Ayala Pharmaceuticals Inc (ADXS)

[gbrown6332]

The near term event that will impact the longer term future of HER2 is PETX gaining USDA approval to commercialize the construct for veterinary application. I know we're talking dogs vs human applications but the similarities and parallels of the target cancers are very strong.

The required PETX field trials of AT-014 were good or PETX could not or would not have proceeded with the USDA conditional approval request.

I believe researchers are well aware of the human applications for HER2 and the broader implications if it's successful treating canine osteosarcoma.

G.B.

[Easymoneyman00]

Hovacre, I totally agree with you! My whole point was Dew Dilligence was the one implying that if our HER2 results were that good that Lombardo would continue to pursue HER2 at this time. I'm stating that we need to conserve cash and pursue our phase 3 trials to bring them to fruition. My whole point was calling out DEW on his remarks about our HER2 trials. He just stated that if they were that good we would still pursue them even if money is tight. Lombardo is doing the right things for us the shareholders in my opinion starting with slowing down ontrials that are too far out at this time. Then using what cash we have on getting AXAL to some kind of approval without diluting at such low prices. I'm not against dilution if it's done at much higher valuations than down here! Lombardo to me is being fiscally responsible with our cash and is doing everything possible to add value to ADXS' s share price! Patience is what's needed now he just came on board and needs a little time to turn the ship around in the right direction. Shorts we're hoping for major cash burns monthly like Dan had planned but now the board has put in a CEO to right the ship and steer us to be a revenue producing company inspite of the damage Dan had done by going full bore on every trial in our pipeline. Lombardo realizes that if he can get AXAL approved in the EU we will be off to the races!

[blueyedcatch]

They already have the safety data,it was the primary endpoint of the study,and it was good. They`re waiting on the secondary endpoint data,which was efficacy,and they should be getting it in a few months.

[Gantor50]

Have you heard or read anything about the safety profile of ADXS HER2 construct? I have read comments over the years that suggests it would be wildly effective, but could generate some side effects in humans, potentially dangerous for a certain small percentage of patients.

I bring this up as it relates to cost. Hypothetically if say 5% of the patients were at higher risk of life threatening complications, HER2 with legitimate life saving efficacy but side effects could still be approved (eventually) and be incredibly lucrative, but those trials and working with FDA thru the process could take some time and be very costly.

If that is true it would be logical to sell or license to a Big Pharma who could easily take on the heavy lifting and afford the cost.

Even if safety profile is no problem at all, it still makes sense to sell or license this out due to costs involved.

[XenaLives]

... and will probably be shopped around looking for a partner.

The efficacy data from the human HER-2 trial is being compiled and will be released at some point in the future.

[williamjay]

I have spoken with Noelle about the HER-2 human trial where it was being used for multiple HER-2 cancers. The human trial was ongoing. The company decided to stop pursuing HER-2 because the next step was a study in pediatric osteosarcoma which is a very small market. As much as the company would like to help those patients, it needs to conserve and prioritize the use of its resources. The efficacy data from the human HER-2 trial is being compiled and will be released at some point in the future.

[hovacre]

Even if the HER2 canine trials went very well, it makes sense for ADXS to pursue the other indications for their LM platform first, especially those in phase 3. Furthermore, HER2-positive tumors have a lot of existing and upcoming competition.

Fantastic preclinical results still puts you at least 5 or 6 years out from a product. Likely longer. It should not be read as a strong indicator that the trial went poorly.

[tx_farmer]

Isn't that a 3 to 4 step process? ADXS shaved off weeks of a multiple month long process. Such idiots, right? or maybe they are increasing efficiency/profit potential!

[huskercatman123]

Any idea why the history of this trial shows "product_exported_from_us"?

[huskercatman123]

Thanks Julius, that was about 80,000 beers ago so my memory is probably fading perhaps. Right before the clinical hold aye; was only one patient dosed or did the trial resurrect after the hold was lifted? Thanks

Interesting that this is about the time of the EU patent filing.

[Julius_Kelp]

Hey Husker,

Check these out.

http://www.fiercepharma.com/r-d/advaxis-targets-her2-cancers-first-human-vaccine-trial

https://clinicaltrials.gov/ct2/show/record/NCT02386501

[huskercatman123]

Hi Iggy, lots of talk; but never saw human dosing? Just my drunk backwoods take.

