SEC Company Response from NORTHWEST BIOTHERAPEUTICS INC (NWBO) (CIK 0001072379) (NWBO) — Sep 2, 2005
NORTHWEST BIOTHERAPEUTICS INC (NWBO) (CIK 0001072379)
Date: Sept. 2, 2005 · CIK: 0001072379 · Accession: 0000950124-05-005289
AI Filing Summary & Sentiment
File numbers found in text: 000-33393
Referenced dates: August 19, 2005
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September 2, 2005
Via Facsimile and U.S. Mail
Jim B. Rosenberg
Senior Assistant Chief Accountant
U.S. Securities and Exchange Commission
450 Fifth Street, N.W.
Mail Stop 6010
Washington D.C. 20549
Re: Northwest Biotherapeutics, Inc.
Form 10-K for Fiscal Year Ended December 31, 2004
Filed April 15, 2005
File No. 000-33393
Dear Mr. Rosenberg:
Thank you for your letter dated August 19, 2005 regarding the above-referenced
matter. This letter sets forth Northwest Biotherapeutics' reply. We have
repeated each of your comments in italics which are then followed by our
responses in bold.
Item 7. Management's Discussion and Analysis of Financial Condition and
... page 32
Results of Operation, page 35
1. If you still do not allocate your research and development costs on a project
basis, please provide us the following, in disclosure-type format: (a) an
explanation of why management does not maintain and evaluate these costs by
project and (b) quantitative or qualitative information indicating the amount of
your resources being used on each major project. Otherwise, please provide us,
in disclosure-type format, the costs incurred on each major project during each
period presented and incurred to date.
NORTHWEST BIOTHERAPEUTICS RESPONSE:
WE HAVE NEVER HISTORICALLY NOR DO WE CURRENTLY ALLOCATE OUR RESEARCH AND
DEVELOPMENT COSTS ON A PROJECT BASIS.
(A) WE ARE A DEVELOPMENT STAGE COMPANY THAT DOES NOT ALLOCATE RESEARCH
AND DEVELOPMENT COSTS ON A PROJECT BASIS. OUR MANAGEMENT ADOPTED
THIS POLICY, IN PART, DUE TO THE UNREASONABLE COST BURDEN ASSOCIATED
WITH ACCOUNTING AT SUCH LEVELS OF DETAIL AND OUR LIMITED NUMBER OF
RESOURCES. WE HAD TO SHIFT OUR FOCUS, STARTING IN 2002, FROM
DISCOVERING, DEVELOPING, AND COMMERCIALIZING IMMUNOTHERAPY PRODUCTS
TO CONSERVING CASH AND PRIMARILY CONCENTRATING ON SECURING NEW
WORKING CAPITAL TO RE-ACTIVATE OUR CLINICAL TRIAL PROGRAMS.
MANAGEMENT'S BUSINESS JUDGMENT HAS BEEN THAT THERE IS LITTLE VALUE
ASSOCIATED WITH EVALUATING PROJECT EXPENDITURE LEVELS SINCE ALL
PROJECTS HAD EITHER BEEN DISCONTINUED AND/OR THEIR RESPECTIVE
ACTIVITY REDUCED TO A SUBSISTENCE LEVEL. AS RESEARCH AND DEVELOPMENT
INCREASED IN 2004, THE COMPANY CONTINUED NOT TO TRACK COSTS ON A
PROJECT BASIS DUE TO RESOURCE CONSTRAINTS.
(B) BECAUSE PART OF THE YEAR 2002 WAS SPENT ACTIVELY PURSUING CLINICAL
TRIAL DEVELOPMENT WHILE THE LATTER PART OF THE YEAR INVOLVED CLOSE
DOWN ACTIVITY TO CONSERVE CASH, WE WOULD ESTIMATE THAT APPROXIMATELY
38% OF THAT YEAR'S RESOURCES WERE DEVOTED TO THE START-UP OF THREE
TRIALS. APPROXIMATELY 77% OF RESOURCES IN 2003 AND APPROXIMATELY 46%
OF RESOURCES IN 2004
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Page 2.
AVAILABLE WERE SPENT ON GENERAL & ADMINISTRATIVE ACTIVITIES FOCUSED
ON FINANCING THE COMPANY'S CONTINUED OPERATIONS.
Liquidity and Capital Resources, page 37
Uses of Cash, page 40
2. Please clarify for us how the sale of fixed assets contributed to the
decrease in your cash used in operating activities from 2003 to 2004.
NORTHWEST BIOTHERAPEUTICS RESPONSE:
THE LANGUAGE CITED IN THE COMMENT WAS INTENDED TO SERVE AS AN EXAMPLE OF
THE COMPANY'S CASH CONSERVATION EFFORTS, AND NOT AS A REASON FOR THE
DECREASE IN CASH USED IN OPERATING ACTIVITIES. TO PREVENT CONFUSION, WE
WILL EXCLUDE THIS LANGUAGE FROM FUTURE FILINGS.
Overview of Contractual Obligations, page 40
3. Please tell us how you account for third party contract research costs,
including: (a) how payments are determined, (b) when you recognize these
costs and how that compares to when you are billed or any specific
performance criteria, and (c) when payments are due.
