- Strong clinical momentum continues in Phase 1/2 STAAR study in
Fabry disease with 20 patients dosed in total.
- Dosed third patient in cohort 1 of Phase 1/2 CAR-Treg STEADFAST
study for TX200 in HLA A2 mismatched kidney transplantation.
- Unveiled Nav1.7 target to treat chronic neuropathic pain as
flagship program of wholly owned neurology epigenetic regulation
pipeline, with IND submission expected in 2024.
- Announced strategic pipeline prioritization and corporate
restructuring, including US workforce reduction of approximately
27%.
- Conference call and webcast scheduled for Thursday, April 27 at
8:30 a.m. Eastern Time.
Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicines
company, today announced recent business highlights, including a
strategic pipeline prioritization and restructuring, and reported
certain preliminary first quarter 2023 financial results.
“This quarter, Sangamo continued to advance its clinical and
pre-clinical pipeline. Our Phase 1/2 Fabry study continues to
enroll and dose patients, alongside preparations for a potential
Phase 3 trial expected to commence by the end of 2023. We
successfully dosed the third patient with TX200, our CAR-Treg
therapy in kidney transplantation, and received positive regulatory
feedback from the first two European authorities required to
accelerate the dose escalation. We are also excited to unveil Nav
1.7 as the prioritized target in our wholly owned neurology
epigenetic regulation pipeline,” said Sandy Macrae, Chief Executive
Officer of Sangamo. “Today’s environment necessitates careful
choices when deciding how many programs to take forward at once. We
are therefore announcing a sharpened strategic focus, prioritizing
our investments in our most promising programs. This has led to
difficult, but necessary, decisions to step away from certain
pre-clinical assets, shrink parts of our infrastructure and
redeploy investments towards realizing the full potential of what
we believe are our most valuable programs.”
The restructuring announced today is the result of a strategic
decision to increase focus on three key areas: Nav 1.7 and Prion as
cornerstones to the neurology epigenetic regulation portfolio;
Fabry Phase 3 readiness; and the TX200 CAR-Treg clinical study,
alongside a broader rightsizing of resources and investments across
the company. Additionally, Sangamo expects to significantly reduce
its internal manufacturing and allogeneic research footprints in
California. As a result of this restructuring, Sangamo is reducing
its US workforce by approximately 27%, or approximately 120 roles.
These actions are in addition to the previously announced portfolio
prioritization which resulted in the decision to seek a partner for
our sickle cell disease program. In addition, R. Andrew Ramelmeier,
Ph.D., Executive Vice President, Technical Operations will be
leaving the company on July 10, 2023. Phillip Ramsey, currently
serving as Vice President, Technical Development, has been
appointed as Head of Technical Operations effective May 29,
2023.
The restructuring plus other planned cost reduction initiatives
are expected to result in annualized savings of approximately $31
million. Sangamo believes its available cash, cash equivalents and
marketable securities as of March 31, 2023, in combination with the
other expected cost reductions, will be sufficient to fund its
planned operations for at least the next 12 months. Sangamo expects
to incur approximately $5 million - $7 million in one-time
restructuring costs in the second and third quarters of 2023.
Sangamo is assessing ways to further reduce annual operating
expenses, consistent with the prioritized objectives and progress
of the company.
“I am grateful to all our employees for their commitment to
Sangamo and dedication to patients, and have special gratitude to
those who are leaving for all they have done to advance our
mission. Additionally, I would like to personally thank Andy for
the passion, dedication and leadership he has brought to Sangamo.
He leaves a great legacy of technical excellence and I wish him
well in the future.”
Recent Business Highlights
Neurology Epigenetic Regulation Programs – Unveiled
Nav1.7 program to treat chronic neuropathic pain as flagship
program in prioritized wholly owned neurology pipeline; made
strategic decision to pause further development of other
pre-clinical programs following conclusion of collaborations with
Biogen and Novartis.
