CALENDAR UPDATE (February 7, 2018)
New additions in red
found further below.
March 7, 2017 -- About 3 million in loans received -- due in 6 months (+ interest) or sooner. Changes in this post made after reading "refinements" from Jerry.
March 17 -- 7.5 (Effectively 6.7 million after expenses according to Jerry) million raise. (Closed on March 22nd)
March 27 -- DCVax Advanced Method (aka: B+(?)) International Publication Date of International Patent Application for "METHODS RELATING TO ACTIVATED DENDRITIC CELL COMPOSITIONS AND IMMUNOTHERAPEUTIC TREATMENTS FOR SUBJECTS WITH ADVANCED CANCERS" -- DD Courtesy of Smokey
March 28 -- Yonemura v. Powers recorded conference call. (Stayed to July 28 for "final resolution")
March 30 -- Last day for companies at ASCO to get any "late breaking abstract" data in.
March 30 -- Dr. Schwartz inaccurately tweets (with glee) NWBO withdrew their NWBO ASCO booths.
March 30/31 -- 6 Cognate jobs (with prior various original posting dates) reposted on Monster.com
March 31 -- Payment by NWBO due -- 500k (or sooner upon request)(paid)
March 31 -- Lerner v. NWBO case dismissed in favor of NWBO. (Approximately 19.3 month old case) (Info: Courtesy of Senti)
April 1, 2017 -- Dr. Prins speaks at AACR conference.
April 3 -- Job listing: Manager, Validation Services at Cognate Bioservices.
April 4 -- Two business days after Lerner suit dismissed and five business days after Yonemura case set for "final resolution" this summer, AF writes hit article against NWBO regarding (no longer existing) partial clinical hold on screening. Additionally, AF criticizes NWBO AACR booth, booth location and Dr. Bosch. Dr. Schwartz also criticizes (and tweets) AACR booth with joy -- claims no one there to answer questions -- Even though AF questioned Dr. Bosch.
April 5 -- India FDA approves autologous dendritic therapy for prostate, ovarian, lung and colorectal cancer. (Info courtesy of ForumReader35)
April 17 --10K filed
April 18 -- Since March 31, five Cognate job postings the listed and/or relisted have either been filled (or simply removed.)
April 19 -- Payment by NWBO due -- 2.3 million (some might be due sooner upon request) (paid).
April19 -- Payment by board (lenders) on 2.3 million through loan financing.
April 19 -- ASCO Titles leaked by ASCO website one day early. http://www.investorvillage.com/smbd.asp?mb=16353&mn=78709&pt=msg&mid=17081359
April 20 -- ASCO titles for Regular and LBA released. No abstracts related to DCVax.
April 24 -- Bear attack, preceded over the weekend by unsubstantiated claim of PFS futility.
April 25 -- Announcement of loan financing by Board members that occurred on April 19, 2017 to pay off 2.3 million in notes owed.
May 5, 2017 -- Since March 31/April 4, seven of seven Cognate job postings listed and/or relisted have either been filled (or perhaps simply removed.)
May 5 -- One million dollar loan (aka: equivalent to six-and-a-half million shares). Due on June 30, 2017. (Due Diligence courtesy of Omair92 & Bioaddict )
May 9 -- Likely final vote on FDA Commissioner confirmation -- Due Diligence courtesy of Sentimentstocks.
May 9 -- Scott Gottlieb confirmed as new FDA Commisioner.
May 10 -- ESMO regular abstract deadline.
May 15 -- Woodford Fund confirms it is still holding NWBO in its Patient Capital Trust portfolio as of April 30, 2017. (Due Diligence Courtesy of TiltMyBrain)
May 15 -- 1st Quarter 10Q filing due. (Due Diligence reminder courtesy of Kabunushi)
May 15 -- 1st Quarter 10Q filed. SentimentStocks pointed out the 10Q notes that NWBO is now moving forward with process validation work.
May 17 -- Regular abstracts released by ASCO
May 17 -- Notice of exempt offering of securities filed with SEC.
