Slide 1: Biotech Partnering Showcase 2020 Conference Presentation
For Immediate Release Biotech Partnering Showcase 2020 For personal use only Conference Presentation MELBOURNE, Australia, 13 January 2020: Dimerix Limited (ASX: DXB), a clinical-stage biopharmaceutical company, is pleased to provide a copy of the presentation from the Biotech Partnering Showcase 20
Slide 2: About DMX-200 and DMX-700
DMX-200 administered to patients already taking irbesartan reduced proteinuria levels by a further 36%. This reduction in proteinuria is highly correlated with improved renal function and delay in kidney failure and dialysis. The compelling results from this study prompted the decision to initiate t
Slide 3: Dimerix Overview January 2020
Dimerix Overview January 2020 @ Dimerix
Slide 4: 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 5: For personal use only
For personal use only 1. Introduction to Dimerix 2. Receptor-HIT 3. DMX-200 in Diabetic Kidney Disease 4. DMX-200 in Focal Segmental Glomerulosclerosis (FSGS) 4. DMX-700 in Chronic Obstructive Pulmonary Disease (COPD) 5. Summary 3
Slide 6: Financial information and share price performance
For personal use only Financial information Share price performance Share price(13Jan20) A$0.145 52 week low / high A$0.072 / 0.15 Shares on issue 181.5 million Market Capitalisation A$26.3 million Cash (as at 30Sep19) A$1.98 million R&D Tax rebate received* A$1.18 million Placement funds received^
Slide 7: A pipeline of drugs identified using Receptor-HIT
A pipeline of drugs identified using Receptor-HIT Programs based on the critical scientific rationale that GPCRs act as a complex with other GPCRs and have novel pharmacology when in complex uo Dimerix Strategic Fit Dimerix is developing a commercial pipeline of drugs for G Protein-Coupled Receptors
Slide 8: For personal use only
For personal use only In pre-clinical studies Public DMX-700 in company COPD (ASX: DXB) Receptor-HIT Phase 2 in platform diabetic licensed kidney Formed in globally disease (non-exclusive) Two further 2004 on Late Phase 2 Phase 2 trials proprietary licensing underway for GPCR assay opportunity, diff
Slide 9: Product candidates in the pipeline, with clinical read outs expected in 2020
For personal use only 3 product candidates in the pipeline, with 2 clinical read outs expected in 2020 Pivotal Study Preclinical Phase 1 Phase 2 Market Compound Disease Target Focal Segmental Glomerulosclerosis Phase 2a last patient dosing June 2020 DMX-200 (FSGS) Phase 2 last patient dosing July 20
Slide 10: Introduction to Receptor-HIT
Introduction to Receptor-HlT
Slide 11: For personal use only
For personal use only • • • • Hauser, Alexander S. et al. “Pharmacogenomics of GPCR Drug Targets.” Cell 172.1-2 (2018): 41–54.e19. 9
Slide 12: Dimerix technology — Receptor-HIT
Dimerix technology — Receptor-HIT * Patented tool that enables understanding of real-time receptor interactions ° Particularly suited to GPCRs * Can identify new uses for existing drugs, deorphanize receptors, and drive the discovery of new drugs and research programs Receptor Heteromer: Macromolecu
Slide 13: For personal use only
For personal use only Ayoub, Zhang, Kelly, See, Johnstone, McCall, Williams, Kelly, Pfleger (2015) PLoS One 10:e0119803 11
Slide 14: Introduction to DMX-200
Introduction to DMxX-200 ae
Slide 15: DMX-200: a small molecule known as propagermanium
For personal use only DMX-200: a small molecule known as propagermanium for patients already receiving angiotensin receptor blockade NCE status • Twice daily, capsule administration in US and • Administered to patients already on standard of care treatment (irbesartan) Europe • Product attributes: d
Slide 16: DMX-200 addresses three key mechanisms that cause renal damage
