Cyclo Therapeutics to Present at the 21st Annual WORLDSymposium™ 2025

Rhea-AI Summary

Cyclo Therapeutics (NASDAQ: CYTH) has announced its participation in the 21st Annual WORLDSymposium™ 2025, scheduled for February 3-7, 2025 in San Diego. The company will present research on their drug Trappsol® Cyclo™ through multiple sessions.

The presentations include an oral session by Dr. Ronen Spiegel focusing on the TransportNPC™ Sub-Study in patients under age 3 with Niemann-Pick Disease Type C1, scheduled for February 6, 2025. Additionally, Dr. Caroline Hastings will present two posters on the long-term treatment efficacy and safety data from clinical studies and the ongoing Expanded Access Program.

Trappsol® Cyclo™, which has received orphan drug designation in the United States and Europe, is currently being evaluated in four formal clinical trials for Niemann-Pick Disease Type C1 and a Phase 2b trial for early Alzheimer's disease. The research presentations will highlight clinical applications and outcomes of the treatment.

Pivotal Phase 3 global study (TransportNPC™) evaluating Trappsol^® Cyclo™ for Niemann-Pick Disease Type C1 (“NPC1”) to be highlighted in an oral presentation

GAINESVILLE, Fla.--(BUSINESS WIRE)-- Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today announced its abstracts have been accepted for oral and poster presentation at the 21^st Annual WORLDSymposium™ being held February 3-7, 2025 in San Diego, CA.

Details of the presentations are as follows:

Oral Presentation:

Title: Trappsol^® Cyclo™: Open Label Treatment in the TransportNPC™ Sub-Study in Patients Under the Age of 3 Diagnosed with Niemann-Pick Disease Type C1
Presenter: Ronen Spiegel, MD, Clinical Associate Professor, Director of Pediatric B Department, and Co-Director Center of Rare Disease at Emek Medical Center
Session: Clinical Applications
Date and Time: Thursday, February 6, 2025 at 1:30 PM PT

Poster Presentations:

Title: Trappsol^® Cyclo™ (HPβCD) for the Long-Term Treatment of Niemann-Pick Type C1: Efficacy and Safety Data from 4 Clinical Studies and the Ongoing Expanded Access Program
Presenter: Dr. Caroline Hastings, Pediatric hematologist oncologist, Director of Neuro-oncology, and Professor of Pediatrics at UCSF Benioff Children’s Hospital Oakland
Session: Clinical Applications & Rapid-Fire – Poster Session III
Date and Time: Thursday, February 6, 2025 from 3:30 – 5:30 PM PT

Title: Trappsol^® Cyclo™ and NPC: Efficacy Shown Across Individual 5D Domains and Utilization of Future Assessment Tools to Demonstrate Clinically Relevant Outcomes
Presenter: Dr. Caroline Hastings, Pediatric hematologist oncologist, Director of Neuro-oncology, and Professor of Pediatrics at UCSF Benioff Children’s Hospital Oakland
Session: Clinical Applications & Rapid-Fire – Poster Session III
Date and Time: Thursday, February 6, 2025 from 3:30 – 5:30 PM PT

For more information, please visit the conference website worldsymposia.org.

About WORLDSymposium™

WORLDSymposium™ is an annual research conference dedicated to lysosomal diseases. WORLD is an acronym that stands for We’re Organizing Research on Lysosomal Diseases. Since its inception as a small group of passionate researchers in 2002, WORLDSymposium™ has grown to an international research conference that attracts over 2000 participants from more than 50 countries around the globe. For more information, please visit: worldsymposia.org.

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 the United States and Europe, is the subject of four formal clinical trials for Niemann-Pick Disease Type C1, a rare and fatal genetic disease, (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.

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/20250114456775/en/

Investor Contact:

JTC Team, LLC

Jenene Thomas

(908) 824-0775

CYTH@jtcir.com

Source: Cyclo Therapeutics, Inc.

FAQ

What will be presented at WORLDSymposium 2025 regarding CYTH's Trappsol® Cyclo™?

Three presentations will be made: one oral presentation about the TransportNPC™ Sub-Study in young patients, and two poster presentations focusing on long-term treatment efficacy and safety data, as well as efficacy across 5D domains.

How many clinical trials is CYTH currently conducting for Trappsol® Cyclo™?

CYTH is conducting four formal clinical trials for Niemann-Pick Disease Type C1 and a Phase 2b clinical trial for early Alzheimer's disease.

When and where will CYTH present at WORLDSymposium 2025?

The presentations will take place on February 6, 2025, in San Diego, CA, with the oral presentation at 1:30 PM PT and poster sessions from 3:30-5:30 PM PT.

What regulatory designations has CYTH's Trappsol® Cyclo™ received?

Trappsol® Cyclo™ has received orphan drug designation in both the United States and Europe.

Which diseases is CYTH targeting with Trappsol® Cyclo™?

CYTH is primarily targeting Niemann-Pick Disease Type C1, a rare and fatal genetic disease, and early Alzheimer's disease.