Apr 25, 2013
CBMG Updates & Milestones
Cellular Biomedicine Group Provides Update and 2013 Milestones
PALO ALTO, Calif., April 25, 2013 /PRNewswire/ Cellular Biomedicine Group, Inc. (CBMG), a developer of proprietary cell therapies for the treatment of degenerative diseases and cancers, today announced companymilestones for 2013. In addition, yesterday the company filed an amendment to its Form 8-K regarding the merger between EastBridge Investment Corp. and Cellular Biomedicine Group Ltd., completed on February 6, 2013, in order to publicly announce historical financial information regarding CBMG.
“The first quarter of 2013 marked a critical period for CBMG,” said Dr.William Cao, President of Cellular Biomedicine Group. “We launched two Phase I/II clinical trials and the interim data has provided an encouraging signal for our company to move forward with further clinical development.”
2012 Financial Results
Combining the financial results of CBMG and EastBridge for the fiscal year ended December 31, 2012, these entities had combined revenue of $8.9 million, combined net income of$2.5million, and ended the year with a combined $4.9 million in cash, according to the unaudited pro forma financial statements furnished by the company. CBMG considered separately, had $0.27 million in revenue and a net loss of $5.59 million, for the year ending December 31, 2012.
2012 Achievements for Biomedicine Business
During 2012, the company reported the following progress for its biomedicine business:
· CBMG’sShanghai facility was awarded ISO-14644 cleanroom certification by ENV Inc.
· Shanghai and Wuxi facilities were accredited by the ISO (International Standards Organization) 9001:2008 certification by internationally recognized quality management system SGS
· Both CBMG Shanghai and Wuxi facilities became GMP-certified by an SFDA-certified institute
· CBMG Shanghai received Provisional Accreditation for its haMPC production and clinical application by the International Cellular Medicine Society of AABB
· The Wuxi Government designated CBMG Wuxi as the “Wuxi Stem Cell Technology Translation Center”
· CBMG President Dr.William Cao was elected as a member of the Expert Committee of the 3rdMedical Technology Approval Office, Chinese Medical Doctor Association, Ministry of Health, PRC
· CBMG President Dr. William Cao was appointed as a member of the Committee of International Cellular Medicine Society and American Association of Blood Banks for the Development of the Standards for the practice of Cell-Based Medicine.
Q1 2013 Clinical Trials
In the first quarter of 2013, the company initiated two clinical trials for two separate therapy candidates:
· haMPC (Human Adipose-derived Mesenchymal Progenitor Cells) therapy for Knee Osteoarthritis (KOA): www.clinicaltrials.gov #NCT01809769
· TC-DC Therapy for Hepatocellular Carcinoma (liver cancer): www.clinicaltrials.gov #NCT01828762
To date CBMG has 35 patents in various stages of filing and approval, including:
· 9 patents grantedin China
· 12 patents filed andpendingin China
· 9 in-licensed U.S.patents filed andpending
· 3 Patent Cooperation Treaty (PCT) patents filed andpending
· 2 patentapplications filed in China
The most recent patents granted in 2013 relate to the use ofallogeneic stromal vascular fraction or mesenchymal progenitor cells for the prevention,and treatment of Osteoarthritis and a patent for using allogeneic stromal vascular fraction and haMPCs or mesenchymal progenitor cells for the prevention and treatment of Rheumatoid Arthritis.
Key milestones that CBMG aims to accomplish in 2013 include:
· Approval of a Stromal Vascular Fraction (SVF) kitby the SFDA. SVF kits are ‘toolboxes’ used by physicians to safely extract cell samples from patients.
· Adipose tissue transportation kit approval as a medical device. These kits permit safe and effective transportation of extracted or processed cells.
· Completion of KOA Phase I trial safety data and advanced staggered filing of Phase IItrial.
· Preliminary HCC Phase I trial results.
· Approval of additional pendingPatent Cooperation Treaty (PCT) patents.
“We look forward to many new developments in 2013,” said Chairman and CEO Dr Steve Liu. “Not only are we the first company to pursue international compliance and set standards for two clinical pathways of cell therapies in China’s emerging cellular medicine market, but we have the advantage of operating manufacturing facilities at the highest international standards, and joint ventures with international partners. We believe we are poised to becomea leading translational cellular medicine platform in China, offering therapies to treat serious diseases prevalent in this region”.
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of certain degenerative diseases and cancers. Our developmental stem cell, progenitor cell, and immune cell projects are the result of research and development by scientists and doctors from China and the United States. Our flagship GMP facility, consisting of eight independent cell production lines, is designed, certified and managed according to U.S. standards. To learn more about CBMG, please visit:www.cellbiomedgroup.com.
Statements in this press release relating to plans, strategies, trends, specific activities or investments, and other statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include, but are not limited to, risk factors inherent in doing business. Forward-looking statements may be identified by terms such as "may," "will," "expects," "plans," "intends," "estimates," "potential," or "continue," or similar terms or the negative of these terms. Although CBMG believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. CBMG does not have any obligation to update these forward-looking statements other than as required by law.
Director of Corporate Communications, CBMG
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