Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Quarter Ended September 30, 2013
Or
¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 000-54852
CELATOR PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware | 20-2680869 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |
200 PrincetonSouth Corporate Center Suite 180 Ewing, New Jersey | 08628 | |
(Address of principal executive offices) | (Zip Code) |
(609)-243-0123
(Registrant’s telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in
Rule 12b-2 of the Exchange Act.
Large accelerated filer | ¨ | Accelerated filer | ¨ | |||
Non-accelerated filer | ¨ (Do not check if a smaller reporting company) | Smaller Reporting Company | x |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
The number of shares outstanding of the registrant’s common stock, $0.001 par value, as of November 6, 2013 was 26,026,793.
Table of Contents
CELATOR PHARMACEUTICALS, INC.
Page | ||||||
Part I. | FINANCIAL INFORMATION | |||||
Item 1. | Financial Statements (Unaudited) | |||||
Consolidated Balance Sheets as of September 30, 2013 and December 31, 2012 | 3 | |||||
4 | ||||||
5 | ||||||
7 | ||||||
Notes to Consolidated Financial Statements | 8 | |||||
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 15 | ||||
Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 20 | ||||
Item 4. | Controls and Procedures | 21 | ||||
Part II. | OTHER INFORMATION | |||||
Item 1. | Legal Proceedings | 22 | ||||
Item 1A. | Risk Factors | 22 | ||||
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 22 | ||||
Item 6. | Exhibits | 22 | ||||
Signature | ||||||
Certifications |
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Table of Contents
Part I. Financial Information
Item 1. Financial Statements
Celator Pharmaceuticals, Inc. and Subsidiaries
(A development stage company)
(Unaudited)
September 30, 2013 | December 31, 2012 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 27,641,470 | $ | 9,648,008 | ||||
Restricted cash | 288,861 | 40,205 | ||||||
Other receivables | 9,425 | 2,000,357 | ||||||
Prepaid expenses and deposits | 282,452 | 148,275 | ||||||
Assets held for sale | 74,086 | 251,269 | ||||||
Other current assets | 530,391 | — | ||||||
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Total current assets | 28,826,685 | 12,088,114 | ||||||
Property and equipment, net | 1,177,516 | 1,245,025 | ||||||
Other assets | 30,838 | 105,805 | ||||||
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Total assets | $ | 30,035,039 | $ | 13,438,944 | ||||
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Liabilities | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 677,193 | $ | 699,858 | ||||
Accrued liabilities | 1,402,735 | 1,194,998 | ||||||
Current portion of deferred revenue | 542,986 | 615,384 | ||||||
Current portion of loans | — | 1,200,000 | ||||||
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Total current liabilities | 2,622,914 | 3,710,240 | ||||||
Deferred revenue | 723,982 | 1,076,924 | ||||||
Deferred rent | 23,148 | — | ||||||
Loans payable | — | 1,800,000 | ||||||
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Total liabilities | 3,370,044 | 6,587,164 | ||||||
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Stockholders’ equity | ||||||||
Common stock | ||||||||
Authorized 255,000,000 shares, par value $0.001 Issued and outstanding 26,026,793 shares as of September 30, 2013 and 13,673,160 shares as of December 31, 2012 | 26,027 | 13,673 | ||||||
Warrants | 1,083,193 | 1,083,193 | ||||||
Additional paid-in capital | 155,712,593 | 118,509,395 | ||||||
Accumulated other comprehensive loss | (1,133,266 | ) | (1,133,266 | ) | ||||
Deficit accumulated during the development stage | (129,023,552 | ) | (111,621,215 | ) | ||||
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Total stockholders’ equity | 26,664,995 | 6,851,780 | ||||||
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Total liabilities and stockholders’ equity | $ | 30,035,039 | $ | 13,438,944 | ||||
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See accompanying notes to consolidated financial statements.
3
Table of Contents
Celator Pharmaceuticals, Inc. and Subsidiaries
(A development stage company)
Consolidated Statement of Loss and Comprehensive Loss
(Unaudited)
Three months ended September 30 | Nine months ended September 30 | November 18, 1999 (inception) to | ||||||||||||||||||
2013 | 2012 | 2013 | 2012 | September 30, 2013 | ||||||||||||||||
Expenses | ||||||||||||||||||||
Research and development | $ | 2,325,891 | $ | 1,512,855 | $ | 5,995,866 | $ | 3,295,702 | $ | 86,413,531 | ||||||||||
Leukemia & Lymphoma Society funding | (135,746 | ) | (153,846 | ) | (425,339 | ) | (288,846 | ) | (5,881,761 | ) | ||||||||||
Research collaboration income | — | — | — | (19,440 | ) | (2,240,720 | ) | |||||||||||||
General and administrative | 1,434,436 | 945,926 | 3,922,084 | 2,845,095 | 41,122,804 | |||||||||||||||
(Gain) loss on disposal of property and equipment | (12,059 | ) | 30,853 | 126,633 | 50,352 | 898,719 | ||||||||||||||
Amortization and depreciation | 51,239 | 80,977 | 148,291 | 252,656 | 4,822,521 | |||||||||||||||
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Operating loss | (3,663,761 | ) | (2,416,765 | ) | (9,767,535 | ) | (6,135,519 | ) | (125,135,094 | ) | ||||||||||
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Other income (expenses) | ||||||||||||||||||||
Foreign exchange (loss) gain | (16,745 | ) | — | (21,229 | ) | (12,413 | ) | 522,019 | ||||||||||||
Interest and miscellaneous income | 3,094 | (4,763 | ) | 6,560 | 2,127 | 2,768,529 | ||||||||||||||
Gain on settlement in exchange of preferred stock | — | 268 | — | — | 1,562,689 | |||||||||||||||
Non-cash derivative instrument charge | — | — | (7,473,108 | ) | — | (7,473,108 | ) | |||||||||||||
Interest expense | — | (3,793,634 | ) | (147,025 | ) | (4,220,970 | ) | (6,036,317 | ) | |||||||||||
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Loss before income taxes | (3,677,412 | ) | (6,214,894 | ) | (17,402,337 | ) | (10,366,775 | ) | (133,791,282 | ) | ||||||||||
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Income tax benefit | — | — | — | — | 6,243,583 | |||||||||||||||
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Net loss incurred in the development stage | (3,677,412 | ) | (6,214,894 | ) | (17,402,337 | ) | (10,366,775 | ) | (127,547,699 | ) | ||||||||||
Other comprehensive loss attributable to foreign exchange translation | — | — | — | — | (1,133,266 | ) | ||||||||||||||
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Comprehensive loss | (3,677,412 | ) | (6,214,894 | ) | (17,402,337 | ) | (10,366,775 | ) | (128,680,965 | ) | ||||||||||
Accretion on preferred stock | — | — | — | — | (1,475,853 | ) | ||||||||||||||
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Total comprehensive loss attributable to common stockholders | (3,677,412 | ) | (6,214,894 | ) | (17,402,337 | ) | (10,366,775 | ) | (130,156,818 | ) | ||||||||||
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Net loss incurred in the development stage | (3,677,412 | ) | (6,214,894 | ) | (17,402,337 | ) | (10,366,775 | ) | (127,547,699 | ) | ||||||||||
Accretion on preferred stock | — | — | — | — | (1,475,853 | ) | ||||||||||||||
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Net loss attributable to common stockholders | $ | (3,677,412 | ) | $ | (6,214,894 | ) | $ | (17,402,337 | ) | $ | (10,366,775 | ) | $ | (129,023,552 | ) | |||||
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Net loss per share | ||||||||||||||||||||
Basic and diluted | $ | (0.14 | ) | $ | (0.47 | ) | $ | (0.87 | ) | $ | (0.87 | ) | ||||||||
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Weighted average of common shares outstanding | ||||||||||||||||||||
Basic and diluted | 26,026,793 | 13,319,077 | 19,977,071 | 11,931,885 | ||||||||||||||||
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See accompanying notes to consolidated financial statements.
