Cyclo Therapeutics to Present at the 2021 NPC Patient and Family Conference Hosted by the Australian NPC Disease Foundation

Rhea-AI Summary

Cyclo Therapeutics, Inc. (Nasdaq: CYTH) will present at the 2021 NPC Conference on June 25-26, 2021. The session will cover their intravenous formulation of Trappsol® Cyclo™ for treating Niemann-Pick Disease Type C (NPC) and its clinical development progress. Presentations include results from Phase 1 and 1/2 studies and details on the pivotal Phase 3 study (TransportNPC) now underway. Cyclo Therapeutics has received Orphan Drug Designation for Trappsol® Cyclo™ in both the US and EU and aims for significant advancements in NPC treatment.

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 it will present at the 2021 NPC Conference hosted by the Australian NPC Disease Foundation being held virtually June 25-26, 2021.

The Cyclo Therapeutics session will be held Friday, June 25, 2021, 11 AM – 12 PM AEST / Thursday, June 24, 2021, 9 PM – 10 PM EDT. During the session, Cyclo Therapeutics will discuss its proprietary formulation of hydroxypropyl beta cyclodextrin, Trappsol^® Cyclo™, delivered intravenously, and the progress of its clinical development program for the treatment of NPC. Details of the Company’s presentation are as follows:

Title:		Results from Phase 1 Study to Evaluate the Single- and Multiple-Dose Pharmacokinetics of Intravenous Trappsol® Cyclo™ in Patients with Niemann-Pick Disease Type C (NPC-1) and the Effects of Dosing upon Biomarkers of NPC Disease
Presenter:		Caroline Hastings, MD, Director, Pediatric Hematology Oncology Fellowship Program, Children's Hospital & Research Center Oakland and Professor of Pediatrics, University of California, San Francisco, School of Medicine
Title:		Top Line Results from Phase 1/2 Study to Evaluate Safety and Efficacy of Intravenous Trappsol® Cyclo™ in Patients with Niemann-Pick Disease Type C1
Presenter:		Julian AJ Raiman MBBS MSc MRCP, Consultant Inherited Metabolic Disease, Birmingham Children's Hospital, Birmingham, UK
Title:		Phase 3 Study (TransportNPC) to Evaluate Intravenous Trappsol® Cyclo™ in Pediatric and Adult Patients with Niemann-Pick Disease Type C1
Presenter:		Gerald Cox, MD PhD, Acting Chief Medical Officer, Cyclo Therapeutics, Inc.

A live webcast of the presentation will be available to registered attendees. The presentations will also be made available on the Presentations page in the Investors section of the Company’s website. For more information about the event, please visit: www.npcd.org.au/npcconf2021.

Cyclo Therapeutics recently announced the commencement of its pivotal Phase 3 study (“TransportNPC”) evaluating Trappsol^® Cyclo™ for the treatment of NPC. The TransportNPC study has the regulatory and IRB approval required to commence patient enrollment, and site activation is underway. For more information about the TransportNPC study, visit www.ClinicalTrials.gov and reference identifier NCT04860960.

Cyclo Therapeutics has received Orphan Drug Designation for Trappsol^® Cyclo™ to treat NPC in both the US and EU, and additionally, Fast Track and Rare Pediatric Disease Designations in the US. The Rare Pediatric Disease Designation is one of the chief requirements for sponsors to receive a Priority Review Voucher in the US upon marketing authorization.

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 suffering from disease. The Company’s Trappsol^® Cyclo™, an orphan drug designated product in the United States and Europe, is the subject of three ongoing formal clinical trials for Niemann-Pick Disease Type C, a rare and fatal genetic disease, (www.ClinicalTrials.gov NCT02939547, NCT02912793, NCT03893071 and NCT04860960). The Company is planning an early phase clinical trial using Trappsol^® Cyclo™ intravenously in Alzheimer’s Disease based on encouraging data from an Expanded Access program for late-onset 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/20210621005110/en/

FAQ

When will Cyclo Therapeutics present at the 2021 NPC Conference?

Cyclo Therapeutics will present at the 2021 NPC Conference on June 25, 2021, from 11 AM – 12 PM AEST.

What product is Cyclo Therapeutics discussing at the NPC Conference?

Cyclo Therapeutics will discuss their intravenous formulation, Trappsol® Cyclo™, for treating Niemann-Pick Disease Type C.

What are the key studies Cyclo Therapeutics will present?

They will present results from Phase 1 and 1/2 studies, and details about the pivotal Phase 3 study (TransportNPC) for NPC treatment.

What designations has Trappsol® Cyclo™ received?

Trappsol® Cyclo™ has received Orphan Drug Designation in both the US and EU, along with Fast Track and Rare Pediatric Disease Designations in the US.

Where can I find more information about the TransportNPC study?

More information about the TransportNPC study can be found on ClinicalTrials.gov under the identifier NCT04860960.