Delaware | 2834 | 94-3306718 | ||
(State or other jurisdiction of
incorporation or organization) |
(Primary Standard Industrial
Classification Code Number) |
(I.R.S. Employer
Identification Number) |
The
information in this prospectus is not complete and may be
changed. These securities may not be sold until the registration
statement filed with the Securities and Exchange Commission is
effective. This prospectus is not an offer to sell nor does it
seek an offer to buy these securities in any jurisdiction where
the offer or sale is not
permitted.
|
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70
F-1
EXHIBIT 3.1
EXHIBIT 23.1
EXHIBIT 23.2
Table of Contents
1
Table of Contents
2
3
4
58,969,641 shares
65,241,287 shares
We intend to use the net proceeds that we receive from this
offering, if any, for working capital and other general
corporate purposes. We will not receive any of the proceeds from
the sale of shares by the selling stockholders unless warrants
are exercised for cash. See Use of Proceeds.
NWBT.OB
an aggregate of 543,923 shares of common stock issuable
upon exercise of options outstanding at July 6, 2006,
granted under our 1998 Stock Option Plan, the 1999 Executive
Stock Option Plan, the 2001 Stock Option Plan, the Employee
Stock Purchase Plan and the 2001 Nonemployee Director Stock
Incentive Plan, at a weighted average exercise price of
$0.64 per share;
an aggregate of 4,149,859 additional shares of common stock
reserved for future grants under our 1998 Stock Option Plan, the
1999 Executive Stock Option Plan, the 2001 Stock Option Plan,
the Employee Stock Purchase Plan and the 2001 Nonemployee
Director Stock Incentive Plan;
an aggregate of 166,374,881 shares of common stock issuable
upon exercise of warrants outstanding at July 6, 2006,
including the 19,019,659 shares of common stock issuable
upon exercise of warrants held by certain selling stockholders
named in this prospectus;
an aggregate of 225,174,520 shares of common stock issuable
upon conversion of Series A and Series A-1 Preferred
Stock outstanding at July 6, 2006; and
an aggregate of 24,962,269 shares of common stock issuable
upon conversion of convertible promissory notes outstanding at
July 6, 2006.
Table of Contents
Period from
March 18, 1996
Year Ended
Three Months Ended
(Inception) to
December 31,
March 31,
March 31,
2003
2004
2005
2005
2006
2006
$
529
$
390
$
124
$
87
$
$
2,639
79
40
12
2
382
1,624
3,621
4,469
1,315
427
32,494
4,059
2,845
2,005
464
427
31,121
207
132
63
24
10
2,276
174
895
904
130
2,066
7,047
6,768
6,549
1,805
864
69,234
(6,518
)
(6,378
)
(6,425
)
(1,718
)
(864
)
(66,595
)
(368
)
(2,113
)
(2,481
)
816
3,656
(73
)
(1,765
)
(3,517
)
(809
)
(982
)
(14,119
)
23
3
5
1
1
737
(5,752
)
(8,508
)
(9,937
)
(2,526
)
(3,958
)
(78,802
)
(1,872
)
(1,700
)
(4,274
)
$
(5,752
)
$
(8,508
)
$
(9,937
)
$
(2,526
)
$
(3,958
)
$
(86,648
)
$
(0.30
)
$
(0.45
)
$
(0.52
)
$
(0.13
)
$
(0.21
)
18,908
19,028
19,068
19,035
19,230
Table of Contents
December 31,
March 31,
2003
2004
2005
2006
$
255
$
248
$
352
$
2,941
$
(392
)
$
(5,353
)
$
(11,502
)
$
(18,968
)
$
871
$
558
$
631
$
3,162
$
49
$
12
$
3
$
1
$
16
$
(5,217
)
$
(11,418
)
$
(18,893
)
Table of Contents
We will need to raise additional capital, which may not be available. |
Our auditors have issued a going concern audit opinion. |
We have reduced business umbrella, auto, crime and fiduciary, and directors and officers liability insurance coverage. |
5
We expect to continue to incur substantial losses, and we may never achieve profitability. |
| $5.8 million in 2003; | |
| $8.5 million in 2004; | |
| $9.9 million in 2005; and | |
| $4.0 million for the three months ended March 31, 2006. |
As a company in the early stage of development with an unproven business strategy, our limited history of operations makes an evaluation of our business and prospects difficult. |
| $529,000 in 2003; | |
| $390,000 in 2004; | |
| $124,000 in 2005; and | |
| $0 for the three months ended March 31, 2006. |
| the sale of research products to a single customer; | |
| contract research and development from related parties; and | |
| research grants. |
We may not be able to retain existing personnel. |
6
We have no manufacturing capabilities, which could adversely impact our ability to commercialize our product candidates. |
Because we lack sales and marketing experience, we may experience significant difficulties commercializing our research product candidates. |
Our success partially depends on existing and future collaborators. |
| may not commit sufficient resources to our programs or product candidates; | |
| may not conduct their agreed activities on time, or at all, resulting in delay or termination of the development of our product candidates and technology; | |
| may not perform their obligations as expected; | |
| may pursue product candidates or alternative technologies in preference to ours; or | |
| may dispute the ownership of products or technology developed under our collaborations. |
7
Competition in our industry is intense and most of our competitors have substantially greater resources than we have. |
| biopharmaceutical companies; | |
| biotechnology companies; | |
| pharmaceutical companies; | |
| academic institutions; and | |
| other research organizations. |
| obtain additional funding; | |
| successfully complete clinical trials and obtain all requisite regulatory approvals; | |
| maintain a proprietary position in our technologies and products; | |
| attract and retain key personnel; and | |
| maintain existing or enter into new collaborations. |
8
Our intellectual property rights may not provide meaningful commercial protection for our research products or product candidates, which could enable third parties to use our technology, or very similar technology, and could reduce our ability to compete in the market. |
Our success will depend partly on our ability to operate without infringing or misappropriating the proprietary rights of others. |
9
Toucan Capital and Toucan Partners beneficially own the vast majority of our stock and, as a result, the trading price for our shares may be depressed and these stockholders can take actions that may be adverse to your interests. |
10
There may not be an active, liquid trading market for our common stock. |
| limited release of the market price of our securities; | |
| limited news coverage; | |
| limited interest by investors in our securities; | |
| volatility of our stock price due to low trading volume; | |
| increased difficulty in selling our securities in certain states due to blue sky restrictions; and | |
| limited ability to issue additional securities or to secure additional financing. |
Our common stock may experience extreme price and volume fluctuations, which could lead to costly litigation for us and make an investment in us less appealing. |
| announcements of technological innovations or new products by us or our competitors; | |
| development and introduction of new cancer therapies; | |
| media reports and publications about cancer therapies; | |
| announcements concerning our competitors or the biotechnology industry in general; | |
| new regulatory pronouncements and changes in regulatory guidelines; | |
| general and industry-specific economic conditions; | |
| changes in financial estimates or recommendations by securities analysts; and | |
| changes in accounting principles. |
Our incorporation documents, and bylaws and stockholder rights plan may delay or prevent a change in our management. |
11
| authorize the issuance of preferred stock that can be created and issued by the board of directors without prior stockholder approval, commonly referred to as blank check preferred stock, with rights senior to those of common stock; | |
| authorize our board of directors to issue dilutive shares of common stock upon certain events; and | |
| provide for a classified board of directors. |
The resale, or the availability for resale, of the shares issued in the PIPE Financing could have a material adverse impact on the market price of our common stock. |
Because our common stock is subject to penny stock rules, the market for the common stock may be limited. |
| must make a special written suitability determination for the purchaser; | |
| receive the purchasers written agreement to a transaction prior to sale; | |
| provide the purchaser with risk disclosure documents which identify certain risks associated with investing in penny stocks and which describe the market for these penny stocks as well as a purchasers legal remedies; and | |
| obtain a signed and dated acknowledgment from the purchaser demonstrating that the purchaser has actually received the required risk disclosure document before a transaction in a penny stock can be completed. |
12
13
High | Low | ||||||||
Year Ending December 31, 2004
|
|||||||||
First Quarter
|
$ | 0.28 | $ | 0.12 | |||||
Second Quarter
|
$ | 0.15 | $ | 0.02 | |||||
Third Quarter
|
$ | 0.09 | $ | 0.02 | |||||
Fourth Quarter
|
$ | 0.06 | $ | 0.03 | |||||
Year Ending December 31, 2005
|
|||||||||
First Quarter
|
$ | 0.70 | $ | 0.03 | |||||
Second Quarter
|
$ | 0.26 | $ | 0.16 | |||||
Third Quarter
|
$ | 0.22 | $ | 0.13 | |||||
Fourth Quarter
|
$ | 0.17 | $ | 0.09 | |||||
Year Ending December 31, 2006
|
|||||||||
First Quarter
|
$ | 0.69 | $ | 0.09 | |||||
Second Quarter
|
$ | 0.55 | $ | 0.22 | |||||
Third Quarter (through July 10, 2006)
|
$ | 0.21 | $ | 0.27 |
14
Three Months | Period from | ||||||||||||||||||||||||||||||||||
Years Ended December 31, | Ended March 31, | March 18, 1996 | |||||||||||||||||||||||||||||||||
(Inception) to | |||||||||||||||||||||||||||||||||||
2001 | 2002 | 2003 | 2004 | 2005 | 2005 | 2006 | March 31, 2006 | ||||||||||||||||||||||||||||
(In thousands, except per share data) | |||||||||||||||||||||||||||||||||||
Statement of Operations Data:
|
|||||||||||||||||||||||||||||||||||
Total Revenues
|
$ | 129 | $ | 9 | $ | 529 | $ | 390 | $ | 124 | $ | 87 | $ | | $ | 2,639 | |||||||||||||||||||
Operating Costs and Expenses
|
|||||||||||||||||||||||||||||||||||
Cost of research material sales
|
67 | 7 | 79 | 40 | 12 | 2 | | 382 | |||||||||||||||||||||||||||
Research and development
|
4,907 | 5,956 | 1,624 | 3,621 | 4,469 | 1,315 | 427 | 32,494 | |||||||||||||||||||||||||||
General and administrative
|
4,759 | 7,463 | 4,059 | 2,845 | 2,005 | 464 | 427 | 31,121 | |||||||||||||||||||||||||||
Depreciation and amortization
|
467 | 593 | 207 | 132 | 63 | 24 | 10 | 2,276 | |||||||||||||||||||||||||||
Loss on facility sublease
|
| 721 | 174 | | | | | 895 | |||||||||||||||||||||||||||
Asset impairment loss
|
| 1,032 | 904 | 130 | | | | 2,066 | |||||||||||||||||||||||||||
Total operating costs and expenses
|
10,200 | 15,772 | 7,047 | 6,768 | 6,549 | 1,805 | 864 | 69,234 | |||||||||||||||||||||||||||
Loss from operations
|
(10,071 | ) | (15,763 | ) | (6,518 | ) | (6,378 | ) | (6,425 | ) | (1,718 | ) | (864 | ) | (66,595 | ) | |||||||||||||||||||
Other Income (expense), net
|
|||||||||||||||||||||||||||||||||||
Warrant valuation
|
| | | (368 | ) | | | (2,113 | ) | (2,481 | ) | ||||||||||||||||||||||||
Gain on sale of intellectual property to Medarex
|
| 2,840 | 816 | | | | | 3,656 | |||||||||||||||||||||||||||
Interest expense
|
(1,062 | ) | (38 | ) | (73 | ) | (1,765 | ) | (3,517 | ) | (809 | ) | (982 | ) | (14,119 | ) | |||||||||||||||||||
Interest income
|
193 | 157 | 23 | 3 | 5 | 1 | 1 | 737 | |||||||||||||||||||||||||||
Net loss
|
(10,940 | ) | (12,804 | ) | (5,752 | ) | (8,508 | ) | (9,937 | ) | (2,526 | ) | (3,958 | ) | (78,802 | ) | |||||||||||||||||||
Accretion of redemption value of mandatorily redeemable
membership units and preferred stock
|
(379 | ) | | | | | | | (1,872 | ) | |||||||||||||||||||||||||
Series A preferred stock redemption fee
|
(1,700 | ) | | | | | | | (1,700 | ) | |||||||||||||||||||||||||
Beneficial conversion feature of series D convertible
preferred stock
|
(4,274 | ) | | | | | | | (4,274 | ) | |||||||||||||||||||||||||
Net loss applicable to common stockholders
|
$ | (17,293 | ) | $ | (12,804 | ) | $ | (5,752 | ) | $ | (8,508 | ) | $ | (9,937 | ) | $ | (2,526 | ) | $ | (3,958 | ) | $ | (86,648 | ) | |||||||||||
Net loss per share applicable to common Stockholders
basic and diluted
|
$ | (6.57 | ) | $ | (0.76 | ) | $ | (0.30 | ) | $ | (0.45 | ) | $ | (0.52 | ) | $ | (0.13 | ) | $ | (0.21 | ) | ||||||||||||||
Weighted average shares used in computering basic and diluted
net loss per share
|
2,631 | 16,911 | 18,908 | 19,028 | 19,068 | 19,035 | 19,230 | ||||||||||||||||||||||||||||
15
December 31,
March 31,
2001
2002
2003
2004
2005
2006
(In thousands)
$
14,966
$
2,539
$
255
$
248
$
352
$
2,941
13,501
3,466
(392
)
(5,353
)
(11,502
)
(18,968
)
19,476
7,572
871
558
631
3,162
123
378
49
12
3
1
16,935
4,876
16
(5,217
)
(11,418
)
(18,893
)
16
17
| the issuance of a series of convertible promissory notes to Toucan Capital in aggregate principal amount of approximately $6.75 million (and associated warrants to purchase an aggregate of 122.5 million shares of capital stock at exercise prices ranging from 0.01 to $0.04 per share) from February 2004 through September 2005. These notes accrued interest at 10% per annum from the respective issuance dates of the notes; | |
| the issuance of a convertible promissory note to Toucan Partners, in principal amount of $400,000 (and an associated warrant to purchase an aggregate of 4 million shares of capital stock at an exercise price of $0.04 per share) in November 2005. This note accrues interest at 10% per annum from the issuance date of the note; | |
| the issuance of a series of non-convertible promissory notes to Toucan Partners, in the aggregate principal amount of $550,000. These notes accrue interest at 10% per annum from the respective issuance dates of the notes; | |
| the sale of Series A Preferred Stock to Toucan Capital for aggregate gross proceeds of approximately $1.3 million (and an associated warrant to purchase an aggregate of 13 million shares of Series A Preferred Stock at an exercise price of $0.04 per share) in January 2005; and | |
| the sale of approximately 39.5 million shares of common stock (and accompanying warrants to purchase an aggregate of approximately 19.7 shares of common stock at an exercise price of $0.14 per share) to certain accredited investors in the PIPE Financing for aggregate gross proceeds of approximately $5.5 million in April 2006. |
18
| an aggregate of 32.5 million shares of Series A Preferred Stock (convertible into an aggregate of 32.5 million shares of common stock as of July 6, 2006); | |
| an aggregate of approximately 4.82 million shares of Series A-1 Preferred Stock (convertible into an aggregate of approximately 192.7 million shares of common stock as of July 6, 2006); | |
| warrants to purchase an aggregate of 66 million shares of capital stock at an exercise price of $0.01 per share; | |
| warrants to purchase an aggregate of 56.5 million shares of capital stock at an exercise price of $0.04 per share; and | |
| warrants to purchase an aggregate of 13 million shares of Series A Preferred Stock at an exercise price of $0.04 per share. |
| convertible promissory notes in aggregate principal amount of $950,000, with accrued interest thereon of approximately $48,000 as of July 6, 2006 (with such notes convertible as of July 6, 2006 into an aggregate of approximately 25.0 million shares of capital stock at a conversion price of $0.04 per share); and | |
| warrants to purchase an aggregate of 9.5 million shares of capital stock at an exercise price of $0.04 per share. |
| an aggregate of approximately 39.9 million shares of common stock; and | |
| warrants to purchase an aggregate of approximately 19.0 million shares of common stock at an exercise price of $0.14 per share. |
19
(i) is entitled to cumulative dividends at the rate of 10% per year; | |
(ii) is entitled to a liquidation preference in the amount of its initial purchase price plus all accrued and unpaid dividends (to the extent of legally available funds); | |
(iii) has a preference over the common stock, and is on a pari passu basis with the Series A-1 Preferred Stock, with respect to dividends and distributions; | |
(iv) is entitled to participate on an as-converted basis with the common stock on any distributions after the payment of any preferential amounts to the Series A Preferred Stock and the Series A-1 Preferred Stock; | |
(v) votes on an as converted basis with the common stock and the Series A-1 Preferred Stock on matters submitted to the common stockholders for approval and as a separate class on certain other material matters; and | |
(vi) is convertible into common stock on a one-for-one basis (subject to adjustment in the event of stock dividends, stock splits, reverse stock splits, recapitalizations, etc.). |
20
Date
Loan Principal
Due Date
Interest Rate
(In thousands)
$
400
11/14/06
10%
250
12/30/06
10%
300
03/09/07
10%
$
950
Toucan Capital |
Issuance Date | Warrant Shares(1) | |||
(In thousands) | ||||
04/26/04
|
36,000 | (2) | ||
06/11/04
|
30,000 | (2) | ||
07/30/04
|
20,000 | (3) | ||
10/22/04
|
5,000 | (3) | ||
11/10/04
|
5,000 | (3) | ||
12/27/04
|
2,500 | (3) | ||
04/12/05
|
4,500 | (3) | ||
05/13/05
|
4,500 | (3) | ||
06/16/05
|
5,000 | (3) | ||
07/26/05
|
5,000 | (3) | ||
09/07/05
|
5,000 | (3) | ||
Total
|
122,500 | |||
