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Delaware
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91-1707622
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(State or Other Jurisdiction
of Incorporation or Organization) |
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(I.R.S. Employer
Identification No.) |
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200 Connell Drive
Suite 1500 Berkeley Heights, New Jersey |
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07922
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(Address of principal executive offices)
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(Zip Code)
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Title of each class
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Name of each exchange on which registered
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Common Stock, $0.001 par value
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The NASDAQ Stock Market LLC
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Preferred Stock, $0.001 par value
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The NASDAQ Stock Market LLC
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Large accelerated filer ☐
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Accelerated filer ☐
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Non-accelerated filer ☐
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Smaller reporting company ☒
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[Do not check if a smaller reporting company]
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Page
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PART I
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| | | | 1 | | | |
| | | | 19 | | | |
| | | | 45 | | | |
| | | | 45 | | | |
| | | | 46 | | | |
| | | | 46 | | | |
PART II
|
| | |||||
| | | | 47 | | | |
| | | | 47 | | | |
| | | | 47 | | | |
| | | | 56 | | | |
| | | | 57 | | | |
| | | | 83 | | | |
| | | | 83 | | | |
| | | | 84 | | | |
PART III
|
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| | | | 85 | | | |
| | | | 85 | | | |
| | | | 85 | | | |
| | | | 85 | | | |
| | | | 85 | | | |
PART IV
|
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| | | | 86 | | |
Program
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Indication
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Development Status
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Target
|
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Cell Cycle
Mechanism |
|
Oncology | | | | | | ||||||||
Sapacitabine, CYC682 | | |
Elderly AML
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Phase 3 registration study
on-going. Enrollment completed |
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DNA polymerase
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G2 and S phase
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Sapacitabine, CYC682 | | |
MDS
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Phase 2 randomized trial
Enrollment completed |
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DNA polymerase
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G2 and S phase
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Seliciclib + Sapacitabine
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Cancer
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Phase 1 trial on-going
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CYC065 CDK inhibitor
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Cancer
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Phase 1 first-in-human
solid tumors and lymphoma; on-going |
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CDK2/9
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G1/S
checkpoint and others |
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CYC140 PLK inhibitor | | |
Cancer
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Preclinical
|
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PLK1
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G2/M
checkpoint |
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Investigator Sponsored Trials |
| | | | | ||||||||
Seliciclib, CYC202 | | |
Cushing’s disease and
rheumatoid arthritis |
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Phase 2 trial
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CDK2/9
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G1/S
checkpoint and others |
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Licensing & Collaboration | | | | | | ||||||||
Seliciclib, CYC202 | | |
Cancer
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Phase 2 trial
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| | |
High
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Low
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2015 | | | | ||||||||||
Quarter ended March 31, 2015
|
| | | $ | 2.13 | | | | | $ | 0.51 | | |
Quarter ended June 30, 2015
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| | | $ | 1.10 | | | | | $ | 0.68 | | |
Quarter ended September 30, 2015
|
| | | $ | 0.80 | | | | | $ | 0.49 | | |
Quarter ended December 31, 2015
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| | | $ | 1.05 | | | | | $ | 0.47 | | |
2014 | | | | ||||||||||
Quarter ended March 31, 2014
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| | | $ | 4.84 | | | | | $ | 3.19 | | |
Quarter ended June 30, 2014
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| | | $ | 3.87 | | | | | $ | 2.88 | | |
Quarter ended September 30, 2014
|
| | | $ | 3.58 | | | | | $ | 2.90 | | |
Quarter ended December 31, 2014
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| | | $ | 3.72 | | | | | $ | 0.61 | | |
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Years Ended December 31,
|
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Difference
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| | |
2014
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2015
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$
|
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%
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Grant revenue
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| | | $ | 1,734 | | | | | $ | 1,694 | | | | | | (40) | | | | | | (2) | | |
Collaboration and research and development revenue
|
| | | | — | | | | | | 250 | | | | | | 250 | | | | | | — | | |
Total Revenue
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| | | $ | 1,734 | | | | | $ | 1,944 | | | | | | 210 | | | | | | 12 | | |
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| | |
Years Ended December 31,
|
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Difference
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| ||||||||||||||||||
| | |
2014
|
| |
2015
|
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$
|
| |
%
|
| ||||||||||||
Sapacitabine
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| | | $ | 14,757 | | | | | $ | 8,228 | | | | | | (6,529) | | | | | | (44) | | |
Other costs related to research and development programs and management
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| | | | 3,520 | | | | | | 4,154 | | | | | | 634 | | | | | | 18 | | |
Total research and development
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| | | $ | 18,277 | | | | | $ | 12,382 | | | | | | (5,895) | | | | | | (32) | | |
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Years Ended December 31,
|
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Difference
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| ||||||||||||||||||
| | |
2014
|
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2015
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$
|
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%
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| ||||||||||||
General and administrative
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| | | $ | 5,894 | | | | | $ | 5,732 | | | | | | (162) | | | | | | (3) | | |
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Years Ended December 31,
|
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Difference
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| ||||||||||||||||||
| | |
2014
|
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2015
|
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$
|
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%
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| ||||||||||||
Change in valuation of financial instruments associated with stock purchase agreement
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| | | $ | (342) | | | | | $ | (51) | | | | | | 291 | | | | | | (85) | | |
Change in valuation of liabilities measured at fair value
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| | | | 20 | | | | | | — | | | | | | (20) | | | | | | (100) | | |
Foreign exchange gains (losses)
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| | | | (10) | | | | | | (368) | | | | | | (358) | | | | | | 3,580 | | |
Interest income
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| | | | 6 | | | | | | 9 | | | | | | 3 | | | | | | 50 | | |
Other income, net
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| | | | 114 | | | | | | 94 | | | | | | (20) | | | | | | (18) | | |
Total other income (expense), net
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| | | $ | (212) | | | | | $ | (316) | | | | | | (104) | | | | | | 49 | | |
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Years Ended December 31,
|
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Difference
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| | |
2014
|
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2015
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$
|
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%
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| ||||||||||||
Income tax benefit
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| | | $ | 3,243 | | | | | $ | 2,144 | | | | | | (1,099) | | | | | | (34) | | |
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Years Ended December 31,
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Difference
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| | |
2014
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2015
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$
|
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%
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Income from discontinued operations
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| | | $ | 29 | | | | | $ | — | | | | | | (29) | | | | | | (100) | | |
Income tax on discontinued operations
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| | | | (10) | | | | | | — | | | | | | 10 | | | | | | (100) | | |
Net income from discontinued operations
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| | | $ | 19 | | | | | $ | — | | | | | | (19) | | | | | | (100) | | |
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December 31, 2014
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December 31, 2015
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Cash and cash equivalents
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| | | $ | 24,189 | | | | | $ | 20,440 | | |
Working capital: | | | | ||||||||||
Current assets
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| | | $ | 29,000 | | | | | $ | 24,566 | | |
Current liabilities
|
| | | | (7,493) | | | | | | (5,753) | | |
Total working capital
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| | | $ | 21,507 | | | | | $ | 18,813 | | |
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Years Ended December 31,
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2014
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2015
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Net cash used in operating activities
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| | | $ | (18,702) | | | | | $ | (14,460) | | |
Net cash provided by investing activities
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| | | $ | 75 | | | | | $ | 62 | | |
Net cash provided by financing activities
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| | | $ | 12,200 | | | | | $ | 10,860 | | |
Cash flows from discontinued operations | | | | ||||||||||
Net cash provided by investing activities
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| | | $ | 384 | | | | | $ | 96 | | |
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Page
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| | | | 58 | | | |
| | | | 59 | | | |
| | | | 60 | | | |
| | | | 61 | | | |
| | | | 62 | | | |
| | | | 63 | | | |
| | | | 64 | | |
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December 31,
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2014
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2015
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ASSETS | | | | ||||||||||
Current assets: | | | | ||||||||||
Cash and cash equivalents
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| | | $ | 24,189 | | | | | $ | 20,440 | | |
Prepaid expenses and other current assets
|
| | | | 4,640 | | | | | | 4,051 | | |
Current assets of discontinued operations
|
| | | | 171 | | | | | | 75 | | |
Total current assets
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| | | | 29,000 | | | | | | 24,566 | | |
Property, plant and equipment (net)
|
| | | | 387 | | | | | | 198 | | |
Long-term assets of discontinued operations
|
| | | | — | | | | | | — | | |
Total assets
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| | | $ | 29,387 | | | | | $ | 24,764 | | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | | | | ||||||||||
Current liabilities: | | | | ||||||||||
Accounts payable
|
| | | $ | 2,792 | | | | | $ | 1,940 | | |
Accrued and other current liabilities
|
| | | | 4,626 | | | | | | 3,738 | | |
Other liabilities measured at fair value
|
| | | | — | | | | | | — | | |
Current liabilities of discontinued operations
|
| | | | 75 | | | | | | 75 | | |
Total current liabilities
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| | | | 7,493 | | | | | | 5,753 | | |
Other liabilities | | | | | 206 | | | | | | 176 | | |
Total liabilities
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| | | | 7,699 | | | | | | 5,929 | | |
Commitments and contingencies
|
| | | | — | | | | |||||
Stockholders’ equity: | | | | ||||||||||
Preferred stock, $0.001 par value; 5,000,000 shares authorized at December 31,
2014 and 2015; 335,273 shares issued and outstanding at December 31, 2014 and 2015. Aggregate preference in liquidation of $3,989,749 at December 31, 2014 and 2015 |
| | | | — | | | | | | — | | |
Common stock, $0.001 par value; 100,000,000 shares authorized at December 31, 2014 and 2015; 23,199,469 and 35,582,492 shares issued and outstanding at December 31, 2014 and 2015, respectively
|
| | | | 23 | | | | | | 35 | | |
Additional paid-in capital
|
| | | | 330,962 | | | | | | 342,555 | | |
Accumulated other comprehensive income (loss)
|
| | | | (480) | | | | | | (596) | | |
Accumulated deficit
|
| | | | (308,817) | | | | | | (323,159) | | |
Total stockholders’ equity
|
| | | | 21,688 | | | | | | 18,835 | | |
Total liabilities and stockholders’ equity
|
| | | $ | 29,387 | | | | | $ | 24,764 | | |
|
| | |
Year Ended
December 31, 2014 |
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Year Ended
December 31, 2015 |
| ||||||
Revenues: | | | | ||||||||||
Grant revenue
|
| | | $ | 1,734 | | | | | $ | 1,694 | | |
Collaboration and research and development revenue
|
| | | | — | | | | | | 250 | | |
Total revenues
|
| | | | 1,734 | | | | | | 1,944 | | |
Operating expenses: | | | | ||||||||||
Research and development
|
| | | | 18,277 | | | | | | 12,382 | | |
General and administrative
|
| | | | 5,894 | | | | | | 5,732 | | |
Total operating expenses
|
| | | | 24,171 | | | | | | 18,114 | | |
Operating loss
|
| | | | (22,437) | | | | | | (16,170) | | |
Other income (expense): | | | | ||||||||||
Change in valuation of financial instruments associated with stock purchase agreement
|
| | | | (342) | | | | | | (51) | | |
Change in valuation of liabilities measured at fair value
|
| | | | 20 | | | | | | — | | |
Foreign exchange gains
|
| | | | (10) | | | | | | (368) | | |
Interest income
|
| | | | 6 | | | | | | 9 | | |
Other income, net
|
| | | | 114 | | | | | | 94 | | |
Total other income (expense), net
|
| | | | (212) | | | | | | (316) | | |
Loss from continuing operations before taxes
|
| | | | (22,649) | | | | | | (16,486) | | |
Income tax benefit
|
| | | | 3,243 | | | | | | 2,144 | | |
Net loss from continuing operations
|
| | | | (19,406) | | | | | | (14,342) | | |
Discontinued operations: | | | | ||||||||||
Income from discontinued operations
|
| | | | 29 | | | | | | — | | |
Income tax on discontinued operations
|
| | | | (10) | | | | | | — | | |
Net income from discontinued operations
|
| | | | 19 | | | | | | — | | |
Net loss
|
| | | | (19,387) | | | | | | (14,342) | | |
Deemed dividend on convertible exchangeable preferred shares
|
| | | | — | | | | | | — | | |
Dividend on convertible exchangeable preferred shares
|
| | | | (200) | | | | | | (201) | | |
Net loss applicable to common shareholders
|
| | | $ | (19,587) | | | | | $ | (14,543) | | |
Basic and diluted earnings per common share: | | | | ||||||||||
Net loss per share, continuing operations – basic and diluted
|
| | | $ | (0.89) | | | | | $ | (0.45) | | |
Net income per share, discontinued operations – basic and diluted
|
| | | $ | 0.00 | | | | | $ | 0.00 | | |
Net loss per share – basic and diluted
|
| | | $ | (0.89) | | | | | $ | (0.45) | | |
Weighted average common shares outstanding
|
| | | | 21,955,381 | | | | | | 32,557,146 | | |
|
| | |
Year Ended
December 31, 2014 |
| |
Year Ended
December 31, 2015 |
| ||||||
Net loss from continuing operations
|
| | | $ | (19,406) | | | | | $ | (14,342) | | |
Net income from discontinued operations, net of tax
|
| | | | 19 | | | | | | — | | |
Net loss
|
| | | | (19,387) | | | | | | (14,342) | | |
Translation adjustment
|
| | | | 8,020 | | | | | | 6,420 | | |
Unrealized foreign exchange loss on intercompany loans
|
| | | | (8,391) | | | | | | (6,536) | | |
Comprehensive loss
|
| | | $ | (19,758) | | | | | $ | (14,458) | | |
|
| | |
Preferred Stock
|
| |
Common Stock
|
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Additional
paid-in capital |
| |
Accumulated
other comprehensive income/(loss) |
| |
Accumulated
Deficit |
| |
Total
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| | |
No.
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Amount
|
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No.
