x
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the quarterly period ended: September 30,
2006
|
o
|
TRANSITION
REPORT UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the transition period from ______________ to
______________
|
DELAWARE
|
04-3321804
|
|
(State
or other jurisdiction of
incorporation or organization) |
(IRS
Employer
Identification
No.)
|
PART I. FINANCIAL INFORMATION | ||||
Item 1. | Financial Statements | 3 | ||
Item 2. | Management’s Discussion and Analysis of Plan of Operation | 16 | ||
Item 3. | Controls and Procedures | 33 | ||
PART II. OTHER INFORMATION | ||||
Item 1. | Legal Proceedings | 34 | ||
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 34 | ||
Item 3. | Defaults Upon Senior Securities | 34 | ||
Item 4. | Submission of Matters to a Vote of Security Holders | 34 | ||
Item 5. | Other Information | 34 | ||
Item 6. | Exhibits | 35 |
September
30,
2006
|
December
31,
2005 |
||||||
|
(unaudited)
|
(audited)
|
|||||
ASSETS
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and equivalents
|
$
|
11,711,402
|
$
|
4,267,115
|
|||
Restricted
cash
|
2,210,768
|
196,908
|
|||||
Prepaid
expenses and other current assets
|
371,183
|
337,902
|
|||||
Total
current assets
|
14,293,353
|
4,801,925
|
|||||
PROPERTY
AND EQUIPMENT, NET
|
26,134
|
22,610
|
|||||
DEFERRED
FINANCING COSTS
|
—
|
24,612
|
|||||
PREPAID
EXPENSES
|
—
|
79,896
|
|||||
DEPOSITS
|
10,875
|
9,656
|
|||||
TOTAL
ASSETS
|
$
|
14,330,362
|
$
|
4,938,699
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable and accrued liabilities
|
$
|
1,102,067
|
$
|
211,456
|
|||
Accrued
interest
|
5,700
|
5,700
|
|||||
Total
current liabilities
|
1,107,767
|
217,156
|
|||||
COMMITMENTS
AND CONTINGENCIES
|
|||||||
STOCKHOLDERS'
EQUITY:
|
|||||||
Preferred
stock, $.00001 par value; 7,000 shares authorized:
|
|||||||
Series
A 8% cumulative convertible preferred stock; 3,264 shares issued
and
outstanding (liquidation preference $3,264,000)
|
—
|
—
|
|||||
Common
stock, $.00001 par value; 100,000,000 shares authorized; 39,235,272
and
27,921,199 shares issued and outstanding at September 30, 2006 and
December 31, 2005, respectively
|
392
|
279
|
|||||
Additional
paid-in capital
|
34,233,883
|
20,119,820
|
|||||
Accumulated
deficit
|
(21,011,680
|
)
|
(15,398,556
|
)
|
|||
Total
stockholders' equity
|
13,222,595
|
4,721,543
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
14,330,362
|
$
|
4,938,699
|
Three
Months Ended
September 30, |
Nine
Months Ended
September 30, |
|||||||||||||||
2006
|
2005
(Restated) |
2006
|
2005
(Restated) |
|||||||||||||
REVENUES:
|
||||||||||||||||
Sales
of samples
|
$
|
—
|
$
|
12,584
|
$
|
—
|
$
|
12,584
|
||||||||
Total
revenue
|
—
|
12,584
|
—
|
12,584
|
||||||||||||
COSTS
AND EXPENSES:
|
||||||||||||||||
Research
and development
|
2,408,658
|
376,461
|
4,200,465
|
927,169
|
||||||||||||
General
and administrative
|
586,542
|
596,863
|
1,889,182
|
905,224
|
||||||||||||
Total
costs and expenses
|
2,995,200
|
973,324
|
6,089,647
|
1,832,393
|
||||||||||||
OTHER
INCOME (EXPENSE):
|
||||||||||||||||
Interest
income
|
192,017
|
8,077
|
472,023
|
9,693
|
||||||||||||
Interest
expense
|
—
|
(3,209
|
)
|
—
|
(109,102
|
)
|
||||||||||
Miscellaneous
|
1,500
|
1,000
|
4,500
|
4,297
|
||||||||||||
Gain
on forgiveness of debt
|
—
|
—
|
—
|
2,087,531
|
||||||||||||
Restructuring
expense
|
—
|
—
|
—
|
(2,521,118
|
)
|
|||||||||||
Total
other income (expense)
|
193,517
|
5,868
|
476,523
|
(528,699
|
)
|
|||||||||||
NET
LOSS
|
(2,801,683
|
)
|
(954,872
|
)
|
(5,613,124
|
)
|
(2,348,508
|
)
|
||||||||
PREFERRED
STOCK DEEMED DIVIDEND
|
—
|
(1,943,377
|
)
|
—
|
(1,943,377 |
)
|
||||||||||
