Core Insights - Fortress Biotech, Inc. has initiated the commercial launch of Emrosi™ for treating inflammatory lesions of rosacea in adults, following FDA approval in November 2024 [4] - The company reported a net loss of $(12.7) million, or $(0.48) per share, for Q1 2025, an improvement from a net loss of $(17.9) million, or $(1.04) per share, in Q1 2024 [12][18] - Fortress' subsidiary Checkpoint Therapeutics is set to be acquired by Sun Pharma, with expected upfront cash payment of approximately $28 million and potential future royalties [3][2] Financial Results - Fortress' consolidated cash and cash equivalents increased to $91.3 million as of March 31, 2025, up from $57.3 million at the end of 2024, marking a $34 million increase [12][14] - Consolidated net product revenue for Q1 2025 was $13.1 million, slightly up from $13.0 million in Q1 2024 [9][18] - Research and development expenses for Q1 2025 totaled $3.9 million, a significant decrease from $24.8 million in Q1 2024 [12][18] Regulatory Updates - The FDA accepted the New Drug Application for CUTX-101 for Menkes disease, with a PDUFA goal date of September 30, 2025 [2][8] - UNLOXCYT, an anti-PD-L1 antibody developed by Checkpoint, was approved by the FDA in December 2024 for treating patients with metastatic or locally advanced cutaneous squamous cell carcinoma [8] Commercial Product Updates - Emrosi was launched by Journey Medical Corporation, with initial prescriptions filled at the end of March 2025 [4][18] - Full results from two Phase 3 clinical trials evaluating Emrosi were published, demonstrating its efficacy and safety for treating moderate-to-severe papulopustular rosacea [18] Corporate Highlights - Fortress has a robust pipeline with multiple late-stage programs and newly approved products, positioning the company for continued revenue growth [2] - The acquisition of Checkpoint by Sun Pharma is expected to enhance patient access to Checkpoint's products and create significant monetization opportunities for Fortress [3][2]

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]