Medivir Ab · OMXSTO:MVIR
Medivir Ab — Investor Presentation (November 2025)
40 slides from Medivir Ab's investor presentation, November 2025
Slide 1: Improving life for advanced liver cancer (HCC) patients
Placeholder agenda Improving Improvinglife forfor life advanced advanced liver liver cancer (HCC) patients 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: Continued progress
Continued progress Placeholder agenda Right’s issue enables rapid generation of randomized, comparative data to confirm benefit of fostrox combination with Lenvima Design of planned phase 2 study strengthened by latest data in advanced HCC Remetinostat out-license generates significant potential val
Slide 3: Medivir enters exclusive licensing agreement with Biossil, Inc. for remetinostat
Medivir enters exclusive licensing agreement with Biossil, Inc. for remetinostat Positive phase 2 data in basal cell carcinoma (BCC) and cutaneous T-cell lymphoma (CTCL) Global, exclusive, licensing agreement to develop and commercialize remetinostat Total, potential milestone payments of approximat
Slide 4: Remetinostat is an effective topical treatment for reducing BCC disease burden
Remetinostat is an effective topical treatment for reducing BCC disease burden in a clinically significant manner >50% of lesions achieving complete Encouraging efficacy across all subtypes of BCC lesions pathological resolution across full cohort Nodular 0% -10% -20% 70% -30% Percentage change -40%
Slide 5: 45% of US adults are obese; more than 25% have Fatty Liver Disease
45% of US adults are obese Fatty Liver Disease increases More than 25% have Fatty Liver Disease risk of Liver Cancer 17-fold 5
Slide 6: Growth in Fatty Liver Disease expected to drive an alarming increase in liver cancer
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 7: Fostrox – designed to selectively kill tumor cells in the liver
Fostrox – designed to selectively kill tumor cells in the liver Prodrug transports inactive payload to the liver, where it is rapidly activated by liver enzymes1 Kills tumor cells2,3,4 Spares healthy cells2,3,4 Liver-guided Tumor-selective delivery – payload – prodrug troxacitabine 1Bethell, R. et a
Slide 8: 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 9: Medivir management team
Medivir management team CEO CMO CFO CSO Jens Lindberg Dr. Pia Baumann Magnus Christensen Fredrik Öberg • > 25 years of experience from • MD PhD with a specialist degree in • > 25 years of experience in finance. • PhD in Medical Science & Adjunct pharmaceutical industry with focus on medical & radiat
Slide 10: First-to-market opportunity in 2nd line HCC market valued >$2.5bn
First-to-market opportunity in 2nd line HCC market valued >$2.5bn Slide 10
Slide 11: Fostrox + Lenvima targets 2L population where no treatments are approved today
Fostrox + Lenvima targets 2L population where no treatments are approved today Advanced HCC – Treatment Algorithm 1L 90% 10% • Majority treated with IO combo • Tecentriq + Avastin preferred with recent data strengthening its position IO combination Lenvatinib (or Sorafenib) • Data presented at ASCO
Slide 12: 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 13: Absence of effective treatment options in 2nd line HCC
Absence of effective treatment options in 2nd line HCC Treatment algorithm – major Competitive landscape in 2nd line HCC highlights lack of novel mechanisms in need for new 2nd line options development with fostrox + Lenvima at the forefront 1st line treatment “We are becoming greedy, IO combinati
Slide 14: Fostrox – tailored for the specific needs of HCC
Fostrox – tailored for the specific needs of HCC Slide 14
Slide 15: Targeted treatment approach critical in liver cancer (HCC)
Targeted treatment approach critical in liver cancer (HCC) ~80% of patients have impaired liver function due to underlying liver disease1,2 Key objective – target cancer Tumor growth cells, minimize primarily occurs effects on healthy locally in the liver1 cells Critical to achieve selective targeti
Slide 16: Fostrox – tailored for HCC to achieve targeted DNA damage in liver tumor cells
Fostrox – tailored for HCC to achieve targeted DNA damage in liver tumor cells with minimal impact on healthy liver cells The same, proven & highly successful approach used in HCV to Combining prodrug & payload enables oral administration maximize liver-targeting2 & targeted (>100-fold) liver exposu
Slide 17: Fostrox MoA – targeted DNA damage in liver tumor cells
