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Fundamentally, they are worse off now because they have much more clinical data but it hasn't been good enough to generate interest casting doubt on whether they will be able to bring to market and commercialize the platform.
Amgen is not a hedge fund. So you are saying Amgen along with all the other institutional investors who sold out of ADXS over the last couple years as they assessed the clincial trial data are also on the wrong side with the only ones left on the right side are retail investors and low quality toxic financiers?
Exactly, no manipulation, the market is pegging the company at fair value based on the data in aggregate not coming in very strong. The platform and science is not what we all hoped it would be. Amgen even had high hopes to the tune of $65m before they saw the prelim NEO data and recognized the platform was not going to be a game changer.
What to expect at AARC by way of NEO and PSA data...nothing very impressive. If it were, Merck would not have flushed $65m down the toilet and terminated its deal with ADXS, and we've already seen plenty of PSA data but it hasn't been good enough for Merck to put skin in the game, not even a back loaded deal to lock in rights. The nasty warrant move today ahead of the reverse and dilution is more evidence ADXS is a price taker and not in any position to command a capital raise on good terms because there is little demand for the clinical program and platform. GLTA
This will be the third dilution on horrific terms and a reverse split. Anyone who does not sure the company is desperate with no interest from BP or reputable imvestors is either deeply underwater or new and doesn't understand the company's track record. Those so called term sheets are nothing more than entities interested in getting rights for free like the India deal, the Asia deal, the Canada deal, the South America deal, the PETX deal. No upfront money or we wouldn't have seen the crap filing today.
"The science is stronger than ever."
Then there is Amgen, who by its actions after $65 million in, believes the exact opposite, but hey, what does the largest, most successful biotech in the world know.
You repeat the same conspiracies theories over and over again without a shred of proof. Who's paying you to mislead and make it sounds like the company is in better shape than it is?
Well Merck has seen the more mature PSA data and and they have not believed it is good enough to partner. Seeing that no other entity has any rights on PSA besides ADXS, you would think Merck would want to at least secure a licensing deal for worldwide PSA rights if the data were promising. My point is that between experts at large pharmas and biotechs who analyze data and promising technologies for a living and experts at institutional investment organizations whose jos it is to identify promising investments in aggregate do not believe ADXS' platform has shown good enough data to make a meaningful advancement in cancer treatment and hence a poor investment. If you don't believe me, just look at the money flow, culminating with Amgen's exodus. All that is left for the most part are retail investors and toxic financiers.
So I'm curious, if ADXS' data has been as good as you would like to think, why has the company been not been able to attract a deal in two and a half years and the deal they struck two and a half years ago was recently terminated and the comonay is a penny stcok now with a collapsed valuation and about to do a reverse split? Doesn't sound like comonay with strong data and a promising platform. Perhaps the institutional investors that largely sold and lack of BP interest implies they don't think the data has been good.
Thanks, I was thinking it was earlier stage. My other point is the main point, that while the % CR at a surface level may appear great, when compared to current treatment available, it doesn't add much benefit. If current standard of care were only say 20% effective big pharma would have jumped all it, but considering simple outpatient surgery is so effective that's why there was not much attention to ADXS' results.
The reason it did not impress much is because simple outpatient surgery is more than 80% effective so ADXS didn't add a meaningful benefit over current standard of care. Also, it was not advanced anal cancer, it was early stage with a high likelihood of recurrence I believe.
Agreed, it's fair to say if the data to date in the PSA trial had been compelled Merck would have already partnered up with ADXS in anticipation of a registrational trial.
Most would consider a decade long-term and over that time nearly all ADXS shareholder value has been wiped out. EOM
I stand of attacking me, let's hear your evidence that...ADXS is not going to do a reverse split, about to strike a large big pharma deal, the only reason Amgem terminated its relationship because it feared Merck is about to but the company and so forth and so on...
Right...at this point it's pretty clear the tech has fallen short as the trials have not produced the data expected, which explains why Amgen bailed, Astra and Merck didn't strike a deal and the majority of institutional imvesotors who bought in the early years habe since bailed. No manipulation, just fair value reflecting demand of the platform. In hindsight, the only manipulation happened in 2015 when ADXS hit $30 similar to the dot com boom that peaked in 2000. Companies like pets.com in 2000 never came back similar to ADXS now.
