Sangamo Therapeutics Reports Recent Business Highlights and First Quarter 2021 Financial Results
Conference Call and Webcast Scheduled for
“This quarter, we have continued our focus on advancing our lead programs through clinical execution, regulatory interactions, and collaborations with our partners and investigators. We are pleased that enrollment has completed for Pfizer’s lead-in study for the hemophilia A Phase 3 AFFINE trial. Additionally, the EMA granted Orphan Designation and the FDA granted Fast Track Designation to BIVV003, now known as
Recent Business Highlights
- Completed enrollment of patients in Pfizer’s lead-in study to the registrational Phase 3 AFFINE clinical trial of giroctocogene fitelparvovec, a gene therapy product candidate for the treatment of severe hemophilia A, developed in collaboration with Pfizer.
-
Received Fast Track Designation from the FDA for BIVV003, now known as
SAR445136 , our cell therapy product candidate for the treatment of sickle cell disease, developed in collaboration with Sanofi. Also, the EMA granted Orphan Designation toSAR445136 based on early clinical data from three treated patients. - Initiated the Phase 1/2 STEADFAST clinical study evaluating TX200, a wholly-owned autologous HLA-A2 CAR-Treg cell therapy product candidate treating patients receiving a HLA-A2 mismatched kidney from a living donor. The first patient is expected to be enrolled in this study by the end of this year.
-
Published preclinical data on tau- and alpha-synuclein-targeted zinc finger transcriptional repressors in Science Advances and at the 15th
International Conference on Alzheimer’s & Parkinson’s Diseases (ADPD), respectively. Also, announced upcoming preclinical alpha-synuclein and C9ORF72 abstracts to be presented at the upcoming 24th Annual Meeting of theAmerican Society of Gene & Cell Therapy (ASGCT ) onMay 11, 2021 .
First Quarter 2021 Financial Results
Consolidated net loss for the first quarter ended
Revenues
Revenues for the first quarter ended
GAAP and Non-GAAP operating expenses
Three Months Ended |
||||||||
(In millions) |
2021 |
2020 |
||||||
Research and development |
$ |
56.5 |
|
$ |
41.5 |
|
||
General and administrative |
|
16.1 |
|
|
16.1 |
|
||
Total operating expenses |
|
72.6 |
|
|
57.6 |
|
||
Stock-based compensation expense |
|
(7.5 |
) |
|
(5.6 |
) |
||
Non-GAAP operating expenses |
$ |
65.1 |
|
$ |
52.0 |
|
Total operating expenses on a GAAP basis for the first quarter ended
The increase in total operating expenses on a GAAP basis was primarily driven by our higher clinical and manufacturing supply expenses to support the advancement of our clinical trials and our new collaborations along with our increased headcount.
Cash, cash equivalents and marketable securities
Cash, cash equivalents and marketable securities as of
Guidance for 2021 Reiterated (initial guidance provided on
On a GAAP basis, we expect total operating expenses, including non-cash stock-based compensation expenses, to be in the range of approximately
On a non-GAAP basis, we expect total operating expenses, excluding estimated non-cash stock-based compensation expense of approximately
Conference Call
Sangamo will host a conference call today,
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 5714729. Participants may access the live webcast via a link on the
About
Forward-Looking Statements
This press release contains forward-looking statements regarding our current expectations. These forward-looking statements include, without limitation, statements relating to advancing our clinical programs, the therapeutic potential of our product candidates, anticipated plans and timeline for enrolling and conducting clinical trials, our 2021 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 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 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
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 | ||||||||
2021 |
2020 |
|||||||
Revenues |
$ |
26,280 |
|
$ |
13,076 |
|
||
Operating expenses: | ||||||||
Research and development |
|
56,434 |
|
|
41,479 |
|
||
General and administrative |
|
16,148 |
|
|
16,119 |
|
||
Total operating expenses |
|
72,582 |
|
|
57,598 |
|
||
Loss from operations |
|
(46,302 |
) |
|
(44,522 |
) |
||
Interest and other income, net |
|
625 |
|
|
1,548 |
|
||
Loss before taxes |
|
(45,677 |
) |
|
(42,974 |
) |
||
Income tax expense |
|
262 |
|
|
- |
|
||
Net loss |
|
(45,939 |
) |
|
(42,974 |
) |
||
Net loss attributable to non-controlling interest |
|
(6 |
) |
|
(61 |
) |
||
Net loss to |
$ |
(45,933 |
) |
$ |
(42,913 |
) |
||
Basic and diluted net loss per share attributable to |
$ |
(0.32 |
) |
$ |
(0.37 |
) |
||
Shares used in computing basic and diluted net loss per share attributable to |
|
143,112 |
|
|
116,060 |
|
||
Selected Balance Sheet Data: | ||||||||
|
|
|||||||
Cash, cash equivalents and marketable securities |
$ |
629,515 |
|
$ |
691,953 |
|
||
Total assets |
$ |
877,095 |
|
$ |
938,550 |
|
||
Total stockholders' equity |
$ |
469,417 |
|
$ |
497,366 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20210504006117/en/
Investor Relations & Media Inquiries
628.252.7494
afeingold@sangamo.com
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