NW Bio 2012 Annual Report Shows Strong Progress And Enhancement Of Leadership Position

NW Bio 2012 Annual Report Shows Strong Progress And Enhancement Of Leadership
                                   Position

PR Newswire

BETHESDA, Md., April 8, 2013

BETHESDA, Md., April 8, 2013 /PRNewswire/ -- Northwest Biotherapeutics
(NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax^®
personalized immune therapies for solid tumor cancers, filed its annual report
on Form 10K today, reporting its financial results for the year ended December
31, 2012. The report also shows strong progress in all areas of the Company's
operations, enhancing the Company's leadership position in immune therapies
for cancer.

(Logo: http://photos.prnewswire.com/prnh/20110329/SF73084LOGO)

Year End 2012 Financial Results 

During the twelve months ended December 31, 2012, the company used $22.8
million in cash for operating activities, compared to $14.7 million in cash
for operating activities during the twelve months ended December 31, 2011.
The Company incurred an overall net loss (cash and non-cash) of $67.3 million
or $5.72 per share, as compared to a net loss of $32.8 million, or $5.58 per
share, for the twelve months ended December 31, 2011.

The increase in net loss was primarily due to non-cash accounting charges
(i.e., inducement expense for debt reduction, amortization of prior stock
issuances, beneficial conversion charges and other accounting adjustments) as
well as the increased number of clinical trial sites open and recruiting
across the US in the Company's Phase III clinical trial of DCVax®-L for GBM
brain cancer, and expansion of the trial preparations in Europe, as noted
below.

Review of 2012 Progress Demonstrates Leadership In Immune Therapy Space

As described more fully below, the Company's progress during 2012 included the
following:

  omajor regulatory milestones in 3 countries (US, UK and Germany);
  osubstantial expansion of the Company's Phase III clinical trial activities
    with DCVax-L for brain cancer, in both the US and Europe;
  oinitiation of the DCVax-Direct program;
  ocommencement of a "Specials" program (similar to compassionate use) for
    brain cancer patients not eligible for the Phase III trial in the UK to
    obtain DCVax-L on a self-pay basis;
  ocompletion of a 6-month Scientific Advice process with regulators, with
    positive feedback, and application for a "Hospital Exemption" program
    (similar to compassionate use) in Germany for brain cancer patients not
    eligible for the Phase III trial to obtain DCVax-L on a self-pay basis;
  oassistance to 10 major hospital centers in Germany (including all key
    opinion leaders in brain cancer) preparing and submitting applications to
    the German healthcare system requesting authorization of reimbursement for
    DCVax-L;
  odoubling of manufacturing capacity for DCVax-L in US;
  ocompletion of extensive regulatory processes and inspections, and receipt
    of approval, for manufacturing of DCVax-L in Germany for Phase III
    clinical trial;
  oadditional regulatory processes in both UK and Germany for supply of
    DCVax-L products from Germany to UK for Phase III trial in UK;
  otechnology transfer and regulatory processes for manufacturing of DCVax-L
    in UK;
  opartnering arrangements with several large marquee partners in the US and
    Europe;
  oinitiation of manufacturing preparations in US for DCVax-Direct Phase I/II
    trial;
  oaward of a $5.5 million non-dilutive matching grant from the German
    government (one of the largest such grants ever awarded), which the
    Company plans to start drawing in Q2 of 2013;
  ocomprehensive clean-up of the Company's balance sheet (eliminating more
    than $36 million in debt);
  ofinancings totaling over $32 million;
  olisting of the Company's Common Stock and Warrants on the Nasdaq Capital
    Markets;
  oexpansion of the Company's management team with a veteran senior manager
    from big pharma, who has taken blockbuster drugs through development and
    into commercialization;
  oexpansion of the Company's Board with experts in the biotech/pharma sector
    and in manufacturing; and
  oissuance of a dozen new patents in the Company's worldwide patent
    portfolio.

The Company's cash expenditures of $22.8 million for all of these operations
in 2012 were substantially below the level of expenditures usually seen with
companies that are in large Phase III clinical trials, and/or that have
multiple product development programs under way, especially with operations on
two continents.

