Zhou summed up Cellular Biomedicine Group Inc.'s (CBMG:NASDAQ) recent activities in an Aug. 9 research report. "CBMG's cell therapy programs continue to make progress," she wrote. "We expect to see data from both the CARD-1 and CALL-1 chimeric antigen receptor T-cell (CAR-T) studies by 2017E, setting the stage for a value inflection as CBMG becomes a Phase 2 CAR-T player."
The analyst also noted the company has enough cash to get to that stage. "CBMG ended the period with $27M in cash," Zhou noted. "At the current burn rate, we estimate CBMG has sufficient capital to fund through topline data releases (by 2017E) from its CARD-1 and CALL-1 studies, which should represent catalysts for the stock."
She reiterated what the company's two China-based Phase 1 studies consist of:
1. Initiated in Q1/17, CALL-1 is a "dose-escalation study (n=9) that uses the optimized proprietary C-CAR011 construct of CD19 CAR-T therapy in patients with relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia. . .Good data should translate into a larger Phase 2 trial," Zhou wrote.
2. CARD-1 is a "nine-patient, dose escalation study evaluating safety efficacy and C-CAR011 cell persistence in patients with relapsed or refractory diffuse large B-cell lymphoma. . .Patient enrollment (n=9) is currently underway," said Zhou.
In other news, Cellular Biomedicine "received a $2.3M award from California Institute for Regenerative Medicine to support the company's allogeneic human adipose-derived mesenchymal stem cells AlloJoin for the treatment of knee osteoarthritis in the U.S.," indicated Zhou.
Looking forward, by the end of 2017, the biomedicine firm "expects to have a combined 70,000 square feet of GMP manufacturing space between Shanghai, an expanded Wuxi-based facility and the facility in Beijing," said Zhou. "These three facilities could simultaneously support clinical development of five CAR-T and stem cell therapy products, or up to 10,000 patient CAR-T treatments and 10,000 stem cell therapies per year."
These developments are the result of Cellular Biomedicine's previously announced collaboration with GE Healthcare Life Sciences China, Zhou added, "to co-develop industrial control processes in CAR-T and stem cell manufacturing."
Maxim Group has a Buy rating and 12-month target price of $18 per share on the company. Its stock currently trades at roughly $8.50 per share.
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Disclosures from Maxim Group, Cellular Biomedicine Group, Company Update, Aug. 9, 2017
I, Gabrielle Zhou, attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report.
I, Jason Kolbert, attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report.
I, Jason McCarthy, Ph.D., attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report.
The research analyst(s) primarily responsible for the preparation of this research report have received compensation based upon various factors, including the firm’s total revenues, a portion of which is generated by investment banking activities.
Maxim Group provides non-investment banking securities-related services to Cellular Biomedicine Group for the execution of its employee stock purchase plan.
Maxim Group makes a market in Cellular Biomedicine Group.
Maxim Group expects to receive or intends to seek compensation for investment banking services from Cellular Biomedicine Group in the next 3 months.