0001157523-15-003779.txt : 20151110 0001157523-15-003779.hdr.sgml : 20151110 20151106075520 ACCESSION NUMBER: 0001157523-15-003779 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20151106 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20151106 DATE AS OF CHANGE: 20151106 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOTIME INC CENTRAL INDEX KEY: 0000876343 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 943127919 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-12830 FILM NUMBER: 151202460 BUSINESS ADDRESS: STREET 1: 1301 HARBOR BAY PARKWAY CITY: ALAMEDA STATE: CA ZIP: 94502 BUSINESS PHONE: 5105213390 MAIL ADDRESS: STREET 1: 1301 HARBOR BAY PARKWAY CITY: ALAMEDA STATE: CA ZIP: 94502 8-K 1 a51218957.htm BIOTIME, INC. 8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934


Date of Report (date of earliest event reported): November 6, 2015



BioTime, Inc.
(Exact name of registrant as specified in its charter)

California

1-12830

94-3127919

(State or other jurisdiction
of incorporation)

(Commission File Number)

(IRS Employer
Identification No.)


1301 Harbor Bay Parkway
Alameda, California 94502
(Address of principal executive offices)

(510) 521-3390
(Registrant's telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Forward-Looking Statements

Any statements that are not historical fact (including, but not limited to statements that contain words such as “may,” “will,” “believes,” “plans,” “intends,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements.  Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are contained in BioTime’s periodic reports filed with the SEC under the heading “Risk Factors” and other filings that BioTime may make with the Securities and Exchange Commission.  Undue reliance should not be placed on these forward-looking statements which speak only as of the date they are made, and the facts and assumptions underlying these statements may change.  Except as required by law, BioTime disclaims any intent or obligation to update these forward-looking statements.

This Report and any accompanying exhibits shall be deemed “furnished” and not “filed” under the Securities Exchange Act of 1934, as amended.

Section 7 - Regulation FD

Item 7.01 - Regulation FD Disclosure

On November 6, 2015, BioTime, Inc. issued the press release furnished as Exhibit 99.1, which is incorporated by reference.

Section 9 - Financial Statements and Exhibits

Item 9.01 - Financial Statements and Exhibits.

Exhibit Number

Description

99.1

Press release dated November 6, 2015



SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.



BIOTIME, INC.

 
 

Date:

November 6, 2015

By:

       /s/ Michael D. West

 

Chief Executive Officer

Exhibit Number

Description

99.1

Press release dated November 6, 2015

2

EX-99.1 2 a51218957ex99_1.htm EXHIBIT 99.1

Exhibit 99.1

BioTime, Inc. and Hepregen Corporation Form Ascendance Biotechnology, Inc. to Address the In Vitro Cell Biology Market

  • Combination of BioTime’s ESI BIO Division and Hepregen to Focus on Next-Generation Metabolism and Safety Screening of New Drugs and Chemicals
  • Provides Access to Hepregen’s Current Customer Base of Major Pharmaceutical and Chemical Companies
  • BioTime Retains Cell Therapy Opportunities While Gaining Entry to Drug Screening Industry

ALAMEDA, Calif. & MEDFORD, Mass.--(BUSINESS WIRE)--November 6, 2015--BioTime, Inc. (NYSE MKT and TASE: BTX), a clinical-stage regenerative medicine company, and Hepregen Corporation, a privately held company engaged in the development and marketing of proprietary drug screening products, today announced the formation of Ascendance Biotechnology, Inc. (“Ascendance”). Ascendance combines Hepregen’s application-directed, cellular micro-patterning drug and chemical screening technologies with BioTime’s ESI BIO research products and proprietary stem cell technologies. This asset combination will allow Ascendance to offer a broad portfolio of current and new stem-cell-derived assays and other products and services to Hepregen’s major pharmaceutical and chemical company customers.

Ascendance will continue to market Hepregen’s well-known HepatoPac® and HepatoMune® micro-patterned liver products, and plans to develop new and unique cell-based and micro-patterned products using BioTime’s stem cell technologies and broad intellectual property and product portfolio, including BioTime’s PureStem® embryonic progenitors and ESI embryonic stem cells. Ascendance expects that its first stem cell-based product will be targeted to important testing and assay applications in the pharmaceutical and chemical industries. Ascendance also expects to develop additional stem-cell-derived products that will be useful for toxicity testing in the cosmetic, environmental, and food industries.

Ascendance will be led by Hepregen’s Chief Executive Officer, Dr. Vincent R. Zurawski, Jr., a pioneer in the biotechnology industry, who was a co-founder of Centocor, Inc. Centocor was one of the first companies to commercialize monoclonal antibodies for diagnostic and therapeutic use, and was acquired by Johnson & Johnson in 1999 for more than $5 billion. Dr. Zurawski stated, “Ascendance will combine Hepregen’s proprietary technology and BioTime’s proprietary cell lines and technology to provide its clients in the pharmaceutical and chemical industries with an enhanced portfolio of next-generation, drug-development and safety-testing products and services comprised of both liver cells and additional cell types. Also, the combination of Hepregen and BioTime technologies may provide Ascendance with a potential path to the development of new drug products in collaboration with biopharma companies.”