The Company's progress has continued to accelerate in 2013. It differentiates
NW Bio as a leader in immune therapies for cancer in multiple ways, including
the following:

  ohaving 3 distinct product lines, with 2 products at the Phase III stage,
    and the 3^rd product in the process of entering an unusually broad
    combined Phase I/II trial;
  ohaving 2 products that are each expected to be applicable to all solid
    tumor cancers (one for cases with tumors that are surgically removed and
    the other for inoperable tumors);
  ohaving manufacturing processes for 2 products that have been accepted by
    regulators for clinical trials at the Phase III level (which processes
    must be the same as will be used for commercialization) – a significant
    milestone, especially for cell therapy products;
  ohaving operations (both clinical and manufacturing) established in both
    the US and Europe, the 2 largest medical markets in the world;
  ohaving over 180 issued and pending patents worldwide;
  ohaving numerous chances to win in the near term, with 3 parallel product
    programs with ongoing value milestones;
  ohaving extensive external validations, through regulatory decisions from
    highly respected regulators in 3 countries (US, UK and Germany), and
    multiple large marquee partners.

"2012 was a watershed year for NW Bio. Years of work quietly building our key
programs reached critical mass," commented Linda F. Powers, CEO of NW
Bio."Our strong progress on so many fronts in 2012 has positioned us for
further acceleration in 2013, and sharpened our leadership position in the
immune therapy space."

Progress in Lead Program: Clinical Trial With DCVax-L for Brain Cancer

During 2012, the Company's ongoing trial with DCVax-L for Glioblastoma
multiforme (GBM) brain cancer was upgraded to Phase III trial status in the
US, and was also approved in the UK to proceed as a Phase III trial. The
trial was expanded from 240 patients to 312 patients, and significant
enhancements of the trial (including additional interim analyses) were added.
The trial expanded from 25 US sites at year end 2011, to 42 sites operating in
the US and nearly 30 sites selected and in varying stages in Europe at year
end 2012.

In the UK, the Company launched its partnering with Kings College Hospital and
Kings College London -- premiere opinion-leader institutions. Three other
premiere sites were also selected and agreed to participate in the trial,
including Queens Hospital in Birmingham, University College Hospital in
London, and Addenbroke Hospital in Cambridge.

In Germany, 24 hospital centers across the country were selected and agreed to
participate in the trial. The Company's partnership with the Fraunhofer
Institute was expanded. A $5.5 million grant was awarded by the German
government (one of the largest such grants ever awarded), providing matching
funds for up to half of the Company's trial costs and manufacturing costs
there, which the Company plans to start drawing upon in Q2 of 2013. In the
fall, 10 leading hospital centers across Germany, including all of the key
opinion leaders in brain cancer, applied to the German healthcare system for
authorization of reimbursement for DCVax-L for GBM brain cancer (which the
Company will consider pursuing on a case by case basis if the "Hospital
Exemption" is approved).

Progress in DCVax-Direct Program

The Company announced its unusually broad Phase I/II clinical trial approved
by FDA for DCVax-Direct for all solid tumor cancers. The Company initiated
manufacturing arrangements for this trial in 2012. The manufacturing involves
novel, patented processes for partial maturation of the dendritic cells
comprising the active agent of DCVax-Direct, and novel automation with
proprietary machines and systems.

The Company also entered into a Letter of Intent with Sarah Cannon Research
Institute to partner in the execution of the Phase I/II trial in the US and
UK. Sarah Cannon has a network of 700 oncology doctors, who see 75,000 new
cancer patients per year in the US and UK.

Progress in Manufacturing

Due to levels of manufacturing demand significantly higher than originally
projected for the Phase III brain cancer trial, the Company arranged for
doubling of the manufacturing capacity dedicated to production of DCVax-L in
the US. The Company's contract manufacturer, Cognate BioServices, Inc.
(Cognate) undertook the necessary construction for this doubling of capacity.

In Europe, the Company, its partner the Fraunhofer Institute, and Cognate
completed the extensive regulatory processes and the final inspections for
regulatory approval and certification for the manufacture of DCVax-L for the
clinical trial in Germany – processes totaling more than 1-1/2 years of work.
The Company, Fraunhofer, Cognate and Kings College also began the 7-month
processes for regulatory approvals and institutional approvals in both the UK
and Germany to enable the manufacturing in Germany to supply DCVax-L for the
clinical trial in the UK as well. This German supply arrangement is in
addition to the manufacturing under development in the UK. Having two
manufacturing locations in Europe will provide flexibility for capacity
management as well as risk protection.

Progress in Corporate Matters

The Company added a highly respected pharma industry veteran, Dr. Guenter
Rosskamp, to its management team as CEO of the Company's German subsidiary.
Dr. Rosskamp previously served for many years as Head of Central Nervous
System Therapeutics, and as head of Strategic Business Development, for
Schering AG (now part of Bayer AG). In those capacities, Dr. Rosskamp was
responsible for the development and commercialization of multiple drugs.

