drugset / Press release

Investor Presentation

2020-03-09 · Dimerix Bioscience Pty Ltd · original dimerix.com ↗

2 3 Share price performanceResearch Coverage Taylor Collison 20Nov2019 Rating: Buy Price Target: A$0.51 4 • • • • • • • 5 Compound Disease Target Preclinical Phase 1 Phase 2 Pivotal Study Market DMX-200 Focal Segmental Glomerulosclerosis (FSGS) DMX-200 Diabetic Kidney Disease DMX-700 Chronic Obstructive Pulmonary Disease (COPD) DMX-XXX Undisclosed (various) Phase 2a last patient dosing June 2020 Phase 2 last patient dosing July 2020 3 product candidates in the pipeline, with 2 clinical read outs expected mid-2020 6 7 FY 2020 FSGS Phase 2a study fully recruited Jul19 1st DMX-200 patents announced in Europe Jul19 Diabetic Kidney Disease Phase 2 data Mid-2020 FSGS phase 2 data Mid-2020 Develop Dimerix pipeline Generate strong investor returns Diabetic Kidney Disease Phase 2 study fully recruited Sep19 Complete GMP commercial batch manufacture Oct19 Communicate with FDA Nov19 2nd Innovation Connections Grant awarded Oct19 Ongoing partnering activities and discussions DMX-700 proof of concept DMX-200 IND submission DMX-700 pre-IND submission Beyond FY2020 Secure a licensing agreement DMX-700 added to pipeline Oct19 9 *NCE can attract 5 years exclusivity in US and EU (7 years in US and 10 years in EU for Orphan Drugs) 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 already on standard of care treatment (angiotensin receptor blocker) • Product attributes: deliver best-in-class benefits to patients • Never been approved by a regulatory authority in the US, Europe or Australia o DMX-200 is a New Chemical Entity* (NCE) 10 11 DMX-200 addresses three key mechanisms that causes renal damage and sclerotic kidney disease 3 loss of specialised cells called Podocytes (cannot regenerate) from the glomeruli 2 inflammatory cell infiltration of the kidneys: subsequent fibrosis 1 hyperfiltration of and hypertension within blood vessels of the glomeruli 12 Current standard of care (AT1R blocker) ➢ Large unmet need in growing market DMX-200 compares favourably to compounds currently in development: • Strong, superior efficacy data ➢ 36% reduction in proteinuria in Phase 2a • Known safety profile with no adverse events seen ➢ Lower risk development 13 # Kidney Health Australia. 2018. Kidney Fast Facts. [ONLINE] Available at http://kidney.org.au/cms_uploads/docs/kidney -health- australia-kidney-fast-facts-fact-sheet.pdf. [Accessed 15 Sep 2018] * Kidney Health Australia. 2018. Diabetic Kidney Disease. [ONLINE] Available at https://kidney.org.au/cms_uploads/docs/diabetic -kidney-disease--kidney-health-australia-fact-sheet.pdf [Accessed 11Sep18] • • • DMX-200 14 * Alicic R, Rooney M, Tuttle K (2017) Diabetic Kidney Disease Challenges, Progress, and Possibilities, Clinical Journal of American So ciety of Nephrology [ONLINE Available at https://cjasn.asnjournals.org/content/12/12/2032 [Accessed 02Mar20] ǂ Technavio (2019); Global Diabetic Nephropathy Market 2018 -2022 [ONLINE Available at https://www.businesswire.com/news/home/20181227005118 /en/Global-Diabetic-Nephropathy-Market-2018-2022-34-CAGR [Accessed 02Mar20] ^ Market Research Future (2020); Diabetic Neuropathy Treatment Market Research Report – Global Forecast to 2025 [ONLINE Available at https://www.marketresearchfuture.com/reports/diabetic -neuropathy-treatment-market-8359 [Accessed 02Mar20] ǂ ǂ 15 # pre-genericization *2017, IQVIA † Avapro prescribing information ** Ionis, Vifor, Epigen deals in 2018 • • Note: pricing