On May 6, 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 first quarter of 2020 (Press release, Cellular Biomedicine Group, MAY 6, 2020, View Source [SID1234557168]).

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"We currently have six clinical assets in development. In Q1, China’s National Medical Products Administration (NMPA) accepted our Investigational New Drug (IND) application for B-cell maturation antigen (BCMA) Chimeric antigen receptor (CAR) T-cell therapy for multiple myeloma (MM). Although early in the study, we are guardedly optimistic about the preliminary data of the 19 infused patients with only one patient being observed to have grade 3 cytokine release syndrome (CRS). We are excited to continue the development of this program and believe that our competitive advantages may be partially attributable to our proprietary manufacturing process with reduced vein-to-vein times. We are also conducting an Investigator-Initiated Trial (IIT) on our anti-CD19/CD20 BiCAR-T in non-Hodgkin’s lymphoma (NHL) in China and are seeing promising early data," said Tony (Bizuo) Liu, the Company’s Chief Executive Officer.

Mr. Liu added, "Together with our new Rockville, Maryland facility coming online in the latter part of the year, which will support the early phases of our U.S. clinical trials, and observation of the promising data in our China study, we are taking small steps to explore feasibility of a U.S. clinical trial for anti-CD19/CD20 BiCAR-T for non-Hodgkin’s lymphoma (NHL) as well as the tumor infiltrating lymphocytes (TIL) clinical trial for Non-Small-Cell Lung Cancer (NSCLC).

"Regarding our regenerative medicine program, with the COVID-19 outbreak tapering off in China, we have resumed patients’ enrollment for our knee osteoarthritis (KOA) Phase II allogenic (off the shelf AlloJoin) stem-cell clinical trial and are in the process of preparing for the Phase II autologous (ReJoin) trial as well.

"We are continuing to execute our vision to build a global platform of cutting-edge process development and incisive translational medicine, delivering innovative cell therapies to patients via personalized bespoke manufacturing processes. These transformative capabilities can bring not only fast vein-to-vein delivery but also safe and effective drugs to patients suffering with cancer and degenerative diseases. And amid the COVID-19 pandemic, we are pleased to have secured facilities to bolster our balance sheet to fund our clinical development."

First Quarter 2020 and Other Recent Corporate Developments

− Anti-BCMA CAR-T for Relapsed or Refractory Multiple Myeloma

• National Medical Products Administration of China (NMPA) accepted our IND application for Phase I clinical trial;

• 19 patients have been infused under investigator-initiated studies; 17 patients have evaluable data for clinical efficacy with only one grade 3 CRS observed;

− Anti-CD19/CD20 Bi-Specific CAR-T for Non-Hodgkin’s Lymphoma

• 4 patients have been infused under investigator-initiated studies; 3 patients have evaluable data for clinical efficacy;

− On April 30, 2020, we received approval for CNY 30 million line of credit (approximately USD $4.2 million).

First Quarter 2020 Financial Results

− Cash Position: Cash, cash equivalents and restricted cash of March 31, 2020 were $21.6 million, compared to $15.4 million as of December 31, 2019;

− Research & Development Expenses: R&D expenses were $7.8 million for the first quarter of 2020, compared to $6.0 million for the first quarter of 2019;

− General & Administrative Expenses: G&A expenses were $3.4 million for the first quarter of 2020, compared to $3.4 million for the first quarter of 2019;

− Net loss was $11.5 million for the first quarter of 2020, compared to $9.3 million for the first quarter of 2019;

− Executed a bridge loan of $16 million.