MOZZ NOTES
Sure there was an element of rote reading, but some nice highlights throughout.
NFL Video, 18 month follow up, as I have said in the past, nothing like hearing from the front line.
Nice to also hear about some parties getting to the due diligence stage in regards to potential deals.
I'll include the below in case they aren't added to the website.
QUESTIONS
1. Appointment of CEO progress with relevant experience and potential of Large Pharma board seat.
Paul - Global search firm, second round interviews being conducted. Some candidates subject to 6 month notice periods. Hope to have CEO in Q2/3 of this year.
Chris - we are focused on CEO with a US Bio Tech background.
2. OA Phase 2B Peer review publication
Donna - Phase 2B, lot of data has been shared. This makes it challenging in terms of peer review though manuscript is prepared. We also have 008 study so it is likely we will have twin publications of these together.
Paul - FDA has reviewed the data from 2B. The agency wants to ensure there is a better than even chance of providing efficacy going forward.
Journals often look for novelty. We will try and time the next submission around 008 so that this novelty can be added to. Safety and efficacy has bene reviewed by FDA and shouldn't be worried
3. In relation to the TGA Provisional application, must PAR wait until the full data set from 008 is achieved before applying or can this be done at an earlier point? Is TGA Priority Application an option for PAR to utilise?
Donna - Interim -v- final data actually depends on what the interim data looks like. For TGA program, need something that's novel and a clear advantage. If we can see that advantage then after careful review we could go at that point. Otherwise we will need to wait for 12 month end point (full data set) which shows duration effect. It will depend on the data looks and what the strength is around synovial fluid analysis and duration feedback.
We will approach TGA as soon as we have a strong case.
4. Partnership Deal update
Paul - Inbound interest from Europe, Asia and USA. We have had initial discussions with deal shape and have had confidential discussions. Some of the companies have started DD utilising data room. 2nd half of this calendar year? Steering committee meets weekly to discuss this.
No precise date possible, depends on both parties. We are very hopeful.
5. When would co provide cash flow spend update
Paul - delay of 12 months FDA delayed our plans, extra monitoring from FDA, extra costs, revised budgets coming in from CROs.
Justin - lot of work done internally, but more work to be done on spend assumptions. Long clinical programs, multi site, currency and programs. Must ,manage complexity. Costs and run rate will be clearer as we progress. We are aware on interest in cash flow and burn and will kepe shareholders updated
6. How many Docs showing interest in SAS scheme in Aus
Donna - Over the years we have had a tonne of interest. Since we have opened this up as a pay for use program we have actually curtailed some of the activity to hone in on docs that have relevant skills and experience. We encourage Docs to offer the trials to the patients more so than SAS to avoid competition of the two programs in Aus. More sites to open as we progress.
Paul - Interest in SAS has bene high but PAR is not in the position of being able to advertise this program. This happens by word of mouth only.
We cannot communicate medical info to the patient but the Doc can contact PAR. Testament to the program in regards to take up. If we were able to advertise it would be a massive amount of Docs taking this program up, but due to restrictions of TGA we cannot advertise to patients or docs.
7. Why not seek separate funding partners on the other programs
Paul -That's what is happening, We have a number of companies that have interest in orphan disease as an example.
At the same time we are talking to commercial companies that have interest in OA. Then we have a few companies that are interested in knowing more about both.
We are not necessarily just presenting OA for commercial transaction.
FORMAL PART OF QUESTIONS
8. Does company have enough cash or is a raise required, if raise required will retail also be included?
Paul - Yes we would definitely consider retail holders. We are hoping to address any share shortfall using preferably a non dilute form.
9. Would NON executive be eligible for a LTI/STI
John - not a concern for the company
Paul - Executive role attracted historically the LTI/STI remuneration
Going forward you will not see these forms of remuneration.
Future remuneration for Paul under discussion. Accounting question
Paul - Director fees discussion
Incentives discussion
10. Is Helen's position justifiable
Discussion to justify
11. Is Amos's position justifiable
Discussion to justify
Do you plan to acquire any more shares from the company
Yes
12. Is John's position justifiable?
Discussion to justify
13. Remuneration question
Paul -We will address any gaps and we hear the concerns of shareholders
We will strike the right balance.
John - Remuneration committee is an active committee
<End of Meeting>
Notes: Not all words are exact/quotes, some interpretations used. DYOR
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