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NorthWest Biotherapeutics (NWBO)

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Last Post: 4/21/2015 7:18:13 AM - Followers: 237 - Board type: Free - Posts Today: 11

 Stylized Dendritic Cell

A "personalized brain cancer vaccine, DCVAX, is the first of its  kind and... is on the road to FDA approval."
- Neil A. Martin, Chairman, UCLA Department of Neurosurgery

"Clinical and immunopathological effects following Image-guided intratumoral injection of activated, autologous dendritic cells in patients with advanced solid cancers" - Abstract #2499 - AACR (American Association for Cancer Research)
"Proffered Paper:  Prolonged Survival for Patients with Recurrent Glioblastoma Multiforme who are Treated with Tumor Lysate-Pulsed Autologous Dendritic Cells" - presented at ITOC-Conference, Munich, Germany - March 26, 2015, 14:40 - Marnix Bosch, Chief Technical Officer, NW Bio (note, abstract linked here is from Science Direct)

Corporate Profile

NW Bio is developing cancer vaccines designed to treat a broad range of solid tumor cancers more effectively than current treatments, and without the side effects of chemotherapy drugs.  NW Bio’s proprietary manufacturing technology enables them to produce its personalized vaccine in an efficient, cost-effective manner. NW Bio has a broad platform technology for DCVax dendritic cell-based vaccines.

Their lead product, DCVax-L, is currently in a 348-patient Phase III trial for patients with newly diagnosed Glioblastoma multiforme (GBM), the most aggressive and lethal brain cancer.  This trial is currently underway at 69 locations thoughout the United States, Germany and the United Kingdom. NW Bio has also conducted a Phase I/II trial with DCVax-L for late stage ovarian cancer together with the University of Pennsylvania.

Their second product, DCVax-Direct, is currently in a 60-patient Phase I/II trial for direct injection into all types of inoperable solid tumor cancers, with trials currently being conducted at both MD Anderson Cancer Center in Texas, as well as Orlando Health in Florida.  

 They previously received clearance from the FDA for a 612-patient Phase III trial with its third product, DCVax-Prostate, for late stage prostate cancer.

Clinical Trials
DCVax®-L to Treat Newly Diagnosed GBM Brain Cancer (NCT00045968) - Phase III (Double Blind) 
Expanded Access Protocol for GBM Patients with Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221 (NCT02146066) (Expanded Access)
Safety and Efficacy Study of DCVax-Direct in Solid Tumors (NCT01882946) - Phase I/Phase II (Open Label)
UK Clinical Trials - Study of a Drug (DCVax®-L) to Treat Newly Diagnosed GBM Brain Cancer
EU Clinical Trials for DCVax-L - Phase III

Company Contact Info
Investor Relations:
Les Goldman    (Co.)     (202) 841-7909
Farrell Kramer (Media)  (212) 710-9685 or

Company Headquarters
4800 Montgomery Lane, Suite 800, Bethesda, MD 20814  (240) 497-9024

DCVAX Survival Stories
NWBO - National Geographic's Allan Butler Stage IV Pancreatic Patient using DCVax-Direct at MD Anderson
NWBO GBM Brain Cancer Survival Story of Mark Pace
NWBO GBM Brain Cancer Suvivial Story of Brad Silver
NWBO, GBM Brain Cancer Survival Story of Mike Gregoire
UCLA - Real Stories Using DCVax

Designations & Awards
German Hospital Exemption (referred to as HE) Information for DCVax-L® - FIRST TIME EVER

DCVax-L Hospital Exemption Program Now Under Way in Germany (NWBO, PR Newswire, October 14, 2014)
Two German Approvals:  "Hospital Exemption" for Early Access Program with DCVax-L and Eligibility of DCVax-L for Reimbursement (NWBO, March 10 2104)
Analysis:  NWBO DCVax-L German Approval Under Hospital Exemption Early Access Program (Smith on Stocks, Nasdaq, March 11, 2014)
Exclusive - Germany OKs Northwest Bio Brain Cancer Drug, Shares Soar (Ransdell Pierson, Reuters, March 10, 2014)

