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TRIVARX LTD — Capital/Financing Update 2025
Dec 21, 2025
65950_rns_2025-12-21_b88065a9-4bae-49f0-8c7c-f2e0a580ca89.pdf
Capital/Financing Update
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ASX ANNOUNCEMENT
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22 December 2025
Second-tranche placement funding provides strong financial flexibility to advance Stabl-Im technology for the early and safe detection of brain tumours
Highlights:
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$3.5m second-tranche placement funding received, strengthening TrivarX’s balance sheet and providing flexibility to advance Stabl-Im into the clinic
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Funding to progress Stabl-Im preparatory activities, including manufacturing scale-up, quality-control validation and regulatory pre-submission work in the US and EU
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Stabl-Im targets early, safe and non-invasive detection of brain tumours, using stable isotope labelling and standard MRI without radiation or surgery
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First-in-human Phase 1 clinical trial planned for CY26, focused on safety, imaging precision and reproducibility in patients with confirmed brain tumours
Perth, Australia, and Minneapolis, USA: TrivarX Limited (‘the Company’ ) (ASX: TRI) is pleased to advise it has received $3.5m in new funding following settlement of the second tranche of the Company’s strategic placement (refer ASX announcement: 16 October 2025). New funding provides TrivarX with balance sheet strength and exceptional financial flexibility to advance development of Stabl-Im.
Stabl-Im represents a potential breakthrough in the safe and non-invasive imaging of brain cancers and metastases. The platform utilises stable isotope labelling to identify replicating cells within the brain, which is a biological process that is absent in healthy adults but rapidly activated in the presence of a growing tumour. The platform detects cellular replication using standard Magnetic Resonance Imaging (MRI) equipment, providing a safe and non-invasive method to visualise and monitor tumour growth, without the need for radiation or surgical procedures.
New funding will be deployed towards targeted preparatory activities to advance the Stabl-Im platform into the clinic. This will include manufacturing scale-up and quality-control validation of the stable isotope compounds used in imaging, together with regulatory pre-submission activities across key jurisdictions, including the US and European Union.
These activities will be overseen by experienced regulatory and medical consultants, working alongside existing management, to support clinical pathway design and ensure alignment with applicable regulatory frameworks. The Company will also be supported by Dr Daniel Tillett, founder of Stabl-Im, who has agreed to provide ongoing technical input and advice across preclinical and clinical study activities.
A first-in-human Phase 1 clinical trial is expected to commence in CY26, with the objective of assessing safety, imaging precision and reproducibility of the Stabl-Im platform in patients with confirmed brain tumours. Interim study results and preliminary safety data are expected to inform progression toward broader, multi-site clinical trials.
A presentation providing further background on the technology and clinical development pathway is attached to this announcement.
This announcement is authorised for release by the Board of Directors of TrivarX Limited.
ENDS
TrivarX Limited (A.B.N. 58 008 130 336) 647 Beaufort Street, Mount Lawley, WA 6050
ASX ANNOUNCEMENT
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Investor Enquiries:
Henry Jordan – Six Degrees Investor Relations [email protected] +61 431 271 538
About TrivarX Limited:
TrivarX (ASX: TRI) (OTCPINK: MDBIF) is a mental health technology company pioneering the use of objective measures to aid in the early detection and screening of mental health conditions. The Company was founded in Australia, with offices located in Perth (WA) and Minneapolis (MN, USA). TrivarX is listed on the Australian Securities Exchange Ltd and trades on the OTCQB Venture Market. Investors can find additional information on www.otcmarkets.com and www.asx.com.au
TrivarX Limited (A.B.N. 58 008 130 336) 647 Beaufort Street, Mount Lawley, WA 6050
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Investor Presentation – December 2025
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ASX: TRI
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Forward looking statements
The purpose of the presentation is to provide an update of the business of TrivarX Limited (ASX: TRI). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification.
Accordingly, these slides and the information they contain should be read in conjunction with past and future announcements made by TrivarX Limited and should not be relied upon as an independent source of information. Please contact TrivarX Limited and/or refer to the Company's website for further information. The views expressed in this presentation contain information derived from publicly available sources that have not been independently verified.
None of TrivarX Limited, or any of its affiliates or associated companies (or any of their officers, employees, contractors or agents (the Relevant Persons) makes any representation or warranty as to the accuracy, complete-ness or reliability of the information, or the likelihood of fulfilment of any forward-looking statement or any out-comes expressed or implied in any forward-looking statements.
Any forward-looking statements in this presentation have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside TrivarX Limited’s control. Important factors that could cause actual results to differ materially from assumptions or expectations expressed or implied in this presentation include known and unknown risks.