- Announced Nav1.7 to treat chronic neuropathic pain as flagship
program in Sangamo’s newly prioritized wholly owned neurology
pipeline, with an IND submission expected in 2024. First data from
this program expected to be published via a platform presentation
at the upcoming American Society for Cell and Gene Therapy (ASGCT)
26th Annual Meeting in Los Angeles in May 2023.
- Advanced wholly owned prion disease program, with an IND
submission anticipated in 2025.
- Continued to advance identification and selection of engineered
AAV capsids for enhanced central nervous system delivery.
- Following a strategic portfolio evaluation, decided to pause
further development of programs previously partnered with Biogen
and Novartis, pending the identification of a suitable capsid for
delivery for those specific indications.
Fabry disease – Dosed three additional patients in Phase
1/2 STAAR study; advancing Phase 3 trial design planning in
anticipation of FDA meeting in the summer; expect to begin pivotal
trial by end of 2023.
- Dosed three additional patients in the dose expansion phase of
the Phase 1/2 STAAR study evaluating isaralgagene civaparvovec, our
wholly owned gene therapy product for the treatment of Fabry
disease, for a total of 20 patients dosed to date. We expect dosing
to conclude by the end of 2023.
- Plan to meet with the FDA on proposed Phase 3 study design in
the summer and anticipate commencement of the pivotal trial in the
second half of 2023, with dosing of the first patient expected to
start as early as the first part of 2024.
Renal Transplant Rejection – Dosed third patient in
cohort 1; preparations for higher dose cohort underway; efforts to
accelerate dose escalation advancing through regulatory reviews;
prioritizing near-term autologous portfolio, resulting in the
relocation of allogeneic development and manufacturing
activities.
- Dosed third patient in cohort 1 in the 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 product candidate continues to be generally well tolerated
in all three patients dosed to date.
- Received positive regulatory feedback for accelerated dose
escalation protocol from two European agencies to date.
- Plan to share initial data from cohort 1 by the end of
2023.
- Intend to prioritize near-term autologous portfolio, resulting
in decision to transition all remaining allogeneic research
activities from Sangamo US to Sangamo France, and to cease cell
therapy manufacturing in California.
Hemophilia A (Pfizer) – Dosing of patients in Phase 3
AFFINE trial to support primary analysis complete; pivotal data
read-out expected in mid-2024; BLA and MAA submissions anticipated
in second half of 2024.
- Dosing of patients to support primary analysis is complete in
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.
- A pivotal readout is expected in mid-2024, with Pfizer
anticipating BLA and MAA submissions in the second half of
2024.
American Society of Gene and Cell Therapy (ASGCT) 26th Annual
Meeting – 14 Sangamo abstracts accepted.
- A total of 14 Sangamo abstracts were accepted for presentation
at ASGCT on May 16-20, 2023, in Los Angeles, California, including
pre-clinical updates from our prioritized neurology programs Nav
1.7 and Prion, innovations in our epigenetic regulation platform
and advances in our AAV capsid engineering program.
Preliminary First Quarter 2023 Financial Results
Sangamo is in the process of completing its customary
quarter-end close and review procedures, including the evaluation
of non-cash charges related to impairment of long-lived assets, as
of and for the quarter ended March 31, 2023, and the final results
for this period could materially differ from the preliminary
expected results disclosed in this press release. Sangamo’s full
first quarter 2023 financial results will be reflected in a
Quarterly Report on Form 10-Q which is expected to be filed no
later than May 10, 2023. The financial performance measures
presented in this press release for the first quarter of 2023 are
forward-looking statements, preliminary estimates and unaudited,
based on management’s initial review of the information presented,
and are thus inherently uncertain and subject to change as Sangamo
completes its end-of-period reporting process and related
activities for the first quarter of 2023. During the course of the
review of Sangamo’s condensed consolidated financial statements and
related notes as of and for the quarter ended March 31, 2023,
Sangamo’s independent registered public accountants may identify
items that could cause final reported results to be materially
different from the preliminary estimates presented herein.
