Radiopharm Theranostics Limited · ASX:RAD
Radiopharm Theranostics — Investor Presentation (December 2025)
60 slides from Radiopharm Theranostics's investor presentation, December 2025
Slide 1: Company Presentation December 2025
NASDAQ: RADX / ASX: RAD COMPANY PRESENTATION DECEMBER 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: Investments Highlights
Investments 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
Management Team Riccardo Canevari Dr .She r in A l- Saf adi Vimal Patel B ar bara L ani D r .L e v en te Me sz a ros Dr. Dimitris Voliotis V P CMC V P Quality Affairs V P Preclinical V P Medical & Corp. Affairs CEO CMO • Radiopharm • Radiopharm Theranostics C E O Theranostics CMO since September sin
Slide 5: Chairman and Board
Chairman and Board Paul Hopper Executive Chairman Ian Turner Hester Larkin Noel Donnelly • 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 Asia
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 Short Chain Fatty IMAGING Phase 2b in 5 US centers, NCT06777433 TRIAL RAD101 Acid Brain Mets F18 12-patient interim analysis released (12/’2
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 IMAGING RAD301 Ga68 Phase 1 enrolling, NCT05799274 Integrin αvβ6+ Tumors 7 pts dosed / 9 total Integrin [avB6] Pancreatic cancer / (peptide) NSCLC RAD
Slide 8: Secured and Redundant Radioisotope Supply Chain
Secured and Redundant Radioisotope Supply Chain 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 functi
Slide 9: Molecule: 18F-RAD101 – Imaging for Suspected Recurrent Brain Metastases
RAD 101 DIAGNOSTIC 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 Imaging: Clinical Development
RAD 101 DIAGNOSTIC RAD 101 Imaging: Clinical Development Phase IIb imaging study currently recruiting in five centers in USA; 50% enrollment achieved. No competitor identified; RAD 101 is the only PET agent in clinical development for Brain Mets Large Total addressable market: 300,000 new subjects d
Slide 12: 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 13: Clinical Data from Phase IIb
RAD 101 DIAGNOSTIC Clinical Data from Phase IIb • Interim analysis in 12 patients in the ongoing study released (Dec 2025) • 11/12 patients (92%) achieved the primary endpoint (Concordance with MRI), with increased metabolic activity in areas with equivocal MRI findings (suspected relapse) • N=15 su
Slide 14: Subject #1 Visit 1 - Oct'25
Subject #1 Visit 1 - Oct’25 Concordance between MRI (contrast uptake plus perilesional hypodensity) & PET (tracer uptake) MRI RAD 101 PET
Slide 15: Subject #1 MRI Visit 1 vs Long 1
Subject #1 MRI Visit 1 (Oct’25) vs Long 1 (Nov’25) MRI MRI
Slide 16: Subject #1 scan dates
Subject #1 scan dates: 1/25; 9/25;10/25;11/25 Concordance between MRI (contrast uptake plus perilesional hypodensity) & PET (tracer uptake) MRI MRI MRI MRI RAD 101 PET Pre-SRS Post SRS Study Day L1 Study Day
Slide 17: Subject #2
Subject #2 (Concordance between MRI and strong tracer uptake) RAD 101 PET
Slide 18: Subject #3 Visit 1 Sep'25 MRI & PET
Subject #3 Visit 1 Sep’25 MRI & PET (Concordance between MRI and strong tracer uptake) RAD 101 MRI PET
Slide 19: Subject #4 Longitudinal 1 and 2
Subject #4 Longitudinal1 (Aug’25) and 2 (Oct’25) PET positive at Study Date; MRI Progression at Longitudinal 2 (4 months post study) MRI RAD 101 MRI MRI PET MRI D1 PET D1 L1 L2
Slide 20: Subject #5 Visit 1 Aug'25 MRI & PET
Subject #5 Visit 1 Aug’25 MRI & PET (Concordance between MRI and strong tracer uptake) RAD 101 MRI PET
Slide 21: Subject #6 No Active Tumor Detected on PET
Subject #6 No Active Tumor Detected on PET MRI RAD 101 PET
