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The Hold is nowhere close to be lifted. Phukc! As announced at the time, Advaxis began working closely with the site investigator, its partner AstraZeneca and the FDA to review this event in detail and to resolve this clinical hold. Several external experts from prominent institutions were also consulted in the process.
Advaxis plans to submit a response to the FDA shortly, and expects to receive a response from the Agency within 30 days after the submission.
What the hell Tony the Dealmaker was doing for almost 9 months? This just sucks.
At least they cut some head count and the cash burn will now be reduced to $12.5M per quarter, down from $20.5M.
It's going to be a wild ride today, buckle up, folks!
Advaxis has decided to reduce internal investment in axalimogene filolisbac (AXAL) and will seek partnership opportunities for AXAL in most human papillomavirus (HPV)-associated cancers, including cervical cancer. If the company is unable to secure a partner within a limited period of time, Advaxis will wind down the ongoing AIM2CERV trial in high-risk locally advanced cervical cancer, and will not conduct the ADVANCE PD-1 combination trial in metastatic cervical cancer, which has not yet been initiated. Advaxis has determined to focus future development efforts for AXAL on HPV-positive head-and-neck cancer through cost-effective clinical studies that are currently being explored.
Wow! AIM2CERV will be canned, and a combo with BMY is not going anywhere!
Geezus!
Advaxis Announces Prioritization Of Product Portfolio And Reports Fiscal 2018 Second Quarter Financial Results
June 7, 2018
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Annual cash burn will be reduced to approximately $50 million from approximately $80 million through a combination of portfolio rationalization and headcount reduction
Conference call begins today at 11:00 a.m. Eastern time
"Coupled with the addition of Executive Vice President and Chief Medical Officer Dr. Andres Gutierrez, we now have the team in place to drive the company forward."
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 a new prioritization of its product portfolio, as well as financial results and business highlights for the three months ended April 30, 2018.
The product portfolio review was conducted under the leadership of recently appointed President and CEO Ken Berlin, along with the full Advaxis executive team including recently named Chief Medical Officer Andres Gutierrez, M.D., Ph.D. The process reflects a commitment to allocate capital to programs that meet three criteria: (i) commercially attractive applications for the company’s Lm technology platform, (ii) the opportunity for the Lm platform to meaningfully impact cancer care, and (iii) a rapid and cost-effective route to generate clinical and immunological response data to demonstrate proof of concept. Each portfolio program was reviewed to determine whether Advaxis can create more value by developing the program internally or externally.
Advaxis has decided to reduce internal investment in axalimogene filolisbac (AXAL) and will seek partnership opportunities for AXAL in most human papillomavirus (HPV)-associated cancers, including cervical cancer. If the company is unable to secure a partner within a limited period of time, Advaxis will wind down the ongoing AIM2CERV trial in high-risk locally advanced cervical cancer, and will not conduct the ADVANCE PD-1 combination trial in metastatic cervical cancer, which has not yet been initiated. Advaxis has determined to focus future development efforts for AXAL on HPV-positive head-and-neck cancer through cost-effective clinical studies that are currently being explored.
Data were presented on the ADXS-PSA combination trial with KEYTRUDA® on June 2nd at ASCO 2018. These data, while early, have proven worthy of further evaluation and the company will continue to follow patients for the next six to nine months in order to determine the path forward.
Advaxis has also decided to increase internal investment in the ADXS-NEO and ADXS-HOT programs, both of which target neoantigens, a potentially transformational, next-generation approach to treating cancer.
Both the ADXS-NEO and the ADXS-HOT programs aim to instruct T cells to selectively attack neoantigens and, in the case of ADXS-HOT, against other tumor-associated antigens, with the goal of controlling tumor growth and prolonging life. Advaxis’ proprietary Lm platform uniquely positions the company in the development of advanced T cell therapeutics compared with other approaches. This belief is based on, among other things, data derived from more than 530 patients treated with AXAL and other product candidates, showing a manageable safety profile, induction of immune responses and clinical activity.
Clinical Hold Update
In March 2018 the company received notification from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for its Phase 1/2 combination study of AXAL with durvalumab for the treatment of patients with advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head-and-neck cancer was placed on clinical hold due to the death of a trial subject that involved pulmonary toxicity occurring after nine months of therapy.
As announced at the time, Advaxis began working closely with the site investigator, its partner AstraZeneca and the FDA to review this event in detail and to resolve this clinical hold. Several external experts from prominent institutions were also consulted in the process.
