LadRx Corp - Quarter Report: 2008 June (Form 10-Q)
Table of Contents
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2008
OR
o | 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)
Delaware (State or other jurisdiction of incorporation or organization) |
58-1642740 (I.R.S. Employer Identification No.) |
|
11726 San Vicente Blvd., Suite 650 Los Angeles, CA (Address of principal executive offices) |
90049 (Zip Code) |
(310) 826-5648
(Registrants telephone number, including area code)
(Registrants telephone number, including area code)
Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the Registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o | Accelerated filer þ | Non-accelerated filer o (Do not check if a smaller reporting company) |
Smaller reporting company o |
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12(b)-2 of the
Exchange Act). Yes o No þ
Number of shares of CytRx Corporation Common Stock, $.001 par value, issued and outstanding as of
August 6, 2008: 90,770,453, exclusive of treasury shares.
CYTRX CORPORATION
FORM 10-Q
TABLE OF CONTENTS
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PART I FINANCIAL INFORMATION
Item 1. Financial Statements
CYTRX CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
CONDENSED CONSOLIDATED BALANCE SHEETS
June 30, | December 31, | |||||||
2008 | 2007 | |||||||
(Unaudited) | ||||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 36,382,744 | $ | 50,498,261 | ||||
Short-term investments, at amortized cost |
| 9,951,548 | ||||||
Accounts receivable |
29,332 | 101,217 | ||||||
Loan receivable, net of reserve |
1,600,000 | | ||||||
Prepaid expense and other current assets |
1,232,891 | 930,596 | ||||||
Total current assets |
39,244,967 | 61,481,622 | ||||||
Equipment and furnishings, net |
1,703,607 | 1,573,290 | ||||||
Molecular library, net |
148,639 | 193,946 | ||||||
Investment in unconsolidated subsidiary (see Note 9) |
1,344,373 | | ||||||
Goodwill |
183,780 | 183,780 | ||||||
Other assets |
238,387 | 713,398 | ||||||
Total assets |
$ | 42,863,753 | $ | 64,146,036 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 520,363 | $ | 1,946,215 | ||||
Accrued expenses and other current liabilities |
2,262,637 | 3,700,866 | ||||||
Income taxes payable |
342,000 | | ||||||
Deferred revenue, current portion |
6,228,035 | 8,399,167 | ||||||
Total current liabilities |
9,353,035 | 14,046,248 | ||||||
Deferred revenue, non-current portion |
5,417,062 | 7,167,381 | ||||||
Total liabilities |
14,770,097 | 21,213,629 | ||||||
Minority interest |
| 2,708,368 | ||||||
Commitments and Contingencies |
||||||||
Stockholders equity: |
||||||||
Preferred Stock, $.01 par value, 5,000,000 shares
authorized, including 15,000 shares of Series A
Junior Participating Preferred Stock; no shares
issued and outstanding |
| | ||||||
Common stock, $.001 par value, 150,000,000 shares
authorized; 91,404,269 and 90,397,867 shares
issued at June 30, 2008 and December 31, 2007,
respectively |
91,404 | 90,398 | ||||||
Additional paid-in capital |
206,617,383 | 203,905,691 | ||||||
Treasury stock, at cost (633,816 shares held at
June 30, 2008 and December 31, 2007,
respectively) |
(2,279,238 | ) | (2,279,238 | ) | ||||
Accumulated deficit |
(176,335,893 | ) | (161,492,812 | ) | ||||
Total stockholders equity |
28,093,656 | 40,224,039 | ||||||
Total liabilities and stockholders equity |
$ | 42,863,753 | $ | 64,146,036 | ||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
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CYTRX CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2008 | 2007 | 2008 | 2007 | |||||||||||||
Revenue: |
||||||||||||||||
Service revenue |
$ | 1,740,362 | $ | 2,369,513 | $ | 3,921,450 | $ | 3,816,506 | ||||||||
Grant revenue |
| | | 116,070 | ||||||||||||
1,740,362 | 2,369,513 | 3,921,450 | 3,932,576 | |||||||||||||
Expenses: |
||||||||||||||||
Research and development |
2,525,659 | 6,884,296 | 5,717,372 | 10,892,670 | ||||||||||||
General and administrative |
3,192,082 | 4,106,597 | 7,665,231 | 6,591,681 | ||||||||||||
5,717,741 | 10,990,893 | 13,382,603 | 17,484,351 | |||||||||||||
Loss before other income |
(3,977,379 | ) | (8,621,380 | ) | (9,461,153 | ) | (13,551,775 | ) | ||||||||
Other income: |
||||||||||||||||
Interest income |
284,304 | 659,062 | 808,575 | 1,039,676 | ||||||||||||
Other income, net |
1,000 | 1,501,000 | 219,229 | 1,501,000 | ||||||||||||
Equity in loss of unconsolidated subsidiary |
(2,133,956 | ) | | (2,512,854 | ) | | ||||||||||
Minority interest in losses of subsidiary |
| 176,136 | 88,374 | 178,136 | ||||||||||||
Net loss before income taxes |
(5,826,031 | ) | (6,285,182 | ) | (10,857,829 | ) | (10,832,963 | ) | ||||||||
Provision for income taxes |
| | (342,000 | ) | | |||||||||||
Net loss |
(5,826,031 | ) | (6,285,182 | ) | (11,199,829 | ) | (10,832,963 | ) | ||||||||
Deemed dividend for anti-dilution adjustment
made to stock warrants |
| | (756,954 | ) | | |||||||||||
Net loss applicable to common stockholders |
$ | (5,826,031 | ) | $ | (6,285,182 | ) | $ | (11,956,783 | ) | $ | (10,832,963 | ) | ||||
Basic and diluted loss per share |
$ | (0.06 | ) | $ | (0.07 | ) | $ | (0.13 | ) | $ | (0.14 | ) | ||||
Weighted average shares outstanding |
90,768,145 | 85,379,769 | 90,524,297 | 79,242,321 | ||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
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CYTRX CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Six Months Ended June 30, | ||||||||
2008 | 2007 | |||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (11,199,829 | ) | $ | (10,832,963 | ) | ||
Adjustments to reconcile net loss to net used in operating activities: |
||||||||
Depreciation and amortization |
271,960 | 121,067 | ||||||
Equity in loss of unconsolidated subsidiary |
2,512,854 | | ||||||
Minority interest in losses of subsidiary |
(88,374 | ) | (178,136 | ) | ||||
Reserve
against loan receivable |
690,000 | | ||||||
RXi common stock transferred for services |
244,860 | | ||||||
Non-cash earned on short-term investments |
(48,452 | ) | | |||||
Non-cash gain on transfer of RXi common stock |
(226,579 | ) | | |||||
Common stock issued for services |
| 2,310,560 | ||||||
Expense related to employee and non-employee stock options |
1,053,498 | 2,205,919 | ||||||
Net change in operating assets and liabilities |
(4,946,228 | ) | (4,431,803 | ) | ||||
Total adjustments |
(536,461 | ) | 29,607 | |||||
Net cash used in operating activities |
(11,736,290 | ) | (10,803,356 | ) | ||||
Cash flows from investing activities: |
||||||||
Purchases of equipment and furnishings |
(706,757 | ) | (38,303 | ) | ||||
Deconsolidation of subsidiary, RXi Pharmaceutical Corporation |
(10,359,278 | ) | | |||||
Proceeds from sale of short-term investments |
10,000,000 | | ||||||
Loan
receivable |
(2,290,000 | ) | | |||||
Net cash used in investing activities |
(3,356,035 | ) | (38,303 | ) | ||||
Cash flows from financing activities: |
||||||||
Proceeds from exercise of stock options and warrants |
976,808 | 15,909,775 | ||||||
Net proceeds from issuances of common stock |
| 34,248,062 | ||||||
Net cash provided by financing activities |
976,808 | 50,157,837 | ||||||
Net increase (decrease) in cash and cash equivalents |
(14,115,517 | ) | 39,316,178 | |||||
Cash and cash equivalents at beginning of period |
50,498,261 | 30,381,393 | ||||||
Cash and cash equivalents at end of period |
$ | 36,382,744 | $ | 69,697,571 | ||||
Supplemental disclosure of cash flow information: |
||||||||
Cash received during the period as interest income |
$ | 808,575 | $ | 1,039,676 | ||||
Supplemental schedule of non-cash investing and financing activities:
As the result of the March 6, 2008 distribution by CytRx Corporation (the Company) to its
stockholders of approximately 36% of the outstanding shares of RXi Pharmaceuticals Corporation, the
Company deconsolidated that previously majority-owned subsidiary. As part of the transaction, the
Company deconsolidated $3.7 million of total assets and $4.6 million of total liabilities.
In connection with applicable antidilution adjustments to the price of certain outstanding
warrants in March 2008, the Company recorded a deemed dividend of approximately $757,000 in the six
months ended June 30, 2008. The deemed dividend was recorded as a charge to accumulated deficit and
a corresponding credit to additional paid-in capital.
The accompanying notes are an integral part of these condensed consolidated financial statements.
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CYTRX CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2008
(Unaudited)
(Unaudited)
1. Description of Company and Basis of Presentation
CytRx Corporation (CytRx, the Company, we, us or our) is a clinical-stage
biopharmaceutical company engaged in developing human therapeutic products based primarily upon its
small-molecule molecular chaperone amplification technology. Molecular chaperone proteins occur
normally in human cells and are key components of the bodys defenses against potentially toxic
mis-folded cellular proteins. Since damaged toxic proteins called aggregates are thought to play a
role in many diseases, CytRx believes that amplification of molecular chaperone proteins could have
therapeutic efficacy for a broad range of indications. Currently, CytRx is using its chaperone
amplification technology to develop treatments for neurodegenerative disorders and diabetic
complications. In addition, CytRx has been applying molecular chaperone technology to the
identification of drug candidates for oncology by adapting its proprietary chaperone screening
assay to identify inhibitors (rather than amplifiers) of chaperone activity.
On June 6, 2008, the Company entered into a merger agreement to acquire Innovive
Pharmaceuticals, Inc., or Innovive, a publicly traded biopharmaceutical company with four clinical
stage oncology drug candidates. Under the merger agreement, CytRx will pay initial merger
consideration of $3.0 million in the form of shares of CytRx common stock valued at $0.94 per
share, plus future earnout merger consideration of up to approximately $18.3 million. The merger is
subject to customary closing conditions, including the approval by Innovives stockholders of the
merger agreement. For a more detailed description of the terms of the merger, see Note 11 below.
