10-Q
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 October 31, 2009
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the transition period from
to
Commission file number 0-17263
CHAMPIONS
BIOTECHNOLOGY, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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52-1401755 |
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(State or other jurisdiction of incorporation
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(I.R.S. Employer Identification No.) |
or organization)
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855 N. Wolfe Street, Suite 619, Baltimore, MD
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21205 |
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(Address of principal executive
offices)
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(Zip code) |
(410) 369-0365
(Registrants telephone number, including area code)
(Former name, former address and former fiscal year, if changed from
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 has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant
to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such
shorter period that the registrant was required to submit and post such files). Yes o No o
Indicate by check mark whether the registrant is a large accelerated file, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See definitions of large accelerated
filer, accelerated filer, and smaller reporting company in Rule 12b-2 of the Exchange Act
(check one):
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company þ |
Indicate by check mark whether the registration is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
As of December 14, 2009, the Registrant had a total of 32,865,185 shares of common stock outstanding.
CHAMPIONS BIOTECHNOLOGY, INC.
FORM 10-Q
INDEX
2
PART I. FINANCIAL INFORMATION
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Item 1. |
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Financial Statements. |
CHAMPIONS BIOTECHNOLOGY, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
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October 31,
2009 |
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April 30,
2009 |
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(unaudited) |
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ASSETS |
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CURRENT ASSETS |
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Cash and cash equivalents |
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$ |
394,000 |
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$ |
1,728,000 |
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Short term investments |
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1,017,000 |
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Accounts receivable |
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72,000 |
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Prepaid expenses, deposits, and other receivables |
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692,000 |
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1,125,000 |
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Total current assets |
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1,158,000 |
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3,870,000 |
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Property and equipment, net |
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97,000 |
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81,000 |
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Goodwill |
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669,000 |
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669,000 |
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TOTAL ASSETS |
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$ |
1,924,000 |
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$ |
4,620,000 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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CURRENT LIABILITIES |
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Accounts payable |
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$ |
1,185,000 |
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$ |
1,414,000 |
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Accrued liabilities |
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106,000 |
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67,000 |
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Deferred revenue |
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131,000 |
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1,223,000 |
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Total current liabilities |
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1,422,000 |
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2,704,000 |
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COMMITMENTS AND CONTINGENCIES |
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Accrued stock repurchase |
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219,000 |
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STOCKHOLDERS EQUITY |
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Preferred stock, $10 par value; 56,075 shares
authorized; 0 shares issued and outstanding |
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Common stock, $0.001 par value; 50,000,000 shares
authorized; 33,844,000 and 33,579,000 issued at October
31, 2009 and April 30, 2009, respectively,
and 32,865,000 and 32,989,000 shares outstanding at
October 31, 2009 and April 30, 2009, respectively |
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34,000 |
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34,000 |
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Treasury stock, at cost, 979,000 and 590,000 shares at
October 31, 2009 and April 30, 2009, respectively |
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(188,000 |
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(1,000 |
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Additional paid-in capital |
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11,783,000 |
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11,640,000 |
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Accumulated deficit |
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(11,344,000 |
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(9,757,000 |
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Accumulated other comprehensive income |
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(2,000 |
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Total stockholders equity |
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283,000 |
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1,916,000 |
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TOTAL LIABILITIES AND STOCKHOLDERS EQUITY |
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$ |
1,924,000 |
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$ |
4,620,000 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
CHAMPIONS BIOTECHNOLOGY, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
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Three Months Ended |
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Six Months Ended |
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October 31, |
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October 31, |
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2009 |
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2008 |
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2009 |
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2008 |
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OPERATING REVENUE |
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Personalized oncology services |
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$ |
589,000 |
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$ |
864,000 |
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$ |
1,488,000 |
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$ |
1,480,000 |
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Preclinical eValuation services |
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700,000 |
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180,000 |
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763,000 |
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237,000 |
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Total operating revenue |
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1,289,000 |
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1,044,000 |
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2,251,000 |
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1,717,000 |
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COSTS AND OPERATING EXPENSES |
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Cost of Personalized oncology services |
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(13,000 |
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369,000 |
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621,000 |
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595,000 |
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Cost of Preclinical eValuation services |
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350,000 |
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90,000 |
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384,000 |
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123,000 |
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Research and development |
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645,000 |
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417,000 |
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1,141,000 |
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649,000 |
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General and administrative |
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891,000 |
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354,000 |
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1,697,000 |
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688,000 |
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Total costs and operating expenses |
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1,873,000 |
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1,230,000 |
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3,843,000 |
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2,055,000 |
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LOSS BEFORE OTHER INCOME |
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(584,000 |
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(186,000 |
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(1,592,000 |
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(338,000 |
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Interest income |
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25,000 |
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5,000 |
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46,000 |
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LOSS BEFORE PROVISION FOR INCOME TAXES |
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(584,000 |
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(161,000 |
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(1,587,000 |
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(292,000 |
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Provision for income taxes |
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NET LOSS |
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$ |
(584,000 |
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$ |
(161,000 |
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$ |
(1,587,000 |
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$ |
(292,000 |
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NET LOSS PER SHARE BASIC AND DILUTED
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$ |
(0.02 |
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$ |
(0.00 |
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$ |
(0.05 |
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$ |
(0.01 |
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WEIGHTED AVERAGE SHARES OUTSTANDING
BASIC AND DILUTED |
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32,713,000 |
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33,273,000 |
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32,736,000 |
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33,271,000 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
4
CHAMPIONS BIOTECHNOLOGY, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
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Six Months Ended
October 31, |
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2009 |
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2008 |
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OPERATING ACTIVITIES |
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Net loss |
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$ |
(1,587,000 |
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$ |
(292,000 |
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Adjustments to reconcile net loss to net cash
used in operating activities: |
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Common stock issued for patent |
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175,000 |
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Stock-based compensation |
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184,000 |
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101,000 |
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Depreciation |
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16,000 |
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Changes in operating assets and liabilities: |
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Prepaid expenses, deposits, and other receivables |
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362,000 |
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(220,000 |
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Accounts payable |
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(229,000 |
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160,000 |
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Accrued liabilities |
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39,000 |
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(361,000 |
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Deferred revenue |
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(1,092,000 |
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(43,000 |
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Net cash used in operating activities |
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(2,132,000 |
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(655,000 |
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INVESTING ACTIVITIES |
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Proceeds from certificate of deposit |
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1,017,000 |
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Purchase of property and equipment |
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(32,000 |
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Purchase of intangibles |
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(9,000 |
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Net cash provided by (used in) investing activities |
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985,000 |
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(9,000 |
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FINANCING ACTIVITIES |
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Purchase of treasury stock |
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(188,000 |
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Proceeds from exercise of options and warrants |
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3,000 |
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7,000 |
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Net cash (used in) provided by financing activities |
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(185,000 |
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7,000 |
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Exchange rate effect on cash and cash equivalents |
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(2,000 |
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NET DECREASE IN CASH AND CASH EQUIVALENTS |
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(1,334,000 |
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(657,000 |
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CASH AND
CASH EQUIVALENTS
BEGINNING OF PERIOD |
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1,728,000 |
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3,709,000 |
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CASH AND CASH EQUIVALENTS END OF PERIOD |
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$ |
394,000 |
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$ |
3,052,000 |
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The accompanying notes are an integral part of these consolidated financial statements.
