Paradigm Bio of Australia recently announced not only a terrible result in their major Phase III test (clinical trial) but they have been Voluntary Suspended.

That's the worst right? That means all shareholders funds have evaporated completely and there is not going to be any chance of any recovery, right? I should bury me head in the sand and never comment about this stock ever again?

Mozz should do this?

Wrong.

Huh?

Yes they failed totally...but like a Year 12 exam consisting typically of three parts:

1. Multiple Choice
2. Short Answer
3. Essay

Paradigm managed a super stellar result in two out of three parts (They failed USA, but allegedly passed the rest) but failing one of the sections was enough to fail overall.

In a Phase three, you can't just pluck out a Sub Group unless you negotiated that from the onset. So what I mean is that if you fail one region badly enough, it doesn't matter if you got a stellar result in other regions...

So what happened?

Well, Missing Data.

What does that mean?

We will need to get more info from them at a future point, typically it may mean that not all data was captured correctly. Usually this is the death knell. BUT it only happened in ONE market out of four. But there is some light here that MAY mean PAR ain't dead.

A couple of days ago there was an ASX ann. It stated the following:

https://preview.redd.it/2raxr5dt2nuh1.png?width=733&format=png&auto=webp&s=697e2f241ae95e7c6513fef663e7b4e341993572

My red underline introduced above.....EX USA data looks to be "Encouraging".

The above announcement did NOT come from PAR...it comes from the Voluntary Administrator.

These guys are totally independent. Them putting out such a statement carries real merit at this juncture.

We will need to wait for a further announcement declaring exactly what this data means, what it infers, but if it is shows that Australia, Moldova and HK indeed showed stellar results while the USA wasn't great, there is definite hope for us as a company to proceed.

Why? Because it demonstrates that the failure of the PIII wasn't because the drug doesn't work, it's because of some other extraneous (execution failure) reason. The drug actually not only worked but it completely defeated & crushed placebo in the other three regions...there was material separation between the drug (active) and placebo and importantly, the safety data was immaculate. (Subject to well, data)

^(.)

This one, is not yet dead.

^(.)

Sure, we might have to undergo some pain as shareholders (think recapitalisation, raising of new funds, the formulation of a new P3) ... but if it rises like a phoenix out of the swamp of a failed P3...this still could be the biggest and best performing OA drug all time. A few years behind...but a total success all the same...

https://preview.redd.it/xjiwchrv2nuh1.png?width=1045&format=png&auto=webp&s=7cf43bfba7ef1b0bfa8737c34bbaef4c9db590da

Can this happen? Well we will know in a number of week's time.

Do watch this space.

I still, while it not at all being advice, highly commend this one to you!

ps: I've always stated there is risk with any Bio Pharma Investment play, this is no different, but despite all that has happened, this is still me number one pick.

pps: Not advice

.

^(.)

REFERENCE:

https://paradigmbiopharma.com/announcements/7777875

Last week the company that I follow the most had a very different type of ASX announcement.

It was an invitation...not to invest....it was an invitation for...a lunch!

Huh?

Yep, all shareholders of PAR are invited to RSVP by the 11th of Sep. There aren't a lot of places available for the lunch update in Melbourne on the 23rd...but you are welcome to apply if you are a holder.

https://preview.redd.it/niljh6lwb3oh1.png?width=711&format=png&auto=webp&s=1d86d7e0879f95e4ad997792686abed6bb43674e

There are a few (very few) examples of this in the past for any ASX listed companies...it is rare.

This tells me two things:

1. They are confident that the upcoming Interim Analysis (IA) for the Registrational Globally Harmonised Phase 3 isn't going to be in October or beyond, it will be sometime in September.
2. They are confident.

Well, you imagine a lunch and they don't pass their Interim Analysis. The same lunch could get quite messy if that were the case.

https://preview.redd.it/66chyarxb3oh1.png?width=678&format=png&auto=webp&s=5b34fba41b7c8adc6543400b62548c2fd3e91814

A beautiful lunch could get sour quite quickly in the wrong conditions?

So what is all this about an Interim? It's a stage in the middle of a trial where the sponsor has a read out. In Par's case there are three distinct outcomes that are possible at IA:

1) Futile

The data ain't great, in fact the Placebo arm is just as good. The Drug is futile and it is not worth continuing! I give this less than 1% chance of occurring.

2) Pass

The drug is working, there is some separation between the Active (The drug, Pentosan) and the Placebo. It is worth continuing, at this rate PAR should get a pass at the 100% milestone due early 2027. I rate this at about 65% chance of happening...

3) Early Success

Mate, the drug is so good, there is such material and clinically viable separation between the two said cohorts that PAR have realistically already achieved their 100% result despite the fact that IA is only a readout when 50% of the patients are reporting. In other words, there is little to no real way PAR can fail. I rate this at about 30 to 40% chance.

Get this and it's a real celebration.

There are NO Osteoarthritis (OA) drugs that can alleviate pain as safely as Pentosan can, there are certainly no drugs that can or have been shown to modify the trajectory of the disease of OsteoArthritis and to do so safely and with such duration. No drugs show both symptomatic relief along with structural positive manifestations, simultaneously and systemically.

Get this and the PAR shares are going to re-rate like crazy (my views).

We have less than 3 weeks for this read out.

Good luck holders of PAR!

.

Disclaimer: I own shares in Paradigm, none of the above is advice. There is risk in such speculative stocks like Par.

Last week the company that I follow the most had a very different type of ASX announcement.

It was an invitation...not to invest....it was an invitation for...a lunch!

Huh?

Yep, all shareholders of PAR are invited to RSVP by the 11th of Sep. There aren't a lot of places available for the lunch update in Melbourne on the 23rd...but you are welcome to apply if you are a holder.

https://preview.redd.it/bpj1w5ceq0oh1.png?width=711&format=png&auto=webp&s=6d1c8aeb932874c29ed9b0b8aa20ccef4183a491

There are a few (very few) examples of this in the past for any ASX listed companies...it is rare.

This tells me two things:

1. They are confident that the upcoming Interim Analysis (IA) for the Registrational Globally Harmonised Phase 3 isn't going to be in October or beyond, it will be sometime in September.

2. They are confident.

Well, you imagine a lunch and they don't pass their Interim Analysis. The same lunch could get quite messy if that were the case.

A beautiful lunch could get sour quite quickly in the wrong conditions?

So what is all this about an Interim? It's a stage in the middle of a trial where the sponsor has a read out. In Par's case there are three distinct outcomes that are possible at IA:

1) Futile

The data ain't great, in fact the Placebo arm is just as good. The Drug is futile and it is not worth continuing! I give this less than 1% chance of occurring.

2) Pass

The drug is working, there is some separation between the Active (The drug, Pentosan) and the Placebo. It is worth continuing, at this rate PAR should get a pass at the 100% milestone due early 2027. I rate this at about 65% chance of happening...

