Exhibit 99.1
SANGAMO BIOSCIENCES REPORTS 2004 FOURTH QUARTER AND YEAR-END FINANCIAL RESULTS
RICHMOND, Calif., Feb. 16 /PRNewswire-FirstCall/ -- Sangamo BioSciences,
Inc. (Nasdaq: SGMO) today reported financial results for the fourth quarter
ended December 31, 2004. The consolidated net loss was $3.0 million, or $0.12
per share as compared to a net loss of $1.7 million, or $0.07 per share in the
same period in 2003. At December 31, 2004, the company had cash, cash
equivalents, and investments of $33.5 million.
Revenues for the fourth quarter of 2004 were $200,000 as compared to fourth
quarter 2003 revenues of $1.0 million. The principal components of fourth
quarter 2004 revenues were from Sangamo's partnerships in the areas of human
therapeutics, enabling technologies and government research grants. The decease
in revenues for the fourth quarter of 2004 compared with 2003 was principally
attributable to lower revenues recognized from our therapeutics partnership with
Edwards Lifesciences Corp. as a result of completion of our preclinical research
and Edwards' payments for those activities under the agreement.
Total fourth quarter 2004 operating expenses were $3.6 million as compared
to $3.0 million in the prior year period. Research and development expenses were
$2.5 million for each of the three months ended December 31, 2004 and 2003.
General and administrative expenses were $1.1 million for the fourth quarter of
2004 as compared to $553,000 for the same period in 2003. Increased general and
administrative expenses in 2004 reflect Sangamo's increased expenses associated
with compliance with Section 404 of the Sarbanes-Oxley Act and other
professional services.
Net interest income for the fourth quarter of 2004 was $164,000 as compared
to $162,000 in the comparable period of 2003.
Recent Highlights
* Sangamo submitted an investigational new drug application (IND) to the
U.S. Food and Drug Administration (FDA) for SB-509, a novel therapeutic designed
to protect and stimulate the regeneration of peripheral nerve function in
diabetics suffering from peripheral neuropathy. The IND is now open. SB-509 is
an injectable formulation of plasmid DNA that encodes a zinc finger DNA-binding
protein transcription factor (ZFP TF), designed to upregulate the vascular
endothelial growth factor A (VEGF-A) gene. VEGF A has been demonstrated to have
direct neurotrophic and neuroprotective properties. In preclinical animal
efficacy studies, SB-509 has proven effective in protecting motor and sensory
nerve function in a diabetic model and in stimulating nerve regeneration. A
multicenter Phase I human clinical trial is scheduled to begin in the first half
of 2005. It is a single-blind, dose- escalation study designed to evaluate
clinical safety of SB-509 in diabetics with mild to moderate diabetic peripheral
sensory motor neuropathy in the legs. Further information will be available on
our website http://www.sangamo.com/ as the trial centers become active and start
screening patients for enrollment.
* Sangamo entered into research collaborations with Pfizer Inc and Amgen
Inc. in the field of enhanced protein production. Sangamo will provide its
proprietary zinc finger DNA binding protein (ZFP) technology for Pfizer and
Amgen to assess its feasibility for use in enhancing mammalian cell-based
protein pharmaceutical production. Neither agreement includes a commercial
license.
* Sangamo appointed David Ichikawa as Senior Vice President, Business
Development. Mr. Ichikawa has responsibility for all licensing and business
development activities for the company and reports to Edward Lanphier, Sangamo's
president and chief executive officer. Mr. Ichikawa was most recently Chief
Business Officer for Sagres Discovery, where he was responsible for corporate
strategy and business development activities. He has more than 20 years of
industry experience with both pharmaceutical and biotechnology companies in
various commercial areas. Prior to Sagres Discovery, David held several
positions with Chiron Corporation including Vice President, R&D Business
Development and Finance.
* Sangamo's partner Edwards Lifesciences Corp. updated investors on plans
to pursue further clinical evaluations of a ZFP Therapeutic. At their analyst
day in December, 2004 Edwards stated that the success of the preclinical program
and data had attracted interest from several clinical centers that wanted to
conduct human clinical trials of the ZFP Therapeutic developed in partnership
with Sangamo BioSciences. A Phase I clinical trial is currently ongoing at the
Warren Grant Magnuson Clinical Center of the National Institutes of Health in
Bethesda Maryland for a ZFP TF designed to activate all isoforms of the natural
VEGF-A gene to stimulate angiogenesis, or new blood vessel growth. The study is
designed primarily to measure the ZFP Therapeutic's safety in treating
intermittent claudication, a symptom of peripheral artery disease (PAD).
Additional information about the trial can be found at
http://dir.nhlbi.nih.gov/labs/cb/cip/genetransfer.asp . Edwards also stated that
preclinical studies had been completed and that they expected to initiate a
second trial for PAD in the more severe form of critical limb ischemia in 2005
at Duke University. In addition, they stated that they expected to complete
preclinical studies in 2005 and, based upon these data, to initiate a human
clinical trial in post myocardial infarction ischemic heart disease at Yale
University School of Medicine.