5
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 1. Organization, Use of Estimates and Basis of Presentation
Champions Biotechnology, Inc., (the Company, or we) is a biotechnology company that is
engaged in the development of advanced preclinical platforms and predictive tumor specific data to
enhance and accelerate the value of oncology drugs. In March 2009, the Company formed Champions
Biotechnology UK Limited, a wholly owned subsidiary, in order to establish operations in the United
Kingdom and Israel.
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States (GAAP) requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements and the reported amounts of revenue and
expenses during the reporting period. Actual results could differ from those estimates.
Significant estimates consist of share-based compensation and expenses related to personalized
oncology services.
During the three months ended October 31, 2009, the Company recognized a $218,000 reduction in
expense as a result of certain obligations being canceled by various vendors that were previously
accrued.
The accompanying condensed consolidated financial statements have been prepared assuming the
Company will continue as a going concern, which contemplates the realization of assets and the
satisfaction of liabilities in the normal course of business. The Company has experienced recurring
losses from operations while developing its service offerings and expanding its sales channels.
These operating losses are expected to continue into the near future as the Company continues to
expand. The Company will require additional capital beyond the cash currently on hand to fund these
expected near term operating losses. To meet these capital needs, the Companys management is
seeking to raise funds from various sources, including both the private placements and public
markets. There is no assurance that the Company will succeed in these fund-raising efforts. The
financial statements do not include any adjustments that might result from the outcome of this
uncertainty.
We evaluated subsequent events through the date the accompanying financial statements were
issued, which was December 15, 2009.
Note 2. Summary of Significant Accounting Policies
Unaudited Interim Financial Information
These unaudited condensed consolidated financial statements have been prepared pursuant to the
rules and regulations of the Securities and Exchange Commission (the SEC). All significant
intercompany transactions and accounts have been eliminated. Certain information related to the
Companys significant accounting policies and footnote disclosures normally included in financial
statements prepared in accordance with GAAP has been condensed or omitted. The accounting policies
followed in the preparation of these unaudited condensed consolidated are consistent with those
followed in the Companys annual consolidated financial statements for the year ended April 30,
2009, as filed on the Companys Annual Report on Form 10-K. In the opinion of management, these
unaudited condensed consolidated financial statements contain all material adjustments necessary to
fairly state our financial position, results of operations and cash flows for the periods presented
and the presentations and disclosures herein are adequate when read in conjunction with the
Companys Annual Report on Form 10-K for the year ended April 30, 2009.
Principles of Consolidation
The condensed consolidated financial statements include the accounts of the Company and its
wholly owned subsidiaries: Biomerk, Inc. and Champions Biotechnology UK, Limited. All material
intercompany transactions have been eliminated in consolidation.
6
The local currency of the Companys foreign operations is converted to U.S. currency for the
Companys condensed consolidated financial statements for each period being presented and the
Company is subject to foreign exchange rate fluctuations in connections with the Companys
international operations.
Segment Reporting
The Company operates as a single operation, using core infrastructure that serves the oncology
needs of customers through both personalized oncology and preclinical services. The Companys
chief operating decision maker assesses the Companys performance as a whole and no expense or
operating income is generated or evaluated on any component level.
Reclassifications
Certain reclassifications have been made to the prior period financial statement amounts to
conform to the current period presentation.
Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with an original maturity of
three months or less, to be cash equivalents. At various times throughout the year, the Company had
amounts on deposit at financial institutions in excess of federally insured limits. Our highly
liquid investments are maintained at well-capitalized financial institutions to mitigate the risk
of loss.
Fair Value of Financial Instruments
As of October 31, 2009, the carrying value of cash and cash equivalents, prepaid expenses,
deposits and other receivables, accounts payable, accrued liabilities and deferred revenue
approximate their fair value based on the liquidity or the short-term maturities of these
instruments.
Goodwill
Goodwill represents the excess of the cost over the fair market value of the net assets
acquired including identifiable assets. Goodwill is tested annually, or more frequently if
circumstances indicate potential impairment, by comparing its fair value to its carrying amount.
The determination of whether or not goodwill is impaired involves significant judgment. Although
the Company believes its goodwill is not impaired, changes in strategy or market conditions could
significantly impact the judgments and may require future adjustments to the carrying value of
goodwill.
