AGM Presentation
Released
Released
Announcement PDF
ANNUAL GENERAL
MEETING
November 2025
ASX: IVX
Next Generation Photodynamic Therapy (PDT)
for Cancers and Infectious Diseases
2
DISCLAIMER
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 Invion Limited (Company). In preparing this presentation, the
Company did not take into account the investment objectives, financial
situation and particular needs of any particular investor. Further advice
should be obtained from a professional investment adviser before taking
any action on any information dealt with in the presentation. Those acting
upon any information without advice do so entirely at their own risk. 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 information or those opinions or for any errors,
omissions, misstatements (negligent or otherwise) or for any communication
written or otherwise, contained or referred to in this presentation.
Accordingly, neither the Company nor any of its directors, officers,
employees, advisers, associated persons or subsidiaries are liable for any
direct, indirect or consequential loss or damage suffered by any person as
a result of relying upon any statement in this presentation or any document
supplied with this presentation, or by any future communications in
connection with those documents and all of those losses and damages are
expressly disclaimed. Any opinions expressed reflect the Company’s
position at the date of this presentation and are subject to change.
INVION AT CLINICAL INFLEXION POINT
3
PLATFORM TECHNOLOGY & PARTNERSHIPS
Progressing Clinical Programs
Invion is well advanced in its clinical program across multiple cancer
types with encouraging early results
Platform Technology
Significant progress highlighting the potential of Photosoft as a
platform technology with multiple uses in human and animal health
Key Partnerships
Industry partnerships providing non-dilutive funding and expertise to
develop Photosoft, which complement Invion’s collaboration with world
renowned research institutes (e.g. Peter Mac and Hudson Institute)
Photosoft is only
activated by
specific
wavelengths of
light to selectively
regress or
fluoresce cancers
CONTINUED CLINICAL MILESTONES & PARTNERSHIPS
YEAR OF ACHIEVEMENTS
4 2025 2026
Further Results Ph I/II Skin
Cancer Clinical Trial
Initiation Ph I/II Anogenital
Clinical Trial with Peter Mac
Update on HPV to PoC
Human Trial with Dr.inB
Update Companion Animal
Cancer Studies with Protect
GBM and/or oesophageal
update with Hanlim Pharm
Further Collaborations /
International
Achievements in 2024-25
✓ Collaboration with Protect Animal Health
on companion animal cancers
✓ Secured Orphan Drug Designation
from US FDA for INV043 (anal cancer)
✓ Successful Ph 2 Prostate Cancer Clinical
Trial Results
✓ Encouraging early results for Ph I/II Skin
Cancer Trial
✓ Expanded collaboration with Hanlim
Pharm for Glioblastoma (Preclinical)
✓ Invion working with Peter MacCallum
Cancer Centre (Peter Mac) on trial design
and other preparations for anogenital trial
✓ Prof Rob Ramsay from Peter Mac
appointed as Invion’s Scientific Advisor
PARTNERSHIPS
LUCRATIVE COMPANION ANIMAL MARKET OPPORTUNITY
COLLABORATION WITH PROTECT ANIMAL HEALTH
1) https://www.avma.org/resources/pet-owners/petcare/cancer-pets
2) https://www.zionmarketresearch.com/news/pet-cancer-therapeutics-market
New Market Potential
• First agreement in the companion animal cancer care market
• Reinforces Photosoft as a platform technology with multiple
market opportunities
• Invion has hundreds of proprietary Photosoft compounds in its
portfolio
Funded Studies
• Protect Animal Health to fund and undertake evaluation studies
• Work includes in vitro, in vivo and companion animal studies
• Invion will provide select Photosoft compounds and retains all
existing and new IP rights
Large Opportunity
• Fast growing market with ~50% of dogs over the age of 10
diagnosed with cancer
• Global pet cancer market forecast to grow 9.7% CAGR (2025-
2034) to US$12.1B
• Current treatments tend to be lengthy and use older cancer
therapeutics
• Potential for commercial agreement if evaluation is successful
Founded in 2019 by biotech
investors and animal-loving drug
developers
Protect Animal Health (PAH) is a
Taipei-listed company (TPEX:7850)
focused on advanced
therapeutics for companion
animals
With a team of 46 employees, PAH
collaborates with global pharma
partners and academic institutions
Operates the largest pet
diagnostic network in its market
with sales coverage across 250 pet
pharmacies and 900+ veterinary
clinics
ORPHAN DRUG DESIGNATION
6
ANOGENITAL CANCER TRIAL UPDATE
▪ U.S. FDA grants Orphan Drug Designation
(ODD) to INV043 (Invion’s lead cancer
drug candidate) for anal cancer
▪ ODD benefits include:
✓ Seven-year exclusive marketing
rights in the US post drug approval
✓ Various financial incentives, such as
potential tax credits for clinical trials,
fee waivers, etc.