If ADXS increased 10x from here, it would still be approximately 75% below the price investors paid to recapitalize the company from 2013 to 2017. The kind of massive value destruction seen with ADXS over the last several years, while poor management has been a factor, at the end of the day points to one thing: the clinical trial data has not impressed investors or Big Pharma. Kicking the can along seems to be par for the course. When it started to become clearer the first gen platform was not that effective, ADXS re-framed it to "combo treatments are our future" then when the combo data came out and Astra stepped away and Merck opted not to step up, ADXS re-framed it to "Our neoantigen platform is the future of the company" and now that it's becoming more apparent NEO may not be what it will billed to be if Amgen's assessment of the data is any indication, ADXS will re-frame it to something like, "Our personalized NEO program proved to be too costly, the real future of the company is our off-the-shelf HOT platform"...until it's not.
"...assuming Merck wants to make a deal."
That is a huge assumption that looks unlikely, because Merck has had a non-paying collaboration with ADXS since 2014 supplying Keytruda and since then ADXS has generated combo trial data for both PSA and AXAL (with Astra Zeneca). The iron has been hot in terms of large companies locking in rights for promising small biotech platforms, and Merck has not stepped up to strike anything with ADXS.
It's all data driven, and the data has fallen short. Just ask Amgen why they terminated their deal with ADXS and ask Astra Zeneca and Merck why they passed on doing a deal with ADXS after seeing the AXAL and PSA combo data. 2015 was about hope that the science would play out and since then the data has told a different reality.
ADXS' time already came...in 2015.
If the PSA data were good, Merck would have already struck a deal with ADXS, and if the prelim NEO data were good, Amgen certainly would not have terminated its NEO deal and flushed $65 million already invested down the drain.
ADXS gave away AXAL cervical rights in deals covering Asia ex-India, India, South America and Canada. So the question should be where does ADXS still have rights - U.S. and Europe, but no one has wanted to partner the program in those markets. And the other markets ADXS gave away the rights for nothing upfront except for $10m for the South America deal.
Newbie: I just came across this promising little biotech called Advaxis that has a very cheap valuation and looks like a good buy. I mean the thing is trading at cash value.
Seasoned Veteran: Not so fast, Advaxis is currently trading at fair value, as the science is worth very little. The company is not new to the block, as it has been running clinical trials for over a decade but has not generated very impressive data.
Newbie: Yea, but I see the company has a late stage asset, AXAL, so most of clinical trials have already been completed, so can't the company sell the asset or strike a lucrative deal to help the cash position since BP is starving for new products.
Seasoned Veteran: Unfortunately, ADXS has been agressively trying to partner that program for the last two years, but no one is interested as the data is not that good compared to all the competing therapies both in development and currently available.
Newbie: I still think the company is worth at least $100 million if it can just address the cash issue.
Seasoned Veteran: The risk now is that the company will do a reverse split and turn once again to low quality toxic financing. You may want to wait until that before entering. At least you're not a long-term shareholder who at this point will likely not get their money back because there is no demand for ADXS' tech from BPs or investors. Aduro, which as a very similar tech, pretty much shut down their LLM program because the clinical trial data wasn't good, which was the canary in the coal mine for Advaxis.
Cattdog, they've been looking for an offer for more than two years across three CEOs. It's not about management at this point, it's about demand for the platform. Those who invested back them made a bet the science and platform would play out in a way that it hasn't, unfortunately.
Check this press release on Feb 6. The statement below refers to preliminary clinical data from ADXS-NEO, which was seen by ADXS and former partner Amgen. Also, this is the first time I'm aware of ADXS making plan to combine NEO with a checkpoint inhibitor. There's no black and whites here, no definite failure or clear-cut sign that failure will come. It's all about probabilities and in my opinion, this may have been what happened: Amgen saw the initial data and it didn't meet Amgen's expectations "at that early stage" coupled with the concerns over the manufacturing costs (as evidenced by the delays and changing the trial parameters related to manufacturing). So you have some signs that the NEO platform may not turn out in the end to be what Amgen put $65 million on the line for, and to justify the high manufacturing costs, Amgen needed to have very high confidence in the future trial outcomes, and for one reason or another they didn't get that signal from the initial NEO data so they pulled the plug. Then ADXS realized that to increase the effectiveness of NEO it would likely need to add a PD1 to the trials, which is what zillions of other competitors are doing in hopes that they have a winner. Meanwhile, ADXS' only paying partner pulled the plug, as did almost all reputable tutes over the last few years, so ADXS is left having to do a reverse split and another dilution on terrible terms with toxic low quality financing.
