Clinical trial update at J.P. Morgan Healthcare Conference
2026-01-12 · Dimerix Bioscience Pty Ltd · original dimerix.com ↗
Dimerix is a biopharmaceutical company developing innovative new therapies in areas with unmet medical needs. Dimerix HQ 425 Smith St, Fitzroy 3065 Victoria, Australia T. 1300 813 321 E. [email protected] For Immediate Release DIMERIX TO MEET INVESTORS AND PARTNERS AT J.P. MORGAN HEALTHCARE CONFERENCE 2026 MELBOURNE, Australia, 12 January 2026: Dimerix Limited (ASX: DXB), a biopharmaceutical company with a Phase 3 clinical asset in kidney disease, is pleased to advise that CEO and Managing Director, Dr Nina Webster, will be attending the 44th Annual J.P. Morgan Healthcare Conference at the Westin St Francis in San Francisco, California on 12-15 January 2026. During the conference, Dr Webster will meet with investors and partners to provide an update on the following: • Phase 3 global clinical trial in FSGS kidney disease , including updated patient numbers and a breakdown on recruitment by country • Commercial partnering status • Company growth strategy Any investors or potential partners interested in meeting with Dr Webster at the conference should reach out via: [email protected]. A copy of the presentation is attached. For further information, please visit our website at www.dimerix.com or contact: Dr Nina Webster Dimerix Limited Chief Executive Officer & Managing Director Tel: +61 1300 813 321 E: [email protected] Jane Lowe IR Department Tel: +61 411 117 774 E: [email protected] Follow us on LinkedIn and X Authorised for lodgement by the Board of the Company —END— About Dimerix Limited Dimerix (ASX: DXB) is a clinical-stage biopharmaceutical company working to improve the lives of patients with inflammatory diseases, including kidney diseases. Dimerix is currently focused on developing its proprietary Phase 3 product candidate DMX-200, for Focal Segmental Glomerulosclerosis (FSGS) kidney disease, and is also developing DMX -700 for respiratory disease. DMX -200 and DMX -700 were both identified using Dimerix’s proprietary assay, Receptor Heteromer Investigation Technology (Receptor -HIT), whi ch is a scalable and globally applicable technology platform, enabling the understanding of receptor interactions to rapidly screen and identify new drug opportunities. For more information, please visit the company’s website at www.dimerix.com and follow on X and LinkedIn. About DMX-200 DMX-200 is a chemokine receptor (CCR2) antagonist administered to patients already receiving an angiotensin II type I receptor (AT1R) blocker, the standard of care treatment for hypertension and kidney disease. DMX-200 is protected by granted patents in va rious territories until 2032, with patent applications submitted globally that may extend patent protection to 2042, in addition to Orphan Drug Designation granted by the FDA in the United States. About FSGS FSGS is a rare, serious kidney disorder characterised by progressive scarring (sclerosis) in parts of the glomeruli—the kidney’s filtering units. This scarring leads to proteinuria, progressive loss of kidney function, and often end-stage renal disease. FSGS is increasingly understood to have an inflammatory component, with monocyte and macrophage activation contributing to glomerular injury. In the United States, more than 40,000 people are estimated to be living with FSGS, including both adults and childr en.1 There are no therapies specifically approved for FSGS in the U.S., and disease management relies on non-specific immunosuppressive and supportive therapies. In patients with progressive or treatment -resistant FSGS, the average time from diagnosis to end -stage kidney disease can be as short as five years. Even among those who undergo kidney transplantation, disease recurrence occurs in up to 60% of cases, 2 underscoring the urgent need for new, disease-modifying treatments. About FSGS Phase 3 Study The ACTION3 Phase 3 study is a pivotal Phase 3, multi -centre, randomised, double-blind, placebo-controlled study of the efficacy and safety of DMX -200 in patients with FSGS who are receiving a stable dose of a blood pressure medication known as an angiotensin II receptor blocker (ARB). Once the ARB dose is stable, patients are then randomised to receive either DMX-200 (120 mg capsule, twice daily) or placebo for a 2-year treatment period. The single Phase 3 trial in FSGS patients is designed to capture evidence of proteinuria reduction a nd kidney function (eGFR slope) during the trial, aimed at generating sufficient evidence to support