x
|
ANNUAL REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
|
For
the Fiscal Year Ended: December 31,
2008
|
¨
|
TRANSITION REPORT PURSUANT TO
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
|
(I.R.S. Employer Identification
No.)
|
of incorporation or
organization)
|
|
One
Gateway Center, Suite 504
|
|
Newton,
Massachusetts 02458
|
|
(Address of principal executive
offices and zip code)
|
|
Title
of Class
|
Name
of each exchange on which registered
|
|
None
|
Not
Applicable
|
Large
accelerated filer o
|
|
Accelerated
filer ¨
|
|
Non-accelerated
filer o
|
|
Smaller
reporting company x
|
|
PART
I
|
|||
Item
1.
|
Business
|
2
|
|
Item
1A.
|
Risk
Factors
|
10
|
|
Item
2.
|
Properties
|
19
|
|
Item
3.
|
Legal
Proceedings
|
19
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
19
|
|
PART
II
|
|||
Item
5.
|
Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
|
19
|
|
Item
7.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
21
|
|
Item
8.
|
Financial
Statements
|
25
|
|
Item
9.
|
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
|
48
|
|
Item
9a.
|
Controls
and Procedures
|
49
|
|
Item
9b.
|
Other
Information
|
49
|
|
PART
III
|
|||
Item
10.
|
Directors,
Executive Officers and Corporate Governance
|
50
|
|
Item
11.
|
Executive
Compensation
|
52
|
|
Item
12.
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
57
|
|
Item
13.
|
Certain
Relationships and Related Transactions, and Director
Independence
|
59
|
|
Item
14.
|
Principal
Accountant Fees and Services
|
60
|
|
PART
IV
|
|||
Item
15.
|
Exhibits
|
61
|
|
·
|
Cell
signaling pathways
|
|
·
|
Cytoskeletal
structure/function
|
|
·
|
Protein
folding/stability
|
|
·
|
Calcium
homeostasis
|
|
·
|
Energy
metabolism
|
|
·
|
Redox
homeostasis
|
|
·
|
Group
A: NOV-002, administered intravenously and intramuscularly, in combination
with cytotoxic chemotherapy (carboplatin with
paclitaxel);
|
|
·
|
Group
B: NOV-002, administered intravenously and subcutaneously, in combination
with cytotoxic chemotherapy; and
|
|
·
|
Group
C: Cytotoxic chemotherapy alone was administered to this control
group.
|
|
·
|
Six
out of 13 (46%) patients in Group A demonstrated objective tumor
response;
|
|
·
|
11
out of 16 (69%) patients in Group B demonstrated objective tumor response;
and
|
|
·
|
five
out of 15 (33%) in Group C, the control group, demonstrated objective
tumor response.
|
|
·
|
Pre-clinical
laboratory tests, in
vivo pre-clinical studies, and formulation
studies;
|
|
·
|
The
submission to the FDA of an Investigational New Drug Application for human
clinical testing, which must become effective before human clinical trials
can commence;
|
|
·
|
Adequate
and well controlled human clinical trials to establish the safety and
efficacy of the product;
|
|
·
|
The
submission of a New Drug Application or Biologic Drug License Application
to the FDA; and
|
|
·
|
FDA
approval of the New Drug Application or Biologic Drug License Application
prior to any commercial sale or shipment of the
product.
|
|
·
|
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, including the results of
our Phase 3 clinical trial expected in late
2009;
|
|
·
|
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 educating physicians;
|
|
·
|
our
status as a Bulletin-Board listed company and the prospects for our stock
being listed on a national
exchange;
|
|
·
|
uncertainty
and economic instability resulting from terrorist acts and other acts of
violence or war; and
|
|
·
|
the
condition of capital markets and the economy generally, both in the U.S.
and globally.
|
|
·
|
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 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 ability to generate
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.
|
|
·
|
selling
or otherwise disposing of all or substantially all of our assets, (and in
the case of licensing any material intellectual property) or
entering into a merger or consolidation with another company unless we are
the surviving corporation, the Series E Preferred Stock remains
outstanding and there are no changes to the rights and preferences of the
Series E Preferred Stock;
|
·
|
redeeming
or repurchasing any capital stock other than Series E Preferred Stock;
or
|
·
|
incurring
any new debt for borrowed money in excess of
$500,000.
|
Fiscal
Year 2007
|
High
|
Low
|
||||||
First
quarter
|
$ | 1.24 | $ | 0.85 | ||||
Second
quarter
|
1.40 | 0.82 | ||||||
Third
quarter
|
0.90 | 0.45 | ||||||
Fourth
quarter
|
0.67 | 0.43 |
Fiscal
Year 2008
|
High
|
Low
|
||||||
First
Quarter
|
$ | 0.82 | $ | 0.43 | ||||
Second
Quarter
|
0.64 | 0.44 | ||||||
Third
Quarter
|
0.54 | 0.35 | ||||||
Fourth
Quarter
|
0.49 | 0.19 |
ITEM
8.
