e10vq
FORM 10-Q
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2006
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 000-30171
SANGAMO BIOSCIENCES, INC.
(exact name of small business issuer as specified in its charter)
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Delaware
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68-0359556 |
(State or other jurisdiction of incorporation or organization)
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(IRS Employer Identification No.) |
501 Canal Blvd, Suite A100
Richmond, California 94804
(Address of principal executive offices)
(510) 970-6000
(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 Act of 1934 during the preceding 12 months (or for such
shorter period that the registrant was required to file such reports), and (2) has been subject to
such filing requirements for the past 90 days:
Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act.
Large accelerated filer o Accelerated filer þ 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
As of May 5, 2006, 30,738,861 shares of the issuers common stock, par value $0.01 per share,
were outstanding.
INDEX
SANGAMO BIOSCIENCES, INC.
Some statements contained in this report are forward-looking with respect to our operations,
research and development activities, operating results and financial condition. Statements that
are forward-looking in nature should be read with caution because they involve risks and
uncertainties, which are included, for example, in specific and general discussions about:
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our strategy; |
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product development and commercialization of our products; |
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clinical trials; |
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revenues from existing and new collaborations; |
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sufficiency of our cash resources; |
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our research and development and other expenses; |
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our operational and legal risks; and |
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our plans, objectives, expectations and intentions and any other statements that are not historical facts. |
Various terms and expressions similar to them are intended to identify these cautionary statements.
These terms include: anticipates, believes, continues, could, estimates, expects,
intends, may, plans, seeks, should and will. Actual results may differ materially from
those expressed or implied in those statements. Factors that could cause these differences include,
but are not limited to, those discussed under Risk Factors and Managements Discussion and
Analysis of Financial Condition and Results of Operations. Sangamo undertakes no obligation to
publicly release any revisions to forward-looking statements to reflect events or circumstances
arising after the date of this report. Readers are cautioned not to place undue reliance on the
forward-looking statements, which speak only as of the date of this Quarterly Report.
2
PART 1. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
SANGAMO BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
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March 31, |
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December 31, |
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2006 |
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2005 (1) |
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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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$ |
13,398 |
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$ |
18,507 |
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Marketable securities |
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29,140 |
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28,449 |
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Interest receivable |
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200 |
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218 |
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Accounts receivable |
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292 |
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971 |
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Prepaid expenses |
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334 |
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317 |
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Total current assets |
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43,364 |
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48,462 |
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Property and equipment, net |
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637 |
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472 |
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Other assets |
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49 |
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49 |
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Total assets |
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$ |
44,050 |
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$ |
48,983 |
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Liabilities and stockholders equity |
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Current liabilities: |
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Accounts payable and accrued liabilities |
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$ |
794 |
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$ |
1,534 |
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Accrued compensation and employee benefits |
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496 |
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933 |
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Deferred revenue |
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3,435 |
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4,327 |
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Total current liabilities |
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4,725 |
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6,794 |
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Deferred revenue, non-current portion |
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3,750 |
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4,375 |
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Total liabilities |
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8,475 |
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11,169 |
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Stockholders equity: |
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Common stock, $0.01 par value; 80,000,000
shares authorized, 30,700,165 and 30,570,912
shares issued and outstanding at March 31,
2006 and December 31, 2005, respectively |
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31 |
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31 |
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Additional paid-in capital |
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148,647 |
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148,131 |
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Accumulated deficit |
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(113,152 |
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(110,408 |
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Accumulated other comprehensive income |
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49 |
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60 |
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Total stockholders equity |
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35,575 |
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37,814 |
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Total liabilities and stockholders equity |
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$ |
44,050 |
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$ |
48,983 |
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(1) |
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Amounts derived from Audited Consolidated Statements dated December 31, 2005 filed as a part
of Form 10-K. |
See accompanying notes.
3
SANGAMO BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(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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Revenues: |
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Collaboration agreements |
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$ |
1,873 |
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$ |
180 |
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Federal government research grants |
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263 |
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76 |
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Total revenues |
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2,136 |
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256 |
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Operating expenses: |
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Research and development |
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3,589 |
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2,597 |
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General and administrative |
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1,755 |
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1,239 |
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Total operating expenses |
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5,344 |
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3,836 |
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Loss from operations |
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(3,208 |
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(3,580 |
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Interest and other income, net
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464 |
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27 |
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Net loss |
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$ |
(2,744 |
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$ |
(3,553 |
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Basic and diluted net loss per share |
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$ |
(0.09 |
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$ |
(0.14 |
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Shares used in computing basic and diluted net loss per share |
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30,600 |
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25,337 |
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See accompanying notes.
4
SANGAMO BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(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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Operating Activities: |
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Net loss |
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$ |
(2,744 |
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$ |
(3,553 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation |
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49 |
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78 |
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Amortization of premium / discount on investments |
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(25 |
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114 |
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Realized (gain) / loss on investments |
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(5 |
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68 |
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Stock-based compensation |
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451 |
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101 |
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Changes in operating assets and liabilities: |
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Interest receivable |
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18 |
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53 |
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Accounts receivable |
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679 |
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343 |
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Prepaid expenses and other assets |
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(17 |
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Accounts payable and accrued liabilities |
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(740 |
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(278 |
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Accrued compensation and employee benefits |
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(437 |
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(245 |
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Deferred revenue |
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(1,517 |
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(61 |
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Net cash used in operating activities |
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(4,288 |
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(3,380 |
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Investing Activities: |
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Purchases of investments |
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(6,186 |
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(6,124 |
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Maturities of investments |
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5,514 |
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8,455 |
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Purchases of property and equipment |
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(214 |
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(28 |
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Net cash provided by / (used in) investing activities |
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(886 |
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2,303 |
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Financing Activities: |
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Proceeds from issuance of common stock |
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65 |
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71 |
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Net cash provided by financing activities |
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64 |
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71 |
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Net decrease in cash and cash equivalents |
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(5,109 |
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(1,006 |
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Cash and cash equivalents, beginning of period |
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18,507 |
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8,626 |
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Cash and cash equivalents, end of period |
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$ |
13,398 |
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$ |
7,620 |
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See accompanying notes.
5
SANGAMO BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
March 31, 2006
NOTE 1-BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
BASIS OF PRESENTATION
The accompanying unaudited condensed consolidated financial statements of Sangamo Biosciences,
Inc. (Sangamo or the Company) have been prepared in accordance with generally accepted
accounting principles for interim financial information and pursuant to the rules and regulations
of the Securities and Exchange Commission (SEC). 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, all adjustments (consisting of normal recurring
adjustments) considered necessary for a fair presentation have been included. The condensed
consolidated financial statements include the accounts of Sangamo and its wholly-owned subsidiary,
Gendaq Limited, after elimination of all material intercompany balances and transactions. Operating
results for the three-months ended March 31, 2006 are not necessarily indicative of the results
that may be expected for the year ending December 31, 2006. These financial statements should be
read in conjunction with the financial statements and footnotes thereto for the year ended December
31, 2005, included in Sangamos Form 10-K as filed with the SEC.
USE OF ESTIMATES
The preparation of financial statements in conformity with generally accepted accounting
principles requires management to make estimates and assumptions that affect the amounts reported
in the financial statements and the accompanying notes. Actual results could differ from those
estimates.
Certain
reclassifications of prior period amounts have been made to the Condensed Consolidated
Financial Statements to conform to the current period presentation,
including the reclassification of patent prosecution expenses to
general and administrative from research and development expense. The
reclassifications were immaterial and had no impact on the
Companys net loss or accumulated deficit.
FOREIGN CURRENCY TRANSLATION
The Company records foreign currency transactions at the exchange rate prevailing at the date
of the transaction. Monetary assets and liabilities denominated in foreign currency are translated
into U.S. dollars at the exchange rates in effect at the balance sheet date. All currency
translation adjustments arising from foreign currency transactions are recorded through profit and
loss.
REVENUE RECOGNITION
In accordance with Staff Accounting Bulletin No. 104, Revenue Recognition, revenue from
research activities made under strategic partnering agreements is recognized as the services are
provided when there is persuasive evidence that an arrangement exists, delivery has occurred, the
price is fixed or determinable, and collectibility is reasonably assured. Amounts received in
advance under such agreements are deferred until the above criteria are met and the research
services are performed. Sangamos federal government research grants are typically multi-year
agreements and provide for the reimbursement of qualified expenses for research and development as
defined under the terms of the grant agreement. Revenue under grant agreements is recognized when
the related qualified research expenses are incurred. Grant reimbursements are received on a
quarterly or monthly basis and are subject to the issuing agencys right of audit.
Sangamo recognizes revenue from its Enabling Technology collaborations when ZFP-based products
are delivered to the collaborators, persuasive evidence of an agreement exists, there are no
unfulfilled obligations, the price is fixed and determinable, and collectibility is reasonably
assured. Generally, Sangamo receives partial payments from these collaborations prior to the
delivery of ZFP-based products and the recognition of these revenues is deferred until the
ZFP-based products are delivered, the risk of ownership has passed to the collaborator and all
performance obligations have been satisfied. Upfront or signature payments received upon the
signing of an Enabling Technology agreement are generally recognized ratably over the applicable
period of the agreement or as ZFP-based products are delivered.
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Milestone payments under research, partnering, or licensing agreements are recognized as
revenue upon the achievement of mutually agreed upon milestones, provided that (i) the milestone
event is substantive and its achievement is not reasonably assured at the inception of the
agreement, and (ii) there are no performance obligations associated with the milestone payment.
In accordance with Emerging Issues Task Force Issue No. 00-21, Revenue Arrangements with
Multiple Deliverables, revenue arrangements entered into after June 15, 2003, that include
multiple deliverables, are divided into separate units of accounting if the deliverables meet
certain criteria, including whether the fair value of the delivered items can be determined and
whether there is evidence of fair value of the undelivered items. In addition, the consideration is
allocated among the separate units of accounting based on their fair values, and the applicable
revenue recognition criteria are considered separately for each of the separate units of
accounting.
RESEARCH AND DEVELOPMENT EXPENSES
Research and development expenses consist of costs incurred for Company-sponsored as well as
collaborative research and development activities. These costs include direct and research-related
overhead expenses, which include salaries and other personnel-related expenses,
stock-based compensation, facility costs, supplies and depreciation of facilities and laboratory
equipment, as well as the cost of funding research at universities and other research institutions,
and are expensed as incurred. Costs to acquire technologies that are utilized in research and
development and that have no alternative future use are expensed as incurred.
STOCK-BASED COMPENSATION
Prior to January 1, 2006, we accounted for our stock-based employee compensation arrangements
under the intrinsic value method prescribed by Accounting Principles Board Opinion No. 25,
Accounting for Stock Issued to Employees (APB No. 25), as allowed by SFAS No. 123, Accounting for
Stock-based Compensation (SFAS No. 123), as amended by SFAS No. 148, Accounting for Stock-Based
Compensation Transition and Disclosure (SFAS No. 148). As a result, no expense was recognized for
options to purchase our common stock that were granted with an exercise price equal to fair market
value at the date of grant and no expense was recognized in connection with purchases under our
employee stock purchase plan for the years ended December 31, 2005 or 2004. In December 2004, the
Financial Accounting Standards Board (FASB) issued SFAS No. 123 (revised 2004) Share-Based Payment
(SFAS No. 123R), which replaces SFAS No. 123 and supersedes APB No. 25. SFAS No. 123R requires all
share-based payments to employees, including grants of employee stock options, to be recognized in
the financial statements based on their fair values beginning with the first interim or annual
period after June 15, 2005. Subsequent to the effective date, the pro forma disclosures previously
permitted under SFAS No. 123 are no longer an alternative to financial statement recognition.
Effective January 1, 2006, we have adopted SFAS No. 123R using the modified prospective method.
