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 Quarterly Period Ended March 31, 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.) |
| |
303B College Road East Princeton, New Jersey | | 08540 |
(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 May 14, 2013 was 26,026,793.
CELATOR PHARMACEUTICALS, INC.
TABLE OF CONTENTS
| | | | | | |
| | | | Page | |
Part I. | | FINANCIAL INFORMATION | | | | |
| | |
Item 1. | | Financial Statements (Unaudited) | | | 1 | |
| | Consolidated Balance Sheets as March 31, 2013 and December 31, 2012 | | | 1 | |
| | Consolidated Statements of Loss and Comprehensive Loss for the three months ended March 31, 2013 and 2012 and for the period November 18, 1999 (inception) to March 31, 2013 | | | 2 | |
| | Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 2013 and for the period November 18, 1999 (inception) to March 31, 2013 | | | 3 | |
| | Consolidated Statements of Cash Flows for the three months ended March 31, 2013 and 2012 and for the period November 18, 1999 (inception) to March 31, 2013 | | | 4 | |
| | Notes to Consolidated Financial Statements | | | 5 | |
Item 2. | | Management’s Discussion and Analysis of Financial Condition and Results of Operations | | | 11 | |
Item 3. | | Quantitative and Qualitative Disclosures About Market Risk | | | 16 | |
Item 4. | | Controls and Procedures | | | 16 | |
| | |
Part II. | | OTHER INFORMATION | | | | |
| | |
Item 1. | | Legal Proceedings | | | 16 | |
Item 1A. | | Risk Factors | | | 16 | |
Item 2. | | Unregistered Sales of Equity Securities and Use of Proceeds | | | 17 | |
Item 6. | | Exhibits | | | 17 | |
Signature | | | 18 | |
Exhibits | | | 19 | |
Part I. Financial Information
Item 1. Financial Statements
Celator Pharmaceuticals, Inc. and Subsidiaries
(A development stage company)
Consolidated Balance Sheets
(Unaudited)
| | | | | | | | |
| | March 31, 2013 | | | December 31, 2012 | |
Assets | | | | | | | | |
Current assets: | | | | | | | | |
Cash and cash equivalents | | $ | 8,110,389 | | | $ | 9,648,008 | |
Restricted cash | | | 339,377 | | | | 40,205 | |
Other receivables | | | 115,552 | | | | 2,000,357 | |
Prepaid expenses and deposits | | | 99,979 | | | | 148,275 | |
Assets held for sale | | | 207,566 | | | | 251,269 | |
Other current assets | | | 440,000 | | | | — | |
| | | | | | | | |
Total current assets | | | 9,312,863 | | | | 12,088,114 | |
Property and equipment, net | | | 1,197,437 | | | | 1,245,025 | |
Other assets | | | 161,102 | | | | 105,805 | |
| | | | | | | | |
Total assets | | $ | 10,671,402 | | | $ | 13,438,944 | |
| | | | | | | | |
Liabilities | | | | | | | | |
Current liabilities: | | | | | | | | |
Accounts payable | | $ | 597,169 | | | $ | 699,858 | |
Accrued liabilities | | | 1,937,866 | | | | 1,194,998 | |
Current portion of deferred revenue | | | 615,384 | | | | 615,384 | |
Current portion of loans | | | 1,200,000 | | | | 1,200,000 | |
| | | | | | | | |
Total current liabilities | | | 4,350,419 | | | | 3,710,240 | |
| | |
Deferred revenue | | | 923,078 | | | | 1,076,924 | |
Loans payable | | | 1,500,000 | | | | 1,800,000 | |
| | | | | | | | |
Total liabilities | | | 6,773,497 | | | | 6,587,164 | |
| | | | | | | | |
Stockholders’ Equity | | | | | | | | |
Common stock | | | | | | | | |
Authorized 255,000,000 shares, par value $0.001 Issued and outstanding 13,673,160 shares as of March 31, 2013 and December 31, 2012 | | | 13,673 | | | | 13,673 | |
Warrants | | | 1,083,193 | | | | 1,083,193 | |
Additional paid-in capital | | | 118,513,671 | | | | 118,509,395 | |
Accumulated other comprehensive loss | | | (1,133,266 | ) | | | (1,133,266 | ) |
Deficit accumulated during the development stage | | | (114,579,366 | ) | | | (111,621,215 | ) |
| | | | | | | | |
Total Stockholders’ Equity | | | 3,897,905 | | | | 6,851,780 | |
| | | | | | | | |
Total Liabilities and Stockholders’ Equity | | $ | 10,671,402 | | | $ | 13,438,944 | |
| | | | | | | | |
See accompanying notes to consolidated financial statements.