May 17 -- UK's NICE confirms developing a guideline on DCVax-L for treating newly diagnosed glioblastoma -- albeit in early stages. Due Diligence Courtesy of CherryTree.
May 20 -- Payment by NWBO due -- 2.5 million (paid)
May 22, 2017 -- Security Purchase Agreement hold on PFS data release lifted.
End of May, or possibly later, rGBM combination trial to initiate. NOW moved to August.
Maybe June or later -- 233 events
June 2-6, 2017-- ASCO. LBAs released
June 5 -- Dr. Marnix Bosch discusses DCVax at ASCO's Industry Expert Theater @ 3:00.
June 5 -- Dr. Marnix Bosch notes currently 231 patient OS events (100 patients still alive), and 233 events expected by mid July 2017. He notes OS eventing is slower than anticipated at this time.
Dr. Bosch also notes Investigators already working on a publication for the DCVax-L trial. Median Length of time patients have been enrolled in the DCVax-L trial is 37 months. Dr. Bosch is preparing for a sarcoma trial for DCVax-Direct soon and plans on incorporating approved checkpoint inhibitors in some DCVax-Direct trials. In the Phase I DCVax-Direct trial, 23% of patients exceeded two years OS, and 18% have exceeded 30 months. In the info arm for DCVax-L, 40% of patients lived past about three years in the indeterminate arm and 24% have lived past four years in the same arm.
June 12 -- SNO (Society for NeuroOncology) regular abstract deadline.
Approx. June 17 -- Deadline to exercise 3 month warrants? Up to $21.6 million cash received (or none at all)
June 20 -- Payment by NWBO due -- 5.5 million (Paid)
June 22 -- Announcement: "This completes the Company's payoff of $11 million in principal amount of bonds, plus associated interest and forbearance fees, over the period from March through June of this year in accordance with an installment payment agreement with the bondholders entered into in March". (Due Diligence by John, and premonition of sorts by JDHeart smile)
June 30 -- Repayment on 1 million dollar loan due.
July 19, 2017 -- LBA deadline ESMO
July 28 -- Yonemura v. Powers, the parties have reached (stipulated to) a settlement, but the court will not convene a hearing for potential approval thereof until October , 2017. This public notice was issued on July 28 in a Federal Court document, even though the settlement stipulation was entered back on May 19, 2017. Due diligence courtesy of Barcode27
August 1, 2017-- No longer Scheduled* start of DCVax-L recurrent GBM combo trial. (*Still has not initiated as of August 8) This scheduled start date was changed to October 1 (change was made on Aust 17) Due Diligence: SBNYC
Aug 1 -- SITC regular abstract deadline.
Aug 5 -- Last screening/recruitment was TWO YEARS (24 months) prior to this date in the phase III DCVax-L trial.
Aug 7 -- 2 recent financings raise approximately 3.7 million dollars, likely increasing the fully diluted share count north of 415 million* (*my estimate.)
August 8 -- additional financial raises. See August 21 for grand totals.
August 21 -- 10Q filed. "As of August 21, 2017, the total number of shares of common stock, par value $0.001 per share, outstanding was 295,253,044." "Potentially Dilutive Securities" 192,778,000 (see page 20) This apparently results in about 488 million fully diluted? NWBO is winding up Cognate manufacturing in Germany and Israel, however, it is continuing to expand Advent Bioservices (formerly named Cognate) manufacturing in the UK. Cognate in the United States has changed its payment arrangement with NWBO whereby it only exacts per patient batch -- without charging for costs such as empty clean rooms during slow times.
August 26 -- Approximately 10 million in warrants expire reducing fully diluted count to about 478 million?