3) Early Success

Mate, the drug is so good, there is such material and clinically viable separation between the two said cohorts that PAR have realistically already achieved their 100% result despite the fact that IA is only a readout when 50% of the patients are reporting. In other words, there is little to no real way PAR can fail. I rate this at about 30 to 40% chance.

Get this and it's a real celebration.

There are NO Osteoarthritis (OA) drugs that can alleviate pain as safely as Pentosan can, there are certainly no drugs that can or have been shown to modify the trajectory of the disease of OsteoArthritis and to do so safely and with such duration. No drugs show both symptomatic relief along with structural positive manifestations, simultaneously and systemically.

Get this and the PAR shares are going to re-rate like crazy (my views).

We have less than 3 weeks for this read out.

Good luck holders of PAR!

.

Disclaimer: I own shares in Paradigm, none of the above is advice. There is risk in such speculative stocks like Par.

Well first the Bad news.

Another OA candidate didn't have very good news last night. Kolon Tissue Gene had their 2 year P3 (first of two trials) out and the results were a bit poo - pooie.

Yeah I'm being a bit flippant but kinda befitting as they had some real dodgy data a while back when they were supposed to source cells from Chondrocytes and they used Kidney cells instead.

FDA didn't like that, the Korean authority even less so.

FDA gave them a full two years of halting

Korean Govt still hasn't given them permission to continue in that country and there are now court cases.

SO WHAT HAPPENED?

Placebo.

With a capital P

Ugly?

Yes!

Now I know there are a few hundred of you that aren't going to know what really Placebo is and this post cant cover all the nuances and the stats involved, but at high level, trials are set up that are blinded and aim to test whether the drug really does work? They do this by sometimes going up against Placebo. Yes, you give a 'control' (a nice way of saying salt water, so in other words, not the active drug). But the patient doesn't know that. If the drug really is good, it should beat the Placebo group, comprehensively.

>

A successful drug needs to clearly outperform that baseline control group to prove its therapeutic value is real

How does that get measured? Through a measure called the p value. The p value is just a statistic expressed in terms of probability. It effectively assigns a probability that measures the results observed in the data and whether they could have occurred by chance.

You want that p value to be as low as possible. The std is 5%, that gets expressed as 0.05. So anything lower than 0.05 (like 0.02 or even 0.007 for example) show that there are real chances that the stats are holding up and the drug is the real reason why the patient is happy and is benefiting!

WELL...

Well what?

So what's the Good news?

Oh yes of course...

There is a naturally based molecule called Pentosan that I've been following and it's looking really ace.

• Good Efficacy against OA so far in terms of both symptomatic and structural benefits
• Very broad efficacy in the way it works
• Supreme Safety Record
• Low dose and NOT continuous dosing required!
• SubQ so it is systemic (not intra-articular)
• Not addictive.
• Great duration

Yeah but Mozz, it's prob a half light year away right?

Nope, in two months or so we should have the Interim Result in their current Globally Harmonised Phase III and this time next year (kinda to the exact day) all participants will be done (Day 404). Yes it will take some time to compile the mass data and organise an NDA...

WHAT HAPPENED TO KOLON'S TG-C - CAN IT HAPPEN TO SUB Q PENTOSAN?

Well yes, theoretically it can. However, so far in their Phase 2 B trials and a number of other studies and observations the one thing that Pentosan is, is consistent. Is that enough? No, but it helps. But it's a good step ahead of the rest. And there are many that haven't worked so far. Kolon being the latest one.

https://preview.redd.it/i1hsg32zjqeh1.png?width=230&format=png&auto=webp&s=06a3c84be44d4ddbeeb60fdad1eeb717dfd977e1

At any rate we don't have long to wait, if it is a mere 'PASS' at interim, we will be allowed to GO on to continue this exciting trial and hopefully have a successful drug that actually and finally addresses OA!

Bring on September's results.

- Mozz

.

DISCLAIMER: I own Paradigm Shares. I am not paid by the company and do not work for or in the Pharma industry.

A number have asked me over the last few weeks, Mozz, what's next for this Aussie BioPharma play?

Paradigm Biopharma recently (June 13th) announced they have commenced dosing the very last patient (out of some 538) in their Globally Harmonised Phase III.

Yeah this isn't a model that's in tandem...it's parallel. What I mean by that is that they get Registration in one market (like the USA) and they have the simultaneous ability to register in multiple markets in the one hit, examples include:

Aus

UK

Europe

Canada

In Tandem or in Parallel? Mate, we want to hit more markets at once! A big bang for our buck with less waiting around!

It's so much easier to park and maneuver when we are parallel, rather than wait for one authority to approve us and then the next and the next...

Now a lot of your reading this won't know a lot about Paradigm's main naturally based drug, Pentosan. It would actually take me a number of posts to go through it even at a higher level. I've done a fair few of these such posts in the past if you have the time and ability to traverse through those.

But tonight, all I want to do, at quite a high level, is show you and take you through the next few larger milestones and roughly when they are due.

DISCLAIMERS

Usual Disclaimers first:

A) I'm no Soothsayer, the below Timetable and associated notes are completely my own thoughts. They could not only vary somewhat from the inevitable, but they may not transpire in either the said order or completely at all!

B) This may or may not be a definitive list

C) Correspondence can be entered into (by you posting some feedback or your thoughts!) but do it professionally, don't shoot the said messenger

D) Always a great idea to build in some extra fat, I've built in a little but prob not enough, especially with the Readouts later on. It's prudent to add in a week or three here and there just in case, so we ain't disappointed with any unforeseen delays!

E) DYOR of course

THE TIMETABLE

So here it is with my notes below:

https://preview.redd.it/93n3ya7t57ch1.png?width=1615&format=png&auto=webp&s=69c7de3409dafc3a0b04a5bb117b8dffffc2c77a

MOZZ NOTES

STAR RATING
I've come up with a rough star rating, stars in terms of impact overall, but it's also interest generating and perhaps a rough guide to how any interested parties will view the embedded data? What is the potential impact?

Max is 5 stars.

1. MRI PEER REVIEW

The MRI Peer Review based on 008 data, will be the first cab off the rank. It's a little hard to say when exactly it will drop, it technically could be even slightly earlier than the end of July but maybe realistically, with a bit of to'ing and fro'ing, it will be early to mid Aug?

It's a solid three star rating. It will be a terrific read. It doesn't make a higher star cut because it is based on a Phase 2 with lower numbers (n) but at the same time it is our very exciting Structural clues that are reviewed by our Peers! I take it as a prelude for the all important major milestone to come, see point 5 below!