Fostrox MoA – tailored for HCC to achieve targeted DNA damage in liver tumor cells with minimal impact on healthy liver cells Inactive Prodrug cytotoxic Fostrox taken as oral tablet Prodrug transports inactive payload via first-pass metabolism to the liver1 Rapidly activated by liver enzymes Trapped
Slide 18: 100-fold higher liver targeting vs IV administration & selective DNA damage
100-fold higher liver targeting vs IV administration & selective DNA damage in tumor cells enabling highly targeted mechanism >100-fold higher liver targeting with Liver tumor cells divide significantly Fostrox induces DNA damage in tumor fostrox than iv troxacitabine in rats more often than non-tum
Slide 19: Fostrox + Lenvima shows promise of improved outcomes in 2L HCC
Fostrox + Lenvima shows promise of improved outcomes in 2L HCC Slide 19
Slide 20: Fostrox Clinical Development Program
Fostrox Clinical Development Program; monotherapy PoC established, focus on combination approach in 2L HCC Future – Phase 1a Mono Phase 1b Mono Phase 1b Combo Phase 2a Combo Phase 2b Combo Single patient Fostrox + lenvatinib Fostrox + lenvatinib 3+3 dose Fostrox + lenvatinib Intrapatient dose dose e
Slide 21: Fostrox + Lenvima phase 1b/2a study design
Fostrox + Lenvima phase 1b/2a study design Fostrox + LEN Treatment until PD Fostrox + LEN • Adv/inop HCC 30 mg RP2D – 30 mg (n=15) Primary Endpoint: • 2L/3L (n=3) Safety • ≥ 18 y • ECOG ≤ 1 Fostrox + LEN* Key Secondary • Child-Pugh A 20 mg Endpoints: ORR, DCR, (n=3) TTP/PFS Patients were enrolled at
Slide 22: Global phase 1b/2a study with fostrox + Lenvima positive, final data presented at EASL
Global phase 1b/2a study with fostrox + Lenvima (TKI) positive, final data presented at EASL in February Poster P02-13 presented by Dr. Jeff Evans, Glasgow, at UK EASL Liver Cancer Summit in February in Paris 3 centres Korea 6 centres Spain 6 centres Slide 22
Slide 23: Patient characteristics reflecting generous inclusion criteria
Patient characteristics reflecting generous inclusion criteria Patient characteristics1 N = 21 Mean age (range) 62 yrs (42 - 82) Gender, Female / Male (%) 24 / 76 ECOG Performance status 0/1 (%) 71 / 29 Child-Pugh A (%) 100 Viral/Non-viral (%) 76* / 24 Extra hepatic lesion(s) Y/N (%) 67 / 33 AFP ≥4
Slide 24: Best % change in target lesion
More than 75% of patients experiencing tumor shrinkage1 Best percentage change in target lesion size related to treatment response in first line 30% 20% Disease control on prior therapy Best % change in target lesion 16% Primary refractory on prior therapy 10% Median duration of response 7.0 11%
Slide 25: Median TTP 10.9 months, indicating substantially improved efficacy
Median TTP 10.9 months, indicating substantially improved efficacy compared with Lenvima alone1 Median time to progression (TTP) with fostrox + LEN – investigator review, RECISTv1.1 Fostrox + LEN (n =21)1 Median TTP, mo 10.9 95% CI (4.1 – 18.1) ORR 24% • Median time to progression 10.9 months DCR 81
Slide 26: Median TTP 10.9 months, longer than Lenvima monotherapy and other 2L HCC treatments
Median time to progression (TTP) 10.9 months, remarkably longer than Lenvima monotherapy and other 2L HCC treatments Median TTP (Kaplan-Meier) with fostrox + Lenvima Median TTP/PFS vs previous studies in 2L HCC ~3.5-4 months Lenvima after IO combo: Fostrox + LEN (n =21)1 Kobayashi et al. 2023 (n=12)
Slide 27: Korean Cancer Study Group prospective data with Lenvima post Tecentriq + Avastin
Korean Cancer Study Group prospective study data with Lenvima post Tecentriq + Avastin, aligns with other 2nd line outcome data Slide 1Kim et al., Journal of Hepatology, Sept 04 2025
Slide 28: Similar patient characteristics across Lenvima monotherapy and fostrox + Lenvima studies
Similar patient characteristics across the Lenvima monotherapy study and the Phase 1b/2a fostrox + Lenvima study N = 50 N = 21 Patient characteristics Lenvima monotherapy Fostrox + Lenvima 13 sites in Korea1 15 sites in Korea, UK & Spain2 Mean age (range) 66 (32-86) 62 yrs (42 - 82) Gender, Female
Slide 29: Fostrox + Lenvima showed better outcomes compared to Lenvima monotherapy
Fostrox + Lenvima phase 1b/2a data showed substantially better outcome data compared to the Lenvima montherapy study Median TTP – Fostrox + Lenvima1 Median PFS – Lenvima monotherapy2 Fostrox + Lenvima (n=21)1 Lenvima (n=50)2 Median TTP, mo 10.9 Median PFS, mo 5.4 95% CI (4.1 – 18.1) 95% CI (4.2 – 7.