The Company expanded its Board in 2012 with highly two respected experts: Dr.
Navid Malik and Mr. Jerry Jasinowski. Dr. Malik is Head of Life Sciences
Research for Cenkos Securities Plc. in the UK, and has been one of the most
influential analysts in the UK and Europe over the last decade, covering the
life sciences industry worldwide. Mr. Jasinowski is a nationally recognized
chief executive who headed up the largest industrial trade association in the
US (the National Association of Manufacturers) for fourteen years, and has
extensive board experience across a wide range of manufacturing, technology,
and financial firms, including Fortune 1000 and Fortune 500 companies.

Progress in Intellectual Property – Patents

A dozen new patents were issued to the Company in 2012 as part of its
worldwide patent portfolio of over 180 issued and pending patents. The newly
issued patents covered a variety of subject matter, such as the proprietary
partial maturation for DCVax-Direct, the machines and systems to manufacture
DCVax-Direct, processes for enhancing the potency of dendritic cells in
general, measures of product quality, and other.

Progress in Financing

During 2012, the Company completed a comprehensive clean-up of its balance
sheet, through which it removed the vast majority of all investor debt. The
Company continued to carry trade payables incurred in the ordinary course of
business, and expects to maintain such payables on an ongoing basis.

The Company raised over $32 million in financing during 2012. This included
$12.7 million in December, pursuant to an underwritten offering under an S-1
registration statement, and a series of financings totaling $19.6 earlier in
the year. As noted above, the Company also was awarded a $5.5 million
non-dilutive matching grant from the German government earlier in the year,
which the Company plans to start drawing down in Q2 of 2013.

Following the Company's balance sheet clean-up and underwritten offering of
$12.7 million in December 2012, the Company completed the year by listing on
the Nasdaq Capital Markets after a decade listed on the Bulletin Board. The
Company's stock began trading on Nasdaq on December 7, 2012.

As of December 31, 2012, the Company had an aggregate accumulated cash deficit
of $140 million, since inception of the Company in 1996, and accumulated
non-cash (accounting measures) deficit of $179.1 million. Accordingly, the
Company's combined cash and non-cash accumulated deficit is $319.1 million
since the Company's inception.

When the Company begins having taxable income, this $319.1 million deficit
should provide corresponding tax benefits as Net Operating Loss (NOL)
carryforwards.

About Northwest Biotherapeutics

Northwest Biotherapeutics is a biotechnology company focused on developing
immunotherapy products to treat cancers more effectively than current
treatments, without toxicities of the kind associated with chemotherapies, and
on a cost-effective basis, in both the United States and Europe. The Company
has a broad platform technology for DCVax dendritic cell-based vaccines. The
Company's lead program is a 312-patient Phase III trial in newly diagnosed
Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of
brain cancer. The Company also previously received clearance from the FDA for
a 612-patient Phase III trial in prostate cancer, and clearance from the FDA
for Phase I/II trials in multiple other cancers. The Company also conducted a
Phase I/II trial with DCVax for metastatic ovarian cancer together with the
University of Pennsylvania.

Disclaimer

Statements made in this news release that are not historical facts, including
statements concerning future treatment of patients using DCVax and future
clinical trials, are forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Words such as "expect,"
"believe," "intend," "plan," "continue," "may," "will," "anticipate," and
similar expressions are intended to identify forward-looking statements.
Actual results may differ materially from those projected in any
forward-looking statement. Specifically, there are a number of important
factors that could cause actual results to differ materially from those
anticipated, such as the Company's ability to raise additional capital, risks
related to the Company's ability to enroll patients in its clinical trials and
complete the trials on a timely basis, the uncertainty of the clinical trials
process, uncertainties about the timely performance of third parties, and
whether the Company's products will demonstrate safety and efficacy.
Additional information on these and other factors, including Risk Factors,
which could affect the Company's results, is included in its Securities and
Exchange Commission ("SEC") filings. Finally, there may be other factors not
mentioned above or included in the Company's SEC filings that may cause actual
results to differ materially from those projected in any forward-looking
statement. You should not place undue reliance on any forward-looking
statements. The Company assumes no obligation to update any forward-looking
statements as a result of new information, future events or developments,
except as required by securities laws.

