Announcement PDF Invion Limited ABN 76 094 730 417 Annual Report - 30 June 2025 Invion Limited Appendix 4E Preliminary final report 1. Company details Name of entity: ABN: Reporting period: Previous period: Invion Limited 76 094 730 417 For the year ended 30 June 2025 For the year ended 30 June 2024 2. Results for announcement to the market $ Revenues from ordinary activities down 100.0% to - Loss from ordinary activities after tax attributable to the owners of Invion Limited up 56.5% to (8,807,732) Loss for the year attributable to the owners of Invion Limited up 56.5% to (8,807,732) Dividends There were no dividends paid, recommended or declared during the current financial period. Comments The loss for the consolidated entity after providing for income tax amounted to $8,807,732 (30 June 2024: $5,627,765). 3. Net tangible assets Reporting period Cent Net tangible assets per ordinary security (0.34) 4. Control gained over entities Not applicable. 5. Loss of control over entities Not applicable. 6. Dividends Current period There were no dividends paid, recommended or declared during the current financial period. Previous period There were no dividends paid, recommended or declared during the previous financial period. 7. Dividend reinvestment plans Not applicable. 1 Previous period Cent 0.02 Invion Limited Appendix 4E Preliminary final report 8. Details of associates and joint venture entities Not applicable. 9. Foreign entities Details of origin of accounting standards used in compiling the report: Not applicable. 10. Audit qualification or review Details of audit/review dispute or qualification (if any): The financial statements have been audited and an unmodified opinion with a paragraph on material uncertainty related to going concern has been issued. 11. Attachments Details of attachments (if any): The Annual Report of Invion Limited for the year ended 30 June 2025 is attached. 12. Signed Signed ___________________________ Date: 27 August 2025 Thian Chew Chairman 2 Invion Limited Contents 30 June 2025 Corporate directory Directors' report Auditor's independence declaration Statement of profit or loss and other comprehensive income Statement of financial position Statement of changes in equity Statement of cash flows Notes to the financial statements Consolidated entity disclosure statement Directors' declaration Independent auditor's report to the members of Invion Limited Shareholder information 4 5 21 22 23 24 25 26 45 46 47 49 3 Invion Limited Corporate directory 30 June 2025 Directors Mr Thian Chew, Chairman (Executive Chairman and CEO) Mr Alan Yamashita, Non-executive Director Mr Alistair Bennallack, Non-executive Director Ms Melanie Leydin, Non-executive Director Company secretary Ms Melanie Leydin Australia Business Number 76 094 730 417 Registered office Suite 2, Level 11, 385 Bourke Street, Melbourne Vic 3000 Australia P: (03) 9692 7222 E: investor@inviongroup.com W: www.inviongroup.com Share register Boardroom Pty Limited Level 12, 225 George Street, Sydney NSW 2000 P: 1300 737 760 W: www.boardroomlimited.com.au Auditor William Buck Level 20, 181 William Street Melbourne VIC 3000 Stock exchange listing Invion Limited shares are listed on the Australian Securities Exchange (ASX code: IVX) 4 Invion Limited Directors' report 30 June 2025 The directors present their report, together with the financial statements, on the consolidated entity (referred to hereafter as the 'consolidated entity' or 'the Group') consisting of Invion Limited (referred to hereafter as the 'company' or 'parent entity') and the entities it controlled at the end of, or during, the year ended 30 June 2025. Directors The following persons were directors of Invion Limited during the whole of the financial year and up to the date of this report, unless otherwise stated: Mr Thian Chew, Chairman (appointed Executive Chairman and CEO) Mr Alan Yamashita, Non-executive Director Mr Alistair Bennallack, Non-executive Director Ms Melanie Leydin, Non-executive Director (Appointed on 31 August 2024) Mr Rob Merriel, Non-executive Director (Resigned on 31 August 2024) Principal activities Invion is a life-science company that is leading the global research and development of the PhotosoftTM technology for the treatment of a range of cancers, atherosclerosis and infectious diseases. The Invion Group consists of Invion Limited and its wholly owned subsidiary, Epitech Dermal Science Pty Ltd. Invion holds the exclusive Australia and New Zealand license rights and exclusive distribution rights to Asia Pacific excluding China (other than Hong Kong, which is included in the Territory), Macau, Taiwan, Japan and South Korea to the PhotosoftTM technology for all cancer indications. It also holds the exclusive rights to the technology in Asia Pacific (excluding Greater China) for atherosclerosis and infectious diseases. Dividends There were no dividends paid, recommended or declared during the current or previous financial year. Review