Aug 31 -- August 31, 2017 11:45 Dendritic Cell Immunotherapy for Solid Tumors, Marnix Bosch, Ph.D., CTO, Northwest Biotherapeutics (Due Diligence Courtesy of Forum Redaer)
Sept 2017 -- DCVax-L adjuvant trial estimated trial completion date. (postponed to October 2018) Due Diligence: Exwannabe
Sept 1 -- Late Breaking Abstracts Due for SNO Conference. (Society for NeuroOncology) (Due Diligence courtesy of various posters)
Sept 5 UCLA paper reports significant progress in human and animal imaging studies to distinguish psPD from real progression in GBM. Perhaps more importantly, this imaging technology can also help determine whether there are tumor infiltrating lymphocytes and whether there is lymphocyte activity in peripheral nodes, thereby providing a noninvasive tool to help determine immune response. The human study was conducted in nonresected recurrent tumors. (Note: The phase II DCVax-L monotherapy & combination trial will be in a slightly easier to treat population where recurrent tumors are first resected -- rather than the nonresected recurrent population in the aforementioned pilot study.) (Note: Drugs like Avastin may mask this new imaging technology, but Avastin is more often used in inoperable recurrent cases, which should not be the case for new enrollees in the phase II recurrent GBM trial.) Finally, the pilot study demonstrated there is TIL and peripheral node activity/increase in response to DCVax-L & DCVax-L + Checkpoint Inhibitor -- although Avastin appears to mask TIL activity in humans.
Sept 7 -- Approximately 3 million (+ interest) in loan repayments by NWBO due (or sooner upon request).
Sept 8-12 ESMO Congress
Sept 14 -- SITC late breaking abstract deadline.
Sept 27 -- NWBO presentation at SMI Cancer Vaccine conference has been cancelled per September 25, 2017 8K, because NWBO is "ANTICIPATING DISCLOSURE OF INTERIM BLINDED DATA."
October 1, 2017 (Postponed to January 1, 2018....third postponement) -- start of DCVax-L monotherapy and combo trial with Nivolumab (aka: Opdivio) in Recurrent GBM. Due Diligence: SBNYC
October 17, 2017 -- NWBO lease out 275,000 sq ft building in Sawston, UK for 3.5 to 5 years to a commodity storage and distribution firm domiciled in the UK. Lease Includes Substantial Refurbishment and Approximately $6 Million Revenues Over 5 Years.
October 20, 2017 -- Company conducted small financing to obtain $500,000.00 semolians. Of note was fact that NWBO appeared at or very near the end of its 450 million dollar shelf limit (perhaps currently at 443 million), but NWBO still retains 40 million in preferred shares that are eligible for issuance.
October 25, 2017 -- Company announces four lawsuits against it are in two cases dismissed, and in the other two pending dismissal with no further costs to investors. (A fifth smaller lawsuit (Chardan versus NWBO) demanding 500,000 from NWBO is still outstanding.)
October 27, 2017 -- NWBO filed letter with the Court still pursuing dismissal of Chardan case. Due Diligence: Barcode27
October 31, 2017 -- I'd expect this date to be the latest cutoff for new shares purchased to allow purchaser to vote those shares in any NWBO December 2017 shareholder meeting that might be scheduled. This is purely speculation on my part.
First week of November: 24 months since last patient enrollment. Approximately 27 months since last patient diagnosed. (Source for date initiation: Dr. Marnix Bosch presentation at ASCO on June 5, 2017)
November 1, 2017 -- Cognate increasing job listings. Seven over last month, and four of those added today.
November 3, 2017 deadline for companies wishing to submit late breaking abstract data for December 7-10 ESMO Immuno Oncology conference in Switzerland.
November 3, 2017 Dr. Scott Gottlieb, the commissioner of the Food and Drug Administration, will appear at a National Press Club Headliners Luncheon on Friday, Nov. 3 to discuss the FDA’s agenda and related issues. Livestream will begin at 1:00 pm EST, www.press.org/events/npc-headliners-luncheon-fda-commissioner-dr-scott-gottlieb Due Diligence: Xena and Sentiment
November 8-12 -- NWBO Exhibit (Booth) at Society for Immunotherapy of Cancer conference.
