MOZZ NOTESDisclaimerOnly my interpretation, not exact quotes.Could've missed points.Don't rely on this.
(Recording to come on website but thought its nice to have a premlim summary for those that couldn't attend)
PRWhy do it now?We have 4 qrts, by Sept we will only have 3 quarters of cashSo we know the equity markets have been effectively closed for 2022 cal year except for last 6 weeks where there has been a window of op that has opened up.
This window also opened when we got some inbound inquiries. They questioned whether PAR want cap now.PAR thought long and hard about timing. We wanted to take adv. of the sp being higher than $1, not at a 70 or 80 c would have bene a disaster for us.
We believe the co is undervalued even at todays prices.WE wanted a certainty.Try and secure a commercial agreement ie MPSYes I said that we wanted to do a non dilutive raise in our last pres, but things have changed since then in terms if the 'closed market raising conditions'.
We want to extend the runway in 2024 as much as we can.Co. have been founded in the money form friends, family and retail , we wanted to give something back to retail.Why raise money at $1,30 when we were at $1.96...instos look back at the last 30 or 60 days. Instos was discussion around VWAP price was $1.46, this is a 8.2% discount., Not ideal, I understand that but investors don't want to invest in at the last SP traded price.A few months ago this would've been under $1.00.
MARCOHomerun to a Grandslam - 008 results potentially, additional trend analysis.002 -interim look at first batch
- Tax Refund next year
- New IP
- International Lysosomal conf.
- Continue to drawing attention from BP
- Canine study - Q1 Next year 20 weeks = 3 years , likely effect on human knee after 3 years of administration.
- Effect on Disease Progression1st half- dose selection.2023 Agreement - non dilutive funding potential in regards to MPS.
Increased leverage with additional cash on hand.008 top line in Sept.Biomarker study- assessing changes over multiple measures associated with DMPositive readout could mean :
DMOAD will move to 2nd line to 1st line - 2.5 times the estimated current price.Very important study
DONNATimeline presented.
Fast Track -gives us a nice relationship with FDA and endorsement from FDA in terms of potentially meeting unmet need in OA space.
Pain and Function needed for DMOAD label.We are hoping to be the first to put these together.MPS Program updateOverviewPresentation in 2023 conf. Prestigious conf.MPS half enrolled.
PAUL:End of Sept and 6 month, 12 month of 008 will be a look through for main trial.
Canine v important study - proxy into likely DM eg 3 years study via canines.
MPS data to be presented, will be very exciting.
Lots of news flow to come and how the programs are running and read out.
More than 100 mil of cash.
QUESTIONSTiming or raise - answered by Paul at start
Recording will be added to website.
1) Why did SP run so hard recently in your view?
PR: No. of different factors
After Covid , Donna, myself and Marco managed to get out and see a lot of investors, this was the first time we could see investors and reinforce the fact that this is a P3 asset. Still undervalued in our opinion.
On market buying of the stock. possibly from intos. Made up for lack of buying in last 6 months
Exposure to current executives (Marco/Donna).
Phase 3 asset - de-risks
Lots of positive things now happening for PAR.
2) What gives the co confidence on the 008 clinical trial?
Donna - trial designed to look at bio markers after we saw promising signals in serum in P2.
PPS patients had lower evidence of destruction of joint cartilage than controls.
Quite compelling.
Significant in a clinical sense.
We had a careful look at MRI's in P2 and saw that the pps BML's were reduced compared to controls.
Radiographic marker decreased.
Previous signals in two prior studies gives us confidence.
Consistent clinical effects.
Lasts for a considerable period of time. Heard evidence from SAS patients for example.
Durable responses could be associated with DM potential
3) How will the 008 top line be presented? If the primary endpoint is not met is there any benefit in continuing the 6 and 12 month reads.
Donna - we have worked with statistians to determine plan and what's to be included. Changes in biomarkers over time and clinical responses to pain and function compared to controls.
First set of data will tell us about these.
Why keep going if we don't see something? We keep going because the DM effects are measured by what happens in the joint, these findings may not be apparent until after a number of months. Level of sensitivity and when we can see changes on MRI.
The MRI will be again conducted after 6 months. Stronger change notices in the anatomical point later on (6 months)
12 month data will be v valuable in terms of durational effect observations
4) What in your opinion does an MPS deal look like?
Marco - It could vary depending on terms
Some sort of upfront milestone to compensate us for risk and expense.
Co-development for further investment in P3.
We would like the partner to let us manage the trial
Royalty at back end when product is approved. Commercial development either on net sells or net profit depending on how we structure
5) Do you intend on participating in this offer
Paul -Yes, outlines in ASX announcement
DYOR
(20min delay)