Cyclo Therapeutics Reports Second Quarter 2023 Financial Results

Rhea-AI Summary

Cyclo Therapeutics reports strong enrollment progress in pivotal Phase 3 study for Niemann-Pick Disease Type C1

Positive

• Continued strong enrollment in pivotal Phase 3 study
• Anticipates achieving 60% enrollment by end of August
• Extended cash runway with $5.0 million private placement

Negative

• Net loss of approximately $4.6 million for Q2 2023
• Research and development expenses increased by 69%

Continued strong enrollment of pivotal Phase 3 global study (TransportNPC™) evaluating Trappsol^® Cyclo™ for Niemann-Pick Disease Type C1 (NPC1) on track to complete enrollment by year end 2023

Company anticipates achieving 60% of enrollment of TransportNPC™ by end of August

Topline results from TransportNPC™ expected Q4 2024

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 reported its financial results for the second quarter 2023.

“Over the past quarter, we continued to execute on all fronts. We remain focused on driving recruitment in our pivotal TransportNPC™ study of Trappsol^® Cyclo^™ and are on track to complete enrollment by the end of this year. Our commitment to the NPC community remains steadfast, strong and a top priority. We are working diligently to bring a safe and effective treatment option where there remains a significant unmet need,” commented N. Scott Fine, Chief Executive Officer of Cyclo Therapeutics.

Recent Highlights

• Extended cash runway with the closing of a $5.0 million private placement with strategic investor, Rafael Holdings, Inc. (NYSE: RFL);
• Continued prioritization on patient engagement and advocacy through participation at the 2023 NNPDF Family Support & Medical Conference and China NPC meeting to connect with the global NPC community and discuss Trappsol^® Cyclo™ and its clinical development program for the treatment of NPC;
• Announced the publication of positive, confirmatory data from its Phase 1/2 clinical trial, which demonstrated promising safety and efficacy results for Trappsol^® Cyclo^™ in the treatment of Niemann-Pick Disease Type C1; and
• Received allowance of patent from European Patent Office for Trappsol^® Cyclo^™ for Alzheimer’s Disease.

Summary of Financial Results for the Second Quarter 2023

Net loss for the quarter ended June 30, 2023 was approximately $4.6 million. Research and development expenses increased 69% to approximately $3.2 million for the three months ended June 30, 2023, from approximately $1.9 for the three months ended June 30, 2022. The increase in research and development expense resulted from the increased activity in our Phase 3 study of Trappsol^® Cyclo™ for the treatment of NPC in the more recent period. We expect research and development costs to increase in 2023 as we continue to seek regulatory approval for the use of Trappsol^® Cyclo™ in the treatment of NPC and Alzheimer’s disease.

The Company ended the quarter with approximately $0.8 million of cash. Subsequent to quarter-end, the Company generated gross proceeds of $5.0 million from the sale of securities in private placements of the Company’s securities.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230815452049/en/

Investor Contact:

JTC Team, LLC

Jenene Thomas

(833) 475-8247

CYTH@jtcir.com

Source: Cyclo Therapeutics, Inc.

What is the progress of Cyclo Therapeutics' pivotal Phase 3 study for Niemann-Pick Disease Type C1?

The enrollment in the study is continuing strongly and is expected to be completed by the end of 2023.

What is the company's enrollment target by the end of August?

The company anticipates achieving 60% enrollment of the study by the end of August.

How did Cyclo Therapeutics extend its cash runway?

Cyclo Therapeutics closed a $5.0 million private placement with strategic investor Rafael Holdings, Inc.

What were the financial results for the second quarter of 2023?

The net loss for the quarter was approximately $4.6 million, and research and development expenses increased by 69%.

What is the company's plan for research and development costs?

Research and development costs are expected to increase in 2023 as the company seeks regulatory approval for the use of Trappsol Cyclo in the treatment of NPC and Alzheimer's disease.