Slide 1: Medivir Q1 Report 2025
Placeholder agenda Medivir Improving Q1 REPORT life for 2025 advanced liver cancer (HCC) patients Fostrox – Displacing The first oral, chemotherapy liver-targeted with the treatment first oral, liver-activated forofadvanced inhibitor HCC DNA replication
Slide 2: Important notice
Important notice You must read the following before continuing. The following applies to this document and the information provided in this presentation by Medivir AB (publ) (the “Company”) or any person on behalf of the Company and any other material distributed or statements made in connection wit
Slide 3: Q1 Highlights
Q1 Highlights Placeholder agenda Final phase 1b/2a data presented at EASL Liver Cancer Summit European patent for fostrox + lenvatinib approved, providing protection until 2041 as preparations for phase 2b study FOcuS- 2 continues Infex Therapeutics signs licensing agreement for MET-X development in
Slide 4: Today's presenters
Today’s presenters CEO CMO CFO CSO Jens Lindberg Pia Baumann Magnus Christensen Fredrik Öberg Slide 4
Slide 5: Final results from phase 1b/2a study of fostrox + Lenvima presented at EASL Liver Cancer Summit
Final results from phase 1b/2a study of fostrox + Lenvima® presented at EASL Liver Cancer Summit Slide 5
Slide 6: Global phase 1b/2a study with fostrox + Lenvima
Global phase 1b/2a study with fostrox + Lenvima Fostrox + LEN Fostrox + LEN Treatment until PD • Adv/inop HCC 30 mg RP2D – 30 mg (n=3) (n=15) Primary Endpoint: • 2L/3L • ≥ 18 y Safety • ECOG ≤ 1 Key Secondary Fostrox + LEN • Child-Pugh A Endpoints: ORR, 20 mg DCR, TTP, OS (n=3) Patients were enrolle
Slide 7: Fostrox + Lenvima shows longer median TTP and OS than previously seen in second-line HCC
Fostrox + Lenvima shows longer median TTP and OS than previously seen in second-line HCC1 Median TTP & OS with fostrox + LEN – investigator review, RECISTv1.1 Median TTP, mo 10.9 (95% CI, 4.2-18.1) Median OS, mo 13.7 (95% CI, 7.6 - NA) BOR, % 24 Median DoR, mo 7.0 (95% CI, 1.6-NR) DCR, % 81 At risk
Slide 8: Target lesion tumor reduction seen in >75% of patients
Target lesion tumor reduction was seen in >75% of patients and median duration of clinical benefit was 11.3 months Percentage change in total target lesion size over time – investigator review, RECISTv1.1 50% 40% 30% 20% 10% 0% -10% Patient still on treatment -20% -30% -40% -50% w2 w4 w6 w8 Screenin
Slide 9: Fostrox dose reduction didn't impact response to treatment
Fostrox dose reduction, required in 29% of patients, didn’t impact response to treatment Best % change in target lesion size related to fostrox dose reduction – investigator review, RECISTv1.1 30% No fostrox dose reduction 20% Fostrox dose reduction 10% 16% 11% 2% 1% 0% 0% -2% -7% -7% -10% -14% -14%
Slide 10: Key patent approval in Europe for fostrox + Lenvima extending protection until 2041
Key patent approval in Europe for fostrox + Lenvima extending protection until 2041 Covers the combination of fostrox + Lenvima for the treatment of HCC and metastases to the liver European patent authority approval indicates likelihood of other key regions to follow Generates critical extension of
Slide 11: Growth in Fatty Liver Disease expected to drive an alarming increase in liver cancer cases
Growth in Fatty Liver Disease expected to drive an alarming increase in liver cancer cases1 Fatty Liver Disease (MASLD/MASH) expected to rise dramatically over the next 30 years The number of newly diagnosed liver cancer patients each year is expected to double HCC market growth further spurred by m
Slide 12: Growth in Fatty Liver Disease expected to drive an alarming increase in liver cancer cases
Growth in Fatty Liver Disease expected to drive an alarming increase in liver cancer cases1 Slide 12 1JAMA Network Open. 2025;8(1):e2454707
Slide 13: 2nd line HCC – a large and growing commercial opportunity
2nd line HCC – a large and growing commercial opportunity with significant need for new treatment options3 $4.0 bn Growth driven by: HCC to increase +122% in the US and +82% in China2 by 2030, caused by fatty liver disease +115% $2.8 bn With improved 1L treatment, more patients will be fit enoug
Slide 14: Infex Therapeutics signs licensing agreement for MET-X development in India
Infex Therapeutics signs licensing agreement for MET-X development in India • Venus Remedies to conduct phase I trial for MET-X with healthy volunteers in India followed by phase II/III trial of MET-X, subject to successful phase 1 • Infex to receive upfront license fee payments, near-term milestone
Slide 15: Financial highlights Q1
Financial highlights Q1 Slide 15
Slide 16: Financial summary Q1, 2025
Financial summary Q1, 2025 Consolidated Income Statement, summary Q1 Full year (SEK m) 2025 2024 2024 Net turnover 0.6 0.5 3.5 Other operating income 0.2 0.1 1.0 Total income 0.8 0.6 4.5 Other external expenses -6.1 -20.7 -101.3 Personnel costs -7.0 -6.5 -27.2 Depreciations and write-downs -0.7 -0.7
Slide 17: Q/A
Q/A Slide 17
Slide 18: Fostrox: The first oral, liver-targeted treatment tailored for HCC
Fostrox (fostroxacitabine bralpamide) The first oral, liver-targeted treatment tailored for HCC Oral, liver-activated small molecule inducing DNA 10.9 months time to progression, damage in tumor cells, sparing healthy liver cells3 substantially better than SoC1,2 12 Unique, liver-targeted No DNA dam
Slide 19: Thank You!
Thank You! Slide 19