x
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the quarterly period ended: June 30,
2007
|
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 or Plan of Operation
|
14
|
Item
3.
|
Controls
and Procedures
|
27
|
PART
II. OTHER INFORMATION
|
||
Item
1.
|
Legal
Proceedings
|
28
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
28
|
Item
3.
|
Defaults
Upon Senior Securities
|
28
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
28
|
Item
5.
|
Other
Information
|
28
|
Item
6.
|
Exhibits
|
28
|
June
30,
|
|
December
31,
|
|
||||
|
|
2007
(unaudited)
|
|
2006
(audited)
|
|||
ASSETS
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and equivalents
|
$
|
19,287,399
|
$
|
9,938,428
|
|||
Restricted
cash
|
1,005,323
|
1,655,251
|
|||||
Prepaid
expenses and other current assets
|
203,310
|
294,995
|
|||||
Total
current assets
|
20,496,032
|
11,888,674
|
|||||
FIXED
ASSETS, NET
|
32,600
|
23,810
|
|||||
DEPOSITS
|
15,350
|
10,875
|
|||||
TOTAL
ASSETS
|
$
|
20,543,982
|
$
|
11,923,359
|
|||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable and accrued liabilities
|
$
|
2,565,699
|
$
|
1,088,041
|
|||
Accrued
compensation
|
125,791
|
225,384
|
|||||
Accrued
preferred stock dividends
|
225,000
|
—
|
|||||
Total
current liabilities
|
2,916,490
|
1,313,425
|
|||||
COMMITMENTS
AND CONTINGENCIES
|
|||||||
REDEEMABLE
PREFERRED STOCK:
|
|||||||
Series
B convertible preferred stock, $0.00001 par value; 400 shares designated;
300 shares issued and outstanding at June 30, 2007 (liquidation preference
$15,000,000)
|
9,918,666
|
—
|
|||||
STOCKHOLDERS’
EQUITY:
|
|||||||
Preferred
Stock, $0.00001 par value; 6,272 authorized: Series A 8% cumulative
convertible preferred stock; 3,264 shares issued and outstanding
at
December 31, 2006 (liquidation preference $3,264,000); Series C 8%
cumulative convertible preferred stock; 272 shares issued and outstanding
at June 30, 2007 (liquidation preference $3,264,000)
|
—
|
—
|
|||||
Common
stock, $0.00001 par value; 100,000,000 shares authorized; 39,235,272
shares issued and outstanding at June 30, 2007 and December 31, 2006
(See
Note 9)
|
392
|
392
|
|||||
Additional
paid-in capital
|
37,996,363
|
34,294,154
|
|||||
Accumulated
deficit
|
(30,287,929
|
) |
(23,684,612
|
)
|
|||
Total
stockholders’ equity
|
7,708,826
|
10,609,934
|
|||||
TOTAL
LIABILITIES, REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
|
$
|
20,543,982
|
$
|
11,923,359
|
Three
Months Ended June 30,
|
|
Six
Months Ended June 30,
|
|
||||||||||
|
|
2007
|
|
2006
|
|
2007
|
|
2006
|
|
||||
COSTS
AND EXPENSES:
|
|||||||||||||
Research
and development
|
$
|
3,800,324
|
$
|
1,128,496
|
$
|
5,709,730
|
$
|
1,791,807
|
|||||
General
and administrative
|
636,250
|
531,142
|
1,243,972
|
1,302,640
|
|||||||||
Total
costs and expenses
|
4,436,574
|
1,659,638
|
6,953,702
|
3,094,447
|
|||||||||
OTHER
INCOME:
|
|||||||||||||
Interest
income
|
213,427
|
200,784
|
347,385
|
280,006
|
|||||||||
Miscellaneous
|
1,500
|
1,500
|
3,000
|
3,000
|
|||||||||
Total
other income
|
214,927
|
202,284
|
350,385
|
283,006
|
|||||||||
NET
LOSS
|
(4,221,647
|
)
|
(1,457,354
|
)
|
(6,603,317
|
)
|
(2,811,441
|
)
|
|||||
PREFERRED
STOCK DIVIDENDS
