x
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the quarterly period ended: March 31,
2008
|
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.)
|
Large
accelerated filer o
|
Accelerated
filer o
|
|
Non-accelerated
filer o
|
Smaller
reporting company x
|
Item
1.
|
Financial
Statements
|
3
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
16
|
Item
4.
|
Controls
and Procedures
|
19
|
PART
II. OTHER INFORMATION
|
||
Item
1.
|
Legal
Proceedings
|
20
|
Item
1A.
|
Risk
Factors
|
20
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
29
|
Item
3.
|
Defaults
Upon Senior Securities
|
29
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
29
|
Other
Information
|
29
|
|
Item
6.
|
Exhibits
|
29
|
March 31,
|
December 31,
|
||||||
2008
|
2007
|
||||||
(unaudited)
|
(audited)
|
||||||
ASSETS
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and equivalents
|
$
|
6,501,049
|
$
|
9,741,518
|
|||
Restricted
cash
|
—
|
1,184,702
|
|||||
Prepaid
expenses and other current assets
|
99,748
|
133,281
|
|||||
Deferred
financing costs
|
57,213
|
—
|
|||||
Total
current assets
|
6,658,010
|
11,059,501
|
|||||
FIXED
ASSETS, NET
|
41,589
|
32,809
|
|||||
DEPOSITS
|
15,350
|
15,350
|
|||||
TOTAL
ASSETS
|
$
|
6,714,949
|
$
|
11,107,660
|
|||
LIABILITIES
AND STOCKHOLDERS’ DEFICIENCY
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable and accrued liabilities
|
$
|
8,545,680
|
$
|
6,372,478
|
|||
Accrued
compensation
|
304,240
|
349,412
|
|||||
Accrued
dividends
|
740,280
|
337,500
|
|||||
Deferred
revenue – current
|
33,333
|
—
|
|||||
Total
current liabilities
|
9,623,533
|
7,059,390
|
|||||
DEFERRED
REVENUE – NONCURRENT
|
458,334
|
—
|
|||||
COMMITMENTS
AND CONTINGENCIES
|
|||||||
REDEEMABLE
PREFERRED STOCK:
|
|||||||
Series
B convertible preferred stock, $0.00001 par value; 400 shares designated;
300 shares issued and outstanding at March 31, 2008 and December
31, 2007
(liquidation preference $15,675,000 at March 31, 2008) (Note
2)
|
9,918,666
|
9,918,666
|
|||||
STOCKHOLDERS’
DEFICIENCY:
|
|||||||
Preferred
stock, $0.00001 par value; 7,000 shares authorized: Series C 8% cumulative
convertible preferred stock; 272 shares issued and outstanding at
March
31, 2008 and December 31, 2007 (liquidation preference $3,329,280
at March
31, 2008) (Note 2)
|
—
|
—
|
|||||
Common
stock, $0.00001 par value; 150,000,000 shares authorized; 39,360,272
shares issued and outstanding at March 31, 2008; 39,260,272 shares
issued
and outstanding at December 31, 2007
|
393
|
392
|
|||||
Additional
paid-in capital
|
37,056,867
|
37,370,959
|
|||||
Accumulated
deficit
|
(50,342,844
|
)
|
(43,241,747
|
)
|
|||
Total
stockholders’ deficiency
|
(13,285,584
|
)
|
(5,870,396
|
)
|
|||
TOTAL
LIABILITIES, REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’
DEFICIENCY
|
$
|
6,714,949
|
$
|
11,107,660
|
Three Months Ended March 31,
|
|||||||
|
2008
|
2007
|
|||||
REVENUE
|
$
|
8,333
|
$
|
—
|
|||
COSTS
