Item 1. Financial Statements
NORTHWEST BIOTHERAPEUTICS, INC.
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS
(in thousands, except per share data)
|
|
March 31, 2013
(Unaudited)
|
|
|
December 31,
2012
|
|
ASSETS
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
373
|
|
|
$
|
7,346
|
|
Prepaid expenses and other current assets
|
|
|
39
|
|
|
|
112
|
|
Total current assets
|
|
|
412
|
|
|
|
7,458
|
|
|
|
|
|
|
|
|
|
|
Property and equipment:
|
|
|
|
|
|
|
|
|
Laboratory equipment
|
|
|
60
|
|
|
|
60
|
|
Office furniture and other equipment
|
|
|
172
|
|
|
|
172
|
|
Less accumulated depreciation and amortization
|
|
|
(140
|
)
|
|
|
(137
|
)
|
Property and equipment, net
|
|
|
92
|
|
|
|
95
|
|
Deposit and other non-current assets
|
|
|
17
|
|
|
|
17
|
|
Total assets
|
|
$
|
521
|
|
|
$
|
7,570
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES, REDEEMABLE COMMON STOCK AND STOCKHOLDERS' DEFICIT
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable (includes related party of $8,482 and $3,397 in 2013 and 2012, respectively)
|
|
$
|
13,055
|
|
|
$
|
8,165
|
|
Accrued expenses (includes related party of $0 and $28 in 2013 and 2012, respectively)
|
|
|
1,083
|
|
|
|
589
|
|
Note payable (includes related party of $400 and $0 in 2013 and 2012, respectively)
|
|
|
1,334
|
|
|
|
934
|
|
Convertible notes, net (includes related party of $50 and $0 in 2013 and 2012, respectively)
|
|
|
767
|
|
|
|
1,056
|
|
Total current liabilities
|
|
|
16,239
|
|
|
|
10,744
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities:
|
|
|
|
|
|
|
|
|
Convertible notes payable, net
|
|
|
1,316
|
|
|
|
1,882
|
|
Total liabilities
|
|
|
17,555
|
|
|
|
12,626
|
|
|
|
|
|
|
|
|
|
|
Redeemable common stock ($0.001 par value)
|
|
|
11,017
|
|
|
|
11,017
|
|
|
|
|
|
|
|
|
|
|
Stockholders' deficit:
|
|
|
|
|
|
|
|
|
Preferred stock ($0.001 par value); 40,000,000 shares authorized; 0 shares issued and outstanding as of March 31, 2013 and December 31, 2012, respectively
|
|
|
-
|
|
|
|
-
|
|
Common stock ($0.001 par value); 450,000,000 shares authorized; 27,140,417 and 26,545,828 shares issued and outstanding as of March 31, 2013 and December 31, 2012, respectively
|
|
|
27
|
|
|
|
27
|
|
Additional paid-in capital
|
|
|
305,604
|
|
|
|
303,188
|
|
Deficit accumulated during the development stage
|
|
|
(333,492
|
)
|
|
|
(319,098
|
)
|
Cumulative translation adjustment
|
|
|
(190
|
)
|
|
|
(190
|
)
|
Total stockholders' deficit
|
|
|
(28,051
|
)
|
|
|
(16,073
|
)
|
|
|
|
|
|
|
|
|
|
Total liabilities, redeemable common stock and stockholders' deficit
|
|
$
|
521
|
|
|
$
|
7,570
|
|
See accompanying notes to the consolidated
financial statements
NORTHWEST BIOTHERAPEUTICS, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(Unaudited)
|
|
Three Months Ended March 31,
|
|
|
Period from
Inception (March
18, 1996) to
|
|
|
|
2013
|
|
|
2012
|
|
|
March 31, 2013
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research material sales
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
580
|
|
Contract research and development from related parties
|
|
|
-
|
|
|
|
-
|
|
|
|
1,128
|
|
Research grants and other
|
|
|
137
|
|
|
|
-
|
|
|
|
1,970
|
|
Total revenues
|
|
|
137
|
|
|
|
-
|
|
|
|
3,678
|
|
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of research material sales
|
|
|
-
|
|
|
|
-
|
|
|
|
382
|
|
Research and development
|
|
|
11,608
|
|
|
|
3,580
|
|
|
|
130,780
|
|
General and administration
|
|
|
2,470
|
|
|
|
2,183
|
|
|
|
93,469
|
|
Depreciation and amortization
|
|
|
3
|
|
|
|
2
|
|
|
|
2,380
|
|
Loss on facility sublease
|
|
|
-
|
|
|
|
-
|
|
|
|
895
|
|
Asset impairment loss
|
|
|
-
|
|
|
|
-
|
|
|
|
2,445
|
|
Total operating costs and expenses
|
|
|
14,081
|
|
|
|
5,765
|
|
|
|
230,351
|
|
Loss from operations
|
|
|
(13,944
|
)
|
|
|
(5,765
|
)
|
|
|
(226,673
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Valuation of reclassified equity instruments
|
|
|
-
|
|
|
|
491
|
|
|
|
16,071
|
|
Conversion inducement expense
|
|
|
-
|
|
|
|
-
|
|
|
|
(27,337
|
)
|
Accretion of redeemable securities
|
|
|
-
|
|
|
|
-
|
|
|
|
(2,042
|
)
|
Derivative valuation gain (loss)
|
|
|
-
|
|
|
|
348
|
|
|
|
1,383
|
|
Gain on sale of intellectual property and property and equipment
|
|
|
-
|
|
|
|
-
|
|
|
|
3,664
|
|
Interest expense
|
|
|
(450
|
)
|
|
|
(5,225
|
)
|
|
|
(55,456
|
)
|
Interest income and other
|
|
|
-
|
|
|
|
-
|
|
|
|
1,707
|
|
Net loss
|
|
|
(14,394
|
)
|
|
|
(10,151
|
)
|
|
|
(288,683
|
)
|
Issuance of common stock in connection with elimination of Series A and Series A-1 preferred stock preferences
|
|
|
-
|
|
|
|
-
|
|
|
|
(12,349
|
)
|
Modification of Series A preferred stock warrants
|
|
|
-
|
|
|
|
-
|
|
|
|
(2,306
|
)
|
Modification of Series A-1 preferred stock warrants
|
|
|
-
|
|
|
|
-
|
|
|
|
(16,393
|
)
|
Series A preferred stock dividends
|
|
|
-
|
|
|
|
-
|
|
|
|
(334
|
)
|
Series A-1 preferred stock dividends
|
|
|
-
|
|
|
|
-
|
|
|
|
(917
|
)
|
Warrants issued on Series A and Series A-1 preferred stock dividends
|
|
|
-
|
|
|
|
-
|
|
|
|
(4,664
|
)
|
Accretion of Series A preferred stock mandatory redemption obligation
|
|
|
-
|
|
|
|
-
|
|
|
|
(1,872
|
)
|
Series A preferred stock redemption fee
|
|
|
-
|
|
|
|
-
|
|
|
|
(1,700
|
)
|
Beneficial conversion feature of Series D preferred stock
|
|
|
-
|
|
|
|
-
|
|
|
|
(4,274
|
)
|
Net loss applicable to common stockholders
|
|
$
|
(14,394
|
)
|
|
$
|
(10,151
|
)
|
|
$
|
(333,492
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share applicable to common stockholders - basic
|
|
$
|
(0.54
|
)
|
|
$
|
(1.06
|
)
|
|
|
|
|
Weighted average shares used in computing basic loss per share
|
|
|
26,710
|
|
|
|
9,599
|
|
|
|
|
|
See accompanying notes
to the consolidated financial statements
NORTHWEST BIOTHERAPEUTICS, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF COMPREHENSIVE
LOSS
(in thousands)
(Unaudited)
|
|
Three Months Ended March 31,
|
|
|
Period from
Inception (March
18, 1996) to
|
|
|
|
2013
|
|
|
2012
|
|
|
March 31, 2013
|
|
Net loss
|
|
$
|
(14,394
|
)
|
|
$
|
(10,151
|
)
|
|
$
|
