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The Q3 PR incorrectly uses 9-months ended figures, causing cash burn to look worse than it is: https://www.investorvillage.com/smbd.asp?mb=6524&mn=2976&pt=msg&mid=17519954
Let me google that for you: https://www.google.com/search?q=%22According+to+my+valuation+model%2C%22+%22seems+to+be+fairly+priced+at+around%22&oq=%22According+to+my+valuation+model%2C%22+%22seems+to+be+fairly+priced+at+around%22&gs_l=psy-ab.3...9497.10353.0.10580.4.4.0.0.0.0.101.382.2j2.4.0....0...1.1.64.psy-ab..0.2.200...33i22i29i30k1.NC8_02ddU2g
The writing may not be 100% automated, but its close enough to be ignored as spam.
Why are you so optimistic on Lm tech?
I like it (obviously), but I worry it muddies the waters by introducing many listeria antigens in with the cancer antigens. This may be a fine compromise given how easy and cheap bacteria are to engineer and produce, but it seems to me better platforms will eventually come along. Hopefully we get to market before then.
I'm recalling studies of other vaccines showing the immune system to be limited in the specificity of its responses. Is my understanding of immunology lacking?
Here's the trial's poster. It goes into more detail: https://www.advaxis.com/wp-content/uploads/2017/06/A-recombinant-HER2-Neu.pdf
Wow, have any other canine osteosarcoma treatments worked this well? The trial shown on page 6 doesn't have a control arm and n=18, but at 800 days the disease-free survival appears to be 50%. In the other trials I can find with dogs treated by radiation, they're all dead by then.
Its especially heartening as its the same format as AIM2CERV: the use of Lm tech to prevent recurrence after traditional treatment.
Also of note is that Dr. Mason disclosed being invested in Advaxis.
https://www.advaxis.com/wp-content/uploads/2017/06/Lm-LLO-Immunotherapy-plus-Radiation-Delays-Tumor-Progression-and-Prolongs-Survival-in-Osteosarcoma-1.pdf
My impression was that Lm was always better suited for prevention rather than treatment of metastatic cancer, but that these trials take longer and/or the FDA is less likely to allow them.
I invested in ADXS because I believed a cheap way to make cancer less likely to metastasize would be extremely valuable. Then the NEO-AMGN deal happened and it looked even better.
This has been my biggest fear with ADXS, but I'd expect to see more insider selling if this was the case. Its hard to argue DOC didn't believe in the science.
So you think ADXS is outright lying? Nothing had changed in respect to AZN's partnerships with ADXS. AZN did obviously wave their right of first refusal and/or decline to partner with ADXS on cervical cancer, so this statement could have been misleading (I can't be sure because I lack the subscription to search and find the exact quote).
I think "there is no ‘smoking gun’ as it relates to our products, performance or research" paints a pretty clear picture. If you think ADXS would straight-up lie like this then I think we all ought take our money elsewhere.
Long-term philosophical differences don't result in immediate termination with no ready replacement.
Could BMY or AMGN have offered to buy ADXS for $1B, which Dan adamantly refused to the point of resigning? Sure. He might've also sexually harassed an employee. Whatever the cause was, my bet is that it was an acute one.
Depending on the accuracy of these algorithms, I can see the ability to deliver many potential antigens as a large boon. Though I definitely agree there will be tradeoffs here.
Has Amgen commented on why they chose ADXS?
I believe it was stated that many selected neoantigens turn out to not actually be immunogenic. If this is the case you wouldn't think they'd do much to influence the immune response.
Is there reason to believe there is data to present from part 2 of this study? It was my understanding that enrollment (n=90) was probably not close to complete.
Completion of enrollment in the dose escalation phase was completed in July of last year. Obviously they did shout these results from the rooftops. Though the clinical hold ruined a lot of it, the one CR which only started once the hold ended was promising.
There was a single slide (20:57) of this study in the presentation, but it was skipped over without comment. Was there anything more said on it I'm no remembering, perhaps in Q&A?
I wasn't happy about the durvalumab study not being mentioned either, but I simply assumed data from it was not available. If data was negative, it was my understanding that ADXS officers would be obliged to inform investors. You seem to be suggesting ADXS is hiding poor data?
ADXS going with Opdivo over durvalumab seems like less of an issue to me, as Opdivo is the better drug and INO seems like the bottom of the barrel.
Dew, can you expand on why you believe AXAL is only "a general-purpose immune-system booster"?
Thanks.
Per yesterday's webcast, demonstrating manufacturing ability was necessary or at least helpful to get NEO's IND approved. It was evidently quite the long shot, as AMGN though it'd be rejected (at least on the first try).
Whoops you're right, I misread (its early here). I thought it said AXAL-DUAL was being used in AIM2CERV, which I found very strange and/or illegal. I'll edit my post.
