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Ken:"It's a pretty cheap entry point today".
Anyone buying?
Something is not right about Aim2Cerv enrollment.
August '17 presentation: 2018/Q4 -- last patient enrolled, 2H/2020 -- study completed;
March '18 presentation: Data expected 2020/2021;
From clinicaltrials.gov: Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021;
Primary Outcome Measures :
Disease free survival (DFS) [ Time Frame: 5 Years ]
Secondary Outcome Measures :
Safety & tolerability Overall survival (OS) [ Time Frame: 5 Years ]
From today's PR: "“The redesign of AIM2CERV with an earlier interim analysis would allow us to alter course or, if necessary, stop the study, depending on the results. If the FDA accepts our proposed revisions, we anticipate having a recommendation based on the interim analysis from the data monitoring committee as early as the fourth quarter of 2020.”
So, what exactly do they want FDA to change? Enrollment should have been completed pretty much by this time. Slow enrollment? Do they want to reduce the time frames from 5 years down to 2 or 3 years? First patient was enrolled in Q1/2017. Time frame for 3 years would make sense for interim readout if they enrolled 100-150 patients in 2017. Hov, please chime in.
Whatever is said on this message board does not move this stock. What KB has said (more importantly, what he did not say) is going to move the equity. The market reaction is going to be negative. We shall see.
Yawn?
That's the market reaction I'm expecting.
I'm glad that they did not can Aim2Cerv program. The issue is how they are going to stretch the cash they have to fund all the current and future trials? The math simply does not work unless they get a big cash infusion soon. They can no longer rely on raising cash via secondary -- it will just kill the company. The cash balance is too low, and Bolivar cannot carry two. Maybe, he addresses the cash issue during the call. I am concerned no payment from Amgen is mentioned.
Aim2Cerv is alive, but how the hell are they going to fund this trial and the rest of the trials? No mention of any NEO milestones, no cash issues addressed. This is a nothing burger. We tank.
Advaxis Provides Update On Clinical Pipeline
November 2, 2018
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Continuing its Phase 3 AIM2CERV Study
Anticipates Data on ADXS-PSA, ADXS-NEO and ADXS-HOT (NSCLC) in 2019
Conference Call Today at 11:00 a.m. Eastern Time
"We believe this approach affords the best opportunity to demonstrate the therapeutic potential of drug candidates generated from our unique and proprietary Lm platform."
PRINCETON, N.J.--(BUSINESS WIRE)--Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, today announced that it will be continuing its ongoing Phase 3, randomized, double-blinded, placebo-controlled, pivotal study of axalimogene filolisbac (AXAL) in high-risk, locally advanced cervical cancer (AIM2CERV).
The current trial design has a planned sample size of 450 subjects to maintain adequate statistical power over a broader range of survival outcomes, as well as a pre-planned interim analysis (IA) of safety and efficacy. However, the Company is evaluating the possibility of accelerating the IA timeline and establishing a more stringent futility boundary. The Company anticipates that over the next couple of months it will finalize the redesign of the trial and review it with the U.S. Food and Drug Administration (FDA). During this time, the study is continuing to enroll patients under its current design, which is being conducted under a Special Protocol Assessment with the FDA.
“Based on discussions over the past several months with a number of experts in the field regarding our AIM2CERV trial, we have become increasingly optimistic about the prospects of this study. We believe that continuing to invest in this study, along with certain other product candidates, provides us with a diversified portfolio across drug constructs, cancer types and stages of development,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “We believe this approach affords the best opportunity to demonstrate the therapeutic potential of drug candidates generated from our unique and proprietary Lm platform.” He concluded, “The redesign of AIM2CERV with an earlier interim analysis would allow us to alter course or, if necessary, stop the study, depending on the results. If the FDA accepts our proposed revisions, we anticipate having a recommendation based on the interim analysis from the data monitoring committee as early as the fourth quarter of 2020.”
