Radiopharm Theranostics Limited · ASX:RAD
Radiopharm Theranostics — Corporate Update (October 2025)
43 slides from Radiopharm Theranostics's corporate update, Oct 20, 2025
Slide 1: Deck Accompanying Press Release
OCTOBER 20 th , 2025 NASDAQ: RADX / ASX: RAD DECK ACCOMPANYING PRESS RELEASE
Slide 2: Notice & Disclaimer
Notice & Disclaimer The information in this presentation does not constitute personal investment advice. The presentation is not intended to be c omp rehensive or provide all information required by investors to make an informed decision on any investment in Radiopharm Theranostics Ltd ACN 647 877 8
Slide 3: Clinical Data Update From Four Clinical Trials
PROGRAM TARGET & MOLECULE INDICATION ISOTOPE PRECLINICAL PHASE I PHASE 2A PHASE 2B NOTES RAD101 Short Chain Fatty Acid (small molecule) Brain Mets F18 Phase 2b enrolling, NCT06777433 12 patients dosed / 30 patients total Expect to complete enrollment 1Q26 RAD202 HER2 (nanobody) HER2+ solid tumors Lu
Slide 4: Molecule: 18F-RAD101
Molecule: 18F - RAD101 Targeting MoA: SHORT CHAIN FATTY ACIDS Imaging for: SUSPECTED RECURRENT BRAIN METASTASES 4
Slide 5: RAD101 Small Molecule Imaging for Brain Metastasis
RAD 101 (PIVALATE) SMALL MOLECULE Selectively targets fatty acid synthase: overexpressed in tumors but not normal brain cells Imaging for Brain Metastasis CANCER CELL TARGET Fatty acid oxidation TARGETING MOLECULE pivalate LINKER RADIOACTIVE ISOTOPE 18 F FATTY ACID SYNTHASE IS A VIABLE TARGET ✚ Upre
Slide 6: Phase 2b Trial Design
Phase 2b Trial Design Phase 2b imaging study in participants with suspected recurrent brain metastases from solid tumors IV, intravenous; MBq, megabecquerel; mCi, millicurie; MRI, magnetic resonance imaging; PET, positron emission tomography; SRS , s tereotactic radiosurgery. 6 • Study Design: Singl
Slide 7: RAD101 Diagnostic: Clinical Development
Phase 2b imaging study currently recruiting (USA)* No competitor identified; RAD 101 is the only PET agent in clinical development for Brain Mets Large total addressable market: 300,000 new subjects diagnosed every year (US only) RAD 101 DIAGNOSTIC: CLINICAL DEVELOPMENT * NCT06777433 PRECLINICAL PHA
Slide 8: Executive Summary - New Clinical Data
• RAD Phase 2b Study is currently ongoing and recruiting subjects • Images from n=3 subjects in the ongoing study demonstrate the concept by showing increased metabolic activity in areas with equivocal MRI findings (suspected relapse) • N=12 subjects dosed as of 10/20/2025; expected n=20 subjects by
Slide 9: Study Patient #1
Study Patient #1 Note: the PET of patient #1 and patient #2 have inverted gray scales. In patient #1, PET metabolic activity is black. In patient #2, activity is white MRI, magnetic resonance imaging; PET, positron emission tomography; SRS, stereotactic radiosurgery. 9 RAD 101 DIAGNOSTIC MRI shows a
Slide 10: Study Patient #2
Study Patient #2 Note: the PET of patient #1 and patient #2 have inverted gray scales. In patient #1, PET metabolic activity is black. In patient #2, activity is white MRI, magnetic resonance imaging; PET, positron emission tomography; SRS, stereotactic radiosurgery. 10 RAD 101 DIAGNOSTIC MRI shows
Slide 11: Study Patient #3
