Core Insights - Fortress Biotech, Inc. announced significant developments including FDA approvals for Emrosi™ and UNLOXCYT™, and the acceptance of a New Drug Application for CUTX-101, indicating a transformative fourth quarter for the company [2][7] - The acquisition of Checkpoint Therapeutics by Sun Pharma is expected to enhance patient access to UNLOXCYT and provide Fortress with approximately $28 million at closing, along with a 2.5% royalty on net sales [2][3] - Fortress aims to leverage its pipeline of late clinical-stage candidates and recently approved products to drive revenue growth and shareholder value [2][10] Recent Corporate Highlights - Fortress' subsidiary Checkpoint Therapeutics is set to be acquired by Sun Pharma, with Fortress holding approximately 6.9 million shares of Checkpoint and eligible for a 2.5% royalty on future sales of UNLOXCYT [3] - The acquisition agreement includes an upfront cash payment of $4.10 per share for Checkpoint stockholders, plus a contingent value right potentially worth an additional $0.70 [3] - Fortress raised approximately $21.1 million through equity offerings in 2024, while Checkpoint raised about $32.8 million during the same period [11] Regulatory Updates - The FDA approved Emrosi (Minocycline Hydrochloride Extended-Release Capsules, 40mg) for treating inflammatory lesions of rosacea in November 2024, with commercial launch initiated in March 2025 [7][2] - UNLOXCYT was approved by the FDA in December 2024 for treating metastatic or locally advanced cutaneous squamous cell carcinoma [7] - The FDA accepted the New Drug Application for CUTX-101 for priority review, with a PDUFA goal date set for September 30, 2025 [7][2] Clinical Updates - Phase 3 clinical trials for Emrosi demonstrated its efficacy, safety, and tolerability in treating moderate-to-severe papulopustular rosacea, with results published in the Journal of the American Medical Association - Dermatology [7] - Clinical data for UNLOXCYT presented at the European Society for Medical Oncology Congress 2024 showed improved response rates over time [7] - A Phase 2 clinical trial for Triplex, a cytomegalovirus vaccine, commenced in January 2025, targeting patients undergoing hematopoietic stem cell transplantation [7] Financial Results - Fortress reported consolidated net revenue of $57.7 million for the year ended December 31, 2024, down from $84.5 million in 2023, with product revenue from dermatology products totaling $55.1 million [10][17] - Consolidated research and development expenses decreased to $56.9 million in 2024 from $106.1 million in 2023 [10][17] - The net loss attributable to common stockholders was $(55.9) million, or $(2.69) per share, for the year ended December 31, 2024, compared to a net loss of $(68.7) million, or $(8.47) per share, in 2023 [10][17]

Fortress Biotech, Inc. (NASDAQ:FBIO) Q4 2024 Earnings Conference Call March 26, 2025 4:30 PM ET Company Participants Jaclyn Jaffe - Senior Director, Corporate Operations Claude Maraoui - Co-Founder, President and CEO Joseph Benesch - CFO Srinivas Sidgiddi - VP, R&D Louis Donati - Director, Market Access Conference Call Participants Thomas Flaten - Lake Street Capital Markets Scott Henry - AGP Brandon Folkes - Rodman & Renshaw Jason Wittes - ROTH Capital Kalpit Patel - B. Riley Securities Operator Ladies and ...

FRANKFURT, Germany and MIAMI, March 17, 2025 (GLOBE NEWSWIRE) -- Partex NV and Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company, today announced a strategic collaboration aimed at identifying and evaluating biopharmaceutical compounds using artificial intelligence (AI) for potential acquisition or licensing by Fortress. Partex will deploy its proprietary AI-based drug discovery and development technology platform, which delivers diverse recommendations on alternati ...

WORCESTER, Mass., Feb. 10, 2025 (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 therapies into potential cures for difficult-to-treat cancers, today announced the closing of its previously announced public offering, for the issuance and sale of an aggregate of 2,657,807 shares of its common stock (or common stock equivalents in lieu thereof), Series C-1 warrants to purcha ...

WORCESTER, Mass., Feb. 06, 2025 (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 therapies into potential cures for difficult-to-treat cancers, today announced the pricing of a public offering of an aggregate of 2,657,807 shares of its common stock (or common stock equivalents in lieu thereof), Series C-1 warrants to purchase up to 2,657,807 shares of common stock and Seri ...

Study is the first randomized, controlled trial examining a vaccine's effectiveness in controlling CMV in recipients of HSCT from vaccinated donors Encouraging pilot study results demonstrated the benefit of vaccinating donors with Triplex to convey protective CMV-specific T cell immunity to allogeneic HSCT recipients at risk for CMV reactivation MIAMI, Jan. 27, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ:FBIO) ("Fortress"), and its majority-owned subsidiary, Helocyte, Inc. ("Helocyte"), today a ...

Reverse Stock Split - Mustang Bio Inc announced a 1-for-50 reverse stock split of its issued and outstanding common stock, effective from January 16, 2025 [1] - The reverse stock split was approved by the Board of Directors and stockholders representing approximately 56% of the voting power on June 27, 2024 [2] - The number of outstanding shares will be reduced from approximately 64.8 million to approximately 1.3 million, with no fractional shares issued and proportional cash payments made instead [3] Compliance and Trading Details - The reverse stock split aims to bring the company into compliance with Nasdaq's $1.00 per share minimum bid price requirement for continued listing [2] - Mustang's common stock will continue to trade on Nasdaq under the symbol "MBIO" with a new CUSIP number of 62818Q302 [3] - VStock Transfer LLC is acting as the exchange and paying agent for the reverse stock split, providing instructions for physical share certificate exchanges [4] Company Overview - Mustang Bio Inc is a clinical-stage biopharmaceutical company focused on developing cell therapies for difficult-to-treat cancers [5] - The company partners with top medical institutions to advance CAR-T therapies and aims to license or acquire technologies for research and development [5] - Mustang was founded by Fortress Biotech Inc and its common stock is registered under the Securities Exchange Act of 1934 [5]

Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025 Cyprium is eligible to receive royalties and up to $129 million in aggregate development and sales milestones Cyprium also retains ownership over any Priority Review Voucher that may be issued at NDA approval MIAMI, Jan. 06, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced the acceptance for review of th ...

Six-month priority review granted for CUTX-101 copper histidinate with PDUFA target action date set for June 30, 2025CUTX-101 has potential to be the first FDA-approved treatment for Menkes disease, a rare and fatal pediatric diseaseSOLANA BEACH, Calif. and AHMEDABAD, India and MIAMI, Jan. 6, 2025 /PRNewswire/ -- Sentynl Therapeutics, Inc. ("Sentynl"), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. ("Zydus Group"), and Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress") annou ...

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 September 30, 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 oth ...