Under this method, compensation cost recognized during the three-month period ended March 31, 2006,
includes: (a) compensation cost for all share-based payments granted prior to, but not yet vested
as of December 31, 2005, based on the grant date fair value estimated in accordance with the
original provisions of SFAS No. 123 amortized on an accelerated basis over the options vesting
period, and (b) compensation cost for all share-based payments granted subsequent to December 31,
2005, based on the grant-date fair value estimated in accordance with the provisions of SFAS No.
123R amortized on a straight-line basis over the options vesting period. Results for prior periods
have not been restated. As a result of adopting SFAS No. 123R on January 1, 2006, our net loss is
greater by $430,000 for the three-month period ended March 31, 2006 than had we continued to
account for stock-based employee compensation under APB No. 25. Basic and diluted net loss per
share for the three-month period ended March 31, 2006 would have been $0.08 had we not adopted SFAS
No. 123R, compared to reported basic and diluted net loss per share of $0.09. The adoption of SFAS
No. 123R had no impact on cash flows from operations or financing.
Stock Option Plan
Sangamos 2004 Stock Option Plan (the 2004 Option Plan), which supersedes the 2000 Stock
Option Plan, provides for the issuance of common stock and grants of options for common stock
to employees, officers, directors and consultants. The exercise price per share will be no
less than 85 percent of the fair value per share of common stock on the option grant date, and
the option term will not exceed ten years. If the person to whom the option is granted is a 10
percent stockholder, and the option granted qualifies as an Incentive Stock Option Grant, then
the exercise price per share will not be less than 110 percent of the fair value per share of
common stock on the option grant date, and the option term will not exceed five years. Options
granted under the 2004 Option Plan generally vest over four years at a rate of 25 percent one
year from the grant date and one thirty-sixth per month thereafter and expire ten years
7
after the grant, or earlier upon employment termination. Options granted pursuant to the 2004
Option Plan may be exercised prior to vesting, with the related shares subject to Sangamos right
to repurchase the shares that have not vested at the issue price if the option holder terminates
employment. The right of repurchase lapses over the original option vesting period, as described
above. A total of 6.5 million shares are reserved for issuance pursuant to the 2004 Option Plan.
The number of shares authorized for issuance automatically increases on the first trading day of
the fiscal year by an amount equal to 3.0 percent of the total number of shares of our common stock
outstanding on the last trading day of the preceding fiscal year.
Employee Stock Purchase Plan
The Board of Directors adopted the 2000 Employee Stock Purchase Plan in February 2000,
effective upon the completion of Sangamos initial public offering of its common stock. Sangamo
reserved a total of 400,000 shares of common stock for issuance under the plan. Eligible employees
may purchase common stock at 85 percent of the lesser of the fair market value of Sangamos common
stock on the first day of the applicable two-year offering period or the last day of the applicable
six-month purchase period. The reserve for shares available under the plan will automatically
increase on the first trading day of the second fiscal quarter each year, beginning in 2001, by an
amount equal to 1 percent of the total number of outstanding shares of our common stock on the last
trading day of the immediately preceding first fiscal quarter.
As of March 31, 2006, total shares reserved for future awards under all plans were 8,296,385.
Adoption of FAS 123R
Employee stock-based compensation expense recognized in the first quarter of 2006 was calculated
based on awards ultimately expected to vest and has been reduced for estimated forfeitures. FAS
123R requires forfeitures to be estimated at the time of grant and revised, if necessary, in
subsequent periods if actual forfeitures differ from those estimates. A forfeiture rate of 10% is
applied to the stock-based compensation expense, determined through historical experience of employee stock
option exercises. The following table shows total stock-based employee compensation expense (see
above for types of stock-based employee arrangements) included in the condensed consolidated
statement of operations for the three-month period ended March 31, 2006 (in thousands):
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Three months ended |
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March 31, 2006 |
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Costs and expenses: |
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Research and development |
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$ |
317 |
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General and administrative |
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113 |
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Total stock-based compensation expense |
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$ |
430 |
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There was no capitalized stock-based employee compensation cost as of March 31, 2006. There were no
recognized tax benefits during the quarter ended March 31, 2006.
As of March 31, 2006, total compensation cost related nonvested stock options not yet recognized
was $3.3 million, which is expected to be allocated to expense over a weighted average period of 48 months.
Pro Forma Information for Period Prior to Adoption of FAS 123R
The following table illustrates the effect on net loss and net loss per share had we applied the
fair value recognition provisions of SFAS No. 123 to account for our employee stock option and
employee stock purchase plans for the three-month period ended March 31, 2005 because stock-based
employee compensation was not accounted for using the fair value recognition method during that
period. For purposes of pro forma disclosure, the estimated fair value of the stock awards, as
prescribed by SFAS No. 123, is amortized to expense over the vesting period of such awards (in
thousands, except per share data).
8
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Three months ended |
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March 31, 2005 (1) |
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Net loss, as reported |
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$ |
(3,553 |
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Deduct: Total stock-based employee compensation
expense determined under fair value method |
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(547 |
) |
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Pro forma net loss |
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$ |
(4,100 |
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Basic and diluted net loss per share: |
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As reported |
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$ |
(0.14 |
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Pro forma |
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$ |
(0.16 |
) |
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(1) |
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During the preparation of footnotes to the condensed consolidated
financial statements for our quarterly filings during fiscal year
2006, we determined that the calculation of our net loss pro forma
reported under SFAS No. 123 for fiscal year 2005, as reported in that
year, did not appropriately reflect the effect of SFAS No. 123 for
certain options granted prior to January 1, 2006. Accordingly, the
amount of net loss pro forma reported under SFAS No. 123 for the
first quarter of fiscal 2005 presented in the table above has been
revised, resulting in an increase in the previously reported amount of
pro forma net loss of $338,000 or $0.01 per basic and diluted share.
This revision had no effect on our previously reported condensed
consolidated results of operations or financial condition. |
The historical pro forma impact of applying the fair value method prescribed by SFAS No. 123 is not
representative of the impact that may be expected in the future due to changes resulting from
additional grants in future years and changes in assumptions such as volatility, interest rates and
expected life used to estimate fair value of the grants in future years.
Valuation Assumptions
The employee stock-based compensation expense recognized under FAS123R and presented in the pro
forma disclosure required under FAS123 was determined using the Black Scholes option valuation
model. Option valuation models require the input of subjective assumptions and these
assumptions can vary over time.
We primarily base our determination of expected volatility through our assessment of the historical
volatility of our Common Stock. We do not believe that we are able to rely on our historical
exercise and post-vested termination activity to provide accurate data for estimating our expected
term for use in determining the fair value of these options. Therefore, as allowed by Staff
Accounting Bulletin (SAB) No. 107, Share-Based Payment , we have opted to use the simplified method
for estimating our expected term equal to the midpoint between the vesting period and the
contractual term.
The weightedaverage assumptions used for estimating the fair value of the employee stock options
are as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2006 |
|
2005 |
Risk-free interest rate |
|
|
4.95 |
% |
|
|
4.24 |
% |
Expected life of option |
|
6.25 yrs |
|
|
5.00 yrs |
|
Expected dividend yield of stock |
|
|
0 |
% |
|
|
0 |
% |
Expected volatility |
|
|
.82 |
|
|
|
1.0 |
|
The
weightedaverage assumptions used for estimating the fair value
of the employees purchase rights are as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2006 |
|
2005 |
Risk-free interest rate |
|
|
3.17 - 4.26 |
% |
|
|
2.71 |
% |
Expected life of option |
|
0.5 - 1 yr |
|
|
0.5 - 2 yrs |
|
Expected dividend yield of stock |
|
|
0 |
% |
|
|
0 |
% |
Expected volatility |
|
|
0.413 - 0.636 |
|
|
|
.70 |
|
Stock Option Activity
9
A summary of Sangamos stock option activity follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
Shares Available |
|
|
|
|
|
Weighted-Average |
|
|
for Grant of |
|
Number of |
|
Exercise per |
|
|
Options |
|
Shares |
|
Share Price |
Outstanding at January 1, 2006 |
|
|
3,256,505 |
|
|
|
3,874,097 |
|
|
$ |
4.27 |
|
Options granted |
|
|
(34,500 |
) |
|
|
34,500 |
|
|
$ |
5.11 |
|
Options exercised |
|
|
|
|
|
|
(142,836 |
) |
|
$ |
5.99 |
|
Options canceled |
|
|
40,578 |
|
|
|
(40,578 |
) |
|
$ |
6.41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2006 |
|
|
3,262,583 |
|
|
|
3,725,183 |
|
|
$ |
5.48 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
There were no shares subject to Sangamos right of repurchase as of March 31, 2006. The
intrinsic value of options exercised during the first quarter of
2006 and 2005 were $790,000 and $392,000,
respectively.
The weighted-average estimated fair value per share of options granted during the three months
ended March 31, 2006 and 2005 were $3.76 and $3.41, respectively, based upon the assumptions
in the Black-Scholes valuation model described above. The
weighted-average estimated fair value per share of employee purchase
rights during the three months
ended March 31, 2006 and 2005 were $1.70 and $1.72, respectively, based upon the assumptions
in the Black-Scholes valuation model described above.
The following table summarizes information with respect to stock options outstanding at March
31, 2006:
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
Remaining |
|
|
Number |
|
Contractual Life |
Range of Exercise Price |
|
of Shares |
|
(In Years) |
$0.05 - $0.17 |
|
|
461,583 |
|
|
|
2.07 |
|
$0.23 - $3.61 |
|
|
470,153 |
|
|
|
6.70 |
|
$3.78 - $5.19 |
|
|
1,494,497 |
|
|
|
8.63 |
|
$5.36 - $7.49 |
|
|
705,750 |
|
|
|
6.83 |
|
$7.57 - $11.13 |
|
|
361,700 |
|
|
|
4.88 |
|
$14.50 - $17.65 |
|
|
231,500 |
|
|
|
5.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,725,183 |
|
|
|
6.59 |
|
|
|
|
|
|
|
|
|
|
At
March 31, 2006, the aggregate intrinsic value of the outstanding
options was $6.2 million.
Sangamo
did not grant any nonqualified common stock options to consultants
during the three months ended March 31, 2006 and 2005. The Company granted 15,000 and 10,000 nonqualified common stock
options to consultants at exercise prices that range from $3.00 to $3.80 per
share for services rendered in 2005 and 2004, respectively. Such options are included in the option
tables disclosed above. The options generally vest over four years at
a rate of 25 percent one year from grant date and
one-thirty-sixth per month thereafter and expire ten years after the
grant date. Total nonqualified stock-based compensation expense was
$21,000 and $100,000 in the three months ended March 31, 2006
and 2005, respectively. The fair value of these options was
determined using the Black-Scholes model.
10
NOTE 2-BASIC AND DILUTED NET LOSS PER SHARE
Basic and diluted net loss per share have been computed using the weighted-average number of
shares of common stock outstanding during the period. Weighted-average shares outstanding used to
calculate the reported net loss per common share were equal to shares used to compute basic and
diluted net loss per common share.
NOTE 3-COMPREHENSIVE LOSS
Comprehensive loss is comprised of net loss and other comprehensive income (loss). Other
comprehensive loss includes certain changes in stockholders equity that are excluded from net
loss, which includes unrealized gains and losses on our available-for-sale securities.