“We have a broad pipeline of drug candidates being evaluated for multiple cancer types at various stages of development. We anticipate our first drug construct from our ADXS-HOT program, ADXS-503 for non-small cell lung cancer, to enter the clinic later this quarter.” said Dr. Gutierrez. He added, “We believe that our neoantigen-directed drug candidates will likely be used in combination with checkpoint inhibitors and have the potential to significantly impact the cancer treatment paradigm.” He concluded, “The preliminary clinical data from our ADXS-NEO Phase 1 study demonstrate broad and rapid anti-tumor immunity. We are looking forward to providing clinical data read-outs from several studies throughout 2019.”
https://ir.advaxis.com/press-release/conferences/advaxis-presents-overview-its-lm-platform-and-neoantigen-directed
I meant Amgen lost confidence.
It's probably a combination of things, but it all points to the same thing, ADXS lost confidence that they investment would pay off, otherwise they would have continued with the partnership. Higher than expected manufacturing costs are probably part of it, but if you have a game changer that won't matter as much, so couple with concern on costs with the initial data which may have not Amgens expectations at that early stage, then the decision is attributed in the nice wrapper of "change of strategic direction".
Mastiff, ADXS has released early data on the first patients dosed and it's public information. I'm not as interested in how ADXS may have spun but in the actions of the one company that had skin in the game backing the platform before the data was available and since then after their experts evslauted the data had a change of mind.
The Aduro trials were further along, as I believe they missed a primary end point on a phase 2 trial. Berlin said one of the reasons Amgen said they terminated was because of the high risk, which essentially means the initial data pointed to lower probability that the platform will be successful compared to Amgen's original underwriting of the program pre data.
Biotech deal-making is hot, but only for companies with promising data and platforms that are in demand. Then on the other end, you have companies that are valued at next to nothing for good reason. Amgen got a glimpse of the early data from NEO and decided further investment was not worth it and they would rather write off $65 million already invested since they think the probability for success is lower now that they have assessed the initial data than when they initially invested on optimistic expectations without data in hand.
Wake up, the lack of deals and lack of investor cash is the valuation of the science. The $250 million ADXS raised didn't result in strong enough data to attract further investment on good terms, hence the reverse split and toxic financing. Capitalism 101.
Adxs has been a public company for more than 12 years and is about to go through it's 2nd reverse split in less than six years. The company has a late stage trial but has not attracted one monetary partnership except for Amgen, which terminated the deal when early NEO data became available. ADXS is not the new kid on the block that everyone is waiting to see if it delivers. ADXS has delivered and has fallen short of expectations, hence to drop from a $1b valuation in 2015 to less than $50m today and why the company now only has access to toxic financing.
CIN trial under Tom Moore and the cervical combo trial with Astra pretty much failed. Pretty much meaning CIN was stopped because the data was "unreadable" and the combo trial has no hard endpoints other than survival, and Astra passed on partnering and ADXS is not advancing the trial. I would call that failure.
At this point the science is worth peanuts and pretty much failed. Aduro ended their LLM program because of failed trials and shifted to their other constructs. Unfortunately, all ADXS has is LLM and management is milking it to the last penny even through pharmas are not interested.
He's a great CEO, but he can't change the science or the clinical trial results. which is what the market is valuing.
RIP ADXS shareholders, you have been wiped out. No deals, no pharma interest, no manipulation, just lackluster data, Amgen action louder than words regarding the prospects of the science and platform, now more dilution and toxic financing, rinse and repeat.
Term sheets are a dime or dozen and mean nothing if the terms are not strong. It's likely these so called terms sheets do not offer much upfront cash, otherwise ADXS would have executed a deal that was strong enough to get the stock over $1 without needing a reverse split.
For the sake of sharheholders, hopefully it passed, because the alternative is delisting and bankruptcy. You can't blame current management for what's happened. Berlin has done a great job controlling costs. At this point, the science is doing the talking and nothing Berlin can do can make the data stronger or force a pharma into being interested in making a monetary investment in the platform.
So Merck buys an earlier stage company for $300 million, when they could buy a later stage company, ADXS, for probably around $100 million but they have chosen not to or even strike a partnership deal with ADXS. What does that tell you about how they view the potential of ADXS' platform?
Because the efficacy hasn't been strong enough relative to other therapies and combo regimens in development. If the trial data had been stronger, ADXS would have a partner for AXAL and PSA and Amgen would not have decided it was better to loose 65m than put a another dime in NEO because the probability for commercial success is low.
Renaissance is a quantitative hedge fund, meaning they don't make investment decisions based on a company's fundamentals or expectations of certain events happening, so your theory is untrue and not supported by facts.
"Renaissance Technologies is a quantitative investment management company trading in global financial markets, dedicated to producing exceptional returns for its investors by strictly adhering to mathematical and statistical methods."