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): May 3,
2010
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):
¨ 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
May 3, 2010, Sangamo BioSciences, Inc. issued a press release announcing its
financial results for the quarter ended March 31, 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.
99.1 Press
Release Issued May 3, 2010.
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:
May 3, 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, Inc.
Point
Richmond Tech Center
501
Canal Boulevard
Richmond,
CA 94804
510-970-6000
·
510-236-8951(Fax)
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SANGAMO
BIOSCIENCES REPORTS FIRST QUARTER 2010
FINANCIAL
RESULTS
Richmond, California – May 3,
2010 – Sangamo BioSciences, Inc. (Nasdaq: SGMO) today reported first quarter
2010 financial results and accomplishments.
For the
first quarter ended March 31, 2010, Sangamo reported a consolidated net loss of
$4.0 million, or $0.09 per share, compared to a net loss of $6.8 million, or
$0.17 per share, for the same period in 2009. As of March 31, 2010, the company
had cash, cash equivalents, marketable securities and interest receivable of
$77.0 million.
Revenues
for the first quarter of 2010 were $6.6 million, compared to $3.2 million for
the same period in 2009. First quarter 2010 revenues were from the Company’s
collaboration agreements with Sigma-Aldrich Corporation and Dow AgroSciences,
enabling technology agreements and research grants. The revenue recognized for
the first quarter of 2010 consisted of $6.2 million in collaboration and
enabling technology agreements and $449,000 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 original
research collaboration with Sigma-Aldrich.
Research
and development expenses were $7.4 million for the first quarter of 2010,
compared to $7.3 million for the same period in 2009. Research and
development expenses for the first quarter of 2010 were primarily related to our
clinical trials of SB-509 for diabetic neuropathy and SB-728-T for
HIV/AIDS. General and administrative expenses were $3.3 million for
the first quarter of 2010, compared to $2.9 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,
and professional fees.
Total
operating expenses for the first quarter of 2010 were $10.7 million, compared to
$10.2 million for the same period in 2009.
Net
interest income and other income was $25,000 for the first quarter of 2010,
compared to $193,000 for the same period in 2009. The decrease was
due to lower interest rates on investments.
Recent
Highlights
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·
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Initiation of New Clinical
Trials; Phase 2b study in Diabetic Neuropathy and Phase 1 Trial in Brain
Cancer (Glioblastoma) with City of Hope: In January 2010, Sangamo
initiated a Phase 2b trial of SB-509 in subjects with moderately severe
diabetic neuropathy. The Juvenile Diabetes Research Foundation
International (JDRF) also renewed its support for this program and will
provide up to $3.0 million of funding for the trial. Sangamo’s double
blind, repeat-dosing, placebo-controlled Phase 2b study, SB-509-901, is
designed to finalize dose, schedule and primary and secondary approvable
endpoints for pivotal Phase 3 trials. Sangamo’s collaborators at City of
Hope also initiated a Phase 1 clinical trial of SB-313, a cytotoxic T-cell
made glucocorticoid resistant using ZFN mediated gene-editing, that is
being evaluated in subjects with recurrent or refractory
glioblastoma.
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·
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Presentation of Preliminary
Data from Sangamo’s Phase 1 Safety Trial of SB-728-T for
HIV/AIDS: In January
2010, preliminary data from the University of Pennsylvania investigator
sponsored Phase 1 safety study of Sangamo's zinc finger nuclease (ZFN)
based product, SB-728-T, for HIV/AIDS were presented at the Keystone
Symposium Session "HIV Biology and Pathogenesis." Sangamo's collaborator,
Carl June, M.D., Director of Translational Research at the Abramson Family
Cancer Research Institute at the University of Pennsylvania School of
Medicine, presented the data as an invited speaker in an NIAID Workshop
entitled "The Next Challenge: Elimination of HIV Reservoirs." Dr. June described
data from a single HIV- positive subject treated with SB-728-T who, as
part of the study, began a structured treatment interruption (STI) from
his antiviral drug therapy after being treated with CCR5 negative
ZFN-modified T-cells. During the monitoring period, the subject had stable
levels of ZFN-modified T-cells which were well-tolerated and stable
CD4+ T-cell counts. Interestingly, while the subject’s viral load
increased as expected during the STI period, the timing of the increase
was somewhat delayed. Biopsy samples demonstrated that ZFN-modified cells
appeared to circulate and traffic
normally.
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·
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Appointment of Two New Members
of the Sangamo Board of Directors, Stephen G. Dilly, M.B.B.S, Ph.D. and
William R. Ringo as Chairman of the Board: Dr. Dilly,
who is currently President and CEO of APT Pharmaceuticals, Inc., a
specialty drug company, was appointed to the board of directors effective
March 31, 2010. Dr. Dilly has
been closely associated with the development and launch of marketed drugs
for many therapeutic areas in his previous senior executive positions in
drug development at Chiron BioPharma, Genentech Inc. and SmithKline
Beecham in the U.K. Mr. Ringo, who recently retired as Senior
Vice President of Business Development, Strategy and Innovation at Pfizer
Inc. where he had responsibility for guiding Pfizer’s overall strategic
planning and business development activities, was appointed as Chairman of
the Sangamo Board of Directors on April 16,
2010.
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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. A
replay of the webcast 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 rest 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
70476823. 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 May 3, 2010 to 11:59 p.m. ET on May 10,
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 70476823.
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 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 TFs) that can control gene
expression and, consequently, cell function. Sangamo is also
developing sequence-specific ZFP Nucleases (ZFNs) 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 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 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
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Sangamo BioSciences,
Inc.
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Elizabeth
Wolffe, Ph.D.
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510-970-6000,
x271
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-more-
SELECTED
CONSOLIDATED FINANCIAL DATA
(in
thousands, except per share data)
(unaudited)
Statement
of Operations Data:
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Three Months Ended
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March 31,
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2010
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2009
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Revenues
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Collaboration
agreements
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$ | 6,199 | $ | 3,157 | ||||
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Research
grants
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449 | — | ||||||
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Total
revenues
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6,648 | 3,157 | ||||||
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Operating
expenses:
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||||||||
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Research
and development
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7,365 | 7,256 | ||||||
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General
and administrative
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3,286 | 2,926 | ||||||
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Total
operating expenses
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10,651 | 10,182 | ||||||
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Loss
from operations
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(4,003 | ) | (7,025 | ) | ||||
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Interest
and other income, net
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25 | 193 | ||||||
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Net
loss
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$ | (3,978 | ) | $ | (6,832 | ) | ||
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Basic
and diluted net loss per common share
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$ | (0.09 | ) | $ | (0.17 | ) | ||
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Shares
used in computing basic and diluted net loss per common
share
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45,033 | 41,066 | ||||||
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March 31, 2010
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December 31, 2009
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(Unaudited)
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SELECTED
BALANCE SHEET DATA
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Cash,
cash equivalents, marketable securities and interest
receivable
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$ | 76,979 | $ | 85,281 | ||||
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Total
assets
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79,355 | 87,439 | ||||||
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Total
stockholders' equity
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70,014 | 71,782 | ||||||
###