Rafael Holdings Inc (NYSE American: RFL) is a healthcare holding company that develops and manages a portfolio of early-stage pharmaceutical and medical device subsidiaries. The company does not generate meaningful commercial revenue from its portfolio; it funds subsidiary operations through its balance sheet while pursuing regulatory approvals, licensing arrangements, and strategic partnerships. Rafael Holdings operates three reportable segments: Healthcare, Infusion Technology, and Real Estate, as disclosed in its 10-K filed October 29, 2025. The Healthcare segment includes Cornerstone Pharmaceuticals, which is developing CPI-613 (devimistat), a mitochondrial metabolism disruptor targeting cancer; Cyclo Therapeutics, focused on Trappsol Cyclo for Niemann-Pick disease type C; LipoMedix, developing Promitil; and Rafael Medical Devices, which received FDA 510(k) clearance in December 2024 for its VECTR System for minimally invasive carpal and cubital tunnel release surgeries. The company holds a 73% equity interest in Rafael Medical Devices as of February 2025.
- Revenue model
- Rafael Holdings generates minimal commercial revenue. Its subsidiaries are pre-revenue or early-commercial stage. The company has entered into licensing agreements for certain pipeline assets, including a license of one Barer/Farber technology to the Ludwig Institute of Cancer Research and the sale of telaglenastat (CB-839) rights to Synhale in February 2025 for a modest upfront payment and potential future milestone payments. Rafael Medical Devices received FDA clearance for the VECTR System in December 2024 but has not disclosed commercial sales figures in the excerpted filing.
- Products and services
- CPI-613 (devimistat): a mitochondrial TCA cycle disruptor in oncology, developed by Cornerstone Pharmaceuticals, tested in three randomized controlled trials. Trappsol Cyclo (hydroxypropyl beta-cyclodextrin): a treatment for Niemann-Pick disease type C, developed by Cyclo Therapeutics. Promitil: a mitomycin lipophilic prodrug in liposomal formulation, developed by LipoMedix under exclusive license from the Hebrew University of Jerusalem via Yissum Research and Development Company. VECTR System: an orthopedic instrument for minimally invasive ligament or fascia release, including carpal tunnel and cubital tunnel release, cleared by the FDA in December 2024 as a Class II device under 510(k).
- Customers and end markets
- End markets are hospital and clinical oncology, rare disease (Niemann-Pick type C), and orthopedic surgery. Patients and healthcare providers depend on third-party payor reimbursement, including Medicare, Medicaid, commercial health insurers, and managed care organizations. No commercial customer concentration data is disclosed in the filing excerpts.
- Value-chain role
- Rafael Holdings acts as a holding company and capital allocator for early-stage pharmaceutical and medical device subsidiaries. It funds internal discovery, licenses technology from academic institutions such as Princeton University, and pursues co-development, licensing, and asset-sale arrangements. Manufacturing and clinical execution are managed at the subsidiary level, with reliance on external partners for clinical trials and manufacturing.
- Geographic exposure
- Primary operations are in the United States. LipoMedix holds exclusive licenses from Israeli institutions, including Yissum Research and Development Company (Hebrew University of Jerusalem) and Shaare Zedek Scientific Company, indicating some intellectual property originating from Israel. No geographic revenue breakdown is disclosed in the filing excerpts.
- Competitors
- Two unnamed competitors that received FDA approval for NPC treatments on September 20, 2024 and September 24, 2024, both with products commercially available in the US in 2025
Source: SEC 10-K, filed 2025-10-29
Industry:
Pharmaceutical Preparations
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