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Expert Financial Analysis and Reporting

Northwest Biotherapeutics: Why I Believe That the Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma Patients Has a Very Good Chance for Success (NWBO, Buy, $0.17)

Overview

This report is an extensive update on almost everything I know about the DCVax-L phase 3 trial and is over…
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Northwest Biotherapeutics: Is There Any Chance for DCVax-L to be Successful in the Phase 3 Trial? (NWBO, Buy, $0.24)

Acronyms Used in this Report

SOC: The standard of care in newly diagnosed glioblastoma patients is surgical resection followed by…
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Northwest Biotherapeutics and Agenus: What Are The Implications for These Companies in the Aftermath of Two Recent Cancer Vaccine Trial Failures? (NWBO, $0.38, Buy) (AGEN, $3.99, Buy)

Two Recent Cancer Vaccine Trial Failures Spurred this Report

On February 22, 2017, Argos reported that the Data Monitoring Committee for…
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Northwest Biotherapeutics: 8-K Document Released Today Provides New and Very Interesting Data on Patients Treated with DCVax-L. (NWBO, Buy, $0.48)

Substance of 8-K Regulatory Document

Northwest issued an 8-K today in response to shareholders’ questions about an issue that has been…
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Northwest Biotherapeutics: Partial Clinical Hold on Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma is Lifted (NWBO, Buy, $0.45)

Key Points:

Lifting of the partial hold removes a cloud that has been overhanging the Company for the past 18…
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Northwest Biotherapeutics: DCVax-L Viewed Through the Eyes of Dr. Linda Liau, Lead Investigator on the Phase 3 Trial of DCVax-L (NWBO, $0.35, Buy)

Principal Takeaway Messages  from This Report

Dr. Linda Liau believes that use of DCVax-L can result in 25% of glioblastoma patients…
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Northwest Biotherapeutics: Phase 2 Trial in Colorectal Cancer with Liver Metastases Announced (NWBO, Buy, $0.55)

NWBO is preparing for the start of a phase 2 trial combining DCVax-L with Merck’s Keytruda in late stage colorectal cancer with…
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Northwest Biotherapeutics: Recent Data Update on Phase 1/2 Trial of DCVax Direct is Encouraging (NWBO, Speculative Buy, $0.43)

Key Points:

Data for DCVax Direct recently was updated for its phase 1/2 trial in 40 patients having 13 different…
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Northwest Biotherapeutics: Going Over My Thoughts (NWBO, $0.62)

Overview

The naming of five distinguished scientists with extensive knowledge and expertise in immune-oncology to Northwest’s scientific advisory board is the…
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Northwest Biotherapeutics: The Company Provides an Operations Update (NWBO, $1.23)

Report Overview

I usually start my reports with a summary and investment thesis. However, in this report I am putting this…
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Northwest Biotherapeutics: A Comprehensive Evaluation of Its Lead Product DCVax-L (NWBO, $1.50)

Perspective and Overview on this Report

The still unexplained and unresolved halt in screening for the phase 3 trial of DCVax-L…
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Northwest Biotherapeutics: Why the Failure of Celldex’s Rintega in Newly Diagnosed Glioblastoma Probably Has No Implications for the DCVax-L Trial

Investment Thesis

Some subscribers have asked me if the failure of Rintega in the phase 3 ACT-IV trial in newly diagnosed…
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Northwest Biotherapeutics (NWBO): Some Thoughts about the Appointment of Two New Board Members

Purpose of the Report

Northwest Biotherapeutics announced on January 25 that it is adding two new members to its current…
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Northwest Biotherapeutics: Seeking Alpha Publishes Latest in a String of Attack Articles Authored by Short Sellers (NWBO, $4.92)

Seeking Alpha has published an extremely negative article by anonymous short sellers that alleges criminal misconduct on the part of management…
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Northwest Biotherapeutics: New Financing from Woodford was Much Needed (NWBO, $5.44)

Curses, Foiled Again; The Hedge Fund’s Lament

The clear intent of the recent short attack on Northwest was at a minimum…
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Northwest: Analysis of a Coordinated Short Selling Attack Against the Stock (NWBO, $4.69)

A Suspect Plunge in Price

On Friday October 16, 2015 a day in which the Dow Jones and S&P averages increased…
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Northwest Biotherapeutics: My Thoughts on the New Data from the Phase 1/2 Trial of DCVax Direct (NWBO, Buy, $6.91)

Critical Issue in Interpreting the Data
Northwest just recently presented length of survival data for 39 patients evaluated in its phase…
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Northwest Biotherapeutics: Thoughts on Suspension of Screening of New Patients in the Phase 3 DCVax-L Trial

Reason for Report

On August 21, Northwest put out a press release that said that screening of new patients has been…
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Implication of the Juno Celgene Deal for Emerging Immuno-Oncology Biotechnology Stocks in General and Northwest Biotherapeutics in Particular

The Terms of the Juno Celgene Deal

Celgene and Juno announced a ten year collaboration for drug development using CAR-T therapy…
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Observations from ASCO on Immuno-oncology with a Focus on Northwest Biotherapeutics’ (NWBO, Buy, $9.43) DC-Vax-Direct© and the Checkpoint Inhibitors of Bristol-Myers Squibb and Merck

Key Investment Points Stemming from ASCO

I have been going over data presented at ASCO on immune-oncology products and have been…
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Comments on Antares, Kite Pharma and Northwest Biotherapeutics

SmithOnStocks Mailbox
About the Mailbox:

My mailbox comments are brief articles on stocks in which I am involved. These can come from…
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CAR-T Companies-Kite (KITE, $55.09) and Juno (JUNO, $47.30): Is The Bloom Coming Off The Rose? Are Investor Expectations Unrealistic?

