On May 12, 2022 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 first quarter ended March 31, 2022 (Press release, Mustang Bio, MAY 12, 2022, View Source [SID1234614361]).
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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "Mustang started strong in 2022, with multiple data announcements and key clinical milestones achieved across our robust pipeline of CAR T cell and gene therapies. In the first quarter, data were presented on three of our CAR T cell therapies and our oncolytic virus clinical candidate at prestigious medical conferences by our academic collaborators at City of Hope and Fred Hutchinson Cancer Center ("Fred Hutch"). City of Hope’s Dr. Tanya Dorff presented Phase 1 clinical trial data on MB-105, our prostate stem cell antigen ("PSCA") chimeric antigen receptor ("CAR") T-cell therapy for treatment of PSCA-positive metastatic castration-resistant prostate cancer ("mCRPC") at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Genitourinary ("GU") Cancers Symposium that demonstrated its potential as a PSCA-targeted CAR T-cell therapy for prostate cancer and other solid tumors that express PSCA. Fred Hutch’s Dr. Mazyar Shadman presented updated interim Phase 1/2 clinical trial data on MB-106, our CD20-targeted, autologous CAR T cell therapy for treatment of relapsed or refractory B-cell non-Hodgkin lymphomas ("NHL") and chronic lymphocytic leukemia ("CLL"), at the 2022 Tandem Meetings I Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research ("2022 Tandem Meetings") and at the 4th International Workshop on CAR-T and Immunotherapies ("iwCAR-T"). The data demonstrated high efficacy and a favorable safety profile, with an overall response rate ("ORR") of 96% and complete response ("CR") rate of 72% observed in all patients across all dose levels. The data included two patients previously treated with CD19-directed CAR T therapy who relapsed and responded to MB-106, demonstrating its potential as an immunotherapy option for these patients. Additionally, City of Hope’s Dr. Christine Brown presented Phase 1 clinical trial data from a late-breaking poster regarding MB-108 (C134 oncolytic virus licensed from Nationwide Children’s Hospital) and MB‐101 (IL13Rα2‐targeted CAR T cell therapy licensed from City of Hope) for the treatment of recurrent glioblastoma ("rGBM"), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting 2022 that support the safety of administering these two therapies sequentially to optimize treatment in a regimen designated as MB-109."
"Looking ahead, we have additional upcoming data presentations for MB-106 at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 ("EHA2022") Hybrid Congress and for our MB-107 gene therapy for the treatment of X-linked severe combined immunodeficiency ("XSCID") in newly diagnosed infants under the age of two at the American Society of Gene & Cell Therapy ("ASGCT") 25th Annual Meeting. We plan to dose the first patient under Mustang’s IND in a multicenter Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106 for relapsed or refractory B-NHL and CLL at the end of this quarter. In the second half of 2022, we plan to file an IND to initiate a Phase 1 clinical trial for MB-109 for the treatment of rGBM and enroll the first patient in a pivotal multicenter Phase 2 clinical trial under Mustang’s IND to evaluate MB-107. It’s an incredibly exciting time for our team and we look forward to continuing to advance our cell and gene therapies to help meet the needs of patients with hard-to-treat diseases."
Financial Results:
●As of March 31, 2022, Mustang’s cash and cash equivalents and restricted cash totaled $123.2 million, compared to $110.6 million as of December 31, 2021, an increase of $12.6 million year-to-date.
●Research and development expenses were $16.3 million for the first quarter of 2022, compared to $11.6 million for the first quarter of 2021. Non-cash, stock-based expenses included in research and development were $0.5 million for the first quarter of 2022, compared to $0.7 million for the first quarter of 2021.
●General and administrative expenses were $3.3 million for the first quarter of 2022, compared to $3.5 million for the first quarter of 2021. Non-cash, stock-based expenses included in general and administrative expenses were $1.0 million for the first quarter of 2022, compared to $1.5 million for the first quarter of 2021.
●Net loss attributable to common stockholders was $19.8 million, or $0.20 per share, for the first quarter of 2022, compared to a net loss attributable to common stockholders of $15.0 million, or $0.19 per share, for the first quarter of 2021.
Recent Corporate Highlights:
●In February 2022, Mustang was selected as the Bronze winner for the Central region in the Eighteenth Annual Team Massachusetts Economic Impact Awards presented by MassEcon. The award winners were honored at Gillette Stadium on April 7, 2022.
