Filed by Bowne Pure Compliance
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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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
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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 001-33043
ImaRx Therapeutics, Inc.
(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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86-0974730
(I.R.S. Employer
Identification No.) |
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1730 East River Road, Suite 200, Tucson, AZ
(Address of Principal Executive Offices)
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85718-5893
(Zip Code) |
(520) 770-1259
(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 at least 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 o
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Smaller reporting company þ |
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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 Exchange Act).
YES o NO þ
The number of shares outstanding of each of the issuers classes of common stock, as of the
latest practicable date is as follows:
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Class
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Outstanding at August 12, 2008 |
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Common Stock $0.0001 par value
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10,165,733 |
PART 1. FINANCIAL INFORMATION
Item 1. Consolidated Financial Statements.
ImaRx Therapeutics, Inc.
Consolidated Balance Sheets
(in thousands, except per share data)
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June 30 |
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December 31 |
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2008 |
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2007 |
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(Unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
2,146 |
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$ |
12,861 |
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Restricted cash |
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388 |
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Accounts receivable, net |
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28 |
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349 |
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Inventory |
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2,500 |
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11,138 |
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Inventory subject to return |
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1,309 |
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2,560 |
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Assets held for sale |
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279 |
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Prepaid expenses and other |
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201 |
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589 |
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Total current assets |
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6,463 |
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27,885 |
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Long-term assets: |
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Property and equipment, net |
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112 |
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1,170 |
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Intangible assets, net |
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1,633 |
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Other |
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19 |
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Total assets |
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$ |
6,575 |
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$ |
30,707 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,459 |
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$ |
1,277 |
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Accrued expenses |
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591 |
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837 |
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Accrued chargebacks and administrative fees |
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1,069 |
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1,317 |
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Deferred revenue |
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2,640 |
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5,373 |
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Notes payable and accrued interest |
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11,698 |
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Other |
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247 |
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Total current liabilities |
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6,006 |
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20,502 |
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Stockholders equity: |
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Common stock, $.0001 par: |
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100,000,000 shares authorized,
10,165,733 shares issued and
outstanding at June 30, 2008
(unaudited) and 10,046,683 shares
issued and outstanding at December 31,
2007 |
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1 |
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1 |
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Additional paid-in capital |
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91,550 |
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91,386 |
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Accumulated deficit |
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(90,982 |
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(81,182 |
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Total stockholders equity |
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569 |
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10,205 |
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Total liabilities and stockholders equity |
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$ |
6,575 |
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$ |
30,707 |
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See accompanying notes.
3
ImaRx Therapeutics, Inc.
Consolidated Statements of Operations
(in thousands, except per share data)
(Unaudited)
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Three Months Ended |
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Six Months Ended |
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June 30 |
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June 30 |
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2008 |
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2007 |
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2008 |
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2007 |
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Revenues: |
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Product sales, net |
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$ |
2,040 |
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$ |
1,992 |
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$ |
3,889 |
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$ |
3,078 |
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Research and development |
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106 |
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161 |
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201 |
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283 |
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Total revenue |
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2,146 |
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2,153 |
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4,090 |
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3,361 |
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Costs and expenses: |
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Cost of product sales |
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925 |
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959 |
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1,759 |
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1,420 |
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Research and development |
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1,033 |
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1,606 |
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2,600 |
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3,143 |
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General and administrative |
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2,994 |
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1,158 |
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4,988 |
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2,582 |
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Asset Impairment |
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9,978 |
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9,978 |
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Total cost and expenses |
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14,930 |
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3,723 |
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19,325 |
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7,145 |
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Operating loss |
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(12,784 |
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(1,570 |
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(15,235 |
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(3,784 |
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Interest and other income, net |
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(58 |
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89 |
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36 |
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130 |
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Interest expense |
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(30 |
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(225 |
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(203 |
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(450 |
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Gain on extinguishment of debt |
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5,602 |
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219 |
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5,602 |
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219 |
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Net loss |
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(7,270 |
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(1,487 |
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(9,800 |
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(3,885 |
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Accretion of dividends on preferred stock |
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(434 |
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(867 |
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Net loss attributable to common stockholders |
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$ |
(7,270 |
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$ |
(1,921 |
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$ |
(9,800 |
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$ |
(4,752 |
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Basic and diluted loss per common share: |
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Net loss attributable to common shareholders |
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$ |
(0.72 |
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$ |
(0.74 |
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$ |
(0.97 |
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$ |
(1.82 |
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Weighted average common shares outstanding: |
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Basic and diluted |
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10,087,238 |
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2,606,019 |
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10,067,072 |
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2,605,968 |
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See accompanying notes.
4
ImaRx Therapeutics, Inc.
Consolidated Statements of Cash Flows
(in thousands)
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Six Months Ended June 30 |
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2008 |
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2007 |
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(unaudited) |
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Operating activities |
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Net loss |
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$ |
(9,800 |
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$ |
(3,885 |
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Adjustments to reconcile net loss to net cash (used in) provided by operating activities: |
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Depreciation |
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448 |
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649 |
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Stock-based compensation |
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165 |
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147 |
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Gain on extinguishments of debt |
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(5,602 |
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(219 |
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Loss on sale of property and equipment |
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198 |
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Asset impairment |
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9,978 |
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Changes in operating assets and liabilities: |
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Inventory |
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437 |
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4,380 |
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Inventory subject to return |
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1,251 |
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(3,764 |
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Accounts receivable |
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321 |
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382 |
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Prepaid expenses and other |
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407 |
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183 |
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Accounts payable |
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181 |
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15 |
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Accrued expenses and other liabilities |
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(45 |
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2,969 |
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Deferred revenue |
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(2,732 |
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7,234 |
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Net cash (used in) provided by operating activities |
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(4,793 |
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8,091 |
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Investing activities |
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Purchase of property and equipment |
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(11 |
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(324 |
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Net cash used in investing activities |
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(11 |
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(324 |
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Financing activities |
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Deferred financing costs |
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(1,004 |
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Payment on note payable |
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(6,299 |
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Change in restricted cash |
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388 |
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(4,421 |
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Net cash used in financing activities |
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(5,911 |
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(5,425 |
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Net increase (decrease) in cash and cash equivalents |
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(10,715 |
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2,342 |
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Cash and cash equivalents at the beginning of the period |
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12,861 |
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4,256 |
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Cash and cash equivalents at the end of the period |
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$ |
2,146 |
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$ |
6,598 |
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Supplemental Schedule of Noncash Investing and Financing Activities: |
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Accretion of undeclared dividends on Series A/D Redeemable Convertible Preferred Stock |
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$ |
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$ |
867 |
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See accompanying notes.
5
ImaRx Therapeutics, Inc.
Notes to Consolidated Financial Statements
June 30, 2008
(Unaudited)
1. The Company and Significant Accounting Policies
The Company
We are a biopharmaceutical company with one commercially available product, urokinase, and a
research and development program centered on our proprietary microbubble technology together with
ultrasound.
Urokinase is a thrombolytic drug formerly marketed under the brand name Abbokinase® and is
currently being re-branded as Kinlytic. Urokinase is approved by the U.S. Food and Drug
Administration, or FDA, for the treatment of acute massive pulmonary embolism, or blood clots in
the lungs.
Our research and development efforts have focused on the development of therapies for stroke
and other vascular disorders, using our proprietary microbubble technology together with
ultrasound. Our lead program, SonoLysis, involves the administration of our proprietary MRX-801
microbubbles and ultrasound to break up blood clots and restore blood flow to oxygen deprived
tissues.
On June 11, 2008, we announced a restructuring that included a significant workforce
reduction. Company management and our board of directors determined that the restructuring was
necessary in light of the termination of our agreement with Microbix Biosystems relating to the
sale of our urokinase inventory and related assets, notification from the FDA that additional
testing would be required for approval of our urokinase stability testing program and release of
labeled vials of urokinase, our cash position and the lack of new capital resources to fund our
commercial and development programs. As part of the restructuring,
all of our employees other than Bradford Zakes, our president and chief executive officer, and one
additional employee were terminated. We paid a retention bonus to each of the remaining employees
and entered into agreements with each of them to reimburse us a portion of the retention bonus
should they voluntarily leave the employ of the Company prior to
certain agreed upon dates.
In furtherance of the June 2008 restructuring we are now exploring strategic alternatives for
our commercial urokinase assets, clinical-stage SonoLysis program and other company assets, which
may involve the disposition of some or all of these assets. Certain of our former key employees
entered into consulting agreements with us in order to assist us in exploring these strategic
alternatives.
Basis of Presentation
The accompanying interim consolidated financial statements have been prepared in conformity
with U.S. generally accepted accounting principles, consistent in all material respects with those
applied in our Annual Report on Form 10-K/A for the year ended December 31, 2007. The financial
information is unaudited, but reflects all adjustments, consisting only of normal recurring
adjustments and accruals, which are, in the opinion of management, necessary to reflect a fair
statement of results for the interim periods presented. Interim results are not necessarily
indicative of results for a full year. The information included in this Form 10-Q should be read
in conjunction with the Annual Report on Form 10-K/A for the year ended December 31, 2007.
