Rafael Holdings, Inc. filings document regulatory disclosures for a biotechnology company with Class B common stock listed on the New York Stock Exchange. The company’s reports include Form 8-K earnings releases, Regulation FD disclosures, clinical and intellectual-property updates tied to Cyclo Therapeutics, and material-event reporting related to its pharmaceutical development activities.
Proxy and meeting filings describe board elections, auditor ratification, equity incentive plan matters, committee governance and shareholder voting results. Securities-related filings cover Rafael’s Class B common stock, warrants to purchase Class B common stock, warrant exchange matters connected to the Cyclo Therapeutics merger, and Form 25 listing and registration notices for the warrant class.
Rafael Holdings, Inc. reported that subsidiary Cyclo submitted a New Drug Application on October 28, 2026, seeking approval of Trappsol® Cyclo™ for Niemann-Pick Disease Type C in adult and pediatric patients from birth. The pivotal Phase 3 study enrolled 94 patients but did not meet its primary endpoint in the overall population; a prespecified analysis of patients receiving background miglustat and/or leucine showed a statistically significant treatment benefit. Within 60 days of receipt, FDA will determine whether the application is complete and acceptable for filing and, if accepted, whether Priority Review will be granted.
Fiscal 2026 consolidated net loss was $27.954 million, compared with $30.643 million in fiscal 2025; net cash used in operating activities was $29.987 million, versus $18.924 million. Cash and cash equivalents were $22.074 million and working capital $14.830 million as of July 31, 2026. Recurring losses led management to conclude substantial doubt exists about Rafael’s ability to continue as a going concern for at least 12 months from issuance. The company depends on additional capital, with no assurance funding will be available on acceptable terms or at all.
Management also said internal control over financial reporting was ineffective as of July 31, 2026, because Cyclo’s material weakness in accrual and related expense controls remained unremediated.
Rafael Holdings, Inc. reported fiscal 2026 results and said subsidiary Cyclo Therapeutics, LLC submitted an NDA to the FDA seeking approval of remibetadex for the neurovisceral manifestations of Niemann-Pick disease type C (NPC) in patients from birth. Cash and cash equivalents were $22.1 million as of July 31, 2026. Fourth-quarter net loss attributable to Rafael Holdings was $9.2 million versus $12.1 million a year earlier; full-year net loss was $29.6 million versus $30.5 million.
The TransportNPC Phase 3 study did not achieve statistical significance on its primary endpoint; remibetadex showed a directionally favorable 64% relative slowing of disease progression versus placebo (p=0.19). A prespecified analysis of patients receiving background therapy reported 71% relative slowing (p=0.046). A survival analysis associated remibetadex with an 85% reduction in mortality risk for patients with infantile-onset NPC versus matched registry controls (p=0.044). Serious adverse events occurred in 35.9% with remibetadex and 16.7% with placebo.
Within 60 days of receiving the NDA, the FDA will determine whether it is filed and, if filed, whether Priority Review is granted; if filed, the agency will assign a PDUFA target action date. Remibetadex remains investigational and has not been FDA-approved. Rafael cited a need for additional financing and substantial doubt about its ability to continue as a going concern.
Rafael Holdings, Inc. (RFL) Chief Financial Officer David Polinsky had 4,245 Class B common shares withheld by the issuer for tax purposes upon restricted stock vesting on October 25, 2026. After the transaction, he reported 292,839 shares, consisting of 189,089 shares held directly and 103,750 unvested restricted shares.
Rafael Holdings, Inc. (RFL) reported topline results from its subsidiary Cyclo Therapeutics’ pivotal Phase 3 TransportNPC study of Trappsol Cyclo in 94 patients with Niemann-Pick disease type C. At Week 96, the treatment showed a directionally favorable effect on the primary 4-domain NPC Clinical Severity Scale endpoint, but did not achieve statistical significance. A prespecified analysis of patients receiving background miglustat and/or leucine—approximately 83% of participants—showed a statistically significant effect.
Over 96 weeks, serious treatment-emergent adverse events were reported in 35.9% of Trappsol Cyclo participants versus 16.7% on placebo; treatment-related serious events were 3.1% versus 3.3%. No treatment-emergent adverse events resulted in death, and one treatment-related case of bilateral deafness was severe. A separate analysis comparing infantile-onset patients treated across the clinical program with matched external registry controls was described as supportive evidence of a treatment-associated survival benefit. Rafael said it remains on track to submit an NDA in the fourth quarter of 2026 following a previously announced pre-NDA meeting; the topline data, complete dataset and survival analysis remain subject to full analysis and FDA regulatory review.
Rafael Holdings, Inc. (RFL) Chief Financial Officer David Polinsky had 2,027 Class B shares withheld by the issuer for tax purposes upon vesting of Restricted Stock on September 21, 2026, at a reported price of $2.025 per share. He reported 297,084 Class B shares following the transaction, consisting of 183,334 shares held directly and 113,750 unvested restricted shares. No Rule 10b5-1 plan is reported.
JONAS HOWARD S reported acquisition or exercise transactions in this Form 4 filing.
Rafael Holdings executive Howard S. Jonas received a grant of 54,945 restricted Class B Common shares on July 29, 2026 at $2.73 per share. The award vests in four tranches between September 13, 2026 and June 13, 2027.
After this grant he holds 512,030 Class B shares directly, consisting of 239,228 vested and 272,802 unvested restricted shares, with additional tranches scheduled to vest through January 13, 2030. He also reports indirect holdings of Class A and Class B shares through The Jonas Foundation, multiple trusts, and limited partnerships over which he has varying degrees of control.
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.