ar have done a lot of work over the years. Sure, one could make an argument that they might have done things differently if they knew how things were to play out, but at the end of the day, here we are.
There is no doubt there are two distinct sides to this story, namely, CLINCIAL/PRODUCT and separately, FUNDING. We won't have a company if we only have one of those sides in check.
I've been following the science side fairly closely to ensure that what PAR are saying and reporting is true. One could actually say I've been to the ends of the Earth to check this. I'm happy. Like, really happy. Not saying that we are done, not saying that there might still be some tinkering to go, also not saying that we can start selling in a few months time!
But tonight let me give you a write up covering a little of the funding side, an example of what is possible.
Please as always, do enjoy.
OUR NEEDS
So according to PAR we need around $50 to 60 Million dollars, that's USD, so the conversion is about $72 to $86 M Aussie. This will get us through the Phase three. But really we prob need a touch more as we have monthly admin fees Let's just round it to a even $100 mil AUD. Now none of us want to raise this via on market and a highly dilutive raise.
So is there a viable alternative? Something that's not going to result in us immediately having to issue millions of new shares.
Do we have a lot at the moment?
349,500,000 shares or so. It sounds like a lot, it actually isn't.
Let's take a look at a few companies, some smaller ones like:
But it ain't just smaller companies that I'm picking, take a look at some of the bigger ones:
So my point is that 350 mil isn't a lot...if we do go through some future dilution, I'm hoping it's a very select amount to very select parties. No, I'm not inferring PAR and their close 'mates'. I'm meaning potential Funders or even Bio Pharma that want a stake in us as a vested interest, so they indeed are like venture partners. Winning when we win, losing when we lose...skin in the game but not transient...for the longer term. We need longer termers on our books...This will happen naturally over time as we get ever so closer to the ultimate prize, the license to SELL!
The lovely thing for us is that we aren't just going to one market at a time, in tandem....we are going for simultaneously harmonised parallel markets. We get the GO for the USA, it automatically equates to Europe, Aus, Canada and even UK. It will be a very big result for us and you know what, you...and I...have a clue as to how and if, this will be a success....
*Whispering now* ... The FDA has given us a sign that the 2 x 2 dosing should be a go! Why am I whispering that? Because it seems like not many are trumpeting this around, sure they are waiting for the official IND to get accepted, but it should be an easy glidepath from here.
Smooth Glide Path? Yes please FDA.
Indeed the FDA haven't come back with feedback that we have to re work our entire plan, removing entire chunks out...they haven't come up with major safety concerns, with objections on our data submitted...in fact the mere fact that we got that announcvement infers that they saw the 008 data and they liked what they saw. Liked it enough for us to be able to progress as long as we incorporate their comments, we stick to the landing pattern.
This is spectacular for us LT holders. But it's not only great for us as holders...it's great for a future partner, for a future funder. They will read what the FDA said...they will see what our data says...I can't see how they can't be but impressed...I am impressed, they will be too. There is no drug that these funders have seen that addresses Inflammation like we can. There is no other company they have funded that has the ability to reverse OA...to assist cartliage growth...
I would love to be a Mozzie in that room when Par presents these five powerful points...:
That's what I call a heck of a report card, you reading this that own shares, you are a part owner of that above. Be happy, be proud. You are the owner of something potentially very, very big, and now endorsed by the biggest pharma market authority on Earth.
Some like to see this info graphically, these two below charts are simply stunning, not just an increase in cartilage thickness, not just an increase in cartilage volume but placebo continued to get worse AND this observation wasn't sighted over18 months...no not even 14 months, mate, buddy, not even 8 months....this was shown in just 6 months.
That's spectacular.
Just you imagine, no one in the world has ever seen these results with a drug thats safe and durable. We have so many other observations such as regression of BMELS, rescinding of Osteophytes but wet biomarkers too along with inflammation itself.
Any potential funders that are following Mozz posts - this is one that's worth paying for.
CLINU - WHO?
All very good Mozz, but are you just spinning theory, has anyone ever done these fund like programs before? Are there any practical examples?