PREFERRED
STOCK DIVIDEND
|
(65,280
|
)
|
—
|
(195,840
|
)
|
—
|
||||||||||
NET
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
|
$
|
(2,866,963 |
)
|
$
|
(2,898,249
|
)
|
$
|
(5,808,964 |
)
|
$
|
(4,291,885 |
)
|
||||
BASIC
AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON
SHARE
|
$
|
(0.07
|
)
|
$
|
(0.11
|
)
|
$
|
(0.16
|
)
|
$
|
(0.22
|
)
|
||||
SHARES
USED IN COMPUTING BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON
STOCKHOLDERS PER COMMON SHARE
|
39,226,250
|
27,228,700
|
36,487,218
|
19,689,732
|
Nine
Months Ended
September
30,
|
|||||||
2006
|
2005
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(5,613,124
|
)
|
$
|
(2,348,508
|
)
|
|
Adjustments
to reconcile net loss to cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
7,192
|
1,303
|
|||||
Stock-based
compensation
|
462,492
|
168,186
|
|||||
Gain
on forgiveness of debt
|
—
|
(2,087,531
|
)
|
||||
Common
stock issued for restructuring expense
|
—
|
2,521,118
|
|||||
Increase
(decrease) in:
|
|||||||
Accounts
receivable
|
—
|
12,584
|
|||||
Prepaid
expenses and other current assets
|
46,615
|
(50,556
|
)
|
||||
Accounts
payable and accrued expenses
|
890,611
|
(40,325
|
)
|
||||
Accrued
interest
|
—
|
51,451
|
|||||
Deferred
revenue
|
—
|
(12,584
|
)
|
||||
Deferred
rent
|
—
|
250
|
|||||
Cash
used in operating activities
|
(4,206,214
|
)
|
(1,784,612
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Purchases
of property and equipment
|
(10,716
|
)
|
(22,963
|
)
|
|||
Change
in restricted cash
|
(2,013,860
|
)
|
(195,726
|
)
|
|||
Deferred
financing costs
|
24,612
|
—
|
|||||
Deposits
|
(1,219
|
)
|
(4,798
|
)
|
|||
Cash
used in investing activities
|
(2,001,183
|
)
|
(223,487
|
)
|
|||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Net
proceeds from issuance of preferred stock
|
—
|
2,680,000
|
|||||
Net
proceeds from issuance of common stock
|
13,846,774
|
3,819,034
|
|||||
Dividends
paid to preferred stockholders
|
(195,840
|
)
|
—
|
||||
Proceeds
from exercise of stock option
|
750
|
—
|
|||||
Payments
of long-term debt
|
—
|
(1,840
|
)
|
||||
Proceeds
from issuance of promissory notes
|
—
|
850,000
|
|||||
Payment
of promissory notes
|
—
|
(519,000
|
)
|
||||
Cash
provided by financing activities
|
13,651,684
|
6,828,194
|
|||||
INCREASE
IN CASH AND EQUIVALENTS
|
7,444,287
|
4,820,095
|
|||||
CASH
AND EQUIVALENTS, BEGINNING OF YEAR
|
4,267,115
|
10,356
|
|||||
CASH
AND EQUIVALENTS, END OF PERIOD
|
$
|
11,711,402
|
$
|
4,830,451
|
Nine
Months Ended
September
30,
|
|||||||
2006
|
2005
(Restated)
|
||||||
SUPPLEMENTAL
DISCLOSURES OF CASH FLOW INFORMATION
|
|||||||
Cash
paid for:
|
|||||||
Interest
|
$
|
—
|
$
|
57,461
|
|||
SUPPLEMENTAL
DISCLOSURES OF NON-CASH ACTIVITIES
|
|||||||
Common
stock issued for services
|
$
|
144,050
|
$
|
156,250
|
|||
Deemed
dividend for preferred stock conversion feature
|
$
|
—
|
$
|
1,943,377
|
|||
Common
stock issued for accrued services
|
$
|
—
|
$
|
216,000
|
|||
Common
stock issued on conversion of promissory notes
|
$
|
—
|
$
|
1,727,000
|
|||
Common
stock issued in exchange for accounts payable
|
$
|
—
|
$
|
544,221
|
|||
Common
stock issued for accrued interest
|
$
|
—
|
$
|
100,000
|
|||
Accounts
payable forgiven
|
$
|
—
|
$
|
773,599
|
|||
Accrued
compensation forgiven
|
$
|
—
|
$
|
360,357
|
|||
Accrued
interest forgiven
|
$
|
—
|
$
|
343,363
|
|||
Accrued
liability for amounts included in prepaid expenses
|
$
|
—
|
$
|
372,450
|
Three
Months
Ended September
30, 2006
|
Nine
Months
Ended
September
30, 2006
|
||||||
Employee
and director stock option grants:
|
|||||||
Research
and development
|
$
|
47,820
|
$
|
139,050
|
|||
General
