10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d)
OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2008
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d)
OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number 0-19635
GENTA INCORPORATED
(Exact name of Registrant as specified in its charter)
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Delaware
(State or other jurisdiction of
incorporation or organization)
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33-0326866
(I.R.S. Employer
Identification Number) |
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200 Connell Drive |
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Berkeley Heights, NJ
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07922 |
(Address of principal executive offices)
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(Zip Code) |
(908) 286-9800
(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):
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer
þ
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Smaller reporting company
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(Do not check if a smaller reporting company)
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Securities Exchange Act of 1934).
Yes o No þ
As of August 5, 2008, the registrant had 36,760,558 shares of common stock outstanding.
Genta Incorporated
INDEX TO FORM 10-Q
2
GENTA INCORPORATED
CONSOLIDATED BALANCE SHEETS
(In thousands, except par value data)
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June 30, |
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2008 |
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December 31, |
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(unaudited) |
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2007 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
16,278 |
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$ |
5,814 |
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Marketable securities |
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1,999 |
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Accounts
receivable net of allowances of $39 at June 30, 2008
and $38 at December 31, 2007 |
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55 |
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31 |
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Inventory (Note 4) |
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171 |
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225 |
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Prepaid expenses and other current assets (Note 6) |
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18,726 |
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19,170 |
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Total current assets |
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35,230 |
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27,239 |
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Property and equipment, net |
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251 |
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323 |
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Deferred financing costs on convertible note financing (Note 7) |
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1,170 |
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Deferred
financing costs warrant (Note 7) |
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7,378 |
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Other assets |
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1,731 |
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Total assets |
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$ |
44,029 |
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$ |
29,293 |
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LIABILITIES AND STOCKHOLDERS (DEFICIT)/EQUITY |
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Current liabilities: |
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Accounts payable and accrued expenses (Note 6) |
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$ |
30,603 |
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$ |
25,850 |
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Notes payable |
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512 |
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Conversion feature liability (Note 7) |
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740,000 |
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Warrant liability (Note 7) |
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14,800 |
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Total current liabilities |
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785,403 |
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26,362 |
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Long-term
liabilities: |
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Convertible notes due June 9, 2010, issued for $20,000,
net of
beneficial conversion feature of ($19,417) (Note 7) |
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583 |
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Total long-term liabilities |
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583 |
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Commitments and contingencies (Note 12) |
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Stockholders (deficit)/equity (Note 8): |
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Preferred stock, 5,000 shares authorized: |
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Series A convertible preferred stock, $.001 par value;
8 shares issued and outstanding, liquidation value of $385
at June 30, 2008 and December 31, 2007, respectively |
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Series G participating cumulative preferred stock, $.001 par value;
0 shares issued and outstanding at
June 30, 2008
and December 31, 2007, respectively |
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Common stock, $.001 par value; 250,000 shares authorized,
36,741 and 30,621 shares issued and outstanding at June 30, 2008
and December 31, 2007, respectively |
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37 |
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31 |
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Additional paid-in capital |
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444,315 |
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441,159 |
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Accumulated deficit |
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(1,186,309 |
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(438,288 |
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Accumulated other comprehensive income |
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29 |
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Total stockholders (deficit)/equity |
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(741,957 |
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2,931 |
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Total liabilities and stockholders (deficit)/equity |
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$ |
44,029 |
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$ |
29,293 |
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See accompanying notes to consolidated financial statements.
3
GENTA INCORPORATED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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(In thousands, except per share data) |
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2008 |
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2007 |
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2008 |
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2007 |
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Product
sales net |
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$ |
131 |
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$ |
105 |
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$ |
248 |
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$ |
199 |
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Cost of goods sold |
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29 |
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26 |
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54 |
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48 |
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Gross margin |
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102 |
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79 |
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194 |
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151 |
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Operating expenses: |
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Research and development |
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4,454 |
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4,099 |
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10,891 |
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7,481 |
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Selling, general and administrative |
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2,587 |
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4,735 |
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6,225 |
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8,787 |
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Settlement of office lease obligation (Note 5) |
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3,307 |
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3,307 |
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Reduction in liability for settlement of litigation, net (Note 6) |
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(80 |
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(240 |
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(340 |
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(1,800 |
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Total operating expenses |
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10,268 |
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8,594 |
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20,083 |
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14,468 |
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Other income/(expense): |
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Gain on maturity of marketable securities |
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36 |
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31 |
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44 |
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Interest income and other income, net |
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40 |
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269 |
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100 |
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543 |
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Interest expense |
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(198 |
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(25 |
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(223 |
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(109 |
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Amortization of deferred financing costs (Note 7) |
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(840 |
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(840 |
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Fair value
conversion feature liability (Note 7) |
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(720,000 |
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(720,000 |
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Fair value
warrant liability (Note 7) |
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(7,200 |
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(7,200 |
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Total other income/(expense) |
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(728,198 |
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280 |
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(728,132 |
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478 |
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Net loss |
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$ |
(738,364 |
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$ |
(8,235 |
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$ |
(748,021 |
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$ |
(13,839 |
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Net loss per basic and diluted share |
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$ |
(20.10 |
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$ |
(0.27 |
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$ |
(21.21 |
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$ |
(0.48 |
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Shares used in computing net loss per
basic and diluted share |
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36,741 |
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30,621 |
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35,261 |
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28,604 |
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See accompanying notes to consolidated financial statements.
4
GENTA INCORPORATED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
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Six Months Ended June 30, |
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(In thousands) |
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2008 |
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2007 |
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Operating activities: |
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Net loss |
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$ |
(748,021 |
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$ |
(13,839 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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83 |
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93 |
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Amortization of deferred financing costs |
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840 |
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Share-based compensation (Note 9) |
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305 |
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928 |
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Gain on maturity of marketable securities |
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(31 |
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(44 |
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Reduction in liability for settlement of litigation, net (Note 6) |
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(340 |
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(1,800 |
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Change in
fair value conversion feature liability (Note 7) |
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720,000 |
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Change in
fair value warrant liability (Note 7) |
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7,200 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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(24 |
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12 |
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Inventory |
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54 |
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49 |
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Prepaid expenses and other current assets |
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444 |
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558 |
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Accounts payable and accrued expenses |
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5,094 |
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(2,740 |
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Other assets |
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(21 |
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Net cash used in operating activities |
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(14,396 |
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(16,804 |
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Investing activities: |
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Purchase of marketable securities |
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(13,900 |
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Maturities of marketable securities |
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2,000 |
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16,000 |
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Elimination of restricted cash deposits (Note 5) |
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1,731 |
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Purchase of property and equipment |
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(11 |
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(10 |
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Net cash provided by investing activities |
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3,720 |
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2,090 |
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Financing activities: |
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Repayments of note payable |
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(512 |
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(642 |
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Issuance of note payable |
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236 |
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Issuance of convertible notes net of financing cost of $1,205 (Note 7) |
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18,795 |
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Issuance of common stock, net (Note 8) |
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2,857 |
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10,090 |
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Net cash provided by financing activities |
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21,140 |
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9,684 |
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Increase/(decrease) in cash and cash equivalents |
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10,464 |
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(5,030 |
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Cash and cash equivalents at beginning of period |
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5,814 |
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9,554 |
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Cash and cash equivalents at end of period |
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$ |
16,278 |
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$ |
4,524 |
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See accompanying notes to consolidated financial statements.
5
GENTA INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2008
(Unaudited)
1. Reverse Stock Split
At the Annual Meeting of Genta Incorporated (Genta or the Company) on July 11, 2007, the
Companys stockholders authorized its Board of Directors to effect a reverse stock split of all
outstanding shares of common stock, and the Board of Directors subsequently approved the
implementation of a reverse stock split at a ratio of one for six shares, which became effective on
July 13, 2007. All share and per share data in these consolidated financial statements and related
notes hereto have been retroactively adjusted to account for the effect of the reverse stock split
for the three and six month periods ended June 30, 2007, respectively.
2. Organization and Business
Genta is a biopharmaceutical company engaged in pharmaceutical (drug) research and
development, its sole reportable segment. The Company is dedicated to the identification,
development and commercialization of novel drugs for the treatment of cancer and related diseases.
The Company has had recurring annual operating losses since its inception. Management expects
that such losses will continue at least until its lead product, Genasense® (oblimersen
sodium) Injection, receives approval for commercial sale in one or more indications. Achievement of
profitability for the Company is currently dependent on the timing of Genasense®
regulatory approval. Any adverse events with respect to approvals by the U.S. Food and Drug
Administration (''FDA) and/or European Medicines Agency (''EMEA) could negatively impact the
Companys ability to obtain additional funding or identify potential partners.
The Company has prepared its financial statements under the assumption that it is a going
concern. The Companys recurring losses and negative cash flows from operation raise substantial
doubt about its ability to continue as a going concern. The financial statements do not include any
adjustments that might result from the outcome of this uncertainty.
Net cash used in operating activities during the six months ended June 30, 2008 was $14.4
million.
On June 5, 2008, the Company entered into a securities purchase agreement with certain
institutional and accredited investors to place up to $40 million of senior secured convertible
notes with such investors. On June 9, 2008, the Company placed $20 million of such notes in the
initial closing.
The notes bear interest at an annual rate of 15% payable at quarterly intervals in stock or
cash at the Companys option, and are convertible into shares of Genta common stock at a conversion
rate of 100,000 shares of common stock for every $1,000.00 of principal. Holders of the notes have
the right, but not the obligation, for the following 12 months following the initial closing date
to purchase in whole or in part up to an additional $20 million of the notes. The Company shall
have the right to force conversion of the notes in whole or in part if the closing bid price of the
Companys common stock exceeds $0.50 for a period of 20 consecutive trading days. Certain members
of senior management of Genta participated in this offering. The notes are secured by a first lien
on all assets of Genta. The notes include certain events of default, including a requirement that
the Company obtain stockholder approval within a specified period of time to amend its certificate
of incorporation to authorize additional shares of common stock.
6
The Company will require additional cash in order to maximize its commercial opportunities and
continue its clinical development opportunities. The Company has had discussions with other
companies regarding partnerships for the further development and global commercialization of
Genasense®. Additional alternatives available to the Company to subsequently sustain its
operations include financing arrangements with potential corporate partners, debt financing,
asset-based loans, royalty-based financings, equity financing and other sources. However, there can
be no assurance that any such collaborative agreements or other sources of funding will be
available on favorable terms, if at all.
The Company will continue to maintain an appropriate level of spending over the upcoming
fiscal year, given the uncertainties inherent in its business and its current liquidity position.
Presently, with no further financing, management projects that the Company will run out of funds in
the first quarter of 2009. The Company currently does not have any additional financing in place.
There can be no assurance that the Company can obtain financing, if at all, on terms acceptable to
it.
If the Company is unable to raise additional funds, it will need to do one or more of the
following:
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delay, scale back or eliminate some or all of the Companys research and product
development programs and sales and marketing activity; |
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license third parties to develop and commercialize products or technologies that the
Company would otherwise seek to develop and commercialize themselves; |
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attempt to sell the Company; |
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cease operations; or |
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declare bankruptcy. |
3. Summary of Significant Accounting Policies
Basis of Presentation
The consolidated financial statements are presented on the basis of accounting principles
generally accepted in the United States of America. All professional accounting standards that are
effective as of June 30, 2008 have been considered in preparing the consolidated financial
statements. The accompanying consolidated financial statements included herein have been prepared
pursuant to the rules and regulations of the Securities and Exchange Commission. Certain
information and footnote disclosures normally included in financial statements have been condensed
or omitted from this report, as is permitted by such rules and regulations; however, the Company
believes that the disclosures are adequate to make the information presented not misleading. The
preparation of financial statements in conformity with generally accepted accounting principles
requires management to make certain estimates and assumptions that affect reported earnings,
financial position and various disclosures. Actual results could differ from those estimates. The
unaudited consolidated financial statements and related disclosures have been prepared with the
presumption that users of the interim financial information have read or have access to the audited
financial statements for the preceding fiscal year. Accordingly, these financial statements should
be read in conjunction with the audited consolidated financial statements and the related notes
thereto included in the Companys Annual Report on Form 10-K for the fiscal year ended December 31,
2007. Results for interim periods are not necessarily indicative of results for the full year. The
Company has experienced significant quarterly fluctuations in operating results and it expects
those fluctuations will continue.
7
Revenue Recognition
Genta recognizes revenue from product sales when title to product and associated risk of loss
has passed to the customer and the Company is reasonably assured of collecting payment for the
sale. All revenue from product sales are recorded net of applicable allowances for returns, rebates
and other applicable discounts and allowances. The Company allows return of its product for up to
twelve months after product expiration.
Research and Development
Research and development costs are expensed as incurred, including raw material costs required
to manufacture products for clinical trials.
Cash, Cash Equivalents and Marketable Securities
The carrying amounts of cash, cash equivalents and marketable securities approximate fair
value due to the short-term nature of these instruments. Marketable securities primarily consist of
government securities, all of which are classified as available-for-sale. Management determines the
appropriate classification of securities at the time of purchase and reassesses the classification
at each reporting date.
Income Taxes
The Company uses the liability method of accounting for income taxes. Deferred income taxes
are determined based on the estimated future tax effects of differences between the financial
statement and tax bases of assets and liabilities given the provisions of the enacted tax laws.
Management records valuation allowances against net deferred tax assets, if based upon the
available evidence, it is more likely than not that some or all of the deferred tax assets will not
be realized. The Company generated additional net operating losses during the three and six months
ended June 30, 2008 and continues to maintain a full valuation allowance against its net deferred
tax assets.
The Companys Federal tax returns have never been audited. In January 2006, the State of New
Jersey concluded its fieldwork with respect to a tax audit for the years 2000 through 2004. The
State of New Jersey took the position that amounts reimbursed to Genta by Aventis Pharmaceutical
Inc. for co-development expenditures during the audit period were subject to Alternative Minimum
Assessment (AMA), resulting in a liability at that time of approximately $533 thousand. Although
the Company and its outside tax advisors believe the States position on the AMA liability is
unjustified, there is little case law on the matter and it is probable that the Company will be
required to ultimately pay the liability. In March 2007, the Company received a formal assessment
from the State of New Jersey for $712 thousand. As of June 30, 2008, the Company had accrued a tax
liability of $533 thousand, penalties of $27 thousand and interest of $250 thousand related to this
assessment. The Company appealed this decision to the State and on February 13, 2008, the State
notified the Company that its appeal had not been granted. On April 25, 2008, the Company filed a
complaint with the Tax Court of the State of New Jersey to appeal the assessment. A preliminary
pretrial conference has been scheduled with an assigned judge for October 30, 2008. If the matter
is not settled beforehand, it is anticipated that the trial will commence in the first half of
2009.
The Company recorded $34 thousand and $98 thousand in interest expense related to the State of
New Jersey assessment during the six months ended June 30, 2008 and 2007, respectively.
8
Stock Options
Effective January 1, 2006, Genta adopted the fair value recognition provisions of Statement of
Financial Accounting Standards No. 123 (revised 2004), Share-Based Payment, (''SFAS 123R), using
the modified prospective transition method. Under the standard, all share-based payments, including
grants of employee stock options, are recognized in the Consolidated Statement of Operations based
on their fair values. The amount of compensation cost is measured based on the grant-date fair
value of the equity instrument issued. The Company utilizes a Black-Scholes option-pricing model to
measure the fair value of stock options granted to employees. See Note 7 and Note 8 to the
Consolidated Financial Statements for a further discussion on share-based compensation.
Deferred Financing Costs
Deferred financing costs recorded in connection with the issuance of convertible notes,
including for a financing fee and for the issuance of a warrant to the Companys private placement
agent will be amortized over the two-year term of the convertible notes.
Net Loss Per Common Share
Net loss per common share for the three and six months ended June 30, 2008 and 2007,
respectively, are based on the weighted average number of shares of common stock outstanding during
the periods. Basic and diluted loss per share are identical for all periods presented as
potentially dilutive securities have been excluded from the calculation of the diluted net loss per
common share because the inclusion of such securities would be antidilutive. The potentially
dilutive securities include 42.3 million and 2.1 million shares on June 30, 2008 and 2007,
respectively, reserved for the conversion of convertible preferred stock and the exercise of
outstanding options and warrants. In addition, the Convertible Notes are convertible into 2.0
billion shares of common stock, subject to stockholders approval of an increase in the number of
the Companys authorized shares.
