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 2019 financial results and
recent business highlights.
“We continue to prioritize and progress our clinical development
programs, as demonstrated by the accepted ASH poster presentations
for our two most advanced programs, SB-525 hemophilia A gene
therapy and ST-400 beta thalassemia cell therapy. Patients are
currently being screened for enrollment into the clinical study
evaluating ST-920, our wholly owned Fabry disease gene therapy, and
we expect to enroll a first patient by the end of the year. We have
also recently submitted a CTA for the clinical trial of our
CAR-Treg, TX200, in mismatched renal transplantation,” said Sandy
Macrae, CEO of Sangamo. “As it is important that we continue to
articulate our drug development, research, and partnership
strategies, we will host a Sangamo R&D day in New York on
December 17, 2019. At this meeting, we will provide updates across
our various genomic medicine programs, offer our perspective on the
clinical data at ASH, share improvements across our technology
platforms, and provide an overview of the manufacturing strategy to
support our clinical and commercial supply.”
Recent Highlights
Clinical
- Earlier today, announced the upcoming poster presentation of
three abstracts at the 61st American Society of Hematology (ASH)
annual meeting in Florida:
- Updated follow-up of the Phase 1/2 Alta Study assessing SB-525
gene therapy in adult patients with severe hemophilia A in
partnership with Pfizer.
- Preliminary information from the Phase 1/2 THALES Study
assessing ST-400 ex vivo gene-edited cell therapy in patients with
transfusion-dependent beta thalassemia in partnership with
Sanofi.
- In vitro results of zinc finger nuclease-mediated disruption of
BCL11A erythroid enhancer in erythroid cells derived from patients
with sickle cell disease.
- Significant progress made on advancing the transfer of SB-525
development to our partner Pfizer, who will run the Phase 3
registrational clinical trial, including completing manufacturing
technology transfer and initiating transfer of the investigational
new drug application (IND). Pfizer announced it has enrolled its
first patient in the 6-month lead-in study, which is expected to
serve as a baseline control for the patients who are enrolled into
the Phase 3 study.
- Activated a fourth US clinical site for the STAAR study
evaluating ST-920, an investigational gene therapy candidate for
Fabry disease. Sangamo is currently screening patients in the US
for enrollment into the clinical study and expects to enroll the
first patient this year.
- Received approval of the clinical trial authorization
application (CTA) for ST-920, allowing expansion of the study into
the UK. Additionally, the FDA granted Orphan Drug Designation to
ST-920 for the treatment of Fabry disease.
- Following the dosing of a third patient in the THALES Study,
Sangamo achieved a $6.0M milestone with Sanofi and received $2.1M
from the California Institute for Regenerative Medicine (CIRM).
Enrollment of all 6 patients in the Phase 1/2 study is expected to
be completed in 2019.
- Sanofi is currently recruiting patients into the Phase 1/2
PRECIZN-1 trial evaluating BIVV003 gene-edited cell therapy for the
treatment of sickle cell disease.
- Filed the CTA for TX200, a CAR-Treg product candidate, in
HLA-A2 mismatched kidney transplantation.
- Kite, a Gilead Company, is planning to initiate a clinical
study of KITE-037, an allogeneic anti-CD19 CAR-T cell product, in
2020.
Corporate
- Announced Sangamo R&D day to be held in New York City on
December 17, 2019.
- Hired Sung Lee as Executive Vice President and Chief Financial
Officer.
- Hired Bettina Cockroft as Senior Vice President and Chief
Medical Officer.
- Promoted R. Andrew Ramelmeier to Executive Vice President,
Technical Operations.
Third Quarter 2019 Financial Results
For the third quarter ended September 30, 2019, Sangamo reported
a consolidated net loss of $27.3 million, or $0.24 per share,
compared to a net loss of $12.8 million, or $0.13 per share, for
the same period in 2018. As of September 30, 2019, the Company had
cash, cash equivalents, and investments of $408.3 million.
