10-Q/A 09-30-06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q/A
Amendment No. 1
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þ |
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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 September 30, 2006
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 0-15327
CYTRX CORPORATION
(Exact name of Registrant as specified in its charter)
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Delaware
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58-1642740 |
(State or other jurisdiction
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(I.R.S. Employer Identification No.) |
of incorporation or organization) |
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11726 San Vicente Blvd. |
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Suite 650 |
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Los Angeles, CA
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90049 |
(Address of principal executive offices)
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(Zip Code) |
Registrants telephone number, including area code: (310) 826-5648
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 o Non-accelerated filer þ
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
There were 76,788,694 shares of CytRx Corporation Common Stock, $.001 par value, issued
and outstanding as of March 23, 2007, exclusive of treasury shares.
EXPLANATORY NOTE
CytRx Corporation (the Company) is amending in certain respects its Quarterly Report on Form
10-Q for the quarter year ended September 30, 2006, 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 September 30, 2006 as described below.
The restatement of our condensed consolidated financial statements is related to a
reclassification of certain expenses related to the operations of our Massachusetts laboratory.
The restatement also includes a correction of the accounting for historical anti-dilution
adjustments in certain of our outstanding warrants in the quarters ended September 30, 2006 and
2005, respectively.
On March 30, 2007, the Audit Committee of our Board of Directors approved managements
recommendation to restate our condensed consolidated financial statements for the quarter ended
June 30, 2006 to reflect the expense reclassification and the correction of the accounting for
historical anti-dilution adjustments in certain of our outstanding warrants.
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 |
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.
CYTRX CORPORATION
Form 10-Q
Table of Contents
Part I FINANCIAL INFORMATION
Item 1. Financial Statements
CYTRX CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
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September 30, |
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December 31, |
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2006 |
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2005 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
33,709,677 |
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$ |
8,299,390 |
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Accounts receivable |
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172,860 |
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Prepaid compensation, current portion |
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27,813 |
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Prepaid and other current assets |
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357,449 |
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287,793 |
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Total current assets |
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34,067,126 |
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8,787,856 |
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Equipment and furnishings, net |
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309,914 |
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352,641 |
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Molecular library, net |
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305,838 |
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372,973 |
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Prepaid insurance and other assets |
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395,994 |
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425,440 |
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Total assets |
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$ |
35,078,872 |
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$ |
9,938,910 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
762,287 |
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$ |
815,626 |
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Accrued expenses and other current liabilities |
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1,833,298 |
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1,639,922 |
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Total current liabilities |
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2,595,585 |
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2,455,548 |
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Deferred revenue |
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23,831,408 |
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275,000 |
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Total liabilities |
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26,426,993 |
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2,730,548 |
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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, $.001 par value, 125,000,000
shares authorized; 70,618,000 and 59,284,000
shares issued at September 30, 2006 and
December 31, 2005, respectively |
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70,618 |
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59,284 |
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Additional paid-in capital |
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146,315,401 |
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131,790,932 |
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Treasury stock, at cost (633,816 shares held
at September 30, 2006 and December 31, 2005,
respectively) |
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(2,279,238 |
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(2,279,238 |
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Accumulated deficit |
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(135,454,902 |
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(122,362,616 |
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Total stockholders equity |
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8,651,879 |
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7,208,362 |
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Total liabilities and stockholders equity |
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$ |
35,078,872 |
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$ |
9,938,910 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
1
CYTRX CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
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Three Months Ended |
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Nine-Months Ended |
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September 30, |
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September 30, |
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2006 |
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2005 |
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2006 |
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2005 |
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(restated) |
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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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$ |
775,000 |
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$ |
10,000 |
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$ |
835,831 |
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$ |
10,000 |
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License fees |
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1,000 |
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1,000 |
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1,500 |
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776,000 |
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10,000 |
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836,831 |
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11,500 |
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Expenses: |
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Research and development (includes
$92,000 and $197,000 of non-cash
stock-based compensation given to
consultants for the three and nine-month
periods ended September 30, 2006 and
$32,000 and $122,000 of non-cash
stock-based compensation given to
consultants for the three and nine-month
periods ended September 30, 2005,
respectively) |
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1,564,126 |
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1,990,963 |
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6,834,066 |
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6,820,952 |
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Depreciation and amortization |
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53,243 |
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58,074 |
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192,184 |
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158,486 |
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General and administrative (includes $0
and $32,000 of non-cash stock-based
compensation given to consultants for
the three and nine-month periods ended
September 30, 2006 and $26,000 and
$342,000 of non-cash stock-based
compensation given to consultants for
the three and nine-month periods ended
September 30, 2005) |
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1,907,827 |
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1,493,853 |
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5,779,533 |
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4,765,759 |
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Expense related to employee stock options |
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379,011 |
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1,075,389 |
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3,904,207 |
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3,542,890 |
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13,881,172 |
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11,745,197 |
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Loss before other income |
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(3,128,207 |
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(3,532,890 |
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(13,044,341 |
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(11,733,697 |
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Other income: |
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Interest and dividend income |
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296,086 |
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40,420 |
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580,483 |
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124,150 |
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Minority interest in losses of subsidiary |
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81,452 |
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Net loss before income taxes |
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(2,832,121 |
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(3,532,890 |
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(12,463,858 |
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(11,733,697 |
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Provision for income taxes |
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(140,000 |
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(140,000 |
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Net loss |
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$ |
(2,972,121 |
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$ |
(3,492,470 |
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$ |
(12,603,858 |
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$ |
(11,528,095 |
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Deemed dividend for anti-dilution adjustments
made to outstanding common stock warrants |
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(488,429 |
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(1,075,568 |
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Net loss applicable to common stockholders |
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$ |
(2,972,121 |
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$ |
(3,492,470 |
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$ |
(13,092,287 |
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$ |
(12,603,663 |
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Basic and
diluted loss per share, as originally stated |
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$ |
(0.04 |
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$ |
(0.06 |
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$ |
(0.19 |
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$ |
(0.20 |
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Basic and
diluted loss per share, as restated |
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$ |
(0.04 |
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$ |
(0.06 |
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$ |
(0.19 |
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$ |
(0.22 |
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Weighted average shares outstanding |
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67,421,958 |
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58,190,792 |
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67,463,477 |
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56,367,717 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
2
CYTRX CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
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Nine-Months Ended September 30, |
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2006 |
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2005 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(12,603,858 |
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$ |
(11,528,095 |
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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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192,184 |
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158,486 |
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Minority interest in losses of subsidiary |
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(81,452 |
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Gain on Atlanta lease termination |
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(163,000 |
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Common stock, stock options and warrants issued for services |
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228,432 |
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485,230 |
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Expense related to employee stock options |
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1,075,389 |
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Net change in operating assets and liabilities |
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23,856,908 |
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(461,594 |
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Total adjustments |
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25,352,913 |
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(62,330 |
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Net cash provided/(used) in operating activities |
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12,749,055 |
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(11,590,425 |
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Cash flows from investing activities: |
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Purchases of property and equipment |
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(82,322 |
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(38,740 |
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Net cash used in investing activities |
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(82,322 |
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(38,740 |
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Cash flows from financing activities: |
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Net proceeds from exercise of stock options and warrants |
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339,194 |
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251,619 |
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Net proceeds from issuances of common stock |
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12,404,360 |
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19,590,446 |
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Net cash provided by financing activities |
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12,743,554 |
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19,842,065 |
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Net increase in cash and cash equivalents |
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25,410,287 |
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8,212,900 |
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Cash and cash equivalents at beginning of period |
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8,299,390 |
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2,999,409 |
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Cash and cash equivalents at end of period |
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$ |
33,709,677 |
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$ |
11,212,309 |
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Non-Cash Financing Activities:
In connection with the Companys adjustment to the terms of certain outstanding warrants on
January 20, 2005 and March 2, 2006, the Company recorded deemed dividends of $1,075,568 and
$488,429, respectively, which were recorded as charges to retained earnings with a corresponding
credit to additional paid-in capital.