✓ Potentially faster path to market
compared to non-orphan drugs with
fast tracked approvals and
shorter/smaller trials
▪ INV043 shows pre-clinical efficacy,
achieving ~80% tumour control in
mice when used in combination
with immune checkpoint inhibitors
▪ Invion and Peter Mac are working
on the trial design and other
preparations for the anogenital
cancer clinical trial
▪ The trial is expected to be
relatively low cost as a “window
of opportunity” trial
Moving Towards Human Trials
Orphan Drug Designation
Combi therapy:
~65% improvement
in effectiveness vs.
ICI alone
IMPROVING IMMUNOTHERAPY OUTCOMES, PARTNERSHIP POTENTIAL
7
COMBINATION WITH IMMUNE CHECKPOINT INHIBITORS (ICI)
• Immune checkpoint inhibitors (ICI), a type of immunotherapy, is standard of care in treatment of several cancers
• Despite widespread use of ICIs, the patient response rate can be as low as 12.5%1
• Independent in vivo studies showed combined INV043 and anti-PD-1 therapies achieved 80% tumour elimination
1 https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2762389
2 https://announcements.asx.com.au/asxpdf/20220530/pdf/459ffkjbvdpjrg.pdf
3 https://investors.inviongroup.com/announcements/6228975
HUDSON INSTITUTE:. ~65% IMPROVEMENT IN TUMOUR VOLUME
(TRIPLE NEGATIVE BREAST CANCER, INTRATUMORAL)2
PETER MAC: ~80% RESPONSE RATE
(ANAL SCC CANCER, TOPICAL)3
*** INV043+PD1 vs Vehicle = p=0.001
** INV043+PD1 vs PD1 p=0.0037
* INV043 vs Vehicle p=0.0397
***
**
*
7/10, no measurable tumour.
8th mouse histology, no
evidence of tumour cells
SAFETY REVIEW COMMITTEE FINDINGS – INITIAL PATIENT GROUP
8
PHASE I/II NON-MELANOMA SKIN CANCER TRIAL
▪ No adverse events identified related to the treatment
▪ Clinician feedback indicated patients did not
experience any pain during the treatment, comparing
favourably to currently approved PDT treatments
▪ Early indications show an observable reduction in the
NMSC lesion size after a single treatment cycle
▪ Highlights INV043’s potential as a diagnostic with
suspected cancers fluorescing under violet light
Change in size of NMSC lesions
treated and untreated lesions*
SEM = Standard Error of the Mean
*Data integrity check (data lock) by the clinical trial manager has not
been completed for the full data set. Further analysis will be
conducted at the next stage of the trial.
Untreated Lesions
Treated Lesions
Findings from Safety Review Committee (SRC)
(initial patient group of 6)
▪ Proceeding to Part 2 of the adaptive trial that will enable
further dose optimisation permitted under the protocol
▪ The safety data is also an important input into the
upcoming Ph I/II anogenital trial done in partnership with
the Peter MacCallum Cancer Centre
Next Steps
POTENTIAL TO DISPLACE STANDARD OF CARE
EVALUATION OF NMSC THERAPIES1
1 Based on management views
* https://www.aad.org/news/guidelines-to-treat-nonmelanoma-skin-cancer
* https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5746716/
* https://amp.cancer.org/cancer/types/melanoma-skin-cancer/about/key-statistics.html
2 https://amp.cancer.org/cancer/types/melanoma-skin-cancer/about/key-statistics.html
INV043
(Topical)
Metvix#/ALA
PDT Treatment
COSMETIC
RESULT
More Pain/
Discomfort)
FAIR GOOD
EFFECTIVENESS
GOOD
Excisional
Surgery
Curettage &
Electrodesiccation
Mohs
Surgery
Cryosurgery
POOR
Less Pain/
Discomfort
9
Non-Melanoma Skin Cancer (NMSC) Phase I/II Clinical Trial (Adaptive Trial Structure):
Addressing the unmet need for one of the world’s most common cancers2
#by Galderma S.A.
