Avid Bioservices Inc (CDMO)

[golfho]

2014 MILESTONES & EXPECTATIONS-APRIL
I did not post this for March because I wanted to see what March Madness would produce.
I have updated the format to reflect the current reality.

1 - SUNRISE TRIAL:
2 - FINANCE:
3 - IST’s:
4 - UPCOMING EVENTS:
5 - FUTURE TRIALS:
6 - LAWSUITS:
7 - COTARA PARTNRESHIP:
8 - DR. BREKKEN et. al. and KOL ANNOUNCEMENTS (PUBLICATIONS, EDITORIALS, PRESENTATIONS):
9 - NEW/UPDATED ANALYST COVERAGE:
10 - THE RETURN OF ANTI-VIRAL:


1 - SUNRISE TRIAL:
Since February’s update there were only 3 additional sites added. We now have 15 US sites. In the prior PII trial there were 24 US sites. Of the current 15 site, only 4 are the same as the PII trial, the other 11 are new sites. Maybe the new sites are more prestigious…

There’s no way that the trial will achieve its goal of completing enrollment by the end of 2015 at this leisurely pace. We are all expecting the start of trials in Europe and Asia.

I am still hopeful that the delay is associated with partnering negotiations. I, just like everyone else on the board am patiently awaiting this news. OK…Some are waiting patiently…

Chanting Om…helps…!!!

2 - FINANCE:
We currently have ~$79M in the bank. We have a preferred stock financing vehicle in place and the trusty ATM available. We are into the second quarter of this calendar year and everyone is hoping that a partnership will be announced. I hope that this will be announced some time between NOW and the next 6 months.

Management has been talking about partnerships and collaborations. They seem to be making a distinction between the two. My understanding is that in the business world these two words overlap significantly. However, in the biotech world it might imply that; partnerships are deals where one party provides the money and the other party provides the technology and collaborations are deals where it is more of a 50-50 split. Time will tell.


3 - IST’s:
Phase I/II Trial: IST of bavituximab in combination with sorafenib in patients with liver cancer
Several posters were disappointed with the information that was recently reported, I initially was as well. It contained a restatement of the PI portion of the trial and only gave an enrollment update for the PII portion of the trial. And then there was a MLV slip(?) about a May report/presentation. I currently believe that management is anticipating an ASCO abstract on this trial but 1- UTWS is the sponsor and as such is in control and 2- ASCO is the organization that determines what abstracts will be accepted, and when that news will be released. FWIW I think that someone at PPHM told MLV that it is anticipating an abstract at ASCO and MLV miss-interpreted that to mean a done deal. Note the denial by IR to a poster on this board. One last note; I have been monitoring the progress on the milestone chart and note that the bars for the ISTs are moving on the recently updated versions. It looks like this one may be fully enrolled or very close to it.

Phase Ib Study: IST of bavituximab in combination with carboplatin and pemetrexed in patients with previously untreated Stage IV NSCLC
Enrollment is complete and we may hear about this trial at ASCO as well.

Phase I Study: IST of bavituximab in combination with paclitaxel in patients with HER2-negative metastatic breast cancer
The interim data was reported at ASCO 2013. Will we get final data at ASCO 2014?

Phase I Study: IST of bavituximab in combination with capecitabine and radiation therapy in patients with advanced rectal cancer
Using the Pipeline milestone chart; it appears that enrollment may be complete. Could this be another ASCO release?

A Two-arm, Single Center Phase 1b Trial of Bavituximab Plus Ipilimumab in Advanced Melanoma Patients
I am looking forward to the start of this one.

Open-label, Single Arm, Tumor Imaging and Dosimetry Study of I-124 PGN650 in Advanced Solid Tumors
Using the Pipeline milestone chart; it appears that enrollment may be complete here as well. I have no idea as to where this would be reported but, I would love an update.

4 - UPCOMING EVENTS:

11th Annual BIO Asia International Conference April 8-9
An important business meet & greet opportunity…Go Steve W.


ASCO May 30 to June 3 2014 - Deadline for abstracts was 2-4-14
From their website
http://am.asco.org/frequently-asked-questions-0

“Notification regarding acceptance or rejection of abstracts will be sent by email to the first author in late March. The decision of the ASCO Scientific Program Committee and ASCO Leadership regarding acceptance and presentation of abstracts is final.”

This may be the mother of all ASCO's for PPHM.

5 - FUTURE TRIALS:
Again, I go back to Dia’s original list of possible immunotherapy combinations.
a.anti-CTLA-4 (Yervoy) (Done)
b.anti-PD-1 (pre-clinical reported @ AACR 2014)
c.anti-PD-L1
d.anti-TGF-b
e.anti-IL-10
f.GM-CSF
g.IFN-a
h.IL-2
i.Provenge
j.other vaccines
k.appropriate TKI
l.radiation plus androgen deprivation (pre-clinical on radiation reported @ AACR 2014)

This is where this will become very interesting…PPHM has now put out data on another (Anti PD-1) pre-in vivo clinical trial. But to date no mention of who’s PD-1…Merck…BMS…Novartis…??? However to me, this implies that there is cooperation with at least one of them. Why…because PD-1 and many others on Dia’s list are not available without the approval of the controlling BP.

At this time PPHM does not have sufficient funds to initiate clinical trials in multiple indications. This is where partnerships & collaborations come in.

6 - LAWSUITS:
The frivolous CA lawsuit will go away by May.
The CSM lawsuit is starting to get very interesting.

7 - COTARA PARTNERSHIP:
Nothing going on here.

8 - DR. BREKKEN et. al. and KOL ANNOUNCEMENTS (PUBLICATIONS, EDITORIALS, PRESENTATIONS):
There is a steady stream of data coming out that continues to bolster and garner the respect of the entire oncology world.

9 - NEW/UPDATED ANALYST COVERAGE:
HELLO…Is anybody out there…??? I had expected to see several New/Updates analyst report by now. I guess they are waiting for more clarity as to where the company will get the financial support it needs.

10 - THE RETURN OF ANTI-VIRAL:
(Keystone: HIV Pathogenesis - Virus vs. Host) reported on 3-9-14 to 3-14-14
This was a shocker (In a good way)…I thought that nothing was going on with viral.

Something worth repeating…

One final note:
Even though I don’t read every post it appears that there is an ongoing discussion on whether PPHM could go it alone and does management really want a deal.

IMHO, anyone that thinks that management doesn’t want a deal is ignoring reality. There is NO doubt that management had an agreement in principle with ABBvie in September 2012. We will never know the terms. The landscape for cancer therapy has changed significantly since that September and trying to calculate the price of a paradigm shifting market disrupting technology like Bavituximab is very difficult.

Regards
golfho