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It seems...
We have the same nightmare...
Regards
golfho
NO TRUER WORDS HAVE BEEN SPOKEN...
Hi CP;
You wrote.
FOCUS ON 2016…
What did management tell us at the last CC…???
FOCUS ON 2016…
FOCUS ON 2016…
FOCUS ON 2016…
FOCUS ON 2016…
What should we be doing…????
FOCUS ON 2016…
FOCUS ON 2016…
FOCUS ON 2016…
Are you frustrated over the pace of development…???
Are you angered over the sabotage of the PII…???
Are you confounded over the lack of clarification WRT partner/collaboration …???
Is this the right investment for you…???
Here are my assessments of what has occurred to date this past (2014) year and my expectations going forward.
And more importantly…How I plan to handle them.
I expected an announcement on a partnership/collaboration in 2014. That did not occur and I have little expectation that it will occur in the next 3 or 4 weeks. Management has downplayed a partnership in the most recent CC.
What do we know for sure…???
PPHM has been involved in dozens of collaborations over the past 12 months. We have heard of only ONE additional.
We can speculate on some of the others by viewing slide #8 from the last Quarterly CC and reading Dia’s numerous “Catalyst-Potential News List” posts.
PS Receptors:
AxL: Genetech
TIM-1: Celldex
TIM-21: Hokkaido Univ.
Immunosuppressive Cytokines/Enzymes:
TGF-b: Acceleron, Sanofi, Isarna
IL-10: BMS, Takeda
IL-21: BMS, Centocor
IDO: NewLink, Incyte
Downstream Immune Checkpoints:
PD-1: BMS, Merck, AstroZeneca
PD-L1: Merck, BMS, AstroZenica
CTLA-4: BMS, AstroZenica
Site openings now exceed 150 sites for the SUNRISE trial and perhaps we might hear something like “Enrollment is on schedule” I’m not counting on that.
I created a spreadsheet called “SUNRISE Enrollment Projections” If anyone would like a copy I can PM it to you now that I’m a paying member. The results to date are:
1 - Current sites = 152
2 – I make three enrollment per site assumptions: One is; first patient enrolled within 2 month and an additional patient enrolled every 4 months there after per site. The second assumes 1 patient per site every 4 months. The third assumes 1 patient per site every 3 months
NOTE: In both previous PII trials for NSCLC we averaged MORE than 6 months per patient per site. At that pace we would not complete enrollment until August 2016
Implied results:
1 - Enrollment will be complete in the time frame of July to December 2015 based on the 3 assumption above and August 2016 based on historical data.
2 - If the first look-in is based on ~150 events it will occur around August-November 2015
3 - If the first look-in is based on ~200 events it will occur around September – December 2015
AND…
SO WHAT…???
The first thing I will do is lower my expectations going forward…And listen very closely to what management will be saying.
Let me state clearly that I do not, in any way, have lower expectations with respect to the ultimate ASTRONOMICAL value of the anti-PS platform. IT’S THE WHEN.
AND NOBODY KNOWS WHEN…NOT EVEN MANAGEMENT.
So…
What do I know?
1 – Dissemination of information to the scientific community on PS targeting and validation of the science continues. During calendar year 2015 we will hear more about the liver cancer trial and we will read the published data on the breast cancer IST.
2 – Clinicaltrials.com most recent updates still include the following:
A: Estimated Primary Completion Date: April 2015 for the PGN650 Imaging trial (Yep…3 years to recruit 12 patients)
B: Estimated Primary Completion Date: August 2015 for the Bavituximab plus radiation trial
C: Estimated Primary Completion Date: March 2016 for the combo Bavituximab/Yervoy. Because this is an open label test we might get an interim readout in 2015
So…
What am I speculating?
1 – You don’t have to be a rocket scientist to assume that partnering discussions are not following management’s original schedule. So what are some possible reasons?
A: A regional deal with one or more BP’s is a non-started for any BP.
B: The revenue split is still not satisfactory for both parties.
C: There are still questions on BP’s mind concerning the market potential of Bavituximab.
2 – What does the most recent shelf registration imply?
A: PPHM will fund additional late stage clinical trials in liver or breast or both.
B: PPHM will initiate clinical trials with some of the downstream immuno’s without a partner.
C: The shelf shares will be used to bring on a partner and bring in a significant amount of cash.
So…
What are my predictions?
I MAKE NO PREDICTIONS…
It’s silly to try. There are too many variables. The best I can do is speculate about the possibilities. Most of which are stated above.
What will I do…???
NOTHING RIGHT NOW.
What have I done…???
I am now a paying member of I-hub.
I have put several additional poster on ignore.
I have been all in and remain so.
The one thing that gives me occasional nightmares is the possibility of additional sabotage.
Now back too “What will I do?”
My wife and I spend the winters in Florida. I generally leave NY in mid October. This coming October I will change my schedule and will attend the ASM. For better or worst I suspect this one will be quite different.
Good luck to all.
Regards
golfho
HAPPY 2015 TO ALL...EOM
WELL DONE SIR...EOM
regards
golfho
One quick note...
WRT Fauci...
Look up:
"NOT INVENTED HERE" syndrome...
I'm grabbing my clubs as I write...I have my priorities...!!!
Krak...
I Love you too...In a manly sort of way...!!!
Regards
golfho
Time for a group hug...???