Advaxis plans to submit a response to the FDA shortly, and expects to receive a response from the Agency within 30 days after the submission.
Management Commentary
“Everything we are striving to accomplish depends on focus and optimal allocation of resources, and is designed to maximize shareholder value. We are dedicating more resources to the HOT program because these assets scored very high when we conducted our portfolio review,” said Mr. Berlin. “This program, along with our NEO program which is partnered with Amgen, hold great potential in the exciting and fast-developing field of neoantigens and have application across multiple tumor types in high-value indications. Therefore, it is important for us to allocate increased resources to realize the potential of these programs and to allow for more rapid advancement in this competitive field.”
“Our new approach is based on a simple reality: While we are fortunate to have a robust product pipeline, we cannot continue to pursue all programs with our current level of resources. We continue to believe in HPV as a target, and are evaluating cost-effective studies for AXAL in head-and-neck cancer. We hope to secure a partner to continue the development of AXAL in cervical cancer,” he added.
“In addition, we are pleased to have completed the buildout of our executive leadership team with yesterday’s announcement that Molly Henderson has joined Advaxis as Executive Vice President and Chief Financial Officer,” he continued. “Coupled with the addition of Executive Vice President and Chief Medical Officer Dr. Andres Gutierrez, we now have the team in place to drive the company forward.”
Corporate Restructuring and Impact on Operating Expenses
As part of the change in strategic direction, Advaxis will implement a reduction in force, effective today, to align staffing levels with development priorities. The workforce reduction involves the elimination of approximately 24% of the company’s workforce. Advaxis will take a one-time charge in the fiscal third quarter related to this restructuring of approximately $905,000. The elimination of these positions in conjunction with reductions in clinical expenditures will significantly lower operating expenses, allowing the company to focus on priority programs.
Reflecting the product portfolio prioritization and workforce reduction, Advaxis expects that its annual cash burn will be approximately $50 million, down 38% from its prior annual cash burn of approximately $80 million.
Financial Highlights for Second Quarter Fiscal Year 2018
The net loss for the second quarter ended April 30, 2018 was $13.4 million or $0.27 per share based on 49.9 million shares outstanding. This compares with a net loss for the second quarter of fiscal year 2017 of $20.5 million or $0.51 per share based on 40.3 million shares outstanding.
Research and development expenses for the second quarter of fiscal year 2018 were $10.8 million, compared with $16.3 million for the second quarter of fiscal year 2017. The decrease is primarily attributable to a decrease in laboratory costs, drug manufacturing process validation and drug stability studies supporting the MAA, which was filed in February 2018.
General and administrative expenses for the second quarter of fiscal year 2018 were $4.5 million, compared with $7.8 million for the second quarter of fiscal year 2017. The decrease was largely attributable to the elimination of non-cash stock-based compensation paid to consultants.
Balance Sheet Highlights
As of April 30, 2018, the company had $58.8 million in cash, restricted cash, cash equivalents and short-term investment securities on its balance sheet. The company has completed a thorough analysis of operating expenses and its research and development programs. As a result, the company has announced a workforce reduction effective June 7, 2018, and is in the process of making further cost-reduction decisions regarding select ongoing clinical trials. Based upon these actions, the company believes its cash position as of today is sufficient to fund operations for at least one year.
Conference Call and Webcast Information
Advaxis’ senior management will host a conference call to review the content of this news release and answer questions. The conference call and live audio webcast will begin today at 11:00 a.m. Eastern time.
To access the conference call please dial (domestic) (844) 348-6133 or (631) 485-4564 (international) and refer to conference ID 8975538. A live and archived audio webcast of the call will be available on the Company’s website at ir.advaxis.com/events-presentations .
For those unable to participate in the live conference call or webcast, a digital recording will be available beginning two hours after the conference call ends. To access the recording, dial (855) 859-2056 or (404) 537-3406 and provide the operator with the conference ID: 8975538. In addition, the audio webcast will be archived on the Company’s website for a period of time at ir.advaxis.com/events-presentations.
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 ability of our product candidates to successfully perform in clinical trials; our ability to initiate 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.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.
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
I find it rather strange that no 10-Q was filed by now. Looks like to significant, tangible news today to report. Just another day in Paradixis.
