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x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
For the quarterly period ended: June 30, 2011
|
|
¨
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
|
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For the transition period from ______________ to ______________
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|
DELAWARE
|
04-3321804
|
|
|
(
State or other jurisdiction of
incorporation or organization
)
|
(
IRS Employer
Identification No.
)
|
|
Large accelerated filer
|
¨
|
Accelerated filer
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¨
|
|
|
Non-accelerated filer
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¨
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(Do not check if a smaller reporting company)
|
Smaller reporting company
|
x
|
| PART I. | FINANCIAL INFORMATION | |
|
Item 1.
|
Financial Statements
|
3 |
|
Item 2.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
18 |
|
Item 4.
|
Controls and Procedures
|
23 |
|
PART II. OTHER INFORMATION
|
||
|
Item 1.
|
Legal Proceedings
|
24 |
|
Item 1A.
|
Risk Factors
|
25 |
|
Item 2.
|
Unregistered Sales of Equity Securities and Use of Proceeds
|
39 |
|
Item 3.
|
Defaults Upon Senior Securities
|
39 |
|
Item 4.
|
Reserved
|
39 |
|
Item 5.
|
Other Information
|
39 |
|
Item 6.
|
Exhibits
|
39 |
|
Item 1.
|
Financial Statements
|
|
June 30,
2011
|
December 31,
2010
|
|||||||
|
(unaudited)
|
||||||||
|
ASSETS
|
||||||||
|
CURRENT ASSETS:
|
||||||||
|
Cash and cash equivalents
|
$
|
3,313,398
|
$
|
673,739
|
||||
|
Restricted cash
|
55,000
|
555,000
|
||||||
|
Prepaid expenses and other current assets
|
53,115
|
51,042
|
||||||
|
Deferred issuance costs
|
57,700
|
—
|
||||||
|
Total current assets
|
3,479,213
|
1,279,781
|
||||||
|
FIXED ASSETS, NET
|
3,249,334
|
3,510,489
|
||||||
|
EXCESS PURCHASE PRICE OVER NET ASSETS ACQUIRED
|
1,675,462
|
—
|
||||||
|
OTHER ASSETS
|
27,222
|
11,872
|
||||||
|
TOTAL ASSETS
|
$
|
8,431,231
|
$
|
4,802,142
|
||||
|
CURRENT LIABILITIES:
|
||||||||
|
Accounts payable and accrued liabilities
|
$
|
365,793
|
$
|
392,881
|
||||
|
Accrued interest
|
—
|
305,049
|
||||||
|
Derivative liability
|
81,540
|
—
|
||||||
|
Notes payable, current portion
|
—
|
204,802
|
||||||
|
Capital lease obligations, current portion
|
2,159
|
2,085
|
||||||
|
Total current liabilities
|
449,492
|
904,817
|
||||||
|
LONG-TERM LIABILITIES:
|
||||||||
|
Convertible debt
|
—
|
2,720,985
|
||||||
|
Notes payable, net of current portion
|
450,000
|
920,941
|
||||||
|
Deferred rent
|
118,443
|
115,311
|
||||||
|
Capital lease obligations, net of current portion
|
5,228
|
6,326
|
||||||
|
Total long-term liabilities
|
573,671
|
3,763,563
|
||||||
|
COMMITMENTS AND CONTINGENCIES
|
||||||||
|
STOCKHOLDERS’ EQUITY:
|
||||||||
|
Common stock, $0.00001 par value; 150,000,000 shares authorized; 26,826,157 and 12,820,102 shares issued and outstanding at June 30, 2011 and December 31, 2010, respectively
|
268
|
128
|
||||||
|
Additional paid-in capital
|
35,013,267
|
24,178,638
|
||||||
|
Deficit accumulated during the development stage
|
(27,605,467
|
)
|
(24,045,004
|
)
|
||||
|
Total stockholders’ equity
|
7,408,068
|
133,762
|
||||||
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
8,431,231
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$
|
4,802,142
|
||||
|
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
Cumulative
Development-
Stage Period
from November
7, 2002 (date of
inception)
through June 30,
2011
