Sangamo BioSciences Reports First Quarter 2008 Financial Results
RICHMOND, Calif., April 30 /PRNewswire-FirstCall/ -- Sangamo BioSciences,
Inc. (Nasdaq: SGMO) today reported first quarter 2008 financial results and
accomplishments.
For the first quarter ended March 31, 2008, Sangamo reported a
consolidated net loss of $8.0 million, or $0.20 per share, compared to a net
loss of $5.4 million, or $0.15 per share, for the same period in 2007. As of
March 31, 2008, the company had cash, cash equivalents and short-term
investments of $73.6 million.
Revenues for the first quarter of 2008 were $2.8 million, compared to $1.4
million for the same period in 2007. First quarter 2008 revenues were primarily
from Sangamo's agreements with Dow AgroSciences and Sigma-Aldrich Corporation,
research grants and enabling technology agreements in protein production.
Research and development expenses were $8.6 million for the first quarter
of 2008, compared to $5.4 million for the same period in 2007. The increase in
R&D expenses is primarily related to advancing Sangamo's ZFP Therapeutic(TM)
clinical program in diabetic neuropathy and costs related to pre-IND programs in
HIV/AIDS and glioblastoma, as well as increased personnel and laboratory supply
expenses. Non-cash employee stock-based compensation included in research and
development expenses totaled $0.9 million and $0.3 million in the 2008 and 2007
periods, respectively.
General and administrative expenses were $2.9 million for the first
quarter of 2008, compared to $2.0 million for the corresponding 2007 period. The
increase in general and administrative expenses was primarily due to increased
personnel costs. Non-cash employee stock-based compensation included in general
and administrative expenses totaled $0.9 million and $0.2 million in the 2008
and 2007 periods, respectively.
Total operating expenses for the first quarter of 2008 were $11.6 million,
compared to $7.4 million for the same period in 2007.
Net interest and other income was $0.8 million for the first quarter of
2008, compared to $0.6 million for the same period in 2007, primarily due to
higher average cash and investment balances.
First Quarter 2008 Highlights
-- Initiation of a Phase 2 stem cell mobilization clinical trial. The
study is a randomized, single-blind, placebo-controlled,
multi-center Phase 2 clinical trial of SB-509 (SB-509-703) in
subjects with mild to moderate diabetic neuropathy (DN) and is
designed to evaluate the pharmacokinetics of stem cell mobilization
into the bloodstream after treatment. Circulating stem cells
observed post treatment with SB-509 are highly enriched in cell
types that mediate tissue repair. In addition, early data suggests
that SB-509 treatment may mobilize between 100 to 1000-fold more
cells than are typically being introduced into subjects in many of
the ex vivo stem cell therapeutic approaches that are currently
being tested. Ultimately, this phenomenon may also serve as a
pharmacodynamic surrogate biomarker enabling a physician to easily
monitor progress of this therapy for DN after SB-509 administration.
-- Entry into a second Research and License Agreement with Genentech,
Inc. and a new License Agreement with Open Monoclonal Technologies
(OMT). Sangamo's second agreement with Genentech is an expansion of
an earlier agreement and includes modification of additional targets
for potential improvement of production cell lines using our
proprietary zinc finger DNA-binding protein nuclease (ZFN)
technology. Sangamo also agreed to provide a non-exclusive,
worldwide license to OMT for the commercial use of transgenic
animals generated using our proprietary ZFN technology. OMT is
paying Sangamo an upfront license fee, payments upon the achievement
of certain clinical development and commercial milestones, a share
of payments received by OMT from sublicensees, and royalties on
sales of any products developed using Sangamo's ZFP technology.
-- Successful completion of a key research milestone as part of the
joint Research and Commercial License Agreement between Dow
AgroSciences LLC and Sangamo This milestone represents the
successful application of Sangamo's ZFN technology in precision
genome editing of a native plant gene with the aim of improving a
valuable trait in canola, a crop central to Dow AgroSciences'
business.
