onight, another comparison, I've done a couple of these in the past, it's time to do another one while we wait with increased anticipation for funding.
Please as always, do now enjoy.
INTRO
Dimerix is a bio pharma company listed on the Aus stock exchange.
What do they do? They have a targeting molecule that addresses some types of specific inflammation. Their first indication is a rare kidney disease and after that they may address COPD.
WHY THE COMPARISON?
It's always good to see what others in the health space are doing and look briefly at their journey and compare it to ours.
Hey wait a minute, what has Dimerix got to do with a former bus driver?
Well apparently the current CEO, Dr Nina Webster apparently used to be one!
HOW DOES IT WORK?
Not really part of the scope for this post but briefly, for the first indication, a rare disease indication known as FSGS, their drug, DMX-200, is a synergistic drug, ie it works with a particular Blood Pressure reduction medicine and their drug assists to reduce inflammation. Their drug works by blocking certain signalling processes.1.5 This is a combo that has been shown to be favourable against a placebo arm in a previous P2 and they are now in the midst of a P3.
How do our results stack up? Are we a commercially viable comparison?
An interesting comparison is that for our OA trial our Primary is Pain reduction, some 55% achieved greater than the minimum clinically meaningful threshold of greater than 30% reduction in pain all the way out at Day 365, with more than 70% achieving a reduction of greater than 30% at Day 56.
ABove - iPPS's results from the 008 study.
DEAL ME IN
What is in the scope of this post is the comparison to what deals have already been made with Dimerix...so, where could we be heading?
Dimerix have already completed three regional deals and they just signed up the fourth.
The latest and fourth deal they just signed was for the all important USA market.
What I wanted to know is, how does this recent USA deal compare to when ours MIGHT end up being consummated? Are we late in comparison? When is the right and favourable timing for this?
Well their USA deal came some 1 year and 3 months AFTER their Phase 3 interim (March 2024) result came out.
Their US partner is Amicus.
Deal metrics? Take a look 1:
...And what were the deals they had signed up previously?
Of course we can't just take their deal metrics and say that's what we should expect....we need to compare apples with apples...
MARKET TO MARKET
To get a sense of what those deals mean, we need to compare market to market. How does the FSGS market compare to OA?
Well it is estimated that in the USA the FSGS market is approx $585 Million USD (2022) rising to about 1 billion in 2031.2
What then is the market equivalent for OA?
Mozz Quiz time?
Of course.
IN TERMS OF SALES DOLLARS WHAT IS THE APPROXIMATE OA MARKET WORTH IN 2021 (COMPARED TO $585 M FOR FSGS)?
A) Well ...somewhat more than the FSGS market!?
B) Greater than $300 Million USD?
C) Greater than $1.75 Billion ???
If you picked A), actually even if you picked B) and C), you were right! Finally, you got it right!
The Answer?
$7.4 Billion
But thats back in 2021. The estimated figure for circa 2030 is $15.3 Billion.6 !
To give you a sense of how much that is, those deals Dimerix have struck compared to our potential, the OA market is some 14 times the size. Sure it's a rough and there are many factors that make a market in both theirs and in our case, we also are comparing a Rare disease indication to a mainstream, but at the end of the day, my point here is that we have scope...we have scale, these deals we initially strike might have a slight haircut to them, when we get to the business end of the deals (larger regions), they are going to have to pay.
There will be a distinct and irrefutable premium for the larger regions and Pharmas that they have to pay. Why? Because they are coming to the party late. They are getting a much more de-risked product (After interim for example).
THE SURPRISE ELEMENT
The CEO of Dimerix, Dr Nina Webster, stated this about deals:
"Deals get done when they get done...".
...What she infers is that these deals can happen at any time, they take their own time...they strike when they strike.
This is what we also need to say.... that same statement applies to us. PAR needs to just progress. Yes funding is critical, yes we want as little dilution as possible and dont I know it, we gotta get away from this Bell style funding...they have helped us in the past, thats it now...we need a better model going forward.
But once that's out of the way...it is Blue sky from there.
I want this.
Par hasn't given us too many surprises in the past few years apart from sterling data! (Yeah - that's quite important though!). The two that come to mind was the halting of the 008 program mid stream. I also wondered at the time of the halt was it due to some bad news? But we ended up getting an expanded program and we now know just how pivotal that program was. Do we give enough credit to PAR and Paul for this?
I don't think so. If PAR hadnt revised the program to 12 months we may not have the supreme Phase 3 protocols that have been accepted by some of the biggest Global Authorities just at the end of last year. This point will not be lost on me. Ever. The other surprise that comes to mind was the granting of Fast Track. It came from literally nowhere, without any warning.