Recent Accounting Pronouncements
In December 2007, the Financial Accounting Standards Board (FASB) issued SFAS 141(R),
"Business Combinations (SFAS 141(R)), which replaces SFAS 141. SFAS 141(R) establishes
principles and requirements for how an acquirer in a business combination recognizes and measures
in its financial statements the identifiable assets acquired, the liabilities assumed, and any
controlling interest; recognizes and measures the goodwill acquired in the business combination or
a gain from a bargain purchase; and determines what information to disclose to enable users of the
financial statements to evaluate the nature and financial effects of the business combination. SFAS
141(R) is to be applied prospectively to business combinations for which the acquisition date is on
or after an entitys fiscal year that begins after December 15, 2008. The Company will assess the
impact of SFAS 141(R) if and when a future acquisition occurs.
In December 2007, the FASB issued SFAS 160, Noncontrolling Interests in Consolidated
Financial Statements an amendment of ARB No. 51 (SFAS 160). SFAS 160 establishes new
accounting and reporting standards for the noncontrolling interest in a subsidiary and for the
deconsolidation of a subsidiary. Specifically, this statement requires the recognition of a
noncontrolling interest (minority interest) as equity in the consolidated financial statements and
separate from the parents equity. The amount of net income attributable to the noncontrolling
interest will be included in consolidated net income on the face of the income statement. SFAS 160
clarifies that changes in a parents ownership interest in a subsidiary that do not result in
deconsolidation are equity transactions if the parent retains its controlling financial interest.
In addition, this statement requires that a parent recognize a gain or loss in net income when a
subsidiary is deconsolidated. SFAS 160 also includes expanded disclosure requirements regarding the
interests of the parent and its noncontrolling interest. SFAS 160 is effective for fiscal years,
and interim periods within those fiscal years, beginning on or after December 15, 2008. The Company
does not expect that adoption of this standard will have a material impact on its financial
statements.
9
In December 2007, the Securities and Exchange Commission (SEC) issued Staff Accounting
Bulletin 110 (SAB 110), which permits entities, under certain circumstances, to continue to use
the simplified method of estimating the expected term of plain options as discussed in SAB No.
107 and in accordance with SFAS 123R. The guidance in this release is effective January 1, 2008.
The impact of this standard on the consolidated financial statements did not have a material
effect.
In December 2007, the FASB issued EITF Issue No. 07-1, Accounting for Collaborative
Arrangements, which is effective for calendar year companies on January 1, 2009. The Task Force
clarified the manner in which costs, revenues and sharing payments made to, or received by, a
partner in a collaborative arrangement should be presented in the income statement and set forth
certain disclosures that should be required in the partners financial statements. The Company is
currently assessing the potential impacts of implementing this standard.
In June 2007, the FASB issued EITF Issue No. 07-3, Accounting for Nonrefundable Advance
Payments for Goods or Services Received for Use in Future Research and Development Activities,
which is effective for calendar year companies on January 1, 2008. The Task Force concluded that
nonrefundable advance payments for goods or services that will be used or rendered for future
research and development activities should be deferred and capitalized. Such amounts should be
recognized as an expense as the related goods are delivered or the services are performed, or when
the goods or services are no longer expected to be provided. The impact of this standard on the
consolidated financial statements did not have a material effect.
In February 2007, the FASB issued SFAS 159, The Fair Value Option for Financial Assets and
Financial Liabilities (SFAS 159). SFAS 159 permits all entities to choose to elect, at specified
election dates, to measure eligible financial instruments at fair value. An entity shall report
unrealized gains and losses on items for which the fair value option has been elected in earnings
at each subsequent reporting date and recognize upfront costs and fees related to those items in
earnings as incurred and not deferred. SFAS 159 applies to fiscal years beginning after November
15, 2007, with early adoption permitted for an entity that has also elected to apply the provisions
of SFAS 157, Fair Value Measurements. The impact of this standard on the consolidated financial
statements did not have a material effect.
In September 2006, the FASB issued SFAS 157, Fair Value Measurements. SFAS 157 defines fair
value, establishes a framework for measuring fair value in accordance with accounting principles
generally accepted in the United States of America and expands disclosures about fair value
measurements. SFAS 157 applies under other accounting pronouncements that require or permit fair
value measurements. Accordingly, this pronouncement does not require any new fair value
measurements. The Company was required to adopt SFAS 157 beginning January 1, 2008. The impact of
this standard on the consolidated financial statements did not have a material effect.
4. Inventory
Inventories are stated at the lower of cost or market with cost being determined using the
first-in, first-out (FIFO) method. Inventories consisted of the following ($ thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Raw materials |
|
$ |
24 |
|
|
$ |
24 |
|
Finished goods |
|
|
147 |
|
|
|
201 |
|
|
|
|
|
|
|
|
|
|
$ |
171 |
|
|
$ |
225 |
|
|
|
|
|
|
|
|
The Company has substantial quantities of Genasense® drug supply which are recorded
at zero cost. Such inventory would be available for the commercial launch of this product, should
Genasense® be approved.
10
5. Settlement of Office Lease Obligation
In May 2008, the Company entered into an amendment of its Lease Agreement with The Connell
Company, (Connell), whereby the lease for one floor of office space in Berkeley Heights, New Jersey
was terminated. Connell received a termination payment of $1.3 million, comprised of the Companys
security deposits and will receive a future payment from the Company of $2.0 million upon the
earlier of July 1, 2009 or the receipt of at least $5.0 million in upfront cash from a business
development deal.
6. Reduction in Liability for Legal Settlement
The Company reached an agreement to settle a class action litigation in consideration for
issuance of 2.0 million shares of common stock of the Company (adjusted for any subsequent event
that results in a change in the number of shares outstanding as of January 31, 2007) and $18.0
million in cash for the benefit of plaintiffs and the stockholder class, (see Note 10 to the
Consolidated Financial Statements). The cash portion of the proposed settlement will be covered by
the Companys insurance carriers. Effective June 25, 2007, the Company and plaintiffs executed a
written Stipulation and Agreement of Settlement, which was filed with the Court on August 13, 2007,
seeking preliminary approval. The unopposed Motion for Preliminary Approval of Settlement was
granted on October 30, 2007, and the Court held a hearing on plaintiffs unopposed motion for final
approval of the settlement on March 3, 2008. An order approving the settlement was issued on May
27, 2008 and the settlement became final on June 27, 2008. The Company has also entered into
release and settlement agreements with its insurance carriers, pursuant to which insurance will
cover the settlement fee and various costs incurred in connection with the action. Under FASB
Statement No. 5, Accounting for Contingencies and FASB Interpretation No. 14, Reasonable
Estimation of the Amount of a Loss, an interpretation of FASB Statement No. 5, the Company
recorded an expense of $5.3 million, comprised of 2.0 million shares of the Companys common stock
valued at a market price of $2.64 on December 31, 2006. At December 31, 2007, the revised estimated
value of the common shares portion of the litigation settlement was $1.0 million, based on a
closing price of Gentas common stock of $0.52 per share. At June 27, 2008, the date that the
settlement became final, the revised value of the common stock portion of the litigation settlement
was $0.7 million, based on a closing price of Gentas common stock of $0.35 per share, resulting in
a reduction in the provision of $0.3 million for the six months ended June 30, 2008. The liability
for the settlement of litigation, originally recorded at $23.2 million at December 31, 2006, is
measured at $18.7 million at June 30, 2008 and is included in accounts payable and accrued expenses
in the Companys Consolidated Balance Sheets. An insurance receivable of $18.0 million is included
in prepaid expenses and other current assets in the Companys Consolidated Balance Sheets.
7. Convertible Notes and Warrant
On June 5, 2008, the Company entered into a securities purchase agreement with certain
institutional and accredited investors to place up to $40.0 million of senior secured convertible
notes with such investors. On June 9, 2008, the Company placed $20.0 million of such notes in the
initial closing. The notes bear interest at an annual rate of 15% payable at quarterly intervals in
stock or cash at the Companys option, and are convertible into shares of Genta common stock at a
conversion rate of 100,000 shares of common stock for every $1,000.00 of principal. The notes
include certain events of default, including a requirement that the Company obtain stockholder
approval within a specified period of time to amend its certificate of incorporation to authorize
additional shares of common stock. In addition, the notes prohibit any additional financing without
the approval of holders of more than two-thirds of the principal amount of the notes.
Upon the occurrence of an event of default, holders of the notes have the right to require the
Company to prepay all or a portion of their notes as calculated as the greater of (a) 150% of the
aggregate principal amount of the note plus accrued interest or (b) the aggregate principal amount
of the note plus accrued interest divided by the conversion price; multiplied by a weighted average
price of the Companys common stock. Pursuant to a general security agreement, entered into
concurrent with the notes, (the Security Agreement), the notes are secured by a first lien on all
assets of the Company, subject to certain exceptions set forth in the Security Agreement.
11
In addition, in connection with the placement of the senior secured convertible notes, the
Company issued a warrant to its private placement agent to purchase 40,000,000 shares of common
stock at an exercise price of $0.02 per share and incurred a financing fee of $1.2 million. The
deferred financing costs including for a financing fee and for the issuance of the warrant will be
amortized over the two-year term of the convertible notes.
The Company concluded that it should initially account for conversion options embedded in
convertible notes in accordance with SFAS No. 133 Accounting for Derivative Instruments and
Hedging Activities (SFAS 133) and EITF 00-19 Accounting for Derivative Financial Instruments
Indexed to, and Potentially Settled in, a Companys Own Stock (EITF 00-19). SFAS 133 generally
requires companies to bifurcate conversion options embedded in convertible notes from their host
instruments and to account for them as free standing derivative financial instruments in accordance
with EITF 00-19. EITF 00-19 states that if the conversion option requires net cash settlement in
the event of circumstances that are not solely within the Companys control, that the notes should
be classified as a liability measured at fair value on the balance sheet. In this case, if the
Company is not successful in obtaining approval of its stockholders to increase the number of
authorized shares to accommodate the potential number of shares that the notes convert into, the
Company will be required to cash settle the conversion option.
Upon the issuance date, there were an insufficient number of authorized shares of common stock
in order to permit exercise of all of the issued convertible notes. In accordance with EITF 00-19,
when there are insufficient authorized shares, the conversion obligation for the notes should be
classified as a liability measured at fair value on the balance sheet. Accordingly, at June 9,
2008, in connection with the $20.0 million initial closing, the convertible features of the notes
were recorded as derivative liabilities of $380.0 million.
At the recording of the initial closing, the fair value of the conversion feature, $380.0
million, exceeded the proceeds of $20.0 million. The difference of $360.0 million was charged to
expense as the change in the fair market value of conversion liability. Accordingly, the Company
recorded an initial discount of $20.0 million equal to the face value of the notes, which will be
amortized over the two-year term, using the effective-interest method.
At June 30, 2008, the Company accounted for the conversion options using the fair value
method, with the resultant loss recognition recorded against earnings. At June 30, 2008, the fair
value of the conversion feature liability was $740.0 million, comprised of the $380.0 million
recorded at the initial closing and $360.0 million recorded to mark the liability to market at June
30. The conversion option was valued at June 9, 2008 and June 30, 2008 using the Black-Scholes
valuation model using the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
June 30, 2008 |
|
June 9, 2008 |
Volatility |
|
|
127.7 |
% |
|
|
125.6 |
% |
Risk-free interest rate |
|
|
2.63 |
% |
|
|
2.73 |
% |
Remaining contractual lives |
|
|
1.94 |
|
|
|
2.00 |
|
The conversion feature liability will be accounted for using mark-to-market accounting at each
reporting date until all the criteria for permanent equity have been met.
As there were an insufficient number of authorized shares of common stock in order to fulfill
all existing obligations, as required by EITF 00-19, the Company classified the warrant obligation
as a liability to be measured at fair value on the balance sheet. Accordingly, at June 9, 2008, the
Company recorded the warrant liabilities at a fair value of $7.6 million based upon the
Black-Scholes valuation model. The warrant liabilities will be accounted for using mark-to-market
accounting and charged to expense in a manner similar to the conversion feature at each reporting
date until all the criteria for permanent equity have been met.
12
At June 30, 2008 the Company accounted for the warrant liabilities using the fair value
method, with the resultant loss recognition recorded against earnings. At June 30, 2008, the fair
value of the warrant liability was $14.8 million, comprised of the $7.6 million recorded at the
initial closing and $7.2 million recorded to mark the liability to market at June 30, 2008. The
warrant liability was valued at June 9, 2008 and June 30, 2008 using the Black-Scholes valuation
model using the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
June 30, 2008 |
|
June 9, 2008 |
Volatility |
|
|
115.5 |
% |
|
|
115.0 |
% |
Risk-free interest rate |
|
|
3.34 |
% |
|
|
3.41 |
% |
Remaining contractual lives |
|
|
4.94 |
|
|
|
5.00 |
|
The Company is planning to have an Annual Meeting of Stockholders later this year and its
Board of Directors has recommended that stockholders approve a charter amendment to increase the
amount of the Companys authorized shares. Once stockholders approve an increase in the amount of
authorized shares, the marked-to-market liabilities for the
conversion feature and the warrant will
be transferred to Stockholders Equity.
8. Stockholders Equity
Common Stock
On February 13, 2008, the Company sold 6.1 million shares of the Companys common stock at a
price of $0.50 per share, raising approximately $3.1 million, before estimated fees and expenses of
approximately $203 thousand.
Series A Preferred Stock
Each share of Series A Preferred Stock is immediately convertible into shares of the Companys
common stock, at a rate determined by dividing the aggregate liquidation preference of the Series A
Preferred Stock by the conversion price. The conversion price is subject to adjustment for
antidilution. As of June 30, 2008 and December 31, 2007, each share of Series A Preferred Stock was
convertible into 153.4393 and 2.3469 shares of common stock, respectively. At June 30, 2008 and
December 31, 2007, the Company had 7,700 shares of Series A Convertible Preferred Stock issued and
outstanding.
Warrant
In connection with the June 2008 convertible note financing, the Company issued a common stock
purchase warrant to its private placement agent. The warrant is exercisable into 40,000,000 shares
of common stock at an exercise price of $0.02 per share.
9. Share-Based Compensation
The Company estimates the fair value of each option award on the date of the grant using the
Black-Scholes option valuation model. Expected volatilities are based on the historical volatility
of the Companys common stock over a period commensurate with the options expected term. The
expected term represents the period of time that options granted are expected to be outstanding and
is calculated in accordance with the Securities and Exchange Commission (SEC) guidance provided
in the SECs Staff Accounting Bulletin 107, (SAB 107) and Staff Accounting Bulletin 110 (SAB
110), using a simplified method. The Company will continue to use the simplified method as it
does not have sufficient historical exercise data to provide a reasonable basis upon which to
estimate an expected term. The risk-free interest rate assumption is based upon observed interest
rates appropriate for the expected term of the Companys stock options. There were no grants of
stock options during the six months ended June 30, 2008. The following table summarizes the
weighted-average assumptions used in the Black-Scholes model for options granted during the six
months ended June 30, 2007:
13
|
|
|
|
|
|
|
Six Months Ended |
|
|
June 30, 2007 |
Expected volatility |
|
|
102 |
% |
Expected dividends |
|
|
|
|
Expected term (in years) |
|
|
6.25 |
|
Risk-free rate |
|
|
4.6 |
% |
Share-based compensation expense recognized for the three and six months ended June 30, 2008
and 2007, respectively, was comprised as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30 |
|
|
June 30 |
|
($ thousands, except per share data) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Research and development expenses |
|
$ |
52 |
|
|
$ |
144 |
|
|
$ |
96 |
|
|
$ |
351 |
|
Selling, general and administrative |
|
|
108 |
|
|
|
214 |
|
|
|
209 |
|
|
|
577 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total share-based compensation expense |
|
$ |
160 |
|
|
$ |
358 |
|
|
$ |
305 |
|
|
$ |
928 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense, per
basic and diluted common share |
|
$ |
0.00 |
|
|
$ |
0.01 |
|
|
$ |
0.01 |
|
|
$ |
0.03 |
|
10. Stock Option Plans
As of June 30, 2008, the Company has three share-based compensation plans, which are described
below:
2007 Stock Incentive Plan
On September 17, 2007, the Companys Board of Directors approved the Companys 2007 Stock
Incentive Plan (the 2007 Plan), pursuant to which 8.5 million shares of the Companys common
stock will be authorized for issuance, subject to approval of the Companys stockholders. Awards
may be made under the plan to officers, employees, directors and consultants in the form of
incentive stock options, non-qualified stock options, stock appreciation rights, dividend
equivalent rights, restricted stock, restricted stock units and other stock-based awards. Awards
granted under the plan prior to stockholder approval of the plan are subject to and conditioned
upon receipt of such approval on or before September 17, 2008. Should such stockholder approval
not be obtained on or before such date, the plan will terminate and any awards granted pursuant to
the plan will terminate and cease to be outstanding.
