e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
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For the quarter ended: March 31, 2006
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Commission File Number:
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0-19871 |
STEMCELLS, INC.
(Exact name of registrant as specified in its charter)
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DELAWARE
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94-3078125 |
(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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identification No) |
3155 PORTER DRIVE
PALO ALTO, CA 94304
(Address of principal executive offices including zip code)
(650) 475-3100
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding twelve months (or
for such shorter periods 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,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check One):
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer 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
At April 26, 2006, there were 77,733,866 shares of Common Stock, $.01 par value, issued and
outstanding.
PART I ITEM 1 FINANCIAL STATEMENTS
STEMCELLS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
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March 31, 2006 |
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December 31, 2005 |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
30,875,874 |
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$ |
34,540,908 |
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Receivables |
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350,027 |
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201,919 |
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Other current assets |
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560,107 |
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386,966 |
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Total current assets |
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31,786,008 |
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35,129,793 |
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Marketable securities |
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2,420,467 |
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3,720,794 |
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Property, plant and equipment, net |
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3,258,350 |
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3,282,588 |
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Other assets, net |
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2,679,177 |
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2,705,513 |
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Total assets |
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$ |
40,144,002 |
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$ |
44,838,688 |
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Liabilities and stockholders equity |
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Current liabilities: |
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Accounts payable |
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$ |
722,126 |
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$ |
637,122 |
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Accrued expenses |
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937,524 |
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1,483.300 |
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Accrued wind-down expenses, current portion |
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1,181,962 |
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1,118,796 |
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Capital lease obligations, current portion |
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54,676 |
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54,676 |
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Bonds payable, current portion |
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256,667 |
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254,167 |
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Total current liabilities |
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3,152,955 |
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3,548,061 |
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Bonds payable, less current maturities |
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1,286,250 |
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1,351,250 |
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Deposits and other long-term liabilities |
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522,866 |
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522,866 |
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Accrued wind-down expenses, non-current portion |
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6,002,680 |
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6,186,930 |
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Deferred rent |
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965,859 |
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853,997 |
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Total liabilities |
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11,930,610 |
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12,463,104 |
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Stockholders equity: |
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Common stock, $.01 par value; 125,000,000
shares authorized; 65,983,046 and 65,396,022
shares issued and outstanding at March 31,
2006 and December 31, 2005, respectively |
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659,830 |
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653,960 |
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Additional paid in capital |
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219,244,727 |
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217,919,336 |
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Accumulated deficit |
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(190,136,691 |
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(185,943,565 |
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Accumulated other comprehensive loss |
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(1,554,474 |
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(254,147 |
) |
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Total stockholders equity |
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28,213,392 |
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32,375,584 |
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Total liabilities and stockholders equity |
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$ |
40,144,002 |
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$ |
44,838,688 |
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See accompanying notes to condensed consolidated financial statements.
3
PART I ITEM 1 FINANCIAL STATEMENTS
STEMCELLS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
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Three months ended |
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March 31, |
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2006 |
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2005 |
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Revenue: |
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Revenue from grants |
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$ |
37,550 |
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$ |
26,092 |
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Revenue from licensing agreements |
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4,000 |
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9,229 |
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Total revenue |
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41,550 |
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35,321 |
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Operating expenses: |
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Research and development |
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2,691,881 |
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1,618,932 |
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General and administrative |
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1,677,324 |
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1,505,203 |
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Wind-down expenses |
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156,117 |
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520,974 |
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Total operating expenses |
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4,525,322 |
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3,645,109 |
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Loss from operations |
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(4,483,772 |
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(3,609,788 |
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Other income (expense): |
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Interest income |
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339,814 |
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227,763 |
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Interest expense |
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(38,593 |
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(46,411 |
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Other income (expense) |
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(10,575 |
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(20,397 |
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Total other income (expense) |
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290,646 |
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160,955 |
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Net loss applicable to common stockholders |
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(4,193,126 |
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(3,448,833 |
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Net loss per share applicable to common
stockholders; basic and diluted |
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($0.06 |
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($0.06 |
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Weighted average shares used to compute net
loss per share applicable to common
stockholders; basic and diluted |
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65,443,062 |
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62,406,725 |
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See accompanying notes to condensed consolidated financial statements.
4
PART I ITEM 1 FINANCIAL STATEMENTS
STEMCELLS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
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Three months ended |
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March 31, |
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2006 |
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2005 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(4,193,126 |
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$ |
(3,448,833 |
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Adjustments to reconcile net loss to net cash
used in operating activities: |
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Depreciation and amortization |
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262,106 |
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273,155 |
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Amortization of deferred compensation |
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(76,382 |
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Stock-based compensation expense |
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459,197 |
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36,011 |
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Changes in operating assets and liabilities: |
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Accrued interest receivable |
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4,295 |
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(11,660 |
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Receivables |
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(152,403 |
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19,051 |
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Other current assets |
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(173,141 |
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(420,526 |
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Other assets |
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52,947 |
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Accounts payable and accrued expenses |
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(460,772 |
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(618,672 |
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Accrued wind-down expenses |
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(121,083 |
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224,427 |
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Deferred rent |
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111,862 |
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(120,094 |
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Net cash used in operating activities |
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(4,263,065 |
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(4,090,576 |
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Cash flows from investing activities: |
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Purchase of property, plant and equipment |
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(211,531 |
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(58,429 |
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Acquisition of other assets |
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(50,000 |
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Net cash used in investing activities |
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(211,531 |
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(108,429 |
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Cash flows from financing activities: |
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Proceeds from the exercise of stock options |
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91,126 |
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269,432 |
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Proceeds from the exercise of warrants |
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994,896 |
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347,327 |
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Expense from issuance of common stock |
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(213,960 |
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Repayments of capital lease obligations |
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(12,812 |
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Repayment of debt obligations |
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(62,500 |
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(59,665 |
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Net cash provided by financing activities |
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809,562 |
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544,282 |
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Decrease in cash and cash equivalents |
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(3,665,034 |
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(3,654,723 |
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Cash and cash equivalents, beginning of period |
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34,540,908 |
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41,059,532 |
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Cash and cash equivalents, end of period |
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$ |
30,875,874 |
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$ |
37,404,809 |
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Supplemental disclosure of cash flow information: |
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Interest paid |
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$ |
38,593 |
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$ |
46,411 |
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See accompanying notes to condensed consolidated financial statements
5
PART I ITEM 1. FINANCIAL STATEMENTS
Notes to Condensed Consolidated Financial Statements
(Unaudited) March 31, 2006 and 2005
NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The terms StemCells, the Company, our, we and us as used in this report refer to
StemCells Inc. The accompanying unaudited, condensed consolidated financial statements have been
prepared by the Company in accordance with generally accepted accounting principles for interim
financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X.
Accordingly, they do not include all of the information and footnotes required by generally
accepted accounting principles for complete financial statements. In the opinion of management,
the accompanying financial statements include all adjustments, consisting of normal recurring
accruals, considered necessary for a fair presentation of the financial position, results of
operations and cash flows for the periods presented. Results of operations for the three months
ended March 31, 2006, are not necessarily indicative of the results that may be expected for the
entire fiscal year ending December 31, 2006.
The balance sheet at December 31, 2005 has been derived from the audited financial statements
at that date but does not include all of the information and footnotes required for complete
financial statements in accordance with accounting principles generally accepted in the United
States of America. For the complete financial statements, refer to the audited financial
statements and footnotes thereto as of December 31, 2005, included on Form 10-K.
The Company has incurred significant operating losses and negative cash flows since inception.
It has not achieved profitability and may not be able to realize sufficient revenues to achieve or
sustain profitability in the future. The Company has limited capital resources and it will need to
raise additional capital from time to time to sustain its product development efforts, acquisition
of technologies and intellectual property rights, preclinical and clinical testing of anticipated
products, pursuit of regulatory approvals, acquisition of capital equipment, laboratory and office
facilities, establishment of production capabilities, general and administrative expenses and other
working capital requirements. To fund its operations, the Company relies on cash balances,
proceeds from equity and debt offerings, proceeds from the transfer or sale of intellectual
property rights, equipment, facilities or investments, and on government grants and collaborative
arrangements. The Company cannot be certain that such funding will be available when needed. The
financial statements do not include any adjustments to reflect the possible future effects on the
recoverability and classification of assets or the amounts and classification of liabilities that
may result from the outcome of this uncertainty.
Use of Estimates
The preparation of consolidated 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 amounts reported in the consolidated financial statements. Actual
results could differ from these estimates. Significant estimates include the accrued wind-down
expenses and the grant date fair value of share based awards recognized as compensation expense in
accordance with the provisions of Statement of Financial Accounting Standards No. 123 (Revised
2004) Share-Based Payment (SFAS 123R). See Stock-Based Compensation below.
Marketable securities
In accordance with Statement of Financial Accounting Standards No. 115 Accounting for
Certain Investments in Debt and Equity Securities", the Company has classified the Companys
short-term investments as available-for-sale marketable securities in the accompanying consolidated
financial statements. The marketable securities are stated at fair
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market value, with unrealized gains and losses reported in other comprehensive income.
Management reviews securities with unrealized losses for other than temporary impairment. A decline
in the fair value of securities that is deemed other than temporary is charged to earnings when so
deemed.
Reclassification
Certain reclassifications of prior year amounts have been made to conform to current year
presentation. Patent related expenses of $205,998 for the three-month period ended March 31, 2005
have been reclassified from research and development expense to general and administrative expense
on the consolidated statements of operations for that period to conform with current year
presentation.
