10-Q/A 06-30-06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q/A
Amendment No. 1
|
|
|
þ |
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2006
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
|
|
58-1642740 |
(State or other jurisdiction
of incorporation or organization)
|
|
(I.R.S. Employer Identification No.) |
|
|
|
11726 San Vicente Blvd.
Suite 650
Los Angeles, CA
(Address of principal executive offices)
|
|
90049
(Zip Code) |
Registrants telephone number, including area code: (310) 826-5648
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the Registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer.
Large accelerated filer o Accelerated filer o Non-accelerated filer þ
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12(b)-2 of the
Exchange Act). Yes o No þ
There were 76,788,694 shares of CytRx Corporation Common Stock, $.001 par value, issued
and outstanding as of March 23, 2007, exclusive of treasury shares.
EXPLANATORY NOTE
CytRx Corporation (the Company) is amending in certain respects its Quarterly Report on Form
10-Q for the quarter year ended June 30, 2006, which we sometimes refer to in this amendment as our
original Form 10-Q. The purpose of this amendment is to restate our condensed consolidated
financial statements for the quarter ended June 30, 2006 as described below.
The restatement of our condensed consolidated financial statements is related to a
reclassification of certain expenses related to the operations of our Massachusetts laboratory.
The restatement also includes a correction of the accounting for historical anti-dilution
adjustments in certain of our outstanding warrants in the quarters ended June 30, 2006 and 2005,
respectively.
On March 30, 2007, the Audit Committee of our Board of Directors approved managements
recommendation to restate our condensed consolidated financial statements for the quarter ended
June 30, 2006 to reflect the expense reclassification and the correction of the accounting for
historical anti-dilution adjustments in certain of our outstanding warrants.
The following Items and Exhibits of our original Form 10-Q are amended by this amendment:
|
|
|
Part I Item 1. Financial Statements (unaudited) |
|
|
|
|
Part I Item 2. Managements Discussion and Analysis of Financial Condition and
Results of Operations |
|
|
|
|
Part I Item 4. Controls and Procedures |
|
|
|
|
Part II Item 6. Exhibits |
|
|
|
|
Exhibit 31.1 Certification of Chief Executive Officer |
|
|
|
|
Exhibit 31.2 Certification of Chief Financial Officer |
Except for the foregoing Items and Exhibits, this amendment does not modify any disclosures
contained in our original Form 10-Q. Additionally, the text of this amendment, except for the
restatement information, speaks as of the filing date of the original Form 10-Q and does not
attempt to update the disclosures in our original Form 10-Q or to discuss any developments
subsequent to the date of the original filing. In accordance with the rules and regulations of the
Securities and Exchange Commission, the information contained in the original Form 10-Q and this
amendment is subject to updated or supplemental information contained in reports filed by us with
the Securities and Exchange Commission subsequent to the filing dates of the original Form 10-Q and
this amendment.
CYTRX CORPORATION
Form 10-Q
Table of Contents
Part
I FINANCIAL INFORMATION
Item 1. Financial Statements
CYTRX CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
13,243,535 |
|
|
$ |
8,299,390 |
|
Accounts receivable |
|
|
|
|
|
|
172,860 |
|
Prepaid compensation, current portion |
|
|
|
|
|
|
27,813 |
|
Prepaid and other current assets |
|
|
176,731 |
|
|
|
287,793 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
13,420,266 |
|
|
|
8,787,856 |
|
Equipment and furnishings, net |
|
|
285,714 |
|
|
|
352,641 |
|
Molecular library, net |
|
|
328,216 |
|
|
|
372,973 |
|
Prepaid insurance and other assets |
|
|
402,532 |
|
|
|
425,440 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
14,436,728 |
|
|
$ |
9,938,910 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,510,039 |
|
|
$ |
815,626 |
|
Accrued expenses and other current liabilities |
|
|
1,432,395 |
|
|
|
1,639,922 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
2,942,434 |
|
|
|
2,455,548 |
|
Deferred revenue |
|
|
275,000 |
|
|
|
275,000 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
3,217,434 |
|
|
|
2,730,548 |
|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Preferred Stock, $.01 par value, 5,000,000
shares authorized, including 5,000 shares of
Series A Junior Participating Preferred
Stock; no shares issued and outstanding |
|
|
|
|
|
|
|
|
Common stock, $.001 par value, 125,000,000
shares authorized; 70,619,000 and 59,284,000
shares issued at June 30, 2006 and December
31, 2005, respectively |
|
|
70,619 |
|
|
|
59,284 |
|
Additional paid-in capital |
|
|
145,910,693 |
|
|
|
131,790,932 |
|
Treasury stock, at cost (633,816 shares held
at June 30, 2006 and December 31, 2005,
respectively) |
|
|
(2,279,238 |
) |
|
|
(2,279,238 |
) |
Accumulated deficit |
|
|
(132,482,780 |
) |
|
|
(122,362,616 |
) |
|
|
|
|
|
|
|
Total stockholders equity |
|
|
11,219,294 |
|
|
|
7,208,362 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
14,436,728 |
|
|
$ |
9,938,910 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
1
CYTRX CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
|
|
(restated) |
|
|
|
|
|
|
(restated) |
|
|
(restated) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service revenue |
|
$ |
|
|
|
$ |
|
|
|
$ |
60,830 |
|
|
$ |
|
|
License fees |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
60,830 |
|
|
|
1,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (includes
$61,000 and $105,000 of non-cash
stock-based compensation given to
consultants for the three and six-month
periods ended June 30, 2006 and $38,000
and $90,000 of non-cash stock-based
compensation given to consultants for
the three and six-month periods ended
June 30, 2005, respectively) |
|
|
3,096,293 |
|
|
|
2,915,969 |
|
|
|
5,269,941 |
|
|
|
4,829,989 |
|
Depreciation and amortization |
|
|
80,010 |
|
|
|
62,288 |
|
|
|
138,941 |
|
|
|
100,412 |
|
General and administrative (includes
$58,000 and $125,000 of non-cash
stock-based compensation given to
consultants for the three and six-month
periods ended June 30, 2006 and $77,000
and $316,000 of non-cash stock-based
compensation given to consultants for
the three and six-month periods ended
June 30, 2005) |
|
|
2,114,776 |
|
|
|
1,614,695 |
|
|
|
3,871,705 |
|
|
|
3,271,907 |
|
Expense related to employee stock options |
|
|
351,209 |
|
|
|
|
|
|
|
696,378 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,642,288 |
|
|
|
4,592,952 |
|
|
|
9,976,965 |
|
|
|
8,202,308 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before other income |
|
|
(5,642,288 |
) |
|
|
(4,592,952 |
) |
|
|
(9,916,135 |
) |
|
|
(8,200,808 |
) |
Other income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
176,908 |
|
|
|
41,066 |
|
|
|
284,398 |
|
|
|
83,730 |
|
Minority interest in losses of subsidiary |
|
|
|
|
|
|
42,753 |
|
|
|
|
|
|
|
81,452 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(5,465,380 |
) |
|
$ |
(4,509,133 |
) |
|
$ |
(9,631,737 |
) |
|
$ |
(8,035,626 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Deemed dividend for anti-dilution adjustments
made to outstanding common stock warrants |
|
|
|
|
|
|
|
|
|
|
(488,429 |
) |
|
|
(1,075,568 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common stockholders |
|
$ |
(5,465,380 |
) |
|
$ |
(4,509,133 |
) |
|
$ |
(10,120,166 |
) |
|
$ |
(9,111,194 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted loss per share, as originally stated |
|
$ |
(0.08 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.14 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share, as restated |
|
$ |
(0.08 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.16 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding |
|
|
69,977,876 |
|
|
|
57,542,340 |
|
|
|
66,181,900 |
|
|
|
55,509,421 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
CYTRX
CORPORATION
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
|
2006 |
|
|
2005 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(9,631,737 |
) |
|
$ |
(8,035,626 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
138,941 |
|
|
|
100,412 |
|
Minority interest in losses of subsidiary |
|
|
|
|
|
|
(81,452 |
) |
Common stock, stock options and warrants issued for services |
|
|
230,547 |
|
|
|
406,483 |
|
Expense related to employee stock options |
|
|
696,378 |
|
|
|
|
|
Net change in operating assets and liabilities |
|
|
788,796 |
|
|
|
575,956 |
|
|
|
|
|
|
|
|
Total adjustments |
|
|
1,854,662 |
|
|
|
1,001,399 |
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(7,777,075 |
) |
|
|
(7,034,227 |
) |
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(22,335 |
) |
|
|
(34,489 |
) |
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(22,335 |
) |
|
|
(34,489 |
) |
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Net proceeds from exercise of stock options and warrants |
|
|
339,194 |
|
|
|
251,619 |
|
Net proceeds from issuances of common stock |
|
|
12,404,360 |
|
|
|
19,590,446 |
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
12,743,554 |
|
|
|
19,842,065 |
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
|
4,944,144 |
|
|
|
12,773,349 |
|
Cash and cash equivalents at beginning of period |
|
|
8,299,390 |
|
|
|
2,999,409 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
13,243,534 |
|
|
$ |
15,772,758 |
|
|
|
|
|
|
|
|
Non-Cash Financing Activities:
In connection with the Companys adjustment to the terms of certain outstanding warrants on
January 20, 2005 and March 2, 2006, the Company recorded deemed dividends of $1,075,568 and
$488,429, respectively, which were recorded as charges to retained earnings with a corresponding
credit to additional paid-in capital.
