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REG - Genedrive PLC - Interim Results to 31 December 2025

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RNS Number : 5382Y  Genedrive PLC  30 March 2026

30 March 2026

genedrive plc

("genedrive" or the "Company")

Interim results to 31 December 2025

 

-       Capitalised to expand commercial operations in the UK and
internationally

-       Focused on commercial delivery across markets in the near-term

 

genedrive plc (LSE: GDR), the point of care pharmacogenetic testing company,
announces unaudited interim results for the six months to 31 December 2025.

 

Operational Highlights (including post period end)

 

Genedrive® CYP2C19

 * Genedrive® CYP2C19 ID Kit in use at Salford Hyper Acute Stroke Unit, the
largest in England, initially as part of a national pilot programme to support
broader healthcare system adoption

 * NHS implementation guidance published for CYP2C19 testing in stroke pathways,
supporting local adoption and including the Genedrive® CYP2C19 ID Kit as a
rapid testing option

 * Accepted onto the NHS Dynamic Procurement System (DPS) to support NHS adoption

 * 12-Month expansion of use study underway to include Acute Coronary Syndrome
(ACS), led by the Manchester University NHS Foundation Trust

 * Scotland's NHS Grampian and Western Isles assessing Genedrive® CYP2C19 ID Kit
as a "test of change" to support adoption for remote and rural patients across
Scotland

 * International market access routes and reimbursement strategies assessed in
Europe and the Middle East

 * US 510(k) pathway defined for US market entry, following completion of
required studies

 

Genedrive® MT-RNR1

 * Genedrive® MT-RNR1 ID Kit currently in use across 14 hospitals in the UK as
part of the ongoing PALOH-UK programme for NICE Evidence Generation

 * More than 30 critically ill babies identified with MT-RNR1 variant, enabling
alternative antibiotic prescription and reducing risk of
aminoglycoside-induced lifelong hearing loss (AIHL)

 * Accepted onto the NHS Dynamic Procurement System (DPS) to support NHS adoption

 * Scotland national phased roll-out underway with first implementation at the
Royal Hospital for Children in Glasgow with Royal Alexandra Hospital and
Princess Royal Maternity Hospital expected to roll out in 2026

 * Implemented at Dublin's Rotunda Hospital to support wider routine clinical use
nationally

 * Kingdom of Saudi Arabia's Ministry of Health signed a Memorandum of
Understanding for Medical Equipment Technology to implement a national pilot
study using the Genedrive® MT-RNR1 ID kit under the "Generations Hear"
national initiative

 

Financial Highlights (including post period)

 * Equity fundraise raising circa £4.9m after expenses completed in March 2026
of which £0.6m received in February 2026 which funded near-term working
capital requirements

 * £0.5m shareholder loan converted into equity concurrently with the equity
fundraise

 * Cash of £3.65m as at 27 March 2026 and debt free

 * Revenue and other income of £0.57m (H1 2024/5: £0.35m)

 * Diagnostics costs of £2.3m (H1 2024/5: £2.1m)

 * Operating loss of £2.6m (H1 2024/5: £2.6m)

 * Cash of £0.4m as at 31 December 2025 (30 June 2025: £1.2m)

 

Gino Miele, CEO of genedrive plc, commented: "Looking ahead, the Company is
well positioned to build on the progress achieved during the period. The Board
remains focused on executing the commercialisation of Genedrive® CYP2C19 and
MT-RNR1 across the UK, Europe, and Middle East, advancing regulatory
milestones including the US FDA pathways, and continuing to generate
real-world evidence to support broader commercial adoption in the UK.

 

"The strengthened financial position following the recent fundraise provides
the resources and stability to support operational expansion, product
development, and market access initiatives. We will continue to engage with
NHS stakeholders, ICBs, senior NHS and government stakeholders and
international partners to drive adoption and implementation of our
technologies, while closely monitoring market and funding dynamics to ensure
resilience and adaptability in an evolving healthcare environment.

 

"Whilst market conditions and local NHS funding constraints have been
challenging, the Board anticipates an improvement in the new NHS financial
year (commencing in April) in a phased process that could take up to 12
months. The Board is confident in the strategy and remains committed to
delivering innovative diagnostic solutions, expanding market reach, and
generating sustainable value for shareholders."

 

 genedrive plc
                                                        +44 (0)161 989 0245
 Gino Miele: CEO / Russ Shaw: CFO
                                                        https://investors.genedrive.com/s/e0025c
                                                        (https://investors.genedrive.com/s/e0025c)

 Peel Hunt LLP (Nominated Adviser and Broker)
                                                        +44 (0)20 7418 8900
 James Steel

 5654 & Company  (Media & Investor Relations)           genedrive@5654.co.uk
 Matthew Neal                                           +44 (0)7917 800 011
 Melissa Gardiner                                       +44 (0)7757 697357

 

Subscribe to our news alert service: https://investors.genedrive.com/s/efea03
(https://investors.genedrive.com/s/efea03)

 

About genedrive plc (http://www.genedrive.com (http://www.genedrive.com) ).