Through February 2008, the Company owned a majority of the outstanding shares of common stock
of RXi Pharmaceuticals Corporation, or RXi, which was founded in April 2006 by the Company and four
researchers in the field of RNAi, including Dr. Craig Mello, recipient of the 2006 Nobel Prize for
Medicine for his co-discovery of RNAi. RNAi is a naturally occurring mechanism for the regulation
of gene expression that has the potential to selectively inhibit the activity of any human gene.
RXi is focused solely on developing and commercializing therapeutic products based upon RNAi
technologies for the treatment of human diseases, including neurodegenerative diseases, cancer,
type 2 diabetes and obesity. While RXi was majority-owned, the Companys consolidated financial
statements reflected 100% of the assets and liabilities and results of operations of RXi, with the
interests of the minority shareholders of RXi recorded as minority interests. In March 2008, the
Company distributed to its stockholders approximately 36% of RXis outstanding shares, which
reduced CytRxs ownership to less than 50% of RXi. As a result of the reduced ownership, CytRx
began to account for its investment in RXi using the equity method, under which CytRx records only
its pro-rata share of the financial results of RXi against its historical basis investment in RXi.
The investment in RXi is shown as investment in unconsolidated subsidiary on the consolidated
balance sheet and the related earnings are shown as equity in loss of unconsolidated subsidiary
on the consolidated statements of operations. Because only a portion of RXis financial results for
March 2008 were recorded by CytRx under the equity method, the Companys results of operations for
the first six months of 2008 are not directly comparable to results of operations for the same
period in 2007. The future results of operations of the Company also will not be directly
comparable to corresponding periods in prior years during which our financial statements reflected
the consolidation of RXi.
To date, the Company has relied primarily upon sales of its equity securities and upon
proceeds received upon the exercise of options and warrants and, to a much lesser extent, upon
payments from its strategic partners and licensees, to generate funds needed to finance its
business and operations. See Notes 6 and 7 below.
In August 2006, the Company received approximately $24.3 million in proceeds from the
privately-funded ALS Charitable Remainder Trust (ALSCRT) in exchange for the commitment to
continue research and development of arimoclomol and other potential treatments for ALS and a one
percent royalty in the worldwide sales of arimoclomol. Under the arrangement, the Company retains
the rights to any developments funded by the arrangement and the proceeds of the transaction are
non-refundable. The ALSCRT has no obligation to provide any further funding to the Company.
Management has 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 revenue and will recognize service revenue using the proportional performance method of
revenue recognition, meaning that service revenue is recognized on a
dollar-for-dollar basis for each dollar of expense incurred for the research and development
of arimoclomol and other potential ALS treatments.
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The accompanying condensed consolidated financial statements at June 30, 2008 and for the
three-month and six-month periods ended June 30, 2008 and 2007 are unaudited, but include all
adjustments, consisting of normal recurring entries, that management believes to be necessary for a
fair presentation of the periods presented. Prior period figures have
been reclassified, wherever necessary, to conform to current
presentation. Interim results are not necessarily indicative of
results for a full year. Balance sheet amounts as of December 31, 2007 have been derived from the
Companys audited financial statements as of that date.
The consolidated 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 United States of America have been
condensed or omitted pursuant to such rules and regulations. The financial statements should be
read in conjunction with the Companys audited consolidated financial statements in its Form 10-K
for the year ended December 31, 2007. The Companys operating results will fluctuate for the
foreseeable future. Therefore, period-to-period comparisons should not be relied upon as predictive
of the results in future periods.
2. Recent Accounting Pronouncements
In September 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. In February 2008, the FASB issued Staff Position No. FAS 157-1,
which amended SFAS No. 157 to exclude SFAS No. 13, Accounting for Leases, and other accounting
pronouncements that address fair value measurements for purposes of lease classification or
measurement under Statement 13. However, this scope exception does not apply to assets acquired and
liabilities assumed in a business combination. Also in February 2008, the FASB issued Staff
Position No. FAS 157-2, which delayed the effective date of SFAS No. 157 for non-financial assets
and liabilities, except those items recognized at fair value on an annual or more frequently
recurring basis to fiscal years beginning after November 15, 2008 and interim periods within those
fiscal years. The Company adopted SFAS No. 157 with no material impact on the Companys
consolidated financial statements.
In February 2007, the FASB issued SFAS No. 159, Fair Value Option for Financial Assets and
Financial Liabilities (SFAS No. 159). SFAS No. 159 permits entities to choose to measure many
financial assets and financial liabilities at fair value. Unrealized gains and losses on items for
which the fair value option has been elected are reported in earnings. SFAS No. 159 is effective
for fiscal years beginning after November 15, 2007. The Company adopted SFAS No. 159 with no
material impact on the Companys consolidated financial statements.
In June 2007, the FASB ratified the consensus on Emerging Issues Task Force (EITF) Issue No.
06-11, Accounting for Income Tax Benefits of Dividends on Share-Based Payment Awards (EITF
06-11). EITF 06-11 requires companies to recognize the income tax benefit realized from dividends
or dividend equivalents that are charged to retained earnings and paid to employees for non-vested
equity-classified employee share-based payment awards as an increase to additional paid-in capital.
EITF 06-11 is effective for fiscal years beginning after September 15, 2007. The Company adopted
EITF 06-11 with no material impact on the Companys consolidated financial statements.
In June 2007, the FASB ratified the consensus reached on EITF Issue No. 07-3, Accounting for
Nonrefundable Advance Payments for Goods or Services Received for Use in Future Research and
Development Activities (EITF 07-3), which requires that nonrefundable advance payments for goods
or services that will be used or rendered for future research and development activities be
deferred and amortized over the period that the goods are delivered or the related services are
performed, subject to an assessment of recoverability. EITF 07-3 is effective for fiscal years
beginning after December 15, 2007. The Company adopted EITF 07-3 with no material impact on the
Companys consolidated financial statements.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated
Financial Statements (SFAS No. 160) and a revision to SFAS No. 141, Business Combinations (SFAS
No. 141R). SFAS No. 160 modifies the accounting for noncontrolling interest in a subsidiary and
the deconsolidation of a subsidiary. SFAS No. 141R establishes the measurements in a business
combination of the identifiable assets acquired, the liabilities assumed and any noncontrolling
interest in the acquiree. Both of these related statements are effective for fiscal years beginning
after December 15, 2008. The Company has not determined the impact that the adoption of these two
statements will have on the consolidated financial statements.
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In December 2007, the SEC issued Staff Accounting Bulletin 110 (SAB 110), which expresses
the views of the Staff regarding use of a simplified method, as discussed in SAB 107, in
developing an estimate of expected term of plain vanilla share options in accordance with
Statement of Financial Accounting Standards No. 123. SAB 110 will allow, under certain
circumstances, the use of the simplified method beyond December 31, 2007 when an issuer is unable
to rely on the historical exercise data. The Company adopted SAB 110 with no material impact on its
financial statements.
In March 2008, the FASB issued Statement of Financial Accounting Standards No. 161,
Disclosures about Derivative Instruments and Hedging Activities (SFAS No. 161). The new standard
amends Statement of Financial Accounting Standards No. 133, Accounting for Derivative Instruments
and Hedging Activities (SFAS 133), and seeks to enhance disclosure about how and why a company
uses derivatives; how derivative instruments are accounted for under SFAS 133 (and the
interpretations of that standard); and how derivatives affect a companys financial position,
financial performance and cash flows. SFAS 161 will be effective for financial statements issued
for fiscal years and interim periods beginning after November 15, 2008. Early application of the
standard is encouraged, as well as comparative disclosures for earlier periods at initial adoption.
The Company does not believe adoption of this standard will have a material effect on its
financial statements.
In April 2008, the FASB issued Staff Position No. FAS 142-3, Determination of the Useful Life
of Intangible Assets, which amends the factors that should be considered in developing renewal or
extension assumptions used to determine the useful life of a recognized intangible asset under FASB
Statement No. 142, Goodwill and Other Intangible Assets. The Position will be effective for
fiscal years beginning after December 15, 2008 and will only apply prospectively to intangible
assets acquired after the effective date. Early adoption is not permitted. The Company is
currently evaluating the impact this statement will have on our results of operations and financial
position.
In May 2008, the FASB issued Staff Position No. Accounting Principles Board 14-1, Accounting
for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial
Cash Settlement) (FSP No. APB 14-1). FSP No. APB 14-1 requires that the liability and equity
components of convertible debt instruments that may be settled in cash upon conversion (including
partial cash settlement) be separately accounted for in a manner that reflects an issuers
nonconvertible debt borrowing rate. FSP No. APB 14-1 will be effective for us as of January 1,
2009. The Company does not believe adoption of this principle will have a material effect on its
financial statements.
3. Short-term Investments
RXi owned zero coupon U.S Treasury Bills that were purchased at a discount and matured within
twelve months. They were classified as held-to-maturity and under Statement of Financial Accounting
Standards No. 115, Investments in Debt Securities, were measured at amortized cost, since RXi had
the intent and ability to hold these securities to maturity. The interest income was amortized at
the effective interest rate.
4. Basic and Diluted Loss Per Common Share
Basic and diluted loss per common share are computed based on the weighted-average number of
common shares outstanding. Common share equivalents (which consist of options and warrants) are
excluded from the computation of diluted loss per share, since the effect would be antidilutive.
Common share equivalents which could potentially dilute basic earnings per share in the future, and
that were excluded from the computation of diluted loss per share, totaled approximately 15.8
million and 20.4 million shares at June 30, 2008 and 2007, respectively.
In connection with applicable antidilution adjustments to the terms of certain outstanding
warrants to purchase common stock in March 2008, the Company recorded a deemed dividend of
approximately $757,000. The deemed dividend is reflected as an adjustment to net loss for the first
quarter of 2008, 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.
