Dimerix Limited · ASX:DXB
Dimerix — Investor Presentation (March 2024)
33 slides from Dimerix's investor presentation, Mar 5, 2024
Slide 1: Investor Presentation March 2024
@w Dimerix (ASX:DXB) € CdDeveloping new therapies to treat inflammatory causes of axidney and respiratory disease with unmet clinical needs —— © Cc : je) a : 5 ©: © e > March 2024 ACTICINS [e) . 56S CLINICAL STUDY i Investor Presentation Authorised for lodgement by the Board of the Company
Slide 2: Forward looking statements
? Forward looking Onal use only : his presentation includes forward-looking statements that are subject to risks and uncertainties. Such statements involve known and unknown ris! Gra important factors that may cause the actual results, performance or achievements of Dimerix to be materially differen
Slide 3: Lead Drug Candidate, Indication, Market, Milestones
Lead Drug Candidate For personal use only • • Lead Indication • • • Market Opportunity • • • Commercial Validation • • Upcoming Milestones • •
Slide 4: What is FSGS? Why are kidneys important?
For personal use only What is FSGS? Why are kidneys important? Why is proteinuria important?
Slide 5: FSGS causes and prognosis
FSGS causes and prognosis Focal segmental glomerulosclerosis (FSGS) is one of the most common forms of acquired glomerular disease leading to end stage kidney disease (ESKD), requiring dialysis or transplant Caused by a variety of conditions - primary FSGS, genetic FSGS, FSGS of unknown cause and se
Slide 6: Progression of FSGS kidney disease
Progression of FSGS kidney disease For personal use only Existing blood pressure medication targets Step 1: angiotensin receptor blocker (ARB) lowers blood pressure N Less kidney cells cause further hyperfiltration and inflammation Kidney vessels have to work harderunder highypressure 1 DMX-200 inte
Slide 7: DMX-200: Phase 2 met primary and secondary endpoints
DMX-200: Phase 2 met primary and secondary endpoints >f Clinically meaningful outcomes achieved for patients, with no safety issues Cc Average reduction of 17% in proteinuria after 16 a treatment on DMX-200 versus placebo! ONN 0.0% © 5.0% Cc oO K-00: EFFICACY a: (<b) a” a * 86% of patients lon £ 200
Slide 8: DMX-200: Phase 2 met primary and secondary endpoints
DMX-200: Phase 2 met primary and secondary endpoints >f 17% average reduction of proteinuria in Phase 2 is clinically meaningful! EUROPEAN MEDICINES AGENCY Estimated eGFR TENCE MEDICINES 1 om Adjusted models fo) ; slope year year uPCR reduction (@5%Cl FDA & EMA recognise surrogate o Persistent prote
Slide 9: Phase 3 Clinical Trial
PHASE 3 CLINICAL TRIAL For personal use only @ Dimerix
Slide 10: Background, Phase 3 Trial, Timeline
For personal use only Background Phase 3 Trial Timeline • • •
Slide 11: ACTION3 Phase 3 clinical trial
O ACTIGN3 Phase 3 clinical trial FSGS CLINICAL STUDY 2 Cc (o) o Yn =) © Cc ie) i) — o fol Oana LI imminently* Part 1: Part 2: analysis outcome analysis outcome final analysis Part 3: ARB + placebo 144 patients @ Total of 286 patients} 72 patients @ << - - - 35 weeks @ 104 weeks 35 weeks (uPCR) (uPCR
Slide 12: Competitive landscape in FSGS
Competitive landscape in FSGS No approved therapies for FSGS i?) Phase 1 Phase 2 Phase 3 Company & pi76a98 Boehringer Ingelheim nn nnn nnsnunnnnnsansnosssnunnsnasunonesninssunnonsssnonessnsuunsennssnnnnn © Atrasentan Chinook @ Dimerix
Slide 13: Benefits of Targeting Orphan Diseases
For personal use only Benefits of Targeting Orphan Diseases • • • • • • •
Slide 14: Market Capitalisation
$3,500 For personal use only • $3,000 • $2,500 Market Capitalisation ($millions) ▪ $2,000 ▪ ▪ $1,500 ▪ $1,000 • $500 $- Feb-19 Feb-20 Feb-21 Feb-22 Feb-23 Feb-24
Slide 15: Potential FSGS market size
Potential FSGS market size XB is targeting multi-billion dollar kets with A Estimated 7MM (+China) diagnosed patients (2022)'4 >303,000 patients For personal use only Europe/UK (licensed) 85,014 Y Example pricing for other rare kidney disease drugs : * in the US (i.e. Filspari in IgAN)?is US$9,900 p
Slide 16: Licensing deal - ADVANZ partnership
Licensing deal - ADVA\NZ partnership ADVANZ PHARMA acquires exclusive license to commercialise DMX- 200 in EEA, Switzerland, UK, Australia, New Zealand and Canada PHARMA AU$230+ million licensing deal Control Retained Rights to other jurisdictions Dimerix to receive up to “AU$230* million in upfront
Slide 17: Global partnering availability