1
Celator Pharmaceuticals, Inc. and Subsidiaries
(A development stage company)
Consolidated Statement of Loss and Comprehensive Loss
(Unaudited)
| | | | | | | | | | | | |
| | Three months ended | | | November 18, 1999 | |
| | March 31 | | | (inception) to | |
| | 2013 | | | 2012 | | | March 31, 2013 | |
Expenses | | | | | | | | | | | | |
Research and development | | $ | 1,651,409 | | | $ | 920,475 | | | $ | 82,069,074 | |
Leukemia & Lymphoma Society funding | | | (153,846 | ) | | | (135,000 | ) | | | (5,610,268 | ) |
Research collaboration income | | | — | | | | — | | | | (2,240,720 | ) |
General and administrative | | | 1,348,999 | | | | 778,350 | | | | 38,549,719 | |
Loss on disposal of property and equipment | | | 13,727 | | | | 13,872 | | | | 785,813 | |
Amortization and depreciation | | | 47,588 | | | | 85,965 | | | | 4,721,818 | |
| | | | | | | | | | | | |
Operating loss | | | (2,907,877 | ) | | | (1,663,662 | ) | | | (118,275,436 | ) |
| | | | | | | | | | | | |
Other income (expenses) | | | | | | | | | | | | |
Foreign exchange (loss) gain | | | (3,049 | ) | | | 83 | | | | 540,199 | |
Interest and miscellaneous income | | | 429 | | | | 879 | | | | 2,762,398 | |
Gain on settlement in exchange of preferred stock | | | — | | | | — | | | | 1,562,689 | |
Interest expense | | | (47,654 | ) | | | (366,917 | ) | | | (5,936,946 | ) |
| | | | | | | | | | | | |
Loss before income taxes | | | (2,958,151 | ) | | | (2,029,617 | ) | | | (119,347,096 | ) |
| | | | | | | | | | | | |
Income tax benefit | | | — | | | | — | | | | 6,243,583 | |
| | | | | | | | | | | | |
Net loss incurred in the development stage | | | (2,958,151 | ) | | | (2,029,617 | ) | | | (113,103,513 | ) |
Other comprehensive loss attributable to foreign exchange translation | | | — | | | | — | | | | (1,133,266 | ) |
| | | | | | | | | | | | |
Comprehensive loss | | | (2,958,151 | ) | | | (2,029,617 | ) | | | (114,236,779 | ) |
Accretion on preferred stock | | | — | | | | — | | | | (1,475,853 | ) |
| | | | | | | | | | | | |
Total comprehensive loss attributable to common stockholders | | $ | (2,958,151 | ) | | $ | (2,029,617 | ) | | $ | (115,712,632 | ) |
| | | | | | | | | | | | |
| | | |
Net loss incurred in the development stage | |
| (2,958,151
| )
| | | (2,029,617 | ) | | | (113,103,513 | ) |
Accretion on preferred stock | | | — | | | | — | | | | (1,475,853 | ) |
| | | | | | | | | | | | |
Net loss attributable to common stockholders | | $ | (2,958,151 | ) | | $ | (2,029,617 | ) | | $ | (114,579,366 | ) |
| | | | | | | | | | | | |
Net loss per share | | | | | | | | | | | | |
Basic and diluted | | $ | (0.22 | ) | | $ | (0.18 | ) | | | | |
| | | | | | | | | | | | |
Weighted average of common shares outstanding | | | | | | | | | | | | |
Basic and diluted | | | 13,673,160 | | | | 11,230,667 | | | | | |
| | | | | | | | | | | | |
See accompanying notes to consolidated financial statements.