|
||||||||||||||||||
|
2011
|
2010
|
2011
|
2010
|
|||||||||||||||||
|
COSTS AND EXPENSES:
|
||||||||||||||||||||
|
Research and development
|
$ | 961,953 | $ | 963,144 | $ | 1,433,356 | $ | 2,100,116 | $ | 18,639,315 | ||||||||||
|
General and administrative
|
796,714 | 567,226 | 928,440 | 923,666 | 7,898,618 | |||||||||||||||
|
Merger costs
|
495,773 | — | 746,207 | — | 799,133 | |||||||||||||||
|
Total costs and expenses
|
2,254,440 | 1,530,370 | 3,108,003 | 3,023,782 | 27,337,066 | |||||||||||||||
|
LOSS FROM OPERATIONS
|
(2,254,440 | ) | (1,530,370 | ) | (3,108,003 | ) | (3,023,782 | ) | (27,337,066 | ) | ||||||||||
|
OTHER INCOME (EXPENSE):
|
||||||||||||||||||||
|
Grant income
|
— | — | 44,479 | — | 244,479 | |||||||||||||||
|
Loss on derivative warrants
|
(70,393 | ) | — | (70,393 | ) | — | (70,393 | ) | ||||||||||||
|
Interest expense, net
|
(270,378 | ) | (91,438 | ) | (426,546 | ) | (373,852 | ) | (443,648 | ) | ||||||||||
|
Other income (expense)
|
— | — | — | (573 | ) | 1,161 | ||||||||||||||
|
Total other expense, net
|
(340,771 | ) | (91,438 | ) | (452,460 | ) | (374,425 | ) | (268,401 | ) | ||||||||||
|
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
|
$ | (2,595,211 | ) | $ | (1,621,808 | ) | $ | (3,560,463 | ) | $ | (3,398,207 | ) | $ | (27,605,467 | ) | |||||
|
BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE
|
$ | (0.10 | ) | $ | (0.13 | ) | $ | (0.18 | ) | $ | (0.27 | ) | $ | (2.74 | ) | |||||
|
SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE
|
25,743,781 | 12,820,102 | 19,317,642 | 12,820,102 | 10,075,059 | |||||||||||||||
|
Six Months Ended
June 30,
|
Cumulative
Development-Stage Period
from
November
7, 2002
through
June 30,
2011
|
|||||||||||
|
2011
|
2010
|
|||||||||||
|
Net loss
|
$ | (3,560,463 | ) | $ | (3,398,207 | ) | $ | (27,605,467 | ) | |||
|
Adjustments to reconcile net loss to cash used in operating activities:
|
||||||||||||
|
Depreciation and amortization
|
290,739 | 291,677 | 2,121,936 | |||||||||
|
Stock-based compensation
|
257,586 | 241,353 | 2,204,999 | |||||||||
|
Intrinsic value of beneficial conversion feature associated with convertible debt
|
257,973 | 213,792 | 471,765 | |||||||||
|
Issuance of stock for technology and services
|
— | — | 89,520 | |||||||||
|
Impairment of intangible assets
|
— | — | 19,671 | |||||||||
|
Loss on disposal of fixed assets
|
— | — | 30,468 | |||||||||
|
Loss on derivative warrants
|
70,393 | — | 70,393 | |||||||||
|
Changes in:
|
||||||||||||
|
Prepaid expenses and other current assets
|
25,969 | (19,189 | ) | (36,945 | ) | |||||||
|
Accounts payable and accrued liabilities
|
(407,216 | ) | (115,989 | ) | (14,335 | ) | ||||||
|
Accrued interest
|
158,672 | 140,448 | 463,721 | |||||||||
|
Deferred rent
|
3,132 | 289 | 118,443 | |||||||||
|
Cash used in operating activities
|
(2,903,215 | ) | (2,645,826 | ) | (22,065,831 | ) | ||||||
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
|
Cash acquired in a business combination
|
905,649 | — | 905,649 | |||||||||
|
Purchases of fixed assets
|
(23,069 | ) | — | (5,391,250 | ) | |||||||
|
Proceeds from sale of fixed assets
|
— | — | 7,000 | |||||||||
|
Purchases of short-term certificates of deposit
|
— | — | (5,500,730 | ) | ||||||||
|
Proceeds from short-term certificates of deposit
|
— | — | 5,500,730 | |||||||||
|
Change in restricted cash
|
500,000 | — | (55,000 | ) | ||||||||
|
Payment for intangible assets
|
— | — | (19,671 | ) | ||||||||
|
Cash provided by (used) in investing activities
|