2. INTERIM ANALYSIS

It's potential a major inflection point. It's not merely a do we continue or don't we, there will be at least some chance of what is known as 'Early Conclusion'. Meaning the data is so good at this half way point that it becomes a major talking point and a point where PAR may score their very first major distribution deal if the data is stellar-like!

Again, a little hard to pinpoint exactly when IA will actually drop...I've given it a wider birth of 3 weeks sometime in Sept. Part of me yearns for it to be 1st week Sept...but realistically, later is prob a higher chance (ie. Week 3 or 4 Sept, maybe even a tiny slip into the very start of Oct?). It takes a while to compile all the data, a lot of it is first time used for Paradigm, eg ADP and the App! This App also contains a patient diary (E-Diary) so this will also, no doubt, add at least some overhead in terms of getting the data, analysis and then producing the final report...

It rates as a solid 4 star for me. It could definitely have the propensity to move our share price, to move us solidly into deal territory. I'm holding off here on a fifth star to incorporate some wriggle room for a Drug Effect Size that is still quite awesome but it results in a pass and please continue. We will prob get that regardless but it's the gears that might turn in the background that could make all the difference to us and our share price at the time!

Gee Mozz, how many gears are there in the background?

Not long to wait for this (potentially) magnificent major milestone!

3. OPTIONS EXERCISE

Now you will see that I have only given it a one star rating here. It's not that I don't think it is not important or not exciting, I long to get these babies exercised. We will only have 20 business days to do it from IA announcement. It will be exciting but I kinda view the actual mechanics of it as, well...mechanical! The real fun for me are the darling Gold Piggies...

Yeah, now thats what I'm talking about...

So don't be fooled by the lone 1 star...that could grow to a complete set of stars by early 2029. So much time to be right on those Piggy Back options? I love it.

New to PAR and Mozz? Well don't be sad you missed out on the free options granted in the last SPP recently. You can buy them on market and they are still at a bargain basement price, you could pick them up for as little as 8 cents tomorrow! (not advice!). Yes they are two stage, exercise those if they go into the money (or even just out of the money) and you get a free Piggy Back that has an expiry date of....... wait for it....

April....

No! Not April 2027...

...

...not even 2028....

(huh?!)

.

...it's April 2029!

.

What's the strike on that??? $2? $1?

.

Mate, it's 38 .....cents!

.

4. 100% PRIMARY READ OUT

Now we are getting to the Business end of town...

In me Mozz books, this is the Big one. Sure, Interim duly lights the fire...but it's the 100% Primary that should be the Fireworks.

The FDA themselves puts more credence in the 100% of the cohorts reaching Day 112.

Why?

Because the entire Registrational Phase III trial that we are in the midst of, is designed and powered for all of the 538 patients getting to the Primary Readout. The Interim is a mere Peek! Sure the Peek could be good, could be excellent...but it's the data for 100% of the trial that is the true essence of the study. This is what the FDA waits for.

At this point in time, there will be a lot of data and that announcement could be quite an announcement.

What could we expect at this juncture?

• Physical Function: Measured via WOMAC sub-scores or similar validated scales to show that pain reduction actually translates to better mobility.
• Patient Global Assessment (PGA): The patients' overall self-reported impression of change/improvement.
• Responder Outcomes: The percentage of patients who achieved a clinically meaningful threshold of improvement (e.g., a > 30% or > 50% reduction in pain).
• Safety & Tolerability Data: A summary of Adverse Events (AEs) to confirm the safety profile holds up across the full 538-patient cohort.

That's some heavy hitters right there, I'm -so- dying to see PGIC p value with n at around 500. It will be nuttily small.

Oh gosh darn it, I can't resist, here is a gentle recap (I say "darn it" cos I have to go look up these data points on the fly....give me a sec)...

*Incidental background Music plays unobtrusively*...

Helllllllooo , take a read of this, this in our 005 (Phase II B study):

https://preview.redd.it/pf295v3967ch1.png?width=1533&format=png&auto=webp&s=e38b0af1668984801d3357bae77eb5147ab171c3

Can you just imagine what that Red arrow is pointing to?

Mozz, It's a low number, what does it mean...?

It means that there is only a mere 0.62 of ONE Percent chance that it is due to absolute randominity that the patient is getting benefit. In other words (We call it Mozz® Speak), the drug works. It's enough for the FDA, it's enough for me...it's enough for you...and realistically, it's prob good for the Illinois Police Dept.?

In 008, the PGIC p value computed out to be 0.01.

Don't be fooled, do remember n was circa 56 in 005 (Active cohort) and ONLY about 20 in 008. (So in other words, 0.01 in our Synovial {008} study was a great result again).

Why I get goosebumps thinking about PGIC is two fold:

A) The FDA loves PGIC as a measure, it's RWE. (Real World Evidence).
B) Mate, the stats are nutty, you increase n to some 250 like what we will have in our current P3...hold Drug Effect Size constant, p gets simply crushed, I have to run a few more stats models but according to me, something in the order of p < 0.0001 is highly plausible.

It's a solid 5 stars from me. I'm calling it week 2 Jan, 2027 but I won't be disappointed if it is week 4 Jan for instance. It is worth the wait!

.

5. DAY 168 TOP LINE

This is the mother of all readouts. This will change our Company absolutely.

It is at this very read out we will no longer be merely a GOOD Pain and Function Company. We will be a Disease Modifier. If the data is at all consistent with what early signs we saw in the amazing 008 study.

It is at this point I will be on the edge of me seat looking for those p values on BMELs
On OSTEOPHYTES
ON CARTILAGE VOLUME...and how it compares with Placebo.

This is, for me, a super Blockbuster in the making.

Get decent p values here and we are so done (in a good way).

It all potentially changes at this point. PAR, I can only hope you one day read this, but if you get crushing p values here, we longer termers will ALL just lift you and exalt you all up.

I would give it 6 stars if it would fit in me excel spreadsheet up there.

This is very the moment I have been waiting for some 10 straight years. The scientific and statistical verification. PAR, take that to the USA and Europe and auction^(*) the darn thing.

*= Auction doesn't mean sell the Company! It just means get a Distribution Partnership

We keep the rights
We are the middle person, no ways around it
We have the relationship with bene, our beloved pals and partner.
We oversee the new Distribution (BP) Partner
We keep this listed as a proud ASX company (maybe dual listed one day, but domiciled here in Australia).

.

6. OARSI 2027

Ahhh well this one is a personal fave. It will be my 5th Oarsi, this one in Barcelona. I do very much enjoy attending these scientific conferences to discuss all that is OsteoArthritis. Yes that's the principal first disease Paradigm is addressing, but it isn't the ONLY indication, there are potentially many.

Interested in more about OARSI ?