of operations Invion is a clinical-stage life science company that is leading the global research and development of the Photosoft™ technology for the treatment of a range of cancers, atherosclerosis and infectious diseases. The Company’s main focus during the year was progressing its clinical cancer programs. One of the most important milestones in FY25 was the commencement of the Company’s Phase I/II clinical trial for non-melanoma skin cancer (NMSC) in Queensland, Australia, to assess the safety and efficacy of Invion’s lead cancer drug candidate, INV043. NMSC Clinical Trial Early results from the conclusions from the Safety Review Committee (SRC) after the treatment of the first six patients in the trial were encouraging. The SRC did not identify any adverse events associated with the application and use of INV043 and all data suggests that the treatment was well tolerated. Feedback from clinicians indicated there were no signs of pain associated with the treatment, which is a significant benefit over other Photodynamic Therapy (PDT) treatments for NMSC. Further, there were early indications of patients responding positively to the treatment with an observable reduction in the NMSC lesion size after a single treatment cycle at 15- and 30- days post treatment, while on average, untreated patientmatched lesions increased slightly in diameter over the same corresponding periods post treatment. Moreover, the potential to use INV043 as a diagnostic tool was further demonstrated during trial. While red light of 660nm would activate INV043 to generate Reactive Oxygen Species (ROS) to kill the cancer, violet light of 405nm causes cancer cells to fluoresce. Having an effective diagnostic tool may help surgeons more accurately identify and remove cancers to minimise the risk of either missing some of the cancer margin or cutting too much of the healthy tissue. Invion has progressed to Part 2 of the study, which will include adjusting dose-light interval (time between the topical application of INV043 to the lesion and subsequent activation by light). The adaptive trial also enables other dose optimisation dimensions allowed under the protocol. 5 Invion Limited Directors' report 30 June 2025 Grant for Anogenital Trial Meanwhile, the Colorectal Surgical Society of Australia and New Zealand (CSSANZ) Foundation has awarded a $20K grant to support the upcoming anogenital clinical trial that Invion will be undertaking in partnership with the Peter MacCallum Cancer Centre (Peter Mac). The grant was awarded to Prof Alexander (Sandy) Heriot, Consultant Colorectal Surgeon and Director of Cancer Surgery at Peter Mac, to investigate the use of topically applied INV043 in combination with a PD-1 inhibitor on anogenital cancers. Examples of PD-1 inhibitors include Pembrolizumab (Keytruda, Merck), Cemiplimab (Libtayo, Regeneron), Nivolumab (Opdivo, Bristol-Myers Squibb) and Dostarlimab (Jemperli, GlaxoSmithKline). There is a pressing unmet medical need in addressing anogenital cancers. Pre-clinical studies in anal cancer conducted by Prof Robert Ramsay at Peter Mac showed INV043 and PD-1 combination therapy led to an 80% complete pathological response in mice, compared with 12.5% when PD-1 was used as a standalone therapy. Prof Ramsay was appointed as Invion’s Scientific Advisor in December last year. The safety data from the first six patients in the skin cancer trial (detailed above) is an important input into the anogenital trial. Peter Mac is preparing a submission for approval to commence this trial. To bolster scientific guidance and research direction, Invion welcomed Prof Ramsay as a Scientific Advisor to provide critical strategic guidance on Invion’s clinical trials and research programs. Prof Ramsay is an Honorary Professor at Peter Mac and was recently ranked by Stanford University to be in the top two per cent for career citations among the 100,000 most-cited scientists in the world 1. Prostate Cancer Results Another key development during the year was the release of the results from an investigator-led Phase II prostate cancer trial using a sublingual (under the tongue) formulation of INV043. The trial used six treatment cycles of INV043 as a monotherapy. It was found to be safe and well tolerated by patients with no serious adverse events experienced and all side effects reported were mild. In terms of efficacy signals, 40% of patients showed a positive response to the treatment with 10% demonstrating complete regression as measured by the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 framework – a standard way to measure the response of a tumour to treatment. Further, 44% of patients had negative Prostate Specific Membrane Antigen – Positron Emission Tomography (PSMA-PET) results three months post treatment (all patients were positive before the treatment). Collaborations & Partnerships In a separate development, Invion expanded its collaboration agreement with leading South Korean pharmaceutical