1,382,580 | — | (4,553,272 | ) | ||||||||
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
|
Proceeds from issuance of convertible notes
|
— | 2,720,985 | 2,720,985 | |||||||||
|
Proceeds from long-term obligations
|
— | — | 1,677,945 | |||||||||
|
Payments on long-term obligations
|
(675,743 | ) | (93,818 | ) | (1,227,944 | ) | ||||||
|
Payments on capital lease obligations
|
(1,024 | ) | (956 | ) | (3,587 | ) | ||||||
|
Proceeds from issuance of common stock, net of issuance costs
|
4,866,406 | — | 26,576,114 | |||||||||
|
Proceeds from exercise of warrant
|
— | — | 250,000 | |||||||||
|
Repurchase of common stock
|
— | — | (31,667 | ) | ||||||||
|
Cash in lieu of fractional shares in a business combination
|
(145 | ) | — | (145 | ) | |||||||
|
Change in deferred issuance costs
|
(29,200 | ) | 89,098 | (29,200 | ) | |||||||
|
Cash provided by financing activities
|
4,160,294 | 2,715,309 | 29,932,501 | |||||||||
|
INCREASE IN CASH AND EQUIVALENTS
|
2,639,659 | 69,483 | 3,313,398 | |||||||||
|
CASH AND EQUIVALENTS AT BEGINNING OF PERIOD
|
673,739 | 980,125 | — | |||||||||
|
CASH AND EQUIVALENTS AT END OF PERIOD
|
$ | 3,313,398 | $ | 1,049,608 | $ | 3,313,398 | ||||||
|
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
|
||||||||||||
|
Interest paid
|
$ | 13,700 | $ | 29,300 | $ | 208,689 | ||||||
|
Fair value of derivative warrants reclassified to additional paid-in capital upon cashless exercise
|
$ | 48,339 | $ | — | $ | 48,339 | ||||||
|
Issuance of common stock in connection with the conversion of notes payable and associated accrued interest
|
$ | 3,184,706 | $ | — | $ | 3,184,706 | ||||||
|
Fair value of assets acquired in exchange for securities in a business combination
|
$ | 984,057 | $ | — | $ | 984,057 | ||||||
|
Fair value of liabilities assumed in exchange for securities in a business combination
|
$ | (439,616 | ) | $ | — | $ | (439,616 | ) | ||||
|
Excess of purchase price over net assets acquired in a business combination
|
$ | 1,675,462 | $ | — | $ | 1,675,462 | ||||||
|
1.
|
NATURE OF BUSINESS, BASIS OF PRESENTATION
|
|
2.
|
FAIR VALUES OF ASSETS AND LIABILITIES
|
|
|
·
|
Level 1: Input prices quoted in an active market for identical financial assets or liabilities.
|
|
|
·
|
Level 2: Inputs other than prices quoted in Level 1, such as prices quoted for similar financial assets and liabilities in active markets, prices for identical assets and liabilities in markets that are not active or other inputs that are observable or can be corroborated by observable market data.
|
|
|
·
|
Level 3: Input prices quoted that are significant to the fair value of the financial assets or liabilities which are not observable or supported by an active market.
|
|
June 30, 2011
|
||||||||||||||||
|
Level 1
|
Level 2
|
Level 3
|
Fair Value
|
|||||||||||||
|
Liabilities:
|
||||||||||||||||
|
Warrants
|
$ | - | $ | 81,540 | $ | - | $ | 81,540 | ||||||||
|
December 31, 2010
|
||||||||||||||||
|
Level 1
|
Level 2
|
Level 3
|
Fair Value
|
|||||||||||||
|
Liabilities:
|
||||||||||||||||
|
Warrants
|
$ | - | $ | - | $ | - | $ | - | ||||||||
|
3.
|
ACQUISITION
|
|
Consideration - issuance of securities
|
$ | 2,219,903 | ||
|
Prepaid expenses and other assets
|
$ | 71,892 | ||
|
Fixed assets
|
6,515 | |||
|
Accrued liabilities
|
(380,130 | ) | ||
|
Derivative liability
|
(59,485 | ) | ||
|
Excess of purchase price over net assets acquired
|
1,675,462 | |||
|
Total purchase price – net of cash acquired of $905,649
|
$ | 1,314,254 |
|
4.
|
|
|
5.
|
LONG-TERM NOTES PAYABLE
|
|
6.