|
FINANCIAL
STATEMENTS
|
Page
|
||
Report
of Independent Registered Public Accounting Firm
|
26
|
|
Balance
Sheets at December 31, 2008 and 2007
|
27
|
|
Statements
of Operations for the Years Ended December 31, 2008 and
2007
|
28
|
|
Statements
of Redeemable Preferred Stock and Stockholders’ Deficiency for the Years
Ended December 31, 2008 and 2007
|
29
|
|
Statements
of Cash Flows for the Years Ended December 31, 2008 and
2007
|
30
|
|
Notes
to Financial Statements
|
31
|
December 31,
|
December 31,
|
|||||||
2008
|
2007
|
|||||||
ASSETS
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and equivalents
|
$ | 1,262,452 | $ | 9,741,518 | ||||
Restricted
cash
|
— | 1,184,702 | ||||||
Prepaid
expenses and other current assets
|
129,785 | 133,281 | ||||||
Total
current assets
|
1,392,237 | 11,059,501 | ||||||
FIXED
ASSETS, NET
|
58,451 | 32,809 | ||||||
DEPOSITS
|
15,350 | 15,350 | ||||||
TOTAL
ASSETS
|
$ | 1,466,038 | $ | 11,107,660 | ||||
LIABILITIES,
REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIENCY
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable and accrued liabilities
|
$ | 4,653,912 | $ | 6,372,478 | ||||
Accrued
compensation
|
240,639 | 349,412 | ||||||
Accrued
dividends
|
1,689,322 | 337,500 | ||||||
Deferred
revenue – current
|
33,333 | — | ||||||
Total
current liabilities
|
6,617,206 | 7,059,390 | ||||||
DEFERRED
REVENUE – NONCURRENT
|
433,333 | — | ||||||
COMMITMENTS AND
CONTINGENCIES
|
||||||||
REDEEMABLE PREFERRED STOCK: | ||||||||
Series
D convertible preferred stock, $0.00001 par value; 420 shares designated;
413.5 shares issued and outstanding at December 31, 2008 (liquidation
preference $22,070,562) (Note 4)
|
13,904,100 | — | ||||||
Series
B convertible preferred stock, $0.00001 par value; 400 shares designated;
300 shares issued and outstanding at December 31, 2007 (Note
4)
|
— | 9,918,666 | ||||||
13,904,100 | 9,918,666 | |||||||
STOCKHOLDERS’
DEFICIENCY:
|
||||||||
Preferred
stock, $0.00001 par value; Series C 8% cumulative convertible preferred
stock; 272 shares issued and outstanding at December 31, 2008 and 2007
(liquidation preference $3,557,760 and $3,264,000 at December 31, 2008 and
2007, respectively) (Note 4)
|
— | — | ||||||
Common
stock, $0.00001 par value; 150,000,000 shares authorized; 43,975,656
shares issued and outstanding at December 31, 2008; 39,260,272 shares
issued and outstanding at December 31, 2007
|
440 | 392 | ||||||
Additional
paid-in capital
|
40,204,112 | 37,370,959 | ||||||
Accumulated
deficit
|
(59,693,153 | ) | (43,241,747 | ) | ||||
Total
stockholders’ deficiency
|
(19,488,601 | ) | (5,870,396 | ) | ||||
TOTAL
LIABILITIES, REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’
DEFICIENCY
|
$ | 1,466,038 | $ | 11,107,660 |
Year Ended December 31,
|
||||||||
2008
|
2007
|
|||||||
REVENUE
|
$ | 125,968 | $ | — | ||||
COSTS
AND EXPENSES:
|
||||||||
Research
and development
|
14,526,619 | 17,427,804 | ||||||
General
and administrative
|
2,190,366 | 2,866,383 | ||||||
Total
costs and expenses
|
16,716,985 | 20,294,187 | ||||||
LOSS
FROM OPERATIONS
|
(16,591,017 | ) | (20,294,187 | ) | ||||
OTHER
INCOME:
|
||||||||
Interest
income
|
130,611 | 729,922 | ||||||
Miscellaneous
|
9,000 | 7,130 | ||||||
Total
other income
|
139,611 | 737,052 | ||||||
NET
LOSS
|
(16,451,406 | ) | (19,557,135 | ) | ||||
PREFERRED
STOCK DIVIDENDS
|
(2,092,102 | ) | (1,161,120 | ) | ||||
PREFERRED
STOCK DEEMED DIVIDENDS
|
(4,417,315 | ) | (9,003,083 | ) | ||||
NET
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
|
$ | (22,960,823 | ) | $ | (29,721,338 | ) | ||
BASIC
AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON
SHARE
|
$ | (0.56 | ) | $ | (0.76 | ) | ||
WEIGHTED
AVERAGE SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS ATTRIBUTABLE
TO COMMON STOCKHOLDERS PER COMMON SHARE
|
41,100,883 | 39,247,532 |
REDEEMABLE
PREFERRED STOCK
|
||||||||||||||||||||||||||||||||||||||||||||
Series B and D
Convertible Preferred
Stock
|
Common Stock
|
Series A Cumulative
Convertible
Preferred Stock
|
Series C Cumulative
Convertible
Preferred Stock
|
Additional
Paid-in
|
Accumulated
|
Total
Stockholders’
Equity
|
||||||||||||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Deficit
|
(Deficiency)
|
||||||||||||||||||||||||||||||||||
BALANCE
AT JANUARY 1, 2007
|
— | $ | — | 39,235,272 | $ | 392 | 3,264 | $ | — | — | $ | — | $ | 34,294,154 | $ | (23,684,612 | ) | $ | 10,609,934 | |||||||||||||||||||||||||
Exercise
of stock options
|
— | — | 25,000 | — | — | — | — | — | 250 | — | 250 | |||||||||||||||||||||||||||||||||
Compensation
expense associated with options issued to employees
|
— | — | — | — | — | — | — | — | 343,233 | — | 343,233 | |||||||||||||||||||||||||||||||||
Compensation
expense associated with options issued to non-employees
|
— | — | — | — | — | — | — | — | 160,057 | — | 160,057 | |||||||||||||||||||||||||||||||||
Issuance
of Series B redeemable convertible preferred stock and warrants, net of
issuance costs of $1,306,949
|
