Medivir AB · OMXSTO:MVIR
Medivir AB — Redeye Fight Cancer Seminar 2021
28 slides from Medivir AB's conference presentation, Jan 21, 2021
Slide 1: Medivir Redeye Fight Cancer Seminar
MEDIVIR REDEYE FIGHT CANCER SEMINAR JANUARY 21, 2021
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: Table of content
Table of content Slide 3
Slide 4: Table of content
Table of content 1. Executive summary 2. Birinapant deal 3. Rights issue 4. MIV-818 5. Other assets 6. Summary Slide 4
Slide 5: Executive summary
Executive summary Proprietary clinical asset • MIV-818 – A liver directed nucleotide prodrug Founded: 1988 • In phase Ib clinical development Listed: Nasdaq OMX • Opportunities for breakthrough oncology indications Location: Stockholm Cash position: c. SEK 83M1) Recent news Market Cap: SEK 470M2) •
Slide 6: Focused clinical program
Focused clinical program Nucleotide prodrug Indication Research Preclinical Phase I Exclusivity MIV-818 Liver cancer IP : 2035 Partnered assets in clinical development Compound Mechanism Indication Phase I Phase II Partner Exclusivity Birinapant SMAC mimetic HNSCC2) IP : 2034 Multiple clinical progr
Slide 7: Medivir enters into exclusive licensing agreement with IGM Biosciences for birinapant
Medivir enters into exclusive licensing agreement with IGM biosciences for birinapant Slide 7
Slide 8: Licensing agreement with IGM Biosciences
Licensing agreement with IGM Biosciences • Medivir and IGM Biosciences (IGM) have entered into an exclusive licensing agreement for birinapant • IGM is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies • IGM will receive global development rights for
Slide 9: Licensing agreement with IGM Biosciences
Licensing agreement with IGM Biosciences • Medivir will receive an upfront payment of USD 1 million upon signing the agreement, followed by an additional USD 1.5 million when birinapant is included by IGM in a clinical phase I study • Should birinapant be successfully developed and approved, Medivir
Slide 10: Preferential rights issue
Preferential rights issue Slide 10
Slide 11: Rights issue of SEK 170M
Rights issue of SEK 170M • If the Rights Issue is fully subscribed, the Company’s share count will increase from 24,287,818 shares to 48,564,223 shares • Announcement of preliminary subscription result in the Rights Issue on Feb 5, 2021 Slide 11
Slide 12: MIV-818 Mode of action and preclinical data
MIV-818 Mode of action and preclinical data Slide 12
Slide 13: MIV-818: A liver-directed nucleotide
MIV-818: A liver-directed nucleotide • MIV-818 is an oral prodrug • Once absorbed from the GI-tract, MIV-818 is transported to the liver • The prodrug is taken up by liver cancer cells and converted into troxacitabine triphosphate (TRX-TP) • TRX-TP is incorporated into DNA and causes double-strand D
Slide 14: Troxacitabine - Background
Troxacitabine - Background • Developed by Shire Biochem Inc. and SGX pharmaceuticals • Nucleoside analogue with anticancer activity • Administration route, intravenous injection • More than 700 patients have received the drug in phase I/II/III trials • In a 48 patient phase I/II trial in AML, 5 pati
Slide 15: Preclinical evidence for MIV-818 liver targeting
Preclinical evidence for MIV-818 liver targeting Compound Route Dose Liver TRX-TP/Plasma (µmol/kg) TRX (AUC ratio) Troxacitabine (TRX) iv 80 <0.016 MIV-818 oral 80 1.9 • MIV-818 exhibited substantial liver targeting by preferential formation of the active TRX-TP metabolite in liver of rats • MIV-818
Slide 16: MIV-818 shows efficacy in preclinical HCC models
MIV-818 shows efficacy in preclinical HCC models Inhibition of tumor growth in mouse HCC Inhibition of patient-derived HCC cell lines in vitro xenograft models in vivo In h ib itio n o f P D C s ( n = 1 5 ) M IV - 8 1 8 d o s e -r e s p o n s e in H e p G 2 m o d e l 100 D o s in g (p o B ID x 5 d )
