RICHMOND, Calif., Nov. 4 /PRNewswire-FirstCall/ -- Sangamo BioSciences, Inc.
(Nasdaq: SGMO) today reported third quarter 2009 financial results and
accomplishments.
For the third quarter ended September 30, 2009, Sangamo reported a
consolidated net loss of $4.9 million, or $0.12 per share, compared to a
consolidated net loss of $6.3 million, or $0.15 per share, for the same period
in 2008. As of September 30, 2009, the company had cash, cash equivalents,
marketable securities and interest receivable of $47.9 million. In October
2009, Sangamo completed an underwritten public offering that resulted in net
proceeds of $20.9 million to the company and entered into an expanded
agreement with Sigma-Aldrich Corporation under the terms of which Sigma made
initial payments of $20.0 million to Sangamo.
Revenues for the third quarter of 2009 were $4.1 million, compared to $3.7
million for the same period in 2008. Third quarter 2009 revenues were from the
Company's collaboration agreements with Dow AgroSciences and Sigma-Aldrich
Corporation, enabling technology agreements in protein production and research
grants. The revenue recognized for the third quarter of 2009 consisted of $4.0
million in collaboration agreements and $51,000 in research grants.
Research and development expenses were $6.2 million for the third quarter of
2009, compared to $7.6 million for the same period in 2008. The decrease in
research and development expenses for the third quarter of 2009 was primarily
due to decreased manufacturing, preclinical, licensing and consulting expenses
partially offset by increased stock based compensation expenses. Non-cash
employee stock-based compensation included in research and development
expenses totaled $0.8 million for the third quarter of 2009 compared to $0.6
million for the same period in 2008.
General and administrative expenses were $2.7 million for the third quarter of
2009, compared to $2.6 million for the same period in 2008. The increase in
general and administrative expenses was primarily due to increased personnel
costs, including non-cash employee stock-based compensation, which totaled
$0.9 million in the third quarter of 2009 compared to $0.7 million in the same
period in 2008.
Total operating expenses for the third quarter of 2009 were $8.9 million,
compared to $10.1 million for the same period in 2008.
Net interest and other income (loss) were recorded as a net loss of $47,000
for the third quarter of 2009 compared to income of $42,000 for the same
period in 2008.
Nine Month Results
For the nine months ended September 30, 2009, the consolidated net loss was
$16.2 million, or $0.39 per share, compared to a consolidated net loss of
$21.7 million, or $0.53 per share, for the nine-months ended September 30,
2008. Revenues were $11.9 million for the nine months ended September 30,
2009, compared to $9.4 million for the same period in 2008. Total operating
expenses were $28.9 million for the nine months ended September 30, 2009,
compared to $32.5 million for the same period in 2008. The decrease in
operating expenses for 2009 was primarily associated with decreased
manufacturing, preclinical, consulting and lab supply expenses.
Recent Highlights
-- Presentation of top-line statistically significant Phase 2 ZFP
Therapeutic(TM) data at the Society for Neuroscience Meeting. Sangamo
presented top-line, statistically significant Phase 2 clinical data
from
its zinc finger DNA-binding protein (ZFP) Therapeutic program to
develop
SB-509 for treatment of diabetic neuropathy (DN) at the Society for
Neuroscience Annual Meeting held in Chicago. The data demonstrated a
direct neuroregenerative effect of SB-509 treatment that resulted in a
statistically significant (p value=0.02) increase in small
unmyelinated
nerve fibers in the skin, or intraepidermal nerve fiber density
(IENFD),
in subjects with DN. Data were also presented that provided
additional
evidence of the positive effect of SB-509 on large fiber sensory nerve
health as measured by improvements in nerve conduction velocity (NCV),
in subjects with elevated markers of vascular damage (ICAM-1), and
improvements in the muscle components of the neurologic exam (NIS-LL)
30-days after each of the three administrations of SB-509. Together
these data confirm the neuroregenerative activity of SB-509 in
patients
with DN and define a drug-responsive population for future trials.
-- Completion of an underwritten public offering. On October 13, 2009,
Sangamo closed an underwritten public offering of 3,000,000 shares of
its common stock at a public offering price of $7.20 per share
resulting
in net proceeds of approximately $20.9 million after deduction of
underwriting discounts and commissions and other offering expenses.
-- Expansion of licensing agreement with Sigma-Aldrich. Sigma-Aldrich
Corporation and Sangamo announced a major expansion of our existing
license agreement to include the exclusive rights to develop and
distribute ZFP-modified cell lines for commercial production of
protein
pharmaceuticals. Under the expanded agreement, Sigma also obtained
rights to certain ZFP-engineered transgenic animals for commercial
applications. Under the terms of the agreement, Sigma made initial
payments of $20.0 million to Sangamo, consisting of an upfront license
fee of $15.0 million and $5.0 million through the purchase of
Sangamo's
common stock at $7.86 per share. Sangamo is eligible to earn
additional
contingent commercial license fees of up to $5.0 million based on
certain conditions and thereafter a royalty based upon a percentage of
net sales and sublicensing revenue. Sangamo is also eligible to
receive
commercial milestone payments ranging from $2.0 million to $10.0
million, up to a total of $25.0 million, based upon cumulative product
sales.
