Radiopharm Theranostics Limited · ASX:RAD
Radiopharm Theranostics — Investor Presentation (August 2025)
61 slides from Radiopharm Theranostics's investor presentation, August 2025
Slide 1: Radiopharm Theranostics August 2025
NASDAQ: R A D X / ASX: R A D A u g u s t 2025
Slide 2: Notice & Disclaimer
Notice & Disclaimer T h e informa tion in this pres enta tion d o e s n o t constitute p ers onal in v e s t m en t advice. T h e pres enta tion is n o t i n t e n d ed to b e c o m p r eh e n s iv e or provide all informatio n req uired b y investors to m a k e a n in for med d ecisio n o n a n y i
Slide 3: Our Mission
OUR MISSION F ocused on developing breakthrough therapeutics and diagnostics to help oncology patients live longer and better
Slide 4: Investment Highlights
INVESTMENT HIGHLIGHTS Clinical Stage Company Advancing Compelling First in Class Radiopharmaceuticals • Five ongoing trials; 3 Therapeutics (PD-L1; HER2; B7H3) and 2 Diagnostics (FASN; AvB6) Promising Therapeutic Molecules • Two molecules (KLK3; AvB6) in late-stage preclinical development Secure Sup
Slide 5: Company Pipeline – Clinical Trials
C O M P A N Y P I P E L I N E – 5 Clinical Trials PROGRAM TARGET & INDICATION ISOTOPE PRECLINICAL PHASE I PHASE IIa PHASE IIb NOTES MOLECULE RAD204 PD-L1 PD-L1+ solid tumors P h a s e 1 enrolling, N C T 0 6 3 0 5 9 6 2 (nanobody) Lu177 First t w o cohor ts d a t a b y Q 3 2025 THERAPEUTIC RAD202 HER
Slide 6: Secured & Redundant Radioisotope Supply Chains
S E C UR E D & REDUNDANT RADIOISOTOPE SUPPLY CHAINS FOCUS O N CLINICALLY A N D PRE-CLINICALLY PROVEN RADIOISOTOPES F R O M EXISTING G L O B A L S U P P L Y CHAINS, E N A B L I N G S A F E & R E L I A B L E DISTRIBUTION 177-L u t e t i u m 161-T e r b i u m B e t a Pa r t i c l e s B e t a & A u g e
Slide 7: Molecule: 177Lu-RAD204 Targeting PD-L1
Molecule: 177Lu-R A D 2 0 4 T a r g e t i n g MoA: P D - L1 The r a pe utic for: P D - L1+ T U M O R S 7
Slide 8: RAD204 Therapeutic: Anti-PD-L1 Nanobody
RAD204 THERAPEUTIC Anti-PD-L1 NANOBODY A n t i - P D - L1 N a n o b o d y S i n g l e d o m a i n m o n o c l o n a l a nti bo dy ( S d m A b ) P D - L1 I m m u n e C h e c k p o i n t P r o t e i n • A n t i g e n expression m e d i a t e s evasion of i m m u n e r es po ns es b y c a n c e r cells
Slide 9: RAD204 Therapeutic: Anti-PD-L1 Nanobody Clinical Development
RAD 204 THERAPEUTIC: anti-PD-L1 NANOBODY CLINICAL DEVELOPMENT Three imaging studies with Tc99-labeled RAD204 completed.1,2,3 Phase I therapeutic dose escalation ongoing in Australia: Non-Small Cell Lung Cancer (NSCLC); Small Cell Lung Cancer (SCLC); Triple Negative Breast Cancer (TNBC); Melanoma; He
Slide 10: RAD204 Imaging Study in NSCLC - Proof of Concept
R A D 2 0 4 IMA G IN G S T U D Y I N N S C L C - P R O O F O F C O N C E P T 99Tc-RAD204 is a safe diagnostic with no reported adverse reactions, delivering a low tolerable radiation dose, showing favorable biodistribution and image characteristics correlating with PD-L1 IHC in NSCLC patients 1 • T
Slide 11: RAD204 Therapeutic: Phase 1 Trial Design
RAD 204 THERAPEUTIC: PHASE 1 TRIAL DESIGN 177Lu-anti-PD-L1 SINGLE DOMAIN AB IN METASTATIC SOLID TUMORS D os e Level Dose Phase 0 Primary Objectives ( I m a g i n g P e r i o d w i th 1 7 7 Lu-R A D 2 0 4 im) Imaging o Safety a n d tolerability of 1 7 7 Lu-R A D 2 0 4 tr dose 10 (0.36 G B q ) o R e c
