Presentation to Annual General Meeting
Released
Released
Announcement PDF
NOVEMBER 20 , 2025
NASDAQ: RADX / ASX: RAD
Annual General Meeting
Notice & Disclaimer
2
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 (Company). In preparing this presentation, the Company did not take into account the investment objectives, financial situation
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Whilst this presentation is based on information from sources which are considered reliable, no representation or warranty, express or implied, is made or given by or on behalf of the Company, any of its
directors, or any other person about the accuracy, completeness or fairness of the information or opinions contained in this presentation. No responsibility or liability is accepted by any of them for that
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trials will be delayed and not completed on a timely basis; the risk that the results from the clinical trials are not as favourable as we anticipate; the risk that our clinical trials will be more costly than anticipated;
and the risk that applicable regulatory authorities may ask for additional data, information or studies to be completed or provided prior to their approval of our products. Given these uncertainties, undue reliance
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the US Securities Act and applicable US state securities laws.
Any opinions expressed reflect the Company’s position at the date of this presentation and are subject to change.
Investments Highlights
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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
• Co-development agreement with and Joint Venture with MD Anderson
Experienced management team
Financials
• Cash runway to Q1 2027
November updates in yellow
PHASE IIB
PHASE IIA
PHASE I
PRECLINICAL
ISOTOPE
INDICATION
TARGET & MOLECULE
PROGRAM
Phase 2b in 5 US centers, NCT06777433
15 patients dosed / 30 patients total (11/’25)
Expect to complete enrollment 1Q26
F18
Brain Mets
Short Chain Fatty Acid
(small molecule)
RAD101
IMAGING
TRIAL
Phase 1 in 4 AUS centers, NCT06305962
DL1 at 30mCi & DL2 at 60mCi completed
DL3 at 90mCi recruiting
Expect trial completion in 2026
Lu177
PD-L1+ solid tumors
PD-L1
(nanobody)
RAD204
THERAPEUTIC
TRIALS
Phase 1 in 5 AUS centers NCT06824155
DL 1 at 30mCi completed
DL 2 at 75mCi recruiting
Expect trial completion in 2026
Lu177
HER2+ solid tumors
HER2
(nanobody)
RAD202
IND approval 07/2025 NCT07189871
Phase I in 4 US centers, FPFV expected
Q4 2025
First two Dose Levels data in mid-2026
Lu177
B7-H3+ solid tumors
B7-H3
(mAb)
RV01
Ethics approval received (11/2025)
Phase 1 study in 4 AUS centers
First two Dose Levels data in mid-2026
Tb161
Advanced prostate cancer
KLK3
(mAb)
RAD402
Company Priorities – Five first-in-class radiopharmaceutical molecules
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B7-H3, B7 homolog 3; F18, fluorine-18; HER2, human epidermal growth factor receptor 2; KLK3, kallikrein-
related peptidase 3; Lu177, lutetium-177; mAb, monoclonal antibody; PD-L1, programmed death ligand-1;
Tb161, terbium-161.
RAD 101 Imaging: Clinical Development
RAD 101 DIAGNOSTIC
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Phase IIb imaging study currently recruiting in five centers in USA: 50% enrolment 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 diagnosed every year (US only)
USA
PHASE III
PHASE IIb
PHASE IIa
PHASE I
PRECLINICAL
UK
UK
150 pts
30 pts
22 pts
24 pts
* NCT06777433
• Images from n=3 subjects in the ongoing study released
• Showing increased metabolic activity in areas with equivocal MRI findings (suspected relapse)
• N=15 subjects dosed as of 11/17/2025
Clinical Data from Phase IIb
RAD 101 DIAGNOSTIC
6
Phase IIb
• 11 patient data to be released by Q1 2026
• Trial completion N=30/30 pts by Q1 2026
• Phase 2b readout in the first half of 2026
Phase III
• FDA Meeting to align on Phase III - mid 2026
• Phase III start – Q4 2026
Next Steps
RAD 101 DIAGNOSTIC
7
RAD101 COMMERCIAL POTENTIAL: USD$ >500m yearly sales (USA only)
Third largest imaging molecule after Pilarify (Lantheus) & Illucix (Telix)
RAD 101 DIAGNOSTIC
8
Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8
RAD 204 THERAPEUTIC
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Molecule: 177Lu-RAD204
Targeting MoA: PD-L1
Therapeutic for: PD-L1+ TUMORS
Dose
Dose Level
10 (0.37 GBq)
Imaging dose
Phase 0
(Imaging Period with
177Lu-RAD204im)
30 mCi (1.1. GBq)
Therapeutic DL1
Phase I
(Treatment Period
with 177Lu-RAD204tr)
60 mCi (2.2 GBq)
DL2
90 mCi (3.3 GBq)
DL3
DL4
Phase 1 Trial Design
177Lu-anti-PD-L1 single domain AB in metastatic solid tumors
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Primary Objectives
o Safety and tolerability of 177Lu-RAD204
o Recommended ph2 dose of 177Lu-RAD204tr
Study Design
BOIN for escalation / de-escalation.