United Kingdom Awards DC-Vax-L® as Promising Innovative Medicine (PIM) - FIRST TIME EVER
First UK "Promisting Innovative Medicine" Designation Awarded (Department of Health and George Freeman MP, Gov.UK, September 16, 2014)
NWBO's Cancer Vaccine is the First Drug to be Designated by UK Authorities as a "Promising Innovative Medicine" (PIM) - (NWBO, September 16, 2014)

Immunotherapeutic Niches, Competition and Collaboration (5 Parts)
Part III - Immunotherapeutic Niches, Competition and Collaboration. Immunomodulation - Anti-CTLA-4MAb (Prepared by flipper44, December 2014)
Part II - The Cellular Approach (Prepared by flipper44, November 2014)
Part I - Vaccines  (Prepared by flipper44, November 2014)

Linda Powers Interview 5-15-12

Important or Helpful Links
NWBO Stock Quote & Information
NWBO SEC Filings
NWBO Twitter
NWBO Facebook
NWBO Yahoo Message Board

Upcoming Healthcare Conferences

Institutional Investments
Nearing "the finish line" on cancer vaccine trial, Maryland firm raises $40 million - April 3, 2015 (J.D. Harrison)
Northwest Biotherapeutics:  The $40 Million Woodford Financing is A Major Positive - April 3, 2105 (Smith on Stocks - Larry Smith)

NWBO Analysis
Northwest Biotherapeutics:  Promising New Data Was Just Presented on DCVax-L in Recurrent Glioblastoma Mulitforme - March 27, 2015 (Smith on Stocks - Larry Smith)
Northwest Biotherapeutics:  How Much Will it Cost to Manufacture DcVax-L - March 5, 2015 (Smith on Stocks - Larry Smith)
The Potentially Key Role of Northwest Biotherapeutics in the Emerging Immuno-Oncology - February 3, 2105 (Smith on Stocks - Larry Smith)
Notes from Linda Powers Presentation in San Francisco - January 12, 2015 (Smith on Stocks - Larry Smith)
Current Investment Recommendations for Stocks Covered by SmithOnStocks; A Yearend Review - December 19, 2014 (Smith on Stocks - Larry Smith)
NWBO discussed at great length.
NWBO:  Putting Recent Clinical Data on DCVax Direct in Perspective - November 28, 2014 (Smith on Stocks - Larry Smith)
DCVax-L:  A Reimbursement Perspective - November 22, 2014 (Seeking Alpha - Ryan Pawell)
DCVax-Direct Validation and Updated DCVax-L Ph III Modeling - November 6, 2014 (Seeking Alpha - Steven Giardino [Pyrr])
Now is the Time for Northwest Biotherapeutics - October 29, 2014 (Seeking Alpha - Steven Giardino (Pyrr)
U.K. May Grant Early Patient Access for DCVax-L Priot to Formal Approval  - September 18, 2014 (Seeking Alpha - Larry Smith [Smith on Stocks])
Exciting News on Potential for Early Patient Access for DCVax-L in the UK - September 17, 2014 
(Larry Smith, Smith on Stocks)
The Data Monitoring Commitee Addresses the Status of the DCVax-L Trial - August 13, 2014 (Seeking Alpha - Larry Smith [Smith on Stocks])
Cancer Vaccines:  Northwest Biotherapeutics -vs- Dendreon - July 15, 2010 (M.E.Garza, BioMedReports)

NWBO Press Releases 
NWBO Yahoo Headlines

UK News Coverage
NW Bio Announces $40 Million Financing - Further Equity by Woodford Funds April 2, 2015
Woodford's new biotech could be the next Amgen November 26, 2014 (Gavin Lumsden, Citywire Money)
Neil Woodford invests £16m in brain cancer vaccine company November 19, 2014 (Ashley Armstrong, The Telegraph)

NWBO - Short Seller Rebuttals and Information
Washington Post - Pulitzer Prize Winning Steven Pearlstein addresses NWBO and Short Selling
Citizens for Responsibility and Ethics in Washington (CREW) Requests SEC Investigate Manipulation of Drug Company Stock Price to Benefit Short Sellers
My Dialogue with Adam Feuerstein on Northwest Biotherapeutics - September 25, 2014 (Larry Smith, Smith on Stocks)
Jim Cramer Explains How the Stock Market is Manipulated - sounds a bit like some of the techniques used here.

