DEP HER2 Investor Webinar
Released
Released
Announcement PDF
ASX Announcement
DEP® HER2 Investor Webinar
Melbourne, Australia; 7 July 2026: Starpharma (ASX: SPL, US OTC: SPHRY), an innovative
biotechnology company with experience in advancing dendrimer technology from the lab to the
patient, today held an investor webinar focusing on the DEP® HER2 preclinical data package and
the company’s plan for clinical development.
The slides for the webinar are appended with this announcement. A recording of the webinar will
be made available on Starpharma’s website.
About Starpharma
Starpharma ASX: SPL, US OTC: SPHRY) is an innovative biotechnology company with two decades of experience in advancing
dendrimer technology from the lab to the patient. Our mission is to help patients with significant illnesses, such as cancer, achieve
improved health outcomes and quality of life through the application of our unique dendrimer technology.
Dendrimers are precise, synthetically manufactured, nanoscale molecules. Their unique properties—including their size, structure,
high degree of branching, polyvalency, and water solubility—are advantageous in medical and pharmaceutical applications.
Starpharma’s portfolio of dendrimer-based products includes three clinical-stage DEP® (dendrimer enhanced product) assets,
preclinical radiopharmaceutical assets, research collaborations, and three commercially marketed over-the-counter (OTC) products.
For more information about Starpharma, visit www.starpharma.com or connect with Starpharma on LinkedIn.
Investor & Media Relations
Gabriella Hold
gaby@thecapitalnetwork.com.au
Starpharma Holdings Limited
Cheryl Maley, Chief Executive Officer
Justin Cahill, CFO and Company Secretary
+61 3 8532 2704
investor.relations@starpharma.com
4-6 Southampton Crescent
Abbotsford Vic 3067
Disclosure
This ASX Announcement was
authorised for release by the Chair,
Mr Rob Thomas.
Forward-Looking Statements
This document contains certain forward-looking statements, relating to Starpharma’s business, which can be identified by the use of forward-looking
terminology such as “promising”, “plans”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”, “targeting”, “aiming”, “set to”,
“potential”, “seeking to”, “goal”, “could provide”, “intends”, “is being developed”, “could be”, “on track”, or similar expressions, or by express or implied
discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forward-looking statements involve
known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance
or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA’s
and other authorities’ requirements regarding any one or more product candidates, nor can there be any assurance that such product candidates will be
approved by any authorities for sale in any market or that they will reach any particular level of sales. In particular, management’s expectations regarding
the approval and commercialization of the product candidates could be affected by, among other things, unexpected trial results, including additional
analysis of existing data, and new data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain
patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and
additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects.
Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from
those described herein as anticipated, believed, estimated, or expected. Starpharma is providing this information as of the date of this document and
does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or
developments or otherwise. Clinical case studies and other clinical information given in this document are given for illustrative purposes only and are not
necessarily a guide to product performance and no representation or warranty is made by any person as to the likelihood of achievement or
reasonableness of future results. Nothing contained in this document, nor any information made available to you is, or shall be relied upon as, a promise,
representation, warranty or guarantee as to the past, present or the future performance of any Starpharma product.
I N V E S T O R P R E S E N T A T I O N M A Y 2 0 2 6
DEP® HER2 preclinical
data, clinical pathway and
why this opportunity
matters
I N V E S T O R W E B I N A R
July 2026
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This presentation contains forward-looking statements that involve risks and uncertainties.
Although we believe that the expectations reflected in the forward-looking statements are
reasonable at this time, Starpharma can give no assurance that these expectations will prove
to be correct. Actual results could differ materially from those anticipated. Reasons may
include risks associated with drug development and manufacture, risks inherent in the
regulatory processes, delays in clinical trials, risks associated with patent protection, future
capital needs or other general risks or factors.