Comprehensive loss and its components are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
|
|
2006 |
|
|
2005 |
|
Net loss |
|
$ |
(2,744 |
) |
|
$ |
(3,553 |
) |
Changes in unrealized (losses)/gains on securities available-for-sale |
|
|
(11 |
) |
|
|
58 |
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(2,755 |
) |
|
$ |
(3,495 |
) |
|
|
|
|
|
|
|
NOTE 4-MAJOR CUSTOMERS, PARTNERSHIPS AND STRATEGIC ALLIANCES
Strategic Partnership with Edwards Lifesciences Corporation
In January 2000, we announced a therapeutic product development collaboration with Edwards
Lifesciences Corporation (Edwards). Under the agreement, we have licensed to Edwards, on a
worldwide, exclusive basis, ZFP Therapeutics for use in the activation of VEGFs and VEGF receptors
in ischemic cardiovascular and vascular diseases. Edwards purchased a $5.0 million note that
converted, together with accrued interest, into 333,333 shares of common stock at the time of our
initial public offering (IPO) at the IPO price. In March 2000, Edwards purchased a $7.5 million
convertible note in exchange for a right of first refusal for three years to negotiate a license
for additional ZFP Therapeutics in cardiovascular and peripheral vascular diseases. That right of
first refusal was not exercised and terminated in March 2003. Together with accrued interest, this
note converted into common stock at the time of our initial public offering at the IPO price.
Through 2001, we received $2 million in research funding from Edwards and a $1.4 million milestone
payment for delivery of a lead ZFP Therapeutic product candidate. In November 2002, Edwards signed
an amendment to the original agreement and agreed to provide up to $3.5 million in research and
development funding, including $2.95 million for research and development activities performed in
2002 and 2003. The filing of the IND for PAD in 2004, and the achievement of other research-related
milestones in 2003, triggered a total of $1.0 million in milestone payments from Edwards in the
first quarter of 2004. There were no revenues attributable to milestone achievement and
collaborative research and development performed under the Edwards agreements for both the
three-month periods ended March 31, 2006 and 2005.
Our license agreement with Edwards Lifesciences provides Edwards with worldwide, exclusive
rights for ZFP Therapeutics for the activation of VEGF and VEGF receptors for the treatment and
prevention of ischemic cardiovascular and vascular disease in humans. We have retained all rights
to use our technology for all therapeutic applications of VEGF activation outside of the treatment
and prevention of ischemic cardiovascular and vascular disease in humans. During the first quarter
of 2005, Sangamo commenced a Phase I clinical trial for the treatment of diabetic neuropathy using
a ZFP Therapeutic for the activation of VEGF. Edwards has stated that its rights include diabetic
neuropathy and consequently our activities relating to diabetic neuropathy constitute a breach of
the agreement. We strongly disagree with the Edwards assertion because diabetic neuropathy is a
neurological disease and not an ischemic vascular disease and therefore is outside the scope of the
Edwards license. Sangamo and Edwards are in discussions regarding this issue.
In the future, Sangamo may receive milestone payments and royalties under this agreement. We
have received $2.5 million in milestone payments to date and we could receive $27.0 million in
additional milestone payments under the agreement if all future milestones are met for the first
product developed under the agreement. Any subsequent products developed under the agreement may
generate up to $15.0 million in milestone payments each. We would also receive royalties on any
sales of products generated under the agreement and these royalty obligations would continue until
the expiration of the last-to-expire patent covering products developed under the agreement on a
country-by-country basis. Based on currently issued patents, these royalty obligations would last
through January 12, 2019. The development of any products is subject to numerous risks and no
assurance can be given that any
11
products will successfully be developed under this agreement. See Risk Factors Our gene
regulation technology is relatively new, and if we are unable to use this technology in all our
intended applications, it would limit our revenue opportunities.
Under the Sangamo-Edwards agreement, we were responsible for advancing product candidates into
preclinical animal testing. Edwards had responsibility for preclinical development, regulatory
affairs, clinical development, and the sales and marketing of ZFP Therapeutic products developed
under the agreement. Sangamo may receive milestone payments in connection with the development and
commercialization of the first product under this agreement and may also receive royalties on
product sales. As part of the November 2002 amendment to our original agreement, Edwards also
entered into a joint collaboration with us to evaluate ZFP TFs for the regulation of a second
therapeutic gene target, phospholamban (PLN), for the treatment of congestive heart failure. Under
the amended agreement, Sangamo granted Edwards a right of first refusal to Sangamos ZFP TFs for
the regulation of PLN. This right of first refusal terminated on June 30, 2004. On August 14, 2003
Edwards and Sangamo entered into a Third Amendment to the original license agreement. Under this
amendment, Sangamo received payment for research and development milestones associated with the
VEGF and PLN programs.
There is no assurance that the companies will achieve the development and commercialization
milestones anticipated in these agreements. Edwards has the right to terminate the agreement at any
time upon 90 days written notice. In the event of termination, we retain all payments previously
received as well as the right to develop and commercialize all related products.
Agreement with LifeScan for Regenerative Medicine
In September 2004, we announced that we had entered into a research agreement with LifeScan,
Inc., a Johnson & Johnson company. The agreement provides LifeScan with our ZFP TFs for use in a
program to develop therapeutic cell lines as a potential treatment for diabetes. In December 2004,
and again in September 2005, this agreement was expanded to include additional targets important in
diabetes. The agreements represented our first collaboration in the field of regenerative medicine.
During the three months ended March 31, 2006 and 2005, revenues attributable to collaborative
research and development performed under the LifeScan agreements were $150,000 and $55,000,
respectively. Related research and development costs and expenses performed under the LifeScan
agreements were $8,000 and $18,000 during the three months ended March 31, 2006 and 2005,
respectively.
Enabling Technology Collaborations for Pharmaceutical Protein Production
We have established several research collaborations in this area. In December 2004, we
announced a research collaboration agreement with Pfizer Inc to use our ZFP technology to develop
enhanced cell lines for protein pharmaceutical production. The scope of this agreement was expanded
in January 2006 and provided further research funding from Pfizer to develop additional cell lines
for enhanced protein production. Under the terms of the agreement, Pfizer is funding research at
Sangamo and Sangamo will provide our proprietary ZFP technology for Pfizer to assess its
feasibility for use in mammalian cell-based protein production. We are generating novel cell lines
and vector systems for enhanced protein production as well as novel technology for rapid creation
of new production cell lines. During the first quarter of 2006 and first quarter of 2005, we
received $775,000 and $500,000 in research-related funding under our agreements with Pfizer.
Revenues attributable to collaborative research and development performed under the Pfizer
agreement were $150,000 and $125,000 during the three months ended March 31, 2006 and 2005,
respectively. Related research and development costs and expenses performed under the Pfizer
agreement were $57,000 and $22,000 during the three months ended March 31, 2006 and 2005,
respectively.
Plant Agriculture Agreements
Sangamo scientists and collaborators have shown that ZFP TFs and ZFNs can be used to regulate
and modify genes in plants with similar efficacy to that shown in various mammalian cells and
organisms. The ability to regulate gene expression with engineered ZFP TFs may lead to the creation
of new plants that increase crop yields, lower production costs, are more resistant to herbicides,
pesticides, and plant pathogens; and permit the development of branded agricultural products with
unique nutritional and processing characteristics. In addition, ZFNs may be used to facilitate the
efficient and reproducible generation of transgenic plants. Effective as of October 1, 2005, we
entered into a Research License and Commercial Option Agreement with Dow AgroSciences LLC (DAS),
a wholly owned indirect subsidiary of Dow Chemical Corporation. Under this agreement, we will
provide DAS with access to our proprietary ZFP technology and the exclusive right to use our ZFP
technology to modify the genomes or alter the nucleic acid or protein expression of plant cells,
plants, or plant cell cultures. We will retain rights to use plants or plant-derived products to
deliver ZFP TFs or ZPF nucleases (ZFNs) into human or animals for diagnostic, therapeutic, or
prophylactic purposes.
12
Our agreement with DAS provides for an initial three-year research term during which time we
will work together to validate and optimize the application of our ZFP technology to plants, plant
cells and plant cell cultures. A joint committee having equal representation from both companies
will oversee this research. During the initial three-year research term, DAS will have the option
to obtain a commercial license to sell products incorporating or derived from plant cells generated
using our ZFP technology, including agricultural crops, industrial products and plant-derived
biopharmaceuticals. This commercial license will be exclusive for all such products other than
animal and human health products. In the event that DAS exercises this option, DAS may elect to
extend the research program beyond the initial three-year term on a year-to-year basis.
Pursuant to the Research License and Commercial Option Agreement, DAS made an initial cash
payment to us of $7.5 million and agreed to purchase up to $4.0 million of our common stock in the
next financing transaction meeting certain criteria. In November 2005, the Company sold
approximately 1.0 million shares of common stock to DAS at a price of $3.85 per share, resulting in
gross proceeds of $3.9 million. In addition, DAS will provide between $4.0 and $6.0 million in
research funding over the initial three-year research term and may make an additional payment of up
to $4.0 million in research milestone payments to us during this same period, depending on the
success of the research program. In the event that DAS elects to extend the research program beyond
the initial three-year term, DAS will provide additional research funding. If DAS exercises its
option to obtain a commercial license, we will be entitled to full payment of the $4.0 million in
research milestones, a one-time exercise fee of $6.0 million, minimum annual payments of up to
$25.25 million, development and commercialization milestone payments for each product, and
royalties on sales of products. Furthermore, DAS will have the right to sublicense our ZFP
technology to third parties for use in plant cells, plants, or plant cell cultures, and we will be
entitled to 25% of any cash consideration received by DAS under such sublicenses.
We have agreed to supply DAS and its sublicensees with ZFP TFs and/or ZFNs for both research
and commercial use. If DAS exercises its option to obtain a commercial license, DAS may request
that we transfer, at DASs expense, the ZFP manufacturing technology to DAS or to a mutually
agreed-upon contract manufacturer.
The Research License and Commercial Option Agreement will terminate automatically if DAS fails
to exercise its option for a commercial license by the end of the initial three-year research term.
DAS may also terminate the agreement at the end of the second year of the initial research term if
the joint committee overseeing the research determines that disappointing research results have
made it unlikely that DAS will exercise the option; we are guaranteed to receive $4.0 million in
research funding from DAS prior to such a termination. Following DASs exercise of the option and
payment of the exercise fee, DAS may terminate the agreement at any time. In addition, each party
may terminate the agreement upon an uncured material breach of the other party. In the event of any
termination of the agreement, all rights to use our ZFP technology will revert to us, and DAS will
no longer be permitted to practice our ZFP technology or to develop or, except in limited
circumstances, commercialize any products derived from our ZFP technology. Revenues related to the
research license under the DAS agreement are being recognized ratably over the initial three-year
research term of the agreement and were $625,000 during the three months ended March 31, 2006.
Revenues attributable to collaborative research and development performed under the DAS agreement
were $948,070 during the three months ended March 31, 2006. Related costs and expenses incurred
under the DAS agreement were $862,500 during the three months ended March 31, 2006.
13
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The discussion in Managements Discussion and Analysis of Financial Condition and Results of
Operations contains trend analysis, estimates and other forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended. These forward-looking statements include, without limitation,
statements containing the words believes, anticipates, expects, continue, and other words
of similar import or the negative of those terms or expressions. Such forward-looking statements
are subject to known and unknown risks, uncertainties, estimates and other factors that may cause
the actual results, performance or achievements of the Company, or industry results, to be
materially different from any future results, performance or achievements expressed or implied by
such forward-looking statements. Actual results could differ materially from those set forth in
such forward-looking statements as a result of, but not limited to, the Risk Factors described
below. You should read the following discussion and analysis along with the financial statements
and notes attached to those statements included elsewhere in this report and in our annual report
on Form 10-K for the year ended December 31, 2005 as filed with the Securities and Exchange
Commission on March 13, 2006.
Overview
We were incorporated in June 1995. From our inception through March 31, 2006, our activities
related primarily to establishing and operating a biotechnology research and development
organization and developing relationships with our corporate collaborators. Our scientific and
business development endeavors currently focus on the engineering of novel zinc finger DNA binding
proteins (ZFPs) for the regulation and modification of genes. We have incurred net losses since
inception and expect to incur losses in the future as we continue our research and development
activities. To date, we have funded our operations primarily through the issuance of equity
securities, borrowings, payments from federal government research grants and from corporate
collaborators and strategic partners. As of March 31, 2006, we had an accumulated deficit of $113.2
million.