Slide 22: Next Steps
RAD 101 DIAGNOSTIC Next Steps Phase IIb • Trial completion N=30/30 pts by Q1 2026 • Phase 2b primary endpoint readout in the first half of 2026 Phase III • FDA Meeting to align on Phase III - mid 2026 • Phase III start – Q4 2026 22
Slide 23: RAD101 Commercial Potential: USD$ >500m yearly sales
RAD 101 DIAGNOSTIC 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 23
Slide 24: Molecule: 177Lu-RAD204 – PD-L1+ Tumors
RAD 204 THERAPEUTIC Molecule: 177Lu-RAD204 Targeting MoA: PD-L1 Therapeutic for: PD-L1+ TUMORS 24
Slide 25: 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 26: Phase 1 Trial Design
RAD 204 THERAPEUTIC Phase 1 Trial Design 177Lu-anti-PD-L1 single domain AB in metastatic solid tumors Dose Level Dose Primary Objectives o Safety and tolerability of 177Lu-RAD204 Phase 0 o Recommended ph2 dose of 177Lu-RAD204tr (Imaging Period with Imaging dose 10 (0.37 GBq) 177Lu-RAD204 ) Study Des
Slide 27: Clinical data Phase I
RAD 204 THERAPEUTIC Clinical data Phase I • First (30mCi) and Second Cohort (60mCi) completed, and 6 patient data released. • Tumor uptake confirmed in all the treated subjects. No tumor reduction above 30% achieved at the first two dose levels • The safety profile has been very favorable, with few
Slide 28: Tumor Uptake | Significant increase at DL2 vs DL1
RAD 204 THERAPEUTIC Tumor Uptake| Significant increase at DL2 vs DL1 COHORT#1 COHORT#2 180 4 160 3.5 Average Average Absorbed dose Absorbed dose 140 at 30 mCi at 60 mCi 3 120 Dose (Gy), Dose (Gy), 2.5 Lu177 mCi Patients Patients Tumor Gy with PVC1 with PVC1 100 90 2 #1 0.56 #4 1.0 80 1.4 60 1.5 60 #
Slide 29: Tumor Uptake | Up to 3 Gy at 60 mCi
RAD 204 THERAPEUTIC Tumor Uptake| Up to 3 Gy at 60 mCi 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 Cycle Lesion Patients (ml)2 SUVmax T:BR* with PVC1,2 (ml)2 SUVmax T:
Slide 30: Adverse Events Summary | 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 31: Molecule: 177Lu-RAD202 – HER2+ Tumors
RAD 202 THERAPEUTIC Molecule: 177Lu-RAD202 Targeting MoA: HER2 Therapeutic for: HER2+ TUMORS 31
Slide 32: 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 33: 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 34: Clinical Data Phase I
RAD 202 THERAPEUTIC Clinical Data Phase I • First Cohort completed (30 mCi), with 3 Patient data released • Significant tumor uptake observed • The safety profile very favorable, with few low-grade adverse events and no SAEs observed thus far • Currently recruiting Cohort #2 at 75mCi 1Zhao et al, Br
Slide 35: Tumor Uptake | Very High Uptake in the First 3 Patients
RAD 202 THERAPEUTIC Tumor Uptake| Very High Uptake in the First 3 Patients Absorbed Absorbed Absorbed SUV PATIENT #1 Dose PATIENT #2 Dose PATIENT #3 Dose at 30 mCi at 30 mCi at 30 mCi Volume Dose (Gy), Dose (Gy), Lesion Cycle Lesion Cycle Lesion Volume (ml) (refer to Viedoc Volume Dose (Gy), (ml)2 w
Slide 36: Adverse Events Summary | 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 37: Molecule: RV01/BetaBart – B7H3 Multiple Tumor Types
RV01 THERAPEUTIC RAD 202 utilizes an anti-HER2 Nanobody as a targeting moiety Molecule: RV01/BetaBart Targeting MoA: B7H3 Therapeutic for: Multiple Tumor Types 37
Slide 38: Betabart: first in class B7H3 targeting mAb
RV 01 THERAPEUTIC RAD 204(Betabart) RV 01 utilizes an anti-PD-L1 Nanobody first in class as aB7H3 selective targeting moiety development in clinical Picomolar affinity for 4Ig - B7H3 Soluble, blood circulating 2Ig-B7H3 isoform acts as a potential pseudo- target decoy (sink) LINKER CANCER CELL TARGET