 

genedrive plc is a UK-based, commercial-stage pharmacogenetic testing company
focused on rapid, point-of-care diagnostic tests to guide safe and effective
drug prescription in emergency and acute care settings.

 

genedrive's proprietary technology platform enables clinicians to prescribe
safer and more effective therapies based on a patient's genetic profile,
supporting improved outcomes while reducing pressure on healthcare systems,
lowering downstream healthcare costs through the prevention of avoidable
complications and earlier, more effective intervention

 

The Company has two CE-IVD approved and NICE-recommended tests in NHS clinical
use. The Genedrive® CYP2C19 ID Kit identifies stroke patients who will not
respond to the current standard of care, Clopidogrel, used to reduce risk of
secondary stroke. The Genedrive® MT-RNR1 ID Kit helps prevent
antibiotic-induced hearing loss (AIHL) in newborns, enabling treatment
decisions within actionable timeframes at the point of care.

 

Headquartered in Manchester, genedrive is focused on scaling UK-developed
precision diagnostics within routine care and leveraging real-world evidence
to support broader international adoption and commercial growth.

CHIEF EXECUTIVE OFFICER'S AND CHAIRMAN'S REPORT

Introduction

During the period, the Company has remained focused on advancing its
pharmacogenetic testing solutions, while navigating an ever-evolving
healthcare landscape. The UK National Health Service (NHS) continues to
undergo structural and strategic transformation, with Integrated Care Boards
(ICBs) assuming an increasingly central role in commissioning and funding
decisions. At the same time, broader geopolitical and economic factors have
influenced both market access and capital availability. Despite these
dynamics, we have made meaningful progress in positioning ourselves for near
and long-term commercial growth.

 

Post-period funding and scale up

A key recent achievement has been successfully securing £5.75m (including
loan conversion) of funding post period end, with a cornerstone of strong
support from two long term investors, David Nugent and Robert English. This
capital raise represents a significant milestone for the Company,
strengthening the balance sheet and providing the necessary resources and a
stable shareholder base to deliver on our commercialisation activities,
support ongoing clinical and regulatory workstreams, and expand market
engagement. The Board believes this funding round reflects investor confidence
in our technology, strategy, and the long-term opportunity of the business.

 

The Company's post-period capital raise is focused on supporting continued
near-term commercialisation and market expansion activities across the UK,
Europe and the Middle East for both pharmacogenetic tests. Key priorities
include progressing in-country registrations in target geographies and
supporting pilot phase implementations to drive early adoption and real-world
evidence generation.

 

Proceeds from the fundraise will also support operational, strategic and
product development expenditure, including:

 * FDA 510(k) submission for Genedrive® CYP2C19 currently anticipated around
June 2026, pending completion of studies, with an expected 3-4 month review
period post submission

 * Manufacturing scale-up and delivery of operational efficiencies

 * User-led, on-market refinements to enhance product usability and workflow
integration

 * Translation and expansion of the Company's IP to include a laboratory-based
CYP2C19 genotyping assay alongside the point-of-care offering

The Board believes these initiatives position the Company to transition from
early commercial activity into a more scalable revenue phase, supported by the
strengthened financial position post the recent fundraise.

 

Product performance

Genedrive® CYP2C19

 

Product and operational performance

The Genedrive® CYP2C19 ID Kit is currently in use at Salford Hyper Acute
Stroke Unit, the largest in England, initially as part of a national pilot
programme to support broader commercial adoption across healthcare systems.

 

In December, Genedrive's CYP2C19 ID Kit was implemented into Scottish NHS
Grampian (Dr. Gray's Hospital, Elgin) and NHS Western Isles (Western Isles
Hospital, Stornoway) under a "test of change" pilot programme for stroke
patients in remote and rural settings. Whilst the pathway for CYP2C19
genotyping in NHS Scotland currently relies on laboratory testing, the Centre
For Sustainable Delivery, commissioned by the Scottish Government, is
assessing the impact of rapid genetic testing using the Genedrive CYP2C19 ID
kit, which will run for approximately one year and include c.400 patients. The
evidence gathered from this programme will support the business case for wider
deployment across Scotland.

 

Regulatory and market access

In December, the NHS implementation guide for CYP2C19 genotype testing to
guide Clopidogrel use after ischaemic attack (IS) or transient ischaemic
attack (TIA) was published, confirming the value of rapid testing solutions to
stroke patients.

