Conference Call and Webcast Scheduled for 5:00
p.m. Eastern Time
Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine
company, today reported third quarter 2020 financial results and
recent business highlights.
“We are pleased with the clinical execution momentum across our
portfolio, including the first patient dosed in the registrational
AFFINE study of our investigational hemophilia A gene therapy
partnered with Pfizer, as well as dosing of the first two patients
in the Phase 1/2 STAAR study evaluating our Fabry disease gene
therapy,” said Sandy Macrae, CEO of Sangamo. “We also continue to
advance our research projects, exemplified by the completion of our
research activities in our ALS program partnered with Pfizer.”
Business Updates
- Earned a $30 million milestone from Pfizer for the dosing of
the first patient in the registrational Phase 3 AFFINE study of
investigational hemophilia A gene therapy giroctocogene
fitelparvovec (SB-525).
- Pfizer provided updated data from the Phase 1/2 Alta study of
giroctocogene fitelparvovec demonstrating tolerability, clinically
meaningful factor levels with no bleeds and no prophylactic factor
use through up to 85 weeks in the longest patient treated in the
highest dose cohort.
- Completed dosing of the first two patients in our Phase 1/2
STAAR study evaluating our investigational ST-920 gene therapy in
Fabry disease.
- Received additional regulatory approvals supporting the
first-in-human Phase 1/2 STEADFAST study evaluating our CAR-Treg
product candidate TX200 in kidney transplantation.
- Completed our research activities in our collaboration with
Pfizer to develop gene regulation therapies using zinc finger
protein transcription factors for the treatment of C9ORF72-related
Amyotrophic Lateral Sclerosis (ALS). Earned a $5 million milestone
related to the program.
- Appointed Dr. Kenneth Hillan MB ChB, to our Board of
Directors.
Third Quarter 2020 Financial Results
Cash, cash equivalents and marketable securities were $694.6
million as of September 30, 2020, compared to $384.3 million as of
December 31, 2019. The balance at the end of the third quarter
includes the previously announced $75.0 million upfront license fee
from Novartis. We expect to receive the $35 million in milestone
payments from Pfizer in the fourth quarter.
Consolidated net loss attributable to Sangamo for the third
quarter ended September 30, 2020 was $1.6 million, or $0.01 per
share, compared to a net loss of $27.3 million, or $0.24 per share,
for the same period in 2019. Revenues for the third quarter ended
September 30, 2020 were $57.8 million, compared to $22.0 million
for the same period in 2019.
Three Months Ended September
Nine Months Ended September
(In millions)
2020
2019
2020
2019
Research and development
$
45.3
$
36.3
$
128.3
$
107.6
General and administrative
16.2
14.9
50.2
46.6
Total operating expenses
61.5
51.2
178.5
154.2
Stock-based compensation expense
(6.7
)
(4.7
)
(19.1
)
(14.1
)
Non-GAAP operating expenses
$
54.8
$
46.5
$
159.4
$
140.1
Total operating expenses were $61.5 million for the third
quarter ended September 30, 2020, compared to $51.2 million for the
same period in 2019. Non-GAAP operating expenses, which exclude
stock-based compensation expense, were $54.8 million for the third
quarter ended September 30, 2020, compared to $46.5 million for the
same period in 2019. The increase in operating expenses reflects
our headcount growth and facilities expansion to support the
advancement of our therapeutic pipeline and manufacturing
capabilities. These increases were partially offset by a decrease
in clinical and manufacturing supply expenses.
Revised Financial Guidance for 2020
We are revising our full year operating expense guidance
initially provided on February 28, 2020 and revised on August 5,
2020 as follows:
(In millions)
Initially Provided February 28,
2020; Reiterated May 11, 2020
Revised on August 5, 2020
Updated on November 4, 2020
Estimated GAAP Operating Expenses
$270 to $285
$235 to $250
$235 to $245
Estimated Non-GAAP Operating Expenses*
$245 to $260
$210 to $225
$210 to $220
*(excludes estimated stock-based
compensation of $25 million)
Conference Call
Sangamo will host a conference call today, November 4, 2020, at
5:00 p.m. Eastern Time, which will be open to the public. The call
will also be webcast with live Q&A 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 2575067. Participants may
access the live webcast via a link on the Sangamo Therapeutics
website in the Investors and Media section under Events and
Presentations. A conference call replay will be available for one
week following the conference call. 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 2575067.
