CytRx Corporation
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2007
OR
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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 0-15327
CYTRX CORPORATION
(Exact name of Registrant as specified in its charter)
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Delaware
(State or other jurisdiction
of incorporation or organization)
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58-1642740
(I.R.S. Employer Identification No.) |
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11726 San Vicente Blvd.
Suite 650
Los Angeles, CA
(Address of principal executive offices)
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90049
(Zip Code) |
(310) 826-5648
(Registrants 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 þ No o
Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer.
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o |
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12(b)-2 of the
Exchange Act).
Yes o No þ
Number of shares of CytRx Corporation Common Stock, $.001 par value, issued and outstanding as of
May 7, 2007: 86,813,178 , exclusive of treasury shares.
CYTRX CORPORATION
Form 10-Q
Table of Contents
2
Part I FINANCIAL INFORMATION
Item 1. Financial Statements
CYTRX CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
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March 31, |
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December 31, |
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2007 |
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2006 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
36,351,989 |
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$ |
30,381,393 |
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Accounts receivable |
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105,930 |
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105,930 |
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Prepaid expense and other current assets |
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778,835 |
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233,323 |
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Total current assets |
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37,236,754 |
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30,720,646 |
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Equipment and furnishings, net |
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206,246 |
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252,719 |
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Molecular library, net |
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261,081 |
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283,460 |
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Goodwill |
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183,780 |
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183,780 |
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Deposits and prepaid insurance expense |
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183,877 |
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195,835 |
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Total assets |
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$ |
38,071,738 |
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$ |
31,636,440 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
777,207 |
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$ |
955,156 |
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Accrued expenses and other current liabilities |
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3,139,251 |
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2,722,478 |
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Deferred revenue, current portion |
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5,779,337 |
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6,733,350 |
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Total current liabilities |
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9,695,795 |
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10,410,984 |
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Deferred revenue, non-current portion |
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15,582,137 |
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16,075,117 |
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Total liabilities |
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25,277,932 |
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26,486,101 |
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Stockholders equity: |
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Preferred Stock, $.01 par value, 5,000,000
shares authorized, including 5,000 shares of
Series A Junior Participating Preferred
Stock; no shares issued and outstanding |
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Common stock, $.001 par value, 125,000,000
shares authorized; 77,681,000 and 70,789,000
shares issued at March 31, 2007 and December 31,
2006, respectively |
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77,681 |
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70,789 |
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Additional paid-in capital |
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159,144,014 |
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146,961,657 |
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Treasury stock, at cost (633,816 shares held
at March 31, 2007 and December 31, 2006,
respectively) |
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(2,279,238 |
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(2,279,238 |
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Accumulated deficit |
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(144,148,651 |
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(139,602,869 |
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Total stockholders equity |
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12,793,806 |
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5,150,339 |
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Total liabilities and stockholders equity |
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$ |
38,071,738 |
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$ |
31,636,440 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
CYTRX CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
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Three Months Ended |
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March 31, |
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2007 |
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2006 |
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Revenue: |
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Service revenue |
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$ |
1,446,993 |
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$ |
60,830 |
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Grant revenue |
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116,070 |
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1,563,063 |
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60,830 |
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Expenses: |
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Research and development (includes $281,000 and $44,000 of
non-cash stock-based compensation given to consultants for
the three month periods ended March 31, 2007 and 2006,
respectively; as well as $37,000 and $83,000 of non-cash
employee stock option expense for the three month periods
ended March 31, 2007 and 2006, respectively) |
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4,008,374 |
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2,312,010 |
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General and administrative (includes $0 and $68,000 of
non-cash stock-based compensation given to consultants for
the three month periods ended March 31, 2007 and 2006,
respectively; as well as $112,000 and $262,000 of non-cash
employee stock option expense for the three month periods
ended March 31, 2007 and 2006, respectively) |
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2,485,085 |
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2,022,667 |
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6,493,459 |
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4,334,677 |
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Loss before other income |
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(4,930,396 |
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(4,273,847 |
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Other income: |
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Interest and dividend income |
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382,614 |
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107,490 |
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Minority interest in losses of subsidiary |
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2,000 |
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Net loss applicable to common shareholders before deemed dividend |
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(4,545,782 |
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(4,166,357 |
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Deemed dividend for anti-dilution adjustment made to outstanding
common stock warrants |
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(488,429 |
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Net loss applicable to common shareholders |
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$ |
(4,545,782 |
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$ |
(4,654,786 |
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Basic and diluted: |
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Loss per common share |
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$ |
(0.06 |
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$ |
(0.07 |
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Weighted average shares outstanding |
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73,273,746 |
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62,343,290 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
4
CYTRX CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
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Three Months Ended March 31, |
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2007 |
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2006 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(4,545,782 |
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$ |
(4,166,357 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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71,353 |
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58,931 |
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Minority interest in losses of subsidiary |
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(2,000 |
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Common stock, stock options and warrants issued for services |
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975,545 |
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112,003 |
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Expense related to employee stock options |
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148,812 |
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345,000 |
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Net change in operating assets and liabilities |
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(1,741,723 |
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(278,109 |
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Total adjustments |
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(548,013 |
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237,825 |
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Net cash used in operating activities |
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(5,093,795 |
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(3,928,532 |
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Cash flows from investing activities: |
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Purchases of property and equipment |
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(2,501 |
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(23,447 |
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Net cash used in investing activities |
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(2,501 |
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(23,447 |
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Cash flows from financing activities: |
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Proceeds from exercise of stock options and warrants |
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11,064,892 |
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334,225 |
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Net proceeds from issuances of common stock |
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12,404,394 |
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Net proceeds from issuances of common stock in subsidiary |
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2,000 |
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Net cash provided by financing activities |
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11,066,892 |
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12,738,619 |
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Net increase in cash and cash equivalents |
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5,970,596 |
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8,786,640 |
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Cash and cash equivalents at beginning of period |
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30,381,393 |
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8,299,390 |
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Cash and cash equivalents at end of period |
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$ |
36,351,989 |
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$ |
17,086,030 |
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Supplemental disclosure of cash flow information: |
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Cash received during the periods for interest received |
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$ |
382,614 |
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$ |
107,490 |
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Non-Cash Financing Activities:
In connection with the Companys adjustment to the terms of certain outstanding warrants on
March 2, 2006, the Company recorded a deemed dividend of approximately $488,000 in the three-month
period ended March 31, 2006. The deemed dividend was recorded as a charge to retained earning and
a corresponding credit to additional paid-in capital.
The accompanying notes are an integral part of these condensed consolidated financial statements.
5
CYTRX CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2007
(Unaudited)
1. Description of Company and Basis of Presentation
CytRx Corporation (CytRx or the Company) is a biopharmaceutical research and development
company engaged in developing human therapeutic products based primarily upon our small molecule
molecular chaperone co-induction technology. The Company recently completed a Phase IIa clinical
trial of its lead small molecule product candidate, arimoclomol, for the treatment of amyotrophic
lateral sclerosis, which is commonly known as ALS or Lou Gehrigs disease. Arimoclomol has received
Orphan Drug and Fast Track designation from the U.S. Food and Drug Administration, or FDA, and
orphan medicinal product status from the European Commission for the treatment of ALS. The Company
plans to initiate a Phase IIb trial of arimoclomol for this indication during the second half of
2007, subject to FDA clearance. Additionally, recent preclinical animal studies indicated that
arimoclomol accelerated the recovery of sensory and motor functions following a stroke, even when
administered up to 48 hours after the stroke. Based upon these positive indications, the Company is
considering a possible Phase II clinical trial of arimoclomol in stroke patients. The Company also
is pursuing clinical development of its other small molecule product candidates, as well as a novel
HIV DNA + protein vaccine exclusively licensed to the Company and developed by researchers at the
University of Massachusetts Medical School, or UMMS, and Advanced BioScience Laboratories with
funding from the National Institutes of Health.
The Company also is engaged in developing therapeutic products based upon ribonucleic acid
interference, or RNAi, which has the potential to effectively treat a broad array of diseases by
interfering with the expression of targeted disease-associated genes. In order to fully realize the
potential value of our RNAi technologies, in January 2007, the Company transferred to RXi
Pharmaceuticals Corporation, its majority-owned subsidiary, substantially all of its RNAi-related
technologies and assets in exchange for equity in RXi. These assets consisted primarily of the
Companys licenses from UMMS and the Carnegie Institution of Washington relating to fundamental
RNAi technologies, as well as research and other equipment situated at the Companys Worcester,
Massachusetts, laboratory. On April 30, 2007, the Company provided to RXi $15.0 million, net of
expenses of approximately $2.0 million reimbursed to it by RXi, in exchange for additional equity
in RXi, to satisfy certain initial funding requirements under its agreements with UMMS. RXi is
focused solely on developing and commercializing therapeutic products based upon RNAi technologies
for the treatment of human diseases, with an initial focus on neurodegenerative diseases, cancer,
type 2 diabetes and obesity. The Company has agreed to reduce its share of ownership of RXi to
less than a majority of the outstanding voting power as soon as reasonably practicable. In order
to reduce its ownership interest in RXi, the Company has announced its intention to issue a
dividend of a portion of its RXi shares to its stockholders. Any proposed dividend to its
stockholders of RXi shares would be subject to approval of the CytRx board of directors, SEC rules
and the requirements of the Delaware General Corporation Law.
To date, the Company has relied primarily upon selling equity securities and upon proceeds
received upon the exercise of options and warrants and, to a much lesser extent, upon payments from
its strategic partners and licensees, to generate funds needed to finance our business and
operations. At March 31, 2007, the Company had cash and cash equivalents of $36.4 million, and it
received $19.2 million from the sale of shares in its April 2007 financing transaction, net of
offering expenses of approximately $2.8 million and the $15.0 million of net proceeds that it
provided to RXi on April 30, 2007 to satisfy the initial funding requirements under its agreements
with UMMS. Management believes that the Company has adequate financial resources to support its
currently planned level of operations into the second half of 2009, which expectation is based in
part on projected expenditures for 2007 of $4.5 million for the Companys Phase IIb trial of
arimoclomol for ALS and related studies, $4.4 million for its other ongoing and planned preclinical
programs, including a possible Phase II clinical trial of arimoclomol in stroke patients, and $8.8
million for general and administrative expenses. Management estimates that RXi separately will
expend approximately $6.2 million on development activities for 2007 (including approximately
$400,000 in cash payments under agreements with UMMS, $3.2 million in other research and
development expenses and $2.6 million in general and administrative expenses). The Company will be
required to obtain additional funding in order to execute its long-term business plans, although it
does not currently have commitments from any third parties to provide it with capital. The Company
cannot assure that additional funding will be available on favorable terms, or at all. If the
Company fails to obtain additional funding when needed, it may not be able to execute its business
plans and its business may suffer, which would have a material adverse effect on its financial
position, results of operations and cash flows.
In August 2006, the Company received approximately $24.3 million in proceeds from the
privately-funded ALS Charitable Remainder Trust (ALSCRT) in exchange for the commitment to continue
research and development of arimoclomol and other
6
potential treatments for ALS and a one percent royalty in the worldwide sales of arimoclomol.
Under the arrangement, the Company retains the rights to any developments funded by the arrangement
and the proceeds of the transaction are non-refundable. Further, the ALS Charitable Remainder Trust
has no obligation to provide any further funding to the Company. Management has analyzed the
transaction and concluded that due to the research and development components of the transaction
that it is properly accounted for under SFAS No. 68, Research and Development Arrangements (SFAS
No. 68). Accordingly, the Company has recorded the value received under the arrangement as deferred
service revenue and will recognize service revenue using the proportional performance method of
revenue recognition, meaning that service revenue is recognized as a percentage of actual research
and development expense incurred for the research and development of arimoclomol or the development
of other ALS treatments.
The accompanying condensed consolidated financial statements at March 31, 2007 and for the
three-month periods ended March 31, 2007 and 2006 are unaudited, but include all adjustments,
consisting of normal recurring entries, which the Companys management believes to be necessary for
a fair presentation of the periods presented. Interim results are not necessarily indicative of
results for a full year. Balance sheet amounts as of December 31, 2006 have been derived from our
audited financial statements as of that date.
Certain reclassifications have been made to the
prior years condensed financial statements to conform to the current year presentation.