4
Table of Contents
Celator Pharmaceuticals, Inc. and Subsidiaries
(A development stage company)
Consolidated Statements of Stockholders’ Equity
From November 18, 1999 (inception) to September 30, 2013
(Unaudited)
COMMON STOCK | RESTRICTED STOCK | WARRANTS | ADDITIONAL PAID-IN | ACCUMULATED OTHER COMPREHENSIVE | DEFICIT ACCUMULATED DURING THE DEVELOPMENT | STOCKHOLDERS’ | ||||||||||||||||||||||||||||||
NUMBER | AMOUNT | NUMBER | AMOUNT | AMOUNT | CAPITAL | LOSS | STAGE | EQUITY | ||||||||||||||||||||||||||||
Issued on incorporation | 25,802 | $ | 26 | — | $ | — | $ | — | $ | 3,230 | $ | — | $ | — | $ | 3,256 | ||||||||||||||||||||
Issued for technology | 1,602 | 2 | — | — | — | 200 | — | — | 202 | |||||||||||||||||||||||||||
Issued for cash, net of stock issuance costs | 8,479 | 8 | — | — | — | 402,689 | — | — | 402,697 | |||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | — | (1,987 | ) | — | (1,987 | ) | |||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | (200,050 | ) | (200,050 | ) | |||||||||||||||||||||||||
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Balance at December 31, 2000 | 35,883 | 36 | — | — | — | 406,119 | (1,987 | ) | (200,050 | ) | 204,118 | |||||||||||||||||||||||||
Issued for cash on exercise of stock options | 55 | — | — | — | — | 3,722 | — | — | 3,722 | |||||||||||||||||||||||||||
Issued for cash, net of stock issuance costs | 7,467 | 7 | — | — | — | 1,084,817 | — | — | 1,084,824 | |||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | — | (20,689 | ) | — | (20,689 | ) | |||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | (773,668 | ) | (773,668 | ) | |||||||||||||||||||||||||
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Balance at December 31, 2001 | 43,405 | 43 | — | — | — | 1,494,658 | (22,676 | ) | (973,718 | ) | 498,307 | |||||||||||||||||||||||||
Issued for cash, net of stock issuance costs | 1,118 | 1 | — | — | — | 137,735 | — | — | 137,736 | |||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | — | 13,861 | — | 13,861 | |||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | (1,497,719 | ) | (1,497,719 | ) | |||||||||||||||||||||||||
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Balance at December 31, 2002 | 44,523 | 44 | — | — | — | 1,632,393 | (8,815 | ) | (2,471,437 | ) | (847,815 | ) | ||||||||||||||||||||||||
Issued for cash - exercise of stock options | 3,522 | 4 | — | — | — | 8,513 | — | — | 8,517 | |||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | — | (484,668 | ) | — | (484,668 | ) | |||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | (3,506,027 | ) | (3,506,027 | ) | |||||||||||||||||||||||||
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Balance at December 31, 2003 | 48,045 | 48 | — | — | — | 1,640,906 | (493,483 | ) | (5,977,464 | ) | (4,829,993 | ) | ||||||||||||||||||||||||
Issued for cash - exercise of stock options | 6,410 | 6 | — | — | — | 15,464 | — | — | 15,470 | |||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | — | (811,423 | ) | — | (811,423 | ) | |||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | (5,445,046 | ) | (5,445,046 | ) | |||||||||||||||||||||||||
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Balance at December 31, 2004 | 54,455 | 54 | — | — | — | 1,656,370 | (1,304,906 | ) | (11,422,510 | ) | (11,070,992 | ) | ||||||||||||||||||||||||
Warrants issued on conversion of bridge loan | — | — | — | — | 425,000 | — | — | — | 425,000 | |||||||||||||||||||||||||||
Issued on reorganization | 844,173 | 844 | — | — | — | 9,495,846 | — | — | 9,496,690 | |||||||||||||||||||||||||||
Issued on conversion of debt | 246,864 | 247 | — | — | — | 2,776,897 | — | — | 2,777,144 | |||||||||||||||||||||||||||
Issued for cash, net of stock issue costs | 3,308,789 | 3,309 | — | — | — | 36,462,039 | — | — | 36,465,348 | |||||||||||||||||||||||||||
Issued for cash on exercise of stock options | 12,054 | 12 | — | — | — | 33,134 | — | — | 33,146 | |||||||||||||||||||||||||||
Issued for cash on exercise of warrants | 108 | — | — | — | — | 1,220 | — | — | 1,220 | |||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | — | 171,640 | — | 171,640 | |||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | (8,913,249 | ) | (8,913,249 | ) | |||||||||||||||||||||||||
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Balance at December 31, 2005 | 4,466,443 | 4,466 | — | — | 425,000 | 50,425,506 | (1,133,266 | ) | (20,335,759 | ) | 29,385,947 | |||||||||||||||||||||||||
Issued for cash on exercise of stock options | 1,705 | 2 | — | — | — | 4,675 | — | — | 4,677 | |||||||||||||||||||||||||||
Stock based compensation | — | — | — | — | — | 201,989 | — | — | 201,989 | |||||||||||||||||||||||||||
Net loss for the period | — | — | — | — | — | — | — | (14,588,786 | ) | (14,588,786 | ) | |||||||||||||||||||||||||
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Balance at December 31, 2006 | 4,468,148 | 4,468 | — | — | 425,000 | 50,632,170 | (1,133,266 | ) | (34,924,545 | ) | 15,003,827 | |||||||||||||||||||||||||
Issued for cash on exercise of stock options | 13,748 | 14 | — | — | — | 31,189 | — | — | 31,203 | |||||||||||||||||||||||||||
Stock based compensation | — | — | — | — | — | 243,340 | — | — | 243,340 | |||||||||||||||||||||||||||
Issued for cash, net of costs | 888,914 | 889 | — | — | — | 9,976,668 | — | — | 9,977,557 | |||||||||||||||||||||||||||
Net loss for the period | — | — | — | — | — | — | — | (16,761,805 | ) | (16,761,805 | ) | |||||||||||||||||||||||||
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Balance at December 31, 2007 | 5,370,810 | 5,371 | — | — | 425,000 | 60,883,367 | (1,133,266 | ) | (51,686,350 | ) | 8,494,122 |
See accompanying notes to consolidated financial statements.
5
Table of Contents
Issued for cash on exercise of stock options | 1,159 | 2 | - | - | - | 2,660 | - | - | 2,662 | |||||||||||||||||||||||||||
Stock based compensation | — | — | — | — | — | 186,578 | — | — | 186,578 | |||||||||||||||||||||||||||
Issued for cash | 1,334 | 1 | — | — | — | 4,498 | — | — | 4,499 | |||||||||||||||||||||||||||
Issued for cash, restricted stock | — | — | 4,000 | 4 | — | 13,497 | — | — | 13,501 | |||||||||||||||||||||||||||
Issued for cash, net of stock issue costs | 2,014,365 | 2,014 | — | — | — | 22,564,279 | — | — | 22,566,293 | |||||||||||||||||||||||||||
Net loss for the period | — | — | — | — | — | — | — | (14,028,617 | ) | (14,028,617 | ) | |||||||||||||||||||||||||
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Balance at December 31, 2008 | 7,387,668 | 7,388 | 4,000 | 4 | 425,000 | 83,654,879 | (1,133,266 | ) | (65,714,967 | ) | 17,239,038 | |||||||||||||||||||||||||
Issued for cash on exercise of stock options | 1,432 | 1 | — | — | — | 3,472 | — | — | 3,473 | |||||||||||||||||||||||||||
Stock based compensation | — | — | — | — | — | 200,522 | — | — | 200,522 | |||||||||||||||||||||||||||
Restricted stock transferred to common stock | 1,333 | 1 | (1,333 | ) | (1 | ) | — | — | — | — | — | |||||||||||||||||||||||||
Warrants issued on signing of loan agreement | — | — | — | — | 9,333 | — | — | — | 9,333 | |||||||||||||||||||||||||||
Net loss for the period | — | — | — | — | — | — | — | (10,022,979 | ) | (10,022,979 | ) | |||||||||||||||||||||||||
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Balance at December 31, 2009 | 7,390,433 | 7,390 | 2,667 | 3 | 434,333 | 83,858,873 | (1,133,266 | ) | (75,737,946 | ) | 7,429,387 | |||||||||||||||||||||||||
Issued for cash on exercise of stock options | 423 | — | — | — | — | 1,435 | — | — | 1,435 | |||||||||||||||||||||||||||
Stock based compensation | — | — | — | — | — | 169,424 | — | — | 169,424 | |||||||||||||||||||||||||||
Restricted stock transferred to common stock | 1,334 | 1 | (1,334 | ) | (2 | ) | — | — | — | — | (1 | ) | ||||||||||||||||||||||||
Warrants expired April 30, 2010 | — | — | — | — | (425,000 | ) | 425,000 | — | — | — | ||||||||||||||||||||||||||
Issued for cash, net of stock issue costs | 2,877,777 | 2,878 | — | — | — | 14,824,734 | — | — | 14,827,612 | |||||||||||||||||||||||||||
Net loss for the period | — | — | — | — | — | — | — | (10,814,788 | ) | (10,814,788 | ) | |||||||||||||||||||||||||
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Balance at December 31, 2010 | 10,269,967 | 10,269 | 1,333 | 1 | 9,333 | 99,279,466 | (1,133,266 | ) | (86,552,734 | ) | 11,613,069 | |||||||||||||||||||||||||