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
CYTRX CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2006
(Unaudited)
1. Description of Company and Basis of Presentation
CytRx Corporation (CytRx or the Company) is a biopharmaceutical research and development
company, based in Los Angeles, California, with an obesity and type 2 diabetes research laboratory
in Worcester, Massachusetts (see Note 11 to our financial statements for the year ended December
31, 2005). On September 30, 2005, the Company completed the merger of CytRx Laboratories, Inc.,
previously a wholly owned subsidiary of the Company and the owner of its Massachusetts laboratory
(the Subsidiary), with and into the Company. The Companys small molecule therapeutics efforts
include the clinical development of three, oral drug candidates that it acquired in October 2004,
as well as a drug discovery operation conducted by its laboratory in Worcester, Massachusetts. The
Company owns the rights to a portfolio of technologies, including ribonueleic acid interference
(RNAi or gene silencing) technology in the treatment of specified diseases, including those within
the areas of amyotrophic lateral sclerosis (ALS or Lou Gehrigs disease), obesity and type 2
diabetes and human cytomegalovirus (CMV). In addition, the Company announced that a novel HIV DNA +
protein boost vaccine exclusively licensed to the Company and developed by researchers at
University of Massachusetts Medical School and Advanced BioScience Laboratories, and funded by the
National Institutes of Health, demonstrated promising interim Phase I clinical trial results that
indicate its potential to produce potent antibody responses with neutralizing activity against
multiple HIV viral strains. The Company has entered into strategic alliances with third parties to
develop several of the Companys other products.
In 2004, the Company began a development program based on molecular chaperone co-induction
technology through the acquisition of novel small molecules with broad therapeutic applications in
neurology, type 2 diabetes, cardiology and diabetic complications. The acquired assets included
three oral, clinical stage drug candidates and a library of 500 small molecule drug candidates. In
September 2005, the Company entered the clinical stage of drug development with the initiation of a
Phase II clinical program with its lead small molecule product candidate arimoclomol for the
treatment of ALS. The Company completed dosing and patient follow-up for that clinical trial in
July 2006. Arimoclomol has received Orphan Drug and Fast Track designation from the U.S. Food and
Drug Administration.
To date, the Company has relied primarily upon selling equity securities and, to a much lesser
extent, upon payments from its strategic partners and licensees and upon proceeds received upon the
exercise of options and warrants to generate the funds needed to finance its operations. Management
believes the Companys cash and cash equivalents balances are sufficient to meet projected cash
requirements into the third quarter of 2007. The Company will be required to obtain significant
additional funding in order to execute its long-term business plans, although it does not currently
have commitments from any third parties to provide it with capital. The Company cannot assure that
additional funding will be available on favorable terms, or at all. If the Company fails to obtain
significant additional funding when needed, it may not be able to execute its business plans and
its business may suffer, which would have a material adverse effect on its financial position,
results of operations and cash flows.
The accompanying condensed consolidated financial statements at June 30, 2006 and for the
three and six-month periods ended June 30, 2006 and 2005 are unaudited, but include all
adjustments, consisting of normal recurring entries, which the Companys management believes to be
necessary for a fair presentation of the periods presented. Interim results are not necessarily
indicative of results for a full year. Balance sheet amounts as of December 31, 2005 have been
derived from our audited financial statements as of that date.
4
The financial statements included herein have been prepared by the Company pursuant to the
rules and regulations of the Securities and Exchange Commission (SEC). Certain information and
footnote disclosures normally included in financial statements prepared in accordance with
accounting principles generally accepted in the U.S. have been condensed or omitted pursuant to
such rules and regulations. The financial statements should be read in conjunction with the
Companys audited financial statements in its Form 10-K for the year ended December 31, 2005. The
Companys operating results will fluctuate for the foreseeable future. Therefore, period-to-period
comparisons should not be relied upon as predictive of the results in future periods.
The accompanying condensed financial statements have been restated to reflect a
reclassification of certain expenses related to the operations of the Companys Massachusetts
laboratory and a correction of the accounting for the Companys historical anti-dilution
adjustments in certain of its outstanding warrants. The statement of operations was restated to
include deemed dividends of $1,075,568 and $488,429 in the first quarters of 2005 and 2006,
respectively, in arriving at the net loss applicable to common stockholders of $9,111,194 and
$10,120,166 for the six-month periods ended June 30, 2005 and 2006, respectively. The restated net
loss applicable to common stockholders resulted in an increase in net loss per share from $0.14 to
$0.16 for the six-month period ended June 30, 2005, but did not change the net loss per share of
$0.15 for the same period in 2006. The statement of operations was also restated to reflect
$408,593 and $882,123 of expenses that were reclassified from general and administrative expense to research and
development expense for the three and six-month periods ended June 30, 2006, respectively.
2. Recent Accounting Pronouncements
In June 2006, the Financial Accounting Standards Board (FASB) issued FASB Interpretation No.
(FIN) 48, Accounting for Uncertainty in Income Taxes, which clarifies the accounting for
uncertainty in income taxes recognized in an entitys financial statements in accordance with FASB
Statement No. 109, Accounting for Income Taxes. FIN 48 prescribes a recognition threshold and
measurement attribute for the financial statement recognition and measurement of a tax position
taken or expected to be taken in a tax return. In addition, FIN 48 provides guidance on
derecognition, classification, interest and penalties, accounting in interim periods, disclosure
and transition. FIN 48 is effective for fiscal years beginning after December 15, 2006. The Company
is currently in a loss position and does not pay income taxes; therefore the adoption of FIN 48 is
not expected to have a significant impact on the Companys 2006 financial statements.
3. Loss Per Share
Basic
net loss per share is computed using the weighted-average number of common shares
outstanding during the period. Diluted net loss per share is computed using the weighted-average
number of common shares and dilutive potential common shares outstanding during the period.
Dilutive potential common shares primarily consist of employee stock options and restricted common
stock. Common share equivalents which potentially could dilute basic
loss per share in the
future, and which were excluded from the computation of diluted loss per share, as the effect would
be anti-dilutive, totaled approximately 29,224,000 and 24,890,000 shares at June 30, 2006 and 2005,
respectively.
Statement of Financial Accounting Standards No. 128, Earnings per Share (SFAS 128)
requires that employee equity share options, nonvested shares and similar equity instruments
granted by the Company be treated as potential common shares outstanding in computing diluted
loss per share. As the Company recorded losses for the three and six-month periods ended June
30, 2006, all employee equity share options, nonvested shares and similar equity instruments would
be anti-dilutive. In the event the Company becomes profitable, diluted shares outstanding will
include the dilutive effect of in-the-money options which are calculated based on the average share
price for each fiscal period using the treasury stock method. Under the treasury stock method, the
amount the employee must pay for exercising stock options, the amount of compensation cost for
future service that the Company has not yet recognized, and the amount of benefits that would be
recorded in additional paid-in capital when the award becomes deductible are assumed to be used to
repurchase shares.
In connection with our adjustment to the exercise terms of certain outstanding warrants to
purchase common stock on March 2, 2006 and January 20, 2005, we recorded deemed dividends of
$488,000 and $1.1 million, respectively. These deemed dividends are reflected as an adjustment to
net loss for the six-month periods ended June 30, 2006 and 2005, respectively, to arrive at net
loss applicable to common stockholders on the condensed consolidated statement of operations and for purposes
of calculating basic and diluted loss per share.
