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ANNUAL GENERAL
MEETING
November 2022
CEO AGM PRESENTATION
Laying the groundwork for an exciting 2023
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
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expressly disclaimed. Any opinions expressed reflect the Company’s
position at the date of this presentation and are subject to change.
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Next Generation Photodynamic Therapy | November 2022
KEY ACHIEVEMENTS
HIGHLIGHTS OVER THE PAST YEAR
Cancer
International
patent extends IP
protection for
PhotosoftTM
INV043 Significantly
(Jun)
improves
Checkpoint Inhibitor
Therapy (May)
Agreement with IDT for
GMP manufacture
ahead of clinical trials
(Nov)
Effective against
Anal Cancer SCC
in vitro
(Sep)
Cancer Research Partners:
2022
Activity against
Zika virus
(Sep)
Infectious Diseases
Infectious Diseases Research Partners:
Activity against SARSCoV-2 (Omicron & Delta)
& Dengue
(Oct)
Activity against
bacterial Superbugs
& fungi
(Oct)
Australian Centre for
Antimicrobial Resistance Ecology
(ACARE)
LEAD CANCER DRUG CANDIDATE INV043
PATHWAY TO PARTICIPATE IN A US$271B MARKET OPPORTUNITY1
Proof-of-Concept studies of lead candidate INV043 has been shown to:
Selectively absorbed by cancer cells and not healthy tissue
Effective in regressing multiple types of cancer in vivo
Cancer is the primary
focus of Invion as we
prepare to commence
Phase I clinical trials in
2023
Stimulate the body’s natural immune response
Work additively with blockbuster ICI2 drugs
Be non-toxic, safe and have limited side effects
Support the translation into successful clinical trials3
1 Oncology market exceeded US$270.5 billon in 2021 and is forecast to grow at 10.2% CAGR between 2022 and 2028, according to GMI
2 Immune Checkpoint Inhibitor (ICI) therapies are part of the Immunotherapy market
3 Scheduled for 2H CY2022 or 1H CY2023
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Next Generation Photodynamic Therapy | November 2022
IMPROVED API: INV043
KEY CHARACTERISTICS*
Active against multiple cancers
Highly potent and selective
• INV043 successfully regressed
established T-cell lymphoma,
triple negative breast and
pancreatic cancers in vivo
(n=4-8/group).
• ~600x greater photoxicity
than Talaporfin sodium (a
widely used photosensitiser).
• Formulations enable multiple
routes of administration.
• No “dark” toxicity” until 20 to
300 times the therapeutic
dose.
• Treatment activates an
immune response.
• No observed off target
toxicity.
Strong therapeutic profile
Theragnostic potential
• No toxicity identified up to
100x the therapeutic dose
• Selectively retained into
tumours in vivo:
Two distinct light activations
wavelengths
o Within hours accumulates in
tumour mass
o Within a day INV043 is not
detectible in healthy tissue
o Remains concentrated
within tumour mass for >3
days
INV043 activity against multiple cancer cell types
INV043 fluorescing in a tumour under light
• Diagnostic: Fluorescence
providing highly visible
definition of tumour mass
and margins.
• Therapeutic: Activation of
INV043 causes rapid
cancer cell death and
tumour regression.
*Studies carried out by Hudson Institute
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Next Generation Photodynamic Therapy | November 2022
PROOF OF CONCEPT: PRIMARY TUMOUR PILOT STUDY
REGRESSION AND PROTECTIVE IMMUNITY
Treatment with established tumours (INV043 with light)
•
INV043 was injected intratumorally (0.1mg/kg)
•
16 hours later, illuminated with red light
•
No anaesthesia required, no adverse effects observed
Immune competent
mice with TNBC
(n=3/group)
Day 0
Day 6
Day 15
Orthotopic
implantation of
4T1 TNBC cells
TREATMENT
GROUP
CONTROL
GROUP
7
Day 35
Day 17 Day 19 Day 21
Orthotopic
reimplantation
of 4T1 TNBC cells
No adverse
effects
observed
1. No treatment
2. INV043 alone (no light)
3. Light alone (no INV043)
Tumour
regression
observed
Tumour mass
undetectable
No tumour
detectable
• Enlarged rapidly and reached endpoint (Tumour size >100mm2)
• Obvious metastatic involvement of lungs and abdominal fat
pad at autopsy
Next Generation Photodynamic Therapy | November 2022
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.
