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"Bavi targets and covers the PS. It is then that the immune system recognizes these cancers and viruses as foreign..."
Sunstar, in my understanding as well, this statement is the key point. By blocking PS, Bavi blocks the ability of PS to send out certain chemokines and other signals that cause the body's immune system to overlook cancer cells and viruses as the pathogens that they are.
When a cell dies a normal death and breaks up, it releases proteins from inside the cell that the body would see as pathogens that should be attacked and destroyed through an inflammatory immune response. But this would be a bad thing if our immune system went into attach mode every time normal cell death occurred.
So to prevent the immune system from going into attack mode just because some unfamiliar proteins are released during normal cell death, the body has developed what scientists are now calling the "immune escape" process. The key player in the immune escape process is exposed PS. When the immune system sees exposed PS, it is given the signal to go away and not start an inflammatory attack response.
"Immune escape" is a wonderful tool to protect us from unwanted immune responses in the case of normal cell death, but over time the bad guys, i.e. cancer and viral pathogens, have co-opted the immune escape process and used it to protect themselves and prevent the immune system from recognizing cancer and virons as pathogens and then going into inflammatory attack mode to destroy them.
So by attaching to PS and covering it up, Bavi prevents PS from sending out "immune escape" chemical signals. Once the immune escape signal has been blocked, the body's immune system is able not only to attack and destroy the cancer or viral cell, but also to trigger an "adaptive immune response" whereby the immune system recognizes this cancer cell or virus as a bad guy next time it is introduced.
Thank you Mojo-- Together your two posts make a very compelling and encouraging point.
Let's remember that the Feb 4 PR reporting early results in the Ph II lung trial said that after just four of six treatment cycles, one of the patients already had a "complete tumor response, according to RECIST criteria."
If even one patient had a CR when the treatment protocol was only 2/3 complete, that's a pretty good sign that Bavi plus carboplatin and paclitaxel do an excellent job of knocking back tumor size.
As your post 44082 makes clear, if tumor size has indeed been knocked way back, this bodes very well for a big extension of Overall Survival times.
Thanks for connecting the dots for us ... This may explain why Management acts like they've got a rabbit in the hat and why the likes of Garnick and Chabner have joined.
Would it be so difficult to come out and say what their plans are for the chimeric and humanized versions of Bavi?
I thought they announced quite clearly their plans to take chimeric Bavi into a Ph III trial in the PR on Dr. Chabner on Aug 31. Actually C.J. already underscored this announcement in his Post 42053, below:
Posted by: cjgaddy Date: Thursday, September 24, 2009 10:20:29 PM
In reply to: Tandberg1 who wrote msg# 42051
PR 8-31-09: ONCOLOGIST DR. BRUCE CHABNER ADDED AS ADVISOR
"Bavituximab's novel mechanism that enables the patient's immune system to attack tumors more effectively combined with its natural synergy with chemotherapy
make it an intriguing and promising new approach to treating solid tumors," said Dr. Chabner. "The early clinical data on bavituximab is encouraging and I look forward to assisting Peregrine as they advance the bavituximab cancer program into later-stage trials in a number of indications."
http://tinyurl.com/lma24x
= = = = =
EARLY STAGE TRIALS = Phase I & II
LATER STAGE TRIALS = Phase IIb & III
C.J. It's important to mention that the other fully-human MAb developed by Affitech, i.e. PGN632, is in fact one and the same as PPHM's MAb 11.31 that Duke and Haynes and 11 other research institutes around the country are exploring in their anti-viral work.
I'm not sure everyone gets it that the dramatic results for 11.31 (it blew all the other known broadly-neutralizing antibodies off the chart) presented at the 2008 Capetown HIV conference by Haynes and Moody, which were submitted to Nature Medicine in Feb or March 2009 for publication in an upcoming issue, are also the results of PGN632.
A scientist friend who is also a shareholder sent me these abstracts this morning from the bavi cliinical trials. There is no mention whatsoever of a HACA (Human Anti-Chimeric Antibody) response being a problem, so whatever HACA they’ve measured (which is to be expected of course with a chimeric mab) does not seem to be a problem.
But still, humanized is best, and it’s nice to see Thorpe getting more funding for new humanized mabs. Like you said WH, would you expect Thorpe's application for funding to develop fully-human anti-cancer Bavi to say "The current chimeric version of Bavi is working perfectly ... but give my lab more money anyway."
So here are the actual toxicity results for Bavi as reported in the official abstracts. So now everyone, including Jessme, can see for themselves that Bavi has had no safety issues or adverse events that would prevent Bavi from becoming just as successful as other chimeric antibodies like Rituxin and Erbitux that are currently on the market, are generating hundreds of millions in sales, and are also immunogenic.
Here is ASCO abstract 1080, (the bavi phase 1 repeat dose monotherapy trial).
Phase I study of bavituximab, a novel anti-phosphatidylserine monoclonal antibody in patients with advanced refractory cancer: Preliminary results.