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| |
Amount
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| | | | | ||||||||||||||||||||||||||||||||
Balance at December 31, 2013
|
| | | | 335,273 | | | | | $ | — | | | | | | 19,369,332 | | | | | $ | 19 | | | | | $ | 317,543 | | | | | $ | (109) | | | | | $ | (289,430) | | | | | $ | 28,023 | | |
Issue of common stock for cash
on registered direct offering, net of expenses |
| | | | — | | | | | | — | | | | | | 2,857,143 | | | | | | 3 | | | | | | 9,286 | | | | | | — | | | | | | — | | | | | | 9,289 | | |
Issue of common stock on share purchase agreement
|
| | | | — | | | | | | — | | | | | | 950,000 | | | | | | 1 | | | | | | 3,131 | | | | | | — | | | | | | — | | | | | | 3,132 | | |
Stock-based awards exercised
|
| | | | — | | | | | | — | | | | | | 22,994 | | | | | | — | | | | | | (21) | | | | | | — | | | | | | — | | | | | | (21) | | |
Stock-based compensation
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 1,223 | | | | | | — | | | | | | — | | | | | | 1,223 | | |
Preferred stock dividends
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (200) | | | | | | — | | | | | | — | | | | | | (200) | | |
Unrealized foreign exchange on intercompany loans
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (8,391) | | | | | | — | | | | | | (8,391) | | |
Translation adjustment
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 8,020 | | | | | | — | | | | | | 8,020 | | |
Loss for the year
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (19,387) | | | | | | (19,387) | | |
Balance at December 31, 2014
|
| | | | 335,273 | | | | | $ | — | | | | | | 23,199,469 | | | | | $ | 23 | | | | | $ | 330,962 | | | | | $ | (480) | | | | | $ | (308,817) | | | | | $ | 21,688 | | |
Issue of common stock for cash
on registered direct offering, net of expenses |
| | | | — | | | | | | — | | | | | | 10,000,000 | | | | | | 10 | | | | | | 9,161 | | | | | | | | | | | | | | | | | | 9,171 | | |
Issue of common stock upon draw down of Committed Equity
Finance Facility |
| | | | — | | | | | | — | | | | | | 879,583 | | | | | | 1 | | | | | | 483 | | | | | | — | | | | | | — | | | | | | 484 | | |
Issue of common stock on share purchase agreement
|
| | | | — | | | | | | — | | | | | | 1,414,424 | | | | | | 1 | | | | | | 1,405 | | | | | | — | | | | | | — | | | | | | 1,406 | | |
Stock-based awards vested
|
| | | | — | | | | | | — | | | | | | 89,016 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | |||||
Stock-based compensation
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 745 | | | | | | — | | | | | | — | | | | | | 745 | | |
Preferred stock dividends
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (201) | | | | | | — | | | | | | — | | | | | | (201) | | |
Unrealized foreign exchange on intercompany loans
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (6,536) | | | | | | — | | | | | | (6,536) | | |
Translation adjustment
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 6,420 | | | | | | — | | | | | | 6,420 | | |
Loss for the year
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (14,342) | | | | | | (14,342) | | |
Balance at December 31, 2015
|
| | | | 335,273 | | | | | $ | — | | | | | | 35,582,492 | | | | | $ | 35 | | | | | $ | 342,555 | | | | | $ | (596) | | | | | $ | (323,159) | | | | | $ | 18,835 | | |
|
| | |
Year Ended
December 31, 2014 |
| |
Year Ended
December 31, 2015 |
| ||||||
Operating activities: | | | | ||||||||||
Net loss
|
| | | $ | (19,387) | | | | | $ | (14,342) | | |
Change in valuation of liabilities at fair value
|
| | | | (20) | | | | | | — | | |
Change in valuation of financial instruments associated with stock
purchase agreement |
| | | | 342 | | | | | | 51 | | |
Depreciation
|
| | | | 174 | | | | | | 210 | | |
Stock-based compensation
|
| | | | 1,223 | | | | | | 745 | | |
Changes in operating assets and liabilities: | | | | ||||||||||
Prepaid expenses and other assets
|
| | | | (1,700) | | | | | | 342 | | |
Accounts payable and other current liabilities
|
| | | | 666 | | | | | | (1,466) | | |
Net cash used in operating activities
|
| | | | (18,702) | | | | | | (14,460) | | |
Investing activities: | | | | ||||||||||
Purchase of property, plant and equipment
|
| | | | (309) | | | | | | (34) | | |
Minimum royalty payments received from termination of ALIGN license agreement
|
| | | | 384 | | | | | | 96 | | |
Net cash provided by investing activities
|
| | | | 75 | | | | | | 62 | | |
Financing activities: | | | | ||||||||||
Proceeds from issuance of common stock and warrants, net of issuance
costs |
| | | | 12,421 | | | | | | 11,061 | | |
Proceeds from the exercise of stock options and warrants, net of issuance costs
|
| | | | (21) | | | | | | — | | |
Payment of preferred stock dividend
|
| | | | (200) | | | | | | (201) | | |
Net cash provided by financing activities
|
| | | | 12,200 | | | | | | 10,860 | | |
Effect of exchange rate changes on cash and cash equivalents
|
| | | | (530) | | | | | | (211) | | |
Net decrease in cash and cash equivalents
|
| | | | (6,957) | | | | | | (3,749) | | |
Cash and cash equivalents, beginning of period
|
| | | | 31,146 | | | | | | 24,189 | | |
Cash and cash equivalents, end of period
|
| | | $ | 24,189 | | | | | $ | 20,440 | | |
Supplemental cash flow information: | | | | ||||||||||
Cash received during the period for: | | | | ||||||||||
Interest
|
| | | | 6 | | | | | | 10 | | |
Taxes
|
| | | | 1,811 | | | | | | 2,861 | | |
Cash flow from discontinued operations: | | | | ||||||||||
Net cash provided by investing activities
|
| | | | 384 | | | | | | 96 | | |
Non cash financing activities: | | | | ||||||||||
Accrual of preferred stock dividends
|
| | | | 50 | | | | | | 50 | | |
| | |
Year Ended
December 31, 2014 |
| |
Year Ended
December 31, 2015 |
| ||||||
Stock options
|
| | | | 1,010,298 | | | | | | 2,475,579 | | |
Restricted Stock Units
|
| | | | 89,016 | | | | | | — | | |
Convertible preferred stock
|
| | | | 20,381 | | | | | | 20,381 | | |
Common stock warrants
|
| | | | 1,341,129 | | | | | | 544,117 | | |
Total shares excluded from calculation
|
| | | | 2,460,824 | | | | | | 3,040,077 | | |
|
| | |
December 31,
|
| |||||||||
| | |
2014
|
| |
2015
|
| ||||||
Cash
|
| | | $ | 5,870 | | | | | $ | 8,487 | | |
Investments with original maturity of less than three months at the time
of purchase |
| | | | 18,319 | | | | | | 11,953 | | |
Total cash and cash equivalents
|
| | | $ | 24,189 | | | | | $ | 20,440 | | |
|
| | |
Level 1
|
| |
Level 2
|
| |
Level 3
|
| |
Total
|
| ||||||||||||
ASSETS | | | | | | ||||||||||||||||||||
Cash equivalents
|
| | | $ | 18,319 | | | | | $ | — | | | | | $ | — | | | | | $ | 18,319 | | |
Financial instrument associated with stock purchase agreement
|
| | | | — | | | | | | 51 | | | | | | — | | | | | | 51 | | |
Total assets
|
| | | $ | 18,319 | | | | | $ | 51 | | | | | $ | — | | | | | $ | 18,370 | | |
|
| | |
Level 1
|
| |
Level 2
|
| |
Level 3
|
| |
Total
|
| ||||||||||||
ASSETS | | | | | | ||||||||||||||||||||
Cash equivalents
|
| | | $ | 11,953 | | | | | $ | — | | | | | $ | — | | | | | $ | 11,953 | | |
Total assets
|
| | | $ | 11,953 | | | | | $ | — | | | | | $ | — | | | | | $ | 11,953 | | |
|
| | |
December 31,
|
| |||||||||
| | |
2014
|
| |
2015
|
| ||||||
Research and development tax credit receivable
|
| | | $ | 3,017 | | | | | $ | 2,093 | | |
Prepayments
|
| | | | 902 | | | | | | 893 | | |
Grant receivable
|
| | | | 134 | | | | | | 326 | | |
VAT receivable
|
| | | | 309 | | | | | | 607 | | |
Deposits
|
| | | | 132 | | | | | | 132 | | |
Other current assets
|
| | | | 146 | | | | | | — | | |
| | | | $ | 4,640 | | | | | $ | 4,051 | | |
|
| | |
Useful lives in
years from date of acquisition |
| |
December 31,
|
| |||||||||
| | |
2014
|
| |
2015
|
| |||||||||
Leasehold improvements
|
| |
5 to 15 years
|
| | | $ | 914 | | | | | $ | 885 | | |
Research and laboratory equipment
|
| |
3 to 5 years
|
| | | | 5,881 | | | | | | 5,604 | | |
Office equipment and furniture
|
| |
3 to 5 years
|
| | | | 1,302 | | | | | | 1,294 | | |
| | | | | | | | 8,097 | | | | | | 7,783 | | |
Less: accumulated depreciation and amortization
|
| | | | | | | (7,710) | | | | | | (7,585) | | |
| | | | | | | $ | 387 | | | | | $ | 198 | | |
|
| | |
December 31,
|
| |||||||||
| | |
2014
|
| |
2015
|
| ||||||
Accrued research and development
|
| | | $ | 4,161 | | | | | $ | 3,284 | | |
Accrued legal and professional fees
|
| | | | 303 | | | | | | 291 | | |
Other current liabilities
|
| | | | 162 | | | | | | 163 | | |
| | | | $ | 4,626 | | | | | $ | 3,738 | | |
|
| | |
Operating
Lease Obligations |
| |||
2016
|
| | | $ | 537 | | |
2017
|
| | | | 408 | | |
2018
|
| | | | 381 | | |
2019
|
| | | | 373 | | |
2020
|
| | | | 373 | | |
Thereafter
|
| | | | 1,795 | | |
Total
|
| | | $ | 3,867 | | |
|
Issued in Connection With
|
| |
Expiration
Date |
| |
Common
Shares Issuable |
| |
Weighted
Average Exercise Price |
| |||||||||
July 2011 stock issuance
|
| | | | 2016 | | | | | | 544,117 | | | | | $ | 9.52 | | |
Total
|
| | | | | | | | | | 544,117 | | | | | $ | 9.52 | | |
|
| | |
Year Ended
December 31, 2014 |
| |
Year Ended
December 31, 2015 |
| ||||||
Research and development
|
| | | $ | 392 | | | | | $ | 240 | | |
General and administrative
|
| | | | 831 | | | | | | 505 | | |
Stock-based compensation costs before income taxes
|
| | | $ | 1,223 | | | | | $ | 745 | | |
|
| | |
Number of
Options Outstanding |
| |
Weighted
Average Exercise Price Per Share |
| |
Weighted
Average Remaining Contractual Term (Years) |
| |
Aggregate
Intrinsic Value ($000s) |
| ||||||||||||
Options outstanding at December 31, 2013
|
| | | | 949,685 | | | | | $ | 15.02 | | | | | | 7.38 | | | | | $ | 152 | | |
Granted
|
| | | | 63,000 | | | | | $ | 3.11 | | | | | ||||||||||
Exercised
|
| | | | — | | | | | | |||||||||||||||
Cancelled/forfeited
|
| | | | (2,387) | | | | | $ | 31.08 | | | | | ||||||||||
Options outstanding at December 31, 2014
|
| | | | 1,010,298 | | | | | $ | 14.24 | | | | | | 6.58 | | | | | $ | — | | |
Granted
|
| | | | 1,470,281 | | | | | $ | 0.63 | | | | | ||||||||||
Exercised
|
| | | | — | | | | | | |||||||||||||||
Cancelled/forfeited
|
| | | | (5,000) | | | | | $ | 67.82 | | | | | ||||||||||
Options outstanding at December 31, 2015
|
| | | | 2,475,579 | | | | | $ | 6.05 | | | | | | 8.09 | | | | | | — | | |
Unvested at December 31, 2015
|
| | | | 1,577,211 | | | | | $ | 1.01 | | | | | | 9.61 | | | | | $ | — | | |
Vested and exercisable at December 31, 2015
|
| | | | 898,368 | | | | | $ | 14.91 | | | | | | 5.42 | | | | | $ | — | | |
|
| | |
Year ended
December 31, 2014 |
| |
Year ended
December 31, 2015 |
|
Expected term (years)
|
| |
6
|
| |
5-6
|
|
Risk free interest rate
|
| |
1.835% – 2.005%
|
| |
1.520% – 1.845%
|
|
Volatility
|
| |
101%
|
| |
96% – 108%
|
|
Expected dividend yield over expected term
|
| |
0.00%
|
| |
0.00%
|
|
Resulting weighted average grant date fair value
|
| |
$2.48
|
| |
$0.51
|
|
| | |
Restricted
Stock Units |
| |
Weighted
Average Grant Date Value Per Share |
| ||||||
Non-vested at December 31, 2013
|
| | | | 119,248 | | | | | $ | 5.62 | | |
Granted
|
| | | | — | | | | | $ | — | | |
Vested
|
| | | | (29,999) | | | | | $ | 5.81 | | |
Forfeited
|
| | | | (233) | | | | | $ | 5.39 | | |
Non-vested at December 31, 2014
|
| | | | 89,016 | | | | | $ | 5.56 | | |
Vested
|
| | | | (89,016) | | | | | $ | 5.56 | | |
Non-vested at December 31, 2015
|
| | | | — | | | | | | — | | |
|
| | |
Year ended
December 31, 2014 |
| |
Year ended
December 31, 2015 |
| ||||||
Interest income
|
| | | $ | 29 | | | | | $ | — | | |
Income tax on discontinued operations
|
| | | | (10) | | | | | | — | | |
Net income from discontinued operations, net of tax
|
| | | $ | 19 | | | | | $ | — | | |
|
| | |
December 31,
2014 |
| |
December 31,
2015 |
| ||||||
Current assets of discontinued operations: | | | | ||||||||||
Short term portion of minimum royalty arrangement receivable, net
|
| | | $ | 96 | | | | | $ | — | | |
Returns indemnification receivable
|
| | | | 75 | | | | | | 75 | | |
Total current assets of discontinued operations
|
| | | | 171 | | | | | | 75 | | |
Long-term assets of discontinued operations: | | | | ||||||||||
Long-term portion of minimum royalty arrangement receivable, net
|
| | | | — | | | | | | — | | |
Total assets of discontinued operations
|
| | | $ | 171 | | | | | $ | 75 | | |
Current liabilities of discontinued operations: | | | | ||||||||||
Returns provision
|
| | | $ | 75 | | | | | $ | 75 | | |
Total current liabilities of discontinued operations
|
| | | $ | 75 | | | | | $ | 75 | | |
|
| | |
Year Ended
December 31, 2014 |
| |
Year Ended
December 31, 2015 |
| ||||||
Domestic
|
| | | $ | (2,898) | | | | | $ | (2,520) | | |
Foreign
|
| | | | (19,751) | | | | | | (13,966) | | |
Loss from continuing operations before taxes
|
| | | $ | (22,649) | | | | | $ | (16,486) | | |
|
| | |
Year Ended
December 31, 2014 |
| |
Year Ended
December 31, 2015 |
| ||||||
Current – domestic
|
| | | $ | 34 | | | | | $ | — | | |
Current – foreign
|
| | | | 3,209 | | | | | | 2,144 | | |
Current – total
|
| | | | 3,243 | | | | | | 2,144 | | |
Deferred – domestic
|
| | | | — | | | | | | — | | |
Income tax benefit
|
| | | $ | 3,243 | | | | | $ | 2,144 | | |
|
| | |
Year Ended
December 31, 2014 |
| |
Year Ended
December 31, 2015 |
| ||||||
Loss from continuing operations before taxes
|
| | | $ | (22,649) | | | | | $ | (16,486) | | |
Income tax expense computed at statutory federal tax rate
|
| | | | (7,701) | | | | | | (5,605) | | |
Disallowed expenses and non-taxable income
|
| | | | 406 | | | | | | 27 | | |
Loss surrendered to generate R&D credit
|
| | | | 7,294 | | | | | | 2,479 | | |
Additional research and development tax relief
|
| | | | (7,262) | | | | | | (3,402) | | |
Change in valuation allowance
|
| | | | (4,963) | | | | | | (4,189) | | |
Research and development credit – prior years
|
| | | | — | | | | | | — | | |
Foreign items, including change in tax rates, and other
|
| | | | 3,555 | | | | | | 6,882 | | |
Other foreign items
|
| | | | 5,428 | | | | | | 1,664 | | |
| | | | $ | (3,243) | | | | | $ | (2,144) | | |
|
| | |
December 31,
|
| |||||||||
| | |
2014
|
| |
2015
|
| ||||||
Net operating loss carryforwards
|
| | | $ | 45,060 | | | | | $ | 41,003 | | |
Depreciation, amortization and impairment of property and equipment
|
| | | | 81 | | | | | | 101 | | |
Stock options
|
| | | | 1,815 | | | | | | 2,193 | | |
Accrued expenses
|
| | | | 179 | | | | | | — | | |
Research and development credits
|
| | | | 4,332 | | | | | | 4,021 | | |
Other
|
| | | | 78 | | | | | | 38 | | |
Translation adjustment
|
| | | | — | | | | | | — | | |
Deferred tax assets
|
| | | | 51,545 | | | | | | 47,356 | | |
Valuation allowance for deferred tax assets
|
| | | | (51,545) | | | | | | (47,356) | | |
Net deferred taxes
|
| | | $ | — | | | | | $ | — | | |
|
| | |
Year Ended
December 31, 2014 |
| |
Year Ended
December 31, 2015 |
| ||||||
Revenue | | | | ||||||||||
United Kingdom
|
| | | $ | 1,734 | | | | | $ | 1,944 | | |
Total Revenue
|
| | | | 1,734 | | | | | | 1,944 | | |
Net loss | | | | ||||||||||
United States:
|
| | | ||||||||||
Continuing operations
|
| | | | (2,865) | | | | | | (2,520) | | |
Discontinued operations