This is my first attempt to attach an excel spreadsheet to my post
It represents my SUNRISE enrollment estimator. Assumption are:
1 - Current sites = 144
2 - Enrollment per site is first patient enrolled within 2 month and an additional patient enrolled every 4 months there after
Implied results:
1 - Enrollment will be complete in the time frame of October to December 2015
2 - If the first look-in is based on ~120 events it will occur around June-July 2015
3 - If the first look-in is based on ~200 events it will occur around August-September 2015
Regards
golfho
I thank both of you for your response and recollections...
Of all the things I miss...
I miss my mind the most...
Regards
golfho
Hi cheynew;
It's my recollection that this is the first time that the ASM will be available via webcast.
I remember writing to IR about this several years ago and remember being told that it was not company policy to webcast the ASM.
Is my recollection correct or am I having a 60's kind of mind bending, memory distorting flashback...???
If this is the first webcast; it implies to me that they want to reach-out to as many shareholders as possible.
Regards
golfho
ROUND TWO...MAYBE MORE ACCEPTABLE...
THERE IS ONLY ONE THING THAT KEEPS ME AWAKE AT NIGHT.
For those of you who have not read my early posts; the subject matter of my posts for the first few years consisted of calculating the Risk of this investment in PPHM vs. the Reward. In my risk assessment prior to the September 2012 disaster I considered the Risk to be on par with the historical statistical success rate for clinical trials going from a successful PII trial to a PIII trial (About 1 out of 3-4).
The one thing that I have not been able to assess was out and out sabotage by a BP or Hedge Fund. How does one factor that in? To what level will these (XXX) sink…After 50 years (STUFF HAPPENED...) BP’s are paying fines in the billions and now consider these fines just the cost of doing business and few…very few…go to jail.
As someone else already posted (Sorry I don’t remember) I’ll para-phrase…The sabotage is both bad & good. in that it was bad because of the delay to market & added cost but it was good in the sense that Bavituximab is a clear paradigm shifting threat to many PB’s…So much so that it is worthy of sabotage. So in my opinion the risk has risen significantly; but, I can’t quantify it.
For me it is the same as being in a high stakes no limit poker game and after you just pushed in all of your chips and declared “All in” you discover that the game is rigged. Huh…??? Excuse me…!!! Say what…???
No one knows, too what level these scum_bags will go. What was their purpose? Was it to slow down development of Bavituximab until they could catch up or bypass it? Hobble PPHM and then scoop it up as CP says…For breadcrumbs? Is there still more to come? Will they try to somehow subvert the SunRise trial? GOOD GRIEF…I have to stop thinking about this. But unlike a poker game, I can take my money off the table at any time. Everyone of you can. BUT I WON’T…
WHY…???
Because I am convinced beyond a doubt that Bavituximab works.
What if the nefarious forces succeed in destroying most of the current shareholders value?
Currently I am shifting between sitting in my darken bedroom and sucking my thumb and thinking very very dark thoughts.
At the end of the day…If things work out well, I’ll enjoy the remainder of my life. If the nefarious forces win…I may go postal.
NOW LOOKING FORWARD…
MY ASSESSMENT FOR THE NEXT 12 MONTHS:
Before I start I would like to thank Dia76ca again for starting this list of potentials. I have modified and grouped things in what I think might be the chronological order.
1 - SUNRISE TRIAL:
2 – IST’s, FUTURE TRIALS & COLLABORATIONS:
3 - FINANCE:
4 - LAWSUITS:
1 - SUNRISE TRIAL:
To my amazement the long hockey stick trial site opening has occurred. We now have a total of 143 trial site opened. FWIW 13 of those 143 sites are sites that were used in the PII trial. I have no idea when the first look-in will occur but, my estimate is aligned with Jbain, geo & several others. That is, we may hear something around the June to September 2015 time frame on the first look-in. Baring any shenanigans I believe that the results of the first look-in will produce results similar to the PII trial and that will prompt an early marketing approval from the FDA by the end of 2015 or the beginning of 2016.
2 – IST’s, FUTURE TRIALS & COLLABORATIONS:
Phase I/II Trial: IST of bavituximab in combination with sorafenib in patients with liver cancer
Like all of our IST’s there is a very long gestation period before the birth of data. We may hear about new tests that are surrogate indicators of active immune response in November. What about the trial data…? What’s with Dr. Yopp & Bayer…Inquiring mind want to know. More on that later…
Phase Ib Study: IST of bavituximab in combination with carboplatin and pemetrexed in patients with previously untreated Stage IV NSCLC
In the Overview section of PPHM’s Clinical Trials it states:
“Enrollment Complete” The clinicaltrials.gov site last updated in February 2014 states “This study is currently recruiting participants”
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
The above from clinicaltrials.gov tells the story…
Phase I Study: IST of bavituximab in combination with paclitaxel in patients with HER2-negative metastatic breast cancer
We are now waiting for the published paper from Dr. Alison Stopeck could be published by December...Hopefully.
Phase I Study: IST of bavituximab in combination with capecitabine and radiation therapy in patients with advanced rectal cancer
Still recruiting…
As of the May 2014 update:
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: August 2015
A Two-arm, Single Center Phase 1b Trial of Bavituximab Plus Ipilimumab in Advanced Melanoma Patients
This trial has been recruiting for 5 months now. They hope to complete the trial by 3/2016. Of importance here is the fact that Ipilimumab (Yervoy) is BMS’s already approved anti-CTLA-4. More on that later.
