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 28,
2010
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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):
¨ 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
July 28, 2010, Sangamo BioSciences, Inc. issued a press release announcing its
financial results for the quarter ended June 30, 2010. 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.
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99.1
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Press
Release Issued July 28, 2010.
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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 28, 2010
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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 Reports Second Quarter 2010 Financial Results
RICHMOND,
Calif., July 28 /PRNewswire-FirstCall/ — Sangamo BioSciences, Inc. (Nasdaq:
SGMO) today reported second quarter 2010 financial results and
accomplishments.
For the
second quarter ended June 30, 2010, Sangamo reported a consolidated net loss of
$3.9 million, or $0.09 per share, compared to a net loss of $4.5 million, or
$0.11 per share, for the same period in 2009. As of June 30, 2010, the company
had cash, cash equivalents, marketable securities and interest receivable of
$69.3 million.
Revenues
for the second quarter of 2010 were $6.5 million, compared to $4.7 million for
the same period in 2009. Second quarter 2010 revenues were generated from the
Company's collaboration agreements with Sigma-Aldrich Corporation and Dow
AgroSciences (DAS), agreements relating to protein production and research
grants. The revenue recognized for the second quarter of 2010 consisted of $6.2
million in collaboration agreements and $0.3 million in research grants. The
increase in collaboration agreement revenues was primarily due to the license
payment received from Sigma-Aldrich as part of its agreement with the Company,
which was expanded in the fourth quarter of 2009 and provides Sigma exclusive
rights to develop and distribute zinc finger DNA-binding protein (ZFP)-modified
cell lines for commercial production of protein pharmaceuticals and
ZFP-engineered transgenic animals. The payment is being recognized as
revenue ratably through July 2010, the remaining period of the Company's
research services relating to the collaboration with Sigma-Aldrich.
Research
and development expenses were $7.1 million for the second quarter of 2010,
compared to $6.9 million for the same period in 2009. Research and development
expenses for the second quarter of 2010 were primarily related to our clinical
trials of SB-509 for diabetic neuropathy and SB-728-T for HIV/AIDS, and
personnel costs, including non-cash employee stock-based
compensation. General and administrative expenses were $3.3 million
for the second quarter of 2010, compared to $3.0 million for the same period in
2009. The increase in general and administrative expenses was primarily due to
increased personnel costs, including non-cash employee stock-based
compensation.
Total
operating expenses for the second quarter of 2010 were $10.4 million, compared
to $9.9 million for the same period in 2009.
Net
interest and other income was $19,000 for the second quarter of 2010, compared
to $647,000 for the same period in 2009. The decrease was primarily due to lower
interest rates on investments and an unrealized foreign currency remeasurement
gain of $493,000 in the 2009 period.
Six
Months Results
For the
six months ended June 30, 2010, the consolidated net loss was $7.8 million, or
$0.17 per share, compared to a consolidated net loss of $11.3 million, or $0.28
per share, for the six months ended June 30, 2009. Revenues were
$13.2 million for the first half of 2010, compared to $7.9 million in the same
period in 2009. Total operating expenses were $21.1 million for the first half
of 2010 and $20.1 million in the first half of 2009.
Recent
Highlights
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·
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Presentation of Positive Phase
2 ZFP Therapeutic™ Data at ADA. Sangamo presented positive Phase 2
clinical data from its ZFP Therapeutic program to develop SB-509 as a
treatment for diabetic neuropathy (DN) at the 69th Annual Scientific
Sessions of the American Diabetes Association (ADA). The data
from Sangamo's SB-509-601 and SB-509-701B trials demonstrated that SB-509
treatment resulted in statistically significant and clinically beneficial
improvements in subjects with moderate and severe DN as compared to
placebo and provided direct histological evidence of SB-509's dual effect
on both blood vessel and nerve growth. These data further
validate the strategy of using multiple endpoints to assess disease
severity in the enrollment of subjects with moderately severe DN into
Sangamo's ongoing Phase 2b
trial.
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·
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Publication of Preclinical Data
in Nature
Biotechnology
Demonstrating Promising Stem Cell Therapeutic
Strategy for HIV/AIDS. The data demonstrate the preclinical
efficacy of a human stem cell therapy for human immunodeficiency virus
(HIV) based on Sangamo's proprietary ZFP nuclease (ZFN) technology. The
ZFN approach enables the permanent disruption of the CCR5 gene, which
encodes an important receptor for HIV infection, in all the cell types
comprising the immune system that develop from hematopoietic stem cells
(HSCs), and is the basis for a promising therapeutic strategy for the
treatment of HIV/AIDS. The work was carried out by Sangamo
scientists and collaborators at the Keck School of Medicine of the
University of Southern California and was published (http://www.nature.com/nbt/journal/vaop/ncurrent/full/nbt.1663.html)
as an Advance Online Publication. Sangamo has two ongoing Phase
1 clinical trials to evaluate the safety and clinical efficacy of
SB-728-T, a treatment for HIV/AIDS based on ZFN-mediated disruption of the
CCR5 gene in CD4+ T-cells.