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5. Stock Based Compensation
CytRx Corporation
The Company has a stock option plan, the 2000 Stock Option Incentive Plan, under which, as of
June 30, 2008, an aggregate of 10,000,000 shares of common stock were reserved for issuance,
including approximately 6,674,756 shares subject to outstanding stock
options and approximately 1,442,032 shares available for future grant. The Company also has
two other plans, the 1994 Stock Option Plan and the 1998 Long Term Incentive Plan, under which
9,167 shares and 100,041 shares, respectively, are subject to outstanding stock options. The terms
of these plans provide that no options may be issued after ten years, so no options are available
for future grant under either of the plans. Options granted under the Companys option 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 expire, unless previously exercised, not later than ten
years from the grant date.
The Companys stock-based employee compensation plans are described in Note 12 to its
financial statements contained in its Annual Report on Form 10-K filed for the year ended December
31, 2007.
The Company has adopted the provisions of SFAS No. 123(R), Share-Based Payment (SFAS
123(R)), which requires the measurement and recognition of compensation expense for all
stock-based awards made to employees and non-employees.
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), Emerging Issues Task Force Issue No. 96-18 (EITF 96-18),
Accounting for Equity Instruments that are Issued to other than Employees for Acquiring, or in
Conjunction with Selling Goods or Services and EITF 00-18, Accounting Recognition for Certain
Transactions involving Equity Instruments Granted to Other Than Employees, as amended.
Non-employee option grants that do not vest immediately upon grant are recorded as an expense
over the vesting period. At the end of each financial reporting period prior to performance, the
value of these options, as calculated using the Black-Scholes option-pricing model, is determined,
and compensation expense recognized or recovered during the period is adjusted accordingly. Since
the fair market value of options granted to non-employees is subject to change in the future, the
amount of the future compensation expense is subject to adjustment until the common stock options
are fully vested.
The following table sets forth the total stock-based compensation expense (recovery) resulting
from stock options included in the Companys unaudited interim consolidated statements of
operations:
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2008 | 2007 | 2008 | 2007 | |||||||||||||
Research and development employee |
$ | 182,000 | $ | 144,000 | $ | 353,000 | $ | 180,000 | ||||||||
General and administrative employee |
316,000 | 270,000 | 607,000 | 382,000 | ||||||||||||
Total employee stock-based compensation |
$ | 498,000 | $ | 414,000 | $ | 960,000 | $ | 562,000 | ||||||||
Research and development non-employee (recovery) |
$ | | $ | (393,000 | ) | $ | (422,000 | ) | $ | 303,000 | ||||||
General and administrative non-employee |
| | | | ||||||||||||
Total non-employee stock-based compensation |
$ | | $ | (393,000 | ) | $ | (422,000 | ) | $ | 303,000 | ||||||
During the first six months of 2008, the Company issued stock options to purchase 815,000
shares of its common stock. The fair value of the stock options granted in the six-month period
listed in the table below was estimated using the Black-Scholes option-pricing model, based on the
following assumptions:
Six Months Ended June 30, | ||||||||
2008 | 2007 | |||||||
Risk-free interest rate |
2.72%-3.84 | % | 4.43%-4.78 | % | ||||
Expected volatility |
93.8%-96.7 | % | 108.7 | % | ||||
Expected lives (years) |
6 | 6 | ||||||
Expected dividend yield |
0.00 | % | 0.00 | % |
The Companys computation of expected volatility is based on the historical daily volatility
of its publicly traded stock. For option grants issued during the six-month periods ended June 30,
2008 and 2007, the Company used a calculated volatility for each grant. The Companys computation
of expected life were estimated using the simplified method provided for under Staff Accounting
Bulletin 107, Share-Based Payment (SAB 107), which averages the contractual term of the Companys
options of ten years with the average vesting term of three years for an average of six years. The
dividend yield assumption of zero is based upon the fact the Company has never paid cash dividends
and presently has no intention of paying cash dividends. The risk-free interest rate used for each
grant is equal to the U.S. Treasury rates in effect at the time of the grant for instruments with a
similar expected life. Based on historical experience, for the six-month periods ended June 30,
2008 and 2007, the Company has estimated an annualized forfeiture rate of 10% and 5%, respectively,
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for options granted to its employees, 1% for each period for options granted to senior
management and 0% for each period for options granted to directors. Compensation costs will be
adjusted for future changes in estimated forfeitures. 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. No amounts relating to employee stock-based
compensation have been capitalized.
At June 30, 2008, there remained approximately $3.5 million of unrecognized compensation
expense related to unvested stock options granted to current and former employees, directors and
consultants, to be recognized as expense over a weighted-average period of 1.41 years. Presented
below is the Companys stock option activity:
Six Months Ended June 30, 2008 | ||||||||||||||||
Number of Options | Number of Options | Total Number | Weighted Average | |||||||||||||
(Employees) | (Non-Employees) | of Options | Exercise Price | |||||||||||||
Outstanding at January 1, 2008 |
4,594,000 | 1,397,000 | 5,991,000 | $ | 2.29 | |||||||||||
Granted |
901,000 | | 901,000 | $ | 1.26 | |||||||||||
Exercised |
(55,000 | ) | | (55,000 | ) | $ | 0.92 | |||||||||
Forfeited |
(162,000 | ) | | (162,000 | ) | $ | 2.92 | |||||||||
Outstanding at June 30, 2008 |
5,278,000 | 1,397,000 | 6,675,000 | $ | 2.14 | |||||||||||
Options exercisable at June 30, 2008 |
3,145,000 | 1,147,000 | 4,292,000 | $ | 1.93 | |||||||||||
A summary of the activity for non-vested stock options as of June 30, 2008 is presented below:
Weighted Average | ||||||||||||||||
Number of Options | Number of Options | Total Number of | Grant Date Fair | |||||||||||||
(Employees) | (Non-Employees) | Options | Value per Share | |||||||||||||
Non-vested at January 1, 2008 |
1,734,000 | 250,000 | 1,984,000 | $ | 2.91 | |||||||||||
Granted |
901,000 | | 901,000 | $ | 0.99 | |||||||||||
Forfeited |
(162,000 | ) | | (162,000 | ) | $ | 2.46 | |||||||||
Vested |
(340,000 | ) | | (340,000 | ) | $ | 2.24 | |||||||||
Non-vested at June 30, 2008 |
2,133,000 | 250,000 | 2,383,000 | $ | 2.31 | |||||||||||
The following table summarizes significant ranges of outstanding stock options under the
Companys plans at June 30, 2008:
Weighted Average | Weighted | Weighted | Weighted | |||||||||||||||||||||
Remaining | Average | Number of | Average | Average | ||||||||||||||||||||
Range of | Number of | Contractual Life | Exercise | Options | Contractual | Exercise | ||||||||||||||||||
Exercise Prices | Options | (years) | Price | Exercisable | Life | Price | ||||||||||||||||||
$0.65 - 1.00 |
800,000 | 6.67 | $ | 0.80 | 735,000 | 6.67 | $ | 0.80 | ||||||||||||||||
$1.01 - 2.00 |
3,137,000 | 7.48 | $ | 1.41 | 1,946,000 | 7.48 | $ | 1.51 | ||||||||||||||||
$2.01 - 3.00 |
1,130,000 | 5.07 | $ | 2.46 | 1,112,000 | 5.07 | $ | 2.46 | ||||||||||||||||
$3.01 - 4.00 |
623,000 | 9.22 | $ | 3.42 | 163,000 | 9.22 | $ | 3.35 | ||||||||||||||||
$4.01 - 4.65 |
985,000 | 8.85 | $ | 4.42 | 336,000 | 8.85 | $ | 4.41 | ||||||||||||||||
6,675,000 | 7.34 | $ | 2.14 | 4,292,000 | 7.34 | $ | 1.93 | |||||||||||||||||
The aggregate intrinsic value of outstanding options as of June 30, 2008 was approximately $0.
The aggregate intrinsic value was calculated based on the positive difference between the closing
fair market value of the Companys common stock on June 30, 2008 of $0.65 per share and the
exercise price of the underlying options. The intrinsic value of options exercised was $28,000 for
the six-month period ended June 30, 2008, and the intrinsic value of options that vested was
approximately $0 for the same period.
RXi Pharmaceuticals
RXi has its own stock option plan, the RXi Pharmaceuticals Corporation 2007 Incentive Plan.
RXi accounted for stock option expense in the same manner as CytRx as described above.
As discussed in Note 9, the Company started accounting for its investment in RXi under the
equity method in March 2008, and accordingly, the following table sets forth the total stock-based
compensation expense for January and February 2008 resulting from RXi stock options that is
included in the Companys unaudited condensed consolidated statements of operations:
Six Months Ended June 30, | ||||||||
2008 | 2007 | |||||||
Research and development employee |
$ | 28,000 | $ | 32,000 | ||||
General and administrative employee |
369,000 | 297,000 | ||||||
Total employee stock-based compensation |
$ | 397,000 | $ | 329,000 | ||||
Research and development non-employee |
$ | 121,000 | $ | 1,012,000 | ||||
General and administrative non-employee |
| | ||||||
Total non-employee stock-based compensation |
$ | 121,000 | $ | 1,012,000 | ||||
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6. Liquidity and Capital Resources
At June 30, 2008, the Company had cash, cash equivalents and short-term investments of
approximately $36.4 million. Management believes that its current resources, without inclusion of
the possible sale of shares of RXi common stock (see note 9), will be sufficient to support
the Companys currently planned level of operations into the second half of 2009. This estimate is
based, in part, upon our currently projected expenditures for the remainder of 2008 and the first
six months of 2009 of approximately $26.4 million, including approximately $1.8 million of direct
expenditures for its planned clinical program for arimoclomol for ALS and related studies,
approximately $0.3 million of direct expenditures for its planned clinical program for arimoclomol
for stroke recovery and related studies, approximately $8.0 million of direct expenditures for its
planned Phase II clinical trial of iroxanadine for diabetic ulcers and related studies,
approximately $8.1 million for the operations of its research laboratory in San Diego, California,
and approximately $8.2 million for other general and administrative expenses. The Companys
projected expenditures are based on our recently announced plan to conduct additional animal
toxicology studies prior to the resumption of its Phase II clinical program for arimoclomol for ALS
that currently is on clinical hold by the FDA and prior to any initiation of its Phase II clinical
trial for arimoclomol for stroke recovery. Those animal toxicology studies are expected to take
approximately one year. These projected expenditures are based upon numerous other assumptions and
subject to many uncertainties, and the Companys actual expenditures may be significantly different
from these projections. These projected expenditures also do not consider the effects of the
pending acquisition of Innovive on the Companys operations and financial condition. Assuming that
the acquisition is completed, the Company will need additional funds to advance any of Innovives
product candidates. The Company will be required to obtain additional funding in order to execute
its long-term business plans, although it does not currently have commitments from any third
parties to provide it with capital. The Company cannot assure that additional funding will be
available on favorable terms, or at all. If the Company fails to obtain additional funding when
needed, it may not be able to execute its business plans and its business may suffer, which would
have a material adverse effect on its financial position, results of operations and cash flows.
