Chief Operations Officer Mr Carl Stubbings BAppSc (appointed 28 July 2020 - resigned 31 August 2021) Mr Stubbings has considerable experience commercialising diagnostic products. His previous executive roles include Senior Vice President for Panbio USA Ltd, Vice-President of Sales and Marketing for Focus Diagnostics, a subsidiary of Quest Diagnostics and Chief Business Officer at Benitec Biopharma Limited (ASX: BLT, NASDAQ: BNTC). He was previously a Non-Executive Director of Analytica Medical Limited (ASX: ALT) and Sienna Cancer Diagnostics Ltd for which he served as Managing Director from November 2019 until July 2020. REVIEW OF OPERATIONS Information on the operations of the Group during the financial year and up to the date of this report is set out separately in the Annual Report under Review of Operations. LEGAL SETTLEMENT The Walker and Irminger legal proceeding against the Company was finally settled on 28 November 2022, with no admission of liability. Under the terms of the settlement the plaintiffs received the BARD1 Lung Cancer Test (LCT) intellectual property (IP) and a lump-sum payment of A$1 million (inclusive of GST) that included an obligation to commit $300,000 to the development of the LCT. INOVIQ has retained the Breast and Ovarian Cancer IP and will receive 10% of future sales of any BARD1 LCT until the expiry of relevant patents, and 5% thereafter. The settlement avoided the costs, inconvenience and uncertainty of litigation, and allowed the proceeding to be dismissed with no costs ordered. The Intellectual Property associated with the BARD1 Lung Cancer Test was housed within the Group’s wholly owned Swiss subsidiary, BARD1AG SA, the control of which was given up when the shares were transferred to the plaintiffs as part of the settlement during the current period. MATERIAL BUSINESS RISKS AND INHERENT RISKS OF INVESTMENT IN BIOTECHNOLOGY COMPANIES There are several inherent risk factors both specific to the development and commercialisation of medical devices, including diagnostics to a marketable stage which may impact the future operating, financial performance and viability of The Group. The material business risks that are likely to influence the prospects of the Group include: Risk Explanation Product Development There are many risks inherent in the development of diagnostic products, including that projects can be delayed or fail to meet outcomes or demonstrate any benefit, or research may cease to be viable for a range of scientific, regulatory and commercial reasons. INOVIQ’s diagnostic pipeline product will require further research development and validation, and future clinical studies, which carry the risk of technology transfer failure, clinical validation failure and other potential adverse outcomes. Regulatory review or approval may be required to conduct clinical studies in some jurisdictions, and there is no assurance that any regulatory or review body will allow INOVIQ to undertake such studies or that approvals to conduct such studies will be granted in a timely manner. Any delays in securing relevant approvals from regulatory or review bodies may result in substantial delays and/or increases in costs. Commercialisation It is likely that INOVIQ will need to form marketing and/or product development alliances with third parties for INOVIQ products in countries which INOVIQ seeks to commercialise (subject to ongoing legal and regulatory compliance and financial viability to market or develop such products). INOVIQ will rely on its ability and that of its partners to develop and commercialise its products in order to create future revenue. Any products developed by INOVIQ will require extensive clinical testing, regulatory approval and significant marketing efforts before they can be sold and generate revenue. INOVIQ’s efforts to generate revenue may not succeed for a number of reasons including issues or delays in the development, testing, regulatory approval, marketing or reimbursement of these products or services. There is no assurance that suitable partnerships will be secured or commercialise INOVIQ products, which may have adverse impacts on INOVIQ’s operating results and financial position. 25 Annual Report 2023
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