Rafael Holdings and Cyclo Therapeutics Enter into a Definitive Merger Agreement
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) e Cyclo Therapeutics (Nasdaq: CYTH) hanno firmato un accordo di fusione definitivo per unire i loro sforzi nello sviluppo di Trappsol® Cyclo™ per il trattamento della Malattia di Niemann-Pick Tipo C1. La fusione comporta l'emissione di azioni ordinarie di Classe B da parte di Rafael Holdings agli azionisti di Cyclo Therapeutics, valutando le azioni di Cyclo a $0,95 ciascuna. Rafael Holdings finanzierà le operazioni di Cyclo fino alla chiusura e supporterà la sperimentazione clinica TransportNPC™ fino alla sua analisi intermedia a 48 settimane.
La fusione, prevista per chiudere entro la fine del 2024, è soggetta all'approvazione degli azionisti e ad altre condizioni. Cyclo Therapeutics ha recentemente completato l'arruolamento nel suo studio clinico cruciale Phase 3 del TransportNPC™, con i risultati dell'analisi intermedia a 48 settimane attesi per metà 2025. Questa fusione rappresenta un passo significativo nella strategia di Rafael Holdings di investire e sviluppare asset in fase clinica per soddisfare esigenze mediche elevate e non soddisfatte.
Rafael Holdings (NYSE: RFL) y Cyclo Therapeutics (Nasdaq: CYTH) han firmado un acuerdo de fusión definitivo para combinar sus esfuerzos en el desarrollo de Trappsol® Cyclo™ para el tratamiento de la Enfermedad de Niemann-Pick Tipo C1. La fusión implica que Rafael Holdings emitirá acciones comunes de Clase B a los accionistas de Cyclo Therapeutics, valorando las acciones de Cyclo en $0.95 cada una. Rafael Holdings financiará las operaciones de Cyclo hasta el cierre y apoyará el ensayo clínico TransportNPC™ hasta su análisis intermedio de 48 semanas.
Se espera que la fusión se cierre a finales de 2024, sujeta a aprobaciones de los accionistas y otras condiciones. Cyclo Therapeutics completó recientemente la inscripción en su estudio clínico crucial de Fase 3 del TransportNPC™, con resultados del análisis intermedio de 48 semanas esperados para mediados de 2025. Esta fusión representa un paso significativo en la estrategia de Rafael Holdings para invertir y desarrollar activos en etapa clínica para satisfacer necesidades médicas no satisfechas.
라파엘 홀딩스 (NYSE: RFL)와 사이클로 테라퓨틱스 (Nasdaq: CYTH)는 최종 합병 계약을 체결했습니다 뇌인형니만-픽병 Type C1 치료를 위한 트랩솔® 사이클로™ 개발에 대한 노력을 결합하기 위해서입니다. 이번 합병으로 라파엘 홀딩스는 사이클로 테라퓨틱스 주주들에게 클래스 B 보통주를 발행하여 사이클로의 주식을 각각 $0.95로 평가합니다. 라파엘 홀딩스는 합병 종료까지 사이클로의 운영을 자금 지원하고, TransportNPC™ 임상 시험을 48주 중간 분석까지 지원할 것입니다.
2024년 말에 종료될 것으로 예상되는 이번 합병은 주주 승인이 필요하며 기타 조건이 따릅니다. 사이클로 테라퓨틱스는 최근 TransportNPC™ 3상 임상 연구의 등록을 완료했으며, 48주 중간 분석 결과는 2025년 중반에 발표될 예정입니다. 이번 합병은 고 unmet medical needs (의료적 필요)을 위한 임상 단계 자산에 투자하고 개발하려는 라파엘 홀딩스의 전략에 있어 중요한 단계입니다.