group, Hanlim Pharm Co., Ltd. (Hanlim), to include oesophageal cancer under its development program for INV043. The new cancer target is in addition to primary brain malignancy, glioblastoma multiforme (GBM). Hanlim will fund and undertake pre-clinical studies on the two cancers and Invion retains all rights to the Photosoft technology, including the rights to any new intellectual property resulting from the collaboration. The loss for the consolidated entity after providing for income tax amounted to $8,807,732 (30 June 2024: Loss of $5,627,765). The Company held a cash balance of $850,373 as at 30 June 2025 and has further raised $980,000 (before costs) in July 2025 from its fully-underwritten Loyalty Entitlement Offer, announced on 13 June 2025. The Company has identified a number of material risks that may affect the success of the business over the coming periods, including some that are not directly within its control. The Company’s risk management approach involves the ongoing assessment, monitoring and reporting of risks that could impede the Company’s progress in delivering its strategic priorities. These risks are outlined below, although it is important to note that as Invion’s business continues to grow and evolve, these risks and the Company’s risk profile may change. 1 https://www.petermac.org/about-us/news-and-events/news/details/dozens-of-peter-mac-researchers-feature-in-stanford- university-s-worldwide-top-scientist-list2 6 Invion Limited Directors' report 30 June 2025 Material Business Risks to Strategy and Financial Performance in Future The Company has identified a number of material risks that may affect the success of the business over the coming periods, including some that are not directly within its control. The Company’s risk management approach involves the ongoing assessment, monitoring and reporting of risks that could impede the Company’s progress in delivering its strategic priorities. These risks are outlined below, although it is important to note that as Invion’s business continues to grow and evolve, these risks and the Company’s risk profile may change. ● Efficacy of the Compound (INV043) is proved to be ineffective or less effective that other cancer treatments: Invion continues to utilise the outsourced product manager to ensure the Compound continues to be effective (Quality) as well as continue to build/test pipeline of additional compounds in portfolio to identify additional candidates for a second cancer API. ● Invion's ability to fund ongoing studies and trials for Photosoft: Invion believes it has reached a point in the development of the technology that will give it the flexibility to be strategic in deploying capital. The Company is undertaking a skin cancer trial, which is relatively low cost to complete. It has also raised circa $1 million (before costs) after successfully completing a full underwritten Loyalty Option entitlement offer in July 2025. It may be necessary for Invion to raise additional funds in order to undertake further clinical trials, product development or fund other needs which arise. There is no assurance that such funding will be available to Invion in the future or that it will be available on acceptable terms. ● Dependence on agreements with RMWCG Invion has entered into a number of agreements with RMW Cho Group Limited (RMWCG), pursuant to which RMWCG has agreed to co-develop the PhotosoftTM technology, granted exclusive distribution rights to Invion for the PhotosoftTM technology in certain territories and agreed to fund research and development for the PhotosoftTM technology in Australia and New Zealand. A failure by Invion to comply with the terms of any of these agreements, or a breakdown in the relationship with RMWCG, without an appropriate countermeasure, could have a material adverse effect on Invion’s business, financial position or prospects. Invion has the R&D Services Agreement dated 31 August 2017 with RMWCG, pursuant to which RMWCG had agreed to fully fund certain research and development activities. As of prior ended 30 June 2024, RMWCG owed Invion approximately $4 million for the services provided under this Agreement. Invion and RMWCG are in discussions broadly regarding its licensing and other arrangements. There is a risk that Invion may not be able to successfully negotiate an expanded Photosoft licence and Invion may be required to recover the outstanding amounts from RMWCG through legal proceedings. There is no guarantee that such amounts can be quickly recovered as RMWCG is a foreign entity and this would negatively impact Invion’s relationship with RMWCG. ● Commercial and financial risk There is uncertainty surrounding the future financial performance of Invion. Invion does not currently generate revenue from product sales and any such revenue is not anticipated in the short to medium term. Invion’s ability to operate with a profit in the future will depend in part on its ability to successfully