Net Loss Per Share
The Company has computed net loss per common share according to the Statement of Financial
Accounting Standards (SFAS) No. 128 Earnings Per Share, which requires disclosure of basic and
diluted earnings per share. Basic earnings per share excludes any dilutive effects of options,
warrants and convertible securities, and is computed using the weighted average number of common
shares outstanding during the period. Diluted earnings per share includes the impact of
potentially dilutive securities and is computed using the weighted average of common and diluted
equivalent stock options, warrants and convertible securities outstanding during the period. Stock
options, warrants and convertible securities that are anti-dilutive are excluded from the
calculation of diluted loss per common share.
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Three months ended |
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March 31, |
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2006 |
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2005 |
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Net loss applicable to common stockholders |
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$ |
(4,193,126 |
) |
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$ |
(3,448,833 |
) |
Weighted average shares used in computing net
loss per share applicable to common
stockholders, basic and diluted. |
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65,443,062 |
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62,406,725 |
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Net loss per share applicable to common
stockholders, basic and diluted. |
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$ |
(0.06 |
) |
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$ |
(0.06 |
) |
The Company has excluded outstanding stock options and warrants from the calculation of
diluted loss per common share because all such securities are anti-dilutive for all applicable
periods presented. These outstanding securities consist of the following potential common shares:
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Outstanding at March 31, |
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2006 |
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2005 |
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Outstanding options |
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6,828,323 |
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6,728,787 |
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Outstanding warrants |
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1,995,000 |
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5,165,283 |
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Total |
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8,823,323 |
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11,894,070 |
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Stock-Based Compensation
In December 2004, the Financial Accounting Standards Board (FASB) issued SFAS123R. SFAS 123R
requires all share-based payments to employees, or to non-employee directors as compensation for
service on the Board of Directors, to be recognized as compensation expense in the consolidated
financial statements based on the fair values of such payments. The Company maintains shareholder
approved stock-based compensation plans, pursuant to which it grants stock-based compensation to
its employees, and to non-employee directors for Board service. These grants are primarily in the
form of options that allow a grantee to purchase a fixed number of shares of the Companys common
stock at a fixed exercise price equal to the market price of the shares at the date of the grant
(qualified stock option grants). The options may vest on a single date or in tranches over a
period of time, but normally they do not vest unless the grantee is still employed by or a director
of the Company on the vesting date. The compensation expense for these grants will be recognized
over the requisite service period which is typically the period over which the stock-based
compensation awards vest. The Company made no modifications to
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outstanding options with respect to vesting periods or exercise prices prior to adopting SFAS 123R.
In March 2005, the Securities and Exchange Commission (SEC) issued Staff Accounting Bulletin No.
107 (SAB 107), which provides guidance on the implementation of SFAS 123R. The Company applied the
principles of SAB 107 in conjunction with its adoption of SFAS 123R.
The Company adopted SFAS 123R effective January 1, 2006, using the modified-prospective
transition method. Under this transition method, compensation expense will be recognized based on
the grant date fair value estimated in accordance with the provisions of SFAS 123R for all new
grants effective January 1, 2006, and for options granted prior to but not vested as of December
31, 2005. Prior periods were not restated to reflect the impact of adopting the new standard and
therefore do not include compensation expense related to qualified stock option grants for those
periods. In accordance with SFAS 123R, the Company recognized stock option related compensation
expense of approximately $388,000 for the three month period ended March 31, 2006. All options
granted in the three-month period ended March 31, 2006 were qualified stock options and the related
compensation expense was recognized on a straight line basis over the vesting period of each grant
net of estimated forfeitures. The Companys estimated forfeiture rates are based on its historical
experience within separate groups of employees. The estimated fair value of the options granted
during 2006 and prior years was calculated using a Black Scholes Merton option pricing model (Black
Scholes model). The following summarizes the assumptions used in the Black Scholes model as
applied in the first quarter of 2006:
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Risk free interest rate(1) |
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4.72 |
% |
Volatility (2) |
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119.5 |
% |
Dividend yield (3) |
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0 |
% |
Expected term (years until exercise) (4) |
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6.25 |
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(1) |
|
The risk-free interest rate is based on US Treasury debt securities with
maturities close to the expected term of the option. |
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(2) |
|
Expected volatility is based on historical volatility of the Companys stock
factoring in daily share price observations. In computing expected volatility, the
length of the historical period used is equal to the length of the expected term of the
option. |
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(3) |
|
No cash dividends have been declared on the Companys common stock since the
Companys inception, and the Company currently does not anticipate paying cash
dividends over the expected term of the option. |
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(4) |
|
The expected term is equal to the average of the contractual life of the stock
option and its vesting period. |
At March 31, 2006, approximately $4,710,000 of unrecognized compensation expense related to
stock options is expected to be recognized over a weighted average period of approximately 1.56
years. The resulting effect on net loss and net loss per share attributable to common stockholders
is not likely to be representative of the effects in future periods, due to additional grants and
subsequent periods of vesting.
Prior to January 1, 2006, the Company accounted for its stock-based compensation plans under
Accounting Principles Board Opinion No. 25 (APB 25), Accounting for Stock Issued to Employees.
In accordance with APB 25, the Company recognized no compensation expense for qualified stock
option grants. For options issued with an exercise price less than the fair market value of the
shares at the date of grant, the Company recognized the difference between the exercise price and
fair market value as compensation expense in accordance with APB 25. Prior to January 1, 2006, the
Company provided pro forma disclosure amounts in accordance with Statement of Financial Accounting
Standards No. 123 Accounting for Stock-Based Compensation, (SFAS 123) as amended by
8
Statement of Financial Accounting Standards No. 148 Accounting for Stock-Based Compensation
Transition and Disclosure, (SFAS 148). As compensation expense was disclosed but not
recognized in periods prior to January 1, 2006, no cumulative adjustment for forfeitures was
recorded in 2006. The following table illustrates the effect on net loss and net loss per share if
the Company had applied the fair value recognition provisions of SFAS 123 to stock-based employee
compensation in the prior three-month period ended March 31, 2005:
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Three months ended |
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|
|
March 31, 2005 |
|
Net loss applicable to common stockholders as reported |
|
$ |
(3,448,833 |
) |
Add: Stock-based employee/director compensation expense
included in reported net loss |
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|
Deduct: Total stock-based employee/director compensation
expense under the fair value based method for all awards |
|
|
(137,461 |
) |
Net loss applicable to common stockholders pro forma |
|
$ |
(3,586,294 |
) |
Basic and diluted net loss per share applicable to
common stockholders as reported |
|
$ |
(0.06 |
) |
Basic and diluted net loss per share applicable to
common stockholders pro forma |
|
$ |
(0.06 |
) |
Shares used in basic and diluted loss per share
applicable to common stockholder amounts |
|
|
62,406,725 |
|
The Company accounts for stock options granted to non-employees in accordance with SFAS 123
and Emerging Issues Task Force (EITF) 96-18 Accounting For Equity Instruments That Are Issued
To Other Than Employees For Acquiring, Or In Conjunction With Selling, Goods Or Services", and
accordingly, recognizes as expense the estimated fair value of such options as calculated using the
Black Scholes model. The fair value is remeasured during the service period and is amortized over
the vesting period of each option or the recipients contractual arrangement, if shorter. No stock
options were issued to non-employees other than options granted to non-employee members of the
Board of Directors for service as Board members.
Revenue Recognition
Revenues from collaborative agreements and grants are recognized as earned upon either the
incurring of reimbursable expenses directly related to the particular research plan or the
completion of certain development milestones as defined within the terms of the collaborative
agreement. Payments received in advance of research performed are designated as deferred revenue.
Fees associated with substantive at risk, performance-based milestones are recognized as revenue
upon their completion, as defined in the respective agreements. Incidental assignment of
technology rights is recognized as revenue at the time of receipt.
Recent Accounting Pronouncements
Accounting for Changes and Error Corrections
In June 2005, the FASB issued Statement of Financial Accounting Standards No. 154 Accounting
Changes and Error Corrections SFAS 154). SFAS 154 replaces APB Opinion No. 20 Accounting
Changes and SFAS No. 3 Reporting Accounting Changes in Interim Financial Statements. SFAS 154
requires that a voluntary change in accounting principle be applied retrospectively with all prior
period financial statements presented on the new accounting principle. SFAS 154 also requires that
a change in method of depreciating or amortizing a long-lived non-financial asset be accounted for
prospectively as a change in estimate, and correction of errors in previously issued financial
statements should be termed a restatement. SFAS 154 is effective for accounting changes
9
and correction of errors made in fiscal years beginning after December 15, 2005. The
implementation of SFAS 154 is not expected to have a material impact on our consolidated financial
statements.
NOTE 2. RENEURON LICENSE AND SETTLEMENT AGREEMENT
In July 2005, the Company entered into a license and settlement agreement with ReNeuron
Limited, a wholly owned subsidiary of ReNeuron Group plc, a publicly listed UK corporation
(collectively referred to as ReNeuron). As part of the agreement, the Company granted ReNeuron a
license that allows ReNeuron to exploit their c-mycER conditionally immortalized adult human
neural stem cell technology for therapy and other purposes. In return for the license, StemCells
received a 7.5% fully-diluted equity interest in ReNeuron, subject to certain anti-dilution
provisions, and a cross-license to the exclusive use of ReNeurons technology for certain diseases
and conditions, including lysosomal storage diseases, spinal cord injury, cerebral palsy and
multiple sclerosis. The agreement also provides for full settlement of any potential claims that
either StemCells or ReNeuron might have had against the other in connection with any putative
infringement of certain of each partys patent rights prior to the effective date of the agreement.
The agreement is Exhibit 10.71 to the Companys Quarterly Report on Form 10-Q for the quarter
ended June 30, 2005. An amendment to the agreement was entered on April 3, 2006, a copy of which
is attached as an exhibit to this Report on Form 10-Q. The fair market value of the securities
(8,835,766 shares) as of December 31, 2005 and March 31, 2006 was approximately $3,721,000 and
$2,420,000 respectively. Changes in market value as a result of changes in market price per share
or the exchange rate between the US dollar and the British pound are accounted for under other
comprehensive loss if deemed temporary, and are not recorded as other income or loss until the
shares are disposed of and a gain or loss realized. The unrealized loss as of March 31, 2006, is
approximately $1,554,000. A decline in the fair value of securities that is deemed other than
temporary would be charged to earnings.
