Filed by Bowne Pure Compliance
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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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 September 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: 001-14907
IMMTECH PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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39-1523370 |
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(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
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One North End Avenue, New York, New York
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10282 |
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(Address of principal executive offices)
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(Zip Code) |
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Registrants telephone number: (212) 791-2911 |
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Former name, former address and former fiscal year, if changed since last report
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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.
Large accelerated filer o Accelerated filer þ Non-accelerated filer o Smaller reporting company o
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
November 7, 2008, 16,479,851 shares of the Registrants common stock, par value $0.01 per
share (Common Stock), were outstanding.
PART I. FINANCIAL INFORMATION
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Item 1. |
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Financial Statements. |
IMMTECH PHARMACEUTICALS, INC. AND SUBSIDIARIES
(A Development Stage Enterprise)
CONSOLIDATED BALANCE SHEETS (UNAUDITED)
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September 30, |
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March 31, |
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2008 |
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2008 |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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$ |
2,077,195 |
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$ |
5,996,157 |
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Restricted funds on deposit |
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952,500 |
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3,776,253 |
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Other receivables |
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54,205 |
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Other current assets |
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236,746 |
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253,014 |
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Total current assets |
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3,266,441 |
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10,079,629 |
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PROPERTY AND EQUIPMENT Net |
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67,748 |
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89,519 |
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PREPAID RENT |
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2,503,778 |
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3,234,314 |
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OTHER ASSETS |
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42,845 |
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34,142 |
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TOTAL |
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$ |
5,880,812 |
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$ |
13,437,604 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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CURRENT LIABILITIES: |
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Accounts payable |
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$ |
818,074 |
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$ |
2,938,511 |
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Accrued expenses |
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424,086 |
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499,770 |
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Deferred revenue |
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735,664 |
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2,399,676 |
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Total current liabilities |
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1,977,824 |
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5,837,957 |
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Total liabilities |
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1,977,824 |
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5,837,957 |
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STOCKHOLDERS EQUITY: |
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Preferred stock, par value $0.01 per share, 3,913,000
shares authorized and unissued as of September 30, 2008
and March 31, 2008 |
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Series A Convertible Preferred Stock, par value $0.01 per
share, stated value $25 per share, 320,000 shares
authorized, 32,500 and 50,500 shares issued and
outstanding as of September 30, 2008 and March 31, 2008,
respectively; aggregate liquidation preference of
$834,537 as of September 30, 2008 |
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834,537 |
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1,296,831 |
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Series B Convertible Preferred Stock, par value $0.01 per
share, stated value $25 per share, 240,000 shares
authorized, 9,464 and 11,464 shares issued and
outstanding as of September 30, 2008 and March 31, 2008,
respectively; aggregate liquidation preference of
$244,837 as of September 30, 2008 |
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244,837 |
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296,780 |
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Series C Convertible Preferred Stock, par value $0.01 per
share, stated value $25 per share, 160,000 shares
authorized, 45,536 shares issued and outstanding as of
September 30, 2008 and March 31, 2008; aggregate
liquidation preference of $1,180,594 as of September 30,
2008 |
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1,180,594 |
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1,180,345 |
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Series D Convertible Preferred Stock, par value $0.01 per
share, stated value $25 per share, 200,000 shares
authorized, 115,200 shares issued and outstanding as of
September 30, 2008 and March 31, 2008; aggregate
liquidation preference of $2,960,007 as of September 30,
2008 |
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2,960,007 |
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2,959,533 |
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Series E Convertible Preferred Stock, par value $0.01 per
share, stated value $25 per share, 167,000 shares
authorized, 97,800 and 98,600 shares issued and
outstanding as of September 30, 2008 and March 31, 2008,
respectively; aggregate liquidation preference of
$2,512,886 as of September 30, 2008 |
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2,512,886 |
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2,533,107 |
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Common stock, par value $0.01 per share, 100,000,000
shares authorized, 16,001,300 and 15,597,768 shares
issued and outstanding as of September 30, 2008 and March
31, 2008, respectively |
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160,013 |
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155,978 |
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Additional paid-in capital |
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111,516,707 |
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110,743,899 |
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Deficit accumulated during the developmental stage |
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(115,506,593 |
) |
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(111,566,826 |
) |
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Total stockholders equity |
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3,902,988 |
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7,599,647 |
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TOTAL |
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$ |
5,880,812 |
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$ |
13,437,604 |
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See notes to consolidated financial statements (unaudited).
- 1 -
IMMTECH PHARMACEUTICALS, INC. AND SUBSIDIARIES
(A Development Stage Enterprise)
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
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October 15, 1984 |
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Three Months Ended |
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Six Months Ended |
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(Inception) to |
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September 30, |
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September 30, |
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September 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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2008 |
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REVENUES |
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$ |
506,278 |
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$ |
1,030,333 |
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$ |
1,647,187 |
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$ |
1,856,682 |
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$ |
36,447,183 |
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EXPENSES: |
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Research and development |
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990,488 |
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2,282,839 |
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2,484,902 |
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4,200,651 |
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74,168,620 |
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General and administrative |
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1,268,409 |
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2,213,918 |
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2,192,651 |
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3,931,206 |
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75,269,963 |
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Asset impairment charge |
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693,073 |
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693,073 |
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693,073 |
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Other (litigation settlement) |
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(1,874,454 |
) |
Equity in loss of joint venture |
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135,002 |
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Total expenses |
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2,951,970 |
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|
4,496,757 |
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|
5,370,626 |
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8,131,857 |
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148,392,204 |
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LOSS FROM OPERATIONS |
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(2,445,692 |
) |
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|
(3,466,424 |
) |
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(3,723,439 |
) |
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|
(6,275,175 |
) |
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(111,945,021 |
) |
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OTHER INCOME (EXPENSE): |
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Interest income |
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10,784 |
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132,242 |
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31,752 |
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280,005 |
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1,945,328 |
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Interest expense |
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(1,129,502 |
) |
Loss on sales of investment securities net |
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(2,942 |
) |
Cancelled offering costs |
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(584,707 |
) |
Gain on extinguishment of debt |
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1,427,765 |
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Other income |
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10,784 |
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132,242 |
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31,752 |
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280,005 |
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1,655,942 |
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NET LOSS |
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|
(2,434,908 |
) |
|
|
(3,334,182 |
) |
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(3,691,687 |
) |
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|
(5,995,170 |
) |
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|
(110,289,079 |
) |
CONVERTIBLE PREFERRED STOCK DIVIDENDS AND CONVERTIBLE
PREFERRED STOCK PREMIUM DEEMED DIVIDENDS |
|
|
(121,665 |
) |
|
|
(134,982 |
) |
|
|
(248,080 |
) |
|
|
(269,979 |
) |
|
|
(7,587,413 |
) |
REDEEMABLE PREFERRED STOCK CONVERSION, PREMIUM
AMORTIZATION AND DIVIDENDS |
|
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|
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|
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|
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|
|
|
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|
2,369,899 |
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NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS |
|
$ |
(2,556,573 |
) |
|
$ |
(3,469,164 |
) |
|
$ |
(3,939,767 |
) |
|
$ |
(6,265,149 |
) |
|
$ |
(115,506,593 |
) |
|
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BASIC AND DILUTED NET LOSS PER SHARE ATTRIBUTABLE TO
COMMON STOCKHOLDERS: |
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Net loss |
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$ |
(0.15 |
) |
|
$ |
(0.22 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.39 |
) |
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|
|
Convertible preferred stock dividends and convertible
preferred stock premium deemed dividends |
|
|
(0.01 |
) |
|
|
(0.01 |
) |
|
|
(0.02 |
) |
|
|
(0.02 |
) |
|
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BASIC AND DILUTED LOSS PER SHARE ATTRIBUTABLE
TO COMMON STOCKHOLDERS |
|
$ |
(0.16 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.25 |
) |
|
$ |
(0.41 |
) |
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WEIGHTED AVERAGE SHARES USED IN COMPUTING
BASIC AND DILUTED NET LOSS PER SHARE |
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|
15,980,742 |
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15,409,787 |
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15,914,173 |
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15,390,029 |
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|
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See notes to consolidated financial statements (unaudited).
- 2 -
IMMTECH PHARMACEUTICALS, INC. AND SUBSIDIARIES
(A Development Stage Enterprise)
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
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October 15, |
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1984 |
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Three Months Ended |
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Six Months Ended |
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(Inception) to |
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|
September 30, |
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|
September 30, |
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
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|
2008 |
|
OPERATING ACTIVITIES: |
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Net loss |
|
$ |
(2,434,908 |
) |
|
$ |
(3,334,182 |
) |
|
$ |
(3,691,687 |
) |
|
$ |
(5,995,170 |
) |
|
$ |
(110,289,079 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Compensation recorded related to issuance of common stock,
common stock options and warrants |
|
|
285,437 |
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|
901,158 |
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(4,908 |
) |
|
|
1,393,951 |
|
|
|
33,859,879 |
|
Depreciation and amortization of property and equipment |
|
|
30,984 |
|
|
|
36,387 |
|
|
|
63,298 |
|
|
|
73,500 |
|
|
|
1,396,535 |
|
(Gain)/Loss on disposal of fixed assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,982 |
|
Equity in loss of joint venture |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
135,002 |
|
Asset impairment charge |
|
|
693,073 |
|
|
|
|
|
|
|
693,073 |
|
|
|
|
|
|
|
693,073 |
|
Loss on sales of investment securities net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,942 |
|
Amortization of debt discounts and issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
134,503 |
|
Gain on extinguishment of debt |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,427,765 |
) |
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other receivables |
|
|
|
|
|
|
|
|
|
|
54,205 |
|
|
|
|
|
|
|
|
|
Other current assets |
|
|
138,698 |
|
|
|
104,701 |
|
|
|
16,268 |
|
|
|
(300,445 |
) |
|
|
(236,746 |
) |
Other assets |
|
|
(8,703 |
) |
|
|
(118,421 |
) |
|
|
(8,703 |
) |
|
|
(296,052 |
) |
|
|
(42,845 |
) |
Accounts payable |
|
|
(632,787 |
) |
|
|
61,192 |
|
|
|
(2,120,437 |
) |
|
|
(1,158,657 |
) |
|
|
1,145,609 |
|
Accrued expenses |
|
|
(106,900 |
) |
|
|
(169,073 |
) |
|
|
(75,684 |
) |
|
|
(123,847 |
) |
|
|
1,087,099 |
|
Deferred revenue |
|
|
(508,658 |
) |
|
|
(1,099,412 |
) |
|
|
(1,664,012 |
) |
|
|
1,064,370 |
|
|
|
735,664 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(2,543,764 |
) |
|
|
(3,617,650 |
) |
|
|
(6,738,587 |
) |
|
|
(5,342,350 |
) |
|
|
(72,800,147 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment |
|
|
(1,353 |
) |
|
|
|
|
|
|
(4,064 |
) |
|
|
|
|
|
|
(1,640,186 |
) |
Restricted funds on deposit |
|
|
1,048,600 |
|
|
|
988,556 |
|
|
|
2,823,752 |
|
|
|
2,425,035 |
|
|
|
(952,501 |
) |
Advances to joint venture |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(135,002 |
) |
Proceeds from maturities of investment securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,800,527 |
|
Purchases of investment securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,803,469 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
1,047,247 |
|
|
|
988,556 |
|
|
|
2,819,688 |
|
|
|
2,425,035 |
|
|
|
(2,730,631 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Advances from stockholders and affiliates |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
985,172 |
|
Proceeds from issuance of notes payable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,645,194 |
|
Principal payments on notes payable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(218,119 |
) |
Payments for debt issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(53,669 |
) |
Payments for extinguishment of debt |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(203,450 |
) |
Net proceeds from issuance of redeemable preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,330,000 |
|
Net proceeds from issuance of convertible preferred stock and warrants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,085,434 |
|
Payments of convertible preferred stock dividends and for fractional
shares of common stock resulting from the conversions of convertible
preferred stock |
|
|
|
|
|
|
(17 |
) |
|
|
(63 |
) |
|
|
(466 |
) |
|
|
(6,638 |
) |
Net proceeds from issuance of common stock |
|
|
|
|
|
|
295,911 |
|
|
|
|
|
|
|
295,911 |
|
|
|
53,798,490 |
|
Additional capital contributed by stockholders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
245,559 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities |
|
|
|
|
|
|
295,894 |
|
|
|
(63 |
) |
|
|
295,445 |
|
|
|
77,607,973 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
|
|
(1,496,517 |
) |
|
|
(2,333,200 |
) |
|
|
(3,918,962 |
) |
|
|
(2,621,870 |
) |
|
|
2,077,195 |
|
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD |
|
|
3,573,712 |
|
|
|
12,173,125 |
|
|
|
5,996,157 |
|
|
|
12,461,795 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS, END OF PERIOD |
|
$ |
2,077,195 |
|
|
$ |
9,839,925 |
|
|
$ |
2,077,195 |
|
|
$ |
9,839,925 |
|
|
$ |
2,077,195 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See notes to consolidated financial statements (unaudited).
