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SECURITIES AND EXCHANGE COMMISSION
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware (State or Other Jurisdiction of Incorporation or Organization) | 91-1707622 (I.R.S. Employer Identification No.) |
200 Connell Drive, Suite 1500 Berkeley Heights, New Jersey (Address of principal executive offices) | 07922 (Zip Code) |
Yeso Noo
Large accelerated filer o | Accelerated filer o | Non-accelerated filer o (Do not check if a smaller reporting company) | Smaller reporting company þ |
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38 | ||||||||
67 | ||||||||
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Exhibit 31.1 | ||||||||
Exhibit 31.2 | ||||||||
Exhibit 32.1 | ||||||||
Exhibit 32.2 |
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(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(In $000s, except share amounts)
December 31, | March 31, | |||||||
2009 | 2010 | |||||||
(Unaudited) | ||||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | 11,493 | 24,200 | ||||||
Inventory | 145 | 107 | ||||||
Prepaid expenses and other current assets | 1,731 | 1,558 | ||||||
Total current assets | 13,369 | 25,865 | ||||||
Property, plant and equipment (net) | 901 | 715 | ||||||
Deposits and other assets | 196 | 196 | ||||||
Total assets | 14,466 | 26,776 | ||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | 1,709 | 1,782 | ||||||
Accrued liabilities and other current liabilities | 6,709 | 5,818 | ||||||
Warrant liability | 342 | 1,131 | ||||||
Other accrued restructuring charges | 1,062 | 780 | ||||||
Total current liabilities | 9,822 | 9,511 | ||||||
Total liabilities | 9,822 | 9,511 | ||||||
Stockholders’ equity: | ||||||||
Preferred stock, $0.001 par value; 5,000,000 shares authorized at December 31, 2009 and March 31, 2010; 2,046,813 and 1,923,413 shares issued and outstanding at December 31, 2009 and March 31, 2010, respectively. Aggregate preference in liquidation of $21,696,218 and $20,676,690 at December 31, 2009 and March 31, 2010, respectively. | 2 | 2 | ||||||
Common stock, $0.001 par value; 100,000,000 shares authorized at December 31, 2008 and March 31, 2009; 25,743,363 and 35,411,325 shares issued and outstanding at December 31, 2009 and March 31, 2010 | 26 | 35 | ||||||
Additional paid-in capital | 226,881 | 244,991 | ||||||
Accumulated other comprehensive income | 20 | 52 | ||||||
Deficit accumulated during the development stage | (222,285 | ) | (227,815 | ) | ||||
Total stockholders’ equity | 4,644 | 17,265 | ||||||
Total liabilities and stockholders’ equity | 14,466 | 26,776 | ||||||
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(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In $000s, except share and per share amounts)
(Unaudited)
Period from | ||||||||||||
August 13, 1996 | ||||||||||||
Three Months Ended | (inception) to | |||||||||||
March 31, | March 31, | |||||||||||
2009 | 2010 | 2010 | ||||||||||
(Restated) | (Restated) | |||||||||||
Revenues: | ||||||||||||
Collaboration and research and development revenue | — | — | 3,000 | |||||||||
Product revenue | 216 | 254 | 2,002 | |||||||||
Grant revenue | 12 | 17 | 3,652 | |||||||||
228 | 271 | 8,654 | ||||||||||
Operating expenses: | ||||||||||||
Cost of goods sold | 116 | 142 | 1,116 | |||||||||
Research and development | 3,097 | 2,178 | 172,357 | |||||||||
Selling, general and administrative | 2,230 | 2,402 | 74,248 | |||||||||
Goodwill and intangible impairment | — | — | 7,934 | |||||||||
Restructuring costs | — | — | 2,634 | |||||||||
Total operating expenses | 5,443 | 4,722 | 258,289 | |||||||||
Operating loss | (5,215 | ) | (4,451 | ) | (249,635 | ) | ||||||
Other income (expense): | ||||||||||||
Costs associated with aborted 2004 IPO | — | — | (3,550 | ) | ||||||||
Payment under guarantee | — | — | (1,652 | ) | ||||||||
Change in valuation of derivative | — | — | (308 | ) | ||||||||
Change in valuation of warrants | (8 | ) | (789 | ) | 5,575 | |||||||
Foreign exchange (losses)/gains | (137 | ) | 11 | (4,176 | ) | |||||||
Interest income | 46 | 9 | 13,652 | |||||||||
Interest expense | (107 | ) | (24 | ) | (4,657 | ) | ||||||
Total other income (expense) | (206 | ) | (793 | ) | 4,884 | |||||||
Loss before taxes | (5,421 | ) | (5,244 | ) | (244,751 | ) | ||||||