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Open-label, Single Arm, Tumor Imaging and Dosimetry Study of I-124 PGN650 in Advanced Solid Tumors
As of the last update in July this trial is still recruiting and has an estimated primary completion date of April 2015.
PRE-CLINICAL:
In August PPHM reported “Results show that the combination of a PS-targeting antibody equivalent to bavituximab administered with an anti-PD-1 antibody displayed statistically significant tumor growth suppression while also demonstrating a significant increase in tumor-fighting T-cells into the tumor microenvironment compared to anti-PD-1 antibody treatment alone in an immune competent animal model of breast cancer.”
AND:
“This presentation includes new data showing that animals treated with the PS-targeting antibody ch1N11, the preclinical equivalent to bavituximab, in combination with anti-PD-1 in an EMT-6 mouse breast tumor model, significantly delayed the treatments group median tumor growth compared to anti-PD-1 alone. Specifically, following once weekly treatments of ch1N11 plus anti-PD-1, tumor growth was inhibited by 78.7% (p= 0.0048 on day 23) compared anti-PD-1 alone. In addition, 50% of the tumors treated with the combination either regressed or did not progress compared to 0% for anti-PD-1 alone. Also, the once weekly combination treatment with ch1N11 and anti-PD-1 led to a 78% and 81% increase in intratumoral CD4+ and CD8+ T cells, two key indicators that show that tumor fighting immune cells are present in the local tumor environment, compared to the single agent anti-PD-1.”
What is interesting about this pre-clinical report is that PPHM DID NOT reveal whose anti-PD-1 it was. Roche…??? Merck…??? BMS…??? In my view for a reason. They most likely tested all of the PD-1 candidates. That implies the following. PPHM is in collaboration with:
(From cjgaddy’s super fine intro)
Examples of anti-PD-1 drugs in development: (PD1=”Programmed Cell Death Protein 1”)
1. Merck’s pembrolizumab (aka MK-3475, formerly=labrolizumab)
2. BMS’s nivolumab (aka BMS-936558)
3. Curetech’s pidilizumab (aka CT-011) Teva/partner term. 1-2013
4. AZ/MedImmune’s AMP-514 (aka MEDI0680)
5. GSK’s AMP-224 (collab. With Amplimmune)
No report yet on the following
Examples of anti-PD-L1 drugs in development: (PD-L1=”PD1 ligand”)
1. BMS’s BMS-936559
2. Roche/DNA’s MPDL3280A (aka RG7446)
3. AZ/Medimmune’s MEDI-4736
4. EMD/Serono’s MSB0010718C
And then from the IASCL poster we see a list of some downstream immunostimulatory treatments such as: Anti-TGF-b, Anti- IL-10, GM-CSF, IFN-a, IL-2 & Vaccines
We can stop at this point. Knowing that we are in collaboration with dozens of candidates implies that we are in collaboration with MANY of the major BP’s and probably with several second tier pharmaceuticals as well.
Now back to…”More on this later.”
We are in clinical trials with the following:
Bayer: Sorafenib + Bavituximab = Liver
Sanofi-Aventis: Docetaxel + Bavituximab = NSCLC
Bristol-Myers-Squibb: Paclitaxel + Bavituximab = with HER2-negative metastatic breast cancer
Bristol-Myers-Squibb & Eli Lilly: Carboplatin & Pemetrexed + Bavituximab = with Stage 4 NSCLC
And we have dozens of collaborations in pre-clinical. I was stuck on the word “collaborations” a while back. Partnerships, collaborations why bring in another term…? We all pondered this.
This is what I think is going on. We are collaborating with as many of the downstream immuno’s that we can. (Note: We cannot use anyone’s produce; that is not FDA approved without the sponsors’ approval.). I think that we are splitting the cost of these low cost pre-clinical trials. When all of the data is in we will select the most promising candidates and K & L Gates will negotiate as best they can regional partnerships. We don’t need a partner for the PIII NSCLC trial it will be paid for by us. I can’t see beyond this for now.
3 - FINANCE:
I think that management will try to maintain a cash reserve of ~$60M to $80M to fully finance the SUNRISE trial and continue to share the cost of the pre-clinical trials.
4 - LAWSUITS:
The frivolous CA lawsuit will go away some time. It is only an annoyance.
It appears that the CSM lawsuit will go on for some time to come.
OT observation:
Many of the longs are very frustrated, me included. But to lash out at management is miss-directed. They didn’t sabotage the trial and they had an agreement in principal for a partnership. Under the circumstances IMHO they are doing a commendable job. This was not an invitation to debate the subject. I’m just voicing my opinion and I respect everyone’s right to have a different one.
Regards
golfho
I intended to post an assessment a while back...
But personal and wife health issues surfaced.
I plan on posting my views soon...
FWIW...
They are positive...
P.S.
eric...I'll get back to you on your "dilution" assessment as well.
Regards
golfho
I have a question for the board...
What would be the up side or down side of selling some PPHM and purchasing PPHMP with the proceeds...?
Thanks in advance for any opinions. Pro or Con...
Regards
golfho
You're correct...My bad...EOM
FWIW...
I just reviewed the clinical sites and noted that 2 of the 3 sites in Louisiana were removed. So we now have 98 in total.
Grrrrr....