As a result of the events leading to our June 2008 restructuring, we have new risks and
challenges facing us. Since 2006, one of our primary sources of cash has been the sale of our
urokinase product. Due to the FDAs requirement of additional testing as a prerequisite to the
release of labeled lots, and the uncertainty as to the outcome of any such testing, our actual
proceeds from sales of urokinase may fall short of previous projections. We do not currently have
any other significant source of cash. One of the strategic alternatives being considered is the
sale of all of the commercial urokinase assets to an unrelated party. If we are unable to achieve
such a sale or to secure the release of the labeled vials of urokinase from the FDA in a timely
manner or at all, we may not have sufficient capital resources to support operations and continue
as a going concern.
Our ability to continue as a going concern depends on the successful future sales of our urokinase
product and the commercialization or licensing of our development stage technologies. We have had
recurring losses, which have resulted in an accumulated deficit of
$91.0 million at June 30, 2008.
These conditions, among others, raise substantial doubt about our ability to continue as a going
concern. The financial statements include adjustments to reduce the value of the urokinase assets
and certain other assets to market
value, but do not include any other adjustments relating to the recoverability and classification
of recorded assets, or the amounts and classification of liabilities that might be necessary in the
event we cannot acquire additional financing or execute the strategic alternatives being
considered.
6
Inventory and Inventory Subject to Return
Inventory is comprised of finished goods and is stated at the lower of cost or market value.
Inventory subject to return is comprised of finished goods, stated at the lower of cost or market
value, and represents the amount of inventory that has been sold to wholesale distributors. When
product is sold by the wholesale distributor to a hospital or other health care provider, a
reduction in this account occurs and cost of sales is recorded.
Abbokinase (urokinase), rebranded under the name Kinlytic, is our only commercially available
FDA approved product. Abbokinase is a thrombolytic or clot-dissolving agent approved for the
treatment of acute massive pulmonary embolism, or blood clots in the lungs. When we acquired
urokinase from Abbott Laboratories, we received 111,000 vials that we determined could be sold and
we assigned a portion of the purchase price to these vials. We estimated that the remainder of the
vials that we acquired would not be sold and, consequently, these vials are carried with no book
value assigned. We periodically review the composition of inventory in order to identify obsolete,
slow-moving or otherwise un-saleable inventory. We will write down inventory for estimated obsolete
or un-saleable inventory in an amount equal to the difference between the cost of the inventory and
the estimated market value based upon assumptions about future demand and market conditions.
We have an ongoing stability and release testing program to support expiration date extensions
for the unlabeled vials. Under our agreement with Abbott Laboratories we were required to transfer
the stability and release testing program from Abbott to another laboratory. The transfer of the
stability and release testing program to the laboratory of a contract research organization, or
CRO, was completed and we have submitted to the FDA a Changes Being Effected in 30 days
supplemental new drug application, or CBE-30, requesting approval for the transfer. Under the
CBE-30, if the FDA does not object within 30 days of receiving the supplement and the supplement is
filed, the requested change(s) may take effect. However, even if the 30 day period lapses without
objection, under the Prescription Drug User Fee Act or PDUFA, the FDA must still take formal action
to approve or not approve the application within 180 days of receipt of the submission. The 30 day
period passed without an objection and our application was filed. We subsequently submitted to the
FDA lot release requests for inventory labeled with the new expiration dating. In the first quarter
of 2008 the FDA approved the lot release requests. Subsequently, we
received formal notice from the
FDA that before our application may be approved, we must first revise our stability and release
program to include additional assays that detect modified forms of the active pharmaceutical
ingredient or API. The FDA further indicated that the lots it released during the first quarter of
2008 will need to be tested for sub-visible particulates prior to distribution to the general
public. The FDAs newly required tests are part of an FDA initiative to align stability programs
for products, such as urokinase, with extended expiration dating to current FDA standards.
In
light of the FDA action, we evaluated the carrying value of the inventory and determined that the value of the inventory as of June 30, 2008 had been impaired and as a result we reduced the
carrying value of the inventory by $8.2 million, to its market value. As of June 30, 2008, 34% of
the vials in inventory held by our wholesale distributors, or $1.3 million in inventory value will
expire at various times up to September 2009. Once labeled inventory expires it cannot be relabeled
and sold. The urokinase inventory will not be saleable unless and until our stability testing program has
been approved by the FDA and we have data supporting further expiration dating for the inventory.
Costs related to shipping and handling are charged to general and administrative expense as
incurred.
Revenue Recognition
Revenue from product sales is recognized pursuant to SEC Staff Bulletin No. 104 (SAB 104),
Revenue Recognition in Financial Statements. Accordingly, revenue is recognized when all four of
the following criteria are met: (i) persuasive evidence that an arrangement exists; (ii) delivery
of the products has occurred; (iii) the selling price is both fixed and determinable; and (iv)
collectability is reasonably assured. We apply SFAS No. 48, Revenue Recognition When the Right of
Return Exists, which amongst other criteria, requires that future returns be reasonably estimated
in order to recognize revenue. The amount of future returns is uncertain due to the insufficiency
of returns history data. Due to the uncertainty of returns from our wholesale distributors, we are
accounting for product shipments to wholesale distributors using a deferred revenue recognition
model.
7
Under this model, we do not recognize revenue upon product shipment to wholesale distributors; therefore, recognition of
revenue is deferred until the product is sold by the wholesale distributor to the end user. Our
returns policy allows end users to return product within 12 months after expiration, but current
practice by wholesale distributors and end users is generally a just in time purchasing
methodology, meaning that the product is purchased by the end user on an as-needed basis, typically
on a daily or weekly basis. Although the product was previously marketed by Abbott Laboratories, we
were unable to obtain historical returns data for the product from Abbott Laboratories at the time
of our acquisition of Abbokinase. Based on input from our wholesale distributors, current
purchasing practices and the estimated amount of product in the channel, we anticipate immaterial
product returns from end users.
Our customers consist primarily of large established pharmaceutical wholesale distributors who
sell directly to hospitals and other healthcare providers. Provisions for product returns and
exchanges, sales discounts, chargebacks, managed care and Medicaid rebates and other adjustments
are established as a reduction of product sales revenues at the time such revenues are recognized.
These deductions from gross revenue are established by management as its best estimate at the time
of sale adjusted to reflect known changes in the factors that impact such reserves.
AmerisourceBergen
accounted for 25%, Cardinal accounted for 41% and McKesson Corporation
accounted for 31% of our total gross product revenues for the three months ended June 30, 2008.
AmerisourceBergen accounted for 26%, Cardinal accounted for 36% and McKesson Corporation accounted
for 30% of our total gross product revenues for the three months ended June 30, 2007.
AmerisourceBergen accounted for 27%, Cardinal accounted for 41% and McKesson Corporation
accounted for 30% of our total gross product revenues for the six months ended June 30, 2008.
AmerisourceBergen accounted for 39%, Cardinal accounted for 34% and McKesson Corporation accounted
for 22% of our total gross product revenues for the six months ended June 30, 2007.
2. Recently Issued Accounting Pronouncements
In December 2007, the FASB issued SFAS No. 141 (revised 2007) (SFAS 141R), Business
Combinations and SFAS No. 160 (SFAS 160), Noncontrolling Interests in Consolidated Financial
Statements, an amendment of Accounting Research Bulletin No. 51. SFAS 141R will change how business
acquisitions are accounted for and will impact financial statements both on the acquisition date
and in subsequent periods. SFAS 160 will change the accounting and reporting for minority
interests, which will be recharacterized as noncontrolling interests and classified as a component
of equity. SFAS 141R and SFAS 160 are effective beginning in the first fiscal period ending after
December 15, 2008. Early adoption is not permitted. We do not believe the adoption of these new
standards, SFAS 141R and SFAS 160, will have an impact on our consolidated financial statements.
3. Impact of Recently Issued Accounting Standards
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157). SFAS
157 provides guidance for using fair value to measure assets and liabilities. It also responds to
investors requests for expanded information about the extent to which a company measures assets
and liabilities at fair value, the information used to measure fair value, and the effect of fair
value measurements on earnings. SFAS 157 applies whenever other standards require (or permit)
assets or liabilities to be measured at fair value, and does not expand the use of fair value in
any new circumstances. SFAS 157 is effective for financial statements issued for fiscal years
beginning after November 15, 2007, and was adopted by us in the first quarter of 2008. The adoption
of SFAS 157 did not have a material impact on our consolidated results of operations and financial
condition.
In February 2007, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards (SFAS) No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities-including an amendment of FASB Statement No. 115 (SFAS 159). SFAS 159
expands the use of fair value accounting but does not affect existing standards which require
assets or liabilities to be carried at fair value. Under SFAS 159, a company may elect to use fair
value to measure accounts and loans receivable, available-for-sale and held-to-maturity securities,
equity method investments, accounts payable, guarantees and issued debt. Other eligible items
include firm commitments for financial instruments that otherwise would not be recognized at
inception and non-cash warranty obligations where a warrantor is permitted to pay a third party to
provide the warranty goods or services. If the use of fair value is elected, any upfront costs and
fees related to the item must be recognized in earnings and cannot be deferred, e.g., debt issue
costs. The fair value election is irrevocable and generally made on an instrument-by-instrument
basis, even if a company has similar instruments that it elects not to measure based on fair value.
