Investor Presentation - Clinical Update and Capital Raising
Released
Released
Announcement PDF
OCTOBER 20th, 2025
NASDAQ: RADX / ASX: RAD
CLINICAL UPDATE AND CAPITAL RAISING
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Any opinions expressed reflect the Company’s position at the date of this presentation and are subject to change.
2
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 Lu177
Phase 1 enrolling, NCT06824155
DL 1 at 30mCi completed
DL 2 at 75mCi recruiting
RAD204
PD-L1
(nanobody)
PD-L1+ solid tumors Lu177
Phase 1 enrolling, NCT06305962
DL1 at 30mCi completed
DL2 at 60mCi completed
DL3 at xxmCi (DSMC decision in mid
November)
RAD301
Integrin [avB6]
(peptide)
Integrin αvβ6+ Pancreatic
cancer
Ga68 Phase 1 imaging trial enrolling, NCT05799274
6 patients dosed / 9 patients total
Clinical Data Update From Four Clinical Trials (Oct 20th, 2025)
3
Molecule: 18F-RAD101
Targeting MoA: SHORT CHAIN FATTY ACIDS
Imaging for: SUSPECTED RECURRENT BRAIN METASTASES
4
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
18F
FATTY ACID SYNTHASE IS A VIABLE TARGET
✚ Upregulation of de novo fatty acid synthesis via Fatty Acid
Synthase (FASN) enables cancer cells to grow in lipid-deprived
brain microenvironment.
✚ Disruption of FASN activity can impair growth of brain
metastases, representing a viable therapeutic target.
IMAGING
✚ First-in-class Phase 2b imaging study currently recruiting (US).*
✚ High unmet need to detect early relapse after Stereotactic Radio
Surgery in brain metastases from solid tumors of different origin
✚ ~300,000 new subjects diagnosed every year (US only)
RAD 101 DIAGNOSTIC
*NCT06777433
18F, fluorine-18; IIb, phase 2b; PET, positron emission tomography; US, United States. 5
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, stereotactic radiosurgery. 6
• Study Design:
Single dose RAD101, max 370 MBq (10 mCi), administered IV followed by whole brain PET/MRI scan at 60 ± 10 min
post-dose. Four-week screening period, 3-day imaging and safety follow-up, longitudinal imaging and data collection
up to 6 months. Study size: n=30.
RAD 101 DIAGNOSTIC
Eligibility
• Known history of brain metastases
(lung, breast, colon, kidney, melanoma)
• Suspected relapse or progression following
stereotactic radiosurgery (SRS)
10mCi RAD101
Whole Brain PET
(N=30)
Endpoints
• Concordance between
PET and MRI lesions
6 Months
Longitudinal
Follow-up
▪ 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 PHASE I PHASE 2a PHASE 2b PHASE 3
UK UK
24 pts 22 pts 30 pts 150 pts
7
US
UK UK UK
• 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 December; N=30/30 pts by Feb
2026
• Phase 2b readout in the first half of 2026
Executive Summary - new clinical data
RAD 101 DIAGNOSTIC
1S. Islam et. Al., EJNMMI; 07 February 2025; https://doi.org/10.1007/s00259-025-07118-0
MRI, magnetic resonance imaging; SOC, standard of care; SUV, standardized uptake value. 8
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 suspected relapsed brain metastasis
after SRS (see reticle)
PET shows dark spot of metabolic activity in same location,
increasing the possibility of this being a relapse
MRI PET
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 a suspected relapsed brain metastasis after
SRS (see reticle). It is unclear if this is active tumor or
necrosis following SRS (appearance of a cavity)
MRI PET
PET shows high metabolic activity (white ring) surrounding a dark
necrotic area (cavity) which is strongly indicative of a relapsed
brain metastasis surrounding a necrotic area
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 beyond the area in question from MRI
MRI PET PET