|
| | | | 19 | | | | | | — | | |
Total United States
|
| | | | (2,846) | | | | | | (2,520) | | |
United Kingdom
|
| | | | (16,541) | | | | | | (11,822) | | |
Total Net Loss
|
| | | $ | (19,387) | | | | | $ | (14,342) | | |
|
| | |
December 31,
|
| |||||||||
| | |
2014
|
| |
2015
|
| ||||||
Total Assets | | | | ||||||||||
United States:
|
| | | ||||||||||
Continuing operations
|
| | | $ | 18,923 | | | | | $ | 17,124 | | |
Discontinued operations
|
| | | | 171 | | | | | | 75 | | |
Total United States
|
| | | | 19,094 | | | | | | 17,199 | | |
United Kingdom
|
| | | | 10,293 | | | | | | 7,565 | | |
Total Assets
|
| | | | 29,387 | | | | | | 24,764 | | |
Long Lived Assets, net | | | | ||||||||||
United States:
|
| | | ||||||||||
Continuing operations
|
| | | | 6 | | | | | | 4 | | |
Discontinued operations
|
| | | | — | | | | | | — | | |
Total United States
|
| | | | 6 | | | | |||||
United Kingdom
|
| | | | 381 | | | | | | 194 | | |
Total Long Lived Assets, net
|
| | | $ | 387 | | | | | $ | 198 | | |
|
EXHIBIT NUMBER |
| |
DESCRIPTION
|
|
1.1 | | | Engagement Letter, dated March 3, 2015, by and between Cyclacel Pharmaceuticals, Inc. and H.C. Wainwright & Co., LLC (previously filed Exhibit 1.1 to the Registrant’s Current Report on Form 8-K, originally filed with the SEC on March 4, 2015, and incorporated herein by reference). | |
1.2 | | | Controlled Equity Offering Sales Agreement, dated July 10, 2015, by and among the Company and Cantor Fitzgerald & Co. (previously filed as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, originally field with the SEC on July 10, 2015, and incorporated herein by reference). | |
3.2 | | | Amended and Restated Bylaws of Cyclacel Pharmaceuticals, Inc. (Previously filed as Exhibit 3.2 to the Registrant’s Annual Report on Form 10-K, File No. 000-50626, originally filed with the SEC on March 31, 2011 and incorporated herein by reference). | |
3.3 | | | Preferred Stock Certificate of Designations (previously filed as Exhibit 3.2 to the Registrant’s Current Report on Form 8-K, originally filed with the SEC on November 5, 2004, and incorporated herein by reference). | |
4.1 | | | Specimen of Common Stock Certificate (previously filed as Exhibit 4.1 to Registrant’s Registration Statement on Form S-1, File No. 333-109653, originally filed with the SEC on October 10, 2003, as subsequently amended, and incorporated herein by reference). | |
4.2 | | | Specimen of Preferred Stock Certificate of Designation (previously filed as Exhibit 3.2 to Registrant’s Registration Statement on Form S-1, File No. 333-119585, originally filed with the SEC on October 7, 2004, as subsequently amended, and incorporated herein by reference). | |
4.3 | | | Form of Warrant to purchase shares of Cyclacel Pharmaceuticals, Inc. Common Stock (previously filed as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, originally filed with the SEC on July 1, 2011, and incorporated herein by reference). | |
4.4 | | | Registration Rights Agreement, dated as of December 14, 2012, by and between the Company and Aspire Capital Fund, LLC (previously filed as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, originally filed with the SEC on December 17, 2012, and incorporated herein by reference). | |
4.5 | | | Registration Rights Agreement, dated November 14, 2013, by and between the Company and Aspire Capital Fund, LLC (previously filed as Exhibit 4.1 to the Registrant’s Quarterly Report on Form 10-Q, originally filed with the SEC on November 14, 2013, and incorporated herein by reference). | |
10.1 | | | Stock Purchase Agreement, dated December 15, 2005, between Xcyte Therapies, Inc., and Cyclacel Group plc (previously filed as Exhibit 2.1 to the Registrant’s Current Report on Form 8-K, originally filed with the SEC on December 20, 2005, and incorporated herein by reference). | |
EXHIBIT NUMBER |
| |
DESCRIPTION
|
|
10.2 | | | Amendment No. 1 to the Stock Purchase Agreement, dated January 13, 2006, between Xcyte Therapies Inc., and Cyclacel Group plc (previously filed as exhibit 2.1 to the Registrant’s current report on Form 8-K filed with the Commission on January 19, 2006, and incorporated herein by reference). | |
10.3† | | | Amended and Restated Equity Incentive Plan (previously filed as Exhibit 10.1 to Registrant’s Current Report on Form 8-K, originally filed with the SEC on May 24, 2012, and incorporated by reference). | |
10.4† | | | Equity Incentive Plan (previously filed as Exhibit 10.1 to Registrant’s Current Report on Form 8-K, originally filed with the SEC on May 22, 2015, and incorporated by reference). | |
10.5† | | | Employment Agreement by and between Cyclacel Pharmaceuticals, Inc. and Spiro Rombotis, dated as of January 1, 2014 (previously filed as Exhibit 10.4 to the Registrant’s Annual Report on Form 10-K, originally filed with the SEC on March 24, 2014, and incorporated by reference). | |
10.6† | | | Employment Agreement by and between Cyclacel Pharmaceuticals, Inc. and Paul McBarron, dated as of January 1, 2014 (previously filed as Exhibit 10.5 to the Registrant’s Annual Report on Form 10-K, originally filed with the SEC on March 24, 2014, and incorporated by reference). | |
10.7† | | | Form of Change in Control Agreement by and between Cyclacel Pharmaceuticals, Inc. and Dr. Judy Chiao, dated as of December 10, 2010 (previously filed as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, originally filed with the SEC on December 14, 2010, and incorporated herein by reference). | |
10.8 | | | Agreement between the Company and Scottish Enterprise dated March 27, 2006 (previously filed as Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q, for the quarterly period ended June 30, 2009, originally filed with the SEC on August 13, 2009, and incorporated herein by reference). | |
10.9 | | | Addendum to Agreement between the Company and Scottish Enterprise dated June 22, 2009 (previously filed as Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q, for the quarterly period ended June 30, 2009, originally filed with the SEC on August 13, 2009, and incorporated herein by reference). | |
10.10# | | | License Agreement by and between Sankyo Co., Ltd. and Cyclacel Limited, dated September 10, 2003, and letter amendments dated April 1, 2004 and April 28, 2004 (previously filed as Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q, for the quarterly period ended June 30, 2011, originally filed with the SEC on August 12, 2011, and incorporated herein by reference). | |
10.11# | | | Amendment No. 4 to License Agreement between Daiichi Sankyo Company, Limited and Cyclacel Limited, dated July 11, 2011(previously filed as Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q, for the quarterly period ended June 30, 2011, originally filed with the SEC on August 12, 2011, and incorporated herein by reference). | |
10.12 | | | Common Stock Purchase Agreement, dated November 14, 2013, by and between Cyclacel Pharmaceuticals, Inc. and Aspire Capital Fund, LLC (previously filed as Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q, originally filed with the SEC on November 14, 2013, and incorporated herein by reference). | |
10.13 | | | Form of Securities Purchase Agreement, by and between Cyclacel Pharmaceuticals, Inc. and certain investors (previously filed as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, originally filed with the SEC on March 4, 2015, and incorporated herein by reference). | |
21 | | | Subsidiaries of Cyclacel Pharmaceuticals, Inc. (previously filed as Exhibit 21 to the Registrant’s Annual Report on Form 10-K, originally filed with the SEC on March 26, 2014, and incorporated herein by reference). | |
23.1* | | | Consent of Independent Registered Public Accounting Firm. | |
EXHIBIT NUMBER |
| |
DESCRIPTION
|
|
31.1* | | | Certification of Spiro Rombotis, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
31.2* | | | Certification of Paul McBarron, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
32.1** | | | Certification of Spiro Rombotis, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code). | |
32.2** | | | Certification of Paul McBarron, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code). | |
101 | | | The following materials from Cyclacel Pharmaceuticals, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2015, formatted in XBRL (Extensible Business Reporting Language): (i) the Condensed Consolidated Statements of Income, (ii) the Condensed Consolidated Balance Sheets, (iii) the Condensed Consolidated Statements of Cash Flows, and (iv) Notes to Condensed Consolidated Financial Statements. | |
| | | | CYCLACEL PHARMACEUTICALS, INC. | | |||
| Date: March 29, 2016 | | | By: | | |
/s/ Paul McBarron
Paul McBarron
Chief Operating Officer, Chief Financial Officer & Executive Vice President, Finance (Principal Financial and Accounting Officer) |
|
|
Signature
|
| |
Title
|
| |
Date
|
|
|
/s/ Spiro Rombotis
Spiro Rombotis
|
| |
President & Chief Executive Officer
(Principal Executive Officer) and Director |
| |
March 29 , 2016
|
|
|
/s/ Paul McBarron
Paul McBarron
|
| |
Chief Operating Officer, Chief Financial Officer & Executive Vice President, Finance (Principal Financial and Accounting Officer) and Director
|
| |
March 29, 2016
|
|
|
/s/ Dr. David U’Prichard
Dr. David U’Prichard
|
| |
Chairman
|
| |
March 29, 2016
|
|
|
/s/ Dr. Christopher Henney
Dr. Christopher Henney
|
| |
Vice Chairman
|
| |
March 29, 2016
|
|
|
/s/ Dr. Nicholas Bacopoulos
Dr. Nicholas Bacopoulos
|
| |
Director
|
| |
March 29, 2016
|
|
|
/s/ Sir John Banham
Sir John Banham
|
| |
Director
|
| |
March 29, 2016
|
|
|
/s/ Samuel L. Barker
Samuel L. Barker
|
| |
Director
|
| |
March 29, 2016
|
|
|
/s/ Gregory Hradsky
Gregory Hradsky
|
| |
Director
|
| |
March 29, 2016
|
|
|
/s/ Lloyd Sems
Lloyd Sems
|
| |
Director
|
| |
March 29, 2016
|
|
| Date: March 29, 2016 | | |
/s/ Spiro Rombotis
Spiro Rombotis
President & Chief Executive Officer |
|
| Date: March 29, 2016 | | |
/s/ Paul McBarron
Paul McBarron
Chief Operating Officer, Chief Financial Officer and Executive Vice President, Finance |
|
Document and Entity Information - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2015 |
Mar. 25, 2016 |
Jun. 30, 2015 |
|
Document and Entity Information [Abstract] | |||
Entity Registrant Name | Cyclacel Pharmaceuticals, Inc. | ||
Entity Central Index Key | 0001130166 | ||
Trading Symbol | cycc | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Smaller Reporting Company | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Common Stock, Shares Outstanding | 35,582,492 | ||
Entity Public Float | $ 17,662,869 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2015 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2015 | ||
Document Fiscal Period Focus | FY |
CONSOLIDATED BALANCE SHEETS (Parentheticals) - USD ($) $ in Thousands |
Dec. 31, 2015 |
Dec. 31, 2014 |
---|---|---|
CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 335,273 | 335,273 |
Preferred stock, shares outstanding | 335,273 | 335,273 |
Preferred stock, liquidation preference value (in dollars) | $ 3,989,749 | $ 3,989,749 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 35,582,492 | 23,199,469 |
Common stock, shares outstanding | 35,582,492 | 23,199,469 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands |
12 Months Ended | |
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Dec. 31, 2015 |
Dec. 31, 2014 |
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CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||
Net loss from continuing operations | $ (14,342) | $ (19,406) |
Net income from discontinued operations, net of tax | 19 | |
Net loss | (14,342) | (19,387) |
Translation adjustment | 6,420 | 8,020 |
Unrealized foreign exchange loss on intercompany loans | (6,536) | (8,391) |
Comprehensive loss | $ (14,458) | $ (19,758) |
Organization of the Company |
12 Months Ended |
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Dec. 31, 2015 | |
Organization of the Company | |
Organization of the Company | 1. Organization of the Company
Cyclacel Pharmaceuticals, Inc. (“Cyclacel” or “the Company”), a biopharmaceutical company, is a pioneer in the field of cell cycle biology with a vision to improve patient healthcare with orally available innovative medicines. Cyclacel’s goal is to develop and commercialize small molecule drugs that target the various phases of cell cycle control for the treatment of cancer and other serious diseases, particularly those of high unmet medical need.
Cyclacel’s clinical development priorities are focused on sapacitabine, an orally available, cell cycle modulating nucleoside analog and the cyclin dependent kinase inhibitor program.
Sapacitabine is being evaluated in the SEAMLESS Phase 3 study, which completed enrollment in December 2014 and is being conducted under a Special Protocol Assessment (“SPA”) agreement with the US Food and Drug Administration (“FDA”) for the front-line treatment of acute myeloid leukemia (“AML”) in the elderly and in other indications including myelodysplastic syndromes (“MDS”). Sapacitabine is also being evaluated in an oral regimen in combination with seliciclib in a Phase 1 study of patients with Homologous Recombination (HR) repair-deficient breast, ovarian and pancreatic cancers, including BRCA positive tumors. Sapacitabine has been evaluated in over 1,000 patients with various cancers. The FDA and the European Medicines Agency (“EMA”) have designated sapacitabine as an orphan drug for the treatment of both AML and MDS.
In Cyclacel’s second development program the Company is evaluating cyclin dependent kinase, or CDK, inhibitors. CDKs are involved in cancer cell growth, survival, metastatic spread and DNA damage repair. Seliciclib, Cyclacel’s lead CDK inhibitor, is an oral, highly selective inhibitor of CDK enzymes that are central to the process of cell division and cell cycle control. Seliciclib has been evaluated in over 450 patients with various cancers, including non-small cell lung cancer, or NSCLC, and nasopharyngeal cancer, or NPC, and has shown signs of anticancer activity. Cyclacel has retained worldwide rights to commercialize seliciclib. Seliciclib has completed a Phase 2b randomized study in third-line NSCLC and is currently undergoing a study in solid tumors in combination with Cyclacel’s own drug candidate, sapacitabine. Seliciclib is also being evaluated in Investigator Sponsored Trials, or ISTs, to treat Cushing’s disease and rheumatoid arthritis, or RA.
Cyclacel’s second generation CDK inhibitor, CYC065, is a highly selective inhibitor of CDKs targeting CDK2/9 enzymes with potential utility in both hematological malignancies and solid tumors. CYC065 has increased anti-proliferative potency and improved pharmaceutical properties compared to seliciclib. CYC065 is in an on-going first-in-human, Phase 1 trial to assess its safety, tolerability, pharmacokinetics and pharmacodynamics in advanced cancer patients. CYC065 was selected from the Company’s drug discovery program in Dundee, Scotland and its development was supported in part by a $1.9 million grant from the Biomedical Catalyst of the United Kingdom government.
