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One note before I get to the meat of the matter.
I’m not sure how the 12th trial site was identified but I am maintaining a spreadsheet comparing the previous trial sites with the new trial sites. The 12th site added was “Peregrine Pharmaceuticals Investigational Site - Savannah, Georgia, United States, 31404”
So currently there are two sites in Georgia as there were in the PII trial but they are not the same sites. The N.H. site was added as part of the 9 additional sites added in January. And, thank you nh for identifying the site in N.H. If anyone can identify a trial site in their state please post that info and I will replace “Peregrine Pharmaceuticals Investigational Site”. I will periodically post the spreadsheet (As soon as I find out how…!!!)
Spreadsheet Summary:
To date 2 sites are the same
5 are in new States and
5 are in the same States but in different cities
Now for the meat of the matter:
My investment approach WRT PPHM was and still is, to assess the risk and reward of this proposition and then determine whether the risk is worth the reward. Over the last 5 years I have posted and update these calculations to reflect my current view.
My last post on this subject was post #149723 in November and I still stand by those numbers.
“My final conclusion on this matter is this:
The chance of success in clinical trials is somewhere around 15% to 30%. I no longer consider that a high risk. There is little doubt in my mind that PPHM can produce a better than 3X or 7X multiple at this level (Monday’s close of $1.62 X3 = $4.86 to x 7 = $11.34)
I still stand by my 9-23-12 assessment.
I AM NOW OFFICIALLY DONE WITH THE RISK & REWARD PORTION OF THIS PROGRAM.”
I also addressed the rewards portion of the proposition with this:
“The broad oncology market numbers are the numbers that I used to determine the potential market for PPHM. In the future as these immunotherapies come into the market other drugs will lose market shares. I still believe that in 6 - 8 years Bavituximab can capture ~30% of the market so whatever total oncology number you use ($40B - $50B - $60B annually) I’m good with. In short I think that the market opportunity for us will remain about the same.”
I’ll expand on that a little. I’ll assume that the “total oncology market” will be at the lower number ~$40B. Bare in mind that some analysts see the immunotherapy oncology market alone as being worth ~$35B annually. For this example I will stick to the more conservative ~$40B X 30% = $12B annually. In order to establish an Enterprise Value for any entity you need to know certain financial information. For P/E you need to know what the profit margin is; we cannot determine that now. So I use EBITDA which is effectively gross income and I use a very respected institution (NYU) as a source for averages.
The website:
http://people.stern.nyu.edu/adamodar/New_Home_Page/datafile/vebitda.html
I selected the “Pharma & Drugs” category and it’s EV/EBITDA is 11.54 so now we take the estimated annual gross income of ~$12B and multiply by 11.54 and we get an EV of ~$138B. Let’s further assume that we get diluted to the full extent of the authorized shares of 325M the share price would be ~$424.00.
In summary, within 6 to 8 years the EV of Bavituximab alone would be worth ~$138B. That is one “BIG ENCHILADA©”. And YES…There is a statistical chance of failure of ~ 2 out of 3 to 6 out of 7.
So if you like the odds, place your bets. I did a while ago…In retrospect way to early…But I’m still all in.
So now the question of “How do we get there from here?”
Quite a few people have posted their predictions lately and some of those predictions are starting to rankle me a bit.
1- Some people seem to think that an acquisition/merger is eminent within the next month or two.
I don’t think that this is a very likely scenario as this would require a complete 180 degree change in management’s stated position. It would require a VERY significant offer from a BP that would satisfy my above calculations. If management accepted a lowball offer they would need to drive around for the rest of their lives is something like the Pope Mobil…Or hangout with Dart on his will guarded yacht.
2- Some people seem to think that management is positioning the company to go it alone.
I don’t see that as very likely as well because again, it would require a complete 180 degree change in management’s stated position. Management has stated several times that they would like to establish regional partnership/collaborations. Partnerships and collaborations are the only way that PPHM can obtain sufficient financing, influence and marketing to move this platform at a rapid enough pace. I think that they would like to remain independent until the true value of the IP is recognized and that IMHO is several years away.
I am looking forward to this Friday CC. hopefully they will shine some light on their plans. I also think that the March Madness science blitz will be a big needle mover.
I am hoping that the March 13th 2014 Society of Surgical Oncology Cancer Symposium presentation by Dr Yapp is not the only liver presentation this year.
I can’t wait for the publishing of the abstract titles for ASCO 2014 to confirm the MLV slip…And more.
Now…What to make of all this capital that was raised?
1- I think that a portion of it will be used to advance some of the pre-clinical immunotherapy combinations into PI/PII clinical trials. If this is a true collaboration I am expecting a 50% cost sharing and a 50% profit sharing.
NOTE: I am happy to hear that the first one of these will start to enroll this month. However, I get nauseous every time I think about the fact that it’s a single site trial at University of Texas Southwestern Medical Center. The same place that has been running several other IST’s for us…For years and years…!!! I hope and pray that the other immuno-trials will be multi-center and co-sponsored by a BP.
2- Clearly money must be set aside to continue to advance the SUNRISE trial. I think that there’s a 50/50 chance that a partner will emerge at the first look in but if not, I think that one will emerge before the trial ends. Why…? Because I feel strongly that the improvement that was observed in the PII trial will be duplicated.
3- Liver - I don’t think that any regulatory agency will ever support initiating a PIII trial without having completed the PI and PII…UNLESS UTSW produces interim data that is incredibility compelling. I’m not going to the bank with that one. I would love that but, I won’t bet on it.
So in summary, I am in the camp of those who think that; with a ~$80M to $85M war chest, data reported on some of the pre-clinical trials, March Madness, potential initiation of an addition immunotherapy combo trial and ASCO abstracts to be announced, we will be in a much better place. When? IMHO mid-year.
Oh…I forgot…Viral is back…!!!
About Sunrise, I understand that SK indicated that enrollment could be completed in less time than the original 2 year estimate. Of the 11 previous clinical trials sponsored by PPHM NONE came in under the original estimated time. ALL took longer. I’ll go with the track record on this one. One caveat…If after the first look in, the data looks compelling we could get that hockey stick enrollment.
OK, I’m done…It’s time for Wine…
Regards
golfho
I would like to add my voice to all that have expressed their condolences. May this outpouring of sympathy and love bring you strength and comfort. My she rest in peace.
Regards
golfho
I don't check on this board more than once or twice a day but...
Your post was one of the best knee slappers I've ever read.
Regards
golfho
Well now…
It’s been three and a half weeks since my hip replacement. I’m doing outpatient physical therapy, I’m no longer on pain meds and I have WAY to much time on my hands…!!!
Last month I posted my milestone & expectations for 2014. This is my first update:
Red represents new thoughts/revisions
Before I go on…I created a spreadsheet listing all of the previous NSCLC clinical trial sites (PII) to the current (PIII) sites. To date, only 2 sites are the same, 5 are in new States and 4 are in the same States but in different cities…My thoughts…I’m surprised that they are not enrolling in most of the former trial sites first. Could this slow down enrollment? I’ll keep you posted.
The Following were my initial expectations for the year:
1- The S-3/IB/Partnership
I am in agreement with those that see this event as a pathway to significant financing. The options are a BP, and IB or a hedge fund. IMHO, I think that we will find out soon. My gut feeling is that it’s not a BP yet. The terms of a partnership will be complex; there may be multiple partners and collaborations. The turn towards immunotherapies will require at least some PI & PII validation before any BP would be willing to part with enough money to satisfy us. An IB would be fine. If we get all or most of the $100M on the shelf, that would be a game changer. That would allow us to initiate several trials with the other immunotherapies. Perhaps a PIII liver, if warranted, or a PIII breast…and no ATM
Well ki$$ my a$$...They did it again…They ran the ATM and only raised an additional ~$16M - $20M through the preferred offering. WTF. However, they now have ~$80M in the coffers which is more than they ever had in their history.
There has been a lot of discussion on this board about a merger/acquisition. I don’t see that happening any time soon…WHY?
Because management has stated for several years now that their goal (Latest version) is to establish partnerships/collaborations in ex-US regions and maintain as much of the US market as possible for themselves. So in my view, the possibility of a merger/acquisition is currently remote and probably years away.
2- Liver cancer IST results/Regional Partnership
I assumed in my previous post that data would be presented in one of these two liver conferences
APASL on March 12 to 15 2014. Deadline for abstract was 11-29-13
From there guideline document:
www.apasl2014.com/assets/assets/Guidelines-and-Policies-09-12-2013.pdf
Notification of acceptance of abstract was “Early January”
EASL on April 9 to 13 2014. Deadline for abstract was 11-25-13
From there guideline document:
http://www.ilc-congress.eu/2014/abstracts/call-for-abstracts.html
Notification of acceptance of abstract was “Late January”
From the “Upcoming Events” we now know that the 3-13-14 Society of Surgical Oncology Cancer Symposium is where some info will be forthcoming. If you review the 4-4-12 AARC Abstract (YES THAT’S RIGHT NEARLY TWO YEARS AGO) the report was on the safety (PI) portions of the PI/PII trial and was a report on 9 patients. A review of the 3-13-14 Adam Yopp presentation indicates that the data will address pre-clinical mouse data and more PI data…NO DATA ON THE PII…WTF…2 years after the start of the PII portion of this trial and there is no data on efficacy? In retrospect using the IST mechanism may have been the low cost route but boy oh boy is there a big time to completion hit.
I still stand by this earlier statement.
In my view, this indication could be an entry into the Asian market. I would hope that it would be one of the top tier Japanese BP’s… Akeda, Otsuka, Daiichi, Sankyo, Astellas, and Eisa…I believe, the Japanese are very thorough in there DD…And more importantly…they have a sense of honorability…For what ever that is worth these days.
3- Oncology conferences
There are several IST’s and preclinical data that could be reported on in the following important upcoming conferences.
AACR April 5 to 9 2014 - Deadline for abstracts was 12-4-13
The deadline for submission of late-breaking abstracts was Monday, January 27
From their website we get:
http://www.aacr.org/home/scientists/meetings--workshops/aacr-annual-meeting-2014/abstracts.aspx
“PUBLICATION OF ABSTRACTS
To assist attendees in planning their schedule for the meeting, accepted abstract titles will be made available online beginning February 19. Abstract bodies will not be made available online until March 5, one month prior to the meeting. (Late-Breaking Abstracts will be made available on April 4, the day before the start of the meeting.) Abstracts that have been selected for inclusion in the AACR press program will be made publicly available at the date and time of their presentation, either at the meeting or an official AACR press conference.”
Can’t wait until tomorrow.
So by February 19 we can see if PPHM submitted any abstracts, and by March 5th or April 4th, we can read the body of the abstracts.
