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Thanks investorluck, I missed those data. Encouraging, for sure, although numbers are very small (12).
CATTDOG12347, point me to where you see that 3-dose 2X SOC for 12 month OS. I can't find that group broken out.
Point taken that 0265 participants were sicker than average SOC patients, suggesting AXAL should show better against a randomized control arm....but, that's somewhat the point: there's no way to know for certain ahead of the AIM2Cerv interim results in 2019. I don't believe any other Ph2 with randomized control arm will have results before then(?).
I expect we'll have various pieces of good news between now and then: EU approval (conditional on ongoing results better than SOC and AIM2Cerv results), various Ph1 and Ph2 trials with positive outcomes. New developments not on the radar. Let's hope all those things happen.
But, ultimately, much of what ADXS is doing may not matter if we don't get good AIM2Cerv results. If AIM2Cerv fails, whatever value those other achievements offer could evaporate overnight. Neoepitopes could still work even if AXAL does not, so AXAL may not be the whole ball of wax for ADXS.
Lots of moving parts that we need to dig into to construct a usable "if/ then" set of scenarios so we can judge the significance of both positive and negative events as they occur.
Good points, huskercatman123. We do not know the fine print T&C's of the Amgen deal, so don't know to what extent AXAL is tied up with the neoantigen technology. Maybe it was revealed in the 10K, but I'm not even sure we signed over any right to AXAL, only to the neoantigen technology -- others who have read/ remember the 10K better please chime in here.
Your point is right on though: to what extent are potential partnerships narrowed due to the Amgen deal?
Easymneyman00, you say, "...SOC now has pretty much got doubled by our vaccine. Not to mention the fact our safety and efficacy and manufacturing costs are minimal compared to SOC!"
I agree on safety and manufacturing costs being superior, but I don't know where you get "SOC got doubled." Nothing of the sort. Our 12 month OS was 38%, SOC is 30% 12 month OS. That's not anywhere near double. And, keep in mind SOC was not a randomized control arm. Strange "stuff" happens when you do a randomized control arm as we are with AIM2Cerv.
I believe we have a therapy that will work, but overselling the data and lack of risk is a disservice to those who do not dig into or understand the data in detail.
Maybe I do sound too pessimistic to some. My approach to investing is to take a conservative view on what a company may accomplish in a given time period and use that as my benchmark for judging whether the risk/ return is right. With ADXS I am assuming the science will work -- and that's a big assumption/ risk even though the data look good so far -- and I am assuming timing will not slip noticeably from projections...another big assumption with risk. We've seen things slip (e.g., Aratana). EU approval could slip. Trial progress could slip.
The unknowns I think we may have different views on is how market cap will react to events/ timing and the likelihood of some big, unpredictable positive surprise. If ADXS were mainstream, I'd be more optimistic about earlier, bigger price appreciation based on events/ timing. I never factor in that "something big" could happen we're not aware of. Amgen was an unexpected "big deal," as an example of such, but got no sustained pps gain. It was an excellent trading opportunity.
Don't get me wrong, I think ADXS could be a big winner. I just think expectations for significant sustained pps gains in the near future (6-12 months) are unrealistic. Happy to be proven wrong!
kyndiloh1...yes, that's what we are all hoping will happen, but science, competition, execution, bureaucracies...they all conspire against the best outcome. But, I'm invested here even if the "best outcome" does not happen. I expect to be happy with my return (a little less so with the time factor...I am not young!) if the "acceptable outcome" occurs (full monetization after Ph3).
Thanks Peke, I agree. All the signs are positive. Let's hope they stay that way. Time is of the essence, but it goes so slowly....
Biotech investing probabilities/ risk...
I'm not saying the following is 100% accurate, it certainly is not, but it provides some general sense for the risks/ reward requirements in biotech investing. ADXS is past Ph2, so we are in a much better position on a pure probabilistic basis than many biotech companies, but still only 50/50 according to this general analysis...
From Biotech board by Biovest2K
http://www.investorvillage.com/smbd.asp?mb=58&mn=2546&pt=msg&mid=17066898
May the odds be forever in your favor
Here is some math to demonstrate why waiting pays in spec biotechs.
1. Roughly 5 out of 100 companies that do clinical research end up taking a drug from pre clinic to market. If you picked 100 companies and put $10 in each, you would spend $1,000 on the investment. So 95 of them would fail and you would lose $950. That means the 5 that succeed would have to go to $200. That would need to be a 1900% return on all 5 that succeed for you to just break even. That is a massive return you would need to shoot for.