Yes I know that PAR could've done a few things better in the past. I'm not the Ostrich burying my head in the sand.
Once we get momentum, once we get on the right funding path...there is real opportunity for POSITIVE surprises here. It could be smaller ones like new initiation of coverage as major broking houses start to detect us on their radars...it could be major surprises like Pharma deals like Dimerix are achieving. But PAR needs to emphasise these in the future roadshows and interviews. They must give us an impression that POSITIVE NEWS CAN ACTUALLY STRIKE NOW AT ANY TIME...
Give us this confidence and it won't just be the longer term cornerstone holders that will stay for the long game, you will find less trading and those with shorter terms trading views, well they may just keep a bundle or two share parcels for the medium term...the medium termers may develop into more longer termers....
The other good thing about us is that we aren't too heavily diluted and a few more shares and dilution isn't really going to make too much of a difference, specially if we end up getting more and more new indications and commercial agreements. It will be highly additive and the sellers will indeed dry up.
OPTIONS
As a further comparison to us, get this, they have options! Not only that but they expire very soon.
Let's take a look at the metrics8:
It's a pretty small raise all up. There are no Piggies involved.
Now its too early to see what the percentage uptake will be. Also note that they don't have the piggy back options, theirs are just the straight vanilla kind.
To give you a sense of how many actually take them up, we can cross to another stock for a comparison, I'll do that soon just a bit further down in this section.
So remember, for you to actually go ahead with the uptake of options be it vanilla or otherwise (Piggy back enhanced)...you, as a shareholder actually have to do something. You won't get the underlying if you are passive and do nothing.
Yeah you have to fill out a form, hand it in and PAY for the exercising of them! In the case of Dimerix, their Strike is 15.4 cents, they are currently worth 41.5 cents, that's about right, the underlying share price is $0.56, thus $0.56 - $0.154 = $0.406.
The same thing could happen for us...Yes I also think we would need more than just funding, we'd really need a regional deal. Get those two aces in your hand by year's end and I reckon this hand is ours.
Funding and a Regional before the end of the calendar year? Sounds like two aces to me...
If we get our share price north of $0.65...even if it is slightly under (due to Piggy rights effectively extending the time to be right by a further two years which will have some inherent value - thank you @Babbanap for mentioning that in the meeting)...most of us will exercise them. I will post more about this closer to mid Jan, but I would like to get other posters like @hunter2 to assist in running through options scenarios closer to the time to help the holder that isn't as au fait with options and how they work and why you need to care about them (if they go close to being ATM [At the money] or indeed ITM [In The Money]) as they are sitting in your account and will have value if that's the case.
As an example, RAC.AX recently had their options go into the money...I believe they were nearly $1 into the money and yet how many exercised them?
95%?
No
91%?
No.... Even less, I think it was low 80's.
ACCELERATED
The comparisons don't just end with deal potentials...
There is real talk of Dimerix possibly being eligible for Accelerated. It's also not impossible for us too.
If you are new to us and all things clinical trial like, the Accelerated program is one of four designated faster pathways for sponsors in the case of compelling drugs. There are many advantages of securing such designations. The biggest one is what it can do for you in terms of bringing forward revenue. Achieve that and it will be potentially quite immediately explosive in terms of share price propositions!
Did you know we are already Fast Tracked? It's a good first step and is validation in of itself that we are on a good track and hopefully destined for more as we progress.
PAR....Fast Track out of the way, what's next?
What is the ground work that Dimerix and possibly PAR need to put in?
1) Safety 2) No other drug doing what we are doing 3) Surrogates 4) Interim
Let's tackle each one briefly.
1) Safety At the end of the day, the FDA are wary, specially of the damage and impacts of Opioids. They want a solution, but it has got to be safe. Our safety profile is beyond reproach, specially as a SubQ route of administration. But of course we need to add to the Safety Database, we need this at scale, that's what the P3 will do.
2) For a drug to have the ultimate of all quicker pathways, that is Accelerated licence...there can be no other drug out there that is doing the bulk of what we purport to do.
We must be unique. We must give the patient something that no other drug out there can do.
I have spent some 5 years straight researching this drug and looking at competition. There is to date, no drug that can do what our drug does.
Symptomatic relief. Meaningful reduction in pain Improvement, function improvement, Duration of effectAND...as if that is not enough, some regression of the disease, reduction of inflammation and structural benefits. These benefits take place not over years and years, there has been sighting of statistically relevant structural positive ramifications in months.
This is what we need for Acceleration
3) OA, like many diseases, manifests not over months, it takes place over years, even decades. The authorities need a sign that our drug is addressing these longer term indications like OA sooner. Is there a marker, is there a sign that shows the authorities that by taking this drug you can make a meaningful change to the insult, the disease course?
