Dimerix Limited · ASX:DXB
Dimerix — Investor Presentation (March 2021)
37 slides from Dimerix's investor presentation, Mar 29, 2021
Slide 1: Investor Presentation March 2021
Dimerix Investor Presentation March 2021 @ Dimerix
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: About Dimerix
About Dimerix Multiple late-stage clinical programs in renal and respiratory disease Public company (ASX: DXB) Commercial manufacturing established for DMX-200 Additional earlier stage programs from discovery engine near term oppo DMX-200: renal Lead Phase 3 program in orphan renal condition with Ac
Slide 4: Top shareholders
For personal use only Top shareholders 4
Slide 5: Product candidates in the pipeline
5 product candidates in the pipeline, with 4 clinical opportunities For personal use only Phase 3 Study Preclinical Phase 2 Phase 1 Pivotal/ Market Compound Disease Target Focal Segmental Glomerulosclerosis DMX-200 (FSGS) Acute Respiratory Distress Syndrome DMX-200 (ARDS) in COVID-19 patients (REMAP
Slide 6: Three near term value propositions
Three near term value propositions ©oeooocuUcCPWUCMWOCCOCCO OC O88 8 C6 C6 Od 2021 2022 2024 CLARITY PHASE 3 COVID-19 4 STUDY (Respiratory Complications) Primary endpoint Potential emergency use REMAP-CAP PHASE 3 Ym COVID-19 STUDY (COVID-19 pneumonia) Primary endpoint Potential emergency use 26 Week
Slide 7: For personal use only
For personal use only • • Strong public health interest, allowing for emergency use provisions 7
Slide 8: For personal use only
For personal use only Funded by European Union through H2020 “Rapid European COVID-19 Emergency Research response” (RECOVER) project Regulatory dossiers submitted in key European countries and UK 8
Slide 9: CLARITY 2.0 primary endpoint
CLARITY 2.0 primary endpoint at day 14 + Not hospitalised, no limitations on activities + Not hospitalised, limitation on activities + Hospitalised, not requiring supplemental oxygen Prospective, multi-centre, randomised, double blind, placebo-controlled study in 600 patients in India i. To assess s
Slide 10: COVID-19 and pneumonia market potential
COVID-19 and pneumonia market potential What is Community Acquired Pneumonia (CAP)? * Pneumonia is an acute inflammation of the lungs, caused by an infection by bacteria, viruses, or fungi * COVID-19 pneumonia is cause by SARS-CoV-2 Facts and Figures 8 yo’ ICOVID-19 fsa eS BS $17 billion 2.8 million
Slide 11: FSGS phase 3 study primary endpoint
FSGS phase 3 study primary endpoint A randomised, double-blind, multi-centre, placebo-controlled study of renal outcomes of DMX-200 in patients with primary FSGS receiving an ARB Single, seamless Phase 3 study design* Study period 1 Study period 2 n=68 n=120-180 26 weeks 35 weeks* 52 weeks Group 1 D
Slide 12: Why FSGS: unmet need and market potential
Why FSGS: unmet need and market potential FSGS: rare kidney disease characterized by inflammation and scarring of the kidney’s filtration units, affecting children and adults 210,000 FSGS sufferers ; : ; ; ; ; globally* Renal failure in <5 years from diagnosis — dialysis or transplant 80,500 estimat
Slide 13: For personal use only
• • • • For personal use only • 13
Slide 14: Kidney asset transactions by clinical phase
Kidney asset transactions by clinical phase Kidney assets are in active M&A space, including: Preclinical Phase 1 Phase 2 Phase 3 Goldfinch to ji Epigen to Gilead lonis to Ghia Nae Ewe Cara to Cara to Company Technologies to Therapeutics to} Biomedica to . 7 Novo Nordisk Goldfinch to complete AstraZ
Slide 15: Additional asset value propositions
Additional asset value propositions Longer term opportunities Diabetic Kidney Disease Chronic Obstructive Pulmonary Disease Diversifying risk and potential sources of revenue COPD Global COPD treatment market (2017) US$14 billion Addressable market US$1.1 billion Key driver is the rise in diabetes g
Slide 16: Milestones and upcoming catalysts
For personal use only Special Access Scheme Global REMAP-CAP FSGS $1million grant awarded Diabetic Kidney Commercial scale DMX-700 in vitro 2nd Phase 3 COVID study additional patients phase 3 COVID study phase 2 data for ARDS in COVID-19 Disease Phase 2 data manufacturing proof of concept contracted
