RICHMOND, Calif., Nov. 8, 2018 /PRNewswire/ -- Sangamo
Therapeutics, Inc. (NASDAQ: SGMO) today reported third quarter 2018
financial results and recent business highlights.
"I'm pleased with our continued execution toward our vision to
transform Sangamo into the premier genomic medicines company," said
Sandy Macrae, CEO of Sangamo. "We've
made strong progress across our clinical development programs and
look forward to potential data readouts and updates from multiple
clinical trials in coming months. We expect to complete the final
steps of the acquisition of TxCell by year end, establishing our
leadership in the promising field of CAR-Tregs for immunological
and autoimmune diseases. Finally, we are continuing to strengthen
the leadership team with the addition of Stephane Boissel as EVP of Corporate
Strategy."
Recent Highlights
Clinical
- In September, Sangamo presented 16-week clinical results from
the first two cohorts of the Phase 1/2 CHAMPIONS Study evaluating
SB-913 for Mucopolysaccharidosis Type II (MPS II), including
dose-dependent reductions in glycosaminoglycans (GAGs) in the
second cohort (1e13 vector genomes per kilogram of body weight, or
vg/kg). At 16 weeks, in all subjects, administration of SB-913 was
generally well-tolerated, with no treatment-related serious adverse
events reported. Most adverse events reported were mild (Grade 1)
and resolved without treatment.
- In October, the independent Safety Monitoring Committee (SMC)
of the CHAMPIONS Study evaluating SB-913 in patients with MPS II
reviewed accumulated safety and efficacy data from all three
cohorts and made the following three recommendations:
-
- 1) proceed to the cohort expansion phase of the clinical trial
with the dose used at the third dose cohort (5e13
vg/kg);
- 2) initiate screening and enrollment of adolescent subjects (12
to 17 years of age); and
- 3) initiate the withdrawal of enzyme replacement therapy (ERT)
when appropriate.
- In October, the independent SMC of the Phase 1/2 Alta Study
evaluating SB-525 for hemophilia A reviewed accumulated safety and
efficacy data from six patients enrolled in three dose cohorts. As
of that review, SB-525 exhibited dose-dependent efficacy on serum
factor levels and was generally well-tolerated with no
treatment-related serious adverse events and no use of tapering
courses of oral steroids. The SMC recommended that the study
continue with escalation to an additional dose. Sangamo plans to
present safety and efficacy data from the Alta Study after dose
escalation is complete and the clinical trial has progressed to the
cohort expansion phase. SB-525 is being developed as part of a
global collaboration between Sangamo and Pfizer
Inc. for the development and commercialization of potential
gene therapy programs for hemophilia A.
- A second patient has been treated in Phase 1/2 EMPOWERS Study
evaluating SB-318 for MPS I. Per the recommendation of the SB-318
SMC, which in October reviewed accumulated safety and efficacy data
from both the EMPOWERS Study and the CHAMPIONS Study evaluating
SB-913 for MPS II, this patient received the 5e13 vg/kg dose, the
highest dose.
"The independent SMC's recommendations for the CHAMPIONS Study
highlight the important progress we've made in this program," said
Ed Conner, Chief Medical Officer of
Sangamo. "We believe that SB-913 may have the potential to improve
upon the current standard of care for patients with MPS II, and we
look forward to presenting updated results from this clinical trial
early next year."
Dr. Conner continued: "Regarding SB-525, we are pleased with the
SMC's recommendation for escalation to an additional dose, which is
enabled by the safety profile, the lack of immunogenicity, and the
dose-dependent response observed to date across the first three
dose cohorts. Our goal is to advance into the pivotal phase of
development with the dose that holds the highest potential to meet
the needs of patients with hemophilia A. We do not believe that
others have yet presented data that would support an optimal
product profile for hemophilia A gene therapy."
Corporate
- Sangamo completed the acquisition of a majority of TxCell S.A.
(TxCell) ordinary shares in October and has since launched a
general tender offer on the remaining ordinary shares of TxCell
listed on Euronext in Paris.
TxCell is a leader in the emerging field of regulatory T cell
(Treg) development for immunological diseases, one of Sangamo's
stated therapeutic areas of focus for its proprietary product
candidate pipeline. Sangamo intends to evaluate the potential of
CAR-Treg (Tregs genetically modified with a chimeric antigen
receptor, or CAR) therapies to prevent graft rejection in solid
organ transplant and for the treatment of autoimmune diseases.
- Stéphane Boissel, former CEO of TxCell, joined Sangamo as
Executive Vice President of Corporate Strategy.
