Adoption pathway (ANIA) referral
to the Scottish Health Technology group (SHTG) with positive value assessment
leading to Scottish Government announcement of investment to support national
pharmacogenetic testing of CYP2C19 in Stroke patients, including Genedrive's
CYP2C19-ID test for rapid genetic testing in TIA patients.
§ Included in Scotland pilot of CYP2C19 genotyping in rural areas
for assessment against laboratory testing pathways in Transient Ischaemic
Attack (TIA) clinics.
§ Inclusion in NHS England programme aimed at understanding how best
to deliver CYP2C19 based genotyping at scale throughout the NHS, with results
underpinning recently published NHS Implementation Guide for CYP2C19 Genotype
Testing presented at the UK Stroke Forum, clearly highlighting the positive
case for implementation of our rapid CYP2C19 testing platform.
§ Market access routes and reimbursement strategies defined in key
initial international target countries, including Europe and the Middle East
region, with well-positioned and aligned in-country distributors.
§ 510(k) route identified for regulatory submission for US market
entry, with initial pre-submission engagement with Food and Drug
Administration (FDA) held and feedback positive and with regulatory approach
confirmed as appropriate. Several rounds of formal engagement with the FDA
pre-submission team, with (pending certainty of cash runway) submission under
the 510(k) pathway planned for late-Q4 FY26 with an expected 3-4 month
subsequent review period.
§ Translation of CYP2C19 IP to laboratory platform CYP2C19 genotyping
in addition to point of care.
§ Inclusion in several key European clinical studies utilising rapid
interventional CYP2C19 genotyping.
Genedrive(®) MT-RNR1
§ Following highest "conditional" recommendation by NICE's new Early
Value Assessment (EVA) pathway for use in the UK NHS while further evidence is
generated, awarded NIHR and OLS Funding Package of c.£500k to address Real
World Evidence generation requirements to transition the recommendation from
"conditional" to "full" (PALOH-UK).
§ Launch of PALOH UK across the four UK nations, and in smaller NICU
Tier settings. In routine use at 14 hospitals, equating to c.10% of the UK
market.
§ Accepted onto the NHS Dynamic Procurement System (DPS); an
innovative procurement process that has been developed to streamline and
accelerate access to cutting-edge medical technologies permitting direct
procurement by regional NHS trusts.
§ Scotland's Accelerated Innovation Adoption pathway (ANIA) referral
to the Scottish Health Technology group (SHTG) with positive value assessment
leading to the Scottish Government committing £0.8m investment to support
national phased implementation program of pharmacogenetic testing of MT-RNR1
in newborn babies throughout NHS Scotland. Live at the Royal Hospital for
Children (RHC) in Glasgow, with the Royal Alexandra Hospital and Princess
Royal Maternity Hospital soon to follow. Phased implementation to all
territorial health boards with neonatal units over the next 18 months.
§ 20 babies identified as positive for the MT-RNR1 DNA variant since
introduction of the test into Neonatal Intensive Care Units (NICU) in the UK
and avoiding lifelong hearing loss resulting from aminoglycoside exposure.
§ Outside of the UK PALOH-UK programme, implementation into Dublin's
Rotunda Hospital.
§ Operational and commercial progress in key international
geographies, including several in Europe and Middle East region, with
well-positioned and aligned in-country distributors.
§ Memorandum of Understanding (MOU) with the Kingdom of Saudi Arabia
(KSA) Ministry of Health (MOH). The MOU scope is to pilot the Genedrive®
MT-RNR1 ID Kit for potential national implementation under a national
initiative "Generations Hear".
§ Following Breakthrough Device Designation (BDD) from the U.S. FDA
several rounds of formal engagement with the FDA BDD team clarifying evidence
generation requirements, with a planned submission under the de novo route
expected towards the end of calendar year 2026 (pending certainty of cash
runway).
Genedrive
§ Awarded an additional £0.2m in non-dilutive grant funding under
Innovate UK's Development and Validation of Technology for Time Critical
Genomic Testing (DEVOTE) Programme
§ Expansion of operational capabilities; onshoring and increased
production pipeline of instrumentation, with internalisation of MT-RNR1 and
CYP2C19 assay manufacturing to be dual-source supply and complement external
vendors scaled-up production capabilities.
§ Growing base of post-implementation phase "routine clinical user"
sites which in turn lead to recurring revenue source for both tests.
§ Developed strategic sales and marketing partnerships, expanded
in-country distributors and facilitated in-country market access.
§ Product Development: focus on on-market product support of CYP2C19
and MT-RNR1, with routine product improvements to further facilitate ease of
implementation and usability.
Financial position
§ Cash position at 30 November 2025 of £0.32m relative to an average
monthly cash burn of c. £0.35m.
§ Heads of terms agreed for a £1m loan from the Company's largest
shareholder and discussions are progressing to finalise this.
Gino Miele, CEO of genedrive plc, said: "We are pleased to announce our FY25
final results, which show strong commercial and operational progress and
reflect the hard work, dedication and commitment of the genedrive team. I
would like to extend my thanks to our people, collaborators, shareholders and
distributors for their support and I look forward to our Group continuing to
grow and lead in emergency care pharmacogenetic testing."