marketing approval. Further information about the study can be found on ClinicalTrials.gov (Study Identifier: NCT05183646) or Australian New Zealand Clinical Trials Registry (ANZCTR) (Study Identifier ACTRN12622000066785). Dimerix Forward Looking Statement This release includes forward -looking statements that are subject to risks and uncertainties. Although management believes that the expectations reflected in the forward-looking statements are reasonable at this time, Dimerix can give no assurance that these expectations will prove to be correct. Readers are cautioned not to place undue reliance on forward -looking statements. Actual re sults could differ materially from those anticipated. Reasons may include risks associated with drug development and manufacture, risks inherent in the regulatory processes, delays in clinical trials, results of clinical trials, contractual risks, risks associated with patent protection, future capital needs or other general risks or factors, along with those factors outlined in the most recent Dimerix Limited Annual Report. References 1 Nephcure FSGS Facts (https://nephcure.org/) 2 Front. Immunol., (July 2019) | https://doi.org/10.3389/fimmu.2019.01669 Authorised for lodgement by the Board of the Company Developing new therapies to treat inflammatory causes of kidney disease with unmet clinical needs Investor Presentation J.P . Morgan Healthcare Conference 12-15 January 2026 San Francisco, California 2 Forward looking statements This presentation includes forward-looking statements that are subject to risks and uncertainties. Although we believe that the expectations reflected in the forward looking statements are reasonable at this time, Dimerix can give no assurance that these expectations will prove to be correct. Readers are cautioned not to place undue reliance on forward-looking statements. Actual results could differ materially from those anticipated. Reasons may include risks associated with drug development and manufacture, risks inherent in the regulatory processes, delays in clinical trials, results of clinical trials, contractual risks, risks associated with patent protection, future capital needs or other general risks or factors, including but not limited to those factors outlined in the most recent Dimerix Limited Annual Report. 3 Overview Phase 3 Global Opportunity 1. Guruswamy Sangameswaran KD, Baradhi KM. Focal Segmental Glomerulosclerosis (July 2021), online: https://www.ncbi.nlm.nih.gov/books/NBK532272/; 2. ASX releases: 14 December 2015, 21 November 2018, 07 June 2021; 3. ASX release 05 October 2023, 27 May 2024, 07 January 2025 and 01 May 2025 FSGS indication is a rare disease that causes scarring of the kidney, leading to irreversible damage1 No approved treatments specifically for FSGS: damage can lead to dialysis, transplant or death1 Orphan drug designations regulatory, marketing exclusivity and pricing benefits in key territories2 4 commercial partners DMX-200 licensed in USA, Europe, Canada, Australia, NZ, Japan and GCC3 >$65 million in total upfront payments received to date3 up to $1.4 billion in total development and sales milestone payments plus royalties3 Phase 3 trial recruitment complete in trial of DMX-200 in focal segmental glomerulosclerosis (FSGS) 4 Corporate overview 1. As at 09 January 2026; 2. Past 30 trading days liquidity as at 09 January 2026; 3. Shareholder register as at 09 January 2026 Ticker Symbol ASX: DXB Cash Balance (Sep25) $49.2 million Market Capitalisation1 $330 million Share price1 $0.55 Total ordinary shares on issue1 600,396,776 Average Daily Liquidity by value for past 30 trading days2 $1.2 million S H A R E P R I C E S U B S T A N T I A L S H A R E H O L D E R S 3 Position Holder Name Holding % IC 1 Mr P Meurs 87,259,311 14.5% TOTAL (TOP 5) Shareholders 146,459,621 24.4% 5 Cycle of damage : in glomerular diseases What is FSGS? Focal = some Segmental = sections Glomerulo = of the kidney filtering units Sclerosis = are scarred 3 Pro-inflammatory environment drives sclerosis and fibrosis that is permanent and non-reversable 2 Constant pressure causes inflammation of glomerulus and influx of inflammatory immune cells 1 High blood pressure causes hyperfiltration within filter units (glomeruli) of the kidney1 Fewer kidney cells drive higher blood pressure and further hyperfiltration and inflammation As cells die, glomerular become scarred and protein leaks into the urine (proteinuria) Glomeruli exposed to stress from high blood pressure 1. Lewis, E. J. et al. (2001), New Engl J Medicine 345, 851 –860 