AND EXPENSES:
|
|||||||
Research
and development
|
6,911,925
|
1,909,407
|
|||||
General
and administrative
|
263,075
|
607,722
|
|||||
Total
costs and expenses
|
7,175,000
|
2,517,129
|
|||||
LOSS
FROM OPERATIONS
|
(7,166,667
|
)
|
(2,517,129
|
)
|
|||
OTHER
INCOME:
|
|||||||
Interest
income
|
63,321
|
133,959
|
|||||
Miscellaneous
|
2,249
|
1,500
|
|||||
Total
other income
|
65,570
|
135,459
|
|||||
NET
LOSS
|
(7,101,097
|
)
|
(2,381,670
|
)
|
|||
PREFERRED
STOCK DIVIDEND
|
(402,780
|
)
|
(65,280
|
)
|
|||
NET
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
|
$
|
(7,503,877
|
)
|
$
|
(2,446,950
|
)
|
|
BASIC
AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON
SHARE
|
$
|
(0.19
|
)
|
$
|
(0.06
|
)
|
|
SHARES
USED IN COMPUTING BASIC AND DILUTED
NET LOSS ATTRIBUTABLE TO COMMON
STOCKHOLDERS PER COMMON SHARE
|
39,342,494
|
39,235,272
|
Three Months Ended March 31,
|
|||||||
2008
|
2007
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(7,101,097
|
)
|
$
|
(2,381,670
|
)
|
|
Adjustments
to reconcile net loss to cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
3,491
|
3,878
|
|||||
Stock-based
compensation
|
87,689
|
162,546
|
|||||
Change
in:
|
|||||||
Prepaid
expenses and other current assets
|
33,533
|
101,740
|
|||||
Accounts
payable and accrued liabilities
|
2,173,202
|
157,100
|
|||||
Accrued
compensation
|
(45,172
|
)
|
(163,360
|
)
|
|||
Deferred
revenue
|
491,667
|
—
|
|||||
Cash
used in operating activities
|
(4,356,687
|
)
|
(2,119,766
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Purchases
of fixed assets
|
(12,271
|
)
|
(3,727
|
)
|
|||
Change
in restricted cash
|
1,184,702
|
47,540
|
|||||
Deferred
financing costs
|
(57,213
|
)
|
(25,000
|
)
|
|||
Cash
provided by investing activities
|
1,115,218
|
18,813
|
|||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Dividends
paid to preferred stockholders
|
—
|
(65,280
|
)
|
||||
Proceeds
from exercise of stock option
|
1,000
|
—
|
|||||
Cash
provided by (used in) financing activities
|
1,000
|
(65,280
|
)
|
||||
DECREASE
IN CASH AND EQUIVALENTS
|
(3,240,469
|
)
|
(2,166,233
|
)
|
|||
CASH
AND EQUIVALENTS AT BEGINNING OF YEAR
|
9,741,518
|
9,938,428
|
|||||
CASH
AND EQUIVALENTS AT END OF PERIOD
|
$
|
6,501,049
|
$
|
7,772,195
|
|||
SUPPLEMENTAL
DISCLOSURES OF NON-CASH FINANCING ACTIVITIES
|
|||||||
Dividends
accrued but not paid to preferred stockholders
|
$
|
402,780
|
$
|
—
|
Offering
|
Outstanding
(as adjusted)
|
Exercise
Price
(as adjusted)
|
Expiration Date
|
|||||||
2005
Bridge Loans
|
720,000
|
$
|
0.625
|
April
1, 2010
|
||||||
2005
PIPE:
|
||||||||||
Investors
|
4,500,000
|
$
|
1.00
|
August
9, 2008
|
||||||
Placement
agents and finders
|
680,000
|
$
|
1.00
|
August
9, 2010
|
||||||
Series
A Preferred (1):
|
||||||||||
Investors –
September 30, 2005 closing
|
909,090
|
$
|
1.00
|
September
30, 2010
|
||||||
Investors
– October 3, 2005 closing
|
60,606
|
$
|
1.00
|
October
3, 2010
|
||||||
