Fortress Biotech Reports First Quarter 2022 Financial Results and Recent Corporate Highlights Net revenue for first quarter of 2022 increased 106% period-over-period to $23.9 million, a company quarterly record Positive

Fortress Biotech Reports First Quarter 2022 Financial Results and Recent Corporate Highlights

Net revenue for first quarter of 2022 increased 106% period-over-period to $23.9 million, a company quarterly record

Positive topline results from registration-enabling study of cosibelimab in metastatic cutaneous squamous cell carcinoma announced in January 2022; BLA submission expected in 2022

Rolling NDA submission for CUTX-101 for the treatment of Menkes disease expected to be completed in mid-2022; CUTX-101 is eligible for a priority review voucher upon FDA approval

Ended first quarter 2022 with $289.7 million in consolidated cash, cash equivalents and restricted cash

Miami, FL - May 12, 2022 - Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, today announced financial results and recent corporate highlights for the first quarter ended March 31, 2022.

Lindsay A. Rosenwald, M.D., Fortress' Chairman, President and Chief Executive Officer, said, "Together with our subsidiaries and partner companies, Fortress had an exciting start to the year with the acquisition and commercial launch of two dermatology products, Amzeeq and Zilxi , bringing our total number of marketed prescription products to nine. Fortress also has a growing portfolio of 30 product candidates across our partner companies, including 20 separate clinical programs in 30 ongoing clinical trials. Four product candidates are in seven1 ongoing pivotal clinical trials. We were pleased to announce positive topline results from the registration-enabling study of cosibelimab in metastatic cutaneous squamous cell carcinoma ("cSCC") in January 2022. Throughout the remainder of 2022 we anticipate multiple key regulatory and clinical inflection points, such as the submission of a Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") for cosibelimab and the completion of Cyprium's CUTX-101 rolling submission of its New Drug Application ("NDA"). CUTX-101 is eligible for a priority review voucher upon FDA approval. Moreover, we expect the availability of clinical data from many product candidates in ongoing clinical trials including MB-106, MB-107, cosibelimab and Dotinurad."

Dr. Rosenwald continued, "We ended the first quarter with $289.7 million in consolidated cash, cash equivalents and restricted cash. Additionally, we attained a new company quarterly record for net revenue, $23.9 million, which is an increase of 106% period-over-period. We believe that we are well-positioned for success with multiple product candidates and remain focused on creating long-term shareholder value through asset monetizations, equity holdings/appreciation in our subsidiaries and partner companies, annual equity dividends and royalty revenues."

Recent Corporate Highlights2:

Marketed Dermatology Products and Product Candidates

CUTX-101 (Copper Histidinate for Menkes disease)

CAEL-101 (Light Chain Fibril-reactive Monoclonal Antibody for AL Amyloidosis)

Cosibelimab (formerly CK-301, an anti-PD-L1 antibody)

MB-106 (CD20-targeted CAR T Cell Therapy)

MB-107 and MB-207 (Lentiviral Gene Therapies for XSCID)

Dotinurad (Urate Transporter (URAT1) Inhibitor)

MB-105 (PSCA-targeted CAR T Cell Therapy)

MB-109 (MB-101 (IL13R 2-targeted CAR T Cell Therapy) + MB-108 Oncolytic Virus)

To assist our stockholders in understanding our company, we have prepared non-GAAP financial results for the three months ended March 31, 2022 and 2021. These results exclude the operations of our four public partner companies: Avenue Therapeutics, Inc. ("Avenue"), Checkpoint, Journey Medical and Mustang Bio, as well as any one-time, non-recurring, non-cash transactions. The goal in providing these non-GAAP financial metrics is to highlight the financial results of Fortress' core operations, which are comprised of our privately held development-stage entities, as well as our business development and finance functions. See "Use of Non-GAAP Measures" below.

Use of Non-GAAP Measures:

In addition to the GAAP financial measures as presented in this press release and that will be presented in our Form 10-Q to be filed with the Securities and Exchange Commission ("SEC") on May 12, 2022, the Company, in this press release, has included certain non-GAAP measurements. The non-GAAP net loss attributable to common stockholders is defined by the Company as GAAP net loss attributable to common stockholders, less net losses attributable to common stockholders from our public partner companies Avenue, Checkpoint, Journey Medical and Mustang Bio ("public partner companies"), as well as our former subsidiary, Caelum. In addition, the Company has also provided a Fortress non-GAAP loss attributable to common stockholders which is a modified EBITDA calculation that starts with the non-GAAP loss attributable to common stockholders and removes stock-based compensation expense, non-cash interest expense, amortization of licenses and debt discount, changes in fair values of investment, changes in fair value of derivative liability, and depreciation expense. The Company also provides non-GAAP research and development expenses including license acquisitions, defined as GAAP research and development costs, less research and development costs of our public partner companies and non-GAAP consolidated selling, general and administrative expenses, defined as GAAP selling, general and administrative expenses, less selling, general and administrative costs of our public partner companies.

Management believes each of these non-GAAP measures provide meaningful supplemental information regarding the Company's performance because (i) it allows for greater transparency with respect to key measures used by management in its financial and operational decision-making; (ii) it excludes the impact of non-cash or, when specified, non-recurring items that are not directly attributable to the Company's core operating performance and that may obscure trends in the Company's core operating performance; and (iii) it is used by institutional investors and the analyst community to help analyze the Company's standalone results separate from the results of its public partner companies. However, non-GAAP loss attributable to common stockholders and any other non-GAAP financial measures should be considered as a supplement to, and not as

a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Further, non-GAAP financial measures used by the Company and the manner in which they are calculated may differ from the non-GAAP financial measures or the calculations of the same non-GAAP financial measures used by other companies, including the Company's competitors.

The tables below provide a reconciliation from GAAP to non-GAAP measures:

Reconciliation to non-GAAP research and development and general and administrative costs:

About Fortress Biotech

Fortress Biotech, Inc. ("Fortress") is an innovative biopharmaceutical company focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates. The company has nine marketed prescription pharmaceutical products and over 30 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy, which allow it to create value for shareholders. Fortress advances its diversified pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is driven by a world-class business development team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the company's portfolio of product opportunities. Fortress has established partnerships with some of the world's leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including AstraZeneca plc, City of Hope, Fred Hutchinson Cancer Research Center, St. Jude Children's Research Hospital, Nationwide Children's Hospital and Sentynl Therapeutics, Inc. For more information, visit www.fortressbiotech.com.

Forward-Looking Statements

This 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. As used below

and throughout this press release, the words "we", "us" and "our" may refer to Fortress individually or together with one or more partner companies, as dictated by context. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs, ability to generate shareholder value, ability of our products to receive necessary approvals, including FDA, ability of our products and therapies to help patients 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, including disruptions that may result from hostilities in Europe; our dependence on third-party suppliers; risks relating to the COVID-19 outbreak and its potential impact on our employees' and consultants' ability to complete work in a timely manner and on our ability to obtain additional financing on favorable terms or at all; 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, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Jaclyn Jaffe and Bill Begien

Fortress Biotech, Inc.

Media Relations Contact:

FORTRESS BIOTECH, INC. AND SUBSIDIARIES

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FORTRESS BIOTECH, INC. AND SUBSIDIARIES

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