e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2008.
or
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to .
Commission File Number: 000-23017
ECHO 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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41-1649949
(I.R.S. Employer Identification Number) |
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10 Forge Parkway, Franklin, MA
(Address of principal executive offices)
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02038
(Zip code) |
(508) 553-8850
(Registrants telephone number, including area code)
(Former
name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o | Accelerated filer o | Non-accelerated filer o (Do not check if a smaller reporting company) | Smaller reporting company þ |
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
As of August 5, 2008, 18,751,933 shares of the registrants Common Stock. $0.01 par value,
were issued and outstanding.
PART IFINANCIAL INFORMATION
Item 1. Consolidated Financial Statements.
Echo Therapeutics, Inc.
(Formerly Sontra Medical Corporation)
Consolidated Balance Sheets
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As of, |
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June 30, |
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December 31, |
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2008 |
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2007 |
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(Unaudited) |
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(Audited) |
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ASSETS |
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Current Assets: |
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Cash and cash equivalents |
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$ |
1,315,901 |
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$ |
1,193,163 |
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Prepaid expenses and other current assets |
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63,309 |
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25,263 |
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Total current assets |
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1,379,210 |
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1,218,426 |
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Property and Equipment, at cost: |
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Computer equipment |
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240,207 |
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233,946 |
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Office and laboratory equipment |
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607,193 |
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588,498 |
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Furniture and fixtures |
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14,288 |
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14,288 |
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Manufacturing equipment |
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129,320 |
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197,888 |
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Leasehold improvements |
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177,768 |
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177,768 |
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1,168,776 |
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1,212,388 |
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Less-Accumulated depreciation and amortization |
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(1,075,131 |
) |
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(1,100,507 |
) |
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Net property and equipment |
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93,645 |
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111,881 |
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Other Assets: |
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Restricted cash |
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10,250 |
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10,250 |
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Intangible assets, net of accumulated amortization |
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9,886,320 |
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9,945,486 |
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Deferred financing costs, net of amortization |
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519,058 |
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Deposits and other assets |
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2,000 |
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2,000 |
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Total other assets |
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10,417,628 |
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9,957,736 |
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Total assets |
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$ |
11,890,483 |
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$ |
11,288,043 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current Liabilities: |
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Accounts payable |
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$ |
425,965 |
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$ |
382,308 |
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Current portion of notes payable, net of discounts |
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1,784,113 |
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386,458 |
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Accrued expenses |
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711,608 |
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451,136 |
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Total current liabilities |
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2,921,686 |
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1,219,902 |
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Notes Payable, net of current portion and discounts |
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1,816,505 |
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Commitments |
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Stockholders Equity: |
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Series A Convertible Preferred Stock, $0.01 par value, authorized 10,000,000 and
7,000,000 shares, none issued and outstanding at June 30, 2008 and
December 31, 2007, respectively |
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Common stock, $0.01 par value, authorized 60,000,000 shares, issued and outstanding
18,742,468 shares and 17,870,804 shares at June 30, 2008 and December 31, 2007,
respectively |
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187,427 |
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178,710 |
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Additional paid-in capital |
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60,937,361 |
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57,575,593 |
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Accumulated deficit |
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(53,972,496 |
) |
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(47,686,162 |
) |
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Total stockholders equity |
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7,152,292 |
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10,068,141 |
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Total liabilities and stockholders equity |
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$ |
11,890,483 |
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$ |
11,288,043 |
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The
accompanying notes are an integral part of these consolidated financial statements.
2
Echo
Therapeutics, Inc.
(Formerly
Sontra Medical Corporation)
Consolidated
Statements of Operations
(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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Revenue: |
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Product revenue |
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$ |
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$ |
2,353 |
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$ |
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$ |
12,120 |
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Licensing revenue |
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12,500 |
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25,000 |
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Total revenue |
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14,853 |
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37,120 |
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Operating Expenses: |
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Cost of product revenue |
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1,556 |
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Research and development |
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771,699 |
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340,488 |
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1,541,906 |
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600,093 |
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Selling, general and administrative |
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1,213,966 |
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692,475 |
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2,404,384 |
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1,044,415 |
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Total operating expenses |
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1,985,665 |
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1,032,963 |
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3,946,290 |
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1,646,064 |
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Loss from operations |
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(1,985,665 |
) |
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(1,018,110 |
) |
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(3,946,290 |
) |
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(1,608,944 |
) |
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Other Income (Expense): |
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Interest income |
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6,607 |
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7,580 |
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17,075 |
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13,906 |
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Interest expense |
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(278,157 |
) |
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(3,699 |
) |
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(558,390 |
) |
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(6,157 |
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Loss on extinguishment of debt |
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(1,212,013 |
) |
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Derivatives loss |
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(48,018 |
) |
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(586,716 |
) |
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Other income (expense), net |
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(319,568 |
) |
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3,881 |
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(2,340,044 |
) |
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7,749 |
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Net loss |
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(2,305,233 |
) |
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(1,014,229 |
) |
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(6,286,334 |
) |
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(1,601,195 |
) |
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Accretion of dividend on Series A Convertible
Preferred Stock |
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(483 |
) |
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Net loss applicable to common shareholders |
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$ |
(2,305,233 |
) |
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$ |
(1,014,229 |
) |
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$ |
(6,286,334 |
) |
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$ |
(1,601,678 |
) |
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Net loss per common share, basic and diluted |
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$ |
(0.12 |
) |
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$ |
(0.11 |
) |
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$ |
(0.34 |
) |
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$ |
(0.19 |
) |
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Basic and diluted weighted average common shares outstanding |
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18,543,955 |
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9,638,869 |
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18,429,319 |
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8,415,572 |
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The
accompanying notes are an integral part of these consolidated financial statements.
3
Echo
Therapeutics, Inc.
(Formerly Sontra Medical Corporation)
Consolidated Statements of Cash Flows
(Unaudited)
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Six Months Ended |
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June 30, |
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2008 |
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2007 |
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Cash Flows From Operating Activities: |
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Net loss |
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$ |
(6,286,334 |
) |
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$ |
(1,601,195 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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102,358 |
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60,299 |
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Share-based compensation |
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990,183 |
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|
510,848 |
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Fair value of common stock and warrants issued for services |
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353,610 |
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Derivative loss |
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586,716 |
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Loss on extinguishment of debt |
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1,212,013 |
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Non-cash interest expense |
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502,451 |
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Changes in assets and liabilities: |
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Inventory |
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1,556 |
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Prepaid expenses and other current assets |
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(38,046 |
) |
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(56,112 |
) |
Accounts payable |
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43,657 |
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86,041 |
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Deferred revenue |
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(25,000 |
) |
Accrued expenses |
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299,315 |
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90,499 |
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Net cash used in operating activities |
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(2,234,077 |
) |
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(933,064 |
) |
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Cash Flows from Investing Activities: |
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Purchase of property and equipment |
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(24,956 |
) |
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Decrease (Increase) in restricted cash |
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9,699 |
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Net cash used in investing activities |
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(24,956 |
) |
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|
9,699 |
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Cash Flows From Financing Activities |
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Repurchase of Series A preferred stock |
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(73,334 |
) |
Proceeds from the sale of common stock, net of expenses |
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1,724,969 |
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Proceeds from Senior Convertible Notes and Warrants |
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700,000 |
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Proceeds from Secured Notes and Warrants |
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2,000,000 |
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Deferred financing costs |
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(432,309 |
) |
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Payments on equipment note payable |
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(59,287 |
) |
Proceeds from the exercise of warrants |
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114,080 |
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30,187 |
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Net cash provided by financing activities |
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2,381,771 |
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1,622,535 |
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Net Increase in Cash and Cash Equivalents |
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|
122,738 |
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|
699,170 |
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Cash and Cash Equivalents, beginning of period |
|
$ |
1,193,163 |
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$ |
559,017 |
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Cash and Cash Equivalents, end of period |
|
$ |
1,315,901 |
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|
$ |
1,258,187 |
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Supplemental Disclosure of Cash Flow Information and Non Cash Financing
Transactions: |
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Cash paid for interest |
|
$ |
9,459 |
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|
$ |
2,765 |
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Accretion of dividend on Series A Convertible Preferred Stock |
|
$ |
|
|
|
$ |
483 |
|
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|
Common stock issued for dividends on Series A Convertible Preferred Stock |
|
$ |
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|
$ |
3,440 |
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Common stock issued for conversion of Senior Convertible Notes and accrued
interest |
|
$ |
52,041 |
|
|
$ |
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Fair value of common stock issued for financing costs |
|
$ |
|
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|
$ |
103,572 |
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Fair value of common stock issued for deferred financing costs |
|
$ |
185,668 |
|
|
$ |
|
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|
Beneficial conversion feature on Senior Convertible Notes |
|
$ |
121,320 |
|
|
$ |
|
|
|
|
|
|
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|
Fair value of warrants issued in connection with Senior Convertible Notes
included in extinguishment loss |
|
$ |
626,480 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
Adjustment to fair value of Bridge Notes exchanged for Senior Convertible
notes
included in extinguishment loss |
|
$ |
585,533 |
|
|
$ |
|
|
|
|
|
|
|
|
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|
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|
Intrinsic value of the conversion feature of the Bridge Notes when converted
to
Senior Convertible Notes recorded as a reduction of additional paid-in capital |
|
$ |
212,328 |
|
|
$ |
|
|
|
|
|
|
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|
Relative fair value of warrants issued with Secured Notes |
|
$ |
219,838 |
|
|
$ |
|
|
|
|
|
|
|
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|
Reclassification of derivative liability to additional paid-in capital |
|
$ |
919,593 |
|
|
$ |
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
4
ECHO THERAPEUTICS, INC.
(Formerly Sontra Medical Corporation)
Notes to Consolidated Financial Statements
Period Ended June 30, 2008
(Unaudited)
(1) ORGANIZATION, BASIS OF PRESENTATION AND GOING CONCERN
Organization and Basis of Presentation
Echo Therapeutics, Inc. is a transdermal medical device and specialty pharmaceutical company
developing a non-invasive (needle-free), wireless, transdermal continuous glucose monitoring (tCGM)
system for people with diabetes and for use in hospital critical care units and a wide range of
topical reformulations of pharmaceutical products previously approved by the United States Food and
Drug Administration (FDA).