(Financial Information to Follow)



NORTHWEST BIOTHERAPEUTICS, INC.
(A Development Stage Company)
CONSOLIDATED BALANCE SHEET
(in thousands, except per share data)
                                                    December31,
                                                    2012          2011
ASSETS
Current assets:
Cash and cash equivalents                           $ 7,346       $ 24
Prepaid expenses and other current assets             112           94
Total current assets                                  7,458         118
Property and equipment:
Laboratory equipment                                  60            29
Office furniture and other equipment                  172           172
Less accumulated depreciation and amortization        (137)         (123)
Property and equipment, net                           95            78
Deposit and other non-current assets                  17            16
Total assets                                        $ 7,570       $ 212
LIABILITIES, REDEEMABLE COMMON STOCK AND STOCKHOLDERS' DEFICIT
Current liabilities:
Accounts payable (includes related party of $3,397  $ 8,165       $ 3,808
and $1,589 in 2012 and 2011, respectively)
Accrued expenses (includes related party of $28       589           2,815
and $630 in 2012 and 2011, respectively)
Note payable (includes related party of $0 and        934           5,205
$2,056 in 2012 and 2011, respectively)
Convertible notes, net (includes related party of     1,056         8,420
$0 and $3,588 in 2012 and 2011, respectively)
Embedded derivative liability                         -             601
Liability for reclassified equity contracts           -             29,903
Total current liabilities                             10,744        50,752
Non-current liabilities:
Notes payable                                         -             200
Convertible notes payable, net                        1,882         1,433
Total long term liabilities                           1,882         1,633
Total liabilities                                     12,626        52,385
Redeemable common stock ($0.001 par value)            11,017        -
Stockholders' deficit:
Preferred stock ($0.001 par value); 40,000,000 and
20,000,000 shares authorized; 0 and 0 shares          -             -
issued and outstanding as of December 31, 2012 and
December 31, 2011, respectively
Common stock ($0.001 par value); 450,000,000 and
150,000,000 shares authorized; 26,545,828 and
9,334,101 shares issued and outstanding as of         27            150
December 31, 2012 and December 31, 2011,
respectively
Additional paid-in capital                            303,188       199,605
Deficit accumulated during the development stage      (319,098)     (251,778)
Cumulative translation adjustment                     (190)         (150)
Total stockholders' deficit                           (16,073)      (52,173)
Total liabilities, redeemable common stock and      $ 7,570       $ 212
stockholders' deficit





NORTHWEST BIOTHERAPEUTICS, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
                                                            Period from
                                 Years Ended December 31,   Inception (March
                                                            18,
                                                            1996) to
                                 2012          2011         December 31, 2012
Revenues:
Research material sales          $  -          $ 10         $     580
Contract research and
development from related            -            -                1,128
parties
Research grants and other           772          -                1,833
Total revenues                      772          10               3,541
Operating cost and expenses:
Cost of research material sales     -            -                382
Research and development            28,908       13,452           119,172
General and administration          15,675       13,335           90,999
Depreciation and amortization       14           10               2,377
Loss on facility sublease           -            -                895
Asset impairment loss               -            -                2,445
Total operating costs and           44,597       26,797           216,270
expenses
Loss from operations                (43,825)     (26,787)         (212,729)
Other income (expense):
Valuation of reclassified           491          8,821            16,071
equity instruments
Conversion inducement expense       (9,103)      (7,944)          (27,337)
Accretion of redeemable            (2,042)      -                (2,042)
securities
Derivative valuation                601          728              1,383
gain/(loss)
Gain on sale of intellectual
property and property and           -            -                3,664
equipment
Interest expense                    (13,442)     (7,648)          (55,006)
Interest income and other           -            -                1,707
Net loss                            (67,320)     (32,830)         (274,289)
Issuance of common stock in
connection with elimination of      -            -                (12,349)
Series A and Series A-1
preferred stock preferences
Modification of Series A            -            -                (2,306)
preferred stock warrants
Modification of Series A-1          -            -                (16,393)
preferred stock warrants
Series A preferred stock            -            -                (334)
dividends
Series A-1 preferred stock          -            -                (917)
dividends
Warrants issued on Series A and
Series A-1 preferred stock          -            -                (4,664)
dividends
Accretion of Series A preferred
stock mandatory redemption          -            -                (1,872)
obligation
Series A preferred stock            -            -                (1,700)
redemption fee
Beneficial conversion feature       -            -                (4,274)
of Series D preferred stock
Net loss applicable to common    $  (67,320)   $ (32,830)   $     (319,098)
stockholders
Net loss per share applicable    $  (5.72)     $ (5.58)
to common stockholders - basic
Weighted average shares used        11,759       5,887
computing basic loss per share





SOURCE Northwest Biotherapeutics

Website: http://www.nwbio.com
Contact: Les Goldman, +1-202-841-7909, lgoldman@nwbio.com; or Beverly Jedynak,
+1-312-943-1123, bjedynak@janispr.com, www.nwbio.com
 
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