Income tax benefit | 358 | 133 | 17,355 | |||||||||
Net loss | (5,063 | ) | (5,111 | ) | (227,396 | ) | ||||||
Dividends on preferred ordinary shares | — | — | (38,123 | ) | ||||||||
Deemed dividend on convertible exchangeable preferred shares | — | (419 | ) | (419 | ) | |||||||
Dividend on convertible exchangeable preferred shares | (307 | ) | (289 | ) | (2,846 | ) | ||||||
Net loss applicable to common shareholders | (5,370 | ) | (5,819 | ) | (268,784 | ) | ||||||
Net loss per share — Basic and diluted | $ | (0.26 | ) | $ | (0.18 | ) | ||||||
Weighted average common shares outstanding | 20,433,129 | 31,721,822 | ||||||||||
�� |
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(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In $000s)
(Unaudited)
Period from | ||||||||||||
August 13, 1996 | ||||||||||||
Three Months Ended | (inception) to | |||||||||||
March 31, | March 31, | |||||||||||
2009 | 2010 | 2010 | ||||||||||
(Restated) | ||||||||||||
Cash flows from operating activities: | ||||||||||||
Net loss | (5,063 | ) | (5,111 | ) | (227,396 | ) | ||||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||
Accretion of interest on notes payable, net of amortization of debt premium | 21 | 2 | 102 | |||||||||
Amortization of investment premiums, net | 20 | — | (2,297 | ) | ||||||||
Change in valuation of derivative | — | — | 308 | |||||||||
Change in valuation of warrants | 8 | 789 | (5,619 | ) | ||||||||
Warrant re-pricing | — | — | 44 | |||||||||
Depreciation and amortization | 186 | 128 | 11,985 | |||||||||
Amortization of intangible assets | — | — | 886 | |||||||||
Fixed asset impairment | — | — | 221 | |||||||||
Goodwill and intangibles impairment | — | — | 7,934 | |||||||||
Unrealized foreign exchange loss | — | — | 7,747 | |||||||||
Deferred revenue | — | — | (98 | ) | ||||||||
Compensation for warrants issued to non employees | — | — | 1,215 | |||||||||
Shares issued for IP rights | — | — | 446 | |||||||||
(Gain) loss on disposal of property, plant and equipment | (10 | ) | (9 | ) | 103 | |||||||
Stock based compensation | (180 | ) | 319 | 16,714 | ||||||||
Provision for restructuring | — | — | 1,779 | |||||||||
Amortization of issuance costs of Preferred Ordinary “C” shares | — | — | 2,517 | |||||||||
Changes in operating assets and liabilities: | ||||||||||||
Prepaid expenses and other current assets | 303 | 211 | (537 | ) | ||||||||
Accounts payable and other current liabilities | (78 | ) | (1,100 | ) | (3,924 | ) | ||||||
Net cash used in operating activities | (4,793 | ) | (4,771 | ) | (187,870 | ) | ||||||
Investing activities: | ||||||||||||
Purchase of ALIGN | — | — | (3,763 | ) | ||||||||
Purchase of property, plant and equipment | (2 | ) | (5 | ) | (8,828 | ) | ||||||
Proceeds from sale of property, plant and equipment | 13 | 35 | 152 | |||||||||
Purchase of short-term investments | — | — | (156,657 | ) | ||||||||
Redemptions of short-term investments, net of maturities | 1,483 | — | 162,729 | |||||||||
Net cash provided by (used in) investing activities | 1,494 | 30 | (6,367 | ) | ||||||||
Financing activities: | ||||||||||||
Payment of capital lease obligations | — | — | (3,719 | ) | ||||||||
Proceeds from issuance of ordinary and preferred ordinary shares, net of issuance costs | — | — | 90,858 | |||||||||
Proceeds from issuance of common stock and warrants, net of issuance costs | — | 14,933 | 94,761 | |||||||||
Net proceeds from stock options and warrants exercised | — | 2,663 | 2,833 | |||||||||
Payment of preferred stock dividend | (307 | ) | — | (1,534 | ) |
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(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In $000s)
(Unaudited)
Period from | ||||||||||||
August 13, 1996 | ||||||||||||
Three Months Ended | (inception) to | |||||||||||
March 31, | March 31, | |||||||||||
2009 | 2010 | 2010 | ||||||||||
(Restated) | ||||||||||||
Repayment of government loan | — | — | (455 | ) | ||||||||
Government loan received | — | — | 414 | |||||||||
Loan received from Cyclacel Group Plc | — | — | 9,103 | |||||||||
Proceeds of committable loan notes issued from shareholders | — | — | 8,883 | |||||||||
Loans received from shareholders | — | — | 1,645 | |||||||||
Cash and cash equivalents assumed on stock purchase | — | — | 17,915 | |||||||||