and administrative
|
22,702
|
52,924
|
|||||
70,522
|
191,974
|
||||||
Non-employee
consultants stock option grants and
restricted
stock awards:
|
|||||||
Research
and development
|
3,969
|
3,969
|
|||||
General
and administrative
|
47,723
|
266,549
|
|||||
51,692
|
270,518
|
||||||
Total
stock-based compensation
|
$
|
122,214
|
$
|
462,492
|
|
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
|||||||||||
|
2006
|
2005
|
2006
|
2005
|
|||||||||
Volatility
|
80
|
%
|
80
|
%
|
80
|
%
|
0-80
|
%
|
|||||
Weighted-average
volatility
|
80
|
%
|
80
|
%
|
80
|
%
|
20.1
|
%
|
|||||
Risk-free
interest rate
|
4.59%-5.05
|
%
|
3.84%-4.30
|
%
|
4.59%-5.05
|
%
|
3.84%-4.81
|
%
|
|||||
Expected
life (years)
|
5-10
|
5-10
|
5-10
|
5-10
|
|||||||||
Dividend
|
0
|
0
|
0
|
0
|
|||||||||
Weighted-average
exercise price
|
$
|
1.23
|
$
|
3.22
|
$
|
1.23
|
$
|
0.66
|
|||||
Weighted-average
grant-date fair value
|
$
|
0.56
|
$
|
2.22
|
$
|
0.56
|
$
|
0.45
|
Three
Months Ended
September
30,
2005
|
Nine
Months Ended
September
30,
2005
|
||||||
Net
loss available to common stockholders as reported
|
$
|
(2,898,249
|
)
|
$
|
(4,291,885
|
)
|
|
Deduct:
Stock-based employee compensation expense
determined under fair value based method |
(45,915
|
)
|
(50,244
|
)
|
|||
Pro
forma net loss
|
$
|
(2,944,164
|
)
|
$
|
(4,342,129
|
)
|
|
Basic
and diluted net loss per share:
|
|||||||
As
reported
|
$
|
(0.11
|
)
|
$
|
(0.22
|
)
|
|
Pro
forma
|
$
|
(0.11
|
)
|
$
|
(0.22
|
)
|
|
Options
Outstanding
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contracted
Term in
Years
|
Aggregate
Intrinsic
Value
|
|||||||||
|
|
|
|
|
|||||||||
Outstanding
at December 31, 2005
|
2,727,651
|
$
|
0.60
|
8.9
|
$
|
4,294,257
|
|||||||
Granted
|
210,000
|
$
|
1.23
|
||||||||||
Exercised
|
(75,000
|
)
|
$
|
0.01
|
|||||||||
Outstanding
at September 30, 2006
|
2,862,651
|
$
|
0.66
|
8.3
|
$
|
1,836,718
|
|||||||
Exercisable
at September 30, 2006
|
2,230,312
|
$
|
0.41
|
8.1
|
$
|
1,700,076
|
Options
Outstanding
|
Options
Exercisable
|
|||||||||||||||
Exercise Price |
Number
of
Shares
|
Weighted
Average
Remaining
Contractual
Life
(Years)
|
Weighted
Average
Exercise
Price
|
Number
of
Shares
|
Weighted
Average
Exercise
Price
|
|||||||||||
$
0.01
|
2,053,778
|
8.1
|
$
|
0.01
|
1,900,627
|
$
|
0.01
|
|||||||||
$
0.70 - $1.95
|
255,705
|
9.2
|
$
|
1.14
|
51,517
|
$
|
0.88
|
|||||||||
$
2.00 - $3.22
|
525,000
|
8.9
|
$
|
2.63
|
250,000
|
$
|
2.65
|
|||||||||
$
7.01
|
28,168
|
5.8
|
$
|
7.01
|
28,168
|
$
|
7.01
|
|||||||||
2,862,651
|
8.30
|
$
|
0.66
|
2,230,312
|
$
|
0.41
|
|
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
|||||||||||
|
2006
|
2005
|
2006
|
2005
|
|||||||||
Stock
options
|
2,862,651
|
2,627,651
|
2,862,651
|
2,627,651
|
|||||||||
Warrants
|
14,561,449
|
4,768,402
|
14,561,449
|
4.768,402
|
|||||||||
Conversion
of preferred stock
|
2,417,774
|
1,818,182
|
2,417,774
|
1,818,182
|
Offering
|
Outstanding
(as
adjusted)
|
Exercise
Price
(as
adjusted)
|
Expiration
Date
|
|||||||
2005
Bridge Loans
|
720,000
|
$
|
0.625
|
April
1, 2010
|
||||||
2005
PIPE
|
||||||||||
Investors
|
3,333,275
|
$
|
1.35
|
August
9, 2008
|
||||||
Placement
Agents/Finders
|
503,692
|
$
|
1.35
|
August
9, 2010
|
||||||
Series
A Preferred
|
||||||||||
Investors
- September 30, 2005 closing
|
909,090
|
$
|
1.35
|
September
30, 2010
|
||||||
Investors
- October 3, 2005 closing
|
60,606
|
$
|
1.35
|
October
3, 2010
|
||||||
2006
PIPE
|
||||||||||
Investors
|
8,365,542
|
$
|
2.50
|
March
7, 2011
|
||||||
Placement
Agents
|
669,244
|
$
|
2.50
|
March
7, 2011
|
||||||
Total
|
14,561,449
|
· |
the
resources required to successfully complete our clinical trials;