Paradigmers, we not only have ONE such biomarkers, we have several. But it is not even several within a given class, it spans the sub groups!
What I mean by this is that we not only potentially address Dry AND Wet Biomarkers, we are potentially positively addressing multiple markers within the subgroups!
Take a look:
I've added the little red boxes in the above graphic9 with some of the fabulous indicators we have either seen to date or will investigate.
Three stand outs I must mention are of course:
A) COMP
B) CTXII
C) A Mozz favourite, HA
Check out the Appendix A for a high level snapshot of theses three particularly if you are new to PAR and certainly new to Mozz Posts.
The surrogates we can potential investigate also include the very important structural changes. Think positive Cartilage morphologies, reduction of BMELs and regression of Osteophytes. The best news here is that we actually observed this not after 5 years of study...not after 2 ...not even after 1 year...we saw this at 6 months.
That wasn't really supposed to happen. No one really understood how much it would change and how quickly. This one result in 008 changed our lives forever. We won't really see this in a commercial sense perhaps for some time...but it is working in the background for sure. The biggest proof for me, all time, is the acceptance of those changes in our P3 protocol by the FDA.
Two points here
1) It got accepted in RECORD time, 30 days...no if's no but's....no changes, no FDA 30 day cycle after cycle back and forth..
2) The changes weren't merely the superficial designation of 'OBSERVABLES'.
No no no no no ...these were UPGRADED to Secondaries.
Commercially, this is a motza...
4) Interim is indeed going to be pivotal.
I of course will have a detailed re-post on this as the interim draws closer sometime around the middle of next year. But in a nutshell....this will be one of the biggest clues for the authorities and for PAR. How is the program going, are we garnering the consistency of past studies like 005, 008, 002, Ghosh and Kumagi's work? Do we have something compelling finally at scale?
If we are and it's happening at scale (statistically significance on multiple targets)....there are three things that are going to happen:
A) Mozz is going to be quite very happy B) The deal making hotline is going to ring a lot more than it has been ringing so far C) The chances of Accelerated go up, certainly the designation is far from guaranteed and it is quite an effort and reserved for really special efficacious and value adding drugs the world haven't seen yet...but the chances increase, that's what I want, that's what YOU want.
I can't predict what will happen...I hope the data is great...I hope we progress nicely without hurdles or too many hurdles, I hope there aren't too many further delays....but what I do know is that the chance of material pharma regional and large regional deals goes materially upwards as we plough through this last phase of trials.
CONCLUSION
There aren't a lot of drugs and companies we can directly compare ourselves with. A few we can take inspiration from, a few give us clues about where we could be heading. Dimerix have done well to date securing some good funding. They too have had to wait for deals to start and they were also smart in that they progressed a USA deal later in their journey. I'm sure a lot of their holders would be pressuring them to strike a deal earlier...yes we all want cash...but seriously, wait for a bit longer and you will get so much more.
Interim also was pivotal for them but it also took some time after that to acquire a Big Region deal (USA). In our case it might be a little sooner in that our drug dosing profile is quite quick and we are studying patients out to day 404 (I believe Dimerix is looking at two years as a time endpoint).
We are a unique company with a unique product that at least in my view has a huge potential. I have a lot more researching and writing to do over the next few years. This molecule is complex and works in a plethora of different novel ways. We of course need more than just a great product...we need great financing...we need certainty and stability. Later, we will need totally new and different skills, marketing, distribution, logistics and negotiation skills (with payers and pharmas etc).
At the end of the day we will take this step by step...the biggest one for now is funding and the absolute progression of our Phase 3.
As we start moving this beast forward, more exciting things ought to happen and play out from now on....yes there will be some quieter times but I for one will be happy in the knowledge that things are starting to tick over in the background once we acquire suitable funding and once we get that first dosing announcement.
Good luck indeed to us all...
Mozz
Above (and below!) not to be construed as advice.
APPENDIX A
Relatively new to us?
Here are three major biomarkers that we have shown efficacy in. This is just a quick snapshot, take a look at multiple posts in the index below to pursue more detail on these and other biomarkers.
This one hit my screen early...I was just a kindergarten kid in terms of OA research back then (in some ways I still am!) Put your hands up if you were a shareholder back then and read this statement when it came out 10:
Let's view this graphically...
TWO - CTX II
This is one heck of a biomarker. It has bene labelled as THE MOST PROGNOSTIC of OA Bio Markers.
If there is one cartilage destruction indicators in your serum, it is this one.