2. If you wait till after just 1 successful clinical trial like a Phase 1, the odd go from 5% to 20% for success. I usually don't put a lot of faith in phase 1 trials since they are mostly designed just to see if the drug is safe for humans. They do some basic efficacy measurements, but they tend to be very off the mark since everyone in the trial is taking different doses. Even so, you would put $10 into 100 of these companies. 80 of them would fail and you would lose $800. The remaining 20 that succeed would have to go to $50. They would all have to go up 400% for you to break even. That is far better odds then example 1.
3. If you wait until you get good phase 2 data, then the odd go to over 50% for success. Let us assume you put $10 in each of these companies for 100 companies. You would have a $500 loss from the 50 that fail. That means the remaining 50 would have to double for you to break even. Now the odds are much more in your favor. Any good company that makes it to market should double at least. That obviously depend on the size of the drugs market. Most of them should go up at least a few hundred percent over the long term and even more if one success leads to more.
Polaco3us, I did look at the table with both dose cohorts. A sample 3 three patients for the 2-dose cohort is too small to be very confident in the better response than the 1-dose cohort. I do believe ADXS has something there with AXAL, but no one should be convinced AXAL will blow the doors off a randomized SOC control arm. I hope it does -- I'm invested on that belief -- but I'm just trying to caution anyone who thinks AXAL is a slam-dunk. It's not.
Ignatius, yes, accelerated approval is always possible -- and I hope we get it! But, a prudent investor would not be betting on that or disappointed if it does not happen.
Consider, EU approval is not likely before 1Q2018, IMHO. We have not yet filed for it and once we do there's at least a 150-225 day cycle, and it's not even clear how that works...things always take longer than expected. I'm not sure when an interim look at AIM2Cerv might occur, but unlikely before 3Q/4Q2018? Accelerated approval, if it followed, might take another 6-12 months, so we're looking at mid-2019. That's a year earlier than AIM2Cerv is scheduled to end, so that would be good...but that's the 2 years (or 3 years) from now I was referring to.
And to your point about appreciation over the next 2-3 years, yes, I would expect there would some be on news of other trials, the neoantigen work, and other things. It might be as much as 2X-3X current pps. But, getting to that 5X-10X-20X (the latter being the much-bandied ~$6B valuation) pps advance...that will take the near-certainty of AXAL approval, which I think is still 2-3 years...and a lot of risk...away.
tx_farmer, ADXS is legit alright. That's why I own a chunk.
But, FIRST: anyone investing here MUST be ready to lose much of what they invest. That's the nature of biotech -- if our AIM2Cerv fails and neoepitopes prove not as powerful as expected....
SECOND, anyone investing in ADXS now must be willing to wait at least 2-3 years before they might be able to harvest a sizable return. For those with the appropriate investing acumen, a worthwhile strategy for biotechs, including ADXS, is to buy dips and sell into rapid price increases like Aug/Sep 2013 (~$2.50=>~$6.00), Dec/Jan 2015 (~$3.50=>~$12.00), Feb/Jun 2015 (~$7.50=>$28.00), and Jul/Aug 2016 (~$8.00=>~$15.00). Of course, it's always easy in hindsight to pick the right points to buy and the right points to sell on these up and down moves. But, any up move not predicated on the expectation of an excellent Ph3 outcome is likely to be sold off in time. ADXS might still test its Feb 2016 lows (~$5.50) before moving higher, but now might be a good price point to be buying, although keeping dry powder for moves lower.
Thanks again for finding/ posting that presentation by Dan and related parties -- it is very informative.
Ph2 GOG-0265...just as a reminder, this study showed good, if not overwhelmingly good, results (38% 12 month OS vs 30% for SOC; p <0.02).
The sample size was fairly small so the findings are not overwhelmingly positive (38% vs 30%) or robust (<0.02 on N=50). Keep in mind, this was not a 2-arm randomized study (typically required for Ph3). Therefore, I think an accelerated FDA approval application for AXAL is not likely and the company has not said it will do that as far as I know.
The registrational study for AXAL will be AIM2Cerv, which is beginning now, but will not have a read-out until 2020 (per company statement). Therefore, FDA approval would not come until until after that point.
http://www.advaxis.com/wp-content/uploads/2017/03/Advaxis_SGO2017.pdf
While I'm hopeful of EU marketing approval, it could be early/ mid-2018 before that occurs, with revenue not to be expected sooner than ~12 months after approval (~2019).
DOC is pushing hard and fast on all fronts, so delays due to mismanagement are unlikely, there are other parties that ADXS must rely on for approval and marketing that may not have the same break-neck urgency.