Costs associated with stock purchase | — | — | (1,951 | ) | ||||||||
Net cash (used in) provided by financing activities | (307 | ) | 17,596 | 218,753 | ||||||||
Effect of exchange rate changes on cash and cash equivalents | (172 | ) | (148 | ) | (316 | ) | ||||||
Net (decrease) increase in cash and cash equivalents | (3,778 | ) | 12,707 | 24,200 | ||||||||
Cash and cash equivalents at beginning of period | 24,220 | 11,493 | — | |||||||||
Cash and cash equivalents at end of period | 20,442 | 24,200 | 24,200 | |||||||||
Supplemental disclosure of cash flows information: | ||||||||||||
Cash received during the period for: | ||||||||||||
Interest | 30 | 5 | 11,709 | |||||||||
Taxes | — | 110 | 16,550 | |||||||||
Cash paid during the period for: | ||||||||||||
Interest | — | — | (1,759 | ) | ||||||||
Schedule of non-cash transactions: | ||||||||||||
Acquisitions of equipment purchased through capital leases | — | — | 3,470 | |||||||||
Issuance of Ordinary shares in connection with license agreements | — | — | 592 | |||||||||
Issuance of Ordinary shares on conversion of bridging loan | — | — | 1,638 | |||||||||
Issuance of Preferred Ordinary “C” shares on conversion of secured convertible loan notes and accrued interest | — | — | 8,893 | |||||||||
Issuance of Ordinary shares in lieu of cash bonus | — | — | 164 | |||||||||
Issuance of other long term payable on ALIGN acquisition | — | — | 1,122 | |||||||||
Dividends accrued but not paid on convertible exchangeable preferred shares | — | 215 | 1,443 | |||||||||
Deemed dividend on conversion of exchangeable preferred shares | — | 419 | 419 |
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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
• | Acute myeloid leukemia, or AML in the elderly; | ||
• | Myelodysplastic syndromes, or MDS; and | ||
• | Non-small cell lung cancer or NSCLC. |
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March 31, | March 31, | |||||||
2009 | 2010 | |||||||
Stock options | 3,680,684 | 3,300,351 | ||||||
Restricted stock and restricted stock units | 141,700 | 83,330 | ||||||
Convertible preferred stock | 870,980 | 818,470 | ||||||
Common stock warrants | 3,808,841 | 5,843,597 | ||||||
Total shares excluded from calculation | 8,502,205 | 10,045,748 | ||||||
• | 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. |
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Level 1 | Level 2 | Level 3 | Total | |||||||||||||
$000 | $000 | $000 | $000 | |||||||||||||
Warrants | — | 342 | — | 342 | ||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
$000 | $000 | $000 | $000 | |||||||||||||
Warrants | — | 1,131 | — | 1,131 | ||||||||||||
December 31, | March 31, | |||||||
2009 | 2010 | |||||||
($000s) | ||||||||
Research and development tax credit receivable | 1,096 | 1,059 | ||||||
Prepayments | 456 | 268 | ||||||
Other current assets | 179 | 231 | ||||||
Total prepaid expenses and other current assets | 1,731 | 1,558 | ||||||
December 31, | March 31, | |||||||
2009 | 2010 | |||||||
($000s) | ||||||||
Accrued research and development | 2,654 | 2,572 | ||||||
Accrued IP / Patent costs | 283 | 275 | ||||||
Accrued compensation | 136 | 152 | ||||||
Amount payable under license agreement | 651 | 658 | ||||||
Amount payable under guarantee (1) | 796 | — | ||||||
Preferred dividend | 1,228 | 1,443 | ||||||
Other current liabilities | 961 | 718 | ||||||
6,709 | 5,818 | |||||||
(1) | For more information please see Footnote number #7 “Commitments and Contingencies — Guarantee.” |
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For the three months | ||||||||
ended March 31, | ||||||||
2009 | 2010 | |||||||
($000s) | ||||||||
Research and development | (34 | ) | 72 | |||||
General and administrative | (146 | ) | 247 | |||||
Stock-based compensation costs before income taxes | (180 | ) | 319 | |||||
Weighted | ||||||||||||||||
Average | ||||||||||||||||
Weighted | Remaining | Aggregate | ||||||||||||||
Average | Contractual | Intrinsic | ||||||||||||||
Options | Exercise Price | Term (years) | Value | |||||||||||||
(in $000s) | ||||||||||||||||
Options outstanding at December 31, 2009 | 3,349,876 | $ | 4.21 | 7.76 | 698 | |||||||||||
Granted | 192,000 | $ | 2.39 | |||||||||||||
Exercised | (39,277 | ) | $ | 0.44 | ||||||||||||
