Cyclo Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

By: Cyclo Therapeutics, Inc. via Business Wire

March 18, 2024 at 09:05 AM EDT

Continued progress of pivotal Phase 3 study (TransportNPC™) evaluating Trappsol^®Cyclo™ for the treatment of Niemann-Pick Disease Type C1 (NPC1) toward 48-week comparative interim analysis data readout, planned for Q1 2025

Aligned development strategy for Trappsol^®Cyclo™ with FDA to enable a patient population lacking available therapies to have earlier access to a potentially efficacious product with an acceptable safety profile

Ended the year with approximately $9.2 million cash to fund operations; continued efforts to bolster cash position and extend runway through clinical and regulatory milestones

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 full year 2023 and provided a business update.

“We made significant progress over the course of the past year. We continue to be extremely active with the NPC patient and scientific communities and believe these valuable interactions underscore the progress we have seen with the advancement of our TransportNPC study,” commented N. Scott Fine, Chief Executive Officer of Cyclo Therapeutics. “Following the completion of the merger with Applied Molecular Transport, we are poised to continue building momentum and achieving the value-driving milestones ahead. Importantly, supported with the positive feedback from FDA and alignment on our strategy moving forward, we remain focused on generating the appropriate data required to successfully drive our TransportNPC study across the finish line and the potential to provide a much-needed treatment option for the NPC community. We are grateful for the continued support of our investors, including Rafael Holdings and other longtime shareholders, who have bolstered our cash runway and helped position us to achieve our mission and continue our work to advance the clinical development of Trappsol^®Cyclo™.”

William Conkling, Chief Executive Officer of Rafael Holdings, Inc., added, “We are pleased with the continued clinical progress and operational execution and look forward to the continued advancement of those efforts in 2024.”

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;
Completed merger with Applied Molecular Transport Inc to focus on advancing Cyclo Therapeutics’ pivotal Phase 3 global study, TransportNPC™, evaluating Trappsol^® Cyclo™ for NPC;
Dr. Caroline Hastings, Chair of the Company’s Phase 3 Trappsol^®Cyclo™ program steering committee and Global Principal Investigator for the Company’s ongoing TransportNPC™ study presented at the 20^thAnnual WORLDSymposium™; and
Announced positive outcome from Type C Meeting with the U.S. FDA discussing Trappsol^®Cyclo™ clinical program for the treatment of Niemann-Pick Disease Type C1.
Strengthened Balance Sheet with early exercise of warrants by board members, management and a significant shareholder resulting in bolstered cash proceeds of $2.4 million. The Investors include Rafael Holdings, Inc., a significant shareholder of the Company, several directors of the Company, Company management, and their affiliates.

Summary of Financial Results for the Full Year 2023

Net loss for the year ended December 31, 2023 was approximately $20.1 million. Research and development expenses increased 58% to $14.2 million for the year ended December 31, 2023, from $9.0 million for the year ended December 31, 2022. The changes in research and development expenses resulted from the increased activity in the Company’s Phase 3 study of Trappsol^®Cyclo™ for the treatment of NPC.

The Company ended the year with approximately $9.2 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, (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.