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AgeX Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update
ALAMEDA, Calif.--(BUSINESS WIRE)--August 14, 2020--AgeX Therapeutics, Inc. (“AgeX”; NYSE American: AGE), a biotechnology company developing therapeutics for human aging and regeneration, reported financial and operating results for the second quarter ended June 30, 2020.
AgeX made strides with respect to its newly established licensing and collaboration model, which aims to embed its technology platforms across the cell therapy industry. AgeX has entered into a research license for the use of its immunotolerance UniverCyteTM technology by Sernova Corp. (“Sernova”), a publicly-listed Canadian regenerative medicine therapeutics company. It also entered a Manufacturing, Marketing, and Distribution Agreement with Pluristyx, Inc. (“Pluristyx”), an advanced therapy tools and services company serving customers in the fields of regenerative medicine and cellular and gene therapies. In addition, AgeX signed a letter of intent with ImStem Biotechnology (“ImStem”), for ImStem to utilize AgeX’s ESI-brand pluripotent stem cells to derive a cell therapy product for potential use in the treatment of COVID-19 and as well acute respiratory distress syndrome (ARDS) from non-COVID-19 causes.
“We are working diligently to position our subsidiary Reverse Bioengineering to optimize the potential of induced tissue regeneration (iTR) technology,” said Michael West, CEO of AgeX. “We believe this technology offers a powerful new modality to treat age-related degenerative diseases by reversing developmental aging in a tissue, thereby unlocking an innate capacity of tissues to regenerate scarlessly.”
AgeX completed its restructuring to streamline its operations to allow efficient usage of capital in the current pandemic environment as well to meet near-term strategic company priorities of deriving value and generating preclinical and ultimately clinical data from our technology platforms through external licensing and collaboration agreements. In the longer-term, AgeX remains committed to in-house product development of AgeX-BAT1 and AgeX-VASC1. AgeX is considering options to bring capital into the company.
“AgeX has made excellent progress in terms of its collaboration and licensing model, closing five deals since the beginning of the year so far,” said Greg Bailey M.D., Chairman of AgeX. “The deals have spanned all three of our technology platforms of UniverCyte for the generation of universal cells, PureStem for the derivation and manufacturing of therapeutic cells, and AgeX ESI pluripotent stem cells to act as a source material for cellular therapies. All these deals show the value industry and academia see in our offerings.”
- AgeX entered into a research license with Sernova Corp. in which Sernova will utilize AgeX’s UniverCyteTM gene technology to generate immune-protected universal therapeutic cells for use in combination with Sernova’s Cell PouchTM for the treatment of type I diabetes and hemophilia A. The goal is to eliminate the need for immunosuppressive medications following cellular transplantation. Sernova has been granted a time-limited, non-exclusive research license by AgeX. A commercial license for Sernova to utilize UniverCyte for therapeutic and commercial purposes may be negotiated pending successful study outcomes. UniverCyte uses a proprietary, novel, modified form of HLA-G, a potent immunomodulatory molecule, which protects an unborn child from their mother’s immune system. In almost all human cells, native HLA-G expression is silenced after birth. AgeX’s modified HLA-G shows evidence of being resistant to this silencing, hence potentially allowing for long-term, stable and high expression. Sernova is a Canadian regenerative medicine therapeutics company.
- AgeX and ImStem Biotechnology, Inc. signed a non-binding letter of intent for ImStem to obtain from AgeX a non-exclusive license to use AgeX’s embryonic stem cell line ESI 053 to derive ImStem’s investigational mesenchymal stem cell (MSC) product IMS001 for development in COVID-19 as well as ARDS due to other causes. AgeX and ImStem are cooperating to finalize financial terms and other provisions of a license agreement. ImStem has previously used AgeX ESI 053 to derive its IMS001 product. Earlier this year, the U.S. Food and Drug Administration (FDA) cleared IMS001 to begin a Phase 1 clinical study in patients with multiple sclerosis. This is believed to be the first MSC product derived from human embryonic stem cells to be accepted for a clinical trial by the FDA. ImStem is a biopharmaceutical company developing human embryonic stem cell-derived mesenchymal stem cells.
- AgeX entered into a Manufacturing, Marketing and Distribution Agreement with Pluristyx, Inc. under which Pluristyx will perform certain services to manufacture, market and distribute on AgeX’s behalf, research-grade and clinical-grade AgeX ESI brand human pluripotent stem cells for therapeutic applications. This agreement allows industry and academia access to current Good Manufacturing Practice (cGMP)-grade, National Institutes of Health (NIH)-registered AgeX ESI cell lines. AgeX ESI cells are among only a few pluripotent stem cell lines from which derived cell therapy candidates have been granted FDA investigational new drug (IND) clearance to begin human trials. Academic and biopharma organizations will need to obtain separate commercial licenses from AgeX in order to advance their cellular product candidates generated from AgeX ESI cell lines into human clinical trials and commercialization. Pluristyx is an advanced therapy tools and services company serving customers in the fields of regenerative medicine and cellular and gene therapies.
The following information was filed by Agex Therapeutics, Inc. (AGE) on Friday, August 14, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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