Overall thought it went very well.
Was relaxed and Paul did a lot of good explaining.
Below is not an exact copy of what transpired. It's what I heard. Don't rely on my interpretation. It'll hopefully all get recorded anyway. DYOR
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INTRO
Ozempic like administration Canada provisional mentioned Very nice explanation of joint breakdown Coverage of synovitis, JSW, bone outgrowths, walk through OA stages.(First time PR has done this, was nice to hear).Lack of therapeutic options at this last and end stage.
Very nice explanation of joint break down
Coverage of synovitis, JSW, bone outgrowths, walk through OA stages.(First time PR has done this, was nice to hear).
Lack of therapeutic options at this last and end stage.
New MOA, iPPS promotes cartilage growth It also reduce enzymes that breakdown cartilage Dual activity Downregulation broad acting on inflammatory cytokines Management of Disease.
Demonstration of utility of iPPS -v- other drugs
Peer review publication to contain Comparison with available OA medications
HA and steroid passed MCID and separately, iPPS, single largest effect.
Large amount of Phase 2 and other studies conducted
Consistent data; significant reduction of pain and significant improvement of function of joint.
005
Pain and function improvement
Along with BML improvements
Positive shift in medial shape
Noticed significant legion shift for this patient
Serum biomarkers also mentioned, EG comp, CTXII, Adamts-5
008
Pain and Function comparison to PBO.
Structural example (Cartilage Thickness)
Mentioned increase of cartilage 60 micron -v- 20 micron
100 micron in Placebo across total joint but 170 increase in iPPS
Small study size but still very encouraging that all sections of joint got positive effect.
PARA-012
400 subjects randomised 1:1 roughly
PBO - saline
Consistent with our P2 studies
MRI and x-ray, baseline at 6 months and day 365
Looking for durability and evidence of DM.
Summary:
Continuing to work with potential partners for
China South America and USA
Well advanced in some of the discussions but all are waiting on p3 clearance by usa
QUESTIONS
1. [Ryan - host]When do u expect to get FDA feedback?
Waiting for FDA to give us clearance on p3 program
Had a meeting back in Jan 10th, we explained to fda all the data and results from dosing study
FDA said we want us to put it into a final response.
18th April, since that time we have been waiting to ask us any q's or clearance with protocol design based in p2 data and dosing
We believe this will be our MED
2. [Ryan] do u envisage any q's or delays?
We know the fda is reviewing our package, they have asked us some procedural q's and links to some studies to clarify the data in a few areas.
We r well and truly prepared to answer any other qs
We don't know how many ore q's are to come
We believe our data submitted is v comprehensive, we would hope they would give us clearance within weeks from now.
We are hoping they will respond
3. [Ryan] talk us thru over lowering of participants in this stage
In our earlier stage our bio stat. determines our drug effect size, lets call it X
Second stage drug effect size was higher.
Median Drug effect size. When we apply this to the current data, it says we should get SS with a 98% success with 400 subjects, we don't need to do as many patients
4. Is the Co looking to add to board
Yes we look to see that the board has adequate skills we currently have two execs and non execs.
Our priority is to try and get the co working with fda to get go ahead.
Yes we are always looking for new members to board
Recent addition Matt F, has been outstanding so far.
Wealth of experience, knowledge and excitement in regards to commercial deals.
5. IF FDA gives us green light what can investors look forward to in back half of this yr
No. of updates, we hope to announce commencement of trial, first patient, and also interim analysis progress
We hopefully will have finalised commercial discussion They r waiting for clearance b4 final decision
This is a major hurdle before moving it forward to revenues Biggest risk from there will be execution risk. But we have already shown we have recruited for 120 sites, 600 subjects
For this study we need 400, so we have expertise and skills to execute on this study.
6. (Participants questions from this point)_ Rough idea of total funds required for p3?
Caveats, if fda need additional monitoring and screening will add to costsApprox $50 and $60 mil to execute in this particular P3 trial.
7 Does the company have cash or need a cash raise [to fund P3]?
We don't have cash on hand, 4c will show we have $20 milwe have funding gap, we hope to fill the gap
We hope a commercial deal will go a large way to fund this gap.We have said we would prefer non dilutive cash raise on market preference to fund via commercial deal
8. Is 50 to 60 USD?
Yes
9. Special access system still avail?
The SAS is still on going, we have changed it slightly, we were making it free of charge as long as they were willing to give assessment of the drug and follow up study.We have agreed with tga to recover costs of shipping and supply so there is change,Stock of drug is being monitored so we have enough stock for P3. We have more stock arriving soon, but it is being prioritised for our P3 Trial
Yes SAS is ongoing, It is now a fee based service
Limited stock but we will have more in near future.
10. What is revised estimate of NDA timetable/date?
That comes after p3.IF we start Day 1 they go out for a period of 404. Depends on recruitment rate.
So NDA we estimate around 2026, maybe early 2027. That's up for discussion with FDA as we work thru the current issues and factors which may require some ext. to this timetable.
We aren't that far away from generating our first revenue
11 IF results r as good as u suggest, why haven't we got a deal, best time is after P2
Good q, we have interested parties that r preparing term sheets, in reality, u want to know u have clearance for a p3. They don't want unspecified delays.Waiting for this clearance that's why we believe the funds made available after this it will be assist.
So we do have commercial interest, as a result of conferences we have commercial interest in South America. Same in China and USA.We have three regions looking to have a deal in.But naturally they will wait for US FDA before pen to paper
12. In terms of Tga , what sort of royalty could we expect on these sales?
We have made a submission to see if we qualify, most have been in cancer treatments, we hope they see OA as important indication.
Will take 12 months, provisional july/aug 2025 or so
Once we have that approval we will need to do a distribution deal locally with a pharma co in Aus. That's up to us to negotiate that gives us a royalty of between 10 and 20%. 20% royalty sales, there r close to 3mil people with OA in UAS, discount a back to around 2 mil multiplied by $2500.
Its 100's millions, maybe a billion, then 20% of that.
That gives the quantum but we cant give those figs until we chat to commercial dealer
13. Is there any way for a patient with OA to get the drug now?
Yes Sas scheme.
Has been some supply issues , we were restricting to docs as we wanted to make sure we had enough P3 program
14. When would the peer review be published?
It's not up to us, it's been filed, two manuscripts 005 and 008. They have been submitted to OA and Cartilage, that's up to editor to make decision, questions, clarify data and re-write then we would see. Hopefully sometime this yr, sometimes it can take longer than 6 months, we will just have to wait but they have been submitted.
We have done our piece of work and it has been submitted and now we wait for the journal
CONCLUDING REMARKS
A soon as we get clearance we will update the market, we hope it is not weeks and not months.
(20min delay)