2
Celator Pharmaceuticals, Inc. and Subsidiaries
(A development stage company)
Consolidated Statements of Stockholders’ Equity
From November 18, 1999 (inception) to March 31, 2013
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | WARRANTS AMOUNT | | | ADDITIONAL PAID-IN CAPITAL | | | ACCUMULATED OTHER COMPREHENSIVE LOSS | | | DEFICIT ACCUMULATED DURING THE DEVELOPMENT STAGE | | | STOCKHOLDERS’ EQUITY | |
| | | | | | | | | | | | | | | | | |
| | COMMON STOCK | | | RESTRICTED STOCK | | | | | | |
| | NUMBER | | | AMOUNT | | | NUMBER | | | AMOUNT | | | | | | |
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 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Balance at December 31, 2007 | | | 5,370,810 | | | | 5,371 | | | | — | | | | — | | | | 425,000 | | | | 60,883,367 | | | | (1,133,266 | ) | | | (51,686,350 | ) | | | 8,494,122 | |
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 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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 cost | | | 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 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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 | | | — | | | | — | | | | — | | | | — | | | | — | | | | 4,276 | | | | — | | | | — | | | | 4,276 | |
Net loss for the period | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | (2,958,151 | ) | | | (2,958,151 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Balance at March 31, 2013 | | | 13,673,160 | | | $ | 13,673 | | | | — | | | $ | — | | | $ | 1,083,193 | | | $ | 118,513,671 | | | $ | (1,133,266 | ) | | $ | (114,579,366 | ) | | $ | 3,897,905 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
See accompanying notes to consolidated financial statements.
3
Celator Pharmaceuticals, Inc. and Subsidiaries
(A development stage company)
Consolidated Statements of Cash Flows
(Unaudited)
| | | | | | | | | | | | |
| | Three months ended | | | November 18, 1999 | |
| | March 31 | | | (inception) to | |
| | 2013 | | | 2012 | | | March 31, 2013 | |
Operating activities | | | | | | | | | | | | |
Net loss | | $ | (2,958,151 | ) | | $ | (2,029,617 | ) | | $ | (114,579,366 | ) |
Adjustments to reconcile net loss to net cash used in operating activities | | | | | | | | | | | — | |
Amortization and depreciation | | | 47,588 | | | | 85,965 | | | | 4,721,818 | |
Accretion on preferred stock | | | — | | | | — | | | | 1,475,853 | |
Non-cash stock-based compensation expense | | | 4,276 | | | | 802 | | | | 1,123,428 | |
Gain on settlement of preferred stock | | | — | | | | — | | | | (1,562,689 | ) |
Loss on disposal of property and equipment | | | 13,727 | | | | 13,872 | | | | 785,813 | |
Non-cash financing costs | | | 7,733 | | | | 366,917 | | | | 4,704,159 | |
Changes in operating assets and liabilities | | | | | | | | | | | | |
Other receivables | | | 1,884,109 | | | | 953,258 | | | | (116,248 | ) |
Prepaid expenses and deposits | | | 47,997 | | | | (45,740 | ) | | | (100,278 | ) |
Other current assets | | | (440,000 | ) | | | — | | | | (440,000 | ) |
Restricted cash | | | (300,001 | ) | | | — | | | | (300,001 | ) |
Other assets | | | (63,109 | ) | | | — | | | | (168,914 | ) |
