Conference Call and Webcast Scheduled for 5:00
p.m. Eastern Time
Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine
company, today reported recent business highlights and first
quarter 2021 financial results.
“This quarter, we have continued our focus on advancing our lead
programs through clinical execution, regulatory interactions, and
collaborations with our partners and investigators. We are pleased
that enrollment has completed for Pfizer’s lead-in study for the
hemophilia A Phase 3 AFFINE trial. Additionally, the EMA granted
Orphan Designation and the FDA granted Fast Track Designation to
BIVV003, now known as SAR445136, our cell therapy product candidate
treating sickle cell disease partnered with Sanofi. Also, we
initiated the STEADFAST study for our product candidate treating
renal transplant rejection, which we believe is the first-in-human
CAR-Treg clinical study,” said Sandy Macrae, Chief Executive
Officer of Sangamo. “Further, our research engine continued to be
highly productive this quarter, advancing both our CAR-Treg
programs for autoimmune disorders and our transcriptional
regulation therapies for neurological diseases.”
Recent Business Highlights
- Completed enrollment of patients in Pfizer’s lead-in study to
the registrational Phase 3 AFFINE clinical trial of giroctocogene
fitelparvovec, a gene therapy product candidate for the treatment
of severe hemophilia A, developed in collaboration with
Pfizer.
- Received Fast Track Designation from the FDA for BIVV003, now
known as SAR445136, our cell therapy product candidate for the
treatment of sickle cell disease, developed in collaboration with
Sanofi. Also, the EMA granted Orphan Designation to SAR445136 based
on early clinical data from three treated patients.
- Initiated the Phase 1/2 STEADFAST clinical study evaluating
TX200, a wholly-owned autologous HLA-A2 CAR-Treg cell therapy
product candidate treating patients receiving a HLA-A2 mismatched
kidney from a living donor. The first patient is expected to be
enrolled in this study by the end of this year.
- Published preclinical data on tau- and alpha-synuclein-targeted
zinc finger transcriptional repressors in Science Advances and at
the 15th International Conference on Alzheimer’s & Parkinson’s
Diseases (ADPD), respectively. Also, announced upcoming preclinical
alpha-synuclein and C9ORF72 abstracts to be presented at the
upcoming 24th Annual Meeting of the American Society of Gene &
Cell Therapy (ASGCT) on May 11, 2021.
First Quarter 2021 Financial Results
Consolidated net loss for the first quarter ended March 31, 2021
was $45.9 million or $0.32 per share, compared to a net loss of
$42.9 million or $0.37 per share for the same period in 2020.
Revenues
Revenues for the first quarter ended March 31, 2021 were $26.3
million, compared to $13.1 million for the same period in 2020. The
increase of $13.2 million in revenues was primarily due to the
recognition of upfront license fees and research reimbursements
under our collaboration agreements with Biogen and Novartis, which
became effective in April and July 2020, respectively. These
increases were partially offset by a decrease in revenue related to
our hemophilia A collaboration with Pfizer, as a result of
completion of our reimbursable activities in the fourth quarter of
2020.
GAAP and Non-GAAP operating expenses
Three Months EndedMarch 31, (In millions)
2021
2020
Research and development
$
56.5
$
41.5
General and administrative
16.1
16.1
Total operating expenses
72.6
57.6
Stock-based compensation expense
(7.5
)
(5.6
)
Non-GAAP operating expenses
$
65.1
$
52.0
Total operating expenses on a GAAP basis for the first quarter
ended March 31, 2021 were $72.6 million compared to $57.6 million
for the same period in 2020. Non-GAAP operating expenses, which
exclude stock-based compensation expense, for the first quarter
ended March 31, 2021 were $65.1 million compared to $52.0 million
for the same period in 2020.
The increase in total operating expenses on a GAAP basis was
primarily driven by our higher clinical and manufacturing supply
expenses to support the advancement of our clinical trials and our
new collaborations along with our increased headcount.
Cash, cash equivalents and marketable securities
Cash, cash equivalents and marketable securities as of March 31,
2021 were $629.5 million compared to $692.0 million as of December
31, 2020.
Guidance for 2021 Reiterated (initial guidance provided on
February 24, 2021)
On a GAAP basis, we expect total operating expenses, including
non-cash stock-based compensation expenses, to be in the range of
approximately $285 million to $305 million.
On a non-GAAP basis, we expect total operating expenses,
excluding estimated non-cash stock-based compensation expense of
approximately $30 million, to be in the range of approximately $255
million to $275 million.
Conference Call
Sangamo will host a conference call today, May 4, 2021, 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 5714729. 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 5714729.
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, cell therapy, and genome
engineering. For more information about Sangamo, visit
www.sangamo.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding
our current expectations. These forward-looking statements include,
without limitation, statements relating to advancing our clinical
programs, the therapeutic potential of our product candidates,
anticipated plans and timeline for enrolling and conducting
clinical trials, our 2021 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 our collaborators, including the
initiation and operation of clinical trials; the research and
development process, including the enrollment, operation and
results of clinical trials; and our ability to achieve expected
future financial performance.
There can be no assurance that we and our collaborators will be
able to develop commercially viable products. Actual results may
differ materially from those projected in these forward-looking
statements due to the risks and uncertainties described above and
other risks and uncertainties that exist in the operations and
business environments of Sangamo and our collaborators. These risks
and uncertainties are described more fully in our Securities and
Exchange Commission filings and reports, including in our Annual
Report on Form 10-K for the year ended December 31, 2020.
Forward-looking statements contained in this announcement are made
as of this date, and we undertake no duty to update such
information except as required under applicable law.
Non-GAAP Financial Measure
To supplement our financial results and guidance presented in
accordance with GAAP, we present non-GAAP total operating expenses,
which exclude stock-based compensation expense from GAAP total
operating expenses. We believe that this non-GAAP financial
measure, when considered together with our financial information
prepared in accordance with GAAP, can enhance investors’ and
analysts’ ability to meaningfully compare our results from period
to period and to our forward-looking guidance, and to identify
operating trends in our business. We have 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. We
encourage investors to carefully consider our results under GAAP,
as well as our supplemental non-GAAP financial information, to more
fully understand our business.
SELECTED CONSOLIDATED FINANCIAL DATA (unaudited; in
thousands, except per share data)
Statement of
Operations Data: Three months ended March 31,
2021
2020
Revenues
$
26,280
$
13,076
Operating expenses: Research and development
56,434
41,479
General and administrative
16,148
16,119
Total operating expenses
72,582
57,598
Loss from operations
(46,302
)
(44,522
)
Interest and other income, net
625
1,548
Loss before taxes
(45,677
)
(42,974
)
Income tax expense
262
-
Net loss
(45,939
)
(42,974
)
Net loss attributable to non-controlling interest
(6
)
(61
)
Net loss to Sangamo Therapeutics, Inc. stockholders
$
(45,933
)
$
(42,913
)
Basic and diluted net loss per share attributable to Sangamo
Therapeutics, Inc. stockholders
$
(0.32
)
$
(0.37
)
Shares used in computing basic and diluted net loss per share
attributable to Sangamo Therapeutics, Inc. stockholders
143,112
116,060
Selected Balance Sheet Data:
March 31, 2021
December 31, 2020
Cash, cash equivalents and marketable securities
$
629,515
$
691,953
Total assets
$
877,095
$
938,550
Total stockholders' equity
$
469,417
$
497,366
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version on businesswire.com: https://www.businesswire.com/news/home/20210504006117/en/
Investor Relations & Media
Inquiries Aron Feingold 628.252.7494
afeingold@sangamo.com
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