Stock based compensation | — | — | — | — | — | 114,089 | — | — | 114,089 | |||||||||||||||||||||||||||
Issued for cash, net of stock issue costs | 959,261 | 960 | — | — | — | 4,991,901 | — | — | 4,992,861 | |||||||||||||||||||||||||||
Restricted stock transferred to common stock | 1,333 | 1 | (1,333 | ) | (1 | ) | — | — | — | — | — | |||||||||||||||||||||||||
Net loss for the period | — | — | — | — | — | — | — | (14,159,754 | ) | (14,159,754 | ) | |||||||||||||||||||||||||
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Balance at December 31, 2011 | 11,230,561 | 11,230 | — | — | 9,333 | 104,385,456 | (1,133,266 | ) | (100,712,488 | ) | 2,560,265 | |||||||||||||||||||||||||
Issued for cash on exercise of stock options | 107 | — | — | — | — | 240 | — | — | 240 | |||||||||||||||||||||||||||
Stock based compensation | — | — | — | — | — | 3,210 | — | — | 3,210 | |||||||||||||||||||||||||||
Issued for cash, net of stock issuance costs | 1,202,276 | 1,203 | — | — | — | 5,924,062 | — | — | 5,925,265 | |||||||||||||||||||||||||||
Investor note converted to common stock | 1,240,216 | 1,240 | — | — | — | 6,840,904 | — | — | 6,842,144 | |||||||||||||||||||||||||||
Conversion of warrant liability and issuance of warrants | — | — | — | — | 1,073,860 | — | — | — | 1,073,860 | |||||||||||||||||||||||||||
Beneficial conversion option | — | — | — | — | — | 1,355,523 | — | — | 1,355,523 | |||||||||||||||||||||||||||
Net loss for the period | — | — | — | — | — | — | — | (10,908,727 | ) | (10,908,727 | ) | |||||||||||||||||||||||||
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Balance at December 31, 2012 | 13,673,160 | 13,673 | — | — | 1,083,193 | 118,509,395 | (1,133,266 | ) | (111,621,215 | ) | 6,851,780 | |||||||||||||||||||||||||
Stock based compensation | — | — | — | — | — | 322,069 | — | — | 322,069 | |||||||||||||||||||||||||||
Issued for cash, net of stock issuance costs | 12,353,633 | 12,354 | — | — | — | 29,408,021 | — | — | 29,420,375 | |||||||||||||||||||||||||||
Derivative liability reclassification (see Note 8) | — | — | — | — | — | 7,473,108 | — | — | 7,473,108 | |||||||||||||||||||||||||||
Net loss for the period | — | — | — | — | — | — | — | (17,402,337 | ) | (17,402,337 | ) | |||||||||||||||||||||||||
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Balance at September 30, 2013 | 26,026,793 | $ | 26,027 | — | $ | — | $ | 1,083,193 | $ | 155,712,593 | $ | (1,133,266 | ) | $ | (129,023,552 | ) | $ | 26,664,995 | ||||||||||||||||||
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See accompanying notes to consolidated financial statements.
6
Table of Contents
Celator Pharmaceuticals, Inc. and Subsidiaries
(A development stage company)
Consolidated Statements of Cash Flows
(Unaudited)
Nine months ended September 30, | November 18, 1999 (inception) to | |||||||||||
2013 | 2012 | September 30, 2013 | ||||||||||
Operating activities | ||||||||||||
Net loss | $ | (17,402,337 | ) | $ | (10,366,775 | ) | $ | (129,023,552 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities | ||||||||||||
Amortization and depreciation | 148,291 | 252,656 | 4,822,521 | |||||||||
Accretion on preferred stock | — | — | 1,475,853 | |||||||||
Non-cash stock-based compensation expense | 322,069 | 2,408 | 1,441,221 | |||||||||
Gain on settlement of preferred stock | — | — | (1,562,689 | ) | ||||||||
Loss on disposal of property and equipment | 126,633 | 50,352 | 898,720 | |||||||||
Non-cash derivative instrument charge | 7,473,108 | — | 7,473,108 | |||||||||
Non-cash financing costs | 74,751 | 4,193,698 | 4,771,178 | |||||||||
Changes in operating assets and liabilities | ||||||||||||
Other receivables | 1,990,932 | 1,113,711 | (9,425 | ) | ||||||||
Prepaid expenses and deposits | (134,177 | ) | (101,561 | ) | (282,452 | ) | ||||||
Restricted cash | (250,037 | ) | (1,859 | ) | (250,037 | ) | ||||||
Other current assets | (530,391 | ) | — | (530,391 | ) | |||||||
Other assets | — | (54,818 | ) | (105,805 | ) | |||||||
Accounts payable | (22,332 | ) | 322,238 | 677,529 | ||||||||
Accrued liabilities | 208,124 | 37,631 | 1,412,054 | |||||||||
Deferred rent liability | 23,148 | — | 23,148 | |||||||||
Deferred revenue | (425,339 | ) | 1,846,154 | 1,266,968 | ||||||||
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Cash used in operating activities | (8,397,557 | ) | (2,706,165 | ) | (107,502,051 | ) | ||||||
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Investing activities | ||||||||||||
Purchase of property and equipment | (82,009 | ) | (17,912 | ) | (7,420,007 | ) | ||||||
Proceeds on disposals of property and equipment | 51,776 | 31,402 | 447,164 | |||||||||
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Cash (used in) provided by investing activities | (30,233 | ) | 13,490 | (6,972,843 | ) | |||||||
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Financing activities | ||||||||||||
Proceeds from issuance of common stock and on options exercised | 32,499,986 | 6,221,345 | 41,015,267 | |||||||||
Proceeds from issuance of warrants and warrant derivatives | — | 242 | 500 | |||||||||
Proceeds from issuance of preferred stock | — | — | 102,157,702 | |||||||||
Payment of share issuance costs | (3,079,611 | ) | (781,931 | ) | (4,971,345 | ) | ||||||
Proceeds from loans payable | — | 5,423,390 | 17,898,295 | |||||||||
Repayments of capital lease obligation | — | — | (163,242 | ) | ||||||||
Repayments of loans payable | (3,000,000 | ) | — | (12,735,054 | ) | |||||||
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Cash provided by financing activities | 26,420,375 | 10,863,046 | 143,202,123 | |||||||||
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Effect of foreign exchange rate changes | 877 | — | (1,085,759 | ) | ||||||||
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Net change in cash | 17,993,462 | 8,170,371 | 27,641,470 | |||||||||
Cash and cash equivalents, beginning of period | 9,648,008 | 3,226,778 | — | |||||||||
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Cash and cash equivalents, end of period | $ | 27,641,470 | $ | 11,397,149 | $ | 27,641,470 | ||||||
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Supplemental disclosure of cash flow information | ||||||||||||
Interest paid | 79,388 | 21,847 | 1,123,204 | |||||||||
Income taxes paid | — | — | 172,451 | |||||||||
Property and equipment purchased under capital lease | — | — | 449,744 | |||||||||
Common stock issued on conversion of debt | — | 6,842,144 | 6,842,144 | |||||||||
Preferred stock issued on conversion of debt | — | — | 5,337,417 |
See accompanying notes to consolidated financial statements
7
Table of Contents
Celator Pharmaceuticals, Inc. and Subsidiaries
(A development stage company)
Notes to the Consolidated Financial Statements
(Unaudited)
1. | Nature of Business and Liquidity |
Celator Pharmaceuticals, Inc. (“Celator” or the “Company”) is a development stage company focused on new therapeutic products for cancer treatment using proprietary technology that recognizes and controls the delivery of efficacious fixed ratios of drug combinations to tumor sites.
The Company has incurred recurring losses and negative cash flows from operations since inception. As of September 30, 2013, the Company had an accumulated deficit of $129.0 million. The Company expects operating losses and negative cash flows to continue for the foreseeable future until such time, if ever, that it can generate significant revenues from its product candidates currently in development. At September 30, 2013, the Company had cash and cash equivalents of $27.6 million. Management believes that the cash and cash equivalents at September 30, 2013 will be sufficient to meet estimated working capital requirements and fund planned operations into the second half of 2015.
The Company is subject to those risks associated with any pharmaceutical company that has substantial expenditures for research and development. There can be no assurance that the Company’s research and development projects will be successful, that products developed will obtain necessary regulatory approval, or that any approved product will be commercially viable. In addition, the Company operates in an environment of rapid technological change and is largely dependent on the services of its employees and consultants.