Introduction to This Thought Piece

Emerging biotechnology stocks obviously are very hard to value on an absolute basis because they usually…
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Northwest Biotherapeutics: Comments on Two AACR Posters (NWBO, $8.62, Buy)

Introduction

I have included an abstract on DCVax Direct and another on DCVax-L that will be presented in poster presentations at…
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Northwest Biotherapeutics: The $40 Million Woodford Financing is A Major Positive (NWBO, Buy, $7.76)

The $40 million will fund the Company through the end of 2015.
CEO Linda Powers indicates that this is the cornerstone…
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Northwest Biotherapeutics: Highlights of the 2014 10-K (NWBO, Buy, $7.81)

Introduction

Northwest Biotherapeutics just issued their 10-K for 2014 and I would urge everyone to read it. The purpose of this…
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Northwest Biotherapeutics: How Much Will It Cost to Manufacture DCVax-L (NWBO, Buy, $7.26)

There has been a lot of speculation about how much it costs to manufacture one course of individualized therapy of…
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The Potentially Key Role of Northwest Biotherapeutics in the Emerging Immuno-Oncology Landscape (NWBO, Buy, $6.19)

Investment Overview

Linda Powers was invited to the 7th Annual Phacilitate Immunotherapy Forum in Washington D.C. to speak on the potential…
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Northwest Biotherapeutics: Some Thoughts about the Upcoming Presentation by CEO Linda Powers on Monday, January 26th. (NWBO, Buy, $6.28)

Ms. Powers will present at 10:30 AM.
She will then participate in a discussion panel with representatives from Amgen, Roche Diagnostics,…
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Immuno-Oncology Promises to be the Next “Big Thing” In Biotechnology

Immuno-Oncology Promises to be the Next “Big Thing” In Biotechnology
Purpose of the Report

Immuno-oncology has been the hottest area in biotechnology…
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Notes from Linda Powers Presentation in San Francisco, January 12, 2015 (NWBO, Buy, $6.00)

Overview

Linda Powers spoke at the Biotech Showcase Conference in San Francisco on January 12, 2015. My Buy recommendation on Northwest Biotherapeutics…
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Northwest Biotherapeutics: Capital Raise of $35 Million could be a Positive Catalyst for the Stock (Buy, $5.14)

Neil Woodford, a highly respected UK portfolio manager has just invested $25 million on very favorable terms and the Company…
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My Dialogue with Adam Feuerstein on Northwest Biotherapeutics

Perspective
I think that all investors in Northwest Biotherapeutics (NWBO) would concur that Adam Feuerstein has a vendetta against NWBO and…
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Northwest Biotherapeutics: Exciting News on Potential for Early Patient Access for DCVax-L in the UK

UK designates DCVax-L as first drug to be considered for early access approval under recently enacted EAMS program.
Earlier this year,…
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Northwest Biotherapeutics: National Geographic Special Features DCVax Direct Treatment of Stage 4 Pancreatic Cancer Patient (NWBO, Buy, $5.90)

DCVax Direct was used in a patient with stage 4 pancreatic cancer whose chemotherapy was stopped.
The patient, a Nat Geo…
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Northwest Biotherapeutics: Independent Chairman of the DMC Committee for DCVax-L Phase 3 Trial Chastises Adam Feuerstein for Inaccurate Articles (NWBO, Buy, $6.43)

 

The Data Monitoring Committee (DMC) is charged with monitoring the safety and efficacy results of clinical trial. The committee and…
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CREW Alleges That Adam Feuerstein is Involved in Stock Manipulation Scheme in Regard to Northwest Biotherapeutics

Citizens for Responsibility and Ethics in Washington (CREW) have gone after Adam Feuerstein of The Street.com. They have accused him…
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Northwest Biotherapeutics: Market Research Firm Evaluate Pharma Projects 2020 Worldwide Sales of $2.0 billion for DCVax-L (NWBO, Buy, $5.92)

One of the basic charges made against me by Richard Pearson and other short sellers is that they maintain that…
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Northwest Biotherapeutics: Sixteenth Feuerstein Attack on the Company (NWBO, Buy, $8.11)

Adam Feuerstein has just  launched its 16th negative blog on Northwest Biotherapeutics since the beginning of March and this has…
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Northwest Biotherapeutics: The Perfect Storm May Be Brewing for Short Sellers (NWBO, $7.66, Buy, Free Content)