Accounts payable | | | (101,786 | ) | | | (312,858 | ) | | | 598,075 | |
Accrued liabilities | | | 747,494 | | | | 30,292 | | | | 1,951,424 | |
Deferred revenue | | | (153,846 | ) | | | — | | | | 1,538,462 | |
| | | | | | | | | | | | |
Cash used in operating activities | | | (1,263,969 | ) | | | (937,109 | ) | | | (100,368,464 | ) |
| | | | | | | | | | | | |
Investing activities | | | | | | | | | | | | |
Purchase of property and equipment | | | — | | | | (14,955 | ) | | | (7,337,998 | ) |
Proceeds on disposals of property and equipment | | | 29,976 | | | | 5,014 | | | | 425,364 | |
| | | | | | | | | | | | |
Cash provided by (used in) investing activities | | | 29,976 | | | | (9,941 | ) | | | (6,912,634 | ) |
| | | | | | | | | | | | |
Financing activities | | | | | | | | | | | | |
Proceeds from issuance of common stock and on options exercised | | | — | | | | 240 | | | | 8,515,281 | |
Proceeds from issuance of warrants and warrant derivatives | | | — | | | | — | | | | 500 | |
Proceeds from issuance of preferred stock | | | — | | | | — | | | | 102,157,702 | |
Payment of share issuance costs | | | — | | | | — | | | | (1,891,734 | ) |
Proceeds from loans payable | | | — | | | | 77,116 | | | | 17,898,295 | |
Repayments of capital lease obligation | | | — | | | | — | | | | (163,242 | ) |
Repayments of loans payable | | | (300,000 | ) | | | — | | | | (10,035,054 | ) |
| | | | | | | | | | | | |
Cash (used in) provided by financing activities | | | (300,000 | ) | | | 77,356 | | | | 116,481,748 | |
| | | | | | | | | | | | |
Effect of foreign exchange rate changes | | | (3,626 | ) | | | (1,576 | ) | | | (1,090,261 | ) |
| | | | | | | | | | | | |
Net change in cash | | | (1,537,619 | ) | | | (871,270 | ) | | | 8,110,389 | |
Cash and cash equivalents, beginning of period | | | 9,648,008 | | | | 3,226,778 | | | | — | |
| | | | | | | | | | | | |
Cash and cash equivalents, endof period | | $ | 8,110,389 | | | $ | 2,355,508 | | | $ | 8,110,389 | |
| | | | | | | | | | | | |
Supplemental disclosure of cash flow information | | | | | | | | | | | | |
Interest paid | | | 38,164 | | | | — | | | | 1,081,980 | |
Income taxes paid | | | — | | | | — | | | | 172,451 | |
Property and equipment purchased under capital lease | | | — | | | | — | | | | 449,744 | |
Common stock issued on conversion of debt | | | — | | | | — | | | | 6,842,144 | |
Preferred stock issued on conversion of debt | | | — | | | | — | | | | 5,337,417 | |
Capital expenditure incurred but not paid | | | — | | | | — | | | | — | |
See accompanying notes to consolidated financial statements
4
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 March 31, 2013, the Company had an accumulated deficit of $114,579,366. 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. In April 2013, the Company raised $29.6 million of net proceeds from a private placement (See Note 11).
The Company is subject to those risks associated with any specialty 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 generally accepted accounting principles (“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 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.
