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First and foremost I want to wish my fellow pphm investors a happy and healthy thanksgiving. As we sit and wait for the final phase towards the finish line of approval and look to make a decent amount of profit should this gem take off the way we all hope it does I ask every single one of you who are heavily invested like I am will you be willing to join me in giving back to those who are battling and struggling with this horrible thing called cancer. I personally would like to give back and would like and ask you to join me and let me know if you are willing to give back like me? Please let me know as I arrange to set this up. Thank you again and God bless every single one of you. Thomas
Quick question anyone who wants to give a honest opinion and not one that is inflated or deflated for that matter. With excellent sunrise results and then approval what do we consider the potential of this stock? My opinion right now after sunrise and then approval I believe the stock should be between 15 to 20 dollars. Anyone have a ballpark? Thanks as always for the great knowledge of some.
I agree with bcs and others but wouldn't it be great to say it may be for leverage of a partner hey after all that alone may make the pps go up? Hmmmmmmm
Yes or no? While I am still undecided and continue to read and way my option my gut feeling is to vote no no no. Why? I listen to both sides of the coin and yes their are valid points on both sides as this usually is the case in life. However throughout my investment I have read listened and learned alot regarding the science and being in the medical field I am a firm believe in the science and bavituximab. Based on that I believe bavituximab will be approved and a vital part of cancer treatment. Now to the point of the vote although I listen to both sides and once again both sides have valid points. One point I heard is why at this point cripple them at the knees? Well personally at this point why have your share holders crippled at the ankle? Since my investment on paper I am down over 250 grand and this is where I state why I personally from my gut want to vote no. Management all year plays the secret card and treats the shareholder as a clinical blinded trial giving no information what's so ever(secretive) understandable ok I will say for protection. But then you ask me to vote for 175 mil more shares and got the nerve to tell me it will cost 125 thousand more half of what I'm down if they have to have a special vote. Now your willing to give me information on how much it will cost for that special vote why can't you give me the slightest idea what the shares are for? You can thank me at the end of your cc for our support but you can't treat me like you mean it? Still deciding on my vote all my opinion.
Question? Maybe someone could help me and answer. Who is in charge of updating Wikipedia? Would it be the company peregrine? Or can anyone from the general public update it? I'm curious? Thank you for your time if anyone can please answer I would appreciate it?
Curious? What are you hanging around for? Everything is negative? Really? Everything one writes you find something negative about it. How's that possible? That's an amazing task one takes so much time and energy to involve them self in. Expecially when one just spends their time telling everyone else how negative and useless their investment is. I say anyone who is truly invested in this stock will hope for the best outcome in the long run and can clearly admit that there is negative and positive signs at current. Nothing here is fully negative or fully positive.
Please anyone chime in and help me here. Help me try to understand this clearer as my head is spinning never mind hurting and my account on paper says you are down 260 grand. Yes I said grand not dollars. Scary scary scary for me. Hard earned money. Anyway please help explain. In order for me to buy at 1.05 let's say that means their has to be someone selling at 1.05 correct?? Then for it to be at lets say 1.04 or 1.03 again it means someone is selling at that price??? Correct?? Now what is mind boggling to me is why? Why? Why? With all the recent I would say progress collaborations with top notch hospital and company and so far into a phase 3 would anyone sell at these prices? Why? Wouldn't one at least at this point hold? That's what's driving me nuts. Maybe call me stupid for not selling a single share. However something here just does not add up. Who is really selling at these prices? Who is really driving this down? I mean really anyone honestly could say the news recently has been positive for the most part. This late in the game this close to a final who wants to be a millionaire answer you don't start selling or running. You at least hold?? No? Am I wrong? It really makes me start believing some big company or some big entity is trying and at this point succeeding at holding this thing down. It just don't add up for people to sell at these prices? So does anyone have a opinion why so low? Why would anyone sell at a loss? I know anyone selling right now sure did not make a profit. Yes I'm scared yes I'm down a huge chunk. However I still have such confidence a huge amount of confidence that I have kept every single share and will till success. When whoever is playing tug a war finally gets stuck in the mud and the rope breaks and bavi is approved.
Your down on paper as a loss of over 250 grand also? You feel my pain and concern for sure. Please bavi lets get a move on. I believe in the science and it works and will be approved. But really get the ball rolling not bouncing.
Wow honestly that's good down 250 grand on a 300 thousand position imagine the concern and heart ache. Ugh when will it change for the better.