In addition to continuing its AIM2CERV trial for AXAL, the Company plans to initiate an investigator-sponsored trial with a major research center in head and neck cancer in early 2019. The Company is also continuing to follow subjects in its Phase 1/2 study of ADXS-PSA in combination with KEYTRUDA® in metastatic castration-resistant prostate cancer. Intriguing early data from 37 patients in this study presented at the American Society of Clinical Oncology (ASCO) earlier this year showed an improvement in survival in subjects with PSA declines from baseline of 50% or greater (~19% of all treated subjects). The Company expects to provide an update on survival rates along with correlative biomarker work in the first quarter of 2019.
To maximize the efficient use of clinical funding resources, the Company will not continue enrollment in its Phase 1/2 study of AXAL in combination with durvalumab for the treatment of patients with advanced, recurrent or refractory cervical cancer and HPV-associated head and neck cancer, and will not initiate its ADVANCE study for the treatment of women with persistent, recurrent or metastatic (squamous or non-squamous cell) carcinoma of the cervix.
The Company’s Phase 1 dose-escalation study of ADXS-NEO expressing personalized tumor antigens in subjects with various solid tumors, in collaboration with Amgen, is continuing to enroll subjects and Advaxis anticipates providing safety, tolerability and immune correlative data from the first two cohorts in the first half of 2019.
The Company also continues to progress its ADXS-HOT 503 drug candidate, expressing public (shared) tumor antigens both as monotherapy and in combination with KEYTRUDA® for the treatment of non-small cell lung cancer (NSCLC). The Company plans to have the first subject enrolled in this Phase 1/2 study by the end of 2018 with an anticipated readout of safety, tolerability and immune correlative data from the first cohort in the first half of 2019. The Company’s clinical testing of ADXS-HOT in prostate cancer and bladder cancer will continue as the next areas of focus. Initiation of clinical trials in each of these cancers will be delayed until early 2020 to ensure adequate funding for the Company’s other programs.
In support of these programs, Advaxis anticipates its annual cash usage to be approximately $45 million, which was reduced from an annual cash usage of approximately $80 million earlier this year.
The Company will be holding a conference call today, November 2, 2018, at 11:00 a.m. Eastern time to provide an update on its clinical programs.
Conference Call & Webcast Information
DOMESTIC DIAL-IN: (844) 348-6133
INTERNATIONAL DIAL-IN: (631) 485-4564
CONFERENCE ID: 1538717
WEBCAST: ir.advaxis.com/events-presentations
Waiting for a PR or 8-K at 8am this morning. If nothing, we are going to get a big, stale nothing burger.
This is a bifurcation point.
@wmtgreeter
Do you really want me to believe that someone from either company or PR firm shared a material/confidential info with you?
Are you an insider?
Quiet before the storm -- only this message board sends a shock wave after a shock wave.
Volume is under 70K after 80 minutes of trading. We will know tomorrow what transpires. Until then, it's just all hot air and useless prognostications.
I'm afraid it has nothing to do with their expertise -- it's them who run the game: HFT, algos, and high frequency posting...
The only DD possible is either a Deal or Dilution.
Not sure what conjectures you can make based on an obscure PR firm and a lady it works for. Butterfly effect?
That's a type of a deal we need.
https://finance.yahoo.com/news/gilead-sciences-tango-therapeutics-announce-123000666.html
Under the terms of the agreement, Tango will receive an upfront payment of $50 million. Tango will also be eligible to receive approximately $1.7 billion in total additional payments across all programs in the form of pre-clinical fees and development, regulatory and commercial milestone payments; and up to low double-digit tiered royalties on net sales. For those programs that Tango opts in to co-develop and co-detail, the parties will split profits and losses 50/50 for the U.S., development costs will be shared in a manner that is commensurate with product rights, and Tango will be eligible to receive milestone payments and royalties on ex-U.S. sales.
I find it interesting and troubling that Ranya Dajani is no longer a point of contact for potential partners. Recall that she's a VP, Business Development and was brought in to specifically work on deals and partnerships. Almost 2.5 years later, she has nothing to show for and now she signs press releases once a month. Typical waste of resources in NJ.
From ADXS web site:
Partners
Advaxis is actively seeking commercialization partners for the license and development of its proprietary investigational Lm Technology™ immunotherapies.