Patent Information
Espacenet Patent information for NWBO
Patentdocs - Patent applications for NWBO
NWBO Receives U.S. Patent on Broad Processes for Producing More Potent Dendritic Cells - March 18, 2013 
NWBO's Patent Portfolio is Further Expanded with Manufacturing Automation Patent - September 10, 2013
NWBO Receives Approval of US Patent for Cost Saving Automation of High-Concentration DCVax Manufacturing - December 4, 2009

Patient Info
Prospective patients may contact NW Bio at

Orphan Drug Report 2014  (EvaluatePharma, October 2014 - see page 14 ) 

Research Posters
ITOC2 Poster 2015 - DCVax-L / Prolonged Survival in Patients with Recurrent GBM Who Are Treated with Tumor Lysate-Pulsed Autologous Dendritic Cells
SITC 2014 - Direct
ASCO 2014 - Direct

SEC Reports
Form 10-K - For fiscal year ended December 31, 2014

Stock Quote & Summary
As of November 17, 2014

Common Shares Outstanding:   76,861,294
Warrants Outstanding:               35,509,555
Convertible Debt:                         2,479,000
Options Outstanding:                   1,551,000
RSU's Outstanding:                                   0*
Total Fully Diluted Shares:       116,400,849

(*Note: RSUs authorized and issued Nov 12, 2014: 10,577,176 (5 years vesting based on service and performance conditions). None are vested yet. Anticipate adding 528,859/qtr beginning next quarter to reflect a straight line amortization estimate)

Beneficial Ownership of NWBO Common Stock held by: 
All executive officers and directors:                            40,382,602 
5% Security Holder – Toucan Partners, LLC:              4,105,474 
5% Security Holder – Cognate BioServices:             29,899,143 
5% Security Holder – Dennis Mehiel:                          4,105,843 
Total (@9/30/2014):                                                   78,493,062 

Shares of common stock beneficially owned assumes the exercise of all options, warrants and other securities convertible into common stock beneficially owned by such person or entity currently exercisable or exercisable within 60 days of September 30, 2014.

52-Week High - (as of November 14) $10.64
52-Week Low - (as of  November 14)  $3.20

Transfer Agent:  BNYMellon Shareowner Services
520 Pike Street, Seattle, WA, 98101
Equity Holding customer service representatives are available from 9:00 a.m. to 7:00 p.m. Eastern Time,
Monday through Friday. Call +1 800 522 6645 (U.S. & Canada).

UCLA Department of Neurology
UCLA Chair of Neurosurgery Neil A. Martin, M.D., FAANS - Welcome Letter
DCVax in 4th paragraph - "on the road to FDA approval"

A Personal Quest to Cure Brain Cancer - (Into The Brain and Beyond by UCLA Neurosurgery)

Upcoming Events
SPOTLIGHT PRESENTATION!! - Clinical Development of Dendritic Cell-Based Therapies for Both Resectable [L] and Unresectable Tumors [Direct]" - Monday, April 20, 3:00 to 4:00 (ONE HOUR)
by Marnix L. Bosch, MBA, PhD, CTO, NWBO
"DCVax®: Novel Pesonalized Immune Therapies for Solid Tumors" - World Vaccine Congress 2015, Washington D.C. - April 9, 2015, 10:25 a.m. ET - Linda Powers, CEO, NWBO
"Clinical and immunopathological effects following Image-guided intratumoral injection of activated, autologous dendritic cells in patients with advanced solid cancers" - Abstract #2499 - AACR (American Association for Cancer Research) - Abstract Presentation - Monday April 20, 2015, 1:00 to 5:00 p.m. 
"Treatment with tumor lysate-pulsed autologous dendritic cells prolongs survival in patient swith recurrent glioblastoma mulitforme" - Abstract #2491-AACR - Abstract Presentation - Monday April 20, 2015, 1:00 to 5:00 p.m. 

