Media clarification

The article in The West Australian quoted PharmAust CEO Dr Michael Thurn as saying: “Based on the numbers of patients out there with MND, this drug could be a blockbuster. It could be a drug that makes more than $1 billion in sales.”

PharmAust clarifies that this is not a forecast nor revenue projection. The Company is continuing development of the drug (monepantel) including the forthcoming global pivotal registration Phase 2/3 clinical study scheduled to start mid-2024, and any potential sales of the drug will be subject to these study outcomes, regulatory approval and various pharmaceutical reimbursement schemes.

The quote was provided based on the potential for sales of monepantel for the treatment of motor neurone disease (MND) / amyotrophic lateral sclerosis (ALS), should it be approved in major regulatory jurisdictions such as the United States (US) and Europe. Relevant data on MND/ALS including the prevalence of disease, size of market and the list price of recently approved drugs for orphan diseases and MND/ALS are summarised as follows:

• In the US and western Europe it is estimated there is more than 37,000 and 56,000 patients with MND/ALS, respectively, and more than 268,000 globally (1)

• The MND/ALS treatment market was more than USD $9 billion in 2022 and is estimated to each USD $23 billion by the end of 2035 (2)

• In 2021 the median treatment cost was USD $218,872 for orphan drugs (range USD $237 to USD $1,272,021) (3)

• The last three drugs (QalsodyTM, Radicava®, and RelyvrioTM) that received US Food and Drug Administration (FDA) approval for the treatment of MND/ALS each have an annual cost of between USD $150,000 to USD $200,000 (4)

• RelyvrioTM, referenced in the recent media coverage, generated USD $381 million in sales during 2023, its first year from launch (5)

To the extent that the quote could be considered a financial forecast, PharmAust retracts the statement as it does not have a reasonable basis for the targeted sales figure at this stage. Investors should not rely on the revenue target mentioned in the article as a basis for investment decision on the Company.

1-Park J, Kim J-E and Song T-J (2022) The Global Burden of Motor Neuron Disease: An Analysis of the 2019 Global Burden of Disease Study. Front. Neurol. 13:864339. doi: 10.3389/fneur.2022.864339

2-https://www.researchnester.com/reports/motor-neuron-disease-treatment-market/3781 3-Althobaiti H, Seoane-Vazquez E, Brown LM, Fleming ML, Rodriguez-Monguio R. Disentangling the Cost of Orphan Drugs Marketed in the United States. Healthcare (Basel). 2023 Feb 13;11(4):558. doi: 10.3390/healthcare11040558. PMID: 36833091; PMCID: PMC9957503. 4-https://endpts.com/biogen-prices-new-als-drug-at-more-than-14k-per-dose/

5-https://edition.cnn.com/2024/03/08/health/als-drug-relyvrio-fails-trial/index.html