DMX-200 Existing blood pressure medication 6 Measuring kidney damage – surrogate endpoints 1. National Kidney Foundation: Estimated Glomerular Filtration Rate (eGFR): https://www.kidney.org/atoz/content/gfr; 2.Gurusw amy Sangameswaran KD, Baradhi KM. Focal Segmental Glomerulosclerosis (July 2021), online: https://www.ncbi.nlm.nih.gov/books/NBK532272/; 3. Nephcure FSGS living with the disease (2024) at https://nephcure.org/livingwithkidneydisease/ns-and-other-glomerular-diseases/understanding-fsgs/ 1. Proteinuria • A healthy kidney is a good filter and allows little to no protein into the urine2 • When kidneys are damaged, protein can leak into the urine causing proteinuria • Proteinuria represents an important early marker of kidney function3 Inside a healthy kidney Inside a damaged kidney Treatments, such as DMX-200, aim to bring the FSGS slope back up: • can add years to the life of the kidney • potential to delay dialysis and/or kidney transplant 2. Estimated glomerular filtration rate (eGFR) • Kidney function is measured using the estimated rate of blood filtered by the kidney per minute (millilitres per minute) • eGFR slope naturally declines as we age1 • In FSGS patients, kidney function is decreasing rapidly 7 Simultaneous inhibition of CCR2 and AT1R preserves the number of essential filter cells (podocytes) in the kidney1 Sham Vehicle DMX-200 ARB DMX-200 +ARB Podocytes, n/gcs 20 15 10 5 0 * * * † Sham Vehicle DMX-200 ARB DMX-200 +ARB Macrophages, n/area 200 150 100 50 0 * † † †§ Simultaneous inhibition of CCR2 and AT1R reduces recruitment of monocytes to the kidney1 uMCR = Urinary MCP-1 creatine ratio; PCR = protein creatinine ratio; *placebo adjusted difference; 1. Ayoub MA, et al. (2015) PLoS One; doi.org/10:e0119803; 2. ASX presentation 27 October 2020; 3. Liu Y. et al (2024) Role of MCP-1 as an inflammatory biomarker in nephropathy, Front. Immunol., Sec. Inflammation doi.org/10.3389/fimmu.2023.13030762.4. De Vriese, AS, et al. (2021) Nat Rev Nephrol (2021). https://doi.org/10.1038/s41581 -021-00427-1; 2. Unlike other CCR2 antagonists investigated to date, treatment with DMX-200 reduces the urine concentration of the pro- inflammatory ligand of CCR2 called MCP-12 • CCR2 activation promotes recruitment of inflammatory monocytes to the kidney • Monocytes promote sclerosis and fibrosis of the kidney • Podocytes are the essential filter cells of the kidney -100% -50% 0% 50% 0 8 16 uMCR normalised Weeks On active On placebo -37%* -39%* DMX-200 inhibits CCR21 DMX-200 reduces inflammatory cells1,2,3 DMX-200 preserves podocytes1 in-vivo in-vitro in-human Complex of CCR2 and AT1R increases aberrant signaling when both receptors activated1 MCP-1 & Angiotensin II present Only MCP-1 present Angiotensin II present No ligand DMX-200: unique pharmacology 8 “Any reduction in proteinuria could yield years of preserved native kidney function and delay the onset of kidney failure and its attendant morbidity and mortality” Kidney survival study – Troost et al, August 20203 DMX-200: Phase 2 met primary and secondary endpoints PCR = protein creatinine ratio; ARB = angiotensin receptor blocker; 1. Repeated measures mixed model analysis per protocol; t op line data was reported as grouped analysis on 29 July 2020, study not designed for statistical significance; 2. Trachtman, et al., 2018. J Amer Soc Nephrology 29(11):2745 -2754; 3. Troost JP et al (August 2020); doi.org/10.1053/j.ajkd.2020.04.014 Clinically meaningful outcomes achieved for patients,2,3 with no safety concerns E F F I C A C Y • 86% of patients demonstrated reduced proteinuria • DMX-200 reduced inflammatory biomarker by 39% vs placebo S A F E T Y • No safety concerns – reduced development risk Average reduction of 17% in proteinuria after 16 weeks treatment on DMX-200 versus placebo1 9 phase 3 clinical trial 1. Interim Phase 3 analysis data does not guarantee a statistically significant outcome at the end of the trial, ASX release 11 March 2024; 2. The potential for accelerated (or conditional) approval submissions, following the second interim analysis and any required unblinding, will be assessed based on outcomes from PARASOL analysis, discussions wi th the appropriate regulatory authorities such as the FDA in the US and blinded statistical powering outcomes; 3. Regardless of any accelerated (conditional) approval potential, ACTION3 study will complete full 2 year analysis and regulatory submission for potential traditional (full) approval; 4. number and % of eligible patients who have completed 2 years treatment as at 05 January 2026; ARB = angiotensin receptor blocker; uPCR = urinary proteinuria; eGFR = estimated glomerular filtration rate (kidney function); A randomised, double-blind, multi-centre, placebo-controlled study of renal outcomes of DMX-200 in patients with FSGS receiving an ARB (n=≥286) ARB + DMX-200 ARB + placebo Planned blinded statistical powering analysis2 Phase 3 Trial Timeline Final analysis ≥286 patients @ 104 weeks (uPCR/eGFR)3 Background • Patients recruited, then screened and stabilised on background medications • Patients randomised to receive drug or placebo • DXB remains blinded at all times during study Open Label Extension DMX-200 71/75 (95%)4 patients enrolled in open label extension study to date ACTION3 Study End planned blinded statistical powering analysis assuming FDA alignment 2 European Renal Association Posters 2025 Successful interim analysis1 (using statistical measure) 72 patients @ 35 weeks (% change in uPCR) 10 Adult patient recruitment by territory Trial designed for potential approval globally Recruitment completed (adult population)1 1. ASX release 15 December 2025; 2. As at 09 January 2026, allowing for those recruited to complete stabilisation and second screening; paediatric patients will continue to recruit, and will not impact final analysis timelines 309 Adult patients recruited, randomised and dosed (target ≥286)2 5 Paediatric patients recruited, randomised and dosed2 Latin America Asia Pacific US / Europe 11 Blinded analysis process Step 1 PARASOL FSGS working group 12- month data analysis received1 Step 2 Seek FDA alignment on endpoints and process for traditional approval and potential accelerated approval endpoints2 Step 3 Blinded statistical powering analysis for final endpoints and ACTION3 clinical study protocol updates2,3 Step 4 Final decision timeline for traditional and/or accelerated approval analysis2,3 ~1 month4~1 month4 1. ASX release 08 October 2025; 2. ASX release 28 April 2025 and 24 December 2025; 3. The potential for unblinding and accele rated (or conditional) approval submissions will be assessed based agreement with the appropriate regulatory authorities such as the FDA in the US and the outcomes of the planned blinded statistical powering ana lysis; 4. Timing subject to FDA feedback and regulatory acceptance in each territory PARASOL working group conducted “ACTION3-like” population analysis of larger PARASOL observation dataset1,2 • Results of this analysis are generally consistent with the broader PARASOL analysis conducted in 2024 • Potential relationship between proteinuria at 12 months and subsequent risk of kidney failure observed that may support proteinuria as an endpoint for marketing approval When FDA aligned with endpoints Timing of analysis based on protocol update in each territory 12 Phase 1 Phase 2 Phase 3 Company DMX-200 Sparsentan Travere Therapeutics VX-147 Vertex Pharmaceuticals BI-764198 Boehringer Ingelheim Atrasentan Chinook Frexalimab, Brivekimig, Rilzabrutinib (basket) Sanofi R3R01 River 3 Renal Sources: Company Documents, Statutory and Regulatory Filings APOL1 inhibitor – targeting a specific type of genetic FSGS TRPC6 inhibitor ETAR antagonist Lipid modifying Inflammatory modulator Low competition in inflammatory treatment options, huge unmet medical need DMX-200 is the only inflammatory modulator in development AT1R/ETAR dual antagonist – Failed Phase 3 eGFR endpoint: resubmitted to FDA on proteinuria endpoints CD40L antagonist, TNF-⍺/OX40L antagonist, TKI Competitive landscape in FSGS 13 Rare kidney disease – a potential growth market 1. Kitiyakara et al Trends in the epidemiology of focal segmental glomerulosclerosis. Semin Nephrol. 2003 Mar;23(2):172 -82. doi: 10.1053/snep.2003.50025. PMID: 12704577; 2. The United States Renal Data System (USRD), 2023 Annual Report, End Stage Renal Disease; 3. ASX investor presentation 09Mar20; 4. https://www.reuters.com/business/healthcare -pharmaceuticals/us-fda-approves-travere-therapeutics-kidney-disorder-drug-2023-02-17/; 5. http://www.vanrafia.com; 6. Ito, et al., 2025. https://doi.org/10.1182/blood.2024025176; 7 . https://endpts.com/fda-clears-traveres-rare-kidney-disease-drug-will-come-with-rems-program; 8. Micromedex Red Book (2025) Com prehensive drug pricing and product information; 9. UK list price (2025) https://www.nice.org.uk/guidance/TA937/chapter/2 -information-about-targeted-release-budesonide; 10. J Mark Access H ealth Policy. 