-- Presentation of positive preclinical animal data from Sangamo's ZFP
Therapeutic program for the treatment of glioblastoma multiforme
(GBM). Data were presented in the New Approaches to Biological
Therapy Session at the 2008 Annual Meeting of the American
Association for Cancer Research (AACR) by Sangamo's collaborator
Michael C.V. Jensen, M.D., Associate Chair, Division of Cancer
Immunotherapeutics & Tumor Immunology, City of Hope. The data
demonstrated that treatment of T-cells, engineered to kill
glioblastoma cells, with ZFNs specifically targeted to the
glucocorticoid receptor (GR) gene results in the knockout of the GR
gene creating glucocorticoid-resistant T-cells. These
zetakine-positive, GR-negative T-cells kill glioblastoma cells in
vitro. In addition, data were presented from a mouse model of GBM
demonstrating that these T-cells were capable of killing tumor cells
in the animal in the presence of the glucocorticoid dexamethasone.
-- Publication of data demonstrating the use of Sangamo's ZFN
technology in a new approach for rapid generation of "knock-out"
cell lines. Sigma-Aldrich Corporation and Sangamo announced the
publication of work which was carried out in collaboration with
scientists from Pfizer Inc and represents a significant advance in
the specificity and efficiency of the production of "knock-out" cell
lines. Such cell lines are powerful tools that are widely used in
research to identify a gene's function, in drug development to
screen potential drug candidates and for production of recombinant
proteins. The data were published in the Proceedings of the National
Academy of Sciences Early Edition online on March 21, 2008,
http://www.pnas.org/cgi/content/abstract/0800940105v1 ("Targeted
Gene Knockout in Mammalian Cells Using Engineered Zinc Finger
Nucleases") and in the print edition of the journal. Sigma-Aldrich
is Sangamo's exclusive licensee for this technology in the
laboratory research reagent field.
-- Nomination of Thomas G. Wiggans for election to Sangamo's Board of
Directors. Mr. Wiggans was most recently the Chief Executive Officer
of Connetics Corporation from 1994, and Chairman of the Board from
January 2006, until December 2006 when Connetics Corporation was
acquired by Stiefel Laboratories, Inc. He has extensive senior
management experience in the biotechnology industry in executive and
board positions with a number of life sciences companies. He will
stand for election by shareholders, along with other board members
standing for re-election, at Sangamo's Annual Meeting which will be
held at 9:00 a.m. (PT) on Wednesday, June 4, 2008 at Sangamo's
headquarters in Richmond, California.
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 forward-looking guidance.
The conference call dial-in numbers are 877-675-4749 for domestic callers
and 719-325-4940 for international callers. The passcode for the call is
6274211. 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 April 30, 2008 to 11:59 p.m. ET on May 7, 2008.
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 6274211.
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. Phase 1 clinical trials are ongoing to evaluate a ZFP
Therapeutic for peripheral artery disease. 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 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 with collaborators and anticipated amount of cash and cash
equivalents. 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 FINANCIAL DATA
(in thousands, except per share data)
(unaudited)
Quarter Ended March 31,
2008 2007
Consolidated Statement of Operations Data:
Total revenues $ 2,765 $ 1,422
Operating expenses:
Research and development 8,646 5,430
General and administrative 2,927 1,999
Total operating expenses 11,573 7,429
Loss from operations (8,808) (6,007)
Interest and other income, net 836 648
Net loss $ (7,972) $ (5,359)
Basic and diluted net loss per common share $ (0.20) $ (0.15)
Shares used in computing basic and diluted net
loss per common share 40,489 35,057
March 31, December 31,
2008 2007
(Unaudited)
CONSOLIDATED CONDENSED BALANCE SHEET DATA
Cash, cash equivalents and short-term
investments $ 73,579 $ 81,412
Total assets 76,742 83,900
Total stockholders' equity 66,457 72,122
SOURCE Sangamo BioSciences, Inc.