|
STOCKHOLDERS’ EQUITY
|
|
Offering
|
Number of Shares
Issuable Upon
Exercise of
Outstanding
Warrants
|
Exercise
Price
|
Expiration Date
|
|||||||
|
April 8, 2011 Private Placement
|
7,039,468
|
$
|
0.75
|
March 31, 2016
|
||||||
|
Series B Preferred Stock – placement agents
|
5,392
|
$
|
191.25
|
May 2, 2012
|
||||||
|
Series C Exchange
|
8,169
|
$
|
191.25
|
May 2, 2012
|
||||||
|
Series E Preferred Stock
|
60,330
|
$
|
99.45
|
December 31, 2015
|
||||||
|
August 2009 Private Placement
|
31,194
|
$
|
100.98
|
December 31, 2015
|
||||||
|
July 2010 Direct Offering (1)
|
77,729
|
$
|
0.75
|
July 27, 2015
|
||||||
|
Preferred Incentive Warrants
|
105,040
|
$
|
16.07
|
July 27, 2015
|
||||||
|
|
||||||||||
|
Total
|
7,327,322
|
|||||||||
|
7.
|
STOCK-BASED COMPENSATION
|
|
Six Months Ended
June 30,
|
Cumulative
Development
Stage from
November 7,
2002 (date of
inception) to
June 30, 2011
|
|||||||||||
|
2011
|
2010
|
|||||||||||
|
Employee and director stock option grants:
|
||||||||||||
|
Research and development
|
$ | 54,991 | $ | 42,048 | $ | 353,376 | ||||||
|
General and administrative
|
136,455 | 199,305 | 1,713,758 | |||||||||
| 191,446 | 241,353 | 2,067,134 | ||||||||||
|
Non-employee consultant stock option grants:
|
||||||||||||
|
Research and development
|
17,287 | — | 17,287 | |||||||||
|
General and administrative
|
48,853 | — | 120,578 | |||||||||
| 66,140 | — | 137,865 | ||||||||||
|
Total stock-based compensation
|
$ | 257,586 | $ | 241,353 | $ | 2,204,999 | ||||||
|
Three and Six
Months Ended
June 30, 2011
|
||||
|
Volatility
|
110 | % | ||
|
Risk-free interest rate
|
1.84% – 3.17 | % | ||
|
Expected life (years)
|
5.5 – 6.25 | |||
|
Dividend
|
0 | % | ||
|
Weighted-average exercise price
|
$ | 1.45 | ||
|
Weighted-average grant-date fair value
|
$ | 1.22 | ||
|
Number of
Shares
Issuable Upon
Exercise of
Outstanding
Options
|
Weighted
Average
Exercise Price
|
Weighted
Average
Remaining
Contracted
Term in
Years
|
Aggregate
Intrinsic
Value
|
|||||||||||||
|
Outstanding at December 31, 2010
|
769,189
|
$
|
2.69
|
|||||||||||||
|
Granted
|
—
|
|||||||||||||||
|
Canceled
|
(769,189
|
)
|
$
|
2.69
|
||||||||||||
|
Outstanding at March 31, 2011
|
—
|
|||||||||||||||
|
Options acquired in connection with a business combination
|
49,159
|
$
|
100.52
|
|||||||||||||
|
Granted
|
3,696,400
|
$
|
1.45
|
|||||||||||||
|
Canceled
|
(12,921
|
)
|
$
|
112.21
|
||||||||||||
|
Forfeited
|
(100,000
|
)
|
$
|
3.00
|
||||||||||||
|
Outstanding at June 30, 2011
|
3,632,638
|
$
|
2.35
|
|||||||||||||
|
Unvested, June 30, 2011
|
3,601,742
|
$
|
1.54
|
9.88
|
$
|
—
|
||||||||||
|
Vested, June 30, 2011
|
30,896
|
$
|
96.59
|
5.78
|
$
|
—
|
||||||||||
|
Exercisable at June 30, 2011
|
30,896
|
$
|
96.59
|
5.78
|
$
|
—
|
||||||||||
|
8.
|
NET LOSS PER SHARE
|
|
Three Months Ended
June 30,
|
Six Months Ended June
30,
|
Cumulative
Development-
Stage Period from
November 7, 2002
(inception)
through June 30,
|
||||||||||||||||||
|
2011
|
2010
|
2011
|
2010
|
2011
|
||||||||||||||||
|
Convertible debt
|
— | 3,448,026 | — | 3,448,026 | — | |||||||||||||||
|
Warrants
|
7,327,322 | — | 7,327,322 | — | 7,327,322 | |||||||||||||||
|
Stock options
|
3,632,638 | 1,133,774 | 3,632,638 | 1,133,774 | 3,632,638 | |||||||||||||||
|
9.