On September 17, 2007 and September 20, 2007, the Board of Directors approved the issuance of
a combined total of 5.4 million options under the 2007 Plan. As of June 30, 2008, there are 4.2
million options outstanding under the 2007 Plan. Most of these awards vest over a three-year period
in increments of 50%, 25% and 25%, beginning on the first anniversary of the date of the grant. The
Company has not recognized compensation expense for these grants, because a grant date as defined
in SFAS 123R has not occurred. This is because the grant of these options is contingent upon
stockholder approval, which cannot be assured.
Acquisition Bonus Program
On September 17, 2007, the Board of Directors approved an Acquisition Bonus Program. Under the
program, participants are eligible to share in a portion of the proceeds realized from a change in
control of the Company that occurs prior to the earlier of (i) December 31, 2008 or (ii) the
approval by the Companys stockholders of the 2007 Stock Incentive Plan.
14
Pursuant to the program, participants selected by the Board of Directors will be awarded a
number of units with a designated base value. The amount of a participants bonus award will be
determined by multiplying (i) the difference between the unit value and the base value by (ii) the
number of units awarded to such participant. The unit value for each unit will be determined by
dividing the change in control proceeds (as defined in the award agreement) by the total number of
shares of the Companys common stock outstanding at the time of the change in control. The units
will be subject to a vesting schedule, if any, determined by the Board of Directors at the time the
unit award is made. Bonus awards will generally be paid in cash within 30 days after the later of
(i) the effective date of the change in control or (ii) the date the change in control proceeds are
paid to the Companys stockholders. The maximum number of units that may be awarded under the
Acquisition Bonus Program is 8.5 million units, which equals the number of shares of the Companys
common stock that are authorized for issuance under the 2007 Plan. On September 27, 2007, 5.4
million acquisition bonus units were granted under the Acquisition Bonus Program, and as of June
30, 2008, 4.2 million acquisition bonus units are outstanding.
Any stock options granted to a participant under the 2007 Plan will terminate and cease to be
outstanding in the event the participant becomes entitled to receive a payment under the
Acquisition Bonus Program.
1998 Stock Incentive Plan
Pursuant to the Companys 1998 Stock Incentive Plan, as amended, (the 1998 Plan), 3.4
million shares have been provided for the grant of stock options to employees, directors,
consultants and advisors of the Company. Option awards must be granted with an exercise price at
not less than the fair market price of the Companys common stock on the date of the grant; those
option awards generally vest over a four-year period in equal increments of 25%, beginning on the
first anniversary of the date of the grant. All options granted have contractual terms of ten years
from the date of the grant. As of May 27, 2008, the authorization to provide grants under the 1998
Plan expired.
The following table summarizes the option activity under the 1998 Plan as of June 30, 2008 and
changes during the six months then ended:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
Aggregate |
|
|
|
|
|
|
Weighted |
|
Remaining |
|
Intrinsic |
|
|
Number of |
|
Average |
|
Contractual |
|
Value |
|
|
Shares |
|
Exercise |
|
Term |
|
(in |
|
|
(in thousands) |
|
Price |
|
(in years) |
|
thousands) |
Stock Options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at January 1, 2008 |
|
|
2,155 |
|
|
$ |
23.05 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
(137 |
) |
|
|
6.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2008 |
|
|
2,018 |
|
|
$ |
24.21 |
|
|
|
4.4 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and exercisable at June 30, 2008 |
|
|
1,371 |
|
|
$ |
23.79 |
|
|
|
2.1 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
There is no intrinsic value to outstanding stock options as the exercise prices of all
outstanding options are above the market price of the Companys stock at June 30, 2008. The amount
of aggregate intrinsic value will change based on the market value of the Companys stock.
As of June 30, 2008, there was approximately $0.5 million of total unrecognized compensation
cost related to non-vested share-based compensation granted resulting from stock options granted
under the 1998 Plan, which is expected to be recognized over a weighted-average period of 1.1
years.
15
The following table summarizes the restricted stock unit (RSU) activity under the 1998 Plan as
of June 30, 2008 and changes during the six months then ended:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Number of Shares |
|
Grant Date Fair |
|
|
(in thousands) |
|
Value per Share |
Restricted Stock Units |
|
|
|
|
|
|
|
|
Outstanding nonvested RSUs at January 1, 2008 |
|
|
20 |
|
|
$ |
1.42 |
|
Granted |
|
|
488 |
|
|
$ |
0.41 |
|
Forfeited or expired |
|
|
(195 |
) |
|
$ |
0.41 |
|
|
|
|
|
|
|
|
|
|
Outstanding nonvested RSUs at June 30, 2008 |
|
|
313 |
|
|
$ |
0.47 |
|
As of June 30, 2008, there was approximately $56 thousand of total unrecognized compensation
cost related to non-vested share-based compensation resulting from RSUs granted under the 1998
Plan, which is expected to be recognized over the next twelve months.
1998 Non-Employee Directors Plan
Pursuant to the Companys 1998 Non-Employee Directors Plan as amended (the Directors
Plan), 0.6 million shares have been provided for the grant of non-qualified stock options to the
Companys non-employee members of the Board of Directors. Option awards must be granted with an
exercise price at not less than the fair market price of the Companys common stock on the date of
the grant. Initial option grants vest over a three-year period in equal increments, beginning on
the first anniversary of the date of the grant. Subsequent grants, generally vest on the date of
the grant. All options granted have contractual terms of ten years from the date of the grant.
The fair value of each option award is estimated on the date using the same valuation model
used for options granted under the 1998 Plan.
The following table summarizes the option activity under the Directors Plan as of June 30,
2008 and changes during the six months then ended:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
Aggregate |
|
|
Number of |
|
Weighted |
|
Remaining |
|
Intrinsic |
|
|
Shares |
|
Average |
|
Contractual |
|
Value |
|
|
(in |
|
Exercise |
|
Term |
|
(in |
|
|
thousands) |
|
Price |
|
(in years) |
|
thousands) |
Stock Options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at January 1, 2008 |
|
|
113 |
|
|
$ |
30.61 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
(1 |
) |
|
|
39.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June, 2008 |
|
|
112 |
|
|
$ |
30.49 |
|
|
|
5.9 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and exercisable at June 30, 2008 |
|
|
111 |
|
|
$ |
31.06 |
|
|
|
5.9 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
There is no intrinsic value to outstanding stock options as the exercise prices of all
outstanding options are above the market price of the Companys stock at June 30, 2008. The amount
of aggregate intrinsic value will change based on the market value of the Companys stock.
16
An analysis of comprehensive loss is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
($ in thousands) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Net loss |
|
$ |
(738,364 |
) |
|
$ |
(8,235 |
) |
|
$ |
(748,021 |
) |
|
$ |
(13,839 |
) |
Change in market value
of available-for-sale
marketable securities |
|
|
|
|
|
|
(10 |
) |
|
|
|
|
|
|
(36 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
$ |
(738,364 |
) |
|
$ |
(8,225 |
) |
|
$ |
(748,021 |
) |
|
$ |
(13,803 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
12. Commitments and Contingencies
Litigation and Potential Claims
In 2004, numerous complaints were filed in the United States District Court for the District
of New Jersey, or the Court, against Genta and certain of its principal officers on behalf of
purported classes of the Companys stockholders who purchased its securities during several class
periods. The complaints were consolidated into a single action and alleged that the Company and
certain of its principal officers violated the federal securities laws by issuing materially false
and misleading statements regarding Genasense® for the treatment of malignant melanoma that had the
effect of artificially inflating the market price of the Companys securities. The stockholder
class action complaint sought monetary damages in an unspecified amount and recovery of plaintiffs
costs and attorneys fees. The Company reached an agreement with plaintiffs to settle the class
action litigation in consideration for the issuance of 2.0 million shares of common stock of the
Company (adjusted for any subsequent event that results in a change in the number of shares
outstanding as of January 31, 2007) and $18.0 million in cash for the benefit of plaintiffs and the
stockholder class. The cash portion of the proposed settlement will be covered by the Companys
insurance carriers. Effective June 25, 2007, the Company and plaintiffs executed a written
Stipulation and Agreement of Settlement which was filed with the Court on August 13, 2007, seeking
preliminary approval. The unopposed Motion for Preliminary Approval of Settlement was granted on
October 30, 2007, and the Court held a hearing on plaintiffs unopposed motion for final approval
of the settlement on March 3, 2008. An order approving the settlement was issued on May 27, 2008
and the settlement became final on June 27, 2008. See Note 6 to the Consolidated Financial
Statements for a discussion on the accounting for the liability for the legal settlement.
The settlement did not constitute an admission of guilt or liability.
In February 2007, a complaint against the Company was filed in the Superior Court of New
Jersey by Howard H. Fingert, M.D., a former employee of the Company. The complaint alleges, among
other things, breach of contract as to the Companys stock option plan and as to a consulting
agreement allegedly entered into by the Company and Dr. Fingert subsequent to termination of Dr.
Fingerts employment with the Company, breach of implied covenant of good faith and fair dealing
with respect to the Companys stock option plan and the alleged consulting agreement, promissory
estoppel with respect to the exercise of stock options and provision of consulting services after
termination of employment, and fraud and negligent misrepresentation with respect to the exercise
of stock options and provision of consulting services after termination of employment. The
complaint seeks monetary damages, including punitive and consequential damages. The Company filed
an answer to the complaint on May 29, 2007, and on August 8, 2007, filed a request for production
of documents. On January 4, 2008, the Court dismissed the complaint without prejudice due to Dr.
Fingerts failure to produce the requested discovery. Dr. Fingert filed a motion dated March 24,
2008 to reinstate the complaint, which was granted by the Court on April 11, 2008 at which time the
Court adopted a discovery schedule that concludes in December 2008. The Company denies the
allegations in the complaint and intends to vigorously defend this lawsuit.
17
In November 2007, a complaint against the Company was filed in the United States District
Court for the District of New Jersey by Ridge Clearing & Outsourcing Solutions, Inc. The complaint
alleges, among other things, that the Company caused or contributed to losses suffered by a Company
stockholder, which have been incurred by Ridge. The Company filed its Answer and Affirmative
Defenses on February 27, 2008 to respond to the complaint. The Company denies the allegations in
the complaint and intends to vigorously defend this lawsuit.
13. Supplemental Disclosure of Cash Flows Information and Non-cash Investing and Financing
Activities
No interest or income taxes were paid for the six months ended June 30, 2008, and
2007,
respectively.
14. Listing of Common Stock of Genta Incorporated
Effective May 7, 2008, the
trading of common stock of Genta Incorporated was moved from The
NASDAQ Capital Markets to the Over-the-Counter Bulletin Board (OTCBB) maintained by FINRA
(formerly, the NASD). This action was taken pursuant to receipt of notification from the NASDAQ
Listing Qualifications Panel that the Company had failed to demonstrate its ability to sustain
compliance with the $2.5 million minimum stockholders equity requirement for continued listing on
The NASDAQ Capital Markets. On July 10, 2008, the Company received notification from The NASDAQ Capital
Market that The NASDAQ Capital Market had determined to remove the Companys common stock from listing on
such exchange. The delisting was effective at the opening of the trading session on July 21, 2008.
18
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Certain Factors Affecting Forward-Looking Statements Safe Harbor Statement
The statements contained in this Quarterly Report on Form 10-Q that are not historical are
forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements
regarding the expectations, beliefs, intentions or strategies regarding the future. We intend that
all forward-looking statements be subject to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements reflect our views as of the date
they are made with respect to future events and financial performance, but are subject to many
risks and uncertainties, which could cause actual results to differ materially from any future
results expressed or implied by such forward-looking statements. Forward-looking statements
include, without limitation, statements about:
|
|
|
the Companys financial projections; |
|
|
|
|
the Companys projected cash flow requirements and estimated timing of sufficient cash
flow; |
|
|
|
|
the Companys current and future license agreements, collaboration agreements, and
other strategic alliances; |
|
|
|
|
the Companys ability to obtain necessary regulatory approval for Genasense®
(oblimersen sodium) Injection from the U.S. Food and Drug Administration (FDA) or
European Medicines Agency (EMEA); |
|
|
|
|
the safety and efficacy of the Companys products; |
|
|
|
|
the commencement and completion of clinical trials; |
|
|
|
|
the Companys ability to develop, manufacture, license and sell its products or product
candidates; |
|
|
|
|
the Companys ability to enter into and successfully execute license and collaborative
agreements, if any; |
|
|
|
|
the adequacy of the Companys capital resources and cash flow projections, and the
Companys ability to obtain sufficient financing to maintain the Companys planned
operations; or the Companys risk of bankruptcy if it is unsuccessful in obtaining such
financing or in securing stockholder approval to increase the number of shares authorized
for issuance under the Companys certificate of incorporation, as required by the
transactional documents in our recent financing; |
|
|
|
|
the adequacy of the Companys patents and proprietary rights; |
|
|
|
|
the impact of litigation that has been brought against the Company and its officers and
directors and any proposed settlement of such litigation; and |
|
|
|
|
the other risks described under Risk Factors in the Companys Annual Report on Form
10-K for the fiscal year ended December 31, 2007 and in this Form 10-Q. |
We do not undertake to update any forward-looking statements.
We make available free of charge on our Internet website (http://www.genta.com) our Annual
Report on Form 10-K, Quarterly Reports on Form 10-Q, current reports on Form 8-K and amendments to
these reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act
of 1934 as soon as reasonably practicable after we electronically file such material with, or
furnish it to, the Securities and Exchange Commission. The content on the Companys website is
available for informational purposes only. It should not be relied upon for investment purposes,
nor is it incorporated by reference into this Form 10-Q.
19
Overview
Genta Incorporated is a biopharmaceutical company engaged in pharmaceutical research and
development. We are dedicated to the identification, development and commercialization of novel
drugs for the treatment of cancer and related diseases. Our drug portfolio consists of products
derived in two Programs: DNA/RNA Medicines (which includes our lead oncology drug,
Genasense®); and Small Molecules (which includes our marketed product,
Ganite®, and the investigational compounds tesetaxel and G4544). We have had recurring
annual operating losses since inception and we expect to incur substantial operating losses due to
continued requirements for ongoing and planned research and development activities, pre-clinical
and clinical testing, manufacturing activities, regulatory activities and the eventual
establishment of a sales and marketing organization. From our inception to June 30, 2008, we have
incurred a cumulative net deficit of $1,186.3 million. Our recurring losses from operations and our
negative cash flow from operations raise substantial doubt about our ability to continue as a going
concern. Our consolidated financial statements do not include any adjustments that might result
from the outcome of this uncertainty. We expect that such losses will continue at least until our
lead product, Genasense®, is approved by one or more regulatory authorities for
commercial sale in one or more indications. Achievement of profitability is currently dependent on
the timing of Genasense® regulatory approvals. We have experienced significant quarterly
fluctuations in operating results and we expect that these fluctuations in revenues, expenses and
losses will continue.
We had $16.3 million of cash, cash equivalents and marketable securities on hand at June 30,
2008. Cash used in operating activities during the first six months of 2008 was $14.4 million.
Irrespective of whether regulatory applications, such as a New Drug Application (NDA) or
Marketing Authorization Application (MAA), for Genasense® are approved, we anticipate
that we will require additional cash in order to maximize the commercial opportunity and continue
its clinical development opportunities. Alternatives available to us to sustain our operations
include collaborative agreements, equity financing, debt and other financing arrangements with
potential corporate partners and other sources. However, there can be no assurance that any such
collaborative agreements or other sources of funds will be available on favorable terms, if at all.
We will need substantial additional funds before we can expect to realize significant product
revenue.
We will continue to maintain an appropriate level of spending over the upcoming fiscal year,
given the uncertainties inherent in our business and our current liquidity position. On June 5,
2008, we entered into a securities purchase agreement with certain institutional and accredited
investors to place up to $40 million of our senior secured convertible notes with such investors.
On June 9, 2008, we placed $20 million of such notes in the initial closing. Presently, with no
further financing, we project that we will run out of funds in the first quarter of 2009. We
currently do not have any additional financing in place. If we are unable to raise additional
funds, we could be required to reduce our spending plans, reduce our workforce, license to others
products or technologies we would otherwise seek to commercialize ourselves, or sell certain
assets. There can be no assurance that we can obtain financing, if at all, on terms acceptable to
us.
Our financial results have been and will continue to be significantly affected by regulatory
actions related to Genasense®.
Genasense® has been studied in combination with a wide variety of anticancer drugs
in a number of different cancer indications. We have reported results from randomized Phase 3
trials of Genasense® in seven different diseases: melanoma; chronic lymphocytic leukemia
(CLL); multiple myeloma; acute myeloid leukemia (AML); non small cell lung cancer; small cell lung
cancer; and prostate cancer. Under our own sponsorship or in collaboration with the U.S. National
Cancer Institute (NCI), we are currently conducting additional clinical trials. We are especially
interested in the development, regulatory approval, and commercialization of Genasense®
in at least three diseases: melanoma; chronic lymphocytic leukemia (CLL); and non-Hodgkins
lymphoma (NHL).