5
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 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) | |
March 31, 2013 | | | | | | | | | | | | | | | | |
Assets: | | | | | | | | | | | | | | | | |
Money Market Fund | | $ | 7,213,484 | | | $ | 7,213,484 | | | $ | — | | | $ | — | |
| | | | | | | | | | | | | | | | |
December 31, 2012 | | | | | | | | | | | | | | | | |
Assets: | | | | | | | | | | | | | | | | |
Money Market Fund | | $ | 9,107,500 | | | $ | 9,107,500 | | | $ | — | | | $ | — | |
| | | | | | | | | | | | | | | | |
Other receivables as of March 31, 2013 and December 31, 2012, consist of the following:
| | | | | | | | |
| | March 31, 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 | | | | 95,910 | |
Receivables related to the Leukemia & Lymphoma Society funding | | | — | | | | 500,000 | |
Other receivables | | | 19,642 | | | | 40,888 | |
| | | | | | | | |
| | $ | 115,552 | | | $ | 2,000,357 | |
| | | | | | | | |
Other current assets as of March 31, 2013 and December 31, 2012 consist of the following:
| | | | | | | | |
| | March 31, 2013 | | | December 31, 2012 | |
Clinical trial materials | | $ | 440,000 | | | $ | — | |
| | | | | | | | |
6
Property and equipment as of March 31, 2013 and December 31, 2012 including assets held under capital lease, consists of the following:
| | | | | | | | |
| | March 31, 2013 | | | December 31, 2012 | |
Computer and equipment | | $ | 103,858 | | | $ | 103,858 | |
Furniture and office equipment | | | 145,499 | | | | 145,499 | |
Laboratory equipment | | | 1,779,188 | | | | 1,779,188 | |
Capital lease equipment | | | 155,520 | | | | 155,520 | |
Leaseholds | | | 73,060 | | | | 73,060 | |
| | | | | | | | |
| | | 2,257,125 | | | | 2,257,125 | |
Less: Accumulated depreciation | | | (1,059,688 | ) | | | (1,012,100 | ) |
| | | | | | | | |
| | $ | 1,197,437 | | | $ | 1,245,025 | |
| | | | | | | | |
During the three months ended March 31, 2013 and March 31, 2012, depreciation and amortization expense was $47,588 and $85,965 respectively.
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 March 31, 2013 and December 31, 2012, the net book values of the remaining consigned equipment were $207,566 and $251,269, respectively, and consisted solely of scientific equipment which is presented as assets held for sale on the consolidated balance sheet.
During three months ended March 31, 2013 assets held for sale with a net book value of $43,703 were sold for proceeds of $29,976 resulting in a loss on disposal of $13,727.
Accrued liabilities as of March 31, 2013 and December 31, 2012:
| | | | | | | | |
| | March 31, 2013 | | | December 31, 2012 | |
Accrued bonuses | | $ | 477,350 | | | $ | 458,177 | |
Accrued salaries and vacation | | | 446,221 | | | | 198,817 | |
Accrued professional fees | | | 120,819 | | | | 265,802 | |
Accrued clinical trial expenses | | | 395,017 | | | | 188,057 | |
Accrued drug manufacturing expenses | | | 467,283 | | | | — | |
Accrued trade payables other | | | 31,176 | | | | 84,145 | |
| | | | | | | | |
| | $ | 1,937,866 | | | $ | 1,194,998 | |
| | | | | | | | |
7
8. | Stock Based Compensation |
There were no options issued during the three months ended March 31, 2013.
The stock-based compensation expense for the three months ended March 31, 2013 and March 2012 was $4,276 and $802, respectively.
The Company amortizes the grant-date fair value of the stock options on a straight-line basis over the applicable requisite service periods of the awards, which is generally the vesting period. At March 31, 2013, the total compensation cost related to non-vested awards not yet recognized and weighted average period over which it will be recognized was $2,518 and 1.0 years, respectively.
9. | 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 | |
| | March 31, 2013 | | | December 31, 2012 | |
United States | | $ | 8,854,343 | | | $ | 11,578,590 | |
Canada | | | 710,802 | | | | 717,250 | |
Germany | | | 1,106,257 | | | | 1,143,104 | |
| | | | | | | | |
Total Assets | | $ | 10,671,402 | | | $ | 13,438,944 | |
| | | | | | | | |
| |
| | Net Loss | |
| | Three months ended | |
| | March 31 | |
| | 2013 | | | 2012 | |
United States | | $ | (2,023,838 | ) | | $ | (1,390,375 | ) |
Canada | | | (934,313 | ) | | | (639,242 | ) |
| | | | | | | | |
Total Net Loss | | $ | (2,958,151 | ) | | $ | (2,029,617 | ) |
| | | | | | | | |
10. | 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 is expected to commence in June 2013 with a term of sixty months. The Company’s lease commitment is $643,000.
