Radiopharm Theranostics Limited · ASX:RAD
Radiopharm Theranostics — Investor Presentation (November 2025)
60 slides from Radiopharm Theranostics's investor presentation, Nov 1, 2025
Slide 1: Company Presentation November 1st, 2025
NASDAQ: RADX / ASX: RAD COMPANY PRESENTATION NOVEMBER 1st , 2025
Slide 2: Notice & Disclaimer
Notice & Disclaimer The information in this presentation does not constitute personal investment advice. The presentation is not intended to be comprehensive or provide all information required by investors to make an informed decision on any investment in Radiopharm Theranostics Ltd ACN 647 877 889
Slide 3: Investment Highlights
INVESTMENT HIGHLIGHTS Clinical Stage Company Advancing First-in-Class Radiopharmaceuticals • Five priority molecules; 4 Therapeutics (PD-L1; HER2; B7H3; KLK3) and 1 Diagnostics (Brain Mets) Secure Supply Chain • Redundant and secure radioisotopes supply chains (Lu177 & Tb161) Strategic Partnerships
Slide 4: Management Team
M A N A G E M E N T TEAM Riccardo Canevari Dr. Dimitris Voliotis Vimal Patel Dr .She r in A l- Saf adi B ar bara L ani D r .L e v en te Me sz a ros Chief Executive Officer Chief Medical Officer V P CMC V P Quality Affairs V P Preclinical V P Medical & Corp. Affairs • Radiopharm • Radiopharm Theranos
Slide 5: Chairman & Board
CHAIRMAN & B O A R D Paul Hopper Executive Chairman Ian Turner Hester Larkin Phillip Hains • Founder of Radiopharm Theranostics Ltd. • 25 years experience as a life-sciences entrepreneur • Founder, Chairman, non-executive director or C E O of more than fifteen companies in the US, Australia a n d As
Slide 6: Company Pipeline – Five first in class radiopharmaceutical molecules
Company Pipeline – Five first in class radiopharmaceutical molecules PROGRAM TARGET & MOLECULE INDICATION ISOTOPE PRECLINICAL PHASE I PHASE IIA PHASE IIB NOTES IMAGING Phase 2b in 5 US centers, NCT06777433 TRIAL Short Chain Fatty Acid RAD101 Brain Mets F18 12 patients dosed / 30 patients total (smal
Slide 7: Company Pipeline – Wave 2 assets in proof-of-concept stage
Company Pipeline – Wave 2 assets in proof-of-concept stage PROGRAM TARGET & MOLECULE INDICATION ISOTOPE PRECLINICAL PHASE I PHASE IIA PHASE IIB NOTES RAD301 Ga68 Phase 1 enrolling, NCT05799274 Dx 6 pts dosed / 9 total Integrin [avB6] Integrin αvβ6+ Pancreatic cancer (peptide) RAD 302 Lu177 Tx Molecu
Slide 8: Secured & Redundant Radioisotope Supply Chains
SECURED & REDUNDANT RADIOISOTOPE SUPPLY CHAINS FOCUS ON CLINICALLY PROVEN RADIOISOTOPES FROM EXISTING GLOBAL SUPPLY CHAINS, ENABLING SAFE & RELIABLE DISTRIBUTION 177-Lutetium 161-Terbium Beta Particles B e t a & Au g e r Particles Most used therapeutic isotope Innovative dual atomic particle functio
Slide 9: Molecule: 18F-RAD101 Brain Metastases Imaging
Molecule: 18F-RAD101 Targeting MoA: SHORT CHAIN FATTY ACIDS Imaging for: SUSPECTED RECURRENT BRAIN METASTASES 9
Slide 10: Imaging for Brain Metastasis
RAD 101 DIAGNOSTIC Imaging for Brain Metastasis RAD 101 (PIVALATE) SMALL MOLECULE Selectively targets fatty acid synthase: LINKER overexpressed in tumors but not normal brain cells CANCER CELL TARGETING RADIOACTIVE TARGET MOLECULE ISOTOPE Fatty acid oxidation pivalate 18F FATTY ACID SYNTHASE IS A VI
Slide 11: RAD101 Diagnostic: Clinical Development
RAD 101 DIAGNOSTIC: CLINICAL DEVELOPMENT Phase IIb imaging study currently recruiting in five centers in 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) PRECLINICAL