The following remains unchanged:
Again, I go back to Dia’s original list of possible immunotherapy combinations, and hope that at least some of these combinations will be reported on, at AACR 2014
a.anti-CTLA-4 (Yervoy) (Done)
b.anti-PD-1
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
ASCO May 30 to June 3 2014 - Deadline for abstract 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.”
The primary focus of this organization is presenting and disseminating clinical trial data. The following is a list of clinical trials that are ongoing. NOTE: they are all IST’s and as such, the sponsor is not PPHM and the sponsor must submit the abstracts. PPHM has no control over this.
Phase I/II Trial: IST of bavituximab in combination with sorafenib in patients with liver cancer
We know that the 3-13-14 Society of Surgical Oncology Cancer Symposium is where this will be reported and I assume no additional data will be presented at ASCO.
Phase Ib Study: IST of bavituximab in combination with carboplatin and pemetrexed in patients with previously untreated Stage IV NSCLC
From the clinical trial fact sheet we see:
Study Start Date: May 2011
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
So perhaps we won’t here about this until 2016 or 2017…Good Grief…!!!
Phase I Study: IST of bavituximab in combination with paclitaxel in patients with HER2-negative metastatic breast cancer
From the clinical trial fact sheet we see:
Study Start Date: January 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
The interim data was reported at ASCO 2013…Is it too early for final data?
Phase I Study: IST of bavituximab in combination with capecitabine and radiation therapy in patients with advanced rectal cancer
From the clinical trial fact sheet we see:
Study Start Date: August 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
So perhaps we won’t here about this until 2016…Good Grief…!!!
Open-label, Single Arm, Tumor Imaging and Dosimetry Study of I-124 PGN650 in Advanced Solid Tumors
From the clinical trial fact sheet we see:
Study Start Date: June 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
The last update to this trial was March 2013 where they added 3 additional trial sites all three are “Not Yet Recruiting”…As of today there has not been another update…
4- Right after a/the finance announcement I would like to see the initiation of several PI/PII trials with the other immunotherapies
I AM STILL WAITING FOR THE ANNOUNCEMENT OF THE START OF RECRUITMENT FOR THE YERVOY – BAVITUXIMAB TRIAL…!!!
5- Final dismissal of the class action lawsuit. As it turns out the plaintive can stretch this out until some time in May
6- CSM settlement should come this year. I can’t see this dragging out another year…But stranger things have happened.
7- Cotara partnership:
From the most recent 10-Q:
“Cotara – The increase in Cotara related expenses of $1,188,000 during the six months ended October 31, 2013 compared to the same period in the prior year was primarily due to an increase in manufacturing costs associated with preparing Cotara for potential later-stage clinical trials for the treatment of GBM combined with an increase in share-based compensation expense.”
I’m not getting my hopes up but…Wouldn’t be nice to see some progress.
8- Dr. Brekken et al and KOL announcements (publications, editorials, presentations)
We now know about and eagerly await our own “MARCH MADNESS”
9- New/Updated analyst coverage
I would have expected and update from this conference by now: Dec 3–4, 2013 - 25th Annual Piper Jaffray Healthcare Conference
We have the following coming up this quarter:
Feb 25–26, 2014 - RBC Capital Markets Healthcare Conference (NEW)
Mar 3–5, 2014 - Cowen & Co. 34th Annual Health Care Conference
Mar 9–12, 2014 - 26th Annual ROTH Conference
IF the financing is completed/clarified before anyone of the above conferences it could become very interesting around these parts…!!!
I mean…Verrrrrrryyy interesting.
10- Institutional ownership increase
As stated several time, many institutions cannot buy shares in a company whose share price is below $5.00…Not all but many. With all of the catalysts noted above I see this as very doable…within this or next quarter. It’s all about the financing.
Some final notes:
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
Not to be repetitious...
But...
Loof...
You may want to replace that...
Sputter...Sputter...
with something like...
Varooooommmm...
Just saying...
Regards
golfho
Bungler & CP;
Maybe my head is still foggy from the flu that I’m getting over but, I don’t understand this discussion.
When I wrote a post a week or so ago I stated that:
“1- anti-CTLA-4
Bristol-Myers Squibb - Yervoy (Ipilimumab) was approved by the FDA in March 2011 to treat patients with late-stage melanoma. Currently in trials for several other cancers.
As this is an approved mab there is no requirement to seek approval from Bristol-Myers Squibb. This is on the docket to start this month.
2- anti-PD-1
Merck – Lambrolizimab – Currently in multiple trials for multiple cancers.
Unlike Yervoy (Ipilimumab) this mab requires approval from Merck before PPHM can go to the FDA. Merck can approve or gum up the works until Lambrolizimab is FDA approved.
Bristol-Myers Squibb – Nivolumab – Currently in 6 late stage trials for Lung, Melanoma and Kidney cancer and multiple early stage trials vs. all solid tumors
The same applies to this candidate as applies to Merck – Lambrolizimab”
I stated that IMO, PPHM would need approval from Merck et. al. in order to use their mabs. I hold that opinion not because of any patent violation issue but because they are, to my knowledge THE SOLE manufacturer of their specific mabs and as such they have control over who uses them, prior to market approval.
The scenario would go like this:
PPHM: We would like to buy some of your Lambrolizimab.
Merck: WHY…?
PPHM: We are interested in testing it with our produce…We think there may be some synergies.
Merck: I’ll have to get back to you on that…
(Some time later)
PPHM: Well…???
Merck: We spoke to upper management…They’re not interested at this time…Maybe next year.
My point is; there is NOTHING that I know of that can compel any manufacturer to part with a produce if it chooses not to.
What am I missing…???
Regards
golfho
VERY WELL SAID...
And thank you for your continued thoughts
The time is near.
Regards
golfho
I'm Still feeling like crap...
BUT...
I Hear...
I thank all who have PM'ed me.
I'm to cheap to buy a full subscription...
Hmmmmmm....
Maybe after this quarter
Regards
golfho
The Following are my expectations for the year:
Before I start I would like to thank Dia76ca for starting this list. I have modified and grouped things in what I think might be the chronological order.
1- The S-3/IB/Partnership Thingie…
I am in agreement with those that see this event as a pathway to significant financing. The options are a BP, and IB or a hedge fund. IMHO, I think that we will find out soon. My gut feeling is that it’s not a BP yet. The terms of a partnership will be complex; there may be multiple partners and collaborations. The turn towards immunotherapies will require at least some PI & PII validation before any BP would be willing to part with enough money to satisfy us. An IB would be fine. If we get all or most of the $100M on the shelf, that would be a game changer. That would allow us to initiate several trials with the other immunotherapy’s. Perhaps a PIII liver, if warranted, or a PIII breast…and no ATM
2- Liver cancer IST results/Regional Partnership
As I pointed out in an earlier post, management has stated that interim data would be reported in this quarter. Here are my best two guesses:
Liver Conferences:
These are IMO the more important liver conferences that could fall into the timeframe of the stated goal of reporting on the IST liver trial.
APASL on March 12 to 15 2014. Deadline for abstract was 11-29-13
From there guideline document:
http://www.apasl2014.com/assets/assets/Guidelines-and-Policies-09-12-2013.pdf
Notification of acceptance of abstract is “Early January”
EASL on April 9 to 13 2014. Deadline for abstract was 11-25-13
From there guideline document:
http://www.ilc-congress.eu/2014/abstracts/call-for-abstracts.html
Notification of acceptance of abstract is “Late January”
I assume (and we all know how to spell ASSUME) that management will announce this with a PR and include it in “Upcoming Events”…But then again, one only has to glance at cjgaddy’s list of upcoming events and the company website, to note a significant disparity.
In my view, this indication could be an entry into the Asian market. I would hope that it would be one of the top tier Japanese BP’s… Akeda, Otsuka, Daiichi, Sankyo, Astellas, and Eisa…I believe, the Japanese are very thorough in there DD…And more importantly…they have a sense of honorability…For what ever that is worth these days.
3- Oncology conferences
There are several IST’s and preclinical data that could be reported on in the following important upcoming conferences.
AACR April 5 to 9 2014 - Deadline for abstracts was 12-4-13
The deadline for submission of late-breaking abstracts is Monday, January 27
From their website we get:
http://www.aacr.org/home/scientists/meetings--workshops/aacr-annual-meeting-2014/abstracts.aspx
“PUBLICATION OF ABSTRACTS
To assist attendees in planning their schedule for the meeting, accepted abstract titles will be made available online beginning February 19. Abstract bodies will not be made available online until March 5, one month prior to the meeting. (Late-Breaking Abstracts will be made available on April 4, the day before the start of the meeting.) Abstracts that have been selected for inclusion in the AACR press program will be made publicly available at the date and time of their presentation, either at the meeting or an official AACR press conference.”
So by February 19 we can see if PPHM submitted any abstracts, and by March 5th or April 4th, we can read the body of the abstracts.
Again, I go back to Dia’s original list of possible immunotherapy combinations, and hope that at least some of these combinations will be reported on, at AACR 2014
a.anti-CTLA-4 (Yervoy) (Done)
b.anti-PD-1
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
ASCO May 30 to June 3 2014 - Deadline for abstract is 2-2014
Abstracts are still being accepted.
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.”
The primary focus of this organization is presenting and disseminating clinical trial data. The following is a list of clinical trials that are ongoing. NOTE: they are all IST’s and as such, the sponsor is not PPHM and the sponsor must submit the abstracts. PPHM has no control over this.
Phase I/II Trial: IST of bavituximab in combination with sorafenib in patients with liver cancer
Management has stated that the results of this trial will be reported in the first quarter at a liver conference I assume that there will be no additional data that could be reported that this venue.
Phase Ib Study: IST of bavituximab in combination with carboplatin and pemetrexed in patients with previously untreated Stage IV NSCLC
From the clinical trial fact sheet we see:
Study Start Date: May 2011
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
So perhaps we won’t here about this until 2016 or 2017…Good Grief…!!!
Phase I Study: IST of bavituximab in combination with paclitaxel in patients with HER2-negative metastatic breast cancer
From the clinical trial fact sheet we see:
Study Start Date: January 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
The interim data was reported at ASCO 2013…Is it to early for final data?
Phase I Study: IST of bavituximab in combination with capecitabine and radiation therapy in patients with advanced rectal cancer
From the clinical trial fact sheet we see:
Study Start Date: August 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
So perhaps we won’t here about this until 2016…Good Grief…!!!
Open-label, Single Arm, Tumor Imaging and Dosimetry Study of I-124 PGN650 in Advanced Solid Tumors
From the clinical trial fact sheet we see:
Study Start Date: June 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
The last update to this trial was March 2013 where they added 3 additional trial sites all three are “Not Yet Recruiting”…As of today there has not been another update…
4- Right after a/the finance announcement I would like to see the initiation of several PI/PII trials with the other immunotherapies
5- Final dismissal of the class action lawsuit.
