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Fortress Biotech Reports Third Quarter 2018 Financial Results and Recent Corporate Highlights

November 9, 2018

NEW YORK, Nov. 09, 2018 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products, today announced financial results and recent corporate highlights for the third quarter ended September 30, 2018.

Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “Fortress and our subsidiaries continued to achieve important corporate and clinical milestones in the third quarter of 2018. Mustang Bio expanded its pipeline into gene therapy by securing an exclusive worldwide license for the development of a potentially first-in-class ex vivo lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency (“X-SCID”) from St. Jude Children’s Research Hospital (“St. Jude”). Additionally, Checkpoint Therapeutics announced positive interim safety and efficacy data from its Phase 1/2 clinical trial of CK-101, a third-generation epidermal growth factor receptor (“EGFR”) inhibitor being evaluated in advanced non-small cell lung cancer (“NSCLC”). Finally, Cyprium Therapeutics’ product candidate for patients diagnosed with classic Menkes disease, CUTX-101, was granted Fast Track Designation by the U.S. Food and Drug Administration (“FDA”). We plan to continue to acquire and develop compelling and, in some instances, potentially life-saving product candidates, which could lead to maximizing long-term shareholder value.”

Financial Results:

-- As of September 30, 2018, Fortress’ consolidated cash, cash equivalents, short-term investments (certificates of deposit), cash deposits with clearing organizations and restricted cash totaled $136.1 million, compared to $168.3 million as of December 31, 2017, a decrease of $32.2 million year-to-date. -- Net revenue totaled $63.7 million for the third quarter of 2018, compared to $46.9 million for the third quarter of 2017. Total revenue as of September 30, 2018 includes $5.2 million of Fortress revenue, primarily from the sale of Journey Medical Corporation products, and $58.5 million of revenue from National Holdings Corporation1 (“National Holdings”). Total revenue as of September 30, 2017 included $2.5 million of Fortress revenue and $44.4 million of revenue from National Holdings. -- Research and development expenses were $16.1 million for the third quarter of 2018, of which $15.1 million was related to Fortress Companies. This compares to $15.9 million for the third quarter of 2017, of which $14.2 million was related to Fortress Companies. Non-cash, stock-based compensation expenses included in research and development were $1.8 million for the third quarter of 2018, compared to $1.6 million for the third quarter of 2017. -- Research and development expenses from license acquisitions were $3.7 million for the third quarter of 2018, compared to $0.3 million for the third quarter of 2017. -- General and administrative expenses were $12.2 million for the third quarter of 2018, of which $7.4 million was related to Fortress Companies. This compares to $15.1 million for the third quarter of 2017, of which $10.5 million was related to Fortress Companies. Non-cash, stock-based compensation expenses included in general and administrative expenses were $2.3 million for the third quarter of 2018, compared to $2.6 million for the third quarter of 2017. -- National Holdings’ operating expenses totaled $55.2 million for the third quarter of 2018, compared to $47.7 million for the third quarter of 2017. -- Net loss attributable to common stockholders was $16.6 million, or $0.37 per share, for the third quarter of 2018, compared to a net loss attributable to common stockholders of $27.1 million, or $0.67 per share, for the third quarter of 2017. For the first nine months of 2018, net loss attributable to common stockholders was $59.3 million or $1.36 per share, compared to $56.5 million or $1.39 per share in the first nine months of 2017.

Recent Fortress and Fortress Company Highlights: Aevitas Therapeutics, Inc.

-- In August 2018, Aevitas announced that it entered into a sponsored research agreement with the laboratory of Wenchao Song, Ph.D., at the University of Pennsylvania to evaluate Aevitas’ adeno-associated virus (“AAV”) gene therapy technology in the university’s proprietary animal models of complement-mediated diseases.

Caelum Biosciences, Inc.