For further details please contact:
genedrive plc +44 (0)161 989 0245
Gino Miele CEO / Russ Shaw: CFO
Peel Hunt LLP (Nominated Adviser and Joint Broker) +44 (0)20 7418 8900
James Steel
Walbrook PR Ltd (Media & Investor Relations) +44 (0)20 7933 8780 or genedrive@walbrookpr.com
(mailto:genedrive@walbrookpr.com)
Anna Dunphy +44 (0)7876 741 001
About genedrive plc (http://www.genedrive.com (http://www.genedrive.com) )
genedrive plc is a pharmacogenetic testing company developing and
commercialising a low cost, rapid, versatile and simple to use point of need
pharmacogenetic platform for the diagnosis of genetic variants. This helps
clinicians to quickly access key genetic information that will aid them make
the right choices over the right medicine or dosage to use for an effective
treatment, particularly important in time-critical emergency care healthcare
paradigms. Based in the UK, the Company is at the forefront of Point of Care
pharmacogenetic testing in emergency healthcare. Pharmacogenetics informs on
how your individual genetics impact a medicines ability to work for you.
Therefore, by using pharmacogenetics, medicine choices can be personalised,
made safer and more effective. The Company has launched its two flagship
products, the Genedrive® MT-RNR1 ID Kit and the Genedrive® CYP2C19 ID Kit,
both developed and validated in collaboration with NHS partners and deployed
on its point of care thermocycler platform. Both tests are single-use
disposable cartridges which are ambient temperature stable, circumventing the
requirement for cold chain logistics. The Directors believe the Genedrive®
MT-RNR1 ID Kit is a worlds-first and allows clinicians to make a decision on
antibiotic use in neonatal intensive care units within 26 minutes, ensuring
vital care is delivered, avoiding adverse effects potentially otherwise
encountered and with no negative impact on the patient care pathway. Its
CYP2C19 ID Kit which has no comparably positioned competitor currently allows
clinicians to make a decision on the use of Clopidogrel in stroke patients in
70 minutes, ensuring that patients who are unlikely to benefit from or suffer
adverse effects from Clopidogrel receive an alternative antiplatelet
therapeutic in a timely manner, ultimately improving outcomes. Both tests have
undergone review by the National Institute for Health and Care Clinical
Excellence ("NICE") and have been recommended for use in the UK NHS.
The Company has a clear commercial strategy focused on accelerating growth
through maximising in-market sales, geographic and portfolio expansion and
strategic M&A, and operates out of its facilities in Manchester.
Chairman's Statement
From Innovation to Impact: genedrive's next chapter
Over the course of my career, I have been privileged to chair and lead a
number of UK and European life sciences companies, from Axis Shield, where I
was CEO until its £235 million acquisition by Alere, to Horizon Discovery,
which I chaired through its IPO and subsequent £296 million sale to
PerkinElmer. I am also a non-executive director of Novacyt, chair of LifeArc,
RevoNA Bio, and, for the past decade, here at genedrive plc.
What unites these organisations is not only their commitment to advancing
science but their ability to turn innovation into impact. Each one has
developed technologies that have either improved patient outcomes directly or
enabled others to deliver life sciences innovation at scale. And yet, in
reflecting on these experiences, one challenge has become increasingly clear:
while the UK consistently produces world-class science, the access to capital
needed to scale businesses is often limited.
Many AIM-listed small-cap companies operate in a cycle where breakthrough
technologies are often proven, but the ability to fully commercialise them can
be constrained by limited financial support including from our domestic end
market. This has too often left promising businesses exposed and ultimately
pushed towards an exit early on in the growth trajectory. While those exits
can generate value and jobs, one cannot help but wonder what could have been
achieved if companies had been properly capitalised to grow to their full
potential here.
Based in Manchester, genedrive is a homegrown UK company at the global
forefront of pharmacogenetic testing. We specialise in rapid, point-of-care
genetic tests designed for emergency healthcare settings to guide safe and
effective drug prescription for patients. These technologies have been
developed with the NHS, for the NHS, to address real-world clinical needs.
Today, genedrive has two CE-IVD approved and NICE-recommended pharmacogenetic
tests already in use. These tests are not only improving patient safety and
outcomes but also help reduce NHS waiting lists, supporting equitable access
to care, and delivering meaningful cost savings to the system. Importantly,
this is no longer just about promise, it is about delivery.
We are now in active commercial rollout. We have doubled revenues from 2024
levels, reaching £1 million in the year to 30 June 2025. Discussions with NHS
Trusts and Integrated Care Boards across England are progressing, and
necessary pilots and studies are going well across indications. We have been
selected for national roll out in Scotland, and there is growing interest
internationally, highlighting significant export potential as the Company
grows. For the first time, genedrive is building commercial momentum,
positioning itself not only as a leader in the UK, but also a first mover on
the global stage.
This matters for three reasons.
1) It demonstrates that the UK can produce and commercialise innovative
technologies that directly support the NHS.
2) It proves that world-class science is not just a London story. It is
being delivered from the Northern Powerhouse, generating jobs and growth in
Manchester and beyond.
3) It highlights why the UK's investment ecosystem must do better at
supporting companies at this crucial inflection point.
genedrive has been through the long, necessary journey of technology
development. We are now positioned at the point of commercial success. If
this company were coming to market today, it would be a strong AIM IPO
candidate, backed by proven technology, regulatory approval, NICE
recommendation, adopted by the NHS, and fast growing revenues.
