Slide 1: Advancing Rapid Pharmacogenetic testing to the point-of-care
Advancing Rapid Pharmacogenetic testing to the point-of-care Dr Gino Miele, CEO Year End Results: 30 June 2025 genedrive plc (LSE: GDR) 8th December 2025 Russ Shaw, CFO Transforming Patient Outcomes
Slide 2: Executive Leadership
Executive Leadership. Dr Gino Miele | Chief Executive Officer & CSO • Appointed CEO August 2024 (CSO/R&D Director since 2015). • Track record of translating molecular diagnostic R&D innovations into clinical products. • Key driver of genedrive's market-leading position into rapid pharmacogenetics in
Slide 3: Agenda
Agenda. • Unmet clinical need, products & positioning. • FY25 highlights & progress. • FY25 Financials. • Outlook. Rapid PGx - Transforming Patient Outcomes
Slide 4: Genedrive “at a glance”
Genedrive “at a glance”. • Genedrive provides rapid pharmacogenetic testing solutions for emergency healthcare settings. • Two CE-IVD certified products addressing unmet clinical needs in neonatology, neurology and cardiology; (1) for avoidance of antibiotic induced hearing loss in neonates & (2) fo
Slide 5: Unmet Clinical Need
Unmet Clinical Need. THE CLINICAL PROBLEM Common medicines are ineffective in a lot of people Individual DNA variation influences drug Huge prescription cost burden response (Pharmacogenetics; “PGx”) (£20Bn NHSE spend in 2023/24) Leads to inneffective medicines Antidepressants (£224M) (poor/no respo
Slide 6: Unmet Clinical Need
Unmet Clinical Need. SOLUTION “Genotype-guided prescription” • the right drug at the right dose for the right patient at the right time. 95% of individuals have at least one DNA analysis from patient samples for PGx actionable PGx variant for a common are typically processed in central diagnostic me
Slide 7: Unmet Clinical Need
Unmet Clinical Need. SOLUTION “Genedrive’s Near-Patient Rapid Genetic Testing” • Rapid, actionable PGx in time-critical clinical situations. Inexpensive, rapid thermocycler. Room-temperature stable assays Rapid, laboratory quality PGx results in Designed with the NHS, for the NHS No cold-chain requi
Slide 8: Antibiotic Induced Hearing Loss
Antibiotic Induced Hearing Loss. Neonatal Emergency Care PGx 1 in 7 babies born in UK are admitted to NICU Worlds’-first rapid PGx in NICU emergency care annually (~100,000) Interventional PGx enabling clinician to assess Significant proportion require treatment with safety of aminoglycoside adminis
Slide 9: Clopidogrel “resistance”
Clopidogrel “resistance”. Stroke & Cardiovascular PGx 100K strokes/year in UK (12M globally) 1 every 3 seconds. 1 in 4 people globally in their lifetime Targets five CYP2C19 Loss-of-Function 2nd leading cause of death. 94 million people living with alleles. effects of stroke (global cost of $890Bn p
Slide 10: Scientific & Clinical Drivers
Scientific & Clinical Drivers. National & international clinical guidance, recommendations & positive health economics Rapid PGx - Transforming Patient Outcomes
Slide 11: Scientific & Clinical Drivers
Scientific & Clinical Drivers. National & international clinical guidance, recommendations & positive health economics • “Any patient who is about to be prescribed clopidogrel, regardless of the underlying indication” • Some patients already on clopidogrel may either have another atherothrombotic ev
Slide 12: Healthcare political Drivers
Healthcare political Drivers. UK Healthcare & Political drivers underpinning product positioning NHSE 10 year health plan Preventing Ill Health: Prioritise health prevention over treatment. Expansion of NICE’s Technology “Genomics” highlighted as Appraisal pathway (mandating NHS “transformative tech
Slide 13: Commercial Drivers & Market Opportunity
Commercial Drivers & Market Opportunity. Clinical unmet needs with global relevance UK (£26M) £9M (MT-RNR1) First-to-market* / Best in class £17M(CYP2C19) High-margin, recurring revenue model (post-implementation) Substantial productivity gains, cost Direct savings & patient outcomes • Total address
Slide 14: Progress: Genedrive MT-RNR1
Progress. Genedrive® MT-RNR1 • 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 4 UK nations, and in smaller NICU Tier settings. In routine use at 1
Slide 15: Progress: Genedrive MT-RNR1
Progress. Genedrive® MT-RNR1 • MOU with the Kingdom of Saudi Arabia’s Ministry of Health (MOH) to introduce the test under the “Generations Hear” program, leading to potential national implementation under a national initiative "Generations Hear”. • Following Breakthrough Device Designation (BDD) fr
Slide 16: Progress: Genedrive CYP2C19
Progress. 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® CYP2C1
Slide 17: Progress: Genedrive CYP2C19
Progress. Genedrive® CYP2C19 • Positive value assessment by Scotland’s Scottish Health Technology group (SHTG), leading to Scottish Government investment to support national testing of CYP2C19 in Stroke patients – with Genedrive included in CYP2C19 genotyping pilot in rural areas for Transient Ischa
Slide 18: FY25 Financials
FY25 Financials. FY25: Average headcount (FTE) = 43 Admin Executive Directors, Admin, Finance, HR & IT Engineering User led system refinements, integration and field support Scientific Product development & on-market support QARA Regulatory and compliance: CE-IVD, ISO 13485 and in-country registrati
Slide 19: FY25 Financials: Income statement
FY25 Financials. Income statement H1 H2 FY25 FY24 £'000 £'000 £'000 £'000 Revenue from customer contracts 298 466 764 332 RNR1 in routine use and first commercial sale of CYP2C19 Grant and other income 52 138 190 169 DEVOTE Grant income for CYP2C19 Revenue and other income 350 604 954 501 Diagnostic
Slide 20: FY25 Cash Flow
FY 25 Cash Flow. Cash Flow H1 H2 FY25 FY24 £'000 £'000 £'000 £'000 Operating loss before changes in working capital (2,487) (2,742) (5,229) (5,006) Similar levels to FY24 Working capital (611) 222 (389) 407 Working capital increased by £0.4m – mainly due to creditors Taxation - 474 474 831 HMRC R&D
Slide 21: Summary & Outlook
Summary & Outlook. • Genedrive are well positioned to capitalise on the emerging paradigm of near-patient pharmacogenetic testing • Two world-leading genetic tests for use in near-patient, time critical emergency care settings; With clear global unmet clinical need & recommended by NICE Underpin
Slide 22: Newsflow – what to expect
Newsflow – what to expect. Through FY • £1M shareholder loan • Longer term financing • Scotland MT-RNR1 implementation progress • Scotland CYP2C19 progress • Commercial progress for both products domestically & internationally. • US FDA 510(k) submission progress for CYP2C19 • US FDA de novo submiss
Slide 23: Q&A
Q&A genedrive