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What profits? In 4-5 years? Do you realize the company will not be around by that time? If the IST collaboration were to bear any fruits, they would be harvested by another entity that grabbed Advaxis remains for a fraction of penny per dollar.
KB: "We are continuing to evaluate various ways to accelerate bringing more of our HOT constructs into the clinic, such as through additional investigator-sponsored trials and other collaborations."
Again, translation: No big pharma has expressed significant enough interest to sign a deal with us, thus we are giving away our platform fro free.
From the CC:"We are in discussions with a leading academic institution to finalize an investigator-sponsored trial evaluating ADXS-HOT in patients with prostate cancer and anticipate the IND for this construct will be filed later this year."
Translation: We are unable to partner HOT with a leading pharma to get us a so much needed cash, thus we are giving it away before the lights are off.
I did not listen to the call, thus, a question. Were "term sheets" mentioned during the call? Or, did Ken try to avoid them at all?
Looks like the call is going well...
1) CC starts in few minutes;
2) They are just seeking for a protocol modifications. We are 3 years from the data readout, then a year or longer to an approval. Interim read out could help, but that timeline is a killer. The company will not survive until then.
"The company is in discussions with the FDA to allow for an earlier interim analysis for efficacy under proposed revisions to the AIM2CERV protocol."
That golden parachute might end up being too heavy for Ken -- falling upon him and crushing his bones like a boulder.
Ranya Dajani, our former glorified press-secretary, is now a business development consultant at Cabaletta Bio. Why such a small company would hire a secretary?
https://www.linkedin.com/company/cabalettabio/about/
Overview
Cabaletta Bio is focused on the discovery and development of T cell therapies for B cell-mediated autoimmune diseases. Cabaletta’s therapeutic platform produces highly selective autologous Chimeric AutoAntibody Receptor (CAAR) T cells that are designed to precisely bind and destroy only specific autoantibody-producing B cells while sparing normal antibody-producing B cells, which are essential for human health. The platform is based on the revolutionary Chimeric Antigen Receptor (CAR) T cell technology developed at the University of Pennsylvania that resulted in one of the first commercially-available CAR T cell products for the treatment of B cell malignancies. Cabaletta has an exclusive global licensing agreement and multiple sponsored research agreements with the University of Pennsylvania to develop the CAAR T technology to treat B cell-mediated autoimmune diseases. The Company’s lead therapeutic program is a potential treatment for a prototypical B cell-mediated autoimmune disease, mucosal pemphigus vulgaris (mPV), which is a rare skin disorder that causes painful blisters and sores on mucous membranes leading to severe and sometimes debilitating and life-altering effects. An IND submission is planned for 2H19.
Website http://www.cabalettabio.com
Industry Biotechnology
Company size 2-10 employees
Headquarters Radnor Township, Pennsylvania
Type Privately Held
Founded 2017
Raja,
Do you still trade Advaxis? Any gains? I wish I shorted the stocks -- I'd short this pos. The writing's on the wall.
Not sure why they hold a conference call today. They skipped a call after Q1 in March. Why now? I'd guess they'll try to pump it up the very last time and then try to raise some cash. Expect few fluff PRs after this call and a raise. The secondary will kill us faster than a non-raise. This company will be in a bankruptcy protection by the end of 2019.
IST will do nothing to this stock. It's a non-event, and not what investors have been anticipating. Need something much more positive, anything that involves a cash transfer to Advaxis except for the dilutive raise.
The absence of news always means a bad news here. We will tank. Once we reach 10M market cap, the company will seek for a Ch11 or Ch7 protection. Just what KB did at ROSG. This translates to a share price in 1.40 area. There's no way the company can raise any substantial amount of money via secondary. They must be delusional to think so.
We will tank tomorrow. Nothing new, same old. The management is counting on another dilutive raise soon. Sounds like no deals, and "the term sheets" are now shredded.
NEO: so much for a potential cure. Two patients with SD.
Mind boggling they have not been able to sell any part of their program. Cash is under 28M now, and they will not be around for too long. Pathetic.
... since 2015. Too early to call either way yet.
Lack of the capital is the only problem? Really?
That problem is the manifestation of the other numerous issues compounded over the years of the managements missteps and the lack of the execution. Now it’s becoming more clear that the science is not that stellar and keeps failing behind rapid advancements made by the other pioneering companies. Thus, the money started flowing away from Advaxis leading to the current cash problems. Why do fail to see that?
