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Advaxis is trying to execute another round of a cash raise: plain old secondary or a partnership? Remains to be seen, but I'd guess participating at the 2nd or 3rd tier conferences is pretty meaningless. They skipped ASCO -- that's not good. Molly the CFO wants a capital raise which is almost impossible to accomplish now on any meaningful terms. We shall see..
Advaxis to Participate in Five Upcoming Industry Conferences
Business Wire Business Wire•May 7, 2019
PRINCETON, N.J.--(BUSINESS WIRE)--
Advaxis, Inc. (ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, announces participation in five upcoming industry conferences:
BioNJ 9th Annual BioPartnering Conference
Date and Time: Wednesday, May 8, 2019 at 2:00pm ET
Venue: The Palace at Somerset Park - Gatsby Suite, Somerset, New Jersey
Presenter: Molly Henderson, Executive Vice President and Chief Financial Officer
Presentation: Corporate overview
Frontiers in Cancer Immunotherapy
Date: Tuesday, May 14, 2019
Venue: The New York Academy of Sciences, New York, New York
Presenter: Robert Petit, Ph.D., Chief Scientific Officer
Two Poster Presentations: Safety and Immunogenicity of a Personalized Neoantigen-Listeria Vaccine in Cancer Patients; and Effects of ADXS-PSA With or Without Pembrolizumab on Survival and Antigen Spreading in Metastatic, Castration-Resistant Prostate Cancer Patients (Results from KEYNOTE-046)
Immuno-Oncology Xchange
Date and Time: Wednesday, May 15, 2019 at 12:30pm ET
Venue: Seaport World Trade Center, Boston, Massachusetts
Presenter: Andres A. Gutierrez, M.D. Ph.D., Chief Medical Officer
Presentation: Challenges of First-in-Human Phase I Dose-Escalating Trials in Patients with Advanced Cancers
BIO International Convention
Date: June 3-6, 2019
Venue: Pennsylvania Convention Center, Philadelphia, Pennsylvania
Management holding partnering meetings: Ken Berlin, President and Chief Executive Officer, and Molly Henderson, Executive Vice President and Chief Financial Officer
IO Combinations 360°
Date and Time: June 20-21, 2019 at 12:00pm ET
Venue: Wyndham Historic District Hotel, Philadelphia, Pennsylvania
Presenter: J. Randolph Hecht M.D., Professor of Clinical Medicine, David Geffen School of Medicine at UCLA and Director of the UCLA Gastrointestinal Oncology Program
Presentation: A Phase 1 Dose-Escalation Study of ADXS-NEO Expressing Personalized Tumor Antigens in Subjects with Advanced Solid Tumors: Updated Results
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 T cells to eliminate tumors. Advaxis has four programs in various stages of clinical development: ADXS-HPV for cervical cancer; ADXS-NEO, a personalized neoantigen-directed therapy for multiple cancers; ADXS-503 for non-small cell lung cancer, from its ADXS-HOT off-the-shelf neoantigen-directed program; and ADXS-PSA for 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 subject accrual; our ability to avoid any clinical holds and to resolve FDA’s partial clinical hold; 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; our ability to get FDA approval for study amendments; the timing of data read-outs; the ability of our product candidates to successfully perform in clinical trials; our ability to initiate, enroll, and execute pilots and clinical trials; our ability to maintain collaborations; 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190507005615/en/
I wish I shorted stocks. Then, I would directly short ONCS and any other that are actively promoted by Advaxis board experts.
That way you could make up for losses in Advaxis.
Not a tidbit, but the harsh reality: this stock has made too many investors to lose a very big chunk of their money. Too many folks have their retirement accounts obliterated. Too many invested too much into this company. Understand that it’s their fault in the end, but it’s very instructive to learn how and why it happened. Too many wanted a quick return, but instead they all got burned badly.
While you are at it, why don't you also ask him if did get his annual bonus.
Ken did not commit a crime - at least, not until now. There's nothing in public that can implicate Ken. It's just an incompetence, and a dire business situation that Advaxis was put in by the previous CEOs. The other things, including HF shenanigans (J&E, raises, warrants, SP control), is not on Ken. This is beyond his control. He's a pawn in that game.
Thursday morning tidbit:
Last day at work for Ken as he leaves NJ for a vacation destination late tonight. Happy sailing, Ken! Hope you learn few words in Magyar.
While searching for a field safety study for AT-014, I have stumbled into another(?) canine trial. Any thoughts?