Print this page
Sub-category:
Metastatic Breast Cancer
Category:
Breast Cancer--Metastatic Breast Cancer
Meeting:
2009 ASCO Annual Meeting
Abstract No:
1080
Citation:
J Clin Oncol 27:15s, 2009 (suppl; abstr 1080)
Author(s):
N. K. Ibrahim, L. Wong, L. Rosen, J. Shan; University of Texas M. D. Anderson Cancer Center, Houston, TX; Scott & White Healthcare, Temple, TX; Premiere Oncology, Santa Monica, CA; Peregrine Pharmaceuticals, Inc., Tustin, CA
Abstract:
Background: Aminophospholipid are normally expressed on damaged or apoptotic cells, as well as on the intravascular surface of EC of vessels feeding the tumor as a result of the tumor microenvironment (e.g., hypoxia, reactive oxygen species). Bavituximab (B), a novel monoclonal antibody against PS, has demonstrated preclinical anti-tumor activity by eliciting both innate and adaptive immune responses specific to tumor vasculature. Here we report preliminary results of the phase I study in patients (pts) with advanced solid tumors. Methods: This is a phase I, dose escalation, safety, tolerability and pharmacokinetic (PK) study, as well as to define DLT, MTD and/or maximum effective dose (MED) in pts with advanced refractory cancers. Planned cohorts of 6 pts, each were to receive 0.1, 0.3, 1 or 3 mg/kg. Escalation was permitted if mean cohort Cmax ≤ 65 mcg/mL and dose limiting toxicities (DLT) was observed in ≤ 1 of 6 pts. No premedication was planned or needed. DLT was defined as ≥ grade 3 drug-related adverse events (AE), ≥ grade 2 PT, or ≥ grade 3 aPTT. B was given as a 90 minute IV infusion (on days 0, 28, 35, 42 for the first two dose cohorts and 0, 7, 14, 21 for the third- and fourth-dose cohorts. Although not a study endpoint, tumor response was collected at day 56. Results: Data are available for the first 20 pts enrolled (10 breast, 3 colorectal, 2 pancreatic, 1 each of hepatocellular carcinoma, head and neck, melanoma, mesothelioma, and prostate cancer). Cohorts by dose: 0.1 mg/kg (8 pts), 0.3 mg/kg (6pts), and 1 mg/kg (6pts). Median age was 59 years and 70% of pts were females. (Q: see attached Excel file). No DLTs or drug-related severe AEs were reported. Common drug-related AEs were fatigue (7pts), nausea (6 pts), dry skin (3 pts), constipation (2 pts) and dyspnea (2 pts). All AEs were grade 1 or 2 and no dose relationship was observed. PK was dose proportional with mean serum Cmax of 2.3, 5.2 and 16.6 mcg/mL for the 0.1, 0.3 and 1 mg/kg groups, respectively. No accumulation of B was seen after multiple weekly dosing. Conclusions: Single agent bavituximab is well tolerated to date, with a predictable PK profile. Accrual of the last planned cohort is underway. MTD has not been reached. Final results will be available for presentation at the time of the Meeting.
And here is ASCO abstract 3005, the bavi & docetaxel phase II trial, 1st cohort:
Phase II study of bavituximab plus docetaxel in patients with locally advanced or metastatic breast cancer.
Print this page
Sub-category:
Antibodies
Category:
Developmental Therapeutics: Immunotherapy
Meeting:
2009 ASCO Annual Meeting
Abstract No:
3005
Citation:
J Clin Oncol 27:15s, 2009 (suppl; abstr 3005)
Author(s):
D. Tabagari, G. Nemsadze, M. Jincharadze, M. Janjalia, J. S. Shan; Chemotherapy and Immunotherapy Clinic Medulla, Tblisi, Georgia; National Cancer Center, Tbilisi, Georgia; Oncological Center of Adjarian Autonomous Republic, Batumi, Georgia; Tbilisi Oncological Dispensary, Tbilisi, Georgia; Peregrine Pharmaceuticals, Tustin, CA
Abstract:
Background: Phosphatidylserine (PS) is an anionic phospholipid normally present on the inside surface of cell membranes. PS becomes exposed on the outside surface of tumor endolethial cells. Bavituximab (B) is a novel anti-PS monoclonal antibody and has demonstrated preclinical synergistic antitumor activity when used in combination with docetaxel. Methods: This Simon 2-stage trial is designed to determine the overall response rate (CR+PR) in patients with locally advanced or metastatic breast cancer to a combination of weekly bavituximab (3 mg/kg) plus docetaxel (35 mg/m2) on days 1, 8, 15 of a 28-day cycle for up to 6 cycles. Following completion of docetaxel, weekly bavituximab is continued until progression or toxicity. If ≥ 6 responses are observed in the 15 pt enrolled to Stage A, an additional 31 pts will be enrolled to Stage B. Secondary objectives include time to tumor progression, duration of response, overall survival, and safety. Results: Data are available for the 15 female pts enrolled in Stage A of the trial. Median age was 49 years;13 had stage IV and 2 had recurrent/progressive stage III breast cancer at study entry. All patients received prior chemotherapy, 13 had surgery, 7 had hormone therapy and 5 had prior radiotherapy. Patients received a median of 6 cycles of treatment. All patients reported at least one AE, to date. The most common AEs (regardless of severity or causality) were alopecia, epistaxis, fatigue, back pain, diarrhea, nasal dryness, infusion related reaction, arthralgia, pyrexia, stomatitis and nail bed bleeding. Grade 3 drug-related AEs were back pain, headache, DVT (discontinued study treatment at week 3) and chest pain (SAE) starting during a docetaxel infusion, which recurred after completion of bavituximab, reported in one patient each. Using RECIST, the overall response rate in these 15 pt is 67% (95% confidence interval, 38-88%) for the intent-to-treat group and 71% (95% CI, 42-92%) for the 14 evaluable patients. All responses were confirmed at least 4 weeks later. Conclusions: Bavituximab plus docetaxel achieved an encouraging response rate in advanced/metastatic breast cancer in Stage A of this study. Enrollment in Stage B of the trial is expected to be completed with preliminary results available by the annual meeting.