Another offering if it were to happen would be on such terrible terms that it would be the last one for this company. The only way to salvation is to get a cash deal before either a bankruptcy or a reverse merger. Reverse merger virtually means a total loss for the legacy shareholders similar to a bankruptcy.
I'm curious about absence of any lawsuits. why's that?
The top management has been replaced by totally new people, but we have the same BOD. Where are the ambulance chasers?
You need to establish a non-profit "Dentists4bridges" and help those homeless with their dental problems -- caries, root canals, crowns, and bridges. Your under-the-bridge life would make a top dentist in that organization. Keep in mind that the longer Advaxis continue to exist, the more homeless we get.
Ken is playing a 3D chess game as some here suggested. We are just pawns in that game, or a sacrificial material to achieve the ultimate goal of curing cancer. Do you not want a cure for cancer? Or, are you just concerned about losing all of your investment?
A gambit (from ancient Italian gambetto, meaning "to trip") is a chess opening in which a player, more often White, sacrifices material, usually a pawn, with the hope of achieving a resulting advantageous position
https://en.wikipedia.org/wiki/Gambit
A bridge to nowhere. Thought it was a bridge to the paradise.
I’m already homeless thanks to Advaxis. Done betting house on this pos.
One in a million? So, are you saying we still got a chance?
There is no way in h&ll the company can sync their PR with the conference call. Happens so rarely, any material information must be released within few days. If you refer to IST, then it's a non-event and can be released as they wish.
As I stated before, I expect a flurry of fluff PRs around this conference call, before and after. The intent is to run another secondary -- the last one. There's no Naloxone Hydrochloride (aka Narcan) for companies like Advaxis to revive from overdose of greed, missteps, and utter failure to execute.
Company stopped responding over a year ago.
Bankruptcy will not going to be announced by this CC. It has to wait until the next CC if the call ever happens. They will be filing for Ch 11 (or Ch 7) once the market cap drops to 10M. We are at 21M right now, so the share price has to drop to 1.40 area. Then, a bomb will be dropped.
My guess would be the following. After the CC, they'll try to issue few PRs regarding the clinical updates. The data will be not so impressive, and the stock will not move upwards. As few times before, the management will use these fluff PRs to pump the SP and do another raise. It will be the final raise at this point as the monetization of the platform has not happened. With the need to run 4 or 5 clinical trials and a lack of the funds to support these trials, the company will have no choice but to file for a bankruptcy as the cash burn will be too high. It's mind boggling that this company has been unable to sell anything -- not NEO, not HOT, not PSA, not AXAL. Why? The clinical data does seem to be just so-so, not too impressive to turn some corporate heads. Thus, the younger and more attractive companies and techs get taken out. Not us. We are as afterthought in the immuno oncology area.
Tuesday morning tidbit:
Yesterday was the 1st day for Beto Petito to be in a consultant role for Advaxis rather than CSO. Hope he has a better prospects in his further career than joining another disaster in the making -- Oncosec.
It was repeated here ad nauseam: IST means no money. How hard is that to comprehend?
Need my eyes checked -- Advaxis is grrreeeen.
No doubt the stock has been acting as if either is coming:
1) another super-dilution;
2) bankruptcy.
It used to be on the corporate presentations couple years ago. From 08/2017 CP (I have almost all of those CPs), I can see that 3 patients were on the combo H&N trial. Two had a stable disease for a while, but one of them died, while the other continued the treatment. The 3rd patient obviously showed no response and then died. We have never got an update on the combo H&N trial, as it was put on hold first, then shelved. We all thought it was dead, so why Advaxis is trying to resurrect it now? Do they have lots of extra cash to throw around? Beats me.
Although we've been waiting for Advaxis to sign an IST for H&N cancer for a while, it looks like it may not happen at all. The competition (MRK) will have a PDUFA soon for Keynote-048 trial with good results, and we are no match. Just recall how pathetic H&N clinical data was for AXAL in combo therapy (durvalumab).
