e10vq
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 June 30, 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
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58-1642740 |
(State or other jurisdiction
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(I.R.S. Employer Identification No.) |
of incorporation or organization) |
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11726 San Vicente Blvd. |
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Suite 650 |
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Los Angeles, CA
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90049 |
(Address of principal executive offices)
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(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.
Large accelerated filer
o Accelerated filer þ 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, $.001 par value, issued and outstanding as of
August 7, 2007: 88,143,477, exclusive of treasury shares.
CYTRX CORPORATION
Form 10-Q
Table of Contents
2
Part I FINANCIAL INFORMATION
Item 1. Financial Statements
CYTRX CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
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June 30, |
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December 31, |
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2007 |
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2006 |
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(Unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
69,697,571 |
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$ |
30,381,393 |
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Accounts receivable |
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1,500,000 |
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105,930 |
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Prepaid expense and other current assets |
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666,334 |
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233,323 |
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Total current assets |
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71,863,905 |
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30,720,646 |
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Equipment and furnishings, net |
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214,715 |
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252,719 |
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Molecular library, net |
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238,703 |
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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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172,418 |
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195,835 |
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Total assets |
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$ |
72,673,521 |
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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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$ |
1,904,002 |
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$ |
955,156 |
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Accrued expenses and other current liabilities |
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2,732,869 |
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2,722,478 |
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Deferred revenue, current portion |
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7,329,548 |
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6,733,350 |
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Total current liabilities |
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11,966,419 |
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10,410,984 |
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Deferred revenue, non-current portion |
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11,662,413 |
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16,075,117 |
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Total liabilities |
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23,628,832 |
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26,486,101 |
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Commitment and Contingencies |
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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, $.001 par value, 125,000,000
shares authorized; 88,574,000 and 70,789,000
shares issued at June 30, 2007 and December 31,
2006, respectively |
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88,574 |
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70,789 |
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Additional paid-in capital |
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201,620,189 |
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146,961,657 |
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Treasury stock, at cost (633,816 shares held
at June 30, 2007 and December 31, 2006,
respectively) |
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(2,279,238 |
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(2,279,238 |
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Accumulated deficit |
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(150,384,836 |
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(139,602,869 |
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Total stockholders equity |
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49,044,689 |
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5,150,339 |
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Total liabilities and stockholders equity |
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$ |
72,673,521 |
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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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Six Months Ended |
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June 30, |
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June 30, |
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2007 |
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2006 |
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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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$ |
2,369,513 |
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$ |
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$ |
3,816,506 |
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$ |
60,830 |
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Grant revenue |
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116,070 |
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Other revenue |
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1,000 |
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1,000 |
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2,370,513 |
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3,933,576 |
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60,830 |
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Expenses: |
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Research and development (includes
non-cash expense as follows: $144,000
and $77,000 of employee stock-based
compensation expense for the three
months ended June 30, 2007 and 2006,
respectively, $181,000 and $160,000 of
employee stock-based compensation
expense for the six months ended June
30, 2007 and 2006 respectively; $339,000
and $61,000 of non-employee stock-based
compensation for the three months ended
June 30, 2007 and 2006, respectively;
$1,058,000 and $105,000 of non-employee
stock-based compensation for the six
months ended June 30, 2007 and 2006,
respectively, and an aggregate 462,112
shares of RXi common stock valued at
$2,311,560 issued in exchange for
licensing rights) |
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6,266,316 |
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3,205,372 |
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9,883,207 |
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5,517,383 |
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General and administrative (includes
non-cash expense as follows: $599,000 and $274,000 of employee
stock-based compensation for the three
months ended June 30, 2007 and 2006,
respectively, and $710,000 and $536,000
of employee stock-based compensation
expense for the six months ended June
30, 2007 and 2006, respectively, and $0
and $58,000 of non-employee stock-based compensation for the three months ended
June 30, 2007 and 2006, respectively,
and $0 and $126,000 of non-employee
stock-based compensation for the six
months ended June 30, 2007 and 2006,
respectively) |
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4,497,444 |
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2,436,916 |
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7,374,012 |
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4,459,582 |
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10,763,760 |
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5,642,288 |
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17,257,219 |
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9,976,965 |
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Loss before other income |
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(8,393,247 |
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(5,642,288 |
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(13,323,643 |
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(9,916,135 |
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Other income: |
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Interest and dividend income |
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659,062 |
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176,908 |
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1,039,676 |
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284,398 |
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Other income |
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1,500,000 |
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1,500,000 |
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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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(6,234,185 |
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(5,465,380 |
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(10,781,967 |
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(9,631,737 |
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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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$ |
(6,234,185 |
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$ |
(5,465,380 |
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$ |
(10,781,967 |
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$ |
(10,120,166 |
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Basic and diluted loss per common share |
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$ |
(0.07 |
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$ |
(0.08 |
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$ |
(0.14 |
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$ |
(0.15 |
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Weighted average shares outstanding |
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85,379,769 |
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69,977,876 |
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79,242,321 |
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66,181,900 |
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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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Six Months Ended June 30, |
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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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$ |
(10,781,967 |
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$ |
(9,631,737 |
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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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121,067 |
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138,941 |
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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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583,045 |
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230,547 |
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Common stock in subsidiary issued in exchange for licenses |
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2,310,560 |
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Deferred revenue |
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(3,816,506 |
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Expense related to employee and non-employee stock options |
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1,622,874 |
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696,378 |
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Net change in operating assets and liabilities |
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(842,429 |
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788,796 |
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Total adjustments |
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(23,389 |
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1,854,662 |
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Net cash used in operating activities |
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(10,805,356 |
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(7,777,075 |
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Cash flows from investing activities: |
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Purchases of property and equipment |
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(38,303 |
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(22,335 |
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Net cash used in investing activities |
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(38,303 |
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(22,335 |
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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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15,909,775 |
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339,194 |
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Net proceeds from issuances of common stock |
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34,248,062 |
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12,404,360 |
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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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50,159,837 |
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12,743,554 |
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Net increase in cash and cash equivalents |
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39,316,178 |
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4,944,144 |
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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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$ |
69,697,571 |
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$ |
13,243,534 |
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Supplemental disclosure of cash flow information: |
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Cash received during the period for interest received |
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$ |
1,039,676 |
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$ |
248,398 |
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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 six months
ended June, 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
June 30, 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 amplification technology. The Company has completed a three-month Phase IIa
clinical trial and six-month open-label trial extension of that trial, for 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
efficacy trial of arimoclomol for this indication during the second half of 2007, subject to FDA
clearance. Based on preliminary discussions with the FDA, CytRx is now considering a second
efficacy clinical trial for ALS, possibly in parallel with the upcoming Phase IIb trial, to provide
additional efficacy data to support a possible approval decision by the FDA. 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 has announced plans to commence a Phase II clinical trial
for arimoclomol in stroke recovery in the first half of 2008, subject to FDA clearance. The Company
has also announced plans to commence a Phase II clinical trial with its next drug candidate,
iroxanadine, for diabetic foot ulcers in the first half of 2008, subject to FDA clearance. In
addition, subsequent to period end, the Company opened a research and development facility in San
Diego to provide it with a dedicated laboratory to accelerate its molecular chaperone drug
development programs.