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
CYTRX CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2006
(Unaudited)
1. Description of Company and Basis of Presentation
CytRx Corporation (CytRx or the Company) is a biopharmaceutical research and development
company, based in Los Angeles, California, with an obesity and type 2 diabetes research laboratory
in Worcester, Massachusetts (see Note 11 to our financial statements for the year ended December
31, 2005). On September 30, 2005, the Company completed the merger of CytRx Laboratories, Inc.,
previously a wholly owned subsidiary of the Company and the owner of its Massachusetts laboratory
(the Subsidiary), with and into the Company. The Companys small molecule therapeutics efforts
include the clinical development of three, oral drug candidates that it acquired in October 2004,
as well as a drug discovery operation conducted by its laboratory in Worcester, Massachusetts. The
Company owns the rights to a portfolio of technologies, including ribonueleic acid interference
(RNAi or gene silencing) technology in the treatment of specified diseases, including those within
the areas of amyotrophic lateral sclerosis (ALS or Lou Gehrigs disease), obesity and type 2
diabetes and human cytomegalovirus (CMV). In addition, the Company announced that a novel HIV DNA +
protein boost vaccine exclusively licensed to the Company and developed by researchers at
University of Massachusetts Medical School (UMMS) and Advanced BioScience Laboratories (ABL), and
funded by the National Institutes of Health, demonstrated promising interim Phase I clinical trial
results that indicate its potential to produce potent antibody responses with neutralizing activity
against multiple HIV viral strains. The Company has entered into strategic alliances with third
parties to develop several of the Companys other products.
In 2004, the Company began a development program based on molecular chaperone co-induction
technology through the acquisition of novel small molecules with broad therapeutic applications in
neurology, type 2 diabetes, cardiology and diabetic complications. The acquired assets included
three oral, clinical stage drug candidates and a library of 500 small molecule drug candidates. In
September 2006, the Company announced results of its Phase IIa clinical testing of its lead small
molecule product candidate arimoclomol for the treatment of ALS, reporting that arimoclomol had met
the trials primary endpoints of safety and tolerability at all three doses tested, and that the
trial results indicated a non-statistically-significant trend of improvement in functional capacity
as measured by the Revised ALS Functional Ration Scale in the arimoclomol high dose group as
compared with untreated patients. Arimoclomol has received Orphan Drug and Fast Track designation
from the U.S. Food and Drug Administration.
To date, the Company has relied primarily upon selling equity securities and a sale of a
royalty interest in arimoclomol and, to a much lesser extent, upon payments from its strategic
partners and licensees and upon proceeds received upon the exercise of options and warrants to
generate the funds needed to finance its operations. Management believes the Companys cash and
cash equivalents balances are sufficient to meet projected cash requirements through the fourth
quarter of 2008. The Company will be required to obtain significant 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 significant additional
funding when needed, it may not be able to execute its business plans and its business may suffer,
which would have a material adverse effect on its financial position, results of operations and
cash flows.
In August 2006, the Company received approximately $24.5 million in marketable securities
(which were sold by the Company for approximately $24.3 million in cash) from the privately-funded
ALS Charitable Remainder Trust (ALSCT) 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
4
the transaction are non-refundable. Further, the ALS Charitable Remainder Trust has no
obligation to provide any further funding to the Company. Management has analyzed the transaction
and concluded that due to the research and development components of the transaction that it is
properly accounted for under SFAS No. 68, Research and Development Arrangements (SFAS No. 68).
Accordingly, the Company has recorded the value received under the arrangement as deferred service
revenue and will recognize service revenue using the proportional performance method of revenue
recognition, meaning that service revenue is recognized as a percentage of actual research and
development expense. As of September 30, 2006, the Company recognized approximately $775,000 of
service revenue related to this transaction.
The accompanying condensed consolidated financial statements at September 30, 2006 and for the
three and nine-month periods ended September 30, 2006 and 2005 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, 2005 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 Securities and Exchange Commission (SEC). Certain information and
footnote disclosures normally included in financial statements prepared in accordance with
accounting principles generally accepted in the U.S. have been condensed or omitted pursuant to
such rules and regulations. The financial statements should be read in conjunction with the
Companys audited financial statements in its Form 10-K for the year ended December 31, 2005. 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 financial statements have been restated to reflect a
reclassification of certain expenses related to the operations of the Companys Massachusetts
laboratory and a correction of the accounting for the Companys historical anti-dilution
adjustments in certain of its outstanding warrants. The statement of operations was restated to
include deemed dividends of $1,075,568 and $488,429 in the first quarters of 2005 and 2006,
respectively, in arriving at the net loss applicable to common stockholders of $12,603,663 and
$13,092,287 for the nine-month periods ended September 30, 2005 and 2006, respectively. The
restated net loss applicable to common stockholders resulted in an increase in net loss per share
from $0.20 to $0.22 for the nine-month period ended September 30, 2005, but did not change the net
loss per share of $0.19 for the same period in 2006. The statement of operations was also restated
to reflect $434,599 and $1,316,721 of expenses that were reclassified from general and administrative expense to
research and development expense for the three and nine-month periods
ended September 30, 2006, respectively.
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 will adopt FIN No. 48 as of January 1, 2007, as required.
While the Company has not yet completed its analysis, we do not expect that the adoption of FIN No.
48 will have a significant 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 September 2006, the Securities and Exchange Commission (SEC) issued Staff Accounting
Bulletin No. 108, Considering the Effects of Prior Year Misstatements when Quantifying
Misstatements in Current Year Financial Statements (SAB 108). SAB 108 provides interpretive
guidance on how the effects of the carryover or reversal of prior year misstatements should be
considered in quantifying a current year misstatement. The SEC staff believes that registrants
should quantify errors using both the balance sheet and income statement approach when quantifying
a misstatement. SAB 108 is effective for the Companys fiscal year ending December 31, 2006. The
Company is currently evaluating the impact of SAB 108 on the Companys consolidated financial
statements.
5
3. Loss Per 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 restricted common
stock. Common share equivalents which potentially could dilute basic
loss 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 29.5 million and 25.0 million shares at September 30, 2006
and 2005, respectively.
Statement of Financial Accounting Standards No. 128, Earnings per Share (SFAS 128)
requires that employee equity share options, nonvested shares and similar equity instruments
granted by the Company be treated as potential common shares outstanding in computing diluted
loss per share. As the Company recorded losses for the three and nine-month periods ended
September 30, 2006 and 2005, all employee equity share options, non-vested shares and similar
equity instruments would be anti-dilutive. In the event the Company becomes profitable, diluted
shares outstanding will include the dilutive effect of in-the-money options which are calculated
based on the average share price for each fiscal period using the treasury stock method. Under the
treasury stock method, the amount the employee must pay for exercising stock options, the amount of
compensation cost for future service that the Company has not yet recognized, and the amount of
benefits that would be recorded in additional paid-in capital when the award becomes deductible are
assumed to be used to repurchase shares.
In connection with our adjustment to the exercise terms of certain outstanding warrants to
purchase common stock on March 2, 2006 and January 20, 2005, we recorded deemed dividends of
$488,000 and $1.1 million, respectively. These deemed dividends are reflected as an adjustment to
net loss for the nine-month periods ended September 30, 2006 and 2005, respectively, 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 share.