Slide 17: Summary
Summary • Preclinical evidence of increased liver targeting with MIV-818 vs i.v. troxacitabine • MIV-818 has demonstrated efficacy in multiple preclinical HCC models • Significantly better tumor inhibition vs. MKIs in HepG2 xenograft mouse model • Predictive dose response • Evidence of activity in h
Slide 18: MIV-818 Clinical development
MIV-818 Clinical development Slide 18
Slide 19: MIV-818: Phase Ia objectives
MIV-818: Phase Ia objectives Primary objectives • To assess safety and tolerability of escalating doses of MIV-818 in patients with hepatocellular carcinoma (HCC), Intra hepatic cholangiocarcinoma (iCCA), or metastatic liver disease and to establish the phase Ib start dose Key secondary and explorat
Slide 20: MIV-818: Selective effect signal in liver cancer in phase Ia
MIV-818: Selective effect signal in liver cancer in phase Ia • Clear signs of cell death, measured as DNA damage, observed in liver biopsies from tumor tissue in MIV-818 treated patients • The tumor selective effect is an early proof-of-concept of the intended liver-directed effect in patients Pre-d
Slide 21: MIV-818: Conclusions from phase Ia
MIV-818: Conclusions from phase Ia • Adverse events were generally mild and the few severe adverse events were reversible • Only low levels of MIV-818 and acceptable exposure to troxacitabine were observed in blood after two treatment cycles • Liver biopsies showed selective DNA damage in tumor tiss
Slide 22: MIV-818: Clinical development plan in advanced liver cancer
MIV-818: Clinical development plan in advanced liver cancer Phase Ib -Part A Phase Ib - Part B Phase Ib monotherapy Phase Ib add-on to SoC (n=up to 30) (n=up to 30) Next phase add-on to SoC Interpatient dose escalation Interpatient dose escalation Example: MIV-818 + SoC vs. Placebo + SoC 3+3 design
Slide 23: Other assets
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Slide 24: Two clinical programs for partnering/out-licensing
Two clinical programs for partnering/out-licensing Compound Mechanism Indication Phase I Phase II Phase III Exclusivity Remetinostat Topical HDAC MF-CTCL1) IP : 2034 BCC MIV-711 Cathepsin K OA2) IP : 2034 inhibitor 1) Indications: basal cell carcinoma, squamous cell carcinoma, mycosis fungoides cuta
Slide 25: Executive summary
Executive summary Proprietary clinical asset • MIV-818 – A liver directed nucleotide prodrug Founded: 1988 Listed: Nasdaq OMX • In phase Ib clinical development Location: Stockholm • Opportunities for breakthrough oncology indications Cash position: c. SEK 83M1) Recent news Market Cap: SEK 470M2) •
Slide 26: Board of Directors
Board of Directors Chairperson of the Board. Member of the Board since 2015. Member of the Board since 2017. Education: B.Sc. in Economics and Business Administration from the Education: Professor of Tumor Biology at Uppsala University, Stockholm School of Economics. Faculty of Medicine, since 1986.
Slide 27: Key management members
Key management members Chief Financial Officer President and CEO Education: B.Sc. in Economics and Business Administration. Education: Ph.D. Medical Sciences, Karolinska Institutet. Employed: 2019 Employed: 2020 Background: Twenty years of experience in business and finance. Previously Background: F
Slide 28: Shareholder list
Shareholder list De stérsta aktieagarna 2020-12-30 Innehav Réster i % FORSAKRINGSAKTIEBOLAGET, AVANZA PENSION 2171 184 8.94% Nordea Investment Funds 1999 459 8.23% LINC AB 1008 283 415% CREDIT SUISSE (LUXEMBOURG) S.A 623 675 2,57% ALANDSBANKEN | AGARES STALLE 584 062 2,40% NORDNET PENSIONSFORSAKRING