https://www.apnews.com/Business%20Wire/f9d11e4c0d404106b9aef952a44ac965
Merck’s KEYTRUDA® (pembrolizumab) Demonstrates Improved Overall Survival as First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma at Final Analysis of Pivotal Phase 3 KEYNOTE-048 Trial
Merck’s KEYTRUDA® (pembrolizumab) Demonstrates Improved Overall Survival as First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma at Final Analysis of Pivotal Phase 3 KEYNOTE-048 Trial
an hour ago
KENILWORTH, N.J.--(BUSINESS WIRE)--May 31, 2019--
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the presentation of the final analysis of the pivotal Phase 3 KEYNOTE-048 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy and in combination with chemotherapy, for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #6000). Data include the first-time presentation of certain overall survival (OS) hypotheses from the KEYTRUDA in combination with chemotherapy study arm based on PD-L1 expression and the KEYTRUDA monotherapy study arm in the total patient population. Results of an interim analysis were presented at the European Society for Medical Oncology (ESMO) 2018 Congress and demonstrated superior OS outcomes for KEYTRUDA in combination with chemotherapy in the total population and KEYTRUDA monotherapy in patients whose tumors expressed PD-L1 with Combined Positive Score (CPS) ≥20 and CPS ≥1 compared with the EXTREME regimen, the current standard of care.
“It is exciting to see the full results from this trial, which is the first study to show superior overall survival over the current standard of care known as the EXTREME regimen,” said Dr. Danny Rischin, director of the department of medical oncology, Peter MacCallum Cancer Centre, Melbourne, Australia. “Patients with recurrent or metastatic head and neck cancer have a poor prognosis with limited treatment options. These findings underscore the potential of KEYTRUDA monotherapy and in combination with platinum-based chemotherapy to become important new treatment options.”
The new findings presented today from the final analysis showed that KEYTRUDA in combination with chemotherapy (carboplatin or cisplatin plus 5-FU) reduced the risk of death by 40% in patients whose tumors expressed PD-L1 with CPS≥20, demonstrating significantly longer OS (14.7 months [95% CI, 10.3-19.3]) compared with the EXTREME regimen (cetuximab with carboplatin or cisplatin plus 5-fluorouracil [5-FU]), the current standard of care (11.0 months [95% CI, 9.2-13.0]) (HR=0.60 [95% CI, 0.45-0.82]; p=0.0004). For the dual primary endpoint of progression-free survival (PFS), statistical significance was not achieved for KEYTRUDA in combination with chemotherapy in the CPS≥20 population compared with the EXTREME regimen (HR=0.73 [95% CI, 0.55-.97]; p=0.0162). New findings for the CPS ≥1 population showed KEYTRUDA in combination with chemotherapy reduced the risk of death by 35% in these patients, with significantly longer OS (13.6 months [95% CI, 10.7-15.5]) compared with the EXTREME regimen (10.4 months [95% CI, 9.1-11.7]) (HR=0.65 [95% CI, 0.53-0.80]; p<0.0001). Per the sequential testing strategy, superiority for PFS was not tested in this population (HR=0.82 [95% CI, 0.67-1.00]). Results for OS with KEYTRUDA monotherapy in the total population were consistent with the previously presented interim analysis, where non-inferiority was demonstrated (HR=0.83 [95% CI, 0.70-0.99]; p=0.0199), with a median OS of 11.5 months (95% CI, 10.3-13.4) for KEYTRUDA monotherapy in the total population compared with 10.7 months (95% CI, 9.3-11.7) for the EXTREME regimen. There was no difference in PFS between KEYTRUDA monotherapy in the total population and the EXTREME regimen (HR=1.34 [95% CI, 1.13-1.59]).
“As a company, Merck is committed to advancing research in this challenging treatment setting through our expansive head and neck cancer clinical research program,” said Dr. Jonathan Cheng, vice president, clinical research, Merck Research Laboratories. “The full data from KEYNOTE-048 illustrate the impact of KEYTRUDA as monotherapy and in combination with chemotherapy as potential new first-line treatment options for patients with recurrent or metastatic head and neck squamous cell carcinoma. We would like to sincerely thank the patients and investigators for their involvement in KEYNOTE-048.”
As previously announced, the U.S. Food and Drug Administration (FDA) has granted priority review for a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA as monotherapy or in combination with platinum and 5-FU chemotherapy for the first-line treatment of patients with recurrent or metastatic HNSCC based in part on data from the second interim analysis of KEYNOTE-048. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 10, 2019.
