– Multiple value-driving milestones expected throughout 2021
– Trappsol® Cyclo™ Niemann Pick Disease Type C (NPC) clinical program on track to imminently report topline results from Phase 1/2 study
– Company expects to commence enrollment in pivotal Phase 3 study of Trappsol® Cyclo™ for NPC in Q2 2021
– IND filing for Trappsol® Cyclo™ Alzheimer’s Disease program on track for H2 2021
– Strengthened balance sheet with exercise of warrants
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 suffering from diseases, today reported its financial results for the fourth quarter and full year 2020, and provided a business update.
“I am incredibly pleased with the progress we as a company have made over the past year. On the clinical development front, we completed our Phase 1 study and reported positive interim data from its extension study. We also saw positive interim results from our Phase 1/2 study in NPC and expect to report topline results from the study imminently. Additionally, our team has been working diligently with regulators, patient advocacy groups and clinicians to design our upcoming, pivotal Phase 3 study which is expected to commence next quarter,” commented N. Scott Fine, CEO of Cyclo Therapeutics.
“On the corporate side, we have been working to bolster our leadership team and made multiple key hires including a Chief Commercial Officer and Chief Medical Officer, both of whom bring tremendous value as we begin to plan for success and the potential approval of Trappsol® Cyclo™ for the treatment of NPC,” continued Mr. Fine. “Our team is extremely excited for 2021 and, we believe, is poised to achieve a number of value-driving milestones.”
Trappsol® Cyclo™ Clinical Program Update
Trappsol® Cyclo™ is a proprietary formulation of hydroxypropyl beta cyclodextrin, used intravenously (IV) and currently in development for the treatment of NPC, a rare genetic disorder causing cholesterol accumulation in lysosomes of cells, organ dysfunction and premature death. The Company is also planning a clinical study to evaluate Trappsol® Cyclo™ for the treatment of Alzheimer’s Disease, targeting the reduction of amyloid beta and tau.
Expected Upcoming Milestones
- Report topline results from Phase 1/2 study evaluating Trappsol® Cyclo™ for the treatment of NPC in March 2021;
- Enroll and dose the first patient in pivotal Phase 3 study for NPC in Q2 2021;
- NPC pivotal Phase 3 study interim analysis topline results expected in Q4 2022;
- Commence commercial-scale batch runs for NPC in Q3 2021; and
- Filing IND in H2 2021 for potential Phase 2 study evaluating Trappsol® Cyclo™ for the treatment of Alzheimer’s Disease.
Summary of Financial Results for Fiscal Year 2020
Net loss for the year ended December 31, 2020 was approximately $8.9 million. Research and development expenses increased 25% to $6.0 million for 2020, from $4,869,000 for 2019. The increase in research and development expenses is due to increased activity in our International Clinical Program and U.S. clinical trials. We expect research and development costs to further increase in 2021 as we continue to seek regulatory approval for the use of Trappsol® Cyclo™ in the treatment of NPC and Alzheimer’s disease. In December 2020, the Company closed a public offering including the exercise of the underwriter’s over-allotment option resulting in total gross proceeds of $14.4 million. Subsequent to the closing of the public offering through March 12, 2021, warrants to purchase an aggregate of 1,654,184 shares of Common Stock were exercised resulting in gross proceeds to the Company of $8.3 million. The Company ended the year with approximately $12.9 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 suffering from disease. The Company’s Trappsol® Cyclo™, an orphan drug designated product in the United States and Europe, is the subject of three ongoing formal clinical trials for Niemann-Pick Disease Type C, a rare and fatal genetic disease, (ClinicalTrials.gov NCT02939547, NCT02912793 and NCT03893071). The company is planning an early phase clinical trial using Trappsol® Cyclo™ intravenously in Alzheimer’s Disease based on encouraging data from an Expanded Access program for late-onset 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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