INVION LIMITED — AGM Information 2024

Nov 13, 2024

ANNUAL GENERAL MEETING

November 2024

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Next Generation Photodynamic Therapy (PDT) for Cancers and Infectious Diseases

ASX: IVX

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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2

YEAR OF ACHIEVEMENTS

PROGRESSING TOWARDS KEY CLINICAL MILESTONES

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Patient Recruitment for Ph I/II Non-Melanoma Skin Cancer Trial Successful Ph 2 Prostate Cancer Clinical Trial Results Collaboration Hanlim Pharm: Glioblastoma (Preclinical) Combination INV043 + ICI Immunotherapy in ASCC: 80% Tumour Control (vs 12% standalone) Partnership Dr.inB to Develop Photosoft for HPV (PoC Clinical Trials) GMP Manufacture INV043 by IDT Australian Patent Granted

FY 24

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FY 25

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3

TARGET DISEASES AND INDICATIONS

PDT FOR TREATMENT OF CANCERS AND INFECTIOUS DISEASES*

PRIMARY FOCUS: CANCER (INV043)

INFECTIOUS DISEASES

• Multiple cancer indications

• Ablation and activation of immune response

• Improved efficacy of immune checkpoint inhibitor (ICI) treatments when in combination

• Topical and systemic formulations

• Broad spectrum antimicrobial activity against viruses, bacteria and fungi

• No known drug resistance (to address AMR)

• Commercially viable focus

• Strong therapeutic profile

Target Indications

• Non-melanoma skin cancer (topical)

• Prostate cancer (sublingual)

• Anogenital cancer (topical)

• Glioblastoma (GBM): studies undertaken and funded by Hanlim

Pharma

Target Indications

  - Human Papilloma Virus (HPV): studies undertaken and **funded by Dr.inB**

  - Oral antimicrobial: peri-implant mucositis

  - Additional TBD

• Solid tumour cancer TBD (IV)

• *Core Australian cancer development fully funded by RMW Cho Group, inventor/owner of Photosoft. Invion has exclusive rights to Photosoft in Asia and Oceania, including Australia and New Zealand (ANZ), but excluding the specified territories of China, Macau and Taiwan. The USA and Canada are included for Infectious Disease Indications. Invion co-contributes 25% pre-clinical & 75% clinical costs outside of ANZ.

4

RESULTS AND FINDINGS: CANCER Clinical & Preclinical Data

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PHASE II PROSTATE CANCER CLINICAL TRIAL

INVESTIGATOR-LED PROSTATE CANCER STUDY USING INV043*

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Screening : Men between 50-80 years with 1 [st] cohort of
 Biopsy proven primary prostate cancer, or
 Primary prostate cancer diagnosed by 25 patients
enrolled
PSMA-PET or MRI.
41 Patients
75 Patients
enrolled 2 [nd] cohort of
originally
(due to COVID- 16 patients
planned
19 disruptions) treated post-
COVID
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COVID-19 Lockdowns : 10 patients dropped out. Remaining treated but with inconsistent compliance and data collection

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Only data
from 2 [nd]
cohort used
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PATIENT PROFILE

PRIMARY ENDPOINT

TREATMENT PROTOCOL

Patient Profile

• • Primary or relapsed Primary or relapsed localised prostate

• localised prostate cancer (diagnosed via

• cancer (diagnosed via biopsy or PSMA-PET)

• biopsy or PSMA-PET)

• • Ages: 50-70 Ages: 50-70 (mean 62.5) (mean 62.5)

• • Gleason Scores: 6-9 • Baseline Gleason (mean 6.9) Scores: 6-9 (mean 6.9)

INV043 PDT treatment effectiveness using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)

SECONDARY ENDPOINTS

To assess safety and tolerability as well as further assessments on effectiveness using standard outcome measures

Each patient had 6 cycles of PDT treatment over 9 weeks (2 x PDT cycles over consecutive days, then four-week interval) Each PDT cycle consisted of 2 steps.

