Invex Receives Regulatory Approval for IIH EVOLVE in France

Invex Therapeutics Limited │ ABN 29 632 145 334│ Level 2, 38 Rowland St, Subiaco, Perth WA 6008 │ ASX / Media Release 21 April 2023 Invex Receives Regulatory Approval for IIH EVOLVE in France Invex Therapeutics Ltd (Invex, ASX:IXC, or the Company) a clinical-stage biopharmaceutical company focused on the development and commercialisation of Presendin™ (sustained release Exenatide) for neurological conditions relating to raised intracranial pressure , today announces the approval to commence the IIH E VOLVE Phase III clinical trial has been received from the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) in France for patients with Idiopathic Intracranial Hypertension (IIH) along with an approved application to the Ethics Com mittee CPP (Comité de Protection des Personnes). CPP clearance is also required prior to the commencement of a clinical trial in France. Invex intends to open up to six clinical sites in France for IIH EVOLVE. Professor Alex Sinclair, Executive Director and Chief Scientific Officer of Invex said “This approval from the ANSM/CPP in France completes our competent authority strategy in Europe, where IIH patients across Germany and France will be participating in this important Phase III clinical trial. We certainly look forward to working with our French collaborators as recruitment commences in the coming months ahead. We have now secured the requisite regulatory approvals in all territories globally we intend to enrol patients, including Israel just yesterday.” IIH EVOLVE is a randomised, placebo-controlled, double-blind trial that will randomise 240 pat ients with newly diagnosed IIH to determine the efficacy and safety of Presendin ™ versus placebo, administered once week ly over 24 weeks . The primary endpoint of the trial is the change in intracranial pressure from baseline, with key secondary endpoints related to vision and headache outcome measures. Invex intends to open up to 40 clinical sites globally . Information on the trial is available at clinicaltrials.gov under Identifier NCT05347147. - ENDS - This release dated 21 April 2023 has been authorised for lodgement to ASX by the Board of Directors of Invex Therapeutics. For more information, please contact: Company/Investors Dr Thomas Duthy Executive Director [email protected] +61 402 493 727 Media Margie Livingston Ignite Communications [email protected] +61 438 661 131 Invex Therapeutics Limited │ ABN 29 632 145 334│ Level 2, 38 Rowland St, Subiaco, Perth WA 6008 │ 2 To subscribe to Invex email alerts, please visit www.invextherapeutics.com and follow us on Twitter @InvexThera_ASX About Invex Therapeutics Ltd Invex is a biopharmaceutical company focused on the repurposing of an already approved drug, Exenatide, for efficacious treatment of neurological conditions derived from or involving raised intracranial pressure, such as Idiopathic Intracranial Hypertension (IIH), acute stroke and traumatic brain injury. Invex has trademarked its repurposed Exenatide as Pre sendin™. www.invextherapeutics.com. About Idiopathic Intracranial Hypertension (IIH) IIH features severely raised intracranial pressure which causes disabling daily headaches and can compress the optic nerve . The usual age of onset is 20 -30 years, and it is most common in women who are obese. IIH is a rapidly growing orphan indication: its incidence has increased by more than 350% in the last 10 years. About Presendin™ Presendin™ is a once per week, sub -cutaneous, sustained -release (SR) Exenatide microsphere formulation originally developed by Peptron, Inc. (KOSDAQ: 087010). In September 2021 Invex entered into an exclusive collaboration, manufacturing and supply agreement with Peptron for Presendin™ in IIH for all major markets, with the exception of South Korea. Exenatide is a small peptide and a synthetic version of the GLP-1 agonist exendin-4, which is currently approved for the treatment of type 2 diabetes. In 2017, Invex received orphan drug designation for Exenatide in IIH from the US Food and Drug Administration and European Medicines Agency. About the IIH EVOLVE Clinical Trial The Phase III IIH EV OLVE trial is a randomised, placebo -controlled, double-blind, multi-centre trial that will randomise 240 patients with newly diagnosed IIH to determine the efficacy and safety of Presendin™ versus placebo, administered once weekly. Patients with a confirmed diagnosis of IIH will be randomised on a 1:1 basis to either Presendin™ or placebo for 24 weeks. The primary endpoint of the trial is the change in intracranial pressure (ICP), as measured by lumbar puncture, at baseline and at 24 weeks. Secondary endpoints include the change in perimetric mean deviation (PMD), papilloedema and monthly headache days over 24 weeks. IIH EVOLVE is designed to meet the requirements for market approval of Presendin ™ for the treatment of Idiopathic Intracranial Hypertension (IIH) in the European Union (EU), United Kingdom (UK) and Australia. Further study details can be found at clinicaltrials.gov website under Identifier NCT05347147 or by visiting: https://clinicaltrials.gov/ct2/show/NCT05347147.

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