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 its RNAi technologies, in January 2007, the Company transferred to RXi
Pharmaceuticals Corporation (RXi), 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 University of Massachusetts Medical School, or 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 contributed to RXi $15.0 million, net of expenses of approximately $2.0
million reimbursed to it by RXi, to satisfy certain initial funding requirements under its
agreements with UMMS. As a result of these transactions, CytRx owned as of June 30, 2007
approximately 86% of the outstanding capital stock of RXi. 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 do so, 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 and compliance with applicable Securities and Exchange Commission, or SEC, rules
and the requirements of the Delaware General Corporation Law. Any such dividend may be taxable to
CytRx, although any applicable taxes due may be off-set by the Companys net operating loss
carryforwards; however there is no assurance that the Companys current net operating loss
carryforwards will be sufficient to cover any such taxable event, and if they are not, then CytRx
might be required to pay income tax.
To date, the Company has relied primarily upon sales of its 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. See Note 5 Liquidity and Capital Resources.
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 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
6
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 June 30, 2007 and for the
three and six-month periods ended June 30, 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.
The financial statements included herein have been prepared by the Company pursuant to the
rules and regulations of the SEC. Certain information and footnote disclosures normally included in
financial statements prepared in accordance with accounting principles generally accepted in the
Untied States 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.
In June 2007, the FASB ratified the consensus on Emerging Issues Task Force (EITF) Issue No.
06-11, Accounting for Income Tax Benefits of Dividends on Share-Based Payment Awards (EITF
06-11). EITF 06-11 requires companies to recognize the income tax benefit realized from dividends
or dividend equivalents that are charged to retained earnings and paid to employees for non-vested
equity-classified employee share-based payment awards as an increase to additional paid-in capital.
EITF 06-11 is effective for fiscal years beginning after September 15, 2007 (fiscal year 2008 for
the Company). The adoption is not expected to have a material impact on the Companys consolidated
financial statements.
In June 2007, the FASB ratified the consensus reached on EITF Issue No. 07-3, Accounting for
Nonrefundable Advance Payments for Goods or Services Received for Use in Future Research and
Development Activities (EITF 07-3), which requires that nonrefundable advance payments for goods
or services that will be used or rendered for future research and development activities be
deferred and amortized over the period that the goods are delivered or the related services are
performed, subject to an assessment of recoverability. EITF 07-3 will be effective for fiscal years
beginning after December 15, 2007, which will be the Companys fiscal year 2008. The Company does
not expect that the adoption of EITF 07-3 will have an impact 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
7
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 20.4 million and 29.2 million shares at
June 30, 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 deemed dividend of
approximately $488,000. The deemed dividend is 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 loss per
shares.
4. Stock Based Compensation
CytRx Corporation
As of June 30, 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 6,294,000 shares subject to outstanding common stock options and approximately
1.9 million shares available
for future grant. Additionally, the Company has one other active plan, the 1998 Long Term Incentive
Plan, which includes approximately 86,000 shares subject to outstanding common stock options and
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 common 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 service period.
The Companys stock-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 stock-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 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).
Stock-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 (EITF 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 No. 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) and EITF 96-18,
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 common 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 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 common stock options are fully vested. The Company recognized
approximately $1,013,000 and $105,000 of stock based compensation expense related to non-employee
common stock options for the
8
six-month periods ended June 30, 2007 and 2006, respectively. Included in the amount
recognized in 2007 is an adjustment of approximately $303,000 related to options granted to
consultants in 2006.
During the first six months of 2007, the Company issued options to purchase 900,000 shares of
its common stock. The fair value of the common stock options granted
in the six month periods listed in the table below was estimated using the Black-Scholes option-pricing model, based on the
following assumptions:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
June 30, 2007 |
|
June 30, 2006 |
Risk-free interest rate |
|
|
4.43% - 4.78 |
% |
|
|
4.27% - 5.23 |
% |
Expected volatility |
|
|
108.9 |
% |
|
|
117.0 |
% |
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 six-month periods
ended June 30, 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 six-month periods ended June 30, 2007 and 2006, the Company has estimated an annualized
forfeiture rate of 15% and 10%, respectively, for options granted to
its employees and 3% for each period 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 $1,239,000 and
$696,000 of employee stock-based compensation for the six-month periods ended June 30, 2007 and
2006, respectively. No amounts relating to employee stock-based compensation have been capitalized.
Compensation costs will be adjusted for future changes in estimated forfeitures.
