– Quarter marked by launch of Phase 2b study of Trappsol® Cyclo™ for the treatment of early Alzheimer’s Disease (AD) with patient enrollment and site activation now underway
– Building momentum with ongoing advancement of global pivotal study (TransportNPC™) evaluating Trappsol® Cyclo™ for Niemann-Pick Disease Type C1 (NPC1)
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 third quarter of 2022 and highlighted recent achievements.
“We have continued to execute and make significant progress on our clinical programs evaluating Trappsol® Cyclo™ for the treatment of NPC and early Alzheimer’s disease. Over the past quarter, our team continued our global engagement within the NPC community by participating at conferences, which we believe are a key component of our mission, as we work to bring a safe and effective treatment option,” commented N. Scott Fine, CEO of Cyclo Therapeutics. “Importantly, we achieved a noteworthy milestone with the recent commencement of our Phase 2b study evaluating Trappsol® Cyclo™ for the treatment of early AD and are on track to commence patient dosing before year end. The dedication of our team and clinical sites is a testament to the potential of Trappsol® Cyclo™ and the urgent need for an innovative treatment option.”
Recent Corporate Highlights
- Announced the publication of Phase 1 data for Trappsol® Cyclo™ for the treatment of NPC in the official journal of the Society for Inherited Metabolic Disorders, Molecular Genetics and Metabolism;
- Commenced its Phase 2b study of Trappsol® Cyclo™ for the treatment of early AD, targeting the reduction of amyloid beta and tau; and
- Attended the 2022 NPUK Annual Family Conference & Interactive Workshop on Niemann-Pick Disease with Caroline Hastings, M.D., Key Opinion Leader in NPC and Global Principal Investigator for the ongoing TransportNPC™ study, to connect with the global NPC community and discuss Trappsol® Cyclo™ and its clinical development program for the treatment of NPC.
Summary of Financial Results for Third Quarter 2022
Net loss for the quarter ended September 30, 2022 was approximately $4.2 million. Research and development expenses increased 55% to approximately $2.9 million for the three months ended September 30, 2022, from $1.8 million for the three months ended September 30, 2021. The increase in research and development expense in the more recent period was related to the timing of startup, site initiation and enrollment costs in our clinical programs. The Company expects research and development to further increase in 2022 as we continue to seek regulatory approval for the use of Trappsol® Cyclo™ in the treatment of NPC and Alzheimer’s disease.
The Company ended the quarter with approximately $4.3 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 C, 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.
Contacts
Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
CYTH@jtcir.com