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| 8-K - SANGAMO THERAPEUTICS, INC | v164719_8k.htm |
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Sangamo
BioSciences, Inc.
Point
Richmond Tech Center
501
Canal Boulevard
Richmond,
CA 94804
510-970-6000
l
510-236-8951(Fax)
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SANGAMO
BIOSCIENCES REPORTS THIRD QUARTER 2009
FINANCIAL
RESULTS
Richmond, California –
November 4, 2009 – 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
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·
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Presentation of top-line
statistically significant Phase 2 ZFP TherapeuticTM 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.
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·
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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.
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·
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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.
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·
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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.
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·
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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).
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·
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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 “Βeta-globin Gene Correction in Hematopoietic Stem Cells for
Sickle Cell Disease.”
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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 TherapeuticTM
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:
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Three
Months Ended
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Nine
Months Ended
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September
30,
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September
30,
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2009
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2008
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2009
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2008
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Revenues
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Collaboration
agreements
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$ | 4,012 | $ | 3,196 | $ | 11,382 | $ | 7,658 | ||||||||
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Research
grants
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51 | 549 | 564 | 1,694 | ||||||||||||
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Total
revenues
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4,063 | 3,745 | 11,946 | 9,352 | ||||||||||||
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Operating
expenses:
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Research
and development
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6,166 | 7,563 | 20,299 | 24,492 | ||||||||||||
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General
and administrative
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2,701 | 2,564 | 8,634 | 8,036 | ||||||||||||
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Total
operating expenses
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8,867 | 10,127 | 28,933 | 32,528 | ||||||||||||
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Loss
from operations
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(4,804 | ) | (6,382 | ) | (16,987 | ) | (23,176 | ) | ||||||||
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Interest
and other income (loss), net
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(47 | ) | 42 | 793 | 1,448 | |||||||||||
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Net
loss
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$ | (4,851 | ) | $ | (6,340 | ) | $ | (16,194 | ) | $ | (21,728 | ) | ||||
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Basic
and diluted net loss per common share
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$ | (0.12 | ) | $ | (0.15 | ) | $ | (0.39 | ) | $ | (0.53 | ) | ||||
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Shares
used in computing basic and diluted net loss per common
share
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41,184 | 40,928 | 41,126 | 40,759 | ||||||||||||
SELECTED
BALANCE SHEET DATA
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September 30, 2009
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December 31, 2008
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|||||||
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Cash,
cash equivalents, marketable securities and interest
receivable
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$ | 47,863 | $ | 65,025 | ||||
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Total
assets
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51,383 | 67,850 | ||||||
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Total
stockholders' equity
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44,450 | 55,396 | ||||||
CONTACT: Elizabeth Wolffe, Ph.D.
of Sangamo
BioSciences,
Inc. ,
+1-510-970-6000, ext. 271
###