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INVION LIMITED AGM Information 2022

Nov 16, 2022

65148_rns_2022-11-16_9266f063-729e-4a10-b128-749c81b5dcee.pdf

AGM Information

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ANNUAL GENERAL MEETING November 2022

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CEO AGM PRESENTATION Laying the groundwork for an exciting 2023

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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.

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KEY ACHIEVEMENTS

HIGHLIGHTS OVER THE PAST YEAR

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Agreement with IDT for Cancer Research Partners: Cancer GMP manufacture ahead of clinical trials (Nov) Effective against International Anal Cancer SCC patent extends IP in vitro protection for (Sep) INV043 Significantly Photosoft[TM ] improves (Jun) Checkpoint Inhibitor Therapy (May)

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2022
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Infectious Diseases Research Partners: Activity against Zika virus (Sep) Australian Centre for Activity against SARSAntimicrobial Resistance Ecology CoV-2 (Omicron & Delta) (ACARE) & Dengue (Oct) Activity against Infectious Diseases bacterial Superbugs & fungi (Oct)

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LEAD CANCER DRUG CANDIDATE INV043 PATHWAY TO PARTICIPATE IN A US$271B MARKET OPPORTUNITY[1]

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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 Stimulate the body’s natural immune response
prepare to commence
Phase I clinical trials in
2023
Work additively with blockbuster ICI [2] drugs
Be non-toxic, safe and have limited side effects
Support the translation into successful clinical trials [3]
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  • 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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IMPROVED API: INV043 KEY CHARACTERISTICS*

Active against multiple cancers

  • INV043 successfully regressed established T-cell lymphoma, triple negative breast and pancreatic cancers in vivo (n=4-8/group).

  • Formulations enable multiple routes of administration.

  • Treatment activates an immune response.

Strong therapeutic profile

  • No toxicity identified up to 100x the therapeutic dose

  • Selectively retained into tumours in vivo :

  • Within hours accumulates in tumour mass

  • Within a day INV043 is not detectible in healthy tissue

  • Remains concentrated within tumour mass for >3 days

Highly potent and selective

  • ~600x greater photoxicity than Talaporfin sodium (a widely used photosensitiser).

  • No observed off target toxicity.

  • No “dark” toxicity” until 20 to 300 times the therapeutic dose.

Theragnostic potential

  • Two distinct light activations wavelengths

  • Diagnostic : Fluorescence providing highly visible definition of tumour mass and margins.

  • Therapeutic : Activation of INV043 causes rapid cancer cell death and tumour regression.

INV043 activity against multiple cancer cell types

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INV043 fluorescing in a tumour under light

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*Studies carried out by Hudson Institute

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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

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Immune competent
mice with TNBC
(n=3/group)
Day 0 Day 6 Day 15 Day 17 Day 19 Day 21 Day 35
Orthotopic Orthotopic
implantation of reimplantation
4T1 TNBC cells of 4T1 TNBC cells
No adverse Tumour
TREATMENT Tumour mass No tumour
effects regression
GROUP undetectable detectable
observed observed
1. No treatment • Enlarged rapidly and reached endpoint (Tumour size >100mm [2] )
CONTROL
2. INV043 alone (no light)
GROUP 3. Light alone (no INV043) • Obvious metastatic involvement of lungs and abdominal fat
pad at autopsy
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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

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Pre-
treatment Endpoint Tumour volume
Control
Treated
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https://inviongroup.com/videos-reports/
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Figure 4. PDT using INV043 results in complete regression of established tumours.

Mice with established 4T1 breast tumours treated with INV043 PDT at days 6 and 13 post-implant. Tumour size monitored until endpoint (>100mm[2] ). Treatment regressed established tumours to an undetectable level within 14 days of treatment. No tumour regrowth observed. n=3/group; mean +/- SD

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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

*Studies carried out by Peter Mac

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PROOF OF CONCEPT: IMMUNE CHECKPOINT INHIBITORS (ICI) COMBINATION THERAPY FOR PARTICIPATION IN THIS US$140B MARKET[1] (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

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Combi therapy:
>60% increase in
effectiveness vs. ICI
alone
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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 >100mm[2] ).