About Sangamo Therapeutics
Sangamo Therapeutics is committed to translating ground-breaking
science into genomic medicines with the potential to transform
patients’ lives using gene therapy, ex vivo gene-edited cell
therapy, and in vivo genome editing and genome regulation. 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 relating to the potential
clinical benefits and long-term durability of SB-525 therapy,
anticipated plans and timelines of Sangamo and its collaborators
for conducting clinical trials, the potential to receive milestone
payments under our collaborations with Pfizer and the timing of
such payments, Sangamo’s financial resources and expectations,
Sangamo’s 2020 financial guidance related to GAAP and non-GAAP
total operating expenses and stock-based compensation and other
statements that are not historical fact. These statements are not
guarantees of future performance and are subject to certain risks
and uncertainties that are difficult to predict. Factors that could
cause actual results to differ include, but are not limited to,
risks and uncertainties related to the effects of the evolving
COVID-19 pandemic and the impacts of the pandemic on the global
business environment, healthcare systems and business and
operations of Sangamo and its collaborators, including the
initiation and operation of clinical trials; the research and
development process; the uncertain timing and unpredictable results
of clinical trials, including whether final clinical trial data
will validate the safety and efficacy of product candidates; the
regulatory approval process for clinical trials and product
candidates; the manufacturing of products and product candidates;
the commercialization of approved products; the potential for
technological developments that obviate technologies used by
Sangamo and its collaborators; the potential for Sangamo or its
collaborators to breach or terminate collaboration agreements; the
potential for Sangamo to fail to realize its expected benefits of
its collaborations; and Sangamo’s ability to achieve expected
future financial performance.
There can be no assurance that Sangamo and its collaborators
will be able to develop commercially viable products. Actual
results may differ from those projected in forward-looking
statements due to risks and uncertainties that exist in the
operations and business environments of Sangamo and its
collaborators. These risks and uncertainties are described more
fully in Sangamo’s Securities and Exchange Commission filings and
reports, including in Sangamo’s Quarterly Report on Form 10-Q for
the quarter ended September 30, 2020. 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.
Non-GAAP Financial Measures
To supplement Sangamo’s financial results and guidance presented
in accordance with GAAP, Sangamo presents non-GAAP total operating
expenses, which exclude stock-based compensation expense from GAAP
total operating expenses. Sangamo believes that this non-GAAP
financial measure, when considered together with its financial
information prepared in accordance with GAAP, can enhance
investors’ and analysts’ ability to meaningfully compare Sangamo’s
results from period to period and to its forward-looking guidance,
and to identify operating trends in Sangamo’s business. Sangamo has
excluded stock-based compensation expense because it is a non-cash
expense that may vary significantly from period to period as a
result of changes not directly or immediately related to the
operational performance for the periods presented. This non-GAAP
financial measure is in addition to, not a substitute for, or
superior to, measures of financial performance prepared in
accordance with GAAP. Sangamo encourages investors to carefully
consider its results under GAAP, as well as its supplemental
non-GAAP financial information, to more fully understand Sangamo’s
business.
SELECTED CONSOLIDATED FINANCIAL DATA (unaudited; in
thousands, except per share data)
Statement of Operations
Data:
Three months ended
Nine Months Ended
September 30,
September 30,
2020
2019
2020
2019
Revenues
$
57,763
$
21,958
$
92,392
$
47,577
Operating expenses: Research and development
45,287
36,288
128,289
107,593
General and administrative
16,177
14,918
50,223
46,633
Total operating expenses
61,464
51,206
178,512
154,226
Loss from operations
(3,701
)
(29,248
)
(86,120
)
(106,649
)
Interest and other income, net
2,430
1,887
5,910
6,729
Loss before taxes
(1,271
)
(27,361
)
(80,210
)
(99,920
)
Income tax expense
(237
)
—
(237
)
—
Net loss
(1,508
)
(27,361
)
(80,447
)
(99,920
)
Net income (loss) attributable to non-controlling interests
42
(54
)
(55
)
(179
)
Net loss attributable to Sangamo Therapeutics, Inc. stockholders
$
(1,550
)
$
(27,307
)
$
(80,392
)
$
(99,741
)
Basic and diluted net loss per common share attributable to Sangamo
Therapeutics Inc. stockholders
$
(0.01
)
$
(0.24
)
$
(0.61
)
$
(0.90
)
Shares used in computing basic and diluted net loss per share
attributable to Sangamo Therapeutics, Inc. stockholders
141,100
115,710
132,079
110,837
Balance Sheet Data: September 30,
2020 December 31, 2019
Cash, cash equivalents and marketable securities
$
694,588
$
384,306
Total assets
963,710
637,516
Total stockholders' equity
520,881
432,739
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version on businesswire.com: https://www.businesswire.com/news/home/20201104005034/en/
Investor Relations & Media
Inquiries Aron Feingold 628.252.7494
afeingold@sangamo.com
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