[ignatiusrielly35]

Now I'm confused. I thought there was an HER2 phase 1 running somewhere? If not, then what "data" did they look at, as per the pr about putting HER2 on hold?

[Easymoneyman00]

Your exactly correct Huskercatman! Seems the canine trials are going great yet we have no human trials to date. Yet some people here would want you to believe our HER2 trials haven't been successful enough to warrant further trials? What? Lombardo is conserving cash at this time .. We're not abandoning our HER2 trials all together we're just not going to spend money starting a new trial! In fact we have fast track designation .

[Easymoneyman00]

I guess our HER2 canine trials aren't good enough to pursue them in human trials? I thought our PETX trials were going super? Seems the dogs are surviving way past SOC treatments so why are we not good enough for pursuing HER2 in human trials?

[gajj]

spread the word. I did

[Keithz]

DITTO

[tx_farmer]

Very cool, thanks gold007

[island man]

Blue you did what you liked/loved now this ADXS better ramp-up so you can pay someone to make it like it was or even better.BOL to us

[gold007_2000]

check out https://aim2cerv.com/

[Ira 1]

I am waiting it out as well

GLTARL

[blueyedcatch]

Ruined. The town gave the big trucks that pick up the landscape garbage to Fema,and they did`nt clear it away for over 4 weeks,,so my lawn is totally dead where the garbage was sitting. Need Adxs to go to 50 for me to even consider re doing any of the damage. I should`ve never did an elaborate landscape in a hurricane state.

[island man]

That my friend is the "STOCK MARKET" for every buyer there is a seller and vice versa. So how is the property after the ravage?

[ignatiusrielly35]

I was commenting on your theory that Dan was a "mole" for Adage. Try reading it again.

[CATTDOGG12347]

I’m buying some of them:)

[raja48185]

I can understand your argument.

Let us see how it works out.

I am not selling either and am willing to wait it out.

[attilathehunt]

raja -
So why does BP not go ahead and buy ADXS...?

Maybe under DOC it wasn't for sale and maybe now it is and deals take time. Given we have multiple partners the due diligence period is going to take some time. Any potential buyer would need to get intimate with all the other partnership and I bet it gets tricky. Let's say AZ is looking to buy us outright. Before they open their wallets they will want to see what is their exposure with BMY, Merck, Amgen, etc. It's not going to be easy to share deals with other competitors. If you were BMY, you wouldn't want AZ looking under your sheets.

This will take time. Because of this complexity (all the deals) I believe that is why the BOD handed it over to Lombardo to sort out and to get it done.

He needs time and thus the shorts opportunity to drive share price lower. Make money, cover, then go long. The shorts (smart money) will profit from both directions.

I'm holding and will not sell. Selling now is like being an accessary to a crime. Let the shorts work to cover. Im not going to make it easy on them by selling. I would have sold long ago if I didn't believe in the ultimate outcome.

Have a good evening.

[raja48185]

attilathehunt,

You know that it is worth a lot more than $15 - and I do not disagree.

So why does BP not go ahead and buy ADXS, if folks like you and me know that is worth more than $15? Certainly they are more knowledgeable than any of us here.

[Batermere]

raja.... good question. Evidently, based on the clinical results that we DO have from GOG, head and neck cancer and anal cancer (even though the sample sizes were quite low) .... the Reward VS the Risk is not quite there yet according to potential BP suitors. I find that baffling in today's Biotech landscape when BPs are paying a lot of money for small Baby Biotechs that have NO products as far along as what ADXS has currently. It's a real head scratcher, I must admit. Maybe it will take EU Approval to get there. Unfortunately, that is probably going to be at least a year away as slow as ADXS is. They just continue to hobble along at a snail's pace with ZERO sense of urgency. It's very frustrating.

[blueyedcatch]

Plus they timed it to break the stock down below the 5.20,and cause other to sell,via stop losses,etc.