(there is also listed a safety study followed by this trial -- just scroll down a little).
http://www.petcancercenter.org/Clinical_Trials_Current_Dogs_Bone.html
MULTIPLE LOCATIONS
Study: Evaluation of a recombinant, attenuated Listeria monocytogenes expressing a chimeric human
HER2/neu protein in dogs in the adjuvant setting for osteosarcoma
Recruitment Open until 12/31/2019
Locations:
Colorado State University (Fort Collins, Colorado)
Kansas State University (Manhattan, Kansas)
Tufts University (North Grafton, Massachusetts)
Ohio State University (Columbus, Ohio)
University of Pennsylvania (Philadelphia, Pennsylvania)
Purpose of Study:
This clinical trial seeks dogs with osteosarcoma to evaluate the safety and effectiveness of a new vaccine following standard
of care therapy. Bone cancer or osteosarcoma (OSA) is a common, highly aggressive cancer that frequently affects the
long bones of large breed dogs. Current standard of care therapy consists of surgical limb amputation plus 4 doses of
chemotherapy, given in a vein, every 3 weeks.
The immune system plays an important role in identifying and targeting cancer cells in the body. In this study, we aim to use
a new approach to stimulate the body’s own immune system to attack remaining tumor cells in dogs that have undergone
limb amputation and chemotherapy for the treatment of OSA. We will use a study vaccine, which has been modified to
express a tumor protein (HER-2/neu) that is found in many cancer cells, including canine bone cancer cells and cancer stem
cells. The hope is that when injected into the bloodstream, the vaccine stimulates the immune system to attack cells
expressing the HER-2/neu tumor protein. This approach aims to delay and/or prevent the spread of cancer (metastases)
following removal of the primary bone cancer tumor (limb amputation) and chemotherapy. Interactions with other drugs are
unknown, so it is necessary to disclose any medications (and supplements) your dog is currently taking to the oncologist. It
is strongly encouraged to eliminate all unnecessary medications. .
Inclusion Criteria:
Dogs greater than 50 pounds post-amputation surgery with histological or cytological confirmation of appendicular
osteosarcoma, which includes all long bones of the limbs (radius, ulna, humerus, scapula, femur and tibia) PRIOR to
amputation. Dogs must have measurable disease that is amendable to surgical removal via amputation and no evidence of
metastasis on physical exam, thoracic radiographs, and abdominal ultrasound. Dogs must be newly diagnosed without prior
therapy (conventional or metronomic chemotherapy, ionizing radiation, or bisphosphonates.) Dogs must not have significant
co-morbid illness (including but not limited to renal or hepatic failure, history of congestive heart failure, or clinical
coagulopathy) and certain blood work parameters must be met.
Exclusion Criteria:
Dogs less than 50 pounds with osteosarcoma on non-long bones including ribs, metatarsus, metacarpus, carpal and tarsal
bones, and digits. Dogs with evidence of metastasis or who have already undergone amputation or who have prior therapy
for osteosarcoma are excluded. Dogs with significant co-morbid illness (including but not limited to renal or hepatic failure,
history of congestive heart failure, or clinical coagulopathy) or who do not meet blood work parameters will be excluded.
Potential Medical Benefits:
Potential delay of metastatic disease.
Potential Medical Risks:
Fever, lethargy, gastrointestinal upset (vomiting, diarrhea, inappetence), cardiac arrhythmias, hyper/hypotension, low
platelet counts (blood clotting cells), high or low white blood cell counts, anemia (low red blood cells), worsening kidney
function, elevated liver enzymes, rash, sepsis, even death. This is an experimental drug that may affect your dog in ways
unknown.
Owner Responsibilities:
If you allow your dog to participate in this study, you will be responsible for having the limb amputated at UC Davis, bringing
your dog to all required study appointments, recording their rectal temperature 12 hours after your pet receives each
vaccine, reporting any side effects, and covering costs of the initial examination with the UC Davis Oncology Service, the
screening diagnostic tests, which includes blood and urine collection and analysis, chest x-rays and abdominal ultrasound
and amputation, the four doses of carboplatin (as well as the associated tests, which includes bloodwork and chest x-rays),
any costs associated with management of side effects from the Standard Therapy Phase of this study (amputation and
carboplatin chemotherapy)..
Cost:
Partially funded (owner cost >$1000).
If there's something that could save us from annihilation, it's definitely NOT AT-014.
The extended field study was started 02/15/18, and the recruitment should be complete by 02/15/19:
https://ebusiness.avma.org/aahsd/study_search_detail.aspx?sid=4607&rel=0
Since the median survival time was 965 days for the initial trials on 18 dogs, it's reasonable to expect that they would like to see median survival time for the extended group, for higher p-value. Thus, it would take about 3 years to see the data once the recruitment is complete. That's about February '22. There's no chance on Earth the company would survive until then relying just on AT-014 milestones. Someone else would be harvesting the fruits of this vaccine.
We all wish Ken hand delivered his response to the FDA via Advaxis corporate jet. Since they have been cutting the costs, they resorted to pigeons to deliver the messages. The birds are unreliable especially with the interference from the cell towers. Thus, the delays.
Pretty big jump in the short interest (up 48%), post reverse split. Even with the assumption that many might have covered before this last report.
