Strategic merger with Rafael Holdings to combine two companies and advance Trappsol® Cyclo™ for NPC1 patients expected to close Q4 2024
Company on track for topline data from the 48-week interim analysis of 104 enrolled patients in TransportNPC™ in H1 2025
Submission of New Drug Application (NDA) to the Food and Drug Administration (FDA) and Marketing Authorization Application (MAA) to European Medicines Agency (EMA) targeted for H2 2025
Qualification for Priority Review Voucher expected upon NDA submission
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 third quarter 2024 and provided a business update.
“The third quarter has been marked by important advancements on our clinical and corporate fronts. We are poised to complete our TransportNPC™ study next year and believe the findings most recently presented at the SSIEM Symposium further emphasize the potential of Trappsol® Cyclo™ to provide a transformational impact for all people living with NPC,” commented N. Scott Fine, CEO of Cyclo Therapeutics. “Furthermore, the merger with Rafael Holdings is a crucial step forward in our overall strategy and commitment to unlock the full potential of the TransportNPC™ trial for our shareholders and most importantly, the NPC community globally.”
Recent Highlights
- Entered into a definitive merger agreement with Rafael Holdings to combine the two companies to focus on the development of Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C1. The merger is expected to close before year-end 2024.
- Achieved completion of enrollment in Phase 3 pivotal TransportNPC™ trial of Niemann-Pick Type C1. If 48-week data demonstrate significance, submission of NDA to FDA and MAA to EMA is targeted for 2H 2025.
- Received qualification for Priority Review Voucher upon NDA submission.
- Presented positive preliminary data from ongoing pivotal Phase 3 TransportNPC™ trial and substudy evaluating Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C1 in two poster presentations at the SSIEM Annual Symposium 2024 that was held in Porto, Portugal.
- 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.
Summary of Financial Results for the Third Quarter 2024
Net loss for the quarter ended September 30, 2024 was approximately $8.8 million. Research and development expenses increased 57% to approximately $5.5 million for the three months ended September 30, 2024, from approximately $3.5 for the three months ended September 30, 2023.
The Company ended the quarter with approximately $0.9 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.
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