 

This guidance builds on the earlier National Institute for Health and Care
Excellence (NICE) recommendation for CYP2C19 testing, which includes the
Genedrive® CYP2C19 ID Kit as the preferred rapid testing option, as well as
interim results from a national pilot programme comparing both laboratory and
"rapid testing" approaches.

 

The interim results, presented at the UK Stroke Forum in November by authors
from NHS England (NHSE) Network of Excellence in Pharmacogenomics, the NHSE
Genomics Unit, NHSE National Stroke Programme, and Manchester Centre for
Genomic Medicine, demonstrated that implementation of Genedrive® CYP2C19
testing was feasible, scalable and effective in providing immediate
availability of results during acute clinical settings.

 

Genedrive® CYP2C19 ID Kit has been 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.

 

genedrive continues to evaluate CYP2C19 testing in other indications. As
announced in May, a 12-month expansion of use study is currently underway to
include Acute Coronary Syndrome (ACS), led by the Manchester University NHS
Foundation Trust in collaboration with the Genotype Guided Primary Coronary
Intervention ("GUIDE PCI") programme and the British Heart Foundation ("BHF")
Centre of Excellence. The study is assessing the value and feasibility of
rapid point of care CYP2C19 testing in cardiovascular disease to improve
patient outcomes.

 

Beyond the UK, genedrive has continued to progress market expansion across
Europe, the US and the Middle East. Key priorities include progressing
in-country registrations in target regions and supporting pilot phase
implementations to drive early adoption and real-world evidence generation. In
the US, the Company defined the 510(k) pathway via FDA Breakthrough Device.

 

Genedrive® MT-RNR1

 

Product and operational performance

The Genedrive® MT-RNR1 ID Kit currently in use across 14 hospitals in the UK
as part of the ongoing PALOH-UK programme and, to date, more than 30
critically ill babies have been identified with MT-RNR1 variant, enabling
alternative antibiotic prescription and reducing the risk of
aminoglycoside-induced lifelong hearing loss (AIHL).

 

In December 2025, Scotland started a national phased roll-out of Genedrive®
MT-RNR1 ID Kits to all NHS Scotland Health Boards with neonatal units. The
first implementation was at the Royal Hospital for Children in Glasgow, with
Royal Alexandra Hospital and Princess Royal Maternity Hospital expected follow
throughout 2026.

 

In November 2025, the Genedrive® MT-RNR1 ID Kit was implemented in the
Republic of Ireland at Dublin's Rotunda Hospital Neonatal Intensive Care
Unit. Funded initially by the Rotunda Foundation under the "Early
Identification of Susceptibility to Gentamicin Induced Hearing Loss"
programme, Rotunda Hospital admits approximately 1,400 babies each year into
its NICU.

 

Regulatory and market access

The PALOH-UK programme has continued to progress strongly during the period,
demonstrating the strong clinical utility and feasibility of rapid MT-RNR1
Testing in neonatal care. This reinforces the potential for genedrive's
technology to become a valuable tool within modern diagnostic pathways. The
Company has continued to invest in product improvement to further strengthen
our positioning ahead of broader market rollout.

 

NICE has indicated July 2027 as the anticipated timeline by which PALOH-UK
evidence generation outcomes would be reviewed and any new guidance issued
(e.g. Conditional to full). While this extends the formal timeline for
expected full recommendation in the UK, with this current clarity we are
continuing to focus on UK sites able to procure from locally available funds,
whilst the case for structured planning for reimbursement for wider adoption
continues.

 

Genedrive® MT-RNR1 ID Kit has been 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.

Beyond the UK, genedrive has continued to progress market expansion across key
geographies. In October, the Kingdom of Saudi Arabia's Ministry of Health
signed a Memorandum of Understanding with our distribution partner, iDEAL iDEA
for Medical Equipment Technology to implement a national pilot study using the
Genedrive® MT-RNR1 kit under the "Generations Hear" national initiative. In
the US, FDA submission under the de novo Breakthrough Designation route is
being planned.

 

The NHS 10-Year plan

The NHS 10-Year Plan places prevention firmly at the core of future healthcare
delivery. This strategic direction aligns closely with the Company's value
proposition, particularly in enabling early detection and proactive patient
management to prevent avoidable healthcare complications.  With a focus on
spending decisions at ICB level, the Company is pursuing engagement with ICB
stakeholders to navigate these dynamics, drive local implementation, and
ensure alignment with regional priorities, positioning genedrive to benefit
from future adoption pathways.

 

Middle East

The Middle East remains a key target market and the ongoing conflict in the
region has introduced short-term uncertainty and operational challenges. The
Company is closely monitoring developments while maintaining engagement with
partners and stakeholders where appropriate. Despite near-term disruption, we
continue to view the region as strategically important over the medium to long
term.

