Dimerix Limited · ASX:DXB
Dimerix — Shareholder Meeting (November 2023)
17 slides from Dimerix's shareholder meeting presentation, Nov 21, 2023
Slide 1: Company Review
For personal use only COMPANY REVIEW DR NINA WEBSTER 1
Slide 2: Forward looking statements
Forward looking statements For personal use only 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 ma
Slide 3: Key company metrics
Key company metrics For personal use only $17.5 million proforma cash balance (incl $10.7 million upfront licensing fee) Near term Phase 3 analysis outcome announced (~15Mar241) Existing commercial partnership with continued partnering negotiations with parties outside licensed territories 426,079,8
Slide 4: Dimerix board
Dimerix board 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 (
Slide 5: Development pipeline
Development pipeline For personal use only Progra Indication Preclinical Phase 1 Phase 2 Phase 3 m Core focus Focal Segmental Glomerular Sclerosis (FSGS) DMX-200 Diabetic Kidney Disease DMX-700 Chronic Obstructive Pulmonary Disease (COPD) DMX-xxx Undisclosed (multiple) 5
Slide 6: Key achievements – FY23
Key achievements – FY23 FDA approved $230m licensing deal executed for EU, CA, ANZ brand name QYTOVRA® DSMB completed 2nd Sep 23 Oct 23 successful review of For personal use only ACTION3 trial Sep 23 $8.9 million FY23 Aug 23 R&D tax incentive received NMPA indicated Dimerix completed ACTION3 Jul 23
Slide 7: Key elements of partnership
Key elements of partnership ADVANZ PHARMA acquires exclusive license to commercialise DMX-200 in European Economic Area, Switzerland, UK, Australia, New Zealand and Canada For personal use only Dimerix to receive up to ~AU$230* million in upfront and milestone payments, plus royalties o €6.5 million
Slide 8: Global partnering availability
Global partnering availability Licensed territories (EAA, Switzerland, UK, Canada, Australia/New Zealand) – DMX-200 For personal use only Available for licensing - 8
Slide 9: FSGS market size
FSGS market size Assuming US$9,900k/month as FSGS in 7MM market For personal use only example pricing in the US size estimated to be (same pricing as sparsentan in US3bp.a IgAN)2 1 Current market specifically for FSGS does not exist FSGS Market Size Estimated diagnosed $US p.a Region patients (2022)
Slide 10: Phase 3 Update
For personal use only Phase 3 Update 10
Slide 11: What is Focal Segmental Glomerulosclerosis (FSGS)?
What is Focal Segmental Glomerulosclerosis (FSGS)? Normal glomerulus2 For personal use only • FSGS makes up approximately 10% of all kidney diseases1 • On average FSGS progresses to kidney failure within 5 years after onset of proteinuria1 • Currently no approved drugs for FSGS patients are treate
Slide 12: Competitive landscape in FSGS
Competitive landscape in FSGS DMX-200 is the only therapy in phase 3 development For personal use only Phase 1 Phase 2 Phase 3 Company DMX-200 VX-147 Vertex Pharmaceuticals BI-764198 Boehringer Ingelheim Atrasentan Chinook VAR-200 Zyversa VB119 Valenza Bio Sources: Company Documents, Statutory and R
Slide 13: DMX-200 phase 2 data is clinically meaningful
DMX-200 phase 2 data is clinically meaningful PCR reduction NKF-FDA-EMA workshop1 : For personal use only “eGFR slope reduction of 0.5–1.0 ml/min/1.73 m2/year may be associated with lower end stage kidney disease risk” Kidney survival study (2020)2: “reductions ~10% in proteinuria translated to clin
Slide 14: 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 For personal use only Part 1: 72 patients @ 35 weeks Part 2: 144 patients @ 35 weeks Part 3: 286 patients @ 104 weeks receive drug or placebo
Slide 15: Part 1 analysis set for March 2024
Part 1 analysis set for March 2024 • Announcement of Part 1 analysis of Phase 3 trial expected on, or around, 15 March 2024* For personal use only • A successful outcome would represent a clinically and statistical meaningful improvement in proteinuria vs placebo and the trial is continuing to Part
Slide 16: Investment highlights
Investment highlights Continued partnering For personal use only negotiations with parties outside licensed territories2 Lead candidate: DMX-200 in focal segmental glomerulosclerosis (FSGS) kidney disease 1. Current independent Data Monitoring Board (DSMB) meeting scheduled; 2.Offers are non-binding
Slide 17: For personal use only
For personal use only A biopharmaceutical company developing innovative new therapies in areas with unmet medical needs, with a core focus on inflammatory disease treatments such as kidney and respiratory diseases. WELL POSITIONED TO DELIVER A G A I N S T S T R AT E G I C P LA N Dimerix HQ 425 Smith