Study Patient #3 MRI with suspected relapsed brain metastasis after SRS. It is unclear if this (or how much) is active tumor or necrosis following SRS PET scans showing high metabolic activity in a significantly larger area of the brain compared to the MRI, indicative of a relapsed brain metastasis
Slide 12: Molecule: 177Lu-RAD202
Molecule: 177Lu - RAD202 Targeting MoA: HER2 Therapeutic for: HER2+ TUMORS 12
Slide 13: RAD202 HER2 Nanobody Targeting Moiety
RAD 202 Utilizes Anti - PD - L1 Nanobody as Targeting Moiety CANCER CELL TARGET HER2 TARGETING MOLECULE Sd mAb LINKER RADIOACTIVE ISOTOPE 177 Lu HER2+ THERAPY FOR subjects REFRACTORY TO TRASTUZUMAB DERUXTECAN (Enhertu ® ) Post - Enhertu ® Market Increasingly Attractive ✚ Enhertu ® moving up treatmen
Slide 14: Phase 1 Trial Design 'HEAT' Trial
Primary Objectives (Phase 1, Treatment): o Safety and tolerability of 177 Lu - RAD202 o Recommended ph2 dose of 177 Lu - RAD202 Population : Her2+ (IHC, ISH) a/m solid tumors Phase 0 Imaging: Biodistribution, PK and radiation dosimetry of 177 Lu - RAD202 im in organs of interest and tumor lesions Ph
Slide 15: Executive Summary | Current Study Status
• There are currently n=3 subjects in treatment in cohort #1 (30 mCi) with data available • DSMC on Sept 30 th , approved the start of Cohort #2 at 75mCi • Significant amount of drug uptake (absorbed radiation dose) is observed in tumor lesions (cohort #1) • The safety profile has been very favorabl
Slide 16: Lesion Dosimetry: First Patients Show Very High Tumor Uptake
Lesion Dosimetry | First 3 Patients Show Very High Tumor Uptake PATIENT #1 Absorbed Dose at 30 mCi Cycle Lesion Volume (ml) 2 Dose (Gy), with PVC 1,2 C1 ROI - 2 2.26025 3.57 C1 ROI - 3 3.634 2.07 C1 ROI - 4 10.36125 2.02 C1 ROI - 5 16.20966667 0.39 1 Partial Volume Correction applied. 2 Density of l
Slide 17: Adverse Events Summary (interim data) | Dose Level 1
Treatment Emergent and Treatment - Related Adverse Events • All TEAEs in Dose Levels 1 were CTC Grade 1 and 2 • Only two AEs (both in the same patient) were considered ‘related’ by the treating physician: Grade 1 dysgeusia and Grade 1 pleural effusion Serious Adverse Events • There were no SAEs repo
Slide 18: Molecule: 177Lu-RAD204
Molecule: 177Lu - RAD204 Targeting MoA: PD - L1 Therapeutic for: PD - L1+ TUMORS 18
Slide 19: RAD204 Utilizes Anti-PD-L1 Nanobody as Targeting Moiety
RAD 204 Utilizes Anti - PD - L1 Nanobody as Targeting Moiety RAD 204 THERAPEUTIC CANCER CELL TARGET PD - L1 TARGETING MOLECULE Sd mAb LINKER RADIOACTIVE ISOTOPE 177 Lu BENEFITS OF NANOBODIES ✚ Specificity and affinity of a full - size antibody; binds to different epitopes than approved full - sized
Slide 20: Phase 1 Trial Design
Dose Level Dose Phase 0 (Imaging Period with 177 Lu - RAD204 im ) Imaging dose 10 (0.37 GBq) Phase I (Treatment Period with 177 Lu - RAD204 tr ) Therapeutic DL1 30 mCi (1.1. GBq) DL2 60 mCi (2.2 GBq) DL3+ TBD Phase 1 Trial Design 177 Lu - anti - PD - L1 single domain AB in metastatic solid tumors 20
Slide 21: Executive Summary – Current Study Status
Executive Summary – Current Study status *One patient (Patient 003 - 009) is not DLT - evaluable (consent withdrawal due to personal reasons) NSCLC, non - small cell lung cancer; PD - 1, programmed death - 1; PDL - 1, programmed death ligand - 1; PFS, progression - free survival. • Preliminary data