NORTHWEST BIOTHERAPEUTICS RESPONSE:
THE MAJOR CONTRACT MANUFACTURING AGREEMENT ENTERED INTO IN 2004 RELATES
PRIMARILY TO MANUFACTURING OUR DCVAX PRODUCT CANDIDATES, REGULATORY
ADVICE, RESEARCH AND DEVELOPMENT PRECLINICAL ACTIVITIES AND MANAGING
CLINICAL TRIALS, AS SET FORTH ON PAGE 49, AGREEMENT WITH COGNATE, FORM
10-K, 2004.
(A) THIS VENDOR DETERMINES ITS COSTS IN PERFORMING ITS OBLIGATIONS UNDER
THE CONTRACT ON A MONTHLY BASIS THROUGH CAPTURING THEIR TIME,
EFFORT, AND MATERIALS EXPENDED. WE HAVE VISITED THIS VENDOR'S SITE
TO ASSESS THEIR PROGRESS AND TO CONDUCT OTHER INTERNAL AUDITS/REVIEW
OF THEIR COMPLIANCE WITH THE INTENT AND PROVISIONS OF THE CONTRACT.
(B) WE ARE INVOICED MONTHLY AT A FIXED ESTIMATED FLAT FEE FOR THE
CONTRACTED SERVICES PERFORMED WHICH IS RECOGNIZED MONTHLY AS
CONSULTING, R&D, MANUFACTURING, AND CLINICAL TRIAL EXECUTION EXPENSE
IN OUR OPERATING STATEMENT. QUARTERLY, THE VENDOR IS REQUESTED TO
PROVIDE A RECONCILIATION OF ACTUAL INCURRED EXPENSES FOR THE QUARTER
TO THEIR INVOICED EXPENSES WITH ANY RELEVANT CREDIT, OR ADDITIONAL
COST RECOGNIZED FOR THE QUARTER THEN ENDED. THIS RECONCILIATION HAS
BEEN COMPLETED FROM INCEPTION OF THE CONTRACT THROUGH THE SIX MONTHS
ENDED JUNE 30, 2005.
(C) INVOICED PAYMENTS ARE DUE MONTHLY.
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Page 3
Item 15. Exhibits, Financial Statement Schedules, page 50
Reports of Independent Registered Public Accounting Firm, pages 51 and 52
4. As both reports state that the audits were conducted in accordance with the
"auditing standards" of the PCAOB, as opposed to "the standards" of the PCAOB,
please tell us how both reports comply with paragraph 3 of PCAOB Auditing
Standard No.1. Based on the language used in the reports, it is unclear whether
the audits were conducted in accordance with the related professional practice
standards of the PCAOB. Otherwise, please provide us with reports, revised by
both auditors, that comply with paragraph 3.
NORTHWEST BIOTHERAPEUTICS RESPONSE:
WE HAVE DISCUSSED THIS WITH BOTH PETERSON SULLIVAN AND KPMG LLP AND THE
AUDITS WERE CONDUCTED IN ACCORDANCE WITH THE RELATED PROFESSIONAL PRACTICE
STANDARDS OF THE PCAOB. WE HAVE ATTACHED DRAFTS OF THE REPORTS OF EACH OF
OUR AUDITORS IN ACCORDANCE WITH PARAGRAPH 3 INDICATING THE CORRECTED
LANGUAGE. THE AUDIT REPORTS CONTAINED IN FUTURE EXCHANGE ACT REPORTS WILL
COMPLY WITH THE STAFF'S COMMENT.
5. As your current auditor has relied on the report of your predecessor auditor
regarding the cumulative period from inception through December 31, 2003, please
justify for us why the report of your predecessor auditor does not appear to
opine on the cumulative period. Otherwise, please provide us with report(s),
revised by your auditor(s), to resolve this apparent discrepancy.
NORTHWEST BIOTHERAPEUTICS RESPONSE:
AS NOTED IN RESPONSE TO THE PREVIOUS COMMENT, WE HAVE ATTACHED A DRAFT OF
THE REPORT OF KPMG WHICH OPINES ON THE CUMULATIVE PERIOD FROM INCEPTION
THROUGH DECEMBER 31, 2003. THEY DID AUDIT THIS PERIOD BUT HAD NOT INCLUDED
THE PERIOD IN THE ORIGINAL REPORT SINCE THE ACTUAL PERIOD WAS NOT
PRESENTED SEPARATELY. TO THE EXTENT THAT THIS REQUIREMENT CONTINUES TO BE
APPLICABLE, REPORTS CONTAINED IN FUTURE EXCHANGE ACT REPORTS WILL COMPLY
WITH THE STAFF'S COMMENT.
In connection with the foregoing Northwest Biotherapeutics, Inc. hereby
acknowledges:
- the company is responsible for the adequacy and accuracy of the
disclosure in its filings;
- staff comments or changes to disclosure in response to staff
comments in our filings reviewed by the staff do not foreclose the
Commission from taking any action with respect to the filing; and
- the company may not assert staff comments as a defense in any
proceeding initiated by the Commission or any person under the
federal securities laws of the United States.