- 3 -
IMMTECH PHARMACEUTICALS, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE ENTERPRISE)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
The accompanying consolidated financial statements have been prepared by Immtech
Pharmaceuticals, Inc. and its subsidiaries (the Company or Immtech) pursuant to the
rules and regulations of the Securities and Exchange Commission (SEC) and, in the opinion
of management, include all adjustments necessary for a fair statement of results for each
period shown (unless otherwise noted herein, all adjustments are of a normal recurring
nature). Certain information and footnote disclosures normally included in financial
statements prepared in accordance with accounting principles generally accepted in the
United States of America have been condensed or omitted pursuant to such SEC rules and
regulations. The Company, with a fiscal year ending March 31, believes that the disclosures
made are adequate to prevent the financial information given from being misleading. It is
suggested that these financial statements be read in conjunction with the financial
statements and notes thereto included in the Companys latest Annual Report on Form 10-K.
2. |
|
COMPANY BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
Description of Business Immtech Pharmaceuticals, Inc. and subsidiaries (a development
stage enterprise) is focused on global opportunities in the healthcare sector and
opportunities in China. Immtech aims to leverage its established expertise and other assets
in both new drug sales and enhanced healthcare-related services, including research and
information-providing services, for developed and developing countries. We plan to further
our focus on the discovery and development of drugs to treat infectious diseases. In
addition to our internal drug discovery program, we plan to partner with local institutions
to provide contract research services (CRS) in China.
During the year ended March 31, 2008, the Companys drug development program for
pafuramidine was discontinued due to findings of renal and liver adverse events among
participants in the study of healthy volunteers conducted in South Africa. It was halted in
December 2007 after several subjects developed abnormal liver function. The program was
formally discontinued in February 2008 when five subjects in the same study developed renal
abnormalities that required medical intervention and hospitalization.
The Company holds worldwide patents and patent applications, and licenses and rights to
license technology, primarily from a scientific consortium that has granted to the Company
exclusive rights to commercialize products from, and license rights to the technology. The
scientific consortium includes scientists from The University of North Carolina at Chapel
Hill (UNC-CH), Georgia State University (Georgia State), Duke University and Auburn
University (collectively, the Scientific Consortium). The Company is a development stage
enterprise and, since its inception on October 15, 1984,
has engaged in research and development programs, expanded its network of scientists and
scientific advisors and licensing technology agreements, and worked to commercialize the
aromatic cation pharmaceutical technology platform. (The Company acquired its rights to the
aromatic cation technology platform in 1997 and promptly thereafter commenced development of
its current programs.) The Company uses the expertise and resources of strategic partners
and third parties in a number of areas, including: (i) laboratory research, (ii) animal and
human trials and (iii) the manufacturing of pharmaceutical drugs.
- 4 -
The Company does not have any products currently available for sale, and no products are
expected to be commercially available for sale until after March 31, 2009, if at all.
The Company also intends to increase its presence in China by: (i) bringing approved drugs,
health products and services from developed markets to China for sales and distribution, and
(ii) partnering with local Chinese institutions to provide CRS to other international
companies involved in drug development.
Going Concern Presentation and Related Risks and Uncertainties The accompanying 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.
Since inception, the Company has incurred accumulated net losses of approximately
$110,289,000. Management expects the Company will continue to incur significant losses
during the next several years as the Company continues development activities, clinical
trials and commercialization efforts. In addition, the Company has various research and
development agreements with third parties and is dependent upon such parties abilities to
perform under these agreements. There can be no assurance that the Companys activities
will lead to the development of commercially viable products. The Companys operations to
date have consumed substantial amounts of cash. The negative cash flow from operations is
expected to continue in the foreseeable future. The Company believes it will require
substantial additional funds to commercialize its drug candidates. The Companys cash
requirements may vary materially from those now planned when and if the following become
known: formation and development of relationships with strategic partners, changes in the
focus and direction of development programs, results of research and development efforts,
results of clinical testing, responses to grant requests, competitive and technological
advances, requirements in the regulatory process and other factors. Changes in
circumstances in any results of our new global business initiatives may require the Company
to allocate substantially more funds than are currently available or than management intends
to raise.
The Company
believes its existing unrestricted cash and cash equivalents, and the grants the
Company has received or has been awarded, will be sufficient to meet the Companys planned
expenditures through January 2009, and through the sale of land
use rights in Shenzhen, China, capital resources
will be sufficient to support our operations through June 30, 2009, although there can be no
assurance the Company will not require additional funds. The decision to terminate the
pafuramidine development program has significantly depressed the Companys stock price and
impaired its ability to raise additional funds. The
Company is evaluating its strategic alternatives with respect to all aspects of the
business. These factors, among others, indicate that the Company may be unable to continue
as a going concern. The accompanying financial statements do not include any adjustments
that might result from the outcome of these uncertainties.
- 5 -
The Company’s cash resources
have been used to finance, develop and begin commercialization of drug product
candidates, including sponsored research, conducting human clinical trials,
capital expenditures, expenses associated with development of product
candidates pursuant to the Consortium Agreement, and, as contemplated by the
Consortium Agreement, under the License Agreement with the Scientific
Consortium, and general and administrative expenses. Over the next several
years the Company expects to incur substantial additional research and
development costs, including costs related to research in pre-clinical
(laboratory) and human clinical trials, administrative expenses to support
our research and development operations and marketing expenses to launch the
sale of any commercialized product that may be developed.
The Company’s future working
capital requirements will depend upon numerous factors, including the progress
of research, development and commercialization programs (which may vary as
product candidates are added or abandoned), results of pre-clinical testing and
human clinical trials, achievement of regulatory milestones, third party
collaborators fulfilling their obligations to the Company, the timing and cost
of seeking regulatory approvals, the level of resources that the Company
devotes to the engagement or development of manufacturing capabilities, the
Company’s ability to maintain existing and to establish new collaborative
arrangements with others to provide funding to support these activities, and
other factors. In any event, the Company will require substantial additional
funds in addition to its existing resources to develop product candidates and
to otherwise meet its business objectives.
The Company believes its existing
unrestricted cash and cash equivalents and the grants it has received or has
been awarded and is awaiting disbursement of, will be sufficient to meet its
planned expenditures through at least January 2009, although there can be
no assurance the Company will not require additional funds.
Principles of Consolidation The consolidated financial statements include the accounts of
Immtech Pharmaceuticals, Inc. and its wholly owned subsidiaries. All intercompany balances
and transactions have been eliminated.
Cash and Cash Equivalents The Company considers all highly liquid investments with a
maturity of three months or less when purchased to be cash equivalents. Cash and cash
equivalents consist of an amount on deposit at a bank and an investment in a money market
mutual fund, stated at cost, which approximates fair value.
Restricted Funds on Deposit Restricted funds on deposit consist of cash on deposit at a
bank which are restricted for use in accordance with a clinical research subcontract
agreement with UNC-CH.
Concentration of Credit Risk The Company maintains its cash in commercial banks.
Balances on deposit are insured by the Federal Deposit Insurance Corporation (FDIC) up to
specified limits.
Investment The Company accounts for its investment in NextEra Therapeutics, Inc.
(NextEra) on the equity method. As of September 30, 2008 and March 31, 2008, the Company
owned approximately 28% of the issued and outstanding shares of NextEra common stock. The
Company has recognized an equity loss in NextEra to the extent of the basis of its
investment, and the investment balance is zero as of September 30, 2008 and March 31, 2008.
Recognition of any investment income on the equity method by the Company for its investment
in NextEra will occur only after NextEra has earnings in excess of previously unrecognized
equity losses. The Company does not provide, and has not provided, any financial guarantees
to NextEra.
Property and Equipment Property and equipment are recorded at cost and depreciated and
amortized using the straight-line method over the estimated useful lives of the respective
assets, ranging from three to five years. Leasehold improvements are amortized over the
lesser of the life of the related lease or their useful lives.
Prepaid Rent Prepaid rent relates to land use rights that the Company has recorded at
cost and amortized using the straight-line method over the estimated useful life of fifty
years.
- 6 -
Long-Lived Assets The Company periodically evaluates the carrying value of its property
and equipment. Long-lived assets are reviewed for impairment whenever events or changes in
circumstances indicate that the carrying amount may not be recoverable. If the sum of the
expected future undiscounted cash flows is less than the carrying amount of an asset, a loss
is recognized for the asset which is measured by the difference between the fair value and
the carrying value of the asset.
During the second quarter of fiscal
year 2009, the Company recorded a non-cash asset impairment charge related to
the land use rights in Shenzhen, China in the amount of $693,073. The changes
result from the volatility and disruption of the capital and credit markets and
adverse changes in the global economy.
Revenue Recognition Grants to perform research have been the Companys primary source of
revenue and are generally granted to support research and development activities for
specific projects or drug candidates. Revenue related to grants to perform research and
development is recognized as earned based on the performance requirements of the specific
grant. Upfront cash payments from research and development grants are reported as deferred
revenue until such time as the research and development activities covered by the grant are
performed.
Revenue from licensing arrangements is recorded when earned based on the performance
requirements of the contract. Nonrefundable upfront license fees, for product candidates
where the Company is providing continuing services related to product development, are
deferred and recognized as revenue over the development period or as the Company provides
services required under the agreement. The timing and amount of revenue the Company
recognizes from licenses, either from upfront fees or milestones where the Company is
providing continuing services related to product development, is dependent upon the
Companys estimates of filing dates. As product candidates move through the development
process, it is necessary to revise these estimates to consider changes to the product
development cycle, such as changes in the clinical development plan, regulatory
requirements, or various other factors, many of which may be outside of the Companys
control. The impact on revenue changes in the Companys estimates and the timing thereof,
is recognized prospectively over the remaining estimated product development period.
