On November 14, 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 third quarter ended September 30, 2022 (Press release, Mustang Bio, NOV 14, 2022, View Source [SID1234624005]).

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We continued to make progress advancing our portfolio of cell and gene therapies during the third quarter. Notably, we treated the first patient in our multicenter Phase 1/2 clinical trial to evaluate the safety and efficacy of MB-106, our first-in-class CD20-targeted, autologous CAR T cell therapy for the treatment of relapsed or refractory B-cell non-Hodgkin lymphomas ("B-NHL") and chronic lymphocytic leukemia ("CLL"). This first clinical trial under Mustang’s Investigational New Drug application ("IND") builds upon the initial, ongoing Phase 1/2 clinical trial taking place at Fred Hutchinson Cancer Center ("Fred Hutch"). In the Fred Hutch trial, MB-106 continues to demonstrate high efficacy and a favorable safety profile across patients with a wide range of hematologic malignancies. Results from the Waldenstrom macroglobulinemia ("WM") cohort of the Fred Hutch trial were recently presented at the 11th International Workshop for Waldenstrom’s Macroglobulinemia ("IWWM-11"), showing a 100% complete response ("CR") rate in patients with WM. Our MB-106 program was granted Orphan Drug Designation ("ODD") by the U.S. Food and Drug Administration ("FDA") for WM, and we plan to treat additional patients with WM in the Mustang-sponsored Phase 1 portion of our multicenter trial in order to support a fast-to-market Phase 2 strategy for this indication. We anticipate announcing early results from the Mustang-sponsored Phase 1 trial in December 2022."

"In summary, our CD20 CAR T remains our lead program, and we believe the product profile is favorable compared to the 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," said Dr. Litchman.

Recent Corporate Highlights:

In July 2022, Mustang announced that the first patient successfully received LV-RAG1 ex vivo lentiviral gene therapy to treat RAG1-SCID, in an ongoing Phase 1/2 multicenter clinical trial taking place in Europe. LV-RAG1 is exclusively licensed by Mustang for the development of MB-110, a first-in-class ex vivo lentiviral gene therapy for the treatment of RAG1-SCID.

In October 2022, Mustang announced that the first patient was treated in its multicenter, open-label, non-randomized Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106, Mustang’s first-in-class CD20-targeted, autologous CAR T cell therapy for the treatment of relapsed or refractory B-NHL and CLL. This is the first MB-106 clinical trial under Mustang’s IND.

Also 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, 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 ("PR") 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 have 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.

Additionally in October 2022, Mustang announced that results from the WM cohort and other interim data from the ongoing Phase 1/2 clinical trial of MB-106 at Fred Hutch were presented at IWWM-11 that took place in Madrid, Spain. Mustang’s MB-106 program was granted ODD by the FDA for WM, and Mustang plans to treat additional WM patients in the Mustang-sponsored Phase 1 portion of its multicenter trial in order to support a fast-to-market Phase 2 strategy for this indication.

Mustang expects to announce early results from the Mustang-sponsored multicenter MB-106 trial later this quarter.

Financial Results:

As of September 30, 2022, Mustang’s cash and cash equivalents and restricted cash totaled $92.4 million, compared to $108.4 million at June 30, 2022 and $110.6 million as of December 31, 2021, a decrease of $16.0 million for the quarter and a decrease of $18.2 million year-to-date.

Research and development expenses were $15.5 million for the third quarter of 2022, compared to $14.7 million for the third quarter of 2021. Non-cash, stock-based expenses included in research and development were $0.3 million for the third quarter of 2022, compared to $0.7 million for the third quarter of 2021.

General and administrative expenses were $3.4 million for the third quarter of 2022, compared to $2.4 million for the third quarter of 2021. Non-cash, stock-based expenses included in general and administrative expenses were $0.2 million for the third quarter of 2022, compared to $0.3 million for the third quarter of 2021.

Net loss attributable to common stockholders was $19.0 million, or $0.18 per share, for the third quarter of 2022, compared to a net loss attributable to common stockholders of $17.0 million, or $0.19 per share, for the third quarter of 2021.