At the adoption date, unrealized gains and losses on existing items for which fair value has been
elected are reported as a cumulative adjustment to beginning retained earnings. Subsequent to the
adoption of SFAS 159, changes in fair value are recognized in earnings. SFAS 159 is effective for
fiscal years beginning after November 15, 2007, and was adopted by us in the first quarter of 2008.
The adoption of SFAS 159 did not have a material impact on
our consolidated results of operations and financial condition as the fair value option was
not elected for any of our financial assets or financial liabilities.
8
In June 2007, the FASB ratified EITF Issue No. 07-3 (EITF No. 07-3), Accounting for
Non-Refundable Advance Payments for Goods or Services to Be Used in Future Research and Development
Activities, which requires nonrefundable advance payments for goods and services that will be used
or rendered for future research and development activities to be deferred and capitalized. These
amounts will be recognized as expense in the period that the related goods are delivered or the
related services are performed. EITF No. 07-3 is effective for fiscal years beginning after
December 15, 2007. We adopted the provisions of EITF No. 07-3 in the first quarter of 2008 and the
adoption of EITF No. 07-3 did not have a material impact on our consolidated results of operations
and financial condition.
4. Asset Acquisition
In April 2006, we acquired from Abbott Laboratories the assets related to Abbokinase,
including the remaining inventory of finished product, all regulatory and clinical documentation,
validated cell lines, and intellectual property rights, including trade secrets and know-how
relating to the manufacture of urokinase using the tissue culture method, for a total purchase
price of $20.0 million. The purchase price was comprised of $5.0 million in cash and a $15.0
million secured promissory note. The original due date of the note was December 31, 2007, and was
extended to March 31, 2008. The Note was secured by the right, title and interest in the purchased
assets. The purchase of these assets did not constitute the purchase of a business as defined in
EITF No. 98-3, Determining Whether a Nonmonetary Transaction Involves Receipt of Productive Assets
or of a Business, since no employees, equipment, manufacturing facilities or arrangements, or sales
and marketing organization were included in the transaction. Since the purchase was not a business,
the purchase price has been allocated based upon fair value assessments as follows: inventory $16.7
million, Abbokinase trade name $0.5 million and other identifiable intangibles $2.8 million. We
commenced selling Abbokinase in October 2006. Under the purchase agreement, after we received cash
proceeds of $5.0 million from the sale of Abbokinase, we were required to deposit 50% of the cash
received from sales of Abbokinase into an escrow account securing the repayment of the $15.0
million promissory note.
On March 31, 2008 the escrow agreement between us and Abbott laboratories expired and the $1.1
million balance in escrow was transferred to Abbott Laboratories on that date. On April 17, 2008,
we entered into a satisfaction, waiver and release agreement with Abbott Laboratories regarding
payment of the note. Under the terms of the agreement, we were required to pay Abbott Laboratories
$5.2 million in cash and upon payment of the funds, the debt obligation was deemed to be
indefeasibly paid in full by us and the note was cancelled and returned to us.
5. Asset Impairment and Restructuring
The asset impairment in the three and six months ended June 30, 2008 of $10.0 million is
comprised of $0.5 million related to the impairment of all laboratory equipment that has been
classified as available for sale on the balance sheet and $9.5 million related to the write-down of
our urokinase assets, which included $8.2 million for inventory and $1.3 million in intangible
assets. As part of our restructuring that we announced in June 2008, we are looking for strategic
alternatives for our core assets. In evaluating the urokinase assets in concert with the recent
restructuring activities and approvable letter issued by the FDA on our stability program, we
determined that the urokinase assets met the criteria under SFAS No. 144, Accounting for
Impairment or Disposal of Long-Lived Assets for impairment. The fair value of the assets were
determined by evaluating a potential sale of the assets which resulted in full impairment of the
intangible assets and a write-down of the inventory to $2.5 million.
Our board of directors authorized a restructuring that was implemented on June 11, 2008, that included a workforce reduction in which the employment of all of our employees other than
Bradford Zakes, our president and chief executive officer, and one additional employee were
terminated. The costs associated with these actions for the three and six months ended June 30,
2008 was $0.8 million, of which $0.5 million represents severance payments for the affected
employees, all of which were paid prior to June 30, 2008. Certain of the Companys former key
employees entered into consulting agreements with us in order to assist us in exploring strategic
alternatives for our commercial urokinase assets, clinical-stage SonoLysis program and other
assets. We determined that $44,000 of prepaid assets were no longer providing value and they were
written off as part of the restructuring. We also recorded a $40,000 accrued liability at June 30,
2008 for severance related to the payments of employee COBRA benefits. Finally, we recorded a $0.2
million liability for unutilized laboratory and corporate office space as required under SFAS No.
146, Accounting for Costs Associated with Exit or Disposal Activities.
9
6. Assets Held for Sale
In
connection with the June 11, 2008 restructuring, we discontinued all research and development
activity other than the on-going urokinase related stability program . As such, we initiated a
process to sell all of our laboratory equipment. We believe that this equipment will be sold no
later than the fourth quarter of 2008. We determined that the plan of sale criteria in SFAS No.
144, Accounting for the Impairment or Disposal of Long-Lived Assets, had been met. Accordingly,
the carrying value of the laboratory equipment was adjusted to its fair value less costs to sell,
amounting to $0.3 million, which was determined based on quoted market prices of similar assets.
7. Stock-Based Compensation
Stock Options
We maintain performance incentive plans under which incentive and non-qualified stock options
are granted primarily to employees and non-employee directors. Under SFAS 123R, the fair value of
each employee stock option is estimated on the date of grant using the Black-Scholes option pricing
model with the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, 2008 |
|
|
June 30, 2007 |
|
Expected dividend yield |
|
|
0.00 |
% |
|
|
0.00 |
% |
Expected stock price volatility |
|
|
84.42 |
% |
|
|
75.0 |
% |
Risk free interest rate |
|
|
3.67 |
% |
|
|
5.03 |
% |
Expected life of option |
|
7 years |
|
|
7 years |
|
The dividend yield assumption is based on our history and expectation of dividend payouts. We
use guideline companies to determine volatility. The expected life of the stock options is based on
simplified method which defines the life as the average of the contractual term of the options and
the weighted-average vesting period for all option tranches. The simplified method is permitted
after December 31, 2007 under SEC Staff Accounting Bulletin No. 110 (SAB 110). We chose to continue
using the simplified method because we have limited historical exercise data due to the limited
amount of time in which our shares have been publicly traded to provide a reasonable basis upon
which to estimate expected term. The risk-free interest rate assumption is based on observed
interest rates appropriate for the terms of our stock options.
We have two equity incentive plans; the 2000 Stock Plan (2000 Plan) and the 2007 Performance
Incentive Plan (2007 Plan). The 2000 Plan was terminated immediately following the closing of the
initial public offering on July 31, 2007. No additional grants will be issued from the 2000 Plan;
however, there are grants currently outstanding under this plan. The 2007 Plan became effective
July 25, 2007, the effective date of the Companys initial public offering. As of June 30, 2008,
the total compensation cost related to non-vested options not yet recognized is $1.2 million, which
will be charged to expense over the next 2.4 years.
A summary of activity under our stock plans is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
Weighted-Average |
|
|
|
|
|
|
|
Exercise Price |
|
|
Average |
|
|
Remaining |
|
|
|
Options |
|
|
Per Share |
|
|
Exercise Price |
|
|
Contractual Term |
|
Balance at December 31, 2007 |
|
|
1,534,269 |
|
|
$ |
2.10-30.00 |
|
|
$ |
6.81 |
|
|
|
|
|
Granted |
|
|
21,665 |
|
|
|
0.63-1.54 |
|
|
|
0.84 |
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canceled |
|
|
(757,092 |
) |
|
|
1.54-30.00 |
|
|
|
4.10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2008 |
|
|
798,842 |
|
|
$ |
0.63-30.00 |
|
|
$ |
9.78 |
|
|
|
8.36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at June 30, 2008 |
|
|
559,342 |
|
|
$ |
0.63-30.00 |
|
|
$ |
9.92 |
|
|
|
7.87 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
There was no aggregate intrinsic value on the options outstanding at June 30, 2008, since the
exercise price of all outstanding options was greater than the closing stock price on June 30,
2008.
10
Restricted Stock Awards
On May 30, 2008, non-employee directors were issued a total of 119,050 shares of restricted
stock at a grant date fair value of $0.63 per share for services rendered on the Companys board of
directors. The expense was recorded in the consolidated statement of operations under general and
administrative expense.
Option Modifications
On May 31, 2008, in connection with a termination of employment, stock options granted to an
executive officer were modified to accelerate the vesting for certain non-vested options by 12
months from the date of termination and the option exercise period was extended for 12 months.
Options to purchase 118,000 shares of common stock were subject to this acceleration, which
resulted in 29,500 shares vesting and a reduction in compensation expense of $3,000 in the three
and six months ended June 30, 2008 using the assumptions on the date of modification per SFAS No.
123 (revised 2004), Share-Based Payment.
On June 11, 2008, in connection with termination of employment, the stock options granted to
two executive officers were modified to accelerate the vesting for certain non-vested options by 12
months from the date of termination and the option exercise period was extended for 12 months.
Options to purchase 399,666 shares of common stock were subject to this acceleration, which
resulted in 164,582 shares vesting and a reduction in compensation expense of $0.1 million in the
three and six months ended June 30, 2008 using the assumptions on the date of modification per SFAS
No. 123 (revised 2004), Share-Based Payment.
