BRISBANE, Calif., Feb. 28, 2019 /PRNewswire/ -- Sangamo
Therapeutics, Inc. (NASDAQ: SGMO), a genomic medicine company,
today reported fourth quarter and full year 2018 financial results
and recent business highlights.
Recent Highlights
- ST-920 IND acceptance: The U.S. Food and Drug
Administration (FDA) accepted the Investigational New Drug
application (IND) for ST-920, a gene therapy candidate being
evaluated for the treatment of adults with Fabry disease. Sangamo
expects to initiate the Phase 1/2 clinical trial evaluating ST-920
later this year.
- WORLDSymposium presentations: At the
WORLDSymposium earlier in February, Sangamo presented
interim results from the Phase 1/2 CHAMPIONS and EMPOWERS studies
evaluating SB-913 and SB-318, zinc finger nuclease (ZFN) in
vivo genome editing product candidates for the treatment of
Mucopolysaccharidosis Type II (MPS II) and MPS I, respectively.
Sangamo believes data from these two studies provide complementary
evidence supportive of a favorable safety profile and of the
activity of the ZFN in vivo genome editing approach used in
both SB-913 and SB-318.
- EVP of R&D appointment: Sangamo appointed
Adrian Woolfson, BM BCh, PhD, as
Executive Vice President of Research and Development.
- Completion of acquisition of TxCell: In the fourth
quarter of 2018, Sangamo completed the acquisition of TxCell, SA.
The acquisition positions Sangamo as a leader in the development of
CAR-Tregs, which the Company plans to evaluate for solid organ
transplant rejection and for autoimmune diseases.
"The enrollment of patients last year into our five active
clinical trials has laid the foundation for a steady flow of data
readouts in 2019," said Sandy
Macrae, CEO of Sangamo. "In the remainder of the year, we
anticipate providing important data that will help us understand
the potential clinical benefit of our MPS I and MPS II programs, as
well as clinical results and analyses from three clinical
hematology assets for hemophilia A, hemophilia B and beta
thalassemia. We also expect four additional programs to progress
into clinical development, including our wholly owned gene therapy
for Fabry disease and CAR-Treg therapy for the prevention of solid
organ transplant rejection, as well as partnered programs in sickle
cell disease and oncology being developed in collaboration with
Sanofi and Kite, respectively. I'm excited for what lies ahead as
we continue to push forward the development of our genomic
medicines."
Anticipated Milestones in 2019
In Vivo Genome Editing
- SB-913: Nine patients are enrolled in the CHAMPIONS Study
evaluating SB-913 for MPS II, including three patients who recently
entered the study in the expanded high-dose cohort. In 2019,
Sangamo expects to report longer-term safety and biochemical
measurements, as well as analyses of liver biopsies and enzyme
replacement therapy withdrawal experience.
- SB-318: Three patients are enrolled in the EMPOWERS Study
evaluating SB-318 for MPS I. In
2019, Sangamo expects to report longer-term safety and biochemical
measurements, as well as analyses of liver biopsies and enzyme
replacement therapy withdrawal experience.
- SB-FIX: One patient is currently enrolled in the FIXtendz Study
evaluating SB-FIX for hemophilia B. Sangamo expects to enroll a
second subject in the study and later in 2019 to report data
including safety and factor expression levels.
- Second-generation reagents for in vivo genome editing
platform: Sangamo has developed second-generation albumin locus ZFN
constructs for potential use in the ongoing in vivo genome
editing development programs. The Company plans to initiate a
clinical trial this year using these second-generation ZFNs that
should enable a Phase 3 decision for the MPS II program in
2020.
Gene Therapy
- SB-525: Eight patients are enrolled in the Alta Study
evaluating SB-525 gene therapy for hemophilia A, being developed in
collaboration with Pfizer. In 2019, Sangamo expects to report data
including safety and factor expression levels, as well as
information regarding factor replacement use and bleeding
events.
- ST-920: In 2019, Sangamo anticipates activating sites for the
Phase 1/2 clinical trial evaluating ST-920 gene therapy for the
treatment of Fabry disease.
Ex Vivo Cell Therapy
- ST-400 and BIVV003: ST-400 and BIVV003 are gene-edited cell
therapies being developed in collaboration with Sanofi for the
treatment of beta thalassemia and sickle cell disease. Sangamo has
enrolled two patients in the Thales Study evaluating ST-400 for the
treatment of beta thalassemia and in 2019 expects to report initial
safety and efficacy data including levels of fetal hemoglobin and
total hemoglobin. BIVV003 is being evaluated for the treatment of
sickle cell disease in the Phase 1/2 PRECIZN-1 trial run by
Sanofi.
- TX200: In 2019, Sangamo anticipates filing a clinical trial
application in Europe for TX200,
an autologous CAR-Treg cell therapy for the prevention of solid
organ transplant rejection. The Company expects to activate
clinical sites by year-end.
- KITE-037: Kite, a Gilead Company, has announced the intention
to file an IND for KITE-037, an allogeneic anti-CD19 CAR-T cell
therapy, in the latter half of 2019.
Fourth Quarter 2018 Financial Results
For the fourth quarter ended December 31,
2018, Sangamo reported a consolidated net loss of
$18.7 million, or $0.18 per share, compared to a net loss of
$13.1 million, or $0.15 per share, for the same period in 2017. As
of December 31, 2018, the Company had
cash, cash equivalents, marketable securities and interest
receivable of $400.5 million.
Revenues for the fourth quarter ended December 31, 2018 were $26.8 million, compared to $13.1 million for the same period in
2017. The increase came primarily from approximately
$11.5 million in revenues related to
the collaboration agreements with Pfizer for hemophilia A, and
$9.0 million in revenues related to
the collaboration with Kite, a Gilead Company, which included
reimbursement of $2.7 million in
research services. Fourth quarter 2018 revenues were primarily
generated from Sangamo's collaboration agreements with Pfizer,
Kite, Sanofi, and Dow Agrosciences.