(288,683
|
)
|
Other comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment
|
|
|
-
|
|
|
|
(40
|
)
|
|
|
(190
|
)
|
Total comprehensive loss
|
|
$
|
(14,394
|
)
|
|
$
|
(10,191
|
)
|
|
$
|
(288,873
|
)
|
See accompanying notes to the consolidated
financial statements
NORTHWEST BIOTHERAPEUTICS, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CHANGE IN
STOCKHOLDERS’ EQUITY
(in thousands)
(Unaudited)
|
|
Three Months Ended
|
|
|
Period from
Inception (March
18, 1996) to
|
|
|
|
March 31, 2013
|
|
|
March 31, 2013
|
|
Common stock:
|
|
|
|
|
|
|
|
|
Balance, beginning of the period
|
|
$
|
27
|
|
|
$
|
-
|
|
Conversion of common stock at par related to reverse stock splits
|
|
|
-
|
|
|
|
(201
|
)
|
Conversion of notes payable due to management to common stock
|
|
|
-
|
|
|
|
5
|
|
Conversion of Series A and A-1 preferred stock into common stock
|
|
|
-
|
|
|
|
25
|
|
Exercise of stock options and warrants
|
|
|
-
|
|
|
|
5
|
|
Loan conversion and conversion inducement
|
|
|
-
|
|
|
|
91
|
|
Stock and warrants issued for cash
|
|
|
-
|
|
|
|
80
|
|
Stock and warrants issued for preferred stock conversion
|
|
|
-
|
|
|
|
7
|
|
Stock and warrants issued for services
|
|
|
-
|
|
|
|
15
|
|
Balance, end of the period
|
|
$
|
27
|
|
|
$
|
27
|
|
|
|
|
|
|
|
|
|
|
Additional paid-in capital:
|
|
|
|
|
|
|
|
|
Balance, beginning of the period
|
|
$
|
303,188
|
|
|
$
|
-
|
|
Adjustment of par value related to reverse stock splits
|
|
|
-
|
|
|
|
201
|
|
Amortization of deferred compensation, net
|
|
|
-
|
|
|
|
1,779
|
|
Beneficial conversion feature of Series D preferred stock
|
|
|
-
|
|
|
|
4,274
|
|
Beneficial conversion feature remeasurement
|
|
|
-
|
|
|
|
1,198
|
|
Cancellation of employee restricted stock grants
|
|
|
-
|
|
|
|
(412
|
)
|
Cancellation of employee stock options
|
|
|
-
|
|
|
|
(437
|
)
|
Change in warrant liability
|
|
|
-
|
|
|
|
4,863
|
|
Common stock - ESOP
|
|
|
-
|
|
|
|
6
|
|
Common stock warrant liability
|
|
|
-
|
|
|
|
(7,127
|
)
|
Conversion of notes payable due to management to common stock
|
|
|
-
|
|
|
|
266
|
|
Conversion of notes payable due to Toucan Capital to Series A-1 preferred stock
|
|
|
-
|
|
|
|
7,702
|
|
Conversion of Series A and A-1 preferred stock into common stock
|
|
|
-
|
|
|
|
31,592
|
|
Debt discount related to beneficial conversion and warrants
|
|
|
-
|
|
|
|
21,972
|
|
Exercise of stock options and warrants
|
|
|
-
|
|
|
|
436
|
|
Loan conversion and conversion inducement
|
|
|
934
|
|
|
|
70,799
|
|
Reclassification of embedded derviatives liability
|
|
|
-
|
|
|
|
900
|
|
Re-classification of equity instruments, net
|
|
|
-
|
|
|
|
(9,311
|
)
|
Revaluation of preferred stock and warrants
|
|
|
-
|
|
|
|
18,699
|
|
Common stock offering costs
|
|
|
(10
|
)
|
|
|
(10
|
)
|
Stock and warrants issued for cash
|
|
|
-
|
|
|
|
84,923
|
|
Stock and warrants issued for accounts payable and accrued expenses
|
|
|
-
|
|
|
|
11,476
|
|
Stock and warrants issued for dividends
|
|
|
-
|
|
|
|
4,664
|
|
Stock and warrants issued for preferred stock conversion
|
|
|
-
|
|
|
|
12,342
|
|
Stock and warrants issued for services
|
|
|
883
|
|
|
|
21,138
|
|
Stock compensation expense
|
|
|
609
|
|
|
|
23,671
|
|
Balance, end of the period
|
|
$
|
305,604
|
|
|
$
|
305,604
|
|
|
|
|
|
|
|
|
|
|
Deficit accumulated during development stage:
|
|
|
|
|
|
|
|
|
Balance, beginning of the period
|
|
$
|
(319,098
|
)
|
|
$
|
-
|
|
Net loss
|
|
|
(14,394
|
)
|
|
|
(333,492
|
)
|
Balance, end of the period
|
|
$
|
(333,492
|
)
|
|
$
|
(333,492
|
)
|
|
|
|
|
|
|
|
|
|
Cumulative translation adjustment:
|
|
|
|
|
|
|
|
|
Balance, beginning of the period
|
|
$
|
(190
|
)
|
|
$
|
-
|
|
Foreign currency translation adjustment
|
|
|
-
|
|
|
|
(190
|
)
|
Balance, end of the period
|
|
$
|
(190
|
)
|
|
$
|
(190
|
)
|
|
|
|
|
|
|
|
|
|
Total stockholders' deficit:
|
|
$
|
(28,051
|
)
|
|
$
|
16,073
|
|
See accompanying notes to the consolidated
financial statements
NORTHWEST BIOTHERAPEUTICS, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(Unaudited)
|
|
Three Months Ended March 31,
|
|
|
Period from
Inception (March
18, 1996) to
|
|
|
|
2013
|
|
|
2012
|
|
|
March 31, 2013
|
|
Cash Flows from Operating Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss
|
|
$
|
(14,394
|
)
|
|
$
|
(10,151
|
)
|
|
$
|
(288,683
|
)
|
Reconciliation of net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
3
|
|
|
|
2
|
|
|
|
2,380
|
|
Amortization of deferred financing costs
|
|
|
-
|
|
|
|
-
|
|
|
|
320
|
|
Amortization of debt discount and accretion on redeemable securities
|
|
|
368
|
|
|
|
4,634
|
|
|
|
44,613
|
|
Derivative valuation gain
|
|
|
-
|
|
|
|
(348
|
)
|
|
|
(1,383
|
)
|
Accrued interest converted to stock
|
|
|
-
|
|
|
|
-
|
|
|
|
260
|
|
Accreted interest on convertible promissory note
|
|
|
-
|
|
|
|
-
|
|
|
|
1,484
|
|
Stock-based compensation costs
|
|
|
609
|
|
|
|
1,042
|
|
|
|
23,671
|
|
Stock and warrants issued for services and other expenses
|
|
|
883
|
|
|
|
-
|
|
|
|
24,837
|
|
Loan and accounts payable conversion inducement
|
|
|
-
|
|
|
|
-
|
|
|
|
19,518
|
|
Valuation of reclassified equity contracts
|
|
|
-
|
|
|
|
(491
|
)
|
|
|
(16,070
|
)
|
Asset impairment loss and gain on sale of properties
|
|
|
-
|
|
|
|
-
|
|
|
|
(936
|
)
|
Loss on facility sublease
|
|
|
-
|
|
|
|
-
|
|
|
|
895
|
|
Increase (decrease) in cash resulting from changes in assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets
|
|
|
73
|
|
|
|
(3
|
)
|
|
|
671
|
|
Accounts payable and accrued expenses
|
|
|
299
|
|
|
|
2,027
|
|
|
|
8,022
|
|
Related party accounts payable and accrued expenses
|
|
|
5,085
|
|
|
|
(253
|
)
|
|
|
33,229
|
|
Deposits and other non-current assets
|
|
|
-
|
|
|
|
-
|
|
|
|
(1
|
)
|
Accrued loss on sublease
|
|
|
-
|
|
|
|
-
|
|
|
|
(265
|
)
|
Deferred rent
|
|
|
-
|
|
|
|
-
|
|
|
|
410
|
|
Net Cash used in Operating Activities
|
|
|
(7,074
|
)
|
|
|
(3,541
|
)
|
|
|
(147,029
|
)
|
Cash Flows from Investing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment, net
|
|
|
-
|
|
|
|
-
|
|
|
|
(5,124
|
)
|