At June 30, 2007, there remained approximately $3.5 million of unrecognized compensation
expense related to unvested stock options granted to employees, directors, scientific advisory
board members and consultants, to be recognized as expense over a weighted-average period of 1.55
years. Presented below is the Companys stock option activity:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Options |
|
|
Six-Months Ended |
|
|
June 30, 2007 |
|
|
Number of Shares |
|
Number of Shares |
|
Total Number |
|
Weighted Average |
|
|
(Employees) |
|
(Non-Employees) |
|
of Shares |
|
Exercise Price |
Outstanding at January 1, 2007 |
|
|
4,150,000 |
|
|
|
2,708,000 |
|
|
|
6,858,000 |
|
|
$ |
1.66 |
|
Granted |
|
|
900,000 |
|
|
|
|
|
|
|
900,000 |
|
|
$ |
4.40 |
|
Exercised |
|
|
(596,000 |
) |
|
|
(136,000 |
) |
|
|
(732,000 |
) |
|
$ |
1.91 |
|
Forfeited |
|
|
(150,000 |
) |
|
|
(582,000 |
) |
|
|
(732,000 |
) |
|
$ |
1.73 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2007 |
|
|
4,304,000 |
|
|
|
1,990,000 |
|
|
|
6,294,000 |
|
|
$ |
2.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at June 30, 2007 |
|
|
2,642,000 |
|
|
|
1,740,000 |
|
|
|
4,382,000 |
|
|
$ |
1.76 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A summary of the activity for nonvested common stock options as of June 30, 2007 is presented
below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Number of Shares |
|
Number of Shares |
|
Total Number of |
|
Grant Date Fair |
|
|
(Employees) |
|
(Non-Employees) |
|
Shares |
|
Value per Share |
Nonvested at January 1, 2007 |
|
|
1,183,000 |
|
|
|
917,000 |
|
|
|
2,100,000 |
|
|
$ |
1.19 |
|
Granted |
|
|
900,000 |
|
|
|
|
|
|
|
900,000 |
|
|
$ |
3.70 |
|
Forfeited |
|
|
(150,000 |
) |
|
|
(582,000 |
) |
|
|
(732,000 |
) |
|
$ |
1.52 |
|
Vested |
|
|
(272,000 |
) |
|
|
(104,000 |
) |
|
|
(376,000 |
) |
|
$ |
1.57 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at June 30, 2007 |
|
|
1,661,000 |
|
|
|
250,000 |
|
|
|
1,911,000 |
|
|
$ |
2.21 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes significant ranges of outstanding common stock options under
the two plans at June 30, 2007:
9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
999,000 |
|
|
|
7.13 |
|
|
$ |
0.80 |
|
|
|
699,000 |
|
|
|
7.13 |
|
|
$ |
0.81 |
|
$1.01 2.00
|
|
|
3,057,000 |
|
|
|
7.48 |
|
|
|
1.53 |
|
|
|
2,309,000 |
|
|
|
7.48 |
|
|
|
1.24 |
|
$2.01 2.50
|
|
|
1,336,000 |
|
|
|
6.06 |
|
|
|
2.45 |
|
|
|
1,336,000 |
|
|
|
6.06 |
|
|
|
2.45 |
|
$2.51 3.00
|
|
|
2,000 |
|
|
|
1.95 |
|
|
|
2.63 |
|
|
|
2,000 |
|
|
|
1.95 |
|
|
|
2.63 |
|
$3.01 4.51
|
|
|
900,000 |
|
|
|
9.81 |
|
|
|
4.40 |
|
|
|
36,000 |
|
|
|
9.81 |
|
|
|
4.51 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,294,000 |
|
|
|
7.45 |
|
|
$ |
2.02 |
|
|
|
4,382,000 |
|
|
|
6.75 |
|
|
$ |
1.76 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate intrinsic value of outstanding options as of June 30, 2007 was $8.8 million, of
which $6.0 million was 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 June 30, 2007 ($3.12) and the exercise price of the underlying options. The intrinsic
value of options exercised was $847,000 for the six-month period ended June 30, 2007, and the
intrinsic value of options that vested was approximately $650,000 for
the same period.
RXi Pharmaceuticals
RXi is a majority owned subsidiary of CytRx and has its own stock option plan, named the RXi
Pharmaceuticals Corporation 2007 Incentive Plan. As of June 30, 2007, an aggregate of 1,902,000
shares of common stock were reserved for issuance under the RXi Pharmaceuticals Corporation 2007
Incentive Plan, including approximately 1,177,000 shares subject to outstanding common stock
options granted under this plan and approximately 725,000 shares available for future grant. The
administrator of the plan determines the times which an option may become exercisable. Vesting
periods of options granted to date include vesting upon grant to vesting at the end of a five year
period.
RXi which began its operations on January 8, 2006, adopted SFAS 123(R), Accounting for
Stock-based Compensation (Revised 2004), which requires the measurement and recognition of
compensation expense for all stock-based payment awards made to employees and non-employee
directors. In March 2005, the Securities and Exchange Commission issued SAB 107, Share-Based
Payment, relating to SFAS 123(R). RXi has applied the provisions of SAB 107 in its adoption of SFAS
123(R).
For common stock options paid in consideration of services rendered by non-employees, RXi
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 No. 123(R),
the compensation associated with common stock options paid to non-employees is generally recognized
in the period during which services are rendered by such non-employees. There have been no changes
to RXis 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 common 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 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 common stock options are fully vested. The Company used an
independent third-party valuation firm to estimate the fair market value of RXi and the fair market
value of RXi options. Based on those estimates, RXi recognized approximately $732,000 of stock
based compensation expense related to non-employee stock options for the six-month period ended
June 30, 2007.
During the first six months of 2007, the Company issued options to purchase 829,000 shares of
its common stock. The fair value of the common stock options granted in the six month period
listed in the table below was estimated using the Black-Scholes option-pricing model, based on the
following assumptions:
|
|
|
|
|
|
|
Six-Months Ended |
|
|
June 30, 2007 |
Risk-free interest rate |
|
|
4.43% - 4.78 |
% |
Expected volatility |
|
|
1.1% - 1.9 |
% |
Expected lives (years) |
|
|
6 |
|
Expected dividend yield |
|
|
0.00 |
% |
The
fair value of RXis common stock and RXis expected common stock price volatility assumption is based upon an independent
third-party valuation that determined the RXi corporate valuation and
analyzed the volatility of a basket of comparable companies. The
expected life assumptions were based upon the simplified method provided for under SAB 107, which
averages the contractual term of RXis 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
that RXi has never paid cash dividends and presently has no intention of paying cash dividends. The
risk-free interest rate used for each grant was also based upon prevailing
10
short-term interest
rates. Based on CytRxs historical experience, for the six-month period ended June 30, 2007, RXi
has estimated an annualized forfeiture rate of 15% for options granted to its employees, 8% for
options granted to senior management and no forfeiture rate for the directors. RXi 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), RXi recorded $329,000 of employee stock-based compensation for the six-month period ended
June 30, 2007. No amounts relating to employee stock-based compensation have been capitalized. As
of June 30, 2007, there was $2,700,000 of unrecognized compensation cost related to outstanding
options that is expected to be recognized as a component of RXis operating expenses through 2009.
