On March 29, 2023 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 full year ended December 31, 2022 (Press release, Mustang Bio, MAR 29, 2023, View Source [SID1234629499]).

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "In 2022, we advanced our cell and gene therapy programs and presented promising research supporting the potential of our clinical portfolio at several prestigious medical meetings. Our lead clinical candidate is MB-106, a CD20-targeted, autologous CAR T cell therapy to treat relapsed or refractory B-cell non-Hodgkin lymphomas ("B-NHL") and chronic lymphocytic leukemia ("CLL"). MB-106 continues to generate compelling safety and efficacy data and remains attractive when compared to approved autologous CAR Ts, which are generating an annualized run rate of $3 billion in net sales, based on reported sales in the third quarter of 2022. MB-106 data to date include an overall response rate ("ORR") of 96% and complete response ("CR") rate of 75% in a wide range of hematologic malignancies, including Waldenstrom macroglobulinemia ("WM"), in a clinical trial conducted by our collaborators at Fred Hutchinson Cancer Center ("Fred Hutch"). We expect to disclose additional data from this trial at medical meetings in the second quarter. In parallel, Mustang’s multicenter, open-label, non-randomized Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106 continues to accrue, and we anticipate escalation to the final dose level in the Phase 1 indolent lymphoma arm in the second quarter. The FDA granted Orphan Drug Designation to MB-106 for the treatment of WM, and we have already treated the first WM in the indolent lymphoma arm of the trial. We expect that results from this arm will support an accelerated Phase 2 registration strategy for WM, with the first pivotal Phase 2 WM patient potentially to be treated in the first quarter of 2024. In 2023, we plan to report safety and efficacy data from the indolent lymphoma arm at medical meetings in the second quarter, with disclosure of updated data expected in the fourth quarter."

Financial Results:

● As of December 31, 2022, Mustang’s cash and cash equivalents and restricted cash totaled $76.7 million, compared to $110.6 million as of December 31, 2021, a decrease of $33.9 million year-over-year.
● Research and development expenses were $62.5 million for the year ended December 31, 2022. This compares to $49.9 million for 2021. Non-cash, stock-based compensation expenses included in research and development were $1.6 million for the year ended December 31, 2022, compared to $2.3 million for 2021.
● Research and development expenses from license acquisitions totaled $1.5 million for the year ended December 31, 2022, compared to $5.8 million for 2021. Non-cash, stock-based compensation expenses included in research and development – licenses acquired were $1.1 million for the year ended December 31, 2022, compared to $4.2 million for 2021.
● General and administrative expenses were $12.2 million for the year ended December 31, 2022. This compares to $11.0 million for 2021. Non-cash, stock-based compensation expenses included in general and administrative expenses were $0.9 million for the year ended December 31, 2022, compared to $2.9 million for 2021.
● Net loss attributable to common stockholders was $77.5 million, or $0.75 per share, for the year ended December 31, 2022, compared to a net loss attributable to common stockholders of $66.4 million, or $0.76 per share, for 2021.
2022 and Recent Corporate Highlights:

● In March 2022, Mustang completed a $75 million debt financing with Runway Growth Capital. Thirty million was funded upon closing, with the additional $45 million available upon Mustang achieving certain milestones.
● In June 2022, Mustang announced that the FDA granted Orphan Drug Designation to MB-106 for the treatment of WM, a rare type of B-NHL. Mustang plans to treat additional patients with WM in the Mustang Bio-sponsored Phase 1 portion of its multicenter trial in order to potentially support an accelerated Phase 2 strategy for this indication.
● In October 2022, Mustang announced that the first patient was treated in Mustang’s multicenter, open-label, non-randomized Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106, for the treatment of relapsed or refractory B-NHL and CLL. In 2023, the Company anticipates dose escalation and reporting response data at major medical meetings.
● Additionally, in October 2022, Mustang shared interim data from 28 patients treated in the initial, ongoing Phase 1/2 investigator-sponsored clinical trial at Fred Hutch. These data continue to support MB-106 as a viable CAR T cell therapy for B-NHLs and CLL. An ORR of 96% and CR rate of 75% were observed in a wide range of hematologic malignancies including follicular lymphoma ("FL"), CLL, diffuse large B-cell lymphoma ("DLBCL") and WM. Twelve patients have experienced CR for more than 12 months (10 ongoing), including four patients with CR for more than two years and the longest patient with CR at 33 months. Six patients with initial partial response at 28 days post-treatment improved to CR, presumably due to the demonstrated persistence of CAR T cells in these patients, and all remain in ongoing CR. All three patients previously treated with CD19 CAR T cell therapy responded to treatment with MB-106. A favorable safety profile for MB-106 as an outpatient therapy remains, with no cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome ≥ Grade 3 reported to date on this trial.
● Mustang continues to collaborate with the Mayo Clinic to progress our exclusively licensed novel in vivo CAR T technology platform 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. Mustang anticipates the publication of proof-of-concept research in a murine tumor model in 2023.