Advaxis has created more than 20 distinct immunotherapy candidates based on its proprietary platform that are available for partnering in anti-PD-1 combination therapy, recurrent cervical cancer, HPV-associated head and neck cancer, HPV-associated anal cancer, prostate cancer, HER2 expressing tumors, and others.
INTERESTED PARTIES MAY CONTACT:
Molly Henderson
Chief Financial Officer
Advaxis, Inc.
henderson@advaxis.com
609-250-7526
Wednesday morning tidbit:
So, what this is going to be -- Halloween or Hellofawin?
Answer: text a cash code AXAL to KEN666 for your chance to win 5 shares of Advaxis by 4:00pm tomorrow.
I sincerely hope you are going to be right in the end. However, you've been completely wrong on this equity so far.
B.liu wrote:"
Ah, it's just a manipulation. Nothing to worry about.
Well, I wouldn't use that garbage to flush clogged toilet. Too harmful to drainage. How about offering that "beer" to Kool Aid drinkers?
Don't discount they might file for EU conditional approval for one of the HOT indications in 2028. Refer to post 15,788,513 on this board.
When the ship starts sinking, some of the top brass would be looking for a next place to land, while the rest will be still collecting their paycheck and other benefits until the fat lady sings. Only then the cloud of green, fat locust would fly to green pastures to turn them brown.
As for the insider selling, nobody holds oversized stakes in this company. Most likely, they would eat their losses and walk away. After all, these shares mostly came as extra perk handed by the BOD. Easy come, easy go. The last insider open market purchases were not back breaking to the insiders, just a symbolic gesture to try to show confidence in the company's future.
5. FNY investment advisers, sold out, 30K shares.
FNY INVESTMENT ADVISERS, LLC 0.02 Sold All 30,000 0.0000% 13F 2018-09-30 2018-10-29
4. Colorado PE retirement fund sold out, all 16K shares
PUBLIC EMPLOYEES RETIREMENT ASSOCIATION OF COLORADO 0.00 Sold All 16,161 0.0000% 13F 2018-09-30 2018-10-29
3. Stonebridge reduced by 10K shares.
STONEBRIDGE CAPITAL MANAGEMENT INC 49,249 0.03 133 11,000 0.0936% 13F 2018-09-30 2018-10-17
2. Cutler Capital management sold out, all 100K shares.
CUTLER CAPITAL MANAGEMENT, LLC 0.06 Sold All 100,000 0.0000% 13F 2018-09-30 2018-10-17
1. Franklin St Advisors increased their stake by 60K shares.
FRANKLIN STREET ADVISORS INC 190,800 0.03 151 60,000 0.3626% 13F 2018-09-30 2018-10-05
Hey, you asked for 100/2 cents. Now that you almost got your wish, are you going to reload ta the half price you sold?
Somehow methinks you won't, right? Even darkIs's buddy would not touch this equity with a barge pole.
Now only Iggy has to admit that -- it's not about HFT, manipulations, and etc. It's about the management's failures, plain and simple.
Ken looks like is going to strike out on this one. Rosetta Genomics was Strike 1, Advaxis is Strike 2. Two strike outs in a single year! Think about it. What a great resume he has. No more CEO gigs, ever. Can Sidransky together with him, and send them to jail. Don't forget about cuffing and jailing DOC and Lombardo.
I wish I have never heard of this company.
#thankyouj&e
Now you assert that it's actually dead, or soon to be announced to be dead.
It's just pathetic to see how poster personalities make huge, 180-degree swings in a matter of days of weeks. Zoltie is not alone, Bater is a well known "retired dental assistant" with extreme mood swings. The list goes on and on. At least B.liu the Glue is consistent on his wrong stances.
I still believe they will announce a milestone payment from Amgen. No one knows for sure, and we are in another wait and see mode. Four more days to go. Patience.
Zoltie,
So now you "suddenly" turned bearish after being such a pumper for a while? What happened? This board is going nuts from what I see it...
Wrong, iggy.