ADXS-DUAL likely targets both HPV-18 (which causes 50-60% of all cervical cancers) like AXAL does, and HPV-16 (10-12%). Its not a licensing deal so there's no money up front, but its still pretty big news. I wonder how many women with PRmCC have HPV-16 or HPV-18?
I think the lower-hanging fruit would be to get women with HPV types 16 and 18 (the sort which cause cancer) to vaccinate. Something like 3.4% of women in the US have these types of HPV, and its a lot more common in poorer countries.
We probably didn't have the data for the March 16th late-breaking data submission deadline. Its disappointing, but it hardly means the sky is falling.
If Dan came to believe his investment in Advaxis was misplaced he'd probably shift towards cash-based compensation and start selling shares ASAP. Accumulating shares of a dying company is literally the last thing anyone would want to do.
This is disappointing to say the least. From the corporate presentation in March, the company was planning on updating AIM2CERV, AXAL + durvalumab, phase 2 BrUOG anal cancer, Mt. Sinai phase 2 head and neck, and providing preliminary ADXS-HER2 data. Obviously we can't expect all abstracts to be accepted, but I was hoping for more than one, online-only.
Yup: http://iplanner.asco.org
You get a bunch of searchable poster sessions. However I can't find anything from Advaxis. Has anyone else had any luck?
There's a huge cofounding variable here. The reason many of the patients didn't get three doses was that they died.
A lot of people got burned by Cempra. I bet on Paratek partially because they have a SPA. Did CEMP have one as well?
Right, which is why I'd like to study the reasons for all late-stage cancer vaccine failures and see if they apply to AXAL. I'm not really sure where to start on this, so I emailed IR hoping they'd have some suggestion.
Do you think the failure of other cancer vaccines is relevant to AXAL? Provenge is the only one I'm aware of which has been approved.
I know a good bit about the bacterial side of things, but much less of immunology or oncology. I'm not even sure where to start when researching the causes of failure for the other vaccines and how they might relate to AXAL.
Employee stock options cannot be sold, so the vast majority of Dan's options are currently worthless. Black-Sholes doesn't work here.
Please let us know how it goes.
Its a common misconception that officers are required to increase the PPS. They aren't.
Officers have a fiduciary duty towards shareholders, and thats it. This means they're required to act in the shareholders best interests, but this may not be short-term increases in PPS. In fact they could be sued for providing a short-term increase at the expense of long-term value (or vise-versa).
The time value of money isn't nonsense. It's investing 101.
I agree a 0.25% increase by itself is negligible. However if markets expect a steady increase over the next few years you will see money move from equities to bonds.
I don't see why this would be a particular concern to ADXS though.
Interest rates affect the net present value (NPV) of all investments. They represent the returns on safe investments (treasury bonds). The lower they are, the more people put money into other things. Like the stock market.
[Advaxis will receive high single digit to mid-double digit royalty payments based on worldwide sales.]
Presumably Amgen keeps the rest.
http://ir.advaxis.com/press-releases/detail/1232
Amgen received around 85-92% of future revenue for that deal. Why would Dan give up so much future AXAL revenue, when its so much closer to marketability? He believes in the product.
NEO is much more complex and much more uncertain.
You're assuming a deal would include a lot of cash upfront. I'm not sure this will be the case.
I'm just a biotech novice, but bargaining isn't specific to this industry. When you have a situation where a manufacturer is more sure of a product's success than its seller, the seller is not inclined to pay much money upfront. The manufacturer would rather keep more future earnings than receive a too-small upfront payment by the seller.
Caveat venditor should apply here - let Advaxis beware.
Dan has displayed nothing if not a low time preference and confidence in AXAL. I don't believe he'll accept any more revenue dilution than is necessary to keep the lights on and trials running.
Meishairwin, I'd believe the market does a decent job at pricing ADXS if our market cap was higher than ADRO's. The fact that it's not means something has gone wrong IMO.
I'm not sure what that is. I'm open to the possibility that trading has created a self-fulfilling prophecy that ADXS never holds gains. I'm sure we've all seen and profited from stocks which are consistently traded below their fundamental value.
The recent PPS movement of UBNT comes to mind. It gets beat down even in the presence of heavy buybacks with a long history of being very well timed.
Pop-and-fade is simply too common in biotechs for me to take their PPS too seriously.
If you mean their chances of a successful NDA, its about the same. The authors of the study I linked to theorized it was because drugs with SPAs tended to be significantly more complex than ones without.
Incorrect, P2s do most of the culling. P3s have a 45% success rate.
http://www.nature.com/nbt/journal/v32/n1/full/nbt.2786.html
This is likely why we keep throwing research receptions. Its been my experience that researchers in the field are both ignorant of and actively hostile towards Lm technology.