Slides
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Improving life for advanced liver cancer (HCC) patients Displacing chemotherapy with the first oral, liver - activated inhibitor of DNA replication Placeholder agenda Medivir Q2 REPORT 2025 Fostrox – The first oral, liver - targeted treatment for advanced HCC
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Slide Important notice 2 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 with such presentation (the “Information”), and you are therefore advised to carefully read the statements below before reading, accessing or making any other use of the Information. In accessing the Information, you agree to be bound by the following terms and conditions. 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Slide Placeholder agenda 3 ASCO & ESMO-GI data presentations confirm fostrox frontrunner position in 2L HCC Japan patent for fostrox + lenvatinib approved, providing protection until 2041, complementing previous approvals in EU and Australia Concentra acquiring IGM Biosciences, birinapant returned to Medivir Q2 Highlights
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Slide CEO Jens Lindberg Today’s presenters CMO Pia Baumann CFO Magnus Christensen CSO Fredrik Öberg 4
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Slide 5 ASCO & ESMO-GI data presentations confirm fostrox frontrunner position in 2L HCC
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Slide ASCO and ESMO-GI presentations confirm gap in clinical data and lack of consensus in 2nd line advanced HCC 6 1st line2nd & 3rd line
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Slide 77 • 22 patients with progression on prior treatment enrolled at 7 sites in Germany • Treated with cabozantinib 60 mg once daily Median PFS: 2.96 months (95% CI, 2.27 – 9.17)
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Slide 88 • 230 HCC patients on 2L treatment post atezolizumab + bevacizumab; lenvatinib (n=125) or sorafenib (n=105) • Study confirmed lenvatinib superiority over sorafenib and similar efficacy for lenvatinib monotherapy as in previous studies: • Median PFS of 5.5 months • Disease Control Rate of 57.7%
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Slide Recent review of HCC studies in 2nd line confirms unmet need with an ORR < 10% and a PFS of around 4 months 9 TKIs (lenvatinib, sorafenib etc) Mean results across 8 studies Fostrox + lenvatinib ORR 7.7% 24% DCR 65.6% 81.0% PFS/TTP 3.4 months 10.9 months Chan et al., “Treatment for hepatocellular carcinoma after immunotherapy” Annals of Hepatology, February 2025
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Slide 0 5 10 15 TTP - Months Treatment outcome substantially improved with Fostrox + Lenvima compared to Lenvima monotherapy and other 2L HCC treatments 1010 Median TTP (Kaplan-Meier) with fostrox + Lenvima Median TTP/PFS vs previous studies in 2L HCC Lenvima after IO combo: Kobayashi et al. 2023 (n=12) Chon et al. 2024 (n=40) Hiraoka et al. 2023 (n=101) Palmer et al. 2023 (n=53) Yoo et al. 2023 (n=19) Yano et al. 2023 (n=24) Persano et al. 2024 (n=86) Other TKIs in 2L: Abou-Alfa et al. 2018 (n=470) Chan et al. 2022 (n=48) Bruix et al. 2016 (n=379) Yoo et al. 2024 (n=40) Zhu et al. 2019 (n=292) Pembro + regorafenib in 2L: El-Khoueiry et al. 2024 (n=68) Fostrox + Lenvima (n=21) 1Chon et al., ESMO 2024, Poster 986. At risk – All pts 21 16 14 10 9 7 3 2 2 2 1 0 ~3.5-4 months Fostrox + LEN (n =21)1 Median TTP, mo 95% CI 10.9 (4.1 – 18.1) ORR 24% DCR 81%
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Slide 11 • To compare the HR-QoL effects associated with different first-line treatments for unresectable or advanced HCC • To integrate treatment-induced survival benefit with impact on patients’ HR-QoL. OBJECTIVE CONCLUSIONS AND RELEVANCERESULTS • Atezolizumab plus bevacizumab had the highest probability of reducing deterioration of global health status and QoL (85%). • When integrating HR-QoL with overall survival, atezolizumab plus bevacizumab outperformed all other treatments. • Atezolizumab plus bevacizumab provides the best balance between QoL preservation and overall survival benefit compared to other systemic therapy options in unresectable or advanced HCC.