Proceeds from sale of property and equipment
|
|
|
-
|
|
|
|
-
|
|
|
|
258
|
|
Proceeds from sale of intellectual property
|
|
|
-
|
|
|
|
-
|
|
|
|
1,816
|
|
Proceeds from sale of marketable securities
|
|
|
-
|
|
|
|
-
|
|
|
|
2,000
|
|
Refund of security deposit
|
|
|
-
|
|
|
|
-
|
|
|
|
(3
|
)
|
Transfer of restricted cash
|
|
|
-
|
|
|
|
-
|
|
|
|
(1,035
|
)
|
Net Cash used in Investing Activities
|
|
|
-
|
|
|
|
-
|
|
|
|
(2,088
|
)
|
Cash Flows from Financing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of redeemable securities
|
|
|
-
|
|
|
|
-
|
|
|
|
5,302
|
|
Proceeds from issuance of notes payable
|
|
|
400
|
|
|
|
500
|
|
|
|
8,380
|
|
Proceeds from issuance of convertible notes payable
|
|
|
-
|
|
|
|
2,955
|
|
|
|
38,414
|
|
Proceeds from issuance of notes payable to related parties
|
|
|
-
|
|
|
|
-
|
|
|
|
11,250
|
|
Repayment of note payable to related parties
|
|
|
-
|
|
|
|
-
|
|
|
|
(8,050
|
)
|
Repayment of convertible promissory note
|
|
|
-
|
|
|
|
-
|
|
|
|
(3,262
|
)
|
Borrowing under line of credit, Northwest Hospital
|
|
|
-
|
|
|
|
-
|
|
|
|
2,834
|
|
Repayment of line of credit, Northwest Hospital
|
|
|
-
|
|
|
|
-
|
|
|
|
(2,834
|
)
|
Payment on capital lease obligations
|
|
|
-
|
|
|
|
-
|
|
|
|
(323
|
)
|
Payments on note payable
|
|
|
(289
|
)
|
|
|
-
|
|
|
|
(709
|
)
|
Proceeds from issuance preferred stock, net
|
|
|
-
|
|
|
|
-
|
|
|
|
28,708
|
|
Proceeds from exercise of stock options and warrants
|
|
|
-
|
|
|
|
-
|
|
|
|
228
|
|
Proceeds from issuance common stock, net
|
|
|
-
|
|
|
|
139
|
|
|
|
72,932
|
|
Proceeds from sale of stock warrant
|
|
|
-
|
|
|
|
-
|
|
|
|
90
|
|
Payment of preferred stock dividends
|
|
|
-
|
|
|
|
-
|
|
|
|
(1,251
|
)
|
Series A preferred stock redemption fee
|
|
|
-
|
|
|
|
-
|
|
|
|
(1,700
|
)
|
Deferred financing costs
|
|
|
(10
|
)
|
|
|
-
|
|
|
|
(330
|
)
|
Net Cash provided by Financing Activities
|
|
|
101
|
|
|
|
3,594
|
|
|
|
149,679
|
|
Effect of exchange rates on cash and cash equivalents
|
|
|
-
|
|
|
|
(40
|
)
|
|
|
(190
|
)
|
Net increase (decrease) in cash and cash equivalents
|
|
|
(6,973
|
)
|
|
|
13
|
|
|
|
373
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period
|
|
|
7,346
|
|
|
|
24
|
|
|
|
-
|
|
Cash and cash equivalent at end of period
|
|
$
|
373
|
|
|
$
|
37
|
|
|
$
|
373
|
|
See accompanying notes to the consolidated
financial statements
NORTHWEST BIOTHERAPEUTICS, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
|
|
Three Months Ended March 31,
|
|
|
Period from Inception
(March 18, 1996) to
|
|
|
|
2013
|
|
|
2012
|
|
|
March 31, 2013
|
|
Supplemental disclosure of cash flow information - Cash paid during the period for interest
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
1,879
|
|
Supplemental schedule of non-cash financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Equipment acquired through capital leases
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
285
|
|
Issuance of common stock in connection with elimination of Series A and Series A-1 preferred stock preferences
|
|
|
-
|
|
|
|
-
|
|
|
|
12,349
|
|
Issuance of common stock in connection with conversion of liabilities
|
|
|
934
|
|
|
|
3,738
|
|
|
|
60,116
|
|
Issuance of redeemable common stock in connection with conversion of liabilities
|
|
|
-
|
|
|
|
-
|
|
|
|
3,673
|
|
Warrants issued on Series A and Series A-1 preferred stock dividends
|
|
|
-
|
|
|
|
-
|
|
|
|
4,664
|
|
Liability for reclassified equity contracts
|
|
|
-
|
|
|
|
29,412
|
|
|
|
41,253
|
|
Accretion of mandatorily redeemable Series A preferred stock redemption obligation
|
|
|
-
|
|
|
|
-
|
|
|
|
1,872
|
|
Debt discount on promissory notes
|
|
|
-
|
|
|
|
3,213
|
|
|
|
27,414
|
|
Issuance of Series C preferred stock warrants in connection with lease agreement
|
|
|
-
|
|
|
|
-
|
|
|
|
43
|
|
Issuance of common stock to settle accounts payable
|
|
|
-
|
|
|
|
-
|
|
|
|
4
|
|
Liability for and issuance of common stock and warrants to Medarex
|
|
|
-
|
|
|
|
-
|
|
|
|
840
|
|
Issuance of common stock to landlord
|
|
|
-
|
|
|
|
-
|
|
|
|
35
|
|
Deferred compensation on issuance of stock options and restricted stock grants
|
|
|
-
|
|
|
|
-
|
|
|
|
759
|
|
Cancellation of options and restricted stock
|
|
|
-
|
|
|
|
-
|
|
|
|
849
|
|
Financing of prepaid insurance through note payable
|
|
|
-
|
|
|
|
-
|
|
|
|
491
|
|
Stock subscription receivable
|
|
|
-
|
|
|
|
-
|
|
|
|
480
|
|
Modification of Series A preferred stock warrants
|
|
|
-
|
|
|
|
-
|
|
|
|
2,306
|
|
Modification of Series A-1 preferred stock warrants
|
|
|
-
|
|
|
|
-
|
|
|
|
16,393
|
|
Conversion of convertible promissory notes and accrued interest to Series A-1 preferred stock
|
|
|
-
|
|
|
|
-
|
|
|
|
7,707
|
|
Conversion of convertible promissory notes and accrued interest to Series D preferred stock
|
|
|
-
|
|
|
|
-
|
|
|
|
5,324
|
|
Conversion of debt to accounts payable
|
|
|
-
|
|
|
|
-
|
|
|
|
1,428
|
|
Conversion of convertible promissory notes and accrued interest to stock
|
|
|
-
|
|
|
|
-
|
|
|
|
269
|
|
See accompanying notes to the consolidated
financial statements
1. Basis of Presentation
The accompanying unaudited consolidated
financial statements include the accounts of Northwest Biotherapeutics, Inc. and its subsidiaries, NW Bio Europe S.A.R.L. and NW
Bio GmBh (collectively, the “Company”, “we”, “us”, and “our”). All material intercompany
balances and transactions have been eliminated. The accompanying unaudited consolidated financial statements should be read in
conjunction with the financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2012. The
year-end balance sheet data was derived from audited financial statements, but does not include all disclosures required by accounting
principles generally accepted in the United States of America (“GAAP”). All normal recurring adjustments which are
necessary for the fair presentation of the results for the interim periods are reflected herein. Operating results for the three
month periods ended March 31, 2013 and 2012 are not necessarily indicative of results to be expected for a full year.