NWBO Presentation at ITOC2 Conference - March 26, 2015 - Webcast by Marnix L. Bosch, MBA, PhD, CTO, NWBO (sign up required)
NWBO Presentation at BIO CEO & Investor Conference - February 9, 2015 - Webcast by Linda Powers
NWBO Presentation at Phacilitate Immunotherapy World 2015 - January 26, 2015 - Webcast by Linda Powers (YouTube)
NWBO - Biotech Showcase 2015 Presentation - January 12, 2015 - Webcast by Linda Powers (sign up required)
Transcript of Biotech Showcase 2015 - provided by sentiment_stocks
NWBO - 2th Annual Oppenheimer Healthcare Conference - December 10, 2014 - Webcast by Linda Powers  (sign up required)
NWBO- 25th Annual Oppenheimer Healthcare Conference - December 10, 2014 - accompanying Slide Show
Transcript of 25th Annual Oppenheimer Healthcare Conference - provided by RK (Includes Q&A at the end)
Timeline of 25th Annual Oppenheimer Healthcare Conference - provided by Evaluate)

NWBO Linda Powers Presents at SMi 3rd Cancer Vaccines Conference 2014

A MUST SEE (sign up required):
Linda Powers Announces England's 1st PIM (Promising Innovative Medicine) Designation and Recent Progress to Date 
and gives a Good Explanation of how DCVax Works.

NWBO Company Website
Wiki page for NWBO
Informative Investor Website
Immunology Acronyms

