Le Lézard
Classified in: Health, Science and technology
Subject: Business Update

Cyclo Therapeutics Provides Clinical Program Update and Highlights Recent Achievements


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 updates for the Company's Trappsol® Cyclotm clinical program and provided a summary of key achievements in 2022, focused on our clinical portfolio of two neurodegenerative diseases with major unmet medical needs.

"We have continued to execute and make significant progress on our clinical programs evaluating Trappsol® Cyclotm for the treatment of NPC and early Alzheimer's disease. We recently announced the commencement of patient enrollment and dosing in our early AD clinical study and are dedicated to building momentum for that program. Additionally, we continue to make significant progress in our ongoing TransportNPCtm and remain on target to have the study completely enrolled by year end, a true testament to our team's dedication, time, and effort. The Company has and will continue to focus the majority of its resources, both human and capital, to the NPC community and on advancing the TransportNPCtm study, an important area with significant unmet need," commented N. Scott Fine, CEO of Cyclo Therapeutics. "We made noteworthy advancements in 2022 and are continuing to execute on all fronts. We look forward to an exciting year ahead."

Trappsol® Cyclotm Clinical Program Update

Trappsol® Cyclotm is the Company's proprietary formulation of hydroxypropyl beta cyclodextrin, used intravenously (IV) and currently in development for the treatment of NPC, a rare genetic disorder causing cholesterol accumulation in lysosomes of cells, organ dysfunction and premature death, and early Alzheimer's Disease (AD), where disrupted lipid pathways play a key role in the etiology and disease progression.

Niemann-Pick Disease Type C1 Development Program

For more information about the Company's Trappsol® Cyclotm clinical program for the treatment of NPC1, visit www.ClinicalTrials.gov and reference identifiers NCT02939547, NCT02912793, NCT03893071 and NCT04860960.

Alzheimer's Disease Development Program

With the biologic similarities demonstrated between Alzheimer's disease and Niemann-Pick disease Type C1 and, including cholesterol accumulation in regions of the brain, elevated levels of Tau in cerebrospinal fluid ("CSF"), and amyloid plaques in the brain, the Company believes Trappsol® Cyclotm has significant potential to be an effective treatment option for Alzheimer's disease.

For more information about the Company's Trappsol® Cyclotm clinical program for the treatment of early AD and Expanded Access program, visit www.ClinicalTrials.gov and reference identifiers NCT05607615 and NCT03624842, respectively.

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® Cyclotm, 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 conducting a Phase 2b clinical trial using Trappsol® Cyclotm 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® Cyclotm 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.


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