Rafael Holdings (NYSE: RFL) et Cyclo Therapeutics (Nasdaq: CYTH) ont conclu un accord de fusion définitif pour combiner leurs efforts dans le développement de Trappsol® Cyclo™ pour le traitement de la Maladie de Niemann-Pick Type C1. La fusion implique que Rafael Holdings émette des actions ordinaires de Classe B aux actionnaires de Cyclo Therapeutics, valorisant ainsi les actions de Cyclo à 0,95 $ chacune. Rafael Holdings financera les opérations de Cyclo jusqu'à la clôture et soutiendra l'essai clinique TransportNPC™ jusqu'à son analyse intermédiaire de 48 semaines.
La fusion, prévue pour être finalisée fin 2024, est soumise à l'approbation des actionnaires et à d'autres conditions. Cyclo Therapeutics a récemment terminé l'inscription dans son étude clinique cruciale en Phase 3 du TransportNPC™, avec des résultats de l'analyse intermédiaire de 48 semaines attendus pour mi-2025. Cette fusion représente une étape significative dans la stratégie de Rafael Holdings d'investir et de développer des actifs en phase clinique pour répondre à des besoins médicaux non satisfaits.
Rafael Holdings (NYSE: RFL) und Cyclo Therapeutics (Nasdaq: CYTH) haben eine endgültige Fusionsvereinbarung getroffen, um ihre Bemühungen zur Entwicklung von Trappsol® Cyclo™ zur Behandlung der Niemann-Pick-Krankheit Typ C1 zu bündeln. Die Fusion beinhaltet, dass Rafael Holdings Class-B-Stammaktien an die Aktionäre von Cyclo Therapeutics ausgibt und die Aktien von Cyclo mit $0,95 bewertet. Rafael Holdings wird die Geschäfte von Cyclo bis zum Abschluss finanzieren und die klinische Studie TransportNPC™ bis zu ihrer 48-wöchigen Zwischenanalyse unterstützen.
Die Fusion, die voraussichtlich Ende 2024 abgeschlossen wird, unterliegt den Genehmigungen der Aktionäre und anderen Bedingungen. Cyclo Therapeutics hat kürzlich die Einschreibung in seine entscheidende TransportNPC™ Phase-3-Studie abgeschlossen, mit Ergebnissen der 48-wöchigen Zwischenanalyse, die Mitte 2025 erwartet werden. Diese Fusion stellt einen bedeutsamen Schritt in der Strategie von Rafael Holdings dar, in klinische Entwicklungsanlagen zu investieren und diese für hohe ungedeckte medizinische Bedürfnisse zu entwickeln.
- Merger combines resources to advance Trappsol® Cyclo™ development for Niemann-Pick Disease Type C1
- TransportNPC™ Phase 3 clinical trial fully enrolled, with interim results expected mid-2025
- Rafael Holdings to provide funding support for TransportNPC™ clinical trial
- Strategic alignment to address high unmet medical need in rare genetic disease
- Merger subject to shareholder approvals and other closing conditions
- Cyclo Therapeutics shares valued at $0.95 in the merger, potentially below current market price
- Results from the clinical trial not expected until mid-2025, indicating a long wait for potential commercialization
Insights
This merger between Rafael Holdings and Cyclo Therapeutics represents a significant strategic move in the biotech sector. The deal structure, valuing Cyclo at
The merger's focus on Trappsol® Cyclo™ for Niemann-Pick Disease Type C1 is particularly noteworthy. NPC1 is a rare, fatal genetic disorder with no FDA-approved treatments, representing a significant unmet medical need. The completion of enrollment in the TransportNPC™ Phase 3 trial is a important milestone, as patient recruitment for rare disease studies can be challenging. The 48-week interim analysis in mid-2025 will be a critical inflection point. If positive, it could potentially lead to accelerated approval discussions with regulatory authorities, given the severity of NPC1 and lack of treatment options.
This merger exemplifies a growing trend in the biotech industry where larger companies with strong balance sheets acquire or merge with smaller, clinical-stage biotechs. For Rafael Holdings, this deal transforms it from an investment company into a focused clinical-stage biotech, potentially increasing its appeal to biotech-focused investors. The market for rare disease treatments, while small in patient numbers, can be highly lucrative due to premium pricing. If Trappsol® Cyclo™ proves successful, it could command a high price point, translating to significant revenue potential despite the patient population. Investors should monitor the progress of the Phase 3 trial closely, as it will be the key value driver for the combined entity.