4. Stock Based Compensation
As of September 30, 2006, an aggregate of 10,000,000 shares of common stock were reserved for
issuance under the Companys 2000 Stock Option Incentive Plan, including 6,831,000 shares subject
to outstanding stock options and 2,806,000 shares available for future grant. Additionally, the
Company has two other plans, the 1994 Stock Option Plan and the 1998 Long Term Incentive Plan,
which include 31,000 and 100,000 shares subject to outstanding stock options. As the terms of our
plans provide that no options may be issued after 10 years, no options are available under the 1994
Plan. Under the 1998 Long Term Incentive Plan, 40,000 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.
In December 2004, the Financial Accounting Standards Board (FASB) issued Statement of
Accounting Standard (SFAS) No. 123(R), Share-Based Payment, an amendment of FASB Statements Nos.
123 and 95 (SFAS 123(R)), that addresses the accounting for, among other things, transactions in
which a company receives employee services in exchange for equity instruments of the company. The
statement precludes accounting for employee share-based compensation transactions using the
intrinsic method, and requires that such transactions be accounted for using a fair-value-based
method and that the fair value of the transaction be recognized as expense on a straight-line basis
over the vesting period. In March 2005, the SEC issued Staff Accounting Bulletin (SAB) No. 107
(SAB 107) regarding the Staffs interpretation of SFAS 123(R). This interpretation provides the
Staffs views regarding interactions between SFAS 123(R) and certain SEC rules and regulations and
provides interpretations of the valuation of share-based payments for public companies.
Effective January 1, 2006, the Company adopted the fair value recognition provision of SFAS
123(R) using the modified- prospective method. Under this method, compensation for all share based
payments granted prior to, but not yet vested as of January 1, 2006, based on the grant date fair
value estimated in accordance with the original
6
provisions of SFAS 123(R), Accounting for Stock-based Compensation (123(R)), and
compensation cost for all share-based payments granted subsequent to January 1, 2006, based on the
grant-date fair value estimated in accordance with the provisions of SFAS 123(R), is recognized as
an expense in the first nine-months of 2006. Such amounts have been reduced by the Companys
estimate of forfeitures of all unvested awards. Results for prior periods have not been restated to
retrospectively apply SFAS No. 123(R).
Prior to January 1, 2006, the Company accounted for its stock based compensation plans under
the recognition and measurement provisions of Accounting Principles Board No. 25, Accounting for
Stock Issued to Employees (APB 25), and related interpretations for all awards granted to
employees. Under APB 25, when the exercise price of options granted to employees under these plans
equals the market price of the common stock on the date of grant, no compensation expense is
recorded. When the exercise price of options granted to employees under these plans is less than
the market price of the common stock on the date of grant, compensation expense is recognized over
the vesting period.
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 EITF
96-18, as amended, 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 stock options paid to
non-employees is generally recognized in the period during which services are rendered by such
non-employees. Since our adoption of SFAS 123(R), there been no change to our equity plans or
modifications of our outstanding stock-based awards.
Deferred compensation for non-employee option grants that do not vest immediately upon grant
are recorded as an expense over the vesting period of the underlying stock options, using the
method prescribed by FASB Interpretation 28. At the end of each financial reporting period prior to
vesting, the value of these options, as calculated using the Black Sholes option pricing model,
will be re-measured using the fair value of the Companys common stock and deferred compensation
and the non-cash compensation recognized during the period will be adjusted accordingly. Since the
fair market value of options granted to non-employees is subject to change in the future, the
amount of the future compensation expense is subject to adjustment until the stock options are
fully vested. The Company recognized $26,000 and $228,000 of stock based compensation expense
related to non-employee stock options for the three and nine-month periods ended September 30,
2006, respectively.
The following table illustrates the pro forma effect on net loss and net loss per share
assuming the Company had applied the fair value recognition provisions of SFAS 123(R) to options
granted under the Companys stock option plans for the three and nine-month periods ended September
30, 2005. For purposes of this presentation, the value of the options is estimated using a Black
Sholes option-pricing model and recognized as an expense on a straight-line basis over the options
vesting periods.
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, 2005 |
|
|
September 30, 2005 |
|
|
|
|
|
|
|
(restated) |
|
Net loss allocable to common stockholders |
|
$ |
(3,492 |
) |
|
$ |
(12,604 |
) |
Total stock-based employee
compensation expense determined under
fair-value based method for all awards |
|
|
(369 |
) |
|
|
(1,027 |
) |
|
|
|
|
|
|
|
Pro forma net loss |
|
$ |
(3,861 |
) |
|
$ |
(13,631 |
) |
|
|
|
|
|
|
|
Loss per
share, as originally reported (basic and diluted) |
|
$ |
(0.06 |
) |
|
$ |
(0.20 |
) |
|
|
|
|
|
|
|
Loss per
share, as restated (basic and diluted) |
|
$ |
(0.06 |
) |
|
$ |
(0.22 |
) |
|
|
|
|
|
|
|
Loss per share, pro forma (basic and diluted) |
|
$ |
(0.07 |
) |
|
$ |
(0.24 |
) |
|
|
|
|
|
|
|
The fair value of stock options at the date of grant was estimated using the Black-Sholes
option-pricing model, based on the following assumptions: The Companys expected stock price
volatility assumption is based upon the historical daily volatility of our publicly traded stock.
For option grants issued during the nine-month period ended
7
September 30, 2006 the Company used a calculated volatility for each grant. The expected life
assumptions is 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, the
Company has estimated an annualized forfeiture rate of 10% for
options granted to its employees and 3% for its senior management and
director stock options. 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 $379,000 and $1,075,000 of stock-based compensation for the three and
nine-month periods ended September 30, 2006, respectively. No amounts relating to employee
stock-based compensation have been capitalized.