20
Genasense® has been submitted for regulatory approval in the U.S. on two occasions
and to the European Union (EU) once. These applications proposed the use of Genasense®
plus chemotherapy for patients with advanced melanoma (U.S. and EU) and relapsed or refractory
chronic lymphocytic leukemia (U.S.-only). None of these applications were successful. Nonetheless,
the Company believes that Genasense® can ultimately be approved and commercialized for
both of these indications, as well as for other diseases, and we have undertaken a number of
initiatives in this regard that are described below.
The New Drug Application for Genasense® in melanoma was withdrawn in 2004 after an
advisory committee to the Food and Drug Administration (FDA) failed to recommend approval. A
negative decision was also received for a similar application in melanoma from the European
Medicines Agency (EMEA) in 2007. Data from the pivotal Phase 3 trial that comprised the primary
basis for these applications were published in a peer-reviewed journal in 2006. These results
showed that treatment with Genasense® plus dacarbazine compared with dacarbazine alone
in patients with advanced melanoma was associated with a statistically significant increase in
overall response, complete response, durable response, and progression-free survival (PFS).
However, the primary endpoint of overall survival approached but did not quite reach statistical
significance (P=0.077). Subsequently, our analysis of this trial showed that there was a
significant treatment interaction effect related to levels of a blood enzyme known as LDH. When
this effect was analyzed by treatment arm, survival was shown to be significantly superior for
patients with a non-elevated LDH who received Genasense® (P=0.018; n=508). Moreover,
this benefit was particularly noteworthy for patients whose baseline LDH did not exceed 80% of the
upper limit of normal for this lab value.
Based on these data, in August 2007 we initiated a new Phase 3 trial of Genasense®
plus chemotherapy in advanced melanoma. The trial, known as AGENDA, is a randomized, double-blind,
placebo-controlled study in which patients are randomly assigned to receive Genasense®
plus dacarbazine or dacarbazine alone. The study uses LDH as a biomarker to identify patients who
are most likely to respond to Genasense®, based on data obtained from our preceding
trial in melanoma. The co-primary endpoints of AGENDA are progression-free survival and overall
survival.
AGENDA is designed to expand evidence for the safety and efficacy of Genasense®
combined with dacarbazine chemotherapy for patients who have not previously been treated with
chemotherapy. The study prospectively targets patients who have low-normal levels of LDH. We expect
to enroll approximately 300 subjects at approximately 90 sites worldwide in this trial.
Genasense® in melanoma has been designated an Orphan Drug in Australia and the United
States, and the drug has Fast Track designation in the United States. Target accrual of 300
patients is currently projected to complete in the fourth quarter of 2008. Initial data on the
interim assessment of progression-free survival is expected in the first half of 2009. If the
initial assessment of progression-free survival is positive, the Company expects to discuss these
results with the FDA and EMEA and to secure agreement from these agencies that Genta may commence
submission of new regulatory applications for the approval of Genasense® plus
chemotherapy in patients with advanced melanoma. Approval by FDA and EMEA will allow
Genasense® to be commercialized by us in the U.S. and in the European Union.
Given our belief in the activity of Genasense® in melanoma, we have initiated and
expect to initiate additional clinical studies in this disease. One such study is the Phase 2
trial of Genasense® plus a chemotherapy regimen consisting of Abraxane®
(paclitaxel albumen) plus temozolomide (Temodar®). We also expect to examine different
dosing regimens that will improve the dosing convenience and commercial acceptance of
Genasense®, including its administration by brief (1-2 hour) IV infusions.
21
Our initial NDA for the use of Genasense® plus chemotherapy in patients with
relapsed or refractory CLL was also unsuccessful. We conducted a randomized Phase 3 trial in 241
patients with relapsed or refractory CLL who were treated with fludarabine and cyclophosphamide
(Flu/Cy) with or without Genasense®. The trial achieved its primary endpoint:
a statistically significant increase (17% vs. 7%; P=0.025) in the proportion of patients who
achieved a complete response (CR), defined as a complete or nodular partial response. Patients who
achieved this level of response also experienced disappearance of predefined disease symptoms. A
key secondary endpoint, duration of CR, was also significantly longer for patients treated with
Genasense® (median not reached but exceeding 36+ months in the Genasense®
group, versus 22 months in the chemotherapy-only group).
Several secondary endpoints were not improved by the addition of Genasense®. The
percentage of patients who experienced serious adverse events was increased in the
Genasense® arm; however, the percentages of patients who discontinued treatment due to
adverse events were equal in the treatment arms. The incidence of certain serious adverse
reactions, including but not limited to nausea, fever and catheter-related complications, was
increased in patients treated with Genasense®.
In December 2005, we submitted a NDA to the FDA that sought accelerated approval for the use
of Genasense® in combination with Flu/Cy for the treatment of patients with relapsed or
refractory CLL who had previously received fludarabine. In December 2006 we received a
non-approvable notice for that application from FDA. However, since we believed that our
application had met the regulatory requirements for approval, in April 2007 we filed an appeal of
the non-approvable notice using FDAs Formal Dispute Resolution process. In March, 2008, we
received a formal notice from FDA that indicated additional confirmatory evidence would be required
to support approval of Genasense® in CLL. In that communication, FDA recommended two
alternatives for exploring that confirmatory evidence. One option was to conduct an additional
clinical trial. The other option was to collect additional information regarding the clinical
course and progression of disease in patients from the completed trial. We have elected to pursue
both of these options.
For the first option, we submitted a new protocol in the second quarter of 2008 that sought
Special Protocol Assessment (SPA) from the FDA and Scientific Advice from the EMEA. This protocol
is similar in design to the completed trial and uses the same chemotherapy and randomization
scheme. The major difference is that the trial focuses on the patient population who derived
maximal benefit in the completed trial. This group is characterized by patients who had received
less extensive chemotherapy prior to entering the trial and who were defined as being
non-refractory to fludarabine. We have deferred initiation of this trial until we receive a
response to the second option, described below.
For the second option, we sought information regarding long-term survival on patients who had
been accrued to our already completed Phase 3 trial. At a scientific meeting in June 2008, we
announced the results of long-term follow-up from the completed Phase 3 trial that comprised the
original NDA. With 5 years of follow-up, we showed that patients treated with Genasense®
plus chemotherapy who achieved either a complete response (CR) or a partial response (PR) had also
achieved a statistically significant increase in survival.
Previous analyses had shown a significant survival benefit accrued to patients in the
Genasense® group who attained CR. Extended follow-up showed that all major responses
(CR+PR) achieved with Genasense® were associated with significantly increased survival
compared with all major responses achieved with chemotherapy alone (median = 56 months vs. 38
months, respectively). After 5 years of follow-up, 22 of 49 (45%) responders in the
Genasense® group were alive compared with 13 of 54 (24%) responders in the
chemotherapy-only group (hazard
ratio = 0.6; P = 0.038). Moreover, with 5 years of follow-up, 12 of
20 patients (60%) in the Genasense® group who achieved CR were alive, 5 of these
patients remained in continuous CR without relapse, and 2 additional patients had relapsed but had
not required additional therapy. By contrast, only 3 of 8 CR patients in the chemotherapy-only
group were alive, all 3 had relapsed, and all 3 had required additional anti-leukemic treatment.
22
The Company believes that the significant survival benefit associated with major responses to
Genasense® may provide the confirmatory evidence of clinical benefit that was requested
by FDA. The Company submitted these new data to FDA in the second quarter of 2008, and the
submission was accepted as a complete response to the non-approvable decision letter on July 11,
2008. In that notice of acceptance, FDA assigned a user fee goal date of December 3, 2008, meaning
that FDA will respond to the new submission regarding approvability of the CLL NDA on or before
that date. We have elected not to initiate the aforementioned confirmatory trial until FDA has
rendered its decision on the pending NDA.
As with melanoma, Genta believes the clinical activity in CLL should be explored with
additional clinical research. The Company plans to explore combinations of Genasense with other
drugs that are used for the treatment of CLL, and to examine more convenient dosing regimens.
Lastly, several trials have shown definite evidence of clinical activity for
Genasense® in patients with non-Hodgkins lymphoma (NHL). We would like to conduct
additional clinical studies in patients with NHL to test whether Genasense® can be
approved in this indication. Previously, we reported that randomized trials of
Genasense® in patients with myeloma, acute myeloid leukemia, (AML), hormone-refractory
prostate cancer (HRPC), small cell lung cancer and non small cell lung cancer were not sufficiently
positive to warrant further investigation on the dose-schedules that were examined or with the
chemotherapy that was employed in these trials. Data from these trials have been presented at
various scientific meetings. However, we believe that alternate dosing schedules, in particular
the use of brief high-dose infusions, offer the opportunity to re-examine the drugs activity in
some of these indications, in particular multiple myeloma.
On March 7, 2008, we obtained an exclusive worldwide license for tesetaxel, a novel taxane
compound that is taken by mouth. Tesetaxel has completed Phase 2 trials in a number of cancer
types, and the drug has shown definite evidence of antitumor activity in gastric cancer and breast
cancer. Tesetaxel also appears to be associated with a lower incidence of peripheral nerve damage,
a common side effect of taxanes that limits the maximum amount of these drugs that can be given to
patients. At the time we obtained the license, tesetaxel was on clinical hold by FDA due to the
occurrence of several fatalities in the setting of severe neutropenia. In the second quarter of
2008, we filed a response to the FDA requesting a lift of the clinical hold, which was granted on
June 23, 2008. Before clinical testing can resume, we plan to submit to FDA an amendment to the
existing Drug Master File for a change in the manufacturing process. We are currently determining
the sites that will participate in the initial clinical trial that has been allowed by FDA.
The tesetaxel program seeks to secure a first-to-market advantage for tesetaxel relative to
other oral taxanes. We believe success in this competitive endeavor will maximize return to
stockholders. Accordingly, we have identified three oncology indications in which we believe
tesetaxel may have sufficient efficacy and safety to warrant regulatory approval. We believe it may
be possible to secure regulatory approval in these indications on the basis of endpoints that can
be achieved in clinical trials that may be relatively limited in scope.
In addition to these three smaller indications, the Company is interested in examining the
activity of tesetaxel in patients with hormone-refractory prostate cancer (HRPC). Docetaxel
(Taxotere®) is the only taxane approved for first-line use in patients with HRPC.
Although docetaxel has been shown to extend survival in men with HRPC, its use is associated with a
high incidence of moderate-to severe toxicity. If tesetaxel is shown to be active in HRPC, we
believe its safety profile may be substantially superior to docetaxel and may supplant that drug
for first-line use in this indication. However, the development of drugs in this indication is very
costly. Additional funding will be required to support the extended clinical testing that will be
required to secure regulatory approval in HRPC.
23
Our third pipeline product is G4544, which is a novel oral formulation of a gallium-containing
compound that we developed in collaboration with Emisphere Technologies, Inc. We completed a
single-dose Phase 1 study of an initial formulation of this new drug known as G4544(a) and the
results were presented at a scientific meeting in the second quarter of 2008. We are planning
another study using a modified formulation, known as G4544(b). The FDA has indicated that a
limited, animal toxicology study in a single species will be required prior to initiation of
multi-dose studies of G4544(b). Progress in the clinical development of G4544 program was delayed
in 2008 due to financial constraints, but we currently expect to continue our program as planned.
We currently intend to pursue a 505(b)(2) strategy to establish bioequivalence to our marketed
product, Ganite®, for the initial regulatory approval of G4544. However, we believe
this drug may also be useful for treatment of other diseases associated with accelerated bone loss,
such as bone metastases, Pagets disease and osteoporosis. In addition, new uses of
gallium-containing compounds have been identified for treatment of certain infectious diseases,
particularly severe infections involving the bacteria Pseudomonas aeruginosa, which are frequently
lethal in patients with cancer and cystic fibrosis. While we have no current plans to begin
clinical development in the area of infectious disease, we intend to support research conducted by
certain academic institutions by providing clinical supplies of our gallium-containing drugs.
Lastly, we have announced our intention to seek a buyer for Ganite®, our sole
marketed product. Our financial constraints have prevented us from investing in adequate
commercial support for Ganite®, and the intellectual property that provided us with an
exclusive position in the United States has now expired.
Results of Operations for the Three Months Ended June 30, 2008 and June 30, 2007
|
|
|
|
|
|
|
|
|
($ thousands) |
|
2008 |
|
|
2007 |
|
Product
sales net |
|
$ |
131 |
|
|
$ |
105 |
|
Cost of goods sold |
|
|
29 |
|
|
|
26 |
|
|
|
|
|
|
|
|
Gross margin |
|
|
102 |
|
|
|
79 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
4,454 |
|
|
|
4,099 |
|
Selling, general and administrative |
|
|
2,587 |
|
|
|
4,735 |
|
Settlement of office lease obligation |
|
|
3,307 |
|
|
|
|
|
Reduction in liability for settlement of litigation, net |
|
|
(80 |
) |
|
|
(240 |
) |
|
|
|
|
|
|
|
Total operating expenses |
|
|
10,268 |
|
|
|
8,594 |
|
|
|
|
|
|
|
|
|
|
Other (expense)/income: |
|
|
|
|
|
|
|
|
Amortization of deferred financing costs |
|
|
(840 |
) |
|
|
0 |
|
Fair market
value conversion feature liability |
|
|
(720,000 |
) |
|
|
0 |
|
Fair market
value warrant liability |
|
|
(7,200 |
) |
|
|
0 |
|
All other (expense)/ income, net |
|
|
(158 |
) |
|
|
280 |
|
|
|
|
|
|
|
|
Total other (expense)/income, net |
|
|
(728,198 |
) |
|
|
280 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(738,364 |
) |
|
$ |
(8,235 |
) |
|
|
|
|
|
|
|
Product sales-net
Product sales-net of Ganite® were $131 thousand for the three months ended June 30,
2008, compared with $105 thousand for the three months ended June 30, 2007. Product sales-net in
2008 include $5 thousand through the named-patient program managed for us by IDIS Limited (a
privately owned company based in the United Kingdom), whereby IDIS distributes Ganite®
and Genasense® on a ''named patient basis. ''Named patient distribution refers to
the distribution or sale of a product to a specific healthcare professional for the treatment of an
individual patient.
24
Cost of goods sold
There was a higher cost of goods sold in the three months ended June 30, 2008 than in the
three months ended June 30, 2007 as a result of a larger number of units sold.
Research and development expenses
Research and development expenses were $4.5 million for the three months ended June 30, 2008,
compared with $4.1 million for the three months ended June 30, 2007. This increase was primarily
due to higher expenses from the AGENDA clinical trial, partially offset by lower payroll costs,
resulting from lower headcount. In April 2008 and in May 2008, we reduced our workforce to conserve
cash.
Research and development expenses incurred on the Genasense® project during the
three months ended June 30, 2008 were approximately $4.3 million, representing 96% of research and
development expenses.
Due to the significant risks and uncertainties inherent in the clinical development and
regulatory approval processes, the nature, timing and costs of the efforts necessary to complete
projects in development are subject to wide variability. Results from clinical trials may not be
favorable. Data from clinical trials are subject to varying interpretation and may be deemed
insufficient by the regulatory bodies that review applications for marketing approvals. As such,
clinical development and regulatory programs are subject to risks and changes that may
significantly impact cost projections and timelines.
Selling, general and administrative expenses
Selling, general and administrative expenses were $2.6 million for the three months ended June
30, 2008, compared with $4.7 million for the three months ended June 30, 2007. This decrease was
primarily due to lower payroll costs, resulting from the two reductions in workforce, as well as
lower administrative expenses.
Settlement of office lease obligation
In May 2008, we entered into an amendment of our Lease Agreement with The Connell Company,
(Connell) whereby the lease for one floor of our office space in Berkeley Heights, New Jersey was
terminated. Connell received a termination payment of $1.3 million, comprised of our security
deposits and will receive a future payment from us of $2.0 million upon the earlier of July 1, 2009
or our receipt of at least $5.0 million in upfront cash from a business development deal. We
accrued for the $2.0 million and it is included in accounts payable and accrued expenses on our
Consolidated Balance Sheets. This transaction resulted in an incremental $3.3 million in expenses
for the three months ended June 30, 2008.
Provision for settlement of litigation, net
In the fourth quarter of 2006, we recorded an expense of $5.3 million that provides for the
issuance of 2.0 million shares of Genta common stock, for a settlement in principle of class action
litigation. The expense is net of insurance recovery of $18.0 million. At June 30, 2007, the
revised estimated value of the common shares portion of the litigation settlement was $3.5 million,
resulting in a reduction in the provision of $0.2 million for the second quarter of 2007. At June
27, 2008, the date that the settlement became final, the revised value of the common stock portion
of the litigation settlement was $0.7 million, based on a closing price of Gentas common stock of
$0.35 per share, resulting in a reduction in the provision of $0.1 million for the second quarter
of 2008.
