BioTime and Processa Announce Their Intention to Enter into a HyStem® Sublicense for Drug Delivery

  • Processa is led by a management team with a proven track record in drug development and drug delivery

ALAMEDA, Calif.--()--BioTime, Inc. (NYSE American: BTX), a late stage clinical biotechnology company focused on developing and commercializing products addressing degenerative diseases, today reached agreement on terms to sublicense certain HyStem® rights to Processa Pharmaceuticals, Inc. (“Processa”) for the creation of a sustained-release delivery platform.

“We are excited to form this new relationship with Processa. Dr. David Young and the team at Processa have a strong background in drug development, particularly with drug delivery platforms, and have been instrumental in more than 30 FDA approvals,” said Adi Mohanty, Co-Chief Executive Officer of BioTime. “This initiative will combine the expertise and experience of the Processa team with our HyStem platform, and together we hope to leverage the technology beyond the local delivery programs we are pursuing at BioTime. I believe that securing this potential sublicensing arrangement further validates and supports BioTime’s key strategic initiatives.”

“The Processa team and I are excited about accessing the HyStem technology platform as a way to address the numerous challenges that exist within drug delivery. This technology has the potential to be beneficial for many drugs. We are keen to make progress on the development of the HyStem platform for drug delivery,” said Dr. David Young, CEO of Processa. “I look forward to completing the agreement quickly and building a strong and long-lasting partnership with the BioTime team.”

About HyStem®

HyStem® is BioTime’s cell and drug delivery platform. HyStem® technology includes a family of unique, biocompatible hydrogels designed to effectively deliver cells or bioactive compositions for therapeutic benefit. HyStem® was designed to enable the effective transfer, engraftment and metabolic support for cells and is the basis of BioTime’s Renevia® program. The flexible chemistry of the HyStem® also allows for hydrogel optimization in the delivery of drugs and therapeutics. BioTime is actively pursuing local delivery aspects of this platform technology.

About BioTime, Inc.

BioTime is a late stage clinical biotechnology company focused on developing and commercializing products addressing degenerative diseases. The Company’s current clinical programs are targeting three primary sectors, aesthetics, ophthalmology and cell and drug delivery. Its clinical programs are based on two platform technologies: pluripotent cells, which can become any type of cell in the human body, and cell/drug delivery. Renevia®, a cell delivery product, met its primary endpoint in an EU pivotal clinical trial for the treatment of facial lipoatrophy in HIV patients earlier this year. Submission for approval of Renevia® is expected later this year, with an anticipated commercial launch in 2018. OpRegen®, a retinal pigment epithelium transplant therapy, is in a Phase I/IIa multicenter trial for the treatment of dry age-related macular degeneration, the leading cause of blindness in developing countries. BioTime also has significant equity holdings in two publicly traded companies, Asterias Biotherapeutics, Inc. (NYSE American: AST) and OncoCyte Corporation (NYSE American: OCX), and one 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+.

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About Processa Pharmaceuticals, Inc.

Processa Pharmaceuticals, Inc was founded with a mission to develop products that can improve the survival and/or quality of life for patients who have a high unmet medical need. The company has assembled a proven management team, Board of Directors and product development team. The Processa Team are experts in developing drug products from IND enabling studies to NDA submission. The company's combined scientific, development and regulatory experience has resulted in more than 30 drug approvals by the U.S. Food and Drug Administration (FDA) and more than 50 drug development programs, including drug products targeted to orphan disease conditions.

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 future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime, Inc. and its subsidiaries, the ability BioTime and its licensees to obtain additional FDA and foreign regulatory approval to market BioTime’s products, ability of the parties to reach a definitive agreement based on the term sheet, 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 in the results of clinical trials or regulatory approvals, need and ability to obtain future capital whether the parties can reach a definitive agreement based on the term sheet, 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 its 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.

Contacts

Investor Contact:
BioTime
David Nakasone, 510-871-4188
DNakasone@biotimeinc.com
Or
Media Contact:
JQA Partners, Inc.
Jules Abraham, 917-885-7378
jabraham@jqapartners.com

Contacts

Investor Contact:
BioTime
David Nakasone, 510-871-4188
DNakasone@biotimeinc.com
Or
Media Contact:
JQA Partners, Inc.
Jules Abraham, 917-885-7378
jabraham@jqapartners.com