Is anyone down on paper more then 250 grand? Just curious
phosphatidylserine Tuesday, 01/18/11 01:01:42 PM
Re: Threes post# 60267
Post # of 235673
Word about Bavituximab is definitely out. Certainly Gilead Sciences has taken notice.
http://www.google.com/patents?q=bavituximab
I found this old post any interest any puzzle piece
I must say something cause I hardly do. I just hear a loud long drum roll right now with a pleasant large roar. Good luck to all and may peregrine be a force not to be reckoned with.
Just a quick question? Anyone willing to help and chime in. Do we see this stock hitting 2.50 to 3 dollars anytime soon? Something of positive flow to see increases intersest? Thanks
And here's one more catalyst to watch for
"Data from the rectal adenocarcinoma trial will be presented at the American Society for Radiation Oncology's Annual Meeting in October." -- Joseph Shan, VP of Clinical & Regulatory Affairs
But wait, there's more!
Although investors haven't heard much about bavituximab being investigated as a treatment for rectal adenocarcinoma, in October Peregrine should have data to share with the world. In other words, the American Society for Radiation Oncology's annual meeting is most likely the next major catalyst for Peregrine.
Keep in mind that this is an investigator-sponsored trial, so Peregrine has no final say on when the data is going to be released. But for Joseph Shan to go out on a limb and suggest that the company will have data in October demonstrates that the study is likely over or very near completion and the investigator is merely compiling or analyzing the data. Ultimately, we're not talking about a huge indication marketwise, but it would represent yet another successful step forward for bavituximab if successful.
Our contract manufacturing backlog could soar
"Just a little more information on the new facility [for Avid]. It actually more than doubled what our current capacity is in terms of space and bioreactor space that we have over there. So we do have an opportunity here to really to grow the business, even much larger than what our current backlog is." -- Paul Lytle, CFO
Lastly, no discussion of Peregrine would be complete without mentioning the strength of its contract manufacturing business, which is helping to offset some of the rising costs of its late-stage SUNRISE study.
In just a single quarter's time Avid Bioservices' backlog rose form $29 million to $40 million, which in turn allowed Peregrine to suggest guidance of $30 million to $35 million in fiscal 2016. At the midpoint Peregrine is forecasting 22% year-over-year growth for Avid -- and that may be just the beginning.
Avid has a new production facility readying to come online that will support phase 3 and commercial production, and, in the words of CFO Paul Lytle, more than double capacity. Peregrine's management noted on the call that the $11 million increase in backlog had nothing to do with the new facility, implying that Peregrine could really ramp up its backlog and reduce its cash burn in the coming years.
What's an investor to do?
As you can see, there's a lot to be excited about at Peregrine. But this excitement doesn't come without risk.
The vast majority of Peregrine's pipeline revolves around bavituximab and PS-targeting. If SUNRISE misses the mark, then serious doubt will be cast on Peregrine's remaining pipeline, even with the understanding that different cancers can respond differently to the same medication. It's a major risk that investors in this stock have to accept.
Of course, if SUNRISE meets its targets in the interim analysis, it could quickly find a licensing partner at its doorstep, and any future cash concerns would disappear.
Owning Peregrine is a gamble that I believe only extremely high-risk biotech investors should be taking at the moment.
NSCLC is just the beginning
"Our preclinical results study show that the combination treatment with an anti-PD-1 antibody yield superior growth inhibition in a large percentage of subjects, while also exhibiting multiple immunostimulatory changes associated with an anti-immune response as compared to anti-PD-1 alone. Taken together, these results...provide a rationale for the clinical evaluation of bavituximab with PD-1 or PDL-1 targeting drugs in lung cancer and other indications." -- Jeffrey Hutchins, VP of Preclinical Research
While bavituximab as a second-line therapy for NSCLC has the potential to validate bavituximab as a viable therapy and demonstrate the value of Peregrine's drug development platform, NSCLC isn't the end of the line for Peregrine -- it's just the beginning.
Peregrine has presented a number of preclinical studies in recent months that demonstrate bavituximab's PS-blocking activity (binding with PS receptors blocks the immunosuppressant quality of cancer cells) may actually heighten the effect of anti-PD-1 and anti-PD-L1 cancer immunotherapies, which are all the rage among oncology researchers. The PD-1 and PD-L1 drug market is being described on Wall Street as a "tens of billions of dollars" opportunity in the coming decade, and if bavituximab can latch on with these immunotherapies as a combination therapy that improves response rates and survival, it could be a big positive.
You want a catalyst timetable? You got one!
