Cyclo Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update
Cyclo Therapeutics (NASDAQ: CYTH) reported Q3 2024 financial results and business updates. Key highlights include a strategic merger with Rafael Holdings expected to close in Q4 2024, completion of enrollment in Phase 3 TransportNPC™ trial, and qualification for Priority Review Voucher. The company targets topline data from 48-week interim analysis in H1 2025, followed by NDA and MAA submissions in H2 2025. Financial results show a net loss of $8.8 million, with R&D expenses increasing 57% to $5.5 million compared to Q3 2023. Cash position at quarter-end was $0.9 million.
Cyclo Therapeutics (NASDAQ: CYTH) ha riportato i risultati finanziari per il terzo trimestre del 2024 e aggiornamenti sull'attività. I punti salienti includono una fusione strategica con Rafael Holdings prevista per la chiusura nel quarto trimestre del 2024, il completamento dell'arruolamento nella fase 3 dello studio TransportNPC™, e la qualificazione per il Voucher di Revisione Prioritaria. L'azienda punta a dati preliminari dall'analisi intermedia di 48 settimane nella prima metà del 2025, seguiti dalle presentazioni NDA e MAA nella seconda metà del 2025. I risultati finanziari mostrano una perdita netta di 8,8 milioni di dollari, con le spese per R&S aumentate del 57%, raggiungendo i 5,5 milioni di dollari rispetto al terzo trimestre del 2023. La posizione di cassa a fine trimestre era di 0,9 milioni di dollari.
Cyclo Therapeutics (NASDAQ: CYTH) informó los resultados financieros del tercer trimestre de 2024 y actualizaciones comerciales. Los aspectos destacados incluyen una fusión estratégica con Rafael Holdings que se espera cierre en el cuarto trimestre de 2024, la finalización de la inscripción en el ensayo de fase 3 TransportNPC™, y la calificación para el Voucher de Revisión Prioritaria. La compañía tiene como objetivo los datos de la análisis intermedia de 48 semanas en la primera mitad de 2025, seguidos por la presentación de NDA y MAA en la segunda mitad de 2025. Los resultados financieros muestran una pérdida neta de 8.8 millones de dólares, con los gastos de I+D aumentando un 57% a 5.5 millones de dólares en comparación con el tercer trimestre de 2023. La posición de efectivo al final del trimestre era de 0.9 millones de dólares.
사이클로 테라퓨틱스 (NASDAQ: CYTH)는 2024년 3분기 재무 결과 및 사업 업데이트를 보고했습니다. 주요 하이라이트로는 2024년 4분기에 마감될 예정인 라파엘 홀딩스와의 전략적 합병, 3상 TransportNPC™ 시험 등록 완료, 우선 심사 바우처 자격 획득 등이 있습니다. 회사는 2025년 상반기에 48주 중간 분석의 주요 데이터를 목표로 하고 있으며, 2025년 하반기 NDA 및 MAA 제출이 예정되어 있습니다. 재무 결과는 880만 달러의 순손실을 보여주며, R&D 비용은 2023년 3분기와 비교하여 57% 증가한 550만 달러에 달합니다. 분기말 현금 잔고는 90만 달러였습니다.
Cyclo Therapeutics (NASDAQ: CYTH) a présenté ses résultats financiers du troisième trimestre 2024 et des mises à jour commerciales. Les faits marquants incluent une fusion stratégique avec Rafael Holdings prévue pour clôturer au quatrième trimestre 2024, l'achèvement de l'inscription dans l'essai TransportNPC™ de phase 3, et l'obtention d'un Voucher de Révision Prioritaire. L'entreprise vise des données préliminaires de l'analyse intermédiaire de 48 semaines au premier semestre 2025, suivies des soumissions NDA et MAA au second semestre 2025. Les résultats financiers montrent une perte nette de 8,8 millions de dollars, avec des dépenses de R&D augmentant de 57 % à 5,5 millions de dollars par rapport au troisième trimestre 2023. La position de trésorerie à la fin du trimestre était de 0,9 million de dollars.
Cyclo Therapeutics (NASDAQ: CYTH) berichtete über die finanziellen Ergebnisse des dritten Quartals 2024 und Geschäftsaktualisierungen. Zu den wichtigsten Punkten gehört eine strategische Fusion mit Rafael Holdings, die voraussichtlich im vierten Quartal 2024 abgeschlossen wird, der Abschluss der Patienteneinschreibung in der Phase 3 TransportNPC™-Studie und die Qualifizierung für einen Priority Review Voucher. Das Unternehmen zielt darauf ab, in der ersten Hälfte von 2025 vorläufige Daten aus einer 48-wöchigen Zwischenanalyse zu präsentieren, gefolgt von NDA- und MAA-Einreichungen in der zweiten Hälfte von 2025. Die finanziellen Ergebnisse zeigen einen Nettoverlust von 8,8 Millionen Dollar, während die F&E-Ausgaben im Vergleich zum dritten Quartal 2023 um 57 % auf 5,5 Millionen Dollar gestiegen sind. Die Liquiditätsposition am Quartalsende betrug 0,9 Millionen Dollar.
