e10vqza
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q/A
(Amendment No. 1)
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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
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(Zip Code) |
offices) |
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(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
November 9, 2007:
90,221,370 exclusive of treasury shares.
EXPLANATORY NOTES
CytRx Corporation (CytRx, we, our, us and the Company) is amending in certain
respects our Quarterly Report on Form 10-Q for the quarter ended June 30, 2007, which we sometimes
refer to in this amendment as our original Form 10-Q. The purpose of this amendment is to restate
our condensed consolidated financial statements for the quarter ended June 30, 2007 as described
below. The restatement relates to our accounting for an equity transaction by our majority-owned
subsidiary, RXi Pharmaceuticals Corporation (RXi), the accounting for tax withholding amounts
related to common stock option exercises and the reclassification of certain general and
administrative expenses as research and development expenses.
For the quarter ended June 30, 2007, we originally reported additional paid-in capital of $2.3
million attributable to RXis issuance to the University of Massachusetts Medical School, or UMMS,
of approximately 462,000 shares of RXi common stock in payment for RXis acquisition of four
technology licenses and an invention disclosure agreement entered into with UMMS in January 2007
that should have been accounted for on our consolidated balance sheet as minority interest in RXi.
This accounting correction resulted in a corresponding reduction of $2.3 million in our additional
paid-in capital and stockholders equity as of June 30, 2007, as well as an increase in loss
attributable to minority interests and a decrease in our consolidated net loss of $176,000 for both
the three-month and six-month periods ended June 30, 2007. Additionally, we originally reported
$227,000 in payroll taxes and other withholdings in connection with exercises of employee stock
options as an offset to general and administrative expenses in our consolidated statements of
operations for the three-month and six-month periods ended June 30, 2007. The $227,000 is properly
classified as a current liability as of June 30, 2007, which correction resulted in an increase in
our consolidated net loss by the same amount for both the three-month and six-month periods ended
June 30, 2007. The net effect of the correction of both of these items was a $51,000 increase in
our consolidated net loss for the three-month and six-month periods ended June 30, 2007. Our
reported earnings per share for these periods were not affected by these corrections.
For the quarter ended June 30, 2007, our originally-reported general and administrative
expenses included charges of approximately $391,000 that we determined are properly classified as
research and development expenses. The reclassification of these expenses will have no effect on
our consolidated net loss for that period.
The following Items and Exhibits of our original Form 10-Q are amended by this amendment:
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Part I Item 1. Financial Statements (unaudited) |
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Part I Item 2. Managements Discussion and Analysis of Financial Condition and
Results of Operations |
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Part I Item 4. Controls and Procedures |
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Part II Item 6. Exhibits |
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Exhibit 31.1 Certification of Chief Executive Officer |
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Exhibit 31.2 Certification of Chief Financial Officer |
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Exhibit 32.1 Certification of Chief Executive Officer |
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Exhibit 32.2 Certification of Chief Financial Officer |
Except for the foregoing Items and Exhibits, this amendment does not modify any disclosures
contained in our original Form 10-Q. Additionally, the text of this amendment, except for the
restatement information, speaks as of the filing date of the original Form 10-Q and does not
attempt to update the disclosures in our original Form 10-Q or to discuss any developments
subsequent to the date of the original filing. In accordance with the rules and regulations of the
Securities and Exchange Commission, the information contained in the original Form 10-Q and this
amendment is subject to updated or supplemental information contained in reports filed by us with
the Securities and Exchange Commission subsequent to the filing dates of the original Form 10-Q and
this amendment.
