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This is for drug product filling. Not drug substance. Meaning many vaccine drug substances from different companies can gets filled here,
just a thought. would it be possible that the suppression of stock price is because an unknown company wants to buy out ADXS with pre-neogiated price but pending milestones completion. They came to ADXS last year, and Dan was ousted due to the offer. They have preliminary contract with good faith. If the buy-out price is pre-negotiated, then there is no need to run the stock price up because by running it as low as possible, it will benefit much more for those in the know.
I do not believe Amgen will be willing to accelerate the payment/acquisition before they see the Neo dosing data (which dosing is about to start). They are starting phase 2 now, but if the preliminary data looks good, i can see acceleration.
The indication that Aim2cerv is targeting is high risk local advance cervical cancer after completion of first line treatment. This means that if it works it will become the standard of practice for cervical cancer. The market is sizable if the vaccine can prevent cancer recurrence. Despite small patient population in US, i believe the company can still price the drug at premium. 5000 Patients at $60,000 to $70,000 a year conservatively (prevention means high health care value and benefit justifying premium pricing), which will give you $300-350 million revenue a year in US. Including Europe pricing approximately ~$30,000 for extra year gain for life expectancy, this will add approximately $200 - 300 million assuming there are 6000 - 10000 patients accessible to treatment in Europe every year. This does not include other markets where cervical cancer prevalence is high. Potential revenue of $500 milli a year market is not small!
Recurrent and metastatic cervical cancer will be a combo with Nivo, so pricing is more tricky. It is more important the Axal become the standard of treatment for early stage cancer than in metatstatic setting!.
Plus there are other potential indications (anal, head & neck) that once Axal is approved for cervical cancer, it will get there.
Noelle confirmed offering has been closed. It was closed the time they PRed it.
Viralytics did a huge equity placement a month (Jan) before being acquired (in feb). Doing a raise does not mean that there is no buyer or pending deals.
So if dilution does happen. We have 2 years until the P3 result and have 1 year of cash. I don’t think scenario is bad as people think. If we have a failed trial then I think I’m more worried. I like how P3 is moving forward fast with so many sites recruiting due to GOG network. That is the trial that really matters. What is happening here is the noise because if the product work, it will be the standard of care.
They are starting to meet the milestones they committed to after few months of delay so I stay optimistic. I really want to see Neo trial start because that is a confidence booster and potential to alleviate some cash concern.
The dual is being replaced by AXal, so the trial is still going forward. They need to start neo soon to endure they can trigger milestone which will get them probably another 1-2q of cash. We don’t know the terms of the neo dark, so I don’t know what to expect from P1 milestone.
They need another deal, which is clear and either that needs to come from Axal or HOT, something should take place. When they have additional cash, then they can raise remaining to get through P3, which is not that far from the finish line.
I think we are very close to have a partner. advaxis has always delivered when they stated that they are looking for deal. Asian deal, Latin America deal, Amgen deal ...all happened but took longer than we expected. Asian and Latin America deals now pays for big part of current p3.
This is no NWBO. Adxs has a fully funded neo program by Amgen... does NWBO has that?
That is not true. Adxs is still pushing hard through on P3 which is the most important thing for the company. The caveat is that Advaxis is doing P3 to further confirm the benefit. We are 2 years from finishing the trial and i do think there is a much greater chance of success when Adxs is given to prevent recurrence vs at terminal setting. In addition, 2 more phase 3 will start. One is investigators sponsor head and neck and the other is combo with NiVo on recurrent cc. The value of potential market is > a billion with only 2 years on horizon.
The company hasn’t said any of those is off the table. Maybe all delay we have seen is so all these events can be string together
I notice but delay is not uncommon in this industry. I still believe they are among to achieve the stated milestones.
I am hoping in next few weeks we get the following:
1. EMA submission
2. Neo dosing starts
3. Adxs-Dual IND accepted
4. Announce the head and neck ist trial
5. Trigger Amgen milestone payment
6. Keytruda+Adxs psa data
7. Initiation of Adxs-Dual trial
8. Announcing the EU partner
Two more years. Adxs-HpV will be the standard of care for cervical cancer. There 500000 women annually getting this terrible disease. Market size is huge and we have backing from all key opinion leaders in this field . The current price is a joke. Delays is common in biotech especially manufacturing, quality and compliance take time to develop. We are much further than we were before, despite low market cap, I do believe this is just temporary.
This may be the final fall before the news. I looked up LinkedIn on Adxs employees. I don’t see a lot ppl leaving companies after Dan left. This indicate to me that the company don’t have program issues.
We are the only company with potential cervical cancer treatment. This is not a competitive market so I do believe we can attract big Pharma’s attention.