300 | 17,743,051 | — | — | — | — | — | — | 3,774,385 | — | 3,774,385 | |||||||||||||||||||||||||||||||||
Beneficial
conversion feature on Series B redeemable convertible preferred
stock
|
— | (7,824,385 | ) | — | — | — | — | — | — | 7,824,385 | — | 7,824,385 | ||||||||||||||||||||||||||||||||
Deemed
dividend related to the accretion of beneficial conversion feature on
Series B redeemable convertible preferred stock
|
— | — | — | — | — | — | — | — | (7,824,385 | ) | — | (7,824,385 | ) | |||||||||||||||||||||||||||||||
Retirement
of Series A preferred stock and issuance of Series C preferred
stock
|
— | — | — | — | (3,264 | ) | — | 272 | — | — | — | — | ||||||||||||||||||||||||||||||||
Issuance
of common stock purchase warrants in connection with exchange of preferred
stock
|
— | — | — | — | — | — | — | — | 1,138,698 | — | 1,138,698 | |||||||||||||||||||||||||||||||||
Deemed
dividend recorded in connection with exchange of Series A for Series C
convertible preferred stock
|
— | — | — | — | — | — | — | — | (1,178,698 | ) | — | (1,178,698 | ) | |||||||||||||||||||||||||||||||
Dividends
paid on preferred stock
|
— | — | — | — | — | — | — | — | (823,620 | ) | — | (823,620 | ) | |||||||||||||||||||||||||||||||
Dividends
accrued on preferred stock
|
— | — | — | — | — | — | — | — | (337,500 | ) | — | (337,500 | ) | |||||||||||||||||||||||||||||||
Net
loss
|
— | — | — | — | — | — | — | — | — | (19,557,135 | ) | (19,557,135 | ) | |||||||||||||||||||||||||||||||
BALANCE
AT DECEMBER 31, 2007
|
300 | 9,918,666 | 39,260,272 | 392 | — | — | 272 | — | 37,370,959 | (43,241,747 | ) | (5,870,396 | ) | |||||||||||||||||||||||||||||||
Exercise
of stock options
|
— | — | 100,000 | 1 | — | — | — | — | 999 | — | 1,000 | |||||||||||||||||||||||||||||||||
Compensation
expense associated with options issued to employees
|
— | — | — | — | — | — | — | — | 395,194 | — | 395,194 | |||||||||||||||||||||||||||||||||
Compensation
expense associated with options issued to non-employees
|
— | — | — | — | — | — | — | — | 58,133 | — | 58,133 | |||||||||||||||||||||||||||||||||
Issuance
of common stock in a private placement
|
4,615,384 | 47 | 2,986,691 | — | 2,986,738 | |||||||||||||||||||||||||||||||||||||||
Issuance
of Series D redeemable convertible preferred stock and warrants, net of
issuance costs of $205,328
|
113.5 | 4,167,080 | — | — | — | — | — | — | 1,302,592 | — | 1,302,592 | |||||||||||||||||||||||||||||||||
Adjustment
to record the carrying value of Series D redeemable convertible preferred
stock at market value on the date of sale
|
— | (181,646 | ) | — | — | — | — | — | — | 181,646 | — | 181,646 | ||||||||||||||||||||||||||||||||
Fair
value of reduction in conversion and exercise price of Series B redeemable
convertible preferred stock and warrants
|
— | 3,876,912 | — | — | — | — | — | — | 722,049 | — | 722,049 | |||||||||||||||||||||||||||||||||
Accretion
of deemed dividend associated with the reduction of conversion and
exercise prices on Series B redeemable convertible preferred stock and
warrants
|
— | (3,876,912 | ) | — | — | — | — | — | — | (722,049 | ) | — | (722,049 | ) | ||||||||||||||||||||||||||||||
Dividends
paid on preferred stock
|
— | — | — | — | — | — | — | — | (402,780 | ) | — | (402,780 | ) | |||||||||||||||||||||||||||||||
Dividends
accrued on preferred stock
|
— | — | — | — | — | — | — | — | (1,689,322 | ) | — | (1,689,322 | ) | |||||||||||||||||||||||||||||||
Net
loss
|
— | — | — | — | — | — | — | — | — | (16,451,406 | ) | (16,451,406 | ) | |||||||||||||||||||||||||||||||
BALANCE
AT DECEMBER 31, 2008
|
413.5 | $ | 13,904,100 | 43,975,656 | $ | 440 | — | $ | — | 272 | $ | — | $ | 40,204,112 | $ | (59,693,153 | ) | $ | (19,488,601 | ) |
Year
Ended December 31,
|
||||||||
2008
|
2007
|
|||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net
loss
|
$ | (16,451,406 | ) | $ | (19,557,135 | ) | ||
Adjustments
to reconcile net loss to cash used in operating
activities:
|
||||||||
Depreciation
and amortization
|
16,889 | 15,367 | ||||||
Loss
on disposal of fixed assets
|
6,472 | — | ||||||
Stock-based
compensation
|
453,327 | 503,290 | ||||||
Change
in:
|
||||||||
Prepaid
expenses and other current assets
|
3,496 | 161,714 | ||||||
Accounts
payable and accrued liabilities
|
(1,718,566 | ) | 5,284,437 | |||||
Accrued
compensation
|
(108,773 | ) | 124,028 | |||||
Deferred
revenue
|
466,666 | — | ||||||
Cash
used in operating activities
|
(17,331,895 | ) | (13,468,299 | ) | ||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Purchases
of fixed assets
|
(49,003 | ) | (24,366 | ) | ||||
Change
in restricted cash
|
1,184,702 | 470,549 | ||||||
Deposits
|
— | (4,475 | ) | |||||
Cash
provided by investing activities
|
1,135,699 | 441,708 | ||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Proceeds
from issuance of common stock, net
|
2,986,738 | — | ||||||
Proceeds
from issuance of Series B convertible preferred stock, net
|
— | 13,693,051 | ||||||
Proceeds
from issuance of Series D convertible preferred stock, net