Here is the HCV multi-dose trial abstract:
53 MULTIPLE DOSE SAFETY AND PHARMACOKINETIC STUDY OF BAVITUXIMAB IN PATIENTS WITH CHRONIC HEPATITIS C VIRUS (HCV) INFECTION
Eric J. Lawitz1, Eliot W. Godofsky2, Joseph S. Shan3; 1Alamo Med- ical Research, San Antonio, TX; 2University Hepatitis Center at Bach and Godofsky, Sarasota, FL; 3Peregrine Pharmaceuticals, Tustin, CA
Background: Bavituximab, an investigational monoclonal anti- body targeting phosphatidylserine (PS) located on the surface of virus infected cells and enveloped viruses, is being devel- oped as an anti-HCV agent. It has immunostimulatory effects in preclinical viral models. Single intravenous (IV) infusions of bav- ituximab up to 6 mg/kg were well-tolerated and showed tran- sient antiviral activity in chronic HCV patients. Methods: To determine the safety, tolerability and pharmacokinetics of mul- tiple IV infusions of bavituximab, sequential cohorts of 6 patients were given twice weekly 90 min IV infusions for two weeks at 0.3, 1, 3 or 6 mg/kg and followed until week 12. Vital signs, physical exams, safety laboratory parameters, serum bavituximab levels and serum HCV RNA levels were measured. Results: Twenty-four patients (15 male, mean age 49) were enrolled. Eleven were non-responders, 8 were relapsers and 5 were treatment-naïve. Mean baseline viral load was 5,000,000 copies/mL and 15 were infected with geno- type 1, 8 with genotype 3 and 1 with genotype 2. The infusions were well-tolerated. No serious adverse events (SAEs) or early discontinuations were reported. There was no dose-related increase in incidence or severity of adverse events (AEs). All AEs were mild or moderate and transient, except for grade 3 neck pain and arthralgia (drug-related) in a patient with a his- tory of joint pain at 3 mg/kg bavituximab and grade 3 ele- vated blood glucose (unrelated) in another patient with diabetes at 0.3 mg/kg bavituximab. All other drug-related AEs were mild: hypertension in 1 patient at 0.3 mg/kg, headache in 1 patient and headache and pruritis in 1 patient at 1 mg/kg and flu-like illness/symptoms in 2 patients at 6 mg/kg after the first infusion. Bavituximab reaches Cmax at 2-3 h postdose with a mean elimination half-life of ~34 h. Bavituximab exhibited dose-proportional increases in Cmax and AUC in single and multiple dosing and did not lead to significant accumulation. All dose levels exhibited on therapy antiviral activity (decline of >0.5 log10 reduction in HCV RNA). The 3mg/kg cohort had the largest number of patients showing antiviral activity, as 5 of 6 subjects achieved >0.5 log decline in HCV RNA. Conclu- sions: Twice weekly IV doses of bavituximab up to 6 mg/kg were safe and well-tolerated. Single-dose and multiple dose pharmacokinetics of bavituximab are linear, predictable and no accumulation appears to occur over time. Two weeks of dosing is indicative of antiviral effect in a proportion of patients. Future studies designed to optimize the dosing schedule and investi- gate combining bavituximab with current standard therapy are planned.
