Wow, just wow. After throwing out hundreds of millions of dollars, now they pull a plug on AXAL. Geesus!

FDA likely said "No way we are changing the protocol. Either keep it going or shut it down".

Now what?

Advaxis Announces Increasing Focus on Neoantigen-Directed Immunotherapies and Closing of Its Phase 3 AIM2CERV Study
PRINCETON, N.J.--(BUSINESS WIRE)--

https://finance.yahoo.com/news/advaxis-announces-increasing-focus-neoantigen-105000175.html

Advaxis, Inc. (ADXS), a clinical-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, today announced that it is increasing its focus on neoantigen-directed immunotherapies and closing the AIM2CERV Phase 3 clinical trial with axalimogene filolisbac (AXAL) in high-risk locally advanced cervical cancer. Advaxis intends to continue to support the clinical development of AXAL, its single-antigen construct, in other HPV-related cancers while redirecting resources towards advancing its neoantigen-directed programs. Specifically, the company plans to continue developing ADXS-NEO, currently in a Phase 1 clinical trial, in patients with several types of advanced or metastatic solid tumors including melanoma, lung, colorectal, head and neck and bladder cancers, and ADXS-HOT, currently in a Phase 1/2 clinical trial, for non-small cell lung cancer. The company anticipates advancing additional drug constructs from its ADXS-HOT program into the clinic over the next 18 months.

“We remain firmly committed to our Lm Technology™ platform, including our personalized and off-the-shelf approaches for neoantigen-directed therapies, and the development of AXAL against HPV-related cancers,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “While closing the AIM2CERV trial was a difficult decision due to the efforts of many individuals including the investigators and patients, the delays we incurred as a result of the recent FDA partial clinical hold and the estimated cost and time to completion for AIM2CERV led us to believe the best path forward for the company is to focus on our neoantigen programs. We believe this increased focus will enable a quicker and more cost-effective approach to demonstrate the strength and versatility of our Lm platform, thereby enhancing shareholder value.”

The estimated remaining cost to complete the AIM2CERV trial ranges from $80 million to $90 million, and initial efficacy data is not anticipated for at least three years. Therefore, results from the clinical trial were not the basis for the decision to close the study, nor was safety as the trial recently underwent its third Independent Data Monitoring Committee (IDMC) review with no safety issues noted. The company plans to unblind the AIM2CERV clinical data generated to date and anticipates submitting these data for publication. In addition, Advaxis will continue to pursue monetization opportunities for AXAL.

“The emerging data from our neoantigen programs look very promising, and therefore these programs merit an increased focus of the company’s resources,” stated Mr. Berlin. “With this redirection of resources to our neoantigen programs, we anticipate our cash usage for the next 12 months will be in the range of $33 million to $37 million, which includes $8 million to $9 million in non-recurring costs associated with prior AXAL studies including AIM2CERV. This reduction in our cash burn is a significant improvement over the past several years and also betters the goal we set of $45 million at the beginning of our fiscal year 2019.” He concluded, “We believe these changes will enable us to pursue a leadership position in the neoantigen field by building upon the early and exciting data from our ADXS-NEO and ADXS-HOT programs.”

About Advaxis, Inc.

Advaxis, Inc. is a clinical-stage biotechnology company focused on the discovery, development and commercialization of proprietary Lm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy and are designed to access and direct antigen presenting cells to stimulate anti-tumor T cell immunity, activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the tumor microenvironment to enable T cells to eliminate tumors. Advaxis has four programs in various stages of development: ADXS-NEO, a personalized neoantigen-directed therapy in principle for any solid tumor; ADXS-503 for non-small cell lung cancer, from its ADXS-HOT off-the-shelf neoantigen-directed program, ADXS-PSA for prostate cancer and ADXS-HPV for HPV-associated cancers.

Lottery ticket? Hardly so. Could a free one way ticket to a place where roads leading to that destination are paved with good intentions, e.g. to cure cancer. Ticket's are not refundable or transferable.

Have you been curious as to why Ken Berlin has been unable to strike anything of a substance? Well, I've been pondering for some time now puzzled by a total absence of any monetary deals in the past 3 years, and cannot shake away the notion that it's not Ken but the science. The clinical data has never produced a wow moment to turn heads of the science and medical community. The data has never been so convincing to pharmaceuticals and/or investment funds to jump and make a deal or take s take in the company. Thus, we have been in a free fall. Management missteps have just exacerbated the situation.
I'm sick and tired of their inability to remedy the dire situation. However, I've developed my 7th sense to identify companies like Advaxis and stay away from them regardless what others are saying.
Good luck to all of us.

Another implosion:
Note CNAT had a market cap of 30MM and voila ... Is Advaxis in better condition than theirs? Hardly.