Our revenues have consisted primarily of revenues from our corporate partners for ZFP TFs and
ZFNs, contractual payments from strategic partners for research programs and research milestones,
and Federal government research grant funding. We expect revenues will continue to fluctuate from
period to period and there can be no assurance that new collaborations or partner fundings will
continue beyond their initial terms.
Commencing in 2005, we have placed more emphasis on higher-value therapeutic product
development and related strategic partnerships and less emphasis on our Enabling Technology
collaborations. We believe this shift in emphasis has the potential to increase the return on
investment to our stockholders by allocating capital resources to higher value, therapeutic product
development activities. At the same time, it may reduce our revenues over the next several years
and it increases our financial risk by increasing expenses associated with product development. We
have filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration
(FDA) and have initiated a Phase 1 clinical trial of a ZFP Therapeutic in patients with diabetic
neuropathy during the first quarter of 2005. Development of novel therapeutic products is costly
and is subject to a lengthy and uncertain regulatory process by the FDA. Our future products are
gene-based therapeutics. Adverse events in both our own clinical program and other programs in gene
therapy may have a negative impact on regulatory approval, the willingness of potential commercial
partners to enter into agreements and the perception of the public.
Research and development expenses consist primarily of salaries and related personnel
expenses, including stock-based compensation, laboratory supplies, allocated facilities costs,
subcontracted research expenses, trademark registration and technology licenses. Research and
development costs incurred in connection with collaborator-funded activities are expensed as
incurred. We believe that continued investment in research and development is critical to attaining
our strategic objectives. We expect these expenses will increase significantly as we increase our
focus on development of ZFP Therapeutics. The Company is also developing zinc finger nucleases
(ZFNs) for therapeutic gene correction and therapeutic gene modification as a treatment for certain
monogenic and infectious diseases. Additionally, in order to develop ZFP TFs and ZFNs as
commercially relevant therapeutics, we expect to expend additional resources for expertise in the
manufacturing, regulatory affairs and clinical research aspects of biotherapeutic development.
General and administrative expenses consist primarily of salaries and related personnel
expenses for executive, finance and administrative personnel,
stock-based compensation, professional
fees, patent prosecution expenses, allocated facilities costs and other general corporate expenses.
As we pursue commercial development of our therapeutic leads we expect the business aspects of the
14
Company to become more complex. We may be required in the future to add personnel and incur
additional costs related to the maturity of our business.
Critical Accounting Estimates
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at
the date of the financial statements and the reported amounts of revenues and expenses during the
reporting period. Actual results could differ from those estimates. Sangamo believes the following
critical accounting policies have significant effect in the preparation of our consolidated
financial statements.
Revenue Recognition
In accordance with Staff Accounting Bulletin No. 104, Revenue Recognition, revenue from
research activities made under strategic partnering agreements is recognized as the services are
provided when there is persuasive evidence that an arrangement exists, delivery has occurred, the
price is fixed or determinable, and collectibility is reasonably assured. Amounts received under
such agreements are deferred until the above criteria are met and the research services are
performed. Sangamos federal government research grants are typically multi-year agreements and
provide for the reimbursement of qualified expenses for research and development as defined under
the terms of the grant agreement. Revenue under grant agreements is recognized when the related
research expenses are incurred. Grant reimbursements are typically received on a quarterly basis
and are subject to the issuing agencys right of audit.
Sangamo recognizes revenue from its Enabling Technology collaborations when ZFP-based products
are delivered to the collaborators, persuasive evidence of an agreement exists, there are no
unfulfilled obligations, the price is fixed and determinable, and collectibility is reasonably
assured. Generally, Sangamo receives partial payments from these collaborations prior to the
delivery of ZFP-based products and the recognition of these revenues is deferred until the
ZFP-based products are delivered, the risk of ownership has passed to the collaborator and all
performance obligations have been satisfied. Upfront or signature payments received upon the
signing of an Enabling Technology agreement are generally recognized ratably over the applicable
period of the agreement or as ZFP-based products are delivered.
Milestone payments under research, partnering, or licensing agreements are recognized as
revenue upon the achievement of mutually agreed upon milestones, provided that (i) the milestone
event is substantive and its achievement is not reasonably assured at the inception of the
agreement, and (ii) there are no further significant performance obligations associated with the
milestone payment.
In accordance with Emerging Issues Task Force Issue No. 00-21, Revenue Arrangements with
Multiple Deliverables, revenue arrangements entered into after June 15, 2003, that include
multiple deliverables, are divided into separate units of accounting if the deliverables meet
certain criteria, including whether the fair value of the delivered items can be determined and
whether there is evidence of fair value of the undelivered items. In addition, the consideration is
allocated among the separate units of accounting based on their fair values, and the applicable
revenue recognition criterion is considered separately for each of the separate units of
accounting.
Stock-Based Compensation
Prior to January 1, 2006, we accounted for our stock-based employee compensation arrangements under
the intrinsic value method prescribed by Accounting Principles Board Opinion No. 25, Accounting for
Stock Issued to Employees (APB No. 25), as allowed by SFAS No. 123, Accounting for Stock-based
Compensation (SFAS No. 123), as amended by SFAS No. 148, Accounting for Stock-Based Compensation
Transition and Disclosure (SFAS No. 148). As a result, no expense was recognized for options to
purchase our common stock that were granted with an exercise price equal to fair market value at
the date of grant and no expense was recognized in connection with purchases under our employee
stock purchase plan for the years ended December 31, 2005 or 2004. In December 2004, the Financial
Accounting Standards Board (FASB) issued SFAS No. 123 (revised 2004) Share-Based Payment (SFAS No.
123R), which replaces SFAS No. 123 and supersedes APB No. 25. SFAS No. 123R requires all
share-based payments to employees, including grants of employee stock options, to be recognized in
the financial statements based on their fair values beginning with the first interim or annual
period after June 15, 2005. Subsequent to the effective date, the pro forma disclosures previously
permitted under SFAS No. 123 are no longer an alternative to financial statement recognition.
Effective January 1, 2006,
15
we have adopted SFAS No. 123R using the modified prospective method. Under this method,
compensation cost recognized during the three-month period ended March 31, 2006, includes: (a)
compensation cost for all share-based payments granted prior to, but not yet vested as of December
31, 2005, based on the grant date fair value estimated in accordance with the original provisions
of SFAS No. 123 amortized on an accelerated basis over the options vesting period, and (b)
compensation cost for all share-based payments granted subsequent to December 31, 2005, based on
the grant-date fair value estimated in accordance with the provisions of SFAS No. 123R amortized on
a straight-line basis over the options vesting period. Results for prior periods have
not been restated. As a result of adopting SFAS No. 123R on January 1, 2006, our net loss is
greater by $430,000 for the three-month period ended March 31, 2006 than had we continued to
account for stock-based employee compensation under APB No. 25. Net loss per share for the
three-month period ended March 31, 2006 would have been $0.08 had we not adopted SFAS No. 123R,
compared to reported basic net loss per share of $0.09. The adoption of SFAS No. 123R had no
impact on cash flows from operations or financing.
As of March 31, 2006, total compensation cost related nonvested stock options not yet recognized
was $3.3 million, which is expected to be allocated to expense over a weighted average period of 48
months.
16
RESULTS OF OPERATIONS
Three months ended March 31, 2006 and 2005
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
(in thousands, except percentage values) |
|
|
|
2006 |
|
|
2005 |
|
|
Change |
|
|
% |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration agreements |
|
$ |
1,873 |
|
|
$ |
180 |
|
|
$ |
1,693 |
|
|
|
941 |
% |
Federal government research grants |
|
|
263 |
|
|
|
76 |
|
|
|
187 |
|
|
|
246 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
2,136 |
|
|
$ |
256 |
|
|
$ |
1,880 |
|
|
|
734 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We are increasing the emphasis of our research and development activities on ZFP Therapeutics
and are moving away from our historic emphasis on Enabling Technology agreements. Over the next
several years, this change in resource allocation will reduce our revenues.
Total revenues increased to $2.1 million for the three months ended March 31, 2006 from
$256,000 in the corresponding period in 2005. The increase for the three months ended March 31,
2006 was principally due to revenues in connection with our Research License and Commercial Option
Agreement with Dow AgroSciences LLC (DAS), a wholly owned indirect subsidiary of Dow Chemical
Corporation, of $1.6 million. We anticipate continued revenues from collaboration agreements
through the end of 2006, and we have applied for, and plan to continue to apply for, federal
government research grants in the future to support the development of applications of our
technology platform. Although we have negotiated collaboration agreements and received federal
government research grants in the past, we cannot assure you that these efforts will be successful
in the future.
Operating Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
(in thousands, except percentage values) |
|
|
|
2006 |
|
|
2005 |
|
|
Change |
|
|
% |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
3,589 |
|
|
$ |
2,597 |
|
|
$ |
992 |
|
|
|
38 |
% |
General and administrative |
|
|
1,755 |
|
|
|
1,239 |
|
|
|
516 |
|
|
|
42 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
$ |
5,344 |
|
|
$ |
3,836 |
|
|
$ |
1,508 |
|
|
|
39 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
Over the past three fiscal years, research and development expenses have consisted primarily
of salaries and related personnel expenses, including stock-based compensation, laboratory
supplies, allocated facilities costs, subcontracted research expenses, trademark registration and
technology licenses. We expect to continue to devote substantial resources to research and
development in the future and expect research and development expenses to increase in the next
several years if we are successful in advancing our ZFP Therapeutic product candidates into
clinical trials. To the extent we collaborate with others with respect to clinical trials,
increases in research and development expenses may be reduced or avoided.
Research and development expenses for the first quarter of 2006 increased to $3.6 million
compared to $2.6 million for the first quarter of 2005. The increase in research and development
expenses for the three months ended March 31, 2006 was primarily attributable to increased external
development expenses of $316,000, primarily associated with our diabetic neuropathy program,
increased personnel and lab supply expenses of $230,000 and $157,000, respectively, due to
increased headcount and recognition of $317,000 in stock-based employee compensation expense due to
adoption of SFAS No. 123R.
General and administrative
General and administrative expenses consist primarily of salaries and related personnel
expenses for executive, finance and administrative personnel,
stock-based compensation, professional
fees, patent prosecution expenses, allocated facilities costs, other general corporate expenses and
stock-based compensation. As we pursue commercial development of our therapeutic leads, we expect
the business aspects of the Company to become more complex. We may be required in the future to add
personnel and incur additional costs related to the maturity of our business.
17
General and administrative expenses were $1.8 million in the three months ended March 31,
2006, as compared to $1.2 million during the corresponding period in 2005. This increase is
primarily related to higher expenses related to patent prosecution and consulting of $170,000 and
$157,000, respectively, and recognition of $113,000 in stock-based compensation expense due to
adoption of SFAS No.123R.
Interest income, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
(in thousands, except percentage values) |
|
|
2006 |
|
2005 |
|
Change |
|
% |
Interest and other income, net |
|
$ |
464 |
|
|
$ |
27 |
|
|
$ |
437 |
|
|
|
1,619 |
% |
Interest and other income, net, increased to $464,000 for the three months ended March 31,
2006 from $27,000 in the corresponding period in 2005. The increase was primarily related to higher
interest income of $243,000 related to higher average investment balances during the quarter ended
March 31, 2006. In addition, a foreign currency translation gain of $35,000 was recorded during
the quarter ended March 31, 2006 versus a foreign currency translation loss of $85,000 during the
corresponding quarter in 2005.
Liquidity and Capital Resources
Since inception, we have financed our operations primarily through the sale of equity
securities, payments from corporate collaborators, federal government research grants and financing
activities such as a bank line of credit. As of March 31, 2006, we had cash, cash equivalents,
investments and interest receivable totaling $42.7 million.