November 13 -- Chardan against NWBO -- Parties inform court they would prefer a settlement conference within the next month. In a separate filing, NWBO confirms no publicly held corporation owns 10% or more of its stock. Due Diligence Courtesy of TCTrader and Barcode.
November 14 -- ASCO starts receiving abstracts for next year's spring conference.
November 14 -- NWBO obtains new registered trademark for DCVAX. Due Diligence: ATLnsider
November 14 - 20 -- NWBO files five day extension request for third quarter report. Due Diligence: Jerry and Hodag.
November 16, 2017
FDA announces comprehensive regenerative medicine policy framework https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585345.htm
and Expedited Programs for Regenerative Medicine Therapies for Serious Conditions https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM585414.pdf
Among other things, allows companies in some cases to pursue Accelerated Approval based upon data from a "significant" number of clinical trial sites. -- Due Diligence courtesy of SentimentStocks.
November 16-19 -- NWBO booth at Society for Neurooncology conference. Due Diligence Courtesy of: Whitewater55
November 23 -- Yonemura case to be dismissed with prejudice. Due Diligence: Sentiment_Stocks and TC_Trader.
November 20 -- 10Q filed. Cognate debt to be paid -- settlement agreement for massive share payment (and cash) from NWBO (most cash apparently via investor financing.) Cognate waived its right to recover half the debt owed. There was agreement as of November 20, but the parties had not completed drafting nor signature as of the Nov 20th filing. NWBO, through Advent, signaled it is preparing for DCVax-L production and negotiating contracts for distribution in Europe and the UK.
November 30, 2017 -- FDA intends to complete guidance that will make early/accelerated approval easier for therapies that qualify by demonstrating very early survival efficacy data in addition to high safety profile. Expected guidance in January 2018.
December 1, 2017 -- As of the date of this update on December 1, 2017 -- The company has not publicly notified investors of any intent to delay previous plan to data lock at about 233 OS, obtain independent analysis and unblind the results. It is assumed by most board members 233OS was already reached sometime in the past -- potentially months ago.
December 1 -- (Senate Tax Bill Vote Likely Today. It ran into snag due to its likelihood of increasing deficit by one trillion dollars over 10 years. Newspapers are now reporting Senate has the votes. The Treasury Department’s inspector general is examining whether political considerations interfered with Secretary Steven Mnuchin’s promised analysis of the Republican tax proposal. No longer November 20 -24 -- Republican previous goal for Senate passing tax bill including tax repatriation. Any law passed on tax repatriations could have major impact on accelerating M&A in biotech.)
December 2017 -- ASM? (No ASM scheduled in December)
December 5-7, 2017 IMMUNOTHERAPY Progress and Clinical Treatments Making an
IMPACT on the Next Generation of Immunotherapy | San Diego, CA (It appears from work done by the Ihub board that Dr. Boynton was scheduled to present on December 6th on an unknown topic; however, it appears he has fully withdrawn, and it appears an unrelated speaker now has that time slot. Due Diligence: ATLnsider, Barunuuk and other board members.
December 7-10 ESMO Immuno Oncology conference in Switzerland.
December 15 -- Congress hopes to have tax reform bill on President's desk. (If passed, this likely means large pharma would have additional repatriation funds for M&A of smaller companies)
December 19 -- Regulation D offering for accredited investors (likely taking fully diluted share count to approximately [900 million] shares -- however, it should be mentioned the lion's share are closely held)
December 20 -- Tax Bill has passed both houses.
December 22 -- Tax Bill signed into law. Big Pharma will repatriate billions and billions. This may start a M&A spree during 2018.
January 1, 2018 -- (Did not occur as of February 7, 2018. Appears NWBO will await DCVax-L Phase III trial data before moving forward.)
Previously scheduled start of DCVax-L monotherapy and combo trial with Nivolumab (aka: Opdivio) in Recurrent GBM (Nothing official has been announced as of January 3.)
January 3, 2018 -- Wells versus Powers dismissed (leaving only Chardan v. NWBO -- an inconsequential case) For all practical purposes, all meaningful outstanding lawsuits dismissed on or before today. January 16, 2018 -- Option grants to named Executive Officers and Employees.