|
|
|
|
|
|
|
|
|
|
|
Nine-Months Ended |
|
|
September 30, 2006 |
|
September 30, 2005 |
Risk-free interest rate |
|
|
4.27% - 5.23 |
% |
|
|
3.63% - 4.33 |
% |
Expected volatility |
|
|
111.1 |
% |
|
|
131.0 |
% |
Expected lives (years) |
|
|
6 |
|
|
|
6 |
|
Expected dividend yield |
|
|
0.00 |
% |
|
|
0.00 |
% |
At September 30, 2006, there remained approximately $3.5 million of unrecognized compensation
expense related to unvested employee stock options to be recognized as expense over a
weighted-average period of 8.64 years. Presented below is the Companys stock option activity:
|
|
|
|
|
|
|
|
|
|
|
Stock Options |
|
|
Nine-Months Ended |
|
|
September 30, 2006 |
|
|
|
|
|
|
Weighted Average |
|
|
Number |
|
Exercise Price |
|
|
of Shares |
|
per Share |
Outstanding at beginning of year |
|
|
6,205,542 |
|
|
$ |
1.71 |
|
Granted |
|
|
971,500 |
|
|
$ |
1.27 |
|
Exercised |
|
|
(62,500 |
) |
|
$ |
0.96 |
|
Forfeited |
|
|
(152,500 |
) |
|
$ |
2.00 |
|
|
|
|
|
|
|
|
|
|
Outstanding at end of year |
|
|
6,962,042 |
|
|
$ |
1.65 |
|
|
|
|
|
|
|
|
|
|
Shares exercisable at end of period |
|
|
4,465,683 |
|
|
$ |
1.79 |
|
|
|
|
|
|
|
|
|
|
A summary of the activity for nonvested stock options as of September 30, 2006 and changes
during the nine-month period is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Number |
|
Grant Date Fair |
|
|
of Shares |
|
Value per Share |
Nonvested at January 1, 2006 |
|
|
2,767,385 |
|
|
$ |
1.47 |
|
Granted |
|
|
971,500 |
|
|
$ |
1.25 |
|
Vested |
|
|
(1,242,526 |
) |
|
$ |
1.45 |
|
|
|
|
|
|
|
|
|
|
Nonvested at September 30, 2006 |
|
|
2,496,359 |
|
|
$ |
1.39 |
|
|
|
|
|
|
|
|
|
|
8
The following table summarizes significant ranges of outstanding stock options under the three
plans at September 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
|
|
|
Number of |
|
|
|
|
Range of |
|
|
|
|
|
Contractual Life |
|
Weighted Average |
|
Options |
|
Weighted Average |
|
Weighted Average |
Exercise Prices |
|
Number of Options |
|
(years) |
|
Exercise Price |
|
Exercisable |
|
Contractual Life |
|
Exercise Price |
$0.25 1.00
|
|
|
1,236,043 |
|
|
|
7.67 |
|
|
$ |
0.82 |
|
|
|
622,898 |
|
|
|
7.03 |
|
|
$ |
0.82 |
|
$1.01 1.50
|
|
|
1,825,500 |
|
|
|
8.96 |
|
|
|
1.25 |
|
|
|
844,115 |
|
|
|
6.40 |
|
|
|
1.24 |
|
$1.51 2.00
|
|
|
2,237,500 |
|
|
|
7.32 |
|
|
|
1.86 |
|
|
|
1,495,837 |
|
|
|
6.69 |
|
|
|
1.86 |
|
$2.01 3.00
|
|
|
1,662,999 |
|
|
|
6.86 |
|
|
|
2.43 |
|
|
|
1,502,834 |
|
|
|
6.76 |
|
|
|
2.44 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,962,042 |
|
|
|
7.70 |
|
|
$ |
1.65 |
|
|
|
4,465,683 |
|
|
|
6.71 |
|
|
$ |
1.79 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate intrinsic value of outstanding options as of September 30, 2006, was $674,000 of
which $325,000 is related to exercisable options. The aggregate intrinsic value was calculated
based on the positive difference between the closing fair market value of the Companys common
stock on September 30, 2006 ($1.27) and the exercise price of the underlying options. The intrinsic
value of options exercised was $0 and $55,550 for the three and nine-month periods ended September
30, 2006 and the intrinsic value of options vested was $78,000 and $158,000 during these same
periods.
5. Liquidity and Capital Resources
Based on the Companys currently planned level of expenditures, it believes that it will have
adequate working capital to allow it to operate at its currently planned levels through the fourth
quarter of 2008.
In August 2006, the Company received approximately $24.5 million in marketable securities
(which were sold by the Company for approximately $24.3 million in cash) from the privately-funded
ALS Charitable Remainder Trust in exchange for a one percent royalty in the worldwide sales of
arimoclomol. The Company retains the right to market arimoclomol for indications other than ALS
without paying a royalty. The royalty agreement provides that the proceeds of the transaction are
non-refundable and will be used by the Company to continue development of arimoclomol and other
potential treatments for ALS, and that the ALS Charitable Remainder Trust has no obligation to
provide any further funding to the Company. Management has recorded this as service revenue
consistent with the contractual services tenants of SFAS No. 68, Research and Development
Arrangements, using the proportional performance method of revenue recognition, meaning that
service revenue is incurred as a percentage of actual expense. As of September 30, 2006, the
Company recognized approximately $775,000 of service revenue related to this transaction.
We believe that the $24.5 million received from the ALS Charitable Remainder Trust in August
2006 together with the $12.4 million equity financing (net of expenses) that we completed in March
2006, that we have adequate working capital to support our currently planned level of operations
through the fourth quarter of 2008, including our current and planned clinical trials for
arimoclomol and drug discovery efforts related to additional product candidates. Included in our
planned expenses are approximately $0.7 million for our Phase II clinical program with arimoclomol
for ALS during the remainder of 2006, and an additional $4.9 million in 2007 and $18.8 million in
2008 and beyond. The cost of our clinical program for ALS, which we estimate will total
approximately $30.6 million from inception to completion, could vary significantly from our current
projections due to any additional requirements imposed by the FDA in connection with our clinical
program, or if actual costs are higher than current management estimates for other reasons. 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.
The Company will be required to obtain significant additional funding in order to execute its
long-term business plans. The Company plans to evaluate several potential sources of capital,
including potential strategic alliances, although it does not currently have commitments from any
third parties to provide it with capital.
6. Equity Transactions
On March 2, 2006, the Company completed a $13.4 million private equity financing in which it
issued 10,650,794 shares of its common stock and warrants to purchase an additional 5,325,397
shares of its common stock at an exercise price of $1.54 per share. Net of investment banking
commissions, legal, accounting and other expenses related to the transaction, we received proceeds
of approximately $12.4 million.
9
In connection with the 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 March equity financing, the Company entered into a registration rights
agreement with the purchasers of its stock and warrants, which provides, among other things, for
cash penalties in the event that the Company were unable to initially register, or maintain the
effective registration of, the securities. The Company evaluated the penalty provisions in light of
EITF 00-19, Accounting for Derivative Financial Instruments Indexed To, and Potentially Settled In
a Companys Own Stock, and determined that the maximum penalty does not exceed the difference
between the fair value of a registered share of CytRx common stock and unregistered share of Cytrx
common stock on the date of the transaction. Further, the Companys management evaluated the other
terms of the March 2006 financing with the provisions of EITF 00-19 and related accounting
literature. Management concluded based upon its analysis of EITF 00-19 and related accounting
literature, the common stock and related warrants sold in the March 2006 financing should be
recorded as permanent equity in its financial statements.
During the nine-month period ended September 30, 2006, the Company issued 683,903 shares of
its common stock and received $339,193 upon the exercise of stock options and warrants. The Company
did not issue any shares of its common stock and did not receive any proceeds upon the exercise of
stock options or warrants in the three-month period ended September 30, 2006. In addition to the
warrants issued in the March 2006 financing described above, the Company issued 418,000 and 971,500
options in the three and nine-month periods ended September 30, 2006.
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-K, as well as those made in other filings with the SEC.
All statements in this Quarterly Report, including in Managements Discussion and Analysis of
Financial Condition and Results of Operations, other than statements of historical fact are
forward-looking statements for purposes of these provisions, including any projections of financial
items, any statements of the plans and objectives of management for future operations, any
statements concerning proposed new products or services, any statements regarding future economic
conditions or performance, and any statement of assumptions underlying any of the
foregoing. 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 and in documents
incorporated by this Quarterly Report 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.
10
Our future financial condition and results of operations, as well as any forward-looking
statements, are subject to inherent risks and uncertainties, including but not limited to the risk
factors set forth under the heading Risk Factors in this Quarterly Report. These risks and
uncertainties include: the risk that the results and achievements described herein related to our
clinical testing of our drug candidate arimoclomol for the treatment of amyotrophic lateral
sclerosis (ALS or Lou Gehrigs disease) may not be supported by further analysis of the Phase IIa
trial data or by the results of any subsequent clinical trials; uncertainties related to the scope
of the clinical testing that may be required by regulatory authorities for our molecular chaperone
co-induction drug candidates, including arimoclomol, our HIV vaccine candidate and our other
product candidates, and the outcomes of those tests; uncertainties related to the early stage of
our diabetes, obesity, cytomegalovirus, or CMV, and ALS research; the need for future clinical
testing of any small molecules and products based on ribonucleic acid interference, or RNAi, that
may be developed by us; the significant time and expense that will be incurred in developing any of
the potential commercial applications for our small molecules or RNAi technology; risks or
uncertainties related to the sufficiency of our existing cash and cash equivalents to meet our
projected cash requirements and our ability to obtain capital to fund our ongoing working capital
needs, including capital required to fund RNAi development activities that we plan to conduct
through the creation of a new subsidiary; and risks relating to the enforceability of any patents
covering our products and to the possible infringement of third party patents by those products.
