Medivir Ab · OMXSTO:MVIR

Medivir Ab — Q4 2023 Earnings Presentation

31 slides from Medivir Ab's earnings presentation, Feb 15, 2024

  1. Slide 1: Medivir Q4 Report 2023

    MEDIVIR Q4 REPORT 2023

  2. Slide 2: Placeholder agenda

    Placeholder agenda Significant progress in Q4 Fostrox + Lenvima efficacy goes from strength to strength TNG348 initiating phase 1/2 2 Slide

  3. Slide 3: 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

  4. Slide 4: Today’s presenters

    Today’s presenters  Jens Lindberg  Joined Medivir 2022  Magnus Christensen  > 25 years pharma with focus in Oncology.  Joined Medivir 2019  Has led global product strategy development for late-  > 20 years experience in finance, including CFO at stage compounds as well as product launch for O

  5. Slide 5: Fostrox + Lenvima keeps improving, outperforming current Standard of Care in 2L HCC

    Fostrox + Lenvima keeps improving, magnitude of clinical benefit outperforming current Standard of Care in 2L HCC • Fostrox + Lenvima efficacy data in 2L HCC keeps improving • Median time to progression has increased to 6.3 months, significantly better than previous studies in 2L HCC Fostrox + • Pat

  6. Slide 6: Smart, targeted chemotherapy to improve treatment outcomes

    Smart, targeted chemotherapy to improve treatment outcomes Slide 6

  7. Slide 7: 2L HCC – fast-to-market strategy in underserved population

    2L HCC – fast-to-market strategy in underserved population Advanced stage HCC Treatment Algorithm Standard of Care (SoC) Limitations of current SoC Patient Potential3 Immunotherapy combination  ~30% response rate1  US pts ~13.5k 1st line (Tecentriq + Avastin)  TTP ~6.5 months1  Global ~140k No a

  8. Slide 8: Smart, targeted chemotherapy approaches to improve treatment outcomes further for patients

    Smart, targeted chemotherapy approaches to improve treatment outcomes further for patients Selectively delivering chemotherapy to cancer cells while minimizing damage to healthy cells Antigen-specific targeting Organ-specific targeting ADC  For cancers with high Fostrox  For heterogenous cancers e

  9. Slide 9: Fostrox in 2L HCC

    Fostrox in 2L HCC Slide 9

  10. Slide 10: Phase 1b/2a fostrox + Lenvima 2L HCC study with generous inclusion criteria

    Phase 1b/2a fostrox + Lenvima 2L HCC study with generous inclusion criteria  Third line patients (19%) included  High share of extrahepatic metastasis (67%)  Macrovascular invasion all grades allowed Patient Characteristics N = 21  All patients had tumor progression on Mean age (range) 62 y (42

  11. Slide 11: Objective response reported in 24% of patients with tumor shrinkage in 75%

    Objective response (ORR) reported in 24% of the patients with overall tumor shrinkage in target lesion in 75% Best percentage change in target lesion size, local review RECIST 1.1 30% Best % change from baseline in target lesion size 20% 10% 16% 11% 2% 1% 0% 0% -2% -7% -7% Partial Response -10% -14%

  12. Slide 12: Encouraging ability to stay on treatment with disease control

    Encouraging ability to stay on treatment with disease control, >40% of patients still on treatment Local review, disease control & time to progression RECIST 1.1 Patient 1 Patient 6 Patient 7 Patient 15 Patient 14 Patient 13 Objective Response Rate Patient 12 24% Patient 19 (ORR) Patient 20 Disease

  13. Slide 13: Long duration of benefit in patients with limited effect on prior treatment

    Long duration of benefit seen in patients with limited effect on prior treatment, updated median TTP 6.3 months* Fostrox + Lenvima - TTP Patient 1 Patient 6 Patient 7 Patient 15 Patient 14 Patient 13 Patient 12 Patient 20 Patient 19 Patient 16 6.3 Patient 21 months Patient 9 median TTP* Patient 4 Pa

  14. Slide 14: Long duration of benefit in patients with limited effect on prior treatment

    Long duration of benefit seen in patients with limited effect on prior treatment, updated median TTP 6.3 months* Previous line - TTP Fostrox + Lenvima - TTP Patient 1 Patient 6 Patient 7 Patient 15 Patient 14 Patient 13 Patient 12 5.6 Not available Patient 20 Patient 19 Patient 16 6.3 months Patient

  15. Slide 15: Fostrox + Lenvima showed a good safety and tolerability profile

    Fostrox + Lenvima showed a good safety and tolerability profile without any new unexpected events • Fostrox related side effects were mainly Lenvima Fostrox + haematological and temporary with 70% of monotherapy1 Lenvima2 patients staying on the full dose Fostrox dose - 29% modification • Lenvima to

  16. Slide 16: Fostrox + Lenvima efficacy data superior in indirect comparison with Standard of Care

    Fostrox + Lenvima phase 1b/2a efficacy data superior in an indirect comparison with Standard of Care in 2L HCC Expected benefit in 2L RECISTv1.1 Fostrox + Lenvima3 HCC with current SoC1,2 ORR ~10% 24% DCR ~65% 81% Median PFS/TTP ~3.5 months 6.3 months 1Data from previous 2L phase 3 HCC studies with