The financial statements included herein have been prepared by the Company pursuant to the
rules and regulations of the Securities and Exchange Commission (SEC). Certain information and
footnote disclosures normally included in financial statements prepared in accordance with
accounting principles generally accepted in the U.S. have been condensed or omitted pursuant to
such rules and regulations. The financial statements should be read in conjunction with the
Companys audited financial statements in its Form 10-K for the year ended December 31, 2006. The
Companys operating results will fluctuate for the foreseeable future. Therefore, period-to-period
comparisons should not be relied upon as predictive of the results in future periods.
2. Recent Accounting Pronouncements
On July 13, 2006, the Financial Accounting Standards Board (FASB) issued Interpretation No.
48, Accounting for Uncertainty in Income Taxes, an interpretation of FASB Statement No. 109 (FIN
No. 48), to create a single model to address accounting for uncertainty in tax positions. FIN No.
48 clarifies the accounting for income taxes by prescribing a minimum recognition threshold in
which a tax position be reached before financial statement recognition. FIN No. 48 also provides
guidance on derecognition, measurement, classification, interest and penalties, accounting in
interim periods, disclosure and transition. FIN No. 48 is effective for fiscal years beginning
after December 15, 2006. The Company adopted FIN No. 48 as of January 1, 2007, as required. The
adoption of FIN No. 48 did not have an impact on the Companys financial position and results of
operations.
On September 15, 2006, the FASB issued Statement of Financial Accounting Standards (SFAS)
No. 157, Fair Value Measurements (SFAS No. 157). SFAS No. 157 defines fair value, establishes a
framework for measuring fair value in accordance with generally accepted accounting principles, and
expands disclosures about fair value measurements. SFAS No. 157 does not expand the use of fair
value in any new circumstances. SFAS No. 157 is effective for fiscal years beginning after November
15, 2007, and interim periods within those fiscal years. The Company does not expect SFAS No. 157
will have a significant impact on the Companys consolidated financial statements.
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities (SFAS No. 159). SFAS No. 159 permits entities to choose to measure many
financial assets and financial liabilities at fair value. Unrealized gains and losses on items for
which the fair value option has been elected are reported in earnings. SFAS No. 159 is effective
for fiscal years beginning after November 15, 2007. The Company is currently assessing the impact
of SFAS No. 159 on the Companys consolidated financial statements.
3. Basic and Diluted Loss Per Common Share
Basic net loss per share is computed using the weighted-average number of common shares
outstanding during the period. Diluted net loss per share is computed using the weighted-average
number of common shares and dilutive potential common shares outstanding during the period.
Dilutive potential common shares primarily consist of employee stock options and warrants. Common
share equivalents which potentially could dilute basic earnings per share in the future, and which
were excluded from the computation of diluted loss per share, as the effect would be anti-dilutive,
totaled approximately 22.7 million and 29.0 million shares at March 31, 2007 and 2006,
respectively.
In connection with the Companys adjustment to the exercise terms of certain outstanding
warrants to purchase common stock on March 2, 2006, the Company recorded a deemed dividend of
approximately $488,000. This deemed dividend is reflected as an
7
adjustment to net loss for the first quarter of 2006 to arrive at net loss applicable to
common stockholders on the Condensed Consolidated Statement of Operations and for purposes of
calculating basic and diluted earnings per shares.
4. Stock Based Compensation
As of March 31, 2007, an aggregate of 10,000,000 shares of common stock were reserved for
issuance under the Companys 2000 Stock Option Incentive Plan, including approximately 6,381,000
shares subject to outstanding stock options and approximately 2,880,000 shares available for future
grant. Additionally, the Company has two other plans, the 1994 Stock Option Plan and the 1998 Long
Term Incentive Plan, which include approximately 1,700 and 93,000 shares, respectively, subject to
outstanding stock options. As the terms of our plans provide that no options may be issued after 10
years, no options are available under the 1994 Plan. Under the 1998 Long Term Incentive Plan,
approximately 30,000 shares are available for future grant. Options granted under these plans
generally vest and become exercisable as to 33% of the option grants on each anniversary of the
grant date until fully vested. The options will expire, unless previously exercised, not later than
ten years from the grant date.
Prior to January 1, 2006, the Company accounted for its stock based compensation plans under
the recognition and measurement provisions of Accounting Principles Board No. 25, Accounting for
Stock Issued to Employees (APB 25), and related interpretations for all awards granted to
employees. Under APB 25, when the exercise price of options granted to employees under these plans
equals the market price of the common stock on the date of grant, no compensation expense is
recorded. When the exercise price of options granted to employees under these plans is less than
the market price of the common stock on the date of grant, compensation expense is recognized over
the vesting period.
The Companys share-based employee compensation plans are described in Note 13 to our
financial statements contained in our Annual Report on Form 10-K filed for the year ended December
31, 2006. On January 1, 2006, the Company adopted SFAS 123(R), Accounting for Stock-based
Compensation (Revised 2004) (SFAS 123(R)), which requires the measurement and recognition of
compensation expense for all share-based payment awards made to employees, non-employee directors,
and consultants, including employee stock options. SFAS 123(R) supersedes the Companys previous
accounting under APB 25 and SFAS 123, Employee Stock-Based Compensation, for periods beginning in
fiscal 2006. In March 2005, the Securities and Exchange Commission issued SAB 107, Share-Based
Payment, relating to SFAS 123(R). The Company has applied the provisions of SAB 107 in its adoption
of SFAS 123(R).
The Company adopted SFAS 123(R) using the modified prospective transition method, which
requires the application of the accounting standard as of January 1, 2006, the first day of the
Companys fiscal year 2006. The Companys Statement of Operations as of and for the year ended
December 31, 2006 reflects the impact of SFAS 123(R). In accordance with the modified prospective
transition method, the Companys Statements of Operations for prior periods have not been restated
to reflect, and do not include, the impact of SFAS 123(R). Share-based compensation expense
recognized under SFAS 123(R) for the year ended December 31,
2006 was $1.3 million.
For stock options paid in consideration of services rendered by non-employees, the Company
recognizes compensation expense in accordance with the requirements of SFAS No. 123(R) and Emerging
Issues Task Force Issue No. 96-18, Accounting for Equity Instruments that are Issued to Other Than
Employees for Acquiring, or in Conjunction with Selling, Goods or Services. Under SFAS 123(R),
the compensation associated with stock options paid to non-employees is generally recognized in the
period during which services are rendered by such non-employees. Since its adoption of SFAS 123(R),
there have been no changes to the Companys equity plans or modifications of its outstanding
stock-based awards.
Non-employee option grants that do not vest immediately upon grant are recorded as an expense
over the vesting period of the underlying stock options, using the method prescribed by FASB
Interpretation 28. At the end of each financial reporting period prior to vesting, the value of
these options, as calculated using the Black Scholes option pricing model, will be re-measured
using the fair value of the Companys common stock and deferred compensation and the non-cash
compensation recognized during the period will be adjusted accordingly. Since the fair market value
of options granted to non-employees is subject to change in the future, the amount of the future
compensation expense is subject to adjustment until the stock options are fully vested. The Company
recognized approximately $976,000 and $112,000 of stock based compensation expense related to
non-employee stock options for the three-month periods ended March 31, 2007 and 2006, respectively.
Included in the amount recognized in 2007 is an adjustment of approximately $695,000
related to options granted to consultants in 2006.
During the first quarter of 2007 the Company did not issue any stock options; however had we
issued options during this period the following assumptions would have been used and are presented
for comparison purposes. The fair value of stock options at the date of grant was estimated using
the Black-Scholes option-pricing model, based on the following assumptions:
8
|
|
|
|
|
|
|
|
|
|
|
Three-Months Ended |
|
|
|
March 31, 2007 |
|
|
March 31, 2006 |
|
|
|
|
|
|
|
(Restated) |
|
Risk-free interest rate |
|
|
4.41% - 4.89 |
% |
|
|
4.27% - 4.83 |
% |
Expected volatility |
|
|
116.8 |
% |
|
|
117.3 |
% |
Expected lives (years) |
|
|
6 |
|
|
|
6 |
|
Expected dividend yield |
|
|
0.00 |
% |
|
|
0.00 |
% |
The Companys expected stock price volatility assumption is based upon the historical daily
volatility of its publicly traded stock. For option grants issued during the three-month periods
ended March 31, 2007 and 2006, the Company used a calculated volatility for each grant. The
expected life assumptions were based upon the simplified method provided for under SAB 107, which
averages the contractual term of the Companys options of ten years with the average vesting term
of three years for an average of six years. The dividend yield assumption of zero is based upon the
fact the Company has never paid cash dividends and presently has no intention of paying cash
dividends. The risk-free interest rate used for each grant is equal to the U.S. Treasury rates in
effect at the time of the grant for instruments with a similar expected life. Based on historical
experience, for the three-month periods ended March 31, 2007 and 2006, the Company has estimated an
annualized forfeiture rate of 15% for options granted to its employees and 3% for options granted
to senior management and directors. The Company will record additional expense if the actual
forfeitures are lower than estimated and will record a recovery of prior expense if the actual
forfeiture rates are higher than estimated. Under provisions of SFAS 123(R), the Company recorded
$149,000 and $345,000 of employee stock-based compensation for the three-month periods ended March
31, 2007 and 2006, respectively. No amounts relating to employee stock-based compensation have been
capitalized. As of March 31, 2007, there was $772,000 of unrecognized compensation cost related to
outstanding options that is expected to be recognized as a component of the Companys operating
expenses through 2009. Compensation costs will be adjusted for future changes in estimated
forfeitures.
At March 31, 2007, there remained approximately $772,000 of unrecognized compensation
expense related to unvested employee stock options to be recognized as expense over a
weighted-average period of 1.61 years. Presented below is the Companys stock option activity:
|
|
|
|
|
|
|
|
|
|
|
Stock Options |
|
|
Three-Months Ended |
|
|
March 31, 2007 |
|
|
|
|
|
|
Weighted Average |
|
|
Number |
|
Exercise Price |
|
|
of Shares |
|
per Share |
Outstanding at January 1, 2007 |
|
|
6,858,208 |
|
|
$ |
1.66 |
|
Granted |
|
|
|
|
|
$ |
|
|
Exercised |
|
|
(325,333 |
) |
|
$ |
1.74 |
|
Forfeited |
|
|
(57,000 |
) |
|
$ |
1.46 |
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2007 |
|
|
6,475,875 |
|
|
$ |
1.66 |
|
|
|
|
|
|
|
|
|
|
Options exercisable at March 31, 2007 |
|
|
4,581,644 |
|
|
$ |
1.78 |
|
|
|
|
|
|
|
|
|
|
A summary of the activity for nonvested stock options as of March 31, 2007, and changes during
the three-month period is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Number |
|
Grant Date Fair |
|
|
of Shares |
|
Value per Share |
Nonvested at January 1, 2007 |
|
|
2,099,877 |
|
|
$ |
1.19 |
|
Granted |
|
|
|
|
|
$ |
|
|
Forfeited |
|
|
(37,000 |
) |
|
$ |
1.00 |
|
Vested |
|
|
(168,645 |
) |
|
$ |
1.11 |
|
|
|
|
|
|
|
|
|
|
Nonvested at March 31, 2007 |
|
|
1,894,232 |
|
|
$ |
1.20 |
|
|
|
|
|
|
|
|
|
|
9
The following table summarizes significant ranges of outstanding stock options under the three
plans at March 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
|
|
|
Number of |
|
|
|
|
Range of |
|
|
|
|
|
Contractual Life |
|
Weighted Average |
|
Options |
|
Weighted Average |
|
Weighted Average |
Exercise Prices |
|
Number of Options |
|
(years) |
|
Exercise Price |
|
Exercisable |
|
Contractual Life |
|
Exercise Price |
$0.25 1.00
|
|
|
1,041,876 |
|
|
|
7.31 |
|
|
$ |
0.80 |
|
|
|
660,717 |
|
|
|
6.82 |
|
|
$ |
0.80 |
|
$1.01 1.50
|
|
|
1,761,000 |
|
|
|
8.45 |
|
|
|
1.25 |
|
|
|
956,928 |
|
|
|
8.10 |
|
|
|
1.25 |
|
$1.51 2.00
|
|
|
2,097,500 |
|
|
|
6.92 |
|
|
|
1.86 |
|
|
|
1,398,500 |
|
|
|
6.77 |
|
|
|
1.86 |
|
$2.01 3.00
|
|
|
1,575,499 |
|
|
|
6.35 |
|
|
|
2.44 |
|
|
|
1,565,499 |
|
|
|
6.33 |
|
|
|
2.44 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,475,875 |
|
|
|
7.26 |
|
|
$ |
1.66 |
|
|
|
4,581,644 |
|
|
|
6.91 |
|
|
$ |
1.78 |
|
The aggregate intrinsic value of outstanding options as of March 31, 2007, was $19,604,000 of
which $13,338,000 is related to exercisable options. The aggregate intrinsic value was calculated
based on the positive difference between the closing fair market value of the Companys common
stock on March 31, 2007 ($4.69) and the exercise price of the underlying options. The intrinsic
value of options exercised was $961,000 for the three month period ended March 31, 2007, and the
intrinsic value of options that vested was approximately $603,000 during the period.
