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I’ve not been following along as closely of late...
Does anyone have a sense for the sequence of events this week? Assuming a PR will come with the “new” information to be shared at the conference Wednesday afternoon.
G.B.
Interesting read on other cancer solutions being pursued.
This is on multiple newswires and various publications this morning. I’ve included the link from the Jerusalem Post since it has the full article. A little hard to follow due to all the ads and videos in the article text stream.
https://m.jpost.com/HEALTH-SCIENCE/A-cure-for-cancer-Israeli-scientists-say-they-think-they-found-one-578939
Seems way too optimistic, but reinforces the point a lot of researchers are pursuing immunotherapy based answers.
G.B.
“What exactly is the company trying to indicate with this announcement?”
According to the announcement text they have “new” information to share. I’m curious and anxious to hear what’s new.
“Overview of the Company’s proprietary Lm platform and new information regarding the Company’s neoantigen-directed therapy programs, ADXS-NEO (customized, personalized neoantigens) and ADXS-HOT (off-the-shelf, hotspot or shared neoantigens and other antigens), will be presented”
They haven’t historically announced big news at conferences but something meaningful and material would be good.
G.B.
MKiP is correct. I recall Dr. Mason intended to target dogs who hadn’t experienced amputation and in fact she may have successfully treated a few dogs in her earlier trials who had not had limbs removed. I also recall her stressing the leap from treating canines to children being a logical and needed next step.
Osteosarcoma in adolescents isn’t statistically a big population (not a profitable bet) and treatment is still via traditional chemo and radiation. ADXS had a juvinile osteosarcoma trial on their docket at one time but it was shelved or delayed as they began to experience financial distress.
JMO - Dr Mason is fully aware of goings on at ADXS and PETX and how their motives likely differ from hers. I think she has her own research resources via UPENN, is respected within important medical circles and is on a mission to advance medical science she clearly believes in. How refreshing.
G.B.
Interesting UPENN’s Dr Mason continues to push ahead with her own work utilizing HER2 to treat canine osteosarcoma. She announced a planned 80 dog trial in June 2017 coordinated with NCI and sponsored via a $1M grant from Morris Animal Foundation. She stressed at the time of the announcement a parallel goal of promoting HER2 to treat juvenile osteosarcoma since the disease is indistinguishable in dogs and children.
Reading between the lines she obviously feels HER2 is an Lm medical construct worthy of development. It’s also interesting her continuing efforts with HER2 and expanded canine trials seem to compete with PETX AT-014 efforts.
In addition to UPENN, who is conducting part of the 80 dog trials, they’ve enlisted partner schools to assist with the trials as reflected in the attached links. Tufts and K-State are reflected as recruitment sites. There may be others I didn’t find in researching the initiative.
https://www.vet.k-state.edu/vhc/services/clinical-trials/ListeriaVaccineCanineOsteosarcoma.html
https://trials.vet.tufts.edu/clinical_trials/a-vaccine-therapy-for-treatment-of-dogs-with-osteosarcoma-bone-cancer/
I can’t imagine the patience required or the frustration endured by researchers like Dr. Mason who’s original breakthrough work with HER2 that doubled, and in some cases more than tripled, life expectancy of dogs diagnosed with osteosarcoma is now 6-7 years old. Her original sample was small. Her 80 canine initiative is likely her effort to prove a point.
G.B.
Merck...
Has $10.3B in cash and short term investment liquidity burning a hole in their pocket. ADXS constructs could be a small but interesting addition for them.
G.B.
I was burned out from exhaustion, buried in the hail
poisoned in the bushes an' blown out on the trail
hunted like a crocodile, ravaged in the corn...
Come in, she said I'll give ya,
shelter from the storm.
Credit - Bob Dylan
He clearly held ADXS stock at some point.
G.B.
To paraphrase Woody Allen...
"More than any other time in history, (ADXS) faces a crossroads. One path leads to despair and utter hopelessness. The other, to total extinction. Let us pray they have the wisdom to choose correctly."
