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): July
23, 2008
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SANGAMO
BIOSCIENCES, INC.
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(Exact
Name of Registrant as Specified in Its
Charter)
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Delaware
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(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
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(Registrant’s
Telephone Number, Including Area
Code)
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(Former
Name or Former Address, if Changed Since Last
Report)
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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):
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o
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Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
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o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR
240.14d-2(b))
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o
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR
240.13e-4(c))
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Item
2.02. Results of Operations and Financial Condition.
On
July
23, 2008, Sangamo BioSciences, Inc. issued a press release announcing its
financial results for the quarter ended June 30, 2008. 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:
Exhibit
No.
| 99.1 |
Press
Release Issued July 23, 2008.
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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:
July 23, 2008
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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 Boulevard
Richmond,
CA 94804
510-970-6000
l
510-236-8951(Fax)
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SANGAMO
BIOSCIENCES REPORTS SECOND QUARTER 2008
FINANCIAL
RESULTS
Richmond,
California
- July
23, 2008 - Sangamo BioSciences, Inc. (Nasdaq: SGMO) today reported second
quarter 2008 financial results and accomplishments.
For
the
second quarter ended June 30, 2008, Sangamo reported a consolidated net loss
of
$7.4 million, or $0.18 per share, compared to a net loss of $5.2 million, or
$0.15 per share, for the same period in 2007. As of June 30, 2008, the company
had cash, cash equivalents and investments of $64.3 million.
Revenues
for the second quarter of 2008 were $2.8 million, compared to $2.6 million
for
the second quarter of 2007. Second quarter 2008 revenues were primarily
comprised of revenue recognition from the Company’s collaboration agreements
with Dow AgroSciences (DAS) and Sigma-Aldrich, enabling technology agreements
in
protein production and research grants. The revenue recognized for the second
quarter of 2008 consisted of $2.4 million in collaboration agreements and
$464,000 in research grants.
Research
and development expenses were $8.3 million for the second quarter of 2008,
compared to $6.3 million for the same period in 2007. The increase in research
and development expenses for the second quarter of 2008 was primarily due to
advancing the Company’s clinical development programs in diabetic neuropathy and
pre-IND programs to develop ZFP Therapeutics for the treatment of HIV/AIDS
and
glioblastoma, as well as increased research and development personnel costs.
Non-cash employee stock-based compensation included in research and development
expenses totaled $0.7 million and $0.3 million in the second quarter of 2008
and
2007, respectively.
General
and administrative expenses were $2.5 million for the second quarter of 2008,
compared to $2.1 million for the same period in 2007. The increase in general
and administrative expenses was primarily due to increased personnel costs,
including non-cash employee stock-based compensation which totaled $0.6 million
in the second quarter of 2008 compared to $0.2 million in the same period in
2007.
Total
operating expenses for the second quarter of 2008 were $10.8 million, compared
to $8.4 million for the same period in 2007.
Net
interest and other income was $570,000 for the second quarter of 2008, compared
to $657,000 for the same period in 2007.
Six
Month
Results
For
the
six months ended June 30, 2008, the consolidated net loss was $15.4 million,
or
$0.38 per share, compared to a net loss of $10.5 million, or $0.30 per share,
for the period ended June 30, 2007. Revenues were $5.6 million for the first
half of 2008, compared to $4.0 million in the same period in 2007. Total
operating expenses were $22.4 million for the first half of 2008 and $15.9
million in the first half of 2007. The increase in operating expenses for 2008
was primarily associated with Sangamo’s clinical development programs in
diabetic neuropathy and pre-IND programs to develop ZFP Therapeutics for the
treatment of HIV/AIDS and glioblastoma, as well as increased research and
development personnel costs and lab supply expenses.
Recent
Highlights
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·
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Dow
AgroSciences announces early exercise of commercial license for ZFP
technology.
Four months earlier than expected Dow AgroSciences (DAS) announced
during
the BIO International Convention in June that they had exercised
their
option, under and existing agreement with Sangamo, for a commercial
license to Sangamo’s zinc finger DNA-binding protein (ZFP) technology for
use in plant agriculture. DAS will use the technology to generate
products
itself and plans to sublicense the technology to other companies
under the
trademark of ExZact Precision TraitsTM.
As part of the agreement, Sangamo will receive a license fee payment
of
$6.0 million and the balance of the outstanding milestone payments
of
approximately $2.3 million. In addition, Sangamo is eligible to receive
development and commercial milestone payments and royalties on product
sales for any product that DAS develops, as well as 25% of any cash
consideration received by DAS under such sublicenses. A webcast replay
of
the press conference that DAS hosted is available on Sangamo’s website on
the Investor page under Events and Presentations.
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·
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Presentation
of complete 180 day follow-up data from Phase 1b study of SB-509
in
subjects with diabetic neuropathy (DN).
Data from the Phase 1b clinical trial were presented at the American
Diabetes Association Meeting in June. The data demonstrate statistically
significant improvement in quantitative sensory testing and Neuropathy
Impairment Score-Lower Limbs (NIS-LL), a quantitative measure of
the
neurologic exam, as well as clinically relevant trends toward improvement
in nerve conduction velocities. The trial was conducted in subjects
with
mild to moderate diabetic neuropathy over a six month period after
a
single administration of SB-509. SB-509 is an injectable formulation
of
plasmid DNA that encodes a ZFP transcription factor (ZFP TFTM),
designed to upregulate the vascular endothelial growth factor-A (VEGF-A)
gene.