In addition to these development programs, in Cyclacel’s polo-like kinase (“PLK”) inhibitor program, the Company has discovered CYC140 and other potent and selective small molecule inhibitors of PLK1, a kinase that is active during cell division, which targets the mitotic phase of the cell cycle. PLK was discovered by Professor David Glover, the Company’s Chief Scientist. The Company has received a grant award of approximately $3.5 million from the Biomedical Catalyst of the United Kingdom government to complete IND-directed preclinical development of CYC140.
Cyclacel currently retains virtually all marketing rights worldwide to the compounds associated with the Company’s drug programs.
As of December 31, 2015, substantially all efforts of the Company to date have been devoted to performing research and development, conducting clinical trials, developing and acquiring intellectual property, raising capital and recruiting and training personnel.
Capital Resources
We believe that existing funds together with cash generated from operations, such as the R&D tax credit, and recent financing activities are sufficient to satisfy our planned working capital, capital expenditures and other financial commitments through 2017.This is beyond the availability of mature data for final analysis of the SEAMLESS Phase 3 trial, which is expected to occur in the first half of 2016, but will not be sufficient to complete development of other indications or existing product candidates or to commercialize any of the Company’s product candidates. On July 10, 2015, Cyclacel entered into a Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald & Co., as sales agent (“Cantor”) under which it may, from time to time, sell shares of common stock having an aggregate offering price of up to $8.35 million through Cantor. As of December 31, 2015 approximately $0.5 million net proceeds have been received through the sale of shares under the agreement.
Basis of Presentation
The accompanying consolidated financial statements as of December 31, 2014 and 2015, and for each of the two years in the period ended December 31, 2015, have been prepared in accordance with accounting principles generally accepted in the United States, or U.S. GAAP. The consolidated financial statements include the financial statements of Cyclacel Pharmaceuticals, Inc. and all of the Company’s wholly owned subsidiaries. All intercompany balances and transactions have been eliminated.
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Summary of Significant Accounting Policies |
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Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies
Use of Estimates
The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and related disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Critical estimates include inputs used to determine clinical trial accruals, research and development expenditures, stock-based compensation expense and the recognition of revenue. Cyclacel reviews its estimates on an ongoing basis. The estimates are based on historical experience and on various other assumptions that the Company believes to be reasonable under the circumstances. Actual results may differ from these estimates. Cyclacel believes the judgments and estimates required by the following accounting policies to be significant in the preparation of the Company’s consolidated financial statements.
Risks and Uncertainties
Drug candidates developed by the Company typically will require approvals or clearances from the FDA, EMA or other similar regulatory agencies in other countries prior to commercial sales. There can be no assurance that the Company’s drug candidates will receive any of the required approvals or clearances. If the Company was denied approval or clearance or such approval was delayed, or is unable to obtain the necessary financing to complete development and approval, there will be a material adverse impact on the Company’s financial condition and results of operations. The Company has relied upon government grants to fund its earlier stage programs and does not expect to be able to continue to be successful in obtaining government grants to fund the Company’s research and development expenditure.
Foreign Currency and Currency Translation
Transactions that are denominated in a foreign currency are remeasured into the functional currency at the current exchange rate on the date of the transaction. Any foreign currency-denominated monetary assets and liabilities are subsequently remeasured at current exchange rates, with gains or losses recognized as foreign exchange (losses) gains in the statement of operations.
The assets and liabilities of the Company’s international subsidiary are translated from its functional currency into United States dollars at exchange rates prevailing at the balance sheet date. Average rates of exchange during the period are used to translate the statement of operations, while historical rates of exchange are used to translate any equity transactions.
Translation adjustments arising on consolidation due to differences between average rates and balance sheet rates, as well as unrealized foreign exchange gains or losses arising from translation of intercompany loans that are of a long-term-investment nature, are recorded in other comprehensive loss.
Segments
After considering its business activities and geographic reach, the Company has concluded that it operates in just one operating segment being the discovery, development and commercialization of novel, mechanism-targeted drugs to treat cancer and other serious disorders, with development operations in two geographic areas, namely the United States and the United Kingdom.
Cash and Cash Equivalents
Cash equivalents are stated at cost, which is substantially the same as fair value. The Company considers all highly liquid investments with an original maturity of three months or less at the time of initial purchase to be cash equivalents and categorizes such investments as held to maturity. The objectives of the Company’s cash management policy are to safeguard and preserve funds, to maintain liquidity sufficient to meet Cyclacel’s cash flow requirements and to attain a market rate of return.
The Company’s cash balance at December 31, 2015 was $20.4 million and it maintains its cash accounts in several entities both within the United States and the United Kingdom. The total cash balances for amounts held in the United States are insured by the Federal Deposit Insurance Corporation up to $250,000 per account. The Company has cash balances exceeding the balance insured by the FDIC that totaled approximately $16.3 million at December 31, 2015. The total cash balances for amounts held in the United Kingdom are insured by the UK Government Financial Services Compensation Scheme (“FSCS”) up to £75,000 per account. The Company has cash balances exceeding the balance insured by the FSCS that totaled approximately $2.0 million at December 31, 2015.
Fair Value of Financial Instruments
Financial instruments consist of cash and cash equivalents, accounts payable, accrued liabilities, financial instruments associated with stock purchase agreements and other arrangements. The carrying amounts of cash and cash equivalents, accounts payable, and accrued liabilities approximate their respective fair values due to the nature of the accounts, notably their short maturities. The financial instruments associated with stock purchase agreements and certain other liabilities are measured at fair value using applicable inputs as described in Note 5 — Fair Value.
Property, Plant and Equipment
The components of property, plant and equipment are stated at cost and depreciated on a straight-line basis over the estimated useful lives of the related assets, which are generally three to five years. Amortization of leasehold improvements is performed using the straight-line method over the shorter of the remaining lease term or the estimated useful life of the related assets, currently between five and fifteen years. Upon sale or retirement of assets, the costs and related accumulated depreciation and amortization are removed from the balance sheet and the resulting gain or loss on sale is reflected as a component of operating income or loss. Expenditures for maintenance and repairs are charged to operating expenses as incurred.
The Company did not sell any fixed assets during the years ended December 31, 2014 or 2015.
Impairment of Long-lived Assets
The Company reviews property, plant and equipment for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. The Company assesses the recoverability of the potentially affected long-lived assets by determining whether the carrying value of such assets can be recovered through undiscounted future operating cash flows.
Impairment, if any, is measured as the amount by which the carrying amount of a long-lived asset (or asset group) exceeds its fair value.
Revenue Recognition
Collaboration, supply and licensing agreements
Consideration received is allocated to each of the separable elements in an arrangement using the relative selling price method. An element is separable if it has value to the customer on a stand-alone basis.
The selling price used for each separable element will be based on vendor-specific objective evidence (“VSOE”) if available, third party evidence if VSOE is not available, or estimated selling price if neither VSOE nor third party evidence is available. Revenue is recognized for each separate element when persuasive evidence of an arrangement exists; delivery has occurred or services have been rendered; the fee is fixed or determinable; and collectability is reasonably assured.
Royalty income is recognized when the licensee sells the underlying product.
In June 2015, the Company entered into a collaboration, licensing and supply agreement with ManRos Therapeutics SA (“ManRos”), for the exclusive development and commercialization of the Company’s oral seliciclib capsules by ManRos as a treatment for cystic fibrosis (“CF”). Among other terms of the agreement, ManRos licensed rights to the Company’s proprietary clinical data to enable clinical development of seliciclib for CF indications. The agreement provides for supply of seliciclib investigational product for initial and later stage clinical trials of seliciclib in CF and technical assistance related to the Company’s know-how to facilitate these trials. The Company received an up-front payment in July 2015 and reached a development milestone in September 2015. The Company will receive further milestone payments and tiered royalties, if seliciclib is commercialized for the treatment of CF. The upfront and milestone payments have been allocated to the separate elements within the arrangement and recognized over the period in which the elements are being delivered. In the year ended December 31, 2015, the Company recognized revenue of $250,000.
Grant revenue
Grant revenues from government agencies and private research foundations are recognized as the related qualified research and development costs are incurred, up to the limit of the prior approval funding amounts. Grant revenues are not refundable.
Clinical Trial Accounting
Data management and monitoring of the Company’s clinical trials are performed with the assistance of contract research organizations (“CROs”) or clinical research associates (“CRAs”) in accordance with the Company’s standard operating procedures. Typically, CROs and CRAs bill monthly for services performed, and others bill based upon milestones achieved. For outstanding amounts, the Company accrues unbilled clinical trial expenses based on estimates of the level of services performed each period. Costs of setting up clinical trial sites for participation in the trials are recognized upon execution of the clinical trial agreement and expensed immediately as research and development expenses. Clinical trial costs related to patient enrollment are accrued as patients are entered into and progress through the trial.
Research and Development Expenditures
Research and development expenses consist primarily of costs associated with the Company’s product candidates, upfront fees, milestones, compensation and other expenses for research and development personnel, supplies and development materials, costs for consultants and related contract research, facility costs and depreciation. Expenditures relating to research and development are expensed as incurred.
Patent Costs
Patent prosecution costs are charged to operations as incurred as recoverability of such expenditure is uncertain.
Leased Assets
The costs of operating leases are charged to operations on a straight-line basis over the lease term.
Income Taxes
The Company accounts for income taxes under the liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized.
The Company applies the accounting guidance codified in ASC 740 “Income taxes” (“ASC 740”) related to accounting for uncertainty in income taxes. ASC 740 specifies the accounting for uncertainty in income taxes recognized in a company’s financial statements by prescribing a minimum probability threshold a tax position is required to meet before being recognized in the financial statements.
Credit is taken in the accounting period for research and development tax credits, which will be claimed from H.M. Revenue & Customs (“HMRC”), the United Kingdom’s taxation and customs authority, in respect of qualifying research and development costs incurred in the same accounting period.
Net Loss Per Common Share
The Company calculates net loss per common share in accordance with ASC 260 “Earnings Per Share” (“ASC 260”). Basic and diluted net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period.
The following potentially dilutive shares of common stock have not been included in the computation of diluted net loss per share for all periods as the result would be anti-dilutive.
Fair Value Measurements
Inputs used to determine fair value of financial and non-financial assets and liabilities are categorized using a fair value hierarchy that prioritizes observable and unobservable inputs into three broad levels, from Level 1, for quoted prices (unadjusted) in active markets for identical assets or liabilities, to Level 3, for unobservable inputs (see Note 5 — Fair Value). Management reviews the categorization of fair value inputs on a periodic basis and may determine that it is necessary to transfer an input from one level of the fair value hierarchy to another based on changes in events or circumstances, such as a change in the observability of an input. Any such transfer will be recognized at the end of the reporting period.
Stock-based Compensation
The Company grants stock options, restricted stock units and restricted stock to officers, employees and directors under the 2015 Equity Incentive Plan (“2015 Plan”), which was approved on May 22, 2015 and which replaced the Amended and Restated Equity Incentive Plan (“2006 Plan”), which was approved on March 16, 2006, amended on May 21, 2007, amended again and restated on April 14, 2008 and later amended on May 23, 2012. Under both plans, the Company has granted various types of awards, which are described more fully in Note 6 — Stock-Based Compensation Arrangements. The Company accounts for these awards under ASC 718 “Compensation — Stock Compensation” (“ASC 718”).
ASC 718 requires measurement of compensation cost for all stock-based awards at fair value on date of grant and recognition of compensation over the requisite service period for awards expected to vest. The fair value of restricted stock and restricted stock units is determined based on the number of shares granted and the quoted price of the Company’s common stock on the date of grant. The determination of grant-date fair value for stock option awards is estimated using the Black-Scholes model, which includes variables such as the expected volatility of the Company’s share price, the anticipated exercise behavior of employees, interest rates, and dividend yields. These variables are projected based on historical data, experience, and other factors. Changes in any of these variables could result in material adjustments to the expense recognized for share-based payments. Such value is recognized as expense over the requisite service period, net of estimated forfeitures, using the straight-line attribution method. The estimation of stock awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from current estimates, such amounts are recorded as a cumulative adjustment in the period estimates are revised. The Company considers many factors when estimating expected forfeitures, including type of awards granted, employee class, and historical experience. Actual results and future estimates may differ substantially from current estimates.
Comprehensive Income (Loss)
In accordance with ASC 220 “Comprehensive Income” (“ASC 220”), all components of comprehensive income (loss), including net income (loss), are reported in the financial statements in the period in which they are recognized. Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net income (loss) and other comprehensive income (loss), including foreign currency translation adjustments, are reported, net of any related tax effect, to arrive at comprehensive income (loss). No taxes were recorded on items of other comprehensive income.
Recent Events
Deficiency and Compliance Notice from The NASDAQ Stock Market
On February 2, 2016, the Company received a letter from the Listing Qualifications Staff (the “Staff”) of The NASDAQ Stock Market LLC (“NASDAQ”) indicating that the Company had not regained compliance with the $1.00 minimum bid price requirement for continued listing on The NASDAQ Capital Market, as set forth in NASDAQ Listing Rule 5450(a)(1), by the end of the previously granted compliance period that expired on February 2, 2016. As a result, the Staff indicated that the Company would be subject to delisting unless it timely requests a hearing before a NASDAQ Listing Qualifications Panel (the “Panel”).
The Company has scheduled a hearing before the Panel on March 31, 2016, at which it will present its plan to regain compliance with the minimum bid price requirement, and request a further extension of time to do so. The Panel has the discretion to grant the Company up to an additional 180 calendar days from the date of the Staff’s notice, or until August 1, 2016, to regain compliance with the minimum bid price requirement. The hearing will automatically stay any delisting action pending the issuance of a final decision and the expiration of any further extension granted by the Panel. There can be no assurance that the Panel will grant the Company’s request for continued listing.
Accounting Standards Adopted in the Period
On January 1, 2015, the Company adopted guidance issued by the Financial Accounting Standards Board (“FASB”) which changed the criteria for reporting discontinued operations and enhanced disclosure in this area. Under the new guidance, only disposals representing a strategic shift in operations should be presented as discontinued operations. This guidance has been adopted prospectively to all disposals (or classifications as held for sale) of components of an entity occurring after January 1, 2015 and all businesses or nonprofit activities that, on acquisition, are classified as held for sale, that occur after January 1, 2015. The adoption of this guidance has not had a material impact on the Company’s consolidated financial statements.
Recent Accounting Pronouncements Not Yet Effective
In February 2016, the FASB issued guidance on accounting for leases. The guidance requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases along with additional qualitative and quantitative guidance. The guidance is effective for fiscal years beginning after December 15, 2018. The impact of the adoption of this guidance has not yet been evaluated.
In January 2016, the FASB issued guidance requiring all equity investments to be measured at fair value with changes in the fair value recognized through net income (other than those accounted for under equity method of accounting or those that result in consolidation of the investee) and amended certain fair value disclosures requirements. The guidance is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.
In November 2015, the FASB issued guidance on the classification of deferred taxes on the balance sheet. The guidance is effective for fiscal periods beginning after December 15, 2016, and interim periods within those annual periods. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.
In September 2015, the FASB issued guidance that requires an acquirer in a business combination to recognize adjustments to provisional amounts that are identified during the measurement period in the reporting period in which the adjustment amounts are determined. The guidance should be applied prospectively and is effective for fiscal years beginning after December 15, 2015, including interim periods within those fiscal years. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.
