Fortress Biotech, Inc. - Company Summary

Core Business Activities

• Fortress Biotech, Inc. is a biopharmaceutical company specializing in acquiring and advancing assets—specifically, product candidates and drug technologies—that aim to create long-term shareholder value.
• The company focuses on developing pharmaceutical and biopharmaceutical products through strategic acquisitions, licensing, and partnerships.
• Fortress collaborates with leading research institutions, universities, and pharmaceutical companies such as City of Hope, Fred Hutchinson Cancer Center, Dana-Farber, Nationwide Children’s Hospital, Columbia University, University of Pennsylvania, AstraZeneca, and Dr. Reddy’s Laboratories.
• Post licensing or acquisition of intellectual property, Fortress leverages scientific, regulatory, legal, and financial expertise to support subsidiaries and partner companies’ development and commercialization efforts.
• The company actively seeks strategic arrangements like joint ventures, licensing, out-licensing, sales, and financings to fund research and development.

Subsidiaries and Partner Companies

• Fortress’s development and commercialization efforts are carried out through several subsidiaries and partner companies, including:
  • Checkpoint Therapeutics (Nasdaq: CKPT)
  • Journey Medical Corporation (Nasdaq: DERM)
  • Mustang Bio (Nasdaq: MBIO)
  • Avenue Therapeutics (OTC: ATXI)
  • Baergic Bio (subsidiary of Avenue)
  • Cellvation
  • Cyprium Therapeutics
  • Helocyte
  • Oncogenuity
  • Urica Therapeutics

Recent Developments

• Checkpoint and UNLOXCYT:
  • UNLOXCYT (cosibelimab-ipdl), an anti-PD-L1 monoclonal antibody for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC), received FDA approval in December 2024.
  • Checkpoint entered into an acquisition agreement by Sun Pharmaceutical Industries, Inc., with completion expected in Q2 2025.
  • Fortress owns approximately 6.9 million shares of Checkpoint and is eligible to receive a royalty of 2.5% on UNLOXCYT worldwide net sales.
• Journey and Emrosi:
  • Journey received FDA approval in November 2024 for Emrosi, a minocycline hydrochloride extended-release capsule for rosacea, launched commercially in March 2025.
• Cypriuim and CUTX-101:
  • NDA accepted for copper histidinate injection (CUTX-101) for Menkes disease; FDA’s target action date is September 30, 2025.
  • The candidate has multiple FDA designations: Orphan Drug, Rare Pediatric Disease, Fast Track, and Breakthrough Therapy.
• Other Product Candidates:
  • Triplex (CMV vaccine) developed by Helocyte with ongoing clinical trials.
  • CAEL-101 (monoclonal antibody for AL amyloidosis) in Phase 3 trials.
  • Dotinurad (urate transporter inhibitor) licensed from Fuji Yakuhin, with recent approval in Japan and China.
  • MB-101 (CAR T therapy for glioblastoma) and MB-108 (HSV-1 oncolytic virus) are in clinical development.

Employees

• As of December 31, 2024, Fortress employs 101 full-time employees.

Financials

• Revenue: No current revenue from product sales; revenue primarily from partnerships and licensing.
• Operating Loss:
  • Fiscal year 2024: approximately $110.4 million (net loss).
  • Fiscal year 2023: approximately $142.3 million (net loss).
• Accumulated Deficit: Approximately $740.9 million as of December 31, 2024.
• The company continues to incur losses and expects operating costs and expenses to increase as it advances clinical trials and product development.
• Cash and cash equivalents are believed sufficient for at least the next 12 months from the filing date.

Business Focus

• The company seeks to build a pipeline with licensed and acquired product candidates, mainly in early and late-stage development, targeting oncology, dermatology, neurological, and rare diseases.
• Emphasizes strategic partnerships, licensing, and collaborations to mitigate development risks and fund growth.
• Does not currently generate revenue from product sales outside of partnerships, especially Journey’s dermatology products.

Note: The above information is exclusively based on the provided document, with no hypothetical or forward-looking statements included.