2. | Summary of Significant Accounting Policies |
The accompanying unaudited consolidated financial statements and related disclosures have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and should be read in conjunction with the consolidated financial statements and notes included in Company’s Annual Report on Form 10-K for the year ended December 31, 2012. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) have been omitted.
In the opinion of management of the Company, the interim consolidated financial statements reflect all adjustments considered necessary for a fair presentation of the financial position, operating results and cash flows of the interim periods. All such adjustments are of a normal, recurring nature. The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the full year.
Basis of consolidation: The consolidated financial statements include the accounts of Celator and its wholly-owned subsidiaries, Celator Pharmaceuticals Corp. (“CPC”) and Celator UK Ltd. All intercompany transactions have been eliminated.
Use of estimates: The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Actual results may differ from those estimates. Significant areas requiring management estimates in the preparation of these consolidated financial statements include, among other things, assessment of other receivables, accrued liabilities, impairment and amortization of property and equipment, valuation allowance for deferred income taxes, valuation of stock-based compensation and contingencies.
New Accounting Pronouncement:In March 2013, the Financial Accounting Standards Board (“FASB”) issued an amendment to the accounting guidance on foreign currency matters in order to clarify the guidance for the release of cumulative translation adjustments. The guidance is effective for interim and annual periods beginning on or after December 15, 2013. The Company does not expect the adoption of this guidance will have a material impact on its consolidated financial statements.
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3. | Fair Value Measurements |
Financial instruments of the Company consist of cash deposits, money market investments, other receivables, accounts payable, certain accrued liabilities and debt. The carrying value of these financial instruments generally approximates fair value due to their short-term nature.
FASB Accounting Standards Codification (“ASC”) Topic 820,Fair Value Measurements establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. A financial instrument’s categorization within the fair value hierarchy is based upon the lowest level of input that is significant to the fair value measurement. ASC 820-10 establishes three levels of inputs that may be used to measure fair value:
Level 1 applies to assets or liabilities for which there are quoted prices in active markets for identical assets or liabilities.
Level 2 applies to assets or liabilities for which there are inputs, other than quoted prices included within Level 1, that are observable for the asset or liability, such as: quoted prices for similar assets or liabilities in active markets; quoted prices for identical assets or liabilities in markets with insufficient volume or infrequent transactions (less active markets); or model-derived valuations in which significant inputs are observable or can be derived principally from, or corroborated by, observable market data.
Level 3 applies to assets or liabilities for which there are unobservable inputs to the valuation methodology that are significant to the measurement of the fair value of the assets or liabilities.
ASC 820 requires disclosures about transfers into and out of Levels 1 and 2 and separate disclosures about purchases, sales, issuances, and settlements relating to Level 3 measurements. It also clarifies existing fair value disclosures regarding the level of disaggregation and the inputs and valuation techniques used to measure fair value.
The Company recognizes transfers between input levels as of the actual date of event. There were no transfers between levels and the following table provides the assets carried at fair value:
Fair Value | (Level 1) | (Level 2) | (Level 3) | |||||||||||||
September 30, 2013 | ||||||||||||||||
Assets: | ||||||||||||||||
Certificates of Deposit | $ | 15,001,448 | $ | 15,001,448 | ||||||||||||
Money Market Fund | 11,097,252 | 11,097,252 | ||||||||||||||
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Total | $ | 26,098,700 | $ | 26,098,700 | $ | — | $ | — | ||||||||
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December 31, 2012 | ||||||||||||||||
Assets: | ||||||||||||||||
Money Market Fund | $ | 9,107,500 | $ | 9,107,500 | $ | — | $ | — | ||||||||
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Table of Contents
4. | Other Receivables |
Other receivables as of September 30, 2013 and December 31, 2012, consist of the following:
September 30, 2013 | December 31, 2012 | |||||||
Receivables related to the sale of New Jersey net operating losses | $ | — | $ | 1,363,559 | ||||
Receivables related to value added tax recovery | — | 95,910 | ||||||
Receivables related to the Leukemia & Lymphoma Society funding | — | 500,000 | ||||||
Other receivables | 9,425 | 40,888 | ||||||
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$ | 9,425 | $ | 2,000,357 | |||||
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5. | Other Current Assets |
Other current assets as of September 30, 2013 and December 31, 2012 consist of the following:
September 30, 2013 | December 31, 2012 | |||||||
Clinical trial materials | $ | 530,391 | $ | — | ||||
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6. | Property and Equipment |
Property and equipment as of September 30, 2013 and December 31, 2012 including assets held under capital lease, consists of the following:
September 30, 2013 | December 31, 2012 | |||||||
Computer and equipment | $ | 125,373 | $ | 103,858 | ||||
Furniture and office equipment | 97,068 | 145,499 | ||||||
Laboratory equipment | 1,760,632 | 1,779,188 | ||||||
Capital lease equipment | 155,523 | 155,520 | ||||||
Leaseholds | 37,789 | 73,060 | ||||||
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2,176,385 | 2,257,125 | |||||||
Less: Accumulated depreciation | (998,869 | ) | (1,012,100 | ) | ||||
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$ | 1,177,516 | $ | 1,245,025 | |||||
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Three months ended September 30 | Nine months ended September 30 | |||||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||||
Depreciation and amortization | $ | 51,239 | $ | 80,977 | $ | 148,291 | $ | 252,656 | ||||||||
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In February 2012, the Company closed a laboratory in Canada and consigned certain property and equipment for sale with net book value of $507,622. At September 30, 2013 and December 31, 2012, the net book values of the remaining consigned equipment were $74,086 and $251,269, respectively, and consisted solely of scientific equipment which is presented as assets held for sale on the consolidated balance sheet.
During the nine months ended September 30, 2013 assets held for sale with a net book value of $177,428 were sold for proceeds of $51,776 resulting in a loss on disposal of $125,422.
During the nine months ended September 30, 2013, the Company wrote off other property and equipment and incurred a loss of $1,211.
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Table of Contents
7. | Accrued Liabilities |
Accrued liabilities as of September 30, 2013 and December 31, 2012:
September 30, 2013 | December 31, 2012 | |||||||
Accrued bonuses | $ | 481,429 | $ | 458,177 | ||||
Accrued salaries and vacation | 277,147 | 198,817 | ||||||
Accrued professional fees | 15,918 | 265,802 | ||||||
Accrued clinical trial expenses | 550,396 | 188,057 | ||||||
Accrued trade payables other | 77,845 | 84,145 | ||||||
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$ | 1,402,735 | $ | 1,194,998 | |||||
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8. | Stockholders’ Equity |
April 2013 Final Closing of Private Placement
On April 29, 2013, the Company entered into a securities purchase agreement and subscription agreements with certain accredited investors for the issuance and sale in the final round of a private placement of 10,430,034 shares of common stock, which the Company sold at a price of $3.116 per share for aggregate gross proceeds of $32,499,986. Warrants to purchase 0.28 shares of common stock at $3.58 per share were issued for each share of common stock purchased. The net proceeds totaled $29,420,375 for this financing.
In connection with this final closing of the financing, 1,923,599 shares of common stock and 161,327 warrants to purchase shares of common stock at $5.21 and 1,056,898 warrants to purchase shares of common stock at $3.58 per share were issued to certain existing stockholders of the Company who participated in earlier closings of this financing. The fair value of these common shares and warrants was recognized as a derivative liability with a corresponding charge to the statement of loss. The derivative liability was fair valued at $7,473,108 and the fair value was measured using significant unobservable inputs (Level 3). Upon the final closing of the April 2013 private placement, the derivative liability was reclassified into stockholders’ equity as the obligation to issue additional securities no longer existed.
