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Empery Asset Mngmt unloaded their entire position (600K shares). Likely knew the raise was coming. Perfect timing!
EMPERY ASSET MANAGEMENT, LP 0 28 600,000 0.0000% 13G 2019-12-31 2020-01-21
Also, the other big question re: this offering is this:
Who are those two "institutional investors"?
My guess would be Sabby Management is the first, and Boothbay (or CVI) is the other one. If so, we are screwed. Hope I am wrong.
Very active PM. Did not see any press releases and/or SEC filings. Obviously, something is up.
NTGN: they had an IPO just year and a half ago for $16. Acquired now for about $2. What a great return for the shareholders.
If ADXS were to follow their footsteps, we are screwed. At least, most of the legacy shareholders like me (as if we have not already been screwed).
Looks like delisting concerns are behind us. Whew...
I won't be surprised if the dark forces push the share price down to under a buck tomorrow, not today. Someone wants to slam this stock when there's finally a glimmer of home to avoid delisting. Could be so close, but no cigars. 9 out of 10, and then voila...
If you happen to know when the deal is coming would you mind to share the date with us, mortals?
There's not a word about AT-014 in the recent CP. Nothing, zip, nada...
In the most recent 10-Q:
Known destination -- where all Listeria go to die ...
Since my average price is higher than $100 (don't even remember if its' close to $150 or $200 -- does it matter?) the pain level is almost indistinguishable whether the share price is at 0.20 or 1.20.
Don't tell me to average down. Been there, done that. And the pain level got even worse.
So, we get an IND approval and the share price popped. Most of the investors assumed a deal or partnership to follow. Nothing happened and the share price has been on a decline since the pop. Is anyone surprised? Do you still expect a deal? (I'm not asking B. Liu that question though as we all know his answer).
We might not continue keeping the share price above a buck for 5 more trading days as there is a significant sell number of sell orders. Another cycle of false expectations. When do we learn?
Buy and hold is now officially dead. To stay above the water one must trade. Most of us are guilty for sticking with an old adage "Buy'n'Hold". C'est la vie.
From what I know, Ziopharm's CD19/POC clinical trial was put on hold when IND for it was under FDA review 18 months ago. It was ridiculous but the IND was approved more than a year later and the hold was lifted. Sheet happens.
I don't short stocks. However, I think you have a very valid question -- who's paying for it? It could be some deep pocket pharma is already lined up to sign a deal. Who knows. It's been too long for a paying partner to show up since the AMGN left. Let's see what transpires next.
Maybe it's because for a prostate cancer? Could MRK be interested?
The IND approval by itself should not move the stock.
As expected, Sabby sold out (all 1.5MM shares). How much larger their short position must have been? Nobody knows for sure, but I'd guess at least 3 to 5 times higher.
https://finance.yahoo.com/news/advaxis-announces-fda-clearance-ind-130010073.html
Advaxis Announces FDA Clearance of IND for ADXS-504 for Treatment of Prostate Cancer
GlobeNewswire GlobeNewswire•January 7, 2020
ADXS-504 is the Company’s second drug product candidate from the HOT program to receive IND clearance from FDA
PRINCETON, N.J., Jan. 07, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the initiation of a Phase 1 clinical study of ADXS-504, the Company’s ADXS-HOT candidate for prostate cancer. ADXS-HOT is the Company’s off-the-shelf neoantigen clinical program targeting hotspot mutations that currently includes over ten cancer-type specific drug constructs in various stages of development.
“With encouraging proof-of-concept data within our neoantigen program, we believe the ADXS-HOT program has potential to provide off-the-shelf, neoantigen targeted immunotherapies to a broad patient population,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “We are proud of the progress we have made to date with our HOT program, which includes advancing the clinical development of ADXS-503, our candidate for non-small cell lung cancer, while also seeking to launch our next clinical program, ADXS-504, in prostate cancer. We look forward to presenting immunogenicity and safety data from the first cohort from our lung program later this quarter.”
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.
To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statements that express the current beliefs and expectations of management, including but not limited to statements related to the expected clinical development of the Company’s drug product candidates. These and other risks are discussed in the Company’s filings with the SEC, including, without limitation, its Annual Report on Form 10-K, filed on December 20, 2019, and its periodic reports on Form 10-Q and Form 8-K. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. The Company cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date they were made. The Company undertakes no obligation to update or revise forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise.
Contact:
Tim McCarthy, LifeSci Advisors, LLC
212.915.2564
tim@lifesciadvisors.com
We are 3rd day in a row closed above $1.00 albeit there was a strong push to close it under a buck. Need 7 more of those days...
Will Advaxis attend the JPM conference this year? I haven't seen a PR yet, but who knows.
