Company Contact: Jaclyn Jaffe Fortress Biotech, Inc. (781) 652-4500 ir@fortressbiotech.com Media Relations Contact: MIAMI, May 16, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ:FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will p ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-35366 FORTRESS BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 20-5157386 (State or other j ...

[Q1 2024 Overview and Corporate Highlights](index=1&type=section&id=Fortress%20Biotech%20Reports%20First%20Quarter%202024%20Financial%20Results%20and%20Recent%20Corporate%20Highlights) [CEO's Statement](index=1&type=section&id=CEO's%20Statement) The CEO highlighted **7% product revenue growth** in Q1 2024, driven by flagship products, alongside key regulatory milestones and anticipated approvals - Product revenue grew **7% year-over-year** in Q1, primarily driven by **over 20% growth** in flagship products Qbrexza and Accutane[2](index=2&type=chunk) - The company's late-stage pipeline may yield up to **three regulatory approvals** within the next 12 months, with a potential fourth BLA filing as early as 2025[1](index=1&type=chunk)[2](index=2&type=chunk) - Multiple data readouts are anticipated in 2024, including topline data for AJ201, Phase 1b data for dotinurad, and Phase 2 data for Triplex[2](index=2&type=chunk) [Recent Corporate Highlights](index=2&type=section&id=Recent%20Corporate%20Highlights) Significant pipeline progress reported, encompassing regulatory milestones, clinical advancements, commercial performance, and financing [Regulatory Milestones and Updates](index=2&type=section&id=Regulatory%20Milestones%20and%20Updates) Fortress achieved key regulatory milestones, including DFD-29 NDA acceptance, CUTX-101 submission, and planned cosibelimab BLA resubmission - The FDA accepted the New Drug Application (NDA) for DFD-29 for treating rosacea, with a PDUFA goal date of **November 4, 2024**[1](index=1&type=chunk)[6](index=6&type=chunk) - The rolling NDA submission for CUTX-101 is ongoing and expected to be completed in **2024**[6](index=6&type=chunk) - Following a Complete Response Letter (CRL) for cosibelimab citing third-party manufacturing issues, a BLA resubmission is targeted for **mid-year 2024**[6](index=6&type=chunk) - Partner AstraZeneca estimates it may submit the BLA for CAEL-101 for AL amyloidosis for FDA review as early as **2025**[6](index=6&type=chunk) [Clinical Updates](index=2&type=section&id=Clinical%20Updates) Several clinical programs advanced, including Triplex Phase 2 enrollment, new Triplex study initiation, and anticipated dotinurad data - The Phase 2 clinical trial of Triplex in adults co-infected with HIV and CMV is fully enrolled, with topline data expected in **Q4 2024**[6](index=6&type=chunk) - The first patient was dosed in a multi-center Phase 2 study of Triplex for CMV control in liver transplant patients, funded by an NIH grant of **over $20 million**[2](index=2&type=chunk)[6](index=6&type=chunk) - Data from the ongoing Phase 1b clinical trial of dotinurad for gout and hyperuricemia is expected in **mid-2024**[2](index=2&type=chunk)[6](index=6&type=chunk) [Commercial Product Updates](index=2&type=section&id=Commercial%20Product%20Updates) Journey Medical reported **$13.0 million** in total revenues for Q1 2024, representing a **7% increase** year-over-year Journey Medical Total Revenues | Company | Metric | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | :--- | | Journey Medical | Total Revenues | $13.0 million | $12.2 million | +7% | [General Corporate](index=3&type=section&id=General%20Corporate) Fortress and partner companies completed several financing activities in early 2024, securing significant capital - In January 2024, Fortress raised gross proceeds of approximately **$11.0 million** in a registered direct offering[9](index=9&type=chunk) - Partner companies Checkpoint and Avenue raised approximately **$14.0 million** and **$5.0 million**, respectively, in January 2024[9](index=9&type=chunk) - Subsequent to Q1, in May 2024, Avenue raised approximately **$4.4 million** and Mustang raised approximately **$4.0 million**[9](index=9&type=chunk) [Financial Results](index=3&type=section&id=Financial%20Results) [First Quarter 2024 Financial Performance](index=3&type=section&id=First%20Quarter%202024%20Financial%20Performance) Fortress reported **$13.0 million** in Q1 2024 net revenue, reduced operating expenses, and a net loss of **$17.7 million** Key Financial Highlights | Financial Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | **Consolidated Net Revenue** | $13.0 million | $12.4 million | | **R&D Expenses** | $24.8 million | $39.5 million | | **SG&A Costs** | $17.9 million | $25.3 million | | **Net Loss (to common stockholders)** | $(17.7) million | $(23.5) million | | **Net Loss per Share** | $(1.03) | $(3.47) | Consolidated Cash Position | Cash Position | March 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Consolidated Cash** | $85.8 million | $83.4 million | [Financial Statements](index=5&type=section&id=Financial%20Statements) [Unaudited Condensed Consolidated Balance Sheets](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) Fortress Biotech reported total assets of **$164.6 million**, liabilities of **$168.6 million**, and a stockholders' deficit of **$3.9 million** Condensed Consolidated Balance Sheet Summary | Balance Sheet Item ($ in thousands) | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $83,774 | $80,927 | | Total Assets | $164,645 | $167,526 | | Total Liabilities | $168,582 | $165,939 | | Total stockholders' equity (deficit) | $(3,937) | $1,587 | [Unaudited Condensed Consolidated Statements of Operations](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2024, the company reported **$13.0 million** net revenue, reduced operating expenses, and an improved net loss of **$17.7 million** Condensed Consolidated Statements of Operations Summary | Statement of Operations ($ in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net revenue | $13,030 | $12,429 | | Total operating expenses | $49,596 | $71,296 | | Loss from operations | $(36,566) | $(58,867) | | Net loss attributable to common stockholders | $(17,731) | $(23,545) | | Net loss per common share | $(1.03) | $(3.47) |

Helocyte, a majority-owned subsidiary of Fortress Biotech, is developing Triplex for the prevention and treatment of cytomegalovirus in multiple transplant indications, as well as HIV Study is evaluating whether Triplex is safe and effective in improving the outcomes of liver transplant recipients MIAMI, May 14, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ:FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for sharehold ...

WORCESTER, Mass., May 02, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. ("Mustang" or the "Company") (NASDAQ:MBIO), a clinical-stage biopharmaceutical company focused on translating today's medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers, today announced the closing of its previously announced public offering for the purchase and sale of an aggregate of 16,877,638 shares of its common stock (or common stock equivalents in lieu thereof), Series A-1 warrants t ...

WORCESTER, Mass., April 29, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. ("Mustang" or the "Company") (NASDAQ:MBIO), a clinical-stage biopharmaceutical company focused on translating today's medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced the pricing of a public offering of an aggregate of 16,877,638 shares of its common stock (or common stock equivalents in lieu thereof), Series A-1 warrants to purchase up to 16,8 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2023 Delaware 20-5157386 (State or Other Jurisdiction of Incorporation or Organization) (I.R.S. Employer Identification No.) 1111 Kane Concourse Suite 301 Bay Harbor Islands, FL 33154 33154 (Address of Principal Executive Offices) (Zip Code) Registrant's telephone number, including are ...

Exhibit 99.1 Fortress Biotech Reports 2023 Financial Results and Recent Corporate Highlights Record consolidated net revenue of $84.5 million for full-year 2023 Fortress may receive up to four regulatory decisions on NDAs and BLAs in the next 18 months FDA accepted New Drug Application filing for DFD-29 to treat inflammatory lesions and erythema of rosacea in adults; PDUFA goal date of November 4, 2024 Miami, FL – March 28, 2024 – Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmace ...

MIAMI, March 12, 2024 (GLOBE NEWSWIRE) -- 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 that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in a fireside chat at the 36th Annual ROTH Conference on Monday, March 18, 2024, at 2:00 p.m. PT in Dana Point, California. The Co ...

WORCESTER, Mass., March 11, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. ("Mustang" or the "Company") (NASDAQ:MBIO), a clinical-stage biopharmaceutical company focused on translating today's medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced financial results and recent corporate highlights for the full-year ended December 31, 2023. "2023 was an exciting year for Mustang filled with many highlights, including compelli ...