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 4,
2009
SANGAMO
BIOSCIENCES, INC.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
(State or
Other Jurisdiction of Incorporation)
|
000-30171
|
68-0359556
|
|
(Commission
File Number)
|
(IRS
Employer Identification
No.)
|
|
Richmond,
California 94804
|
||
|
(Address
of Principal Executive Offices)
|
(Zip
Code)
|
(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):
¨ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
¨ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
¨ 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 4, 2009, Sangamo BioSciences, Inc. issued a press release announcing
its financial results for the quarter and year ended December 31,
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
(d) 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 4, 2009.
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.
|
DATE:
February 4, 2009
|
|||
|
SANGAMO
BIOSCIENCES, INC.
|
|||
|
By:
|
/s/
EDWARD O. LANPHIER II
|
||
|
Edward
O. Lanphier II
|
|||
|
President,
Chief Executive
Officer
|
|||
 |
Sangamo
BioSciences, Inc.
|
|
Point
Richmond Tech Center
|
|
|
501
Canal Boulevard
|
|
|
Richmond,
CA 94804
|
|
|
510-970-6000
l
510-236-8951(Fax)
|
SANGAMO
BIOSCIENCES REPORTS FOURTH QUARTER AND FULL YEAR
2008
FINANCIAL RESULTS
Company
Ends Year with Cash and Investments of $65.0 Million
Richmond, California –
February 4, 2009 – Sangamo BioSciences, Inc. (Nasdaq: SGMO) today reported
fourth quarter and full year 2008 financial results and accomplishments and
provided an outlook for 2009.
For the
fourth quarter ended December 31, 2008, Sangamo reported a consolidated net loss
of $2.6 million, or $0.06 per share, compared to a net loss of $6.7 million, or
$0.17 per share, for the same period in 2007. As of December 31, 2008, the
company had cash, cash equivalents marketable securities and interest receivable
of $65.0 million.
Revenues
for the fourth quarter of 2008 were $6.8 million, compared to $2.8 million for
the same period in 2007. Fourth quarter 2008 revenues were primarily from
Sangamo’s enabling technology agreements in cell line engineering for protein
production including $3.0 million related to a fully-paid non-exclusive license
agreement with Pfizer Inc and revenues from Sangamo’s agreement with Genentech,
Inc., as well as Sangamo’s agreements with Dow AgroSciences (DAS) and
Sigma-Aldrich Corporation.
Research
and development expenses were $6.7 million for the fourth quarter of 2008,
compared to $7.9 million for the same period in 2007. The decrease in
research and development expenses for the fourth quarter of 2008 was primarily
due to reduced expenses related to clinical trials as studies of our drug SB-509
progressed. Non-cash stock-based compensation included in research
and development expenses totaled $605,000 and $409,000 in the fourth quarter of
2008 and 2007, respectively.
General
and administrative expenses were $2.3 million for the fourth quarter of 2008,
compared to $2.5 million for the same period in 2007. Non-cash stock-based
compensation included in general and administrative expenses totaled $864,000
and $388,000 in the fourth quarter of 2008 and 2007, respectively.
Total
operating expenses for the fourth quarter of 2008 were $9.0 million, compared to
$10.4 million for the same period in 2007.
Net
interest income (expense) was ($375,000) for the fourth quarter of 2008,
compared to $935,000 for the same period in 2007. The decrease was
due to lower average investment balances and lower interest rates as well as a
foreign currency translation loss during the quarter.
Full
Year Results
For the
year ended December 31, 2008, the consolidated net loss was $24.3 million, or
$0.60 per share, compared to a net loss of $21.5 million, or $0.58 per share,
for the year ended December 31, 2007. Revenues were $16.2 million for
2008, compared to $9.1 million in 2007. The increase in revenues for 2008 was
primarily attributable to the exercise by DAS of its option for a commercial
license to Sangamo’s technology in plant agriculture, Sangamo’s enabling
technology agreements in protein production and its agreement with Sigma-Aldrich
for research reagents. Total operating expenses were $41.6 million in 2008 and
$33.9 million in 2007. The increase in operating expenses for 2008 was primarily
associated with Sangamo’s clinical development programs in diabetic neuropathy
(DN) and amyotrophic lateral sclerosis (ALS) 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.