8. Net Loss per Share
Basic and diluted net loss attributable to common stockholders per share is calculated by
dividing the net loss applicable to common stockholders by the weighted-average number of common
shares outstanding during the period. Diluted net loss per common share is the same as basic net
loss per common share for all periods presented. The effects of potentially dilutive securities are
antidilutive in the loss periods.
The potential common shares have been excluded from the computation of diluted net loss per
share since their effect would be antidilutive in each of the loss periods presented. The shares
have been revised to account for the six-for-ten reverse stock split that was affected in September
2006 as well as the one-for-three reverse stock split that occurred in May 2007. Herein all shares
presented in this quarterly report on Form 10-Q have been adjusted to reflect these stock splits.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six months Ended June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Net loss attributed to common stockholders |
|
$ |
(7,270 |
) |
|
$ |
(1,921 |
) |
|
$ |
(9,800 |
) |
|
$ |
(4,752 |
) |
Basic and diluted weighted average common
shares outstanding |
|
|
10,087,238 |
|
|
|
2,606,019 |
|
|
|
10,067,072 |
|
|
|
2,605,968 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.72 |
) |
|
$ |
(0.74 |
) |
|
$ |
(0.97 |
) |
|
$ |
(1.82 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
The following potential common shares have been excluded from the computation of diluted net
loss per share since their effect would be antidilutive in each of the loss periods presented:
|
|
|
|
|
|
|
|
|
|
|
At June 30, |
|
|
|
2008 |
|
|
2007 |
|
Convertible preferred stock |
|
|
|
|
|
|
4,401,129 |
|
Stock options |
|
|
798,842 |
|
|
|
545,244 |
|
Warrants |
|
|
1,023,913 |
|
|
|
352,324 |
|
9. Segment Information
We are engaged in the discovery, development and commercialization of therapies for vascular
disorders. We have only one reportable segment and, therefore, all segment-related financial
information required by Statement of Financial Accounting Standards No. 131, Disclosures About
Segments of an Enterprise and Related Information, is included in the consolidated financial
statement. The reportable segment reflects our structure, reporting responsibilities to the chief
executive officer and the nature of the products under development.
11
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations.
Cautionary Statement Regarding Forward-Looking Statements
The following discussion should be read in conjunction with the accompanying unaudited
Consolidated Financial Statements and related notes appearing elsewhere in this report. This
Quarterly Report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. We cannot guarantee the
accuracy of the forward-looking statements, and you should be aware that results and events could
differ materially and adversely from those contained in the forward-looking statements. You should
also consider carefully the statements set forth in Item 1A of Part II of this Quarterly Report
entitled Risk Factors which address these and additional factors that could cause results or
events to differ materially from those set forth in the forward-looking statements.
Our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K and amendments to all such
reports are available, free of charge, on our Internet website under Investors-Financial
Information, as soon as reasonably practicable after we file electronically such reports with, or
furnish such reports to, the SEC. Our Internet website address is http://www.imarx.com. Information
on our website does not constitute a part of this Quarterly Report on Form 10-Q. As used in this
quarterly report on Form 10-Q, unless the context otherwise requires, the terms we, us, our,
the Company, and ImaRx refer to ImaRx Therapeutics, Inc., a Delaware corporation, and its
subsidiaries.
Overview
We are a biopharmaceutical company with one commercially available product, urokinase, and a
research and development program centered on our proprietary microbubble technology together with
ultrasound.
Urokinase is a thrombolytic drug formerly marketed under the brand name Abbokinase® and is
currently being re-branded as Kinlytic. Urokinase is approved by the U.S. Food and Drug
Administration, or FDA, for the treatment of acute massive pulmonary embolism, or blood clots in
the lungs.
Our research and development efforts have focused on the development of therapies for stroke
and other vascular disorders, using our proprietary microbubble technology together with
ultrasound. Our lead program, SonoLysis, involves the administration of our proprietary MRX-801
microbubbles and ultrasound to break up blood clots and restore blood flow to oxygen deprived
tissues.
On June 11, 2008, we announced a restructuring that included a significant workforce
reduction. Company management and our board of directors determined that the restructuring was
necessary in light of the termination of our agreement with Microbix Biosystems relating to the
sale of our urokinase inventory and related assets, notification from the FDA that additional
testing would be required for approval of our urokinase stability testing program and release of
labeled vials of urokinase, our cash position and the lack of new capital resources to fund our
commercial and development programs. As part of the restructuring,
all of our employees other than Bradford Zakes, our president and chief executive officer, and one
additional employee were terminated. We paid a retention bonus to each of the remaining employees
and entered into agreements with each of them to reimburse us a portion of the retention bonus
should they voluntarily leave the employ of the Company prior to
certain agreed upon dates.
In furtherance of the June 2008 restructuring we are now exploring strategic alternatives for
our commercial urokinase assets, clinical-stage SonoLysis program and other company assets. Certain
of the our former key employees entered into consulting agreements with us in order to assist us in
these efforts. Additionally, we are performing the additional testing required by the FDA prior to
securing release of previously submitted commercial inventory of urokinase from the FDA. We have
retained the services of a CRO to assist in performing the FDA required tests. Upon completion of
the testing procedures we will submit the results to the FDA for review. If the data are
sufficient for the FDA to approve lot release, we may be in a position to begin sales of our
labeled vials of urokinase with extended expiration dating in the fourth quarter of 2008.
12
As a result of the events leading to our June 2008 restructuring, we have new risks and
challenges facing us. Historically, one of our primary sources of cash has been the sale of our
urokinase product. Due to the FDAs requirement of additional testing as a prerequisite to the
release of the urokinase lots, and the uncertainty as to the outcome of any such testing, our
actual proceeds from
sales of urokinase may fall short of previous projections. We do not currently have any other
significant source of cash. One of the strategic alternatives being considered is the sale of all
of the commercial urokinase assets to an unrelated party. If we are unsuccessful in securing
release of the urokinase lots from the FDA in a timely manner, or at all, and/or, we are not able
to enter into a strategic transaction with respect to our commercial urokinase assets or SonoLysis
program that results in the receipt of additional cash resources we will only have sufficient
capital to fund our operating needs into the fourth quarter 2008. Costs associated with the June
2008 restructuring were $0.8 million, of which $0.5 million was associated with severance paid to
employees, $44,000 was related to prepaid assets written off that we are no longer receiving
economic benefit from, $40,000 for COBRA benefits to be paid on behalf of terminated employees and
$0.2 million related to unutilized laboratory and corporate office space as required under SFAS No.
146, Accounting for Costs Associated with Exit or Disposal
Activities.
Product Sales, Research and Development Revenue
Our primary source of revenue is derived from sales of our urokinase product currently sold as
Abbokinase and being re-branded as Kinlytic. We commenced sales of urokinase in October 2006 and
have been generating revenue from sales of this product since that date. Future revenues from sales
of urokinase will be impacted by our ability to secure release of previously submitted labeled
commercial inventory of urokinase from the FDA and our ability to extend the expiration dating of
the currently unlabeled vials. In addition to our commercial product sales, we also generate a
limited amount of revenue by providing research services for projects funded under various
government grants. Revenues associated with research services will be reduced in future periods as
all research activities have been eliminated.
All product sales recorded to date relate to sales of urokinase in the United States. Due to
our limited returns history and the fact that customers may return expired urokinase product that
is in its original, unopened cartons within 12 months past the product expiration date, we
currently account for these product shipments using a deferred revenue recognition model. We do not
recognize revenue upon product shipment to a wholesale distributor but rather, we defer the
recognition of revenue until the right of return no longer exists or when the product is sold to
the end user as is stipulated by SFAS No. 48, Revenue Recognition When the Right of Return Exists.
We record product sales net of chargebacks, distributor fees, discounts paid to wholesale
distributors, and administrative fees paid to Group Purchasing Organizations (GPOs). The allowances
are based on historical information and other pertinent data. As of June 30, 2008, we had deferred
revenue of $2.6 million.
Cost of Product Sales
Cost of product sales is determined using a weighted-average method and includes the
acquisition cost of the inventory as well as additional labeling costs we incur to bring the
product to market. Our product pricing is fixed, but could include a variable sales or cash
discount depending on the nature of the sale. Our gross margins are affected by chargebacks,
discounts and administrative fees paid to the wholesale distributors and GPOs.
Research and Development Expenses
We classify our research and development expenses into four categories of activity, namely:
research, development, clinical and regulatory. To date, our research and development efforts have
been focused primarily on product candidates from our SonoLysis program. We do not expect to expend
significant resources on this program as we are seeking strategic alternatives. As part of our
restructuring effort announced in June 2008, we have ceased all research related activities related
to our SonoLysis program.
General and Administrative Expenses
General and administrative expenses consist primarily of personnel-related expenses and other
costs and fees associated with our general corporate activities, such as administrative support,
business development, public reporting and corporate compliance, as well as a portion of our
overhead expenses. We have incurred and will continue to incur additional expenses in the areas of
legal compliance, accounting and corporate governance as a public company.