4. Stock Based Compensation
On January 1, 2006, the Company adopted Statement of Financial Accounting Standards No. 123
(revised 2004), Share-Based Payment, (SFAS 123(R)) which requires the measurement and
recognition of compensation expense for all share-based payment awards made to employees and
directors, including employee stock options, based on estimated fair values. SFAS 123(R) supersedes
the Companys previous accounting under Accounting
5
Principles Board Opinion No. 25, Accounting for Stock Issued to Employees (APB 25),
employed by the Company for periods prior to fiscal 2006. In March 2005, the Securities and
Exchange Commission issued Staff Accounting Bulletin No. 107 (SAB 107) relating to SFAS 123(R).
The Company has applied the provisions of SAB 107 in its adoption of SFAS 123(R).
The Companys Consolidated Financial Statements as of and for the three and six-month periods
ended June 30, 2006 reflect the impact of SFAS 123(R). In accordance with the modified prospective
transition method, the Companys Consolidated Financial Statements for prior periods have not been
restated to reflect, and do not include, the impact of SFAS 123(R). Stock-based compensation
expense recognized under SFAS 123(R) as general and administrative expense for the three and
six-month periods ended June 30, 2006 were approximately $351,000 and $696,000, respectively. There
was no stock-based compensation expense related to employee stock options and employee stock
purchases recognized during the three and six-month periods ended June 30, 2005.
As of June 30, 2006, an aggregate of 10,000,000 shares of common stock were reserved for
issuance under the Companys 2000 Stock Option Incentive Plan, including 6,478,000 shares subject
to outstanding stock options and 3,159,000 shares available for future grant. Additionally, the
Company has two other plans, the 1994 Stock Option Plan and the 1998 Long Term Incentive Plan,
which include 31,000 and 100,000 shares subject to outstanding stock options. As the terms of our
plans provide that no options may be issued after 10 years, no options are available under the 1994
Plan. Under the 1998 Plan Long Term Incentive Plan, 40,000 shares are available for future grant.
Options granted under these plans generally vest and become exercisable as to 33% of the option
grants on each anniversary of the grant date until fully vested. The options will expire, unless
previously exercised, not later than ten years from the grant date.
In December 2004, the Financial Accounting Standards Board (FASB) issued Statement of
Accounting Standard (SFAS) No. 123R, Share-Based Payment, an amendment of FASB Statements Nos.
123 and 95 (SFAS 123R), that addresses the accounting for, among other things, transactions in
which a company receives employee services in exchange for equity instruments of the company. The
statement precludes accounting for employee share-based compensation transactions using the
intrinsic method, and requires that such transactions be accounted for using a fair-value-based
method and that the fair value of the transaction be recognized as expense on a straight-line basis
over the vesting period. In March 2005, the SEC issued Staff Accounting Bulletin (SAB) No. 107
(SAB 107) regarding the Staffs interpretation of SFAS 123R. This interpretation provides the
Staffs views regarding interactions between SFAS 123R and certain SEC rules and regulations and
provides interpretations of the valuation of share-based payments for public companies.
SFAS 123(R) requires companies to estimate the fair value of share-based payment awards on the
date of grant using an option-pricing model. The value of the portion of the award that is
ultimately expected to vest is recognized as expense over the requisite service periods in the
Companys Consolidated Statement of Operations. Prior to the adoption of SFAS 123(R), the Company
accounted for stock-based awards to employees and directors using the intrinsic value method in
accordance with APB 25 as allowed under Statement of Financial Accounting Standards No. 123,
Accounting for Stock-Based Compensation (SFAS 123). Under the intrinsic value method, no
stock-based compensation expense had been recognized in the Companys Consolidated Statement of
Operations, other than as related to acquisitions and investments, because the exercise price of
the Companys stock options granted to employees and directors equaled the fair market value of the
underlying stock at the date of grant.
Stock-based compensation expense recognized during the period is based on the value of the
portion of share-based payment awards that is ultimately expected to vest during the period.
Stock-based compensation expense recognized in the Companys Consolidated Statement of Operations
for the first six months of fiscal 2006 included compensation expense for share-based payment
awards granted prior to, but not yet vested as of, January 1, 2006, based on the grant date fair
value estimated in accordance with the pro forma provisions of SFAS 123, and compensation expense
for the share-based payment awards granted subsequent to January 1, 2006 based on the grant date
fair value estimated in accordance with the provisions of SFAS 123(R). In conjunction with the
adoption of SFAS 123(R), the Company adopted the straight-line single option method. As stock-based
compensation expense
6
recognized in the Consolidated Statement of Operations for the first six months of fiscal 2006
is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures. SFAS
123(R) requires forfeitures to be estimated at the time of grant and revised, if necessary, in
subsequent periods if actual forfeitures differ from those estimates. In the Companys pro forma
information required under SFAS 123 for the periods prior to fiscal 2006, the Company accounted for
forfeitures as they occurred.
Upon adoption of SFAS 123(R), the Company elected to continue to use the Black-Scholes
option-pricing model (Black-Scholes model). The Companys determination of fair value of
share-based payment awards on the date of grant using an option-pricing model is affected by the
Companys stock price as well as assumptions regarding a number of highly complex and subjective
variables. These variables include, but are not limited to, the Companys expected stock price
volatility over the term of the awards, and actual and projected employee stock option exercise
behaviors. Option-pricing models were developed for use in estimating the value of traded options
that have no vesting or hedging restrictions and are fully transferable. Because the Companys
employee stock options have certain characteristics that are significantly different from traded
options, and because changes in the subjective assumptions can materially affect the estimated
value, in managements opinion, the existing valuation models may not provide an accurate measure
of the fair value of the Companys employee stock options. Although the fair value of employee
stock options is determined in accordance with SFAS 123(R) and SAB 107 using an option-pricing
model, that value may not be indicative of the fair value observed in a willing buyer/willing
seller market transaction.
Prior to January 1, 2006, the Company accounted for its stock based compensation plans under
the recognition and measurement provisions of Accounting Principles Board No. 25, Accounting for
Stock Issued to Employees (APB 25), and related interpretations for all awards granted to
employees. Under APB 25, when the exercise price of options granted to employees under these plans
equals the market price of the common stock on the date of grant, no compensation expense is
recorded. When the exercise price of options granted to employees under these plans is less than
the market price of the common stock on the date of grant, compensation expense is recognized over
the vesting period.
For stock options paid in consideration of services rendered by non-employees, the Company
recognizes compensation expense in accordance with the requirements of SFAS No. 123 and EITF 96-18,
as amended, and Emerging Issues Task Force Issue No. 96-18, Accounting for Equity Instruments that
are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or
Services. Under SFAS No. 123, the compensation associated with stock options paid to non-employees
is generally recognized in the period during which services are rendered by such non-employees.
Since our adoption of SFAS 123(R), there been no change to our equity plans or modifications of our
outstanding stock-based awards.
Deferred compensation for non-employee option grants that do not vest immediately upon grant
are recorded as an expense over the vesting period of the underlying stock options, using the
method prescribed by FASB Interpretation 28. At the end of each financial reporting period prior to
vesting, the value of these options, as calculated using the Black Sholes option pricing model,
will be re-measured using the fair value of the Companys common stock and deferred compensation
and the non-cash compensation recognized during the period will be adjusted accordingly. Since the
fair market value of options granted to non-employees is subject to change in the future, the
amount of the future compensation expense is subject to adjustment until the stock options are
fully vested. The Company recognized $119,000 and $231,000 of stock based compensation expense
related to non-employee stock options for the three and six-month periods ended June 30, 2006,
respectively.
7
The following table illustrates the pro forma effect on net loss and net loss per share
assuming the Company had applied the fair value recognition provisions of SFAS 123 to options
granted under the Companys stock option plans for the three and six-month periods ended June 30,
2005. For purposes of this presentation, the value of the options is estimated using a Black Sholes
option-pricing model and recognized as an expense on a straight-line basis over the options
vesting periods.
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, 2005 |
|
|
June 30, 2005 |
|
|
|
|
|
|
|
(restated) |
|
Net loss allocable to common stockholders |
|
$ |
(4,509 |
) |
|
$ |
(9,111 |
) |
Total stock-based employee
compensation expense determined under
fair-value based method for all awards |
|
|
(350 |
) |
|
|
(657 |
) |
|
|
|
|
|
|
|
Pro forma net loss |
|
$ |
(4,859 |
) |
|
$ |
(9,768 |
) |
|
|
|
|
|
|
|
Loss per share, as originally reported (basic and diluted) |
|
$ |
(0.08 |
) |
|
$ |
(0.14 |
) |
|
|
|
|
|
|
|
Loss per share, as restated (basic and diluted) |
|
$ |
(0.08 |
) |
|
$ |
(0.16 |
) |
|
|
|
|
|
|
|
Loss per share, pro forma (basic and diluted) |
|
$ |
(0.08 |
) |
|
$ |
(0.18 |
) |
|
|
|
|
|
|
|
The fair value of stock options at the date of grant was estimated using the Black-Sholes
option-pricing model, based on the following assumptions: The Companys expected stock price
volatility assumption is based upon the historical daily volatility of our publicly traded stock.