|
5,469,672 | — | ||||||
Dividends
paid to preferred stockholders
|
(740,280 | ) | (823,620 | ) | ||||
Payment
to preferred stockholders in connection with exchange of shares
(1)
|
— | (40,000 | ) | |||||
Proceeds
from exercise of stock option
|
1,000 | 250 | ||||||
Cash
provided by financing activities
|
7,717,130 | 12,829,681 | ||||||
DECREASE
IN CASH AND EQUIVALENTS
|
(8,479,066 | ) | (196,910 | ) | ||||
CASH
AND EQUIVALENTS AT BEGINNING OF YEAR
|
9,741,518 | 9,938,428 | ||||||
CASH
AND EQUIVALENTS AT END OF YEAR
|
$ | 1,262,452 | $ | 9,741,518 | ||||
SUPPLEMENTAL
DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES
|
||||||||
Deemed
dividends on preferred stock
|
$ | 4,417,315 | $ | 8,963,083 | ||||
Dividends
accrued but not paid to preferred stockholders
|
$ | 1,689,322 | $ | 337,500 | ||||
Issuance
of warrants to preferred stockholders
|
$ | 1,302,592 | $ | 3,774,385 | ||||
Issuance
of warrants to placement agents
|
$ | — | $ | 768,621 | ||||
Exchange
of Series B for Series D preferred stock
|
$ | 9,918,666 | $ | — |
2008
|
2007
|
|||||||
Office
and computer equipment
|
$ | 73,261 | $ | 51,652 | ||||
Computer
software
|
25,896 | 7,896 | ||||||
Leasehold
improvements
|
4,095 | 4,095 | ||||||
Total
fixed assets
|
103,252 | 63,643 | ||||||
Less
accumulated depreciation and amortization
|
(44,801 | ) | (30,834 | ) | ||||
Fixed
assets, net
|
$ | 58,451 | $ | 32,809 |
Offering
|
Outstanding
(as adjusted)
|
Exercise
Price
(as adjusted)
|
Expiration Date
|
||||||
2005
Bridge Loans
|
720,000 | $ | 0.625 |
April
1, 2010
|
|||||
2005
Issuance of Common Stock - Placement agents and finders
|
1,046,143 | $ | 0.65 |
August
9, 2010
|
|||||
Series
A Preferred Stock (1):
|
|||||||||
Purchasers
– September 30, 2005 closing
|
909,090 | $ | 0.65 |
September
30, 2010
|
|||||
Purchasers
– October 3, 2005 closing
|
60,606 | $ | 0.65 |
October
3, 2010
|
|||||
2006
Issuance of Common Stock – Purchasers and placement agents
(2)
|
11,267,480 | $ | 2.00 |
March
7, 2011
|
|||||
Series
B Preferred Stock:
|
|||||||||
Purchasers
|
7,500,000 | $ | 0.65 |
April
11, 2013
|
|||||
Placement
agents
|
900,000 | $ | 1.25 |
May
2, 2012
|
|||||
Series
C Exchange
|
1,333,333 | $ | 1.25 |
May
2, 2012
|
|||||
Series
D Preferred Stock
|
4,365,381 | $ | 0.65 |
April
11, 2013
|
|||||
Total
|
28,102,033 |
December 31,
|
||||||||
2008
|
2007
|
|||||||
2000
Stock Option Plan
|
56,047 | 73,873 | ||||||
2006
Stock Incentive Plan
|
4,770,000 | 2,220,000 | ||||||
Options
issued outside of formalized plans
|
2,453,778 | 2,553,778 | ||||||
Warrants
|
28,102,033 | 28,973,047 | (1) | |||||
Preferred
stock
|
36,829,192 | 22,014,000 | (1) | |||||
Total
shares reserved for future issuance
|
72,211,050 | 55,834,698 |
Year Ended
December 31,
|
||||||||
2008
|
2007
|
|||||||
Employee
and director stock option grants:
|
||||||||
Research
and development
|
$ | 159,519 | $ | 163,558 | ||||
General
and administrative
|
235,675 | 179,675 | ||||||
395,194 | 343,233 | |||||||
Non-employee
consultants stock option grants and restricted stock
awards:
|
||||||||
Research
and development
|
24,131 | 17,233 | ||||||
General
and administrative
|
34,002 | 142,824 | ||||||
58,133 | 160,057 | |||||||
Total
stock-based compensation
|
$ | 453,327 | $ | 503,290 |
Year Ended
December 31,
|
||||||||
2008
|
2007
|
|||||||
Volatility
|
80 | % | 80 | % | ||||
Weighted-average
volatility
|
80 | % | 80 | % | ||||
Risk-free
interest rate
|
1.50%-3.28 | % | 3.57%-4.66 | % | ||||
Expected
life (years)
|
5 | 5 | ||||||
Dividend
|
0 | 0 | ||||||
Weighted-average
exercise price
|
$ | 0.46 | $ | 0.57 | ||||
Weighted-average
grant-date fair value
|
$ | 0.30 | $ | 0.38 |
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 | 8.4 | $ | 1,773,777 | ||||||||||
Options
granted
|
1,380,000 | $ | 0.57 | |||||||||||||
Options
exercised
|
(25,000 | ) | $ | 0.01 | ||||||||||||
Outstanding
at December 31, 2007
|
4,847,651 | $ | 0.67 | 8.1 | $ | 1,308,961 | ||||||||||
Options
granted
|
2,560,000 | $ | 0.46 | |||||||||||||
Options
exercised
|
(100,000 | ) | $ | 0.01 | ||||||||||||
Options
canceled
|
(27,826 | ) | $ | 2.23 | ||||||||||||
Outstanding
at December 31, 2008
|
7,279,825 | $ | 0.60 | 7.9 | $ | 989,718 | ||||||||||
Exercisable
at December 31, 2008
|
4,193,147 | $ | 0.68 | 6.6 | $ | 894,331 |
2008
|
2007
|
|||||||
Net
operating loss carryforwards
|
$ | 7,128,000 | $ | 4,547,000 | ||||
Research
and development expenses
|
13,681,000 | 9,718,000 | ||||||
Tax
credits
|
1,311,000 | 941,000 | ||||||
Capital
loss carryforward
|
340,000 | 403,000 | ||||||
Stock-based
compensation
|
449,000 | 375,000 | ||||||
Gross
deferred tax asset
|
22,909,000 | 15,984,000 | ||||||
Valuation
allowance
|
(22,909,000 | ) | (15,984,000 | ) | ||||
Net
deferred tax asset
|
$ | — | $ | — |
Year Ended
December 31,
|
||||||||
2008
|
2007
|
|||||||
Stock
options
|
7,279,825 | 4,847,651 | ||||||
Warrants
|
28,102,033 | 26,873,047 | ||||||
Conversion
of preferred stock
|
36,829,192 | 18,264,000 |
ITEM 9.