Here is the single dose HCV abstract:
127 PHASE I SINGLE-DOSE STUDY OF BAVITUXIMAB, A CHIMERIC ANTI-PHOSPHATIDYLSERINE MONOCLONAL ANTIBODY, IN SUBJECTS WITH CHRONIC HEPATITIS C Eliot W. Godofsky1, Joseph S. Shan2; 1Bach and Godofsky Infectious Diseases, Bradenton, FL; 2Peregrine Pharmaceuticals, Tustin, CA
Background: Bavituximab is a novel monoclonal antibody that specifically targets phosphatidylserine (PS) on the outer surface of the plasma membrane of virally infected cells and enveloped viruses. Once bound, it is believed to direct the host’s immune system to clear virally infected cells and viruses. Its antiviral activity has been previously demonstrated in animal models of murine cytomegalovirus and pichinde virus. Aim: To determine the safety, tolerability and pharmacokinetics of a single intrave- nous (IV) infusion of bavituximab in a phase I, open-label, dose- escalation study in subjects with chronic HCV infection who failed to respond to or relapsed after pegylated interferon plus ribavirin combination therapy. Methods: Sequential cohorts of 6 subjects were given a single 90 min IV infusion of bavituximab at 0.1, 0.3, 1, 3 or 6 mg/kg and were followed for 12 weeks. Vital signs, physical exams, safety laboratory parameters, serum bavituximab levels were monitored and serum HCV RNA levels were mea- sured by NGI SuperQuant. Results: The infusion was safe and well tolerated by all subjects. All adverse events were mild or moderate in severity, except for 1 report of severe headache at 1 mg/kg and 1 of severe vertigo at 3mg/kg, both unrelated to study drug. The majority of AEs were considered not related to study drug, with the most common being injection site bruises, nausea, rhinitis, and headache. There were no laboratory AEs except for expected subclinical transient prolongation of aPTT for the 3 and 6 mg/kg dose groups on day 1 postdose. After IV infusion, bavi- tuximab reaches Cmax at 1h postdose with a mean elimination half-life of
31h. There was a trend towards a bimodal decrease in mean serum HCV RNA levels. The first decrease was seen within 24 hours postdose and the second began around day 4 and ap- peared sustained up to several weeks in some subjects. Serum cytokine analyses are ongoing. Conclusions: Single IV doses of bavituximab up to 6 mg/kg were safe and well tolerated. It has a predictable pharmacokinetic profile. The transient reductions in serum viral load were consistent with the proposed mechanism of immune stimulation. Unlike conventional therapy, bavituximab is a unique therapeutic that targets viruses and virally infected cells by channeling host’s defense against them. Since it does not target viral proteins, bavituximab is unlikely to elicit traditional viral resistance.
Even with chimeric Bavi, the safety profile is so much better than Avastin that they will have no problem getting Bavi approved if the efficacy stays on track.
At the time of last year's ASM, SK told me there are several very successful, approved monoclonal therapies built on chimeric antibodies. (I can't remember the names he mentioned-- maybe someone else on this board knows the names.) Being a chimeric is not a limitation if the drug has good efficacy.
It's not the same story as Cotara. Bavi will go across the finish line as a chimeric. Then 11.31 will come along as a second generation cancer product after first proving itself as an anti-viral therapy.
Thanks C.J. Very helpful to have this distinction between Animal Rule and EUA.
From what you posted, it seems that under the Animal Rule we would still need to do a Ph I safety and PK/immunogenicity trial in humans if they decide to launch with the fully-human, 11.31 version of Bavi that Haynes/Duke have been working with.
I think the difference is that 11.31 is a "direct-binder" to PS that doesn't need to first grab beta-2 from our blood to complete the binding to PS. Since there is only a finite amount beta-2 available in our bodies, 11.31 packs more punch mg. for mg. than Bavi.
I suspect DTRA would want to go out the door with 11.31. So when will we see a PR announcing a Ph I safety trial in humans for 11.31? Or could DTRA already be conducting such a trial confidentially under the terms of their grant?
Thanks Sunstar -- Great reminder about EUA.
C.J. -- Could you please post again how many humans have been treated with Bavi. I would think that we are very close to EUA approval since we have treated so many humans safely in addition to all the monkeys that Haynes and DTRA have treated.
Can somebody please re-post the criteria for EUA approval. Thanks so much.
Often an employment agreement will say that options are lost unless they are exercised within xx days of receiving notice that employment has been terminated.
With Garnick on the team now, I bet he knows lots of high powered business development guys in BP who would love to take David King's place.
CJ-- Could you please re-post Slide 42 (?) from the R&R presentation, the one that shows anticipated milestones to be announced in 4th Qtr. I can no longer find the link to the R&R conference.
Thanks very much.
I'm just guessing, but when Moby said things "didn't pan out the way I anticipated" I think he and those behind him had big hopes on defeating the stock incentive plan with his talk about 15M shares not being reduced to 3M shares.
If the Incentive Plan had been defeated, a condition in Garnick's engagement agreement would not have been met. The defeat of the Stock Incentive plan would have indeed been a discouraging signal.
But just the opposite is the case. The Company now has plenty of incentives to pass out to several more world class players who will now join PPHM in the wake of Drs. Chabner and Garnick.
The migration of major league talent from BP to PPHM begins today. :)
The risk you face is massive future dilution of your ownership percentage, which should be a concern due to the 325MM authorized against the 47MM outstanding.