Revenue Recognition
The Company derives revenue from Personalized Oncology and Preclinical eValuation services.
Personalized Oncology Services assist physicians by providing information that may enhance
personalized treatment options for their cancer patients through access to expert medical
information panels and tumor specific data. The Companys Preclinical eValuation services offer a
preclinical tumorgraft platform to pharmaceutical and biotechnology companies using Biomerk
Tumorgraft studies, which have been shown to be predictive of how drugs may perform in clinical
settings. The Company recognizes revenue when the following four basic criteria are met: 1) a
contract has been entered into with our customers; 2) delivery has occurred or services rendered to
our customers; 3) the fee is fixed and determinable as noted in the contract; and 4) collectability
is reasonably assured, as fees for services are remitted in full upon execution of the contract.
The Company utilizes a proportional performance revenue recognition model for its preclinical
eValuation services under which we recognize revenue as performance occurs, based on the relative
outputs of the performance that have occurred up to that point in time under the respective
agreement, typically the delivery of reports to our customers documenting the results of our
testing protocols.
7
When a Personalized Oncology or Preclinical eValuation arrangement involves multiple
elements, the items included in the arrangement (deliverables) are evaluated to determine whether
they represent separate units of accounting. We perform this evaluation at the inception of an
arrangement and as we deliver each item in the arrangement. Generally, we account for a deliverable
(or a group of deliverables) separately if: (1) the delivered
item(s) has standalone value to the customer, (2) there is objective and reliable evidence of
the fair value of the undelivered items included in the arrangement, (3) if we have given the
customer a general right of return relative to the delivered item(s), and (4) delivery or
performance of the undelivered item(s) or service(s) is probable and substantially in our control.
All revenue from contracts determined not to have separate units of accounting is recognized based
on consideration of the most substantive delivery factor of all the elements in the contract.
Research and Development
Research and development costs represent both costs incurred internally for research and
development activities as well as costs incurred externally to fund research activities. All
research and development costs are expensed as incurred. Non-refundable advance payments are
capitalized and recorded as expense when the respective product or services are delivered.
Recent Accounting Pronouncements
In August 2009, the Financial Accounting Standards Board (FASB) issued Accounting Standards
Update No. 2009-5, Measuring Liabilities at Fair Value (ASU 2009-05). ASU 2009-05 amends
Accounting Standards Codification Topic 820, Fair Value Measurements. Specifically, ASU 2009-5
provides clarification that in circumstances in which a quoted price in an active market for the
identical liability is not available, a reporting entity is required to measure fair value using
one or more of the following methods: (i) a valuation technique that uses the quoted price of the
identical liability when traded as an asset or quoted prices for similar liabilities or similar
liabilities when traded as assets and/or (ii) a valuation technique that is consistent with the
principles of Topic 820 of the Accounting Standards Codification (e.g. an income approach or market
approach). ASU 2009-05 also clarifies that (i) when estimating the fair value of a liability, a
reporting entity is not required to adjust to include inputs relating to the existence of transfer
restrictions on that liability and (ii) that both a quoted price in an active market for an
identical liability at the measurement date and a quoted price for the identical liability when
traded as an asset in an active market when no adjustments to the quoted price of the asset are
required are level one fair value measurements. ASU 2009-05 is effective for financial statements
issued for interim and annual periods beginning after August 28, 2009. We do not anticipate that
the adoption of this standard will have a material impact on our financial position and results of
operations.
In June 2009, the FASB issued guidance for determining whether an entity is a variable
interest entity (VIE). This guidance requires an enterprise to perform an analysis to determine
whether the enterprises variable interest or interests give it a controlling financial interest in
a VIE. Under this guidance, an enterprise has a controlling financial interest when it has (i) the
power to direct the activities of a VIE that most significantly impact the entitys economic
performance and (ii) the obligation to absorb losses of the entity or the right to receive benefits
from the entity that could potentially be significant to the VIE. Enterprises are also required to
assess whether they have an implicit financial responsibility to ensure that a VIE operates as
designed when determining whether it has power to direct the activities of the VIE that most
significantly impact the entitys economic performance. This guidance also requires ongoing
assessments of whether an enterprise is the primary beneficiary of a VIE, requires enhanced
disclosures and eliminates the scope exclusion for qualifying special-purpose entities. This
guidance is effective for annual reporting periods beginning after November 15, 2009. We do not
anticipate that the adoption of this guidance will have a material impact on our financial position
and results of operations.
In June 2009, the FASB approved the FASB Accounting Standards Codification (Codification)
as the single authoritative source for GAAP. The Codification, which was launched on July 1, 2009,
does not change current U.S. GAAP, but is intended to simplify user access by providing all
authoritative U.S. GAAP in one location. All existing accounting standards will be superseded and
all other accounting literature not included in the Codification will be considered
non-authoritative. The Codification is effective for interim and annual periods ending after
September 15, 2009. The Codification did not change GAAP and did not have a material impact on the
Companys condensed consolidated financial statements.