Slide 12: RAD204: Key Milestones
R A D 204: K E Y M I L E S T O N E S TARGET & 1ST H A L F 2ND HALF 1ST H A L F 2ND HALF 1ST H A L F PROGRAM INDICATION Dx/ T x ISOTOPE MOLECULE 2024 2024 2025 2025 2026 First patient treated P D - L1 P D - L1+ Phase 1 RAD204 SOLID 2 cohorts 2 cohorts NCT06305962 Therapy Lu177 read-out (nano body ) T
Slide 13: Molecule: 177Lu-RAD202 Targeting HER2
Molecule: 177Lu-R A D 2 0 2 T a r g e t i n g MoA: H E R 2 The r ape utic for: H E R 2 + T U M O R S 13
Slide 14: RAD202 Therapeutic: Anti-HER2 Nanobody
R A D 202 T H E R A P E U T I C Anti-HER2 NANOBODY HER2 NANOMAB S i n g l e d o m a i n m o n o c l o n a l a nti bo dy ( S d m A b ) • H E R 2 p a t h w a y well-validated in o nco l o gy • Overexpression in breast a n d LINKER CANCER CELL g a s t r o e s o p h a g e a l ca ncer s TARGET TARGETING
Slide 15: RAD202 Therapeutic: Anti-HER2 Nanobody Clinical Development
RAD 202 THERAPEUTIC: anti-HER2 NANOBODY CLINICAL DEVELOPMENT Three imaging studies with Tc99-labeled RAD 202 completed1,2,3 Phase I therapeutic dose escalation approved for study start (Dec 2024) in Australia: HER2+ expressing advanced solid tumors (e.g. Breast, Gastric, Colorectal, Endometrial, Cer
Slide 16: RAD202 Imaging in Breast Cancer - Proof of Concept
RAD202 IMAGING IN BREAST CANCER - PROOF OF CONCEPT 99Tc-RAD202 is safe diagnostic with no reported adverse reactions. Delivers a low tolerable radiation dose and presents favorable biodistribution and image characteristics correlating with HER2 IHC in Breast Cancer patients 1,2 99T c - R A D 2 0 2 S
Slide 17: RAD202 Therapeutic: Phase 1 Trial Design
RAD 202 THERAPEUTIC: PHASE 1 TRIAL DESIGN ‘ H E A T ’ Trial ( H E R 2 A n t i b o d y T h e r a p y w i t h L u t e t i u m - 177) i n p a t i e n t s w i t h H E R 2 + a d v a n c e d solid tumors P r i m a r y O b j e c t i v e s ( P h a s e 1, Treatment): Phase 0 D os e Level Dose ( I m a g i n g
Slide 18: RAD202: Key Milestones
RAD 202: KEY MILESTONES TARGET & 1ST H A L F 2ND HALF 1ST H A L F 2ND HALF 1ST H A L F 2ND HALF PROGRAM INDICATION Dx/ T x ISOTOPE MOLECULE 2024 2024 2025 2025 2026 2026 HER2 HER2+ Preclinical Phase 1 RAD202 SOLID Therapy Lu177 2 Cohorts 2 Cohorts studies Ethics First patient last patient (Nano body
Slide 19: Molecule: RV01/BetaBart Targeting B7H3
Molecule: RV01/ Bet aBart T a r g e t i n g MoA: B 7 H 3 Ther ape ut i c for: Multiple T u m o r T y p e s
Slide 20: Radiopharm + MD Anderson Joint Venture with Broad Scope
RADIOPHARM + MD ANDERSON JOINT VENTURE WITH BROAD SCOPE RADIOPHARM V E N T U R E S LLC Ma n d ate : D e v e l o p novel r a di o pha r ma ceuti ca l therapies Preclinical a n d P h a s e I Intellectual Property 4 molecules, R&D, Preclinical, Manufacturing Management team, Regulatory strategy, Clinic
Slide 21: 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 Betabart Therapy Multi-indication potent
Slide 22: B7H3 - Highly Attractive Pan-Tumor Target
B 7 H 3 - H i g h l y Attractive P a n - T u m o r T a r g e t 22
Slide 23: BetaBart: Deliberately Designed