People seem to be forgetting that dilution affects PPHM Management just as much and just the same way that it affects PPHM shareholders. The shares that SK and ES own directly, and the shares underlying their options, will all suffer just the same as us if the Company issues new shares, i.e. dilution, frivolously or unnecessarily.
If the Company were still in the old mold of paying for all of its r&d expenses by issuing more and more shares, I would be concerned about the high number of unissued shares on the shelf.
But given how Avid is pumping out cash (and will pump even more when the gov't stockpiling order comes in), given the high prospects of another large gov't anti-viral grant, given the high prospect for a mega Cotara GBM license in the next 12 months, and given that PPHM Management doesn't want to hurt themselves by doing unnecessary dilution, ...
... I really can't get excited about this scare tactic any more than the fiction that the post-r/s Incentive Plan is for 15 million shares, not 3 million.
It's just amazing the tactics used on this board to scare people into selling so that someone else can accumulate a position at a lower price.
Hey Moby-- Now that the Company has officially rejected your fanciful spin on the number of new options in the Incentive Plan, would you please be man enough to post a correction to the misinformation you have so vigorously promoted on this board.
Thank you.
Often key executives start out technically as consultants for tax reasons (because it works better for them to be paid on a 1099 because they have already met the self-employment tax threshhold) or because their full-time contract with prior employer only allows "consulting."
In the last Company I worked for the COO was paid $300K/year pursuant to a consulting agreement that lasted a full year. The day after his employment agreement with prior company expired, he switched from being a consultant to an employee.
Moby-- rest assured you will see it. This is just the beginning.
With all the r/s and delisting uncertainties gone, Wall Street funds will want to get in on the ground floor as the price approaches $5.
Just a couple more solid Ph II clinical data releases, plus a gov't HIV funding PR and the Nature Med publication thrown in for good measure, and the $5 mark will be far behind us as this puppy soars.
Finally we are on the institutional radar screens. You can relax now. :)
Excellent point Dia -- You've given a very solid reason for why PPHM might want to keep such a large number of authorized but unissued shares on the books. If both the anti-cancer and anti-viral platforms are what we all think they could be, the time for a 3:1 forward split (to bring the price back from $60 to $20 per share) is probably only two years away.
Of course I was not trying to explain the question you answered. In my post 43098 I was only explaining that there are many companies who don't feel a need or a temptation to issue the extra shares of authorized but unissued stock they have in the cupboard --
... just like there are many individuals who don't feel the need or the temptation to eat all the food they have in the cupboard.
If the short-side's A Team has been reduced to these arguments, we are in great shape for next week !
The combination of (1) increasing Avid revenues plus (2) current $50 million shelf plus (3) another large government anti-viral contract, should be all that's needed to pay for operations and the first year of Phase III cancer trials.
Plus, (4) the prospects for doing a major Cotara BP license in the next 12 months are excellent. In another 6-8 months they will have more than enough long-term survival data to close the full-value Cotara GBM deal they couldn't quite close this summer.
So here's the answer: There are lots of companies that have millions of authorized but unissued shares that just sit there and never get issued because the company is able to fund operations from existing revenue sources like (1), (2), (3) and (4) above.
JGal-- You hit the Bullseye. My sentiments exactly, even though I was one of those caught last week wasting time in his labyrinth of verbal circles.
Indeed, it does augur well that the shorts are still using their A Team even after the r/s has been announced.
The PRs flowing during the next 10 trading days will be a rude awakening for many who are betting against this puppy. With the r/s uncertainty gone, it's time for the big firms to lock in a ground floor position. The Company has the news flow needed to seal the deal.
Enjoy the ride. :)
Moby-- I've got to go back to work now. I understand your point and respectfully disagree. I hope to reply this afternoon.
You say: " IMO if all the answers to your questions were YES, we wouldn't be at $0.63 right now."
IMO, If the answer were "no" and Bavi was not a breakthrough, world class scientists like Dr. Chabner would not be joining, Haynes would not be expanding the scope of his Bavi work, $60 million of r&d money would not be chasing Bavi at 11 highly respected institutions from the U.S to the U.K. and Brazil, and new hires at AVID and PPHM would not be soaring.
By now so much anti-viral work has been done with Duke and the 11 other institutions mentioned in the last PR that Management knows whether Bavi and 11.31 will work to control/manage HIV, influenza, military viral threats, etc.
If the answer is "yes", i.e. Bavi/11.31 does represent a major breakthrough in the war against viral disease, then AVID revenues will go through the roof from stockpiling contracts and the stock will soar, thereby allowing the Company to easily raise $50 million from its shelf offering with just a fraction of the remaining authorized but unissued shares. This will leave plenty of room to grant the 15 million shares included in the new option incentive plan and will allow the Company to wait until next year's annual meeting to seek an increase in authorized shares.
It comes down to the same old question: Does the science work or not? Is this a major medical breakthrough or not? If SK has what he thinks he has, there is a very good chance the r/s will not happen.
