Sangamo BioSciences Reports Second Quarter 2014 Financial Results
RICHMOND, Calif., July 23, 2014
RICHMOND, Calif., July 23, 2014 /PRNewswire/ --Sangamo BioSciences, Inc.
(NASDAQ: SGMO) today reported its second quarter 2014 financial results and
Sangamo BioSciences, Inc.
For the second quarter ended June 30, 2014, Sangamo reported a consolidated
net loss of $7.0 million, or $0.10 per share, compared to a net loss of $5.5
million, or $0.10 per share, for the same period in 2013. As of June 30, 2014,
the Company had cash, cash equivalents, marketable securities and interest
receivable of $236.7 million.
Revenues for the second quarter of 2014 were $10.4 million, compared to $6.9
million for the same period in 2013. Second quarter 2014 revenues were
generated from the Company's collaboration agreements with Shire International
GmbH (Shire), Biogen Idec (Biogen), enabling technology agreements and
research grants. The revenues recognized for the second quarter of 2014
consisted of $9.7 million in collaboration agreements and $0.7 million in
research grants, compared to $6.2 million and approximately $0.8 million,
respectively, for the same period in 2013.
The increase in collaboration agreement revenues was primarily due to an
increase in revenues under the Company's collaboration and license agreements
with Shire and Biogen. In the second quarter of 2014, Sangamo recognized
approximately $5.9 million of revenues related to research services performed
under the collaboration agreement with Shire, and $1.3 million of revenues
related to research services performed under the collaboration agreement with
Biogen. In addition, pursuant to the agreements entered into with Shire in
January 2012 and Biogen in January 2014, Sangamo received upfront payments of
$13.0 million and $20.0 million, respectively. These payments are being
recognized on a straight-line basis over the initial six-year research term
for Shire and approximately 40 months for Biogen. The Company recognized $0.5
million of the Shire upfront payment and $1.5 million of the Biogen upfront
payment as revenue for the second quarter of 2014.
Research and development expenses were $13.4 million for the second quarter of
2014, compared to $9.3 million for the same period in 2013. The increase in
research and development expenses was primarily due to increases in external
research expenses associated with our preclinical programs and
personnel-related expenses, including stock-based compensation. General and
administrative expenses were $4.0 million for the second quarter of 2014,
compared to $3.1 million for the same period in 2013.
Total operating expenses for the second quarter of 2014 were $17.4 million,
compared to $12.4 million for the same period in 2013.
Six Months Results
For the six months ended June 30, 2014, the consolidated net loss was $14.6
million, or $0.22 per share, compared to a consolidated net loss of $12.3
million, or $0.23 per share, for the six months ended June 30, 2013. Revenues
were $18.5 million for the first half of 2014, compared to $11.6 million for
the same period in 2013. Total operating expenses were $33.2 million for the
first half of 2014, compared to $23.9 million for the first half of 2013.
oSangamo BioSciences and City of Hope were granted a Strategic Partnership
Award from California Institute for Regenerative Medicine (CIRM) to
support a Phase 1 clinical trial of Sangamo's HIV/AIDS stem-cell program.
In May 2014, CIRM granted a $5.6 million Strategic Partnership Award to
fund clinical studies at City of Hope to develop a ZFP Therapeutic for
HIV/AIDS based on the application of Sangamo's zinc finger nuclease (ZFN)
genome-editing technology in hematopoietic stem/progenitor cells (HSPCs).
The four-year grant provides matching funds to support a Phase 1,
open-label study to evaluate the safety and tolerability, feasibility, and
engraftment of ZFN CCR5-modified autologous CD34+ HSPCs in immunologic
non-responders, a population of HIV-1 infected individuals who have
suboptimal CD4 levels despite having levels of virus that are well
controlled by anti-retroviral therapy (ART). ZFN genome-editing technology
has already been successfully used to generate CCR5-modified autologous
CD4 T-cells (SB-728-T) and demonstrated patient safety and tolerability in
HIV-1 infected subjects. Sangamo has an ongoing Phase 2 clinical trial of
SB-728-T which is designed to evaluate enhancement of engraftment of
ZFN-modified cells using an optimal dose of Cytoxan preconditioning and
certain improvements in process development.
oPresentation of clinical update on subjects in SB-728-T program and
progress in other therapeutic and research programs at the Annual Meeting
of the American Society of Gene and Cell Therapy (ASGCT). Dale Ando, M.D.,
Sangamo's vice president of therapeutic development and chief medical
officer, presented an update on subjects in the completed clinical trials
of SB-728-T for HIV/AIDS, at the 17th Annual ASGCT Meeting held in May
2014. He reported that one subject, enrolled in the SB-728-902 Cohort 5
study, demonstratedcontinuing control of circulating viral load at low
levels for 45 weeks of a treatment interruption (TI) of their ART. The
subject has now sustained control of viral load for over one year. A
second subject, enrolled in the SB-728-1101 Cytoxan pre-conditioning study
at the 1 g/m^2 dose, has experienced a greater than two-log sustained
decrease in circulating viral load from peak during TI for over 34 weeks.