Research and Development Costs Research and development costs are expensed as incurred
and include costs associated with research performed pursuant to collaborative agreements.
Research and development costs consist of direct and indirect internal costs related to
specific projects as well as fees paid to other entities that conduct certain research
activities on the Companys behalf.
Income Taxes The Company accounts for income taxes using an asset and liability approach.
Deferred income tax assets and liabilities are computed annually for differences between
the financial statement and tax bases of assets and liabilities that will result in taxable
or deductible amounts in the future based on enacted tax laws and rates applicable to the
periods in which the differences are expected to affect taxable income. In addition, a
valuation allowance is recognized if it is more likely than not that some or all of the
deferred income tax assets will not be realized. A valuation allowance is used to offset
the related net deferred income tax assets due to uncertainties of realizing the benefits of
certain net operating loss and tax credit carry-forwards and other deferred income tax
assets.
- 7 -
Net Income (Loss) Per Share Net income (loss) per share is calculated in accordance with
Statement of Financial Accounting Standard (SFAS) No. 128, Earnings Per Share. Basic
net income (loss) and diluted net income (loss) per share are computed by dividing net
income (loss) attributable to common stockholders by the weighted average number of common
shares outstanding. Diluted net income per share, when applicable, is computed by dividing
net income attributable to common stockholders by the weighted average number of common
shares outstanding increased by the number of potential dilutive common shares based on the
treasury stock method. Diluted net loss per share was the same as the basic net loss per
share for the three and six month periods ended September 30, 2008 and September 30, 2007,
as none of the Companys outstanding common stock options, warrants and the conversion
features of Series A, B, C, D and E Convertible Preferred Stock were dilutive.
Stock-Based Compensation Effective April 1, 2006, the Company adopted SFAS No. 123(R),
Share-Based Payment, (SFAS 123(R)) using the modified prospective method. SFAS 123(R)
requires entities to recognize the cost of employee services in exchange for awards of
equity instruments based on the grant-date fair value of those awards (with limited
exceptions). The cost, based on the estimated number of awards that are expected to vest,
will be recognized over the period during which the employee is required to provide the
services in exchange for the award. No compensation cost is recognized for awards for which
employees do not render the requisite service. Upon adoption, the grant-date fair value of
employee share options and similar instruments was estimated using the Black-Scholes
valuation model. The Black-Scholes valuation requires the input of highly subjective
assumptions, including the expected life of the stock-based award and stock price
volatility. The assumptions used are managements best estimates, but the estimates involve
inherent uncertainties and the application of managements judgment. As a result, if other
assumptions had been used, the recorded and pro forma stock-based compensation expense could
have been materially different from that depicted in the financial statements.
Fair Value of Financial Instruments The Company believes that the carrying amount of its
financial instruments (cash and cash equivalents, restricted funds on deposit, accounts
payable and accrued expenses) approximates the fair value of such instruments as of
September 30, 2008 and March 31, 2008 based on the short-term nature of the instruments.
Segment Reporting The Company is a development stage pharmaceutical company that operates
as one segment.
Comprehensive Loss There were no differences between comprehensive loss and net loss for
the three and six month periods ended September 30, 2008 and 2007, respectively.
Use of Estimates The preparation of financial statements in conformity with accounting
principles generally accepted in the United States of America 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 revenues and expenses during the reporting period. Actual
results could differ materially from these estimates.
- 8 -
New Accounting Standard The Company adopted Financial Accounting Standards Board
(FASB), Interpretation No. 48, Accounting for Uncertainty in Income Taxes, (FIN 48) on
April 1, 2007. The adoption of FIN 48 did not have an impact. At the adoption date and as
of September 30, 2008, the Company does not have a liability for uncertain tax benefits.
The Company does not presently expect any reasonably possible material change to the
estimated amount of liability associated with its uncertain tax positions during the next
twelve months. Additionally, there were no interest or penalties related to income taxes
that have been accrued or recognized for open tax years.
The Company files income tax returns in the U.S. federal jurisdiction, and various state
jurisdictions. Periods subject to examination for the Companys federal tax return are the
1991 through 2007 tax years. In addition, open tax years related to state jurisdictions
remain subject to examination but are not considered material.
New Accounting Standard In December 2007, the FASB issued Statement No. 141 (revised
2007), Business Combinations (SFAS 141(R)). SFAS 141(R) changes the requirements for an
acquirers recognition and measurement of the assets acquired and the liabilities assumed in
a business combination. SFAS 141(R) is effective for us in fiscal year 2009. The impact of
SFAS 141(R) will depend on future acquisitions.
New Accounting Standard In September 2006, the FASB issued Statement No. 157 (SFAS
157), Fair Value Measurements. SFAS 157 defines fair value, establishes a framework for
measuring fair value in accordance with generally accepted accounting principles, and
expands disclosures about fair value measurements. Subsequently in February 2008, the FASB
issued FASB Staff Position 157-1, Application of FASB Statement No. 157 to FASB Statement
No. 13 and Other Accounting Pronouncements That Address Fair Value Measurements for Purposes
of Lease Classification or Measurement under Statement 13 (FSP 157-1) and FASB Staff
Position 157-2, Partial Deferral of the Effective Date of Statement 157 (FSP 157-2).
FSP 157-1 removed leasing transactions accounted for under Statement No. 13 and related
guidance from the scope of SFAS 157. FSP 157-2 deferred the effective date of SFAS 157 for
all nonfinancial assets and nonfinancial liabilities to fiscal years beginning after
November 15, 2008. SFAS 157 is effective for us in fiscal year 2009. The impact of
adoption has not been material.
New Accounting Standard In February 2007, the FASB issued Statement No. 159 (SFAS 159),
Fair Value Option for Financial Assets and Financial Liabilities. SFAS 159 establishes
the irrevocable option to elect to carry certain financial assets and liabilities at fair
value, with changes in fair value recorded in earnings. SFAS 159 is effective for us in
fiscal year 2009. The Company has assessed the standard and will not elect the fair value
option.
- 9 -
New Accounting Standard In December 2007, the FASB issued Statement No. 160,
Non-controlling Interests in Consolidated Financial Statements, an amendment of ARB
No. 51 (SFAS 160). SFAS 160 requires that (a) non-controlling (minority) interests be
reported as a component of shareholders equity, (b) net income attributable to the parent
and to the non-controlling interest be separately identified in the consolidated statement
of operations, (c) changes in a parents ownership interest while the parent retains its
controlling interest be accounted for as equity transactions, (d) any retained
non-controlling equity investment upon the deconsolidation of a subsidiary be initially
measured at fair value, and (e) sufficient disclosures are provided that clearly identify
and distinguish between the interests of the parent and the interests of the non-controlling
owners. SFAS 160 is effective for us in fiscal year 2009 and should be applied
prospectively. However, the presentation and disclosure requirements of the statement shall
be applied retrospectively for all periods presented. The Company does not expect the
impact of adoption to be material.
On January 7, 2004, the stockholders of the Company approved an increase in the number of
authorized common stock from 30 million to 100 million shares. On June 14, 2004, the
Company filed with the Secretary of State of the State of Delaware an Amended and Restated
Certificate of Incorporation implementing, among other things, the approved authorized 70
million share common stock increase from 30 million to 100 million shares of common stock.
Series A Convertible Preferred Stock On February 14, 2002, the Company filed a
Certificate of Designation with the Secretary of State of the State of Delaware designating
320,000 shares of the Companys 5,000,000 authorized shares of preferred stock as Series A
Convertible Preferred Stock, $0.01 par value, with a stated value of $25.00 per share.
Dividends accrue at a rate of 6.0% per annum on the $25.00 stated value per share and are
payable semi-annually on April 15 and October 15 of each year while the shares are
outstanding. The Company has the option to pay the dividend either in cash or in equivalent
shares of common stock, as defined. Included in the carrying value of the Series A
Convertible Preferred Stock in the accompanying consolidated balance sheets are $22,037 and
$34,331 of accrued preferred stock dividends at September 30, 2008 and March 31, 2008,
respectively. Each share of Series A Convertible Preferred Stock may be converted by the
holder at any time into shares of our common stock at a conversion rate determined by
dividing the $25.00 stated value, plus any accrued and unpaid dividends (the Liquidation
Price A), by a $4.42 conversion price (the Conversion Price A), subject to certain
adjustments, as defined in the Series A Certificate of Designation. On April 15, 2007, the
Company issued 6,308 shares of common stock and paid $87 in lieu of fractional common shares
as dividends on the preferred shares. On April 15, 2008, the Company issued 40,686 shares
of common stock and paid $15 in lieu of fractional common shares as dividends on the
preferred shares. During the three and six month periods ended September 30, 2007 certain
preferred stockholders converted 1,000 shares of Series A Convertible Preferred Stock,
including accrued dividends, for 5,701 shares of common stock. During the three and six
month periods ended September 30, 2008 certain preferred stockholders converted 10,000 and
18,000 shares of Series A Convertible Preferred Stock, including accrued dividends, for
61,012 and 108,153 shares of common stock, respectively.
- 10 -
The Company may at any time require that any or all outstanding shares of Series A
Convertible Preferred Stock be converted into shares of the Companys common stock, provided
that the shares of common stock into which the Series A Convertible Preferred Stock are
convertible are registered pursuant to an effective registration statement, as defined. The
number of shares of common stock to be received by the holders of the Series A Convertible
Preferred Stock upon a mandatory conversion by the Company is determined by (i) dividing the
Liquidation Price A by the Conversion Price A, provided that the closing bid price for the
Companys common stock exceeds $9.00 for 20 consecutive trading days within 180 days prior
to notice of conversion, as defined, or (ii) if the requirements of (i) are not met, the
number of shares of common stock is determined by dividing 110% of the Liquidation Price A
by the Conversion Price A. The Conversion Price A is subject to certain adjustments, as
defined in the Series A Certificate of Designation.
The Company may at any time, upon 30 days notice, redeem any or all outstanding shares of
the Series A Convertible Preferred Stock by payment of the Liquidation Price A to the holder
of such shares, provided that the holder does not convert the Series A Convertible Preferred
Stock into shares of common stock during the 30 day period. The Series A Convertible
Preferred Stock has a preference in liquidation equal to $25.00 per share, plus any accrued
and unpaid dividends, over the common stock and is pari passu with all other outstanding
series of preferred stock. Each issued and outstanding share of Series A Convertible
Preferred Stock shall be entitled to 5.6561 votes (subject to adjustment) with respect to
any and all matters presented to the Companys stockholders for their action or
consideration. Except as provided by law or by the provisions establishing any other series
of preferred stock, holders of Series A Convertible Preferred Stock and holders of any other
outstanding preferred stock shall vote together with the holders of common stock as a single
class.
Series B Convertible Preferred Stock On September 25, 2002, the Company filed a
Certificate of Designation with the Secretary of State of the State of Delaware designating
240,000 shares of the Companys 5,000,000 authorized shares of preferred stock as Series B
Convertible Preferred Stock, $0.01 par value, with a stated value of $25.00 per share.
