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Looks like Advaxis is going back to it's original game plan. Most long-term shareholders should remember Tom Moore stating that the plan was to develop constructs and let others take them to trial. Sound familiar? Well, DOC got hired and decided there was too much to lose going that route. But inpatients won the day, (and please FBG, don't remind us yet again of the 40% value destruction and share grab, etc, etc.) and tutes apparently want something sooner than later. So, back to square one, at least how I see it. Remember Advaxis has around 15 patented constructs ready for licensing..
This is so interesting:
"I knew what you meant" - that my prediction for the value of Advaxis was based on positive outcome data. Not only a reasonable requirement but a necessary one.
But you then go on to confuse that my prediction, which is what Advaxis would be worth IF data were positive, with the assumption that I actually predicted positive, even stellar, outcome data, which of course I did not.
This post says a lot about you FBG, an awful lot.
Actually, I think I said 10B. The implied condition, of course, was if it worked and if it became standard of care. I think everyone on the board knew what I meant when I said it. Why didn't you?
There been a lot of spin from some on the board about the HER2 decision. Quote:
"ADXS-HER2 was evaluated in a Phase 1b clinical trial in patients with metastatic HER2 expressing solid tumors. The Company has evaluated the data, and based on the Company’s priorities, has determined not to pursue further clinical study of ADXS-HER2 at this time but remains open to investigator-initiated research or licensing proposals."
I can't see how anyone can spin this. They looked at the data and killed the trial. It's a reach of incredible length to say the trial didn't fail and the the company is just focusing on it's other products. IMO, this is the first failed trial for Advaxis, but certainly doesn't mean the other constructs are in trouble. The data for each construct will be evaluated individually. They continually look at the data from all the trials and are responsibly proceeding with those that work.
This seems to indicate a degree of manipulation to me, but can someone more able than me take a look at these numbers and tell us what they may indicate?
Date Close High Low Volume Short Volume % of Vol Shorted
Sep 07 NA NA NA 224,005 115,091 51.38%
Sep 06 NA NA NA 115,391 56,202 48.71%
Sep 05 NA NA NA 73,007 36,984 50.66%
Sep 01 NA NA NA 61,441 24,256 39.48%
Aug 31 NA NA NA 115,743 45,946 39.70%
Aug 30 NA NA NA 170,575 82,771 48.52%
Aug 29 NA NA NA 142,159 74,196 52.19%
Aug 28 NA NA NA 106,732 48,633 45.57%
Aug 25 NA NA NA 76,060 40,251 52.92%
Aug 24 NA NA NA 126,822 51,239 40.40%
Aug 23 NA NA NA 80,832 34,083 42.17%
Aug 22 NA NA NA 116,039 70,718 60.94%
Aug 21 NA NA NA 160,495 79,045 49.25%
Aug 18 NA NA NA 106,117 54,949 51.78%
Aug 17 NA NA NA 65,673 35,145 53.52%
Aug 16 NA NA NA 50,335 26,133 51.92%
Aug 15 NA NA NA 67,242 31,413 46.72%
Aug 14 NA NA NA 110,676 62,403 56.38%
Aug 11 NA NA NA 116,298 79,289 68.18%
Aug 10 NA NA NA 142,115 78,364 55.14%
Aug 09 NA NA NA 120,008 66,394 55.32%
I'm ambivalent to what you'd be happy with. We each hope for the best. But honest discussions require honest appraisal when talking about the true value of our holding. While true that there had been the 40% value destruction under DOC's watch, it's also true that he wasn't entirely in control of that destruction, was he? To say otherwise would be to ignore the 10 million short shares. Sure, he COULD have made a deal like Aduro did, but he chose a different path. (And also remember that Aduro lost what, 70% of it's value from it's IPO?) One, btw, the BOD knew about and approved of I'm sure. So over time sentiment changed and even, we think, the bigger investors wanted a roi sooner rather than later. So here we are with everyone now thinking we're in discussions for a buy out or partnership. Is that the best path? Or to ask the question slightly differently..Is that the best long-term path?? Again, we need an honest discussion of what Advaxis will be worth if it becomes the SOC in multiple cancers. One reason I believe this is entirely possible is based on not only the effectiveness proved to date but also the cost of treatment. Advaxis can charge what it wants, the CAR-T treatments will bankrupt people.
I see plenty of people wishing for a bo so they can move on. But whenever I or anyone else asks these people for an honest appraisal of our true value if the science works across all platforms things become relatively quiet.