Actual results could differ materially to the assumptions made and TrivarX Limited’s current intentions, plans, expectations and beliefs about the future. You are urged to view all forward looking statements contained in this presentation with caution. Except as required by applicable law or the ASX listing rules, the Relevant Persons disclaim any obligation or undertaking to publicly update any statements in this presentation, whether as a result of new information or future events.
This presentation should not be relied on as a recommendation or forecast by TrivarX Limited. This presentation does not constitute investment advice or should be construed as either an offer to sell, or a solicitation of an offer, to buy or sell shares in any jurisdiction.
Investor Presentation – December 2025
02
Stabl-Im : A potential breakthrough in the safe and non-invasive imaging of brain and other cancers
Acquired in December 2025 from Nucleics Pty Ltd
Technology has potential to enable safe imaging and monitoring of brain cancers through standard MRI
Stabl-Im uses stable isotope labelling of replicating cells within the brain for earlier detection of brain tumours
Technology invented by Dr Daniel Tillett, a prominent biotech investor, industry leader and the CEO & Managing Director of Racura Oncology (formerly Race Oncology) Limited (ASX: RAC)
Defined pathway to market with immediate works program to include manufacturing and quality control, FDA engagement and Phase 1 clinical trial early CY26
Stabl-Im has the potential to address the limitations of the current standard of care
Investor Presentation – December 2025
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An opportunity to disrupt major markets
- Innovative technology to pursue significant opportunities in the diagnostic imaging and neuro-oncological markets
MARKET OVERVIEW
KEY DRIVERS
Global diagnostic imaging market ~US$600bn+ , with MRI a high-value, fast-growing segment
Increasing cancer survival rates
Global MRI market ~US$10–12bn , growing ~ 6–7% CAGR , underpinned by oncology and neurology
- >40 million MRI scans annually , creating strong leverage for innovations using the existing installed base
MRI is the gold standard in neuro-oncology , yet limited in distinguishing active tumour from treatment effects
- ~180,000 brain metastasis cases annually in the US , with rising incidence and high unmet diagnostic need
Better diagnostic imaging capabilities
Growing aging population
Lung and breast cancer prevalence
Stabl-Im addresses this gap by enabling functional, non-radioactive tumour imaging on standard MRI systems
Critical unmet need: Despite advances in treatment, survival rates remain poor following brain metastases diagnosis, with most patients having short life expectancy. Early, safe and accurate detection is essential
Investor Presentation – December 2025
04
Current standard of care
• Contrast-enhanced MRI is the gold standard for brain metastases detection and monitoring
- A PET (positron emission tomography) scan is used as an adjunct, particularly to differentiate progression from treatment effect
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CONTRAST-ENHANCED STABL-Im MRI PET SCAN
MRI
Poor small lesion detection
High-sensitivity
Lesion detection >3mm
resolution
Uses radioactive isotope -
Lesion detection
Relies on blood brain No radiation not naturally metabolised
barrier disruption <3mm
exposure
Radiation exposure
Stable isotope Metabolic
Anatomical changes Safe for
detection
High brain background
frequent
Does not detect Naturally uptake (masks metastases)
monitoring
metabolised
metabolically active or
replicating cells Clear tumour- Limited frequency of
monitoring
to-background
Up to 1 hour contrast
2-3 hours
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Stabl-Im has the potential to combine the metabolic detection capabilities of PET with the safety, resolution and infrastructure advantages of MRIs to provide early response assessment and monitor progression frequently.
