Medivir Ab · OMXSTO:MVIR
Medivir Ab — Q1 2024 Earnings Presentation
26 slides from Medivir Ab's earnings presentation, Apr 30, 2024
Slide 1: Medivir Q1 Report 2024
MEDIVIR Q1 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 Fostrox + Lenvima efficacy continues to strengthen Acceleration of fostrox development according to plan MIV-711 granted RPDD & MIV-701 positive ph. 1 in dogs 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 improved TTP to 7 months
Continued acceleration of fostrox development, strengthened by improved TTP to 7 months Slide 5
Slide 6: Fostrox – a smart chemotherapy targeting cancer in the liver
Fostrox – a smart chemotherapy targeting cancer in the liver Oral 1 administration Drug activated 2 in the liver Selectively kills 3 cancer cells Slide 6 *Source: GlobalData 2021
Slide 7: Only 10% of second line patients respond to current therapies
Only 10% of second line patients respond to current therapies First line advanced HCC Second line advanced HCC ~90% of patients treated No approved treatments ~1 in 3 with immunotherapy after 1st line SoC ~1 in 10 responds responds Majority of patients will Only ~10% respond to not respond t
Slide 8: 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 Advanced HCC with generous inclusion 6 centres criteria, including 2L & 3L patients Open-label, single arm, 21 pts Spain 5 centres Final read-out anticipated H2 2024 Next data presentation at ESMO GI,
Slide 9: Significantly higher response rate than current 2L treatments
Significantly higher response rate than current 2L treatments1,2 Best percentage change in target lesion size 30% 20% 16% 24% ORR 10% 11% 2% 1% 0% Fostrox + Lenvima1 0% -2% -7% -7% -10% -14% -14% -15% -16% -18% -22% vs -20% -25% -27% -32% -32% -30% -38% -39% -42% ~10% ORR -40% -50% Current 2L treatm
Slide 10: Fostrox extends TTP compared to current 2L treatments
Fostrox extends TTP compared to current 2L treatments1 Time to progression (TTP) 2L TTP/PFS benchmark (mts)2 Patient 1 Patient 7 +3,5 Patient 14 Patient 19 Fostrox + Lenvima 7,0 Patient 21 Patient 16 Patient 9 Patient 11 Patient 10 2L SoC 3,5 Patient 2 Patients still on treatment Patient 17 0 2 4 6
Slide 11: A majority of patients tolerate full dose of fostrox long-term
A majority of patients tolerate full dose of fostrox long-term1 2 out of 3 patients treated < 30% required fostrox dose with full fostrox dose until modification, much lower progression 66% 29% than traditional chemo Fostrox adverse events Only 1 patient discontinued manageable and temporary
Slide 12: Randomized phase 2b; enhanced study design similar in size & timing post FDA feedback
Randomized phase 2b; enhanced study design similar in size & timing post FDA feedback Phase 2b: randomized, double-blind study design FDA feedback on study design Fostrox dose A + Lenvima Primary Endpoint: N ~ 25 Fostrox dose A or • ORR Support for overall phase 2b study design B + Lenvima Seconda
Slide 13: 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 Data update – Final data CRO selection of FDA interactions ESMO GI read-out FDA engagement to confirm National approva
Slide 14: Second line HCC market worth over USD 2.5 billion by 2030
Second line HCC market worth over USD 2.5 billion by 2030 Large unmet need in fast Total market potential > USD 2.5bn growing population by 2030 & growing3 3rd 4 000 US Europe 5 Japan China RoW leading cause of cancer death worldwide1 3 500 3 000 2 500 +122% 2 000 $m 1 500 HCC expected to increase +
Slide 15: Fostrox – potential to improve second line HCC therapy
Fostrox – potential to improve second line HCC therapy Smart chemotherapy Improving outcomes First-to-market opportunity 2x $2.5bn selectively killing cancer response rate & time to market in patients with no cells in the liver progression approved treatments Slide 15
Slide 16: Pipeline progress with MIV-711 granted RPDD & MIV-701 positive phase 1 in dogs
Pipeline progress with MIV-711 granted RPDD & MIV-701 positive phase 1 in dogs Slide 16
Slide 17: Legg-Calvé-Perthes Disease (LCPD) Affects younger children, no approved medicines
Legg-Calvé-Perthes Disease (LCPD) Affects younger children, no approved medicines Affects younger children Pathology clear but not genetic • Incidence varies greatly and seems to increase with • Temporary disruption of blood latitude supply to the femoral head • Highest risk in Caucasian population,
Slide 18: Scientific rationale for MIV-711 in LCPD
Scientific rationale for MIV-711 in LCPD Cathepsin K inhibition could be key to address LCPD pathology • Necrosis and inflammation increases levels of cathepsin K Bone degradation by cathepsin K which causes bone degradation and femoral head deformity • Cathepsin K inhibition reduces bone degradatio
Slide 19: MIV-711 – Moving forward
MIV-711 – Moving forward Partnership / collaboration approach Outreach following RPDD and ODD approval Evaluate additional disease opportunities for cathepsin K 19 Slide
Slide 20: Positive phase 1 for MIV-701 in animal population with high unmet medical need
Positive phase 1 for MIV-701 in animal population with high unmet medical need & significant commercial potential PARTNERED PROGRAMS DISEASE PROJECT PARTNER PRE-CLIN PH 1 PH 2 PH 3 MARKET AREA Xerclear GSK Herpes Olysio J&J Hepatitis C Positive phase 1 PoC in dogs with periodontal disease (PD) for
Slide 21: Financial highlights Q1
Financial highlights Q1 Slide 21
Slide 22: Financial summary Q1, 2024
Financial summary Q1, 2024 Consolidated Income Statement, summary Q1 Full year (SEK m) 2024 2023 2023 Net turnover 0.5 0.4 7.6 Other operating income 0.1 0.4 1.4 Total income 0.6 0.8 9.0 Other external expenses -20.7 -13.1 -68.9 Personnel costs -6.5 -6.2 -27.4 Depreciations and write-downs -0.7 -0.7
Slide 23: Fostrox – potential to improve second line HCC therapy
Fostrox – potential to improve second line HCC therapy Smart chemotherapy Improving outcomes First-to-market opportunity 2x $2.5bn selectively killing cancer response rate & time to market in patients with no cells in the liver progression approved treatments Slide 23
Slide 24: Q/A
Q/A Slide 24
Slide 25: Fostrox – potential to improve second line HCC therapy
Fostrox – potential to improve second line HCC therapy Smart chemotherapy Improving outcomes First-to-market opportunity 2x $2.5bn selectively killing cancer response rate & time to market in patients with no cells in the liver progression approved treatments Slide 25
Slide 26: Thank You!
Thank You! Slide 26