2006
PIPE:
|
||||||||||
Investors
|
9,509,275
|
$
|
2.20
|
March
7, 2011
|
||||||
Placement
agents
|
760,743
|
$
|
2.20
|
March
7, 2011
|
||||||
Series
B Preferred:
|
||||||||||
Investors
|
7,500,000
|
$
|
1.25
|
May
2, 2012
|
||||||
Placement
agents
|
900,000
|
$
|
1.25
|
May
2, 2012
|
||||||
Series
C Exchange
|
1,333,333
|
$
|
1.25
|
May
2, 2012
|
||||||
Total
|
26,873,047
|
Three Months Ended
March 31,
|
|||||||
2008
|
2007
|
||||||
Employee
and director stock option grants:
|
|||||||
Research
and development
|
$
|
28,330
|
$
|
63,066
|
|||
General
and administrative
|
58,887
|
41,642
|
|||||
87,217
|
104,708
|
||||||
Non-employee
consultants stock option grants and restricted stock
awards:
|
|||||||
Research
and development
|
70
|
17,858
|
|||||
General
and administrative
|
402
|
39,980
|
|||||
472
|
57,838
|
||||||
Total
stock-based compensation
|
$
|
87,689
|
$
|
162,546
|
Three Months Ended
March 31,
|
|||||||
2008
|
2007
|
||||||
Volatility
|
80
|
%
|
80
|
%
|
|||
Weighted-average
volatility
|
80
|
%
|
80
|
%
|
|||
Risk-free
interest rate
|
3.28
|
%
|
4.66
|
%
|
|||
Expected
life (years)
|
5
|
5
|
|||||
Dividend
|
0
|
0
|
|||||
Weighted-average
exercise price
|
$
|
0.60
|
$
|
0.89
|
|||
Weighted-average
grant-date fair value
|
$
|
0.40
|
$
|
0.60
|
Options
Outstanding
|
Weighted
Average
Exercise Price
|
Weighted
Average Remaining
Contracted
Term in Years
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding at
January 1, 2008
|
4,847,651
|
$
|
0.67
|
||||||||||
Options
granted
|
335,000
|
$
|
0.60
|
||||||||||
Options
exercised
|
(100,000
|
)
|
$
|
0.01
|
|||||||||
Outstanding
at March 31, 2008
|
5,082,651
|
$
|
0.68
|
8.0
|
$
|
933,496
|
|||||||
Exercisable
at March 31, 2008
|
3,135,978
|
$
|
0.71
|
7.1
|
$
|
906,526
|
|
Three Months Ended
March 31,
|
||||||
|
2008
|
2007
|
|||||
Stock
options
|
5,082,651
|
3,612,651
|
|||||
Warrants
|
26,873,047
|
14,561,449
|
|||||
Conversion
of preferred stock
|
18,264,000
|
2,417,774
|
Prior to Series D Financing
|
Following Series D Financing
|
||||||||||||
Offering
|
Number
Outstanding
|
Exercise
Price
|
Number
Outstanding
|
Exercise
Price
|
|||||||||
2005
PIPE
|
5,180,000
|
$
|
1.00
|
7,969,181
|
$
|
0.65
|
|||||||
Series
A Preferred
|
969,696
|
$
|
1.00
|
969,696
|
$
|
0.65
|
|||||||
2006
PIPE
|
10,270,018
|
$
|
2.20
|
10,955,467
|
$
|
2.08
|
|||||||
Series
B Preferred
|
8,400,000
|
$
|
1.25
|
8,400,000
|
$
|
0.65
|
·
|
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.
|
·
|
the
number of potential products and technologies in
development;
|
·
|
continued
progress and cost of our 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 our
ability
to sell our drugs;
|
·
|
costs
involved in establishing manufacturing capabilities for clinical
trial and
commercial quantities of our drugs;
|
·
|
competing
technological and market
developments;
|
·
|
market
acceptance of our 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.