Warrants
The following table summarizes the warrants outstanding to purchase common stock as of September 30, 2013:
Issue date | Number of warrants | Exercise price | Term | |||||||||
March 2009 | 12,445 | $ | 11.25 | 7 years | ||||||||
December 2011 | 123,585 | 5.21 | 7 years | |||||||||
February 2012 | 3,700 | 5.21 | 6 years | |||||||||
June 2012 | 17,267 | 5.21 | 7 years | |||||||||
August 2012 | 112,536 | 5.21 | 7 years | |||||||||
April 2013 | 161,327 | 5.21 | 7 years | |||||||||
April 2013 | 3,977,290 | 3.58 | 7 years | |||||||||
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4,408,150 | ||||||||||||
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11
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9. | Stock Based Compensation |
The following table provides a summary of option activity during the nine months ended September 30, 2013:
Number of options | Exercise price | |||||||
December 31, 2012 | 806,788 | $ | 2.52 | |||||
Granted | 1,549,150 | 3.12 | ||||||
Cancelled | (5,190 | ) | 2.42 | |||||
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September 30, 2013 | 2,350,748 | $ | 2.91 | |||||
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Exercisable at September 30, 2013 | 798,531 | $ | 2.52 |
The following table provides information regarding stock options activity during the periods:
Three months ended September 30 | Nine months ended September 30 | |||||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||||
Stock compensation expense recognized | $ | 235,289 | $ | 803 | $ | 322,069 | $ | 2,408 | ||||||||
Weighted average grant-date fair value of stock options issued (per share) | $ | 2.11 | $ | — | $ | 2.14 | $ | — | ||||||||
Grant-date fair value of stock options issued | $ | 59,080 | $ | — | $ | 3,314,341 | $ | — | ||||||||
Volatility | 117.0 | % | — | 118.3 | % | — | ||||||||||
Risk-free interest rate | 1.6 | % | — | 1.9 | % | — | ||||||||||
Dividend yield | 0 | % | — | 0 | % | — | ||||||||||
Expected life in years | 6.0 | — | 6.2 | — |
The grant-date fair value of stock options is estimated using the Black Scholes option pricing model. The Company determined the options’ life based on the simplified method and determined the options’ expected volatility based on peer group volatility and dividend yield based on the historical dividend payments. The risk free interest rate is based on the yield of an applicable term Treasury instrument.
The Company amortizes the grant-date fair value of stock options on a straight-line basis over the applicable requisite service periods of the awards, which is generally the vesting period. At September 30, 2013, the total compensation cost related to non-vested awards not yet recognized and weighted average period over which it will be recognized was $3,031,299 and 3.5 years, respectively.
10. | Geographic Segment Information |
The Company operates in the United States and Canada. The Company’s CPX-351 clinical trial materials are manufactured by a third party using the Company’s equipment located in Germany. Geographic net loss information is based on the location whereby the expenses were incurred. The geographic information about total assets is based on the physical location of the assets.
Total Assets | ||||||||
September 30, 2013 | December 31, 2012 | |||||||
United States | $ | 28,227,117 | $ | 11,578,590 | ||||
Canada | 701,664 | 717,250 | ||||||
Germany | 1,106,258 | 1,143,104 | ||||||
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Total Assets | $ | 30,035,039 | $ | 13,438,944 | ||||
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12
Table of Contents
Net Loss | ||||||||||||||||
Three months ended September 30 | Nine months ended September 30 | |||||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||||
United States | (3,274,731 | ) | (5,770,908 | ) | (15,649,089 | ) | (8,733,523 | ) | ||||||||
Canada | (402,681 | ) | (443,986 | ) | (1,753,248 | ) | (1,633,252 | ) | ||||||||
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Total Net Loss | $ | (3,677,412 | ) | $ | (6,214,894 | ) | $ | (17,402,337 | ) | $ | (10,366,775 | ) | ||||
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11. | Commitments and Contingencies |
In February 2013, the Company renewed its office lease agreements for office space in Vancouver, British Columbia, effective April 1, 2013 which expires in June 2016. The Company’s lease commitment is $226,000.
In March 2013, the Company entered into an office lease agreement for office space in Ewing, New Jersey, which commenced in July 2013 with a term of sixty months. The Company’s lease commitment is $643,000.
Under the Ewing, New Jersey lease agreement, the Company will be obligated to maintain a letter of credit from a bank with respect to its security deposit obligations in the amount of $200,000 during the first year of the Agreement, which amount will be reduced by $40,000 per year on each of December 1, 2014, 2015, and 2016 and by $60,000 on December 1, 2017.
The Company has a worldwide exclusive license agreement with Princeton University dated June 2007 that provides the Company with exclusive rights to some aspects of its nanoparticle polymer technology arising from research sponsored by the Company at Princeton University between 2003 and 2007. These inventions are generally characterized as particulate constructs for release of active agents for medical application. Of the products currently in Celator’s pipeline, only the hydrophobic docetaxel prodrug nanoparticle (HDPN) formulation is subject to this agreement. The Company is obligated to pay a royalty on net sales to Princeton University of a low single-digit percentage if any invention is sold by the Company or a company to which the product covered by the invention was licensed by the Company, which was generated under the exclusive licensing agreement. No royalty or other product/sub-license-related payments have been made to date. The Company is obligated to provide Princeton University a percentage within the range of 45% to 55% of proceeds obtained from a sub-license of the intellectual property to a third party in cases where the Company has not conducted any research or development activities and is solely licensing out the original intellectual property jointly developed by the Company and Princeton University. The Company may terminate the agreement at any time by giving 90 days written notice to Princeton University. Princeton may terminate the agreement if the Company should breach or fail to perform under the agreement, with written notice of default provided by Princeton University to the Company and only if the Company fails to cure the default within 60 days. The Company is obligated under the agreement to provide an annual progress report to Princeton University on any developments of the licensed technology as well as prosecution of the patents covering the technology and the use of commercially reasonable efforts to develop licensed products.
The Company has a collaborative research agreement dated May 2001 with the British Columbia Cancer Agency (“BCCA”) whereby in consideration for the license and conditional assignment of all Company-sponsored intellectual property to the Company by BCCA, the Company will pay to BCCA a royalty in the low single digits on net sales of royalty-bearing products in territories so long as a valid claim exists for inventions made between June 2000 and June 2005 under the agreement. All obligations relating to the conduct of the research and assignment of intellectual property have been completed. No payments of royalties have been made to date. Either party may terminate the agreement if the other party commits a material breach or default and such breach or default is not reasonably cured within 45 days.
In consideration of funding by the Leukemia & Lymphoma Society® (“LLS”) and transfer to the Company of any rights LLS may have to any project inventions developed during the term of the agreement, the Company may be required to pay LLS a multiple on the LLS funding, (LLS funding is the $5 million
13
Table of Contents
in support of the Phase 3 study in addition to the approximately $4.1 million the Company received in support of the Phase 2 study). Subject to exclusions under the agreement, the Company is obligated to pay LLS an amount equal to 50% of the cash payments the Company receives from out-licenses and transfers of rights to the product or other liquidity event, as defined in the agreement, until LLS has received an amount equal to 1.5 times the amount of funding the Company receives from LLS. The total amount payable by the Company to LLS will not exceed 3.55 times the amount of funding received from LLS, with the specific amount depending on when the payment(s) occur relative to the timing of the research program and product commercialization. The payments may take the form of cash payments or royalties (not to exceed 5% of net sales) but will not exceed the maximum amount referred to in the preceding sentence.
14
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Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations |
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This report and other written reports and oral statements made from time to time by the Company may contain so-called “forward-looking statements,” all of which are based on management’s current expectations and are subject to risks and uncertainties which may cause results to differ materially from those set forth in the statements. One can identify these forward-looking statements by their use of words such as “anticipates,” “expects,” “plans,” “will,” “estimates,” “forecasts,” “projects” and other words of similar meaning. One can also identify them by the fact that they do not relate strictly to historical or current facts. These statements are likely to address the Company’s growth strategy, financial results, product development, product approvals, product potential and development programs. One must carefully consider any such statement and should understand that many factors could cause actual results to differ materially from the Company’s forward-looking statements. These factors include inaccurate assumptions and a broad variety of other risks and uncertainties, including some that are known and some that are not. No forward-looking statement can be guaranteed and actual future results may vary materially.
The Company does not assume the obligation to update any forward-looking statement. One should carefully evaluate such statements in light of factors, including risk factors, described in the Company’s filings with the Securities and Exchange Commission (“SEC”), especially on Forms 10-K, 10-Q and 8-K. In Item 1A “Risk Factors” of the Company’s Annual Report on Form 10-K for the year ended December 31, 2012, the Company discusses in more detail various important risk factors that could cause actual results to differ from expected or historic results. The Company notes these factors for investors as permitted by the Private Securities Litigation Reform Act of 1995. One should understand that it is not possible to predict or identify all such factors. Consequently, the reader should not consider any such list to be a complete statement of all potential risks or uncertainties.
Overview
Celator Pharmaceuticals, Inc. (“Celator”), headquartered in Ewing, New Jersey, is a pharmaceutical company developing new and more effective therapies to treat cancer. Celator is currently focused on a clinical stage product, CPX-351 for the treatment of secondary acute myeloid leukemia (AML). Celator also has operations in Vancouver, British Columbia, Canada which are managed in the wholly-owned subsidiary, Celator Pharmaceuticals Corp. Celator has 20 full-time employees, of whom seven hold Ph.D.’s or M.D.’s in their respective areas of expertise.
