I actually might have missed the first question...lets take it from the first I had notes on:
Question - What happened with Marco? Why did he leave?
Paul said we need to be cautious at this time in terms of the discussion around the exact reasons for his Marco's. Marco will also be in the same position. The point is, did the company go through the due process to appoint and to separate him. The answer is Yes, we went through the right processes and today the fundamentals have not changed. The company is in a very good position to move forward.
I can assure that the board has given this a lot of thought and I can assure you its for the best interest of the company moving forward.
Question - Can you elaborate on the reasons you decide to step away, it has been resolved but can you elaborate on this without it being too personal.
The reasons relate to my family and not to me, I have not had any health issues personally. It was out of respect for my family. I don't want to talk too much on that as I will get emotional.
>> MOZZ NOTE: yeah this one was prob a question that didn't need to be asked at least in public but I do understand that the gentleman asking it may have got a number of curious inquiries about it. Kinda a personal one here.
Paul then went on to state that he is now stepping back in with same enthusiasm and rigor and vigour that I've always had for the company. This is my fifth baby. Paul made a slight joke here about someone asking if he had a mental breakdown! He said I prob have but it hasn't ever been diagnosed. No it wasn't anything like that.
>> MOZZ NOTE: Always good when CEO's/Chairpersons/MD's can add some humour, I do remember Paul stating back in the 2019 AGM that we can't just yet buy ourselves a Porsche or Ferrari which brought out a few chuckles at the time.
2019 AGM? Anyone remember these comments?
>> MOZZ NOTE: The following is yet more learnings for the Mozz, gee I didn't know the background to the division between ERT and Bone Marrow treatment that specifically PAR is studying, take a read of this Question and Answer:
Question: Congrats on getting the company to this point. We have heard we were deal ready since about 2020, comparison to Humira. We are now in a P3 and more de-risked. What has been feedback from distribution partners, wouldn't a distribution deal be more lucrative compared to Humira. What are they waiting for? More data? Peer Review? Is there a concern we don't control the manufacturing?
Yes we have been deal ready, one of the key components of where we are today which is further advanced that we have ever been. It has to do with our MPS P2 study as an example. There are a lot of questions that go into the asset. A lot of commercial companies (in the MPS space as an example) say its great that you have shown that this drug works in terms of pain and function in people who are on ERT but in reality 50% of the market is not treated with ERT they are treated with Bone marrow transplants (BMT), so they ask, does your drug still have the same effect on patients that are treated with Bone marrow transplants, until we get that data they cant really decide if the asset is worth X or is it 2X because you are covering the market.
The study in Adelaide looked at MPS I, the same MPS I study that was conducted in Germany. But these subjects were all treated with BMT. So the exciting results that are coming out of the Lysosomal conference in Sydney the investigator will talk specifically about how the drug is working on subjects with BMT as their primary treatment and iPPS as the adjunctive therapy.
With the combination of data that answers the commercial questions you get to a point where it starts to really become very interesting for the Pharma companies. So we have had those discussions and now they are now in the position to say OK we can market this product whether they are being treated by ERT or BMT.
To to answer the question often commercial companies want to see the full piece of the puzzle.
In relation to your comparison to Humira, unfortunately those good old days of companies getting assets at P1 are largely over, Pharma companies are wanting data to suggest that they are going to move through P3 (not just P1). Humira was a DM drug. We presented in our recent discussions with the Chinese and Big Pharma companies that this is transformative data in that we now have DM insights and that's a game changer.
RA was similar to OA before Humira, it was a debilitating disease and one tenth the market size of OA. But in terms of RA the situation the patients were treated with known drugs like methotrexate and corticosteroids and at that time any further work around those drugs wasn't really valuable until DM drug of Humira hit the market. The same situation applies to OA.
I showed the Big Pharma companies when we spoke to them a paper that had been written by researchers showing 37 different compounds that were all ear marked as DM compounds in OA. Phase 2 and Phase 3 studies of all of these compounds, every single compound failed.
>> MOZZ NOTE: My emphasis added above. This shows just where you and I stand in terms of sheer market potential and possible trajectory. My views.