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., Aug. 22, 2024 (GLOBE NEWSWIRE) -- Rafael Holdings, Inc. (NYSE: RFL), and Cyclo Therapeutics, Inc. (Nasdaq: CYTH) today announced that they have entered into a definitive merger agreement to combine the two companies to focus on the development of Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C1. On consummation of the merger, Rafael Holdings will issue shares of its Class B common stock to Cyclo Therapeutics’ shareholders, based on an exchange ratio valuing Cyclo Therapeutics shares at $.95 per share and Rafael Holdings at its cash value combined with the value of its marketable securities and certain other investments less certain current liabilities. In addition, the cash value will take into account the funding of Cyclo’s operations by Rafael with convertible notes through closing. Following the closing, Rafael Holdings intends to fund the TransportNPC™ clinical trial to its 48-week interim analysis. The boards of directors of Rafael Holdings and Cyclo Therapeutics have approved this transaction and expect it to close in late 2024, pending approval of the companies’ shareholders, the effectiveness of a registration statement to register the shares of Class B common stock of Rafael Holdings to be issued in the transaction and other customary closing conditions.
Rafael Holdings made its first strategic investment in Cyclo Therapeutics in March 2023 to help drive treatment innovation for patients with the debilitating diagnosis of Niemann-Pick Disease Type C1. Rafael Holdings led another financing round in the fall of 2023 and has continued to support Cyclo Therapeutics via convertible debt financings in 2024.
“The proposed merger with Cyclo Therapeutics is a major step forward in our strategy to invest in, develop and commercialize clinical stage assets in areas of high unmet medical need,” said Bill Conkling, President and CEO of Rafael Holdings. Bill added, “Cyclo Therapeutics continues to make substantial progress in advancing its lead asset, Trappsol® Cyclo™, announcing the completion of enrollment in its pivotal TransportNPC™ Phase 3 clinical study for the treatment of Niemann-Pick Disease Type C1 at the end of May 2024. We are impressed with the execution by the Cyclo Therapeutics team in fully enrolling a comprehensive clinical trial in NPC and we eagerly await the 48-week interim analysis in the middle of 2025. Rafael Holdings is excited to join forces with Cyclo Therapeutics to make Trappsol® Cyclo™ our lead clinical program. We are committed to the program and will leverage our resources to help bring this much needed treatment option to NPC patients.”
N. Scott Fine, Chief Executive Officer of Cyclo Therapeutics, commented, “Our partnership with Rafael Holdings during the last year and a half has enabled Cyclo to get to where we are today. We are extremely pleased to announce our merger agreement with Rafael Holdings and believe that the strength of Rafael’s balance sheet and its strong management team will solidify our commitment to deliver the results of the TransportNPC™ trial for our shareholders and patients.”
Cassel Salpeter & Co. is acting as financial advisor to Cyclo Therapeutics in connection with the transaction. Schwell Wimpfheimer & Associates is serving as legal advisor to Rafael Holdings and Fox Rothschild LLP is serving as legal advisor to Cyclo Therapeutics.
About Rafael Holdings, Inc.
Rafael Holdings is a holding company with interests in clinical and early-stage pharmaceutical companies including an investment and planned merger with Cyclo Therapeutics, Inc. (Nasdaq: CYTH), a clinical-stage biotechnology company dedicated to developing life-changing medicines for patients and families living with challenging diseases through its lead therapeutic asset, Trappsol® Cyclo™, a majority investment in Cornerstone Pharmaceuticals, Inc., formerly known as Rafael Pharmaceuticals Inc., a cancer metabolism-based therapeutics company, a majority equity interest in LipoMedix Pharmaceuticals Ltd., a clinical stage pharmaceutical company, the Barer Institute Inc., a wholly-owned preclinical cancer metabolism research operation, a majority investment in Day Three Labs, Inc., a company which reimagines existing cannabis offerings with pharmaceutical-grade technology and innovation like Unlokt™ to bring to market better, cleaner, more precise and predictable products in the cannabis industry, and a majority interest in Rafael Medical Devices, LLC, an orthopedic-focused medical device company developing instruments to advance minimally invasive surgeries. Rafael’s primary goal has been to expand its investment portfolio through opportunistic and strategic investments including therapeutics which address high unmet medical needs. Upon closing of the merger transaction with Cyclo Therapeutics, Rafael intends to focus its efforts on making Trappsol® Cyclo™ its lead clinical program.