January 21, 2018, 1:00 a.m. Deadline for proxy vote. 1:30 p.m. Annual Shareholder Meeting.
January 21, 2018, Annual Shareholder Meeting held. Reports from attendees seemed to confirm a manuscript submission was submitted for publication to a specific journal in the Autumn of 2017, and it includes input from 65 coauthors. The Journal apparently cannot be named prior to publication. NWBO was not specific regarding data lock timing, (but it is my sense their evasiveness has to do with the delayed publication of blinded data.) Cofer Black, who is on the Board of Directors was at the meeting, and an attendee relayed:
"Cofer Black said that he was “appalled” by the level of attack NWBO has experienced and is collecting data and insights to operationalize a response of some kind. Very vague as to what that would mean. Cards close to the vest.... His comment also included something to the effect of “we need to operationalize the information we have so that shareholders can be appropriately compensated for their patience. It wasn’t “compensated” but a word like that, which I can’t remember." Courtesy Rogers5729
barcode27 Member Profile barcode27 Sunday, January 21, 2018
Sunday, January 21, 2018 8:39:16 PM
Re: None Post # of 155597
LP on the paper to be published:
When we made the announcement at ASCO, that was the beginning of the publication pathway. If you're familiar with top-tier scientific journals, it's not unusual for it to take 6-7-8-9 months. What I can tell you is that we worked on it the whole summer, including together with the doctors who are the investigators in the trial. Some 65 doctors all wanted to be co-authors on the paper, and we had to work through the process with all of them, and all of them reviewing the manuscript. The manuscript was only actually submitted in the fall, so we're only a couple of months into that process. We feel good about the process, but we don't control the timeline of the process. We're just as anxious as you are for the damn thing to get out, but we have to be patient.
This paper is about the interim blinded data. What we don't know, and what we're in fact not allowed to know, is the unblinded data. We can only see the aggregate total data from all the patients in the trial. We don't know the difference between the patients who got the DCVax to start with, which was 2/3 of the patients, or the patients who got a placebo to start with. The other things that's really important to know, is that the way our trial was designed, is that a patient would get assigned to a treatment group at the beginning, either SOC + DCVax or SOC + placebo. But then, when they had tumor recurrence, progression, everybody was allowed to get DCVax after that, and everybody still stayed blinded. We don't know, that patients don't know, the doctors don't know, what was in the syringe before their tumor progression. After progression, then we know everybody can get DCVax, and as we've reported publicly, nearly 90% of patients have now gotten DCVax, either initially, or after the crossover. So, the data is relevant and interesting to look at because basically 90% of the patients in the trial have gotten DCVax. So that's how we can write a publication about it.
We can't talk about the paper or present it at conferences. If we talk about it, a journal will not publish it. (Les) - We did say some things at ASCO that relate to some of the metrics of what Linda just described, and that is public information.
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NorthWest Biotherapeutics Inc. (NWBO)
barcode27 Member Profile barcode27 Sunday, January 21, 2018 7:36:15 PM
Re: None Post # of 155597
LP on the long tail:
The 233 OS events is not an automatic trigger, it's a floor, and we wouldn't unblind before that. But there's nothing that says we would automatically stop then. What we do is, we look, and all we're allowed to see is blinded data, so we're looking at aggregate blinded data. In immunotherapy, the big focus is the so-called long tail of the survival curve. That is the home run. And what it means to have the long tail, is that the survival steps down, and when people continue to live, the tail goes way out here to the right. If a treatment achieves a long tail, that's the home run. I mean, part of it is the slope of the graph, that's great too. But the big home run is the long tail. And you're seeing that being talked about with all of these therapies... with checkpoint inhibitors, everyone is super-excited because something like anywhere from 12 to 20% of the patients who respond in the first place are in a long tail and go for a couple of years. What people don't generally clarify is that even in the best case of cancers like melanoma where you're talking about a 25% response rate, you're talking about 25% of the 25%, talking about like 5% of the total participants in the trial. If some treatment were to come along and have 20 to 25% of the total patients in the trial, that would be considered a very large tail, and the question is how big and how long. That's what we want to see, and that's what you as shareholders should want to see. We share your anxiousness like it's Christmas morning. But when we stop the trial and unblind, the data collection for the purposes of the trial stops. After that, we will never know the full extent of the long tail. The long tail is the key focus.
