News

Cyclo Therapeutics Provides Business Update and Reports First Quarter 2023 Financial Results

May 15, 2023

  • Company on track to complete enrollment in ongoing pivotal Phase 3 global study (TransportNPC™) evaluating Trappsol® Cyclo™ for Niemann-Pick Disease Type C1 (NPC1) by year end 2023

GAINESVILLE, Fla. –
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 of 2023 and provided a business update.

“We continued to execute both clinically and operationally last quarter. We remain on track to be fully enrolled in our Transport NPC study by the end of the year and 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. In addition, we received continued support financially from our board of directors and welcomed strategic investor Rafael Holdings in two successful fund raises completed following the end of the quarter. Our commitment to the NPC community remains steadfast and strong; we are here with you,” commented N. Scott Fine, CEO of Cyclo Therapeutics.

Recent Highlights

  • TransportNPC™ pivotal study on track to be 50% enrolled by the end of May 2023; Company on track to complete enrollment by year end;

  • Completed financings with gross proceeds totaling $7.7 million, with participation by the Company’s Board and Management, and a strategic investment by Rafael Holdings, Inc. (NYSE: RFL);

  • Appointed global pharmaceutical and biotechnology commercialization leader, William Conkling, Rafael’s Chief Executive Officer, to the Board of Directors of Cyclo Therapeutics; and

  • Commenced Phase 2b study of Trappsol® Cyclo™ for the treatment of early Alzheimer’s Disease.

Summary of Financial Results for the First Quarter 2023

Net loss for the quarter ended March 31, 2023 was approximately $5.0 million. Research and development expenses increased 213% to $3.4 million for the quarter ended March 31, 2023, from $1.1 million for the quarter ended March 31, 2022. The changes in research and development expenses relate to the increased activity in the Company’s Phase 3 study of Trappsol® Cyclo™ for the treatment of NPC. The Company expects research and development costs to increase in 2023 as Cyclo Therapeutics continues to seek regulatory approval for the use of Trappsol® Cyclo™ in the treatment of NPC and Alzheimer’s disease.

The Company ended the quarter on a pro forma basis with approximately $3.0 million of cash, after giving effect to the recent financings.

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 C, a rare and fatal genetic disease, (www.ClinicalTrials.gov 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.

JTC Team, LLC

Jenene Thomas

(833) 475-8247

CYTH@jtcir.com

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Trappsol® Cyclo™ is not currently approved for any indication.

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