Fortress Biotech Reports First Quarter 2023 Financial Results and Recent Corporate Highlights Fortress is advancing several late-stage clinical assets with two NDA submissions anticipated in second half of 2023 PDUFA goa

Fortress Biotech Reports First Quarter 2023 Financial Results and Recent Corporate Highlights

Fortress is advancing several late-stage clinical assets with two NDA submissions anticipated in second half of 2023

PDUFA goal date of January 3, 2024 set by FDA for cosibelimab to treat metastatic or locally advanced cutaneous squamous cell carcinoma

Miami, FL - May 15, 2023 - 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, 2023.

Lindsay A. Rosenwald, M.D., Fortress' Chairman, President and Chief Executive Officer, said, "Fortress and our subsidiaries and partner companies continued advancing our promising clinical-stage drug candidates for a wide range of diseases during the first quarter of 2023. We expect data updates from multiple clinical programs in the coming months, including Phase 3 topline results for DFD-29 to treat papulopustular rosacea ("PPR") in June of 2023. We also expect to report dose escalation and response data for MB-106, a CD20-targeted, autologous CAR T cell therapy to treat relapsed or refractory B-cell non-Hodgkin lymphomas ("B-NHL") and chronic lymphocytic leukemia ("CLL"), throughout the year. Dotinurad for the treatment of gout and Triplex for the treatment of cytomegalovirus continue to advance in clinical trials and we anticipate a dotinurad Phase 1 topline data readout in U.S. healthy volunteers in the second quarter of this year."

Dr. Rosenwald continued, "On the regulatory front, we expect the rolling New Drug Application ("NDA") submission for CUTX-101 to treat Menkes disease to be complete by the end of 2023. We also anticipate filing an NDA for DFD-29 in the second half of 2023 and look forward to the January 3, 2024, Prescription Drug User Fee Act ("PDUFA") goal date for cosibelimab to treat patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC"). Overall, it is an exciting time for Fortress as we advance potential treatments for patients in need while focusing on increasing shareholder value."

Recent Corporate Highlights1:

Cosibelimab (Anti PD-L1 antibody)

1 The development programs depicted in this press release include product candidates in development at Fortress, at Fortress' private subsidiaries (referred to herein as "subsidiaries"), at Fortress' public subsidiaries (referred to herein as "partner companies") and at entities with which one of the foregoing parties has a significant business relationship, such as an exclusive license or an ongoing product-related payment obligation (such entities referred to herein as "partners"). The words "we", "us" and "our" may refer to Fortress individually, to one or more of our subsidiaries and/or partner companies, or to all such entities as a group, as dictated by context.

Dotinurad (Urate Transporter (URAT1) Inhibitor)

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

CUTX-101 (Copper Histidinate for Menkes disease)

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

Triplex (Cytomegalovirus ("CMV") vaccine)

2 Information on clinicaltrials.gov does not constitute part of this release.

In vivo CAR T Platform Technology

Marketed Dermatology Products and Product Candidates

3 M. Zanovello et al., Unexpected frequency of the pathogenic ARCAG repeat 2 expansion in the general population. Brain, in press (2023).

To assist our stockholders in understanding our company, we have prepared non-GAAP financial metrics for the three months ended March 31, 2023 and 2022. These metrics exclude the operations of our four public partner companies: 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 comprise our privately held development-stage entities, as well as our business development and finance functions.

Use of Non-GAAP Measures:

In addition to the GAAP financial measures as presented in our filings with the Securities and Exchange Commission ("SEC"), including our Form 10-Q to be filed on May 15, 2023, 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 costs, defined as GAAP research and development costs, less research and development costs of our public partner companies and non-GAAP selling, general and

administrative costs, defined as GAAP selling, general and administrative costs, 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 costs and non-GAAP selling, 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 eight 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, City of Hope, Fred Hutchinson Cancer Center, St. Jude Children's Research Hospital, Nationwide Children's Hospital and Sentynl. 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 approval, 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; financing and strategic agreements and relationships; our need for substantial additional funds and uncertainty relating to financings; our ability to identify, acquire, close and integrate product candidates successfully and on a timely basis; our ability to attract, integrate and retain key personnel; the early stage of products under development; 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; the ability to secure and maintain third-party manufacturing, marketing and distribution of our and our partner companies' products and product candidates; 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. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein.

Fortress Biotech, Inc.

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