For option grants issued during the six-month period ended June 30, 2006 the Company used a
calculated volatility for each grant. The expected life assumptions is based upon the simplified
method provided for under SAB 107, which averages the contractual term of the Companys options of
ten years with the average vesting term of two years for an average of six years. The dividend
yield assumption is based upon the fact the Company has never paid cash dividends and presently has
no intention of paying cash dividends. The risk-free interest rate used for each grant is equal to
the U.S. Treasury rates in effect at the time of the grant for instruments with a similar expected
life. Based on historical experience, the Company has estimated an annualized forfeiture rate of
10% for options granted to its employees and 3% for its senior
management and director stock
options. The Company will record additional expense if the actual forfeitures are lower than
estimated and will record a recovery of prior expense if the actual forfeiture rates are higher
than estimated. Under provisions of SFAS 123(R), the Company recorded $351,000 and $696,000 of
stock-based compensation for the three and six-month periods ended June 30, 2006, respectively. No
amounts relating to employee stock-based compensation have been capitalized.
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
June 30, 2006 |
|
June 30, 2005 |
Risk-free interest rate |
|
|
4.27% 5.23 |
% |
|
|
3.58% 4.33 |
% |
Expected volatility |
|
|
117.0 |
% |
|
|
119.1 |
% |
Expected lives (years) |
|
|
6 |
|
|
|
6 |
|
Expected dividend yield |
|
|
0.00 |
% |
|
|
0.00 |
% |
At June 30, 2006, there remained approximately $3.7 million of unrecognized compensation
expense related to unvested employee stock options to be recognized as expense over a
weighted-average period of 8.48 years. Presented below is the Companys stock option activity:
|
|
|
|
|
|
|
|
|
|
|
Stock Options |
|
|
Six Months Ended |
|
|
June 30, 2006 |
|
|
|
|
|
|
Weighted Average |
|
|
Number |
|
Exercise Price |
|
|
of Shares |
|
per Share |
Outstanding at beginning of year |
|
|
6,205,542 |
|
|
$ |
1.71 |
|
Granted |
|
|
553,500 |
|
|
$ |
1.36 |
|
Exercised |
|
|
(62,500 |
) |
|
$ |
0.96 |
|
Forfeited |
|
|
(87,500 |
) |
|
$ |
2.07 |
|
|
|
|
|
|
|
|
|
|
Outstanding at end of year |
|
|
6,609,042 |
|
|
$ |
1.69 |
|
|
|
|
|
|
|
|
|
|
Shares exercisable at end of period |
|
|
4,016,911 |
|
|
$ |
1.86 |
|
|
|
|
|
|
|
|
|
|
8
A summary of the activity for nonvested stock options as of June 30, 2006 and changes during
the six month period is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Number |
|
Grant Date Fair |
|
|
of Shares |
|
Value per Share |
Nonvested at January 1, 2006 |
|
|
2,767,385 |
|
|
$ |
1.47 |
|
Granted |
|
|
553,500 |
|
|
$ |
1.36 |
|
Vested |
|
|
(728,754 |
) |
|
$ |
1.59 |
|
|
|
|
|
|
|
|
|
|
Nonvested at June 30, 2006 |
|
|
2,592,131 |
|
|
$ |
1.42 |
|
|
|
|
|
|
|
|
|
|
The following table summarizes significant ranges of outstanding stock options under the three
plans at June 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
|
|
|
Number of |
|
|
|
|
Range of |
|
|
|
|
|
Contractual Life |
|
Weighted Average |
|
Options |
|
Weighted Average |
|
Weighted Average |
Exercise Prices |
|
Number of Options |
|
(years) |
|
Exercise Price |
|
Exercisable |
|
Contractual Life |
|
Exercise Price |
$0.25 1.00
|
|
|
1,236,043 |
|
|
|
7.92 |
|
|
$ |
0.82 |
|
|
|
521,904 |
|
|
|
6.66 |
|
|
$ |
0.82 |
|
$1.01 1.50
|
|
|
1,437,500 |
|
|
|
8.98 |
|
|
|
1.29 |
|
|
|
544,670 |
|
|
|
4.91 |
|
|
|
1.27 |
|
$1.51 2.00
|
|
|
2,222,500 |
|
|
|
7.55 |
|
|
|
1.86 |
|
|
|
1,454,170 |
|
|
|
6.69 |
|
|
|
1.86 |
|
$2.01 3.00
|
|
|
1,712,999 |
|
|
|
7.12 |
|
|
|
2.43 |
|
|
|
1,496,167 |
|
|
|
7.23 |
|
|
|
2.44 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,609,042 |
|
|
|
7.82 |
|
|
$ |
1.69 |
|
|
|
4,016,911 |
|
|
|
6.65 |
|
|
$ |
1.86 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate intrinsic value of outstanding options as of June 30, 2006, was $710,000 of
which $84,000 is related to exercisable options. The aggregate intrinsic value was calculated based
on the positive difference between the closing fair market value of the Companys common stock on
June 30, 2006 ($1.32) and the exercise price of the underlying options. The intrinsic value of
options exercised was $2,100 and $55,550 for the three and six month periods ended June 30, 2006
and the intrinsic value of options vested was $26,000 and $97,000 during these same periods.
5. Liquidity and Capital Resources
Based on the Companys currently planned level of expenditures, it believes that it will have
adequate working capital to allow it to operate at its currently planned levels into the third
quarter of 2007. The Company will be required to obtain significant additional funding in order to
execute its business plans. The Company is pursuing several potential sources of capital, including
potential strategic alliances, although it does not currently have commitments from any third
parties to provide it with capital.
6. Equity Transactions
On March 2, 2006, the Company completed a $13.4 million private equity financing in which it
issued 10,650,794 shares of its common stock and warrants to purchase an additional 5,325,397
shares of its common stock at an exercise price of $1.54 per share.
Net of investment banking commissions, legal, accounting and other expenses related to the
transaction, we received proceeds of approximately $12.4 million.
In connection with the financing, the Company adjusted the price and number of underlying
shares of warrants to purchase approximately 2.8 million shares that had been issued in prior
equity financings in May and September 2003. The adjustment was made as a result of anti-dilution
provisions in those warrants that were triggered by the Companys issuance of common stock in that
financing at a price below the closing market price on the date of the transaction. The Company
accounted for the anti-dilution adjustments as deemed dividends analgous with the guidance in
Emerging Issues Task Force Issue (EITF) No. 98-5, Accounting for Convertible Securities with
Beneficial Conversion Features or Contingently Adjustable Conversion Ratios, and EITF 00-27,
Application of 98-5 to Certain Convertible Instruments, and recorded an approximate $488,000 charge
to retained earnings and a corresponding credit to additional paid-in capital.
9
In connection with March equity financing, the Company entered into a registration rights
agreement with the purchasers of its stock and warrants, which provides, among other things, for
cash penalties in the event that the Company were unable to initially register, or maintain the
effective registration of, the securities. The Company evaluated the penalty provisions in light of
EITF 00-19, Accounting for Derivative Financial Instruments Indexed To, and Potentially Settled In
a Companys Own Stock, and determined that the maximum penalty does not exceed the difference
between the fair value of a registered share of CytRx common stock and unregistered share of Cytrx
common stock on the date of the transaction. Further, the Companys management evaluated the other
terms of the March 2006 financing with the provisions of EITF 00-19 and related accounting
literature. Management concluded based upon its analysis of EITF 00-19 and related accounting
literature, the common stock and related warrants sold in the March 2006 financing should be
recorded as permanent equity in its financial statements.
During the three and six-month periods ended June 30, 2006, the Company issued 41,072 and
683,903 shares of its common stock, and received $4,968 and $339,193, upon the exercise of stock
options and warrants. In addition to the warrants issued in the March 2006 financing described
above, the Company issued 450,000 and 553,500 options and warrants in the three and six-month
period ended June 30, 2006.