Follow these links for more info:

https://hotcopper.com.au/threads/oarsi-2026.9038582/page-42?post_id=83887158

https://hotcopper.com.au/threads/oarsi-2026.9038582/page-45?post_id=83973791

https://hotcopper.com.au/threads/oarsi-2026.9038582/page-50?post_id=84057671

So that ends my little play at the timetable, it might be off a bit...but it's my personal opinions.

Let's indeed see how it plays out, the good news here is that all of the above are the Reg and Clinical Milestones and they all fall within just 12 months from today!

Commercially? Well let's just see how that plays out! Horse before Cart... get the Clinical milestones done, the rest will follow.

.

I have been waiting patiently...we ain't too far away now!

.

Mozz

.

Not advice, PAR deemed to be a speculative stock, though I like what I see.

A number have asked me over the last few weeks, Mozz, what's next for this Aussie BioPharma play?

Paradigm Biopharma recently (June 13th) announced they have commenced dosing the very last patient (out of some 538) in their Globally Harmonised Phase III.

Yeah this isn't a model that's in tandem...it's parallel. What I mean by that is that they get Registration in one market (like the USA) and they have the simultaneous ability to register in multiple markets in the one hit, examples include:

Aus

UK

Europe

Canada

In Tandem or in Parallel? Mate, we want to hit more markets at once! A big bang for our buck with less waiting around!

It's so much easier to park and maneuver when we are parallel, rather than wait for one authority to approve us and then the next and the next...

Now a lot of your reading this won't know a lot about Paradigm's main naturally based drug, Pentosan. It would actually take me a number of posts to go through it even at a higher level. I've done a fair few of these such posts in the past if you have the time and ability to traverse through those.

But tonight, all I want to do, at quite a high level, is show you and take you through the next few larger milestones and roughly when they are due.

DISCLAIMERS

Usual Disclaimers first:

A) I'm no Soothsayer, the below Timetable and associated notes are completely my own thoughts. They could not only vary somewhat from the inevitable, but they may not transpire in either the said order or completely at all!

B) This may or may not be a definitive list

C) Correspondence can be entered into (by you posting some feedback or your thoughts!) but do it professionally, don't shoot the said messenger

D) Always a great idea to build in some extra fat, I've built in a little but prob not enough, especially with the Readouts later on. It's prudent to add in a week or three here and there just in case, so we ain't disappointed with any unforeseen delays!

E) DYOR of course

THE TIMETABLE

So here it is with my notes below:

https://preview.redd.it/93n3ya7t57ch1.png?width=1615&format=png&auto=webp&s=69c7de3409dafc3a0b04a5bb117b8dffffc2c77a

MOZZ NOTES

STAR RATING
I've come up with a rough star rating, stars in terms of impact overall, but it's also interest generating and perhaps a rough guide to how any interested parties will view the embedded data? What is the potential impact?

Max is 5 stars.

1. MRI PEER REVIEW

The MRI Peer Review based on 008 data, will be the first cab off the rank. It's a little hard to say when exactly it will drop, it technically could be even slightly earlier than the end of July but maybe realistically, with a bit of to'ing and fro'ing, it will be early to mid Aug?

It's a solid three star rating. It will be a terrific read. It doesn't make a higher star cut because it is based on a Phase 2 with lower numbers (n) but at the same time it is our very exciting Structural clues that are reviewed by our Peers! I take it as a prelude for the all important major milestone to come, see point 5 below!

2. INTERIM ANALYSIS

It's potential a major inflection point. It's not merely a do we continue or don't we, there will be at least some chance of what is known as 'Early Conclusion'. Meaning the data is so good at this half way point that it becomes a major talking point and a point where PAR may score their very first major distribution deal if the data is stellar-like!

Again, a little hard to pinpoint exactly when IA will actually drop...I've given it a wider birth of 3 weeks sometime in Sept. Part of me yearns for it to be 1st week Sept...but realistically, later is prob a higher chance (ie. Week 3 or 4 Sept, maybe even a tiny slip into the very start of Oct?). It takes a while to compile all the data, a lot of it is first time used for Paradigm, eg ADP and the App! This App also contains a patient diary (E-Diary) so this will also, no doubt, add at least some overhead in terms of getting the data, analysis and then producing the final report...

It rates as a solid 4 star for me. It could definitely have the propensity to move our share price, to move us solidly into deal territory. I'm holding off here on a fifth star to incorporate some wriggle room for a Drug Effect Size that is still quite awesome but it results in a pass and please continue. We will prob get that regardless but it's the gears that might turn in the background that could make all the difference to us and our share price at the time!

Gee Mozz, how many gears are there in the background?

Not long to wait for this (potentially) magnificent major milestone!

3. OPTIONS EXERCISE

Now you will see that I have only given it a one star rating here. It's not that I don't think it is not important or not exciting, I long to get these babies exercised. We will only have 20 business days to do it from IA announcement. It will be exciting but I kinda view the actual mechanics of it as, well...mechanical! The real fun for me are the darling Gold Piggies...

Yeah, now thats what I'm talking about...

So don't be fooled by the lone 1 star...that could grow to a complete set of stars by early 2029. So much time to be right on those Piggy Back options? I love it.

New to PAR and Mozz? Well don't be sad you missed out on the free options granted in the last SPP recently. You can buy them on market and they are still at a bargain basement price, you could pick them up for as little as 8 cents tomorrow! (not advice!). Yes they are two stage, exercise those if they go into the money (or even just out of the money) and you get a free Piggy Back that has an expiry date of....... wait for it....

April....

No! Not Jan 2027...

not even 2028....

(huh?!)

.

...it's 2029!

What's the strike on that??? $2? $1?

.

Mate, it's 38 .....cents!

4. 100% PRIMARY READ OUT

Now we are getting to the Business end of town...

In me Mozz books, this is the Big one. Sure, Interim duly lights the fire...but it's the 100% Primary that should be the Fireworks.

The FDA themselves puts more credence in the 100% of the cohorts reaching Day 112.

Why?

Because the entire Registrational Phase III trial that we are in the midst of, is designed and powered for all of the 538 patients getting to the Primary Readout. The Interim is a mere Peek! Sure the Peek could be good, could be excellent...but it's the data for 100% of the trial that is the true essence of the study. This is what the FDA waits for.

At this point in time, there will be a lot of data and that announcement could be quite an announcement.

What could we expect at this juncture?

• Physical Function: Measured via WOMAC sub-scores or similar validated scales to show that pain reduction actually translates to better mobility.
• Patient Global Assessment (PGA): The patients' overall self-reported impression of change/improvement.
• Responder Outcomes: The percentage of patients who achieved a clinically meaningful threshold of improvement (e.g., a > 30% or > 50% reduction in pain).
• Safety & Tolerability Data: A summary of Adverse Events (AEs) to confirm the safety profile holds up across the full 538-patient cohort.

That's some heavy hitters right there, I'm -so- dying to see PGIC p value with n at around 500. It will be nuttily small.