2016 Mar 15;4:10.3402/jmahp.v4.30458. doi: 10.3402/jmahp.v4.30458 Example price for other rare kidney disease drugs per patient: in the US (i.e. Kinpeygo/Tarpeyo in IgAN)8: US$15,123 per month in the UK (Kinpeygo/Tarpeyo in IgAN)9: US$8,797 per month Other key territories, including Middle East and China, use US and/or Europe as pricing reference10,11 DMX-200 Commercial manufacturing sites established in USA3 Example pricing: USA retail price for IgA Nephropathy products Global incidence rate of FSGS per capita, per year1 7 per 1,000,000 FSGS is the most frequent primary glomerular disease that reaches end-stage renal failure in the US2 FSGS diagnosis driven by rates of biopsy - growth potential as biopsy rates increase Biopsy 14 1. ASX release 01 May 2025; 2. Based on Euro conversions & further terms outlined in ASX Announcement on 5 October 2023; 3. B ased on US dollar conversions & further terms outlined in ASX Announcement on 27 May 2024; 4. Based on Japanese ¥ Yen conversions & further terms outlined in ASX Announcem ent on 7 January 2025 Licensing deals collectively valued up to ~AU$1.4 billion in total upfront and potential milestone fees plus royalties1 Dimerix has successfully partnered DMX-200 across key markets United States AU$48 million1 Upfront Up to AU$892 million1 Milestones Escalating low- teen-low twenties% Royalties EU, CA, AU, NZ AU$10.8 million2 Upfront Up to AU$219 million2 Milestones Escalating mid-teen-20% Royalties GCC, Iraq AU$0.5 million3 Upfront Up to AU$120 million3 Milestones Starting at 30% Royalties Japan AU$7.2 million4 Upfront + 1st milestone Up to AU$100 million4 Milestones Between 15- 20% Royalties 1 2 3 4 Significant potential additional global deal value remains, as Dimerix pursues and progresses licensing opportunities with potential partners outside the licensed territories Over AU$65 million in total payments received Summary of licensing deals for DMX-200 to date 15 Intellectual property portfolio Exclusivity 7/10 years Orphan exclusivity from marketing approval date in many territories1 + Paediatric exclusivity period extension1 Portfolio 2 Exp.2042 (if granted) Method of Use & Formulation Global application3 1. DMX-200 is a “New Chemical Entity: an active moiety not previously approved, which can attract exclusivity periods in various territories; 2. Granted patents US9,314,450, US10,058,555, US10,525,038, US11,382,896, US12,083,102, CN2012800046165, CA2,821,985, EP12734251.7, HK 1404477.8 , IL227414, JP2013-547780, SA2013/5897, AU2012206945; 3. Patent applications: PCT/AU2022/050013, PCT/AU2022/050249 and PCT/AU2024/050416; 4. US Provisio nal Application 63/887,984 Portfolio 3 Exp.2042 (if granted) Formulation Global application3 Portfolio 5 Exp.2045/6 (if granted) Method of Use Provisional application4 Trademarks Various trademarks Global applications Portfolio 1 Exp.2032 (2033 in US) Method of Use Granted in key territories2 Portfolio 4 Exp.2044 (if granted) Method of Use & Formulation Global application3 DMX-200 16 Deliver ACTION3 Phase 3 clinical trial • Ensure drug supply continuity and patient visits for recruited patients • Complete recruitment of paediatric patients • Maintain regulatory engagement (FDA, EMA, PMDA, NMPA + others) • With partners, prepare for potential market approval and launch readiness Expand global commercial partnerships • Build on existing licensing agreements and relationships • Secure additional partnerships to expand and accelerate market access Advance pipeline development • Identify and progress new assets in renal and/or rare disease indications • Leverage DMX-200 platform for additional indications Grow sustainable shareholder value through clinical success, global partnerships, and pipeline diversification Growth strategy 17 DMX-200 licensed in US for up to ~AU$940 million1 DMX-200 licensed in Japan for up to ~AU$107 million2 Positive Type C meeting: FDA confirmed proteinuria-based endpoint acceptable for full marketing approval in the US3 First development milestone received from FUSO of AU$4.1 million 4 Outcome of PARASOL working group analysis received5 Phase 3 trial recruitment complete with >286 adult patients6 ➢ FDA outcome on endpoints anticipated Q1 CY 20267 ➢ Blinded interim data collection anticipated in Q1 CY 20267 • Potential for accelerated (or conditional) approval submission, subject to FDA feedback and blinded analysis outcomes3,7 ➢ Additional pipeline opportunity(s) to be announced ➢ Additional commercial licensing partners for DMX-200: Dimerix continues to pursue potential licensing opportunities in un-licensed territories, including China ➢ Additional development milestone payments from existing licensees if milestone achieved 1. ASX release 01 May 2025; 2. ASX release 07 January 2025 3. FDA Meeting Outcomes, ASX release 28 April 2025; 4. ASX release 30 June 2025; 5. ASX release 08 October 2025; 6. ASX release 15 December 2025; 7. ASX Release 24 December 2025; FY 2024/25 1 Potential upside 3 FY 2025/26 2 Achievements and potential catalysts 18 W E L L P O S I T I O N E D TO D E L I V E R AGA I N ST ST R AT E G I C P L A N Dimerix HQ 425 Smith St, Fitzroy 3065 Victoria, Australia T. +61 1300 813 321 E. [email protected] (ASX:DXB) A biopharmaceutical company developing innovative new therapies in areas with unmet medical needs, with a core focus on inflammatory disease treatments such as kidney and respiratory diseases. ESG Statement Dimerix is committed to integrating Environmental, Social and Governance (ESG) considerations across the development cycle of its programs, processes and decision making. The Dimerix commitment to improve its ESG performance demonstrate a strong, well-informed management attitude and a values led culture that is both alert and responsive to the challenges and opportunities of doing business responsibly and sustainably. 19 Mark Diamond BSc, MBA Non-Executive Chairman Previous experience: • Senior pharmaceutical executive with a demonstrated record of achievement and leadership over more than 30 years within the pharmaceutical and biotechnology industries • Significant accomplishments in capital raising initiatives, pipeline development and licensing ✓ BSc − Chemistry ✓ MBA − Business Nina Webster PhD, MBA, M.IP.Law CEO & Managing Director Previous experience: • Experienced in product development, commercial strategy development & execution • Successfully commercialized pharmaceutical products globally ✓ BSc (Hons) − Pharmacology ✓ PhD − Pharmaceutics ✓ MBA − Business ✓ M.IP.Law − Intellectual Property Law Hugh Alsop BSc (Hons), MBA Non-Executive Director Previous experience: • Extensive biotech drug development & commercial manufacturing experience • Responsible for successful global commercialization programs & NDA registrations ✓ BSc (Hons) − Chemistry ✓ MBA − Business Sonia Poli PhD Non-Executive Director Previous experience: • Experienced executive in pharmaceutical operations • Background in small molecules development and analytical development ✓ BSc (Hons) − Chemistry ✓ PhD – Industrial Chemistry Clinton Snow BEng (Hons), BCom Non-Executive Director Previous experience: • Experienced technology and governance professional with a focus in operations, risk management, assurance, and AI • Provides advisory services to a family office with multiple Australian biotech investments ✓ BEng (Hons) − Chemical Engineering ✓ BCom − Commerce (Faulding)(1) 1. Acquired by Pfizer in 2015; 2. Acquired by Pfizer in 2009 (2) (1) Dimerix board 20 David Fuller B. Pharm (Hons), MBBS CMO Dimerix management Nina Webster PhD, MBA, M.IP.Law CEO & Managing Director Hamish George Bcom, CA, GIA (Cert) CFO & Company Secretary Robert Shepherd PhD, MBA, COO Bronwyn Pollock BSc (Hons), MBA VP, Product Development Previous experience: • Experienced in product development, commercial strategy development & execution • Successfully commercialised multiple pharmaceutical products ✓ BSc (Hons) − Pharmacology ✓ PhD − Pharmaceutics ✓ MBA − Business ✓ M.IP.Law − Intellectual Property Law (1) 1. Acquired by Pfizer in 2009; 2. Acquired by Pfizer in 2015 Previous experience: • Experienced CFO & Co.Sec • Expertise in Corporate Governance, financial reporting, cash flow management, taxation (including R&D Tax Incentive) & budgeting/forecasting ✓ Bcomm – Commerce ✓ G.Dip. - Financial Planning ✓ M.Acc. – Accounting ✓ GIA(Cert) ✓ Chartered Accountant Previous experience: • 35 years international experience in drug development, commercialization and corporate leadership • Planning, Financing, Pre-clinical, Clinical Development, Regulatory Approval, Product Launch, Pharmacovigilance, and Medical Affairs ✓ B.Pharm (Hons) - Pharmacy ✓ MBBS - Medicine and Surgery Previous experience: • Experienced pharmaceutical executive in project management, clinical development and research translation • BD and strategic alliance leader • Led multidisciplinary R&D&C teams for 13 years ✓ BSc (Hons) – Genetics ✓ PhD – Molecular Immunology ✓ MBA – Business & Leadership Previous experience: • Experienced pharmaceutical executive in Manufacturing (CMC) • Successfully developed and submitted multiple dossiers to FDA, EMA, TGA • Background in project management, technical transfer and product launch ✓ BSc (Hons) – Applied Biology ✓ MBA - Business (2) 21 Medical Advisory