Ongoing progress toward last patient enrolled in pivotal Phase 3 study (“TransportNPC™”) evaluating Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C1 (NPC1), expected Q2 2024

Topline data from 48-week interim analysis expected H1 2025

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 reported its financial results for the first quarter 2024 and provided a business update.

“We continue to make progress toward the completion of patient enrollment in our ongoing TransportNPC™ trial. Coupled with our alignment with the FDA on our regulatory path forward, we are focused on the interim data readout expected in Q1 2025 and generating potentially meaningful data required to drive our TransportNPC™ study across the finish line. We can’t thank the NPC community enough for their continued support in working with us in advancing the study of Trappsol® Cyclo™ as a potential treatment to all living with NPC,” commented N. Scott Fine, CEO of Cyclo Therapeutics.

Recent Highlights

  • Granted U.S. patent covering use of Trappsol® Cyclo™ for treatment of Alzheimer's Disease from the U.S. Patent and Trademark Office.

Summary of Financial Results for the First Quarter 2024

Net loss for the quarter ended March 31, 2024 was approximately $4.3 million. Research and development expenses decreased 16% to $2.8 million for the quarter ended March 31, 2024, from $3.4 million for the quarter ended March 31, 2023. The decrease in research and development expense resulted from the reduction of spending related to the Alzheimer’s program and adjustments to research and development personnel cost allocations as projects progress to clinical trials.

The Company ended the quarter with approximately $2.9 million of cash.

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® 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 C1, a rare and fatal genetic disease, (NCT02939547, NCT02912793, NCT03893071 and NCT04860960). The Company is conducting a Phase 2b clinical trial using Trappsol® Cyclo™ 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® 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.

Investor Contact: JTC Team, LLC Jenene Thomas (833) 475-8247 CYTH@jtcir.com

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