I attended the investor presentation in Perth today.
There were about 30 people, the room was almost full and I believe they expected less people.
As I said earlier the preso ran for ~1h, then ~30 minutes for Q&A and we spent another hour discussing various questions after the formal part. About 15 questions were asked (at Q&A)) which is a very good engagement from shareholders.
Overall, very well structured and delivered presentation that covered a lot of material.
No big news, but explains in details all the background and invisible work the company did in 2012 and doing in 2013.
It was great to see ML here in Perth and discuss the questions in person. But the real business reasons behind these investor updates are outlined on slide 21. Majority of PRR shareholders are based in Australia and they need to lay a foundation for upcoming CR, IMHO (it’s just a matter of when)
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1. CANVAS recruitment.
To date: 14 clinical centres are activated, 23 patients are randomised and 3 patients have been dozed.
Full recruitment by 2H CY 2014.
ML is confident they can achieve this timeline, they expect 0.5 patient per month in AU and US, and 1 patient per month in EU. Also there was a talk that the majority of patients will come from EU centres. Once the EU centres are initiated we should see a ramp up in the numbers.
2. Slow recruitment
The process is very complex and they don’t rush just for a sake to start it.
On one side all regulatory and ethics approval should be met, then the centres should be trained and aligned and it takes about 6 months between “patient is randomised” and “patient is dozed” (surgery and chemo are in between).
3. Funding, CR, JV and etc
This is a foggy area in ML answers. All these matters are price sensitive info and you won’t get clear replies.
Where possible (with new trials) they will pursue the grants, but it was stated that the company will need to ask shareholders for funds at some stage to continue the trials.
Partners, JV and etc: (check slide 20) all the deals require
- robust clinical proof of concept (CAN-003 results): waiting for the final data Dec 2013
- clear regulatory pathway: WIP
- manufacturing platform: established
They (partners) need robust data (along with other two points), otherwise the risk is too high. So this topic is for 2014.
IMHO, remember these deals are not quick to sign, it takes a while to fix the details + all the paper work
4. NASDAQ
That’s an interesting topic.
During the presentation it sounded like they will evaluate to close the listing, but we discussed it after the preso again and more correct is they will evaluate this program in terms of what’s the best way to manage/run it (from $ and shareholder perspective). Also need to mention Frankfurt listing is linked to US listing.
The cost of US listing is several hundreds of thousands a year, Frankfurt listing is few tens of thousands a year.
They don’t argue NASDAQ is a flop, but it’s too early to give up on this. There are some (minor) advantages of the US and German listings, but the $ burden is quite high for Prima.
5. Updates on CAN-003.
They don’t plan to release any more interim results. The main reason is they need 24 months of data for meaningful results (on average patients in 1st remission have 16-18 months of PFS) + there is extra cost to prepare interim data.
ICM final data are due in Q3 2013
CAN-003 PFS in Q4 2014
6. Not much new on the trials for other cancers (just what we have in the presentation on slide 15)
7. Oral HPV.
Prima funds the trial, the trial is in very early stage (mice patients). The decision will be made mid 2013 (whether to proceed with the funding or not).
8. MR sells shares
No real conspiracy. He bought a new house and tax obligations. It was just a coincidence he sold the shares around negative trial results for Stimuvax. MR notified the board in early December.
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Happy to answer any questions
I’m sure there were more things discussed, will post later if remember and other people form Melbourne, Sydney and Brisbane will add some more info.
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