Conatus to Explore Strategic Alternatives and Implement Restructuring Plan
https://finance.yahoo.com/news/conatus-explore-strategic-alternatives-implement-200600965.html

SAN DIEGO, June 24, 2019 (GLOBE NEWSWIRE) -- Conatus Pharmaceuticals Inc. (CNAT) today announced that the company has engaged Oppenheimer & Co., Inc., as its financial advisor to assist in the exploration and evaluation of strategic alternatives to enhance shareholder value. There can be no assurance of a successful outcome from these efforts, or of the form or timing of any such outcome. The company does not intend to make any further disclosures regarding the strategic review process unless and until a specific course of action is approved by the company’s Board of Directors.

In order to extend its resources, Conatus is implementing a restructuring plan that includes reducing staff by approximately 40% and suspending development of its inflammasome disease candidate, CTS-2090. The company has updated its financial guidance and is projecting a year-end 2019 net balance of cash, cash equivalents and marketable securities of between $10 million and $15 million.

“We remain excited by the potential of CTS-2090 as a uniquely positioned inflammasome disease compound,” said Steven J. Mento, Ph.D., President, Chief Executive Officer and co-founder of Conatus. “However, we must preserve our remaining resources to extend our cash runway to better explore strategic alternatives that can benefit shareholders. Although we are halting development activities for CTS-2090, we plan to continue to explore a variety of opportunities to advance this compound.”

Don't worry, Solly. The nightmare will soon be over. All the complains will disappear once the company disappears.
If you expect some other scenario, then please share it with us, mortals.

All time low of $2.08, or 0.138 pre-split. Just 60 cents from the bankruptcy. Inevitability Station is your next stop. Enjoy the ride into oblivion!

It's funny that they updated the corporate presentation the same day (rev-II) just to correct Dr Beto Petito's title to the Chair of Scientific Board on Page 33. Is he still on the management team though?
Would have been more informative if they put a timeline of Berlin's vacations and bonuses until it approaches a singularity point -- a bankruptcy.

From the company website:
“Advaxis Passion and Values

Our passion is to improve the lives of cancer patients and their loved ones.

We distinguish ourselves through Integrity, Accountability and Collaboration”
——————————-
I thought I had just enough of a beer ( sorry, not Sapporo, Batermere). Someone else must be smoking real cool stuff..

Fortunately, I am neither a cancer patient nor their lord one, so I figured Advaxis wouldn’t be improving my life

This would require a miracle on a scale of the College Road East that would send shockwaves through Princeton and level their educational center to the levels of of Eastern Montana State College of Hail Mary.

Can you inform us how much that would be pre-pre-split? Just curious I established a wrong position here early 2015?
Sincerely,
@wmtgreeter, a veteran of an Advaxis misery

I thought amoebas don’t have no brains. Was I wrong, Dr DDS?
Sincerely,
GEDholder

“that no news is good news??? “
———————————
That has not been the case for Advaxis for a long time. No news is always bad news as long as I remember.

I bet they haven’t had anything new to present. When was the last update? Less than a month ago? Does someone believe the company would come up with new data every month?
I expected them to start issuing fluff PRs around this time to attempt a secondary once the share price moves north. It hasn’t happened yet. I’m curious why they don’t follow their footsteps. Maybe, they have something else brewing? I hope so but history taught me a different lesson.

If there was any material information, they would have issued a press release.

However, Merck decided to keep that chump change and not to throw it at Advaxis. Why? Are they that stupid? Did they not read thousands of posts here by our advanced analytics about multi billion dollar potential?
It’s going to be really cheap for others to buy the remains of this company pretty soon. Fraction of a chump change would do.

Could be too little too late. Ken needs to pull out a rabbit out of his a$$. Someone wrapped that hat onto his rear.

They need to show a partial response for one or two patients. So far, it’s only a stable disease. That’s why the company wants a combo study which was not initially planned.

Of course, blame the FDA for all of the company’s problems. Why would not you ask DOC about a failure to include an interim look provision in the original SPA? Did they not know about that opportunity? To allow this trial to run for 5-6 years to get full data and not to be able to get an interim readout? How incompetent and short sighted.

Although it’s possible that the FDA approval for the interim look can provide some boost and is the showstopper for any AXAL deal, I doubt it is the reason for an absence of any monetary deals. They had lots of time to strike a deal and it has not happened. The reason could be as simple as there was no Ph 2 for the adjuvant settings. Now it’s a crapshoot for any pharma to pay for it. Well, they could have taken a stake in the company but why would they do that? Advaxis is on life support and they know it. Too much risk for unknown payoff. I don’t have to talk about the ISTs as they are virtually irrelevant to the direction of this company.

From WSJ:
“MRK is searching for small and midsize deals, including more transactions aimed at expanding its portfolio of cancer treatments beyond Keytruda.”
———————————-
So, question is: Does Merck consider Advaxis as a target for a deal?

