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):
February 5, 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)
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
February 5, 2008, Sangamo BioSciences, Inc. issued a press release announcing
its financial results for the quarter and year ended December 31, 2007. 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 February 5, 2008.
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:
February 5, 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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TO
BUSINESS, HEALTH AND TECHNOLOGY EDITORS:
Sangamo
BioSciences Reports 2007 Fourth Quarter and Year-End Financial
Results
Company
Ends Year with Cash and Investments of $81.4 Million
RICHMOND,
Calif., Feb. 5 /PRNewswire-FirstCall/ -- Sangamo BioSciences, Inc. (Nasdaq:
SGMO) today reported 2007 fourth quarter and year-end financial results and
accomplishments and provided an outlook for 2008.
For
the
fourth quarter ended December 31, 2007, Sangamo reported a consolidated net
loss
of $6.7 million, or $0.17 per share, compared to a net loss of $8.9 million,
or
$0.26 per share, for the same period in 2006. As of December 31, 2007, the
company had cash, cash equivalents and investments of $81.4 million.
Revenues
for the fourth quarter of 2007 were $2.8 million, compared to $2.2 million
for
the same period in 2006. Fourth quarter 2007 revenues were primarily from
Sangamo's agreements with Dow AgroSciences (DAS), Sigma-Aldrich Corporation,
research grants and enabling technology agreements in protein
production.
Research
and development expenses were $7.9 million for the 2007 quarter, compared to
$10.1 million for the same period in 2006 which included the one-time costs
of
Sangamo's acquisition of Edwards Lifesciences' ZFP Therapeutic(TM)
angiogenesis program, a transaction valued at $5.8 million of common stock.
Excluding the one-time 2006 charge, the increase in research and development
expenses for the fourth quarter of 2007 of $3.6 million was primarily due to
advancing the Company's clinical development program in diabetic neuropathy
and
pre-IND programs to develop ZFP Therapeutics for the treatment of HIV/AIDS
and
glioblastoma, as well as increased R&D personnel costs and lab supply
expenses. General and administrative expenses were $2.5 million for the fourth
quarter of 2007, compared to $1.9 million for the same period in 2006. Total
operating expenses for the fourth quarter of 2007 were $10.4 million, compared
to $12.0 million for the same period in 2006.
Net
interest and other income was $935,000 for the fourth quarter of 2007, compared
to $858,000 for the same period in 2006, primarily due to higher average cash
and investment balances.
Full
Year
Results
For
the
year ended December 31, 2007, the consolidated net loss was $21.5 million,
or
$0.58 per share, compared to a net loss of $17.9 million, or $0.55 per share,
for the year ended December 31, 2006. Revenues were $9.1 million for 2007,
compared to $7.9 million in 2006. Total operating expenses were $33.9 million
in
2007 and $28.6 million in 2006. Operating expenses in 2006 included the
acquisition of the Edwards Lifesciences' ZFP Therapeutic angiogenesis program,
a
one-time cost for Sangamo of $5.8 million. The increase in operating expenses
for 2007 was primarily associated with Sangamo's clinical development program
in
diabetic neuropathy and pre-IND programs to develop ZFP Therapeutics for the
treatment of HIV/AIDS and glioblastoma, as well as increased R&D personnel
costs and lab supply expenses.
2007
Highlights
| -- |
Presentation
of first clinical 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 and
the
Society for Neuroscience Meeting in November. The data demonstrate
statistically significant improvement in quantitative sensory testing
and
clinically relevant trends toward improvement in nerve conduction
velocity
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 zinc finger DNA-binding
protein
transcription factor (ZFP TF(TM)), designed to upregulate the vascular
endothelial growth factor-A (VEGF-A)
gene.
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| -- |
Initiation
of additional Phase 2 clinical trials of SB-509 in moderate to severe
DN
(SB-509-701) and stem cell mobilization (SB-509-703). In April, Sangamo
announced the initiation of a randomized, single-blind,
placebo-controlled, repeat-dosing Phase 2 study designed to evaluate
the
clinical safety and effects of repeat administration of SB-509 in
subjects
that have moderate to severe DN (SB-509-701). In January 2008, Sangamo
announced that it had initiated a randomized, single-blind,
placebo-controlled, multi-center Phase 2 clinical trial (SB-509-703)
in
subjects with mild to moderate DN designed to evaluate the
pharmacokinetics of stem cell mobilization into the bloodstream after
treatment with varying doses of SB-509 as well as the clinical safety
and
clinical effects of SB-509
administration.
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| -- |
Completion
of enrollment of Phase 2 clinical trial of SB-509 for mild to moderate
DN
(SB-509-601). In December, Sangamo announced that enrollment was
complete
in a randomized, double-blind, repeat-dosing, placebo-controlled,
multi-center trial to evaluate SB-509 for the treatment of mild to
moderate DN. The company expects to have data from this trial in
the
second half of 2008.
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Establishment
of major alliance with Sigma-Aldrich Corporation. In July, as part
of an
agreement to develop and commercialize high value laboratory research
reagents based upon Sangamo's ZFP technology, Sangamo received an
upfront
payment of $13.5 million which included license fees and the purchase
of
one million shares of Sangamo stock. Sangamo is also eligible to
receive
research funding, development and commercial milestone payments of
up to
$24 million and sublicense payments and royalties on product
sales.