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·
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Second Round of
Funding Awarded by Michael J. Fox
Foundation for Parkinson's Research. The $895,000 award, which will
be paid over a period of two years, will support studies in non-human
primates for the development of a ZFP Therapeutic to treat Parkinson's
disease.
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·
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Sangamo BioSciences and
Collaborators Present Broad Therapeutic Applications of ZFP
Technology. Sangamo scientists and collaborators presented data
from a broad range of research and preclinical programs focused on the
development of ZFP Therapeutics at the 13th Annual Meeting of the American
Society of Gene and Cell Therapy (ASGCT). Therapeutic areas
included ZFN-based approaches in primary human cells and stem cells to
infectious diseases such as HIV/AIDS and cytomegalovirus (CMV), monogenic
diseases, and oncology. Positive preclinical data were also
presented from experiments using Sangamo's gene regulation technology to
up-regulate the vascular endothelial growth factor-A gene in an animal
model of traumatic brain injury.
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Conference
Call
Sangamo
will host a conference call today, July 28, 2010 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 the remainder of
2010.
The
conference call dial-in numbers are 877-377-7553 for domestic callers and 678
894-3968 for international callers. The passcode for the call is
84971039. 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 28, 2010 to midnight ET on August
4, 2010. The conference call replay numbers for domestic and international
callers are 800-642-1687 and 706-645-9291, respectively. The conference ID
number for the replay is 84971039.
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™ development program
is currently in a Phase 2b clinical trial for evaluation of safety and clinical
effect in patients with diabetic neuropathy and a Phase 2 trial in ALS. Sangamo
also has two Phase 1 clinical trials to evaluate safety and clinical effect of a
treatment for HIV/AIDS and another Phase 1 trial to evaluate safety and clinical
effect of a treatment for recurrent glioblastoma multiforme. Other therapeutic
development programs are focused on 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) that can control gene expression and, consequently, cell
function. Sangamo is also developing sequence-specific ZFP Nucleases
(ZFN) for gene modification. Sangamo has established strategic
partnerships with companies in non-therapeutic applications of its technology
including Dow AgroSciences and Sigma-Aldrich Corporation. For more information
about Sangamo, visit the company's website 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 and commercial license agreements with collaborators, presentation
of data from research collaborations and recognition of revenues under
collaboration agreements. 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.
SELECTED
CONSOLIDATED 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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June
30,
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June
30,
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2010
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2009
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2010
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2009
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Statement
of Operations Data:
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Revenues
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Collaboration
agreements
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$ | 6,210 | $ | 4,213 | $ |
12,409
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$ |
7,370
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Research
grants
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315 | 513 |
764
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513
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Total
revenues
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6,525 | 4,726 |
13,173
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7,883
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Operating
expenses:
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Research
and development
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7,147 | 6,877 |
14,512
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14,133
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General
and administrative
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3,257 | 3,007 |
6,543
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5,933
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Total
operating expenses
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10,404 | 9,884 |
21,055
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20,066
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Loss
from operations
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(3,879 | ) | (5,158 | ) |
(7,882
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(12,183
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Interest
and other income, net
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19 | 647 |
44
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840
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Net
loss
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$ | (3,860 | ) | $ | (4,511 | ) | $ |
(7,838
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(11,343
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Basic
and diluted net loss per common share
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$ | (0.09 | ) | $ | (0.11 | ) |
(0.17
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(0.28
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Shares
used in computing basic and diluted net loss per common
share
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45,157 | 41,123 |
45,096
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41,094
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SELECTED
BALANCE SHEET
DATA
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June
30,
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December
31,
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2010
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2009
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(Unaudited)
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Cash,
cash equivalents, marketable securities and interest
receivable
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$ | 69,276 | $ | 85,281 | ||||
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Total
assets
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72,105 | 87,439 | ||||||
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Total
stockholders' equity
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68,468 | 71,782 | ||||||
CONTACT:
Elizabeth Wolffe, Ph.D. of Sangamo BioSciences, Inc., +1-510-970-6000, ext.
271