|
(290,280
|
)
|
(66,560
|
)
|
(355,560
|
)
|
(130,560
|
)
|
|||||
PREFERRED
STOCK DEEMED DIVIDENDS
|
(9,003,083
|
)
|
—
|
(9,003,083
|
)
|
—
|
|||||||
NET
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
|
$
|
(13,515,010
|
)
|
$
|
(1,523,914
|
)
|
$
|
(15,961,960
|
)
|
$
|
(2,942,001
|
)
|
|
BASIC
AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON
SHARE
|
$
|
(0.34
|
)
|
$
|
(0.04
|
)
|
$
|
(0.41
|
)
|
$
|
(0.08
|
)
|
|
SHARES
USED IN COMPUTING BASIC AND DILUTED NET LOSS ATTRIBUTABLE TOCOMMON
STOCKHOLDERS PER COMMON SHARE
|
39,235,272
|
39,216,261
|
39,235,272
|
35,095,002
|
Six
Months Ended June 30,
|
|
||||||
|
|
2007
|
|
2006
|
|
||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(6,603,317
|
)
|
$
|
(2,811,441
|
)
|
|
Adjustments
to reconcile net loss to cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
6,424
|
4,451
|
|||||
Stock-based
compensation
|
323,384
|
340,279
|
|||||
Increase
(decrease) in:
|
|||||||
Prepaid
expenses and other current assets
|
91,685
|
154,980
|
|||||
Accounts
payable and accrued liabilities
|
1,477,658
|
321,248
|
|||||
Accrued
compensation
|
(99,593
|
)
|
97,025
|
||||
Cash
used in operating activities
|
(4,803,759
|
)
|
(1,893,458
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Purchases
of property and equipment
|
(15,214
|
)
|
(2,820
|
)
|
|||
Change
in restricted cash
|
649,928
|
(2,424
|
)
|
||||
Deferred
financing costs
|
—
|
24,612
|
|||||
Deposits
|
(4,475
|
)
|
—
|
||||
Cash
provided by investing activities
|
630,239
|
19,368
|
|||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Proceeds
from issuance of Series B convertible preferred stock, net
|
13,693,051
|
—
|
|||||
Proceeds
from issuance of common stock, net
|
—
|
13,846,774
|
|||||
Dividends
paid to preferred stockholders
|
(130,560
|
)
|
(130,560
|
)
|
|||
Payment
to preferred stockholders in connection with exchange of shares
(1)
|
(40,000
|
)
|
|||||
Proceeds
from exercise of stock option
|
—
|
750
|
|||||
Cash
provided by financing activities
|
13,522,491
|
13,716,964
|
|||||
INCREASE
IN CASH AND EQUIVALENTS
|
9,348,971
|
11,842,874
|
|||||
CASH
AND EQUIVALENTS AT BEGINNING OF YEAR
|
9,938,428
|
4,267,115
|
|||||
CASH
AND EQUIVALENTS AT END OF PERIOD
|
$
|
19,287,399
|
$
|
16,019,989
|
|||
SUPPLEMENTAL
DISCLOSURE OF NON-CASH ACTIVITIES
|
|||||||
Deemed
dividends on preferred stock
|
$
|
8,963,083
|
$
|
—
|
|||
Dividends
declared but not paid to preferred stockholders
|
$
|
225,000
|
$
|
—
|
|||
Issuance
of warrants to Series B preferred stockholders
|
$
|
3,774,385
|
$
|
—
|
|||
Issuance
of warrants to Series C preferred stockholders
|
$
|
1,138,698
|
$
|
—
|
|||
Issuance
of warrants to placement agents
|
$
|
768,621
|
$
|
—
|
|||
Common
stock issued for services
|
$
|
—
|
$
|
136,850
|
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
|
2000
Stock Option Plan
|
73,873
|
2006
Stock Incentive Plan
|
1,040,000
|
Options
issued outside of formalized plans
|
2,578,778
|
Warrants
(1)
|
28,973,047
|
Preferred
stock (1)
|
22,014,000
|
Total
shares reserved for future issuance
|
54,679,698
|
Three
months ended June 30,
|
|
Six
months ended June 30,
|
|
||||||||||
|
|
2007
|
|
2006
|
|
2007
|
|