Moby-- The relevant language is in the 4th paragraph on page 13 of last year's proxy:
"The actual timing of the filing of the Amended Certificate with the Secretary of State of the State of Delaware to effect the Reverse Split will be determined by the Board. Also, if for any reason the Board deems it advisable to do so, the Reverse Split may be abandoned at any time prior to the filing of the Amended Certificate, without further action by our stockholders."
This means that that the Board can adopt resolutions [i.e. make a "determination'] on Oct 21 that the r/s is in the Company's best interest, but then change its mind and decide not to file the Charter Amendment that is required for the r/s to actually happen.
As I said to Realist a month ago, IMO the odds are still 50:50 that the r/s wil happen and 50:50 that it won't happen. With all the great work Management has done this past year, I would be delighted to see them award new option grants in the current $0.65 range on Oct 23, the day after the meeting, and then unleash a barrage of announcements starting Monday Oct 26 that take the pps over $1.00.
There are 13 trading days from Oct 26 through Nov 11. That gives them 3 days to get the price over $1.00 and another 10 days to see if it's going to stay over $1.00. If the continuous news flow keeps the price well above $1.00, no r/s would be necessary. If the pps drifts down during the critical 10-day period to a danger zone like $1.10, then the Company would have to effect a 1-for-3 r/s to keep the price up during the balance of the 10-day period.
Management does not want an r/s any more than we want it. They will lose the same wealth-building leverage that we lose. The most logical thing for them to do is grant low-priced options on Oct 23 (assuming the Incentive Plan is approved), and then take a wait-and-see approach during the 13 trading days from Oct 26 to Nov. 11.
Maybe the barrage of continuous news starting Oct 26 will do the trick to avoid a r/s --- and maybe it won't. Clearly it won't work unless the announcements include a major money deal like a Cotara BP license or another $40 million gov't grant for anti-viral work.
... and who knows, maybe the infamous Nature publication will come out in the online edition on Sunday Oct 25.
IMO
No r/s tomorrow.
r/s authorized on Oct 21, day before meeting.
r/s is not effective until Charter Amendment is filed in Delaware, which could be any time prior to Nov 11 -- or not at all.
Just because they authorize the r/s on Oct 21 does not obligate them to effect it. Read last year's proxy language. There are 13 trading days between Oct 26 and Nov 11. If enough good news was lined up and ready starting the week of Oct 26, I could see them take a watch-and- see approach. If the pps got over $1.00 between Oct 26-28, I could see them hold off on filing the Charter Amendment until the pps was at risk of falling below $1.00.
This approach would have the further advantage of allowing new options to be granted on Oct 23 with relatively low exercise price.
Jess-- I am sorry but you are revealing ignorance about the meaning of legal language. The words "in a manner satisfying Section 424(a) and 409A of the Code" mean that the "substitution" or "assumption" has to be an event that fits within the meaning of those same two words in Section 424(a). In the statute those two words are defined to have a very narrow meaning limited to: "...corporate merger, consolidation, acquisition of property or stock, separation, reorganization, or liquidation."
Go read the statute. Here's the link again: http://www.law.cornell.edu/uscode/26/usc_sec_26_00000424----000-.html
There are limits on one's ability to confuse and obfuscate on this Board.
Jess- There is no ability to price options below market value except in the very limited circumstances described in Section 424(a) of the Code, namely, following a merger,acquisition, reorganization or liquidation of the Company.
Here is the full text of the proposed Incentive Plan language you are complaining about:
"The exercise price per share shall be fixed by the Plan Administrator at a price not less than one hundred percent (100%) of the Fair Market Value per share of Common Stock on the option grant date; provided, however, that the Plan Administrator may fix the exercise price at less than 100% of Fair Market Value if such option is granted pursuant to an assumption or substitution for another option in a manner satisfying Section 424(a) and 409A of the Code.”
Here is the text of Section 424(a): http://www.law.cornell.edu/uscode/26/usc_sec_26_00000424----000-.html
Following the option back-dating scandals of recent years, the IRS adopted new rule 409A that imposes severe penalties for granting stock options with an exercise price below fair market value on the date of grant. No one fools around in this area any more. The language in the proposed Incentive Plan is technical lawyer talk to allow an exception for the remote circumstance where BP options are substituted for PPHM options as part of a takeover and the BP options carry a lower exercise price than the PPHM options in the substitution.
Bravo Wildhorses-- You make excellent points and you have the patience of Job in dealing with empty noise after empty noise.
WOW- Company confirms Bavi is now in development as THERAPY for HIV.
"Peregrines PS targeting antibodies are now under investigation as potential therapy for chronic HIV infection at leading HIV research centers in the U.S. and U.K."
This statement comes from the "Virus Infection Therapy" subsection of the new "Infectious Disease" section of the website: http://www.peregrineinc.com/index.php?option=com_content&task=view&id=84&Itemid=150
Before today we knew that Bavi was being investigated by Duke, NIH and others as (1) a possible component of an HIV vaccine program and (2) a possible HIV vaginal microbicide.