11
RAD101 COMMERCIAL POTENTIAL: USD$500m+ yearly sales ( U S A o n l y )
T h i r d l a r g e s t i m a g i n g m o l e c u l e a f t e r P i l a r i f y ( L a n t h e u s ) & I l l u c i x ( T e l i x )
12
RAD101 Estimated Sales
Based on a number of assumptions outlined below, RAD 101 market share is projected to peak at 94.2% in Year 8 of commercialisation,
generating revenue in excess of USD$500m
Note: 1 In the scenario where RAD101 is the sole product on the market, the peak market share of 100% has been adjusted with a 5% discount
factor to account for potential deviations in HCP behavior, such as non-adherence to guidelines or shifts in the SoC. Source: Definitive Healthcare;
Primary research: Alira Health analysis
Key Assumptions
• Target population: Post SRS Treatment PET + MRI
• Competition: None - RAD 101 is the only PET
agent in clinical development for Brain Mets
• Number of post-therapy (SRS) scans: 1.1
• ASP per dose: USD$3,917
Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8
Year 1 to Year 8
Molecule: 177Lu-RAD202
Targeting MoA: HER2
Therapeutic for: HER2+ TUMORS
13
RAD 202 Utilizes Anti-PD-L1 Nanobody as Targeting Moiety
CANCER CELL
TARGET
HER2
TARGETING
MOLECULE
Sd mAb
LINKER
RADIOACTIVE
ISOTOPE
177Lu
HER2+ THERAPY FOR subjects REFRACTORY TO TRASTUZUMAB DERUXTECAN (Enhertu®)
Post-Enhertu® Market Increasingly Attractive
✚ Enhertu® moving up treatment lines (DESTINY-BREAST trials)
✚ Eligible patient numbers increasing (HER2-low/very low identification and approval)
✚ No established therapy following Enhertu® (total addressable market ~ USD 8-9 $B)
HER2 NANOBODY
High specificity & affinity single-domain antibody
• HER2 pathway well validated
• Overexpression in breast, and
gastroesophageal cancers
• Improved tumor penetration, accumulation and
rapid blood clearance (small size)
RAD 202 THERAPEUTIC
HER2, human epidermal growth factor receptor 2; kDa, kilodalton; mAb, monoclonal antibody; nm, nanometer; Sd, single domain; USD, United States dollar. 14
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. 15
RAD 202 THERAPEUTIC
Dose Level Dose
Phase 0
(Imaging Period with
177Lu- RAD202im)
Imaging dose 10 mCi
Phase I
(Treatment Period
with 177Lu- RAD202tr)
Therapeutic DL1 30 mCi (1.1 GBq)
DL2 75 mCi (2.7 GBq)
DL3+ TBD
PROGRAM TARGET & MOLECULE INDICATION Dx/Tx ISOTOPE 1ST HALF 2024 2ND HALF 2024 1ST HALF 2025 2ND HALF 2025 1ST HALF 2026 2ND HALF 2026
RAD 202
HER2
(Nanobody)
HER2+
Solid Tumors Therapy Lu177
Preclinical Studies
Completed
Ethics Approval
(Dec 2024)
First Patient
dosed
2 Cohorts
Completed
2 Cohorts
Data Release
Phase 1
Last Patient Dosed
• There are currently n=3 subjects in treatment in cohort #1 (30 mCi) with data available
• DSMC on Sept 30th, 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 favorable, with few low-grade adverse events and no
SAEs observed thus far
Executive Summary | Current Study Status
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. 16
RAD 202 THERAPEUTIC
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 PVC1,2
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
1Partial Volume Correction applied.
2Density of lesion: soft tissue = 1.0 g/mL. Bone = 1.3 g/mL
3Lesions were contours based on thresholding (40%) method and volume was averaged over all timepoints
*BR = background – shoulder and proximal thigh. T:BR = lesion SUVmax:BR SUVmean
GBq, gigabecquerel; Gy, gray; ml, milliliter; PVC, partial volume correction; ROI, region of interest; SUV, standardized uptake value;
SUVmax, maximum standardized uptake value; SUVmean, mean standardized uptake value; TBR, target-to-background ratio.