PROOF OF CONCEPT: PRIMARY TUMOUR PILOT STUDY
REGRESSION AND PROTECTIVE IMMUNITY
•
Triple Negative Breast Cancer (TNBC) is a hard-to-treat cancer resistant to most chemotherapies
•
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
•
Additional PoC tests being carried out by Hudson Institute
Endpoint
Tumour volume
Control
Pretreatment
Treated
Mice with established 4T1
breast tumours treated with
INV043 PDT at days 6 and 13
post-implant. Tumour size
monitored until endpoint
(>100mm2). Treatment
regressed established tumours
to an undetectable level
within 14 days of treatment.
No tumour regrowth observed.
n=3/group; mean +/- SD
https://inviongroup.com/videos-reports/
8
Figure 4. PDT using INV043
results in complete
regression of established
tumours.
Next Generation Photodynamic Therapy | November 2022
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.
ANAL CANCER SCC
PROMISING RESULTS AGAINST NEW CANCER CLASS*
Cytotoxicity data of human anal SCC cells lines
In vitro study showed INV043’s effectiveness against six
squamous cell carcinoma (SCC) cell lines that
represent the full range of anal cancers
Most anal cancers are SCCs and are difficult to treat
with the global market estimated to be worth US$1.3bn
by 2028 (6.3% CAGR)1
Findings were consistent with the results of work done
at the Hudson Institute on other cancer types
Preclinical testing using topical delivery of INV043
started as a prelude to moving to clinical human
testing of anal SCC
1Source:https://www.coherentmarketinsights.com/
market-insight/anal-cancer-market-4701
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Next Generation Photodynamic Therapy | November 2022
*Studies carried out by Peter Mac
PROOF OF CONCEPT: IMMUNE CHECKPOINT INHIBITORS (ICI)
COMBINATION THERAPY FOR PARTICIPATION IN THIS US$140B MARKET1 (BY 2030)
•
Immune checkpoint inhibitors are widely used for the treatment of lung cancer and melanoma. However, ICI
treatments are typically only effective on a small proportion of patients
•
Proof of Concept (PoC) pilot by Hudson Institute showed both INV043 (under restricted administration) and
anti-PD-1 therapies achieved a very similar level of tumour growth restriction following therapy, with tumour
growth reduced by ~40% compared to controls
•
A combination of INV043 with anti PD-1 provided substantially enhanced restriction (~65%) of tumour growth,
with clear tumour regression despite the sub-optimal INV043 treatment protocol used
Figure 5. INV043-PDT combines with immune checkpoint
inhibition to regress tumour mass.
Mice with established 4T1 breast tumours were treated using a
restricted INV043 PDT protocol and / or anti PD-1 antibody over
a period of 14 days. Tumour size was monitored until endpoint
(tumour size >100mm2).
Combi therapy:
>60% increase in
effectiveness vs. ICI
alone
Monotherapies restricted tumour growth compared to
untreated controls; combination therapy regressed and
stabilized tumours and achieved a ~65% reduction in tumour
size at endpoint. INV043 control, no light activation; IgG2a
control, isotype antibody control; combination, PDT+ anti PD-1.
Additional control groups have been omitted for clarity. mean
+/- SD, n=4/group.
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.
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Next Generation Photodynamic Therapy | November 2022
1 https://www.alliedmarketresearch.com/immune-check-point-
inhibitors-market
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.
Infectious Diseases
Exploring the potential applications of
PhotosoftTM
BROAD-SPECTRUM ANTI-MICROBIAL POTENTIAL
INFECTIOUS DISEASES: EFFECTIVE AGAINST VIRUSES, BACTERIA AND FUNGI IN VITRO
“Antimicrobial resistance (AMR) is one of the top 10 threats facing humanity”
World Health Organisation1
Leading Institutions: Viroclinics conducted virus
tests & ACARE (University of Adelaide) conducted
bacteria and fungi tests
Broad Spectrum Potential: In vitro tests showed
PhotosoftTM to be effective against several types of
pathogens, including antibiotic-resistant superbugs
Need for New Treatment Options: Potential for
PhotosoftTM as a new treatment class for
polymicrobial infections and/or where pathogens
cannot develop drug resistance
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Next Generation Photodynamic Therapy | November 2022
1 https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance
“
Given the general mode
of action of PDT, we
surmise that it is unlikely for
superbugs to develop
resistance to the
compounds.
