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

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ASX / Media Release

6 July 2022

June Quarterly Activities Report & Appendix 4C

The Company will host an investor conference call today at 11.00am AEST 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 30 June 2022 (Q4 FY22).

Operational Update

IIH EVOLVE Phase III Clinical Trial

During the quarter Invex made considerable progress towards the commencement of its global IIH EVOLVE Phase III clinical trial for patients with Idiopathic Intracranial Hypertension (IIH). Based on extensive CMC, clinical and regulatory input, the Company successfully compiled a number of key documents, including the Investigational Medicinal Product Dossier (IMPD) for Presendin™, Investigator's Brochure and Study Protocol required for commencement of the IIH EVOLVE study in the European Union, United Kingdom (UK) and in the US following Food and Drug Administration (FDA) approval.

In addition, the IIH EVOLVE clinical trial design was submitted and accepted onto the leading database of privately and publicly funded clinical studies conducted around the world, clinicaltrials.gov (assigned identifier: NCT05347147).

Clinical supplies of both Presendin™ and placebo drug product manufactured by Peptron under the terms of the Collaboration and Manufacturing Agreement signed in 2021 are currently awaiting customs clearance for labelling in the US before dispatch to the initial clinical sites.

Late in the quarter, Invex secured its first regulatory approval for the trial, with the Medicines and Healthcare products Regulatory Agency (MHRA) clearing the Company's Clinical Trial Authorisation (CTA) to commence the IIH EVOLVE Phase III clinical trial in the UK. In addition, Invex received a favourable ethical opinion from a Research Ethics Committee (REC), which was also a requirement prior to commencing the trial in the UK. Invex intends to open a number of clinical sites across the UK and will now progress institutional contracts to facilitate the commencement of patient recruitment.

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Executive Director and Chief Scientific Officer presented as part of the IIH Symposium titled "Piecing the jigsaw together - new insights to IIH pathophysiology."

Noting the scientific merit of the Invex Phase II PRESSURE trial researchers, Dr James Mitchell presenting on behalf of the Invex Phase II PRESSURE study investigators, was awarded Best Abstract by a resident at the 48th Annual Meeting of the North American Neuro-Ophthalmology Society (NANOS) held in February and the award for Best Scientific Paper at the 92nd Aerospace Medical Association Annual Scientific Meeting

The peer review process for Invex's Phase II PRESSURE trial by way of numerous presentations at specialist medical conferences has resulted a strong level of scientific and medical interest in the IIH EVOLVE Phase III trial and has greatly facilitated discussions relating to participation in the trial.

Corporate Update

Financial Summary and Analysis

The Company closed the quarter in a continued strong financial position with cash and cash equivalents of $29.3 million (Q3 FY22: $30.4 million), with overall cash outflows for the quarter of $1.0 million (Q3 FY22: $1.0 million).

Cash outflows from operating expenditure included:

• Research & Development expenditure for the quarter of $0.60 million (versus $0.67 million in Q3 FY22) reflected costs associated with the Company's contract research organisation managing the Phase III trial, along with clinical and regulatory consultants, and intellectual property costs related to Invex's patent and trademark portfolio. In addition, the Company incurred costs associated with direct R&D staff of $0.21 million (versus $0.16 million in Q3 FY22).
• Administration and corporate costs of $0.24 million (versus $0.21 million in Q3 FY22) include compliance costs associated with an ASX listed company, 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 $0.24 million for the quarter (versus $0.30 million in Q3 FY22).

Government grants and tax incentives were Nil compared to $0.18 million in Q3 FY22. As the Company is undertaking active R&D in Australia with the Phase III trial, Australian government R&D Tax Incentives are expected to be recognised in future financial years.

As previously stated, cash outflows are expected to increase in subsequent periods as the Company commences recruitment for the Phase III IIH-EVOLVE trial. Notwithstanding the increase in cash utilisation in subsequent periods, the Company is fully funded to complete this trial for Presendin™ registration purposes in the EU, UK and Australia from current cash reserves.

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Investor Relations

Invex has provided an update to its Fact Sheet as at July 2022, which is available on the Company's website at: https://invextherapeutics.com/fact-sheets/.

The Company also updated its website (www.invextherapeutics.com) during the quarter. The new website went live in early May 2022.

Investor Conference Call

The Company will host an investor conference call today at 11.00am AEST with Dr Thomas Duthy, Executive Director.

Details of the call are set out below.

In order to pre-register for the conference call and avoid a queue when calling, please follow the link below. You will be given a unique pin number to enter when you call which will bypass the operator and give you immediate access to the event. Investors are advised to register for the conference in advance by using the Diamond Pass link to avoid delays in joining the call directly through the operator:

https://s1.c-conf.com/diamondpass/10023168-sams22d.html

Alternatively, you may dial in with the following details, approximately five minutes before the scheduled start time and provide the Conference ID to an operator.

Conference ID: 10023168

Participant Dial-in Numbers:

Australia Toll Free: 1800 908299

Australia Local: +61 2 9007 8048

New Zealand: 0800 452 795

Canada/USA: 1855 624 0077

Hong Kong: 800 968 273

Japan: 006 633 868 000

China: 108 001 401 776

Singapore: 800 101 2702

United Kingdom: 0800 0511 453

- ENDS -

This release dated 6 July 2022 has been authorised for lodgement to ASX by the Board of Directors of Invex Therapeutics.

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For more information, please contact:

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@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 Presendin™. 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.