HAPPY 4TH OF JULY TO ALL
Regards
golfho
Response to my Expectations post 4-8-14
Irishpark:
You’re right…I didn’t include Avid’s contribution to the mix. Currently that amounts to ~$20M at ~40% margin that amounts to ~$8M annually. It doesn’t cover the nut…But not to shabby…
Hypi:
It may help to click on the link in my post…Ommmmmmm…
The Other Guy:
Thanks for the info. I no longer read every post. Sorry I missed your post and any following discussions. My priorities have changed over the years. I have always lived life to the fullest, but now that I’m retired and 66 years old I have a sense of urgency to enjoy life as if today is my last day.
Skweze:
I agree with all of the points that you made…In particular…this:
“I suspect that some sort of agreement in principle is on the table right now, subject to conditions, and it's simply a matter of time before an announcement.”
Thanks to all others...
In the interim…
I hear my golf clubs calling me…
Regards
golfho
2014 MILESTONES & EXPECTATIONS-APRIL
I did not post this for March because I wanted to see what March Madness would produce.
I have updated the format to reflect the current reality.
1 - SUNRISE TRIAL:
2 - FINANCE:
3 - IST’s:
4 - UPCOMING EVENTS:
5 - FUTURE TRIALS:
6 - LAWSUITS:
7 - COTARA PARTNRESHIP:
8 - DR. BREKKEN et. al. and KOL ANNOUNCEMENTS (PUBLICATIONS, EDITORIALS, PRESENTATIONS):
9 - NEW/UPDATED ANALYST COVERAGE:
10 - THE RETURN OF ANTI-VIRAL:
1 - SUNRISE TRIAL:
Since February’s update there were only 3 additional sites added. We now have 15 US sites. In the prior PII trial there were 24 US sites. Of the current 15 site, only 4 are the same as the PII trial, the other 11 are new sites. Maybe the new sites are more prestigious…
There’s no way that the trial will achieve its goal of completing enrollment by the end of 2015 at this leisurely pace. We are all expecting the start of trials in Europe and Asia.
I am still hopeful that the delay is associated with partnering negotiations. I, just like everyone else on the board am patiently awaiting this news. OK…Some are waiting patiently…
Chanting Om…helps…!!!
Actually...
As several posters noted already the abstracts will be posted on ASCO's website on the 14th of May. However...The authors of the abstracts should have been notified by now...
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.”
UTSW should know by now...Maybe PPHM will know as well.
Regards
golfho
Thanks Dan;
I've tried that before. the problem that I'm having is that the spreadsheet is larger than one screen worth of depth. The Excel spread sheet in ~210 rows deep but you can only display ~30 rows at a time. When I scroll down in Excel I lose the screen shot.
Help...
Regards
golfho
How do I include an Excel spreadsheet into a post and not loose the format?
Regards
golfho
Thank you...
Regards
golfho
HYPI…HYPI…HYPI…
I don’t usually respond to post of this nature because I view them as written by…
1 – A disgruntled investor
2 – Someone with an agenda
I know that you are new to this board and my sense is you are unhappy with the current share price of PPHM. I have no intentions of pretending that I am a spokesman for all of long time longs. But, I’m sure that some will agree with my response…
"I know all the longs still feel good and don't really care about the price.”
That statement is condescending to the max…
NO ONE FEELS GOOD WHEN THEIR INVESTMENT GOES DOWN…!!!
NO ONE FEELS GOOD WHEN THEIR INVESTMENT GOES DOWN…!!!
NO ONE FEELS GOOD WHEN THEIR INVESTMENT GOES DOWN…!!!
No one.
“Price doesn't matter, either does dilution”
ALL LONG TIME LONGS HAVE SEEN THIS HAPPEN BEFORE…
Some of us have seen this occur several times before.
Every time this happens it’s a gut check…EVERY TIME.
And investors must make a decision. Traders will trade, Momentum traders will trade, TA traders will trade, value investors will look into
Investments that appear undervalued in their sector and Biotech investors take very risky bets on poorly understood technology in the hopes of making a killing. Let’s face it 9 out of 10 times; if you bet against a Biotech you would win.
Price & Dilution always matter…But it only matters when you buy or sell.
“or management wanting their options at the lowest price possible.”
For the love of GOD…EVERY TIME THAT THE PRICE GOES DOWN SOMEONE COMES AROUND AND SAYS THAT.
On what evidence do you base that on? Ask jakedogman1 for help…He’s been saying that for years…!!! NOTE: Most of their options have expired out of the money…So I guess they’re not good at that either…!!!
“Its all good as we have break through technology that will safe the world. Broke the 50 day moving average, but its all good and a once in a lifetime buying opportunity. All good.”
NO…
It’s not all good. Shit_happens. And every time it happens…YOU…must evaluate the circumstances and make up YOUR mine.
We longs are NOT all idiots, and we are all different people, have different perspectives and react differently to different circumstances.
Please don’t take this rant as an invitation to a fight…It’s not
I just don’t like to hear that someone thinks that I’m a BLIND FOOL, totally lacking in common sense.
Regards
golfho
Yes, they are the two sites in Texas
And (Using the zip code)from the looks of it, they are the same as the ones from the PII trial
UTSW & Mary Crowley Cancer Research Centers
Regards
golfho
Perhaps he's just as concerned as I am...
I replied to your post as well as several others who requested that you not send that letter to the SEC. The idea of waiting until events play out, that I suggested, apparently did not cause you to pause and reflect. But when I'm riding in the same bus as you are...And you're having an argument with the bus driver...And you decide to "Take action" by shooting the bus driver; it directly affects my life...And everyone else on that bus.
Pause and Reflect...
Pause and Reflect...
Pause and Reflect...