7. Equity Transactions
On March 11, 2008, the Company paid a dividend to its stockholders of approximately 36% of the
outstanding shares of RXi common stock. In connection with that dividend, the Company adjusted the
price of warrants to purchase approximately 10.6 million shares that had been issued in prior
equity financings in October 2004, January 2005 and March 2006. The adjustments were made as a
result of anti-dilution provisions in those warrants that were triggered by the Companys
distribution of a portion of its assets to its stockholders. 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 $757,000 charge to accumulated deficit
and a corresponding credit to additional paid-in capital.
On April 19, 2007, the Company completed a $37.0 million private equity financing in which it
issued approximately 8.6 million shares of its common stock at a price of $4.30 per share. Net of
investment banking commissions, legal, accounting and other expenses related to the transaction,
the Company received proceeds of approximately $34.2 million. On April 30, 2007, the Company
contributed $15.0 million, net of reimbursed expenses estimated at $2.0 million paid by RXi to the
Company, in exchange for equity in RXi, in order to satisfy the initial funding requirements under
its agreements with the University of Massachusetts Medical School (UMMS). In September 2007, the
actual reimbursed expenses paid by RXi to the Company were finally determined to be approximately
$3.0 million, and on September 25, 2007, RXi issued to CytRx additional equity as reimbursement of
the excess expenses. Following those transactions, CytRx owned approximately 85% of the outstanding
capital stock of RXi, of which approximately 36% was paid as a dividend to CytRx stockholders on
March 11, 2008.
In connection with the April 2007 private equity financing, the Company adjusted the price and
number of underlying shares of warrants to purchase approximately 1.4 million shares that had been
issued in prior equity financings in May and September 2003. The adjustments were was made as a
result of anti-dilution provisions in those warrants that were triggered by the Companys issuance
of common stock in the April 2007 financing at a price below the closing market price on the date
of the transaction. For the reasons described above, the Company accounted for the anti-dilution
adjustments as deemed dividends. Because the fair value of the
outstanding warrants decreased as a result of the anti-dilution adjustment, no deemed dividend
was recorded, and thus the Company did not record a charge to retained earnings or a corresponding
credit to additional paid-in capital.
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In connection with the April 2007 private equity financing, the Company entered into a
registration rights agreement with the purchasers of its common stock and warrants. That agreement
provided, among other things, for cash penalties, up to a maximum of 16% (approximately $5.9
million) of the purchase price paid for the securities in the event that the Company failed to
initially register or maintain the effective registration of the securities until the sooner of two
years or the date on which the securities could be sold pursuant to Rule 144 of the Securities Act
of 1933, as amended. The Company evaluated the penalty provisions of the April 2007 registration
rights agreement in light of FASB Staff Position No. EITF 00-19-2, Accounting for Registration
Payment Arrangements, which specifies that the contingent obligation to make future payments or
otherwise transfer consideration under a registration payment arrangement should be separately
recognized and measured in accordance with FASB Statement No. 5, Accounting for Contingencies,
pursuant to which a contingent obligation must be accrued only if it is reasonably estimable and
probable. In managements estimation, the contingent payments related to the registration payment
arrangement are not probable to occur, and thus no amount was accrued.
During the three-month and six-month periods ended June 30, 2008, the Company issued 1.0
million shares of its common stock, and received $0.9 million, upon the exercise of stock options
and warrants. During the three-month and six-month periods ended June 30, 2007, the Company issued
2.6 million and 9.5 million shares, respectively, of its common stock, and received $4.8 million
and $15.9 million, respectively, upon the exercise of stock options and warrants.
8. Minority Interest
Through February 2008, the Company owned approximately 85% of the outstanding shares of common
stock of RXi. While RXi was majority-owned, the Companys consolidated financial statements
reflected 100% of the assets and liabilities and results of operations of RXi, with the interests
of the minority shareholders of RXi recorded as minority interests. In March 2008, the Company
distributed to its stockholders approximately 36% of RXis outstanding shares, which reduced
CytRxs ownership to less than 50% of RXi. As a result, CytRx began to account for its investment
in RXi using the equity method, under which CytRx records only its pro-rata share of the financial
results of RXi against its historical basis investment in RXi. Because only a portion of RXis
financial results for March 2008 were recorded by CytRx under the equity method, the Companys
results of operations for the first six months of 2008 are not directly comparable to results of
operations for the same period in 2007. The future results of operations of the Company also will
not be directly comparable to corresponding periods in prior years during which our financial
statements reflected the consolidation of RXi.
The Company offset $88,000 of minority interest in losses of RXi against its net loss for the
months of January and February 2008, and $176,000 and $178,000 of minority interest in losses of
RXi against its net loss for the three-month and six-month periods ended June 30, 2007,
respectively.
9. Equity Investment in RXi
In the first quarter of 2008, the Company distributed to its stockholders approximately 36% of
RXis outstanding shares, which reduced CytRxs ownership to less than 50% of RXi. Management
determined that the distribution of the RXi common stock to stockholders of CytRx represented a
partial spin-off of RXi and accounted for the distribution of the RXi common shares at cost. As a
result of its reduced ownership in RXi, CytRx began to account for its investment in RXi using the
equity method, under which CytRx records only its pro-rata share of the financial results of RXi
against its historical basis investment in RXi. The following table presents summarized financial
information for RXi for the three and six-month periods ended June 30, 2008:
Three-Month | Six-Month | |||||||
Period Ended | Period Ended | |||||||
Income Statement Data (unaudited, in thousands) | June 30, 2008 | June 30, 2008 | ||||||
Sales |
$ | | $ | | ||||
Gross profit |
| | ||||||
Loss from continuing operations |
(4,346 | ) | (7,059 | ) | ||||
Loss |
(4,318 | ) | (6,964 | ) |
Balance Sheet Data (unaudited, in thousands) | June 30, 2008 | |||
Current assets |
$ | 15,433 | ||
Noncurrent assets |
409 | |||
Current liabilities |
1,522 | |||
Stockholders equity |
14,307 |
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On June 30, 2008, RXi issued and sold 1,079,299 common shares to certain investors, which
effectively reduced CytRxs ownership to approximately 45%.
At June 30, 2008, the fair value of CytRxs ownership of 6,268,881 shares of RXis common
stock was $50,151,000 based on the closing price of RXis common stock on that date.
10. Income Taxes
On March 11, 2008, we distributed to our stockholders approximately 4.5 million shares of RXi
common stock. We will recognize approximately a $32.9 million gain for income tax purposes on the
distribution of shares of RXi common stock, which is the amount equal to the excess of the fair
market value of the stock distributed over our basis. The gain will be included in determining
whether we have current year earnings and profits subject to taxation. Based upon our anticipated
loss from operations for 2008 and currently available loss carryforwards, we expect to pay no
regular income taxes in connection with the distribution; however, we have recorded a tax provision
of $342,000 related to the estimated Alternative Minimum Tax resulting from this gain.
11. Pending Acquisition
On June 6, 2008, the Company entered into an agreement and plan of merger with Innovive
Pharmaceuticals, Inc., or Innovive, CytRx Merger Subsidiary, Inc., a wholly owned subsidiary of
CytRx, and Steven Kelly, Innovives President and Chief Executive Officer, as representative of
Innovive stockholders. Pursuant to the terms of the merger agreement, the Company will acquire
Innovive by means of the merger of Merger Subsidiary with and into Innovive, and as a result
Innovive will continue as the surviving corporation and will become a wholly owned subsidiary of
CytRx.
Under the merger agreement, CytRx will pay initial merger consideration of $3.0 million, plus
future earnout merger consideration of up to approximately $18.3 million. At the effective time of
the merger, all of the outstanding shares of Innovive common stock (other than shares owned by
Innovive, CytRx and Merger Subsidiary and by any stockholders who properly exercise their rights as
dissenting stockholders under Delaware law), will be cancelled and converted into the right to
receive from CytRx their allocable share of the merger consideration based on the fully diluted
shares of Innovive at that time. The initial merger consideration will be payable in the form of
shares of CytRx common stock valued at $0.94 per share, which equaled the average daily
volume-weighted closing price of CytRx common stock as reported on The Nasdaq Capital Market over
the ten trading days prior to June 6, 2008, the date the merger agreement was signed. The earnout
merger consideration is subject to the future achievement of specified net sales under the existing
Innovive license agreements. The earnout merger consideration, if any, will be payable in shares of
CytRx common stock, subject to specified conditions, or, at the Companys election, in cash, or by
a combination of shares of CytRx common stock and cash. CytRx common stock will be valued for
purposes of any earnout merger consideration based upon the trading price of CytRx common stock at
the time the earnout merger consideration is paid.
Under accounting principles generally accepted in the United States and the regulations of the
Securities and Exchange Commission, since Innovive is a development stage company, it is not
considered a business. Accordingly, the merger will be accounted for by CytRx in accordance with
Statement of Financial Standard No. 142, Goodwill and Other Intangible Assets, for transactions
other than a business combination. Management of CytRx has further determined it is not required
to include in this Form 10-Q proforma financial statements giving effect to the merger.
The initial merger consideration, together with direct costs incurred to effect the merger,
will be allocated to the individual assets acquired, including identifiable intangible assets and
liabilities assumed based on the relative fair value. No goodwill will be recorded. Consolidated
financial statements of CytRx issued after the merger will reflect these fair values and will not
be restated retroactively to reflect the historical financial position or results of operations of
Innovive. It is anticipated that CytRx will record a one-time expense for in-process research and
development it acquires.