This is the moment for investors and government to take note. Supporting
companies like genedrive is about more than one balance sheet. It is about
backing the UK's ability to capture economic value, create high-skilled jobs,
and ensure that homegrown innovation benefits UK patients first.
genedrive is ready, with the right support, it can become a sustainable and
globally competitive business. The UK has an opportunity here; one we cannot
afford to miss.
Whilst the Group had conditionally raised £3.6m earlier in the year the vast
majority of these proceeds were not received as the requisite shareholder
approval was not obtained at a general meeting held in October. At the time,
that equity financing was the only viable option open to the Company however
with gross proceeds of £0.8m raised by way of the Firm Placing (which did not
need shareholder approval) the Group's cash runway was extended from the
middle of October through to the end of 2025. Subsequently the Group has
agreed heads of terms for a £1m loan from its largest shareholder and
discussions are progressing to finalise this. Recognising the importance of
preserving cash at the current time all Board members have agreed to a 20% cut
to remuneration until such time that that the Company raises funding which
materially extends the cash runway through 2026.
In closing, I would like to express my sincere appreciation to you, our valued
shareholders, for your continued trust and financial support providing the
investment required to bring life-changing health technologies through
development, validation, regulatory pathways and to grow and scale. I would
also like to thank our dedicated staff and collaboration partners for their
unwavering commitment during this demanding period. Together, we remain firmly
focused on advancing our technology towards commercialisation and building
long-term value for patients, shareholders and all stakeholders.
Dr Ian Gilham
Chairman
Chief Executive's Review
Accelerating the implementation of UK Life Sciences innovation
Overview
I'm pleased to report on our continued commercial growth trajectory, with the
doubling of revenue in the year ending 30 June 2025, further demonstrating the
success of our strategic pivot from infectious disease molecular diagnostics
to PGx in emergency healthcare, and laying the foundations for progressive
market expansion.
As a Group, we have never been under any illusions that implementing novel,
disruptive and high impact technologies into global healthcare systems would
be anything other than a significant challenge. Developing these
innovative solutions that address significant clinical unmet needs require
collaborative integration with diverse sets of stakeholders through the
product development and clinical implementation pathway. Moreover,
implementation at scale requires redistribution of care pathway funding, with
financial savings currently realised downstream of the place of interventional
(and budgetary) need.
The NHS faces the challenge of reducing waiting lists, cutting costs, and
improving patient outcomes, with prevention central to the Government's NHS-10
Year Plan ambitions.
At genedrive, we are aligned well to these aspirations. We developed our
tests with the NHS for the NHS, to ensure alignment to their understandably
impeccably high standards in performance, patient safety, regulatory, and
procurement procedures.
We operate as at the forefront of an emerging clinical market, with guidance,
recommendations and care pathways being defined in parallel. Changing clinical
practice takes time, internationally and in our domestic market. We know that
our tests are needed by the patients, wanted by clinicians and the assessments
from NICE and SHTG vindicate the clinical, financial and productivity benefits
that our interventions enable.
The final and perhaps most crucial challenge is unlocking the funding to pay
for the tests. The financial benefit of interventional tests such as ours
are realised downstream in the care pathway whereas budgetary requirements for
intervention are upstream. With this in mind, we welcome the ambition of the
newly published NHS 10-Year Plan, which aims to raise standards, reduce
waiting lists, and keep people healthier for longer, with a shift from
"treatment" to "prevention" at the core. Defining implementation plans for
delivering on the NHS plan is crucial. Alongside this, the Life Sciences
Sector Plan provides a roadmap for harnessing the sector's power to innovate,
scale and make it central to the Government's industrial strategy and drive
growth across the entire nation.
Less widely reported, but equally significant, is the Medicines and Healthcare
products Regulatory Agency Statement of Policy Intent: Early Access to
Innovative Medical Devices, setting out a supportive, risk-proportionate
regulatory environment to ensure safe, timely access to technologies that
address unmet NHS needs. Practically, this means faster regulatory approvals,
streamlined market access, and making Great Britain an increasingly attractive
base for innovators to start, grow, scale, and invest. Initiatives such as
NICE approved MedTech funding routes and the NHS Innovator Passport are
welcome steps. But for real impact, funding decisions MUST be swift and
strategic. If prevention is truly at the heart of the Government's mission,
long-term system savings and central funding pools must be prioritised over
leaving isolated departments constrained and unable to adopt innovation
quickly.
We are energised by the collective impact these measures could have. At
genedrive, our products are CE-IVD approved, NICE-recommended, and offer
significantly better patient outcomes whilst truly enabling financial and
productivity gains to pressured healthcare systems. Aligning fully with NHS
reform ambitions and specifically, "prevention" rather than treatment. This
applies equally in our international markets, where the clinical issues we are
addressing are of global relevance.
We look forward to working with the NHS, regulators, and industry to create a
simpler, faster, and more patient-impactful environment. With the right
structures, timely decision making and sensible access to reallocation of
unnecessarily wasteful financial resources, transforming patient care while
driving economic growth is within reach.
Performance
Total income from FY25 increased to £1m (FY24: £0.5m, FY23: £0.06m) and was
driven by increased sales momentum in H2 FY25 which saw income of £0.65m (H1
FY25 £0.35m). The Company's operating loss remained in line with the prior
year however with a strategic shift towards focussed commercial activities.
Our MT-RNR1 ID Kit test is being used in 14 neonatal intensive care units
(NICU) across England, Wales and Northern Ireland and is being rolled out
nationally in Scotland.
