UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
8-K
CURRENT
REPORT PURSUANT
TO
SECTION 13 OR 15(D) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date of report (Date of earliest event
reported): April 29,
2009
SANGAMO
BIOSCIENCES, INC.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
(State or
Other Jurisdiction of Incorporation)
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000-30171
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68-0359556
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(Commission
File Number)
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(IRS
Employer Identification
No.)
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501
Canal Blvd, Suite A100
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Richmond,
California 94804
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(Address
of Principal Executive Offices)
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(Zip
Code)
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(510)
970-6000
(Registrant’s
Telephone Number, Including Area Code)
(Former
Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions (see General Instruction A.2.
below):
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item
2.02. Results of Operations and Financial Condition.
On
April 29, 2009, Sangamo BioSciences, Inc. issued a press release announcing its
financial results for the quarter ended March 31, 2009. A copy of the
press release is attached as Exhibit 99.1 to this Current Report on Form
8-K.
Item
9.01 Financial Statements and Exhibits
(c) Exhibits. The
following material is filed as an exhibit to this Current Report on Form
8-K:
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99.1
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Press
Release Issued April 29,
2009.
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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DATE:
April 29, 2009
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SANGAMO
BIOSCIENCES, INC.
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By:
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/s/
EDWARD O. LANPHIER II
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Edward
O. Lanphier II
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President,
Chief Executive Officer
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Sangamo
BioSciences, Inc.
Point
Richmond Tech Center
501
Canal Blvd.
Richmond,
CA 94804
510-970-6000
●
510-236-8951(Fax)
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SANGAMO
BIOSCIENCES REPORTS FIRST QUARTER 2009
FINANCIAL
RESULTS
Richmond, California – April
29, 2009 – Sangamo BioSciences, Inc. (Nasdaq: SGMO) today reported first quarter
2009 financial results and accomplishments.
For the
first quarter ended March 31, 2009, Sangamo reported a consolidated net loss of
$6.8 million, or $0.17 per share, compared to a net loss of $8.0 million, or
$0.20 per share, for the same period in 2008. As of March 31, 2009, the company
had cash and cash equivalents, marketable securities and interest receivable of
$57.9 million.
Revenues
for the first quarter of 2009 were $3.2 million, compared to $2.8 million for
the same period in 2008. First quarter 2009 revenues were primarily from
Sangamo’s agreements with Dow AgroSciences and Sigma-Aldrich Corporation and
enabling technology agreements.
Research
and development expenses were $7.3 million for the first quarter of 2009,
compared to $8.6 million for the same period in 2008. The decrease in research
and development expenses is primarily related to lower clinical trial expenses
in Sangamo’s ongoing SB-509 program in diabetic neuropathy, partially offset by
the ramp up for its Phase 1 clinical trial for HIV/AIDS, which opened in the
first quarter of 2009, and its planned Phase 1 clinical trial in glioblastoma
multiforme. Non-cash employee stock-based compensation included in research and
development expenses totaled $0.7 million and $0.9 million in the 2009 and 2008
periods, respectively.
General
and administrative expenses were $2.9 million for both the first quarter of 2009
and the corresponding 2008 period. Non-cash employee stock-based compensation
included in general and administrative expenses totaled $0.8 million and $0.9
million in the 2009 and 2008 periods, respectively.
Total
operating expenses for the first quarter of 2009 were $10.2 million, compared to
$11.6 million for the same period in 2008.
Net
interest and other income was $0.2 million for the first quarter of 2009,
compared to $0.8 million for the same period in 2008. The decrease
was due to lower average investment balances and lower interest
rates.
First
Quarter 2009 Highlights
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·
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Sangamo and its collaborators
at the University of Pennsylvania opened a Phase 1 clinical trial to
evaluate SB-728-T for the treatment of HIV/AIDS. The study is an
open-label Phase 1 clinical trial designed to evaluate the safety and
tolerability of a single infusion of SB-728-T, autologous (a patient’s
own) CD4+ T cells genetically modified at the CCR5 gene by CCR5-specific
zinc finger DNA-binding protein nucleases (ZFNs). A total of twelve
subjects with HIV will be enrolled in this trial in two treatment cohorts.