NOTE 3. LEASES
The Company had undertaken direct financing transactions with the State of Rhode Island
and received proceeds from the issuance of industrial revenue bonds totaling $5,000,000 to finance
the construction of a pilot manufacturing facility related to its former encapsulated cell
technology. The related leases are structured such that lease payments will fully fund all
semiannual interest payments and annual principal payments through maturity in August 2014.
Interest rates vary with the respective bonds maturities, ranging currently from 8.1% to 9.5%.
The outstanding principal at March 31, 2006 was approximately $1,543,000. The bonds contain
certain restrictive covenants, which limit among other things, the payment of cash dividends and
the sale of the related assets.
The Company entered into a fifteen-year lease for a laboratory facility in connection with a
sale and leaseback arrangement in 1997. The lease has escalating rent payments and accordingly,
the Company is recognizing rent expense on a straight-line basis. At December 31, 2005 and March
31, 2006, the Company had deferred rent liability for this facility of approximately $1,208,000 and
$1,215,000 respectively; the deferred rent liability is presented as part of the wind-down accrual.
Although the Company previously discontinued activities relating to encapsulated cell
technology, the Company remains obligated under the leases for the pilot manufacturing facility and
the laboratory facility. The Company has succeeded in subleasing the pilot manufacturing facility
and part of the laboratory facility. The aggregate income received by the Company is significantly
less than the Companys aggregate obligations under the leases, and the Companys continued receipt
of rental income is dependent on the financial ability of the occupants to comply with their
obligations under the subleases. The Company continues to seek to sublet the vacant portions of
the Rhode Island facilities, to assign or sell its interests in all of these properties, or to
otherwise arrange for the termination of its obligations under the lease obligations on these
facilities. There can be no assurance, however, that the Company will be able to dispose of these
properties in a reasonable time, if at all, or to terminate its lease obligations without the
payment of substantial consideration
As of February 1, 2001, the Company entered into a 5-year lease for 40,000 square feet of an
approximately 68,000 square foot facility located in the Stanford Research Park in Palo Alto, CA.
The facility includes space for animals, laboratories, offices, and a GMP (Good Manufacturing
Practices) suite. GMP facilities can be used to manufacture materials for clinical trials. On
December 19, 2002 the Company negotiated an amendment to the lease, which resulted in reducing the
average annual rent over the remaining term of the lease from approximately $3.7 million to $2.0
million. As part of the amendment the Company issued a letter of credit on
10
January 2, 2003 for $503,079, which was an addition to the letter of credit in the amount of
$275,000 issued at commencement of the lease, to serve as a deposit for the duration of the lease.
The Company negotiated an amendment to the lease effective April 1, 2005, which extends the term of
the lease through March 31, 2010, includes an immediate reduction in the rent per square foot, and
provides for an expansion of the leased premises by approximately 28,000 additional square feet
effective July 1, 2006. In addition, the Company has sublet some of the additional space for the
period from April 1, 2005 through June 30, 2006. The average annual rent due from the Company
under this lease for the period commencing April 1, 2005 to March 31, 2010 will be approximately $2
million before subtenant income. The lease has escalating rent payments, which the Company is
recognizing on a straight-line basis. At March 31, 2006, the Company had deferred rent liability
for this facility of approximately $966,000. At March 31, 2006 the Company has space-sharing
agreements covering in total approximately 13,000 square feet of this facility. The Company
receives the amount of base rent plus the proportionate share of the operating expenses that it
pays for such space over the term of these agreements.
NOTE 4. RELOCATION TO CALIFORNIA FROM RHODE ISLAND
In October 1999, the Company relocated to California from Rhode Island and established a wind
down reserve for the estimated lease payments and operating costs of the Rhode Island facilities
through an expected disposal date of June 30, 2000. The Company did not fully sublet the Rhode
Island facilities in 2000. Even though the Company intends to dispose of the facility at the
earliest possible time, the Companys management cannot determine with certainty a fixed date by
which such disposal will occur. In light of this uncertainty, the Company periodically
re-evaluates and adjusts the reserve. The Company considers various factors such as the Companys
lease payments through to the end of the lease, operating expenses, the current real estate market
in Rhode Island, and estimated subtenant income based on actual and projected occupancy. At
December 31, 2005 the reserve was approximately $6,098,000. The Company incurred approximately
$284,000 in operating expenses for the three-month period ending March 31, 2006, which was recorded
against the reserve. After evaluating the afore-mentioned factors the Company re-valued the
reserve to $5,970,000 at March 31, 2006, by booking an additional $156,000 as wind-down expenses.
Wind-down reserve
|
|
|
|
|
|
|
|
|
|
|
January to March |
|
|
January to December |
|
|
|
31, 2006 |
|
|
31, 2005 |
|
Accrued wind-down reserve at beginning
of period |
|
$ |
6,098,000 |
|
|
$ |
4,350,000 |
|
Less actual expenses recorded against
estimated reserve during the period |
|
|
(284,000 |
) |
|
|
(1,079,000 |
) |
Additional expense recorded to revise
estimated reserve at period-end |
|
|
156,000 |
|
|
|
2,827,000 |
|
|
|
|
|
|
|
|
Revised reserve at period-end |
|
|
5,970,000 |
|
|
|
6,098,000 |
|
Add deferred rent at period end (Note 3 |
|
|
1,215,000 |
|
|
|
1,208,000 |
|
|
|
|
|
|
|
|
Total accrued wind-down expenses at
period-end (current and non current
portion) |
|
$ |
7,185,000 |
|
|
$ |
7,306,000 |
|
|
|
|
|
|
|
|
Accrued wind-down expenses
|
|
|
|
|
|
|
|
|
Current portion |
|
$ |
1,182,000 |
|
|
$ |
1,119,000 |
|
|
|
|
|
|
|
|
Non current portion |
|
|
6,003,000 |
|
|
|
6,187,000 |
|
|
|
|
|
|
|
|
Total Accrued wind-down expenses |
|
$ |
7,185,000 |
|
|
$ |
7,306,000 |
|
|
|
|
|
|
|
|
NOTE 5. GRANTS
In September 2004, the National Institutes of Health (NIH) awarded the Company a Small
Business Technology Transfer grant of $464,000 for studies in Alzheimers disease, consisting of
approximately $308,000 for the first year and approximately $156,000 for the remainder of the grant
term, September 30, 2005 through March
11
31, 2006. The studies have been conducted by Dr. George A. Carlson of the McLaughlin Research
Institute (MRI) in Great Falls, Montana, which will receive approximately $222,000 of the total
award. The remaining $242,000 has been recognized by the Company as grant revenue as and when
resources were expended for this study. For the three month period ended March 31, 2006, the
Company recognized approximately $38,000; the Company has now drawn down in full its share of the
grant.
NOTE 6. STOCKHOLDERS EQUITY
In March 2006, a warrant issued as part of the June 16, 2004 financing arrangement was
exercised to purchase an aggregate of 526,400 shares of the Companys common stock at $1.89 per
share. The Company issued 526,400 shares of its common stock and received proceeds of
approximately $995,000. For the three month period ended March 31, 2006, the Company issued 60,624
shares from activity related to its stock option plans. The following table presents the activity
of the Companys stock option plans for the three month period ended March 31, 2006 and 2005.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
|
|
|
|
|
|
Weighted |
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Average Exercise |
|
|
|
|
|
Average Exercise |
|
|
Options |
|
Price |
|
Options |
|
Price |
Outstanding at January 1 |
|
|
6,608,109 |
|
|
$ |
3.02 |
|
|
|
6,682,201 |
|
|
$ |
2.91 |
|
Granted |
|
|
459,715 |
|
|
$ |
3.69 |
|
|
|
329,838 |
|
|
$ |
4.33 |
|
Exercised |
|
|
(60,624 |
) |
|
$ |
2.20 |
|
|
|
(173,252 |
) |
|
$ |
1.76 |
|
Canceled |
|
|
(178,877 |
) |
|
$ |
2.02 |
|
|
|
(110,000 |
) |
|
$ |
1.95 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31 |
|
|
6,828,323 |
|
|
$ |
3.10 |
|
|
|
6,728,787 |
|
|
$ |
2.79 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at March 31 |
|
|
4,448,369 |
|
|
$ |
3.02 |
|
|
|
3,623,637 |
|
|
$ |
3.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOTE 7. SUBSEQUENT EVENTS
On April 6, 2006, the Company sold 11,750,820 shares of its common stock to a limited
number of institutional investors at a price of $3.05 per share, for gross proceeds of
approximately $35,840,000. The shares were offered as a registered direct placement under the
Companys effective shelf registration statement previously filed with the Securities and Exchange
Commission. The Company received total proceeds, net of offering expenses and placement agency
fees, of approximately $33,190,000.
12
|
|
|
ITEM 2. |
|
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
The following discussion of our financial condition and the results of our operations for
the three month periods ended March 31, 2006 and 2005 should be read in conjunction with the
accompanying unaudited condensed consolidated financial statements and the related footnotes
thereto.