-- In November 2018, Caelum announced that global longitudinal strain (“GLS”) data from the Phase 1b study of CAEL-101 (a light chain fibril-reactive monoclonal antibody 11-1F4) in patients with amyloid light chain (“AL”) amyloidosis and imaging data from a pre-clinical study have been selected for two oral presentations at the 60th American Society of Hematology (“ASH”) Annual Meeting, to be held December 1-4, 2018, in San Diego.

Checkpoint Therapeutics, Inc.

-- In September 2018, Checkpoint announced positive interim safety and efficacy data from its Phase 1/2 clinical trial of CK-101, a third-generation EGFR tyrosine kinase inhibitor (“TKI”) being evaluated in advanced NSCLC. The data were presented in an oral presentation at the International Association for the Study of Lung Cancer (“IASLC”) 19th World Conference on Lung Cancer in Toronto. CK-101 was well tolerated across multiple dose groups and safe. Durable anti-tumor activity was observed, particularly in treatment-naïve EGFR mutation-positive NSCLC patients. -- In October 2018, Checkpoint appointed Christian Béchon to its Board of Directors.

Cyprium Therapeutics, Inc.

-- In July 2018, Cyprium announced that the FDA granted Fast Track Designation to CUTX-101, a product candidate for patients diagnosed with classic Menkes disease who have not demonstrated significant clinical progression. -- In September 2018, Cyprium announced the publication of preclinical data on AAV-based gene therapy combined with subcutaneous CUTX-101 (“Copper Histidinate”) for Menkes disease in Molecular Therapy: Methods & Clinical Development.

Mustang Bio, Inc.

-- In July 2018, Mustang completed a pre-Investigational New Drug (“pre-IND”) meeting with the FDA for MB-102 (“CD123 CAR T”). Based on the meeting, Mustang expects to file an IND in the fourth quarter of 2018 to support a Phase 1/2 trial of MB-102 in acute myeloid leukemia, blastic plasmacytoid dendritic cell neoplasm and high-risk myelodysplastic syndrome. -- In August 2018, Mustang announced that it entered into an exclusive worldwide license agreement with St. Jude for the development of a potentially first-in-class ex vivo lentiviral gene therapy for the treatment of X-SCID, also known as bubble boy disease. The therapy is currently being evaluated in a Phase 1/2 multicenter trial in infants under the age of two. This study is the world’s first lentiviral gene therapy trial for infants with X-SCID. The therapy is also being investigated in patients over the age of two in a second Phase 1/2 trial at the National Institutes of Health (“NIH”). -- In October 2018, Mustang appointed Martina A. Sersch, M.D., Ph.D., as Chief Medical Officer. -- Also in October 2018, Mustang announced that a first-of-its-kind Phase 1 clinical trial evaluating the safety and effectiveness of intraventricular delivery of CAR T cells to the brains of patients with HER2-positive breast cancer with brain metastases has been initiated at City of Hope. In addition, Mustang announced that City of Hope has dosed the first patient in a Phase 1 clinical trial of HER2-specific CAR T cells in treating recurrent or refractory grade III-IV glioma. The trial will evaluate the side effects and best dose of HER2-specific CAR T cells in treating patients with grade III-IV glioma that has come back or does not respond to treatment.

About Fortress BiotechFortress is a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products. Fortress develops and commercializes products both within Fortress and through certain subsidiary companies, also known as Fortress Companies. In addition to its internal development programs, Fortress leverages its biopharmaceutical business expertise and drug development capabilities and provides funding and management services to help the Fortress Companies achieve their goals. Fortress and the Fortress Companies may seek licensing arrangements, acquisitions, partnerships, joint ventures and/or public and private financings to accelerate and provide additional funding to support their research and development programs. For more information, visit www.fortressbiotech.com.

Forward-Looking 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, 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 management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. 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; uncertainties relating to preclinical and clinical testing; risks relating to the timing of starting and completing clinical trials; 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 may be required by law.

