-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, JRriTfApkYOWQomtXPCii2Ghq1o5PrPqJH5ZpTrYTJcSx23OU89xjK4n+vgo243n cZNB2QA1TshOiXMT5GJblw== 0001157523-11-000808.txt : 20110214 0001157523-11-000808.hdr.sgml : 20110214 20110214091955 ACCESSION NUMBER: 0001157523-11-000808 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20110211 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20110214 DATE AS OF CHANGE: 20110214 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: 11602426 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 a6609772.htm BIOTIME INC. 8-K

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): February 11, 2011




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))


Statements made in this Report that are not historical facts may constitute forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those discussed.  Such risks and uncertainties include but are not limited to those discussed in this report and in BioTime's other reports filed with the Securities and Exchange Commission. Words such as “expects,” “may,” “will,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” and similar expressions identify forward-looking statements.

Section 1 - Registrant’s Business and Operations

Item 1.01 Entry into a Material Definitive Agreement.

          On February 11, 2011, we and our subsidiary OrthoCyte Corporation (“OrthoCyte”) entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Glycosan BioSytems, Inc. (“Glycosan”) pursuant to which Glycosan agreed to merge with OrthoCyte.  Through the merger, Glycosan stockholders will receive, in the aggregate, approximately 332,906 BioTime common shares, and warrants to purchase approximately an additional 206,612 BioTime common shares at an exercise price of $10 per share (the “Warrants”).  The Warrants will expire on May 3, 2014.

          Established in 2006, Glycosan has been a leader in developing, manufacturing, and marketing proprietary biocompatible hydrogels that mimic the extracellular matrix (ECM). The ECM is an important and complex mixture of macromolecules that holds cells together in tissues and organs and performs many other important functions. Glycosan’s products have the demonstrated ability to support the growth and directed differentiation of stem cells and are designed as implantable, resorbable matrices for tissue engineering, regenerative medicine, and for research applications involving the laboratory culture of human cells. BioTime expects to utilize the technology in its future stem cell-based therapeutic products and to continue the marketing of the products for research use.

          Glycosan’s technology was invented by Glenn D. Prestwich, Ph.D. (Presidential Professor of Medicinal Chemistry at the University of Utah) and was assigned to the University of Utah.  Glycosan holds a license from the University to use the patents to that technology outside the United States in 27 member states of the European Union, Canada, Australia, and Japan exclusively for all uses except veterinary use, and within the United States exclusively for cosmetics, reagents and platforms for in vitro cell and tissue culture, platforms and services for in vitro drug toxicology and efficacy testing, in materials for preserving or extending the useful life of human organs and tissues, and for in vivo xenograft models using human tissues.  Also within the U.S., the licensed fields of use include the co-exclusive use of the patent rights to make, use, and sell products and methods in which living tissue or cells are incorporated outside the body into a polymer platform, at a facility other than the “point-of-care” facility, for subsequent implant in patients for therapeutic use.

2

Glycosan manufactures Extracel, PEGgel, and HyStem hydrogel products for basic laboratory research use, and sells those products directly and through arrangements with distributors in the United States and abroad.  Glycosan has recently completed pre-clinical development of HyStem-Rx for potential use as an implantable cell delivery matrix.  The formulations and performance of Glycosan’s Extracel, Hystem, and HyStem-Rx hydrogels are identical, but HyStem-Rx is manufactured and tested to be a much higher level of purity.  The use of HyStem-Rx as an implantable cell delivery matrix in humans will require approval by the United States Food and Drug Administration and comparable regulatory agencies in foreign countries, which have not yet been obtained.  Approval of the device for human therapeutic use might also create an expanded market for the device to other developers of therapeutic tissue transplant products.

           OrthoCyte was formed in 2010 to develop cell-based therapies for the treatment of orthopedic diseases and injuries. OrthoCyte has compiled proprietary animal preclinical data on two therapeutic product candidates designated OTX-CP03 and OTX-CP07, which were formulated in Glycosan’s hydrogel and showed initial evidence of safety and efficacy in animal models of joint disease.