Item 2. Managements Discussion and Analysis of Financial Condition And Results of Operations
Forward Looking Statements
From time to time, we make oral and written statements that may constitute forward-looking
statements (rather than historical facts) as defined in the Private Securities Litigation Reform
Act of 1995 or by the Securities and Exchange Commission, or SEC, in its rules, regulations and
releases, including Section 27A of the Securities Act of 1933, as amended and Section 21E of the
Securities Exchange Act of 1934, as amended. We desire to take advantage of the safe harbor
provisions in the Private Securities Litigation Reform Act of 1995 for forward-looking statements
made from time to time, including, but not limited to, the forward-looking statements made in this
Quarterly Report on Form 10-K, as well as those made in other filings with the SEC.
All statements in this Quarterly Report, including in Managements Discussion and Analysis of
Financial Condition and Results of Operations, other than statements of historical fact are
forward-looking statements for purposes of these provisions, including any projections of financial
items, any statements of the plans and objectives of management for future operations, any
statements concerning proposed new products or services, any statements regarding future economic
conditions or performance, and any statement of assumptions underlying any of the foregoing. In
some cases, forward-looking statements can be identified by the use of terminology such as may,
will, expects, plans, anticipates, estimates, potential or could or the negative
thereof or other comparable terminology. Although we believe that the expectations reflected in the
forward-looking statements contained herein and in documents incorporated by this Quarterly Report
are reasonable, there can be no assurance that such expectations or any of the forward-looking
statements will prove to be correct, and actual results could differ materially from those
projected or assumed in the forward-looking statements.
Our future financial condition and results of operations, as well as any forward-looking
statements, are subject to inherent risks and uncertainties, including but not limited to the risk
factors set forth under the heading Risk Factors in this Quarterly Report. These risks and
uncertainties include: the scope of the clinical testing that may be required by regulatory
authorities for our molecular chaperone co-induction drug candidates, including with respect to
arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrigs disease), our
HIV vaccine candidate and our other product candidates, and the outcomes of those tests;
uncertainties related to the early stage of our diabetes, obesity, cytomegalovirus, or CMV, and ALS
research; the need for future clinical testing of any small molecules and products based on
ribonucleic acid interference, or RNAi, that may be developed by us; the significant time and
expense that will be incurred in developing any of the potential commercial applications for our
small molecules or RNAi technology; risks or uncertainties related to our ability to obtain capital
to fund our ongoing working capital needs, including capital required to fund RNAi development
activities that we plan to
10
conduct through the creation of a new subsidiary; and risks relating to the enforceability of
any patents covering our products and to the possible infringement of third party patents by those
products.
All forward-looking statements and reasons why results may differ included in this Quarterly
Report are made as of the date hereof, and we assume no obligation to update any such
forward-looking statement or reason why actual results might differ.
Overview
We are a biopharmaceutical research and development company, based in Los Angeles, California,
with an obesity and type 2 diabetes research laboratory in Worcester, Massachusetts. We are in the
process of developing products, primarily in the areas of small molecule therapeutics and
ribonucleic acid interference, or RNAi, for the human health care market. Our small molecule
therapeutics efforts include clinical development of three oral drug candidates that we acquired in
October 2004, including a Phase II trial initiated in September 2005, as well as drug discovery
operations conducted at our laboratory in Worcester, Massachusetts. RNAi is a relatively recent
technology for silencing genes in living cells and organisms, and we are aware of only four
clinical tests of therapeutic applications using RNAi that have been initiated by any party. In
addition to our work in RNAi and small molecule therapeutics, we recently announced that a novel
HIV DNA + protein vaccine exclusively licensed to us and developed by researchers at the University
of Massachusetts Medical School, or UMMS, and Advanced BioScience Laboratories, and funded by the
National Institutes of Health, demonstrated promising interim Phase I clinical trial results that
indicate its potential to produce potent antibody responses with neutralizing activity against
multiple HIV viral strains. We have also entered into strategic alliances with respect to the
development of several other products using our other technologies.
In 2004, we began a development program based on molecular chaperone co-induction technology
through the acquisition of novel small molecules with broad therapeutic applications in neurology,
type 2 diabetes, cardiology and diabetic complications. The acquired assets included three oral,
clinical stage drug candidates and a library of 500 small molecule drug candidates. In September
2005, we entered the clinical stage of drug development with the initiation of a Phase II clinical
program with our lead small molecule product candidate arimoclomol for the treatment of amyotrophic
lateral sclerosis (ALS or Lou Gehrigs disease). We completed dosing and patient follow-up for that
clinical trial in July 2006. Arimoclomol has received Orphan Drug and Fast Track designation from
the U.S. Food and Drug Administration, or FDA.
The initial Phase II clinical trial that we have initiated for arimoclomol for ALS (which we
refer to as the Phase IIa trial) is a multicenter, double-blind, placebo-controlled study of
approximately 80 ALS patients enrolled at ten clinical centers across the U.S. Patients received
either placebo (a capsule without drug), or one of three dose levels of arimoclomol capsules three
times daily, for a period of 12 weeks. This treatment phase is followed by a one-month period
without drug. The primary endpoints of this Phase IIa trial are safety and tolerability. Secondary
endpoints include a preliminary evaluation of efficacy using two widely accepted surrogate markers,
the revised ALS Functional Rating Scale (ALSFRS-R), which is used to determine patients capacity
and independence in 13 functional activities, and Vital Capacity (VC), an assessment of lung
capacity. The trial is powered to monitor only extreme responses in these two categories. We have
also announced initiation of an open-label (i.e., the medication is no longer blinded to the
patients or their doctor) extension of this clinical trial. Patients who complete the Phase IIa
study and who still meet the eligibility criteria may have the opportunity to take arimoclomol, at
the highest investigative dose, for as long as an additional 6 months.
Depending upon the results of the Phase IIa trial, we plan to initiate a subsequent Phase II
trial (which we refer to as the Phase IIb trial) that will be powered to detect more subtle
efficacy responses. Although this second trial is still in the planning stages and will be subject
to FDA approval, it is expected to include approximately 390 ALS patients recruited from
approximately 30 clinical sites, and will take approximately 18 months after initiation to
complete.
11
Our molecular chaperone co-induction technology represents a continuation of our business
strategy, adopted subsequent to our merger with Global Genomics, in July 2002, to conduct further
research and development efforts for our pre-merger adjuvant and co-polymer technologies, including
Flocor and Tranzfect, through strategic relationships with other pharmaceutical companies, and to
focus our efforts on acquiring and developing new technologies and products to serve as the
foundation for the future of the company.
In April 2003, we acquired our first new technologies by entering into exclusive license
agreements with UMMS covering potential applications for its proprietary RNAi technology in the
treatment of specified diseases and in the identification and screening of novel protein targets.
In May 2003, we broadened our strategic alliance with UMMS by acquiring an exclusive license from
it covering a proprietary DNA-based HIV vaccine technology. In July 2004, we further expanded our
strategic alliance with UMMS by entering into a collaboration and invention disclosure agreement
with UMMS under which UMMS will disclose to us certain new technologies developed at UMMS over a
three-year period pertaining to RNAi, diabetes, obesity, neurodegenerative diseases (including ALS)
and CMV, and will give us an option, upon making a specified payment, to negotiate an exclusive
worldwide license to the disclosed technologies on commercially reasonable terms. Approximately one
year remains on the technology disclosure option. As part of our strategic alliance with UMMS, we
agreed to fund certain discovery and pre-clinical research at UMMS relating to the use of our
technologies, licensed from UMMS, for the development of therapeutic products within certain
fields.
In conjunction with some of our work with UMMS, we operate a research and development
laboratory in Worcester, Massachusetts whose goal is to develop small molecule and RNAi-based
therapeutics for the prevention, treatment and cure of obesity and type 2 diabetes. This laboratory
is focusing on using our proprietary RNAi gene silencing technology, combined with genomic and
proteomic based drug discovery technologies, to accelerate the process of screening and identifying
potential proprietary drug targets and pathways for these diseases. Through this laboratory, we are
seeking to develop orally active drugs against promising targets and pathways relevant to obesity
and type 2 diabetes. We are currently pursuing a plan, subject to obtaining necessary funding, to
transfer all of our RNAi therapeutics assets into a newly-formed subsidiary to accelerate the
development and commercialization of drugs based on RNAi technology. In such event, we would
continue to use our RNAi gene silencing technology as a drug discovery tool to facilitate our small
molecule drug discovery program.