Population: History of PD-L1 positive (>1%) metastatic tumors
Imaging Phase 0
Biodistribution, dosimetry and PK with low dose
177Lu-RAD204im in organs of interest and tumor
Therapeutic Phase 1
177Lu-RAD204tr dose escalation
RAD 204 THERAPEUTIC
BOIN, Bayesian optimal interval; DL, dose level; GBq, gigabecquerel; mCi, millicurie; PD-L1, programmed death ligand-1; PK, pharmacokinetics; TBD, to be determined.
MID 2026
2ND HALF 2025
1ST HALF 2025
2ND HALF 2024
1ST HALF 2024
ISOTOPE
Dx/Tx
INDICATION
TARGET & MOLECULE
PROGRAM
Phase 1
dose escalation
completed
2 Cohorts Completed
first 6 pts data
released
1 Cohort
Completed
• First Patient Treated
• Approval for Trial Expansion
in 6 Tumor Types
Ethics Approval
Received
Lu177
Therapy
PD-L1+
Solid Tumors
PD-L1
(Nanobody)
RAD 204
NCT06305962
Clinical data Phase I
*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.
• 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 adverse events and no related SAEs observed.
• Currently recruiting Third Cohort (90mCi).
RAD 204 THERAPEUTIC
11
Tumor Uptake| Significant increase at DL2 vs DL1
RAD 204 THERAPEUTIC
12
Average
Absorbed dose
at 60 mCi
Dose (Gy),
with PVC1
Patients
1.0
#4
0.5
#5
2.8
#6
1.43
Average
Absorbed dose
at 30 mCi
Dose (Gy),
with PVC1
Patients
0.56
#1
0.45
#2
0.21
#3
0.41
30
60
90
0.4
1.4
0
0.5
1
1.5
2
2.5
3
3.5
4
0
20
40
60
80
100
120
140
160
180
Cohort #1 Cohort #2 Cohort #3
Tumor
Gy
Lu177
mCi
Column1 Column2
Lu177 mCi Avg Tumor Gy
COHORT#1 COHORT#2
RAD 202 THERAPEUTIC
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Molecule: 177Lu-RAD202
Targeting MoA: HER2
Therapeutic for: HER2+ TUMORS
Primary Objectives (Phase 1, Treatment):
o Safety and tolerability of 177Lu-RAD202
o Recommended ph2 dose of 177Lu-RAD202
Population:
Her2+ (IHC, ISH) a/m solid tumors
Phase 0 Imaging:
Biodistribution, PK and radiation dosimetry of
177Lu-RAD202im in organs of interest and tumor lesions
Phase I Therapeutic:
177Lu-RAD202tr dose escalation
Phase 1 Trial Design
‘HEAT’ Trial (HER2 Antibody Therapy with Lutetium-177) in subjects with HER2+ advanced solid
tumors
a/m, advanced or metastatic; DL, dose level; GBq, gigabecquerel; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry;
ISH, in situ hybridization; Lu177, lutetium-177; mCi, millicurie; PK, pharmacokinetics; TBD, to be determined. 14
RAD 202 THERAPEUTIC
Dose
Dose Level
10 mCi
Imaging dose
Phase 0
(Imaging Period with
177Lu- RAD202im)
30 mCi (1.1 GBq)
Therapeutic DL1
Phase I
(Treatment Period
with 177Lu- RAD202tr)
75 mCi (2.7 GBq)
DL2
TBD
DL3+
2ND HALF 2026
1ST HALF 2026
2ND HALF 2025
1ST HALF 2025
2ND HALF 2024
1ST HALF 2024
ISOTOPE
Dx/Tx
INDICATION
TARGET & MOLECULE
PROGRAM
Phase 1
Dose escalation
completed
2 Cohorts
Data Release
2 Cohorts
Completed
First Patient
dosed
Ethics Approval
(Dec 2024)
Preclinical Studies
Completed
Lu177
Therapy
HER2+
Solid Tumors
HER2
(Nanobody)
RAD 202
• 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
Clinical Data Phase I
1Zhao et al, Br Canc Res (2024); Zhao et al, Mol Pharmaceut (2021)
99mTc, technetium-99m; 177Lu, lutetium-177; mCi, millicurie; NSCLC, non-small cell lung cancer; PD-1, programmed death-1;
