Sangamo Therapeutics Reports Fourth Quarter And Full Year 2018 Financial Results
Recent Highlights
- ST-920 IND acceptance:
The U.S. Food and Drug Administration (FDA ) accepted the Investigational New Drug application (IND) for ST-920, a gene therapy candidate being evaluated for the treatment of adults with Fabry disease. Sangamo expects to initiate the Phase 1/2 clinical trial evaluating ST-920 later this year. - WORLDSymposium presentations: At the WORLDSymposium earlier in February, Sangamo presented interim results from the Phase 1/2 CHAMPIONS and EMPOWERS studies evaluating SB-913 and SB-318, zinc finger nuclease (ZFN) in vivo genome editing product candidates for the treatment of Mucopolysaccharidosis Type II (MPS II) and MPS I, respectively. Sangamo believes data from these two studies provide complementary evidence supportive of a favorable safety profile and of the activity of the ZFN in vivo genome editing approach used in both SB-913 and SB-318.
- EVP of R&D appointment: Sangamo appointed
Adrian Woolfson , BM BCh, PhD, as Executive Vice President of Research and Development. - Completion of acquisition of TxCell: In the fourth quarter of 2018, Sangamo completed the acquisition of
TxCell, SA . The acquisition positions Sangamo as a leader in the development of CAR-Tregs, which the Company plans to evaluate for solid organ transplant rejection and for autoimmune diseases.
"The enrollment of patients last year into our five active clinical trials has laid the foundation for a steady flow of data readouts in 2019," said
Anticipated Milestones in 2019
In Vivo Genome Editing
- SB-913: Nine patients are enrolled in the CHAMPIONS Study evaluating SB-913 for MPS II, including three patients who recently entered the study in the expanded high-dose cohort. In 2019, Sangamo expects to report longer-term safety and biochemical measurements, as well as analyses of liver biopsies and enzyme replacement therapy withdrawal experience.
- SB-318: Three patients are enrolled in the EMPOWERS Study evaluating SB-318 for MPS I. In 2019, Sangamo expects to report longer-term safety and biochemical measurements, as well as analyses of liver biopsies and enzyme replacement therapy withdrawal experience.
- SB-FIX: One patient is currently enrolled in the FIXtendz Study evaluating SB-FIX for hemophilia B. Sangamo expects to enroll a second subject in the study and later in 2019 to report data including safety and factor expression levels.
- Second-generation reagents for in vivo genome editing platform: Sangamo has developed second-generation albumin locus ZFN constructs for potential use in the ongoing in vivo genome editing development programs. The Company plans to initiate a clinical trial this year using these second-generation ZFNs that should enable a Phase 3 decision for the MPS II program in 2020.
Gene Therapy
- SB-525: Eight patients are enrolled in the Alta Study evaluating SB-525 gene therapy for hemophilia A, being developed in collaboration with Pfizer. In 2019, Sangamo expects to report data including safety and factor expression levels, as well as information regarding factor replacement use and bleeding events.
- ST-920: In 2019, Sangamo anticipates activating sites for the Phase 1/2 clinical trial evaluating ST-920 gene therapy for the treatment of Fabry disease.
Ex Vivo Cell Therapy
- ST-400 and BIVV003: ST-400 and BIVV003 are gene-edited cell therapies being developed in collaboration with
Sanofi for the treatment of beta thalassemia and sickle cell disease. Sangamo has enrolled two patients in the Thales Study evaluating ST-400 for the treatment of beta thalassemia and in 2019 expects to report initial safety and efficacy data including levels of fetal hemoglobin and total hemoglobin. BIVV003 is being evaluated for the treatment of sickle cell disease in the Phase 1/2 PRECIZN-1 trial run bySanofi . - TX200: In 2019, Sangamo anticipates filing a clinical trial application in
Europe for TX200, an autologous CAR-Treg cell therapy for the prevention of solid organ transplant rejection. The Company expects to activate clinical sites by year-end. - KITE-037: Kite, a
Gilead Company , has announced the intention to file an IND for KITE-037, an allogeneic anti-CD19 CAR-T cell therapy, in the latter half of 2019.
Fourth Quarter 2018 Financial Results
For the fourth quarter ended
Revenues for the fourth quarter ended
Total operating expenses for the fourth quarter ended
Full Year 2018 Results
For the year ended
Financial Guidance for 2019
- Operating Expense: Sangamo expects operating expense of
$210 to 220 million for the year endingDecember 31, 2019 . - Cash and Investments: Sangamo projects that current cash, cash equivalents, marketable securities and interest receivable position should last at least two years.
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 6875578. 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
About
Forward-Looking Statements
This press release contains forward-looking statements regarding Sangamo's current expectations. These forward-looking statements include, without limitation, statements regarding the initiation of clinical trials and activation of clinical trial sites in 2019, the expected disease targets for our product candidates, the presentation of clinical trial data from clinical trials in 2019, enrollment expectations in 2019, the filing of a clinical trial application in the
SELECTED CONSOLIDATED FINANCIAL DATA |
|||||||
(unaudited; in thousands, except per share data) |
|||||||
Statement of Operations Data: |
|||||||
Three months ended |
For the Year Ended |
||||||
December 31, |
December 31, |
||||||
2018 |
2017 |
2018 |
2017 |
||||
Revenues: |
|||||||
Collaboration agreements |
$ 26,687 |
$ 12,918 |
$ 84,065 |
$ 35,960 |
|||
Research grants |
150 |
159 |
387 |
607 |
|||
Total revenues |
26,837 |
13,077 |
84,452 |
36,567 |
|||
Operating expenses: |
|||||||
Research and development |
33,254 |
19,377 |
114,866 |
65,728 |
|||
General and administrative |
14,355 |
7,466 |
46,736 |
27,200 |
|||
Total operating expenses |
47,609 |
26,843 |
161,602 |
92,928 |
|||
Loss from operations |
(20,772) |
(13,766) |
(77,150) |
(56,361) |
|||
Interest and other income, net |
1,553 |
675 |
8,261 |
1,793 |
|||
Net loss |
(19,219) |
(13,091) |
(68,889) |
(54,568) |
|||
Net loss attributable to non-controlling interest |
(555) |
— |
(555) |
— |
|||
Net loss attributable to Sangamo Therapeutics, Inc. stockholders |
$ (18,664) |
$ (13,091) |
$ (68,334) |
$ (54,568) |
|||
Basic and diluted net loss per common share |
$ (0.18) |
$ (0.15) |
$ (0.70) |
$ (0.70) |
|||
Shares used in computing basic and diluted net loss per common share |
102,057 |
84,820 |
96,941 |
78,084 |
|||
SELECTED BALANCE SHEET DATA |
|||||||
Year Ended December 31, |
|||||||
2018 |
2017 |
||||||
(in thousands) |
|||||||
Cash, cash equivalents, marketable securities and interest receivable |
$ 400,508 |
$ 244,560 |
|||||
Total assets |
590,395 |
286,741 |
|||||
Total stockholders' equity |
366,518 |
187,900 |
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SOURCE
Sangamo Therapeutics, Inc. , Investors: McDavid Stilwell, 510-970-6000, x219, mstilwell@sangamo.com or Varant Shirvanian, 510-970-6000 x205, vshirvanian@sangamo.com or Media: Aron Feingold, 510-970-6000, x421, afeingold@sangamo.com