13
Critical Accounting Policies and Significant Judgments and Estimates
Our managements discussion and analysis of our financial condition and results of operations
are based on our consolidated financial statements, which have been prepared in accordance with
accounting principles generally accepted in the United States The preparation of these consolidated
financial statements requires us to make estimates and assumptions that affect the reported amounts
of assets and liabilities, the disclosed amounts of contingent assets and liabilities and our
reported revenue and expenses. Significant management judgment is required to make estimates in
relation to inventory and intangible asset valuation, clinical trial costs and previous costs
associated with transitioning to a public reporting company. We evaluate our estimates, and
judgments related to these estimates, on an ongoing basis. We base our estimates of the carrying
values of assets and liabilities that are not readily apparent from other sources on historical
experience and on various other factors that we believe are reasonable under the circumstances.
Actual results may differ from these estimates under different assumptions or conditions. There has
been no significant change in our critical accounting policies or estimates from those policies or
estimates disclosed under the heading Critical Accounting Policies and Significant Judgments and
Estimates in our Annual Report on form 10-K/A filed with the Securities and Exchange Commission on
April 3, 2008 except for those discussed below under Inventory and Inventory Subject to Return
and Long-lived and Intangible Assets.
Inventory and Inventory Subject to Return
Inventory of urokinase, our only commercially available FDA approved product, is comprised of
finished goods and is stated at the lower of cost or market value. Urokinase is currently being
sold under the brand name Abbokinase. We are re-branding the product to be sold under the brand
name Kinlytic. Inventory value was initially determined as a result of the purchase price
allocation from the acquisition of this product from Abbott Laboratories in 2006. We periodically
review the composition of inventory in order to identify obsolete, slow-moving or otherwise
un-saleable inventory.
We have an ongoing stability and release testing program to support expiration date extensions
for the unlabeled vials. Under our agreement with Abbott Laboratories we were required to transfer
the stability and release testing program from Abbott to another laboratory. The transfer of the
stability and release testing program to the laboratory of a contract research organization, or
CRO, has been completed and we have submitted to the FDA a Changes Being Effected in 30 days
supplemental new drug application, or CBE-30, requesting approval for the transfer. Under the
CBE-30, if the FDA does not object within 30 days of receiving the supplement and the supplement is
filed, the requested change(s) may take effect. However, even if the 30 day period lapses without
objection, under the Prescription Drug User Fee Act or PDUFA, the FDA must still take formal action
to approve or not approve the application within 180 days of receipt of the submission. The 30 day
period passed without an objection and our application was filed. We subsequently submitted to the
FDA lot release requests for inventory labeled with the new expiration dating. In the first quarter
of 2008 the FDA approved the lot release requests and the inventory was subsequently labeled.
Subsequently, we received formal notice from the FDA that before our application for approval of
the transfer of the stability and release testing program from Abbott to the CRO may be approved,
we must first revise our stability and release program to include additional assays that detect
modified forms of the active pharmaceutical ingredient or API. The FDA further indicated that the
lots it released during the first quarter of 2008 will need to be tested for sub-visible
particulates prior to distribution to the general public. The FDAs newly required tests are part
of an FDA initiative to align stability programs for products, such as urokinase, with extended
expiration dating to current FDA standards.
In light of the FDA action, we evaluated the carrying value of the inventory
and determined that the value of the inventory as of
June 30, 2008 had been impaired and as a result we reduced the
value of the inventory by $8.2 million, to its market value. As of June 30, 2008, 34% of the vials
in inventory held by our wholesale distributors, or $1.3 million in inventory value will expire at
various times up to September 2009. Once labeled inventory expires it cannot be relabeled and sold.
The remaining inventory will not be saleable unless and until our stability testing program has been approved
by the FDA and we have data supporting further expiration dating for the inventory. We will
continue to monitor these efforts and evaluate the adequacy of our inventory obsolescence reserves.
We have retained the services of a CRO to assist in performing the FDA required tests with
respect to the analysis for sub-visible particulates. Upon completion of the testing procedures we
will submit the results to the FDA for review. If the data are sufficient for the FDA to approve
release of the lots, we may be in a position to begin sales of our labeled vials of urokinase with
extended expiration dating in the fourth quarter of 2008. We intend to continue the stability
program to potentially enable further expiration extensions for unlabeled vials of inventory.
Release of future lots with expiration dating beyond the currently labeled vials will be contingent
upon FDA approval of the stability testing program and FDA acceptance of the testing results. Even
if the stability testing program is accepted and the testing results are favorable, it is uncertain
whether or to what extent the FDA might approve extended expiration dating for our inventory of
unlabeled urokinase vials.
14
Long-lived and Intangible Assets
We account for long-lived assets in accordance with the provisions of SFAS No. 144, Accounting
for the Impairment or Disposal of Long-Lived Assets (SFAS 144). SFAS 144 addresses financial
accounting and reporting for the impairment or disposal of long-lived assets. This Statement
requires that long-lived assets be reviewed for impairment whenever events or changes in
circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability
is measured by comparing the carrying amount of an asset to the expected future net cash flows
generated by the asset. If it is determined that the asset may not be recoverable and if the
carrying amount of an asset exceeds its estimated fair value, an impairment charge is recognized to
the extent of the difference. SFAS 144 requires companies to separately report discontinued
operations, including components of an entity that either have been disposed of (by sale,
abandonment or in a distribution to owners) or classified as held for sale. Assets to be disposed
of are reported at the lower of the carrying amount or fair value less costs to sell.
In the three and six months ended June 30, 2008, we evaluated our intangible assets for
impairment due to the receipt of the approvable letter from the FDA and determined that all of the
intangible assets were impaired. As such, these intangibles were
written off by recording a
$1.3 million impairment. We also initiated a plan to sell our laboratory equipment, which we
valued at fair value and recorded a $0.5 million impairment. The assets are classified as held for
sale.
Deferred Tax Asset Valuation Allowance
Our estimate of the valuation allowance for deferred tax assets requires us to make
significant estimates and judgments about our future operating results. Our ability to realize the
deferred tax assets depends on our future taxable income as well as limitations on utilization. A
deferred tax asset must be reduced by a valuation allowance if it is more likely than not that some
portion or all of the deferred tax asset will not be realized prior to its expiration. The
projections of our operating results on which the establishment of a valuation allowance are based
involve significant estimates regarding future demand for our products, competitive conditions,
product development efforts, approvals of regulatory agencies and product cost. We have recorded a
full valuation allowance on our net deferred tax assets due to uncertainties related to our ability
to utilize our deferred tax assets in the foreseeable future. These deferred tax assets primarily
consist of net operating loss carry forwards and research and development tax credits. Under
Section 382 of the Internal Revenue Code of 1986, as amended, substantial changes in our ownership
may limit the amount of net operating loss carry-forwards that could be utilized annually in the
future to offset taxable income.
Revenue Recognition
Revenue from product sales is recognized pursuant to Staff Bulletin No. 104 (SAB 104), Revenue
Recognition in Financial Statements. Accordingly, revenue is recognized when all four of the
following criteria are met: (i) persuasive evidence that an arrangement exists; (ii) delivery of
the products has occurred; (iii) the selling price is both fixed and determinable; and (iv)
collectability is reasonably assured. We apply SFAS No. 48, Revenue Recognition When the Right of
Return Exists, which among other criteria requires that future returns can be reasonably estimated
in order to recognize revenue. The amount of future returns is uncertain due to the insufficiency
of returns history data. Due to the uncertainty of returns, we are accounting for these product
shipments to wholesale distributors using a deferred revenue recognition model. Under this model,
we do not recognize revenue upon product shipment to wholesale distributors; therefore, recognition
of revenue is deferred until the product is sold by the wholesale distributor to the end user.
Our customers consist primarily of large pharmaceutical wholesale distributors who sell
directly to hospitals and other healthcare providers. Provisions for product returns and exchanges,
sales discounts, chargebacks, managed care and Medicaid rebates and other adjustments are
established as a reduction of product sales revenues at the time such revenues are recognized.
These deductions from gross revenue are established by us as our best estimate at the time of sale
adjusted to reflect known changes in the factors that impact such reserves.
We provide research services under certain grant agreements, including federal grants from the
National Institutes of Health. We recognize revenue for these research services as the services are
performed. Revenue from grants is recognized over the contractual period of the related award.
15
Results of Operations
Three Months Ended June 30, 2007 Compared to 2008
Product Sales, Research and Development Revenue. Our total revenues remained constant at $2.1
million in the second quarter of 2007 and 2008. Our urokinase sales to end users remained constant
at $2.0 million in the first quarter of 2007 and 2008.
Cost of Product Sales. Cost of product sales was $1.0 million in the second quarter of 2007
compared to $0.9 million for the second quarter of 2008. The cost of product sales includes the
price paid to acquire the product as well as labeling costs that are directly incurred in bringing
the product to market.
Research and Development Expenses. Research and development expenses decreased from $1.6
million in the second quarter of 2007 to $1.0 million in the second quarter of 2008. This decrease
is related to lower clinical trial costs associated with the wind down of our clinical trial and
reduced stock-based compensation expense as a result of higher forfeitures.
General and Administrative Expenses. General and administrative expenses increased from $1.2
million in the second quarter of 2007 to $3.0 million in the second quarter 2008. This increase was
principally a result of severance costs, the accrual of unutilized office space in relation to our
restructuring and an increase in marketing costs related to our product rebranding efforts.