* Sangamo announced the expansion of the existing research collaboration in
the area of regenerative medicine with LifeScan Inc., a Johnson & Johnson
company. The agreement provides LifeScan with Sangamo's proprietary zinc finger
DNA binding proteins (ZFPs) for use in a program to develop therapeutic cell
lines as a potential treatment for diabetes.
* Sangamo was granted a United States patent entitled "Regulation of
Endogenous Gene Expression in Cells Using Zinc Finger Proteins." The patent
covers the activation or repression of any endogenous gene, in any cell, in any
organism using engineered zinc finger DNA-binding proteins (ZFPs) and broadens
Sangamo's patent coverage of the uses of engineered ZFPs to include delivery of
ZFP Therapeutics as recombinant proteins.
* The World Economic Forum announced the selection of Sangamo BioSciences,
Inc. as a Technology Pioneer for 2005. Companies selected as Technology Pioneers
are recognized as developing and applying the most innovative and
transformational technologies at the forefront of cutting-edge work in fields
such as nanotechnology, drug development, renewable energy and wireless
technology with the potential to significantly impact the way business and
society operates.
Twelve Month Results
For the year ended December 31, 2004 the net loss was $13.8 million, or
$0.55 per share, compared to $10.4 million, or $0.42 per share for the year
ended December 31, 2003. Revenues for the year ended December 31, 2004 were $1.3
million as compared to $2.6 million in 2003. The decrease in revenues for 2004
compared with 2003 was principally attributable to lower revenues recognized
from our therapeutics partnership with Edwards Lifesciences Corp. as a result of
completion of our preclinical research and Edwards' payments for those
activities under the agreement. Total expenses for the years ended December 31,
2004 and 2003 were $16.0 million and $14.3 million, respectively.
At December 31, 2004, the company had cash, cash equivalents, and
investments of $33.5 million, compared with $44.3 million at December 31, 2003.
Total shares outstanding at December 31, 2004 were 25.3 million as compared to
25.0 million at December 31, 2003.
Conference Call
Sangamo will host a conference call today at 2:00 p.m. PST, which will be
open to the public. The call will also be webcast and can be accessed via a link
on the Sangamo BioSciences website in the Investor Relations section under
"Company Overview"
http://phx.corporate-ir.net/phoenix.zhtml?c=120938&p=irol-IRHome for up to two
weeks after the call. During the conference call, the company will review these
results, discuss other business matters, and provide forward-looking guidance
with respect to 2005.
The conference call dial-in numbers are 888-396-2369 for domestic callers
and 617-847-8710 for international callers. The passcode for the call is
94857563. 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 4:00 p.m. PST on February 16, 2005 to 9:00 p.m. PST on February
23, 2005. The conference call replay numbers for domestic and international
callers are 888-286-8010 and 617-801-6888, respectively. The conference ID
number for the replay is 62835232.
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 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 TFs) 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. For
more information about Sangamo, visit the company's web site at www.sangamo.com
or www.expressinglife.com
This press release contains forward-looking statements regarding Sangamo's
current expectations. 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
the early stage of ZFP Therapeutic development, uncertainties related to the
timing of initiation and completion of clinical trials, and whether clinical
trial results will validate and support the safety and efficacy of ZFP
Therapeutics. 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)
Three Months Ended Twelve Months Ended
December 31, December 31,
------------------------------ ------------------------------
2004 2003 2004 2003
------------- ------------- ------------- -------------
Condensed Consolidated Statement of
Operations Data:
Revenues $ 200 $ 1,003 $ 1,315 $ 2,579
Operating expenses:
Research and development 2,510 2,479 11,695 10,638
General and administrative 1,090 553 4,270 3,710
Total operating expenses 3,600 3,032 15,965 14,348
Loss from operations (3,400) (2,029) (14,650) (11,769)
Interest income, net 164 162 620 752
Other income 193 187 212 584
Net loss $ (3,043) $ (1,680) $ (13,818) $ (10,433)
Basic and diluted net loss per
common share $ (0.12) $ (0.07) $ (0.55) $ (0.42)
Shares used in computing basic and
diluted net loss per common share 25,226 24,907 25,126 24,811
CONDENSED CONSOLIDATED BALANCE SHEET DATA
Dec. 31, Dec. 31,
2004 2003
------------- -------------
Cash, cash equivalents, and
investments $ 33,520 $ 44,343
Total assets 34,725 46,232
Total stockholders' equity 32,377 44,661
SOURCE Sangamo BioSciences, Inc.
-0- 02/16/2005
/CONTACT: Elizabeth Wolffe, Ph.D. of Sangamo BioSciences, Inc.,
+1-510-970-6000, ext. 271, or ewolffe@sangamo.com; or media, Kathy Nugent,
+1-212-213-0006, or investors, John Cummings, +1-415-352-6262, both of Burns
McClellan, Inc., for Sangamo BioSciences, Inc./
/Web site: http://www.sangamo.com /