Let's start with just one thing...What is Advaxis worth if HER2 works in breast cancer and adds, say 5 years on average above current soc?
How many people get breast cancer?
How soon do they die?
How old are they, on average, when they are first diagnosed?
How costly is current treatment?
How many years does current treatment add to the lives of those afflicted?
How much will Advaxis charge per treatment cycle?
Will insurance pay for this treatment?
What is it worth in non-US markets?
Etc, etc....
Then, crunch some numbers.....
Remember, we've NEVER had a failed trial. Early on we had one or two very poorly designed ones that never completed, but those days are behind us. I believe the question is not why do I think it's worth so much, but why I or anyone else doesn't think it's worth more.
You say other companies can bring this to market faster than current management. Why do you believe this? Clinical trials run at pretty much a pre-determined speed based on anticipated enrollment and number of trial sites. You've never mentioned either of these factors and as I recall the number of trial sites involved in at least some of our trials only go up over time. But again, I haven't heard you complain of this.
I could go on, but in the end I fear you and I will just have to agree to disagree.
But let me ask you just one more question and please be honest. Will you sell if it hits $25 with just a partnership or will you hang on for more?
This is so interesting. You speculate a licensing deal for ONE construct sets our value at 800m, but the sale of the entire company, which includes HOT, NEO, DUAL, plus all of our patents, is only 200=400m more.
So you're not giving much value to anything, including psa (prostate) and her2 (breast) which are by FAR much bigger markets than AXAL will ever be.
Lets not forget that HER2 is the same antigen about to be approved in canine and is testing in pediatric osteo, so, proof of concept in that one also.
May I ask why you believe this?
It's my belief that HER2 ALONE will value this company at over 10B.
I understand the frustration, I've been in this stock since 2010, about as long as you. I'm not going to give up the race, or wish it to be over, with the finish line in sight.
I've said it before, and now's as good a time as any to repeat it. One VERY important factor that makes Advaxis different is the cost to manufacture - less then $10 a dose. While the new CAR-T treatment will cost upwards of a half-million dollars to the consumer, Advaxis can charge almost almost anything and still make a nice profit. Insurance companies will balk at the high cost of most of these new treatments while Advaxis can set a price point to avoid most of the controversy. Also, these other companies will have very limited access into poorer countries, Advaxis will have no problem going to these places and helping people the world over.
Ask yourself - how will a society afford a cancer treatment that costs a half million dollars?? The first one approved is for kids, so yeah, insurance, second mortgages, fund raisers, gofundme drives, etc. But extend this to prostate or breast cancer. Will a 50-something choose to bankrupt their family for a few more years?? Make no mistake, that's the question some families will face. I can see a time when insurance companies will say "try the vaccine first, if it doesn't work we'll talk".
Interesting ethical dilemmas ahead....
Miesh - Sorry, but I most certainly DID consider the delays. The EU must, lets put that in capitals, shall we? MUST respond within 6 months. Anticipated delays come in the form of 2 "time outs" that can be up to 3 months each. So max time is 1 year. Your insistence on this point is a bit baffling. Do you have any other reason to believe what you state other than "the likelihood of delays" ??
Also, you haven't answered my very nicely worded question about the run up between submission and the delivery of an answer.
I did some research and analysis a while back trying to determine when approval may occur.
In summary -
Advaxis submits for approval sometime in 4qtr.
EU has 6 months to respond - clock starts on submission
There can be up to 2 "time outs" - used for company to respond to questions - of up to 3 months each.
Therefor the latest we know is end of 2018.
If Advaxis has the submission in pristine form, submits closer to the beginning the 4th qtr, doesn't need to use any time outs AND the science is acceptable - we can be looking at EU approval as early at mid 2018, less than a year away.
Personally I give a 70% chance it'll about a year from now.
So I can't agree with your mid 2019 suggestion. But, what do you think will happen UPON submission?? This will occur THIS year, and my experience with DNDN tells me the run up will occur well before the EU even responds.
This is a serious question to you as I (and most of the message board) value your insights.
Samk - While I look forward to these results, I'm somewhat disappointed that the only reveal we'll have is the vaccine arm of the study, not the combo results. While I don't think the company will put out bad news on this arm, it's the combo results I'm really interested it. All reading this board should have some realistic expectations about how the market may react to this news. My experience with these type of events for Advaxis tells me the street may just yawn, thought I'm hoping otherwise.
Interesting observation - Did you see if they had a partner in place for distribution in the EU?
James - did he mention attenuated bacteria??