Expired | — | |||||||||||||||
Cancelled / forfeited | (202,248 | ) | $ | 5.24 | ||||||||||||
Options outstanding at March 31, 2010 | 3,300,351 | $ | 4.11 | 7.67 | 1,860 | |||||||||||
Unvested at March 31, 2010 | 1,321,103 | $ | 2.62 | 8.43 | 1,092 | |||||||||||
Vested and exercisable at March 31, 2010 | 1,979,248 | $ | 5.10 | 7.16 | 768 | |||||||||||
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For the three months | ||||||||
ended March 31, | ||||||||
2009 | 2010 | |||||||
Expected term | 5 Yrs | 5 - 6Yrs | ||||||
Risk free interest rate | 1.65 - 1.84 | % | 2.37 - 2.96 | % | ||||
Expected volatility | 85 | % | 90 - 100 | % | ||||
Expected dividend yield over expected term | — | — | ||||||
Resulting weighted average grant fair value | $ | 0.39 | $ | 1.80 |
Weighted Average Grant | ||||||||
Restricted Stock | Date Value Per Share | |||||||
Non-vested at December 31, 2009 | 36,458 | $ | 0.44 | |||||
Vested | (3,126 | ) | $ | 0.44 | ||||
Non-vested at March 31, 2010 | 33,332 | $ | 0.44 |
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Weighted Average Grant | ||||||||
Restricted Stock Units | Date Value Per Share | |||||||
Non-vested at December 31, 2009 | 54,687 | $ | 0.44 | |||||
Vested | (4,689 | ) | $ | 0.44 | ||||
Non-vested at March 31, 2010 | 49,998 | $ | 0.44 |
$000s | ||||
Restructuring provision at December 31, 2009 | 1,062 | |||
Restructuring expense for the current period | — | |||
Payments made in the period | (282 | ) | ||
As of March 31, 2010 | 780 | |||
Less: amounts due within one year | (780 | ) | ||
Other accrued restructuring charges — long term | — |
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For the three months ended | ||||
March 31, 2010 | ||||
Preferred shares exchanged | 123,400 | |||
Common shares issued: | ||||
At stated convertible option | 52,510 | |||
Incremental shares issued under an inducement offer | 186,886 | |||
Total common shares issued: | 239,396 | |||
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Weighted | ||||||||||||
Expiration | Common Shares | Average | ||||||||||
Issued in Connection With | Date | Issuable | Exercise Price | |||||||||
March 2006 stock issuance | 2013 | 2,571,429 | 7.00 | |||||||||
February 2007 stock issuance | 2014 | 1,062,412 | 8.44 | |||||||||
December 2007 CEFF | 2012 | 100,000 | 1.40 | |||||||||
July 2009 Series II stock issuance | 2014 | 692,256 | 1.00 | |||||||||
January 2010 stock Issuance | 2015 | 712,500 | 3.26 | |||||||||
January 2010 stock Issuance | 2015 | 705,000 | 2.85 | |||||||||
Total | 5,843,597 | $ | 5.50 | |||||||||
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• | Acute myeloid leukemia, or AML in the elderly; | ||
• | Myelodysplastic syndromes, or MDS; and | ||
• | Non-small cell lung cancer or NSCLC. |
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Three months ended March 31, | ||||||||||||||||
2009 | 2010 | Difference | Difference | |||||||||||||
($000s) | % | |||||||||||||||
Product revenue | 216 | 254 | 38 | 18 | ||||||||||||
Grant revenue | 12 | 17 | 5 | 42 | ||||||||||||
Total revenue | 228 | 271 | 43 | 19 | ||||||||||||
Three months ended March 31, | ||||||||||||||||
2009 | 2010 | Difference | Difference | |||||||||||||
($000s) | % | |||||||||||||||
Cost of goods sold | 116 | 142 | 26 | 22 | ||||||||||||
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• | clinical trial and regulatory-related costs; | ||
• | payroll and personnel-related expenses, including consultants and contract research; | ||
• | preclinical studies and laboratory supplies and materials; | ||
• | technology license costs; and | ||
• | rent and facility expenses for our laboratories. |
Three months ended March 31, | ||||||||||||||||
2009 | 2010 | Difference | Difference | |||||||||||||
($000s) | % | |||||||||||||||
Sapacitabine | 1,866 | 1,622 | (244 | ) | (13 | ) | ||||||||||
Seliciclib | 267 | 61 | (206 | ) | (77 | ) | ||||||||||
CYC116 | 121 | 16 | (105 | ) | (87 | ) | ||||||||||
Other research and development costs | 843 | 479 | (364 | ) | (43 | ) | ||||||||||
Total research and development expenses | 3,097 | 2,178 | (919 | ) | (30 | ) | ||||||||||
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Three months ended March 31, | ||||||||||||||||
2009 | 2010 | Difference | Difference | |||||||||||||