8
Note 3. Basic and Dilutive Loss Per Common Share
Basic loss per common share is computed by dividing our net loss by the weighted average
number of common shares outstanding during the period excluding the dilutive effects of options and
warrants. For the three and six months ended October 31, 2009 and 2008, diluted loss per common
share is computed on the same basis as basic loss per common share, as the inclusion of potential
common shares outstanding would be anti-dilutive. The
table below reflects the potential weighted average incremental shares of common stock that
have been excluded from the computation of diluted loss per common share since their effect would
be anti-dilutive.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
October 31, |
|
|
October 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
439,598 |
|
|
|
373,440 |
|
|
|
454,927 |
|
|
|
361,448 |
|
Warrants |
|
|
431,605 |
|
|
|
444,353 |
|
|
|
449,850 |
|
|
|
467,774 |
|
Restricted stock |
|
|
5,684 |
|
|
|
|
|
|
|
2,842 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total common stock
equivalents |
|
|
876,887 |
|
|
|
817,793 |
|
|
|
907,619 |
|
|
|
829,222 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 4. Property and Equipment
Property and equipment is recorded at cost and consists of laboratory equipment, furniture and
fixtures, computer hardware and software, and leasehold improvements. Depreciation is calculated
on a straight-line basis over the estimated useful lives of the various assets ranging from three
to seven years. Leasehold improvements are depreciated on a straight-line basis over the lesser of
the lease term or estimated useful life. Property and equipment consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
October 31, |
|
|
April 30, |
|
|
|
2009 |
|
|
2009 |
|
Laboratory equipment |
|
$ |
28,000 |
|
|
$ |
4,000 |
|
Furniture and fixtures |
|
|
32,000 |
|
|
|
26,000 |
|
Computer hardware and software |
|
|
55,000 |
|
|
|
55,000 |
|
Leasehold improvements |
|
|
2,000 |
|
|
|
|
|
|
|
|
|
|
|
|
Total property and equipment |
|
$ |
117,000 |
|
|
$ |
85,000 |
|
Less accumulated depreciation |
|
|
(20,000 |
) |
|
|
(4,000 |
) |
|
|
|
|
|
|
|
Property and equipment, net |
|
$ |
97,000 |
|
|
$ |
81,000 |
|
|
|
|
|
|
|
|
Depreciation expense was approximately $8,000 and $0 for the three months ended October 31,
2009 and 2008, respectively, $16,000 and $0 for the six months ended October 31, 2009 and 2008,
respectively.
Note 5. Licensing agreements
TAR-1 license agreement
In October 2009, the Company entered into a license agreement with an Israeli company for
world-wide rights to develop and commercialize a transactivation and apoptosis restoring (TAR-1)
developmental drug candidate. The Company may terminate the license agreement in whole or in part
on a country by country basis for any reason upon sixty days prior written notice.
Under the terms of the agreement, the Company will make an initial payment of $60,000 upon
execution of the agreement. In addition, the Company will be required to pay $6,140,000 upon
successful completion of certain clinical milestones, $5,000,000 upon reaching certain regulatory
approvals and $23,000,000 upon achievement of certain commercial milestones. The Company will also
make royalty payments based on net sales as defined in the license agreement. In addition, the
Company will pay an annual licensing fee of $30,000 for the first three years of the agreement
beginning on the second year of the agreement. The Company also agreed to pay for $118,000 of past
patent expenses incurred by the Israeli company prior to execution of the agreement. The initial
payment of past patent expenses, first annual licensing fee and initial payment were all charged to
research and development expense during the three months ended October 31, 2009.
Benzoylyphenylerea license agreement
In July 2009, the Company entered into a joint development and licensing agreement with a
third party for the development of a soluble form of SG 410, the Companys Benzoylyphenylerea (BPU)
sulfur analog compound. Under the joint agreement, the third party will be entitled to milestone
payments of $2,000,000 upon the
success of certain regulatory approvals and royalty payments on net sales of the licensed BPU
product. No amounts were due under this agreement as of October 31, 2009.
9
Note 6. Stock-Based Compensation
The Company may grant (i) Incentive Stock Options, (ii) Non-statutory Stock Options, (iii)
Restricted Stock Awards, and (iv) Stock Appreciation Rights (collectively, stock-based
compensation) to its employees, directors and non-employee consultants under a 2008 Equity
Incentive Plan that has not yet been approved by the Companys shareholders. Such awards may be
granted by the Companys Board of Directors. Options granted under the plan expire no later than
ten years from the date of grant and the awards vest as determined by the Board of Directors.
For share-based payments to non-employee consultants, the fair value of the share-based
consideration issued is used to measure the transaction, as management believes this to be a more
reliable measure of fair value than the services received. The fair value is measured at the value
of the Companys common stock or stock options on the date that the commitment for performance by
the non-employee consultant has been reached or the counterpartys performance is complete.
Stock-based compensation in the amount of $134,000 and $38,000 was recognized for the three
months ended October 31, 2009 and 2008, respectively and $184,000 and $100,000 for the six months
ended October 31, 2009 and 2008, respectively. Stock-based compensation costs were recorded as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
October 31, |
|
|
October 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Cost of personalized oncology services |
|
$ |
4,000 |
|
|
$ |
|
|
|
$ |
11,000 |
|
|
$ |
|
|
Research and development |
|
|
44,000 |
|
|
|
(2,000 |
) |
|
|
32,000 |
|
|
|
12,000 |
|
General and administrative |
|
|
86,000 |
|
|
|
40,000 |
|
|
|
141,000 |
|
|
|
88,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation expense |
|
$ |
134,000 |
|
|
$ |
38,000 |
|
|
$ |
184,000 |
|
|
$ |
100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Black-Scholes assumptions used to calculate the fair value of options and warrants granted
during the three months ended October 31, 2009 and 2008 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
Six Months Ended |
|
|
|
|
October 31, |
|
|
|
October 31, |
|
|
|
|
2009 |
|
|
|
2008 |
|
|
|
2009 |
|
|
|
2008 |
|
Expected term in years |
|
|
6.0 |
|
|
|
3.4 |
|
|
|
6.0 |
|
|
|
3.4 6.0 |
|
Risk free interest rates |
|
|
2.8% |
|
|
|
2.1% |
|
|
|
2.8% 3.1% |
|
|
|
2.1% 2.4% |
|
Volatility |
|
|
94% |
|
|
|
102% |
|
|
|
94% |
|
|
|
69% 102% |
|
Dividend yield |
|
|
0% |
|
|
|
0% |
|
|
|
0% |
|
|
|
0% |
|
Stock options and restricted stock
During the six months ended October 31, 2008, options to purchase 25,000 shares of the
Companys unregistered common stock were exercised resulting in the receipt by the Company of net
cash proceeds of $7,000. No options were exercised in the six months ended October 31, 2009.