Completion of the merger is subject to customary closing conditions, including the absence of
certain legal impediments to the merger, the effectiveness of certain filings with the SEC,
approval by Innovives stockholders of the merger agreement and that the Innovive shares held by
any dissenting stockholders not exceed 5% of Innovives outstanding shares. The Company expects to
complete the merger during the third calendar quarter of 2008, with the exact timing dependent upon
a number of factors.
The merger agreement contains specified termination rights for both Innovive and the Company.
Among other things and subject to certain conditions, (i) Innovive may terminate the merger
agreement to accept a superior proposal (as defined in the merger agreement), and (ii) the
Company may terminate the merger agreement if the board of directors of Innovive changes or
withdraws, or fails to reaffirm, its recommendation to Innovives stockholders that they approve
the merger agreement. In general, either Innovive or the Company may terminate the merger agreement
if the merger has not occurred by September 30, 2008. The merger agreement further provides that,
upon termination of the merger agreement under certain circumstances, Innovive may be obligated to
pay us a termination fee of $1.5 million.
Also on June 6, 2008, CytRx entered into a loan and security agreement with Innovive pursuant
to which the Company agreed to advance funds to Innovive to be used to pay current accounts payable
and accrued expenses of Innovive. As of August 6, 2008, we had advanced to Innovive under the loan
and security agreement a total of approximately $2,690,000, and Innovive may request additional
advances of up to approximately $2,810,000 pending the merger. Additional advances requested by
Innovive are at the Companys discretion. All advances under the loan agreement are secured by a
lien on all or substantially all of Innovives assets, bear interest at the rate of 12.5% per annum, and generally will be due and payable, in full, together with accrued
interest, on the date of termination of the merger agreement or
September 30, 2008. In June 2008, we set a reserve of $690,000
against the advance based upon the estimated recoverable value of the
underlying security.
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In consideration for making the initial advance and entering into the loan agreement, Innovive
granted CytRx under the loan agreement a one-year option, exercisable in certain circumstances if
the merger agreement is terminated by Innovive, to purchase up to 2,000,000 shares of common stock
of Innovive at an exercise price of $0.01 per share.
As of June 30, 2008, CytRx had advanced to Innovive under the loan and security agreement a
total of approximately $2.3 million.
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 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, as well as those made
in our other filings with the SEC.
All statements in this Quarterly Report, including statements in this section, other than
statements of historical fact are forward-looking statements for purposes of these provisions,
including statements of our current views with respect to the recent developments regarding our
majority-owned subsidiary, RXi Pharmaceuticals Corporation, our business strategy, business plan
and research and development activities, our future financial results, and other future events.
These statements include forward-looking statements both with respect to us, specifically, and the
biotechnology industry, in general. In some cases, forward-looking statements can be identified by
the use of terminology such as may, will, expects, plans, anticipates, estimates,
potential or could or the negative thereof or other comparable terminology. Although we believe
that the expectations reflected in the forward-looking statements contained herein are reasonable,
there can be no assurance that such expectations or any of the forward-looking statements will
prove to be correct, and actual results could differ materially from those projected or assumed in
the forward-looking statements.
All forward-looking statements involve inherent risks and uncertainties, and there are or will
be important factors that could cause actual results to differ materially from those indicated in
these statements. We believe that these factors include, but are not limited to, those factors set
forth in this Quarterly Report under the captions Risk Factors and Managements Discussion and
Analysis of Financial Condition and Results of Operations, all of which you should review
carefully. If one or more of these or other risks or uncertainties materialize, or if our
underlying assumptions prove to be incorrect, actual results may vary materially from what we
anticipate. Please consider our forward-looking statements in light of those risks as you read this
Quarterly Report. We undertake no obligation to publicly update or review any forward-looking
statement, whether as a result of new information, future developments or otherwise.
Overview
CytRx Corporation (CytRx, the Company, we, us or our) is a clinical-stage
biopharmaceutical company engaged in developing human therapeutic products based primarily upon its
small-molecule molecular chaperone amplification technology. Molecular chaperone proteins occur
normally in human cells and are key components of the bodys defenses against potentially toxic
mis-folded cellular proteins. Since damaged toxic proteins called aggregates are thought to play a
role in many diseases, CytRx believes that amplification of molecular chaperone proteins could have
therapeutic efficacy for a broad range of indications. Currently, CytRx is using its chaperone
amplification technology to develop treatments for neurodegenerative disorders and diabetic
complications. In addition, CytRx has been applying molecular chaperone technology to the
identification of drug candidates for oncology by adapting its proprietary chaperone screening
assay to identify inhibitors (rather than amplifiers) of chaperone activity.
On June 6, 2008, we entered into a merger agreement to acquire Innovive Pharmaceuticals, Inc.,
or Innovive, a publicly traded biopharmaceutical company with four clinical stage oncology drug
candidates. Under the merger agreement, we will pay initial merger consideration totaling $3.0
million in the form of shares of our common stock valued at $0.94 per share, plus future earnout
merger consideration of up to approximately $18.3 million. The merger is subject to customary
closing conditions, including the approval by Innovives stockholders of the merger agreement.
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Table of Contents
Through February 2008, we owned a majority of the outstanding shares of common stock of RXi
Pharmaceuticals Corporation, or RXi, which was founded in April 2006 by the Company and four
researchers in the field of RNAi, including Dr. Craig Mello, recipient of the 2006 Nobel Prize for
Medicine for his co-discovery of RNAi. RNAi is a naturally occurring mechanism for the regulation
of gene expression that has the potential to selectively inhibit the activity of any human gene.
RXi is focused solely on developing and commercializing therapeutic products based upon RNAi
technologies for the treatment of human diseases, including neurodegenerative diseases, cancer,
type 2 diabetes and obesity. While RXi was majority-owned, our consolidated financial statements
reflected 100% of the assets and liabilities and results of operations of RXi, with the interests
of the minority shareholders of RXi recorded as minority interests. In March 2008, we distributed
to our stockholders approximately 36% of RXis outstanding shares, which reduced our ownership to
less than 50% of RXi. As a result of the reduced ownership, we began to account for its investment
in RXi using the equity method, under which we record only our pro-rata share of the financial
results of RXi against our historical basis investment in RXi. The investment in RXi is shown as
investment in unconsolidated subsidiary on the consolidated balance sheet and the related
earnings are shown as equity in loss of unconsolidated subsidiary on the consolidated statements
of operations. Because only a portion of RXis financial results for March 2008 were recorded by us
under the equity method, our results of operations for the first six months of 2008 are not
directly comparable to results of operations for the same period in 2007. The future results of
operations of the Company also will not be directly comparable to corresponding periods in prior
years during which our financial statements reflected the consolidation of RXi.
We have relied primarily upon proceeds from sales of our equity securities and the exercise of
options and warrants, and to a much lesser extent upon payments from our strategic partners and
licensees, to generate funds needed to finance our business and operations. At June 30, 2008, we
had cash, cash equivalents and short-term investments of approximately $36.4 million. We believe
that our current resources, without inclusion of the possible liquidation of shares of RXi common
stock (see note 9), will be sufficient to support our currently planned level of operations into
the second half of 2009. This estimate is based, in part, upon our currently projected
expenditures for the remainder of 2008 and the first six months of 2009 of approximately $26.4
million, including approximately $1.8 million of direct expenditures for our planned clinical
program for arimoclomol for ALS and related studies, approximately $0.3 million of direct
expenditures for our planned clinical program for arimoclomol for stroke recovery and related
studies, approximately $8.0 million of direct expenditures for our planned Phase II clinical trial
of iroxanadine for diabetic ulcers and related studies, approximately $8.1 million for the
operations of our research laboratory in San Diego, California, and approximately $8.2 million for
other general and administrative expenses. Our projected expenditures are based on our recently
announced plan to conduct additional animal toxicology studies prior to the resumption of our Phase
II clinical program for arimoclomol for ALS that currently is on clinical hold by the FDA and prior
to any initiation of our Phase II clinical trial for arimoclomol for stroke recovery. Those animal
toxicology studies are expected to take approximately one year. These projected expenditures are
based upon numerous other assumptions and subject to many uncertainties, and our actual
expenditures may be significantly different from these projections. These projected expenditures
also do not consider the effects of the pending acquisition of Innovive on our operations and
financial condition. Assuming that the acquisition is completed, we will need additional funds to
advance any of Innovives product candidates.
We will be required to obtain additional funding in order to execute our long-term business
plans. We do not have commitments from any third parties to provide us with capital and we cannot
assure that additional funding will be available on favorable terms, or at all. If we fail to
obtain additional funding when needed, we may not be able to execute our business plans and our
business may suffer, which would have a material adverse effect on our financial position, results
of operations and cash flows.
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 of America. The preparation of these
consolidated financial statements requires management to make estimates and judgments that affect
the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of
contingent assets and liabilities. On an ongoing basis, management evaluates its estimates,
including those related to revenue recognition, impairment of long-lived assets, including finite
lived intangible assets, research and development expenses and clinical trial expenses and
stock-based compensation expense.
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, 2007. We believe
the following critical accounting policies affect our more significant judgments and estimates used
in the preparation of our consolidated financial statements:
15
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Revenue Recognition
Revenue
consists of license fees from strategic alliances with pharmaceutical companies as
well as service and grant revenues. Service revenue consists of contract research and laboratory
consulting. Grant revenues consist of government and private grants.
Monies received for license fees are deferred and recognized ratably over the performance
period in accordance with Staff Accounting Bulletin (SAB) No. 104, Revenue Recognition. Milestone
payments will be recognized upon achievement of the milestone as long as the milestone is deemed
substantive and we have no other performance obligations related to the milestone and
collectability is reasonably assured, which is generally upon receipt, or recognized upon
termination of the agreement and all related obligations. Deferred revenue represents amounts
received prior to revenue recognition.
Revenues from contract research, government grants, and consulting fees are recognized over
the respective contract periods as the services are performed, provided there is persuasive
evidence or an arrangement, the fee is fixed or determinable and collection of the related
receivable is reasonably assured. Once all conditions of the grant are met and no contingencies
remain outstanding, the revenue is recognized as grant fee revenue and an earned but unbilled
revenue receivable is recorded.
