Time for a New Thread with the finish line in sight and a solid strategy to follow with a new fresh Management Team in place.
Well the landscape has been reset , this quarter ahead has clear air for the new Management Team , MT is back in the big chair , well the 2 biggest seats in the room Managing Director and CEO.. pretty much full autonomy. You always want a solid relationship between the CEO and the BOD , so we can be sure of no more disruptions between the MD and CEO at the very least.
Most know exactly where PAA is at in the Trialing Continuum but for those new to PAA there is considerable and Valuable History that places the company where it is today.
One of those critical breakthrough moments has been the Design, Manufacturing , Delivery , Storage and the Utilisation of the GMP Grade Human Tablets in a hugely successful Phase I MND Trial.
The Tablets themselves have properties that assist with MND Patients being small in size and sucrose coated to provide ease of swallowing.
The 10mg Tablets delivered the ability to slow the progression of MND .
Lets just focus on that , "Slow the Progression of a Neurological Disease"
Deliver extended Life to the MND Patient by 36 months , 3 years the nearest incumbent Multi- Billion dollar drug delivers 90 days of life extension.
Pharmaust Phase I Trial Participants have only a 5% reduction in Quality of Life ,, enabling them to continue family life in the home.
Currently a New Name for the treatment is being sought ,,my pick is Neuropantel
The MND Phase I demonstrated "No Serious Adverse Effects" and was the first time PAA MPL Tablets had been used in a Human Trial.
Effectively Pharmaust look to be the FIRST in the World to deliver a Beneficial Dose of MPL across the Blood Brain Barrier. The kudos would have to be attributed to Richard Mollard PAA's previous CSO, who micronised and transformed standard MPL increasing the efficacy/ absorption by a multiple of 10. This greatly reduces the amount of MPL required and reduced pill burden on MND Patients,
With the assistance of Syngene in India
and Manufactured by Catalent based in the United States into GMP Grade Tablets
For those with an investigational mind from previous 4c's you can clearly see "The Tablets are incredibly competitively priced"
PAA has gained significant logistical information surrounding MPL Tablets .
Cost , Manufacturing Turn Around Timeframe, Efficacy , Storage, Transportation etc ,,,, this provides a high degree of
security around supply and is easily demonstrated for
scalability, which is of particular interest to Big Pharma
Upon Completion of the Trial with Positive data these tablets are Market Ready for Immediate use and returns $.
The below Diagram is not for investor purposes but an indication of value that is potentially stored inside the Company.
What I am hoping to demonstrate is the reduction in risk as PAA's has progressed through the trialing continuum.
Human Oncology
PAA has completed a Human Phase I Oncology Trial , this was completed with a capsule that was neither Tolerable or fully Soluble.
Never the less MPL reduced Tumor Burden in Cancer Patients that had failed all previous standard of care, enough Positive data was collected to enable the progress to a Phase II "Once a New Tablet was formulated" The Trial is still available on the ANZCTR.
There are no Oncology Companies I am aware of with regulatory approval to carry out a Human Phase II Oncology Trial with a MC under $100m on the ASX,,, this is utilised here for comparative Value.
Covid
PAA invested 2 years in the pursuit of SARs / Covid resulting in 3 independent Research Institutes testing MPL vs Covid , ALL Trials delivered resounding positive data but the stand out was the Walter and Eliza Hall Foundation that provided data that demonstrated MPL reduced the Viral Load by 95% (was actually 99% but the ASX boffins weren't happy so was reduced to 95% as certainty) in fact MPL was quoted as "Remarkable"
A Humanised Mouse Trial was touted by the previous BOD for quite some time ,, but I guess that's why they are now not the BOD...
Dilution 5 was the absolute victor reducing the viral load from 35,000 ppm to 469 ppm in 72 hours of exposure to MPL.
The SP shot up to 26c and the MC increased by $60m
MND
In very recent History the MND Phase I results catapulted the SP to a high of 53c MC well north of $220m ,
This possibly could have been amplified as the results were released after market close and the next days Media was Lacking and Weak.
Since then sleuths would have noted the change in PR firm.
Pharmaust is now prepped and ready to proceed to Phase II with Healey who have 70 sites ready for recruitment. Statistical Analysis provided by the Berry Institute from a depth of MND Patient data of estimated 8,000 MND Patients.
FDA Designation "well it says it all" the data was so compelling with no serious adverse effects , in the first application MPL was awarded FDA Designation ,,, the first stage toward FDA Orphan Drug Approval..
Risk Reduction
Risk is the enemy of certainty ,, Big Pharma BUY Certainty , Big Pharma want to be as close to revenue as possible and PAA can now demonstrate that with the next Phase II " in fact 24 weeks into Phase II with Positive Data" how close to Market and FDA Approval the company is strategically placed.
Value
Well IMHO PAA is criminally undervalued ,, years of delays have plagued the company , previous communications "I use that term lightly" was almost non existent , Market Awareness was minimal , Company dialogue was Poor and investment toward correcting the Market persona of a Research Institute was ignored, The company was hitting 4's and 6's but not a single run was making it onto the SP scoreboard.
IMHO the SP should be sitting in the mid 40c range ,, my opinion is based on Investing and Trading specifically Biotech on the ASX for 19 years.
So why does a Trader have so much interest in a simple little Speculative Biotech.
1, PAA is one of the closest ASX Companies to a near term Reward
2, Previous Market Messaging crippled any kind of value build
3, First in Class Medicine , This is not a same Same Drug entering a cluttered market place , in fact 2 of the Multi Billion dollar incumbents have recently been found wanting....... poor data has seen a Treatment removed from market.
Gains ,, yes as an Investor , doesn't matter if you are a Long Term player or a Trader , Investors seek a return on invested capital, predictions here at PAA are wide and varied I personally can see a price of between $1 and $2 a share in the next 24 months,,,, BUT the SP requires traction to be a $1 share it first needs to be a 50c , 60, 70, ......share, plain and simple.
Management need to strategically build on value , Market Messaging is crucial , you can't sell a secret , PAA is far from a secret today , incredible inroads have been made by Michael Thurn , he is out front , he responds to communications his presentations are concise and engaging.
In closing , PAA needs to keep the company current through applied Market Messaging , The Simple Equation is the greater the Awareness the Greater the Participation as this delivers Demand for the Shares. Awareness + Participation = Demand = Competition for equity.
Best of Luck to all Investors
NZT
Disclosure , yes I sold a million shares during Covid and Exited all my Holdings including PAA earlier this year.
PAA was the first to Buy back into my portfolio which ranges between 14 and 16 Biotechs.
PAA is not my largest holding.
Only Other 2 first in class Treatments CHM and SNT.
(20min delay)