In an animal model of HIV infection, SB-728-T has been shown to lead to an
increase in CD4+ T-cell counts, a reduction in viral load and expansion of
CCR5-modified T-cells, suggesting resistance to HIV. CCR5 is a
co-receptor that enables HIV to enter and infect cells of the immune
system. Individuals carrying a natural mutation of their CCR5
gene, CCR5-delta32, are highly resistant to infection by
HIV. Brief exposure of cells to Sangamo’s ZFNs results in the
permanent disruption of the CCR5 gene. This trial is the first
zinc finger nuclease therapeutic study in humans. Individuals
interested in participating in this trial should visit http://www.clinicaltrials.gov/
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Sangamo
BioSciences, Inc.
Point
Richmond Tech Center
501
Canal Blvd.
Richmond,
CA 94804
510-970-6000 ●
510-236-8951(Fax)
|
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·
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Sangamo BioSciences, Inc. and
its plant agriculture partner Dow AgroSciences announce publication in
Nature of the successful application
of ZFP technology for the efficient generation of maize plants with
multiple, commercially important traits. In a study published in
the Advance Online edition of Nature, scientists at
Dow AgroSciences and Sangamo used ZFNs to introduce a herbicide tolerance
gene into a pre-determined address in the maize genome, simultaneously
eliminating the expression of an enzyme involved in the production of
phytate, a natural but undesirable compound found in feed crops and a
cause of environmental pollution. In a rapid, single step
process the gene involved in phytate production was disabled and
permanently linked with the acquisition of herbicide tolerance – i.e.
stacking the two desired characteristics in the plant and generating
reduced phytate, herbicide tolerant corn. This new method efficiently
targets specific genes, making it suitable for routine plant gene
modification. The paper can be accessed at
http://www.nature.com/nature/journal/vaop/ncurrent/index.html
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·
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Announcement of achievement of
a major production throughput milestone as part of its agreement with
Sigma-Aldrich Corporation in research reagents.
The milestone, which was achieved in December 2008, over a year ahead of
schedule, triggered a payment of $1.0 million to
Sangamo.
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Conference
Call
Sangamo
will host a conference call today at 5:00 p.m. ET, which will be open to the
public. The call will also be webcast live and can be accessed via a
link on the Sangamo BioSciences website in the Investor Relations section under
“Events and Presentations” http://investor.sangamo.com/events.cfm. The
webcast replay will also be available for two weeks after the call. During the
conference call, the company will review these results, discuss other business
matters, and provide forward-looking guidance.
The
conference call dial-in numbers are 877-340-7913 for domestic callers and
719-325-4907 for international callers. The passcode for the call is
5624956. For those unable to listen in at the designated time, a
conference call replay will be available for one week following the conference
call, from approximately 8:00 p.m. ET on April 29, 2009 to 11:59 p.m. ET on May
6, 2009. The conference call replay numbers for domestic and international
callers are 888-203-1112 and 719-457-0820 respectively. The conference ID number
for the replay is 5624956.
About
Sangamo
Sangamo
BioSciences, Inc. is focused on the research and development of novel
DNA-binding proteins for therapeutic gene regulation and
modification. The most advanced ZFP TherapeuticTM
development program is currently in Phase 2 clinical trials for
evaluation of safety and clinical effect in patients with diabetic neuropathy
and ALS. Sangamo also has a Phase 1 clinical trial to evaluate safety and
clinical effect of a ZFP Therapeutic for the treatment of HIV/AIDS. Other
therapeutic development programs are focused on cancer, neuropathic pain, nerve
regeneration, Parkinson’s disease and monogenic diseases. Sangamo’s
core competencies enable the engineering of a class of DNA-binding proteins
known as zinc finger DNA-binding proteins (ZFPs). By engineering ZFPs
that recognize a specific DNA sequence Sangamo has created ZFP transcription
factors (ZFP TFTM) that
can control gene expression and, consequently, cell function. Sangamo
is also developing sequence-specific ZFP Nucleases (ZFNTM) for
gene modification. Sangamo has established strategic partnerships
with companies in non-therapeutic applications of its technology including Dow
AgroSciences, Sigma-Aldrich Corporation and several companies applying its ZFP
technology to engineer cell lines for the production of protein pharmaceuticals.
