Cellular Biomedicine Group Reports First Quarter 2015 Financial Results And Provides Business Highlights
PALO ALTO, Calif., May 18, 2015 (GLOBE NEWSWIRE) -- Cellular Biomedicine Group, Inc. (Nasdaq:CBMG) ("CBMG" or the "Company"), a biomedicine firm engaged in the development of effective stem cell therapies for degenerative diseases and immunotherapies for cancer, reported financial results for the first quarter ended March 31, 2015 and provided business highlights.
"I am very pleased with the progress that we have made thus far in 2015," said Dr. William (Wei) Cao, Chief Executive Officer of Cellular Biomedicine Group. "Our lead regenerative medicine candidate, ReJoinTM human adipose-derived mesenchymal progenitor cell (haMPC) therapy for Knee Osteoarthritis (KOA) continues to make excellent progress, with positive interim clinical data from the Phase IIb trial confirming observations from the Phase IIa trial. The engagement of Huntsworth Health to build a global KOL advocacy campaign for the clinical trials of ReJoinTM will serve to analyze and broaden awareness of our clinical data. We expect to complete Phase IIb 12 month patient follow-up by the fourth quarter of 2015. We also announced positive Phase I clinical data from our Chimeric Antigen Receptor T-cell (CAR-T) immuno-oncology clinical development programs, CD19 for Acute Lymphocytic Leukemia (B-cell ALL) and CD20 for Advanced Diffuse Large B Cell Lymphoma (DLBCL) and will present our Phase I clinical data of CD30 for Hodgkin's lymphoma at the upcoming World Stem Cells & Regenerative Medicine Congress in London on May 21, 2015. We continue to strengthen our research and development capability with our international-standard GMP facility in Shanghai, which passed its 4th consecutive CFDA inspection, and expect to slate our third GMP facility in Beijing with the recently signed lease for a 15,000 square feet site. The recent addition of two new members to our Scientific Advisory Board will further fortify our Stem Cell and Immuno-Oncology platforms as we continue to position Cellular Biomedicine Group as a leader in both stem cell and cancer immune cell technologies in China."
"Thus far in 2015, we have achieved many business milestones and continue to deliver value to our shareholders," commented Tony (Bizuo) Liu, Chief Financial Officer of the Company. "Our upgrade to the NASDAQ Global Market validates the strong positive momentum around our cell therapy platforms and our strict adherence to corporate governance. The expansion of our GMP facilities to Beijing will allow us to prepare for any increases in demand from our two cellular platforms in the near future. We closed a private placement transaction of approximately $19.6 Million, which strengthens the Company's cash position which will enable the Company to execute on its clinical milestones and to build a world-class biotechnology firm focused on providing solutions that address large unmet medical needs."
First Quarter 2015 Financial Performance
1. Cash Position: Cash and cash equivalents as of March 31, 2015 were $31.1 million compared to $14.8 million as of December 31, 2014
2. Net Cash Used in Operating Activities: Net cash used in operating activities for the first quarter of 2015 was $2.41 million, compared to $2.38 million for the same period in 2014
3. Revenue: Revenues in the first quarter of 2015 were $603,390 compared to $61,051 for the same period in 2014. The revenue in first quarter 2015 is solely comprised of sales from the technical services related to Agreen's Tcm Immunotherapy service while revenue for the same period of 2014 is derived from the sales of the A-Stromal™ enzyme reagent kits. We expect our biomedicine business to generate revenues primarily from immune therapy and the development of therapies for the treatment of KOA in the next three to four years.
4. G&A Expenses: General and administrative expenses for the first quarter of 2015 were $3.5 million compared to $1.4 million for the same period in 2014. Increased expenses in 2015 were associated with increased corporate activities related to the management and development of our biomedicine business, including:
- An increase in stock-based compensation expense of $1.4 million, which primarily resulted from the new grants and higher fair value of unvested options after the Company listed on Nasdaq from June 2014 compared with those unvested options as of March 31, 2014;
- An increase in depreciation and amortization of $187,000, which was mainly attributed to the patents obtained from the acquisition of AG in the third quarter of 2014;
- An increase in payroll expenses of $166,000; and
- An increase in legal, accounting and other professional services of $211,000.
5. R&D Expenses: Research and development expenses for the first quarter of 2015 were $734,484, compared to $498,147 for the same period a year ago. The increase was primarily attributable to the increase of the Company's immunotherapy research and development team, which resulted in an increase in payroll expenses and an increase in rental expenses.
6. Net Loss: Net loss allocable to common stock holders was $4.3 million, compared to $446,531 for the same period in 2014. Changes in net loss are primarily attributable to changes in operations of the biomedicine segment and the discontinuation of the consulting segment.
Business Highlights of 2015 To Date
- Upgraded the listing of the Company's securities from the NASDAQ Capital Market to the NASDAQ Global Market
- Closed a private placement transaction under which it sold an aggregate of 515,789 shares of the Company's common stock to select private investors for total gross proceeds of approximately $19.6 million
- Acquired Chinese PLA General Hospital's Chimeric Antigen Receptor T cell (CAR-T) therapy, its recombinant expression vector CD19, CD20, CD30 and Human Epidermal Growth Factor Receptor's (EGFR or HER1) Immuno-Oncology patents (all pending), and Phase I/II clinical data of the aforementioned therapies and manufacturing knowledge
- Shanghai facility passed its 4th consecutive CFDA inspection, adhering to more than 1000 Standard Operating Procedures (SOPs) for operation and quality management
- Signed a lease for a 15,000 square feet site in Beijing slated for the Company's third GMP facility, with completion expected in Q3 2015
- Engaged Huntsworth Health, a global healthcare marketing and communications agency to build a global KOL advocacy campaign for the Company's ReJoinTM human adipose-derived mesenchymal progenitor cell (haMPC) clinical trials for the treatment of Knee Osteoarthritis
- Hosted "Advancing Solutions to Cancerous and Degenerative Straits" open house and tour at the Company's Shanghai GMP facility
- Appointed two members to the newly established Scientific Advisory Board to advise the Company on immuno-oncology and stem cell technology and its applications
Technology Achievements of 2015 To Date
- Released interim 24-week clinical data from the Phase IIb trial of the Company's ReJoinTM human adipose-derived mesenchymal progenitor cell (haMPC) therapy for Knee Osteoarthritis (KOA)
- Released clinical data from its CAR-T immuno-oncology clinical development programs, CD19 for Acute Lymphocytic Leukemia (B-cell ALL) and CD20 for Advanced Diffuse Large B Cell Lymphoma (DLBCL)
- Initiated patient recruitment to support a study of ReJoinTM human adipose derived mesenchymal progenitor cell (haMPC) therapy for Cartilage Damage (CD) resulting from osteoarthritis (OA) or sports injury
Upcoming Events
Management plans to participate in the following upcoming industry and investor conferences:
- May 20-22, 10th Annual World Stem Cells & Regenerative Medicine Congress, London, UK
- June 1-4, Jefferies 2015 Global Healthcare Conference, New York, USA
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 in China, 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.
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