5. Liquidity and Capital Resources
At March 31, 2007, the Company had cash and cash equivalents of $36.4 million, and it received
$19.2 million from the sale of shares in its April 2007 financing transaction, net of offering
expenses of approximately $2.8 million, and the $15.0 million of net proceeds that it provided to
RXi on April 30, 2007 to satisfy the initial funding requirements under its agreements with UMMS.
Management believes that the Company has adequate financial resources to support its currently
planned level of operations into the second half of 2009, which expectation is based in part on
projected expenditures for 2007 of $4.5 million for the Companys Phase IIb trial of arimoclomol
for ALS and related studies, $4.4 million for its other ongoing and planned preclinical programs,
including a possible Phase II clinical trial of arimoclomol in stroke patients, and $8.8 million
for general and administrative expenses. Management estimates that RXi separately will expend
approximately $6.2 million on development activities for 2007 (including approximately $400,000 in
cash payments under agreements with UMMS, $3.2 million in other research and development expenses
and $2.6 million in general and administrative expenses). The Company will be required to obtain
additional funding in order to execute its long-term business plans, although it does not currently
have commitments from any third parties to provide it with capital. The Company cannot assure that
additional funding will be available on favorable terms, or at all. If the Company fails to obtain
additional funding when needed, it may not be able to execute its business plans and its business
may suffer, which would have a material adverse effect on its financial position, results of
operations and cash flows.
6. Equity Transactions
On March 2, 2006, the Company completed a $13.4 million private equity financing in which it
issued 10,650,794 shares of its common stock and warrants to purchase an additional 5,325,397
shares of its common stock at an exercise price of $1.54 per share. Net of investment banking
commissions, legal, accounting and other expenses related to the transaction, we received proceeds
of approximately $12.4 million.
In connection with the March 2006 financing, the Company adjusted the price and number of
underlying shares of warrants to purchase approximately 2.8 million shares that had been issued in
prior equity financings in May and September 2003. The adjustment was made as a result of
anti-dilution provisions in those warrants that were triggered by the Companys issuance of common
stock in the March 2006 financing at a price below the closing market price on the date of the transaction.
The Company accounted for the anti-dilution adjustments as deemed dividends analogous with the
guidance in Emerging Issues Task Force Issue (EITF) No. 98-5, Accounting for Convertible
Securities with Beneficial Conversion Features or Contingently Adjustable Conversion Ratios, and
EITF 00-27, Application of 98-5 to Certain Convertible Instruments, and recorded an approximate
$488,000 charge to retained earnings and a corresponding credit to additional paid-in capital.
In connection with the March 2006 private equity financing, the Company entered into a
registration rights agreement with the purchasers of its common stock and warrants. That agreement
provides, among other things, for liquidated damages, up to a maximum of 16% of the purchase price paid
for the securities (approximately $2.1 million), that are payable in the event that the Company
were unable to initially register or maintain the effective registration of the securities until
the sooner of two years or the date on which the securities could be sold pursuant to Rule 144 of
the Securities Act of 1933, as amended. The Company has evaluated the
liquidated damages of the
March 2006 registration rights agreement in light of FASB Staff Position No. EITF 00-19-2,
Accounting for Registration Payment Arrangements, which specifies that the contingent obligation to
make future payments or otherwise transfer consideration under a registration payment arrangement
should be separately recognized and measured in accordance with FASB Statement No. 5, Accounting
for Contingencies, pursuant to which a contingent obligation must be accrued only if it is
reasonably estimable and probable. In managements estimation, the contingent payments related to
the registration payment arrangement are not probably to occur, and thus no amount need be accrued.
10
During the three-month period ended March 31, 2007, the Company issued 6.9 million shares of
its common stock, and received $11.1 million, upon the exercise of stock options and warrants.
During the first quarter of 2007, the Company did not grant any new options.
7.
Subsequent Events
On April 19, 2007, the Company completed a $37.0 million private equity financing in which it
issued approximately 8.6 million shares of its common stock at a price of $4.30 per share. Net of
investment banking commissions, legal, accounting and other expenses related to the transaction,
the Company received proceeds of approximately $34.2 million. On April 30, 2007, the Company
contributed $15.0 million, net of reimbursed expenses of approximately $2.0 million paid by RXi to
the Company, in exchange for equity in RXi, to satisfy the initial funding requirements under its
agreements with UMMS.
In connection with the private equity financing, the Company adjusted the price and number of
underlying shares of warrants to purchase approximately 1.4 million shares that had been issued in
prior equity financings in May and September 2003. The adjustment was made as a result of
anti-dilution provisions in those warrants that were triggered by the Companys issuance of common
stock in the April 2007 financing at a price below the closing market price on the date of the
transaction. The Company accounted for the anti-dilution adjustments as deemed dividends analogous
with the guidance in Emerging Issues Task Force Issue (EITF) No. 98-5, Accounting for Convertible
Securities with Beneficial Conversion Features or Contingently Adjustable Conversion Ratios, and
EITF 00-27, Application of 98-5 to Certain Convertible Instruments. Because the fair value of the
outstanding warrants decreased as a result of the anti-dilution adjustment, no deemed dividend was
recorded, and thus the Company did not record a charge to retained earnings or a corresponding
credit to additional paid-in capital.
In connection with the April 2007 private equity financing, the Company entered into a
registration rights agreement with the purchasers of its common stock and warrants. That agreement
provides, among other things, for liquidated damages, up to a maximum of 16% of the purchase price paid
for the securities (approximately $5.9 million), that are payable in the event that the Company
were unable to initially register or maintain the effective registration of the securities until
the sooner of two years or the date on which the securities could be sold pursuant to Rule 144 of
the Securities Act of 1933, as amended. The Company has evaluated the penalty provisions of the
April 2007 registration rights agreement in light of FASB Staff Position No. EITF 00-19-2,
Accounting for Registration Payment Arrangements, which specifies that the contingent obligation to
make future payments or otherwise transfer consideration under a registration payment arrangement
should be separately recognized and measured in accordance with FASB Statement No. 5, Accounting
for Contingencies, pursuant to which a contingent obligation must be accrued only if it is
reasonably estimable and probable. In managements estimation, the contingent payments related to
the registration payment arrangement are not probable to occur, and thus no amount need be accrued.
As of April 30, 2007, the Company has received approximately $2.0 million in connection with
the exercise of warrants and options since March 31, 2007.
Item 2. Managements Discussion and Analysis of Financial Condition And Results of Operations
Forward Looking Statements
From time to time, we make oral and written statements that may constitute forward-looking
statements (rather than historical facts) as defined in the Private Securities Litigation Reform
Act of 1995 or by the Securities and Exchange Commission, or SEC, in its rules, regulations and
releases, including Section 27A of the Securities Act of 1933, as amended and Section 21E of the
Securities Exchange Act of 1934, as amended. We desire to take advantage of the safe harbor
provisions in the Private Securities Litigation Reform Act of 1995 for forward-looking statements
made from time to time, including, but not limited to, the forward-looking statements made in this
Quarterly Report on Form 10-Q, as well as those made in other filings with the SEC.
All statements in this Quarterly Report, including under the caption Managements Discussion
and Analysis of Financial Condition and Results of Operations, other than statements of historical
fact are forward-looking statements for purposes of these provisions, including statements of our
current views with respect to the recent developments regarding our RXi Pharmaceuticals Corporation
subsidiary, our business strategy, business plan and research and development activities, our
future financial results, and other future events. These statements include forward-looking
statements both with respect to us, specifically, and the biotechnology industry, in general. In
some cases, forward-looking statements can be identified by the use of terminology such as may,
will, expects, plans, anticipates, estimates, potential or could or the negative
thereof or other comparable terminology.
11
Although we believe that the expectations reflected in the forward-looking statements
contained herein are reasonable, there can be no assurance that such expectations or any of the
forward-looking statements will prove to be correct, and actual results could differ materially
from those projected or assumed in the forward-looking statements.
All forward-looking statements involve inherent risks and uncertainties, and there are or will
be important factors that could cause actual results to differ materially from those indicated in
these statements. We believe that these factors include, but are not limited to, those factors set
forth in this Quarterly Report under the captions Risk Factors and Managements Discussion and
Analysis of Financial Condition and Results of Operations, all of which you should review
carefully. If one or more of these or other risks or uncertainties materialize, or if our
underlying assumptions prove to be incorrect, actual results may vary materially from what we
anticipate. Please consider our forward-looking statements in light of those risks as you read
this Quarterly Report. We undertake no obligation to publicly update or review any forward-looking
statement, whether as a result of new information, future developments or otherwise.
Overview
We are a biopharmaceutical research and development company engaged in developing human
therapeutic products based primarily upon our small molecule molecular chaperone co-induction
technology. We recently completed a Phase IIa clinical trial of our lead small molecule product
candidate, arimoclomol, for the treatment of amyotrophic lateral sclerosis, which is commonly known
as ALS or Lou Gehrigs disease. Arimoclomol has received Orphan Drug and Fast Track designation
from the U.S. Food and Drug Administration, or FDA, and orphan medicinal product status from the
European Commission for the treatment of ALS. The Company plans to initiate a Phase IIb trial of
arimoclomol for this indication during the second half of 2007, subject to FDA clearance.
Additionally, recent preclinical animal studies indicated that arimoclomol accelerated the recovery
of sensory and motor functions following a stroke, even when administered up to 48 hours after the
stroke. Based upon these positive indications, we are considering a possible Phase II clinical
trial of arimoclomol in stroke patients. We are also pursuing clinical development of our other
small molecule product candidates, as well as a novel HIV DNA + protein vaccine exclusively
licensed to us and developed by researchers at the University of Massachusetts Medical School, or
UMMS, and Advanced BioScience Laboratories with funding from the National Institutes of Health.
We are also engaged in developing therapeutic products based upon ribonucleic acid
interference, or RNAi, which has the potential to effectively treat a broad array of diseases by
interfering with the expression of targeted disease-associated genes. In order to fully realize the
potential value of our RNAi technologies, in January 2007 we transferred to RXi Pharmaceuticals
Corporation, our majority-owned subsidiary, substantially all of our RNAi-related technologies and
assets in exchange for equity in RXi. These assets consisted primarily of our licenses from UMMS
and the Carnegie Institution of Washington relating to fundamental RNAi technologies, as well as
research and other equipment situated at our Worcester, Massachusetts, laboratory. On April 30,
2007, we provided to RXi $15.0 million, net of expenses of approximately $2.0 million reimbursed to
us by RXi, in exchange for additional equity in RXi, to satisfy certain initial funding
requirements under its agreements with UMMS. RXi is focused solely on developing and
commercializing therapeutic products based upon RNAi technologies for the treatment of human
diseases, with an initial focus on neurodegenerative diseases, cancer, type 2 diabetes and obesity.