There is an Aussie company called Clinuvel. They specialise in a few therapies, one area is developing treatments for patients with certain skin conditions like adolescent and adult xeroderma pigmentosum, variegate porphyria as well as even arterial ischaemic strokes.
Back in 2022 they managed to get a funding deal.
There was a funder called Carlyle, they came to the party for Clinuvel.
"Carlyle and its life sciences franchise Abingworth, working with their recently formed development company Launch Therapeutics (Launch Tx), to provide non-dilutive financing of up to US$170M, consisting of a US$120M commitment and an option to increase funding by a further US$50M".3
The deal above was predominantly to fund the Wet Age-related Macular Degeneration which is a market valued at around $9B USD. 4
The OA market is said to be worth approx $15 B by revenue in the year 2023.5 But one could certainly make an argument for many possible indications that could be one day in the future be addressed by iPPS. Even if you just take the Heart Failure with Preserved Ejection Fraction (HFpEF) market alone which PAR have started investigating some years ago, it is highly accretive.
A simple stat here is that there are approximately 900,000 individuals in the UK alone that are affected by Heart Failure. It is the commonest cause of hospitalisation in individuals above the age of 65. Here is the break down....I've highlighted the one that applies to us:
I often receive emails and calls, even the odd fax (remember those?) regarding different formats to present various data. Of course, the Mozz Quiz® format is a stand out*( * = Self voted)
Let's now go again with another quality Mozz Quiz:
HOW MANY DRUGS ARE THERE TO ADDRESS THAT THIRD GROUP ABOVE, HFpEF?
A) There would be a number of them, at least 55 different types of drugs?
B) Nah, not so many, let's try 25
C) Less than 4 ???
Well C) is the answer, the actual granular answer is none.
There are no drugs to address what's greater than 50% of Heart Attacks.
Only iPPS has shown some efficacy in this area. Here is a quote for your enjoyment, check out reference 6) for more details,
"Like HFrEF, there are currently no disease-modifying agents available for HFpEF that improve clinical outcomes. Several randomised controlled trials evaluating the efficacy of therapies routinely administered to patients with HFrEF have failed to demonstrate benefit for HFpEF patients. As such, patients diagnosed with HFpEF have relatively few treatment options, with ESC guidelines advising the treatment of any underlying comorbidities and resolution of congestion with diuretics when present".6
Here was Par's announcement in this area, just have a read through those highlights. This is on the back burner, it will resurface one day in the future.
CONCLUSION
As we move forward, excitingly we have a green light to do this now, thank you FDA, our prospects of funding a P3 only increase. Funding is key. Get a strong statement in this department and the share price is going to re-rate (that's not only my opinion, I reckon that'll be a fact)....
PAR...before, now, and later... just plain busy! '
Par have their work cut out for them, they will be extra busy bees in the next few weeks but they will be bees with a solid adrenalin rush as they are backed by the Giant FDA. Follow their comments, implement their tips and we could just have the start of the final trial opening up really soon with the chance of some sort of non dilutive or lower dilutive funding arrangement materially increasing.
This is what I want. This is what holders are waiting for.
Bring it on!
DYOR applies
PS: I am going out on a bit of a limb here, the entire PAR staff have worked their butt off and I am still in awe. I do want to highlight just one example of how hard these guys are working for us. Here is a quick Mozz Story.
I love my sleep. I need 7 and a bit hours sleep. If get that, I'm a happy camper. Anything under 6 hours, I get a bit tired unless I have a stellar day In front of me! My Point? A certain employee named Karla has been getting up multiple times at night ...not just on one random night...but many, many nights just to check to see if there is an email from the FDA and then to act accordingly. I want to publicly thank her for her diligence and all her hard work. It's a big sacrifice but I know the vast majority of the 500 odd readers reading this all appreciate the efforts of you and all PAR staff. Please continue to do this for us, it is very highly appreciated.
Your efforts are NOT going unnoticed. Yes you are working hard for yourself, but you are also working hard for us.
ar have done a lot of work over the years. Sure, one could make an argument that they might have done things differently if they knew how things were to play out, but at the end of the day, here we are.
(20min delay)