On November 12, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported financial results and recent corporate highlights for the third quarter ended September 30, 2021 (Press release, Mustang Bio, NOV 12, 2021, View Source [SID1234595454]).
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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "Mustang continued to advance the development of our CAR T therapies across multiple cancers, as well as our lentiviral gene therapies, in the third quarter of 2021. In the MB-106 abstract posted earlier this month on the American Society of Hematology (ASH) (Free ASH Whitepaper) ("ASH2021") Annual Meeting website, data from 16 patients further indicate that MB-106 CD20-targeted autologous CAR T cell therapy has a favorable safety profile as outpatient therapy, with compelling clinical activity, ongoing durable complete responses and a high rate of CAR T persistence. The overall response rate ("ORR") was 94% (15/16) with a complete response ("CR") rate of 62% (10/16). In patients with follicular lymphoma ("FL") (n=12), ORR was 92% (11/12) and CR rate was 75% (9/12). We look forward to disclosing additional interim MB-106 clinical data at ASH (Free ASH Whitepaper)2021 and to enrolling the first patient in the clinical trial under Mustang’s investigational new drug trial to further advance MB-106 for patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("NHL") or chronic lymphocytic leukemia ("CLL")."
"Earlier this month, we also announced that Mustang received a National Cancer Institute ("NCI") two-year grant to support our ongoing research and development of MB-106. We anticipate providing additional updates on our CAR T and gene therapy clinical programs in the coming months," Dr. Litchman concluded.
Recent Corporate Highlights:
In August 2021, Mustang announced that the European Medicines Agency ("EMA") granted PRIME designation to MB-107, its lentiviral gene therapy for the treatment of X-linked Severe Combined Immunodeficiency ("XSCID") in newly diagnosed infants.
Also in August 2021, Mustang announced an exclusive license agreement with Mayo Clinic for a novel technology that may be able to transform the administration of CAR T therapies and has the potential to be used as an off-the-shelf therapy.
In October 2021, Christine Brown, Ph.D., Deputy Director, T Cell Therapeutics Research Laboratory and The Heritage Provider Network Professor in Immunotherapy at City of Hope, presented updated Phase 1 clinical data regarding MB-101 (IL13Rα2‐targeted CAR T cells) for the treatment of glioblastoma at two scientific conferences, the First Annual Conference on CNS Clinical Trials, co-sponsored by the Society for Neuro-Oncology and American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Special Conference: Brain Cancer.
In November 2021, Mustang announced that the company was awarded a grant of approximately $2 million from NCI of the National Institutes of Health. This two-year award will partially fund the Mustang-sponsored multicenter trial to assess the safety, tolerability and efficacy of MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with NHL or CLL.
Also in November 2021, Mustang announced MB-106 data were selected for presentation at ASH (Free ASH Whitepaper)2021 scheduled to take place in December of this year. Dr. Mazyar Shadman of Fred Hutchinson Cancer Research Center will present updated interim data from the ongoing Phase 1/2 clinical trial for NHL and CLL. A copy of the abstract can be viewed online through the ASH (Free ASH Whitepaper)2021 website here. Mustang will host a key opinion leader webinar on December 16, 2021, featuring a presentation from Dr. Shadman, who will discuss interim results from the ongoing Phase 1/2 clinical trial investigating the safety and efficacy of MB-106 for NHL and CLL.
Earlier this week, Mustang announced the execution of an exclusive license agreement with Leiden University Medical Centre for worldwide rights to a first-in-class ex vivo lentiviral gene therapy for the treatment of RAG1 severe combined immunodeficiency ("RAG1-SCID"). The therapy, which includes low-dose conditioning prior to reinfusion of the patients’ own gene-modified blood stem cells, is currently being evaluated in a Phase 1/2 multicenter clinical trial in Europe. The ongoing clinical trial recently enrolled its first patient.
Financial Results:
As of September 30, 2021, Mustang’s cash and cash equivalents and restricted cash totaled $121.9 million, compared to $130.9 million at June 30, 2021, and $98.8 million as of December 31, 2020, a decrease of $9.0 million for the quarter and an increase of $23.1 million year-to-date.
Research and development expenses including license acquisitions were $14.7 million for the third quarter of 2021, compared to $8.3 million for the third quarter of 2020. Non-cash, stock-based expenses included in research and development were $0.7 million for the third quarter of 2021, compared to $0.3 million for the third quarter of 2020.
General and administrative expenses were $2.4 million for the third quarter of 2021, compared to $2.2 million for the third quarter of 2020. Non-cash, stock-based expenses included in general and administrative expenses were $0.3 million for the third quarter of 2021, compared to $0.8 million for the third quarter of 2020.
Net loss attributable to common stockholders was $17.0 million, or $0.19 per share, for the third quarter of 2021, compared to a net loss attributable to common stockholders of $13.0 million, or $0.23 per share, for the third quarter of 2020.