Wouldn't it be great Mozz to actually SEE some early evidence of our iPPS hard at work to get an early clue as to whether this P3 is going to be successful or not?
Mate, take a look at this:
Yeah that's CTXII dropping by a mammoth 25%...What did Placebo drop by?
They didn't....
They INCREASED by 17% odd.
CTXII measures cartilage degradation...it literally predicts the destruction of articular cartilage, its measured in the blood.
There are studies that investigated these two biomarkers together and have found a distinct link between progression of disease and levels of COMP and CTXII. See reference 12 for further information. Here is the paper:
In terms of CTXII, it found that patients that were in the highest quartile of CTXII levels had some 4 fold increase of having radiological OA. Patients with hip pain in the same quartile drove this association to a 8 fold increase!!
Here is the paper, referenced below as ref 13.
THREE - HA
Yeah my fave molecule other than iPPS of course.
Such a supermolecule. IPPS stimulates the higher weighted blend. This one molecule has so much benefit to every fibre in our body. From fluidation to assistance in our immune systems. From wound healing to assistance in ovulation. This is one molecule you want to protect and to naturally stimulate. It is bene's iPPS that does this. There is no manufacturer on earth that has the ability to scale and produce this to an exacting standard and it is Paul and PAR that have attained the exclusive rights to it.
I've written about HA on numerous occasions and no doubt I'll have follow up material in the future.
APPENDIX B
I nearly forgot to include this slide...(see below)
I know a -LOT- of you haven't seen it or haven't paid attention to it. Please dont think I'm some sort of expert...I have seen people like Catherine S at work...I have seen the knowledge other PAR staff have, I am nothing before the real experts. All I try and do is be some sort of humble conjugate. Please remember to NOT rely on only me. YOU need to take into consideration the risks of this investment.
A quick story if I can: In the 2023 PR AGM I asked PR a question that I had memorised in regards to the prognostic attribute of CTXII...It took me a full 5 minutes to state the facts of a study from Norway dealing with quartiles and fold benefit (as briefly alluded to above in this post)...and then finally ask my question. I thought he would take a minute and and answer it.
Hahah - he took 7 minutes, he quoted all sorts of studies and papers all from memory on the spot In front of a packed room. DO NOT think PR is fumbling his way through this. He is way, way smarter than you give credit for. I'm not saying PAR do not need any help. I'm not saying PAR haven't made the occasional decision you and I may not have made or that they could've done with a little more UPOD. I am saying they know what they are doing in many aspects and have TOP Kols on board and expertise. I need to go no further than point out they have one of the world's leading Bio Statisticians Jim B. as a tiny example.
To get Dr D Felson on board early was coup of the decade. Let me tell you.
Ok one more story. Sorry...anyway...you made it this far into a Mozz Post right?
If you are good in research, you will have greater than 10 Peer review papers
He has 1000
If you aren't half bad, you will have at least 100 citations....
He has 150,000.
He has helped us design our clinical trial. He has NEVER done this for ANY other co. ever. I should know, I've met him.
Just take a look at these figures below. If it is all too numeric and sciency...the takeaway is that this drug appears to work both shorter term at 56 day...and longer term at Day 168. We want most of these figures to be low (negative) except TIMP-1.
APPENDIX C
I work in IT. As part of my job we need to do backups...
I enjoy posting on HC. The biggest thrill I get is explaining some of the complex science and utilising everyday examples to making these science concepts well...more digestible. Not only for you...but for me! But the most frustrating thing is spending hours of research, spending more hours typing them up and editing and then LOSING the lot because the site crashes. I've been thru this painful experience on two separate occasions in the past and literally lost 5 hours each time. I semi realise how Sir Isaac Newton felt when due to his dog called Diamond, accidently bumped the table with a candle and burnt ten straight years of work.
Instead of turning the dog into pure mince meat...he patted him on the head and rhetorically said to him "Diamond, do you know what you have done?". I fondly remember my dad telling me this story amongst MANY gem like stories he told me over the years. I want this level of patience. I know we have a good drug. I know there are funding hurdles...but you know what...I know these will work out. (Spec statement, not advice).
Nowadays I make so many backups while I'm doing a HC major post...the entire web page crashed right at the end of my work,..but luckily I literally lost 5 mins of work...I create backups within HC but also save it all to a word doc too. One must learn from the past.
Ok let's get on to the references...I thought I'd have two initially with this post...I have fourteen, some good reading here if you are truly bored.
Ps: Go PAR! Yeah that was for Huts, haven't heard from him for a bit.
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onight, another comparison, I've done a couple of these in the past, it's time to do another one while we wait with increased anticipation for funding.
Let's view this graphically...
(20min delay)