Cyclo Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update

Rhea-AI Summary

Cyclo Therapeutics (Nasdaq: CYTH) reported its Q1 2024 financial results, highlighting ongoing progress in its TransportNPC™ Phase 3 study for Niemann-Pick Disease Type C1 (NPC1). The study expects to enroll the last patient by Q2 2024, with topline data anticipated in H1 2025. The company also received a U.S. patent for using Trappsol® Cyclo™ to treat Alzheimer's Disease.

Financially, Cyclo Therapeutics reported a net loss of $4.3 million for Q1 2024. However, research and development expenses decreased by 16% to $2.8 million due to reduced spending on the Alzheimer’s program and adjustments in personnel costs. The company ended the quarter with $2.9 million in cash.

Cyclo Therapeutics focuses on developing life-changing medicines, with Trappsol® Cyclo™ in multiple clinical trials for NPC1 and early Alzheimer’s disease.

Positive

• Ongoing Phase 3 study TransportNPC™ progressing towards completing patient enrollment by Q2 2024.
• Topline data from the 48-week interim analysis expected in H1 2025.
• Granted U.S. patent for Trappsol® Cyclo™ for Alzheimer's Disease treatment.
• Research and development expenses decreased by 16% compared to the same period last year.
• Continued support from the NPC community.

Negative

• Net loss of $4.3 million for Q1 2024.
• Company ended Q1 2024 with reduced cash reserves of $2.9 million.
• Reduction in Alzheimer's program spending and adjustments in personnel costs.

Insights

Financial Analyst

The reported net loss of approximately $4.3 million for the quarter ended March 31, 2024, indicates a significant shortfall. This is a substantial number and could impact investor sentiment negatively, particularly for those focused on financial stability. However, it's worth noting the 16% decrease in research and development expenses, down to $2.8 million from $3.4 million in the same quarter of the previous year. This reduction suggests better operational efficiency, which might be a positive sign. However, the company’s cash reserve of $2.9 million is relatively low for a clinical-stage biotech, raising concerns about future capital requirements and potential dilution if additional financing is sought. Investors need to weigh the potential of their ongoing clinical trials against the company's financial health.

Medical Research Analyst

Cyclo Therapeutics' ongoing Phase 3 study for Niemann-Pick Disease Type C1 and the upcoming interim data readout expected in H1 2025 are key milestones. Phase 3 trials are critical in the drug development process and their results heavily influence regulatory decisions. The successful enrollment and upcoming data are particularly significant given the orphan drug status of Trappsol® Cyclo™. Yet, the timeline indicates a long wait before data becomes available, which factors into the investment horizon. Furthermore, the recent patent grant for use in Alzheimer’s disease adds another potential avenue for future revenue, but this is still in early trial phases. The dual focus on NPC and Alzheimer's could diversify risk but also stretch resources.

Market Research Analyst

The company’s alignment with the FDA on regulatory pathways is a critical aspect. For biotech firms, regulatory support often predicates market success. The clear path with the FDA could expedite the drug approval process, particularly for rare diseases like NPC1. However, the market for rare disease treatments is small, implying limited commercial upside without successful expansion into more common conditions like Alzheimer's. Additionally, the decrease in R&D expenses due to shifting focus might indicate strategic prioritization but also potential deprioritization or delays in other projects. Investors need to consider these strategic moves in the context of overall market potential and company focus.

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

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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240516607086/en/

Investor Contact:

JTC Team, LLC

Jenene Thomas

(833) 475-8247

CYTH@jtcir.com

Source: Cyclo Therapeutics, Inc.

FAQ

What progress has Cyclo Therapeutics made in its Phase 3 TransportNPC™ study?

Cyclo Therapeutics expects to enroll the last patient in its Phase 3 TransportNPC™ study by Q2 2024, with topline data anticipated in H1 2025.

What were Cyclo Therapeutics' financial results for Q1 2024?

Cyclo Therapeutics reported a net loss of $4.3 million for Q1 2024, with research and development expenses decreasing by 16% to $2.8 million.

What is the cash position of Cyclo Therapeutics as of Q1 2024?

Cyclo Therapeutics ended Q1 2024 with approximately $2.9 million in cash.

What recent patent did Cyclo Therapeutics receive?

Cyclo Therapeutics was granted a U.S. patent for the use of Trappsol® Cyclo™ in the treatment of Alzheimer's Disease.