Study Design and Additional Data from KEYNOTE-048 (Abstract #6000)
KEYNOTE-048, a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT02358031), evaluated KEYTRUDA in combination with chemotherapy or KEYTRUDA monotherapy, compared with the EXTREME regimen, as first-line treatment in patients with recurrent or metastatic HNSCC. The dual primary endpoints were OS and PFS. The secondary endpoints were PFS (at six months and 12 months), objective response rate (ORR) and time to deterioration in the Quality of Life Global Health Status/Quality of Life Scales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire and Safety. Duration of response (DOR) was evaluated as part of a pre-specified exploratory analysis. The primary and secondary endpoints, as well as exploratory DOR analysis, were evaluated in patients whose tumors expressed PD-L1 (CPS ≥20 and CPS ≥1) and in the total population, based on a fixed sequential testing strategy. Data cutoff for the final analysis was Feb. 25, 2019; data cutoff for the previously presented second interim analysis was June 13, 2018. Details of the OS benefit observed at the final analysis are below:
Summary of Overall Survival
Population (number of patients with event) Final Analysis Hazard Ratio (95% CI)
KEYTRUDA Monotherapy
PD-L1 CPS ≥20 (n=133) vs. EXTREME (n=122) 0.58 (0.44-0.78) b
PD-L1 CPS ≥1 (n=257) vs. EXTREME (n=255) 0.74 (0.61-0.90) b
Total Population (n=301) vs. EXTREME (n=300) 0.83 (0.70-0.99); p=0.0199 c
KEYTRUDA in Combination with
Chemotherapy
PD-L1 CPS ≥20 (n=126) vs. EXTREME (n=110) 0.60 (0.45–0.82); p=0.0004 a
PD-L1 CPS ≥1 (n=242) vs. EXTREME (n=235) 0.65 (0.53–0.80); p<0.0001 a
Total Population (n=281) vs. EXTREME (n=278) 0.72 (0.60-0.87) b
a Superiority demonstrated.
b No new statistical testing performed because population previously demonstrated superiority at interim analysis.
c Superiority not demonstrated.
The secondary endpoint of ORR was 42.9% for KEYTRUDA in combination with chemotherapy in patients whose tumors expressed PD-L1 with CPS ≥20 compared with 38.2% for the EXTREME regimen. The ORR was 36.4% in patients whose tumors expressed PD-L1 with CPS ≥1 for KEYTRUDA in combination with chemotherapy compared with 35.7% for the EXTREME regimen. The median DOR was 7.1 months (range, 2.1+ to 39.0+) for KEYTRUDA in combination with chemotherapy in patients whose tumors expressed PD-L1 with CPS ≥20 compared with 4.2 months (range, 1.2+ to 31.5+) for the EXTREME regimen. The median DOR was 6.7 months (range, 1.6+ to 39.0+) for KEYTRUDA in combination with chemotherapy in patients whose tumors expressed PD-L1 with CPS ≥1 compared with 4.3 months (range, 1.2+ to 31.5+) for the EXTREME regimen.
In the KEYTRUDA monotherapy arm, an analysis of the total patient population showed an ORR of 16.9% compared with 36.0% for the EXTREME regimen; the median DOR was 22.6 months (range, 1.5+ to 43.0+) compared with 4.5 months (range, 1.2+ to 38.7+) for the EXTREME regimen.
As previously reported, there were no new safety concerns identified with the use of KEYTRUDA in KEYNOTE-048. Grade 3-5 all-cause adverse events occurred in 54.7%, 85.1% and 83.3% of patients in the KEYTRUDA monotherapy, KEYTRUDA in combination with chemotherapy and EXTREME regimen arms, respectively. Adverse events resulting in discontinuation occurred in 12.0%, 32.6% and 27.5% of patients in the KEYTRUDA monotherapy, KEYTRUDA in combination with chemotherapy and EXTREME regimen arms, respectively. Treatment-related deaths occurred in 1.0%, 4.0% and 2.8% of patients in the KEYTRUDA monotherapy, KEYTRUDA in combination with chemotherapy and EXTREME regimen arms, respectively. Grade 3-5 immune-mediated or infusion reactions occurred in 7.0%, 5.4% and 10.5% of patients in the KEYTRUDA monotherapy, KEYTRUDA in combination with chemotherapy and EXTREME regimen arms, respectively.