(1) | These warrants have a seven year exercise period from their respective issuance dates. The foregoing warrants are exercisable for shares of convertible preferred stock if other investors have purchased in cash a minimum of $15 million of such convertible preferred stock, on the terms and conditions set forth in the recapitalization agreement. However, if, other investors have not purchased in cash a minimum of $15 million of such convertible preferred stock, on the terms and conditions set forth in the Recapitalization Agreement, these warrants shall be exercisable for any equity security and/or debt security and/or any combination thereof. As a result, these warrants are currently exercisable at the holders election, for shares of common stock or Series A Preferred Stock, or Series A-1 Preferred Stock. |
(2) | Per share exercise price is $0.01 for common stock or Series A Preferred Stock or $0.40 per share for Series A-1 Preferred Stock. |
21
(3) | Per share exercise price is $0.04 for common stock or Series A Preferred Stock or $1.60 per share for Series A-1 Preferred Stock. |
Toucan Partners |
Issuance Date | Shares | |||
(In thousands)(1) | ||||
11/14/05
|
4,000 | |||
04/17/06
|
5,500 | |||
Total
|
9,500 | |||
(1) | These warrants have a seven year exercise period from their respective issuance dates. The foregoing warrants are exercisable for shares of convertible preferred stock if other investors have purchased in cash a minimum of $15 million of such convertible preferred stock, on the terms and conditions set forth in our recapitalization agreement. However, if, other investors have not purchased in cash a minimum of $15 million of such convertible preferred stock, on the terms and conditions set forth in the recapitalization agreement, these warrants shall be exercisable for any equity security and/or debt security and/or any combination thereof. As a result, these warrants are currently exercisable at the holders election, for shares of common stock or Series A Preferred Stock, or Series A-1 Preferred Stock. Per share exercise price is $0.04 for common stock or Series A Preferred Stock or $1.60 per share for Series A-1 Preferred Stock. |
22
Restructuring liabilities. |
Impairment of Long-Lived Assets |
Stock-Based Compensation |
23
Revenue recognition |
Operating costs: |
Research and development: |
24
General and administrative: |
25
26
27
General Discussion |
28
29
Federal Grants |
Research Reagent Sales |
License Fees |
30
Management Loans |
Toucan Capital Loans |
Toucan Capital Series A Cumulative Convertible Preferred Stock |
Toucan Partners Loans |
PIPE Financing |
31
Uses of Cash |
32
Payments Due by Period | |||||||||||||||||||||
Less Than | More Than | ||||||||||||||||||||
Contractual Obligation | Total | 1 Year | 1-3 Years | 3-5 Years | 5 Years | ||||||||||||||||
(In thousands) | |||||||||||||||||||||
Loans(1)
|
$ | 7,700 | $ | 7,700 | $ | | $ | | $ | | |||||||||||
Contract Manufacturing Agreement(2)
|
2,873 | 2,873 | | | | ||||||||||||||||
Capital Lease Obligations
|
8 | 7 | 1 | | | ||||||||||||||||
Operating Lease Obligations
|
219 | 219 | | | | ||||||||||||||||
Total
|
$ | 10,800 | $ | 10,799 | $ | 1 | $ | | $ | | |||||||||||
(1) | An aggregate of $6.75 million of these loans represents amounts payable to Toucan Capital pursuant to a series of convertible promissory notes which, subsequent to March 31, 2006, have been converted into shares of Series A-1 Preferred Stock. The remaining $950,000 of these loans represents amounts payable to Toucan Partners pursuant to a series of convertible promissory notes. |
(2) | On July 30, 2004, we entered an agreement with Cognate Therapeutics, Inc. The agreement includes a penalty of $2 million if cancelled after one year as well as payment for all services performed in winding down any ongoing activities. |
33
34
Incidence of Cancer in the United States |
Type of Cancer | New Cases | Deaths | ||||||
Breast
|
211,240 | 40,410 | ||||||
Prostate
|
232,090 | 30,350 | ||||||
Colorectal
|
145,290 | 56,290 | ||||||
Lung
|
172,570 | 163,510 | ||||||
Kidney
|
36,160 | 12,660 | ||||||
Melanoma
|
59,580 | 7,770 | ||||||
Brain
|
17,000 | 12,760 |
35
| Step 1. Dendritic cells ingest cancer antigens, break them into small fragments and display them on their outer cell surfaces. | |
| Step 2. Dendritic cells bearing these cancer antigen fragments bind to and activate naive T cells, which become disease-specific Helper T and Killer T cells. | |
| Step 3. The activated Helper T cells produce factors that greatly enhance the cell division of Killer T cells and mature their cancer-killing properties. | |
| Step 4. Cancer cells and their cancer-associated antigens are also recognized by antibody-producing B cells. | |
| Step 5. The activated Helper T cells produce factors that greatly enhance antibody production by B cells that in turn are specific for the cancer-associated antigens. | |
| Step 6. The Killer T cells and antibodies, acting alone or in combination, destroy cancer cells. |
Traditional Cancer Therapy Approaches |
| Surgery. Surgery may be used to remove cancer cells, but not all cancer cells can be removed surgically. Surgery may also result in significant adverse side effects such as collateral damage to healthy tissue, bleeding and infection. | |
| Radiation Therapy. Radiation therapy may be used to treat cancers but it can cause significant damage to healthy tissue surrounding the targeted cancer cells. Recurrent cancers may not be treatable with further radiation therapy. Radiation therapy may also cause additional significant adverse side effects such as burns to treated skin, organ damage and hair loss. |
36
| Chemotherapy. Chemotherapy may be used to treat cancer, but involves the use of toxic chemical agents. These toxic chemical agents affect both healthy and diseased cells and may cause additional significant adverse side effects such as hair loss, immune suppression, nausea and diarrhea. | |
| Hormone Therapy. Hormone therapy may be used to treat cancer, but involves the use of substances that chemically inhibit the production of growth and reproductive hormones and is also limited in effectiveness. Hormone therapy may cause significant adverse side effects such as bone loss, hot flashes, impotence and blood clots. |
| Antibody-Based Therapies. Currently approved antibody-based cancer therapies have improved survival rates with reduced side effects when compared with traditional therapies. However, these antibody-based therapies can elicit an immune response against themselves because they contain mouse proteins or fragments of such proteins. This can limit their effectiveness and potentially cause toxic side effects. | |
| Immune-Modulating Agents. Currently approved immune-modulating agents, such as IL-2, GM-CSF and alpha-interferon, are known to have some ability to enhance the immune system and control cancer growth. However, these therapies involve delivery of the immune modulating agent through the blood system and therefore cannot be directed exclusively to cancer cells. This lack of selectivity may result in significant toxicity to healthy tissue. |
| Activates The Natural Immune System. Our DCVax ® product candidates are designed to elicit a natural immune response. We believe that our pre-clinical and clinical trials have demonstrated that our DCVax ® product candidates can train a patients own Killer T cells to seek and destroy specifically targeted cancer cells. Our clinical trials have also shown that DCVax ® -Prostate stimulates the body to produce antibodies and T cells that bind to cancer-associated antigens and potentially destroy cancer cells marked by these antigens. | |
| Multiple Cancer Targets. If we secure the necessary funding, we intend to apply our DCVax ® platform to treat a wide variety of cancers. The DCVax ® platform affords the flexibility to target many different forms of cancer through the pairing of dendritic cells with cancer-associated antigens, fragments of cancer-associated antigens or deactivated whole cancer cells as well as possible direct intra-tumoral injection of partially mature dendritic cells. |
37
| No Significant Adverse Side Effects Or Toxicity. Our initial DCVax ® -Prostate Phase I/ II clinical trial has shown mild injection site reactions, which were typical and fully anticipated, but no significant adverse side effects in over 110 clinically administered injections. We believe that we minimize the potential for toxicity by using the patients own cells to create our DCVax ® product candidates. Additionally, because our DCVax ® products are designed to target the cancer-associated antigens in the patient, we believe they minimize collateral damage to healthy cells. | |
| Rapid Pre-Clinical Development. We believe that our DCVax ® technology, which was observed to be well tolerated in a Phase I/ II clinical trial for prostate cancer, and two Phase I clinical trials for brain cancer, will enable us to rapidly move new potential products into clinical trials within six to nine months of concept, subject to FDA approval and the availability of adequate resources. New DCVax ® product candidates simply require the identification of cancer-associated antigens, fragments of cancer-associated antigens or whole cancer cells added to partially mature dendritic cells prior to injection into patients or potentially the direct injection of partially mature dendritic cells into solid tumors. | |
| Ease Of Administration. We initially collect a sample of a patients white blood cells in a single standard outpatient procedure called leukapheresis. After patient-specific manufacturing and quality control testing, each small dose of a DCVax ® product candidate is administered by a simple intradermal injection in an outpatient setting, or by a direct injection of partially mature dendritic cell into a solid tumor. | |
| Complementary With Other Treatments. Our DCVax ® product candidates are designed to stimulate the patients own immune system to safely target cancer cells. Consequently, we believe these products may be used as an adjuvant to traditional therapies such as chemotherapy, radiation therapy, hormone therapy and surgery. |
| Fully Human Antibodies. Current monoclonal antibody-based therapies contain mouse proteins or fragments of such proteins. Consequently, these therapies have the potential to elicit unwanted immune responses against the mouse proteins or protein fragments. Our first therapeutic antibody product candidate, which was co-developed with and acquired by Medarex, is based on monoclonal antibodies that are fully human, and thus do not contain any mouse proteins. As a result, we expect these products to exhibit a favorable safety profile and minimal, if any, unwanted immune response against the antibody-based therapy itself. | |
| Rapid Pre-Clinical Development. We believe that, subject to FDA approval and the availability of adequate resources, we could progress from antigen discovery to clinical trials for each new therapeutic antibody product candidate in less than two years. | |
| Cancer Specificity. Our proprietary antigens are significantly over-expressed in cancer cells. Our antibodies bind to these targeted cancer-associated antigens and potentially destroy cancer cells marked by these antigens. To date, we have identified three clinically validated antigens associated with twelve different cancers. Certain rights to three of our antigen targets have been acquired by Medarex. |
38
| Multiple Therapeutic Applications. We believe that therapeutic antibodies may be used as stand-alone products that bind to cancer-associated antigens and potentially destroy cancer cells marked by these antigens. Therapeutic antibodies may also enable the targeted delivery of existing therapies such as radiation and cytotoxic agents. The inherent toxic effects of cytotoxic agents and radioactive materials on normal tissue could be minimized by coupling these agents to antibodies that have a high degree of specificity to cancer cells. | |
| Commercialization. Based on our experience with the manufacturing of therapeutic antibodies, we believe the manufacturing of these antibodies can be scaled to meet market demand. Antibody-based products are typically characterized by an inherent stability, resulting in a commercially acceptable shelf-life. | |
| Complementary With Other Treatments. We believe that our therapeutic antibody product candidates may be suitable for use alone or in combination with currently approved therapies due to their complementary cell-killing properties. |
39
Product Candidate | Target Indications | Status(1) | ||
DCVax
®
Platform
|
||||
DCVax
®
-Prostate
|
Prostate Cancer | Phase III Clinical Trial cleared FDA For non-metastatic hormone independent prostate cancer | ||
DCVax
®
-Brain
|
Glioblastoma multiforme | Phase II Clinical Trial cleared FDA For Glioblastoma multiforme Orphan Drug designation granted 12/02 | ||
DCVax
®
-Lung
|
Non-small cell lung cancer | Phase I Clinical Trial cleared FDA for non-small cell lung cancer | ||
DCVax
®
-Direct
|
Ovarian and three other cancers | Phase I Clinical Trial cleared FDA for ovarian cancer | ||
DCVax
®
-L
|
Ovarian | Phase I Clinical Trial cleared FDA for ovarian cancer | ||
Therapeutic Antibody Platform
|
||||
CXCR4 Antibody
|
Breast cancer
Glioblastoma Colon cancer Melanoma |
Pre-clinical
Pre-clinical Pre-clinical Pre-clinical |
(1) | Pre-clinical means that a product candidate is undergoing efficacy and safety evaluation in disease models in preparation for human clinical trials. Phase I-III clinical trials denote safety and efficacy tests in humans as follows: |
Phase I: Evaluation of safety and dosing. | |
Phase II: Evaluation of safety and efficacy. | |
Phase III: Larger scale evaluation of safety and efficacy. |
| Collection. A sample of a patients white blood cells is collected in a single and simple outpatient procedure called leukapheresis. | |
| Isolation of Precursors. These cells are sent to our manufacturing facility, where dendritic cell precursors are isolated from the patients white blood cells. | |
| Transformation by Growth Factors. Dendritic cell precursors are transformed in a manner that mimics the natural process in a healthy persons body, through the application of specific growth factors, into highly pure populations of immature dendritic cells during a six-day culture period. | |
| Maturation. Immature dendritic cells are exposed to a proprietary maturation factor or maturation method in order to maximize Helper T cell, Killer T cell, and B cell activation. | |
| Harvest for DCVax ® -Direct. These dendritic cells can be harvested for DCVax ® -Direct and separated into single-use DCVax ® administration vials, frozen and stored for the quality control sequence without the antigen display step. |
40
| Antigen Display. Cancer-associated antigens, fragments of cancer-associated antigens or deactivated whole cancer cells are added to, ingested, and processed by the maturing dendritic cells, causing the dendritic cells to display fragments of cancer-associated antigens on their outer cell surfaces. | |
| Harvest. These dendritic cells are harvested and separated into single-use DCVax ® administration vials, frozen and stored. | |
| Quality Control. Each DCVax ® product lot undergoes rigorous quality control testing, including 14-day sterility testing for bacterial and mycoplasma contamination, and potency testing prior to shipment to the administration site for injection. |
DCVax ® -Prostate |
41
DCVax ® -Brain |
42
DCVax ® -Lung |
DCVax ® -Direct |
DCVax ® -L |
| Identification. We identify, validate and select a potentially useful cancer-associated antigen for our therapeutic antibody platform. |
43
| Immunization. This cancer-associated antigen is used to immunize non-transgenic or transgenic mice. These mice create B cells, which produce non-human or fully human cancer-associated antigen-specific antibodies. | |
| Selection And Culturing. From the B cells created during immunization, we select single antibody-producing cells, which we then culture to large quantities. These cells produce identical antibodies with high specificity to the targeted cancer-associated antigen. | |
| Analysis And Evaluation. These non-human or fully human monoclonal antibodies are analyzed for specificity to the cancer-associated antigen, ability to bind to live cancer cells with high affinity and ability to kill those cells. In addition, the antibody-producing cells are evaluated for their ability to generate high quantities of the selected antibodies. | |
| Humanization. The non-human antibody with the most favorable properties can then be humanized, or stripped of its mouse characteristics. | |
| Manufacturing. Our therapeutic humanized or fully human monoclonal antibodies are then manufactured for clinical trials under FDA guidelines. |
Manufacturing |
Marketing |
Intellectual Property |
44
Competition |
| biopharmaceutical companies; | |
| biotechnology companies; | |
| pharmaceutical companies; | |
| academic institutions; and | |
| other research organizations. |
45
| secure the necessary funding to continue our development efforts with respect to our product candidates; | |
| successfully complete clinical trials and obtain all requisite regulatory approvals; | |
| maintain a proprietary position in our technologies and products; | |
| attract and retain key personnel; and | |
| maintain existing or enter into new partnerships. |
Governmental Regulation |
46
Employees |
47
48
Name | Age | Position | ||||
Alton L. Boynton, Ph.D.