I believe today's new website has the first confirmation that Haynes and other collaborators are now investigating Bavi/11.31 as an HIV therapy that could be used directly to reduce and control viral levels in patients with advanced disease.
Dia-- My thoughts were running along the same lines. There is no need for Crucell / J&J to mention their interest in adjuvants like Bavi-- industry analysts are already doing that for them. Check out this comment on why Crucell is so well positioned to bring value to J&J in the influenza market:
"These latest movements in the booming influenza market translate into more intense competition. While Merck & Co is directly entering the crucial US market, both J&J and Abbott are set to emerge as new players in the increasingly commoditized sector. In order to gain or retain significant market share as well as prevent further price erosion, differentiation through new technologies, including adjuvants, cell-based manufacturing, needle-free delivery, and even universal vaccination and antibody strategies , will become more and more important for influenza players. Datamonitor believes that, by building on the Dutch vaccine maker's various platform technologies [AND RELATIONSHIPS, i.e PPHM] in this way, the new alliance between J&J and Crucell has the potential to make a significant impression in the influenza sector."
http://www.tradingmarkets.com/.site/news/Stock%20News/2557267/
Peregrine brings 3 of the 4 key differentiating factors highlighted above: Bavi is an adjuvant that appearst to enhance the efficacy of vaccines, Avid / Boehringer Ingelheim bring cell-based manufacturing to the table at a large scale, and Bavi represents a "universal" antibody strategy effective against all enveloped viruses.
With $440 million of J&J's cash now in Crucell's bank account, looks like Crucell is well positioned to do a little business with PPHM if that is what is needed to differentiate themselves from the rest of the influenza players.
Honestabe-- All I'm doing is connecting dots. When a Company is cash-strapped, it doesn't go on an 18% hiring binge unless it is pretty darn sure that new alliances or projects are just around the corner.
The new hiring suggests major strategic announcements are imminent. Whether that news comes out before an r/s, after an r/s, or in lieu of an r/s is anyone's guess.
WOW-- that means the work force of the combined enterprise will have grown by 18.5% in the 7 months from 3/18 to 10/18.
Sounds like a Company that is expecting significant near term growth. When you are low on cash like PPHM, you don't go out on a hiring spree unless you are darn confident about having lots of new work -- e.g. new cancer clinical trials to manage, more government anti-viral contracts to manage, new BP collaborations to manage -- to keep those new hires engaged.
Thanks C.J. ... The fuse is lit !!!
KT-- Exactly what I was thinking:
"Moby, your outrage about the PP and the amplification it is getting on this board is a clear reinforcer to me that PPHM management needs the PP to achieve best negotiations with those that might have interest in the PPHM technology but don't want to pay a fair market price for it."
Without a PP, it's easy for the Mobys and Jessmes of the world to throw stones at Mgmt., rock the boat, and create so much uncertainty that the price does indeed fall as a result of their self-fulfilling prophecies. The PP protects against that scenario and they hate it.
I am thankful that Mgmt. is so competent. They have done huge amounts with very few resources, e.g. created an anti-viral company out of thin air with gov't and Duke money, become nearly profitable through AVID, etc, etc.
But I am equally thankful that they are ENTRENCHED. Bravo for the Poison Pill.
Hey Realist— Why no response to my posts 42020 and 42023?
Surely the reason why you think a r/s is such a big deal is because you believe it will lead to a decline in PPHM market cap. Now is when all of us inexperienced PPHM investors need your leadership. We need you to show us that you really do believe the market cap will fall to pieces after the r/s as you predict. If you really believe no Bavi Phase III is coming, then you should be willing to wager on it.
If you believed any part of what you post, it would be like taking candy from a baby for you to win this bet because it’s not even based on seeing a decline in PPHM market cap. Instead, it’s based on seeing the pps (adjusted for any r/s) grow at less than a 12% annual rate. Surely you don’t believe PPHM’s returns for investors over the next 9 months will come anywhere close to achieving such outstanding results.
If you are more than hot air, stop trying to change the subject and just take the bet. Are you really that afraid?
I will be travelling for next 3 days but I will look for your reply on my return Monday.
Realist-- I forgot to build into our wager an assumed rate of growth to make the bet more attractive for you.
In today's lousy markets, anyone would be very pleased with an investment that yielded 12% annual growth. That's 1% per month, or 9% over the 9 months between now and ASCO.
So to be more precise, here is the wager. I win if the PPHM market cap has increased more than 9% between now and end of ASCO and you win if the market cap does not achieve such an exceptional growth rate.
Again, how much money do you want to bet, or are you just hot air?
Realist-- I see 50:50 odds that the company will effect a r/s before the annual meeting. Anybody who doesn't get that isn't paying close attention to the Company's many public statements.
The more important question is what will happen to the market cap six months or a year from now. Between now and ASCO in June there will be so much cancer Ph II data, anti-viral developments with 11.31 (the subject of the famous Duke/Haynes paper) and AVID news that I'm expecting more appreciation in my PPHM holdings (with or without a r/s) than I could get anywhere else in the market over the next 9 months.
