Cellular Biomedicine Group Reports First Quarter 2018 Financial Results and Highlights Operational Progress
- China Food and Drug Administration Accepts the Company’s Investigational New Drug (IND) Applications for anti-CD19 CAR-T Therapy Targeting NHL and ALL
- Positive 48-Week Phase I Clinical Data of AlloJoinTMhaMPC therapy for KOA in China
- Ended quarter with $45.6 million in Cash
SHANGHAI, China and CUPERTINO, Calif., May 8, 2018 (GLOBE NEWSWIRE) — Cellular Biomedicine Group Inc. (NASDAQ: CBMG) (“CBMG” or the “Company”), a clinical-stage biopharmaceutical firm engaged in the development of immunotherapies for cancer and stem cell therapies for degenerative diseases, today reported financial results and business highlights for the first quarter ended March 31, 2018.
“Early in 2018, we’ve made notable progress with our immuno-oncology platform as the China Food and Drug Administration (CFDA) accepted the Company’s Investigational New Drug Applications (IND) for “C-CAR011” anti-CD19 chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult patients with B-cell Non-Hodgkin’s lymphoma (NHL) and acute lymphoblastic leukemia (ALL),” commented Tony Liu, Chief Executive Officer of CBMG. “We are advancing recognized CAR-T therapies through China’s regulatory pathway, with our state of the art GMP facility, which houses a CBMG-GE Healthcare China joint innovation center, and a CBMG-Thermo Fisher Scientific joint innovation center.
“The recent investment from Sailing Capital Overseas Investment Ltd., of $30.6 million, will enable further clinical development by funding our current multiple clinical programs, as well as expanding our immuno-oncology pipeline with further CAR-T receptor constructs for various liquid and solid tumor indications, including, but not limited to, Anti-BCMA CAR for multiple myeloma (MM). We continue to focus on accelerating deployment of new cell therapies to the clinical stage, confident in our in-house research and development capabilities, our CMC platform, and our broad clinical development network with leading medical institutions in China.”
Business & Technology Highlights of 2018 To Date
- SUBMITTED IND APPLICATION TO CFDA: In April 2018, the CFDA accepted the IND applications for “C-CAR011” anti-CD19 CAR-T therapy targeting NHL and ALL;
- PUBLISHED KOA DATA: In March 2018, 48-week clinical data from the Phase I clinical trial in China was presented for its allogeneic adipose-derived mesenchymal progenitor cell off-the-shelf therapy AlloJoinTMfor Knee Osteoarthritis (KOA), which demonstrated good safety and early efficacy for the prevention of cartilage deterioration;
- ENTERED INTO AGREEMENT WITH MEDICAL COLLEGE OF GEORGIA, AUGUSTA UNIVERSITY: In February 2018, CBMG, through its wholly-owned subsidiary, entered into an agreement with Augusta University to take a three-year option to license technology for T Cell Receptor (TCR), targeting Hepatocellular Carcinoma (HCC) (patent pending);
- COMPLETED PRIVATE EQUITY FINANCING: In February 2018, CBMG received a $30.6 million investment from Sailing Capital, a global private equity firm focused on disruptive technologies from innovative global companies in the healthcare, technology and consumer sectors;
- EXPANDED AGREEMENT WITH GE HEALTHCARE CHINA: In January 2018, CBMG and GE HEALTHCARE signed a plan to make CBMG the first company in the world to install GE HEALTHCARE FlexFactoryTM for cell therapy. CBMG will configure part of its facility in Shanghai with GE Healthcare’s FlexFactory™ platform to accelerate manufacturing timelines for its cell therapy clinical trials and commercial launches.
First Quarter 2018 Financial Performance
- Cash Position: Cash and cash equivalents as of March 31, 2018 were $45.6 million compared to $21.6 million as of December 31, 2017;
- Net Cash Used in Operating Activities: Net cash used in operating activities for the first quarter of 2018 was $5.6 million, compared to $4.9 million for the same period in 2017;
- G&A Expenses: General and administrative expenses for the first quarter of 2018 were $3.2 million compared to $3.2 million for the same period in 2017;
- R&D Expenses: Research and development expenses for the first quarter of 2018 were $5.3 million, compared to $3.0 million for the same period a year ago. The increase was primarily due to the pick-up in our development work and new talents recruited for anti-BCMA target for multiple myeloma, and other solid tumor indications at the Company’s newly operating state of the art GMP facility;
- Net Loss: Net loss allocable to common stock holders was $8.5 million, compared to $6.2 million for the same period in 2017.PR2018 Q1 report FINAL