Other combination trials are in progress but are Ph1/2 and not likely to lead to FDA approval before the above. ADXS's exciting neoantigen work with Amgen looks very encouraging, but it also is in very early days.
Anyone expecting ADXS to vault to a $6B valuation anytime soon (e.g., 1-2 years) is fooling themselves, IMHO. Could ADXS get bought out in the next 1-2 years at a very nice multiple of its current value (e.g.,10X; $3B; $50-$75/sh)? Sure, could happen.
I'm as serious about my investment in ADXS as anyone on this board, but the rampant "why doesn't ADXS get FDA approve AXAL now" talk is naive and unrealistic, and the "Dan is messing up our investment" talk is just as misguided. Both are not well-considered judgments, IMHO.
Take time to absorb what this excellent presentation by DOC posted by txfarmer provides:
www.youtube.com/watch?v=_1uS6V5WtO4
ADXS is making EXCELLENT progress -- it's just a slow slog to a much higher valuation. Pay attention to the fundamentals, buy dips (as we have had recently), watch out for any data that suggests Lm is not as robust as we believe (although the Amgen partnership dispels much of that concern for the time being), and, finally, be patient, hard as that is. I understand those who invested in 2013 or before are frustrated, but it's the future you need to evaluate, not the past.
Ph1 dose escalation study. While a small study, and one designed to test dose escalation tolerance, not disease impact, one might have wished to see more disease impact:
http://www.advaxis.com/wp-content/uploads/2015/11/High-dose-treatment-with-ADXS11-001.pdf
Any more versed in the science and trial designed might comment on the above.
fbg0316, it certainly sounds like DOC was overly optimistic about the likely timeline for ADXS to get to a $6B valuation (before my time -- I got into ADXS early in 2015). It is unfortunate that an investor would rely on such a statement as even then a reasonable understanding of immunotherapy time-lines would lead one to look askance at such a prediction knowing ADXS's history (weak) and technology (promising, but unproven and out-of-the-mainstream).
Be that as it may, it is surely naive at this time to use that assertion by DOC as some indicator than ADXS is not being managed effectively. It judging progress by ADXS, one not only needs to take into account the science challenges and FDA hurdles, one must consider the investing landscape has changed dramatically since 2013. 2013-2015 was a huge biotech bubble where valuations got way out of line. Even ADXS spiked to ~$30/ sh. That bubble has burst with the typical overshoot to the downside.
If you were investing in internet stocks between 1995 and 2001 (I was), you know what I'm talking about. Then, it took at least 5 years after 2001 for that market to sort itself out and for real winners to become valued in line with reasonable expectations. The same thing is happening in biotech at this moment. We are in the equivalent of 2003 of the internet bubble sort-out, which means we may have 2-3 more years to go on that score. It will take short money quite a while yet to leave this sector for more fertile grounds.
Next, the competitive landscape has gotten much, much more crowded than it was in 2013. Any biotech in immunotherapy is absolutely subjected to much more critical evaluation as to its prospects. As I've pointed out, ADXS is way out of the mainstream in terms of its science, thus does not get the kind of attention that can help drive pps. Dan's compensation, even if it were egregious, has NOTHING to do with pps. Raising capital at good prices well ahead of when it is needed is a POSITIVE, not a negative. Reasonable dilution (which is what we've had) is to be EXPECTED and embraced, not railed against.
I think ADXS could be a huge winner, that's why I'm heavily invested in it. But, let's focus on what really matters to our judgment as to whether this company is worth staying invested in. We should be focusing on what trials ADXS is considering (choice here is critical), whether ADXS meets timelines for trial starts/ information results releases, how it continues to acquire funding, and what partnerships it develops with what terms and conditions. And, of course, we should be making thoughtful judgments about the quality of trial results: are they really strong or just purported to be strong? Careful of spin here, every company spins its results except those that are clearly thumbs down.
Those last 3 sentences are where people on this board should be putting their DD time and effort and with regard to which they should be sharing their thinking. When you do that, and you do, you're adding value to the discussion. When you carp about Dan's compensation and capital raises you are missing the mark, IMHO. Let's move on!
tx_farmer, thanks for that presentation material. VERY informative, everyone should listen to it.
For anyone doubting ADXS needs as much funding as it can acquire (at good prices) consider how many clinical trials they are running -- and only a few are Ph3 that could lead to an FDA approval. Others are Ph2 (or Ph1), so it will be years before approval. AIM2Cerv, the Ph3 trial that will hopefully result in FDA marketing approval for ADXS cervical Lm therapy will not conclude until 2020.