If a RS to avoid delisting and further “bend over” dilution is to be avoided the company must produce something fairly profound in the short time that remains before those actions become a hard requirement. So far, the market seems to know what’s coming.
G.B.
Livinginawesometown... Appreciate your countervailing rationale and in a world where small shareholders voices mattered and there was a scintilla of trust in management, more of us would be willing to give ADXS leadership the benefit of the doubt. Some context may be in order.
In all the years I’ve held the stock, not one proxy proposal has been defeated, management has won every vote on every proposal. The only time it was even close, Dan O’Conner was pushing through an obscene increase in executive compensation in 2014 / 2015. After getting lots of investor blowback he simply held up the proposal, issued more shares and won the vote by overwhelming old shareholders with votes from new ones. His “all in” compensation the following year jumped to $15M.
The current precarious state of the enterprise is certainly not due to activist small investors denying leadership from getting everything they’ve ask for to run the company.
The irritation expressed on this MB, and the defiant “no” votes including mine, are purely symbolic. We ankle biters have yet to win a proxy battle and we all know we’re not going to win the current one. The outcome is predetermined.
G.B.
They work all the angles to insure the vote goes their way.
Unless I’m misreading the intent...
Proposals that begin with, “To consider and act upon an advisory (non-binding) vote” sounds like, thanks for expressing your wishes. We’ll take the input under advisement and since it’s non-binding, do exactly what we want.
Kinda like their plurality vote counting method that guarantees the BOD gets re-elected for life.
These annual cluster @*&$ operations are a sham and a waste of money they don’t have. I followed the prescribed voting pattern like it makes any difference.
G.B.
While none of us are privy to any of the term sheet discussions or specifics there will the usual leaks to the usual suspects. The behavior of the SP over the next month or so will be be informative.
While many assume the RS is a forgone conclusion I’m foolishly hoping they’re still working hard to avoid the nuclear option. I had 400,000 shares when they triggered the 125 for 1 split. I knew they had one billion shares authorized and would do a RS to get listed on the NASDAQ, but 125-1 seemed excessive at the time.
To quote General Patton... “I never want to pay for the same ground twice...”.
I certainly don’t intend to pay for shares three times.
G.B.
A slightly different take on debating term sheet semantics?
The fact they’re talking to one or more 3rd parties about “terms”, in just about any context, is one of the more positive things I’ve heard in a long time. Also the fact they were confidant enough to publicly disclose discussions are occurring involving terms of transactions or agreements isn’t trivial.
Most important is where they stand on actions to avoid looming financial maneuvering that will further diminish interests of current investors.
G.B.
Several long time posters have suggested tomorrow will not bring anything new or meaningful to light as it doesn’t fit the companies pattern of releasing news.
If tomorrow is another nothing-burger, I think it will be time to consider the difficult prospect that something is seriously amiss with the Lm platform. Yes, there haven’t been any major trial misses or outright failures but after a number of BP’s have kicked the tires, none have made a serious commitment and some have simply walked away and moved on.
Lm may yet find a medical niche to fill but dreams of it being a big impact medical game changer are quickly becoming harder to defend based on all the cumulative evidence at hand. A tough reality to accept if thats what’s unfolding.
G.B.
He said “stay tuned”. Not much to pin our hopes on, but either way, I think we’ll know tomorrow. The message has to be more material than we have various deliverables coming in ‘19.
G.B.
At some point it would be nice to hear what Berlin meant when he said “stay tuned” implying there’s something to “stay tuned” for beyond his need to say something so he could get off the phone call.
Hard to see how it does anyone any good, particularly ADXS, if the Tuesday CC is a stale rehash of what little we already know. I hope that’s not the case as it will make it unsafe to be standing anywhere near the exits after the call.
G.B.
Perhaps there is an entity who is able to look past the ineptness of the multiple trustees who have mismanaged the development and delivery of the Lm platform and see the medical potential. I’d enjoy seeing the science in new hands who have deep pockets, research depth and the skill to advance Lm medical science. It’s time for ADXS to wink out of existence.
