Medivir : Presentation

MEDIVIR

INNOVATION IN AREAS OF HIGH UNMET MEDICAL NEED

MARKET

A pipeline of first-in-class programs targeting patient populations without approved treatment options

AREA

PROJECT PARTNER DISEASE

PRE-CLINICAL

PH 1 PH 2 PH 3 ON

FINANCIALS PROJECT STATUS

Fostroxacitabine bralpamide (Fostrox)

MIV-711

• Phase 1b/2a combo study completed 2025

• 80 patient randomized phase 2 combo study start near-term

• Phase 2 clinical PoC study in development

100% Medivir

100% Medivir

Osteogenesis Imperfecta

HCC (mono) HCC (combo)

In-house development

In-house development

IN-HOUSE PROGRAMS

PARTNERED PROGRAMS - NO FURTHER INVESTMENT REQUIRED BY MEDIVIR

Xerclear

Remetinostat

MIV-701 / VBX-1000

MET-X

GSK, SYB

Biossil

Vetbiolix

Infex Therapeutics

Herpes

CTCL, BCC, SCC

Periodontal disesase in dogs

Critical MBL Infections

Slide

Royalties

Royalties & up to

$60m in milestones

Royalties & revenue share agreement on Vetbiolix partnering

Revenue Share Agreement

• Registration in China

• Out-licensed in Q4 2025

• Phase 2/3 study start

• Randomized phase 2 results during Q4 2026

• Phase 1 study start in 2026

  
  
  

  Transformational progress

  SEK 45 million directed issue to Carl Bennet AB, enabling MIV-711 clinical development in Osteogenesis Imperfecta, with market opportunity comparable to fostrox in HCC, while strengthening company financial position

  FLEX-HCC in advanced primary liver cancer, study preparations with Korean Cancer Study Group continues to progress, all sites selected, including the three largest hospitals

  VBX-1000 (MIV-701) initiation of randomized, placebo-controlled study to confirm disease-modifying benefit & unlock blockbuster potential, results expected Q4 2026

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  MePdlaivcier;hSotlrdoenrgatgreancdk-arecord in out-licensing

  Partnerships to effectively building shareholder value

  2 approved drugs (Xerclear & Olysio) developed & out-licensed

  3 first-in-class R&D programs out-licensed

  2 in-house programs funded through phase 2, data read-outs in 27/28, for additional partnering potential

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  Leadership & board with extensive early & late stage drug development experience

  • CE0 - Jens Lindberg

  • > 25 years in pharma with focus in Oncology, late-stage development & commercialization

  • Other experience includes interim CEO for Sedana Medical AB and Director Investor Relations at AstraZeneca.

  • CMO - Pia Baumann, MD PhD

  • Medical & Radiation Oncologist

  • >10 yrs in clinic & academia followed by >15 yrs in global pharma/biotech roles

  • CFO - Patrik Norgren

  • >20 years experience from CFO and financial management roles across multiple sectors in listed and private companies.

  • CSO - Fredrik Öberg, PhD

  • >25 yrs experience in cancer research with >50 scientific articles and holds several patents.

  • During the last 10 years focused on industrial drug discovery and development projects in oncology.

  • Chairman of the Board - Anders Hallberg

    
    
    

  • Master's degree in economics from Lund University

  • >25 years of experience in healthcare investments, including majority owner of HealthInvest Partners AB

  • Dr. Uli Hacksell, PhD, Organic Chemistry

  • Over 30 years pharma & biotech experience, including 10 years' experience as CEO of publicly owned companies

  • Has served as CEO and as Chairman of the Board at Medivir

  • Dr. Angelica Loskog, PhD, Clin. Immunology

  • CEO Lokon Pharma & scientific advisor at VC Nexttobe

  • More than 25 year's academic drug development experience within immune oncology

  • Dr. Anna Törner, PhD, Statistics

  • Broad experience from drug development

  • Founder consulting company SDS Life Science within drug development, regulatory affairs and statistics.

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IN-HOUSE PROGRAMS

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Placeholder agenda

Improving life for advanced liver cancer (HCC) patients

Displacing chemotherapy with the first oral, liver-activated inhibitor of DNA replication

Improving life for advanced liver cancer (HCC) patients

Fostrox - The first oral, liver-targeted treatment for advanced HCC

First-to-market opportunity in 2nd line HCC market valued >$2.5bn

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45% of US adults are obese

More than 25% have Fatty Liver Disease

Fatty Liver Disease increases risk of Liver Cancer 17-fold

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Growth in Fatty Liver Disease expected to drive an alarming increase in liver cancer cases1

Fatty Liver Disease (MASLD/MASH) expected to rise dramatically over the next 30 years

The number of newly diagnosed liver cancer patients each year is expected to double

HCC market growth further spurred by more and better treatments enabling patients to be treated longer

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1JAMA Network Open. 2025;8(1):e2454707

Fostrox + Lenvima is at the forefront of development in population where no treatments are approved today

1L

90%

10%

• Majority treated with IO combo

• Tecentriq + Avastin preferred with recent data strengthening its position

Lenvatinib (or Sorafenib)