25
Amortization of deferred financing costs
On June 9, 2008, we issued $20 million of our senior secured convertible notes, issued our
private placement agent a warrant to purchase 40,000,000 shares of our common stock at an exercise
price of $0.02 per share and incurred a financing fee of $1.2 million. The deferred financing costs
including the financing fee and the issuance of the warrant are being amortized over the two-year
term of the convertible notes, resulting in amortization of $0.8 million in the month of June 2008.
Fair value conversion feature liability
On the issuance date there was an insufficient number of authorized shares of common stock in
order to permit exercise of all of the notes. In accordance with EITF 00-19, Accounting for
Derivative Financial Instruments Indexed to, and Potentially Settled in, a Companys Own Stock
(EITF 00-19),when there are insufficient authorized shares, the conversion obligation for the notes
should be classified as a liability measured at fair value on the balance sheet.
On June 9, 2008, based upon a Black-Scholes valuation model that included a closing price of
our common stock of $0.20 per share, we calculated a fair value of the conversion feature of $380.0
million and expensed $360.0 million, the amount that exceeded the proceeds of the $20.0 million
from the initial closing. On June 30, 2008, based upon a Black-Scholes valuation model that
included a closing price of our common stock of $0.38 per share, we expensed an additional $380.0
million to mark the conversion feature liability to market, resulting in a total expense in June of
$720.0 million.
Fair value warrant liability
The warrant was also treated as a liability and was recorded at a fair value of $7.6 million
based upon a Black-Scholes valuation model that included a closing price of our common stock of
$0.20 per share. On June 30, 2008, based on a Black-Scholes valuation model that included a closing
price of our common stock of $0.38 per share, we expensed $7.2 million to mark the warrant
liability to market.
We will continue to mark the convertible note and the warrant to market until the date that
stockholders approve an increase in the number of authorized shares. We are planning to have an
Annual Meeting of Stockholders later this year and our Board of Directors has recommended that
stockholders approve a charter amendment to increase the amount of our authorized shares. Once
stockholders approve an increase in the amount of authorized shares, the marked-to-market
liabilities for the conversion feature and the warrant will be transferred to Stockholders Equity.
All other (expense)/ income, net
Net other expense of $0.2 million for the three months ended June 30, 2008 unfavorably
compared to net other income of $0.3 million for the three months ended June 30, 2007 due to lower
investment income, resulting from lower investment balances and accrued interest on the recently
issued convertible notes.
Net loss
Genta incurred a net loss of $738.4 million, or ($20.10) per share, for the three months ended
June 30, 2008 and $8.2 million, or ($0.27) per share, for the three months ended June 30, 2007.
The larger net loss in 2008 is primarily due to the mark-to-market charge on the conversion
feature liability of $720.0 million, the mark-to-market charge on the warrant liability of $7.2
million, the expenses resulting from the reduction in our office space of $3.3 million, higher
expenses resulting from the AGENDA clinical trial and the amortization of deferred financing costs
of $0.8 million, slightly offset by lower payroll costs, resulting from the two reductions in
workforce, as well as lower administrative expenses.
26
Results of Operations for the Six Months Ended June 30, 2008 and June 30, 2007
|
|
|
|
|
|
|
|
|
($ thousands) |
|
2008 |
|
|
2007 |
|
Product sales net |
|
$ |
248 |
|
|
$ |
199 |
|
Cost of goods sold |
|
|
54 |
|
|
|
48 |
|
|
|
|
|
|
|
|
Gross margin |
|
|
194 |
|
|
|
151 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
10,891 |
|
|
|
7,481 |
|
Selling, general and administrative |
|
|
6,225 |
|
|
|
8,787 |
|
Settlement of office lease obligation |
|
|
3,307 |
|
|
|
|
|
Reduction in liability for settlement of litigation, net |
|
|
(340 |
) |
|
|
(1,800 |
) |
|
|
|
|
|
|
|
Total operating expenses |
|
|
20,083 |
|
|
|
14,468 |
|
|
|
|
|
|
|
|
|
|
Other (expense)/income: |
|
|
|
|
|
|
|
|
Amortization of deferred financing costs |
|
|
(840 |
) |
|
|
0 |
|
Fair market value conversion feature liability |
|
|
(720,000 |
) |
|
|
0 |
|
Fair market value warrant liability |
|
|
(7,200 |
) |
|
|
0 |
|
All other (expense)/ income, net |
|
|
(92 |
) |
|
|
478 |
|
|
|
|
|
|
|
|
Total other (expense)/income, net |
|
|
(728,132 |
) |
|
|
478 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(748,021 |
) |
|
$ |
(13,839 |
) |
|
|
|
|
|
|
|
Product sales-net
Product sales-net of Ganite® were $248 thousand for the six months ended June 30,
2008, compared with $199 thousand for the six months ended June 30, 2007. Product sales-net in 2008
includes $15 thousand through the named-patient program managed for us by IDIS.
Cost of goods sold
There was a higher cost of goods sold in the six months ended June 30, 2008 than in the six
months ended June 30, 2007 as a result of a larger number of units sold.
Research and development expenses
Research and development expenses were $10.9 million for the six months ended June 30, 2008,
compared with $7.5 million for the six months ended June 30, 2007. This increase was primarily due
to the recognition in March 2008 of $2.5 million for license payments on tesetaxel and higher
expenses from the AGENDA clinical trial, partially offset by lower payroll costs, resulting from
lower headcount.
Research and development expenses incurred on the Genasense® project during the six
months ended June 30, 2008 were approximately $7.7 million, representing 70% of research and
development expenses, (including the $2.5 million for license payments of tesetaxel). Excluding the
expense of $2.5 million that was recorded for license payments of tesetaxel, research and
development expenses incurred on the Genasense® represented 92% of research and
development expenses.
Selling, general and administrative expenses
Selling, general and administrative expenses were $6.2 million for the six months ended June
30, 2008, compared with $8.8 million for the six months ended June 30, 2007. The decrease is
primarily due to our efforts at lowering administrative expenses and lower payroll costs, resulting
from the two reductions in workforce.
27
Provision for settlement of litigation, net
From January 1, 2008 through June 27, 2008, the date that the settlement of class action
litigation became final, the reduction in the price of Gentas common stock resulted in a reduction
in the provision of $0.3 million. During the six months ended June 30, 2007, the provision for
settlement of litigation declined $1.8 million due to the reduction in the price of our common
stock.
All other (expense)/ income, net
Net other expense of $0.1 million for the six months ended June 30, 2008 unfavorably compared
to net other income of $0.5 million for the six months ended June 30, 2007 due to lower investment
income, resulting from lower investment balances and accrued interest on the recently issued
convertible notes.
Net loss
Genta incurred a net loss of $748.0 million, or $21.21 per share, for the six months ended
June 30, 2008 and $13.8 million, or $0.48 per share, for the six months ended June 30, 2007.
The larger net loss in 2008 is primarily due to the mark-to-market charge on the conversion
feature liability of $720.0 million, the mark-to-market charge on the warrant liability of $7.2
million, the expenses resulting from the reduction in our office space of $3.3 million, the
recognition in March 2008 for our license payments on tesetaxel of $2.5 million, higher expenses
resulting from the AGENDA clinical trial and the amortization of deferred financing costs of $0.8
million, slightly offset by lower payroll costs, resulting from the two reductions in workforce, as
well as lower administrative expenses.
Liquidity and Capital Resources
At June 30, 2008, we had cash, cash equivalents and marketable securities totaling $16.3
million compared with $7.8 million at December 31, 2007 reflecting in part, the net proceeds from
the placement of $20 million of notes on June 9, 2008.
The notes bear interest at an annual rate of 15% payable at quarterly intervals in stock or
cash at our option, and the notes are convertible into shares of Genta common stock at a conversion
rate of 100,000 shares of common stock for every $1,000.00 of principal. Holders of the notes have
the right, but not the obligation, for the following 12 months following the initial closing date
to purchase in whole or in part up to an additional $20 million of the notes. We have the right to
force conversion of the notes in whole or in part if the closing bid price of our common stock
exceeds $0.50 for a period of 20 consecutive trading days. Certain members of our senior management
participated in this offering. The notes are secured by a first lien on all of our assets. The
notes include certain events of default, including a requirement that we obtain stockholder
approval within a specified period of time to amend our certificate of incorporation to authorize
additional shares of common stock. In addition, the notes prohibit any additional financing without
the approval of holders of more than two-thirds of the principal amount of the notes.
Upon the occurrence of an event of default, holders of the notes have the right to require us
to prepay all or a portion of their notes as calculated as the greater of (a) 150% of the aggregate
principal amount of the note plus accrued interest or (b) the aggregate principal amount of the
note plus accrued interest divided by the conversion price; multiplied by a weighted average price
of our common stock. Pursuant to a general security agreement, entered into concurrent with the
notes, the notes are secured by a first lien on all of our assets.
During the first six months of 2008, cash used in operating activities was $14.4 million
compared with $16.8 million for the same period in 2007. Lower cash used in operating activities
was primarily due to the timing of payments in the two respective periods.
In February 2008, we sold 6.1 million shares of our common stock at a price of $0.50 per
share, raising approximately $3.1 million, before estimated fees and expenses of approximately $203
thousand.
28
Effective May 7, 2008, we moved the trading of our common stock from The NASDAQ Capital
Markets to the Over-the-Counter Bulletin Board (OTCBB) maintained by FINRA (formerly, the NASD).
This action was taken pursuant to receipt of notification from the NASDAQ Listing Qualifications
Panel that we had failed to demonstrate our ability to sustain compliance with the $2.5 million
minimum stockholders equity requirement for continued listing on The NASDAQ Capital Markets. On
July 10, 2008, we received notification from The NASDAQ Capital Market that The NASDAQ Capital
Market had determined to remove our common stock from listing on such exchange. The delisting was
effective at the opening of the trading session on July 21, 2008.
Irrespective of whether an NDA or MAA for Genasense® are approved, we will require
additional cash in order to maximize this commercial opportunity and to continue its clinical
development opportunities. We have had discussions with other companies regarding partnerships for
the further development and global commercialization of Genasense®. Additional
alternatives available to us to sustain our operations include financing arrangements with
potential corporate partners, debt financing, asset-based loans, royalty-based financing, equity
financing, profits from named-patient sales, and other potential sources of financing. However,
there can be no assurance that any such collaborative agreements or other sources of funding will
be available to us on favorable terms, if at all.
We will continue to maintain an appropriate level of spending over the upcoming fiscal year,
given the uncertainties inherent in our business and our current liquidity position. Presently,
with no further financing, we project that we will run out of funds in the first quarter of 2009.
We currently do not have any additional financing in place. If we are unable to raise additional
financing, we could be required to reduce our spending plans, reduce our workforce, license to
others products or technologies we would otherwise seek to commercialize ourselves and sell certain
assets. There can be no assurance that we can obtain financing, if at all, on terms acceptable to
us.
We anticipate seeking additional product development opportunities through potential
acquisitions or investments. Such acquisitions or investments may consume cash reserves or require
additional cash or equity. Our working capital and additional funding requirements will depend upon
numerous factors, including: (i) the progress of our research and development programs; (ii) the
timing and results of pre-clinical testing and clinical trials; (iii) the level of resources that
we devote to sales and marketing capabilities; (iv) technological advances; (v) the activities of
competitors; (vi) our ability to establish and maintain collaborative arrangements with others to
fund certain research and development efforts, to conduct clinical trials, to obtain regulatory
approvals and, if such approvals are obtained, to manufacture and market products and (vii) legal
costs and the outcome of outstanding legal proceedings.
Recent Accounting Pronouncements
In December 2007, the FASB issued SFAS 141(R), Business Combinations (SFAS 141(R)), which
replaces SFAS 141. SFAS 141(R) establishes principles and requirements for how an acquirer in a
business combination recognizes and measures in its financial statements the identifiable assets
acquired, the liabilities assumed, and any controlling interest; recognizes and measures the
goodwill acquired in the business combination or a gain from a bargain purchase; and determines
what information to disclose to enable users of the financial statements to evaluate the nature and
financial effects of the business combination. SFAS 141(R) is to be applied prospectively to
business combinations for which the acquisition date is on or after an entitys fiscal year that
begins after December 15, 2008. The Company will assess the impact of SFAS 141(R) if and when a
future acquisition occurs.
29
In December 2007, the FASB issued SFAS 160, Noncontrolling Interests in Consolidated
Financial Statements an amendment of ARB No. 51 (SFAS 160). SFAS 160 establishes new
accounting and reporting standards for the noncontrolling interest in a subsidiary and for the
deconsolidation of a subsidiary. Specifically, this statement requires the recognition of a
noncontrolling interest (minority interest) as equity in the consolidated financial statements and
separate from the parents equity. The amount of net income attributable to the noncontrolling
interest will be included in consolidated net income on the face of the income statement. SFAS 160
clarifies that changes in a parents ownership interest in a subsidiary that do not result in
deconsolidation are equity transactions if the parent retains its controlling financial interest.
In addition, this statement requires that a parent recognize a gain or loss in net income when a
subsidiary is deconsolidated. SFAS 160 also includes expanded disclosure requirements regarding the
interests of the parent and its noncontrolling interest. SFAS 160 is effective for fiscal years,
and interim periods within those fiscal years, beginning on or after December 15, 2008. The Company
does not expect that adoption of this standard will have a material impact on its financial
statements.
In December 2007, the Securities and Exchange Commission (SEC) issued Staff Accounting
Bulletin 110 (SAB 110), which permits entities, under certain circumstances, to continue to use
the simplified method of estimating the expected term of plain options as discussed in SAB No.
107 and in accordance with SFAS 123R. The guidance in this release is effective January 1, 2008.
The impact of this standard on the consolidated financial statements did not have a material
effect.
In December 2007, the FASB issued EITF Issue No. 07-1, Accounting for Collaborative
Arrangements, which is effective for calendar year companies on January 1, 2009. The Task Force
clarified the manner in which costs, revenues and sharing payments made to, or received by, a
partner in a collaborative arrangement should be presented in the income statement and set forth
certain disclosures that should be required in the partners financial statements. The Company is
currently assessing the potential impacts of implementing this standard.
In June 2007, the FASB issued EITF Issue No. 07-3, Accounting for Nonrefundable Advance
Payments for Goods or Services Received for Use in Future Research and Development Activities,
which is effective for calendar year companies on January 1, 2008. The Task Force concluded that
nonrefundable advance payments for goods or services that will be used or rendered for future
research and development activities should be deferred and capitalized. Such amounts should be
recognized as an expense as the related goods are delivered or the services are performed, or when
the goods or services are no longer expected to be provided. The impact of this standard on the
consolidated financial statements did not have a material effect.
In February 2007, the FASB issued SFAS 159, The Fair Value Option for Financial Assets and
Financial Liabilities (SFAS 159). SFAS 159 permits all entities to choose to elect, at specified
election dates, to measure eligible financial instruments at fair value. An entity shall report
unrealized gains and losses on items for which the fair value option has been elected in earnings
at each subsequent reporting date and recognize upfront costs and fees related to those items in
earnings as incurred and not deferred. SFAS 159 applies to fiscal years beginning after November
15, 2007, with early adoption permitted for an entity that has also elected to apply the provisions
of SFAS 157, Fair Value Measurements. The impact of this standard on the consolidated financial
statements did not have a material effect.
In September 2006, the FASB issued SFAS 157, Fair Value Measurements. SFAS 157 defines fair
value, establishes a framework for measuring fair value in accordance with accounting principles
generally accepted in the United States of America and expands disclosures about fair value
measurements. SFAS 157 applies under other accounting pronouncements that require or permit fair
value measurements. Accordingly, this pronouncement does not require any new fair value
measurements. The Company was required to adopt SFAS 157 beginning January 1, 2008. The impact of
this standard on the consolidated financial statements did not have a material effect.
