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

BitGo sikrer OCC-godkendelse til konvertering til føderalt chartret National Trust Bank13.12.2025 02:12:00 CET | Pressemeddelelse

Sætter ny standard for institutionel digital aktivinfrastruktur med samlet føderal tilsyn BitGo Holdings, Inc. (“BitGo”), virksomheden inden for digital aktivinfrastruktur, annoncerede i dag, at Office of the Comptroller of the Currency (“OCC”) godkendte virksomhedens ansøgning om at konvertere BitGo Trust Company, Inc., et trustselskab registreret i South Dakota, til en nationalbank ved navn BitGo Bank & Trust, National Association (N.A.). Med dagens OCC-godkendelse af konverteringen fungerer BitGos datterselskab af Trust Company nu som BitGo Bank & Trust, National Association (N.A.). BitGo Bank & Trust, N.A. vil operere under et enkelt, ensartet føderalt tilsynssystem, der gør det muligt at levere den klarhed, styring og reguleringssikkerhed, som institutioner forventer af et føderalt reguleret fiduciært selskab. Denne godkendelse styrker BitGos position som et institutionelt fundament for det moderne finansielle system, der kombinerer tilsyn på bankniveau med den sikkerhed, complian

FIA, Formula 1 Group and All 11 Race Teams Officially Sign the Ninth Concorde Agreement, Securing Strength and Stability for the Sport in Pivotal Five-Year Agreement12.12.2025 17:10:00 CET | Press release

Multi-year Concorde Governance Agreement signed by the FIA, Formula 1 Group and all 11 teams, securing the World Championship through 2030 Paves the way for a more professionalised sport and represents a new era of collaboration between the FIA and Formula 1 Group Long-term commitment enhances sporting reliability, global reach and stability for teams, fans and broadcasters The Fédération Internationale de l'Automobile (FIA), the global governing body for motor sport and the federation for mobility organisations worldwide, and Formula 1 Group, the Commercial Rights Holder, have today announced the signing of the Concorde Governance Agreement, a crucial contract defining the regulatory framework and governance terms of the FIA Formula One World Championship until 2030. This follows the announcement in March that the 2026 Commercial Concorde Agreement had been signed by all the teams and Formula 1 Group. Together, these agreements constitute the ninth Concorde Agreement, representing a m

Anabranch Capital Management, LP supports relisting of SmartCraft ASA to Nasdaq Stockholm12.12.2025 16:26:00 CET | Press release

Reference is made to the stock exchange announcement by SmartCraft ASA ("SmartCraft" or the "Company") on 1 December 2025 regarding the contemplated relisting of SmartCraft from Euronext Oslo Børs to Nasdaq Stockholm (the "Relisting") and the announcement of a cross-border merger to effect the Relisting. Funds managed by Anabranch Capital Management, LP (“Anabranch”) intend to vote in favour of the merger plan resolved by the boards of SmartCraft and its Swedish wholly owned subsidiary, SmartCraft Group AB (publ), to effect the Relisting at the Company's extraordinary general meeting planned for January 2025 (the "EGM"). Anabranch intends to vote with all Anabranch shares held at the Record Date for the EGM in favour of the relisting effected by the merger plan. Funds managed by Anabranch currently hold approximately 15.9 million shares in SmartCraft. Disclaimer: The views expressed are those of the authors and Anabranch Capital Management, LP as of the date referenced and are subject

Mohammed Ben Sulayem Re-Elected as President of the FIA12.12.2025 15:49:00 CET | Press release

The Fédération Internationale de l’Automobile (FIA), the global governing body for motor sport and the federation for mobility organisations worldwide, today confirms that Mohammed Ben Sulayem has been re-elected as President of the FIA, following the election of his Presidential List by the General Assembly in Tashkent, Republic of Uzbekistan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251212213181/en/ President Mohammed Ben Sulayem now begins his second four-year term, having overseen a period of significant renewal and stabilisation for the organisation since his initial election in 2021. Over the past four years, the FIA has undergone a wide-ranging transformation, improving governance, operations and restoring the financial health of the federation. These changes have strengthened the FIA’s position as the world’s governing body for motorsport and the leading authority on safe, sustainable, and affordable mobility.

Perma-Pipe International Holdings, Inc. Announces Third Quarter 2025 Financial Results12.12.2025 15:00:00 CET | Press release

Net sales of $61.1 million for the quarter and $155.8 million year-to-date.Income before income taxes of $10.9 million for the quarter and $21.1 million year-to-date.Diluted earnings per share of $0.77 for the quarter and $1.49 year-to-date.Backlog of $148.9 million at October 31, 2025, up from $138.1 million at January 31, 2025. Perma-Pipe International Holdings, Inc. (NASDAQ: PPIH) announced today financial results for the third quarter ended October 31, 2025. “For the three months ended October 31, 2025, net sales were $61.1 million, an increase of $19.5 million, or 46.9%, compared to $41.6 million in the same quarter of the prior year. Growth was driven by higher sales volumes in both the Middle East and North America. Gross profit was $21.0 million, up $6.9 million from $14.1 million last year, reflecting higher activity levels. Selling, general and administrative expenses increased to $8.3 million from $7.3 million, primarily due to higher payroll and professional fees, including

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