Echo Therapeutics, Inc. was formed through the merger of a wholly-owned subsidiary of Sontra
Medical Corporation and Durham Pharmaceuticals Ltd. (doing business
as Echo Therapeutics, Inc. (Durham)) in
September 2007 (the Merger). Previously, Durham was a majority-owned
subsidiary of Cato Holding Company (doing business as Cato
BioVentures). Effective October
8, 2007, Sontra Medical Corporation, a Minnesota corporation, changed its name to Echo
Therapeutics, Inc. (Echo-MN)
On June 9, 2008, Echo-MN entered into an Agreement and Plan of Merger (the Merger Agreement)
with a wholly-owned subsidiary of the same name, Echo Therapeutics, Inc., a Delaware corporation
(Echo-DE), in order to change Echo-MNs state of incorporation from Minnesota to Delaware (the
Merger). The Merger Agreement and Merger were approved by Echo-MNs shareholders at Echo-MNs
Annual Meeting of the Shareholders on May 20, 2008. Pursuant to the Merger Agreement, Echo-MN
merged with and into Echo-DE and Echo-DE is the surviving corporation (the Company).
Each share of common stock, par value $0.01 per share, of Echo-MN that was issued and
outstanding immediately prior to the Merger was converted into one issued and outstanding share of
common stock, par value $0.01 per share, of the Company (Common Stock), so that the holders of
all of the issued and outstanding shares of common stock of Echo-MN immediately prior to the Merger
became the holders of Common Stock of the Company upon the effectiveness of the Merger.
The accompanying unaudited consolidated financial statements have been prepared in conformity
with generally accepted accounting principles in the United States (GAAP) consistent with those
applied in, and should be read in conjunction with, the Companys audited financial statements and
related footnotes for the year ended December 31, 2007 included in the Companys Annual Report on
Form 10-KSB as filed with the United States Securities and Exchange Commission (SEC) on March 31,
2008. The unaudited consolidated financial statements reflect all adjustments, consisting only of
normal recurring adjustments, which are, in the opinion of management, necessary for a fair
presentation of the Companys financial position as of June 30, 2008 and its results of operations
and cash flows for the interim periods presented and are not necessarily indicative of results for
subsequent interim periods or for the full year. The interim financial statements do not include
all of the information and footnotes required by GAAP for complete financial statements and allowed
by the relevant SEC rules and regulations. However, the Company believes that its disclosures are
adequate to ensure that the information presented is not misleading.
The accompanying consolidated financial statements include the accounts of the Company and its
wholly-owned subsidiary, Sontra Medical Inc., a Delaware corporation. All significant inter-company
balances and transactions have been eliminated in the consolidated financial statements.
The accompanying consolidated financial statements have been prepared on a going concern
basis, which contemplates the realization of assets and the satisfaction of liabilities in the
normal course of business. As of June 30, 2008, the Company had cash of approximately $1,316,000
and an accumulated deficit of approximately $54,000,000. Through June 30, 2008, the Company had no
sales or revenues to cover its costs and operating expenses. Although the Company has been able to
issue securities through
senior promissory notes, secured promissory notes and a series of private placements to raise
capital in order to fund its operations, it is not known whether the Company will be able to
continue this practice, or be able to obtain other types of financing to meet its cash operating
expenses. This, in turn, raises substantial doubt about the Companys ability to continue as a
going concern. Management is currently pursuing additional private equity financing, and such
financing is expected to be completed during 2008. However, no assurances can be given as to the
success of these plans. The consolidated financial statements do not include any adjustments that
might result from the outcome of these uncertainties.
5
(2) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The accompanying financial statements reflect the application of the following accounting
policies:
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make
judgments, estimates and assumptions that affect the amounts reported in the Companys consolidated
financial statements and accompanying notes. Actual results could differ materially from those
estimates. The Company considers the valuation of intangible assets, the recoverability of
long-lived assets, the realizability of deferred tax assets and the fair value of share-based
payments issued to be material accounting estimates.
Intangible Assets and Other Long-Lived Assets
The Company records intangible assets at the acquisition date fair value. As a policy, the
Company amortizes its intangible assets using the straight-line method over their estimated useful
lives, as follows: patents and licenses, two to 20 years; definite-lived core and developed
technology, five to 25 years; and other intangible assets over various periods. In connection with
the acquisition of Durham Pharmaceuticals Ltd., intangible assets related to contractual
arrangements and technology are amortized over estimated useful lives of three (3) and nine (9)
years, respectively, on a straight-line basis.
In accordance with Financial Accounting Standards Board (FASB) Statement of Financial
Accounting Standards (SFAS) No. 144, Accounting for the Impairment and Disposal of Long-Lived
Assets, the Company reviews intangible assets subject to amortization quarterly to determine if any
adverse conditions exist or a change in circumstances has occurred that would indicate impairment
or a change in the remaining useful life of any intangible asset. Conditions that would indicate
impairment and trigger an impairment assessment include, but are not limited to, a significant
adverse change in legal factors or business climate that could affect the value of an asset, or an
adverse action or assessment by a regulator. If the carrying value of an asset exceeds its
undiscounted cash flows, the Company writes-down the carrying value of the intangible asset to its
fair value in the period identified.
The Company generally calculates fair value as the present value of estimated future cash
flows it expects to generate from the asset using a risk-adjusted discount rate. If the estimate of
an intangible assets remaining useful life is changed, the Company amortizes the remaining
carrying value of the intangible asset prospectively over the revised remaining useful life.
For other long-lived assets, the Company evaluates quarterly whether events or circumstances
have occurred that indicate that the carrying value of these assets may be impaired. No impairment
losses were recorded for the six months ended June 30, 2008.
Share-Based Payments
Under SFAS No. 123R, the Company recognizes compensation costs resulting from the issuance of
stock-based awards to employees and directors as an expense in the statement of operations over the
service period based on a measurement of fair value for each stock award.
The Companys policy is to grant employee and director stock options with an exercise price
equal to the fair value of the Companys common stock at the date of grant.
Derivative Instruments
The Company generally does not use derivative instruments to hedge exposures to cash-flow or
market risks. However, certain warrants to purchase common stock that are indexed to the Companys
common stock are classified as liabilities when the Company is not permitted to settle the
instruments in unregistered shares. In such instances, in accordance with EITF Issue No. 00-19,
net-cash settlement is assumed for financial reporting purposes, even when the terms of the
underlying contracts do not provide for a net-cash settlement. Such financial instruments are
initially recorded at relative fair value with subsequent changes in fair value charged (credited)
to operations in each reporting period. If the Company subsequently achieves the ability to settle
the instruments in unregistered shares, the instruments are reclassified to equity at their fair
value.
On March 24, 2008, the Company entered into a registration rights agreement pursuant to which
the Company agreed to file a registration statement with the Securities and Exchange Commission
covering the resale of the common stock issuable upon exercise of warrants issued to Imperium
Master Fund, Ltd. (Imperium) within 60 days after issuance of the securities. The Company also
agreed to use its best efforts to cause the registration statement to become effective under the
Securities
6
Act as soon as practicable after filing the registration statement, but in no event
later than 180 days after issuance of the Imperium Warrants. As of May 14, 2008, the Company and
Imperium executed Amendment No. 1 to the Registration Rights Agreement to eliminate these
registration requirements and, as a result, the related warrants were no longer required to be
recorded as a derivative liability (see Note 5).
Reclassifications
Certain comparative amounts have been reclassified to correspond with the current years
presentation.
Recent Accounting Pronouncements
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements. SFAS No. 157
defines fair value, establishes a framework for measuring fair value in generally accepted
accounting principles, and expands disclosures about fair value measurements. The pronouncement is
applicable in cases when assets or liabilities are to be measured at fair value. It does not
establish new circumstances in which fair value would be used to measure assets or liabilities. The
provisions of SFAS No. 157 are effective for fiscal years commencing after November 15, 2007. The
adoption of SFAS No. 157 did not have a material impact on the Companys consolidated financial
statements.
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets
and Financial Liabilities Including an Amendment of FASB Statement
No. 115. SFAS No. 159 permits
entities to choose to measure many financial instruments and certain other items at fair value. The
objective is to improve financial reporting by providing entities with the opportunity to mitigate
volatility in reported earnings caused by measuring related assets and liabilities differently
without having to apply complex hedge accounting provisions. This statement is expected to expand
the use of fair value measurement, which is consistent with the FASBs long-term measurement
objectives for accounting for financial instruments. The fair value option permits the Company to
choose to measure eligible items at fair value at specified election dates. The Company will record
unrealized gains and losses on items for which the fair value option has been elected through net
income in the statement of operations at each subsequent reporting date. SFAS No. 159 is effective
as of the beginning of an entitys first fiscal year that begins after November 15, 2007, which is
fiscal year 2008 for the Company. The adoption of SFAS No. 159 did not have a material impact on
the Companys consolidated financial statements.
In December 2007, the FASB issued Statement No. 141 (revised) (No. 141 R), Business
Combinations. This Statement replaces FASB Statement No. 141, and applies to all business entities
that previously used the pooling-of-interests method of accounting for some business combinations.
Under Statement No. 141R, an acquirer is required to recognize, at fair value, the assets acquired,
liabilities assumed, and any non-controlling interest in the entity acquired at the acquisition
date. Further, it requires that acquisition costs and expected restructuring costs be recognized
separately from the acquisition, and that the acquirer, in a business combination executed in
stages, recognizes the identifiable assets and
liabilities as well as the non-controlling interest in the entity acquired, at the full
amounts of their fair values. SFAS No. 141R also requires an acquirer to recognize the assets
acquired and liabilities assumed arising from contractual contingencies as of the acquisition date.
Also under this statement, an acquirer is required to recognize contingent consideration as of the
acquisition date and eliminates the concept of negative goodwill and requires gain recognition in
instances in which the fair value of the identifiable net assets exceeds the fair value of the
consideration plus any non-controlling interest in the entity acquired as of the acquisition date.
SFAS No. 141R makes significant amendments to other Statements and other authoritative guidance,
and applies prospectively to business combinations on or after the acquiring entities first fiscal
year that begins after December 15, 2008, which is fiscal year 2009 for the Company. It may not be
applied prior to that date.
In March of 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and
Hedging Activities, an amendment of FASB Statement No. 133. SFAS No. 161 changes the disclosure
requirements for derivative instruments and hedging activities. Entities are now required to
provide enhanced disclosures about (a) how and why an entity uses derivative instruments, (b) how
derivative instruments and related hedged items are accounted for under SFAS 133 and its related
interpretations, and (c) how derivative instruments and related hedged items affect the entitys
financial position, financial performance, and cash flows. SFAS No. 161 is effective for fiscal
years and interim periods beginning after November 15, 2008 and is not expected to have a material
impact on the consolidated financial statements of the Company.
(3) ACQUISITION OF DURHAM PHARMACEUTICALS LTD.