As for your issues with CP...At this point...Both of you should put the other on ignore. There's no reason for you two bright people to keep poking at each other. Please take the high road.
Regards
golfho
Hmmmmmm....
Maybe.....
Please check with Mr. E...
Good Night.
Regards
golfho
From your lips to God's ears...
"The anti-PS platform and all of Peregrine will be more than any one Big Pharma could probably handle to buy completely out so a 50-50 partnership is hopefully whats in the works."
And in fact...
Those are my thoughts...
Exactly...
Regards
golfho
EYEBUYSTOX…
I beg you to think some more before you send out any letters. This cannot help ANY shareholder one bit. It will depress OUR share price for a long time; too no ones benefit. I doubt seriously that anyone in management would initiate something like this. I wouldn’t doubt for a minute that someone from a BP or MLV suggested something like that. It would make more sense as they would stand to gain from that action. But requesting an investigation now…And worst yet having an investigation started now can only delay or break any pending deal.
I share your frustration and anger with what seems like endless delays. But this action appears to me to be counterproductive and will result in a self-inflicted wound. You can file it later if nothing comes to fruition by the end of this year.
“I'm just so sick of the games after Fargo and the fact that so many patients were delayed treatment.”
Unfortunately it’s not just Fargo…It’s the corporate world as a whole. As I stated before…Wall St et. al. is like a giant cesspool, worse than the open cesspool in the movie Slumdog Millionaire. I remind you of Goldman Sacks, B of A, SAC, Enron and the list can go on forever. In my view…They are much bigger and smellier turds.
I would suggest that you leave the computer for a while. Have a drink if you drink. Take a long slow walk. Think about some of the good things in your life. Perhaps when you return you’ll be less angry. More calm. Perhaps you’ll rethink your decision about sending those letters…For now anyways.
Rest assured…When you return the cesspool and all for the turds will still be there.
regards
golfho
Wookie & Funworker1…Thank you for your kind words.
Dia…We seem to be of like mine. And thank you for your affirmation. I still regard your list of expectations…as a guide. I’ve borrowed it and modified it…But you first put it in perspective.
Keep Trying…
“In 6-8 years PS targeting (Bavi plus Betabodies?) may be applied to 25 cancer indications and 15 virus applications along with companion imaging. It may be a Standard of Care with radiation, chemotherapy and many immunotherapy combinations. It may be an important part of CURING many cancers and viral diseases.
These are the early days for PPHM. These are the early days for PS targeting technology. It is exciting to be part of this scientific revolution!”
I could not have said it better…
Now to the question of…”I find your risk weighted one chance out of six for success analysis worthy of a refinement.”
In fact I put forth a range of 30% to 15%. That is between one in three and one in seven.
One of the most profound statements you made was…
“Per risk management techniques, if the individual risk profiles are independent of each other, meaning that one external event doesn't effect them all, the company that has multiple business ventures underway exhibits a much lower risk for not achieving at least some of its targets than a company dependent on a single venture for success.”
Let me state this in no uncertain terms…I AGREE 100%...
I just felt that putting forth a more optimistic assessment would lead to a more cynical response.
I actually stated in several previous posts that I no longer considered PPHM to be a “High” risk investment…Your independent evaluation strengths that assumption.
“Analogies are never perfect, but I observe that the PPHM technology for anti-PS treatments has multiple applications and multiple products diversified sufficiently amongst different trials so that the risk of PPHM failure is much diminished from the sort of single trial outcome characterizations to which PPHM was vulnerable to a few years ago”
That statement almost made me replay the you tube presentation of Handel’s “Hallelujah Chorus”
You stated:
“The key value changer that is needed to resolve fundamental PPHM company valuation, per my observation, is whether PPHM will need to move its technology to commercial use without a partner or does PPHM get to grow their intellectual property aided by the financial and intellectual resources of a partner. A partner can choose to withhold their participation until an acceptable agreement is reached as can PPHM. However, applying more resources via partnering should accelerate the timeline to and extent of commercial success, just as rewards must be shared by more parties.”
Clearly this is the 64000 dollar question. My hope is that reason prevails and PPHM establishes at least one…preferable two partnerships…I hope soon…
“Have you worked in consideration of the portfolio of treatments for PPHM into your valuation base when discounting for risk and time?”
No…once I arrived at my current stated risk assessment of 15% to 30% I considered this investment to be relatively “Low Risk” and that was good enough for me.
“Which PPHM activities would you rate as independent for enhancing value and writing down risk?”
All of the ones you have annotated already…!!!
Enenon…
Before I respond to your points I would like to know more about the sorting tool that you are using. Is it available publicly? Can I get a copy of it?
Now in response to your points:
Please note in RED
1. USING THE CORRECT EV/EBITDA value when analyzing the Company
You are likely using the wrong Multiple Value for EV/EBITDA (of 11.54). This is why I do believe your value is incorrect:
1.1 You are using the industry average which also includes no-revenue generating Companies as well as sub $1b Mcap Companies.
The source I used was:
people.stern.nyu.edu/adamodar/New_Home_Page/datafile/vebitda.html
There are companies in that list that ”also includes no-revenue generating Companies” But you should be aware that any company that has no or less revenue than expenses will have a negative EV/EBITDA. Removing them from the list would only make the average go up not down.
1.2 Since at this stage we are assuming PPHM will succeed, we have also to assume PPHM in (as you said) 7 years or (as I said) 10 years from now will generate substantial revenues (i.e.> $1b). Of course, if you include the start-up / early stage Companies ... your multiple will be biased upwards. We are however assuming PPHM will be a "Mature" company in 10 years. This is why we should use the EV/EBITDA Multiple currently applying to Mature Companies.
