Moving Forward , The Countdown Begins

Firstly Credit where Credit is Due,

Carrying out any type of Fund Raising in the current economic climate is difficult, I know of 2 other Bio's who have come up short in the past month.

Desperate Times Call for Desperate Measures and the Company was in breach of the 2 Quarters of Operating Capital and could have easily been suspended , so although the terms might be a little hard to swallow, the CR was a very necessary evil for the survival of PAA.

The Company is now looking to transition from Discovery Research and Development toward commercialisation.
My opinion is that MND will deliver continued positive results and one article I read this morning quotes the completed data from the Phase I will be available at the end of May. This will lead to the DSMB and regulators allowing the Trial to progress to Phase II once registered on the ANZCTR.

Recent positive results from Motor Neurone Disease Trial

The placement follows a positive update last week from its ongoing Phase 1/2 Motor Neurone Disease (MND) clinical trial, which stated that five patients have now surpassed the six-month-mark without any safety issues while one patient has shown no disease progression.

It has also completed the day 28 dosing of the final patient in the second cohort, which are taking double the MPL dosage of those in the first cohort.

Importantly, all twelve patients from both Cohorts 1 and 2 have elected to continue on MPL treatment.

With the dosing of the last patient, the company expects to release results from an interim analysis of preliminary biomarkers and efficacy markers in late May as recommended by the Principal Investigator.

This is expected to allow PharmAust to proceed with the Phase 2 clinical trial with favourable efficacy biomarker results under the interim analysis.

The company will also continue with the MPL dose escalation for Cohorts 3 and 4 during the interim trial analysis to determine the optimum dose level for the Phase 2 trial.

Upcoming catalysts

Completion and results from the fully funded Phase 1/2 Human MND trial. Interim results are expected later this month.

The initial safety & PK data from the Phase 1 MND trials will fast track a Phase 2 human anti-cancer trial with PharmAust previously announcing a Principal Investigator had been identified in the US.

The Phase 2 vet cancer trial is expected to be completed mid 2023 with assay results from 10 x plasma samples expected later this month.

PharmAust is also targeting a corporate outcome this calendar year on the licensing or sale of MPL’s vet cancer applications following commercially valuable Phase 2 outcomes

The K9 Trial completion will also also instigate several Big Pharma who contacted Roger Aston the current CEO with in days of Elanco not taking up their previously inked Licensing Deal , the Company has been in ongoing Commercial Discussions now for a considerably amount of time/years.


As Roger pointed out "The Better and more comprehensive the data , The Better the deal" now with 3 years of additional data and Dogs living for hundreds of days longer than diagnosed with Lymphoma, SH are welcoming the Licensing or Sale of the Technology.


From my own perspective the K9's trials have delivered comprehensive data that will expedite Human Lymphoma Trials building upon the the Previous Phase II Human Lymphoma Trial,,




The Previous Human Lymphoma Trial was a hugely Scientific Positive where MPL Capsules demonstrated the ability to reduce the actual size of Tumors and and lesions, it is important to note that the Trial Patients had all failed Standard of Care and regrettably had extremely advanced cases of Lymphoma , in fact some had a very short life expectancy, under 60 days.
The Trial was overshadowed by the Capsules not being Palatable and but enough positive data was gained for the ANZCTR to establish there was Positive Effect of MPL vs the Cancer and the Trial parameters are still in place awaiting a Soluble and Palatable Tablet.



Sufficient data was obtained to permit proceeding to Phase II study, i.e. a safe and active dose. The study was also terminated to permit reformulation of study drug to a more palatable formulation.

This now brings us to the Newly Formulated MPL Tablets.
Pharmaust under the guidance of the CSO Richard Mollard with the assistance of two Global Giants



have created a small Palatable and Soluble Tablet that delivers an effective dose of MPL across the blood brain barrier utilising the mTOR Pathway.


This is hugely significant , additionally there are no adverse effects noted , this places PAA in an envious position when compared to the two current incumbent suppliers of medication who each garnish over $1B per annum from their treatments that cannot boast the nil adverse effects, in fact the adverse effects are significant,



Pharmaust over the past 4 years have trialed MPL against Covid/ SARs1 and SARs2 These Trials across multiple world class research institutes and facilities delivered "Remarkable Results" according to Marc Pellegrini, in fact the first results were so significant the trial was run again to establish the first results were correct.
Using an infected human baseline viral load of 35,000 ppm within 72 hours the viral load was reduced to 495 ppm. Further lengthier dosing would calculate the complete reduction in viral load to nil denying the ability for Viral cell reproduction completely.

Addititional Trialing was then carried out with



Both delivering even more positive data demonstrating the ability of MPL to fight Virus and disease.
Human Trials are eagerly awaited to demonstrate MPL in the real world environment of a Human Trial
Human Covid Trials are short by way of Nature that the Virus must be effected within the period of infection, any longer and you would have recovered due to the Virus running its course.
My personal opinion is that MPL has a very high chance of reducing the infection period and may well reduce the harm from long covid.

FDA Orphan Drug Approval
This process has a no cost application, there is no fee payable , this is to create a level playing field for new discoveries and not be dominated by Big Pharma.



My Opinion is the the FDA would welcome an Orphan Drug Status application regarding MPL vs MND, The Phase II Data from the MND Trial would support an application.
The process is regulated to only 90 days.
Significant Benefits are attached to gaining FDA Orphan Drug Status,,,
1 being multi year (7) Market Protection. 2, Being you can begin to revenue from your treatment. $$

So as you can see the finish line to gain FDA Orphan Drug status is not actually that far in the future. In fact another Bio on the ASX eneterd into discussions prior to their Phase II data being available to begin the dialogue regarding the application process, dotting i's and crossing t's readying full application and preparing the FDA.

My personal belief is that Pharmaust have made significant scientific inroads on many fronts, "Significant" Positive Scientific Data has been gained on multiple occasions over the past 3 years, regrettably for SH the company has not been able to impart SH value equal to the Significant Positive Scientific Data gained,, The Company has invested Millions into Trials , resulting in Positive data but the MC has remained Flat.

The next step
Heading Forward , the small CR that has just been completed would indicate the Funds are only a stop gap measure.
With Income predicted shortly from K9 Licensing or Sale Pharmaust will be in a strong position to immediately begin Human Trials in the Covid space and Human Oncology.
Gaining FDA Orphan Drug Status for MND would enable significant Publicity and the ability to gain revenue from the MPL Tablets for Pharmaust.

IMHO these above catalysts will easily bring an increased SP, the company must throw off the shackles of modesty and quite achievers, PAA need to strategically steal the spotlight from current ASX listed Companies and deliver the true value of MPL to the market and to reward its current dedicated SH base.

Disclosure, as a Trader I have made significant gains from Pharmaust but my belief is the real Diamonds are about to surface but will take significant and timely action from Management,, the time to strike is now, the opportunities are at hand , delays will only erode value , so from where I sit deliberate and strategic action is required, Immediately ... NZT