On November 13, 2015 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 quarter ended September 30, 2015 and provided business highlights (Press release, Cellular Biomedicine Group, NOV 13, 2015, View Source [SID:1234508232]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Dr. William Wei Cao, Chief Executive Officer, commented, "We achieved pivotal milestones in the third quarter that redefined CBMG’s business and strategically positioned the Company as an emerging, bifurcated and world-class immuno-oncology and cell therapy contender with international aspirations through the advancement of key infrastructure and clinical milestones. We are encouraged by the positive clinical development of our therapeutic platforms in the third quarter. The Chinese PLA General Hospital ("PLAGH") CAR-T Phase I clinical trial for the treatment of patients with EGFR expressing advanced relapsed/refractory solid tumors in Non-Small Cell Lung Cancer ("NSCLC") and cholangiocarcinoma, and the Phase IIa CD20 Non-Hodgkin’s Lymphoma ("NHL") clinical trial have inspired us to accelerate their development to treat these terminal conditions. We are planning to launch multi-site CAR-T and Dendristim vaccine (previously called GVax) clinical trials in China and are evaluating options to further develop this prospective treatment in the U.S. In addition, we continued to strengthen our scientific team with the appointments of Alan List, M.D., as Chair of the Scientific Advisory Board and Yihong Yao, Ph.D., as Chief Scientific Officer."
"In terms of infrastructure, in addition to our Shanghai and Wuxi sites, we opened a new GMP facility in Beijing, and now operate three GMP facilities in China housing nine independent production lines to address increasing manufacturing demands."
"We believe we are one of the few emerging and versatile biotech companies with a growing revenue-generating T cell technical service. We have proven our ability to make acquisitions and expand globally recognized therapies addressing large and critical markets. We believe we are in an enviable position for the future in carrying out our mission to deliver evolutionary science and serving large patient populations," concluded Dr. William Wei Cao, Chief Executive Officer of Cellular Biomedicine Group.
Third Quarter 2015 Financial Performance
Cash Position: Cash and cash equivalents as of September 30, 2015 were $20.1 million compared to $14.8 million as of December 31, 2014
Net Cash Used in Operating Activities: Net cash used in operating activities for the third quarter of 2015 was $2.9 million, compared to $3.4 million for the same period in 2014
Revenue: Revenues in the third quarter of 2015 were $0.6 million compared to nil for the same period in 2014. All of the revenue has resulted from our acquisition of Agreen Biotech Ltd. that provides T cell technical services, and we are continuing to expand our network of hospitals to grow our revenue.
G&A Expenses: General and administrative expenses for the third quarter of 2015 were $3.5 million compared to $1.9 million for the same period in 2014. Increased expenses in 2015 were primarily attributed to the hiring of senior technical leaders, expanded GMP facility expenses, and amortization of the IP expenses associated with previous acquisitions.
R&D Expenses: Research and development expenses for the third quarter of 2015 were $2.2 million, compared to $0.8 million for the same period in 2014. Approximately two thirds of the increase resulted from the addition of scientific talent to our immunotherapy research and development team, while the remaining increase stems from increased clinical trial expenditures in CAR-T, Tcm, and automated production techniques.
Net Loss: Net loss allocable to common stock holders was $5.1 million, compared to $2.8 million for the same period in 2014. Changes in net loss are primarily attributable to an increase in share-based compensation and clinical trial expenses.
During and since the third quarter of 2015, Cellular Biomedicine Group achieved the following milestones and significant events:
Business Highlights
Appointed Alan List, M.D. as Chair of the Scientific Advisory Board
Appointed former MedImmune/AstraZeneca Director, Yihong Yao, Ph.D., B.S., as Chief Scientific Officer
Opened new GMP facility in Beijing
Evaluating options for U.S. clinical trials on NSCLC and Dendristim vaccine immune-cell therapy
Technology Achievements
Received two new certifications from the China Food and Drug Administration (the "CFDA") for its proprietary cell and tissue preservation media kits respectively, in accordance with the CFDA’s new regulations announced on June 1, 2015
Expanded our intellectual property portfolio from 70 to 77 patents in various stages of approval
Announced preliminary Phase I clinical results of CAR-T EGFR-HER1 ("CBM-EGFR.1") for the treatment of patients with EGFR expressing advanced relapsed/refractory solid tumors, with overall disease control rate (DCR) of 79% (19 of 24). 100% DCR in cholangiocarcinoma (5/5), 71% DCR in NSCLC (12/17)
Upcoming Public Events
Management is scheduled to participate in the following upcoming industry and investor conferences:
November 18-19, Jefferies 2015 Global Healthcare Conference, London, UK
December 1-2, Piper Jaffray Annual Healthcare Conference, New York, NY