          Dr. William P. Tew, Ph.D., Glycosan’s co-founder, President and Chief Executive Officer, will become the Vice President of Business Development of OrthoCyte following the merger. Dr. Tew has extensive experience in life sciences, biopharmaceuticals, and university technology licensing. He was on the research and teaching faculty at Johns Hopkins University School of Medicine from 1979-1983, and served as Associate Provost and Assistant Dean of Technology Licensing from 2000-2004. In 1980 he founded Chesapeake Biological Laboratories, where he served as chairman and CEO for almost two decades (1981-1999), developing and manufacturing bulk pharmaceuticals, parenteral drugs, and medical devices in compliance with FDA and cGMP regulations. He also oversaw the design, validation, and operation of sterile filling and packing facilities and implemented reliable ISO quality-management systems.

          We expect that the merger will be completed on or about March 18, 2011.  The obligations of BioTime, OrthoCyte, and Glycosan to consummate the merger is subject to the satisfaction of certain conditions, including approval of the merger by the Glycosan stockholders, and that the BioTime shares to be issued in the merger and upon exercise of the Warrants are approved for listing on a when issued basis by the NYSE Amex.

          Ten percent of the BioTime common shares and Warrants issued in the merger will be held in escrow for six months, subject to extension in the case of any pending claims, from which BioTime and OrthoCyte are entitled to be indemnified under the Merger Agreement.  If any indemnified claims arise during the escrow period, an amount of shares and warrants having a value equal to the amount of the indemnified claim will be returned to us for cancellation in satisfaction or partial satisfaction of the indemnified claim.

3

          We have agreed to register the BioTime shares and Warrants issued in the merger, and the BioTime shares issuable upon exercise of the Warrants, for sale under the Securities Act of 1933, as amended, for the account of the former Glycosan stockholders.  We will bear the costs and expenses of such registration, including all costs related to the preparation and filing of a registration statement, and the printing of prospectuses.  We will also indemnify the former Glycosan stockholders from certain liabilities that may arise under the Securities Act.

Section 9-Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits.

Exhibit Number

Description

 
99.1 Press Release Dated February 14, 2011

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: February 14, 2011

By:  

/s/ Robert W. Peabody

 

Robert W. Peabody,
Senior Vice President,
Chief Operating Officer and

Chief Financial Officer

4

Exhibit Number

Description

 

99.1

Press Release Dated February 14, 2011



5

EX-99.1 2 a6609772_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

BioTime Announces Agreement To Acquire Glycosan BioSystems

Acquisition to accelerate BioTime’s development of tissue engineered therapeutic products and expand research product portfolio

ALAMEDA, Calif.--(BUSINESS WIRE)--February 14, 2011--BioTime, Inc. (NYSE Amex:BTX), a biotechnology company that develops and markets products in the field of stem cells and regenerative medicine, today announced it has signed a definitive agreement to merge Utah-based Glycosan BioSystems, Inc. (Glycosan) with BioTime’s wholly-owned subsidiary, OrthoCyte Corporation. The acquisition is expected to close by March 18, 2011.

Established in 2006, Glycosan has been a leader in developing, manufacturing, and marketing proprietary biocompatible hydrogels that mimic the extracellular matrix (ECM). The ECM is an important and complex mixture of macromolecules that holds cells together in tissues and organs and performs many other important functions. Glycosan’s products have the demonstrated ability to support the growth and directed differentiation of stem cells and are designed as implantable, resorbable matrices for tissue engineering, regenerative medicine, and for research applications involving the laboratory culture of human cells. BioTime expects to utilize the technology in some future stem cell-based therapeutic products and to continue the marketing of the products for research use only.

As a result of the merger, Glycosan stockholders will receive total consideration, in the aggregate, of approximately 332,906 BioTime common shares, and warrants to purchase approximately 206,612 additional BioTime common shares at an exercise price of $10 per share. OrthoCyte will subsequently own all of Glycosan's assets, including manufacturing equipment, inventory, and technology licenses, and will assume Glycosan’s obligations, which at January 31, 2011 totaled approximately $218,000.


“The founding scientists of Glycosan have been pioneers in the field of tissue engineering,” said Michael D. West, Ph.D., President and Chief Executive Officer of BioTime, Inc. “The inventions of Dr. Glenn Prestwich, Presidential Professor of Medicinal Chemistry at the University of Utah combined with BioTime’s stem cell technologies, give BioTime and its subsidiaries a broad manufacturing platform. Our subsidiary OrthoCyte plans to utilize this combination in the development of the therapeutic products OTX-CP03 and OTX-CP07, targeted for use in the treatment of osteoarthritis.”

