Medivir Ab · OMXSTO:MVIR
Medivir Ab — Q3 2024 Earnings Presentation
25 slides from Medivir Ab's earnings presentation, Nov 6, 2024
Slide 1: Medivir Q3 Report 2024
Placeholder agenda Medivir Improving Q3 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: Q3 highlights
Placeholder agenda Mature data at ESMO confirming promise of improved outcome with fostrox + Lenvima® Eisai clinical trial collaboration further validates the potential of fostrox + Lenvima Monotherapy proof-of-concept data published in Journal of Hepatocellular Carcinoma 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: Mature data presented at ESMO confirm promise of improved clinical outcome
Mature data presented at ESMO confirm promise of improved clinical outcome with a median time to progression (TTP) of 10.9 months Slide 5
Slide 6: Medivir activities at ESMO highlighting fostrox + Lenvima data
Medivir activities at ESMO highlighting strength of fostrox + Lenvima data & unmet medical need in 2L HCC Great timing as external focus shifts to 2L HCC Mature data confirming promise of “We are becoming greedy, trying to improved clinical outcome with have 8 different regimens in the 1L fostrox
Slide 7: 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 8: Median TTP 10.9 months compared with Lenvima alone
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) • Median time to progression 10.9 months ORR 24% • Medi
Slide 9: Median TTP 10.9 months, longer than Lenvima monotherapy and other 2L HCC treatments
Median time to progression (TTP) 10.9 months, substantially 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=
Slide 10: Real-world study of Lenvima in 2nd line post Tecentriq/Avastin
Real-world study of Lenvima in 2nd line post Tecentriq/Avastin 1Chon et al. Clinical and Molecular Hepatology 2024 Mar 12 2Chon et al, ESMO 2024, Poster 986 Slide 10
Slide 11: Fostrox + Lenvima data signals superiority compared with Lenvima monotherapy
Fostrox + Lenvima data signals superiority compared with Lenvima monotherapy in 2nd line Lenvima in 2L HCC1 Fostrox + Lenvima4 – Korea “The response rate of 24% is higher than historical data of Lenvima alone in 2L, which is 10% or less. Median PFS/TTP 3.5 mo 10.9 mo 10.9 months TTP is very impressi
Slide 12: Fostrox tumor selectivity and tolerability in combination with Lenvima
Fostrox tumor selectivity and tolerability in combination with Lenvima, provides opportunity for durable efficacy 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 (U/L) 10
Slide 13: Neutrophils and platelets remaining stable over time
Long-term treatment made possible with neutrophils and platelets remaining stable over time 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 microliter platelets pe
Slide 14: International Liver Cancer Association (ILCA) in Toronto
International Liver Cancer Association (ILCA) in Toronto, October 17-19 • Extensive engagement with scientific community for planned phase 2b study, which generated very positive feedback overall • No new data presented in second line advanced HCC, further cementing the need for additional treatment
Slide 15: Monotherapy study published in Journal of Hepatocellular Carcinoma
Phase 1a/1b monotherapy study providing clinical proof-of- concept published in Journal of Hepatocellular Carcinoma • Established clinical proof-of- concept for fostrox monotherapy in patients with cancer in the liver. • The results show that fostrox is safe and tolerable with preliminary anti-tumor
Slide 16: 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 17: Clinical trial collaboration with Eisai
Important clinical trial collaboration with Eisai further validates the potential of fostrox + Lenvima Eisai to provide drug supply for full, randomized phase 2b study while Medivir retains full rights Establishment of a Joint Development Committee with Eisai for planning and execution of the study.
Slide 18: Second line HCC – a large and growing commercial opportunity
Second 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 en
Slide 19: 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 20: Fostrox – The first oral, liver-targeted treatment tailored for HCC
Fostrox – 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 Unique, liver-targeted No DNA damage in DNA damage in Fostrox +
Slide 21: Financial highlights Q3
Financial highlights Q3 Slide 21
Slide 22: Financial summary Q3, 2024
Financial summary Q3, 2024 Consolidated Income Statement, summary Q3 Q1 - Q3 Full year (SEK m) 2024 2023 2024 2023 2023 Net turnover 0.9 0.8 2.5 3.2 7.6 Other operating income 0.3 0.2 0.5 1.1 1.4 Total income 1.2 1.0 3.1 4.3 9.0 Other external expenses -29.6 -18.1 -80.6 -52.4 -68.9 Personnel costs -
Slide 23: Q/A
Q/A Slide 23
Slide 24: Fostrox – The first oral, liver-targeted treatment tailored for HCC
Fostrox – 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 Unique, liver-targeted No DNA damage in DNA damage in Fostrox +
Slide 25: Thank You!
Thank You! Slide 25