CombiPlex®, Celator’s drug ratio technology, is a distinct nano-scale drug delivery technology platform based on liposomes and nanoparticles. Celator’s lead product, CPX-351 for the treatment of AML, has completed two randomized, controlled Phase 2 studies in over 250 patients with AML and has commenced a Phase 3 study in 300 patients with secondary AML in the fourth quarter of 2012. Celator’s pipeline includes a clinical stage product, CPX-1, for colorectal cancer and CPX-571 and CPX-8, both preclinical stage product candidates, potentially for solid tumors.
Celator was founded in 1999 by a team led by Dr. Lawrence Mayer (currently Celator’s President and Chief Scientific Officer) and Dr. Marcel Bally from the British Columbia Cancer Agency. Celator’s strategy evolved into developing drug combination products based on CombiPlex, Celator’s proprietary drug ratio technology platform.
Since the founding of Celator, $86.4 million has been invested in research and development with funds being used with the Company’s proprietary technologies, including CombiPlex, creating a pipeline of drugs and managing the clinical studies. Celator’s commercial success depends upon its ability, and the ability of any of its future collaborators, to develop, manufacture, market, and sell the product candidates. Numerous U.S. and foreign-issued patents and pending patent applications that are owned by third parties exist in the fields in which Celator is developing products. There is no guarantee that Celator will be able to market or sell any of its products.
Celator intends to use its cash and cash equivalents to fund its development activities, including clinical studies, manufacturing development (including capital expenditures), working capital and other general corporate purposes.
Celator has spent research and development funds on clinical studies, research collaborations and intellectual property costs. The three major studies are:
• | Study 204 - Randomized Phase 2 Study of CPX-351 in Newly Diagnosed AML Patients, Age 60-75 |
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• | Study 205 - Randomized Phase 2 Study of CPX-351 in AML in First Relapse Patients, Age 18-65 |
• | Study 301 - Randomized Phase 3 Study in Patients with sAML, Age 60-75 |
Study 204 was intended to be a direct test of whether delivery of a fixed, synergistic ratio of two drugs (i.e., CPX-351) provided increased clinical efficacy over conventional administration of the same agents (i.e., 7+3 regimen). In the overall population, patients treated with CPX-351 achieved relative improvements over the control arm. The first patient was enrolled in November 2008, and this study has been completed, and no further costs are expected to be incurred. In secondary AML patients, the response rate increased by 82% (57.5% vs. 31.6%), the 60-day mortality was decreased approximately 81% (6.1% vs. 31.6%), the median event free survival increased approximately 3.5 fold (4.5 months vs. 1.3 months) and the median overall survival increased approximately 2-fold (12.1 months vs. 6.1 months).
Study 205 was a randomized Phase 2 clinical study designed to be a direct test of whether CPX-351 provides increased clinical efficacy over salvage therapies in first relapse AML patients age 18-65. In the overall population, patients treated with CPX-351 achieved relative improvements over the control arm. The first patient was enrolled in March 2009, and this study has been completed, and no further costs are expected to be incurred. For patients in the unfavorable risk category (68% of the overall population), CPX-351 outperformed the control arm of salvage treatment with a 42.4% relative increase in response rate (39.3% vs. 27.6%), a 33.2% decrease in 60-day mortality (16.1% vs. 24.1%), a 57.1% relative increase in median overall survival (6.6 months vs. 4.2 months) and an approximately 3-fold higher 1-year survival rate (28.6% vs. 10.3%).
Study 301 has been undertaken to confirm the Study 204 clinical observations where CPX-351 provided the largest efficacy improvements in secondary AML patients and to provide the necessary data for product registration. Study 301 enrolled the first patient in December 2012. There will be significant costs associated with this study, including site enrollment, grants, patient monitoring, database maintenance, statistical monitoring, data analysis, salaries and insurance. The projected cost for this study is $35.0 million, and primary efficacy endpoint is anticipated in early 2016. The timeline and costs for this study have been based on Celator’s experience with Study 204; Celator has targeted sites in the U.S. and Canada for participation in this study. If this study is prolonged due to an insufficient number of study sites, a lack of patient enrollment or some other unforeseen circumstance, the costs will increase.
Total patient enrollment is expected to be completed by year-end 2014, with initial data (remission rate and some safety data) available by the second quarter of 2015. The final overall survival endpoint is expected to be available in the first quarter of 2016, with the New Drug Application (NDA) anticipated to be filed in the second half of 2016.
In connection with Celator’s strategy to ensure sufficient funding to finance the Phase 3 study of CPX-351 and because the product manufacturing is now being performed at a third party location, in September 2011 Celator closed the laboratory portion of its facility in Princeton. All the scientific equipment in Princeton was sold and six employees were terminated. The Princeton facility retained the office space it had occupied prior to the lab being closed, and continued to lease the office space on a month-to-month basis in order to manage operations including the clinical trials until June 2013, when the headquarters office relocated to Ewing, New Jersey.
During the period from October to December 2011, Celator also closed the laboratory portion of its facility in Vancouver and sold a portion of the scientific equipment at that site and nine employees were terminated. The Vancouver facility retained the office space it had occupied prior to the lab being closed, and leased this space on a month-to-month basis until March 1, 2012 when operations were moved to a smaller office. In February 2012, a portion of the Vancouver laboratory equipment was placed on consignment in California to be sold either through auction or on-line sales.
In June 2012, Celator entered into an agreement with the Leukemia and Lymphoma Society (“LLS”) pursuant to which the LLS is providing $5.0 million in funding from the LLS Therapy Acceleration Program (“TAP”) program for the Phase 3 study of CPX-351. The agreement provided for LLS to make an upfront payment of $2.0 million to Celator, which was received in July 2012, and further payments totaling an additional $3.0 million on the achievement of clinical milestones; however, the amount may be refundable by the Company in the event of a material breach by the Company under the agreement. The $2.0 million upfront payment has been recorded as deferred revenue and will be recognized over the estimated performance period of the research and development services to be provided under the agreement. As of September 30, 2013, $1.3 million was deferred. In November
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2012, a milestone payment of $500,000 was recognized for the first Institutional Review Board approval and a further milestone payment of $500,000 was earned for the first patient enrolled, which occurred in December 2012. In consideration of LLS’s funding, and transfer to the Company of any rights LLS may have to any project inventions developed during the term of the agreement, the Company must pay LLS a multiple on the LLS funding. (LLS funding is the $5 million in support of the Phase 3 study in addition to the approximately $4.1 million the Company received in support of the Phase 2 study during 2010 and 2011). Subject to exclusions under the agreement, the Company is obligated to pay LLS an amount equal to 50% of the cash payments the Company receives from out-licenses and transfers of rights to the product or other liquidity event, as defined in the agreement, until LLS has received an amount equal to 1.5 times the amount of funding the Company receives from LLS. The total amount payable by the Company to LLS will not exceed 3.55 times the amount of funding received from LLS, with the specific amount depending on when the payment(s) occur relative to the timing of the research program and product commercialization. The payments may take the form of cash payments or royalties (not to exceed 5% of net sales) but will not exceed the maximum amount referred to in the preceding sentence.
In June 2012, Celator entered into a Loan and Security Agreement with a bank (the “Bank Loan”). The terms of the Bank Loan allowed for Celator to draw up to $3.0 million until December 15, 2012. In June 2012, Celator borrowed an initial $1.0 million. In August 2012, the Company drew the remaining $2.0 million. The Bank Loan bears interest at a rate of 5.5%, and interest only is payable for the first six months until December 15, 2012 after which combined monthly payments of principal and interest are due for a 30-month period. During the six months ended June 30, 2013, Celator repaid the remaining outstanding principal balance of $3.0 million.
On April 29, 2013, the Company entered into a securities purchase agreement and subscription agreements with certain accredited investors for the issuance and sale in the final round of a private placement of 10,430,034 shares of common stock, which the Company sold at a price of $3.116 per share for aggregate gross proceeds of $32.5 million. Warrants to purchase 0.28 shares of common stock at $3.58 per share were issued for each share of common stock purchased. An additional 1,923,599 shares of common stock and 1,218,225 warrants to purchase shares of common stock were issued at the final closing to certain existing stockholders of the Company who participated in earlier closings of this financing. The net proceeds totaled $29.4 million for this financing and will support the late-stage clinical development of the Company’s lead investigational product, CPX-351 (cytarabine:daunorubicin) Liposome Injection.
