Richmond, California
May 1, 2006
Sangamo BioSciences, Inc.
(Nasdaq: SGMO) today reported financial results for the quarter
ended March 31, 2006. The consolidated net loss was $2.7
million, or $0.09 per share, as compared to a net loss of $3.6
million, or $0.14 per share, in the same period of 2005. At
March 31, 2006, the company had cash, cash equivalents,
investments and interest receivable of $42.7 million.
Revenues for the first quarter
of 2006 were $2.1 million as compared to first quarter 2005
revenues of $256,000. First quarter 2006 revenues were from
Sangamo's partnerships in the areas of plant agriculture,
federal government research grants, enabling technologies and
human therapeutics.
Total first quarter 2006
operating expenses were $5.3 million as compared to $3.8 million
in the prior year period. Research and development expenses were
$3.6 million for the three months ended March 31, 2006 as
compared to $2.7 million for the first quarter of 2005. General
and administrative expenses were $1.8 million for the first
quarter of 2006 as compared to $1.1 million for the same period
in 2005. Total expenses included a non-cash charge of $430,000
during the first quarter ended March 31, 2006 for employee
stock-based compensation. As of January 1, 2006 the Company has
adopted Statement of Financial Accounting Standards No. 123R and
is reporting employee-stock based compensation expense in our
GAAP results for the first time.
Net interest and other income
for the first quarter of 2006 was $464,000 as compared to
$27,000 in the comparable period of 2005.
Recent Highlights
-- Sangamo BioSciences announced the presentation of the first data from a
human clinical trial of a ZFP Therapeutic(TM). On April 6, positive
results from the Phase 1 human clinical trial of SB-509, the Company's
zinc finger DNA-binding protein (ZFP) Therapeutic for the treatment of
diabetic neuropathy were presented at the 58th Annual Meeting of the
American Academy of Neurology. All of the safety end-points of the
study were met. Adverse events were limited to mild injection site
reaction, there were no serious drug-related events, and no dose-
limiting toxicities were observed. In addition, anecdotal improvements
in clinical symptoms were also reported. SB-509 is a ZFP transcription
factor (ZFP TF(TM)), engineered to activate or "turn on" the expression
of the VEGF-A gene for the treatment of diabetic neuropathy. The Phase
I human clinical trial was designed to evaluate the safety and maximum
tolerated dose of the ZFP Therapeutic, which in preclinical studies in
diabetic rats was shown to reduce disease-induced nerve damage.
Sangamo expects to initiate a placebo-controlled, multi-treatment Phase
2 study in diabetic subjects with mild to moderate sensory/motor
neuropathy in the second half of 2006.
-- Data were presented in an oral session at the 13th Conference on
Retroviruses and Opportunistic Infections (CROI) from Sangamo's program
to develop a ZFP Therapeutic for the treatment of HIV/AIDS. The
preclinical data demonstrate that Sangamo's ZFP nuclease (ZFN(TM))
technology can be used to make cells resistant to HIV infection by
permanently modifying the DNA sequence encoding CCR5, an essential co-
receptor for the entry of HIV into immune cells. In addition, ZFN-
modified cells were able to grow in culture under conditions in which
they were exposed to HIV for prolonged periods. When CCR5 expression
was experimentally restored to the ZFN-modified cells, HIV was once
again able to infect them demonstrating the selectivity of the
approach. In the second half of 2006, Sangamo expects to initiate a
Phase 1 clinical trial to test this HIV ZFP Therapeutic.
-- Expansion of existing research collaboration agreement between Sangamo
and Pfizer Inc in the field of enhanced protein production. Under the
terms of the agreement, Pfizer will fund further research at Sangamo
and Sangamo will use its ZFP gene regulation and ZFN gene modification
technology to develop additional improved cell lines for enhanced
protein production.
-- Sangamo announced agreement to utilize MaxCyte's proprietary cell
loading system for use in Sangamo's HIV/CCR5 ZFP Therapeutic program.
The two companies have initiated a research and development plan to
evaluate and further develop the GMP-compliant MaxCyte system to load
ZFP-based therapeutics into cells. Sangamo also has the option to
utilize MaxCyte's system for ZFP Therapeutics in oncology. The
agreement provides Sangamo an option for a commercial license to
MaxCyte's technology that includes a supply contract and clinical and
commercial milestones to MaxCyte for products developed under the
agreement. Under the license, Sangamo has the right to reference
MaxCyte's FDA Master File in its regulatory submissions.
-- Preclinical animal efficacy data were published demonstrating the
potential utility of ZFP TFs as a new class of human therapeutics for
the treatment of severe late-stage peripheral artery disease (PAD).
This stage of PAD, known as critical limb ischemia (CLI), is a major
health issue that results in limb loss in a significant number of
patients around the world. The authors used an engineered ZFP TF
designed to activate the expression of the endogenous VEGF A gene. VEGF
A has been extensively documented as an important factor in
angiogenesis or blood vessel growth. Using a ZFP TF to increase the
expression of this gene and the protein that it encodes in ischemic
muscle resulted in statistically significant changes in treated limbs
in a number of measures of efficacy. These efficacy end-points
included: decreased gangrene of the limb and overall cell death in the
treated muscle, increased cell growth and increased blood vessel
density and blood flow. The study, reported in the January issue of the
FASEB Journal, was conducted in the laboratory of Frank Giordano, M.D.,
Assistant Professor of Medicine, Cardiovascular Medicine Department at
Yale University School of Medicine. Sangamo scientists developed the
VEGF ZFP Therapeutic under an agreement with Edwards Lifesciences.
Edwards is currently testing it in a Phase 1 human clinical trial for
CLI at the Duke University Medical Center. Edwards has stated that it
intends to initiate a Phase 2 trial for this indication in 2006.
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 programs are
currently in Phase I clinical trials for evaluation of safety in
patients with peripheral artery disease and diabetic neuropathy.
Other therapeutic development programs are focused on ischemic
heart disease, congestive heart failure, cancer, neuropathic
pain, and infectious 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
(ZFNs) for therapeutic gene modification as a treatment and
possible cure for a variety of monogenic diseases such as sickle
cell anemia and for infectious diseases such as HIV. Research at
Sangamo is partially funded by an Advanced Technology Program
(ATP) grant awarded by the National Institute of Standards and
Technology (NIST). For more information about Sangamo, visit the
company's web site at
www.sangamo.com or
www.expressinglife.com |