RICHMOND, Calif., Aug. 9, 2017 /PRNewswire/ -- Sangamo
Therapeutics, Inc. (NASDAQ: SGMO) today reported its second quarter
2017 financial results and recent accomplishments.
"In the second quarter we strengthened our balance sheet in
order to position Sangamo for the rapid development of our
therapeutic pipeline," said Dr. Sandy
Macrae, CEO of Sangamo. "Operationally, we are activating
multiple sites across the country for each of our four clinical
trials. Patients are being screened and qualified for enrollment,
and we expect to report data from these studies late this year or
in the first half of 2018. We are also making progress advancing
product candidates in our middle pipeline, which include our wholly
owned AAV gene therapy for Fabry disease and autologous genome
edited stem cell treatments for beta-thalassemia and sickle cell
disease in partnership with Bioverativ."
Recent Accomplishments
- Established an exclusive, global collaboration and license
agreement with Pfizer Inc. for the development and
commercialization of gene therapy programs for hemophilia A,
including SB-525. Sangamo received a $70
million upfront payment and is eligible to receive up to
$475 million in milestone payments,
as well as tiered, double digit royalties on net sales.
- Further strengthened balance sheet through public offering of
common stock raising net proceeds of approximately $78.1 million.
- Received Fast Track designation from the FDA for SB-318 and
SB-913, in vivo genome editing product candidates for the
treatment of MPS I and MPS II, and for SB-525, gene therapy product
candidate for hemophilia A. Fast Track designation is designed to
facilitate the development and expedite the review of drugs and
biologics to treat serious conditions and fill an unmet medical
need.
- Received Orphan Medicinal Product designation (OMPD) from the
European Medicines Agency for SB-525 gene therapy product candidate
for hemophilia A. Similar to the FDA's Orphan Drug designation,
OMPD provides incentives to advance the development and
commercialization of orphan medicines, and also includes access to
the EU centralized authorization procedure and potential for market
exclusivity for a period of up to ten years.
- Appointed Dr. Roger Jeffs and
Joseph Zakrzewski to Sangamo's Board
of Directors, bringing extensive experience in therapeutic product
development and commercialization to Sangamo's leadership.
Second Quarter 2017 Financial Results
For the second quarter ended June 30,
2017, Sangamo reported a consolidated net loss of
$12.5 million, or $0.17 per share, compared to a net loss of
$26.6 million, or $0.38 per share, for the same period in 2016. As
of June 30, 2017, the Company had
cash, cash equivalents, marketable securities and interest
receivable of $266.5 million.
Revenues for the second quarter of 2017 were $8.3 million, compared to $3.7 million for the same period in 2016. Second
quarter 2017 revenues were generated from Sangamo's collaboration
agreements with Pfizer, Bioverativ, Shire International (Shire) and
Sigma-Aldrich, as well as the Company's research grants. The
revenues recognized for the second quarter of 2017 consisted of
$8.0 million in collaboration
agreements and $0.3 million in
research grants, compared to $3.6
million and $0.1 million,
respectively, for the same period in 2016.
For the second quarter of 2017, Sangamo recognized $3.1 million of revenues related to research
services performed under the collaboration agreement with
Bioverativ. Sangamo received upfront payments of $13.0 million, $20.0
million and $70.0 million
pursuant to the agreements entered into with Shire in 2012, Biogen
(the predecessor of Bioverativ) in 2014, and Pfizer in May 2017, respectively. The Shire payment is
being recognized as revenue on a straight-line basis through
approximately December 2017.
Beginning in January 2017, the Biogen
agreement was transferred to Bioverativ, and the remaining upfront
payment is being recognized through approximately June 2020. The Pfizer upfront payment is being
recognized as revenue on a straight-line basis through
approximately December 2019. The
Company recognized $0.6 million of
the Shire upfront payment, $0.4
million of the Bioverativ upfront payment, and $3.8 million of the Pfizer upfront payment as
revenues for the second quarter of 2017.
Research and development expenses were $15.0 million for the second quarter of 2017,
compared to $19.5 million for the
same period in 2016. The decrease was primarily due to the
completion of external GMP manufacturing expenses associated with
the Company's 2017 clinical studies.
General and administrative expenses were $6.0 million for the second quarter of 2017,
compared to $11.1 million for the
same period in 2016. The decrease was primarily due to decreases in
stock-based compensation and salaries and benefits, including those
associated with the transition of the Company's former chief
executive officer.