BETABART: Deliberately Designed Fc MUTATIONS INTRODUCED TO DISRUPT FcRn AND FcγR BINDING TO ACCELERATE BLOOD CLEARANCE AND DECREASE MARROW EXPOSURE BETABART® B L O O D C L E A R A N C E O F B E T A B A R T IN H U M A N S (ESTIMATED) (Allometric Scaling of Blood Clearance of Predecessor Antibody MIL3
Slide 24: BetaBart Preclinical Efficacy
BETABART Preclinical Efficacy 56% S U R V I V A L W I T H S I N G L E I N J E C T I O N A F T E R 100 D A Y S 100 CT26 hB7H3 100uCi90Y-DOTA-MIL33B I.V. (n = 15) CT26 Vector 100uCi90Y-DOTA-MIL33B I.V. (n = 9) 90 CT26 hB7H3 Saline I.V. (n = 23) 80 CT26 hB7H3 nothing (n = 20) 70 Percent Survival 60 50
Slide 25: 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 25
Slide 26: 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 27: 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 ✓ Shortened half life Heart (Blood) Tumor SPECT-CTs @24h WT = wild-type HeLa cells with hu 4Ig expression; KO = B7-H3 gene knockout;
Slide 28: In-Vivo Biodistribution of 177Lu-BetaBart
In-Vivo Biodistribution of 177Lu-BetaBart 177Lu-BetaBart tumor uptake over time Data demonstrating specific tumor targeting in cancer cells expressing human 4Ig with no/minimal effect of excess cold antibody All time points: tumor uptake in HeLa WT xenografts in WT significantly higher than in HeLa
Slide 29: BetaBart Clinical Development
CLINICAL DEVELOPMENT The modifications of the antibody have created an investigational drug with an optimal profile: ➢ High affinity, Selective tumor targeting, Reduced half-life, Very low kidney uptake • Preclinical models validated selective targeting of tumor cells • Significant tumor reduction,
Slide 30: BetaBart Key Milestones
BETABART K E Y M I L E S T O N E S 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 cohorts RV01 Solid Tumors Therapy Lu177 FDA meeting submission (mAb) Data release First Patient Dosed ACHIEVED Future
Slide 31: Targeting MoA: KLK3 - RAD402 Prostate Cancer
T a r g e t i n g MoA: K L K 3 Molecule: R A D 4 0 2 – 161Tb T h e r a p e u t ic for: P R O S T A T E C A N C E R
Slide 32: RAD402 KLK3 Targeting Monoclonal Antibody
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 33: RAD402 - In Vivo Findings
RAD 402 - In Vivo Findings [89Zr]-PET IN CYNOMOLGUS MONKEYS - BIODISTRIBUTION Well-tolerated at 0 . 2 mg/kg with favorable organ biodistribution Specific prostate targeting visualized clearly b y [ 8 9 Zr]hu5A10 PET/CT over the entire observation period 33
Slide 34: RAD402 - In Vivo Findings SPECT Biodistribution (Mice)
RAD 402 - In Vivo Findings SPECT Biodistribution (Mice) SUMMARY ▪ 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) ▪ Ex vivo whole blood PK analysis revealed a terminal h
Slide 35: RAD402 - In Vivo Findings
RAD 402 - In Vivo Findings SPECT Derived In Vivo Biodistribution (Mice) Showing Long Tu Activity concentration at 4h (blue), 2 h (red), 48h (green), 120h 161Tb-RAD400 activity concentration in all ROIs between 4 h and 192 h p.i. (purple), and 192h (grey) p.i. 35
Slide 36: 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. 36
Slide 37: The Evolving Prostate Cancer Therapeutic Landscape
The RADEvolving Prostate 402 – Potential Cancer TherapeuPredicted in Post-Pluvicto Settings - Multiple Opportunities for RAD 402 after Expanded Pluvicto Approvals RAD402 *Pluvicto Docetaxel NHT HSPC conventional imaging (+) HSPC conventional imaging (-) PSMA PET +/- *Pluvicto(?) Chemotherapy Chemoth