ADXS will need more funding before we realize the ultimate value of our investment. Not be be feared, just to be understood.
fbg0316, first of all: apology accepted. My explanation may sound like the consultant's report because, while exec comp has not been my specific field of expertise, I am quite familiar with it, both as a consultant, as CEO of a PE-backed $200M company I ran, and as someone who lived in Silicon Valley for 20+ years and had numerous VC and start-up CEO friends. So, I understand exec comp in high-risk, pre-revenue companies. And, I did, as you know, spend considerable time going through ADXS 10Ks to understand the specific details of DOC's compensation, so I wasn't just "winging it." And, no, I was not involved in any way with the consultant's report to ADXS. That's not the kind of consulting I do.
If you think DOC and other execs are being richly rewarded... you can't imagine what it takes to get first class talent...."sign on" bonuses of $1M are not uncommon because people are often walking away from options worth that and more to go to a new firm. And, keep in mind, while RSUs might have a value of $1M at date of grant, they only retain that value if the exec team delivers value for shareholders (and themselves), and they often can't be sold for ~3 years.
I agree it is absolutely fair to raise questions about exec comp, but you have to investigate several things in order to make judgments: typical exec comp standards and practices, the requirements of the type of business within which the comp plan exists, the quality of the people being hired and paid/ incented, etc. I was simply trying to give you and the board the benefit of my experience and expertise.
One last point on DOC's compensation. You have claimed he was dishonest in the way he got some members of the BOD to be replaced after his first compensation plan was rejected in 2014. I provided what I think is an even more plausible explanation in a previous email I will summarize here. Dan had clearly and specifically saved the company from bankruptcy. The BOD had appointed him CEO with the explicit promise he would be rewarded if he did so. After he did they balked at following through -- or at least to the dollar amount Dan thought appropriate. Dan went to the major shareholders (not publicly) and said, "Fix the BOD, get me paid appropriately, and I'll stay. Fail to do that and I'm gone." There's nothing dishonest or underhanded about that. It happens all the time. Execs say to BODs/ shareholders, "I'm worth more, pay me more." Sometimes they get what they want, sometimes not.
IMHO, Dan is WELL WORTH every penny he's paid in salary and options (he has only been given ONE RSU grant of 250,000 shares and that was for saving the company). He buys shares at market prices with 25% of his salary. Finally, and here's where I know we disagree as well, he has aggressively raised capital at advantageous prices because ADXS needs every penny of that capital -- and it will need even more capital than it has now to ensure it can produce the results needed to achieve a $6B+ market cap. I don't "like" dilutive raises, but I accept them as a natural requirement of investing. If you think ADXS shareholders have been diluted badly, look what's happened to SYN. DOC has (and will) avoid that for us.
Look, we can have differing views on Dan's compensation and the appropriateness of his capital raises. My biggest complaint is the constant drumbeat from you on those issues when you have so much more to contribute that adds far more value to our collective understanding of this company.
Peace!
Requirements for biotech investing. For those who complain that DOC has not been driving shareholder value high enough soon enough, you need to read this.
https://www.forbes.com/sites/stevedickman/2017/04/12/the-long-game-in-life-sciences-181-billion-fund-baillie-gifford-invests-big-in-private-companies/2/#787f28366b83
Bottom line, anyone complaining about ADXS current market cap has no understanding of biotech investing. Period.
"Yes, Dan need to bring in upfront money instead of issuing stocks.
Anyone can issue stock to bring money."
Maybe it's not obvious, but "upfront" money is not free because the company has to give away some future revenue/ profit to get that money. Partnering deals ARE "dilutive." It just depends on the terms of the deal and the future performance of what was given away.
Dan's a smart guy and I trust him to decide whether a partnering deal or a secondary is the best deal for shareholders, him being one with much of his future wrapped up in the future value of ADXS.
"I would feel a lot better sitting on 200 to 250 but that's just me"
Me, too.
I would strongly encourage Dan to find another $60M-$100M for further trials, either through well negotiated partnering agreements or well-priced secondaries. If you're not OK with being diluted ~25% from here (if necessary), then you're in the wrong investment because you don't understand ADXS or biotech.
"Investors were furious that they did the raise!!"
Which investors? Not the pros, I can tell you.
Fbg0316, without the $30M raise we would NOT be at $16. $30M is about 10% of our market cap, so only considering the numbers, we might be at $8. But, that's not considering the negative impact on stock price the risk of not having the extra cash would have.
Mastiffs for life....what do you mean by, "Where would we be right now with cash in hand without it."?