In my view this will be dismissed on the 22nd. From what I remember the plaintiff could file one more amendment but, if my memory serves me well the plaintiff cannot just reword or make the same points again. The amendment must contain new material…We’ll see soon enough.
6- CSM settlement should come this year.
I can’t see this dragging out another year…But stranger things have happened.
7- Cotara partnership:
From the most recent 10-Q:
“Cotara – The increase in Cotara related expenses of $1,188,000 during the six months ended October 31, 2013 compared to the same period in the prior year was primarily due to an increase in manufacturing costs associated with preparing Cotara for potential later-stage clinical trials for the treatment of GBM combined with an increase in share-based compensation expense.”
I’m not getting my hopes up but…Wouldn’t be nice to see some progress.
8- Dr. Brekken et al and KOL announcements (publications, editorials, presentations)
To date, from cjgaddy’s list of upcoming events we have:
Jan30: GTC’s “Novel Immunotherapeutics Summit 2014”, SanDiego http://tinyurl.com/kmlrkzk
…5:25pm: PPHM’s Bruce Freimark (Dir./ProdDev), “PS-Targeting Antibodies Enhances Activity of Immune Checkpoint Inhibitors and Re-activates Immune System in Tumors”
Mar12: ECCO’s 1st Immunotherapy of Cancer Conf., Munich http://www.ecco-org.eu/Events/ITOC1.aspx & http://tinyurl.com/lr6r23e
…ECCO = European CanCer Organization
…3-12-14 4:30pm: Joe Shan (VP/Clin+Reg), Plenary/Cancer Immunology: “Bavituximab: A Novel PS-Targeting Immunotherapy for the Treatment of Cancer”
Mar25 12-4pm: "NYAS Symposium on Lung Cancer”, NYC http://tinyurl.com/kr8k72w
…Dr. Rolf Brekken (UTSW, SAB/PPHM) one of 3 speakers, symposium titled, “Lung Cancer: Advances in Current Treatment Modalities & Patient Classification” – organizers include BI-Pharm, Forest-Res-Inst., George Zavoico
I would like to point out that they are all in the first quarter…More to come…???
9- New/Updated analyst coverage
I would have expected and update from this conference by now: Dec 3–4, 2013 - 25th Annual Piper Jaffray Healthcare Conference
We have the following coming up this quarter:
Feb 25–26, 2014 - RBC Capital Markets Healthcare Conference (NEW)
Mar 3–5, 2014 - Cowen & Co. 34th Annual Health Care Conference
Mar 9–12, 2014 - 26th Annual ROTH Conference
IF the financing is completed/clarified before anyone of the above conferences it could become very interesting around these parts…!!!
I mean…Verrrrrrryyy interesting.
10- Institutional ownership increase
As stated several time, many institutions cannot buy shares in a company whose share price is below $5.00…Not all but many. With all of the catalysts noted above I see this as very doable…within this or next quarter. It’s all about the financing.
Some final notes:
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 last September. We will never know the terms. The landscape for cancer therapy has changed significantly since last September and trying to calculate the price of a paradigm shifting market disrupting technology like Bavituximab is very difficult.
OT: Or somewhat off topic:
I started to think about the extended family this message board has become. Like any extended family there are characters of every hue. Some beloved, some rascals, some brilliant…Some not so much but, like most extended families we seem to always gather together again.
That is, gather together with few exceptions:
Jazzbeerman – I understand that he’s working for PPHM and can’t post
FTM – I miss the science input…
RRdog – Perhaps not MIA but his input on the S-3 would be interesting.
Im sure there are more but this post is getting too long already.
OK…One more note on the humorous side.
I grew up in a blue collar neighborhood in NYC. It was very much like an extended family as well and everyone, when we were growing up, was tagged with a nickname: Reptile (He had very red and freckled skin) Screw (Last name Scrzarrio) Peck (Pectorals - Always lifting weights) Fettz (Nobody knows where that came from…!!!)
I now submit:
Biopharm: Our very own Dick Tracy
CloakedProtector: Mistic Genius & Market Guru
Cjgaddy: The source of all that is written
Asmarterwookie: Master of the Morning Wake-up call
Any More…???
As you can tell, I’m not playing golf, I'm home sick…And I have way to much time on my hand…!!!
Regards
golfho
Happy New Year to all.
As I stated in my last post, I was just about to pack up for a cruise and returned on Christmas Eve day. During that time over 3500 posts were written. We had the 12-10-13 CC and the most important announcement in a very long time. Yep…the preferred stock registration.
I have listen to the CC webcast replay and read the transcript. It appears that we will be treading water for a little bit longer.
I am happy to see that we have started the NSCLC PIII trial.
I am in agreement with those that see the preferred stock filing as a pathway to significant financing. The options are a BP, and IB or a hedge fund. IMHO I thing that we will find out soon (Within the next few weeks; and maybe as early as Monday). My gut feeling is that it’s not a BP yet. (I would prefer it to be a BP but I don’t feel it in my bones) An IB would be fine. If we get all or most of the $100M on the shelf that would be a game changer. That would allow us to initiate several trials with the other immunotherapy’s and no ATM. More on that later.
What I have been waiting for, for a very long time, is the report on the liver trial. I believe that management has stated that interim data would be reported in this quarter. Here are my best two guesses:
Liver Conferences:
These are IMO the more important liver conferences that could fall into the timeframe of the stated goal of reporting on the IST liver trial.
APASL on March 12 to 15 2014. Deadline for abstract was 11-29-13
EASL on April 9 to 13 2014. Deadline for abstract was 11-25-13
As of this writing the PPHM Upcoming Events Calendar has not been updated. I hope that one of the above and the two most important conferences below will be turning points for us.
Oncology Conferences:
Will we have something new to report for these very important conferences?
AACR April 5 to 9 2014 Deadline for abstract 12-4-13
ASCO May 30 to June 3 2014 Deadline for abstract 2-2014
Too address Dia’s questions from last year with reference to the other immunotherapy’s and there potential synergy and availability with Bavituximab.
I NOW GO HERE WITH MAJOR TREPIDATION…WHERE’S FTM WHEN YOU NEED HIM…???
1- anti-CTLA-4
Bristol-Myers Squibb - Yervoy (Ipilimumab) was approved by the FDA in March 2011 to treat patients with late-stage melanoma. Currently in trials for several other cancers.
As this is an approved mab there is no requirement to seek approval from Bristol-Myers Squibb. This is on the docket to start this month.
2- anti-PD-1
Merck – Lambrolizimab – Currently in multiple trials for multiple cancers.
Unlike Yervoy (Ipilimumab) this mab requires approval from Merck before PPHM can go to the FDA. Merck can approve or gum up the works until Lambrolizimab is FDA approved.
Bristol-Myers Squibb – Nivolumab – Currently in 6 late stage trials for Lung, Melanoma and Kidney cancer and multiple early stage trials vs. all solid tumors
The same applies to this candidate as applies to Merck – Lambrolizimab
3- anti-PD-L1
Roche - MPDL3280A - MPDL320A – Currently in trials for multiple cancers
The same applies to this candidate as applies to Merck – Lambrolizimab
4- anti-TGF-b
Sanofi-Aventis – Fresolimumab – In early/mid stage testing for breast cancer & Glomerulosclerosis
The same applies to this candidate as applies to Merck – Lambrolizimab
5- anti-IL-10
Readily available commercially, but I have not had the time to research it with reference to its target and efficacy.
6- GM-CSF
Readily available commercially, but I have not had the time to research it with reference to its target and efficacy.
7- IFN-a
Readily available commercially, but I have not had the time to research it with reference to its target and efficacy.
8- IL-2
An immunosuppressive antibody…Should this be included in this list?
9- Provenge
Approved for prostate cancer…A one trick pony…!!!
But, PPHM could investigate this combo without Dendreon’s approval.
10- other vaccines
Don’t know
11- appropriate TKI
Don’t know
12- radiation plus androgen deprivation
This could be a possibility as it requires only FDA approval
May 2014 be the year of wealth for us PPHM holders
Regards
golfho
Dia76ca…
Thank you for this list of expectations…I have added my assessments below. FWIW.
1. Bavi Oncology partnership
I suspect that this will take more time than we hoped it would. The terms will be complex; there may be multiple partners and collaborations. The turn towards immunotherapies will require at least some PI & PII validation before any BP would be willing to part with enough money to satisfy us. Other combos with additional chemo’s, radiation and the immunotherapies need to be validated.
2. Liver cancer IST results
I can’t begin to tell you how disappointed I am with the slow enrollment. The trial started enrolling in November of 2010. The first and only time we heard about this trial was at AACR in April 2012. Let’s assume that they had the data on the 9 patients by January or February of 2012. That would imply that it took 13 to 15 months to treat and evaluate 9 patients. With a goal of recruiting 56 patients we may get only preliminary data by AACR or ASCO 2014 and final data in 2015. I pray I’m wrong.
3. Liver cancer partnership
I don’t think that there will ever be a partnership for a single indication. In my view there might be a regional partnership that includes all indications per regions.
4. Breast cancer IST results
See my response above in reference to the duration of the liver trial.
5. Breast cancer advancing in clinic
This, IMO should be advanced as soon as possible…OK…So why not…??? We have had other clinical trials for this indication that were very successful. Why no advancement in this indication? IMO it is an already crowded field with many competitors. I think that management made a strategic decision to go for the lower hanging fruit, indications that have the highest unmet needs.
6. Ambulance Chaser Lawsuit ended(completely!)
From your lips…To Gods ear.
Well to be frank; I don’t think that there is much doubt that this will be dismissed in January. I don’t think that there is much left undiscovered; however one cannot fully rule out, complete insanity on the plaintiffs part.
7. CSM settlement
This may drag on but IMO we will get some compensation…When & for how much…???
8. Betabodies preclinical.
To far away for now
9. Bavi plus other immunotherapies preclinical results...we already have some very interesting Bavi plus Yervoy preclinical results. But there is more to come. In recent presentations PPHM has mentioned 12 or more potential Bavi/immunotherapy combinations. That does not rule out the potential of a cocktail of several of these being used together. So far we have only seen some results from the Bavi/Yervoy preclinical combination...which is going into the clinic in January. Obviously there is a lot more news to come.
a.anti-CTLA-4 (Yervoy)
b.anti-PD-1
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
I think that the reason that we are initiating a clinical trial with Yervoy is the fact that; now that Yervoy is an approved marketed drug, any medical facility can purchase it with little restrictions. Those drugs that are in clinical trial will need approval from the sponsor and the FDA…That takes more time. So I expect that clinical trials will be initiated more quickly with currently FDA approved drugs.
10. Cotara partnership announcement
This is a great disappointment. At the end of the day I think that Cotara will be given away with the Bavituximab franchise for as much as management thinks it could fetch.