The Company offered and sold these securities pursuant to Section 4(2) of the Securities Act and Regulation D under the Securities Act solely to persons who qualified as accredited investors, as that term is defined in Rule 501(a) of Regulation D, and pursuant to Regulation S under the Securities Act solely to persons who reside outside of the U.S.
Results of Operations
Three months ended September 30, 2013 compared to the three months ended September 30, 2012
Expenses
Research and Development: Research and development for three months ended September 30, 2013 increased due to the CPX-351 Phase 3 clinical trial which began recruiting patients in the fourth quarter of 2012. Celator charges research and development costs to operations as incurred.
Celator’s research and development expenses were $2,326,000 for the three months ended September 30, 2013 compared to $1,513,000 for the three months ended September 30, 2012 reflecting an increase of $813,000. The increase was primarily attributable to $379,000 increase in outsourced clinical trial and regulatory activities during the quarter related to the Phase 3 trial of CPX-351, $384,000 increase in compensation and stock option expense, $84,000 for a metabolism study for CPX-351, $85,000 increase in quality assurance audits and external services, $75,000 increase in stability and validation studies and $40,000 increase in clinical travel costs to sites. These increases were offset by reductions in manufacturing and drug and lipid costs of $227,000.
Leukemia & Lymphoma Society Funding: The LLS funding for the three months ended September 2013 was $136,000 as compared to $154,000 for the three months ended September 30, 2012. Amounts recognized during the quarters ended September 30, 2013 and 2012 represent amortization of a $2,000,000 upfront payment received during 2012 which was deferred and is being recognized over the estimated performance period of the research and development services to be provided under the agreement.
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General and Administrative: General and administrative expenses consist of salaries and related benefits, lease expense of the facilities, professional fees relating to legal, accounting, and tax services and other administrative costs.
General and administrative expenses were $1,434,000 for the three months ended September 30, 2013 compared to $946,000 for the three months ended September 30, 2012, reflecting an increase of $488,000. The increase was primarily attributable to $566,000 increase in compensation and stock option expenses, $81,000 for board of directors and scientific advisory board expenses and $47,000 of recruitment expenses. These increases were offset by reductions in professional fees of $197,000 and reduction in fees associated with registering to become a public reporting company of $40,000.
Gain on Disposal of Property and Equipment: The Company recorded a gain on disposal of property and equipment of $12,000 for the three months ended September 30, 2013 as compared to $31,000 loss for the three months ended September 30, 2012. The gain in 2013 and loss in 2012 arose from the sale of assets that were classified as held for sale.
Amortization and Depreciation: Amortization and depreciation expense was $51,000 for the three months ended September 30, 2013 and $81,000 for the three months ended September 30, 2012. The decrease in expense was due to certain property and equipment consigned and classified as assets held for sale in 2012 which were no longer depreciated in 2013.
Other Income and Expenses
Interest Expense: Interest expense was $3,794,000 for the three months ended September 30, 2012 related to the Company’s previously outstanding Convertible Notes.
Nine months ended September 30, 2013 compared to the nine months ended September 30, 2012
Expenses
Research and Development: Research and development for nine months ended September 30, 2013 increased due to the CPX-351 Phase 3 clinical trial which began recruiting patients in the fourth quarter of 2012. Celator charges research and development costs to operations as incurred.
Celator’s research and development expenses were $5,996,000 for the nine months ended September 30, 2013 compared to $3,296,000 for the nine months ended September 30, 2012 reflecting an increase of $2,700,000. The increase was primarily attributable to $1,656,000 increased in outsourced clinical trial and regulatory activities related to the Phase 3 trial of CPX-351, $100,000 increase in travel costs associated with clinical trials, $700,000 increase in compensation and stock option expenses, $102,000 for a metabolism study for CPX-351, $120,000 increase in drug storage and shipping costs to sites, $78,000 increase in quality assurance audits and external services and $97,000 increase for stability and validation studies. These increases were offset by reductions in manufacturing and drug and lipid costs of $218,000.
Leukemia & Lymphoma Society Funding: The LLS funding for the nine months ended September 30, 2013 was $425,000 compared to $289,000 for the nine months ended September 30, 2012. Amounts recognized during the nine months ended September 30, 2013 and 2012 represent amortization of a $2,000,000 upfront payment received during 2012, which was deferred and is being recognized over the estimated performance period of the research and development services to be provided under the agreement.
General and Administrative: General and administrative expenses consist of salaries and related benefits, lease expense of the facilities, professional fees relating to legal, accounting, and tax services and other administrative costs.
General and administrative expenses were $3,922,000 for the nine months ended September 30, 2013 compared to $2,845,000 for the nine months ended September 30, 2012, reflecting an increase of $1,077,000. The increase was primarily attributable to $858,000 increase in compensation expenses including severances related to finance staff reductions in Vancouver, British Columbia, Canada, new finance staff in New Jersey, executive compensation and stock option charges, $128,000 increase in board of directors and scientific advisory board expenses, $87,000 increase in directors and officers insurance, $83,000 recruitment expenses and $206,000 increase in professional fees.
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These increases were offset by a reduction of $312,000 in diligence related costs with registering to become a public reporting company incurred during the nine months ended September 30, 2012.
Loss on Disposal of Property and Equipment: The Company recorded a loss on disposal of property and equipment of $127,000 for nine months ended September 30, 2013 as compared to $50,000 for the nine months ended September 30, 2012.
Amortization and Depreciation: Amortization and depreciation expense was $148,000 for the nine months ended September 30, 2013 and $253,000 for the nine months ended September 30, 2012. The decrease in expense was due to certain property and equipment consigned and classified as assets held for sale which were no longer depreciated in 2013.
Other Income and Expenses
Non-cash derivative instrument charge:Non-cash derivative instrument charge was $7,473,000 for the nine months ended September 30, 2013. The charge resulted from the obligation to issue additional shares of common stock and warrants by Celator, at the April 29, 2013 closing, to certain existing stockholders who participated in early closings of this financing.
Interest Expense: Interest expense was $147,000 and $4,221,000 for the nine months ended September 30, 2013 and September 30, 2012 respectively. Interest expense of $72,000 for the nine months ended September 30, 2013 related to interest on a bank loan and $75,000 related to non-cash financing costs. Interest expense of $27,000 for the nine months ended September 30, 2012 related to interest on a bank loan and $4,194,000 was non-cash related to the Company’s previously outstanding Convertible Notes.
Liquidity and Capital Resources
Overview
There is considerable time and cost associated with developing a potential drug or pharmaceutical product to the point of regulatory approval and commercialization. To date, the Company has funded its operations primarily through private placements of preferred stock and common stock, convertible debt and debt financings. However, we may pursue additional financing options, including entering into agreements with collaborative partners in order to provide milestone payments, license fees and equity investments. As of September 30, 2013, the Company had received net proceeds of approximately $140.1 million from the sale of equity securities, approximately $7.5 million from the issuance of convertible promissory notes, and approximately $10.4 million from bank debt. As of September 30, 2013, the Company had cash and cash equivalents of approximately $27.6 million. In April 2013, the Company raised $29.4 million of net proceeds from the final round of a private placement (See Note 8 to the Consolidated Financial Statements). We expect to continue to incur losses as we fund our research and development activities and commercial launch activities, and we do not expect material revenues for at least the next few years.
Even though we believe we currently have sufficient funds to meet our financial needs into the second half of 2015, our business strategy in the future may require us, or we may otherwise determine, to raise additional capital through licensing, debt or equity sales, other means or any combination of these options. The Company’s future capital requirements will depend on many factors, including those factors described in Item 1A. “Risk Factors” of the 2012 Form 10-K annual report as well as the Company’s ability to execute on its business and strategic plans as currently conceived.
Cash Flows
Net cash used in operating activities was $8,398,000 for the nine months ended September 30, 2013. The nine months ended September 30, 2013 amount reflected the Company’s net loss of $17,402,000, offset by $8,122,000 in net non-cash charges including amortization and depreciation of $148,000, stock-based compensation expense of $322,000, loss on disposal of property and equipment of $127,000, non-cash charge relating to a derivative instrument of $7,473,000 and non-cash interest expense of $75,000 related to the deferred financing costs amortization for bank loan. In addition, the Company generated $860,000 of operating cash as a result of changes in certain of its operating assets and liabilities during the nine months ended September 30, 2013. The changes in operating assets and liabilities were decreases in other receivables of $1,991,000, increases in accrued liabilities of $208,000 and deferred rent liability of $23,000 offset by increases in prepaid expenses and deposits $134,000,
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restricted cash of $250,000, and other current assets of $530,000 and decreases in accounts payable of $22,000 and deferred revenue of $425,000. Net cash used in operating activities was $2,706,000 for the nine months ended September 30, 2012. The nine months ended September 30, 2012 amount reflected the Company’s net loss of $10,367,000, offset by $4,499,000 in net non-cash charges including amortization and depreciation of $253,000, stock-based compensation expense of $2,000, loss on disposal of property and equipment of $50,000 and non-cash financing costs of $4,194,000 related to the Company’s previously outstanding Convertible Notes. In addition, the Company generated $3,162,000 of operating cash as a result of changes in certain of its operating assets and liabilities during the nine months ended September 30, 2012. The changes in operating assets and liabilities were decreases in other receivables of $1,114,000, and increases in accounts payable of $322,000, accrued liabilities of $38,000, and deferred revenue of $1,846,000 offset by increases in prepaid expenses and deposits of $102,000, other assets of $54,000, and restricted cash of $2,000.