Slide 12: RAD101: Detailed Clinical Milestones
RAD101: DETAILED CLINICAL MILESTONES ACHIEVED 2ND HALF 1ST HALF 2ND HALF Q1 Q2 Q3 PROGRAM 2024 2025 2025 2026 2026 2026 Long-term Last Patient Primary follow-up RAD101 IND First Patient ~20 pts dosed Objective data secondary Phase IIb Approval dosed recruited (30/30 pts) read-out objective read-out
Slide 13: RAD101 Commercial Potential
RAD101 COMMERCIAL POTENTIAL: USD$ >500m yearly sales (USA only) Third largest imaging molecule after Pilarify (Lantheus) & Illucix (Telix) Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 13
Slide 14: Phase 2b Trial Design
RAD 101 DIAGNOSTIC Phase 2b Trial Design Phase IIb imaging study in participants with suspected recurrent brain metastases from solid tumors Eligibility Endpoints • Known history of brain metastases 10mCi RAD101 • Concordance between 6 Months (lung, breast, colon, kidney, melanoma) Whole Brain PET P
Slide 15: Clinical Data from Phase IIb
RAD 101 DIAGNOSTIC Clinical Data from Phase IIb • 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 10/01/2025; expected n=20 subjects by December; N=30/30
Slide 16: Study Patient #1
RAD 101 DIAGNOSTIC Study Patient #1 MRI shows a suspected relapsed brain metastasis PET shows dark spot of high metabolic activity in the same location, after SRS (see reticle) increasing the possibility of this being a metastasis relapse MRI PET Note: the PET of patient #1 and patient #2 have inver
Slide 17: Study Patient #2
RAD 101 DIAGNOSTIC Study Patient #2 MRI shows a suspected relapsed brain metastasis after PET shows high metabolic activity (white ring) surrounding a dark SRS (see reticle). It is unclear if this is active tumor or necrotic area (cavity) which is strongly indicative of a relapsed necrosis following
Slide 18: Study Patient #3
Study Patient #3 MRI with suspected relapsed brain metastasis PET scans showing high metabolic activity in a much larger area of the after SRS. It is unclear if this (or how much) is brain compared to the MRI, strongly indicative of a relapsed brain active tumor or necrosis following SRS metastasis
Slide 19: Molecule: 177Lu-RAD204 PD-L1
Molecule: 177Lu-RAD204 Targeting MoA: PD-L1 Therapeutic for: PD-L1+ TUMORS 19
Slide 20: RAD204 utilizes an anti-PD-L1 Nanobody as a targeting moiety
RAD 204 THERAPEUTIC RAD 204 utilizes an anti-PD-L1 Nanobody as a targeting moiety Anti-PD-L1 Nanobody High affinity single domain monoclonal antibody PD-L1 Immune Checkpoint LINKER • Antigen expression mediates evasion of immune responses by cancer cells CANCER CELL TARGETING RADIOACTIVE TARGET MOLE
Slide 21: Phase 1 Trial Design
RAD 204 THERAPEUTIC Phase 1 Trial Design 177Lu-anti-PD-L1 single domain AB in metastatic solid tumors Primary Objectives Dose Level Dose o Safety and tolerability of 177Lu-RAD204 o Recommended ph2 dose of 177Lu-RAD204tr Phase 0 (Imaging Period with Imaging dose 10 (0.37 GBq) Study Design 177Lu-RAD20
Slide 22: Clinical Data – Current Study Status
RAD 204 THERAPEUTIC Clinical data– Current Study status • RAD is currently evaluating subjects at the second dose level (60mCi). Preliminary data are available from n=3 subjects in cohort #1 (30mCi) and n=3* subjects from cohort #2 (60mCi) • DSMC meeting planned end of October / beginning of Novembe
Slide 23: Lesion Dosimetry | Patient #1 (NSCLC)