Step 1 : Sublingual administration of photosensitiser

Step 2 : ~15-20 hours after dosing, 25 min of 660 nm laser administered

6 * RMW Cho Group funded study as previously disclosed to the market

PHASE II PROSTATE TRIAL RESULTS: SUBLINGUAL (SYSTEMIC) COMPELLING SAFETY, SOLID EFFICACY SIGNALS

SAFE AND WELL TOLERATED

EFFICACY: 40-44% RESPONSE RATE

When administered sublingually to patients over 6 cycles of PDT treatments (from 2[nd] cohort, n=16) over 3 months :

• No serious adverse events, life-threatening treatment emergent adverse events (TEAEs)

• No clinically significant changes in vital signs, ECGs, or laboratory parameters reported

• All adverse events reported were mild

PSMA-PET[1] Results

Patients (Cohort 2, n-=16) evaluated using PSMA-PET scan to detect prostate cancer:

• BEFORE: All 16 patients were positive before treatment

• AFTER: 7 patients negative 3 months after treatment (~44% response) , 9 patients were positive

In contrast, current treatment options (eg, radiotherapy, chemotherapy and surgery) carry risks of significant side effects such as incontinence, bowel dysfunction, erectile dysfunction and/or infertility # [1]

Recorded Adverse Events

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8
16 patients x 6 questionnaires = 96 recordings
6
During After
4
2
0
7
No. of Occurrences of TEAEs
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RECIST Framework[3 ] (Response Evaluation Criteria)

Where possible, MRI scans taken pre and post treatment to measure lesion size in prostate (n=10)[2]

• 40% patients had +ve response 3 mths post treatment

• 1 complete regression (no detectable lesion)

• 3 partial regression (>30% reduction in lesion size)

• 40% patients showed stable disease

• 20% with disease progression (>30% lesion increase)

1 PSMA PET-CT now routinely used to evaluate prostate cancer for primary staging and suspected tumour recurrence (Combes AD, 2022). Employs radioactive substance that targets PSMA (prostate-specific membrane antigen) protein expressed by prostate cancer cells.

• 2 Two received prostatectomy prior to PDT treatment and were excluded. Four patients did not have MRI scans for various reasons (eg, presence of implants) and excluded from assessment.

3 https://recist.eortc.org

1 https://www.pcf.org/about-prostate-cancer/prostate-cancer-side-effects/

ONGOING PHASE I/II TRIAL: NON-MELANOMA SKIN CANCER THERAGNOSTIC ENDPOINTS

• Adaptive: Open label adaptive trial design (3+3 light dose / dose light interval escalation[1] ) enables flexibility in size and timing, with option for repeat treatment depending on response

• Safety, Dose Optimization and Efficacy : Earlier parts focus more on safety and tolerability, later parts more on dose and schedule optimization, and efficacy. Multiple treatments may be repeated for patients

• Significant Unmet Need : Cutaneous Squamous Cell Carcinoma (cSCC) and superficial Basal Cell Carcinoma (sBCC), 98% of all skin cancers – one of the world’s most common cancers

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Part 3
Dose Expansion
Part 2
Dose Light Interval
Part 1
Optimisation
(Optional)
Light Dose, 3+3
Dose-Escalation
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ENDPOINTS

• Safety and tolerability including Dose Limiting toxicity (DLT)

• Dose optimization : Light dose, dose light interval investigations

• Anti-tumour activity

• Diagnostic via fluorescence

• Pharmacodynamic investigations

Ongoing screening and recruitment in Australia for NMSC trial using topical formulation

1 In a “3+3 design,” three patients are initially enrolled into a given dose cohort. If there is no DLT (dose limiting toxicity) observed in any of these subjects, the trial proceeds to enroll additional subjects into the next higher dose cohort.

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WHY SKIN CANCER?