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·
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Phase
2 clinical trial, SB-509-701 fully enrolled and
expanded.
A
Phase 2 study of SB-509 is being undertaken in subjects with moderate
to
severe diabetic neuropathy with at least one “blocked nerve”. In addition
to the announcement of the completion of accrual of the first part
of the
trial, Sangamo announced plans to expand and broaden the trial to
test an
additional dosing regimen.
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·
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Data
from critical limb ischemia Phase 1 trial presented at the International
Society for Cellular Therapy Meeting.
Sangamo’s collaborators from Duke University presented data from the
completed Phase 1 trial of the company’s ZFP TF activator of VEGF-A for
the treatment of critical limb ischemia. The data from this trial
demonstrated that administration of the ZFP transcription factor
resulted
in a statistically significant increase in circulating stem cells
in the
peripheral blood. In addition, within a subgroup in which bone marrow
cells were examined before and after treatment, the data suggests
that
subjects who showed the most marked clinical improvements, as judged
by
limb salvage, ulcer healing, reduction in pain and increased oxygen
concentrations in the tissues of the lower limbs, also showed the
greatest
increase in bone marrow stem cells. This observation of stem cell
mobilization after treatment with Sangamo’s ZFP TF activator of VEGF-A, is
being further investigated in an ongoing Phase 2 trial of SB-509,
SB-509-703.
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·
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Announcement
of research and license agreement with F. Hoffmann-La Roche Ltd.
and
Hoffmann-La Roche Inc. (Roche) for the use of ZFP technology to develop
transgenic animals.
In July, Sangamo and Sigma-Aldrich Corporation jointly announced
a
research and license agreement to provide Roche with non-exclusive,
worldwide rights for the use of Sangamo’s ZFP nuclease (ZFNTM)
technology to develop cell-lines and transgenic animals with targeted
modifications in a specified gene in a specified species. Roche also
has
an option for an exclusive, worldwide license from Sangamo for the
commercial use of such ZFN-generated transgenic animals in the production
of therapeutic and diagnostic
products.
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·
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Publication
of preclinical data in Nature
Biotechnology.
Papers highlighting therapeutic and research applications of Sangamo’s ZFN
technology were published in the scientific journal, Nature
Biotechnology.
The first paper demonstrated the use of ZFNs to efficiently generate
transgenic animals, in this case zebrafish, a widely recognized system
for
human disease modeling and in vivo drug discovery. A second publication
described the successful ZFN-mediated disruption of the CCR5 gene
in human
T-cells and the positive effects on HIV resistance and reduction
in viral
load in an animal model of HIV infection.
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Conference
Call
Sangamo
will host a conference call today, July 23, 2008 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 with respect to the remainder
of
2008.
The
conference call dial-in numbers are 877-627-6562 for domestic callers and
719-325-4874 for international callers. The passcode for the call is 8762164.
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 July 23, 2008 to midnight ET on July 30, 2008. 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
8762164.
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. Other therapeutic
development programs are focused on stem cell mobilization, ALS, cancer,
HIV/AIDS, 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
outside of the human therapeutic space including Dow AgroSciences, Sigma-Aldrich
Corporation and several companies applying its ZFP Technology to enhance the
production of protein pharmaceuticals. For more information about Sangamo,
visit
the company’s web site at www.sangamo.com.
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
and therapeutic 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, 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 ZFP-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 Sangamo’s Annual
Report 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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Six
Months Ended
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||||||||||
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June
30,
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June
30,
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||||||||
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2008
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2007
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2008
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2007
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|||||
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Consolidated
Statement of Operations Data:
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|||||||||||||
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Revenues
|
|||||||||||||
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Collaboration
agreements
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$
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2,378
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$
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1,461
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$
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4,462
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$
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2,611
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|||||
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Research
grants
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464
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1,123
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1,145
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1,395
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|||||||||
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Total
revenues
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2,842
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2,584
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5,607
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4,006
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|||||||||
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Operating
expenses:
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|||||||||||||
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Research
and development
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8,286
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6,309
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16,929
|
11,739
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|||||||||
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General
and administrative
|
2,545
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2,113
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5,472
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4,112
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|||||||||
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Total
operating expenses
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10,831
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8,422
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22,401
|
15,851
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|||||||||
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Loss
from operations
|
(7,989
|
)
|
(5,838
|
)
|
(16,794
|
)
|
(11,845
|
)
|
|||||
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Interest
income, net
|
570
|
657
|
1,406
|
1,305
|
|||||||||
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Net
loss
|
$
|
(7,419
|
)
|
$
|
(5,181
|
)
|
$
|
(15,388
|
)
|
$
|
(10,540
|
)
|
|
|
Basic
and diluted net loss per common share
|
$
|
(0.18
|
)
|
$
|
(0.15
|
)
|
$
|
(0.38
|
)
|
$
|
(0.30
|
)
|
|
|
Shares
used in computing basic and diluted net loss per common
share
|
40,858
|
35,136
|
40,673
|
35,097
|
|||||||||
|
|
|
|
|||||||||||
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CONSOLIDATED
CONDENSED BALANCE SHEET DATA
|
|
|
|||||||||||
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June
30, 2008
|
December
31, 2007
|
||||||||||||
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Cash,
cash equivalents, and investments
|
$
|
64,295
|
$
|
81,412
|
|||||||||
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Total
assets
|
75,934
|
83,900
|
|||||||||||
|
Total
stockholders' equity
|
60,613
|
72,122
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###