●Also in February 2022, Phase 1 data on MB-105, a PSCA-targeted CAR T cell therapy administered systemically to patients with PSCA-positive mCRPC, were presented by City of Hope at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium. The data indicated that PSCA-targeted CAR T-cell therapy is feasible in patients with mCRPC with dose-limiting toxicity ("DLT") of cystitis and is associated with preliminary anti-tumor effect at a dose of 100 million cells plus lymphodepletion. It was concluded that escalation up to the next dose level of 300 million cells plus modified lymphodepletion can proceed in the trial.
●In March 2022, Mustang completed a $75 million long-term debt facility with Runway Growth Capital LLC (with $30.0 million funded on the closing date and the remaining $45.0 million becoming available if Mustang achieves certain predetermined milestones).
●In April 2022, Mustang announced that interim Phase 1/2 data on MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell NHL and CLL, were presented at the 2022 Tandem Meetings. Data demonstrated high efficacy and a favorable safety profile in all patients (n=25). Five dose levels were used during the study, and complete responses were observed at all dose levels. Durable responses were observed in a wide range of hematologic malignancies including follicular lymphoma ("FL"), CLL, diffuse large B-cell lymphoma ("DLBCL"), and Waldenstrom macroglobulinemia. An ORR of 96% and CR rate of 72% was observed in all patients across all dose levels. Additionally, two patients had been previously treated with CD19-directed CAR T therapy and subsequently relapsed, and both responded to treatment, one patient with FL with a CR and the other with DLBCL with a partial response. A copy of the abstract can be viewed on the meeting website here. Mustang expects to dose the first patient in a multicenter Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106 for relapsed or refractory B-NHL and CLL later this quarter.
●Also in April 2022, MB-106 data focused on CLL were presented at the 4th iwCAR-T.
●Additionally, in April 2022, Mustang announced its plan to file an IND in the second half of 2022 to initiate a Phase 1 clinical trial combining CAR T cells and an oncolytic virus for the treatment of rGBM, supported by interim data from two ongoing investigator-sponsored Phase 1 clinical trials evaluating two clinical candidates, MB‐101 (IL13Rα2‐targeted CAR T cell therapy licensed from City of Hope) and MB-108 (C134 oncolytic virus licensed from Nationwide Children’s Hospital). The data are from a late-breaking poster presented at the AACR (Free AACR Whitepaper) Annual Meeting 2022. Preclinical data also presented support the safety of administering these two therapies sequentially to optimize treatment in a regimen designated as MB-109.
●In May 2022, Mustang announced that MB-106 CD20-targeted CAR T therapy data were selected for an oral presentation at EHA (Free EHA Whitepaper)2022 taking place June 9 – 12 in Vienna. Dr. Mazyar Shadman of Fred Hutch will present updated interim data from the ongoing Phase 1/2 clinical trial for B-NHL and CLL. A copy of the abstract can be viewed online through the EHA (Free EHA Whitepaper)2022 website here.
●In May 2022, Mustang announced that interim Phase 1/2 data on MB-107, Mustang’s lentiviral gene therapy for the treatment of XSCID, also known as bubble boy disease, in newly diagnosed infants under the age of two, were selected for an oral presentation during the Clinical Trials Spotlight Symposium at the ASGCT (Free ASGCT Whitepaper) 25th Annual Meeting taking place May 16-19, 2022, both virtually and in Washington, D.C. The presentation will include updated data from a multicenter Phase 1/2 clinical trial for XSCID in newly diagnosed infants under the age of two at St. Jude Children’s Research Hospital, UCSF Benioff Children’s Hospital in San Francisco and Seattle Children’s Hospital. The abstract can be viewed on the meeting website here.
●In the second half of 2022, Mustang expects to enroll the first patient in a pivotal multicenter Phase 2 clinical trial under Mustang’s IND to evaluate MB-107, a lentiviral gene therapy for the treatment of infants under the age of two with XSCID.
●Mustang filed an IND application in December 2021 for its pivotal multicenter Phase 2 clinical trial of MB-207, a lentiviral gene therapy for the treatment of patients with XSCID who have been previously treated with hematopoietic stem cell transplantation ("HSCT") and for whom re-treatment is indicated. The trial is currently on hold pending CMC clearance from the FDA and, based on feedback from the Agency, Mustang Bio expects to enroll the first patient in a pivotal multicenter Phase 2 clinical trial in the first quarter of 2023.