Compensation costs will be adjusted for future changes in estimated forfeitures.
At June 30, 2007, the unrecognized compensation expense related to unvested common stock
options granted to employees, directors, scientific advisory board members and consultants is
expected to be recognized as expense over a weighted-average period of 1.78 years. Presented below
is RXis common stock option activity:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Options |
|
|
Six-Months Ended |
|
|
June 30, 2007 |
|
|
Number of Shares |
|
Number of Shares |
|
Total Number |
|
Weighted Average |
|
|
(Employees) |
|
(Non-Employees) |
|
of Shares |
|
Exercise Price |
Outstanding at January 1, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
829,000 |
|
|
|
348,000 |
|
|
|
1,177,000 |
|
|
$ |
5.00 |
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2007 |
|
|
829,000 |
|
|
|
348,000 |
|
|
|
1,177,000 |
|
|
$ |
5.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at June 30, 2007 |
|
|
98,000 |
|
|
|
215,000 |
|
|
|
313,000 |
|
|
$ |
5.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A summary of the activity for nonvested stock options as of June 30, 2007 is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Number of Shares |
|
Number of Shares |
|
Total Number of |
|
Grant Date Fair |
|
|
(Employees) |
|
(Non-Employees) |
|
Shares |
|
Value per Share |
Nonvested at January 1, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
829,000 |
|
|
|
348,000 |
|
|
|
1,177,000 |
|
|
$ |
5.00 |
|
Forfeited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested |
|
|
(97,000 |
) |
|
|
(216,000 |
) |
|
|
(313,000 |
) |
|
$ |
5.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at June 30, 2007 |
|
|
732,000 |
|
|
|
132,000 |
|
|
|
864,000 |
|
|
$ |
5.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes significant ranges of outstanding common stock options under
the plan at June 30, 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 |
$5.00
|
|
|
1,177,000 |
|
|
|
9.87 |
|
|
$ |
5.00 |
|
|
|
313,000 |
|
|
|
9.88 |
|
|
$ |
5.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate intrinsic value of outstanding options as of June 30, 2007 is negligible. The
aggregate intrinsic value is calculated based on the positive difference between the closing fair
market value of RXis common stock on June 30, 2007 and the exercise price of the underlying
options.
5. Liquidity and Capital Resources
At June 30, 2007, the Company had cash and cash equivalents of $69.7 million, including $19.2
million that it received from the sale of 8.6 million shares at $4.30 per share 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. That belief is based in part on
projected expenditures through the remainder of 2007 and the first
half of 2008 of $24.5 million,
including $7.3 million for the Companys Phase IIb trial of arimoclomol for ALS and related studies
and $10.8 million for its other clinical programs, including a planned Phase II clinical trial of
arimoclomol in stroke patients and a planned Phase II clinical trial of iroxanadine for diabetic
foot ulcers (which the Company estimates will, through completion, cost $10.0 million and $5.6 million,
respectively). Management estimates that RXi separately will expend
approximately $8.2 million on development activities through the remainder of 2007 and the first half of 2008.
Managements estimate regarding the
11
Companys financial resources assumes that no second efficacy
trial will be required for arimoclomol for ALS. If the Company undertakes an additional efficacy
trial, its actual expenses will be materially greater than currently estimated. 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 10.6 million shares of its common stock and warrants to purchase an additional 5.3 million
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 that 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 cash penalties, up to a maximum of 16% (approximately $2.1
million) of the purchase price paid for the securities in the event that the Company failed 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 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 probable to occur, and thus no amount need be accrued.
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. Following that transaction, CytRx owned as of June 30, 2007 approximately 86%
of the outstanding capital stock of RXi.
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. For the reasons described above, the Company accounted for the anti-dilution
adjustments as deemed dividends. 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 cash penalties, up to a maximum of 16% (approximately $5.9
million) of the purchase price paid for the securities in the event that the Company failed 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
12
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.
During the three-month period ended June 30, 2007, the Company issued 2.6 million shares of
its common stock, and received $4.8 million, upon the exercise of stock options and warrants.
During the second quarter of 2007, the Company granted stock options covering 900,000 shares.
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 stock options.
During the second quarter of 2007, the Companys RXi subsidiary issued approximately 462,000
shares of its common stock in connection with its UMMS licensing agreements. The shares were
valued at $2.3 million which was recorded as a charge to research and development expense.
Additionally, RXi granted stock options to purchase 1,177,000 shares of RXi common stock at an
exercise price of $5.00 per share to certain officers, employees, directors and scientific advisory
board members. RXi did not issue any shares of common stock in connection with license agreements,
or grant any stock options, during the first quarter of 2007.
7. Other Income
In June 2007,
we recognized $1.5 million of income arising from a fee received
pursuant to a change-in-control provision
included in the purchase agreement for our 1998 sale of our animal
pharmaceutical unit. Management concluded that the fee did not
represent revenue generated from our normal course of our business,
and accordingly we recorded this fee as other income.
8. Subsequent Events
On July 20, 2007, the Company entered into a lease, as part of its previously announced
relocation of its laboratory facility to San Diego, California. Under the terms of the lease, CytRx
will occupy approximately 10,000 square feet of office and laboratory space. The lease is for a
term of three years expiring on July 31, 2010, unless earlier terminated in accordance with the
lease.
As of July 31, 2007, the Company had received approximately $482,000 in connection with the
exercise of warrants and options since June 30, 2007.
In July 2007, the Company amended its Restated Certificate of Incorporation to increase the
authorized number of shares of its common stock from 125,000,000 to 150,000,000 shares.
