Hmm I thought it was a good presentation overall, Details, and addressed some good points.
Some highlights...
When Donna presented this:
...she clearly stated this was a
conservative timeframe proposal based on other OA studies and that PAR would adapt and re-model them as more patients were recruited.
There is at least some chance it may be quicker? Good to see some UPOD.
008 recruited at just over 50%.
Justin also restated increased inbound communications from potential partners since opening of IND.
Don't want to rush a deal as we may leave considerable money on the table.
Launch broadest and strongest label possible.
Best reimbursement price possible
QUESTIONS(Thought I'd add this section in case it isn't included on the website later)Q1 Level of interest of Big Pharma?
(Paul) Overwhelming
Many commercial entities recognise that we have a blockbuster
We have had some specific requests from some companies to enter into negotiations
But we have to be cautious and particular as we dont want to leave a lot of value on the table.
We have also engaged with banks in the takeover area.
"Best in class" deal being sought after.
Q2 What attributes is PAR looking for in the next CEO
International search firm has brief.
We are looking for:
- Pharmaceutical exec that has same passion to bring this asset to market with broadest label in shortest time.
- Person should embrace PAR values
- Deep contact into Pharma companies that we can get to decision makers in short time
- Someone who has worked in the Pharma industry and currently resides in USA typically.
We are in interview stage with short list
Q 3 Rationale of changes to protocol for 008
Donna - based on interaction with FDA.
Their q's centred on findings in one of the 26 studies.
Uncertainty that was only seen in rats, the FDA was unsure about this finding. So we changed the protocol for Adrenal
Q 4 Heart Failure Top line - is it still due this quart, is this still the case
Ravi - pilot done, research collaborators are finalising. Yes in the next week or so.
Q 5 What are the steps after 008 in terms of what FDA require in pursuing DMOAD
Donna - The DM requirements from FDA are currently based on radiographic findings. Field of OA has advanced to MRI and Biomarkers
We are studying all of the above in 008.,
Once done and we have the data and it has been reviewed with experts, we will approach FDA with the finding and how we can put that together to out it forward for a DMOAD pathway specifically with our product.
Q 6
Is Par exploring any non dilute forms of funding
Justin:
Yes we are looking at non dilutive financing.
Q 7 Originally 002 was 2 years, now 3 years, please explain
Donna : The study has extended in duration.
It involves enrolment of 938 participants over two stages, so there will be some interruption while we consider dose study
The timeline we have show you is very conservative and is base don studies in the field. When we have our own data we will be able to update the shareholders on the revised projections.
We chose to be conservative as over the past 1.5 years we have experienced delays. Certainly the interactions with the FDA were delayed.
We are now in position to support the sites to get patients screened and enrolled and to keep the sites active and productive. We will update the timelines.
Q 8 Future fundings - Can Bene take a stake?
Paul - Bene is a small shareholder in Par, not in any discussions with them taking any more stake, but that is always an opportunity.
Justin - nothing to add to that specifically , sources of capital over the next few years, we will continue to review.
Q9 What % of patients could be filtered out due to Adrenal observations
Donna - We don't expect a large no. of exclusions. If in unlikely event we find many are being filtered out we can go back to FDA but we dont believe this to be the case.
Q10. What is additional cost of new requirements
Justin - Still working through what this looks like. We will get a better handle on this once we begin recruitment of 002.
Q11 - Recap of data of data that shows DM
Ravi - regulation of inflammatory cytokines
Proteins that degrade tissue
PPS has been demonstrated in our preclinical studies and demonstrated a reduction in these key Cytokines.
Reduction of adverse re-modelling
Paul - All the info Ravi mentioned comes from Peer reviewed papers.
Downregulation of nGF
Quotation of other studies, PPS can block ADAMTS4/5 (well known targets that can break down Aggrecan)
Clinical Outcomes from other studies, Reduction C2C (Cartilage breakdown)
COMP reductions
(PFE and Lily have funded some 32 programs and found that there were too many side effects in addressing these common targets).
Other mechanisms to follow.
NEW FLOW SLIDE - Wrap up by Donna
Note:
008 we will announce when fully recruited, read out when 100% have reached Day 56.
PAUL - FINAL COMMENT
Huge market opportunity. In excess of 10B Sales per year, could be much larger if there is a DM model,
We are moving as quickly as we can, please bear with us as we maximise the value for the shareholders.
(20min delay)