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Thanks, Ken, for your hard work!
I understand you decided to release this announcement just after the Labor Day when folks are back to work.
Still waiting to hear from you about AXAL/cervical program.
"Under the terms of the license agreement, OS Therapies, in collaboration with the Children’s Oncology Group (COG)1, will be responsible for the conduct and funding of a clinical study evaluating ADXS-HER2 in recurrent, completely resected osteosarcoma. Advaxis will receive an upfront payment, reimbursement for product supply and other support, clinical, regulatory, and sales-based milestone payments, and royalties on future product sales. Additional details of the financial terms have not been disclosed."
Advaxis Licenses ADXS-HER2 To OS Therapies For Evaluation In The Treatment Of Osteosarcoma
September 4, 2018
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"Advaxis is pleased to license ADXS-HER2 to OS Therapies for human clinical trials in osteosarcoma. ADXS-HER2, which is already approved in the U.S. for the adjuvant treatment of osteosarcoma in canines, has the potential to provide a new treatment option for human osteosarcoma patients"
PRINCETON, N.J. and FAIRFAX, Va.--(BUSINESS WIRE)--Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, and OS Therapies LLC, a clinical-stage therapeutic company focused on the identification, development and commercialization of treatments for osteosarcoma, today announced that Advaxis has granted a license to OS Therapies for the use of ADXS31-164, also known as ADXS-HER2, for evaluation in the treatment of osteosarcoma in humans.
Osteosarcoma is an aggressive cancerous tumor that forms in bone. Although it is rare, osteosarcoma is the most common type of bone cancer, and is most frequently found in children and young adults. Current treatment options are limited and there have been no new treatment options in more than thirty years.
Under the terms of the license agreement, OS Therapies, in collaboration with the Children’s Oncology Group (COG)1, will be responsible for the conduct and funding of a clinical study evaluating ADXS-HER2 in recurrent, completely resected osteosarcoma. Advaxis will receive an upfront payment, reimbursement for product supply and other support, clinical, regulatory, and sales-based milestone payments, and royalties on future product sales. Additional details of the financial terms have not been disclosed.
“Advaxis is pleased to license ADXS-HER2 to OS Therapies for human clinical trials in osteosarcoma. ADXS-HER2, which is already approved in the U.S. for the adjuvant treatment of osteosarcoma in canines, has the potential to provide a new treatment option for human osteosarcoma patients,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “As Advaxis is primarily focused on developing neoantigen-directed therapeutics, this license agreement will allow for the clinical potential of ADXS-HER2 to be explored in osteosarcoma without financial support from Advaxis, building on earlier work performed by us with ADXS-HER2 in a Phase 1 clinical trial.”
“The OS Therapies mission is to develop and commercialize new therapeutics for the treatment of osteosarcoma, a deadly and extremely underserved pediatric cancer. We are excited about the opportunity to evaluate ADXS-HER2 in this indication, as its clinical profile has shown promise to date,” said Paul Romness, Chief Executive Officer of OS Therapies. “Our initial focus is on the most common genetic mutation found in osteosarcoma, and we believe that HER2, and more specifically ADXS-HER2, holds potential to impact the treatment paradigm.”
1 The Children’s Oncology Group (www.childrensoncologygroup.org), a member of the NCI National Clinical Trials Network (NCTN), is the world’s largest organization devoted exclusively to childhood and adolescent cancer research with over 10,000 experts worldwide working in over 200 COG member institutions. COG’s mission is to improve the cure rate and outcome for all children with cancer.
About OS Therapies
OS Therapies was founded by concerned parents and friends of children with osteosarcoma, and is innovatively funded by public, non-profit, and private funding. OS Therapies CEO Paul Romness, formerly of Johnson & Johnson, Amgen and Boehringer Ingelheim, has brought together a group of industry veterans including Cerecor CEO Peter Greenleaf, as well as an internationally recognized Osteosarcoma Scientific Advisory Board.
To learn more about OS Therapies, visit www.ostherapies.com.
About Advaxis, Inc.
Advaxis, Inc. is a late-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 the T cells to eliminate tumors. Advaxis has four franchises in various stages of clinical and preclinical development: HPV-associated cancers, neoantigen therapy, hotspot/ cancer antigens and prostate cancer.
To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube.