Net cash used for operating activities was $4.3 million for the three months ended March 31,
2006. Net cash used consisted primarily of the net loss for the three-month period of $2.7 million
and a net change of $2.0 million in operating assets and liabilities. This was partially offset by
stock-based compensation charges of $451,000 and depreciation of $49,000. For the three months
ended March 31, 2005, net cash used consisted primarily of the net loss for the three-month period
of $3.6 million and a net change of $188,000 in operating assets and liabilities. This was
partially offset by amortization of premium / discount on investment of $114,000, other stock-based
compensation charges of $101,000, depreciation of $78,000 and realized losses on investments of
$68,000.
Net cash used in investing activities was $886,000 for the three months ended March 31, 2006
and was primarily comprised of cash used to purchase investments and fixed assets of $6.2 million
and $214,000, respectively, partially offset by cash proceeds associated with maturities of
investments of $5.5 million. For the three months ended March 31, 2005, net cash provided by
investing activities was $2.3 million and was primarily comprised of proceeds associated with
maturities of investments of $8.5 million partially offset by cash used to purchase investments of
$6.1 million.
Net cash provided by financing activities for the three-month periods ended March 31, 2006 and
2005 was $65,000 and $71,000, respectively. Proceeds from both years were solely related to the
issuance of common stock.
While we expect our rate of cash usage to increase in the future, in particular, in support of
our product development endeavors, we believe that the available cash resources, funds received
from corporate collaborators, strategic partners and federal government research grants will be
sufficient to finance our operations through 2007. We may need to raise additional capital to fund
our ZFP Therapeutic development activities. Additional capital may not be available in terms
acceptable to us, or at all. If adequate funds are not available, our business and our ability to
develop our technology and our ZFP Therapeutic products would be harmed.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our exposure to market risk for changes in interest rates relates primarily to our cash equivalents
and investments. The investments are available-for-sale. We do not use derivative financial
instruments in our investment portfolio. We attempt to ensure the safety and preservation of our
invested funds by limiting default and market risks. Our cash and investments policy emphasizes
liquidity and preservation of principal over other portfolio considerations. We select investments
that maximize interest income to the extent possible within these guidelines. We satisfy liquidity
requirements by investing excess cash in securities with different maturities to match projected
cash needs and limit concentration of credit risk by diversifying our investments among a variety
of high credit-quality issuers. We mitigate default risk by investing in only investment-grade
securities. The portfolio includes marketable securities
18
with active secondary or resale markets to ensure portfolio liquidity. All investments have a fixed
interest rate and are carried at market value, which approximates cost.
Our market risks at March 31, 2006 have not changed materially from those discussed in Item 7A of
our Form 10-K for the year ended December 31, 2005 on file with the Securities and Exchange
Commission.
19
ITEM 4. CONTROLS AND PROCEDURES
(a) Evaluation of Disclosure Controls and Procedures
The Companys management, with the participation of the Companys Chief Executive Officer and
Principal Financial Officer, evaluated the effectiveness of the Companys disclosure controls and
procedures (as defined in Exchange Act Rule 13a-15(e) or 15d-15(e)) as of the end of the period
covered by this report. Based on that evaluation, the Chief Executive Officer and Principal
Financial Officer concluded that the Companys disclosure controls and procedures as of the end of
the period covered by this report are functioning effectively to provide reasonable assurance that
the information required to be disclosed by the Company in reports filed under the Securities
Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods
specified in the SECs rules and forms.
(b) Change in Internal Control over Financial Reporting
No change in the Companys internal control over financial reporting occurred during the
Companys most recent fiscal quarter that has materially affected, or is reasonably likely to
materially affect, the Companys internal control over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
We are not party to any material pending legal proceedings, other than routine litigation
incidental to our business.
ITEM 1A. RISKS FACTORS
This Form 10-Q contains forward-looking information based on our current expectations. Because our
actual results may differ materially from any forward-looking
statements made by or on behalf of
Sangamo, this section includes a discussion of important factors that could affect our actual
future results, including, but not limited to, our revenues, expenses, net loss and loss per share.
We have increased the focus of our research and development programs on human therapeutics, which
may increase operating expenditures and the uncertainty of our business. We are increasing the
emphasis and focus of our research and development activities on ZFP Therapeutics and have
relatively fewer resources invested in our Enabling Technology programs. In the short term, this
change in resource allocation may reduce our revenues and increase operating expenditures due to
larger financial outlays to fund preclinical studies, manufacturing, and clinical research. The
transition will also increase the visibility of our lead therapeutic programs and the potential
impact on the stock price of news releases relating to these programs.
We, and our partner, Edwards Lifesciences, have initiated Phase 1 clinical trials in our respective
lead ZFP Therapeutic programs, and ZFP Therapeutics have never before been tested in humans. We
have completed enrollment and treatment of the patients in the first of these trials of SB-509 for
diabetic neuropathy and thus far have not observed any drug-related adverse events. However if our
lead ZFP Therapeutic fails its initial safety study, it could reduce our ability to attract new
investors and corporate partners. In January 2005, Sangamo filed an IND with the FDA for SB-509, a
ZFP TF activator of VEGF-A, for the treatment of mild to moderate diabetic neuropathy. We have
completed enrollment and treatment of a Phase 1, single blind, dose-escalation trial to measure the
laboratory and clinical safety of SB-509 and reported that we did not observe dose-limiting
toxicity or any severe adverse drug-related events. We presented in April 2006 safety data and
preliminary findings from our Phase 1 clinical trial and expect to initiate a Phase 2 clinical
trial of SB-509 in the second half of 2006. Edwards Lifesciences also filed an investigational new
drug (IND) application with the U.S. Food and Drug Administration (FDA) on February 10, 2004 and
initiated a Phase 1 clinical trial in humans in August, 2004 and a second in the first half of
2005. The first Phase 1 studies of a ZFP Therapeutic will be a highly visible test of the Companys
ZFP Therapeutic approach. Since we have increased our focus on ZFP Therapeutic research and
development, investors will increasingly assess the value of the Companys technology based on the
continued progress of ZFP Therapeutic products into and through clinical trials. If the initial
safety study of our lead therapeutic was halted due to safety concerns, this would negatively
affect the value of the Companys stock.
20
We are conducting proprietary research to discover ZFP Therapeutic product candidates. These
programs increase our financial risk of product failure, will significantly increase our research
expenditures, and may involve conflicts with our collaborators and strategic partners. Our
proprietary research programs consist of research which is funded solely by the Company and where
the Company retains exclusive rights to therapeutic products generated by the research. This is in
contrast to certain of our research programs that may be funded by corporate partners and in which
we may share rights to any resulting products. We have conducted proprietary research since
inception, however, we are placing greater emphasis on proprietary research and therapeutic
development and we expect this trend will continue in 2006 as we initiate our first Phase 2
clinical trial and bring new ZFP Therapeutics into clinical trials. Conducting proprietary research
programs may not generate corresponding revenue and may create conflicts with our collaborators or
strategic partners. The implementation of this strategy will involve substantially greater business
risks, the expenditure of significantly greater funds than our historic research activities and
will require substantial commitments of time from our management and staff.
In addition, disagreements with our collaborators or strategic partners could develop over rights
to our intellectual property with respect to our proprietary research activities. Any conflict with
our collaborators or strategic partners could reduce our ability to enter into future collaboration
or strategic partnering agreements and negatively impact our relationship with existing
collaborators and strategic partners, which could reduce our revenue and delay or terminate our
product development.
If conflicts arise between us and our collaborators, strategic partners, scientific advisors, or
directors, these parties may act in their self-interest, which may limit our ability to implement
our strategies. If conflicts arise between our corporate or academic collaborators, strategic
partners, or scientific advisors or directors and us, the other party may act in its self-interest,
which may limit our ability to implement our strategies. Our license agreement with Edwards
Lifesciences provides Edwards with worldwide, exclusive rights for ZFP Therapeutics for the
activation of VEGF and VEGF receptors for the treatment and prevention of ischemic cardiovascular
and vascular disease in humans. We have retained all rights to use our technology for all
therapeutic applications of VEGF activation outside of the treatment and prevention of ischemic
cardiovascular and vascular disease in humans. During the first quarter of 2005, Sangamo commenced
a Phase 1 clinical trial for the treatment of diabetic neuropathy using a ZFP Therapeutic for the
activation of VEGF. Edwards has stated that its rights include diabetic neuropathy and consequently
our activities relating to diabetic neuropathy constitute a breach of the agreement. We strongly
disagree with the Edwards assertion because diabetic neuropathy is a neurological disease and not
an ischemic vascular disease and therefore is outside the scope of the Edwards license. Sangamo and
Edwards are in discussions regarding this issue. Some of our academic collaborators and strategic
partners are conducting multiple product development efforts within each area that is the subject
of the collaboration with us. Our collaborators or strategic partners, however, may develop, either
alone or with others, products in related fields that are competitive with the products or
potential products that are the subject of these collaborations. Competing products, either
developed by the collaborators or strategic partners or to which the collaborators or strategic
partners have rights, may result in the withdrawal of partner support for our product candidates.
Some of our collaborators or strategic partners could also become competitors in the future. Our
collaborators or strategic partners could develop competing products, preclude us from entering
into collaborations with their competitors, fail to obtain timely regulatory approvals, terminate
their agreements with us prematurely, or fail to devote sufficient resources to the development and
commercialization of products. Any of these developments could harm our product development
efforts.
Our collaborators may control aspects of our clinical trials, which could result in delays and
other obstacles in the commercialization of our proposed products. For some programs we are
dependent on third party collaborators to design and conduct our clinical trials. As a result, we
may not be able to conduct these programs in the manner or on the time schedule we currently
contemplate. In addition, if any of these collaborative partners withdraw support for our programs
or proposed products or otherwise impair their development, our business could be negatively
affected.
We have limited experience in conducting clinical trials, and we may encounter unanticipated
toxicity or adverse events or fail to demonstrate the efficacy, causing us to delay, suspend or
terminate the development of our ZFP Therapeutics. Our ZFP Therapeutics may fail to show the
desired safety and efficacy in initial clinical trials. Even if we successfully complete Phase 1
trials, the FDA will require additional Phase 2 and Phase 3 clinical testing which involves
significantly greater resources, commitments and expertise that may require us to enter into a
collaborative relationship with a pharmaceutical company that would assume responsibility for
late-stage development and commercialization.
Our potential therapeutic products are subject to a lengthy and uncertain regulatory process, and
we may encounter unanticipated toxicity or adverse events or fail to demonstrate efficacy, causing
us to delay, suspend or terminate the development of a ZFP
21
Therapeutics and if these potential products are not approved, we will not be able to commercialize
those products. The FDA must approve any human therapeutic products before they can be marketed in
the United States. The process for receiving regulatory approval is long and uncertain, and a
potential product may not withstand the rigors of testing under the regulatory approval processes.
Before commencing clinical trials in humans, we or our commercial partner must submit an
Investigational New Drug (IND) application to the FDA. The FDA has 30 days to comment on the IND.
If the FDA does not comment on the IND, we or our commercial partner may begin clinical trials.
Clinical trials are subject to oversight by institutional review boards and the FDA. In addition,
our proposed clinical studies will require review from the Recombinant DNA Advisory Committee, or
RAC, which is the advisory board to the National Institutes of Health, or NIH, focusing on clinical
trials involving gene transfer. We will typically submit a proposed clinical protocol and other
product-related information to the RAC three to six months prior to the expected IND filing date.
