Clinical and regulatory failure
Drug candidates may not meet efficacy, safety, or approval standards.
- Scope
- Phase 3 trial and regulatory filing for Trappsol® Cyclo™
- Materiality
- high
Rafael Holdings, Inc.
Rafael Holdings, Inc. is a U.S.-based biotechnology and life sciences holding company focused on developing pharmaceuticals and medical devices through a portfolio of controlled and minority-owned subsidiaries. Its core assets include Trappsol® Cyclo™, a clinical-stage therapy for Niemann-Pick Disease Type C1, along with interests in cancer therapeutics, orthopedic devices, and an infusion-technology business. The company also retains a small real estate interest in Jerusalem, Israel.
−3 148,4 %
−3 328,2 %
+44,0 %
4.89
4.86
| % | |
|---|---|
| Clinical-stage pharmaceuticals | 55% Development of Trappsol® Cyclo™ and other drug candidates for rare disease and oncology. |
| Research product sales | 20% Sales of cyclodextrin products and related research materials used by laboratories and manufacturers. |
| Medical devices | 5% Orthopedic-focused devices and instruments intended to support minimally invasive procedures. |
| Infusion technology | 10% Technology and licensing activities tied to Unlokt™ and related manufacturing applications. |
| Real estate | 10% Residual ownership interest in a commercial building in Jerusalem, Israel. |
Customers include research buyers of cyclodextrin products, clinical and commercial partners in pharmaceutical...
- Research product customersprimary
Buy cyclodextrin products for research purposes and related applications; they value product availability and supply continuity.
- Clinical development stakeholdersprimary
Include trial sites, collaborators, and future commercial partners supporting Trappsol® Cyclo™ and other drug candidates.
- Medical device users and distributorssecondary
Hospitals, surgeons, and channel partners that would use or distribute orthopedic instruments for minimally invasive procedures.
- Manufacturing and technology customerssecondary
Third-party manufacturers using Day Three's technology to improve product formulations and process outcomes.
- Real estate counterpartiesemerging
Tenants or users associated with the Jerusalem commercial building interest.
Rafael Holdings is headquartered in Newark, New Jersey, and its operating footprint spans the United States, Israel,...
- •Headquartered in Newark, New Jersey, United States
- •Commercial building interest located in Jerusalem, Israel
- •Product sourcing from the U.S., Japan, China, and Europe
- •Clinical and development activities span multiple jurisdictions
- •Cross-border operations create FX and regulatory exposure
The company’s central strategy is to advance Trappsol® Cyclo™ through pivotal clinical development and, if successful,...
01
Complete Trappsol® Cyclo™ clinical developmentshort-term
The lead asset is the main value driver and the clearest path to future commercialization.
02
Focus capital on core healthcare holdingsmedium-term
The company manages multiple subsidiaries and needs to direct resources toward the most promising programs.
03
Build value through selective strategic investmentslong-term
The holding-company structure allows participation in additional therapeutics and device opportunities.
Rafael Holdings is exposed to clinical, regulatory, financing, and concentration risks typical of early-stage biotech...
Need for additional capital
Late-stage clinical development and potential commercialization require substantial funding.
- Scope
- Trappsol® Cyclo™ and broader portfolio development
- Materiality
- high
Customer concentration
A small number of customers account for a substantial portion of revenue.
- Scope
- Cyclodextrin research product sales
- Materiality
- high
Supplier dependence
The company relies on third-party suppliers and manufacturers for key inputs and production.
- Scope
- Trappsol® products and Aquaplex® products
- Materiality
- high
Foreign exchange and cross-border disruption
Purchases and operations span multiple countries and currencies.
- Scope
- U.S., Japan, China, Europe, and Israel
- Materiality
- medium
Research and development expense
Affects operating loss and comparability across periods
Consolidation of subsidiaries
Can materially alter revenue, expenses, and segment mix
Impairment of long-lived assets
Could create non-cash charges and reduce carrying values
Fair value measurements
Can affect gains, losses, and balance-sheet carrying amounts
: 29.4.2026