“By joining forces with BioTime and OrthoCyte, we hope to advance the development of technology and tissue-engineered therapeutic products,” said William P. Tew, Ph.D., President and CEO of Glycosan BioSystems, Inc. “Researchers have already used our hydrogel products in animal models studying osteoarthritis, a disease that affects over 20 million people in the U.S. We look forward to continue contributing to these studies and more as part of the BioTime family of companies.”

Background

Regenerative medicine refers to the development and use of therapies based on human embryonic stem (hES) cell or induced pluripotent stem (iPS) cell technology. The great scientific and public interest in regenerative medicine lies in the potential of hES and iPS cells to become all of the cell types of the human body. Many scientists therefore believe that hES and iPS cells have considerable potential as sources of new therapies for a host of currently incurable diseases such as diabetes, Parkinson’s disease, heart failure, arthritis, muscular dystrophy, spinal cord injury, macular degeneration, hearing loss, liver failure, and many other disorders where cells and tissues become dysfunctional and need to be replaced.

Historically speaking, the complexity of cell types obtainable from hES and iPS cells has also been a challenge. Human therapeutic products require a high degree of purity to meet the hurdles of regulatory approval. BioTime’s ACTCellerate™ technology was invented as a means of generating over 140 diverse human cell types from hES or iPS cells in a scalable and highly purified state. These diverse cell lines have applications in basic laboratory research and are being marketed for that purpose. In addition, many of the ACTCellerate cell lines may have important human therapeutic applications. Some of these therapeutic applications will require the reconstitution of cells with ECM to create the architecture of a tissue, a field known as tissue engineering.


OrthoCyte was formed in 2010 to develop cell-based therapies for the treatment of orthopedic diseases and injuries. OrthoCyte has compiled proprietary animal preclinical data on two therapeutic product candidates designated OTX-CP03 and OTX-CP07, which are tissue engineered products, formulated in Glycosan’s hydrogel, and they show initial evidence of safety and efficacy in animal models of joint disease.

Dr. William P. Tew, Ph.D., Glycosan’s co-founder, President and Chief Executive Officer, will become the Vice President of Business Development of OrthoCyte and is expected to become Vice President of Business Development of BioTime following the closing of the merger. Dr. Tew has extensive experience in life sciences, biopharmaceuticals, and university technology licensing. He was on the research and teaching faculty at Johns Hopkins University School of Medicine from 1979-1983, and served as Associate Provost and Assistant Dean of Technology Licensing from 2000-2004. In 1980 he founded Chesapeake Biological Laboratories, where he served as chairman and CEO for almost two decades (1981-1999), developing and manufacturing bulk pharmaceuticals, parenteral drugs, and medical devices in compliance with FDA and cGMP regulations. He also oversaw the design, validation, and operation of sterile filling and packing facilities and implemented reliable ISO quality-management systems.

For more information on OrthoCyte, please visit our website at www.orthocyte.com.

About BioTime, Inc.

BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is developed through subsidiaries focused on specific fields of applications. BioTime develops and markets research products in the field of stem cells and regenerative medicine, including a wide array of proprietary ACTCellerate cell lines, culture media, and differentiation kits. BioTime's wholly owned subsidiary ES Cell International (ESI) has produced clinical-grade human embryonic stem cell lines that were derived following principles of Good Manufacturing Practice and currently offers them for use in research.


BioTime's therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime's majority owned subsidiary Cell Cure Neurosciences, Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. Cell Cure's minority shareholder Teva Pharmaceutical Industries has an option to clinically develop and commercialize Cell Cure's OpRegen™ retinal cell product for use in the treatment of age-related macular degeneration (AMD). BioTime's subsidiary OrthoCyte Corporation is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the therapeutic applications of stem cell technology in cancer. ReCyte Therapeutics is developing applications of BioTime's proprietary iPS cell technology to reverse the developmental aging of human cells for cardiovascular and blood cell aging. In addition to its stem cell products, BioTime develops blood plasma volume expanders, blood replacement solutions for hypothermic (low temperature) surgery, and technology for use in surgery, emergency trauma treatment and other applications. BioTime's lead product, Hextend®, is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corp. under exclusive licensing agreements. Additional information about BioTime, ReCyte Therapeutics, Cell Cure, OrthoCyte, OncoCyte, BioTime Asia, and ESI can be found on the web at www.biotimeinc.com.

Forward-Looking Statements

Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for the company 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 company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company 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://www.b2i.us/irpass.asp?BzID=1152&to=ea&s=0

CONTACT:
BioTime, Inc.
Judith Segall, 510-521-3390 ext. 301
jsegall@biotimemail.com

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