In July 2015, the FASB issued guidance to simplify the measurement of inventory. Effective for periods beginning after December 15, 2016, inventory measured using the first-in-first-out or average costs methods will be reported at the lower of cost or realizable value. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.
In April 2015, the FASB issued guidance on a customer’s accounting for fees in a cloud computing arrangement. The guidance is adopted on a retrospective basis. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2015, and interim periods within those fiscal years. Early adoption is permitted. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.
In February 2015, the FASB issued guidance on consolidation, which changes the analysis an entity must perform to determine whether it should consolidate certain legal entities. This guidance is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2015. Early adoption is permitted. The guidance can be adopted using either a full retrospective or a modified retrospective method of transition. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.
In November 2014, the FASB issued guidance on how current US GAAP should be interpreted in evaluating the economic characteristics and risks of a host contract in a hybrid financial instrument that is issued in the form of a share. The guidance clarifies that an entity should include all relevant terms and features, including the embedded derivative feature being evaluated for bifurcation, in evaluating the nature of the host contract. The guidance is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2015. Early adoption is permitted. The guidance can be adopted on prospectively or on a modified retrospective basis. The Company is currently evaluating the impact of the guidance on its consolidated financial statements.
In August 2014, the FASB issued guidance on management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and the provision of related footnote disclosures. This guidance is effective for the annual period ending after December 15, 2016 and for annual and interim periods thereafter. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.
In June 2014, the FASB issued guidance on accounting for share based payments when the terms of an award provide that a performance target could be achieved after the requisite service period. The guidance requires that a performance target that affects vesting and that could be achieved after the requisite service period should be treated as a performance condition. This guidance is effective for annual periods, and interim periods within those annual periods, after December 15, 2015. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.
In May 2014, the FASB issued new guidance on accounting for revenue from contracts with customers. This new guidance will replace existing revenue guidelines with a new model, in which revenue is recognized upon transfer of control over goods or services to a customer. In August 2015, the FASB deferred the effective date of the guidance, which will now be effective for the Company on January 1, 2018, for both interim and annual periods. Early adoption is permitted for both interim and annual periods commencing on January 1, 2017. The guidance can be adopted using either a full retrospective (with certain practical expedients) or a modified retrospective method of transition. Under the modified retrospective approach, financial statements will be prepared for the year of adoption using the new standard, but prior periods will not be adjusted. Instead, companies will recognize a cumulative catch-up adjustment to the opening balance of retained earnings at the effective date for contracts that still require performance by the company, and disclose all line items in the year of adoption as if they were prepared under current revenue requirements. At this time, the Company has not decided on which method it will use to adopt the new standard, nor has it determined the effects of the new guidelines on its results of operations and financial position. For the foreseeable future, the Company’s revenues will be limited to grants received from government agencies or nonprofit organizations and revenues from collaboration, supply and licensing agreements, and we are evaluating the effects of the new standard on these types of revenue streams.
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Significant Contracts |
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Significant Contracts Disclosure [Abstract] | |
Significant Contracts | 3. Significant Contracts
Distribution, Licensing and Research Agreements
The Company has entered into licensing agreements with academic and research organizations. Under the terms of these agreements, the Company has received licenses to technology and patent applications. The Company is required to pay royalties on future sales of products employing the technology or falling under claims of patent applications.
Pursuant to the Daiichi Sankyo license under which the Company licenses certain patent rights for sapacitabine, its lead drug candidate, the Company is under an obligation to use reasonable endeavors to develop a product and obtain regulatory approval to sell a product and has agreed to pay Daiichi Sankyo an up-front fee, reimbursement for Daiichi Sankyo’s enumerated expenses, milestone payments and royalties on a country-by-country basis. The up-front fee, Phase 3 entry milestone, and certain past reimbursements have been paid. A further $10.0 million in aggregate milestone payments could be payable subject to achievement of all the specific contractual milestones which are primarily related to regulatory approval in various territories, and the Company’s decision to continue with these projects. Royalties are payable in each country for the term of patent protection in the country or for ten years following the first commercial sale of licensed products in the country, whichever is later. Royalties are payable on net sales. Net sales are defined as the gross amount invoiced by the Company or its affiliates or licensees, less discounts, credits, taxes, shipping and bad debt losses. The agreement extends from its commencement date to the date on which no further amounts are owed under it. If the Company wishes to appoint a third party to develop or commercialize a sapacitabine-based product in Japan, within certain limitations, Daiichi Sankyo must be notified and given a right of first refusal, with the right of first refusal ending sixty days after notification, to develop and/or commercialize in Japan. In general, the license may be terminated by the Company for technical, scientific, efficacy, safety, or commercial reasons on six months’ notice, or twelve months’ notice, if after a launch of a sapacitabine-based product, or by either party for material default. There were no milestones earned in 2014 or 2015 and there are no milestone payments that are expected to be applicable to the Company in 2016.
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Cash and Cash Equivalents | 4. Cash and Cash Equivalents
The following is a summary of cash and cash equivalents at December 31, 2014 and 2015 (in $000s):
Investments with original maturity of less than three months at time of purchase are made up of money market funds and commercial paper.
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Fair Value | 5. Fair Value
Fair Value Measurements
As defined in ASC 820 “Fair Value Measurements and Disclosures” (“ASC 820”), fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, ASC 820 establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below:
• Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.
• Level 2: Inputs other than quoted prices within Level 1 that are observable for the asset or liability, either directly or indirectly.
• Level 3: Unobservable inputs that are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.
In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considering counterparty credit risk in its measurement of fair value.
The fair value of the Company’s financial assets and liabilities that are measured on a recurring basis were determined using the following inputs as of December 31, 2014 (in $000s):
The fair value of the Company’s financial assets and liabilities that are measured on a recurring basis were determined using the following inputs as of December 31, 2015 (in $000s):
Financial Instrument Associated with Stock Purchase Agreement
On November 14, 2013, the Company entered into a common stock purchase agreement with Aspire Capital Fund, LLC (“Aspire”) (the “Purchase Agreement”) under which Aspire purchased 511,509 shares of common stock for an aggregate purchase price of $2.0 million and committed to purchase up to an additional 3,042,038 shares from time to time as directed by the Company over the next two years at prices derived from the market prices on or near the date of each sale (see Note 10 — Stockholders’ Equity).
The Company has accounted for the right to sell additional shares under the Purchase Agreement based on the guidance of ASC 815 “Derivative Financial Instruments” (“ASC 815”), which requires the instrument to be measured at fair value with changes in fair value reported in earnings each reporting period until the agreement is exhausted or expired. The primary inputs used to determine fair value are the price of the Company’s common stock, the remaining term, and aggregate share purchases on the measurement date. The instrument had a fair value of $0.5 million at the date of the transaction and a fair value of $0.1 million as of December 31, 2014.
On July 8, 2015, the Company sold all remaining 314,424 shares of common stock that were subject to its agreement with Aspire and the Aspire Agreement has automatically terminated by its terms.
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Prepaid Expenses and Other Current Assets | 6. Prepaid Expenses and Other Current Assets
The following is a summary of prepaid expenses and other current assets at December 31, 2014 and 2015 (in $000s):
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Property, Plant and Equipment |
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Property, Plant and Equipment | 7. Property, Plant, and Equipment
Property, plant and equipment consisted of the following at December 31, 2014 and 2015 (in $000s):
The depreciation and amortization of property, plant and equipment amounted to $0.2 million for each of the years ended December 31, 2014 and 2015.
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Accrued and Other Current Liabilities |
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Accrued and Other Current Liabilities | 8. Accrued and Other Current Liabilities
Accrued and other current liabilities consisted of the following at December 31, 2014 and 2015 (in $000s):
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Commitments and Contingencies |
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Commitments and Contingencies | 9. Commitments and Contingencies
General
Please refer to Note 3 — Significant Contracts for further discussion of certain of the Company’s commitments and contingencies.
Leases
The following is a summary of the Company’s contractual obligations and commitments relating to its facilities leases as at December 31, 2015 (in $000s):
Rent expense, which includes lease payments related to the Company’s research and development facilities and corporate headquarters and other rent related expenses was $0.5 million for each of the years ended December 31, 2014 and 2015, respectively.
In October 2000, the Company entered into a twenty-five year lease for its research and development facility in Dundee, Scotland. In November 2013, the Company entered into a one year commitment to sublease part of the aforementioned research and development facility in Dundee, Scotland and recognized approximately $0.1 million for the year ended December 31, 2014. The commitment terminated in December 2014 and there was no sublease income in the year ended December 31, 2015. In May 2011, the Company extended its lease for office space at its headquarters in Berkeley Heights, New Jersey, through February 2017.
Preferred Dividends
The Company’s Board of Directors considers numerous factors in determining whether to declare the quarterly dividend pursuant to the certificate of designations governing the terms of the Company’s outstanding 6% Convertible Exchangeable (“Preferred Stock”), including the requisite financial analysis and determination of a surplus. Accrued and unpaid dividends in arrears on preferred stock were $0.6 million, or $1.90 per share, of preferred stock, as of December 31, 2014 and
2015.
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Stockholders' Equity | 10. Stockholders’ Equity
Preferred Stock
As of December 31, 2015, there were 335,273 shares of the Company’s Preferred Stock issued and outstanding at an issue price of $10.00 per share. Dividends on the Preferred Stock are cumulative from the date of original issuance at the annual rate of 6% of the liquidation preference of the Preferred Stock, payable quarterly on the first day of February, May, August and November, commencing February 1, 2005. Any dividends must be declared by the Company’s Board of Directors and must come from funds that are legally available for dividend payments. The Preferred Stock has a liquidation preference of $10.00 per share, plus accrued and unpaid dividends.
The Preferred Stock is convertible at the option of the holder at any time into the Company’s shares of common stock at a conversion rate of approximately 0.06079 shares of common stock for each share of Preferred Stock based on a price of $164.50. The Company has reserved 20,381 shares of common stock for issuance upon conversion of the remaining shares of Preferred Stock outstanding at December 31, 2015. The shares of previously-converted Preferred Stock have been retired, cancelled and restored to the status of authorized but unissued shares of preferred stock, subject to reissuance by the Board of Directors as shares of Preferred Stock of one or more series.
The Company may automatically convert the Preferred Stock into common stock if the closing price of the Company’s common stock has exceeded $246.75, which is 150% of the conversion price of the Preferred Stock, for at least 20 trading days during any 30-day trading period, ending within five trading days prior to notice of automatic conversion.
The Certificate of Designations governing the Preferred Stock provides that if the Company fails to pay dividends on its Preferred Stock for six quarterly periods, holders of Preferred Stock are entitled to nominate and elect two directors to the Company’s Board of Directors. This right accrued to the holders of Preferred Stock as of August 2, 2010 and two directors were nominated and elected at the annual meeting held on May 24, 2011.
The Preferred Stock has no maturity date and no voting rights prior to conversion into common stock, except under limited circumstances.
The Company may, at its option, redeem the Preferred Stock in whole or in part, out of funds legally available at the redemption price of $10.00 per share.
The Preferred Stock is exchangeable, in whole but not in part, at the option of the Company on any dividend payment date beginning on November 1, 2005 (the “Exchange Date”) for the Company’s 6% Convertible Subordinated Debentures (“Debentures”) at the rate of $10.00 principal amount of Debentures for each share of Preferred Stock. The Debentures, if issued, will mature 25 years after the Exchange Date and have terms substantially similar to those of the Preferred Stock. No such exchanges have taken place as of December 31, 2015.
For the year ended December 31, 2014, the company declared dividends of $0.15 per share quarterly on its Preferred Stock. These dividends were paid on February 1, May 1, August 1 and November 3, 2014, respectively.
On February 18, 2015, the Board of Directors of the Company declared a quarterly cash dividend in the amount of $0.15 per share on the Company’s Preferred Stock. The cash dividend was paid on May 1, 2015 to the holders of record of the Preferred Stock as of the close of business on April 17, 2015.
On May 22, 2015, the Board of Directors of the Company declared a quarterly cash dividend in the amount of $0.15 per share on the Company’s Preferred Stock. The cash dividend was paid on August 1, 2015 to the holders of record of the Preferred Stock as of the close of business on July 17, 2015.
On October 14, 2015, the Board of Directors declared a quarterly cash dividend in the amount of $0.15 per share on the Company’s Preferred Stock. The cash dividend was paid on November 2, 2015 to the holders of record of the Preferred Stock as of the close of business on October 23, 2015.
On December 24, 2015, the Board of Directors declared a quarterly cash dividend in the amount of $0.15 per share on the Company’s Preferred Stock. The cash dividend was paid on February 1, 2016 to the holders of record of the Preferred Stock as of the close of business on January 21, 2016.
Common Stock
July 2015 Controlled Equity OfferingSM
On July 10, 2015, the Company entered into a Controlled Equity OfferingSM Sales Agreement (the “Agreement”) with Cantor under which the Company may, from time to time, sell shares of its common stock having an aggregate offering price of up to $8.35 million through Cantor. Under the Agreement, Cantor may sell the Shares by methods deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities Act”). The Company will pay Cantor a commission of up to 3.0% of the gross sales price per share sold. Cyclacel is not obligated to make any sales under the Agreement. During the year ended December 31, 2015, the Company issued 879,583 shares of its common stock for proceeds, net of certain fees and expenses, of approximately $0.5 million.
March 2015 Public Offering
On March 9, 2015, the Company completed a public offering of 10,000,000 shares of its common stock at a price to the public of $1.00 per share for proceeds, net of certain fees and expenses, of approximately $9.2 million.
April 2014 Underwriting Agreement
On April 3, 2014, the Company entered into an underwriting agreement relating to the public offering and sale of 2,857,143 shares of the Company’s common stock, par value $0.001 per share, at a price to the public of $3.50 per share, for proceeds, net of certain fees and expenses, of approximately $9.3 million.
November 2013 Stock Purchase Agreement
On November 14, 2013, the Company entered into a common stock Purchase Agreement with Aspire (the “Purchase Agreement”). Upon execution of the Purchase Agreement, Aspire purchased 511,509 shares of common stock for an aggregate purchase price of $2.0 million. Under the terms of the Purchase Agreement, Aspire has committed to purchase up to an additional 3,042,038 shares from time to time as directed by the Company or, in certain instances, as agreed to by both parties, over the next two years at prices derived from the market prices on or near the date of each sale. However, such commitment is limited to an additional $18.0 million of share purchases. In consideration for entering into the Purchase Agreement, concurrent with the execution of the Purchase Agreement, the Company issued 166,105 shares of the Company’s common stock to Aspire in lieu of a commitment fee. The fair value of these shares has been recorded as a component of other assets and will continue to be remeasured each reporting period, until the agreement is exhausted or expired, with gains or losses reported in the consolidated statements of operations. During the year ended December 31, 2014, the Company sold 950,000 shares to Aspire under the Purchase Agreement for proceeds of $3.1 million.
During the year ended December 31, 2015, the Company sold all remaining 1,414,424 shares of common stock that were subject to the Purchase Agreement for net proceeds of approximately $1.4 million. All of the available shares under the Aspire Agreement have now been sold and the Aspire Agreement has automatically terminated by its terms.
Summary of Outstanding Warrants
The following table summarizes information about warrants outstanding at December 31, 2015:
There were no exercises of warrants during the years ended December 31, 2014 and 2015. Warrants for 202,499 shares of common stock, issued in connection with the January 2010 stock issuance and warrants for 594,513 shares of common stock, issued in connection with the October 2010 stock issuance, expired during the year ended December 31, 2015.
Exercise of Stock Options
No stock options were exercised during the years ended December 31, 2014 and 2015.