Slide 22: Lesion Dosimetry | 003-001 (NSCLC)
RAD 204 THERAPEUTIC Absorbed dose at 30 mCi Cycle Lesion Volume (ml) 2 D1 SUV max SUV T:BR* Dose (Gy), with PVC 1,2 C1 Primary (left lung apex) 111.8758 3 2.8 4.36 0.18 C1 Primary - core 11.48 0.46 C1 RLL met 32.3506 3 2.95 4.57 0.23 C1 RLL met - CT 5.97 4 0.59 C1 RML met 25.6196 3 4.2 6.09 0.52 C1
Slide 23: Lesion Dosimetry (sqNSCLC)
Lesion Dosimetry | 003 - 002 (sqNSCLC) Selective uptake of 177 Lu - RAD204 in pulmonary lesions RAD 204 THERAPEUTIC Absorbed dose at 30 mCi Cycle Lesion Volume (ml) 2 D1 SUV max SUV T:BR* Dose (Gy), with PVC 1 C1 Primary (Left lung perihilar) 151.4286 4 4.54 6.16 0.16 C1 Primary – core 11.47 0.74 C2
Slide 24: Lesion Dosimetry (NSCLC)
Lesion Dosimetry | 003 - 006 (NSCLC) Selective uptake of 177 Lu - RAD204 in primary and metastatic pulmonary lesions RAD 204 THERAPEUTIC Absorbed dose at 30 mCi Cycle Lesion Volume (ml) 2 D1 SUV max SUV T:BR* Dose (Gy), with PVC 1 Im Primary (RUL) 47.3216 2.7 3.4 0.18 Im T2 43.797 3.5 4.4 0.15 C1 Pr
Slide 25: 30mCi Cohort: Preliminary Clinical Activity Exceeds Historical Controls
x Cohort 1 - 30mCi Dose Level Preliminary Clinical Activity (PFS of 5+ months) in 2/3 subjects (67%) exceeds historical controls 25 RAD 204 THERAPEUTIC 1 subjects without actionable mutations. Soon YY, et al. Clinical Trial and Real - World Outcomes of subjects With Metastatic NSCLC in the Post - Pl
Slide 26: Lesion Dosimetry | Second Cohort at 60 mCi
Lesion Dosimetry | Second Cohort at 60 mCi Data from a single administration in all three patients. RAD 204 THERAPEUTIC PATIENT #1 PATIENT #4 Absorbe d dose at 60 mCi Cycle Lesion Volume (ml) 2 D1 SUV max SUV T:BR* Dose (Gy), with PVC 1,2 C1 Primary 113 2.1 5.1 0.33 C1 Lymph node axillary left (ROI
Slide 27: Treatment-Emergent and Treatment-Related Adverse Events
Treatment - Emergent and Treatment - Related Adverse Events • Majority of TEAEs in Dose Levels 1 and 2 were CTC Grade 1 and 2 • There were a total of four Grade 3 events, all of which were pre - existing at study entry • Only one of the Grade 3 events was considered ‘related’ by the treating physici
Slide 28: Molecule: 68Ga-RAD301
Molecule: 68Ga - RAD301 Targeting MoA: αVβ6 INTEGRIN Imaging for: PANCREATIC CANCER 28
Slide 29: RAD301 (Trivehexin) Peptide
RAD 301 (Trivehexin) PEPTIDE • RGD peptide (arginylglycylaspartic acid) • Integrin αvβ6 receptor antagonist • Design features include hydrophilicity to reduce non - specific uptake into undesired organs and increase clearance in plasma, trimerization to increase affinity, cyclicity for better select
Slide 30: 80 Subjects Imaged With 68Ga-RAD301 To Date
• 44 subjects : Pancreatic Ductal Adenocarcinoma (PDAC) imaged under 3rd party (Germany) compassionate use* • 32 subjects: 12 PDAC, 20 Head & Neck Squamous Cell Carcinoma(HNSCC) imaged in Investigator Initiated Research (IIR)** • 4 subjects: single case publications in Non - Small Cell Lung Cancer (
Slide 31: Upcoming Milestones
UPCOMING MILESTONES PROGRAM 2NDHALF 2024 1STHALF 2025 2NDHALF 2025 RAD301 Phase I Phase 1 ongoing Phase 1 ongoing Last patient dosed ACHIEVED PROGRAM 1ST HALF 2026 2ND HALF 2026 1ST HALF 2027 2NDHALF 2027 RAD301 Phase 2 CLINICAL SITES EXPANSION TRIAL START ENROLLING TRIAL COMPLETED TRIAL POPULATION