In April 2013, the Company entered
into an agreement with one healthcare-dedicated institutional investor for a registered direct placement of $10.0 million of
common stock at the closing market price of $3.90 per share. The number of shares of common stock issued was 2,564,103.
The Company issued to the investor warrants exercisable for 1,025,641 shares of common stock. The Company also issued to
the placement agent warrants exercisable for 128,205 shares of common stock. The warrants have an exercise price of $4.29
per share and are exercisable beginning six months after closing, with a term of five years. Net proceeds to the Company
amounted to $9.2 million after deducting deal related costs.
2.
Liquidity
and Going Concern
The Company has experienced recurring losses
from operations. Net cash outflows from operations were $7.1 million for the three months ended March 31, 2013. The Company
had a working capital deficit of $15.8 million at March 31, 2013 (excluding redeemable common stock amounting to $11.0 million).
The Company had a deficit accumulated during
the development stage of $333.5 million at March 31, 2013.
Since 2004, Toucan Capital Fund II, L.P.
(“Toucan Capital”), Toucan Partners LLC (“Toucan Partners”), entities controlled by Ms. Linda Powers, the
Company’s CEO and the managing director of Toucan Capital and managing member of Toucan Partners, and Ms. Linda Powers (collectively
“Toucan”) have provided substantial funding to the Company. From 2004 through March 31, 2013, Toucan provided ongoing
financings to the Company and through the purchase of common stock, preferred stock (which was all converted to common stock),
and debt securities. As of the date of this report, Toucan (other than Cognate BioServices) holds approximately 20% of common stock
outstanding as of March 31, 2013.
In addition to financing obtained from
Toucan and related entities, the Company has raised additional capital by issuing common stock and debt securities. As of March
31, 2013 the Company had approximately $0.4 million of cash and cash equivalents and had current liabilities of $16.2 million (of
which approximately half was owed to related parties and is expected to be converted into equity) and redeemable common stock of
$11.0
million. The Company will need to raise additional capital in the near future
to continue to fund its clinical trials and other operating activities and there can be no assurance that its efforts to seek such
funding will be successful. The Company may seek funding from Toucan Capital or Toucan Partners or their affiliates or other third
parties. Such parties are under no obligation to provide the Company with any additional funds, and any such funding may be dilutive
to stockholders and may contain restrictive covenants. There can be no assurance that the Company will be able to complete any
such financings or that the terms of such financings will be attractive to the Company. If the Company’s capital raising
efforts are unsuccessful, its inability to obtain additional cash as needed could have a material adverse effect on the Company’s
financial position, results of operations and the Company’s ability to continue its existence. On April 18, 2013, the Company
raised $9.2 million of new funding through the sale of common stock.
In October and November 2012, the Company
issued 1.9 million shares of redeemable common stock, at a purchase price of $4.80 per share to accredited investors (collectively,
the “Investors”) in separate private placement transactions and as part of conversions of debt into redeemable common
stock. Total cash received amounted to $5.3 million and total conversions of debt into redeemable common stock amounted to $4.6
million. These transactions were completed pursuant to a Securities Purchase Agreement (the “Agreement”) which the
Company entered into with each of the respective investor. The Agreements provide a one-time window during which such investors
can redeem the securities for cash at a premium to the original issuance ranging from 15% to 25%. The redemption windows occur
within 12 months from the date of issuance.
In order
to continue with the Company’s current activities under the DCVax®-L program, the Company will have to obtain substantial
amounts of further fundin
g, as described in the Risk Factors section in the Company’s annual
report on Form 10-K for the year ended December 31, 2012. The Company’s on-going funding requirements will depend on many
factors, including the extent to which the Company realizes and draws upon various sources of non-dilutive funding. One such source
of non-dilutive funding is a $5.5 million German grant awarded on May 1, 2012, by the German government through its Saxony Development
Bank. The grant will provide funding on matching basis for up to 50% of the costs incurred by the Company for the DCVax-L clinical
trial and manufacturing in Germany.
The Company anticipates beginning to draw upon the
grant in the next several months.
The independent registered public accounting
firm’s report on the financial statements for the fiscal year ended December 31, 2012 states that because of recurring operating
losses, net operating cash flow deficits, and a deficit accumulated during the development stage, there is substantial doubt about
the Company’s ability to continue as a going concern. A “going concern” opinion indicates that the financial
statements have been prepared assuming the Company will continue as a going concern and do not include any adjustments to reflect
the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities
that may result from the outcome of this uncertainty.
3. Stock-based Compensation
Compensation expense for all stock-based
awards is measured on the grant date based on the fair value of the award and is recognized as an expense, on a straight-line basis,
over the employee's requisite service period (generally the vesting period of the equity award). The fair value of each option
award is estimated on the grant date using a Black-Scholes option valuation model. Stock-based compensation expense is recognized
only for those awards that are expected to vest using an estimated forfeiture rate. We estimate pre-vesting option forfeitures
at the time of grant and reflect the impact of estimated pre-vesting option forfeitures in compensation expense recognized. For
options and warrants issued to non-employees, the Company recognizes stock compensation costs utilizing the fair value methodology
over the related period of benefit.
Stock-based compensation expense was as follows for the three
months ended March 31, 2013 and 2012 (in thousands):
|
|
Three Months Ended
March 31,
|
|
|
|
2013
|
|
|
2012
|
|
Research and development
|
|
$
|
30
|
|
|
$
|
158
|
|
General and administrative
|
|
|
579
|
|
|
|
884
|
|
Total stock- based compensation expense
|
|
$
|
609
|
|
|
$
|
1,042
|
|
There were no options to purchase common stock granted during
the three month ended March 31, 2013, although certain options previously granted were vested.
4.
|
Fair Value Measurements
|
Fair value is defined as the price that
would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the
measurement date. U.S. GAAP establishes a three tier fair value hierarchy which prioritizes the inputs used in measuring fair value.
The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level
1 inputs) and the lowest priority to unobservable inputs (Level 3 inputs). Level 1, 2, and 3 inputs are defined as follows:
·
|
Level 1 inputs are observable inputs such as quoted prices for identical instruments in active markets;
|
·
|
Level 2 inputs are inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and
|
·
|
Level 3 inputs are unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions, such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.
|
The Company's liability for reclassified
equity contracts was measured using significant unobservable (Level 3) inputs.
