Replies to post #136479 on NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

The other upcoming dates are less meaningful now that NWBO has now shown a willingness to cancel a presentation at the last minute.

Once again, this is where clear communication by management on future milestones and some kind of commitment to actually sticking with them would be helpful.

Even the reason for bowing out of this latest conference was so ambiguous as to give rise to extensive debate and gives rise to more questions than answers.

For example, when will that blinded data be released? Even if they cannot give a specific day, they should (by now) be able to give a maximum date by which it would be released and pad the estimate with a little CYA if they need to.

What would blinded data actually consist of and how would it look compared to unblinded data?

Instead, they just leave an 8 ball on the table and expect shareholders to just keep shaking it.

[flipper44]

CALENDAR UPDATE

New additions in red.

March 7 -- 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 -- 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 -- 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 -- 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 -- 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 [31], 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 -- 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 -- DCVax-L adjuvant trial estimated trial completion date.
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 -- Scheduled start of DCVax-L monotherapy and combo trial with Nivolumab (aka: Opdivio) in Recurrent GBM. Due Diligence: SBNYC

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 8-12 -- NWBO Exhibit (Booth) at Society for Immunotherapy of Cancer conference.
November 16-19 -- Society for Neurooncology conference.