Without the cash we would be at greater risk. You never know when you can raise funds again at as high as $13.
To be focused obsessively on current share price makes no investing sense. Focus on trial development status and cash. Everything else is noise.
The SA article is well-balanced, IMHO.
Show me where you got those numbers, I don't believe them.
Traderbx, you say, "Meishairwin.. I still think that you are [not] understanding ADXS true present worth... "
The facts you state are well known by all professional investors who put money to work in biotech. You are more impressed with those results than those professional investors are. And, please, don't argue "shorts are keeping the price down." To a minimal degree, yes. But, shorts can only drive price down to the extent there are insufficient buyers. ADXS's price may be 30% lower than it might otherwise be without short sellers, but 50% of what it should be, or 25% of what it should be? No, that's not reasonable. It's too steep a discount that smarts longs would attack.
To me, what ADXS "should be worth now" is a pointless question. It is worth what the market will pay: $7.82/sh ($315M market cap) at the close of trading on Tuesday.
However, if you ask me do I think ADXS market cap is likely to be much higher in 12-24 months? Yes, absolutely. And, here's where I (and you) are betting against the professional biotech investors. My bet is based on what I know about AXAL (and Lm technology) now, but only in regards to what that knowledge leads me to believe will happen with AXAL, Lm technology, and ADXS financial situation in the next 12-24 months. I believe ADXS market cap will likely be be $1B or more in 12-24 months (~$25/sh). But, that change in value requires future events that have not happened and that might not happen. We can debate what those events are, how soon they might happen, and what impact they might have on ADXS's market cap.
Talking about what a company "should be" worth "right now" is pointless, IMHO, because EVERYONE (who matters) knows EVERYTHING about any company NOW. On the other hand, discussing what a company could be worth in the future, based on what might happen in regards to the timing and impact of product development/ market progress, makes more sense to me.
And, in that regard, I think we agree more than we disagree.
dafreaks, it's probably a good idea to wait before adding right now. The biotech indices (e.g., XBI) have been very "toppy" and needing a correction. I'm hoping only about 15%... so, we're about half-way there now.
I'd wait until ADXS is below $7.25 before putting your finger on the trigger. I don't think that will happen in the next day, but maybe in the next week...
Iggy, yep, I'm with you. I'm betting that Lm will show strong results in the Ph3 and that repeated dosing will be shown to have increasing positive effect without serious AE's.
Still, as with today, anyone invested in this kind of company has to have balls of steel and realize they are making a binary bet: either the market cap goes to, you pick it, $2B, $6B, $10B, or it goes to $0 (or damn near).
Iggy, yes, I'm aware of that, but those numbers are very small, so I'd be careful about relying on them very heavily. Heck, even 50 is not a really robust number. And, don't forget, ADXS Ph2 did not have a control arm -- we're comparing our results against "history" and SOC.
Let's be clear, I am not "bad mouthing" ADXS. I am only making a case as to why ADXS is not valued at $1B+ right now and while results so far are encouraging, they are not so blindingly strong that, somehow, ADXS is being overlooked and "if only" big investors would take a look our pps would jump to $25+/sh.
fbg0316, you say, "Meishairwin, you mentioned investors really don't care if they are down now on their ADXS investment. So Fidelity bought back in August/September at $13.50 and are down close to 40%. I don't see how they would be pleased with how much the stock has gone down."
You need to understand how professional investors operate. If Fidelity had invested in a money center bank and its pps had dropped 40% in 7 months they would be really concerned; in fact, I'm sure they would have sold out long before that amount of price erosion.
But, when investing in small, pre-revenue biotechs, investors like Fidelity, Adage, Broadfin, and BlackRock are quite aware of the possibility that share price will fluctuate widely between when they make their investment and the point in time when the results that investment is supposed to generate show their value in the pps (which is often 2-3 years, or more).
What these institutions care about when investing in high risk/ high return companies is not pps in the interim between investment and result, but tangible product development progress that suggests the capital they invested is being employed effectively. I would submit to you that there is plenty of evidence DOC is using capital wisely because he is producing great product development results (as well as constantly looking to raise more funds).
mpreorder, you say, "More than 1 PIII will NOT be required. That was the whole reason for the SPA."
I agree that if our Ph3 provides unequivocal results we will not be asked to run another Ph3. I was implying that if our Ph3 has equivocal results -- and our Ph2 results suggest that's a possibility (see my other comment about our 38% 12 month survival having a 0.06 chance of occurring if underlying response is really only 30%) -- that we might have to run another Ph3 to overcome any doubt. Is that likely compared to either a clear win or a clear loss on our current Ph3? Hard to say, but I agree with you that needing to run a second Ph3 is not very likely.
