- Company dedicated to developing life-changing medicines through science and innovation for patients and families living with challenging diseases

- Pivotal Phase 3 study of Trappsol^® Cyclo™ for Niemann-Pick Disease Type C (NPC) on track to commence site activation to begin enrollment this month

- Company advancing Alzheimer’s Disease Phase 2 asset towards investigational new drug application (IND) filing anticipated in H2 2021

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 suffering from diseases, today announced the launch of its new corporate website, cyclotherapeutics.com.

“As we drive development of our potentially life-changing medicines, delivering treatment benefit to patients and families suffering from NPC and Alzheimer’s Disease remain at the forefront of our motivation and goal. Our Company is committed to remaining active in the patient, as well as investor communities to build awareness, much needed hope and ultimately shareholder value,” commented N. Scott Fine, Chief Executive Officer of Cyclo Therapeutics.

The Company’s lead product in development, Trappsol^® Cyclo™ is a 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. Following the recent positive topline data readout from its Phase 1/2 clinical trial, which demonstrated promising safety and efficacy results, the Company is preparing to commence its pivotal Phase 3 study evaluating Trappsol^® Cyclo™ for the treatment of NPC. Cyclo Therapeutics remains on track to commence patient enrollment in June 2021.

Additionally, Cyclo Therapeutics is advancing its development of Trappsol^® Cyclo™ for the treatment of Alzheimer’s Disease, targeting the reduction of amyloid beta and tau. Following a positive Type B interaction with the FDA, the Company received positive feedback supporting its development strategy to submit an IND application for a Phase 2 study of intravenous Trappsol^® Cyclo™ in the treatment of early Alzheimer’s disease. The Company is on track to file its IND for a Phase 2 study of Alzheimer’s disease in the second half of 2021.

For more information, please visit cyclotherapeutics.com.

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/20210615005172/en/