Ocata Therapeutics Receives SBIR Grant From The NIH’s National Eye Institute To Develop Proprietary Photoreceptor Progenitor Cell Therapy For Retinitis Pigmentosa

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Ocata Therapeutics, Inc. (NASDAQ:OCAT), a leader in the field of Regenerative Ophthalmology™, today announced that it has been awarded a Small Business Innovation Research (SBIR) grant from the National Eye Institute (NEI), part of the National Institutes of Health (NIH), to fund Investigational New Drug (IND)-enabling preclinical development of Ocata’s proprietary photoreceptor progenitor product for the treatment of retinal degenerative diseases, such as retinitis pigmentosa (RP) and photoreceptor dystrophies.

“Ocata has developed a unique and novel method for robust differentiation of human pluripotent stem cells into pure, renewable populations of retinal photoreceptor cells”

“Ocata has developed a unique and novel method for robust differentiation of human pluripotent stem cells into pure, renewable populations of retinal photoreceptor cells,” said Robert Lanza, M.D., Chief Scientific Officer at Ocata, and Principal Investigator of the grant. “Our studies in multiple animal models have shown that these cells can integrate into damaged retina, promote survival of host photoreceptors, and restore vision in completely blind animals, using either embryonic stem cells or induced pluripotent stem cells as source material.”

Retinal degenerative diseases are characterized by loss of photoreceptor cells resulting in permanent loss of vision and often blindness. Currently there is no curative therapy. These conditions exert extensive societal burdens on quality-of-life, productivity, and health-care costs, and thus an urgent need exists to develop strategies for retinal survival, repair, and replacement to combat RP and other degenerative diseases of the retina. The photoreceptor cell product developed by Ocata has been shown to have neuro-protective and restorative activity, in animal models, for both early and end stage retinal degenerative diseases.

“This second grant from the NIH, within weeks of our recently announced grant for the development of our HMC™ product to treat lupus, underscores our leadership in cell based therapy and recognizes the promise of our photoreceptor product as a potential new treatment for retinal degenerative diseases,” said Paul K. Wotton, President and CEO. “The depth and breadth of our pipeline provides a solid foundation to build a world class company based on innovative regenerative medicine technologies. Our goal is to aggressively develop our pipeline with the intent to file IND applications with the FDA as expeditiously as possible.”

About Ocata Therapeutics, Inc.

Ocata Therapeutics, Inc. is a clinical stage biotechnology company focused on the development and commercialization of regenerative ophthalmology therapeutics. Ocata’s most advanced products are in clinical trials for the treatment of Stargardt’s macular degeneration, dry age-related macular degeneration, and myopic macular degeneration. Ocata’s intellectual property portfolio includes pluripotent stem cell platforms – hESC and induced pluripotent stem cell (iPSC) – and other cell therapy research programs. For more information, visit www.ocata.com.

Forward-Looking Statements

All statements, other than historical facts, contained in this news release, including statements regarding Ocata’s belief regarding the continued development of its photoreceptor product, the ability to produce and the potential effectiveness of a pluripotent stem cell-derived product to treat retinal degenerative diseases, Ocata’s plans to develop its product pipeline and file IND applications and the expected timing of those activities, and any other statements about Ocata’s future expectations, beliefs, goals, plans, results or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: the fact that Ocata has no product revenue and no products approved for marketing; Ocata’s limited operating history; Ocata’s need for and limited sources of future capital; potential failures or delays in obtaining regulatory approval of products; risks inherent in the development and commercialization of potential products; reliance on new and unproven technology in the development of products; the need to protect Ocata’s intellectual property; the challenges associated with conducting and enrolling clinical trials; the risk that the results of clinical trials may not support Ocata’s product candidate claims; the risk that physicians and patients may not accept or use Ocata’s products, even if approved; Ocata’s reliance on third parties to conduct its clinical trials and to formulate and manufacture its product candidates; and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Ocata’s periodic reports, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2014. Forward-looking statements are based on the beliefs, opinions, and expectations of Ocata’s management at the time they are made, and Ocata does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of Ocata’s management at the time they are made, and Ocata does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that Ocata’s future clinical trials will be successful or that the results of previous clinical studies will lead to commercialization or products or therapies.