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 statements in this section, 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
13
of
terminology such as may, will, expects, plans, anticipates, estimates, potential or
could or the negative thereof or other comparable terminology. 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 amplification
technology. We have completed a three-month Phase IIa clinical trial of our lead small molecule
product candidate, arimoclomol, and a six-month open-label extension of that 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. We plan to initiate a Phase
IIb efficacy trial of arimoclomol for this indication during the second half of 2007, subject to
FDA clearance. Based on preliminary discussions with the FDA, we are now considering a second
efficacy clinical trial for ALS, possibly in parallel with the upcoming Phase IIb trial, to provide
additional efficacy data to support a possible approval decision by the FDA. 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 have announced plans to commence a Phase II clinical trial for
arimoclomol in stroke recovery in the first half of 2008, subject to FDA clearance. We have also
announced plans to commence a Phase II clinical trial with our next drug candidate, iroxanadine,
for diabetic foot ulcers in the first half of 2008, subject to FDA clearance. In addition, we
recently opened a research and development facility in San Diego to provide us with a dedicated
laboratory to accelerate our molecular chaperone drug development programs.
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
University of Massachusetts Medical School, or 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 sales of our 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 June
30, 2007, we had cash and cash equivalents of $69.7 million, including $19.2 million that we
received from the sale of shares in our 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.
Management believes that we have adequate financial resources to support our currently planned
level of
operations into the second half of 2009. That belief is based in part on projected
expenditures through the remainder of 2007 and the first half of 2008
of $24.5 million, including
$7.3 million for our Phase IIb trial of arimoclomol for ALS and related studies and $10.8 million
for our other clinical programs, including a planned Phase II clinical trial of arimoclomol in
stroke patients and a planned Phase II clinical trial of iroxanadine for diabetic foot ulcers
(which we estimate will, through completion, cost $10.0 million and $5.6 million, respectively).
Management estimates that RXi separately will expend approximately
$8.2 million on development
activities through the remainder of 2007 and the first half of 2008. Managements estimate
regarding our financial resources assumes that no second efficacy trial will be required for
arimoclomol for ALS. If we undertake an additional efficacy trial, our actual expenses will be
materially greater than currently estimated. We will be required to obtain additional funding in
order to execute our long-term
14
business plans, although we do not currently have commitments from
any third parties to provide us with capital. We cannot assure that additional funding will be
available on favorable terms, or at all. If we fail to obtain additional funding when needed, we
may not be able to execute our business plans and our business may suffer, which would have a
material adverse effect on our financial position, results of operations and cash flows.
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 us, although any applicable taxes due may
be off-set by our net operating loss carryforwards; however there is no assurance that our current
net operating loss carryforwards will be sufficient to cover any such taxable event, and if they
are not, then CytRx might be required to pay income tax.
RXi began operating as a stand-alone company with its own management, business, and operations
in January 2007. 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 $6.5 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, 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 consist of license fees from strategic alliances from
pharmaceutical companies as well as service revenues. Service revenues consist of contract research
and laboratory consulting. Grant revenues consist of 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.
15
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 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. As of December 31, 2006, we recognized approximately $1.8 million of service
revenue related to this transaction. For three and six-months ended June 30, 2007, we recognized
approximately $2.4 and $3.8 million, respectively, in service revenue. 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.
The amount of deferred revenue, current portion is the amount of deferred revenue that is
expected to be recognized in the next twelve months and is 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.
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 adopted SFAS 123(R) using the modified-prospective
method and use the Black-Scholes valuation model for valuing 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 CytRx and RXi common stock option grant is estimated using the Black-Scholes
option pricing model, which uses certain assumptions related to risk-free interest rates, expected
volatility, expected life of the common stock options and future dividends. Compensation expense
is recorded based upon the value derived from the Black-Scholes option pricing model, based on an
expected forfeiture rate that is adjusted for actual experience. If our Black-Scholes option
pricing model assumptions or our actual or estimated forfeiture rate are different in the future,
that could materially affect compensation expense recorded in future periods.
16
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 20.4
million shares and 29.2 million shares at June 30, 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 dividends of $488,000. The 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 consolidated statement of operations and for purposes of calculating basic and
diluted loss per shares.
Liquidity and Capital Resources
At June 30, 2007, we had cash and cash equivalents of $69.7 million and total assets of $72.7
million, compared to $30.4 million and $31.6 million, respectively, at December 31, 2006. Working
capital totaled $59.9 million at June 30, 2007, compared to $20.3 million at December 31, 2006.
We have relied primarily upon sales of our 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 June
30, 2007, we had cash and cash equivalents of $69.7 million, including $19.2 million that we
received from the sale of shares in our 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.
Management believes that we have adequate financial resources to support our currently planned
level of operations into the second half of 2009. That belief is based in part on projected
expenditures through the remainder of 2007 and the first half of 2008
of $24.5 million, including
$7.3 million for our Phase IIb trial of arimoclomol for ALS and related studies and $10.8 million
for our other clinical programs, including a planned Phase II clinical trial of arimoclomol in
stroke patients and a planned Phase II clinical trial of iroxanadine for diabetic foot ulcers
(which we estimate will, through completion, cost $10.0 million and $5.6 million, respectively).
Management estimates that RXi separately will expend approximately
$8.2 million on development
activities through the remainder of 2007 and the first half of 2008. Managements estimate
regarding our financial resources assumes that no second efficacy trial will be required for
arimoclomol for ALS. If we undertake an additional efficacy trial, our actual expenses will be
materially greater than currently estimated. 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, which includes non-cash charges relating to (1) common stock, stock option and
warrants issued for services (2) common stock issued related to the acquisition of licensing rights
and (3) expenses related to employee stock options, increased by approximately $700,000 from the
quarter ended June 30, 2006 to the quarter ended June 30, 2007. This increase was due to several
factors including our subsidiary RXis issuance of approximately 462,000 shares with an estimated
fair value $2.3 million for the licensing rights of certain technologies and a new invention
disclosure agreement, as well as the recognition of option expense of $1.1 million related to the
issuance of options to RXis employees, members of its board of directors and scientific advisory
board. These
17
non cash increases in net loss were offset in part by $2.4 million in deferred revenue
related to our $24.3 million sale to the ALS Charitable Remainder Trust of a 1% royalty interest in
worldwide sales of arimoclomol in August 2006.
In the six months ended June 30, 2007 and 2006, net cash used in investing activities
consisted of approximately $38,000 and $22,000, respectively, for the purchase of equipment. We
expect capital spending during the second half of 2007 to be higher than the first six months of
2007 due to additional laboratory equipment necessary for our new San Diego laboratory.
Cash provided by financing activities in the six months ended June 30, 2007 was $50.2 million.
