Conference Call and Webcast Scheduled for 4:30
p.m. Eastern Time
Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicines
company, today reported recent business highlights and first
quarter 2022 financial results.
“This quarter, we have continued to progress multiple programs
through clinical development and demonstrated, once again,
Sangamo’s track record of advancing groundbreaking therapies in
genomic medicine,” said Sandy Macrae, Chief Executive Officer of
Sangamo. “We dosed a total of five patients across three programs,
including the first patient in our study for the treatment of
kidney transplant rejection, in what we believe was the first in
human dosing of an engineered CAR-Treg cell therapy product
candidate. We believe this progress positions us well to advance
transformational genomic medicines for patients in need and to
generate long-term value for our shareholders.”
Recent Business Highlights
Fabry disease – Dosed three additional patients, resulting in a
total of nine patients dosed to date, thereby completing dose
escalation for the Phase 1/2 study; Phase 3 planning
progresses.
- We dosed two patients in Cohort 4 in the Phase 1/2 STAAR study
evaluating isaralgagene civaparvovec, our wholly owned gene therapy
product candidate for the treatment of Fabry disease, at a dose
level of 5e13 vg/kg.
- In addition, we dosed a third patient in Cohort 3, at the dose
level of 3e13 vg/kg.
- In total, we have successfully dosed a total of nine patients
across four cohorts to complete the dose escalation portion of the
study.
- Enzyme replacement therapy (ERT) withdrawal was completed for a
second patient, with no reports to date that the resumption of ERT
is required in either patient.
- We expect to provide updated results from the STAAR study in
the second half of 2022.
- We continue to actively prepare for the expansion cohorts, as
well as a potential pivotal Phase 3 trial.
Sickle cell disease – Dosed fifth patient, the first with a
product candidate manufactured using improved methods; Phase 3
planning progresses.
- We dosed the fifth patient in the Phase 1/2 PRECIZN-1 study of
SAR445136, a zinc finger nuclease gene-edited cell therapy
candidate for the treatment of sickle cell disease, which is under
development with Sanofi. This is the first patient in the study to
receive a product candidate manufactured using improved methods
that have been shown in internal experiments to increase the number
of long-term progenitor cells in the final product.
- We plan to dose the remaining patients in this study by the end
of the third quarter of 2022.
- We expect to provide updated results from the PRECIZN-1 study
in the second half of 2022.
- Phase 3 enabling activities and manufacturing readiness are in
progress.
- We continue to collaborate with Sanofi on an orderly transition
of Sanofi’s rights and obligations under this program back to
Sangamo on June 28.
Hemophilia A – FDA lifted clinical hold; Trial remains
voluntarily paused; Pfizer expects to resume trial in Q3 2022.
- Pfizer announced that, in March 2022, the FDA lifted the
clinical hold that had been placed on the Phase 3 AFFINE trial of
giroctocogene fitelparvovec, an investigational gene therapy we are
developing with Pfizer for patients with moderately severe to
severe hemophilia A. Pfizer previously paused this trial when some
of the patients experienced FVIII activity greater than 150%
following treatment.
- Pfizer also announced that the voluntary pause remains in place
until all necessary conditions are met, including approval of
updated trial protocols by regulatory authorities.
- In addition, Pfizer announced that a patient with elevated
FVIII levels reported a below-the-knee deep vein thrombosis. The
patient had a history of thrombotic events prior to participation
in the trial, which is a known risk factor for subsequent events
and an exclusion criterion for participation in the AFFINE trial.
The case was assessed to understand all potential contributing
factors, including missed doses of investigator-prescribed direct
oral anti-coagulants. The patient is reported to be doing well. The
information was shared with trial investigators, health authorities
and the independent external Data Monitoring Committee and Pfizer
responded to queries from health authorities.
- Pfizer announced that it anticipates resuming this trial in the
third quarter of 2022, with a pivotal data readout estimated in the
second half of 2023.
- Over 50% of the patients have been enrolled in the Phase 3
AFFINE trial.
Renal Transplant Rejection – Believed to be first-ever in human
dosing with an engineered CAR-Treg cell therapy candidate.
- We dosed the first patient in our Phase 1/2 STEADFAST study
evaluating TX200, our wholly owned autologous CAR-Treg cell therapy
treating patients receiving an HLA-A2 mismatched kidney from a
living donor.
- The patient continues to do well, and no adverse events related
to treatment have been reported.
- Dosing of the second patient is expected around the middle of
2022, based on their transplant schedule.
- We expect to complete dosing of the first cohort, comprised of
three patients, by the end of 2022.
American Society of Gene and Cell Therapy (ASGCT) – Eight
abstracts accepted.
- A total of eight Sangamo abstracts were accepted for
presentation at ASGCT on May 16-19, 2022, including pre-clinical
updates across our CAR-Treg autoimmune cell therapy platform,
innovations in our genome engineering platform and advances in our
AAV capsid engineering program.
First Quarter 2022 Financial Results
Consolidated net loss for the first quarter ended March 31, 2022
was $44.0 million, or $0.30 per share, compared to a net loss of
$45.9 million, or $0.32 per share, for the same period in 2021.
Revenues
Revenues for the first quarter ended March 31, 2022 were $28.2
million, compared to $26.3 million for the same period in 2021.
The increase of $2.0 million in revenues was primarily
attributed to an increase of $1.0 million related to our
collaboration agreement with Novartis, an increase of $0.7 million
related to our collaboration agreement with Biogen, and an increase
of $0.4 million related to our collaboration agreement with
Sanofi.