Dividends accrue at a rate of 8.0% per annum on the $25.00 stated value per share and are
payable semi-annually on April 15 and October 15 of each year while the shares are
outstanding. The Company has the option to pay the dividend either in cash or in equivalent
shares of common stock, as defined. Included in the carrying value of the Series B
Convertible Preferred Stock in the accompanying consolidated balance sheets are $8,237 and
$10,180 of accrued preferred stock dividends as of September 30, 2008 and March 31, 2008,
respectively. Each share of Series B Convertible Preferred Stock may be converted by the
holder at any time into shares of common stock at a conversion rate determined by dividing
the $25.00 stated value, plus any accrued and unpaid dividends (the Liquidation Price B),
by a $4.00 conversion price (the Conversion Price B), subject to certain adjustments, as
defined in the Series B Certificate of Designation. On April 15, 2007, the Company issued
2,040 shares of common stock and paid $30 in lieu of fractional common shares as dividends
on the preferred shares. On April 15, 2008, the Company issued 12,316 shares of common
stock and paid $3 in lieu of fractional common shares as dividends on the preferred
shares. During the three and six month periods ended September 2007, there were no
conversions. During the three month period ended September 30, 2008, there were no
conversions. During the six month period ended September 30, 2008, a preferred shareholder
converted 2,000 shares of Series B Convertible Preferred Stock, including accrued dividends,
for 13,129 shares of common stock.
- 11 -
The Company may at any time require that any or all outstanding shares of Series B
Convertible Preferred Stock be converted into shares of the Companys common stock, provided
that the shares of common stock into which the Series B Convertible Preferred Stock are
convertible are registered pursuant to an effective registration statement, as defined. The
number of shares of common stock to be received by the holders of the Series B Convertible
Preferred Stock upon a mandatory conversion by the Company is determined by (i) dividing the
Liquidation Price B by the Conversion Price B, provided that the closing bid price for the
Companys common stock exceeds $9.00 for 20 consecutive trading days within 180 days prior
to notice of conversion, as defined, or (ii) if the requirements of (i) are not met, the
number of shares of common stock is determined by dividing 110% of the Liquidation Price B
by the Conversion Price B. The Conversion Price B is subject to certain adjustments, as
defined in the Series B Certificate of Designation.
The Company may at any time, upon 30 days notice, redeem any or all outstanding shares of
the Series B Convertible Preferred Stock by payment of the Liquidation Price B to the holder
of such shares, provided that the holder does not convert the Series B Convertible Preferred
Stock into shares of common stock during the 30 day period. The Series B Convertible
Preferred Stock has a preference in liquidation equal to $25.00 per share, plus any accrued
and unpaid dividends over the common stock and is pari passu with all other outstanding
series of preferred stock. Each issued and outstanding share of Series B Convertible
Preferred Stock shall be entitled to 6.25 votes (subject to adjustment) with respect to any
and all matters presented to the Companys stockholders for their action or consideration.
Except as provided by law or by the provisions establishing any other series of preferred
stock, holders of Series B Convertible Preferred Stock and holders of any other outstanding
preferred stock shall vote together with the holders of common stock as a single class.
Series C Convertible Preferred Stock On June 6, 2003, we filed a Certificate of
Designation with the Secretary of State of the State of Delaware designating 160,000 shares
of the Companys 5,000,000 authorized shares of preferred stock as Series C Convertible
Preferred Stock, $0.01 par value, with a stated value of $25.00 per share. Dividends accrue
at a rate of 8.0% per annum on the $25.00 stated value per share and are payable
semi-annually on April 15 and October 15 of each year while the shares are outstanding. The
Company has the option to pay the dividend either in cash or in equivalent shares of common
stock, as defined. Included in the carrying value of the Series C Convertible Preferred
Stock in the accompanying consolidated balance sheets are $42,194 and $41,945 of accrued
preferred stock dividends as of September 30, 2008 and March 31, 2008, respectively. Each
share of Series C Convertible Preferred Stock may be converted by the holder at any time
into shares of common stock at a conversion rate determined by dividing the $25.00 stated
value, plus any accrued and unpaid
dividends (the Liquidation Price C), by a $4.42 conversion price (the Conversion Price
C), subject to certain adjustments, as defined in the Series C Certificate of Designation.
On April 15, 2007, the Company issued 6,900 shares of common stock and paid $99 in lieu of
fractional common shares as dividends on the preferred shares. On April 15, 2008, the
Company issued 48,919 shares of common stock and paid $14 in lieu of fractional common
shares as dividends on the preferred shares. During the three and six month periods ended
September 30, 2008 and 2007, there were no conversions.
- 12 -
The Company may at any time require that any or all outstanding shares of Series C
Convertible Preferred Stock be converted into shares of the Companys common stock, provided
that the shares of common stock into which the Series C Convertible Preferred Stock are
convertible are registered pursuant to an effective registration statement, as defined. The
number of shares of common stock to be received by the holders of the Series C Convertible
Preferred Stock upon a mandatory conversion by the Company is determined by (i) dividing the
Liquidation Price C by the Conversion Price C provided that the closing bid price for the
Companys common stock exceeds $9.00 for 20 consecutive trading days within 180 days prior
to notice of conversion, as defined, or (ii) if the requirements of (i) are not met, the
number of shares of common stock is determined by dividing 110% of the Liquidation Price C
by the Conversion Price C. The Conversion Price C is subject to certain adjustments, as
defined in the Series C Certificate of Designation.
The Company may at any time, upon 30 days notice, redeem any or all outstanding shares of
the Series C Convertible Preferred Stock by payment of the Liquidation Price C to the holder
of such shares, provided that the holder does not convert the Series C Convertible Preferred
Stock into shares of common stock during the 30 day period. The Series C Convertible
Preferred Stock has a preference in liquidation equal to $25.00 per share, plus any accrued
and unpaid dividends, over the common stock and is pari passu with all other outstanding
series of preferred stock. Each issued and outstanding share of Series C Convertible
Preferred Stock shall be entitled to 5.6561 votes (subject to adjustment) with respect to
any and all matters presented to the Companys stockholders for their action or
consideration. Except as provided by law or by the provisions establishing any other series
of preferred stock, holders of Series C Convertible Preferred Stock and holders of any other
outstanding preferred stock shall vote together with the holders of common stock as a single
class.
Series D Convertible Preferred Stock On January 15, 2004, the Company filed a Certificate
of Designation with the Secretary of State of the State of Delaware designating 200,000
shares of the Companys 5,000,000 authorized shares of preferred stock as Series D
Convertible Preferred Stock, $0.01 par value, with a stated value of $25.00 per share.
Dividends accrue at a rate of 6.0% per annum on the $25.00 stated value per share and are
payable semi-annually on April 15 and October 15 of each year while the shares are
outstanding. The Company has the option to pay the dividend either in cash or in equivalent
shares of common stock, as defined. Included in the carrying value of the Series D
Convertible Preferred Stock in the accompanying consolidated balance sheets are $80,007 and
$79,533 of accrued preferred stock dividends as of September 30, 2008 and March 31, 2008,
respectively.
- 13 -
Each share of Series D
Convertible Preferred Stock may be converted by the holder at any time into shares of common
stock at a conversion rate determined by dividing the $25.00 stated value, plus any accrued
and unpaid dividends (the Liquidation Price D), by a $9.00 conversion price (the
Conversion Price D), subject to certain adjustments, as defined in the Series D
Certificate of Designation. On April 15, 2007, the Company issued 13,334 shares of common
stock and paid $95 in lieu of fractional common shares as dividends on the preferred shares.
On April 15, 2008, the Company issued 92,831 shares of common stock and paid $16 in lieu of
fractional common shares as dividends on the preferred shares. During the three and six
month periods ended September 30, 2007 certain preferred stockholders converted 2,000 shares
of Series D Convertible Preferred Stock, including accrued dividends, for 5,653 shares of
common stock, respectively. During the three and six month periods ended September 30, 2008
there were no conversions.
The Company may at any time, require that any or all outstanding shares of Series D
Convertible Preferred Stock be converted into shares of our common stock, provided that the
shares of common stock into which the Series D Convertible Preferred Stock are convertible
are registered pursuant to an effective registration statement, as defined. The number of
shares of common stock to be received by the holders of the Series D Convertible Preferred
Stock upon a mandatory conversion by the Company is determined by (i) dividing the
Liquidation Price D by the Conversion Price D provided that the closing bid price for the
Companys common stock exceeds $18.00 for 20 consecutive trading days within 180 days prior
to notice of conversion, as defined, or (ii) if the requirements of (i) are not met, the
number of shares of common stock is determined by dividing 110% of the Liquidation Price D
by the Conversion Price D. The Conversion Price D is subject to certain adjustments, as
defined in the Certificate of Designation.
The Series D Convertible Preferred Stock has a preference in liquidation equal to $25.00 per
share, plus any accrued and unpaid dividends, over the common stock and is pari passu with
all other series of preferred stock. Each issued and outstanding share of Series D
Convertible Preferred Stock shall be entitled to 2.7778 votes (subject to adjustment) with
respect to any and all matters presented to the Companys stockholders for their action or
consideration. Except as provided by law or by the provisions establishing any other series
of preferred stock, holders of Series D Convertible Preferred Stock and holders of any other
outstanding preferred stock shall vote together with the holders of common stock as a single
class.
Series E Convertible Preferred Stock On December 13, 2005, the Company filed a
Certificate of Designation with the Secretary of State of the State of Delaware designating
167,000 shares of the Companys 5,000,000 authorized shares of preferred stock as Series E
Convertible Preferred Stock, $0.01 par value, with a stated value of $25.00 per share.
Dividends accrue at a rate of 6.0% per annum on the $25.00 stated value per share and are
payable semi-annually on April 15 and October 15 of each year while the shares are
outstanding. The Company has the option to pay the dividend either in cash or in equivalent
shares of common stock, as defined. Included in the carrying value of the Series E
Convertible Preferred Stock in the accompanying consolidated balance
- 14 -
sheets are $67,886 and
$68,107 of accrued preferred stock dividends as of September 30, 2008 and March 31, 2008,
respectively. Each share of Series E Convertible Preferred Stock may be converted by the holder at any time into shares of common
stock at a conversion rate determined by dividing the $25.00 stated value, plus any accrued
and unpaid dividends (the Liquidation Price E), by a $7.04 conversion price (the
Conversion Price E), subject to certain adjustments, as defined in the Series E
Certificate of Designation. On April 15, 2007, the Company issued 12,531 shares of common
stock and paid $132 in lieu of fractional common shares as dividends on the preferred
shares. On April 15, 2008, the Company issued 79,532 shares of common stock and paid $13 in
lieu of fractional common shares as dividends on the preferred shares. During the three and
six month periods ended September 30, 2007, certain preferred stockholders converted 1,600
and 3,600 shares of Series E Convertible Preferred Stock, including accrued dividends, for
5,813 and 12,972 shares of common stock, respectively. During the three month period ended
September 30, 2008 there were no conversions. During the six month period ended September
30, 2008, a preferred stockholder converted 800 shares of Series E Convertible Preferred
Stock, including accrued dividends, for 3,035 shares of common stock.
The Company may at any time, require that any or all outstanding shares of Series E
Convertible Preferred Stock be converted into shares of our common stock, provided that the
shares of common stock into which the Series E Convertible Preferred Stock are convertible
are registered pursuant to an effective registration statement, as defined. The number of
shares of common stock to be received by the holders of the Series E Convertible Preferred
Stock upon a mandatory conversion by us is determined by (i) dividing the Liquidation Price
E by the Conversion Price E provided that the closing bid price for the Companys common
stock exceeds $10.56 for 20 out of 30 consecutive trading days within 180 days prior to
notice of conversion, as defined, or (ii) if the requirements of (i) are not met, the number
of shares of common stock is determined by dividing 110% of the Liquidation Price E by the
Conversion Price E. The Conversion Price E is subject to certain adjustments, as defined in
the Certificate of Designation.
