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Cyclo Therapeutics (CYTH) investor relations material
Cyclo Therapeutics Corporate Presentation summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Corporate Presentation summary17 Dec, 2024
Company overview and strategy
Cyclo Therapeutics leverages over 30 years of cyclodextrin expertise, focusing on rare and neurodegenerative diseases with unmet needs, notably Niemann-Pick Disease Type C (NPC) and Alzheimer's disease.
Trappsol® Cyclo™ is a proprietary hydroxypropyl beta cyclodextrin formulation designed to facilitate cholesterol transport out of lysosomes, addressing cholesterol accumulation in NPC and potentially Alzheimer's.
The company has a strategic partnership with Rafael Holdings, providing $24M in committed capital and board representation.
A definitive merger agreement with Rafael Holdings was signed in August 2024 to focus on Trappsol® Cyclo™ for NPC1.
Leadership team includes experienced executives from major pharma and biotech companies.
Clinical pipeline and progress
Trappsol® Cyclo™ is in a pivotal Phase 3 trial (Transport NPC) for NPC; enrollment of 104 patients completed in May 2024, with 48-week interim topline data expected in H1 2025.
The Phase 3 trial spans 30+ sites across 14 countries, with primary endpoint NPC Composite Severity Score and secondary endpoints including SCAFI and Vineland-2.
Phase 1 and 2 studies demonstrated safety, tolerability, and potential efficacy in stabilizing or improving systemic and neurological symptoms of NPC.
Ongoing long-term extension study shows durability of effect, with patients exhibiting slowed disease progression and consistent safety.
Trappsol® Cyclo™ has Orphan Drug and Fast Track designations in the US and EU, with potential for a Priority Review Voucher.
Clinical data and safety
Preclinical and clinical data show Trappsol® Cyclo™ effectively mobilizes cholesterol from lysosomes, normalizes cholesterol metabolism, and is detectable in CSF after IV infusion.
Phase 1/2 studies showed 100% of patients were stable or improved, with 89% showing improvement over expected disease progression on the 5D-NPC-SS scale.
Safety profile is favorable, with most adverse events mild to moderate and manageable; hearing loss and infusion reactions are monitored, with most hearing events resolving.
Biomarker data indicate reduced cholesterol synthesis and increased catabolism, supporting the mechanism of action.
Higher doses (2000–2500 mg/kg) suggest greater benefit in SARA domains such as gait, stance, and speech.
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Frequently asked questions
Cyclo Therapeutics Inc. is a biotechnology company focused on developing treatments for rare neurodegenerative and metabolic diseases. The company specializes in cyclodextrin-based therapies aimed at addressing conditions such as Niemann-Pick Disease Type C and Alzheimer’s disease. The company is headquartered in Gainesville, Florida, and its shares are listed on the NASDAQ.
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