|
CHANGES
AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
|
ITEM
10.
|
DIRECTORS,
EXECUTIVE OFFICERS AND CORPORATE
GOVERNANCE.
|
Name
|
Age
|
Position
|
||
Stephen
A. Hill, B.M. B.Ch., M.A., F.R.C.S.
|
50
|
Chairman
of the Board
|
||
Harry
S. Palmin
|
39
|
President,
Chief Executive Officer, Director
|
||
Elias
B. Nyberg, DVM, BVSc, MACVS, MRCVS, MBA
|
55
|
Vice
President of Regulatory, Quality and Compliance
|
||
Christopher
J. Pazoles, Ph.D.
|
58
|
Vice
President of Research and Development
|
||
Joanne
M. Protano
|
40
|
Vice
President, Chief Financial Officer and Treasurer
|
||
Kristin
C. Schuhwerk
|
38
|
Vice
President of Clinical Development and Operations
|
||
Michael
J. Doyle (1) (2) (3)
|
50
|
Director
|
||
Sim
Fass, Ph.D. (1) (2) (3)
|
67
|
Director
|
||
James
S. Manuso, Ph.D.
|
60
|
Director
|
||
David
B. McWilliams (2) (3)
|
65
|
Director
|
||
Howard
M. Schneider (1) (3)
|
65
|
Director
|
Name and Principal Position
|
Year
|
Salary
($)
|
Bonus
($) (3)
|
Option
Awards ($) (4)
|
All other
compensation
($)
|
Total ($)
|
||||||||||||||||
Harry
S. Palmin (1)
|
2008
|
$ | 270,000 | $ | 40,500 | $ | 110,560 | $ | 0 | $ | 421,060 | |||||||||||
President,
Chief Executive
|
2007
|
245,000 | 75,000 | 59,660 | 0 | 379,660 | ||||||||||||||||
Officer
|
||||||||||||||||||||||
Christopher
J. Pazoles (1)
|
2008
|
$ | 235,000 | $ | 35,250 | $ | 55,280 | $ | 0 | $ | 325,530 | |||||||||||
Vice
President of Research
|
2007
|
216,720 | 60,000 | 37,288 | 0 | 314,008 | ||||||||||||||||
and
Development
|
||||||||||||||||||||||
Kristin
C. Schuhwerk (1) (2)
|
2008
|
$ | 200,000 | $ | 30,000 | $ | 55,280 | $ | 0 | $ | 285,280 | |||||||||||
Vice
President of Clinical
|
2007
|
169,904 | 50,000 | 37,288 | 0 | 257,192 | ||||||||||||||||
Development
and Operations
|
Individual Grants
|
|||||||||||||||
Name
|
Year
of Grant
|
Number of
securities
underlying
unexercised
options
(#)
exercisable
|
Number of
securities
underlying
unexercised
options
(#)
unexercisable
|
Exercise or
base price
($/share)
|
Expiration
date
|
||||||||||
Harry
S. Palmin
|
2008(1)
|
— | 400,000 | $ | 0.43 |
12/15/2018
|
|||||||||
2007(1)
|
66,666 | 133,334 | 0.45 |
12/17/2017
|
|||||||||||
2006(1)
|
100,000 | 50,000 | 0.91 |
12/11/2016
|
|||||||||||
2005(2)
|
250,000 | — | 0.01 |
1/31/2015
|
|||||||||||
2005(2)
|
150,000 | — | 0.01 |
3/31/2015
|
|||||||||||
2004(3)
|
330,000 | — | 0.01 |
4/1/2014
|
|||||||||||
2003(4)
|
7,130 | — | 0.70 |
8/1/2013
|
|||||||||||
Christopher
J. Pazoles
|
2008(1)
|
— | 200,000 | $ | 0.43 |
12/15/2018
|
|||||||||
2007(1)
|
41,666 | 83,334 | 0.45 |
12/17/2017
|
|||||||||||
2006(1)
|
66,666 | 33,334 | 0.91 |
12/11/2016
|
|||||||||||
2005(5)
|
200,000 | — | 0.01 |
4/8/2015
|
|||||||||||
2004(6)
|
16,667 | — | 0.01 |
4/1/2014
|
|||||||||||
Kristin
C. Schuhwerk
|
2008(1)
|
— | 200,000 | $ | 0.43 |
12/15/2018
|
|||||||||
2007(1)
|
41,666 | 83,334 | 0.45 |
12/17/2017
|
|||||||||||
2006(1)
|
50,000 | 25,000 | 0.91 |
12/11/2016
|
|||||||||||
2005(7)
|
100,000 | — | 2.20 |
7/1/2015
|
(1)
|
These
shares vest annually in increments of one-third over three years from the
date of grant. The exercise price equals the closing price on
the date of grant.
|
(2)
|
These
shares initially vested over a two-year period. Pursuant to
their terms, the shares fully vested upon the completion of a non-bridge
loan financing, which occurred in the second quarter of
2005. The exercise price equals the fair market value of our
common stock on the date of grant as determined by our board of
directors.
|
(3)
|
These
shares initially vested one-third upon grant and one third annually over
the following two years. Pursuant to their terms, one additional year of
vesting occurred upon the completion of a non-bridge loan financing, which
occurred in the second quarter of 2005. The exercise price
equals the fair market value of our common stock on the date of grant as
determined by our board of
directors.
|
(4)
|
These
shares vest annually in increments of one-third over three years from the
date of grant. The exercise price equals the fair market value of our
common stock on the date of grant as determined by our board of
directors.
|
(5)
|
These
shares vested in increments of one-fourth every six months over two years
from the date of grant. The exercise price equals the fair market value of
our common stock on the date of grant as determined by our board of
directors.
|
(6)
|
These
shares represent the fully vested portion of an option grant made to Mr.