All forward-looking statements and reasons why results may differ included in this Quarterly
Report are made as of the date hereof, and we assume no obligation to update any such
forward-looking statement or reason why actual results might differ.
Overview
We are a biopharmaceutical research and development company, based in Los Angeles, California,
with an obesity and type 2 diabetes research laboratory in Worcester, Massachusetts. We are in the
process of developing products, primarily in the areas of small molecule therapeutics and
ribonucleic acid interference, or RNAi, for the human health care market. Our small molecule
therapeutics efforts include clinical development of three oral drug candidates that we acquired in
October 2004, including a Phase II clinical program initiated in September 2005, as well as drug
discovery operations conducted at our laboratory in Worcester, Massachusetts. RNAi is a relatively
recent technology for silencing genes in living cells and organisms, and we are aware of only four
clinical tests of therapeutic applications using RNAi that have been initiated by any party. In
addition to our work in RNAi and small molecule therapeutics, we recently announced that a novel
HIV DNA + protein vaccine exclusively licensed to us and developed by researchers at the University
of Massachusetts Medical School, or UMMS, and Advanced BioScience Laboratories, and funded by the
National Institutes of Health, demonstrated promising interim Phase I clinical trial results that
indicate its potential to produce potent antibody responses with neutralizing activity against
multiple HIV viral strains. We have also entered into strategic alliances with respect to the
development of several other products using our other technologies.
In 2004, we began a development program based on molecular chaperone co-induction technology
through the acquisition of novel small molecules with broad therapeutic applications in neurology,
type 2 diabetes, cardiology and diabetic complications. The acquired assets included three oral,
clinical stage drug candidates and a library of 500 small molecule drug candidates. In September
2005, we entered the clinical stage of drug development with the initiation of a Phase II clinical
program with our lead small molecule product candidate arimoclomol for the treatment of amyotrophic
lateral sclerosis (ALS or Lou Gehrigs disease). Arimoclomol has received Orphan Drug and Fast
Track designation from the U.S. Food and Drug Administration, or FDA.
The initial Phase II clinical trial that we recently completed for arimoclomol for ALS (which
we refer to as the Phase IIa trial) was a multicenter, double-blind, placebo-controlled study of
approximately 80 ALS patients enrolled at ten clinical centers across the U.S. Patients received
either placebo (a capsule without drug), or one of three dose levels of arimoclomol capsules three
times daily, for a period of 12 weeks. This treatment phase was followed by a one-month period
without drug. The primary endpoints of this Phase IIa trial were safety and tolerability. Secondary
11
endpoints included a preliminary evaluation of efficacy using two widely accepted surrogate
markers, the revised ALS Functional Rating Scale (ALSFRS-R), which were used to determine patients
capacity and independence in 13 functional activities, and Vital Capacity (VC), an assessment of
lung capacity. The trial was powered to monitor only extreme responses in these two categories.
In September 2006, we announced results of the Phase IIa trial for arimoclomol for ALS,
reporting that arimoclomol had met the trials primary endpoints of safety and tolerability at all
three doses tested, and that the trial results indicated a non-statistically-significant trend of
improvement in functional capacity as measured by the Revised ALS Functional Ration Scale in the
arimoclomol high dose group as compared with untreated patients.
We have also announced initiation of an open-label (i.e., the medication is no longer
blinded to the patients or their doctor) extension of this clinical trial. Patients who completed
the Phase IIa study and who still met the eligibility criteria were given the opportunity to take
arimoclomol, at the highest investigative dose, for as long as an additional 6 months. We
anticipate completing the open label extension of the trial in the first quarter of 2007.
We plan to initiate a subsequent Phase II trial (which we refer to as the Phase IIb trial)
that will be powered to detect more subtle efficacy responses in the third quarter of 2007.
Although this second trial is still in the planning stages and will be subject to FDA approval, it
is expected to include approximately 400 ALS patients recruited from approximately 30 clinical
sites, and will take approximately 18 months after initiation to complete.
Our molecular chaperone co-induction technology represents a continuation of our business
strategy, adopted subsequent to our merger with Global Genomics, in July 2002, to conduct further
research and development efforts for our pre-merger adjuvant and co-polymer technologies, including
Flocor and Tranzfect, through strategic relationships with other pharmaceutical companies, and to
focus our efforts on acquiring and developing new technologies and products to serve as the
foundation for the future of the company.
In April 2003, we acquired our first new technologies by entering into exclusive license
agreements with UMMS covering potential applications for its proprietary RNAi technology in the
treatment of specified diseases and in the identification and screening of novel protein targets.
In May 2003, we broadened our strategic alliance with UMMS by acquiring an exclusive license from
it covering a proprietary DNA-based HIV vaccine technology. In July 2004, we further expanded our
strategic alliance with UMMS by entering into a collaboration and invention disclosure agreement
with UMMS under which UMMS will disclose to us certain new technologies developed at UMMS over a
three-year period pertaining to RNAi, diabetes, obesity, neurodegenerative diseases (including ALS)
and CMV, and will give us an option, upon making a specified payment, to negotiate an exclusive
worldwide license to the disclosed technologies on commercially reasonable terms. Approximately
nine months remain on the technology disclosure option. As part of our strategic alliance with
UMMS, we agreed to fund certain discovery and pre-clinical research at UMMS relating to the use of
our technologies, licensed from UMMS, for the development of therapeutic products within certain
fields.
In conjunction with some of our work with UMMS, we operate a research and development
laboratory in Worcester, Massachusetts whose goal is to develop small molecule and RNAi-based
therapeutics for the prevention, treatment and cure of obesity and type 2 diabetes. This laboratory
is focusing on using our proprietary RNAi gene silencing technology, combined with genomic and
proteomic based drug discovery technologies, to accelerate the process of screening and identifying
potential proprietary drug targets and pathways for these diseases. Through this laboratory, we are
seeking to develop orally active drugs against promising targets and pathways relevant to obesity
and type 2 diabetes. We are currently pursuing a plan, subject to obtaining necessary funding, to
transfer all of our
RNAi-related programs into a newly-formed subsidiary to accelerate the development and
commercialization of drugs based on RNAi technology.
Although we intend to internally fund the early stage development work for certain product
applications (including obesity, type 2 diabetes and ALS) and may seek to fund the completion of
the development of certain of these product applications (such as arimoclomol for ALS), we may also
seek to secure strategic alliances or license
12
agreements with larger pharmaceutical or
biotechnology companies to fund the early stage development work for other gene silencing product
applications and for subsequent development of those potential products where we fund the early
stage development work.
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 activities related to our collaborations, technology acquisitions, ongoing
and planned clinical trials, research and development programs and other general corporate
activities. We anticipate that our 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.
