Slide 1: Dimerix Overview
Dimerix Overview (ASX: DXB) a phase II biotech with a scalable, proprietary platform technology March 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: Research Coverage and Share price performance
For personal use only Research Coverage Share price performance Taylor Collison 20Nov2019 Rating: Buy Price Target: A$0.51 3
Slide 4: For personal use only
For personal use only • • • • • • • 4
Slide 5: Product candidates in the pipeline, with clinical read outs expected mid-2020
For personal use only 3 product candidates in the pipeline, with 2 clinical read outs expected mid-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 2
Slide 6: Board of Directors & Management
Board of Directors & Management = 7 me Fa Jomes Williams, PhD, MBA Nina Webetor, PhD, MIP Lav, Sonia Poli, PhD Hugh Alsop BSc (Hons), MBA Hamish George, BCom, CA, Robert Shepherd, PhD : fc : ane : ‘ : uN ho Resonance, ious a 7 eth - K a tog CQrnamnante emt cauces |||) GH immuran Weth... || O Sex SoS
Slide 7: FY2020 milestones
For personal use only FY 2020 FSGS Phase 2a study 1st DMX-200 patents Diabetic Kidney Complete GMP DMX-700 added to fully recruited announced in Europe Disease Phase 2 study commercial batch pipeline Jul19 Jul19 fully recruited manufacture Oct19 Sep19 Oct19 Ongoing partnering Diabetic Kidney FSGS De
Slide 8: Introduction to DMX-200
Introduction to DMxX-200 ae
Slide 9: 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 • Twice daily, capsule administration • Inhibits activity of a cellular receptor of inflammation: CCR2 (C-C Chemokine Receptor Type 2) • Administered to patients alrea
Slide 10: Causes of kidney disease
Causes of kidney disease Chronic Kidney disease: Several causes of kidney disease: slow, gradual loss of kidney function Autoimmune disease (e.g. IgA nephropathy) Hereditary nephritis (e.g. Alports Syndrome) Sclerotic kidney disease : : : over time, inflammation (e.g. FSGS and diabetic kidney diseas
Slide 11: 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 sclerotic 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 Podoc
Slide 12: DMX-200 compares favourably to compounds currently in development
For personal use only DMX-200 compares favourably to compounds currently in development: • Strong, superior efficacy data Current standard of care (AT1R blocker) ➢ 36% reduction in proteinuria in Phase 2a ➢ Large unmet need in growing market • Known safety profile with no adverse events seen ➢ Lower
Slide 13: DMX-200
For personal use only • • DMX-200 • # Kidney Health Australia. 2018. Kidney Fast Facts. [ONLINE] Available at http://kidney.org.au/cms_uploads/docs/kidney-health- 13 australia-kidney-fast-facts-fact-sheet.pdf. [Accessed 15 Sep 2018] * Kidney Health Australia. 2018. Diabetic Kidney Disease. [ONLINE]
Slide 14: Diabetic kidney disease market
For personal use only ǂ ǂ * Alicic R, Rooney M, Tuttle K (2017) Diabetic Kidney Disease Challenges, Progress, and Possibilities, Clinical Journal of American Society of Nephrology [ONLINE Available at https://cjasn.asnjournals.org/content/12/12/2032 [Accessed 02Mar20] ǂ Technavio (2019); Global Diab
Slide 15: For personal use only
For personal use only • • # pre-genericization *2017, IQVIA † Avapro prescribing information 15 Note: pricing and reimbursement differs in EU and other territories ** Ionis, Vifor, Epigen deals in 2018
Slide 16: Focal segmental glomerulosclerosis market
For personal use only Ɨ ǂ Ɨ ǂ • ǂ • * Sangameswaran K, Baradhi K; (2019) Focal Segmental Glomerulosclerosis [ONLINE Available at //www.ncbi.nlm.nih.gov/books/NBK532272/ [Accessed 02Mar20] ^ Nephcure Kidney International (2020); Focal Segmental Glomerulosclerosis [ONLINE Available at https://nephcure
Slide 17: Orphan drug market
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 18: CMC NDA package suitability confirmed with FDA
For personal use only • f CMC NDA package suitability confirmed with FDA 18
Slide 19: 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) Healthy volunteers Chronic Kidney Disease patients ➢ pharmacokinetic and safety ➢ Safety, tolerability study, and clinical study efficacy study All study endpoints met 19
Slide 20: 2017: DMX-200 Phase 2a results summary
2017: DMX-200 Phase 2a results summary (N=27) Chronic Kidney Disease patients Primary Endpoints (“safety”) Secondary Endpoints (“efficacy signals”) * Incidence and severity of Adverse Events * The proportion of responders, defined as those participants * Clinically significant changes in the safety
Slide 21: 2017: DMX-200 Phase 2a study - diabetic sub-group
2017: DMX-200 Phase 2a study - diabetic sub-group ¢ In 2001 - Irbesartan studied in a large - ; group of type 2 diabetics Diabetic sub-group ACR mean reduction (n=10) ¢ Proteinuria levels reduced by 24% * In 2017 - DXB Phase 2a study: DMX-200 + Irbesartan In addition to irbesartan reduction, protein
Slide 22: 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 22
Slide 23: Primary and secondary endpoints
For personal use only Primary Secondary endpoint endpoints • • ➢ ➢ ➢ ➢ ➢ ➢ ➢ • 23
Slide 24: FSGS Phase 2a 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 24
Slide 25: Primary and secondary endpoints
For personal use only Primary Secondary endpoint endpoints • • 25
Slide 26: For personal use only
For personal use only • • • • • 26
Slide 27: CMC NDA package suitability confirmed with FDA
For personal use only CMC NDA package suitability confirmed with FDA 27
Slide 28: Regulatory pathway
505(b)(1) regulatory pathway For personal use only for New Chemical Entity (NCE) IND submission planned planned in Q420/Q121 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 he
Slide 29: 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 30: For personal use only
For personal use only ✓ Commercially attractive and 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 commer
Slide 31: FY2020 milestones
For personal use only FY 2020 FSGS Phase 2a study 1st DMX-200 patents Diabetic Kidney Complete GMP DMX-700 added to fully recruited announced in Europe Disease Phase 2 study commercial batch pipeline Jul19 Jul19 fully recruited manufacture Oct19 Sep19 Oct19 Ongoing partnering Diabetic Kidney FSGS De
Slide 32: End of Presentation
DIMERIX End of Presentation 425 Smith St, Fitzroy 3065 Victoria, Australia T. 1300 813 321 E. bd@dimerix.com