GlobeNewswire Inc | Nov 6, 2020 04:20PM EST

November 06, 2020

WORCESTER, Mass., Nov. 06, 2020 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (Mustang) (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating todays medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today announced financial results and recent corporate highlights for the third quarter ended September 30, 2020.

Mustang had an eventful third quarter on the regulatory front, as the U.S. Food and Drug Administration (FDA) granted Rare Pediatric and Orphan Drug Designations to both of our gene therapy product candidates for the treatment of X-linked severe combined immunodeficiency (XSCID), MB-107, for newly diagnosed infants, and MB-207, for patients previously treated with hematopoietic stem cell transplantation (HSCT) and for whom re-treatment is indicated, said Manuel Litchman, M.D., President and Chief Executive Officer of Mustang.

Dr. Litchman continued, We are also pleased to report progress across our CAR T cell therapy programs during the third quarter and subsequent period. Most importantly, as recently reported, we have observed compelling efficacy without CAR T related toxicity in the first 4 non-Hodgkin lymphoma patients treated with MB-106, a CD20-targeted CAR T cell therapy, following a major revision in the cell manufacturing process at the Fred Hutch Cancer Research Center (Fred Hutch). We also dosed the first patient in a Phase 1/2 clinical trial of MB-102, a CD123-targeted CAR T cell therapy, under our own Investigational New Drug (IND) application for relapsed or refractory blastic plasmacytoid dendritic cell neoplasm, acute myeloid leukemia and high-risk myelodysplastic syndrome. Finally, we are encouraged by the significant response to MB-105, a prostate stem cell antigen (PSCA)-targeted CAR T therapy, reported by City of Hope in a 73-year-old patient with PSCA-positive metastatic castrate-resistant prostate cancer. This patient, who had failed eight prior therapies, experienced a 94 percent reduction in prostate-specific antigen, with a near complete reduction of measurable soft tissue metastasis by computerized tomography and improvement in bone metastases by magnetic resonance imaging. We look forward to achieving additional milestones in the coming months, as we expect to disclose additional promising clinical data from our MB-106 program at the American Society of Hematology (ASH) Annual Meeting next month. In addition, next quarter we expect to enroll the first patient on our pivotal MB-107 lentiviral gene therapy trial for newly diagnosed infants with XSCID and to file an IND for our pivotal MB-207 lentiviral gene therapy trial for previously transplanted patients with XSCID.

Recent Corporate Highlights:

-- In August 2020, Mustang announced that the FDA granted Rare Pediatric Disease Designation to MB-107, a lentiviral gene therapy for the treatment of XSCID, also known as bubble boy disease, in newly diagnosed infants and to MB-207, a lentiviral gene therapy for the treatment of patients with XSCID who have been previously treated with HSCT and for whom re-treatment is indicated. -- In September 2020, the FDA granted Orphan Drug Designation to MB-107 for the treatment of XSCID in newly diagnosed infants and to MB-207 for the treatment of patients with XSCID who have been previously treated with HSCT and for whom re-treatment is indicated. -- In October 2020, Mustang announced that the first patient had been dosed in a company-sponsored, open label, multicenter Phase 1/2 clinical trial to evaluate the safety and efficacy of MB-102 (CD123-targeted CAR T cell therapy) in patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (hrMDS). -- In October 2020, Mustang licensed LentiBOOST technology from SIRION Biotech GmbH for the development of MB-207. -- In October 2020, City of Hope presented initial Phase 1 data on MB-105, a PSCA-targeted CAR T administered systemically to patients with PSCA-positive mCRPC, at the virtual 27th Annual Prostate Cancer Foundation Scientific Retreat. -- Earlier this month, 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 non-Hodgkin lymphomas, were selected for a poster presentation at the 62nd ASH Annual Meeting. A link to the abstract can be found here.

Financial Results:

-- As of September 30, 2020, the companys cash, cash equivalents and restricted cash totaled $76.3 million, compared to $86.4 million as of June 30, 2020, and $62.4 million as of December 31, 2019. -- Research and development expenses were $8.0 million for the third quarter of 2020. This compares to $7.3 million for the third quarter of 2019. Non-cash, stock-based compensation expenses included in research and development were $0.3 million for the third quarter of 2020, compared to $0.7 million for the third quarter of 2019. -- Research and development expenses from license acquisitions totaled $0.3 million for the third quarter of 2020, compared to $0.7 million for the third quarter of 2019. -- General and administrative expenses were $2.2 million for the third quarter of 2020. This compares to $2.0 million for the third quarter of 2019. Non-cash, stock-based compensation expenses included in general and administrative expenses were $0.3 million for the third quarter of 2020, compared to $0.4 million for the third quarter of 2019. -- Net loss attributable to common stockholders was $13.0 million, or $0.23 per share, for the third quarter of 2020, compared to a net loss attributable to common stockholders of $10.2 million, or $0.25 per share, for the third quarter of 2019.