During August 2009, the Company issued a total of 249,948 options to purchase the Companys
unregistered common stock to members of Board of Directors and employees. The options have an
exercise price of $0.77, expire in ten years, and vest evenly over three years from the date of
grant.
During the three months ended October 31, 2009, the Company granted 8,526 shares of restricted
common stock valued at $6,565 to our Chief Financial Officer. The shares vest evenly over three
years.
Warrants
During the six months ended October 31, 2009, warrants to purchase 15,408 shares of the
Companys unregistered common stock were exercised resulting in the receipt by the Company of net
cash proceeds of $3,000. No warrants were issued for the six months ended October 31, 2009.
Warrants to purchase 150,000 shares of the
Companys unregistered common stock were issued during the six months ended October 31, 2008.
No warrants were exercised during six months ended October 31, 2008.
10
At October 31, 2009, the Company has warrants outstanding to purchase 748,983 shares of the
Companys unregistered common stock with a weighted average exercise price of $0.36 per share which
expire from October 2011 through July 2014.
Stock Option Plans
In October 2009, the Company amended the director compensation plan wherein independent
directors of the Company shall be entitled to an annual award of options to purchase 50,000 shares
of the Companys unregistered common stock, and the Chairman of the Board of the Company shall be
entitled to an annual award of options to purchase 80,000 shares of the Companys unregistered
common stock.
Note 7. Related Party Transactions
Related party transactions include transactions between the Company and certain of its
shareholders, management and affiliates.
In May 2009, the Board of Directors approved a stock repurchase agreement with a Board member
which obligates the Company to purchase up to approximately $407,000 of the Companys common stock
held by the Board member over the next two years providing that the Board member continues his
services under a consulting agreement executed concurrently with the stock repurchase agreement.
Under the stock repurchase agreement, the Company made an initial purchase of $125,000 of Companys
shares of common stock, and may be required to make quarterly purchases of $31,250 of the Companys
common stock held by the Board member after the end of each fiscal quarter. Such purchases may
occur quarterly through April 2011 provided the consulting agreement remains in effect. The
purchase price per share of the common stock for each purchase is equal to the lesser price of
$0.50 or 50% of the average volume-weighted closing price of the stock as quoted on the OTC
Bulletin Board for the 30 day trading period ending on the day before the date of each purchase as
long as the consulting agreement remains in effect.
Under the agreement, the Company has paid this Board member approximately $188,000 for the
purchase of 389,062 shares of our common stock as of October 31, 2009.
The Company accounted for its obligation to repurchase shares of its common stock under the
stock repurchase agreement as a put option entered into in connection with a compensation
arrangement, and valued the obligation at fair value. The fair value of the put option was
determined to be de minimus, as the purchase price of the shares of common stock would be less than
the fair value of those shares unless the price of the Companys stock dropped significantly during
the 30 day trading period ending on the day before the date of each purchase which the Company
considered remote. Because the requirement for the Company to transfer cash in exchange for the
shares of common stock is not within its control, the Company initially recorded an amount equal to
the total purchase price required under the arrangement in temporary equity with a corresponding
reduction of additional paid-in capital. As of October 31, 2009, the Company has approximately
$219,000 remaining to be paid under the stock repurchase agreement based on the stock price as of
that date.
Further, under the stock repurchase agreement, the Company, at its option, may purchase all or
any part of the shares that have not been previously purchased, up to but not to exceed, 2,250,000
shares of the common stock at the discretion of the Company subject to the pricing formula
described above. This option may be exercised during the period of the consulting agreement or for
a period up to one year following the termination of the consulting agreement. The Company has
accounted for this as a purchased call option on its own stock. As this arrangement is indexed to,
and will be settle in, the Companys own shares of common stock, it has recorded a decrease to
stockholders equity at the call options fair value of $1,774,000. Additionally, because the
option provides the Company the ability to repurchase its own shares of common stock at a price
less than fair value and the call option was provided by a significant shareholder, the Company has
recorded a corresponding contribution to stockholders equity of $1,774,000.
11
Note 8. Stockholders Equity
In September 2009, the Company issued 250,000 shares of the Companys unregistered common
stock valued at $175,000 to the original owners of the SG 410 patent whereby the Company had
previously acquired the rights to the SG 410 patent in February, 2007. The unregistered common
stock was issued as the final contingent payment due upon issuance of the patent which occurred in
September 2009. The $175,000 expense is included in research and development expense in the
accompanying condensed consolidated statement of operations.
Note 9. Subsequent Events
Bithionol license agreement
In November 2009, the Company entered into a license agreement with two U.S. based companies.
The license agreement grants the Company world-wide rights to develop and commercialize Bithionol,
a drug candidate, for the treatment of various forms of cancer which include melanoma, prostate,
breast and lung cancer. The Company may terminate the license agreement in whole or in part on a
country by country basis for any reason upon sixty days prior written notice.
Under the terms of the agreement, the Company will make a payment of $50,000 upon execution of
the agreement. In addition, the Company will be required to pay $6,300,000 upon successful
completion of certain clinical milestones. The Company will also make royalty payments based on a
percentage of net sales as defined in the license agreement. In addition, the Company will pay
annual license fee payments ranging from $25,000 to $100,000 until the minimum royalty payments
outlined in the license agreement are met. The Company will also pay $29,780 for past patent
expenses incurred by the two U.S. based companies upon signing of the licensing agreement. All
amounts will be recorded as research and development expense.