Additional information and disclosures would be required for a more
complete understanding of Sangamo’s financial position and results
of operations as of and for the quarter ended March 31, 2023.
Accordingly, undue reliance should not be placed on this
preliminary information.
Revenues
Revenues for the first quarter ended March 31, 2023, are
estimated to be approximately $158.0 million, compared to $28.2
million for the same period in 2022.
The estimated increase of $129.8 million in revenues is
primarily attributable to an increase of $121.1 million in revenue
relating to our collaboration agreement with Biogen, mainly due to
the impact of termination related contract modification, and an
increase of $6.0 million in revenue relating to our collaboration
agreement with Kite, mainly due to a reduction in the estimated
project costs, which resulted in an adjustment to the measure of
proportional cumulative performance.
Operating Expenses
Total operating expenses on a GAAP basis for the first quarter
ended March 31, 2023, are estimated to be in the range of $120
million to $140 million, compared to $73.5 million for the same
period in 2022.
The total estimated operating expenses on a GAAP basis for the
quarter included certain non-cash charges such as impairment of
goodwill of $38.1 million, and impairment of long-lived assets of
up to $20 million. These estimated charges are a result of the
termination of our collaboration agreements with Biogen and
Novartis, a sustained decline in our stock price and related market
capitalization and a general decline in equity values in the
biotechnology industry.
Cash, Cash Equivalents and Marketable Securities
Cash, cash equivalents and marketable securities as of March 31,
2023 were $241.0 million, compared to $307.5 million as of December
31, 2022.
Sangamo believes its available cash, cash equivalents and
marketable securities as of March 31, 2023, in combination with the
other expected cost reductions, will be sufficient to fund its
planned operations for at least the next 12 months.
Financial Guidance for 2023 Updated
In line with the business announcements outlined, we are
revising our full-year operating expense guidance as follows:
- GAAP operating expenses, including goodwill and long-lived
assets impairment charges and stock-based compensation expense, are
estimated to be in the range of approximately $315 million to $335
million (updated on April 26, 2023). The previous GAAP operating
expenses guidance provided on February 22, 2023 was in the range of
approximately $310 million to $330 million.
- Non-GAAP operating expenses are estimated to be in the range of
approximately $240 million to $260 million (updated on April 26,
2023). Estimated non-GAAP operating expenses exclude impairment of
goodwill of $38 million, impairment of long-lived assets of up to
$20 million and stock-based compensation expense of $35 million.
The previous non-GAAP operating expenses guidance provided on
February 22, 2023 was in the range of approximately $275 million to
$295 million.
Upcoming Events
Sangamo plans to participate in the following events:
Scientific / Medical Conferences
- ASGCT 26th Annual Meeting, Los Angeles, California, May 16-20,
2023
Investor Conferences
- 2023 Bank of America Global Healthcare Conference, May 9,
2023
- 2023 RBC Global Healthcare Conference, May 17, 2023
- 7th Annual Barclays Gene Editing and Gene Therapy Summit, May
24, 2023
- Stifel 2023 Tailoring Genes: Genetic Medicines Day, May 30,
2023
- Jefferies Global Healthcare Conference, June 8, 2023
- 2023 Wedbush Pacgrow Healthcare Conference, August 8-9,
2023
- 2023 Wells Fargo Healthcare Conference, September 6-8,
2023
Access links for available webcasts for these investor
conferences will be available on the Sangamo website in the
Investors and Media section under Events. Available materials will
be found on the Sangamo website after the event under
Presentations.
Conference Call to Discuss Business Updates and Preliminary
First Quarter 2023 Results
The Sangamo management team will discuss these business updates
and preliminary results on a conference call tomorrow, Thursday,
April 27, 2023, at 8:30 a.m. Eastern Time.
Participants should register for, and access, the call using
this link. While not required, it is recommended you join 10
minutes prior to the event start. Once registered, participants
will be given the option to either dial into the call with the
number and unique passcode provided or to use the dial-out option
to connect their phone instantly.
An updated corporate presentation is available in the Investors
and Media section under Presentations.