Settlement Date Short Interest Avg Daily Share Volume Days To Cover
4/15/2019 363,485 1,944,594 1.000000
3/29/2019 246,026 294,593 1.000000
3/15/2019 207,099 186,814 1.108584
That's 40% premium from the last close. I hope Elanco will not shelf AT-014, and finds a way to deliver it the markets after a full approval. At least, this program is listed on the "best-in-class" Aratana portfolio list.
As an honorary corporate dental hygienist for Trip Advisor, Batermere has an executive account with them, thus, he can monitor every trip made worldwide.
PS. Correction: orthodontist, not hygienist.
Certainly bankruptcy is one of the Ken’s areas of expertise. The company will be held steady during these proceedings — we can count on it.
Batermere,
It’s not Rhine River, it’s Danube River. Devil is in the details.
He should be getting an annual bonus of up to 250K for his underperformance. Look for Benjamins floating on the Danube River once Ken starts partying...
Tuesday morning tidbit:
Today marks the first anniversary of Ken's tenure as our CEO -- he was hired on 4/23/18. Anyone wish to congratulate him for his hard work and dedication to make Advaxis great again? I thought so too...
He'll be taking a vacation trip to Europistan in ten days. A Danube river cruise for few days, then few more days in the Austrian Alps. Why not? He's due to get an annual bonus of up to 50% of his salary. Why not enjoy life while his company's shareholders remain deep underwater? Who says it's an unethical?
Some changes in HOT clinical trial:
https://clinicaltrials.gov/ct2/history/NCT03847519?A=1&B=2&C=Side-by-Side#StudyPageTop
Mostly, in the "Arms and Interventions" section. Also, Cleveland Clinic was dropped, and Carol G. Simon Cancer Center was added (NJ).
Monday morning tidbit:
It's been a year since Ken Berlin was hired as a CEO. Here's a list of his accomplishments:
1) Two extremely dilutive raises that literally obliterated legacy holders;
2) 12+ million warrants were exchanged for free shares which were then dumped into a market;
3) Amgen partnership termination;
4) Aim2Cerv hold for over 3 months and counting;
5) 150K bonus for the 1st secondary, and an annual bonus of up to $500K soon;
6) Two luxurious vacation trips to the islands;
7) Almost 50% reduction in the workforce'
8) No deals/no partnerships.
Did I miss anything?
I've searched with different keywords -- no luck. It appears they have no abstracts at ASCO this year. That's a shame. Talk about multiple catalysts this year. ASCO was supposed to be the forum to highlight the data and the platform, and voila...
Now what?
ASCO '19 Abstract titles are now available online -- I do not see abstracts from ADXS.
I wouldn’t be so sure that $3 is going to be a floor. Absent any positive news within a few weeks or months, the share price might surprise even the most notorious board pessimists. There is no institutional support for this equity. All newly issued shares apparently have been used to cover previous naked short positions. The question is how many short positions are yet to be covered and at what levels.
Beyond sad...
Also, he's taking another vacation early May. This time, it's not sandy beaches and bare naked girls in the islands -- it's a river cruise in Europe. Details to be posted soon.
While Ken will be celebrating his 1st anniversary at Advaxis in a week, I'm to remind you that he's due for a big fat annual bonus if he survives until then. The bonus contingency is not too clear, but given the low standards at Advaxis I see not reason he's denied a lump sum of money (up to 50% of his salary). Not too shabby for his horrendous track record.
I will roast a crow for you if your predictions fail to materialize. Care to post your shipping address?
Just compare two charts: ADXS and AKAO. Stunning similarities!
Another biotech files for Chapter 11...
Notice their MC was just above 30M before filing for a bankruptcy. They had an approved drug in the markets, EV higher than the entire MC, but could not make it. What chances does Advaxis have now?
https://seekingalpha.com/news/3450567-achaogen-files-bankruptcy-protection
Achaogen files for bankruptcy protection
Apr. 15, 2019 7:58 AM ET|About: Achaogen, Inc. (AKAO)|By: Douglas W. House, SA News Editor
Longs in nano cap Achaogen (NASDAQ:AKAO) are facing a near-total wipeout this morning on the news that it has filed for Chapter 11 bankruptcy protection.
Trading is currently suspended.
Update: Shares are down 57% on resumption of trading.
As much as I dislike the management, I wouldn’t wish them that. Be careful with your wishes. Karma is a bitch.
so, 600K shares.
I see them bought 600K shares. Where did you see over 2M shares?
Some new info for PSA and NEO has been added (from AACR-19), and ADXS-HOT PSA IND submission pushed into 2H/19 from the first half. Otherwise, no new information.
That's an insult to janitors.
Again, I do not see any positive in those recent insider buys. The not-so-positive indication is that there is no material event likely within a month or so, at least. The top management would not be buying now if they had a concrete, stock moving offer on their table.
If Bob Petit jumps, the game will be over.
Nobody has been defending that $4 level -- a no show from the "new owners". Another confirmation that they used new shares to cover their previously established naked short positions.