On February 28, 2020 Cellular Biomedicine Group, Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, reported business highlights and financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Cellular Biomedicine Group, FEB 28, 2020, View Source [SID1234554994]).
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"We made significant progress in 2019 with four cancer immuno-cell therapy ("I/O") clinical studies and our allogeneic off-the-shelf, as well as autologous, stem cell assets on Knee Osteoarthritis ("KOA") clinical trials. We have also embarked on renovating a 22,000 square foot facility in Rockville to expand our research and development ("R&D") footprint in Maryland. Working with our partners, we have made substantial strides in our operation and further institutionalized our Shanghai manufacturing site," said Tony Liu, CEO of the company. "Because of our skills in tech transfer, process development and lean manufacturing, we are emboldened and plan to utilize our four cleanrooms at the Rockville site to support our U.S. clinical studies upon completion of the facility. This month we have also started to collaborate with Shanghai Ruijin Hospital on a pilot clinical study on inhalation of mesenchymal stem cell exosomes treating severe Novel Coronavirus Pneumonia ("NCP"). We are continuing to advance our I/O and KOA drug candidates both in China and the U.S."
Mr. Liu added, "Cell therapy has been embraced by both start-ups and large pharmas with the clear clinical benefits provided to patients globally. CBMG intends to leverage our internal capabilities, namely robust vein-to-vein integrated biopharma capabilities, as well as external collaboration, to rapidly bring these therapies to patients and help cure cancer.
"We are mindful of the ongoing risks posed by the coronavirus disease, or COVID-19. The full extent to which the coronavirus will negatively impact our business operations and results is still highly uncertain and cannot be accurately predicted; however, we have experienced, and expect to continue to experience, a slowdown in patient recruitment for our clinical studies."
2019 Clinical and Business Highlights
Initiated recruitment and showed early data for our Anti- B-cell maturation antigen ("BCMA") Chimeric antigen receptor T-cells ("CAR-T") for relapsed or refractory Multiple Myeloma ("r/r MM")
Began patient enrollment for our CD19/CD20 BiCar for Non-Hodgkins Lymphoma ("NHL")
Dosed first patient for our Alpha-Fetoprotein T-Cell Receptor ("AFP-TCR-T") technology targeting Hepatocellular Carcinoma ("HCC")
Began dosing patients for our Anti-CD20 CAR-T, targeting Anti-CD19 treated, relapsed Diffuse Large B-Cell Lymphoma ("DLBCL")
Received China National Medical Products Administration ("NMPA") Investigational New Drug application ("IND") acceptance to move to Phase II clinical trial for both off-the-shelf AlloJoin and ReJoin human adipose-derived mesenchymal progenitor cell ("haMPC") therapies for KOA
Expanding US footprint with new facility in Rockville, Maryland to support R&D and clinical studies
Fourth Quarter and Full Year 2019 Financial Results
Cash Position: Cash, cash equivalents and restricted cash as of December 31, 2019 were $32.4 million, compared to $52.8 million as of December 31, 2018
R&D Expenses: Research and development expenses were $37.7 million for 2019 as compared to $24.2 million for 2018
G&A Expenses: General and administrative expenses were $13.5 million for 2019 as compared to $13.2 million for 2018
Net Loss: Net loss was $50 million for 2019 as compared to $38.9 million for 2018