We have relied primarily upon selling equity securities and upon proceeds received upon the
exercise of options and warrants and, to a much lesser extent, upon payments from our strategic
partners and licensees, to generate funds needed to finance our business and operations. At March
31, 2007, we had cash and cash equivalents of $36.4 million, and we received $19.2 million from the
sale of shares in its April 2007 financing transaction, net of offering expenses of approximately
$2.8 million and the $15.0 million of net proceeds that it provided to RXi on April 30, 2007 to
satisfy the initial funding requirements under its agreements with UMMS. We believe that we have
adequate financial resources to support our currently planned level of operations into the second
half of 2009, which expectation is based in part on projected expenditures for 2007 of $4.5 million
for our Phase IIb trial of arimoclomol for ALS and related studies, $4.4 million for our other
ongoing and planned preclinical programs, including a possible Phase II clinical trial of
arimoclomol in stroke patients, and $8.8 million for general and administrative expenses.
Management estimates that RXi separately will expend approximately $6.2 million on development
activities for 2007 (including approximately $400,000 in cash payments under recent agreements with
UMMS, $3.2 million in other research and development expenses and $2.6 million in general and
administrative expenses). We have no significant revenue, and we expect to have no significant
revenue and to continue to incur significant losses over the next several years. Our net losses may
increase from current levels primarily due to expenses related to our ongoing and planned clinical
trials, research and development programs, possible technology acquisitions, and other general
corporate activities. We anticipate, therefore, that our operating results will fluctuate for the
foreseeable future and period-to-period comparisons should not be relied upon as predictive of the
results in future periods.
12
We have agreed to reduce our share of ownership of RXi to less than a majority of the
outstanding voting power as soon as reasonably practicable. In order to reduce our ownership
interest in RXi, we have announced our intention to issue a dividend of a portion of our RXi shares
to our stockholders. Any proposed dividend to our stockholders of RXi shares would be subject to
approval of the CytRx board of directors, SEC rules and the requirements of the Delaware General
Corporation Law. We may be unable to comply with these rules and requirements, or may experience
delays in complying. Any such dividend may be taxable to CytRx.
RXi began operating as a stand-alone company with its own management, business, and operations
in January 2007. Following RXis initial funding, we have agreed under our letter agreement with
UMMS and our separate stockholders agreement with RXi and its other current stockholders to reduce
our share of ownership of RXi to less than a majority of the outstanding voting power as soon as
reasonably practicable. During the time that RXi is majority-owned, the consolidated financial
statements of CytRx will include 100% of the assets and liabilities of RXi and the ownership of the
interests of the minority shareholders will be recorded as minority interests. In the future, if
CytRx owns more than 20% but less than 50% of the outstanding shares of RXi, CytRx would account
for its investment in RXi using the equity method. Under the equity method, CytRx would record its
pro-rata share of the gains or losses of RXi against its historical basis investment in RXi. For
2007, we expect RXis research and development expenses will be approximately $6.2 million.
Critical Accounting Policies and Estimates
Managements discussion and analysis of our financial condition and results of operations are
based on our consolidated financial statements, which have been prepared in accordance with
accounting principles generally accepted in the United States. The preparation of these financial
statements requires management to make estimates and judgments that affect the reported amounts of
assets, liabilities, revenue and expenses, and related disclosure of contingent assets and
liabilities. On an ongoing basis, management evaluates its estimates, including those related to
revenue recognition, bad debts, impairment of long-lived assets, including finite lived intangible
assets, accrued liabilities and certain expenses. We base our estimates on historical experience
and on various other assumptions that are believed to be reasonable under the circumstances, the
results of which form the basis for making judgments about the carrying values of assets and
liabilities that are not readily apparent from other sources. Actual results may differ materially
from these estimates under different assumptions or conditions.
Our significant accounting policies are summarized in Note 2 to our financial statements
contained in our Annual Report on Form 10-K filed for the year ended December 31, 2006. We believe
the following critical accounting policies affect our more significant judgments and estimates used
in the preparation of our consolidated financial statements:
Revenue Recognition
Biopharmaceutical
revenues have consisted of license fees from strategic alliances with
pharmaceutical companies, service revenues from contract research
and laboratory consulting, and grant revenues from government and private grants.
Monies received for license fees are deferred and recognized ratably over the performance
period in accordance with Staff Accounting Bulletin (SAB) No. 104, Revenue Recognition. Milestone
payments will be recognized upon achievement of the milestone as long as the milestone is deemed
substantive and we have no other performance obligations related to the milestone and
collectibility is reasonably assured, which is generally upon receipt, or recognized upon
termination of the agreement and all related obligations. Deferred revenue represents amounts
received prior to revenue recognition.
Revenues from contract research, government grants, and consulting fees are recognized over
the respective contract periods as the services are performed, provided there is persuasive
evidence or an arrangement, the fee is fixed or determinable and collection of the related
receivable is reasonably assured. Once all conditions of the grant are met and no contingencies
remain outstanding, the revenue is recognized as grant fee revenue and an earned but unbilled
revenue receivable is recorded.
In
August 2006, we received approximately $24.3 million in
proceeds from the privately-funded ALS Charitable
Remainder Trust (ALSCRT) in exchange for the commitment to continue research and development of
arimoclomol and other potential treatments for ALS and a one percent royalty in the worldwide sales
of arimoclomol. Under the arrangement, we retain the rights to any products or intellectual
property funded by the arrangement and the proceeds of the transaction are non-refundable. Further,
the ALSCRT has no obligation to provide any further funding to us. We have analyzed the transaction
and concluded that due to the research and development components of the transaction that it is
properly
13
accounted for under SFAS No. 68, Research and Development Arrangements. Accordingly, we have
recorded the value received under the arrangement as deferred service revenue and will recognize
service revenue using the proportional performance method of revenue recognition, meaning that
service revenue is recognized on a dollar-for-dollar basis for each dollar of expense incurred for
the research and development of arimoclomol and then the development of other potential ALS
treatments. We believe that this method best approximates the efforts expended related to the
services provided. We adjust our estimates quarterly. For the quarter ended
March 31, 2006, we recognized approximately $1.4 million in service revenue.
The amount of deferred revenues, current portion is the amount of deferred revenues that are
expected to be recognized in the next twelve months and are subject to fluctuation based upon
management estimates. Managements estimates include what pre-clinical and clinical trials are
necessary, the size of the trial, the timing of when trials will be performed and the estimated
cost of the trials. These estimates are subject to changes and could have a significant effect on
the amount and timing of when the deferred revenues are recognized.
Any significant change in ALS related research and development
expense in any particular quarterly or annual period will result in a
change in the recognition of revenue for that period and consequently
affect the comparability or revenue from period to period.
Research and Development Expenses
Research and development expenses consist of costs incurred for direct and overhead-related
research expenses and are expensed as incurred. Costs to acquire technologies which are utilized in
research and development and which have no alternative future use are expensed when incurred.
Technology developed for use in its products is expensed as incurred until technological
feasibility has been established.
Clinical Trial Expenses
Clinical trial expenses, which are included in research and development expenses, include
obligations resulting from our contracts with various clinical research organizations in connection
with conducting clinical trials for our product candidates. We recognize expenses for these
activities based on a variety of factors, including actual and estimated labor hours, clinical site
initiation activities, patient enrollment rates, estimates of external costs and other
activity-based factors. We believe that this method best approximates the efforts expended on a
clinical trial with the expenses we record. We adjust our rate of clinical expense recognition if
actual results differ from our estimates.
Stock-based Compensation
Effective
January 1, 2006, we adopted the provisions of SFAS 123(R),
Share-Based Payment (Revised 2004).
SFAS 123(R) requires that companies recognize compensation expense associated with stock option
grants and other equity instruments to employees in the financial statements. SFAS 123(R) applies
to all grants after the effective date and to the unvested portion of stock options outstanding as
of the effective date. We are using the modified-prospective method and the Black-Scholes valuation
model for valuing the share-based payments. We will continue to account for transactions in which
services are received in exchange for equity instruments based on the fair value of such services
received from non-employees, in accordance with SFAS 123(R) and Emerging Issues Task Force (EITF)
Issue No. 96-18, Accounting for Equity Instruments that Are Issued to Other than Employees for
Acquiring, or in Conjunction with Selling, Goods or Services.
The
fair value of each option grant is estimated using the Black-Scholes
option-pricing model, with the following weighted average assumptions
used for grants in 2006: risk-free interest rates of 4.9; expected
volatility of 111.6%; expected life of the options of 6.0 years;
and no dividends made. Based on historical experience, for 2006, we
estimated an annualized forfeiture rate of 10% for options granted to
employees and 3% for options granted to senior management and
directors. In 2007 we increased our forfeiture rate for employees to
15% in anticipation of employees transferring to RXi. We maintained
the same forfeiture rate for senior management and directors.
Impairment of Long-Lived Assets
We review long-lived assets, including finite lived intangible assets, for impairment on an
annual basis, as of December 31, or on an interim basis if an event occurs that might reduce the
fair value of such assets below their carrying values. An impairment loss would be recognized based
on the difference between the carrying value of the asset and its estimated fair value, which would
be determined based on either discounted future cash flows or other appropriate fair value methods.
Earnings
Per Share
Basic and diluted loss per common share are computed based on the weighted average number of
common shares outstanding. Common share equivalents (which consist of options and warrants) are
excluded from the computation of diluted loss per share since the effect would be antidilutive.
Common share equivalents which could potentially dilute basic earnings per share in the future, and
which were excluded from the computation of diluted loss per share,
totaled approximately 22.7 million shares and 29.0 million shares at March 31, 2007 and 2006, respectively. In
connection with our adjustment to the exercise terms of certain outstanding warrants to purchase
common stock on March 2, 2006, we recorded a deemed dividend of $488,000. This deemed dividend was
reflected as an adjustment to net loss for the first quarter of 2006 to arrive at net loss
applicable to common stockholders on the condensed consolidated statement of operations and for purposes of
calculating basic and diluted earnings per shares.
Liquidity and Capital Resources
At March 31, 2007, we had cash and cash equivalents of $36.4 million and total assets of $38.1
million, compared to $30.4 million and $31.7 million, respectively, at December 31, 2006. Working
capital totaled $27.5 million at March 31, 2007, compared to $20.3 million at December 31, 2006.
14
We have relied primarily upon selling equity securities and upon proceeds received upon the
exercise of options and warrants and, to a much lesser extent, upon payments from our strategic
partners and licensees, to generate funds needed to finance our business and operations. At March
31, 2007, we had cash and cash equivalents of $36.4 million, and we received $19.2 million from the
sale of shares in its April 2007 financing transaction, net of offering expenses of approximately
$2.8 million and the $15.0 million of proceeds, net of approximately $2.0 million of reimbursed
expenses, that we provided to RXi on April 30, 2007 to satisfy the initial funding requirements
under its agreements with UMMS. We believe that we have adequate financial resources to support its
currently planned level of operations into the second half of 2009, which expectation is based in
part on projected expenditures for 2007 of $4.5 million for our Phase IIb trial of arimoclomol for
ALS and related studies, $4.4 million for our other ongoing and planned preclinical programs,
including a possible Phase II clinical trial of arimoclomol in stroke patients, and $8.8 million
for general and administrative expenses. Management estimates that RXi separately will expend
approximately $6.2 million on development activities for 2007 (including approximately $400,000 in
cash payments under recent agreements with UMMS, $3.2 million in other research and development
expenses and $2.6 million in general and administrative expenses). We have no significant revenue,
and we expect to have no significant revenue and to continue to incur significant losses over the
next several years. Our net losses may increase from current levels primarily due to expenses
related to our ongoing and planned clinical trials, research and development programs, possible
technology acquisitions, and other general corporate activities. In the event that actual costs of
our clinical program for ALS, or any of our other ongoing research activities, are significantly
higher than our current estimates, we may be required to significantly modify our planned level of
operations. In the future, we will be dependent on obtaining financing from third parties in order
to maintain our operations, including completion of the clinical development arimoclomol for ALS
and our ongoing research and development efforts related to our other small molecule drug
candidates.
We currently have no commitments from any third parties to provide us with capital. We cannot
assure that additional funding will be available to us on favorable terms, or at all. If we fail to
obtain additional funding when needed in the future, we would be forced to scale back, or
terminate, our operations, or to seek to merge with or to be acquired by another company.
Our net loss, as adjusted for noncash charges relating to (1) common stock, stock option and
warrants issued for services and (2) expenses related to employee stock options, declined by
approximately $196,000 from the quarter ended March 31, 2006 to the quarter ended March 31, 2007.