11. Bavi plus immunotherapy clinical trials.
See above comments to #9…
12. Dr. Brekken announcements(publications,editorials,presentations)
Looking forward to them as a continuing validation but, I have low expectation WRT share price.
13. Another Govt. deal for viruses
I hope so…But…It’s low on my list of expectations
14. BTA/AA
Always a possibility
15. Imaging data update
I have the same level of frustration with this trial that I have with the liver trial. IMO this should have been completed by NOW…!!!
16. New analyst coverage
Soon…We just need a catalyst.
17. Institutional ownership increase
See above comment
Final note for this year…
Tomorrow is my wife’s birthday…A significant birthday…!!!
On the 7th we will be leaving for a 16 day cruise to South America, so, I will not be able to monitor this board for nearly three weeks. I hope that the quarterly CC will produce some clarity. I will try to listen to the CC while onboard but the satellite feed is bandwidth limited.
Last but not least; I would like to wish everyone a very happy and healthy holiday season…
Hoping that this year is THE year…
Regards
Golfho
I’m not sure I fully understand your question below:
”One of your options using 200,000 (200M – My Edit) shares your est. value 13.33 billion with a share price of 66.65.
Early on in your analysis you mention a approval ratio of 15%-30%
Assuming you represented a buyer of PPHM out right would you offer somewhere between 15.00%-30% of 66.65 for the risk factor.”
But I will give it a shot…
Here are the parts of my post that I think you are referring to:
“What is the total Oncology market today?
From this:
www.prnewswire.com/news-releases/the-cancer-market-outlook-to-2014-competitive-landscape-market-size-pipeline-analysis-and-growth-opportunities-now-available-on-reportsandreports-87326377.html
We get a number like $47.7B…
Let’s just say that we capture ~30% of the market (Assumes that Chemo, Radiation must be in the formula) = $15.9B
That’s annual sales…
Even for a stodgy big Pharma with an EBTDA to PRICE ratio of 5 the enterprise value would be 5 X $15.9B = ~$79.5B
Now we go through the same silly exercise of discounting 20% per year…from 6-8 years from now...blah…blah…blah…
We get ~$13.33B to ~20.84B in market cap…!!!
We now have ~104M shares outstanding…Throw in options and round it up to ~150 shares outstanding (I know…I’m being very generous). Throw in the $150M shelf…That’s about 28M shares. Let’s say all those shares go to our partner/partners and round that up to a total outstanding share count of 200M. So divide the potential market cap by the number of shares outstanding you get…
At a market cap of ~$13.33B we get a share price of ~$66.65
At a market cap of ~$20.84B we get a share price of ~$104.20”
If I represented a buyer of PPHM out right I would offer the minimum amount that I thought I could get the IP for…!!!
If I, golfho, were to be selling PPHM I would demand/accept an offer of between $13.33B and $20.84B for the oncology IP and that price does not reflect the other assets of the company.
I don’t think that there will be a buyout any time soon. Why?
Management doesn’t want to sell now and BP’s are not willing to shell out that kind of money right now.
I think that a partnership is very doable but, the negotiations are very complex.
It seems that management now wants the US market all for itself; they are not talking about co-promoting any longer.
If they negotiate a partnership with more that one BP how will they divvy up the various regulatory entities and clinical trials per indication.
What about the future of Beta Bodies…
The list goes on...
(Oh…!!! And by the way, before I forget…yes sunstar “B” not “M”)
I have not updated my assessment yet because there are too many possibilities. But, in general term, I think if all goes well we can capture a big chunk of the very big oncology market.
OT…I try to respond to all posts directed to me in a timely fashion but I’m 66 years old now and my perspective and priorities have shifted over the years. When I started to invest in PPHM over a decade ago I thought that it would provide a path to an early retirement and a very comfortable life style. I am now retired. My wife and I are enjoying our retirement. We have a small apartment in NY and a small cottage about an hour from the City and we spend the winters in Florida. I work out 3 times a week and play golf 3 times a week. In the past I monitored this board every 10 minutes, now it’s once a day. I have no less interest in PPHM now than I did a decade ago…But nowadays…It’s Che sera, sera.
Happy Thanksgiving to all; stay well and stay healthy.
Regards
golfho
I wanted to really review my assessments prior to responding.
Before I address your question:
“In your opinion if successful would our value be greater than your last projection?”
I would like to address the issue of Risk & Reward again. In my March post I thought that for all intents and purposes it was put to rest. I wrote:
“My final conclusion on this matter is this:
The chance of success in clinical trials is somewhere around 15% to 30%. I no longer consider that a high risk. There is little doubt in my mind that PPHM can produce a better than 3X or 7X multiple at this level (Monday’s close of $1.62 X3 = $4.86 to x 7 = $11.34)
I still stand by my 9-23-12 assessment.
I AM NOW OFFICIALLY DONE WITH THE RISK & REWARD PORTION OF THIS PROGRAM.”
One of the things that keep me up at night is not having an answer to vexing questions. In my prior post when I assessed the risk I included factors such as financing, the reverse split, management skills, etc. I provided them in my earlier posts. Over time, as PPHM progressed these factor were reduced and for the most part risk stood at about the same level as the clinical success rate.
For many months now I have been convinced the PII NSCLC trial was messed with. That event has set this company back over a year and the fallout continues.
How does one factor that in? How do you calculate lost time and opportunity? What if there’s more road blocks ahead?
Hence all the vexing…!!!
Some additional thoughts on risk:
The $30M loan that we received in anticipation of an imminent partnership agreement was in my view a signal that the ATM was no longer needed. Partner funding and the loan would cover expenses going forward. The disaster caused a default with penalties and forced the use of the ATM at the worst possible time. We have suffered over 40M shares diluted; on December 9th we will get an update.
Two years age more or less RRdog posted what I call the “Imagine” post where he spelled out a scenario where PPHM would engage an IB and negotiate a ~$100M injection of fund into the company. These fund would eliminate the need for the ATM, fund additional trials and raise the image of management I was intrigued; but I could not get more details on this plan other than “It would be standard boilerplate stuff”. In addition Paul Lytle was characterized as absolutely paranoid.
I’m not a great fan of Paul but I fully understand his paranoia. I’m feeling that way as well.
Now, to answer your question in broad terms:
Immunotherapy is the new word of the decade. There are a lot of big boys wanting to play in that field. Bavituximab was first tested as a mono-therapy. It didn’t do well as a mono BUT it was discovered that chemo & radiation caused additional PS exposure and the combinations were synergistic. This lead to a series of PII clinical trials; some producing very good results. However over the 4-5 years that these trials have been underway, immunotherapy has stepped to the fore front. But in my view Bavituximab was always considered an immunotherapy albeit not alone. It will play the game of helper to all. Sadly the validation with the other immunotherapies is just beginning.
The broad oncology market numbers are the numbers that I used to determine the potential market for PPHM. In the future as these immunotherapies come into the market other drugs will lose market shares. I still believe that in 6 - 8 years Bavituximab can capture ~30% of the market so whatever total oncology number you use ($40M- $50M - $60M annually) I’m good with. In short I think that the market opportunity for us will remain about the same.
Regards
golfho
Thank you for your incredibly clear assessment...
Hi Stockharvest and welcome to the board;
I post very infrequently so you may not be familiar with my line of thinking; it is similar to yours in that I research stocks looking for opportunities that are good long term bets. I’ve been in this stock for over 12 years. Like many here, I invested in TLCN (Former PPHM) because of the promise of Cotara. It had orphan status in the US, it was going to go to China for lung cancer, Avid was going to manufacture tons of Cotara. In 2003 Mr. Swartz took over TLCN and merged it with PPHM. Peregrine owned the IP for Bavituximab. Bavituximab was in pre-clinical studies. There were safety concerns with the Cotara’s delivery system; through a government grant a new delivery system was developed and Cotara had to start again with a PI trial. Mean while Bavituximab has steadily progressed through many PI & PII trials in many indications…It has far surpassed Cotara in potential medical importance. Revolutionary, dare I say. Prompting me to refer to Bavituximab as the BIG ENCHILADA ©. It appears that management, with limited resources has moved Bavituximab as fast as possible while still trying to move Cotara along.
Most of my posts focused on two subjects:
The risks of this proposition
The possible rewards for this proposition
I’ll save you some time by reposting the Risk portion of my most recent assessment:
QUOTE:
__________________________________________________
Note: the latest and most definitive assessment of clinical trial failures was written by Joseph DiMasi from Tufts.
http://www.biotech-now.org/business-and-investments/inside-bio-ia/2010/11/clinical-trial-success-rates-recent-study-from-tufts#
More on the matter:
http://biostrategics.wordpress.com/2011/06/27/clinical-trial-probability-of-success-just-how-probable-is-a-great-outcome/
And still more on the matter:
http://insidebioia.files.wordpress.com/2011/02/bio-ceo-biomedtracker-bio-study-handout-final-2-15-2011.pdf
The above assessments place the probability of success for a biologic in oncology, that completed PII trial and needs to successfully complete a PIII and get FDA approval at (.34 X .8 = .272). Note that for NSCLC the success rate is 2%...!!!
_____________________________________________________
The reward portion of this proposition changes based on your individual entry point and the current price. In the assessment that I made on 9-23-13 (The day before BLACK MONDAY) I reasoned that at the current stock price ($5.39) the proposition still made sense.
QUOTE:
_____________________________________________________
In that post I set the risk factor at ~ 3:1. Newbies should read both posts. Think about it, you are given a one out of three chance of winning a bet, any bet. To put it another way; there is a roulette wheel, a roulette wheel with only three numbers. A one dollar bet on an even money bet would pay one dollar, that’s not a good bet, you have two chances to lose for every one chance to win. Now, if a dealer offered 2 dollars for a one dollar bet some people would say “wow I could double my money and make that bet”. If the dealer offered 3 dollars for your one dollar bet then that is a “true odds bet” for that 3 number roulette wheel. The odds are correct.
So, now let’s apply the simple logic to PPHM. If you purchased shares at $.40 a few months ago, when the shares arrived at $1.20, the proposition called “Investing in PPHM” satisfied the risk. Everything else is extra gravy. If you purchased shares at $1.00, when the share price arrived at $3.00,yep, you got it by now.
On Friday PPHM closed at $5.39. In order for the risk to be satisfied, the price has to be $16.17. That’s not to say that you can’t take the money and run at any price over $5.39. Taking money off the table is never a bad thing. The point I’ve been making is currently you should triple your money (Reward) in order to get paid correctly for the risk.
