Dimerix Limited · ASX:DXB
Dimerix — Euroz Hartleys Healthcare Forum 2025
34 slides from Dimerix's conference presentation, Feb 4, 2025
Slide 1: Dimerix presents at Euroz Hartley Healthcare Forum
For Immediate Release DIMERIX PRESENTS AT EUROZ HARTLEY HEALTHCARE FORUM MELBOURNE, Australia, 04 February 2025: Dimerix Limited (ASX: DXB), a biopharmaceutical company with a Phase 3 clinical asset in kidney disease, is pleased to advise that CEO and Managing Director, Dr Nina Webster, will be pres
Slide 2: About Dimerix
About Dimerix 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 focussed on developing its proprietary Phase 3 product candidate DMX-200 (QYTOVRA® in some territories),
Slide 3: Euroz Hartleys Healthcare Forum February 2025
@ Dimerix (ASX:DXB) For personal use only Euroz Hartleys Healthcare Forum February 2025 Developing new therapies to treat inflammatory causes of kidney disease with unmet clinical needs
Slide 4: Forward looking statements
Forward looking statements This presentation includes forward-looking statements that are subject to risks and uncertainties. Such statements involve known and unknown risks and important factors that may cause the actual results, performance or achievements of Dimerix to be materially different fro
Slide 5: Corporate overview
Corporate overview 1 Mr P Meurs 75,304,506 13.6% “Cash balance does not include: + $3.1 million- upfront fee from Fuso development & licensing agreement, payable within 40 days of agreement execution + “$4.1 million- payment on fst clinical site opening in Japan from Fuso licensing agreement - antic
Slide 6: For personal use only
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Slide 7: Focal Segmental Glomerulosclerosis (FSGS)
Focal Segmental Glomerulosclerosis (FSGS) FSGS Kidney Damage? GS = Kaey vessels nave to work Focal some Existing blood pressure medication harder under high pressure targets Step 1: angiotensin receptor Me a ood pw 208 interrupts Step 2 - the = i blocker (ARB) lowers blood pressure" igh bloo inflamm
Slide 8: Why are kidneys important? Symptoms of proteinuria
Why are kidneys important? Symptoms of proteinuria For personal use only • • • ➢
Slide 9: Significance of stabilising eGFR curve: primary endpoint
Significance of stabilising eGFR curve: primary endpoint Natural aging kidney * Kidney function can be measured using estimated function slope" = P glomerular filtration rate (eGFR): fo) o how many millilitres of blood is filtered by the oO” FSGS slope — kidney kidney per minute g ven is sie) q * eG
Slide 10: DMX-200: Phase 2 met primary and secondary endpoints
DMX-200: Phase 2 met primary and secondary endpoints Gasper a] - : . A ‘ ‘ veoh >t Clinically meaningful outcomes achieved for patients,? with no safety issues atgre om Gi q 12) =) y reduction in —_ 6 proteinuria could yield years oO _ VK of preserved native kidney Cc iL function and delay the [e) &
Slide 11: FSGS Clinical Study Phase 3 Clinical Trial
For personal use x. (ASX:DXB) FSGS CLINICAL STUDY PHASE 3 CLINICAL TRIAL
Slide 12: ACTION3 Phase 3 clinical trial — next steps
Oj ACTIX2N3 Phase 3 clinical trial — next steps FSGS CLINICAL STUDY Arandomised, double-blind, multi-centre, placebo-controlled study of renal outcomes of DMX-200 in patients with FSGS receiving an ARB 2 Extension > | 72 patients @ 35 weeks : Successful analysis outcome! ana come final analysis (usi
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Slide 14: PMDA regulatory approval received for DMX-200
PMDA regulatory approval received for DMX-200 e Japanese Pharmaceutical and Medical Device Agency (PMDA) approved ACTIONS clinical trial with no further pre-requisite studies* AUTMEA BRERA Pharmaceuticals and Medical Devices Agency For personal use only + Fuso to open clinical sites in Japan to supp
Slide 15: Summary of licensing deals
Summary of licensing deals Licensing deals collectively valued up to AU$458 million in total upfront and potential milestone fees + royalties! Cc + Other licensing 2 3 4 fp stn Taiba Fuso’ deals EU, CA, AU, NZ GCC, Iraq Japan =) AU$10.8m2 AU$0.5 million? AU$7.2 million* ? Upfront] Upfront] Upfront +
Slide 16: For personal use only
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Slide 17: Well positioned to deliver against strategic plan
@ Dimerix GU epranneeeticel company developing innovative new rapies in areas with unmet medical needs, with a core focus aWinflammatory disease treatments such as kidney and =taspiratory diseases. For persona WELL POSITIONED TO DELIVER AGAINST STRATEGIC PLAN ESG Statement Dimerix is committed to in
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Slide 20: Medical Advisory Board