”
Prof Darren J. Trott, Director, Australian
Centre for Antimicrobial Resistance
Ecology (ACARE), University of
Adelaide
EFFECTIVE AGAINST SARS-CoV-2 IN VITRO
ANTIVIRAL ACTIVITY AGAINST DELTA AND OMICRON VARIANTS
SARS-CoV-2: Delta
Selected PhotosoftTM Compounds vs. Remdesivir
Multiple PhotosoftTM compounds show
effectiveness against SAR-CoV-2 at far lower
concentrations than Remdesivir
100
80
% Inhibition
Nine out of ten PhotosoftTM compounds tested
displayed antiviral activity against both Delta
and Omicron variants of SARS-CoV-2
60
40
20
0
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
0.9
1
Concentration µM
Antiviral activity occurred once PhotosoftTM
compounds were activated with red light
SARS-CoV-2: Omicron
Selected PhotosoftTM Compounds vs. Remdesivir
either no or low cytotoxicity
The global coronavirus treatment market is
forecast to reach US$49bn by 2027 (17.5%
CAGR)*
100
% Inhibition
PhotosoftTM compounds tested demonstrated
80
60
40
20
0
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
Concentration µM
*https://www.coherentmarketinsights.com/market-insight/coronavirus-treatment-drugs-market-4312
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Next Generation Photodynamic Therapy | November 2022
% Inhibition - Compound 7
% Inhibition - Remdesivir
% Inhibition - Compound 9
% Inhibition - Compound 10
EFFECTIVE AGAINST ZIKA AND DENGUE IN VITRO
ANTIVIRAL ACTIVITY AGAINST ZIKA AND DENGUE
Zika
Dengue
Inhibition: PhotosoftTM compound vs Monensin1
Inhibition: Selected PhotosoftTM Compounds vs Monensin1
100
90
90
80
80
70
70
% Inhibition
Percentage (%) inhibition
100
60
50
40
30
20
- PhotosoftTM compound
- PhotosoftTM compound
60
50
40
30
20
10
10
0
0
0
0.2
0.4
0.6
0.8
1
1.2
0
1.4
% Cytotoxicity
% Inhibition - Monensin
% Cytotoxicity - Monensin
0.4
0.6
0.8
1
Concentration (µM)
Concentraton (µM)
% Inhibition
0.2
1 Monensin is an antibiotic known to have activity against Zika in
in vitro laboratory tests and was a control (benchmark) in these
studies, but due to its in vivo toxicity cannot be used in humans
Several PhotosoftTM compounds had >100x the
activity of Monensin3 (selected control) in vitro
One compound had an EC50 (half max effective
concentration) >90 times lower than Monensin
Zika virus is found in 86 countries and is linked to
birth defects and other neurological complications
Dengue causes intense pain in joints and
muscles, hence its nickname “breakbone fever”
Market is ~US$17 billion in 20221 with no vaccines or
treatments currently available2
Treatment market is forecast to hit US$1.3 billion
by 20304
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Next Generation Photodynamic Therapy | November 2022
2https://www.marketdataforecast.com/market-reports/zika-virus-vaccines-market
3https://www.who.int/news-room/fact-sheets/detail/zika-virus
4 https://www.biospace.com/article/-dengue-vaccines-market-size-to-reach-us-1-3-billion-by-2030/
EFFECTIVE AGAINST BACTERIA AND FUNGI
MRSA SUPERBUG, E.COLI BACTERIA & CANDIDA ALBICANS FUNGUS
activity in vitro against multiple strains of
antibiotic-resistant MRSA bacteria,
Escherichia coli bacteria and Candida
albicans fungus*
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Next Generation Photodynamic Therapy | November 2022
10
5
Candida albicans VDLF1642 MIC
Candida albicans ATCC
90028 MIC
0
Gram-negative (E. coli
ATCC 35218) MIC
*Tests undertaken at the Australian Centre for
Antimicrobial Resistance Ecology (ACARE),
University of Adelaide
15
Gram-negative (E. coli
ATCC 25922) MIC
PhotosoftTM’s mode of action has the
potential to make it unlikely for
superbugs to develop resistance
20
Gram-positive (USA300)
[MRSA] MIC
MRSA is an antibiotic resistant bacteria
that is difficult to treat, with the World
Health Organisation (WHO) having
declared antimicrobial resistance (AMR)
as one of the top 10 threats facing
humanity
25
µM
30
Broad Spectrum Activity: Minimum Inhibition
Concentration (MIC50) of Selected Photosoft Compound
following exposure to light for 5 minutes
Gram-positive (ATCC
43300) [MRSA] MIC
Several PhotosoftTM compounds showed
Note: The in vitro studies that were conducted at the University of Adelaide used
enrofloxacin and amphotericin B as control antibiotics for the antibacterial and antifungal
tests, respectively.