17
RAD 202 THERAPEUTIC
NM1 – SEC 2
5TP Baseline PET
D0 ACSCRR [BQML 9.85]
NM2a – SEC 3
5TP 2nd follow up PET
C1D2 ACSCRR [BQML 9.85]
NM4 – SEC 5
Current PET
C1D8 ACSCRR [BQML 9.85]
SUV
6
5
4
3
2
1
0
7
Absorbed
Dose
at 30 mCi
Cycle Lesion Volume (ml)
Dose (Gy),
with PVC1,2
C1 ROI-3 5.821 2.732
C1 ROI-6 23.02025 1.581
C1 ROI-7 43.224 1.831
C1 ROI-8 145.1585 1.286
C1 ROI-9 16.796 2.084
C1 ROI-10 20.9355 2.092
C1 ROI-11 20.31075 2.959
C1 ROI-12 20.31075 1.558
C1 ROI-13 30.34125 0.854
PATIENT #2
Absorbed
Dose
at 30 mCi
Cycle
Lesion
(refer to Viedoc
for lesion’s
location
for each ROI)
Volume
(ml)
Dose (Gy),
with PVC1,2
C1 ROI-2
48.7975
0.848
C1 ROI-3
60.502
0.661
C1 ROI-4
25.8
0.793
C1 ROI-6
26.85
0.964
C1 ROI-11
17.256
1.235
PATIENT #3
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 reported in Dose Level 1
Adverse Events Summary (interim data) | Dose Level 1
Molecule: 177Lu-RAD204
Targeting MoA: PD-L1
Therapeutic for: PD-L1+ TUMORS
19
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
177Lu
BENEFITS OF NANOBODIES
✚ Specificity and affinity of a full-size antibody; binds to
different epitopes than approved full-sized antibodies
✚ Improved tumor penetration and accumulation (small size)
✚ Rapid blood clearance
Anti-PD-L1 Nanobody
High affinity single domain monoclonal antibody
PD-L1 Immune Checkpoint
• Antigen expression mediates evasion of
immune responses by cancer cells
• Inhibition leads to antitumor activity
THERAPEUTIC APPLICATION
✚ First-in-class PD-L1 radiotherapeutic in development
✚ High unmet need in subjects refractory to Checkpoint Inhibitors
✚ Very large total addressable market in 2nd line metastatic, post
Checkpoint Inhibitors+ chemotherapy
20
Dose Level Dose
Phase 0
(Imaging Period with
177Lu-RAD204im)
Imaging dose 10 (0.37 GBq)
Phase I
(Treatment Period
with 177Lu-RAD204tr)
Therapeutic DL1 30 mCi (1.1. GBq)
DL2 60 mCi (2.2 GBq)
DL3+ TBD
Phase 1 Trial Design
177Lu-anti-PD-L1 single domain AB in metastatic solid tumors
21
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.
PROGRAM TARGET & MOLECULE INDICATION Dx/Tx ISOTOPE 1ST HALF 2024 2ND HALF 2024 1ST HALF 2025 2ND HALF 2025 1ST HALF 2026
RAD 204
NCT06305962
PD-L1
(Nanobody)
PD-L1+
Solid Tumors
Therapy Lu177
Ethics Approval
Received
• First Patient Treated
• Approval for Trial Expansion
in 6 Tumor Types
1 Cohort
Completed
2 Cohorts Completed
Phase 1
dose escalation
completed
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 are available from n=3 subjects in cohort #1 (30mCi) and n=3* subjects from cohort #2 (60mCi)
• DSMC meeting planned for mid of November to certify Cohort #2 completion and to approve start of Cohort #3
• The clinical activity is under evaluation. Thus far, 2/3 subjects (67%) at the lowest (30mCi) dose level have
shown disease stabilization and treatment duration of 5+ months, which exceeds the typical PFS of
approximately 3.5 months reported in such a last line patient population of NSCLC
• The safety profile has been very favorable, with few adverse events and no related SAEs observed thus far
RAD 204 THERAPEUTIC
22
RAD 204 THERAPEUTIC
Absorbed dose
at 30 mCi
Cycle Lesion
Volume
(ml)2 D1 SUVmax SUV T:BR*
Dose (Gy),
with PVC1,2
C1
Primary (left
lung apex)
111.87583
2.8 4.36 0.18
C1
Primary -
core 11.48 0.46
C1 RLL met 32.35063
2.95 4.57 0.23
C1 RLL met - CT 5.974 0.59
C1 RML met 25.61963
4.2 6.09 0.52
C1
RML met –
core
11.44 0.78
1Partial Volume Correction applied.