Oh gosh darn it, I can't resist, here is a gentle recap (I say "darn it" cos I have to go look up these data points on the fly....give me a sec)...

*Incidental background Music plays unobtrusively*...

Helllllllooo , take a read of this, this in our 005 (Phase II B study):

https://preview.redd.it/pf295v3967ch1.png?width=1533&format=png&auto=webp&s=e38b0af1668984801d3357bae77eb5147ab171c3

Can you just imagine what that Red arrow is pointing to?

Mozz, It's a low number, what does it mean...?

It means that there is only a mere 0.62 of ONE Percent chance that it is due to absolute randominity that the patient is getting benefit. In other words (We call it Mozz® Speak), the drug works. It's enough for the FDA, it's enough for me...it's enough for you...and realistically, it's prob good for the Illinois Police Dept.?

In 008, the PGIC p value computed out to be 0.01.

Don't be fooled, do remember n was circa 56 in 005 (Active cohort) and ONLY about 20 in 008. (So in other words, 0.01 in our Synovial {008} study was a great result again).

Why I get goosebumps thinking about PGIC is two fold:

A) The FDA loves PGIC as a measure, it's RWE. (Real World Evidence).
B) Mate, the stats are nutty, you increase n to some 250 like what we will have in our current P3...hold Drug Effect Size constant, p gets simply crushed, I have to run a few more stats models but according to me, something in the order of p < 0.0001 is highly plausible.

It's a solid 5 stars from me. I'm calling it week 2 Jan, 2027 but I won't be disappointed if it is week 4 Jan for instance. It is worth the wait!

5. DAY 168 TOP LINE

This is the mother of all readouts. This will change our Company absolutely.

It is at this very read out we will no longer be merely a GOOD Pain and Function Company. We will be a Disease Modifier. If the data is at all consistent with what early signs we saw in the amazing 008 study.

It is at this point I will be on the edge of me seat looking for those p values on BMELs
On OSTEOPHYTES
ON CARTILAGE VOLUME...and how it compares with Placebo.

This is, for me, a super Blockbuster in the making.

Get decent p values here and we are so done (in a good way).

It all potentially changes at this point. PAR, I can only hope you one day read this, but if you get crushing p values here, we longer termers will ALL just lift you and exalt you all up.

I would give it 6 stars if it would fit in me excel spreadsheet up there.

This is very the moment I have been waiting for some 10 straight years. The scientific and statistical verification. PAR, take that to the USA and Europe and auction^(*) the darn thing.

*= Auction doesn't mean sell the Company! It just means get a Distribution Partnership

We keep the rights
We are the middle person, no ways around it
We have the relationship with bene, our beloved pals and partner.
We oversee the new Distribution (BP) Partner
We keep this listed as a proud ASX company (maybe dual listed one day, but domiciled here in Australia).

6. OARSI 2027

Ahhh well this one is a personal fave. It will be my 5th Oarsi, this one in Barcelona. I do very much attending these scientific conferences to discuss all that is OsteoArthritis. Yes that's the principal first disease Paradigm is addressing, but it isn't the ONLY indication, there are potentially many.

Interested in more about OARSI and some of my learnings?

Follow these links for more info:

https://hotcopper.com.au/threads/oarsi-2026.9038582/page-42?post_id=83887158

https://hotcopper.com.au/threads/oarsi-2026.9038582/page-45?post_id=83973791

https://hotcopper.com.au/threads/oarsi-2026.9038582/page-50?post_id=84057671

So that ends my little play at the timetable, it might be off a bit...but it's my personal opinions.

Let's indeed see how it plays out, the good news here is that all of the above are the Reg and Clinical Milestones and they all fall within just 12 months from today!

Commercially? Well let's just see how that plays out! Horse before Cart... get the Clinical milestones done, the rest will follow.

I have been waiting patiently...we ain't too far away now!

Mozz

.

Not advice, PAR deemed to be a speculative stock, though I like what I see.

PARADIGM BIO - Enrolment complete!

Paradigm Bio of Australia (PAR.AX) today announced that the very last patient in their Phase three trial for Osteoarthritis (OA), has had their first dose.

What does that mean? Well a Phase 3 is the last clinical trial you need to have to show your drug works and how it works up against some competition or a Placebo. (There can be the requirement of Phase 4 studies but that's usually AFTER the drug has been licensed).

There were supposed to be 466 patients enrolled but this has climbed to 538. Is that good or bad? Well it's very good as it means the trial is even more powered to show a positive effect!

It was already decently powered, this should ensure the results are even better at a few time points after the Interim Analysis (IA) Result. We'll get to the IA in a sec.

So Par have achieved steadfast recruitment rates AND have more patients to glean data from. They have also recently passed the first Regulatory test which was the 20% stage conducted by the Data Safety Review Board, it was a green flag there...

No Safety Issues, please continue!

Go go go...

WHAT'S NEXT

So now the dosing phase is just about done and we enter the monitoring phase...The IA readout occurs when 50% of the two cohorts (Placebo and Active) make it to day 112. This is slated to occur roughly mid September. It will be the biggest test to see how the drug is performing.

If it's merely a Pass, that's enough. But if the results are as good as they were in the Phase two trial (008 program), we could get a significant first time distribution deal. That's what I would call time for a share price re-rate. By my humble calcs, being a Phase three genuine candidate for a drug that's showing a stack of promise in terms of:

• Pain reduction
• Function Improvement
• Stiffness reduction
• Duration
• Safety
• Structural positive sightings (think BMEL, Osteophytes, Improved Joint Space Width potential, improved cartilage volume growth and better joint health)

Well, we are onto something!

It is one thing to show pain and function improvements, quite another to show structural modifications, that's called DMOAD, Disease Modification Osteo Arthritis Drug. There is currently no such thing, PAR is hoping to be the first... Globally.

INTERIM READOUT

So the Interim readout is when 50% of the patients hit Day 112. At that stage there is a top line readout on how the Active is looking against Placebo. It's at this stage we as investors will know if there are merits of the drug at scale. Think of it like a top level sneak peek!

Sneak peek?

Don't forget, the IA readout is just 14 weeks away. Yeah, worth the wait!

14 weeks - c'mon!

I will have a post after a couple of months documenting what we need at Interim and why exactly I'm confident on the result.

INVITE

Want to know more? Well how about a webinar invite, this Thursday 18 June at 11am AEST, here is the link for registration, yes there will be a Q & A section at the end:

https://investors.paradigmbiopharma.com/webinars/PBJ3VP-phase-3-trial-update

.

Do your own research - no advice contained in this post.

Paradigm Bio of Australia (PAR.AX) today announced that the very last patient in their Phase three trial for Osteoarthritis (OA), has had their first dose.