Clinical trials:
|
|
|
must be conducted in conformance with the FDAs good clinical practices ICH guidelines and
other applicable regulations; |
|
|
|
|
must meet requirements for institutional review board oversight; |
|
|
|
|
must follow Institutional Biosafety Committee (IBC) and NIH RAC guidelines where
applicable; |
|
|
|
|
must meet requirements for informed consent; |
|
|
|
|
are subject to continuing FDA oversight; |
|
|
|
|
may require large numbers of test subjects; and |
|
|
|
|
may be suspended by our commercial partner, the FDA, or us at any time if it is believed
that the subjects participating in these trials are being exposed to unacceptable health risks or
if the FDA finds deficiencies in the IND or the conduct of these trials. |
Clinical trials are lengthy and are typically conducted in three sequential phases, but the phases
may overlap or be combined. Each trial must be reviewed and approved by an independent ethics
committee or institutional review board before it can begin. Phase 1 usually involves the initial
introduction of the investigational drug into healthy volunteers or patients to evaluate certain
factors, including its safety, dosage tolerance and, if possible, to gain an early indication of
its effectiveness. Phase 2 usually involves trials in a limited patient population to evaluate
dosage tolerance and appropriate dosage, identify possible adverse effects and safety risks, and
evaluate preliminarily the efficacy of the drug for specific indications. Phase 3 trials usually
further evaluate clinical efficacy and test further for safety by using the drug in its final form
in an expanded patient population. Later clinical trials may fail to support the findings of
earlier trials, which would delay, limit or prevent regulatory approvals.
While we have stated our intention to file an additional IND applications during the next several
years, this is only a statement of intent, and we may not be able to do so because the associated
product candidates may not meet the necessary preclinical requirements. In addition, there can be
no assurance that, once filed, an IND application will result in the actual initiation of clinical
trials.
We may not be able to find acceptable patients or may experience delays in enrolling patients for
our clinical trials. The FDA or we may suspend our clinical trials at any time if either believes
that we are exposing the subjects participating in these trials to unacceptable health risks. The
FDA or institutional review boards and/or institutional biosafety committees at the medical
institutions and healthcare facilities where we sponsor clinical trials may suspend any trial
indefinitely if they find deficiencies in the conduct of these trials. The FDA and institutional
review boards may also require large numbers of patients, and the FDA may require that we repeat a
clinical trial.
22
The results of early Phase 1 trials are based on a small number of patients over a short period of
time, and our success may not be indicative of results in a large number of patients or of
long-term efficacy. The results in early phases of clinical testing are based upon limited numbers
of patients and a limited follow-up period. For example, the initial results from the Phase 1
clinical trial of our ZFP Therapeutic, SB-509 product, we presented in April 2006. The primary end
point of the trial is clinical and laboratory safety, however we also collected some preliminary
efficacy data. Typically, our Phase 1 clinical trials for indications of safety enroll less than 50
patients. We anticipate that our Phase 2 clinical trials for efficacy would typically enroll
approximately 100 patients. Actual results with more data points may not confirm favorable results
from our earlier stage trials. A number of companies in the pharmaceutical and biotechnology
industries have suffered significant setbacks in late stage clinical trials even after achieving
promising results in earlier stage clinical trials. In addition, we do not yet know if early
results will have a lasting effect. If a larger population of patients does not experience positive
results, or if these results do not have a lasting effect, our products may not receive approval
from the FDA. Failure to demonstrate the safety and effectiveness of our gene based products in
larger patient populations could have a material adverse effect on our business that would cause
our stock price to decline significantly.
We cannot predict whether or when we will obtain regulatory approval to commercialize our product
candidates, therefore we cannot predict the timing of any future revenue from these product
candidates. We cannot commercialize any of our product candidates to generate revenue until the
appropriate regulatory authorities have reviewed and approved the applications for the product
candidates. We cannot assure you that the regulatory agencies will complete their review processes
in a timely manner or that we will obtain regulatory approval for any product candidate that we, or
our collaborators, develop. Satisfaction of regulatory requirements typically takes many years, is
dependent upon the type, complexity and novelty of the product and requires the expenditure of
substantial resources. Regulatory approval processes outside the United States include all of the
risks associated with the FDA approval process. In addition, we may experience delays or rejections
based upon additional government regulation from future legislation or administrative action or
changes in FDA policy during the period of product development, clinical trials and FDA regulatory
review.
Our gene regulation and gene modification technology is relatively new, and if we are unable to use
this technology in all our intended applications, it would limit our revenue opportunities. Our
technology involves a relatively new approach to gene regulation and gene modification. Although we
have generated ZFP TFs for hundreds of gene sequences, we have not created ZFP TFs for all gene
sequences and may not be able do so, which could limit the usefulness of our technology. In
addition, while we have demonstrated the function of engineered ZFP TFs in mammalian cell culture,
yeast, insects, plants, and animals, we have not yet done so in humans, and the failure to do so
could restrict our ability to develop commercially viable products. If we, and our collaborators or
strategic partners, are unable to extend our results to new commercially important genes,
experimental animal models, and human clinical studies, we may be unable to use our technology in
all its intended applications. Also, delivery of ZFP TFs and ZFNs into cells and organisms,
including humans, in these and other environments is limited by a number of technical hurdles,
which we may be unable to surmount. This is a particular challenge for therapeutic applications of
our technology that will require the use of gene transfer systems that may not be effective for the
delivery of our ZFP TFs or ZFNs in a particular therapeutic application.
The expected value and utility of our ZFP TFs and ZFNs is in part based on our belief that the
targeted or specific regulation of gene expression and targeted gene modification may enable us to
develop a new therapeutic approach as well as to help scientists better understand the role of
human, animal, and other genes in disease and to aid their efforts in drug discovery and
development. We also believe that the regulation of gene expression and targeted gene insertion
will have utility in agricultural applications. There is only a limited understanding of the role
of specific genes in all these fields. Life sciences companies have developed or commercialized
only a few products in any of these fields based on results from genomic research or the ability to
regulate gene expression. We, our collaborators, or our strategic partners may not be able to use
our technology to identify and validate drug targets or to develop commercial products in the
intended markets.
We are currently engaged in the research and development of a new application of our technology
platform: ZFP-mediated gene modification using ZFNs to effect either gene correction or gene
disruption. Using this technique, Sangamo scientists have engineered ZFNs to cut DNA at a specific
site within a target gene, and to then to either correct the adjacent sequences with newly
synthesized DNA copied from an introduced DNA template, gene correction, or to rejoin the two ends
of the break which frequently results in the disruption of the genes function. In so doing, we are
attempting to correct an abnormal or disease-related mutation or DNA sequence or to disrupt a
gene that is involved in disease pathology. ZFP-mediated gene modification is at an early research
stage. Our scientists have shown ZFP-mediated gene modification to work in isolated cells; however,
a significant amount of additional research will be needed before this technique can be evaluated
in animals or plants and subsequently tested for applications in human healthcare and plant
agriculture.
23
We may be unable to license gene transfer technologies that we may need to commercialize our ZFP TF
technology. In order to regulate a gene in a cell, the ZFP TF or ZFN must be efficiently delivered
to the cell. We have licensed certain gene transfer technologies for use with our Enabling
Technologies, which are ZFP TFs and ZFNs used in pharmaceutical discovery research and protein
production. We are evaluating these systems and other technologies which may need to be used in the
delivery of ZFP TFs or ZFNs into cells for in vitro and in vivo applications, including ZFP
Therapeutics. However, we may not be able to license the gene transfer technologies required to
develop and commercialize our ZFP Therapeutics. We have not developed our own gene transfer
technologies, and we rely on our ability to enter into license agreements to provide us with rights
to the necessary gene transfer technology. The inability to obtain a license to use gene transfer
technologies with entities which own such technology on reasonable commercial terms, if at all,
could delay or prevent the preclinical evaluation, clinical testing, and/or commercialization of
our therapeutic product candidates.
We do not currently have the infrastructure or capability to manufacture therapeutic products on a
commercial scale. In order for us to commercialize these products directly, we would need to
develop, or obtain through outsourcing arrangements, the capability to execute all of these
functions. If we are unable to develop or otherwise obtain the requisite preclinical, clinical,
regulatory, manufacturing, marketing, and sales capabilities, we would be unable to directly
commercialize our therapeutics products which would limit our future growth.
Even if our technology proves to be effective, it still may not lead to commercially viable
products. Even if our collaborators or strategic partners are successful in using our ZFP
technology in drug discovery, protein production, therapeutic development, or plant agriculture,
they may not be able to commercialize the resulting products or may decide to use other methods
competitive with our technology. To date, no company has received marketing approval or has
developed or commercialized any therapeutic or agricultural products based on our technology. The
failure of our technology to provide safe, effective, useful, or commercially viable approaches to
the discovery and development of these products would significantly limit our business and future
growth and would adversely affect our value.
Even if our product development efforts are successful and even if the requisite regulatory
approvals are obtained, our ZFP Therapeutics may not gain market acceptance among physicians,
patients, healthcare payers and the medical community. A number of additional factors may limit
the market acceptance of products including the following:
|
|
|
likelihood and rate of adoption by healthcare practitioners; |
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|
|
likelihood and rate of a products acceptance by the target population; |
|
|
|
|
timing of market entry relative to competitive products; |
|
|
|
|
availability of alternative therapies; |
|
|
|
|
price of our product relative to alternative therapies; |
|
|
|
|
availability of third-party reimbursement; |
|
|
|
|
extent of marketing efforts by us and third-party distributors or agents retained by us;
and |
|
|
|
|
side effects or unfavorable publicity concerning our products or similar products. |
Adverse events in the field of gene therapy may negatively impact regulatory approval or public
perception of our potential products. Our potential therapeutic products are delivered to patients
as gene-based drugs, or gene therapy. The clinical and commercial success of our potential products
will depend in part on public acceptance of the use of gene therapy for the prevention or treatment
of human diseases. Public attitudes may be influenced by claims that gene therapy is unsafe, and,
consequently, our products may not gain the acceptance of the public or the medical community.
Negative public reaction to gene therapy in general could result in greater government regulation
and stricter labeling requirements of gene therapy products, including any of our products, and
could cause a decrease in the demand for any products we may develop.
24
Our stock price is also influenced by public perception. Reports of serious adverse events in a
retroviral gene transfer trial for infants with X-linked severe combined immunodeficiency (X-linked
SCID) in France and subsequent FDA actions putting related trials on hold in the United States had
a significant negative impact on the public perception and stock price of certain companies
involved in gene therapy. Stock prices of these companies declined whether or not the specific
company was involved with retroviral gene transfer for the treatment of infants with SCID, or
whether the specific companys clinical trials were placed on hold in connection with these events.
Other potential adverse events in the field of gene therapy may occur in the future that could
result in greater governmental regulation of our potential products and potential regulatory delays
relating to the testing or approval of our potential products.
We are at the development phase of operations and may not succeed or become profitable. We began
operations in 1995 and are in the early phases of ZFP Therapeutic product development. We have
incurred significant losses and our net losses to date and our revenues have been generated from
Enabling Technology collaborations, strategic partners, and federal government research grants. In
2005, we have placed more emphasis on higher-value therapeutic product development and related
strategic partnerships. This shift in emphasis has the potential to increase the return on
investment to our stockholders by allocating capital resources to higher value, therapeutic product
development activities. At the same time, it increases our financial risk by increasing expenses
associated with product development. In addition, the preclinical or clinical failure of any single
product may have a significant effect on the actual or perceived value of our shares. Our business
is subject to all of the risks inherent in the development of a new technology, which include the
need to:
|
|
|
attract and retain qualified scientific and technical staff and management, particularly
scientific staff with expertise to develop our early-stage technology into therapeutic
products; |
|
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obtain sufficient capital to support the expense of developing our technology platform and
developing, testing, and commercializing products; |
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develop a market for our products; |
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successfully transition from a company with a research focus to a company capable of
supporting commercial activities; and |
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attract and enter into research collaborations with research and academic institutions and
scientists. |
Commercialization of our technologies will depend, in part, on strategic partnering with other
companies. If we are not able to find strategic partners in the future or our strategic partners do
not diligently pursue product development efforts, we may not be able to develop our technologies
or products, which could slow our growth and decrease our value. We expect to rely, to some
extent, on our strategic partners to provide funding in support of our research and to perform
independent research and preclinical and clinical testing. Our technology is broad based, and we do
not currently possess the resources necessary to fully develop and commercialize potential products
that may result from our technologies or the resources or capabilities to complete the lengthy
marketing approval processes that may be required for the products. Therefore, we plan to rely on
strategic partnerships to help us develop and commercialize ZFP Therapeutic products. If those
partners are unable or unwilling to advance our programs, or if they do not diligently pursue
product approval, this may slow our progress and defer our revenues. Our partners may sublicense or
abandon development programs or we may have disagreements with our partners, which would cause
associated product development to slow or cease. There can be no assurance that we will be able to
establish additional strategic collaborations for ZFP Therapeutic product development. We may
require significant time to secure additional collaborations or strategic partners because we need
to effectively market the benefits of our technology to these future collaborators and strategic
partners, which use the time and efforts of research and development personnel and our management.