ATTRACTIVE CLINICAL TRIAL INDICATION

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Relatively Cost Effective

Costs to undertake skin cancer trials typically lower than for other routes of administration (eg, intravenous)

Faster Path to Market

Trials with topical treatments often quicker to complete due to fewer safety concerns and effects can be more readily observed

Synergies with Other Studies

Safety data from same topical formulation may enable a faster path to a Phase II trial for anogenital cancers

Large Attractive Market

One of the world’s most common cancers with the skin cancer treatment market expected to hit US$18.1B in 2030 (7.7% CAGR[1] )

Unmet Medical Need

NMSC comprise 98% of all skin cancers and deaths exceed melanoma globally[2 ] Standard of care can result in scarring and pain

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1 https://finance.yahoo.com/news/skin-cancer-treatment-market-surpass-130500291.html

2 GLOBOCON 2020, WHO

EVALUATION OF NMSC THERAPIES[1]

POTENTIAL TO DISPLACE STANDARD OF CARE

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 cancers[2]

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GOOD
INV043
(Topical)
Metvix [#] /ALA
PDT Treatment
#by Galderma S.A.
COSMETIC
RESULT
Cryosurgery
Mohs
Surgery
Curettage &
Electrodesiccation Less Pain/ More Pain/
Discomfort Discomfort)
Excisional
Surgery
POOR
FAIR EFFECTIVENESS GOOD
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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

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10

TREATMENT OPTIONS: FLEXIBILITY FOR CLINICIANS

MULTIPLE PATHWAYS FOR DRUG AND TARGETED LIGHT DELIVERY

INV043 can be administered to multiple target indications via different drug and light delivery options

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ROUTES OF DRUG ADMINISTRATION LIGHT ADMINISTRATION OPTIONS MULTIPLE
POTENTIAL TARGETS
TOPICAL INTRAVENOUS TOPICALLY (LASER/LED) ENDOSCOPICALLY
INTRATUMORAL SUBLINGUAL WITH OPEN SURGERY KEYHOLE SURGERY
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11

THERAGNOSTIC POTENTIAL MULTIPLE CANCERS, PRECISION CANCER TARGETING, PROTECTIVE IMMUNITY

SELECTIVE TARGETING

PROTECTIVE IMMUNITY

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Control
Treated
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https://inviongroup.com/videos-reports/

• INV043 selectively retained in malignant but not healthy tissue, across multiple cancers (incl. pancreatic, triplenegative 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

• 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

12

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.

COMBINATION WITH IMMUNE CHECKPOINT INHIBITORS (ICI) IMPROVING IMMUNOTHERAPY OUTCOMES, PARTNERSHIP POTENTIAL

• 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

HUDSON INSTITUTE:. ~65% IMPROVEMENT IN TUMOUR VOLUME (TRIPLE NEGATIVE BREAST CANCER, INTRATUMORAL)[2]

PETER MAC: ~80% RESPONSE RATE (ANAL SCC CANCER, TOPICAL)[3]

• 4T1 breast tumours treated using a restricted INV043 PDT protocol (intratumoural) and / or anti PD-1 antibody (intratumoral)

• Anal Squamous Cell Carcinoma (ASCC) tumours treated using a restricted INV043 PDT protocol (topical) and / or anti PD-1 antibody

• Monotherapies restricted tumour growth vs untreated controls

• Monotherapies restricted tumour growth vs untreated controls, with standalone INV043 showing lower tumour volume vs ICI alone

• Combination therapy regressed and stabilized tumours and achieved a ~65% reduction in tumour size at endpoint (n=4/group)

• Combination therapy resulted in 80% tumour-free subjective at endpoint (n=8-10/group)

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7/10, no measurable tumour.
8 [th] mouse histology, no
evidence of tumour cells


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Combi therapy:
~65% improvement
in effectiveness vs.
ICI alone
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• *** INV043+PD1 vs Vehicle = p=0.001

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• ** INV043+PD1 vs PD1 p=0.0037

• INV043 vs Vehicle p=0.0397

• 1 https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2762389

• 2 https://announcements.asx.com.au/asxpdf/20220530/pdf/459ffkjbvdpjrg.pdf

• 3 Per ASX announcement 4 March 2024

13

CREATING IMPACT FOR TREATING CANCERS GLOBALLY

NEED FOR MORE AFFORDABLE NEW TREATMENTS

Cost of new FDA drugs in 2023 jumped 35% YoY at median price of US$300K[1] , 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$100-500k[2] ),

Commercial Rationale for Photosoft

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

Half of new drugs are orphan[3] , which cost 5.5 times more than non-orphan[4]

Equipment and treatment process is not complex - helps reach a larger patient base

