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):
October 29, 2008
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)
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| o |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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| o |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR
240.14d-2(b))
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| o |
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
October 29, 2008, Sangamo BioSciences, Inc. issued a press release announcing
its financial results for the quarter ended September 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 October 29, 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:
October 29, 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 THIRD QUARTER 2008
FINANCIAL
RESULTS
Richmond,
California
-
October 29, 2008 - Sangamo BioSciences, Inc. (Nasdaq: SGMO) today reported
third
quarter 2008 financial results and accomplishments.
For
the
third quarter ended September 30, 2008, Sangamo reported a consolidated net
loss
of $6.3 million, or $0.15 per share, compared to a net loss of $4.3 million,
or
$0.11 per share, for the same period in 2007. As of September 30, 2008, the
company had cash, cash equivalents and investments of $59.5 million. Subsequent
to the end of the quarter, the company received $8.5 million in scheduled
payments from collaborators.
Revenues
for the third quarter of 2008 were $3.7 million, compared to $2.3 million
for
the third quarter of 2007. Third 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 third quarter
of
2008 consisted of $3.2 million from collaboration agreements and $549,000
from
research grants.
Research
and development expenses were $7.6 million for the third quarter of 2008,
compared to $5.9 million for the same period in 2007. The increase in research
and development expenses for the third 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 stock-based compensation included in research and development expenses
totaled $580,000 and $364,000 in the third quarter of 2008 and 2007,
respectively.
General
and administrative expenses were $2.6 million for the third quarter of 2008,
compared to $1.7 million for the same period in 2007. The increase in general
and administrative expenses was primarily due to increased personnel costs,
including non-cash stock-based compensation which totaled $709,000 in the
third
quarter of 2008 compared to $202,000 in the same period in 2007.
Total
operating expenses for the third quarter of 2008 were $10.1 million, compared
to
$7.6 million for the same period in 2007.
Net
interest and other income was $42,000 for the third quarter of 2008, compared
to
$1.1 million for the same period in 2007. The decrease is due to lower average
investment balances and lower interest rates as well as a foreign currency
translation loss during the quarter.
Nine
Month
Results
For
the
nine months ended September 30, 2008, the consolidated net loss was $21.7
million, or $0.53 per share, compared to a net loss of $14.8 million, or
$0.41
per share, for the nine-month period ended September 30, 2007. Revenues were
$9.4 million for the first nine months of 2008, compared to $6.3 million
in the
same period in 2007. Total operating expenses were $32.5 million for the
first
nine months of 2008 and $23.5 million for the same period 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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Initiation
of a Phase 2 clinical trial (SB-509-801) to evaluate SB-509 in
subjects
with Amyotrophic Lateral Sclerosis (ALS). ALS
is a
progressive, degenerative motor-neuron disease for which there
are limited
treatment options and no cure. The Phase 2 trial is a randomized
repeat-dosing, open-label, multi-center study designed to evaluate
the
effect of intramuscular administration of SB-509 on the progression
of the
disease in subjects with ALS. In addition to gathering data on
safety and
tolerability of SB-509, the study will also evaluate stem cell
mobilization in subjects with ALS receiving SB-509.
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·
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Presentation
of additional data from Phase 1b study of SB-509 (SB-509-401) and
interim
data from Phase 2 study (SB-509-701) in subjects with diabetic
neuropathy
(DN).