Public companies have 4 business days to disclose most of the material events. This one falls into that category.
https://www.sec.gov/fast-answers/answersform8khtm.html
Regardless of what would be said during the CC next week, I think it’s a step in the right direction. They have made a mistake by skipping the call after the last earnings. The markets abhor uncertainty, and hopefully Ken realizes that. He needs to come out of the shadows and shed some lights on the path forward.
However, I think it would be more than just a simple update. Maybe, something tangible, finally.
As for Friday, all conjectures are not correct about the timing. Nothing special about 11am, except for some stock volatility during Ken’s talk.
I hope they provide an update on AXAL status. I’d like to hear about how they are going to fund HOT trial. But, most importantly, I expect them to disclose a milestone payment from Amgen.
Aratana mentions AT-014 in their presentation here
https://filecache.investorroom.com/mr5ir_aratana/288/download/CL%20King%20-%20PETX%20Corporate%20Presentation%209-13-18.pdf
They show no sales, just extended field studies. Their Q3 report will be out in a week.
BTW Aratana could buy us out as their market cap is almost 7x of ours. Pathetic. Watch Sellas target us, lol.
I said multiple times about those insiders buys — meaningless and an act of desperation. Likely BOD “advised” the too management to show confidence in the company and make open market purchases. Dollar wise, they were relatively small amounts and many argued otherwise. They have over the top compensation and it was a small tax for them.
Also, it sent a clear signal to shorts and others nothing material coming within two or three months.
Now that we have not seen any OPMs, I’d say don’t read too much into it. I’ve been waiting for a monetary deal for so long I’m tired of waiting. No deal by the end of this year - we are done completely. That’s my take.
What exactly are you celebrating? A party? Are we sold already? Did I miss something while counting idiots rushing into a local Walmart store for AXAL bargains?
what makes you think so?
Thursday morning tidbit:
Neon Therapeutics dosed 1st patient in NEO-PV-01 clinical trial on May 8, 2018
NEO-PV-01
and presented the data few days ago at ESMO.
Advaxis dosed 1st NEO patient on June 11, 2018. If the timelines are somewhat similar between NTGN and ADXS, then we should expect to see data by the end of this year, or early 2019.
Just set your alarm for 10am, November 2nd. This year, of course.
Or, ask b.liu to give you a wake up call.
Short interest down by 200K shares.
Settlement Date Short Interest Avg Daily Share Volume Days To Cover
10/15/2018 3,091,473 526,034 5.876945
9/28/2018 3,288,852 758,799 4.334286
You are most definitely wrong -- this is a methodical dumping of shares. Last remaining institutional funds are parting with their shares.
Wednesday morning cold shower:
A year ago, Advaxis had a poster presentation at ESGO in Vienna, Austria.
https://ir.advaxis.com/press-release/clinical-data-updates/advaxis-axalimogene-filolisbac-data-selected-poster
As far I as recall, there was a large Advaxis crowd in Austria, all pumped up with the upcoming submission for an EU approval, and etc. There was also an interview with Drs Marth and Ghamande (Immunotherapy: A New Strategy for the Treatment of Cervical Cancer. Interview with Dr. Christian Marth and Dr. Sharad Ghamande)
https://www.mdpi.com/2076-3271/6/1/9/htm
Just read if you haven't, but I cannot escape the notion the company tried too hard to pump this event up in anticipation of approval and hoping to influence the EU scientific community.
Snip:
"Q4. What is your vision for the future regarding this specific drug and immunotherapy in general?
R4. Most cervical cancers are caused by high-risk HPV, and have E6 and E7 oncogenes that are constitutively expressed, tumor-specific, and functionally important. That means cervical cancer can be attacked by different immunotherapy approaches more successfully than other gynecological cancers. We think that, along with ADXS-11, immunotherapy will play a big part in treating cervical cancer—mirroring the success of HPV vaccines in preventing cervical cancer."
And just few months later, they pulled EMA submission, and threatened to shelve AXAL altogether (maybe they did). What a complete 180-degree turn of the events. Money thrown away on expensive trips, expensive prep work, all in vain. BTW, it was our money, not theirs.
End of cold shower.
If this company goes bankrupt, shorts don't need your or my shares. They don't need to cover.