30
Critical Accounting Policies and Estimates
Our significant accounting policies are more fully described in Note 3 to our consolidated
financial statements. In preparing our financial statements in accordance with accounting
principles generally accepted in the United States of America, management is required to make
estimates and assumptions that, among other things, affect the reported amounts of assets and
liabilities and reported amounts of revenues and expenses. These estimates are most significant in
connection with our critical accounting policies, namely those of our accounting policies that are
most important to the portrayal of our financial condition and results and require managements
most difficult, subjective or complex judgments. These judgments often result from the need to make
estimates about the effects of matters that are inherently uncertain. Actual results may differ
from those estimates under different assumptions or conditions. We believe that the following
represents our critical accounting policies:
|
|
|
Going concern. Our recurring losses from operations and negative cash flows from
operations raise substantial doubt about our ability to continue as a going concern and as
a result, our independent registered public accounting firm included an explanatory
paragraph in its report on our consolidated financial statement for the year ended
December 31, 2007 with respect to this uncertainty. We have prepared our financial
statements on a going concern basis, which contemplates the realization of assets and the
satisfaction of liabilities and commitments in the normal course of business. The
financial statements do not include any adjustments relating to the recoverability and
classification of recorded asset amounts or amounts of liabilities that might be necessary
should we be unable to continue in existence. |
|
|
|
|
Revenue recognition. We recognize revenue from product sales when title to product and
associated risk of loss has passed to the customer and we are reasonably assured of
collecting payment for the sale. All revenue from product sales are recorded net of
applicable allowances for returns, rebates and other applicable discounts and allowances.
We allow return of our product for up to twelve months after product expiration. |
|
|
|
|
Research and development costs. All such costs are expensed as incurred, including raw
material costs required to manufacture drugs for clinical trials. |
|
|
|
|
Estimate of fair value of convertible notes and warrant. We use a Black-Scholes model
to estimate the fair value of our convertible notes and warrant.
|
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Our carrying values of cash, marketable securities, accounts payable, accrued expenses and
debt are a reasonable approximation of their fair value. The estimated fair values of financial
instruments have been determined by us using available market information and appropriate valuation
methodologies. We have not entered into and do not expect to enter into, financial instruments for
trading or hedging purposes. We do not currently anticipate entering into interest rate swaps
and/or similar instruments.
Our primary market risk exposure with regard to financial instruments is to changes in
interest rates, which would impact interest income earned on such instruments. We have no material
currency exchange or interest rate risk exposure as of June 30, 2008. Therefore, there will be no
ongoing exposure to a potential material adverse effect on our business, financial condition or
results of operation for sensitivity to changes in interest rates or to changes in currency
exchange rates.
31
Item 4T. Controls and Procedures
Conclusion Regarding the Effectiveness of Disclosure Controls and Procedures
As required by Rule 13a-15(b), Gentas Chief Executive Officer and Principal Accounting and
Financial Officer conducted an evaluation as of the end of the period covered by this report of the
effectiveness of the Companys disclosure controls and
procedures (as defined in Exchange Act
Rule 13a-15(e)). Based on that evaluation, the Chief Executive Officer and Principal Accounting and
Financial Officer concluded that the Companys disclosure controls and procedures were effective as
of the end of the period covered by this report.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting identified in
connection with the evaluation required by paragraph (d) of Exchange Act Rule 13a-15 that occurred
during the period covered by this report that have materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
32
PART II
Item 1. Legal Proceedings
In 2004, numerous complaints were filed in the United States District Court for the District
of New Jersey, or the Court, against Genta and certain of its principal officers on behalf of
purported classes of the Companys stockholders who purchased its securities during several class
periods. The complaints were consolidated into a single action and alleged that the Company and
certain of its principal officers violated the federal securities laws by issuing materially false
and misleading statements regarding Genasense® for the treatment of malignant melanoma that had the
effect of artificially inflating the market price of the Companys securities. The stockholder
class action complaint sought monetary damages in an unspecified amount and recovery of plaintiffs
costs and attorneys fees. The Company reached an agreement with plaintiffs to settle the class
action litigation in consideration for the issuance of 2.0 million shares of common stock of the
Company (adjusted for any subsequent event that results in a change in the number of shares
outstanding as of January 31, 2007) and $18.0 million in cash for the benefit of plaintiffs and the
stockholder class. The cash portion of the proposed settlement will be covered by the Companys
insurance carriers. Effective June 25, 2007, the Company and plaintiffs executed a written
Stipulation and Agreement of Settlement which was filed with the Court on August 13, 2007, seeking
preliminary approval. The unopposed Motion for Preliminary Approval of Settlement was granted on
October 30, 2007, and the Court held a hearing on plaintiffs unopposed motion for final approval
of the settlement on March 3, 2008. An order approving the settlement was issued on May 27, 2008
and the settlement became final on June 27, 2008.
The settlement did not constitute an admission of guilt or liability.
In February 2007, a complaint against the Company was filed in the Superior Court of New
Jersey by Howard H. Fingert, M.D., a former employee of the Company. The complaint alleges, among
other things, breach of contract as to the Companys stock option plan and as to a consulting
agreement allegedly entered into by the Company and Dr. Fingert subsequent to termination of Dr.
Fingerts employment with the Company, breach of implied covenant of good faith and fair dealing
with respect to the Companys stock option plan and the alleged consulting agreement, promissory
estoppel with respect to the exercise of stock options and provision of consulting services after
termination of employment, and fraud and negligent misrepresentation with respect to the exercise
of stock options and provision of consulting services after termination of employment. The
complaint seeks monetary damages, including punitive and consequential damages. The Company filed
an answer to the complaint on May 29, 2007, and on August 8, 2007, filed a request for production
of documents. On January 4, 2008, the Court dismissed the complaint without prejudice due to Dr.
Fingerts failure to produce the requested discovery. Dr. Fingert filed a motion dated March 24,
2008 to reinstate the complaint, which was granted by the Court on April 11, 2008 at which time the
Court adopted a discovery schedule that concludes in December 2008. The Company denies the
allegations in the complaint and intends to vigorously defend this lawsuit.
In November 2007, a complaint against the Company was filed in the United States District
Court for the District of New Jersey by Ridge Clearing & Outsourcing Solutions, Inc. The complaint
alleges, among other things, that the Company caused or contributed to losses suffered by a Company
stockholder, which have been incurred by Ridge. The Company filed its Answer and Affirmative
Defenses on February 27, 2008 to respond to the complaint. The Company denies the allegations in
the complaint and intends to vigorously defend this lawsuit.
33
Item 1A. Risk Factors
You should carefully consider the following risks and all of the other information set forth
in this Form 10-Q and the Form 10-K for the year ended December 31, 2007 before deciding to invest
in shares of our common stock. The risks described below are not the only ones facing our Company.
Additional risks not presently known to us or that we currently deem immaterial may also impair our
business operations.
If any of the following risks actually occurs, our business, financial condition or results of
operations would likely suffer. In such case, the market price of our common stock would likely
decline due to the occurrence of any of these risks, and you may lose all or part of your
investment.
Risks Related to Our Business
If our stockholders do not approve our amended certificate of incorporation, we will be in a
default under the terms of the June 2008 convertible note financing.
At our annual meeting of stockholders to be
held later in 2008, we have requested that our
stockholders approve an amendment to our restated certificate of incorporation, as amended, to
increase the total number of authorized shares of capital stock available for issuance from
255,000,000, consisting of 250,000,000 shares of common stock and 5,000,000 shares of preferred
stock, to 6,005,000,000, consisting of 6,000,000,000 shares of common stock and 5,000,000 shares of
preferred stock. The amendment would satisfy the conditions contained in the terms of the
convertible note financing. We have recommended that the stockholders vote in favor of such
proposal.
We cannot guarantee that such amendment will be approved by our stockholders and will not
result in a breach under the terms of the June 2008 convertible note financing. If such amendment
is not approved by our stockholders, we will be in default under the terms of the June 2008
convertible note financing. Upon an event of default, the holders may require prepayment of
principal, plus accrued interest under the notes, plus a premium as set forth in the notes. This
event would likely have a harmful effect on the company, including the possibility of bankruptcy.
We may be unsuccessful in our efforts to obtain approval from the FDA or EMEA and commercialize
Genasense® or our other pharmaceutical products.
The commercialization of our pharmaceutical products involves a number of significant
challenges. In particular, our ability to commercialize products, such as Ganite® and
Genasense®, depends, in large part, on the success of our clinical development programs,
our efforts to obtain regulatory approvals and our sales and marketing efforts directed at
physicians, patients and third-party payors. A number of factors could affect these efforts,
including:
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our ability to demonstrate clinically that our products are useful and safe in
particular indications; |
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delays or refusals by regulatory authorities in granting marketing approvals; |
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our limited financial resources and sales and marketing experience relative to our
competitors; |
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actual and perceived differences between our products and those of our competitors; |
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the availability and level of reimbursement for our products by third-party payors; |
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incidents of adverse reactions to our products; |
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side effects or misuse of our products and the unfavorable publicity that could result;
and |
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the occurrence of manufacturing, supply or distribution disruptions. |
34
We cannot assure you that Genasense® will receive FDA or EMEA approval. Our
financial condition and results of operations have been and will continue to be significantly
affected by FDA and EMEA action with respect to Genasense®. Any adverse events with
respect to FDA and/or EMEA approvals could negatively impact our ability to obtain additional
funding or identify potential partners.
For example, in December 2005, we completed submission of an NDA to the FDA that sought
accelerated approval for the use of Genasense® in combination with fludarabine plus
cyclophosphamide for the treatment of patients with relapsed or refractory CLL who had previously
received fludarabine. In September 2006, an ODAC meeting voted not to recommend approval of
Genasense® in CLL, and in December 2006, we received a non-approvable notice from the
FDA. We believe that our application met the regulatory requirements for approval, and in April
2007, we filed an appeal of this non-approvable notice pursuant to the FDAs Formal Dispute
Resolution process that exists within the FDAs Center for Drug Evaluation and Research (CDER). In
June 2007, we announced that the initial appeal was denied and that we would further appeal the
decision to the next level within CDER. On October 25, 2007, we announced that we had completed the
filing of our next-level formal appeal to CDER.
On March 17, 2008, we announced that CDER had decided that additional confirmatory evidence
would be required to support approval of Genasense® for treatment of patients with CLL.
CDER acknowledged that complete response, which was the primary endpoint in the pivotal trial, was
an appropriate endpoint for assessing efficacy. FDA also agreed that this endpoint was achieved,
and that those results supported the efficacy of the drug. CDER recommended two alternatives for
exploring the efficacy of Genasense® that could provide such confirmatory evidence. One
option was to conduct an additional clinical trial. The other option was to collect additional
information regarding the clinical course and progression of disease in patients from the completed
trial. We currently plan to pursue both of these options. Information from the completed trial
should be available by the third quarter of 2008. In the second quarter of 2008, we submitted a new
protocol seeking Special Protocol Assessment (SPA) from the FDA and Scientific Advice from the
EMEA. This protocol is similar in design to the completed trial and uses the same chemotherapy and
randomization scheme. The major difference is that the trial focuses on the patient population who
derived maximal benefit in the completed trial. This group is characterized by patients who had
received less extensive chemotherapy prior to entering the trial and who were defined as being
non-refractory to fludarabine. The earliest date this new trial could begin patient accrual would
be the fourth quarter of 2008. However, we do not currently have sufficient resources to finance
this trial, and at present we do not expect to begin this trial absent funding from a partnership
or other sources.
In January 2006, we completed a MAA to the EMEA, which sought approval for use of
Genasense® plus dacarbazine for the treatment of patients with advanced melanoma who had
not previously received chemotherapy. In April 2007, we were informed that the Committee for
Medicinal Products for Human Use (CHMP) of the EMEA had issued a negative opinion on the MAA and we
indicated that we would seek re-examination of the MAA by a Scientific Advisory Group. In July
2007, we received notice from the EMEA that the requested re-examination by a Scientific Advisory
Group had reaffirmed the negative opinion. We contemplate no further action on the MAA.
Ultimately, our efforts may not prove to be as effective as those of our competitors. In the
United States and elsewhere, our products will face significant competition. The principal
conditions on which our product development efforts are focused and some of the other disorders for
which we are conducting additional studies, are currently treated with several drugs, many of which
have been available for a number of years or are available in inexpensive generic forms. Thus, even
if we obtain regulatory approvals, we will need to demonstrate to physicians, patients and
third-party payors that the cost of our products is reasonable and appropriate in light of their
safety and efficacy, the price of competing products and the relative health care benefits to the
patient. If we are unable to demonstrate that the costs of our products are reasonable and
appropriate in light of these factors, we will likely be unsuccessful in commercializing our
products.
35
Recurring losses and negative cash flows from operations raise substantial doubt about our
ability to continue as a going concern and we may not be able to continue as a going concern.
Our recurring losses from operations and negative cash flows from operations raise substantial
doubt about our ability to continue as a going concern and as a result, our independent registered
public accounting firm included an explanatory paragraph in its report on our consolidated
financial statement for the year ended December 31, 2007 with respect to this uncertainty.
Substantial doubt about our ability to continue as a going concern may create negative reactions to
the price of the common shares of our stock and we may have a more difficult time obtaining
financing.
We have prepared our financial statements on a going concern basis, which contemplates the
realization of assets and the satisfaction of liabilities and commitments in the normal course of
business. The financial statements do not include any adjustments relating to the recoverability
and classification of recorded asset amounts or amounts of liabilities that might be necessary
should we be unable to continue in existence.
Our business will suffer if we fail to obtain additional funding.
Our operations to date have required significant cash expenditures. Our future capital
requirements will depend on the results of our research and development activities, preclinical
studies and clinical trials, competitive and technological advances, and regulatory activities of
the FDA and other regulatory authorities. In order to commercialize our products, seek new product
candidates and continue our research and development programs, we will need to raise additional
funds.
On June 5, 2008, the Company entered into definitive agreements with institutional and
accredited investors to place senior secured convertible notes due 2010 totaling in aggregate up to
$40 million in gross proceeds before fees and expenses. The closing of the first $20 million of
notes took place on June 9, 2008.
The notes bear interest at an annual rate of 15% payable at quarterly intervals in stock or
cash at the Companys option, and are convertible into shares of Genta common stock at a conversion
rate of 100,000 shares of common stock for every $1,000.00 of principal. Holders of the notes have
the right, but not the obligation, for the following 12 months following the initial closing date
to purchase in whole or in part up to an additional $20 million of the notes. The Company shall
have the right to force conversion of the notes in whole or in part if the closing bid price of the
Companys common stock exceeds $0.50 for a period of 20 consecutive trading days. Certain members
of our senior management participated in this offering. The notes are secured by a first lien on
all assets of Genta. The notes include certain events of default, including a requirement that the
Company obtain stockholder approval within a specified period of time to amend its certificate of
incorporation to authorize additional shares of common stock.
If we are unable to raise additional funds, we will need to do one or more of the following:
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delay, scale back or eliminate some or all of our research and product development
programs; |
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license third parties to develop and commercialize products or technologies that we
would otherwise seek to develop and commercialize ourselves; |
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attempt to sell our company; |
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cease operations; or |
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declare bankruptcy. |
36
We will maintain an appropriate level of spending over the upcoming fiscal year, given the
uncertainties inherent in our business and our current liquidity position. Presently, with no
further financing, we will run out of funds in the first quarter of 2009. We currently do not have
any additional financing in place. If we are unable to raise additional financing, we could be
required to reduce our spending plans, reduce our workforce, license to others products or
technologies we would otherwise seek to commercialize ourselves and sell certain assets. There can
be no assurance that we can obtain financing, if at all, on terms acceptable to us.
We have relied on and continue to rely on our contractual collaborative arrangements with
research institutions and corporate partners for development and commercialization of our
products. Our business could suffer if we are not able to enter into suitable arrangements,
maintain existing relationships, or if our collaborative arrangements are not successful in
developing and commercializing products.
We have entered into collaborative relationships relating to the conduct of clinical research
and other research activities in order to augment our internal research capabilities and to obtain
access to specialized knowledge and expertise. Our business strategy depends in part on our
continued ability to develop and maintain relationships with leading academic and research
institutions and with independent researchers. The competition for these relationships is intense,
and we can give no assurances that we will be able to develop and maintain these relationships on
acceptable terms.
We also seek strategic alliances with corporate partners, primarily pharmaceutical and
biotechnology companies, to help us develop and commercialize drugs. Various problems can arise in
strategic alliances. A partner responsible for conducting clinical trials and obtaining regulatory
approval may fail to develop a marketable drug. A partner may decide to pursue an alternative
strategy or focus its efforts on alliances or other arrangements with third parties. A partner that
has been granted marketing rights for a certain drug within a geographic area may fail to market
the drug successfully. Consequently, strategic alliances that we may enter into may not be
scientifically or commercially successful.
We cannot control the resources that any collaborator may devote to our products. Any of our
present or future collaborators may not perform their obligations as expected. These collaborators
may breach or terminate their agreements with us, for instance upon changes in control or
management of the collaborator, or they may otherwise fail to conduct their collaborative
activities successfully and in a timely manner.
In addition, our collaborators may elect not to develop products arising out of our
collaborative arrangements or to devote sufficient resources to the development, regulatory
approval, manufacture, marketing or sale of these products. If any of these events occur, we may
not be able to develop our products or commercialize our products.
An important part of our strategy involves conducting multiple product development programs.