• Data presented at ASCO GI & ESMO confirms that

fostrox + lenvatinib is at the forefront in 2L

2L

• No approved options in 2L

• Fostrox + Lenvima target population

Lenvatinib/TKI monotherapy preferred

IO combination

IO combination

Advanced HCC - Treatment Algorithm

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2nd line HCC - a ~$3bn commercial opportunity3

+115%

$2.8 bn

$1.3 bn

US - 25%

EU 5 - 17%

China - 30%

RoW - 28%

$4.0 bn

2024 2030 2030 Upside

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%

  2030 Upside:

• Average treatment duration increases to 10 months based on fostrox + Lenvima® study

Global 2L HCC market3

1Rumguy et al. Journal of Hepatology 2022

2Huang et al., Nature Reviews, Gastroenterology & Hepatology, Vol 18, 2021

3GlobalData 2021 and internal analysis

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Absence of effective treatment options in 2nd line HCC

Treatment algorithm - major need for new 2nd line options

Competitive landscape in 2nd line HCC highlights lack of novel mechanisms in development with fostrox + Lenvima at the forefront

2nd line treatment

• IO combinations Standard of Care -Tecentriq + Avastin

• Numerous studies ongoing evaluating various other IO combinations

1st line treatment

"We are becoming greedy, trying to have 8 different regimens in the 1L setting and none of us know what to do after.

If I had my way, the focus should really be on 2L treatment and beyond"

• No approvals or scientific evidence to support treatment choice in 2nd line

• Few ongoing studies in 2nd line

Rachna T Schroff, University of Arizona Cancer Center

Late Breaking Abstract session at ESMO, September 2024

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*Sorafenib was the first approved 1st-line treatment for HCC. Although approved for 2nd-line use, guidelines recommend against it due to a lack of evidence showing efficacy after immunotherapy combinations.

**Nivolumab + Ipilimumab were approved for patients post-sorafenib but are now moving into 1st line HCC treatment (positive phase III, awaiting approval (source)).

Fostrox - tailored for the specific needs of HCC

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Fostrox - designed to selectively kill tumor cells in the liver

Prodrug transports inactive payload to the liver, where it is rapidly activated by liver enzymes1

Kills tumor cells2,3,4

Spares healthy cells2,3,4

Liver-guided delivery -prodrug

Tumor-selective payload -troxacitabine

1Bethell, R. et al P-035, ILCA 2016

2Kukhanova, M et al J Biol Chem 1995 3Albertella, M. et al EASL Summit P01-05, 2018 4Öberg F. et al, EASL PO-221, 2022

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Fostrox MoA - tailored for HCC to achieve targeted DNA damage in liver tumor cells with minimal impact on healthy liver cells

Inactive Prodrug cytotoxic

Cell death in tumor cells

Prodrug transports inactive payload via first-pass metabolism to the liver1

1

Mechanism of Action video

Fostrox taken as oral tablet

Rapidly activated by liver enzymes

2

Trapped inside liver cells for maximum liver exposure and minimal systemic spread2,3,4 3

No impact on healthy cells

3

Causes selective cell killing effect in tumor cells, sparing healthy liver cells as they very rarely divide2,3,4

1Bethell, R. et al P-035, ILCA 2016

2Kukhanova, M et al J Biol Chem 1995 3Albertella, M. et al EASL Summit P01-05, 2018 4Öberg F. et al, EASL PO-221, 2022

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100-fold higher liver targeting vs IV administration & selective DNA damage in tumor cells enabling highly targeted mechanism

>100-fold higher liver targeting with fostrox than iv troxacitabine in rats

Liver tumor cells divide significantly more often than non-tumor cells1

Fostrox induces DNA damage in tumor cells, sparing normal liver tissue2

% K i 6 7 p o s i t i v e n u c l e i

Compound	Route	Dose (µmol/k g)	AUCLiver (nmol*h/ g)	AUCPlasma (µmol*h/L)	AUC ratio (Liver/ Plasma)
Troxacitabine	iv	80	<1.2	80	<0.016
Fostrox	oral	80	10	5.4	1.9

1 0 0 1 0 1 0 . 1

Cell proliferation rate

K i 6 7 ( b i o p s y o n l y ) N o n - t u m o u r T u m o u r

Normal liver tissue*

Tumor tissue*

Fostrox-induced DNA-damage indicated by pH2AX immuno-histochemistry (IHC) staining of liver biopsy from phase 1b monotherapy

1Albertella, M. et al EASL Summit P01-05, 2017

2Öberg F. et al, EASL PO-221, 2022

*Induced DNA damage indicated by pH2AX IHC staining (brown color) in patient biopsies

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Fostrox + Lenvima shows promise of improved outcomes in 2L HCC

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Fostrox Clinical Development Program; monotherapy PoC established, focus on combination approach in 2L HCC

Phase 1a Mono Phase 1b Mono Phase 1b Combo Phase 2a Combo

Future -

Phase 2 Combo

Single patient Intrapatient dose escalation

3+3 dose escalation

Fostrox + lenvatinib dose escalation

10-40 mg

Fostrox + lenvatinib dose expansion RP2D

Fostrox + lenvatinib vs lenvatinib

Monotherapy PoC established, published

Presented at ASCO GI, Jan 2024, ESMO-GI, June 2024 and ESMO, September 2024

in Journal of Hepatocellular Carcinoma Study closed in Q4 2024 with 3

remaining patients transitioned to compassionate use

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