Rafael Holdings Completes Merger with Cyclo Therapeutics Following Shareholder Approvals
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) ha completato la sua fusione con Cyclo Therapeutics dopo l'approvazione degli azionisti di entrambe le aziende. I termini della fusione prevedono che Rafael Holdings emetta azioni ordinarie di Classe B agli azionisti di Cyclo Therapeutics, che rappresentano circa il 22% della società combinata, con un rapporto di scambio di 0,3525.
Il principale asset clinico dell'azienda, Trappsol® Cyclo™, è attualmente in fase di sperimentazione clinica di Fase 3 (TransportNPC™) per il trattamento della malattia di Niemann-Pick di tipo C1, una malattia genetica rara e fatale. La sperimentazione è completamente arruolata, con risultati dell'analisi intermedia a 48 settimane attesi per metà del 2025. Lo studio è progettato come uno studio terapeutico prospettico, randomizzato, in doppio cieco, controllato con placebo e multicentrico, in pazienti pediatrici e adulti.
Rafael Holdings (NYSE: RFL) ha completado su fusión con Cyclo Therapeutics tras la aprobación de los accionistas de ambas compañías. Los términos de la fusión incluyen que Rafael Holdings emita acciones ordinarias de Clase B a los accionistas de Cyclo Therapeutics, representando aproximadamente el 22% de la empresa combinada, con una relación de intercambio de 0.3525.
El principal activo clínico de la compañía, Trappsol® Cyclo™, se encuentra actualmente en un ensayo clínico de Fase 3 (TransportNPC™) para el tratamiento de la enfermedad de Niemann-Pick Tipo C1, una enfermedad genética rara y fatal. El ensayo está completamente reclutado, con resultados del análisis intermedio a 48 semanas esperados para mediados de 2025. El estudio está diseñado como un estudio terapéutico prospectivo, aleatorizado, doble ciego, controlado con placebo y multicéntrico, en pacientes pediátricos y adultos.
라파엘 홀딩스 (NYSE: RFL)는 두 회사의 주주 승인을 받은 후 사이클로 테라퓨틱스와의 합병을 완료했습니다. 합병 조건에는 라파엘 홀딩스가 사이클로 테라퓨틱스의 주주에게 클래스 B 보통주를 발행하는 것이 포함되어 있으며, 이는 합병된 회사의 약 22%를 차지하고, 교환 비율은 0.3525입니다.
회사의 주요 임상 자산인 트랩솔® 사이클로™는 현재 니만-픽 병 C1형 치료를 위한 3상 임상 시험(TransportNPC™)에 있습니다. 이 시험은 완전 등록되었으며, 48주 중간 분석 결과는 2025년 중반에 예상됩니다. 연구는 소아 및 성인 환자를 대상으로 한 전향적, 무작위, 이중 맹검, 위약 대조, 다기관 치료 연구로 설계되었습니다.
Rafael Holdings (NYSE: RFL) a finalisé sa fusion avec Cyclo Therapeutics suite à l'approbation des actionnaires des deux sociétés. Les termes de la fusion incluent l'émission par Rafael Holdings d'actions ordinaires de Classe B aux actionnaires de Cyclo Therapeutics, représentant environ 22% de la société combinée, avec un ratio d'échange de 0,3525.
Le principal actif clinique de l'entreprise, Trappsol® Cyclo™, est actuellement en phase d'essai clinique de Phase 3 (TransportNPC™) pour le traitement de la maladie de Niemann-Pick de type C1, une maladie génétique rare et fatale. L'essai est entièrement inscrit, avec des résultats d'analyse intermédiaire à 48 semaines attendus pour mi-2025. L'étude est conçue comme une étude thérapeutique prospective, randomisée, en double aveugle, contrôlée par placebo et multicentrique, chez des patients pédiatriques et adultes.
Rafael Holdings (NYSE: RFL) hat seine Fusion mit Cyclo Therapeutics nach der Genehmigung durch die Aktionäre beider Unternehmen abgeschlossen. Die Bedingungen der Fusion umfassen, dass Rafael Holdings den Aktionären von Cyclo Therapeutics Aktien der Klasse B ausgibt, die etwa 22% des fusionierten Unternehmens repräsentieren, mit einem Umtauschverhältnis von 0,3525.
Das Haupt-Clinical Asset des Unternehmens, Trappsol® Cyclo™, befindet sich derzeit in einer Phase-3-Studie (TransportNPC™) zur Behandlung der Niemann-Pick-Krankheit Typ C1, einer seltenen und tödlichen genetischen Erkrankung. Die Studie ist vollständig eingeschrieben, und die Ergebnisse der 48-wöchigen Zwischenanalyse werden für Mitte 2025 erwartet. Die Studie ist als prospektive, randomisierte, doppelblinde, placebokontrollierte, multizentrische therapeutische Studie bei pädiatrischen und erwachsenen Patienten konzipiert.
- Fully enrolled Phase 3 clinical trial for rare disease treatment
- Strategic merger strengthens company's position in rare disease therapeutics
- Advanced-stage clinical asset targeting high unmet medical need
- Results from important Phase 3 trial not expected until mid-2025
- 22% dilution for existing RFL shareholders
Insights
Rafael Holdings' completed merger with Cyclo Therapeutics represents a strategic pipeline expansion in the rare disease space. The transaction structure gives Cyclo shareholders approximately 22% of the combined entity with an exchange ratio of 0.3525, while Rafael gains full control of Trappsol® Cyclo™, a Phase 3 asset targeting Niemann-Pick Disease Type C1.