conduct clinical trials and to commercialise its products. The development and commercialisation of Invion’s technology is subject to an inherent risk of failure, including the possibility that there is no certainty of timing for any product to progress to clinical trial, or clinical trials may fail. The products developed by Invion may be uncommercial to market or otherwise not commercially exploitable, or fail to achieve the support of physicians, patients or the wider medical industry. ● CEO dependence/single point of dependency There is a risk of over reliance on key personnel and potential departure of those key employee/contractors. This risk is currently mitigated as the CEO is a major shareholder and the external contractors used are through third party companies who would have their own internal risk mitigations for this scenario. ● Over-reliance / knowledge concentration risk on some external service providers (eg, chemistry, manufacturing) The expansion of parties involved in the processes should reduce concentration of knowledge risk, and as availability of capital improves, Invion can actively identify alternatives/backup options ● Market competition – potential of emerging therapies to supersede this technology The healthcare industry can be impacted by technological advances, which may impact on the commercial success of Photosoft. The pharmaceutical and medical device industries are competitive and are constantly subject to change. Some of Invion’s competitors have substantially greater financial and human resources than Invion. Consequently, there is a possibility that other parties will develop therapies, medicines and service offerings which will compete with or supersede 7 Invion Limited Directors' report 30 June 2025 Invion’s product and intellectual property, with resulting adverse effects on Invion’s performance and profitability. However, Invion believes that its patent protected technology and distinctive method of action and applicability to multiple cancers/diseases provides levels of protection. ● Intellectual property risk Invion’s success may depend on its ability to protect its intellectual property (including any intellectual property used under licence) while operating without infringing the property rights of third parties or having third parties circumvent Invion’s proprietary rights. Such intellectual property may not be capable of being legally protected and may be subject of an unauthorised disclosure or unlawfully infringed upon by third parties. Invion may incur substantial costs in asserting or defending its intellectual property rights. ● Loss and theft of data Invion’s business could be materially disrupted by security or privacy breaches which may impact the security of information and data (including personal information and clinical trial data), unauthorised hacking, disruption, general misuse or unauthorised disclosure of a personal data (including patient data). While Invion undertakes measures to prevent and detect the occurrence of such privacy breaches, there is a risk that such measures may not be adequate. Any data breach will need to be reported to the relevant authorities and may cause substantial reputational and financial damage to the Company. Significant changes in the state of affairs In June 2024, the Company has secured funding through Share Subscription Agreement and Share Purchase Agreement (together, the “Agreements”) to provide a minimum of $2.4 million and up to $6.8 million in funding to the Company from Lind Global Fund II, LP an entity managed by New York-based The Lind Partners (together, “Lind”). During the year the Company issued 3.47 million shares for the capital raise of $0.5 million (before cost) under Share Purchase Agreement. In April 2025, Invion terminated the Share Subscription Agreement and has elected to refund $505k in cash during the period. On 16 October 2024, the Company announced consolidation of the issued share capital of the Company on the basis that every hundred (100) fully paid ordinary Shares be consolidated into one (1) fully paid ordinary Share (rounded up to the next whole number of shares), as applicable. On 9 September 2024, the Directors have exercised the options issued in lieu of Director's fees leading to an issue of 287,261 shares. On 10 December 2024, the Company issued 147,144 options for nil exercise price to the Directors of the Company in lieu of Director's fees with an expiry date of 31 October 2028. The Directors have exercised these options on 24 June 2025 and equivalent numbers of shares have been issued. On 16 December 2024, the Company issued 544,764 shares to Hudson Institute in lieu of services provided amounting to $100,618. On 14 January 2025, the Company issued 136,233 options to vendors in lieu of services provided amounting to $36,465. In March 2025, the Company raised $2 million (before issue costs) through the placement of 14.23 million shares at an issue price of $0.14 per share to institutional and sophisticated investors. In addition, investors were issued 14,825,716 free attaching unlisted options (Placement Option with an exercise price of $0.28 per option and expiring on 12 May 2028) under the Placement. On 15 May 2025, the Company issued 162,515 options to the Directors of the Company in lieu of Director's fees with an expiry date of 31 October 2028. 