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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  • 1 https://www.alliedmarketresearch.com/immune-check-pointinhibitors-market

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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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Infectious Diseases Exploring the potential applications of Photosoft[TM]

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BROAD-SPECTRUM ANTI-MICROBIAL POTENTIAL

INFECTIOUS DISEASES: EFFECTIVE AGAINST VIRUSES, BACTERIA AND FUNGI IN VITRO

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“Antimicrobial resistance (AMR) is one of the top 10 threats facing humanity”

World Health Organisation[1]

Leading Institutions : Viroclinics conducted virus tests & ACARE (University of Adelaide) conducted bacteria and fungi tests

Broad Spectrum Potential : In vitro tests showed Photosoft[TM] to be effective against several types of pathogens, including antibiotic-resistant superbugs

Need for New Treatment Options : Potential for Photosoft[TM] as a new treatment class for polymicrobial infections and/or where pathogens cannot develop drug resistance

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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

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1 https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance

EFFECTIVE AGAINST SARS-CoV-2 IN VITRO ANTIVIRAL ACTIVITY AGAINST DELTA AND OMICRON VARIANTS

SARS-CoV-2: Delta

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Selected Photosoft [TM] Compounds vs. Remdesivir
Nine out of ten Photosoft [TM] compounds tested 100
displayed antiviral activity against both Delta 80
and Omicron variants of SARS-CoV-2 60
40
Multiple Photosoft [TM] compounds show
effectiveness against SAR-CoV-2 at far lower 20
concentrations than Remdesivir 0
0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1
Concentration µM
Antiviral activity occurred once Photosoft [TM]
SARS-CoV-2: Omicron
compounds were activated with red light
Selected Photosoft [TM] Compounds vs. Remdesivir
100
Photosoft [TM] compounds tested demonstrated 80
either no or low cytotoxicity 60
40
The global coronavirus treatment market is 20
forecast to reach US$49bn by 2027 (17.5% 0
CAGR) 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1
Concentration µM
% Inhibition - Compound 7 % Inhibition - Remdesivir
https://www.coherentmarketinsights.com/market-insight/coronavirus-treatment-drugs-market-4312
% Inhibition - Compound 9 % Inhibition - Compound 10
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% Inhibition
% Inhibition
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EFFECTIVE AGAINST ZIKA AND DENGUE IN VITRO ANTIVIRAL ACTIVITY AGAINST ZIKA AND DENGUE

Zika

Dengue

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Inhibition: Photosoft [TM] compound vs Monensin [1] Inhibition: Selected Photosoft [TM] Compounds vs Monensin [1]
100 100
90 90
80 80
70 70
60 60
50 50
40 40
30 30
20 - Photosoft [TM] compound - Photosoft [TM] compound 20
10 10
0 0
0 0.2 0.4 0.6 0.8 1 1.2 1.4 0 0.2 0.4 0.6 0.8 1
Concentraton (µM) Concentration (µM)
% Inhibition % Cytotoxicity 1 Monensin is an antibiotic known to have activity against Zika in
in vitro laboratory tests and was a control (benchmark) in these
% Inhibition - Monensin % Cytotoxicity - Monensin studies, but due to its in vivo toxicity cannot be used in humans
% Inhibition
Percentage (%) inhibition
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Several Photosoft[TM] compounds had >100x the activity of Monensin[3] (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

Market is ~US$17 billion in 2022[1] with no vaccines or treatments currently available[2]

Dengue causes intense pain in joints and muscles, hence its nickname “breakbone fever” Treatment market is forecast to hit US$1.3 billion by 2030[4]

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/

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EFFECTIVE AGAINST BACTERIA AND FUNGI MRSA SUPERBUG, E.COLI BACTERIA & CANDIDA ALBICANS FUNGUS

  • Several Photosoft[TM] compounds showed activity in vitro against multiple strains of antibiotic-resistant MRSA bacteria, Escherichia coli bacteria and Candida albicans fungus*

  • 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

  • Photosoft[TM] ’s mode of action has the potential to make it unlikely for superbugs to develop resistance

