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Rafael Holdings (RFL) is a diversified holding company focused on clinical stage therapeutics, infusion technology, and strategic real estate. This page serves as your centralized source for official news, press releases, and updates across all business segments.
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Rafael Holdings (NYSE: RFL) announced CEO Bill Conkling will step down and transition to an advisory role, with Executive Chairman Howard Jonas assuming the CEO position. The change follows Rafael's merger with Cyclo Therapeutics, transforming Rafael into a late-stage clinical biotechnology company.
The company's focus is now on Trappsol® Cyclo™, a potential treatment for Niemann-Pick Disease Type C1 (NPC1), a rare and fatal genetic disorder. The TransportNPC™ Phase 3 clinical trial is fully enrolled, with 48-week interim analysis results expected in mid-2025.
Rafael Holdings (NYSE: RFL) has completed its merger with Cyclo Therapeutics following shareholder approvals from both companies. The merger terms included Rafael Holdings issuing Class B common stock to Cyclo Therapeutics' shareholders, representing approximately 22% of the combined company, with an exchange ratio of 0.3525.
The company's lead clinical asset, Trappsol® Cyclo™, is currently in a Phase 3 clinical trial (TransportNPC™) for treating Niemann-Pick Disease Type C1, a rare and fatal genetic disease. The trial is fully enrolled, with 48-week interim analysis results expected in mid-2025. The study is designed as a prospective, randomized, double-blind, placebo-controlled, multi-center therapeutic study in pediatric and adult patients.
Rafael Holdings (NYSE: RFL) reported Q2 fiscal 2025 financial results, highlighting its pending merger with Cyclo Therapeutics expected to close in Q3 2025. The company reported cash and cash equivalents of $48.3 million as of January 31, 2025.
The company recorded a net loss of $4.6 million ($0.19 per share) in Q2, compared to net income of $6.0 million ($0.25 per share) in the previous year. The decline was primarily due to unrealized losses of $1.1 million on Cyclo investments. For the first six months of fiscal 2025, net loss was $13.6 million ($0.57 per share).
Post-merger, Rafael will focus on Cyclo's lead clinical program Trappsol® Cyclo™, with topline data from a Phase 3 study in Niemann-Pick Disease Type C1 expected mid-2025. R&D expenses increased to $0.9 million in Q2 FY25 from $0.6 million year-over-year, while G&A expenses remained stable at $2.6 million.
Rafael Holdings (NYSE: RFL) reported Q1 fiscal 2025 financial results, highlighting its pending merger with Cyclo Therapeutics expected to close in Q1 2025. The company reported cash and equivalents of $54.3 million and a net loss of $9.0 million ($0.37 per share), compared to a $3.6 million loss ($0.15 per share) in the prior year.
The increased losses were mainly due to $6.0 million in unrealized losses on Cyclo investments and convertible notes. R&D expenses rose to $1.3 million from $0.5 million, while G&A expenses increased to $2.5 million from $2.0 million. Post-merger, Rafael will focus on Trappsol® Cyclo™, currently in a fully enrolled Phase 3 study for Niemann-Pick Disease Type C1, with interim results expected mid-2025.
Rafael Holdings (NYSE: RFL) reported its Q4 and FY2024 financial results, highlighting a merger agreement with Cyclo Therapeutics. The company ended with $65.9 million in cash and equivalents. Q4 showed a net loss of $4.5 million ($0.19/share), compared to a gain of $1.3 million in the prior year. FY2024 resulted in a net loss of $34.4 million ($1.45/share), largely due to an $89.9 million R&D expense from the Cornerstone acquisition, partially offset by a $31.3 million receivables recovery. The company increased its stake in Day Three Labs to 84% and began consolidating financial results for both Day Three Labs and Cornerstone Pharmaceuticals.
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.