Medivir Ab · OMXSTO:MVIR
Medivir Ab — Q4 2024 Earnings Presentation
22 slides from Medivir Ab's earnings presentation, Feb 18, 2025
Slide 1: Medivir Q4 Report 2024
Placeholder agenda Medivir Improving Q4 REPORT life for 2024 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: Continued momentum in Q4
Continued momentum in Q4 Placeholder agenda Phase 1b/2a study closed & final data to be presented at EASL Liver Cancer Summit, February 20 IND approval for phase 2b study Ramping up collaboration with Eisai & progressing plans outside USA 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 phase 2b study initiation in progress with prospective ESMO Asia data
Continued phase 2b study initiation in progress with prospective ESMO Asia data confirming fostrox + Lenvima® clinical benefit Slide 5
Slide 6: IND approval obtained for randomized FOcuS-2 study of fostrox + Lenvima vs Lenvima
IND approval obtained for randomized FOcuS-2 study of fostrox + Lenvima vs Lenvima Study design with dose run in to select optimal dose, aligned with FDA Project Optimus ORR selected as primary endpoint, a surrogate endpoint accepted for accelerated approvals in HCC Statistically powered to show a c
Slide 7: FOcuS-2 IND approved; design optimized for potential breakthrough designation
FOcuS-2 IND approved; design optimized for potential breakthrough therapy designation & accelerated approval filing 2025 2026 2027 2028 Part 1 Dose selection for Part 2 Part 2 Inclusion criteria Fostrox 30 mg + Fostrox xx mg + Primary endpoint: • Advanced HCC Lenvima DSMB: Lenvima • ORR • One prior
Slide 8: Focus-2: Global, randomised phase 2b at 40 sites in 8 countries
Focus-2: Global, randomised phase 2b at 40 sites in 8 countries across 3 regions to maximise speed and clinical relevance Slide
Slide 9: Focus-2: Post IND approval – progress in study start-up activities
Focus-2: Post IND approval – progress in study start-up activities Key preparation • Site selection finalisation & initiation of contracts • Country regulatory and ethic committee submissions activities for • Study set-up collaboration with Eisai, including Lenvima supply • Supply of study drugs rea
Slide 10: ESMO Asia 2024 – First prospective 2nd line study in advanced HCC
ESMO Asia 2024 – First prospective 2nd line study in advanced HCC evaluating Lenvima monotherapy post Tecentriq + Avastin Slide 10
Slide 11: Similar patient characteristics across studies
Similar patient characteristics across studies N = 211 N = 502 Patient characteristics Fostrox + Lenvima Lenvima monotherapy 15 sites in Korea, UK & Spain 13 sites in Korea Mean age (range) 62 yrs (42 - 82) 66 (32-86) Gender, Female / Male (%) 24 / 76 18 / 82 Child-Pugh A (%) 100 100 BCLC stage A/B
Slide 12: ESMO Asia 2024 – 2nd line prospective Lenvima monotherapy data
ESMO Asia 2024 – 2nd line prospective Lenvima monotherapy data post Tecentriq + Avastin, confirms previous outcome data Median PFS (investigator assessed RECIST 1.1) Median PFS confirming previously reported outcome data for Lenvima as monotherapy in advanced HCC post an IO combination OS 8.6 mo
Slide 13: Fostrox + Lenvima phase 1b/2a data showed substantially longer PFS/TTP
Fostrox + Lenvima phase 1b/2a data showed substantially longer PFS/TTP compared to prospective study of Lenvima alone Median PFS – Lenvima monotherapy2 Median TTP – Fostrox + Lenvima1 Median PFS: Median TTP: 5.4 months (95% CI, 5.3 – 5.6) 10.9 months (95% CI, 4.1 – 18.1) At risk – All pts 21 16 14 1
Slide 14: Final phase 1b/2a data to be presented at EASL Liver Cancer Summit
Final phase 1b/2a data to be presented at EASL Liver Cancer Summit on Thursday February 20th Poster P02-13: Final safety and efficacy results from the phase 1b/2a study of fostrox plus lenvatinib in second/third line advanced hepatocellular carcinoma progressed on immunotherapy T.R. Jeffry Evans1, H
Slide 15: Lack of effective treatment options in 2nd line HCC
Lack of effective treatment options in 2nd line HCC with absence of 2nd line data at ASCO GI and EASL 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 tr
Slide 16: 45% of US adults are obese; Fatty Liver Disease increases risk of Liver Cancer
45% of US adults are obese Fatty Liver Disease increases More than 25% have Fatty Liver Disease risk of Liver Cancer 17-fold 16
Slide 17: 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 18: Financial highlights Q4
Financial highlights Q4 Slide 18
Slide 19: Financial summary Q4, 2024
Financial summary Q4, 2024 Consolidated Income Statement, summary Q4 Q1 - Q4 (SEK m) 2024 2023 2024 2023 Net turnover 1.0 4.4 3.5 7.6 Other operating income 0.4 0.2 1.0 1.4 Total income 1.4 4.7 4.5 9.0 Other external expenses -20.6 -16.5 -101.3 -68.9 Personnel costs -6.8 -7.9 -27.2 -27.4 Depreciatio
Slide 20: Q/A
Q/A Slide 20
Slide 21: 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 22: Thank You!
Thank You! Slide 22