8
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 $250,000 during the first year of the Agreement, which amount will be reduced by $50,000 per year on each of December 1, 2014, 2015 and 2016 and by $75,000 on December 1, 2017, which amounts are subject to adjustment to lower amounts upon completion of a qualified financing. As discussed in Note 11, the Company completed a private placement in April 2013 which qualifies as a qualified financing. The security deposit obligation will be reduced to $200,000 during the first year of 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 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.) 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.
9
11. | April 2013 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 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 corresponding warrants were issued at the final closing to certain existing stockholders of the Company who participated in earlier closings of this financing. Estimated net proceeds totaling$29.6 million have been raised in this financing and will support the late-stage clinical development of the Company’s lead investigational product, CPX-351 (cytarabine:daunorubicin) Liposome Injection.
10
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, 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, headquartered in Princeton, New Jersey, is a biopharmaceutical company developing 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 17 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 is has commenced a Phase 3 study in 300 patients with secondary AML in the fourth quarter of 2012. Celator’s pipeline includes CPX-1 for colorectal cancer and CPX-571 and CPX-8, both preclinical stage product candidates.
Celator was founded in 1999 by a team led by Dr. Lawrence Mayer (currently Celator’s President and Head of Research) 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, $82.1 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.
11
Celator intends to use future net proceeds 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 |
| • | | 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 |
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 leukemia clearance rate increased 41.3% relative to the 7+3 control arm (81.8% vs. 57.9%), the response rate increased by 82% (57.5% vs. 31.6%), the 60-day mortality was decreased approximately 5-fold (6.1% vs. 31.6%), the 1-year survival rate increased approximately 4-fold (42.4% vs. 10.5%) and the median overall survival time 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 59.7% relative increase in leukemia clearance (66.1% vs. 41.4%), a 42.4% relative increase in response rate (39.3% vs. 27.6%), a decrease in 60-day mortality (16.1% vs. 24.1%), a 57.1% relative increase in median OS (6.6 months vs. 4.2 months) and an approximately 3-fold higher 1-year survival rate (30.4% 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 is in the early stages, with the first patient enrolled 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 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. 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 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 third quarter 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 continues to lease the office space on a month-to-month basis in order to manage operations including the clinical trials.
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 March 2012, a portion of the Vancouver laboratory equipment was placed on consignment in California to be sold either through auction or on-line sales.
12
In June 2012, Celator entered into an agreement with LLS pursuant to which the Leukemia and Lymphoma Society (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 December 31, 2012, $1.7 million was deferred. In November 2012, a milestone payment of $500,000 was recognized for the first IRB 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 outlicenses 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.
13
Recent Developments
New lease agreements
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 March2013, the Company entered into an office lease agreement for office space in Ewing, New Jersey which is expected to commence in June2013 with a term of sixty months, estimated to be May 31, 2018. The Company’s lease commitment is $643,000.
April 2013 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 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 corresponding warrants were issued at the final closing to certain existing stockholders of the Company who participated in earlier closings of this financing. Estimated net proceeds totaling$29.6 million have been raised in this financing and will support the late-stage clinical development of the Company’s lead investigational product, CPX-351 (cytarabine:daunorubicin) Liposome Injection. The funding is expected to fully fund the Company’s currently enrolling Phase 3 clinical study as first-line therapy in 60-75 years of age patients with secondary AML.
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 March 31, 2013 compared to the three months ended March 31, 2012
Expenses
Research and Development: Research and development for three months ended March 31, 2013 have 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 $1,651,000 for the three months ended March 31, 2013 compared to $920,000 for the three months ended March 31, 2012 reflecting an increase of $731,000. The increase was primarily attributable to $503,000 due to increased clinical trial and regulatory activities during the quarter and $174,000 for severance related to staff reductions.