K9 approval is not likely within 18 months. It takes time which Advaxis does not have. Someone else will be profiting from AT14, not Advaxis shareholders. C’est la vie!

Another 0.30 drop today?
The critical level to watch is 1.35-1.45 area. If we slice through that range, then we are to see a bankruptcy protection filing pretty soon. Since the company is quite and no fluff press releases, I don’t see another secondary here.

They keep shorting against the warrants until their expiration or until the company is out of business, whichever comes first. It’s no risk game, short-cover-short-cover. Many times a day, a week, a month. Not using the warrants. Lots of money could be made, and if the news hits, then they just cover with warrants. Plain and simple. Nothing can be worse, even having Ken Berlin to run this company.

As I can’t sleep, l need to say this loud and clear:
1) if Merck doesn’t want to pay for PSA combo, then Advaxis need to shut this trial down to preserve the capital;
2) they need to stop submitting INDs and starting new HOT trials for the same reasons as above;
3) they cannot afford to run Aim2cerv even after the FDA approves protocol modifications. See above;
4) NEO must be sold for whatever they can get. How difficult is that to comprehend?
5) ISTs are not an option at this stage of a total collapse. Stop talking with anyone who is not paying.
6) sell the manufacturing facility for anything.
7) cut the headcount even further, down to 25
8) sell HOT mon small cell lung cancer program for anything they can get.

He got more than half a million. Count 150 K for the first secondary and then add an annual bonus of up to 50% of his salary. Not too shabby for nothing to show for.

Wow. Another all time low. Spiraling down to drain

I had a nightmare last night. I was watching ADXS ticker on my screen, and it was green for a while. Then, just within few seconds , it suddenly turned red and plunged under 0.1 on enormous volume. What the hell happened? Did not get to know. I woke up in cold sweat and couldn’t fall asleep any more...
PS. It was one of those Mondays...

Updated corporate presentations:
New:
1) Significant Market Potential: Estimated over $500M market potential in cervical cancer alone, significant additional market potential associated with therapies for several different cancer types in development (NSCLC, CRC, Prostate, Head & Neck);
2) Is ADXS-HOT shown as Phase 2 trial? The arrow points towards Ph 2, not Ph 1, but it could be a screw up;

Short interest almost doubled between the last two reports:

Settlement Date Short Interest Avg Daily Share Volume Days To Cover
5/31/2019 370,091 152,267 2.430540
5/15/2019 211,141 395,382 1.000000

Thanks, Batermere.

Is it a joke or what: 103 shares traded in the first 25 minutes?

Since I've been relegated to the ranks of extremely poor from just poor's due to this investment, I will not be able to take a flight to KC and I'll need to hitchhike or just hike all the way down to Missouri. Anything is possible though.

It's always a problem when you negotiate from the position of weakness. Hard to bluff.

Well, the bad news is they are now down 33%. The good news is that they did not put much money.
I hope these purchases are profitable at some point so that my paper losses are not that unsurmountable.

You are correct. I completely forgot about those insignificant open market purchases two months ago by Molly and Roni.

Wednesday morning tidbit:
The stocks purchased in the open market by the management exactly one year ago are down by 91%. Not surprised we have not seen any more insider open market purchases since then. Why would anyone else buy this equity?

Interesting to note that 2 patients with metastatic colorectal cancer treated by NEO achieved stable disease (SD). This data must be compared with the Amgen/KRAS data for for the same indication. Looks like we are not doing worse than Amgen in this area. Let's see data for NSCLC patients. KRAS achieved PRs (5 out of 10).

KRAS: "The data in colorectal cancer were less promising. There were no partial responses here, and the best that Amgen could say was that 13 of 18 evaluable subjects achieved stable disease."
https://www.evaluate.com/vantage/articles/events/conferences/asco-2019-kras-chase-heats-amgen-data

They keep wasting precious resources, spreading themselves very thin. It's deja vu all over again: unable to focus on programs that are furthest ahead and have clinical data. All others should be put on hold until the cash issue is resolved if ever.

KB:" And in addition, I’d point out that, we have another asset that that’s early in development in the vet space, where we are utilizing the optimized construct that we’ve developed for HOT and NEO, where we put multiple antigens in there. And now we – we’re able to do that in the vet space like we did successfully with our HER2 construct that’s on the market today.

And so, we think there’s a nice monetization opportunity, very intriguing opportunity in the vet space to monetize through partnerships. We obviously have a partner today that’s getting acquired, so that would be the first place we would go to, to have a conversation. But just to point out that there are many different ways that we can monetize the science as we already have monetized HER2, both for vet use and for use in humans for pediatric osteosarcoma. And we’ll continue to look for ways to continue to monetize the platform, such as through the vet applications that I mentioned."