Slide 1: Medivir Q2 Report 2024
MEDIVIR Q2 REPORT 2024
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: Placeholder agenda
Placeholder agenda Superior efficacy with Fostrox + Lenvima® at ESMO GI Confirmation of liver targeting without negative impact on normal liver function Acceleration of fostrox development according to plan 3 Slide
Slide 4: Today's presenters
Today’s presenters CEO CMO CFO CSO Jens Lindberg Pia Baumann Magnus Christensen Fredrik Öberg Slide 4
Slide 5: Continued acceleration of fostrox development, strengthened by median TTP of 10.8 months
Continued acceleration of fostrox development, strengthened by estimated median time to progression (TTP) of 10.8 months Slide 5
Slide 6: A liver cancer epidemic in the making, driven by fatty liver disease
A liver cancer epidemic in the making, driven by fatty liver disease, caused by obesity, alcohol och viral infections Fastest growing cancer in the USA Liver Fatty Liver Disease is the fastest Cancer growing cause of HCC >25% of US adults have Fatty Liver Fatty Liver Disease Disease >90% of
Slide 7: Global phase 1b/2a study with fostrox + Lenvima (TKI)
Global phase 1b/2a study with fostrox + Lenvima (TKI) UK 3 centres Key study features Korea Fostrox + Lenvima in advanced HCC with 6 centres generous inclusion criteria, including 2L & 3L patients Spain Detailed and mature clinical data to be 5 centres presented at ESMO, September 16, in Barcelo
Slide 8: Fostrox + Lenvima poster presentation at ESMO GI in June
Fostrox + Lenvima poster presentation at ESMO GI in June Patient demographics & disease characteristics N = 21 Mean age (range) 62 yrs (42 - 82) Gender, Female / Male (%) 24 / 76 Chon et al., ESMO GI 2024, Poster 176 ECOG Performance status 0/1 (%) 71 / 29 Child-Pugh A (%) 100 Viral/Non-viral (%) 76
Slide 9: Fostrox – liver targeted inhibitor of DNA replication
Fostrox – liver targeted inhibitor of DNA replication Active substance Prodrug Oral administration & targeted (>100- troxacitabine fold) liver exposure vs IV chemotherapy1 Molecule stable in GI tract & in blood, rapidly activated by enzymes in the liver2 Same approach as in HCV Causes DNA damage in
Slide 10: Liver pharmacodynamics confirm fostrox tumor selectivity
Liver pharmacodynamics confirm fostrox tumor selectivity1 Paired biopsies showing increased DNA-damage in proliferative Tumor selective DNA-damage observed in liver biopsies from regions, and increased hypoxia after treatment patients on fostrox + Lenvima X DNA-damage 4 0 GLUT1/ H&E pH2AX pH2AX Ki67
Slide 11: Liver function was stable during treatment with fostrox + Lenvima
Liver function was stable during treatment with fostrox + Lenvima – no deterioration in liver enzymes or change in ALBI score1 ALT change over duration of AST change over duration of ALBI score change over duration of treatment treatment treatment 200 -1,50 80 -2,00 ALBI Score 150 60 -2,50 AST (U/L)
Slide 12: Median time to progression 10.8 months, longer than Lenvima monotherapy
Median time to progression (TTP) 10.8 months, noticeably longer than Lenvima monotherapy or other 2L HCC treatments1 Median TTP (Kaplan-Meier) with fostrox + Lenvima 1.0 Fostrox + Lenvima (n =21)1 0.8 Median TTP, mo 95% CI 10.8 (4.1 – NE) Estimated median time to progression 10.8 months at ESMO GI
Slide 13: Median time to progression 10.8 months vs other 2L HCC treatments
Median time to progression (TTP) 10.8 months, noticeably longer than Lenvima monotherapy or other 2L HCC treatments Median TTP (Kaplan-Meier) with fostrox + Lenvima Median TTP/PFS vs previous studies in 2L HCC 2,8 – 6,1 Lenvima after IO combo: 1.0 Fostrox + Lenvima (n =21)1 Kobayashi et al. 2023 (n=
Slide 14: KOL insights on website from latest fostrox data at ESMO GI
KOL insights on website from latest fostrox data at ESMO GI with poster presentation and webcast at ESMO in September Video interview from ESMO GI available on Medivir website Poster presentation with mature safety and efficacy data highlighting the clinical value of the combination in second line
Slide 15: Next step: randomized phase 2b with dose optimization run-in
Next step: randomized phase 2b with dose optimization run-in Fostrox dose A + Primary Endpoint: Lenvima • ORR Fostrox dose A or B + Lenvima Secondary Advanced HCC Endpoints: Fostrox dose B + post one prior 1:1:1 • PFS Lenvima IO treatment 1:1 • DoR • DCR • Safety • QoL Placebo + Lenvima Placebo + Le
Slide 16: Fostrox – well under way preparing for phase 2b
Fostrox – well under way preparing for phase 2b H2 ‘23 H1 ‘24 H2 ‘24 H1 ‘25 ‘ CMC formulation Drug Substance & Drug Product manufacture for phase 2b development KOL engagement ahead CRO Study of FDA interactions selection feasibility FDA engagement to Select PI, finalize National approvals of confir
Slide 17: Second line HCC market valued >USD 2.5 billion by 2030
Second line HCC market valued >USD 2.5 billion by 2030 Large unmet need in fast growing population Market potential > USD 2.5bn by 2030 & growing3 3rd Avg monthly price leading cause of cancer death worldwide1 ~4.300 USD (3–10.000) Patients Average +122% receiving 2L therapy treatment duration HCC e
Slide 18: Fostrox – potential to improve second line HCC therapy
Fostrox – potential to improve second line HCC therapy Unique, targeted mechanism Unprecedented benefit First-to-market opportunity 10.8 >$2.5bn selectively killing cancer months until tumor market in patients with no cells in the liver progression approved treatments Slide 18
Slide 19: Financial highlights Q2
Financial highlights Q2 Slide 19
Slide 20: Financial summary Q2, 2024
Financial summary Q2, 2024 Consolidated Income Statement, summary Q2 Q1 - Q2 Full year (SEK m) 2024 2023 2024 2023 2023 Net turnover 1.1 2.0 1.6 2.4 7.6 Other operating income 0.1 0.6 0.3 1.0 1.4 Total income 1.2 2.6 1.9 3.3 9.0 Other external expenses -30.3 -21.2 -51.0 -34.3 -68.9 Personnel costs -
Slide 21: Fostrox – potential to improve second line HCC therapy
Fostrox – potential to improve second line HCC therapy Unique, targeted mechanism Unprecedented benefit First-to-market opportunity 10.8 >$2.5bn selectively killing cancer months until tumor market in patients with no cells in the liver progression approved treatments Slide 21
Slide 22: Q/A
Q/A Slide 22
Slide 23: Fostrox – potential to improve second line HCC therapy
Fostrox – potential to improve second line HCC therapy Unique, targeted mechanism Unprecedented benefit First-to-market opportunity 10.8 >$2.5bn selectively killing cancer months until tumor market in patients with no cells in the liver progression approved treatments Slide 23
Slide 24: Thank You!
Thank You! Slide 24