We may pursue opportunities in fields that conflict with those of our collaborators. In addition,
disagreements with our collaborators could develop over rights to our intellectual property. The
resolution of such conflicts and disagreements may require us to relinquish rights to our
intellectual property that we believe we are entitled to. In addition, any disagreement or conflict
with our collaborators could reduce our ability to obtain future collaboration agreements and
negatively impact our relationship with existing collaborators. Such a conflict or disagreement
could also lead to delays in collaborative research, development, regulatory approval or
commercialization of various products or could require or result in litigation or arbitration,
which would be time consuming and expensive, divert the attention of our management and could have
a significant negative impact on our business, financial condition and results of operations.
37
We anticipate that we will incur additional losses and we may never be profitable.
We have never been profitable. We have incurred substantial annual operating losses associated
with ongoing research and development activities, preclinical testing, clinical trials, regulatory
submissions and manufacturing activities. From the period since our inception to June 30, 2008, we
have incurred a cumulative net deficit of $1,186.3 million. We may never achieve revenue sufficient
for us to attain profitability. Achieving profitability is unlikely unless Genasense®
receives approval from the FDA or EMEA for commercial sale in one or more indications.
Our business depends heavily on a small number of products.
We currently market and sell one product, Ganite® and the principal patent covering
its use for the approved indication expired in April 2005. If Genasense® is not
approved, if approval is significantly delayed, or if in the event of approval the product is
commercially unsuccessful, we do not expect significant sales of other products to offset this loss
of potential revenue.
To diversify our product line in the long term, it will be important for us to identify
suitable technologies and products for acquisition or licensing and development. If we are unable
to identify suitable technologies and products, or if we are unable to acquire or license products
we identify, we may be unable to diversify our product line and to generate long-term growth.
We may be unable to obtain or enforce patents, other proprietary rights and licenses to protect
our business; we could become involved in litigation relating to our patents or licenses that
could cause us to incur additional costs and delay or prevent our introduction of new drugs to
market.
Our success will depend to a large extent on our ability to:
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obtain U.S. and foreign patent or other proprietary protection for our technologies,
products and processes; |
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preserve trade secrets; and |
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operate without infringing the patent and other proprietary rights of third parties. |
Legal standards relating to the validity of patents covering pharmaceutical and
biotechnological inventions and the scope of claims made under these types of patents are still
developing, and they involve complex legal and factual questions. As a result, our ability to
obtain and enforce patents that protect our drugs is highly uncertain. If we are unable to obtain
and enforce patents and licenses to protect our drugs, our business, results of operations and
financial condition could be adversely affected.
We hold numerous U.S., foreign and international patents covering various aspects of our
technology, which include novel compositions of matter, methods of large-scale synthesis and
methods of controlling gene expression and methods of treating disease. In the future, however, we
may not be successful in obtaining additional patents despite pending or future applications.
Moreover, our current and future patents may not be sufficient to protect us against competitors
who use similar technology. Additionally, our patents, the patents of our business partners and the
patents for which we have obtained licensing rights may be challenged, narrowed, invalidated or
circumvented. Furthermore, rights granted under our patents may not be broad enough to cover
commercially valuable drugs or processes, and therefore, may not provide us with sufficient
competitive advantage with respect thereto.
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The pharmaceutical and biotechnology industries have been greatly affected by time-consuming
and expensive litigation regarding patents and other intellectual property rights. We may be
required to commence, or may be made a party to, litigation relating to the scope and validity of
our intellectual property rights or the intellectual property rights of others. Such litigation
could result in adverse decisions regarding the patentability of our inventions and products, the
enforceability, validity or scope of protection offered by our patents or our infringement of
patents held by others. Such decisions could make us liable for substantial money damages, or could
bar us from the manufacture, sale or use of certain products. Moreover, an adverse decision may
also compel us to seek a license from a third party. The costs of any license may be prohibitive
and we may not be able to enter into any required licensing arrangement on terms acceptable to us.
The cost to us of any litigation or proceeding relating to patent or license rights, even if
resolved in our favor, could be substantial. Some of our competitors may be able to sustain the
costs of complex patent or licensing litigation more effectively than we can because of their
substantially greater resources. Uncertainties resulting from the initiation and continuation of
any patent or related litigation could have a material adverse effect on our ability to compete in
the marketplace.
We also may be required to participate in interference proceedings declared by the U.S. Patent
and Trademark Office in opposition or similar proceedings before foreign patent offices and in
International Trade Commission proceedings aimed at preventing the importation of drugs that would
compete unfairly with our drugs. These types of proceedings could cause us to incur considerable
costs.
The principal patent covering the use of Ganite® for its approved indication,
including Hatch-Waxman extensions, expired in April 2005.
Gentas patent portfolio includes approximately 65 granted patents and 66 pending applications
in the U.S. and foreign countries. We endeavor to seek appropriate U.S. and foreign patent
protection on our oligonucleotide technology.
We have licensed ten U.S. patents relating to Genasense® and its backbone chemistry
that expire between 2008 and 2015. Corresponding patent applications have been filed in three
foreign countries. We also own five U.S. patent applications relating to methods of using
Genasense® expected to expire in 2020 and 2026, with approximately 50 corresponding
foreign patent applications and granted patents.
Most of our products are in an early stage of development, and we may never receive regulatory
approval for these products.
Most of our resources have been dedicated to the research and development of potential
antisense pharmaceutical products such as Genasense®, based upon oligonucleotide
technology. While we have demonstrated the activity of antisense oligonucleotide technology in
model systems in vitro and in animals, Genasense® is our only antisense product to have
been tested in humans. Several of our other technologies that serve as a possible basis for
pharmaceutical products are only in preclinical testing. Results obtained in preclinical studies or
early clinical investigations are not necessarily indicative of results that will be obtained in
extended human clinical trials. Our products may prove to have undesirable and unintended side
effects or other characteristics that may prevent our obtaining FDA or foreign regulatory approval
for any indication. In addition, it is possible that research and discoveries by others will render
our oligonucleotide technology obsolete or noncompetitive.
We will not be able to commercialize our product candidates if our preclinical studies do not
produce successful results or if our clinical trials do not demonstrate safety and efficacy in
humans.
Our success will depend on the success of our currently ongoing clinical trials and subsequent
clinical trials that have not yet begun. It may take several years to complete the clinical trials
of a product, and a failure of one or more of our clinical trials can occur at any stage of
testing. We believe that the development of each of our product candidates involves significant
risks at each stage of testing. If clinical trial difficulties and failures arise, our product
candidates may never be approved for sale or become
39
commercially viable. We do not believe that any of our product candidates have alternative
uses if our current development activities are unsuccessful.
There are a number of difficulties and risks associated with clinical trials. These
difficulties and risks may result in the failure to receive regulatory approval to sell our product
candidates or the inability to commercialize any of our product candidates. The possibility exists
that:
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we may discover that a product candidate does not exhibit the expected therapeutic results
in humans, may cause harmful side effects or have other unexpected characteristics that may
delay or preclude regulatory approval or limit commercial use if approved; |
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the results from early clinical trials may not be statistically significant or predictive
of results that will be obtained from expanded, advanced clinical trials; |
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institutional review boards or regulators, including the FDA, may hold, suspend or
terminate our clinical research or the clinical trials of our product candidates for various
reasons, including noncompliance with regulatory requirements or if, in their opinion, the
participating subjects are being exposed to unacceptable health risks; |
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subjects may drop out of our clinical trials; |
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our preclinical studies or clinical trials may produce negative, inconsistent or
inconclusive results, and we may decide, or regulators may require us, to conduct additional
preclinical studies or clinical trials; and |
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the cost of our clinical trials may be greater than we currently anticipate. |
Between 2004 and 2007, we reported that randomized trials of Genasense® in patients with
myeloma, acute myeloid leukemia, (AML), hormone-refractory prostate cancer, small cell lung cancer
and non small cell lung cancer were not sufficiently positive to warrant further investigation on
the dose-schedules that were examined or with the chemotherapy that was employed in these trials.
Data from these trials have been presented at various scientific meetings.
We cannot assure you that our ongoing preclinical studies and clinical trials will produce
successful results in order to support regulatory approval of Genasense® in any
territory or for any indication. Failure to obtain approval, or a substantial delay in approval of
Genasense® for these or any other indications would have a material adverse effect on
our results of operations and financial condition.
Clinical trials are costly and time consuming and are subject to delays; our business would
suffer if the development process relating to our products were subject to meaningful delays.
Clinical trials are very costly and time-consuming. The length of time required to complete a
clinical study depends upon many factors, including but not limited to the size of the patient
population, the ability of patients to get to the site of the clinical study, the criteria for
determining which patients are eligible to join the study and other issues. Delays in patient
enrollment and other unforeseen developments could delay completion of a clinical study and
increase its costs, which could also delay any eventual commercial sale of the drug that is the
subject of the clinical trial.
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Our commencement and rate of completion of clinical trials also may be delayed by many other
factors, including the following:
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inability to obtain sufficient quantities of materials for use in clinical trials; |
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inability to adequately monitor patient progress after treatment; |
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unforeseen safety issues; |
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the failure of the products to perform well during clinical trials; and |
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government or regulatory delays. |
If we fail to obtain the necessary regulatory approvals, we cannot market and sell our products
in the United States.
The FDA imposes substantial pre-market approval requirements on the introduction of
pharmaceutical products. These requirements involve lengthy and detailed preclinical and clinical
testing and other costly and time-consuming procedures. Satisfaction of these requirements
typically takes several years or more depending upon the type, complexity and novelty of the
product. We cannot apply for FDA approval to market any of our products under development until
preclinical and clinical trials on the product are successfully completed. Several factors could
prevent successful completion or cause significant delays of these trials, including an inability
to enroll the required number of patients or failure to demonstrate adequately that the product is
safe and effective for use in humans. If safety concerns develop, the FDA could stop our trials
before completion. We may not market or sell any product for which we have not obtained regulatory
approval.
We cannot assure you that the FDA will ever approve the use of our products that are under
development. If the patient populations for which our products are approved are not sufficiently
broad, or if approval is accompanied by unanticipated labeling restrictions, the commercial success
of our products could be limited and our business, results of operations and financial condition
could consequently be materially adversely affected.
If the third party manufacturers upon which we rely fail to produce our products in the volumes
that we require on a timely basis, or to comply with stringent regulations applicable to
pharmaceutical drug manufacturers, we may face delays in the commercialization of, or be unable
to meet demand for, our products and may lose potential revenues.
We do not manufacture any of our products or product candidates and we do not plan to develop
any capacity to do so. We have contracted with third-party manufacturers to manufacture
Ganite® and Genasense®. The manufacture of pharmaceutical products requires
significant expertise and capital investment, including the development of advanced manufacturing
techniques and process controls. Manufacturers of pharmaceutical products often encounter
difficulties in production, especially in scaling up initial production. These problems include
difficulties with production costs and yields, quality control and assurance and shortages of
qualified personnel, as well as compliance with strictly enforced federal, state and foreign
regulations. Our third-party manufacturers may not perform as agreed or may terminate their
agreements with us.
In addition to product approval, any facility in which Genasense® is manufactured
or tested for its ability to meet required specifications must be approved by the FDA and/or the
EMEA before it can manufacture Genasense®. Failure of the facility to be approved could
delay the approval of Genasense®.
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We do not currently have alternate manufacturing plans in place. The number of third-party
manufacturers with the expertise, required regulatory approvals and facilities to manufacture bulk
drug substance on a commercial scale is limited, and it would take a significant amount of time to
arrange for alternative manufacturers. If we need to change to other commercial manufacturers, the
FDA and comparable foreign regulators must approve these manufacturers facilities and processes
prior to our use, which would require new testing and compliance inspections, and the new
manufacturers would have to be educated in or independently develop the processes necessary for the
production of our products.
Any of these factors could cause us to delay or suspend clinical trials, regulatory
submissions, required approvals or commercialization of our products or product candidates, entail
higher costs and result in our being unable to effectively commercialize our products. Furthermore,
if our third-party manufacturers fail to deliver the required commercial quantities of bulk drug
substance or finished product on a timely basis and at commercially reasonable prices, and we were
unable to promptly find one or more replacement manufacturers capable of production at a
substantially equivalent cost, in substantially equivalent volume and on a timely basis, we would
likely be unable to meet demand for our products and we would lose potential revenues.
Even if we obtain regulatory approval, we will be subject to ongoing regulation, and any failure
by us or our manufacturers to comply with such regulation could suspend or eliminate our ability
to sell our products.
Ganite®, Genasense® (if it obtains regulatory approval), and any other
product we may develop will be subject to ongoing regulatory oversight, primarily by the FDA.
Failure to comply with post-marketing requirements, such as maintenance by us or by the
manufacturers of our products of current Good Manufacturing Practices as required by the FDA, or
safety surveillance of such products or lack of compliance with other regulations could result in
suspension or limitation of approvals or other enforcement actions. Current Good Manufacturing
Practices are FDA regulations that define the minimum standards that must be met by companies that
manufacture pharmaceuticals and apply to all drugs for human use, including those to be used in
clinical trials, as well as those produced for general sale after approval of an application by the
FDA. These regulations define requirements for personnel, buildings and facilities, equipment,
control of raw materials and packaging components, production and process controls, packaging and
label controls, handling and distribution, laboratory controls and recordkeeping. Furthermore, the
terms of any product candidate approval, including the labeling content and advertising
restrictions, may be so restrictive that they could adversely affect the marketability of our
product candidates. Any such failure to comply or the application of such restrictions could limit
our ability to market our product candidates and may have a material adverse effect on our
business, results of operations and financial condition. Such failures or restrictions may also
prompt regulatory recalls of one or more of our products, which could have material and adverse
effects on our business.
The raw materials for our products are produced by a limited number of suppliers, and our
business could suffer if we cannot obtain needed quantities at acceptable prices and qualities.
The raw materials that we require to manufacture our drugs, particularly oligonucleotides, are
available from only a few suppliers. If these suppliers cease to provide us with the necessary raw
materials or fail to provide us with an adequate supply of materials at an acceptable price and
quality, we could be materially adversely affected.
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If third-party payors do not provide coverage and reimbursement for use of our products, we may
not be able to successfully commercialize our products.
Our ability to commercialize drugs successfully will depend in part on the extent to which
various third-party payors are willing to reimburse patients for the costs of our drugs and related
treatments. These third-party payors include government authorities, private health insurers and
other organizations, such as health maintenance organizations. Third-party payors often challenge
the prices charged for medical products and services. Accordingly, if less costly drugs are
available, third-party payors may not authorize or may limit reimbursement for our drugs, even if
they are safer or more effective than the alternatives. In addition, the federal government and
private insurers have changed and continue to consider ways to change the manner in which health
care products and services are provided and paid for in the United States. In particular, these
third-party payors are increasingly attempting to contain health care costs by limiting both
coverage and the level of reimbursement for new therapeutic products. In the future, it is possible
that the government may institute price controls and further limits on Medicare and Medicaid
spending. These controls and limits could affect the payments we collect from sales of our
products. Internationally, medical reimbursement systems vary significantly, with some countries
requiring application for, and approval of, government or third-party reimbursement. In addition,
some medical centers in foreign countries have fixed budgets, regardless of levels of patient care.
Even if we succeed in bringing therapeutic products to market, uncertainties regarding future
health care policy, legislation and regulation, as well as private market practices, could affect
our ability to sell our products in quantities, or at prices, that will enable us to achieve
profitability.
Our business exposes us to potential product liability that may have a negative effect on our
financial performance and our business generally.
The administration of drugs to humans, whether in clinical trials or commercially, exposes us
to potential product and professional liability risks, which are inherent in the testing,
production, marketing and sale of human therapeutic products. Product liability claims can be
expensive to defend and may result in large judgments or settlements against us, which could have a
negative effect on our financial performance and materially and adversely affect our business. We
maintain product liability insurance (subject to various deductibles), but our insurance coverage
may not be sufficient to cover claims. Furthermore, we cannot be certain that we will always be
able to maintain or increase our insurance coverage at an affordable price. Even if a product
liability claim is not successful, the adverse publicity and time and expense of defending such a
claim may interfere with or adversely affect our business and financial performance.
We may incura variety of costs to engage in future acquisitions of companies, products or
technologies, and the anticipated benefits of those acquisitions may never be realized.
As a part of our business strategy, we may make acquisitions of, or significant investments
in, complementary companies, products or technologies, although no significant acquisition or
investments are currently pending. Any future acquisitions would be accompanied by risks such as:
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difficulties in assimilating the operations and personnel of acquired companies; |
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diversion of our managements attention from ongoing business concerns; |
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our potential inability to maximize our financial and strategic position through the
successful incorporation of acquired technology and rights into our products and services; |
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additional expense associated with amortization of acquired assets; |
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maintenance of uniform standards, controls, procedures and policies; and |
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impairment of existing relationships with employees, suppliers and customers as a
result of the integration of new management personnel. |
43
We cannot guarantee that we will be able to successfully integrate any business, products,
technologies or personnel that we might acquire in the future, and our failure to do so could harm
our business.