If there is a r/s the shorts may or may not be able to drive the pps down for a few months. But over the course of the first half of 1010 the combination of AVID revenue growth, gov't support for 11.31 anti-viral programs and completion of three Bavi Ph II cancer trials and the start of the Phase III trials that Dr. Chabner is working on, will IMO bring in much more institutional buying than short selling.
If you want to bet that the PPHM market cap will be lower following ASCO 9 months from now than it is today, I would place money on that. I have low trust that you would stop posting if you lost the bet, so I would prefer that we each put cash in a neutral escrow account. How much do you want to bet?
Jessme-- Maybe you should email Dr Chabner and find out what he finds so compelling about PPHM that he would wrap his world class reputation around this toilet.
Excellent point Hayward. I was thinking of B.I. as the enabling alliance for long-term, high-volume commercial production of Bavi for cancer therapeutics on all tumor types.
But you are right-- the near-term implications for gov't stockpiling of 11.31 for multiple anti-viral applications are just as important.
This alliance will allow AVID to attract larger, high volume customers. In the past AVID has been known as a high quality R&D facility that could help small biotechs through the protein development and clinical trial phases-- and perhaps early-stage, low-volume commercial runs.
With this new B.I. alliance, AVID will be able to attract clients who are already in Phase III and are looking for a seamless manufacturing know-how link to large scale production runs.
I suspect this new alliance nearly doubles the type and number of clients who would be interested to work with AVID.
Probably most important is the access PPHM now has to B.I.'s high volume production facilities as Bavi and 11.31 take off.
With a world class, major league player like B.I. as part of the PPHM team, suddenly it's credible when SK tells BP: "We are ready to go it alone with Bavi and 11.31 if you don't want to pay top dollar."
One-by-one Management is putting together all the pieces of a Company that is "Built To Last."
I feel so special that the same little post could have pushed hot buttons on both Jessme and Realist. So I will repeat the post-- this time with the proper IMO qualifications and with my apologies to ES for an ungrounded and completely speculative outburst.
Over and over it seems like someone allows the stock to fall during the middle of the day, arguably so that he can pick up more shares cheaply, and then closes the pps up at end of day, arguably because he is long and wants to maintain a steady support of the stock in the 70's because his long term goal is to see it go over a dollar and avoid a r/s.
Until the big PRs come out in early Oct. (which IMO is a safe assumption based on Slide 42 of the R&R presentation and Mgmt's stated desire to avoid a r/s), he might as well profit from all the bashing and accumulate as many cheap shares as he can during the middle of the day.
IMO someone big out there with a lot of buying power has been paying close attention to the PRs, the CCs and the R&R presentation and has realized from these public disclosures, as have I, that it is very likely the Company will release a flurry of PRs in early Oct. that will render the r/s either unnecessary or of no consequence if it does happen.
The last two buy orders at 4:00 pm were for a total of 15,816 shares. I guess you can call it either thick paint or a legitimate buy.
Over and over it seems like someone allows the stock to fall during the middle of the day, arguably so that he can pick up more shares cheaply, and then closes the pps up at end of day, arguably because he is long and wants to maintain a steady support of the stock in the 70's because his long term goal is to see it go over a dollar and avoid a r/s.
Until the big PRs come out in early Oct., he might as well profit from all the bashing and accumulate as many cheap shares as he can during the middle of the day.
Who is ES feeding info. to? Someone out there has a lot of confidence in this stock, and shows it at the close every day.
Mojo-- Thanks for the provocative post. It seems the CC on 9/03/09 did fill in some of the gaps.
Compare what SK said on 5/15/09:
“We’re not in a position to move bavituximab forward as aggressively as we would like,” King said. “We have set up a number of meetings at ASCO with potential partners and investors to see if we can accelerate things.”
To the following 3 statements Joe Shan made in the CC on 9/03/09:
"Now, based on the encouraging signs of anti-tumor activity already seen in our current Phase II trials, WE HAVE BEGUN PLANNING NEW TRIALS to further advance the clinical development of bavituximab."
"we look forward to his [Dr. Chabner's] contributions to the next stage of the clinical program."
"In addition to Dr. Chabner, we are also expanding our outreach to key opinion leaders & industry experts to help us FINALIZE our next clinical trials, and I look forward to sharing with you our plans going forward in the coming months."
What a difference 4 months makes. It certainly seems like the Company would not be wasting their own time, let alone Dr. Chabner's time, designing Bavi Phase III trials if they had not found some new money/alliances to pay for the "key opinion leaders & industry experts" who are helping to "FINALIZE our next clinical trials."
Anyone want to place odds on:
a) Mass General Hospital / Harvard Medical, under Dr. Chabner's direction, will be one of the trial sites for the Bavi Phase III trial.
b) the PR announcing the Bavi Ph III trial will be released in October as part of management's program to boost the sp.