This report contains forward looking statements within the meaning of Section 27A of the
Securities Act and Section 21E of the Securities Exchange Act that involve substantial risks and
uncertainties. Such statements include, without limitation, all statements as to expectation or
belief and statements as to our future results of operations, the progress of our research, product
development and clinical programs, the need for, and timing of, additional capital and capital
expenditures, partnering prospects, costs of manufacture of products, the protection of and the
need for additional intellectual property rights, effects of regulations, the need for additional
facilities and potential market opportunities. Our actual results may vary materially from those
contained in such forward-looking statements because of risks to which we are subject, including
uncertainty as to whether the U.S. Food and Drug Administration (FDA) will permit us to proceed to
clinical testing of proposed products despite the novel and unproven nature of our technology; the
risk that, even if approved, our initial clinical trial could be substantially delayed beyond its
expected dates or cause us to incur substantial unanticipated costs; uncertainties regarding our
ability to obtain the capital resources needed to continue our current research and development
operations and to conduct the research, preclinical development and clinical trials necessary for
regulatory approvals; failure to obtain a corporate partner or partners to support the development
of our stem cell programs; the uncertainty regarding the outcome of the Phase I clinical trial and
any other trials we may conduct in the future; the uncertainty regarding the validity and
enforceability of issued patents; the uncertainty whether any products that may be generated in our
stem cell programs will prove clinically effective and not cause tumors or other side effects; the
uncertainty whether we will achieve revenues from product sales or become profitable; uncertainties
regarding our obligations in regard to our former encapsulated cell therapy facilities in Rhode
Island; obsolescence of our technology; competition from third parties; intellectual property
rights of third parties; litigation and other risks to which we are subject. All forward-looking
statements attributable to us or to persons acting on our behalf are expressly qualified in their
entirety by the cautionary statements and risk factors contained or referred to herein.
Overview
Since our inception in 1988, we have been primarily engaged in research and development
of human therapeutic products. Since the second half of 1999, our sole focus has been on our stem
cell technology. In October 2005, we received clearance from the FDA to initiate a Phase I
clinical trial of our human neural stem cells as a treatment for the infantile and late infantile
forms of neuronal ceroid lipofuscinosis (NCL), a rare, fatal neurodegenerative disease often
referred to as Batten disease. In March 2006, we received approval from the Institutional Review
Board of Oregon Health & Science University (OHSU) to conduct the Phase I trial at Doernbecher
Childrens Hospital at OHSU in Portland, Oregon, and the investigators have begun screening
potential patients for eligibility. Both FDA and IRB approval were required before this trial
could be initiated.
We have not derived any revenues from the sale of any products apart from license revenue for
the research use of our human neural stem cells and other patented cells and media, and we do not
expect to receive revenues from product sales for at least several years. We have not
commercialized any product and in order to do so we must, among other things, substantially
increase our research and development expenditures as research and product development efforts
accelerate and clinical trials are initiated. We had expenditures for toxicology and other studies
in preparation for submitting the Batten disease IND to the FDA and getting it cleared by the FDA,
and will incur more such expenditures for any future INDs. We have incurred annual operating
losses since inception and expect to incur substantial operating losses in the future. As a
result, we are dependent upon external financing from equity and debt offerings and revenues from
collaborative research arrangements with corporate sponsors to finance our operations. There are
no such collaborative research arrangements at this time and there can be no assurance that such
financing or partnering revenues will be available when needed or on terms acceptable to us.
Our results of operations have varied significantly from year to year and quarter to quarter
and may vary significantly in the future due to the occurrence of material recurring and
nonrecurring events, including without limitation the receipt and payment of recurring and
nonrecurring licensing payments, the initiation or termination of
13
research collaborations, the on-going expenses to lease and maintain our facilities in Rhode
Island and the increasing costs associated with our facility in California. To expand and provide
high quality systems and support to our Research and Development programs, as well as to enhance
our internal controls over financial reporting, we will need to hire more personnel, which will
lead to higher operating expenses.
Our program in neural stem and progenitor cells ranges from the preclinical stage, in which we
test human neural stem cells in small animal models of human diseases, both in-house and through
external academic collaborators, through the development phase, in which we evaluate improvements
to expansion methods and the toxicology of the cells, through the clinical development phase, with
respect to the planned clinical trial in Batten disease mentioned above. In our liver stem cell
program, we are engaged in evaluating our proprietary liver engrafting cell in various in vivo
assays, and are planning to advance our liver stem cell program into product development as rapidly
as we can. Our pancreas program is still in the discovery stage and further evaluation of the
therapeutic potential of the candidate human pancreatic stem/progenitor cell will be required.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
We believe the following critical accounting policies affect our more significant judgments
and estimates used in the preparation of our consolidated financial statements:
Use of Estimates
The preparation of consolidated 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 amounts reported in the consolidated financial statements. Actual
results could differ from these estimates. The significant estimates include the accrued wind-down
expenses related to our Rhode Island facilities and the grant date fair value of share based awards
recognized as compensation expense in accordance with the provisions of SFAS 123R.
Stock-Based Compensation
In December 2004, FASB issued SFAS 123R Share-Based Payment. This Statement is a revision
of SFAS 123 Accounting for Stock-Based Compensation and amends SFAS No. 95 Statement of Cash
Flows". SFAS 123R supersedes APB Opinion No. 25 Accounting for Stock Issued to Employees", and its
related implementation guidance. SFAS 123R covers a wide range of share-based compensation
arrangements including stock options, restricted share plans, performance-based awards, share
appreciation rights, and employee share purchase plans. The new standard is effective as of the
beginning of the first interim or annual reporting period that begins after December 15, 2005. The
Company has adopted SFAS 123R effective January 1, 2006. Adoption of the expensing requirements
will reduce the Companys reported earnings. See Stock Based Compensation under Note 1 for its
current and potential impact on net loss and net loss per share attributable to common
shareholders.
Research and Development Costs
We expense all research and development costs as incurred. Research and Development costs
include costs of personnel, external services, supplies, facilities and miscellaneous other costs.
Wind-down and Exit Costs
In connection with the wind-down of our former encapsulated cell technology operations, our
research and manufacturing operations in Lincoln, Rhode Island, and the relocation of our remaining
research and development activities and corporate headquarters to California in October 1999, we
provided a reserve for our estimate of the exit cost obligation in accordance with EITF 94-3 Other
Cost to Exit an Activity. The reserve reflects estimates of the ongoing costs of our former
research and administrative facility in Lincoln, which we hold on a lease that terminates on June
30, 2013. We are seeking to sublease, assign, sell or otherwise divest ourselves of our interest
in the facility at the earliest possible time, but we cannot determine with certainty a fixed date
by which such events will occur, if at all.
14
In determining the facility exit cost reserve amount, we are required to consider the
Companys lease payments through to the end of the lease term and estimate other relevant factors
such as facility operating expenses, real estate market conditions in Rhode Island for similar
facilities, occupancy rates and sublease rental rates projected over the course of the leasehold.
We re-evaluate the estimate each quarter, taking account of changes, if any, in each underlying
factor. The process is inherently subjective because it involves projections over time from the
date of the estimate through the end of the lease and it is not possible to determine any of the
factors except the lease payments with certainty over that period.
Management forms its best estimate on a quarterly basis, after considering actual sublease
activity, reports from our broker/realtor about current and predicted real estate market conditions
in Rhode Island, the likelihood of new subleases in the foreseeable future for the specific
facility and significant changes in the actual or projected operating expenses of the property. We
discount the projected net outflow over the term of the leasehold to arrive at the present value,
and adjust the reserve to that figure. The estimated vacancy rate for the facility is an important
assumption in determining the reserve because changes in this assumption have the greatest effect
on estimated sublease income. In addition, the vacancy rate estimate is the variable most subject
to change, while at the same time it involves the greatest judgment and uncertainty due to the
absence of highly predictive information concerning the future of the local economy and future
demand for specialized laboratory and office space in that area. The average vacancy rate of the
facility for years 2001 through 2005 was approximately 64%, varying from 49% to 80%. As of March
31, 2006, based on current information available to management, the vacancy rate is projected to be
83% for 2006, 84% for 2007, and approximately 70% from 2008 through the end of the lease. These
estimates are based on actual occupancy in 2006, expiration of subleases in 2006 and 2008,
predicted lead time for acquiring new subtenants, historical vacancy rates for the area and
assessments by our broker/realtor of future real estate market conditions. If the assumed vacancy
rate for 2008 to the end of the Lease had been five percentage points higher at March 31, 2006,,
then the reserve would have been increased by approximately $226,000; conversely, if the assumed
vacancy rate for that period were five percentage points lower, then the reserve would have been
decreased by approximately $226,000. Similarly, a 5% increase or decrease in the operating
expenses for the facility from 2006 would have increased or decreased the reserve by approximately
$135,000, and a 5% increase or decrease in the assumed average rental charge per square foot would
have increased or decreased the reserve by approximately $65,000. Management does not wait for
specific events to change its estimate, but instead uses its best efforts to anticipate them on a
quarterly basis.
The wind-down reserve at the end of December 31, 2005 was $6,098,000. For the three-month
period ended March 31, 2006 we recorded actual expenses of $284,000 against this reserve. Based on
managements evaluation of the factors mentioned, and particularly the projected vacancy rates
described above, we adjusted the reserve to $5,970,000 by recording an additional $156,000 at March
31, 2006. See Note 4 for a breakdown of these figures by quarter.
RESULTS OF OPERATIONS
Three months ended March 31, 2006 and 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
Change from previous year |
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
% |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from grants |
|
$ |
37,550 |
|
|
$ |
26,092 |
|
|
$ |
11,458 |
|
|
|
44 |
% |
Revenue from licensing agreements |
|
|
4,000 |
|
|
|
9,229 |
|
|
|
(5,229 |
) |
|
|
(57 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
41,550 |
|
|
$ |
35,321 |
|
|
$ |
6,229 |
|
|
|
18 |
% |
For the three months ended March 31, 2006 and March 31, 2005, revenue from grants totaled
approximately $38,000 and $26,000 respectively. The revenue from grants was part of a $464,000
Small Business Technology Transfer grant for studies in Alzheimers disease. Total revenue
includes licensing revenue of $4,000 and $9,000 for the three-month periods ended March 31, 2006
and 2005, respectively.