Easymoneyman00... easy, big fella!
First, you imply I've said, "...there is no such thing [short trading] going on!" I've never said such a thing.
I'm a serious long investor in ADXS, but just find the "ADXS should be $1B/ $2B" talk not very sensible. Now, if you're saying "ADXS WILL BE" worth $1B/ $2B in time, I totally agree.
I agree that there is a significant "short" trade in ADXS, the numbers are obvious. If you're saying short investors/ traders are keeping ADXS from being worth $1B/ $2B right now, that's fantasy IMHO. Does the short trade keep ADXS pps from being lower than it would otherwise be? Yes, for sure. But... and here's where we can have differing views... I would be surprised, were shorting not allowed, if ADXS price would be much above, say, $12/ share. But, above $25/sh (~$1B market cap)? No, not likely.
Are shorts "trapped"? Hardly. Most short volume is from professional short traders. They have very sophisticated options trading strategies (computerized with HFT algorithms) that allow them to bracket their loss potential so that anything short of a buyout that isn't leaked will not cause them much damage. Most professional shorts (there are amateurs in that game, but they have little real impact on pps over time) are not shorting ADXS per se, they are shorting an entire basket of small, pre-revenue biotechs. Even a substantial loss in any one (which itself is hedged) would not have a huge impact on their overall bet that the vast majority of pre-revenue biotechs are net capital consumptive (i.e., they will ultimately not be worth more than what was invested in them). This is an easy game for them to play and win at.
You say, "Most analysts have had our share price above 1 billion now and for a year and a half." That's true, but those are price TARGETS with an indefinite expiration date. Analysts are not saying ADXS "should be" those prices except for the short interest. If there were enough "believers" in ADXS technology, then ADXS share price would be higher, yes. But, that's the issue: there aren't enough believers among those with the money to move the pps. Those analysts are the few believers (along with us).
I've described why I think there are so few "believers" among professional investors. I, like you, think Lm may well be a powerful immunotherapy platform. That's why I am invested in it. However, I am not among those who complain that somehow ADXS pps is not what it "should be." I don't CARE what the ADXS pps is now. I care what it will be when ADXS's Ph3 cervical cancer trial is completed and results announced. I care what ADXS's new Ph1 and Ph2 trials will be, especially combo trials, and when they will be initiated. I care whether or not we get European approval. I care if we get well-considered partnerships with the right terms and conditions.
So, why do you think there are so few believers in the Lm technology? There are a LOT of really smart PhD/ MD people out there working for serious professional investors. There are lots of smart PhD/ MD scientists in academia and industry. And, guess what, DAMN FEW are working on Lm or similar bacteria-based constructs. That should give anyone invested in ADXS pause. Still, I'm convinced the bias against bacteria-based (and Lm, specifically) is wrong-headed. That's why I am invested in ADXS (I looked at ADRO, but became convinced their specific listeria technology is not as strong as ADXS's).
One last thing you need to reconsider. You say, "...our vaccine is significantly better [than Avastin]" -- I assume you say that based on the Ph2 results, which is the most definitive data we have. AXAL does have better results than Avastin looking at our Ph2, but those results are not significantly better. Look at the mortality curves. Avastin has 30% 12 month survival. We had 38% survival (19/50). Statistically, there's a 6% chance that AXAL could show 19/50 when its true underlying effect is only 30%. Thus, we are not really "significantly" better based on this data (typically, 0.05 -- i.e., 5% -- is used as the cut-off for statistical significance).
Still, despite this result, I am willing to roll the dice that our Ph3, with a larger "N", will show statistically better results than Avastin, with better safety and at a lower price.
I am not a "soft basher." I am a realistic investor who does not get caught up in the emotion of the current pps or short manipulation. I look at the fundamentals and the likelihood a company will be successful commercially. I think ADXS is a good bet, but we will not know for at least 12-24 months. PPS between now and then is not *that* important -- trial results and trial initiation are important, European approval is important, partnerships are important. Those things are indicators of the likelihood of the ultimate success (commercial products) needed to make ADXS pps 5x-10x+ higher than what it is now.
Peter, thanks for the correction on my incorrect use of "could care less." Good English is something a could care less about, but don't.
fbg0316, "...investors under the new CEO's watch have seen their investment erode 30%." This is a VERY COMMON occurrence in early stage, pre-revenue companies. Investors at $12 are not at all unhappy with what they bought because they could CARE LESS about the share price between now and when the final bell rings. The "final bell" always has been: (1) successful AXAL Ph3 and FDA approval, and (2) more general validation of the Lm platform.