Our domestic revenue ramp is intrinsically linked to an increase in better
patient outcomes and the realisation of cost savings to the NHS and ultimately
the UK taxpayer. As the UK Government commits to a significant shift in
focus by prioritising prevention over treatment, our product portfolio leaves
us well positioned to build on this momentum. Of course, it is important
that we focus commercial efforts outside of the challenging market presented
by the UK NHS, and I am pleased that our year-on-year revenue growth evidences
product-market fit, both in our domestic market and international territories
where we are seeing initial operational and commercial traction in European
countries adopting, such as Italy, Netherlands, and Middle East countries
including UAE, Bahrain, Kuwait, Saudi Arabia and Qatar, and I look forward to
further growth in these and other regions as we progress.
Building on FY25 total income of c.£1m, the Group has visibility currently
for around £0.9m of total income already in FY26, which is based around:
§ NICE Early Value Assessment (EVA) evidence generation completion
and submission, which is expected to be a catalyst for wider UK
implementation.
§ Scotland's phased national implementation of the Genedrive®
MT-RNR1 ID Kit and the CYP2C19 point of care pilot (an assessment against
laboratory testing pathways) both commenced in October 2025.
§ The Manchester University NHS Foundation Trust commencement of the
12-month Acute Coronary Syndrome and CYP2C19 rapid genotyping programme.
FY26 revenues are also expected to increase further going forwards as our
international commercial activities continue to gain pace following recent
preliminary sales of both products in our key international target markets of
Europe and the Middle East.
The U.S. remains a significant market opportunity as we progress with FDA
under the Breakthrough Device for the Genedrive® MT-RNR1 ID Kit according to
plan and we anticipate submission in late-2026. The FDA 510(k) submission
for Genedrive® CYP2C19 ID Kit was originally planned for early 2026. However,
recent financial constraints affecting the required in-country studies are
expected to shift the submission timeline toward Q4 FY26, subject to securing
the necessary funding.
Outlook
The healthcare political and strategic landscape is changing. Through the 10
Year Health Plan for England the Government is committed to unlocking the
extraordinary potential of the HealthTech and MedTech sectors. Unlike for
medicines, there is currently no national pathway to prioritise and nationally
fund the highest impact NICE recommended MedTech.
As a Group with two CE-IVD certified, NICE recommended diagnostic products, we
welcome the expansion of NICE's technology appraisal pathway, which aims to
include mandated funding by the NHS, to cover medical devices, diagnostics and
digital products. These changes are reported to be in place by April 2026.
Adoption of innovation will be a criterion for how providers and commissioners
will be judged under a new regime and the introduction of a new 'innovator
passport' will allow technology that has been robustly assessed by one NHS
organisation to be easily rolled out to others. The planned healthcare
reforms at national level are significant for companies such as ours.
Our best-in-class CE-IVD certified, NICE-recommended rapid near patient
genetic tests represent novel innovative solutions to clinical issues of
global relevance and enable significantly better patient outcomes in
neonatology, neurology and cardiology, as well as substantial productivity
gains and financial savings for pressured healthcare systems (freeing of
resources).
Our rapid CYP2C19 test enables reduction of risk of secondary stroke
recurrence by guiding antiplatelet treatment and potentially preventing
c.3,000 recurrent strokes each year in the UK, and our MT-RNR1 test enables
reduction of risk of lifelong profound deafness in neonates exposed to
aminoglycoside antibiotics by providing clinicians with genotype status.
These novel disruptive interventions address clinical issues of global
relevance, and whilst capitalising on our domestic market is a priority, we
are focused on increasing operational and commercial traction in international
territories, particularly in the Middle East region.
Our technology is already delivering improved patient outcomes in real-world
emergency healthcare environments and scaling nationally offers hundreds of
millions of financial value across the NHS and aligns perfectly to NHS reform
ambitions, as well as with healthcare goals internationally.
The Group requires additional funding for growth and to bridge the path to
profitability. Our products are inherently disruptive, delivering
transformative patient outcomes alongside substantial cost efficiencies for
the system, but the journey from concept to commercial scale is, by nature,
lengthy, complex, and highly regulated. Whilst our progress to date has been
strong and our low-cost base remains tightly controlled, the Group requires
near-term financing in order to meet our liabilities as they fall due. The
£1m shareholder loan, now close to finalisation, will provide important
interim funding as we plan for a longer term solution to the Group's financing
needs.
I would like to extend my thanks to our people, collaborators, shareholders
and distributors for their support and I look forward to our Group continuing
to grow and lead in emergency care pharmacogenetic testing.
Dr Gino Miele
Chief Executive Officer
Financial Review
Revenue and other income for the year was £1m (2024: £0.5m) mainly due to
the MT-RNR1 test in routine use as part of the NICE EVA evidence generation
plan.
Diagnostics (Scientific, Engineering and Software) costs were £4.2m (2024:
£4.2m) as we continue to invest in commercial stage product development and
the CE-IVD CYP2C19 regulatory approval. Administration costs were £2.1m
(2024: £1.6m) increasing due to our strategic shift towards focussed
commercial activities. The operating loss for the year was £5.4m (2024:
£5.3m).
Finance costs and income
Finance costs were £0.09m (2024: £2.5m) the prior year included a of £1.85m
non-cash fair value adjustment in respect of the derivative financial
instrument that was settled in full during that year and the transaction costs
relating to the share issue of £0.57m. Finance income was £0.04m (2024:
£0.03m).