Pazoles in consideration of consulting services delivered during
2004. Pursuant to their terms, the shares vested at the
completion of the consulting engagement and expire ten years from the date
of grant.
|
(7)
|
These
shares vest in increments of one-fourth every six months over two years
from the date of grant. The exercise price equals the closing price on the
date of grant.
|
Name and Principal Position
|
Year
|
Director
Fees
($) (3)
|
Option
Awards
($) (4)
|
All other
compensation
($)
|
Total ($)
|
|||||||||||||
Stephen
A. Hill, Chairman (1)
|
2008
|
$ | 38,000 | $ | 37,924 | $ | — | $ | 75,924 | |||||||||
Michael
J. Doyle, Director (1)
|
2008
|
30,250 | 37,924 | — | 68,174 | |||||||||||||
Sim
Fass, Director (1)
|
2008
|
30,250 | 37,924 | — | 68,174 | |||||||||||||
James
S. Manuso, Director (1)
|
2008
|
23,000 | 37,924 | 60,924 | ||||||||||||||
David
B. McWilliams, Director (1)
|
2008
|
26,750 | 37,924 | — | 64,674 | |||||||||||||
Simyon
Palmin, Director and director of
Russian relations (2)
|
2008
|
— | — | 88,133 | 88,133 | |||||||||||||
Howard
M. Schneider, Director (1)
|
2008
|
36,750 | 37,924 | — | 74,674 |
(1) |
As
of December 31, 2008, outstanding options to purchase common stock held by
directors were as follows: Dr. Hill 270,000; Mr. Doyle 270,000; Dr. Fass
270,000; Dr. Manuso 220,000; Mr. McWilliams 322,778; Mr. Schneider
170,000.
|
|
(2) |
As
of December 31, 2008, Mr. Palmin held 300,000 options to purchase common
stock. In addition, The Liberty Irrevocable Trust 2008, a trust for which
his wife Alla is sole trustee, held 170,000 options to purchase common
stock. The total of 470,000 options had been granted to Mr. Palmin during
2004 and 2005 in his capacity as chairman and chief executive
officer.
|
|
(3)
|
Director
fees include all fees earned for director services including quarterly
fees, meeting fees and committee chairman
fees.
|
(4)
|
The
fair value of each stock award was estimated on the grant date using the
Black-Scholes option-pricing model. See Note 6 to the financial
statements for a description of the assumptions used in estimating the
fair value of stock options.
|
Equity compensation plan information | ||||||||||||
Plan category
|
Number of shares to
be issued upon
exercise of
outstanding options,
warrants and rights
(#)
|
Weighted-average
exercise price of
outstanding options,
warrants and rights
($)
|
Number of shares
remaining available for
future issuance under
equity compensation plans
(excluding shares reflected
in column (a)) (#)
|
|||||||||
(a)
|
(b)
|
(c)
|
||||||||||
Equity
compensation plans approved by stockholders
|
4,826,047 | $ | 0.61 | 230,000 | ||||||||
Equity
compensation plans not approved by stockholders
|
2,453,778 | $ | 0.57 | 0 | ||||||||
Total
|
7,279,825 | $ | 0.60 | 230,000 |
ITEM
12.
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
STOCKHOLDER MATTERS
|
|
·
|
Each
person known by us to be the beneficial owner of more than five percent of
our common stock;
|
|
·
|
Each
of our directors;
|
|
·
|
Each
executive officer named in the summary compensation table;
and
|
|
·
|
All
of our current directors and executive officers as a
group.
|
Shares Beneficially Owned (3)
|
||||||||||||||||
Name and Address of Beneficial Owner
|
Outstanding
|
Right to Acquire
|
Total
|
Percentage
|
||||||||||||
Liberty
Irrevocable Trust 2008 (1)
99-60
Florence Street, Apt. 4A
Chestnut
Hill, MA 02467
|
1,975,481 | 470,000 | 2,445,481 | 5.5 | % | |||||||||||
Harry
S. Palmin (2)
|
641,118 | 903,796 | 1,544,914 | 3.4 | % | |||||||||||
Christopher
J. Pazoles
|
0 | 324,999 | 324,999 | * | ||||||||||||
Kristin
C. Schuhwerk
|
0 | 191,666 | 191,666 | * | ||||||||||||
Stephen
A. Hill
|
0 | 166,250 | 166,250 | * | ||||||||||||
Michael
J. Doyle
|
0 | 185,000 | 185,000 | * | ||||||||||||
Sim
Fass
|
0 | 185,000 | 185,000 | * | ||||||||||||
James
S. Manuso
|
0 | 122,500 | 122,500 | * | ||||||||||||
David
B. McWilliams
|
0 | 237,778 | 237,778 | * | ||||||||||||
Howard
M. Schneider
|
100,000 | 85,000 | 85,000 | * | ||||||||||||
All
directors and officers as a group (11 persons)
|
741,118 | 2,601,988 | 3,343,106 | 7.2 | % |
*
|
Less
than one percent.
|
(1)
|
Shares
outstanding include 236,542 shares owned by Alla Palmin, trustee of the
Liberty Irrevocable Trust 2008. Shares in the “Right to Acquire” column
include 300,000 options to purchase common stock held by Simyon Palmin, a
founder of Novelos, a director until August 15, 2008, the father of Harry
Palmin and husband of Alla Palmin.
|
(2)
|
Shares
owned by H. Palmin include 94,000 shares owned by his wife, Deanna
Palmin.