The link to access the live webcast can also be found on the
Sangamo website in the Investors and Media section under Events. A
replay will be available following the conference call, accessible
at the same link.
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. To learn more, visit www.sangamo.com and
connect with us on LinkedIn and Twitter.
Forward-Looking Statements
This press release contains forward-looking statements regarding
our current expectations. These forward-looking statements include,
without limitation, statements relating to: our preliminary
estimated operating results for the quarter ended March 31, 2023,
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
expectations regarding the conclusion of dosing in our Phase 1/2
STAAR study, preparations and plans for patient dosing in the
STEADFAST study and the potential for acceleration of the study
timeline, the anticipated advancement of our product candidates to
late-stage development, including potential future Phase 3 trials
of isaralgagene civaparvovec and the timing thereof, the
availability and presentation of data from the Phase 3 AFFINE
trial, and plans for a BLA and MAA submission for giroctocogene
fitelparvovec, expectations regarding advancement of our
preclinical neurology programs, including announcement of data
from, and anticipated IND submissions related to, such programs,
the potential for a partner for our sickle cell disease program;
expectations concerning our strategic prioritization and
restructuring, including plans to reduce our manufacturing and
allogenic research footprints and the expected charges and cost
savings associated with such restructuring, future cost reductions,
our expected cash runway, our 2023 financial guidance related to
GAAP and non-GAAP total operating expenses and stock-based
compensation, our plans to participate in industry and investor
conferences, 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
impediments to adjustments to Sangamo’s preliminary measures of
financial performance resulting from, among other things, the
completion of Sangamo’s financial close procedures; Sangamo’s
ability to execute its strategic prioritization and restructuring
as currently contemplated; the actual charges associated with the
restructuring being higher than anticipated or changes to the
assumptions on which the estimated charges associated with the
restructuring are based; Sangamo’s ability to achieve projected
cost savings in connection with the restructuring and to further
reduce operating expenses; unintended consequences from the
restructuring that impact Sangamo’s business; the effects of
macroeconomic factors or financial challenges, including as a
result of the ongoing conflict between Russia and Ukraine, the
COVID-19 pandemic and current or potential future bank failures, 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 impacts of clinical trial delays, pauses and holds on clinical
trial timelines and commercialization of product candidates; the
uncertain timing and unpredictable nature of clinical trial
results, including the risk that therapeutic effects in the Phase 3
AFFINE trial will not be durable in patients as well as the risk
that the therapeutic effects observed in the latest preliminary
clinical data from the Phase 1/2 STAAR study, including data from
kidney biopsies, and the Phase 1/2 PRECIZN-1 study will not be
durable in patients and that final clinical trial data from the
study will not validate the safety and efficacy of isaralgagene
civaparvovec, and that the patients withdrawn from ERT will remain
off ERT; 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 our product candidates; 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; our lack of
capital resources to fully develop, obtain regulatory approval for
and commercialize our product candidates, and our related need for
substantial additional funding to execute our operating plan and to
continue to operate as a going concern; our reliance on
collaborators and our potential inability to secure additional
collaborations, including for our sickle cell disease program; 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, or SEC, filings and reports, including in our
Annual Report on Form 10-K for the year ended December 31, 2022, as
supplemented by our Quarterly Report on Form 10-Q for the quarter
ended March 31, 2023 to be filed with the SEC, and future filings
and reports that Sangamo makes from time to time with the SEC.
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 Measures
To supplement our financial guidance presented in accordance
with GAAP, we present non-GAAP total operating expenses financial
guidance, which exclude stock-based compensation expense and
impairment of goodwill and long-lived assets from GAAP total
operating expenses. We believe that these non-GAAP financial
measures, 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, and we have excluded impairment of goodwill
and long-lived assets to facilitate a more meaningful evaluation of
our current operating performance and comparisons to our operating
performance in other periods. These non-GAAP financial measures are
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.
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Investor Relations & Media
Inquiries Louise Wilkie ir@sangamo.com media@sangamo.com
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