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Disclaimer and forward-looking statements
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DEP® stands for Dendrimer Enhanced Product
Investment Highlights
Global leader in dendrimer technology
Clinically Validated
DEP® Technology
Platform
Novel Radio-
pharmaceutical
Asset
• DEP® HER2 in 3L
HER2+ Gastric
Cancer - FIH / Ph
1 clinical study
2H CY26
• No approved 3L
therapies
• Up to ~US$2.5bn
market
opportunity in
HER2+ gastric
cancer
Three Strategic,
High-value,
Partnerships
Positioned for
Next Generation
Therapies
Portfolio of Partner-
ready Assets
• Over 20 years of
dendrimer
technology
capabilities
• Strategically
managed and
actively
maintained
patent portfolio
• More than 350
patients treated
with DEP® across
multiple clinical
programs
• Two commercial
consumer health
products across
35+ markets
Strong IP &
Uniquely
Experienced Team
• Partnerships with
Genentech,
Medicxi, and
Radiopharm
Theranostics
• Diversified source of
upside with
significant potential
• DEP® Platform
uniquely
positioned to
enhance efficacy
and safety profile
of emerging, high
value modalities,
focusing on
targeted oncology
therapies
• Phase 2 assets:
DEP® SN38 and
DEP® Cabazitaxel
• Demonstrated
efficacy and safety
profile relative to
SoC
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DEP® Platform
Developing Targeted Therapies Through
Dendrimer Technology
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G2 G3 G4 G5
Overview
• Extensive pharmaceutical dendrimer dataset backed by 20 years of IP
and know-how
• Clinically validated with over 350 patients treated across multiple clinical
programs
Proprietary DEP® technology to customise payloads drugs and/or
targeting moieties to overcome the most significant challenges in
drug development (efficacy, toxicity, pharmacokinetics)
• Demonstrated platform with favourable results across two phase 2 trials of
DEP® SN38 and DEP® Cabazitaxel
Broad application across a range of treatment modalities
Our DEP® Platform Technology
Global leader in dendrimer technology
Dendrimer Generations
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Challenges in RLT DEP® Dendrimer Solution
Limited tumour uptake, target binding
and/or retention
Suboptimal PK profile – too long or too
short circulation
Organ (kidney) uptake, retention and dose-
limiting toxicities
✓ Optimal targeting moiety and radionuclide
✓ Multivalent presentation of functional surface groups
(targeting moiety, PEG, payload)
✓ Tuneable PK with adjustable size and PEG shielding
✓ Optimal biodistribution with reduced kidney uptake
and retention
Enhanced Efficacy Enhanced Safety
Leveraging DEP®’s Competitive Advantage to Address Key
Radiotherapy Challenges
DEP® delivers clear benefit in radioligand therapy
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• Rapid tumour binding
• Rapid accumulation and retention
(increased penetration in the tumour site)
• Minimised off-target effects
• Rapid blood clearance
• Reduced kidney retention
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Treatment paradigm + unmet need (HER2+ Stage 3-4 metastatic)
1L (HER2+ metastatic/
advanced)
2L (after trastuzumab-
based regimen)
3L+ (post-T-DXd)
Trastuzumab
(Herceptin®) +
chemotherapy
backbone (ToGA):
Trastuzumab
deruxtecan
(T-DXd/Enhertu®):
No FDA-approved
treatments
DEP® HER2-Lu opportunity
Trastuzumab
(Herceptin®)
Trastuzumab
deruxtecan (Enhertu®)
1st Line 2nd Line
Median Progression
Free Survival (PFS)
6.7 months 5.6 months
Median Overall Survival
(OS)
13.8 months 12.5 months
>36% of patients
are diagnosed in
advanced stage
Low 5-year survival rate for
advanced gastric cancer1
HER2 in gastric/GEJ cancer
• HER2 positivity is ~22% across
screened gastric/GEJ tumour
samples (with variation by
subtype and site)
Disease burden
• ~968k new gastric cancer cases
and ~660k deaths globally (2022)
• Outcomes remain poor in
advanced disease
Strategic expansion:
Opportunity for expansion to
HER2-low indications including:
• Metastatic breast cancer
(mBC)
Intended entry point:
locally advanced/metastatic
HER2+ gastric/GEJ cancers
Significant Unmet Patient Need in HER2+ Gastric Cancer
Uncontested opportunity in 3L treatment resistant HER2+ Gastric Cancer
7.5%
1. SEER 5-Year Relative Survival Rates, 2015-2021
Addressable market for HER2+
mBC & gastric/GEJ cancers:
~$17bnby 2030
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Preclinical Package Overview, Clinical Pathway,
and Expert Perspective
DEP® HER2
Preclinical Data
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DEP® HER2-lutetium is a Targeted Radioligand Therapy
Leveraging Dendrimer Technology
First-in-class HER2
Radiotherapy
Differentiated profile with potential to enhance tumour targeting and tolerability
DEP® HER2-lutetium Optimised Design:
Parameter Target Product Profile
Tumor Uptake Fast tumour accumulation
Tumor Retention Retention in tumor >48h
Renal Clearance Fast clearance, minimal accumulation
Blood Clearance
Effective clearance from blood / bone
marrow by 48h
Efficacy HER2high and HER2low expressing tumors
Indications
HER2 expressing cancers
(gastroesophageal, breast, etc.)
