On August 9, 2019 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating 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 second quarter ended June 30, 2019 (Press release, Mustang Bio, AUG 9, 2019, View Source [SID1234538581]).

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "The second quarter of 2019 marked the exciting New England Journal of Medicine publication of positive Phase 1/2 data from our partner, St. Jude Children’s Research Hospital (St. Jude), which demonstrated the curative potential of MB-107, a lentiviral gene therapy for X-linked severe combined immunodeficiency (XSCID). We look forward to transferring the MB-107 IND from St. Jude to Mustang in the fourth quarter of this year. Additionally, we are delighted that the U.S. Food and Drug Administration (FDA) accepted our first Investigational New Drug (IND) application to initiate a multi-center Phase 1/2 clinical trial of MB-102 (CD123 CAR T) in acute myeloid leukemia (AML), blastic plasmacytoid dendritic cell neoplasm (BPDCN) and high-risk myelodysplastic syndrome (MDS)."

Dr. Litchman continued, "Having raised a total of $69 million in the first half of 2019, we look forward to continuing to advance the development of our gene and CAR T cell therapy product candidates in the second half of 2019 and potentially reporting additional CAR T data in the fourth quarter."

Financial Results:

·As of June 30, 2019, Mustang’s cash, cash equivalents, short-term investments (certificates of deposit) and restricted cash totaled $83.1 million, compared to $41.1 million as of March 31, 2019 and $34.6 million as of December 31, 2018, an increase of $42.0 million for the quarter and an increase of $48.5 million year-to-date.

·Research and development expenses were $6.8 million for the second quarter of 2019, compared to $3.6 million for the second quarter of 2018. Non-cash, stock-based compensation expenses included in research and development were $0.3 million for second quarter of 2019, compared to $0.6 million for the second quarter of 2018.
·Research and development expenses from license acquisitions totaled $0.2 million for the second quarter of 2019, compared to $0 million for the second quarter of 2018.
·General and administrative expenses were $3.2 million for the second quarter of 2019, compared to $1.7 million for the second quarter of 2018. Non-cash, stock-based compensation expenses included in general and administrative expenses were $1.6 million for the second quarter of 2019, compared to $0.4 million for the second quarter of 2018.
·Net loss attributable to common stockholders was $10.4 million, or $0.29 per share, for the second quarter of 2019, compared to $5.1 million, or $0.19 per share, for the second quarter of 2018.

Recent Corporate Highlights:

·In April 2019, Mustang announced that it had entered into a $20 million debt financing agreement with Horizon Technology Finance Corporation. Fifteen million of the $20 million loan was funded upon closing. The remaining $5 million may be funded upon Mustang achieving certain predetermined milestones. In connection with the debt financing, Mustang issued Horizon warrants to purchase up to 288,184 shares of its common stock at an exercise price of $3.47 per share.

·Also in April 2019, the New England Journal of Medicine published St. Jude data from a Phase 1/2 clinical trial of a lentiviral gene therapy for the treatment of newly diagnosed infants under two years old with XSCID. Data demonstrated that the lentiviral gene therapy achieved normalization of T-cell numbers in all eight newly diagnosed infants with XSCID to date and disseminated infections resolved completely in all affected infants. Seven of the eight infants treated have developed normal IgM levels to date. Four of those seven infants have discontinued monthly infusions of intravenous immunoglobulin (IVIG) therapy to date. Three of those four infants who discontinued monthly IVIG infusions have responded to vaccines to date.
·In May 2019, Mustang completed an underwritten public offering, including a full over-allotment option exercise, that raised gross proceeds of $31.6 million, excluding underwriting discounts, commissions and other offering-related expenses.
·Also in May 2019, the FDA granted Orphan Drug Designation to MB-108 (oncolytic virus C134) for the treatment of malignant glioma, a type of brain cancer with a median survival of less than 18 months.
·In July 2019, the FDA granted Orphan Drug Designation to MB-102 (CD123 CAR T) for the treatment of AML.
·In August 2019, Mustang announced that the FDA had approved its IND application to initiate a multi-center Phase 1/2 clinical trial of MB-102 (CD123 CAR T) in AML, BPDCN and high-risk MDS .