|
INCOME TAXES
|
|
10.
|
RELATED PARTY TRANSACTIONS
|
|
11.
|
LITIGATION
|
|
12.
|
COMMITMENTS
|
|
13.
|
SUPPLEMENTAL PRO FORMA INFORMATION
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
|
2011
|
2010
|
2011
|
2010
|
|||||||||||||
|
Net (loss)
|
$ | (2,006,662 | ) | $ | (3,419,931 | ) | $ | (3,381,503 | ) | $ | (1,238,208 | ) | ||||
|
|
1)
|
Elimination of $14,000 and $96,000 of interest expense for the three months ended June 30, 2011 and 2010, respectively, and $165,000 and $169,000 of interest expense for the six months ended June 30, 2011 and 2010, respectively; such amounts relate to interest accrued on the Convertible Notes which were converted immediately prior to the Acquisition (see Note 4) and the Bank Note which was paid in full settlement of the note immediately prior to the Acquisition (see Note 5).
|
|
|
2)
|
Recognition of a additional BCF of $463,000 in the three and six months ended June 30, 2010 and the elimination of BCF of $258,000 in the three and six months ended June 30, 2011 in connection with the conversion of the Convertible Notes, which is assumed to have occurred on January 1, 2010 for the purpose of pro forma presentation (see Note 4).
|
|
|
3)
|
Elimination of Acquisition costs incurred during the three and six months ended June 30, 2011, respectively, which are assumed to have been incurred prior to January 1, 2010 and the elimination of $450,000 of investment banking fees incurred upon the consummation of the Acquisition on April 8, 2011 from the three and six months ended June 30, 2011 for the purpose of presentation in the pro forma statements of operations.
|
|
|
4)
|
Elimination of dividends and adjustment of deemed dividends on Novelos’ preferred convertible stock, which is assumed to have been exchanged for common stock on January 1, 2010 for the purpose of pro forma presentation. The deemed dividend recorded when the preferred stock was exchanged in November 2010 was recalculated based on fair value assumptions on January 1, 2010, giving effect to the Acquisition.
|
|
14.
|
PROPOSED REVERSE STOCK SPLIT
|
|
Item 2.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
|
Three Months ended June 30,
|
||||||||
|
2011
|
2010
|
|||||||
|
Interest expense, convertible notes
|
$
|
(13,000
|
)
|
$
|
(81,000
|
)
|
||
|
Beneficial conversion feature, convertible notes
|
(258,000
|
)
|
—
|
|||||
|
Interest expense, bank note
|
(1,000
|
)
|
(15,000
|
)
|
||||
|
Interest income
|
1,000
|
5,000
|
||||||
|
$
|
(271,000
|
)
|
$
|
(91,000
|
)
|
|||
|
Six Months Ended June 30,
|
||||||||
|
2011
|
2010
|
|||||||
|
Interest expense, convertible notes
|
$
|
(159,000
|
)
|
$
|
(140,000
|
)
|
||
|
Beneficial conversion feature, convertible notes
|
(258,000
|
)
|
(214,000
|
)
|
||||
|
Interest expense, bank note
|
(6,000
|
)
|
(29,000
|
)
|
||||
|
Interest expense, other
|
(7,000
|
)
|
(1,000
|
)
|
||||
|
Interest income
|
3,000
|
10,000
|
||||||
|
$
|
(427,000
|
)
|
$
|
(374,000
|
)
|
|||
|
Item 4.
|
Controls and Procedures
|
|
Item 1.
|
Legal Proceedings
|
|
|
·
|
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 educating physicians regarding the application and use of our products;
|
|
|
·
|
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.
