SecProbe.io

CORRESP
1
filename1.htm

    Unassociated Document

                Northwest

                  Biotherapeutics,
      Inc.

                t
      (240)
      497-9024

                www.nwbio.com

                OTCBB:  NWBT

                4800 Montgomery Lane

                Suite 800

                Bethesda, MD 20814

                f
      (240)-627-4121

                  aboynton@nwbio.com

                Alton
      L. Boynton, Ph.D.

                President
      and Chief Executive Officer

    January
13, 2011

    VIA
EDGAR ONLY

    United
States Securities and Exchange Commission

    100 F
Street, NE

    Washington,
D.C. 20549

              Attention:

              Jim
      B. Rosenberg,

              Senior
      Assistant Chief Accountant

              Re:

              Northwest
      Biotherapeutics, Inc.

              Form
      10-K for the year ended December 31, 2009

              Form
      10-Q for the quarter ended September 30, 2010

              File
      No. 000-33393

    Dear Mr.
Rosenberg:

      This
letter is in response to the comments of the staff of the U.S. Securities and
Exchange Commission (the “Commission”) with respect to the above-referenced
filings provided in your letter dated December 16, 2010 (the “Comment
Letter”).  In response to these comments, Northwest Biotherapeutics,
Inc. (the “Company”) shall file Amendment No. 1 on Form 10-K for the year ended
December 31, 2009 and Amendment No. 1 on Form 10-Q for the quarters ending March
31, 2010, June 30, 2010 and September 30, 2010.  The purpose of this
correspondence is to illustrate these changes to the Commission and provide
explanation, where necessary.  Our responses follow the text of each
Staff comment reproduced consecutively for your convenience.

    Form 10-K for the fiscal
year ended December 31, 2009

    Item
1.  Business

    Intellectual Property, page
13

              1.

              We
      note your statement that you have “33 issued and licensed
      patents.”  To the extent that your technology is substantially
      dependent on patents licensed from third parties, please identify the
      parties, and provide proposed disclosure describing the terms of the
      licenses and file copies of the agreements as exhibits.  If you
      believe you are not substantially dependent on these licenses, please
      provide us with an analysis us supporting your
    determination.

    We have a
robust program of clinical trials using our lead technology (immune therapy),
with late stage clinical trials for two cancers (one under way and the other
approved by FDA but not yet under way) and early stage trials for five other
cancers approved by FDA. These products and trials involve the intellectual
property that is owned by the Company and not licensed.  None of these
products or trials require the intellectual property that is licensed, and these
products and trials are the only ones that the Company is currently actively
developing.  Accordingly, Management does not believe the Company is
substantially dependent upon the licenses, nor that further disclosure about the
licenses is needed.

      We
protect our proprietary technologies through patents issued and licensed
throughout the world. We have 33 issued (9 in the U.S. and 24 in other
jurisdictions) and 134 patent applications pending (15 in the U.S. and 119
in other jurisdictions) which cover the use of DCs in DCVax ® as well
as targets for either the Company’s DC or monoclonal antibody therapy candidates
and isolation and manufacturing, handling and administration of DCVax ®. The
issued patents expire at various dates between 2015 and 2026.  Among
all these patents, only 3 issued U.S. patents and 6 pending U.S. and foreign
patents have been licensed.  The licenses were obtained from Northwest
Hospital as part of our founding agreement. The remaining 24 issued patents and
134 pending patent applications are owned by the Company. The technology covered
by the patents licensed from Northwest Hospital is not relevant to our core
immunotherapy technologies which are in clinical trials as explained
above.

    Item
7.  Management’s Discussion and Analysis of Financial Condition and
Results of Operations

    Results of
Operations

    Year Ended December 31, 2008
Compared to the Year Ended December 31, 2009, page 34

              2.

              Please
      provide proposed disclosure to be included in future filings to include an
      explanation for the loan conversion inducement recorded during
      2009.