|
· |
demonstrating
benefit from delivery of each specific drug for specific medical
indications;
|
· |
demonstrating
through pre-clinical and clinical trials that each drug is safe and
effective; and
|
· |
demonstrating
that we have established a viable Good Manufacturing Practices capable
of
potential scale-up.
|
· |
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 we
are developing;
|
·
|
the
establishment and demonstration of the advantages, safety and efficacy
of
our technologies;
|
·
|
pricing
and reimbursement policies of government and third-party payers such
as
insurance companies, health maintenance organizations and other health
plan administrators;
|
·
|
our
ability to attract corporate partners, including pharmaceutical companies,
to assist in commercializing our intended products;
and
|
·
|
our
ability to market our products.
|
·
|
cease
selling, incorporating or using any of our technologies and/or products
that incorporate the challenged intellectual property, which would
adversely affect our 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
our products, which would be costly and
time-consuming.
|
· |
fail
to adequately market our products
|
·
|
fail
to satisfy financial or contractual obligations to
us;
|
·
|
offer,
design, manufacture or promote competing products ;
or
|
·
|
cease
operations with little or no
notice.
|
·
|
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 completion of other financing arrangements;
or
|
·
|
the
approval of certain mergers and other significant corporate transactions,
including a sale of substantially all of our assets, or merger with
a
publicly-traded shell or other company.
|
Filed
|
Incorporated
by Reference
|
|||||||||
Exhibit
No. |
Description
|
with
this
Form
10-Q
|
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
|
Amended
and Restated Certificate of Incorporation filed as Exhibit A to
the
Certificate of Merger merging Nove Acquisition, Inc. with and into
Novelos
Therapeutics, Inc. dated May 26, 2005
|
10-QSB
|
August
10, 2007
|
3.1
|
||||||
3.2
|
Certificate
of Merger merging Common Horizons, Inc. with and into Novelos
Therapeutics, Inc. dated June 13, 2005
|
10-QSB
|
August
10, 2007
|
3.2
|
||||||
3.3
|
Certificate
of Correction dated March 3, 2006
|
10-QSB
|
August
10, 2007
|
3.3
|
||||||
3.4
|
Certificate
of Amendment to Amended and Restated Certificate of Incorporation
dated
July 16, 2007
|
10-QSB
|
August
10, 2007
|
3.4
|
Filed
|
Incorporated
by Reference
|
|||||||||
Exhibit
No. |
Description
|
with
this
Form 10-Q |
Form
|
Filing
Date
|
Exhibit
No. |
|||||
3.5
|
Certificate
of Designations of Series B convertible preferred stock
|
10-QSB
|
August
10, 2007
|
3.5
|
||||||
3.6
|
Certificate
of Designations of Series C cumulative convertible preferred
stock
|
10-QSB
|
August
10, 2007
|
3.6
|
||||||
3.7
|
Certificate
of Designations of Series D convertible preferred stock
|
8-K
|
April
14, 2008
|
4.1
|
||||||
3.8
|
Certificate
of Elimination Series A 8% Cumulative Convertible Preferred Stock
of
Novelos Therapeutics, Inc.
|
8-K
|
April
14, 2008
|
4.2
|
||||||
3.9
|
By-Laws
|
8-K
|
June
17, 2005
|
2
|
||||||
10.1
|
Securities
Purchase Agreement dated March 26, 2008
|
8-K
|
April
14, 2008
|
10.1
|
||||||
10.2
|
Amendment
to Securities Purchase Agreement dated April 9, 2008
|
8-K
|
April
14, 2008
|
10.2
|
||||||
10.3
|
Registration
Rights Agreement dated April 11, 2008
|
8-K
|
April
14, 2008
|
10.3
|
||||||
10.4
|
Form
of Common Stock Purchase Warrant dated April 11, 2008 issued
pursuant to
the Securities Purchase Agreement dated March 26, 2008
|
8-K
|
April
14, 2008
|
4.3
|
||||||
10.5
|
Warrant
Amendment Agreement dated April 11, 2008
|
8-K
|
April
14, 2008
|
10.5
|
||||||
10.6
|
Amendment
to Registration Rights Agreement dated April 11, 2008
|
8-K
|
April
14, 2008
|
10.4
|
||||||
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
|
Certification
pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section
906 of
the Sarbanes-Oxley Act of 2002
|
X
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||||||||
NOVELOS
THERAPEUTICS, INC.