($000s) | % | |||||||||||||||
Total selling, general and administrative expenses | 2,230 | 2,402 | 172 | 8 | ||||||||||||
Three months ended March 31, | ||||||||||||||||
2009 | 2010 | Difference | Difference | |||||||||||||
($000s) | % | |||||||||||||||
Change in valuation of warrants | (8 | ) | (789 | ) | (781 | ) | (9,763 | ) | ||||||||
Foreign exchange losses | (137 | ) | 11 | 148 | 108 | |||||||||||
Interest income | 46 | 9 | (37 | ) | (80 | ) | ||||||||||
Interest expense | (107 | ) | (24 | ) | 83 | 78 | ||||||||||
Total other income (expense) | (206 | ) | (793 | ) | (587 | ) | (285 | ) | ||||||||
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Three months ended March 31, | ||||||||||||||||
2009 | 2010 | Difference | Difference | |||||||||||||
($000s) | % | |||||||||||||||
Total income tax benefit | 358 | 133 | (225 | ) | (63 | ) | ||||||||||
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December 31, | March 31, | % | ||||||||||||||
2009 | 2010 | $ Difference | Difference | |||||||||||||
($000s) | ||||||||||||||||
Cash and cash equivalents | $ | 11,493 | 24,200 | 12,707 | 111 | |||||||||||
Total cash and cash equivalents and short-term investments | 11,493 | 24,200 | 12,707 | 111 | ||||||||||||
Current assets | 13,369 | 25,865 | (12,496 | ) | (93 | ) | ||||||||||
Current liabilities | 9,822 | 9,511 | (311 | ) | 3 | |||||||||||
Working capital | 3,547 | 16,354 | 12,807 | 361 | ||||||||||||
Three months ended March 31, | ||||||||
2009 | 2010 | |||||||
($000s) | ||||||||
Net cash used in operating activities | (4,793 | ) | (4,771 | ) | ||||
Net cash provided by investing activities | 1,494 | 30 | ||||||
Net cash (used in) provided by financing activities | (307 | ) | 17,596 |
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• | the rate of progress and cost of our clinical trials, preclinical studies and other discovery and research and development activities; | ||
• | the costs associated with establishing manufacturing and commercialization capabilities; | ||
• | the costs of acquiring or investing in businesses, product candidates and technologies; | ||
• | the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; | ||
• | the costs and timing of seeking and obtaining FDA and other regulatory approvals; | ||
• | the effect of competing technological and market developments; and | ||
• | the economic and other terms and timing of any collaboration, licensing or other arrangements into which we may enter. |
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• | fund research and development and clinical trials connected with our research; | ||
• | fund clinical trials and seek regulatory approvals; | ||
• | build or access manufacturing and commercialization capabilities; | ||
• | implement additional internal control systems and infrastructure; | ||
• | commercialize and secure coverage, payment and reimbursement of our drug candidates, if any such candidates receive regulatory approval; | ||
• | maintain, defend and expand the scope of our intellectual property; and | ||
• | hire additional management, sales and scientific personnel. |
• | the scope, rate of progress and cost of our clinical trials and other research and development activities; | ||
• | the costs and timing of seeking and obtaining regulatory approvals; | ||
• | the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; | ||
• | the costs associated with establishing sales and marketing capabilities; |
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• | the effect of competing technological and market developments; and | ||
• | the payment, other terms and timing of any strategic alliance, licensing or other arrangements that we may establish. |
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• | delays in securing clinical investigators or trial sites for our clinical trials; | ||
• | delays in obtaining institutional review board, or IRB, and other regulatory approvals to commence a clinical trial; | ||
• | slower than anticipated rates of patient recruitment and enrollment, or reaching the targeted number of patients because of competition for patients from other trials or other reasons; | ||
• | negative or inconclusive results from clinical trials; | ||
• | unforeseen safety issues; | ||