The Company completed the acquisition of Durham (the Durham Acquisition) on September 14, 2007. Durham was a
development-stage company focused on a broad portfolio of advanced topical reformulations of
widely-used, FDA-approved pharmaceutical products using AzoneTS, its proprietary
transdermal drug delivery technology platform. Durhams lead AzoneTS-reformulated
7
pharmaceutical product candidate is Durhalieve, an advanced reformulation of
triamcinolone acetonide for the treatment of corticosteroid responsive dermatoses. Durhalieve is
covered by a pending New Drug Application on file with the FDA.
(4) INTANGIBLE ASSETS
As of June 30, 2008, intangible assets related to the Durham Acquisition are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated |
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Life |
|
|
Cost |
|
|
Amortization |
|
|
Net |
|
Contract related intangible asset: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cato Research discounted contract |
|
3 years |
|
$ |
355,000 |
|
|
$ |
93,680 |
|
|
$ |
261,320 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Technology related intangible assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patent for the AzoneTS-based product
candidates and formulation |
|
9 years |
|
|
1,305,000 |
|
|
|
|
|
|
|
1,305,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug Master Files containing formulation,
clinical and safety documentation used by
the FDA |
|
9 years |
|
|
1,500,000 |
|
|
|
|
|
|
|
1,500,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Two(2) in-process Durhalieve-related
pharmaceutical products |
|
9 years |
|
|
6,820,000 |
|
|
|
|
|
|
|
6,820,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total technology related intangible assets |
|
|
|
|
|
|
9,625,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
$ |
9,980,000 |
|
|
$ |
93,680 |
|
|
$ |
9,886,320 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization expense was approximately $30,000 and $59,000 for the three months and six months
ended June 30, 2008. There was no amortization expense for the three months and six months ended
June 30, 2007. Amortization expense is included in research and development in the Statement of
Operations.
(5) NOTES PAYABLE
Notes payable at June 30, 2008 and December 31, 2007 consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Senior Secured Notes |
|
$ |
2,209,426 |
|
|
$ |
|
|
Unamortized discounts |
|
|
(425,313 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,784,113 |
|
|
|
|
|
|
|
|
|
|
|
|
Senior Convertible Notes |
|
|
2,309,231 |
|
|
|
|
|
Unamortized discount |
|
|
(492,726 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,816,505 |
|
|
|
|
|
|
|
|
|
|
|
|
Senior Promissory Bridge Notes |
|
|
|
|
|
|
1,325,000 |
|
Unamortized discount |
|
|
|
|
|
|
(938,542 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
386,458 |
|
|
|
|
|
|
|
|
Total notes payable |
|
|
3,600,618 |
|
|
|
386,458 |
|
Less current portion of notes payable |
|
|
1,784,113 |
|
|
|
386,458 |
|
|
|
|
|
|
|
|
|
Notes payable, net of current portion |
|
$ |
1,816,505 |
|
|
$ |
|
|
|
|
|
|
|
|
|
2008 Senior Secured Note and Warrant Financing
On March 24, 2008, the Company entered into a secured note financing agreement with Imperium,
providing for, at the Companys option, the issuance of up to an aggregate $2,000,000 of original
issue discount senior secured notes (the Secured Notes) in up to four equal tranches, together
with warrants (the Imperium Warrants) to purchase up to 634,920 shares of common stock at an
exercise price of $2.00 per share. On March 24, 2008, the Company drew down the initial $500,000 in
gross proceeds and issued the Imperium Warrants upon execution of the agreement. The Company also
issued additional Secured Notes and drew down $500,000 in gross proceeds on each of April 24, 2008,
June 2, 2008 and June 24, 2008, completing the financing for $2,000,000.
8
The Company is not required to make monthly cash payments of principal and interest under the
Secured Notes. Instead, the outstanding principal of each Secured Note will accrete in value at an
annual rate of 10%, compounded monthly, resulting in a total principal amount of approximately
$552,357 due for each Secured Note at maturity. If, however, the Company completes an equity
issuance in one or more series of transactions totaling $5,000,000 (a Qualified Issuance), then
the aggregate amount due for each Secured Note will be reduced from $552,357 to $546,903 and the
annual accretion value will be reduced from 10% to 9%.
Each Secured Note is due twelve months after the date of its issuance, provided, however, that
if the Company completes a Qualified Issuance by October 31, 2008, the Company has a right to
extend the maturity date of each Secured Note to 24 months after the date of its issuance. The
Company has the right to repay the principal amount of the Secured Notes in cash, in whole, but not
in part, prior to maturity at a premium of 1.02 times the unpaid principal plus any other amount
due under the Secured Notes.
Events of default under the Secured Notes include: (1) failure to make a payment when due or
payable; (2) a breach or notice of intent to breach of any material term, covenant or condition in
the Secured Note or any of the transaction documents and such breach is not cured within five
business days after notice; (3) any false, incorrect or breach in any material respect of any
material representation or warranty made by the Company in the transaction documents; (4) the
default of more than $25,000 of any other of the Companys indebtedness that causes such amount to
become due and payable; or (5) a bankruptcy (whether voluntary or involuntary) or general
assignment for the benefit of the Companys creditors. All amounts outstanding under the Secured
Notes, plus an amount equal to the product of 1.10 and all amounts outstanding under the Secured
Notes, become due and payable upon the occurrence of an event of default or upon a change in
control (as defined in the Secured Notes).
In addition, the Company has agreed to certain covenants, including a prohibition on the
ability to incur future indebtedness (subject to certain exceptions) or make any dividend or
payment to holders of its capital stock (other than shares of the class of stock held by such
recipient), and a requirement that the Company maintain $6.5 million in stockholders equity
(excluding any impact of the issuance of the Imperium Warrants to stockholders equity) for so long
as the Secured Notes remain outstanding. The Company also agreed that it may not redeem its Senior
Convertible Notes (discussed below) as long as the Secured Notes remain outstanding, unless it
receives at least $10 million in gross proceeds from an issuance or series of related issuances of
equity securities.
The Companys subsidiary, Sontra Medical, Inc., has guaranteed the obligations under the
Secured Notes. Additionally, the Secured Notes are secured by all of the Companys assets.
The Imperium Warrants have a term of five years and are immediately exercisable at an exercise
price of $2.00 per share. The Imperium Warrants provide for weighted average anti-dilution
protection upon future issuances or deemed issuances (subject to customary exceptions) below the
exercise price. The Imperium Warrants also allow for cashless exercise unless the shares underlying
the warrants are registered for resale on a registration statement filed under the Securities Act
of 1933, as amended (the Securities Act).
In connection with the issuance of the Secured Notes and Imperium Warrants, on March 24, 2008,
the Company and Imperium entered into a Registration Rights Agreement (the Registration Rights
Agreement) pursuant to which the Company agreed to file a registration statement with the SEC
covering the resale of the common stock issuable upon exercise of the Imperium Warrants within 60
days after issuance of the securities. The Company also agreed to use its best efforts to cause the
registration statement to become effective under the Securities Act as soon as practicable after
the filing of the registration statement, but in no event later than 180 days after issuance of the
Imperium Warrants. As of May 14, 2008, the Company and Imperium executed Amendment No. 1 to the
Registration Rights Agreement that eliminated the requirement for registration of the underlying
securities, but granted the holders of the Imperium Warrants piggy-back registration rights with
respect to certain registration statement filings by the Company in the future.
Due to certain requirements to obtain and maintain an effective registration statement
covering the shares underlying the Imperium Warrants, the Company originally determined that the
Imperium Warrants did not meet the requirements for classification as equity as described in EITF
Issue No. 00-19, Accounting for Derivative Financial Instruments Indexed to, and Potentially
Settled in, a Companys Own Stock as of March 31, 2008. As a result, the fair value of the
Imperium Warrants was recorded as a derivative liability which resulted in the recognition of a
derivative loss upon issuance in the amount of approximately $569,000. As a result of the
execution of Amendment No. 1 to the Registration Rights Agreement, the Company determined that the
Imperium Warrants met the requirements for classification as equity as described in EITF Issue No.
00-19 as of May 14, 2008. The derivative liability was adjusted to fair value as of May 14, 2008
resulting in an additional derivative loss of approximately $17,000. The remaining derivative
liability of $919,593 was reclassified to
9
additional paid-in capital. The derivative loss amounted
to approximately $48,000 and $587,000 for the three months and the six months ended June 30, 2008,
respectively.
Interest expense related to the Secured Notes in the three and six months ended June 30, 2008,
including amortization of discounts and deferred financing costs, was approximately $144,000 and
$154,000, respectively. During the three and six months ended June 30, 2008, interest expense was
satisfied by the issuance of additional convertible promissory notes in the amount of zero and
$16,772, respectively.
2007 and 2008 Senior Promissory Bridge Notes and Senior Convertible Notes
On September 14, 2007, the Company completed a private placement of unsecured Senior
Promissory Bridge Notes (the Bridge Notes) in the aggregate principal amount of $1,325,000 to
Montaur Capital through Platinum Long Term Growth VII, LLC and to other strategic institutional and
individual accredited investors. The Bridge Notes were scheduled to be due September 15, 2008 and
accrued interest at a rate of
10% per annum, with interest payable upon maturity. If the Company had completed a subsequent
equity or equity-linked financing or a combination of equity financings resulting in gross proceeds
to the Company totaling at least $2,500,000 on or before December 15, 2007, inclusive of the Bridge
Notes (a Qualified Financing), then the Bridge Notes would have converted automatically into the
equity securities issued in the Qualified Financing. The terms of the Bridge Notes reflected a 20%
premium in the event of an exchange such that upon an automatic exchange of the Bridge Notes in any
Qualified Financing, the holders of the Bridge Notes would be deemed to have tendered an amount
equal to 120% of the outstanding principal and interest of the Bridge Notes in exchange for the
equity securities issued to such holders in the Qualified Financing. A Qualified Financing was not
completed by December 31, 2007 and accordingly, the holders of the Bridge Notes had one demand
registration right and the Bridge Notes became (1) convertible into shares of common stock at a
ratio determined by dividing the outstanding principal and interest of each Bridge Note by a price
per share equal to the price per share of our most recent equity or equity-linked financing or (2)
exchangeable at a 20% premium for securities issued in any other subsequent equity or equity-linked
financing.
On February 11, 2008, the Company completed an approximately $2.3 million private financing
with substantially all of the holders of the Bridge Notes. The $2,292,459 in aggregate principal
amount of unsecured Senior Convertible Notes issued in the financing (the Senior Convertible
Notes) bear interest annually at a rate of 8.0% per annum and provide the holders with the right
to convert principal into shares of the Companys common stock at $1.35 per share. The conversion
price is subject to weighted average anti-dilution protection, excluding certain customary
exceptions. The Senior Convertible Notes have a three-year term and the Company may elect to make
payments of interest in cash, additional notes, or stock.