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Stock-Based Compensation Arrangements | 11. Stock-Based Compensation Arrangements
ASC 718 requires compensation expense associated with share-based awards to be recognized over the requisite service period, which for the Company is the period between the grant date and the date the award vests or becomes exercisable. Most of the awards granted by the Company (and still outstanding), vest ratably over three or four years, however, certain awards granted to members of the Company’s Board of Directors vest in their entirety on the one-year anniversary following the date of grant.
The Company recognizes all share-based awards under the straight-line attribution method. ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company evaluates its forfeiture assumptions quarterly and the expected forfeiture rate is adjusted when necessary. Ultimately, the actual expense recognized over the vesting period is based on only those shares that vest.
Stock based compensation has been reported within expense line items on the consolidated statement of operations for 2014 and 2015 as shown in the following table (in $000s):
2015 Plan
On May 22, 2015, the Company’s stockholders approved the 2015 Plan, under which Cyclacel may make equity incentive grants to its officers, employees, directors and consultants. The Company has reserved 3,500,000 shares of its common stock under the 2015 Plan. The 2015 Plan replaces the 2006 Plan, under which there were no remaining reserved shares available for issuance as of September 30, 2015. Stock option awards granted under the Company’s equity incentive plans have a maximum life of 10 years and generally vest over a one to four-year period from the date of grant.
During 2015, the Company granted approximately 1,470,000 options to employees and directors with a grant date fair value of approximately $0.8 million. During 2014, the Company granted approximately 63,000 options to employees and directors with a grant date fair value of approximately $0.2 million. The weighted average grant-date fair values of options granted during the years ended December 31, 2014 and 2015 were $2.48 and $0.51, respectively.
As of December 31, 2015, the total remaining unrecognized compensation cost related to the non-vested stock options amounted to approximately $1.0 million, which will be amortized over the weighted-average remaining requisite service period of 2.19 years.
During the years ended December 31, 2014 and 2015, the Company did not settle any equity instruments with cash.
There were no stock option exercises during the years ended 2014 and 2015. No income tax benefits were recorded for the years ended December 2014 and 2015 because ASC 718 prohibits recognition of tax benefits for exercised stock options until such benefits are realized. The Company was not able to benefit from the deduction for exercised stock options for the years ended December 31, 2014 and 2015 because the Company incurred tax losses in each of those years.
Outstanding Options
A summary of the share option activity and related information is as follows:
The fair value of the stock options granted is calculated using the Black-Scholes option-pricing model as prescribed by ASC 718 using the following assumptions:
The expected term assumption was estimated using past history of early exercise behavior and expectations about future behaviors. The Company relied exclusively on its historical volatility as an input to the option pricing model as management believes that this rate will be representative of future volatility over the expected term of the options.
Estimates of pre-vesting option forfeitures are based on the Company’s experience. Currently the Company uses a forfeiture rate of 0 – 30% depending on when and to whom the options are granted. The Company adjusts its estimate of forfeitures over the requisite service period based on the extent to which actual forfeitures differ, or are expected to differ, from such estimates. Changes in estimated forfeitures are recognized through a cumulative adjustment in the period of change and may impact the amount of compensation expense to be recognized in future periods.
The Company considers many factors when estimating expected forfeitures, including types of awards, employee class, and historical experience. During the years ended December 31, 2014 and 2015, the Company recognized an expense of approximately $0.5 million and $0.1 million, respectively, as a result of revised forfeiture rates.
The weighted average risk-free interest rate represents interest rate for treasury constant maturities published by the Federal Reserve Board. If the term of available treasury constant maturity instruments is not equal to the expected term of an employee option, Cyclacel uses the weighted average of the two Federal Reserve securities closest to the expected term of the employee option.
Restricted Stock Units
The Company issued 85,097 restricted stock units to employees during the year ended December 31, 2013, the vesting of which is dependent upon the fulfillment of certain clinical and financial conditions. The Company determined that the satisfaction of the clinical and financial conditions was probable at December 31, 2014 and, as a result, recorded an expense of $0.5 million related to 80,969 restricted stock units, net of forfeitures, for the year ended December 31, 2014. The restricted stock units were valued based on the fair value at the date of grant, which is equivalent to the market price of a share of the Company’s common stock. The expense was recognized entirely in the fourth quarter of 2014 as the awards became probable of vesting in that quarter. Summarized information for restricted stock unit activity for the years ended December 31, 2014 and 2015 is as follows:
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Employee Benefit Plans | 12. Employee Benefit Plans
Pension Plan
The Company operates a defined contribution group personal pension plan for all of its UK based employees. Company contributions to the plan totaled approximately $63,000 and $65,000 for the years ended December 31, 2014 and 2015, respectively.
401(k) Plan
The 401(k) Plan provides for matching contributions by the Company in an amount equal to the lesser of 100% of the employee’s deferral or 6% of the U.S. employee’s qualifying compensation. The 401(k) Plan is intended to qualify under Section 401(k) of the Internal Revenue Code, so that contributions to the 401(k) Plan by employees or by the Company, and the investment earnings thereon, are not taxable to the employees until withdrawn. Company matching contributions are tax deductible by the Company when made. Company employees may elect to reduce their current compensation by up to the statutorily prescribed annual limit of $18,000 if under 50 years old and $24,000 if over 50 years old and to have those funds contributed to the 401(k) Plan. The Company made contributions of approximately $46,000 and $47,000 to the 401(k) Plan for the years ended December 31, 2014 and 2015, respectively.
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Discontinued Operations | 13. Discontinued Operations
On August 10, 2012, the Company entered into an agreement with Sinclair Pharmaceuticals Limited (“Sinclair”) to terminate, effective September 30, 2012, the distribution agreements relating to the promotion and sale of Xclair®, Numoisyn® Lozenges and Numoisyn® Liquid (collectively, the “ALIGN products”).
Product revenue, cost of goods sold and selling, general and administrative costs related to the promotion and sale of the ALIGN products have been reclassified from operating results from continuing operations to income from discontinued operations in the consolidated statement of operations for all periods presented as follows (in $000s):
The assets and liabilities associated with product promotion and sales have been classified within assets and liabilities of discontinued operations in the accompanying consolidated balance sheets (in $000s):
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Taxes |
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Taxes | 14. Taxes
(Loss) income from continuing operations before taxes is comprised of the following components for the years ended December 31, 2014 and 2015 (in $000s):
The benefit (provision) for income taxes from continuing operations consists of the following (in $000s):
The Company has incurred a taxable loss in each of the operating periods since incorporation. The income tax credits of $3.2 million and $2.1 million for the years ended December 31, 2014 and 2015, respectively, represent UK research and development (“R&D”) tax credits for expenditures in the United Kingdom that are refundable.
A reconciliation of the (benefit) provision for income taxes from continuing operations with the amount computed by applying the statutory federal tax rate to loss from continuing operations before income taxes is as follows (in $000s):
Significant components of the Company’s deferred tax assets are shown below (in $000s):
Deferred income taxes reflect the net tax effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting and tax purposes.
A valuation allowance has been established, as realization of such assets is uncertain. The Company’s management evaluated the positive and negative evidence bearing upon the realizability of its deferred assets, and has determined that, at present, the Company may not be able to recognize the benefits of the deferred tax assets under the more likely than not criteria. Accordingly, a valuation allowance of approximately $47.3 million has been established at December 31, 2015. The valuation allowance has decreased by approximately $4.2 million in 2015.
In certain circumstances, as specified in the Tax Reform Act of 1986, due to ownership changes, the Company’s ability to utilize its net operating loss (“NOL”) carryforwards may be limited. The benefit of deductions from the exercise of stock options is included in the NOL carryforwards. The benefit from these deductions will be recorded as a credit to additional paid-in capital if and when realized through a reduction of cash taxes. As of December 31, 2014 and 2015, the Company had federal NOLs of $23.9 million and $26.7 million and foreign NOLs of $173.0 million and $171.7 million, respectively. The Company’s federal NOLs will start to expire in 2026, and the state NOLs totaling $17.0 million will start expiring in 2023. The Company’s foreign NOL’s do not expire under UK tax law.
Utilization of the NOLs may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986 due to ownership change limitations that have occurred previously or that could occur in the future. These ownership changes may limit the amount of NOL and R&D credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. The Company completed a Section 382 study as of June 30, 2014 noting there was no ownership change since the Company’s formation. Management has evaluated all significant tax positions at December 31, 2014 and 2015 and concluded that there are no material uncertain tax positions. The Company would recognize both interest and penalties related to unrecognized benefits in income tax expense. The Company has not recorded any interest and penalties on any unrecognized tax benefits since its inception.
Tax years 2012, 2013 and 2014 remain open to examination by major taxing jurisdictions to which the Company is subject, which are primarily in the United Kingdom and the United States, as carryforward attributes generated in years past may still be adjusted upon examination by the United Kingdom’s H.M. Revenue & Customs, the Internal Revenue Service (“IRS”) or state tax authorities. The Company is currently not under examination by the IRS or any other jurisdictions for any tax years.
We have not provided a deferred tax liability on the cumulative amount of unremitted foreign earnings of international subsidiaries because it is our intent to permanently reinvest such earnings outside of the United States. We would recognize this deferred tax liability if we were to experience a change in circumstances producing a change in that intention. The United States foreign tax credits which would arise upon such a distribution have also not been recognized.
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Geographic Information |
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Geographic Information | 15. Geographic Information
Geographic information for the years ended December 31, 2014 and 2015 is as follows (in $000s):
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Subsequent Events |
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Subsequent Events | |
Subsequent Events | 16. Subsequent Events
Deficiency and Compliance Notice from The NASDAQ Stock Market
On February 2, 2016, the Company received a letter from the Listing Qualifications Staff (the “Staff”) of The NASDAQ Stock Market LLC (“NASDAQ”) indicating that the Company had not regained compliance with the $1.00 minimum bid price requirement for continued listing on The NASDAQ Capital Market, as set forth in NASDAQ Listing Rule 5450(a)(1), by the end of the previously granted compliance period that expired on February 2, 2016. As a result, the Staff indicated that the Company would be subject to delisting unless it timely requests a hearing before a NASDAQ Listing Qualifications Panel (the “Panel”).
The Company has scheduled a hearing before the Panel on March 31, 2016, at which it will present its plan to regain compliance with the minimum bid price requirement, and request a further extension of time to do so. The Panel has the discretion to grant the Company up to an additional 180 calendar days from the date of the Staff’s notice, or until August 1, 2016, to regain compliance with the minimum bid price requirement. The hearing will automatically stay any delisting action pending the issuance of a final decision and the expiration of any further extension granted by the Panel. There can be no assurance that the Panel will grant the Company’s request for continued listing.
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Summary of Significant Accounting Policies (Policies) |
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Summary of Significant Accounting Policies | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Use of Estimates | Use of Estimates
The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and related disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Critical estimates include inputs used to determine clinical trial accruals, research and development expenditures, stock-based compensation expense and the recognition of revenue. Cyclacel reviews its estimates on an ongoing basis. The estimates are based on historical experience and on various other assumptions that the Company believes to be reasonable under the circumstances. Actual results may differ from these estimates. Cyclacel believes the judgments and estimates required by the following accounting policies to be significant in the preparation of the Company’s consolidated financial statements.
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Risks and Uncertainties | Risks and Uncertainties
Drug candidates developed by the Company typically will require approvals or clearances from the FDA, EMA or other similar regulatory agencies in other countries prior to commercial sales. There can be no assurance that the Company’s drug candidates will receive any of the required approvals or clearances. If the Company was denied approval or clearance or such approval was delayed, or is unable to obtain the necessary financing to complete development and approval, there will be a material adverse impact on the Company’s financial condition and results of operations. The Company has relied upon government grants to fund its earlier stage programs and does not expect to be able to continue to be successful in obtaining government grants to fund the Company’s research and development expenditure.
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Foreign Currency and Currency Translation | Foreign Currency and Currency Translation
Transactions that are denominated in a foreign currency are remeasured into the functional currency at the current exchange rate on the date of the transaction. Any foreign currency-denominated monetary assets and liabilities are subsequently remeasured at current exchange rates, with gains or losses recognized as foreign exchange (losses) gains in the statement of operations.
The assets and liabilities of the Company’s international subsidiary are translated from its functional currency into United States dollars at exchange rates prevailing at the balance sheet date. Average rates of exchange during the period are used to translate the statement of operations, while historical rates of exchange are used to translate any equity transactions.
Translation adjustments arising on consolidation due to differences between average rates and balance sheet rates, as well as unrealized foreign exchange gains or losses arising from translation of intercompany loans that are of a long-term-investment nature, are recorded in other comprehensive loss.
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Segments | Segments
After considering its business activities and geographic reach, the Company has concluded that it operates in just one operating segment being the discovery, development and commercialization of novel, mechanism-targeted drugs to treat cancer and other serious disorders, with development operations in two geographic areas, namely the United States and the United Kingdom.
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Cash and Cash Equivalents | Cash and Cash Equivalents
Cash equivalents are stated at cost, which is substantially the same as fair value. The Company considers all highly liquid investments with an original maturity of three months or less at the time of initial purchase to be cash equivalents and categorizes such investments as held to maturity. The objectives of the Company’s cash management policy are to safeguard and preserve funds, to maintain liquidity sufficient to meet Cyclacel’s cash flow requirements and to attain a market rate of return.
The Company’s cash balance at December 31, 2015 was $20.4 million and it maintains its cash accounts in several entities both within the United States and the United Kingdom. The total cash balances for amounts held in the United States are insured by the Federal Deposit Insurance Corporation up to $250,000 per account. The Company has cash balances exceeding the balance insured by the FDIC that totaled approximately $16.3 million at December 31, 2015. The total cash balances for amounts held in the United Kingdom are insured by the UK Government Financial Services Compensation Scheme (“FSCS”) up to £75,000 per account. The Company has cash balances exceeding the balance insured by the FSCS that totaled approximately $2.0 million at December 31, 2015.
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Fair Value of Financial Instruments | Fair Value of Financial Instruments
Financial instruments consist of cash and cash equivalents, accounts payable, accrued liabilities, financial instruments associated with stock purchase agreements and other arrangements. The carrying amounts of cash and cash equivalents, accounts payable, and accrued liabilities approximate their respective fair values due to the nature of the accounts, notably their short maturities. The financial instruments associated with stock purchase agreements and certain other liabilities are measured at fair value using applicable inputs as described in Note 5 — Fair Value.
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Property, Plant and Equipment | Property, Plant and Equipment
The components of property, plant and equipment are stated at cost and depreciated on a straight-line basis over the estimated useful lives of the related assets, which are generally three to five years. Amortization of leasehold improvements is performed using the straight-line method over the shorter of the remaining lease term or the estimated useful life of the related assets, currently between five and fifteen years. Upon sale or retirement of assets, the costs and related accumulated depreciation and amortization are removed from the balance sheet and the resulting gain or loss on sale is reflected as a component of operating income or loss. Expenditures for maintenance and repairs are charged to operating expenses as incurred.
The Company did not sell any fixed assets during the years ended December 31, 2014 or 2015.
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Impairment of Long-lived Assets | Impairment of Long-lived Assets
The Company reviews property, plant and equipment for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. The Company assesses the recoverability of the potentially affected long-lived assets by determining whether the carrying value of such assets can be recovered through undiscounted future operating cash flows.
Impairment, if any, is measured as the amount by which the carrying amount of a long-lived asset (or asset group) exceeds its fair value.
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Revenue Recognition | Revenue Recognition
Collaboration, supply and licensing agreements
Consideration received is allocated to each of the separable elements in an arrangement using the relative selling price method. An element is separable if it has value to the customer on a stand-alone basis.