2Density of lesion: soft tissue = 1.0 g/mL. Bone = 1.3 g/mL
3Lesions were contours based on thresholding (40%) method and volume was averaged over all timepoints
4CT-based contouring is smaller than 11.5 mL. So the “core” contouring was not performed.
*BR = background – shoulder and proximal thigh. T:BR = lesion SUVmax:BR SUVmean 23
SUV
6
5
4
3
2
1
0
7
C1
RML
C1
RLL
Location of sampling PD-L1 expression IHC (%)
Right lung 10
Lesion Dosimetry | 003-001 (NSCLC)
Selective uptake of 177Lu-RAD204 in primary and metastatic pulmonary lesions
Lesion Dosimetry | 003-002 (sqNSCLC)
Selective uptake of 177Lu-RAD204 in pulmonary lesions
RAD 204 THERAPEUTIC
Absorbed dose
at 30 mCi
Cycle Lesion
Volume
(ml)2 D1 SUVmax SUV T:BR*
Dose (Gy),
with PVC1
C1
Primary (Left
lung perihilar)
151.42864
4.54 6.16 0.16
C1 Primary – core 11.47 0.74
C23
Primary 201.224 0.15
C23 Primary - core 11.288 0.77
1Partial Volume Correction applied
2Density of lesion: soft tissue = 1.0 g/mL. Bone = 1.3 g/mL
3C2 dosimetry is based on STD approach.
4Lesions were contours based on thresholding (40%) method and volume was averaged over all timepoints.
*BR = background – shoulder and proximal thigh. T:BR = lesion SUVmax:BR SUVmean 24
SUV
6
5
4
3
2
1
0
7
C2D1
C1D1
C3
C1D2
C4
C1D3
Location of sampling PD-L1 expression IHC (%)
Left lung 95
Lesion Dosimetry | 003-006 (NSCLC)
Selective uptake of 177Lu-RAD204 in primary and metastatic pulmonary lesions
RAD 204 THERAPEUTIC
Absorbed dose
at 30 mCi
Cycle Lesion
Volume
(ml)2 D1 SUVmax SUV T:BR*
Dose (Gy),
with PVC1
Im Primary (RUL) 47.3216 2.7 3.4 0.18
Im T2 43.797 3.5 4.4 0.15
C1 Primary (RUL) 103.7125 1.7 3.0 0.14
C1 T2 49.9054 2.78 4.78 0.21
C1 L Liver 71.7364 5 8.6 0.42
C2* Primary (RUL) 97.159 0.11
C2* T2 81.58 0.13
C2* L Liver 82.346 0.24
1Partial Volume Correction applied
2Lesions were contours based on thresholding (40%) method and volume was averaged over all timepoints.
3Density of lesion: soft tissue = 1.0 g/mL. Bone = 1.3 g/mL
*BR = background – shoulder and proximal thigh. T:BR = lesion SUVmax:BR SUVmean 25
IMD2
IMD2
SUV
6
5
4
3
2
1
0
7
ImD – T2
ImD – Primary (RUL)
IMD3
IMD3
IMD4
IMD4
Location of sampling PD-L1 expression IHC (%)
Right lung 30
x
Cohort 1 - 30mCi Dose Level
Preliminary Clinical Activity (PFS of 5+ months) in 2/3 subjects (67%) exceeds historical controls
26
RAD 204 THERAPEUTIC
1subjects without actionable mutations. Soon YY, et al. Clinical Trial and Real-World Outcomes of subjects With Metastatic NSCLC in the Post-Platinum-Based
Chemotherapy Failure Setting. JTO Clin Res Rep. 2023;4(11):100579. Published 2023 Sep 28. doi:10.1016/j.jtocrr.2023.100579.
