FOCUS ON 2016…
What did management tell us at the last CC…???
FOCUS ON 2016…
FOCUS ON 2016…
FOCUS ON 2016…
FOCUS ON 2016…
What should we be doing…????
FOCUS ON 2016…
FOCUS ON 2016…
FOCUS ON 2016…
Are you frustrated over the pace of development…???
Are you angered over the sabotage of the PII…???
Are you confounded over the lack of clarification WRT partner/collaboration …???
Is this the right investment for you…???
Here are my assessments of what has occurred to date this past (2014) year and my expectations going forward.
And more importantly…How I plan to handle them.
I expected an announcement on a partnership/collaboration in 2014. That did not occur and I have little expectation that it will occur in the next 3 or 4 weeks. Management has downplayed a partnership in the most recent CC.
What do we know for sure…???
PPHM has been involved in dozens of collaborations over the past 12 months. We have heard of only ONE additional.
We can speculate on some of the others by viewing slide #8 from the last Quarterly CC and reading Dia’s numerous “Catalyst-Potential News List” posts.
PS Receptors:
AxL: Genetech
TIM-1: Celldex
TIM-21: Hokkaido Univ.
Immunosuppressive Cytokines/Enzymes:
TGF-b: Acceleron, Sanofi, Isarna
IL-10: BMS, Takeda
IL-21: BMS, Centocor
IDO: NewLink, Incyte
Downstream Immune Checkpoints:
PD-1: BMS, Merck, AstroZeneca
PD-L1: Merck, BMS, AstroZenica
CTLA-4: BMS, AstroZenica
Site openings now exceed 150 sites for the SUNRISE trial and perhaps we might hear something like “Enrollment is on schedule” I’m not counting on that.
I created a spreadsheet called “SUNRISE Enrollment Projections” If anyone would like a copy I can PM it to you now that I’m a paying member. The results to date are:
1 - Current sites = 152
2 – I make three enrollment per site assumptions: One is; first patient enrolled within 2 month and an additional patient enrolled every 4 months there after per site. The second assumes 1 patient per site every 4 months. The third assumes 1 patient per site every 3 months
NOTE: In both previous PII trials for NSCLC we averaged MORE than 6 months per patient per site. At that pace we would not complete enrollment until August 2016
Implied results:
1 - Enrollment will be complete in the time frame of July to December 2015 based on the 3 assumption above and August 2016 based on historical data.
2 - If the first look-in is based on ~150 events it will occur around August-November 2015
3 - If the first look-in is based on ~200 events it will occur around September – December 2015
AND…
SO WHAT…???
The first thing I will do is lower my expectations going forward…And listen very closely to what management will be saying.
Let me state clearly that I do not, in any way, have lower expectations with respect to the ultimate ASTRONOMICAL value of the anti-PS platform. IT’S THE WHEN.
AND NOBODY KNOWS WHEN…NOT EVEN MANAGEMENT.
So…
What do I know?
1 – Dissemination of information to the scientific community on PS targeting and validation of the science continues. During calendar year 2015 we will hear more about the liver cancer trial and we will read the published data on the breast cancer IST.
2 – Clinicaltrials.com most recent updates still include the following:
A: Estimated Primary Completion Date: April 2015 for the PGN650 Imaging trial (Yep…3 years to recruit 12 patients)
B: Estimated Primary Completion Date: August 2015 for the Bavituximab plus radiation trial
C: Estimated Primary Completion Date: March 2016 for the combo Bavituximab/Yervoy. Because this is an open label test we might get an interim readout in 2015
So…
What am I speculating?
1 – You don’t have to be a rocket scientist to assume that partnering discussions are not following management’s original schedule. So what are some possible reasons?
A: A regional deal with one or more BP’s is a non-started for any BP.
B: The revenue split is still not satisfactory for both parties.
C: There are still questions on BP’s mind concerning the market potential of Bavituximab.
2 – What does the most recent shelf registration imply?
A: PPHM will fund additional late stage clinical trials in liver or breast or both.
B: PPHM will initiate clinical trials with some of the downstream immuno’s without a partner.
C: The shelf shares will be used to bring on a partner and bring in a significant amount of cash.
So…
What are my predictions?
I MAKE NO PREDICTIONS…
It’s silly to try. There are too many variables. The best I can do is speculate about the possibilities. Most of which are stated above.
What will I do…???
NOTHING RIGHT NOW.
What have I done…???
I am now a paying member of I-hub.
I have put several additional poster on ignore.
I have been all in and remain so.
The one thing that gives me occasional nightmares is the possibility of additional sabotage.
Now back too “What will I do?”
My wife and I spend the winters in Florida. I generally leave NY in mid October. This coming October I will change my schedule and will attend the ASM. For better or worst I suspect this one will be quite different.
Good luck to all.
Regards
golfho