In 2011, as a result of the Company entering
into convertible promissory notes and issuing stock options and warrants to purchase common stock, the Company's total potential
outstanding common stock exceeded the Company’s authorized shares by approximately 6.8 million shares as of December 31,
2011. As a result, the Company was required to value a number of shares equal to the excess issuable on exercise of warrants and
options and on conversion of convertible notes and recognize the value as a liability. Effective February 6, 2012, the Company’s
stockholders approved an increase in the number of authorized shares sufficient to cover the excess. At that time, the liability
was re-measured, with changes in value included in other income (expense), and then reclassified to additional paid-in capital
(thereby removing it from the Company’s liabilities).
The Company concluded that certain conversion
features and warrant agreements included down-round provisions that were not indexed to the Company’s stock (and are therefore
recorded as derivative liabilities). The Company recognized the derivative liabilities at their respective fair values using a
binomial model adjusted for the probability of issuance using a Monte Carlo simulation. Changes in the fair value were recorded
in derivative valuation gain (loss) in the consolidated statements of operations. Key assumptions for determining fair values during
the periods presented included expected terms ranging from 3 to 15 months, volatility ranging from 95% to 190% and risk-free interest
rate of 0.18%.
The Company's embedded derivative liability
was measured using significant unobservable (Level 3) inputs. The following table represents the Company’s embedded derivative
liability activity (in thousands) for the three months ended March 31, 2013 and 2012:
|
|
Three Months Ended
March 31,
|
|
|
|
2013
|
|
|
2012
|
|
Beginning balance
|
|
$
|
-
|
|
|
$
|
601
|
|
Net change in fair value of embedded derivative liabilities
|
|
|
-
|
|
|
|
(348
|
)
|
Ending balance
|
|
$
|
-
|
|
|
$
|
253
|
|
The following table represents the activity
for the Company's liability for reclassified equity contracts (in thousands) for the three months ended March 31, 2013 and 2012:
|
|
Three Months Ended
March 31,
|
|
|
|
2013
|
|
|
2012
|
|
Beginning balance
|
|
$
|
-
|
|
|
$
|
29,903
|
|
Liabilities reclassified
|
|
|
-
|
|
|
|
693
|
|
Change in value of liabilities reclassified
|
|
|
-
|
|
|
|
(491
|
)
|
Liabilities reclassified to equity
|
|
|
-
|
|
|
|
(30,105
|
)
|
Ending balance
|
|
$
|
-
|
|
|
$
|
-
|
|
5. Notes Payable
The Company regularly issues notes and
the proceeds from the notes are used to finance operations. The notes may contain conversion features and may be issued along with
warrants to purchase common stock. For convertible notes, the Company allocates the proceeds received between convertible notes
payable and warrants on a relative fair value basis, if applicable. The resulting discount for warrants is amortized using the
effective interest method over the life of the debt instrument. After allocating a portion of the proceeds to the warrants, the
effective conversion price of the convertible note payable can be determined. If the effective conversion price is lower than the
market price of the Company's common stock on the date of issuance, a beneficial conversion feature is recorded as an additional
discount to the convertible notes payable. The beneficial conversion feature discount is also amortized using the effective interest
method over the life of the debt instrument. The amortization is recorded as interest expense on the consolidated statements of
operations. During the three months ended March 31, 2013 and March 31, 2012, the Company received proceeds from the issuance of
notes of $0.4 million and $3.5 million, respectively. The notes are payable on various dates through September 2014 and have interest
rates between 0% and 12%. During the three months ended March 31, 2013 and March 31, 2012, the Company recorded a debt discount
related to the beneficial conversion feature for convertible notes and detachable warrants of $0.0 million and $3.2 million, respectively.
The conversion prices of the notes, with fixed terms, range between $3.20 and $20.00. The beneficial conversion feature recorded
on the notes payable for the three months ended March 31, 2013 and 2012 was estimated based on the effective conversion price of
convertible notes after allocating debt proceeds between the note instruments and warrants on a relative fair value basis.
During the three months ended March 31,
2013, the Company converted notes payable of $0.9 million into approximately 0.4 million shares of common stock. During the three
months ended March 31, 2012 $3.7 million notes were converted into 0.6 million shares of common stock.
During the three months ended March 31, 2013, the Company repaid
$0.3 million of notes payable.
Notes payable consist of the following
at March 31, 2013 and December 31, 2012 (in thousands):
|
|
2013
|
|
|
2012
|
|
Notes payable - current
|
|
|
|
|
|
|
|
|
12% unsecured originally due July 2011 (net of
discount of $0 in 2013 and 2012)
|
|
$
|
934
|
|
|
$
|
934
|
|
|
|
|
934
|
|
|
|
934
|
|
Notes payable related parties - current
|
|
|
|
|
|
|
|
|
Demand notes (net of
discount of $0 in 2013 and 2012)
|
|
|
400
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Convertible notes payable, net - current
|
|
|
|
|
|
|
|
|
6% unsecured (net of
discount of $0 in 2013 and 2012)
|
|
|
410
|
|
|
|
435
|
|
8% unsecured due April 2013 (net of
discount of $0 in 2013 and 2012)
|
|
|
100
|
|
|
|
71
|
|
10% unsecured convertible note originally due November 2012 (net of
discount of $0 in 2013 and $4 in 2012)
|
|
|
207
|
|
|
|
500
|
|
|
|
|
717
|
|
|
|
1,006
|
|
Convertible Notes payable related party, net - current
|
|
|
|
|
|
|
|
|
6% due on demand (net of
discount of $0 in 2013 and 2012)
|
|
|
50
|
|
|
|
50
|
|
|
|
|
50
|
|
|
|
50
|
|
Long term convertible notes, net
|
|
|
|
|
|
|
|
|
0% unsecured
|
|
|
-
|
|
|
|
53
|
|
4% unsecured due September 2014 (net of
discount of $415 in 2012)
|
|
|
-
|
|
|
|
419
|
|
8% unsecured due 2014 (net of discount of $161 in 2013 and $114
in 2012)
|
|
|
1,316
|
|
|
|
1,410
|
|
|
|
|
1,316
|
|
|
|
1,882
|
|
Total notes payable, net
|
|
$
|
3,417
|
|
|
$
|
3,872
|
|
Principal amounting to $2.1 million is
payable during 2013 and $1.5 million is payable during 2014.
6. Net
Loss Per Share Applicable to Common Stockholders
Options, warrants, and convertible debt
outstanding were all considered anti-dilutive for the three months ended March 31, 2013, and 2012, due to net losses.
The following securities were not included
in the diluted net income (loss) per share calculation because their effect was anti-dilutive as of the periods presented (in thousands):
|
|
Three Months Ended
March 31,
|
|
|
|
2013
|
|
|
2012
|
|
Common stock options
|
|
|
1,551
|
|
|
|
1,573
|
|
Common stock warrants
|
|
|
12,214
|
|
|
|
4,202
|
|
Convertible notes
|
|
|
102
|
|
|
|
2,165
|
|
Excluded potentially dilutive securities
|
|
|
13,867
|
|
|
|
7,940
|
|
7. Related
Party Transactions
a.
