Slide 1: Diabetic Kidney Disease Phase 2 Study Results Presentation
Dimerix Diabetic Kidney Disease Phase 2 Study Results Presentation 14 September 2020
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 risks and important factors that may cause the actual results, performance or achievements of Dimerix to be materially different fro
Slide 3: For personal use only
For personal use only • • • • ➢ ➢ 3
Slide 4: Top shareholders and share price performance
For personal use only Top 10 shareholders Share price performance 4 *June 2020 quarter
Slide 5: Product candidates in the pipeline
For personal use only 4 product candidates in the pipeline, with 3 clinical opportunities Pivotal Study Preclinical Phase 2 Phase 1 Market Compound Disease Target Acute Respiratory Distress Syndrome DMX-200 (ARDS) in COVID-19 patients Focal Segmental Glomerulosclerosis DMX-200 (FSGS) DMX-200 Diabeti
Slide 6: Board and management team
For personal use only James Williams Nina Webster Hugh Alsop Sonia Poli Robert Shepherd Bronwyn Pollock PhD, MBA PhD, MBA, M.IP.Law BSc (Hons), MBA PhD PhD BSc (Hons), MBA Non-Executive Chairman CEO & Managing Director Non-Executive Director Non-Executive Director R & D Director Product Development
Slide 7: For personal use only
For personal use only • • • • ➢ ➢ 7
Slide 8: DMX-200 clinical studies
For personal use only Phase 1 study (DMX-200-101) Phase 2a study (DMX-200-201) Phase 2a study (DMX-200-202) Phase 2 study (DMX-200-203) • Healthy volunteers • Chronic Kidney Disease • Focal Segmental • Diabetic kidney disease ➢ Pharmacokinetic, ➢ Safety and tolerability Glomerulosclerosis ➢ Efficacy
Slide 9: DMX-200 addresses three key mechanisms of renal damage
For personal use only DMX-200 addresses three key mechanisms that cause renal damage and sclerotic kidney disease Hyperfiltration of and hypertension within blood vessels of the glomeruli Inflammatory cell infiltration of the kidneys: subsequent fibrosis Loss of specialised cells called Podocytes (c
Slide 10: Phase 2 study design
For personal use only • • • • Study period 1 Washout Study Period 2 12 weeks 6 weeks 12 weeks Results Group 1 (n=20) DMX-200 Placebo Group 2 (n=20) Placebo DMX-200 Irbesartan 300mg 10
Slide 11: Patients with diabetic kidney disease
For personal use only Patients with diabetic kidney disease 40 Randomisation • • • • 11
Slide 12: Efficacy results: albuminuria reduction
Starting albuminuria >57mg/mmol (500mg/g) Placebo adjusted % change from baseline in albuminuria (%ACR) Frequency of patients with a albuminuria reduction (ACR) Frequency of patients with >25% albuminuria reduction (ACR) Regardless of any relationship between treatment effect and other factors: DMX-
Slide 13: Phase 2 secondary endpoint: safety data
Phase 2 study secondary endpoint: safety data afety . As measured by the number and severity of adverse events and clinically significant changes in the patient ) safety profile with the use of DMX-200 compared to placebo in participants with diabetic kidney disease who are receiving irbesartan DMX-
Slide 14: CMC NDA package suitability confirmed with FDA
For personal use only CMC NDA package suitability confirmed with FDA 14
Slide 15: Regulatory and development timeline
For personal use only 2016 2017 2018 2019 2020 Pre-IND for Chronic Kidney Current Phase 2 studies Pre-IND for FSGS Current Phase 2 Development Chronic Kidney Disease Phase 2a initiated for FSGS & - November studies readout plan scoped Disease study completed diabetic kidney disease • • 15
Slide 16: DMX-200 intellectual property and exclusivity
DMX-200 Intellectual property and exclusivity Intellectual Property “US EU Method of use: any CCR2 antagonist with any ARB for any kidney disease Granted patents* US 9,314,450 US 10,058,555 ti] US 10,525,038 Patent applications with alternative claims filed @w Dimerix Method of use: DMX-200 with irb
Slide 17: Market references
For personal use only ǂ * Alicic R, Rooney M, Tuttle K (2017) Diabetic Kidney Disease Challenges, Progress, and Possibilities, Clinical Journal of American Society of Nephrology [https://cjasn.asnjournals.org/content/12/12/2032] [Accessed 02Mar20] ǂ Technavio (2019); Global Diabetic Nephropathy Mark
Slide 18: Assets 100% owned by Dimerix
For personal use only Assets 100% owned by Dimerix 18
Slide 19: For personal use only
For personal use only
Slide 20: Randomised placebo-controlled crossover study (FSGS)
A double-blind, Randomised, Placebo-Controlled, Crossover Study For personal use only Study period 1 Washout Study Period 2 16 weeks 6 weeks 16 weeks Results Group 1 (n=5) DMX-200 Placebo • Group 2 (n=5) Placebo DMX-200 Irbesartan 300mg • • 20
Slide 21: ARDS in COVID-19 patients: REMAP-CAP
Acute Respiratory Distress Syndrome (ARDS) COVID-19 patients — awarded $1 millio AUS Governme P-CAP REMAP-CAP: global WHO. endorsed clinical study; >200 clinical sites in 16 countries* REMAP-CAP has been designated by the WHO asa Pandemic Special Study* translation of clinical trial results occur di
Slide 22: Pre-Clinical: DMX-700 in COPD
Pre-Clinical: DMX-700 in COPD DMX-700 for the treatment of COPD by blocking heteromer signalling in receptors active in COPD Initial studies shown interaction of key receptors in pathogenic biased signalling In vitro program to identify existing clinical-stage compounds capable of altering signallin
Slide 23: Dimerix technology platform: Receptor-HIT
Dimerix technology platform — Receptor-HIT * Patented multiple configurations of a Bioluminescence Resonance Energy Transfer (BRET) assay that enables understanding of real-time receptor heteromer interactions ° Particularly suited to GPCRs * Can identify new uses for existing drugs, deorphanize rec
Slide 24: For personal use only
For personal use only
Slide 25: Milestones and upcoming catalysts
For personal use only FY 2020 FSGS Phase 2a study 1st DMX-200 patents Diabetic Kidney Complete GMP DMX-700 added to 2nd Innovation Connections fully recruited announced in Europe Disease Phase 2 study commercial batch pipeline Grant awarded Jul19 Jul19 fully recruited manufacture Oct19 Oct19 Sep19 O
Slide 26: Assets 100% owned by Dimerix
For personal use only $ Assets 100% owned by Dimerix 26
Slide 27: End of Presentation
DIMERIX End of Presentation 425 Smith St, Fitzroy 3065 Victoria, Australia T. 1300 813 321 E. bd@dimerix.com