For personal use only DMX-200 addresses three key mechanisms that causes renal damage and chronic kidney disease 1 hyperfiltration of and hypertension within blood vessels of the glomeruli 2 inflammatory cell infiltration of the kidneys: subsequent 3 fibrosis loss of specialised cells called Podocyt
Slide 17: DMX-200 compares favourably to compounds in development
For personal use only DMX-200 compares favourably to compounds currently in development: Current standard of care (AT1R blocker) • Strong, superior efficacy data ➢ Large unmet need in growing market • Known safety profile with no adverse events seen ➢ Lower risk development 15
Slide 18: Phase 1 and Phase 2a studies
For personal use only 1 x Phase 1 study (DMX-200-101) 1 x Phase 2a study (DMX-200-201) ➢ pharmacokinetic and safety ➢ Safety, tolerability study, and clinical study efficacy study 16
Slide 19: Safety and tolerability of DMX-200 with irbesartan
Safety and tolerability of DMX-200 as an adjunct therapy to For personal use only irbesartan treatment in patients with proteinuric kidney disease • • • • 17
Slide 20: DMX-200 Phase 2a study - diabetic sub-group
DMX-200 Phase 2a study - diabetic sub-group In 2001 - Irbesartan studied in a large group of type 2 diabetics ¢ Proteinuria levels reduced by 24% In 2017 - DXB Phase 2a study: DMX-200 + Irbesartan In addition to irbesartan reduction, proteinuria levels reduced by a further 36% in diabetic sub- group
Slide 21: Manufacturing and commercial supply
For personal use only ✓ USA based contract manufacturer appointed for commercial supply of API ✓ FDA approved manufacturing facility ✓ Exclusive development and methodology to manufacture API owned by Dimerix ✓ In-house capability for commercial supply of finished product ✓ Analytical methods valida
Slide 22: Regulatory pathway
505(b)(1) regulatory pathway For personal use only for New Chemical Entity (NCE) IND submission planned planned in 2020, post Phase 2 data read-out Non-clinical and CMC NDA package suitability confirmed with FDA Pre-IND meeting held with FDA November 2019 for FSGS Phase 3 plan Pre-IND meeting held w
Slide 23: Patents, IP, exclusivity and manufacturing
For personal use only Patents • • • • IP • Exclusivity • • • Manufacturing • 21
Slide 24: DMX-200 in Diabetic Kidney Disease
DMX-200 in Diabetic Kidney Disease
Slide 25: DMX-200 proposed indication for diabetic nephropathy
DMX-200 proposed indication for the treatment of diabetic nephropathy in patients with type 2 diabetes w Dimerix 23
Slide 26: Diabetic Kidney Disease
For personal use only Diabetic Kidney Disease • Also known as Diabetic Nephropathy • 23 million diagnosed diabetics in the US* • Dialysis costs of ~$100,000/patient/year¥ ➢ 36.5% of these had kidney disease* ➢ ~8.3 million with Diabetic Kidney Disease in the US alone • Dialysis severely affects qual
Slide 27: For personal use only
For personal use only *2017, IQVIA 25 Note: pricing and reimbursement differs in EU and other territories
Slide 28: Phase 2 DMX-200-203 (ACTION for DKD)
For personal use only Phase 2 DMX-200-203 (ACTION for DKD)- A Phase 2, Double-blind, Randomised, Placebo-Controlled, Crossover Study Evaluating the Safety and Efficacy of Propagermanium in Patients with Diabetic Kidney Disease (DKD) who are Receiving Irbesartan • N=40 (45 patients dosed). Primary en
Slide 29: 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 Last patient dosing scheduled July 2020 27
Slide 30: Primary and secondary endpoints
For personal use only Primary Secondary endpoint endpoints • • ➢ ➢ ➢ ➢ ➢ ➢ ➢ • 28
Slide 31: 2019 to 2020: continue progress with licensing partner
For personal use only 2019 Continue progress 2020 with licensing partner 29
Slide 32: For personal use only