"We plan IDMC interim analysis [for SUNRISE] at 33% and 50% of targeted overall survival events as those are reached, with estimated unblinding of the trial to occur approximately near the calendar year end of 2016. Regarding our planned Phase II second-line non-small cell lung cancer, bavituximab plus nivo [Opdivo], and our planned Phase II, III HER2-negative breast cancer trial, evaluating docetaxel or paclitaxel with bavituximab, we estimate trial initiation for both of those studies during the second half of 2015. And in these open-label studies, we will have the potential for interim data from both studies as early as 2016." -- Steven King
When it comes to clinical-stage biopharmaceutical companies, nothing wets the whistle of investors more than clinical-stage data. Given the success Peregrine has witnessed with its PS-targeting vaccine in preclinical studies, it's moving into a number of midstage and late-stage trials with bavituximab as a combination therapy. These include a second-line NSCLC trial involving Bristol-Myers Squibb 's checkpoint inhibitor Opdivo and a phase 2/3 breast cancer study with either docetaxel or paclitaxel.
While it's impossible to predict the timetable when data might be available, CEO Steven King did his best to offer a tentative timeline for investors during the conference call. An independent data monitoring committee interim analysis for SUNRISE will be conducted for futility at 33% of targeted events, while a second interim analysis will be conducted at 50% of events to examine predictive success or futility. These events are likely to happen before the end of calendar year 2016.
Additionally, interim data for second-line NSCLC with Opdivo and phase 2/3 in breast cancer could be out in early 2016.
Source: Peregrine Pharmaceuticals.
Source: Bristol-Myers Squibb.
5 Things Peregrine Pharmaceuticals Wants You to Know
Source: National Cancer Institute.
Last month small-cap biopharmaceutical company Peregrine Pharmaceuticals , which is focused on developing novel cancer immunotherapy products, reported its fourrth-quarter results, which handily surpassed Wall Street's expectations.
For the fourth quarter, Peregrine announced revenue of $9.3 million, a 44% increase from the year-ago period when it reported $6.5 million in revenue. Although Peregrine's pharmaceutical business is still wholly clinical, its contract manufacturing subsidiary Avid Bioservices has been driving its top-line higher.But higher sales didn't stop Peregrine's year-over-year loss from widening to $13.5 million, or $0.07 per share, from $10.6 million, or $0.06 per share, the year-ago quarter. Nonetheless, Peregrine's revenue came in close to $3 million ahead of estimates, and its loss was $0.01 per share narrower than expected.
On the surface this all sounds great, but these headline figures really give us no idea how healthy Peregrine's pipeline is, or how prepared the company is to survive over the long-term. In order to get those answers we need to turn directly to the horse's mouth, Peregrine's management team, and highlight the five most important takeaways from the company's conference call with investors and analysts.
In no particular order, here's what you need to know (quotes courtesy of S&P Capital IQ ).SUNRISE is on track
"Clinically, our SUNRISE trial in non-small cell lung cancer remains on target to complete patient enrollment by calendar year end." -- Steven King, CEO
Arguably the most important words to come out of Peregrine's conference call came within the first few sentences from CEO Steven King. The SUNRISE trial, which is a phase 3 study examining cancer vaccine bavituximab as a second-line treatment for non-small cell lung cancer, or NSCLC, with a primary endpoint of a statistically significant improvement in overall survival relative to the placebo, remains on track to be fully enrolled by the end of this calendar year.
Aside from the fact that positive data in the SUNRISE study would validate Peregrine's drug development platform targeting phosphatidylserine receptors, remaining on track is important to help keep Peregrine's expenses under control. Despite having contract manufacturing revenue under its belt, Peregrine burned through nearly $43 million in cash in fiscal 2015. It's important its study remains on track so the company doesn't run out of cash.
This is about how I come to conclude to sum it up for me. Do you Thomas take peregrine to be your wedded stock. Do you promise to own it hold it and do not sell it and keep it for better or worse for richer or poor. In clinical trials and beyond and forsaking other stocks be faithful to peregrine till the sunrises. For as long as you both stay alive. I do I do I have. Do you peregrine take Thomas to be your wedded stock holder to finally one day cherish for all he's done. Do you promise to show him to one day support him and comfort him with some good news. To keep him for worse and one day make it better. To only make him poor before he becomes rich. To be faithful to him the way he has to you. To reward his patience and understanding. I do I do I do. Now if no one contest this I consider you both (loud bang) great it's lemmy and he has something to say. Lol. Stay strong stay positive and let the science go to work boys and girls. Have a great weekend. Our day will come. In the meantime pray that those being treated continue to do well. My hopes always. God bless
Toast? I love me some toast... Only thing this toast is gonna be served with caviar. So grab a bottle of wine and you will enjoy it better.
I been re-tweeting for you md. Opened a Twitter account just for this. Go peregrine. God bless and good luck all.
