BRISBANE, Calif., May 8, 2019 /PRNewswire/ -- Sangamo
Therapeutics, Inc. (NASDAQ: SGMO), a genomic medicine company,
today reported first quarter 2019 financial results and recent
business highlights.
"With recent encouraging clinical data in hemophilia A gene
therapy and ex vivo gene-edited cell therapy for beta
thalassemia, we are moving closer to achieving our vision for
Sangamo as an integrated genomic medicine company," said
Sandy Macrae, CEO of Sangamo. "Our
capabilities in gene therapy, ex vivo gene-edited cell
therapy, in vivo genome editing and gene regulation enable
us to address genetic diseases with appropriate technologies. We
are investing in a diverse pipeline of products where we believe
this suite of proprietary technologies is clinically relevant,
where the underlying biology is well-characterized, and where there
is a defined high unmet medical need."
Recent Highlights
Clinical
- In partnership with Pfizer, announced phase 1/2 interim data
for SB-525, a gene therapy candidate for the treatment of adults
with hemophilia A, demonstrating dose-dependent increases in Factor
VIII (FVIII) activity in eight patients, with the two patients
treated with the 3e13 vg/kg dose reaching normal FVIII levels
- Initiated dose expansion of the 3e13 vg/kg dose cohort for the
SB-525 hemophilia A program, based on Safety Monitoring Committee
recommendations
- Announced early data from the first patient in the phase 1/2
clinical trial for ST-400, ex vivo gene-edited cell therapy
candidate for the treatment of beta thalassemia being developed in
partnership with Sanofi
Corporate
- Strengthened balance sheet with April
2019 public offering of common stock raising net proceeds of
approximately $136.2 million
- Signed option agreement with Brammer
Bio, a gene therapy contract development and manufacturing
organization, to secure access to large-scale, commercial-grade AAV
manufacturing
Research
- Publication of data demonstrating high-precision genome editing
with new zinc finger nuclease architectures in March 2019 issue of Nature
Communications
- Presented new preclinical data at 14th International
Conference on Alzheimer's & Parkinson's Diseases (ADPD)
demonstrating significant reduction in tau expression in non-human
primates with zinc finger protein transcription-factor (ZFP-TF)
gene regulation technology
- Presented data detailing zinc finger protein platform
enhancements, and several clinical and preclinical genomic medicine
programs at 2019 American Society of Gene & Cell Therapy
(ASGCT) Annual Meeting, held in Washington, D.C. between April 29th and May 2nd
- Presented preclinical data on the development of ZFP-TFs to
selectively downregulate expression of pathogenic C9ORF72 repeat
expansion-containing transcripts at the TargetALS meeting in
Boston on May 2nd
First Quarter 2019 Financial Results
For the first quarter ended March 31,
2019, Sangamo reported a consolidated net loss of
$42.2 million, or $0.41 per share, compared to a net loss of
$20.2 million, or $0.23 per share, for the same period in 2018. As
of March 31, 2019, the Company had
cash, cash equivalents, and investments of $351.6 million.
Revenues for the first quarter ended March 31, 2019 were $8.1
million, compared to $12.6
million for the same period in 2018. The decrease was
primarily due to a decline of $10.6
million in revenues related to our agreement with Pfizer due
to a change in estimate driven by an increase in project scope of
the hemophilia A collaboration and the corresponding decrease in
the measure of the proportional performance, and also a
$2.4 million decrease in revenues
related to our agreement with Sanofi (formerly Bioverativ). These
decreases were partially offset by an increase of $8.3 million in revenue related to our agreement
with Kite Pharma, which took effect in April
2018. First quarter 2019 revenues were primarily generated
from Sangamo's collaboration agreements with Kite, Sanofi and
Pfizer.
As anticipated, operating expenses increased in the first
quarter ended March 31, 2019,
reflecting the Company's growth through the acquisition of TxCell,
increased U.S. headcount in support of growth of the preclinical
pipeline and clinical development programs, and
manufacturing-related activities. Total operating expenses for the
first quarter ended March 31, 2019
were $52.0 million, compared to
$33.6 million for the same period in
2018. Research and development expenses were $34.9 million for the first quarter of 2019,
compared to $23.5 million for the
same period in 2018. 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 $17.1
million for the first quarter of 2019, compared to
$10.1 million for the same period in
2018.
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, and investments, including net proceeds
from the April 2019 common stock
offering, should provide funds for operations through year end
2021.
Conference Call
Sangamo will host a conference call today, May 8, 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 7577586. 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
May 8, 2019 to 11:59 p.m. ET on May 15,
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
7577586.
About Sangamo Therapeutics
Sangamo Therapeutics, Inc. is focused on translating
ground-breaking science into genomic medicines with the potential
to transform patients' lives using gene therapy, ex
vivo gene-edited cell therapy, in vivo
genome editing, and gene 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 regarding the Company's
vision to become an integrated genomic medicines company, the
Company's ability to develop and commercialize product candidates
to address genetic diseases with the Company's proprietary
technologies, the anticipated benefit from investing in
a diverse pipeline of products, and Sangamo's 2019 financial
guidance related to cash, cash equivalents, and investments,
anticipated operating expenses and cash runway. 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 Annual Report on Form 10-K for the year ended
December 31, 2018 as filed with the
Securities and Exchange Commission and Sangamo's Quarterly Report
on Form 10-Q for the quarter ended March 31,
2019 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
|
|
March
31,
|
|
2019
|
|
2018
|
|
|
|
|
Revenues
|
$
8,071
|
|
$
12,637
|
|
|
|
|
Operating
expenses:
|
|
|
|
Research and
development
|
34,850
|
|
23,547
|
General and
administrative
|
17,118
|
|
10,087
|
Total operating
expenses
|
51,968
|
|
33,634
|
Loss from
operations
|
(43,897)
|
|
(20,997)
|
Interest and other
income, net
|
1,694
|
|
810
|
Net loss
|
(42,203)
|
|
(20,187)
|
Net loss attributable
to non-controlling interest
|
(53)
|
|
—
|
Net loss attributable
to Sangamo Therapeutics, Inc. stockholders
|
$
(42,150)
|
|
$
(20,187)
|
Basic and diluted net
loss per common share attributable to Sangamo Therapeutics Inc.
stockholders
|
$
(0.41)
|
|
$
(0.23)
|
Shares used in
computing basic and diluted net loss per common share
attributable to Sangamo Therapeutics, Inc. stockholders
|
102,270
|
|
86,334
|
|
|
|
|
|
|
|
|
SELECTED BALANCE
SHEET DATA
|
|
|
|
|
March 31,
2019
|
|
December 31,
2018
|
|
|
|
|
Cash, cash
equivalents, and investments
|
$
351,590
|
|
$
400,508
|
Total
assets
|
542,729
|
|
590,395
|
Total stockholders'
equity
|
329,181
|
|
367,257
|
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SOURCE Sangamo Therapeutics, Inc.