0 1 2 3 4 5 6
Participant
Dose
RAD204 – Swimmer Lane Plot
003-006_(DL1/30mCi/1.1GBq)
003-002_(DL1/30mCi/1.1GBq)
003-001_(DL1/30mCi/1.1GBq)
NSCLC Last Line Historical Progression Free Survival
≅ 3.5 months1
Event Type
Stable disease (SD)
Disease Progression
177Lu-RAD204 Dose administered
Months from Cycle 1
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
SUVmax
SUV
T:BR*
Dose (Gy),
with PVC1,2
C1 Primary 113 2.1 5.1 0.33
C1
Lymph node
axillary left
(ROI-3)
27 2.7 6.6 0.61
C1
Lymph node
supraclavicular left
(ROI-4)
27 3 7.3 0.7
C1
Lymph node
supraclavicular right
(Level V) (ROI-6)
37 1.8 4.3 0.35
C1
Liver Segment VI
(ROI-9)
47 6.3 15.4 3.0
# Patient 003-009 is not DLT-evaluable (consent withdrawal due to personal reasons)
1Partial Volume Correction applied.
2Density of lesion: soft tissue = 1.0 g/mL. Bone = 1.3 g/mL
3Lesions were contours based on thresholding (40%) method and volume was averaged over all timepoints
*BR = background – shoulder and proximal thigh. T:BR = lesion SUVmax:BR SUVmean
27
Absorbed
dose
at 60 mCi
Cycl
e
Lesion
Volume
(ml)2
D1
SUVmax
SUV
T:BR*
Dose (Gy),
with PVC1,2
C1 ROI-4 8.3 2.5 4.7 0.5
Absorbed dose
at 60 mCi
Cycle Lesion
Volume
(ml)2
D1
SUVmax
SUV
T:BR*
Dose (Gy)
IM with
PVC1,2
Dose (Gy)
C1 with
PVC1,2
IM
ROI-7
(Spleen)
16.28 15.2 20.7 1.0 2.8
PATIENT #5
PATIENT #6
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 physician, despite it being pre-existing at
study entry: increased lipase (isolated, asymptomatic)
Serious Adverse Events
• There were n=2 SAEs in Dose Levels 1 and 2. None were related to study drug
• N=2 subjects experienced SAEs (resulting in hospitalization) which were due to 1) subject with worsening of
previous underlying non-cancerous condition (lung infection) and 2) n=1 subject with worsening of underlying
cancerous condition (progression of disease)
• Neither of these two subjects received a therapeutic dose of the study drug. One subject only underwent screening,
the other subject only received one imaging dose of 10mCi
Adverse Events Summary (interim data) | Dose Levels 1 and 2
RAD 204 THERAPEUTIC
Molecule: 68Ga-RAD301
Targeting MoA: αVβ6 INTEGRIN
Imaging for: PANCREATIC CANCER
29
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 selectivity,
uptake and tumor retention
Imaging for Pancreatic Cancer
68Ga, gallium-68; αvβ6, alpha-v beta-6; ADC, antibody drug conjugate; IIa, phase 2a; n, number of subjects; NSCLC, non-small cell lung cancer; RGD,
arginylglycylaspartic acid; TGFβ, transforming growth factor beta; Tx, treatment. 30
CANCER CELL
TARGET
integrin αvβ6
TARGETING
MOLECULE
trivehexin
LINKER
RADIOACTIVE
ISOTOPE
68Ga
INTEGRIN αvβ6
✚ Upregulated target often referred to as “cancer integrin” given
its role in activation of TGFβ; expression correlates with
decreased survival in numerous carcinomas.
✚ Pfizer αvβ6 integrin ADC Phase III in NSCLC.
αvβ6 INTEGRIN EXPRESSING TUMORS
✚ Pancreatic cancer is first targeted indication (~60% expression).
✚ Approx. n=80 subjects already dosed in IIS and under German
compassionate use program.
✚ Strong peer reviewed presence in several journals and
congresses.