2006
|
|
||||
Employee
and director stock option grants:
|
|||||||||||||
Research
and development
|
$
|
63,313
|
$
|
45,615
|
$
|
126,379
|
$
|
91,230
|
|||||
General
and administrative
|
41,819
|
15,111
|
83,461
|
30,222
|
|||||||||
105,132
|
60,726
|
209,840
|
121,452
|
||||||||||
Non-employee
consultants stock option grants and restricted stock
awards:
|
|||||||||||||
Research
and development
|
4,063
|
-
|
21,921
|
-
|
|||||||||
General
and administrative
|
51,643
|
52,035
|
91,623
|
218,827
|
|||||||||
55,706
|
52,035
|
113,544
|
218,827
|
||||||||||
Total
stock-based compensation
|
$
|
160,838
|
$
|
112,761
|
$
|
323,384
|
$
|
340,279
|
Three
Months Ended
June
30, 2007
|
|
Six
Months Ended
June
30, 2007
|
|||||
Volatility
|
80
|
%
|
80
|
%
|
|||
Weighted-average
volatility
|
80
|
%
|
80
|
%
|
|||
Risk-free
interest rate
|
4.59
|
%
|
4.63
|
%
|
|||
Expected
life (years)
|
5
|
5
|
|||||
Dividend
|
0
|
%
|
0
|
%
|
|||
Weighted-average
exercise price
|
$
|
1.27
|
$
|
1.04
|
|||
Weighted-average
grant-date fair value
|
$
|
0.85
|
$
|
0.70
|
|
Options
Outstanding |
|
Weighted
Average
Exercise
Price
|
|
Weighted
Average
Remaining
Contracted
Term
in
Years
|
|
Aggregate
Intrinsic
Value
|
||||||
Outstanding
at January 1, 2007
|
3,492,651
|
$
|
0.70
|
||||||||||
Options
granted
|
200,000
|
$
|
1.04
|
||||||||||
Outstanding
at June 30, 2007
|
3,692,651
|
$
|
0.72
|
8.0
|
$
|
1,773,777
|
|||||||
Exercisable
at June 30, 2007
|
2,682,649
|
$
|
0.56
|
7.5
|
$
|
1,773,777
|
|
Three
Months Ended June 30,
|
|
Six
Months Ended June 30,
|
|
|||||||||
|
|
2007
|
|
2006
|
|
2007
|
|
2006
|
|||||
Stock
options
|
3,692,651
|
2,652,651
|
3,692,951
|
2,652,651
|
|||||||||
Warrants
|
26,873,047
|
14,561,449
|
26,873,047
|
14,561,449
|
|||||||||
Conversion
of preferred stock
|
18,264,000
|
2,417,774
|
18,264,000
|
2,417,774
|
·
|
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.
|
Payments
Due by Period
|
|
|||||||||||||||
|
|
Total
|
|
0-12
Months
|
|
1
- 3 Years
|
|
3
- 5 Years
|
|
After
5
Years
|
||||||
Chemotherapy
purchase commitment
|
$
|
800,000
|
$
|
800,000
|
$
|
-
|
$
|
-
|
$
|
-
|
·
|
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 Process 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 satisfy financial or contractual obligations to
us;
|
·
|
fail
to adequately market our products;
|
·
|
cease
operations with little or no notice;
or
|
·
|
offer,
design, manufacture or promote competing
products.
|
·
|
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.
|
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
|
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
|
X
|
||||||||
3.2
|
Certificate
of Merger merging Common Horizons, Inc. with and into Novelos
Therapeutics, Inc. dated June 13, 2005
|
X
|
||||||||
3.3
|
Certificate
of Correction dated March 3, 2006
|
X
|
||||||||
3.4
|
Certificate
of Amendment to Amended and Restated Certificate of Incorporation
dated
July 16, 2007
|
X
|
||||||||
3.5
|
Certificate
of Designations of Series B convertible preferred stock
|
X
|
||||||||
3.6
|
Certificate
of Designations of Series C cumulative convertible preferred
stock
|
X
|
Incorporated
by Reference
|
||||||||||
Exhibit
No.