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NorthWest Biotherapeutics Inc. (NWBO)
barcode27 Member Profile barcode27 Sunday, January 21, 2018 7:06:55 PM
Re: Poor Man - post# 154832 Post # of 155597
And Linda's additional follow-up on this topic (Cognate):
We've been the beneficiary of going for months and even years without paying for work being done. None of our other service providers would do that. Our CRO that manages the trial, if we pay them more than 10 days late for one month, they'll stop the trial. So, we've been the beneficiary of all of our products being made when we need them, and long long periods of time without paying the bills at all, then when we did pay, we paid in partly in stock and partly in cash, then we took that stock back again (laugh), with the NASDAQ settlement, and we had them write off big swaths of the bill. We have not been able to achieve any such treatment from any other service provider from all of the service providers we use.
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NorthWest Biotherapeutics Inc. (NWBO)
barcode27 Member Profile barcode27 Sunday, January 21, 2018 5:52:47 PM
Re: laser777 post# 154792 Post # of 155597
Yes, pretty much verbatim. Note that she went through the usual "forward looking statements" disclaimer before the Q&A started.
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NorthWest Biotherapeutics Inc. (NWBO)
barcode27 Member Profile barcode27 Sunday, January 21, 2018 5:00:05 PM
Re: rogers5729 post# 154755 Post # of 155597
Per LP at the meeting in response to a question regarding when they would stop the trial:
I can't spell out a formula for you. We do periodic data collections. When we do a data collection, it's about a 3 month process to collect an update. The independent CRO sends physical staff to all of the sites. We have some 80 sites in this trial. A breathing, human person looks at the files at each hospital and looks at the numbers and compares them to the central database. The central database is kept by an independent data company that's separate from the CRO. And, by the way, the company (NWBO) doesn't do any of this. That process generates what are called queries. Anything where a piece of data is missing or inconsistent, is a query. A data collection process can generate several thousand queries. All of them have to be resolved. Only then do you have a clean data set from the collection. Once you have a clean collection, then it goes to the independent statisticians who then tabulate it. So you have the CRO making the in person visits, you have the queries getting resolved and the independent data company holding the clean data set, and you have the independent statisticians tabulating it. It takes about three months to do that process. We have done it once each for the last three years. We have not made any announcements about the spring of this year, but, it would be a, uh, reasonable thought that there might be a similar cycle in the spring of this year. And it would be the same process, would take three months or so. As we reported in ASCO last year, a huge number of patients, way more than expected, were still alive. We have to weigh that... how much of an additional home run would we get if we continue vs. going with what we have now.
January 23 -- 10:15 a.m. Miami conference: LP will speak: "Achieving both precision targeting and broad spectrum immunotherapy."
January 24 -- 4:10 p.m. Miami conference: NWBO: "Challenges of heterogeneous solid tumors: targeting broad spectrum of tumor biomarkers while also precision tailoring to the patient"
February 9, 2018 -- The Seattle Science Foundation will be hosting their 3rd Annual Brain Tumor Management event on February 9, 2018. Due Dilgence Courtesy of Sentiment Stocks. February 13, 2018 -- ASCO's regular abstract deadline.
March 15, 2018 -- ASCO's Late Breaking Abstract deadline.
June 1 - June 5 2018 -- ASCO Conference.
Mid June, 2018 -- UK's NICE begins appraisal of DCVax-L
Mid August, 2018 -- Document submission deadline for UK's Nice appraisal of DCVax-L.
(Note: This is my last calendar update until we either get publication of blinded results, topline results and/or BLA information)