The Series E Convertible Preferred Stock has a preference in liquidation equal to $25.00 per
share, plus any accrued and unpaid dividends, over the common stock and is pari passu with
all other outstanding series of preferred stock. Each issued and outstanding share of
Series E Convertible Preferred Stock is entitled to 3.5511 votes (subject to adjustment)
with respect to any and all matters presented to the Companys stockholders for their action
or consideration. Except as provided by law or by the provisions establishing any other
series of preferred stock, holders of Series E Convertible
Preferred Stock and holders of any
other outstanding preferred stock shall vote together with the holders of common stock as a
single class.
The Company will, on December 13, 2008, at the Companys election, (i) redeem the Series E
Convertible Preferred Stock plus any accrued and unpaid interest for cash, (ii) convert the
Series E Convertible Preferred Stock and any accrued and unpaid interest into common stock,
or (iii) redeem and convert the Series E Convertible Preferred Stock in any combination of
(i) or (ii).
- 15 -
Common Stock No common stock other than through the exercise of options, dividends on
preferred shares or conversion of preferred shares was issued in the three and six month
periods ended September 30, 2007 and 2008.
Warrants During the three and six month periods ended September 30, 2007, warrants to
purchase 48,312 shares of common stock were exercised, resulting in proceeds to the Company
of $295,737. During the three and six month periods ended September 30, 2008, no warrants
were exercised.
In connection with services rendered to us, effective July 17, 2007, the Company issued to
an investor relations firm, warrants to purchase 30,000 shares of our common stock. The
warrants are exercisable at $9.00 per share. The warrants are exercisable through July 17,
2011 as follows: (i) 10,000 vest immediately, (ii) 10,000 vest upon the Companys stock
trading at or above $10.00 per share for 20 consecutive trading days and (iii) 10,000 vest
upon the Companys stock trading at or above $12.00 per share for 20 consecutive trading
days. The warrants have been expensed using a grant date value as calculated using the
Black-Scholes valuation model of approximately $118,000.
In connection with a consulting agreement, the Company issued warrants on September 10, 2007
to purchase 50,000 shares of common stock. The warrants are exercisable at $10.00 per
share. The warrants are exercisable through September 10, 2010. The warrants have been
expensed using a grant date value as calculated using the Black-Scholes valuation model of
approximately $172,000.
Incentive Stock Programs At the stockholders meeting held November 12, 2004, the
stockholders approved the second amendment to the 2000 Stock Incentive Plan which increased
the number of shares of common stock reserved for issuance from 1,100,000 shares to
2,200,000 shares. At the stockholders meeting held November 29, 2007, the stockholders
approved the 2007 Stock Incentive Plan which increased the number of shares of common stock
reserved for issuance an additional 1,500,000 shares. Options granted under the 2000 and
2007 Stock Incentive Plans that expire are available to be reissued. During the six month
periods ended September 30, 2007 and 2008, 81,000 and 124,000 options, respectively,
previously granted under the 2000 and 2007 Stock Incentive Plans expired and were available
to be reissued. During the three month period ended September 30, 2007, the Company issued
167,168 options to purchase shares of common stock. During the six month periods ended
September 30, 2007, the Company issued 174,668 options to purchase shares of common stock.
During the three and six month periods ended September 30, 2008, no options were issued. As
of September 30, 2008, there were a total of 1,717,274 shares available for grant. The
purchase price of shares must be at least equal to the fair market value of the common stock
on the date of grant, and the maximum term of an option is 10 years. The options generally
vest over periods ranging from 0 to 3 years.
- 16 -
The Company recognized approximately $611,000 and $1,104,000 of compensation cost for the
three and six month periods ended September 30, 2007, and approximately $285,000 and
$604,000 for the three and six month periods ended September 30, 2008. The compensation
cost for the six month period ended September 30, 2008 was offset by
a credit of approximately $609,000 due to the change in forfeiture rate reported in the
prior Form 10-Q. During the three and six month periods ended September 30, 2007, 19,119
options were exercised on a cashless basis resulting in 18,000 common shares being issued
with an exercise price of $0.46. During the six month period ended September 30, 2008,
11,387 options were exercised on a cashless basis resulting in 4,931 common shares being
issued with an exercise price of $0.46.
The fair value of each stock option award is estimated on the date of grant using the
Black-Scholes valuation model. The Company uses historical data regarding stock option
exercise behaviors to estimate the expected term of options granted (based on the period of
time that options granted are expected to be outstanding). Expected implied volatility is
based on the volatility of the Companys exchange traded options for the Companys common
stock. The risk-free interest rate is based on the U.S. treasury security rate in effect
over the estimated life of the option. There is no dividend yield. The following
weighted-average assumptions were used in calculating the fair value of stock options
granted during the three and six month periods ended September 30, 2008 and 2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
Six Months |
|
|
Ended |
|
Ended |
|
|
September 30, |
|
September 30, |
|
|
2007 |
|
2008 |
|
2007 |
|
2008 |
|
Risk free interest rate |
|
|
4.67 |
% |
|
|
0 |
% |
|
|
4.69 |
% |
|
|
0 |
% |
Average life of options (years) |
|
|
10.0 |
|
|
|
0 |
|
|
|
10.0 |
|
|
|
0 |
|
Volatility |
|
|
77 |
% |
|
|
0 |
% |
|
|
76 |
% |
|
|
0 |
% |
Dividend yield |
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
A summary of stock option activity as of and for the six month period ended September 30,
2008, is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
|
|
|
|
|
|
|
|
Contractual |
|
|
|
|
|
|
Exercise Price |
|
Term(*) in |
|
|
Shares |
|
Per Share (*) |
|
Years |
Outstanding at March 31, 2008 |
|
|
2,098,113 |
|
|
$ |
8.53 |
|
|
|
|
|
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(11,387 |
) |
|
|
.46 |
|
|
|
|
|
Forfeited or expired |
|
|
(179,490 |
) |
|
|
7.54 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2008 |
|
|
1,907,236 |
|
|
|
8.67 |
|
|
|
6.61 |
|
|
|
|
|
|
|
|
|
|
Exercisable at September 30, 2008 |
|
|
1,694,031 |
|
|
|
8.95 |
|
|
|
6.34 |
|
|
|
|
|
|
|
|
|
|
|
The weighted-average grant date fair value of options granted during the six month periods
ended September 30, 2007 and 2008 was $6.94 and $0, respectively. The intrinsic value of
options exercised during the six month periods ended September 30, 2007 and 2008 was
approximately $143,000 and $7,000, respectively. The intrinsic value of stock options
outstanding at the six month periods ended September 30, 2007 and 2008 was approximately
$2,921,000 and $0, respectively.
- 17 -
As of September 30, 2008, there was approximately $673,000 of unrecognized compensation cost
related to non-vested stock option compensation arrangements granted under the 2000 and 2007
Plans that is expected to be recognized as a charge to earnings over a weighted-average
period of 0.6 years. As of September 30, 2008, 1,694,028 options have vested or are
expected to vest with a weighted-average exercise price of $6.46, a weighted-average
remaining life of 6.62 years, and with an intrinsic value of approximately $0.
4. |
|
COLLABORATIVE RESEARCH AND DEVELOPMENT ACTIVITIES |
The Company earns revenue under various collaborative research agreements. Under the terms
of these arrangements, the Company generally has agreed to perform best efforts research and
development and, in exchange, the Company may receive advanced cash funding, an allowance
for management overhead, and may also earn additional fees for the attainment of certain
milestones.
The Company initially acquired its rights to the aromatic cation technology platform
developed by a consortium of universities consisting of UNC-CH, Georgia State University,
Duke University and Auburn University pursuant to an agreement, dated January 15, 1997 (as
amended, the Consortium Agreement) among the Company, UNC-CH and a third-party (to which
each of the other members of the scientific consortium shortly thereafter joined) (the
original licensee). The Consortium Agreement commits the parties to collectively
research, develop, finance the research and development of, manufacture and market both the
technology and compounds owned by the scientific consortium and previously licensed or
optioned to the original licensee and licensed to the Company in accordance with the
Consortium Agreement (the Current Compounds), and all technology and compounds developed
by the scientific consortium after January 15, 1997, through use of Company-sponsored
research funding or National Cooperative Drug Development grant funding made available to
the scientific consortium (the Future Compounds and, collectively with the Current
Compounds, the Compounds).
The Consortium Agreement contemplated that upon the completion of our initial public
offering (IPO) of shares of its common stock with gross proceeds of at least $10,000,000
by April 30, 1999, the Company, with respect to the Current Compounds, and UNC-CH, (on
behalf of the Scientific Consortium), with respect to Compounds, would enter into license
agreements for the intellectual property rights relating to the Compounds pursuant to which
the Company would pay royalties and other payments based on revenues received for the sale
of products based on the Compounds.
The Company completed an IPO on April 26, 1999, with gross proceeds in excess of $10,000,000
thereby earning a worldwide license and exclusive rights to commercially use, manufacture,
have manufactured, promote, sell, distribute, or otherwise dispose of any products based
directly or indirectly on all of the Compounds.
- 18 -
As a result of the closing of the IPO, the Company issued an aggregate of 611,250 shares of
common stock, of which 162,500 shares were issued to the Scientific Consortium and
448,750 shares were issued to the original licensee or persons designated by the original
licensee.
As contemplated by the Consortium Agreement, on January 28, 2002, the Company entered into a
license agreement with the Scientific Consortium whereby the Company received the exclusive
license to commercialize the aromatic cation technology platform and compounds developed or
invented by one or more of the Consortium scientists after January 15, 1997 (the License
Agreement), and which also incorporated into such License Agreement the Companys existing
license with the Scientific Consortium with regard to the Current Compounds. Also pursuant
to the Consortium Agreement, the original licensee transferred to the Company the worldwide
license and exclusive right to commercially use, manufacture, have manufactured, promote,
sell, distribute or otherwise dispose of any and all products based directly or indirectly
on aromatic cations developed by the Scientific Consortium on or prior to January 15, 1997
and previously licensed (together with related technology and patents) to the third-party.
The Consortium Agreement provides that the Company is required to pay to UNC-CH on behalf of
the Scientific Consortium reimbursement of patent and patent-related fees, certain milestone
payments and royalty payments based on revenue derived from the Scientific Consortiums
aromatic cation technology platform. Each month on behalf of the inventor scientist or
university, as the case may be, UNC-CH submits an invoice to the Company for payment of
patent-related fees related to Compounds incurred prior to the invoice date. The Company is
also required to make milestone payments in the form of the issuance of 100,000 shares of
its common stock to the Scientific Consortium when it files its first initial New Drug
Application (NDA) or an Abbreviated New Drug Application (ANDA) based on Scientific
Consortium technology. The Company is also required to pay to UNC-CH on behalf of the
Scientific Consortium (other than Duke University) (i) royalty payments of up to 5% of our
net worldwide sales of current products and future products (products based directly or
indirectly on Current Compounds and Future Compounds, respectively) and (ii) a percentage of
any fees the Company receives under sublicensing arrangements. With respect to products or
licensing arrangements emanating from Duke University technology, the Company is required to
negotiate in good faith with UNC-CH (on behalf of Duke University) royalty, milestone or
other fees at the time of such event, consistent with the terms of the Consortium Agreement.