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

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14

TARGET INDICATIONS AND TIMEFRAMES

MULTIPLE CLINICAL TRIALS AND INDICATIONS

DISEASE AREA (CALENDAR YEAR) 1H2024 2H2024 1H2025 2H2025 >CY26 CANCER[1] Prostate Cancer (Funded by RMWC) Completed Follow up and monitoring Non-Melanoma Skin Cancers (Topical)[2] Adaptive study design Anogenital Cancers (Topical) Glioblastoma (Funded by Hanlim) INFECTIOUS DISEASES HPV (Funded by Dr.inB) Oral Microbial (Peri-Implant Mucositis)[3] ~~PreClinic~~ al Phase 1 Phase 1b/2

• 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

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15

INFECTIOUS DISEASES Additional Commercialisation Opportunities

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BROAD-SPECTRUM ANTI-MICROBIAL POTENTIAL ANTI-MICROBIAL TREATMENTS – WITHOUT RESISTANCE

“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

SARS-CoV-2: Omicron Selected Photosoft[TM] Compounds vs. Remdesivir

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100
80 Photosoft [TM] compounds
60
40
20 Remdesivir
0
0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1
Concentration µM
% Inhibition
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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

“ Given the general mode of action of PDT… 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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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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1 https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance

TARGET ANTIMICROBIAL INDICATIONS

COST EFFECTIVE AND ACCELERATED PATHS TO CLINICAL TRIALS

HPV PROGRAM FUNDED BY DR.INB

PERIODONTAL DISEASE

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HPV distribution profile in women [1]
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57.7%
44.4%
42.2%
21.4%
3.7%
Eastern Asia Central & Sub-Saharan Eastern Western
Southern Africa Europe Europe
Asia
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Collaboration

• Undertake and fund to Proof-of-Concept clinical trials to test patient safety and efficacy (using different Photosoft[TM] photosensitizer than INV043)

• Dr.inB is a leading developer of PDT treatments in South Korea backed by Hanlim Pharma. Co., Ltd.

• Collaboration provides accelerated pathway to demonstrate clinical potential of Photosoft in infectious diseases like HPV

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Addressing a Growing Unmet Need

• Per CDC, 47.2% in US >30 years, have a form of periodontal disease , increasing 70.1% of those >65 years[2]

• Global periodontal market size US$ 9.1 billion in 2022, to reach ~US$ 24.4 billion by 2032[3]

• 28-56% of implant patients develop peri-implantitis[4] , an inflammatory reaction, with loss of supporting bone around an implant

• Photosoft[TM] PDT advantages

  • No resistance development

  • Non-invasive treatment

• Invion retains all rights to Photosoft and any new IP

• 1 https://www.sciencedirect.com/science/article/abs/pii/S0264410X12010808

• 18 2 https://www.cdc.gov/oralhealth/conditions/periodontal-disease.html 3 https://www.futuremarketinsights.com/reports/periodontalmarket#:~:text=Periodontal%20Market%20Size%20%2D%20Industry%20Outlook,billion%20by%20the%20year%202032 4 https://pubmed.ncbi.nlm.nih.gov/18724856/ and Carl E. Misch 4th Edition

• Ease of application

• Repeated treatment possible

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EXPERIENCED TEAM

THE RIGHT EXPERTISE FOR SUCCESS

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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

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SCOTT CARPENTER PROGRAM DIRECTOR

• Director Business Development, Starpharma

• Program Manager, AusBiotech

• Regulatory Affairs, Bayer CropScience

• MBA Melb Business School, B. Applied Science RMIT

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

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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)

KIM STEEL

CLINICAL TRIAL MANAGEMENT

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

• Managing Director, SAPRO Consulting

• Project Director, Novotech

• Project Manager, Pacific Clinical Research Group

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

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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

• 35+ years in pharmaceutical/organic chemistry drug discovery and development (co-inventor recent PDT patents)

• Founder / Director Advanced Molecular Technologies

• Previously in Pharmaceutical Chemicals Research, CSIRO

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

LOUISE WHITE MANUFACTURING AND QUALITY

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

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

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• Registered auditor for APVMA

19

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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