Leukemia & Lymphoma Society Funding: The LLS funding for the three months ended March 2013 was $154,000 compared to $135,000 for the three months ended March 31, 2012. Amounts recognized during the quarter ended March 31, 2013, 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.
14
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 $1,349,000 for the three months ended March 31, 2013 compared to $778,000 for the three months ended March 31, 2012, reflecting an increase of $571,000. The increase was primarily attributable to $257,000 for severances related to finance staff reductions in Vancouver, British Columbia, Canada, $222,000 for increased professional services fees related to the Company becoming a public reporting entity, $127,000 for the new finance staff in Princeton, New Jersey, which were primarily related to legal fees for consulting on corporate and public company matters, and $55,000 for increased directors and officers liability insurance.
Loss on Disposal of Property and Equipment: The Company recorded a loss on disposal of property and equipment of $13,000 for each of the three month periods ended March 31, 2013 and 2012, respectively.
Amortization and Depreciation: Amortization and depreciation expense was $48,000 for the three months ended March 31, 2013 and $86,000 for the three months ended March 31, 2012. The decrease in expense was due to certain property and equipment consigned and classified as assets held for sale in February 2012 which were no longer depreciated in 2012.
Other Income and Expenses
Interest Expense: Interest expense was $48,000 and $367,000 for the three months ended March 31, 2013 and March 31, 2012 respectively. Interest expense for the three months ended March 31, 2013 relates to interest on a bank loan. The interest expense during the three months ended March 31, 2012 was non-cash related to the Company’s previously outstanding Convertible Notes. In February 2012 an investor purchased $77,000 in Convertible Notes and was entitled to a four time repayment of principal in the amount of $308,000 which was a non-cash financing cost for the three months ended March 31, 2012.
Liquidity and Capital Resources
To date, the Company has funded its operations primarily through private placements of preferred stock and common stock, convertible debt and debt financings. As of March 31, 2013, the Company had received net proceeds of approximately $110.7 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 March 31, 2013, the Company had cash and cash equivalents of approximately $8.1 million. In April 2013, the Company raised $29.6 million of net proceeds from a private placement (See Note 11 to the Consolidated Financial Statements).
The Company’s principal liquidity requirements are primarily to meet its working capital needs, support ongoing business activities, clinical trial costs and capital expenditures.
Cash Flows
In April 2013, the Company raised $29.6 million of net proceeds from a private placement and this funding is expected to fully fund the Company’s Currently enrolling Phase 3 clinical study as first-line therapy in patients 60-75 years of age with secondary AML. 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.
15
Net cash used in operating activities was $1,264,000 and $937,000 for the three months ended March 31, 2013 and 2012 respectively. The three months ended March 31, 2013 amount reflected the Company’s net loss of $2,958,000, offset by $73,000 in net non-cash charges including non-cash interest expense of $8,000 related to the deferred financing costs amortization for bank loan, amortization and depreciation of $48,000 loss on disposal of property and equipment of $14,000 and stock-based compensation expense of $4,000. In addition, the Company generated $1,620,000 of operating cash as a result of changes in certain of its operating assets and liabilities during the three months ended March 31, 2013. The changes in operating assets and liabilities were decreases in other receivables of $1,884,000, prepaid expenses and deposits $48,000, and increases in accrued expenses of $747,000. Offsetting these changes were decreases in accounts payable of $102,000, deferred revenue of $154,000 and increases in restricted cash of $300,000, other current assets of $440,000 and other assets of $63,000.
Cash provided by investing activities was $30,000 for the three months ended March 31, 2013 for disposals of property and equipment. Cash used in financing activities was $300,000 for the three months ended March 31, 2013 for repayment of the bank loan.
Cash used in investing activities for the three months ended March 31, 2012 was $10,000, principally reflecting $15,000 of property and equipment expenditures, and $5,000 of proceeds from sale property and equipment. Cash provided by financing activities for the three months ended March 31, 2012 was $77,000. The cash inflow was from the proceeds on issuance of debt.