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Slide Lenvatinib/TKI monotherapy preferred IO combination • No approved options in 2L • Fostrox + Lenvima target population 2L • Data presented at ASCO & ESMO-GI confirming the promise of fostrox + lenvatinib combination Recent data cements current treatment algorithm in, further strengthening the potential for Fostrox to be first in 2L HCC 12 Advanced HCC – Treatment Algorithm IO combination Lenvatinib (or Sorafenib) • Majority treated with IO combo • Tecentriq + Avastin preferred with recent data strengthening its position 1L 90% 10%
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Slide 2nd line HCC – a large and growing commercial opportunity with significant need for new treatment options3 131Rumguy et al. Journal of Hepatology 2022 2Huang et al., Nature Reviews, Gastroenterology & Hepatology, Vol 18, 2021 3GlobalData 2021 and internal analysis 2024 2030 2030 Upside $1.3 bn RoW – 28% China – 30% EU 5 – 17% US – 25% $2.8 bn Global 2L HCC market3 Growth driven by: HCC to increase +122% in the US and +82% in China2 by 2030, caused by fatty liver disease With improved 1L treatment, more patients will be fit enough for 2L, 50% → 70% New, approved treatment options increase average treatment duration to 7 months by 2030 2030 Upside: Average treatment duration increases to 10 months based on fostrox + Lenvima® study $4.0 bn +115%
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Slide Growth in Fatty Liver Disease expected to drive an alarming increase in liver cancer cases1 14 HCC market growth further spurred by more and better treatments enabling patients to be treated longer The number of newly diagnosed liver cancer patients each year is expected to double Fatty Liver Disease (MASLD/MASH) expected to rise dramatically over the next 30 years 1JAMA Network Open. 2025;8(1):e2454707
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Slide Key patent approval in Japan for fostrox + Lenvima extending protection until 2041, complementing previous approval in EU 15 Generates critical extension of patent protection until 2041 Now approved in Japan, EU and Australia which indicates likelihood of other key regions to follow Covers the combination of fostrox + Lenvima for the treatment of HCC and metastases to the liver
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Slide 16 Financial highlights Q2
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Slide Financial summary Q2, 2025 17 • Net turnover for Q2 was SEK 1.5 million • Operating loss for Q2 was SEK -23.2 million • Cash flow from operating activities for Q2 was SEK -26.2 million • Cash balance end of Q2 was SEK 38.2 million Consolidated Income Statement, summary (SEK m) 2025 2024 2025 2024 2024 Net turnover 1.5 1.1 2.1 1.6 3.5 Other operating income 0.3 0.1 0.5 0.3 1.0 Total income 1.8 1.2 2.6 1.9 4.5 Other external expenses -17.0 -30.3 -23.2 -51.0 -101.3 Personnel costs -7.1 -7.6 -14.1 -14.1 -27.2 Depreciations and write-downs -0.7 -0.7 -1.4 -1.4 -2.7 Other operating expenses -0.2 0.0 -0.5 -0.1 -0.6 Operating profit/loss -23.2 -37.3 -36.5 -64.7 -127.3 Net financial items -0.2 1.4 -0.1 2.7 4.0 Profit/loss after financial items -23.3 -36.0 -36.6 -62.0 -123.3 Tax - - - - - Net profit/loss for the period -23.3 -36.0 -36.6 -62.0 -123.3 Full yearQ1 - Q2Q2
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Slide 18 Q/A
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Slide months No 2nd line treatments approved in advanced HCC Designed to enable breakthrough designation and support accelerated approval process Absence of effective treatment options in 2nd line enables first- to-market opportunity for fostrox + Lenvima >$2.5bn Market opportunity in 2nd line HCC >$2.5bn, with significant upside potential 2nd line HCC market by 2030, fastest growing cause of cancer death in US4 Significant upside in liver metastasis from other solid tumors 1Chon et al., ESMO, 2024, Poster 986 2Based on data from previous 2L phase 3 HCC studies with Stivarga, Cyramza & Cabometyx and investigator initiated prospective & retrospective 2L studies with Lenvatinib 3Evans et al ASCO GI, 2021 4Ma et al., Cancer, June 15, 2019; 2089-2098 No DNA damage in healthy liver tissue DNA damage in tumor tissue Fostrox + LEN (n =21)1 Median TTP, mo 10.9 10.9 months time to progression, substantially better than SoC1,2 Oral, liver-activated small molecule inducing DNA damage in tumor cells, sparing healthy liver cells3 0 2 4 6 8 10 12Median TTP/PFS – Months Fostrox + Lenvima Other 2nd line studies* Unique, liver-targeted approach in HCC Liver-guided delivery – prodrug Tumor-selective payload – troxacitabine 19 Fostrox (fostroxacitabine bralpamide) The first oral, liver-targeted treatment tailored for HCC *see slide 20 for details regarding individual study data
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Slide 20 Thank You!