This is easy to reconcile:
"Dan, we appreciate what you've done for the company since you've signed on, but you know as well as we do that your vision for the future is different than ours. We're going to begin a search for another CEO and we're asking your for your resignation. It would be in your best interest and well as ours"
There you go...blindsided AND Advaxis gets to say Dan resigned of his own accord. Politics 101.
Aduro's deal with JnJ was preclinical also
Hey blue. I like the thought of EU approval before a partnership, but I wonder if approval requires a distribution plan. Do you know if it does or doesn't?
I'm fairly certain in the U.S. it does.
I try to keep reminding myself that nothing has changed in the science and we have nothing but good news on that front.
But I've also been thru the DNDN debacle and obviously don't want history to repeat itself with Advaxis. For the record, I don't think it will, but the BOD really does need to name a permanent CEO and get a deal done.
I was thinking the same thing. Dan resigned July 6th, the pps then was around 6.35.
It's time the BOD either gives us a new CEO or names Lomardo the permanent CEO. I don't think we'll get many new investors with a captain-less ship.
Is this tweet from Advaxis foretelling good news is imminent?
Tweeted yesterday:
"Proud to be presenting data from our PSA and HPV programs at @AACR 2017 Int'l #Immunotherapy Conference"
I guess we can speculate exactly what they're proud of:
- proud of the conference itself?
- proud to be among their peers in the immunotherapy field?
OR!!
- Pround of their data?
Considering the silence from Advaxis of late, I think this is a real possibility. If they are proud of their DATA, it could be a real turning point upon it's presentation.
One things for sure, I'll be watching that conference closely.
What does everyone think?
The answer would be in the corporate presentation. OR, you can go to clinicaltrials.gov and look up the trial in question and look for yourself when the reporting date is.
This is simply wrong. Provide evidence to back up this claim. You can't because it doesn't exist. Trials are designed, negotiations take place with member sites, protocols implemented, patients recruited, dosed, and monitored, data collected and analyzed, and finally presented. These things take TIME. One trial does not move faster simply because other trials are not undertaken.
So out of these 10 bullet points, only 1 1/2 can be considered in the realm of getting Advaxis ready to sell
- acquired and aggregated companies
- consolidated businesses
The rest read as management type services at a very high level. Seems to me to be a bit of a stretch to say that Channel was brought in to sell Advaxis off. I recommend a bit collective breath....
Mcaero - Good to hear from you! Unfortunate that my post got deleted for being "off topic" - I think one of the mods here lets the power go to their head. Anyway, there have been plenty of times where I really wished I had your perspective. As far as the RS, sure value went down, but it was what got us on the the NASDAQ, which needed to happen.
So I do have one burning question for you: Since you think the board wants to sell the company, what do YOU believe is fair value? As you've been lurking you know it's a subject of much debate with values ranging from 1-8 billion or more. Also, do you think the board should wait until after this fall, with all that's on the table (EU submission, possible partnership, trial results) for greater value?
For anyone reading this who doesn't know mcareo - he was one of the most influential posters back in 2010-12 on the yahoo message board. (I believe he went by mcareoinv back then.) He's a CEO (still I hope!) with great insight into the inner workings of companies. All would do well to listen to everything he has to say.
For the record Tin, when I read your first post it kinda made sense and appealed to the conspiracy theorist in me. And like you I was a bit surprised by the backlash from people who've been shouting "Manipulation!" for YEARS.
I also thought at the time and still believe now, that IF this is the case there is no way they're gonna drag us down to $5. That's too low and there are too many funds and tutes who aren't involved that would scream bloody murder to the SEC.
There is also a time factor involved now. Combo trial results are out in a matter of months, if not weeks. Good news on this front will cause more tute buying. Also, an EU partnership deal may be announced at any time. Later this year, EU approval application will be announced. Then there are the unknown unknowns which aren't predictable. Can shorts take that pain? Can they walk it down yet again? Will they take that chance??
One other thing - IF this was set up in advance, DOC would have been involved and he is gone now. This kinds of unlawfulness is highly unlikely to have many people involved in it. Those that are left at Advaxis are unlikely to have the power to pull it off, unless of course it was the BOD itself. Lombardo, as I recall, was only recently brought on, so wouldn't have been involved in the first place, and would be under no obligation, IF all this is TRUE and they TOLD him about it, to continue. But, he plays the game and may have reasons I can't even imagine to let the shorts have their way.
So my thought now is this - IF your theory is true, the shelf offering will be soon, within the next month or six weeks, and occur at a share price near where it is now. If not, the shorts are going to get burned in a big way when good news comes out.