15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
Change from previous year |
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
% |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
2,691,881 |
|
|
$ |
1,618,932 |
|
|
$ |
1,072,949 |
|
|
|
66 |
% |
General and administrative |
|
|
1,677,324 |
|
|
|
1,505,203 |
|
|
|
172,121 |
|
|
|
11 |
% |
Wind-down expenses |
|
|
156,117 |
|
|
|
520,974 |
|
|
|
(364,857 |
) |
|
|
(70 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
$ |
4,525,322 |
|
|
$ |
3,645,109 |
|
|
$ |
880,213 |
|
|
|
24 |
% |
Research and development expenses totaled approximately $2,692,000 for the three months ended
March 31, 2006, compared with approximately $1,619,000 for the same period in 2005. The increase
of $1,073,000 or approximately 66% from 2005 to 2006 was primarily attributable to an increase in
personnel costs of approximately $543,000, increase in external services of approximately
$195,000; increase in supplies of approximately $83,000; increase in the allocation of deferred
rent as a result of taking on additional space and extending our lease term of
approximately$168,000; increase in other operating expenses of approximately $84,000; all of the
afore mentioned increases were primarily attributable to expanding our operations in cell
processing and clinical development. Of the approximately $543,000 increase in personnel costs,
approximately $217,000 was attributable to the expensing of stock option compensation as required
by the new accounting pronouncement SFAS 123R (see Stock Based Compensation under Note 1 above),
with the balance attributable to an increase in head count. At March 31, 2006, we had thirty three
full-time employees working in research and development and laboratory support services as compared
to thirty at March 31, 2005.
General and administrative expenses were approximately $1,677,000 for the three months ended
March 31, 2006, compared with approximately $1,505,000 for the same period in 2005. The increase
of $172,000 or approximately 11%, from 2005 to 2006 was primarily attributable to an increase in
personnel costs of approximately $373,000, of which, approximately $199,000 was attributable to the
expensing of stock option compensation as required by the new accounting pronouncement SFAS 123R
(see Stock Based Compensation under Note 1 above) with the balance attributable to an increase in
head count. The increase in personnel costs was partially offset by a decrease of approximately
$201,000 in external services and other operating expenses mainly attributable to a decrease in
recruiting fees and the cost of external services incurred in the evaluation and testing of our
system of internal control over financial reporting.
In 1999, in connection with exiting our former research facility in Rhode Island, we created a
reserve for the estimated lease payments and operating expenses related to it. The reserve has
been re-evaluated and adjusted based on assumptions relevant to real estate market conditions and
the estimated time until we could either fully sublease, assign or sell our remaining interests in
the property. At December 31, 2005 the reserve was approximately $6,098,000. For the three months
ended March 31, 2006, expenses of $284,000 net of subtenant income were recorded against this
reserve. At March 31, 2006 we re-evaluated the estimate and adjusted the reserve to approximately
$5,970,000 by recording an additional $156,000 as wind-down expenses. Wind-down expenses recorded
for the same period in 2005 were $521,000. Expenses for this facility will fluctuate based on
changes in tenant occupancy rates and other operating expenses related to the lease. Even though
it is our intent to sublease, assign, sell or otherwise divest ourselves of our interests in the
facility at the earliest possible time, we cannot determine with certainty a fixed date by which
such events will occur. In light of this uncertainty, based on estimates, we will periodically
re-evaluate and adjust the reserve, as necessary.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
Change from previous year |
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
% |
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
339,814 |
|
|
$ |
227,763 |
|
|
$ |
112,051 |
|
|
|
49 |
% |
Interest expense |
|
|
(38,593 |
) |
|
|
(46,411 |
) |
|
|
7,818 |
|
|
|
17 |
% |
Other income (expense) |
|
|
(10,575 |
) |
|
|
(20,397 |
) |
|
|
9,822 |
|
|
|
48 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense) |
|
$ |
290,646 |
|
|
$ |
160,955 |
|
|
$ |
129,691 |
|
|
|
81 |
% |
16
Interest income for the three months ended March 31, 2006 and 2005 was approximately $340,000
and $228,000 respectively. The increase in interest income in 2006 was primarily attributable to
higher yield on investments. Interest expense for the three months ended March 31, 2006 and 2005
was approximately $39,000 and $46,000 respectively. The decrease in interest expense in 2006 was
attributable to lower outstanding debt and capital lease balances in 2006 compared to 2005.
Decrease in other expense from approximately $20,000 to $11,000 was primarily attributable to a
decrease in estimated franchise tax payable.
Liquidity and Capital Resources
Since our inception, we have financed our operations through the sale of common and preferred
stock, the issuance of long-term debt and capitalized lease obligations, revenues from
collaborative agreements, research grants and interest income.
We had cash and cash equivalents totaling $30,875,874 at March 31, 2006. Cash equivalents are
invested in US Treasury debt securities with maturities of less than 90 days. The table below
summarizes our cash flows for the respective three month periods.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
Change from previous year |
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
% |
|
Net cash used in operating activities |
|
$ |
(4,263,065 |
) |
|
$ |
(4,090,576 |
) |
|
$ |
(172,489 |
) |
|
|
4 |
% |
Net cash used in investing activities |
|
|
(211,531 |
) |
|
|
(108,429 |
) |
|
|
(103,102 |
) |
|
|
95 |
% |
Net cash provided (used) by financing activities |
|
|
809,562 |
|
|
|
544,282 |
|
|
|
265,280 |
|
|
|
49 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease in cash and cash equivalents |
|
$ |
(3,665,034 |
) |
|
$ |
(3,654,723 |
) |
|
$ |
(10,311 |
) |
|
|
0.28 |
% |
The net decrease in cash and cash equivalents was approximately $3,665,000 and $3,655,000 for
the three months ended March 31, 2006 and 2005, respectively. The increase in cash used in 2006 in
comparison to the same period in 2005 was primarily attributable to the increase in operating
expenses and capital expenditures attributable to increases in personnel and external services for
our cell processing and clinical development operations. The aforementioned increase in cash outlay
was offset by an increase in cash provided by the exercise of warrants (See Note 6 Stockholders
Equity).
On April 6, 2006, we sold 11,750,820 shares of our common stock to a limited number of
institutional investors at a price of $3.05 per share, for gross proceeds of approximately
$35,840,000. The shares were offered as a registered direct placement under the Companys effective
shelf registration statement previously filed with the U.S. Securities and Exchange Commission
(SEC). We received total proceeds, net of offering expenses and placement agency fees, of
approximately $33,190,000. UBS Investment Bank (UBS) acted as placement agent in this offering. For
acting as our placement agent, UBS received fees of approximately $2,150,000 and expense
reimbursement of approximately $50,000. No warrants were issued as part of this financing
transaction.
On October 26, 2004, the Company entered into an agreement with institutional investors with
respect to the registered direct placement of 7,500,000 shares of its common stock at a purchase
price of $3.00 per share, for gross proceeds of $22,500,000. C.E. Unterberg, Towbin LLC
(Unterberg) and Shoreline Pacific, LLC (Shoreline) served as placement agents for the transaction.
The Company sold these shares under a shelf registration statement previously filed with and
declared effective by the SEC. For acting as our placement agent Unterberg and Shoreline received
fees of approximately $1,350,000 and expense reimbursement of approximately $40,000. No warrants
were issued as part of this financing transaction.
On June 16, 2004, we entered into a definitive agreement with institutional and other
accredited investors with respect to the private placement of approximately 13,160,000 shares of
our common stock at a purchase price of $1.52 per share, for gross proceeds of approximately
$20,000,000. Investors also received warrants exercisable
17
for five years to purchase approximately 3,290,000 shares of common stock at an exercise price
of $1.90 per share. Unterberg served as placement agent for the transaction. For acting as our
placement agent, Unterberg received fees totaling $1,200,192, expense reimbursement of
approximately $25,000 and a five year warrant to purchase 526,400 shares of our common stock at an
exercise price of $1.89 per share.
On December 10, 2003 we completed a $9.5 million financing transaction with Riverview Group
L.L.C. (Riverview), through the sale of 5 million shares of common stock at a price of $1.90 per
share. The closing price of our common stock on that date was $2.00 per share.
Pursuant to a Stock Purchase Agreement dated May 7, 2003, we issued 4 million shares of our
common stock to Riverview for $6.5 million, or $1.625 per share. On the date of the agreement, the
price was above the trading price of our common stock, which closed at $1.43 per share on that
date. We also agreed to issue a 2-year warrant to Riverview to purchase 1,898,000 shares of common
stock at $1.50 per share. The exercise price is subject to adjustment for stock splits, dividends,
distributions, reclassifications and similar events. The exercise price may be below the trading
market price at the time of the exercise. In the event that certain conditions are met, including
the closing sale price of the Common Stock remaining at or above $2.50 per share for 10 consecutive
trading days, we may require Riverview to exercise the warrant with respect to any remaining
warrant shares or relinquish the right to do so. We registered the resale of the purchased shares
and the shares to be issued on exercise of the warrants. On November 7, 2003 and November 11,
2003, Riverview exercised a total of 1,098,000 of these warrants at $1.50 per share by which, we
received gross proceeds of $1,647,000.
We continue to have outstanding obligations in regard to our former facilities in Lincoln,
Rhode Island, and expect to pay in 2006, based on past experience and current assumptions,
approximately $1,000,000 in lease payments and other operating expenses net of sub-tenant income.
We have subleased a portion of these facilities and are actively seeking to sublease, assign or
sell our remaining interests in these facilities. Failure to do so within a reasonable period of
time will have a material adverse effect on our liquidity and capital resources.