THE WAY FORWARD
MULTIPLE CATALYSTS AND MILESTONES
Australia
Proof of Concept (PoC) Building on in vivo work further
demonstrating both safety and efficacy profiles
•
Pre-clinical Preparations: Building foundations for clinical
trials in multiple indications and internationally
•
Clinical Trials: With strong in vitro and in vivo results
demonstrating both safety and efficacy profiles, and across
multiple cancer types, the next steps will be to conduct
clinical trials in multiple indications, including
•
•
Skin Cancer (superficial basal cell carcinoma)
•
Anogenital Cancer
•
Other solid tumour cancers TBC1
GMP manufacturing and scale up: Building capacity to
scale up for global late-stage trials and commercialisation
AID
Atherosclerosis and
Infectious Diseases
(AID)
Early stage broad
based discovery
Identification of
target indications
1 RMW Cho Group (“RMW”)
Global
Cancer
•
Expand
Internationally:
Leveraging
Australian clinical
trial data into later
stage programs in
other major
markets
Proof of Concept
on targeted
indications
as licensor of PhotosoftTM technology, is pursuing independent research in parallel with Invion’s R&D efforts
including a prostate cancer trial. The research is complementary/supplemental to Invion’s development program. To the extent that
Invion becomes aware of material information relating to RMW’s studies, Invion will release the information to the ASX in compliance with
its disclosure obligations (noting however that Invion is not involved in RMW’s studies and does not have direct access to information)
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Next Generation Photodynamic Therapy | November 2022
MANAGEMENT TEAM
THE RIGHT EXPERTISE FOR SUCCESS
THIAN CHEW
EXECUTIVE CHAIRMAN & CEO
MELANIE LEYDIN
CFO
• Managing Partner, Polar Ventures
• Executive Director, Goldman Sachs
• Director, KPMG Consulting, Senior Manager KPMG
• Adj. Prof. HKUST, MBA/MA Wharton School
• 25+ years in accounting profession
• Partner, Vistra
• CFO and Co. Secretary multiple biotech companies
• Fellow Gov. Institute of Australia, Chartered Acc’t
DR ANDREW STEPHENS
HUDSON INSTITUTE, R&D
NICOLETTA MUNER
REGULATORY AND CLINICAL DEVELOPMENT
• 15+ years in novel treatment R&D
• 20+ years non-clinical and clinical drug development, quality,
manufacturing, incl. EMA and US FDA approval
• Founder, Ovarian Cancer Biomarker Group, Hudson Institute
17
• Postdoc. positions, the Uni. of Sydney and Prince Henry’s Institute,
PhD Biochemistry Monash Uni
• Founder Canary Regulatory Affairs
• Published extensively, holds several patents
• Pre-clinical and regulatory affairs, Pfizer
DR SEBASTIAN MARCUCCIO
CHEMISTRY
LOUISE WHITE
MANUFACTURING AND QUALITY
• 15+ years in Pharmaceutical and organic chemistry
developmental research
• 35+ years in the pharmaceutical industry, 13 years in vaccine
manufacturing, CSL, Partner SeerPharma
• 16+ years commercial experience in molecular based companies
(Managing Director / Founder)
• Senior roles in virology R&D, bacterial vaccines production,
quality control and production planning
• Adj. Prof. La Trobe University, PhD Organic Chemistry ANU
• Registered auditor for APVMA
ALEXANDER BENNETT
TECHNICAL ADVISOR, LIGHT
KIM STEEL
CLINICAL TRIAL MANAGEMENT
• 35+ years in R&D, manufacturing and commercialisation of
scientific instrumentation incl. ISO certifications
• 15+ years managing global and clinical drug and
device studies from Phase 1-IV across 14 countries
• GM Forensic Light Sources, Rofin Australia.
• Director, Sapro Consulting
• Led Medical Light Source trial for PDT in skin cancers Peter
MacCallum Cancer Centre
• Project Director, Novotech
Next Generation Photodynamic Therapy | November 2022
• Global Regulatory Affairs, Clinuvel Pharmaceuticals
• Project Manager, Pacific Clinical Research Group
SUMMARY
18
Cancer - Promising Results:
Total tumour regression,
immune response, potential ICI
combination therapies
Infectious Diseases – Early Findings:
In vitro effectiveness against multiple
viruses & bacteria including SARS-CoV2 (Delta and Omicron) and MRSA
Cancer - Clinical Trials: Human trials
across several cancer types expected
to commence 2023
Well Funded: Cancer program fully
funded & AID partially funded by
RMWC
Multiple Growth Options: Large
addressable markets, multiple
indications, partnership opportunities
Experienced Management, WorldLeading Partnerships:
Balance of expertise in life sciences
and commercialisation combined with
world-renowned partnerships
Next Generation Photodynamic Therapy | November 2022
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