- Strategic merger with Rafael Holdings to strengthen development of Trappsol® Cyclo™
- Completed enrollment in Phase 3 TransportNPC™ trial
- Qualified for Priority Review Voucher upon NDA submission
- Received European patent grant for Alzheimer's Disease treatment methods
- Net loss of $8.8 million in Q3 2024
- R&D expenses increased 57% year-over-year
- Low cash position of $0.9 million at quarter-end
Insights
The Q3 financial results reveal concerning metrics with a significant
The TransportNPC™ trial progression and potential Priority Review Voucher qualification are promising developments, but the company's tight cash position could create near-term financing pressure. The targeted H2 2025 NDA submission timeline suggests continued high operational costs through 2025, necessitating additional funding beyond the merger to sustain operations.
The completion of enrollment in the Phase 3 TransportNPC™ trial represents a significant milestone. The upcoming 48-week interim analysis in H1 2025 is a critical catalyst that could validate Trappsol® Cyclo™'s efficacy in treating NPC1. The preliminary data presented at SSIEM Symposium and the potential for Priority Review status indicate positive momentum in the clinical development pathway.
However, the extended timeline to H2 2025 for regulatory submissions suggests a lengthy path to potential commercialization. The European patent grant for Alzheimer's Disease methods adds portfolio value but remains a secondary consideration to the core NPC1 program.
Strategic merger with Rafael Holdings to combine two companies and advance Trappsol® Cyclo™ for NPC1 patients expected to close Q4 2024
Company on track for topline data from the 48-week interim analysis of 104 enrolled patients in TransportNPC™ in H1 2025
Submission of New Drug Application (NDA) to the Food and Drug Administration (FDA) and Marketing Authorization Application (MAA) to European Medicines Agency (EMA) targeted for H2 2025
Qualification for Priority Review Voucher expected upon NDA submission
“The third quarter has been marked by important advancements on our clinical and corporate fronts. We are poised to complete our TransportNPC™ study next year and believe the findings most recently presented at the SSIEM Symposium further emphasize the potential of Trappsol® Cyclo™ to provide a transformational impact for all people living with NPC,” commented N. Scott Fine, CEO of Cyclo Therapeutics. “Furthermore, the merger with Rafael Holdings is a crucial step forward in our overall strategy and commitment to unlock the full potential of the TransportNPC™ trial for our shareholders and most importantly, the NPC community globally.”
Recent Highlights
- Entered into a definitive merger agreement with Rafael Holdings to combine the two companies to focus on the development of Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C1. The merger is expected to close before year-end 2024.
- Achieved completion of enrollment in Phase 3 pivotal TransportNPC™ trial of Niemann-Pick Type C1. If 48-week data demonstrate significance, submission of NDA to FDA and MAA to EMA is targeted for 2H 2025.
- Received qualification for Priority Review Voucher upon NDA submission.
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Presented positive preliminary data from ongoing pivotal Phase 3 TransportNPC™ trial and substudy evaluating Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C1 in two poster presentations at the SSIEM Annual Symposium 2024 that was held in
Porto, Portugal . - Received a notice from the European Patent Office of a decision to grant European patent application No. 19805439.7 titled, “Methods for Treating Alzheimer’s Disease” under European patent number 3873604B.
Summary of Financial Results for the Third Quarter 2024
Net loss for the quarter ended September 30, 2024 was approximately
The Company ended the quarter with approximately
About Cyclo Therapeutics
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
Safe Harbor Statement
This press release contains “forward-looking statements” about the company’s current expectations about future results, performance, prospects and opportunities, including, without limitation, statements regarding the satisfaction of closing conditions relating to the offering and the anticipated use of proceeds from the offering. Statements that are not historical facts, such as “anticipates,” “believes” and “expects” or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual results in future periods to differ materially from what is expressed in, or implied by, these statements. The factors which may influence the company’s future performance include the company’s ability to obtain additional capital to expand operations as planned, success in achieving regulatory approval for clinical protocols, enrollment of adequate numbers of patients in clinical trials, unforeseen difficulties in showing efficacy of the company’s biopharmaceutical products, success in attracting additional customers and profitable contracts, and regulatory risks associated with producing pharmaceutical grade and food products. These and other risk factors are described from time to time in the company’s filings with the Securities and Exchange Commission, including, but not limited to, the company’s reports on Forms 10-K and 10-Q. Unless required by law, the company assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
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Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
CYTH@jtcir.com
Source: Cyclo Therapeutics, Inc.
FAQ
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