During the 2007 period, we raised $34.2 million, net of offering expenses of $2.8 million, from the
issuance of 8.6 million shares of common stock in a private equity financing in April of 2007, and
received proceeds from the exercise of stock options and warrants of approximately $15.9 million.
Cash provided by financing activities in the six months ended June 30, 2006 was approximately $12.7
million. During the 2006 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 $339,000.
As a result of the activities described above, our cash and cash equivalents at June 30, 2007
were approximately $39.3 million more than at December 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
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 $6.2 million and
$10.8 million for the three and six month periods ended June 30, 2007, respectively, as compared to
$5.5 million and $10.1 for the same periods in 2006.
We recognized $2.4 million and $3.9 million of revenue for the three and six month periods
ended June 30, 2007, and had no material revenue for the same periods in 2006. We recognized $2.4
million and $3.8 million from our $24.3 million sale to the ALS Charitable Remainder Trust of a 1%
royalty interest in worldwide sales of arimoclomol in 2007. Additionally during the three month
period ended June 30, 2007, we recognized $1.5 million of other income related to a
change-in-control provision included in the purchase agreement for our 1998 sale of our animal
pharmaceutical unit. 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. We will continue to recognize the balance of the deferred revenue recorded from the
royalty transaction with the ALS Charitable Remainder Trust over the development period of our
arimoclomol research.
Research and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Period |
|
|
Six-Month Period |
|
|
|
Ended June 30, |
|
|
Ended June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
|
(In thousands) |
|
|
(In thousands) |
|
Research and development expense |
|
$ |
3,427 |
|
|
$ |
3,035 |
|
|
$ |
6,267 |
|
|
$ |
5,165 |
|
Non-cash research and development expense |
|
|
2,650 |
|
|
|
61 |
|
|
|
3,323 |
|
|
|
105 |
|
Employee stock option expense |
|
|
144 |
|
|
|
77 |
|
|
|
181 |
|
|
|
160 |
|
Depreciation and amortization |
|
|
45 |
|
|
|
32 |
|
|
|
112 |
|
|
|
87 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
6,266 |
|
|
$ |
3,205 |
|
|
$ |
9,883 |
|
|
$ |
5,517 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
18
Research and development expenses incurred during the first three and six month periods 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 acquisition of technologies covered by the UMMS license agreements acquired by our RXi
subsidiary, (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 $2.7 million and $3.3 million for the three and six month periods
ended June 30, 2007 and $61,000 and $105,000 for the same periods ended June 30, 2006. Included in
the non-cash research and development charges were $2.3 million of expense related to RXis
issuance of 462,112 shares of common stock to UMMS related for certain license agreement rights and
the new invention disclosure agreement. Additionally, we recognized $732,000 of option expense as a
result of RXis issuance of options to members of its scientific advisory board members during the
three months ended June 30, 2007. With our adoption of SFAS 123(R) during 2006, we recorded
$144,000 and $181,000 of employee stock option expense during the three and six month periods ended
June 30, 2007, as compared with $77,000 and $160,000 for the related periods in 2006. The increase
is primarily related to the hiring of additional staff related to the anticipation of the opening
of our new San Diego facility.
In 2007, we expect our research and development expenses to increase primarily as a result of
our ongoing Phase II clinical program for arimoclomol and related studies for the treatment of ALS,
our potential Phase II clinical trial of arimoclomol for stroke recovery, our further development
of iroxanadine for diabetic wound healing and the continued development of our RNAi assets by our
majority-owned subsidiary RXi. We are currently evaluating our estimates for our clinical program
for arimoclomol for the treatment of ALS, including the completion of the planned Phase IIb
efficacy clinical trial and related studies. We recently announced that an additional efficacy
trial may be required prior to any FDA approval for arimcolomol for ALS. If we undertake an
additional efficacy trial, our actual research and development expenses will be materially greater
than currently estimated.
General and administrative expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Period |
|
|
Six-Month Period |
|
|
|
Ended June 30, |
|
|
Ended June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
|
(In thousands) |
|
|
(In thousands) |
|
General and administrative expenses |
|
$ |
3,893 |
|
|
$ |
2,057 |
|
|
$ |
6,655 |
|
|
$ |
3,746 |
|
Non-cash general and administrative expenses |
|
|
|
|
|
|
58 |
|
|
|
|
|
|
|
126 |
|
Employee stock option expense |
|
|
599 |
|
|
|
274 |
|
|
|
710 |
|
|
|
536 |
|
Depreciation and amortization |
|
|
5 |
|
|
|
48 |
|
|
|
9 |
|
|
|
52 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
4,497 |
|
|
$ |
2,437 |
|
|
$ |
7,374 |
|
|
$ |
4,460 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 $2.1 million and $2.9 million for the three and
six months ended June 30, 2007, respectively, as compared to the same time periods in 2006. The
increase in general and administrative expenses was as a result of salary, stock-based compensation
and consulting expenses related to RXi of $1.1 million for each
of the three and six
months ended June 30, 2007, respectively, for which there were no corresponding expense in 2006.
Also, contributing to the increase are higher levels of accounting and consulting expenses
primarily related to our efforts to comply with the attestation requirements of Section of the
Sarbanes-Oxley Act, as well as an increase in our overall salary level. Additionally, we incurred
higher legal fees during 2007, primarily related to our the formation funding efforts 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 our consulting expenses related to information technology to
decrease in the remainder of 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
19
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 approximately $599,000 and $710,000 million of
employee stock option expense during the three and six months ended June 30, 2007, respectively, as
compared to approximately $274,000 and $536,000, respectively during the three and six months ended
June 30, 2006. The increase in employee stock option expense relates primarily to stock option
grants by RXi and the overall increase in our common share price.
Depreciation and amortization
Depreciation and amortization expenses for the three and six months ended June 30, 2007 were
approximately $49,000 and $121,000, as compared to $80,000 and $139,000 for the three and six
months ended June 30, 2006, respectively. The depreciation expense reflects the depreciation of our
equipment and furnishings and the amortization expenses related to our molecular library, which was
placed in service in March 2005.
Interest income
Interest income was $659,000 and $1.0 million for the three and six months ended June 30,
2007, respectively, compared to $177,000 and 284,000, respectively for the comparable periods of
2006. The variances between periods is attributable primarily to the 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 six months ended June 30, 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
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.
