Rafael Holdings Stock Price, News & Analysis

Rafael Holdings (NYSE: RFL) and Cyclo Therapeutics (Nasdaq: CYTH) have entered into a definitive merger agreement to combine their efforts in developing Trappsol® Cyclo™ for Niemann-Pick Disease Type C1 treatment. The merger involves Rafael Holdings issuing Class B common stock to Cyclo Therapeutics shareholders, valuing Cyclo shares at $0.95 each. Rafael Holdings will fund Cyclo's operations through closing and support the TransportNPC™ clinical trial to its 48-week interim analysis.

The merger, expected to close in late 2024, is subject to shareholder approvals and other conditions. Cyclo Therapeutics recently completed enrollment in its pivotal TransportNPC™ Phase 3 clinical study, with results from the 48-week interim analysis expected in mid-2025. This merger represents a significant step in Rafael Holdings' strategy to invest in and develop clinical-stage assets for high unmet medical needs.

Rafael Holdings (NYSE: RFL) has announced its financial results for the third quarter and first nine months of fiscal 2024, ending April 30, 2024. The company reported a net loss from continuing operations of $32.4 million for the quarter, or $1.36 per diluted share, compared to a net loss of $1.4 million in the same period last year. This loss was primarily driven by an $89.9 million in-process R&D expense, partially offset by a $31.3 million recovery of receivables from Cornerstone. For the nine months ending April 30, 2024, the net loss was $29.9 million, or $1.26 per diluted share, compared to $9.6 million in the previous year. The company highlighted positive developments, including the completion of enrollment in Cyclo Therapeutics' Phase 3 study and revenue generation at Day Three Labs. Cash and cash equivalents stood at $72.4 million as of April 30, 2024. General and administrative expenses decreased to $1.9 million for the quarter, down from $2.3 million last year.

Cyclo Therapeutics has completed enrollment for its Phase 3 TransportNPC™ trial, the largest study of its kind for Niemann-Pick Disease Type C1 (NPC1). The study includes 104 patients and aims to evaluate the efficacy of Trappsol® Cyclo™ in treating systemic and neurological symptoms of NPC1.

Topline data from the 48-week interim analysis is expected in the first half of 2025. Positive results could lead to the submission of a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the EMA in the second half of 2025.

The trial also features a substudy for newborns to 3-year-olds, targeting early-stage interventions. The company has received Orphan Drug Designation in both the U.S. and EU, Fast Track and Rare Pediatric Disease designations in the U.S., which could qualify them for a Priority Review Voucher.