Although we intend to internally fund the early stage development work for certain product
applications (including obesity, type 2 diabetes and ALS) and may seek to fund the completion of
the development of certain of these product applications (such as arimoclomol for ALS), we may also
seek to secure strategic alliances or license agreements with larger pharmaceutical or
biotechnology companies to fund the early stage development work for other gene silencing product
applications and for subsequent development of those potential products where we fund the early
stage development work.
We have no significant revenue, and we expect to have no significant revenue and to continue
to incur significant losses over the next several years. Our net losses may increase from current
levels primarily due to activities related to our collaborations, technology acquisitions, ongoing
and planned clinical trials, research and development programs and other general corporate
activities. We anticipate that our operating results will fluctuate for the foreseeable future.
Therefore, period-to-period comparisons should not be relied upon as predictive of the results in
future periods.
To date, we have relied primarily upon sales of equity securities and, to a much lesser
extent, upon payments from our strategic partners and licensees and upon proceeds received upon the
exercise of options and warrants, to generate the funds needed to finance our business plans and
operations. We will be required to obtain significant additional funding in order to execute our
long-term business plans. Our sources of potential funding for the next several years are expected
to consist primarily of proceeds from sales of equity, but could also include license and other
fees, funded research and development payments, gifts and grants, and milestone payments under
existing and future collaborative arrangements. However, we have no commitment or arrangements for
such additional funding.
Restatement
The accompanying condensed financial statements have been restated to reflect a
reclassification of certain expenses related to the operations of our Massachusetts laboratory and
a correction of the accounting for our historical anti-dilution adjustments in certain of its
outstanding warrants. The statement of operations was restated to include deemed dividends of
$1,075,568 and $488,429 in the first quarters of 2005 and 2006, respectively, in arriving at the
net loss applicable to common stockholders of $9,111,194 and $10,120,166 for the six-month periods
ended June 30, 2005 and 2006, respectively. The restated net loss applicable to common
stockholders resulted in an increase in net loss per share from $0.14 to $0.16 for the six-month
period ended June 30, 2005, but did not change the net loss per share of $0.15 for the same period
in 2006. The statement of operations was also restated to reflect $408,593 and $882,123 of expenses that were
reclassified from general and administrative expense to research and development expense for the
three and six-month periods ended June 30, 2006, respectively.
12
Critical Accounting Policies and Estimates
Managements discussion and analysis of our financial condition and results of operations are
based on our consolidated financial statements, which have been prepared in accordance with
accounting principles generally accepted in the United States. The preparation of these financial
statements requires management to make estimates and judgments that affect the reported amounts of
assets, liabilities, revenue and expenses, and related disclosure of contingent assets and
liabilities. On an ongoing basis, management evaluates its estimates, including those related to
revenue recognition, bad debts, impairment of long-lived assets, including finite lived intangible
assets, accrued liabilities and certain expenses. We base our estimates on historical experience
and on various other assumptions that are believed to be reasonable under the circumstances, the
results of which form the basis for making judgments about the carrying values of assets and
liabilities that are not readily apparent from other sources. Actual results may differ materially
from these estimates under different assumptions or conditions.
Our significant accounting policies are summarized in Note 2 to our financial statements
contained in our Annual Report on Form 10-K filed for the year ended December 31, 2005. We believe
the following critical accounting policies affect our more significant judgments and estimates used
in the preparation of our consolidated financial statements:
Revenue Recognition
Nonrefundable license fee revenue is recognized when collectibility is reasonably assured,
which is generally upon receipt, when no continuing involvement on our part is required and payment
of the license fee represents the culmination of the earnings process. Nonrefundable license fees
received subject to future performance by us or that are credited against future payments due to us
are deferred and recognized as services are performed and collectibility is reasonably assured,
which is generally upon receipt, or upon termination of the agreement and all related obligations
thereunder, whichever is earlier. Our revenue recognition policy may require us to defer
significant amounts of future revenue.
Research and Development Expenses
Research and development expenses consist of costs incurred for direct and overhead-related
research expenses and are expensed as incurred. Costs to acquire technologies which are utilized in
research and development and which have no alternative future use are expensed when incurred.
Technology developed for use in our products is expensed as incurred, until technological
feasibility has been established. Expenditures, to date, have been classified as research and
development expense in the consolidated statements of operations, and we expect to continue to
expense research and development for the foreseeable future.
Stock-based Compensation
Effective January 1, 2006, we adopted the provisions of SFAS 123(R), Share-Based Payment
(SFAS 123(R)), which revises SFAS No. 123, Accounting for Stock-Based Compensation, and
supersedes Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees.
SFAS 123(R) requires that companies recognize compensation expense associated with stock option
grants and other equity instruments to employees in the financial statements. SFAS 123(R) applies
to all grants after the effective date and to the unvested portion of stock options outstanding as
of the effective date. The pro forma disclosures previously permitted under SFAS 123 are no longer
an alternative to financial statement recognition. We are using the modified-prospective method and
the Black-Scholes valuation model for valuing the share-based payments. We will continue to account
for transactions in which services are received in exchange for equity instruments based on the
fair value of such services received from non-employees, in accordance with SFAS 123 and Emerging
Issues Task Force (EITF) Issue No. 96-18, Accounting for Equity Instruments that Are Issued to
Other than Employees for Acquiring, or in Conjunction with Selling, Goods or Services.
13
Impairment of Long-Lived Assets
We review long-lived assets, including finite lived intangible assets, for impairment on an
annual basis, as of December 31, or on an interim basis if an event occurs that might reduce the
fair value of such assets below their carrying values. An impairment loss would be recognized based
on the difference between the carrying value of the asset and its estimated fair value, which would
be determined based on either discounted future cash flows or other appropriate fair value methods.
Facility Abandonment
During 2005, we entered into a termination agreement related to the lease for our former
Atlanta headquarters. Pursuant to this agreement, we were released from all future obligations on
the lease in exchange for a one-time $110,000 payment and the forfeiture of a $49,000 security
deposit. As a result of this agreement, we realized a $164,000 offset against our 2005 third
quarter general and administrative expenses.
Recent Accounting Pronouncements
In June 2006, the Financial Accounting Standards Board (FASB) issued FASB Interpretation No.
(FIN) 48, Accounting for Uncertainty in Income Taxes, which clarifies the accounting for
uncertainty in income taxes recognized in an entitys financial statements in accordance with FASB
Statement No. 109, Accounting for Income Taxes. FIN 48 prescribes a recognition threshold and
measurement attribute for the financial statement recognition and measurement of a tax position
taken or expected to be taken in a tax return. In addition, FIN 48 provides guidance on
derecognition, classification, interest and penalties, accounting in interim periods, disclosure
and transition. FIN 48 is effective for fiscal years beginning after December 15, 2006. We are
currently in a loss position and do not pay income taxes; therefore the adoption of FIN 48 is not
expected to have a significant impact on our 2006 financial statements.
Liquidity and Capital Resources
At June 30, 2006, we had cash and cash equivalents of $13.2 million and total assets of $14.4
million, compared to $8.3 million and $9.9 million, respectively, at December 31, 2005. Working
capital totaled $10.5 million at June 30, 2006, compared to $6.3 million at December 31, 2005.
To date, we have relied primarily upon sales of equity securities and, to a much lesser
extent, payments from our strategic partners and licensees and upon proceeds received upon the
exercise of options and warrants, to generate funds needed to finance our business and operations.
As a result of the $12.4 million equity financing (net of expenses) that we completed in March
2006, we believe that we have adequate working capital to support our currently planned level of
operations into the third quarter of 2007, including our current and planned clinical trials for
arimoclomol and drug discovery efforts related to additional product candidates. Included in our
planned expenses are approximately $1.0 million for our Phase II clinical program with arimoclomol
for ALS during the remainder of 2006, and an additional $4.0 million in 2007 and $9.1 million in
2008. The cost of our clinical program for ALS, which we estimate will total approximately $19.8
million from inception to completion, could vary significantly from our current projections due to
any additional requirements imposed by the FDA in connection with the ongoing Phase IIa trial, or
in connection with our planned Phase IIb trial, or if actual costs are higher than current
management estimates for other reasons. In the event that actual costs of our clinical program for
ALS, or any of our other ongoing research activities, are significantly higher than our current
estimates, we may be required to significantly modify our planned level of operations. In the
future, we will be dependent on obtaining financing from third parties in order to maintain our
operations, including our Phase II clinical program with arimoclomol for ALS, our planned levels of
operations for our obesity and type 2 diabetes research laboratory and our ongoing research and
development efforts related to our other small molecule drug candidates, and in order to continue
to meet our obligations to UMMS. Additionally, we expect to spend approximately $300,000 related to
our efforts to comply with the requirements of Section 404 of the Sarbanes Oxley Act of 2002.