HER2-targeting
nanobody (VHH)
Surface PEG
DOTA-Lutetium-177
DEP® Dendrimer
Scaffold
DEP® HER2-lutetium Schematic
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Biodistribution is Controlled by Dendrimer Design
DEP® radioligand therapy – customisable, optimised biodistribution
0
40
68Ga, dynamic PET/CT (0-3h), naïve (non-tumour-bearing) mice
Smaller Dendrimer Larger Dendrimer
Kidney Excretion Longer Circulation Time
10
DEP® Dendrimer Platform Provides the
Ability to Tailor Biodistribution
Signal
Intensity
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MW (kDa)
DEP® HER2-lutetium
Optimised size, biodistribution,
activity and tolerability
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T = SKOV3 (HER2+) tumour
K = kidneys
4 hours
T
DEP® HER2-Lu
T
HER2-VHH-Lu
48 hours
T T
K K
5 days
T T
12 days
T T
K
DEP® HER2-lutetium Achieves Strong Uptake & Retention in
HER2+ Tumors
Strong tumour uptake and prolonged tumour retention with low kidney exposure
DEP® HER2-Lu
HER2-VHH-Lu DEP® HER2-Lu
HER2-VHH-Lu DEP® HER2-Lu
HER2-VHH-Lu
2D SPECT imaging showing actual radiation signal (intensity) over time (Images not corrected for decay). SKOV3 is a HER2-high expressing
cancer cell line. Mice (n=3 per group) dosed with 15 MBq of radioactivity.One representative mouse is shown per group per timepoint.
• DEP® HER2-Lu vs. radiolabelled HER2-targeting VHH without dendrimer, HER2-VHH-Lu
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0 48 96 144 192 240 288
0
10
20
30
40
50
Time post-dose (hours)
Radioactivity
(%ID/g)
Ex vivo biodistribution, SKOV3 tumour-bearing mice, n=3 per timepoint dosed with 15 MBq radioactivity; ID/g = injected dose (radioactivity) per gram of tissue; data are mean ± SEM
DEP® HER2-Lu Blood Clearance
Fast clearance from blood
(%ID/g)
Ratio
in
Tumour
vs.