One last thing - It really doesn't matter to me either way. Sure, I know that dilution decreases my profit by x%, followed by a staggering share price, but at the end of the day the brakes will have been released, the pressure off, and the sp and market cap WILL rise. Advaxis will now get the credit it deserves on wall street and the media. Think of this headline: "Advaxis short interest decreases by 90%". Would raise some eyebrows I think.
Anyway, and as always - GLTAL's!!
That wasn't the question. IF a stellar CEO was hired, what would your thoughts be?
Let me ask you guys a question. Let's say Lombardo is truly interim and they're looking for a new CEO. Now let's say they hire someone of truly spectacular caliber. Would you think Advaxis would be going for a moonshot if this occurred, i.e. going it alone, to be the next Amgen, Celgene, etc?
Hey equal - Perhaps Advaxis finally learned the lesson that every time good news is issued the sp drops and are staying quiet with the thought "ok shorts, just try to drop it on this news...."
This is incorrect on a few levels. First, there could, and indeed many think there will be, a bp deal soon. There may be a buyout. (I hope not)
But mostly, raj, we have SPA. If the results of the PIII are good, as we all hope and expect, the sp will climb very quickly on the news, which will be well before Advaxis even submits that data to the FDA. SPA is the FDA's nod of approval to the trial design and data analysis, so good data=approval.
When I was in DNDN, the sp just before approval was around 85% of it's all time high, which occurred about a week or so after approval, and just before some insiders sold some shares.
I couldn't help but think the same thin zz...that magic pps numbers aren't really that important. If that were the case why the heck did we ever drop from 30? Many factors are in play here, and being the conspiracy theorist that I am I don't eliminate the possibility that some, ie., those with lots to lose, may think that advaxis is disruptive technology and act accordingly. Suppress it if you can, buy it if you must. Combo data out this fall....if good it'll be too difficult to suppress it then. That'll only leave them one choice. But personally I hope Advaxis doesn't get bought out.
Batermere, you wrote:
"You mentioned the high failure rate of small cap Biotechs with market caps under $300 million that have a product in FDA Phase 3. I believe your numbers are correct."
This is incorrect. The overall failure rate for any product in a PIII is around 30%. This means a 70% SUCCESS rate. Think about it. What sane company is going to go thru the expense of a PIII, or collaborate in one for that matter, if there are not very strong signals it will succeed. I've posted this before, and am really not inclined to redo my references, so you or anyone can go do a simple search of the FDA website.
Thanks iggy. I should have stated more clearly my underlying assuption is that all goes well with all trials.. Even FBG admits this is likely based on trial results thus far, both human and animal. I get the risk concept, but could you explain discounting to net present value, which I assume is just cash on hand plus assests? What else is included in this number?
FBG - I'll ask ahead of time that as you read this post you consider very carefully what I ask of you and respond accordingly. You're obviously fairly bright and are capable of doing the analysis I ask of you, which is this:
You state Advaxis would do well if sold for a 1B valuation, or around $25 a share because of all the damage DOC has done over the last four years. You believe everyone, or at least the institutional investors would go home happy if they did so. While that may be true, or not, I believe you're leaving something very important out. So please run the math and tell us
1 - What are the constructs worth (i.e. how much revenue will they generate yearly after approval) at say $70K per treatment cycle with say a 50% market penetration? Please include cervical, prostate, breast, pediatric osteo, anal, and head and neck cancers, as these are the ones in clinical development. (The 70K figure is not made up, but something I figured out years ago based on some things DOC said. The 50% market penetration is my figure. Feel free to modify this as you wish). This number will represent the value of Advaxis in the near future, less than 7 years I'd say.
2 - Extend this figure into not just the US market, but the world market. You can reduce the cost per treatment cycle in non-US markets as you see fit.
3-The cost to manufacture has been determined to be less than $10 a dose, go ahead and subtract that out if you feel you must, but it's so minimal I wouldn't bother if I were you. But go ahead and add in any other overhead you'd like.
4- Let us know how much a company generating this revenue is worth on the stock exchange. I'm admittedly not knowledgeable about this so let me know.
For arguments sake, I'll say 15-20B. Next, please let us know, as you contend..
5 - How DOC caused 14-19 billion (or whatever number you come up with) in value destruction based on how bad he ran Advaxis over the last four years. Exactly what deals did he make that are going to erase this much revenue? What are your assumptions and what is your math?