RAD 204 THERAPEUTIC Lesion Dosimetry | Patient #1 (NSCLC) Selective uptake of 177Lu-RAD204 in primary and metastatic pulmonary lesions Absorbed dose at 30 mCi C1 SUV 7 RLL Volume Dose (Gy), Cycle Lesion D1 SUVmax SUV T:BR* 6 (ml)2 with PVC1,2 Primary (left C1 111.87583 2.8 4.36 0.18 5 lung apex) Pri
Slide 24: Lesion Dosimetry | Patient #2 (sqNSCLC)
RAD 204 THERAPEUTIC Lesion Dosimetry | Patient #2 (sqNSCLC) Selective uptake of 177Lu-RAD204 in pulmonary lesions Absorbed dose SUV 7 at 30 mCi Volume Dose (Gy), Cycle Lesion D1 SUVmax SUV T:BR* 6 (ml)2 with PVC1 Primary (Left C1 151.42864 4.54 6.16 0.16 5 lung perihilar) 4 C1 Primary – core 11.47 0
Slide 25: Lesion Dosimetry | Patient #3 (NSCLC)
RAD 204 THERAPEUTIC Lesion Dosimetry | Patient #3 (NSCLC) Selective uptake of 177Lu-RAD204 in primary and metastatic pulmonary lesions Absorbed dose Average at 30 mCi Absorbed dose at 30 mCi Volume Dose (Gy), Cycle Lesion D1 SUVmax SUV T:BR* Dose (Gy), (ml)2 with PVC1 Patients with PVC1 Im Primary (
Slide 26: Cohort 30mCi Dose Level Swimmer Plot
RAD 204 THERAPEUTIC Cohort 1 - 30mCi Dose Level Preliminary Clinical Activity (PFS of 5+ months) in 2/3 subjects (67%) exceeds historical controls RAD204 – Swimmer Lane Plot 003-006_(DL1/30mCi/1.1GBq) Event Type Stable disease (SD) Participant Dose Disease Progression xNSCLC Last Line Historical Pro
Slide 27: Lesion Dosimetry | Second Cohort at 60 mCi
RAD 204 THERAPEUTIC Lesion Dosimetry | Second Cohort at 60 mCi Data from a single administration in all three patients. Absorbe Absorbed Average PATIENT #4 d dose PATIENT #5 dose Absorbed dose at 60 mCi at 60 mCi at 60 mCi Volume D1 SUV Dose (Gy), Volume D1 SUV Dose (Gy), Dose (Gy), Cycle Lesion Cyc
Slide 28: Lesion Dosimetry | Overview
RAD 204 THERAPEUTIC Lesion Dosimetry | Overview COHORT#1 COHORT#2 180 4 Average Average Absorbed dose Absorbed dose 160 3.5 at 30 mCi at 60 mCi 140 Dose (Gy), Dose (Gy), 3 Patients Patients with PVC1 with PVC1 120 2.5 Lu177 mCi Tumor Gy #1 0.56 #4 1.0 100 2 80 1.4 #2 0.45 #5 0.5 60 1.5 60 1 #3 0.21
Slide 29: Adverse Events Summary (interim data) | Dose Levels 1 and 2
RAD 204 THERAPEUTIC Adverse Events Summary (interim data) | Dose Levels 1 and 2 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
Slide 30: Molecule: 177Lu-RAD202 HER2
Molecule: 177Lu-RAD202 Targeting MoA: HER2 Therapeutic for: HER2+ TUMORS 30
Slide 31: RAD202 utilizes an anti-HER2 Nanobody as a targeting moiety
RAD 202 THERAPEUTIC RAD 202 utilizes an anti-HER2 Nanobody as a targeting moiety HER2 NANOBODY High specificity & affinity single-domain antibody • HER2 pathway well validated • Overexpression in breast, and LINKER gastroesophageal cancers • Improved tumor penetration, accumulation and CANCER CELL T
Slide 32: Phase 1 Trial Design
RAD 202 THERAPEUTIC Phase 1 Trial Design ‘HEAT’ Trial (HER2 Antibody Therapy with Lutetium-177) in subjects with HER2+ advanced solid tumors Primary Objectives (Phase 1, Treatment): Dose Level Dose o Safety and tolerability of 177Lu-RAD202 o Recommended ph2 dose of 177Lu-RAD202 Phase 0 (Imaging Peri
Slide 33: Clinical Data | Current Study Status
RAD 202 THERAPEUTIC Clinical Data| Current Study Status • Currently n=3 subjects have completed treatment in cohort #1 (30 mCi), with data available • DSMC approved the start of Cohort #2 at 75mCi • Significant amount of drug uptake (absorbed radiation dose) is observed in tumor lesions (cohort #1)
Slide 34: Lesion Dosimetry | First Patients Show Very High Tumor Uptake