This decline in net loss was more than offset by an approximately $1.5 million increase in the use
of cash for the net change in operating assets and liabilities between the two quarters resulting
in an increase in cash used in operating activities from approximately $3.9 million for the
three-month period ended March 31, 2006 to approximately $5.1 million for the three-month period
ended March 31, 2007.
In the three-month periods ended March 31, 2007 and 2006, net cash used in investing
activities consisted of approximately $2,500 and $23,000, respectively, for the purchase of
equipment. We expect capital spending during the remaining three quarters of 2007 to be higher than
the first quarter of 2007 due to the purchase of additional laboratory equipment.
Cash provided by financing activities in the three-month period ended March 31, 2007 was $11.1
million. The cash provided by financing activities consisted almost exclusively of approximately
$11.1 million received from the exercise of stock options and warrants. Cash provided by financing
activities in the three-month period ended March 31, 2006 was approximately $12.7 million. During
that period, we raised $12.4 million, net of expenses, from the issuance of common stock in a
private equity financing in March of 2006, and received proceeds from the exercise of stock options
and warrants of approximately $334,000.
No common stock was issued in the quarter ending March 31, 2007; however, in April 2007, we
raised $34.2 million, net of offering expenses of approximately $2.8 million, from the sale of 8.6 million shares in a financing transaction. We subsequently contributed $15.0 million to RXi, net
of expenses of approximately $2.0 million reimbursed to us by RXi, on April 30, 2007 to satisfy the initial funding requirements
under our agreements with UMMS.
As a result of the activities described above, our cash and cash equivalents increased by
approximately $6.0 million during the quarter ended March 31, 2007, compared to an increase of
approximately $8.8 million during the quarter ended March 31, 2006.
We are evaluating other potential future sources of capital, although we do not currently have
commitments from any third parties to provide us with capital. The results of our technology
licensing efforts and the actual proceeds of any fund-raising activities will determine our ongoing
ability to operate as a going concern. Our ability to obtain future financings through joint
ventures, product licensing arrangements, royalty sales, equity financings, gifts, and grants or
otherwise is subject to market conditions and out ability to identify parties that are willing and
able to enter into such arrangements on terms that are satisfactory to us. Depending upon the
15
outcome of our fundraising efforts, the accompanying financial information may not necessarily
be indicative of future operating results or future financial condition.
We expect to incur significant losses for the foreseeable future and there can be no assurance
that we will become profitable. Even if we become profitable, we may not be able to sustain that
profitability.
Results of Operations
We recorded a net loss applicable to common shareholders of approximately $4.5 for the three
month period ended March 31, 2007, compared to a $4.7 million loss for the same period in 2006.
We recognized approximately $1.6 million of revenue, of which $1.4 million resulted from our
$24.3 million sale to the ALS Charitable Remainder Trust of a 1% royalty interest in worldwide
sales of arimoclomol in 2007. All future licensing fees under our current licensing agreements are
dependent upon successful development milestones being achieved by the licensor. During 2007, we do
not anticipate receiving any significant service or licensing fees, although we estimate that we
will recognize an additional $3.1 million in service revenues from the ALS Charitable Remainder
Trust transaction. We will continue to recognize the balance of the deferred revenue recorded from
the royalty transaction with the ALS Charitable Remainder Trust over the period of our
arimoclomol research.
Research and Development
|
|
|
|
|
|
|
|
|
|
|
Quarters Ended March 31, |
|
|
|
2007 |
|
|
2006 |
|
|
|
(In thousands) |
|
Research and development expense |
|
$ |
3,623 |
|
|
$ |
2,130 |
|
Non-cash research and development expense |
|
|
281 |
|
|
|
44 |
|
Employee stock option expense |
|
|
37 |
|
|
|
83 |
|
Depreciation and amortization |
|
|
67 |
|
|
|
55 |
|
|
|
|
|
|
|
|
|
|
$ |
4,008 |
|
|
$ |
2,312 |
|
Research expenses are expenses incurred by us in the discovery of new information that will
assist us in the creation and the development of new drugs or treatments. Development expenses are
expenses incurred by us in our efforts to commercialize the findings generated through our research
efforts.
Research and development expenses incurred during the first three months of 2007 and 2006
relate primarily to (i) our Phase II clinical program for arimoclomol in ALS, (ii) our ongoing
research and development related to other molecular chaperone drug candidates, (iii) our research
and development activities conducted at UMMS related to the technologies covered by the UMMS
license agreements, (iv) our prior collaboration and invention disclosure agreement pursuant to
which UMMS had agreed to disclose certain inventions to us and provide us with the right to acquire
an option to negotiate exclusive licenses for those disclosed technologies, and (v) the small
molecule drug discovery operations at our Massachusetts laboratory. All research and development
costs related to the activities of RXi and our laboratory were expensed.
As compensation to members of our scientific advisory board and consultants, and in connection
with the acquisition of technology, we sometimes issue shares of our common stock, stock options
and warrants to purchase shares of our common stock. For financial statement purposes, we value
these shares of common stock, stock options, and warrants at the fair value of the common stock,
stock options or warrants granted, or the services received, whichever is more reliably measurable.
We recorded non-cash charges of $976,000 and $112,000 in this regard during the quarters ended March
31, 2007 and 2006, respectively. With our adoption of SFAS 123(R) during 2006, we recorded $37,000
and $83,000 of employee stock option expense during the quarters ended March 31, 2007 and 2006,
respectively.
In 2007, we expect our research and development expenses to increase primarily as a result of
our ongoing Phase II clinical program with arimoclomol and related studies for the treatment of
ALS, our potential Phase II clinical trial of arimoclomol for stroke recovery and the continued
development of our RNAi assets by our majority-owned subsidiary RXi. We currently estimate that our
clinical program for arimoclomol for the treatment of ALS, including the completion of the planned
Phase IIb clinical trial and related studies, will require us to incur approximately $23.0 million
over the next two to three years.
16
General and administrative expenses
|
|
|
|
|
|
|
|
|
|
|
Quarters Ended March 31, |
|
|
|
2007 |
|
|
2006 |
|
|
|
(In thousands) |
|
General and administrative expenses |
|
$ |
2,369 |
|
|
$ |
1,689 |
|
Stock, stock options and warrant expense to non-employees and consultants |
|
|
|
|
|
|
68 |
|
Employee stock option expense |
|
|
112 |
|
|
|
262 |
|
Depreciation and amortization |
|
|
4 |
|
|
|
4 |
|
|
|
|
|
|
|
|
|
|
$ |
2,485 |
|
|
$ |
2,023 |
|
|
|
|
|
|
|
|
General and administrative expenses include all salaries and general corporate expenses,
including legal expenses associated with the prosecution of our intellectual property. General and
administrative expenses increased by approximately $0.5 million in the quarter ended March 31, 2007
compared to the same quarter in 2006 as a result of annual salary increases and increased bonuses
and legal expenses. During 2007, we expect legal expenses to remain consistent with 2006 levels, as
we expect patent expenses to increase, while being off-set by a decline in legal expenses
associated with the formation of RXi. In our efforts to comply with the attestation requirements
under Section 404 of the Sarbanes-Oxley Act for the first time for the year ended December 31,
2006, we incurred approximately $800,000 in consulting, audit and accounting system conversion
expense. We expect to those expenses to decrease in 2007, as our accounting system conversion is
now complete.
From time to time, we issue shares of our common stock or warrants or options to purchase
shares of our common stock to consultants and other service providers in exchange for services. For
financial statement purposes, we value these shares of common stock, stock options, and warrants at
the fair value of the common stock, stock options or warrants granted, or the services received,
whichever we can measure more reliably. We recorded no non-cash charges during the quarter ended
March 31, 2007, and approximately $68,000 during the quarter ended March 31, 2006. These charges
relate primarily to common stock, stock options and warrants issued in connection with the
engagement and retention of financial, business development and scientific advisors. With our
adoption of SFAS 123(R) during 2006, we recorded approximately $112,000 and $262,000 of employee
stock option expense during the quarters ended March 31, 2007 and 2006, respectively.
Interest
and dividend income
Interest
and dividend income was $383,000 for the quarter ended March 31, 2007, compared to $107,000 for the
quarter ended March 31, 2006. The variances between years is attributable primarily to the amount
of cash available for investment each year and, to a lesser extent, changes in prevailing market
rates.
Minority interest in losses of subsidiary
We offset against our net loss $2,000 related to the minority interest in RXi held by its
minority stockholders in the quarter ended March 31, 2007. During 2006 no comparable entry was
necessary as all our subsidiaries were wholly owned. This loss was the minority shareholders
portion of the loss attributed to RXi and was limited to the extent of their investment.
Related Party Transactions
Dr. Michael Czech, who is a member of the Companys Scientific Advisory Board, is an employee
of UMMS and was the principal investigator for a sponsored research agreement between the Company
and UMMS. During the three-month period ended March 31, 2006, we incurred expenses to UMMS related
to Dr. Czechs sponsored research agreement of $201,000. Additionally, we paid $27,000 to Dr. Czech
for his services on the Scientific Advisory Board for each of the three-month periods ended March 31, 2007 and 2006.
RXi was incorporated jointly in April 2006 by CytRx and the four current members of RXis
scientific advisory board for the purpose of pursuing the possible development or acquisition of
RNAi-related technologies and assets.
17
On January 8, 2007, CytRx entered into a Contribution Agreement with RXi under which CytRx
assigned and contributed to RXi substantially all of its RNAi-related technologies and assets, and
entered into a letter agreement with RXi under which RXi has agreed to reimburse CytRx, following
its initial funding, for all organizational and operational expenses incurred by CytRx in
connection with the formation, initial operations and funding of RXi. On April 30, 2007, CytRx
additionally contributed $15 million, net of reimbursed expenses of approximately $2.0 million, to
RXi.
Tod Woolf, Ph.D., the President and Chief Executive Officer of RXi, is one of the Companys
executive officers. The Company recently entered into an employment agreement with Dr. Woolf under
which he is entitled to base annual compensation and other employee benefits, including the right
to receive, upon completion of RXis initial funding, a grant by RXi of stock options to purchase a
number of shares of RXi common stock equal to 3/70ths of the number of RXi shares held by CytRx
immediately prior to the initial funding at an exercise price equal to the fair market value of the
shares at the time of grant.
Dr. Woolf may be deemed to have a material interest in the Companys transactions with RXi
described above, and in its future dealings with RXi, by reason his status as RXis President and
Chief Executive Officer and in light of any stock options granted to him by RXi upon completion of
its initial funding or otherwise.
Item 3 Quantitative and Qualitative Disclosures About Market Risk
Our exposure to market risk is limited primarily to interest income sensitivity, which is
affected by changes in the general level of United States interest rates, particularly because a
significant portion of our investments are in short-term debt securities issued by the U.S.
government and institutional money market funds. The primary objective of our investment activities
is to preserve principal. Due to the nature of our short-term investments, we believe that we are
not subject to any material market risk exposure. We do not have any derivative financial
instruments or foreign currency instruments. If interest rates had varied by 10% in the three month
period ended March 31, 2007, it would not have had a material effect on our results of operations
or cash flows for that period.
Item 4 Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial
Officer, performed an evaluation of the effectiveness of the design and operation of our disclosure
controls and procedures (as defined in Securities Exchange Act Rule 13a-15(e)) as of the end of the
quarterly period covered by this Form 10-Q. Based on that evaluation, our Chief Executive Officer
and Chief Financial Officer concluded that our disclosure controls and procedures were effective to
ensure that information required to be disclosed by us in reports that we file or submit under the
Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time
periods specified in the rules and forms of the SEC.
Changes in Controls Over Financial Reporting
During the quarterly period covered by this report on Form 10-Q, we made changes to our
internal control designed to strengthen our financial reporting in light of material weaknesses in
that regard reported in our Form 10-K for the year ended December 31, 2006. During the quarterly
period covered by this Form 10-Q, we restated our financial statements for the first three fiscal
quarters in 2006 to reflect the proper accounting resulting from the integration of our
laboratorys accounting system in the first quarter of 2006, and enhanced our internal review of
all equity transactions to ensure the effectiveness of all aspects of our controls related to the
accounting for anti-dilution adjustments to our outstanding warrants and other securities..