GAAP and Non-GAAP operating expenses
Three Months Ended March 31,
(In millions)
2022
2021
Research and development
$
58.6
$
56.5
General and administrative
14.9
16.1
Total operating expenses
73.5
72.6
Stock-based compensation expense
(7.7
)
(7.5
)
Non-GAAP operating expenses
$
65.8
$
65.1
Total operating expenses on a GAAP basis for the first quarter
ended March 31, 2022 were $73.5 million, compared to $72.6 million
for the same period in 2021. Non-GAAP operating expenses, which
exclude stock-based compensation expense, for the first quarter
ended March 31, 2022 were $65.8 million, compared to $65.1 million
for the same period in 2021.
The increase in total operating expenses on a GAAP basis was
primarily driven by our higher preclinical, clinical and lab supply
and other R&D expenses along with our increased headcount to
support the advancement of our clinical trials and our ongoing
collaborations. Manufacturing and overhead costs also increased as
we ramp up our internal manufacturing operations.
Cash, cash equivalents and marketable securities
Cash, cash equivalents and marketable securities as of March 31,
2022 were $400.3 million, compared to $464.7 million as of December
31, 2021.
Financial Guidance for 2022 Reiterated (initial guidance
provided on February 24, 2022)
On a GAAP basis, we continue to expect total operating expenses
in the range of approximately $320 million to $350 million in 2022,
which includes non-cash stock-based compensation expense.
We continue to expect non-GAAP total operating expenses,
excluding estimated non-cash stock-based compensation expense of
approximately $40 million, in the range of approximately $280
million to $310 million in 2022.
Conference Call
Sangamo will host a conference call today, May 5, 2022, at 4:30
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 3090098. 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 3090098.
About Sangamo Therapeutics
Sangamo Therapeutics is a clinical-stage biopharmaceutical
company with a robust genomic medicines pipeline. Using
ground-breaking science, including our proprietary zinc finger
genome engineering technology and manufacturing expertise, Sangamo
aims to create new genomic medicines for patients suffering from
diseases for which existing treatment options are inadequate or
currently don’t exist. 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: the therapeutic and
commercial potential of our product candidates, the anticipated
plans and timelines of Sangamo and our collaborators for screening,
enrolling and dosing patients in and conducting our ongoing and
potential future clinical trials and presenting clinical data from
our clinical trials, including plans for cohort expansion in, and
the presentation of updated clinical data from, the Phase 1/2 STAAR
study and updates regarding the PRECIZN-1 study, the dosing of
patients with product candidates using improved manufacturing
methods in the PRECIZN-1 study and the potential impacts thereof,
as well as the timing and expectations for completion of dosing in
such study, plans and timing for the transition of the SAR445136
program from Sanofi to Sangamo, the expected timeline for dosing
additional patients in the STEADFAST study, the anticipated
advancement of our product candidates to late-stage development
including potential future Phase 3 trials, plans and timing
regarding the submission of a protocol amendment in the Phase 3
AFFINE trial and the resumption of dosing of patients in and
presentation of data from such trial, our 2022 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 and other factors 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 the presentation of clinical data; the uncertain timing and
unpredictable nature of clinical trial results; the unpredictable
regulatory approval process for product candidates across multiple
regulatory authorities; reliance on results of early clinical
trials, which results are not necessarily predictive of future
clinical trial results, including the results of any Phase 3 trial
of isaralgagene civaparvovec; our limited experience manufacturing
biopharmaceutical products, including the risks that we may be
unable to maintain compliant manufacturing facilities, build
additional facilities and manufacture our product candidates as
intended; the potential for technological developments that obviate
technologies used by Sangamo; the potential for Sanofi and Sangamo
to fail to come to agreement on appropriate transition agreements
or to execute an orderly transition under their collaboration
agreement; the potential that Sangamo will not be able to identify
and secure options or new collaborators for the SAR445136 program;
the potential for Sangamo to cease development of the SAR445136
program, whether due to its inability to secure options to advance
the program or otherwise; our lack of resources to fully develop,
obtain regulatory approval for and commercialize our product
candidates; 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, 2021 as
supplemented by our Quarterly Report on Form 10-Q for the quarter
ended March 31, 2022. 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,
2022
2021
Revenues
$
28,231
$
26,280
Operating expenses: Research and development
58,584
56,434
General and administrative
14,908
16,148
Total operating expenses
73,492
72,582
Loss from operations
(45,261
)
(46,302
)
Interest and other income, net
1,342
625
Loss before income taxes
(43,919
)
(45,677
)
Income tax (benefit) expense
58
262
Net loss
$
(43,977
)
$
(45,939
)
Net loss attributable to non-controlling interest
-
(6
)
Net loss attributable to Sangamo Therapeutics, Inc. stockholders
$
(43,977
)
$
(45,933
)
Basic and diluted net loss per share attributable to Sangamo
Therapeutics, Inc. stockholders
$
(0.30
)
$
(0.32
)
Shares used in computing basic and diluted net loss per share
attributable to Sangamo Therapeutics, Inc. stockholders
146,218
143,112
Selected Balance Sheet Data:
March 31,
2022
December
31, 2021
Cash, cash equivalents, and marketable securities
$
400,311
$
464,717
Total assets
$
654,310
$
721,923
Total stockholders' equity
$
334,522
$
375,343
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version on businesswire.com: https://www.businesswire.com/news/home/20220505005845/en/
Investor Relations & Media
Inquiries Louise Wilkie ir@sangamo.com media@sangamo.com
Sangamo Therapeutics (NASDAQ:SGMO)
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