Cash used in investing activities was $30,000 for the nine months ended September 30, 2013, reflecting $82,000 of property and equipment expenditures and $52,000 of proceeds from the sale of property and equipment. Cash provided by investing activities for the nine months ended September 30, 2012 was $13,000, reflecting $18,000 of property and equipment expenditures, and $31,000 of proceeds from sale property and equipment.
Cash provided by financing activities for the nine months ended September 30, 2013 was $26,420,000. The cash inflow was from the net proceeds of $29,420,000 from the April 2013 final round of a private placement offset by $3,000,000 for the repayment of bank debt. Cash provided by financing activities for the nine months ended September 30, 2012 was $10,863,000. The cash inflow was from the proceeds from issuance of common stock of $5,439,000 and the issuance of debt of $5,424,000.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements, other than operating leases, that have or are reasonably likely to have a current or future material effect on our financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources. We do not have any interest in special purpose entities, structured finance entities or other variable interest entities.
Critical Accounting Policies
The Company’s significant accounting policies, which include management’s best estimates and judgments, are included in Note 2 to the consolidated financial statements for the year ended December 31, 2012 included in Celator Pharmaceuticals Inc.’s Form 10-K filed. There have been no significant changes in the Company’s critical accounting policies since December 31, 2012.
New Accounting Pronouncements
In March 2013, the Financial Accounting Standards Board (“FASB”) issued an amendment to the accounting guidance on foreign currency matters in order to clarify the guidance for the release of cumulative translation adjustment. The guidance is effective for interim and annual periods beginning on or after December 15, 2013. The Company does not expect the adoption of this guidance will have a material impact on its consolidated financial statements.
Item 3. | Quantitative and Qualitative Disclosures about Market Risk |
We invest excess cash in investment grade, interest-bearing securities and at September 30, 2013, had approximately $26.1 million invested in money market instruments and certificates of deposit. Such investments are subject to interest rate and credit risk and are not fully insured by the federal government. We believe our policy of investing in highly rated securities, whose liquidities are, at September 30, 2013, all less than 90 days minimizes such risks. In addition, while a hypothetical one percent per annum decrease in market interest rates would have decreased our interest income for the period, it would not have resulted in a loss of the principal and the decline in interest income would have been immaterial to us.
The majority of our business is conducted in U.S. dollars. However, we do conduct certain transactions in other currencies, including Canadian dollars. Historically, fluctuations in foreign currency exchange rates have not materially affected our results of operations, and during the nine months periods ended September 30, 2013 and 2012, our results of operations were not materially affected by fluctuations in foreign currency exchange rates.
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Item 4. | Controls and Procedures |
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of the Chief Executive Officer and Chief Financial Officer evaluated the effectiveness of our disclosure controls and procedures, as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended, as of the end of the period covered by this report. Based upon that evaluation, management identified a material weakness with respect to the recording of an obligation to issue additional shares of common stock and warrants as a derivative liability. The design of the Company’s procedures for the evaluation of complex accounting transactions and analysis of significant contracts, including the timely involvement of legal counsel was not effective and a material error occurred in the financial statements for the quarter ended March 31, 2013.
Remediation
Management has initiated steps to remediate the material weakness, including implementing a more formal review of complex accounting transactions and instituting procedures to involve external legal counsel on a timely basis to review significant contracts to ensure that the accounting transactions are reported timely and in accordance with the key terms of the contracts and U.S. generally accepted accounting principles.
Based on the Company’s evaluation and the remediation of the material weakness, as described above, the Chief Executive Officer and Chief Financial Officer have concluded that the Company’s disclosure controls and procedures were not effective as of September 30, 2013.
Change in Internal Control Over Financial Reporting
No change in the Company’s internal control over financial reporting occurred during the most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the internal control over financial reporting.
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Part II. Other Information
Item 1. | Legal Proceedings |
There are no material pending legal proceedings.
Item 1A. | Risk Factors |
Except for the historical information in this report, the matters contained in this report include forward-looking statements that involve risks and uncertainties. Our operating results and financial condition have varied in the past and may in the future vary significantly depending on a number of factors. These factors, among others, could cause actual results to differ materially from those contained in forward-looking statements made in this report and presented elsewhere by management from time to time. Such factors may have a material adverse effect upon our business, results of operations and financial condition.
You should consider carefully the risk factors, together with all of the other information included in our Annual Report on Form 10-K for the year ended December 31, 2012. Each of these risk factors could adversely affect our business, results of operations and financial condition, as well as adversely affect the value of an investment in our common stock. There have been no material changes to our risk factors as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2012.
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds |
There were no sales of equity securities during the three months ended September 30, 2013 other than as previously disclosed in the Company’s current report on Form 8-K filed with the SEC on May 3, 2013, which the Company incorporated by reference into this Form 10-Q quarterly report.
Item 6. | Exhibits |
Exhibits required by Item 601 of Regulation S-K are listed in the Exhibit Index hereto and include the following:
3.1 | Third Amended and Restated Certificate of Incorporation of the Company, as amended. (Incorporated by referenceto Exhibit 3.1 to the Company’s Form 8-K current report filed on May 24, 2013.) | |||
3.2 | Amended and Restated By-laws of the Company. (Incorporated by reference to Exhibit 3.2 to the Company’s Form 8-K current report filed on April 18, 2013.) | |||
4.1 | Form of Warrant. (Incorporated by reference to Exhibit 4.1 to the Company’s Form 8-K current report filed on May 3, 2013.) | |||
31.1 | Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or 15a-14(a) under the Exchange Act. | |||
31.2 | Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or 15a-14(a) under the Exchange Act. | |||
32.1 | Certification Pursuant to 18 U.S.C. Section 1350 of principal executive officer and principal financial officer. | |||
101.1 | The following materials from Celator Pharmaceuticals Inc.’s quarterly report on Form 10-Q for the quarter ended September 30, 2013, formatted in XBRL (eXtensible Business Reporting Language): (i) Consolidated Balance Sheets at September 30, 2013 and December 31, 2012, (ii) Consolidated Statement of Loss and Comprehensive Loss for the three and nine months ended September 30, 2013 and September 30, 2012, (iii) Consolidated Statements of Stockholders’ Equity for the period November 18, 1999 (inception) to September 30, 2013, (iv) Consolidated Statements of Cash Flows for the nine months ended September 30, 2013 and September 30, 2012, (v) Notes to Consolidated Financial Statements. |
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
CELATOR PHARMACEUTICALS, INC.
Signature | Title | Date | ||
/s/ Scott T. Jackson Scott T. Jackson | Chief Executive Officer and a Director (principal executive officer) | November 12, 2013 | ||
/s/ Fred M. Powell Fred M. Powell | Vice President and Chief Financial Officer (principal financial and accounting officer) | November 12, 2013 |
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EXHIBIT INDEX
Exhibit No. | Description | |
31.1 | Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or 15a-14(a) under the Exchange Act. | |
31.2 | Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or 15a-14(a) under the Exchange Act. | |
32.1 | Certification Pursuant to 18 U.S.C. Section 1350 of principal executive officer and principal financial officer. | |
101.1 | The following materials from Celator Pharmaceuticals Inc.’s quarterly report on Form 10-Q for the quarter ended September 30, 2013, formatted in XBRL (eXtensible Business Reporting Language): (i) Consolidated Balance Sheets at September 30, 2013 and December 31, 2012, (ii) Consolidated Statement of Loss and Comprehensive Loss for the three and nine months ended September 30, 2013 and September 30, 2012, (iii) Consolidated Statements of Stockholders’ Equity for the period November 18, 1999 (inception) to September 30, 2013, (iv) Consolidated Statements of Cash Flows for the nine months ended September 30, 2013 and September 30, 2012, (v) Notes to Consolidated Financial Statements. |