In August 2006, we received approximately $24.3 million in proceeds from the privately-funded
ALS Charitable Remainder Trust (ALSCRT) in exchange for the commitment to continue research and
development of arimoclomol and other potential treatments for ALS and a one percent royalty in the
worldwide sales of arimoclomol. Under the arrangement, we retain the rights to any products or
intellectual property funded by the arrangement and the proceeds of the transaction are
non-refundable. The ALSCRT has no obligation to provide any further funding to us. We have
concluded that due to the research and development components of the transaction that it is
properly accounted for under Statement of Financial Accounting Standards No. 68, Research and
Development Arrangements. Accordingly, we have recorded the value received under the arrangement as
deferred service revenue and will recognize service revenue using the proportional performance
method of revenue recognition, meaning that service revenue is recognized on a dollar-for-dollar
basis for each dollar of expense incurred for the research and development of arimoclomol and other
potential ALS treatments. We believe that this method best approximates the efforts expended
related to the services provided. We adjust our estimates of expense incurred for this research and
development on a quarterly basis. For the three-month and six-month periods ended June 30, 2008 and
2007, we recognized approximately $1.7 million, $3.9 million, $2.4 million and $3.8 million,
respectively, of service revenue related to this transaction. Any significant change in ALS related
research and development expense in any particular quarterly or annual period will result in a
change in the recognition of revenue for that period and consequently affect the comparability or
revenue from period to period.
The amount of deferred revenue, current portion is the amount of deferred revenue that is
expected to be recognized in the next twelve months and is subject to fluctuation based upon
managements estimates. Managements estimates include an evaluation of what pre-clinical and
clinical trials are necessary, the timing of when trials will be performed and the estimated
clinical trial expenses. These estimates are subject to changes and could have a significant effect
on the amount and timing of when the deferred revenues are recognized.
Research and Development Expenses
Research and development expenses consist of costs incurred for direct and overhead-related
research expenses and are expensed as incurred. Costs to acquire technologies, including licenses,
that are utilized in research and development and that have no alternative future use are expensed
when incurred. Technology developed for use in its products is expensed as incurred until
technological feasibility has been established.
Clinical Trial Expenses
Clinical trial expenses, which are included in research and development expenses, include
obligations resulting from our contracts with various clinical research organizations in connection
with conducting clinical trials for our product candidates. We recognize expenses for these
activities based on a variety of factors, including actual and estimated labor hours, clinical site
initiation activities, patient enrollment rates, estimates of external costs and other
activity-based factors. We believe that this method best approximates the efforts expended on a
clinical trial with the expenses we record. We adjust our rate of clinical expense recognition if
actual results differ from our estimates. If our estimates are incorrect, clinical trial expenses
recorded in any particular period could vary.
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Stock-Based Compensation
Our share-based employee compensation plans are described in Note 5 to our interim financial
statements. SFAS 123(R), Share-Based Payment, requires the recognition of compensation expense
associated with stock option grants and other equity instruments to employees in the financial
statements. We adopted SFAS 123(R) using the modified-prospective method and use the Black-Scholes
valuation model for valuing share-based payments. We 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), Emerging Issues Task Force Issue No. 96-18 (EITF
96-18), Accounting for Equity Instruments that are Issued to other than Employees for Acquiring,
or in Conjunction with Selling Goods or Services and EITF 00-18, Accounting Recognition for Certain
Transactions involving Equity Instruments Granted to Other Than Employees, as amended.
Non-employee share-based compensation charges generally are amortized over the vesting period
on a straight-line basis. In certain circumstances, option grants to non-employees are immediately
vested and have no future performance requirements by the non-employee and the total share-based
compensation charge is recorded in the period of the measurement date.
The fair value of each CytRx and RXi common stock option grant is estimated using the
Black-Scholes option-pricing model, which uses certain assumptions related to risk-free interest
rates, expected volatility, expected life of the common stock options and future dividends.
Compensation expense is recorded based upon the value derived from the Black-Scholes option-pricing
model, based on an expected forfeiture rate that is adjusted for actual experience. If our
Black-Scholes option-pricing model assumptions or our actual or estimated forfeiture rate are
different in the future, that could materially affect compensation expense recorded in future
periods.
Impairment of Long-Lived Assets
We review long-lived assets, including finite lived intangible assets, for impairment on an
annual basis, as of December 31, or on an interim basis if an event occurs that might reduce the
fair value of such assets below their carrying values. An impairment loss would be recognized based
on the difference between the carrying value of the asset and its estimated fair value, which would
be determined based on either discounted future cash flows or other appropriate fair value methods.
If our estimates used in the determination of either discounted future cash flows or other
appropriate fair value methods are not accurate as compared to actual future results we may be
required to record an impairment charge.
Earnings Per Share
Basic and diluted loss per common share are computed based on the weighted-average number of
common shares outstanding. Common share equivalents (which consist of options and warrants) are
excluded from the computation of diluted loss per share, since the effect would be anti-dilutive.
Common share equivalents that could potentially dilute basic earnings per share in the future, but
were excluded from the computation of diluted loss per share, totaled approximately 15.8 million
shares and 20.4 million shares at June 30, 2008 and 2007, respectively. In connection with the
dividend of 36% of the outstanding shares of RXi paid to our stockholders on March 11, 2008, we
recorded a deemed dividend of $757,000. The deemed dividend was reflected as an adjustment to net
loss for the first quarter of 2008, to arrive at net loss applicable to common stockholders on the
consolidated statement of operations and for purposes of calculating basic and diluted loss per
shares.
Liquidity and Capital Resources
We have relied primarily upon proceeds from sales of our equity securities and the exercise of
options and warrants, and to a much lesser extent upon payments from our strategic partners and
licensees, to generate funds needed to finance our business and operations. At June 30, 2008, we
had cash, cash equivalents and short-term investments of approximately $36.4 million. We believe
that our current resources, without inclusion of the possible sale of shares of RXi common
stock (see note 9), will be sufficient to support our currently planned level of operations into
the second half of 2009. This estimate is based, in part, upon our currently projected
expenditures for the remainder of 2008 and the first six months of 2009 of approximately $26.4
million, including approximately $1.8 million of direct expenditures for our planned clinical
program for arimoclomol for ALS and related studies, approximately $0.3 million of direct
expenditures for our planned clinical program for arimoclomol for stroke recovery and related
studies, approximately $8.0 million of direct expenditures for our planned Phase II clinical trial
of iroxanadine for diabetic ulcers and related studies, approximately $8.1 million for the
operations of our research laboratory in San Diego, California, and approximately $8.2 million for
other general and administrative expenses. Our projected expenditures are based on our recently
announced plan to conduct additional animal toxicology studies prior to the resumption of our Phase
II clinical program for arimoclomol for ALS that currently is on clinical hold by the FDA and prior
to any initiation of our Phase II clinical trial for arimoclomol for stroke recovery. Those animal
toxicology studies are expected to take approximately one year. These projected expenditures are
based upon numerous other assumptions and subject to many uncertainties, and our actual expenditures may be significantly different from these
projections. These projected expenditures also do not consider the effects of the pending
acquisition of Innovive on our operations and financial condition. Assuming that the acquisition
is consummated, we will need additional funds to advance any of Innovives product candidates.
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We have no significant revenue, and we expect to have no significant revenue and to continue
to incur significant losses over the next several years. Our net losses may increase from current
levels primarily due to expenses related to our ongoing and planned clinical trials, research and
development programs, possible technology acquisitions, and other general corporate activities. In
the event that actual costs of our ongoing and planned 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. We cannot assure that additional funding will be available to us on
favorable terms, or at all. If we fail to obtain additional funding when needed in the future, we
would be forced to scale back, or terminate, our operations, or to seek to merge with or to be
acquired by another company.
Our net loss, which includes non-cash charges relating to common stock, stock option and
warrants issued for services and expenses related to employee and non-employee stock options,
decreased by approximately $0.5 million during the quarter ended June 30, 2008 compared to the
quarter ended June 30, 2007. This decrease was primarily as a result of the deconsolidation of RXi
in the first quarter, resulting in no RXi expenses being included in the results for the quarter
ended June 30, 2008. Our professional fees, included in general and administrative expenses, were
approximately $470,000 higher than in the comparative 2007 period, largely relating to fees
incurred in effecting the partial spinoff of RXi.
In
the six-month period ended June 30, 2008, we used $3.4 million of cash in investing
activities, compared to $38,000 used in the comparable 2007 period. The 2008 period included $10.0
million of funds provided by RXi converting short-term investments to cash equivalents. However,
RXis cash of $10.4 million (inclusive of this $10.0 million) is no longer available due to the
deconsolidation. We advanced $2.3 million to Innovive and the remainder of the investing activity for both the 2008 and 2007 periods
primarily related to cash used for the purchase of equipment. We manage our cash, cash equivalents
and short-term investments interchangeably and at the present time do not anticipate any
significant changes to our current holdings in cash equivalents. We expect capital spending to
continue due to additional laboratory equipment necessary for our new San Diego, California,
laboratory.
Cash provided by financing activities in the six months ended June 30, 2008 and 2007 was $1.0
million and $50.2 million, respectively, which consisted exclusively of funds received from the
exercise of stock options and warrants in the 2008 period. In the six months ended June 30, 2007,
$16 million resulted from the proceeds from the exercise of stock options and warrants and $34.2
from the net proceeds from the issuance of common stock.
We are evaluating other potential future sources of capital, as 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, sales of stock of RXi,
gifts, and grants or otherwise is subject to market conditions and our 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 consolidated financial
information may not necessarily be indicative of future operating results or future financial
condition.
We expect to incur significant losses for the foreseeable future and there can be no assurance
that we will become profitable. Even if we become profitable, we may not be able to sustain that
profitability.
Results of Operations
We recorded a net loss applicable to common stockholders of approximately $5.8 million and
$12.1 million for the three-month and six-month periods ended June 30, 2008, respectively, as
compared to $6.3 million and $10.8 million for the same periods in 2007.
We recognized $1.7 million and $3.9 million of revenue for the three-month and six-month
periods ended June 30, 2008, respectively, and $2.4 million
and $3.9 million for the same periods
in 2007. These revenues relate to our $24.3 million sale to the ALSCRT of a one percent royalty
interest in worldwide sales of arimoclomol in August 2006. All future licensing fees under our
current licensing agreements are dependent upon successful development milestones being achieved by
the licensor. During 2008, we do not anticipate receiving any significant licensing fees. We will
continue to recognize the balance of the deferred revenue recorded from the royalty transaction
with the ALSCRT over the development period of our arimoclomol research.
