Cyclo Therapeutics Q2 2024 Financial Results and Business Update

Cyclo Therapeutics, Inc. (Nasdaq: CYTH), a biotechnology company focused on developing innovative treatments, has announced its financial results for the second quarter of 2024 and shared a business update.

CEO N. Scott Fine highlighted the company’s significant progress, particularly the completion of patient enrollment in the pivotal Phase 3 TransportNPC™ trial for Niemann-Pick Type C1 (NPC1). This marks a transformative period for Cyclo Therapeutics as they prepare for an interim data readout expected in the first quarter of 2025, which could lead to a new treatment option for NPC1.

Key Achievements:
1. Completion of Phase 3 Enrollment: The company has completed enrollment for the TransportNPC™ trial. If the 48-week data show significant results, Cyclo Therapeutics plans to submit a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the EMA in the second half of 2025. They also aim to qualify for a Priority Review Voucher (PRV) upon NDA submission.
2. Community Engagement: Cyclo Therapeutics has actively engaged with the NPC community by participating in events like the Latin American School of Medical and Human Genetics Annual Meeting, the Australian NPC Foundation Conference, and the NNPDF Family Support & Medical Conference.
3. Research Presentations: The company announced that two abstracts have been accepted for poster presentation at the SSIEM Annual Symposium 2024, scheduled for September 3-6 in Porto, Portugal.
4. European Patent: Cyclo Therapeutics received notice from the European Patent Office granting their patent application for methods treating Alzheimer’s Disease. This European patent will take effect on August 21, 2024.

Financial Summary for the Second Quarter 2024:
- Net Loss: The company reported a net loss of approximately $6.0 million for the quarter ending June 30, 2024.
- R&D Expenses: Research and development expenses increased by 10%, reaching $3.5 million, up from $3.2 million in the same period in 2023. This increase is attributed to the completion of patient enrollment in the NPC program.
- Cash Position: Cyclo Therapeutics ended the quarter with around $1.1 million in cash.

Company Overview:
Cyclo Therapeutics, Inc. is dedicated to developing life-changing medicines for patients with rare diseases. Their lead product, Trappsol® Cyclo™, is an orphan drug designated in the U.S. and Europe and is currently undergoing four clinical trials for Niemann-Pick Disease Type C1 (NPC1). The trials are registered under the identifiers NCT02939547, NCT02912793, NCT03893071, and NCT04860960. Additionally, the company is conducting a Phase 2b trial for early Alzheimer’s disease (NCT05607615), leveraging positive data from an Expanded Access program (NCT03624842). Cyclo Therapeutics is also exploring other potential uses for the active ingredient in Trappsol® Cyclo™.

The company’s commitment to scientific research and community engagement underscores their mission to provide innovative and effective treatments for those affected by rare and challenging diseases.

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