MST - Presentation 17th June 2021

...Another good PAR wrap.

Not sure if a recording will be provided, here is my summary and highlights particularly if you couldn't attend live.

Caveats: Only my thoughts and personal interpretations. I'm not an advisor, DYOR


Note: You should be able to left click on the slides to enlarge in some cases.

Breaking this up into two parts as I had a few notes to go back over...

PART 1


Good initial introduction by MST panel

"decreased risk, increasing valuation" makes for good valuation at this early stage

"Quite unique" with unofficial trials ie SAS which has given us insight (Normally it is locked up and we don't get that insight at this early stage)

Also through EAP...these are good aspects of PAR.



Paul then spoke:

Paul mentioned this was the high level agenda for today:

• Global P3 Program
• Update of where we are and where we are going
• Look at other clinical trails and R&D Pipeline
• Questions

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Paul started with the std. disclaimer and then went on to a new slide

Some refreshed slides, example below:




Paul then mentioned the patents as well as touching on exclusive supply and only FDA approved PPS supplier, Bene.


Acknowledged that there are other PPS suppliers that exist but they are not FDA recognised. The agreement between Bene ensures Bene will not supply others in competition with our indications.



Size Of market briefly covered.

72 Million + in USA,CAN, EU5 and AUS. 81% dissatisfied.

Market demand covered in terms of what the current treatments can do and our market op.


Paul then gave us an overview of the Global Harmonisation:

New slide:




Necessary protocols and discussions given by FDA before Type C

Type C then conducted for two way guidance and questions.

IND Submitted 28th March





FDA 20 minute phone call, new study submitted and they hadn't had time to review those docs. They were likely to have questions.
They asked us to pause and wait for list of written questions. 6 Questions were asked out of a dossier of 30,000 pages of Info.

"We are now in process of reviewing those questions and answering those in complete details and submitting a response by end of June.We hope by end of July the FDA will allow the IND to be opened." Aug 2021 first patient to be dosed.


Paul then went on to discuss other programs in action:







Paul mentioned 008 study - Synovial fluid study. Comparison of Biomarkers before and after.

Paul mentioned that just recently ANVISA has given us a go-ahead as well as (new info CONEP has approved P2/3 in MPS VI. (Mozz note CONEP is Ethics Commission approval)

008 also ethics approved, 50% recruited, prelim results hopefully by end of this year.


Then another new slide presented (to keep me busy copying and pasting while the seminar was going on??)
R & D Pipeline





72% of patients got back to pre pain levels with iPPS.

CHIK continues to spread into North America

Heart Failure - moving not animal model, things looking good with initial results coming back.
Echo cardiogram, most animals are doing well compared to placebo

ARDS in Aus (Viral induced).


Upcoming news:




ARDS and CHF prod -circa Q4
002 - Aug this year anticipated
008 Prelim data before end of the year












I'll continue in Part 2, coming soon which will cover the questions.