Fortress Biotech Q1 2024 Financial Results and Corporate Highlights

Fortress Biotech, Inc., a biopharmaceutical company listed on Nasdaq under the ticker FBIO, has reported its financial results and significant corporate developments for the first quarter ending March 31, 2024. The company's focus remains on acquiring and advancing assets to boost long-term shareholder value through product revenue, equity holdings, and dividend and royalty income.

The Chairman, President, and CEO, Dr. Lindsay A. Rosenwald, highlighted a 7% year-over-year increase in product revenue for the first quarter, primarily driven by more than 20% growth in flagship products Qbrexza and Accutane. The FDA has accepted the New Drug Application (NDA) for DFD-29, a treatment for the inflammatory lesions and erythema of rosacea in adults, targeting a Prescription Drug User Fee Act (PDUFA) goal date of November 4, 2024. If approved, DFD-29 could become the only oral, systemic therapy for these rosacea symptoms, setting it apart as a potential best-in-class solution for millions of patients.

Additionally, Fortress dosed the first patient in a Phase 2 multi-center study for Triplex, aiming to control cytomegalovirus (CMV) in liver transplant patients. The company also received grant funding from the National Institutes of Health (NIH) to advance cell and gene therapies for adults with HIV and children with Menkes disease. Looking ahead, Fortress expects to see up to three NDA and Biologics License Application (BLA) approvals within the next 12 months, with a potential fourth BLA filing as early as 2025. Data readouts anticipated this year include results from clinical trials of AJ201 for spinal and bulbar muscular atrophy (SBMA), dotinurad for gout and hyperuricemia, and Phase 2 data for Triplex as a CMV vaccine for adults co-infected with HIV and CMV.

Regulatory updates include the FDA acceptance of the NDA for DFD-29 in March 2024, which aims to treat rosacea with planned approval by November 4, 2024. The application demonstrated statistical superiority in clinical trials compared to Oracea capsules and placebo. The CUTX-101 rolling NDA submission is ongoing, with completion expected in 2024. Fortress' subsidiary Cyprium will retain full ownership of any FDA priority review voucher issued upon NDA approval.

The company also plans to resubmit a BLA for cosibelimab, an anti-PD-L1 antibody, following a complete response letter (CRL) from the FDA in December 2023. The CRL cited issues with a third-party manufacturer, not the clinical data or safety of cosibelimab. The resubmission is targeted for mid-year.

Clinical updates include the completion of enrollment for a Phase 2 clinical trial of Triplex as a CMV vaccine for adults with HIV, with topline data expected in Q4 2024. The study aims to demonstrate the vaccine's ability to elicit a CMV-specific immune response and reduce asymptomatic CMV replication. Another Phase 2 study for Triplex is underway for liver transplant patients, funded by an NIH grant providing over $20 million in non-dilutive funding. Additionally, a Phase 1b clinical trial for dotinurad in gout and hyperuricemia patients in the U.S. is ongoing, with data expected in mid-2024.

Commercially, Journey Medical’s total revenues for Q1 2024 were $13.0 million, a 7% increase from the previous year. Financially, Fortress raised gross proceeds of approximately $11.0 million in January 2024 through a registered direct offering. Checkpoint Therapeutics also raised $14.0 million, and Avenue Therapeutics raised $5.0 million from warrant exercises.

As of March 31, 2024, Fortress' consolidated cash, cash equivalents, and restricted cash totaled $85.8 million, compared to $83.4 million as of December 31, 2023. The company's consolidated net revenue for Q1 2024 was $13.0 million, compared to $12.4 million in Q1 2023. Research and development expenditures were $24.8 million, down from $39.5 million the previous year. The net loss attributable to common stockholders was $(17.7) million, improving from $(23.5) million in Q1 2023.