  17. Slide 17: Pivotal phase 2b; global HCC expert input supports proposed study design

    Pivotal phase 2b; global HCC expert input at ASCO supports proposed study design ahead of FDA interactions Phase 2b: randomized, double-blind study design Primary Endpoint: HCC experts feedback on study design Fostrox 30 mg + • PFS Lenvima Advanced HCC N ~ 140 Secondary Endpoints:  Strong support f

  18. Slide 18: Accelerating fostrox development

    Accelerating fostrox development Q4 ’23 Q1 ’24 Q2 ‘24 H2 ‘24  Updated commercial formulation for pivotal phase 2b study CMC  Process development suitable for commercial manufacture  Manufacture of new GMP campaign for phase 2b Ongoing  Scientific Advisory Council study design Clinical  KOL/inve

  19. Slide 19: Significant future development opportunities beyond 2L HCC

    Significant future development opportunities beyond 2L HCC Beyond HCC Liver metastasis (CRC) Earlier stage HCC iCCA Intermediate stage 1L advanced HCC Adjuvant Follow-on opportunity, 2L advanced HCC triple combo Fast-to-market strategy, • ~140k pts globally combo with Lenvima • 9-10 mts duration • ~

  20. Slide 20: TNG348

    TNG348 USP1 inhibition in HRD+ cancers Slide 20

  21. Slide 21: Broad pipeline with focus on in-house program fostrox

    Broad pipeline with focus on in-house program fostrox IN-HOUSE PROGRAM – FOSTROX PROJECT DISEASE AREA PATIENT POPULATION PRE-CLIN PH 1 PH 2 PH 3 NEXT EVENTS Fostrox HCC Monotherapy (Proof-of-Concept)  Fostrox + Lenvima data read-out Fostrox + Lenvima  Fostrox + Lenvima ph 2b initiation Fostrox + K

  22. Slide 22: TNG348 blocks an important DNA damage repair pathway

    TNG348 blocks an important DNA damage repair pathway USP1 inhibition blocks translesion synthesis USP1 removes ubiquitin from PCNA to complete the repair ae _/* on Mono-ubiquitinated PCNA encircles damaged DNA ubiquitin removal from PCNA Poly-ubiquitinated PCNA accumulates, is degraded and translesi

  23. Slide 23: TNG348 is active alone and in combination with PARP inhibitors

    TNG348 is active alone and in combination with PARP inhibitors In vivo efficacy in PDX models BRCA1 mut Triple negative breast cancer 1 Tumor volume (mm?) 88 8 8 ‘Tumor volume (mm*) o § 10 15 20 2 30 Days post first treatment > Vehicle “# TNG348 100mpk QD = Olaparib 100mpk QD + TNG348 100mpk QD, Ola

  24. Slide 24: TNG348 first-in-human trial design

    TNG348 first-in-human trial design DOSE DOSE EXPANSION PHASE 1/2 STUDY ESCALATION * BRCA‘1/2 mut and other HRD+ BRCA mut breast cancers include ~50% ovarian, 25% T™NG348 breast, 10% prostate and 5% L_ BRCA mut ovarian pancreatic cancers + HRD+ defined by RAD51, PALB2 BRCA mut breast mutation or FDA-

  25. Slide 25: Financial highlights Q4

    Financial highlights Q4 Slide 25

  26. Slide 26: Financial summary Q4, 2023

    Financial summary Q4, 2023 Consolidated Income Statement, summary Q4 Q1 - Q4 (SEK m) 2023 2022 2023 2022 Net turnover 4.4 2.3 7.6 4.4 Other operating income 0.2 0.2 1.4 1.8 Total income 4.7 2.5 9.0 6.2 Other external expenses -16.5 -15.7 -68.9 -69.1 Personnel costs -7.9 -4.8 -27.4 -20.7 Depreciation

  27. Slide 27: Fostrox + Lenvima – Potential to transform 2nd line HCC

    Fostrox + Lenvima – Potential to transform 2nd line HCC Fostrox is a smart, organ-specific chemotherapy that selectively kills liver cancer cells, while sparing healthy cells Fostrox + Lenvima data keeps getting stronger as patients stay on treatment longer than expected, further outperforming curre

  28. Slide 28: Q/A

    Q/A Slide 28

  29. Slide 29: Fostrox + Lenvima – Potential to transform 2nd line HCC

    Fostrox + Lenvima – Potential to transform 2nd line HCC Fostrox is a smart, organ-specific chemotherapy that selectively kills liver cancer cells, while sparing healthy cells Fostrox + Lenvima data keeps getting stronger as patients stay on treatment longer than expected, further outperforming curre

  30. Slide 30: Upcoming activities

    Upcoming activities • EASL Liver Cancer Summit poster presentation, February 23 • Swiss-Nordic Bio, March 7 Slide 30

  31. Slide 31: Thank You!

    Thank You! Slide 31

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