Cognate
BioServices
In April, 2011, the
Company entered into a new service agreement with Cognate Bioservices, Inc. (“Cognate”), a contract manufacturing
and services organization in which Toucan Capital has a majority interest. In addition, two of the principals of Toucan
Capital are members of Cognate’s board of directors and Linda Powers who is a director of Cognate and managing director
of Toucan Capital is Chairperson of the Company’s Board of Directors and Chief Executive Officer of the Company. This
agreement replaces the agreement dated May 17, 2007 between the Company and Cognate, which had expired. Under the service
agreement, the Company agreed to continue to utilize Cognate’s services, for certain consulting and manufacturing
services to the Company for its ongoing DCVax®-Brain Phase III clinical trial. The scope of services is comparable to the
prior agreement, and the structure and process for payments are simplified. Under the terms of the current agreement the
Company pays Cognate a monthly facility fee and a fixed fee (in lieu of cost-plus charges) for each patient in the study,
subject to specified minimum number of patients per month, plus charges for certain patient and product data services if such
services are requested by the Company, and charges for the 2-year processes of technology transfer to third parties, training
of such parties’ personnel, drafting of Standard Operating procedures (SOPs) tailored to such third parties and,
collaboration to obtain regulatory approvals and certifications relating to the product and manufacturing. The current service agreement
will expire on March 31, 2016.
During the three months ended
March 31, 2013, at the Company’s request Cognate and third party sub-contractors carried out an intensive development program
relating to the DCVax-Direct product. The program proceeded on accelerated timetables in connection with the launch of the Company’s
Phase I/II clinical trial with DCVax-Direct for all solid tumor cancers. The development program included design, engineering,
sourcing, production, testing, modification and validation of the manufacturing automation equipment, disposables sets to be used
with the manufacturing automation equipment, manufacturing processes, product ingredients, product release assays, and other matters,
as well as development of Standard Operating Procedures (SOPs), batch production records, and other necessary materials.
During the three months ended
March 31, 2013 and 2012, the Company recognized approximately $5.5 million and $2.2 million, respectively, of research and development
costs related to these service agreements. As of March 31, 2013 and December 31 2012, the Company owed Cognate (including third
party sub-contract amounts) approximately $8.4 million and $1.8 million, respectively. It is anticipated that a majority of these
amounts will be paid in stock rather than in cash.
b.
Toucan
Capital and Toucan Partners
In March 2013, the Company received
a short-term loan of $0.2 million from Toucan. The repayment terms were not finalized as of the date of this report.
c.
Other
Related Parties
In March 2013, the Company received
a short-term loan of $0.2 million from an executive officer. The repayment terms were not finalized as of the date of this report.
8. Stockholders’
Deficit
a.
Common
Stock Issuances
Issuances of common stock during the three months
ended March 31, 2013 were as follows (shares and dollars in thousands):
|
|
Shares
issued
|
|
|
Purchase/
Conversion
Price
|
|
|
Fair Value/
Proceeds/ Debt
Conversion
|
|
Shares issued for consulting services
|
|
|
236
|
|
|
$
|
3.75
|
|
|
$
|
883
|
|
Conversion of notes payable
|
|
|
359
|
|
|
|
2.60
|
|
|
|
934
|
|
Total three months ended March 31, 2013
|
|
|
595
|
|
|
$
|
3.06
|
|
|
$
|
1,817
|
|
0.2 million shares of common stock were issued to existing
stockholders in connection with an agreement with the stockholders and a consultant. Under the arrangement the Company issued
0.2 million shares of restricted common stock and warrants to purchase 0.1 million share of common stock to the stockholders
in order to induce them to transfer otherwise unrestricted common stock to the consultant on the date the common shares were
issued. The shares of common stock were valued at the closing price of the Company’s common stock on the date issued
and amounted to $0.9 million. The fair value of the 0.1 million warrants, with an exercise price of $6.40, amounting to $0.1
million, was determined using the Black-Scholes Option Pricing Model with the following assumptions: risk free interest rate
- 0.04%, volatility - 65%, expected term - 5 years, expected dividend n/a.
b.
Stock
Purchase Warrants
Through March 31, 2013, the
Company has issued warrants to strategic partners, consultants and investors with exercise prices ranging from $2.40 to $51.84
and with terms ranging from three to five years. Each warrant is exercisable into one share of common stock. The following
is a summary of warrant activity for the three months ended March 31, 2013:
|
|
|
|
|
Weighted
|
|
|
|
Number of
|
|
|
Average Exercise
|
|
|
|
Warrants
|
|
|
Price
|
|
Outstanding as of December 31, 2012
|
|
|
12,086,501
|
|
|
$
|
6.81
|
|
Issued in 1
st
quarter of 2013
|
|
|
109,035
|
|
|
|
6.40
|
|
Expired in 1
st
quarter of 2013
|
|
|
(18,125
|
)
|
|
|
15.45
|
|
Outstanding as of March 31, 2013
|
|
|
12,177,411
|
|
|
$
|
6.82
|
|
9. Subsequent
Events
In April 2013, the Company entered
into an agreement with one healthcare-dedicated institutional investor for a registered direct placement of $10.0 million of
common stock at the closing market price of $3.90 per share. The number of shares of common stock issued was 2,564,103.
The Company issued to the investor warrants exercisable for 1,025,641 shares of common stock. The Company also issued to
the placement agent warrants exercisable for 128,205 shares of common stock. Net proceeds to the Company amounted to $9.2
million after deducting deal related costs. The warrants have an exercise price of $4.29 per share and are exercisable
beginning six months after closing, with a term of five years.
During April of 2013, the Company
converted $0.7 million of notes payable into 0.2 million shares and holders exercised 0.2 million warrants.
Item 2. Management’s Discussion
and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of
our financial condition and results of operations should be read in conjunction with our unaudited consolidated financial statements
and the notes to those statements included with this report. In addition to historical information, this report contains forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and
Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such forward-looking statements
are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected. The words
“believe,” “expect,” “intend,” “anticipate,” and similar expressions are used to
identify forward-looking statements, but some forward-looking statements are expressed differently. Many factors could affect our
actual results, including those factors described under “Risk Factors” in our Form 10-K for the year ended December
31, 2012. These factors, among others, could cause results to differ materially from those presently anticipated by us. You should
not place undue reliance on these forward-looking statements.
Overview
We are a development stage biotechnology
company focused on developing immunotherapy products to treat cancers more effectively than current treatments, without toxicities
of the kind associated with chemotherapies, and, through a proprietary batch manufacturing process, on a cost-effective affordable
basis initially in both the United States and Europe (the two largest medical markets in the world).
We have developed a platform technology,
DCVax, which uses activated dendritic cells to mobilize a patient's own immune system to attack their cancer. The DCVax technology
is expected to be applicable to most cancers, and is embodied in several distinct product lines. One of the product lines (DCVax-L)
is designed to cover all solid tumor cancers in which the tumors can be surgically removed. Another product line (DCVax-Direct)
is designed for all solid tumor cancers which are considered inoperable and cannot be surgically removed. The broad applicability
of DCVax to many cancers provides multiple opportunities for commercialization and partnering.
After more than a decade of pre-clinical
and clinical development, the DCVax technology has reached late stage development for two different cancers (brain and prostate),
with a Phase III clinical trial in glioblastoma multiforme, or GBM, brain cancer currently under way, and a Phase III clinical
trial in prostate cancer which was previously cleared to proceed by the U.S. Food and Drug Administration, or FDA, which we anticipate
will proceed when we secure a partner. We have also completed a small early stage trial in metastatic ovarian cancer, and we have
received clearance from the FDA for early stage trials in multiple other diverse cancers.
In the Phase I/II trials which formed the
foundation for reaching these Phase III trials, the clinical results with DCVax were striking. DCVax treatment delayed disease
progression and extended survival by years, rather than weeks or months as is typical with cancer drugs. In addition, DCVax was
non-toxic: no serious adverse events related to the treatment were seen. These clinical results (both the efficacy and the lack
of toxicity) are consistent with a large and growing body of scientific literature and clinical experience, relating to the underlying
biology involved.