Additionally, the investors received warrants to purchase 849,059 shares of common stock at an
exercise price of $1.69 per share for a term of five years. The warrants provide for full
anti-dilution price protection to the holders and allow for cashless exercise.
In connection with the Senior Convertible Note financing, certain holders representing
$1,275,000 face value of Bridge Notes exchanged their Bridge Notes at 120% of the outstanding
principal and interest of the Bridge Notes as payment toward the purchase price of the Senior
Convertible Notes purchased by such holders. Accordingly, the Company issued notes in the Senior
Convertible Note financing in the aggregate principal balance of $1,592,459 to the former holders
of the Bridge Notes upon their surrender of the Bridge Notes, and the Company received gross cash
proceeds in the amount of $700,000 in connection with the financing.
One holder of a Bridge Note with a face value of $50,000 converted the principal and accrued
interest of such Bridge Note into 52,041 shares of the Companys common stock, using a $1.00
conversion price as provided in the terms of the Bridge Notes. This was the last Bridge Note
outstanding, and as such, following its conversion, no Bridge Notes remain outstanding.
The Company has determined that the terms of the Senior Convertible Notes are deemed
substantially different, as described in EITF Issue No. 96-19, Debtors Accounting for a
Modification or Exchange of Debt Instruments, from the terms of the Bridge Notes based on the
change in the fair value of the embedded conversion features. As a result, the Company recorded the
Senior Convertible Notes issued in exchange for the Bridge Notes at fair value on the date of
issuance and recorded a loss on extinguishment of approximately $586,000. An amount equal to the
intrinsic value of the conversion feature of the Bridge Notes as measured on the date of exchange
for the Senior Convertible Notes, or approximately $213,000, was recorded as a reduction in
additional paid-in capital in accordance with EITF Issue No. 98-5, Accounting for Convertible
Securities with Beneficial Conversion Features or Contingently Adjustable Conversion Ratios. The
fair value of the warrants issued to the holders of the Bridge Notes upon conversion into the
Senior Convertible Notes, which the Company estimated to be approximately $626,000, was also
included in the loss on extinguishment. The difference between
10
the fair value and the face value of
the Senior Convertible Notes is being accreted to interest expense over the term of the notes.
The new cash proceeds from the Senior Convertible Notes of $700,000 were allocated between the
notes and the warrants issued in the Senior Convertible Note financing on a relative fair value
basis.
Approximately $220,000 of the proceeds was allocated to the warrants and recorded as
additional paid-in capital and a discount on the Senior Convertible Notes. The Company determined
that the effective conversion price, after allocation of the proceeds, resulted in a beneficial
conversion feature of approximately $121,000 which was recorded as additional paid-in capital and a
further discount on the Senior Convertible Notes. The discounts on the Senior Convertible Notes are
being accreted to interest expense over the term of the notes.
Interest expense related to the Bridge Notes for the three months and six months ended June
30, 2008, including amortization of discounts and deferred financing costs was none and
approximately $197,000, respectively. Interest expense related to the Senior Convertible Notes for
the three months and six months ended June 30, 2008, including amortization of discounts and
deferred financing costs was approximately $133,000 and $206,000, respectively.
(6) Fair Values of Assets and Liabilities
Effective January 1, 2008, the Company adopted SFAS No. 157, Fair Value Measurements, which
provides a framework for measuring fair value under GAAP.
In accordance with SFAS 157, the Company groups its financial assets and financial liabilities
measured at fair value in three levels, based on the markets in which the assets and liabilities
are traded and the reliability of the assumptions used to determine fair value.
Level 1 Quoted prices in active markets for identical assets or liabilities. Level 1
assets and liabilities include debt and equity securities that are traded in an active exchange
market. Valuations are obtained from readily available pricing sources for market transactions
involving identical assets or liabilities.
Level 2 Observable inputs other than Level 1 prices, such as quoted prices for similar
assets or liabilities; quoted prices in markets that are not active; or other inputs that are
observable or can be corroborated by observable market data for substantially the full term of the
assets or liabilities. For example, Level 2 assets and liabilities may include debt securities with
quoted prices that are traded less frequently than exchange-traded instruments.
Level 3 Unobservable inputs that are supported by little or no market activity and that are
significant to the fair value of the assets or liabilities. Level 3 assets and liabilities include
financial instruments whose value is determined using pricing models, discounted cash flow
methodologies, or similar techniques, as well as instruments for which the determination of fair
value requires significant management judgment or estimation. This category includes, for example,
certain private equity investments and long-term derivative contracts.
The only asset or liability measured at fair value on a recurring basis is the Companys
derivative liability and is included in Level 3 in the fair value hierarchy. As a result of the
execution of Amendment No. 1 to the Registration Rights Agreement as described in Note 5, the
remaining liability balance was classified as additional paid-in capital as of May 14, 2008 and the
derivative liability was eliminated at that time. The fair value of the derivative liability at
June 30, 2008 was zero.
The table below presents the changes in Level 3 derivative liability measured at fair value on
a recurring basis.
11
|
|
|
|
|
|
|
Six Months |
|
|
|
ended June 30, |
|
|
|
2008 |
|
|
Balance as of January 1, 2008 |
|
$ |
|
|
|
|
|
|
|
Total realized / unrealized loss
included in net loss |
|
|
17,349 |
(1) |
Purchases, sales, issuances
and settlements |
|
|
902,244 |
|
Reclassification to equity |
|
|
(919,593 |
) |
|
|
|
|
|
|
|
|
|
Balance as of June 30, 2008 |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
Change in unrealized gains/(losses)
relating to instruments
at the reporting date |
|
$ |
|
|
|
|
|
|
|
|
|
(1) |
|
Included in derivative loss on the statement of operations for the six months ended June 30, 2008. |
Also, the Company may be required, from time to time, to measure certain other financial assets at
fair value on a nonrecurring basis. These adjustments to fair value usually result from
application of lower-of-cost-or-market accounting or write-downs of individual assets. In the six
months ended June 30, 2008, there were no such adjustments.
(7) COMMON STOCK
The Company has authorized 60,000,000 shares of common stock, $0.01 par value per share, of
which 18,742,468 and 17,870,804 shares were issued and outstanding as of June 30, 2008 and December
31, 2007, respectively.
Exercise of Warrants
In December 2007, the Company requested from the holders of the warrants issued in January
2007 the right to redeem the outstanding warrants to purchase 1,506,250 shares of the Companys
common stock, $.01 par value, at $0.21 per share, for $0.001 per share. Through June 30, 2008, no
such warrants had been redeemed and warrants to purchase 545,000 shares of common stock were
exercised voluntarily, providing gross proceeds of approximately $114,079. In addition, the Company
issued 160,873 shares of common stock in connection with a cashless exercise of warrants issued in
January 2007 to purchase 181,250 shares of common stock.
Restricted Common Stock issued for Services
On May 23, 2008 and March 25, 2008, the Companys Board of Directors approved the issuance of
100,000 and 25,000, respectively, of fully-vested, unregistered shares of the Companys common
stock to consultants for investor relations services (see Note 8).
(8) STOCK OPTION PLANS
In 1997, the Company adopted its 1997 Long-Term Incentive and Stock Option Plan (the 1997
Plan). Pursuant to the 1997 Plan, the Companys Board of Directors (or committees and/or executive
officers delegated by the Board of Directors) may grant incentive and nonqualified stock options to
the Companys employees, officers, directors, consultants and advisors. The Company has reserved an
aggregate of 150,000 shares of its common stock for issuance upon exercise of options granted under
the 1997 Plan. As of June 30, 2008, there were options to purchase an aggregate of 30,000 shares of
common stock outstanding under the 1997 Plan and 111,546 shares available for future option grants
under the 1997 Plan.
In connection with the Companys strategic merger with ChoiceTel in 2002, the Company assumed all
outstanding options under the 1999 Sontra Medical, Inc. Stock Option and Incentive Plan (the 1999
Plan). The Company may not grant any additional options under the 1999 Plan. The Company assumed
options to purchase an aggregate of 86,567 shares of common
12
stock under the 1999 Plan. As of June 30, 2008, there were options to purchase an aggregate of
5,780 shares of common stock outstanding under the 1999 Plan and none available for future grants.
In March 2003, the Companys shareholders approved its 2003 Stock Option and Incentive Plan
(the 2003 Plan). Pursuant to the 2003 Plan, the Companys Board of Directors (or committees
and/or executive officers delegated by the Board of Directors) may grant incentive and nonqualified
stock options, restricted stock and other stock-based awards to the Companys employees, officers,
directors, consultants and advisors. On May 22, 2007, the shareholders of the Company increased the
number of shares authorized for issuance under the 2003 Plan by 1,000,000 shares. As of June 30,
2008, the maximum aggregate number of shares that may be authorized for issuance under the 2003
Plan for all periods is 1,600,000. As of June 30, 2008, there were restricted shares of common
stock and options to purchase an aggregate of 1,158,616 shares of common stock outstanding under
the 2003 Plan and 428,384 shares available for future grants under the 2003 Plan.
On May 20, 2008, the Companys shareholders approved the Echo Therapeutics, Inc. 2008 Equity
Compensation Plan (the 2008 Plan) at the Companys Annual Meeting of Shareholders. The 2008 Plan
provides for grants of incentive stock options to employees and nonqualified stock options and
restricted stock to employees, consultants and non-employee directors of the Company. As of June
30, 2008, the number of shares authorized for issuance under the 2008 Plan was 1,700,000 shares and
no grants had been made under the 2008 Plan.
Share-Based Compensation
For options and restricted stock issued and outstanding during the six months ended June 30,
2008 and 2007, the Company recorded additional paid-in capital and non-cash compensation expense of
approximately $990,000 and $511,000, respectively, each net of estimated forfeitures.
The fair value of each option award is estimated on the date of grant using the Black-Scholes
option pricing model that uses the assumptions noted in the following table. Expected volatilities
are based on historical volatility of the Companys common stock using historical periods
consistent with the expected term of the options. The Company uses historical data, as well as
subsequent events occurring prior to the issuance of the financial statements, to estimate option
exercise and employee termination within the valuation model. The expected term of options granted
under the Companys stock plans is based on the average of the contractual term (generally 10
years) and the vesting period (generally 36 to 42 months) as permitted under SEC Staff Accounting
Bulletin No. 107 and 110. The risk-free rate is based on the yield of a U.S. Treasury security with
a term consistent with the option. Restricted stock grants are valued based on the closing market
price for the Companys common stock on the grant date.