Advaxis Forward-Looking Statement
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The factors that could cause our actual results to differ materially include: the success and timing of our clinical trials, including patient accrual; our ability to release the clinical hold and reduce the impact to our trials; our ability to obtain and maintain regulatory approval and/or reimbursement of our product candidates for marketing; our ability to obtain the appropriate labeling of our products under any regulatory approval; our plans to develop and commercialize our products; the successful development and implementation of our sales and marketing campaigns; the size and growth of the potential markets for our product candidates and our ability to serve those markets; our ability to successfully compete in the potential markets for our product candidates, if commercialized; regulatory developments in the United States and other countries; the rate and degree of market acceptance of any of our product candidates; new products, product candidates or new uses for existing products or technologies introduced or announced by our competitors and the timing of these introductions or announcements; market conditions in the pharmaceutical and biotechnology sectors; our available cash; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; our ability to obtain additional funding; our ability to obtain and maintain intellectual property protection for our product candidates; the success and timing of our preclinical studies including IND-enabling studies; the timing of our IND submissions, the ability of our product candidates to successfully perform in clinical trials; our ability to execute clinical trials; our ability to maintain collaborations; our ability to initiate pilot studies and clinical trials, enroll our trials, obtain and maintain approval of our product candidates; our ability to manufacture and the performance of third-party manufacturers; the performance of our clinical research organizations, clinical trial sponsors and clinical trial investigators; our ability to successfully implement our strategy; and other risk factors identified from time to time in our reports filed with the SEC. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
CONTACT:
Investors:
LHA Investor Relations
Miriam Weber Miller, 212-838-3777
mmiller@lhai.com
or
Advaxis, Inc.
Ranya Dajani, 609-250-7559
dajani@advaxis.com
or
OS Therapies
Paul Romness, 703-541-9811
par@ostherapies.com
The only change I see is that ADXS-PSA, Part-B, Monotherapy is now dropped from the August presentation.
Nothing else.
That statement was on August '18 presentation, not on July presentation, however.
There is always hope.
——————————
Also a prayer. Those two are all we have left right now.
#hopeandchange
Mr Zhang,
You still have have time to own a few shares then. Do it, before it’s too late.
#nopassaran
Are we sold yet? I’ve been away from this board for 45 hrs and 23 minutes. Please update. Eager to hear anything positive.
@wmtgreeter
I think you'll be singing hosannas until KB starts grabbing larger pieces of the pie via RSUs.
Ken got 250,000 RSUs immediately after he got the job. Then, he made an open market purchase of 15,000 shares at $1.84. Is that a lot? Not really, given his compensation. He can afford losing it all if he stays at the helm for over a year. He would not be greeting folks at the Walmart stores, trust me.
Right now, we are yet to see how greedy he is. His greed may eclipse that of O'Connor's, as he was not a Semper Fi. You may get another talking point then.
DawsonMcKay:
It's not about patience or impatience anymore. It's about a strong possibility of wiping out the legacy shareholders. In an absence of a clear path forward that outlines a minimal dilution at these lowest share prices, the markets assume the shelf would be used at some point to raise money if no cash deals are completed. If that were to happen, my original investment would be down not by 90 something percent, but 99+ percent which is technically a write off. The only beneficiaries if the science works out would be new investors.
PS. Don't suggest about averaging down.
Where's the deal, Ken?
Were you saying Friday after the close news?
DOC was shrouded with a veil of nepotism when he was running Advaxis.
Did that change when he moved to Oncosec? No, does not look that way. For example, the investors relations company they employ is Stern Investor Relations, located in NYC. Guess who signs all PRs issued by ONCS? Will O'Connor, associate at SternIR. Any relation with DOC? Just a son. Why not? Any norms and ethics are thrown out of windows. Capitalism, nothing personal...
Warrants were trading about $1 seven months ago. They traded at 0.025 at some point few days ago, and now getting back to 0.14. It's possible that someone accumulating cheap options (not clear why, and less likely), or more likely, trying to attract traders or reignite the interest of the current warrant holders to sell into the strength. Someone's trying to get out of the warrants?