-- Announcement of a second Phase 1 clinical trial of SB-728-T for the
treatment of HIV/AIDS. In September 2009, Sangamo announced the
successful review and acceptance by the FDA of an Investigational New
Drug (IND) application to initiate an open-label, repeat-dosing Phase
1
clinical trial (SB-728-T-902) of the company's ZFP nuclease
(ZFN)-based
therapeutic, SB-728-T. A single dose Phase 1 clinical study of
SB-728-T
was initiated in February 2009 and is ongoing at the University of
Pennsylvania. Both Phase 1 studies are designed primarily to evaluate
the safety and tolerability of this ZFP Therapeutic approach. However,
subjects' CD4 T-cell counts, levels of CCR5-modified T-cells and viral
burden will also be monitored.
-- Publication of ground-breaking new ZFN-mediated gene editing
applications in stem cells. Scientists from The Whitehead Institute
led
by Dr. Rudolf Jaenisch used ZFNs designed by Sangamo to efficiently
and
precisely modify the genomes of human embryonic stem cells (hESCs) and
induced pluripotent stem cells (hiPSCs). Human ESCs and iPSCs are
useful
tools in drug discovery and development. Scientists also hope to use
these cells therapeutically in transplantation medicine and other
regenerative applications. The research was described in a paper
published in the scientific journal Nature Biotechnology (Nat
Biotechnol. 2009 Sep; 27(9):851-7).
-- Sangamo's collaborators awarded significant clinical research awards
to
advance research into potential ZFP Therapeutics. Sangamo's
collaborators at the City of Hope and University of Southern
California
were awarded a $14.5 million grant from the California Institute of
Regenerative Medicine (CIRM). The grant will support the development
of
a ZFN-based stem cell therapy for HIV/AIDS. In addition, research led
by Donald B. Kohn, M.D., Director of the UCLA Human Gene Medicine
Program and member of the Broad Stem Cell Research Center, and Philip
Gregory, D. Phil., Sangamo's chief scientific officer and vice
president, research, was selected to receive an Innovations in
Clinical
Research Award of $486,000 from the Doris Duke Charitable Foundation.
The grant will support an innovative research project conducted by Dr.
Kohn and Sangamo scientists and titled "Beta-globin Gene Correction in
Hematopoietic Stem Cells for Sickle Cell Disease."
Conference Call
Sangamo will host a conference call today, November 4, 2009 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 and accomplishments, discuss other business
matters, and provide forward-looking guidance with respect to the remainder of
2009.
The conference call dial-in numbers are 877-879-6209 for domestic callers and
719-325-4830 for international callers. The passcode for the call is 4978837.
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 November 4, 2009 to midnight ET on November 11,
2009. 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 4978837.
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 and ALS. Sangamo also has two Phase 1 clinical trials to
evaluate safety and clinical effect of a ZFP Therapeutic for the treatment of
HIV/AIDS. Other therapeutic development programs are focused on cancer,
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) that can control gene expression and,
consequently, cell function. Sangamo is also developing sequence-specific ZFP
Nucleases (ZFN) 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 of SB-509 and SB-728-T, therapeutic and non-therapeutic
applications of Sangamo's ZFP technology platform, eligibility to receive
royalty and milestone payments under the Sigma agreement, 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
ZFP-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 Sangamo's Annual Report 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 CONSOLIDATED FINANCIAL DATA
(in thousands, except per share data)
(unaudited)
STATEMENT OF OPERATIONS DATA:
Three Months Ended Nine Months Ended
September 30, September 30,
---------------- ----------------
2009 2008 2009 2008
---- ---- ---- ----
Revenues
Collaboration agreements $4,012 $3,196 $11,382 $7,658
Research grants 51 549 564 1,694
-- --- --- -----
Total revenues 4,063 3,745 11,946 9,352
Operating expenses:
Research and development 6,166 7,563 20,299 24,492
General and administrative 2,701 2,564 8,634 8,036
Total operating expenses 8,867 10,127 28,933 32,528
----- ------ ------ ------
Loss from operations (4,804) (6,382) (16,987) (23,176)
Interest and other income
(loss), net (47) 42 793 1,448
Net loss $(4,851) $(6,340) $(16,194) $(21,728)
======= ======= ======== ========
Basic and diluted net loss
per common share $(0.12) $(0.15) $(0.39) $(0.53)
Shares used in computing basic
and diluted net loss per
common share 41,184 40,928 41,126 40,759
====== ====== ====== ======
SELECTED BALANCE SHEET DATA
September 30, 2009 December 31, 2008
------------------ -----------------
Cash, cash equivalents,
marketable securities
and interest receivable $47,863 $65,025
Total assets 51,383 67,850
Total stockholders' equity 44,450 55,396
SOURCE Sangamo BioSciences, Inc.
Elizabeth Wolffe, Ph.D. of Sangamo BioSciences, Inc., +1-510-970-6000, ext.
271