Taxation
The Group investment in R&D falls within the UK Government's R&D tax
relief scheme for small and medium sized companies where it meets the
qualifying criteria and as the Group did not make a profit in the year it is
collected in cash following submission of tax returns. The £0.4m (2024:
£0.7m) tax receivable on the balance sheet at the year end is not assured to
be received and securing additional working capital is key to obtaining the
refund.
Cash resources
Net cash outflow from operating activities before taxation was £5.6m (2024:
£4.6m). The operating loss cashflows before working capital movements were
£5.2m (2024: £5m) with a working capital outflow of £0.4m (2024: £0.4m
inflow), as the prior year saw a £0.5m increase in trade and other payables.
The tax credit received was £0.5m (2024: £0.8m) and relates to cash received
under the UK Government's R&D tax relief scheme. In 2024 the tax credit
was estimated on the basis that the Group would benefit from the new enhanced
rates afforded to R&D intensive companies. The non-cash fair value
movement on the derivative financial instrument resulted in the R&D
intensive conditional not being achieved.
Capital expenditure in the period was £0.02m (2024: £0.03m) and the proceeds
from investment funding, net of transaction costs were £1.1m (2024: £6.6m).
The decrease in cash for the year was £4m (2024: £2.6m increase) meaning a
closing cash position of £1.2m (2024: £5.2m).
Funding
The equity fund raise provided a £1.1m net capital injection in April 2025
and the Company has a debt free balance sheet at the year end (2024: £nil).
Post year end, the Group conditionally raised £3.6m in equity funding, with
potential for a further up to £7.3m to be received in proceeds from connected
warrants. However, only £0.8m was received as the requisite shareholder
approval was not secured at the general meeting held on 15 October 2025. At
that time, the equity financing represented the only viable option available
to the Group. Subsequently, the Group has continued constructive engagement
with its largest shareholder, and heads of terms for a £1m loan have recently
been agreed with final documentation now close to finalisation.
Balance sheet
Fixed assets were £0.1m (2024: £0.2m) and did not include right to use lease
assets (2024: £0.02m).
Current assets of £2.7m (2024: £6.6m), the reduction was primarily
attributable to the cash balance of £1.2m (2024: £5.2m). Inventories of
£0.4m (2024: £0.4m), consisted mainly of finished goods and raw materials
used in manufacturing and R&D. The remainder of current asset values
were in receivables of £0.7m (2024: £0.4m) and the tax receivable was £0.4m
(2024: £0.7m) for the current year Corporation Tax Research and Development
tax claim.
Current liabilities were £1.4m (2024: £1.4m) and consists of trade and other
payables.
Net assets closed at £1.4m (2024: £5.4m) and the movement in the accumulated
losses reserve for the year was £5.2m (2024: £5.2m).
Going concern
The Directors have considered the Group's revenue and cost forecasts in the
business plans for the period to June 2027 and concluded that it is necessary
to draw attention to the key assumptions regarding financing and revenue
generation. The cash position of the Group on 30 November was £0.32m, with
a projected average monthly cash burn of c.£0.35m, it is evident that
additional financing is required in the very near term in order to meet its
liabilities as they fall due and to continue as a going concern.
The Group conditionally raised £3.6m in equity funding, with potential for a
further up to £7.3m to be received in proceeds from warrants. However,
only £0.8m was received as the requisite shareholder approval was not secured
at the general meeting held on 15 October 2025. At that time, the equity
financing represented the only viable option available to the Group.
Subsequently, the Group has continued constructive engagement with several
shareholders, with the ultimate aim of ensuring the Group has the financial
and other resources it needs to deliver for patients and shareholders.
The Directors are reasonably confident, based on the progress of these
discussions, that the necessary financing will be obtained and has agreed
heads of terms for a £1m loan with its major shareholder. As at the date of
approval of these financial statements, no binding agreements have been
finalised. As a result, the successful completion of the financing is not
wholly within the control of the Group and therefore, in conjunction with the
inherent uncertainty with regards to revenue generation, represents a material
uncertainty that may cast significant doubt on the Group's ability to continue
as a going concern.
As described in the accounting policies, we continue to adopt a going concern
basis for the preparation of the accounts, but the above factor represents a
material uncertainty that may cast significant doubt on the Group and
Company's ability to continue as a going concern.