Just to clarify dr rocker I said prediction with hope. Again no numbers. No rumors. A prediction and rumor are not one in the same. Besides one likes to hope for that's what keeps us motivated correct. Expecially when you own 300 thousand shares. Good day to all
No this is the only message board I have ever posted or been on. The others to me are clowns. A lot of investors here post some really valuable information and help she's some light on progress. Not all but the ones who do I truly salute for their time and effort. I am just a stockholder who just decided to share my own opinion. Give a prediction like others do here. However I never mentioned any numbers. Besides the numbers you just layed out there would not make me happy. But once again I feel something is nicely brewing and not just folgers in your cup. Enjoy he morning great day so far in New York. The home of Sloan Kettering. Just saying. Have a good blessed day everyone.
My one and only prediction since owning this stock. Peregrine to be bought out not including avid in deal. Avid is kept and sk stays on to guide the avid ship with increased revenue from its new partner to produce what else but bavituximab. So buyout candidate or partner wanted to make sure production facility was in place and ready for launch. I must say I'm excited and looking forward for bigger news coming soon. I am not talking about news such as ca case dismissed or csm case settled. I'm talking news. Household name news. Blockbuster news. Astronomical news. Good luck guys and girls who stood by peregrine for thick and thin. I feel finally the patience of those will be rewarded and the patients who finally need bavituximab will have access. Patients and patience for better days and better care. Have a good night everyone.
Lemmy what is your targeted share price to sell? Or a share price you feel we should be at? Thanks
So Kenny what current share price would make you happy or proud? Anything wrong asking this question?
Quick question that anyone can please feel free to answer and give me your input. My feeling is the share price right now is solely based on avid. Untill further validation on bavi and collaborations that are ongoing and partnerships that are supposedly at work. Until further pr's one updates and more positive data on trials and possibly stopping sunrise ahead of schedule I believe we are at were we are with the pps once again based on avid alone. So my question is do you feel that avid alone is worth currently 1.40 a share? Is that a fair value for it? I believe so and please anyone drop an input as I would appreciate anyone's insight to how they feel. Good day and luck of the Irish to all.
Lemmy lemmy lemmy you seem to confuse me. Are you invested and a share holder of Pphm? Or just get them kicks of bashing away. If you are a shareholder yes I can see everyone's frustrated but for some reason as bitter as you may seem you stick around so something tells me you believe in something to stay in? You must feel that the days ahead are looking brighter and clearer and the pps will rise. Or if you felt it never would I would think you would sell and move on? Unless your whole purpose is to bash every single thing positive. Does that really help you if you truly are invested in PPHM? I got in at 2 and change and own many many shares and in paper down a ton however I'm not running nor am I bashing. It takes time it takes patience in such investments like this. Hold tight can't you see the positive side at all. The science the new space of oncology treatment. Best wishes
Here is a question since I always see funding and salaries. Why don't managment defer thier payments for a later date along with bonuses to help move bavi? I wouldn't see anything wrong with that idea since he knows he got something astronomical? Just curious.... Hmmmm And yes I do own plenty of shares as of right now that looks like a very poor price by in.
i have great respect for your post and had a question is this true? Or false information ? Expecially the outcome based on missing or censored patients? Cash Crisis and Exaggerated Survival Benefit
By Adam Feuerstein - 09/27/12 - 8:43 AM EDT
Tickers in this article: PPHM
TUSTIN, Calif. (TheStreet) --Peregrine Pharmaceuticals is now dealing with a financial crisis on top of a discredited lung cancer drug.
On Wednesday, Peregrine's lenders filed a notice of default that forced the company to repay immediately a $15 million loan plus interest and fees. "Major discrepancies" in the conduct of Peregrine's bavituximab lung cancer study, disclosed Monday, caused the company to violate the terms of its loan agreement, the creditors said.
Peregrine now has only enough cash on hand to fund operations until April 2013 -- the end of the company's fourth quarter of fiscal year 2013. Peregrine could try to raise more cash via an existing At-The-Market (ATM) equity facility, but such stock sales now are unlikely to due the risk of legal liabilities.
Shares of Peregrine fell 22% to $1.30 in Wednesday after-hours trading. The stock has now lost almost 80% of its value in the past three days.
I was working on the following story about the unreliability of the bavituximab survival data when the company disclosed the study errors Monday. The story is a bit less significant now, but still illustrates the weakness of the Peregrine-bavituximab bull story even if this week's troubles hadn't occured. Peregrine Pharmaceuticals omitted half the patients from the analysis of its bavituximab lung cancer study, thereby exaggerating the drug's reported survival benefit.