Slide 38: Ideal Radiotherapy in Post-Pluvicto Settings
Ideal Radiotherapy in Post-Pluvicto Settings Switch Isotope Switch MoA Ac225 KLK2 Pb212 KLK3 PLUVICTO Relapse or Cu67 EGFR progression 1st line RLT Tb161 other Limitation = 23 Gy absorbed kidney dose (EBRT-derived) Same excretion pathway Switch from renal to hepatic excretion PLUVICTO Peptides mAbs
Slide 39: RAD402 Clinical Development
RAD 402 Clinical Development Preclinical models validate selective targeting of tumor cells Significant tumor reduction and increased survival in the animal models GMP CMC production completed GLP TOX and Biodistribution studies completed Phase I therapeutic trial 2H 2025 in Australia PRECLINICAL PH
Slide 40: RAD402: Key Milestones
RAD 402: KEY MILESTONES TARGET & 2ND HALF 1ST HALF 2ND HALF 1ST HALF PROGRAM INDICATION Dx/Tx ISOTOPE MOLECULE 2024 2025 2025 2026 KLK3 RAD402 PROSTATE Therapy Tb161 BioD & Tox studies CMC completed Ethics First Patient (mAb) completed Committee Dosed Approval ACHIEVED Future Milestone 40
Slide 41: Molecule: 18F-RAD101 Short Chain Fatty Acids
Molecule: 18F-RAD101 T a r g e t i n g MoA: S H O R T C H A I N F A T T Y A C I D S I m a g i n g for: S U S P E C T E D R E C U R R E N T B R A I N M E T A S T A S E S
Slide 42: RAD101 Diagnostic: Imaging for Brain Metastasis
R A D 101 D I A G N O S T I C IMAG ING F O R B R A I N M E T A S T A S I S R A D 101 ( P I V A L A T E ) S M A L L M O L E C U L E Selectively tar gets fatty a c i d synthase: overexpressed in t u m o r s b u t no t n o r m a l brain cells LINKER CANCER CELL TARGET TARGETING RADIOACTIVE F a t t y ac
Slide 43: RAD101 Positive Phase II Data in Brain Metastases
RAD 101 Positive Phase II Data in RESULTS F18-pivalate PET: high uptake independent of primary Brain Metastases Study ▪ High FPIA uptake seen in all IMD (intracranial disease) compared to contralateral white matter, regardless of tumor of origin (p = 0.0001) ▪ Patients with maximum PET SUVmax ≥ 2.0
Slide 44: RAD101 Diagnostic: Clinical Development
RAD 101 DIAGNOSTIC: SMALL MOLECULE TARGETING FATTY ACID SYNTHASE CLINICAL D E V E L O P M E N T Phase IIb imaging study currently recruiting (USA)* No competitor expected 300,000 new patients diagnosed every year (US only) PRECLINICAL PHASE I P H A S E IIa P H A S E IIb P H A S E III UK UK USA 24 pt
Slide 45: RAD101 Diagnostic – 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 Primary Objective: Concordance between RAD101 positive lesions and those seen in conventional imaging (MRI) in participants with suspected recurrent brain me
Slide 46: RAD101: Key Milestones
RAD101: KEY MILESTONES TARGET & 1ST HALF 2ND HALF 1ST HALF 2ND HALF 1ST HALF PROGRAM INDICATION Dx/Tx ISOTOPE MOLECULE 2024 2024 2025 2025 2026 Short IND Approval Early interim BRAIN First Patient RAD101 Chain Imaging F18 Phase 2b N=30 Ph 2b data Phase 2 Fatty Acid METS Read-out (Small Molecule) Las
Slide 47: Targeting MoA: αVβ6 Integrin - Pancreatic Cancer
Molecule: 6 8 G a - R A D 3 0 1 T a r g e t i n g MoA: αVβ6 I N T E G R I N I m a g i n g for: P A N C R E A T I C C A N C E R
Slide 48: RAD301 Diagnostic: Imaging for Pancreatic Cancer
