Dimerix Limited · ASX:DXB
Dimerix — 19th Bioshares Biotech Summit 2025
26 slides from Dimerix's conference presentation, Aug 7, 2025
Slide 1: Dimerix presents at Bioshares Biotech Summit
For Immediate Release DIMERIX PRESENTS AT BIOSHARES BIOTECH SUMMIT MELBOURNE, Australia, 7 August 2025: Dimerix Limited (ASX: DXB), a biopharmaceutical company with a Phase 3 clinical asset in inflammatory disease, is pleased to advise that CEO and Managing Director, Dr Nina Webster, will be present
Slide 2: About Dimerix Limited
About Dimerix Limited Dimerix (ASX: DXB) is a clinical-stage biopharmaceutical company working to improve the lives of patients with inflammatory diseases, including kidney diseases. Dimerix is currently focused on developing its proprietary Phase 3 product candidate DMX-200, for Focal Segmental Glo
Slide 3: Leading the Way
For personal use only Leading the Way Bioshares Summit 7 August 2025 Developing new therapies to treat inflammatory causes of kidney disease with unmet clinical needs 1 Authorised for lodgement by the Board of the Company
Slide 4: Conference theme: Leading the Way
Conference theme: Leading the Way Discuss Phase 3 clinical trial next steps and commercial partnering rationale For personal use only Questions posed to Dimerix: 1. What are the Project PARASOL process and next steps? 2. How does trial unblinding work, and what are the key considerations in any unbl
Slide 5: Forward looking statements
Forward looking statements This presentation includes forward-looking statements that are subject to risks and uncertainties. For personal use only Although we believe that the expectations reflected in the forward looking statements are reasonable at this time, Dimerix can give no assurance that th
Slide 6: Dimerix - In Context
DIMERIX - IN CONTEXT For personal use only 4
Slide 7: Overview
Overview Phase 3 Global Opportunity For personal use only Lead Drug Candidate FSGS Indication a rare disease that No approved treatments Orphan drug designation 4 ~$1.4 billion in total upfront & >$65 million DMX-200 in a Phase causes scar tissue available to treat regulatory, potential in total pay
Slide 8: Key achievements since Bioshares Summit 2024
Key achievements since Bioshares Summit 2024 3rd 4th 1st For personal use only development and license agreement paediatric clinical trial license agreement for for DMX-200 in the sites initiated3 DMX-200 in Japan1 United- States2 Up to ¥10.5 billion Up to US$590 million Adolescent dose (~AU$107m) i
Slide 9: Cycle of damage in glomerular diseases: What is FSGS?
Cycle of damage : in glomerular diseases What is FSGS? For personal use only Kidney vessels have to work harder under high pressure Focal = some 1 Segmental = sections High blood pressure causes hyperfiltration Glomerulo = of the kidney filtering units within blood vessels of the kidney1 2 Constant
Slide 10: Cycle of damage: DMX-200 mechanism
Cycle of damage : in glomerular diseases Existing blood pressure medication What is FSGS? For personal use only targets Step 1: angiotensin DMX-200 receptor blocker (ARB) lowers Focal = some blood pressure1 interrupts Step 2 - the 1 inflammatory pathway to target Segmental = sections High blood pres
Slide 11: Measuring kidney damage – surrogate endpoints
Measuring kidney damage – surrogate endpoints 1. Estimated glomerular filtration rate (eGFR) 2. Proteinuria For personal use only Treatments, such as DMX-200, aim to bring the FSGS slope back up: • A healthy kidney is a good filter and allows little to no protein • can add years to the life of the i
Slide 12: Phase 3 clinical trial
phase 3 clinical trial A randomised, double-blind, multi-centre, placebo-controlled study of renal outcomes of DMX-200 in patients with FSGS receiving an ARB ~286 225 52 For personal use only Total number of patients Patients recruited, Patients enrolled over into required - anticipated H2 randomise
Slide 13: FSGS Working Group - PARASOL
FSGS WORKING GROUP - PARASOL For personal use only 11
Slide 14: Project PARASOL – an FDA-led working group
Project PARASOL – an FDA-led working group Working groups not uncommon to review and recommend potential endpoints for indications without any approved therapies as new information comes to light, for example, results from other trials or identification of For personal use only better biomarkers or
Slide 15: Interim analysis process
Interim analysis process Positive Type C meeting held in March 2025 with US Food & Drug Administration (FDA) on proteinuria trial endpoints For personal use only for full approval, and potential for accelerated approval for DMX-2001 Assuming strong Assuming FDA Timing subject to correlation to risk
Slide 16: Interim analysis unblinding process
Interim analysis unblinding process Regulators require that any interim analysis process not compromise the statistical and medical integrity of the trial and not introduce biases For personal use only BLINDED Personnel BLINDED Clinical Personnel operations Governing principles: Data management (eve
Slide 17: Aligning global regulatory pathways
Aligning global regulatory pathways To accelerate patient access to much needed treatment in areas of serious and life-threatening diseases and unmet medical need, many regulatory authorities have put in place regulatory pathways For personal use only to expedite drug development and approval1,2 USA
Slide 18: Partnering to Perfect
PARTNERING TO PERFECT For personal use only 16
Slide 19: Dimerix financials transformed
Dimerix financials transformed Licensing deals collectively Dimerix has successfully partnered DMX-200 across key markets valued up to ~AU$1.4 For personal use only 1 2 3 4 United States EU, CA, AU, NZ GCC, Iraq Japan billion in total upfront and potential milestone fees plus royalties1 AU$0.5 AU$7.
Slide 20: Selecting our partners
Selecting our partners A partner that has existing/proven infrastructure to For personal use only deliver DMX-200 to as many FSGS patients in need of treatment A partner that recognises the overall value of the asset and views it as a strategic priority 4 exceptional, high quality partners, exponent
Slide 21: The Opportunity
For personal use only THE OPPORTUNITY 19
Slide 22: FSGS market – potential for growth
FSGS market – potential for growth ➢ Prevalence refers to the total number of existing Biopsy cases (new and old) For personal use only ➢ Incidence refers to the number of new cases of a FSGS diagnosis driven by disease within a specified time period rates of biopsy - growth potential as biopsy rate
Slide 23: Rare kidney disease pricing examples
Rare kidney disease pricing examples 600,000 USA retail price for IgAN products For personal use only 500,000 US Medicare Drug Price Negotiation Program1 $USD/annum 400,000 US Medicare Drug Price Negotiation Program exempts orphan 300,000 drugs that treat “only one rare disease or condition’’ from d
Slide 24: Outcome driven strategy
Outcome driven strategy For personal use only Clear strategy, Clear investment Operational Deliver on promise detailed business proposition to excellence in & within budget plan shareholders execution 22
Slide 25: Recognition: drug development is a team sport
Recognition: drug development is a team sport Team 2025 For personal use only Team Webster Teams: …a recipe for success… 23
Slide 26: Well positioned to deliver against strategic plan
(ASX:DXB) For personal use only W E L L P O S I T I O N E D TO D E L I V E R AGA I N ST ST R AT EG I C P L A N ESG Statement Dimerix is committed to integrating Environmental, Social and Governance (ESG) considerations across the development cycle of its programs, processes and decision making. The