There were two categories that apply; Biotechnology and Pharma/Drugs. I selected the more mature Pharma/Drugs (11.54) over Biotechnology (22.87). As I pointed out above; negative numbers make the average go down not up. I in fact agree that PPHM should be more in the Biotechnology sector than Pharma/Drugs in that Biotech’s profit margins are generally higher than Pharma/Drugs companies. Some of the companies in that list just stamp out pills at single digit margins.
1.3 You might want to use the Multiple of the Biotechnology Sector ... rather than the Pharma & Drugs Sector
See above.
1.4 You might want to use the EV/Sales Multiple rather than the EV/EBITDA Multiple. The former is way more stable / reliable ...
There are quite a few standard measurements available to the investor. If you use the same assumptions on the same entity you should arrive at a somewhat similar EV. Please justify the statement that EV/Sales is more “Stable/Reliable” than EV/EBITDA or for that matter EV/R. A quote from Investopedia “Generally the lower the EV/sales the more attractive or undervalued the company is believed to be.”
P/S
www.investopedia.com/terms/p/price-to-salesratio.asp
EV/EBITDA
http://www.investopedia.com/terms/e/ebitda-ev-multiple.asp
And here’s another way to evaluate an enterprise EV/R
http://www.investopedia.com/terms/e/ev-revenue-multiple.asp
In reference to your two screen shots; in order to compare apples to apples…As I stated in the beginning of this post, I would love to be able to use your sorting tool.
I note that you summary contains a company who’s EV/Sales is .92
With the above quote from Investopedia and this one “The EV/sales measure can be negative when the cash in the company is more than the market capitalization and debt structure, signaling that the company can essentially be bought with its own cash.” YOUR SELECTION OF EV/SALES WOULD BE THE WORST POSSIBLE CHOICE. THE QUESTION WAS NOT…WHAT IS A GOOD CANDIDATE TO BUY ON THE CHEAP.
2. Estimating the Correct Market Potential / Addressable Market.
I’m OK with using the CITIGroup estimate. I noted their number as well in my post.
5. To Estimate the BAVI Platform (all indications) today you need simply to guess the Market Share BAVI products will get in the Immune system cancer drugs market & the Probability of Succeed.
OK…a simple difference of opinion. Your 20% vs. my ~30%...And not that much…!!!
Unfortunately even with reading glasses I find the font too small but the question remains: What is the formula/macro in the cells that produce those results?
Assuming a Outstanding share basis of 200m (10% additional dilution) the fair PPS would be:
I used the total authorized share count of 325M…
So, if you consider that pphm (as you also said bofore) ... does have a 20-25% probability of succeeding. Then the fair value per share ... today ... should be between $10.62 and $13.28
Which is why I requested clarification & detail in the last post “Please justify the $20B valuation and the 10 year time frame” And “2 – “3. The probability weighted value of PPHM is therfore $3b in 10 years.
Please explain”
This is where our views differ the most. I think that it would be very useful to amplify and dissect these numbers and mine.
1. You mixed up sales and EBITDA ... you used the Sales Figure when according to your formula you should have used the EBITDA Figure.
We both may be wrong…!!! Based of Investopedia’s definition perhaps we should be using EV/R
2. The valuation model you presented does not exist anywhere. If are able to quote any Academic/practice source ... using this model ... I will be more than willing to have a look at it. I think it is just in your mind. Do you have any link where I can study this model?
Such a model .. .simply does not exist ... this is why it is wrong (and not only IMO).
You are correct that this model does not exist. It is a simplification of Discounted Cash Flow Approach. Defined below (Not for you but for those that are reading this and wanting a clearer understanding the process)
The Discounted Cash Flow (DCF) Approach
In this approach, the value of the company is measured by estimating the expected future cash flows, and then "discounting" those future flows by the desired rate of return in order to determine the "present value" of the future cash stream.
True economic value is better measured by more objective net cash flows. Valuation focuses on the risk-adjusted discounted stream of future cash flows.
The DCF approach measures the value of a company by estimating the expected future cash flows, and then “discounting” those future cash flows by the buyer’s required rate of return in order to determine their present value.
Two important aspects of DCF analysis include:
• How an appropriate discount rate is determined; and
• How the value beyond the short-term forecast period (“residual value”) is determined.
The discount rate must be such that it will reflect the relative levels of business and financial risk. An appropriate discount rate can be derived from two factors: the “risk-free” rate of return (as with government securities) and some premium for investing in the risk of a business venture. Individuals who purchase businesses that have a high potential for success will usually look for opportunities with a minimum of 6% to 8% premium over risk free investments. Why? Because they are usually borrowing money at risk-free rates plus 2% or 3%. The spread between their cost of money and required rate of return then becomes very small.
Half way through my assessment I realized that I am not trying to evaluate a company to determine if I would buy it and assuming that I would need to borrow money in order to buy it and that I needed to account for that borrowing in my calculation and there’s more. The two thing that I wanted to do were and still are:
1 – Try to estimate the value of PPHM in the future and
2 – Determine whether the current price in undervalued or over valued.
3. A B C D? ... please compute all the operations so that I can see how your valuation model works.
After looking at it again I can understand the confusion. I’ll try to be clearer. I originally wrote:
The equation looks something like this: $138B X .2 = A, $138B – A = B (7 years away EV), B X .2 = C, B – C = D (6 years away EV)…You get the picture…!!!
