SANGAMO REPORTS NET LOSS OF $7.4 MIL FOR 2ND QTR 2008.Sangamo BioSciences, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :SGMO), Richmond, Calif., has reported second quarter 2008 financial results and accomplishments. For the second quarter ended June 30, 2008, Sangamo reported a consolidated net loss of $7.4 million, or $0.18 per share, compared to a net loss of $5.2 million, or $0.15 per share, for the same period in 2007. As of June 30, 2008, the company had cash, cash equivalents and investments of $64.3 million. Revenues for the second quarter of 2008 were $2.8 million, compared to $2.6 million for the second quarter of 2007. Second quarter 2008 revenues were primarily comprised of revenue recognition from the company's collaboration agreements with Dow AgroSciences (DAS) and Sigma-Aldrich, enabling technology agreements in protein production and research grants. The revenue recognized for the second quarter of 2008 consisted of $2.4 million in collaboration agreements and $464,000 in research grants. Research and development expenses were $8.3 million for the second quarter of 2008, compared to $6.3 million for the same period in 2007. The increase in research and development expenses for the second quarter of 2008 was primarily due to advancing the company's clinical development programs in diabetic neuropathy Diabetic Neuropathy Definition Diabetic neuropathy is a nerve disorder caused by diabetes mellitus. Diabetic neuropathy may be diffuse, affecting several parts of the body, or focal, affecting a specific nerve and part of the body. and pre-IND programs to develop ZFP ZFP Zone Forecast Product ZfP Zerstörungsfreie Prüfung (German: Non-Destructive Testing) ZFP Zuhair Fayez Partnership ZFP Zero-Flag Propagation Therapeutics for the treatment of HIV/AIDS HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome and glioblastoma glioblastoma /glio·blas·to·ma/ (gli?o-blas-to´mah) any malignant astrocytoma. glioblastoma multifor´me , as well as increased research and development personnel costs. Non-cash employee stock-based compensation included in research and development expenses totaled $0.7 million and $0.3 million in the second quarter of 2008 and 2007, respectively. General and administrative expenses were $2.5 million for the second quarter of 2008, compared to $2.1 million for the same period in 2007. The increase in general and administrative expenses was primarily due to increased personnel costs, including non-cash employee stock-based compensation which totaled $0.6 million in the second quarter of 2008 compared to $0.2 million in the same period in 2007. Total operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. for the second quarter of 2008 were $10.8 million, compared to $8.4 million for the same period in 2007. Net interest and other income was $570,000 for the second quarter of 2008, compared to $657,000 for the same period in 2007. Six Month Results For the six months ended June 30, 2008, the consolidated net loss was $15.4 million, or $0.38 per share, compared to a net loss of $10.5 million, or $0.30 per share, for the period ended June 30, 2007. Revenues were $5.6 million for the first half of 2008, compared to $4.0 million in the same period in 2007. Total operating expenses were $22.4 million for the first half of 2008 and $15.9 million in the first half of 2007. The increase in operating expenses for 2008 was primarily associated with Sangamo's clinical development programs in diabetic neuropathy and pre-IND programs to develop ZFP Therapeutics for the treatment of HIV/AIDS and glioblastoma, as well as increased research and development personnel costs and lab supply expenses. Recent Highlights -- Dow AgroSciences announces early exercise of commercial license for ZFP technology. Four months earlier than expected Dow AgroSciences (DAS) announced during the BIO International Convention in June that they had exercised their option, under and existing agreement with Sangamo, for a commercial license to Sangamo's zinc finger DNA-binding protein (ZFP) technology for use in plant agriculture. DAS will use the technology to generate products itself and plans to sublicense the technology to other companies under the trademark of ExZact Precision Traits(TM). As part of the agreement, Sangamo will receive a license fee payment of $6.0 million and the balance of the outstanding milestone payments of approximately $2.3 million. In addition, Sangamo is eligible to receive development and commercial milestone payments and royalties on product sales for any product that DAS develops, as well as 25% of any cash consideration received by DAS under such sublicenses. A webcast replay of the press conference that DAS hosted is available on Sangamo's website on the Investor page under Events and Presentations. -- Presentation of complete 180 day follow-up data from Phase 1b study of SB-509 in subjects with diabetic neuropathy (DN). Data from the Phase 1b clinical trial were presented at the American Diabetes Association The American Diabetes Association, or the ADA, is an American health organization providing diabetes research, information and advocacy. Founded in 1940, the American Diabetes Association conducts programs in all 50 states and the District of Columbia, reaching hundreds of Meeting in June. The data demonstrate statistically significant improvement in quantitative sensory testing and Neuropathy Impairment Score-Lower Limbs (NIS-LL), a quantitative measure of the neurologic exam Neurologic Exam Definition A neurological examination is an essential component of a comprehensive physical examination. It is a systematic examination that surveys the functioning of nerves delivering sensory information to the brain and caring motor , as well as clinically relevant trends toward improvement in nerve conduction nerve conduction n. The transmission of an impulse along a nerve fiber. Nerve conduction The speed and strength of a signal being transmitted