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Research and Development
Three-Month Period | Six-Month Period | |||||||||||||||
Ended June 30, | Ended June 30, | |||||||||||||||
2008 | 2007 | 2008 | 2007 | |||||||||||||
(In thousands) | (In thousands) | |||||||||||||||
Research and development expenses |
$ | 2,225 | $ | 3,622 | $ | 5,349 | $ | 7,246 | ||||||||
Non-cash research and development expenses (recovery) |
| 3,042 | (243 | ) | 3,323 | |||||||||||
Employee stock option expense |
182 | 175 | 381 | 212 | ||||||||||||
Depreciation and amortization |
119 | 45 | 230 | 112 | ||||||||||||
$ | 2,526 | $ | 6,884 | $ | 5,717 | $ | 10,893 | |||||||||
Research expenses are expenses incurred by us in the discovery of new information that will
assist us in the creation and the development of new drugs or treatments. Development expenses are
expenses incurred by us in our efforts to commercialize the findings generated through our research
efforts.
Research and development expenses incurred during the three-month and six-month periods ended
June 30, 2008 and June 30, 2007 related primarily to (i) our Phase II clinical program for
arimoclomol in ALS, (ii) our ongoing research and development related to other molecular chaperone
amplification drug candidates, (iii) RXis acquisition of technologies covered by the UMMS license
agreements, and (iv) the small molecule drug discovery and development operations at our former
Massachusetts and new California laboratory. All research and development costs related to the
activities of RXi and our former laboratory were expensed. The three-month period ended June 30,
2008 excludes any RXi-related research and development expenses and in the six-month period ended
June 30, 2008, RXis research and development expenses are only included for the months of January
and February 2008. Our drug development efforts are subject to uncertainties inherent in any new
drug development. Due to the uncertainties involved in progressing through clinical trials, and
the time and cost involved in obtaining regulatory approval and in establishing collaborative
arrangements, among other factors, we cannot reasonably estimate the timing, completion dates, and
costs, or range of costs, of each phase of our drug development program.
As compensation to members of RXis scientific advisory board and our consultants, and in
connection with the acquisition of technology, we and RXi sometimes issue shares of common stock,
stock options and warrants to purchase shares of common stock. For financial statement purposes, we
value these shares of common stock, stock options, and warrants at the fair value of the common
stock, stock options or warrants granted, or the services received, whichever is more reliably
measurable. The value of the non-employee option grants are marked to market using the
Black-Scholes option-pricing model and most of the compensation expense recognized or recovered
during the period is adjusted accordingly. This resulted in a recovery of expenses in the
three-month and six-month periods ended June 30, 2008 totaling approximately $0 and $(243,000),
respectively, and an expense of approximately $3,042,000 and $3,323,000 for the same periods of
2007. The significant decrease in the non-cash research and development expenses for the
comparative six-month periods relates to the inclusion of RXis expenses in the 2007 period. We
recorded $182,000 and $381,000 of employee stock option expense during the three-month and
six-month periods ended June 30, 2008, as compared with $175,000 and $212,000 for the same periods
in 2007.
Over the coming twelve months, we expect our research and development expenses to increase
primarily as a result of our ongoing clinical programs for iroxanadine and arimoclomol and our drug
discovery efforts at our San Diego, California, laboratory. Those expenses will increase further if
the Innovive acquisition is completed.
General and Administrative Expenses
Three-Month Period | Six-Month Period | |||||||||||||||
Ended June 30, | Ended June 30, | |||||||||||||||
2008 | 2007 | 2008 | 2007 | |||||||||||||
(In thousands) | (In thousands) | |||||||||||||||
General and administrative expenses |
$ | 2,166 | $ | 3,534 | $ | 5,769 | $ | 5,904 | ||||||||
Non-cash general and administrative expenses |
690 | | 879 | | ||||||||||||
Employee stock option expense |
316 | 568 | 975 | 679 | ||||||||||||
Depreciation and amortization |
20 | 5 | 42 | 9 | ||||||||||||
$ | 3,192 | $ | 4,107 | $ | 7,665 | $ | 6,592 | |||||||||
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General and administrative expenses include all administrative salaries and general corporate
expenses, including legal expenses associated with the prosecution of our intellectual property.
Our general and administrative expenses, excluding stock option expense and depreciation expense,
were $2,166,000 and $5,769,000 for the three-month and six-month periods ended June 30, 2008,
respectively, compared to $3,534,000 and $5,904,000 for the same periods in 2007. General and
administrative expenses decreased by $1,368,000 in the second quarter of 2008 as compared to 2007,
primarily due to the 2007 period including approximately $700,000 of RXi expenses. Additionally,
there was a reduction in professional fees of approximately $470,000, which largely related to fees
incurred in effecting the partial spinoff of RXi in the first quarter of 2008.
Employee stock option expense relates to options granted to recruit and retain directors,
officers and other employees. We recorded approximately $316,000 and $975,000 of employee stock
option expense during the three-month and six-month periods ended June 30, 2008 as compared to
approximately $568,000 and $679,000 during the same periods in 2007. The decrease relates primarily
to the exclusion of RXis expenses in the three-months ended June 30, 2008. In June 2008, we set a
reserve of $690,000 against the loan receivable based upon the estimated recoverable value of the
underlying security and in March 2008, we awarded RXi common stock to our directors and certain
employees and recorded the $189,000 fair value as non-cash compensation expense for a total of
$879,000 for the six-months ended June 30, 2008. There were no comparable awards in the 2007
period.
Depreciation and Amortization
The depreciation expense reflects the depreciation of our equipment and furnishings and the
amortization expenses related to our molecular library, which was placed in service in March 2005.
These expenses are classified as research and development or general and administrative expenses
depending upon the associated business activity.
Interest Income
Interest income was $0.3 million and $0.8 million for the three-month and six-month periods
ended June 30, 2008, respectively, compared to $0.7 million and $1.0 million for the same periods
in 2007. The difference between periods is attributable primarily to the cash available for
investment each year.
Minority Interest in Losses of Subsidiary
We offset $88,000 of minority interest in losses of RXi against our net loss for the months of
January and February 2008. For March 2008 and for the second quarter of 2008, we did not record a
minority interest in the losses of RXi, as RXis gain and losses were accounted for under the
equity method, because following our March 11, 2008 distribution to our stockholders of RXi shares,
we owned less than 50% of RXi. We offset $176,000 and $178,000 of minority interest in losses of
RXi against our net loss for the three-month and six-month periods ended June 30, 2007,
respectively.
Income Taxes
On March 11, 2008, we distributed to our stockholders approximately 4.5 million shares of RXi
common stock. We will recognize approximately a $32.9 million gain for income tax purposes on the
distribution of shares of RXi common stock, which is the amount equal to the excess of the fair
market value of the stock distributed over our basis. The gain will be included in determining
whether we have current year earnings and profits subject to taxation. Based upon our anticipated
loss from operations for 2008 and currently available loss carryforwards, we expect to pay no
regular income taxes in connection with the distribution; however, we have recorded a tax provision
of $342,000 related to the estimated Alternative Minimum Tax resulting from this gain.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Our exposure to market risk is limited primarily to interest income sensitivity, which is
affected by changes in the general level of United States interest rates, particularly because a
significant portion of our investments are in short-term debt securities issued by the U.S.
government and institutional money market funds. The primary objective of our investment activities
is to preserve principal. Due to the nature of our short-term investments, we believe that we are
not subject to any material market risk exposure. We do not have any derivative financial
instruments or foreign currency instruments. If interest rates had varied by 10% in the three-month
period ended June 30, 2008, it would not have had a material effect on our results of operations or
cash flows for that period.
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Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial
Officer, performed an evaluation of the effectiveness of the design and operation of our disclosure
controls and procedures (as defined in Securities Exchange Act Rule 13a-15(e)) as of the end of the
quarterly period covered by this Quarterly Report. Based on that evaluation, our Chief Executive
Officer and Chief Financial Officer concluded that our disclosure controls and procedures were not
effective to ensure that information required to be disclosed by us in reports that we file or
submit under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported
within the time periods specified in the rules and forms of the SEC.
Changes in Controls over Financial Reporting
During the quarterly period covered by this Quarterly Report, we continued to make changes to
our internal controls designed to strengthen our financial reporting and disclosure controls and
procedures in light of material weaknesses in those regards reported in our Annual Report on Form
10-K for the year ended December 31, 2007 and our Quarterly Report on Form 10-Q for the quarter
ended March 31, 2008. During the quarterly period covered by this Quarterly Report, we strengthened
our managerial controls over our compliance with the established financial closing policies and
procedures. Additionally, we continued to enhance the communications among our scientific, legal
and accounting departments including the timing of and control over the flow of documents into our
legal database.
We are continuing our efforts in these regards in order to fully remedy previously reported
material weaknesses and to ensure that all of our controls and procedures are adequate and
effective. Any failure to implement and maintain improvements in the controls over our financial
reporting could cause us to fail to meet our reporting obligations under the SECs rules and
regulations. Any failure to improve our internal controls to address the weaknesses we have
identified could also cause investors to lose confidence in our reported financial information,
which could have a negative impact on the trading price of our common stock.
PART II OTHER INFORMATION
Item 1A Risk Factors
We are subject to a number of risks and uncertainties, including the risks and uncertainties
discussed below, as well as those described in our Annual Report on Form 10-K for the year ended
December 31, 2007 or reflected in any subsequent filings we make with the SEC. If any of these
risks or uncertainties actually occur, our business, results of operations, financial condition and
prospects could be materially and adversely affected. In that case, the trading price of our common
stock could decline. These risks and uncertainties are not the only ones facing us. Additional
risks and uncertainties not presently known to us, or that we currently perceive as immaterial,
also may adversely affect us.
Our common stock may be delisted from The Nasdaq Capital Market if the stock price does not
increase.