|
61 | President, Chief Scientific Officer, Chief Operating Officer, Secretary and Director | ||||
Marnix L. Bosch, Ph.D.
|
47 | Vice President of Vaccine Research and Development |
49
Annual | |||||||||||||||||||||
Compensation | Long-Term | ||||||||||||||||||||
Fiscal | Compensation | All Other | |||||||||||||||||||
Name and Principal Position | Year | Salary | Bonus | Option Grants | Compensation(1) | ||||||||||||||||
Alton L. Boynton, Ph.D.
|
2005 | $ | 331,261 | | | $ | 17,814 | ||||||||||||||
President, Chief Operating Officer, | 2004 | $ | 332,534 | | | $ | 19,977 | ||||||||||||||
Chief Scientific Officer and Secretary | 2003 | $ | 288,967 | | 100,000 | $ | 294,909 | (2) | |||||||||||||
Marnix L. Bosch, Ph.D.
|
2005 | $ | 169,603 | | | $ | 18,396 | ||||||||||||||
Vice President of Vaccine Research | 2004 | $ | 169,602 | | | $ | 18,396 | ||||||||||||||
and Development | 2003 | $ | 159,710 | | 130,000 | $ | 32,872 | (3) | |||||||||||||
Paul M. Zeltzer, M.D.
|
2005 | $ | 77,543 | | | $ | 15,973 | (4) | |||||||||||||
Former Medical Director | 2004 | | | | | ||||||||||||||||
2003 | | | | | |||||||||||||||||
Larry L. Richards
|
2005 | $ | 121,909 | | | $ | 15,068 | ||||||||||||||
Former Controller(5) | 2004 | $ | 121,116 | | | $ | 14,815 | ||||||||||||||
2003 | $ | 119,572 | | 110,000 | $ | 26,331 | (6) |
(1) | All Other Compensation for each of the years in the three-year period ended December 31, 2005 consists of Company paid premiums on term life insurance coverage up to 1.5 times the employees annual salary, earned but unpaid accrued vacation payments, matching contribution on 401(k) up to a maximum of $3,000, and employer paid medical benefits. |
(2) | Includes $281,572 in exchange for terminating the severance provision in Dr. Boyntons employment agreement. The after tax portion of the severance of $183,000 was invested in our November 13, 2003 Secured Convertible Note and Warrants financing. |
(3) | Includes $19,570 in exchange for terminating the severance provision in Dr. Boschs employment arrangement. The after tax portion of the severance of $16,000 was invested in our November 13, 2003 Secured Convertible Note and Warrants financing. |
(4) | Dr. Zeltzer was hired on August 1, 2005 and his employment was terminated effective April 28, 2006. His annual salary was $200,000 on a full-time basis. |
(5) | We accepted Mr. Richards resignation on March 9, 2006. |
(6) | Includes $14,066 in exchange for terminating the severance provision in Mr. Richards employment arrangement. |
50
Number of Securities | ||||||||||||||||||||||||
Underlying Unexercised | Value of Unexercised In- | |||||||||||||||||||||||
Options at | The-Money Options at | |||||||||||||||||||||||
Shares | Fiscal Year End | Fiscal Year End(a) | ||||||||||||||||||||||
Acquired on | Value | |||||||||||||||||||||||
Name | Exercise | Realized | Exercisable | Unexercisable | Exercisable | Unexercisable | ||||||||||||||||||
Alton L. Boynton, Ph.D.
|
| | 338,955 | 5,555 | $ | 944 | $ | 56 | ||||||||||||||||
Marnix L. Bosch, Ph.D.
|
| | 112,654 | 54,846 | $ | 354 | $ | 146 | ||||||||||||||||
Paul M. Zeltzer, M.D.
|
| | | | | | ||||||||||||||||||
Larry L. Richards
|
| | 81,143 | 48,857 | $ | 212 | $ | 88 |
(a) | The market value of our common stock at December 31, 2005 was $0.10. |
Number of Securities | Number of Securities | |||||||||||
to be Issued | Weighted-Average | Remaining Available | ||||||||||
Upon Exercise of | Exercise Price of | for Future Issuance | ||||||||||
Outstanding Options | Outstanding Options | Under Equity | ||||||||||
Plan Category | and Other Rights | and Other Rights | Compensation Plans | |||||||||
Equity compensation plans approved by our stockholders(a)
|
743,111 | $ | 0.60 | 3,959,579 | ||||||||
Equity compensation plans not approved by our stockholders
|
| | | |||||||||
Total
|
743,111 | $ | 0.60 | 3,959,579 |
(a) | These plans consist of our 1998 Stock Option Plan, the 1999 Executive Stock Option Plan, the 2001 Stock Option Plan, the Employee Stock Purchase Plan and the 2001 Nonemployee Director Stock Incentive Plan. |
51
52
53
Original | Shares | Original | ||||||||||||||||||||||
Principal | Conversion | Original | Underlying | Exercise | ||||||||||||||||||||
Lender | Amount | Price/Share | Interest Rate | Maturity | Warrants | Price | ||||||||||||||||||
Alton Boynton
|
$ | 183,000 | $ | 0.18 | Prime + 2 | % | 11/12/2004 | 2,033,333 | $ | 0.18 | ||||||||||||||
Eric Holmes
|
$ | 50,000 | $ | 0.18 | Prime + 2 | % | 11/12/2004 | 555,555 | $ | 0.18 | ||||||||||||||
Dan Wilds
|
$ | 50,000 | $ | 0.18 | Prime + 2 | % | 11/12/2004 | 555,555 | $ | 0.18 | ||||||||||||||
Marnix Bosch
|
$ | 41,000 | $ | 0.18 | Prime + 2 | % | 11/12/2004 | 455,555 | $ | 0.18 | ||||||||||||||
Larry Richards
|
$ | 11,000 | $ | 0.18 | Prime + 2 | % | 11/12/2004 | 122,222 | $ | 0.18 | ||||||||||||||
Total
|
$ | 335,000 | 3,722,220 | |||||||||||||||||||||
54
| the issuance of a series of convertible promissory notes to Toucan Capital, a venture capital fund, in aggregate principal amount of approximately $6.75 million (and associated warrants) from February 2004 through September 2005. The first $1.1 million of the $6.75 million carried 300% warrant coverage and thereafter the notes carried 100% warrant coverage. The notes accrued interest at 10% per annum from the respective original issuance dates of the notes; | |
| the issuance of a convertible promissory note to Toucan Partners, an affiliate of Toucan Capital, in principal amount of $400,000 (and an associated warrant) in November 2005. This note accrues interest at 10% per annum from its original issuance dates. This note carried warrant coverage of 100%; | |
| the issuance of a series of non-convertible promissory notes to Toucan Partners, in an aggregate principal amount of approximately $550,000 from December 2005 through March 2006. These notes accrue interest at 10% per annum from the respective original issuance dates of the notes; | |
| the sale of Series A Preferred Stock to Toucan Capital for aggregate gross proceeds of approximately $1.3 million (and an associated warrant to purchase an aggregate of 13 million shares of Series A Preferred Stock at an exercise price of $0.04 per share) in January 2005; and | |
| the sale of approximately 39.5 million shares of common stock (and accompanying warrants to purchase an aggregate of approximately 19.7 million shares of common stock at an exercise price of $0.14 per share) to certain accredited investors for aggregate proceeds of approximately $5.5 million in April 2006 in our PIPE Financing. |
| an aggregate of 32.5 million shares of Series A Preferred Stock (convertible into an aggregate of 32.5 million shares of common stock); |
55
| an aggregate of approximately 4.8 million shares of Series A-1 Preferred Stock (convertible into an aggregate of approximately 192.7 million shares of common stock); | |
| warrants to purchase an aggregate of 66 million shares of capital stock at an exercise price of $0.01 per share; | |
| warrants to purchase an aggregate of 56.5 million shares of capital stock at an exercise price of $0.04 per share; and | |
| warrants to purchase an aggregate of 13 million shares of Series A Preferred Stock at an exercise price of $0.04 per share. |
| convertible promissory notes in aggregate principal amount of $950,000, with accrued interest thereon of approximately $48,000 as of July 6, 2006 (with such notes convertible as of July 6, 2006 into an aggregate of approximately 25.0 million shares of capital stock at a conversion price of $0.04 per share); and | |
| warrants to purchase an aggregate of 9.5 million shares of capital stock at an exercise price of $0.04 per share. |
56
| each person, or group of affiliated persons, who is known by us to own beneficially 5% or more of our common stock; | |
| our current director; | |
| each of our named executive officers; | |
| our current director and all of our executive officers as a group; and | |
| in the second table, each selling stockholder. |
57
Shares of Common Stock | |||||||||
Beneficially Owned(1) | |||||||||
Beneficial Owner | Number | Percentage | |||||||
Officers and Directors
|
|||||||||
Alton L. Boynton, Ph.D.(2)
|
4,646,800 | 6.7 | % | ||||||
Marnix L. Bosch, Ph.D.(3)
|
1,116,023 | 1.7 | % | ||||||
Paul Zeltzer, M.D.