|
|
·
|
future clinical trial results may show that the cancer-targeting technologies of Cellectar are not well tolerated by recipients at its effective doses or are not efficacious;
|
|
·
|
future clinical trial results may be inconsistent with Cellectar’s previous preliminary testing results and data from Cellectar’s earlier studies may be inconsistent with clinical data;
|
|
·
|
even if the cancer-targeting technologies of Cellectar are shown to be safe and effective for their intended purposes, we may face significant or unforeseen difficulties in obtaining or manufacturing sufficient quantities at reasonable prices or at all;
|
|
·
|
our ability to complete the development and commercialization of the cancer-targeting technologies of Cellectar for our intended use is substantially dependent upon our ability to obtain and maintain experienced and committed partners to assist us with obtaining clinical and regulatory approvals for, and the manufacturing, marketing and distribution of, our products;
|
|
·
|
even if the cancer-targeting technologies of Cellectar are successfully developed, commercially produced and receive all necessary regulatory approvals, there is no guarantee that there will be market acceptance of our products; and
|
|
·
|
our competitors may develop therapeutics or other treatments which are superior or less costly than our own with the result that our product candidates, even if they are successfully developed, manufactured and approved, may not generate sufficient revenues to offset the development and manufacturing costs of our product candidates.
|
|
|
·
|
consolidating research and development operations;
|
|
|
·
|
preserving important research and development, manufacturing and supply, and other relationships;
|
|
|
·
|
minimizing the diversion of management’s attention from ongoing business concerns;
|
|
|
·
|
coordinating geographically separate organizations; and
|
|
|
·
|
optimizing the functioning of a newly constituted Board of Directors.
|
|
|
·
|
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 and other diseases; and
|
|
|
·
|
anticipated expense and time believed to be associated with the development and regulatory approval of treatments for cancer and other diseases.
|
|
|
·
|
receiving regulatory clearance of marketing claims for the uses that we are developing;
|
|
|
·
|
establishing and demonstrating 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.
|
|
|
·
|
announcements or press releases relating to the biopharmaceutical sector or to our own business or prospects;
|
|
|
·
|
regulatory, legislative, or other developments affecting us or the healthcare industry generally;
|
|
|
·
|
sales by holders of restricted securities pursuant to effective registration statements or exemptions from registration; and
|
|
|
·
|
market conditions specific to biopharmaceutical companies, the healthcare industry and the stock market generally.
|
|
|
·
|
the election of directors;
|
|
|
·
|
the amendment of charter documents; and
|
|
|
·
|
the approval of certain mergers and other significant corporate transactions, including a sale of substantially all of our assets.
|
|
|
•
|
provide for the division of our board into three classes as nearly equal in size as possible with staggered three-year terms and further limit the removal of directors and the filling of vacancies;
|
|
|
•
|
authorize our board of directors to issue without stockholder approval blank check preferred stock that, if issued, could operate as a “poison pill” to dilute the stock ownership of a potential hostile acquirer to prevent an acquisition that is not approved by our board of directors;
|
|
|
•
|
require that stockholder actions must be effected at a duly called stockholder meeting and prohibit stockholder action by written consent;
|
|
|
•
|
establish advance notice requirements for stockholder nominations to our board of directors or for stockholder proposals that can be acted on at stockholder meetings;
|
|
|
•
|
limit who may call stockholder meetings; and
|
|
|
•
|
require the approval of the holders of 75% of the outstanding shares of our capital stock entitled to vote in order to amend certain provisions of our restated certificate of incorporation and restated bylaws.
|
|
Item 2.
|
Unregistered Sales of Equity Securities and Use of Proceeds
|
|
Item 3.
|
Defaults Upon Senior Securities
|
|
Item 4.
|
[Removed and Reserved]
|
|
Item 5.
|
Other Information
|
|
Item 6.
|
Exhibits
|
|
Incorporated by Reference
|
||||||||||
|
Exhibit
No.
|
Description
|
Filed with
this
Form 10-Q
|
Form
|
Filing Date
|
Exhibit
No.
|
|||||
|
2.1
|
Agreement and Plan of Merger by and among Novelos Therapeutics, Inc., Cell Acquisition Corp. and Cellectar, Inc. dated April 8, 2011
|
8-K
|
April 11, 2011
|
2.1
|
||||||
|
3.1
|
Second Amended and Restated Certificate of Incorporation
|
8-K
|
April 11, 2011
|
3.1
|
||||||
|
3.2
|
Amended and Restated By-laws
|
8-K
|
June 1, 2011
|
3.1
|
|
Incorporated by Reference
|
||||||||||
|
Exhibit
No.
|
Description
|
Filed with
this
Form 10-Q
|
Form
|
Filing Date
|
Exhibit
No.