Slide 32: Executive Summary RAD301 Diagnostic
Executive Summary 32 RAD 301 DIAGNOSTIC αVβ6, alpha - v beta - 6 integrin; cm, centimeter; GYN, gynecologic; n, number of subjects; RAD301, radiolabeled αVβ6 - targeted diagn ostic agent. • Phase 1 company - sponsored study underway in healthy volunteers and pancreatic cancer subjects to characteriz
Slide 33: PET/CT Scan | Pancreatic Cancer Patient
PET/CT Scan | Patient 1 Pancreatic Cancer patient with large pancreatic mass visible in PET RAD 301 DIAGNOSTIC Axial Slice 289/423 Coronal Slice 82/144 AC, attenuation corrected; PET, positron emission tomography. 33
Slide 34: PET/CT Scan | Metastatic Pulmonary Nodules
PET/CT Scan | Patient 2 Pancreatic Cancer patient with multiple bilateral metastatic pulmonary nodules ranging in size from 1.3 to 2.2. cm RAD 301 DIAGNOSTIC Axial cm, centimeter; CT, computed tomography; PET, positron emission tomography. 34
Slide 35: PET/CT Scan | Metastatic Lung Nodules <1cm
PET/CT Scan | Patient 3 Pancreatic cancer patient with multiple metastatic lung nodules <1cm RAD 301 DIAGNOSTIC Axial cm, centimeter; CT, computed tomography; PET, positron emission tomography. 35
Slide 36: Appendix
Appendix www.radiopharmtheranostics.com 36
Slide 37: Imaging and Therapeutic Trials Pipeline
PROGRAM TARGET & MOLECULE INDICATION ISOTOPE PRECLINICAL PHASE I PHASE IIA PHASE IIB NOTES IMAGING TRIALS RAD101 Short Chain Fatty Acid (small molecule) Brain Mets F18 Phase 2b enrolling, NCT06777433 Expected to be fully enrolled in Q1 2026 RAD301 Integrin [avB6] (peptide) Integrin αvβ6+ Pancreatic
Slide 38: Secured & Redundant Radioisotope Supply Chains
SECURED & REDUNDANT RADIOISOTOPE SUPPLY CHAINS FOCUS ON CLINICALLY PROVEN RADIOISOTOPES FROM EXISTING GLOBAL SUPPLY CHAINS, ENABLING SAFE & RELIABLE DISTRIBUTION Beta Particles Most used therapeutic isotope Well proven therapeutic index FDA approved for solid tumors Long half - life allows for globa
Slide 39: Revolutionizing Oncology Treatment with Radiopharmaceuticals
Revolutionizing Oncology Treatment with Radiopharmaceuticals Fully funded to achieve multiple near - term catalysts with the potential for value creation ✓ Initiated Phase I therapeutic study of RAD - 204 (PDL1) in solid tumor cancers ✓ Initiated Phase 2b imaging study of RAD - 101(Brain Mets) ✓ Ini
Slide 40: Capital Raising
CAPITAL RAISING 40
Slide 41: Capital Raising Overview
CAPITAL RAISING OVERVIEW Company is raising approximately A$40 million via a two - tranche placement and SPP Placement • A$35 million two - tranche placement comprising: ‒ A$12.5 million placement under the Company’s available placement capacity under ASX Listing Rules 7.1 and 7.1A (“ Tranche 1 ”);
Slide 42: Capital Raising and Use of Funds
CAPITAL RAISING AND USE OF FUNDS Company is raising approximately A$40 million , which it expects will fully fund its current clinical programs through multiple near - term catalysts and into 2027 SOURCE OF FUNDS A$M Existing Cash Balance 1 $19m Capital Raising 2 $40m TOTAL $59m 1 As of September 30
Slide 43: Thank You
Thank You www.radiopharmtheranostics.com 43
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