Cyclo Therapeutics Q1 2024 Financial Results and Business Update

Cyclo Therapeutics, Inc., a clinical-stage biotechnology firm listed on Nasdaq under the ticker CYTH, recently shared its financial performance for the first quarter of 2024 and provided significant updates on its ongoing projects aimed at combatting rare diseases.

The company continues to make strides in its pivotal Phase 3 study, known as TransportNPC™, which evaluates the efficacy of Trappsol® Cyclo™ for treating Niemann-Pick Disease Type C1 (NPC1). Cyclo Therapeutics expects to complete patient enrollment in this critical study by the second quarter of 2024. The 48-week interim analysis of the study is anticipated to yield topline data by the first half of 2025. N. Scott Fine, the company's CEO, expressed gratitude to the NPC community for their ongoing support, emphasizing the collaborative effort with the FDA and the importance of the interim data readout expected in early 2025.

In addition to advancements in the NPC1 study, Cyclo Therapeutics has also achieved a notable milestone by securing a U.S. patent for the use of Trappsol® Cyclo™ in treating Alzheimer's Disease. This patent was granted by the U.S. Patent and Trademark Office, marking a significant step forward in the company's efforts to expand the potential applications for its flagship product.

Financially, Cyclo Therapeutics reported a net loss of approximately $4.3 million for the first quarter ending March 31, 2024. This marks a continued investment in research and development, although expenses in this area saw a reduction of 16%, amounting to $2.8 million compared to $3.4 million in the same quarter the previous year. The decrease in research and development spending was attributed to reduced costs associated with the Alzheimer's program and the reallocation of personnel costs as various projects advance towards clinical trials. By the end of the quarter, the company had approximately $2.9 million in cash reserves.

Cyclo Therapeutics is committed to creating transformative medicines through scientific innovation, focusing on unmet medical needs. Trappsol® Cyclo™, which has orphan drug designation in both the U.S. and Europe, is currently being tested in four clinical trials aimed at treating Niemann-Pick Disease Type C1, a severe and often fatal genetic disorder. These trials are registered under the following numbers: NCT02939547, NCT02912793, NCT03893071, and NCT04860960.

Furthermore, the company is conducting a Phase 2b clinical trial utilizing Trappsol® Cyclo™ for early Alzheimer's Disease (NCT05607615). This decision was based on promising results from an Expanded Access program for Alzheimer's (NCT03624842). Beyond these indications, Cyclo Therapeutics is also exploring additional potential uses for the active ingredient in Trappsol® Cyclo™.

In summary, Cyclo Therapeutics is advancing its clinical trials and regulatory pathways with the aim of providing new therapeutic options for those affected by challenging diseases like NPC1 and Alzheimer's. The company's recent financial results reflect ongoing investments in this mission, with a clear focus on achieving meaningful data from upcoming interim analyses and continuing to work closely with regulatory bodies and patient communities.