On August 12, 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 its financial results and business highlights for the second quarter and six months ended June 30, 2020 (Press release, Cellular Biomedicine Group, AUG 12, 2020, View Source [SID1234563541]).
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"We held a virtual research & development day in July to provide an update on the six clinical programs we have in development," said Tony (Bizuo) Liu, Chief Executive Officer of CBMG. "Amid the global pandemic, we continue to enroll patients in investigator-initiated trials (IIT) for our clinical programs in China. This includes C-CAR088 anti-B-cell maturation antigen (BCMA) chimeric antigen receptor T cells (CAR-T) for relapsed or refractory multiple myeloma (MM), C-CAR039 anti-CD19/CD20 bi-specific CAR-T for Non-Hodgkin’s Lymphoma (NHL), and C-TCR055 alpha-fetoprotein (AFP) TCR-T in hepatocellular carcinoma (HCC). We look forward to the completion of our new Rockville facility later this year to support potential U.S. clinical development for C-CAR039 and C-TIL051 tumor-infiltrating lymphocytes (TIL) for non-small cell lung cancer (NSCLC). We also continue to enroll patients in China for our off-the-shelf AlloJoinTM knee osteoarthritis (KOA) Phase II trial. We plan to submit and present the C-CAR088 and C-CAR039 clinical data at a major conference later this year. We are happy to report that we have recently secured borrowings to support our near-term clinical development."
Clinical Highlights for First Half of 2020 and to Date:
C-CAR088 for MM*:
Infused 22 of the 25 enrolled patients; 17 patients with evaluable data for safety and clinical efficacy
No Grade 4 or higher cytokine release syndrome (CRS)
No Grade 2 or higher neurotoxicity and dose limiting toxicities
Cytopenia was mostly related to Cy/Flu lymphodepletion
17 patients with 100% best overall response; comprised of 5 complete response, 9 very good partial response and 3 partial response
C-CAR039 for NHL*:
Infused 10 of the 16 enrolled patients
No Grade 3 or higher CRS was observed
No Grade 2 or higher neurotoxicity
Cytopenia was mostly related to Cy/Flu lymphodepletion
Observed encouraging clinical efficacy with limited number of patients
C-TCR055 in HCC:
Initiated an early dose escalation study to evaluate the safety and efficacy
Conducted a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting: "Selecting Clinical Lead of TCRs Targeting Alpha-Fetoprotein-Positive Liver Cancer on Balance of Risk and Benefit"
On July 13, 2020, the Company hosted a virtual Research & Development Showcase to present an overview and update on the current state of its clinical and pre-clinical programs.
*: As of June 15, 2020
Business Highlights for First Half of 2020 and to Date:
Executed a one-year $25 million convertible bridge loan
Extended the $16 million convertible bridge loan repayment schedule to August, 2021
Obtained $8.6 million lines of credit
Upcoming Milestones:
In the next nine months, present our key clinical assets update at major conferences
In 2021, execute our C-TIL051 to sponsor and initiate an IIT in the U.S. for stage IIIB and IV NSCLC patients refractory to anti-PD1 immunotherapy
Upon completion, qualify our Rockville facility to support U.S. clinical development
Financial Results for the Second Quarter and First Half 2020 as compared to the same periods in 2019:
Net loss allocable to common stockholders for the quarter and six months ended June 30, 2020 was $13.5 million and $25.1 million respectively, compared to $12.1 million and $21.4 million
General and administrative expenses for the quarter and six months ended June 30, 2020 were $3.3 million and $6.7 million, respectively, compared to $3.2 million and $6.6 million
Research and development expenses for the quarter and six months ended June 30, 2020 were $10.1 million and $17.8 million respectively, compared $9.1 million and $15.0 million
Net cash used in operating activities for first half of 2020 was $19.8 million, compared to $18.8 million
Our cash, cash equivalents and restricted cash decreased to $13,581,952 at June 30, 2020 compared to $32,443,649 at December 31, 2019. Subsequent to end of the second quarter, we arranged additional borrowings of $29.3 million to fortify our balance sheet.