Slide 17: End of Presentation
DIMERIX End of Presentation 425 Smith St, Fitzroy 3065 Victoria, Australia T. 1300 813 321 E. bd@dimerix.com
Slide 18: Additional Supporting Materials
Additional Supporting Materials
Slide 19: Management and board
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 20: Scientific advisory board
For personal use only Professor Hiddo Heerspink Professor Alessia Fornoni Professor Jonathan Barratt Associate Professor Lesley Inker Dr Muh Geot Wong PhD MD, PhD, FASN MD, PhD, FRCP MD, MS, FRCPC MBBS, PhD, FRCP Chairman Member Member Member Member 20
Slide 21: For personal use only
For personal use only • • • • • 21
Slide 22: DMX-200 addresses three key mechanisms of renal damage
DMX-200 addresses three key mechanisms that causes renal damage and sclerotic kidney disease For personal use only • 1 hyperfiltration of and o hypertension within blood vessels of the glomeruli 2 o inflammatory cell infiltration of the • kidneys: subsequent fibrosis 3 loss of specialised cells call
Slide 23: DMX-200 Phase 1 and Phase 2 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 24: Phase 2a DMX-200-202 (ACTION for FSGS)
For personal use only Phase 2a DMX-200-202 (ACTION for FSGS): 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 patie
Slide 25: For personal use only
For personal use only • • • o o o 25
Slide 26: uMCR normalised to baseline over time
For personal use only uMCR normalised to baseline v time N=7, GeoMean 50% 1.5 uMCR normalised 0% 1.0 -50% 0.5 On placebo On active 0.0 0 5 10 15 Time (weeks) • ▪ ▪ 26
Slide 27: Medical Advisory Board Recommendation
Medical Advisory Board Recommendation “The positive signals suggest that treatment with DMX-200 may indeed result in clinically meaningful improvements in kidney function when added to the standard of care in patients with FSGS” “The study achieved encouraging data to support the ongoing development
Slide 28: DMX-200 development timeline
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 FSGS Chronic Kidney Disease Phase 2a initiated for FSGS & - November studies readout; planned for H1 Disease study completed diabetic kidney disease dialogue wi
Slide 29: 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 30: Phase 2 trial in diabetic kidney disease data
Phase 2 trial in diabetic kidney disease data DMxX-200 demonstrated clear benefit to patients with diabetic kidney disease in the Phase 2 clinical study Across the entire cohort (n=40) e 30% of all patients ended the study below albuminuria threshold for diabetic kidney disease diagnosis (<30mg/mmol
Slide 31: Kidney asset transactions by clinical phase
Kidney asset transactions by clinical phase Kidney assets are in active M&A space, including: Company Year Structure Upfront (US$) Milestones (US$) Royalties Preclinical Epigen to Novo Nordisk May-18 licensing undisclosed $200m undisclosed Goldfinch to Gilead (Goldfinch to complete development) May-
Slide 32: For personal use only
For personal use only
Slide 33: FSGS references
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 34: Diabetic kidney disease references
For personal use only ǂ * Reported 14 Sep2020 ** 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 Di
Slide 35: ARDS in COVID-19 patients: REMAP-CAP
Acute Respiratory Distress Syndrome (ARDS) COVID-19 patients — awarded A$1 million from AUS Government E REMAP-CAP REMAP-CAP: global clinical REMAP-CAP/COVID-19 study >18,403,737 active COVID Remdesivir Emergency Use study in COVID-19 pneumonia; protocol includes cases globally; >600,000 new Approva
Slide 36: For personal use only
For personal use only Prof Vivekanand Jha ( 36
Slide 37: COPD references
For personal use only $ Aernout van Haarst A., McGarvey L., Paglialunga S., 2019 “Review of Drug Development Guidance to Treat Chronic Obstructive Pulmonary Disease: US and EU Perspectives”; in Clinical Pharmacology & Therapeutics, Vol.0 July 2019 (https://ascpt.onlinelibrary.wiley.com/doi/full/10.1