The assumptions used principally for options granted to employees and members of the Companys
Board of Directors in the six months ended June 30, 2008 and 2007 were as follows:
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
2007 |
Risk-free interest rate |
|
3.99% |
|
4.72% |
Expected dividend yield |
|
|
|
|
|
|
Expected term (employee / director grants) |
|
6.75 years |
|
6.75 years |
Forfeiture rate (excluding fully vested options) |
|
39% |
|
38% |
Expected volatility |
|
154% 157% |
|
118% 163 |
A summary of option activity under the Companys stock plans and options granted to officers
of the Company outside any plan as of June 30, 2008 and changes during the six months then ended is
presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
|
|
|
|
Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
Options |
|
Shares |
|
|
Price |
|
|
Term |
|
|
Value |
|
Outstanding at January 1, 2008 |
|
|
4,066,271 |
|
|
$ |
1.99 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
265,000 |
|
|
|
1.52 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
(183,334 |
) |
|
|
1.58 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2008 |
|
|
4,147,937 |
|
|
$ |
1.98 |
|
|
9.23 years |
|
$ |
1,673,233 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at June 30, 2008 |
|
|
1,755,851 |
|
|
$ |
2.24 |
|
|
9.02 years |
|
$ |
894,982 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13
The weighted-average grant-date fair value of options granted during the six months ended June
30, 2008 was $1.52 per share. Share-based compensation expense recognized in the six months ended
June 30, 2008 was approximately $163,000 for options granted in the six months ended June 30, 2008.
There were no options exercised in the six months ended June 30, 2008.
Restricted Stock Grants
As of June 30, 2008, the Company had outstanding restricted stock grants amounting to 267,875
shares at a weighted-average grant-date fair value of $1.80 per share. Of the outstanding
restricted stock grants, 254,750 shares have not been registered under the Securities Act. A
summary of the status of the Companys nonvested restricted stock grants as of June 30, 2008, and
changes during the six months ended June 30, 2008, is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average |
Nonvested Shares |
|
Shares |
|
Grant-Date Fair Value |
Nonvested at January 1, 2008 |
|
|
16,875 |
|
|
$ |
1.77 |
|
Granted |
|
|
125,000 |
|
|
|
1.76 |
|
Vested |
|
|
(125,000 |
) |
|
|
1.76 |
|
Forfeited |
|
|
(11,250 |
) |
|
|
1.77 |
|
|
|
|
|
|
|
|
|
|
Nonvested at June 30, 2008 |
|
|
5,625 |
|
|
$ |
1.77 |
|
|
|
|
|
|
|
|
|
|
Share-based compensation recognized in the six months ended June 30, 2008 related to
restricted stock grants to directors was approximately $3,000.
On May 23, 2008 and March 25, 2008, the Companys Board of Directors approved the issuance of
100,000 and 25,000, respectively, restricted shares of the Companys common stock to consultants
for investor relations services. The fair value of the services has been determined to be
approximately $182,500 and $37,500, respectively, and was recorded as investor relations expense in
selling, general and administrative expense during the six months ended June 30, 2008.
(9) WARRANTS
At June 30, 2008, the Company had the following outstanding warrants:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
|
|
|
Shares |
|
|
Exercise |
|
|
Date of |
|
|
|
Exercisable |
|
|
Price |
|
|
Expiration |
|
Issued to investors in private placement |
|
|
501,200 |
|
|
$ |
15.00 |
|
|
|
9/15-10/15/2008 |
|
Issued to placement agent in private placement |
|
|
41,059 |
|
|
$ |
12.00 |
|
|
|
9/15-10/15/2008 |
|
Issued to investors and placement agent in private placement |
|
|
118,620 |
|
|
$ |
24.50 |
|
|
|
12/8-10/15/2009 |
|
Issued to investor in former subsidiary |
|
|
15,000 |
|
|
$ |
50.00 |
|
|
|
2/23/2010 |
|
Issued to investors and placement agent in private placement |
|
|
476,829 |
|
|
$ |
5.80 |
|
|
|
3/16/2016 |
|
Issued to investors in private placement |
|
|
611,250 |
|
|
$ |
0.21 |
|
|
|
1/30/09 |
|
Issued to investors and placement agent in private placement |
|
|
599,250 |
|
|
$ |
1.40 |
|
|
|
6/15-7/16/2012 |
|
Issued to financial advisor |
|
|
60,000 |
|
|
$ |
1.61 |
|
|
|
7/25/2012 |
|
Issued to financial advisor in connection with an acquisition |
|
|
425,000 |
|
|
$ |
2.26 |
|
|
|
9/14/2012 |
|
Issued to financial advisor |
|
|
175,013 |
|
|
$ |
1.49 |
|
|
|
2/11/2013 |
|
Issued to Senior Convertible Note holders |
|
|
849,059 |
|
|
$ |
1.69 |
|
|
|
2/11/2013 |
|
Issued to Secured Note holders |
|
|
634,920 |
|
|
$ |
2.00 |
|
|
|
3/14/2013 |
|
Issued to consultant |
|
|
25,000 |
|
|
$ |
2.50 |
|
|
|
3/25/2010 |
|
Issued to consultant |
|
|
80,000 |
|
|
$ |
2.50 |
|
|
|
3/25/2013 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
4,612,201 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average exercise price |
|
|
|
|
|
$ |
4.27 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average duration in years |
|
|
|
|
|
|
|
|
|
3.15 years |
|
|
|
|
|
|
|
|
|
|
|
|
Issuances to Consultants
On March 25, 2008, the Companys Board of Directors approved the issuance of warrants to
purchase 105,000 shares of the Companys common stock at an exercise price of $2.50 per share to
two consultants for investor relations services. The fair value of these services has been
determined to be approximately $133,000.
14
Issuance of Warrants for Financing
On February 11, 2008, the Company provided warrants to purchase 173,013 shares of the
Companys common stock at an exercise price of $1.49 per share to Burnham Hill Partners, a division
of Pali Capital, Inc., for a financing fee in connection with the Senior Convertible Note
financing. The fair value of these services has been determined to be approximately $186,000 and
has been recorded as a deferred financing cost with amortization over a three year period.
Amortization for the six months ended June 30, 2008 amounted to $24,000.
(10) RIGHT OF FIRST OFFER AGREEMENT
On April 21, 2008, the Company entered into a Dermatology Product Candidate Right of First
Offer Agreement (the Right of First Offer Agreement) with Cato BioVentures pursuant to which Cato
BioVentures granted the Company a right of first offer to purchase certain dermatology small
molecule drug or protein biologic product candidates or transdermal drug delivery technologies
which Cato BioVentures owns or licenses, as well as those owned by a third party for which Cato
BioVentures has a right to disclose to the Company (each, an Available Product Candidate). Under the
terms of the Right of First Offer Agreement, Cato BioVentures must promptly notify the Company of
an Available Product Candidate and discuss such Available Product Candidate exclusively with the
Company for a period of at least 90 days. The Company must provide notice of its interest in
pursuing the Available Product Candidate within such 90 day period or the Company will be deemed to
have declined its rights to the Available Product Candidate. The Right of First Offer Agreement
terminates on December 31, 2010 unless the parties mutually agree to extend the term beyond such
date
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion of our consolidated financial condition and results of operations
should be read in conjunction with the financial statements and the related notes thereto included
in the Companys Form 10-KSB for the year ended December 31, 2007 and elsewhere in this Form 10-Q.
The matters discussed herein contain forward-looking statements within the meaning of Section 21E
of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933,
as amended, which involve risks and uncertainties. All statements other than statements of
historical information provided herein may be deemed to be forward-looking statements. Without
limiting the foregoing, the words believes, anticipates, plans, expects and similar
expressions are intended to identify forward-looking statements. The factors that could cause
actual future results to differ materially from current expectations include, but are not limited
to, risks related to regulatory approvals and the success of our ongoing studies, including the
efficacy of our Symphony tCGM System, the failure of future development and preliminary marketing
efforts related to our tCGM system, risks and uncertainties relating to our ability to develop,
market and sell diagnostic products based on our skin permeation platform technologies, including
the Prelude SkinPrep System, the availability of substantial additional equity or debt capital to
support our research, development and product commercialization activities, the success of our
research, development, and regulatory approval, marketing and distribution plans and strategies,
including those plans and strategies related to our tCGM System and those discussed in Risk
Factors in our Annual Report on Form 10-KSB for the fiscal year ended December 31, 2007 and
elsewhere in this report and the risks discussed in our other filings with the SEC. Readers are
cautioned not to place undue reliance on these forward-looking statements, which reflect
managements analysis, judgment, belief or expectation only as of the date hereof. We undertake no
obligation to publicly revise these forward-looking statements to reflect events or circumstances
that arise after the date hereof.
Overview
Echo Therapeutics, Inc. is a transdermal medical device and specialty pharmaceutical company
developing a non-invasive (needle-free), wireless, transdermal continuous glucose monitoring (tCGM)
system for people with diabetes and for use in hospital critical care units and a wide range of
topical reformulations of pharmaceutical products previously approved by the United States Food and
Drug Administration (FDA).
Echo Therapeutics, Inc. was formed through the merger of a wholly-owned subsidiary of Sontra
Medical Corporation and Durham Pharmaceuticals Ltd. (doing business
as Echo Therapeutics, Inc. (Durham)) in
September 2007. Previously, Durham was a majority-owned subsidiary of Cato
Holding Company (doing business as Cato BioVentures). Effective October 8, 2007, Sontra Medical
Corporation, a Minnesota corporation, changed its name to Echo Therapeutics, Inc. (Echo-MN).
15
On June 9, 2008, Echo-MN entered into an Agreement and Plan of Merger (the Merger Agreement)
with its wholly-owned subsidiary of the same name, Echo Therapeutics, Inc., a Delaware corporation
(Echo-DE), in order to change Echo-MNs state of incorporation from Minnesota to Delaware (the
Merger). The Merger Agreement and Merger were approved by Echo-MNs shareholders at Echo-MNs
Annual Meeting of the Shareholders on May 20, 2008. Pursuant to the Merger Agreement, Echo-MN
merged with and into Echo-DE and Echo-DE is the surviving corporation.
Our non-invasive Symphony tCGM System consists of our wireless transmission and transdermal
biosensor technologies and the Prelude SkinPrep System, which incorporates leading-edge,
needle-free skin permeation control. Our Symphony tCGM System is designed to provide both diabetics
and hospital patients with a reliable, affordable, comfortable-to-wear, and easy-to-use,
needle-free continuous glucose monitoring device. In July 2008, we completed a positive clinical
study of our Symphony tCGM System. Using 1,292 reference blood glucose measurements from the ten
subjects in the study, Clarke error grid analysis of the study data showed that Echos Symphony
tCGM System had approximately 99% of the data in the combined A/B zones, with 76.4% in the A zone
and 22.4% in the B zone, and only 0.2% and 0.9% in the C zone and D zone, respectively. The MARD
for the study was 13.8%. The correlation coefficient® for the data was 0.89. There were no adverse
events reported from Prelude skin permeation or the Symphony tCGM biosensor.