|
| * | |||||||
Larry Richards(4)
|
175,832 | * | |||||||
All executive officers and directors as a group(3 persons)(5)
|
5,762,823 | 8.1 | % | ||||||
5% Security Holders
|
|||||||||
Entities associated with Toucan Capital Fund II, L.P.(6)
|
395,136,789 | 85.8 | % | ||||||
C.E. Unterberg Towbin Capital Partners I LP(7)
|
5,362,500 | 8.0 | % | ||||||
Iroquois Masterfund Ltd(8)
|
5,357,143 | 8.0 | % | ||||||
Southridge Partners LP(9)
|
4,553,571 | 6.8 | % | ||||||
Northwood Capital Partners, LP(10)
|
3,750,000 | 5.6 | % | ||||||
Medarex, Inc.(11)
|
3,600,000 | 5.2 | % |
* | less than 1% |
(1) | Percentage represents beneficial ownership percentage of common stock calculated in accordance with SEC rules and does not equate to voting percentages. Because the Series A Preferred Stock and Series A-1 Preferred Stock vote together with the common stock on substantially all matters, actual voting percentage represented by the shares of common stock beneficially owned by certain stockholders is lower than the percentages reflected in the table (as noted in footnotes 2, 3, 4, 5, 7, 8, 9, 10 and 11 below). | |
(2) | Includes 4,302,290 shares of common stock held by Dr. Boynton and 344,510 shares of common stock issuable upon exercise of options that are exercisable within 60 days of July 6, 2006. Represents voting percentage of approximately 1.5%. | |
(3) | Includes 981,442 shares of common stock held by Dr. Bosch and 134,581 shares of common stock issuable upon exercise of options that are exercisable within 60 days of July 6, 2006. Represents voting percentage of less than 1%. | |
(4) | Includes 175,832 shares of common stock held. Represents voting percentage of less than 1%. | |
(5) | Includes 5,283,732 shares of common stock held by the officers and directors and 479,091 shares issuable upon exercise of options that are exercisable within 60 days of July 6, 2006. Represents voting percentage of approximately 1.8%. | |
(6) | Includes (i) 225,174,520 shares of common stock issuable upon conversion of preferred stock held by Toucan Capital; (ii) 135,500,000 shares of common stock currently issuable upon exercise of warrants held by Toucan Capital; (iii) 24,962,269 shares of common stock issuable upon conversion of promissory notes held by Toucan Partners; and (iv) 9,500,000 shares issuable upon exercise of warrants held by Toucan Partners. | |
(7) | Includes 1,787,500 shares of common stock currently issuable upon exercise of warrants. Represents voting percentage of approximately 1.8%. |
58
(8) | Includes 1,785,714 shares of common stock currently issuable upon exercise of warrants. Represents voting percentage of approximately 1.8%. | |
(9) | Includes 1,517,857 shares of common stock currently issuable upon exercise of warrants. Represents voting percentage of approximately 1.6%. |
(10) | Includes 1,250,000 shares of common stock currently issuable upon exercise of warrants. Represents voting percentage of approximately 1.3%. |
(11) | Includes 800,000 shares of common stock currently issuable upon exercise of warrants. Based on a Form 3 and Schedule 13G filed by Medarex with the SEC. Represents voting percentage of approximately 1.2%. |
Shares of Common Stock | Shares of Common Stock | |||||||||||||||||||
Beneficially Owned | Beneficially Owned | |||||||||||||||||||
Before the Offering(1) | Shares | After the Offering(3) | ||||||||||||||||||
Being | ||||||||||||||||||||
Beneficial Owner | Number | Percentage | Offered(2) | Number | Percentage | |||||||||||||||
Bluegrass Growth Fund, L.P.(4)
|
2,678,571 | 4.1 | % | 2,678,571 | 0 | * | ||||||||||||||
Andrew M. Blum(5)
|
53,625 | * | 53,625 | 0 | * | |||||||||||||||
Bristol Investment Fund, Ltd(6)
|
1,607,143 | 2.4 | % | 1,607,143 | 0 | * | ||||||||||||||
C.E. Unterberg Towbin Capital Partners I LP(7)
|
5,362,500 | 8.0 | % | 5,362,500 | 0 | * | ||||||||||||||
Jason L. DiPaola(8)
|
214,500 | * | 214,500 | 0 | * | |||||||||||||||
Cranshire Capital, LP(9)
|
2,678,571 | 4.1 | % | 2,678,571 | 0 | * | ||||||||||||||
Ellis International Limited(10)
|
2,678,571 | 4.1 | % | 2,678,571 | 0 | * | ||||||||||||||
Jeffrey M. Gallups(11)
|
300,000 | * | 300,000 | 0 | * | |||||||||||||||
John H. Gutfreund(12)
|
536,250 | * | 536,250 | 0 | * | |||||||||||||||
Smithfield Fiduciary LLC(13)
|
2,678,571 | 4.1 | % | 2,678,571 | 0 | * | ||||||||||||||
Iroquois Masterfund Ltd(14)
|
5,357,143 | 8.0 | % | 5,357,143 | 0 | * | ||||||||||||||
Comtech Global Investment Ltd(15)
|
1,500,000 | 2.3 | % | 1,500,000 | 0 | * | ||||||||||||||
Alpha Capital AG(16)
|
1,607,142 | 2.4 | % | 1,607,142 | 0 | * | ||||||||||||||
Little Gem Life Sciences Fund LLC(17)
|
1,071,429 | 1.6 | % | 1,071,429 | 0 | * | ||||||||||||||
Monarch Capital Fund Ltd
|
1,910,662 | 2.9 | % | 1,910,662 | 0 | * | ||||||||||||||
Hope Ni(18)
|
300,000 | * | 300,000 | 0 | * | |||||||||||||||
Nite Capital LP(19)
|
2,678,571 | 4.1 | % | 2,678,571 | 0 | * | ||||||||||||||
Northwood Capital Partners, LP(20)
|
3,750,000 | 5.6 | % | 3,750,000 | 0 | * | ||||||||||||||
Cabernet Partners, LP(21)
|
1,500,000 | 2.3 | % | 1,500,000 | 0 | * | ||||||||||||||
Chardonnay Partners, LP(22)
|
900,000 | 1.4 | % | 900,000 | 0 | * | ||||||||||||||
Robert A. Berlacher(23)
|
600,000 | * | 600,000 | 0 | * | |||||||||||||||
Insignia Partners, LP(24)
|
2,250,000 | 3.4 | % | 2,250,000 | 0 | * | ||||||||||||||
Joseph Reda(25)
|
375,000 | * | 375,000 | 0 | * | |||||||||||||||
Southridge Partners LP(26)
|
4,553,571 | 6.8 | % | 4,553,571 | 0 | * | ||||||||||||||
Southshore Capital Fund Ltd(27)
|
803,571 | 1.2 | % | 803,571 | 0 | * | ||||||||||||||
Stoc*Doc Partners, L.P.(28)
|
300,000 | * | 300,000 | 0 | * | |||||||||||||||
Ellen U Celli Emily U Satloff TTEE T.I. Unterberg(29)
|
536,250 | * | 536,250 | 0 | * | |||||||||||||||
Declaration of Trust by Thomas I. Unterberg(30)
|
1,072,500 | 1.6 | % | 1,072,500 | 0 | * | ||||||||||||||
Thomas I. Unterberg(31)
|
2,145,000 | 3.3 | % | 2,145,000 | 0 | * | ||||||||||||||
Thomas I. Unterberg TTEE Ellen U. Celli Family Trust /25/93(32)
|
1,072,500 | 1.6 | % | 1,072,500 | 0 | * |
59
Shares of Common Stock
Shares of Common Stock
Beneficially Owned
Beneficially Owned
Before the Offering(1)
Shares
After the Offering(3)
Being
Beneficial Owner
Number
Percentage
Offered(2)
Number
Percentage
1,072,500
1.6
%
1,072,500
0
*
536,250
*
536,250
0
*
1,608,000
2.4
%
1,608,000
0
*
1,072,500
1.6
%
1,072,500
0
*
1,072,500
1.6
%
1,072,500
0
*
536,250
*
536,250
0
*
* | Less than 1% |
(1) | Calculated based on Rule 13d-3(d)(i). In calculating this amount for each selling stockholder, we treated as outstanding the number of shares of common stock issuable upon exercise for cash of that selling stockholders warrants but we did not assume exercise of any other selling stockholders warrants. | |
(2) | In calculating this amount for each selling stockholder, we included the number of shares of common stock issuable upon exercise for cash of that selling stockholders warrants. | |
(3) | Assumes sale of all shares offered by the selling stockholder. | |
(4) | Includes 892,857 shares of common stock currently issuable upon exercise of warrant. | |
(5) | Includes 17,875 shares of common stock currently issuable upon exercise of warrant. | |
(6) | Includes 535,714 shares of common stock currently issuable upon exercise of warrant. | |
(7) | Includes 1,787,500 shares of common stock currently issuable upon exercise of warrant. | |
(8) | Includes 71,500 shares of common stock currently issuable upon exercise of warrant. | |
(9) | Includes 892,857 shares of common stock currently issuable upon exercise of warrant. | |
(10) | Includes 892,857 shares of common stock currently issuable upon exercise of warrant. |
(11) | Includes 100,000 shares of common stock currently issuable upon exercise of warrant. |
(12) | Includes 178,750 shares of common stock currently issuable upon exercise of warrant. |
(13) | Includes 892,857 shares of common stock currently issuable upon exercise of warrant. |
(14) | Includes 1,785,714 shares of common stock currently issuable upon exercise of warrant. |
(15) | Includes 500,000 shares of common stock currently issuable upon exercise of warrant. |
(16) | Includes 535,714 shares of common stock currently issuable upon exercise of warrant. |
(17) | Includes 357,143 shares of common stock currently issuable upon exercise of warrant. |
(18) | Includes 100,000 shares of common stock currently issuable upon exercise of warrant. |
(19) | Includes 892,857 shares of common stock currently issuable upon exercise of warrant. |
(20) | Includes 1,250,000 shares of common stock currently issuable upon exercise of warrant. |
(21) | Includes 500,000 shares of common stock currently issuable upon exercise of warrant. |
(22) | Includes 300,000 shares of common stock currently issuable upon exercise of warrant. |
(23) | Includes 200,000 shares of common stock currently issuable upon exercise of warrant. |
(24) | Includes 750,000 shares of common stock currently issuable upon exercise of warrant. |
(25) | Includes 125,000 shares of common stock currently issuable upon exercise of warrant. |
(26) | Includes 1,517,857 shares of common stock currently issuable upon exercise of warrant. |
60
(27) | Includes 267,857 shares of common stock currently issuable upon exercise of warrant. |
(28) | Includes 100,000 shares of common stock currently issuable upon exercise of warrant. |
(29) | Includes 178,750 shares of common stock currently issuable upon exercise of warrant. |
(30) | Includes 357,500 shares of common stock currently issuable upon exercise of warrant. |
(31) | Includes 715,000 shares of common stock currently issuable upon exercise of warrant. |
(32) | Includes 357,500 shares of common stock currently issuable upon exercise of warrant. |
(33) | Includes 357,500 shares of common stock currently issuable upon exercise of warrant. |
(34) | Includes 178,750 shares of common stock currently issuable upon exercise of warrant. |
(35) | Includes 536,000 shares of common stock currently issuable upon exercise of warrant. |
(36) | Includes 357,500 shares of common stock currently issuable upon exercise of warrant. |
(37) | Includes 357,500 shares of common stock currently issuable upon exercise of warrant. |
(38) | Includes 178,750 shares of common stock currently issuable upon exercise of warrant. |
61
| 185,394,540 shares of common stock for issuance upon exercise of outstanding warrants, | |
| 24,962,269 shares of common stock for issuance upon conversion of our convertible promissory notes, | |
| 32,500,000 shares of common stock for issuance upon conversion of our Series A Stock, | |
| 192,267,520 shares of common stock for issuance upon conversion of our Series A-1 Stock, | |
| 383,246 shares of common stock for issuance under our 1998 Stock Option Plan, | |
| 586,166 shares of common stock for issuance under our 1999 Executive Stock Option Plan, | |
| 2,906,551 shares of common stock for issuance under our 2001 Stock Option Plan, | |
| 182,500 shares of common stock for issuance under our 2001 Nonemployee Director Stock Incentive Plan, | |
| 158,600 shares of common stock for issuance under our Employment Agreement Plan, and | |
| 485,626 shares of common stock for issuance under our Employee Stock Purchase Plan. |
62
(i) is entitled to cumulative dividends at the rate of 10% per year; | |
(ii) is entitled to a liquidation preference in the amount of its initial purchase price plus all accrued and unpaid dividends (to the extent of legally available funds); | |
(iii) has a preference over the common stock, and is on a pari passu basis with the Series A-1 Stock, with respect to dividends and distributions; | |
(iv) is entitled to participate on an as-converted basis with the common stock on any distributions after the payment of any preferential amounts to the Series A Stock and the Series A-1 Stock; | |
(v) votes on an as converted basis with the common stock and the Series A-1 Stock on matters submitted to the common stockholders for approval and as a separate class on certain other material matters; and | |
(vi) is convertible into common stock on a one-for-one basis (subject to adjustment in the event of stock dividends, stock splits, reverse stock splits, recapitalizations, etc.). |
Demand Registration Rights. The holders of 20% or more of the registrable securities, or their transferees, may require us on not more than two occasions in a twelve month period (exclusive of registration on Form S-3), to file a registration statement under the Securities Act with respect to their shares of common stock, provided that the anticipated aggregate offering price to the public of at least $2.0 million. These registration rights are subject to specified conditions and limitations. Under the terms of the registration pursuant to which these rights are granted, we will be required to register for resale these shares if we receive a written request from holders of at least a majority of all such shares then outstanding. | |
Piggyback Registration Rights. If we propose to register any of our securities under the Securities Act either for our own account or for the account of other stockholders, the holders of the |
63
registrable securities will be entitled to notice of the registration and will be entitled to include their shares of common stock in the registration statement. These registration rights are subject to specified conditions and limitations, including the right of the underwriters to limit the number of shares included in any such registration under some circumstances and the right of the holders to include their shares in the registration statement before we can include shares that we propose to sell. The holders of these shares have waived their right to have their shares included in this offering. | |
Registration on Form S-3. The holders of the registrable securities are entitled, upon written request from holders of registrable securities, to have such shares registered by us on a Form S-3 registration statement at our expense provided that such requested registration has an anticipated aggregate offering price to the public of at least $1.0 million. These registration rights are subject to specified conditions and limitations. | |
Expenses of Registration. We will pay all expenses relating to any demand, piggyback or Form S-3 registrations, other than underwriting discounts and commissions. | |
Expiration of Registration Rights. The rights granted to a holder under the investor rights agreement will terminate upon (A) any consolidation or merger of Northwest Biotherapeutics with or into any other corporation or other entity or person, or any other corporate reorganization, other than any such consolidation, merger or reorganization in which our stockholders immediately prior to such consolidation, merger or reorganization, continue to hold at least a majority of the voting power of the surviving entity in substantially the same proportions (or, if the surviving entity is a wholly owned subsidiary, its parent) immediately after such consolidation, merger or reorganization; or (B) any transaction or series of related transactions to which we are a party in which in excess of fifty percent (50%) of our voting power is transferred. |
64
| prior to such time our board of directors approved either the business combination or the transaction which resulted in the stockholder becoming an interested stockholder; | |
| upon consummation of the transaction which resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of our voting stock outstanding at the time the transaction commenced, excluding for purposes of determining the voting stock outstanding (but not the outstanding voting stock owned by the interested stockholder) those shares owned (i) by persons who are directors and also officers and (ii) employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or | |
| at or subsequent to such time the business combination is approved by the board of directors and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2 / 3 % of the outstanding voting stock which is not owned by the interested stockholder. |
| any sale, transfer, pledge or other disposition of 10% or more of the assets of the corporation involving the interested stockholder; | |
| subject to some exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder; |
65
| any transaction involving the corporation that has the effect of increasing the proportionate share of the stock of any class or series of the corporation beneficially owned by the interested stockholder; or | |
| the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation. |
| 1% of the number of shares of our common stock then outstanding, which equals approximately 652,000 shares based on the number of shares of common stock outstanding as of July 6, 2006; or | |
| the average weekly trading volume of our common stock on the Over-The-Counter Bulletin Board during the four calendar weeks preceding the filing of a notice on Form 144 with respect to the sale. |
66
67
| ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; | |
| block trades in which the broker-dealer will attempt to sell the shares as agent, but may position and resell a portion of the block as principal to facilitate the transaction; | |
| purchases by a broker-dealer as principal and resale by the broker-dealer for its account; | |
| an exchange distribution in accordance with the rules of the applicable exchange; | |
| privately negotiated transactions; | |
| short sales effected after the date the registration statement of which this prospectus is a part is declared effective by the SEC; | |
| through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; | |
| broker-dealers may agree with the selling stockholders to sell a specified number of such shares at a stipulated price per share; | |
| a combination of any such methods of sale; and | |
| any other method permitted pursuant to applicable law. |
68
69
70
Page | |||||
I FINANCIAL INFORMATION
|
|||||
Financial Statements (unaudited)
|
|||||
F-2 | |||||
F-3 | |||||
F-4 | |||||
F-5 | |||||
II FINANCIAL STATEMENTS
|
|||||
F-14 | |||||
F-15 | |||||
F-16 | |||||
F-17 | |||||
F-18 | |||||
F-22 | |||||
F-24 |
F-1
F-2
F-3
F-4
F-5
F-6
F-7
Table of Contents
Three Months Ended
Period from
March 31,
March 18, 1996
(Inception) to
2005
2006
March 31, 2006
(Unaudited)
(In thousands, except per share data)
$
11
$
$
450
1,128
76
1,061
87
2,639
2
382
1,315
427
32,494
464
427
31,121
24
10
2,276
895
2,066
1,805
864
69,234
(1,718
)
(864
)
(66,595
)
(2,113
)
(2,481
)
3,656
(809
)
(982
)
(14,119
)
1
1
737
(2,526
)
(3,958
)
(78,802
)
(1,872
)
(1,700
)
(4,274
)
$
(2,526
)
$
(3,958
)
$
(86,648
)
$
(0.13
)
$
(0.21
)
19,035
19,230
Table of Contents
Three Months
Period from
Ended March 31,
March 18, 1996
(Inception) to
2005
2006
March 31, 2006
(Unaudited)
(In thousands)
$
(2,526
)
$
(3,958
)
$
(78,802
)
24
10
2,276
320
695
771
11,029
260
112
201
998
4
2
1,095
(3,656
)
(81
)
(16
)
267
2,113
2,481
2,066
895
(86
)
17
(58
)
63
31
380
341
220
5,373
(265
)
(35
)
410
(1,489
)
(609
)
(54,931
)
(4,580
)
81
16
249
1,816
2,000
(3
)
(1,035
)
81
16
(1,553
)
1,650
(1,650
)
300
13,099
2,834
(2,834
)
(55
)
(13
)
(119
)
(11
)
(5
)
(316
)
(420
)
1,276
28,708
2
220
17,373
2,900
2,900
(1,700
)
(320
)
1,212
3,182
59,425
(196
)
2,589
2,941
248
352
$
52
$
2,941
$
2,941
$
2
$
2
$
1,398
285
6,719
12,037
1,872
64
6,906
5,324
43
4
840
35
4
759
849
480
491
Table of Contents
1.
