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NorthWest Biotherapeutics (NWBO)

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Last Post: 3/6/2015 8:11:08 PM - Followers: 225 - Board type: Free - Posts Today: 59







 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

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  lgoldman@nwbio.com
Farrell Kramer (Media)  (212) 710-9685  farrell.kramer@mbsvalue.com or media@nwbio.com

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)

Interviews
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

NWBO Analysis
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 News
NWBO Press Releases 
NWBO Yahoo Headlines

UK News Coverage
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
Patent information 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 patients@nwbio.com

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

Research Posters
SITC 2014 - Direct
ASCO 2014 - Direct

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
"Central Role of DC in Immune Therapy" - Forum Life Science 2015 - Germany - March 11-12, 9:15 to 9:40 - Dr. Marvin Bosch, CTO, Northwest Biotherapeutics GmbH, Leipzig
"Proffered Paper:  Prolonged Survival for Patients with Recurrent Glioblastoma Multiforme who are Treated with Tumor Lysate-Pulsed Autologous Dendritic Cells" - ITOC-Conference, Munich, Germany - March 26, 2015, 14:40 - Marnix Bosch, Chief Technical Officer, NW Bio

Webcasts
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.


Websites
NWBO Company Website
Wiki page for NWBO
Informative Investor Website
 

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NWBO
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Volume:
Bid Ask Day's Range
Wiki
Option Chain for NWBO
NWBO News: Current Report Filing (8-k) 02/23/2015 04:53:17 PM
NWBO News: NW BIO'S PHASE III TRIAL OF DCVAX®-L FOR GBM BRAIN CANCER APPROVED TO PROCEED IN CANADA AND UNDER WAY AT TWO SITES 02/19/2015 12:55:00 PM
NWBO News: Amended Statement of Ownership (sc 13g/a) 02/11/2015 05:01:44 PM
NWBO News: Current Report Filing (8-k) 02/10/2015 02:58:19 PM
NWBO News: NW Bio To Present At 17th Annual BIO CEO & Investor Conference 02/06/2015 09:15:00 AM
PostSubject
#29369  Sticky Note Right, Jim. Folks looking for a sure Astavakra 02/11/15 11:06:55 AM
#28276  Sticky Note BioTech Showcase 2015, January 12, 2015 Transcript sentiment_stocks 01/13/15 08:19:27 PM
#22663  Sticky Note SA Article: DCVax-Direct Validation and Updated DCVax-L Ph Pyrrhonian 11/06/14 04:17:55 PM
#21296  Sticky Note DCVAX®-L HOSPITAL EXEMPTION PROGRAM NOW UNDER WAY IN GERMANY TOB 10/14/14 03:37:40 PM
#30307   AF just tweeted that liking NWBO is fine. Rkmatters 03/06/15 08:11:08 PM
#30306   Has anyone seen this? Diamondjim61 03/06/15 08:05:18 PM
#30305   Preliminary tests show Oxygenation improves outcome of mice RRRichmond 03/06/15 08:03:51 PM
#30304   thanks Mav I will check it out even mapman1010 03/06/15 06:48:53 PM
#30303   It really is. I can't help it. :) Rkmatters 03/06/15 06:40:18 PM
#30302   RK I am finally coming around to your mapman1010 03/06/15 06:32:58 PM
#30301   Wooo hooo is correct. These things take Rkmatters 03/06/15 05:59:00 PM
#30300   I ain't unhappy :) H2R 03/06/15 05:57:10 PM
#30299   Well if you're long, I'd think you'd be sentiment_stocks 03/06/15 05:30:59 PM
#30298   Nice. Sub Atomic master 03/06/15 05:16:07 PM
#30297   Just catching up. iclight 03/06/15 05:15:46 PM
#30296   I know, another down day...oh me, oh my highwayman4life 03/06/15 05:04:14 PM
#30295   Almost 9,000 views so far today according to Smokey21 03/06/15 04:20:06 PM
#30294   That will be cool. :) Rkmatters 03/06/15 03:59:41 PM
#30291   OT read for immunotherapy junkies...while we wait Homework.Investwell 03/06/15 02:53:14 PM
#30290   Today's article was perfectly timed, to neutralize the Smokey21 03/06/15 02:44:59 PM
#30289   I gave the author a kick to on Sub Atomic master 03/06/15 02:44:19 PM
#30288   Hey Iclight... sentiment_stocks 03/06/15 02:40:32 PM
#30287   In my years RK ive seen no Sub Atomic master 03/06/15 02:11:11 PM
#30286   As soon as my cpa is thru with Sub Atomic master 03/06/15 01:30:43 PM
#30285   Branko Krstevski Forbes NWBO article by KEVIN LAM maverick_1 03/06/15 01:26:16 PM
#30283   NWBO tracking index funds. mapman1010 03/06/15 12:33:05 PM
#30282   ;) Rkmatters 03/06/15 12:22:57 PM
#30281   LP and Regina WILL GET THE JOB DONE! maverick_1 03/06/15 12:04:56 PM
#30280   Btw, I'm reaching out to high net worth Rkmatters 03/06/15 11:51:03 AM
#30279   I think the general market correction today is Smokey21 03/06/15 11:45:30 AM
#30278   Thanks Maverick. Spot on. :) Rkmatters 03/06/15 11:44:07 AM
#30277   Obviously sell triggers. Poor folks will miss the Rkmatters 03/06/15 11:43:43 AM
#30276   Branko's Forbes article followup: maverick_1 03/06/15 11:38:24 AM
#30275   I think we will take the high out Doc x 4 03/06/15 11:34:11 AM
#30274   Someone used the nice little up spike from Ready4bluesky 03/06/15 11:26:36 AM
#30273   Damn, what a down spike Doc x 4 03/06/15 11:25:01 AM
#30272   Thanks for posting this article Senti! Much appreciated! ATLnsider 03/06/15 11:16:52 AM
#30271   Thanks for the article Senti! Etienne1 03/06/15 10:44:47 AM
#30270   March 6, 2015 NASDAQ:NWBO Papa Tweek1 03/06/15 10:43:18 AM
#30269   You hit it right on the cranial cavity Sub Atomic master 03/06/15 10:34:33 AM
#30268   If certain board members do not have the foxhound02 03/06/15 10:32:47 AM
#30266   Pretty good creds for Branko: His Marketocracy portfolio Astavakra 03/06/15 10:22:35 AM
#30265   Ok, thanks... CaptainOblivious 03/06/15 10:22:17 AM
#30264   The way Linda put it, it was their Astavakra 03/06/15 10:18:35 AM
#30263   Really? I'm sure the Forbes contributor Ken sentiment_stocks 03/06/15 10:17:37 AM
#30262   I don't understand the need for testing alongside CaptainOblivious 03/06/15 10:16:26 AM
#30261   Comment from Forbes article: Astavakra 03/06/15 10:10:10 AM
#30259   You know, you really should not copy and foxhound02 03/06/15 09:58:58 AM
#30258   Keep in mind that there will be a Rkmatters 03/06/15 09:58:01 AM
#30257   That's because he's an intelligent human being, not Astavakra 03/06/15 09:46:14 AM
#30256   Thanks Senti. What a lovely start of the Astavakra 03/06/15 09:37:00 AM
#30255   Finally. Others will follow. Bye bye 7s Rkmatters 03/06/15 09:36:46 AM
#30254   nice pity when asked about AF HE DIDNT SAY sitiain 03/06/15 09:26:11 AM
#30253   Northwest Biotherapeutics Is A Best Idea john1045 03/06/15 09:13:29 AM
PostSubject