by nerve cells. velocities. The trial was conducted in subjects with mild to moderate diabetic neuropathy over a six month period after a single administration of SB-509. SB-509 is an injectable formulation of plasmid DNA that encodes a ZFP transcription factor (ZFP TF(TM)), designed to upregulate the vascular endothelial endothelial /en·do·the·li·al/ (-the´le-al) pertaining to or made up of endothelium. Endothelial A layer of cells that lines the inside of certain body cavities, for example, blood vessels. growth factor-A (VEGF-A) gene. -- Phase 2 clinical trial phase 2 clinical trial Phase 2 study. See Phase study. , SB-509-701 fully enrolled and expanded. A Phase 2 study of SB-509 is being undertaken in subjects with moderate to severe diabetic neuropathy with at least one "blocked nerve". In addition to the announcement of the completion of accrual of the first part of the trial, Sangamo announced plans to expand and broaden the trial to test an additional dosing regimen. -- Data from critical limb ischemia Phase 1 trial presented at the International Society for Cellular Therapy Meeting. Sangamo's collaborators from Duke University presented data from the completed Phase 1 trial of the company's ZFP TF activator of VEGF-A for the treatment of critical limb ischemia. The data from this trial demonstrated that administration of the ZFP transcription factor resulted in a statistically significant increase in circulating stem cells stem cells, unspecialized human or animal cells that can produce mature specialized body cells and at the same time replicate themselves. Embryonic stem cells are derived from a blastocyst (the blastula typical of placental mammals; see embryo), which is very young in the peripheral blood peripheral blood Cardiology Blood circulating in the system/body . In addition, within a subgroup in which bone marrow cells were examined before and after treatment, the data suggests that subjects who showed the most marked clinical improvements, as judged by limb salvage limb salvage Orthopedics The returning of a limb to a state of reasonable functionality after severe trauma that might otherwise result in amputation. See Amputation. , ulcer healing, reduction in pain and increased oxygen concentrations in the tissues of the lower limbs, also showed the greatest increase in bone marrow stem cells. This observation of stem cell stem cell In living organisms, an undifferentiated cell that can produce other cells that eventually make up specialized tissues and organs. There are two major types of stem cells, embryonic and adult. mobilization after treatment with Sangamo's ZFP TF activator of VEGF-A, is being further investigated in an ongoing Phase 2 trial of SB-509, SB-509-703. -- Announcement of research and license agreement with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (Roche) for the use of ZFP technology to develop transgenic animals. In July, Sangamo and Sigma-Aldrich Corporation jointly announced a research and license agreement to provide Roche with non-exclusive, worldwide rights for the use of Sangamo's ZFP nuclease nuclease /nu·cle·ase/ (noo´kle-as) any of a group of enzymes that split nucleic acids into nucleotides and other products. nu·cle·ase n. (ZFN ZFN ZFP-Nuclease ZFN Zero order, Fixed corridor, Non-redundant Sample Transmission (TM)) technology to develop cell-lines and transgenic animals with targeted modifications in a specified gene in a specified species. Roche also has an option for an exclusive, worldwide license from Sangamo for the commercial use of such ZFN-generated transgenic animals in the production of therapeutic and diagnostic products. -- Publication of preclinical data in Nature Biotechnology. Papers highlighting therapeutic and research applications of Sangamo's ZFN technology were published in the scientific journal, Nature Biotechnology. The first paper demonstrated the use of ZFNs to efficiently generate transgenic animals, in this case zebrafish, a widely recognized system for human disease modeling and in vivo in vivo /in vi·vo/ (ve´vo) [L.] within the living body. in vi·vo adj. Within a living organism. in vivo adv. drug discovery. A second publication described the successful ZFN-mediated disruption of the CCR 1. CCR - condition code register. 2. CCR - (Database) concurrency control and recovery. 5 gene in human T-cells and the positive effects on HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. resistance and reduction in viral load in an animal model of HIV infection. About Sangamo Sangamo BioSciences, Inc. is focused on the research and development of novel DNA-binding proteins for therapeutic gene regulation and modification. The most advanced ZFP Therapeutic(TM) development program is currently in Phase 2 clinical trials for evaluation of safety and clinical effect in patients with diabetic neuropathy. Other therapeutic development programs are focused on stem cell mobilization, ALS Als (äls), Ger. Alsen, island, 121 sq mi (313 sq km), Sønderjylland co., S Denmark, in the Lille Bælt, separated from the mainland by the narrow Alensund. , cancer, HIV/AIDS, neuropathic pain, nerve regeneration, Parkinson's disease and monogenic diseases. Sangamo's core competencies enable the engineering of a class of DNA-binding proteins known as zinc finger DNA-binding proteins (ZFPs). By engineering ZFPs that recognize a specific DNA sequence Sangamo has created ZFP transcription factors (ZFP TF(TM)) that can control gene expression and, consequently, cell function. Sangamo is also developing sequence-specific ZFP Nucleases (ZFN(TM)) for gene modification. Sangamo has established strategic partnerships with companies outside of the human therapeutic space including Dow AgroSciences, Sigma-Aldrich Corporation and several companies applying its ZFP Technology to enhance the production of protein pharmaceuticals. For more information, visit http://www.sangamo.com. |
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