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AgeX Therapeutics and Lineage Cell Therapeutics Announce Expansion of Agreement Related to ESI Clinical-grade Pluripotent Stem Cell Lines for Therapeutic Purposes AgeX Secures Independence to License out ESI Cell

· 09/09/2020 08:29

AgeX Therapeutics and Lineage Cell Therapeutics Announce Expansion of Agreement Related to ESI Clinical-grade Pluripotent Stem Cell Lines for Therapeutic Purposes

  • AgeX Secures Independence to License out ESI Cell Lines as Part of its Collaboration and Licensing Model
  • Lineage Acquires Exclusivity for ESI Cell Lines in Spinal Cord Injury and Certain Oncology Indications

AgeX Therapeutics, Inc. (NYSE:AGE), a company focused on developing and commercializing innovative therapeutics for human aging, and Lineage Cell Therapeutics, Inc. ("Lineage": NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, and ES Cell International Pte Ltd. (ESI), a subsidiary of Lineage, today announced the broadening of their collaborative relationship with regard to ESI stem cell lines. ESI cell lines are current Good Manufacturing Practice (cGMP)-compatible, registered with the National Institutes of Health (NIH), and widely studied as a potential source for the industrial-scale manufacture of any cell type in the human body. Neither party made or received any cash payments in connection with this arrangement.

"Both Lineage and AgeX are pioneering important aspects of regenerative medicine. Working together, we have amended our agreement regarding ESI cell lines derived under cGMP to be optimal for the business needs of each company," stated Brian M. Culley, Lineage's CEO. "In particular, Lineage has acquired exclusivity for the use of ESI cell lines in spinal cord injury and certain oncology indications. On the other hand, AgeX has gained greater flexibility and independence to support its efforts toward licensing certain technologies and cell lines to third parties. With this step complete, we next intend to explore additional opportunities to collaborate with AgeX on promising tissue regenerating projects."

The ESI cell lines are recognized for being the first clinical-grade human pluripotent stem cell lines created under cGMP as described in the publication Cell Stem Cell (2007;1:490-4). It may become possible to generate potentially limitless quantities of all the cell types of the human body from these master cell banks with a wide array of potential therapeutic applications. These cell lines are listed on the NIH Stem Cell Registry and are among the best characterized and documented stem cell lines available globally. Importantly, ESI cells are among only a few pluripotent stem cell lines from which a derived cell therapy product candidate has been granted FDA investigational new drug (IND) clearance to commence human studies.

"Key to the creation of shareholder value is the placement of these important assets in the hands of collaborators to advance the development of a vast number of regenerative therapies," said Michael West, Ph.D., AgeX's CEO. "Our collaborative relationship with Lineage led to this streamlined process that may facilitate the commercialization of these applications to the benefit of shareholders of each company. Since the beginning of the year, AgeX has entered into new research and commercial arrangements utilizing an array of its technology platforms, such as UniverCyteTM for the engineering of universally transplantable cells, PureStem® for the manufacture and derivation of cells, and an ESI cell line as source material for deriving cellular therapeutics."

About AgeX Therapeutics, Inc

AgeX Therapeutics, Inc. (NYSE:AGE) is focused on developing and commercializing innovative therapeutics for human aging. Its PureStem® and UniverCyte™ manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeX's revolutionary longevity platform induced Tissue Regeneration (iTR™) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem® is AgeX's delivery technology to stably engraft PureStem cell therapies in the body. AgeX's core product pipeline is intended to extend human healthspan. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates. For more information, please visit www.agexinc.com or connect with the company on TwitterLinkedInFacebook, and YouTube.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

About ESI

ES Cell International Pte Ltd ("ESI"). Established in 2000, ESI, a wholly owned subsidiary of Lineage Cell Therapeutics, Inc., developed ESI hESC lines in compliance with the principles of current Good Manufacturing Practices and has made them available to various biopharmaceutical companies, universities and other research institutions, including AgeX. These ESI cell lines are extensively characterized and most of the lines have documented and publicly available genomic sequences.

Forward-Looking Statements for AgeX

Certain statements contained in this release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. 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. Without limitation, such risks include those associated with the use of human pluripotent stem cell lines in the research, development, and use of therapies for the treatment of human diseases, disorders, and injuries, and risks associated with commercializing the pluripotent stem cell lines. 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 AgeX Therapeutics, Inc. and its respective subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the "Risk Factors" section of its most recent Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. Undue reliance should not be placed on forward-looking statements, which speak only as of the date on which they were made. AgeX 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.

Forward-Looking Statements for Lineage

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential commercialization of ESI cell lines. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage's business and other risks in Lineage's filings with the Securities and Exchange Commission (the SEC). Lineage's forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage's periodic reports with the SEC, including Lineage's Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC's website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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