Change in Management
Douglas D. Burkett, President and
Principal Executive Officer of the Company, advised the Company that he will resign his position
effective the close of business on December 31, 2009 but agreed to serve as a consultant to the
Company through June 7, 2010. On December 10, 2009, in conjunction with Dr. Burketts departure, the Company
amended Dr. Burketts employment agreement entitling Dr. Burkett to a bonus of $25,000 subject to the
completion of certain events before his departure subject to the satisfaction and discretion of the Audit
Committee and Compensation Committee of the Board of Directors. The amended employment agreement
also accelerated the vesting of 166,670 of Dr. Burketts unvested stock options to December 31, 2009. The Company has considered
this a Type III modification and will result in $43,000 of compensation expense to be recognized during the third quarter of fiscal 2009.
12
|
|
|
Item 2. |
|
Managements Discussion and Analysis of Financial Condition and Results of Operations. |
The following discussion of our historical results of operations and our liquidity and capital
resources should be read in conjunction with the financial statements and related notes that appear
elsewhere in this report.
Forward-Looking Statements
This Quarterly Report on Form 10-Q, including Item 2, Managements Discussion and Analysis of
Financial Condition and Results of Operations, contains certain forward-looking statements, which
include information relating to future events, future financial performance, strategies,
expectations, competitive environment, regulation, and availability of resources. These
forward-looking statements include, without limitation, statements regarding: proposed new
programs; expectations that regulatory developments or other matters will not have a material
adverse effect on our financial position, results of operations, or liquidity; statements
concerning projections, predictions, expectations, estimates, or forecasts as to our business,
financial and operational results, and future economic performance; and statements of managements
goals and objectives and other similar expressions concerning matters that are not historical
facts. Words such as may, should, could, would, predicts, potential, continue,
expects, anticipates, future, intends, plans, believes, estimates and similar
expressions, as well as statements in future tense, identify forward-looking statements.
Forward-looking statements should not be read as a guarantee of future performance or results,
and will not necessarily be accurate indications of the times at, or by, which such performance or
results will be achieved. Forward-looking statements are based on information available at the time
those statements are made or managements good faith belief as of that time with respect to future
events, and are subject to risks and uncertainties that could cause actual performance or results
to differ materially from those expressed in or suggested by the forward-looking statements.
Forward-looking statements speak only as of the date the statements are made. Factors that
could cause actual results to differ from those discussed in the forward-looking statements
include, but are not limited to, those described in Risk Factors in Part I, Item 1A of our Annual
Report on Form 10-K for the fiscal year ended April 30, 2009, as updated in our subsequent reports
filed with the SEC, including any updates found in Part II, Item 1A of this or other reports on
Form 10-Q. You should not put undue reliance on any forward-looking statements. We assume no
obligation to update forward-looking statements to reflect actual results, changes in assumptions,
or changes in other factors affecting forward-looking information, except to the extent required by
applicable securities laws. If we do update one or more forward-looking statements, no inference
should be drawn that we will make additional updates with respect to those or other forward-looking
statements.
Overview
The Company is engaged in the development of advanced preclinical platforms and predictive
tumor specific data to enhance and accelerate the value of oncology drugs. Our Preclinical
Platform is a novel approach based upon the implantation of primary human tumor fragments in immune
deficient mice followed by propagation of the resulting engraftments (Biomerk Tumorgrafts) in a
manner that preserves the biological characteristics of the original human tumor. We believe that
Biomerk Tumorgrafts closely reflect human cancer biology and their response to drugs is more
predictive of clinical outcomes in cancer patients. The Company is building its Biomerk Tumorgraft
platform through the procurement, development and characterization of numerous Tumorgrafts within
each of several cancer types. Tumorgrafts are procured through agreements with a number of
institutions in the U.S. and overseas and developed and tested through agreement with a U.S. based
preclinical facility.
We are leveraging our preclinical platform to evaluate oncology drug candidates and to develop
a portfolio of novel or repositioned drug candidates through pre-clinical or early clinical trials.
As drugs progress through this early stage of development, the Company plans to sell, partner or
license them to pharmaceutical and/or biotechnology companies, as appropriate. We believe this
strategy will enable us to leverage the competencies of these partners or licensees to maximize our
return on investment in a time frame that is shorter than for traditional drug development. We
believe that this model is unlike that of many new biotechnology companies that look to bring the
process of drug development through all phases of discovery, development, regulatory approvals, and
marketing, which requires a very large financial commitment and a long development period,
typically more than a decade, to commercialize. Thus far we have acquired or licensed three
oncology drug candidates, SG410, TAR-1, and Bithionol We have begun preclinical development of the
lead candidate, SG410, through the use of contract
facilities and have secured a preclinical supply of SG410 drug substance and developed a
soluble form of the compound and we intend to evaluate its efficacy in Biomerk Tumorgrafts from
several cancer types. If results are promising, it is our intention to continue preclinical
development and then sell, partner or license SG410 for its remaining clinical development. The
Company also entered into license agreements to develop and commercialize TAR-1 and Bithionol in
October, 2009 and November, 2009, respectively.
13
We also offer our Biomerk Tumorgraft predictive preclinical platform and tumor specific data
to physicians to provide information that may enhance personalized patient care options and to
companies for evaluation of oncology drugs in a platform that integrates predictive testing with
biomarker discovery. We provide Personalized Oncology services to physicians in the field of
oncology by establishing and administering expert medical information panels for their patients to
(i) arrange for testing, analysis and study of cancer tissues, as appropriate, (ii) analyze medical
records and test results, and (iii) assist in understanding conventional and research options. The
Company also develops and performs testing on Personalized Tumorgrafts to provide patients
physicians personalized data on treatment drug options.
Results of Operations
Three Months Ended October 31, 2009 and 2008
Revenues
Revenues for the three months ended October 31, 2009 and 2008 were $1,289,000 and $1,044,000,
respectively, an increase of $245,000 or 23%.