|
· |
the
time and costs involved in obtaining regulatory approvals;
|
· |
continued
progress in our research and development programs, as well as the
magnitude of these programs;
|
· |
the
cost of manufacturing activities;
|
· |
the
costs involved in preparing, filing, prosecuting, maintaining, and
enforcing patent claims;
|
· |
the
timing, receipt, and amount of milestone and other payments, if any,
from
collaborators; and
|
· |
fluctuations
in foreign exchange rates.
|
· |
demonstrate
benefit from delivery of each specific drug for specific medical
indications;
|
· |
demonstrate
through pre-clinical and clinical trials that each drug is safe and
effective; and
|
· |
demonstrate
that the Company has established a viable Good Manufacturing Process
capable of potential scale-up.
|
· |
the
uncertainties arising from the rapidly growing scientific aspects
of drug
therapies and potential treatments;
|
· |
uncertainties
arising as a result of the broad array of alternative potential treatments
related to cancer, hepatitis and other diseases;
and
|
· |
anticipated
expense and time believed to be associated with the development and
regulatory approval of treatments for cancer, hepatitis and other
diseases.
|
· |
the
receipt of regulatory clearance of marketing claims for the uses
that the
Company is developing;
|
· |
the
establishment and demonstration of the advantages, safety and efficacy
of
the Company’s technologies;
|
· |
pricing
and reimbursement policies of government and third-party payers such
as
insurance companies, health maintenance organizations and other health
plan administrators;
|
· |
the
Company’s ability to attract corporate partners, including pharmaceutical
companies, to assist in commercializing the Company’s intended products;
and
|
· |
the
Company’s ability to market the Company’s
products.
|
· |
cease
selling, incorporating or using any of the Company’s technologies and/or
products that incorporate the challenged intellectual property, which
would adversely affect the Company’s future
revenue;
|
· |
obtain
a license from the holder of the infringed intellectual property
right,
which license may be costly or may not be available on reasonable
terms,
if at all; or
|
· |
redesign
the Company’s products, which would be costly and
time-consuming.
|
· |
fail
to satisfy financial or contractual obligations to the
Company;
|
· |
fail
to adequately market the Company’s
products;
|
· |
cease
operations with little or no notice;
or
|
· |
offer,
design, manufacture or promote competing
products.
|
· |
the
number of potential products and technologies in
development;
|
· |
continued
progress and cost of the Company’s research and development
programs;
|
· |
progress
with pre-clinical studies and clinical
trials;
|
· |
the
time and costs involved in obtaining regulatory
clearance;
|
· |
costs
involved in preparing, filing, prosecuting, maintaining and enforcing
patent claims;
|
· |
costs
of developing sales, marketing and distribution channels and the
Company’s
ability to sell the Company’s
drugs;
|
· |
costs
involved in establishing manufacturing capabilities for clinical
trial and
commercial quantities of the Company’s
drugs;
|
· |
competing
technological and market
developments;
|
· |
market
acceptance of the Company’s
products;
|
· |
costs
for recruiting and retaining management, employees and consultants;
|
· |
costs
for training physicians;
|
· |
our
status as a bulletin board listed company and the prospects for our
stock
to be listed on a national exchange;
and
|
· |
uncertainty
and economic instability resulting from terrorist acts and other
acts of
violence or war.