2008
Highlights
|
|
·
|
Filing of an Investigational
New Drug (IND) application for Sangamo’s ZFP Therapeutic program in
HIV/AIDS. Phase 1 clinical trial open. In December, our
collaborators at the University of Pennsylvania filed an IND application
to initiate a clinical trial to evaluate SB-728-T for the treatment of
HIV/AIDS. The trial is now open and enrolling subjects. Based on Sangamo’s
zinc finger DNA-binding protein (ZFP) nuclease (ZFNTM)
technology, 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
that are resistant to the virus in an animal model of HIV
infection.
|
|
|
·
|
Initiation of Phase 2 clinical
trial (SB-509-801) of SB-509 in amyotrophic lateral sclerosis (ALS).
In September, Sangamo initiated a Phase 2 clinical trial
(SB-509-801) to evaluate SB-509, a ZFP transcription factor (ZFP TFTM)
VEGF-A activator, in subjects with ALS. ALS is a progressive,
degenerative motor-neuron disease for which there are limited treatment
options and no cure. The rationale for the study is based on improvements
in motor nerve function observed in Sangamo’s SB-509 trials in DN. The
study 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.
|
|
|
·
|
Presentation of data from
clinical trials of SB-509 for DN. In June and November,
Sangamo presented data from its Phase 1 (SB-509-401) and Phase 2
(SB-509-601 and SB-509-701 Part A) clinical trials of SB-509 for
DN. The studies demonstrated that repeat dosing of SB-509 is
well-tolerated in subjects with DN. The SB-509-401 study
demonstrated a statistically significant positive correlation of 2 or more
response endpoints in the SB-509 treated group compared with placebo
treated subjects at day 180 post a single treatment. Interim
data from the SB-509-701 Phase 2 trial
suggested encouraging recovery of sural nerve conduction velocity (NCV) in
SB-509-treated compared to placebo-treated subjects. Sangamo expanded this
trial to test a more frequent dosing regimen (Part B). Top-line data from
the SB-509-601 study did not reveal any difference between treated and
untreated subjects. However, further analysis of the data has defined the
target population of subjects with DN for which this drug may be most
effective. We expect to present further data from Phase 2
studies in DN in 2009.
|
|
|
·
|
Dow AgroSciences (DAS)
announces early exercise
of commercial license for ZFP technology. In June, DAS exercised
its option, under an existing agreement with Sangamo, for a commercial
license to Sangamo’s ZFP technology for use in plant
agriculture. DAS is using the technology to generate its own
products and plans to sublicense the technology to other companies under
the trademark of ExZact Precision TechnologyTM.
As part of the agreement, Sangamo received 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.
|
|
|
·
|
Announcement of agreements for
the use of ZFP technology to develop cell lines and transgenic
animals. In July, Sangamo and Sigma-Aldrich Corporation jointly
announced a research and license agreement to provide Hoffman-La 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. In December,
Sangamo and Pfizer Inc entered into an agreement to provide Pfizer with a
worldwide, non-exclusive license for the use of ZFN reagents to knock out
a single gene in CHO cells and for the use of such cell lines for clinical
and commercial production of therapeutic proteins. Under the
terms of the agreement Sangamo received a payment of $3.0 million from
Pfizer for a fully paid license.
|
|
|
·
|
Achievement of key throughput
milestone over a year ahead of schedule in agreement with Sigma-Aldrich
Corporation. Sangamo announced it reached a major production
throughput milestone as part of its agreement with Sigma-Aldrich to
commercialize ZFNs for research applications. The milestone triggered a
payment of $1.0 million to Sangamo.
|
|
|
·
|
Publication of preclinical data
and data from research projects. Publications 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.
|
|
|
·
|
Sangamo’s ZFN technology
recognized as top innovation by The
Scientist and
Wired.com.
The Scientist recognized custom ZFNs as one of the top innovations of 2008
and Sangamo’s ZFN gene-editing technology was cited in an article on Wired.com on their “Top Ten
Scientific Breakthroughs” of
the year.
|
|
|
·
|
Sangamo hosted an Investor and
Analyst Briefing. On December 3, Sangamo provided
an update on its achievements in 2008, its therapeutic programs, progress
in its collaboration with Sigma-Aldrich Corporation and its objectives for
2009 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
|
2009
Objectives
In
today’s conference call members of Sangamo’s management team will discuss the
company’s plans and objectives for 2009 that include:
Therapeutic
Programs
|
|
·
|
Present
data from Phase 2 studies of SB-509 for DN at appropriate medical
conferences.