You may think I'm being argumentative, but you'd be incorrect. You do know I disagree with you, but I really am asking for a justification for your position. If you're going to be posting your position repeatedly you should answer these questions to the best of your ability. Then we can move the conversation forward based on more solid analysis.
Lombardo has been appointed as interim CEO. If he was intended to be a permanent replacement I think that would have stated that already. From what I read of his bio I wasn't too impressed, some experience in much smaller companies than what Advaxis will eventually become. I'd prefer to see a new appointment with a top level exec from say BMY, with whom we have ties with already.
You expect the sp to rise next week. Why do you think it didn't start yesterday?
There's no reason not to believe those that say the institutions put pressure on the BOD and forced DOC out. Money does talk after all and it makes perfect sense. Carry this logic forward, however, into the idea that they actually want Advaxis to be bought out and it begins to break down.
It's been said by those much more experienced than I that a buyout would be no more than a 50-75% premium. For arguments sake let's say 100%, or double the mc. Currently they would have to pay less than 600m. At a real mc of 1.5B or 5x where we are now, the sp would still be less than $40, and they would pay 3B or a sp of around $75.
Adage bought twice, the second time at 19. The run up a few years ago was swift, we were in the teens in a matter of months, so that's where many of the other tutes bought in also.
A question for all those who believe Advaxis will accept a "reasonable" buyout offer - Will big money institutions be satisfied with a 4 to 6 bagger when, if they wait a bit longer, they'll get a 10 or 20 bagger?
-It's also been said by some very smart people on the board that the tutes work on different time lines than retail investors. If true, it's an argument the tutes will want Advaxis to remain independent.
-Advaxis is a platform technology that's already demonstrated effectiveness across multiple antigens. Since the number of antigens is virtually unlimited, so is the potential of this company. Tutes know this - another argument they'll want to remain independent.
- Advaxis has said in the past (albeit by TM) that the business plan is to license constructs as they're developed. Evidence that Advaxis themselves want to remain independent. (Does anyone remember DOC saying this? I can't recall)
No one on this board has a crystal ball. The best we can do is weigh the evidence and make our best assumptions based on the facts and our understanding of individual and institutional motivation. Yes, I believe the tutes forced DOC out and yes, I believe they still want Advaxis to remain independent. I expect a licensing deal soon, not a buy out. At the same time I respect others opinions and welcome the arguments.
GLTAL's!!
Blue - Lombardo was specifically named as interim CEO. I suppose the possibility exists that he'll be made permanent, but I can't help wondering if this was all set up in advance why give him the title of interim CEO? Sounds like the board is sending a message that someone else will be taking over. What do you think?
Point taken fbg, and I reluctantly agree. (Though I do appreciate what DO has done more than you)
Let me ask you something in all seriousness- Lombardo was brought on about 6 months ago. Could it be DO knew the writing was on the wall then, and his actions (or lack thereof) since reflected the fact he knew he was on the way out?
The numbers I chose were from other posts. I was trying to exemplify the point you stated - the longer we wait the more we're worth. Exact numbers are pure speculation at this point.
Interesting development. I like the way the board came alive with speculation as to why this happened and what it means going forward. Consensus seems to be this is a good thing and there is indeed historical evidence for it. When Tom Moore got the boot the sp jumped. Not too long after Adage signed on and six months after that we were a 30 and were building the coffers. Fast forward to now with 4 products in trials, one in a PIII, and BP deals for neo and hot. Hard to say DO wasn't busy.
But let me ask everyone - Is a buy out really what you want right now? Being this close to an approval and revenue I'd say no way. There are still a handful of us true ultra longs around, probably more that aren't posting, and we've been insanely patient because we fully believe in the science and have done our dd on what it could ultimately do to the market cap. I think 10-20 billion is conservative in the 5 year or less time frame. More, perhaps much more, further out. Heck, prostate alone could be worth 10B. So why are so many willing to settle for 2.5B? And is that even reachable in 6 month time frame some are talking about? There'd have to be a short squeeze of epic proportions for that to occur. Don't get me wrong, it could happen, milestones are upcoming and hopefully all will be good. But still....2.5B now or 10B in 4 years? Let me leave you with this thought. If, or when really, we get to 2.5B, then 10B is inevitable.
Thanks for posting James. When I see these posts I try to think about how much training/lead time is needed before the job goes full steam. For something like quality control lead, I can't imagine it's more than 6 months. I believe the director of QC was hired some time ago. It's apparent Advaxis is hiring staffers now in anticipation of full scale manufacturing.
GLTAL's!!