We received notice from The Nasdaq Stock Market on May 28, 2008, that our common stock had
closed below $1.00 per share for 30 consecutive business days, and we were therefore not in
compliance with the minimum bid price required by Nasdaq Marketplace Rule 4310(c)(4). In
accordance with Marketplace Rule 4310(c)(8)(D), we may regain compliance if at any time by November
24, 2008, our common stock closes at or above $1.00 for 10 consecutive business days and we
otherwise meet the Nasdaqs continuing listing requirements. Nasdaq also informed us that if we do
not regain compliance by November 24, 2008, we will be granted up to an additional 180 calendar
days to regain full compliance while continuing to trade during this time on The Nasdaq Capital
Market if at that time we meet the Nasdaqs initial listing requirements other than the minimum bid
price rule. If we eventually fail to comply with this condition for continued listing and our
common stock is delisted from The Nasdaq Small Capital Market, there is no assurance that our
common stock will be listed for trading or quoted elsewhere and an active trading market for our
common stock may cease to exist, which would materially and adversely impact the market value of
our common stock.
Because we have no source of significant recurring revenue, we must depend on financing to
sustain our operations.
Developing products and conducting clinical trials require substantial amounts of capital. To
date, we have relied primarily upon proceeds from sales of our equity securities and the exercise
of options and warrants, and to a much lesser extent, upon payments from our strategic partners and
licensees, to generate funds needed to finance our business and operations. We will need to raise
additional capital to, among other things:
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| fund our clinical trials and pursue regulatory approval of our existing and possible future product candidates; | ||
| expand our research and development activities; | ||
| finance our general and administrative expenses; | ||
| acquire or license other technologies; | ||
| prepare, file, prosecute, maintain, enforce and defend our patent and other proprietary rights; and | ||
| develop and implement sales, marketing and distribution capabilities to successfully commercialize any product for which we obtain marketing approval and which we choose to market itself. |
Our revenues were approximately $7.5 million, $2.1 million and $0.2 million, respectively, for
years ended December 31, 2007, 2006 and 2005, and approximately $1.7 million and $3.9 million for
the three and six months ended June 30, 2008, respectively. Our revenues for the years ended
December 31, 2007 and 2006 and the three and six months ended June 30, 2007 included approximately
$7.2 million, $1.9 million, $2.4 million and $3.8 million, respectively, of deferred revenue
recognized from our sale in August 2006 of a one percent royalty interest in worldwide sales of
arimoclomol for the treatment of ALS. We will have no significant recurring revenue unless we are
able to commercialize one or more of our product candidates in development, which may require us to
first enter into license or other strategic arrangements with third parties.
At June 30, 2008, we had cash, cash equivalents and short-term investments of approximately
$36.4 million. We believe that our current resources will be sufficient to support our currently
planned level of operations into the second half of 2009. This estimate is based, in part, upon
our currently projected expenditures for the remainder of 2008 and the first six months of 2009 of
approximately $26.4 million, including approximately $1.8 million of direct expenditures for our
planned clinical program for arimoclomol for ALS and related studies, approximately $0.3 million of
direct expenditures for our planned clinical program for arimoclomol for stroke recovery and
related studies, approximately $8.0 million of direct expenditures for our planned Phase II
clinical trial of iroxanadine for diabetic ulcers and related studies, approximately $8.1 million
for the operations of our research laboratory in San Diego, California, and approximately $8.2
million for other general and administrative expenses. Our projected expenditures are based on our
recently announced plan to conduct additional animal toxicology studies prior to the resumption of
our Phase II clinical program for arimoclomol for ALS that currently is on clinical hold by the FDA
and prior to any initiation of our Phase II clinical trial for arimoclomol for stroke recovery.
Those animal toxicology studies are expected to take approximately one year. These projected
expenditures are based upon numerous other assumptions and subject to many uncertainties, and our
actual expenditures may be significantly different from these projections. These projected
expenditures also do not consider the effects of the pending acquisition of Innovive on our
operations and financial condition. Assuming that the acquisition is completed, we will need
additional funds to advance any of Innovives product candidates.
If we obtain marketing approval as currently planned and successfully commercialize our
current product candidates, we anticipate it will take a minimum of three years, and possibly
longer, for us to generate significant recurring revenue, and we will be dependent on future
financing until such time, if ever, as we can generate significant recurring revenue. We have no
commitments from third parties to provide us with any additional financing, and we may not be able
to obtain future financing on favorable terms, or at all. If we raise additional funds by issuing
equity securities, dilution to our then-existing stockholders may result and new investors could
have rights superior to holders of our common stock. In addition, debt financing, if available,
may include restrictive covenants. If adequate funds are not available to us, we may have to
liquidate some or all of our assets or delay or reduce the scope of or eliminate some portion or
all of our development programs or clinical trials. We also may have to license to other companies
its product candidates or technologies that we would prefer to develop and commercialize ourselves.
The FDA has placed a clinical hold on CytRxs Phase IIb efficacy trial of arimoclomol, which
will delay the trial and could lead to a requirement that CytRx conduct additional toxicology
studies or alter the trial design.
In January 2008, the FDA placed a clinical hold on our Phase IIb clinical efficacy trial of
arimoclomol for the treatment of ALS due to concerns relating to previous toxicology studies of
arimoclomol in rats. We received a formal determination letter from the FDA in July 2008. In light
of the ongoing clinical hold, we recently announced plans to conduct additional preclinical
toxicology studies of arimoclomol, which are expected to take up to one year to complete, before any possible
resumption or initiation of clinical trials of arimoclomol. We cannot predict the outcome of those
additional animal toxicology studies. Depending on the outcome, we may be:
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| required to conduct additional toxicology or human studies prior to or in parallel with the resumption of our clinical trial, which would result in substantial additional expenses and possible significant delays in completing the clinical trial; | ||
| required to alter the design including reducing the dosage of arimoclomol, of the clinical trial, which could significantly delay the completion of the trial, increase the cost of the trial, adversely affect our ability to demonstrate the efficacy of arimoclomol in the trial or cause us to cancel the trial altogether due to one or more of these considerations; or | ||
| prohibited by the FDA from resuming our current planned clinical trial or initiating any other clinical trial of arimoclomol for the treatment of ALS or any other indication due to safety concerns. |
Our development of arimoclomol for stroke recovery is subject to similar risks.
Risks Associated with the Innovive Merger
There is no guarantee that the merger will be completed.
The merger with Innovive is subject to a number of conditions, including approval by Innovive
stockholders. There is no assurance that the merger will be approved or that the other conditions
to the completion of the merger will be satisfied. If the merger is not completed, we will need to
reconsider and revise the recent changes to our business strategy or to undertake another strategic
transaction in furtherance of our current strategy.
We will incur increased losses as a result of the merger, which may adversely affect our stock
price.
We will incur significant transaction costs in connection with the merger. In addition, we
expect to incur additional costs, which cannot be precisely estimated at this time, of integrating
Innovives business and operations into ours. These costs will result in increased losses to us in
the immediate future, which could have an adverse effect on the market price of our common stock.
We may not achieve the benefits we expect from the merger, which may have a material adverse
effect on us.
We entered into the merger agreement with the expectation that the merger will result in
benefits to us. Among other benefits, we believe that our development of Innovives existing
product candidates may accelerate the time to market of our first product candidate. If we are not
successful in achieving this or other expected benefits of the merger, our future prospects may be
adversely affected.
If the merger is not completed, we may not be repaid for our advances to Innovive under the
loan and security agreement.
As of August 6, 2008, we had advanced to Innovive under the loan and security agreement a
total of approximately $2.7 million, and Innovive may request additional advances of up to
approximately $2.8 million pending the merger. If the merger is not completed, our advances under
the loan and security agreement, plus accrued interest, will become immediately due and payable by
Innovive. Innovive, however, has no commitments or arrangements for any financing to repay such
advances, so we expect that it would be unable to repay such advances if the merger agreement is
not completed. In this event, we would be entitled to pursue all of our remedies under the loan
and security agreement, including the possible foreclosure sale of all or substantially all of
Innovives assets, but there is no assurance that these remedies would be effective to repay all of
the amounts that will be owing to us by Innovive.
If the merger is not consummated by September 30, 2008, either we or Innovive may choose not
to proceed with the merger.
Either we or Innovive may terminate the merger agreement if the merger has not been completed
by September 30, 2008, unless the failure of the merger to be completed by such date has resulted
from the failure of the party seeking to terminate the merger agreement to perform its obligations
or the failure of the condition regarding effectiveness of the registration statement filed by us
with the Securities and Exchange Commission relating to the merger.
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Item 4. Submission of Matters to a Vote of Security Holders
On July 1, 2008, we held our Annual Meeting of Stockholders. The following are the results of
voting on the proposals:
a) Election of directors:
Nominee | For | Withheld | ||||||
Steven A. Kriegsman |
71,624,371 | 3,298,229 | ||||||
Marvin R. Selter |
70,887,580 | 4,035,020 | ||||||
Richard L. Wennekamp |
70,868,209 | 4,054,391 |
b) Approval of an amendment to our Restated Certificate of Incorporate to increase the
authorized number of shares of common stock from 150,000,000 to 175,000,000:
For |
68,557,152 | |||
Against |
6,059,517 | |||
Abstain |
305,929 |
c) Ratification of the selection of BDO Seidman, LLP as our independent auditors:
For |
74,100,790 | |||
Against |
462,917 | |||
Abstain |
358,892 |
Item 6. Exhibits
The exhibits listed in the accompanying Index to Exhibits are filed as part of this Quarterly
Report on Form 10-Q and incorporated herein by reference.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
CYTRX CORPORATION (Registrant) |
||||
Date: August 11, 2008 | By: | /s/ MITCHELL K. FOGELMAN | ||
Mitchell K. Fogelman | ||||
Chief Financial Officer (Principal Financial Officer) |
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INDEX TO EXHIBITS
Exhibit | ||
Number | Description | |
10.1
|
Amendment to Stockholders Agreement, dated July 28, 2008, among CytRx Corporation, RXi Pharmaceuticals Corporation, and Michael P. Czech, PhD., Gregory J. Hannon, Ph.D., Craig C. Mello, PhD., and Tariq M. Rana, Ph.D. | |
10.2
|
Amendment to Contribution Agreement, dated July 28, 2008, between CytRx Corporation and RXi Pharmaceuticals Corporation | |
31.1
|
Certification of Chief Executive Officer Pursuant to 17 CFR 240.13a-14(a) | |
31.2
|
Certification of Chief Financial Officer Pursuant to 17 CFR 240.13a-14(a) | |
32.1
|
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | |
32.2
|
Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
26