Additional Information About KEYNOTE-048
KEYNOTE-048 enrolled 882 patients with recurrent or metastatic HNSCC who were randomized to one of three regimens as first-line therapy, as follows:
KEYTRUDA monotherapy (200 mg fixed dosed every three weeks [Q3W]) for up to 24 months (n=301); or
KEYTRUDA (200 mg fixed dose Q3W) in combination with cisplatin (100 mg/m 2 IV Q3W) or carboplatin (AUC 5 IV Q3W) plus 5-FU (1000 mg/m 2 /day IV continuous from Day 1-4 Q3W (maximum six cycles), followed by additional KEYTRUDA monotherapy maintenance therapy until progression of disease, toxicity or until the patient had received a maximum of 24 months total treatment (n=281); or
EXTREME regimen including cetuximab at a loading dose (400 mg/m 2 IV) followed by weekly doses (250 mg/m 2 IV) in combination with cisplatin (100 mg/m 2 IV Q3W) or carboplatin (AUC 5 IV Q3W) plus 5-FU (1000 mg/m 2 /day IV) continuous from Day 1-4 Q3W (maximum six cycles), followed by additional cetuximab monotherapy maintenance therapy until progression of disease or toxicity (n=300).
About Head and Neck Cancer
Head and neck cancer describes a number of different tumors that develop in or around the throat, larynx, nose, sinuses and mouth. Most head and neck cancers are squamous cell carcinomas that begin in the flat, squamous cells that make up the thin surface layer of the structures in the head and neck. Two substances that greatly increase the risk of developing head and neck cancer are tobacco and alcohol. It is estimated that there were more than 887,000 new cases of head and neck cancer diagnosed and over 453,000 deaths from the disease worldwide in 2018. In the U.S. alone, it is estimated that there will be more than 65,000 new cases of head and neck cancer diagnosed and over 14,000 deaths from the disease in 2019.
Yeah, we know that. Ken had to cancel his Danube River cruise early this month. He's busting his a$$ trying to make us rich. To da moon!
Brand new multi-year low of 2.71 (0.18 pre-split). Wow.
Time is money, we are running out of both. The silence from the company is deafening. How low the headcount is now? Under 40? The company reminisces a star ship abandoned by the crew. The "tourists" are left alone to suffocate once the O2 runs out. Welcome to the Get-Rich-Quick space travel agency!
Investigator Sponsored Trial will attract no upfront money, and is another way of quietly shelving the program. At least, it will not drain any resources. Thus, that IST if it were to happen will be a non-event.
Advaxis has been unable to sign any paying partner for too long and that's the problem. NEO/HOT/AXAL/PSA -- why no one wants to commit any money?
Advaxis cash and cash equivalents:
$32.7 as of 1/31/19
Added $9.1M after the most recent secondary
Estimated cash and cash equivalents as on today: $30.3M (assuming $11.5M/Q cash burn rate). Note the market cap is $23.5M.
They will need another raise within 60 days. No way they can raise more than $5M without a total collapse of the share price.
Monday morning tidbit:
PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc. (NASDAQ: ADXS), Advaxis announces Shred Day to be held this Friday, May 31, 2019 at 9am in the GhostTwon, formerly known as the Manufacturing Facility. The company will be shredding 5 volumes of the Term Sheets, previous collaboration documents, proxy votes, and other compensation documents. The ceremony will be open to the general public, and the legacy shareholders are strongly encouraged to attend.
Maybe, Sean E. Harper, former EVP of Amgen and currently a managing partner at Westlake Village Biopartners, can extend funds to ADXS to support NEO program if he was so confident 3 years ago to sign a deal with Advaxis?
http://westlakebio.com/team/sean-harper/
You should know very well that Ph3 and EU submission were two separate things. Phase 3 trial to see how AXAL works as the adjuvant therapy, while Phase 2 was completed as a late stage cancer drug. EU submission was based on Ph2 data plus some other older data. The management decided the data was sufficient to get a conditional approval in EU. Wrong. They should have known that, and they had no clue. Reckless and incompetent. Wasted a lot of time, resources and cash on nothing burger.
Even if the FDA approves the SPA for Aim2Cerv trial to allow for an interim readout or smaller enrollment (lower p-value), we are still at least 2 years away from a possible interim read-out. Current timelines are as follows:
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : October 2024
The company won't be able to survive that long without a cash influx of at least $80M. Yes, they can decide to sell/partner the cervical program, but could they? So far, there have been no takers. The SPA modification approval will not little to this stock. We could get a pop that would fade by the end of the trading day. Unless they sell this program, it will be a drag and a cash burner. They really need to partner HOT and repartner NEO -- that should be their priority. I do not see any urgency, or any life left in this company. Slow death by thousands of cuts. We all made mistake buying in into this pump.