Cyclo Therapeutics Unveils New Corporate Identity and Reaffirms Commitment to Improving Quality of Life and Providing Hope for Patients and Families

Rhea-AI Summary

Cyclo Therapeutics (Nasdaq: CYTH) has launched a new corporate identity ahead of Rare Disease Day, emphasizing its commitment to patients with unmet medical needs. The company focuses on developing Trappsol® Cyclo™, an intravenous treatment for Niemann-Pick Disease Type C and late-onset Alzheimer’s Disease. FDA has acknowledged their pivotal Phase 3 study for NPC1 may commence, with enrollment expected in Q2 2021. The company aims to innovate and improve patient quality of life through its drug development initiatives.

Positive

• New corporate identity aligns with the company's mission to provide hope for patients.
• FDA acknowledgment allows initiation of pivotal Phase 3 study for Trappsol® Cyclo™.
• Encouraging data supports the use of Trappsol® Cyclo™ for late-onset Alzheimer's Disease.

Negative

• None.

Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company developing cyclodextrin-based products for the treatment of Niemann-Pick Disease Type C and Alzheimer’s Disease, today unveiled its new corporate identity, which is intended to emphasize the Company’s commitment to improving quality of life, providing hope for patients and families through innovative life-changing medicine, and bringing awareness that we are all in this together.

“This coming Sunday, February 28^th, is Rare Disease Day, an event meant to bring attention and hope to patients and families suffering from devastating and rare diseases, and who are left without treatment options,” commented N. Scott Fine, CEO of Cyclo Therapeutics. “In recognition of Rare Disease Day, we reaffirm our commitment to patients and families. Our re-branding reflects an identity in line with our mission and vision to bring hope to patients and families in indications where there remains significant unmet medical need.”

Mission:

Dedicated to developing life-changing medicines through science and innovation for patients and families suffering from disease.

Vision:

Providing hope through patient-focused drug development to improve quality of life.

The Company’s lead product in development, Trappsol^® Cyclo™, is a proprietary formulation of hydroxypropyl beta cyclodextrin used intravenously (IV). Trappsol^® Cyclo™ is currently in development for the treatment of NPC1, a rare genetic disorder causing cholesterol accumulation in lysosomes of cells, organ dysfunction and premature death. Functioning like the NPC1 protein, Trappsol^® Cyclo™ has been shown to transport cholesterol out of cells, normalizing cholesterol metabolism. Following review of the Company’s Phase 1 and Phase 1/2 data, coupled with preclinical and compassionate use data, regulatory authorities acknowledged that IV hydroxypropyl beta cyclodextrin has the potential to treat systemic and neurologic manifestations of NPC and has the capacity when given intravenously to be a preventative treatment. The Company received FDA acknowledgment that the pivotal Phase 3 study may begin, and enrollment is targeted to commence in Q2 2021.

Additionally, based on encouraging data from an Expanded Access program for late-onset Alzheimer’s Disease, the Company is planning to initiate an early phase clinical trial evaluating the use of Trappsol^® Cyclo™ intravenously for the treatment of Alzheimer’s Disease.

For more information about the Cyclo Therapeutics and its pipeline of products in development, please visit: www.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, (ClinicalTrials.gov NCT02939547, NCT02912793 and NCT02912793). 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/20210222005186/en/

FAQ

What is Cyclo Therapeutics' main product and its application?

Cyclo Therapeutics' main product is Trappsol® Cyclo™, used for treating Niemann-Pick Disease Type C and late-onset Alzheimer’s Disease.

When is the enrollment for Cyclo Therapeutics' Phase 3 study expected to begin?

Enrollment for the Phase 3 study is targeted to commence in Q2 2021.

What does the new corporate identity of Cyclo Therapeutics signify?

The new corporate identity reflects Cyclo Therapeutics' commitment to improving the quality of life for patients with rare diseases.

What regulatory recognition has Cyclo Therapeutics received?

Cyclo Therapeutics received FDA acknowledgment regarding the potential initiation of their pivotal Phase 3 study for NPC1.