|
|||||
|
3.3
|
Form of Certificate of Amendment to the Second Amended and Restated Certificate of Incorporation of Novelos Therapeutics, Inc.
|
S-1
|
July 1, 2011
|
3.3
|
||||||
|
10.1
|
Form of Common Stock Purchase Warrant dated April 8, 2011
|
8-K
|
April 11, 2011
|
4.3
|
||||||
|
10.2
|
Securities Purchase Agreement dated April 8, 2011
|
8-K
|
April 11, 2011
|
10.1
|
||||||
|
10.3
|
Placement Agency Agreement dated April 1, 2011
|
8-K
|
April 11, 2011
|
99.1
|
||||||
|
10.4
|
License Agreement between Cellectar, LLC and the Regents of the University of Michigan dated September 14, 2003, as amended through June 2010
|
S-1
|
July 1, 2011
|
10.31
|
||||||
|
10.5
|
Lease Agreement between Cellectar, LLC and McAllen Properties LLC, as amended and extended to date
|
S-1
|
July 1, 2011
|
10.32
|
||||||
|
10.6
|
Loan Agreement between the Wisconsin Department of Commerce and Cellectar, Inc. dated September 15, 2010
|
S-1
|
July 1, 2011
|
10.33
|
||||||
|
10.7
|
General Business Security Agreement dated September 15, 2010
|
S-1
|
July 1, 2011
|
10.34
|
||||||
|
10.8
|
Amended and Restated 2006 Stock Incentive Plan
|
8-K
|
May 23, 2011
|
10.1
|
||||||
|
10.9
|
Second Amendment to Employment Agreement between the Company and Harry Palmin
|
8-K
|
June 1, 2011
|
10.1
|
||||||
|
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
|
||||||||
| NOVELOS THERAPEUTICS, INC. | ||
|
Date: August 12, 2011
|
By:
|
/s/ Harry S. Palmin
|
|
Harry S. Palmin
|
||
|
President and Chief Executive Officer
|
||
|
Incorporated by Reference
|
||||||||||
|
Exhibit
No.
|
Description
|
Filed with
this
Form 10-Q
|
Form
|
Filing Date
|
Exhibit
No.
|
|||||
|
2.1
|
Agreement and Plan of Merger by and among Novelos Therapeutics, Inc., Cell Acquisition Corp. and Cellectar, Inc. dated April 8, 2011
|
8-K
|
April 11, 2011
|
2.1
|
||||||
|
3.1
|
Second Amended and Restated Certificate of Incorporation
|
8-K
|
April 11, 2011
|
3.1
|
||||||
|
3.2
|
Amended and Restated By-laws
|
8-K
|
June 1, 2011
|
3.1
|
||||||
|
3.3
|
Form of Certificate of Amendment to the Second Amended and Restated Certificate of Incorporation of Novelos Therapeutics, Inc.
|
S-1
|
July 1, 2011
|
3.3
|
||||||
|
10.1
|
Form of Common Stock Purchase Warrant dated April 8, 2011
|
8-K
|
April 11, 2011
|
4.3
|
||||||
|
10.2
|
Securities Purchase Agreement dated April 8, 2011
|
8-K
|
April 11, 2011
|
10.1
|
||||||
|
10.3
|
Placement Agency Agreement dated April 1, 2011
|
8-K
|
April 11, 2011
|
99.1
|
||||||
|
10.4
|
License Agreement between Cellectar, LLC and the Regents of the University of Michigan dated September 14, 2003, as amended through June 2010
|
S-1
|
July 1, 2011
|
10.31
|
||||||
|
10.5
|
Lease Agreement between Cellectar, LLC and McAllen Properties LLC, as amended and extended to date
|
S-1
|
July 1, 2011
|
10.32
|
||||||
|
10.6
|
Loan Agreement between the Wisconsin Department of Commerce and Cellectar, Inc. dated September 15, 2010
|
S-1
|
July 1, 2011
|
10.33
|
||||||
|
10.7
|
General Business Security Agreement dated September 15, 2010
|
S-1
|
July 1, 2011
|
10.34
|
||||||
|
10.8
|
Amended and Restated 2006 Stock Incentive Plan
|
8-K
|
May 23, 2011
|
10.1
|
||||||
|
10.9
|
Second Amendment to Employment Agreement between the Company and Harry Palmin
|
8-K
|
June 1, 2011
|
10.1
|
||||||
|
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
|
||||||||
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|