Global partnering availability For personal use [HBB Licensed territories (EAA, Switzerland, UK, Canada, ANZ) - DMX-200 + Advanz Partnership marked the first of many potential agreements globally + Partnering negotiations remain on-going in other territories + Potential multi-billion dollar markets
Slide 18: Lead Drug Candidate, Indication, Market, Milestones
Lead Drug Candidate For personal use only • • Lead Indication • • • Market Opportunity • • • Commercial Validation • • Upcoming Milestones • •
Slide 19: Appendices
For personal use only IMerlx Appendices WELL POSITIONED TO DELIVER AGAINST STRATEGIC PLAN SCAN ME Dimerix HQ 425 Smith St, Fitzroy 3065 Victoria, Australia T. 1300 813 321 E. investor@dimerix.com
Slide 20: Corporate overview
Corporate overview SHARE PRICE 0.3 50 For personal use only 45 T icker Symbol ASX:DXB 0.25 40 � '< < 35 � � 0.2 "' 3 "' 30 0,� {; Cash Balance (Dec23) NA$14.8 million �a, 0.15 "' a. a. 25 0 :, ·g_ 3 :ll 20 � _g [ o 0.1 15 3 E Market Capitalisation NA$100 million 10 0 f 0.05 .U��l� L .J l 5 _.___._ _
Slide 21: Board of Directors
For personal use only Mark Diamond Nina Webster Hugh Alsop Sonia Poli Clinton Snow BSc, MBA PhD, MBA, M.IP.Law BSc (Hons), MBA PhD BEng (Hons), BCom Non-Executive Chairman CEO & Managing Director Non-Executive Director Non-Executive Director Non-Executive Director Antisense, Faulding (Pfizer) Acrux,
Slide 22: Management team
For personal use only Nina Webster Hamish George David Fuller Robert Shepherd Bronwyn Pollock PhD, MBA, M.IP.Law BCom, CA, GIA(Cert) B.Pharm (Hons), MBBS PhD MBA BSc (Hons), MBA CEO & Managing Director CFO & Company Secretary CMO CCO VP, Product Development Wyeth (Pfizer), Acrux, Immuron Bio101, Pit
Slide 23: For personal use only
For personal use only • • • • • • • • •
Slide 24: 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 |contributed to high costs and| poor health outcomes for renal patients! 2018: workshops and regulatory acceptance of
Slide 25: Clinical study change: use of surrogate endpoints
Clinical study change: use of surrogate endpoints ACTING A surrogate endpoint is an intermediate outcome FSGS CLINICAL STUDY which substitutes the clinically meaningful endpoint Cc je) ® 2) a) © Cc je) yY) — ®o a FDA grants first accelerated approval a drug based on Publications proteinuria endpoint
Slide 26: Upfront payments in rare kidney disease licensing deals
$90 use only $80 Ventus+ Novo Nordisk (Worldwide) Ph 1, multiple assets $70 Travere Therapeutics +Vifor Pharma (EU, UK, ANZ) Ph 3, multiple indications $60 Roche +Ionis Pharmaceuticals Aurinia Pharmaceuticals + (Worldwide) Ph3, single asset Upfront payment (US$) Otsuka Pharmaceutical (EU, Japan, Rus
Slide 27: Policy change: renal disease healthcare economic burden
Policy change: renal disease healthcare economic burden > a i ro “40 million | adults have kidney [e) ; disease ("15% of the . . . . adult population) in the | Economic cost of kidney failure in the US i 1 Total Medicare expenses per year costs for kidney failure patients (2009-2021E) ? US in 2021 $
Slide 28: DMX-200 working on inflammatory signalling pathway
DMX-200 — working on inflammatory signalling pathway CCR2 inhibitor working synergistically alongside the current standard of care (AT1R blocker): G protein-coupled receptor (GPCR) only fo) 12) =) © New Chemical Entity status, 2 x 120mg capsule daily Consistently safe and well 4 clinical studies com
Slide 29: For personal use only
For personal use only • • • Proposed non-clinical safety package suitability for NDA confirmed with FDA
Slide 30: For personal use only
For personal use only uMCR normalised to baseline v time N=7, GeoMean 50% 1.5 uMCR normalised 0% 1.0 -50% 0.5 On placebo On active 0.0 0 5 10 15 Time (weeks) • ▪ ▪
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 Ys any endothelin A receptor for any disease NCE status? exclu
Slide 32: Development pipeline
Development pipeline Program Indication Core focus { Focal Segmental Glomerular Sclerosis (FSGS) DMX-200 Diabetic Kidney Disease DMX-700 Chronic Obstructive Pulmonary Disease (COPD) DMX-xxx Undisclosed (multiple) For personal use only
Slide 33: Advancing the broader pipeline
Advancing the broader pipeline Additional longer term pipeline opportunities diversify risk and potential sources of revenue DMX-700 for Chronic DMX-200 for Diabetic Undisclosed Opportunities Obstructive Pulmonary Kidney Disease Disease (COPD) Preclinical studies show that DMX-700 Phase 2 demonstrat