1- Let’s just assume that the first and only indication for Bavituximab is second line NSCLC. Management has indicated that that market might be worth 1B dollars annually. You can do your own research. When will that happen? Let’s just say in three to four years. (PIII + FDA review) So in 3 or 4 years the partnership could be looking at a revenue stream of ~$1B annually. At a 20% royalty PPHM could be receiving ~$200M in annual revenue. Even for a stodgy big Pharma with an EBTDA of 5 the enterprise value would be $1B, discount that at 20% per year to today yields a current value of…($1BX.8)X.8X.8X.8= $409M. The above does not include any up front money or milestone payments, nor does it include Avid revenue. That should be compared to today’s value of ~$561M. So, with only addressing the second line NSCLC and nothing else, PPHM is properly valued.
What is the reality of Bavituximab working in only one indication…?
IMO ZIP…!!!
It has already demonstrated efficacy in:
1. Ph.2 Bavi+Doce/BREAST/Refractory MOS=20.7mos
2. Ph.2 Bavi+PC/BREAST/Frontline MOS=23.2mos
3. Ph.2 Bavi+PC/NSCLC/Frontline MOS=12.4mos
It has completed and is awaiting results on the following:
1. Phase IIb Bavi+PC vs. Front-Line NSCLC
2. Phase II Bavi+GEM vs. Front-Line Adv. Pancreatic
There are 5 IST in process that will report over the coming few quarters:
1st IST Ph.I/II Trial (Bavi+Sorafenib vs. Liver Cancer/HCC, open-label)
2nd IST Trial (Bavi+Paclitaxel vs. Her2- Met. Breast Cancer, open-label Ph.1)
3rd IST Trial (Bavi+PemCarbo vs. Frontline NSCLC, open-label Ph.1B)
4th IST Trial (Bavi+Cabazitaxel vs. 2nd-Line PROSTATE(CRPC) Cancer, open-label Ph.1B/IIA)
5th IST Trial (Bavi+Capecitabine+RAD) vs. Rectal Cancer (Ph1, open-label)
OK now DD, AF, eric, et al, pay particular attention to the following:
Let’s pick a very large tentacle…
Bavituximab delivers…
It is what the hypothesis suggested…
Bavituximab targets PS and activates the immune system. Certain PS inducing components i.e. Chemo, Radiation, etc. enhance that effect. And…It is broad spectrum.
I shiver…
You should be shivering too…Maybe for different reasons…
In 6 to 8 years Bavituximab could be used in many…and I mean many…as in MOST cancers.
6 to 8 years is a long time…Many things can happen. One of those things is the reality that Bavituximab is real…
What is the total Oncology market today?
From this:
http://www.prnewswire.com/news-releases/the-cancer-market-outlook-to-2014-competitive-landscape-market-size-pipeline-analysis-and-growth-opportunities-now-available-on-reportsandreports-87326377.html
We get a number like $47.7B…
Let’s just say that we capture ~30% of the market (Assumes that Chemo, Radiation must be in the formula) = $15.9B
That’s annual sales…
Even for a stodgy big Pharma with an EBTDA of 5 the enterprise value would be 5 X $15.9B = ~$79.5B
Now we go through the same silly exercise of discounting 20% per year…from 6-8 years from now...blah…blah…blah…
We get ~$13.33B to ~20.84B in market cap…!!!
We now have ~104M shares outstanding…Throw in options (That’s for you Jakedude) and round it up to ~150 shares outstanding (I know…I’m being very generous). Throw in the $150M shelf…That’s about 28M shares. Let’s say all those shares go to our partner/partners and round that up to a total outstanding share count of 200M. So divide the potential market cap by the number of shares outstanding you get…
At a market cap of ~$13.33B we get a share price of ~$66.65
At a market cap of ~$20.84B we get a share price of ~$104.20
How does that compare to $16.17…?
The above does not include imaging, viral, R84, etc.
_____________________________________________________
MY 3-10-13 THOUGHTS ON PARTNERING:
QUOTE:
_____________________________________________________
Between then and today we have had the destruction and resurrection of the flagship NSCLC trial replete with intrigue, scandal and taint…Good grief…!!!
We have also received the preliminary results for the pancreatic caner trial that was not the homerun that we had hoped for.
The PPS has been taken to the wood shed and set upon with 2X4’s
And it appears that, whatever “letter of intent” signed with BP around September has been postponed, suspended or cancelled.
So now I will try to look forward and try to scope what a deal will look like and in what time frame.
I think that many of us thought that a tentative deal was agreed upon in September. The 2 new board members remark stands out. If this were a regional deal; how would a second partner fit in? Things start to get sticky…Not impossibly…Just sticky. Who’s the principal partner? Who’s the junior partner?
I’m a big fan of KISS (Keep It Simple Stupid)…So for now, I’ll go with a single partner.
What does PPHM want?
It seems to me that they are moving second line NSCLC as fast as possible, AA, Breakthrough Designation and a mid-PIII look into the trial. They floated a 600 patient trial…Does any company float a number for a PIII trial before and EOP2 meeting with the FDA? Is that a King miss-step? Or has Garnick already established some parameters with the FDA? They have reported preliminary results for pancreatic cancer and will report on the first line NSCLC within the next few months. Let’s not forget the previous signal seeking PII trials and the ISTs.
In my view the answer is; they want to initiate as many trials as they can and as quickly as possible. That’s a lot of money.
My back of the envelope:
~600 patient PIII trial for second line NSCLC ~$50M to $65M
~100 patient longer PII trial for pancreatic cancer ~$10M to $12M
~100 patient PII trial for prostate cancer ~$10M to $12M (If IST is successful)
~600 patient PIII trial for breast cancer ~$50M to $65M
~100 patient PII trial (With radiation) for rectal cancer ~$10M to $12M (If IST is successful)
~300 patient PIII trial for liver cancer ~$30M to $36M (If IST is successful)
Approximate trial cost for the above 6 trials = ~$160M to $202M spread over the next 4-6 years.
The company has an accumulated debt from inception of approximately $338M. I’ll SWAG the Bavituximab portion at ~40%, ~$132M. I will also assume that the company will want to get seed money for viral and imaging. ~$20M to $30M…???
So my back of the envelope SWAG gets me to ~ $312M to $364M in upfront and milestone payments. In addition a 20% to 25% royalty on sales. I would love to see them get co-promotion in the US as well.
My timeframe for the start of a revenue stream is ~4 years from now. That would be ~first quarter 2017. With AA or Breakthrough Designation that could be as early as first half on 2014.
Cotara in my view is on the back burner, management stated at the Cowen conference that first half of 2014 was their new partnership goal. I don’t think that there is much BP interest. Bavituximab is the word. I will restate my assessment of Cotara from 2 years ago:
“4- The terms of any partnership agreement.
If I am correct in my assumption that the company walked away from the R & R deal of ~ $35M, one would expect that any deal will be for a higher up front amount. The R & R deal did not state a royalty amount. I will go with LTC’s 20%. So, what is a reasonable up front amount? IMO, it should include the full cost of the PIII trial, in addition it should include a fair amount of the development costs. (Does anyone have any knowledge in this area?) In addition, it may include perhaps, a lump sum figure representing a portion of the annual market.
My SWAG…Trial cost ($24M to $37M) + Prior development cost ($20M to $30M…???) + Lump sum ($35M to $70M…???) = $79M to $137M”
And of course, there is always a possibility that Bavituximab and Cotara could go to a single partner.
I would hope that they could conclude a partnership agreement before the annual shareholders meeting.
________________________________________________________
In conclusion; I stand by my assessment. I’m not sure that there will be any partnership deal signed before the end of FY CC in mid July but I still hope that things can be concluded before the mid-October Annual Meeting.
Regards
golfho
Wordy...But Wonderful...
Regards
Golfho
Thank you...
That pretty much sums up my view as well.
Regards
Golfho
Thank you...
May you have, along with all of us, a healthy and happy future
Regards
Golfho
There are a few points I would like to make:
Finance:
The value of AVID:
I’ve gone over this several different times and used several different assumptions. Here are my latest thoughts and assumptions:
The Enterprise Value (EV) will be determined as it relates to the total PPHM EV and not how it would be valued if it were to be sold.
There is some difficulty in determining the EV/EBTIDA for AVID. AVID is a CMO and PPHM is a Biotechnology company. The most inclusive list that I have found is this one:
http://people.stern.nyu.edu/adamodar/New_Home_Page/datafile/vebitda.html
The sector that I thing AVID fits into the best is “DRUGS” with 223 firms listed and an EV/EBITDA of 8.93.
If you chose too, there is a link in the above website that allows you to download the full list of firms.
NOTE: The Biotechnology list of 214 companies with an EV/EBITDA of 22.46 includes…PPHM.
Management has indicated that AVID’s revenue could exceed $20M this FY so I will use the range of $20M to $22M for my calculations.
On Thursday the EV of PPHM @ $1.33 per share was ~$182.4M
AVID’s EBITDA this year is projected to be between ~$20M & $22M X 8.93 = ~$178M to $196M…
So…as of Thursday AVID’s contribution to the EV of PPHM is…100% of PPHM’s value…The IP is valued at…Zilch, nada, zippo, niente, niets, nichts, rien…Got it…???
If PPHM were valued using the Biotechnology sector EV/EBITDA of 22.46 and AVID’s revenue, then PPHM should be valued at: ~$20M & $22M X 22.46 = ~$449M to $494M
That is fairly close to the value before Sept. 24th
This, in my view, speaks loudly to what RRdog and many others on this board have stated…There is a disconnect between the value of PPHM and its current price.
What are the negative factors weighting on PPHM:
1- The gold standard PII trial “Tampering” causing the results to appear less impressive. (To the untrained eye)
2- The delay of that trial.
3- The potential impact on FDA PIII approval
4- The potential impact on AA and BTD
5- The impact on partnering talks
6- The minimal results of the pancreatic cancer trial (To be clarified later)
7- The need for additional capital (Dilution)
ALL OF THE ABOVE DOES NOT BRING THE IP TO ZERO…!!!
Here are my thoughts on dilution, capital needs & burn rate.
From the latest CC & 10-Q we know that the company had ~$26.2M on 1-31-13 and added another ~$4.8M as of 3-12-13…That’s `$31M less expenditures from 1-31-13 to 3-12-13. I calculate expenditures to be ~$27M to $33M for this current FY. That averages out to ~$2.25M to $2.75M per month (1.4 X $2.25M to $2.75M) = ~$3.15M to #3.85M
Leading me to conclude that at the time of the CC PPHM had ~$27.15M to $27.85M…OK…OK…There is a possibility that revenue was also realized during that period…Geez…!!! This is how engineers drive themselves crazy…!!!
Going forward I will use quarterly numbers.
As of 1-31-13 cash on hand $26.2M
Plus equity sales $4.8M
Plus AVID revenue 4th quarter $3M to $5M
Minus expenditures $6.75M to $8.25M
Estimated cash on hand end of FY $25.75M to $29.25M
The above estimate of $25.75M to $29.25M compared to all of the previous cash on hand, for the last 3 years, of between $16.5M (7-31-11) to $26.2M (Most recent quarter)implies to me that the company may be very close to eliminating the “Going Concern” clause in the next 10-K…You heard it here first…!!!
