Conference Call and Webcast Scheduled for 5:00
p.m. Eastern Time
Sangamo Therapeutics, Inc. (NASDAQ: SGMO), a genomic medicine
company, today reported second quarter 2019 financial results and
recent business highlights.
“We continue to progress our strategy to develop our diversified
portfolio of genomic medicine product candidates using our
expertise in gene therapy, cell therapy, genome editing and gene
regulation,” said Sandy Macrae, CEO of Sangamo. “Last month, we
reported updated results for SB-525, our investigational gene
therapy for hemophilia A. We are pleased with the emerging clinical
profile and competitive positioning of SB-525 and are preparing for
a Phase 3 registrational study with our partner Pfizer. The THALES
study evaluating ST-400, a gene-edited cell therapy for beta
thalassemia being developed with Sanofi, is progressing well and
recently enrolled a fourth patient. In the upcoming months, two of
our wholly owned programs, ST-920, an investigational gene therapy
for Fabry disease, and TX-200, our first CAR-Treg product
candidate, are also expected to advance into the clinic.”
“We have observed significant increases in efficacy above a
defined vector dose threshold with AAV6, the vector we use in our
hemophilia gene therapy and our in vivo genome editing clinical
programs,” Dr. Macrae continued. “These recent insights into the
kinetics of AAV6 suggest rational methods for improving the
delivery of zinc finger nucleases, which we believe may
substantially enhance the efficacy of in vivo genome editing,
especially when added to the significantly increased potency that
we expect to obtain with our updated gene editing reagents. We
believe we can integrate these improvements rapidly and plan to
introduce them as the next step forward for our in vivo genome
editing clinical development programs. Based on current
assumptions, including the timelines for manufacturing, we now
expect that our next in vivo genome editing clinical trial will
commence by year end 2020.”
Recent Highlights
Clinical
- In partnership with Pfizer, presented updated Phase 1/2 data
for SB-525, an investigational gene therapy for the treatment of
adults with hemophilia A. The data showed that SB-525 was generally
well-tolerated and demonstrated a dose-dependent increase in Factor
VIII (FVIII) activity levels. The first two patients treated at the
3e13 vg/kg dose rapidly achieved normal levels of FVIII activity,
with no reported bleeding events or exogenous FVIII usage. The
response was durable for at least 24 weeks, the extent of follow-up
at the time of the data cut-off. The two patients most recently
treated at the 3e13 vg/kg dose level are demonstrating FVIII
activity kinetics that appear consistent with the first two
patients treated in this dose cohort at similar early time
points.
- In July, dosed the fifth patient in the 3e13 vg/kg cohort
(Patient 11 in the study), completing enrollment of the Phase 1/2
study evaluating SB-525
- United States Food and Drug Administration granted regenerative
medicine advanced therapy (RMAT) designation for SB-525 gene
therapy to treat severe hemophilia A
- Preparations have begun to advance SB-525 into a Phase 3
registrational clinical trial, including engagement with regulators
and initiating the transfer of the SB-525 manufacturing process to
Pfizer
- Enrolled a fourth patient into the Phase 1/2 clinical trial for
ST-400, an ex vivo gene-edited cell therapy candidate for the
treatment of beta thalassemia, which is being developed in
partnership with Sanofi. Sanofi is conducting a Phase 1/2 clinical
trial evaluating BIVV003, a separate but related gene-edited cell
therapy candidate for sickle cell disease.
- Activated the first clinical site for the STAAR study
evaluating ST-920, an investigational gene therapy candidate for
Fabry disease. Sangamo expects to enroll the first patient by year
end 2019.
- Remain on track to file CTA in 2019 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, in 2020.
