Slide 1: FSGS Phase 2a results presentation
Dimerix FSGS Phase 2a results presentation 29 July 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
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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) Phase 2 results
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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
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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) • Healthy volunteers • Chronic Kidney Disease • Focal Segmental ➢ Pharmacokinetic, ➢ Safety and tolerability Glomerulosclerosis metabolism & safety study, with efficacy ➢ Safety and efficacy c
Slide 9: DMX-200 addresses three key mechanisms causing 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 2a DMX-200-202 ACTION for FSGS study design
For personal use only Phase 2a DMX-200-202 (ACTION for FSGS) is a Phase 2a, Double-blind, Randomised, Placebo-Controlled, Crossover Study Evaluating the Safety and Efficacy of DMX-200 in Patients with Primary Focal Segmental Glomerulosclerosis who are Receiving Irbesartan • 10 patients enrolled, 7 p
Slide 11: FSGS Phase 2a study data: Primary endpoint
FSGS Phase 2a study data: Primary endpoint 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 FSGS who are receiving irbesartan DMX-200 was generally No v
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For personal use only • Administration of DMX-200 to patients already taking a stable dose of an angiotensin receptor blocker = both receptors on the same cell are targeted simultaneously = both receptors are inhibited = supresses the inflammatory signal • Unlike other investigational drugs currentl
Slide 14: CMC NDA package suitability confirmed with FDA
For personal use only CMC NDA package suitability confirmed with FDA 14
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For personal use only Process validation ongoing GMP batch stability program ongoing Preparation for Complete finished IND submission product scale up batch manufacture 15
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For personal use only 2016 2017 2018 2019 2020 2021 Pre-IND for Chronic Kidney Current Phase 2 studies Pre-IND for FSGS Current Phase 2 IND planned Chronic Kidney Disease Phase 2a initiated for FSGS & - November studies readout for Q1 2021 Disease study completed diabetic kidney disease mid-2020 • •
Slide 17: Phase 3 FSGS study design overview
Phase 3 FSGS study design overview* (— ~~ . 7 a Screen \ Run-in DMX-200 Double-blind treatment period Follow-up DMX-200* Eligibility PA nts ena 0 2010 ARE OUTS Placebo* AN y y J First patient dosed Interim analysis for Full analysis for Final data read-out accelerated approval clinical endpoint Asse
Slide 18: DMX-200 Intellectual property and exclusivity
DMX-200 Intellectual property and exclusivity unveteteal Fropsty “US EU US EU Method of sont Method of use: FSGS orphan FSGS orphan any amagon's DMX-200 with a -_ with any ARB for any itbesartan exclusivity exclusivity kidney disease Granted patents US 9,314,450 US 10,058,555 rN US 10,525,038 Patent
Slide 19: For personal use only
For personal use only Ɨ ǂ ǂ • ǂ • * Sangameswaran K, Baradhi K; (2019) Focal Segmental Glomerulosclerosis [https://www.ncbi.nlm.nih.gov/books/NBK532272/] [Accessed 02Mar20] ^ Nephcure Kidney International (2020); Focal Segmental Glomerulosclerosis [https://nephcure.org/livingwithkidneydisease/unders
Slide 20: Competitive positioning
Competitive positioning Current FSGS studies underway: Dimerix DKD Ph2 data Complexa Dimerix Ph2 data Goldfinch FSGS Retrophin Ph2a data Pfizer Ph2a data Ph3 data Study reported as Ph2 data active, but not recruiting Q220 | 1 1 ' v Failed study * Dual acting angiotensin receptor blocker — Announced
Slide 21: Assets 100% owned by Dimerix
For personal use only Assets 100% owned by Dimerix 21
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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 23
Slide 24: DMX-200 in COVID-19 patients (REMAP-CAP)
Fin COVID-19 patients 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 directly with policymakers & public health officials for rapid implementat
Slide 25: 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 26: 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
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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 29: Assets 100% owned by Dimerix
For personal use only $ Assets 100% owned by Dimerix 29
Slide 30: End of Presentation
DIMERIX End of Presentation 425 Smith St, Fitzroy 3065 Victoria, Australia T. 1300 813 321 E. bd@dimerix.com