Revenues from Personalized Oncology Services (POS) for the three months ended October 31,
2009 and 2008 were $589,000 and $864,000, respectively, a decrease of $275,000 or 32%. This
decrease consisted of a $570,000 decrease in revenues from physician panels offset by a $295,000
increase in tumorgraft implantations, tumorgraft studies, and vaccine studies. Payments for POS
are generally received in advance and recorded as deferred revenue.
Revenues from Preclinical eValuation services for the three months ended October 31, 2009 and
2008 were $700,000 and $180,000, respectively, an increase of $520,000 or 288%. The Company
utilizes a proportional performance revenue recognition model for its preclinical eValuation
services under which we recognize revenue as performance occurs, based on the relative outputs of
the performance that have occurred up to that point in time under the respective agreement,
typically the delivery of reports to our customers documenting the results of our testing
protocols. Payments, or partial payments, for Preclinical eValuation services are generally
received in advance and recorded as deferred revenue.
Operating Expenses
Cost of Personalized Oncology Services (CPOS) for the three months ended October 31, 2009
and 2008 were ($13,000) and $369,000, respectively, a decrease of $382,000 or 104%. This decrease
is due to a $257,000 decrease in CPOS reflecting the 32% decrease in POS revenues and a one-time
$125,000 credit for accrued costs of a personalized oncology study agreement. We entered into a
personalized oncology study agreement in January 2009 with our contract research organizations
(CRO). In October 2009, we terminated the personalized oncology study due to certain
performance conditions on the Companys behalf. Subsequently, the obligation for the amount
payable was cancelled by the CROs resulting in a change in estimate and a one-time credit of
$125,000 to CPOS.
Cost of Preclinical eValuation services for the three months ended October 31, 2009 and 2008,
were $350,000 and $90,000, respectively, an increase of $260,000 or 289%. Cost of Preclinical
eValuation services increased due to the increase in Preclinical eValuation revenues.
Research
and development (R&D) expenses for the three months ended October 31, 2009 and 2008,
were $645,000 and $417,000, respectively, an increase of $228,000 or 55%. This increase is
primarily due to the $175,000 charge for the final payment made with our unregistered common stock
for the acquisition of the SG-410 patent, the recognition of licensing fees, and costs in
connection with our TAR-1 licensing agreement of $208,000 and, offset
by a $65,000 decrease in
tumorgraft acquisition and testing costs and the cancelation of an amount payable of $90,000 to
certain vendors for lack of performance.
14
General and administrative expenses for the three months ended October 31, 2009 and 2008, were
$891,000 and $354,000, respectively, an increase of $537,000 or 152%. This increase is primarily
due to our development of corporate infrastructure to support our increased generating activities
of the Company and includes increased payroll, legal, accounting, marketing, and office rent
expenses.
Interest Income
Interest income for the three months ended October 31, 2009 and 2008, was $0 and $25,000,
respectively. The decrease in interest income resulted from the Companys decrease in assets held
in interest bearing investments.
Net Loss
The Companys net loss for the three months ended October 31, 2009 and 2008, was $584,000 and
$161,000, respectively. The $423,000 increase in our net loss for the three months ended October
31, 2009, reflects the $643,000 increase in operating expenses and a net decline of $25,000 in
interest income offset by the $245,000 increase in revenues.
Six Months Ended October 31, 2009 and 2008
Revenues
Revenues for the six months ended October 31, 2009 and 2008, were $2,251,000 and $1,717,000,
respectively, an increase of $534,000 or 31%.
Revenues from POS for the six months ended October 31, 2009 and 2008, were $1,488,000 and
$1,480,000, respectively, an increase of $8,000 or 1%. This increase of $8,000 consisted of a
$735,000 decrease in revenues from physician panels offset by a $743,000 increase in tumorgraft
implantations, tumorgraft studies, and vaccine contracts. Payments for POS are generally received
in advance and recorded as deferred revenue.
Revenues from Preclinical eValuation services for the six months ended October 31, 2009 and
2008, were $763,000 and $237,000, respectively, an increase of $526,000 or 222%. The Company
utilizes a proportional performance revenue recognition model for its preclinical eValuation
services under which we recognize revenue as performance occurs, based on the relative outputs of
the performance that have occurred up to that point in time under the respective agreement,
typically the delivery of reports to our customers documenting the results of our testing
protocols. Payments, or partial payments, for Preclinical eValuation services are generally
received in advance and recorded as deferred revenue.
Operating Expenses
CPOS for the six months ended October 31, 2009 and 2008, were $621,000 and $595,000,
respectively, an increase of $26,000 or 4%. This increase is due to a $151,000 increase in CPOS
offset by a one-time $125,000 credit for accrued costs of a personalized oncology study agreement.
We entered into a personalized oncology study agreement in January 2009 with our contract research
organizations (CRO). In October 2009, we terminated the personalized oncology study due to
certain performance conditions on the Companys behalf. Subsequently, the obligation for the
amount payable was cancelled by the CROs resulting in a change in estimate and a one-time credit
of $125,000 to CPOS.
Cost of Preclinical eValuation services for the six months ended October 31, 2009 and 2008,
were $384,000 and $123,000, respectively, an increase of $261,000 or 212% reflecting the increase
in Preclinical eValuation revenues.
Research and development expenses for the six months ended October 31, 2009 and 2008, were
$1,141,000 and $649,000, respectively, an increase of $492,000 or 76%. This increase is primarily
due to the $175,000 charge for the final payment made with our common stock for the acquisition of
the SG-410 patent, the recognition of licensing fees, and costs in connection with our TAR-1
licensing agreement of $208,000 a $199,000 increase in tumorgraft acquisition and
testing costs, and offset by the cancelation of an amounts payable of $90,000 to certain vendors for lack of
performance.
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General and administrative expenses for the six months ended October 31, 2009 and 2008, were
$1,697,000 and $688,000, respectively, an increase of $1,009,000 or 147%. This increase is
primarily due to our continuing development of corporate infrastructure to support our increased
revenue generating activities of the Company including increased payroll, legal, accounting,
marketing, and office rent expenses.