In English…Take the projected EV or Revenue (In my case $138B) and discount it by 20% (The product is the value A ($27.6B) Next step subtract that 20% discount (A = $27.6B) from the start point ($138B) the result is the discounted by 20% EV for the previous year (B ($110.4B) in this formula. Now start with B ($110.4B) and do it all over again until you get to you current year.
I thank you for your responses and look forward to receiving some of the details I requested.
Regards
golfho
To All that replied to my post...
It is now 6:00PM local time...
The bottle is opened...
I committed to NOT posting under the influence...As best I can...!!!
I thank all that have replied and I will reply tomorrow...
Ohhh...How I miss my youth...
Hoot all night with the Owls...
And soar with the Eagles in the morning...
Regards
golfho
I beg to differ…
First lets look at NOTBOB17’s original question:
NOTBOB17
“OK! Let's increase the entertainment value of this board! Give me an amount for which YOU would sell PPHM in its entirety. Let the games begin!”
Simple question…But then we must make several assumptions. Correct me if I’m wrong but from your post I gather that your understanding is; what value do I put on PPHM today? I got that from this:
“---> you should however be aware of the fact that a $100 price would imply a $18b valuation! ... It simply makes 0.0 sense right now!”
I would agree that “NOW” as in today or the next few days that that valuation in impossible.
The question was…
“Give me an amount for which YOU would sell PPHM in its entirety.”
I also did not address that question verbatim as well, because I do not manage the company and would not sell it anytime soon. As a matter of fact I will never sell all of my shares. I will keep a token amount for the rest of my life. I’ll explain at the end of this post.
I started to write a post several weeks ago but, never finished it. It addressed this very question of what is PPHM worth now and in the future.
It differs significantly from yours.
First, what do we agree on? I have posted, almost exclusively about two things, the chance of success (RISK) & the reward. I put the chance of success at between 15% & 30% and you @ 22.5%. Perfect. Though I don’t understand your process. Mine was reposted recently.
Now for where we differ:
1 – “1 YOU HAVE A 25% (**) probability that PPHM will be worth $20b in 10 years (if BAVI really works!!!) “
Please justify the $20B valuation and the 10 year time frame. Before you think about that please read my evaluation further down in this post.
2 – “3. The probability weighted value of PPHM is therfore $3b in 10 years."
Please explain
3 – In my assessment I used a more conservative discount rate of 20% vs. your 15%. But obviously we started out with a hugely different future EV (Market Cap)
THE NEVER POSTED POST:
It’s time to revisit the question of…What is Bavituximab worth…and when?
Last week I wrote:
“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 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.”
One of the most often used mechanisms that analysts use to evaluate an enterprise is to look at future earnings and then discount that by a certain percentage, times the number of years. 20% per year is the most often used discount. I applied that to the above estimate to arrive at a number that represents a value that PPHM should be at some time this year. The equation looks something like this: $138B X .2 = A, $138B – A = B (7 years away EV), B X .2 = C, B – C = D (6 years away EV)…You get the picture…!!!
So the calculations yield the following:
6 years to market cap equates to $58B for 2014
8 years to market cap equates to $37B for 2014
EXCUSE ME…!!! WHAT THE F***
Wait one freaking minute…
$58B divided by all of the authorized shares is $178 per share…!!!
$37B divided by all of the authorized shares is $113 per share…!!!
That just can’t be…!!!
OK…So let’s divide the target EV in 6 to 8 years by half.
That means that Bavituximab will be valued at the approximate value of Avastin when Roche bought the other half of Genentech…$65B…
OMG…
$65B would yield a EV of…
6 years to market cap equates to $21.3B for 2014
8 years to market cap equates to $13.6B for 2014
$21.3B divided by all of the authorized shares is $65.50 per share…!!!
$13.6B divided by all of the authorized shares is $41.85 per share…!!!
OK…So you say…Poor golfho…Has lost his marbles…
Maybe…Or…Maybe Not.
Let’s review.
Over a decade ago Dr Thorpe discovered that:
1 – PS is exposed on dead and dying cell. That exposure suppresses the immune systems response
2 – PS is exposed on most cancer cells and their blood vessels
3 – PS is also present on most enveloping viruses
4 – He then developed an antibody…actually several that attach themselves to the exposed PS
These Mab’s have been tested in 17 FDA approved clinical trials on ~500 patients. One was terminated (Prostate) and one was stopped (1st line NSCLC). Several had results that were somewhat unimpressive. Several had VERY impressive results. These VERY Impressive results were achieved in some of the most difficult to treat cancers.
During that time PPHM has refined its understanding of the Anti-PS MOA and has had that MOA validated by independent KOL’s.
Investigations into anti-viral are resuming.
So…Who does not see this as…ABSOLUTELY DISRUPTIVE…PARADIGM SHIFTING…technology…???
I see it as such…And yes there is, as far as my risk calculations are concerned a 15% to 30% chance of success.
Before someone post…Lets get to $3.00 or $4.00 first I would like to clarify.
What the above mathematical analysis states is…If a company will have an estimated revenue/EV in 6 to 8 years it should be fairly valued this year at X
So why are we at ~$2.40?
1- Uncertainty as to whether the science will be validated
2- Uncertainty as to whether the company can finance this effort to completion and no clarity on partnerships.
3- Uncertainty as to whether competition from other entities can diminish Bavituximab’s market share.
