Rafael Holdings — Fiscal Year 2026 Earnings Summary

Financial Performance:

• Reported a net loss of $9.2 million ($0.18 per share) for the quarter ended July 31, 2026, compared to a net loss of $12.1 million ($0.28 per share) in the prior year period.
• Reported a net loss of $29.6 million ($0.58 per share) for the full fiscal year 2026, compared to a net loss of $30.5 million ($1.04 per share) in the prior year.
• Revenue for the quarter was $244,000, down from $350,000 in the prior year; full-year revenue was $874,000, down from $917,000.
• Research and development expenses were $7.5 million for the quarter (unchanged from prior year) and $24.3 million for the full year (up from $12.8 million).
• General and administrative expenses were $2.4 million for the quarter (down from $5.5 million) and $9.7 million for the full year (down from $13.8 million).
• Cash and cash equivalents totaled $22.1 million as of July 31, 2026, down from $52.8 million in the prior year.
• Total assets were $83.1 million as of July 31, 2026, down from $114.1 million in the prior year.
• Total liabilities were $11.1 million as of July 31, 2026, down from $15.7 million in the prior year.
• A $4.4 million gain on Cornerstone's settlements of accounts payable and convertible notes payable contributed to the full-year loss reduction.

Business Segments and Product Lines:

• Submitted a New Drug Application (NDA) to the FDA on October 28, 2026, for remibetadex (Trappsol® Cyclo™) to treat Niemann-Pick Disease Type C.
• The NDA is supported by the Phase 3 TransportNPC™ study, which did not meet its primary endpoint in the overall population (p=0.19) but showed a 71% slowing of disease progression in a prespecified analysis of patients receiving background miglustat and/or leucine therapy (p=0.046).
• The NDA includes a request for a rare pediatric disease priority review voucher.
• Entered an exclusive, worldwide license with MIT in April 2026 for the use of hydroxypropyl-β-cyclodextrin in Alzheimer's disease.
• Launched an investigator-initiated Phase II trial of Promitil® with radiotherapy in cisplatin-ineligible head and neck cancer patients in Israel in June 2026.
• Continued the U.S. commercial build-out of the FDA-cleared VECTR™ System, including its regional distributor network.

Risks and Challenges:

• The Phase 3 TransportNPC™ study did not meet its primary endpoint in the overall population.
• There is substantial doubt about the company's ability to continue as a going concern.
• The company faces a need for additional financing.
• Forward-looking statements regarding FDA acceptance, priority review, approval, or monetization of the priority review voucher involve known risks and uncertainties.

Management Commentary and Tone:

• Management noted the year-over-year decrease in net loss was largely attributable to a decrease in general and administrative expenses.
• The full-year decrease in net loss reflected a $4.4 million gain on settlements and the absence of prior-year unrealized losses on the investment in Cyclo, partially offset by higher R&D expenses following the consolidation of Cyclo Therapeutics in March 2025.
• The decrease in G&A expenses was primarily due to decreases in payroll, stock-based compensation expense, and professional fees.

Other Key Points:

• The company holds interests in clinical and early-stage pharmaceutical development companies and an orthopedic-focused medical device company.
• The NDA submission includes a request for a rare pediatric disease priority review voucher.
• The company consolidated Cyclo Therapeutics in March 2025, leading to increased R&D expenses in fiscal 2026.