R A D 301 D I A G N O S T I C IMAG ING F O R P A N C R E A T I C C A N C E R R A D 301 (T r i ve hexi n) P E P T I D E R G D p e p t i d e (arginylglycylaspartic acid) Integ r i n αvβ6 receptor a nta g o ni s t D e s i g n features i n c l u d e hydrophilicity to r educe LINKER n o n - specific u p
Slide 49: Patients Imaged with 68Ga-RAD301 to Date
80 PATIENTS IMAGED WITH 68GA-RAD301 TO DATE MULTI-INDICATION POTENTIAL BEYOND PANCREATIC CANCER 44 Pancreatic Ductal Adenocarcinoma (PDAC) patients imaged under 3rd party (Germany) compassionate use.* 32 patients: 12 PDAC, 20 Head & Neck Squamous Cell Carcinoma(HNSCC) imaged in Investigator Initiate
Slide 50: Imaging of Solid Tumors with 68Ga-RAD301
IMAGING OF SOLID TUMORS WITH 68Ga-RAD301 1,2 68Ga-RAD301 PET demonstrates high suitability for specific imaging of αvβ6-integrin expressing cancers and associated metastases. Data demonstrate superior resolution vs 18F-FDG PET. ➢ RAD301 is suitable for imaging of pancreatic cancer due to ➢ RAD301 sh
Slide 51: 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 Patients 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 patients with PDAC • Selective dete
Slide 52: Upcoming Milestones
UPCOMING MILESTONES TARGET & 2ND HALF 1ST HALF 2ND HALF 1ST HALF PROGRAM INDICATION Dx/Tx ISOTOPE MOLECULE 2024 2025 2025 2026 Last patient Integrin dosed RAD301 αVβ6 Multiple Imaging Ga68 Phase I Phase I Phase II (Peptide) ongoing ongoing start Trial read-out ACHIEVED Future Milestone 52
Slide 53: Corporate
Qe RAD RADIOPHARM THERANOSTICS Corporate
Slide 54: Corporate Snapshot
CORPORATE SNAPSHOT S t o c k Code: Investor Syndicates: A S X (Nov 2021): RAD LANTHEUS Ho with 12.1% N A S D A Q ( D e c 2024): RADX U S Biotech F u n d s (3/31/2025) P o i n t 72 Silverarc Market Cap: A U D $ 6 5 m Dellora Shares o n Issue: 2.3 billion Opt i ons o n Issue: 8 5 0 m @ 6 c / 2y No. of
Slide 55: Management Team
M A N A G E M E N T TEAM Dr. Sherin Al-Safadi VP Medical & Corporate Vimal Patel Barbara Lani Riccardo Canevari Dr. Dimitris Voliotis V P CMC V P Quality Affairs Affairs Chief Executive Officer Chief Medical Officer • Radiopharm • Radiopharm Theranostics C E O Theranostics CMO since September since
Slide 56: 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 57: Multiple Near-Term Catalysts with Potential for Value Creation
Revolutionizing Oncology Treatment with Radiopharmaceuticals Multiple near-term catalysts with the potential for value creation Achievements Upcoming Milestones ✓ Initiated Phase I therapeutic study of RAD-204 in multiple solid tumor • Early cohort data from Phase 1 cancers study of RAD-204 in solid
Slide 58: Thank You
Thank You www.radiopharmtheranostics.com
Slide 59: Other Preclinical Programs
m= RAD RADIOPHARM THERANOSTICS OTHER PRECLINICAL PROGRAMS
Slide 60: Targeting MoA: 177Lu-αVβ6 Integrin - RAD302
T a r g e t i n g MoA: 177Lu-αVβ6 I N T E G R I N Molecule: R A D 302 T h e r a p e u t ic for S O L I D T U M O R S
Slide 61: RAD302 - Therapeutic
R A D 302 - T H E R A P E U T I C Lu177-Integrin αVβ6: Pan-solid tumor potential beyond pancreatic cancer I n t e g r i n αvβ6 e x p r e s s i o n i n h u m a n c a n c e r s CLINICAL DEVELOPMENT • GMP peptide production ongoing • Potential Phase I ethics committee submission by 1H 2026 (N. Schmid e
Radiopharm Theranostics — Investor Presentation (August 2025) on 6ix