Sangamo Therapeutics Reports Business Highlights and Third Quarter 2020 Financial Results
Conference Call and Webcast Scheduled for
“We are pleased with the clinical execution momentum across our portfolio, including the first patient dosed in the registrational AFFINE study of our investigational hemophilia A gene therapy partnered with Pfizer, as well as dosing of the first two patients in the Phase 1/2 STAAR study evaluating our Fabry disease gene therapy,” said
Business Updates
-
Earned a
$30 million milestone from Pfizer for the dosing of the first patient in the registrational Phase 3 AFFINE study of investigational hemophilia A gene therapy giroctocogene fitelparvovec (SB-525). - Pfizer provided updated data from the Phase 1/2 Alta study of giroctocogene fitelparvovec demonstrating tolerability, clinically meaningful factor levels with no bleeds and no prophylactic factor use through up to 85 weeks in the longest patient treated in the highest dose cohort.
- Completed dosing of the first two patients in our Phase 1/2 STAAR study evaluating our investigational ST-920 gene therapy in Fabry disease.
- Received additional regulatory approvals supporting the first-in-human Phase 1/2 STEADFAST study evaluating our CAR-Treg product candidate TX200 in kidney transplantation.
-
Completed our research activities in our collaboration with Pfizer to develop gene regulation therapies using zinc finger protein transcription factors for the treatment of C9ORF72-related Amyotrophic Lateral Sclerosis (ALS). Earned a
$5 million milestone related to the program. - Appointed Dr. Kenneth Hillan MB ChB, to our Board of Directors.
Third Quarter 2020 Financial Results
Cash, cash equivalents and marketable securities were
Consolidated net loss attributable to Sangamo for the third quarter ended
|
Three Months Ended September |
|
Nine Months Ended September |
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| (In millions) |
|
2020 |
|
2019 |
|
|
|
2020 |
|
2019 |
|
|||||
| Research and development |
$ |
45.3 |
$ |
36.3 |
|
$ |
128.3 |
$ |
107.6 |
|
||||||
| General and administrative |
|
16.2 |
|
14.9 |
|
|
50.2 |
|
46.6 |
|
||||||
| Total operating expenses |
|
61.5 |
|
51.2 |
|
|
178.5 |
|
154.2 |
|
||||||
| Stock-based compensation expense |
|
(6.7 |
) |
|
(4.7 |
) |
|
(19.1 |
) |
|
(14.1 |
) |
||||
| Non-GAAP operating expenses |
$ |
54.8 |
$ |
46.5 |
|
$ |
159.4 |
$ |
140.1 |
|
||||||
Total operating expenses were
Revised Financial Guidance for 2020
We are revising our full year operating expense guidance initially provided on
|
(In millions) |
Initially Provided |
Revised on |
Updated on |
|||
|
Estimated GAAP Operating Expenses |
|
|
|
|||
|
Estimated Non-GAAP Operating Expenses* |
|
|
|
|||
|
*(excludes estimated stock-based compensation of |
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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 2575067. Participants may access the live webcast via a link on the
About
Forward-Looking Statements
This press release contains forward-looking statements regarding Sangamo’s current expectations. These forward-looking statements include, without limitation, statements relating to the potential clinical benefits and long-term durability of SB-525 therapy, anticipated plans and timelines of Sangamo and its collaborators for conducting clinical trials, the potential to receive milestone payments under our collaborations with Pfizer and the timing of such payments, Sangamo’s financial resources and expectations, Sangamo’s 2020 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 its collaborators, including the initiation and operation of clinical trials; the research and development process; the uncertain timing and unpredictable results of clinical trials, including whether final clinical trial data will validate the safety and efficacy of product candidates; the regulatory approval process for clinical trials and product candidates; the manufacturing of products and product candidates; the commercialization of approved products; the potential for technological developments that obviate technologies used by Sangamo and its collaborators; the potential for Sangamo or its collaborators to breach or terminate collaboration agreements; the potential for Sangamo to fail to realize its expected benefits of its collaborations; and Sangamo’s ability to achieve expected future financial performance.
There can be no assurance that Sangamo and its collaborators will be able to develop commercially viable products. Actual results may differ from those projected in forward-looking statements due to risks and uncertainties that exist in the operations and business environments of Sangamo and its collaborators. These risks and uncertainties are described more fully in Sangamo’s
Non-GAAP Financial Measures
To supplement Sangamo’s financial results and guidance presented in accordance with GAAP, Sangamo presents non-GAAP total operating expenses, which exclude stock-based compensation expense from GAAP total operating expenses. Sangamo believes that this non-GAAP financial measure, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Sangamo’s results from period to period and to its forward-looking guidance, and to identify operating trends in Sangamo’s business. Sangamo has 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. Sangamo encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information, to more fully understand Sangamo’s business.
| SELECTED CONSOLIDATED FINANCIAL DATA | ||||||||||||||||
| (unaudited; in thousands, except per share data) | ||||||||||||||||
| Statement of Operations Data: | ||||||||||||||||
|
Three months ended |
Nine Months Ended |
|||||||||||||||
|
|
|
|||||||||||||||
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|||||
| Revenues |
$ |
57,763 |
|
$ |
21,958 |
|
$ |
92,392 |
|
$ |
47,577 |
|
||||
| Operating expenses: | ||||||||||||||||
| Research and development |
|
45,287 |
|
|
36,288 |
|
|
128,289 |
|
|
107,593 |
|
||||
| General and administrative |
|
16,177 |
|
|
14,918 |
|
|
50,223 |
|
|
46,633 |
|
||||
| Total operating expenses |
|
61,464 |
|
|
51,206 |
|
|
178,512 |
|
|
154,226 |
|
||||
| Loss from operations |
|
(3,701 |
) |
|
(29,248 |
) |
|
(86,120 |
) |
|
(106,649 |
) |
||||
| Interest and other income, net |
|
2,430 |
|
|
1,887 |
|
|
5,910 |
|
|
6,729 |
|
||||
| Loss before taxes |
|
(1,271 |
) |
|
(27,361 |
) |
|
(80,210 |
) |
|
(99,920 |
) |
||||
| Income tax expense |
|
(237 |
) |
|
— |
|
|
(237 |
) |
|
— |
|
||||
| Net loss |
|
(1,508 |
) |
|
(27,361 |
) |
|
(80,447 |
) |
|
(99,920 |
) |
||||
| Net income (loss) attributable to non-controlling interests |
|
42 |
|
|
(54 |
) |
|
(55 |
) |
|
(179 |
) |
||||
| Net loss attributable to |
$ |
(1,550 |
) |
$ |
(27,307 |
) |
$ |
(80,392 |
) |
$ |
(99,741 |
) |
||||
| Basic and diluted net loss per common share attributable to |
$ |
(0.01 |
) |
$ |
(0.24 |
) |
$ |
(0.61 |
) |
$ |
(0.90 |
) |
||||
| Shares used in computing basic and diluted net loss per share attributable to |
|
141,100 |
|
|
115,710 |
|
|
132,079 |
|
|
110,837 |
|
||||
| Balance Sheet Data: | ||||||
| Cash, cash equivalents and marketable securities |
$ |
694,588 |
$ |
384,306 |
||
| Total assets |
|
963,710 |
|
637,516 |
||
| Total stockholders' equity |
|
520,881 |
|
432,739 |
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20201104005034/en/
Investor Relations & Media Inquiries
628.252.7494
afeingold@sangamo.com
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