Investor update
Released
Released
Announcement PDF
Investor update
14 May 2024 – Perth, Australia: PharmAust Limited (ASX: PAA & PAAOA) (“PharmAust” or “the
Company”), a clinical-stage biotechnology company, announced several updates following recent
changes to the Board of Directors and management team.
The first meeting of the new PharmAust Board was convened on Monday 13 May 2024. This update is
provided to outline work that is now underway to strengthen the foundation of PharmAust whilst
providing an overview of the forward direction for the Company.
Changes to the Board of Directors
As previously announced, transitional arrangements have been implemented by the Company that
include the appointment of Mr Sam Wright as Interim Chairman of PharmAust, Mr John Clark as Interim
CEO and Managing Director and Mr Marcus Hughes as Non-Executive Director.
PharmAust advises that Mr Neville Bassett AM has resigned as a Non-Executive Director of the
Company.
Work has commenced to recruit additional experienced Directors who will strengthen the PharmAust
Board and bring a renewed focus on good corporate governance, effective strategy, shareholder
engagement and commercial acumen as the company enters a transformational stage.
The Company is prioritising this task and will update shareholders on the appointment of Directors as
work progresses. All appointments will be presented to shareholders for ratification at the next Annual
General Meeting. Similarly, the establishment of permanent management arrangements will be
progressed once the new Board has been finalised.
Interim Chairman Sam Wright added: “Our thanks go to Neville for his service as a Director of
PharmAust for the past five and a half years, during which time he provided calm, well considered
counsel to the Company. We wish him the best in all future endeavours.”
Strategic focus
PharmAust’s Board is focused on delivering shareholder value as it pursues the commercialisation of
monepantel (MPL) for the treatment of human neurodegenerative diseases.
The recently completed Phase 1 MEND study of MPL in MND/ALS has shown that the drug crosses the
blood-brain barrier and is safe to use at therapeutically meaningful doses in this vulnerable patient
cohort. Additionally, preliminary efficacy data shows that the administration of MPL at a dose of 10mg/kg
may slow the progression of MND/ALS by up to 58% and increase life expectancy by as much as 56.5
months, depending on the severity of the disease at baseline. These outcomes are especially notable
compared to currently approved treatments, which only extend life expectancy by 2 to 6 months.
PharmAust has lodged an application for Orphan Drug Designation (ODD) with the US Food and Drug
Administration (FDA) for the treatment of MND/ALS with MPL, which is expected to be determined by
mid-June. ODD status carries a suite of concessions and benefits, including tax credits for clinical trials,
exemptions from user fees and the potential for 7-years of market exclusivity upon approval.
PharmAust Limited ABN 35 094 006 023. Suite 116, 1 Kyle Way, Claremont, Western Australia
Tel: 08 9202 6814 Fax: 08 9467 6111
www.pharmaust.com
Work on the design and implementation of a pivotal adaptive Phase 2/3 clinical trial of MPL in MND/ALS
is well progressed. Trial commencement is anticipated in H2 CY24, subject to necessary approvals.
Given their similar pathogenesis, pre-clinical work is set to commence exploring the utility of MPL as a
treatment in other human neurodegenerative diseases, such as Alzheimer’s Disease and Parkinson’s
Disease. This work is being undertaken to help build the Company’s understanding of the potential for
MPL to be useful in more common neurodegenerative diseases, which will inform the addressable
market for MPL.
Further updates
PharmAust has experienced significant change over recent weeks. The Board would like to extend its
thanks to shareholders for their understanding, loyalty, commitment and patience as the Company
undergoes this important transformation.
The Board is more determined than ever to pursue the commercialisation of MPL in human
neurodegenerative diseases and looks forward to providing further updates to shareholders as we enter
this exciting new phase.
In line with this, an investor webinar will be held with Managing Director John Clark, as detailed below.
Investor webinar
PharmAust will be holding an investor webinar this Friday 17 May at 11:00am AEST to provide an
update on recent announcements and the strategy of the Company looking forward.
Shareholders, investors and interested parties are invited to register for the webinar at:
https://us02web.zoom.us/webinar/register/WN_C5HBbU1hRgmFVraT1cve8g
A recording will be available at the above link shortly after the conclusion of the live session, and the
replay will also be available via the Company’s website and social media channels. Questions can be
submitted in advance to matt@nwrcommunications.com.au
The Board authorises this announcement.
Enquiries:
John Clark
Managing Director
investorenquiries@pharmaust.com
P +61 (8) 9202 6814
F +61 (8) 9467 6111
W www.pharmaust.com
Media:
Matthew Wright
NWR Communications
matt@nwrcommunications.com.au
0451 896 420
PharmAust Limited ABN 35 094 006 023. Suite 116, 1 Kyle Way, Claremont, Western Australia
Tel: 08 9202 6814 Fax: 08 9467 6111
www.pharmaust.com
About PharmAust Limited:
PharmAust Limited is listed on the Australian Securities Exchange (ASX Code: PAA). PAA is a clinical-stage
biotechnology company developing therapeutics for human and animal health applications. The company is
focused on repurposing monepantel (MPL) for human neurodegenerative diseases.
MPL is a potent and safe inhibitor of the mTOR pathway. This pathway plays a central role in the growth and
proliferation of cancer cells and degenerating neurons. The mTOR pathway regulates the cellular “cleaning
process,” where toxic protein is broken down into macromolecules to be reused. This autophagic process is
disrupted in most neurodegenerative diseases, including motor neuron disease (MND/ALS).
PAA’s lead MPL program is for the treatment of MND/ALS, a rare, incurable disease. The company recently
announced positive top-line results for its Phase 1 study in patients with MND/ALS. PAA anticipates
commencing enrolment in its pivotal registration adaptive Phase 2/3 clinical study in H2 CY 2024 that could
lead to accelerated approval with the US Food and Drug Administration in 2026.
The Neurodegenerative Disease Market size is estimated at USD 55.12 billion in 2024, and is expected to
reach USD 77.82 billion by 2029, growing at a CAGR of 7.14% during the forecast period (2024-2029).1
1
https://www.mordorintelligence.com/industry-reports/neurodegenerative-disease-market
PharmAust Investor Hub:
We encourage you to utilise our Investor Hub for any enquiries regarding
this announcement or other aspects concerning PharmAust. This platform
offers an opportunity to submit questions, share comments, and view video
summaries of key announcements.
Access the investor hub by scanning the QR code or visiting:
https://investorhub.pharmaust.com/
PharmAust Limited ABN 35 094 006 023. Suite 116, 1 Kyle Way, Claremont, Western Australia
Tel: 08 9202 6814 Fax: 08 9467 6111
www.pharmaust.com
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