Slide 1: Dimerix Releases Investor Presentation & Visual Recording
For Immediate Release DIMERIX RELEASES INVESTOR PRESENTATION & VISUAL RECORDING MELBOURNE, Australia, 19 August 2025: Dimerix Limited (ASX: DXB) a biopharmaceutical company with a Phase 3 clinical asset in inflammatory disease, is pleased to release an updated investor presentation and accompanying
Slide 2: For further information, please visit our website
For further information, please visit our website at www.dimerix.com or contact: Dr Nina Webster Jane Lowe Dimerix Limited IR Department Chief Executive Officer & Managing Director Tel: +61 411 117 774 Tel: +61 1300 813 321 E: jane.lowe@irdepartment.com.au E: investor@dimerix.com Follow us on Linked
Slide 3: Dimerix Forward Looking Statement
Dimerix Forward Looking Statement This release includes forward-looking statements that are subject to risks and uncertainties. Although management believes that the expectations reflected in the forward looking statements are reasonable at this time, Dimerix can give no assurance that these expecta
Slide 4: Investor Presentation
Developing new therapies to treat inflammatory causes of kidney disease with unmet clinical needs Investor Presentation August 2025 Authorised for lodgement by the Board of the Company
Slide 5: Forward looking statements
Forward looking statements This presentation includes forward-looking statements that are subject to risks and uncertainties. Although we believe that the expectations reflected in the forward looking statements are reasonable at this time, Dimerix can give no assurance that these expectations will
Slide 6: Overview: Phase 3 Global Opportunity
Overview Phase 3 Global Opportunity 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 payments 3 clinical trial
Slide 7: Mechanism of Action, Pre-clinical, Manufacturing
Mechanism of Action Precision therapy to disrupt inflammatory feedback loops in the kidney of patients with FSGS 1 Pre-clinical FDA confirmed proposed pre-clinical safety package sufficient to support marketing submission2 Manufacturing Commercial scale up in place – manufacturing sites in USA3 Enco
Slide 8: Cycle of damage in glomerular diseases
Cycle of damage : in glomerular diseases What is FSGS? 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 pressure causes inflam
Slide 9: Cycle of damage in glomerular diseases
Cycle of damage : in glomerular diseases Existing blood pressure medication What is FSGS? 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 pressure decreasing inflam
Slide 10: DMX-200: mechanism of action
DMX-200: mechanism of action 200 * • CCR2 is required for recruitment of inflammatory cells Macrophages, n/area 150 to the kidney 100 † † 50 †§ Macrophage infiltration1 DMX-200 blocks CCR21 0 Sham Vehicle DMX-200 ARB DMX-200 +ARB • Macrophage/monocyte: regulate inflammatory cells 20 DMX-200 reduces
Slide 11: Measuring kidney damage – surrogate endpoints
Measuring kidney damage – surrogate endpoints 1. Estimated glomerular filtration rate (eGFR) 2. Proteinuria 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 in the urine2 kidney •
Slide 12: DMX-200: Phase 2 met primary and secondary endpoints
DMX-200: Phase 2 met primary and secondary endpoints Clinically meaningful outcomes achieved for patients,2,3 with no safety issues Average reduction of 17% in proteinuria after 16 weeks treatment on DMX-200 versus placebo1 “Any reduction in proteinuria could yield years of preserved native kidney f
Slide 13: 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 Total number of patients 225 54 Patients recruited, Patients enrolled over into required - anticipated H2 randomised and dosed2 open labe
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 better biomarkers or surrogate outcome meas
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 full approval, and potential for accelerated approval for DMX-2001 Assuming strong Assuming FDA Timing subject to correlation to risk aligned with mid- regu
Slide 16: 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 to expedite drug development and approval1,2 USA EU Japan Current prim
Slide 17: Competitive landscape in FSGS
Competitive landscape in FSGS No approved therapies for FSGS Low competition DMX-200 is the only inflammatory modulator in development Phase 1 Phase 2 Phase 3 Company DMX-200 Inflammatory modulator Sparsentan AT1R/ETAR dual inhibitor – Failed Phase 3 eGFR endpoint: resubmitted to FDA on proteinuria
Slide 18: FSGS market – potential for growth
FSGS market – potential for growth ➢ Prevalence refers to the total number of existing Biopsy cases (new and old) ➢ 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 rates increase >200,000 Gl
Slide 19: Pricing of rare kidney disease drugs
600,000 USA retail price for IgAN products 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 drug price negotiations 200,000 100,000 0 Filspari3 Tarpeyo3
Slide 20: A partner with proven infrastructure to deliver DMX-200