It could be well possible that the asking price was too high, but Advaxis made deals before that were not beneficial to the company. Over-correcting now by over-pricing? Who knows, we are not privy to that insider information. We are left to wonder why no deals happened, that's for sure.
I know you were in Ziopharm at some point, and you should know that Dr Cooper has been talking about deals and partnerships for three years now, and nothing came to fruition. No deals, just hot air: Everyone talks to us, and we talk to everyone. In the end, money talks, bullshit walks.
Post ASCO, it's pretty much a consensus that MERCK appears a clear winner with Keytruda, while BMY lags with Opdivo.
My opinion would be ADXS needs to review a deal with BMY as it goes nowhere due to a lack of resources: Phase 3 trial is very expensive to run, BMY has no financial skin in the game just a supply of free Opdivo. If the deal cannot be re-negotiated to include a financial terms with BMY, then it should be scrapped or run as P1/2 trial on much smaller sizes (even that is now a luxury for ADXS). In the latter case, the management team must consider negotiating a deal with MRK to include not just PSA, but cervical as well. Can they pull this off?
It’s a mystery why no deals recently.
They could have done both simultaneously. Some companies I know of have raised lots of cash recently, and they are all set for at least 4 more years. Meanwhile, they continue "exploring" deals in the bio space.
Heavily relying on a cash infusion from the possible deals has hurt this company badly if that's the case. Is the leadership that myopic at Advaxis? Maybe, as they not only miscalculated the need for cash, but also continue to keep the cash burn rate at high, unsustainable levels given the balance sheet.
they should have done it a year ago.
But I disagree that TODAY'S share price means one lick for anything.
She gets a 250,000 stock options before she even starts. Wow, it's easy to be so generous on the backs of the long suffering shareholders. Great start!
Most of her career, Molly Henderson worked as a CFO and SVP of VirtualScopics (11+ years) a boutique firm that was in the business of clinical trial imaging solutions which was acquired by BioTelemetry for $15.5M in 2016 -- 2.5 years after she left her job for Iovance Biotherapeutics. She was a CFO for IOVA for just over a year, and left (?) the company when their HQ relocated from NYC to CA. The stock price was stagnant during her tenure, and it tripled since then.
She was a principal financial and business consultant at Cedar Cliff LLC, and I am not sure about that company. The info I got is the company has only 2 employees (which may not be true), and their business has nothing to do with bios. So, not sure what to say about this hire. She looks qualified, but so was SB. What bothers me is she has a very little exposure to finance management for small biotech companies and raising monies for them. We shall see how she performs.
Day 89 of the Hold and counting.
Sigh...
As for tomorrow... I wish I could say my expectations are high for the corporate update, but, I think the markets are saying there'll be nothing of a substance to report for Ken. If a nothing burger is served tomorrow, we will break the all time lows and will head towards a buck per share. I only hope Ken has something in his sleeves.
Nektar and BMY signed a huge deal few months ago that included $1.85B upfront and $1.78B in milestones. NKTR shares plunged 45% after they published underwhelming P1/2 data in combo:
https://www.marketwatch.com/story/do-nektars-disappointing-clinical-trial-results-invalidate-2-billion-bristol-myers-deal-2018-06-04
This shows how big pharma can screw things up by pouring billions into one of the companies. Would they have been smarter by allocating monies into few companies rather than betting on a single horse?
Will they do a deal with Advaxis after this massive mistake? They got burned badly. We shall see.
James,
Yes, the most recent 10Q states they “have cash to operate into calendar Q2/2019”, while three months before the stated “into 2019 financial year”, which starts 11/1/2018. This is after they raised $18.8M last February. Something doesn’t add up between two statements as their cash burn is $20.5M, and I think calendar year was meant a financial year. Again, it’s just a forward looking statement made by former CEO and CEO.
You can do math yourself. I bet you have degree higher than my GED.
@wmtgreeter
Amgen milestone payment is an unknown right now, and yes, it would be great to get some cash, but I don’t expect it to be over $10M, so this is an extra 1.5 months of operations.
Axal deal will not likely bring any upfront cash for Europe only deal, they could expand it for US and then, maybe some cash. Rampup will be slow, so revenues are likely not until 2020. It’s more symbolic milestone rather than a financial one. The company will have an approved drug, that’s a lot by itself.
ATM is a dilution, you know that, right? How it is any better than a secondary. Care to explain?