As of March 31, 2013, our Phase III clinical
trial in GBM is being conducted at 44 sites across the United States. We are also in the process of adding further U.S. sites.
Preparations for the Phase III GBM trial
are also progressing in Europe. We have accelerated and strengthened our programs in Europe by partnering with large, prominent
institutions, including the Fraunhofer IZI Institute in Germany and Kings College Hospital in the U.K.
In the U.K., we received approval from
the Medicines and Healthcare Products Regulatory Authority or MHRA, on August 23, 2012, to proceed with our Phase III clinical
trial in GBM in the U.K. We have been working on manufacturing arrangements for the clinical trial in the U.K. with both Kings
College London and the Fraunhofer Institute, under the oversight and management of Cognate BioServices, to obtain the necessary
approvals from the German and U.K. authorities for DCVax products to be able to be manufactured in either Germany or the U.K. for
the clinical trial in the U.K. These approvals were completed in February 2013. Four major medical centers in the U.K. are preparing
to proceed with the trial.
We have also been working on preparations
for the clinical trial in Germany. On July 25, 2012, we announced that manufacturing certification has been received from the German
regulatory authorities for the clinical trial in Germany, which is the first step towards implementation of the Phase III trial
in Germany. We submitted the application to the German regulatory authority (the Paul Ehrlich Institute, or PEI) for approval of
the Phase III trial. As of March 31, 2013, 24 clinical centers are in varying stages of preparations as trial sites in Germany.
Also, in October, 2012, ten major hospital centers across Germany, including the key opinion leaders in brain cancer, all applied
to the German healthcare system for reimbursement of DCVax-L for brain cancer.
In parallel with these developments in
our Phase III brain cancer program, we have been making arrangements to launch our DCVax-Direct program. On September 20, 2012,
we announced that we were in late stage discussions with medical centers in the U.S. and Europe to proceed with an initial Phase
I/II clinical trial with DCVax-Direct for solid tumor cancers. In the following months, we initiated preparations and final development
work for manufacturing of the DCVax-Direct products for this clinical trial.
We also entered into collaborations with
premiere institutions for the DCVax-Direct trial, as we have done for the DCVax-L trial. On November 6, 2012, we announced that
we had entered into a Letter of Intent for such a collaboration with Sarah Cannon Research Institute, which specializes in oncology
and has a network of more than 700 physicians in the US and UK who see more than 75,000 new cancer patients per year.
During the quarter ended
March 31, 2013, we have continued and accelerated the manufacturing work and the preparations for launch of the Phase I/II clinical
trial with DCVax-Direct for solid tumor cancers. The trial is expected to be launched in the second quarter 2013. Target patients
for inclusion in the trial include patients with melanoma, pancreatic cancer, liver cancer and liver metastases from colon or other
cancers. As is standard with this type of trial, the DCVax-Direct trial will not be blinded, and the results will be visible as
the trial proceeds over the course of 2013. The primary objectives of this two-part trial are to evaluate safety, dose levels and
efficacy. The Part 1 stage of the trial involves dose escalation and confirmation. The Part 2 stage of the trial will focus on
efficacy. The primary measure of efficacy will be regression (i.e., shrinkage or elimination) of the inoperable tumors. Such regression
is a rapid endpoint: if it is going to occur, then it is anticipated to occur within a couple months of treatment.
Our DCVax immunotherapies
are based on a platform technology involving dendritic cells, the master cells of the immune system, and are designed to reinvigorate
and educate the immune system to attack cancers. The dendritic cells are able to mobilize all parts of the immune system, including
T cells, B cells and antibodies, natural killer cells and many others. Mobilizing the entire immune system provides a broader attack
on the cancer than mobilizing just a particular component, such as T cells alone, or a particular antibody alone. Likewise, our
DCVax technology is designed to attack the full set of biomarkers, or antigens on a patient’s cancer, rather than just a
particular selected target or several targets. Clinical experience indicates that when just one or a few biomarkers on a cancer
are targeted by a drug or other treatment, sooner or later the cancer usually develops a way around that drug, and the drug stops
working. We believe that mobilizing all agents of the immune system, and targeting all biomarkers on the patient’s cancer,
contributes to the effectiveness of DCVax.
We believe that the
market potential of this technology is particularly large because the DCVax products are expected to be applicable to most or all
solid tumor cancers. We believe that the market potential is also enhanced by our two-continent strategy. By conducting our Phase
III clinical trial in GBM on an international basis, with trial sites in both the United States and Europe, we believe we are positioned
to potentially apply for product approval in both markets.
Critical Accounting Policies and Estimates
Our discussion and
analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in
accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect
our reported amounts of assets, liabilities, revenues and expenses.
On an ongoing basis,
we evaluate our estimates and judgments, including those related to accrued expenses and stock-based compensation. We based our
estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the
results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts
of revenues and expenses that are not readily apparent from other sources. Actual results may differ from these estimates.
Our critical accounting
policies and significant estimates are detailed in our Annual Report on Form 10-K for the year ended December 31, 2012. Our critical
accounting policies and significant estimates have not changed substantially from those previously disclosed in our Annual Report
on Form 10-K for the year ended December 31, 2012.
Recent Accounting Pronouncements
Management does not
believe that any recently issued, but not yet effective, accounting standards if currently adopted would have a material effect
on the accompanying financial statements.
Results of Operations
Operating costs:
Operating costs and expenses consist primarily
of research and development expenses, including clinical trial expenses which increase when we are actively participating in clinical
trials (and are especially high when we are in an ongoing phase III trial, as we now are in the US, and when we are preparing to
launch two additional clinical trial programs, as we now are with our Phase III trial in the UK and our 60-patient Phase I/II trial
in the US with DCVax-Direct), and general and administrative expenses.
Our operating costs include the development
work relating to the DCVax-Direct product and its manufacturing, such as the design, engineering, sourcing, production, testing,
modification and validation of the manufacturing automation equipment, disposables sets to be used with the manufacturing automation
equipment, manufacturing processes, product ingredients, product release assays, and other matters, as well as development of Standard
Operating Procedures (SOPs), batch production records, and other necessary materials.
Our operating costs also include the costs
of preparations for the two clinical trial programs about to be launched in the UK (with DCVax-L for brain cancer) and in the US
(with DCVax-Direct for various solid tumor cancers). The preparation costs include upfront payments to the clinical trial sites
and the CROs managing the trials and other service providers, and expenses related to institutional approvals, training of medical
and other site personnel, trial supplies and other.
Research and development:
Discovery and preclinical research and
development expenses include scientific personnel-related salary and benefit expenses, costs of laboratory supplies used in our
internal research and development projects, travel, regulatory compliance, and expenditures for preclinical and clinical trial
operation and management when we are actively engaged in clinical trials.
Because we are a development stage company,
we do not allocate research and development costs on a project basis. We adopted this policy, in part, due to the unreasonable
cost burden associated with accounting at such a level of detail and our limited number of financial and personnel resources.
General and administrative:
General and administrative expenses include
administrative personnel related salary and benefit expenses, cost of facilities, insurance, travel, legal support, property and
equipment and amortization of stock options and warrants.
Three Months Ended March 31, 2013 and 2012
We recognized a net loss of $7.1 million
in cash outlays and $7.3 million in non-cash accounting charges (i.e. stock-based compensation, issuance of warrants and restricted
stock for services, debt discount charges etc.), for a combined (cash and non-cash) total net loss of $ 14.4 million for the three
months ended March 31, 2013 compared to a net loss of $10.2 million for the three months ended March 31, 2012.
Research and Development Expense.