What does that mean? Well a Phase 3 is the last clinical trial you need to have to show your drug works and how it works up against some competition or a Placebo. (There can be the requirement of Phase 4 studies but that's usually AFTER the drug has been licensed).

There were supposed to be 466 patients enrolled but this has climbed to 538. Is that good or bad? Well it's very good as it means the trial is even more powered to show a positive effect!

It was already decently powered, this should ensure the results are even better at a few time points after the Interim Analysis (IA) Result. We'll get to the IA in a sec.

So Par have achieved steadfast recruitment rates AND have more patients to glean data from. They have also recently passed the first Regulatory test which was the 20% stage conducted by the Data Safety Review Board, it was a green flag there...

No Safety Issues, please continue!

Go go go...

WHAT'S NEXT

So now the dosing phase is just about done and we enter the monitoring phase...The IA readout occurs when 50% of the two cohorts (Placebo and Active) make it to day 112. This is slated to occur roughly mid September. It will be the biggest test to see how the drug is performing.

If it's merely a Pass, that's enough. But if the results are as good as they were in the Phase two trial (008 program), we could get a significant first time distribution deal. That's what I would call time for a share price re-rate. By my humble calcs, being a Phase three genuine candidate for a drug that's showing a stack of promise in terms of:

• Pain reduction
• Function Improvement
• Stiffness reduction
• Duration
• Safety
• Structural positive sightings (think BMEL, Osteophytes, Improved Joint Space Width potential, improved cartilage volume growth and better joint health)

Well, we are onto something!

It is one thing to show pain and function improvements, quite another to show structural modifications, that's called DMOAD, Disease Modification Osteo Arthritis Drug. There is currently no such thing, PAR is hoping to be the first... Globally.

INTERIM READOUT

So the Interim readout is when 50% of the patients hit Day 112. At that stage there is a top line readout on how the Active is looking against Placebo. It's at this stage we as investors will know if there are merits of the drug at scale. Think of it like a top level sneak peek!

Sneak peek?

Don't forget, the IA readout is just 14 weeks away. Yeah, worth the wait!

14 weeks - c'mon!

I will have a post after a couple of months documenting what we need at Interim and why exactly I'm confident on the result.

INVITE

Want to know more? Well how about a webinar invite, this Thursday 18 June at 11am AEST, here is the link for registration, yes there will be a Q & A section at the end:

https://investors.paradigmbiopharma.com/webinars/PBJ3VP-phase-3-trial-update

.

Do your own research - no advice contained in this post.

I've been following 4DX since it was 12 cents a share...gee that seems like an eon ago but it wasn't even a year in the past! That's how much the story has leapfrogged since then!

They are going from strength to strength...from garnering Research Hospitals in the US to slowly expanding in Europe. Yes their latest ann was Europe. It's an enormous gateway...

But wait Mozz, if it's so good, explain to me this, how does it go from 12 cents way up to $7 plus and then down to the $3's...(though its swimming hard and nearly $4 now?

Err...Shouldn't it just go up?

Yep, that's cos it joined the Index.

Huh?

So it joins the ASX200 index and it goes down???

How does that make any sense?

THE BIG SHORT

So a stock like 4DX newly joins a large and prestigious index and the stock goes DOWN!?

Yep...so profit takers knew about the prospects of it making into the 200 club and before this official ann. they buy...once the news breaks, they sell.

Why?

Well they sell to crystallise their profit as they already made their money and are ready to move on. But you know what, that's not all that's going on. Shorters. Yeah the ugly shorters...they also know that larger Index tracking funds are mandated to buy in now that the stock has made into into Club 200...and they have to add the stock. 4DX are doing well but dividends are still off the scope for a while yet...so how does an index tracking fund earn money on a stock that's slated to go sideways, maybe even downwards for a bit?

Welcome to the exclusive ASX 200 Club sir...

They rent it out! Imagine I was wealthy enough to own a boat (I'm not and to be honest, if I ever was, I wouldn't buy one, I would hire one when (if) i ever needed one!). (Yes of course with staff..who wants to do the dishes and mop the deck on a boat).

Let's go? err...think it's a tad out of the budget Mozz!

It's the same thing with the shares, these big wigs lend them out while they wait for sunnier days. They lend them to shorteres for a price, who then sell them...and put pressure on the stock hoping it goes DOWN...If it goes down, they simply buy them back when they are much cheaper, return them to the lender and both parties are happy!

Mozz, we need proof of this theory. Does this really happen? Did it really happen?

It's happening as we speak:

Recent shorting action on 4DX

That chart above is over 12 months, can you just take a look at the percentage increase of shorts in just the last 3 months?

THE FUTURE

So where to from here? Well it's beyond the scope of this post for a full future prognosis, but for the uninitiated, 4DX has some you-beaut potential. Why? Three major reason that I just ♥love♥.

1. It's oh so super disruptive and offers not just a static one image shot of the lungs...it is dynamic and has multiple shots over time. That's the 4D bit. How are those lungs performing in terms of air flow and blood flow over time to highlight the areas of concern which are often missed in just a single shot! It's also in full colour with varying shades illuminating areas of concern for the Pulmonary Surgeons. If there is a tech that can help them help me, well I'm all in.

https://preview.redd.it/q7ud002zrn5h1.png?width=299&format=png&auto=webp&s=d0d76f1b5125cb0e5978773acfd4d4d5685e9128

2. Mate, it avoids contrasting chemicals. Who wants to ingest a dye so it can show up on some Computer Tomography device. Forget about me lung problem, why subject your kidneys to having to filter this crap out?

3. Nuclear medicine? It's a hard pass from me. In the past they wanted me to breath in some irradiated gas so they can track it as it passes through the lung? No thanks! 4DX has no nuclear assisted diagnostics and is totally safe and totally disruptive.

It's a buy from me, the future looks good for this one!

.

Not advice. I am not licensed.

Please conduct your own research before investing.

I just got back from Oarsi 2026.

https://preview.redd.it/rkrk2ta6u63h1.png?width=1901&format=png&auto=webp&s=363bc58bbb1bb03cf66665ccd3fb2bd893767f7f

What is that? It is known as Osteo Arthritis Research Society International.

It's a global scientific conference with approx 900 attendees that discusses OA and presents research on possible new drugs and modalities that can assist in terms of OA related conditions.

There are three main drugs that are on my radar. I'm not really looking too heavily at emerging solutions ie Preclinical models or even Phase 1 results. I'm more looking at the more shorter term potential candidates. I am following three and one of them more closely than the other two. Let's cover them at a high level:

1) KOLON TISSUE GENE - South Korea

Invossa

WHAT

Gene Therapy

HOW

Cell Mediated Gene Therapy, 3:1 Mix of Human cartilage cells and genetically modified cells to express TGF-B1 protein.