 

People

The Board would like to recognise and thank our highly skilled and dedicated
team, whose commitment and resilience have been instrumental in progressing
the Company's strategy during a challenging period.

 

The Company's commercial team reduced from 11 to 4 people, primarily driven by
funding constraints, which impacted staff retention and limited recruitment
activity. While this has created short-term capacity challenges, the Company
has remained focused on prioritising core activities and maintaining
operational effectiveness.

 

The Board intends to rebuild capability in line with the Company's financial
position and strategic priorities following the successful post-period
fundraise.

 

Following the recent fundraise, Tom Lindsay has retired as Non-Executive
Director, and we would like to express our sincere thanks for his valuable
contribution and service to the Company.

 

Outlook

Looking ahead, the Company is well funded to build on the progress achieved
during the period. The Board remains focused on executing the
commercialisation of Genedrive® CYP2C19 and MT-RNR1 across the UK, Europe,
and Middle East, advancing regulatory milestones including the FDA pathways,
and continuing to generate real-world evidence to support broader commercial
adoption in the UK.

 

The strengthened financial position following the recent fundraise provides
the resources and stability to support operational expansion, product
development, and market access initiatives. We will continue to engage with
NHS stakeholders, ICBs, and international partners to drive adoption and
implementation of our technologies, while closely monitoring market and
funding dynamics to ensure resilience and adaptability in an evolving
healthcare environment.

 

The Company has secured FY26 visible revenue of approximately £0.8m and
expects this to increase progressively, supported by preliminary sales
traction in international territories.

 

Current FY26 revenue visibility is underpinned by:

 * NICE Early Value Assessment (EVA) evidence generation completion and
submission, acting as a key catalyst for broader UK implementation

 * Scotland CYP2C19 proof-of-concept pilot study, alongside phased national
implementation of Genedrive® MT-RNR1 ID Kit (commenced October 2025)

 * Manchester Foundation Trust Acute Coronary Syndrome programme and CYP2C19
rapid genotyping initiative

Whilst current market conditions and local funding constraints have been
challenging, the Board anticipates an improvement from the new NHS financial
year (April) in a phased process that could take up to 12 months. The Board is
confident in the strategy and remains committed to delivering innovative
diagnostic solutions, expanding market reach, and generating sustainable value
for shareholders.

 

On behalf of ourselves and the Board, we would like to thank our employees,
partners, collaborators, and shareholders for their continued support. We look
forward to building on our growing commercial traction and delivering
meaningful impact for patients through our innovative diagnostic solutions.

 

Dr Gino Miele

Chief Executive Officer

 

Dr Ian Gilham

Chairman

30 March 2026

FINANCIAL REVIEW

 

Revenue and other income in the period was £0.57m (H1 2024/5: £0.35m).

 

Diagnostics costs were £2.3m (H1 2024/5: £2.1m, reflecting continued
investment in operational and commercial activities.  Administration costs at
£856k (H1 2024/5: £862k) have remained tightly controlled and in line with
the prior year. The operating loss for the period was £2.6m (H1 2024/5:
£2.6m) with finance income in the period of £3k (H1 2024/5: £41k).

 

After financing costs, the loss before taxation was £2.6m (H1 2024/5:
£2.5m). The loss after taxation decreases to £2.4m (H1 2024/5: £2.3m) after
estimating the six-month taxation credit as £0.2m (H1 2024/5: £0.2m). The
basic loss per share was 0.3p (H1 2024/5: 0.4p).

 

Cash Resources

The operating loss before changes in working capital and provisions for the
period was £2.6m (H1 2024/5:  £2.5m) and working capital reduced by £0.7m
(H1 2024/5: increase £0.6m). Net cash out-flow from operations was £1.8m (H1
2024/5: £3.1m) and as the R&D tax credit was not received in the period
the net cash flow from operating activities was also £1.8m.

 

Cash flows from financing activities consisted of loan proceeds of £0.5m and
net proceeds from share issue of £0.55m (H1 2024/5: outflow £19k).

 

Closing cash was £2.1m (31 December 2024: £2.1m). The cash balance on 27
March 2026 was £3.65m with the FY25 R&D tax credit expected in the coming
weeks. The current level of operating expenditure is circa £0.5m per month
and the cash burn is expected to average at approximately £0.35m per month
for the next six months. The proceeds from the equity fundraise provides the
working capital for the Company to actively pursues a broad range of
commercial opportunities in the UK and internationally.

 

Balance Sheet

Balance sheet net liabilities at 31 December 2025 were £0.4m (30 June 2025:
net assets £1.4m; 31 December 2024: net assets £3.1m) and the consolidated
loss of the period was £2.4m (H1 2024/5: £2.3m).