About Cyclo Therapeutics, Inc.
Cyclo Therapeutics, Inc. 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 C, a rare and fatal genetic disease, (www.ClinicalTrials.gov NCT02939547, NCT02912793, NCT03893071 and NCT04860960). The Company 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). Additional indications for the active ingredient in Trappsol® Cyclo™ are in development. For additional information, visit the Company’s website: www.cyclotherapeutics.com.
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 in the success of the potential combination with Cyclo Therapeutics; and the potential of our pipeline. 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 Among other things, these risks include that there can be no guarantee that the proposed business combination will be completed in the anticipated timeframe or that the conditions required to complete the proposed combination will be met. In addition, these risks include, but are not limited to, those disclosed under the caption “Risk Factors” in Rafael’s Annual Report on Form 10-K for the year ended July 31, 2023, and Cyclo’s Annual Report on Form 10-K for the year ended December 31, 2023 and the companies’ other filings with the SEC. All 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 the companies’ management’s estimates as of the date of this press release. While they may elect to update such forward-looking statements at some point in the future, the companies disclaim any obligation to do so, even if subsequent events cause views to change.
No Offer or Solicitation
This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination and shall not constitute an offer to sell or a solicitation of an offer to buy any securities, nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act.
Important Additional Information Will Be Filed with the SEC
Rafael Holdings plans to file with the SEC a Registration Statement on Form S-4 in connection with the transactions and both Rafael Holdings and Cyclo Therapeutics plan to file with the SEC and mail to their respective stockholders a Joint Proxy Statement/Prospectus in connection with the transactions. Investors and security holders are urged to read the Registration Statement and the Joint Proxy Statement/Prospectus and other relevant documents filed with the SEC in connection with the proposed transaction or incorporated by reference into the Joint Proxy Statement/Prospectus (if any) carefully when they are available before making any voting or investment decision with respect to the proposed transactions. The Registration Statement, the Joint Proxy Statement/Prospectus and other documents filed with the SEC in connection with the proposed transaction or incorporated by reference into the Joint Proxy Statement/Prospectus (if any) will contain important information about Rafael Holdings, Cyclo Therapeutics, the transactions and related matters. Investors and security holders will be able to obtain free copies of the Registration Statement and the Joint Proxy Statement/Prospectus and other documents filed with the SEC by Rafael Holdings and Cyclo Therapeutics through the web site maintained by the SEC at www.sec.gov. In addition, investors and security holders will be able to obtain free copies of the Registration Statement and the Joint Proxy Statement/Prospectus from Rafael Holdings by contacting david.polinsky@rafaelholdings.com or Cyclo Therapeutics by contacting cyth@jtcir.com.
Participants in the Solicitation
Rafael and Cyclo and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies in respect of the transactions contemplated by the merger agreement. Information regarding Rafael’s directors and executive officers is contained in Rafael proxy statement dated November 20, 2023, which is filed with the SEC. Information regarding Cyclo’s directors and executive officers is contained in Cyclo’s Annual Report on Form 10-K for the year ended December 31, 2023, which is filed with the SEC. Additional information regarding the persons who may be deemed participants in the proxy solicitation and a description of their direct and indirect interests in the proposed business combination will be available in the Registration Statement and the Joint Proxy Statement / Prospectus.
Contact:
Rafael Holdings Investor Relations
Barbara Ryan
Barbara.ryan@rafaelholdings.com
(203) 274-2825
Cyclo Therapeutics Investor Relations
JTC Team, LLC
Jenene Thomas
(833) 475-8247
CYTH@jtcir.com
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