Replies to post #77936 on Ayala Pharmaceuticals Inc (fka ADXS)

[maplestory]

Question is how much time do we have until deal or buyout?

[ubmmg]

withdrawal of the EMA

An EMA application and a subsequent withdrawal highlighted two major issues with Advaxis:
1) The misdirection of the company, a failure to identify the priorities, and failure to adequately assess the risks associated with the approval process: The management should have known the data for an EU approval was not sufficient and they should never have spent any resources to file for EMA approval. This is solely on the management.
2) A corollary from the Item 1: spending issues. They have spend too much money and human hours to prepare and file the EU application. All in vain.
Pathetic management, and pathetic outcome for the shareholders.

[cdiddy01]

What makes that even more alarming was that most people with an understanding of the filing only saw it as an extreme longshot to begin with. Reading this board you would have thought it was a shoe in. Little did I realize, it would have been unprecedented had they actually approved it given the limited dataset. The amount of money they spent and the situation we're now in hinged on (hate this term) a Hail Mary.

Agree on the two options at this point, however unfortunate it may be. I'm still hopeful HOT is worth what they think it is...

[jckrdu]

"It is clear that the only two options are either significant licensing deals or a buyout."
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They'll license HOT indications at some point, but it may not be immediately.

IMO, the fact that they hired a new CFO and finally filled the vacant CMO position (after years of being vacant?) means that a buyout isn't likely near-term, and Ken is executing a longer term gameplan to build shareholder value with the new management team in place.

HOT constructs will be worth much more once they have some preliminary NEO data to validate platform. Ken may be concluding that - in the longterm - it makes more sense to license later from a position of strength with data - and therefore plan may be to raise a modest amount of cash now using a portion of the 30M shares, after some good news is released (Head & Neck IST start.)

A lot hinges on path forward for AXAL/Cervical. If AXAL/Cervical is wound-down (most likely scenario IMO) market will want to see $50M annual burn-rate reduced to something closer to $30M or $40M, because a $50M burn for an early Phase 1 company (without AXAL/Cervical) is too high.

We'll see how it unfolds. Should get the gameplan in Sept call.

GLTA.

[rmarc]

"It is clear that the only two options are either significant licensing deals or a buyout. The withdrawal of the EMA made this even more apparent." ... I posted many times that AXAL will not get FDA or EU approval. The third option that you neglected to post is the most likely option. No buyout, No big upfront cash licensing deals. Con man Ken Berlin will foist big time mass dilution onto ADXS shareholders with a new funding that includes another monster reverse split to keep this rotting corpse alive.