  • *Tests undertaken at the Australian Centre for Antimicrobial Resistance Ecology (ACARE), University of Adelaide

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Broad Spectrum Activity: Minimum Inhibition
Concentration (MIC50) of Selected Photosoft Compound
following exposure to light for 5 minutes
30
25
20
15
10
5
0
µM
E. coli E. coli ATCC VDL-
Gram-positive (USA300) [MRSA] MIC Gram-positive (ATCC 43300) [MRSA] MIC Gram-negative ( ATCC 25922) MIC Gram-negative ( ATCC 35218) MIC Candida albicans 90028 MIC Candida albicans F1642 MIC
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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.

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THE WAY FORWARD MULTIPLE CATALYSTS AND MILESTONES

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Australia

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  • 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 TBC[1]

Expand Internationally: Leveraging Australian clinical trial data into later stage programs in other major markets

  • GMP manufacturing and scale up : Building capacity to scale up for global late-stage trials and commercialisation

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Early stage broad Atherosclerosis and Proof of Concept based discovery Infectious Diseases on targeted Identification of (AID) indications target indications

1 RMW Cho Group (“RMW”) 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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MANAGEMENT TEAM THE RIGHT EXPERTISE FOR SUCCESS

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THIAN CHEW

EXECUTIVE CHAIRMAN & CEO

  • Managing Partner, Polar Ventures

  • Executive Director, Goldman Sachs

  • Director, KPMG Consulting, Senior Manager KPMG

  • Adj. Prof. HKUST, MBA/MA Wharton School

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DR ANDREW STEPHENS HUDSON INSTITUTE, R&D

  • 15+ years in novel treatment R&D

  • Founder, Ovarian Cancer Biomarker Group, Hudson Institute

  • Postdoc. positions, the Uni. of Sydney and Prince Henry’s Institute, PhD Biochemistry Monash Uni

  • Published extensively, holds several patents

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DR SEBASTIAN MARCUCCIO CHEMISTRY

  • 15+ years in Pharmaceutical and organic chemistry developmental research

  • 16+ years commercial experience in molecular based companies (Managing Director / Founder)

  • Adj. Prof. La Trobe University, PhD Organic Chemistry ANU

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ALEXANDER BENNETT TECHNICAL ADVISOR, LIGHT

  • 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

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MELANIE LEYDIN CFO

  • 25+ years in accounting profession

  • Partner, Vistra

  • CFO and Co. Secretary multiple biotech companies

  • Fellow Gov. Institute of Australia, Chartered Acc’t

NICOLETTA MUNER REGULATORY AND CLINICAL DEVELOPMENT

  • 20+ years non-clinical and clinical drug development, quality, manufacturing, incl. EMA and US FDA approval

  • Founder Canary Regulatory Affairs

  • Global Regulatory Affairs, Clinuvel Pharmaceuticals

  • Pre-clinical and regulatory affairs, Pfizer

LOUISE WHITE

MANUFACTURING AND QUALITY

  • 35+ years in the pharmaceutical industry, 13 years in vaccine manufacturing, CSL, Partner SeerPharma

  • Senior roles in virology R&D, bacterial vaccines production, quality control and production planning

  • Registered auditor for APVMA

KIM STEEL

CLINICAL TRIAL MANAGEMENT

  • 15+ years managing global and clinical drug and device studies from Phase 1-IV across 14 countries

  • Director, Sapro Consulting

  • Project Director, Novotech

  • Project Manager, Pacific Clinical Research Group

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SUMMARY

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Infectious Diseases – Early Findings : In vitro effectiveness against multiple viruses & bacteria including SARS-CoV2 (Delta and Omicron) and MRSA

Cancer - Promising Results : Total tumour regression, immune response, potential ICI combination therapies

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Well Funded : Cancer program fully funded & AID partially funded by RMWC

Cancer - Clinical Trials : Human trials across several cancer types expected to commence 2023

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Experienced Management, WorldLeading Partnerships : Balance of expertise in life sciences and commercialisation combined with world-renowned partnerships

Multiple Growth Options : Large addressable markets, multiple indications, partnership opportunities

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