Rafael Holdings, Inc. Class B - RFL STOCK NEWS

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.

Rafael Holdings, Inc. (NYSE: RFL) reports financial results for Q2 fiscal 2024, showing a net income of $5.9 million and increased ownership in Day Three Labs to 79%. The company aims to enhance shareholder value through strategic investments and portfolio advancement, welcoming Dr. John Goldberg as Chief Medical Officer. Notable progress in Cyclo Therapeutics' Phase 3 trial for Niemann-Pick Disease Type C and Day Three Labs' innovative cannabis products development.

Rafael Holdings, Inc. (NYSE: RFL) reported its Q1 fiscal 2024 results, emphasizing a focus on advancing the portfolio and identifying strategic investments. The company holds $72.1 million in cash, cash equivalents, and marketable securities. It reported a net loss of $3.8 million, down from $5.2 million a year ago. Research and development expenses decreased to $0.5 million from $2.1 million, while general and administrative expenses decreased to $2.0 million from $3.1 million.

Cyclo Therapeutics, Inc. (Nasdaq: CYTH) reported strong enrollment in its pivotal Phase 3 global study evaluating Trappsol® Cyclo™ for Niemann-Pick Disease Type C1 (“NPC1”). The company is also on track to close a merger with Applied Molecular Transport, Inc. before the year ends. Additionally, they have taken steps to strengthen their balance sheet and extend their cash position.

Rafael Holdings, Inc. reported its financial results for Q4 and full year fiscal 2023. They curtailed expenses and increased liquidity by selling their real estate. They invested in Cyclo Therapeutics and Day Three Laboratories. They had cash and marketable securities of $79.2 million as of July 31, 2023. Net income from continuing operations for Q4 was $1.3 million, compared to a net loss of $4.6 million in the same period last year. R&D expenses decreased from $1.8 million to $1.3 million. General and administrative expenses decreased from $3.0 million to $1.4 million.

Cyclo Therapeutics reports strong enrollment progress in pivotal Phase 3 study for Niemann-Pick Disease Type C1

Cyclo Therapeutics closes private placement with Rafael Holdings for $5,000,000, to be used for working capital and Trappsol® Cyclo™ development programs.