RAD 202 THERAPEUTIC Lesion Dosimetry | First 3 Patients Show Very High Tumor Uptake Absorbed Absorbed Absorbed SUV 7 PATIENT #1 Dose PATIENT #2 Dose PATIENT #3 Dose at 30 mCi at 30 mCi at 30 mCi Volume Dose (Gy), Dose (Gy), Lesion 6 Cycle Lesion Cycle Lesion Volume (ml) (refer to Viedoc Volume Dose
Slide 35: Adverse Events Summary (interim data) | Dose Level 1
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 effusi
Slide 36: Molecule: RV01/BetaBart B7H3
Molecule: RV01/BetaBart Targeting MoA: B7H3 Therapeutic for: Multiple Tumor Types 36
Slide 37: RV01 (BetaBart)
RV01 (BETABART) First in class selective B7H3 radiopharmaceutical in development BETABART® Isoform-selective targeting of 4Ig-B7-H3 for PET imaging and Beta-Radioligand Therapy LINKER CANCER CELL TARGET TARGETING RADIOACTIVE 4Ig-B7H3 MOLECULE ISOTOPE 1 7 7 Lu mAb Therapy Multi-indication potential i
Slide 38: B7H3 - Highly Attractive Pan-Tumor Target
B7H3 - Highly Attractive Pan-Tumor Target 38
Slide 39: BetaBart: Deliberately Designed
BETABART: Deliberately Designed Fc MUTATIONS INTRODUCED TO REDUCE AFFINITY for FcRn AND FcγR TO ACCELERATE BLOOD CLEARANCE AND DECREASE MARROW EXPOSURE BETABART® 56% SURVIVAL WITH SINGLE INJECTION AFTER 100 DAYS muFcRn muFcR Scheme Reproduced from Bioconjugation Techniques (2013) 39
Slide 40: BetaBart Preclinical Efficacy
BETABART Preclinical Efficacy ADAPTIVE IMMUNE SYSTEM IN TUMOR MICROENVIRONMENT PLAYS KEY SUPPORTIVE ROLE IN RESPONSE TO THERAPY THERAPEUTIC EFFICACY OF I.V. 90Y-DOTA- IN VIVO IMMUNE CELL DEPLETION MIL33B RELIES ON CD8B+ CELLS 40
Slide 41: BetaBart Preclinical Efficacy: Immunological Memory
BETABART Preclinical Efficacy IMMUNOLOGICAL MEMORY (TUMOR REJECTION) LONG-TERM SURVIVORS WITH 90Y-DOTA-MIL33B RECHALLENGE SURVIVAL: PRE-TREATED RECHALLENGED WITH CT26 TUMOR CELLS SURVIVORS VERSUS TREATMENT-NAIVE MICE CT26 hB7-H3 90Y-DOTA-MIL33B(n = 4) 100 CT CT26 hB7-H3 naive (n=6) 80 CT Percent sur
Slide 42: In-Vivo Biodistribution of 177Lu-BetaBart
In-Vivo Biodistribution of 177Lu-BetaBart Specific Tumor Targeting Biodistribution By Design WT KO Block ✓ High tumor uptake ✓ Liver excretion ✓ Very low kidney uptake Heart (Blood) Tumor SPECT-CTs @24h 42 WT = wild-type HeLa cells with hu 4Ig expression; KO = B7-H3 gene knockout; Block = excess col
Slide 43: BetaBart Key Milestones
BETABART K E Y M I L E S T O N E S • Phase I therapeutic trial IND received in July 2025 • Basket Phase I therapeutic trial to start by the end of 2025 TARGET & 2ND HALF 1ST HALF 2ND HALF 1ST HALF PROGRAM INDICATION Dx/Tx ISOTOPE MOLECULE 2024 2025 2025 2026 IND B7-H3 approval PRE-IND IND First two
Slide 44: Molecule: RAD402 – 161Tb KLK3 Prostate Cancer
Molecule: RAD 402 – 161Tb Targeting MoA: KLK3 Therapeutic for: PROSTATE CANCER 44
Slide 45: RAD402 KLK3 Targeting
RAD 402 KLK3 TARGETING Monoclonal Antibody Exquisite Anatomical & Disease Specificity Targeting Prostate Kallikrein Versus Traditional Prostate Cancer Targets • hu5A10 is a humanized IgG1 internalized by prostate cells, specifically binding to catalytically active PSA/KLK3 (not found in blood circul
Slide 46: RAD402 - In Vivo Findings SPECT Biodistribution (Mice)
RAD 402 - In Vivo Findings SPECT Biodistribution (Mice) • SPECT imaging showed RAD 402 concentration within the heart and lungs at the first time point (4 h) and greatest signal retention in the tumor at the later time points (D2 to D8) • 161Tb-RAD400 showed good tumor uptake and retention up to 8 d
Slide 47: RAD402 - In Vivo Findings
