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I m a g i o n B i o s y s t e m s L i m i t e d
A S X : I B X
S e p t e m b e r 2 0 2 6
Molecular MRI:
The Next
Generation
of Imaging
B R E A K T H R O U G H F O R E A R L Y C A N C E R D E T E C T I O N
Forward Looking Statements
This investor presentation(Presentation) has beenprepared by ImagionBiosystemsLimited (Imagionor the
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2 IBX Investor Deck | ImagionBiosystems.com
• Clinical Stage Biotech in Phase 2 of clinical investigations
• Highly Differentiated and first-of-its-kind for cancer detection
• Next Generation Tech able to challenge the radiopharmaceutical market
Changing How We See Cancer
C O M P A N Y O V E R V I E W
Strong Pipeline Addressing Large Markets
Lead Indication:
Prostate Cancer Ovarian Cancer
HER2 Breast Cancer
(FDA IND Clearance – June 2026)
Additional Key Target Indications Include:
3 IBX Investor Deck | ImagionBiosystems.com
Screening
• Blood-based tests indicate risk but are non-diagnostic and require
confirmation before treatment
Current Diagnosis Takes Too Long
T H E U N M E T M E D I C A L N E E D
Biopsy
• Provide certainty but are invasive, painful, error prone and challenging,
often resulting in side effects or complications
• Pathology assessments can take days
Conventional Imaging
• Non-invasive but non-specific: cannot differentiate
benign lesions from malignant tumors with certainty
• Gadolinium-based contrast agents are not able to be
molecularly targeted
MagSense® imaging agents combined with MRI’s
high resolution delivers clearer, more confident
imaging to support earlier, more definitive
diagnoses.
M O L E C U L A R M R I
MagSense particles are coated with unique
targeting moiety specific to a particular type
of cancer
MagSense particles are administered
before an MRI and only bind to targeted type
of cancer cells, if present
MagSense produce an identifiable change
in image contrast, which is easily detected
even when tumors are small and at their
earliest stages
STANDARD MRI MagSense® MRI
Radiologist are able to see a CHANGE IN INTENSITY and the
spotty pattern resulting when the MagSense imaging agent is
present in the tissue
Earlier, More Accurate
Cancer Detection
Lesion or node is
irregular in size or shape
and considered
“suspicious”
The change in contrast
indicates cancer cells
are present
MagSense® Imaging Agents Can Be
Applied to Many Types of Cancer
P L A T F O R M T E C H N O L O G Y – A D D I T I O N A L I N D I C A T I O N S
• All MagSense agents work the same, making the regulatory path clear
and commercialization and adoption easier
• Changing the MagSense targeting molecule allows for detection of
different types of cancer
• Fits existing clinical workflows and are compatible across 50,000+ MRI
scanners in use globally
Early Detection of Prostate Cancer
• 1M+ Prostate biopsies/year in US
• mpMRI = >50% False Positive rate & >15%
False Negative rate
• PSMA-PET not typically used for primary
tumor detection: exposes patients
to radioactivity
Early Detection of Ovarian Cancer
• >300,000 women/yr. diagnosed with
ovarian cancer; ~2/3rds die from the
disease
• 75% of cases diagnosed at late stage
• CA-125 blood tests indicate risk but are
not predictive of disease
• “Watchful waiting” by ultrasound is the
existing standard of care
Pre-Dose Post-Dose
MagSense Ovarian Cancer targeted particle
Preclinical xenograph tumor model
6
The Phase 1 Trial in HER2 Positive Breast
Cancer Subjects Met All Endpoints1
C L I N I C A L D E V E L O P M E N T
• Phase 1 trial conducted in patients with HER2+ breast
cancer (N=13)
• Imaging agent was generally safe and well tolerated in
all patients
• Blinded review by independent expert panel of
radiologists corroborated detectable magnetic signature
Baseline Post-MagSense®
Central radiologists called the node “Indeterminate”at
baseline and then “Suspicious” post MagSense® imaging,
potentially providing true positive finding.
Data indicated that
MagSense aided in:
• Identification of axillary
lymph nodes; and
• Discrimination of tumor
containing lymph nodes
from normal lymph nodes
• May improve on ultrasound
limitations; and
• Could reduce need for
Sentinel Lymph Node Biopsy
and Axillary Lymph Node
Dissection
1) ASX release 18 October 2023
7
Baseline Post-MagSense®
Central radiologists called the node “Suspicious” at
baseline and then “Normal” post MagSense imaging,
potentially eliminating false-positive finding.
Part A Blood samples taken
post dose
PK
N= 3-10 Objective:
Establish further safety profile of MagSense
Part B MRIs taken at multiple time points to
identify optimal imaging time
ImagingSchedule
N= 10-20 Objective:
Establish lowest dose and post dose imaging schedule
Part C MRI @ optimum time based on Parts A & B
Diagnostic
Performance
N=40
Objective:
Compare diagnostic performance to Standard of Care
Anticipated ~3-6 mos.