For personal use only ✓ DKD is a large & growing market ✓ Unmet need, with low competition ✓ Granted patents with additional patents pending ✓ Strong existing Phase 2a data demonstrating superior efficacy ✓ Existing long-term safety data available ▪ Reduced risk and development program ✓ Product sup
Slide 33: Introduction to DMX-200 in FSGS
Introduction to DMX-200 in FSGS
Slide 34: DMX-200 proposed indication for FSGS
DMX-200 proposed indication for the treatment of focal segmental glomerulosclerosis w Dimerix 32
Slide 35: Focal Segmental Glomerulosclerosis
For personal use only Focal Segmental Glomerulosclerosis • A serious and rare kidney disease: orphan indication • Rapid progression to end-stage renal disease • Dialysis costs of ~$100,000/patient/year • ~210,000 individuals globally • Eventually require blood dialysis • Dialysis severely affects qu
Slide 36: For personal use only
For personal use only ǂ # Transparency Market Research, 2018, Focal Segmental Glomerulosclerosis (FSGS) Market, Global Industry Analysis, Size, Share, Growth, Trends, & Forecast 2017-2025, [ONLINE] Available at: https://www.transparencymarketresearch.com/focal-segmental-glomerulosclerosis-market.htm
Slide 37: Phase 2a DMX-200-202 (ACTION for FSGS)
For personal use only Phase 2a DMX-200-202 (ACTION for FSGS)- A Phase 2a, Double-blind, Randomised, Placebo-Controlled, Crossover Study Evaluating the Safety and Efficacy of Propagermanium in Patients with Primary Focal Segmental Glomerulosclerosis who are Receiving Irbesartan • N=10. Primary endpoi
Slide 38: Study design
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 36
Slide 39: Primary and secondary endpoints
For personal use only Primary Secondary endpoint endpoints • • 37
Slide 40: 2019 to 2020: continue progress with licensing partner
For personal use only 2019 Continue progress 2020 with licensing partner 38
Slide 41: For personal use only
For personal use only ✓ FSGS is a small but growing market ✓ Orphan status with FDA and EMA ✓ Unmet need, with no current competition ✓ Granted patents with additional patents pending ✓ Existing long-term safety data available ▪ Reduced risk and development program ✓ Product supply at commercial sca
Slide 42: Introduction to DMX-700 in COPD
Introduction to DMX-700 in COPD
Slide 43: DMX-700 in Chronic Obstructive Pulmonary Disease (COPD)
For personal use only DMX-700 in Chronic Obstructive Pulmonary Disease (COPD) Progressive & life- threatening lung disease affecting individuals of all ages caused by: tobacco smoke, air pollution, occupational dust/fumes, long-term asthma COPD limits pulmonary airflow that is not fully reversible U
Slide 44: COPD market and global initiatives
For personal use only Global Initiatives Global COPD • World Health Organization (WHO) treatment market No candidates in • COPD Foundation US$14 billion (2017) & projected to late stage • American Thoracic Society increase at CAGR development • Centers for Disease Control & Prevention (CDC) >4% to 2
Slide 45: Introducing DMX-700 for COPD
Introducing DMX-700 for COPD * DMX-700 for the treatment of COPD by blocking heteromer signalling in receptors active in COPD ¢ Initial studies on the receptor pair have been conducted under an Innovation Connections grant awarded to Dimerix in November 2018 * The two molecules working together, eac
Slide 46: For personal use only
For personal use only cell cell cell cell 44
Slide 47: DMX-700 pre-clinical data
DMX-700 pre-clinical data When both Receptor ligands administered More than additive signal observed 0.64 b Ww Fa B 0.44 When only Receptor 2 2 ligand administered: 3 A = © Both ligands larger signal observed = © A Ligand2 Da a 024 Ligand 1 When only Receptor 1 ligand administered: 0.0~ T T signal o
Slide 48: End of Presentation
DIMERIX End of Presentation