Basis of Presentation
2.
Summary of significant accounting policies
Stock-based Compensation
3.
Stock-Based Compensation Plans
Table of Contents
Determining Fair Value Under SFAS 123(R)
Pro Forma Information Under SFAS 123 and
APB 25
Table of Contents
Three Months
Ended March 31,
2005
$
(2,526
)
4
(24
)
$
(2,546
)
$
(0.13
)
$
(0.13
)
4.
Liquidity
Table of Contents
5.
Net Loss Per Share Applicable to Common Stockholders
6.
Notes Payable
Management Loans |
F-8
Toucan Capital Loans |
F-9
Toucan Partners Loans
Interest
Conversion
Warrant
Loan Date
Principal(1)
Due Date
Rate(2)
Shares(3)
Shares(3)
(In thousands)
(In thousands)
(In thousands)
$
400
11/14/2006
10
%
10,391
4,000
(4)
250
12/30/2006
10
%
6,402
2,500
(5)
300
03/09/2007
10
%
7,545
3,000
(5)
$
950
24,338
9,500
(1) | The notes are secured by a first priority senior security interest in all of the Companys assets. |
(2) | Interest accrues at 10% per annum, based on a 365-day basis compounded annually from the respective original issuance dates of the notes. |
(3) | The notes are convertible into, and the warrants are exercisable for, shares of convertible preferred stock if the convertible preferred stock is approved and authorized and other investors have purchased in cash a minimum of $15 million of such convertible preferred stock, on the terms and conditions set forth in the recapitalization agreement. However, if, for any reason, such convertible preferred stock is not approved or authorized and/or if other investors have not purchased in cash a minimum of $15 million of such convertible preferred stock, on the terms and conditions set forth in the recapitalization agreement, these notes shall be convertible into, and the warrants shall be exercisable for, any equity security and/or debt security and/or any combination thereof. |
(4) | Exercise period is 7 years from the issuance date of the note. |
(5) | Exercise period is 7 years from April 17, 2006 (the issuance date of the warrant). |
7. | Liability for Potentially Dilutive Securities in Excess of Authorized Number of Common Shares |
F-10
8. | Private Placement |
F-11
9. | Contingency |
Sales Tax Assessment |
F-12
10. | Commitments |
11. | Recent Accounting Pronouncements |
F-13
F-14
F-15
F-16
F-17
F-18
F-19
F-20
F-21
F-22
F-23
F-24
F-25
F-26
F-27
F-28
F-29
F-30
F-31
F-32
F-33
F-34
F-35
F-36
F-37
F-38
F-39
F-40
F-41
F-42
F-43
F-44
F-45
F-46
Table of Contents
Period from
March 18, 1996
Years Ended December 31,
(Inception) to
December 31,
2003
2004
2005
2005
(In thousands except per share
data)
$
24
$
52
$
38
$
450
1,128
505
338
86
1,061
529
390
124
2,639
79
40
12
382
1,624
3,621
4,469
32,067
4,059
2,845
2,005
30,694
207
132
63
2,266
174
895
904
130
2,066
7,047
6,768
6,549
68,370
(6,518
)
(6,378
)
(6,425
)
(65,731
)
(368
)
(368
)
816
3,656
(73
)
(1,765
)
(3,517
)
(13,137
)
23
3
5
736
(5,752
)
(8,508
)
(9,937
)
(74,844
)
(1,872
)
(1,700
)
(4,274
)
$
(5,752
)
$
(8,508
)
$
(9,937
)
$
(82,690
)
$
(0.30
)
$
(0.45
)
$
(0.52
)
18,908
19,028
19,068
Table of Contents
Deficit
Accumulated
Common Stock
Preferred Stock
Additional
During the
Total
Paid-In
Deferred
Development
Stockholders
Shares
Amount
Shares
Amount
Capital
Compensation
Stage
Equity (Deficit)
(In thousands)
$
$
$
$
$
(106
)
(106
)
(1,233
)
(1,233
)
(1,339
)
(1,339
)
(275
)
(275
)
(2,560
)
(2,560
)
(4,174
)
(4,174
)
2,203
2
(2
)
(329
)
(329
)
(4,719
)
(4,719
)
2,203
2
(9,224
)
(9,222
)
394
394
(354
)
(354
)
(5,609
)
(5,609
)
2,203
2
394
(15,187
)
(14,791
)
43
43
2
1
1
5
4
4
4,039
4,039
1,026
1,026
368
368
3
3
(275
)
Table of Contents
Deficit
Accumulated
Common Stock
Preferred Stock
Additional
During the
Total
Paid-In
Deferred
Development
Stockholders
Shares
Amount
Shares
Amount
Capital
Compensation
Stage
Equity (Deficit)
(In thousands)
(430
)
(430
)
(12,779
)
(12,779
)
1,935
2
5,878
(28,396
)
(22,516
)
225
225
456
456
4,274
(4,274
)
2,287
2,287
1,158
1
407
408
4,000
4
17,151
17,155
9,776
10
31,569
31,579
(1,700
)
(1,700
)
45
45
1,330
(1,330
)
314
314
(379
)
(379
)
(10,940
)
(10,940
)
16,869
17
63,622
(1,016
)
(45,689
)
16,934
1,000
1
199
200
9
6
6
80
80
8
34
34
Table of Contents
Deficit
Accumulated
Common Stock
Preferred Stock
Additional
During the
Total
Paid-In
Deferred
Development
Stockholders
Shares
Amount
Shares
Amount
Capital
Compensation
Stage
Equity (Deficit)
(In thousands)
57
57
22
(22
)
(301
)
301
32
18
18
99
449
(449
)
(87
)
(392
)
392
350
350
(12,804
)
(12,804
)
17,930
18
63,794
(444
)
(58,493
)
4,875
1,000
1
199
200
90
35
35
80
80
221
221
114
114
4
8
(4
)
(20
)
20
(131
)
131
240
240
2
2
(5,752
)
(5,752
)
19,028
$
19
$
64,294
$
(53
)
$
(64,245
)
$
15
1,711
1,711
1,156
1,156
1
Table of Contents
Deficit
Accumulated
Common Stock
Preferred Stock
Additional
During the
Total
Paid-In
Deferred
Development
Stockholders
Shares
Amount
Shares
Amount
Capital
Compensation
Stage
Equity (Deficit)
(In thousands)
(5
)
5
41
41
368
368
(8,508
)
(8,508
)
19,029
$
19
$
67,524
$
(7
)
$
(72,753
)
$
(5,217
)
32,500
33
1,243
1,276
3
3
1,878
1,878
49
4
4
7
7
1,172
1,172
(604
)
(604
)
(9,937
)
(9,937
)
19,078
$
19
32,500
$
33
$
71,220
$
$
(82,690
)
$
(11,418
)
Table of Contents
Period from
March 18, 1996
Years Ended December 31,
(Inception) to
December 31,
2003
2004
2005
2005
(In thousands)
$
(5,752
)
$
(8,508
)
$
(9,937
)
$
(74,844
)
207
132
63
2,266
320
42
1,559
2,908
10,258
260
2
192
603
797
242
41
10
1,093
(7
)
41
516
(816
)
(3,656
)
(95
)
(41
)
(97
)
(233
)
368
368
904
130
2,066
174
895
(5
)
(3
)
(64
)
(75
)
660
(66
)
34
349
(84
)
1,809
2,289
5,153
(266
)
1
(265
)
35
(35
)
110
(66
)
410
(4,677
)
(4,425
)
(4,184
)
(54,322
)
(149
)
(43
)
(4,580
)
95
41
97
233
816
1,816
1,828
2,000
(45
)
45
(3
)
(3
)
75
(1
)
(1,035
)
2,545
161
50
(1,569
)
Table of Contents
Period from
March 18, 1996
Years Ended December 31,
(Inception) to
December 31,
2003
2004
2005
2005
(In thousands)
1,650
(1,650
)
335
4,350
3,050
12,799
(52
)
(54
)
(106
)
2,834
(2,834
)
(67
)
(41
)
(38
)
(311
)
(420
)
(420
)
1,276
28,708
220
4
17,373
(1,700
)
(320
)
(152
)
4,257
4,238
56,243
(2,284
)
(7
)
104
352
2,539
255
248
$
255
$
248
$
352
$
352
$
29
$
12
$
7
$
1,396
$
$
$
$
285
4,714
604
5,318
1,872
2,766
3,050
6,842
5,324
43
4
280
840
35
240
41
7
759
151
5
849
71
491
480
Table of Contents
(1)
Organization and Description of Business
(2)
Operations and Financing
Lender
Title
Principal
Director, President, Chief Scientific Officer, Chief Operating
Officer and Secretary
$
183,000
Vice President of Vaccine Research and Development
41,000
Former Controller
11,000
Total
$
235,000
Table of Contents
Toucan Capital Loans
Table of Contents
Accrued
Conversion
Warrant
Loan Date
Principal(1)
Due Date
Interest(2)
Shares(2)
Shares(3)(4)
(In thousands)
(In thousands)
(In thousands)
(In thousands)
$
50
06/01/06
(5)
$
10
1,500
3,000
(6)
50
06/01/06
(5)
10
1,490
3,000
(6)
500
06/01/06
(5)
87
14,688
30,000
(6)
500
06/01/06
(5)
81
14,515
30,000
(6)
2,000
06/01/06
(5)
293
57,319
20,000
(7)
500
06/01/06
(5)
61
14,014
5,000
(7)
500
06/01/06
(5)
58
13,942
5,000
(7)
250
06/01/06
(5)
25
6,882
2,500
(7)
450
06/01/06
(5)
32
11,965
4,500
(7)
450
06/01/06
(5)
29
11,932
4,500
(7)
500
06/16/06
27
13,041
5,000
(7)
500
07/26/06
21
12,893
5,000
(7)
500
09/07/06
16
12,629
5,000
(7)
$
6,750
$
750
186,810
122,500
(1)
The notes are secured by a first priority senior security
interest in all of the Companys assets.
(2)
Interest accrues at 10% per annum, based on a
365-day
basis
compounded annually from the respective original issuance dates
of the notes.
(3)
The notes are convertible into, and the warrants are exercisable
for, shares of convertible preferred stock if the convertible
preferred stock is approved and authorized and other investors
have purchased in cash a minimum of $15 million of such
convertible preferred stock, on the terms and conditions set
forth in the Recapitalization Agreement. However, if, for any
reason, such convertible preferred stock is not approved or
authorized and/or if other investors have not purchased in cash
a minimum of $15 million of such convertible preferred
stock, on the terms and conditions set forth in the
Recapitalization Agreement, these notes shall be convertible
into, and these warrants shall be exercisable for any equity
security and/or debt security and/or any combination thereof.
(4)
Exercise period is 7 years from the issuance date of the
convertible note except for the February 2, 2004 and
March 1, 2004 warrants, which have an April 26, 2011
expiration date.
(5)
As of March 9, 2006, the maturity dates were extended to
June 1, 2006.
(6)
Per share exercise price is $0.01.
(7)
Per share exercise price is $0.04.
Toucan Capital Loans and Related Beneficial Conversions,
Warrant Valuations, and Amortization
Table of Contents
2004
2005
1.61% - 3.87%
2.86% - 4.03%
7 years
7 years
218% - 239%
416% - 440%
0%
0%
Toucan Partners Loans, Beneficial Conversion, Warrant
Valuation, and Amortization
Interest
Conversion
Warrant
Loan Date
Principal(1)
Due Date
Rate(2)
Shares(3)
Shares(3)
(In thousands)
(In thousands)
(In thousands)
$
400
11/14/06
10
%
10,150
4,000
(4)
250
12/30/06
10
%
6,253
2,500
(5)
$
650
16,403
6,500
(1)
The notes are secured by a first priority senior security
interest in all of the Companys assets.
(2)
Interest accrues at 10% per annum, based on a
365-day
basis
compounded annually from the respective original issuance dates
of the notes.
Table of Contents
(3)
The notes are convertible into, and the warrants are exercisable
for, shares of convertible preferred stock if the convertible
preferred stock is approved and authorized and other investors
have purchased in cash a minimum of $15 million of such
convertible preferred stock, on the terms and conditions set
forth in the Recapitalization Agreement. However, if, for any
reason, such convertible preferred stock is not approved or
authorized and/or if other investors have not purchased in cash
a minimum of $15 million of such convertible preferred
stock, on the terms and conditions set forth in the
Recapitalization Agreement, these notes shall be convertible
into, and the warrants shall be exercisable for, any equity
security and/or debt security and/or any combination thereof.
(4)
Exercise period is 7 years from the issuance date of the
note.
(5)
Exercise period is 7 years from April 17, 2006 (the
issuance date of the warrant).
Toucan Capital Series A Cumulative Convertible
Preferred Stock
(i) is entitled to cumulative dividends at the rate of
10% per year;
(ii) is entitled to a liquidation preference in the amount
of its initial purchase price plus all accrued and unpaid
dividends (to the extent of legally available funds);
(iii) has a preference over the common stock, and is pari
passu with the Series A-1 Preferred Stock, with respect to
dividends and distributions;
Table of Contents
(iv) is entitled to participate on an as-converted basis
with the common stock on any distributions after the payment of
any preferential amounts to the Series A Preferred Stock
and the Series A-1 Preferred Stock;
(v) votes on an as converted basis with the common stock
and the Series A-1 Preferred Stock on matters submitted to the
common stockholders for approval and as a separate class on
certain other material matters; and
(vi) is convertible into common stock on a one-for-one
basis (subject to adjustment in the event of stock dividends,
stock splits, reverse stock splits, recapitalizations, etc.).