Under the License Agreement, the Company must also reimburse the cost of obtaining patents
and assume liability for future costs to maintain and defend patents so long as the Company
chooses to retain the license to such patents.
During the three and six month periods ended September 30, 2008, the Company expensed
approximately $62,000 and $167,000, respectively, of other payments to UNC-CH and certain
other Scientific Consortium universities for patent related costs and other contracted
research. For the corresponding periods ended September 30, 2007, the Company expensed
approximately $212,000 and $404,000, respectively. Included in accounts payable as of
September 30, 2008 and March 31, 2008, were approximately
$238,000, and $775,000, respectively, due to UNC-CH and certain other Scientific Consortium
universities.
- 19 -
In November 2000, The Bill & Melinda Gates Foundation (Foundation) awarded a $15,114,000
grant to UNC-CH (the Foundation Grant) to develop new drugs to treat human Trypanosomiasis
(African sleeping sickness) and leishmaniasis. On March 29, 2001, UNC-CH entered into a
clinical research subcontract agreement with the Company, whereby the Company was to receive
up to $9,800,000, subject to certain terms and conditions, over a five year period to
conduct certain clinical and research studies related to the Foundation Grant.
In April 2003, the Foundation awarded a supplemental grant of approximately $2,700,000 to
UNC-CH for the expansion of phase IIB/III clinical trials to treat human Trypanosomiasis
(African sleeping sickness) and improved manufacturing processes. The Company has received,
pursuant to the clinical research subcontract with UNC-CH, inclusive of its portion of the
supplemental grant, a total amount of funding of approximately $11,700,000. Grant funds
paid in advance of the Companys delivery of services are treated as restricted funds and
must be segregated from other funds and used for the purposes specified. In March 2006, the
Company amended and restated the clinical research subcontract with UNC-CH, and UNC-CH in
turn obtained an expanded funding commitment for the Company of approximately $13,601,000
from the Foundation. Under the amended and restated agreement, the Company received on May
24, 2006 the first payment of approximately $5,649,000 of the five year approximately
$13,601,000 contract.
During the three and six months ended September 30, 2008, approximately $487,000 and
$1,512,000 was utilized for clinical and research purposes conducted and expensed,
respectively. During the three and six months ended September 30, 2007, approximately
$626,000 and $1,304,000 was utilized for clinical and research purposes conducted and
expensed, respectively. The Company has recognized revenues of approximately $487,000 and
$1,512,000 during the three and six months ended September 30, 2008, respectively. The
Company has recognized revenues of approximately $626,000 and $1,304,000 during the three
and six months ended September 30, 2007, respectively. The remaining amount (approximately
$736,000 as of September 30, 2008) has been deferred and will be recognized as revenue over
the term of the agreement as the services are performed.
On June 8, 2007, the Company entered into an exclusive licensing agreement pursuant to which
the Company licensed to Par Pharmaceutical Companies, Inc. (Par) commercialization rights
in the U.S. to pafuramidine for the treatment of pneumocystis pneumonia (PCP) in AIDS
patients (Par License Agreement). Under the Par License Agreement, the Company and Par
also contemplated collaborating on efforts to develop pafuramidine as a preventative therapy
for patients at risk of developing PCP, including people living with HIV, cancer and other
immunosuppressive conditions.
- 20 -
In return, the Company received an initial payment of $3 million. Par was to also pay the
Company as much as $29 million in development milestones if pafuramidine advanced
through ongoing Phase III clinical trials and the United States Food and Drug Administration
(FDA) regulatory review and approval. In addition to royalties on sales, the Company
could have received up to $115 million in additional milestone payments on future sales and
retain the right to co-market pafuramidine in the U.S. The Company granted Par a right of
first offer to enter into a license agreement with it if the Company determined that
pafuramidine could be used for the treatment and/or prophylaxis of malaria. As a result of
the discontinuation of the pafuramidine program, the Company recognized approximately
$10,000 and $68,000 of deferred income in the three and six month periods ended September
30, 2008, respectively. The Par License Agreement was terminated by Par on May 9, 2008.
On December 3, 2007, the Company entered into a licensing agreement with BioAlliance Pharma
SA (BioAlliance) pursuant to which the Company granted Bio-Alliance and its affiliates an
exclusive license to commercialize pafuramidine in Europe for the treatment of PCP in AIDS
patients and African sleeping sickness (BioAlliance License Agreement). The Company also
granted BioAlliance an option to commercialize pafuramidine in Europe for the prevention and
treatment of malaria in travelers. Pursuant to the BioAlliance License Agreement, the
Company received an initial payment of $3 million from BioAlliance, and it was to have
received an additional $13 million upon achieving certain regulatory and pricing milestones.
In addition, the Company was to have received an additional $10 million upon achieving
certain sales milestones and was to have received double-digit royalties based on sales. As
a result of the discontinuation of the pafuramidine program, the Company recognized
approximately $9,000 and $67,000 of deferred income in the three and six month periods ended
September 30, 2008.
On December 20, 2007, the FDA informed the Company that it had placed all of the Companys
ongoing and projected clinical trials relating to the development of pafuramidine on
clinical hold. Subsequently the program was discontinued on February 22, 2008.
In October 2003, Gerhard Von der Ruhr and his son Mark (the Von der Ruhr Plaintiffs) filed
a complaint in the United States District Court for the Northern District of Illinois
against the Company and certain officers and directors alleging breaches of a stock lock-up
agreement, option agreements and a technology license agreement by the Company. The Von de
Ruhr Plaintiffs also alleged a claim for intentional interference with contractual relations
by certain officers of the Company. The complaint sought unspecified monetary damages and
punitive damages, in addition to equitable relief and costs. In a filing made in late
February 2005, the Von der Ruhr Plaintiffs specified damages of approximately $44.5 million
in damages.
- 21 -
In 2005, one of the breach of contract claims was dismissed upon the Companys motion for
summary judgment. On October 26, 2006, a preliminary pre-trial conference was held and the
court granted the Companys motions in limine to exclude plaintiffs damage claim for lost
profits and prohibited plaintiff from offering expert testimony at trial on this issue. The
court subsequently granted a motion to sever the trial on Count V,
regarding the technology license agreement, from the trial on the remaining counts. The
trial on the remaining counts concluded on December 7, 2007, and a jury returned a verdict
against the Company and certain officers and directors for a total amount of $361,704.90.
The Company immediately filed a motion with the court seeking to overturn the jury verdict,
which the court subsequently denied.
In the first quarter of 2008, the Von der Ruhr Plaintiffs appealed the trial courts ruling
excluding their damage claim for lost profits. Separately, the Companys officers and
directors have appealed the jurys finding on the intentional interference with contractual
relations claim. The United States Court of Appeals for the Seventh Circuit has
consolidated these appeals, and briefing to the appellate court was completed on October 17,
2008. The appeals are now pending decision before the appellate court.
6. SUBSEQUENT EVENT
Subsequent to September 30, 2008, the Company engaged a sales agent for marketing the land
use rights in Shenzhen, China.
* * * * * *
- 22 -
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Item 2. |
|
Managements Discussion and Analysis of Financial Condition and Results
of Operations. |
Forward Looking Statements
Certain statements contained in this quarterly report and in the documents incorporated by
reference herein constitute forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements other than statements of historical fact
may be deemed to be forward-looking statements. Forward-looking statements frequently, but not
always, use the words may, intends, plans, believes, anticipates or expects or similar
words and may include statements concerning our strategies, goals and plans. Forward-looking
statements involve a number of significant risks and uncertainties that could cause our actual
results or achievements or other events to differ materially from those reflected in such
forward-looking statements. Such factors include, among others described in this quarterly report,
the following: (i) we are in an early stage of product development, (ii) the possibility that
favorable relationships with collaborators cannot be established or, if established, will be
abandoned by the collaborators before completion of product development, (iii) the possibility that
we or our collaborators will not successfully develop any marketable products, (iv) the possibility
that advances by competitors will cause our product candidates not to be viable, (v) uncertainties
as to the requirement that a drug product be found to be safe and effective after extensive
clinical trials and the possibility that the results of such trials, if completed, will not
establish the safety or efficacy of our drug product candidates, (vi) risks relating to
requirements for approvals by governmental agencies, such as the Food and Drug Administration,
before products can be marketed and the possibility that such approvals will not be obtained in a
timely manner or at all or will be conditioned in a manner that would impair our ability to market
our product candidates successfully, (vii) the risk that our patents could be invalidated or
narrowed in scope by judicial actions or that our technology could infringe upon the patent or
other intellectual property rights of third parties, (viii) the possibility that we will not be
able to raise adequate capital to fund our operations through the process of commercializing a
successful product or that future financing will be completed on unfavorable terms, (ix) the
possibility that any products successfully developed by us will not achieve market acceptance and
(x) other risks and uncertainties that may not be described herein. We undertake no obligation to
update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Results of Operations
With the exception of certain research funding agreements, license agreements and certain grants,
we have not generated any revenue from operations. For the period from inception (October 15,
1984) to September 30, 2008, we incurred cumulative net losses of approximately $110,289,000. We
have incurred additional losses since such date and we expect to incur additional operating losses
for the foreseeable future. We expect that our cash sources for at least the next year will be
limited to:
|
|
|
payments from foundations and other collaborators under arrangements that may be
entered into in the future; |
- 23 -
|
|
|
payments from license agreement milestones; |
|
|
|
grants from the United States government and other governments and entities; and |
|
|
|
the issuance
of securities or borrowing of funds or sale of the land use rights in
Shenzhen, China. |
The timing and amounts of grant and payment revenues, if any, will likely fluctuate sharply and
depend upon the achievement of specified milestones, and results of operations for any period may
be unrelated to the results of operations for any other period.
Three Month Period Ended September 30, 2008 Compared with the Three Month Period Ended September
30, 2007.
Revenues under collaborative research and development, and license agreements were approximately
$506,000 and $1,030,000 for the three month periods ended September 30, 2008 and September 30,
2007, respectively. For the three month period ended September 30, 2008, we recognized revenues of
approximately $487,000 related to a clinical research subcontract agreement between us and UNC-CH
and approximately $10,000 related to the Par License Agreement which has been cancelled and $9,000
related to the BioAlliance License Agreement, while for the three month period ended September 30,
2007, revenues recognized of approximately $626,000 related to the abovementioned UNC-CH clinical
research subcontract, and approximately $404,000 related to the Par License Agreement.
Grant and research and development agreement revenue is recognized as completed under the terms of
the respective agreements, according to Company estimates. Grant and research and development
funds received prior to completion under the terms of the respective agreements are recorded as
deferred revenues.
Revenue from licensing arrangements is recorded when earned based on the performance requirements
of the contract. Nonrefundable upfront license fees, for product candidates where the Company is
providing continuing services related to product development, are deferred and recognized as
revenue over the development period or as the Company provides services required under the
agreement. The timing and amount of revenue the Company recognizes from licenses, either from
upfront fees or milestones where the Company is providing continuing services related to product
development, is dependent upon the Companys estimates of filing dates.
Research and development expenses decreased to approximately $990,000 from $2,283,000 for the three
month periods ended September 30, 2008 and September 30, 2007, respectively. Expenses relating to
the UNC-CH subcontract, decreased to approximately $487,000 in the three month period ended
September 30, 2008 from approximately $626,000 in the three month period ended September 30, 2007.