Interest and Other Income, net. Interest and other income decreased from income of $0.1
million in the second quarter 2007 to other expense of $0.1 million in the second quarter of 2008,
primarily as a result of a decrease in interest earned due to lower cash balances and lower
interest rates and the loss on sale of assets in the second quarter of 2008.
Asset Impairment. The asset impairment in the second quarter of 2008 of $10.0 million is
related to a $0.5 million impairment of laboratory equipment that has been classified as available
for sale and a $9.5 million impairment related to the write-down of our urokinase assets.
Gain on extinguishment of debt. Gain on extinguishment of debt increased from $0.2 million in
the second quarter of 2007 to $5.6 million in the second quarter of 2008. The extinguishment of
debt in the second quarter of 2007 is related to a debt for patent costs and the extinguishment of
debt in the second quarter of 2008 is related to the satisfaction, waiver and release agreement
signed with Abbott Laboratories related to our note payable for the purchase of the urokinase
assets.
Six Months Ended June 30, 2007 Compared to 2008
Product Sales, Research and Development Revenue. Our total revenues increased from $3.4
million for the six month period ended June 30, 2007 to $4.1 million for the same period in 2008,
primarily due to increased sales of our urokinase product.
Cost of Product Sales. Cost of product sales was $1.4 million for the six month period ended
June 30, 2007 compared to $1.8 million for the six month period ended June 30, 2008. The cost of
product sales includes the price paid to acquire the product as well as labeling costs that are
directly incurred in bringing the product to market. The increase in cost of product sales is
related to the increase in the number of vials sold through to hospitals or other end users.
Research
and Development Expenses. Research and development expenses
decreased from $3.1 million for the six month period ended June 30, 2007 to $2.6 million for the same period in 2008.
This decrease was principally a result of reduced clinical trials costs as a result of the wind
down or our clinical trial, a reduction in laboratory supplies and travel costs due to the
reduction in research activities offset partially by an increase in work performed by third parties
on the grants.
General
and Administrative Expenses. General and administrative expenses increased from $2.6 million for the six month period ended June 30, 2007 to $5.0 million for the same period in 2008.
This increase was principally a result of severance costs, an increase in costs associated with
maintaining public company infrastructure and increased marketing costs related to the rebranding
of our urokinase product offset partially by a decrease in amortization.
Interest and Other Income, net. Interest and other income was $0.1 million for the six month
period ended June 30, 2007 and $36,000 for the six month period ended June 30, 2008. The reduction
is related to a loss recorded on the sale of assets.
Asset Impairment. The asset impairment in the six months ended June 30, 2008 of $10.0 million
is related to a $0.5 million impairment of all laboratory equipment that has been classified as
available for sale and a $9.5 million impairment related to the write-down of our urokinase assets.
16
Gain on extinguishment of debt. Gain on extinguishment of debt was $0.2 million for the six
months ended June 30, 2007 related to a debt for patent costs and $5.6 million for the six months
ended June 30, 2008 related to the satisfaction, waiver and release agreement signed with Abbott
Laboratories relate to our note payable for the purchase of the urokinase assets.
Liquidity and Capital Resources
Sources of Liquidity
We have incurred losses since our inception. At June 30, 2008, we had an accumulated deficit
of $91.0 million. We have historically financed our operations principally through the public
offering and private placement of shares of our common and preferred stock and convertible notes,
government grants, and, more recently, product sales of urokinase, which commenced in October 2006.
During the year ended December 31, 2007, we received net proceeds of $12.4 million from the
issuance of shares of our common stock and $14.2 million from sales of urokinase inventory to
certain of our wholesaler distributors. At June 30, 2008, we had $2.1 million in cash and cash
equivalents.
In April 2006, we acquired from Abbott Laboratories the assets related to urokinase, including
the remaining inventory of finished product, all regulatory and clinical documentation, validated
cell lines, and intellectual property rights, including trade secrets and know-how relating to the
manufacture of urokinase using the tissue culture method. The purchase price for the assets was
$20.0 million, which was paid in the form of $5.0 million in cash and the issuance of a $15.0
million non-recourse promissory note with an initial maturity date of December 31, 2007, which was
extended to March 31, 2008. On April 17, 2008, we entered into a satisfaction, waiver and release
agreement with Abbott Laboratories regarding payment of the note. Under the terms of the agreement,
we were required to pay Abbott Laboratories $5.2 million in cash and upon payment of the funds, the
debt obligation was deemed to be indefeasibly paid in full by us and the note was cancelled and
returned to us.
The exact timing and amount of future sales of urokinase will depend on a number of external
factors, such as our ability to obtain an extension of the expiration dating for the urokinase
inventory, our ability to establish additional sales relationships with customers for that product,
our inventory levels at the wholesale distributors that are currently stocking the product, and
other competitive and regulatory factors. Based on current stability data as of June 30, 2008, all
vials of our urokinase inventory expire at various times up to September 2009. We have an ongoing
stability and release testing program to support expiration date extensions for the unlabeled
vials. Under our agreement with Abbott Laboratories were required to transfer the stability and
release testing program from Abbott to another laboratory. The transfer of the stability and
release testing program to the laboratory of a contract research organization, or CRO, has been
completed and we have submitted to the FDA a Changes Being Effected in 30 days supplemental new
drug application, or CBE-30, requesting approval for the transfer. Under the CBE-30, if the FDA
does not object within 30 days of receiving the supplement and the supplement is filed, the
requested change(s) may take effect. However, even if the 30 day period lapses without objection,
under the Prescription Drug User Fee Act or PDUFA, the FDA must still take formal action to approve
or not approve the application within 180 days of receipt of the submission. The 30 day period
passed without an objection and our application was filed. We subsequently submitted to the FDA lot
release requests for inventory to be labeled with the new expiration dating. In the first quarter
of 2008 the FDA approved the lot release requests and approximately thirty thousand vials of
urokinase inventory was subsequently labeled. Subsequently, we
received formal notice from the FDA
that before our application may be approved, we must first revise our stability and release program
to include additional assays that detect modified forms of the active pharmaceutical ingredient or
API. The FDA further indicated that the lots it released during the first quarter of 2008 will need
to be tested for sub-visible particulates prior to distribution to the general public. The FDAs
newly required tests are part of an FDA initiative to align stability programs for products, such
as urokinase, with extended expiration dating to current FDA standards.
We have retained the services of a CRO to assist in performing the FDA required tests with
respect to the analysis for sub-visible particulates. Upon completion of the testing procedures we
will submit the results to the FDA for review. If the data are sufficient for the FDA to approve a
lot release, we may be in a position to begin sales of our labeled vials of urokinase with extended
expiration dating in the fourth quarter of 2008. We intend to continue the stability program to
potentially enable further expiration extensions for unlabeled vials of inventory. Release of
future lots with expiration dating beyond the currently labeled vials will be contingent upon FDA
approval of the stability testing program and FDA acceptance of the testing results. Even if the
stability testing program is accepted and the testing results are favorable, it is uncertain
whether or to what extent the FDA might approve extended expiration dating for our inventory of
unlabeled urokinase vials. If the FDA objects to the methods or results of the stability testing
program, we estimate that 66% of inventory held by us or our wholesale distributors that we expect
hospitals to purchase, or $2.5 million in inventory value out of the total of $3.8 million carried
at June 30, 2008, is at risk of expiring.
17
Cash Flows
Net Cash Provided by or Used in Operating Activities. Net cash provided by operating
activities in the six months ended June 30, 2007 primarily reflects net loss offset in part by
changes in working capital. Net cash used in operating activities in the six months ended June 30,
2008 primarily reflects the net loss and the gain on extinguishment of debt offset in part by asset
impairment charges, changes in working capital and depreciation.
Net Cash Used in Investing Activities. Net cash used in investing activities was $0.3 million
and $11,000 for the six months ended June 30, 2007 and 2008, respectively. Net cash used in
investing activities primarily reflects purchases of property and equipment, including
manufacturing, information technology, laboratory and office equipment.
Net Cash Used in Financing Activities. Net cash used in financing activities was $5.4 million
for the six months ended June 30, 2007 and $5.9 million for the same period in 2008. Net cash used
in financing activities for the six months ended June 30, 2007 was attributable to the deferred
financing costs of $1.0 million and $4.4 million place in escrow to pay down the note payable to
Abbott Laboratories related to the $15.0 million non-recourse not for the purchase of the urokinase
assets. Net cash used in financing activities for the six months ended June 30, 2008 was
attributable to the $6.3 million payment on the note payable to Abbott Laboratories offset
partially by the $0.4 million change in the restricted cash balance.
Operating Capital and Capital Expenditure Requirements
As a result of the events leading to our June 2008 restructuring, we have new risks and
challenges facing us. Historically, our primary source of liquidity has been the public offering
and private placement of shares of our common and preferred stock and convertible notes, government
grants, and, more recently, product sales of urokinase. Due to the FDAs requirement of additional
testing as a prerequisite to the release, and the uncertainty as to the outcome of any such
testing, our actual proceeds from sales of urokinase may fall short of previous projections. We do
not currently have any other significant source of cash.