|
(3)
|
The
terms of our Series E preferred stock and common stock purchase warrants
issued to the holders of Series E preferred stock provide that the number
of shares of common stock to be obtained by each of the holders of Series
E preferred stock and common stock purchase warrants, upon conversion of
the Series E preferred stock or exercise of the common stock purchase
warrants, cannot exceed the number of shares that, when combined with all
other shares of our common stock and securities owned by each of them,
would result in any one of them owning more than 4.99% or 9.99%, as
applicable in the certificate of designations and warrant agreement, of
our outstanding common stock, provided, however that this limitation may
be revoked by the stockholder upon 61 days prior notice to us. For this
reason, holders of our Series E preferred stock who might otherwise have
the right to acquire 5% or more of our common stock have been omitted from
this table. Such limitations do not apply in the event of automatic
conversion of Series E preferred stock. Similar blocking
provisions apply to outstanding shares of our Series C preferred stock and
common stock purchase warrants issued to the holders of Series C preferred
stock and therefore holders of our Series C preferred stock who might
otherwise have the right to acquire 5% or more of our common stock have
also been omitted from this table.
|
Name and Address of Beneficial Owner
|
Outstanding
|
Issuable upon
automatic
conversion of Series
E preferred stock
|
Total pro
forma
ownership
(1)
|
Pro forma
ownership
percentage
(2)
|
||||||||||||
Xmark
affiliated funds (3)
90
Grove Street
Ridgefield,
CT 06877
|
0 | 9,082,045 | 9,082,845 | 9.7 | % | |||||||||||
Orbimed
affiliated funds (4)
767
Third Avenue, 30th
Floor
New
York, NY 10017
|
0 | 10,878,150 | 10,878,150 | 11.6 | % | |||||||||||
Knoll
affiliated funds (5)
666
Fifth Avenue, Suite 3702
New
York, NY 10103
|
1,677,785 | 9,247,776 | 10,925,561 | 11.7 | % | |||||||||||
Hunt
Bioventures
1900
N. Akard Street
Dallas,
TX 75201
|
0 | 5,056,860 | 5.056,860 | 5.4 | % | |||||||||||
Purdue
Pharma, L.P. (6)
One
Stamford Forum
201
Tresser Blvd.
Stamford,
CT 06901-3431
|
0 | 15,384,614 | 15,384,614 | 16.4 | % |
(1)
|
Pro
forma ownership does not include 21,096,150 shares of common stock
issuable upon exercise of outstanding warrants, due to the effect of the
blocker provisions described in Note 3 of the preceding
table.
|
(2)
|
Based
on 93,625,101 shares of common stock outstanding, which reflects the
number of shares of common stock outstanding as of March 20, 2009, plus
the total number of shares issuable upon conversion of all of the
outstanding shares of Series E preferred
stock.
|
(3)
|
Includes
Xmark Opportunity Partners LLC, Xmark Opportunity Fund, Ltd., Xmark
Opportunity Fund, L.P., Xmark JV Investment Partners,
LLC.
|
(4)
|
Includes
Orbimed Advisors LLC, Caduceus Capital Master Fund Limited, Caduceus
Capital II, LP, UBS Eucalyptus Fund, L.L.C., PW Eucalyptus Fund, Ltd., and
Summer Street Life Sciences Investors
LLC.
|
(5)
|
Includes
Knoll Capital, Knoll Special Opportunities Fund II Master Fund, Ltd.,
Europa International, Inc.
|
(6)
|
On
February 12, 2009, Purdue Pharma L.P. transferred its shares of Series E
Preferred Stock and warrants to purchase common stock of Novelos to Beacon
Company and Rosebay Medical Company L.P., which are independent associated
companies of Purdue Pharma L.P.
|
2008
|
2007
|
|||||||
Audit
|
$ | 81,500 | $ | 81,500 | ||||
Audit
Related
|
— | 14,125 | ||||||
Tax
|
— | — | ||||||
All
Other
|
— | — | ||||||
Total
|
$ | 81,500 | $ | 95,625 |
Exhibit
No.
|
Description
|
Filed
with this
Form
10-K
|
Incorporated by Reference
|
|||||||
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 E convertible preferred
stock
|
8-K
|
February
18, 2009
|
4.1
|
||||||
3.3
|
Certificate
of Designations of Series C cumulative convertible preferred
stock
|
10-QSB
|
May
8, 2007
|
3.2
|
||||||
3.4
|
By-laws
|
8-K
|
June
17, 2005
|
2
|
||||||
10.1
**
|
Employment
agreement with Christopher J. Pazoles dated July 15, 2005
|
10-QSB
|
August
15, 2005
|
10.4
|
||||||
10.2
**
|
Employment
Agreement with Harry S. Palmin dated January 31, 2006
|
8-K
|
February
6, 2006
|
99.1
|
||||||
10.3**
|
2000
Stock Option and Incentive Plan
|
SB-2
|
November
16, 2005
|
10.2
|
||||||
10.4
**
|
Form
of 2004 non-plan non-qualified stock option
|
SB-2
|
November
16, 2005
|
10.3
|
||||||
10.5
**
|
Form
of non-plan non-qualified stock option used from February to May
2005
|
SB-2
|
November
16, 2005
|
10.4
|
||||||
10.6
**
|
Form
of non-plan non-qualified stock option used after May 2005
|
SB-2
|
November
16, 2005
|
10.5
|
||||||
10.7
|
Form
of common stock purchase warrant issued in March 2005
|
SB-2
|
November
16, 2005
|
10.6
|
||||||
10.8
|
Form
of securities purchase agreement dated May 2005
|
8-K
|
June
2, 2005
|
99.1
|
||||||
10.9
|
Form
of subscription agreement dated September 30, 2005
|
8-K
|
October
3, 2005
|
99.1
|
||||||
10.10
|
Form
of Class A common stock purchase warrant dated September 30,
2005
|
8-K
|
October
3, 2005
|
99.3
|
||||||
10.12
|
Consideration
and new technology agreement dated April 1, 2005 with ZAO
BAM
|
10-QSB
|
August
15, 2005
|
10.2
|
||||||
10.13
|
Letter
agreement dated March 31, 2005 with The Oxford Group, Ltd.