To date, we have relied primarily upon sales of equity securities and a sale of a royalty
interest in arimoclomol and, to a much lesser extent, upon payments from our strategic partners and
licensees and upon proceeds received upon the exercise of options and warrants, to generate the
funds needed to finance our business plans and operations. We will be required to obtain
significant additional funding in order to execute our long-term business plans. Our sources of
potential funding for the next several years are expected to consist primarily of proceeds from
sales of equity, but could also include license and other fees, funded research and development
payments, gifts and grants, and milestone payments under existing and future collaborative
arrangements. However, we have no commitment or arrangements for such additional funding.
Restatement
The accompanying condensed financial statements have been restated to reflect a
reclassification of certain expenses related to the operations of our Massachusetts laboratory and
a correction of the accounting for our historical anti-dilution adjustments in certain of its
outstanding warrants. The statement of operations was restated to include deemed dividends of
$1,075,568 and $488,429 in the first quarters of 2005 and 2006, respectively, in arriving at the
net loss applicable to common stockholders of $12,603,663 and $13,092,287 for the nine-month
periods ended September 30, 2005 and 2006, respectively. The restated net loss applicable to
common stockholders resulted in an increase in net loss per share from $0.20 to $0.22 for the
nine-month period ended September 30, 2005, but did not change the net loss per share of $0.19 for
the same period in 2006. The statement of operations was also
restated to reflect $434,599 and $1,316,721 of
expenses that were reclassified from general and administrative expense to research and development
expense for the three and nine-month periods ended September 30,
2006, respectively.
Critical Accounting Policies and Estimates
Managements discussion and analysis of our financial condition and results of operations are
based on our consolidated financial statements, which have been prepared in accordance with
accounting principles generally accepted in the United States. The preparation of these financial
statements requires management to make estimates and judgments that affect the reported amounts of
assets, liabilities, revenue and expenses, and related disclosure of contingent assets and
liabilities. On an ongoing basis, management evaluates its estimates, including those related to
revenue recognition, bad debts, impairment of long-lived assets, including finite lived intangible
assets, accrued liabilities and certain expenses. We base our estimates on historical experience
and on various other assumptions that are believed to be reasonable under the circumstances, the
results of which form the basis for making judgments about the carrying values of assets and
liabilities that are not readily apparent from other sources. Actual results may differ materially
from these estimates under different assumptions or conditions.
Our significant accounting policies are summarized in Note 2 to our financial statements
contained in our Annual Report on Form 10-K filed for the year ended December 31, 2005. 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
Nonrefundable license fee revenue is recognized when collectibility is reasonably assured,
which is generally upon receipt, and no continuing involvement on our part is required and payment
of the license fee represents the culmination of the earnings process. Nonrefundable license fees
received subject to future performance by us or that are credited against future payments due to us
are deferred and recognized as services are performed and collectibility is reasonably assured,
which is generally upon receipt, or upon termination of the agreement and all
related obligations thereunder, whichever is earlier. Our revenue recognition policy may
require us to defer significant amounts of future revenue.
In August 2006, the Company received approximately $24.5 million in marketable securities
(which were sold by the Company for approximately $24.3 million in cash) from the privately-funded
ALS Charitable Remainder Trust (ALSCT) 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
13
arrangement, the Company retains the rights to any
developments funded by the arrangement and the proceeds of the transaction are non-refundable.
Further, the ALS Charitable Remainder Trust has no obligation to provide any further funding to the
Company. Management has analyzed the transaction and concluded that due to the research and
development components of the transaction that it is properly accounted for under SFAS No. 68,
Research and Development Arrangements (SFAS No. 68). Accordingly, the Company has recorded the
value received under the arrangement as deferred service revenue and will recognize service revenue
using the proportional performance method of revenue recognition, meaning that service revenue is
recognized as a percentage of actual research and development expense. As of September 30, 2006,
the Company recognized approximately $775,000 of service revenue related to this transaction.
Research and Development Expenses
Research and development expenses consist of costs incurred for direct and overhead-related
research expenses and are expensed as incurred. Costs to acquire technologies which are utilized in
research and development and which have no alternative future use are expensed when incurred.
Technology developed for use in our products is expensed as incurred, until technological
feasibility has been established. Expenditures, to date, have been classified as research and
development expense in the consolidated statements of operations, and we expect to continue to
expense research and development for the foreseeable future.
Stock-based Compensation
Effective January 1, 2006, we adopted the provisions of SFAS 123(R), Share-Based Payment
(SFAS 123(R)), which revises SFAS No. 123, Accounting for Stock-Based Compensation, and
supersedes Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees.
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. The pro forma disclosures previously permitted under SFAS 123(R) are no
longer an alternative to financial statement recognition. We are using the modified-prospective
method and the Black-Scholes valuation model for valuing the share-based payments. We will continue
to account for transactions in which services are received in exchange for equity instruments based
on the fair value of such services received from non-employees, in accordance with SFAS 123(R) and
Emerging Issues Task Force (EITF) Issue No. 96-18, Accounting for Equity Instruments that Are
Issued to Other than Employees for Acquiring, or in Conjunction with Selling, Goods or Services.
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.
Facility Abandonment
During 2005, we entered into a termination agreement related to the lease for our former
Atlanta headquarters. Pursuant to this agreement, we were released from all future obligations on
the lease in exchange for a one-time $110,000 payment and the forfeiture of a $49,000 security
deposit. As a result of this agreement, we realized a $164,000 offset against our 2005 third
quarter general and administrative expenses.
14
Liquidity and Capital Resources
At September 30, 2006, we had cash and cash equivalents of $33.7 million and total assets of
$35.1 million, compared to $8.3 million and $9.9 million, respectively, at December 31, 2005.
Working capital totaled $31.5 million at September 30, 2006, compared to $6.3 million at December
31, 2005.
To date, we have relied primarily upon sales of equity securities and a sale of a royalty
interest in arimoclomol and, to a much lesser extent, payments from our strategic partners and
licensees and upon proceeds received upon the exercise of options and warrants, to generate funds
needed to finance our business and operations. As a result of the $12.4 million equity financing
(net of expenses) that we completed in March 2006 and our execution of the royalty and research and
development agreement for $24.5 million of marketable securities (which were converted into
approximately $24.3 million in cash) to the privately-funded ALS Charitable Remainder Trust of a
one percent royalty interest in worldwide sales of arimoclomol for ALS, we believe that we have
adequate working capital to support our currently planned level of operations through the fourth
quarter of 2008, including our current and planned clinical trials for arimoclomol and drug
discovery efforts related to additional product candidates. Included in our planned expenses are
approximately $0.7 million for our Phase II clinical program with arimoclomol for ALS during the
remainder of 2006, and an additional $4.9 million in 2007 and $18.8 million in 2008 and beyond. The
cost of our clinical program for ALS, which we estimate will total approximately $30.6 million from
inception to completion, could vary significantly from our current projections due to any
additional requirements imposed by the FDA in connection with our clinical program, or if actual
costs are higher than current management estimates for other reasons. 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, our planned levels of operations for our obesity and type 2 diabetes research
laboratory and our ongoing research and development efforts related to our other small molecule
drug candidates, and in order to continue to meet our obligations to UMMS. Additionally, we expect
to spend approximately an additional $150,000 related to our efforts to comply with the
requirements of Section 404 of the Sarbanes Oxley Act of 2002 during the fourth quarter of 2006.
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.
In the nine-month periods ended September 30, 2006 and 2005, net cash used in investing
activities consisted of approximately $82,000 and $39,000, respectively, for the purchase of
equipment. We expect capital spending during the fourth quarter to be comparable to the first three
quarters of 2006.