In furtherance of the June 2008 restructuring we are now exploring strategic alternatives for
our commercial urokinase assets, clinical-stage SonoLysis program and other company assets, which
may involve the disposition of substantially all of these assets. Additionally, we are performing
the additional testing required by the FDA prior to securing release of previously submitted
commercial inventory of urokinase from FDA. If we are unsuccessful in securing release of the
urokinase lots from the FDA in a timely manner, or at all, and/or, we are not able to enter into a
strategic transaction with respect to our commercial urokinase assets or SonoLysis program that
results in the receipt of additional cash resources, we may not have sufficient capital to fund our
operating needs into the fourth quarter 2008. Our operating needs include the planned costs to
operate our business and the amount required to fund our working capital and capital expenditures.
At the present time, we have no material commitments for capital expenditures.
We may not be successful in commercializing urokinase or in obtaining such additional proceeds
or revenue. We cannot be sure that our existing cash and cash equivalents will be adequate, or that
additional financing will be available when needed, or that, if available, such financing will be
obtained on terms favorable to us or our stockholders. Failure to obtain adequate cash resources
may adversely affect our ability to operate as a going concern. If we raise additional funds by
issuing equity securities, or enter into a strategic transaction, substantial dilution to existing
stockholders will likely result. If we raise additional funds by incurring debt obligations, the
terms of the debt will likely involve significant cash payment obligations as well as covenants and
specific financial ratios that may restrict our ability to operate our business.
Item 4T. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures. Under the supervision and with the
participation of our management, including our principal executive officer and principal financial
officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures,
as such term is defined under Rule 13a-15(e) promulgated under the Securities Exchange Act of 1934,
as amended. Based on that evaluation and due to the restructuring plan initiated in June 2008
including the significant reduction in personnel in the accounting and finance function, our
principal executive officer and principal financial officer concluded that our disclosure controls
and procedures were ineffective as of the end of the period covered by this quarterly report.
Change in Internal Control over Financial Reporting. As a result of the restructuring plan
initiated in June 2008 including the significant reduction in personnel in the accounting and
finance function there have been changes in our internal control environment that may materially
affect our internal control over financial reporting. Based on that evaluation, our principal
executive officer and
principal financial officer concluded that our internal control over
financial reporting were ineffective as of the end of the period covered by this quarterly report.
18
PART II
OTHER INFORMATION
Item 1. Legal Proceedings.
As of the date of this Quarterly Report on Form 10-Q, we were not involved in any material
legal proceedings.
Item 1A. Risk Factors.
The following information sets forth material changes from the risk factors we previously disclosed
in our Annual Report on Form 10-K/A for the year ended 2007 and Form 10-Q for first quarter ended
March 31, 2008. These risks, among others, could cause our actual operating results to differ
materially from those indicated or suggested by forward-looking statements made in this Quarterly
Report on Form 10-Q or presented elsewhere by management from time to time. If any of the following
risks actually occur, our business, operating results, prospects or financial condition could be
harmed. Additional risks including those previously disclosed in our filings with the SEC as well
as those not presently known to us or those that we currently deem immaterial, may also affect our
business operations.
We may not be able to identify or consummate a strategic transaction for our commercial urokinase
assets, clinical-stage SonoLysis program and other company assets. We do not have adequate
resources to continue these activities ourselves and must find strategic partners or alternative
funding sources in order to continue these activities.
On June 11, 2008, following termination of an agreement with Microbix Biosystems relating to
the sale of our urokinase inventory and related assets and our receipt of a letter from the FDA
indicating that additional testing would be required for approval of our urokinase stability
testing program and release of labeled vials of urokinase, we announced a restructuring that
included a significant workforce reduction. In furtherance of the June 2008 restructuring we are
now exploring strategic alternatives for our commercial urokinase assets, clinical-stage SonoLysis
program and other company assets. We may not be able to successfully achieve the desired benefits
of any strategic alternative undertaken by us. There can be no assurance that we will identify any
attractive strategic opportunities or that if we identify one that we will consummate a transaction
on favorable terms. If the exploration of strategic alternatives does result in a transaction, we
are unable to predict what the market prices of our common stock would be after the announcement of
such a transaction. In addition, the market price of our stock could be highly volatile as we
explore strategic alternatives and may be more volatile if and when a transaction is announced.
The FDA may not approve our stability program under which we seek extension of the expiration
dating of Kinlytic and we may be unable to sell our existing inventory of Kinlytic before product
expiration.
We have an ongoing stability and release testing program to support expiration date extensions
for the unlabeled vials. Under our agreement with Abbott Laboratories we were required to transfer
the stability and release testing program from Abbott to another laboratory. The transfer of the
stability and release testing program to the laboratory of a contract research organization, or
CRO, has been completed and we have submitted to the FDA a Changes Being Effected in 30 days
supplemental new drug application, or CBE-30, requesting approval for the transfer. Under the
CBE-30, if the FDA does not object within 30 days of receiving the supplement and the supplement is
filed, the requested change(s) may take effect. However, even if the 30 day period lapses without
objection, under the Prescription Drug User Fee Act or PDUFA, the FDA must still take formal action
to approve or not approve the application within 180 days of receipt of the submission. The 30 day
period passed without an objection and our application was filed. We subsequently submitted to the
FDA lot release requests for inventory to be labeled with the new expiration dating. In the first
quarter of 2008 the FDA approved the lot release requests.
Subsequently, we received formal notice from the FDA that our request for approval of the transfer of the stability and release testing
program from Abbott to the CRO is approvable. The FDA notified us that before our application may
be approved, we must first revise our stability and release program to include additional assays
that detect modified forms of the active pharmaceutical ingredient or API. The FDA further
indicated that the lots it released during the first quarter of 2008 will need to be tested for
sub-visible particulates prior to distribution to the general public. The FDAs newly required
tests are part of an FDA initiative to align stability programs for products, such as
urokinase, with extended expiration dating to current FDA standards. If we are unable to obtain FDA
approval of our stability and release testing program or if our inventory does not pass the
additional testing procedures our remaining inventory may expire prior to being sold and sales of
Kinlytic will be reduced and we may not have sufficient resources to fund our current operations
beyond the fourth quarter 2008.
19
The Kinlytic brand name for our urokinase product is unfamiliar to our market. We have no sales and
marketing capabilities and depend on drug wholesalers to distribute our Kinlytic product.
Our urokinase product was previously marketed by Abbott Laboratories and us as Abbokinase.
Following extension of the expiration dates of our urokinase inventory, we were required pursuant
to the terms of the asset purchase agreement with Abbott Laboratories to re-brand the urokinase
inventory. We received FDA approval to use the Kinlytic brand name in our labeling of urokinase. In
connection with the June 2008 restructuring, all sales and marketing personnel were terminated and
we no longer have any personnel engaged in those activities. We do not have sufficient resources
to effectively market or sell urokinase under the brand name Kinlytic. We have no sales and
marketing staff and depend on the efforts of third parties for the sale and distribution of
Kinlytic to hospitals and clinics. The new brand name Kinlytic may cause confusion or lead to
rejection of the product by hospitals and clinics whose pharmaceutical formularies include
Abbokinase, but not Kinlytic. If we are unable to maintain effective third party distribution
channels on commercially reasonable terms, we may be unable to market and sell Kinlytic in
commercial quantities. Drug wholesale companies may be unwilling to continue selling Kinlytic, or
we may be forced to accept lower prices or other unfavorable terms or to expend significant
additional resources to sell our Kinlytic inventory.
We will need additional capital to fund our operation into the fourth quarter 2008 and beyond. If
we are unable to identify or consummate an attractive strategic transaction for our commercial
urokinase assets, clinical-stage SonoLysis program or other company assets in a timely manner we
may be forced to delay, reduce or eliminate these activities and we may be unable to timely pay our
debts.
We believe that our cash, cash equivalents and investments will be sufficient to fund our
continuing operations and other demands and commitments into the fourth quarter 2008. Our funding
requirements will, however, depend on numerous factors, including:
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the timely release by the FDA of the commercial lots of urokinase currently undergoing
FDA review; |
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the timing and amount of revenue from sales of urokinase; |
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the timing and amount of revenue from a strategic transaction for our commercial
urokinase assets, clinical-stage SonoLysis program and other company assets; |
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personnel, facilities and equipment requirements; and |
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the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent
claims and other patent-related costs, including litigation costs, if any, and the result of
any such litigation. |
We cannot be certain that we will generate any additional funding. We may be forced to accept
terms on a strategic transaction that are highly dilutive or otherwise disadvantageous to our
existing stockholders. If we are unable to secure adequate financing, we could be required to
cease operations.
We have only two full-time employees and consulting relationships with certain other former key
employees. We may not have sufficient personnel to effectively identify or consummate an
attractive strategic transaction for our commercial urokinase assets, clinical-stage SonoLysis
program and other company assets in a timely manner, or at all.
Our success depends substantially on the services of our two employees and key consultants.
The loss of the services of one or more of these persons could have a material adverse effect on
our business. Each of these persons may terminate his or her relationship with the us without
notice and without cause or good reason. Our ability to identify or consummate an attractive
strategic transaction for our commercial urokinase assets, clinical-stage SonoLysis program and
other company assets is substantially dependent on these persons and without them we cannot be
certain that we will be able to do accomplish our business objectives.
20
We are at risk of securities class action litigation due to our stock price volatility.