Date Open High Low Close / Last Volume
14:37 0.08 0.14 0.14 0.14 300
08/29/2018 0.05 0.08 0.05 0.0799 9,610
08/28/2018 0.08 0.08 0.05 0.05 13,798
08/27/2018 0.06 0.0683 0.06 0.0683 15,022
08/24/2018 0.06 0.06 0.06 0.06 283
08/23/2018 0.051 0.0512 0.051 0.0512 600
08/22/2018 0.0562 0.0562 0.0562 0.0562 800
08/21/2018 0.065 0.065 0.065 0.065 00
08/20/2018 0.05 0.065 0.05 0.065 1,000
08/17/2018 0.05 0.05 0.05 0.05 300
08/16/2018 0.06 0.06 0.06 0.06 00
08/15/2018 0.09 0.09 0.05 0.06 6,000
08/14/2018 0.08 0.08 0.078 0.08 7,671
08/13/2018 0.05 0.05 0.05 0.05 100
08/10/2018 0.08 0.08 0.08 0.08 00
08/09/2018 0.075 0.08 0.0258 0.08 13,698
08/08/2018 0.08 0.0901 0.08 0.0901 4,163
08/07/2018 0.0975 0.1267 0.0975 0.12 663
08/06/2018 0.0848 0.145 0.075 0.075 17,882
I hope so, and also hope it's not after the reverse split, LOL!
Batermere, we need to stop predicting the future and make those outrages prognostications. So far, how many great prognostications came in true? None! Only doom and gloom predictions were correct. What makes you think this time is going to be different?
The only major difference (besides that obvious HOT partnership blunder) between July and August presentations is Slide 4, "Pathway to Creating Shareholder Value":
"?
Company focus shifted to higher value assets; streamlining the HPV program
?Seeking partner for ADXS-HPV (AXAL) in cervical cancer in the U.S. and Europe
?Discussing IST opportunity for AXAL in HPV + head-and-neck cancer
So, they seem to be still talking about AXAL and partnerships. Why else they put this slide now to emphasize AXAL?
I'm pretty much sure it's an error. Someone might have copied the previous slide without deletion of the NEO slide (page 12).
That's the level of attention to details at ADXS.
Remember, they had a link to EMA submission on their web page two months after they pulled a plug on it. They removed it after I complained.
The fight of the century, 9/11/18, 8am Eastern:
KB vs BK
Payper view, for real shareholders only.
You also have to account for the following:
The history of secondary offerings for the companies stuck like ADXS (MC<=$80M, perennial under-performance, history of bad deals, and etc) shows that these companies are forced into extremely unfavorable terms: shares discounted at 30% on average AND warrants (sometimes double warrants) attached to the offering. The exercise prices are such that the cost basis for the "new" predatory hedge funds is much lower than the offering price. Thus, the share price drops much more than the secondary offering price. Google those cases, and you'd be shocked to see the consequences. I'm most afraid of those combo types of offerings as these are a millstone around the company's neck.
Amgen got a steal of a lifetime when they inked a NEO deal two years ago. Of course, if and only if the platform works as advertised. They basically purchased extremely cheap long-term options which allows them to own an entire platform. Yes, there's a potential threat from HOT in the future, but I believe Amgen will make more than enough money before HOT gets into the market and, of course, it works.
Another validation of the thesis that NEO got sold at a very small fraction of its potential price was Affimed's deal. This is what Advaxis should have gotten, at least. I'm not talking about upfront cash, but the potential price of the deal.
There's no way Amgen can be forced to re-negotiate the 2016 deal. What's done is done, and it's solely on DOC. Now let's see what the current management could do with what's they left with -- HOT.
Let me say it again: extension of warrants would be a bearish event.
Depending on for the length of the extension, the shorts would use that time frame as a safe window to attack the stock knowing the management doesn’t expect any major news for the major period of that time frame.
On the other hand, if the warrants are also repriced (lowered) in addition to an extension, that would be a golden for those who control the share price and its direction. We all will suffer from the exhausting short attack during at least first half of that extension.
I do not have any warrants, and would be happy to see those warrants expire worthless. Folks had too much time for them to exercise and they did not. Too bad.
Great observations, kgb03.14!
With your unique dot connecting skills, we are rapidly moving ahead towards an ultimate buyout. It would be helpful to add another similarity between AFMD and ADXS -- remember an AXAL submission for a conditional approval in EU? I am sure that ADXS pulled that application not because they had incomplete data, but because Roche's Genentech decided to postpone that approval until after the buyout. There were threatened by the slam dunk possibility of approval of AXAL for cervical cancer in Europe threatening their core business model. Thus, one of the most powerful EU pharmas decided to force Advaxis for a temporary withdrawal so that they have sufficient time to accumulate shares. The puzzle is almost solved!
