Placeholder agenda

Improving life for advanced liver cancer (HCC) patients

Displacing chemotherapy with the first oral, liver-activated inhibitor of DNA replication

Medivir Q3 REPORT 2025

Fostrox - The first oral, liver-targeted treatment for advanced HCC



Q3 Highlights

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 value upside

Placeholder agenda

3

Slide



Today's presenters



CEO

Jens Lindberg

CMO

Pia Baumann

CFO

Magnus Christensen

CSO

Fredrik Öberg



Slide 4



Phase 2 study enables rapid generation of randomized, comparative data to confirm benefit of fostrox combination with Lenvima

Slide 5



Latest data in HCC presented at ESMO highlights continued significant unmet medical need in second-line



  • Absence of second line data in liver cancer

  • High unmet medical need without any real new options

    • Potential promising options (CAR-T, ADC etc) in other tumour types is so far not applicable in HCC

  • Continued high interest in fostrox post immunotherapy among investigators



  • Latest data reinforces immunotherapy in 1st line HCC

    ESMO 2025: Tecentriq/Avastin entrenched as 1st line SOC in HCC



    • Global, randomized Phase 3 in 1st line advanced HCC (IMbrave152/SKYSCRAPER-14) with TIGIT + Tecentriq + Avastin vs Tecentriq + Avastin

    • 669 pats randomized 1:1





    • PFS curves superimposed - no difference in PFS

Recently announced data in earlier stage HCC strengthens the positioning of fostrox + Lenvima in 2nd line advanced HCC

ESMO 2024: Positive PFS with Keytruda + Lenvima + TACE vs TACE in intermediate stage HCC (LEAP-012)1

Oct 2025: No OS benefit with addition of Keytruda + Lenvima to TACE (LEAP-012)2



1Llovet et al, ESMO 2024, Presidential session

2Merck & Eisai press release on October 29, 2025

Slide 8

  • KEYTRUDA plus LENVIMA in addition to TACE did not provide significant OS benefit, one of the study's primary endpoints

  • As a result, the study will be closed

  • The results from LEAP-012 further reinforces immunotherapy combinations to be used in 1st line advanced stages of HCC

  • The outcome also strengthens the strategic positioning of fostrox + Lenvima in 2nd line HCC



    Randomized, comparative phase 2 study to strengthen evidence for fostrox + Lenvima combination in 2nd line HCC

    Inclusion criteria

    • 2L advanced HCC

    • One prior IO regimen

    • Child-Pugh A

    • ECOG PS 0-1

    Fostrox 30 mg + Lenvima SD* N=40

    1:1

    Lenvima SD* N=40

    *standard weight based dose in HCC

    Response assessments every 6 week with CT or MRI

    Study design:

    Primary endpoint:

    • ORR (BICR)

      Secondary endpoints:

    • DoR

    • PFS

    • OS

    • Safety

    2026

    2027

    • 80 pts randomized: Fostrox + Lenvima vs Lenvima

    • 8 sites in Korean Cancer Study Group

    • Enrolment: 12 months

    • Primary endpoint FU: 3-6 months

    • Efficacy evaluated by Blinded Independent Central Review (BICR)

      Key benefits:

    • Generates robust comparative efficacy and safety data in collaboration with established research consortium

    • Enables rapid data read out

    • Strengthens design of registrational study

Slide 9



Korean Cancer Study Group prospective study data with Lenvima post Tecentriq + Avastin, aligns with other 2nd line outcome data



1Kim et al., Journal of Hepatology, Sept 04 2025

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Medivir AB published this content on November 06, 2025, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on November 06, 2025 at 14:01 UTC.