 

PRINCIPAL RISKS AND UNCERTAINTIES

There are a number of potential risks and uncertainties which could have a
material impact on the Company's performance over the remaining six months of
the financial year and could cause actual results to differ materially from
expected and historical results. The Directors do not consider that these
principal risks and uncertainties have changed materially since publication of
the annual report for the year ended 30 June 2025; a more detailed explanation
of the risks for the Company can be found on page 31 of the annual report.

 

UNAUDITED CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME

For the six months ended 31 December 2025

 

                                                          Six months ended    Six months ended    Year ended
                                                          31 December 2025    31 December 2024    30 June 2025
                                                          Unaudited           Unaudited           Audited
                                                    Note  £000                £000                £000

 Revenue and other income                           (3)   570                 350                 954
 Diagnostics costs                                        (2,333)             (2,058)             (4,233)
 Administrative costs                                     (856)               (862)               (2,101)

 Operating loss                                     (4)   (2,619)             (2,570)             (5,380)

 Finance costs                                      (5)   -                   -                   (89)
 Finance income                                     (5)   3                   41                  43

 Loss on ordinary activities before taxation              (2,616)             (2,529)             (5,426)
 Taxation                                                 175                 200                 195
 Loss for the financial period                            (2,441)             (2,329)             (5,231)

 Total comprehensive expense for the period               (2,441)             (2,329)             (5,231)

 Loss per share (pence)                             (7)
 - Basic                                                  (0.3)p              (0.4)p              (0.9)p
 - Diluted                                                (0.3)p              (0.4)p              (0.9)p

UNAUDITED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

For the six months ended 31 December 2025

 

                                          Share Capital  Other Reserves  Accumulated   Total

                                          (unaudited)    (unaudited)     Losses        (unaudited)

                                          £000           £000            (unaudited)   £000

                                                                         £000

 At 30 June 2024                          8,147          54,656          (57,444)      5,359
 Equity-settled share-based payments      -              40              -             40
 Total comprehensive loss for the period  -              -               (2,329)       (2,329)
 At 31 December 2024                      8,147          54,696          (59,773)      3,070
 Share issue: April 2025                  1,226          -               -             1,226
 Equity-settled share-based payments      -              84              -             84
 Total comprehensive loss for the period  -              -               (2,902)       (2,902)
 At 30 June 2025                          9,373          54,740          (62,675)      1,438
 Share issue: September 2025              60             480             -             540
 Share issue: October 2025                1              9               -             10
 Equity-settled share-based payments      -              38              -             38
 Total comprehensive loss for the period  -              -               (2,441)       (2,441)
 At 31 December 2025                      9,434          55,267          (65,116)      (415)

 

UNAUDITED CONSOLIDATED BALANCE SHEET

As at 31 December 2025

 

                                                                                                                                                                       31 December  31 December  30 June
                                                                                                                                                                       2025         2024         2025
                                                                                                                                                                       (unaudited)  (unaudited)  (audited)
                                                                                                                                                                       £000         £000         £000
 Note
 Non-current assets
 Property, plant and equipment                                                                                                                                         109          145          130
                                                                                                                                                                       109          145          130
 Current assets
 Inventories                                                                                                                                                           341          366          428
 Trade and other receivables                                                                                                                                           346          522          679
 Current tax                                                                                                                                                           571          875          396
 asset
 (6)
 Cash and cash equivalents                                                                                                                                             387          2,098        1,182
                                                                                                                                                                       1,645        3,861        2,685

 Total assets                                                                                                                                                          1,754        4,006        2,815

 Liabilities
 Current liabilities
 Trade and other payables                                                                                                                                              (1,669)      (936)        (1,377)
                                                                                                                                                                       (1,669)      (936)        (1,377)
 Non-current liabilities
 Loans and borrowings                                                                                                                                                  (500)        -            -

 Total liabilities                                                                                                                                                     (2,169)      (936)        (1,377)

 Net (liabilities) / assets                                                                                                                                            (415)        3,070        1,438

 Capital and reserves
 Called-up equity share                                                                                                                                                9,434        8,147        9,373
 capital
 (8)
 Other                                                                                                                                                                 55,267       54,696       54,740
 reserves
 (9)
 Accumulated losses                                                                                                                                                    (65,116)     (59,773)     (62,675)
 Total shareholder equity                                                                                                                                              (415)        3,070        1,438

 

UNAUDITED CONSOLIDATED CASH FLOW STATEMENT
For the six months ended 31 December 2025
 
                                                                  31 December 2025  31 December 2024  30 June

                                                                  (unaudited)       (unaudited)       2025

                                                                                                      (audited)

