Company Will Advance Three Clinical Stage Product Candidates Addressing Significant Unmet Needs in Dry-AMD, Spinal Cord Injury, and Immuno-Oncology
ALAMEDA, Calif.--(BUSINESS WIRE)--Mar. 11, 2019-- BioTime, Inc. (NYSE American and TASE: BTX), today announced the closing of its previously reported acquisition of Asterias Biotherapeutics, Inc. (Asterias), whereby BioTime has acquired through a merger, all of the remaining outstanding common stock of Asterias which was not previously owned by BioTime. As a result of the acquisition, Asterias became a wholly-owned subsidiary of BioTime and the operations of BioTime and Asterias have combined. Notably, 98% of BioTime votes cast and 96% of Asterias votes cast were in favor of the merger. BioTime is now advancing three clinical stage product candidates for degenerative retinal diseases, neurological conditions associated with demyelination, and aiding the body in detecting and combating cancer. In connection with the closing, two members of the Asterias Board of Directors, Don Bailey, the former Chairman of Asterias’ Board and Michael Mulroy, the former Chief Executive Officer of Asterias will be serving on the BioTime Board of Directors. BioTime will continue to be led by the Company’s current management team.
“This acquisition is a key step in our plan to turn BioTime into a pioneering and leading cell therapy company, with an innovative and diversified pipeline which we believe can significantly impact disease areas with groundbreaking therapeutic approaches,” stated Brian M. Culley, Chief Executive Officer of BioTime. “Importantly, we expect to enjoy significant financial synergies from this merger as we already have a cGMP manufacturing facility in Jerusalem, Israel, which has successfully produced our projected needs for the next clinical trial of OpRegen® and which now can turn to process development and scale-up activities for the former Asterias assets. We also look forward to continuing our partnerships with notable institutions such as CIRM, the California Institute for Regenerative Medicine, and Cancer Research UK, to support the clinical development of the OPC1 and VAC2 programs we added to our pipeline. We further believe that greater involvement with patient and advocacy groups will be helpful toward increasing our value and visibility in the disease communities we aim to serve.”
BioTime’s Pipeline
- OpRegen® - a retinal pigment epithelium cell replacement therapy currently being tested in a Phase I/IIa multicenter clinical trial for the treatment of advanced dry-age-related macular degeneration (dry-AMD) with geographic atrophy. OpRegen® has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA).
- OPC1 - an oligodendrocyte progenitor cell therapy currently being tested in a Phase I/IIa multicenter clinical trial (the “SciStar Study”) for the treatment of acute spinal cord injuries (SCI). The clinical development of OPC1 has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of acute SCI and has been granted Orphan Drug Designation by the FDA.
- VAC2 - an allogeneic (non-patient-specific or “off-the-shelf”) cancer immunotherapy of antigen-presenting dendritic cells currently being tested in a Phase I clinical trial in non-small cell lung cancer (NSCLC) fully funded and conducted by Cancer Research UK, the world’s largest independent cancer research charity.
Following the closing of the merger, BioTime has 151,579,482 million shares of common stock issued and outstanding with prior BioTime stockholders collectively owning approximately 84% of the combined company, and prior Asterias stockholders collectively owning approximately 16% of the combined company.
BioTime’s financial advisor in the transaction was Maxim Group LLC. Raymond James acted as financial advisor to Asterias. Cooley LLP served as legal counsel to BioTime and Dentons LLP served as legal counsel to Asterias.
About BioTime, Inc.
BioTime is a clinical-stage biotechnology company developing new cellular therapies for degenerative retinal diseases, neurological conditions associated with demyelination, and aiding the body in detecting and combating cancer. BioTime’s programs are based on the Company’s proprietary cell-based therapy platform which is utilized to develop and manufacture specialized, terminally-differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed either to 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. BioTime has three cell therapy programs in clinical development. OpRegen® is a retinal pigment epithelium cell replacement therapy in Phase 2 development for the treatment of dry-AMD, the leading cause of blindness in the developed world. OPC1 is an oligodendrocyte progenitor cell therapy in Phase 2 development for the treatment of spinal cord injury. VAC2 is an allogeneic cancer immunotherapy in Phase 1 development for the treatment of non-small cell lung cancer (NSCLC) in partnership with Cancer Research UK, the world’s largest independent cancer research charity. For more information, please visit www.biotimeinc.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. 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. 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 (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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190311005200/en/
Source: BioTime, Inc.
BioTime Inc. IR
Ioana C. Hone
(ir@biotimeinc.com)
(510) 871-4188
Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@troutgroup.com)
(646) 378-2949