1) Don't shoot the messenger. Meant to be an account of how it transpired with a few of my notes in-between, 2) I may have internal bias, you should do your own research and gather opinions from not just any one person. 3) This is my observations of the meeting. I may have interpreted in a certain way or have missed points etc. It is not intended to be a verbatim account of all that happened. etc 4) I'm not sure if a recording of the meeting will be put up on the website, I'm assuming it will so I won't go too heavily into all the detail but I will spend a bit more time detailing the questions (Part 2 to come soon) as these sometimes don't make it onto the site.
THE MEETING
The room was full, with people standing at the back. There were a few minor technical difficulties at the start. A number of staff were present including four of the Reg team as well as a few staff from the US and Simon White.
Paul started off by thanking John Gaffney for his tenor over the last 10 years of service. Paul also then stated that Helen will be leaving and thanked her also for her services.Then he introduced Abby (CFO, Company Secretary) who handles the finance and he also welcomed also Beverley (Business Director). He also introduced Amos.
Paul started by acknowledging some past staff including Kevin Hollingsworth - he quipped that Kevin used to call Paul after every announcement and Kevin would say to Paul:
"What's wrong with the shareholders, don't they understand that this is going to be the best selling drug ever?"
Paul then mentioned Professor Peter Ghosh who passed away around 3 years ago. Paul stated that:
"He really lit the fire within me about pentosan". Peter said to Paul that you know that there is only one drug that really works for OA. Paul sustained a bad knee injury and it was Peter that put Paul in touch with Bene Pharma. Paul was treated under the SAS and 4 to 6 weeks later Paul exclaimed:
"..it really worked and it was like a miracle. It had completely resolved the Osteoarthritis in my knee".
Paul also then thanked the Paradigm Staff.
Paul then also stated that he as a substantial shareholder is aware of the grief that holders are currently sustaining and that he too underwent the dilution. He also stated that the share price is not at all reflective of the enormous value of the company and that they were working their very best to get the SP.
Paul talked a little about the 12 month duration and the positive synovial fluid biomarker changes and the positive cartilage thickness which is the first time that any company has published this 'triple crown' in relation to an OA trial.
Paul mentioned: MPS I has closed MPS VI will be reading out in the next few days
$30 million raised as we went down to two quarters of remaining cash.
We have listened to shareholders in the last few months and we are refreshing the board, we are bringing more commercial business acumen onto the board and you will see those changes as we go through the next few months.
PAUL PRES
Paul presented the milestones slide:
He again acknowledged that the share price is depressed and we understand that and we are all upset about that but the company continues to to make very solid progress in our pursuit for getting this product to market starting with the FDA clearance.
Paul talked about some of the milestones, he mentioned a number of doctors and clinics wanting to join the clinics as part of the trisal. He mentioned the OARSI conference in March and posters recently presented at the American College of Rheumatology conference.
Paul mentioned that the company received a binding offer for a regional MPS deal but the Paradigm board the rejected low base offer. However, this was an indication that companies are interested in the programs.
DONNA PRES
Donna presented an update on the P3 program. 600 patients randomised into the Stage 1 002.
It was determined that the minimal effective dosing is the 2x2 which is the optimal dose to continue on into our next stage. Safety Analysis were conducted in Dec and June. The DMC determined we could proceed without change.
Hope for OA site launched
We activated an additional 40 sites (to 120) across 7 countries.
We developed an alliance between NFL alumni. We now have the ability to inform them of progress in the company and the ability to recruit from them in our P3 trial.
We also completed three non clinical toxicology studies to evaluate adrenal studies, no adverse adrenal toxicity findings in 2x2 dose.
Donna then spent some time going over the 008 program observations in terms of biomarkers. Primary End point Achieved Identified several synovial biomarkers reported on Disease Progression Biomarkers identified Statistical significant in Woman pian and Function 12 month follow up - sustained significant improvement Worms Analysis Quantitative MRI analysis Increase cartilage thickness and volume Reduction of Bone Marrow Lesions Reduction of Synovitis
Showing Clinical mechanistic as well as structural benefits from a single 6 week course of iPPS.
PPS has demonstrated both Subjective and Objective measures compared to placebo.
Significant improvements in PGIC which is held in high regard with authorities.
NEXT?