Total operating expenses for the second quarter of 2017 were
$21.0 million, compared to
$30.5 million for the same period in
2016.
Financial Guidance for 2017
The Company updates guidance as follows:
- Revenues: The Company expects that revenues will be in
the range of $30 million to $40
million in 2017, inclusive of research funding from existing
collaborations.
- Operating Expenses: Sangamo expects that operating
expenses will be in the range of $90 million
to $100 million for 2017, including non-cash stock-based
compensation expense.
- Cash and Investments: Sangamo expects that its cash,
cash equivalents and marketable securities will be at least
$220 million at the end of 2017. This
anticipated cash balance is inclusive of research funding from
existing collaborators but exclusive of funds arising from any
additional new collaborations or partnerships or other sources of
capital.
Conference Call
Sangamo will host a conference call today, August 9, 2017, at 5:00
p.m. ET, 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. A replay of the webcast will also be
available for one week after the call. During the conference call,
the Company will review these results, discuss other business
matters and provide guidance with respect to 2017.
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 54328579. 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
August 9, 2017 to 11:59 p.m. ET on August
16, 2017. 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
54328579.
About Sangamo Therapeutics
Sangamo Therapeutics, Inc. is focused on translating
ground-breaking science into genomic therapies that transform
patients' lives using the company's industry leading platform
technologies in genome editing, gene therapy, gene regulation and
cell therapy. For more information about Sangamo, visit the
Company's website at www.sangamo.com.
This press release contains forward-looking statements
regarding Sangamo's current expectations. These forward looking
statements include, without limitation, references to the expected
timing of presentation of clinical trial data, the expected
accomplishment in 2017, anticipated cash and investment balance,
operating expenses, revenue and potential milestone and royalty
payments under Sangamo's agreements with Shire, Bioverativ and
Pfizer. 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 of lead programs, the lengthy and
uncertain regulatory approval process, uncertainties related to the
initiation and completion of clinical trials, whether clinical
trial results will validate and support the safety and efficacy of
Sangamo's therapeutics, and the ability to establish 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 gene-based
therapeutics. 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 Reports on Form 10-K and Quarterly Reports on Form 10-Q as
filed with the Securities and Exchange Commission. 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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Three Months
Ended
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|
Six Months
Ended
|
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June
30,
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|
June
30,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Statement of
Operations Data:
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|
|
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|
|
|
Revenues:
|
|
|
|
|
|
|
|
Collaboration
agreements
|
$
7,977
|
|
$
3,592
|
|
$
11,283
|
|
$
7,303
|
Research
grants
|
276
|
|
110
|
|
395
|
|
341
|
Total
revenues
|
8,253
|
|
3,702
|
|
11,678
|
|
7,644
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
14,984
|
|
19,454
|
|
27,926
|
|
34,720
|
General and
administrative
|
6,037
|
|
11,090
|
|
13,312
|
|
16,447
|
Total operating
expenses
|
21,021
|
|
30,544
|
|
41,238
|
|
51,167
|
Loss from
operations
|
(12,768)
|
|
(26,842)
|
|
(29,560)
|
|
(43,523)
|
Interest and other
income, net
|
277
|
|
243
|
|
437
|
|
430
|
Loss before
taxes
|
(12,491)
|
|
(26,599)
|
|
(29,123)
|
|
(43,093)
|
Benefit from income
taxes
|
-
|
|
24
|
|
-
|
|
24
|
Net loss
|
$
(12,491)
|
|
$
(26,575)
|
|
$
(29,123)
|
|
$
(43,069)
|
Basic and diluted net
loss per common share
|
$
(0.17)
|
|
$
(0.38)
|
|
$
(0.41)
|
|
$
(0.61)
|
|
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per common share
|
72,527
|
|
70,487
|
|
71,780
|
|
70,430
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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SELECTED BALANCE
SHEET DATA
|
|
|
|
|
|
|
|
|
June 30,
2017
|
|
December 31,
2016
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents, marketable securities and interest
receivable
|
$
266,510
|
|
$
142,759
|
|
|
|
|
Total
assets
|
282,993
|
|
157,891
|
|
|
|
|
Total stockholders'
equity
|
194,040
|
|
136,195
|
|
|
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SOURCE Sangamo Therapeutics, Inc.