The selling price used for each separable element will be based on vendor-specific objective evidence (“VSOE”) if available, third party evidence if VSOE is not available, or estimated selling price if neither VSOE nor third party evidence is available. Revenue is recognized for each separate element when persuasive evidence of an arrangement exists; delivery has occurred or services have been rendered; the fee is fixed or determinable; and collectability is reasonably assured.
Royalty income is recognized when the licensee sells the underlying product.
In June 2015, the Company entered into a collaboration, licensing and supply agreement with ManRos Therapeutics SA (“ManRos”), for the exclusive development and commercialization of the Company’s oral seliciclib capsules by ManRos as a treatment for cystic fibrosis (“CF”). Among other terms of the agreement, ManRos licensed rights to the Company’s proprietary clinical data to enable clinical development of seliciclib for CF indications. The agreement provides for supply of seliciclib investigational product for initial and later stage clinical trials of seliciclib in CF and technical assistance related to the Company’s know-how to facilitate these trials. The Company received an up-front payment in July 2015 and reached a development milestone in September 2015. The Company will receive further milestone payments and tiered royalties, if seliciclib is commercialized for the treatment of CF. The upfront and milestone payments have been allocated to the separate elements within the arrangement and recognized over the period in which the elements are being delivered. In the year ended December 31, 2015, the Company recognized revenue of $250,000.
Grant revenue
Grant revenues from government agencies and private research foundations are recognized as the related qualified research and development costs are incurred, up to the limit of the prior approval funding amounts. Grant revenues are not refundable.
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Clinical Trial Accounting | Clinical Trial Accounting
Data management and monitoring of the Company’s clinical trials are performed with the assistance of contract research organizations (“CROs”) or clinical research associates (“CRAs”) in accordance with the Company’s standard operating procedures. Typically, CROs and CRAs bill monthly for services performed, and others bill based upon milestones achieved. For outstanding amounts, the Company accrues unbilled clinical trial expenses based on estimates of the level of services performed each period. Costs of setting up clinical trial sites for participation in the trials are recognized upon execution of the clinical trial agreement and expensed immediately as research and development expenses. Clinical trial costs related to patient enrollment are accrued as patients are entered into and progress through the trial.
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Research and Development Expenditures | Research and Development Expenditures
Research and development expenses consist primarily of costs associated with the Company’s product candidates, upfront fees, milestones, compensation and other expenses for research and development personnel, supplies and development materials, costs for consultants and related contract research, facility costs and depreciation. Expenditures relating to research and development are expensed as incurred.
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Patent Costs | Patent Costs
Patent prosecution costs are charged to operations as incurred as recoverability of such expenditure is uncertain.
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Leased Assets | Leased Assets
The costs of operating leases are charged to operations on a straight-line basis over the lease term.
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Income Taxes | Income Taxes
The Company accounts for income taxes under the liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized.
The Company applies the accounting guidance codified in ASC 740 “Income taxes” (“ASC 740”) related to accounting for uncertainty in income taxes. ASC 740 specifies the accounting for uncertainty in income taxes recognized in a company’s financial statements by prescribing a minimum probability threshold a tax position is required to meet before being recognized in the financial statements.
Credit is taken in the accounting period for research and development tax credits, which will be claimed from H.M. Revenue & Customs (“HMRC”), the United Kingdom’s taxation and customs authority, in respect of qualifying research and development costs incurred in the same accounting period.
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Net Loss Per Common Share | Net Loss Per Common Share
The Company calculates net loss per common share in accordance with ASC 260 “Earnings Per Share” (“ASC 260”). Basic and diluted net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period.
The following potentially dilutive shares of common stock have not been included in the computation of diluted net loss per share for all periods as the result would be anti-dilutive.
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Fair Value Measurements | Fair Value Measurements
Inputs used to determine fair value of financial and non-financial assets and liabilities are categorized using a fair value hierarchy that prioritizes observable and unobservable inputs into three broad levels, from Level 1, for quoted prices (unadjusted) in active markets for identical assets or liabilities, to Level 3, for unobservable inputs (see Note 5 — Fair Value). Management reviews the categorization of fair value inputs on a periodic basis and may determine that it is necessary to transfer an input from one level of the fair value hierarchy to another based on changes in events or circumstances, such as a change in the observability of an input. Any such transfer will be recognized at the end of the reporting period.
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Stock-based Compensation | Stock-based Compensation
The Company grants stock options, restricted stock units and restricted stock to officers, employees and directors under the 2015 Equity Incentive Plan (“2015 Plan”), which was approved on May 22, 2015 and which replaced the Amended and Restated Equity Incentive Plan (“2006 Plan”), which was approved on March 16, 2006, amended on May 21, 2007, amended again and restated on April 14, 2008 and later amended on May 23, 2012. Under both plans, the Company has granted various types of awards, which are described more fully in Note 6 — Stock-Based Compensation Arrangements. The Company accounts for these awards under ASC 718 “Compensation — Stock Compensation” (“ASC 718”).
ASC 718 requires measurement of compensation cost for all stock-based awards at fair value on date of grant and recognition of compensation over the requisite service period for awards expected to vest. The fair value of restricted stock and restricted stock units is determined based on the number of shares granted and the quoted price of the Company’s common stock on the date of grant. The determination of grant-date fair value for stock option awards is estimated using the Black-Scholes model, which includes variables such as the expected volatility of the Company’s share price, the anticipated exercise behavior of employees, interest rates, and dividend yields. These variables are projected based on historical data, experience, and other factors. Changes in any of these variables could result in material adjustments to the expense recognized for share-based payments. Such value is recognized as expense over the requisite service period, net of estimated forfeitures, using the straight-line attribution method. The estimation of stock awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from current estimates, such amounts are recorded as a cumulative adjustment in the period estimates are revised. The Company considers many factors when estimating expected forfeitures, including type of awards granted, employee class, and historical experience. Actual results and future estimates may differ substantially from current estimates.
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Comprehensive Income (Loss) | Comprehensive Income (Loss)
In accordance with ASC 220 “Comprehensive Income” (“ASC 220”), all components of comprehensive income (loss), including net income (loss), are reported in the financial statements in the period in which they are recognized. Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net income (loss) and other comprehensive income (loss), including foreign currency translation adjustments, are reported, net of any related tax effect, to arrive at comprehensive income (loss). No taxes were recorded on items of other comprehensive income.
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Recent Events | Recent Events
Deficiency and Compliance Notice from The NASDAQ Stock Market
On February 2, 2016, the Company received a letter from the Listing Qualifications Staff (the “Staff”) of The NASDAQ Stock Market LLC (“NASDAQ”) indicating that the Company had not regained compliance with the $1.00 minimum bid price requirement for continued listing on The NASDAQ Capital Market, as set forth in NASDAQ Listing Rule 5450(a)(1), by the end of the previously granted compliance period that expired on February 2, 2016. As a result, the Staff indicated that the Company would be subject to delisting unless it timely requests a hearing before a NASDAQ Listing Qualifications Panel (the “Panel”).
The Company has scheduled a hearing before the Panel on March 31, 2016, at which it will present its plan to regain compliance with the minimum bid price requirement, and request a further extension of time to do so. The Panel has the discretion to grant the Company up to an additional 180 calendar days from the date of the Staff’s notice, or until August 1, 2016, to regain compliance with the minimum bid price requirement. The hearing will automatically stay any delisting action pending the issuance of a final decision and the expiration of any further extension granted by the Panel. There can be no assurance that the Panel will grant the Company’s request for continued listing.
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Accounting Standards Adopted in the Period | Accounting Standards Adopted in the Period
On January 1, 2015, the Company adopted guidance issued by the Financial Accounting Standards Board (“FASB”) which changed the criteria for reporting discontinued operations and enhanced disclosure in this area. Under the new guidance, only disposals representing a strategic shift in operations should be presented as discontinued operations. This guidance has been adopted prospectively to all disposals (or classifications as held for sale) of components of an entity occurring after January 1, 2015 and all businesses or nonprofit activities that, on acquisition, are classified as held for sale, that occur after January 1, 2015. The adoption of this guidance has not had a material impact on the Company’s consolidated financial statements.
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Recent Accounting Pronouncements Not Yet Effective | Recent Accounting Pronouncements Not Yet Effective
In February 2016, the FASB issued guidance on accounting for leases. The guidance requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases along with additional qualitative and quantitative guidance. The guidance is effective for fiscal years beginning after December 15, 2018. The impact of the adoption of this guidance has not yet been evaluated.
In January 2016, the FASB issued guidance requiring all equity investments to be measured at fair value with changes in the fair value recognized through net income (other than those accounted for under equity method of accounting or those that result in consolidation of the investee) and amended certain fair value disclosures requirements. The guidance is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.
In November 2015, the FASB issued guidance on the classification of deferred taxes on the balance sheet. The guidance is effective for fiscal periods beginning after December 15, 2016, and interim periods within those annual periods. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.
In September 2015, the FASB issued guidance that requires an acquirer in a business combination to recognize adjustments to provisional amounts that are identified during the measurement period in the reporting period in which the adjustment amounts are determined. The guidance should be applied prospectively and is effective for fiscal years beginning after December 15, 2015, including interim periods within those fiscal years. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.
In July 2015, the FASB issued guidance to simplify the measurement of inventory. Effective for periods beginning after December 15, 2016, inventory measured using the first-in-first-out or average costs methods will be reported at the lower of cost or realizable value. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.
In April 2015, the FASB issued guidance on a customer’s accounting for fees in a cloud computing arrangement. The guidance is adopted on a retrospective basis. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2015, and interim periods within those fiscal years. Early adoption is permitted. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.
In February 2015, the FASB issued guidance on consolidation, which changes the analysis an entity must perform to determine whether it should consolidate certain legal entities. This guidance is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2015. Early adoption is permitted. The guidance can be adopted using either a full retrospective or a modified retrospective method of transition. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.
In November 2014, the FASB issued guidance on how current US GAAP should be interpreted in evaluating the economic characteristics and risks of a host contract in a hybrid financial instrument that is issued in the form of a share. The guidance clarifies that an entity should include all relevant terms and features, including the embedded derivative feature being evaluated for bifurcation, in evaluating the nature of the host contract. The guidance is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2015. Early adoption is permitted. The guidance can be adopted on prospectively or on a modified retrospective basis. The Company is currently evaluating the impact of the guidance on its consolidated financial statements.
In August 2014, the FASB issued guidance on management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and the provision of related footnote disclosures. This guidance is effective for the annual period ending after December 15, 2016 and for annual and interim periods thereafter. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.
In June 2014, the FASB issued guidance on accounting for share based payments when the terms of an award provide that a performance target could be achieved after the requisite service period. The guidance requires that a performance target that affects vesting and that could be achieved after the requisite service period should be treated as a performance condition. This guidance is effective for annual periods, and interim periods within those annual periods, after December 15, 2015. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.
In May 2014, the FASB issued new guidance on accounting for revenue from contracts with customers. This new guidance will replace existing revenue guidelines with a new model, in which revenue is recognized upon transfer of control over goods or services to a customer. In August 2015, the FASB deferred the effective date of the guidance, which will now be effective for the Company on January 1, 2018, for both interim and annual periods. Early adoption is permitted for both interim and annual periods commencing on January 1, 2017. The guidance can be adopted using either a full retrospective (with certain practical expedients) or a modified retrospective method of transition. Under the modified retrospective approach, financial statements will be prepared for the year of adoption using the new standard, but prior periods will not be adjusted. Instead, companies will recognize a cumulative catch-up adjustment to the opening balance of retained earnings at the effective date for contracts that still require performance by the company, and disclose all line items in the year of adoption as if they were prepared under current revenue requirements. At this time, the Company has not decided on which method it will use to adopt the new standard, nor has it determined the effects of the new guidelines on its results of operations and financial position. For the foreseeable future, the Company’s revenues will be limited to grants received from government agencies or nonprofit organizations and revenues from collaboration, supply and licensing agreements, and we are evaluating the effects of the new standard on these types of revenue streams.