G.B.
Probably our best shot, gold... Whatever data they can produce in the aggregate from multiple initiatives may be sufficient to induce a lowball offer from a second tier Pharma who’s willing to take a flyer on Lm. Early data on anal, head and neck and prostate appeared compelling enough to garner outside interests.
Perhaps the science survives within another company, changes hands a couple of times and re-emerges in the future as part of a combo cocktail construct.
At this point, most of us would welcome that outcome.
G.B.
I’d love to think inattention to website maintenance is because they know there won’t be any need for an ADXS website once they’re acquired in the near term. The alternative is to assume they’re just sloppy, disorganized and scrambling to hold things together, therefore website currancy and public image is the least of their worries.
Hopefully it’s the first option.
G.B.
As a couple of us wildly speculated 3-4 days ago... A stretch but... Filing the toxic proxy as a Plan B contingency placeholder would be necessary in the event a more favorable outcome (a pending partnership or similar game changer) isn’t achieved near term.
In any event, nice to see green on the board today.
G.B.
A stretch is the negative provisions in the proxy are Plan B placeholders that have to be established and communicated now in the event Plan A negotiations come up empty.
Like I said... It’s a foolish stretch but, it’s about all we have.
G.B.
Plenty of disappointment to go around heightened by the general feeling the science has been mismanaged and poorly represented. Can’t blame anyone who’s sold based on a two year accelerated downward spiral. Fully appreciate why they’re disappointed.
Also can’t blame those of us who continue to hold hoping for an intervention that salvages the medical promise of the science. Some of us will hang on until it goes to zero rather than sell. We’re dumb, stubborn or both and while a very long shot, perhaps lucky in the end.
I’m just hoping Dr. Paterson’s Lm platform somehow survives the failed regime in Princeton and lands in more capable hands.
G.B.
Hard to fathom small investors, who now have majority control, supporting a proxy that just brings more pain unless ADXS leadership can provide a very compelling reason to do so.
Berlin has to know angry investors are getting organized in the back of the plane, in reaction to the proxy, with every intention of breaking through the cockpit door.
One way or another the science is likely destined to end up in new hands. It’s hard to believe it would be worse off with different stewardship.
A word about the BOD. They’re largely disinterested at this point. They’re insured against legal liability and all have multiple other BOD gigs. ADXS is a small fraction of their portfolios.
G.B.
Small biotechs are required to fight like hell to survive. The deck is heavily stacked against their success between FDA barriers that take years and tens of millions of dollars to overcome, unchecked market forces who savage the SP with impunity and unethical BP’s who run brutal beauty contest to determine if a small startup company can provide value worthy of partnerships and investment.
The combination of these risk factors likely results in outsized compensation packages and animates the general greedy behavior of small biotech company leaders who grab all the cash they can, while they can, because any success is likely years away if it happens at all. It feels like there something terribly wrong with the illogical and plainly idiotic process we employee to advance medical science.
Just scanned the NWBO IHUB MB. Multiple dilutions resulting in 500M outstanding shares but the diehard believers are saying 2019 will be the year they breakout. Has a familiar ring.
G.B.
it’s increasingly clear they feel the development listed in the 8K is all the information they are required to disclose. Investors are left twisting in the wind without any signal more news will be forthcoming.
The silence speaks volumes.
G.B.
“Still nothing from the company” A week after AMGN served notice.
Could be time for the white coats to pounce on the janitor and dose his butt with HOT so they can honor a commitment and say something positive.
“ADXS announces first patient dosed with HOT...although somewhat reluctantly”
Still holding...
G.B.
“It could be that they're giving you guys time (to unload) shares???”
That briefly occurred to me as well but I doubt they’re that considerate. Not sure what’s supporting it at the current levels with no explanation being offered. With no official reaction they’re essentially letting the 8-K speak for them.