I repeat: any serious investor could CARE LESS what happens to share price between now and then. They only hope that Dan raises capital when price is higher rather than lower.
If you want a consistently increasing share price, you need to invest in ETFs (which you mention as comparisons). But, you'll never 5x-10x your investment with an ETF within 5-10 years.
Smasse, stop with the "manipulation" is preventing ADXS from being worth $1B-$2B. Nonsense. Are there traders and short sellers who are holding back the pps to some extent? I suspect there are, but not on the order of 3X-6X the current market cap. That's just silly.
I've stated the reason for ADXS's market cap: their technology is an arcane outlier. Few scientists believe it can deliver an effective, safe immune response to cancer cells. Only Aduro and Advaxis are pursuing it. Anyone with a PhD in this area thinks the listeria vector concept is cumbersome and hard to control. Investment analysts do not study it because the benefit from doing so is so small (you get to understand two companies). If analysts learn all about viral vectors and CAR-T they get to understand dozens of companies, so that's where they put their focus. If few analysts follow ADXS, then few institutions will invest in it because they don't have the information they need to make an informed investment decision.
The VERY FACT that ADXS has a low market cap should be EXACTLY the reason you are invested in it. Why? Because that situation says you've found something before lots of other people understand the value of what you've discovered. When will other's discover this value? I've said this before: a successful Ph3 (or two) on AXAL for cervical cancer and numerous (3-4-5) successful Ph1 and Ph2 trials using the Lm platform (some of them combo trials).
THOSE RESULTS are 12-24 months in the future. Once AXAL is fully validated, ADXS might be worth $1B-$2B (cervical is no where's near a $6B market at the price AXAL will be sold). Once the Lm platform is shown to have broad applicability to various cancers, now we're talking $6B+ valuation. But, that's not today, nor in 6-12 months. Maybe in 24 months; I hope within 36 months.
Traderbx,
Your point #1: Irrelevant. Each company's market cap is specific to its particular situation and status. What other immuno-oncology companies are worth is not that significant. ADXS's Lm platform is not followed or understood by analysts because so few companies (2 to be exact) are using this immunotherapy technology. Were ADXS pursuing viral vector CAR-T technology, there would be more potential comparisons.
Your point #2: So? Few people believe Lm will be successful because almost no companies are pursuing it or anything like it. Lm is "out in left field" metaphorically, thus the low valuation.
Your point #3: You assume the milestones will be reached. Odds are strongly against that happening, unless you happen to be those very few who "believe in" this technology. Not many people believe in it (see above explanation).
Your point #4: AXAL results are marginally better than Avastin, and only in a Ph2 trial in cervical cancer. There's a LONG WAY to go before AXAL succeeds in Ph3 (maybe more than one will be required). Even more, it will take years more to demonstrate AXAL works against a range of cancers similar to Avastin. And, it will cost much less, thus less profit, this lower valuation.... but, we're a LONG WAY away from a valuation based on volume and sales price.
IF YOU ARE RIGHT, ADXS will be worth much more than $1B... but the evidence is simply not in yet, and it will take 12-24 months for that information to be generated.
I think ADXS has great potential, but you and others here are WAY OVER your skis in believing what it "should be worth" now.
fbg0316, you ask a reasonable question: "what you think of the fact that the IBB is hovering around its 52 week high while ADXS is, as a matter of fact, closer to its 52 week low currently."
Two things. First, IBB is not the best metric for small immunotherapy biotechs because it is heavily weighted to big pharma. XBI is a better comparator because it is more heavily weighted to smaller biotechs (but still not a great comparison). However, XBI is also close to a 52 week high, so your point would hold. An even better comparator is Brad Loncar's Immunotherapy Index (http://www.loncarindex.com/), but it, too, is within 10% of its 52 week high.
Second, you cannot expect any individual small pre-revenue biotech to mimic ANY index. Small pre-revenue biotechs trade on NEWS and liquidity that affords trading/ short selling, not very much on general sentiment (except for the silly share price increases of many small pre-revenue biotechs ~Jan-July 2015).
ADXS's technology (the Lm platform) is an outlier technology that virtually no one in the investor community (the big money) understands. If you were a PhD/MD biotech analyst, would you spend your time learning everything about viral vectors and CAR-T that would help you understand 20-30 small pre-revenue biotechs or would you spend your time learning about listeria bacteria, which will help you understand 2 small pre-revenue biotechs?