and reimbursement differs in EU and other territories 16 * 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.org/livingwithkidneydis ease/understanding-glomerular-disease/understanding -fsgs/ [Accessed 02Mar20] ǂ Rosenberg A, Kopp J (2017); Focal Segmental Glomerulosclerosis, Clinical Journal of American Society of Nephrology [ONLINE Av ailable at https://cjasn.asnjournals.org/content/12/3/502 [Accessed 02Mar20] Ɨ DelveInsight Market Research Report (2020); Focal Segmental Glomerulosclerosis (FSGS) - Market Insight, Epidemiology and Market Forecast -2030 # Transparency Market Research (2019); Focal Segmental Glomerulosclerosis (FSGS) Market [ONLINE Available at https://www.transp arencymarketresearch.com/focal -segmental-glomerulosclerosis -market.html [Accessed 02Mar20) ǂ Ɨ Ɨ ǂ • • ǂ 17 # 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.html [accessed 21Nov18) *2018, IQVIA , Orphan Drugs in the United States: Growth Trends in Rare Disease Treatments, [ONLINE] Available at: https://www.iqvia.com/ -/media/iqvia/pdfs/institute-reports/orphan-drugs-in-the-united- states-growth-trends-in-rare-disease-treatments.pdf [accessed 19Jun19] ǂ2018, IQVIA , Orphan Drugs in the United States: Exclusivity, Pricing and Treated Populations, [ONLINE] Available at: https://www.iqvia.com /-/media/iqvia/pdfs/institute -reports/orphan-drugs-in-the-united- states-exclusivity-pricing-and-treated-populations.pdf [accessed 19Jun19] ǂ 18 •   f  CMC NDA package suitability confirmed with FDA 19 1 x Phase 2a study (DMX-200-201) Chronic Kidney Disease patients ➢ Safety, tolerability study, and efficacy study 1 x Phase 1 study (DMX-200-101) Healthy volunteers ➢ pharmacokinetic and safety clinical study All study endpoints met 20 • • • • 21 • • • 22 • Study period 1 12 weeks Washout 6 weeks Study Period 2 12 weeks Results Group 1 (n=20) DMX-200 Placebo Group 2 (n=20) Placebo DMX-200 Irbesartan 300mg 23 • • ➢ ➢ ➢ ➢ ➢ ➢ ➢ • Primary endpoint Secondary endpoints 24 Study period 1 16 weeks Washout 6 weeks Study Period 2 16 weeks Results Group 1 (n=5) DMX-200 Placebo Group 2 (n=5) Placebo DMX-200 Irbesartan 300mg • 25 • • Primary endpoint Secondary endpoints 26 • • • • • 27 CMC NDA package suitability confirmed with FDA 28 Pre-IND meeting held with FDA in 2016 for Chronic Kidney Disease IND submission planned in Q420/Q121 post Phase 2 data read-out 505(b)(1) regulatory pathway for New Chemical Entity (NCE) planned Pre-IND meeting held with FDA November 2019 for FSGS Phase 3 plan Non-clinical and CMC NDA package suitability confirmed with FDA 29 30 ✓ 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 commercial scale secured ✓ Phase 2 data expected mid-2020 ✓ FDA confirmed non-clinical and CMC NDA package suitability and phase 3 study design principles ✓ DMX-200 approved for compassionate use in Australia following physician recommendation 31 FY 2020 FSGS Phase 2a study fully recruited Jul19 1st DMX-200 patents announced in Europe Jul19 Diabetic Kidney Disease Phase 2 data Mid-2020 FSGS phase 2 data Mid-2020 Develop Dimerix pipeline Generate strong investor returns Diabetic Kidney Disease Phase 2 study fully recruited Sep19 Complete GMP commercial batch manufacture Oct19 Communicate with FDA Nov19 2nd Innovation Connections Grant awarded Oct19 Ongoing partnering activities and discussions DMX-700 proof of concept DMX-200 IND submission DMX-700 pre-IND submission Beyond FY2020 Secure a licensing agreement DMX-700 added to pipeline Oct19

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