I wrote on June 12th  that NWBO stockholders may be seeing a changing in the tide of investor opinion. The…
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Northwest Biotherapeutics: The Investment Tide May be Turning Positive (NWBO, Buy, $6.41, free content)

Purpose of Report

This report goes over recent news on the company in regard to DCVax Direct and DCVax-L and then…
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Northwest Biotherapeutics: Management Discusses Interim Data on Phase 1/2 Trial of DCVax-Direct (NWBO, Buy, $6.00, free content)

Introduction

Northwest Biotherapeutics held a conference call on May 27th to discuss interim results of its phase 1/2, first in human,…
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Northwest Biotherapeutics to Host Conference Call This Afternoon, May 27th (NWBO, Buy, $6.25)

Northwest Biotherapeutics announced today that the Company will host a conference call and webcast  with CEO Linda Powers today, May…
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Northwest Biotherapeutics Releases Promising Early Results in DCVax Direct Phase 1 Trial (NWBO, $6.20, content of this note is not limited to subscribers)

Overview

Northwest Biotherapeutics told investors that it would discuss initial results of the phase 1/2 trial of DCVax-Direct in inoperable solid…
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Northwest Biotherapeutics: Update On DCVax-Direct Based on ASCO Abstract and Positive, Early Results for First Patient Reported On (NWBO, Buy, and $5.94)

Investment Conclusion

The ASCO abstract on DCVax-Direct was released last night. It contains only a description of the drug and the…
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Thoughts on the Market Correction in Biotechnology Stocks

This Has Been a Tough Correction

The recent sharp market correction and rotation out of growth stocks like biotechnology and technology…
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Northwest Biotherapeutics: Just Announced Financing Signals High Expectations for Use of DCVax-L under German Hospital Exemption Program (NWBO, $6.75, Paid Subscribers)

Purpose of New Financing

Northwest Biotherapeutics just announced a financing in which a single institutional investor bought $15 million of stock…
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Refuting Feuerstein’s Latest Negative Blog on Northwest Biotherapeutics (NWBO, Buy, $7.56)

Before I Get Into This Article, a Word to My Subscribers

I want to apologize to my subscribers for a software…
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Northwest Biotherapeutics (NWBO, Buy, $7.59) What the 2014 10-K Had to Say about the Approval of DCVax-L under the German Early Access Program

Purpose of This Blog

The approval of DCVax-L under the hospital exemption early access program was a stunning positive in my…
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Northwest Biotherapeutics (NWBO, Buy, $7.90): DCVax-L Is Approved in Germany under Hospital Exemption Early Access Program

Introduction

Please read this report very carefully. This is the first time that any systemic drug has been approved under the…
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Northwest Biotherapeutics (NWBO, $6.06, Buy): Comments on First Interim Look at DCVax-L Trial and Recent Weakness in the Stock

Reason for Stock Weakness

The stock of Northwest Biotherapeutics (NWBO) has been under pressure that appears largely to have been caused…
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SmithOnStocks Mailbox February 25, 2014

I have found that there are some very smart people out there who have interesting questions and perspectives concerning my…
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The BIO CEO Conference: Highlights from the Meeting and New Investment Perspectives (Subscribers Only)

Back From BIO CEO Conference

I have returned from spending two days at the BIO CEO conference at the Waldorf Astoria…
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SmithOnStocks Mailbox January 28, 2014

In my writing, I have found that there are some very smart people out there who have interesting questions and…
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San Francisco Trip Is the Basis for a Preview of 2014 (Subscribers Only)

What SmithOnStocks Is All About
It is traditional at the start of the year to go over stock picks for the…
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Adam Feuerstein’s Views on Northwest Biotherapeutics (NWBO, $3.37)

Adam Feuerstein has consistently disagreed with authors who believe that there is a sound basis for Northwest Biotherapeutics (NWBO) conducting…
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Northwest Biotherapeutics: An Analysis of Its Transforming Balance Sheet Restructuring (NWBO, $4.14)

Key Takeaway Points of this Report
Northwest (NWBO) restructured much of its debt in 4Q, 2012 and also has raised significant…
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Northwest Biotherapeutics ($3.44): M.D. Anderson’s Lead Role in DCVax Direct Trial is Encouraging

Northwest Biotherapeutics (NWBO) announced today that the phase I/II trial of DCVax Direct has been initiated at M.D. Anderson Cancer…
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SmithOnStocks Opines on Biotechnology Stocks, June 2, 2013

Overview of This Week's Report
This week I published a major report on Alimera Sciences and pSivida which led to my…
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SmithOnStocks Opines on Biotechnology Stocks, May 28, 2013

Introduction
I have started to write a newsletter on a weekly or bi-weekly basis to supplement my reports and blogs. In…
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Highlighting A New Report on Dendritic Cell Cancer Vaccines

Northwest Biotherapeutics’ (NWBO) DCVax-L and ImmunoCellular Therapeutics’ ICT-107 are dendritic cell cancer vaccines that are in phase II trials for…
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