Liability For Potentially Dilutive Securities in Excess of
Authorized Number of Common Shares
Table of Contents
Liquidity
(3)
Summary of Significant Accounting Policies
(a)
Use of Estimates in Preparation of Financial
Statements
(b)
Cash
(c)
Fair Value of Financial Instruments and Concentrations of
Risk
Table of Contents
(d)
Property and Equipment
Shorter of life of the lease or useful life
5-7 years
3-5 years
(e)
Impairment of long-lived assets
(f)
Restricted Cash
(g)
Operating Leases
(h)
Revenue Recognition
Table of Contents
(i)
Research and Development Expenses
(j)
Income Taxes
(k)
Stock-Based Compensation
Table of Contents
Year Ended December 31,
2003
2004
2005
$
(5,752
)
$
(8,508
)
$
(9,937
)
240
41
7
(590
)
(47
)
(13
)
$
(6,102
)
$
(8,514
)
$
(9,943
)
$
(0.30
)
$
(0.45
)
$
(0.52
)
$
(0.32
)
$
(0.45
)
$
(0.52
)
2003
2005
2.97
%
3.53
%
5 years
5 years
200
%
403
%
0
%
0
%
(l)
Loss Per Share
(m)
Operating Segments
Operating costs:
Table of Contents
Research and development:
General and administrative:
(n)
Recent Accounting Pronouncements
Table of Contents
(4)
Stockholders Equity (Deficit)
(a)
Issuance of Unregistered Common Stock
Table of Contents
(b)
Issuance of Unregistered Preferred Stock
(i) is entitled to cumulative dividends at the rate of
10% per year;
(ii) is entitled to a liquidation preference in the amount of
its initial purchase price plus all accrued and unpaid dividends
(to the extent of legally available funds);
(iii) has a preference over the common stock, and is pari passu
with the Series A-1 Preferred Stock, with respect to
dividends and distributions;
(iv) is entitled to participate on an as-converted basis with
the common stock and the Series A-1 Preferred Stock on any
distributions after the payment of any preferential amounts to
the Series A Preferred Stock;
(v) votes on an as converted basis with the common stock and the
Series A-1 Preferred Stock on matters submitted to the
common stockholders for approval and as a separate class on
certain other material matters; and
(vi) is convertible into common stock on a one-for-one basis
(subject to adjustment in the event of stock dividends, stock
splits, reverse stock splits, recapitalizations, etc.).
(c)
Stock Purchase Warrants
Table of Contents
Management Loan Warrants
Toucan Capital and Toucan Partners Warrants
Table of Contents
Weighted-
Number
Average
Type of Warrant
Outstanding
Exercise Price
(In thousands)
810
$
0.24
142,000
$
0.03
235
$
2.50
324
$
5.00
3,722
$
0.04
(1)
The exercise of Series C and Series D Preferred Stock
warrants will result in the issuance of an equal number of
shares of the Companys common stock with no issuance of
preferred stock.
(d)
Stock Option Plans
(i)
1998 Stock Option Plan (1998 Plan)
The Companys 1998 Stock Option Plan (1998 Plan) has
reserved 413,026 shares of common stock for stock option
grants to employees, directors and consultants of the Company.
As of December 31, 2005, net of forfeitures, a total of
337,146 shares remain available for granting under this
plan.
(ii)
1999 Executive Stock Option Plan (1999 Plan)
The Companys 1999 Executive Stock Option Plan (1999 Plan)
has reserved 586,166 shares of common stock for issuance.
As of December 31, 2005, net of forfeiture, a total of
420,956 shares remain available for granting under this
plan.
Table of Contents
(iii)
2001 Stock Option Plan (2001 Plan)
Under the 2001 Stock Option Plan (2001 Plan), 1,800,000 shares
of the Companys common stock have been reserved for grant
of stock options to employees and consultants. Additionally, on
January 1 of each year, commencing January 1, 2002, the
number of shares reserved for grant under the 2001 Plan will
increase by the lesser of (i) 15% of the aggregate number
of shares available for grant under the 2001 Plan or
(ii) 300,000 shares. As of December 31, 2005, net of
forfeitures, a total of 2,423,320 shares remain available under
this plan.
(iv)
2001 Non-employee Director Stock Incentive Plan
Under the 2001 Non-employee Director Stock Incentive Plan (2001
Director Plan), 200,000 shares of the Companys common
stock have been reserved for grant of stock options to
non-employee directors of the Company. As of December 31,
2005, net of forfeitures, a total of 147,500 shares remain
available under this plan.
Options Outstanding
Weighted-
Number
Average
of Shares
Exercise Price
(In thousands except
weighted average)
1,208
1.24
895
0.10
(8
)
0.00
(301
)
1.27
1,794
0.71
(930
)
0.78
864
$
0.63
25
0.21
(49
)
0.08
(97
)
0.99
743
$
0.60
Options Outstanding
Weighted-
Options Exercisable
Average
Remaining
Weighted-
Weighted-
Number
Contractual
Average
Number
Average
Range of Exercise Prices
Outstanding
Life (Years)
Exercise Price
Exercisable
Exercise Price
(In thousands except weighted average)
430
7.6
$
0.11
292
$
0.11
188
4.0
0.85
188
0.85
102
5.3
1.25
102
1.25
23
6.0
4.93
23
4.94
743
6.3
$
0.60
605
$
0.71
Table of Contents
(e) Common Stock
Equivalents
Years Ended December 31
2003
2004
2005
(In thousands)
32,500
1,794
864
743
810
810
810
559
559
13,599
1,861
110,333
186,306
3,722
102,222
132,722
(f)
Employee Stock Purchase Plan
(g)
Employee 401(k) Plan
(h)
Stockholder Rights Agreement
Table of Contents
(5)
Related Party Transactions
(a)
Agreement with Medarex
(b)
Cognate Agreement
(6)
Income Taxes
Table of Contents
2003
2004
2005
$
14,699
$
17,126
$
20,450
1,136
1,319
1,525
627
981
927
355
313
325
16,817
19,739
23,227
(16,817
)
(19,739
)
(23,227
)
$
$
$
(7)
Scientific Collaboration Arrangements
(8)
Commitments and Contingencies
(a)
Lease Obligations
Capital
Operating
Leases
Leases
(in thousands)
$
11
$
324
3
14
$
324
1
13
10
$
3
Table of Contents
(b)
Legal Matters
(c)
Sales Tax Assessment
Table of Contents
(9)
Notes Payable
(a)
Notes Payable to Related Parties.
Management Loans
Toucan Capital Loans
Toucan Partners Loans
(10)
Unaudited Quarterly Financial Information (in thousands,
except loss per share data)
First
Second
Third
Fourth
Quarter
Quarter
Quarter
Quarter
2004
2004
2004
2004
$
127
$
116
$
91
$
56
$
(828
)
$
(1,019
)
$
(2,266
)
$
(4,395
)
First
Second
Third
Fourth
Quarter
Quarter
Quarter
Quarter
2004
2004
2004
2004
$
(0.04
)
$
(0.05
)
$
(0.12
)
$
(0.24
)
19,025
19,026
19,026
19,026
First
Second
Third
Fourth
Quarter
Quarter
Quarter
Quarter
2005
2005
2005
2005
$
87
$
8
$
15
$
14
$
(2,526
)
$
(2,638
)
$
(2,782
)
$
(1,987
)
$
(0.13
)
$
(0.14
)
$
(0.15
)
$
(0.10
)
19,035
19,078
19,078
19,078
Table of Contents
(11)
Loss on Sublease
(12)
Impairment and Disposal of Long-lived Assets
(13)
Subsequent Events
Loan Agreement
Private Placement
Table of Contents
Exercise of Management Warrants
Table of Contents
Table of Contents
II-1
II-2
II-3
II-4
II-5
II-6
II-7
Item 13.
Other Expenses of Issuance and Distribution.
Amount
$
2,430
$
30,000
$
30,000
$
100,000
$
3,000
$
$
165,430
Item 14.
Indemnification of Directors and Officers.
Table of Contents
Item 15.
Recent Sales of Unregistered Securities.
1. The Company sold an aggregate of 135,100 shares of
common stock to employees, directors and consultants for cash
consideration in the aggregate amount of $11,100 upon the
exercise of stock options and stock awards.
2. The Company granted stock options and stock awards to
employees, directors and consultants under its 1998 Stock Option
Plan, 1999 Executive Stock Option Plan, 2001 Stock Option Plan,
2001 Nonemployee Director Stock Incentive Plan and Employee
Stock Purchase Plan covering an aggregate of 385,000 shares
of common stock, with exercise prices ranging from $0.12 to
$0.21 per share. Of these, options covering an aggregate of
185,002 were cancelled without being exercised.
3. On November 13, 2003, the Company borrowed an
aggregate of $335,000 from members of its management, pursuant
to a series of convertible promissory notes which accrue
interest at a rate of prime plus 2% (and associated warrants to
purchase an aggregate of approximately 3.7 million shares
of our stock at $0.04 per share). In connection with the
financing with Toucan Capital Fund II, L.P. (Toucan
Capital) described below, the remaining $285,000 principal
amount of notes were amended to, among other things, reduce the
conversion prices to $0.10 per share. The notes that
remained outstanding were amended on a number of occasions to
extend their respective maturity dates.
4. Beginning in 2004, the Company raised an aggregate of
approximately $9 million in gross proceeds from issuances
of debt and equity through a series of private placements. These
financings included:
the sale of 32,500,000 shares of Series A Preferred
Stock to Toucan Capital at a price of $0.04 per share, or
an aggregate purchase price of $1.3 million (and an
associated warrant to purchase an aggregate of 13 million
shares of Series A Preferred Stock at an exercise price of
$0.04 per share) on January 26, 2005;
the issuance of a series of 10% convertible promissory
notes to Toucan Capital in aggregate principal amount of
approximately $6.75 million (and warrants to purchase an
aggregate of
Table of Contents
135.5 million shares at exercise prices ranging from $0.01
to $0.04 per share) from February 2004 through September
2005;
the issuance of a 10% convertible promissory note to Toucan
Partners, LLC (Toucan Partners) in principal amount
of $400,000 (and an associated warrant to
purchase 4 million shares at an exercise price of
$0.04 per share) in November 2005; and
the issuance of two 10% non-convertible promissory notes to
Toucan Partners in an aggregate principal amount of
approximately $550,000 from December 2005 through March 2006.
5. In April 2006, the Company sold 39,467,891 shares
of common stock (and accompanying warrants to purchase an
aggregate of 19,733,945 million shares of common stock at
an exercise price of $0.14 per share) to certain accredited
investors (the PIPE Financing) for aggregate
proceeds of approximately $5.5 million.
6. On April 7, 2006, the Company issued
482,091 shares of its common stock to an accredited
investor as a result of the net exercise of the warrant to
purchase 714,286 shares of common stock at
$0.14 per share acquired by such investor pursuant to the
Companys private placement of common stock and warrants
which closed on April 4, 2006.
7. On April 17, 2006, in exchange for agreeing to
consent to the PIPE Financing, the non-convertible notes held by
Toucan Partners were amended and restated in order to make them
convertible on the same terms and conditions as the convertible
note held by Toucan Partners and warrants to purchase an
aggregate of 5.5 million shares at an exercise price of
$0.04 per share were issued to Toucan Partners.
8. On April 17, 2006, Toucan Capital converted all of
its promissory notes, including all accrued interest thereon,
into an aggregate of 4,816,863 shares of a newly designated
series of preferred stock, Series A-1 Preferred Stock, in
accordance with the terms of the notes at a conversion price of
$1.60 per share.
9. From March 2006 through June 2006, the warrants referred
to in paragraph (3) above were exercised on a net
exercise basis for an aggregate of 3,459,705 shares.
Additionally, in March 2006, the promissory notes referred to in
paragraph (3) above, including all accrued interest
thereon, were converted in accordance with their terms into an
aggregate of 2,687,719 shares of common stock.
Table of Contents
Item 16.
Exhibits and Financial Statement Schedules
Exhibit
Number
Description
3
.1*
Seventh Amended and Restated Certificate of Incorporation, as
amended.
3
.2
Second Amended and Restated Bylaws of the Company.(3.2)(1)
3
.3
First Amendment to Second Amended and Restated Bylaws of the
Company.(3.1)(19)
3
.4
Certificate of Designations, Preferences and Rights of
Series A Cumulative Convertible Preferred Stock, as
amended.(3.3)(18)
3
.5
Certificate of Designations, Preferences and Rights of
Series A-1 Cumulative Convertible Preferred Stock.(3.4)(18)
4
.1
Form of common stock certificate.(4.1)(2)
4
.2
Northwest Biotherapeutics, Inc. Stockholders Rights Plan dated
February 26, 2002 between the Company and Mellon Investors
Services, LLC.(4.2)(3)
4
.3
Form of Rights Certificate.(4.1)(3)
4
.4
Rights Agreement Amendment dated April 26, 2004.(4.1)(4)
5
.1
Opinion of Johnston Law Firm as to the legality of the
securities being registered.(5.1)(21)
10
.1
Loan Agreement, Security Agreement and 10% Convertible,
Secured Promissory Note dated November 14, 2005 in the
principal amount of $400,000 between the Company and Toucan
Partners, LLC.(10.27)(5)
10
.2
Amended and Restated Loan Agreement, Security Agreement and 10%
Secured Promissory Note originally dated December 30, 2005,
and amended and restated on April 17, 2006 in the principal
amount of $250,000 between the Company and Toucan Partners,
LLC.(10.2)(18)
10
.3
Amended and Restated Loan Agreement, Security Agreement and 10%
Secured Promissory Note originally dated March 9, 2006, and
amended and restated on April 17, 2006 in the principal
amount of $300,000 between the Company and Toucan Partners,
LLC.(10.3)(18)
10
.4
Amended and Restated Investor Rights Agreement dated
April 17, 2006.(10.4)(18)
10
.5
Securities Purchase Agreement, dated March 30, 2006 by and
among the Company and the Investors identified therein.(10.1)(6)
10
.6
Form of Warrant.(10.2)(6)
10
.7
Warrant to purchase securities of the Company dated
April 26, 2004 issued to Toucan Capital Fund II,
L.P.(10.9)(7)
10
.8
Warrant to purchase securities of the Company dated
June 11, 2004 issued to Toucan Capital Fund II,
L.P.(10.8)(7)
10
.9
Warrant to purchase securities of the Company dated
July 30, 2004 issued to Toucan Capital Fund II,
L.P.(10.7)(7)
10
.10
Warrant to purchase securities of the Company dated
October 22, 2004 issued to Toucan Capital Fund II,
L.P.(10.3)(8)
10
.11
Warrant to purchase securities of the Company dated
November 10, 2004 issued to Toucan Capital Fund II,
L.P.(10.3)(9)
10
.12
Warrant to purchase securities of the Company dated
December 27, 2005 issued to Toucan Capital Fund II,
L.P.(10.3)(10)
10
.13
First Amendment to Warrants between Northwest Biotherapeutics,
Inc. and Toucan Capital Fund II, L.P. dated
January 26, 2005.(10.5)(1)
10
.14
Warrant to purchase Series A Preferred Stock dated
January 26, 2005 issued to Toucan Capital Fund II,
L.P.(10.2)(1)
10
.15
Warrant to purchase securities of the Company dated
April 12, 2005 issued to Toucan Capital Fund II,
L.P.(10.39)(11)
Table of Contents
Exhibit
Number
Description
10
.16
Warrant to purchase securities of the Company dated May 13,
2005 issued to Toucan Capital Fund II, L.P.(10.3)(12)
10
.17
Warrant to purchase securities of the Company dated
June 16, 2005 issued to Toucan Capital Fund II,
L.P.(10.3)(13)
10
.18
Warrant to purchase securities of the Company dated
July 26, 2005 issued to Toucan Capital Fund II,
L.P.(10.3)(14)
10
.19
Warrant to purchase securities of the Company dated
September 7, 2005 issued to Toucan Capital Fund II,
L.P.(10.3)(15)
10
.20
Warrant to purchase securities of the Company dated
November 14, 2005 issued to Toucan Partners, LLC.(10.17)(5)
10
.21
Warrant to purchase securities of the Company dated
April 17, 2006 issued to Toucan Partners, LLC.(10.21)(18)
10
.22
Warrant to purchase securities of the Company dated
April 17, 2006 issued to Toucan Partners, LLC.(10.22)(18)
10
.23
Amended and Restated Recapitalization Agreement by and between
the Company and Toucan Capital Fund II, L.P., as
amended.(10.23)(18)
10
.24
Amended and Restated Binding Term sheet, as amended.(10.24)(18)
10
.25
Amended and Restated Employment Agreement with Dr. Alton L.