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Current Price
Bid Ask Day's Range
Option Chain for NWBO
NWBO News: NW Bio Featured In Presentations At the American Association for Cancer Research Annual Meeting 04/20/2015 06:00:00 AM
NWBO News: NW Bio Included In New Index Of The "Top 25 Cancer Immunotherapy Companies" 04/16/2015 06:00:00 AM
NWBO News: Current Report Filing (8-k) 04/14/2015 01:50:12 PM
NWBO News: Current Report Filing (8-k) 04/08/2015 05:13:56 PM
#32338  Sticky Note Nearing “the finish line” on cancer vaccine trial, TheRedBaron888 04/03/15 03:58:34 PM
#30941  Sticky Note Regarding RECIST and the P1 Direct Trial… sentiment_stocks 03/17/15 03:40:36 PM
#30450  Sticky Note Forbes Article: Northwest Biotherapeutices Is a Best Idea sentiment_stocks 03/10/15 01:06:44 PM
#22663  Sticky Note SA Article: DCVax-Direct Validation and Updated DCVax-L Ph Pyrrhonian 11/06/14 04:17:55 PM
#33620   Also very exciting in September we released information Rkmatters 04/21/15 07:18:13 AM
#33619   What about all of your lies Pyrr? By DoGood_DoWell 04/21/15 07:05:03 AM
#33618   Momentum Stocks: Bristol-Myers Squibb Company (NYSE:BMY), Northwest Biotherap john1045 04/21/15 06:14:49 AM
#33617   This is from investment blog, the Astute Investor longfellow95 04/21/15 06:01:27 AM
#33616   No John - Fierce did not give us RRRichmond 04/21/15 05:32:18 AM
#33615   guess he is a short or a paid terragord7 04/21/15 05:27:11 AM
#33614   I agree it's the way you just Jack2479 04/21/15 03:25:48 AM
#33613   Linda never lied? Didn't she say the trial sentiment_stocks 04/21/15 02:39:41 AM
#33612   Wow, 61% ORR! staccani 04/21/15 02:00:55 AM
#33611   Pissed? No, not even a little. Pyrrhonian 04/21/15 12:14:37 AM
#33610   Hey long. Thanks and ditto. Pyrrhonian 04/21/15 12:04:48 AM
#33609   Just trying to understand your recent barrage. Kind Ready4bluesky 04/20/15 11:35:52 PM
#33608   Lol. No it's not. I cornered you and Rkmatters 04/20/15 11:33:24 PM
#33607   The last word :) Pyrrhonian 04/20/15 11:32:09 PM
#33606   Can you say for sure that those 25 Rkmatters 04/20/15 11:30:20 PM
#33605   Dude I'm not going to get into a Pyrrhonian 04/20/15 11:28:25 PM
#33604   LOL. Here is what you said Pyrr. flipper44 04/20/15 11:26:04 PM
#33603   How much money have you lost on nwbo Ready4bluesky 04/20/15 11:22:35 PM
#33602   No, you really perfectly proved my point. Ace Pyrrhonian 04/20/15 11:21:46 PM
#33601   Those were not ePD flipper! Pyrrhonian 04/20/15 11:17:03 PM
#33600   I did no such thing. Saying I did Rkmatters 04/20/15 11:15:21 PM
#33599   I thought you might say that. :-) flipper44 04/20/15 11:01:45 PM
#33598   You just perfectly proved my point! Pyrrhonian 04/20/15 11:01:11 PM
#33597   Also very exciting in September we released information Rkmatters 04/20/15 10:58:00 PM
#33596   At least quote me in context. I was Pyrrhonian 04/20/15 10:55:06 PM
#33595   Don't like 'religion'! "Rejoice" - to celebrate... A "God" - JSwy17 04/20/15 10:54:45 PM
#33594   A minor detail. What about biopsy only patients? Pyrrhonian 04/20/15 10:52:28 PM
#33593   It's simple. If Linda wanted to portray those Pyrrhonian 04/20/15 10:49:46 PM
#33592   Wrong again. flipper44 04/20/15 10:47:31 PM
#33591   See the prior post on KPS Rkmatters 04/20/15 10:40:41 PM
#33589   Seriously Pyrr, you're debating semantics. At every investor Rkmatters 04/20/15 10:37:49 PM
#33588   $5s will never be back. You sure? Pyrrhonian 04/20/15 10:34:09 PM
#33587   Haha, o-KAY! One more round.. Pyrrhonian 04/20/15 10:29:14 PM
#33586   The data is from a "Do Good Do DoGood_DoWell 04/20/15 10:14:53 PM
#33585   Not happening. Too many foundations have been made DoGood_DoWell 04/20/15 10:08:45 PM
#33584   Yes - quite. and long. DoGood_DoWell 04/20/15 10:05:53 PM
#33583   Linda never lied? Didn't she say the trial Pyrrhonian 04/20/15 09:50:34 PM
#33582   Quote: -Confounded? Not after 6 months. If after 6 flipper44 04/20/15 09:47:36 PM
#33581   The diagnosis of PsP was made if no Pyrrhonian 04/20/15 09:14:16 PM
#33579   -Confounded? Not after 6 months. If after 6 Pyrrhonian 04/20/15 08:57:06 PM
#33578   I guess we have to wait till tomorrow terragord7 04/20/15 08:37:18 PM
#33575   I think it's fun too. You do make Rkmatters 04/20/15 07:51:14 PM
#33574   Wow, that caused a stir huh?! I knew Pyrrhonian 04/20/15 07:35:42 PM
#33573   EVERYONE has an agenda. -DJ Pyrrhonian 04/20/15 07:29:55 PM
#33572   Thank you Sentiment for the reality check. Diamondjim61 04/20/15 07:14:31 PM
#33571   Senti....great post and appreciate you taking the time john1045 04/20/15 06:53:00 PM
#33570   SENTI. PINKY SLAP!!! :) Rkmatters 04/20/15 06:37:28 PM
#33569   I second that...Boo-yah! Steppenwolf_Speaks 04/20/15 06:17:54 PM
#33568   Big thanks to Flipper, Senti, and others for longfellow95 04/20/15 05:54:47 PM
#33566   See that sent? 348 main cohort. Also first sentiment_stocks 04/20/15 05:37:47 PM