|
Description
|
Filed
with this
Form 10-QSB |
Form
|
Filing
Date
|
Exhibit
No.
|
3.7
|
By-Laws
|
8-K
|
June
17, 2005
|
2
|
||||||
4.1
|
Form
of Common Stock Purchase Warrant dated May 2, 2007 issued pursuant
to the
Securities Purchase Agreement dated April 12, 2007
|
10-QSB
|
May
8, 2007
|
4.1
|
||||||
4.2
|
Form
of Common Stock Purchase Warrant dated May 2, 2007 issued pursuant
to the
Agreement to Exchange and Consent dated May 2, 2007
|
10-QSB
|
May
8, 2007
|
4.2
|
||||||
10.1
|
Securities
Purchase Agreement dated April 12, 2007
|
10-QSB
|
May
8, 2007
|
10.1
|
||||||
10.2
|
Letter
Amendment dated May 2, 2007 to the Securities Purchase Agreement
|
10-QSB
|
May
8, 2007
|
10.2
|
||||||
10.3
|
Registration
Rights Agreement dated May 2, 2007
|
10-QSB
|
May
8, 2007
|
10.3
|
||||||
10.4
|
Placement
Agent Agreement with Rodman & Renshaw, LLC dated February 12,
2007
|
10-QSB
|
May
8, 2007
|
10.4
|
||||||
10.5
|
Agreement
to Exchange and Consent dated May 1, 2007
|
10-QSB
|
May
8, 2007
|
10.5
|
||||||
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:
August 10, 2007
|
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
|
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
|
X
|
||||||||
3.2
|
Certificate
of Merger merging Common Horizons, Inc. with and into Novelos
Therapeutics, Inc. dated June 13, 2005
|
X
|
||||||||
3.3
|
Certificate
of Correction dated March 3, 2006
|
X
|
||||||||
3.4
|
Certificate
of Amendment to Amended and Restated Certificate of Incorporation
dated
July 16, 2007
|
X
|
||||||||
3.5
|
Certificate
of Designations of Series B convertible preferred stock
|
X
|
||||||||
3.6
|
Certificate
of Designations of Series C cumulative convertible preferred
stock
|
X
|
||||||||
3.7
|
By-Laws
|
8-K
|
June
17, 2005
|
2
|
||||||
4.1
|
Form
of Common Stock Purchase Warrant dated May 2, 2007 issued pursuant
to the
Securities Purchase Agreement dated April 12, 2007
|
10-QSB
|
May
8, 2007
|
4.1
|
||||||
4.2
|
Form
of Common Stock Purchase Warrant dated May 2, 2007 issued pursuant
to the
Agreement to Exchange and Consent dated May 1, 2007
|
10-QSB
|
May
8, 2007
|
4.2
|
||||||
10.1
|
Securities
Purchase Agreement dated April 12, 2007
|
10-QSB
|
May
8, 2007
|
10.1
|
||||||
10.2
|
Letter
Amendment dated May 2, 2007 to the Securities Purchase Agreement
|
10-QSB
|
May
8, 2007
|
10.2
|
||||||
10.3
|
Registration
Rights Agreement dated May 2, 2007
|
10-QSB
|
May
8, 2007
|
10.3
|
||||||
10.4
|
Placement
Agent Agreement with Rodman & Renshaw, LLC dated February 12,
2007
|
10-QSB
|
May
8, 2007
|
10.4
|
||||||
10.5
|
Agreement
to Exchange and Consent dated May 1, 2007
|
10-QSB
|
May
8, 2007
|
10.5
|
Incorporated
by Reference
|
||||||||||
Exhibit
No.
|
Description
|
Filed
with this
Form
10-QSB
|
Form
|
Filing
Date
|
Exhibit
No.
|
|||||
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
|