The cash burn rate used to be higher than the last reported $20.5M rate. This is after what Tony said “controlling the expenses” or whatever term he used. Charge ups were high due to preparations for EU submission, payments to departed DOC and other incentives for those who still do an excellent job at Advaxis. There are no signs of slowing the cash burn rate. Not yet.
I beg to disagree. As of 1/31/18 (last 10Q filling) they has cash and cash equivalents close to $58MM. They got $18.8M via a secondary. With a cash burn of $20.5M per quarter, they should have about $60M as of 4/30/18 and close to $53M now. This would last for about 7.5 months, or approximately until Mid January ‘19. Do you want to see the run completely on empty tanks? It’s a rule of thumb any public company to have at least 6-months worth of cash. If lower, all warning signs would go off. Unless they expect an approval to come before December or sign a partner for cervical by then to load up coffers, then they can take a chance. Otherwise, the Wall Street will punish them severely.
Do you see flaws here?
If and when EU approval happens, we don’t know. Maybe, it happens in 6 months, maybe in 10 months. Regardless, Advaxis needs to survive until that happens. They are running out of cash faster than the EU approval timeline. The immediate cash needs must be addressed in the interim. Any dilution at these share price levels would be at 35% to 45% discount, and will drop the share price sub $1 with a market cap taking a hit and plummeting to $50MM. It would make things a lot worse than what we have now. Dilution now could be a last nail in the coffin. Do you disagree?
I am assuming it takes time to work out such a deal. Ken has been a CEO for 6 weeks, and if Tony was in talks with Merck before Ken’s arrival, then it’s about time to ink that deal. Thus, I put just 40% chance on that to occur. Still pretty high, but not a slam dunk.
What’s the probability of inking a cash deal with Merck this June?
I’d say it is about 40% given the PSA data. Pretty high chances if Ken plays it right. If not? He still can sell a HER2 franchise, or ink a deal for HOT. I’d give about 20% and 70% probabilities to the former and the latter, respectively, that Ken could partner these for a cash deal. Overall, it’s a good chance Advaxis does not need to dilute here, but, everything is on the table. If Ken cannot ink a single deal with a upfront cash, then he will have no choice but do a secondary. He doesn’t have much skin in the game, so he’ll use 40MM extra shares to raise a cash in order to keep the company running. It’s much less painful for him than for the legacy shareholders. I hope he avoids this scenario, but he’ll do whatever needs to be done. It’s already authorized. June will be a critical month for all of us.
One more thing. Wanted to check if Ken signed any deals/partnerships while at Rosetta Genomics, and to see how much money has he attracted from funds or raised via the secondaries. No such luck, as their web site is down. Not sure for how long, or when it's going to be up, if ever. Don't have time to go through the SEC filings -- me shift to start soon.
@wmtgreeter
It summarized all the Ken's accomplishments while running the Rosetta ship for almost 9 years. He literally run that company to the ground, and it's all on him regardless what other folks say about failed micro RNS biomarkers technology that Ken was trying to commercialize for cancer tests. Something did not work, and Ken either failed to see it or failed to acknowledge. Padded his pockets in doing so. Not a good omen.
Ken's previous company is falling apart, threatening to file for a bankruptcy. Old skeletons are walking out of the Rosetta's closet. Wow!
https://www.genomeweb.com/molecular-diagnostics/rosetta-genomics-dispute-genoptix-places-pending-merger-jeopardy#.WxWIpO4vwkI
Rosetta Genomics Dispute With Genoptix Places Pending Merger in Jeopardy
May 30, 2018 | staff reporter
NEW YORK (GenomeWeb) – Rosetta Genomics said today that its previously announced merger with Genoptix may not occur due to a dispute between the companies.
If the transaction is not completed by the end of the day, Rosetta said it intends to file for bankruptcy protection in the US and Israel where it maintains operations.
In late 2017, Genoptix agreed to acquire Rosetta for $10 million in cash, but the deal was scuttled earlier this year after failing to generate enough support from Rosetta's shareholders. Shortly thereafter, the companies signed a new merger agreement — which valued Rosetta at $9 million — that was ultimately approved by Rosetta's shareholders.
While that new deal was supposed to close on May 27, Rosetta disclosed today that Genoptix has "refused to provide assurances that it intends to complete the transaction" due to an undisclosed "material adverse effect" affecting Rosetta, as well as breaches of representations and warranties.