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| -- |
Achievement
of multiple milestones in Dow AgroSciences collaboration. As part
of their
joint Research and Commercial License Agreement the companies achieved
milestones that represent the successful application of Sangamo's
ZFP
technology to the generation of specific traits in two major crop
species
-- maize and canola.
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| -- |
Sangamo
closed a registered direct offering to institutional investors. In
July,
Sangamo sold an aggregate of 3,278,689 shares of common stock to
a group
of institutional investors in a registered direct offering, resulting
in
gross proceeds to the company of approximately $30 million before
fees and
expenses.
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| -- |
Appointment
of H. Ward Wolff as Executive Vice President and Chief Financial
Officer
(CFO). In December 2007, Mr. Wolff joined Sangamo's senior management
team
after serving on the Board of Directors of the Company since June
2006. In
this newly created position, Mr. Wolff oversees the company's
administrative, financial and business development activities and
operations.
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Sangamo
hosted an Investor and Analyst Briefing. On December 5, Sangamo provided
an update on its achievements in 2007, its therapeutic programs,
progress
in its collaboration with Dow AgroSciences and its objectives for
2008
during its annual Investor and Analyst Briefing held in New York.
The
event was webcast and the replay is available on Sangamo's website
at
http://investor.sangamo.com/events.cfm
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2008
Objectives
In
today's conference call members of Sangamo's management team will discuss the
company's plans and objectives for 2008 that include:
Therapeutic
Programs
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Present
additional data from the completed Phase 1b study designed to evaluate
the
effect of a single administration of SB-509 in subjects with mild
to
moderate DN.
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| -- |
Complete
follow-up and presentation of data in the second half of the year
from a
Phase 2 study (SB-509-601) to evaluate the effects of SB-509 in subjects
with mild to moderate DN.
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| -- |
Complete
accrual,
follow-up and presentation of data from a Phase 2 study (SB-509-701)
to
evaluate SB-509 in subjects with moderate to severe
DN.
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| -- |
Complete
accrual and treatment in the recently initiated Phase 2 pharmacokinetic
trial (SB-509-703) to evaluate the effect of SB-509 on stem cell
mobilization
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Initiate
a Phase 2 clinical trial to evaluate SB-509 for the treatment of
ALS
(Amyotrophic Lateral Sclerosis, also known as "Lou Gehrig's
disease").
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Advance
ZFP Therapeutic pipeline by initiating Phase 1 clinical trials of
ZFP
Therapeutics for glioblastoma and HIV /
CCR5.
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Present
preclinical data in spinal cord injury, stroke, neuropathic pain
and
ZFN(TM)-mediated gene modification.
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Business
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Strategic
Collaborations & Enabling Technology
Agreements
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Pursue
strategic partnering in ZFP
Therapeutics.
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Achieve
additional research milestones in Dow AgroSciences collaboration
in plant
agriculture.
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Increase
visibility and value of ZFNs by developing commercial research reagents
in
collaboration with Sigma-Aldrich.
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Establish
new commercial license agreements using ZFNs to improve cell-lines
used in
protein production and other biological
applications.
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Financials
and Operations
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Maintain
year-end 2008 cash and investments balance of at least $55.0
million.
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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 with respect to 2008.
The
conference call dial-in numbers are 877-545-1489 for domestic callers and
719-325-4844 for international callers. The passcode for the call is 4452025.
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
5:00 p.m. PT on February 5, 2008 to 11:59 p.m. PT on February 12, 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 4452025.
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 Therapeutic(TM) development program is currently in Phase 2
clinical trials for evaluation of safety and clinical effect in patients with
diabetic neuropathy. Phase 1 clinical trials are ongoing to evaluate a ZFP
Therapeutic for peripheral artery disease. 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 TF(TM)) that can control gene expression and,
consequently, cell function. Sangamo is also developing sequence-specific ZFP
Nucleases (ZFN(TM)) 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 http://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 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
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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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Twelve
Months Ended
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||||||||||||
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December
31,
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December 31,
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||||||||||||
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2007
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|
2006
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2007
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2006
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Consolidated
Statement of
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|||||||||||||
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Operations
Data:
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|||||||||||||
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Revenues
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$
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2,767
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$
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2,193
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$
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9,098
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$
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7,885
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Operating expenses:
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Research
and development
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7,904
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10,057
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25,559
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21,527
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General and
administrative
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2,470
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1,942
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8,310
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7,087
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Total operating
expenses
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10,374
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11,999
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33,869
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28,614
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Loss
from operations
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(7,607
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)
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(9,806
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)
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(24,771
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)
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(20,729
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)
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Interest and
other income, net
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935
|
858
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3,291
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2,865
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Net
loss
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$ | (6,672 | ) | $ | (8,948 | ) | $ | (21,480 | ) | $ | (17,864 | ) | |
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Basic
and diluted
net loss per
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|||||||||||||
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common
share
|
$
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(0.17
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)
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$
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(0.26
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)
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$
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(0.58
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)
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$
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(0.55
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)
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Shares
used in computing basic and
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|||||||||||||
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dilutednet
loss per common share
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40,226
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34,098
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37,355
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32,502
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|||||||||
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CONSOLIDATED
CONDENSED BALANCE SHEET
DATA
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|||||||
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December
31,
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December
31,
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||||||
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2007
|
2006
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||||||
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|||||||
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Cash, cash
equivalents, and investments
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81,412
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53,975
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|||||
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Total assets
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83,900
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55,780
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|||||
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Total stockholders'
equity
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72,122
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48,705
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