For more information about Sangamo, visit the company’s web site at www.sangamo.com.
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Sangamo
BioSciences, Inc.
Point
Richmond Tech Center
501
Canal Blvd.
Richmond,
CA 94804
510-970-6000 ●
510-236-8951(Fax)
|
This
press release contains forward-looking statements regarding Sangamo’s current
expectations. These forward looking statements include, without
limitation, references to the research and development of ZFP TFs and ZFNs,
clinical trials, human therapeutic and plant applications of
Sangamo's ZFP technology platform, achievement of research milestones and
objectives, strategic partnership with collaborators and anticipated amount of
cash and cash equivalents. These statements are not guarantees of
future performance and are subject to certain risks, uncertainties and
assumptions that are difficult to predict. Factors that could cause actual
results to differ include, but are not limited to, uncertainties arising out of
the Company’s collaboration with Dow AgroSciences relating to plant agriculture,
the early stage of ZFP Therapeutic development, uncertainties related to the
timing of initiation and completion of clinical trials, whether clinical trial
results will validate and support the safety and efficacy of ZFP Therapeutics,
and the ability to establish strategic partnerships. Further, there
can be no assurance that the necessary regulatory approvals will be obtained or
that Sangamo will be able to develop commercially viable gene-based
therapeutics. Actual results may differ from those projected in forward-looking
statements due to risks and uncertainties that exist in the company’s operations
and business environments. These risks and uncertainties are described more
fully in the company’s’ Annual Reports on Form 10-K and Quarterly Reports on
Form 10-Q as filed with the Securities and Exchange Commission. Forward-looking
statements contained in this announcement are made as of this date and will not
be updated.
Contact
Sangamo BioSciences,
Inc.
Elizabeth
Wolffe, Ph.D.
510-970-6000,
x271
-more-
SELECTED
FINANCIAL DATA
(in
thousands, except per share data)
(unaudited)
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Three
Months Ended
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March
31,
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2009
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2008
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Consolidated
Statement of Operations Data:
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Revenues
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||||||||
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Collaboration
agreements
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$ | 3,157 | $ | 2,084 | ||||
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Research
grants
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- | 681 | ||||||
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Total
revenues
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3,157 | 2,765 | ||||||
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Operating
expenses:
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||||||||
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Research
and development
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7,256 | 8,646 | ||||||
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General
and administrative
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2,926 | 2,927 | ||||||
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Total
operating expenses
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10,182 | 11,573 | ||||||
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Loss
from operations
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(7,025 | ) | (8,808 | ) | ||||
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Interest
and other income, net
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193 | 836 | ||||||
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Net
loss
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$ | (6,832 | ) | $ | (7,972 | ) | ||
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Basic
and diluted net loss per common share
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$ | (0.17 | ) | $ | (0.20 | ) | ||
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Shares
used in computing basic and diluted net loss per common
share
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41,066 | 40,489 | ||||||
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March 31, 2009
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December 31, 2008
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(Unaudited)
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CONSOLIDATED
CONDENSED BALANCE SHEET DATA
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Cash
and cash equivalents, marketable securities and interest
receivable
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$ | 57,866 | $ | 65,025 | ||||
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Total
assets
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60,878 | 67,850 | ||||||
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Total
stockholders' equity
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49,991 | 55,396 | ||||||
###