PROS

Quite effective, no longer term Serious AE's so far.

CONS

Gene Therapy might have longer term consequences, though none have been found with Invossa in last few years.

Company has had some mis steps in the past including incorrect sourcing of donor cells, though it sounds like they have rectified these now.

Expensive

Must be stored in very cold super freezers and can't be administered by just any nurse.

Intra Articular

2) LEVICEPT - Uk

Levi04

WHAT

Is a protein that targets neurotrophin-3 activity.

HOW

This protein assists to 'soak' up these neurotrophins before they hit pain receptors and assists in supporting beneficial effects required for joint remodelling.

PROS

Pain relief is efficacious

Possible positive structural modification

2 Year Durational readout due in circa one month.

CONS

Phase 2 was IV format, they are working on adapting their P3 for a SubQ delivery.

There can be some patients that develop anti-drug antibodies as Levi-04 is a biological fusion protein.

Need time to re-formulate and then prob do some toxicology/bridging-repurposing studies and then they start a 2 year Phase 3 program.

3) PARADIGM - Australia

iPPS - Zilosul

WHAT

It's a natural sugar based semi synthetic repurposed drug, known as Pentosan Polysulfate Sodium. Currently used for Interstitial Cystitis in pill format.

HOW

Through a multi modal series of actions eg Mild Blood thinner, Anti Inflammatory by downregulation (not blocking) of Ngf, NfKB and other inflammatory cytokines. Offers chondroprotection via stimulation of increase HWHA. Improves workings of chondrocytes and improves extracellular matrix.

PROS

Approaches the disease of OA holistically.

Excellent safety record in SubQ format and has some 70 plus years of safety with Pill and injectable format.

Only a 6 week course of SubQ and then most patients need no booster for 12 to 18 months

Not Intraarticular, so works systemically on ALL joints at once.

Good evidence of Bone Marrow Edema regression and Cartilage Volume Growth in their Phase 2 compared to Placebo, now needs to be seen at scale (phase 3).

Currently in Globally harmonised P3. First Interim Readout due in 15 weeks.

Stable at room temperature, shelf life approx 2 years.

Relatively inexpensive

CONS

Mild blood thinner

Maculopathy warnings in Pill format over decades of high use (should be largely avoidable with SubQ format as it is very low and infrequent dosing).

.

.

---------------------

Disclaimer: These are only the three main candidates on my radar, there could be others that have some good potential but I don't see any that are imminent (Phase three read outs etc). Do your own research, do not rely on only one poster/source.

No advice contained in this post.

Disclosure: I own Paradigm shares though I am not affiliated or work for the company. I independently research OA casually and work full time in the IT industry.

I follow a stock quite closely, Paradigm of Australia (PAR listed on ASX), but it's not for the faint hearted. They have had some ups and downs and if you take a look at the current share price, well put it this way, it certainly is not a sexy looking chart!

Appetite for a layered risk proposition?

But here is where I think there is some real potential if you have at least some appetite for risk! What are we inching closer to and what is all this layering talk about?

Let's investigate.

CLOSER

So in a given set of trials, there are usually 4 major phases to complete.

Pre clinical - a very basic study, usually animal model, to ensure the drug to be tested is safe in our furry friends.

Check ✓

Phase 1 - A basic study to ensure there is no major toxicity and the results can translate into humans, usually small numbers to be prudent.

Check ✓

Phase 2 - Right this is where it not only gets interesting but it gets filtering! What I mean is that there are a lot of candidates that get eliminated right about here, as the drug not only has to work it has to either beat the competition out there OR it has to beat Placebo, that's particularly harder to do when we are dealing with pain.

That's what Paradigm of Australia (PAR) has achieved so far

Check ✓

Phase 3 - Get through Phase 2 successfully and you have beaten a lot of the crowd, in fact there aren't a lot of Aussie plays that have made it to a Phase 3 in the last 20 years and I'm including ANY indication, let alone Osteoarthritis (OA).

Hint: there are NO safe current OA drugs that address both symptomatic AND structural phenotypes! Some 630 million people have OA, its quite probable YOU will know someone that has OA, at least to some degreee!

So PAR has not only started their Globally Harmonised Phase 3...about a month and a half ago they announced they are 50% dosed through both cohorts (Placebo and Active). Im expecting the 100% dosing milestone to be announced in a month or two max. Once that is done, there is no more dosing, just monitoring.

I'm hoping for two stellar pieces of info after that:

1. Durational effect of the drug out to Day 404
2. Positive structural reversions and rescinding of the disease in a decent number of Active cohort patients.

Show both of those against Placebo and this is no more a 17 cent stock...it will be multiples of that currently disconnected price per share!!

Check ✓✓✓

LAYERING

So let's chat about layering. What do we as shareholders want? We want a large runway...we want a lot of growth potential and we want to address a large market with a good product!

Give me a large plane sure, but give me a larger potential revenue runway!

We want the larger potential for high levels of growth with only a low risk of absolute failure of course.

So we need to wait for the pivotal moment where we become de-risked. This occurs at an Interim point which is when 50% of the entire cohort reach Day 112 in this Phase 3 trial. The full trial goes to Day 404, but it is at Day 112 they do an assessment to see if the drug is working and if there is a material difference between the Placebo group and the Active group. Show this, and the result of the trial becomes de risked overnight. There is NO more dosing at this point. The dosing comprises of a SubQ administration that spans just 42 days. After that, there is no need for any more dosing for an entire 12 to 18 months, such is the potential of duration of effect!

But the layering really comes in additional, future indications.

Layered minerals? Layered potential...

I'm talking about other inflammatory conditions such as ARDS, Psoriasis, Ross River Fever and even the majors like Heart Failure by Preserved Ejection Fraction and yes, even Cholesterol and Diabetes.

Note, Half the world's Heart failures have NO solution, no beta blockers, no statins that can assist...only Pentosan in a preclinical has shown efficacy by dropping levels of ADAMTS-4 in the heart walls...I'm going to do a post on this over at Hot Copper in the near future. I'll include a link for my other posts at the very bottom of this post for any that want to know more about pentosan and the potential prospects of what could very well be one of the best performing stocks all time and certainly my best pick ever! (Speculative statement, subject to trial performance, there is still risk!).

Sure, these additional layered indications are well into the future before trials are even set up, but one day...for the longer term minded holder, this could be real incremental layered revenue play. One for the bottom drawer?

But not everything is in the long term distant future. A new recent deal^(2) with a company known as AVet could see revenue in as little as a year and a half in the veterinary space. Pentosan is already being used here in Aus in the vet space by other companies but Par could end up with the exclusive rights to a combo known as Pentacoxib^(3). Formulation work is being conducted as we speak and an animal trial would follow soon.

THE OA PROGRAM

So whats next? Well the Interim read-out is scheduled for mid September.