Research
- Published a manuscript detailing the activity of disease
allele-selective zinc finger proteins in preclinical models of
Huntington’s disease in the July 2019 issue of Nature Medicine
- Published a manuscript detailing two new approaches for
optimizing the specificity of genome editing with zinc finger
nucleases in the August 2019 issue of Nature Biotechnology
Corporate
- Hired Gary Loeb as Executive Vice President and General
Counsel
Second Quarter 2019 Financial Results
For the second quarter ended June 30, 2019, Sangamo reported a
consolidated net loss of $30.3 million, or $0.26 per share,
compared to a net loss of $16.6 million, or $0.17 per share, for
the same period in 2018. As of June 30, 2019, the Company had cash,
cash equivalents, and investments of $450.3 million.
Revenues for the second quarter ended June 30, 2019 were $17.5
million, compared to $21.4 million for the same period in 2018. The
decrease was primarily due to a decline of $3.7 million in revenues
related to the agreement with Pfizer due to a change in estimate
resulting from the expansion of the project scope of the hemophilia
A collaboration.
As anticipated, operating expenses increased in the second
quarter ended June 30, 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 second quarter ended June 30, 2019 were
$51.1 million, compared to $40.6 million for the same period in
2018. Research and development expenses were $36.5 million for the
second quarter of 2019, compared to $29.3 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 $14.6 million for the second quarter of 2019, compared to
$11.3 million for the same period in 2018. The increase was
primarily due to increased compensation costs related to headcount
growth and increased facility expenses, primarily related to our
new Brisbane facility.
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 should provide funds for
operations through year end 2021.
Conference Call
Sangamo will host a conference call today, August 7, 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 9582057. 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
9582057.
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
anticipated benefit from investing in a diverse pipeline of
products; Sangamo’s ability to enhance efficacy of in vivo gene
editing, increase potency with Sangamo’s updated gene editing
reagents and integrate such improvements into its gene editing
clinical development programs, as well as the timing of
commencement 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. 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 June 30, 2019 that it filed August 7, 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 CONDENSED CONSOLIDATED FINANCIAL DATA (unaudited;
in thousands, except per share data)
Statement of
Operations Data:
Three months ended
Six Months Ended
June 30,
June 30,
2019
2018
2019
2018
Revenues
$
17,548
$
21,416
$
25,619
$
34,053
Operating expenses: Research and development
36,455
29,255
71,305
52,802
General and administrative
14,597
11,301
31,715
21,388
Total operating expenses
51,052
40,556
103,020
74,190
Loss from operations
(33,504
)
(19,140
)
(77,401
)
(40,137
)
Interest and other income, net
3,148
2,500
4,842
3,310
Net loss
(30,356
)
(16,640
)
(72,559
)
(36,827
)
Net loss attributable to non-controlling interest
(72
)
-
(125
)
-
Net loss attributable to Sangamo Therapeutics, Inc. stockholders
$
(30,284
)
$
(16,640
)
$
(72,434
)
$
(36,827
)
Basic and diluted net loss per common share attributable to Sangamo
Therapeutics Inc. stockholders
$
(0.26
)
$
(0.17
)
$
(0.67
)
$
(0.40
)
Shares used in computing basic and diluted net loss per common
share attributable to Sangamo Therapeutics, Inc. stockholders
114,382
97,267
108,360
91,831
BALANCE SHEET DATA
June 30,
2019
December
31, 2018
Cash, cash equivalents, marketable securities and interest
receivable
$
450,315
$
400,508
Total assets
673,481
590,395
Total stockholders' equity
445,748
367,257
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190807005805/en/
Investor Relations – United States
McDavid Stilwell 510-970-6000, x219 mstilwell@sangamo.com
Media Inquiries – United States
Aron Feingold 510-970-6000, x421 afeingold@sangamo.com
Investor Relations and Media Inquiries –
European Union Caroline Courme 33 4 97 21 27 27
ccourme@sangamo.com
Sangamo Therapeutics (NASDAQ:SGMO)
Historical Stock Chart
From Aug 2024 to Sep 2024
Sangamo Therapeutics (NASDAQ:SGMO)
Historical Stock Chart
From Sep 2023 to Sep 2024