Tissue
48 hours
5 days
12 days
(%ID/g)
48 hours
5 days
12 days
Strong tumour uptake
and prolonged retention
Low kidney exposure
DEP® HER2-lutetium Achieves Strong Uptake & Retention in
HER2+ Tumors
Fast blood clearance, minimal kidney exposure and favourable tumour to tissue ratios
DEP® HER2-Lu Biodistribution
Tumour radioactivity
~150 times higher than blood
Radioactivity in the
tumour vs:
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0 10 20 30 40 50 60
0
20
40
60
80
100
Time post-dose (Days)
Survival
(%)
***
*
**
13
0 10 20 30 40 50
0
500
1000
1500
Time post-dose (Days)
Tumor
volume
(mm
3
)
***
DEP® HER2-lutetium Achieves Significant Anti-tumour Activity
and Survival Benefits
Durable tumour growth control and survival benefits that are comparable to Enhertu®
Mice (n=8 per group) dosed IV on Day 0. SKOV3 is a HER2-high expressing cancer cell line. Tumour volume curves displayed until volume of tumour in the first mouse in each group
reaches volume endpoint (1500 mm3). Study terminated Day 57. Tumour volume data are mean ± SEM and analysed by ordinary one-way analysis of variance (ANOVA) with Dunnett’s
multiple corrections on tumour growth inhibition (Day 21-Day 0) at Day 21. ***P<0.001 for DEP® HER2-Lu (15 and 25 MBq) and T-DXd (Enhertu®) vs Vehicle (phosphate buffered saline,
PBS) and HER2-VHH-Lu. Survival data are analysed by Logrank (Mantel-Cox)test between two groups. *P<0.05, **P<0.01 and ***P<0.001 for each group vs. Vehicle and HER2-VHH-Lu.
Anti-tumour Activity Survival Benefit
DEP® HER2-Lu (25 MBq)
DEP® HER2-Lu (25 MBq)
50% survival @d57
Enhertu® (10 mg/kg)
12.5% survival @d57
• HER2-positive (high-expressing) cancer model; DEP® HER2-Lu (25 MBq) and DEP® HER2-Lu (15 MBq) vs. Enhertu®, HER2-VHH-Lu and
Vehicle (PBS, saline)
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0 20 40 60 80 100
0
20
40
60
80
100
Time post-dose (Days)
Survival
(%)
*
*
0 20 40 60 80 100
0
500
1000
1500
2000
Time post-dose (Days)
Tumor
volume
(mm
3
)
****
**
*
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DEP® HER2-lutetium Benefits Extend to HER2-low expressing
tumours
Findings support future evaluation across a broader HER2-expressing patient population
Mice (n=8 per group) dosed IV on Day 0. Capan-1 is a HER2-low expressing cancer cell line. Tumour volume curves displayed until volume of tumour in the first mouse in each group
reaches volume endpoint (2000 mm3). Study terminated Day 84. Tumour volume data are mean ± SEM and analysed by ordinary one-way analysis of variance (ANOVA) with Dunnett’s
multiple corrections on tumour growth inhibition (Day 25-Day 0) at Day 25. *P<0.05 for DEP® HER2-Lu (15 MBq), **P<0.01 for DEP® HER2-Lu (25 MBq) and ****P<0.0001 for T-DXd
(Enhertu®) vs Vehicle (phosphate buffered saline, PBS). Survival data are analysed by Logrank (Mantel-Cox)test between two groups. *P<0.05 for each group vs. Vehicle.
Anti-tumour Activity – HER2-low Survival Benefit – HER2-low
DEP® HER2-Lu (25 MBq)
87.5% survival @d84
Enhertu® (10 mg/kg)
62.5% survival @d84
• HER2-low expressing cancer model; DEP® HER2-Lu (25 MBq) and DEP® HER2-Lu (15 MBq) vs. Enhertu® and Vehicle (PBS, saline)
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DEP® HER2-lutetium Preclinical Summary
A novel, radiopharmaceutical asset targeting cancers with high unmet need
15
DEP® HER2-lutetium Radioligand Therapy (RLT) Asset
Dendrimer-based nanobody radioligand targeting HER2-expressing cancers (gastric & metastatic breast) with high unmet need
Optimized Biodistribution
• Fast blood clearance and minimal kidney
accumulation
• Strong tumor uptake and retention in
HER2high and HER2low models
Efficacy
• Significant tumor reduction and survival
benefit vs. control (HER2high [SKOV3],
HER2low [Capan-1] mouse models)
Safety
• Favorable tumor-to-tissue ratios and low
off-target toxicity
Key Differentiators
1 Potential first radioligand therapy for
HER2-expressing tumors
2 Nanobody-dendrimer format:
• High tumor uptake
• Low kidney uptake
• Rapid blood clearance
