Business Wire

CA-BIOTIME,-INC.

Share
BioTime Announces $1.9 Million Grant for Continued Development of OpRegen® for Dry-AMD

BioTime, Inc. (NYSE American: BTX), a clinical-stage biotechnology company focused on degenerative diseases, has been awarded a new grant for 2018 of up to 6.9 million Israeli New Shekels (approximately $1.9 million) from the Israel Innovation Authority (the “IIA”). The grant provides funding for the continued development of OpRegen® , and to date the IIA has provided annual grants totaling over $13 million.

OpRegen® is currently in a Phase I/IIa clinical study, which in March 2018 received authorization from the Data Safety Monitoring Board (DSMB) to move forward with enrollment of cohort 4. The DSMB approval was based on the safety observed throughout the first three cohorts. Safety will remain the primary focus of cohort 4. The fourth cohort will include better vision patients than the previous three cohorts. These better vision patients will likely be in earlier stages of the disease and allow for a wide range of preliminary functional assessment measurements. These earlier stage patients will likely be the target patient population for this therapy and BioTime expects to share initial data from cohort 4 in the coming months.

“The IIA’s continued support is encouraging and shows their commitment and confidence in our ability to continue the development of OpRegen, our lead cell replacement program,” said Adi Mohanty, co-Chief Executive Officer of BioTime.

About OpRegen ®

OpRegen® , which is being studied for the treatment of the dry form of AMD, consists of a suspension of retinal pigment epithelial (RPE) cells that are delivered subretinally during a simple intraocular injection. RPE cells are essential components of the back lining of the retina, and function to help nourish the retina including photoreceptors. A proprietary process that drives the differentiation of human pluripotent stem cells is used to generate high purity OpRegen®  RPE cells. OpRegen®  RPE cells are also “xeno-free,” meaning that no animal products are used at any point in the derivation and production process. The avoidance of the use of animal products eliminates some potential safety concerns. Preclinical studies in rats have shown that following a single subretinal injection of OpRegen® , the cells can rapidly organize into its natural monolayer structure in the subretinal space and survive throughout the lifetime of the animal. OpRegen®  is designed to be an “off-the-shelf” allogeneic (non-patient specific) product. Unlike treatments that require multiple, frequent injections into the eye, it is expected that OpRegen®  will be administered in a single procedure. OpRegen®  was granted Fast Track designation from the FDA, which allows more frequent interactions with the agency, and eligibility for accelerated approval and priority review. OpRegen®  is a registered trademark of Cell Cure Neurosciences Ltd., a majority-owned subsidiary of BioTime, Inc.

About BioTime, Inc.

BioTime is a clinical-stage biotechnology company focused on degenerative diseases. Its clinical programs are based on two platform technologies: cell replacement and cell/drug delivery. With its cell replacement platform, BioTime is producing new cells and tissues with its proprietary pluripotent cell technologies. These cells and tissues are developed to replace those that are either rendered dysfunctional or lost due to degenerative diseases or injuries. BioTime’s cell/drug delivery programs are based upon its proprietary HyStem®  cell and drug delivery matrix technology. HyStem®  was designed, in part, to provide for the transfer, retention and/or engraftment of cellular replacement therapies. BioTime’s lead cell delivery clinical program is Renevia® , which consists of HyStem®  combined with the patient's own adipose (fat) progenitor cells. Renevia®  met its primary endpoint in an EU pivotal clinical trial for the treatment of facial lipoatrophy in HIV patients in 2017. BioTime has submitted Renevia®  for CE Mark approval in the EU. There were no device related serious adverse events reported to date. BioTime’s lead cell replacement product candidate is OpRegen® , a retinal pigment epithelium transplant therapy, which is in a Phase I/IIa multicenter clinical trial for the treatment of dry age-related macular degeneration, the leading cause of blindness in developing countries. There were no unexpected serious adverse events reported to date. BioTime also has significant equity holdings in two publicly traded companies, Asterias Biotherapeutics, Inc. (NYSE American: AST) and OncoCyte Corporation (NYSE American: OCX), and a private company, AgeX Therapeutics, Inc.

BioTime common stock is traded on the NYSE American and TASE under the symbol BTX. For more information, please visit www.biotime.com  or connect with the company on TwitterLinkedInFacebookYouTube , and Google+ .

To receive ongoing BioTime corporate communications, please click on the following link to join the Company’s email alert list: http://news.biotime.com .