The accompanying consolidated financial statements have been prepared on a going concern
basis, which contemplates the realization of assets and the satisfaction of liabilities in the
normal course of business. As of June 30, 2008, we had cash of approximately $1,316,000 and an
accumulated deficit of approximately $54,000,000. Through June 30, 2008, we had no sales or
revenues to cover our costs and operating expenses. Although we have been able to issue securities
through senior promissory notes, secured promissory notes and a series of private placements to
raise capital in order to fund our operations, it is not known whether we will be able to continue
this practice, or be able to obtain other types of financing to meet our cash operating expenses.
This, in turn, raises substantial doubt about our ability to continue as a going concern.
Management is currently pursuing additional private equity financing, and such financing is
expected to be completed during 2008. However, no assurances can be given as to the success of
these plans. The consolidated financial statements do not include any adjustments that might result
from the outcome of these uncertainties.
Strategic Acquisition of Durham Pharmaceuticals Ltd.
On
September 14, 2007, we acquired Durham (the Durham Acquisition). Durham was a development-stage company
focused on a broad portfolio of advanced topical reformulations of FDA-approved pharmaceutical
products using its proprietary AzoneTS drug delivery technology. Durhams lead
AzoneTS-reformulated product, Durhalieve, is focused on the treatment of
corticosteroid responsive dermatoses and is covered by a New Drug Application on file with the FDA.
Durhalieve is also expected to be developed for the treatment of keloid scarring. We acquired
principally patented and unpatented pipeline specialty pharmaceutical product candidates, AzoneTS
formulation know-how and data-based technology related to AzoneTS Drug Master Files (including more
than 20 years of clinical and product development documentation) (DMFs). We purchased the DMFs
and related trademark and tradenames from an affiliate of Durham. We also entered into a Strategic
Master Services Agreement with Cato Research Ltd. (Cato Research), a global contract research and
development organization (CRO), providing for discounted service fees.
Since inception of Durham and up to the time of the Durham Acquisition, Durham operated as
both a majority-owned subsidiary of Cato Holding Company (doing business as Cato BioVentures, Cato
BioVentures) and a strategic drug development partner of Cato Research. We believe the research
and development of Durhams AzoneTS drug candidate formulations was conducted through projects
performed using contracted services through Cato BioVentures and Cato Research, as Durham had no
employees. During the period from its inception in 1999 through the date of the Durham Acquisition,
Durham incurred approximately $7,500,000 of costs and expenses related to its product development
and regulatory activities and had no product or service revenues.
As a result of the Durham Acquisition, we are now a transdermal medical device and specialty
pharmaceuticals company.
Results of Operations
We substantially reduced our staff and restructured our operations in December 2006.
Commencing in January 2007 and throughout 2007, we hired certain former employees and new employees
and engaged numerous independent contractors from time to time. As of June 30, 2008, we had eleven
(11) employees and five (5) independent contractor arrangements with consultants. Of this group of
employees and consultants, six (6) are involved with finance and administration and ten (10) are
involved with research and development, and clinical and regulatory matters. In addition to these
individuals, the Company utilized outside contract engineering and clinical research organizations
during the first half of 2008. As a result of our
16
restructuring in December 2006, the expenses for the six months ended June 30, 2008 may not be
comparable with those in the same period in 2007.
Comparison of the six months ended June 30, 2008 and 2007
Licensing Revenue Licensing revenue for the six months ended June 30, 2008 was zero
compared to $25,000 for the six months ended June 30, 2007, which were earned solely through an
agreement with HortResearch. In 2005 and 2006, HortResearch paid us $50,000 each year for a one
year option to license the use of our ultrasonic skin permeation technology. Accordingly, the
payments were recognized as revenue ratably over the service periods. In November 2007,
HortResearch did not elect to renew its license option.
Product Revenue and Cost of Product Revenue As a result of our strategic decision to not
pursue sales and marketing of the SonoPrep System, we had no product revenue in the six months
ended June 30, 2008. For the same period in 2007, we had nominal revenues of $12,120 with a cost
of product revenue of $1,556 related to our sales and marketing of SonoPrep.
Research and Development Expenses Research and development expenses increased by $941,813
to $1,541,906 for the six months ended June 30, 2008 from $600,093 for the six months ended June
30, 2007. Research and development expenses amounted to 39% of total operating expenses during the
six months ended June 30, 2008, and included product development expenses (including outside
contract engineering) for our next generation skin permeation technology, product development for
our next generation transdermal continuous glucose monitoring (tCGM) system, clinical study
expenses (including contract research organizations) associated with our tCGM system in a hospital
critical care and ambulatory settings, and research and regulatory expenses related to our
specialty pharmaceutical product candidate, Durhalieve. Product development and clinical expenses
included in research and development expenses represented approximately 94% and 6%, respectively,
of research and development expenses for the six months ended June 30, 2008. Product development
and clinical expenses included in research and development expenses represented approximately 86%
and 14%, respectively, of research and development expenses for the six months ended June 30, 2007.
Selling, General and Administrative Expenses Selling, general and administrative expenses
increased by $1,359,968 to $2,404,383 for the six months ended June 30, 2008 from $1,044,415 for
the six months ended June 30, 2007. This increase was due primarily to an increase in Company
personnel and related costs, additional public company costs related to investor relations, legal,
accounting, printing and media and expanded capital raising costs. Selling, general and
administrative expenses represented 61% and 64% of total operating expenses during the six months
ended June 30, 2008 and 2007, respectively, and included an increase in share-based compensation
expense of approximately $479,000 to $990,000. Share-based compensation expenses are a non-cash
charge relating to the fair value assigned to the issuance of restricted common stock, options and
warrants to purchase our common stock by employees, directors and certain service providers. We are
not engaged in selling activities and accordingly, general and administrative expenses relate to
salaries and benefits for our executive, financial and administrative staff, public company costs
related to investor relations, legal, accounting, printing and media costs, capital-raising costs
including those associated with travel, legal and accounting costs, and costs for general
operations.
Other Income (Expense) Interest income was $17,075 for the six months ended June 30, 2008,
compared to interest income of $13,906 for the six months ended June 30, 2007, an increase of
$3,169. The increase in interest income for the six months ended June 30, 2008 was primarily
attributable to our higher average amount of cash equivalents on hand during 2008 compared to 2007.
Interest expense was $558,390 for the six months ended June 30, 2008, compared to interest
expense of $6,157 for the six months ended June 30, 2007, an increase of $552,233. The increase in
interest expense is partly due to an increase in the amount of funding obtained through the use of
convertible and secured note arrangements. Bridge Notes in the amount of $1.325 million issued on
September 14, 2007 were either exchanged for Senior Convertible Notes or converted into shares of
our common stock in February 2008. Included in interest expense is approximately $502,000 of
non-cash interest related primarily to the amortization of discounts on notes payable, the
amortization of deferred financing costs and interest satisfied through the issuance of promissory
notes.
Interest expense of $6,157 for the six months ended June 30, 2007 related to an outstanding
note payable on equipment financing secured in 2005. The entire outstanding note payable on
equipment financing was paid in full in September 2007.
Derivative Loss Due to certain requirements to obtain and maintain an effective registration
statement covering the shares of common stock underlying the Imperium Warrants, we originally
determined that the Imperium Warrants did not meet the requirements for classification as equity as
described in EITF Issue No. 00-19, Accounting for Derivative Financial Instruments Indexed to, and
Potentially Settled in, a Companys Own Stock. As a result, the fair value of the Imperium
Warrants was recorded as a derivative liability which resulted in the recognition of a derivative
loss upon issuance in the amount of approximately $569,000 in March 2008. As of May 14, 2008, the
Company and Imperium executed Amendment
17
No. 1 to the Registration Rights Agreement and, as a result, the Imperium Warrants were no longer
required to be recorded as a derivative liability. The derivative liability was adjusted to fair
value at May 14, 2008 with the net increase in the fair value of approximately $17,000 being
recorded as an additional derivative loss.
Loss on Extinguishment of Debt We determined that the terms of the Senior Convertible
Notes are deemed substantially different, as described in EITF Issue No. 96-19, Debtors
Accounting for a Modification or Exchange of Debt Instruments, from the terms of the Bridge Notes
based on the change in the fair value of the embedded conversion features. As a result, we recorded
the Senior Convertible Notes issued in exchange for the Bridge Notes at fair value on the date of
issuance and recorded a loss on extinguishment of debt of approximately $586,000. The fair value of
the warrants issued to the holders of the Bridge Notes upon conversion into the Senior Convertible
Notes, which we estimated to be approximately $626,000, was also included in the loss on
extinguishment of debt. The difference between the fair value and the face value of the Senior
Convertible Notes is being accreted to interest expense over the term of the notes.
Net Loss As a result of the factors described above, we had a net loss of $6,286,334 for
the six months ended June 30, 2008 compared to $1,601,195 for the six months ended June 30, 2007.
Comparison of the three months ended June 30, 2008 and 2007
Licensing Revenue Licensing revenue for the three months ended June 30, 2008 was zero
compared to $12,500 for the three months ended June 30, 2007 through an agreement with
HortResearch. In 2005 and 2006, HortResearch paid us $50,000 each year for a one year option to
license the use of our ultrasonic skin permeation technology. Accordingly, the payments were
recognized as revenue ratably over the service periods. In November 2007, HortResearch did not
elect to renew its license option.
Product Revenue and Cost of Product Revenue As a result of our decision to not pursue sales
and marketing of the SonoPrep System, we had no product revenue in the three months ended June 30,
2008. For the same period in 2007, we had nominal revenues of $2,353 with no cost of product
revenue.
Research and Development Expenses Research and development expenses increased by $431,211
to $771,699 for the three months ended June 30, 2008 from $340,488 for the three months ended June
30, 2007. Research and development expenses amounted to 39% and 33% of total operating expenses
during the three months ended June 30, 2008 and 2007, respectively, and included product
development expenses (including outside contract engineering) for our next generation skin
permeation technology, product development for our next generation transdermal continuous glucose
monitoring (tCGM) system, clinical study expenses (including contract research organizations)
associated with our tCGM system in a hospital critical care and ambulatory settings and, research
and regulatory expenses related to our specialty pharmaceutical product candidate, Durhalieve.
Product development and clinical expenses included in research and development expenses for the
three months ended June 30, 2008 represented approximately 95% and 5%, respectively, of research
and development expenses. Product development and clinical expenses included in research and
development expenses for the three months ended June 30, 2007 represented approximately 87% and
13%, respectively, of research and development expenses.