Research
and development expense was a combined (cash and non-cash) total of $11.6 million for the three months ended March 31, 2013 compared
to $3.6 million for the three months ended March 31,2012. The increase was primarily attributable to the DCVax-Direct manufacturing
and product development work described above, and the preparation costs for the launch of two clinical trial programs, in the US
and UK, as described above, as well as expansion of the ongoing Phase III trial in the US, and increased manufacturing of DCVax®-L
for the Phase III trial.
As of March 31, 2013 we had 44 clinical
trial sites in operation in the U.S in our Phase III trial with DCVax-L, compared to 25 clinical trial sites at March 31, 2012.
At March 31, 2013, we also had substantially expanded other clinical trial related operations compared with March 31, 2012 including,
for example, extensive preparations for launch of the Phase III DCVax-L clinical trial in the UK as described above, and launch
of the Phase I/II DCVax-Direct trial in the US as described above, in addition to costs related to fully operational and approved
manufacturing in Germany, an established wholly owned German subsidiary with a CEO who is an industry veteran from the senior management
of big pharma, manufacturing activity in the U.K. and nearly 30 clinical trial sites in the U.K. and Germany in varying stages
of preparation.
General and Administrative Expense.
General and administrative expense included $1 million of cash expenses, and $1.5 million of non-cash charges (i.e. amortization
of previously issued stock based compensation and restricted stock and warrants issued for services), for a combined total of $2.5
million for the three months ended March 31, 2013 compared to $2.2 million for the three months ended March 31, 2012. The slight
increase in general and administrative expenses from the prior period is as a result of $0.9 million related to the issuance of
restricted stock and warrants for public relations and investor relation services, offset by a $0.4 million decrease in stock based
compensation expense.
Interest (Expense).
Interest expense
(including non-cash elements such as amortization of debt discount) decreased to $0.5 million for the three months ended March
31, 2013 from $5.2 million for the three months ended March 31, 2012. The decrease in interest expense is primarily related to
the retirement of $27.8 million in notes payable during 2012.
Liquidity and Capital Resources
We have experienced recurring losses from
operations. Net cash outflows from operations were $7.1 million for the three months ended March 31, 2013.
At March 31, 2013, cash and cash equivalents
totaled $0.4 million, compared to $7.3 million at December 31, 2012. Working capital was a deficit of $15.8 million at March 31,
2013, compared to a deficit of $3.3 million at December 31, 2012 (excluding redeemable common stock amounting to $11.0 million).
The working capital deficit increase as of March 31, 2013 as compared to December 31, 2012 is primarily related to a $5.1 million
increase in related party accounts payable for expansion manufacturing and development work relating to DCVax-Direct, including
the work by third party sub-contractors, and $7.1 million of cash used in operating activities.
Operating Activities
We used $7.1
million in cash for operating activities during the three months ended March 31, 2013. The increase in cash used in operating activities
was primarily attributable to the DCVax-Direct manufacturing and product development work described above,
the
preparations for launch of the Phase I/II clinical trial with DCVax-Direct for solid tumor cancers,
increased manufacturing of DCVax®-L for the ongoing Phase III brain cancer trial in the US, an increased number of clinical
trial sites open and recruiting across the United States in our ongoing Phase III brain cancer trial and the preparation costs
for the launch of two clinical trial programs: the 60-patient Phase I/II trial with DCVax-Direct in the U.S., and the Phase III trial
with DC-Vax-L for brain cancer in the UK, as described above.
As of March 31, 2013 we had 44 clinical
trial sites in operation in the U.S. in our Phase III trial with DCVax-L, compared to 25 clinical trial sites at March 31, 2012.
At March 31, 2013, we also had substantially expanded other clinical trial related operations compared with March 31, 2012 including,
for example, extensive preparations for launch of the Phase III DCVax-L clinical trial in the UK as described above, and launch
of the Phase I/II DCVax-Direct trial in the U.S. as described above, in addition to costs related to fully operational and approved
manufacturing in Germany, an established wholly owned German subsidiary with a CEO who is an industry veteran from the senior management
of big pharma, manufacturing activity in the U.K. and nearly 30 clinical trial sites in the U.K. and Germany in varying stages
of preparation.
Financing Activities
During the three months ended March 31,
2013, our financing activities consisted of proceeds from notes payable from related parties amounting to $0.4 million offset by
the repayment of $0.3 million of notes payable.
In April 2013, we entered into
an agreement with one healthcare-dedicated institutional investor for a registered direct placement of $10.0 million of common
stock at the closing market price of $3.90 per share. We issued to the investor warrants exercisable for 1,025,641
shares of common stock. The warrants have an exercise price of $4.29 per share and are exercisable beginning
six months after closing, with a term of five years.
In order
to continue with our current activities under our DCVax®-L program, we will have to obtain substantial amounts of further
funding, as described in the Risk Factors section in
our
annual report on Form 10-K for the year ended December 31, 2012
. Our on-going funding
requirements will depend on many factors, including the extent to which we realize and draw upon various sources of
non-dilutive funding. One such source of non-dilutive funding is a $5.5 million German grant awarded on May 1, 2012, by the
German government through its Saxony Development Bank. The grant will provide funding on matching basis for up to 50%
of the costs incurred by the Company for the DCVax-L clinical trial and manufacturing in Germany.
The Company
anticipates beginning to draw upon the grant in the next several months.
Other factors affecting our ongoing funding
requirements include the number of staff we employ, the number of sites and pace of patient enrollment in our Phase III brain cancer
trial, the pace and number of sites at which we execute our Phase I/II clinical trials with DCVax-Direct, the costs of further
development work relating to DCvax-Direct, the costs of expansion of manufacturing of both DCVax-L and DCVax-Direct, the cost of
establishing clinical studies and compassionate use/named patient programs in other countries, and unanticipated developments.
The extent of resources available to us will determine the pace at which we can move forward with both our DCVax-L program and
our DCVax-Direct program.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our management,
including our principal executive, financial and accounting officer, we conducted an evaluation of our disclosure controls and
procedures, as such term is defined under Rule 13a-15(e) promulgated under the Securities Exchange Act of 1934, as amended. Based
on this evaluation, our principal executive, financial and accounting officer concluded that, in light of certain material weaknesses
in our internal control over financial reporting described in our annual report on Form 10-K for the year ended December 31, 2012
, our disclosure controls and procedures were not effective to ensure that the information required to be disclosed by us in the
reports that we file or submit under the Securities Exchange Act of 1934 is accumulated and communicated to management, including
our chief executive officer, financial and accounting officer, to allow timely decisions regarding required disclosure, and that
such information is recorded, processed, summarized and reported within the time periods prescribed by the SEC
.
Changes in Internal Control over Financial Reporting
There has been no
change in our internal controls over financial reporting that occurred during the fiscal quarter ended March 31, 2013, that has
materially affected, or is reasonably expected to materially affect, our internal controls over financial reporting.
Part II - Other Information
Item 1. Legal Proceedings
From
time to time, we are involved in claims and suits that arise in the ordinary course of our business.
At
present, we are not involved in any suits.
Item 6. Exhibits
31.1
|
|
Certification of President (Principal Executive Officer and Principal Financial and Accounting Officer), Pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.1
|
|
Certification of President, Chief Executive Officer and Principal Financial and Accounting Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
thereunto duly authorized.
|
NORTHWEST BIOTHERAPEUTICS, INC
|
|
|
|
Dated: May 15, 2013
|
By:
|
/s/ Linda M. Powers
|
|
|
Name:
|
Linda M. Powers
|
|
|
Title:
|
President and Chief Executive Officer
|
|
|
|
Principal Executive Officer
|
|
|
|
Principal Financial and Accounting Officer
|