This merger culminates what appears to be a two-year partnership between the companies, demonstrating Rafael's commitment to building a portfolio addressing high unmet medical needs. The fully enrolled TransportNPC™ trial positions the combined company at a critical inflection point, with the 48-week interim analysis expected mid-2025 serving as the next major catalyst.
For Rafael, this transaction transforms its clinical pipeline with a late-stage asset targeting a fatal genetic disorder with treatment options. The deal's timing is particularly strategic as it secures the asset before the interim data readout, potentially capturing significant value if results prove positive.
While financial terms beyond the exchange ratio aren't disclosed, the successful closing removes deal uncertainty and allows management to focus on clinical execution. The combined entity now faces primarily clinical rather than transactional risk, with the Phase 3 interim results representing the most significant near-term value driver.
The acquisition of Cyclo Therapeutics gives Rafael Holdings control of a significant late-stage asset in the orphan drug space. Trappsol® Cyclo™ targets Niemann-Pick Disease Type C1 (NPC1), a rare lysosomal storage disorder characterized by progressive neurological deterioration with treatment options.
The TransportNPC™ trial design is particularly robust—a multinational, randomized, double-blind, placebo-controlled study encompassing both pediatric and adult patients. Having achieved full enrollment is a notable accomplishment in a rare disease where patient recruitment is typically challenging. This suggests effective site selection and protocol design.
The 48-week interim analysis will be pivotal, as it should provide sufficient data to evaluate both safety and preliminary efficacy signals. For Rafael shareholders, this represents a well-defined catalyst in mid-2025. NPC1's progressive nature means that showing disease modification or even stabilization could be clinically meaningful.
Should Trappsol® Cyclo™ demonstrate efficacy, Rafael would hold a valuable asset in the orphan drug landscape, where approved therapies can command premium pricing due to small patient populations and high unmet need. The merger's timing—securing the asset before this critical data readout—could prove advantageous for Rafael's valuation if positive results emerge.
Cyclo Therapeutics’ TransportNPC™ Phase 3 clinical trial for Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C1, a rare and fatal genetic disease, is fully enrolled and results from the 48-week interim analysis are expected in the middle of 2025
NEWARK, N.J. and GAINESVILLE, Fla., March 26, 2025 (GLOBE NEWSWIRE) -- Rafael Holdings, Inc. (NYSE: RFL), and Cyclo Therapeutics, Inc. (NASDAQ: CYTH) today announced the closing of their business combination following approval by shareholders of both companies. Rafael Holdings issued shares of its Class B common stock to Cyclo Therapeutics’ shareholders representing approximately
“The merger with Cyclo Therapeutics is a major step forward in our strategy to develop clinical stage assets in areas of high unmet medical need,” said Bill Conkling, President and CEO of Rafael Holdings. Bill added, “We are impressed with the execution of the team in fully enrolling a comprehensive clinical trial in NPC and we eagerly await the interim analysis in the middle of 2025. Rafael Holdings is excited to welcome the talented Cyclo Therapeutics’ team and we are committed to leveraging our resources to help bring Trappsol® Cyclo™ to NPC patients.”
N. Scott Fine, Chief Executive Officer of Cyclo Therapeutics, commented, “We are extremely pleased to announce the completion of our merger with Rafael Holdings and believe that the strength of the combined companies solidifies our commitment to deliver the results of the TransportNPC™ trial for our shareholders and patients suffering from this debilitating and fatal disease. Our partnership with Rafael Holdings during the last two years has enabled Cyclo to get to where we are today and we are thankful to their management team.”
Schwell Wimpfheimer & Associates served as legal advisor to Rafael Holdings and Fox Rothschild LLP served as legal advisor to Cyclo Therapeutics. Cassel Salpeter & Co. acted as financial advisor to the special committee of the Cyclo Therapeutics Board of Directors in connection with the transaction.
About Rafael Holdings, Inc.
Rafael Holdings, Inc. is a biotechnology company with interests in clinical and early-stage pharmaceutical companies including a
About Cyclo Therapeutics, LLC.
Cyclo Therapeutics, LLC. (“Cyclo”) is a wholly owned subsidiary of Rafael Holdings, Inc. (NYSE: RFL). Cyclo is a clinical-stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with disease. The Company’s Trappsol® Cyclo™, an orphan drug designated product in the United States and Europe, is the subject of four formal clinical trials for Niemann-Pick Disease Type C1, a rare and fatal genetic disease, (www.ClinicalTrials.gov NCT02939547, NCT02912793, NCT03893071 and NCT04860960). Cyclo is conducting a Phase 2b clinical trial using Trappsol® Cyclo™ intravenously in early Alzheimer’s disease (NCT05607615) based on encouraging data from an Expanded Access program for Alzheimer’s disease (NCT03624842).
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the potential, safety, efficacy, and regulatory and clinical progress of our product candidates; plans regarding the further evaluation of clinical data; and the potential of our pipeline, including our internal cancer metabolism research programs. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, those disclosed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended July 31, 2024, and our other filings with the SEC. These factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
Contact:
Barbara Ryan
Barbara.ryan@rafaelholdings.com
(203) 274-2825
FAQ
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