Forward-Looking Statements

Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Statements pertaining to product technology, clinical development, regulatory approval timelines, the success of potential cosmetic applications and potential opportunities for BioTime, Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty as to the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the “Risk Factors” section of BioTime’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC (copies of which may be obtained at www.sec.gov ). Subsequent events and developments may cause these forward-looking statements to change. BioTime specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

Contact:

BioTime
David Nakasone, 510-871-4188
dnakasone@biotimeinc.com

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Murata Pushes Capacitor Design with World’s First 10µF/50Vdc MLCC in 0805-inch Size for Automotive Applications26.6.2025 04:00:00 CEST | Press release

Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) has announced the new GCM21BE71H106KE02 multilayer ceramic capacitor (MLCC) has entered mass production. The device is the world's first 0805-inch size (2.0 x 1.25 mm) MLCC to offer a capacitance of 10µF with a 50Vdc rating and is specifically engineered for automotive applications*. This cutting-edge product marks a significant advancement in MLCC design, delivering a smaller 0805-inch package while maintaining capacitance, voltage rating, and MLCC reliability. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250611043543/en/ [Murata Manufacturing Co., Ltd.] 10µF/50Vdc MLCC in 0805-inch Size for Automotive Applications Advancements in advanced driver-assistance systems (ADAS) and autonomous driving (AD) technologies necessitate deploying an increased number of integrated circuits (ICs) within vehicle systems. This surge in ICs simultaneously leads to a greater

Mars’ Pending Acquisition of Kellanova Clears FTC Antitrust Review26.6.2025 02:07:00 CEST | Press release

Mars, Incorporated, a family-owned, global leader in pet care, snacking and food, and Kellanova (NYSE: K), a leader in global snacking, international cereal and noodles and North America frozen foods, today announced that the U.S. Federal Trade Commission (FTC) has concluded its antitrust review of Mars’ pending acquisition of Kellanova. Poul Weihrauch,CEO & Office of the President, Mars, Incorporated, said: “We are very pleased that the FTC has completed its review of the transaction without the imposition of any condition or requiring any remedy. The transaction has now received all but one of the 28 required regulatory clearances, with only the review by the European Commission outstanding. This brings us one step closer to uniting two iconic businesses with complementary footprints and portfolios, allowing us to deliver more choice and innovation to consumers.” Steve Cahillane, Chairman, President & CEO, Kellanova, said: “This represents a significant milestone on our path to combi

VeriSilicon Expands DSP Portfolio with Silicon-Proven ZSP5000 Vision Core Seriesfor Edge Intelligence26.6.2025 02:00:00 CEST | Press release

Highly scalable architectureoptimized for computer vision and image workloads with extendable instruction set VeriSilicon (688521.SH) today released the ZSP5000 Digital Signal Processing (DSP) series IPs, which are based on its fifth-generation silicon-proven DSP architecture. This product line adopts a highly scalable and energy-efficient design, and has been deeply optimized for compute-intensive workloads such as computer vision and embedded AI. Combined with the configurable nature of the architecture, this series of IP can provide excellent solutions with both energy and computing efficiency for various edge devices. The ZSP5000 series IPs include ZSP5000, ZSP5000UL, ZSP5000L, and ZSP5000H, delivering scalable vector processing performance ranging from 32 to 256 8-bit Multiply-Accumulate (MAC) operations per cycle. For even higher performance, VeriSilicon’s multi-core ZSP5400H can combine multiple ZSP5000H cores in a multi-cluster architecture to further scale computing capability

Newpark Fluids Systems Strengthens Executive Leadership and Board to Drive Continued Growth25.6.2025 21:39:00 CEST | Press release

Newpark Fluids Systems (“Newpark” or the “Company”), a leading global independent provider of drilling and completion fluids solutions, and SCF Partners (“SCF”) are pleased to announce several key additions to the Company’s executive leadership and Board of Directors. These strategic appointments, along with significant capital investments, including the development of a leading liquid mud facility in West Texas and a new technology center of excellence in Saudi Arabia, underscore Newpark’s commitment to operational excellence, customer value, and accelerated global growth following its acquisition in 2024. Nathan Snoke has joined Newpark Fluids Systems as Senior Vice President, Western Hemisphere bringing nearly two decades of predominantly North American oilfield experience to his role, most recently holding operational and commercial leadership positions with Halliburton and Flotek. He has worked across every major U.S. shale play—from the Rockies and Permian to the Marcellus and Ha

Intelsat Partners with Whitaker Peace & Development Initiative to Expand Access to Education in East Africa25.6.2025 21:00:00 CEST | Press release

Satellite-powered connectivity will support enhanced online education in conflict-affected regions in South Sudan and Uganda Intelsat, operator of one of the world’s largest integrated satellite and terrestrial networks, announced today a groundbreaking partnership with Academy Award-winning actor and humanitarian Forest Whitaker’s nonprofit, the Whitaker Peace & Development Initiative (WPDI), to revolutionize access to education in conflict-affected regions across Africa. The collaboration will deliver for the first time high-speed internet connectivity to WPDI’s Community Learning Centers in South Sudan and Uganda, creating digital bridges to education for thousands of young people in areas where infrastructure has been insufficient or compromised. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250625237871/en/ This unprecedented effort will bring reliable internet access to communities where traditional connectivity infra

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye