Slide 1: Phase 2 Trial Results
PHASE 2 TRIAL RESULTS ARGENICA THERAPEUTICS ASX: AGN SEPTEMBER 2025 MANAGING DIRECTOR PRESENTATION 1 www.argenica.com.au
Slide 2: Disclaimer
DISCLAIMER This presentation has been prepared by Argenica Therapeutics Limited and its related entities (the “Company”) and is not an offer document. It does not purport to contain all the information that a prospective investor may require in connection with any potential investment in the Company
Slide 3: Leading Research & Clinical Team
LEADING RESEARCH & CLINICAL TEAM Dr Meghan Thomas Prof. Bruno Meloni VP Clinical & Regulatory Development CSO & Research Lead 15 years experience in basic research, clinical trial design and Head of Stroke Laboratory Research at UWA and the Perron Institute. Professor oversight, regulatory pathways,
Slide 4: Patient & Consumer Engagement – Advisory Committee
PATIENT & CONSUMER ENGAGEMENT – ADVISORY COMMITTEE Prof Geoffrey Donnan Dr Jeffery Saver Member - CAC Member - CAC Professor of Neurology at The University of Dr Saver is Professor and Senior Melbourne and former Director of The Florey Associate Vice-Chari of Neurology at Institute of Neuroscience a
Slide 5: Overview of Phase 2 Trial Results
OVERVIEW OF PHASE 2 TRIAL RESULTS Argenica’s Phase 2 trial for ARG-007 in AIS has met its primary endpoint, missed on its overall secondary endpoint, but showed encouraging signal of efficacy in the “slow collateral” patients. KEY SUMMARY Temporal profile of Treatment-Emergent Adverse Events • Phase
Slide 6: Phase 2 Clinical Trial: Secondary Endpoint Data
PHASE 2 CLINICAL TRIAL ARGENICA THERAPEUTICS SECONDARY ENDPOINT DATA 6 www.argenica.com.au
Slide 7: Phase 2 Trial Design
PHASE 2 TRIAL DESIGN PATIENT HAS A PATIENT IN ARRIVES AT DIAGNOSE REHAB STROKE AMBULANCE HOSPITAL STROKE TYPE THROMBECTOMY BEGINS ARGENICA THERAPEUTICS Initial screening of Administration of Endpoints patients to meet inclusion 0.3mg/kg ARG-007 or Mortality rate and frequency of Adverse and Serious
Slide 8: Phase 2 Clinical Trial in Stroke
PHASE 2 CLINICAL TRIAL IN STROKE 92 patients dosed at 8 Australian ACTUAL PATIENT RECRUITMENT hospitals 100 KEY OBJECTIVES: 90 ARGENICA THERAPEUTICS 80 1. Safety/Tolerability – significantly 70 derisks the drug, critical in Patients Dosed 60 neurology drug development 50 40 2. Pharmacokinetics – is
Slide 9: Secondary Endpoint
SECONDARY ENDPOINT • Infarct volume reduction between ARG-007 and placebo at 48 hours (Day 3 ± 1 day) across all patients ARGENICA THERAPEUTICS ➢ No overall effect seen • Infarct volume reduction between ARG-007 and placebo at 48 hours (Day 3 ± 1 day) in slow collateral subgroup ➢ 15% (5mL) infarct
Slide 10: Relevance of Collateral Blood Flow in AIS Patients
RELEVANCE OF COLLATERAL BLOOD FLOW IN AIS PATIENTS1 Good Collaterals • Robust collateral blood flow maintains penumbra until EVT • High reperfusion success better functional outcomes • Neuroprotection targeting acute injury may not show benefit (tissue already protected) Slow Collaterals ARGENICA TH
Slide 11: Slow Collateral Patients – 30% of Participants
SLOW COLLATERAL PATIENTS – 30% OF PARTICIPANTS1 THE MOST AT-RISK PATIENTS OF VULNERABLE BRAIN TISSUE (PENUMBRA) TURNING TO INFARCT • Patients with slow/poor collaterals have highly vulnerable brain tissue that is not yet dead • This vulnerable tissue is where ARGENICA THERAPEUTICS injury cascades ar
Slide 12: Infarct Volume Reduction (%)
HOW MUCH BRAIN DO YOU NEED TO SAVE? CLINICALLY MEANINGFUL FINAL INFARCT VOLUME REDUCTIONS • A 0.6 mL, which equates to a 1.6% decrease in infarct 100% 1.6% volume (decrease in brain cell death), is the minimum INFARCT VOLUME REDUCTION (%) 90% Reduction amount of decrease deemed to be clinically impo
Slide 13: Summary
SUMMARY • The Phase 2 study in 92 AIS patients has yielded important and instructive information on patient selection, dosing and imaging time frames, to optimize any future AIS trial design. • Together with the robust, validated preclinical animal data which has consistently demonstrated significan
Slide 14: Appendix
APPENDIX 1 ARGENICA THERAPEUTICS REFERENCES 14 www.argenica.com.au
Slide 15: References
REFERENCES SLIDE 8 REFERENCES: • MacDougall G, Anderton RS, Trimble A, Mastaglia FL, Knuckey NW, Meloni BP. Poly-arginine-18 (R18) confers neuroprotection through glutamate receptor modulation, intracellular calcium reduction, and preservation of mitochondrial function. Seymour T, Kobeissi H, Ghozy
Slide 16: For further information please contact
ARGENICA THERAPEUTICS For further information please contact: Dr Liz Dallimore CEO & Managing Director E: info@argenica.com.au 16 www.argenica.com.au