The following table summarizes our future contractual cash obligations (including both Rhode
Island and California leases, but excluding interest income and sub-lease income):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
April to |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payable in |
|
|
|
|
|
|
|
December |
|
|
Payable in |
|
|
Payable in |
|
|
Payable in |
|
|
Payable in |
|
|
2011 and |
|
|
|
Total |
|
|
2006 |
|
|
2007 |
|
|
2008 |
|
|
2009 |
|
|
2010 |
|
|
beyond |
|
Capital lease
payments |
|
$ |
2,279,733 |
|
|
$ |
358,094 |
|
|
$ |
332,545 |
|
|
$ |
244,531 |
|
|
$ |
244,572 |
|
|
$ |
242,560 |
|
|
$ |
857,431 |
|
Operating lease
payments |
|
|
17,275,918 |
|
|
|
2,261,420 |
|
|
|
3,165,162 |
|
|
|
3,469,017 |
|
|
|
3,536,843 |
|
|
|
1,767,304 |
|
|
|
3,076,172 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual
cash obligations |
|
$ |
19,555,651 |
|
|
$ |
2,619,514 |
|
|
$ |
3,497,707 |
|
|
$ |
3,713,548 |
|
|
$ |
3,781,415 |
|
|
$ |
2,009,864 |
|
|
$ |
3,933,603 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We have incurred significant operating losses and negative cash flows since inception. We
have not achieved profitability and may not be able to realize sufficient revenues to achieve or
sustain profitability in the future. We do not expect to be profitable in the next several years,
but rather expect to incur additional operating losses. We have limited liquidity and capital
resources and must obtain significant additional capital resources in order to sustain our product
development efforts, for acquisition of technologies and intellectual property rights, for
preclinical and clinical testing of our anticipated products, pursuit of regulatory approvals,
acquisition of capital equipment, laboratory and office facilities, establishment of production
capabilities, for general and administrative expenses and other working capital requirements. We
rely on cash balances and proceeds from equity and debt offerings, proceeds from the transfer or
sale of our intellectual property rights, equipment, facilities or investments, and government
grants and funding from collaborative arrangements, if obtainable, to fund our operations.
18
We intend to pursue opportunities to obtain additional financing in the future through equity
and debt financings, grants and collaborative research arrangements. We have a shelf registration
covering shares of our common stock up to a value of approximately $64 million that could be
available for financings. The source, timing and availability of any future financing will depend
principally upon market conditions, interest rates and, more specifically, on our progress in our
exploratory, preclinical and future clinical development programs. Funding may not be available
when neededat all, or on terms acceptable to us. Lack of necessary funds may require us to
delay, scale back or eliminate some or all of our research and product development programs,
planned clinical trials, and/or our capital expenditures or to license our potential products or
technologies to third parties.
With the exception of operating leases for facilities, we have not entered into any off
balance sheet financial arrangements and have not established any special purpose entities. We
have not guaranteed any debts or commitments of other entities or entered into any options on
non-financial assets.
19
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
In July 2005, the Company entered into an agreement with ReNeuron Limited, a wholly owned
subsidiary of ReNeuron Group plc, a publicly listed UK corporation (collectively referred to as
ReNeuron). As part of the agreement, the Company granted ReNeuron a license that allows ReNeuron
to exploit their c-mycER conditionally immortalized adult human neural stem cell technology for
therapy and other purposes. In return for the license, StemCells received a 7.5% fully-diluted
equity interest in ReNeuron, subject to certain anti-dilution provisions, and a cross-license to
the exclusive use of ReNeurons technology for certain diseases and conditions, including lysosomal
storage diseases, spinal cord injury, cerebral palsy and multiple sclerosis. The agreement also
provides for full settlement of any potential claims that either StemCells or ReNeuron might have
had against the other in connection with any putative infringement of certain of each partys
patent rights prior to the effective date of the agreement. The agreement is Exhibit 10.71 to the
Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2005. The fair market value
of the securities (8,835,766 shares) as of December 31, 2005 and March 31, 2006 was approximately
$3,721,000 and $2,420,000 respectively. Changes in market value as a result of changes in market
price per share or the exchange rate between the US dollar and the British pound are accounted for
under other comprehensive loss if deemed temporary, and are not recorded as other income or
loss until the shares are disposed and a gain or loss realized. The unrealized loss as of March
31, 2006, is approximately $1,554,000. A decline in the fair value of securities that is deemed
other than temporary would be charged to earnings.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share price at |
|
Exchange Rate at |
|
|
|
|
Company/Stock |
|
|
|
|
|
No. of Shares at |
|
March 31, 2006 in |
|
March 31, 2006 |
|
Market Value in USD |
|
Expected Future |
Symbol |
|
Exchange |
|
Associated Risks |
|
March 31, 2006 |
|
GBP (£) |
|
1 GBP = USD |
|
at March 31, 2006 |
|
Cash Flows |
ReNeuron Group plc/RENE
|
|
AIM (AIM is the London Stock
Exchanges Alternative Investment Market)
|
|
- Lower share price
- - Foreign currency translation
- - Liquidity
- - Bankruptcy
|
|
8,835,766
|
|
0.1575
|
|
1.7393
|
|
$2,420,468
|
|
(1) |
|
|
|
(1) |
|
We have not formally adopted a liquidation plan for this investment. Liquidation may be
necessary in the future to meet operating cash flow requirements. Although we are not legally
restricted from selling the stock, the share price is subject to change and the volume traded
has been very small since the stock was listed on the AIM on August 12, 2005. The performance
of ReNeuron Group plc stock since its listing does not predict its future value. |
Other than the above, no significant changes have occurred in our quantitative and qualitative
disclosures from the Form 10-K.
ITEM 4. CONTROLS AND PROCEDURES
In response to the requirement of the Sarbanes-Oxley Act of 2002, as of the end of the
period covered by this report, our chief executive officer and chief financial officer, along with
other members of management, reviewed the effectiveness of the design and operation of our
disclosure controls and procedures. Such controls and procedures are designed to ensure that
information required to be disclosed in the Companys Exchange Act reports is recorded, processed,
summarized and reported within the time periods specified in the SECs rules and forms, and that
such information is accumulated and communicated to management, including the chief executive
officer and the chief financial officer, as appropriate, to allow timely decisions regarding
required disclosure. Based on this evaluation, the chief executive officer and chief financial
officer have concluded that the Companys disclosure controls and procedures are effective.
During the most recent quarter, there were no changes in internal controls over financial
reporting that occurred during the period covered by this report that have materially affected, or
are reasonably likely to materially affect, these controls of the Company.
20
PART II ITEM 1
LEGAL PROCEEDINGS
Geron Corporation has opposed two of our European patents that relate to neural stem
cells and their uses. The oppositions were filed with the European Patent Office on December 11,
2003 (Patent No. EP-B-0594669) and February 13, 2004 (Patent No. EP-B-0669973). We filed responses
to both oppositions on September 23, 2004. Geron alleged that each patent should be revoked on
multiple grounds. Both oppositions were heard in 2005, and the patents were maintained in somewhat
altered form by the Opposition Division of the European Patent Office. The written opinions have
not yet been issued; the time for appeal begins to run in each case when the Opposition Division
opinion issues and there can be no assurance that the opposing party will not appeal. While we are
confident that, should the decision be appealed by the opposing party, it will be upheld, there can
be no guarantee of this. If we were ultimately unsuccessful in our defense of the opposed patents,
all claimed rights in the opposed patents would be lost in Europe. U.S. counterparts to these
patents are part of our issued patent portfolio; they are not subject to opposition, since that
procedure does not exist under U.S. patent law, but other types of proceedings may be available to
third parties to contest our U.S. patents.
PART II ITEM 2
CHANGES IN SECURITIES, USE OF PROCEEDS AND ISSUER PURCHASES OF EQUITY SECURITIES
None
PART II ITEM 3
DEFAULTS UPON SENIOR SECURITIES
None
PART II ITEM 4
SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None
PART II ITEM 5
OTHER INFORMATION
There were no matters required to be disclosed in a current report on Form 8-K during the
fiscal quarter covered by this report that were not so disclosed.
PART II ITEM 6
EXHIBITS
Exhibit 10.1 April 3, 2006, Amendment to License Agreement between ReNeuron Limited and
StemCells, Inc.
Exhibit 31.1 Certification of Martin McGlynn under Section 302 of the Sarbanes-Oxley Act of 2002
21
Exhibit 31.2 Certification of Rodney K. B. Young under Section 302 of the Sarbanes-Oxley Act of
2002
Exhibit 32.1 Certification of Martin McGlynn Pursuant to 18 U.S.C. Section 1350, As Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Exhibit 32.2 Certification of Rodney K. B. Young Pursuant to 18 U.S.C. Section 1350, As Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
22
SIGNATURE
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.
|
|
|
|
|
|
STEMCELLS, INC.
|
|
|
(name of Registrant)
|
|
April 27, 2006 |
/s/ Rodney K. B. Young
|
|
|
Rodney K. B. Young |
|
|
Chief Financial Officer |
|
|
23
EXHIBIT INDEX
Exhibit 10.1 April 3, 2006, Amendment to License Agreement between ReNeuron Limited and
StemCells, Inc.
Exhibit 31.1 Certification of Martin McGlynn under Section 302 of the Sarbanes-Oxley Act of 2002
Exhibit 31.2 Certification of Rodney K. B. Young under Section 302 of the Sarbanes-Oxley Act of
2002
Exhibit 32.1 Certification of Martin McGlynn Pursuant to 18 U.S.C. Section 1350, As Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Exhibit 32.2 Certification of Rodney K. B. Young Pursuant to 18 U.S.C. Section 1350, As Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
exv10w1
Exhibit 10.1
Execution Version
DATED 3rd of_April, 2006
RENEURON LIMITED
- and -
STEMCELLS INC.