14
We currently have no commitments from any third parties to provide us with capital. We cannot
assure that additional funding will be available to us on favorable terms, or at all. If we fail to
obtain additional funding when needed, we would be forced to scale back, or terminate, our
operations, or to seek to merge with or to be acquired by another company.
In the six-month periods ended June 30, 2006 and 2005, net cash used in investing activities
consisted of approximately $22,000 and $34,000, respectively, for the purchase of equipment. We
expect capital spending to increase during the remainder of 2006 to support our increasing research
and development efforts and efforts to comply with the requirements of Section 404 of the Sarbanes
Oxley Act of 2002.
Cash provided by financing activities in the six-month period ended June 30, 2006 was $12.7
million. The cash provided includes approximately $339,000 received from the exercise of stock
options and warrants. Additionally, we received approximately $12.4 million, net of expenses,
through a private equity financing that closed in March 2006. Cash provided by financing activities
in the six month period ended June 30, 2005 was $19.8 million. During this period, we raised $19.6
million, net of expenses,- from the issuance of common stock in a private equity financing in
January 2005, and we received proceeds from the exercise of stock options and warrants totaling
$252,000.
Our net loss for the six-month period ended June 30, 2006 was $9.6 million, which resulted in
net cash used in operating activities of $7.8 million. Adjustments to reconcile net loss to net
cash used in operating activities for the six-month period ended June 30, 2006 were primarily
$696,000 of employee stock option expense incurred related to our implementation of SFAS 123(R),
and $231,000 of common stock, options and warrants expense issued in lieu of cash for general and
administrative services and $139,000 of depreciation expense, which was off-set by a $789,000
change in operating assets and liabilities. Our net loss for the six month period ended June 30,
2005 was $8.0 million, which resulted in net cash used in operating activities of $7.0 million.
Adjustments to reconcile net loss to net cash used in operating activities for the six-month period
ended June 30, 2005 were primarily $406,000 of common stock, options and warrants issued in lieu of
cash for general and administrative services, the recording of $100,000 depreciation expense, and a
$576,000 change in operating assets and liabilities. In 2005, we were not required to record
expense per SFAS 123(R) guidance, however, we were required to use pro-forma presentation for the
expense related to issuances of stock options and warrants to employees.
We believe that we have adequate working capital to allow us to operate at our currently
planned levels into the third quarter of 2007. Our strategic alliance with UMMS may require us to
make significant expenditures to fund research at UMMS relating to developing therapeutic products
based on UMMSs proprietary gene silencing technology that has been licensed to us. The aggregate
amount of these expenditures under certain circumstances is expected to be approximately $1,030,000
during 2006, of which $766,000 had been expensed through June 30, 2006.
We will require significant additional capital in order to fund the completion of our Phase II
clinical program with our lead small molecule product candidate arimoclomol for the treatment of
ALS, which commenced in September 2005, and the other ongoing research and development related to
our other molecular chaperone co-induction drug candidates. We incurred $2.6 million on the
arimoclomol clinical program in the first six months of 2006, and we estimate that the overall
program, including the ongoing Phase IIa trial and the planned Phase IIb trial that we expect to
initiate after completion of the present Phase IIa trial subject to FDA approval, will require us
to expend an additional $1.0 million in the remainder of 2006, and an additional $13.1 million over
the following 24 months. However, we may incur substantial additional expense and the trial may be
delayed if the FDA requires us to generate additional pre-clinical or clinical data in connection
with the clinical trial, or the FDA requires us to revise significantly our planned protocol for
the Phase IIb.
Additional capital may be provided by potential milestone payments pursuant to our licenses
with Merck and Vical, both of which relate to Tranzfect, or our license with SynthRx related to
Flocor, or by potential payments from future strategic alliance partners or licensees of our
technologies. However, Merck is at an early stage of
15
clinical trials of a product utilizing TransFect and Vical has only recently commenced a Phase
IIa clinical trial of a product using TransFect, so it is likely to be a substantial period of
time, if ever, before we receive any further significant payments from Merck or Vical.
We are pursuing other sources of capital, although we do not currently have commitments from
any third parties to provide us with capital. The results of our technology licensing efforts and
the actual proceeds of any fund-raising activities will determine our ongoing ability to operate as
a going concern. Our ability to obtain future financings through joint ventures, product licensing
arrangements, equity financings, gifts, and grants or otherwise are 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 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 of $5.5 and $9.6 million for the three and six-month periods ended June
30, 2006, respectively, as compared to $4.5 million and $8.0 million for the same periods in 2005.
We earned no licensing fees and an immaterial amount of service revenue during the three and
six-month periods ended June 30, 2006. We earned an immaterial amount of licensing fees during the
three and six-month periods ended June 30, 2005. All future licensing fees under our current
licensing agreements are dependent upon successful development milestones being achieved by the
licensor. During fiscal 2006, we are not anticipating receiving any significant licensing fees.
In 2006, we expect our research and development expenses to increase primarily as a result of
our ongoing Phase II clinical program with arimoclomol and related studies for the treatment of
ALS. We incurred $2.6 million on the arimoclomol clinical program in the first six months of 2006,
and we estimate that the overall program, including the ongoing Phase IIa trial and the planned
Phase IIb trial that we expect to initiate after completion of the present Phase IIa trial subject
to FDA approval, will require us to expend an additional $1.0 million in the remainder of 2006, and
an additional $13.1 million over the following 24 months. Additionally, we estimate that our costs
related to the activities of our Massachusetts laboratory will remain consistent with 2005
expenditures.
Research and development expenses were $3.1 and $5.3 million during the three and six-month
periods ended June 30, 2006, as compared to $2.9 and $4.8 million for the same periods in 2005.
Research and development expenses incurred during the first six months of 2006 and 2005 related
primarily to (i) the preparation for and initiation of our Phase II clinical program for
arimoclomol in ALS, (ii) our ongoing research and development related to our other molecular
chaperone co-induction drug candidates, (iii) our research and development activities conducted at
UMMS related to the technologies covered by the UMMS license agreements, (iv) our collaboration and
invention disclosure agreement pursuant to which UMMS has agreed to disclose certain inventions to
us and provide us with the right to acquire an option to negotiate exclusive licenses for those
disclosed technologies, and (v) the on-going small molecule drug discovery operations at our
Massachusetts laboratory. Although our future research and development activities could vary
substantially, our research and development activities will remain substantial in the future as a
result of commitments related to the foregoing activities.
In each of the periods presented in the accompanying condensed consolidated statements of
operations, certain vesting criteria of stock options issued to consultants were achieved,
resulting in aggregate non-cash charges for research and development activities of $61,000 and
$105,000 during the three and six-month periods ended June 30, 2006 and $38,000 and $90,000 for the
same periods ended June 30, 2005.
16
All research and development costs related to the activities of our laboratory are expensed.
No in-process research and development costs were eligible for capitalization at the time we
purchased the minority interest in our prior subsidiary, CytRx Laboratories.
Depreciation and amortization expense was $80,000 and $139,000 during the three and six-month
periods ended June 30, 2006, as compared to $62,000 and $100,000 for the same periods in 2005. The
amounts in 2006 and 2005 primarily relate to depreciation of fixed assets located at our
Massachusetts laboratory and the amortization of the molecular screening library acquired in 2004,
which was put into service in March of 2005.
From time to time, we issue shares of our common stock or warrants to purchase shares of our
common stock to consultants and other service providers in exchange for services. For financial
statement purposes, we value these shares of common stock, stock options, or warrants at the fair
market value of the common stock, stock options or warrants granted, or the services received,
whichever is more reliably measurable, and we recognize the expense in the period in which a
performance commitment exists or the period in which the services are received, whichever is
earlier. During each of the periods presented in the accompanying condensed consolidated statements
of operations, certain vesting criteria of stock options and warrants issued to consultants were
achieved, resulting in aggregate non-cash charges for general and administrative activities of
$58,000 and $125,000 for the three and six-month periods ended June 30, 2006, respectively, and
$77,000 and $316,000 for the three and six-month periods ended June 30, 2005. In addition, for the
six-month period ended June 30, 2006, we recorded $696,000 of employee stock option expense in
accordance with SFAS 123(R), for which there was no corresponding expense recorded in prior
periods.