About Mustang BioMustang Bio, Inc. is a clinical-stage biopharmaceutical company focused on translating todays medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to outlicense or bring the technologies to market. Mustang has partnered with top medical institutions to advance the development of CAR T therapies across multiple cancers, as well as a lentiviral gene therapy for XSCID. Mustang is registered under the Securities Exchange Act of 1934, as amended, and files periodic reports with the U.S. Securities and Exchange Commission (SEC). Mustang was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit www.mustangbio.com.

ForwardLooking StatementsThis press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on managements current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Company Contacts:Jaclyn Jaffe and William BegienMustang Bio, Inc.(781) 652-4500ir@mustangbio.com

Investor Relations Contact:Daniel FerryLifeSci Advisors, LLC(617) 430-7576daniel@lifesciadvisors.com

Media Relations Contact:Tony Plohoros6 Degrees(908) 591-2839tplohoros@6degreespr.com

MUSTANG BIO, INC.Condensed Balance Sheets($ in thousands, except for share and per share amounts) September30, December31, 2020 2019 (Unaudited) ASSETS Current Assets: Cash and cash equivalents $ 75,251 $ 61,413 Other receivables - related party 37 19 Prepaid expenses and other current 344 1,631 assetsTotal current assets 75,632 63,063 Property, plant and equipment, net 7,250 6,779 Fixed assets- construction in process 821 1,157 Restricted cash 1,000 1,000 Other assets 250 250 Operating lease right-of-use asset, net 1,115 1,196 Total Assets $ $ 86,068 73,445 LIABILITIES AND STOCKHOLDERS? EQUITY Current Liabilities: Short-term notes payable $ ? $ 1,250 Accounts payable and accrued expenses 7,054 5,668 Payables and accrued expenses- related 305 596 partyOperating lease liabilities - short-term 271 257 Total current liabilities 7,630 7,771 Notes payable ? 12,179 Operating lease liabilities - long-term 2,022 1,843 Total Liabilities 9,652 21,793 Commitments and Contingencies Stockholders? Equity Preferred stock ($0.0001 par value),2,000,000 shares authorized, 250,000shares of ? ? ClassA preferred stock issued andoutstanding as of September30,2020 andDecember31,2019, respectivelyCommon Stock ($0.0001 par value), 85,000,000 shares authorizedClassA common shares, 845,385 sharesissued and outstandingas of ? ? September30,2020 andDecember31,2019, respectivelyCommon shares, 60,164,539 and 39,403,519shares issued and outstandingas of 5 4 September30,2020 andDecember31,2019, respectivelyCommon stock issuable, 65,810 and1,206,667 shares as of 235 4,923 September30,2020 andDecember31,2019, respectivelyAdditional paid-in capital 241,042 172,184 Accumulated deficit (164,866 ) (125,459 )Total Stockholders? Equity 76,416 51,652Total Liabilities and Stockholders? $ $ Equity 86,068 73,445



MUSTANG BIO, INC.Condensed Statements of Operations($ in thousands, except for share and per share amounts)(Unaudited)

Forthe three months ended Forthe nine months ended September30, September30, 2020 2019 2020 2019Operating expenses:Research and $ 7,987 $ 7,309 $ 27,131 $ 21,092 developmentResearch anddevelopment? 287 700 1,837 1,350 licensesacquiredGeneral and 2,153 1,987 7,100 7,520 administrativeTotaloperating 10,427 9,996 36,068 29,962 expensesLoss from (10,427 ) (9,996 ) (36,068 ) (29,962 )operations Other income (expense)Interest 162 406 567 945 incomeInterest (2,687 ) (578 ) (3,906 ) (1,163 )expenseTotal otherincome (2,525 ) (172 ) (3,339 ) (218 )(expense)Net Loss $ ) $ ) $ ) $ ) (12,952 (10,168 (39,407 (30,180 Net loss percommon shareoutstanding, $ (0.23 ) $ (0.25 ) $ (0.82 ) $ (0.87 )basic anddiluted Weightedaverage numberof commonshares 57,253,715 39,875,209 48,116,158 34,752,938 outstanding,basic anddiluted