Big Pharma are waiting a little bit later in the process to see if it has legs. There is no doubt that DM is of huge interest and there is no doubt that as we progress further into P3 we can demonstrate safety and we can demonstrate that we are going to have an effect and that we continue to do further data - I think we are going to see real significant interest in the asset.
Pharm companies are waiting on DM data.
Most of the 37 failed indications were run by Big Pharma so they themselves know the challenges of DM in OA.
Paul then gave example of Merck's Sperfimerin and Pfizer's Tanezumab.
Question - CRTAC1 is this a biomarker being investigated?
Paul mentioned Dr Virginia Kraus works for us as a consultant along with Stefan Lohmander .
"Virginia has been a tremendous benefit to our company as [well as] Stefan Lohmander".
We sent those data to Virginia and she was like "Wow...this is amazing", she wanted to know more.
She will be an author on the paper for Day 56 and 6 Month.
>> MOZZ NOTE: Amazing team of experts including Dr David Felson who Paul also mentioned. Dr Stefan is a new one to me, see reference 8 for further info. Incidentally a pal asked Paul later on after the meeting and he said he would find out from Dr Skerrett if CRTAC1 is being studied specifically.
Question - Retreatment, Good feedback from person that has tried it.
Many of the fund managers have had treatment through SAS. We know it works. All investors should know that we have a drug that works.
Being conducted as we speak. Required for package insert. Good retreatment data - They don't go back to baseline.
Question - Path forward to delivery of info to FDA. Timeframe seems to keep moving out. Sources of recruitment, how many are we looking at for recruitment by June next year.
Paul said it is about 500 patients. That will see us through to dose selection. Benefit of Fast track is that review can be accelerated.
Dr Skerrett interjected here - Clinical trials can be challenging to recruit for and to comply with treatment procedures and follow up treatments, we are recruiting from a wide base to ensure we do this in the planned time frame.
Question - Total recruitment to date?
Not specified but we are getting more active in terms of numbers of patients to be ready for the first DSMB review in Dec. PAUL - We are on scheduled to meet our timelines to meet DSMB Dec and 500 subjects recruited by June 2023. Then does selection and resume Second stage.
Discussion about timelines to launch. Mentioning of Faster pathways. Priority review also mentioned.
Question - What is reasonable for FDA to review data. 6 months under Priority Review, would take a few months. Priority shortens generally 10 months to 6.
Question - Plexus applies to OA? Yes.
Paul then discussed partner selection. They need to be committed to our plans and they need to have the right distribution that aligns with us. Lot that goes into it. Sometimes it looks good on the surface but when you delve deeper it may not be the right for us. The pressure is now on them.
Paul again mentioned faster pathways in light of NSAIDS report being unfavourable and Docs having limited options coupled with serious and unmet need, opioid crisis etc.
Question - Will MPS pricing affect OA pricing. Yes, Paul discussed.
FORMAL PART OF THE MEETING THEN TOOK PLACE
MOZZ SUMMARY
Thought it was a good meeting, there was enough time for questions but the thing I liked is that once the meeting was closed we had at least some time to mingle. Its never enough but that's from my perspective...I still didn't get to meet a couple of staff members which was the same like 2019!
Paul gives me the impression he is very committed and very enthusiastic, its all steam ahead. We have a big year coming up next year with many milestones to tick off. Of course I, like you, would love the SP to be a fractionality more reflective of our potential...but I do think next year is going to change the gradient on this share price...for the better.
I got a lot out of the meeting and a number of leads to follow in terms of further research and info to be presented, all coming your way!
>>MOZZ NOTE: How does one end this Four Part'er AGM extravaganza? Oh it would have to be some choice PAUL quotes... How about this for a series of statement from our number 1 shareholder:
"The situation is that....I have probably never ever felt so excited about Paradigm to what I do right now".
"After having in depth meetings with the Big Pharma companies and those companies saying that this is truly transformative , these data is just amazing, where have you been, why haven't we seen this before?"
"The reputation of Paradigm now is just getting out to those Big Pharma companies is truly exciting"
"We are now seeing there are big companies who are sitting back and saying they simply can't believe it, these data are just amazing".
AGM 2022
(20min delay)