We face substantial competition from other companies and research institutions that are
developing similar products, and we may not be able to compete successfully.
In many cases, our products under development will be competing with existing therapies for
market share. In addition, a number of companies are pursuing the development of antisense
technology and controlled-release formulation technology and the development of pharmaceuticals
utilizing such technologies. We compete with fully integrated pharmaceutical companies that have
more substantial experience, financial and other resources and superior expertise in research and
development, manufacturing, testing, obtaining regulatory approvals, marketing and distribution.
Smaller companies may also prove to be significant competitors, particularly through their
collaborative arrangements with large pharmaceutical companies or academic institutions.
Furthermore, academic institutions, governmental agencies and other public and private research
organizations have conducted and will continue to conduct research, seek patent protection and
establish arrangements for commercializing products. Such products may compete directly with any
products that may be offered by us.
Our competition will be determined in part by the potential indications for which our products
are developed and ultimately approved by regulatory authorities. For certain of our potential
products, an important factor in competition may be the timing of market introduction of our or our
competitors products. Accordingly, the relative speed with which we can develop products, complete
the clinical trials and approval processes and supply commercial quantities of the products to the
market are expected to be important competitive factors. We expect that competition among products
approved for sale will be based, among other things, on product efficacy, safety, reliability,
availability, price, patent position and sales, marketing and distribution capabilities. The
development by others of new treatment methods could render our products under development
non-competitive or obsolete.
Our competitive position also depends upon our ability to attract and retain qualified
personnel, obtain patent protection or otherwise develop proprietary products or processes and
secure sufficient capital resources for the often-substantial period between technological
conception and commercial sales. We cannot assure you that we will be successful in this regard.
We are dependent on our key executives and scientists, and the loss of key personnel or the
failure to attract additional qualified personnel could harm our business.
Our business is highly dependent on our key executives and scientific staff. The loss of key
personnel or the failure to recruit necessary additional or replacement personnel will likely
impede the achievement of our development objectives. There is intense competition for qualified
personnel in the pharmaceutical and biotechnology industries, and there can be no assurances that
we will be able to attract and retain the qualified personnel necessary for the development of our
business.
44
Risks Related to Outstanding Litigation
The outcome of and costs relating to the pending stockholder class action and stockholder
derivative actions are uncertain.
In 2004, numerous complaints were filed in the United States District Court for the District
of New Jersey, or the Court, against us and certain of our principal officers on behalf of
purported classes of the Companys stockholders who purchased its securities during several class
periods. The complaints were consolidated into a single action and alleged that the Company and
certain of its principal officers violated the federal securities laws by issuing materially false
and misleading statements regarding Genasense® for the treatment of malignant melanoma
that had the effect of artificially inflating the market price of the Companys securities. The
stockholder class action complaint sought monetary damages in an unspecified amount and recovery of
plaintiffs costs and attorneys fees. We reached an agreement with plaintiffs to settle the class
action litigation in consideration for the issuance of 2.0 million shares of common stock of the
Company (adjusted for any subsequent event that results in a change in the number of shares
outstanding as of January 31, 2007) and $18.0 million in cash for the benefit of plaintiffs and the
stockholder class. The cash portion of the proposed settlement will be covered by our insurance
carriers. Effective June 25, 2007, we and the plaintiffs executed a written Stipulation and
Agreement of Settlement, which was filed with the Court on
August 13, 2007, seeking preliminary
approval. The unopposed Motion for Preliminary Approval of Settlement was granted on October 30,
2007, and the Court issued final approval of the Settlement at the Settlement Fairness Hearing on
March 3, 2008. An order approving the settlement was issued on May 27, 2008 and the settlement
became final on June 27, 2008.
The settlement and potential settlement did not constitute an admission of guilt or liability.
In February 2007, a complaint against us was filed in the Superior Court of New Jersey by
Howard H. Fingert, M.D., a former employee of Genta. The complaint alleges, among other things,
breach of contract as to our stock option plan and as to a consulting agreement allegedly entered
into by us and Dr. Fingert subsequent to termination of Dr. Fingerts employment with us, breach of
implied covenant of good faith and fair dealing with respect to our stock option plan and the
alleged consulting agreement, promissory estoppel with respect to the exercise of stock options and
provision of consulting services after termination of employment, and fraud and negligent
misrepresentation with respect to exercise of stock options and provision of consulting services
after termination of employment. The complaint seeks monetary damages, including punitive and
consequential damages. We filed an answer to the complaint on May 29, 2007, and on August 8, 2007,
filed a request for production of documents. On January 4, 2008, the Court dismissed the complaint
without prejudice due to Dr. Fingerts failure to produce the requested discovery. Dr. Fingert
filed a motion dated March 24, 2008 to reinstate the complaint, which was granted by the Court on
April 11, 2008 at which time the Court adopted a discovery schedule that concludes in December
2008. We deny the allegations in the complaint and intend to vigorously defend this lawsuit.
In November 2007, a complaint against us was filed in the United States District Court for the
District of New Jersey by Ridge Clearing & Outsourcing Solutions, Inc. The complaint alleges, among
other things, that we caused or contributed to losses suffered by one of our stockholders, which
have been incurred by Ridge. Our Answer and Affirmative Defenses were filed on February 27, 2008
to respond to the complaint. We deny the allegations in the complaint and intend to vigorously
defend this lawsuit.
45
Risks Related to Our Common Stock
Provisions in our restated certificate of incorporation and bylaws and Delaware law may
discourage a takeover and prevent our stockholders from receiving a premium for their shares.
Provisions in our restated certificate of incorporation and bylaws may discourage third
parties from seeking to obtain control of us and, therefore, could prevent our stockholders from
receiving a premium for their shares. Our restated certificate of incorporation gives our Board of
Directors the power to issue shares of preferred stock without approval of the holders of common
stock. Any preferred stock that is issued in the future could have voting rights, including voting
rights that could be superior to that of our common stock. The affirmative vote of 66 2/3% of our
voting stock is required to approve certain transactions and to take certain stockholder actions,
including the amendment of certain provisions of our certificate of incorporation. Our bylaws
contain provisions that regulate how stockholders may present proposals or nominate directors for
election at annual meetings of stockholders.
In addition, we are subject to Section 203 of the Delaware General Corporation Law, which
contains restrictions on stockholder action to acquire control of us.
In September 2005, our Board of Directors approved a Stockholder Rights Plan and declared a
dividend of one preferred stock purchase right, which we refer to as a Right, for each share of our
common stock held of record as of the close of business on September 27, 2005. In addition, Rights
shall be issued in respect of all shares of common stock issued after such date. The Rights contain
provisions to protect stockholders in the event of an unsolicited attempt to acquire us, including
an accumulation of shares in the open market, a partial or two-tier tender offer that does not
treat all stockholders equally and other activities that the Board believes are not in the best
interests of stockholders. The Rights may discourage a takeover and prevent our stockholders from
receiving a premium for their shares.
We have not paid, and do not expect to pay in the future, cash dividends on our common stock.
We have never paid cash dividends on our common stock and do not anticipate paying any such
dividends in the foreseeable future. We currently intend to retain our earnings, if any, for the
development of our business.
Our stock price is volatile.
The market price of our common stock, like that of the common stock of many other
biopharmaceutical companies, has been and likely will continue to be highly volatile. Factors that
could have a significant impact on the future price of our common stock include but are not limited
to:
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the results of preclinical studies and clinical trials by us or our competitors; |
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announcements of technological innovations or new therapeutic products by us or our
competitors; |
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government regulation; |
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developments in patent or other proprietary rights by us or our respective competitors,
including litigation; |
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fluctuations in our operating results; and |
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market conditions for biopharmaceutical stocks in general. |
46
At June 30,2008, we had 36.7 million shares of common stock outstanding, 43.4 million
additional shares reserved for the conversion of convertible preferred stock and the exercise of
outstanding options and warrants. Future sales of shares of our common stock by existing
stockholders, holders of preferred stock who might convert such preferred stock into common stock
and option and warrant holders who may exercise their options and warrants to purchase common stock
also could adversely affect the market price of our common stock. Moreover, the perception that
sales of substantial amounts of our common stock might occur could adversely affect the market
price of our common stock.
At our Annual Meeting of Stockholders held on July 11, 2007, our stockholders authorized our
Board of Directors to effect a reverse stock split of all outstanding shares of common stock, and
the Board of Directors subsequently approved the implementation of a reverse stock split at a ratio
of one for six shares. On July 12, 2007, we filed a Certificate of Amendment to our Restated
Certificate of Incorporation, as amended, with the Delaware Secretary of State to effect the
reverse stock split. As of July 12, 2007, the effective date of the reverse stock split, every six
shares of old common stock were converted into one new share of common stock. Upon the open of
trading on July 13, 2007, the new shares of common stock began trading on the NASDAQ Global
Market on a split-adjusted basis. As a result of the 1-for-6 reverse stock split, shares of our
common stock outstanding were reduced from 183.7 million shares on a pre-split basis to 30.6
million shares on a post-split basis, or 83%. The resulting decrease in the number of shares of our
common stock outstanding could potentially adversely affect the liquidity of our common stock,
especially in the case of larger block trades.
Effective May 7, 2008, we moved the trading of our common stock from The NASDAQ Capital
Markets to the OTC Bulletin Board maintained by FINRA (formerly, the NASD). This action was taken
pursuant to receipt of notification from the NASDAQ Listing Qualifications Panel that we had failed
to demonstrate our ability to sustain compliance with the $2.5 million minimum stockholders equity
requirement for continued listing on The NASDAQ Capital Markets. On July 10, 2008, we received
notification from The NASDAQ Capital Market that The NASDAQ Capital Market had determined to remove
our common stock from listing on such exchange. The delisting was effective at the opening of the
trading session on July 21, 2008.
If our convertible noteholders convert their notes into shares of our common stock, our
stockholders may be diluted.
On June 5, 2008, we entered into a securities purchase agreement with certain institutional
and accredited investors, to place up to $40 million of senior secured convertible notes, referred
to herein as the notes, with such investors. On June 9, 2008, we placed $20 million of such notes
in the initial closing. The notes bear interest at an annual rate of 15% per annum payable at
quarterly intervals in stock or cash at the Companys option, and will be convertible into shares
of the Companys common stock at a conversion rate of 100,000 shares of common stock for every
$1,000 of principal; provided, however, at no time may the holder of a note convert such note if
such conversion would cause the holder to beneficially own more than 4.999% of the then outstanding
shares of common stock of the Company. Until June 9, 2009, the holders of the notes have the right,
but not the obligation, to purchase in whole or in part up to an additional $20 million of notes.
We have the right to force conversion of the notes in whole or in part if the closing bid price of
our common stock exceeds $0.50 for a period of 20 consecutive trading days. Certain members of our
senior management participated in the initial closing. Pursuant to the general security agreement,
the notes are secured by a first lien on all of our assets, subject to certain exceptions set forth
in such security agreement. The notes include certain events of default, including a requirement
that we obtain stockholder approval within a specified period of time to amend our certificate of
incorporation to authorize additional shares of common stock.
The conversion of some or all of our notes will dilute the ownership interests of existing
stockholders. Any sales in the public market of the common stock issuable upon conversion of the
notes could adversely affect prevailing market prices of our common stock. In addition, the
existence of the notes may encourage short selling by market participants because the conversion of
the notes could depress the price of our common stock.
47
If holders of our notes elect to convert their notes and sell material amounts of our common
stock in the market, such sales could cause the price of our common stock to decline, and such
downward pressure on the price of our common stock may encourage short selling of our common stock
by holders of our notes or others. To the extent that holders of our notes elect to convert the
notes into shares of our common stock and sell material amounts of those shares in the market, our
stock price may decrease as a result of the additional amount of shares available on the market.
The subsequent sales of these shares could encourage short sales by holders of notes and others,
placing further downward pressure on our stock price.
If there is significant downward pressure on the price of our common stock, it may encourage
holders of notes or others to sell shares by means of short sales to the extent permitted under the
U.S. securities laws. Short sales involve the sale by a holder of notes, usually with a future
delivery date, of common stock the seller does not own. Covered short sales are sales made in an
amount not greater than the number of shares subject to the short sellers right to acquire common
stock, such as upon conversion of notes. A holder of notes may close out any covered short
position by converting its notes or purchasing shares in the open market. In determining the
source of shares to close out the covered short position, a holder of notes will likely consider,
among other things, the price of common stock available for purchase in the open market as compared
to the conversion price of the notes. The existence of a significant number of short sales
generally causes the price of common stock to decline, in part because it indicates that a number
of market participants are taking a position that will be profitable only if the price of the
common stock declines.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
No matters were submitted to a vote of security holders in the quarter ended June 30, 2008.
Item 5. Other Information
None.
48
Item 6. Exhibits.
(a) Exhibits
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Exhibit |
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Number |
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Description of Document |
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4.1
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Form of Senior Secured Convertible Promissory Note
(Incorporated by reference to Exhibit 4.1 of the Companys
Current Report on Form 8-K, as filed with the SEC on June
10, 2008). |
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4.2 |
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Common Stock Purchase Warrant, dated June 9, 2008 (filed herewith). |
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10.1
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Supply Agreement, dated May 1, 2008, between the Company
and Avecia Biotechnology (filed herewith).* |
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10.2
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Amendment to the Lease Agreement, dated May 27, 2008,
between the Company and The Connell Company (filed
herewith). |
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10.3
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Securities Purchase Agreement, dated June 5, 2008, by and
among the Company and certain accredited investors set
forth therein (Incorporated by reference to Exhibit 10.1 of
the Companys Current Report on Form 8-K, as filed with the
SEC on June 10, 2008). |
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10.4
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General Security Agreement, dated June 9, 2008, by and
among the Company, certain additional grantors as set forth
therein and Tang Capital Partners, L.P. as agent
(Incorporated by reference to Exhibit 10.2 of the Companys
Current Report on Form 8-K, as filed with the SEC on June
10, 2008). |
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31.1
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Certification by Chief Executive Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002 (filed
herewith). |
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31.2
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Certification by Vice President, Finance pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002 (filed
herewith). |
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32.1
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Certification by Chief Executive Officer pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002 (furnished herewith). |
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32.2
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Certification by Vice President, Finance pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002 (furnished herewith). |
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* |
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Portions of this exhibit have been omitted under a request for confidential treatment and filed
separately with the Securities and Exchange Commission. |
49
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized
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Genta Incorporated |
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Date: August 7, 2008 |
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/s/ RAYMOND P. WARRELL, JR., M.D. |
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Raymond P. Warrell, Jr., M.D. |
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Chairman and Chief Executive Officer |
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(principal executive officer) |
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Date: August 7, 2008 |
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/s/ GARY SIEGEL |
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Gary Siegel |
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Vice President, Finance |
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(principal financial and accounting officer) |
50
Exhibit Index
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Exhibit |
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Number |
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Description of Document |
4.1
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Form of Senior Secured Convertible Promissory Note
(Incorporated by reference to Exhibit 4.1 of the Companys
Current Report on Form 8-K, as filed with the SEC on June
10, 2008). |
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4.2 |
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Common Stock Purchase Warrant, dated June 9, 2008 (filed herewith). |
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10.1
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Supply Agreement, dated May 1, 2008, between the Company
and Avecia Biotechnology (filed herewith) (filed
herewith).* |
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10.2
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Amendment to the Lease Agreement, dated May 27, 2008,
between the Company and The Connell Company (filed
herewith). |
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10.3
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Securities Purchase Agreement, dated June 5, 2008, by and
among the Company and certain accredited investors set
forth therein (Incorporated by reference to Exhibit 10.1 of
the Companys Current Report on Form 8-K, as filed with the
SEC on June 10, 2008). |
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10.4
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General Security Agreement, dated June 9, 2008, by and
among the Company, certain additional grantors as set forth
therein and Tang Capital Partners, L.P. as agent
(Incorporated by reference to Exhibit 10.2 of the Companys
Current Report on Form 8-K, as filed with the SEC on June
10, 2008). |
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31.1
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Certification by Chief Executive Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002 (filed
herewith). |
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31.2
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Certification by Vice President, Finance pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002 (filed
herewith). |
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32.1
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Certification by Chief Executive Officer pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002 (furnished herewith). |
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32.2
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Certification by Vice President, Finance pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002 (furnished herewith). |
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* |
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Portions of this exhibit have been omitted under a request for confidential treatment and filed
separately with the Securities and Exchange Commission. |
51