4- Hedge Fund’s market manipulation
5- Powerful interests actively working to slow/kill PPHM.
I’m sure I missed a few.
One last note:
Why won’t I sell all of my shares ever…?
Because I have a vision…Many years from now…I’ll be sitting in my rocking chair…Great grandchildren sitting around talking about life and the market when one asked…Did you hear that PPHM announced another forward split? Grandpas eyes light up. He slowly walks to his den and a few minutes later reappears with an aged slightly yellowed Scottrade statement. He sits down and softly says…I bought that stock at 29 cents…I still have some…Everyone turns to look at grandpa. A sad look on their faces…Someone whispers…Maybe it’s time we send him to that Home…Grandpa hands over the statement…His eyes slowly close…there’s a smile on his face…You couldn’t get rid of that smile with a jackhammer.
Regards
golfho
Oops...
purpledawgs, jonnyrocket...
It was the Cabernet...I swear...It was the Cabernet...
House...Club...See how similar they are...??? No?
OK I promise to not post anything with a glass of wine in my hand...For the rest of this week.
Dia, I agree that in the larger definition of Asia, India would be included. I was influenced by the qualifier Pacific in the statement and chart.
I realize that several people put forth Dr Reddy as a possible candidate.
I guess we'll know "In a few months"
Regards
golfho
My apologies for not responding immediately…I needed to attend to some personal business.
Geo, there is more to my response and now there are several more responses to my post
In order to not make this a long winded post or post multiple times I will incorporate my thought and respond to posts in time order.
Hypi’s post:
WRT options granting…There are several posters who feel very strongly about the implied self serving nature of management & the BOD. Too that I say…How many Sister Theresa’s are there in corporate management…? Lawsuit…maybe…
Liver data…I’ve been vexing over this for a while. Where’s the data from the PII part of this trial… Where’s the data from the PII part of this trial… Where’s the data from the PII part of this trial…
Tomorrow’s presentation appears to be addressing only the safety portion of this PI/PII trial. I would be pleasantly shocked if we hear anything about the PII efficacy at this presentation.
INTERESTING CHART OBSERVATION…
The Pipeline chart in the Bavituximab overview section of PPHM website is indicating that the trial is ~25% complete. It appears that they periodically update these charts.
My hope…Late breaking abstract at ASCO.
“Why partnering hasn't already occurred and/or what is this the biggest challenge in this area?”
It’s complicated…
“Well bought more yesterday and I do feel we have bottomed in this range.”
I hope so…!!!
Dia’s post:
By strict geographical interpretation India should not be included…But who knows…FWIW I would prefer a Japanese company.
Sunstar’s post:
Here’s how I see it…Regional partnerships. Liver & BC will be the next indications to be advanced. Asia Pacific to be allocated to one entity, E.U. another, the U.S. for PPHM…Or something like that.
PS to Hypi…
Several years ago I responded to one of AF’s articles…I laid out several inaccurate statements that he made in his article. He called me an idiot then as well…Take heart…This idiot fills comfortable in your company.
PSS to all of the longs
In early September 2012 I anticipated going to the ASM that October. We all remember that painful time. Jonnyrocket suggested a meeting at the Strip Club for those investors that were in the NYC metro area. I hope that this year will be the year…
PSSS…
I would like to attend the ASM this October…But October is the time that I’m preparing to pack up and heading down to Florida for the winter. If things work out the way I hope…I am WAY looking forward to meeting all of the LONG SUFFERING “LONGS” regardless of the scheduling issues.
Regards
golfho
PSSSS…
The last few paragraphs were written under the influence of some serious Cabernet…
Something like that...EOM
“how do you think of enrollment form sunrise trail, only 12 sites until now ? not as much as i thought or not ?”
I’ve been thinking about that as well.
Here’s my 2 cents… FWIW
I’ve been tracking the trial sites and posted about it in my post #163655
“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”
NOTE:
NO ex-US sites. Why?
In the previous PII trial there were:
24 US sites
2 Georgia sites
15 India sites
7 Russia
5 Ukraine
So…24 US sites and 29 sites in eastern Europe & India.
I would like to bring to everyone’s attention what Steve King & Shan have stated TWICE.
“We also remain on track with our regulatory and ethics approval timeline for rolling out European and Asia-Pacific sites over the next few months.”
In slide 16 of the Roth Presentation:
“Single Phase global registration trial >100 sites (US, EU and Asia Pacific)”
To me that is one giant tell…!!!
1 – E.U. That in NOT Russia, Georgia or the Ukraine.
2 – Asia Pacific is NOT India.
Hmmmm…
What could that signal?
1 - There will be a E.U. partner
2 – There will be a Asia Pacific partner
NOTE: Slide 19 lists many powerhouse E.U. BP’s & we have our Asia Pacific candidate in Takeda
When…? ”Over the next few months”
With 2 BP’s we get the long awaited hockey stick.
Regards
golfho
A request to the board...
I have been trying to register with Seeking Alpha since last night so that I can read the transcript. I have sent them an e-mail but they have not responded yet.
Could someone please post the full transcript.
Thanks in advance
Regards
golfho
I am sorry for your loss. One day soon we will be rid of this scourge. Stay strong.
Regards
golfho
IN LIGHT OF WHAT HAS TRANSPIRED TODAY...
I think that it's time for...
Another...
No PM...
But Thanks Loof...
Funny...No...?
Regards
golfho
Thanks...EOM