Sangamo BioSciences, Inc. (NASDAQ:SGMO), Richmond, Calif., has
reported second quarter 2008 financial results and accomplishments.
For the second quarter ended June 30, 2008, Sangamo reported a
consolidated net loss of $7.4 million, or $0.18 per share, compared to a
net loss of $5.2 million, or $0.15 per share, for the same period in
2007. As of June 30, 2008, the company had cash, cash equivalents and
investments of $64.3 million.
Revenues for the second quarter of 2008 were $2.8 million, compared
to $2.6 million for the second quarter of 2007. Second 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 second quarter of 2008
consisted of $2.4 million in collaboration agreements and $464,000 in
research grants.
Research and development expenses were $8.3 million for the second
quarter of 2008, compared to $6.3 million for the same period in 2007.
The increase in research and development expenses for the second 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
employee stock-based compensation included in research and development
expenses totaled $0.7 million and $0.3 million in the second quarter of
2008 and 2007, respectively.
General and administrative expenses were $2.5 million for the
second quarter of 2008, compared to $2.1 million for the same period in
2007. The increase in general and administrative expenses was primarily
due to increased personnel costs, including non-cash employee
stock-based compensation which totaled $0.6 million in the second
quarter of 2008 compared to $0.2 million in the same period in 2007.
Total operating expenses for the second quarter of 2008 were $10.8
million, compared to $8.4 million for the same period in 2007.
Net interest and other income was $570,000 for the second quarter
of 2008, compared to $657,000 for the same period in 2007.
Six Month Results
For the six months ended June 30, 2008, the consolidated net loss
was $15.4 million, or $0.38 per share, compared to a net loss of $10.5
million, or $0.30 per share, for the period ended June 30, 2007.
Revenues were $5.6 million for the first half of 2008, compared to $4.0
million in the same period in 2007. Total operating expenses were $22.4
million for the first half of 2008 and $15.9 million in the first half
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
-- Dow AgroSciences announces early exercise of commercial license
for ZFP technology. Four months earlier than expected Dow AgroSciences
(DAS) announced during the BIO International Convention in June that
they had exercised their option, under and existing agreement with
Sangamo, for a commercial license to Sangamo's zinc finger
DNA-binding protein (ZFP) technology for use in plant agriculture. DAS
will use the technology to generate products itself and plans to
sublicense the technology to other companies under the trademark of
ExZact Precision Traits(TM). As part of the agreement, Sangamo will
receive 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. A webcast replay of the press conference that
DAS hosted is available on Sangamo's website on the Investor page
under Events and Presentations.
-- Presentation of complete 180 day follow-up 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. The data demonstrate statistically
significant improvement in quantitative sensory testing and Neuropathy
Impairment Score-Lower Limbs (NIS-LL), a quantitative measure of the
neurologic exam, as well as clinically relevant trends toward
improvement in nerve conduction velocities. The trial was conducted 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 ZFP transcription factor (ZFP
TF(TM)), designed to upregulate the vascular endothelial growth factor-A
(VEGF-A) gene.
-- Phase 2 clinical trial, SB-509-701 fully enrolled and expanded.
A Phase 2 study of SB-509 is being undertaken in subjects with moderate
to severe diabetic neuropathy with at least one "blocked
nerve". In addition to the announcement of the completion of
accrual of the first part of the trial, Sangamo announced plans to
expand and broaden the trial to test an additional dosing regimen.
-- Data from critical limb ischemia Phase 1 trial presented at the
International Society for Cellular Therapy Meeting. Sangamo's
collaborators from Duke University presented data from the completed
Phase 1 trial of the company's ZFP TF activator of VEGF-A for the
treatment of critical limb ischemia. The data from this trial
demonstrated that administration of the ZFP transcription factor
resulted in a statistically significant increase in circulating stem
cells in the peripheral blood. In addition, within a subgroup in which
bone marrow cells were examined before and after treatment, the data
suggests that subjects who showed the most marked clinical improvements,
as judged by limb salvage, ulcer healing, reduction in pain and
increased oxygen concentrations in the tissues of the lower limbs, also
showed the greatest increase in bone marrow stem cells. This observation
of stem cell mobilization after treatment with Sangamo's ZFP TF
activator of VEGF-A, is being further investigated in an ongoing Phase 2
trial of SB-509, SB-509-703.
-- Announcement of research and license agreement with F.
Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (Roche) for the use of
ZFP technology to develop transgenic animals. In July, Sangamo and
Sigma-Aldrich Corporation jointly announced a research and license
agreement to provide Roche with non-exclusive, worldwide rights for the
use of Sangamo's ZFP nuclease (ZFN(TM)) 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.
-- Publication of preclinical data in Nature Biotechnology. Papers
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.
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. 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, visit http://www.sangamo.com.
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