Medical Advisory Board 12) = = —= Professor Professor Professor Associate Professor Dr Muh Geot Wong Professor Associate Professor Cdiddo Heerspink Alessia Fornoni Jonathan Barratt Lesley Inker Howard Trachtman Laura Mariani PhD MD, PhD, FASN MD, PhD, FRCP MD, MS, FRCPC MBBS, PhD, FRCP MD, FASN MD,
Slide 21: Renal disease landscape
Renal disease landscape A squeaky wheel waiting for grease: 50 years of kidney disease management in the US” For personal use on “More change in the past 24 months than the past 24 years: The rapid evolution of [kidney disease] management” Historical lack of incentives and public policy have Icontri
Slide 22: Clinical study change: use of surrogate endpoints
Clinical study change: use of surrogate endpoints ACTING A surrogate endpoint is an intermediate outcome which substitutes the hard endpoint for a disease (e.g. kidney failure), which can take much longer to achieve FSGS CLINICAL STUDY FDA grants first accelerated approval drug based on proteinuria
Slide 23: For personal use only
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Slide 24: For personal use only
$90 For personal use only $80 Ventus+ Novo Nordisk (Worldwide) Ph 1, multiple assets $70 Travere Therapeutics +Vifor Pharma (EU, UK, ANZ) Ph 3, multiple indications $60 Roche +Ionis Pharmaceuticals Aurinia Pharmaceuticals + (Worldwide) Ph3, single asset Otsuka Pharmaceutical (EU, Japan, Russian Fede
Slide 25: Policy change: renal disease healthcare economic burden
Policy change: renal disease healthcare economic burden D> a cS “40 million | fo) adults have kidney 7 disease (“15% of the . . : adult population) in the | Economic cost of kidney failure in the US US in 20211 Total Medicare expenses per year costs for kidney failure patients (2009-2021E) ? $60 © /
Slide 26: FSGS market
FSGS market Cc frequent primary fey glomerular disease Brngs qacelitteclliy that reaches end-stage New diagnosed cases Of all diagnosed FSGS . o renal failure in the US! per year in US? cases globally are in US? CEETENEE] enyReInENe i (7p) the world =) © Cc je) n Multi-billion dollar market potentia
Slide 27: Fuso Pharmaceutical Industries
only, YY FUSO Pharmaceutical Industries, Ltd. uso brings a wealth of experience in pharmaceutical development, sales and marketing across Japan pecialty pharmaceutical company in he field of dialysis and renal/urology SE Developed Japan's first dialysis fluid, strong contribution to development of A
Slide 28: Dimerix/Fuso: strategic partners in kidney disease
wo Dimerix/¥ FUSO: strategic partners in kidney disease y le, FUSO, are greatly honoured to be involved in the development of a new drug for FSGS, as re are currently no approved drugs for the treatment of FSGS. It is a truly valuable opportunity Ses For personal u r us to partner with Dimerix, and
Slide 29: Key elements of Fuso partnership
Key elements of ¥ FUSO partnership FUSO acquires exclusive license to commercialise DMX-200 for FSGS in Japan Dimerix to receive up to ¥10.5 billion (“AU$107 million’) million in upfront and milestone payments, plus royalties * ¥300 million (“AU$3.1 million’) within 40. days of signing ¥400 million
Slide 30: DMX-200 — working on inflammatory signalling pathway
DMX-200 — working on inflammatory signalling pathway only (AT1R blocker): G protein-coupled receptor (GPCR) CCR2 inhibitor working synergistically alongside the current standard of care 4 clinical studies completed to date: positive efficacy signals across studies? volunteers and renal patients | o
Slide 31: DMX-200 unique heteromer pharmacology
DMX-200 unique heteromer pharmacology v . . Proprietary discovery platform (Receptor-HIT) identified: Macrophage infiltration 3 Formation of ATIR and CCR2 heteromers; & - & 15 Novel pharmacology (potentiation of signaling) ¥ Proteinuria E a 1 # # Dual antagonism required for completed inhibition 2 =
Slide 32: For personal use only
For personal use only uMCR normalised to baseline v time N=7, GeoMean 1.5 uMCR normalised 1.0 0.5 On placebo On active 0.0 0 5 10 15 Time • ▪ ▪
Slide 33: Intellectual property and exclusivity
Intellectual property and exclusivity 7/0 year Orphan 2 (@) 42 2032 exclusivity? n Method of Use Method of Use any territori (e) Granted? ny CCR2 inhibitor with ny ARB for any kidney disease Global application’ = any CCR2 antagonist with any endothelin A receptor for any disease Paediatri exclusivit
Slide 34: Advancing the broader pipeline
Advancing the broader pipeline For personal use only Additional longer term pipeline opportunities diversify risk and potential sources of revenue DMX-200 potential label expansion Potential to expand DMX-200 into other rare kidney diseases where inflammation is a key driver of the disease 80 pe) T