Core Insights - Fortress Biotech is advancing its late-stage pipeline, with potential for up to three regulatory approvals in the next 12 months and a possible fourth BLA filing by 2025 [1][2] - The FDA has accepted the NDA for DFD-29, aimed at treating rosacea, with a PDUFA goal date set for November 4, 2024 [1][3] Financial Performance - Fortress reported a 7% year-over-year growth in product revenue for Q1 2024, driven by over 20% growth in flagship products Qbrexza® and Accutane® [2] - Consolidated net revenue for Q1 2024 was $13.0 million, compared to $12.4 million in Q1 2023, all from marketed dermatology products [7][11] - The consolidated net loss attributable to common stockholders for Q1 2024 was $(17.7) million, or $(1.03) per share, an improvement from a net loss of $(23.5) million, or $(3.47) per share in Q1 2023 [11][17] Regulatory Milestones - The NDA for DFD-29 was submitted in January 2024, with successful Phase 3 trials demonstrating statistical superiority over Oracea and placebo [3][4] - The company is also pursuing a rolling NDA for CUTX-101, expected to be completed in 2024, and plans to resubmit the BLA for cosibelimab by mid-2024 after addressing FDA feedback [3][4] Clinical Developments - The Phase 2 clinical trial for Triplex, a CMV vaccine for adults co-infected with HIV and CMV, is fully enrolled, with topline data expected in Q4 2024 [6] - A Phase 1b clinical trial for dotinurad, targeting gout and hyperuricemia, is ongoing, with data anticipated in mid-2024 [6] Corporate Highlights - Fortress raised approximately $11.0 million in a registered direct offering in January 2024, contributing to a consolidated cash position of $85.8 million as of March 31, 2024 [7][11] - Journey Medical, a partner company, reported total revenues of $13.0 million for Q1 2024, reflecting a 7% increase from the previous year [4]
Fortress Biotech Reports First Quarter 2024 Financial Results and Recent Corporate Highlights