Further, each collaboration or strategic partnering arrangement will involve the negotiation of
terms that may be unique to each collaborator or strategic partner. These business development
efforts may not result in a collaboration or strategic partnership.
The loss of our current or any future strategic partnering agreements would not only delay or
terminate the potential development or commercialization of products we may derive from our
technologies, but it may also delay or terminate our ability to test ZFP TFs for specific genes. If
any strategic partner fails to conduct the collaborative activities successfully and in a timely
manner, the preclinical or clinical development or commercialization of the affected product
candidates or research programs could be delayed or terminated.
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Our existing strategic partnering agreements are based on the achievement of milestones. Under the
strategic partnering agreements, we expect to receive revenue for the research and development of a
ZFP Therapeutic product and based on achievement of specific milestones. Achieving these milestones
will depend, in part, on the efforts of our strategic partner as well as our own. In contrast, our
historic Enabling Technology collaborations only pay us to supply ZFP TFs for the collaborators
independent use, rather than for future results of the collaborators efforts. If we, or any
strategic partner, fail to meet specific milestones, then the strategic partnership may be
terminated, which could decrease our revenues.
If our competitors develop, acquire, or market technologies or products that are more effective
than ours, this would reduce or eliminate our commercial opportunity. Any products that we or our
collaborators or strategic partners develop by using our ZFP technology platform will enter into
highly competitive markets. Even if we are able to generate ZFP Therapeutics that are safe and
effective for their intended use, competing technologies may prove to be more effective or less
expensive, which, to the extent these competing technologies achieve market acceptance, will limit
our revenue opportunities. In some cases, competing technologies have proven to be satisfactorily
effective and less expensive, as has been the case with technologies competitive with our Enabling
Technology(R). The effectiveness of these competing products has reduced the revenues generated by
our Enabling Technology. Competing technologies may include other methods of regulating gene
expression or modifying genes. ZFP TFs and ZFNs have broad application in the life sciences and
compete with a broad array of new technologies and approaches being applied to genetic research by
many companies. Competing proprietary technologies with our product development focus include:
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small molecule drugs; |
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monoclonal antibodies; |
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recombinant proteins; |
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gene therapy / cDNAs; |
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antisense; and |
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siRNA approaches |
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For our Enabling Technology Applications: |
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For protein production: gene amplification, meganucleases, insulator technology; |
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For target validation: antisense, siRNA; and |
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For plant agriculture: recombination approaches, mutagenesis approaches, meganucleases; |
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In addition to possessing competing technologies, our competitors include biotechnology
companies with: |
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substantially greater capital resources than ours; |
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larger research and development staffs and facilities than ours; and |
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greater experience in product development and in obtaining regulatory approvals and patent
protection; |
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These organizations also compete with us to: |
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attract qualified personnel; |
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attract parties for acquisitions, joint ventures or other collaborations; and |
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license the proprietary technologies of academic and research institutions
that are competitive with our technology, which may preclude us from pursuing similar
opportunities. |
Accordingly, our competitors may succeed in obtaining patent protection or commercializing products
before us. In addition, any products that we develop may compete with existing products or services
that are well established in the marketplace.
Our collaborators or strategic partners may decide to adopt alternative technologies or may be
unable to develop commercially viable products with our technology, which would negatively impact
our revenues and our strategy to develop these products. Our collaborators or strategic partners
may adopt alternative technologies, which could decrease the marketability of ZFP technology.
Additionally, because many of our collaborators or strategic partners are likely to be working on
more than one development project, they could choose to shift their resources to projects other
than those they are working on with us. If they do so, that would delay our ability to test our
technology and would delay or terminate the development of potential products based on our ZFP
technology. Further, our collaborators and strategic partners may elect not to develop products
arising out of our collaborative and strategic partnering arrangements or to devote sufficient
resources to the development, manufacturing, marketing, or sale of these products. If any of these
events occur, we may not be able to develop our technologies or commercialize our products.
We anticipate continuing to incur operating losses for the next several years. If material losses
continue for a significant period, we may be unable to continue our operations. We have generated
operating losses since we began operations in 1995. The extent of our future losses and the timing
of profitability are uncertain, and we expect to incur losses for the foreseeable future. We have
been engaged in developing our ZFP TF technology since inception, which has and will continue to
require significant research and development expenditures. In November 2005 we announced that we
had completed a registered direct offering to institutional and strategic investors for a total of
5,080,000 shares of common stock at a price of $3.85 per share to the investors, resulting in net
proceeds to Sangamo of approximately $18.2 million. To date, we have generated all other revenue
from Enabling Technology collaborations, strategic partnering agreements, and federal government
research grants. As of March 31, 2006, we had an accumulated deficit of approximately $113.2
million. We expect to incur losses for the foreseeable future. These losses will increase as we
expand and extend our research and development activities into human therapeutic product
development. If the time required to generate significant product revenues and achieve
profitability is longer than we currently anticipate, we may not be able to sustain our operations.
We may be unable to raise additional capital, which would harm our ability to develop our
technology and products. We have incurred significant operating losses and negative operating cash
flows since inception and have not achieved profitability. We expect capital outlays and operating
expenditures to increase over the next several years as we expand our infrastructure and research
and ZFP Therapeutic product development activities. While we believe our financial resources will
be adequate to sustain our current operations at least through 2007, we may seek additional sources
of capital through equity or debt financing. In addition, as we focus our efforts on proprietary
human therapeutics, we will need to seek FDA approval of potential products, a process that could
cost in excess of $100 million per product. We cannot be certain that we will be able to obtain
financing on terms acceptable to us, or at all. If adequate funds are not available, our business
and our ability to develop our technology and ZFP Therapeutic products would be harmed.
Our stock price has been volatile and may continue to be volatile, which could result in
substantial losses for investors. During the quarter ended March 31, 2006, our stock price range
from a low of $4.10 to high of $6.69. During the past two years, our common stock price has
fluctuated significantly, ranging from a low of $3.46 to a high of $6.49 during the year ended
December 31, 2005, and a low of $3.00 to a high of $8.02 during the year ended December 31, 2004.
Volatility in our common stock could cause stockholders to incur substantial losses. An active
public market for our common stock may not be sustained, and the market price of our common stock
may continue to be highly volatile. The market price of our common stock has fluctuated
significantly in response to the following factors, some of which are beyond our control:
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announcements by us or our partners providing updates on the progress or development
status of ZFP Therapeutics; |
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changes in market valuations of similar companies; |
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deviations in our results of operations from the guidance given by us or estimates of
securities analysts; |
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announcements by us or our competitors of new or enhanced products, technologies or
services or significant contracts, acquisitions, strategic relationships, joint ventures or
capital commitments; |
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regulatory developments; |
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additions or departures of key personnel; |
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future sales of our common stock or other securities by the company, management or
directors, liquidation of institutional funds that comprised large holdings of Sangamo stock;
and |
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decreases in our cash balances. |
Our common stock is thinly traded, which means large transactions in our common stock may be
difficult to conduct in a short time frame. We have a low volume of daily trades in our common
stock on the Nasdaq National Market. For example, the average daily trading volume in our common
stock on the Nasdaq National Market over the ten-day trading period prior to February 1, 2006 was
approximately 101,000 shares per day. Any large transactions in our common stock may be difficult
to conduct and may cause significant fluctuations in the price of our common stock.
Failure to attract, retain, and motivate skilled personnel and cultivate key academic
collaborations will delay our product development programs and our research and development
efforts. We are a small company with 68 full-time employees as of May 8, 2006 and our success
depends on our continued ability to attract, retain, and motivate highly qualified management and
scientific personnel and our ability to develop and maintain important relationships with leading
research and academic institutions and scientists. Competition for personnel and academic and other
research collaborations is intense. The success of our technology development programs depends on
our ability to attract and retain highly trained personnel and we have experienced a rate of
employee turnover that we believe is typical of emerging biotechnology companies. If we lose the
services of personnel with the necessary skills, it could significantly impede the achievement of
our research and development objectives. We are not presently aware of any plans of specific
employees to retire or otherwise leave the company. If we fail to negotiate additional acceptable
collaborations with academic and other research institutions and scientists, or if our existing
collaborations are unsuccessful, our ZFP Therapeutic development programs may be delayed or may not
succeed.
Because it is difficult and costly to protect our proprietary rights, and third parties have filed
patent applications that are similar to ours, we cannot ensure the proprietary protection of our
technologies and products. Our commercial success will depend in part on obtaining patent
protection of our technology and successfully defending any of our patents which may be challenged.
The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and can
involve complex legal and factual questions. No consistent policy regarding the breadth of claims
allowed in biotechnology patents has emerged to date. Accordingly, we cannot predict the breadth of
claims allowed in patents we own or license.
We are a party to various license agreements that give us rights under specified patents and patent
applications. Our current licenses, as our future licenses frequently will, contain performance
obligations. If we fail to meet those obligations, the licenses could be terminated. If we are
unable to continue to license these technologies on commercially reasonable terms, or at all, we
may be forced to delay or terminate our product development and research activities.
With respect to our present and any future sublicenses, since our rights derive from those granted
to our sublicensor, we are subject to the risk that our sublicensor may fail to perform its
obligations under the master license or fail to inform us of useful improvements in, or additions
to, the underlying intellectual property owned by the original licensor.
We are unable to exercise the same degree of control over intellectual property that we license
from third parties as we exercise over our internally developed intellectual property. We do not
control the prosecution of certain of the patent applications that we license from third parties;
therefore, the patent applications may not be prosecuted exactly as we desire or in a timely
manner.
The degree of future protection for our proprietary rights is uncertain, and we cannot ensure that:
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we or our licensors were the first to make the inventions covered by each of our pending
patent applications; |
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we or our licensors were the first to file patent applications for these inventions; |
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the patents of others will not have an adverse effect on our ability to do business; |
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others will not independently develop similar or alternative technologies or reverse
engineer any of our products, processes or technologies; |
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any of our pending patent applications will result in issued patents; |
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any patents issued or licensed to us or our collaborators or strategic partners will
provide a basis for commercially viable products or will provide us with any competitive
advantages; |
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any patents issued or licensed to us will not be challenged and invalidated by third
parties; or |
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we will develop additional products, processes or technologies that are patentable. |
Others have filed and in the future are likely to file patent applications that are similar to
ours. We are aware that there are academic groups and other companies that are attempting to
develop technology that is based on the use of zinc finger and other DNA binding proteins, and that
these groups and companies have filed patent applications. Several patents have been issued,
although we have no current plans to use the associated inventions. If these or other patents
issue, it is possible that the holder of any patent or patents granted on these applications may
bring an infringement action against our collaborators, strategic partners, or us claiming damages
and seeking to enjoin commercial activities relating to the affected products and processes. The
costs of litigating the claim could be substantial. Moreover, we cannot predict whether we, our
collaborators, or strategic partners would prevail in any actions. In addition, if the relevant
patent claims were upheld as valid and enforceable and our products or processes were found to
infringe the patent or patents, we could be prevented from making, using, or selling the relevant
product or process unless we could obtain a license or were able to design around the patent
claims. We can give no assurance that such a license would be available on commercially reasonable
terms, or at all, or that we would be able to successfully design around the relevant patent
claims. There may be significant litigation in the genomics industry regarding patent and other
intellectual property rights, which could subject us to litigation. If we become involved in
litigation, it could consume a substantial portion of our managerial and financial resources.
