Recent Highlights
- Presentation of new data from Sangamo's proprietary In Vivo Protein Replacement Platform™ (IVPRP) programs for MPS I and MPS II at the 12th Annual WORLDSymposium™ Meeting. Sangamo scientists and academic collaborators from the
University of Minnesota presented new preclinical data in disease models of the Company's IVPRP-based MPS I (Hurler syndrome) and MPS II (Hunter syndrome) programs at the 2016 WORLDSymposium™ Annual Meeting. In animal models of disease, the data demonstrated the production of stable, therapeutic levels of replacement enzyme from the liver into the circulation and secondary tissues, including the brain, resulting in significant reduction in biomarkers of the disease, and notably, statistically significant improvements in cognitive function in treated animals. - Publication in the
New England Journal of Medicine (NEJM) highlighting Sangamo's IVPRP approach for hemophilia B. In March, NEJM published a review authored by Dr.Amit Nathwani , a key opinion leader in the field of gene therapy approaches to hemophilia, highlighting Sangamo's IVPRP-based SB-FIX program for the one-time, permanent treatment of hemophilia B. The article details the significant advantages of Sangamo's ZFN-mediated, targeted integration of the Factor IX (FIX) gene at the albumin locus over conventional non-integrating gene therapy approaches that use adeno-associated virus (AAV) to deliver the FIX gene and other therapeutic genes to liver cells. - Sangamo augments clinical expertise with the appointment of
Matthew Spear , M.D. as Vice President and Head of Clinical Development.Dr. Spear joins Sangamo with more than 20 years of experience in all stages of biopharmaceutical research and development and has led the development of over 15 therapeutic products. Most recently,Dr. Spear served as a Vice President in Clinical Development at Incyte Corp. - Presentation of immunological data from Sangamo's SB-728-T Phase 2 clinical program in HIV/AIDS at the 2016 Annual Conference on Retroviral and Opportunistic Infections (CROI 2016). Sangamo's collaborators from
Case Western Reserve University presented analyses of immunological data from the Company's clinical trials of SB-728-T, a ZFP Therapeutic® designed to provide functional control of HIV/AIDS. The presentation outlined potentially interrelated mechanisms for viral load (VL) control in SB-728-T-treated subjects during a treatment interruption (TI) from their antiretroviral therapy. This suggests a model mechanism of action for SB-728-T and enables identification of patients who will most benefit from Sangamo's ZFN-mediated CCR5 knock-out approach.
- Initiation of IVPRP-based Phase 1/2 clinical trials SB-FIX-1501 (hemophilia B) and SB-318-1502 (MPS I / Hurler syndrome) by the end of the second quarter and mid-2016, respectively.
- Presentation of data from several ZFP Therapeutic programs by Sangamo scientists and collaborators at the upcoming 19th Annual Meeting of the
American Society of Gene & Cell Therapy (ASGCT), which will be held inWashington D.C. fromMay 4-7, 2016 . - Submission of investigational new drug (IND) applications in the first half of 2016 for Sangamo's IVPRP-based SB-913 program for MPS II (Hunter syndrome), and beta-thalassemia program in collaboration with Biogen Inc. (Biogen).
- Presentation of new clinical data from Cohort 3* of Sangamo's SB-728-1101 Phase 1/2 trial in T-cells for the functional control of HIV/AIDS in the second half of 2016.
Revenues for the first quarter of 2016 were
The decrease in collaboration agreement revenues was primarily a result of an amendment to the Company's collaboration and license agreement with Shire in the third quarter of 2015, which returned the rights to the hemophilia programs to Sangamo, and a decrease in revenue under the Company's collaboration agreement with Sigma.
In the first quarter of 2016, Sangamo recognized
Research and development expenses were
General and administrative expenses were
Total operating expenses for the first quarter of 2016 were
Financial Guidance for 2016 The Company reiterates its earlier guidance as follows:
- Cash and Investments: Sangamo expects that its cash, cash equivalents and marketable securities will be at least
$150 million at the end of 2016, inclusive of research funding from existing collaborators but exclusive of funds arising from any additional new collaborations or partnerships, equity financings or other new sources. - Revenues: Sangamo expects that revenues will be in the range of
$20 million to$25 million in 2016, inclusive of research funding from existing collaborations. - Operating Expenses: Sangamo expects that operating expenses will be in the range of
$85 million to$95 million for 2016.
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