                                                                  £000              £000              £000
 Cash flows from operating activities
 Loss on ordinary activities before taxation                      (2,616)           (2,529)           (5,426)
 Depreciation and amortisation on non-leased assets               22                26                50
 Depreciation on right-of-use assets                              -                 17                17
 Finance costs                                                    -                 -                 89
 Finance income                                                   (3)               (41)              (43)
 Share - based payment                                            38                40                84
 Operating loss before changes in working capital and provisions  (2,559)           (2,487)           (5,229)
 Decrease / (increase) in inventories                             87                15                (47)
 Decrease / (increase) in trade and other receivables             333               (140)             (297)
 Increase / (decrease) in trade and other payables                292               (486)             (45)
 Net cash outflow from operations                                 (1,847)           (3,098)           (5,618)
 Tax received                                                     -                 -                 474
 Net cash outflow from operating activities                       (1,847)           (3,098)           (5,144)
 Cash flows from investing activities
 Finance income                                                   3                 41                43
 Acquisition of plant and equipment                               (1)               (14)              (23)
 Net cash inflow from investing activities                        2                 27                20
 Cash flows from financing activities
 Proceeds from loans and borrowings                               500               -                 -
 Proceeds from share issue                                        810               -                 1,226
 Transaction costs relating to share issue                        (260)             -                 (89)
 Repayment of lease liabilities                                   -                 (19)              (19)
 Net inflow / (outflow) from financing activities                 1,050             (19)              1,118
 Net decrease in cash equivalents                                 (795)             (3,090)           (4,006)
 Cash and cash equivalents at beginning of period                 1,182             5,188             5,188
 Cash and cash equivalents at end of period                       387               2,098             1,182
 Analysis of net funds
 Cash at bank and in hand                                         387               2,098             1,182

 

NOTES TO THE UNAUDITED INTERIM FINANCIAL STATEMENTS

 

1. General information

 

genedrive plc ('the Company') and its subsidiaries (together 'the Group') is a
pharmacogenetic testing company developing and commercialising a low cost,
rapid, versatile, simple to use and robust point of need pharmacogenetic
platform for the diagnosis of genetic variations. The Company is a public
limited company incorporated and domiciled in the UK. The address of its
registered office is 48 Grafton Street, Manchester, M13 9XX. The Company has
its listing on the London Stock Exchange Alternative Investment Market
(AIM).

 

The financial information for the period ended 31 December 2025 and similarly
the period ended 31 December 2024 has been neither audited nor reviewed by the
auditor. The financial information for the year ended 30 June 2025 has been
based on information in the audited financial statements for that period. The
interim financial statements for the period ended 31 December 2025 do not
constitute statutory accounts as defined in section 434 of the Companies Act
2006. A copy of the statutory accounts for the year ended 30 June 2025 has
been delivered to the Registrar of Companies, the accounts had an unqualified
audit opinion and did not contain a statement under section 498(2) or (3) of
the Companies Act 2006 but did include a reference to a material uncertainty
that might cast significant doubt over the Group's ability to continue as a
going concern, to which the auditor drew attention by way of emphasis.

 

These interim financial statements were approved by the Board of Directors on
30 March 2026.

 

The accounting policies set out below have, unless otherwise stated, been
applied consistently to all periods represented in these consolidated
financial statements.

 

2. Significant accounting policies

 

Basis of accounting

The consolidated interim financial statements consolidate those of the Company
and its subsidiaries (together referred to as the "Group"). They are presented
in pounds sterling, and all values are rounded to the nearest one thousand
pounds (£k) except where otherwise indicated.

 

Subsidiaries are entities controlled by the Group. The financial statements of
subsidiaries are included in the consolidated financial statements from the
date that control commences until the date that control ceases. Transactions
between Group companies are eliminated on consolidation.

 

The accounting policies used in the preparation of the financial information
for the six months ended 31 December 2025 are in accordance with the
recognition and measurement criteria of UK adopted international accounting
standards and are consistent with those which will be adopted in the annual
financial statements for the year ending 30 June 2026. Whilst the financial
information included has been prepared in accordance with the recognition and
measurement criteria of international accounting standards, the financial
information does not contain sufficient information to comply with
international accounting standards. The Group has not applied IAS 34, Interim
Financial Reporting, which is not mandatory for UK AIM listed Groups, in the
preparation of this interim financial report.

 

Going concern

The Board has reviewed the Group's financial position, cash flow forecasts,
and expected revenues. Since the period end, the Company successfully
completed an equity fundraise with net proceeds of £4.9 million providing
significant financial headroom. As at 31 March 2026, the Group expects to hold
cash of £3.5m, the committed revenue for FY26 is approximately £0.8m, and
the average monthly cash burn is expected to be £0.35m for the next six
months.

 

Forecasts have been prepared reflecting planned operational expenditure,
regulatory and commercial activities, and ongoing investment in product
development.

 

The Directors have concluded that it is necessary to draw attention to the
revenue and cost forecasts in the business plans for the period to June
2027.  In order for the Company to continue as a going concern, there is a
requirement to achieve a certain level of sales. If an adequate sales level
cannot be achieved to support the Group and Company, the Directors have the
options to reduce ongoing spend and seek additional financing from investors
or debt providers.

 

The combination of the above factors represents a material uncertainty that
may cast significant doubt on the Group and Company's ability to continue as a
going concern.

 

Accordingly, the Directors have concluded that it is appropriate to continue
to adopt the going concern basis of accounting in preparing these financial
statements. These financial statements do not include the adjustments that
would result if the Group and Company were unable to continue as a going
concern.

 

New accounting standards adopted in the period

There have been no new accounting standards adopted in the period that have
had a material impact on the financial statements.

Estimates

The preparation of interim financial statements requires management to make
judgements, estimates and assumptions that affect the application of
accounting policies and the reported amounts of assets and liabilities, income
and expense. Actual results may differ from these estimates.

 

In preparing these interim financial statements, the significant judgements
made by management in applying the Group's accounting policies and the key
sources of estimation were the same as those that applied to the consolidated
financial statements for the year ended 30 June 2025, with the exception of
changes in estimates that are required in:

 

- determining the provision for taxation; and

- determining the carrying value for inventory

 

Revenue recognition

 

a. Product sales

Sales of goods are recognised when all the performance obligations have been
completed and when the Group entity has no continuing managerial involvement
nor effective control over the goods. The transfer of control of goods can
pass at various points depending on the shipping terms of the contract with
the customer, they can be at collection from a premises or delivery to the
relevant port or customer designated premises. Where items are sold with a
right of return, accumulated experience is used to estimate and provide for
such returns at the time of sale.

 

b. Collaboration and licensing revenue

Contractually agreed upfront payments and similar non-refundable payments in
respect of collaboration or licence agreements which are not directly related
to ongoing research activity are recorded as deferred income and recognised as
revenue over the anticipated duration of the agreement. Where the anticipated
duration of the agreement is modified, the period over which revenue is
recognised is also modified.

 

Non-refundable milestone and other payments that are linked to the achievement
of significant and substantive technological or regulatory hurdles in the
research and development process are recognised as revenue upon the
achievement of the specified milestones.

 

Income which is related to ongoing research activity is recognised as the
research activity is undertaken, in accordance with the contract. Activity is
measured based on progress and milestones and not cost.

 

c. Other income - development grant funding

Income receivable in the form of Government grants to fund product development
is recognised as development grant funding over the periods in which the Group
recognises, as expenses, the related eligible costs which the grants are
intended to compensate and when there is reasonable assurance that the Group
will comply with the conditions attaching to them and that the income will be
received. Government grants whose primary condition is that the Group should
purchase or otherwise acquire non-current assets are recognised as deferred
revenue in the Consolidated Balance Sheet and transferred to the Consolidated
Statement of Comprehensive Income on a systematic and rational basis over the
useful lives of the related assets.

 

Research and development

Research expenditure is written off as it is incurred. Development expenditure
is written off as it is incurred up to the point of technical and commercial
validation. Thereafter, costs that are measurable and attributable to the
project are carried forward as intangible assets, subject to having met the
following criteria:

 * demonstration that the product will generate profitable future economic
benefit and of an intention and ability to sell the product;

 * assessment of technical feasibility;

 * confirmation of the availability of technical, financial and other resources
to complete the development;

 * management intends to complete the development so the product will be
available for use; and

 * the expenditure attributable to the development can be reliably measured

Right-of-use assets (ROU)

At inception of a contract, the Group assesses whether a contract is, or
contains, a lease. A contract is, or contains, a lease if the contract conveys
the right to control the use of an identified asset for a period of time in
exchange for consideration. Leases are recognised as an ROU asset and a
corresponding lease liability at the date at which the leased asset is
available for use by the Group. At the lease commencement date, a ROU asset is
measured at cost comprising the following: the amount of the initial
measurement of the lease liability; any lease payments made at or before the
commencement date less any lease incentives received; any initial direct
costs; and restoration costs to return the asset to its original condition.
The ROU asset is depreciated over the shorter of the asset's useful life and
the lease term on a straight-line basis. If ownership of the ROU asset
transfers to the Group at the end of the lease term or the cost reflects the
exercise of a purchase option, depreciation is calculated using the estimated
useful life of the asset.