3 Broad application across HER2high
and HER2low expressing tumors
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Clinical Development Strategy
Significant unmet need offers potential for Accelerated Approval
FIH / Phase 1
(Imaging, dosimetry, and mass dose
determination – Up to 15 patients)
Phase 1/2
(Dose escalation/confirmation, expansion
cohorts, efficacy, safety, up to 40 patients)
Pivotal Study Phase 2/3
(Registrational, potential Fast Track – up to
250 patients)
FDA Type B Pre-IND Meeting
Registration
H2 CY26
First patient dosed
H2 CY27
Topline readout for up to 15
patients from FIH/Ph 1
Ph 1/2 (IND) begins
H1 CY27
Initial data readout
First 3-4 patients
CY28
Phase 2/3 ready POTENTIAL FOR ACCELERATED APPROVAL
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Objectives
• Confirm tumour targeting
• Optimise mass-dose and
biodistribution
• Assess safety, PK and
dosimetry
Endpoints
• PK and tumour uptake
• Biodistribution /
dosimetry
• Safety & tolerability
Next Steps
• First patient H2 CY26
• Initial data H1 CY27
• Topline Phase I data H2
CY27
• Pre-IND/IND
• Advance to Phase 1/2
expansion cohorts
First-in-human Phase 1 Clinical Study
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Consistent Results Across Multiple Oncology
Targets
DEP® Platform
Exemplification
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DEP® Radiopharmaceutical Platform Exemplified Across
Multiple Targets
HER2-targeted lead asset supported by broader platform exemplification and strong IP position
Cross-target DEP® biodistribution dataset
• Exemplification of the DEP® radiopharmaceutical
platform across multiple oncology targets, including
PSMA and EGFR
• Cross-target data support the modularity of the DEP®
approach and its potential application across multiple
targeting strategies
• A new patent application covering DEP® dendrimer
technology in radioligand therapy strengthens
Starpharma’s platform IP position
Insert speaker name and title here 19
vivo Biodistribution at 48h
Radioactivity
(%ID/g)
DEP®
HER2
DEP®
PSMA
DEP®
EGFR
DEP® HER2 is the lead clinical opportunity, with HER2, PSMA and EGFR data collectively
supporting a broader, IP-protected radiopharmaceutical platform
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Cross-Target Data Support Broad DEP® Platform Opportunity
HER2, PSMA and EGFR constructs show tumour-focused biodistribution and favourable tumour-to-tissue profiles
• Consistent tumour uptake observed across HER2-, PSMA- and EGFR-targeted DEP® constructs
• Favourable tumour-to-tissue ratios observed across key healthy tissues
• Body-weight data provide supportive tolerability context over the observed period
• Cross-target consistency supports broader DEP® platform potential
Insert speaker name and title here 20
Tumor Kidney Liver Lung Spleen Muscle
0
10
20
30
ex vivo biodistribution - 48h post dose
Radioactivity
(%ID/g)
DEP®
HER2
DEP®
PSMA
DEP®
EGFR
Kidney Liver Lung Spleen Muscle
0
10
20
30
Radioactivity
(%ID/g)
Ratio
in
Tumor
vs.
Tissue
DEP®
HER2
DEP®
PSMA
DEP®
EGFR
Tumour to tissue ratio - 48h post-dose
D0 D2 D5 D6 D8 D12
80
90
100
110
120
Body Weight
Time post-dose (Days)
Body
weight
(%
of
baseline)
DEP®
EGFR
DEP®
HER2
DEP®
PSMA
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DEP® Radiopharmaceutical Data Supports New Patent Filing
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Differentiated preclinical profile strengthens platform IP and partnering potential
Differentiated Profile
• Enhanced tumour uptake and retention
• Low off-target and kidney exposure
• Rapid blood clearance and renal
excretion
Broad, Modular Platform
• Consistent data observed across HER2,
PSMA and EGFR
• Potential for an improved therapeutic
window
• Applicable across multiple tumour
types
~US$8bn → ~US$15bn
Global radiopharmaceutical market by 2030*
Radiopharmaceuticals are one of the fastest-growing areas of precision oncology,
attracting significant strategic interest and partnering activity from global
pharmaceutical companies.