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 |
Interest Rate Risk
The Company had outstanding total debt at March 31, 2013 of $2.7 million. The debt bears interest at a variable annual rate equal to the greater of: (i) 1.5% above the Prime Rate then in effect; or (ii) 5.5%, and interest only was 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.
Item 4. | Controls and Procedures |
Management of the Company, with the participation of its Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures over financial reporting for the period covered by this Form 10–Q. Based on this assessment, the Company’s Chief Executive Officer and Chief Financial Officer have concluded that as of March 31, 2013, the Company’s disclosure controls and procedures are effective. In recording, processing, summarizing and reporting, on a timely basis, information the Company is required to disclose in the reports that the Company files or submits under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Company’s disclosure controls and procedures are also effective to ensure that information the Company discloses in the reports the Company files under the Exchange Act is accumulated and communicated to the Company’s management, including the Company’s chief executive officer and chief financial officer, to allow timely decisions regarding required disclosure.
There have been no changes in internal control over financial reporting for the period covered by this report that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
Part II. Other Information
There are no material pending legal proceedings.
The risk factors set forth in Item 1A of the Company’s Form 10-K annual report for the year ended December 31, 2012 are incorporated by reference in to this Item 1 of Part II of this Form 10-Q report.
16
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds |
There were no sales of equity securities during the three months ended March 31, 2013. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations” Recent Developments.
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. (Incorporated by reference to Exhibit 3.1 to the Company’s Form 10 registration statement filed on November 13, 2012.) |
| |
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.) |
| |
10.1 | | Office Lease between the Company and Princeton South Investors, LLC dated March 1, 2013. |
| |
10.2 | | Securities Purchase Agreement among the Company and the purchasers listed therein. (Incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K current report filed on May 3, 2013.) |
| |
10.3 | | Registrants Rights Agreement among the Company and the investors listed therein. (Incorporated by reference to Exhibit 10.2 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 financial statements from Celator Pharmaceuticals Inc.’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2013, formatted in XBRL (eXtensible Business Reporting Language): (i) the Consolidated Balance Sheets at March 31 2013 and December 31, 2012, (ii) the Statement of Loss and Comprehensive Loss for the three months ended March 31, 2013 and 2012, (iii) Statements of Shareholders’ Equity for the three months ended March 31, 2013 and 2012, (iv) the Consolidated Statements of Cash Flows for the three months ended March 31, 2013 and 2012, and (v) Notes to Consolidated Financial Statements. |
17
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) | | May 15, 2013 |
| | |
/s/ Fred M. Powell Fred M. Powell | | Vice President and Chief Financial Officer (principal financial and accounting officer) | | May 15, 2013 |
18
EXHIBIT INDEX
| | |
Exhibit No. | | Description |
| |
3.1 | | Third Amended and Restated Certificate of Incorporation of the Company. (Incorporated by reference to Exhibit 3.1 to the Company’s Form 10 registration statement filed on November 13, 2012.) |
| |
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.) |
| |
10.1 | | Office Lease between the Company and Princeton South Investors, LLC dated March 1, 2013. |
| |
10.2 | | Securities Purchase Agreement among the Company and the purchasers listed therein. (Incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K current report filed on May 3, 2013.) |
| |
10.3 | | Registrants Rights Agreement among the Company and the investors listed therein. (Incorporated by reference to Exhibit 10.2 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 financial statements from Celator Pharmaceuticals Inc.’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2013, formatted in XBRL (eXtensible Business Reporting Language): (i) the Consolidated Balance Sheets at March 31 2013 and December 31, 2012, (ii) the Statement of Loss and Comprehensive Loss for the three months ended March 31, 2013 and 2012, (iii) Statements of Shareholders’ Equity for the three months ended March 31, 2013 and 2012, (iv) the Consolidated Statements of Cash Flows for the three months ended March 31, 2013 and 2012, and (v) Notes to Consolidated Financial Statements. |
19