Both subjects remain off ART. The Company also outlined other data from
preclinical and research-stage programs focused on the development of ZFP
Therapeutics^®, including Huntington's disease and research-stage
collaborations in other monogenic diseases, cancer immunotherapy and
advancements in the technology.
oPublication of preclinical data demonstrating gene correction in SCID-X1
HPSCs in Nature. In May 2014, Nature published a study entitled "Targeted
genome-editing in human repopulating haematopoietic stem cells" authored
by Sangamo scientists and collaborators. The data demonstrated methods for
efficient ZFN-mediated, targeted gene insertion that resulted in
correction of the genetic defect in HPSCs from an individual with X-linked
severe combined immunodeficiency (SCID-X1). Importantly, the study
demonstrates that the treatment successfully targets a class of HSPCs that
are responsible for the long term repopulation of the bone marrow
following transplant. The data support the clinical translation of this
approach for SCID-X1, other immunodeficiencies and monogenic diseases.
oAppointment of H. Stewart Parker to the Board of Directors. In June,
Sangamo appointed H. Stewart Parker to its board of directors. Ms. Parker,
who founded and served as President and CEO of Targeted Genetics
Corporation, brings more than 30 years of experience in the biotechnology
industry, including 16 years of specific experience in cell and gene
oAppointment of Vice President of Manufacturing, Stewart Craig, Ph.D. Dr.
Craig, who joined Sangamo in May 2014, has 30 years of experience in the
biotechnology industry, specifically in the research, development,
manufacture and regulation of biotherapeutics including both gene and
cell-based therapies. He has held executive roles leading and developing
GMP manufacturing operations and facilities including overseeing the
design, construction and validation of a number of GMP manufacturing
facilities. Dr. Craig will be responsible for overseeing the manufacturing
of all biotherapeutics for the Company.
Financial Guidance for 2014
The Company reiterates its earlier guidance as follows:
oCash and Investments: Sangamo expects that its cash, cash equivalents and
marketable securities will be at least $225 million at the end of 2014,
inclusive of research funding and certain milestone payments from Shire
and Biogen but exclusive of funds arising from any additional new
collaborations or partnerships, equity financings or other new sources.
oRevenues: Sangamo expects that revenues will be in the range of $45
million to $50 million in 2014, inclusive of research funding and certain
milestone payments from Shire and Biogen.
oOperating Expenses: Sangamo expects that operating expenses will be in the
range of $65 million to $70 million for
Sangamo will host a conference call today, July 23, 2014, 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. A replay of the webcast 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
guidance with respect to the rest of 2014.
The conference call dial-in numbers are (877) 377-7553 for domestic callers
and (678) 894-3968 for international callers. The conference ID number for the
call is 69820610. 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 July 23, 2014 to 11:59 p.m. ET on
July 30, 2014. The conference call replay numbers for domestic and
international callers are (855) 859-2056 and (404) 537-3406, respectively. The
conference ID number for the replay is 69820610.
Sangamo BioSciences, Inc. is focused on Engineering Genetic Cures^TM for
monogenic and infectious diseases by deploying its novel DNA-binding protein
technology platform in therapeutic gene regulation and genome editing. The
Company has ongoing Phase 2 clinical trials to evaluate the safety and
efficacy of a novel ZFP Therapeutic^® for the treatment of HIV/AIDS (SB-728-T)
and NGF-AAV for Alzheimers disease (CERE-110). Sangamo's other therapeutic
programs are focused on monogenic and rare diseases. The Company has formed a
strategic collaboration with Shire International GmbH to develop therapeutics
for hemophilia, Huntington's disease and other monogenic diseases, and with
Biogen Idec for hemoglobinopathies, such as sickle cell disease and
beta-thalassemia. It has also 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 website at www.sangamo.com.
ZFP Therapeutic^® is a registered trademark of Sangamo BioSciences, Inc.
This press release contains forward-looking statements regarding Sangamo's
current expectations. These forward looking statements include, without
limitation, references to anticipated cash and investment balance, operating
expenses, revenue and potential milestone and royalty payments, the research
and development of ZFNs and ZFP TFs, clinical trials and therapeutic
applications of Sangamo's ZFP technology platform, revenue recognition and
achievement of research milestones and objectives under collaboration
agreements with Shire and Biogen, and enrollment of subjects in clinical
trials. 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, the lengthy
and uncertain regulatory approval process, 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 and its partners 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
Sangamo's operations and business environments. These risks and uncertainties
are described more fully in Sangamo'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 Sangamo undertakes no duty to update such information
except as required under applicable law.
SELECTED CONSOLIDATED FINANCIAL DATA
(in thousands, except per
Three Months Ended Six Months Ended
June 30, June 30,
2014 2013 2014 2013
Statement of Operations Data:
Collaboration agreements $ 9,721 $ $ 17,289 $ 10,240
Research grants 664 777 1,212 1,317
Total revenues 10,385 6,934 18,501 11,557
Research and development 13,430 9,278 25,463 17,498
General and administrative 3,972 3,124 7,616 6,432
Change in fair value of 30 - 80 -
Total operating expenses 17,432 12,402 33,159 23,930
Loss from operations (7,047) (5,468) (14,658) (12,373)
Interest and other income, 66 18 105 38
Net loss $ (6,981) $ $ (14,553) $ (12,335)
Basic and diluted net loss $ $ $ $
per common share (0.10) (0.10) (0.22) (0.23)
Shares used in computing
basic and diluted net loss 67,980 53,786 65,603 53,583
per common share
SELECTED BALANCE SHEET DATA
June 30, 2014 December 31, 2013
Cash, cash equivalents, marketable securities $ 236,708 $
and interest receivable 131,814
Total assets 250,837 140,838
Total stockholders' equity 214,357 121,710
Logo - http://photos.prnewswire.com/prnh/20130102/SF35903LOGO
SOURCE Sangamo BioSciences, Inc.
Contact: Sangamo BioSciences, Inc., Elizabeth Wolffe, Ph.D., (510) 970-6000,
x271, or Varant Shirvanian, (510) 970-6000, x205
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