[blueyedcatch]

The silly thing is that every share sold is bought,and the difference between a buy and a sale is never more than a penny so when posters talk about all the shares being sold,someone`s buying them all. When there`s more buyers than sellers the share price rises and vice versa,but shares sold are always bought by someone.

[fbg0316]

Bourbon that sale by Adage was likely to cover a short position (i.e., selling the shares they bought at $19 for a tax loss to offset the gain from covering a short position put on on the $20s).

[samk]

all big blocks should be considered as a buy, otherwise the price would be sharply dropped, IMO.

[Bourbon_on_my_cornflakes]

based on nothing? didn't Adage file a sale document with the SEC?
and Adage was about as long as you can get, they are practically insiders becuase their long position was so big. did you think at all before replying to my original post?

[attilathehunt]

raja -What is holding them back?


No one is holding back because what you suggest in unrealistic.

I don't know a fair price but I do know this is worth a lot more than $15.

[ignatiusrielly35]

The Adage conspiracy with Dan is a fantasy based on nothing. And I'm talking about long tutes, not short Hedgies with their robots.

[gajj]

If Advaxis' formulations are cheaper than the alternatives and more effective then the only limits to market penetration are production capacity and distribution. we know that production is readily scaleable and we can assume that lenders will be willing to finance additional plant if the market warrants.

[Bourbon_on_my_cornflakes]

PLenty of evidence here that Tutes get very emotional. Seems Adage sold off a big chunk when their mole, er CEO, got canned. And someone has had a hard-on for this stock since it started plummeting at $30.

[island man]

Hammys would be the bomb but right now Washingtons would do

[ignatiusrielly35]

Three who sold under 10? Out of how many? 40? Tutes sell for various reasons that have nothing to do with them believing that a stock is fairly valued at the current price. By your own account, the average analyst estimate is $23 a share. Which is not even a full value estimate, it's a price target. Tutes have analysts. You think any of them place a value on ADXS of $15 a share? I seriously doubt it. Adage bought shares at 19 2 1/2 years ago, and the company is much further along now. You seem to think that tutes get emotional and desperate, like the retail here. They don't.

[DewDiligence]

Why is BP not making any effort to grab Advaxis NOW if everyone here believes that this company is going to be worth billions in a matter of 18 to 24 months?

Actually, not everyone here thinks ADXS will be worth billions in 18-24 months.

[mpreorder]

LOL....you don't understand what I wrote. Go read it, it still pinned.
I said 10% likelihood of success, of that, 50% market share.
That's 5% in my book.
Very conservative.

And we have absolutely NOTHING in common with DNDN. Completely different tech that only added 3-4 months to life at best at an astronomical cost.

[maplestory]

ASAP

[sandman44]

SELL THIS AND PUT IT OF ITS MISERY ADXS

[raja48185]

Open Question

Why is BP not making any effort to grab Advaxis NOW if everyone here believes that this company is going to be worth billions in a matter of 18 to 24 months? We would have read about some rumor that some BP is going after this company.

Heck! even a 200% premium from the current pps would be a steal for them, given the huge potential . It is not that they cannot afford to pay a few hundred million right now. They can recover their investment in a couple of qtrs. once they have ADXS making them money.

Obviously BP knows more about ADXS potential than anyone here does - or does anyone here challenge that argument too?


What is holding them back?

[fbg0316]

You are making a generalization about all tutes knowing the value is much more than $15, but I just gave you an example of three who sold under $10.

[ignatiusrielly35]

Well, I disagree. The tutes know full well that the stock is worth many times the current share price. They have actual analysts who figure that out, as opposed to retail thinking "oh no, the stock is down, how can I get out of this regardless of price?" Any tute with a clue who invests in clinical biotech understands the manipulation game and the timelines. They also know that management may have made mistakes but nothing that justifies this share price, or even $15.

[fbg0316]

Not necessarily - since tutes like Broadfin, Pictet and T Rowe Price sold out for under $10, there will be plenty willing to sell out for $15, especially given low investor confidence that ADXS management can do any better.

[ignatiusrielly35]

I doubt they would need to fight off a buyout offer. The tutes would reject $15, imo.

[ignatiusrielly35]

Or they are legitimate trades at the market in a dark pool. The pools have much larger quotes, all tutes.