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Rafael Holdings, Inc. furnished an investor presentation outlining progress of its lead drug candidate Trappsol® Cyclo for Niemann-Pick Disease Type C1 (NPC). The company is running a fully enrolled, global Phase 3 trial with 104 subjects in a 96-week study using 2000 mg/kg intravenous dosing every two weeks.
The Phase 3 interim analysis at 48 weeks in June 2025 led an independent data monitoring committee to recommend continuation to the 96-week final analysis. Last-patient-last-visit and a pre-NDA meeting were completed in June 2026, and the company expects New Drug Application submission and topline Phase 3 data in the second half of 2026.
The presentation highlights prior Phase 1/2 data showing stabilized or improved clinical scores in most completers, a safety profile characterized mainly by mild to moderate adverse events, and regulatory designations including Orphan Drug status in the US and EU, Fast Track in the US, and Rare Pediatric Disease designation that may qualify for a Priority Review Voucher. It also cites estimates that the global NPC market could exceed $920m by 2031.
Rafael Holdings, Inc. Chief Financial Officer David Polinsky reported a routine tax-related share withholding. On the vesting of restricted stock, the company withheld 2,386 shares of Class B common stock at $2.635 per share to cover tax obligations, rather than selling shares in the open market.
After this withholding, Polinsky directly and through restricted stock holds a total of 299,111 Class B shares. This includes 76,882 shares held outright, 102,229 fully vested restricted shares, and 120,000 unvested restricted shares scheduled to vest in tranches through 2030.
Rafael Holdings, Inc. reported a new equity award and related tax withholding for its Executive Chairman, CEO and President Howard S. Jonas. On June 13, 2026, he received a grant of 142,857 shares of Class B Common Stock as restricted stock at $1.75 per share. The company withheld 8,786 Class B shares at $2.33 per share to cover tax obligations upon vesting of restricted stock, a non-market disposition. After these updates, Jonas holds 314,228 shares of Class B Common Stock directly, consisting of 239,228 vested restricted shares and 75,000 unvested restricted shares with scheduled vesting through January 2030, and also has substantial indirect holdings through partnerships, trusts and a foundation.
Rafael Holdings reported results for the quarter and nine months ended April 30, 2026, showing a small revenue base and ongoing investment in biotech programs. Total revenue was $179,000 for the quarter and $630,000 for the nine-month period, primarily from rental and product sales.
The company posted a quarterly net loss attributable to Rafael Holdings of $4.2 million and a nine-month net loss of $20.5 million, or $(0.40) per share. Cash and cash equivalents were $30.5 million, down from $52.8 million at prior year-end, after using $21.6 million in operating cash over nine months, largely to fund R&D on lead drug candidate Trappsol® Cyclo™ and other portfolio companies.
Rafael Holdings, Inc. reported third quarter fiscal 2026 results and highlighted a major clinical milestone: completion of the last patient last visit in its pivotal Phase 3 TransportNPC™ trial in Niemann-Pick Disease Type C1. Following a pre-NDA meeting, the company expects to submit an NDA in the second half of calendar 2026.
For the quarter ended April 30, 2026, Rafael Holdings posted a net loss attributable to the company of $4.2 million, or $0.08 per share, compared with a $4.8 million loss, or $0.19 per share, a year earlier. Revenue was $0.2 million versus $0.4 million in the prior-year quarter. Research and development expenses rose to $4.9 million from $3.0 million, reflecting the Cyclo acquisition, while general and administrative costs declined to $2.1 million from $3.2 million. As of April 30, 2026, the company held $30.5 million in cash and cash equivalents and total assets of $92.0 million.
Rafael Holdings, Inc. announced that the last patient has completed the final 96‑week visit in its pivotal Phase 3 TransportNPC™ study of Trappsol® Cyclo™ for Niemann‑Pick Disease Type C. The trial enrolled 94 patients across 27 sites in 13 countries, plus a 10‑patient pediatric sub‑study.
Topline data from the main study cohort are expected in the second half of 2026. The company has already held a pre‑NDA meeting with the FDA and expects to submit a New Drug Application in the second half of 2026. The FDA has also acknowledged that the company’s U.S. Expanded Access Program can proceed.
Rafael Holdings announced that its subsidiary Cyclo Therapeutics has entered into an exclusive licensing agreement with MIT for U.S. Patent No.12285440, covering the use of cyclodextrins in Alzheimer’s Disease patients who carry the ApoE4 genetic mutation.
The company plans to apply this patent to its lead candidate Trappsol® Cyclo™, which is already in a pivotal Phase 3 trial for Niemann-Pick Disease Type C1. The ApoE4 gene variant is estimated to be present in 50-70% of Alzheimer’s patients, and the release highlights preclinical data suggesting Trappsol® Cyclo™ may improve cholesterol transport in the brain, reduce tau pathology, and improve learning and memory in mice. Management also notes Phase 3 results from the Transport NPC study are expected in calendar Q3 2026.
Rafael Holdings, Inc. Chief Financial Officer David Polinsky reported a tax-related share disposition. On the vesting of restricted stock, 2,318 shares of Class B common stock were withheld by the company to cover tax obligations, rather than being sold on the open market.
After this withholding, Polinsky directly and indirectly holds a total of 301,497 shares, consisting of 76,882 shares held directly, 98,365 fully vested restricted shares and 126,250 unvested restricted shares that vest in scheduled installments through 2030. This filing reflects routine compensation and tax treatment rather than a discretionary trade.
Rafael Holdings, Inc. executive chairman, CEO and president Howard S. Jonas reported a Form 4 showing 9,826 shares of Class B common stock withheld by the company at $1.5025 per share to cover taxes upon the vesting of restricted stock. This is recorded as a tax-withholding disposition rather than an open-market trade.
After this event, he directly holds 323,014 Class B shares, consisting of 218,365 vested restricted shares and 104,649 unvested restricted shares that are scheduled to vest in tranches through 2030. He also reports substantial indirect holdings through entities including The Jonas Foundation, the Debbie Y. Jonas 2018 Dynasty Trust, the HSJ 2019 Remainder Trust, and several limited partnerships.
Rafael Holdings, Inc. reported a larger operating loss as it advances its biotech strategy. For the six months ended January 31, 2026, revenue was $451 thousand, up from $205 thousand a year earlier, driven mainly by rental and new product sales, but research and development expense rose to $12.0 million from $2.3 million. Net loss attributable to Rafael Holdings widened to $16.2 million, or $0.32 per share, compared with $13.6 million, or $0.57 per share. Cash and cash equivalents were $37.8 million as of January 31, 2026, down from $52.8 million at prior fiscal year-end, after using $14.3 million in operating cash during the period. Total assets were $99.3 million and equity was $83.3 million, reflecting significant goodwill and in-process R&D tied to its acquisition of Cyclo and lead drug candidate Trappsol® Cyclo™. The company states its cash is expected to cover obligations for at least 12 months while it focuses on completing a pivotal Phase 3 trial in Niemann-Pick Disease Type C1 and managing a portfolio of majority-owned life science businesses.