• | uncertain dosing issues may or may not be related to suboptimal pharmacokinetic and pharmacodynamic behaviors; | ||
• | approval and introduction of new therapies or changes in standards of practice or regulatory guidance that render our clinical trial endpoints or the targeting of our proposed indications obsolete; | ||
• | inability to monitor patients adequately during or after treatment or problems with investigator or patient compliance with the trial protocols; | ||
• | inability to replicate in large controlled studies safety and efficacy data obtained from a limited number of patients in uncontrolled trials; | ||
• | inability or unwillingness of medical investigators to follow our clinical protocols; and | ||
• | unavailability of clinical trial supplies. |
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• | we may not be able to control the amount and timing of resources that our collaborators may devote to the drug candidates; | ||
• | our collaborators may experience financial difficulties; | ||
• | we may be required to relinquish important rights such as marketing and distribution rights; business combinations or significant changes in a collaborator’s business strategy may also adversely affect a collaborator’s willingness or ability to complete our obligations under any arrangement; | ||
• | a collaborator could independently move forward with a competing drug candidate developed either independently or in collaboration with others, including our competitors; and | ||
• | collaborative arrangements are often terminated or allowed to expire, which would delay the development and may increase the cost of developing our drug candidates. |
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• | those discussed in the risk factor which immediately follows; |
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• | the fact that the FDA or other regulatory officials may not approve our or our third party manufacturer’s processes or facilities; or | ||
• | the fact that new regulations may be enacted by the FDA or other regulators may change their approval policies or adoption of new regulations requiring new or different evidence of safety and efficacy for the intended use of a drug candidate. |
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A large number of drug candidates are in development for the treatment of leukemia, lung cancer, lymphomas and nasopharyngeal cancer. Several pharmaceutical and biotechnology companies have nucleoside analogs or other products on the market or in clinical trials which may be competitive to sapacitabine in both hematological and oncology indications. These include Celgene, Cephalon, Eisai, Johnson & Johnson, Eli Lilly, Genzyme, GlaxoSmithKline, Hospira, Pfizer, Seattle Genetics, Sunesis and Vion. We believe that we are currently the only company that has an orally available CDK-specific agent in Phase 2 clinical trials but that there are a number of companies, including AstraZeneca, Eisai, Pfizer, Piramal Life Sciences, Roche, Merck and Bayer-Schering that are developing CDK inhibitors in early stage clinical trials in cancer patients. Although Aventis, a predecessor of Sanofi-Aventis, had previously announced that it has ceased Phase 2 development of alvocidib or flavopiridol, a CDK inhibitor, we believe that the National Cancer Institute’s Cancer Therapy Evaluation Program, or CTEP, is continuing to enroll patients in a CTEP sponsored trial in patients with chronic leukemia. A number of companies are pursuing discovery and research activities in each of the other areas that are the subject of our research and drug development programs. We believe that AstraZeneca, Entremed, Merck, jointly with Vertex, Nerviano Medical Sciences, Pfizer, Rigel, Sunesis and Takeda-Millennium have commenced Phase 1 or Phase 2 clinical trials of Aurora kinase inhibitors in patients with advanced cancers. Several companies have reported selection of Aurora kinase inhibitor candidates for development and may have started or are expected to start clinical trials within the next twelve months. We believe that Boehringer Ingelheim, GlaxoSmithKline, Onconova and Nerviano Medical Sciences have commenced Phase 1 or Phase 2 clinical trials with Plk inhibitor candidates for oncology indications. For our ALIGN products, we believe that Beiersdorf, Daiichi-Sankyo, Eisai, Johnson & Johnson, MPM Medical and other companies market products for radiation dermatitis and xerostomia.