RAD 301 DIAGNOSTIC
• 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 (NSCLC), Triple Negative
Breast Cancer (TNBC), Ovarian, Thyroid Cancer
• Ongoing Phase 1 imaging study in Pancreatic Cancer
ongoing at Montefiore, NY and United Theranostic, NJ***
• Phase 1 is used to confirm Proof-Of Concept in subjects with
metastatic pancreatic cancer
• Phase 2 in preparation in subjects with loco-regional disease
(pre-metastatic)
80 Subjects Imaged With 68GA-RAD301 To Date
Multi-indication Potential Beyond Pancreatic Cancer
3rd PARTY
COMPASSIONATE
USE (Germany)*
IIR IN PDAC &
HNSCC** +
4 Single Case
Publications
PHASE 1 (USA)*** Phase 2 (USA)
44 pts
32 pts + 4 pts = 36
pts
9 pts 30 pts
Ongoing In Preparation
*Rehm J, et al. Front. Nucl. Med. 4:1487602. doi: 10.3389/fnume.2024.1487602, **Das, S. et al,. Clin Nucl Med 49, 733–740.
doi.org/10.1097/RLU.0000000000005278
*** NCT05799274.
HNSCC, head and neck squamous cell carcinoma; IIR, investigator-initiated research; NSCLC, non-small cell lung cancer;
PDAC, pancreatic ductal adenocarcinoma; TNBC, triple negative breast cancer. 31
RAD 301 DIAGNOSTIC
UPCOMING MILESTONES
PROGRAM
2NDHALF
2024
1ST HALF
2025
2NDHALF
2025
RAD301
Phase I
Phase 1
ongoing
Phase 1
ongoing
Last
patient
dosed
ACHIEVED
PROGRAM
1ST HALF
2026
2NDHALF
2026
1ST HALF
2027
2ND HALF
2027
RAD301
Phase 2
CLINICAL SITES
EXPANSION
TRIAL
START
ENROLLING TRIAL
COMPLETED
TRIAL POPULATION
Metastatic Pancreatic Cancer
- Adequate for proof of concept
- subjects with more extensive disease, more frail,
difficult to recruit
- Limited patient benefit
TRIAL POPULATION
Loco-Regional Pancreatic Cancer
High risk of metastatic disease
- Higher unmet need
- Higher patient benefit
- Healthier patient population
- Easier to recruit
- More willing to participate in trials
- Larger prevalence
32
Executive Summary
33
RAD 301 DIAGNOSTIC
αVβ6, alpha-v beta-6 integrin; cm, centimeter; GYN, gynecologic; n, number of subjects; RAD301, radiolabeled αVβ6-targeted diagnostic agent.
• 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 for
detection and monitoring of primary tumors and metastatic lesions as small as <1cm
• 6 subjects dosed as 10/20/2025; expected 9/9 subjects by Dec 2025
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. 34
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. 35
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. 36
Appendix
www.radiopharmtheranostics.com
37
RAD is at the Cutting Edge of Radiopharmaceuticals, a Transformative Modality Within Cancer
TREATMENT
Radiopharmaceuticals Expertise, In licensing Strategy & Intellectual Property
• All team members with previous imaging and therapeutic radiopharmaceutical experience
• Scientific Advisory Board of accredited multinational researchers
• Extensive patent portfolio for targets through 2040
Differentiated Within Radiopharmaceuticals
• Clinical-stage company with deep pipeline of radiotherapeutic assets pursuing novel targets
– Targets include PD-L1, HER2 (nanobody platform); integrin αVβ6 (peptide) fatty acid synthase (small molecule)
– Six trials anticipated to be in clinical stage by December 2025; 2 Diagnostics (Brain Mets; Pancreas) and 4 Therapeutics (PD-L1; HER2; B7H3, KLK3)
– Radiopharm Ventures, a Joint Venture with MD Anderson Cancer Center - in-licensed from MDACC technologies for radiopharmaceuticals use. First technology has been disclosed (B7H3-
targeting molecule)
Fully funded to achieve multiple near-term catalysts with the potential for value creation
• Q4 2025 (ongoing): Interim data released for Phase 2b imaging study of RAD-101 (Brain Mets) – Positive data from first 3 patients now available (see pages 9 – 11)
• Q4 2025 (ongoing): Interim data released from Phase 1 study with RAD301 (AvB6) – Positive data from first 3 patients now available (see pages 33 – 35)
• Q4 2025 (ongoing): Early cohort data from Phas
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