We are continuing our efforts to improve and strengthen our control processes to fully remedy
the previously reported material deficiency and to ensure that all of our controls and procedures
are adequate and effective. Any failure to implement and maintain improvements in the controls over
our financial reporting could cause us to fail to meet our reporting obligations under the
Securities and Exchange Commissions rules and regulations. Any failure to improve our internal
controls to address the weakness we have identified could also cause investors to lose confidence
in our reported financial information, which could have a negative impact on the trading price of
our common stock.
18
PART II OTHER INFORMATION
Item 1A Risk Factors
We Have Operated at a Loss and Will Likely Continue to Operate at a Loss For the Foreseeable
Future
We have operated at a loss due to our lack of significant recurring revenue combined with our
substantial expenditures for research and development of our products and general and
administrative expenses. We incurred net losses of $16.8 million, $15.1 million and $16.4 million
for the years ended December 31, 2006, 2005 and 2004, respectively, and had an accumulated deficit
of approximately $139.6 million as of December 31, 2006. We are likely to continue to incur losses
unless and until, if ever, we are able to commercialize one or more of our products and generate
significant recurring revenue.
We Have No Source of Significant Recurring Revenue, Which Makes Us Dependent on Financing to
Sustain Our Operations
Our revenue was $2.1 million, $184,000 and $428,000 during the years ended December 31, 2006,
2005 and 2004, respectively. Of the $2.1 million of revenue in 2006, $1.8 million related to our
sale to the ALS Charitable Remainder Trust of a one-percent royalty interest in worldwide sales of
arimoclomol. We will not have other significant recurring revenue until at least one of the
following occurs:
|
|
|
We are able to commercialize one or more of our products in development, which may
require us to first enter into license or other arrangements with third parties. |
|
|
|
|
One or more of our licensed products is commercialized by our licensees, thereby generating royalty revenue for us. |
|
|
|
|
We are able to acquire products from third parties that are already being marketed or are approved for marketing. |
We have relied primarily upon proceeds from sales of our equity securities, including proceeds
received upon the exercise of options and warrants, to generate funds needed to finance our
business and operations. At March 31, 2007, we had cash and cash equivalents of $36.4 million, and
we received $19.2 million from the sale of shares in an April 2007 financing transaction, net of
offering expenses of approximately $2.8 million and the $15.0 million of net proceeds
that we provided to RXi on April 30, 2007 to satisfy the initial funding requirements under its
agreements with UMMS. We believe that our remaining current financial resources will be adequate
to support our currently planned level of operations into the second half of 2009. This estimate is
based in part on projected expenditures for 2007 of $4.5 million for our Phase IIb trial of
arimoclomol for ALS and related studies, $4.4 million for our other ongoing and planned
preclinical programs, including a possible Phase II clinical trial of arimoclomol in stroke
patients, and $8.8 million for general and administrative expenses. We estimate that RXi
separately will expend approximately $6.2 million on development activities for 2007 (including
approximately $400,000 in cash payments under agreements with UMMS, $3.2 million in other research
and development expenses and $2.6 million in general and administrative expenses). We anticipate it
will take a minimum of three years, and possibly longer, for us to generate recurring revenue, and
we will be dependent on obtaining future financing until such time, if ever, as we can generate
significant recurring revenue. We have no commitments from third parties to provide us with any
financing, and may not be able to obtain financing on favorable terms, or at all. A lack of needed
financing might force us to reduce the scope of our long-term business plans.
We Will Be Reliant Upon Third Parties for the Development and Eventual Marketing of Our Products
Our business plan is to enter into strategic alliances, license agreements or other
collaborative arrangements with other pharmaceutical companies under which those companies will be
responsible for the commercial development and eventual marketing of our products. Although we plan
to continue the development of arimoclomol for the treatment of ALS and may market it ourselves if
it is approved by the FDA, the completion of the development of our current product candidates, as
well as the manufacture and marketing of these products, will likely require us to enter into
strategic arrangements with other pharmaceutical or biotechnology companies.
There can be no assurance that any of our products will have sufficient potential commercial
value to enable us to secure strategic arrangements with suitable companies on attractive terms, or
at all. If we are unable to enter into such arrangements, we may not have the financial or other
resources to complete the development of any of our products. We do not have a commercial
relationship with the company that provided an adjuvant for the vaccine for the Phase I clinical
trial conducted by UMMS and Advanced BioScience
19
Laboratories on an HIV vaccine candidate that utilizes a technology that we licensed from
UMMS. If we are not able to enter into such a relationship, we may be unable to use some or all of
the results of the clinical trial as part of our clinical data for obtaining FDA approval of this
vaccine, which will delay the development of the vaccine.
To the extent we enter into collaborative arrangements, we will be dependent upon the
timeliness and effectiveness of the development and marketing efforts of our contractual partners.
If these companies do not allocate sufficient personnel and resources to these efforts or encounter
difficulties in complying with applicable FDA and other regulatory requirements, the timing of
receipt or amount of revenue from these arrangements may be materially and adversely affected. By
entering into these arrangements rather than completing the development and then marketing these
products on our own, we may suffer a reduction in the ultimate overall profitability for us of
these products. In addition, if we are unable to enter into these arrangements for a particular
product, we may be required to either sell our rights in the product to a third party or abandon it
unless we are able to raise sufficient capital to fund the substantial expenditures necessary for
development and marketing of the product.
We Will Incur Substantial Expenses and May Be Required to Pay Substantial Milestone Payments
Relating to Our Product Development Efforts
We estimate that our clinical program for arimoclomol for the treatment of ALS, including the
completion of the planned Phase IIb clinical trial and related studies, will require us to incur
approximately $23.0 million (including amounts payable under the Master Agreement for Clinical
Trials Management Services we have entered into with Pharmaceutical Research Associates) over the
next two to three years, assuming we receive FDA clearance for this trial. In addition, our
agreement with Biorex by which we acquired our molecular chaperone co-induction drug candidates
provides for milestone payments based on the occurrence of certain regulatory filings and approvals
related to the acquired products. In the event that we successfully develop arimoclomol or any
other of these candidates, the milestone payments could aggregate as much as $3.7 million, with the
most significant of those payments due upon the first commercialization of any of these candidates.
The actual costs of our planned Phase IIb trial, and any clinical development of arimoclomol in
stroke patients, could significantly exceed the expected amount due to a variety of factors
associated with the conduct of clinical trials, including those described below under If Our
Products Are Not Successfully Developed and Approved by the FDA, We May Be Forced to Reduce or
Curtail Our Operations.
Under our license for our HIV vaccine candidate, we are responsible for all of the costs for
any subsequent clinical trials for this vaccine. The costs of subsequent trials for the HIV
vaccine, if initiated, would be very substantial. Although we are seeking National Institutes of
Health or other governmental funding for these future trials, there can be no assurance that we
will be able to secure any such funding. We also will be responsible for milestone payments based
upon the development of the vaccine.
If Our Products Are Not Successfully Developed and Approved by the FDA, We May Be Forced to
Reduce or Curtail Our Operations
All of our products in development must be approved by the FDA or foreign governmental
agencies before they can be marketed. The process for obtaining FDA and foreign governmental
approvals is both time-consuming and costly, with no certainty of a successful outcome. This
process typically includes the conduct of extensive pre-clinical and clinical testing, which may
take longer or cost more than we or our licensees anticipate, and may prove unsuccessful due to
numerous factors. Product candidates that may appear to be promising at early stages of development
may not successfully reach the market for a number of reasons. The results of preclinical and
initial clinical testing of these products may not necessarily indicate the results that will be
obtained from later or more extensive testing. Companies in the pharmaceutical and biotechnology
industries have suffered significant setbacks in advanced clinical trials, even after obtaining
promising results in earlier trials.
Numerous factors could affect the timing, cost or outcome of our drug development efforts,
including the following:
|
|
|
Difficulty in securing centers to conduct trials. |
|
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|
|
Difficulty in enrolling patients in conformity with required protocols or projected timelines. |
|
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|
|
Unexpected adverse reactions by patients in trials. |
|
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|
Difficulty in obtaining clinical supplies of the product. |
20
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Changes in FDA or foreign governmental requirements for our testing during the course of that testing. |
|
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Inability to generate statistically significant data confirming the efficacy of the product being tested. |
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Modification of the drug during testing. |
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Reallocation of our limited financial and other resources to other clinical programs. |
It is possible that none of the products we develop will obtain the appropriate regulatory
approvals necessary for us to begin selling them. The time required to obtain FDA and foreign
governmental approvals is unpredictable, but often can take years following the commencement of
clinical trials, depending upon the complexity of the drug candidate. Any analysis we perform of
data from clinical activities is subject to confirmation and interpretation by regulatory
authorities, which could delay, limit or prevent regulatory approval. Any delay or failure in
obtaining required approvals could have a material adverse effect on our ability to generate
revenue from the particular drug candidate.
Our Molecular Chaperone Co-Induction Drug Candidates May Not Receive Regulatory Marketing
Approvals
In September 2006, we announced results of our Phase IIa clinical testing of arimoclomol for
the treatment of ALS. We reported that arimoclomol had met the trials primary endpoints of safety
and tolerability at all three doses tested in the Phase IIa trial, and that the trial results
indicated a non-statistically-significant trend of improvement in functional capacity as measured
by the Revised ALS Functional Ration Scale in the arimoclomol high dose group as compared with
untreated patients. There is no assurance, however, that the results and achievements described
will be supported by further analysis of the Phase IIa trial or open-label extension data, or by
the results of any subsequent clinical trials, or that the FDA will permit us to commence our
planned Phase IIb clinical on a timely basis or at all. The requirements imposed by the FDA in
connection with our planned Phase IIb trial could add to the time and expense for us to carry out
this trial.
We believe that the FDA may accept the completion of a successful Phase II clinical program as
sufficient to enable us to submit a New Drug Application, or NDA; however, there is no assurance
that the FDA will accept our Phase II program in lieu of a Phase III clinical trial. If the FDA
requires us to complete a Phase III clinical trial, the cost of development of arimoclomol for
treatment of ALS will increase significantly beyond our estimated costs, and the time to completion
of clinical testing also will be significantly delayed. In addition, the FDA ultimately could
require us to achieve an efficacy end point in the clinical trials for arimoclomol that could be
more difficult, expensive and time-consuming than our planned end point. Based upon the positive
results of recent preclinical studies in animals, we are considering possible clinical development
of arimoclomol in stroke patients. Arimoclomol has also shown therapeutic efficacy in a preclinical
animal model of diabetes, and we also may pursue development of arimoclomol for diabetic
indications. However, such development would require significant and costly additional testing.
There is no guarantee that arimoclomol will show any efficacy for any indication.
Iroxanadine has been tested in two Phase I clinical trials and one Phase II clinical trial
which indicated improvement in the function of endothelial cells in blood vessels of patients at
risk of cardiovascular disease. We might develop this product in indications such as diabetic
retinopathy and wound healing, which will require significant and costly additional testing. There
is no guarantee that iroxanadine will show any efficacy in the intended uses we are seeking. We may
also attempt to license iroxanadine to larger pharmaceutical or biotechnology companies for
cardiovascular indications; however, there is no guarantee that any such company will be interested
in licensing iroxanadine from us or licensing it on terms that are attractive to us.
Bimoclomol has been tested in two Phase II clinical trials where it was shown to be safe, but
where it did not show efficacy for diabetic neuropathy, the indication for which it was tested. We
may develop this compound for other therapeutic indications; however, there can be no guarantee
that this compound will be effective in treating any diseases. In addition, the FDA may require us
to perform new safety clinical trials, which would be expensive and time consuming and would delay
development of bimoclomol.
There is no guarantee that any additional clinical trials will be successful or that the FDA
will approve any of these products and allow us to begin selling them in the United States.
21
We Recently Identified Material Weaknesses in our Internal Control over Financial Reporting
In our most recent Annual Report on Form 10-K, we reported material weaknesses in the
effectiveness of our internal controls over financial reporting related to the application of
generally accepted accounting principles arising from our accounting for historical warrant
anti-dilution adjustments as deemed dividends, and in the effectiveness of our internal controls
over quarterly and annual financial statement reporting arising from our accounting for research
and development expenses related to our laboratory facility in Worcester, Massachusetts, which are
described in detail under the heading Controls and Procedures in our Form 10-K. Despite our
substantial efforts to ensure the integrity of our financial reporting process, we cannot guarantee
that we will not identify additional weaknesses as we continue to work with the new systems that we
have implemented over the past year. Any continuing material weaknesses in our internal control
over financial reporting could result in errors in our financial statements, which could erode
market confidence in our company, adversely affect the market price of our common stock and, in
egregious circumstances, result in possible claims based upon such financial information.