• | developing drug candidates; | ||
• | conducting preclinical and clinical trials; | ||
• | obtaining regulatory approvals; and | ||
• | commercializing product candidates. |
• | timing of market introduction, number and clinical profile of competitive drugs; |
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• | our ability to provide acceptable evidence of safety and efficacy; | ||
• | relative convenience and ease of administration; | ||
• | cost-effectiveness; | ||
• | availability of coverage, reimbursement and adequate payment from health maintenance organizations and other third party payors; | ||
• | prevalence and severity of adverse side effects; and | ||
• | other potential advantages over alternative treatment methods. |
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• | be prohibited from selling or licensing any product that we may develop unless the patent holder licenses the patent to us, which it is not required to do; | ||
• | be required to pay substantial royalties or grant a cross license to our patents to another patent holder; | ||
• | decide to move some of our screening work outside Europe; | ||
• | be required to pay substantial damages for past infringement, which we may have to pay if a court determines that our product candidates or technologies infringe a competitor’s patent or other proprietary rights; or | ||
• | be required to redesign the formulation of a drug candidate so it does not infringe, which may not be possible or could require substantial funds and time. |
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• | disclosure of actual or potential clinical results with respect to product candidates we are developing; | ||
• | regulatory developments in both the United States and abroad; | ||
• | developments concerning proprietary rights, including patents and litigation matters; | ||
• | public concern about the safety or efficacy of our product candidates or technology, or related technology, or new technologies generally; | ||
• | public announcements by our competitors or others; and | ||
• | general market conditions and comments by securities analysts and investors. |
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• | authorize the issuance of preferred stock that can be created and issued by the Board of Directors without prior stockholder approval, commonly referred to as “blank check” preferred stock, with rights senior to those of our common stock; | ||
• | provide for the Board of Directors to be divided into three classes; and | ||
• | require that stockholder actions must be effected at a duly called stockholder meeting and prohibit stockholder action by written consent. |
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• | additions to or departures of our key personnel; | ||
• | announcements of technological innovations or new products or services by us or our competitors; | ||
• | announcements concerning our competitors or the biotechnology industry in general; | ||
• | new regulatory pronouncements and changes in regulatory guidelines; | ||
• | general and industry-specific economic conditions; | ||
• | changes in financial estimates or recommendations by securities analysts; | ||
• | variations in our quarterly results; | ||
• | announcements about our collaborators or licensors; and | ||
• | changes in accounting principles. |
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31.1 | Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rule 13a-14(a) As Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | |
31.2 | Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rule 13a-14(a) As Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | |
32.1 | Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | |
32.2 | Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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CYCLACEL PHARMACEUTICALS, INC. | ||||
Date: May 19, 2010 | By: | /s/ Paul McBarron | ||
Paul McBarron | ||||
Chief Operating Officer, Chief Financial Officer and Executive Vice President, Finance | ||||
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