Protocol development for next stage of P3 with 2x2 dosing. Trail numbers to remain at approximately 600 patients. We will submit this protocol on Q1
TGA provisional application comprised of:
Clinical Development Plan
Data (008 manuscript)
Other literature on OA manuscript of available pharmacology's in Australia.
MPS PROGRAM
Two trials conducted MPS I and MPS VI MPS VI conducted over two sites.
PPS has the potential to modulate the biomarkers that are associated with joint degeneration.
Higher penetration rates possible in this indication due to highly engaged patient advocacy groups/community.
We will now focus on:
Top line read out for MPS
Potential for expedited or provisional approval submissions in Brazil and Australia
Continued discussion with potential partners
Manuscript for Peer Review
Number of separate meetings to come up:
<<Mozz Note: I spoke the Reg team, most are fairly new but are keen to tackle the upcoming work load, they will be busy next year!!>>
BEVERLEY PRES
MPS likely to be a regional disease due to concentration of patients in the respective regions.
In China, opportunity is more in OA.
We are also pursuing other areas like US/Europe.
PAR attending at partnering meetings, we have also sectured licensing agents. Plexus has 30 years of experience. Yafo is a Chinese based agency and they were the ones that secured the partnership between Haisco and Biosplice.
<< Mozz Note: Above Headline/ref was not presented in meeting but was mentioned >>
Beverley then spent some time giving us an idea of how the partnering process is a long and involved one.
New and heightened interest has taken place as a result of the durational and structural recent announcements.
Data for MPS VI will also be a key data point in terms of negotiations.
"We are confident that our partnering efforts will be successful in one or more regions by the end of June 2024".
<< Mozz note: How about I break up the next fact that she presented into the format that many of you adore....(Ok that was a bit strong, many of you tolerate?)
DEMOGRAPHICALLY, AS PRESENTED BY BEVERLEY, WHAT PERCENTAGE OF THE CHINESE NATION'S 1.4 BILLION POPULATION ARE MIDDLE CLASS, EMPLOYED, URBAN PROFESSIONALS?
A) Ah mate, most of them live out in the rural parts...no more than 11%
B) Nah man, things have changed over there, have you seen Shanghai recently? It has to be at least 17% now
C) SIlly, you are reading a real life Mozz Quiz, double A) at a min. 22%
The answer as read out by Beverley was 70%.
<< Mozz Note: In light of the above, the below slide that was presented makes sense but blows me away... This is the eventual potential we could face one day...
<< Mozz note: At 'only' $1000 per patient and only 10% market penetration the volume multiplier trumps US. Remember, this is not one and done, many will need boosters, once pain slowly starts to gradually come back, they are going to potentially put up their hands for a booster>>.
She then mentioned there are good percentages of insurance funded by private or partially funded by the patients.
Finally the pharmaceutical sector has evolved, in the past there were delays in getting drugs to markets due to onerous clinical trials. Now global trials may include a subset of ethnic Chinese participants an these will be accepted by the regulator which allows us to access the Chinese market.
No longer do the Chinese authorities need the drug to be pre registered in other markets.
Many companies consider China as a key market.
Beverley then went through the steps involved in getting to market.
"We currently have multiple companies at this stage in China, Middle East and Latin American creating competitive tension".
Many companies are currently reviewing the confidential information across a number of regions.
"We are confident that one of these will proceed to a deal by the end of June next year".
ABBY PRESENTATION
<< Mozz note, I didn't quite get all the comments/details here as it was a bit hard to hear...>>
Update on our funding.
Raised $30 M.
With current funds R&D Update etc will pro forma take us just over $100 mil Cost cutting strategies have been implemented to focus on OA program.
PAUL WRAP
We are very confident that we will bring this home by June 2024 and Im sure if we dont there will be plenty of people that will remind me in the next AGM.
We want the deal more than what you can imagine, we are wanting the commercial companies to see what we are seeing, the tremendous value that this brings.
Paul then ran through the expected milestones:
Paul specifically mentioned the submission for the revised protocols being 2 x 2 for the FDA to go in Q1 2024.
He also mentioned the submission to the TGA OA Provisional submission will start in Jan. The TGA wanted to know last time what was the durational aspect of the drug. We suggested it was 12 months and the TGA said they wanted controlled data on that regard.
Paul then mentioned that licensing for OA and MPS is likely given the immense amount of activity taking place.
This concludes PART 1
In Part 2 I'll cover the questions...hope to get it out in the next day or so.
(20min delay)