The burn rate:
I can see no reason for the burn rate to increase dramatically for the next quarter or so. Expenditures should remain relatively flat and AVID revenue will continue to be lumpy but in my view, increase on an annual basis.
Partnerships:
This is what I think happened. A BP and PPHM were close to an agreement in September. What I mean by that is I think that they agreed in principal to a range of up front money and royalties. Then the second line NSCLC implosion occurred, followed by a, not overwhelming, pancreatic trail results that gave the BP an opportunity to “adjust” their numbers; to which PPHM replied…No thank you.
I believe that this is why PPHM is re-pursuing the regional concept. Interesting game of chicken…No…???
There was a fair amount of discussing concerning the question from George Zavoico during the CC about post treatment of the first line NSCLC after the trial and how that might affect the results of the trial. In my view; as stated in an earlier post; that it was my opinion that this issue is an issue for every trial that has survivors…So why the question…From someone that is very familiar with clinical trials…IMHO it was to preempt the critics if great results were reported.
Alas…
It’s Easter Sunday…
And the wine has been uncorked…
So I end this post here…
By wishing everyone a Happy Easter, Happy Passover…Happy to all things…
Good health to you Karkonos and everyone on this board.
Regards,
Golfho
People…People…People…There has been some speculation since the last CC about George Zarvoico’s question about post treatment of patients in the Bavituximab trial…On casual observation one would conclude that that is in fact standard operation procedure. Why would any doctor advise any patient to forgo addition treatment after a clinical trial? Why would anyone reasonably conclude that prior to the Bavituximab trial ALL first line clinical trials were followed by NO further treatment or intervention? This line of reasoning confounds me. Georges’ question is interesting…But…In what context…Mitigating a bad result…??? Preempting an attack on good results…??? Since my last post over 1000 post have been posted. I agree with RRdog…Much of the stuff that has been posted, is drivel. Such is life. People will discuss things that are interesting to them. In the absents of substance, an active mine focuses on pure speculation and fantasy.
I will now conclude the consumption of a very nice Alexander Valley Cab.
RRdog:
“Zavoico, in the Q and A of the qtrly cc raised the question of clinical trial patients living longer and taking additional treatment thus tainting the OS (overall survival) measurement. If a trial could be designed that would prevent patients from taking other treatment or at least measure subgroups that did not take additional treatment or limited treatment then we could get a clear look at extended response or "immunity" without the FDA feeling the result was adulterated by other drugs.
The idea is to validate any immunological response or MOA. This is a whole level up in the bavi story.”
Regards
Golfho
It was in the PR...
"In addition, Peregrine is continually evaluating its IST program based on a number of factors, including changes in the standard of care of patients and trial enrollment. Following a recent review of the ongoing IST studies, a Phase I/II IST evaluating bavituximab combined with cabazitaxel in patients with second-line castration resistant prostate cancer was discontinued due to slow enrollment and the approvals of two new oral drugs for the same indication which are changing the standard of care treatment for these patients. Peregrine will continue to evaluate proposals for ISTs as part of its overall program to assess new indications and combinations based on the broad potential of bavituximab."
Regards
Golfho
Prostate IST is out...
You're correct sunstar...
the $47.7B oncology market quoted in the link I posted was the market in 2008. I think that the GlobalData projections are newer. The link I provided was a summary of a report by ReportsAndReports from 2010. I did not want to pay for the report so I used the info provided in the summary. $90B by 2015...WOW...I need to double my estimate...
I shiver...
Regards
Golfho
I agree...EOM
Golfho
I'm humbled...
Golfho
I posted my most recent assessment on the risks and rewards of investing in PPHM on 9-23-12…My post #93907
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79844801
It’s a classic…!!!
I started that post with the following:
“Sometimes I shock myself…
With my own brilliance…
OK…
Going forward I promise not to, ever again, display such hubris…!!!”
I now post the following with the UTMOST HUMILITY, mouse like in voice and posture…obsequious in tone, and as always…IMVVVHO (Very, very, very)
In that post I stated the following about the risk:
“After that post I reassessed the risk factor again. My post # 73105”
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=70249933
“In that post I set the risk factor at ~ 3:1. Newbies should read both posts. Think about it, you are given a one out of three chance of winning a bet, any bet. To put it another way; there is a roulette wheel, a roulette wheel with only three numbers. A one dollar bet on an even money bet would pay one dollar, that’s not a good bet. Now, if a dealer offered 2 dollars for a one dollar bet some people would say “wow I could double my money and make that bet”. If the dealer offered 3 dollars for your one dollar bet then that is a “true odds bet” for that 3 number roulette wheel. The odds are correct.
So, now let’s apply the simple logic to PPHM. If you purchased shares at $.40 a few months ago, when the shares arrived at $1.20, the proposition called “Investing in PPHM” satisfied the risk. Everything else is extra gravy. If you purchased shares at $1.00, when the share price arrived at $3.00, yep, you got it by now.
On Friday PPHM closed at $5.39. In order for the risk to be satisfied, the price has to be $16.17. That’s not to say that you can’t take the money and run at any price over $5.39. Taking money off the table is never a bad thing. The point I’ve been making is; currently you should triple your money (Reward) in order to get paid correctly for the risk.”
Note: the latest and most definitive assessment of clinical trial failures was written by Joseph DiMasi from Tufts.
http://www.biotech-now.org/business-and-investments/inside-bio-ia/2010/11/clinical-trial-success-rates-recent-study-from-tufts#
More on the matter:
http://biostrategics.wordpress.com/2011/06/27/clinical-trial-probability-of-success-just-how-probable-is-a-great-outcome/
And still more on the matter:
http://insidebioia.files.wordpress.com/2011/02/bio-ceo-biomedtracker-bio-study-handout-final-2-15-2011.pdf
The above assessments place the probability of success for a biologic in oncology, that completed PII trial and needs to successfully complete a PIII and get FDA approval at (.34 X .8 = .272). Note that for NSCLC the success rate is 2%...!!!
Whatever risk factor you chose, 30%, 27%, 2% or any number you calculate; the inverse of that number is the multiple you need to achieve.
I also made some reward calculations in that post:
“In 6 to 8 years Bavituximab could be used in many…and I mean many…as in MOST cancers.
6 to 8 years is a long time…Many things can happen. One of those things is the reality that Bavituximab is real…
What is the total Oncology market today?
From this:
www.prnewswire.com/news-releases/the-cancer-market-outlook-to-2014-competitive-landscape-market-size-pipeline-analysis-and-growth-opportunities-now-available-on-reportsandreports-87326377.html
We get a number like $47.7B…
Let’s just say that we capture ~30% of the market (Assumes that Chemo, Radiation must be in the formula) = $15.9B
That’s annual sales…
Even for a stodgy big Pharma with an EBTDA to PRICE ratio of 5 the enterprise value would be 5 X $15.9B = ~$79.5B
Now we go through the same silly exercise of discounting 20% per year…from 6-8 years from now...blah…blah…blah…
We get ~$13.33B to ~20.84B in market cap…!!!
We now have ~104M shares outstanding…Throw in options and round it up to ~150 shares outstanding (I know…I’m being very generous). Throw in the $150M shelf…That’s about 28M shares. Let’s say all those shares go to our partner/partners and round that up to a total outstanding share count of 200M. So divide the potential market cap by the number of shares outstanding you get…
At a market cap of ~$13.33B we get a share price of ~$66.65
At a market cap of ~$20.84B we get a share price of ~$104.20
How does that compare to $16.17…?
The above does not include imaging, viral, R84, etc.”
My final conclusion on this matter is this:
The chance of success in clinical trials is somewhere around 15% to 30%. I no longer consider that a high risk. There is little doubt in my mind that PPHM can produce a better than 3X or 7X multiple at this level (Monday’s close of $1.62 X3 = $4.86 to x 7 = $11.34)
I still stand by my 9-23-12 assessment.
I AM NOW OFFICIALLY DONE WITH THE RISK & REWARD PORTION OF THIS PROGRAM.
The thing I will focus on in the near future is the deal that management can conclude and when.
In my 9-23-12 post I wrote:
“Management is looking to put together a deal that includes regional partnerships and co-promote the U.S. market. I don’t think that there could be more than 2 regional deals, The E.U. and Asia (and I would think that Asia would include all of the APEC nations), but you never know. The issue with that would be; how do you co-promote with 2 or more partners? 50-25-25 split? 33-33-33 split? 25-25-25-25 split? Will that be palatable for the partners? I could see how that would benefit PPHM, but will PPHM be able to convince 2 or more BPs that that is in everyone interest? Another possibility is that a single PB would take the world and co-promote in the U.S. Another possibility would be a partnership with the newly formed consortium…That would be interesting. What if a BP was greedy and wanted the BIG ENCHILADA© for itself?”
At the Cowen conference Mr. King stated the management was looking at Having a partner/partners onboard by/before the start on a PIII trial near year end. I’m disappointed but not surprised. I wonder if the “co-promote in the US” is still in play; I hope so.
I also wrote the following. The assumption on 9-23-12 was that we had a tentative agreement. We all know what happened on the 24th but I am reposting a part of that post because it addresses the issue of what we, management and the BP faces in framing a contract.
“Let’s just assume that the first and only indication for Bavituximab is second line NSCLC. Management has indicated that that market might be worth 1B dollars annually. You can do your own research. When will that happen? Let’s just say in three to four years. (PIII + FDA review) So in 3 or 4 years the partnership could be looking at a revenue stream of ~$1B annually. At a 20% royalty PPHM could be receiving ~$200M in annual revenue. Even for a stodgy big Pharma with an EBTDA to PRICE of 5 the enterprise value would be $1B, discount that at 20% per year to today yields a current value of…($1BX.8)X.8X.8X.8= $409M. The above does not include any up front money or milestone payments, nor does it include Avid revenue. That should be compared to today’s value of ~$561M. So, with only addressing the second line NSCLC and nothing else, PPHM is properly valued.
What is the reality of Bavituximab working in only one indication…?
IMO ZIP…!!!
It has already demonstrated efficacy in:
1. Ph.2 Bavi+Doce/BREAST/Refractory MOS=20.7mos
2. Ph.2 Bavi+PC/BREAST/Frontline MOS=23.2mos
3. Ph.2 Bavi+PC/NSCLC/Frontline MOS=12.4mos
It has completed and is awaiting results on the following:
1. Phase IIb Bavi+PC vs. Front-Line NSCLC
2. Phase II Bavi+GEM vs. Front-Line Adv. Pancreatic
There are 5 IST in process that will report over the coming few quarters:
1st IST Ph.I/II Trial (Bavi+Sorafenib vs. Liver Cancer/HCC, open-label)
2nd IST Trial (Bavi+Paclitaxel vs. Her2- Met. Breast Cancer, open-label Ph.1)
3rd IST Trial (Bavi+PemCarbo vs. Frontline NSCLC, open-label Ph.1B)
4th IST Trial (Bavi+Cabazitaxel vs. 2nd-Line PROSTATE(CRPC) Cancer, open-label Ph.1B/IIA)
5th IST Trial (Bavi+Capecitabine+RAD) vs. Rectal Cancer (Ph1, open-label)”
We now know the MOS for the pancreatic cancer trial and are now awaiting the details.