Board Professor Hiddo Heerspink PhD Professor of Clinical Trials and Personalized Medicine: University Medical Center Groningen, the Netherlands. He specializes in the research of novel treatment approaches to slow the onset of diabetic cardiovascular and renal disease. Hiddo has been instrumental in interactions between industry, researchers and regulatory agencies in the validation of surrogate endpoints for renal trials. Professor Alessia Fornoni MD, PhD, FASN Professor of Medicine & Molecular & Cellular Pharmacology: University of Miami. Chief of the Katz Family Division of Nephrology and Hypertension. She has an extensive history of translational excellence for patients with renal disease and has uncovered novel pathogenetic mechanisms and therapeutic approaches for glomerular disorders. Professor Jonathan Barratt MD, PhD, FRCP Mayer Professor of Renal Medicine: Department of Cardiovascular Sciences; University of Leicester and Nephrologist. Jonathan is the IgA nephropathy Rare Disease Group lead for the UK National Registry of Rare Kidney Diseases (RaDaR) and a member of the steering committee for the International IgA Nephropathy Network. Associate Professor Lesley Inker MD, MS, FRCPC An attending physician and Director of the Kidney and Blood Pressure Center in the Division of Nephrology at Tufts Medical Center. Lesley’s major research interest is in the estimation and measurement of glomerular filtration rate (GFR) and in defining alternative endpoints for CKD progression trials based on GFR decline and changes in albuminuria. Dr Muh Geot Wong MBBS, PhD, FRCP Renal Physician and Head of the Renal Clinical trials at the Royal North Shore hospital, Sydney, Australia. Muh Geot’s main areas of research are in understanding the mechanisms of kidney fibrosis, biomarkers research, and identifying strategies in delaying progressive kidney disease including glomerular diseases. Professor Howard Trachtman MD, FASN Graduated from Haverford College and the University of Pennsylvania School of Medicine. He has been a practicing pediatric nephrologist for 35 years. Has been the PI of NIDDK and industry sponsored clinical trials in glomerular disease and am a Co-Investigator in the NEPTUNE and CureGN observational cohort studies. Associate Professor Laura Mariani MD, MSCE Assistant Professor in the Division of Nephrology at the University of Michigan. Interest in observational studies in glomerular disease, including NEPTUNE and CureGN. Lead on PARASOL program to define FSGS endpoints with by applying statistical methods for clinical outcome definition and prediction of kidney disease progression. 22 Renal disease landscape “A squeaky wheel waiting for grease: 50 years of kidney disease management in the US”1 2018: workshops and regulatory acceptance of surrogate end points in trials of kidney diseases 2 2019 changes in US federal policy and rapid adoption of treatment guidelines have contributed to a sea change in the management of renal disease 3 Historical lack of incentives and public policy have contributed to high costs and poor health outcomes for renal patients1 Public health policy, legislation and product innovation have converged to accelerate change in renal space today “More change in the past 24 months than the past 24 years: The rapid evolution of [kidney disease] management”1 1.Garibaldi A, et al (2021) The Evolution of Kidney Health Management and the Next Frontier; https://www.lek.com/insights/ei/ evolution-kidney-health-management-and-next- frontier; 2. FDA, EMA, National Kidney Foundation Workshop Summary: https://www.kidney.org/news/accelerating -new-clinical-trials-and-treatments-kidney-disease; 3. Thompson, A et al (2019) Change in Estimated GFR and Albuminuria as End Points in Clinical Trials: A Viewpoint From the FDA D OI: 10.1053/j.ajkd.2019.08.007 23 Clinical study change: use of surrogate endpoints Pre-2018 2018 2019 2020 2021 "Hard" endpoints for kidney disease (kidney failure) may not be reached for decades1 US FDA, European EMA, and US National Kidney Foundation hold scientific workshop on proteinuria & glomerular filtration rate (GFR) as endpoints for clinical studies in kidney disease2 FDA publish willingness to consider fixed glomerular filtration rate (GFR) and proteinuria decline as surrogate end points for kidney failure in certain conditions3 Publications demonstrate relationship between proteinuria as a continuous variable and kidney survival in FSGS patients4 FDA grants first accelerated approval drug based on proteinuria endpoint in a rare kidney disease, IgA