Russ Shaw
Chief Financial Officer
Consolidated Statement of Comprehensive Income
for the year ended 30 June 2025
Note Year ended Year ended
30 June 30 June
2025 2024
£'000 £'000
Continuing operations
Revenue and other income 2 954 501
Diagnostics costs (4,233) (4,175)
Administrative costs (2,101) (1,638)
Operating loss (5,380) (5,312)
Finance costs 3 (89) (2,468)
Finance income 3 43 30
Loss on ordinary activities before taxation (5,426) (7,750)
Taxation 4 195 675
Loss for the financial year (5,231) (7,075)
Loss/total comprehensive expense for the financial year (5,231) (7,075)
Loss per share (pence)
- Basic and diluted 5 (0.9p) (4.7p)
Consolidated Balance Sheet
as at 30 June 2025
Note 30 June 30 June
2025 2024
£'000 £'000
Assets
Non-current assets
Property, plant and equipment 130 174
130 174
Current assets
Inventories 428 381
Trade and other receivables 679 382
Current tax asset 396 675
Cash and cash equivalents 1,182 5,188
2,685 6,626
Total assets 2,815 6,800
Liabilities
Current liabilities
Trade and other payables (1,377) (1,422)
Lease liabilities - (19)
(1,377) (1,441)
Total liabilities (1,377) (1,441)
Net assets 1,438 5,359
Equity
Called-up equity share capital 7 9,373 8,147
Other reserves 8 54,740 54,656
Accumulated losses (62,675) (57,444)
Total equity 1,438 5,359
Consolidated Statement of Changes in Equity
for the year ended 30 June 2025
Share Other Accumulated Total
capital
reserves
equity
losses
£'000 £'000
£'000
£'000
Balance at 30 June 2023 1,485 52,777 (52,221) 2,041
Transactions with owners in their capacity as owners:
Share issue: January 2024 4 13 - 17
Share issue: June 2024 6,000 - - 6,000
Investment funding arrangement, net of transaction costs 658 1,824 - 2,482
Equity-settled share-based payments - 42 - 42
Transactions settled directly in equity 6,662 1,879 - 8,541
Total comprehensive loss for the year - - (7,075) (7,075)
Settlement of Financial Derivative Liability 1,852 1,852
Balance at 30 June 2024 8,147 54,656 (57,444) 5,359
Transactions with owners in their capacity as owners:
Share issue: April 2025 1,226 - - 1,226
Equity-settled share-based payments - 84 - 84
Transactions settled directly in equity 1,226 84 - 1,310
Total comprehensive loss for the year - - (5,231) (5,231)
Balance at 30 June 2025 9,373 54,740 (62,675) 1,438
Consolidated Cash Flow Statement
for the year ended 30 June 2025
Note Year ended Year ended
30 June 30 June
2025 2024
£'000 £'000
Cash flows from operating activities
Loss on ordinary activities before taxation (5,426) (7,750)
Depreciation, amortisation and impairment 50 54
Depreciation, right-of-use assets 17 193
Finance costs 89 2,468
Finance income (43) (30)
Share-based payment 84 59
Operating loss before changes in working capital (5,229) (5,006)
(Increase) / decrease in inventories (47) 144
Increase in trade and other receivables (297) (224)
(Decrease) / increase in trade and other payables (45) 487
Net cash outflow from operating activities before taxation (5,618) (4,599)
Tax received 474 831
Net cash outflow from operating activities (5,144) (3,768)
Cash flows from investing activities
Finance income 43 30
Acquisition of plant and equipment (23) (29)
Net cash inflow from investing activities 20 1
Cash flows from financing activities
Proceeds from the investment placing agreement 6 - 1,200
Transaction costs relating to investment placing agreement - (48)
Proceeds from share issue 1,226 6,000
Transaction costs relating to share issue (89) (566)
Repayment of lease liabilities (19) (222)
Net inflow from financing activities 1,118 6,364
Net (decrease) / increase in cash equivalents (4,006) 2,597
Effects of exchange rate changes on cash and cash equivalents - (10)
Cash and cash equivalents at beginning of year 5,188 2,601
Cash and cash equivalents at end of year 1,182 5,188
Analysis of net funds
Cash at bank and in hand 1,182 5,188
Net cash 1,182 5,188
Notes to the Financial Information
for the year ended 30 June 2025
General information
genedrive plc ('the Company') is a company incorporated and domiciled in the
UK. The registered head office is The Incubator Building, Grafton Street,
Manchester M13 9XX, United Kingdom.
genedrive plc and its subsidiaries (together, 'the Group') is a
pharmacogenetic testing company developing and commercialising a low cost,
rapid, versatile and simple to use point of need pharmacogenetic platform for
the diagnosis of genetic variants.
genedrive plc is a public limited company, whose shares are listed on the
London Stock Exchange Alternative Investment Market.
1. Significant accounting policies
The financial information for the year ended 30 June 2024 has been extracted
from the Group's audited statutory financial statements which were approved by
the Board of Directors on 28 November 2024, and which have been delivered to
the Registrar of Companies for England and Wales. The report of the auditor on
these financial statements was unqualified, did not contain a statement under
Section 498(2) or Section 498(3) of the Companies Act 2006.
The report of the auditor on the 30 June 2025 statutory financial statements
was unqualified, did not contain a statement under Section 498(2) or Section
498(3) of the Companies Act 2006, but did draw attention to the Group's
ability to continue as a going concern by way of a material uncertainty
paragraph.
The information included in this announcement has been prepared on a going
concern basis under the historical cost convention as modified by the
revaluation of financial assets and financial liabilities (including
derivative instruments) at fair value through profit or loss, and in
accordance with UK-adopted International Accounting Standards.
The information in this announcement has been extracted from the audited
statutory financial statements for the year ended 30 June 2025 and as such,
does not constitute statutory financial statements within the meaning of
section 435 of the Companies Act 2006 as it does not contain all the
information required to be disclosed in the financial statements prepared in
accordance with UK-adopted International Accounting Standards.
This announcement was approved by the board of directors on 05 December 2025
and authorised for issue via RNS.
Going concern
The Group's business activities, market conditions, principal risks and
uncertainties along with the Group's financial position are described in the
full annual accounts. The Group funds its day-to-day cash requirements from
existing cash reserves, revenue generation and other income. These matters
have been considered by the Directors in forming their assessment of going
concern.