DIAGNOSTIC POTENTIAL
10
INV043 FLUORESCES CANCERS UNDER VIOLET LIGHT
Photos from three different patients in the NMSC trial
INV043 appears to localise in the lesion site, which is consistent with preclinical
data that showed accumulation in the tumour cells.
Natural light, no INV043 Violet light, no INV043 Violet light, INV043
Patient 101-002 from Ph I/II NMSC Trial: Day 1 of the treatment
Potential for INV043 to assist surgeons to more accurately remove cancers
• Primary pancreatic (Human PANC1) cancer
• Cancers received INV043 at 0.1 mg/kg by IT (primary
tumours) or IP (metastatic tumours) injection
• After 1 hour, INV043 visualised as fluorescence
localised to tumour mass and margins when
illuminated using violet light
Animal studies at Hudson Institute
• INV043 was seen concentrated within metastatic
nodules 16 hours after IP injection
• Small metastatic nodules on the liver visible to naked
eye when illuminated using violet light
• Triple Negative Breast Cancer (TNBC) is a hard-to-treat
cancer resistant to most chemotherapies
• Hudson Institute proof-of-concept (PoC) pilot showed
complete regression of TNBC in vivo following INV043
treatment
• Tumour mass undetectable two weeks after initial
treatment and no scarring evident
• No recurrence of disease, re-challenge with TNBC
implant could not re-establish new tumours, suggesting
development of protective immunity
PROTECTIVE IMMUNITY
https://inviongroup.com/videos-reports/
Control
Treated
11
MULTIPLE CANCERS, PRECISION CANCER TARGETING, PROTECTIVE IMMUNITY
THERAGNOSTIC POTENTIAL
1 Adapted from https://www.nature.com/articles/s41598-023-30256-0#citeas, using chlorin e6 photosensitizer.
The research activities involving the use of animals were carried out in accordance with relevant guidelines and regulations as well as with
appropriate Animal Ethics Committee approval.
SELECTIVE TARGETING
• INV043 selectively retained in malignant but not healthy
tissue, across multiple cancers (incl. pancreatic, triple-
negative breast, T-cell lymphoma in vivo)
• Minimises collateral damage to healthy organ tissues
with no notable toxicity issues
• INV043 has both fluorescence as well as ablation
characteristics (under different wavelengths of light)
• Applications in both diagnostic (405nm) and
therapeutic use (660nm) – theragnostic potential
1 Cancer is the key area of focus for Invion
2 The Phase I/II NMSC trial uses an adaptive study design means recruitment numbers and timelines may change to accelerate the evaluation of INV043
3 Timing subject to ongoing dialog with US FDA to determine pre-clinical requirements
CANCER1
Prostate Cancer (Funded by RMWC)
Non-Melanoma Skin Cancers (Topical)2
Anogenital Cancers (Topical)
Glioblastoma & Oesophageal
(Funded by Hanlim)
Companion Animal Cancer Studies
(Funded by Protect)
INFECTIOUS DISEASES
HPV (Funded by Dr.inB)
Oral Microbial (Peri-Implant Mucositis)3
MULTIPLE CLINICAL TRIALS AND INDICATIONS
TARGET INDICATIONS AND TIMEFRAMES
DISEASE AREA (CALENDAR YEAR) 1H2024 2H2024 1H2025 2H2025 >CY26
PreClinical Phase 1 Phase 1b/2
12
Follow up and monitoring
Adaptive study design
Completed
NEED FOR MORE AFFORDABLE NEW TREATMENTS
CREATING IMPACT FOR TREATING CANCERS GLOBALLY
13
Cost of new FDA drugs in
2023 jumped 35% YoY at
median price of US$300K1,
making affordability even
harder for the majority of
the world’s patients.