Company Contact:Jaclyn JaffeFortress Biotech, Inc.(781) 652-4500 ir@fortressbiotech.com

Investor Relations Contact:Jeremy FefferManaging Director, LifeSci Advisors, LLC(212) 915-2568 jeremy@lifesciadvisors.com

Media Relations Contact:Tony Plohoros6 Degrees(908) 940-0135 tplohoros@6degreespr.com

1 Fortress acquired approximately 56 percent of National Holdings in September 2016.

FORTRESS BIOTECH, INC. AND SUBSIDIARIESCondensed Consolidated Balance Sheets ($ in thousands except for share and per share amounts)

September December 30, 31, 2018 2017 ---------- ---------- (Unaudited) ASSETS Current assets Cash and cash equivalents $ 95,867 $ 113,915 Accounts receivable 5,431 7,758 Short-term investments (certificates of deposit) 22,538 36,002 Cash deposits with clearing organizations 336 1,041 Receivables from broker-dealers and clearing organizations 11,884 7,395 Forgivable loans receivable 1,610 1,616 Securities owned, at fair value 6,675 1,985 Inventory 674 171 Other receivables - related party 414 618 Prepaid expenses and other current assets 14,089 12,680 - -------- - -------- Total current assets 159,518 183,181 Property and equipment, net 14,642 9,513 Restricted cash 17,358 17,387 Long-term investments, at fair value – 1,390 Intangible assets 13,935 15,223 Goodwill 18,645 18,645 Other assets 821 611 - -------- - -------- Total assets $ 224,919 $ 245,950 - -------- - -------- LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable and accrued expenses $ 37,345 $ 36,127 Accounts payable and accrued expenses - related party 153 222 Accrued commissions and payroll payable 11,974 10,065 Deferred clearing and marketing credits 629 786 Securities sold, not yet purchased, at fair value 24 151 Warrants issued - National – 5,597 Interest payable 613 887 Interest payable - related party 94 97 Notes payable, short-term (net of debt discount of $447 and $973 at September 30, 9,054 8,528 2018 and December 31, 2017, respectively) Subsidiary convertible note, short-term, at fair value 10,657 4,700 Deferred revenue 155 – Derivative warrant liability – 87 Other current liabilities 77 181 - -------- - -------- Total current liabilities 70,775 67,428 Notes payable, long-term (net of debt discount of $445 and $62 at September 30, 64,546 43,222 2018 and December 31, 2017, respectively) Subsidiary convertible note, long-term, at fair value – 10,059 Other long-term liabilities 4,961 4,739 - -------- - -------- Total liabilities 140,282 125,448 - -------- - -------- Stockholders’ equity Preferred stock, $0.001 par value, 15,000,000 authorized, 5,000,000 designated Series A shares, 1,000,000 shares issued and outstanding as of September 30, 2018 1 1 and December 31, 2017, respectively; liquidation value of $25.00 per share Common stock, $0.001 par value, 100,000,000 shares authorized, 56,183,480 and 50,991,285 shares issued and outstanding as of September 30, 2018 and December 31, 56 51 2017, respectively Common stock issuable, 347,684 and 158,015 shares as of September 30, 2018 and 495 500 December 31, 2017, respectively Additional paid-in-capital 408,615 364,148 Accumulated deficit (371,394 ) (312,127 ) - -------- - -------- Total stockholders’ equity attributed to the Company 37,773 52,573 Non-controlling interests 46,864 67,929 - -------- - -------- Total stockholders’ equity 84,637 120,502 - -------- - -------- Total liabilities and stockholders’ equity $ 224,919 $ 245,950 - -------- - --------

FORTRESS BIOTECH, INC. AND SUBSIDIARIESCondensed Consolidated Statements of Operations ($ in thousands except for share and per share amounts)(Unaudited)