I then followed the above with the following:
“So, now that we have taken the little tentacle and the big tentacle out of the knot, what do we have? What are management and a potential partner/partners looking at? How do they structure a deal?
Sometimes the simplest solutions are not immediately obvious. Let’s state the problem in its’ simplest terms
You need to price a technology that is still unknown. It could yield a tremendous amount of money or be a bust. That is why a buy out at this point probably won’t work, too much risk for the BP. So, an incremental approach seems the most logical approach. PPHM receives up front money for second line NSCLC and milestone payments at various stages of progress. In addition PPHM receives seed money to advance other indications. PPHM receives milestone payments with every new indication that is advanced. At some point viral is revisited, imaging comes online.
At some point, the hypotheses that Bavituximab is truly a broad spectrum therapeutic that “Reactivates the innate and adaptive immune responses” will be validated.”
Between then and today we have had the destruction and resurrection of the flagship NSCLC trial replete with intrigue, scandal and taint…Good grief…!!!
We have also received the preliminary results for the pancreatic caner trial that was not the home-run that we had hoped for.
The PPS has been taken to the wood shed and set upon with 2X4’s
And it appears that, whatever “letter of intent” signed with BP around September has been postponed, suspended or cancelled.
So now I will try to look forward and try to scope what a deal will look like and in what time frame.
I think that many of us thought that a tentative deal was agreed upon in September. The 2 new board members remark stands out. If this were a regional deal; how would a second partner fit in? Things start to get sticky…Not impossibly…Just sticky. Who’s the principal partner? Who’s the junior partner?
I’m a big fan of KISS (Keep It Simple Stupid)…So for now, I’ll go with a single partner.
What does PPHM want?
It seems to me that they are moving second line NSCLC as fast as possible, AA, Breakthrough Designation and a mid-PIII look into the trial. They floated a 600 patient trial…Does any company float a number for a PIII trial before and EOP2 meeting with the FDA? Is that a King miss-step? Or has Garnick already established some parameters with the FDA? They have reported preliminary results for pancreatic cancer and will report on the first line NSCLC within the next few months. Let’s not forget the previous signal seeking PII trials and the ISTs.
In my view the answer is; they want to initiate as many trials as they can and as quickly as possible. That’s a lot of money.
My back of the envelope:
~600 patient PIII trial for second line NSCLC ~$50M to $65M
~100 patient longer PII trial for pancreatic cancer ~$10M to $12M
~100 patient PII trial for prostate cancer ~$10M to $12M (If IST is successful)
~600 patient PIII trial for breast cancer ~$50M to $65M
~100 patient PII trial (With radiation) for rectal cancer ~$10M to $12M (If IST is successful)
~300 patient PIII trial for liver cancer ~$30M to $36M (If IST is successful)
Approximate trial cost for the above 6 trials = ~$160M to $202M spread over the next 4-6 years.
The company has an accumulated debt from inception of approximately $338M. I’ll SWAG the Bavituximab portion at ~40%, ~$132M. I will also assume that the company will want to get seed money for viral and imaging. ~$20M to $30M…???
So my back of the envelope SWAG gets me to ~ $312M to $364M in upfront and milestone payments. In addition a 20% to 25% royalty on sales. I would love to see them get co-promotion in the US as well.
My time frame for the start of a revenue stream is ~4 years from now. That would be ~first quarter 2017. With AA or Breakthrough Designation that could be as early as first half on 2014.
Cotara in my view is on the back burner, management stated at the Cowen conference that first half of 2014 was their new partnership goal. I don’t think that there is much BP interest. Bavituximab is the word. I will restate my assessment of Cotara from 2 years ago:
“4- The terms of any partnership agreement.
If I am correct in my assumption that the company walked away from the R & R deal of ~ $35M, one would expect that any deal will be for a higher up front amount. The R & R deal did not state a royalty amount. I will go with LTC’s 20%. So, what is a reasonable up front amount? IMO, it should include the full cost of the PIII trial, in addition it should include a fair amount of the development costs. (Does anyone have any knowledge in this area?) In addition, it may include perhaps, a lump sum figure representing a portion of the annual market.
My SWAG…Trial cost ($24M to $37M) + Prior development cost ($20M to $30M…???) + Lump sum ($35M to $70M…???) = $79M to $137M”
And of course, there is always a possibility that Bavituximab and Cotara could go to a single partner.
I would hope that they could conclude a partnership agreement before the annual shareholders meeting.
Good luck to all.
Regards
Golfho
Thanks...EOM
Hi All...
A month or so ago someone posted a list of BP's that could be partner candidates and some reasoning for each. I can't seem to find it. Could you please re-post or point to that post?
Thanks in advance.
Regards
Golfho
I don't think that there is any reason to code anything in an open label trial...
Regards
Golfho
Funny...
No one else picked that one up yet...
Thanks for keeping things straight.
Regards
Golfho
Well Sir…
I normally do not get involved in other peoples debates. And in my view CP is quite good at defending his position. However I have a cold and today’s weather is preventing me from doing what I prefer to do (Golf) so I will spend some time responding to your (And by extension AF, DD et al) post and opinions.
Let me see if I can help you…
“CP.. I speak the truth.”
TBD
“I have followed this stock for many years.”
To me that would imply that you are familiar with biotech stocks and therefore understand the nature of the beast. Biotech’s fail far more often than they succeed. It takes sometimes decades to bring a drug through the clinical trial gauntlet. If you have followed “this stock” you should know that the next few months could be transformational.
“If Bavi is a viable cancer treatment for multiple indications then why is the stock at $1.20 after a 5 for 1 reverse split?”
If you “have followed this stock for years” then you should be aware of the events prior to and following 9-24-12. You should know that this stock was over $5.00 and climbing.
“If Bavi is really that good, big pharma would have partnered up long ago.”
Why do you think that “big pharma would have partnered up long ago.”? I would not have thought so for Bavituximab. If the theory of Bavituximab’s broad-spectrum capability is proven correct what price would PPHM have gotten with very little proof years ago?
“The latest management fiasco at Peregrine speaks volumes about the incompetant BOD.”
If you are referring to the PII second line NSCLC trial as the latest management fiasco you will need to explain how some entity who’s operation was blinded to management is somehow responsible for that operation. Take all the time you need on this one…
“Now we may be faced with another ATM...?”
Maybe…But my gut feeling is that IF they need additional money beyond the $30M they have in the bank it won’t be for general operating expenses.
“Will management ever offer a real explanation of the events leading up to the failed trial...remember, management told us we would have detailed information "in weeks, not months". Months later, we still have no news.”
The words “real explanation” implies that the explanation provided was unreal or false or inaccurate. Please correct me if I’m wrong but I will assume you meant incomplete to date, which is true. However they did provide an update during the CC and stated that they intend to present the results to FDA when the review is completed. I agree that waiting is always frustrating.
“Will this failed trial just fade off into the sunset as did the breast cancer, HIV and other "promising" uses for Bavi?”
You will need to explain this in far more detail…It’s way to far off the charts for me to assume anything.
“Peregrine is now attempting to partner the Cotara program, which has been around for many, many years. A phase three Cotara program with 300 patients will take years to complete, if ever.”
YEP…AND?
“I stand by my statement the we need real results, real soon or this company will continue to dilute its shares and continue to screw it's shareholders!”
You actually wrote:
“Hope is a four letter word....we need real, verifiable results from this company and soon. If Bavi is as "good" as we "hope" it is, then why is the stock at $1.20 ?”
You, I and every long on this board wants to see results quickly and for the same obvious reasons. Most of us feel that the company will be able to report on the results of the pancreatic and first line NSCLC trial in the next few months and hopefully will be able to unravel the data from the second line NSCLC trial as well. And then there’s the IST’s and imaging…
Regards
Golfho
I think that you are trying to play the devil’s advocate. I think that you are trying to brace yourself for another major disappointment.
Quote:
“This, IMO, is another reason that no news might not necessarily mean good news. “
Fact:
The second line NSCLC trial was the only double blinded trial of the three important PII trials. It was the only one, where PPHM did NOT see the data before it was unblinded.
Fact:
The other two important trials are open label. PPHM sees the data on their regularly scheduled cycle.
Opinion:
At that time they will have checked; and after this debacle, double checked dosing. Note: coding would not be necessary because the trials are not blinded. Also note: Everyone in management, short of an absolute idiot would have said shortly after Sept. 24th “ For GOD sake…Check the other two trials.
Opinion:
We have not reached MOS in the two remaining PII trials yet. Every day without news is another day added to the MOS numbers.
Opinion:
Take a deep breath…Drink a glass or two of cheer…Hug your family and friends…
Too you and everyone on this incredible board…
I wish a very happy and healthy holiday.
Regards
Golfho
Hi Wildhorses...
I've always considered you one of the clear thinkers on this board. And what you are suggesting is in fact what I started to do several years ago as part of my risk reward assessment. The risk part was always the easiest. The rewards part had to many paths to follow; required to many assumption. I've posted some of my assessments on this board over the years. I always stopped at the "WOW" or "HOLY_SHIT" portion of the program...!!!
As I stated is previous posts. Since my retirement I move at glacial speed...except when I play golf.
Perhaps some of my earlier assessment that I posted could be updated as a start. I'll try to complete a new years re-evaluation...probably won't be done until mid January or February...That's quick for me...!!!
Happy Holidays to all.
Regards
Golfho
Boy that Adam guy has great timing...No...?
And a sense of humor...
"Witnesses on the scene said die-hard Peregrine supporters from the iHub message board were directing the zombies to vote for anyone but Peregrine CEO King."
Enjoying the rally today
Regards
Golfho
On Monday I ripped my plantar fascia…
So yesterday I had nothing better to do, but sit at my computer most of the day…When I read yesterday’s article by our friend AF I decided to respond…By the way this is why, when I was a small child, before my mother took me to the zoo she reminded me; “Don’t annoy the animals”
My e-mail to AF:
SIR…
Let’s get a few fact straight. Unless, of course, you are yet another person that won’t let Fact-Check get in the way of what you are saying.
