Trappsol Cyclo™
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Rafael Holdings Reports Second Quarter Fiscal 2026 Financial Results
Globenewswire· 2026-03-16 20:01
Core Viewpoint - Rafael Holdings, Inc. reported its financial results for the second quarter of fiscal year 2026, highlighting ongoing clinical trials and financial performance, including increased net losses attributed to the consolidation of Cyclo Therapeutics' expenses following its acquisition. Financial Performance - As of January 31, 2026, the company had cash and cash equivalents of $37.8 million [4] - For the three months ended January 31, 2026, the net loss attributable to Rafael Holdings was $6.4 million, or $0.13 per share, compared to a net loss of $4.6 million, or $0.19 per share in the same period last year [5] - Research and development expenses for the same period were $4.5 million, up from $0.9 million year-over-year, primarily due to the inclusion of Cyclo's expenses [6] - General and administrative expenses were $2.3 million, a decrease from $2.6 million in the prior year, attributed to reduced payroll and professional fees [7] - For the six months ended January 31, 2026, the net loss was $16.2 million, or $0.32 per share, compared to a net loss of $13.6 million, or $0.57 per share in the previous year [8] Clinical Development - The company is progressing with its pivotal Phase 3 TransportNPC™ study evaluating Trappsol Cyclo™ for Niemann-Pick Disease Type C1, with the Data Monitoring Committee recommending continuation after reviewing safety and efficacy data at 48 weeks [2] - The Phase 3 clinical trial is the largest ever conducted for this indication, with preliminary top-line results expected in the third quarter of 2026 [3] Company Overview - Rafael Holdings, Inc. is a biotechnology company focused on developing pharmaceuticals and holding interests in clinical and early-stage companies [11] - The lead candidate, Trappsol Cyclo™, is under evaluation for the treatment of Niemann-Pick Disease Type C1, a rare and fatal genetic disorder [11]
Rafael Holdings Reports Fourth Quarter and Full Year Fiscal 2025 Financial Results
Globenewswire· 2025-10-29 20:24
Core Insights - The pivotal Phase 3 clinical trial for Trappsol Cyclo™ is ongoing, with positive recommendations from the Data Monitoring Committee [1][2] - The company successfully closed a $25 million rights offering, enhancing its financial position to support the Trappsol Cyclo™ program and other opportunities [2] - Rafael Holdings reported a net loss of $12.1 million for Q4 FY 2025, an increase from a net loss of $4.5 million in the same period last year, primarily due to the consolidation of Cyclo Therapeutics' expenses [4][5] Financial Performance - As of July 31, 2025, the company had cash and cash equivalents of $52.8 million, following the $25 million rights offering closed in June 2025 [3] - For the three months ended July 31, 2025, research and development expenses rose to $7.5 million from $1.5 million year-over-year, reflecting increased spending at Cyclo Therapeutics [5] - General and administrative expenses for the same period were $5.5 million, up from $2.3 million in the prior year, also due to the inclusion of Cyclo's expenses [6] Yearly Overview - For the full fiscal year 2025, Rafael Holdings recorded a net loss of $30.5 million, an improvement from a net loss of $34.4 million in the previous year [7] - Research and development expenses for the full year were $12.8 million, compared to $4.2 million in the prior year, driven by the acquisition of Cyclo Therapeutics [8] - General and administrative expenses for the full year increased to $13.8 million from $8.9 million, attributed to the consolidation of Cyclo and other entities [9][10] Company Background - Rafael Holdings, Inc. is a biotechnology company focused on developing pharmaceuticals, with its lead candidate Trappsol® Cyclo™ aimed at treating Niemann-Pick Disease Type C1 [11]
Rafael Holdings Announces Abstracts Accepted for Oral and Poster Presentations at the 15th International Congress of Inborn Errors of Metabolism (ICIEM)