For the Three Months Ended For the Nine Months Ended September 30, September 30, ---------------------------- ---------------------------- 2018 2017 2018 2017 ------------ ------------ ------------ ------------ Revenue Fortress Product revenue, net $ 5,168 $ 2,170 $ 17,366 $ 8,309 Revenue - from a related party 5 350 525 1,393 - ---------- - ---------- - ---------- - ---------- Net Fortress revenue 5,173 2,520 17,891 9,702 National Commissions 28,397 24,881 85,422 73,380 Net dealer inventory gains 482 1,789 5,601 6,666 Investment banking 19,271 8,942 43,012 26,595 Investment advisory 5,281 3,605 15,811 10,480 Interest and dividends 771 674 2,003 2,065 Transfer fees and clearing services 1,606 1,649 5,680 5,834 Tax preparation and accounting 2,444 2,527 6,835 6,527 Other 268 299 697 1,016 - ---------- - ---------- - ---------- - ---------- Total National revenue 58,520 44,366 165,061 132,563 - ---------- - ---------- - ---------- - ---------- Net revenue 63,693 46,886 182,952 142,265 - ---------- - ---------- - ---------- - ---------- Operating expenses Fortress Cost of goods sold - product revenue 1,406 505 4,546 1,852 Research and development 16,082 15,890 58,528 34,683 Research and development - licenses acquired 3,706 300 3,804 3,394 General and administrative 12,184 15,104 38,788 36,490 - ---------- - ---------- - ---------- - ---------- Total Fortress operating expenses 33,378 31,799 105,666 76,419 National Commissions, compensation and fees 48,556 39,963 141,462 118,983 Clearing fees 451 470 1,772 1,826 Communications 856 690 2,429 2,094 Occupancy 738 972 2,834 2,916 Licenses and registration 861 391 2,028 1,223 Professional fees 1,076 1,082 3,047 3,336 Interest 26 5 30 13 Underwriting costs 43 – 230 – Depreciation and amortization 871 507 2,587 1,513 Other administrative expenses 1,726 3,610 5,839 7,315 - ---------- - ---------- - ---------- - ---------- Total National operating expenses 55,204 47,690 162,258 139,219 - ---------- - ---------- - ---------- - ---------- Total operating expenses 88,582 79,489 267,924 215,638 - ---------- - ---------- - ---------- - ---------- Loss from operations (24,889 ) (32,603 ) (84,972 ) (73,373 ) Other income (expenses) Interest income 269 204 841 530 Interest expense and financing fee (2,228 ) (3,220 ) (6,455 ) (5,298 ) Change in fair value of derivative liabilities - (639 ) (7,931 ) 5,155 Change in fair value of subsidiary convertible (84 ) (74 ) 26 (359 ) note Change in fair value of investments (565 ) 270 (1,390 ) (241 ) Other expenses (146 ) (245 ) (258 ) (232 ) - ---------- - ---------- - ---------- - ---------- Total other expenses (2,754 ) (3,704 ) (15,167 ) (445 ) - ---------- - ---------- - ---------- - ---------- Loss before income taxes (27,643 ) (36,307 ) (100,139 ) (73,818 ) Income tax expense 944 – 2,382 – - ---------- - ---------- - ---------- - ---------- Net loss (28,587 ) (36,307 ) (102,521 ) (73,818 ) - ---------- - ---------- - ---------- - ---------- Less: net loss attributable to non-controlling (11,949 ) (9,191 ) (43,254 ) (17,355 ) interests - ---------- - ---------- - ---------- - ---------- Net loss attributable to common stockholders $ (16,638 ) $ (27,116 ) $ (59,267 ) $ (56,463 ) - ---------- - ---------- - ---------- - ---------- Basic and diluted net loss per common share $ (0.37 ) $ (0.67 ) $ (1.36 ) $ (1.39 ) - ---------- - ---------- - ---------- - ---------- Weighted average common shares 44,818,186 40,724,115 43,578,763 40,547,364 outstanding-basic and diluted - ---------- - ---------- - ---------- - ----------

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