Quarter marked by achievement of landmark milestone with completion of enrollment in pivotal Phase 3 study (“TransportNPC™”) evaluating Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C1 (NPC1)
Topline data from the 48-week interim analysis of 104 enrolled patients in TransportNPC™ on track for H1 2025
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 second quarter 2024 and provided a business update.
“The second quarter represents a transformative time for the Company with the achievement of a landmark milestone — the completion of enrollment in our pivotal TransportNPC™ trial. I am extremely pleased with the progress our entire team has made with this important program. Equipped with the positive support, feedback and alignment from our recent health authority interactions with both the FDA and EMA coupled with the completion of enrollment, we are highly focused on the interim data readout expected in Q1 2025. What this means is that we believe we will be generating the data required to provide a much-needed treatment option for the treatment of NPC1,” commented N. Scott Fine, CEO of Cyclo Therapeutics.
Recent Highlights
- Achieved completion of enrollment in Phase 3 Pivotal TransportNPC™ Trial of Niemann-Pick Type C1. If 48-week data demonstrate significance, submission of New Drug Application (NDA) to the Food and Drug Administration (FDA) and Marketing Authorization Application (MAA) to European Medicines Agency (EMA) is targeted for 2H 2025; Qualification for Priority Review Voucher (PRV) upon NDA submission;
- Continued NPC community engagement through attendance at the Latin American School of Medical and Human Genetics Annual Meeting (ELAG), Australian NPC Foundation Conference, and NNPDF Family Support & Medical Conference;
- Announced two abstracts have been accepted for poster presentation at the SSIEM Annual Symposium 2024 being held September 3-6, 2024, in Porto, Portugal; and
- Received a notice from the European Patent Office of a decision to grant European patent application No. 19805439.7 titled, “Methods for Treating Alzheimer’s Disease” under European patent number 3873604B. The notice states that mention of the decision will be published on August 21, 2024 in European Patent Bulletin 24/34 and will take effect on that date.
Summary of Financial Results for the Second Quarter 2024
Net loss for the quarter ended June 30, 2024 was approximately $6.0 million. Research and development expenses increased 10% to $3.5 million for the quarter ended June 30, 2024, from $3.2 million for the quarter ended June 30, 2023. The increase in research and development expense resulted from the increase of spending related to the completion of enrollment of 94 patients in the NPC program.
The Company ended the quarter with approximately $1.1 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.
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