Third Quarter 2018 Financial Results
For the third
quarter ended September 30, 2018,
Sangamo reported a consolidated net loss of $12.8 million, or $0.13 per share, compared to a net loss of
$12.4 million, or $0.15 per share, for the same period in 2017. As
of September 30, 2018, the Company
had cash, cash equivalents, marketable securities and interest
receivable of $459.3 million.
Revenues for the third quarter ended September 30, 2018 were $23.6 million, compared to $11.8 million for the same period in
2017. The increase came primarily from $9.0 million in revenues related to our
collaboration with Kite, a Gilead Company, which included
reimbursement of $2.7 million in
research services. Third quarter 2018 revenues were primarily
generated from Sangamo's collaboration agreements with Kite, Pfizer
and Bioverativ, a Sanofi company.
Total operating expenses for the third quarter ended
September 30, 2018 were $39.8 million, compared to $24.8 million for the same period in 2017.
Research and development expenses were $28.8
million for the third quarter of 2018, compared to
$18.4 million for the same period in
2017. The increase was primarily due to manufacturing and clinical
trial expenses related to the progress of our clinical development
programs. General and administrative expenses were $11.0 million for the third quarter of 2018,
compared to $6.4 million for the same
period in 2017. This increase was primarily due to general support
of growth in our pipeline and clinical programs as well as one-time
transaction cost associated with the TxCell acquisition.
Financial Guidance for 2018
- Cash and Investments: Sangamo expects to report a
balance of cash, cash equivalents, marketable securities and
interest receivable of at least $380
million at December 31, 2018.
This anticipated cash balance is inclusive of research funding from
existing collaborators and recent financings and is expected to
last approximately two years.
- Operating Expense: Sangamo expects operating expense of
$160 million to $165 million for the year ending December 31, 2018.
Conference Call
Sangamo will host a conference call
today, November 8, 2018, 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 9494369. 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 8, 2018 to 11:59 p.m. ET on November
15, 2018. 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
9494369.
About Sangamo
Sangamo Therapeutics is focused on
translating ground-breaking science into genomic therapies that
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, the potential for data readouts and
updates from multiple clinical trials in coming months, completion
of the acquisition of TxCell by year end, Sangamo's plan to present
updated safety and efficacy data from the Alta Study after dose
escalation is complete and the clinical trial has progressed to the
cohort expansion phase, Sangamo's plan to present updated results
from the CHAMPIONS Study early next year; Sangamo's year-end
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 of lead programs, the lengthy and
uncertain regulatory approval process, uncertainties related to the
initiation and completion of clinical trials, including the Alta
study and CHAMPIONS study, whether the final results from the Alta
study and CHAMPIONS study will validate and support the safety and
efficacy of SB-525 and SB-913, respectively, 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 June 30, 2018 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
|
(unaudited; in
thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Statement of
Operations Data:
|
|
Three months
ended
|
|
For the Nine
Months Ended
|
|
September
30,
|
|
September
30,
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
Collaboration
agreements
|
$
23,538
|
|
$
11,759
|
|
$
57,378
|
|
$
23,042
|
Research
grants
|
24
|
|
53
|
|
237
|
|
448
|
Total revenues
|
23,562
|
|
11,812
|
|
57,615
|
|
23,490
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
28,810
|
|
18,425
|
|
81,612
|
|
46,351
|
General and
administrative
|
10,993
|
|
6,422
|
|
32,381
|
|
19,734
|
Total operating
expenses
|
39,803
|
|
24,847
|
|
113,993
|
|
66,085
|
Loss from
operations
|
(16,241)
|
|
(13,035)
|
|
(56,378)
|
|
(42,595)
|
Interest and other
income, net
|
3,398
|
|
681
|
|
6,708
|
|
1,118
|
Net loss
|
$
(12,843)
|
|
$
(12,354)
|
|
$ (49,670)
|
|
$ (41,477)
|
Basic and diluted net
loss per common share
|
$
(0.13)
|
|
$
(0.15)
|
|
$
(0.52)
|
|
$
(0.55)
|
Shares used in
computing basic and diluted net loss per common
share
|
101,725
|
|
83,750
|
|
95,165
|
|
75,814
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SELECTED BALANCE
SHEET DATA
|
|
|
|
|
|
|
|
|
September 30,
2018
|
|
December 31,
2017
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents, marketable securities and interest
receivable
|
$
459,253
|
|
$
244,560
|
|
|
|
|
Total
assets
|
606,604
|
|
286,741
|
|
|
|
|
Total stockholders'
equity
|
379,906
|
|
187,900
|
|
|
|
|
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SOURCE Sangamo Therapeutics, Inc.