AMENDMENT 5
to
LICENSE AGREEMENT dated 1 July 2005
TABLE OF CONTENTS
|
|
|
|
|
|
|
|
|
Page |
1
|
|
INTERPRETATION
|
|
1 |
2
|
|
AMENDMENT
|
|
2 |
3
|
|
FULL FORCE AND EFFECT
|
|
6 |
4
|
|
GOVERNING LAW
|
|
6 |
5
|
|
ENTIRE AGREEMENT
|
|
6 |
6
|
|
COUNTERPARTS
|
|
6 |
i
THIS AMENDMENT 5 (this Amendment) to the License Agreement (as defined below) is made as of
3rd of April, 2006 between the following parties:
(1) |
|
RENEURON LIMITED a company incorporated in England and Wales (registered number 03375897)
whose registered office is at 10 Nugent Road, Surrey Research Park, Guildford, Surrey GU2 7AF,
United Kingdom (ReN); and |
|
(2) |
|
STEMCELLS, INC. a corporation organised and existing under the laws of the State of Delaware,
whose principal place of business is at 3155 Porter Drive, Palo Alto, California 94304, United
States of America (SCI). |
WHEREAS
(A) |
|
ReN and SCI have entered into: |
|
(i) |
|
a license agreement dated 1 July 2005 (the License Agreement); |
|
|
(ii) |
|
an amendment to the License Agreement dated 1 August 2005 (Amendment 1) |
|
|
(iii) |
|
a subscription and share exchange agreement dated 1 July 2005 (the
Subscription and Share Exchange Agreement), as required by the License Agreement |
|
|
(iv) |
|
an amendment to the Subscription and Share Exchange Agreement pursuant to a
deed dated 1 August 2005 (the Deed of Amendment) |
|
|
(v) |
|
a second amendment to the License Agreement dated 9 September 2005; |
|
|
(vi) |
|
a third amendment to the License Agreement dated 28 November 2005; and |
|
|
(vii) |
|
a fourth amendment to the License Agreement dated 31 January, 2006. |
(B) |
|
The parties hereto wish to further amend the License Agreement in accordance with the terms
of this Amendment. |
IT IS AGREED as follows:
1 |
|
INTERPRETATION |
|
1.1 |
|
Save as defined in this Amendment, expressions used in this Amendment shall have the meanings
given thereto in the License Agreement. |
|
1.2 |
|
In this Amendment: |
|
1.2.1 |
|
the headings in this Amendment do not affect its construction or interpretation; |
|
|
1.2.2 |
|
a reference to a document is a reference to that document as amended or
modified from time to time in writing by the mutual consent of the parties; and |
|
|
1.2.3 |
|
the singular includes the plural and vice versa and any gender includes any
other gender. |
- 1 -
2 |
|
AMENDMENT |
|
2.1 |
|
The parties to this Amendment agree that the License Agreement shall be amended as
follows: |
|
|
|
Existing Section 1.39 of the License Agreement is hereby renumbered Section 1.40 and the
following new Section 1.39 is inserted in the License Agreement: |
1.39 Supply Agreement shall mean an agreement between the Parties so titled, of
even date herewith.
|
|
Existing Sections 1.40 through 1.42 of the License Agreement are hereby renumbered Sections
1.41 through 1.43 respectively. |
|
|
|
2.1.2 Section 2.04 of the License is deleted and the following text is substituted: |
2.04 Supply of Materials
(a) Nomination of Research Cell Lines. From time to time during the period commencing
on the Effective Date and ending upon the expiration of the Royalty Term, SCI shall
have the right to nominate one or more Cell Lines from among Cell Lines already in
ReNs possession as of the Effective Date for use by SCI solely for pre-clinical
research purposes (a Research Cell Line). Such nomination shall be rejected by ReN
only if:: (i) ReN had, prior to its receipt of such nomination from SCI, directly or
indirectly commenced in vivo pre-clinical testing for developmental purposes (such as
initial efficacy or toxicology testing) with respect to such nominated Cell Line, or
(ii) such nominated Cell Line was, as of the date of ReNs receipt of such nomination
from SCI, already created or produced by ReN for a Third Party or otherwise subject
to a pre-existing contractual restriction with a Third Party. ReN shall provide
written notice to SCI within thirty (30) days after ReNs receipt of a given Cell
Line nomination if any of the foregoing causes for rejection apply. A nominated Cell
Line that is not timely rejected by ReN as provided in this Section 2.04(a) is
referred to herein as an Approved Research Cell Line. The parties agree that the
following three Cell Lines shall be deemed to be nominated and not rejected and
therefore Approved Research Cell Lines for purposes of this Section 2.04: cortical
line CTX0E10, striatal line STR0C08, and ventral mesencephalon line VME0A04. Upon
nomination, SCI shall provide ReN with a written description of the research SCI will
conduct with each Approved Research Cell Line (similar to the e-mail already provided
to ReN by SCI with respect to the Cell Lines described in the foregoing sentence).
SCI shall provide ReN with the data and results arising from its research with each
Approved Research Cell Line.
(b) Nomination of Development Cell Lines. From time to time during the period
commencing on the Effective Date and ending upon the expiration of the Royalty Term,
SCI shall have the right to nominate one or more new (i.e., not previously
created or pre-existing) Cell Lines for creation by ReN according to
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reasonable specifications provided by SCI, for use by SCI for pre-clinical
development purposes within the SCI Field (a Development Cell Line). Such
nomination shall be rejected by ReN only if such nominated Cell Line was, as of the
date of ReNs receipt of such nomination from SCI, already created or produced by ReN
for itself, an Affiliate or a Third Party. ReN shall provide written notice to SCI
within thirty (30) days after ReNs receipt of a given Cell Line nomination if any of
the foregoing causes for rejection apply. A nominated Cell Line that is not timely
rejected by ReN as provided in this Section 2.04(b) is referred to herein as an
Approved Development Cell Line.
(c) Supply ReN shall use commercially reasonable and diligent efforts to establish
and thereafter produce (directly or through a sub-contractor) reasonable quantities
of each Approved Research Cell Line and Approved Development Cell Line, together with
methods for growth and expansion thereof. Once a Cell Line becomes an Approved
Development Cell Line, ReN shall have no right to conduct research and pre-clinical
development of such Approved Development Cell Line (and ReN shall not develop or
commercialize such Approved Development Cell Line or Products therefrom, directly or
indirectly, nor authorize or license others to do so) for so long as SCI shall
continue diligently to pursue the development and commercialization of such Approved
Development Cell Line or Products incorporating or derived from the use of such
Approved Development Cell Line.
Following the nomination by SCI of a Cell Line that is not timely rejected by ReN and
therefore becomes an Approved Cell Line, the Parties shall in good faith establish a
time-line on which ReN, using reasonable diligence, shall establish the capacity (or
have a sub-contractor establish such capacity) to supply such Approved Cell Line to
SCI pursuant to this Section 2.04. In accordance with the agreed-upon time table,
SCI shall notify ReN in advance of its projected requirements of each Approved Cell
Line and shall place firm orders for such Approved Cell Line sufficiently in advance
of the date agreed to for delivery.
(d) Standards
(i) Approved Research Cell Lines. Approved Research Cell Lines to be
supplied by ReN under this Section 2.04 (or the tissue, or corresponding
blood samples, from which such Research Cell Lines were derived) shall, at
the time of delivery to SCI, have been screened by or for ReN for
mycoplasma, sterility and communicable diseases (HTLV, HIV, HBV, HCV) using
standard testing protocols or based on documentation on the determination of
donor eligibility. Upon delivery of such Research Cell Lines, ReN shall
certify in writing (including by electronic mail) that such Research Cell
Lines have been successfully screened in accordance with the foregoing. For
the avoidance of doubt, Approved Research Cell Lines are solely for SCIs
internal research purposes and are not intended to serve as precursors for
Approved Development Cell Lines.
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(ii) Approved Development Cell Lines. Each Approved Development Cell
Line supplied by ReN under this Section 2.04 (including, without limitation,
clonal cell lots and master cell banks thereof, as described hereinbelow)
shall have been manufactured, handled, stored, transported and delivered in
compliance with applicable Laws and Regulations (as such term is defined in
the Supply Agreement) in effect at the time of such manufacture, handling,
storage, transportation and delivery (including, without limitation, with
applicable Current Good Tissue Practices and Current Good Manufacturing
Practices, as such terms are defined in the Supply Agreement and with
applicable regulations of the Recombinant DNA Advisory Committee of the
National Institutes of Health; provided, however, that clonal cell lots to
be provided under (ii)(A) below will not be cGMP compliant unless and until
selected for master cell banks to be provided under (ii)(B) below). Upon
delivery of such Approved Development Cell Line to SCI, ReN shall warrant in
writing (including by electronic mail) that such Approved Development Cell
Line meet the foregoing criteria. Furthermore, with respect to compliance
with the applicable regulations of the Recombinant DNA Advisory Committee of
the National Institutes of Health, the parties recognize that additional
testing (and corresponding time and expense) be required to establish such
compliance and therefore shall meet and agree as to whether such testing and
compliance for a given Approved Development Cell Line shall be done for all
the clonal cell lots to be provided under (ii)(A) below or just for the
master cell bank to be provided under Section (ii)(B) (and the obligation of
ReN to comply with such regulations hereunder shall be adjusted (if at all)
accordingly).
(A) Approved Development Cell Lines shall initially be delivered
to SCI in multiple clonal cell lots derived from the same tissue
source (which clonal cell lots are not required to be cGMP compliant
but which have been screened by or for ReN for mycoplasma, sterility
and communicable diseases including, without limitation, HTLV, HIV,
HBC and HCV, using standard testing protocols or based on
documentation on the determination of donor eligibility). Following
receipt of such clonal cell lots SCI will conduct such in vivo and in
vitro pre-clinical testing as it deems appropriate to establish
whether any of such clonal cell lots meet internally established
performance criteria as a pre-condition for moving forward with
pre-clinical and clinical development of Approved Development Cell
Lines within the SCI Field.
(B) Promptly following completion of such internal testing, SCI
will notify ReN as to which if any of such clonal cell lots SCI
wishes to continue to develop as an Approved Development Cell Line.