General and administrative expenses incurred were $2.1 and $3.9 million for the three and
six-month periods ended June 30, 2006, as compared to $1.6 and $3.3 million for the same periods in
2005. The expenses incurred during the three and six-month periods ended June 30, 2006 increased
slightly in the second quarter due to legal fees, travel and licensing fees. We anticipate general
and administrative expenses to increase over the remainder of 2006 as a result of, among other
things, our efforts to comply with the requirements of Section 404 of the Sarbanes Oxley Act of
2002, and continuing employee stock option expense as a result of our implementation of SFAS
123(R).
Interest income was $177,000 and $284,000 for the three and six-month periods ended June 30,
2006, as compared to $41,000 and $84,000 for the same period in 2005. The increase in interest
income was due to the higher rates on our cash and investments that were held during 2006 compared
to the lower rates in the same period in 2005.
For 2006, we did not record any minority interest share of our losses because, on June 30,
2005, we repurchased the outstanding 5% interest in CytRx Laboratories from Dr. Michael Czech, and
on September 30, 2005, we completed our merger with CytRx Laboratories. For the six months ended
June 30, 2005, we recorded a $81,000 reduction to our losses as a result of the minority interest
share in the losses of CytRx Laboratories. This amount is reported as a separate line item in the
accompanying condensed consolidated statements of operations.
Related Party Transactions
Dr. Michael Czech, a 5% minority shareholder of CytRx Laboratories until June 30, 2005 and a
member of our Scientific Advisory Board, is an employee of UMMS and is the principal investigator
for a sponsored research agreement between CytRx and UMMS. During the six-month periods ended June
30, 2006 and 2005, we incurred expenses to UMMS related to Dr. Czechs sponsored research agreement
of $201,000 and $402,000, respectively. Additionally, we paid $40,000 to Dr. Czech for his services
on the Scientific Advisory Board for each of these periods.
17
Item 4 Controls and Procedures
Evaluations of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial
Officer, performed an evaluation of the effectiveness of the design and operation of our disclosure
controls and procedures (as defined in Securities Exchange Act Rule 13a-15(e)) as of June 30, 2006,
the end of the period covered by our original Form 10-Q. Based on that evaluation, our Chief
Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures
were effective to ensure that information required to be disclosed by us in reports that we file or
submit under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported
within the time periods specified in the rules and forms of the SEC.
Subsequently, in conjunction with the preparation of our Annual Report on Form 10-K for the
year ended December 31, 2006, our management, with the participation of our Chief Executive Officer
and Chief Financial Officer, identified other deficiencies, discussed below, that it considered to
be material weaknesses (a) in the effectiveness of our internal controls over financial reporting
related to the application of generally accepted accounting principles arising from our accounting
for historical warrant anti-dilution adjustments as deemed dividends, and (b) in the effectiveness
of our internal controls over quarterly and annual financial statement reporting arising from our
accounting for research and development expenses related to our laboratory facility in Worcester,
Massachusetts. Pursuant to standards established by the Public Company Accounting Oversight Board,
a material weakness is a significant deficiency or combination of significant deficiencies that
results in more than a remote likelihood that a material misstatement of the annual or interim
financial statements will not be presented or detected.
In May and September of 2003, we completed private placements of securities that included
warrants to purchase approximately 2.8 million shares of our common stock. These warrants contain
provisions for anti-dilution adjustments based upon future sales of our common stock or common
stock equivalents at an effective price per share below the prevailing market price of our common
stock at the time of the sale. We subsequently completed private placement transactions in January
2005 and in March 2006 involving our sale of securities at prices which triggered the foregoing
anti-dilution adjustments to the warrants in question, and we recorded those adjustments as deemed
dividends. Based upon a reevaluation of our historical accounting for those anti-dilution
adjustments, management determined that, by analogy to the guidance provided by SFAS No. 128,
Earnings Per Share, the deemed dividends should be subtracted from our net earnings (loss) (i.e.,
added to our net loss) to arrive at net loss allocable to common stockholders and for the purpose
of calculating our net earnings (loss) per share.
In addition, until the third quarter of 2005, our laboratory facility was operated by our
subsidiary, CytRx Laboratories, Inc. (CytRx Labs). CytRx Labs maintained a separate accounting
system, although the general ledger accounts in its system and our accounting system were
identically numbered. On September 30, 2005, CytRx Labs was merged into CytRx, and we continued to
operate the laboratory as an integrated part of CytRx.
In the first quarter of 2006, for the sake of administrative efficiency, CytRx Labs general
ledger system was integrated into our general ledger system by combining the laboratorys general
ledger accounts with our identically numbered accounts. In the process, expenses of the laboratory
relating to rent, payroll and related employee benefits, which should properly have been classified
as research and development expenses due to the nature of our activities carried on at the
laboratory, were improperly classified as general and administrative expenses and reported as such
on the original Form 10-Q, because they were combined with corresponding accounts of CytRx, whose
corporate offices and personnel are devoted primarily to administrative activities.
Based on that evaluation of the effectiveness of the design and operation of our disclosure
controls and procedures, and solely because of corrections referred to above, our Chief Executive
Officer and Chief Financial Officer concluded that our disclosure controls and procedures over our
accounting for research and development
18
expenses related to our laboratory facility and our accounting for warrant anti-dilution
adjustments were not effective as of June 30, 2006.
The weakness regarding the reclassification of research and development expenses related
specifically to the manner in which we integrated the former separate accounting system of our
laboratory facility. Having completed our review and evaluation of the integration in connection
with the preparation of our annual financial statements for 2006, we believe that the remediation
of this weakness also has been completed. We additionally intend to pursue additional actions to
enhance internal review of all equity transactions to ensure the effectiveness of all aspects of
our controls related to the accounting for anti-dilution adjustments to our outstanding warrants
and other securities.
Changes in Controls Over Financial Reporting
During the quarterly period covered by this Form 10-Q, we made changes to our internal control
designed to strengthen our financial reporting relating to disclosures of stock-based compensation
in light of a material weakness in this regards reported in our Form 10-Q for the quarter ended
March 31, 2006. During the quarterly period covered by this Form 10-Q, we fully implemented new
software for accounting for stock options. We also re-assigned certain responsibilities related to
the input and maintenance of stock options records and enhanced our internal review of all
stock-based compensation awards and other equity transactions.
We continuously seek to improve and strengthen our control processes to ensure that all of our
controls and procedures are adequate and effective. Any failure to implement and maintain
improvements in the controls over our financial reporting could cause us to fail to meet our
reporting obligations under the Securities and Exchange Commissions rules and regulations. Any
failure to improve our internal controls to address the weakness we have identified could also
cause investors to lose confidence in our reported financial information, which could have a
negative impact on the trading price of our common stock.
19
PART II OTHER INFORMATION
Item 6.
Exhibits
The exhibits listed in the accompanying Index to Exhibits are filed as part of this Quarterly
Report on Form 10-Q.
20
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this amendment to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
CYTRX CORPORATION
(Registrant)
|
|
Date: April 2, 2007 |
By: |
/s/ MATTHEW NATALIZIO
|
|
|
|
Matthew Natalizio |
|
|
|
Chief Financial Officer
(Principal Financial Officer) |
|
21
INDEX TO EXHIBITS
|
|
|
|
|
Exhibit |
|
|
|
|
Number |
|
|
|
Description |
10.1 *
|
|
x
|
|
Second Amended and Restated Employment Agreement dated June 16, 2006 between CytRx
Corporation and Dr. Jack Barber |
|
|
|
|
|
10.2 *
|
|
x
|
|
Second Amended and Restated Employment Agreement dated June 16, 2006 between CytRx
Corporation and Matthew Natalizio |
|
|
|
|
|
10.3 *
|
|
x
|
|
Second Amended and Restated Employment Agreement dated June 16, 2006 between CytRx
Corporation and Benjamin S. Levin |
|
|
|
|
|
10.4 *
|
|
x
|
|
Schedule of Non-Employee Director Compensation adopted on June 20, 2006 |
|
|
|
|
|
31.1
|
|
|
|
Certification of Chief Executive Officer Pursuant to 15 U.S.C. Section 7241, as adopted
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
|
|
31.2
|
|
|
|
Certification of Chief Financial Officer Pursuant to Section 15 U.S.C. Section 7241, as
adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002 |
|
|
|
|
|
32.1
|
|
x
|
|
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
|
|
32.2
|
|
x
|
|
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
* |
|
Indicates a management contract or compensatory plan or arrangement. |
|
x |
|
Previously filed. |
22