Slide 1: Investor Presentation December 2020
Dimerix Investor Presentation December 2020 @ 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 Public company clinical programs with (ASX: DXB) early monetisation opportunities DMX-200: renal ) DMX-200: COVID-19 Lead Phase 3 program in Two late stage (Phase 3) orphan renal condition studies with near term ith Accelerated Approval i f} readouts end point Z >US
Slide 4: Corporate overview
Corporate overview @asx Ticker Symbol ASX:DXB tn! Average volume 1,877,843 | Share price ~A$0.235 52 week change 89% vy e - WS Total ordinary shares on issue 197,749,297 we Cash Balance (30Sep20*) A$6.5 million 0° or Market Capitalisation (200ct20) _A$46 million a Top 20 Shareholders own 33.35% Ty T
Slide 5: Value roadmap near term value inflection points
Value roadmap 3 near term value inflection points Potential for : CLARITY PHASE 3 COVID49 STUDY (Respiratory Complications) - Revenue stream on two COVID-19 opportunities Primary endpoint - Commercial transaction on two COVID-19 opportunities Potential emergency use - Commercial transaction FSGS opp
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Slide 7: FSGS commercial rationale
FSGS commercial rationale Commercially attractive and growing markets * Major unmet medical need, affecting both children and adults * Existing efficacy and safety data from prior clinical studies (including in FSGS) support progression to Phase 3 * Clear recruitment window allowing consolidation of
Slide 8: For personal use only
For personal use only Renal failure in <5 years from diagnosis – dialysis or transplant # Transparency Market Research, 2018, Focal Segmental Glomerulosclerosis (FSGS) Market, Global Industry Analysis, Size, Share, Growth, Trends, & Forecast 2017-2025, [ONLINE] Available at: https://www.transparency
Slide 9: Kidney asset transactions by clinical phase
Kidney asset transactions by clinical phase Kidney assets are in active M&A space, including: Company Year Structure Upfront (US$) Milestones (US$) Royalties Preclinical Epigen to Novo Nordisk May-18 licensing undisclosed $200m undisclosed Goldfinch to Gilead (Goldfinch to complete development) May-
Slide 10: FSGS competitive positioning
FSGS competitive positioning Dimerix Dimerix Interim data in DKD proposed Ph2 data Complexa Phase 3 study Dimerix Travere Ph2 data Goldfinch FSGS (formerly Retrophin) Ph2a data Pfizer Ph2a data Ph3 data Study reported as Ph2 data active, but not recruiting Q2 20 | H Ht 22 1 ' No other global FSGS st
Slide 11: Proposed Phase 3 FSGS study design overview
Proposed Phase 3 FSGS study design overview* Single, seamless Phase 3 study design + 26 weeks 52 weeks 52 weeks ~~ YO ~~ Y Screen | Run-in Part 1 Part 2 Follow-up N=85 N=120-180* DMX-200 Eligibility All patients remain on stable ARB throughout study ee xg bn: First patient Interim analysis Interim a
Slide 12: Product candidates in the pipeline, with clinical opportunities
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
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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 15: End of Presentation
DIMERIX End of Presentation 425 Smith St, Fitzroy 3065 Victoria, Australia T. 1300 813 321 E. bd@dimerix.com
Slide 16: Additional Supporting Materials
Additional Supporting Materials
Slide 17: For personal use only
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 18: For personal use only
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 18
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Slide 20: DMX-200 addresses three key mechanisms that cause 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
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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 22: 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
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Slide 24: uMCR normalised to baseline v 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) • ▪ ▪ 24
Slide 25: 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
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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 FSGS Chronic Kidney Disease Phase 2a initiated for FSGS & - November studies readout; planned for H1 Disease study completed diabetic kidney disease dialogue wi
Slide 27: 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 28: Acute Respiratory Distress Syndrome (ARDS) COVID-19 patients
Acute Respiratory Distress Syndrome (ARDS) COVID-19 patients warded A$1 million from AUS Government REMAP-CAP REMAP-CAP: global clinical study in ARDS; >260 clinical sites in 19 countries* REMAP-CAP has been designated by the WHO as a Pandemic Special Study* translation of clinical trial results occ
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For personal use only Prof Vivekanand Jha ( 29
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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 31: For personal use only
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