Cyclo Therapeutics Names Preeminent Neuroscientist and World-Renowned Researcher, Cynthia A. Lemere, PhD, as Senior Advisor for Advancement of Alzheimer’s Disease Asset

Rhea-AI Summary

Cyclo Therapeutics has appointed Dr. Cynthia A. Lemere as Senior Advisor for its Alzheimer’s disease program. Dr. Lemere, known for her contributions to Alzheimer’s research, focuses on using the immune system for therapeutic approaches. The company plans to advance Trappsol® Cyclo™ towards a Phase 2 study for Alzheimer’s, with an IND filing expected before year-end 2021. Cyclo Therapeutics received positive FDA feedback on its development strategy, indicating strong support for its research in addressing significant unmet medical needs in Alzheimer’s treatment.

Positive

• Appointment of Dr. Cynthia A. Lemere enhances the expertise of Cyclo Therapeutics in Alzheimer’s research.
• Positive feedback from the FDA supports the strategy for advancing Trappsol® Cyclo™ to Phase 2 study.
• Trappsol® Cyclo™ shows encouraging results in pre-clinical studies and compassionate use programs.

Negative

• None.

– Dr. Lemere is a renowned translational researcher focused on understanding, preventing, and treating Alzheimer’s disease

– Company continues to advance evaluation of Trappsol^® Cyclo™ toward Phase 2 study in Alzheimer’s disease with investigational new drug application (IND) filing on track before year end

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 announced the appointment of Cynthia A. Lemere, PhD as Senior Advisor for its Alzheimer’s disease program.

Dr. Lemere is a distinguished scientist who currently serves in the Ann Romney Center for Neurologic Diseases at Brigham and Women's Hospital (BWH) and as Associate Professor of Neurology at Harvard Medical School in Boston. She was a pioneer in the field of using antibodies against amyloid-beta for the prevention or treatment of Alzheimer's disease. Beginning in 1997, her research laboratory has focused on the role of inflammation and the immune system in the onset of Alzheimer's disease, paving the way for identification of drug development targets to prevent or treat Alzheimer’s disease. Her laboratory is funded by the National Institutes of Health (NIH), NASA, and private foundations. Dr. Lemere has served as a mentor to numerous doctoral and post-doctoral students, helping to build the next generation of leaders in Alzheimer’s Disease, and she is a highly sought-after advisor to public sector and private groups.

“There remains significant unmet medical need in the treatment of this devastating disease. As we continue to advance the evaluation of Trappsol^® Cyclo™ for the treatment of Alzheimer’s disease, we are pleased to welcome Dr. Lemere to the team. Her research and groundbreaking contributions to understanding and using the immune system therapeutically to prevent and treat Alzheimer’s disease is a valuable asset that we believe will provide insightful perspective as we work to enter a Phase 2 study in this disease and advance this critical program,” commented Lise Lund Kjems, MD, PhD, Chief Medical Officer of Cyclo Therapeutics.

“Dr. Lemere is a highly recognized and well-established Thought Leader in Alzheimer’s disease research. Her leadership, expertise, and passion are noteworthy additions to Cyclo Therapeutics, and they are in-line with our own dedication to helping patients and families suffering from this insidious disease. We continue to be encouraged by the potential of Trappsol^® Cyclo™ and look forward to furthering its development for Alzheimer’s disease,” added Sharon Hrynkow, PhD, Chief Scientific Officer, Senior Vice President of Medical Affairs of Cyclo Therapeutics.

Dr. Lemere’s current research involves non-clinical studies of antibody treatments targeting a pathogenic form of amyloid-beta protein in Alzheimer’s disease; the role of complement signaling in aging and Alzheimer’s disease; and the effects of deep space galactic cosmic radiation on brain aging and the risk of Alzheimer’s disease in studies in mouse models and human neural cells in preparation for NASA’s first manned mission to Mars in the 2030s. She is a member and the past chair of the Alzheimer’s Association’s Medical and Scientific Advisory Group and a former member of the Association’s Board of Directors. She is also a member of the Cure Alzheimer’s Fund Research Leadership Group. In addition, she serves as a scientific advisor for several foundations, conferences and companies.

“Physicians and families within the Alzheimer’s disease community continue to be faced with significant unmet medical needs. I believe the positive results that have been demonstrated by Trappsol Cyclo/beta cyclodextrins to date in pre-clinical studies and the Company’s compassionate use program are encouraging and reaffirm furthering its development. I’m excited to join this dedicated team to help advance the development of Trappsol Cyclo for the treatment of Alzheimer’s disease as quickly and efficiently as possible,” added Dr. Lemere.

Dr. Lemere earned a bachelor’s degree in psychology and education from Mount Holyoke College and a master’s in neurobiology from SUNY Albany. She then went on to examine Alzheimer's-related brain changes in people with Down syndrome in the Selkoe Laboratory at BWH while pursuing her doctorate in Pathology at Boston University School of Medicine. After receiving her Ph.D., she remained at the BWH Ann Romney Center for Neurologic Diseases within the Department of Neurology where she is an associate professor.

Cyclo Therapeutics is planning to evaluate Trappsol^® Cyclo™, the company’s proprietary formulation of hydroxypropyl beta cyclodextrin, for the treatment of Alzheimer’s disease, targeting the reduction of amyloid beta and tau. As part of a Type B interaction with the FDA, Cyclo Therapeutics received positive feedback supporting the Company’s 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 before year-end 2021.

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 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/20211102005730/en/

Investor Contact:

JTC Team, LLC

Jenene Thomas

(833) 475-8247

CYTH@jtcir.com

Source: Cyclo Therapeutics, Inc.

FAQ

What is the significance of Dr. Cynthia A. Lemere's appointment at Cyclo Therapeutics?

Dr. Cynthia A. Lemere's appointment as Senior Advisor brings significant expertise to Cyclo Therapeutics, enhancing its Alzheimer's program and research capabilities.

What is Cyclo Therapeutics planning for Trappsol® Cyclo™?

Cyclo Therapeutics plans to advance Trappsol® Cyclo™ towards a Phase 2 study for Alzheimer’s disease, with an IND filing expected before year-end 2021.

What feedback did Cyclo Therapeutics receive from the FDA?

Cyclo Therapeutics received positive feedback from the FDA regarding its development strategy for Trappsol® Cyclo™, supporting its advancement to clinical trials.

What are the potential benefits of Trappsol® Cyclo™ for Alzheimer’s patients?

Trappsol® Cyclo™ has shown encouraging results in pre-clinical studies, indicating potential therapeutic benefits for Alzheimer’s patients.

How is Cyclo Therapeutics addressing unmet medical needs in Alzheimer’s treatment?

Cyclo Therapeutics aims to address unmet medical needs in Alzheimer’s treatment through the development of Trappsol® Cyclo™, focusing on innovative therapies and advanced research.