Add to this theory (almost validated though!) that Advaxis filed another Form-3 and removed ATM clause from it. Also, Ken did not even bother to create his new ADXS twitter account knowing very well that they would be bought out. All pieces of this huge puzzle now started to fit into a big, nice picture. What do I see on it? A $5,125,793,486.12 check written by Roche.
@wmtgreeter
Three more days to ink a deal, Ken! Keep your promise, and deliver by the Labor Day. Sell the Beech!
Ken, you need to be aware that due to your inaction, too many here on this message board get more and more emotionally disturbed and lose their blue heads. You do not want to be remembered as a CEO who orchestrated an infamous event known as an Advaxis massacre.
#hertoo!
We need to start #her2 or #hertoo compaign!
#HERTOO
KB could sell ice to Eskimos.
PS. too many Canadians here and if that’s offensive to our liberal friends, I’m sorry. Not a PC type, per se.
Pays to be a masochist?
Let me rephrase it:
2b||!2b that is the question.
@wmtgreeter
It doesn’t matter what I think. What matters what Ken said yesterday: partnership will be announced this week. Not too long to wait. Try to be optimistic and prepare yourself for a great future! It’s just behind the corner, according to one of the most vicious dog breed.
Hibernation would be more acceptable word by a PC crowd.
Sleeping giant.
Pretty quiet day on the Western front today. Where are the foot solders of the hedge funds? Pink slips flying all over Stamford, CT?
Bashers disappeared. Does it signal an imminent buyout?
It’s nothing but wishful thinking. Pure conjecture. Ramp up the expectations during the weekend to then face a harsh reality later when the markets are actually open.
Everyone has been waiting for some kind of positive development for too long. Some start experiencing hallucinations when the patience wears out.
Nah, the shares will get partnered with the warrants and then sold. Partnership first, sale next.
Again, thanks, Ken for the heads up about the news.
Thanks, Ken.
I hope the judge rejects a plea bargain deal that sends Dan O’Connor to jail for 5 years only. He deserves 15 years of electric chair and 2 lethal injections in between for colluding with the high frequency traders and algos.
Listeria lives also matter!
Very slim, but it doesn’t matter. The legacy shareholders would be feeling the same effect of bankruptcy once the dilution mechanism kicks in. Some are already down as much as 95% on their original investment. It would not take multiple dilutions to be completely wiped out. The company would survive and the management would get paid but we would be left in the dust. Of course, the positivists will say to keep averaging down but throwing good money after bad is not my thing.
Yes, I need to confess. I made a mistake by putting $451.83, my entire life savings, into this stock.
I sure hope to expropriate what was expropriated from me by the scammers. My day will come, and I’ll be visiting Walmart stores as a customer, not an employee.
You are trying to find a black cat in a dark room where there is no cat.
Too convoluted a theory for me, a GED holder with the IQ barely exceeding the ocean water freezing temperature, to even understand that scenario. Too much credit for me, a poor @wmtgreeteer, whereas I deserve none.
Canceling ATM means one and only one thing — the buyout is very near. Remember the company went into a complete radio silence mode this past spring? It was done to prepare for a huge buyout. It was the last rehearsal before this imminent buyout this autumn! Pulling ATM definitely implies the company does not need money anymore as the $5.793B cash windfall is about to descend from the Blue skies!
Those statements have been made behind the safety firewall of the “safe harbor statements”. In reality, they mean virtually nothing, just a boilerplate phrases to cover their a$$es. Never put too much weight on what they say or assume in these filings.
Good science may not be good enough to attract new investors especially when legacy holders bail out. The science has to be great, a real cutting edge science to make this equity attractive again. The area is now crowded and Advaxis’ AXAL is no longer unique as it was few years ago. The landscape keeps changing at a very fast pace. DOC failed to capitalize on AXAL platform when it was hot and unique and promising. That train has already left the station. Time is money. Time wasted is the money wasted.
I fail to understand how you can spin this shelf refiling as a positive?
Traders playing this shelf event? Yes, of course, you might be right, but did you notice huge blocks got dumped yesterday afternoon? Those blocks were not traders, but funds dumping. Someone got out yesterday seeing this shelf as a precursor to a more dilution.