Boynton(10.1)(16)
10
.26
Employment Agreement with Paul Zeltzer.(99.1)(17)
10
.27
Form of Warrant to purchase common stock of the Company dated
November 13, 2003, as amended.(10.27)(18)
10
.28
Services Proposal between the Company and Cognate Therapeutics,
Inc. dated July 30, 2004.(10.35)(20) (portions of exhibit
omitted pursuant to confidential treatment request filed
separately with the Commission)
10
.29
1998 Stock Option Plan.(10.15)(2)
10
.30
1999 Executive Stock Option Plan.(10.16)(2)
10
.31
2001 Stock Option Plan.(10.17)(2)
10
.32
2001 Nonemployee Director Stock Incentive Plan.(10.18)(2)
10
.33
Employee Stock Purchase Plan.(10.19)(2)
10
.34
Lease Agreement.(10.34)(18)
10
.35
Clinical Study Agreement between the Company and the Regents of
the University of California dated February 14,
2006.(10.35)(18)
11
.1
Computation of net loss per share (included in notes to
financial statements).
23
.1*
Consent of KPMG LLP, Independent Registered Accounting Firm.
23
.2*
Consent of Peterson Sullivan, PLLC, Independent Registered
Accounting Firm.
23
.3
Consent of Johnston Law Firm, included in the opinion filed as
Exhibit 5.1.(5.1)(21)
(1)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K,
February 1, 2005.
(2)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants
Form
S-1
(Registration
No.
333-67350).
(3)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants
Form
8-A
on
July 8, 2002.
(4)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants
Form
10-K
on
May 14, 2004.
(5)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Quarterly Report on
Form
10-Q
on
November 14, 2005.
Table of Contents
(6)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K
on
March 31, 2006.
(7)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Quarterly Report on
Form
10-Q
on
November 15, 2004.
(8)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K
on
October 22, 2004.
(9)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K
on
November 10, 2004.
(10)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K
on
December 27, 2004.
(11)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Annual Report on
Form
10-K
on
April 15, 2005.
(12)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K
on
May 18, 2005.
(13)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K
on
June 21, 2005.
(14)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K
on
August 1, 2005.
(15)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K
on
September 9, 2005.
(16)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Quarterly Report on
Form
10-Q
on
November 11, 2003.
(17)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K
on
August 5, 2005.
(18)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants
Form
10-K
on
April 18, 2006.
(19)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K
on
April 26, 2006.
(20)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants
Form
10-K/A
on
June 30, 2006.
(21)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Registration
Statement on
Form
S-1
on
May 19, 2006.
*
Filed herewith
(1) To file, during any period in which offers or sales are
being made, a post-effective amendment to this registration
statement:
(i) To include any prospectus required by
Section 10(a)(3) of the Securities Act of 1933, as
amended; and
(ii) To reflect in the prospectus any facts or events
arising after the effective date of the registration statement
(or the most recent post-effective amendment thereof) which,
individually or in the aggregate, represent a fundamental change
in the information in the registration statement.
Notwithstanding the foregoing, any increase or decrease in
volume of securities offered (if the total dollar value of
securities offered would not exceed that which was registered)
and any deviation from the low or high end of the estimated
maximum offering range may be reflected in the form of
prospectus filed with the Commission pursuant to Rule 424(b)
Table of Contents
(§230.424(b) of this chapter) if, in the aggregate, the
changes in volume and price represent no more than a 20% change
in the maximum aggregate offering price set forth in the
Calculation of Registration Fee table in the
effective registration statement; and
(iii) To include any material information with respect to
the plan of distribution not previously disclosed in the
registration statement or any material change to such
information in the registration statement.
(2) That, for purposes of determining any liability under
the Securities Act of 1933, as amended, each such post-effective
amendment shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering as
such securities at that time shall be deemed to be the initial
bona fide offering thereof.
(3) To remove from registration by means of a
post-effective amendment any of the securities being registered
which remain unsold at the termination of the offering.
(i) For purposes of determining any liability under the
Securities Act of 1933, the information omitted from the form of
prospectus filed as part of this registration statement in
reliance under Rule 430A and contained in a form of
prospectus filed by the registrant pursuant to
Rule 424(b)(1) or (4), or 497(h) under the Securities Act
of 1933 shall be deemed to be part of this registration
statement as of the time it was declared effective.
(ii) For the purpose of determining any liability under the
Securities Act of 1933, each post-effective amendment that
contains a form of prospectus shall be deemed to be a new
registration statement relating to the securities offered
therein, and the offering of such securities at that time shall
be deemed to be the initial bona fide offering thereof.
Table of Contents
II-8
Pursuant to the requirements of the Securities Act of 1933, as
amended, the registrant certifies has duly caused this
registration statement to be signed on its behalf by the
undersigned, thereunto duly authorized, in the City of Bothell,
State of Washington, on July 17, 2006.
NORTHWEST BIOTHERAPEUTICS, INC.
By:
/s/ ALTON L. BOYNTON
Alton L. Boynton
Its: President, Chief Operating and Scientific Officer
Signature
Title
Date
/s/
ALTON L.
BOYNTON, PH.D.
Director, Principal Executive Officer and Principal Financial
and Accounting Officer
July 17, 2006
Table of Contents
Exhibit
Number
Description
3
.1*
Seventh Amended and Restated Certificate of Incorporation, as
amended.
3
.2
Second Amended and Restated Bylaws of the Company.(3.2)(1)
3
.3
First Amendment to Second Amended and Restated Bylaws of the
Company.(3.1)(19)
3
.4
Certificate of Designations, Preferences and Rights of
Series A Cumulative Convertible Preferred Stock, as
amended.(3.3)(18)
3
.5
Certificate of Designations, Preferences and Rights of
Series A-1 Cumulative Convertible Preferred Stock.(3.4)(18)
4
.1
Form of common stock certificate.(4.1)(2)
4
.2
Northwest Biotherapeutics, Inc. Stockholders Rights Plan dated
February 26, 2002 between the Company and Mellon Investors
Services, LLC.(4.2)(3)
4
.3
Form of Rights Certificate.(4.1)(3)
4
.4
Rights Agreement Amendment dated April 26, 2004.(4.1)(4)
5
.1
Opinion of Johnston Law Firm as to the legality of the
securities being registered.(5.1)(21)
10
.1
Loan Agreement, Security Agreement and 10% Convertible,
Secured Promissory Note dated November 14, 2005 in the
principal amount of $400,000 between the Company and Toucan
Partners, LLC.(10.27)(5)
10
.2
Amended and Restated Loan Agreement, Security Agreement and 10%
Secured Promissory Note originally dated December 30, 2005,
and amended and restated on April 17, 2006 in the principal
amount of $250,000 between the Company and Toucan Partners,
LLC.(10.2)(18)
10
.3
Amended and Restated Loan Agreement, Security Agreement and 10%
Secured Promissory Note originally dated March 9, 2006, and
amended and restated on April 17, 2006 in the principal
amount of $300,000 between the Company and Toucan Partners,
LLC.(10.3)(18)
10
.4
Amended and Restated Investor Rights Agreement dated
April 17, 2006.(10.4)(18)
10
.5
Securities Purchase Agreement, dated March 30, 2006 by and
among the Company and the Investors identified therein.(10.1)(6)
10
.6
Form of Warrant.(10.2)(6)
10
.7
Warrant to purchase securities of the Company dated
April 26, 2004 issued to Toucan Capital Fund II,
L.P.(10.9)(7)
10
.8
Warrant to purchase securities of the Company dated
June 11, 2004 issued to Toucan Capital Fund II,
L.P.(10.8)(7)
10
.9
Warrant to purchase securities of the Company dated
July 30, 2004 issued to Toucan Capital Fund II,
L.P.(10.7)(7)
10
.10
Warrant to purchase securities of the Company dated
October 22, 2004 issued to Toucan Capital Fund II,
L.P.(10.3)(8)
10
.11
Warrant to purchase securities of the Company dated
November 10, 2004 issued to Toucan Capital Fund II,
L.P.(10.3)(9)
10
.12
Warrant to purchase securities of the Company dated
December 27, 2005 issued to Toucan Capital Fund II,
L.P.(10.3)(10)
10
.13
First Amendment to Warrants between Northwest Biotherapeutics,
Inc. and Toucan Capital Fund II, L.P. dated
January 26, 2005.(10.5)(1)
10
.14
Warrant to purchase Series A Preferred Stock dated
January 26, 2005 issued to Toucan Capital Fund II,
L.P.(10.2)(1)
10
.15
Warrant to purchase securities of the Company dated
April 12, 2005 issued to Toucan Capital Fund II,
L.P.(10.39)(11)
10
.16
Warrant to purchase securities of the Company dated May 13,
2005 issued to Toucan Capital Fund II, L.P.(10.3)(12)
10
.17
Warrant to purchase securities of the Company dated
June 16, 2005 issued to Toucan Capital Fund II,
L.P.(10.3)(13)
10
.18
Warrant to purchase securities of the Company dated
July 26, 2005 issued to Toucan Capital Fund II,
L.P.(10.3)(14)
Table of Contents
Exhibit
Number
Description
10
.19
Warrant to purchase securities of the Company dated
September 7, 2005 issued to Toucan Capital Fund II,
L.P.(10.3)(15)
10
.20
Warrant to purchase securities of the Company dated
November 14, 2005 issued to Toucan Partners, LLC.(10.17)(5)
10
.21
Warrant to purchase securities of the Company dated
April 17, 2006 issued to Toucan Partners, LLC.(10.21)(18)
10
.22
Warrant to purchase securities of the Company dated
April 17, 2006 issued to Toucan Partners, LLC.(10.22)(18)
10
.23
Amended and Restated Recapitalization Agreement by and between
the Company and Toucan Capital Fund II, L.P., as
amended.(10.23)(18)
10
.24
Amended and Restated Binding Term sheet, as amended.(10.24)(18)
10
.25
Amended and Restated Employment Agreement with Dr. Alton L.
Boynton(10.1)(16)
10
.26
Employment Agreement with Paul Zeltzer.(99.1)(17)
10
.27
Form of Warrant to purchase common stock of the Company dated
November 13, 2003, as amended.(10.27)(18)
10
.28
Services Proposal between the Company and Cognate Therapeutics,
Inc. dated July 30, 2004.(10.35)(20) (portions of exhibit
omitted pursuant to confidential treatment request filed
separately with the Commission)
10
.29
1998 Stock Option Plan.(10.15)(2)
10
.30
1999 Executive Stock Option Plan.(10.16)(2)
10
.31
2001 Stock Option Plan.(10.17)(2)
10
.32
2001 Nonemployee Director Stock Incentive Plan.(10.18)(2)
10
.33
Employee Stock Purchase Plan.(10.19)(2)
10
.34
Lease Agreement.(10.34)(18)
10
.35
Clinical Study Agreement between the Company and the Regents of
the University of California dated February 14,
2006.(10.35)(18)
11
.1
Computation of net loss per share (included in notes to
financial statements).
23
.1*
Consent of KPMG LLP, Independent Registered Accounting Firm.
23
.2*
Consent of Peterson Sullivan, PLLC, Independent Registered
Accounting Firm.
23
.3
Consent of Johnston Law Firm, included in the opinion filed as
Exhibit 5.1.(5.1)(21)
(1)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K,
February 1, 2005.
(2)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants
Form
S-1
(Registration
No.
333-67350).
(3)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants
Form
8-A
on
July 8, 2002.
(4)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants
Form
10-K
on
May 14, 2004.
(5)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Quarterly Report on
Form
10-Q
on
November 14, 2005.
(6)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K
on
March 31, 2006.
(7)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Quarterly Report on
Form
10-Q
on
November 15, 2004.
(8)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K
on
October 22, 2004.
Table of Contents
(9)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K
on
November 10, 2004.
(10)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K
on
December 27, 2004.
(11)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Annual Report on
Form
10-K
on
April 15, 2005.
(12)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K
on
May 18, 2005.
(13)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K
on
June 21, 2005.
(14)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K
on
August 1, 2005.
(15)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K
on
September 9, 2005.
(16)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Quarterly Report on
Form
10-Q
on
November 11, 2003.
(17)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K
on
August 5, 2005.
(18)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants
Form
10-K
on
April 18, 2006.
(19)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Current Report on
Form
8-K
on
April 26, 2006.
(20)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants
Form
10-K/A
on
June 30, 2006.
(21)
Incorporated by reference to the exhibit shown in the preceding
parentheses filed with the Registrants Registration
Statement on
Form
S-1
on
May 19, 2006.
*
Filed herewith
SEVENTH AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION
OF
NORTHWEST BIOTHERAPEUTICS, INC.
The undersigned, Alton L. Boynton, hereby certifies that:
1. He is the duly elected and acting President and Secretary of Northwest Biotherapeutics, Inc., a Delaware corporation.
2. The Certificate of Incorporation of this corporation was originally filed with the Secretary of State of Delaware on July 29, 1998.
3. The First Amended and Restated Certificate of Incorporation of this corporation was filed with the Secretary of State of Delaware on September 15, 1998.
4. The Second Amended and Restated Certificate of Incorporation of this corporation was filed with the Secretary of State of Delaware on March 26, 1999.
5. The Third Amended and Restated Certificate of Incorporation of this corporation was filed with the Secretary of State of Delaware on October 24, 2000.
6. The Fourth Amended and Restated Certificate of Incorporation of this corporation was filed with the Secretary of State of Delaware on June 1, 2001.
7. The Fifth Amended and Restated Certificate of Incorporation of this corporation was filed with the Secretary of State of Delaware on June 26, 2001.
8. The Sixth Amended and Restated Certificate of Incorporation of this corporation was filed with the Secretary of State of Delaware on July 3, 2002.
9. The Certificate of Incorporation of this corporation shall be amended and restated to read in full as follows:
ARTICLE I
The name of the corporation is Northwest Biotherapeutics, Inc.
(the "Corporation")
ARTICLE II
The address of the Corporation's registered office in the State of Delaware is 2711 Centerville Road, Suite 400, Wilmington, Delaware 19808, County of New Castle. The name of its registered agent at such address is Corporation Service Company.
ARTICLE III
The purpose of the Corporation is to engage in any lawful act or activity for which corporations may be organized under the Delaware General Corporation Law.
ARTICLE IV
CAPITALIZATION
1. Authorized Capital.
(a) The total number of shares of stock that the Corporation shall have the authority to issue is 1,100,000,000 shares of capital stock, consisting of (i) 300,000,000 shares of preferred stock, par value $0.001 per share (the "Preferred Stock"), and (ii) 800,000,000 shares of common stock, par value $0.001 per share (the "Common Stock").