Immunotherapy will always work better at earlier stage or prevent recurrence. However, the disease setting that we have been targeting for metastatic and recurrent conditions are ones where there are almost no or one therapy at 2nd line treatment. In the case of anal cancer, there is none. These are challenging cancers and area of unmet medical need. I believe advaxis vaccine works but we need to focus on getting one product on the market before moving into multiple phase 3
It is not. Our is recurrent metastatic anal cancer. This is first line
HOT antigens comes from the collaboration with Parker institute. There should be plenty of interest since the neoantigen platform is limited
Trial is still too small and early to tell but it’s promising enough that initially they were planing to advance the therapy with RTOG.
No therapy works in late stage anal. Adxs passed the study requirement to move forward. The next step is to combine with PD1 but Adxs is focusing its resource on advancing the both p3.
Stop stating Adxs having empty plant. The manufacturing plant at advaxis is absolutely needed because of personalized medicine. You are going to have your hands tied with CMO. And will be extremely costly relying on CMO instead of single use suite that Adxs is using now. Speed is key and to get product made with 6 weeks and advaxis needs absolute visibility and control.
I believe Neoantigen is the next wave and it’s about to start. Few trials started late this year and adxs will start early next year. There is a lot of attention in this area, I believe this will be the next big thing after CarT
I think PSA + anti-pd1 is very possible to have good data if immune tolerance can be overcome. During annual investor conference, they demonstrated continual expansion of new t-cell clones during repeat dosing in combo arm vs initial expansion in mono arm. The t-cell avidity and specificity to neoantigen is much higher than self antigen.
The platform works but it’s a lot to do with the target. Self antigen should be a thing of a past. HPV works because it’s an exogenous target. It’s going to be neoantigen space starting from now.
Just make sure no margin. I do believe when CEO says that they are signing a partner that they will. It’s rare that they make that kind of public statement. Advaxis is trading like it failed a P3 which still makes no sense to me. Question - has anyone on the board spoken to Lombardo?
the IST trial for head and neck could be registrational. Partnership discussion would definitely be announced, just depending on when. They have artillery of HOT vectorss. things could work out really well timing wise if they get a partnership, secure funding, start NOE get milestone payment, provide Sellas with material to start Phase 1 get milestone, and as stock rise, raise 20-30mil. This would get them easily pass EMA review and approval.
The goal for these tutes are to take this down to make a lot of money and then take it up and make a lot of money. There are very few stock that they have opportunity to do that. In order for them to do this, the company need to have strong science and have potential to license or partnership. They can manipulate between events until the drug is finally approved
I still don’t see any bad news that warrant this drop. At least clinically we haven’t heard anything. If some financial entities have intent to attack this stock, there is not much management can do to stop other than continue to push the clinical programs forward and work on license deals and wait out this attack. There are tons of other companies with failed trials that valued more than adxs and without revenue generating partnership.
EMA was not supposed to file last summer. Gog final data was not presented until earlier this year. For a biotech company, advaxis has not had bad clinical news that warrant such drop with potential milestones and partnership and filing in horizon, this trading behavior does not make sense.
I feel the stock price has no relevance right now because you can see 500k traded barely changing the price yet you can see 10000K shares changing price by few percent. This makes no sense at all.
I still have not seen the bad news that justify the stock price drop starting September. very hard to believe the Adage will really sell at this point instead of much higher, which really doesn't make any sense to me.
If it's because of poor clinical results, they would have to reveal that because it's material information. So far we all know the results from most of p2 clinical trials except for her2. It's been 3 months since Dan's leaving the company. IR already stated that Dan's leaving had nothing to do with the clinical data and they are liable if they lie. They could have the option just not to say anything.
I don't see that as a bad thing. A lot of time for complicated biologics, your process is your product- and advaxis probably has more experience with listeria than Amgen. It would have taken longer if Amgen needs to do this project internally, i.e resource prioritization and all that
I don't think they have major manufacturing issue, I think the My have delalyed in their start up activities which is not uncommon, it's better to do things right than rushing and compompromising quality
advaxis is targeting multiple tumor type vs 1 in aduro. Since Amgen is funding this, adxs can go with full throttle.
If there is going to be a partnership with good upfront payment, maybe it explains why we have this attack...
There is no bad news associated with this drop. It's been two weeks since this action has started. If this is plain manipulation then I think they will change and manipulate it up. It's about time...and company is making great clinic progress...the price drop is not warranted.
I feel that sometimes biotech stock price can be irrelevant for a period of time, it doesn't reflect anything, management, clinical progress, value and all that
If you look at NK, the company run by Patrick Shiong, billionaire. It does not avoid the fate of volitity of biotech stock, great management.....went down 2 then back to 6...the only way to avoid this volitity is to get a product on market.
I don't see why they can't find a partner. I think the data is strong and they indicated they prefer to go with a distribution partner. I think the company is taking this filing very seriously and I think they will get the filing out very soon. Remember they already have EMA CAT reviewed major part of their filings so the bulk of it should have been ready while back
Clinical programs like these are extremely complicated. It is not uncommon for delays. 1H could also be early 2018. Their P3 is crusing along and you don't acknowledge that? I do think they need to not be too specific with milestone dates. Dan used to do that and make things predictable. I am hoping that Lombardo is under promising and over delivering starting from now