RAD 402 - In Vivo Findings SPECT Derived In Vivo Biodistribution (Mice) T1/2=7d SPECT-derived tumor activity concentration Activity uptake in blood between 4 h and 192 h p.i. 47
Slide 48: RAD402: Key Milestones
RAD 402: KEY MILESTONES • Ethics Committee submission planned for Q4 2025 • Phase I therapeutic trial 2H in Australia to start in Q4 2025 TARGET & 2ND HALF 1ST HALF 2ND HALF PROGRAM INDICATION Dx/Tx ISOTOPE MOLECULE 2024 2025 2025 Ethics Committee KLK3 Approval RAD402 PROSTATE Therapy Tb161 BioD & T
Slide 49: Thank You
Thank You www.radiopharmtheranostics.com 49
Slide 50: Appendix
Appendix
Slide 51: Radiopharm + MD Anderson Joint Venture Created in 2022
RADIOPHARM + MD ANDERSON JOINT VENTURE CREATED IN 2022 Mandate: Develop novel radiopharmaceutical therapies Main Achievements 2023 2024 2025 B7H3 mAb (RV01) Double Fc- IND enabling IND clearance mutation studies completed received for B7H3 introduced & First patient dose expected Undisclosed (RV02)
Slide 52: Molecule: 68Ga-RAD301 αVβ6 Integrin
Molecule: 68Ga-RAD301 Targeting MoA: αVβ6 INTEGRIN Imaging for: PANCREATIC CANCER 52
Slide 53: Imaging for Pancreatic Cancer
RAD 301 DIAGNOSTIC Imaging for Pancreatic Cancer 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 LINKER increase clearance in plasma, trimeriza
Slide 54: 80 Subjects Imaged with 68Ga-RAD301 to Date
RAD 301 DIAGNOSTIC 80 Subjects Imaged with 68GA-RAD301 to Date Multi-indication Potential Beyond Pancreatic Cancer • 44 subjects: Pancreatic Ductal Adenocarcinoma (PDAC) 3rd PARTY IIR IN PDAC & imaged under 3rd party (Germany) compassionate use* HNSCC** + COMPASSIONATE PHASE I (USA)*** Phase II (USA
Slide 55: RAD301 Congress presentation and publications of FIH data
R A D 301 C ongr e ss presentation a n d publications of F I H data 68Ga-trivehexin PET/MRI I m a g i n g subjects 6 8 G a - t r i v e h e x i n P E T / C T I m a g i n g v s F18-F D G with Pancreatic Tumors • Detection of αvβ6 integrin-expressing tumor lesions in subjects with PDAC • Selective dete
Slide 56: Upcoming Milestones
UPCOMING MILESTONES ACHIEVED 2ND HALF 1ST HALF 2ND HALF TRIAL POPULATION PROGRAM Metastatic Pancreatic Cancer 2024 2025 2025 - Adequate for proof of concept RAD301 Phase I Phase I Last patient - subjects with more extensive disease, more frail, Phase I ongoing ongoing dosed difficult to recruit - Li
Slide 57: Clinical Data
RAD 301 DIAGNOSTIC Clinical Data • Phase 1 company-sponsored study underway in healthy volunteers and pancreatic cancer subjects to characterize biodistribution, image quality and organ/tumor dosimetry • Preliminary results from n=3 subjects in RADs ongoing study thus far suggest high sensitivity fo
Slide 58: PET/CT Scan | Patient 09
RAD 301 DIAGNOSTIC PET/CT Scan | Patient 09 Pancreatic Cancer patient with large pancreatic mass visible in PET Axial Coronal Slice 289/423 Slice 82/144 AC, attenuation corrected; PET, positron emission tomography. 58
Slide 59: PET/CT Scan | Patient 15
RAD 301 DIAGNOSTIC PET/CT Scan | Patient 15 Pancreatic Cancer patient with multiple bilateral metastatic pulmonary nodules ranging in size from 1.3 to 2.2. cm Axial cm, centimeter; CT, computed tomography; PET, positron emission tomography. 59
Slide 60: PET/CT Scan | Patient 16
RAD 301 DIAGNOSTIC PET/CT Scan | Patient 16 Pancreatic cancer patient with multiple metastatic lung nodules <1cm Axial cm, centimeter; CT, computed tomography; PET, positron emission tomography. 60
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