|
10-QSB
|
August
15, 2005
|
10.3
|
||||||
10.14
|
Form
of securities purchase agreement dated March 2, 2006
|
8-K
|
March
3, 2006
|
99.2
|
Exhibit
No.
|
Description
|
Filed
with this
Form
10-K
|
Incorporated by Reference
|
|||||||
Form
|
Filing Date
|
Exhibit
No.
|
||||||||
10.15
|
Form
of common stock purchase warrant dated March 2006
|
8-K
|
March
3, 2006
|
99.3
|
||||||
10.16**
|
2006
Stock Incentive Plan
|
10-QSB
|
November
6, 2006
|
10.1
|
||||||
10.17
|
Form
of Incentive Stock Option under Novelos Therapeutics, Inc.’s 2006 Stock
Incentive Plan
|
8-K
|
December
15, 2006
|
10.1
|
||||||
10.18
|
Form
of Non-Statutory Stock Option under Novelos Therapeutics, Inc.’s 2006
Stock Incentive Plan
|
8-K
|
December
15, 2006
|
10.2
|
||||||
10.19
|
Form
of Non-Statutory Director Stock Option under Novelos Therapeutics, Inc.’s
2006 Stock Incentive Plan
|
8-K
|
December
15, 2006
|
10.3
|
||||||
10.20
|
Securities
Purchase Agreement dated April 12, 2007
|
10-QSB
|
May
8, 2007
|
10.1
|
||||||
10.21
|
Letter
Amendment dated May 2, 2007 to the Securities Purchase
Agreement
|
10-QSB
|
May
8, 2007
|
10.2
|
||||||
10.22
|
Registration
Rights Agreement dated May 2, 2007
|
10-QSB
|
May
8, 2007
|
10.3
|
||||||
10.23
|
Agreement
to Exchange and Consent dated May 1, 2007
|
10-QSB
|
May
8, 2007
|
10.5
|
||||||
10.25
|
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
|
||||||
10.26
|
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
|
||||||
10.27
|
Securities
Purchase Agreement dated March 26, 2008
|
8-K
|
April
14, 2008
|
10.1
|
||||||
10.28
|
Amendment
to Securities Purchase Agreement dated April 9, 2008
|
8-K
|
April
14, 2008
|
10.2
|
||||||
10.29
|
Registration
Rights Agreement dated April 11, 2008
|
8-K
|
April
14, 2008
|
10.3
|
||||||
10.30
|
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
|
||||||
10.31
|
Warrant
Amendment Agreement dated April 11, 2008
|
8-K
|
April
14, 2008
|
10.5
|
Exhibit
No.
|
Description
|
Filed
with this
Form
10-K
|
|
Incorporated by Reference
|
||||||
Form
|
Filing Date
|
Exhibit
No.
|
||||||||
10.32
|
Amendment
to Registration Rights Agreement dated April 11, 2008
|
8-K
|
April
14, 2008
|
10.4
|
||||||
10.33
|
Securities
Purchase Agreement dated August 14, 2008
|
8-K
|
August
18, 2008
|
10.1
|
||||||
10.34
|
Securities
Purchase Agreement dated February 11, 2009
|
8-K
|
February
18, 2009
|
10.1
|
||||||
10.35
|
Registration
Rights Agreement dated February 11, 2009
|
8-K
|
February
18, 2009
|
10.2
|
||||||
10.36
|
Series
D Preferred Stock Consent and Agreement to Exchange dated February 10,
2009
|
8-K
|
February
18, 2009
|
10.3
|
||||||
10.37
|
Warrant
Amendment Agreements dated February 11, 2009
|
8-K
|
February
18, 2009
|
10.4
|
||||||
10.38
|
Amendment
No. 2 to Registration Rights Agreement dated February 11,
2009
|
8-K
|
February
18, 2009
|
10.5
|
||||||
10.39
|
Collaboration
Agreement dated February 11, 2009(*)
|
X
|
||||||||
31.1
|
Certification
of chief executive officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
X
|
||||||||
31.2
|
Certification
of chief financial officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
X
|
||||||||
32.1
|
Certification
of chief executive officer and chief financial officer pursuant to Section
906 of the Sarbanes-Oxley Act of 2002
|
X
|
*
|
Portions
of the exhibit have been omitted pursuant to a request for confidential
treatment.
|
**
|
Management
contract or compensatory
plan.
|
NOVELOS
THERAPEUTICS, INC.
|
|
By:
|
/s/ Harry S. Palmin
|
Harry
S. Palmin
|
|
Title: President,
Chief Executive Officer
|
|
Date:
|
March 30,
2009
|
By:
|
/s/ Harry S. Palmin
|
Harry
S. Palmin
|
|
Title: Chief
Executive Officer and Director (Principal Executive
Officer)
|
|
Date:
|
March 30, 2009
|
By:
|
/s/ Joanne M. Protano
|
Joanne
M. Protano
|
|
Title: Chief
Financial Officer (Principal Accounting Officer)
|
|
Date:
|
March 30, 2009
|
By:
|
/s/ Stephen A. Hill
|
Stephen
A. Hill
|
|
Title: Chairman
of the Board of Directors
|
|
Date:
|
March 30, 2009
|
By:
|
/s/ Michael J. Doyle
|
Michael
J. Doyle
|
|
Title: Director
|
|
Date:
|
March 30, 2009
|
By:
|
/s/ Sim Fass
|
Sim
Fass
|
|
Title: Director
|
|
Date:
|
March 30,
2009
|
By:
|
/s/ James S. Manuso
|
James
S. Manuso
|
|
Title: Director
|
|
Date:
|
March 30, 2009
|
By:
|
/s/ David B. McWilliams
|
David
B. McWilliams
|
|
Title: Director
|
|
Date:
|
March 30, 2009
|
By:
|
/s/ Howard M. Schneider
|
Howard
M. Schneider
|
|
Title: Director
|
|
Date:
|
March 30,
2009
|