Additional data from the Phase 1b clinical trial (SB-509-401) were
presented at the 44th Annual Meeting of the European Association
for the
Study of Diabetes (EASD), demonstrating a statistically significant
(p=0.0016) positive correlation of 2 or more response endpoints
in the
SB-509 treated group compared with placebo treated subjects at
day 180
post-treatment. Response endpoints were defined as greater than
a 14%
improvement in quantitative sensory testing (QST), greater than
0.8
meters/second (m/sec) improvement in NCV and greater than a 3 point
improvement as judged by the Neuropathy Impairment Scale - Lower
Limbs
(NIS-LL). The trial was conducted in subjects with mild to moderate
diabetic neuropathy over a six month period after a single administration
of SB-509. Positive interim clinical data were also presented at
the
International Society for Cellular Therapy (ISCT) Europe Regional
Meeting
in Antwerp, Belgium from the Phase 2 trial of SB-509 (SB-509-701)
conducted in subjects with moderate to severe DN who entered the
trial
with at least one “blocked nerve”. The data demonstrate recovery of
sensory nerve conduction velocity (NCV) in 75% of SB-509 treated
subjects
compared to 25% of placebo treated subjects. 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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Official
launch of Sigma-Aldrich CompoZrTM
platform of zinc finger nuclease (ZFN) reagents for
gene-editing.
In September, Sangamo’s partner, Sigma-Aldrich Corporation (Nasdaq: SIAL),
the exclusive distributor of ZFP products for research
applications, launched
sales of CompoZr ZFN reagents. The CompoZr ZFN platform of reagents
is
expected to provide researchers with the ability to target and
precisely
manipulate the genome of living cells, resulting in cell lines
or whole
organisms with defined gene deletions, insertions, or corrections.
Initially offered as a customized service for developing ZFNs for
specific
gene targets, the CompoZr ZFN platform will eventually include
ZFN-based
kits for targeted transgene insertion and a catalog of off-the-shelf
reagents for commonly studied gene targets, gene families, and
pathways. For
more information on Sigma-Aldrich's CompoZr zinc finger nuclease
technology platform, visit http://www.compozrzfn.com
or
contact a sales representative at zfn@sial.com
.
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Conference
Call
Sangamo
will host a conference call today, October 29, 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 877-857-6173 for domestic callers and
719-325-4835 for international callers. The passcode for the call is 1077974.
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 October 29, 2008 to midnight ET on November 5, 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 1077974.
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. Other therapeutic
development programs are focused on 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 Sangamo’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-
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SELECTED
FINANCIAL DATA
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(in
thousands, except per share data)
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|||||||||||||
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(unaudited)
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|||||||||||||
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Three
Months Ended
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Nine
Months Ended
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||||||||||||
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September
30,
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September
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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3,196
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$
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1,915
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$
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7,658
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$
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4,526
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|||||
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Research
grants
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549
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410
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1,694
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1,805
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|||||||||
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Total
revenues
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3,745
|
2,325
|
9,352
|
6,331
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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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7,563
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5,916
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24,492
|
17,655
|
|||||||||
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General
and administrative
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2,564
|
1,728
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8,036
|
5,840
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|||||||||
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Total
operating expenses
|
10,127
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7,644
|
32,528
|
23,495
|
|||||||||
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Loss
from operations
|
(6,382
|
)
|
(5,319
|
)
|
(23,176
|
)
|
(17,164
|
)
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|||||
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Interest
income, net
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42
|
1,051
|
1,448
|
2,356
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|||||||||
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Net
loss
|
$
|
(6,340
|
)
|
$
|
(4,268
|
)
|
$
|
(21,728
|
)
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$
|
(14,808
|
)
|
|
|
Basic
and diluted net loss per common share
|
$
|
(0.15
|
)
|
$
|
(0.11
|
)
|
$
|
(0.53
|
)
|
$
|
(0.41
|
)
|
|
|
Shares
used in computing basic and diluted net loss per common
share
|
40,928
|
38,925
|
40,759
|
36,387
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|||||||||
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CONDENSED
BALANCE SHEET DATA
|
|||||||||||||
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September
30, 2008
|
|
|
December
31, 2007
|
|
|||||||||
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Cash,
cash equivalents, and investments
|
$
|
59,458
|
$
|
81,412
|
|||||||||
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Total
assets
|
70,749
|
83,900
|
|||||||||||
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Total
stockholders' equity
|
56,021
|
72,122
|