Fortress Biotech Q2 2024 Financial Results and Corporate Highlights

Fortress Biotech, Inc. (Nasdaq: FBIO), an innovative biopharmaceutical company, announced its financial results and corporate highlights for the second quarter ending June 30, 2024. The company focuses on acquiring and advancing assets to enhance long-term value for its shareholders through product revenue, equity holdings, and dividend and royalty revenue.

Dr. Lindsay A. Rosenwald, Fortress’ Chairman, President, and CEO, emphasized the productive first half of the year and the anticipation for the second half. Key regulatory filings include a New Drug Application (NDA) for DFD-29 for rosacea and a Biologics License Application (BLA) for cosibelimab for metastatic and locally advanced cutaneous squamous cell carcinoma (cSCC). Both applications have PDUFA goal dates set for the fourth quarter of 2024. Additionally, late-stage candidates could potentially generate up to three regulatory approvals within the next 12 months, and a fourth BLA submission is expected as early as 2025.

In the second quarter of 2024, product revenue from marketed dermatology products reached $14.9 million, reflecting a 15% growth compared to the first quarter’s $13.0 million. The company continues to prioritize development and expand additional revenue streams to benefit shareholders, leveraging its business model for acquiring new assets and growing subsidiary and partner companies.

Regulatory updates include the FDA's acceptance of the NDA for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) with a PDUFA goal date of November 4, 2024. DFD-29 showed superior results in Phase 3 clinical trials compared to Oracea capsules and placebo for treating inflammatory lesions and erythema of rosacea. Additionally, the FDA accepted the BLA resubmission for cosibelimab, an investigational anti-PD-L1 antibody for treating metastatic or locally advanced cSCC, with a PDUFA goal date of December 28, 2024.

Clinical updates included the completion of dosing in a Phase 1b/2a study evaluating AJ201 for treating spinal and bulbar muscular atrophy (SBMA). The Phase 2 clinical trial of Triplex, a cytomegalovirus (CMV) vaccine, is fully enrolled in adults co-infected with HIV and CMV, with topline data expected in the fourth quarter of 2024. Furthermore, the first patient was dosed in a Phase 2 study of Triplex in liver transplant patients, supported by a grant from the National Institute of Allergy and Infectious Diseases.

Other updates include a collaboration with GC Cell to explore the therapeutic potential of cosibelimab combined with Immuncell-LC, an autologous cytokine-induced killer T cell therapy. Urica Therapeutics, a majority-owned subsidiary, entered into agreements with Crystalys Therapeutics, transferring rights to its URAT1 inhibitor product candidate for the treatment of gout in exchange for a 35% equity stake in Crystalys and future royalty payments.

Commercially, Journey Medical’s total net revenues for the second quarter were $14.9 million, up from $13.0 million in the first quarter. In corporate developments, Avenue Therapeutics raised $4.4 million through warrant exercise, Mustang Bio raised $6.5 million through stock offerings, and Checkpoint Therapeutics raised $12 million in a direct offering. Fortress’ Board of Directors decided to pause dividend payments on its 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock to maintain financial flexibility.

Financially, Fortress reported consolidated cash and cash equivalents of $76.2 million as of June 30, 2024, down from $83.8 million as of March 31, 2024. Consolidated revenue for the second quarter totaled $14.9 million, primarily from dermatology products. Research and development expenses were $12.7 million, and selling, general, and administrative costs were $20.8 million. The net loss attributable to common stockholders was $13.3 million for the second quarter, compared to $26.9 million for the same period in 2023.