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Cyclo Therapeutics Enters Research and Collaboration Agreement with Wits Commercial Enterprise (Pty) Ltd to Explore Potential Applications of Trappsol® Cyclo™ to Expand Pipeline

– Collaboration with the University of the Witwatersrand, Johannesburg (“Wits”), represented by Wits Commercial Enterprise; a wholly-owned subsidiary of the University mandated to manage and commercialize the University’s Intellectual Property; expected to explore the University’s proprietary platform technology in various indications.

– Company currently advancing Trappsol® Cyclo™ in a pivotal Phase 3 study for the treatment of Niemann-Pick Disease Type C and planned Phase 2 study for the treatment of early Alzheimer’s disease.

Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a late clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today announced that it has entered into a research and collaboration agreement with the University of the Witwatersrand, Johannesburg (Wits) represented by Wits Commercial Enterprise (Pty) Ltd, a wholly owned subsidiary of the University whose mandate is to protect and manage the University’s intellectual property. Under the terms of the collaboration agreement, Wits and Cyclo Therapeutics plan to develop and coordinate projects or activities to further scientific advancement of the Company’s proprietary platform technology, Trappsol® Cyclo™.

N. Scott Fine, Chief Executive Officer of Cyclo Therapeutics commented, “We have established proof-of-concept and compelling data to-date with Trappsol® Cyclo™ and currently have a Phase 3 study in Niemann-Pick Disease Type C underway, and are preparing to advance our Phase 2 study in Alzheimer’s disease. This growing body of encouraging data, combined with our unique mechanism of action facilitated an exciting dialogue with Wits and warrants pursuing together further applications of our technology in additional indications. This collaboration is an important strategic step forward in understanding the potential and expected broad utility of our validated platform technology. We believe working with Wits, a world-renowned teaching, research and development institution, will enable us to explore the depth and breadth of our pipeline opportunities with Trappsol® Cyclo™ as well as bolster our growing intellectual property estate. We look forward to working with the Wits team to advance this technology and provide what we believe will be a solid foundation to fuel a robust pipeline.”

Prof Mandeep Kaur of Wits’ School of Molecular and Cell Biology commented, “The collaboration with Cyclo Therapeutics is an exciting milestone in our endeavors to develop innovative and groundbreaking treatment for various disease indications based on our proof-of-concept studies concluded in the past few years. This complementarity of skills and experience will facilitate new knowledge generation for the benefit of science and humanity, signifying the true spirit of Ubuntu. We believe that our collaboration with a progressive company like Cyclo Therapeutics will enhance our capability to explore complex disease related pathways while translating impactful research to clinics in the future. We are delighted to have Cyclo Therapeutics on-board during our therapeutics discovery and innovation journey.”

The Collaboration consists of cooperative agreements in specific, undisclosed research and development, technology development and commercialization, and training projects, or any other activity agreed upon by Cyclo Therapeutics and Wits. Due to intellectual property development and for competitive reasons, Cyclo Therapeutics is not disclosing details related to the exploration of therapeutic areas or indications at this time.

“Wits Enterprise is a world-class organization and the go-to platform for Wits researchers needing support to capitalize their knowledge and research. We are excited to utilize and leverage their deep knowledge and expertise to further the advancement of Trappsol® Cyclo™ and its potential to address additional areas of unmet clinical need,” added Lise Lund Kjems, MD, PhD, Chief Medical Officer of Cyclo Therapeutics.

Trappsol® Cyclo™ is a proprietary formulation of hydroxypropyl beta cyclodextrin that, in multiple clinical studies, has shown encouraging results to effectively manage the transportation of cholesterol. Taking the place of the defective NPC1 protein, Trappsol® Cyclo™, with its cyclic structure, facilitates the transport of accumulated cholesterol out of cellular lysosomes so it can be further processed and excreted out of cells.

Cyclo Therapeutics is currently testing the investigational Trappsol® Cyclo™ drug in a pivotal Phase 3 clinical trial and a long-term extension study for the treatment of Niemann-Pick disease Type C1, a rare, fatal and progressive genetic disorder and for the treatment of Alzheimer’s disease, an irreversible, progressive neurological disorder, in which high cholesterol is also implicated as a risk factor.

About Wits University

The University of the Witwatersrand is a leading research-intensive university in Africa, renowned for its academic and research excellence, and its commitment to social justice and the advancement of the public good. Located in Johannesburg (South Africa), the economic and industrial heartland of Africa, Wits University is committed to furthering its contribution to delivering high-level scarce skills for the global knowledge economy and building partnerships that will have a positive impact on society.

About Wits Enterprise

Wits Enterprise is a private company, wholly owned by the University of the Witwatersrand in South Africa. The company is mandated to promote and commercialize Wits’ intellectual capital, research and innovations, so as to broaden and deepen Wits’ impact on society. Wits Commercial Enterprise comprises three units which each provide dedicated and strategic services that are aligned with the objective to optimize the University’s impact. These include Innovation Support, Research Support and Consulting, and Short Courses and Management Consulting.

About Cyclo Therapeutics

Cyclo Therapeutics, Inc. is a late 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 being studied in a Phase 3 pivotal clinical trial for Niemann-Pick Disease Type C, a rare and fatal genetic disease, ( NCT02939547, NCT02912793, NCT03893071 and NCT04860960). The Company is planning a Phase 2 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:

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.


Investor Contact:


Jenene Thomas

(833) 475-8247

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