Selling, General and Administrative Expenses Selling, general and administrative expenses
increased by $521,491 to $1,213,966 for the three months ended June 30, 2008 from $692,475 for the
three months ended June 30, 2007. This increase was due primarily to an increase in Company
personnel and related costs, additional public company costs related to investor relations, legal,
accounting, printing and media and expanded capital raising costs. Selling, general and
administrative expenses represented 61% and 67% of total operating expenses during the three months
ended June 30, 2008 and 2007, respectively, and included an increase in share-based compensation
expense of approximately $81,000 to $504,000. Share-based compensation expenses are a non-cash
charge relating to the fair value assigned to the issuance of restricted common stock, options and
warrants to purchase our common stock by employees, directors and certain service providers. We are
not engaged in selling activities and accordingly, general and administrative expenses relate to
salaries and benefits for our executive, financial and administrative staff, public company costs
related to investor relations, legal, accounting, printing and media costs, capital-raising costs
including those associated with travel, legal and accounting costs, and costs for general
operations.
Other Income (Expense) Interest income was $6,607 for the three months ended June 30, 2008,
compared to interest income of $7,580 for the three months ended June 30, 2007, a decrease of $973.
The decrease in interest income for the three months ended June 30, 2008 was primarily attributable
to our lower average amount of cash equivalents that we had on hand during 2008 compared to 2007.
Interest expense was $278,157 for the three months ended June 30, 2008, compared to interest
expense of $3,699 for the three months ended June 30, 2007, an increase of $274,458. The increase
in interest expense is partly due to an increase in the amount of funding obtained through the
use of convertible and secured note arrangements. Bridge Notes in the amount
18
of $1.325 million issued on September 14, 2007 were either exchanged for Senior Convertible Notes
or converted into shares of our common stock in February 2008. Included in interest expense is
approximately $231,000 of non-cash interest related primarily to the amortization of discounts on
notes payable and the amortization of deferred financing costs.
Interest expense of $3,699 for the three months ended June 30, 2007 related to an outstanding
note payable on equipment financing secured in 2005. The entire outstanding note payable on
equipment financing was paid in full in September 2007.
Derivative Loss Due to certain requirements to obtain and maintain an effective registration
statement covering the shares of common stock underlying the Imperium Warrants, we determined that
the Imperium Warrants did not meet the requirements for classification as equity as described in
EITF Issue No. 00-19, Accounting for Derivative Financial Instruments Indexed to, and Potentially
Settled in, a Companys Own Stock. As a result, the fair value of the Imperium Warrants was
recorded as a derivative liability which resulted in the recognition of a derivative loss upon
issuance in the amount of approximately $569,000 in March 2008. As of May 14, 2008, the Company and
Imperium executed Amendment No. 1 to the Registration Rights Agreement and, as a result, the
Imperium Warrants were no longer required to be recorded as a derivative liability. The derivative
liability was adjusted to fair value at May 14, 2008 with the net increase in the fair value of
approximately $48,000 being recorded as an additional derivative loss for the three months ended
June 30, 2008.
Net Loss As a result of the factors described above, we had a net loss of $2,305,233 for
the three months ended June 30, 2008 compared to $1,014,229 for the three months ended June 30,
2007.
Liquidity and Capital Resources
We have financed our operations since inception primarily through private sales of common and
preferred stock, the issuance of convertible promissory notes and secured promissory notes, and
cash received in connection with exercises of options and warrants. As of June 30, 2008, we had
$1,315,901 of cash and cash equivalents, with no other short term investments.
Net cash used in operating activities was approximately $2,234,000 for the six months ended
June 30, 2008. The use of cash in operating activities was primarily attributable to the net loss
of approximately $6,286,000 for the six months ended June 30, 2008, offset by non-cash expenses of:
approximately $102,000 for depreciation and amortization, approximately $990,000 for share-based
compensation, the fair value of common stock and warrants issued for services of approximately
$354,000, a derivative loss of approximately $587,000, a debt extinguishment loss of approximately
$1,212,000 and approximately $502,000 of interest expense relating to the amortization of
discounts and deferred financing costs. Increases in accounts payable and accrued expenses
provided approximately $343,000 of cash and an increase in prepaid expenses used cash of
approximately $38,000.
Net cash used in investing activities was approximately $25,000 for the six months ended June
30, 2008 and related to the cash used to purchase property and equipment.
Net cash provided by financing activities was approximately $2,382,000 for the six months
ended June 30, 2008 and was comprised of gross proceeds from the issuances of Senior Convertible
Notes and Secured Notes in the aggregate amount of approximately $2,700,000 and proceeds from the
exercise of common stock purchase warrants in the amount of approximately $114,000, less cash paid
for deferred financing costs of approximately $432,000.
At June 30, 2008, we had outstanding warrants to purchase 4,612,201 shares of common stock at
exercise prices ranging from $0.21 to $50.00 per share.
As of August 5, 2008, we had cash and cash equivalents of approximately $830,000.
Senior Convertible Notes On February 11, 2008, we completed an approximately $2.3 million
private financing with substantially all of the former holders of our Bridge Notes issued in
September 2007. The $2,292,459 in aggregate principal amount of unsecured Senior Convertible Notes
issued in the financing (the Senior Convertible Notes) bear interest annually at a rate of 8.0%
per annum and provide the holders with the right to convert principal into shares of our common
stock at $1.35 per share. The conversion price is subject to weighted average anti-dilution
protection, excluding certain customary exceptions. The Senior Convertible Notes have a three-year
term and we may elect to make payments of interest in cash, additional notes, or stock.
Additionally, the investors received warrants to purchase 849,058 shares of common stock at an
exercise price of $1.69 per share for a term of five years. The warrants provide for full
anti-dilution price protection to the holders and allow for cashless exercise.
19
In connection with the Senior Convertible Note financing, certain holders representing
$1,275,000 face value of Bridge Notes exchanged their Bridge Notes at 120% of the outstanding
principal and interest of the Bridge Notes as payment toward the purchase price of the Senior
Convertible Notes purchased by such holders. Accordingly, we issued notes in the Senior Convertible
Note financing in the aggregate principal balance of $1,592,459 to the former holders of the Bridge
Notes upon their surrender of the Bridge Notes, and we received gross cash proceeds in the amount
of $700,000 in connection with the financing.
One holder of a Bridge Note with a face value of $50,000 converted the principal and accrued
interest of such Bridge Note into 52,041 shares of our common stock, using a $1.00 conversion price
as provided in the terms of the Bridge Notes. This was the last Bridge Note outstanding, and as
such, following its conversion, no Bridge Notes remain outstanding.
We are using the net proceeds from the Senior Convertible Note offering for product
development, working capital and general corporate purposes.
We paid Burnham Hill Partners, a division of Pali Capital, Inc., $162,000 in connection with
the Senior Convertible Note financing and provided its designees/assignees warrants to purchase an
aggregate of 175,013 shares of common stock at an exercise price of $1.49 per share.
2008 Secured Note and Warrant Financing On March 24, 2008, we entered into a Secured Note
financing with Imperium providing for, at our option, the issuance of up to an aggregate $2,000,000
of original issue discount senior secured notes (the Secured Notes) in four equal tranches,
together with warrants (the Imperium Warrants) to purchase up to 634,920 shares of our common
stock at an exercise price of $2.00 per share. On March 24, 2008, we drew down the initial $500,000
in gross proceeds and issued the Imperium Warrants upon execution of the agreement. We also issued
three additional Secured Notes and drew down $500,000 in gross proceeds on each of April 24, 2008,
June 2, 2008 and June 24, 2008, thus completing the $2,000,000 financing.
We are not required to make monthly payments of principal and interest under our Secured
Notes. Instead, the outstanding principal of each Secured Note will accrete in value at an annual
rate of 10%, compounded monthly, resulting in a total principal amount of approximately $552,357
due for each Secured Note at maturity. If we complete an equity issuance in one or more series of
transactions totaling $5,000,000 (a Qualified Issuance), then the aggregate amount due for each
Secured Note will be reduced from $552,357 to $546,903 and the annual accretion value will be
reduced from 10% to 9%.
Each Secured Note is due twelve months after the date of the issuance, provided, however, that
if we complete a Qualified Issuance by October 31, 2008, we may extend the maturity date of each
Secured Note to 24 months after the date of the issuance. We may repay the principal amount of the
Secured Notes in cash, in whole, but not in part, prior to maturity at a premium of 1.02 times the
unpaid principal plus any other amount due under the Secured Notes.
All amounts outstanding under the Secured Notes, plus penalties, become due and payable upon
the occurrence of an event of default or upon a change in control, as defined in the Secured Notes.
In addition, we have agreed to certain covenants, including a prohibition on our ability to incur
future indebtedness (subject to certain exceptions) or make any dividend or payment to holders of
our capital stock (other than shares of the class of stock held by such recipient), and a
requirement that we maintain $6.5 million in stockholders equity (excluding any impact of the
issuance of the Imperium Warrants to stockholders equity) for so long as the Secured Notes remain
outstanding. Because costs associated with the development of our products will increase our
liabilities, the requirement that we maintain a certain level of stockholders equity could limit
our ability to pursue necessary product development if we fail to raise additional equity capital.
We also agreed that we may not redeem our Senior Convertible Notes as long as the Secured
Notes remain outstanding, unless we receive at least $10 million in gross proceeds from an issuance
or series of related issuances of equity securities.
Our subsidiary, Sontra Medical, Inc., has guaranteed our obligations under the Secured Notes.
Additionally, the Secured Notes are secured by all of our assets.
The Imperium Warrants have a term of five years and are immediately exercisable at an exercise
price of $2.00 per share. The Imperium Warrants provide for weighted average anti-dilution
protection upon future issuances or deemed issuances (subject to customary exceptions) below the
exercise price. The Imperium Warrants also allow for cashless exercise unless the shares underlying
the Warrants are registered for resale on a registration statement filed under the Securities Act
of 1933, as amended (the Securities Act). An exercise under the Imperium Warrants may not result
in the holder beneficially owning more than 9.9% of our common stock outstanding at the time. The
holder may waive the foregoing upon 60 days advance written notice.
20
In connection with the issuance of the Secured Notes and Imperium Warrants, on March 24, 2008,
we entered into a Registration Rights Agreement (the Registration Rights Agreement) pursuant to
which we agreed to file a registration statement with the Securities and Exchange Commission
covering the resale of the common stock issuable upon exercise of the Imperium Warrants within 60
days after issuance of the securities. On May 14, 2008, the Company and Imperium executed Amendment
No.1 to the Registration Rights Agreement that removed the registration requirements for the
underlying securities in connection with the financing, but granted the holders of the Imperium
Warrants piggy-back registration rights with respect to certain registration statement filings by
the Company in the future.