The share price spiked 30+ percent on a big volume. I'd like to think it's a news coming, but the history taught me be cautious. The recent run-ups were nothing but a bull trap. This could be no different than before. We shall see though. It's likely the short cabal playing the games -- run up the share price, sucker the retail into buying and short the heLL out of it when the SP rises hyperbolically.
I have said many times before -- I will never buy this stock. Ever. I'll ride out what I have originally invested that is currently down 99.5%. The management and the company have never convinced me they deserve any support. Not from me.
None of the nine Terry's catalysts materialized. 0 out of 9. Great predictions.
Terry should stick to writing SA articles and lead the other sheep to slaughter.
The next news from the company was supposed to be a start of Ph2 HPV+ lung cancer study by a Taiwan partner (2H2019), but the time has almost run out. So, guessing no news, no trial started. Maybe, the partner got cold feet.
Another "news" could be a termination of PSA trial and shelving the program. Merck, the potential partner for PSA program, has had lots of time to look under the hood and made no decision to jump in. Why? The only reasonable explanation is the data was not that impressive. ADXS cannot continue to pay for that trial, let alone take it to Phase 3. As the other trials before (Aim2Cerv, NEO, and etc), this PSA program is destined to wither and disappear from their corporate presentations. I'll give it a month or so. Then, the whole focus is going to be on HOT. Very binary outcome...
We all will be ecstatic for his 2nd anniversary bonus come April 2020. Incidentally, that event will be preceded by another RS and a secondary. G-d, I forgot how many secondaries have they had in the past 2 years. Four? Five?
From the last 13F filing:
SABBY MANAGEMENT, LLC 1,521,982 $403,000 51 1,480,260 8.8385% 13F 2019-09-30 2019-11-15
Everyone should be paying attention to that filing -- Sabby Mmgt increased their position by almost 1.5MM shares.
Sabby is a notorious short seller, charged by SEC for short selling violations. Why do you think they "increased" their "long" position? You know the answer -- they shorted many more shares in anticipation of the secondaries, and covered. But "kept" the rest to further manipulate the share price. We are at the mercy of a very aggressive short seller, and likely they hunt in packs.
ADXS short interest keeps climbing...
An increase of 589K shares from the last report.
SETTLEMENT DATE | SHORT INTEREST | AVG. DAILY SHARE VOLUME | DAYS TO COVER
12/13/2019 | 3096697 | 12230310 | 1
11/29/2019 | 2507933 | 9958009 | 1
11/15/2019 | 706163 | 3533420 | 1
The reason is simple — the clinical data are not mature and impressive enough to warrant a monetary deal. Everyone knows that including potential partners.
The run to 0.90 was likely orchestrated by the puppet masters. The management was not informed about the upcoming run up, thus the secondary was not negotiated yet. I think it was just a bull trap for velociraptors to make a killing when they shorted at the highs. Look at the Short Interest oscillations in biweekly reports. That tells it all.
James:
We all know the company cannot cut any more meat -- they'are down to 25 headcount. They literally cut it to the bone...
As for paying for the Aim2Cerv, I found this in the last 10-Q:
Cash and CEs as of 7/31/19 : $41.8MM
Cash and CEs as of 10/31/19: $32.4MM
Cash burn rate per quarter: $9.4MM
Annualized rate: $37.6MM (close to what they say).
Well, with this cash burn rate they are out of cash by mid-August 2020. Why they keep saying "we cash into early 2021"? Even though they mean a financial year that starts 11/1/2020 -- not a calendar year -- it's almost three months shorter than they estimate. If they are to replenish their coffers by 6 months before it's on E, the raise will be no later than March, but likely in February 2020. Will they have a solid data by then? Not likely. So, how they are going to pull this off then?
https://finance.yahoo.com/news/advaxis-reports-fiscal-2019-financial-130000000.html
Advaxis Reports Fiscal Year 2019 Financial Results and Provides a Business Update
Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announces its financial results for the fiscal year ended October 31, 2019 and provides a business update.
Fiscal Year 2019 and Recent Key Accomplishments
Completed enrollment in the first and second dose levels in Part A of the ongoing Phase 1/2 trial evaluating ADXS-503, the Company’s ADXS-HOT drug candidate in non-small cell lung cancer, with immune response data anticipated in early 2020.
Completed manufacturing of ADXS-506, the Company’s ADXS-HOT drug candidate for bladder cancer, enabling future potential clinical development.
Reported early immune response data from the Phase 1 ADXS-NEO study demonstrating the generation of CD8+ T cells against hotspot neoantigen mutations. These results serve as an important proof-of-mechanism for the Company’s off-the-shelf ADXS-HOT program which targets common hotspot mutations found in tumors.
Announced updated overall survival from the KEYNOTE-046 Phase 1/2 trial evaluating ADXS-PSA in combination with KEYTRUDA® in metastatic castrate resistant prostate cancer. Median overall survival increased to 33.6 months from the previously reported 21.1 months.