The Directors have considered the Group's revenue and cost forecasts in the
business plans for the period to June 2027 and concluded that it is necessary
to draw attention to the key assumptions regarding financing and revenue
generation. The cash position of the Group on 30 November was £0.32m, with
a projected average monthly cash burn of c.£0.35m, it is evident that
additional financing is required in the very near term in order to meet its
liabilities as they fall due and to continue as a going concern.
The Group conditionally raised £3.6m in equity funding, with potential for a
further up to £7.3m to be received in proceeds from connected warrants.
However, only £0.8m was received as the requisite shareholder approval was
not secured at the general meeting held on 15 October 2025. At that time,
the equity financing represented the only viable option available to the
Group. Subsequently, the Group has continued constructive engagement with
several shareholders, with the ultimate aim of ensuring the Group has the
financial and other resources it needs to deliver for patients and
shareholders.
The Directors are reasonably confident, based on the progress of these
discussions, that the necessary financing will be obtained and has agreed
heads of terms for a £1m loan with its major shareholder. As at the date of
approval of these financial statements, no binding agreements have been
finalised. As a result, the successful completion of the financing is not
wholly within the control of the Group and therefore, in conjunction with the
inherent uncertainty with regards to revenue generation, represents a material
uncertainty that may cast significant doubt on the Group's ability to continue
as a going concern.
As described in the accounting policies, we continue to adopt a going concern
basis for the preparation of the accounts, but the above factor represents a
material uncertainty that may cast significant doubt on the Group and
Company's ability to continue as a going concern.
2. Operating segments
For internal reporting and decision-making, the Group is organised into two
segments, Diagnostics and Corporate. Diagnostics is commercialising the
Genedrive® point-of need molecular testing platform. In future periods, and
as revenue grows, the Group may review management account information by type
of assay and thus split out Diagnostics into segments - however, for now, the
single segment is appropriate.
The chief operating decision-maker primarily relies on turnover and operating
loss to assess the performance of the Group and make decisions about resources
to be allocated to each segment. Geographical factors are reviewed by the
chief operating decision-maker, but as substantially all operating activities
are undertaken in the UK, geography is not a significant factor for the Group.
Accordingly, only sales have been analysed into geographical statements.
The results of the operating division of the Group are detailed below.
Business segments Diagnostics Corporate Total
segment costs £'000
£'000 £'000
Year ended 30 June 2025
Revenue and other income 954 - 954
Costs (4,233) (2,101) (6,334)
Trading loss (3,279) (2,101) (5,380)
Net finance costs (46)
Loss on ordinary activities before taxation (5,426)
Taxation 195
Loss for the financial year (5,231)
Total comprehensive expense for the year (5,231)
Business segments Diagnostics Corporate Total
segment costs £'000
£'000 £'000
Year ended 30 June 2024
Revenue and other income 501 - 501
Costs (4,175) (1,638) (5,813)
Trading loss (3,674) (1,638) (5,312)
Net finance costs (2,438)
Loss on ordinary activities before taxation (7,750)
Taxation 675
Loss for the financial year (7,075)
Total comprehensive expense for the year (7,075)
Additions to non-current assets: Diagnostics segment £20k (2024: £23k) and
Corporate costs £3k (2024: £6k).
Geographical segments
The Group's operations are located in the United Kingdom. The following table
provides an analysis of the Group's revenue and other income by customer
location:
All on continuing operations Year ended Year ended
30 June
30 June
2025
2024
£'000 £'000
United Kingdom 931 411
Europe 2 74
Rest of the world 21 16
954 501
Revenues from one customer accounted for more than 10% of total revenue in the
current year (2024: three).
3. Finance income and costs
Year ended Year ended
30 June
30 June
2025
2024
£'000 £'000
Interest income on bank deposits 43 30
Year ended Year ended
30 June
30 June
2025
2024
£'000 £'000
Transaction costs relating to share issue (89) (566)
Transaction costs relating to investment placing agreement (note 6) - (38)
Movement in fair value of derivative financial instrument (note 6) - (1,852)
Finance charge on leased assets - (12)
Finance costs (89) (2,468)
4. Taxation
(a) Recognised in the income statement
Current tax:
Year ended Year ended
30 June
30 June
2025
2024
£'000 £'000
Research and development tax credits (195) (675)
Total tax credit for the year (195) (675)
(b) Reconciliation of the total tax credit
The tax credit assessed on the loss for the year is lower (2024: lower) than
the weighted average applicable tax rate for the year ended 30 June 2025 of
25% (2024: 25%). The differences are explained below:
Year ended Year ended
30 June
30 June
2025
2024
£'000 £'000
Loss before taxation on continuing operations (5,426) (7,750)
Tax using UK corporation tax rate of 25% (2024: 25%) (1,357) (1,938)
Adjustment in respect of R&D tax credit claimed - (61)
Items not deductible / (taxable) for tax purposes - permanent 398 603
Items not deductible for tax purposes - temporary (43) (2)
Deferred tax not recognised 606 723
Adjustments to tax charge in respect of previous periods 201 -
Total tax credit for the year (195) (675)
No deferred tax assets are recognised at 30 June 2025 (2024: £nil). Having
reviewed future profitability in the context of trading losses carried, it is
not probable that there will be sufficient profits available to set against
brought forward losses.
The Group had trading losses, as computed for tax purposes, of approximately
£28,750k (2024: £23,942k) available to carry forward to future periods; this
excludes management expenses.