These issues would eliminate Genoptix's obligation to complete the merger, though Rosetta said it disputes them.
Based on the stock behavior in the past few days, I would suggest that there'll be no positive surprises this Thursday. No signs of a deal, no NEO update, and no clarifications about cash runway. Have they been able to reduce a cash burn from $20.5M per last Q to, say, down to $15M?
Tony, the Dealmaker, warmed the bench for 9 months, and hasn't produced a sheet. What a disaster.
I will consider selling and taking enormous losses if nothing of substance happens before the end of September. What about you? Will you still be beatching about DOC and his greed?
Re-read my post. Reading comprehension issues, Barnie?
The last update was on 3/15/18. It could be a start of recruitment, but can't be sure. We shall see if they update us on the NEO status or not.
https://clinicaltrials.gov/ct2/show/NCT03265080?term=advaxis&draw=1&rank=1
Day 87 of the Hold with no signs of lifting it. It's just got so ridiculous, I simply can't find any excuses.
This is a critical week for ADXS due to a business update. The cash issue will be a single most important issue. Depending on how KB is going to address that we will see a change in the share price direction. If he avoids conversation about replenishing cash vault in the near term, we will tank. If he outlines ways to get that issue resolved without a disastrous dilution, then we go up quickly.
So, what say you, Ken?
Therein lies a dilemma for this PSA trial continuation: who’s is going to pay for Phase 3 to run? Obviously, Advaxis cannot afford to run such an expensive trial, Merck has the money but do they see the data compelling enough to support the trial? Will they sign a deal with ADVAXIS to infuse large cash? If not, we will see this die as a withered flower. Ditto for a BMY combo trial that was supposed to jump into Phase 3 for cervical. ADXS DUAL needs lot of cash to run, and the current deal has no financial ramifications for Bristol-Myers, it’s all on a small brother, i.e. us. Who was bright enough to sign that deal? Even a GED holder can see huge holes in that deal, but PhDs and JDs can’t? Albeit my IQ is barely above a water solidification temperature, I wouldn’t sign that deal.
“History repeats itself, first as a tragedy, next as a farce”, a quote by Karl Marx.
You don’t need to read “Das Kapital” or be a Communist to agree that no one wants to see Advaxis redux as a farce. I don’t want us to jump from a tragedy directly into the grips of a tragedy. Do you?
The company burns 15 million a Qtr.
It's significantly higher, their cash burn was $20.5MM last quarter with little to no signs of slowing down.
Edelman likely took a flyer on ADXS as it's just less than 0.1% of his total portfolio. I would not be surprised if he dumps all his shares by the end of Q2. Alternatively, if he increases his stake to file F4, then I'm taking that seriously. Otherwise, he might not know more than most of the long struggling ADXS shareholders. This company is as transparent as flush flood waters.
1) Most of the original patents are the property of Dr Yvonne Patterson. She licensed the technology to Advaxis. Only recent patents are the company's property. Thus, IP mostly belongs to UPenn via Dr Patterson.
2)After a long run up? What run up was it? Is 2021 already here? A guest from the future?
ASCO PR is out, and another yawn from the markets. Measly volume, just under 35K shares traded within 90 minutes.
Ken needs to get a deal done.
The biggest confirmation would be if ADXS and MRK ink a deal soon. Hope it would include a substantial upfront money and a large stake buy-in by Merck. Ken needs to complete this deal ASAP.
I am afraid you are wrong about the share price reaction on the lukewarm business update. Every business update so far has resulted in at least a 5% to 10% haircut within few days except for the last year when we dropped like a rock. Why this time it would be different? The possibility of a massive dilution would be much higher if no clear path to avoid dilution is outlined, or any milestone payment is reported, or an imminent cash inflow through the licensing is not suggested. We still have almost 7% short interest and they will not be sitting there and watching. What if large funds decide to lighten up in an absence of a real catalyst within few months? I hope we will not see an over-reaction, but we might break our 52-week low. Once again. This is avoidable if Ken Berlin delivers something tangible. I'd hate to see if Tony's tenure was a complete bust.
Can we repeat a MDGL story? Today, the stock is currently up 144%. It was around $15 at the end of August '17. Now it's $264, almost 18-fold increase in 9 months. Granted, the stock collapsed to $15 area from the current levels. They changed CEO almost 2 years ago, and look now!
I'd be happy to see if Ken turns this clunker around, not expecting a MDGL-like miracle.