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 $15.0 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. Under the terms of Dr. Woolfs employment agreement he is entitled to base
annual compensation and other employee benefits. Additionally, he received a grant by RXi of
options to purchase 317,000 shares of RXi common stock. 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 of his status as RXis President and Chief Executive Officer and in light of the
stock options granted to him by RXi.
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 June 30, 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
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
20
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. There were no changes made during our most
recently completed fiscal quarter in our internal control over financial reporting that has
materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
During the period covered by this Quarterly Report on Form 10-Q, we identified a material
weakness in our internal controls over financial reporting related to the process for closing our
books and records for purposes of preparing our quarterly financial statements. The deficiencies
in this regard related primarily to the effectiveness of our controls over the increasingly complex business and
operations of RXi that commenced in January of this year, as well as
our lack of sufficient, effective accounting personnel. We are in the process of seeking to hire additional accounting personnel, we
are evaluating our procedures for closing our books and records, and we intend to enhance our
internal review of books and records in the future to ensure the effectiveness of all
aspects of our internal controls.
We are continuing our efforts to improve and strengthen our control processes to fully remedy
this material weakness 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.
21
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 recorded a net loss applicable to common shareholders of approximately $6.2 million and
$10.8 million for the three and six month periods ended June 30, 2007, as compared to $5.5 million
and $10.1 million for the same periods in 2006. Additionally, 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 such time, if ever, as 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 $2.4 million and $3.9 million, respectively, for the three and six
months ended June 30, 2007, of which $2.4 million and $3.8 million, respectively, was deferred
service revenue related to our sale in August 2006 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 sales of our 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 June
30, 2007, we had cash and cash equivalents of $69.7 million, including $19.2 million that we
received from the sale of shares in our 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.
Management believes that we have adequate financial resources to support our currently planned
level of operations into the second half of 2009. That belief is based in part on projected
expenditures through the remainder of 2007 and the first half of 2008
of $24.5 million, including
$7.3 million for our Phase IIb trial of arimoclomol for ALS and related studies and $10.8 million
for our other clinical programs, including a planned Phase II clinical trial of arimoclomol in
stroke patients and a planned Phase II clinical trial of iroxanadine for diabetic foot ulcers
(which we estimate will, through completion, cost $10.0 million and $5.6 million, respectively).
Management estimates that RXi separately will expend approximately
$8.2 million on development
activities through the remainder of 2007 and the first half of 2008. Managements estimate
regarding our financial resources assumes that no second efficacy trial will be required for
arimoclomol for ALS. If we undertake an additional efficacy trial, our actual expenses will be
materially greater than currently estimated. We anticipate that it will take a minimum of three
years, and possibly longer, for us to generate significant 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.
22
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 efficacy trial and related studies, will require us to incur
approximately $20.4 million (including amounts payable under the Master Agreement for Clinical
Trials Management Services Agreement we have entered into with Pharmaceutical Research Associates)
over the next two to three years, assuming we receive FDA clearance for this trial. We recently
announced that an additional efficacy trial may be required prior to any FDA approval for
arimcolomol for ALS. Our current estimate that we will incur approximately $20.4 million of
research and development expenses assumes that no additional efficacy trial will be required for
arimoclomol for ALS. If we undertake an additional efficacy trial, our actual research and
development expenses will be materially greater than currently estimated. 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 and iroxanadine for diabetic foot ulcers, 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.
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. |
|
|
|
|
Difficulty in enrolling patients in conformity with required protocols or projected timelines. |
|
|
|
|
Unexpected adverse reactions by patients in trials. |
|
|
|
|
Difficulty in obtaining clinical supplies of the product. |
|
|
|
|
Changes in FDA or foreign governmental requirements for our testing during the course of that testing. |
|
|
|
|
Inability to generate statistically significant data confirming the efficacy of the product being tested. |
|
|
|
|
Modification of the drug during testing. |
23
|
|
|
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 trial of arimoclomol
for the treatment of ALS, and in June 2007 we announced results of the six-month open label
extension of that clinical trial. In the Phase IIa clinical trial, 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 the results of any
subsequent clinical trials, or that the FDA will permit us to commence our planned Phase IIb
efficacy trial on a timely basis or at all. We recently announced that a second efficacy trial may
be required prior to any FDA approval for arimoclomol for ALS. The requirements imposed by the FDA
in connection with our clinical trials could add to the time and expense for us to carry out this
trial.
Based upon the positive results of recent preclinical studies in animals, we are planning to
conduct a Phase II clinical trial 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 have previously announced our plan to conduct clinical
development of iroxanadine for diabetic 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.
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.
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. More recently, a
material weakness in the effectiveness of our internal controls over financial reporting was
identified in connection with the preparation of our financial statements for the three months
ended June 30, 2007 included in this Quarterly Report. The material weakness related to the
process for closing our books and records for purposes of preparing our quarterly financial
statements. For more information with respect to this material weakness, see the discussion in the
section Item 4 Controls and Procedures of this Quarterly Report. 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.
24
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:
|
|
|
Succeed in developing competitive products sooner than us or our strategic partners or licensees. |
|
|
|
|
Obtain FDA and other regulatory approvals for their products before we can obtain approval of any of our products. |
|
|
|
|
Obtain patents that block or otherwise inhibit the development and commercialization of our product candidates. |
|
|
|
|
Develop products that are safer or more effective than our products. |
|
|
|
|
Devote greater resources to marketing or selling their products. |
|
|
|
|
Introduce or adapt more quickly to new technologies and other scientific advances. |
|
|
|
|
Introduce products that render our products obsolete. |
|
|
|
|
Withstand price competition more successfully than us or our strategic partners or licensees. |
|
|
|
|
Negotiate third-party strategic alliances or licensing arrangements more effectively. |
|
|
|
|
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. 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,
Phytopharm 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., Biogen Idec, Boehringer
Ingelheim, Cephalon, Inc., Ceregene, Inc., Elan Pharmaceuticals, plc, Forest Laboratories, Inc., H.
Lundbeck A/S, and Schwarz Pharma AG and Wyeth.
A number of proprietary and generic 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 CytRx.
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
25
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.
