Invex Therapeutics : Quarterly Activities/Appendix 4C Cash Flow Report

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ASX / Media Release

24 January 2022

Quarterly Activities Report & Appendix 4C

The Company will host an investor conference call today at 12.00pm AEDT with Dr Thomas

Duthy, Executive Director, details below

Invex Therapeutics Ltd (Invex, ASX:IXC, or the Company) a clinical-stagebiopharmaceutical company focused on the development and commercialisation of Presendin™ (sustained release Exenatide) for neurological conditions relating to raised intracranial pressure, is pleased to provide an operational and corporate update to accompany its Appendix 4C cash flow statement for the quarter ended 31 December 2021.

Operational Update

Manufacturing

In December, Invex successfully completed an independent Qualified Person (QP) Audit of Peptron's manufacturing facility in Osong, Korea, which can produce over 48,000 vials of Presendin™ per month as well as one other key supplier. A satisfactory QP Audit and the subsequent certification of manufactured batches of drug product by a QP is a requirement under European Union (EU) and UK law prior to importation of manufactured drug product into the EU and or the UK for clinical or commercial purposes. The regulations specify that no batch of drug product can be released for supply prior to certification by a QP that the batch is in accordance with the relevant requirements.

The completion of the QP Audit of Peptron and one of Peptron's key suppliers of manufacturing material will facilitate the importation of Presendin™ and placebo doses into clinical sites in Europe and the UK participating in Invex's IIH EVOLVE Phase III clinical trial for the treatment of Idiopathic Intracranial Hypertension (IIH). The manufactured doses will be progressively deployed across Invex's planned clinical sites as sites are opened and patient recruitment commences.

Following the successful QP audit, Invex placed an initial purchase order with Peptron for supply of a clinical batch of Presendin™ and placebo drug product for the IIH EVOLVE Phase III clinical trial. Initial clinical batches have been produced and the Company's storage and distribution provider expects to take delivery shortly and complete necessary labelling requirements necessary for dispatch to clinical sites, once these sites are open.

IIH EVOVE Phase III Clinical Trial Preparation Progressing Strongly

During the quarter, Invex materially advanced its preparative work for commencement of the IIH EVOLVE clinical trial across a number of key areas.

Invex Therapeutics Limited │ ABN 29 632 145 334│ Level 1, 38 Rowland St, Subiaco, Perth WA 6008 │

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Firstly, the Company was pleased to finalise its overall regulatory and clinical trial strategy. The completion of this strategy was an important milestone for the Company after significant scientific and regulatory consultation. The planned, single Phase III clinical trial has been designed to meet the requirements for market approval of Presendin™ for the treatment of IIH in the EU, UK and Australia. The trial plans to enrol 240 newly diagnosed IIH patients who will be randomised to receive either once weekly sub-cutaneous injections of Presendin™ or placebo across 37 centres in Europe, UK, Australia and the United States (US).

The primary endpoint of IIH EVOLVE will assess the mean difference in Intracranial Pressure (ICP) from baseline at 24 weeks between patients receiving Presendin™ and those on placebo. Secondary endpoints will assess the relative difference in vision (Perimetric Mean Deviation (PMD) and papilloedema) and Monthly Headache Days (MHD) between the two groups over 24 weeks.

Outcomes from the IIH EVOLVE clinical trial are expected to facilitate future discussions with the US Food and Drug Administration (FDA) regarding registration of Presendin™ in the US in the future.

The Company successfully filed the first Clinical Trial Application (CTA) to commence the IIH- EVOLVE trial in Australia in the month of December as planned through an application to a specific Human Research Ethics Committee (HREC). In Australia, HRECs are required under the Therapeutic Goods Act to review and monitor all clinical trials of unregistered drugs. If successful, HREC clearance will allow Invex to commence recruitment of IIH patients under the parameters of the approved trial protocol. A number of clinical sites in Australia are planned.