It is at this point we will get to see top line data on Pain. It's not till later in the study we could see some of the best data replicated that we have already seen in their Phase 2. Here is a glimpse of data^(1) in their P2:

https://preview.redd.it/omalhkcnkv1h1.png?width=1316&format=png&auto=webp&s=9a632037fc0678c980b6da8c4291bea20a7111b9

They achieved beautiful data in terms of pain too with some 65% of patients attaining better than 60% pain relief. Even the strong but risky opioids show only circa 25 to 30% reduction in pain and they as we all know, come at quite a cost!

Following the Interim readout in circa Sept this year, PAR could have a real pivot if the data is excellent. After that, a Regional Deal is possible offering Paradigm her first Commercial Validation. But it doesn't end there, top line read outs like 100% on their Primary and the all important Day 168 MRI's could also spark a real interest in this sleepy, potentially layered play.

Watch this space, it may not be a sleeper for too much longer.

...

No advice contained in this post. Par deemed to be a speculative stock listed on the ASX.

PS: Hungry for more? Check out my previous posts if you want to know more or DM/comment.

REFERENCES USED:

1. https://investors.paradigmbiopharma.com/announcements/7512669?fromLink=true&
2. https://investors.paradigmbiopharma.com/announcements/7353928
3. https://investors.paradigmbiopharma.com/announcements/7023922

I follow a stock quite closely, Paradigm of Australia, but it's not for the faint hearted. They have had some ups and downs and if you take a look at the current share price, well put it this way, it certainly is not a sexy looking chart!

Appetite for a layered risk proposition?

But here is where I think there is some real potential if you have at least some appetite for risk! What are we itching close to and what is all this layering talk about?

Let's investigate.

CLOSER

So in a given set of trials, there are usually 4 major phases to complete.

Pre clinical - a very basic study, usually animal model, to ensure the drug to be tested is safe in our furry friends.

Check ✓

Phase 1 - A basic study to ensure there is no major toxicity and the results can translate into humans, usually small numbers to be prudent.

Check ✓

Phase 2 - Right this is where it not only gets interesting but it gets filtering! What I mean is that there are a lot of candidates that get eliminated right about here, as the drug not only has to work it has to either beat the competition out there OR it has to beat Placebo, that's particularly harder to do when we are dealing with pain.

That's what Paradigm of Australia (PAR) has achieved so far

Check ✓

Phase 3 - Get through Phase 2 successfully and you have beaten a lot of the crowd, in fact there aren't a lot of Aussie plays that have made it to a Phase 3 in the last 20 years and I'm including ANY indication, let alone Osteoarthritis (OA).

Hint: there are NO safe current OA drugs that address both symptomatic AND structural phenotypes!

So PAR has not only started their Globally Harmonised Phase 3...about a month and a half ago they announced they are 50% dosed through both cohorts (Placebo and Active). Im expecting the 100% dosing milestone to be announced in a month or two max. Once that is done, there is no more dosing, just monitoring.

I'm hoping for two stellar pieces of info after that:

1. Durational effect of the drug out to Day 404

2. Positive structural reversions and rescinding of the disease in a decent number of Active cohort patients.

Show both of those against Placebo and this is no more a 17 cent stock...it will be multiples of that currently disconnected price per share!!

Check ✓✓✓

LAYERING

So let's chat about layering. What do we as shareholders want? We want a large runway...we want a lot of growth potential and we want to address a large market with a good product!

Give me a large plane sure, but give me a larger potential revenue runway!

We want the larger potential for high levels of growth with only a low risk of absolute failure of course.

So we need to wait for the pivotal moment where we become de-risked. This occurs at an Interim point which is when 50% of the entire cohort reach Day 112 in this Phase 3 trial. The full trial goes to Day 404, but it is at Day 112 they do an assessment to see if the drug is working and if there is a material difference between the Placebo group and the Active group. Show this, and the result of the trial becomes de risked overnight. There is NO more dosing at this point. The dosing comprises of a SubQ administration that spans just 42 days. After that, there is no need for any more dosing for an entire 12 to 18 months, such is the potential of duration of effect!

But the layering really comes in additional, future indications.

Layered minerals? Layered potential...

I'm talking about other inflammatory conditions such as ARDS, Psoriasis, Ross River Fever and even the majors like Heart Failure by Preserved Ejection Fraction and yes, even Cholesterol and Diabetes.

Note, Half the world's Heart failures have NO solution, no beta blockers, no statins that can assist...only Pentosan in a preclinical has shown efficacy by dropping levels of ADAMTS-4 in the heart walls...I'm going to do a post on this over at Hot Copper in the near future. I'll include a link for my other posts at the very bottom of this post for any that want to know more about pentosan and the potential prospects of what could very well be one of the best performing stocks all time and certainly my best pick ever! (Speculative statement, subject to trial performance, there is still risk!).

Sure, these additional layered indications are well into the future before trials are even set up, but one day...for the longer term minded holder, this could be real incremental layered revenue play. One for the bottom drawer?

But not everything is in the long term distant future. A new recent deal^(2) with a company known as AVet could see revenue in as little as a year and a half in the veterinary space. Pentosan is already being used here in Aus in the vet space by other companies but Par could end up with the exclusive rights to a combo known as Pentacoxib^(3). Formulation work is being conducted as we speak and an animal trial would follow soon.

THE OA PROGRAM

So whats next? Well the Interim read-out is scheduled for mid September.

It is at this point we will get to see top line data on Pain. It's not till later in the study we could see some of the best data replicated that we have already seen in their Phase 2. Here is a glimpse of data^(1) in their P2:

https://preview.redd.it/omalhkcnkv1h1.png?width=1316&format=png&auto=webp&s=9a632037fc0678c980b6da8c4291bea20a7111b9

They achieved beautiful data in terms of pain too with some 65% of patients attaining better than 60% pain relief. Even the strong but risky opioids show only circa 25 to 30% reduction in pain and they as we all know, come at quite a cost!

Following the Interim readout in circa Sept this year, PAR could have a real pivot if the data is excellent. After that, a Regional Deal is possible offering Paradigm her first Commercial Validation. But it doesn't end there, top line read outs like 100% on their Primary and the all important Day 168 MRI's could also spark a real interest in this sleepy, potentially layered play.

Watch this space, it may not be a sleeper for too much longer.

No advice contained in this post. Par deemed to be a speculative stock listed on the ASX.

PS: Hungry for more? Check out this link:

https://hotcopper.com.au/threads/mozz-research-2025.8961752/?post_id=82241843

REFERENCES USED:

1. https://investors.paradigmbiopharma.com/announcements/7512669?fromLink=true&

2. https://investors.paradigmbiopharma.com/announcements/7353928

3. https://investors.paradigmbiopharma.com/announcements/7023922