Your only source of material non-dilutive funding just quit the partnership. Are people jumping off the one story building in Princeton or is there a rationale explanation for the sudden change in direction?
Bueller? Bueller?
G.B.
AMGN actions seem perfunctory and extreme. Not something they would do unless provoked or convinced it was in their best interests to sever the relationship. Like to think they were concerned HOT will be broadly effective out of the box and will undercut their investment in NEO. Admittedly grasping at straws at this point.
We’re owed an explanation.
G.B.
Agree... Great read oakrock.
Lm as an efficacious mono therapy and performance boosting additive for multiple other medical compounds is our future.
G.B.
Good job capturing additional key data points from KB presentation. I feel more optimistic following the webcast.
I believe the institutions who are still hanging around are doing so for the same reason we small retail ankle biters are. They, like many of us, are willing to take the risk and bet the science will be highly valued at some point.
G.B.
“Actually, the sentiment seemed broader, that Axal on the whole had a "high probability of technical and regulatory success," and indicated that this was across all the indications.”
Good point that just zipped by in the presentation. He also acknowledged some of the early notable outcomes from select constructs were based on small samples but I expect there’s a strong belief within ADXS the positive results will extend to larger patient samples.
G.B.
KB did a decent job. Obviously time constrained to cover as much ground as possible. Things I noted....
Clear the effort to get an early peak at AXAL data is intended to entice a partner who would assume ongoing trial costs. Referred to AXAL as a stage III asset.
First HOT patient to be dosed in the next few weeks.
Referenced canine osteosarcoma construct as commercially available via an unnamed partner.
Key data readouts during the first half of ‘19 would appear to have make or break implications.
Obviously got hit with a couple of tough financial status questions at the end. Mentioned the efforts to reduce cash burn. Also indicated lots of small biotechs are trading at cash or lower and suggested ADXS was painted with a broad brush across the sector that was prompted by select trial failures by other small immunotherapy companies.
I’m sure others picked up on more info in the quick overview than I did.
G.B.
Same feeling. Lm as an essential ingredient, improving effectiveness of multiple medical constructs, would be a great outcome.
“Dr Patterson's $100K is probably worth $1000 now.”
Tragic for sure... Unlike many of us, perhaps she pulled the ripcord on the way down.
G.B.
I also added a couple thousand shares this morning... At the current SP it’s difficult not to keep buying if you have faith in the science. Sure, big risk but with very large upside potential.
G.B.
In the meantime, back at the Aratana ranch...
Response to my query on the possibility of a progress report on AT-014 at 24 active sites based on USDA conditional approval.
“Thanks for your email. As you stated, Canine Osteosarcoma Vaccine (AT-014) is available at approximately two dozen veterinary oncology practice groups participating in an extended field study across the United States. We did state in our third quarter 10-Q document that study sites are enrolling dogs, however we have not provided any further progress updates on the study.”
Watching paint dry...
G.B.
“ADXS is in the toilet because mgt burned $200m of investor capital and came up with zero in terms of a revenue generating product or partnership.”
I tend to agree... I also suspect going back to Dan’s tenure they assumed they had multiple partnership agreements in the bag that didn’t close for whatever reason. Tough to rationalize the spending and hiring binges unless they were convinced new cash infusions we’re going to occur. The alternative is to assume they were idiots, but I digress.
G.B.
The Event Horizon a.k.a. the point of no return. I hope ADXS leadership fully appreciates the physics of a financial black hole.
G.B.
I suppose in a perverse way of thinking it’s better they covet more equity with a big upside vs just increases in raw dollars via base pay.
G.B.
Shares were sold to cover taxes on the entire grant that vested. Common practice with restricted stock awards.
G.B.
As mentioned, I think we’re still in the long game... Lm with its safety and low cost to produce profile can emerge as a universal co-hort or additive to boost a host of existing and emerging treatments.
https://www.theguardian.com/science/2018/nov/04/a-cure-for-cancer-how-to-kill-a-killer-revolutionary-immune-system-immunotherapy
G.B.