2
TABLE OF CONTENTS
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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(Restated) |
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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, MINORITY INTEREST 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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2,960,002 |
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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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12,193,552 |
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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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23,855,965 |
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26,486,101 |
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Commitment and Contingencies |
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Minority interest in subsidiary |
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2,134,424 |
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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, $.001 par value, 125,000,000 shares authorized;
88,528,000 and 70,789,000 shares issued at June 30, 2007 and
December 31, 2006, respectively |
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88,528 |
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70,789 |
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Additional paid-in capital |
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199,309,674 |
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146,961,657 |
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Treasury stock, at cost (633,816 shares held at June 30, 2007
and December 31, 2006, respectively) |
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(2,279,238 |
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(2,279,238 |
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Accumulated deficit |
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(150,435,832 |
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(139,602,869 |
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Total stockholders equity |
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46,683,132 |
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5,150,339 |
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Total liabilities, minority interest and stockholders equity |
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$ |
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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(Restated) |
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(Restated) |
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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: $175,000
and $77,000 of employee stock-based
compensation expense for the three
months ended June 30, 2007 and 2006,
respectively, $212,000 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;
$1,315,000 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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6,884,296 |
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3,205,372 |
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10,892,670 |
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5,517,383 |
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General and administrative (includes
non-cash expense as follows: $568,000
and $274,000 of employee stock-based
compensation for the three months ended
June 30, 2007 and 2006, respectively,
and $679,000 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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4,106,597 |
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2,436,916 |
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6,591,681 |
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4,459,582 |
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10,990,893 |
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5,642,288 |
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17,484,351 |
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9,976,965 |
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Loss before other income |
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(8,620,380 |
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(5,642,288 |
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(13,550,775 |
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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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176,136 |
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178,136 |
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Net loss applicable to common shareholders
before deemed dividend |
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(6,285,182 |
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(5,465,380 |
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(10,832,963 |
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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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$ |
(6,285,182 |
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$ |
(5,465,380 |
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$ |
(10,832,963 |
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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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(Restated) |
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Cash flows from operating activities: |
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Net loss |
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$ |
(10,832,963 |
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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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(178,136 |
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Common stock, stock options and warrants issued for services |
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2,895,605 |
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230,547 |
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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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(4,431,803 |
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788,796 |
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Total adjustments |
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29,607 |
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1,854,662 |
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Net cash used in operating activities |
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(10,803,356 |
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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 cash provided by financing activities |
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50,157,837 |
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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
6
received under the arrangement as deferred service revenue and will recognize service revenue
using the proportional performance method of revenue recognition, meaning that service revenue is
recognized as a percentage of actual research and development expense incurred for the research and
development of arimoclomol or the development of other ALS treatments.
The accompanying condensed consolidated financial statements at 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.
The accompanying condensed consolidated financial statements have been restated to reflect
corrections in our accounting for an equity transaction by RXi, the accounting for tax withholding
amounts related to common stock option exercises and the classification of certain general and
administrative expenses as research and development expenses. The consolidated balance sheet as of
June 30, 2007 was restated to reflect an increase of $2.3 million in minority interest in RXi
(offset by approximately $178,000 of losses attributable to that minority interest), and a
corresponding reduction of $2.3 million in additional paid-in capital and stockholders equity, as well as a
$227,000 increase in current liabilities.
The consolidated statements of operations were restated to reflect a $51,000 increase in our
consolidated net loss for the three-month and six-month periods ended June 30, 2007, in arriving at
the net loss applicable to common stockholders of $6,285,182 and $10,832,963 for the those periods,
respectively. The restated net loss applicable to common stockholders did not change the net loss
per share of $.07 and $.14 for those periods, respectively. The consolidated statements of
operations were also restated to reflect approximately $391,000 of expenses that were reclassified
from general and administrative expenses to research and development expenses for both the
three-month and six-month periods ended June 30, 2007.
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.
7
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 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.
8
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 $1,315,000 and $105,000 of stock based compensation expense related to non-employee
common stock options for the 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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9
A summary of the activity for non-vested 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 |
Non-vested 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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-vested 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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
10
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 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 non-vested 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 |
Non-vested at January 1, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
829,000 |
|
|
|
348,000 |
|
|
|
1,177,000 |
|
|
$ |
5.00 |
|
Forfeited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested |
|
|
(97,000 |
) |
|
|
(216,000 |
) |
|
|
(313,000 |
) |
|
$ |
5.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-vested at June 30, 2007 |
|
|
732,000 |
|
|
|
132,000 |
|
|
|
864,000 |
|
|
$ |
5.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11
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 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
12
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 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.
13
8. Minority Interest
The Company offset against its net loss
$178,136 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 there were no subsidiary losses. This loss was the minority shareholders
portion of the loss attributed to RXi and was limited to the extent of their investment.
9. 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 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
14
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 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
15
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.
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
16
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.
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.
17
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 $59.7 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 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.
18
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 $6.3 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 |
|
|
|
(Restated) |
|
|
|
|
|
(Restated) |
|
|
|
|
|
|
(In thousands) |
|
|
(In thousands) |
|
Research and development expense |
|
$ |
4,014 |
|
|
$ |
3,035 |
|
|
$ |
7,245 |
|
|
$ |
5,165 |
|
Non-cash research and development expense |
|
|
2,650 |
|
|
|
61 |
|
|
|
3,323 |
|
|
|
105 |
|
Employee stock option expense |
|
|
175 |
|
|
|
77 |
|
|
|
212 |
|
|
|
160 |
|
Depreciation and amortization |
|
|
45 |
|
|
|
32 |
|
|
|
112 |
|
|
|
87 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
6,884 |
|
|
$ |
3,205 |
|
|
$ |
10,892 |
|
|
$ |
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.