Globenewswire· 2025-08-27 12:00
Core Viewpoint - Rafael Holdings, Inc. announced that its subsidiary Cyclo Therapeutics will present two abstracts on Trappsol Cyclo™ for Niemann-Pick Disease Type C1 at the upcoming ICIEM conference in Kyoto, Japan [1] Group 1: Presentation Details - The first presentation will be an oral session titled "Hydroxypropyl-beta-cyclodextrin for the Long-Term Treatment of Niemann Pick Type C1: Efficacy and Safety Data from 4 Clinical Studies and the Ongoing Expanded Access Program" by Dr. Caroline Hastings on September 3, 2025 [1] - The second presentation will be a poster session titled "Trappsol Cyclo Open Label Treatment in the TransportNPC Sub-Study in Patients Under the Age of 3 Diagnosed with Niemann Pick Disease Type C1" by Dr. Orna Staretz Chacham on the same day [1] Group 2: About Trappsol Cyclo™ - Trappsol Cyclo™ is a first-in-class proprietary cyclodextrin formulation administered intravenously that mobilizes lysosomal cholesterol, targeting the root cause of Niemann-Pick Disease Type C1 [2] - It has been shown to cross the blood-brain barrier, suggesting therapeutic concentrations in the central nervous system [2] Group 3: Study Program - The Phase 3 TransportNPC study is a randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of Trappsol Cyclo™ in patients aged 3 years and older, with a total enrollment of 94 patients across 25 sites in 13 countries [3] - The study duration is 96 weeks, with an interim analysis recommending continuation after 48 weeks [3] Group 4: Disease Overview - Niemann-Pick Disease Type C1 is a rare genetic disorder affecting approximately 1 in 100,000 live births, characterized by cholesterol accumulation leading to organ damage and life-limiting symptoms [8] - About 95% of individuals with NPC have mutations in the NPC1 gene, while 5% have mutations in the NPC2 gene [8] Group 5: Company Overview - Rafael Holdings, Inc. is a biotechnology company with a focus on developing treatments for rare and neurodegenerative diseases, including a 100% interest in Cyclo Therapeutics [9] - Cyclo Therapeutics is dedicated to developing Trappsol Cyclo™ for Niemann-Pick Disease Type C1 and is conducting multiple clinical trials for this indication [10]
Rafael Holdings, Inc. Announces Final Results and Closing of Rights Offering
Globenewswire· 2025-06-04 20:01
Core Viewpoint - Rafael Holdings, Inc. successfully completed a $25 million rights offering, raising approximately $4 million through subscriptions for Class B common stock, with additional funding expected from a backstop private placement by CEO Howard Jonas [1][4]. Group 1: Rights Offering Details - The rights offering resulted in subscriptions for 3,130,480 shares of Class B common stock at an exercise price of $1.28 per share, generating gross proceeds of $4,007,014.40 [1]. - The subscription period ended on May 29, 2025, and shares were issued to participating stockholders on June 4, 2025 [2]. - Howard Jonas and his affiliates, holding about 32% of the company's outstanding common stock, did not exercise their subscription rights due to a commitment to backstop the offering [1][3]. Group 2: Financial Implications - The net proceeds from the rights offering and the backstop private placement are expected to be approximately $24.9 million after deducting related expenses [4]. - Following these transactions, the company anticipates having around 50,879,164 shares of Class B common stock and 787,163 shares of Class A common stock outstanding [5]. Group 3: Strategic Use of Proceeds - The proceeds from the rights offering will provide additional capital for regulatory approval efforts and the potential launch of Trappsol Cyclo™ pending positive interim results from the ongoing Phase 3 clinical trial for Niemann-Pick Disease Type C1 [3]. Group 4: Company Overview - Rafael Holdings, Inc. is involved in clinical and early-stage pharmaceutical companies, focusing on developing Trappsol Cyclo™ for Niemann-Pick Disease Type C1, along with other pharmaceutical and medical device ventures [7].