8 Invion Limited Directors' report 30 June 2025 On 5 June 2025, the Company created the below three subsidiaries. These Companies are 100% held by Invion and are dormant as at 30 June 2025. ● ● ● Photo Geni Pty Ltd Photo Derm Pty Ltd Photo Lung Pty Ltd There were no other significant changes in the state of affairs of the consolidated entity during the financial year. Matters subsequent to the end of the financial year Subsequent to the year end, in July 2025 the company raised $980,000 (before costs) from the issuance of 65.35 million loyalty options at 1.5 cents per loyalty option under the Entitlement Offer to the eligible shareholders. The loyalty option has an exercise price of 14 cents and an expiry date of 30 June 2027. The Entitlement Offer was fully underwritten by Blue Ocean Equities Pty Ltd. Under the Entitlement Offer upon the exercise of the loyalty options, the company will issue one (1) free piggy-back option, with an exercise price of 21 cents and an expiry date of 30 June 2027, for every two (2) Loyalty Options that are exercised by 31 December 2025. On 23 July 2025, the company issued 540,000 ordinary shares at 11 cent per share and 540,000 listed options at 1.5 cent per option to Blue Ocean Equities Pty Ltd towards the management and selling fee of 6% at the option of Blue Ocean. The fees paid is as per the underwriting agreement signed in connection with Options Entitlement Offer. On 28 July 2025, the company issued 344,620 options to the vendors in lieu of services expiring on 28 July 2029. No other matter or circumstance has arisen since 30 June 2025 that has significantly affected, or may significantly affect the consolidated entity's operations, the results of those operations, or the consolidated entity's state of affairs in future financial years. Likely developments and expected results of operations The likely developments in the operations of the Group and the expected results from those operations in future financial years will be affected by the success of management in reaching critical development and commercial milestones in its core program in the development of the PhotosoftTM technology. This could include developing and expanding existing and emerging commercial partnerships with leading global healthcare companies, securing one or more commercial transactions for the Group’s drug asset under development and expanding the exclusive licensing agreement to Photosoft with the technology’s licensor, RMW Cho Group, consistent with Invion’s previous disclosures around these negotiations. Environmental regulation Invion is required to carry out its activities in accordance with applicable environment and human safety regulations in each of the jurisdictions in which it undertakes its operations. The Group is not aware of any matter that requires disclosure with respect to any significant regulations in respect of its operating activities, and there have been no issues of non-compliance during the year. 9 Invion Limited Directors' report 30 June 2025 Information on directors Name: Title: Qualifications: Experience and expertise: Other current directorships: Former directorships (last 3 years): Special responsibilities: Interests in shares: Interests in options: Name: Title: Qualifications: Experience and expertise: Other current directorships: Former directorships (last 3 years): Special responsibilities: Interests in shares: Interests in options: Mr Thian Chew Chairman and CEO MBA Wharton (Palmer Scholar) / MA (Lauder Institute), University of Pennsylvania B. Information Systems, Monash University and a qualified Chartered Accountant Thian has over 25 years’ experience in healthcare biotech, investing and transforming business operations. He is also Co-Founder of Chronic Airway Therapeutics, a clinical stage firm focused on the treatment of respiratory diseases and Managing Partner at Polar Ventures. Thian is also an Advisory Board Member at Stanford Medicine’s Center for Asian Health Research and Education (CARE). Prior to this, Thian was an Executive Director at Goldman Sachs (New York, Hong Kong), responsible for the firm’s proprietary investments, and was a Consultant Project Manager at Morgan Stanley’s Strategic Services Group (New York). He also held a number of positions in KPMG across Asia Pacific including Director at KPMG Consulting (Singapore and Sydney) where he led several large scale operational restructuring, post-merger integration, transformation, and business performance improvement programs. As a Senior Manager at KPMG (Taipei and Melbourne), he led