Revenues for the third quarter ended September 30, 2019 were
$22.0 million, compared to $23.6 million for the same period in
2018. The decrease of $1.6 million was primarily driven by the
decrease of $7.0 million in revenues related to Pfizer and $1.4
million related to royalty revenues offset by increases of $6.5
million in revenues related to Sanofi as the Company achieved a
$6.0 million milestone upon dosing the third subject in the Phase
1/2 THALES study in August 2019.
As anticipated, operating expenses increased in the third
quarter, reflecting the Company’s growth through increased U.S.
headcount in support of growth of the clinical development programs
and preclinical pipeline, and manufacturing-readiness activities.
Total operating expenses for the third quarter ended September 30,
2019 were $51.2 million, compared to $39.8 million for the same
period in 2018. Research and development expenses were $36.3
million for the third quarter of 2019, compared to $28.8 million
for the same period in 2018. The increase is primarily due to
higher compensation costs from headcount growth, higher facility
expenses related to our new Brisbane facility, and higher
manufacturing expenses related to our clinical activities. General
and administrative expenses were $14.9 million for the third
quarter of 2019, compared to $11.0 million for the same period in
2018. The increase was primarily due to increased compensation
costs due to headcount growth and increased facility expenses.
Construction of our in-house manufacturing capability in Brisbane
is proceeding on schedule, and we still expect to commence Good
Manufacturing Practice (GMP) qualification procedures early next
year.
Financial Guidance for 2019
- Operating Expense: Sangamo expects operating expense of
$210.0 to $220.0 million for the year ending December 31,
2019.
- Cash and Investments: Sangamo projects that current
cash, cash equivalents, and investments should provide funds for
operations through year end 2021.
Conference Call
Sangamo will host a conference call today, November 6, 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 7276749. 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
7276749.
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
ability to develop and commercialize product candidates to address
genetic diseases with the Company's proprietary technologies; the
timing of commencement or next stages of such programs and the
anticipated benefits therefrom; 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 outcomes of clinical trials, the uncertain
regulatory approval process, uncertainties related to the execution
of clinical trials, uncertainties that research outcomes will
support clinical programs, Sangamo's reliance on partners and other
third-parties to meet their clinical and manufacturing obligations,
and the ability to maintain strategic partnerships. 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 on March 1, 2019 and Sangamo's Quarterly Report on Form
10-Q for the quarter ended September 30, 2019 that it filed on or
about November 6, 2019. 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,
2019
2018
2019
2018
Revenues
$
21,958
$
23,562
$
47,577
$
57,615
Operating expenses: Research and development
36,288
28,810
107,593
81,612
General and administrative
14,918
10,993
46,633
32,381
Total operating expenses
51,206
39,803
154,226
113,993
Loss from operations
(29,248
)
(16,241
)
(106,649
)
(56,378
)
Interest and other income, net
1,887
3,398
6,729
6,708
Net loss
(27,361
)
(12,843
)
(99,920
)
(49,670
)
Net loss attributable to non-controlling interests
(54
)
-
(179
)
-
Net loss attributable to Sangamo Therapeutics, Inc. stockholders
$
(27,307
)
$
(12,843
)
$
(99,741
)
$
(49,670
)
Basic and diluted net loss per common share attributable to Sangamo
Therapeutics Inc. stockholders
$
(0.24
)
$
(0.13
)
$
(0.90
)
$
(0.52
)
Shares used in computing basic and diluted net loss per common
share attributable to Sangamo Therapeutics, Inc. stockholders
115,710
101,725
110,837
95,165
Balance Sheet Data: September 30, 2019 December
31, 2018 Cash, cash equivalents, marketable
securities and interest receivable
$
408,321
$
400,508
Total assets
640,222
590,395
Total stockholders' equity
419,328
367,257
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191106005882/en/
Investor Relations – Global McDavid
Stilwell 510-970-6000, x219 mstilwell@sangamo.com
Media Inquiries – Global Aron
Feingold 510-970-6000, x421 afeingold@sangamo.com
Investor Relations and Media Inquiries –
European Union & United Kingdom Caroline Courme 33 4 97
21 27 27 ccourme@sangamo.com
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