Trends towards personalised
medicines and targeted
therapies (e.g. CAR T / cell
therapies, immunotherapies,
antibody drug conjugates
which can cost US$100-500k2),
Half of new drugs are orphan3,
which cost 5.5 times more than
non-orphan4
Works across multiple cancers without need
to personalise – precision with less complexity
INV043 is a small molecule based therapy
that is highly scalable
Photosoft solution has lower development
and manufacturing costs
Equipment and treatment process is not
complex - helps reach a larger patient base
Commercial Rationale for Photosoft
1 https://www.reuters.com/business/healthcare-pharmaceuticals/prices-new-us-drugs-rose-35-2023-more-than-previous-year-2024-02-23/
2 https://www.mdpi.com/1999-4923/15/6/1761#:~:text=Additionally%2C%20the%20cost%20of%20ADC,a%20barrier%20for%20some%20patients
3 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10290406/#:~:text=There%20has%20been%20significant%20policy,being%20approved%20in%20recent%20years
4 https://www.mdpi.com/1999-4923/15/6/1761#:~:text=Additionally%2C%20the%20cost%20of%20ADC,a%20barrier%20for%20some%20patients
14
DR SOUMYA RAI
PROGRAM MANAGER
• Dental surgeon, clinical and business mgmt experience
• Resident, JLN House and Research Centre, SAIL
• Asst Prof. Rungta College Dental Sciences and Research
• MBA HKUST
PROF SEBASTIAN MARCUCCIO
MEDICINAL CHEMISTRY
• Pharma/drug discovery and dev (co-inventor IVX PDT patents)
• Founder / Director Advanced Molecular Technologies
• Previously in Pharmaceutical Chemicals Research, CSIRO
• Adj. Prof. La Trobe University, PhD Organic Chemistry ANU
ALEXANDER BENNETT
TECHNICAL ADVISOR, LIGHT DEVICES
• 35+ years in R&D, manufacturing and commercialisation of
scientific instrumentation incl. ISO certifications
• GM Forensic Light Sources, Rofin Australia.
• Led Medical Light Source trial for PDT in skin cancers Peter
MacCallum Cancer Centre
DR DANIEL GARAMA
SCIENTIFIC ADVISOR
• Heads proteomics & mitochondrial disease team at the Hudson
Institute of Medical Research
• Expert in cancer biology, proteomics & translational research
• Affiliate at Monash & Melbourne universities
• Published in Science, Nature; recipient of global research
awards
DR AMY PRAWIRA
MEDICAL CONSULTANT
• Founder/CEO, Obatica Pty Ltd (engaged to assist with clinical trials)
• 12+ years in clinical oncology and trials
• Investigator with experience in over 90 early phase clinical trials
• Head, Cancer Trials and Research Unit, Prince of Wales Hospital
(Sydney)
PROF THIAN CHEW
EXECUTIVE CHAIRMAN & CEO
• Co-Founder, Chronic Airway Therapeutics
• Advisory Board, Stanford Medicine CARE
• Executive Director, Goldman Sachs
• Director, KPMG Consulting, Senior Manager KPMG
• A/Prof HKUST, V/Prof UCL Global Bus School Health, MBA/MA Wharton
THE RIGHT EXPERTISE FOR SUCCESS
EXPERIENCED TEAM
SCOTT CARPENTER
PROGRAM DIRECTOR
• Director Business Development, Starpharma
• Program Manager, AusBiotecha
• Regulatory Affairs, Bayer CropScience
• MBA Melb Business School, B. Applied Science RMIT
PROF ROBERT RAMSAY
SCIENTIFIC ADVISOR
• 30+ years research in cancer biology &translational medicine
• Senior Scientist, Ex-Co Head Gastrointestinal Program, Peter
MacCallum Cancer Centre
• Ex-President Australian Society for Medical Research (ASMR)
• Hon.Professor, Dept Oncology & Clinical Pathology, Uni. Melb
For more information, go to www.inviongroup.com
Investor and Media enquiries:
Thian Chew (Chairman & CEO) Brendon Lau (Investor & Media Relations)
T: +61 3 9692 7222 M: +61 409 341 613
E: investor@inviongroup.com E: brendon.lau@inviongroup.com
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