(b) Subject to the provisions of this Certificate of Incorporation and the Preferred Stock Designation (as defined below) creating any series of Preferred Stock, the Corporation may issue shares of its capital stock from time to time for such consideration (not less than the par value thereof) as may be fixed by the Board of Directors of the Corporation (the "Board of Directors"), which is expressly authorized to fix the same in its absolute discretion subject to the foregoing conditions. Shares so issued for which the consideration shall have been paid or delivered to the Corporation shall be deemed fully paid stock and shall not be liable to any further call or assessment thereon, and the holders of such shares shall not be liable for any further payments in respect of such shares.
(c) The right to cumulate votes for the election of directors as provided in Section 214 of the DGCL shall not be granted and is hereby expressly denied.
(d) No stockholder of the Corporation shall by reason of his/her/its holding shares of any class of capital stock of the Corporation have any preemptive or preferential right to acquire or subscribe for any additional, unissued or treasury shares (whether now or hereafter acquired) of any class of capital stock of the Corporation now or hereafter to be authorized, or any notes, debentures, bonds of other securities convertible into or carrying any right, option or warrant to subscribe for or acquire shares of any class of capital stock of the Corporation now or hereafter to be authorized, whether or not the issuance of any such shares or such notes, debentures, bonds or other securities would adversely affect the dividends or voting or other rights of that stockholder.
2. Preferred Stock.
(a) The Preferred Stock may be issued from time to time in one or more series. Authority is hereby expressly granted to and vested in the Board of Directors to authorize from time to time the issuance of Preferred Stock in one or more series. With respect to each series of Preferred Stock authorized by it, the Board of Directors shall be authorized to establish by resolution or resolutions, and by filing a certificate pursuant to
applicable law of the State of Delaware (the "Preferred Stock Designation"), the following to the fullest extent now or hereafter permitted by the DGCL:
(1) the designation of such series;
(2) the number of shares to constitute such series;
(3) whether such series is to have voting rights (full, special or limited) or is to be without voting rights;
(4) if such series is to have voting rights, whether or not such series is to be entitled to vote as a separate class either alone or together with the holders of the Common Stock or one or more other series of Preferred Stock;
(5) the preferences and relative, participating, optional, conversion or other special rights (if any) of such series and the qualifications, limitations or restrictions (if any) with respect to such series;
(6) the redemption rights and price(s), if any, of such series, and whether or not the shares of such series shall be subject to the operation of retirement or sinking funds to be applied to the purchase or redemption of such shares for retirement and, if such retirement or sinking funds or funds are to be established, the periodic amount thereof and the terms and provisions relative to the operation thereof;
(7) the dividend rights and preferences (if any) of such series, including, without limitation, (i) the rates of dividends payable thereon, (ii) the conditions upon which and the time when such dividends are payable, (iii) whether or not such dividends shall be cumulative or noncumulative and, if cumulative, the date or dates from witch such dividends shall accumulate and (iv) whether or not the payment of such dividends shall be preferred to the payment of dividends payable on the Common Stock or any other series of Preferred Stock;
(8) the preferences (if any), and the amounts thereof, which the holders of such series shall be entitled to receive upon the voluntary or involuntary liquidation, dissolution or winding-up of, or upon any distribution of the assets of, the Corporation;
(9) whether or not the shares of such series, at the option of the Corporation or the holders thereof or upon the happening of any specified event, shall be convertible into or exchangeable for (i) shares of Common Stock, (ii) shares of any other series of Preferred Stock or (iii) any other stock or securities of the Corporation;
(10) if such series is to be convertible or exchangeable, the price or prices or ratio or ratios or rate or rates at which such conversion or exchange may be made and the terms and conditions (if any) upon which such price or prices or ratio or ratios or rate or rates may be adjusted; and
(11) such other rights, powers and preferences with respect to such series as may to the Board of Directors seem advisable.
Any series of Preferred Stock may vary from any other series of Preferred Stock in any or all of the foregoing respects and in any other manner.
(b) The Board of Directors may, with respect to any existing series of Preferred Stock but subject to the Preferred Stock Designation creating such series, (i) increase the number of shares of Preferred Stock designated for such series by a resolution adding to such series authorized and unissued shares of Preferred Stock not designated for any other series and (ii) decrease the number of shares of Preferred Stock designated for such series by a resolution subtracting from such series of Preferred Stock designated for such series (but not below the number of shares of such series then outstanding), and the shares so subtracted shall become authorized, unissued and undesignated shares of Preferred Stock.
(c) No vote of the holders of the Common Stock or the Preferred Stock shall, unless otherwise expressly provided in a Preferred Stock Designation creating any series of Preferred Stock, be a prerequisite to the issuance of any shares of any series of the Preferred Stock authorized by and complying with the conditions of this Certificate of Incorporation. Shares of any series of Preferred Stock that have been authorized for issuance pursuant to this Certificate of Incorporation and that have been issued and reacquired in any manner by the Corporation (including upon conversion or exchange thereof) shall be restored to the status of authorized and unissued shares of Preferred Stock and may be reissued as part of a new series of Preferred Stock to be created by resolution or resolutions of the Board of Directors and a Preferred Stock Designation as set forth above.
3. Common Stock.
(a) The holders of shares of Common Stock shall be entitled to vote upon all matters submitted to a vote of the common stockholders of the Corporation and shall be entitled to one vote for each share of the Common Stock held.
(b) Subject to the prior rights and preferences (if any) applicable to shares of Preferred Stock of any series, the holders of shares of the Common Stock shall be entitled to receive such dividends (payable in cash, stock or otherwise) as may be declared thereon by the Board of Directors at any time and from time to time out of any funds of the Corporation legally available therefore.
(c) In the event of any voluntary or involuntary liquidation, dissolution or winding-up of the Corporation, after payment or provision for payment of the debts and other liabilities of the Corporation and subject to the preferential or other rights (if any) of the holders of shares of the Preferred Stock in respect thereof, the holders of shares of the Common Stock shall be entitled to receive all the remaining assets of the Corporation available for distribution to its stockholders, ratably in proportion to the number of shares of the Common Stock held by them. For purposes of this paragraph (c), a liquidation,
dissolution or winding-up of the Corporation shall not be deemed to be occasioned by or to include (i) any consolidation or merger of the Corporation with or into another corporation or other entity or (ii) a sale, lease, exchange or conveyance of all or a part of the assets of the Corporation.
4. Stock Options, Warrants, etc. Unless otherwise expressly prohibited in the Preferred Stock Designation creating any series of Preferred Stock, the Corporation shall have authority to create and issue warrants, rights and options entitling the holders thereof to purchase from the Corporation shares of the Corporation's capital stock of any class or series or other securities of the Corporation for such consideration and to such persons, firms or corporations as the Board of Directors, in its sole discretion, may determine, setting aside from the authorized but unissued capital stock of the Corporation the requisite number of shares for issuance upon the exercise of such warrants, rights or options. Such warrants, rights and options shall be evidenced by one or more instruments approved by the Board of Directors. The Board of Directors shall be empowered to set the exercise price, duration, time for exercise and other terms of such warrants, rights or options; provided, however, that the consideration to be received for any shares of capital stock subject thereto shall not be less than the par value thereof.
ARTICLE V
The Board of Directors of the Corporation is expressly authorized to adopt, amend or repeal Bylaws or adopt new Bylaws; provided however, that the Board of Directors may not repeal or amend any bylaw that stockholders have expressly provided may not be amended or repealed by the Board of Directors. The stockholders shall also have the power to adopt, amend or repeal the Bylaws of this Corporation by the affirmative vote of the holders of not less than two-thirds of the outstanding shares entitled to vote thereon and, to the extent, if any, provided by resolution adopted by the Board of Directors authorizing the issuance of a class or series of Common Stock or Preferred Stock, by the affirmative vote of the holders of not less than two-thirds of the outstanding shares class or series, voting as separate group.
ARTICLE VI
(A) Board of Directors. The business and affairs of the Corporation shall be managed under the direction of the Board of Directors, the number of which shall be fixed from time to time exclusively by the Board of Directors pursuant to a resolution adopted by a majority of the total number of authorized directors (whether or not there exist any vacancies in previously authorized directorships at the time any such resolution is presented to the Board for adoption) (the "Whole Board"). The Directors shall be classified with respect to the time for which they shall severally hold office by dividing them into three classes, Class I, Class II and Class III, each consisting as nearly as possible of one-third of the Whole Board. All Directors shall hold office until their successors are elected and qualified, or until their earlier death, resignation, disqualification or removal. Class I Directors shall be elected for a term of one year; Class II Directors shall be elected for a term of two years; and Class III Directors shall be elected for a term of three years; and at each annual stockholders' meeting thereafter, successors to the Directors whose terms shall expire that year shall be
elected to hold office for a term of three years, so that the term of office of
one class of Directors shall expire in each year. Any vacancy on the Board of
Directors that results from an increase in the number of Directors may be filled
by the affirmative vote of a majority of the Directors then in office and a
majority of the Continuing Directors, voting separately and as a subclass of
Directors, and other vacancy on the Board of Directors may be filled by the
affirmative vote of a majority of the Directors then in office, although less
than a quorum, or by a sole remaining Director. Any Director elected to fill a
vacancy not resulting from an increase in the number of Directors shall serve
for a term equivalent to the remaining unserved portion of the term of such
newly elected Director's predecessor. Notwithstanding the foregoing, whenever
the holders of any one or more classes or series, to elect Directors at an
annual or special meeting of stockholders, the election, term of office, filling
of vacancies and other features of such Directorships shall be governed by the
terms of this Amended and Restated Certificate of Incorporation applicable
thereto, and such Directors shall not be divided into classes pursuant to this
Section (A) unless expressly provided by such terms.
(B) Removal of Directors by Stockholders. A Director may be removed from office only for "cause" at a special meeting of stockholders called for that purpose, by the affirmative vote of the holders of not less than two-thirds of the shares entitled to elect the Director or Directors whose removal is being sought. The vacancy created by the removal of any Director under this Section (B) shall be filled only by the affirmative vote of the holders of at least two-thirds of the shares entitled to elect the Director who was removed. As used herein, "cause" shall mean (a) willful and continued material failure, refusal or inability to perform the Director's duties to the corporation or the willful engaging in gross misconduct that is materially and demonstrably damaging to the corporation; or (b) conviction for any crime involving moral turpitude or any other illegal act that materially and adversely reflects upon the business, affairs or reputation of the corporation or on the Director's ability to perform the Director's duties to the Corporation.
ARTICLE VII
(A) To the fullest extent permitted by the Delaware General Corporation Law, as the same exists or as may hereafter be amended, a director of the Corporation shall not be personally liable to the Corporation or its stockholders for monetary damages for breach of fiduciary duty as a director.
(B) The Corporation shall indemnify to the fullest extent permitted by law any person made or threatened to be made a party to an action or proceeding, whether criminal, civil, administrative or investigative, by reason of the fact that he, his testator or interstate is or was a director or officer of the Corporation or any predecessor of the Corporation, or serves or served at any other enterprise as a director or officer at the request of the Corporation or any predecessor to the Corporation.
(C) Neither any amendment nor repeal of this Article VII, nor the adoption of any provision of the Corporation's Certificate of Incorporation inconsistent with this Article VII, shall eliminate or reduce the effect of this Article VII in respect of any matter occurring, or
any action or proceeding accruing or arising or that, but for this Article VII, would accrue or arise, prior to such amendment, repeal or adoption of any inconsistent provision.
ARTICLE VIII
(A) Amendments to Restated Certificate of Incorporation. The following Articles and Sections may be amended or repealed only upon the affirmative vote of the holders of at least two-thirds of the outstanding shares and, to the extent, if any, provided by resolution adopted by the Board of Directors authorizing the issuance of a class or series of Common Stock or Preferred Stock, by the affirmative vote of the holders of at least two-thirds of the outstanding shares of such class or series, voting as a separate voting group:
Article V ("Bylaws");
Article VI ("Directors");
Article VII ("Limitation of Directors Liability");
Article VIII ("Amendments to Restated Certificate of Incorporation");
Article IX ("Business Combinations").
ARTICLE IX
(A) Business Combinations.
1. Definitions. For the purposes of the Article IX:
a. "Business Combination" means (i) a merger, share exchange or consolidation of this corporation or any of its Subsidiaries with any other corporation; (ii) the sale, lease, exchange, mortgage, pledge, transfer or other disposition or encumbrance, whether in one transaction or a series of transactions, by this corporation or any of its Subsidiaries of all or a substantial part of this corporation's assets otherwise than in the usual and regular course of business; or (iii) any agreement, contract or other arrangement providing for any of the foregoing transactions.
b. "Subsidiary" means a domestic or foreign corporation, a majority of the outstanding voting shares of which are owned, directly or indirectly, by this corporation.
2. Information Considered by Board of Directors. In considering a Business Combination, the Board of Directors may take into account factors in addition to potential economic benefits to the stockholders, including without limitation (i) comparison of the proposed consideration to be received by stockholders in relation to the then current market price of the corporation's capital stock, the estimated current value of the corporation in a freely negotiated transaction and the estimated future value of the corporation as an
independent entity, and (ii) the impact of such a transaction on the employees, suppliers and customers of the corporation and its effect on the communities in which the corporation operates.
The foregoing Seventh Amended and Restated Certificate of Incorporation has been duly adopted by the Corporation's Board of Directors and stockholders in accordance with the applicable provisions of Sections 228, 242 and 245 of the General Corporation Law of the State of Delaware
Executed at Bothell, Washington on May 25, 2006
/s/ Alton L. Boynton ----------------------------------------- Alton L. Boynton, President and Secretary |
Exhibit 23.1
Consent of Independent Registered Public Accounting Firm
The Board of Directors
Northwest Biotherapeutics, Inc.:
We consent to the use of our report dated March 12, 2004, except as to note 2, which is as of April 26, 2004, with respect to the statements of operations, stockholders' equity (deficit) and comprehensive loss, and cash flows for the year ended December 31, 2003 and the period from March 18, 1996 (inception) through December 31, 2003 (which period does not appear herein) of Northwest Biotherapeutics, Inc. (a development stage company), incorporated herein by reference and to the reference to our firm under the heading "Experts" in the prospectus.
Our report dated March 12, 2004, except as to note 2, which is as of April 26, 2004, contains an explanatory paragraph that states that Northwest Biotherapeutics, Inc. has experienced recurring losses from operations, has a working capital deficit and has a deficit accumulated in the development stage which raise substantial doubt about its ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of that uncertainty.
/s/ KPMG LLP Seattle, Washington July 14, 2006 |
[Peterson Sullivan PLLC Letterhead]
Exhibit 23.2
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the inclusion in the second amendment to the Registration Statement (No. 333-134320) on Form S-1 of Northwest Biotherapeutics, Inc. of our report dated January 25, 2006, on our audit of the balance sheets of Northwest Biotherapeutics, Inc. (a development stage company) as of December 31, 2005 and 2004, and the related statements of operations, stockholders' equity (deficit), and cash flows for the years ended December 31, 2005 and 2004, and for the period from March 18, 1996 (date of inception) to December 31, 2005.
Our report, dated January 25, 2006, except with respect to the subsequent events referred to in Note 13, the date for which is March 30, 2006, contains an explanatory paragraph that states that Northwest Biotherapeutics, Inc. 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. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
We also consent to the reference to our firm under the caption "Experts."
/s/ PETERSON SULLIVAN PLLC July 14, 2006 Seattle, Washington |