Dimerix Limited · ASX:DXB
Dimerix — Investor Presentation (January 2025)
32 slides from Dimerix's investor presentation, Jan 7, 2025
Slide 1: Licensing Webinar - Japan
ACTIONS « Dimerix Licensing Webinar - Japan January 2025 e) LL Developing new therapies to treat inflammatory causes of kidney disease with unmet clinical needs Authorised for lodgement by the Board of the Company
Slide 2: 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 c Gisks and important factors that may cause the actual results, performance or achievements of Dimerix to be materially different f
Slide 3: For personal use only
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Slide 4: Focal Segmental Glomerulosclerosis (FSGS)
Focal Segmental Glomer ulosclerosis (FSGS) GS? Focal =some Segmental = sections Glomerulo = of the kidney filtering units Sclerosis = are scarred w do you asure kidney function? * Historically, measured using “hard” endpoints for kidney disease (kidney failure) -which may not be reached for decades!
Slide 5: FUSO Pharmaceutical Industries, Ltd.
only, YY FUSO Pharmaceutical Industries, Ltd. uso brings a wealth of experience in pharmaceutical development, sales and marketing across Japan pecialty pharmaceutical company in Developed Japan's first dialysis fluid, he field of dialysis and renal/urology strong contribution to development of SE A
Slide 6: Dimerix and 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 7: 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 8: 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* For personal use only + Fuso to open clinical sites in Japan to support recruitment of ACTION3 clinical trial + PMDA confirm
Slide 9: 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 10: For personal use only
For personal use only
Slide 11: ACTION3 Phase 3 clinical trial — next steps
Oj ACTIX2N3 Phase 3 clinical trial — next steps FSGS CLINICAL STUDY +f randomised, double-blind, multi-centre, placebo-controlled study of renal outcomes of DMX-200 in patients with FSGS receiving an ARB pen Label Extension >| 72 patients @ 35 weeks rt 2: Part 3: 4 Successful analysis outcom analysi
Slide 12: For personal use only
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Slide 13: Corporate overview
Corporate overview HARE PRICE Ticker Symbol ASX: DXB 7 20 Sn vito) see a os 2 Cc Cash Balance (Sep24)* $19.2 million 7 os a = ne i Panes an 1 oO Market Capitalisation? “A$201 million 3" Ww WAS ui fos 2 5 b 0 Share price! ~A$0.36 a : j= Total ordinary shares on issue? 557,866,917 je) VY Average Daily
Slide 14: For personal use only
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Slide 15: For personal use only
A biopharmaceutical company developing innovative new therapies in areas with unmet medical needs, with a core focus on inflammatory kidney diseases. > TO DELIVER AGAINST STRATEGIC PLAN Dimerix HQ 425 Smith St, Fitzroy 3065 Victoria, Australia T. 1300 813 321 E. investor@dimerix.com — @ Dimerix 6
Slide 16: For personal use only
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Slide 18: 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 19: 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 Historical lack of incentives and public policy have Icontributed to high costs and} poor health outcomes for renal patients! 2018: workshops and regulatory acceptance of
Slide 20: 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 21: Why are kidneys important? Symptoms of proteinuria
Why are kidneys important? Symptoms of proteinuria For personal use only • • • ➢
Slide 22: 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 n function is crashi
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: 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 28: 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 29: DMX-200: Phase 2 met primary and secondary endpoints
DMX-200: Phase 2 met primary and secondary endpoints Of - : . A ‘ ‘ veoh 7 Clinically meaningful outcomes achieved for patients,? with no safety issues atgre Cc ai q 12) > y reduction in —_ 6 proteinuria could yield years oO _ VK of preserved native kidney Cc iL function and delay the [e) R- gh onse
Slide 30: 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 31: 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 32: Advancing the broader pipeline
Advancing the broader pipeline Additional longer term pipeline opportunities diversify risk and potential sources of revenue DMX-200 potential label DMxX-700 for Undisclosed Opportunities expansion respiratory/renal fibrosis Potential to expand DMX-200 into other rare Preclinical studies show that D