Investor Presentation – December 2025
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Magnetic Resonance Imaging (MRI) overview
MRI is an imaging technique that uses high magnetic fields and radio waves to visualize soft tissue – It has many applications but inherent limitations in detecting some diseases
THE MRI PROCESS
A strong magnet lines up hydrogen in the body
Radio waves briefly knock this alignment out of place As the hydrogen settles back, it sends signals to the scanner Different tissues send different signals (e.g. water vs fat) This allows MRI to tell tissues apart
But MRI mainly shows structure, not cell activity
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Non-dividing cells (e.g. brain)
Stabl-Im
cell cell
Dividing cells (e.g. cancer)
Stabl-Im cell
cell
cell
cell
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MRI signal
MRI signal
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Stabl-Im is incorporated
into dividing cells:
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Investor Presentation – December 2025
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Introducing Stabl-Im – Stable Isotope MRI
Innovative technology that offers a potential breakthrough in the safe and non-invasive imaging of brain cancers
Stabl-Im uses stable isotope labelling to identify rapidly dividing cancer cells in the brain through standard MRI equipment – offering a radiation-free, non-invasive diagnostic approach
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Administration
Patient receives
Stabl-Im orally
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Rapidly replicating tumour
Stabl-Im incorporates into
KEY ADVANTAGES
No radiation exposure Uses existing MRI equipment Detects metabolically active tumours Can monitor treatment response Repeatable for longitudinal tracking
TECHNICAL FEATURES MRI is a non-radioactive imaging technique Identifies replicating cells specifically Differentiates tumours from normal tissue
Investor Presentation – December 2025
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Safety in Humans
Previously studies highlight that Stabl-Im is safe in animals, as well as humans, providing a strong foundation for planned Phase 1 clinical trial
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SAFETY ASPECTS
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Stabl-Im is known to be safe in animals at up to 20% with no health even when consumed across impacts, multiple generations Limited study in humans, however, initial human research has shown no effects at up to 3% The highest human dose is currently unknown Determining the safest human Stabl-Im dose will provide further IP, which will be protectable by patent
No radiation (unlike PET scans) No cumulative radiation exposure Safe for repeated imaging sessions No special handling requirements Suitable for a broader patient populations
Investor Presentation – December 2025
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Clinical and regulatory pathway
Defined phase 1 regulatory pathway and near term works program provides a compelling value proposition underpinned by the potential to materially improve clinical outcomes
Clear Phase 1 regulatory pathway: Stabl-Im is a stable, non-radioactive isotope classified as a food, supporting a streamlined early-stage regulatory approach
High-unmet orphan indication: Brain metastases affect ~180,000 patients annually in the US, carry a very poor prognosis, and have limited, highly invasive treatment options
Strong orphan designation potential: Orphan Drug Designation offers 7 years post-approval exclusivity, applicable to diagnostics as well as therapeutics
Stepwise clinical program includes: Preclinical animal studies to optimise dMRI parameters, Phase 1 dose-escalation safety study in healthy volunteers, Phase 1/2 dMRI imaging trial in patients with suspected brain metastases and tumours
Efficient trial execution: Patient population is typically excluded from trials, allowing simpler recruitment and faster progression
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Clinical: Phase 1 / 2 dMRI
Preclinical: Animal studies to Clinical: Phase 1 dose escalation
imaging trial in patients with
determine dMRI parameters safety study in healthy volunteers suspected brain metastasis and
tumours
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Investor Presentation – December 2025
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Stabl-Im presents major advantages
Technology, potential efficiency of clinical trials and shorter-term regulatory pathway provides a considerable potential upside
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Non-radioactive MRI-based detection of rapidly growing cells (i.e. cancer) has the potential to considerably impact clinical decision making, unlock earlier intervention and improve quality of life
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$4.2m funding secured for development with Phase 1 planned in H12026
No chemistry, manufacturing, control (CMC) requirements – unlocking massive cost savings
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Stabl-Im is known to be safe at low levels – IP (patent) obtainable from identifying the upper safety limits in humans via pending Phase 1 trial
Can be delivered anywhere in the body – no issues with the blood brain barrier or fibrotic tumours – highly important for brain and other cancers
Patients can be screened as often as desired without the use of radiation or contrast agents. Can potentially be used to determine the activity of cancer treatments more regularly unlocking multiple commercial opportunities
Investor Presentation – December 2025
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Multiple near term value drivers
Defined works programs underpin potential for significant near term value creation
| Activity | Timing |
|---|---|
| Key appointments to strengthen management team | January 2026 |
| Completion of pre-clinical trial design requirements | January 2026 |
| Commencement and completion of pre-clinical trial using Stabl-Im in animal studies | Q1 CY2026 |
| Completion of Phase 1 clinical trial design and requirements | Q1 CY2026 |
| Ethics approval for Phase 1 dose escalation study in healthy human volunteers | Q2 CY2026 |
| Commencement of patient recruitment for Phase 1 study | Q3 CY2026 |
| Undertake Phase 1 study in healthy human volunteers | Q3 CY2026 |
| Completion of Phase 1 study | Q3 CY2026 |
| Advance regulatory engagement initiatives with the US Food & Drug Administration | Q4 CY2026 |
Investor Presentation – December 2025
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CONTACT
TrivarX Limited (ASX: TRI) E: [email protected] A: 647 Beaufort Street, Mt Lawley, WA 6050 Kai Sun – Chief Operating Officer: T: +61 433 549 602 E: [email protected] Henry Jordan – Six Degrees Investor Relations T: +61 431 271 538 E: [email protected]
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