Next, despite what we think, LITTLE IS KNOWN about the Lm platform from a clinical perspective. Sure, we have pretty good Ph2 results, but there are dozens of cancer therapies that have "looked good" in Ph2 only to fall apart in Ph3. Our results are good, but not revolutionary.
You might fault DOC on the slow Aratana/ PETX implementation, but the FDA (or is it some other agency) threw a monkey wrench into that deal saying a "field trial" was needed. Aratana obviously did not want to rush headlong into that (with the attendant spending and risk). Not sure we had a better option, though, and it was a brilliant idea. So, I for one do not fault DOC on that.
Bottom line, you somehow think that ADXS share price should advance on a schedule you think appropriate. However, few, if any, small pre-revenue biotech's have their share prices go into the billions prior to Ph3 trial results. A few do, yes. But, most do not. ADXS is like most.
As I said in my previous post, we have at least 12-24 months to go before I would start expecting ADXS market cap to move towards $1B or more. We need Ph3 results and we need multiple other Ph1/ Ph2 trial results, especially combo trials. That's gonna take much more money than we have -- so another $100M-$200M dilution is needed (or partnerships -- but they are "back-end" dilution, so pick your poison: front-end share dilution or back-end revenue/ profit dilution).
I understand the frustration many on this board who have been invested in ADXS for 5 or 10 years must feel, but all the evidence is we need to wait for another 1-2 years. We're on a solid track from a business progress perspective, which can be gauged by fund raising (more the better) and clinical progress. Share price means NOTHING in the interim in light of these other two metrics.
So, stop harping on share price. This is not an index, this is not a BP whose share price should increase somewhat consistently over time. This is a pre-revenue small biotech with unusual and unproven technology. When the share price increases, it will increase violently in response to news.
GLTA!
Traderbx, thanks for the institutional ownership and insider sell information. As for the latter, almost all (but maybe not all) of the insider selling is due to the exercise of options long before their expiration date. You can tell that is the case by the close proximate timing of the options exercise and the sale (I've checked the SEC form 4s and confirmed this) and more digging will show the expiration dates of the options so exercised.
When options are exercised (i.e., turned into actual shares at the strike price), there is income tax due on the value of the shares acquired in that manner. It is common for insiders to sell a portion of the shares they acquired that way to pay for the income tax withheld. That's what's happening here.
The interesting thing here is not the sale of the shares, as that's standard operating procedure. What's interesting is that DOC, and others, have exercised some options long before they expire. Now, there's only one reason you would do that: you believe the value of the shares is going to appreciate substantially and well before expiration. Exercising early has beneficial tax effects if shares increase in value well beyond the strike price (what we and DOC would hope will happen!). Exercising early turns gains that would have been taxed at higher ordinary income tax rates to being taxed at lower capital gains tax rates. ONLY if you were HIGHLY CONFIDENT in the appreciation of share value well before expiration would you take this action. This is VERY POSITIVE news for shareholders.
Traderbx, you say, "Why does Dan do this.. ADXS has sufficient cash on hand for 2 years... there is no reason to dilute..,
Dan needs to focus on a big buy out"
First, there is every reason to dilute. You need to understand the capital requirements of a company like ADXS. It needs as much capital as it would take for it to bring its AXAL product through what will probably be two Ph3 trials and to advance the Lm platform significantly (i.e., many more clinical trials of other targeted Lm therapies). And that amount of capital is WAAAAYYY more capital than it has now.
Why do I say this? Because ADXS will NOT be bought out until that is achieved -- or until it is obvious ADXS can achieve that on their own. Why won't they be bought out any time soon? Because the Lm platform is not "mainstream" immunotherapy and there is too much unknown about it for Big Pharma to risk its money until there is MUCH MORE evidence it works and has no serious downsides.
Pre-revenue start-ups like ADXS must raise capital WHENEVER THEY CAN at advantageous prices (higher than the pps is now and higher than it will be at various later points in time, probably). Why? Because if ADXS ever looks "needy," professional investors will extract a pound of flesh for that new capital -- i.e., you'll get MUCH greater dilution.
So, I don't think Dan is (nor should he be) trying to sell ADXS. It's way too soon -- and least 12-18 months too soon. ADXS needs at least another $100M-$200M to show it can take AXAL to FDA approval on its own, if needed, and that its Lm platform has a lot of breadth through multiple additional Ph1/ Ph2 clinical trials.
If you're invested in ADXS now, I think you should be ready to be diluted another 25%-40% before you can cash your investment out at $100-$150/sh in 2-3 years.