The pooled bavituximab arms of the phase II study produced a median overall survival of 12.1 months compared to 5.6 months for the control arm -- a statistically significant benefit, according to Peregrine. But left unsaid by the company is how the unusually large number of patients missing or "censored" from the analysis most likely accounts for the bavituximab survival benefit.
Censoring refers to the practice of excluding patients from an analysis of a study's primary endpoint. In a survival trial, patients are typically censored for two reasons: 1) A patient is lost to follow up i.e. it's not known if he's alive or dead; or 2) A patient is still alive but hasn't been in the study long enough to analyze.
While censoring is a common practice, it does reduce the reliability of study results. Therefore, investigators running clinical trials try to keep the number of censored patients at a minimum by keeping close tabs on all patients and allowing for enough follow up so that the greatest number of patients can be analyzed with sufficient information. Peregrine took none of these precautions. Seventy-nine patients were enrolled in the two bavituximab arms but only 40 patients were accounted for in the survival analysis. That means 39 bavituximab patients, or 49%, were censored and excluded from the analysis. Censored patients show up as "tick marks" on the bavituximab Kaplan-Meier survival curves seen in the slide below. To put Peregrine's 49% patient censoring rate in perspective, six phase III lung cancer studies published recently in the medical literature had an average censoring rate of 19%. On average, each of these studies enrolled 710 patients.
Peregrine's bavituximab study enrolled just 117 patients (including the 38 patients in the control arm) but had more than double the rate of censoring. That speaks to very poor trial conduct.
The amount of patient censoring is important but so is the time at which censoring occurs. In well-conducted clinical trials, more censoring occurs after median overall survival is reached. This typically reflects patients who remain alive in the study when the analysis was conducted. If or when these late-censored patients die, the median overall survival estimate of the trial will not change appreciably. Remember, median is the value in the middle, not the average.
In the Peregrine study, however, much more patient censoring occurred before median overall survival was reached. You can count the tick marks on the survival curves. As a result, the median overall survival estimate is skewed higher artificially. If any of these early-censored patients are found to have died, the median overall survival of pooled bavituximab will not be 12 months but could be significantly lower.
The problem with early censoring can be seen most clearly in the study's 3 mg bavituximab arm, where the median overall survival was reported to be 13 months. However, this analysis was based on 15 deaths, while 18 patients were censored before the median survival was reached. When more patients are missing than confirmed dead in a survival analysis, the estimate is entirely unreliable.
Early censoring can be justified if a trial is relatively immature, meaning patients haven't been followed long enough to analyze.
That's not the case with the Peregrine trial. The bavituximab study was unblinded in December 2011. When the survival data were presented on Sept. 7, the company had 9 months of follow up at a minimum (and this assumes that all patients enrolled on the last day of the trial, which obviously didn't happen.)
Peregrine hasn't disclosed the reasons why patients were censored and the company did not return a phone call seeking comment. But based on previous statements, the bavituximab study was mature enough to avoid early censoring of patients for too-short follow up.
That leaves just one possibility: All the patients censored early in the study before nine months -- and there are lots of them -- were lost to follow up.
--Written by Adam Feuerstein in Boston. >To contact the writer of this article, click here: Adam Feuerstein.
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My question to everyone here is what can we do as stockholders? I know everyone is fumeing and extremely upset and rightfully so. Yelling screaming and pouting out loud. Relieving their frustration out on this board to the point where people are arguing with each other in this board. But again maybe someone knows better cause I am new to investing and completely at a lost with everyone else. Is their anything we can do as share holders????? Can we unite and do anything??? Thank you for any insight or suggestions...
Hello ms my name is Thomas. You may have seen a post or two from me. Please feel free to contact me as this is getting ridiculous and out of hand. My entire life savings is dwindling away and I too would join you should need be. I own over 230 thousand shares. Not happy as you can imagine. Thomas cphtth517@aol.com thank you
Cp,md,pphm,4ourretirment, and any other positive investor I have a free membership and only allowed 3 post. If possible I am asking that you guys would e-mail me at cphtth517@aol.com. I would like and be honored to speak with you guys regarding the stock as I am a young investor heavily into this. I would truly appreciate it. Thank you in advance.
FDA approved ramucirumab (Cyramza Injection, Eli Lilly and Company) for use in combination with docetaxel for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. December 12, 2014. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm426735.htm
Eli lilly drug received fda approval today
i know it sounds frustrating to hear all the time be patient. but i truly believe and have complete faith in the company and its pipeline. its been nerve racking for me also owning over 225 thousand shares at 2.75 but imo this stock will eventually take off once all the good info and data starts flowing.