Entered collaborative research agreement with University of California, Los Angeles to investigate anti-tumor immunity and responses generated by Lm vaccines targeting glioblastoma neoantigens.
Continued pipeline prioritization efforts enabling the reduction of operating expenses and extension of cash runway into early 2021.
Management Commentary
"Fiscal year 2019 has been marked with continued progress in the strategic advancement of our most promising clinical programs," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "With encouraging clinical proof-of-concept data, we are focused on developing and expanding our off-the-shelf neoantigen program, ADXS-HOT, and look forward to sharing immunogenicity data in early 2020. In addition, the announcement of significant improvements in overall survival from our KEYNOTE-046 study in prostate cancer further bolsters our confidence in the power of our Lm technology to improve patient outcomes and potentially shift the immunotherapy treatment paradigm. These promising data, in combination with our successful efforts to reduce cash burn and increase efficiencies, leave us positioned to execute on our innovative immunotherapy clinical pipeline."
Balance Sheet Highlights
As of October 31, 2019, Advaxis had cash and cash equivalents of $32.4 million. The Company used $36.1 million in cash to fund operations during fiscal year 2019, mainly attributed to funding research and development and general and administrative activities. Throughout fiscal year 2019, the Company continued a strategic pipeline prioritization across all programs and reduced its annual expenses by approximately $37.6 million, or nearly 50%.
Fiscal Year 2019 Financial Information
Research and development expenses for fiscal year 2019 were $26.7 million, compared with $57.0 million for fiscal year 2018. The $30.3 million decrease was primarily attributable to decreases in clinical trial costs, laboratory costs, drug manufacturing process validation and drug stability studies.
General and administrative expenses for fiscal year 2019 were $12.2 million, compared to $19.5 million for fiscal year 2018. The $7.3 million decrease was primarily attributable to the institution of control cost measures for non-essential items in areas that did not support the strategic direction of the Company, as well as a reduction in external costs associated with strategy, business consulting and regulatory in fiscal year 2018 that did not recur in fiscal year 2019.
The net loss for the fiscal year ended October 31, 2019 was $16.6 million or $1.09 per share based on 15.2 million weighted average shares outstanding. This compares with a net loss for fiscal year 2018 of $66.5 million or $19.36 per share based on 3.4 million weighted average shares outstanding.
About Advaxis, Inc.
Advaxis, Inc. is a clinical-stage biotechnology company focused on the 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.
To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube.
They have 170MM shares authorized, per recent 10Q. The fully dilutes share count is about 51MM. Technically, they don't need to authorize new share, but they need an ability to comply with NASDAQ requirements within few months. The only way they can do that is to push the share price to over 1.00 and hold there for 10 consecutive days or more. It's hard to do if there are no catalysts. The management likely knows nothing of that scale is going to happen, thus the quick and dirty option is going to be pushed on us -- another reverse split. The proxy is expected to be out within a month, and the markets know it and they will be shorting the hell out of this stock in an anticipation of the proxy. Wash, rinse, repeat...
In the corporate presentation, the numbers don't add up.
The cash and cash equivalents as of 7/31/19 is $41.8MM. The 9-months expenses are $28.5MM which prorates to $38MM for year. Even I as a GED holder can do a simple math and see that they'll be running empty by mid-August 2020. However, the CP states "Positive Cash Balance Anticipated Into Early 2021". So, who's lying?
Short interest jumped by 1.8MM shares. Again. Yo-Yo.
SETTLEMENT DATE SHORT INTEREST AVG. DAILY SHARE VOLUME DAYS TO COVER
11/29/2019 2507933 9958009 1
11/15/2019 706163 3533420 1
TW partner starting their lung cancer trial will not move a needle. They will not provide any upfront cash to ADXS, however, they pay for the trial. It's a non-event. Can you recall what happened to another investigator sponsored trial (OS Therapies for pediatric osteosarcoma) that started in 2018? What happened to an IST trial for H&N cancer that was supposed to start in 2019/H1? Those ISTs are just some decoy operations designed to stir a trading activity. Never materialize into something tangible. Never. It's not going to be different this time around.
You beat me by a second, lol...
Shocking to see the headcount is down to 25. Wow.
Two big acquisitions this morning: THOR for $2.5B (almots 170% premium) and ARQL for $2.7B (over 100% premium). Where do we fit now?
https://www.marketwatch.com/story/sanofi-to-acquire-synthorx-for-25-billion-2019-12-09-2103842?siteid=yhoof2&yptr=yahoo
https://www.businesswire.com/news/home/20191209005234/en/Merck-Acquire-ArQule-Advancing-Leadership-Oncology
It's a nothing burger. I wish they had announced a partnership at this point, not even an IND approval would not cut it. This is going to be another source of accelerated cash burn. The share price reaction is not going to be favorable.