We cannot guarantee that third parties will not challenge our intellectual property. One of our
licensed patents, European Patent No. 0 682 699, entitled Functional Domains in Flavobacterium
Okeanokoites Restriction Endonuclease was granted on May 7, 2003 and forms the basis of Regional
Phase patents in France, Germany, Great Britain, Ireland and Switzerland. The granted claims of the
patent cover technologies used in our programs in targeted recombination and gene correction. On
December 1, 2005 an interlocutory decision revoking this patent was issued by the European Patent
Office. We have appealed this decision. If our appeal is ultimately unsuccessful, our ability to
exclude potential competitors in the field of targeted recombination and gene correction in Europe
may be limited. These developments apply only to Europe and do not affect our ability to practice
our targeted recombination and gene correction programs in Europe. Moreover, we also hold licenses
to six US patents to the technology covered by the opposed European patent, and hold licenses to
related applications pending in Canada and Japan. Accordingly, any effects of the opposition, up to
and including invalidation of the European patent, would be restricted to Europe and would have
little, if any, material adverse effect on our business.
We rely on trade secrets to protect technology where we believe patent protection is not
appropriate or obtainable. Trade secrets, however, are difficult to protect. While we require
employees, academic collaborators, and consultants to enter into confidentiality agreements, we may
not be able to adequately protect our trade secrets or other proprietary information or enforce
these confidentiality agreements.
Our collaborators, strategic partners, and scientific advisors have rights to publish data and
information in which we may have rights. If we cannot maintain the confidentiality of our
technology and other confidential information in connection with our collaborations and strategic
partnerships, then we may not be able to receive patent protection or protect our proprietary
information.
Regulatory approval, if granted, may be limited to specific uses or geographic areas, which could
limit our ability to generate revenues. Regulatory approval will be limited to the indicated use
for which we can market a product. Further, once regulatory approval for a product is obtained, the
product and its manufacturer are subject to continual review. Discovery of previously unknown
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problems with a product or manufacturer may result in restrictions on the product, manufacturer,
and manufacturing facility, including withdrawal of the product from the market. In Japan and
Europe, regulatory agencies also set or approve prices.
Even if regulatory clearance of a product is granted, this clearance is limited to those specific
states and conditions for which the product is useful, as demonstrated through clinical trials. We
cannot ensure that any ZFP Therapeutic product developed by us, alone or with others, will prove to
be safe and effective in clinical trials and will meet all of the applicable regulatory
requirements needed to receive marketing clearance in a given country.
Outside the United States, our ability to market a product is contingent upon receiving a marketing
authorization from the appropriate regulatory authorities, so we cannot predict whether or when we
would be permitted to commercialize our product. These foreign regulatory approval processes
include all of the risks associated with FDA clearance described above.
Our collaborations with outside scientists may be subject to change, which could limit our access
to their expertise. We work with scientific advisors and collaborators at academic research
institutions. These scientists are not our employees and may have other commitments that would
limit their availability to us. Although our scientific advisors generally agree not to do
competing work, if a conflict of interest between their work for us and their work for another
entity arises, we may lose their services. Although our scientific advisors and academic
collaborators sign agreements not to disclose our confidential information, it is possible that
some of our valuable proprietary knowledge may become publicly known through them.
Laws or public sentiment may limit the production of genetically modified agricultural products in
the future, and these laws could reduce our partners ability to sell these products. Genetically
modified products are currently subject to public debate and heightened regulatory scrutiny, either
of which could prevent or delay production of agricultural products. Effective as of October 1,
2005, we entered into a Research License and Commercial Option Agreement with Dow AgroSciences LLC
(DAS), a wholly owned indirect subsidiary of Dow Chemical Corporation. Under this agreement, we
will provide DAS with access to our proprietary ZFP technology and the exclusive right to use our
ZFP technology to modify the genomes or alter the nucleic acid or protein expression of plant
cells, plants, or plant cell cultures. The field-testing, production, and marketing of genetically
modified plants and plant products are subject to federal, state, local, and foreign governmental
regulation. Regulatory agencies administering existing or future regulations or legislation may not
allow production and marketing of our genetically modified products in a timely manner or under
technically or commercially feasible conditions. In addition, regulatory action or private
litigation could result in expenses, delays, or other impediments to our product development
programs or the commercialization of resulting products.
The FDA currently applies the same regulatory standards to foods developed through genetic
engineering as those applied to foods developed through traditional plant breeding. Genetically
engineered food products, however, will be subject to pre-market review if these products raise
safety questions or are deemed to be food additives. Governmental authorities could also, for
social or other purposes, limit the use of genetically modified products created with our gene
regulation technology.
Even if we are able to obtain regulatory approval for genetically modified products, our success
will also depend on public acceptance of the use of genetically modified products including drugs,
plants, and plant products. Claims that genetically modified products are unsafe for consumption or
pose a danger to the environment may influence public attitudes. Our genetically modified products
may not gain public acceptance. The subject of genetically modified organisms has received negative
publicity in the United States and particularly in Europe, and such publicity has aroused public
debate. The adverse publicity in Europe could lead to greater regulation and trade restrictions on
imports of genetically altered products. Similar adverse public reaction in the United States to
genetic research and its resulting products could result in greater domestic regulation and could
decrease the demand for our technology and products.
If we use biological and hazardous materials in a manner that causes injury or violates laws, we
may be liable for damages. Our research and development activities involve the controlled use of
potentially harmful biological materials as well as hazardous materials, chemicals, and various
radioactive compounds typically employed in molecular and cellular biology. We routinely use cells
in culture and gene delivery vectors, and we employ small amounts of radioisotopes in trace
experiments. Although we maintain up-to-date licensing and training programs, we cannot completely
eliminate the risk of accidental contamination or injury from the use, storage, handling, or
disposal of these materials. In the event of contamination or injury, we could be held liable for
damages that result, and any liability could exceed our resources. We currently carry insurance
covering claims arising from our use of these materials. However, if we are unable to maintain our
insurance coverage at a reasonable cost and with adequate coverage, our insurance may not cover any
liability that may arise. We are subject to federal, state, and local laws and regulations
governing the use,
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storage, handling, and disposal of these materials and specified waste products. To date, we have
not experienced significant costs in complying with regulations regarding the use of these
materials.
Anti-takeover provisions in our certificate of incorporation and Delaware law could make an
acquisition of the Company more difficult and could prevent attempts by our stockholders to remove
or replace current management. Anti-takeover provisions of Delaware law, our certificate of
incorporation and our bylaws and may discourage, delay or prevent a change in control of our
company, even if a change in control would be beneficial to our stockholders. In addition, these
provisions may frustrate or prevent any attempts by our stockholders to replace or remove our
current management by making it more difficult for stockholders to replace members of our board of
directors. In particular, under our certificate of incorporation our board of directors may issue
up to 5,000,000 shares of preferred stock with rights and privileges that might be senior to our
common stock, without the consent of the holders of the common stock. Moreover, without any further
vote or action on the part of the stockholders, the board of directors would have the authority to
determine the price, rights, preferences, privileges, and restrictions of the preferred stock. This
preferred stock, if it is ever issued, may have preference over, and harm the rights of, the
holders of common stock. Although the issuance of this preferred stock would provide us with
flexibility in connection with possible acquisitions and other corporate purposes, this issuance
may make it more difficult for a third party to acquire a majority of our outstanding voting stock.
Similarly, our authorized but unissued common stock is available for future issuance without
stockholder approval.
In addition, our certificate of incorporation:
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states that stockholders may not act by written consent but only at a stockholders
meeting; |
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establishes advance notice requirements for nominations for election to the board of
directors or proposing matters that can be acted upon at stockholders meetings; and |
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limits who may call a special meeting of stockholders. |
We are also subject to Section 203 of the Delaware General Corporation Law, which provides, subject
to certain exceptions, that if a person acquires 15% of our voting stock, the person is an
interested stockholder and may not engage in business combinations with us for a period of
three years from the time the person acquired 15% or more or our voting stock.
Insiders have substantial control over Sangamo and could delay or prevent a change in corporate
control. The interest of management could conflict with the interest of our other stockholders.
Our executive officers and directors beneficially own, in the aggregate, approximately 21% of our
outstanding common stock. As a result, these stockholders, if they choose to act together, will be
able to have a material impact on all matters requiring stockholder approval, including the
election of directors and approval of significant corporate transactions. This could have the
effect of delaying or preventing a change of control of Sangamo, which in turn could reduce the
market price of our stock.
Accounting pronouncements may affect our future financial position and results of operations On
January 1, 2006, we adopted Statement of Financial Accounting Standards No. 123 (revised 2004),
Share-Based Payment (or FAS 123R). As a result, we have included employee stock-based
compensation costs in our results of operations for the quarter ended March 31, 2006, as discussed
in Note 2, Employee Stock-Based Compensation, in the Notes to Condensed Consolidated Financial
Statements of Part I, Item I of this Form 10-Q. Our adoption of FAS 123R is expected to result in
compensation expense that will increase basic and diluted net loss
per share by approximately $0.08 per share for 2006. However, our estimate of future employee stock-based compensation expense is
affected by our stock price, the number of stock-based awards our board of directors may grant in
2006, as well as a number of complex and subjective valuation assumptions. These valuation
assumptions include, but are not limited to, the volatility of our stock price and employee stock
option exercise behaviors.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
The effective date of our first Registration Statement on Form S-1 filed under the Securities
Act of 1933, as amended, relating to the initial public offering of our common stock was April 6,
2000. On the same date, we signed an underwriting agreement with Lehman Brothers, Chase H&Q, ING
Barings LLC, and William Blair & Co., the managing underwriters for the initial public offering
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and the representatives of the underwriters named in the underwriting agreement, for the
initial public offering of 3,500,000 shares of our common stock at an initial public offering price
of $15 per share. The offering commenced on April 6, 2000 and was closed on April 11, 2000. The
initial public offering resulted in gross proceeds of $52.5 million. We received net proceeds of
$48.8 million after deducting underwriting discounts of $3.7 million. Expenses related to the
offering totaled approximately $1.4 million. None of Sangamos net proceeds from the initial public
offering were paid directly or indirectly to any director, officer, general partner of Sangamo or
their associates, persons owning 10% or more of any class of equity securities of Sangamo, or an
affiliate.
In November 2005 we announced that we had completed a registered direct offering to
institutional and strategic investors for a total of 5,080,000 shares of common stock at a price of
$3.85 per share to the investors, resulting in net proceeds to Sangamo of approximately $18.2
million.
From the time of receipt through March 31, 2006, Sangamo has used the net proceeds from its
initial public offering and register direct offering of common stock to invest in short-term and
long-term, interest bearing, investment-grade securities and has used its existing cash balances to
fund general operations. The proceeds are being used for general corporate purposes, including
working capital and product development. A portion of the net proceeds will also be used to acquire
or invest in complementary businesses or products or to obtain the right to use complementary
technologies. Sangamo has no agreements or commitments with respect to any such acquisition and is
not currently engaged in any material negotiations with respect to any such transaction.
ITEM 6. EXHIBITS
(a) Exhibits:
31.1 |
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Form of Rule 13a 14(a) Certification |
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31.2 |
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Form of Rule 13a 14(a) Certification |
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Certification Pursuant to 18 U.S.C. Section 1350. |
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SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
SANGAMO BIOSCIENCES, INC. Dated: May 9, 2006
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/s/ Greg S. Zante |
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Greg S. Zante |
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Senior Director, Finance and Administration |
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(Principal Financial and Accounting Officer) |
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