    The
following language will be included in future filings:

    In
September 2009, Toucan Partners agreed to convert $1,156,718, representing
principal and accrued interest (including a default penalty of 0.25% per month)
outstanding on the $1.0 million loan made to the Company on August 19, 2008, and
$552,738, representing principal and accrued interest (including a default
penalty of 0.25% per month) outstanding on a loan made to the Company on
December 22, 2008.  This total of $1,709,456 was converted into
8,547,280 shares of the Company’s common stock.  Additionally in
connection with the conversions the Company issued Toucan Partners warrants to
purchase 842,375 shares at an exercise price of $0.20 per share and warrants to
purchase 513,841 shares at an exercise price of $0.41 per share. The terms
relating to the Toucan Partners conversions were based upon and conformed to the
terms upon which non-affiliated sophisticated investors made investments in the
Company in the same periods.  The value of the stock issued to Toucan
Partners in excess of the carrying amount of the loans and accrued interest
payable amounted to $4,701,004, and together with the fair value of the
warrants, of $916,716, was charged to loan conversion inducement expense in the
accompanying consolidated statements of operations during the quarter ended
September 30, 2009.

    Liquidity and Capital
Resources, page 34

              3.

              In
      future filings please provide a discussion of your short term capital
      requirements and sources available.

    We will
provide a discussion of the Company’s short term capital requirements and
available sources of capital in future filings.

    Contractual Obligations,
page 36

              4.

                To
      the extent that your agreements with Synteract, Media Marketing Connect
      LLC  and Dr. David Filer are material, please describe the
      material terms of each.  The description should include the
      nature of each party’s obligations, required payments, term and
      termination provisions, as well as any other material terms.  If
      you are substantially dependent on any of the agreements, please file them
      as exhibits.

      The
contracts with Synteract, Media Marketing Connect and Dr. David Filer are
service contracts entered into in the normal course of
business.  Synteract is a clinical research organization which has
been retained to monitor the Company’s clinical activities.  Media
Marketing Connect and Dr. David Filer have both been engaged to provide investor
relations and public relations advice and support.  The agreements are
commercially competitive.

              Party

              Payments

              Term

              Termination

              Dr.
      David Filer

              $5,000
      per month plus warrant to purchase 100,000 shares at $0.75
      each

              2
      Years commencing January 1, 2010

              Other
      than “For Cause or breach” may be terminated on 60 days
    notice

              Market
      Media Connect LLC

              $10,000
      per month plus warrant to purchase 250,000 shares at
      higher  of  $1.00 or 75% of highest price at which
      funds are raised during the term of agreement

              February
      1, 2010 to August 1,  2010

              30
      days notice

              Synteract

              Quoted
      fees and reimbursement of out-of-pocket costs

              Duration
      of Phase II/III clinical trials

              30
      Days

    The
Company is not substantially dependent on any of these contractors as there are
numerous other contractors that provide similar services and management does not
believe the contracts have a material impact on the financial position,
operations or cash flows of the Company.

    Directors, Executive
Officers and Corporate Governance, page 37

              5.

              Please
      provide draft disclosure that discusses the specific experience,
      qualifications, attributes or skills of each director that led to the
      conclusion that the person should serve as a director for the registrant
      as required by Item 401(e) of Regulation
S-K.

    The
Company proposes the following disclosure regarding the specific experience,
qualifications, attributes or skills of each director and executive officer
which led to the conclusion that he/she should serve.

    Alton L. Boynton,
PhD:  As a result of Dr. Boynton’s significant years of service
as a director and running a number of programs focusing on oncology and
cancer-related research programs, including a PhD in Radiation Biology, the
Company concluded that Dr. Boynton should serve as a director and executive
officer.

      Linda F.
Powers:  Ms. Powers has over 25 years of experience in
corporate financings and business transactions, including 10 years specializing
in biotechnology investment and company building.  Ms. Powers has
served for a number of years on Boards of a leading immunology research
institute, a large cancer center and more than half a dozen biotechnology
companies.  The Company believes this background and experience makes
Ms. Powers well qualified to serve as a Director.

    Robert Farmer:  The
Company concluded Mr. Farmer should serve as a director of the Company due to
his previous business successes, his experience as treasurer in four
presidential campaigns and his service on other boards of directors (including
International Data Group, Dale Carnegie Associates, Sober Steering Sensors and
Clark Ridge Publishing).

    Notes to the Consolidated
Financial Statements

    (5) Stockholders’ Equity
(Deficit)

    (c) Common Stock Issuances,
page 65

              6.