If you have any questions regarding the company's responses to your comments
please do not hesitate to contact me.
Sincerely,
/s/ Alton L. Boynton
Alton L. Boynton, Ph. D., President
Northwest Biotherapeutics, Inc.
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PETERSON SULLIVAN PLLC
CERTIFIED PUBLIC ACCOUNTANTS TEL 206.382.7777 . FAX 206.382.7700
601 UNION STREET, SUITE 2300 http://www.pscpa.com
SEATTLE, WASHINGTON 98101
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors
Northwest Biotherapeutics, Inc.
Bothell, Washington
We have audited the accompanying balance sheet of Northwest Biotherapeutics,
Inc. (a development stage company) as of December 31, 2004, and the related
statements of operations, stockholders' equity (deficit), and cash flows for the
year ended December 31, 2004, and for the period from March 18, 1996 (date of
inception) to December 31, 2004. These financial statements are the
responsibility of the Company's management. Our responsibility is to express an
opinion on these financial statements based on our audit. The Company's
financial statements as of and for the year ended December 31, 2003, and for the
period from March 18, 1996 (date of inception) through December 31, 2003, were
audited by other auditors whose report, dated March 12, 2004, except as to notes
(1) and (12), which were as of April 26, 2004, expressed an unqualified opinion
on those statements and included an explanatory paragraph that referred to
substantial doubt about the Company's ability to continue as a going concern.
The financial statements for the period from March 18, 1996 (date of inception)
through December 31, 2003, reflect a net loss of $64,242 (in thousands) of the
accumulated deficit as of December 31, 2004. The other auditors' report has been
furnished to us, and our opinion, insofar as it relates to the amounts included
for such prior periods, is based solely on the report of such other auditors.
We conducted our audit in accordance with standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. The Company has determined that it
is not required to have, nor were we engaged to perform, an audit of its
internal control over financial reporting. Our audit included consideration of
internal control over financial reporting as a basis for designing audit
procedures that are appropriate in the circumstances, but not for the purpose of
expressing an opinion on the effectiveness of the Company's internal control
over financial reporting. Accordingly, we express no such opinion. An audit
includes examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by management, as well
as evaluating the overall financial statement presentation. We believe that our
audit provides a reasonable basis for our opinion.
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In our opinion, based on our audit and the report of other auditors, the
financial statements referred to above present fairly, in all material respects,
the financial position of Northwest Biotherapeutics, Inc. (a development stage
company) as of December 31, 2004, and the results of its operations and its cash
flows for the year ended December 31, 2004, and for the period from March 18,
1996 (date of inception) to December 31, 2004, in conformity with accounting
principles generally accepted in the United States.
The accompanying financial statements have been prepared assuming the Company
will continue as a going concern. As discussed in note (2) to the financial
statements, the Company has experienced recurring losses from operations since
inception, has a working capital deficit, and has a deficit accumulated during
the development stage. These conditions raise substantial doubt about the
Company's ability to continue as a going concern. Management's plans regarding
these matters are also described in note (2). The financial statements do not
include any adjustments that might result from the outcome of this uncertainty.
/s/ Peterson Sullivan PLLC
March 7, 2005, except with respect to note (13) which is as of April 12, 2005
Seattle, Washington
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Report of Independent Registered Public Accounting Firm
The Board of Directors
Northwest Biotherapeutics, Inc.:
We have audited the accompanying balance sheet of Northwest
Biotherapeutics, Inc. (a development stage company) (Company) as of December 31,
2003, and the related statements of operations, stockholders' equity (deficit)
and comprehensive loss, and cash flows for each of the years in the two-year
period ended December 31, 2003 and for the period from March 18, 1996
(inception) through December 31, 2003 (which period doesn't appear herein).
These financial statements are the responsibility of the Company's management.
Our responsibility is to express an opinion on these financial statements based
on our audits.
We conducted our audits in accordance with the standards of the Public
Company Accounting Oversight Board (United States). Those standards require that
we plan and perform the audit to obtain reasonable assurance about whether the
financial statements are free of material misstatement. An audit includes
examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the accounting
principles used and significant estimates made by management, as well as
evaluating the overall financial statement presentation. We believe that our
audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly,
in all material respects, the financial position of Northwest Biotherapeutics,
Inc. (a development stage company) as of December 31, 2003, and the results of
its operations and its cash flows for each of the years in the two-year period
ended December 31, 2003 and the period from March 18, 1996 (inception) through
December 31, 2003, in conformity with U.S. generally accepted accounting
principles.
The accompanying financial statements have been prepared assuming that the
Company will continue as a going concern. As discussed in note 2 to the
financial statements, the Company has experienced recurring losses from
operations, has a working capital deficit and has a deficit accumulated during
the development stage which raise substantial doubt about its ability to
continue as a going concern. Management's plans in regard to these matters are
also described in note 2. The financial statements do not include any
adjustments that might result from the outcome of this uncertainty.
/s/ KPMG LLP
Seattle, Washington
March 12, 2004, except as to note 2, which is as of April 26, 2004
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