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Summary of Significant Accounting Policies (Tables) |
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Summary of Significant Accounting Policies | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of antidilutive shares excluded from computation of diluted net loss per share |
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Cash and Cash Equivalents (Tables) |
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Schedule of summary of cash and cash equivalents |
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Fair Value (Tables) |
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Fair Value | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of financial assets and liabilities measured on a recurring basis | The fair value of the Company’s financial assets and liabilities that are measured on a recurring basis were determined using the following inputs as of December 31, 2014 (in $000s):
The fair value of the Company’s financial assets and liabilities that are measured on a recurring basis were determined using the following inputs as of December 31, 2015 (in $000s):
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Prepaid Expenses and Other Current Assets (Tables) |
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Schedule of prepaid expenses and other current assets |
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Property, Plant and Equipment (Tables) |
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Schedule of property, plant and equipment |
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Accrued and Other Current Liabilities (Tables) |
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Schedule of accrued and other current liabilities |
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Commitments and Contingencies (Tables) |
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Schedule of the Company's contractual obligations and commitments relating to its facilities leases |
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Stockholders' Equity (Tables) |
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Schedule of warrants outstanding |
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Stock-Based Compensation Arrangements (Tables) |
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Schedule of stock based compensation expense |
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Schedule of stock option activity |
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Schedule of assumptions for stock option grants to employees and directors |
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Schedule of restricted stock units activity |
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Discontinued Operations (Tables) |
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Schedule of assets and liabilities, and product revenue, cost of goods sold and selling, general and administrative costs of discontinued operations |
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Taxes (Tables) |
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Taxes | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of components of (loss) gain before taxes from continuing operations |
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Schedule of benefit for income taxes from continuing operations |
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Schedule of reconciliation of the (benefit) provision for income taxes from continuing operations with the amount computed by applying the statutory federal tax rate to loss before income taxes |
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Schedule of significant components of the entity's deferred tax assets |
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Geographic Information (Tables) |
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Geographic Information | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of geographic information |
|
Organization of the Company (Details Textuals) $ in Thousands |
12 Months Ended |
---|---|
Dec. 31, 2015
USD ($)
| |
Controlled Equity Offering Sales Agreement | Cantor Fitzgerald & Co., ("Cantor") | |
Organization [Line Items] | |
Maximum amount of offering price for common stock | $ 8,350 |
Proceeds received through sale of shares | 500 |
United kingdoms medical research council | Investigational new drug (IND) | |
Organization [Line Items] | |
Grant award amount | 1,900 |
Biomedical catalyst of United Kingdom government | Investigational new drug (IND) | |
Organization [Line Items] | |
Grant award amount | $ 3,500 |
Summary of Significant Accounting Policies (Details) - shares |
12 Months Ended | |
---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Net loss per common share | ||
Total shares excluded from calculation | 3,040,077 | 2,460,824 |
Stock options | ||
Net loss per common share | ||
Total shares excluded from calculation | 2,475,579 | 1,010,298 |
Restricted Stock Units | ||
Net loss per common share | ||
Total shares excluded from calculation | 89,016 | |
Convertible preferred stock | ||
Net loss per common share | ||
Total shares excluded from calculation | 20,381 | 20,381 |
Common stock warrants | ||
Net loss per common share | ||
Total shares excluded from calculation | 544,117 | 1,341,129 |
Significant Contracts (Detail textuals) - Daiichi Sankyo $ in Millions |
12 Months Ended |
---|---|
Dec. 31, 2015
USD ($)
| |
Loss Contingencies [Line Items] | |
Future milestone payments payable | $ 10 |
Period for which royalties will be paid following first commercial sale of licensed products | 10 years |
Notice period for termination of license by the entity for technical, scientific, efficacy, safety, or commercial reasons | 6 months |
Notice period for termination of license after launch of a sapacitabine-based product by the entity, or by either party for material default | 12 months |
Cash and Cash Equivalents (Details) - USD ($) $ in Thousands |
Dec. 31, 2015 |
Dec. 31, 2014 |
Dec. 31, 2013 |
---|---|---|---|
Cash and Cash Equivalents | |||
Cash | $ 8,487 | $ 5,870 | |
Investments with original maturity of less than three months at the time of purchase | 11,953 | 18,319 | |
Total cash and cash equivalents | $ 20,440 | $ 24,189 | $ 31,146 |
Fair Value (Details) - Recurring basis - USD ($) $ in Thousands |
Dec. 31, 2015 |
Dec. 31, 2014 |
---|---|---|
Level 1 | ||
ASSETS | ||
Cash equivalents | $ 11,953 | $ 18,319 |
Financial instrument associated with stock purchase agreement | ||
Total assets | $ 11,953 | $ 18,319 |
Level 2 | ||
ASSETS | ||
Cash equivalents | ||
Financial instrument associated with stock purchase agreement | $ 51 | |
Total assets | $ 51 | |
Level 3 | ||
ASSETS | ||
Cash equivalents | ||
Financial instrument associated with stock purchase agreement | ||
Total assets | ||
Total | ||
ASSETS | ||
Cash equivalents | $ 11,953 | $ 18,319 |
Financial instrument associated with stock purchase agreement | 51 | |
Total assets | $ 11,953 | $ 18,370 |
Fair Value (Detail Textuals) - USD ($) $ in Thousands |
12 Months Ended | |||
---|---|---|---|---|
Jul. 08, 2015 |
Nov. 14, 2013 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Fair value measurements | ||||
Purchase price for shares issued under purchase agreement | $ 1,406 | $ 3,132 | ||
Purchase Agreement | Aspire Capital Fund, LLC | ||||
Fair value measurements | ||||
Number of shares issued under purchase agreement | 511,509 | |||
Purchase price for shares issued under purchase agreement | $ 2,000 | |||
Shares committed to purchase | 3,042,038 | |||
Period of common stock purchase agreement | 2 years | |||
Fair value of financial instrument | $ 500 | $ 100 | ||
Common stock sold | 314,424 |
Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands |
Dec. 31, 2015 |
Dec. 31, 2014 |
---|---|---|
Prepaid Expense and Other Assets, Current [Abstract] | ||
Research and development tax credit receivable | $ 2,093 | $ 3,017 |
Prepayments | 893 | 902 |
Grant receivable | 326 | 134 |
VAT receivable | 607 | 309 |
Deposits | $ 132 | 132 |
Other current assets | 146 | |
Prepaid expenses and other current assets | $ 4,051 | $ 4,640 |
Property, Plant and Equipment (Detail Textuals) - USD ($) $ in Millions |
12 Months Ended | |
---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Property, Plant and Equipment | ||
Depreciation and amortization expense | $ 0.2 | $ 0.2 |
Accrued and Other Current Liabilities (Details) - USD ($) $ in Thousands |
Dec. 31, 2015 |
Dec. 31, 2014 |
---|---|---|
Accrued and Other Current Liabilities | ||
Accrued research and development | $ 3,284 | $ 4,161 |
Accrued legal and professional fees | 291 | 303 |
Other current liabilities | 163 | 162 |
Total | $ 3,738 | $ 4,626 |
Commitments and Contingencies (Details) $ in Thousands |
Dec. 31, 2015
USD ($)
|
---|---|
Operating Lease Obligations | |
2016 | $ 537 |
2017 | 408 |
2018 | 381 |
2019 | 373 |
2020 | 373 |
Thereafter | 1,795 |
Total | $ 3,867 |
Commitments and Contingencies (Detail Textuals) - USD ($) $ in Millions |
1 Months Ended | 12 Months Ended | ||
---|---|---|---|---|
Nov. 30, 2013 |
Oct. 31, 2000 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Leases, related disclosures | ||||
Rent expense, net | $ 0.5 | $ 0.5 | ||
Lease term for research and development facility | 25 years | |||
Term of sublease | 1 year | |||
Sublease income recognized | $ 0.1 |
Commitments and Contingencies (Detail Textuals 1) - USD ($) $ / shares in Units, $ in Millions |
12 Months Ended | |
---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Preferred Dividends | ||
Dividend rate (as a percent) | 6.00% | |
Accrued and unpaid dividends in arrears on preferred stock | $ 0.6 | $ 0.6 |
Accrued and unpaid dividends in arrears on preferred stock per share (in dollars per share) | $ 1.90 | $ 1.90 |
Stockholders' Equity (Details 1) |
12 Months Ended |
---|---|
Dec. 31, 2015
$ / shares
shares
| |
Warrants outstanding | |
Common Shares Issuable | shares | 544,117 |
Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 9.52 |
July 2011 stock issuance | |
Warrants outstanding | |
Expiration Date | 2016 |
Common Shares Issuable | shares | 544,117 |
Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 9.52 |
Stockholders' Equity (Detail Textuals 1) - Controlled Equity Offering Sales Agreement - Cantor Fitzgerald & Co., ("Cantor") $ in Thousands |
12 Months Ended |
---|---|
Dec. 31, 2015
USD ($)
shares
| |
Class of Stock [Line Items] | |
Proceeds received through sale of shares | $ 500 |
Percentage of gross sales price per share sold | 3.00% |
Stock Issued During Period, Shares, New Issues | shares | 879,583 |
Maximum amount of offering price for common stock | $ 8,350 |
Stockholders' Equity (Detail Textuals 2) - USD ($) $ / shares in Units, $ in Thousands |
12 Months Ended | |||
---|---|---|---|---|
Mar. 09, 2015 |
Apr. 03, 2014 |
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Equity Offering [Line Items] | ||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||
Proceed from public offering | $ 9,171 | $ 9,289 | ||
Common stock | ||||
Equity Offering [Line Items] | ||||
Number of common shares sold into underwriting agreement (in shares) | 10,000,000 | 2,857,143 | ||
Proceed from public offering | $ 10 | $ 3 | ||
Common stock | April 2014 Underwriting Agreement | ||||
Equity Offering [Line Items] | ||||
Number of common shares sold into underwriting agreement (in shares) | 2,857,143 | |||
Common stock, par value (in dollars per share) | $ 0.001 | |||
Share price per share | $ 1.00 | $ 3.50 | ||
Proceed from public offering | $ 9,300 | |||
Common stock | March 2015 Public Offering | ||||
Equity Offering [Line Items] | ||||
Number of common shares sold into underwriting agreement (in shares) | 10,000,000 | |||
Proceed from public offering | $ 9,200 |
Stock-Based Compensation Arrangements (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Stock-based compensation | ||
Stock-based compensation costs before income taxes | $ 745 | $ 1,223 |
Research and development | ||
Stock-based compensation | ||
Stock-based compensation costs before income taxes | 240 | 392 |
General and administrative | ||
Stock-based compensation | ||
Stock-based compensation costs before income taxes | $ 505 | $ 831 |
Stock-Based Compensation Arrangements (Details 2) - Stock options - $ / shares |
12 Months Ended | |
---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Fair value of the stock options granted calculated using Black-Scholes option-pricing model assumptions | ||
Expected term | 6 years | |
Volatility (as a percent) | 101.00% | |
Expected dividend yield over expected term (as a percent) | 0.00% | 0.00% |
Resulting weighted average grant fair value (in dollars per share) | $ 0.51 | $ 2.48 |
Minimum | ||
Fair value of the stock options granted calculated using Black-Scholes option-pricing model assumptions | ||
Expected term | 5 years | |
Risk free interest rate (as a percent) | 1.52% | 1.835% |
Volatility (as a percent) | 96.00% | |
Maximum | ||
Fair value of the stock options granted calculated using Black-Scholes option-pricing model assumptions | ||
Expected term | 6 years | |
Risk free interest rate (as a percent) | 1.845% | 2.005% |
Volatility (as a percent) | 108.00% |
Stock-Based Compensation Arrangements (Details 3) - Restricted Stock Units - $ / shares |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
Dec. 31, 2013 |
|
Nonvested activity | |||
Non-vested at the beginning of the period (in shares) | 89,016 | 119,248 | |
Granted (in shares) | 85,097 | ||
Vested (in shares) | (89,016) | (29,999) | |
Forfeited (in shares) | (233) | ||
Non-vested at the end of the period (in shares) | 89,016 | 119,248 | |
Weighted Average Grant Date Value Per Share | |||
Non-vested at the beginning of the period (in dollars per share) | $ 5.56 | $ 5.62 | |
Granted (in dollars per share) | |||
Forfeited (in dollars per share) | $ 5.81 | ||
Vested (in dollars per share) | $ 5.56 | 5.39 | |
Non-vested at the end of the period (in dollars per share) | $ 5.56 | $ 5.62 |
Stock-Based Compensation Arrangements (Detail Textuals 2) - USD ($) $ in Millions |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
Dec. 31, 2013 |
|
Stock options | |||
Stock based compensation, additional disclosures | |||
Income (expense) recognized due to revision of forfeiture rate | $ 0.1 | $ 0.5 | |
Stock options | Minimum | |||
Stock based compensation, additional disclosures | |||
Forfeiture rate (as a percent) | 0.00% | ||
Stock options | Maximum | |||
Stock based compensation, additional disclosures | |||
Forfeiture rate (as a percent) | 30.00% | ||
Restricted Stock Units | |||
Stock based compensation, additional disclosures | |||
Income (expense) recognized due to revision of forfeiture rate | $ 0.5 | ||
Granted (in shares) | 85,097 | ||
Restricted stock units, net of forfeitures | 80,969 |
Employee Benefit Plans (Detail Textuals) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Pension Plan | ||
Employee benefit plans | ||
Contribution made by the entity under the pension plan | $ 65,000 | $ 63,000 |
401 (k) Plan | ||
Employee benefit plans | ||
Matching contribution by employer as a percentage of the employee's deferral | 100.00% | |
Matching contribution by employer as a percentage of U.S. employee's qualifying compensation | 6.00% | |
Statutorily prescribed annual limit of contributions made by an employee before attaining age of 50 years | $ 18,000 | |
Statutorily prescribed annual limit of contributions made by an employee after attaining age of 50 years | $ 24,000 | |
Specified age limit of employees for calculation of statutorily prescribed annual limit of contribution | 50 years | |
Contribution made by the entity under the 401(k) Plan | $ 47,000 | $ 46,000 |
Discontinued Operations (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Reclassification of operating results from continuing operations to loss from discontinued operations | ||
Income tax on discontinued operations | $ (10) | |
Net income from discontinued operations, net of tax | 19 | |
ALIGN products | ||
Reclassification of operating results from continuing operations to loss from discontinued operations | ||
Interest income | 29 | |
Income tax on discontinued operations | (10) | |
Net income from discontinued operations, net of tax | $ 19 |
Discontinued Operations (Details 1) - USD ($) $ in Thousands |
Dec. 31, 2015 |
Dec. 31, 2014 |
---|---|---|
Current assets of discontinued operations: | ||
Total current assets of discontinued operations | $ 75 | $ 171 |
Current liabilities of discontinued operations: | ||
Total current liabilities of discontinued operations | 75 | 75 |
ALIGN products | ||
Current assets of discontinued operations: | ||
Short-term portion of minimum royalty arrangement receivable, net | 96 | |
Returns indemnification receivable | 75 | 75 |
Total current assets of discontinued operations | $ 75 | $ 171 |
Long-term assets of discontinued operations: | ||
Long-term portion of minimum royalty arrangement receivable, net | ||
Total assets of discontinued operations | $ 75 | $ 171 |
Current liabilities of discontinued operations: | ||
Returns provision | 75 | 75 |
Total current liabilities of discontinued operations | $ 75 | $ 75 |
Taxes (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Loss (income) from continuing operations before taxes | ||
Domestic | $ (2,520) | $ (2,898) |
Foreign | (13,966) | (19,751) |
Loss from continuing operations before taxes | $ (16,486) | $ (22,649) |
Taxes (Details 1) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Benefit for income taxes from continuing operations | ||
Current - domestic | $ 34 | |
Current - foreign | $ 2,144 | 3,209 |
Current - total | $ 2,144 | $ 3,243 |
Deferred - domestic | ||
Income tax benefit | $ 2,144 | $ 3,243 |
Taxes (Details 2) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Reconciliation of the (benefit) provision for income taxes | ||
Loss from continuing operations before taxes | $ (16,486) | $ (22,649) |
Income tax expense computed at statutory federal tax rate | (5,605) | (7,701) |
Disallowed expenses and non-taxable income | 27 | 406 |
Loss surrendered to generate R&D credit | 2,479 | 7,294 |
Additional research and development tax relief | (3,402) | (7,262) |
Change in valuation allowance | $ (4,189) | $ (4,963) |
Research and development credit - prior years | ||
Foreign items, including change in tax rates, and other | $ 6,882 | $ 3,555 |
Other foreign items | 1,664 | 5,428 |
Current - total | $ (2,144) | $ (3,243) |
Taxes (Details 3) - USD ($) $ in Thousands |
Dec. 31, 2015 |
Dec. 31, 2014 |
---|---|---|
Significant components of the entity's deferred tax assets | ||
Net operating loss carryforwards | $ 41,003 | $ 45,060 |
Depreciation, amortization and impairment of property and equipment | 101 | 81 |
Stock options | $ 2,193 | 1,815 |
Accrued expenses | 179 | |
Research and development credits | $ 4,021 | 4,332 |
Other | $ 38 | $ 78 |
Translation adjustment | ||
Deferred tax assets | $ 47,356 | $ 51,545 |
Valuation allowance for deferred tax assets | $ (47,356) | $ (51,545) |
Net deferred taxes |
Taxes (Detail Textuals) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Taxes | ||
Valuation allowance for deferred tax assets | $ 47,356 | $ 51,545 |
Change in valuation allowance | (4,189) | (4,963) |
Federal | ||
Taxes | ||
NOLs carryforward | 26,700 | 23,900 |
Foreign | ||
Taxes | ||
NOLs carryforward | 171,700 | 173,000 |
State | ||
Taxes | ||
NOLs carryforward | 17,000 | |
Research and development | Foreign | ||
Taxes | ||
Income tax credits | $ 2,100 | $ 3,200 |
Geographic Information (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2015 |
Dec. 31, 2014 |
|
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenue | $ 1,944 | $ 1,734 |
Net loss | (14,342) | (19,387) |
Assets | 24,764 | 29,387 |
Long Lived Assets, net | 198 | 387 |
United Kingdom | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenue | 1,944 | 1,734 |
Net loss | (11,822) | (16,541) |
Assets | 7,565 | 10,293 |
Long Lived Assets, net | 194 | 381 |
United States | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Net loss | (2,520) | (2,846) |
Assets | 17,199 | 19,094 |
Long Lived Assets, net | 6 | |
United States | Continuing operations | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Net loss | (2,520) | (2,865) |
Assets | 17,124 | 18,923 |
Long Lived Assets, net | $ 4 | 6 |
United States | Discontinued operations | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Net loss | 19 | |
Assets | $ 75 | $ 171 |
Long Lived Assets, net |
Subsequent Events (Detail Textuals) - Subsequent event |
Feb. 02, 2016
$ / shares
|
---|---|
Subsequent Event [Line Items] | |
Minimum bid price | $ 1.00 |
Compliance condition | The Panel has the discretion to grant the Company up to an additional 180 calendar days from the date of the Staff's notice, or until August 1, 2016, to regain compliance with the minimum bid price requirement. |
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