PD-L1, programmed death ligand-1; PFS, progression-free survival. 15
RAD 202 THERAPEUTIC
RAD 202 utilizes an anti-HER2 Nanobody as a targeting moiety
RV 01 THERAPEUTIC
16
Molecule: RV01/BetaBart
Targeting MoA: B7H3
Therapeutic for: Multiple Tumor Types
RV01 THERAPEUTIC
17
RV01 (Betabart) Key Milestones
1. Phase I therapeutic trial IND received in July 2025
2. Basket Phase I therapeutic trial to start by the end of 2025
1ST HALF
2026
2ND HALF
2025
1ST HALF
2025
2ND HALF
2024
ISOTOPE
Dx/Tx
INDICATION
TARGET &
MOLECULE
PROGRAM
First two cohorts
Data release
IND
approval
First Patient
Dosed
IND
submission
PRE-IND
FDA meeting
Lu177
Therapy
Solid Tumors
B7-H3
(mAb)
RV01
ACHIEVED
Future Milestone
RAD 202 utilizes an anti-HER2 Nanobody as a targeting moiety
RAD402 THERAPEUTIC
18
Molecule: RAD 402 – 161Tb
Targeting MoA: KLK3
Therapeutic for: PROSTATE CANCER
RAD 402 – mAb targeting KLK3 in Prostate Cancer
RAD402 THERAPEUTIC
19
1. RAD 402 is a humanized IgG1
internalized by prostate cells,
specifically binding KLK3 with high
affinity
2. RAD 402 has highly specific
expression in the prostate
(compared to PSMA, which is
expressed in multiple other organs)
KLK3 is expressed only in prostate. PSMA has more off-target affinity
KLK3
PSMA
RAD 402 – Key Milestones
RAD402 THERAPEUTIC
20
2ND HALF
2025
1ST HALF
2025
2ND HALF
2024
ISOTOPE
Dx/Tx
INDICATION
TARGET &
MOLECULE
PROGRAM
Ethics
Committee
Approval
Phase I start
CMC completed
BioD & Tox studies
completed
Tb161
Therapy
PROSTATE
KLK3
(mAb)
RAD402
ACHIEVED
Future Milestone
1. Ethics Committee approval in Q4 2025
2. Phase I therapeutic trial in Australia to start in Q4 2025
November updates in yellow
PHASE IIB
PHASE IIA
PHASE I
PRECLINICAL
ISOTOPE
INDICATION
TARGET & MOLECULE
PROGRAM
Phase 2b in 5 US centers, NCT06777433
15 patients dosed / 30 patients total (11/’25)
Expect to complete enrollment 1Q26
F18
Brain Mets
Short Chain Fatty Acid
(small molecule)
RAD101
IMAGING
TRIAL
Phase 1 in 4 AUS centers, NCT06305962
DL1 at 30mCi & DL2 at 60mCi completed
DL3 at 90mCi recruiting
Expect trial completion in 2026
Lu177
PD-L1+ solid tumors
PD-L1
(nanobody)
RAD204
THERAPEUTIC
TRIALS
Phase 1 in 5 AUS centers NCT06824155
DL 1 at 30mCi completed
DL 2 at 75mCi recruiting
Expect trial completion in 2026
Lu177
HER2+ solid tumors
HER2
(nanobody)
RAD202
IND approval 07/2025 NCT07189871
Phase I in 4 US centers, FPFV expected
Q4 2025
First two Dose Levels data in mid-2026
Lu177
B7-H3+ solid tumors
B7-H3
(mAb)
RV01
Ethics approval received (11/2025)
Phase 1 study in 4 AUS centers
First two Dose Levels data in mid-2026
Tb161
Advanced prostate cancer
KLK3
(mAb)
RAD402
Company Priorities – Five first-in-class radiopharmaceutical molecules
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B7-H3, B7 homolog 3; F18, fluorine-18; HER2, human epidermal growth factor receptor 2; KLK3, kallikrein-
related peptidase 3; Lu177, lutetium-177; mAb, monoclonal antibody; PD-L1, programmed death ligand-1;
Tb161, terbium-161.
Thank You
www.radiopharmtheranostics.com
22
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