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“In the past five months,
“An early accomplishment was to sell approximately half of our shares of AgeX, which we had created to develop BioTime’s preclinical regenerative medicine assets, to
“We next announced an exclusive collaboration with Orbit Biomedical for the use of Orbit’s proprietary injection technology to deliver our lead product candidate OpRegen®, for the treatment of dry age-related macular degeneration. The Orbit device delivers cells to the sub-retinal space via a suprachoroidal route as opposed to standard of care delivery directly through the retina. We are moving quickly to enroll our first patient in the Orbit portion of our ongoing Phase I/II study in the next quarter and we anticipate reporting additional clinical data from the study in the first half of this year.”
“We also intend to close our proposed acquisition of Asterias assuming approval by the respective shareholders of
“Finally, our affiliated company
“We are pleased with the continued progress at
Select Upcoming BioTime Events
- Special Meeting of BioTime Stockholders on
March 7, 2019at 9:30 am PTto vote on the proposed acquisition of Asterias. The closing is expected in Q1 2019 after the approval by the respective shareholders of Asterias and BioTime.
- Dosing of the first patient with the Orbit proprietary injection device in the ongoing Phase I/II clinical study of OpRegen® for the treatment of dry-AMD is planned for Q2 2019.
- Completion of patient enrollment in the ongoing Phase I/II clinical study of OpRegen® for the treatment of dry-AMD is anticipated in 2H 2019.
- Decision on BioTime’s CE Mark application for Renevia, an investigational medical device being developed as an alternative for whole adipose tissue transfer procedures, is dependent on European regulatory authorities.
BioTime is a clinical-stage biotechnology company focused on the development and commercialization of novel therapies for the treatment of degenerative diseases. BioTime’s pipeline is based on two platform technologies which encompass cell replacement and cell/drug delivery. BioTime’s lead cell replacement product candidate is OpRegen®, a retinal pigment epithelium transplant therapy in Phase 2 development for the treatment of dry age-related macular degeneration, the leading cause of blindness in the developed world. BioTime’s lead cell delivery clinical program is Renevia®, an investigational medical device being developed as an alternative for whole adipose tissue transfer procedures. 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 Twitter, LinkedIn,
Asterias is a biotechnology company dedicated to developing cell-based therapeutics to treat neurological conditions associated with demyelination and cellular immunotherapies to treat cancer. Asterias is presently focused on advancing three clinical-stage programs which have the potential to address areas of very high unmet medical need in the fields of neurology and oncology. OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. VAC2 (antigen-presenting allogeneic dendritic cells) is an allogeneic cancer immunotherapy. Asterias’ research partner, Cancer Research UK, has commenced a first-in-human clinical trial of VAC2 in non-small cell lung cancer. VAC1 (antigen-presenting autologous dendritic cells) is an autologous cancer immunotherapy with promising efficacy and safety data from an earlier Phase 2 study in Acute Myeloid Leukemia (AML). Asterias is also sponsoring pre-clinical work in two conditions with a demyelinating component: Multiple Sclerosis and White Matter Stroke, and is evaluating other cancer indications where its immunotherapy platform could provide therapeutic benefit. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.
AgeX 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 whole host 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 named 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 and slowly release iTR molecules in the body. AgeX is aggressively developing its core product pipeline for use in the clinic to extend human healthspan, and is seeking opportunities to form licensing and partnership agreements around its broad IP estate and proprietary technology platforms for non-core clinical applications. For more information on AgeX, please visit www.agexinc.com or connect with the company on Twitter,
Additional Information and Where to Find It
This communication is being made in respect of the proposed business combination involving
No Offer or Solicitation
This document does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Certain statements in this communication, including statements relating to the Merger Agreement, the Merger and the other transactions contemplated by the Merger Agreement, uncertainties as to the timing of the closing of Merger, including due to failure to satisfy or delay in satisfying the conditions to such closing; anticipated closing of
Solebury Trout IR