Anticipated ~6 mos.
Anticipated ~12 mos.
The Phase 2 HER2+ Clinical Trial
C L I N I C A L D E V E L O P M E N T
Key Near Term Activities:
• Contract 1st clinical site(s) after completing local institutional reviews
• Activate site(s) after training on the study protocol and procedures
• Open the trial for enrolment and initiate patient recruiting into the trial
• First Patient In – dosing of the first patient in Part A
• Undertake a Safety Review following the first 3 participants
IND
Cleared by
FDA
The Next Generation
of Molecular Imaging
R A D I O P H A R M A C E U T I C A L S &
C O N T R A ST M E D I A M A R K E T L E A D E R S
✓ Gadolinium-Based Contrast Agents
improve contrast for high resolution
Risk of higher false positives because it is
not specific: both benign and malignant
lesions become enhanced
Cannot achieve molecular targeting
because of low relaxivity of gadolinium
✓ High sensitivity
✓ Can be molecularly targeted though
limited by tracer half-life
Uses Radioactivity
Poor Resolution
✓ No radioactivity: safer for patients and providers
✓ Easier to manufacture & distribute
✓ Works with large installed base of MRI’s
✓ Can be applied to many types of cancer or other
diseases
✓ “Theranostic” ready platform able to expand to drug
delivery and therapies
Contrast Enhanced MRI PET MagSense® mMRI
N O N - R A D I O P H A R M A C E U T I C A L
T H E R A N O ST I C S
• Global cancer incidence to rise
77% by 2050 with screening &
diagnostic imaging costs
growing at 6.7% CAGR
• Molecular imaging to-date
limited to methods using
radioactivity due to MRI lacking
specificity
• US$2.1 billion target market for
lead indications with upside in
theranostics and drug delivery
Investment Rationale
• High rate of contrast media
products achieve regulatory
approval (almost 100%)
• Imagion Phase 1 clinical data
support safety and detectability
• Platform technology - all
MagSense® imaging agents work
the same
LARGE MARKETS WITH AN UNMET
MEDICAL NEED REDUCED TECHNICAL RISK UPSIDE LEVERAGE
• Large ASX Peer Valuations,
Potential for Strategic Partnering
• ASX radiopharmaceutical
companies with multi $B market
cap; IBX developing 2.0
proprietary imaging tech
• Health economics support
value-based reimbursement
pricing while still saving
healthcare system costs
• High gross margins support
commercial partnering business
model
Company Leadership
Robert Proulx MAICD
Executive Chairman
Robert isan operationally oriented executive with over
30 years in life science &medicaldevice product
development &commercialisation
Experienced team across
development & commercialisation
of drug & device products
Track record of successful
marketing approvals
Melanie Leydin CA FGIA
Co.Sec. and Non-Executive Director
Melanie is a Chartered Accountant &a Fellowof the
Governance Institute of Australia. She is currently the
Managing Director of Vistra Australia
Nina Webster PhD, MBA, M.IP.Law
Non-Executive Director
Nina is an experienced pharmaceutical &biotech
executive acrossstrategic planning, scientific &
operational execution & commercialisation
Brett Mitchell
Non-Executive Director
Brett isan experiencedASX directorandcorporate
finance executive with over 25 years of experience in the
venture capital andequity capital markets
Ward Detwiler MBA
President of US Subsidiary
Wardisan experiencedseniorexecutive in the
medical imaging field. Most recently, he wasco-
founder andCEOof SpinTech MRI
Dr. Susan Harvey
Medical Affairs Advisor
Dr. Harvey is a breast radiologist and the co-founder of
CuringWomen’sCancer. Previously she servedas
Directorof Breast Imagingat Johns Hopkins Medicine
Dr. Kayat-Bittencourt
Clinical Advisor
Dr. Kayat-Bittencourt is the Vice Chair of
Innovation at University Hospitalsand an
Associate Professorof Radiology at Case
Western Reserve University
A B R E A K T H R O U H F O R
E A R L Y C A N C E R D E T E C T I O N
I m a g i o n B i o s y s t e m s L i m i t e d
A S X : I B X
i n f o @ i m a g i o n b i o . c o m IBX Investor Deck | ImagionBiosystems.com
• FIRST OF ITS KIND IN MOLECULAR MRI
• NEXT GENERATION TECH TO DISRUPT
RADIOPHARMACEUTICAL MARKET
• MULTIPLE INDICATIONS IN
DEVELOPMENT
• MULTI-BILLION DOLLAR MARKET
OPPORTUNITY
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