Cyclo Therapeutics Presents Enterprise Update and Reports Fourth Quarter and Whole Calendar year 2020 Economical Success

– Many worth-driving milestones expected through 2021

– Trappsol^® Cyclo™ Niemann Choose Disorder Style C (NPC) scientific method on track to imminently report topline effects from Section 1/2 examine

– Enterprise expects to begin enrollment in pivotal Section 3 review of Trappsol^® Cyclo™ for NPC in Q2 2021

– IND submitting for Trappsol^® Cyclo™ Alzheimer’s Sickness plan on keep track of for H2 2021

– Strengthened harmony sheet with physical exercise of warrants

Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Organization”), a clinical phase biotechnology firm committed to establishing daily life-transforming medications by way of science and innovation for people and families struggling from disorders, right now noted its fiscal final results for the fourth quarter and full yr 2020, and furnished a small business update.

“I am extremely pleased with the development we as a company have created in excess of the past yr. On the clinical improvement front, we completed our Section 1 review and described beneficial interim information from its extension analyze. We also observed constructive interim outcomes from our Stage 1/2 examine in NPC and be expecting to report topline success from the analyze imminently. In addition, our group has been working diligently with regulators, individual advocacy groups and clinicians to design and style our approaching, pivotal Period 3 study which is expected to commence subsequent quarter,” commented N. Scott Great, CEO of Cyclo Therapeutics.

“On the company facet, we have been operating to bolster our management group and created a number of vital hires such as a Chief Industrial Officer and Chief Health-related Officer, both of those of whom deliver large worth as we get started to approach for accomplishment and the potential approval of Trappsol^® Cyclo™ for the therapy of NPC,” continued Mr. High-quality. “Our team is exceptionally fired up for 2021 and, we feel, is poised to reach a range of value-driving milestones.”

Trappsol^® Cyclo™ Scientific Application Update

Trappsol^® Cyclo™ is a proprietary formulation of hydroxypropyl beta cyclodextrin, utilized intravenously (IV) and currently in advancement for the cure of NPC, a rare genetic condition resulting in cholesterol accumulation in lysosomes of cells, organ dysfunction and untimely loss of life. The Corporation is also setting up a medical examine to assess Trappsol^® Cyclo™ for the therapy of Alzheimer’s Ailment, targeting the reduction of amyloid beta and tau.

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Anticipated Upcoming Milestones

• Report topline benefits from Period 1/2 research analyzing Trappsol^® Cyclo™ for the remedy of NPC in March 2021

• Enroll and dose the initial affected person in pivotal Period 3 analyze for NPC in Q2 2021

• NPC pivotal Period 3 research interim evaluation topline results envisioned in Q4 2022

• Begin commercial-scale batch operates for NPC in Q3 2021 and

• Filing IND in H2 2021 for opportunity Phase 2 examine evaluating Trappsol^® Cyclo™ for the treatment of Alzheimer’s Sickness.

Summary of Economic Effects for Fiscal 12 months 2020

Internet loss for the year finished December 31, 2020 was around $8.9 million. Exploration and enhancement costs greater 25% to $6. million for 2020, from $4,869,000 for 2019. The raise in exploration and advancement bills is due to increased exercise in our Global Medical Software and U.S. clinical trials. We expect investigate and development prices to even further raise in 2021 as we keep on to search for regulatory acceptance for the use of Trappsol^® Cyclo™ in the treatment method of NPC and Alzheimer’s ailment. In December 2020, the Company shut a general public supplying together with the exercise of the underwriter’s around-allotment alternative ensuing in total gross proceeds of $14.4 million. Subsequent to the closing of the community presenting by way of March 12, 2021, warrants to purchase an combination of 1,654,184 shares of Typical Inventory were exercised resulting in gross proceeds to the Company of $8.3 million. The Organization ended the 12 months with close to $12.9 million of income.

About Cyclo Therapeutics

Cyclo Therapeutics, Inc. is a medical-stage biotechnology firm focused to creating existence-shifting medicines by way of science and innovation for clients and family members suffering from sickness. The Company’s Trappsol^® Cyclo™, an orphan drug selected item in the United States and Europe, is the matter of 3 ongoing official clinical trials for Niemann-Decide Sickness Style C, a exceptional and deadly genetic disorder, (ClinicalTrials.gov NCT02939547, NCT02912793 and NCT03893071). The corporation is arranging an early stage clinical trial using Trappsol^® Cyclo™ intravenously in Alzheimer’s Condition primarily based on encouraging information from an Expanded Access system for late-onset Alzheimer’s Condition (NCT03624842). Further indications for the energetic component in Trappsol^® Cyclo™ are in development. For supplemental info, visit the company’s website: www.cyclotherapeutics.com.

Harmless Harbor Statement

This push launch contains “ahead-seeking statements” about the company’s present-day expectations about long run success, functionality, prospects and chances, which includes, without limitation, statements about the pleasure of closing circumstances relating to the providing and the predicted use of proceeds from the providing. Statements that are not historical points, these kinds of as “anticipates,” “believes” and “expects” or identical expressions, are ahead-seeking statements. These statements are matter to a range of hazards, uncertainties and other variables that could result in precise benefits in potential durations to vary materially from what is expressed in, or implied by, these statements. The variables which may influence the company’s long run general performance include things like the company’s skill to obtain added capital to increase functions as prepared, accomplishment in obtaining regulatory approval for scientific protocols, enrollment of suitable quantities of individuals in scientific trials, unexpected troubles in exhibiting efficacy of the company’s biopharmaceutical goods, achievement in attracting extra customers and worthwhile contracts, and regulatory threats involved with developing pharmaceutical quality and foods merchandise. These and other possibility components are described from time to time in the company’s filings with the Securities and Exchange Commission, including, but not constrained to, the company’s stories on Sorts 10-K and 10-Q. Unless of course necessary by regulation, the corporation assumes no obligation to update or revise any forward-seeking statements as a end result of new facts or future gatherings.

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Contacts

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Jenene Thomas
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