              Please
      explain to us why you valued the common stock issued for services in 2009
      based on the price of your common stock in recent financing transactions
      rather than on the quoted market price.  Please cite the
      authoritative accounting literature you relied upon in your
      analysis.

    The
authoritative guidance used to account for these transactions are set forth
below.  This guidance establishes that the value to be used is the
“fair value” of the stock.

              ·

              Accounting Standards
      Codification Paragraph 505-50-30-2:  Paragraph
      505-50-30-6 establishes that share-based payment transactions with
      nonemployees shall be measured at the fair value of the consideration
      received or the fair value of the equity instruments issued, whichever is
      more reliably measurable.

              ·

              Accounting Standards
      Codification Paragraph 505-50-30-11:  An entity (the
      issuer, grantor, or purchaser) may enter into transactions with
      nonemployees in which equity instruments are issued in exchange for the
      receipt of goods or services or to provide a sales incentive. The issuer shall
      measure the fair value of the equity instruments in these transactions
      using the stock price and other measurement assumptions as of the earlier
      of the following dates, referred to as
      the measurement date:

              o

              The date at which a
      commitment for performance by the counterparty to earn the equity
      instruments is reached (a performance commitment),
    or

              o

              The date at which the
      counterparty's performance is
complete.

    The stock
that was issued for services in 2009 was unregistered, restricted
stock.  As such, it carried a materially different “fair value” than
tradable stock that is quoted in the market.  (In addition, it is
worth noting that in the market at the time, our stock was very thinly traded –
with daily volumes in the tens of thousands of shares – and
volatile.)

    The
reference point we used for determining the “fair value” of the unregistered,
restricted stock was the price at which we were able to conclude actual
financing transactions with arms length, non-affiliated sophisticated
parties at the time for the same unregistered class of stock.  During
all of 2009, and especially during Q2 and Q3 of 2009, we tried very urgently for
months and months on end to obtain financing on any basis (debt, equity, etc.)
from any parties, either new or existing investors.  The Great
Recession market circumstances were very severe in the biotech sector at that
time.  After months of pursuing many, many potential investors, we had
to accept the price that investors were willing to pay.  We used this
same price, which arms-length investors were willing to pay for such
unregistered shares, as the benchmark for determining the “fair value” of
the  stock issued for services.

    Signature, page
77

              7.

              Pursuant
      to General Instruction D of Form 10-K, your Form 10-K must be signed by
      your principal executive officer, principal financial officer, controller
      or principal accounting officer, and a majority of the board of
      directors.  As it does not appear that it has been signed by a
      majority of the board of directors, you should amend your filing to
      include all required signatures.  To the extent that Mr. Boynton
      serves in the capacity as principal executive officer, principal financial
      officer, and controller or principal accounting officer, the signature
      block should so indicate.

      We will
revise the Form 10-K to be executed by Alton Boynton as the Company’s principal
executive officer and principal financial officer.  Additionally, the
Form 10-K will be revised to be executed by a majority of the members of the
Company’s Board of Directors.

    Exhibit
31.1

              8.

              We
      note that you filed your Principal Executive Officer and Principal
      Financial Officer certification under Item 601(b)(31) of Regulation
      S-K.  Please amend your filing to revise the certification to
      include the introductory language of paragraph 4 of Item 601(b)(31) of
      Regulation S-K to include reference to internal
      controls.  Please also amend your Forms 10-Q for the quarterly
      periods ended March 31, June 30 and September 30, 2010 to revise the
      certifications.

    We will
amend the certification to provide:

    I am
responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control
over financial reporting (as defined in Exchange Act Rules 13a-15(f) and
15d-15(f)) for the registrant and have:

              (a)

              ………..

    Form 10-Q for the quarterly
period ended September 30, 2010

    Signatures, page
26

              9.

              Pursuant
      to General Instruction G of Form 10-Q, your Form 10-Q must be signed by
      your principal executive officer, principal financial officer, controller
      or principal accounting officer, and a majority of the board of
      directors.  As it does not appear that it has been signed by a
      majority of the board of directors, you should amend your filing to
      include all required signatures.  To the extent that Mr. Boynton
      serves in the capacity as principal financial officer and controller or
      principal accounting officer, the signature block sh