Expenses associated with setting up operations in mainland China were approximately $105,000 for
the three month period ended September 30, 2008. Contract services relating to clinical trials and
their discontinuation decreased to approximately $190,000 in the three month period ended September
30, 2008 from approximately $1,120,000 in the three month period ended September 30, 2007.
Discovery contract research expenses decreased to approximately $140,000 in the three month period
ended September 30, 2008 from
approximately $408,000 in the three month period ended September 30, 2007. Non-cash options
expense under research and development decreased to approximately $66,000 in the three month period
ended September 30, 2008 from approximately $115,000 in the three month period ended September 30,
2007. Other research and development expenses decreased approximately $7,000 in the three month
period ended September 30, 2008 from the three month period ended September 30, 2007.
- 24 -
General and administrative expenses decreased to approximately $1,268,000 from approximately
$2,214,000 during the three month periods ended September 30, 2008, and September 30, 2007,
respectively. Patent fees decreased to approximately $61,000 in the three month period ended
September 30, 2008 from approximately $101,000 in the three month period ended September 30, 2007.
Operating expenses in Immtech Hong Kong increased to approximately $82,000 from approximately
$36,000 in the three month periods ended September 30, 2008 and September 30, 2007, respectively.
Payroll and payroll related costs decreased to approximately $300,000 from approximately $338,000
over the same periods. Additionally, public relation costs decreased to approximately $35,000 in
the three month period ended September 30, 2008 from approximately $188,000 in the three month
period ended September 30, 2007. Non-cash general and administrative expenses decreased to
approximately $219,000 in the three month period ended September 30, 2008 for the expensing of
options, from approximately $786,000 in the three month period ended September 30, 2007 which
includes (i) approximately $172,000 for 50,000 warrants issued to a consultant, (ii) approximately
$118,000 for 30,000 warrants issued to an investor relations firm, and (iii) approximately $496,000
for expensing options. All other general and administrative expenses decreased approximately
$446,000 over the same periods, primarily due to increased cost controls.
During the three month period ended
September 30, 2008, the Company recorded a non-cash asset impairment
charge of approximately $693,000.
Our net loss decreased to approximately $2,435,000 from approximately $3,334,000 during the three
month periods ended September 30, 2008 and September 30, 2007, respectively.
Six Month Period Ended September 30, 2008 Compared with the Six Month Period Ended September 30,
2007.
Revenues under collaborative research and development agreements were approximately $1,647,000 and
$1,857,000 for the six month periods ended September 30, 2008 and September 30, 2007, respectively.
For the six month period ended September 30, 2008, we recognized revenues of approximately
$1,513,000 related to a clinical research subcontract agreement between us and UNC-CH,
approximately $67,000 related to the Par License Agreement, and approximately $67,000 related to
the BioAlliance License Agreement, while for the six month period ended September 30, 2007,
revenues recognized of approximately $1,304,000 related to the abovementioned UNC-CH clinical
research subcontract and $553,000 related to the Par License Agreement.
Grant and research and development agreement revenue is recognized as completed under the terms of
the respective agreements, according to Company estimates. Grant and research and development
funds received prior to completion under the terms of the respective agreements are recorded as
deferred revenues.
- 25 -
Revenue from licensing arrangements is recorded when earned based on the performance requirements
of the contract. Nonrefundable upfront license fees, for product candidates where the Company is
providing continuing services related to product development, are deferred and recognized as
revenue over the development period or as the Company provides services required under the
agreement. The timing and amount of revenue the Company recognizes from licenses, either from
upfront fees or milestones where the Company is providing continuing services related to product
development, is dependent upon the Companys estimates of filing dates.
Research and development expenses decreased to approximately $2,485,000 from $4,201,000 for the six
month periods ended September 30, 2008 and September 30, 2007, respectively. Expenses relating to
the UNC-CH subcontract, increased to approximately $1,513,000 in the six month period ended
September 30, 2008 from approximately $1,221,000 in the three month period ended September 30,
2007. Additionally, contract services relating to trials for treatment of PCP and the subsequent
termination decreased to approximately $211,000 from approximately $2,016,000 in the same periods.
Discovery contract research expenses decreased to approximately $407,000 in the six month period
ended September 30, 2008 from approximately $606,000 in the period ended September 30, 2007.
Expenses associated with setting up operations in mainland China were approximately $166,000 for
the six month period ended September 30, 2008. Non-cash options expense under research and
development decreased to approximately $161,000 in the six month period ended September 30, 2008
from approximately $233,000 in the six month period ended September 30, 2007. Other research and
development expenses decreased approximately $8,000 from the six month period ended September 30,
2007 to the six month period ended September 30, 2008.
General and administrative expenses decreased to approximately $2,193,000 from approximately
$3,931,000 during the six month periods ended September 30, 2008, and September 30, 2007,
respectively. Legal fees decreased to approximately $232,000 in the six month period ended
September 30, 2008 from approximately $333,000 in the six month period ended September 30, 2007.
Contact services, including public relations, decreased to approximately $132,000 from
approximately $483,000 during the same periods. Operating expenses in Immtech Hong Kong increased
to approximately $126,000 from approximately $71,000 in the six month periods ended September 30,
2008 and September 30, 2007, respectively. Non-cash general and administrative expenses decreased
to approximately $15,000 in the six month period ended September 30, 2008, having benefited by a
reversal of approximately $428,000 due to the change in the option forfeiture rate under SFAS No.
123(R) upon the reduction in personnel in the first quarter of the fiscal year, from approximately
$1,161,000 in the six month period ended September 30, 2007, which includes (i) approximately
$172,000 for the 50,000 warrants issued to a consultant, (ii) approximately $118,000 for the 30,000
warrants issued to an investor relations firm, and (iii) approximately $871,000 for expensing
options. Other general and administrative expenses decreased approximately $195,000 over the same
periods.
During the six month period ended
September 30, 2008, the Company recorded a non-cash asset impairment
charge of approximately $693,000.
Our net loss decreased to approximately $3,692,000 from approximately $5,995,000 during the six
month periods ended September 30, 2008 and September 30, 2007, respectively.
Business
Plans
AQ-13
and Other Infectious Diseases
Our clinical and regulatory staff is planning for the clinical development of AQ-13 for the
treatment of malaria and malaria prophylaxis in travelers. We have identified and are preparing to
execute additional toxicology and genotoxicology studies, and planning the Phase I dose ranging
study of AQ-13. We recently received an Orphan Drug Designation for AQ-13 in treatment of malaria,
and have licensed exclusive rights to AQ-13 and other 4-aminoquinolines in development from Tulane
University. We are currently pursuing relationships with NGOs and foundations to provide support
for the development of AQ-13. We do not believe that we will not develop this program unless we
obtain third party funding to cover or reduce third party and overhead expenses, and the resultant
burn rate. We expect to initiate the AQ-13 program in the first half of calendar year 2009.
We are also currently in discussions with commercial pharmaceutical organizations and NGOs
regarding providing services related to the clinical development of proprietary compounds for
infectious diseases on a fee-for-services basis. We believe that such arrangements will result in
positive cash flow and help to reduce overall ongoing operational expenses.
Discovery Programs
We are actively working on the following long term discovery programs currently supported by
Company funds:
Hepatitis C Virus (HCV): Through a combination of academic collaboration and contract services,
we are advancing an HCV drug discovery effort. In June 2008, we announced that a prototype
compound belonging to this expanding class of compounds was found to have activity against HCV
under assay conditions designed to demonstrate inhibition of the virus entry process. We are
currently engaged in new medicinal chemistry and screening efforts to optimize the lead for potency
and oral availability.
West Nile and Dengue Fever: Our understanding of mechanism of action of these compounds has led us
to investigate the application of our technology to inhibit the virus entry process of other
therapeutically important virus targets in the flavivirus family. Two notables in this family are
West Nile virus (WNV) and Dengue Fever virus. Screening efforts for WNV in particular have
caused us to identify a promising lead series which is currently undergoing lead optimization
through new medicinal chemistry.
The following programs are only being moved forward if third party funding is obtained:
Antifungal and Antibiotic: We are currently evaluating potential partnership opportunities for our
antifungal and antibiotic discovery programs. We have initiated discussions with potential
collaborators who may be interested in funding and executing additional discovery efforts in
exchange for future royalties or licensing rights.
China
Early this year, we announced the initiation of a collaboration with Beijing Capital Medical
University (BCMU) in Beijing, one of Chinas leading academic medical research centers. The
Company and BCMU are considering the development of a joint venture to provide contract research
services (CRS) in China. With an initial focus on early-stage drug discovery, we believe that a
joint venture could be positioned to support later-stage clinical development including
coordination with research sites, data management, monitoring and reporting for clinical research
programs. We also plan to explore the potential of having joint ventures with Chinese
pharmaceutical companies that are interested in expanding outside of China. These companies could
provide funding and resources to further develop our compounds.
Additionally, we believe that our
experience in and knowledge of the Chinese market may also permit us to explore other business
development opportunities in China.
- 26 -
Liquidity and Capital Resources
The accompanying 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.
Since inception, the Company has incurred accumulated net losses of approximately $110,289,000.
Management expects the Company will continue to incur significant losses during the next several
years as the Company continues development activities, clinical trials and commercialization
efforts. In addition, the Company has various research and development agreements with third
parties and is dependent upon such parties abilities to perform under these agreements. There can
be no assurance that the Companys activities will lead to the development of commercially viable
products. The Companys operations to date have consumed substantial amounts of cash. The
negative cash flow from operations is expected to continue in the foreseeable future. The Company
believes it will require substantial additional funds to commercialize its drug candidates. The
Companys cash requirements may vary materially from those now planned when and if the following
become known: formation and development of relationships with strategic partners, changes in the
focus and direction of development programs, results of research and development efforts, results
of clinical testing, responses to grant requests, competitive and technological advances,
requirements in the regulatory process and other factors. Changes in circumstances in any results
of our new global business initiatives may require the Company to allocate substantially more funds
than are currently available or than management intends to raise.
As of September 30, 2008, cash and cash equivalents were approximately $2,077,000.
We spent approximately $1,000 and $4,000, respectively, on equipment purchases during the three and
six month periods ended September 30, 2008. Nothing was spent on equipment purchases during the
six month period ended September 30, 2007. No significant purchases of equipment are anticipated
by us during the year ending March 31, 2009.
We periodically receive cash from the exercise of common stock options and warrants. No options or
warrants were exercised for cash during the three or six month periods ended September 30, 2008.
During the three and six month periods ended September 30, 2007, we received approximately $296,000
from the exercise of warrants.
Through September 30, 2008, we financed our operations with:
|
|
|
proceeds from various private placements of debt and equity securities, secondary
public stock offerings, our initial public offering (our IPO), and other cash
contributed from stockholders, which in the aggregate raised approximately $77,608,000; |
|
|
|
payments from research agreements, licensing agreements, foundation grants, and
Small Business Innovation Research (SBIR) grants and Small Business Technology
Transfer program grants of approximately $36,447,000; and |
|
|
|
the use of stock, options and warrants in lieu of cash compensation. |
Our cash resources have been used to finance, develop and begin commercialization of drug product
candidates, including sponsored research, conducting human clinical trials, capital expenditures,
expenses associated with development of product candidates pursuant to the Consortium Agreement,
and, as contemplated by the Consortium Agreement, under the License Agreement with the Scientific
Consortium, and general and administrative expenses. Over the next several years we expect to
incur substantial additional research and development costs, including costs related to research in
pre-clinical (laboratory) and human clinical trials, administrative expenses to support our
research and development operations and marketing expenses to launch the sale of any commercialized
product that may be developed.