several business process re-engineering initiatives, and also performed financial and information technology audit, risk and assurance engagements across multiple industries. Thian is Adjunct Associate Professor at the Hong Kong University of Science & Technology, and has taught in both the School of Business and Management, as well as the Division of Life Sciences. He is also Visiting Professor at UCL Global Business School for Health. None None None 5,468,578 indirectly held 246,706 directly held 1,605,024 unlisted options Alan Yamashita Non-executive Director MPA, BA Mr Yamashita is a highly experienced corporate consultant and investment professional, with over 40 years' experience in investment management, investment banking and alternative investment throughout the APAC region. From 1999 to 2005, Mr Yamashita was President and CEO of Search Investment Group and founding CEO and CIO of Search Alternative Investment Ltd (SAIL), a major private global hedge fund and private equity investment practice headquartered in Asia. Prior to Search Investments Group, Mr Yamashita was Managing Director and Head of Asia Capital Markets for Merrill Lynch from 1996 to 1998. Mr Yamashita is currently Managing Partner at Polar Ventures and has held numerous positions as a 16-year veteran of Goldman Sachs and an advisor to various companies, including Plantation Timber Partners, Wuhan; Duty Free Shoppers, Asia; TVSN, Shanghai; and Mizuho Alternative Investments LLC. None None Chair of Nomination and Remuneration Committee Member - Audit and Risk Committee 150,053 ordinary shares Nil 10 Invion Limited Directors' report 30 June 2025 Name: Title: Qualifications: Experience and expertise: Other current directorships: Former directorships (last 3 years): Special responsibilities: Interests in shares: Interests in options: Interests in rights: Name: Title: Qualifications: Experience and expertise: Other current directorships: Former directorships (last 3 years): Special responsibilities: Interests in shares: Interests in options: Ms.Melanie Leydin Non-executive Director (appointed on 31 August 2024) BBus (Acc. Corp Law) FCA FGIA Melanie holds a Bachelor of Business majoring in Accounting and Corporate Law. Melanie is a Fellow of the Institute of Chartered Accountants and Fellow of the Governance Institute of Australia. Melanie graduated from Swinburne University in 1997, became a Chartered Accountant in 1999 and from February 2000 to October 2021 was the principal of Leydin Freyer which was acquired by Vistra in November 2021. Melanie is now the Executive Vice President of Global Soultions, South East Asia at Vistra. Vistra is a prominent provider of governance and compliance solutions and finance and accounting solutions in the Fund, Corporate, Capital Markets, and Private Wealth sectors. Melanie has over 30 years’ experience in the accounting profession and over 20 years’ experience holding Board positions including Company Secretary and CFO of ASX listed entities. Melanie has extensive experience in relation to public company responsibilities, including ASX and ASIC compliance, control and implementation of corporate governance, statutory financial reporting, reorganisation of Companies, initial public offerings, secondary raisings and shareholder relations. Unico Silver Limited (ASX:USL) Imagion Business Limited (ASX: IBX) Alchemia Limited (ASX:ACL), Medibio Limited (ASX:MEB) None Nil Nil Nil Alistair Bennallack Non-executive Director CA Mr Bennallack is currently the Chief Operating Officer and Chief Financial Officer of Village Roadshow Pty Ltd. In this capacity he also has primary responsibility for the Group Risk function. In addition he is also Chief Executive Officer of Village Roadshow Theme Parks Asia, a division of Village Roadshow Theme Parks Pty Ltd. He is the primary executive responsible for conceptualising, executing and delivering Village Roadshow’s expansion into China and Asia. He is a former member of the Village Roadshow Ltd Executive Committee, current member of the Village Roadshow Theme Parks Executive Committee and current member of all Village Roadshow Pty Ltd’s Management and Risk Committees. His previous roles have included Chief Financial Officer of Village Roadshow Ltd and General Manager Business Affairs of Village Roadshow Corporation Pty Ltd (controlling shareholder of Village Roadshow Ltd.) None None Chair of Audit and Risk Committee 235,147 ordinary shares Nil 'Other current directorships' quoted above are current directorships for listed entities only and excludes directorships of all other types of entities, unless otherwise stated. 'Former directorships (last 3 years)' quoted above are directorships held in the last 3 years for listed entities only and excludes directorships of all other types of entities, unless otherwise stated. 11 Invion Limited Directors' report 30 June 2025 Company secretary Ms Melanie Leydin was appointed as the Company Secretary on 28 October 2024. Mela