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
19
its scientific advisory board members during the three months ended June 30, 2007. With our
adoption of SFAS 123(R) during 2006, we recorded $175,000 and $212,000 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 an 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 |
|
|
|
(Restated) |
|
|
|
|
|
|
(Restated) |
|
|
|
|
|
|
|
(In thousands) |
|
|
(In thousands) |
|
General and administrative expenses |
|
$ |
3,534 |
|
|
$ |
2,057 |
|
|
$ |
5,904 |
|
|
$ |
3,746 |
|
Non-cash general and administrative expenses |
|
|
|
|
|
|
58 |
|
|
|
|
|
|
|
126 |
|
Employee stock option expense |
|
|
568 |
|
|
|
274 |
|
|
|
679 |
|
|
|
536 |
|
Depreciation and amortization |
|
|
5 |
|
|
|
48 |
|
|
|
9 |
|
|
|
52 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
4,107 |
|
|
$ |
2,437 |
|
|
$ |
6,592 |
|
|
$ |
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 $1.7 million and $2.1 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 $1.0 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 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 $568,000 and $679,000 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.
20
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 $178,136 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 there were no subsidiary losses. 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 4 Controls and Procedures
Our management, with the participation of our Chief Executive Officer and our Chief Financial
Officer at that time, 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
June 30, 2007, the end of the period covered by our original Form 10-Q. Based on that evaluation,
our Chief Executive Officer and former Chief Financial Officer concluded that our disclosure
controls and procedures were effective to ensure that information required to be disclosed by us in
reports that we file or submit under the Securities Exchange Act of 1934 is recorded, processed,
summarized and reported within the time periods specified in the rules and forms of the Securities
and Exchange Commission. There were no changes made during the period covered by our original Form
10-Q 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 originally 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.
Subsequently, in conjunction with the preparation of our Quarterly Report on Form 10-Q for the
quarter ended September 30, 2007, our management, with the participation of our Chief Executive
Officer and our new Chief Financial Officer, identified new deficiencies, discussed below, that it
considered to be material weaknesses in the effectiveness of our internal controls over financial
reporting related to the recording of journal entries and our accounting for equity transactions.
Pursuant to standards established by the Public Company Accounting Oversight Board, a material
weakness is a deficiency or combination of deficiencies in internal control over financial
reporting, such that there is a reasonable possibility that a material misstatement of the
companys annual or interim financial statements will not be prevented or detected on a timely
basis.
21
For the quarter ended June 30, 2007, we reported additional paid-in capital of $2.3 million
attributable to RXis issuance to the University of Massachusetts Medical School, or UMMS, of
approximately 462,000 shares of RXi common stock in payment for RXis acquisition of four
technology licenses and an invention disclosure agreement entered into with UMMS in January 2007.
In the restatement, the $2.3 million is properly reflected as minority interest in RXi, resulting
in a corresponding reduction in additional paid-in capital and stockholders equity. We also
recorded an increased loss attributable to minority interests of approximately $176,000 in the
consolidated statements of operations for the three-month and six-month periods ended June 30,
2007, which resulted in decreases in our consolidated net loss by the same amount for the
respective periods. Additionally, during the quarter ended June 30, 2007, we originally reported
$227,000 in amounts withheld from employees for income taxes on compensation derived from exercises
of options to purchase our common stock as an offset to general and administrative expenses in the
consolidated statements of operations for the three-month and six-month periods ended June 30,
2007. In the restatement, the $227,000 is reclassified as a current liability on the balance sheet
as of June 30, 2007, which resulted in an increase in our consolidated net loss by the same amount
for both the three-month and six-month periods ended June 30, 2007 consolidated statements of
operations. The net effect of the correction of both of these items was a $51,000 increase in our
consolidated net loss reported in the consolidated statements of operations for the three-month and
six-month periods ended June 30, 2007, which did not result in any change in our reported earnings
per share for these same periods.
Based on the evaluation of the effectiveness of the design and operation of our disclosure
controls and procedures, our Chief Executive
Officer and new Chief Financial Officer concluded that, in addition to the material weakness identified in the original Form 10-Q for the period ended June 30, 2007, our disclosure controls and procedures over
our recording of journal entries and our accounting for equity transactions were not effective as
of June 30, 2007.
We continuously seek to improve and strengthen our control processes 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 weaknesses 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.
22
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.
|
|
|
|
|
|
CYTRX CORPORATION
(Registrant)
|
|
Date: November 13, 2007 |
By: |
/s/ MITCHELL K. FOGELMAN
|
|
|
|
Mitchell K. Fogelman |
|
|
|
Chief Financial Officer (Principal Financial and Accounting Officer) |
|
|
23
INDEX TO EXHIBITS
|
|
|
Exhibit |
|
|
Number |
|
Description |
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 Financial Officer Pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002 |
24