 

Foreign currencies

(a) Functional and presentation currency

Items included in the financial statements of each of the Group's entities are
measured using the currency of the primary economic environment in which the
entity operates ('the functional currency'). The consolidated financial
statements are presented in sterling which is the Group's presentation
currency.

 

(b) Transactions and balances

Foreign currency transactions are translated into the functional currency
using the exchange rates prevailing at the dates of the transactions. Foreign
exchange gains and losses resulting from the settlement of such transactions
and from the translation at year end exchange rates of monetary assets and
liabilities denominated in foreign currencies are recognised in the income
statement, except when deferred in equity as qualifying net investment hedges.
Non-monetary items carried at fair value and denominated in foreign currencies
are retranslated at the rates prevailing on the date when fair value is
determined.

 

3. Revenue and other income

Revenue is measured at the fair value of the consideration received or
receivable and net of discounts and sales-related taxes.

 

                                  31 December  31 December  30 June
                                  2025         2024         2025
                                  £'000        £'000        £'000

 Revenue from customer contracts  463          298          764
 Grant and other income           107          52           190
                                  570          350          954

 

4. Operating segments

                                                  Diagnostic Segment  Administrative  Total

                                                                      Costs
 Six months ended 31 December 2025                £'000               £'000           £'000
 Revenue and other income                         570                 -               570
 Costs                                            (2,333)             (856)           (3,189)
 Operating loss                                   (1,763)             (856)           (2,619)
 Finance income                                                                       3
 Loss on ordinary activities before taxation                                          (2,616)
 Taxation                                                                             175
 Loss for the financial period                                                        (2,441)

                                                  Diagnostic Segment  Administrative  Total

                                                                      Costs
 Six months ended 31 December 2024                £'000               £'000           £'000
 Revenue and other income                         350                 -               350
 Costs                                            (2,058)             (862)           (2,920)
 Operating loss                                   (1,708)             (862)           (2,570)
 Finance income                                                                       41
 Loss on ordinary activities before taxation                                          (2,529)
 Taxation                                                                             200
 Loss for the financial period                                                        (2,329)

                                                  Diagnostic Segment  Administrative  Total

                                                                      Costs
 Twelve months ended 30 June 2025                 £'000               £'000           £'000
 Revenue and other income                         954                 -               954
 Costs                                            (4,233)             (2,101)         (6,334)
 Operating 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 period                                                        (5,231)

 

5. Finance income and costs

 

                                   31 December  31 December  30 June
                                   2025         2024         2025
                                   £000         £000         £000
 Interest income on bank deposits  3            41           43

 

 

                                            31 December  31 December  30 June
                                            2025         2024         2025
                                            £000         £000         £000

 Transaction costs relating to share issue  -            -            (89)
 Finance costs                              -            -            (89)

 

6. Current tax asset

The current tax asset relates to the estimate of the refund under the R&D
tax credit scheme of £0.6m (H1 2024/5: £0.9m).  This includes £0.2m for
the interim period to December 2025 that would be received following
submission of the tax returns for the 12 months to June 2026, with receipt
expected to be in the first quarter of 2027.

7. Earnings per share

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 period.  The weighted average
number of shares in issue during the period was 836,326,732 (H1 2024/5:
543,141,481).  As the Company is loss-making, no potentially dilutive options
have been added into the EPS calculation. (H1 2024/5: no shares).

 

8. Share capital

 Allotted, issued and fully paid:                No              £000
 Balance at 30 June 2024 and 31 December 2024    543,141,481    8,147
 Share issue: April 2025                         81,753,927     1,226
 Balance at 30 June 2025                         624,895,408    9,373
 Share issue: September 2025                     400,000,000    60
 Share issue: October 2025                       4,708,584      1
 Balance at 31 December 2025                     1,029,603,992  9,434

 

9.  Other Reserves

                                      Share Premium Account  Shares to be issued  Employee Share Incentive Plan Reserve  Share Options Reserve  Reverse Acquisitions Reserve      Total

                                      £000                   £000                 £000                                   £000                   £000                              £000

 At 30 June 2024                      54,930                 720                  (196)                                  1,698                  (2,496)                                54,656
 Equity settled share-based payments  -                      -                    -                                      40                     -                                      40
 At 31 December 2024                  54,930                 720                  (196)                                  1,738                  (2,496)                                54,696
 Equity settled share-based payments  -                      -                    -                                      44                     -                                      44
 At 30 June 2025                      54,930                 720                  (196)                                  1,782                  (2,496)                                54,740
 Share issue: September 2025          480                    -                    -                                      -                      -                                      480
 Share issue: October 2025            9                      -                    -                                      -                      -                                      9
 Equity settled share-based payments  -                      -                    -                                      38                     -                                      38
 At 31 December 2025                  55,419                 720                  (196)                                  1,820                  (2,496)                                55,267

 

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