Cyclo Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update
Cyclo Therapeutics (Nasdaq: CYTH) reported its Q2 2024 financial results and provided a business update. Key highlights include:
1. Completed enrollment in the pivotal Phase 3 TransportNPC™ trial for Niemann-Pick Disease Type C1 (NPC1).
2. Topline data from the 48-week interim analysis expected in H1 2025.
3. Targeting NDA and MAA submissions in 2H 2025 if data shows significance.
4. Net loss for Q2 2024 was approximately $6.0 million.
5. R&D expenses increased 10% to $3.5 million.
6. Cash position at quarter-end was approximately $1.1 million.
The company is focused on developing Trappsol® Cyclo™ for NPC1 and early Alzheimer's disease, with potential for a Priority Review Voucher upon NDA submission.
Cyclo Therapeutics (Nasdaq: CYTH) ha riportato i risultati finanziari del secondo trimestre 2024 e ha fornito un aggiornamento aziendale. I punti salienti includono:
1. Completata l'arruolamento nella fase cruciale dello studio di Fase 3 TransportNPC™ per la malattia di Niemann-Pick di tipo C1 (NPC1).
2. I dati preliminari dall'analisi intermedia di 48 settimane sono attesi nella prima metà del 2025.
3. Target per la presentazione della NDA e della MAA nella seconda metà del 2025, se i dati mostrano significatività.
4. La perdita netta per il secondo trimestre 2024 è stata di circa 6,0 milioni di dollari.
5. Le spese per R&S sono aumentate del 10% raggiungendo 3,5 milioni di dollari.
6. La posizione di cassa a fine trimestre era di circa 1,1 milioni di dollari.
L'azienda è focalizzata sullo sviluppo di Trappsol® Cyclo™ per NPC1 e per l'Alzheimer precoce, con possibilità di ottenere un Voucher per Revisione Prioritaria al momento della presentazione della NDA.
Cyclo Therapeutics (Nasdaq: CYTH) informó sus resultados financieros del segundo trimestre de 2024 y brindó una actualización sobre el negocio. Los aspectos destacados incluyen:
1. Finalizada la inscripción en el ensayo pivotal de Fase 3 TransportNPC™ para la enfermedad de Niemann-Pick tipo C1 (NPC1).
2. Se espera que los datos preliminares del análisis intermedio de 48 semanas se publiquen en la primera mitad de 2025.
3. Se prevé presentar la NDA y la MAA en la segunda mitad de 2025 si los datos muestran significancia.
4. La pérdida neta para el segundo trimestre de 2024 fue de aproximadamente 6,0 millones de dólares.
5. Los gastos en I+D aumentaron un 10% hasta alcanzar los 3,5 millones de dólares.
6. La posición de efectivo al final del trimestre era de aproximadamente 1,1 millones de dólares.
La empresa se enfoca en el desarrollo de Trappsol® Cyclo™ para NPC1 y la enfermedad de Alzheimer en etapas tempranas, con potencial para obtener un Voucher de Revisión Prioritaria una vez presentada la NDA.
Cyclo Therapeutics (Nasdaq: CYTH)는 2024년 2분기 재무 결과를 발표하고 사업 업데이트를 제공했습니다. 주요 내용은 다음과 같습니다:
1. Niemann-Pick Disease Type C1 (NPC1)에 대한 주요 Phase 3 TransportNPC™ 시험에서 등록이 완료되었습니다.
2. 48주 중간 분석의 주요 데이터는 2025년 상반기에 예상됩니다.
3. 데이터가 의미 있는 경우 2025년 하반기에 NDA 및 MAA 제출을 목표로 하고 있습니다.
4. 2024년 2분기 순손실은 약 600만 달러였습니다.
5. R&D 비용이 10% 증가해 350만 달러에 달했습니다.
6. 분기 말 현금 잔고는 약 110만 달러였습니다.
회사는 NPC1 및 초기 알츠하이머 질환을 위한 Trappsol® Cyclo™ 개발에 집중하고 있으며, NDA 제출 시 우선 심사 바우처를 받을 수 있는 잠재력이 있습니다.
Cyclo Therapeutics (Nasdaq: CYTH) a publié ses résultats financiers du deuxième trimestre 2024 et a fourni une mise à jour sur l'entreprise. Les points clés incluent :
1. Inscription terminée dans l'essai pivot de Phase 3 TransportNPC™ pour la maladie de Niemann-Pick de type C1 (NPC1).
2. Les données préliminaires de l'analyse intermédiaire de 48 semaines sont attendues au premier semestre 2025.
3. Cible pour les soumissions de NDA et de MAA au deuxième semestre 2025 si les données montrent une signification.
4. La perte nette pour le deuxième trimestre 2024 était d'environ 6,0 millions de dollars.
5. Les dépenses en R&D ont augmenté de 10 % pour atteindre 3,5 millions de dollars.
6. La position de trésorerie à la fin du trimestre était d'environ 1,1 million de dollars.
L'entreprise se concentre sur le développement de Trappsol® Cyclo™ pour NPC1 et la maladie d'Alzheimer précoce, avec un potentiel pour un Voucher de Révision Prioritaire lors de la soumission de la NDA.
