Cyclo Therapeutics Provides Business Update

Rhea-AI Summary

Cyclo Therapeutics (NASDAQ: CYTH) announces progress in its clinical programs, specifically for Trappsol® Cyclo™, targeting Alzheimer’s and Niemann-Pick Disease Type C1. The company plans to begin patient enrollment and dosing for a Phase 2 Alzheimer’s study by year-end 2022. Concurrently, the ongoing pivotal Phase 3 study (TransportNPC™) aims to enroll 93 patients across nine countries. Additionally, Cyclo plans to participate in the NPUK Annual Family Conference on October 6-7, 2022, to raise awareness about Niemann-Pick Disease.

Positive

• On track to begin Phase 2 study of Trappsol® Cyclo™ for Alzheimer’s disease by year-end 2022.
• Advancement of pivotal Phase 3 study (TransportNPC™) for Niemann-Pick Disease with robust enrollment strategy.

Negative

• None.

– Company on track to commence enrollment and dosing of Phase 2 study of Trappsol^® Cyclo™ for the treatment of Alzheimer’s disease before year end

– Ongoing advancement of global pivotal study (TransportNPC™) evaluating Trappsol^® Cyclo™ for Niemann-Pick Disease Type C1 (NPC1)

– Company to participate at the 2022 NPUK Annual Family Conference & Interactive Workshop on Niemann-Pick Disease

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 provided a business update and reiterated upcoming milestones.

“We are very pleased with our progress advancing our clinical programs evaluating Trappsol^® Cyclo™ for the treatment of NPC and Alzheimer’s disease. Of note, plans for our Phase 2 Alzheimer’s disease study remain on track to enroll and dose patients before the end of this year. Additionally, we are advancing our TransportNPC™ study and continue to build momentum related to enrollment. In addition to advancing the NPC clinical study, our team continues to dedicate time and effort to engage with the global NPC community. We are executing on all fronts and remain focused on driving the development of Trappsol^® Cyclo™ forward. The remainder of the year is poised to be exciting for Cyclo Therapeutics,” commented N. Scott Fine, CEO of Cyclo Therapeutics.

Niemann-Pick Disease Type C1 Development Program

The Company continues to advance enrollment in its ongoing pivotal Phase 3 study, TransportNPC™. The Phase 3 study intends to enroll at least 93 pediatric (age 3 years and older) and adult patients with NPC1 in at least 23 study centers in 9 countries. Eligible patients will be randomized 2:1 to receive either Trappsol^® Cyclo™ or a placebo. Randomization will not be constrained based on patient age, nor will patient enrollment be gated by patient age. The study duration is 96 weeks and includes an interim analysis at 48 weeks.

Cyclo Therapeutics is committed to connecting with the global NPC community and helping to drive awareness of this rare disease. As part of those efforts, the Company will participate at the upcoming NPUK Annual Family Conference & Interactive Workshop on Niemann-Pick Disease being held October 6-7, 2022 in Wyboston Lakes, Bedfordshire. As part of the conference, there will be an overview of Cyclo Therapeutics’ Phase 3 global clinical program, TransportNPC™, and Professor Caroline Hastings, MD, Global Principal Investigator for the TransportNPC™ study will participate in a panel discussion.

NPUK is a charitable organization dedicated to making a positive difference to the lives of those affected by Niemann-Pick diseases. Its conference will bring together attendees from the UK and throughout Europe, including patients and families, clinicians, researchers and members of industry. Toni Mathieson, CEO of NPUK and Founding Member of International Niemann Pick Disease Alliance, commented: “I believe it is only through thoughtful collaboration among industry, advocacy organizations, patients and the medical community that we can bring safe and effective treatments to those living with NPC. Cyclo Therapeutics shares this goal and has been a valuable partner for many years. We are grateful for their ongoing commitment to our NPC community in the UK and around the world, and look forward to their participation in our conference.”

For more information about the conference, please visit www.npuk.org.

Alzheimer’s Disease Asset

Cyclo Therapeutics continues to progress its plans to evaluate Trappsol^® Cyclo™ for the treatment of Alzheimer’s disease, targeting the reduction of amyloid beta and tau. In December 2021, the Company received IND clearance from the U.S. FDA to advance its Phase 2 study of intravenous Trappsol^® Cyclo™ for the treatment of Alzheimer’s disease. Clinical site selection is underway, and the Company remains on track to commence patient enrollment and dosing before the end of this year.

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 four 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 a clinical trial using Trappsol^® Cyclo™ intravenously in Alzheimer’s disease 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/20220928005988/en/

JTC Team, LLC

Jenene Thomas

(833) 475-8247

CYTH@jtcir.com

Source: Cyclo Therapeutics, Inc.

FAQ

What is Cyclo Therapeutics planning for Alzheimer’s disease treatment?

Cyclo Therapeutics aims to initiate a Phase 2 study of Trappsol® Cyclo™ for Alzheimer’s disease before the end of 2022.

How many patients will Cyclo Therapeutics enroll in its TransportNPC™ study?

The TransportNPC™ study plans to enroll at least 93 patients with Niemann-Pick Disease Type C1.

When will Cyclo Therapeutics present at the NPUK Annual Family Conference?

Cyclo Therapeutics will participate in the NPUK Annual Family Conference on October 6-7, 2022.

What is the duration of the TransportNPC™ clinical study?

The TransportNPC™ study will last 96 weeks, with an interim analysis at 48 weeks.

What is the significance of the Phase 2 study for Cyclo Therapeutics?

The Phase 2 study is critical as it evaluates Trappsol® Cyclo™'s potential for treating Alzheimer’s disease, targeting amyloid beta and tau.