We Are Subject to Intense Competition, and There is No Assurance that We Can Compete Successfully
We and our strategic partners or licensees may be unable to compete successfully against our
current or future competitors. The pharmaceutical, biopharmaceutical and biotechnology industry is
characterized by intense competition and rapid and significant technological advancements. Many
companies, research institutions and universities are working in a number of areas similar to our
primary fields of interest to develop new products. There also is intense competition among
companies seeking to acquire products that already are being marketed. Many of the companies with
which we compete have or are likely to have substantially greater research and product development
capabilities and financial, technical, scientific, manufacturing, marketing, distribution and other
resources than at least some of our present or future strategic partners or licensees.
As a result, these competitors may:
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Succeed in developing competitive products sooner than us or our strategic partners or licensees. |
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Obtain FDA and other regulatory approvals for their products before we can obtain approval of any of our products. |
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Obtain patents that block or otherwise inhibit the development and commercialization of our product candidates. |
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Develop products that are safer or more effective than our products. |
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Devote greater resources to marketing or selling their products. |
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Introduce or adapt more quickly to new technologies and other scientific advances. |
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Introduce products that render our products obsolete. |
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Withstand price competition more successfully than us or our strategic partners or licensees. |
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Negotiate third-party strategic alliances or licensing arrangements more effectively. |
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Take advantage of other opportunities more readily. |
We are aware of only one drug, Rilutek, which was developed by Aventis Pharma AG, that has
been approved by the FDA for the treatment of ALS. Rilutek is now available in generic form. Other
companies are working to develop pharmaceuticals to treat ALS, including Aeolus Pharmaceuticals,
Celgene Corporation, Mitsubishi Pharma Corporation, Ono Pharmaceuticals, Trophos SA,
FaustPharmaceuticals SA, Oxford BioMedica plc, and Teva Pharmaceutical Industries Ltd. In addition,
ALS belongs to a family of diseases called neurodegenerative diseases, which includes Alzheimers,
Parkinsons and Huntingtons disease. Due to similarities between these diseases, a new treatment
for one ailment potentially could be useful for treating others.
There also are many companies that are producing and developing drugs used to treat
neurodegenerative diseases other than ALS, including Amgen, Inc., Cephalon, Inc., Ceregene, Inc.,
Elan Pharmaceuticals, plc, Forest Laboratories, Inc., H. Lundbeck A/S, Phytopharm plc, and Schwarz
Pharma AG.
22
A number of products currently are being marketed by a variety of the multinational or other
pharmaceutical companies for treating type 2 diabetes, including among others the diabetes drugs
Avandia by GlaxoSmithKline PLC, Actos by Eli Lilly & Co., Glucophage and Junavia by Bristol-Myers
Squibb Co., Symlin and Byetta by Amylin Pharmaceuticals, Inc. and Starlix by Novartis and the
obesity drugs Acomplia by Sanofi-Aventis SA, Xenical by F. Hoffman-La Roche Ltd. and Meridia by
Abbott Laboratories. Many major pharmaceutical companies are also seeking to develop new therapies
for these disease indications. Companies developing HIV vaccines that could compete with our HIV
vaccine technology include Merck, GlaxoSmithKline, Sanofi Pasteur, VaxGen, Inc., AlphaVax, Inc. and
Immunitor Corporation. These competitors have substantially greater research and product
development capabilities and financial, technical, scientific, manufacturing, marketing,
distribution and other resources than RXi.
We Will Rely upon Third Parties for the Manufacture of Our Clinical Product Supplies
We do not have the facilities or expertise to manufacture supplies of any of our product
candidates, including the clinical supply of arimoclomol used in our Phase II clinical trials.
Accordingly, we are dependent upon contract manufacturers or our strategic alliance partners to
manufacture these supplies. We have a manufacturing supply arrangement in place with respect to the
clinical supplies for the Phase II clinical program for arimoclomol for ALS. We have no
manufacturing supply arrangements for any of our other product candidates, and there can be no
assurance that we will be able to secure needed manufacturing supply arrangements on attractive
terms, or at all. Our failure to secure these arrangements as needed could have a materially
adverse effect on our ability to complete the development of our products or to commercialize them.
We May Be Unable to Protect Our Intellectual Property Rights, Which Could Adversely Affect the
Value of Our Assets
We believe that obtaining and maintaining patent and other intellectual property rights for
our technologies and potential products is critical to establishing and maintaining the value of
our assets and our business. Although we have patents and patent applications directed to our
molecular chaperone co-induction technologies, there can be no assurance that these patents and
applications will prevent third parties from developing or commercializing similar or identical
technologies, that the validity of our patents will be upheld if challenged by third parties or
that our technologies will not be deemed to infringe the intellectual property rights of third
parties. In particular, although we conducted certain due diligence regarding the patents and
patent applications related to our molecular chaperone co-induction drug candidates, and received
certain representations and warranties from the seller in connection with the acquisition, the
patents and patent applications related to our molecular chaperone co-induction drug candidates
were issued or filed, as applicable, prior to our acquisition and thus there can be no assurance
that the validity, enforceability and ownership of those patents and patent applications will be
upheld if challenged by third parties.
Any litigation brought by us to protect our intellectual property rights or by third parties
asserting intellectual property rights against us, or challenging our patents, could be costly and
have a material adverse effect on our operating results or financial condition, make it more
difficult for us to enter into strategic alliances with third parties to develop our products, or
discourage our existing licensees from continuing their development work on our potential products.
If our patent coverage is insufficient to prevent third parties from developing or commercializing
similar or identical technologies, the value of our assets is likely to be materially and adversely
affected.
We Are Subject to Potential Liabilities From Clinical Testing and Future Product Liability Claims
If any of our products are alleged to be defective, they may expose us to claims for personal
injury by patients in clinical trials of our products or by patients using our commercially
marketed products. Even if the commercialization of one or more of our products is approved by the
FDA, users may claim that such products caused unintended adverse effects. We currently do not
carry product liability insurance covering the commercial marketing of these products. We obtained
clinical trial insurance for our Phase IIa clinical trial of arimoclomol for the treatment of ALS,
and will seek to obtain similar insurance for the planned Phase IIb clinical trial of arimoclomol
and any other clinical trials that we conduct, as well as liability insurance for any products that
we market. There can be no assurance that we will be able to obtain additional insurance in the
amounts we seek, or at all. We anticipate that our licensees who are developing our products will
carry liability insurance covering the clinical testing and marketing of those products. There is
no assurance, however, that any insurance maintained by us or our licensees will prove adequate in
the event of a claim against us. Even if claims asserted against us are unsuccessful, they may
divert managements attention from our operations and we may have to incur substantial costs to
defend such claims.
23
We May Be Unable to Acquire Products Approved For Marketing
In the future, we may seek to acquire products from third parties that already are being
marketed or have been approved for marketing. We have not identified any of these products, and we
do not have any prior experience in acquiring or marketing products and may need to find third
parties to market any products that we might acquire. We may also seek to acquire products through
a merger with one or more companies that own such products. In any such merger, the owners of our
merger partner could be issued or hold a substantial, or even controlling, amount of stock in our
company or, in the event that the other company is the surviving company, in that other company.
Risks Associated With Our Ownership of RXi
The value of our ownership interest in RXi will depend upon RXis success in developing and
commercializing products based upon its RNAi technologies, which is subject to significant risks
and uncertainties, including the following:
RXi is Subject to Risks of a New Business
RXi is a start-up company with no operating history. RXi is initially focused solely on
developing and commercializing therapeutic products based upon its RNAi technologies, and there is
no assurance that RXi will be able to successfully implement its business plan. While RXis
management collectively possesses substantial business experience, including experience in taking
start-up companies from early stage to an operational stage, there is no assurance that they will
be able to manage RXis business effectively, or that they will be able to identify, hire and
retain any needed additional management or scientific personnel, to develop and implement RXis
product development plans, obtain third-party contracts or any needed financing, or achieve the
other components of RXis business plan.
The Approach RXi is Taking to Discover and Develop Novel Therapeutics Using RNAi is Unproven and
May Never Lead to Marketable Products
The RNAi technologies that RXi has licensed from UMMS have not yet been clinically tested by
CytRx or RXi, nor are we aware of any clinical trials having been completed by third parties
involving similar technologies. The scientific discoveries that form the basis for RXis efforts
to discover and develop new drugs are relatively new. The scientific evidence to support the
feasibility of developing drugs based on these discoveries is both preliminary and limited, and no
company has received regulatory approval to market therapeutics utilizing RNAi. Successful
development of RNAi-based products by RXi will require solving a number of issues, including
providing suitable methods of stabilizing the RNAi drug material and delivering it into target
cells in the human body. RXi may expend large amounts of money trying to solve these issues, and
never succeed in doing so. In addition, any compounds that RXi develops may not demonstrate in
patients the chemical and pharmacological properties ascribed to them in laboratory studies, and
they may interact with human biological systems in unforeseen, ineffective or even harmful ways.
RXi May Be Unable to Protect Its Intellectual Property Rights Licensed From UMMS or May Need to
License Additional Intellectual Property from Others.
The assets we contributed to RXi include a non-exclusive license to the fundamental Fire and
Mello patent owned by UMMS and the Carnegie Institution of Washington, which claims various aspects
of gene silencing, or genetic inhibition by double-stranded RNA. There can be no assurance that
this patent or other pending applications or issued patents belonging to its patent family would
withstand possible legal challenges or that it will effectively insulate the covered technologies
from competition. Therapeutic applications of gene silencing technology and other technologies that
RXi licenses from UMMS are also claimed in a number of UMMS pending patent applications, but there
can be no assurance that these applications will result in any issued patents or that any such
issued patents would withstand possible legal challenges or insulate RXis technologies from
competition. We are aware of a number of third party-issued patents directed to various particular
forms and compositions of RNAi-mediating molecules, and therapeutic methods using them, that RXi
will not use. Third parties may, however, hold or seek to obtain additional patents that could make
it more difficult or impossible for RXi to develop products based on the gene silencing technology
that RXi has licensed.
RXi has entered into an invention disclosure agreement with UMMS under which UMMS has agreed
to disclose to RXi certain inventions it makes and give RXi the exclusive right to negotiate
licenses to the disclosed inventions. There can be no assurance, however, that any such inventions
will arise, that RXi will be able to negotiate licenses to any inventions on satisfactory terms, or
at all, or that any negotiated licenses will prove commercially successful.
24
RXi may need to license additional intellectual property rights from third parties in order to
be able to complete the development or enhance the efficacy of its product candidates or avoid
possible infringement of the rights of others. There is no assurance that RXi will be able to
acquire any additional intellectual property rights on satisfactory terms, or at all.
We Are Required To Dispose of Some of Our RXi Shares, and May Not Be Able To Do So Promptly
Through the Issuance of a Dividend
We have agreed under our letter agreement with UMMS and our separate stockholders agreement
with RXi and its other current stockholders to reduce our share of ownership of RXi to less than a
majority of the outstanding voting power as soon as reasonably practicable. In order to do so, we
intend to make a dividend of a portion of our RXi shares to our stockholders. Any future dividend
to our stockholders of RXi shares would be subject to the approval of our board of directors and to
compliance with SEC rules and the requirements of the Delaware General Corporation Law, and there
is no assurance as to the timing or amount of such dividend. We may be unable to comply with these
rules and requirements, or may experience delays in complying. Any such dividend may be taxable to
our stockholders.
RXi May Not Be Able to Obtain Future Financing
On April 30, 2007, we provided to RXi $15.0 million, net of approximately $2.0 million of
expenses reimbursed to us by RXi, to satisfy the initial funding requirements under its agreements
with UMMS. We believe this initial funding will be sufficient to fund RXis planned business and
operations into the third quarter of 2008. It is possible, however, that RXi could require
additional funding prior to this time. RXi also will require substantial additional financing in
the future in connection with its RNAi research and development activities and any
commercialization of its products. We contributed all of our RNAi-related technologies to RXi in
order to accelerate the development and commercialization of drugs based upon these and RXis other
RNAi technologies. Although we believe that this will facilitate obtaining additional financing to
pursue RXis RNAi development efforts, RXi has no commitments or arrangements for any financing,
and there is no assurance that it will be able to obtain any future financing.