Interest Income
Interest income for the six months ended October 31, 2009 and 2008 was $5,000 and $46,000,
respectively. The decrease in interest income resulted from the Companys decrease in assets held
in interest bearing investments.
Net Loss
The Companys net loss for the six months ended October 31, 2009 and 2008, was $1,587,000 and
$292,000, respectively. The $1,295,000 increase in our net loss for the six months ended October
31, 2009 reflects the $1,788,000 increase in operating expenses and a net decline of $41,000 in
interest income offset by the $534,000 increase in revenues.
Liquidity and Capital Resources
As of October 31, 2009, our source of liquidity was cash of $394,000 compared to $1,728,000
(exclusive of a $1,017,000 certificate of deposit) at April 30, 2009. Our cash decreased by
$1,334,000 during the six months ended October 31, 2009 due primarily to our use of cash in
operations of $2,132,000 offset by the conversion to cash of our $1,017,000 certificate of deposit
upon the maturity of that instrument. Additionally, we purchased property and equipment for
$32,000, treasury stock for $188,000, and received cash of $3,000 from the exercise of warrants to
purchase our common stock.
The Companys working capital, defined as current assets less current liabilities, as of
October 31, 2009 and April 30, 2009, was ($264,000) and $1,166,000, respectively.
Commitments and Contractual Obligations
There have been no material changes in our contractual obligations and other commercial
commitments other than in the ordinary course of business since the end of fiscal year 2009.
Information regarding our contractual obligations and commercial commitments is provided in our
Annual Report on Form 10-K for the year ended April 30, 2009.
Ability to Continue As a Going Concern
In June 2009 the Companys Board of Directors authorized management to begin the process of
raising additional capital. There can be no assurance that management will be successful in
raising capital on terms acceptable to the Company, if at all. The Companys ability to
successfully raise additional capital will depend on the condition of the capital markets and the
Companys financial condition and prospects. Even if the Company is able to successfully raise
additional capital, such capital could be in the form of debt and could be at high interest rates
and/or require the Company to comply with restrictive covenants that limit financial and business
activities. In addition, even if the Company is able to successfully raise equity capital, this
could dilute the interest of existing shareholders and/or be issued with preferential liquidation,
dividend or voting rights to those currently held by the Companys common stockholders.
Off Balance Sheet Arrangements
We have not entered into any transactions with unconsolidated entities whereby we have
financial guarantees, subordinated retained interests, derivative instruments or other contingent
arrangements that expose us to material continuing risk, contingent liabilities, or any other
obligation under a variable interest in an
unconsolidated entity that provides financing and liquidity support or market risk or credit risk
support to the Company.
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Item 3. |
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Quantitative and
Qualitative Disclosures About Market Risk. |
None
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Item 4T. |
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Controls and Procedures. |
Evaluation of Disclosure Controls and Procedures
It is managements responsibility to establish and maintain disclosure controls and
procedures as such term is defined in Rule 13a-15 under the Securities Exchange Act of 1934 (the
Exchange Act). Our management, including our principal executive officer and our chief financial
officer, have reviewed and evaluated the effectiveness of our disclosure controls and procedures as
of a date within ninety (90) days of the filing date of this Form 10-Q quarterly report. Following
this review and evaluation, management collectively determined that our disclosure controls and
procedures are not effective to ensure that information required to be disclosed by us in reports
that we file or submit under the Exchange Act (i) is recorded, processed, summarized and reported
within the time periods specified in SEC rules and forms, and (ii) is accumulated and communicated
to management, including our principlal executive officer and our chief financial officer, as
appropriate to allow timely decisions regarding required disclosure.
Changes in Internal Controls
There were no changes in our internal control over financial reporting in connection with the
evaluation required by Rule 13a-15(d) and 15d -15(d) of the Exchange Act that occurred during the
period covered by this Quarterly Report on Form 10-Q that have materially affected, or are
reasonably likely to materially affect, our internal control over financial reporting.
The Company continues to take steps to strengthen our system of internal control and
disclosure control procedures in regards to the four material weaknesses as further discussed in
our Annual Report on form 10-K for the fiscal year ended April 30, 2009.
17
PART II OTHER INFORMATION
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Item 1. |
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Legal Proceedings. |
From time to time we are involved in litigation incidental to the conduct of our business.
While the outcome of lawsuits and other proceedings against us cannot be predicted with certainty,
in the opinion of management, individually or in the aggregate, no such lawsuits are expected to
have a material effect on our financial position or results of operations.
We operate in a rapidly changing environment that involves a number of risks. The following
reference to risk factors noted in our Annual Report on Form 10-K highlights some of these risks
and others are discussed elsewhere in this report. These and other risks could materially and
adversely affect our business, financial condition, prospects, operating results or cash flows. For
a detailed discussion of the risk factors that should be understood by any investor contemplating
investment in our stock, please refer to Part I, Item 1A Risk Factors in our Annual Report on
Form 10-K for the fiscal year ended April 30, 2009.
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Item 2. |
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Unregistered Sales of Equity Securities and Use of Proceeds. |
None
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Item 3. |
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Defaults Upon Senior Securities. |
None
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Item 4. |
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Submission of Matters to a Vote of Security Holders. |
None
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Item 5. |
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Other Information. |
Douglas
D. Burkett, President and Principal Executive
Officer of the Company, has advised the Company that he will resign his position effective the close of business on
December 31, 2009. Dr. Burkett has agreed to serve as a consultant to the Company through June 7, 2009.
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Exhibit 31.1+
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Certification by the Principal Executive Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002 |
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Exhibit 31.2+
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Certification by the Chief Financial Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002 |
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Exhibit 32.1+
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Certification by the Principal Executive Officer and the 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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