IP & Partnering Upside
• New patent filed for DEP® in radioligand
therapy
• Protects the DEP® technology across
multiple targets
• Supports parallel partnering programs
* https://www.marketsandmarkets.com/Radiopharmaceuticals-market-research-255.html
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Scientific Advisors and Strategic Partners
Global Radiopharmaceutical Experts
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Scientific & Clinical Advisors: Strategic RLT Partners:
Elisabeth (Liesbeth)
de Vries, M.D., Ph.D.
• Professor of Medical
Oncology, University
Medical Center
Groningen (UMCG),
Netherlands
• Molecular imaging,
breast cancer drug
research, HER2-
targeted imaging and
therapy
Gary A. Ulaner,
M.D., Ph.D., F.A.C.N.M
• James & Pamela Muzzy
Endowed Chair of
Molecular Imaging and
Therapy, Hoag Family
Cancer Institute;
Clinical Prof. Radiology
& Cancer Biology, Keck
School of Medicine,
USC; President-Elect of
SNMMI
• Molecular imaging and
theranostics; pioneer in
PET radiotracers
Tony Lahoutte,
M.D., Ph.D.
• Physician & Head of
the Dept. of Nuclear
Medicine, UZ Brussel;
Head of Molecular
Imaging and Therapy
Research at Vrije
Universiteit Brussel;
• Co-founder of RLT
companies
• Nanobody-based
imaging, radionuclide
therapy expert
Tracer CRO
• RLT CRO focused on
first-in-human trials
using nuclear & optical
molecular imaging
• Optimal clinical trial
design via streamlined
biodistribution and
imaging studies;
EMA/FDA-compliant
early human data for
oncology assets
Bracken Group
• Life science consultancy
with deep expertise in
radiopharmaceutical
regulatory strategy,
development, clinical
trial design and
operations
• Strategic regulatory and
clinical advisors
University of Qld/ AMTAR
• The AMTAR Hub, an ARC-
funded research centre at
University of Queensland, is
focused on developing
manufacturing technologies for
targeted radiopharmaceuticals
• Prof. Kristofer Thurecht &
colleagues support
Starpharma’s DEP®
radiotheranostics program
through AMTAR, contributing
expertise in translational
radiopharmaceutical
development.†
Yelena Janjigian, M.D.
• Chief, Gastrointestinal
Oncology Service,
Memorial Sloan
Kettering Cancer
Center; Professor at
Weill Cornell
• Gastric and esophageal
cancers;
immunotherapy and
HER2-targeted
strategies; translational
research and global
clinical trial leadership
† Work conducted under the AMTAR collaboration was supported by the Australian Government through the Australian Research Council (IH220100017)
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Professor Tony Lahoutte, MD, PhD
Physician and Head of the Department of Nuclear Medicine,
University Hospital (UZ), Brussel
Head of Molecular Imaging and Therapy Research (MITH) at the
Vrije Universiteit Brussel (VUB) in Belgium
Co-founder of companies developing targeted radioligand therapies
Expertise includes nanobody-based imaging, radionuclide therapy
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KOL Perspective – Professor Tony Lahoutte
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Q&A
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Upcoming Catalysts
• Commencement of the Phase 1 study in H2 CY2026
• Early clinical data, particularly safety, biodistribution, dosimetry and tumour uptake in 1H CY2027
• Topline data from FIH Phase 1 in H2 CY2027
• Continued progress in the broader DEP® radiopharmaceutical platform
• Expansion of partnership opportunities
DEP® Radio Milestones
What to expect in the following 12-18 months
25
I N V E S T O R W E B I N A R J U L Y 2 0 2 6
Phase 1 Start
H2 CY2026
Early Clinical Data
1H CY2027
Topline Data
CY2027
Platform & Partnerships
Ongoing
I N V E S T O R P R E S E N T A T I O N M A Y 2 0 2 6
Thank you
Investor Relations
Investor.Relations@Starpharma.com
www.starpharma.com
Corporate Office
4 – 6 Southampton Crescent
Abbotsford, Victoria 3067
Australia
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