5. Earnings per share
2025 2024
£'000 £'000
Loss for the year after taxation (5,231) (5,150)
Group 2025 2024
Number Number
Weighted average number of ordinary shares in issue 562,852,017 151,441,746
Potentially dilutive ordinary shares - -
Adjusted weighted average number of ordinary shares in issue 562,852,017 151,441,746
Loss per share on continuing operations
- Basic (0.9)p (4.7)p
- Diluted (0.9)p (4.7)p
The basic earnings per share is calculated by dividing the earnings
attributable to ordinary shareholders for the year by the weighted average
number of ordinary shares in issue during the year.
As the Company is loss-making, no potentially dilutive options have been added
into the EPS calculation. Had the Company made a profit in the period:
Group 2025 2024
Number
Number
Potentially dilutive shares from share options and warrants 8,616,321 8,616,321
Potentially dilutive shares within the SIP 1,112,137 551,835
Potentially dilutive ordinary shares 9,728,458 9,168,156
6. Derivative Financial Instruments
On 31 March 2023, the Company entered into an Investor Placing Agreement for
up to £5m with RiverFort Global Opportunities PCC Limited ("Noteholders").
The instrument was entered by way of an initial drawdown in the amount of £2m
and related issuance of 6,250,000 shares priced at nominal value of 1.5 pence
to be used to facilitate the settlement of amounts advanced under the
investment agreement Further drawdowns totalling £1.5m were made and the
remaining balance as at the balance sheet date of £1.5m under the Facility is
available for the Company to drawdown, at its discretion, but subject to there
being no trading Material Adverse Change:
(a) the Share Price falling below 16 pence
(b) the 3 day average volumes traded being less than £100,000
(c) the 10 day average trading volumes being less than £100,000 and
(d) the amount outstanding under the Facility being no more than £700,000;
Any outstanding liability after the disposal by the Noteholder of the shares
issued in exchange for each drawdown can be settled at the discretion of the
Noteholder by further subscription to the Company's shares. The Company can
also elect to settle the outstanding liability with a 10% premium on the
balance. As the value of the outstanding amount is expected to move with the
Company's share price, the instrument met the definition of a derivative and
is initially recognised at fair value with changes in fair value recognised in
profit and loss.
There was no outstanding liability as at 30 June 2025 (2024: £nil).
Pursuant to the facility, the Noteholders were granted warrants exercisable at
1.5p to subscribe for 8,616,321 shares. All warrants remain outstanding at
30 June 2024 and can be exercised at any time from the date of issue for a
period of four years.
The warrants are initially valued using a model which utilised observable
market factors such as the share price at the date of the grant, the term of
the award, the share price volatility and the risk-free interest rate (Level 2
inputs).
The Company made no drawdowns during the financial year. The prior year the
Company drew down £1.2m, which has all been settled by the issue of equity
and received a non-cash fair value adjustment, which can be summarised as
follows:
Derivative financial liability Finance Equity Warrants Total
£'000 costs £'000 £'000 £'000
£'000
At 30 June 2023 1,290
Proceeds 947 - - 253 1,200
Transaction costs - (38) - (10) (48)
947 (38) - 243 1,152
Equity Settlement (4,091)
Fair value movement 1,854
At 30 June 2024 -
In the year to June 2023 the transaction costs include fees of £80,000
payable to the Noteholders that were settled by issue of shares and included
in share premium (note 8).
The derivative has been marked to market through profit or loss, immediately
prior to conversion, such that the time value of money on the option is
captured in the income statement.
The derivative financial liability was settled in full in the year ended 30
June 2024.
7. Share capital
Allotted, issued and fully paid:
Number £'000
Balance at 30 June 2023 99,049,946 1,485
Share issue - equity-settled share-based payments 260,870 4
Share issue 443,830,665 6,658
Balance at 30 June 2024 543,141,481 8,147
Share issue 81,753,927 1,226
Balance at 30 June 2025 624,895,408 9,373
In April 2025 the Company issued 81,753,927 shares as part of a placing and
open offer to shareholders for net proceeds of £1.137m.
Over the months of May and June 2024 the Company issued 400,000,000 shares as
part of a placing and open offer to shareholders for net proceeds of £5.434m.
During the prior year the Company issued 43,830,665 shares with a nominal
value of £658,000 as part of the Investor Placing Agreement detailed in note
6.
8. Other reserves
Share premium account Shares to be issued Employee share incentive plan Share Reverse acquisition reserve Total equity
reserve
options reserve
£'000 £'000
£'000 £'000
£'000 £'000
Balance at 30 June 2023 53,336 477 (196) 1,656 (2,496) 52,777
Investment funding arrangement (note 6) 1,581 243 - - - 1,824
Equity-settled share-based payments 13 - - 42 - 55
Transactions settled directly in equity 1,594 243 - 42 - 1,879
Balance at 30 June 2024 54,930 720 (196) 1,698 (2,496) 54,656
Equity-settled share-based payments - - - 84 - 84
Transactions settled directly in equity - - - 84 - 84
Balance at 30 June 2025 54,930 720 (196) 1,782 (2,496) 54,740
Shares to be issued relates to the warrants issued; full details are contained
in note 6.
The employee share incentive plan reserve is the historic cost of shares
purchased to satisfy share rights under the Share Investment Plan ("SIP") of
£196k. The Company no longer buys shares to satisfy the SIP.
The reverse acquisition reserve arises as a difference on consolidation under
merger accounting principles and is solely in respect of the merger of the
Company and Epistem Ltd, during the year ended 30 June 2007.
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