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||
Date:
May 14, 2008
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By:
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/s/
Harry S. Palmin
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Harry
S. Palmin
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||
President
and Chief Executive Officer
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Filed
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Incorporated
by Reference
|
|||||||||
Exhibit
No. |
Description
|
with
this
Form 10-Q |
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
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June
2, 2005
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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
|
Amended
and Restated Certificate of Incorporation filed as Exhibit A to
the
Certificate of Merger merging Nove Acquisition, Inc. with and into
Novelos
Therapeutics, Inc. dated May 26, 2005
|
10-QSB
|
August
10, 2007
|
3.1
|
||||||
3.2
|
Certificate
of Merger merging Common Horizons, Inc. with and into Novelos
Therapeutics, Inc. dated June 13, 2005
|
10-QSB
|
August
10, 2007
|
3.2
|
||||||
3.3
|
Certificate
of Correction dated March 3, 2006
|
10-QSB
|
August
10, 2007
|
3.3
|
||||||
3.4
|
Certificate
of Amendment to Amended and Restated Certificate of Incorporation
dated
July 16, 2007
|
10-QSB
|
August
10, 2007
|
3.4
|
||||||
3.5
|
Certificate
of Designations of Series B convertible preferred stock
|
10-QSB
|
August
10, 2007
|
3.5
|
||||||
3.6
|
Certificate
of Designations of Series C cumulative convertible preferred
stock
|
10-QSB
|
August
10, 2007
|
3.6
|
||||||
3.7
|
Certificate
of Designations of Series D convertible preferred
stock
|
8-K
|
April
14, 2008
|
4.1
|
||||||
3.8
|
Certificate
of Elimination of Series A 8% Cumulative Convertible Preferred
Stock of
Novelos Therapeutics, Inc.
|
8-K
|
April
14, 2008
|
4.2
|
||||||
3.9
|
By-Laws
|
8-K
|
June
17, 2005
|
2
|
||||||
10.1
|
Securities
Purchase Agreement dated March 26, 2008
|
8-K
|
April
14, 2008
|
10.1
|
||||||
10.2
|
Amendment
to Securities Purchase Agreement dated April 9, 2008
|
8-K
|
April
14, 2008
|
10.2
|
||||||
10.3
|
Registration
Rights Agreement dated April 11, 2008
|
8-K
|
April
14, 2008
|
10.3
|
||||||
10.4
|
Form
of Common Stock Purchase Warrant dated April 11, 2008 issued pursuant
to
the Securities Purchase Agreement dated March 26, 2008
|
8-K
|
April
14, 2008
|
4.3
|
||||||
10.5
|
Warrant
Amendment Agreement dated April 11, 2008
|
8-K
|
April
14, 2008
|
10.5
|
||||||
10.6
|
Amendment
to Registration Rights Agreement dated April 11, 2008
|
8-K
|
April
14, 2008
|
10.4
|
||||||
31.1
|
Certification
of the chief executive officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
X
|
||||||||
Filed
|
Incorporated
by Reference
|
|||||||||
Exhibit
No.
|
Description
|
with
this
Form
10-Q
|
Form
|
Filing
Date
|
Exhibit
No.
|
|||||
31.2
|
Certification
of the chief financial officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
X
|
||||||||
32.1
|
Certification
pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section
906 of
the Sarbanes-Oxley Act of 2002
|
X
|