Slide 39: B7H3 - Highly Attractive Pan-Tumor Target
RV 01 THERAPEUTIC Clinical data– Current Study status B7H3 - Highly Attractive Pan-Tumor Target 39
Slide 40: Betabart: Fc-mutated mAb With Strong Preclinical Efficacy
RV01 THERAPEUTIC Betabart: Fc-mutated mAb With Strong Preclinical Efficacy BETABART® 56% SURVIVAL WITH SINGLE INJECTION AFTER 100 DAYS Scheme Reproduced from Bioconjugation Techniques (2013) ✚ Reduced affinity for FcRn Faster hepatic excretion (no re-circulation) ✚ Reduced affinity for FcγR Reduced
Slide 41: Preclinical Efficacy – Immunological Memory
RV01 THERAPEUTIC Preclinical Efficacy – Immunological Memory 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 survival 60
Slide 42: In-Vivo Biodistribution of 177Lu-BetaBart
RV01 THERAPEUTIC In-Vivo Biodistribution of 177Lu-BetaBart Specific Tumor Targeting WT KO Block Biodistribution By Design ✓ 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; B
Slide 43: RV01 (Betabart) Key Milestones
RV01 THERAPEUTIC RV01 (Betabart) Key Milestones ACHIEVED 1. Phase I therapeutic trial IND received in July 2025 Future Milestone 2. Basket Phase I therapeutic trial to start by the end of 2025 3. First Two Cohorts data release in mid 2026 TARGET & 2ND HALF 1ST HALF 2ND HALF 1ST HALF PROGRAM INDICATI
Slide 44: Molecule: RAD402 – 161Tb KLK3 Prostate Cancer
RAD402 THERAPEUTIC RAD 202 utilizes an anti-HER2 Nanobody as a targeting moiety Intellectual Property Molecule: RAD 402 – 161Tb Targeting MoA: KLK3 Therapeutic for: PROSTATE CANCER 44
Slide 45: RAD402 first in class KLK3 mAb
RAD402 THERAPEUTIC RAD RAD204 utilizes 402 firstan in anti-PD-L1 class KLK3 Nanobody as mAb targeting a targeting moiety Humanized IgG1 Specifically binding KLK3 High affinity LINKER CANCER CELL TARGETING RADIOACTIVE Internalized by Prostate Cells TARGET MOLECULE ISOTOPE KLK3 mAb 161Tb UNIQUE BENEFI
Slide 46: RAD402 – mAb targeting KLK3 in Prostate Cancer
RAD402 THERAPEUTIC RAD 402 – mAb targeting KLK3 in Prostate Cancer KLK3 is expressed only in the prostate. PSMA has more off-target affinity 1. RAD 402 is a humanized IgG1 internalized by prostate cells, KLK3 specifically binding KLK3 with high affinity PSMA 2. RAD 402 has highly specific expression
Slide 47: RAD402 - In Vivo Findings (SPECT BioD in Mice)
RAD402 THERAPEUTIC RAD 402 - In Vivo Findings (SPECT BioD in 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 retentio
Slide 48: RAD402 - In Vivo Findings (SPECT BioD in Mice)
RAD402 THERAPEUTIC RAD 402 - In Vivo Findings (SPECT BioD in Mice) SPECT-derived tumor activity concentration Activity uptake in blood between 4 h and 192 h p.i. 48
Slide 49: RAD402 – Key Milestones
RAD402 THERAPEUTIC RAD 402 – Key Milestones 1. Ethics Committee received in November 2025 2. Phase I therapeutic trial in Australia to start in Q4 2025 3. First Two Cohorts data release in mid 2026 TARGET & 2ND HALF 1ST HALF 2ND HALF 1ST HALF PROGRAM MOLECULE INDICATION Dx/Tx ISOTOPE 2024 2025 2025
Slide 50: Thank You
Thank You www.radiopharmtheranostics.com 50
Slide 51: Appendix
Appendix z= RAD RADIOPHARM THERANOSTICS, 51
Slide 52: 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 53: Molecule: 68Ga-RAD301 – Pancreatic Cancer Imaging
Molecule: 68Ga-RAD301 Targeting MoA: αVβ6 INTEGRIN Imaging for: PANCREATIC CANCER 53
Slide 54: 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 55: 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 56: 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 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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