With respect to each clonal cell lot that SCI indicates that it
wishes to continue to develop, ReN shall diligently
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manufacture and deliver to SCI a master cell bank (MCB) in
compliance with applicable Laws and Regulations in effect at the
time of manufacture. Those clonal cell lots as to which SCI notifies
ReN that SCI has no further interest shall thereafter no longer be
considered Approved Development Cell Lines and may be exploited by
ReN as it sees fit.
(C) Within 180 days following its receipt of each MCB, SCI shall
test such MCB for compliance with the applicable specifications, in
accordance with the procedures set forth in Section 5.1 of the Supply
Agreement. In the event that an MCB fails to meet the applicable
specifications or otherwise fails to comply with applicable Laws and
Regulations (as determined in accordance with Section 5.1 of the
Supply Agreement), the parties shall in good faith consult in an
effort to ascertain the reasons for such failure and to identify
mutually acceptable means to assure the production of MCBs that meet
applicable specifications, Laws and Regulations. ReN shall, at SCIs
request and at ReNs expense, promptly manufacture and transfer to
SCI a second MCB for the relevant Approved Development Cell Line. If
such second MCB fails to meet the applicable specifications or
otherwise fails to comply with applicable Laws and Regulations (as
determined in accordance with Section 5.1 of the Supply Agreement)
SCI may, on notice to ReN, either (i) require a transfer of
technology as provided in Section 5.1.5 of the Supply Agreement,
whereunder ReNs right to supply Development Cell Lines pursuant to
this Agreement, and SCIs obligation to purchase such Cell Lines from
ReN, shall terminate, or (ii) terminate the License and the Supply
Agreement.
(D) Except as expressly provided in subsection (C), above, in
the event of a second MCB failure, SCIs sole and exclusive remedy,
and ReNs sole obligation and liability, with respect to any Approved
Development Cell Line or Approved Research Cell Line that fails to
meet the standards and criteria set forth in this Section 2.04(d)
shall be replacement of such Cell Line by ReN or refund by ReN of any
amounts paid by SCI therefore.
(e) Payment. With respect to Approved Research Cell Lines supplied to SCI pursuant to
this Agreement, SCI shall reimburse ReN for the Fully Burdened Manufacturing Costs
and Cost of External Services with respect to such Cell Lines. With respect to
Approved Development Cell Lines supplied to SCI pursuant to this Agreement, SCI shall
reimburse ReN in the amount of one and one half (1.5) times ReNs Fully Burdened
Manufacturing Costs plus one times ReNs Cost of External Services with respect to
such Cell Lines. The terms Fully Burdened Manufacturing Costs and Cost of
External Services are as defined in Exhibit A
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to the Supply Agreement (except that references therein to Product shall refer to
such Approved Research Cell Lines or Approved Development Cell Lines, as the case may
be). SCI shall pay ReNeuron within thirty (30) days of receipt of ReNeurons invoice
for the foregoing amounts follow delivery of the applicable Cell Lines in accordance
with the provisions above (except to the extent provided otherwise in the Supply
Agreement).
(f) Inspections. With respect to each Approved Development Cell Line isolated,
produced and supplied by ReN pursuant to this Section 2.04, SCI shall have the right,
no more than once in any 12 month period, during ordinary working hours and with no
fewer than 10 days prior written notice to ReN, to conduct reasonable quality
assurance audits of ReNs applicable production and testing facilities (or such
facilities of ReNs applicable subcontractor for such Approved Development Cell
Line). In addition, SCI shall have the right, on 15 days prior notice to ReN, to
inspect such facilities as frequently as is reasonably required in order to confirm
compliance with requests or directions of regulatory authorities with respect to such
facilities.
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FULL FORCE AND EFFECT |
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Except as expressly amended by this Amendment, the License Agreement shall remain unchanged
and continue in full force and effect as provided therein. |
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GOVERNING LAW |
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This Amendment shall be governed by and interpreted in accordance with the laws of the
State of California, without regard to conflicts of laws principles. |
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ENTIRE AGREEMENT |
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This Amendment and the License Agreement contain the full understanding of the parties
with respect to the subject matter hereof. No waiver, alteration or modification of any of
the provisions hereof shall be binding unless made in writing and signed by the parties by
their respective officers thereunto duly authorized. |
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COUNTERPARTS |
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This Amendment may be executed in any number of counterparts (which shall include
facsimile counterparts), each of which shall be deemed an original but all of which taken
together shall constitute one and the same instrument. |
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IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be executed in their names by
their properly and duly authorized officers or representatives as of the date first above written.
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RENEURON LIMITED |
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By:
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Title:
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STEMCELLS, INC. |
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By:
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Title:
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exv31w1
Exhibit 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
UNDER SECTION 302 OF THE SARBANES-OXLEY ACT
I, Martin McGlynn, certify that:
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I have reviewed this quarterly report on Form 10-Q of StemCells, Inc.; |
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Based on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in light of
the circumstances under which such statements were made, not misleading with respect to the
period covered by this report; |
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(3) |
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Based on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the registrant as of, and for, the periods
presented in this quarterly report; |
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(4) |
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The registrants other certifying officer(s) and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) for the registrant and have: |
(a) designed such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure that
material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly
during the period in which this report is being prepared;
(b) designed such internal control over financial reporting, or caused such
internal control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial reporting and
the preparation of financial statements for external purposes in accordance with
generally accepted accounting principles;
(c) evaluated the effectiveness of the registrants disclosure controls and
procedures and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period covered by this
report based on such evaluation; and
(d) disclosed in this report any change in the registrants internal control
over financial reporting that occurred during the registrants most recent fiscal
quarter (the registrants fourth fiscal quarter in the case of an annual report)
that has materially affected, or is reasonably likely to materially affect, the
registrants internal control over financial reporting; and
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The registrants other certifying officer(s) and I have disclosed, based on our most
recent evaluation of internal control over financial reporting, to the registrants
auditors and the audit committee of the registrants board of directors (or persons
performing the equivalent functions): |
(a) all significant deficiencies and material weaknesses in the design or operation
of internal control over financial reporting which are reasonably likely to
adversely affect the registrants ability to record, process, summarize and report
financial information; and
(b) any fraud, whether or not material, that involves management or other employees
who have a significant role in the registrants internal control over financial
reporting.
Date:
April 27, 2006
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/s/ Martin McGlynn
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Martin McGlynn |
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President and Chief Executive Officer |
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exv31w2
Exhibit 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER
UNDER SECTION 302 OF THE SARBANES-OXLEY ACT
I, Rodney K. B. Young, certify that:
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I have reviewed this quarterly report on Form 10-Q of StemCells, Inc.; |
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Based on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in light of
the circumstances under which such statements were made, not misleading with respect to the
period covered by this report; |
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Based on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the registrant as of, and for, the periods
presented in this quarterly report; |
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(4) |
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The registrants other certifying officer(s) and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) for the registrant and have: |
(a) designed such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure that
material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly
during the period in which this report is being prepared;
(b) designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with
generally accepted accounting principles;
(c) evaluated the effectiveness of the registrants disclosure controls and
procedures and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period covered by this
report based on such evaluation; and
(d) disclosed in this report any change in the registrants internal control
over financial reporting that occurred during the registrants most recent fiscal
quarter (the registrants fourth fiscal quarter in the case of an annual report)
that has materially affected, or is reasonably likely to materially affect, the
registrants internal control over financial reporting; and
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The registrants other certifying officer(s) and I have disclosed, based on our most
recent evaluation of internal control over financial reporting, to the registrants
auditors and the audit committee of the registrants board of directors (or persons
performing the equivalent functions): |
(a) all significant deficiencies and material weaknesses in the design or operation
of internal control over financial reporting which are reasonably likely to
adversely affect the registrants ability to record, process, summarize and report
financial information; and
(b) any fraud, whether or not material, that involves management or other employees
who have a significant role in the registrants internal control over financial
reporting.
Date:
April 27, 2006
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/s/ Rodney K. B. Young
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Rodney K. B. Young |
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Chief Financial Officer |
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exv32w1
Exhibit 32.1
Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
In connection with the StemCells, Inc. (the Company) Quarterly on Form 10-Q for the period
ending March 31, 2006 as filed with the Securities and Exchange Commission on the date hereof (the
Report), I, Martin McGlynn, President and Chief Executive Officer of the Company, certify
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002, that, to the best of my knowledge:
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The Report fully complies with the requirements of Section 13(a) or 15(d) of
the Securities Exchange Act of 1934, as amended; and |
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The information contained in the Report fairly presents, in all material
respects, the financial condition and results of operations of the Company. |
A signed original of this written statement required by Section 906 has been provided to StemCells,
Inc. and will be retained by StemCells, Inc. and furnished to the Securities and Exchange
Commission or its staff upon request.
Date:
April 27, 2006
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/s/ Martin McGlynn
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Martin McGlynn |
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President and Chief Executive Officer |
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exv32w2
Exhibit 32.2
Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
In connection with the StemCells, Inc. (the Company) Quarterly on Form 10-Q for the period
ending March 31, 2006 as filed with the Securities and Exchange Commission on the date hereof (the
Report), I, Rodney K. B. Young, Chief Financial Officer of the Company, certify pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to
the best of my knowledge:
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The Report fully complies with the requirements of Section 13(a) or 15(d) of
the Securities Exchange Act of 1934, as amended; and |
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(2). |
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The information contained in the Report fairly presents, in all material
respects, the financial condition and results of operations of the Company. |
A signed original of this written statement required by Section 906 has been provided to StemCells,
Inc. and will be retained by StemCells, Inc. and furnished to the Securities and Exchange
Commission or its staff upon request.
Date:
April 27, 2006
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/s/ Rodney K.B. Young
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Rodney K. B. Young |
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Chief Financial Officer |
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