Please see below your article on Steven King and Peregrine Pharmaceuticals with my comments inserted
Steven King, Peregrine Pharmaceuticals:
Clinical trial failure happens all the time in biotech and is not enough to land a chief executive a "worst" nomination. Peregrine's King, however, isn't just an innocent victim of bad luck. Under his leadership and in public, Peregrine shamelessly hyped and promoted bavituximab in the months leading up to the September lung cancer data results, promising investors that "exceptional" data was sparking interest from potential partners
(“shamelessly hyped and promoted” At that time “months leading up to the September lung cancer data results” that would be May, June, July and August, Peregrine issued these PR’s: This one announcing preliminary results for the second line NSCLC trial in MAY
http://files.shareholder.com/downloads/PPHM/1090687297x0x570829/feaa148d-2e6d-4034-9e5c-c68f461a79b0/PPHM_News_2012_5_21_Peregrine_News_Releases.pdf
This one announcing the fourth quarter results in JULY
http://files.shareholder.com/downloads/PPHM/1090687297x0x583254/8edb5723-e8fe-4e62-ab9a-ad23763cf08b/PPHM_News_2012_7_16_Peregrine_News_Releases.pdf
THAT’S IT FOR THE MONTHS BEFORE SEPTEMBER…!!!
So your statement “Under his leadership and in public, Peregrine shamelessly hyped and promoted bavituximab in the months leading up to the September lung cancer data results, promising investors that "exceptional" data was sparking interest from potential partners.” Is an absolute falsehood, A COMPLETE MIS-STATEMENT OF THE FACTS.
On 9-7-12 we get this one announcing the “Late breaking news to be presented at the 2012 Chicago Multidisciplinary Symposium in Thoracic Oncology”
http://files.shareholder.com/downloads/PPHM/1090687297x0x595568/19770443-664d-4377-9e39-ae2256494aed/PPHM_News_2012_9_4_Peregrine_News_Releases.pdf
And 3 days later we get this one announcing the first quarter results on 9-10-12
http://files.shareholder.com/downloads/PPHM/1090687297x0x598703/107753ee-5410-4b1d-9be8-c79fd357e1a5/PPHM_News_2012_9_10_Peregrine_News_Releases.pdf
[color=red]"This is the first time that Mr. King stated “exceptional” and Robert Garnick added “the data we announced last week [9-7-12/Gerber/Chicago] has far exceeded our expectations, and I hope that you're as excited as I am with bavituximab's potential.” AND from Robert Garnick “Having personally been involved in the evaluation of over 30 Phase II trials over my career, none of which ever achieved statistical significance, including many of today's blockbuster biotech products, I am personally extremely pleased with the quality of this data and the clarity with respect to advancing bavituximab in Phase III trials which it provides.”[/color]
The data that was provided by the third party CRO WAS in fact exceptional. “The interim data showed a statistically significant improvement in OS (HR 0.524, P-Val .0154) and a doubling of MOS (12.1/13.1mos. vs. 5.6mos.) in the Bavi-containing arms vs. Doce'ctl-arm."
“Privately, however, King directed the company to sell millions of dollars in company stock through opaque, backdoor and highly dilutive financing deals.”
THE ATM WAS WELL KNOWN TO ALL INVESTORS…IT WAS NO SECRET. IT WAS INITIATED YEARS AGO, AND HAS BEEN USED SINCE AT LEAST 2009.
YOUR STATEMENT IS PATENTLY FALSE AND MISLEADING, AS NO SHARES WERE SOLD IN JUNE, JULY, AUGUST AND SEPTEMBER.
FROM THE 10K & 10Q (date & outstanding shares)
7-13-12 104,174,056
7-31-12 104,178,431
8-16-12 104,191,176
9-7-12 104,191,176
That’s two serious misstatements of facts.
I’ll go on...
“And then, it all blew up. On Sept. 24, Peregrine threw out the bavituximab lung cancer results due to "major discrepancies" in the conduct of the study.”
That is another serious distortion of the facts. This is what they said here in their PR:
http://files.shareholder.com/downloads/PPHM/1090687297x0x601695/8e5af82d-1895-4d35-8a63-872deefe9196/PPHM_News_2012_9_24_Peregrine_News_Releases.pdf
“Peregrine Pharmaceuticals Announces That It Has Discovered Major Discrepancies in Treatment Group Coding by an Independent Third-Party Vendor Responsible for Distribution of Blinded Investigational Product Used in Its Bavituximab Phase II Second-Line Non-Small Cell Lung Cancer Trial”
NOBODY…AT THIS TIME, CAN STATE CLEARLY WHAT THE IMPACT OR IMPLICATIONS ARE. YOUR STATEMENT “PEREGRINE THREW OUT THE RESULTS” IS GROSSLY MISLEADING.
The “Major Discrepancies in Treatment Group Coding by an Independent Third-Party Vendor” could very well be a mix-up between the 1mg/kg group and the 3mg/kg group only. Nobody knows for sure. Not you, not me…NO-ONE.
Now for the most offensive, incorrect and unproven statement in your assessment.
“The doubling of survival attributed to bavituximab turned out to be a hoax.”
A HOAX…!!!
From dictionary.com:
1. noun
Something intended to deceive or defraud
That word implies that YOU think that this was an act of fraud. The reported results were purposely manipulated by management to produce “exceptional” & “inexplicable” results. Slander?
Let’s go through a little test of logic.
Case #1
You split a group of very sick patient 50-50 one half gets the SOC and placebo and the other half gets SOC and drug that is no more effective than the placebo.
Hopefully both you and I and the VAST majority of people would conclude that you would get very similar results from each group.
Case #2
You have the same split of very sick patients. One group get the same SOC & placebo, the other gets X. You suspect that X is a very active treatment. IF the patients that got X lived twice a long as the patients on SOC & placebo. You most likely would conclude that X was very active and exceptional.
Case #3
You have the same scenario as in case#2; however the people administering the two arms of the trial mix up the treatments. Some patients that were supposed to get SOC and placebo got the SOC and X and some of the patients that were supposed to get SOC and X got SOC and Placebo.
I hope that you can see the obvious answer to this…
The greater the amount of patients that received the wrong treatment; the smaller the divergence in results would get.
Bavituximab’s previous signal seeking Phase II clinical trial MOS data to date in breast cancer and NSCLC; coming soon first line NSCLC with a different SOC, pancreatic cancer, liver cancer perhaps clarification on the second line NSCLC…
Perhaps you should close your short position soon.
One last note…
I think that there are reasons to knock Steven King but hyperbole is not one of them. He’s more a scientist that a CEO; scientists by there very nature are a conservative lot, not inclined to spew fluffy crap. For sure he’s not a dynamic speaker, he’s not a storyteller but he is a scientist. I know you know this; you were at the last C.C.
His response:
“sorry for your losses. you must feel like a real idiot investing in PPHM. my condolences.
Adam
Adam Feuerstein
Sr. Columnist
TheStreet”
My response:
“Brilliant response...
Well thought out...
Covered all the points I made...
I am in awe...
His response:
‘yeah, i stopped reading your email after the second sentence. i don't have time to waste on idiots.
Best - Adam
Adam Feuerstein
Sr. Columnist
TheStreet”
I couldn’t help my self…I responded:
“Did I mention charming as well...???”
I need to get out of the house…!!!
Regards,
Golfho
A general question on PPHM options…
I copied a portion of the options chain for PPHM April calls, below:
Strike Price Bid Ask Vol
2.5 .20 .25 ~24K
4 .10 .20 379
5 .5 .20 ~21K
It seems that the best choices would be the $4.00 strike price for the Ask price of $.20 and the $2.50 strike price for the difference of $.05 in the Ask and a $1.50 in strike price.
Input…???
Regards
golfho
PPHM and the human psyche…
This has been an incredible month. We were flying high and going higher. Then out of the clear blue sky came a thunderbolt…That thunderbolt knocked us down to the ground.
What to make of this nightmare…
“Investors cannot rely on data presented” The gold standard PII test results had coding errors…
SMACK DOWN…
Within nano-second came criticisms of management, questioning everything and anything they did or didn’t do.
Many new arrivals questioned the science.
NOBODY…AND I MEAN…NOBODY, INCLUDING MANAGEMENT KNEW THE EXTENT OF THE PROBLEM.
They found errors in coding during a review. A review that was performed as a routine review prior to the EOPR with the FDA.
IN MY HUMBLE OPINION…
These four words or their equivalent should always PRECEDE an opinion not FOLLOW it.
Please take note LC2020 et. al.
In my humble opinion, I think that the debate over the “Too good to be true” results for Bavituximab in the second line NSCLC will boil down to this:
1- How does it compare to all other clinical trials for Bavituximab?
I think that it compares very well and is in line with both breast and NSCLC signal seeking PII trials.
2- What is the nature of “coding errors” and how will that impact the company going forward?
This is where subjective opinion, must be applied; and where all hell breaks loose. Today’s PR did little to clarify definitively, whether the placebo arm was part of the coding errors or not. However, I think that most people can reasonably conclude that a doubling of the historical survival time was not caused by a saline solution. What appears to me, to be impacted, are the results of the two Bavituximab arms. I’m surprised that no one has asked the question…Why two separate dosing arms? The three previous signal seeking trials were dosed at 3mg/kg. The first line NSCLC trial dosing was 3mg/kg. Every trial with one exception (Liver @ .3, 1 & 3 mg/kg) was or is at 3mg/kg. I speculate that management wanted to understand better the effect of Bavituximab at different dosing levels vs. any adverse effects. That information may not be recoverable.
3- So, what’s the impact?
I doubt that the errors will ultimately render the results totally useless. I do feel that the data errors may not give management the information that they were looking for with reference to the dosing for the PII trial. Will the FDA not approve a PIII trial? With a combined MOS doubling the SOC I doubt it. However, management may now be stuck with making a dosing decision without the data that this trial should have produced.
What are the goals?
1- Establish the safety profile for Bavituximab
2- Establish the efficacy of Bavituximab
3- Demonstrate that Bavituximab IS broad-spectrum
IN MY HUMBLE OPINION…I think we are close…Very close.
Back to the human psyche…
There were times when I played Texan Holdem that I would observe someone with an apparent winning hand that ended up losing on the river. It’s called a bad beat. It happens in life, all the time. I’ve seen players blame the dealer for bad beats. For them it couldn’t be just bad luck or their failure to properly assess the potential outcomes. I understand anger and frustration but blaming management for problems beyond their control is just like blaming the dealer for the bad beat…All IMHO
See the subtle difference?
The above was just a statement of my opinion, not a start of any argument. Everyone is entitled to their opinion. My primary reason for reading this board is to learn as much as I can about PPHM and Bavituximab. Some of the poster on this board IMHO are approaching genius status. Some…Not to much.
My only purpose in posting was to share my risk/reward assessment. I only post when there is a significant change to my assessment.
IMHO…There is no change.
Regards
Golfho
Science guys...
Any comments on this latest "censored patients" statement from Adam?
Does he have a point?
Regards
Golfho