Invex anticipates completing additional CTAs for the UK, Europe and the US during the 1H CY2022.

In late December 2021, Invex announced the appointment of Professor Michael Wall, MD as the Trial Steering Group Chairperson for the IIH EVOLVE Phase III clinical trial. Dr Wall is a Professor of Ophthalmology and Neurology at the University of Iowa College of Medicine and Director of the Iowa Visual Field Reading Center. He is considered a global key opinion leader in IIH, having made a significant contribution to the clinical and scientific literature pertaining to the diagnosis, treatment and management of this disease and has led a significant number of important IIH clinical trials.

Professor Wall has a distinguished career in the field of IIH, has published widely in international peer-reviewed journals, and has significant experience and expertise in the execution of clinical trials in neurology and ophthalmology for pharmaceutical companies undertaking studies in the United States and around the globe.

R&D Tax Rebate of £100k Received

In December, the Company's UK subsidiary received approximately £100k (A$184k) in a Research and Development (R&D) tax rebate from the UK government for the 2021 financial year. Invex anticipates an increase in UK rebates and the commencement of Australian R&D tax rebates in future periods as the Company accelerates R&D expenditure necessary to support our important registration directed IIH EVOLVE Phase III clinical trial.

Invex Therapeutics Limited │ ABN 29 632 145 334│ Level 1, 38 Rowland St, Subiaco, Perth WA 6008 │

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Corporate Update

Financial Summary and Analysis

The Company closed the quarter in a strong financial position with cash and cash equivalents of $31.4 million, with overall cash outflows for the quarter of $0.6 million.

Cash outflows from operating expenditure included:

• Product manufacturing & operating costs for the quarter of $0.14 million related to initial purchases of Presendin™ and placebo drug product from Invex's manufacturing partner Peptron, in preparation for the IIH EVOLVE Phase III clinical trial.
• Research & development expenditure for the quarter of $0.33 million related clinical and regulatory consultants, along with intellectual property costs related to Invex's patent and trademark portfolio. In addition, the Company incurred costs associated with direct R&D staff of $0.12 million.
• Administration and corporate costs of $0.23 million related to compliance costs associated with an ASX listed company, including ASX and Director's fees, audit and legal costs.

Aggregate amounts paid to related parties of the Company and their associates included in the above costs were $0.16 million for the quarter.

In addition, government grants and tax incentives of $0.18 million were received from the UK government for eligible FY21 R&D expenditure.

Cash outflows are expected to increase in subsequent periods as the Company prepares for the start of the IIH-EVOLVE study. Notwithstanding the increase in cash utilisation in subsequent periods, the Company is fully funded to complete the Phase III trial for Presendin™ registration purposes in the EU, UK and Australia from current cash reserves.

Investor Relations

In November, Invex hosted an interactive webcast for investors and analysts on the Company's regulatory and clinical trial strategy with Chairman Dr Jason Loveridge, Executive Director and CSO Professor Alex Sinclair and Executive Director Dr Thomas Duthy. The Company thanks investors for their participation and questions. The webcast is available on the Invex website at: https://invextherapeutics.com/presentations/

In November, Invex presented at the Bell Potter Healthcare conference to predominately institutional and private clients of the firm. A copy of the webcast and presentation is available on the Invex website https://invextherapeutics.com/presentations/.

Invex has also provided an update to its Fact Sheet as at January 2022, which will be available on the Company's website later today at: https://invextherapeutics.com/fact-sheets/.

Invex Therapeutics Limited │ ABN 29 632 145 334│ Level 1, 38 Rowland St, Subiaco, Perth WA 6008 │

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Invex Therapeutics Limited │ ABN 29 632 145 334│ Level 1, 38 Rowland St, Subiaco, Perth WA 6008 │

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Invex Therapeutics Limited │ ABN 29 632 145 334│ Level 1, 38 Rowland St, Subiaco, Perth WA 6008 │

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