nephropathy5 1.Hartung E, (2015), Pediatric Nephrology volume 31, pages381 –391 DOI: 10.1007/s00467-015-3104-8; 2. FDA, EMA, National Kidney F oundation Workshop Summary: https://www.kidney.org/news/accelerating -new-clinical-trials- and-treatments-kidney-disease; 3. Thompson A et al, (2019) Am J Kidney Dis.; 75(1):4 -5: doi.org/10.1053/j.ajkd.2019.08.007; 4. Troost JP et al, (2020) Am J Kidney Dis.; 77(2):216-225: doi.org/10.1053/j.ajkd.2020.04.014; 5. FDA Drug Approvals: https://www.fda.gov/drugs/fda-approves-first-drug-decrease-urine-protein-iga-nephropathy-rare-kidney-disease; 6. ASX release 23Dec2021; 7. Predictive Power statistical model, using industry standard as set by the independent renal biostatistician consultant for Dimerix, . Interim Phase 3 analysis data does not guarantee a statistically significant outcome at the end of the trial, ASX release 11 March 2024; 2022 Dimerix starts recruiting patients for global Phase 3 study in FSGS patients using approvable surrogate endpoints6 A surrogate endpoint is an intermediate outcome which substitutes the hard endpoint for a disease (e.g. kidney failure), which can take much longer to achieve 2023 2024 FDA led working group, called PARASOL, initiated to assess alternative surrogate endpoints for FSGS Dimerix Phase 3 Interim analysis (n=72 @ 35 weeks) showed DMX-200 performing better than placebo in reducing proteinuria7 24 Kidney disease is high interest area for pharma 1. Editorial, Time to sound the alarm about the hidden epidemic of kidney disease, Nature 628, 7-8 (2024) doi: https://doi.org/10.1038/d41586-024-00961-5; 2. The United States Renal Data System (USRDS) Annual Report 2023; (2022 & 2023 estimates based on average growth 2001 -2021) 3. Francis et al. (2024), Nature Rev. Nephrol. https://doi.org/10.1038/s41581-024-00820-6 Prevalence of Kidney Failure, 2001-20232 Year Number of patients Kidney disease is the third-fastest-growing cause of death globally1 • In the US alone, the number of people with kidney failure increased by >200% from 2001 to 20232 • By 2040, it is expected to become the fifth-highest cause of years of life lost1,2 The US government-funded health-care plan (Medicare) spent US$130 billion in 2023 to treat kidney disease patients • the majority being on dialysis1,3 25 New Chemical Entity status, with orphan exclusivity (7 years US/10 years EU)2; and with granted patents and applications across key countries 2 x 120mg capsule daily Consistently safe and well tolerated in both healthy volunteers and renal patients (more than 200 patients dosed)3 4 clinical studies completed to date: positive efficacy signals across studies3 Small molecule Easy & convenient dosing Strong safety profile3 Positive efficacy signals3 DMX-200 – working on inflammatory signalling pathway A CCR2 inhibitor working synergistically alongside the current standard of care (AT1R blocker): G protein-coupled receptor (GPCR) 1. ASX release: 09May2022; 2. ASX releases: 14Dec15, 21Nov18, 07Jun21; 3. ASX release and investor presentation 29Jul20 and ASX release 11Mar24 26 DMX-200 unique heteromer pharmacology ARB: Irbesartan, * P<0.05 vs sham, # P<0.05 vs un-treated STNx, f P<0.05 vs STNx+Irb. Ayoub MA, et al. (2015) PLoS ONE 10(3): e0119803. 1. FDA written correspondence Macrophage infiltration Proteinuria Retained podocyte numbers Proposed non-clinical safety package suitability for NDA confirmed with FDA1 Proprietary discovery platform (Receptor-HIT) identified: • Formation of AT1R and CCR2 heteromers; • Novel pharmacology (potentiation of signaling) • Dual antagonism required for completed inhibition 27 DMX-200 Phase 2 effect on inflammatory biomarker1 uMCR = Urinary MCP-1 creatine ratio; PCR = protein creatinine ratio; *placebo adjusted difference 1. ASX presentation 27 October 2020; 2. Liu Y. et al (2024) Role of MCP-1 as an inflammatory biomarker in nephropathy, Front. Immunol., Sec. Inflammation doi.org/10.3389/fimmu.2023.1303076 Average baseline MCP-1 versus average baseline proteinuria MCP-1 levels reduced when on DMX- 200 treatment 0 5 10 15 0.0 0.5 1.0 1.5 Time uMCR normalised uMCR normalised to baseline v time N=7, GeoMean On active On placebo (weeks) -37%* -39%* 50% 0% -50% high MCP-1 correlates to high proteinuria Change in MCP-1 over time on DMX-200 versus placebo • 16 weeks treatment with DMX-200 vs placebo reduced inflammatory biomarker by 39%: ▪ DMX-200 blocks receptor responsible for inflammation ▪ Translates to reduced inflammation and subsequent fibrosis (scarring) in the kidney2
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