According to Jeffrey Janus, previously President of BioTime’s ESI BIO division and now President of Ascendance, “The formation of Ascendance gives BioTime’s shareholders a two-fold benefit. It will provide BioTime’s cell-based products with a pathway to the pharmaceutical drug screening marketplace while providing a new source of revenues through the sale of the Hepregen line of assay products and new products slated for development by Ascendance. In addition, BioTime is retaining the rights to any cell-based therapeutic products generated by clinical researchers using BioTime’s stem cells and hydrogels.”


“Forming Ascendance as an independent company responsible for its own funding, and with its own sales and marketing capabilities, is aligned with our commitment to focus on therapeutics while allowing BioTime investors the opportunity to benefit from our extensive portfolio of technologies and intellectual property. Our ownership of part of Ascendance will allow our shareholders to benefit from the rapid growth of the large market for products used in drug efficacy screening and safety testing,” said Adi Mohanty, BioTime’s co-Chief Executive Officer.

Detailed financial terms of the transaction, and Hepregen’s historical revenue growth, are not being disclosed at this time. In exchange for its contribution of certain assets relating to its research products and related patents and technology, BioTime will acquire a majority equity position in Ascendance.

About BioTime

BioTime, Inc., a pioneer in regenerative medicine, is a clinical-stage biotechnology company. BioTime and its subsidiaries are leveraging their industry-leading experience in pluripotent stem cell technology and a broad intellectual property portfolio to facilitate the development and use of cell-based therapies and gene marker-based molecular diagnostics for major diseases and degenerative conditions for which there presently are no cures. The lead clinical programs of BioTime and its subsidiaries include OpRegen®, currently in a Phase I/IIa trial for the treatment of the dry form of age-related macular degeneration; AST-OPC1, currently in a Phase I/IIa trial for spinal cord injuries; Renevia™, currently in a pivotal trial in Europe as an injectable matrix for the engraftment of transplanted cells to treat HIV-related lipoatrophy; and cancer diagnostics, nearing the completion of initial clinical studies for the detection of lung, bladder, and breast cancers. AST-VAC2, a cancer vaccine, is in the pre-clinical trial stage.

BioTime’s subsidiaries include the publicly traded Asterias Biotherapeutics, Inc. (NYSE MKT: AST), developing pluripotent stem cell-based therapies in neurology and oncology, including AST-OPC1 and AST-VAC2; Cell Cure Neurosciences Ltd., developing stem cell-based therapies for retinal and neurological disorders, including OpRegen®; OncoCyte Corporation, developing cancer diagnostics; LifeMap Sciences, Inc., developing and marketing an integrated online database resource for biomedical and stem cell research; LifeMap Solutions, Inc., a subsidiary of LifeMap Sciences, developing mobile health (mHealth) products; ES Cell International Pte Ltd, which has developed cGMP-compliant human embryonic stem cell lines that are being marketed by BioTime for research purposes under the ESI BIO branding program; OrthoCyte Corporation, developing therapies to treat orthopedic disorders, diseases, and injuries; and ReCyte Therapeutics, Inc., developing therapies to treat a variety of cardiovascular and related ischemic disorders.

BioTime common stock is traded on the NYSE MKT and TASE under the symbol BTX. For more information, please visit www.biotimeinc.com or connect with the company on Twitter, LinkedIn, Facebook, YouTube, and Google+.


About Hepregen

Hepregen Corporation has been a leader in innovating unique and proprietary bioengineered micro-liver platforms for use in environmental testing, preventive care, and product development in the pharmaceutical and biopharmaceutical, diagnostic, cosmetics, and chemical industries. The company’s micro-liver HepatoPac® and HepatoMune® cell-based assays are intended to drive a paradigm shift in drug development. The utility of Hepregen’s human, rat, monkey, dog, and multi-species/multi-donor HepatoPac® and HepatoMune® application-directed products has been validated in collaboration with investigators at several well-known pharmaceutical companies. Hepregen was founded and initially capitalized by Battelle Ventures and Innovation Valley Partners with technology licensed from the Massachusetts Institute of Technology. The technology was developed by Professor Sangeeta Bhatia, a world renowned expert and leader in liver bioengineering for life science and therapeutic applications, and her associate, Dr. Salman Khetani.

Forward-Looking Statements

Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Ascendance Biotechnology, BioTime and its subsidiaries, 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 to be 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, 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 Ascendance and BioTime and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime’s Securities and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.

To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list: http://news.biotimeinc.com

CONTACT:
BioTime, Inc.
Dan L. Lawrence, 510-775-0510
dlawrence@biotimemail.com
or
Hepregen Corporation
Deborah Bender, 781-391-0205
dbender@hepregen.com
or
Ascendance
Stephanie Camacho
scamacho@biotimeinc.com
or
EVC Group, Inc.
Michael Polyviou, 646-445-4800
mpolyviou@evcgroup.com
or
Media Contact:
Gotham Communications, LLC
Bill Douglass, 646-504-0890
bill@gothamcomm.com
or
Israel Contact:
Gelbart-Kahana Investor Relations
Zeev Gelbart, +972-3-6074717
zeevg@gk-biz.com