Our future working capital requirements will depend upon numerous factors, including the progress
of research, development and commercialization programs (which may vary as product candidates are
added or abandoned), results of pre-clinical testing and human clinical trials, achievement of
regulatory milestones, third party collaborators fulfilling their obligations to us, the timing and
cost of seeking regulatory approvals, the level of resources that we devote to the engagement or
development of manufacturing capabilities, our ability to maintain existing and to establish new
collaborative arrangements with others to provide funding to support these activities, and other
factors. In any event, we will require substantial additional funds in addition to our existing
resources to develop product candidates and to otherwise meet our business objectives.
- 27 -
We believe our existing unrestricted cash and cash equivalents and the grants we have received or
have been awarded and are awaiting disbursement of, will be sufficient to meet our planned
expenditures through at least January 2009, although there can be no assurance we will not require
additional funds.
As of November 1, 2008, the Company has the following cash:
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|
Unrestricted cash and cash equivalents |
|
$ |
1,776,058 |
|
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Restricted funds on deposit |
|
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915,437 |
|
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$ |
2,691,495 |
|
Based on forecasted monthly usage of unrestricted cash of approximately $450,000 and after
consideration of payment of liabilities recorded as of November 1, 2008, we believe funding is
available to continue operations through January 31, 2009. In order to maintain operations and
liquidity after that date, the following options are being pursued and are discussed below:
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sale of land use rights in
Shenzhen, China; |
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|
discussions with commercial
pharmaceutical organizations and NGOs for providing development services for compounds slated for
clinical development on a fee-for-services basis; and |
|
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|
restrictions on staffing based on businesses to be developed and pursued. |
Subsequent to September 30, 2008, the Company engaged a sales agent for the sale of the land use
rights in Shenzhen, China. We believe that the proceeds from the sale of the land use rights will provide
cash to fund operations through June 30, 2009. As noted in Note 2 (Long-Lived
Assets), the Company has recorded an asset impairment charge of $693,073 in
the second quarter of fiscal year 2009. However, due to the current uncertainty in the
market, there can be no assurance that the Company will be able to realize its full carrying value.
In the event the aforementioned options
are unsuccessful, the Company may be unable to sustain its operations beyond
January 31, 2009 due to a lack of cash resources. However, in the
meantime, the Company will explore all options including fund raising, joint
ventures, licensing, reducing expenses, and will consider all possibilities
including merger with another company, selling the Company, ceasing operations
or seeking protection under applicable laws.
Managements plans for the remainder of the fiscal year, in addition to normal operations, include
continuing their efforts to create joint ventures, obtain additional grants and to develop and
enter into research, development and/or commercialization agreements with others.
- 28 -
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Item 3. |
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Quantitative and Qualitative Disclosures about Market Risk. |
The exposure of market risk associated with risk-sensitive instruments is not material, as our
operations are conducted primarily in U.S. dollars and we invest primarily in short-term government
obligations and other cash equivalents. We intend to develop policies and procedures to manage
market risk in the future if and when circumstances require. We have no off-balance sheet
arrangements as defined in Regulation S-K Item 303(a)(4)(ii).
The volatility and disruption of the capital and credit markets and adverse changes in the global
economy may negatively impact our business. Due to the existing uncertainty in the capital and
credit markets, our access to capital may not be available on terms acceptable to Immtech or at
all. Further, if adverse national and global economic conditions persist or worsen, we could
experience decreased shareholders equity, and have difficulty executing our business plans.
The adverse capital and credit market conditions could affect our liquidity. Adverse capital and
credit market conditions could affect our ability to meet liquidity needs, as well as our access to
capital and cost of capital. The capital and credit markets have been experiencing extreme
volatility and disruption for more than 12 months. In recent weeks, the volatility and disruption
have reached unprecedented levels and the markets have exerted downward pressure on availability of
liquidity and credit capacity for certain issuers. For example, recently credit spreads have
widened considerably. Our results of operations, financial condition, cash flows and capital
position could be materially adversely affected by continued disruptions in the capital and credit
markets.
- 29 -
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Item 4. |
|
Controls and Procedures. |
Disclosures and Procedures
We maintain controls and procedures designed to ensure that we are able to collect the information
we are required to disclose in the reports we file with the SEC, and to process, summarize and
disclose this information within the time periods specified in the rules of the SEC. Our chief
executive officer and chief financial officer are responsible for establishing and maintaining
these procedures and, as required by the rules of the SEC, evaluate their effectiveness. Based on
their evaluation of our disclosure controls and procedures, which took place as of the end of the
period covered by this Quarterly Report on Form 10-Q, our chief executive officer and chief
financial officer believe that these procedures are effective to ensure that we are able to
collect, process and disclose the information we are required to disclose in the reports we file
with the SEC within the required time periods.
Internal Controls
We maintain a system of internal controls designed to provide reasonable assurance that: (1)
transactions are executed in accordance with managements general or specific authorization and (2)
transactions are recorded as necessary to (a) permit preparation of financial statements in
conformity with generally accepted accounting principles and (b) maintain accountability for
assets. Access to assets is permitted only in accordance with managements general or specific
authorization and the recorded accountability for assets is compared with the existing assets at
reasonable intervals and appropriate action is taken with respect to any differences.
Changes in Internal Controls
There was no change in the Companys internal control over financial reporting that occurred during
the Companys quarter ended September 30, 2008 that has materially affected, or is reasonably
likely to materially affect, the Companys internal control over financial reporting.
PART II. OTHER INFORMATION
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Item 1. |
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Legal Proceedings. |
Gerhard Von der Ruhr et al. v. Immtech International, Inc. et. al.
In October 2003, Gerhard Von der Ruhr and his son Mark (the Von der Ruhr Plaintiffs) filed a
complaint in the United States District Court for the Northern District of Illinois against the
Company and certain officers and directors alleging breaches of a stock lock-up agreement, option
agreements and a technology license agreement by the Company. The Von de Ruhr Plaintiffs also
alleged a claim for intentional interference with contractual relations by certain officers of the
Company. The complaint sought unspecified monetary damages and punitive damages, in addition to
equitable relief and costs. In a filing made in late February 2005, the Von der Ruhr Plaintiffs
specified damages of approximately $44.5 million in damages.
- 30 -
In 2005, one of the breach of contract claims was dismissed upon the Companys motion for summary
judgment. On October 26, 2006, a preliminary pre-trial conference was held and the
court granted the Companys motions in limine to exclude plaintiffs damage claim for lost profits
and prohibited plaintiff from offering expert testimony at trial on this issue. The court
subsequently granted a motion to sever the trial on Count V, regarding the technology license
agreement, from the trial on the remaining counts. The trial on the remaining counts concluded on
December 7, 2007, and a jury returned a verdict against the Company and certain officers and
directors for a total amount of $361,704.90. The Company immediately filed a motion with the court
seeking to overturn the jury verdict, which the court subsequently denied.
In the first quarter of 2008, the Von der Ruhr Plaintiffs appealed the trial courts ruling
excluding their damage claim for lost profits. Separately, the Companys officers and directors
have appealed the jurys finding on the intentional interference with contractual relations claim.
The United States Court of Appeals for the Seventh Circuit has consolidated these appeals, and
briefing to the appellate court was completed on October 17, 2008. The appeals are now pending
decision before the appellate court.
The business, results of operations and financial condition, and therefore the value of Immtechs
securities, are subject to a number of risks. Some of those risks are set forth in the Companys
annual report on Form 10-K for fiscal year ended March 31, 2008, filed with the U.S. Securities and
Exchange Commission on June 18, 2008. The following supplements the Companys discussion of risk
factors in the Companys annual report for the fiscal year ended March 31, 2008.
The volatility and disruption of the capital and credit markets and adverse changes in the global
economy may negatively impact our business.
Due to the existing uncertainty in the capital and credit markets, our access to capital may not be
available on terms acceptable to Immtech or at all. Further, if adverse national and global
economic conditions persist or worsen, we could experience decreased shareholders equity, and have
difficulty executing our business plans.
The adverse capital and credit market conditions could affect our liquidity.
Adverse capital and credit market conditions could affect our ability to meet liquidity needs, as
well as our access to capital and cost of capital. The capital and credit markets have been
experiencing extreme volatility and disruption for more than 12 months. In recent weeks, the
volatility and disruption have reached unprecedented levels and the markets have exerted downward
pressure on availability of liquidity and credit capacity for certain issuers. For example,
recently credit spreads have widened considerably. Our results of operations, financial condition,
cash flows and capital position could be materially adversely affected by continued disruptions in
the capital and credit markets.
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Item 2. |
|
Unregistered Sales of Equity Securities and Use of Proceeds. |
Recent Sales of Unregistered Securities.
All such shares of common stock herein described as issuances below were made pursuant to Section
4(2) of the Securities Act of 1933, as amended.
Conversion of Preferred Stock to Common Stock.
On August 1, 2008, a holder of Series A Convertible Preferred Stock, $0.01 par value (Series A
Stock) converted 10,000 shares of Series A Preferred Stock into 61,012 shares of our common stock.
Preferred Stock Dividend Payment.
On October 15, 2008, we issued 478,551 shares of common stock as payment of a dividend earned on
outstanding preferred stock to the holders thereof. Holders of Series A Stock earned 48,777 shares
of common stock on 32,500 outstanding shares; holders of Series B Convertible Preferred Stock
earned 18,938 shares of common stock on 9,464 outstanding shares; holders of Series C Convertible
Preferred Stock earned 91,126 shares of common stock on 45,536 outstanding shares; holders of
Series D Convertible Preferred Stock earned 172,912 shares of common stock on 115,200 outstanding
shares; and holders of Series E Convertible Preferred Stock earned 146,798 shares of common stock
on 97,800 outstanding shares. We also paid holders of our outstanding preferred stock $26 in cash
in lieu of fractional shares.
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Item 3. |
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Defaults Upon Senior Securities. |
None
- 31 -
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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. |
None
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31.1 *
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Certification by the Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act |
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31.2 *
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Certification by the Chief Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act |
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32.1 *
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Certification by the Chief Executive Officer pursuant to Section 906 of the
Sarbanes-Oxley Act |
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32.2 *
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Certification by the Chief Financial Officer pursuant to Section 906 of the
Sarbanes-Oxley Act |
- 32 -
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
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IMMTECH PHARMACEUTICALS, INC.
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Date: November 10, 2008 |
By: |
/s/ Eric L. Sorkin
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Eric L. Sorkin |
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President and Chief Executive Officer |
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Date: November 10, 2008 |
By: |
/s/ Gary C. Parks
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Gary C. Parks |
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Treasurer, Secretary and Chief Financial Officer
(Principal Financial and Accounting Officer) |
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EXHIBIT INDEX
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Exhibit No. |
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Description |
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31.1 *
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Certification by the Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act |
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31.2 *
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Certification by the Chief Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act |
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32.1 *
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Certification by the Chief Executive Officer pursuant to Section 906 of the
Sarbanes-Oxley Act |
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32.2 *
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Certification by the Chief Financial Officer pursuant to Section 906 of the
Sarbanes-Oxley Act |