We May Not be Able to Exercise Our RXi Preemptive Rights
Under our agreement with RXi and its other current stockholders, with some exceptions, once we
no longer own a majority of RXis outstanding shares CytRx will have preemptive rights to acquire a
portion of any new securities sold or issued by RXi so as to maintain our percentage ownership of
RXi. Depending upon the terms and provisions of any proposed sale of new securities by RXi, we may
be unable or unwilling to exercise our preemptive rights, in which event our percentage ownership
of RXi will be diluted. In order to maintain our percentage ownership of RXi, we may need to obtain
our own financing, which may or may not be available to us on satisfactory terms, or at all.
RXi Retains Discretion Over Its Use of Any Funds That We Provide To It
Although RXi currently is a majority-owned subsidiary of ours, we do not control its
day-to-day operations. Accordingly, all funds received by RXi, including funds provided by us, may
be used by RXi in any manner its management deems appropriate, for its own purposes, including the
payment of salaries and expenses of its officers and other employees, amounts called for under the
UMMS licenses and invention disclosure agreement, and for other costs and expenses of its RNAi
research and development activities.
We Do Not Control RXi, And The Officers, Directors and Other RXi Stockholders May Have Interests
That Are Different From Ours
We have entered into a letter agreement with UMMS and a separate agreement with RXi and its
other current stockholders under which we agree during the term of RXis new licenses from UMMS to
vote our shares of RXi common stock for the election of directors of RXi and to take other actions
to ensure that a majority of the RXi board of directors are independent of us. We also have agreed
that we will reduce our ownership to less than a majority as soon as reasonably practicable. At any
time at which we own less than a majority of the voting power RXi, we will not be able to determine
the outcome of matters submitted to a vote of RXi stockholders. The other stockholders of RXi also
may have interests that are different from ours. Accordingly, RXi may engage in actions or develop
its business and operations in a manner that we believe are not in our best interests.
25
Products Developed by RXi Could Eventually Compete With Our Products For ALS, Type 2 Diabetes and
Obesity and Other Disease Indications
RXi has determined to focus its initial efforts on developing an RNAi therapeutics for the
treatment of a specific form of ALS caused by a defect in the SOD1 gene. Although arimoclomol is
being developed by CytRx for all forms of ALS, it is possible that any products developed by RXi
for the treatment of ALS could compete with any ALS products that CytRx may develop. RXi also plans
to pursue the development of RNAi therapeutics for the treatment of obesity and type 2 diabetes,
which could compete with any products that CytRx may develop for the treatment of these diseases.
The potential commercial success of any products that CytRx may develop for these and other
diseases may be adversely effected by competing products that RXi may develop.
RXi Will Be Subject to Competition, and It May Not Be Able To Compete Successfully
A number of medical institutions and pharmaceutical companies are seeking to develop products
based on gene silencing technologies. Companies working in this area include Alnylam
Pharmaceuticals, Sirna Therapeutics (which was recently acquired by Merck), Acuity Pharmaceuticals,
Nastech Pharmaceutical Company Inc., Nucleonics, Inc., Tacere Therapeutics Inc. and Benitec Ltd.
and a number of the multinational pharmaceutical companies. These competitors have substantially
greater research and development capabilities and financial, scientific, technical, manufacturing,
marketing, distribution, and other resources than RXi, and RXi may not be able to compete
successfully.
Risks Associated with Our Common Stock
Our Anti-Takeover Provisions May Make It More Difficult to Change Our Management or May
Discourage Others From Acquiring Us and Thereby Adversely Affect Stockholder Value
We have a stockholder rights plan and provisions in our bylaws that may discourage or prevent
a person or group from acquiring us without the participation and approval of our board of
directors. We recently extended the stockholder rights plan through April 2017.
We have a classified board of directors, which means that at least two stockholder meetings,
instead of one, will be required to effect a change in the majority control of our board of
directors. This provision applies to every election of directors, not just an election occurring
after a change in control. The classification of our board increases the amount of time it takes to
change majority control of our board of directors and may cause our potential purchasers to lose
interest in the potential purchase of us, regardless of whether our purchase would be beneficial to
us or our stockholders. The additional time and cost to change a majority of the members of our
board of directors makes it more difficult and may discourage our existing stockholders from
seeking to change our existing management in order to change the strategic direction or operational
performance of our company.
Our bylaws provide that directors may only be removed for cause by the affirmative vote of the
holders of at least a majority of the outstanding shares of our capital stock then entitled to vote
at an election of directors. This provision prevents stockholders from removing any incumbent
director without cause. Our bylaws also provide that a stockholder must give us at least 120 days
notice of a proposal or director nomination that such stockholder desires to present at any annual
meeting or special meeting of stockholders. Such provision prevents a stockholder from making a
proposal or director nomination at a stockholder meeting without us having advance notice of that
proposal or director nomination. This could make a change in control more difficult by providing
our directors with more time to prepare an opposition to a proposed change in control. By making it
more difficult to remove or install new directors, the bylaw provisions may also make our existing
management less responsive to the views of our stockholders with respect to our operations and
other issues such as management selection and management compensation.
Our Outstanding Options and Warrants and the Availability for Resale of Our Shares Issued in Our
Private Financings May Adversely Affect the Trading Price of Our Common Stock
As
of April 30, 2007, there were outstanding stock options and warrants to purchase approximately
22.4 million shares of our common stock at a weighted-average exercise price of $1.87 per share.
Our outstanding options and warrants could adversely affect our ability to obtain future financing
or engage in certain mergers or other transactions, since the holders of options and warrants can
be expected to exercise them at a time when we may be able to obtain additional capital through a
new offering of securities on terms more favorable to us than the terms of outstanding options and
warrants. For the life of the options and warrants, the holders have the opportunity to profit from
a rise in the market price of our common stock without assuming the risk of ownership. To the
extent the
26
trading price of our common stock at the time of exercise of any such options or warrants
exceeds the exercise price, such exercise will also have a dilutive effect on our stockholders.
Many of our outstanding warrants contain anti-dilution provisions pertaining to dividends or
distributions with respect to our common stock that could be triggered upon our intended dividend
or distribution of RXi shares. Our outstanding warrants to purchase approximately 1.4 million
shares also contain anti-dilution provisions that are triggered upon any issuance of securities by
us below the prevailing market price of our common stock. In the event that these anti-dilution
provisions are triggered by us in the future, we would be required to reduce the exercise price,
and increase the number of shares underlying, those warrants, which would have a dilutive effect on
our stockholders.
As of May 4, 2007, we had registered with the SEC for resale by our stockholders a total of
approximately 59.9 million outstanding shares of our common stock, and approximately 22.4 million
additional shares of our common stock issuable upon exercise of outstanding options and warrants.
The availability of these shares for public resale, as well as actual resales of these shares,
could adversely affect the trading price of our common stock.
We May Issue Preferred Stock in the Future, and the Terms of the Preferred Stock May Reduce the
Value of Our Common Stock
We are authorized to issue up to 5,000,000 shares of preferred stock in one or more series.
Our board of directors may determine the terms of future preferred stock offerings without further
action by our stockholders. If we issue preferred stock, it could affect your rights or reduce the
value of our outstanding common stock. In particular, specific rights granted to future holders of
preferred stock may include voting rights, preferences as to dividends and liquidation, conversion
and redemption rights, sinking fund provisions, and restrictions on our ability to merge with or
sell our assets to a third party.
We May Experience Volatility in Our Stock Price, Which May Adversely Affect the Trading Price of
Our Common Stock
The market price of our common stock has ranged from $0.87 to $5.49 per share during the
52-week period ended April 30, 2007, and may continue to experience significant volatility from
time to time. Factors such as the following may affect such volatility:
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Announcements of regulatory developments or technological innovations by us or our competitors. |
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Changes in our relationship with our licensors and other strategic partners=. |
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Changes in our ownership or other relationships with RXi. |
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Our quarterly operating results. |
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Developments in patent or other technology ownership rights. |
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Public concern regarding the safety of our products. |
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Government regulation of drug pricing. |
Other factors which may affect our stock price are general changes in the economy, the
financial markets or the pharmaceutical or biotechnology industries.
Item 6. Exhibits
The exhibits listed in the accompanying Index to Exhibits are filed as part of this Quarterly
Report on Form 10-Q and incorporated herein by reference.
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SIGNATURES
Pursuant to the requirements 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.
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CYTRX CORPORATION
(Registrant)
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Date: May 10, 2007 |
By: |
/s/ MATTHEW NATALIZIO
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Matthew Natalizio |
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Chief Financial Officer
(Principal Financial Officer) |
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INDEX TO EXHIBITS
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Exhibit |
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Number |
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Description |
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4.1 (a)
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Amendment No. 2 to Shareholder Protection Rights Agreement |
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10.1
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Contribution Agreement, dated as of January 8, 2007, between CytRx Corporation and RXi Pharmaceuticals
Corporation |
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10.2
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Reimbursement Agreement, dated January 8, 2007, between CytRx Corporation and RXi Pharmaceuticals Corporation |
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10.3
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Exclusive License Agreement (UMASS Agreement No UMMC 03-75-01), effective as of January 10, 2007, between
RXi Pharmaceuticals Corporation and the University of Massachusetts |
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10.4
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Non-Exclusive License Agreement (UMASS Agreement No. UMMC 06-08-03), effective as of January 10, 2007,
between RXi Pharmaceuticals Corporation and the University of Massachusetts |
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10.5
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Exclusive License Agreement (UMASS Agreement No. UMMC 06-21-01), effective as of January 10, 2007, between
RXi Pharmaceuticals Corporation and the University of Massachusetts |
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10.6
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Exclusive License Agreement (UMASS Agreement No. UMMC 03-68-02), effective as of January 10, 2007, between
RXi Pharmaceuticals Corporation and the University of Massachusetts |
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10.7
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Invention Disclosure Agreement (UMASS Agreement No. UMMC 07-U-200), effective as of the Effective Date (as
defined), between RXi Pharmaceuticals Corporation and the University of Massachusetts |
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10.8
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Voting agreement, dated as of January 10, 2007, between CytRx Corporation and the University of Massachusetts |
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10.9
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Master Agreement for Clinical Trials Management Services, dated February 5, 2007, between CytRx Corporation
and Pharmaceutical Research Associates |
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10.10 *
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Employment Agreement dated February 22, 2007, by and among Dr. Tod Woolf, CytRx Corporation and RXi
Pharmaceuticals Corporation |
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10.11
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Stockholders agreement, dated February 23, 2007, among CytRx Corporation, RXi Pharmaceuticals Corporation,
Craig C. Mello, Ph.D., Tariq Rana, Ph.D., Gregory J. Hannon, Ph.D., and Michael P. Czech, Ph.D |
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10.12 (b)
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Form of Purchase Agreement, dated as of April 17, 2007, by and between CytRx Corporation and each of the
selling stockholders named in the prospectus made part of this registration statement |
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10.13
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Contribution Agreement, dated as of April 30, 2007, between CytRx Corporation and RXi Pharmaceuticals
Corporation |
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31.1
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Certification of Chief Executive Officer Pursuant to 15 U.S.C. Section 7241, as adopted pursuant to Section
302 of the Sarbanes-Oxley Act of 2002 |
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31.2
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Certification of Chief Financial Officer Pursuant to Section 15 U.S.C. Section 7241, as adopted pursuant to
Section 302 of the Sarbanes Oxley Act of 2002 |
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32.1
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Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002 |
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32.2
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Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002 |
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* |
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Indicates a management contract or compensatory plan or arrangement. |
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Confidential treatment has been requested or granted for certain portions which have been
blanked out in the copy of the exhibit filed with the Securities and Exchange Commission. The
omitted information has been filed separately with the Securities and Exchange Commission. |
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(a) |
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Incorporated by reference to the Corporations Annual Report on Form 10-K filed on April 2,
2007. |
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(b) |
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Incorporated by reference to the Corporations current report on Form 8-K filed on April 18,
2007. |
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