Slide 30: Fostrox + Lenvima shows encouraging tolerability
Fostrox + Lenvima shows encouraging tolerability enabling patients to remain on treatment long-term Slide 30
Slide 31: Absolute neutrophil and platelet counts stable over course of treatment
Absolute neutrophile and platelet counts were stable over the course of treatment, enabling long-term use1 Longitudinal neutrophil & platelet counts, at all time points measured over first 10 months of treatment 8 000 Neutrophils Platelets 350 000 7 000 300 000 6 000 250 000 neutrophils per microlit
Slide 32: Liver targeting properties supports encouraging tolerability profile
Liver targeting properties supports encouraging tolerability profile, enabling patients to remain on treatment long-term Treatment Treatment Fostrox LEN emergent AEs emergent AEs Treatment- Treatment- Adverse Events* any grade Grade ≥ 3 related Grade ≥ 3 related Grade ≥ 3 No of pts (%) No of pts (%)
Slide 33: Stable liver function during treatment with fostrox + Lenvima
Stable liver function during treatment with fostrox + Lenvima – no deterioration in liver enzymes or change in ALBI score ALT change over duration of AST change over duration of ALBI score change over duration of treatment treatment treatment 200 -1,50 ALBI Score 80 -2,00 150 60 -2,50 AST (U/L) ALT
Slide 34: FLEX-HCC: Phase 2 study to confirm benefit of fostrox combination with Lenvima
FLEX-HXX: Phase 2 study enables rapid generation of randomized, comparative data to confirm benefit of fostrox combination with Lenvima in 2nd line HCC Slide 34
Slide 35: FLEX-HCC: Fostrox + Lenvatinib Combination for Advanced HCC
FLEX-HCC Fostrox + Lenvatinib Combination for Advanced HCC Primary Investigator Korea 8 centres Dr. Hong Jae Chon CHA Bundang Hospital, Seoul, Korea 35 Slide 35
Slide 36: FLEX-HCC: Randomized, comparative phase 2 study design
FLEX-HCC: Randomized, comparative phase 2 study to confirm benefit for fostrox + Lenvima combination in 2nd line HCC 2026 2027 Study design: • 80 pts randomized: Fostrox + Lenvima vs Inclusion criteria Fostrox 30 mg + Primary endpoint: Lenvima Lenvima SD* • ORR (BICR) • 8 sites in Korean Cancer Stud
Slide 37: Key patent approval in Japan for fostrox + Lenvima extending protection until 2041
Key patent approval in Japan for fostrox + Lenvima extending protection until 2041, complementing previous approval in EU Covers the combination of fostrox + Lenvima for the treatment of HCC and metastases to the liver Now approved in Japan, EU and Australia which indicates likelihood of other key r
Slide 38: 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 39: Board with extensive drug development experience
Board with extensive drug development experience Chairman of the Board Board member Board member Dr. Uli Hacksell Dr. Angelica Loskog Dr. Anna Törner Member since 2018, Chairman Ph D, Clin. Immunology Ph D Statistics, MScs Pharmacy since 2021 CEO Lokon Pharma & scientific Broad experience
Slide 40: Thank You!
Thank You! Slide 40