|
|
|
·
|
Complete
accrual and treatment in expanded Phase 2 trial (SB-509-701 Part B) to
evaluate SB-509 subjects with moderate to severe DN and Phase 2 study
(SB-509-801) in subjects with ALS.
|
|
|
·
|
Advance
ZFP Therapeutic pipeline by initiating Phase 1 clinical trial of ZFP
Therapeutics for HIV/AIDS and
glioblastoma.
|
|
|
·
|
Present
preclinical data in spinal cord injury, neuropathic pain, Parkinson’s
disease and ZFNTM-mediated
gene modification.
|
Business
- - Strategic Collaborations & Enabling Technology Agreements
|
|
·
|
Pursue
strategic partnerships in ZFP
Therapeutics.
|
|
|
·
|
DAS
executes commercial sublicenses of ZFP technology in plant
agriculture.
|
|
|
·
|
Increase
visibility and value of ZFNs by developing research reagents in
collaboration with Sigma-Aldrich Corporation and achievement of additional
development milestones and
royalties.
|
|
|
·
|
Establish
new commercial license agreements using ZFNs to improve cell-lines used in
protein production and other biological
applications.
|
|
|
·
|
Present
and publish data from research collaborations in plant agriculture,
transgenic animal production and cell-line
engineering.
|
Financials
and Operations
|
|
·
|
Maintain
year-end 2009 cash and investments balance of at least $45.0
million.
|
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 guidance with respect to 2009.
The
conference call dial-in numbers are 877-681-3378 for domestic callers and
719-325-4765 for international callers. The passcode for the call is
6408611. 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 February 4, 2009 to 11:59 p.m. ET on
February 11, 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 6408611.
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.
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 and commercial license agreements with collaborators, presentation
of data from research collaborations and anticipated cash and investments
balance. 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
Sangamo BioSciences,
Inc.
Elizabeth
Wolffe, Ph.D.
510-970-6000,
x271
-more-
SELECTED
FINANCIAL DATA
(in
thousands, except per share data)
(unaudited)
|
Three
Months Ended
|
Twelve
Months Ended
|
|||||||||||||||
|
December
31,
|
December
31,
|
|||||||||||||||
|
2008
|
2007
|
2008
|
2007
|
|||||||||||||
|
Consolidated
Statement of Operations Data:
|
||||||||||||||||
|
Revenues
|
||||||||||||||||
|
Collaboration
agreement
|
$ | 6,834 | $ | 2,255 | $ | 14,492 | $ | 6,781 | ||||||||
|
Research
grants
|
- | 511 | 1,694 | 2,317 | ||||||||||||
|
Total
revenues
|
6,834 | 2,766 | 16,186 | 9,098 | ||||||||||||
|
Operating
expenses:
|
||||||||||||||||
|
Research
and development
|
6,737 | 7,904 | 31,229 | 25,559 | ||||||||||||
|
General
and administrative
|
2,296 | 2,470 | 10,332 | 8,310 | ||||||||||||
|
Total
operating expenses
|
9,033 | 10,374 | 41,561 | 33,869 | ||||||||||||
|
Loss
from operations
|
(2,199 | ) | (7,608 | ) | (25,375 | ) | (24,771 | ) | ||||||||
|
Interest
income (expense), net
|
(375 | ) | 935 | 1,073 | 3,291 | |||||||||||
|
Net
loss
|
$ | (2,574 | ) | $ | (6,673 | ) | $ | (24,302 | ) | $ | (21,480 | ) | ||||
|
Basic
and diluted net loss per common share
|
$ | (0.06 | ) | $ | (0.17 | ) | $ | (0.60 | ) | $ | (0.58 | ) | ||||
|
Shares
used in computing basic and diluted net loss per common
share
|
41,018 | 40,226 | 40,825 | 37,355 | ||||||||||||
|
CONSOLIDATED
CONDENSED BALANCE SHEET DATA
|
||||||||
|
December
31,
2008
|
December
31,
2007
|
|||||||
|
Cash,
cash equivalents, marketable securities and interest
receivable
|
$ | 65,025 | $ | 81,412 | ||||
|
Total
assets
|
67,850 | 83,900 | ||||||
|
Total
stockholders' equity
|
55,396 | 72,122 | ||||||
###