Total operating expenses for the fourth quarter ended
December 31, 2018 were $47.6 million, compared to $26.8 million for the same period in 2017.
Research and development expenses were $33.3
million for the fourth quarter of 2018, compared to
$19.4 million for the same period in
2017. The increase was primarily due to manufacturing and clinical
trial expenses related to the progress of the Company's clinical
development programs. General and administrative expenses were
$14.4 million for the fourth quarter
of 2018, compared to $7.5 million for
the same period in 2017. This increase was primarily due to
increased headcount in general support of growth for the Company's
pipeline and clinical programs.
Full Year 2018 Results
For the year ended December 31, 2018,
the consolidated net loss was $68.3
million, or $0.70 per share,
compared to a consolidated net loss of $54.6
million, or $0.70 per share,
for the year ended December 31, 2017.
Revenues were $84.5 million for the
year ended December 31, 2018,
compared to $36.6 million for the
same period in 2017. The increase in revenues was primarily related
to our collaboration and license agreements with Kite and Pfizer.
Total operating expenses were $161.6
million for the year ended December
31, 2018, compared to $92.9
million for the same period in 2017. The increase in
operating expenses was primarily related to overall Company growth
and manufacturing and R&D expenses related to the advancement
of Sangamo's therapeutic pipeline.
Financial Guidance for 2019
- Operating Expense: Sangamo expects operating
expense of $210 to 220 million for
the year ending December 31,
2019.
- Cash and Investments: Sangamo projects that current
cash, cash equivalents, marketable securities and interest
receivable position should last at least two years.
Conference Call
Sangamo will host a conference call today, February 28, 2019, at 5:00
p.m. Eastern Time, which will be open to the public. The
call will also be webcast live and can be accessed via a link on
the Sangamo Therapeutics website in the Investors and Media section
under Events and Presentations.
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 6875578. 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
February 28, 2019 to 11:59 p.m. ET on March 7,
2019. 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
6875578.
About Sangamo Therapeutics
Sangamo Therapeutics, Inc. is focused on translating
ground-breaking science into genomic medicines with the potential
to transform patients' lives using the Company's platform
technologies in genome editing, gene therapy, gene regulation and
cell therapy. For more information about Sangamo, visit
www.sangamo.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding
Sangamo's current expectations. These forward-looking statements
include, without limitation, statements regarding the initiation of
clinical trials and activation of clinical trial sites in 2019, the
expected disease targets for our product candidates, the
presentation of clinical trial data from clinical trials in 2019,
enrollment expectations in 2019, the filing of a clinical trial
application in the European Union, and Sangamo's 2019 financial
guidance related to cash, cash equivalents, marketable securities
and interest receivable and operating expense. 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 dependence on the success of clinical trials,
the lengthy and uncertain regulatory approval process,
uncertainties related to the initiation, enrollment and completion
of clinical trials, whether the final results from a study will
validate and support interim safety and efficacy data, Sangamo's
reliance on partners and other third-parties to meet their clinical
and manufacturing obligations, and the ability to maintain
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 product
candidates. 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
Quarterly Report on Form 10-Q for the quarter ended September 30, 2018 as filed with the Securities
and Exchange Commission and Sangamo's Annual Report on Form 10-K
that it intends to file this week. 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
|
(unaudited; in
thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Statement of
Operations Data:
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
For the Year
Ended
|
|
December
31,
|
|
December
31,
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
Collaboration
agreements
|
$
26,687
|
|
$
12,918
|
|
$
84,065
|
|
$
35,960
|
Research
grants
|
150
|
|
159
|
|
387
|
|
607
|
Total revenues
|
26,837
|
|
13,077
|
|
84,452
|
|
36,567
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
33,254
|
|
19,377
|
|
114,866
|
|
65,728
|
General and
administrative
|
14,355
|
|
7,466
|
|
46,736
|
|
27,200
|
Total
operating expenses
|
47,609
|
|
26,843
|
|
161,602
|
|
92,928
|
Loss from
operations
|
(20,772)
|
|
(13,766)
|
|
(77,150)
|
|
(56,361)
|
Interest and other
income, net
|
1,553
|
|
675
|
|
8,261
|
|
1,793
|
Net
loss
|
(19,219)
|
|
(13,091)
|
|
(68,889)
|
|
(54,568)
|
Net loss attributable
to non-controlling interest
|
(555)
|
|
—
|
|
(555)
|
|
—
|
Net loss attributable
to Sangamo Therapeutics, Inc. stockholders
|
$ (18,664)
|
|
$ (13,091)
|
|
$ (68,334)
|
|
$ (54,568)
|
Basic and diluted net
loss per common share
|
$
(0.18)
|
|
$
(0.15)
|
|
$
(0.70)
|
|
$
(0.70)
|
Shares used in
computing basic and diluted net loss per common
share
|
102,057
|
|
84,820
|
|
96,941
|
|
78,084
|
|
|
|
|
|
|
|
|
SELECTED BALANCE
SHEET DATA
|
|
|
|
|
|
|
|
|
Year Ended
December 31,
|
|
|
|
|
|
2018
|
|
2017
|
|
|
|
|
|
(in
thousands)
|
|
|
|
|
Cash, cash
equivalents, marketable securities and interest
receivable
|
$ 400,508
|
|
$ 244,560
|
|
|
|
|
Total
assets
|
590,395
|
|
286,741
|
|
|
|
|
Total stockholders'
equity
|
366,518
|
|
187,900
|
|
|
|
|
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SOURCE Sangamo Therapeutics, Inc.