2022 Moving Toward 2023

As we approach October thought it might be beneficial to change up to a new thread.

First an overview of 2022 so far.

Company has successfully manufactured the MPL Tablets at GMP grade quality.

Good manufacturing practice
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
This also enables the tablets to be manufactured anywhere in the world in facilities that meet the GMP grade benchmark.

The MPL Tablets are the common denominator for all future Human Trialing , Human Cancer, Covid and SARs 1 and SARs 2, HVTL-1 Infections and MND.

K9 Oncology Trials
The K9 Oncology Phase II Trial is drawing to an end
The Company has indicated the possibility of a Commercial Licensing Deal once statistical significance has been reached.
The CEO has mentioned Big Pharma have shown interest and are in confidential discussions at present.

The Company undertook a Trial utilising Beagles who ate the Pills freely from the ground and from Clinicians hands, this was over a 10 day period and demonstrated Pharmaust had overcome a major milestone of delivering enough MPL into the bloodstream to be beneficial and demonstrated Palatability and Tolerability.

OHD Flow Reactor
During the year the OHD reactor developed by Epichem has been adopted by Shell Oil for a Pilot Study.
The flow reactor is located at Epichem’s purpose-built state of the art laboratory at Technology Park in
Bentley, Western Australia. Epichem Pty Ltd is a wholly owned subsidiary of PharmAust Limited
(ASXAA).


Epichem OHD will advance the innovative OHD technology using biomass/feedstock flow reactor
material science. The OHD technology is a world-first with its potential to turn a wide range of waste
and biomass feedstock into valuable fuels, fine chemicals, fertilisers, agricultural growth stimulants and
ethanol

.Motor Neuron Disease MNDPharmAust receives ethics approval for Phase I trial of monepantel in motor neurone disease

● 12 trial subjects to test safety and some efficacy measures
● Special tablets to be developed and manufactured for the trial
● Trial to commence in CYQ4 2021
● Trial funded by FightMND Australia ($881,085)
● Protocol accepted and accessible on US NIH National Library of Medicine
ClincialTrials.gov website

Covid Trials
Phase 2 Human Trial in COVID-19
PharmAust has been identifying clinical centres capable of sourcing patients with the required COVID19 progression and vaccination status. Our search has focussed on Eastern Block European states
where there remain a significant number of unvaccinated patients. Encouragingly, three clinical centres
in Romania and Bosnia have expressed interest in participating and recruiting sufficient numbers of
qualifying patients for the study.
Next steps include providing protocols for the study and qualification of the identified clinical centres.
We continue to search for contingency sites including in Poland. This critical step of site selection, both
in terms of clinical suitability and patient recruitment numbers, has resulted in a delay in the
commencement of the Phase 1 COVID-19 trial.
However, this has enabled us to further review the trial rationale and, given the timing of the
commencement of the MND trial, the Board has decided to rely on the MND trial to provide the important
Phase 1 pharmacokinetic (PK) data for both the MND and COVID-19 trials. We believe this will allow
PharmAust to undertake a Phase 2 study in COVID-19 rather than a Phase 1 study. This will facilitate
faster recruitment as we have been advised by the CRO that COVID-19 infected patients generally
prefer participating in a Phase 2 study. This strategy also benefits from a financial saving to PharmAust
of about $1.5 million.

COVID MOUSE TRIAL
Further, PharmAust has signed an agreement to evaluate MPL in transgenic “humanised” mice, which
will express the receptors that the COVID-19 virus binds to in humans. Efficacy in this anti-viral model
will provide further evidence of the anti-viral effects of MPL.