A partner that has existing/proven infrastructure to 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, exponentially increasing collective knowledge & exper
Slide 21: Summary of licensing deals for DMX-200 to date
Summary of licensing deals for DMX-200 to date Licensing deals collectively Dimerix has successfully partnered DMX-200 across key markets valued up to 1 2 3 4 ~AU$1.4 United States EU, CA, AU, NZ GCC, Iraq Japan billion in total upfront and potential milestone fees plus royalties1 AU$0.5 AU$7.2 AU$4
Slide 22: Potential for additional partnering opportunities
Potential for additional partnering opportunities Significant potential additional global deal value remains, as Dimerix pursues and progresses licensing opportunities with potential partners outside the licensed territories, including in Mainland China
Slide 23: Corporate overview
Corporate overview S H A R E P R I C E Ticker Symbol ASX: DXB Cash Balance (Jun25) $68.3 million Market Capitalisation1 $282 million Share price1 $0.47 Total ordinary shares on issue1 600,184,606 Average Daily Liquidity by value for $1.12 million past 30 trading days2 S UBSTA N T IA L S H A R E H O
Slide 24: Potential catalysts CY 2025
Potential catalysts CY 2025 1 2 3 Q1/Q2 Q3/Q4 Potential 2025 2025 upside DMX-200 licensed in US for up to ➢ Outcome of PARASOL working group analysis anticipated ➢ Additional licensing partners for DMX- ~AU$940 million1 Q3 20255 200: Dimerix continues to pursue DMX-200 licensed in Japan for up to ➢
Slide 25: ESG Statement
(ASX:DXB) 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 Dimerix commitment to
Slide 26: Dimerix board
Dimerix board Previous experience: Previous experience: Previous experience: Previous experience: Previous experience: (2) (1) (Faulding)(1) • Senior pharmaceutical executive • Experienced in product • Extensive biotech drug • Experienced executive in • Experienced technology and with a demonstrated
Slide 27: Dimerix management
Dimerix management Previous experience: Previous experience: Previous experience: Previous experience: Previous experience: (2) (1) • Experienced in product • Experienced CFO & Co.Sec • 35 years international experience • Experienced pharmaceutical • Experienced pharmaceutical development, commercia
Slide 28: Medical Advisory Board
Medical Advisory Board Professor of Clinical Trials and Professor of Medicine & Mayer Professor of Renal An attending physician and Renal Physician and Head of Graduated from Haverford Assistant Professor in the Personalized Medicine: Molecular & Cellular Medicine: Department of Director of the Kidn
Slide 29: Renal disease landscape
Renal disease landscape “A squeaky wheel waiting for grease: 50 years of kidney disease management in the US”1 Historical lack of incentives 2018: workshops and 2019 changes in US federal Public health policy, and public policy have regulatory acceptance of policy and rapid adoption of legislation a
Slide 30: Clinical study change: use of surrogate endpoints
Clinical study change: use of surrogate endpoints A surrogate endpoint is an intermediate outcome which substitutes the hard endpoint for a disease (e.g. kidney failure), FDA led working Dimerix starts group, called which can take much longer to achieve recruiting patients PARASOL, initiated for glo
Slide 31: Kidney disease is high interest area for pharma
Kidney disease is high interest area for pharma Prevalence of Kidney Failure, 2001-20232 Kidney disease is the third-fastest-growing cause of death globally1 • In the US alone, the number of people with kidney failure increased by >200% from 2001 to 20232 Number of patients • By 2040, it is expected
Slide 32: DMX-200 – working on inflammatory signalling pathway
DMX-200 – working on inflammatory signalling pathway A CCR2 inhibitor working synergistically alongside the current standard of care (AT1R blocker): G protein-coupled receptor (GPCR) 1. ASX release: 09May2022; 2. ASX releases: 14Dec15, 21Nov18, 07Jun21; 3. ASX release and investor presentation 29Jul
Slide 33: DMX-200 unique heteromer pharmacology
DMX-200 unique heteromer pharmacology Macrophage infiltration Proprietary discovery platform (Receptor-HIT) identified: • Formation of AT1R and CCR2 heteromers; • Novel pharmacology (potentiation of signaling) Proteinuria • Dual antagonism required for completed inhibition Retained podocyte numb
Slide 34: DMX-200 Phase 2 effect on inflammatory biomarker
DMX-200 Phase 2 effect on inflammatory biomarker1 Average baseline MCP-1 versus Change in MCP-1 over time on uMCR normalised to baseline v time average baseline proteinuria DMX-200 versus placebo N=7, GeoMean 50% 1.5 uMCR normalised 0% 1.0 -37%* -39%* -50% 0.5 MCP-1 levels reduced high MCP-1 correla
Slide 35: Intellectual property and exclusivity
Intellectual property and exclusivity 7/10 years 2032 Orphan exclusivity2 in 2042 Method of Use Method of Use many territories Global application1 Granted3 any CCR2 antagonist with any CCR2 inhibitor with any endothelin A receptor any ARB for any kidney for any disease disease Paediatric exclusivity