Our Secured Note financing agreement with Imperium includes a number of restrictive covenants,
including a prohibition on our ability to incur future indebtedness (subject to certain exceptions)
or make any dividend or payment to holders of our capital stock (other than shares of the class of
stock held by such recipient), and a requirement that we maintain $6.5 million in stockholders
equity (excluding any impact of the issuance of the Imperium Warrants to stockholders equity) for
so long as the Secured Notes remain outstanding. In order to advance our product development,
clinical programs and financing activities, we expect our monthly salaries and benefits, consulting
costs, legal costs and other working capital costs to increase. Because costs associated with the
development of our products will increase our liabilities, the requirement that we maintain a
certain level of stockholders equity could limit our ability to pursue necessary product
development if we fail to raise additional equity capital. Therefore, in order to achieve our
business objectives while continuing to satisfy the restrictive covenants of the Secured Notes, we
will be required to raise additional capital in 2008.
Our ability to incur additional indebtedness is significantly restricted by the terms of our
Secured Notes and other outstanding debt securities. Accordingly, we must raise substantial equity
capital in 2008 in order to continue our operations as planned.
We believe we have the ability to manage our costs aggressively and increase our operating
efficiencies while continuing our current level of product development and clinical programs
thereby maximizing the time available to complete an equity financing. Delays in obtaining an
equity financing could cause us to delay or halt our product development and clinical programs.
Although we believe that the required financing can be completed, there can be no guarantee that
additional equity capital will be available on terms favorable to us, if at all.
Even if we are successful in raising additional equity capital during 2008, we will still be
required to raise substantial additional capital in the future to fund our research and development
programs, commercialize our product candidates and achieve profitability. Our ability to fund our
future operating requirements will depend on many factors, including:
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our ability to obtain funding from third parties, including any future collaborative
partners, on reasonable terms; |
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our progress on research and development programs; |
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the time and costs required to gain regulatory approvals; |
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the costs of manufacturing, marketing and distributing our products, if successfully
developed and approved; |
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the costs of filing, prosecuting and enforcing patents, patent applications, patent
claims and trademarks; |
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the status of competing products; and |
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the market acceptance and third-party reimbursement of our products, if successfully
developed and approved. |
Strategic Product Development Agreement with Cato Research In connection with the Durham
Acquisition, we entered into a Strategic Master Services Agreement with Cato Research (Cato Master
Agreement) to provide us with contract research and development services and regulatory advice
(CRO Services). The Cato Master Agreement has an initial one year term, and is automatically
renewable for additional one-year terms unless either party provides sixty days notice prior to
the expiration of any one year term. The Cato Master Agreement provides an initial $80,000 credit,
of which $80,000 was used through June 30, 2008, for CRO Services and an ongoing 25% discount on
all CRO Services rendered on a time and materials basis during the term of the agreement. In
connection with the Cato Master Agreement, we entered into a Strategic Deferred Payment Agreement
with Cato Research in September 2007 (the Cato SDPA). Pursuant to the Cato SDPA, we are entitled
to defer payment to Cato Research for certain critical path CRO Services provided under the Cato
Master Agreement for the earlier of six (6) months from the due date of each invoice relating to
such CRO Services or the date we receive at least $5,000,000 in equity financing following the date
of the agreement. As of June 30, 2008, we have not
21
deferred any payments for CRO Services. The CRO Services covered by the Cato Master Agreement
relate to core AzoneTS drug development programs, regulatory matters related to such development
programs and other programs as agreed upon by the parties. The Cato SDPA may be extended for three
(3) months by agreement of the parties.
Dermatology Product Candidate Agreement with Cato BioVentures On April 21, 2008, we
entered into a Dermatology Product Candidate Right of First Offer Agreement (the Right of First
Offer Agreement) with Cato BioVentures pursuant to which Cato BioVentures granted to us a right of
first offer to purchase certain dermatology small molecule drug or protein biologic product
candidates or transdermal drug delivery technologies which Cato BioVentures owns or licenses, as
well as those owned by a third party for which Cato BioVentures has a right to disclose to us
(Available Product Candidates). Under the terms of the Right of First Offer Agreement, Cato
BioVentures must promptly notify us of an Available Product Candidate and discuss such Available
Product Candidate exclusively with us for a period of at least 90 days. We must provide notice of
our interest in pursuing the Available Product Candidate within such 90 day period or we will be
deemed to have declined our rights to the Available Product Candidate. The Right of First Offer
Agreement terminates on December 31, 2010 unless the parties mutually agree to extend its term.
Item 4T. Controls and Procedures.
Disclosure Controls and Procedures. Our management, with the participation of our Chief
Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure
controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act) as of the end of the
period covered by this report. Based on that evaluation, our Chief Executive Officer and our Chief
Financial Officer concluded that our disclosure controls and procedures as of the end of the period
covered by this report were effective in ensuring that information required to be disclosed by us
in reports that we file or submit under the Exchange Act is recorded, processed, summarized and
reported within the time periods specified in the SECs rules and forms and that the information
required to be disclosed by us in such reports is accumulated and communicated to our management,
including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely
decisions regarding required disclosure.
Internal Control over Financial Reporting. There was no change in our internal control over
financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) that occurred during the
fiscal quarter to which this report relates that has materially affected, or is reasonably likely
to materially affect, our internal control over financial reporting.
PART IIOTHER INFORMATION
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
We issued 50,000 shares of common stock to an investor relations firm on each of June 20, 2008
and June 23, 2008 pursuant to a services agreement dated May 23, 2008, in consideration for
investor relations services. The issuance of the shares was made in a transaction not involving
any public offering pursuant to an exemption from registration under Section 4(2) of the Securities
Act.
On April 1, 2008, in accordance with the Senior Convertible Note Agreement dated February 11,
2008, we satisfied the interest payment for the period ended March 31, 2008 to one Note Holder
through the issuance of an additional convertible promissory note in the amount of approximately
$17,000. The issuance of the note was made in a transaction not involving any public offering
pursuant to an exemption from registration under Section 4(2) of the Securities Act.
Item 4. Submission of Matters to a Vote of Security Holders.
At our 2008 Annual Meeting of Shareholders (the Annual Meeting) on May 20, 2008, the
following matters were acted upon by our shareholders:
1. The election of five directors to the Companys Board of Directors;
2. The approval of the Companys reincorporation in the State of Delaware and other related
changes in the
rights of shareholders;
3. The approval of the Echo Therapeutics, Inc. 2008 Equity Incentive Plan; and
4. The ratification of the appointment of Wolf & Company, P.C. as the Companys independent
registered public
accounting firm for the fiscal year ending December 31, 2008.
22
The number of shares of common stock issued, outstanding and eligible to vote as of the record
date of March 31, 2008 was 18,510,581. The results of the voting on each of the matters presented
to shareholders at the Annual Meeting are set forth below:
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VOTES |
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VOTES |
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VOTES |
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BROKER |
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FOR |
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WITHHELD |
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AGAINST |
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ABSTENTIONS |
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NON-VOTES |
Election of directors |
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Vincent D. Enright |
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13,056,813 |
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0 |
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0 |
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0 |
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0 |
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Robert S. Langer, Sc.D. |
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13,072,053 |
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0 |
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0 |
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0 |
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0 |
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Patrick T. Mooney, M.D. |
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13,072,053 |
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0 |
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0 |
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0 |
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0 |
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Shawn K. Singh, J.D. |
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13,056,863 |
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0 |
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0 |
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0 |
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0 |
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Walter W. Witoshkin |
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13,071,843 |
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0 |
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0 |
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0 |
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0 |
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Reincorporation in Delaware |
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11,393,143 |
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0 |
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9,055 |
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237,930 |
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0 |
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2008 Equity Incentive Plan |
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11,220,865 |
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0 |
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166,978 |
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252,285 |
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0 |
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Ratify Wolf & Company |
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13,063,989 |
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0 |
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24,142 |
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242,876 |
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0 |
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Item 6. Exhibits.
The Exhibits listed in the Exhibit Index immediately preceding such Exhibits are filed with or
incorporated by reference in this report.
23
SIGNATURES
In accordance with the requirements of the Securities Exchange Act of 1934, the Registrant
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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ECHO THERAPEUTICS, INC.
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Date: August 14, 2008 |
By: |
/s/ Patrick T. Mooney, M.D.
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Patrick T. Mooney, M.D. |
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Chief Executive Officer and Chairman of the Board |
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By: |
/s/ Harry G. Mitchell, CPA
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Harry G. Mitchell, CPA |
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Chief Operating Officer, Chief Financial Officer
and Treasurer |
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24
EXHIBIT INDEX
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Exhibit No. |
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Item. |
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2.1
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Agreement and Plan of Merger, dated June 9, 2008, between Echo Therapeutics, Inc., a Minnesota
corporation, and Echo Therapeutics, Inc., a Delaware corporation, is incorporated herein by reference
to Exhibit 2.1 of the Companys Current Report on Form 8-K dated June 9, 2008. |
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2.2
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Certificate of Ownership and Merger merging Echo Therapeutics, Inc., a Minnesota corporation, with and
into Echo Therapeutics, Inc., a Delaware corporation, is incorporated herein by reference to Exhibit
2.2 of the Companys Current Report on Form 8-K dated June 9, 2008. |
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2.3
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Articles of Merger merging Echo Therapeutics, Inc., a Minnesota corporation, with and into Echo
Therapeutics, Inc., a Delaware corporation, is incorporated herein by reference to Exhibit 2.3 of the
Companys Current Report on Form 8-K dated June 9, 2008. |
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3.1
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Certificate of Incorporation of the Company is incorporated herein by reference to Exhibit 3.1 of the
Companys Current Report on Form 8-K dated June 9, 2008. |
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3.2
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Bylaws of the Company is incorporated herein
by reference to Exhibit 3.2 of the Companys Current
Report on Form 8-K dated June 9, 2008. |
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10.1
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Dermatology Product Candidate Right of First Offer Agreement is incorporated herein by reference to
Exhibit 10.1 of the Companys Current Report on Form 8-K dated April 25, 2008. |
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10.2
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Amendment No. 1 to Registration
Rights Agreement between the Company and Imperium Master Fund, Ltd. is
incorporated herein by reference to Exhibit 10.1 to the Companys
Current Report on Form 8-K dated May
15, 2008. |
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31.1
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Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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31.2
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Certification of the Chief Operating Officer and Chief Financial Officer pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002. |
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32.1
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Certification of the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002. |
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32.2
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Certification of the Chief Operating Officer and Chief Financial Officer pursuant to 18 U.S.C. Section
1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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