Cyclo Therapeutics (Nasdaq: CYTH) hat seine finanziellen Ergebnisse für das zweite Quartal 2024 veröffentlicht und ein geschäftliches Update gegeben. Wichtige Punkte sind:
1. Einschreibung in die entscheidende Phase-3-Studie TransportNPC™ für die Niemann-Pick-Krankheit Typ C1 (NPC1) abgeschlossen.
2. Topline-Daten aus der 48-wöchigen Zwischenanalyse werden im ersten Halbjahr 2025 erwartet.
3. Ziel ist die Einreichung von NDA und MAA in der zweiten Jahreshälfte 2025, falls die Daten signifikant sind.
4. Der Nettoverlust für das zweite Quartal 2024 betrug etwa 6,0 Millionen US-Dollar.
5. Die F&E-Ausgaben stiegen um 10 % auf 3,5 Millionen US-Dollar.
6. Die Liquiditätsposition zum Quartalsende betrug etwa 1,1 Millionen US-Dollar.
Das Unternehmen konzentriert sich auf die Entwicklung von Trappsol® Cyclo™ für NPC1 und frühe Alzheimer-Krankheit, mit dem Potenzial für einen Priority Review Voucher bei der NDA-Einreichung.
- Completed enrollment in pivotal Phase 3 TransportNPC™ trial for NPC1
- Topline data from 48-week interim analysis expected in H1 2025
- Potential for Priority Review Voucher upon NDA submission
- Two abstracts accepted for poster presentation at SSIEM Annual Symposium 2024
- European patent granted for 'Methods for Treating Alzheimer's Disease'
- Net loss of $6.0 million in Q2 2024
- R&D expenses increased 10% to $3.5 million
- Low cash position of $1.1 million at quarter-end
Cyclo Therapeutics' Q2 2024 results reveal a net loss of
The completion of enrollment in the Phase 3 TransportNPC™ trial for Niemann-Pick Disease Type C1 (NPC1) is a important development. With 104 patients enrolled, the study has significant statistical power. The planned interim analysis at 48 weeks, expected in H1 2025, could provide pivotal data on Trappsol® Cyclo™'s efficacy. NPC1 is a rare, fatal genetic disorder with treatment options, making this trial highly impactful. Additionally, the company's expansion into Alzheimer's disease research with a Phase 2b trial showcases potential for broader applications of their technology. These advancements position Cyclo Therapeutics at the forefront of addressing unmet medical needs in rare and neurodegenerative diseases.
Cyclo Therapeutics' focus on rare diseases like NPC1 and expansion into Alzheimer's disease presents a strategic market positioning. The orphan drug designation for Trappsol® Cyclo™ in the US and Europe offers significant market advantages, including extended exclusivity and potential for premium pricing. The possible qualification for a Priority Review Voucher upon NDA submission adds substantial value, as these vouchers can be sold for hundreds of millions of dollars. The company's engagement with the NPC community through various conferences demonstrates commitment to patient-centric development. However, investors should be aware of the competitive landscape in Alzheimer's research, where many larger companies are also vying for breakthroughs.
Quarter marked by achievement of landmark milestone with completion of enrollment in pivotal Phase 3 study (“TransportNPC™”) evaluating Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C1 (NPC1)
Topline data from the 48-week interim analysis of 104 enrolled patients in TransportNPC™ on track for H1 2025
“The second quarter represents a transformative time for the Company with the achievement of a landmark milestone -- the completion of enrollment in our pivotal TransportNPC™ trial. I am extremely pleased with the progress our entire team has made with this important program. Equipped with the positive support, feedback and alignment from our recent health authority interactions with both the FDA and EMA coupled with the completion of enrollment, we are highly focused on the interim data readout expected in Q1 2025. What this means is that we believe we will be generating the data required to provide a much-needed treatment option for the treatment of NPC1,” commented N. Scott Fine, CEO of Cyclo Therapeutics.
Recent Highlights
- Achieved completion of enrollment in Phase 3 Pivotal TransportNPC™ Trial of Niemann-Pick Type C1. If 48-week data demonstrate significance, submission of New Drug Application (NDA) to the Food and Drug Administration (FDA) and Marketing Authorization Application (MAA) to European Medicines Agency (EMA) is targeted for 2H 2025; Qualification for Priority Review Voucher (PRV) upon NDA submission;
- Continued NPC community engagement through attendance at the Latin American School of Medical and Human Genetics Annual Meeting (ELAG), Australian NPC Foundation Conference, and NNPDF Family Support & Medical Conference;
-
Announced two abstracts have been accepted for poster presentation at the SSIEM Annual Symposium 2024 being held September 3-6, 2024, in
Porto, Portugal ; and - 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. The notice states that mention of the decision will be published on August 21, 2024 in European Patent Bulletin 24/34 and will take effect on that date.
Summary of Financial Results for the Second Quarter 2024
Net loss for the quarter ended June 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240815845065/en/
Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
CYTH@jtcir.com
Source: Cyclo Therapeutics, Inc.
FAQ
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