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:
26
RXi is Subject to Risks of a New Business
RXi is a discovery-stage company with limited 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, 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 scientific discoveries that form the basis for RXis efforts to discover and develop new
drugs are relatively new. 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. Neither RXi nor any other company has ever received
regulatory approval to market therapeutics that utilize RNAi. 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.
The FDA Approval Process May be Delayed for Any Drugs RXi Develops That Require the Use of
Specialized Drug Delivery Devices or Vehicles
Some drug candidates that RXi may develop may need to be administered using specialized
vehicles that deliver RNAi therapeutics to diseased parts of the body. While RXi expects to rely on
drug delivery vehicles that have been approved by the FDA or other regulatory agencies, RXi may
need to modify the design or labeling of these delivery vehicles for products that it may develop.
In such event, the FDA may regulate the product as a combination product of a drug and a device, or
require additional approvals or clearances for the modified delivery. To the extent any specialized
delivery vehicle is owned by another, RXi would need that companys cooperation to implement the
necessary changes to the vehicle, or its labeling, and to obtain any additional approvals or
clearances. Any delays in finding suitable drug delivery vehicles to administer RNAi therapeutics
directly to diseased parts of the body could negatively affect RXis ability to successfully
commercialize its RNAi therapeutics.
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 & Mello foundational patent owned by UMMS and the Carnegie Institution of Washington, which
claims various aspects of RNAi (sometimes referred to as gene silencing), or genetic inhibition by
double-stranded RNA. This license continues to be available to third parties, and as such, it does
not provide RXi with the ability to exclude others from its use or protect RXi 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 does not
currently expect to 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.
In addition, others may challenge the patent owned by UMMS and the Carnegie Institution of
Washington or other patents that RXi currently licenses or may license in the future. As a result,
these patents could be narrowed, invalidated or rendered unenforceable, which would negatively
affect RXis ability to exclude others from use of RNAi technologies described in these patents.
27
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.
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
us and 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 fourth quarter of 2008. It is possible, however, that RXi may need to incur
debt or issue equity in order to fund these requirements or to make acquisitions and other
investments. We anticipate that RXi will need to raise substantial amounts of money to fund a
variety of future activities integral to the development of its business, including, but not
limited to, conducting research and development of its RNAi technologies and obtaining regulatory
approval for its products.
We contributed all of our RNAi-related technologies to RXi in order to accelerate the
development and commercialization of drugs based upon 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
28
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.
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., Cequent Pharmaceuticals Inc., Nucleonics, Inc., Tacere
Therapeutics Inc., Benitec Ltd., Opko Corp., Silence Therapeutics plc (formerly SR Pharma plc),
Quark Pharmaceuticals, Inc., Rosetta Genomics Ltd., Calanda Pharmaeuticals, Inc. and Isis
Pharmaceuticals, Inc., and a number of the multinational pharmaceutical companies. Most of 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. In addition, even if RXi is successful in developing
its product candidates, in order to compete successfully, it may need to be first to market or to
demonstrate that its RNAi-based products are superior to therapies based on different technologies.
If RXi is not first to market or is unable to demonstrate such superiority, its products may be not
successful.
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 have 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.
29
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 June 30, 2007, there were outstanding stock options and warrants to purchase
approximately 20.4 million shares of our common stock at a weighted-average exercise price of $1.90
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 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 August 8, 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 August 8, 2007, and may continue to experience significant volatility from
time to time. Factors such as the following may affect such volatility:
|
|
|
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. |
|
|
|
|
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.
30
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Since our Current Report on Form 8-K filed with the Securities and Exchange Commission
on June 1, 2007 and during the quarterly period covered by this Report, we have issued a total of
328,523 shares of our common stock in unregistered sales of our equity securities. The 328,523
shares were issued to two warrant holders in connection with the exercise of outstanding common
stock purchase warrants as follows: 30,904 shares were issued on June 13, 2007 upon the payment of
a warrant exercise price of $2.67 per share; and 297,619 shares were issued on June 13, 2007 upon
the payment of a warrant exercise price of $1.54 per share. The warrants were issued by us in
private placements exempt from registration under the Securities Act of 1933 pursuant to Section
4(2) of the Securities Act of 1933 and Regulation D under the Act. The issuance of the foregoing
shares of common stock upon exercise of the warrants also was exempt from registration under
Section 4(2) and Regulation D.
Item 4. Submission of Matters to a Vote of Security Holders
On July 2, 2007, we held our Annual Meeting of Stockholders. The following are the
results of the proposals:
a) Election of directors:
|
|
|
|
|
|
|
|
|
Nominee |
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For |
|
Withheld |
Louis Ignarro, Ph.D |
|
|
60,873,185 |
|
|
|
10,198,536 |
|
Joseph Rubinfeld, Ph.D. |
|
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61,389,162 |
|
|
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9,682,559 |
|
b) Approval of an amendment to our Restated Certificate of Incorporate to increase the
authorized number of shares of common stock from 125,000,000 to 150,000,000:
|
|
|
|
|
For |
|
|
67,965,220 |
|
Against |
|
|
2,933,884 |
|
Abstain |
|
|
172,615 |
|
c) Ratification of the selection of BDO Seidman, LLP as our independent auditors:
|
|
|
|
|
For |
|
|
70,600,780 |
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Against |
|
|
242,810 |
|
Abstain |
|
|
228,131 |
|
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.
31
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: August 9, 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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32
INDEX TO EXHIBITS
|
|
|
Exhibit |
|
|
Number |
|
Description |
3.1 (a)
|
|
Certificate of Amendment to Restated Certificate of Incorporation |
|
|
|
10.1 *
|
|
Employment Agreement dated April 30, 2007, between CytRx Corporation and Shi Chung Ng |
|
|
|
10.2
|
|
Lease dated July 20, 2007, between CytRx Corporation and BMR-3030 Bunker Hill Street LLC |
|
|
|
31.1
|
|
Certification of Chief Executive Officer Pursuant to 17 CFR 240.13a-14(a) |
|
|
|
31.2
|
|
Certification of Chief Financial Officer Pursuant to 17 CFR 240.13a-14(a) |
|
|
|
32.1
|
|
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 |
|
|
|
32.2
|
|
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 |
|
|
|
* |
|
Indicates a management contract or compensatory plan or arrangement. |
|
(a) |
|
Incorporated by reference to the Corporations Proxy Statement filed May 24, 2007. |
33