|
· |
the
election of directors;
|
· |
the
amendment of charter documents;
|
· |
issuance
of blank-check preferred or convertible stock, notes or instruments
of
indebtedness which may have conversion, liquidation and similar features,
or effecting other financing arrangements;
or
|
· |
the
approval of certain mergers and other significant corporate transactions,
including a sale of substantially all of the Company’s assets, or merger
with a publicly-traded shell or other company.
|
Nominee
|
|
Votes
For
|
|
Votes
Withheld
|
||
Simyon
Palmin
|
|
|
25,565,313
|
|
|
62,675
|
Harry
S. Palmin
|
|
|
25,565,113
|
|
|
62,875
|
Mark
Balazovsky
|
|
|
25,565,313
|
|
|
62,675
|
Michael
J. Doyle
|
25,565,313
|
|
|
62,675
|
||
Sim
Fass
|
25,565,313
|
|
|
62,675
|
||
David
B. McWilliams
|
|
|
25,565,313
|
|
|
62,675
|
Howard
M. Schneider
|
|
|
25,560,313
|
|
|
67,675
|
Incorporated
by Reference
|
||||||||||
Exhibit No. |
Description
|
Filed
with this
Form 10-QSB |
Form
|
Filing
Date
|
Exhibit
No.
|
|||||
2.1
|
Agreement
and plan of merger among Common Horizons, Inc., Nove Acquisition,
Inc. and
Novelos Therapeutics, Inc. dated May 26, 2005
|
8-K
|
June
2, 2005
|
99.2
|
||||||
2.2
|
Agreement
and plan of merger between Common Horizons and Novelos Therapeutics,
Inc.
dated June 7, 2005
|
10-QSB
|
August
15, 2005
|
2.2
|
||||||
3.1
|
Certificate
of Incorporation
|
8-K
|
June
17, 2005
|
1
|
||||||
3.2
|
Certificate
of Designations of Series A cumulative convertible preferred
stock
|
8-K
|
October
3, 2005
|
99.2
|
||||||
3.3
|
By-Laws
|
8-K
|
June
17, 2005
|
2
|
||||||
10.1
|
2006
Stock Incentive Plan
|
X
|
||||||||
31.1
|
Certification
of the chief executive officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
X
|
||||||||
31.2
|
Certification
of the chief financial officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
X
|
||||||||
32.1
|
Certificate
pursuant to 18 U.S.C. Section 1350 of the chief executive officer
|
X
|
||||||||
32.2
|
Certificate
pursuant to 18 U.S.C. Section 1350 of the chief financial
officer
|
X
|
NOVELOS THERAPEUTICS, INC. | ||
|
|
|
Date: November 6, 2006 | By: | /s/ Harry S. Palmin |
Harry S. Palmin |
||
President, Chief Executive Officer |
Incorporated
by Reference
|
||||||||||
Exhibit No. |
Description
|
Filed
with this
Form 10-QSB |
Form
|
Filing
Date
|
Exhibit
No.
|
|||||
2.1
|
Agreement
and plan of merger among Common Horizons, Inc., Nove Acquisition,
Inc. and
Novelos Therapeutics, Inc. dated May 26, 2005
|
8-K
|
June
2, 2005
|
99.2
|
||||||
2.2
|
Agreement
and plan of merger between Common Horizons and Novelos Therapeutics,
Inc.
dated June 7, 2005
|
10-QSB
|
August
15, 2005
|
2.2
|
||||||
3.1
|
Certificate
of Incorporation
|
8-K
|
June
17, 2005
|
1
|
||||||
3.2
|
Certificate
of Designations of Series A cumulative convertible preferred
stock
|
8-K
|
October
3, 2005
|
99.2
|
||||||
3.3
|
By-Laws
|
8-K
|
June
17, 2005
|
2
|
||||||
10.1
|
2006
Stock Incentive Plan
|
X
|
||||||||
31.1
|
Certification
of the chief executive officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
X
|
||||||||
31.2
|
Certification
of the chief financial officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
X
|
||||||||
32.1
|
Certificate
pursuant to 18 U.S.C. Section 1350 of the chief executive officer
|
X
|
||||||||
32.2
|
Certificate
pursuant to 18 U.S.C. Section 1350 of the chief financial
officer
|
X
|