Cash provided by operating activities included $24.5 million in marketable securities (which
were sold by the Company for approximately $24.3 million in cash) received upon the execution of
the royalty and research and development agreement with the privately-funded ALS Charitable
Remainder Trust of a one percent royalty in the worldwide sales of arimoclomol less the royalty
revenue recognized during the third quarter of $775,000. The royalty agreement provides that the
proceeds of the transaction will be used by the Company to continue development of arimoclomol and
other potential treatments for ALS.
Cash provided by financing activities in the nine-month period ended September 30, 2006 was
$12.7 million. The cash provided includes approximately $339,000 received from the exercise of
stock options and warrants.
Additionally, we received approximately $12.4 million, net of expenses, through a private
equity financing that closed in March 2006. Cash provided by financing activities in the nine-month
period ended September 30, 2005 was $19.8 million. During that period, we raised $19.6 million, net
of expenses,- from the issuance of common stock in a private equity financing in January 2005, and
we received proceeds from the exercise of stock options and warrants totaling $252,000.
15
Our net loss for the nine-month period ended September 30, 2006 was $12.6 million, which
resulted in net cash provided from operating activities of $12.7 million. Adjustments to reconcile
net loss to net cash provided from operating activities for the nine-month period ended September
30, 2006 were primarily $1.1 million from the employee stock option expense incurred related to our
implementation of SFAS 123(R); $228,000 of common stock, options and warrants expense issued in
lieu of cash for general and administrative services and research and development services,
respectively, and $192,000 of depreciation and amortization expense, which was off-set by a $23.8
million change in operating assets and liabilities (including the $24.3 million of deferred revenue
received upon the sale of a royalty interest to the ALS Charitable Remainder Trust less the royalty
revenue recognized of $775,000). Our net loss for the nine-month period ended September 30, 2005
was $11.5 million, which resulted in net cash used in operating activities of $11.6 million.
Adjustments to reconcile net loss to net cash used in operating activities for the nine-month
period ending September 30, 2005 include $485,000 of common stock, options and warrants issued in
lieu of cash for research and development and selling, general and administrative services, as well
as a net change in assets and liabilities of $462,000, the recording of $158,000 depreciation and
amortization expense, $81,000 of minority interest and $163,000 gain on the termination of the
Atlanta lease.
We believe that we have adequate working capital to allow us to operate at our currently
planned levels through the fourth quarter of 2008. Our strategic alliance with UMMS may require us
to make significant expenditures to fund research at UMMS relating to developing therapeutic
products based on UMMSs proprietary gene silencing technology that has been licensed to us. The
aggregate amount of these expenditures during 2006 was approximately $1.0 million; all of which had
been expensed through September 30, 2006. At this time, we have no future commitments to fund
research, however we are in discussions regarding future licensing and commitments.
We will require significant additional capital in order to fund the completion of our clinical
program with our lead small molecule product candidate arimoclomol for the treatment of ALS, which
commenced in September 2005, and the other ongoing research and development related to our other
molecular chaperone co-induction drug candidates. We incurred $3.4 million on the arimoclomol
clinical program in the first nine months of 2006, and we estimate that the overall program,
including the ongoing open label trial and the planned Phase IIb trial that we expect to initiate
in 2007 subject to FDA approval, will require us to expend an additional $0.7 million in the
remainder of 2006, and an additional $23.7 million for 2007 and beyond. However, we may incur
substantial additional expense and the trial may be delayed if the FDA requires us to generate
additional pre-clinical or clinical data in connection with the clinical trial, or the FDA requires
us to revise significantly our planned protocol for the Phase IIb.
Additional capital may be provided by potential milestones payments pursuant to our license
with Vical, which relates to Tranzfect, or our license with SynthRx related to Flocor, or by
potential payments from future strategic alliance partners or licensees of our technologies. As
Vical is currently only in Phase II development of a product using TransFect it is likely to be a
substantial period of time, if ever, before we receive any further significant payments from Vical.
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.
16
Results of Operations
We recorded a net loss of $3.0 and $12.6 million for the three and nine-month periods ended
September 30, 2006, respectively, as compared to $3.5 million and $11.5 million for the same
periods in 2005.
We recognized $775,000 of revenue from our $24.5 million sale of marketable securities (which
were sold by the Company for approximately $24.3 million in cash) to the ALS Charitable Remainder
Trust of a royalty interest in worldwide sales of arimoclomol, and earned an immaterial amount of
service revenue during the three and nine-month periods ended September 30, 2006. We earned an
immaterial amount of licensing fees during the three and nine-month periods ended September 30,
2005. All future licensing fees under our current licensing agreements are dependent upon
successful development milestones being achieved by the licensor. During fiscal 2006, we are not
anticipating receiving any significant 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 life of our arimoclomol research (the development period).
In 2006, we expect our research and development expenses to increase primarily as a result of
our ongoing Phase II clinical program with arimoclomol and related studies for the treatment of
ALS. We incurred $3.4 million on the arimoclomol clinical program in the first nine months of 2006,
and we estimate that the overall program, including the ongoing open label trial and the planned
Phase IIb trial that we expect to initiate subject to FDA approval, will require us to expend an
additional $0.7 million in the remainder of 2006, and an additional $23.7 million for 2007 and
beyond. Additionally, we estimate that our costs related to the activities of our Massachusetts
laboratory will remain consistent with 2005 expenditures.
Research and development expenses were $1.6 million and $6.8 million, respectively, during the
three and nine-month periods ended September 30, 2006, as compared to $2.0 million and $6.8 million
for the same periods in 2005. Research and development expenses incurred during the first nine
months of 2006 and 2005 related primarily to (i) the preparation for and initiation of our Phase II
clinical program for arimoclomol in ALS, (ii) our ongoing research and development related to our
other molecular chaperone co-induction drug candidates, (iii) our research and development
activities conducted at UMMS related to the technologies covered by the UMMS license agreements,
(iv) our collaboration and invention disclosure agreement pursuant to which UMMS has 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 on-going small molecule drug
discovery operations at our Massachusetts laboratory. Although our future research and development
activities could vary substantially, our research and development activities will remain
substantial in the future as a result of commitments related to the foregoing activities.
In each of the periods presented in the accompanying condensed consolidated statements of
operations, certain vesting criteria of stock options issued to consultants were achieved,
resulting in aggregate non-cash charges for research and development activities of $92,000 and
$197,000 during the three and nine-month periods ended September 30, 2006 and $32,000 and $122,000
for the same periods ended September 30, 2005.
All research and development costs related to the activities of our laboratory are expensed.
No in-process research and development costs were eligible for capitalization at the time we
purchased the minority interest in our prior subsidiary, CytRx Laboratories.
Depreciation and amortization expense was $53,000 and $192,000 during the three and nine-month
periods ended September 30, 2006, as compared to $58,000 and $158,000 for the same periods in 2005.
The amounts in 2006 and 2005 primarily relate to depreciation of fixed assets located at our
Massachusetts laboratory and the amortization of the molecular screening library acquired in 2004,
which was put into service in March of 2005.
From time to time, we issue shares of our common stock or options and warrants 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, or warrants at
the fair market value of the common stock,
17
stock options or warrants granted, or the services
received, whichever is more reliably measurable, and we recognize the expense in the period in
which a performance commitment exists or the period in which the services are received, whichever
is earlier. During each of the periods presented in the accompanying condensed consolidated
statements of operations, certain vesting criteria of stock options and warrants issued to
consultants were achieved, resulting in aggregate non-cash charges for general and administrative
activities of $(66,000) and $32,000 for the three and nine-month periods ended September 30, 2006,
respectively, and $26,000 and $342,000 for the three and nine-month periods ended September 30,
2005. In addition, for the nine-month period ended September 30, 2006, we recorded $1,075,000 of
employee stock option expense in accordance with SFAS 123(R), for which there was no corresponding
expense recorded in prior periods.