We are at risk of being subject to securities class action lawsuits if our stock price
declines substantially. Securities class action litigation has often been brought against other
companies following a decline in the market price of its securities. While no securities class
action claims have been brought against us, it is possible that lawsuits will be filed based on
such stock price declines naming our company, directors, and officers. Securities litigation could
result in substantial costs, divert managements attention and resources, and seriously harm our
business, financial condition and results of operations.
Failure of our internal control over financial reporting could harm our business and financial
results.
Our management is responsible for establishing and maintaining effective internal control over
financial reporting. Internal control over financial reporting is a process to provide reasonable
assurance regarding the reliability of financial reporting for external purposes in accordance with
accounting principles generally accepted in the U.S. Internal control over financial reporting
includes: (i) maintaining reasonably detailed records that accurately and fairly reflect our
transactions; and (ii) providing reasonable assurance that we (a) record transactions as necessary
to prepare the financial statements, (b) make receipts and expenditures in accordance with
management authorizations, and (c) would timely prevent or detect any unauthorized acquisition, use
or disposition of our assets that could have a material effect on the financial statements. As a
result of the restructuring plan initiated in June 2008 management believes that there have been
changes in our internal control environment that may materially affect our internal control over
financial reporting. Based on that evaluation, our principal executive officer and principal
financial officer concluded that our internal control over financial
reporting were ineffective
as of the end of the period covered by this quarterly report.
Because of its inherent limitations, internal control over financial reporting is not intended
to provide absolute assurance that we would prevent or detect a misstatement of our financial
statements or fraud. Any failure to maintain an effective system of internal control over financial
reporting could limit our ability to report financial results accurately and timely or to detect
and prevent fraud. A significant financial reporting failure could cause an immediate loss of
investor confidence and our management and a sharp decline in the market price of our common stock.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Use of Proceeds
Our initial public offering of common stock was effected through a Registration Statement on
Form S-1 (File No. 333-142646), which was declared effective by the Securities and Exchange
Commission on July 25, 2007.
We received net proceeds of $12.4 million from the offering. As of June 30, 2008, $2.1 million
of the net proceeds from the offering was in short-term, interest-bearing, investment-grade
securities and $10.3 million of the proceeds were used to fund SonoLysis development and urokinase
commercialization activities, pay the non-recourse note to Abbott Laboratories and working capital
and other general corporate purposes. The remaining funds may be used for working capital and other
general corporate purposes.
Item 4. Submission of Matters to a Vote of Security Holders.
On May 29, 2008 we held our Annual Meeting of Stockholders. The following proposals were the
only matters submitted for approval at the meeting:
Proposal 1: To elect the following slate of individuals to serve as the directors of the company
until the next annual meeting of stockholders or until each persons successor is duly qualified
and elected:
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Nominees |
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For |
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Withheld |
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Richard Love |
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6,480,626 |
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360,086 |
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Richard Otto |
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6,456,179 |
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384,533 |
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Thomas W. Pew |
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6,476,626 |
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364,086 |
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Philip Ranker |
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6,477,606 |
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363,100 |
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James M. Strickland |
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6,464,021 |
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376,691 |
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Bradford Zakes |
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6,452,559 |
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388,153 |
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Proposal 2: To ratify the appointment of Ernst & Young LLP as our independent registered public
accounting firm for the fiscal year ending December 31, 2008.
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For: |
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Against: |
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Abstain: |
6,783,244
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15,747
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41,721 |
21
Item 6. Exhibits.
Exhibit Index
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Incorporated by Reference |
Exhibit |
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Filed |
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Exhibit |
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No |
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Exhibit Title |
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Herewith |
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Form |
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No. |
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File No. |
|
Filing Date |
|
10.1 |
|
|
Amendment No. 3 to
Executive
Employment
Agreement dated as
of June 27, 2008 by
and between the
Company and
Bradford A. Zakes
|
|
|
|
8-K
|
|
|
10.1 |
|
|
001-33043
|
|
July 1, 2008 |
|
10.2 |
|
|
Termination
Agreement dated as
of June 10, 2008 by
and between the
Company and
Microbix Biosystems
Inc.
|
|
|
|
8-K
|
|
|
10.1 |
|
|
001-33043
|
|
June 12, 2008 |
|
10.3 |
|
|
Separation and
Release of Claims
Agreement by and
between the Company
and Greg Cobb
|
|
|
|
8-K
|
|
|
10.2 |
|
|
001-33043
|
|
June 12, 2008 |
|
10.4 |
|
|
Consultant Services
Agreement dated as
of June 11, 2008 by
and between the
Company and Greg
Cobb
|
|
|
|
8-K
|
|
|
10.3 |
|
|
001-33043
|
|
June 12, 2008 |
|
10.5 |
|
|
Separation and
Release of Claims
Agreement by and
between the Company
and Kevin Ontiveros
|
|
|
|
8-K
|
|
|
10.4 |
|
|
001-33043
|
|
June 12, 2008 |
|
10.6 |
|
|
Consultant Services
Agreement dated as
of June 11, 2008 by
and between the
Company and Kevin
Ontiveros
|
|
|
|
8-K
|
|
|
10.5 |
|
|
001-33043
|
|
June 12, 2008 |
|
10.7 |
|
|
Letter of Intent
between ImaRx
Therapeutics, Inc.
and Microbix
Biosystems Inc.,
dated May 6, 2008.
|
|
|
|
8-K
|
|
|
10.1 |
|
|
001-33043
|
|
May 7, 2008 |
|
10.8 |
|
|
Satisfaction,
Waiver and Release
Agreement, dated
April 17, 2008, by
and between ImaRx
Therapeutics, Inc.
and Abbott
Laboratories.
|
|
|
|
8-K
|
|
|
10.1 |
|
|
001-33043
|
|
April 23, 2008 |
|
31.1 |
|
|
Rule
13a-14(a)/15d-14(a)
Certification of
Chief Executive
Officer
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
31.2 |
|
|
Rule
13a-14(a)/15d-14(a)
Certification of
Principal Financial
Officer
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
32 |
|
|
Section 1350
Certification of
Periodic Financial
Report by the Chief
Executive Officer
and Principal
Financial and
Accounting Officer
|
|
X |
|
|
|
|
|
|
|
|
|
|
22
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
|
|
|
|
|
IMARX THERAPEUTICS, INC.
|
|
Date: August 14, 2008 |
By: |
/s/ Bradford A. Zakes
|
|
|
|
Bradford A. Zakes, |
|
|
|
President and Chief Executive Officer
(Principal Executive Officer and Principal Financial Officer) |
|
|
23
EXHIBIT INDEX
Exhibit Index
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incorporated by Reference |
Exhibit |
|
|
|
Filed |
|
|
|
Exhibit |
|
|
|
|
No |
|
Exhibit Title |
|
Herewith |
|
Form |
|
No. |
|
File No. |
|
Filing Date |
|
10.1 |
|
|
Amendment No. 3 to
Executive
Employment
Agreement dated as
of June 27, 2008 by
and between the
Company and
Bradford A. Zakes
|
|
|
|
8-K
|
|
|
10.1 |
|
|
001-33043
|
|
July 1, 2008 |
|
10.2 |
|
|
Termination
Agreement dated as
of June 10, 2008 by
and between the
Company and
Microbix Biosystems
Inc.
|
|
|
|
8-K
|
|
|
10.1 |
|
|
001-33043
|
|
June 12, 2008 |
|
10.3 |
|
|
Separation and
Release of Claims
Agreement by and
between the Company
and Greg Cobb
|
|
|
|
8-K
|
|
|
10.2 |
|
|
001-33043
|
|
June 12, 2008 |
|
10.4 |
|
|
Consultant Services
Agreement dated as
of June 11, 2008 by
and between the
Company and Greg
Cobb
|
|
|
|
8-K
|
|
|
10.3 |
|
|
001-33043
|
|
June 12, 2008 |
|
10.5 |
|
|
Separation and
Release of Claims
Agreement by and
between the Company
and Kevin Ontiveros
|
|
|
|
8-K
|
|
|
10.4 |
|
|
001-33043
|
|
June 12, 2008 |
|
10.6 |
|
|
Consultant Services
Agreement dated as
of June 11, 2008 by
and between the
Company and Kevin
Ontiveros
|
|
|
|
8-K
|
|
|
10.5 |
|
|
001-33043
|
|
June 12, 2008 |
|
10.7 |
|
|
Letter of Intent
between ImaRx
Therapeutics, Inc.
and Microbix
Biosystems Inc.,
dated May 6, 2008.
|
|
|
|
8-K
|
|
|
10.1 |
|
|
001-33043
|
|
May 7, 2008 |
|
10.8 |
|
|
Satisfaction,
Waiver and Release
Agreement, dated
April 17, 2008, by
and between ImaRx
Therapeutics, Inc.
and Abbott
Laboratories.
|
|
|
|
8-K
|
|
|
10.1 |
|
|
001-33043
|
|
April 23, 2008 |
|
31.1 |
|
|
Rule
13a-14(a)/15d-14(a)
Certification of
Chief Executive
Officer
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
31.2 |
|
|
Rule
13a-14(a)/15d-14(a)
Certification of
Principal Financial
Officer
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
32 |
|
|
Section 1350
Certification of
Periodic Financial
Report by the Chief
Executive Officer
and Principal
Financial and
Accounting Officer
|
|
X |
|
|
|
|
|
|
|
|
|
|
24