General and administrative expenses incurred were $1.9 and $5.8 million for the three and
nine-month periods ended September 30, 2006, as compared to $1.5 and $4.8 million for the same
periods in 2005. The expenses incurred during the three and nine-month periods ended September 30,
2006 were higher in the third quarter due to increases in salary and benefits of $117,000 and
professional fees of $330,000. We anticipate general and administrative expenses to increase over
the remainder of 2006 as a result of, among other things, our efforts to comply with the
requirements of Section 404 of the Sarbanes Oxley Act of 2002, and continuing employee stock option
expense as a result of our implementation of SFAS 123(R).
Interest income was $296,000 and $580,000 for the three and nine-month periods ended September
30, 2006, as compared to $40,000 and $124,000 for the same period in 2005. The increase in interest
income was due to the larger balances maintained and the higher rates on our cash and investments
that were held during 2006 compared to the lower rates in the same period in 2005.
For 2006, we did not record any minority interest share of our losses because, on September
30, 2005, we repurchased the outstanding 5% interest in CytRx Laboratories from Dr. Michael Czech,
and on September 30, 2005, we completed our merger with CytRx Laboratories. For the Nine-Months
ended September 30, 2005, we recorded a $81,000 reduction to our losses as a result of the minority
interest share in the losses of CytRx Laboratories. This amount is reported as a separate line item
in the accompanying condensed consolidated statements of operations.
Related Party Transactions
Dr. Michael Czech, a 5% minority shareholder of CytRx Laboratories until September 30, 2005
and a member of our Scientific Advisory Board, is an employee of UMMS and is the principal
investigator for a sponsored research agreement between CytRx and UMMS. During the nine-month
periods ended September 30, 2006 and 2005, we incurred expenses to UMMS related to Dr. Czechs
sponsored research agreement of $201,000 and $604,000, respectively. Additionally, we paid $60,000
to Dr. Czech for his services on the Scientific Advisory Board for each of these periods.
Item 4 Controls and Procedures
Evaluations of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial
Officer, performed an evaluation of the effectiveness of the design and operation of our disclosure
controls and procedures (as defined in Securities Exchange Act Rule 13a-15(e)) as of September 30,
2006, the end of the period covered by our original Form 10-Q. Based on that evaluation, our Chief
Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures
were effective to ensure that information required to be disclosed by us in reports
that we file or submit under the Securities Exchange Act of 1934 is recorded, processed,
summarized and reported within the time periods specified in the rules and forms of the SEC. 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.
18
Subsequently, in conjunction with the preparation of our Annual Report on Form 10-K for the
year ended December 31, 2006, our management, with the participation of our Chief Executive Officer
and Chief Financial Officer, identified other deficiencies, discussed below, that it considered to
be material weaknesses (a) in the effectiveness of our internal controls over financial reporting
related to the application of generally accepted accounting principles arising from our accounting
for historical warrant anti-dilution adjustments as deemed dividends, and (b) in the effectiveness
of our internal controls over quarterly and annual financial statement reporting arising from our
accounting for research and development expenses related to our laboratory facility in Worcester,
Massachusetts. Pursuant to standards established by the Public Company Accounting Oversight Board,
a material weakness is a significant deficiency or combination of significant deficiencies that
results in more than a remote likelihood that a material misstatement of the annual or interim
financial statements will not be presented or detected.
In May and September of 2003, we completed private placements of securities that included
warrants to purchase approximately 2.8 million shares of our common stock. These warrants contain
provisions for anti-dilution adjustments based upon future sales of our common stock or common
stock equivalents at an effective price per share below the prevailing market price of our common
stock at the time of the sale. We subsequently completed private placement transactions in January
2005 and in March 2006 involving our sale of securities at prices which triggered the foregoing
anti-dilution adjustments to the warrants in question, and we recorded those adjustments as deemed
dividends. Based upon a reevaluation of our historical accounting for those anti-dilution
adjustments, management determined that, by analogy to the guidance provided by SFAS No. 128,
Earnings Per Share, the deemed dividends should be subtracted from our net earnings (loss) (i.e.,
added to our net loss) to arrive at net loss allocable to common stockholders and for the purpose
of calculating our net earnings (loss) per share.
In addition, until the third quarter of 2005, our laboratory facility was operated by our
subsidiary, CytRx Laboratories, Inc. (CytRx Labs). CytRx Labs maintained a separate accounting
system, although the general ledger accounts in its system and our accounting system were
identically numbered. On September 30, 2005, CytRx Labs was merged into CytRx, and we continued to
operate the laboratory as an integrated part of CytRx.
In the first quarter of 2006, for the sake of administrative efficiency, CytRx Labs general
ledger system was integrated into our general ledger system by combining the laboratorys general
ledger accounts with our identically numbered accounts. In the process, expenses of the laboratory
relating to rent, payroll and related employee benefits, which should properly have been classified
as research and development expenses due to the nature of our activities carried on at the
laboratory, were improperly classified as general and administrative expenses and reported as such
on the original Form 10-Q, because they were combined with corresponding accounts of CytRx, whose
corporate offices and personnel are devoted primarily to administrative activities.
Based on that evaluation of the effectiveness of the design and operation of our disclosure
controls and procedures, and solely because of corrections referred to above, our Chief Executive
Officer and Chief Financial Officer concluded that our disclosure controls and procedures over our
accounting for research and development expenses related to our laboratory facility and our
accounting for warrant anti-dilution adjustments were not effective as of June 30, 2006.
The weakness regarding the reclassification of research and development expenses related
specifically to the manner in which we integrated the former separate accounting system of our
laboratory facility. Having completed our review and evaluation of the integration in connection
with the preparation of our annual financial statements for 2006, we believe that the remediation
of this weakness also has been completed. We additionally intend to pursue
additional actions to enhance internal review of all equity transactions to ensure the
effectiveness of all aspects of our controls related to the accounting for anti-dilution
adjustments to our outstanding warrants and other securities.
We 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
19
financial reporting could cause us to fail to meet our
reporting obligations under the Securities and Exchange Commissions rules and regulations. Any
failure to improve our internal controls to address the weakness we have identified could also
cause investors to lose confidence in our reported financial information, which could have a
negative impact on the trading price of our common stock.
20
PART II OTHER INFORMATION
Item 6. Exhibits
The exhibits listed in the accompanying Index to Exhibits are filed as part of this Quarterly
Report on Form 10-Q.
21
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this amendment to be signed on its behalf by the undersigned thereunto duly authorized.
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CYTRX CORPORATION
(Registrant)
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Date: April 2, 2007 |
By: |
/s/ MATTHEW NATALIZIO
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Matthew Natalizio |
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Chief Financial Officer
(Principal Financial Officer) |
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22
INDEX TO EXHIBITS
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Exhibit |
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Number |
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Description |
10.1
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x
|
|
Royalty Agreement dated August 28, 2006 between CytRx Corporation and Kenneth Council, as
Trustee of the ALS Charitable Remainder Trust |
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|
|
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31.1
|
|
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|
Certification of Chief Executive Officer Pursuant to 15 U.S.C. Section 7241, as adopted
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
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|
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31.2
|
|
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Certification of Chief Financial Officer Pursuant to Section 15 U.S.C. Section 7241, as
adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002 |
|
|
|
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|
32.1
|
|
x
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Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
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32.2
|
|
x
|
|
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 |
23