NASDAQ: CYTH cyclotherapeutics.com
November 2021
Corporate Presentation
Forward-Looking Statements
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Some of the information in this presentation relates to future events or future business and financial performance. Such statements constitute forward-looking information within the meaning of the Private Securities Litigation Act of 1995. Such statements can be only predictions and the actual events or results may differ from those discussed due to, among other things, the risks described in the public filings and other publications of Cyclo Therapeutics, Inc. Forward-looking statements are identified by words such as "anticipates", "projects", "expects", "plans", "intends", "believes", "estimates", "target", and other similar expressions that indicate trends and future events.
The market data and certain other statistical information used throughout this presentation are based on independent industry publications, governmental publications, reports by market research firms or other independent sources. Some data are also based on the Company's good faith estimates. In addition, this presentation includes summaries of scientific activities and outcomes that have been condensed to aid the reader in gaining general understanding.
The information about Cyclo Therapeutics, Inc. and its subsidiaries is solely for information purposes and is not to be construed as an offer to sell or the solicitation of an offer to buy any security in any state.
Factors that could cause the Company's results to differ materially from those expressed in forward looking statements include, without limitation, the Company's need for additional capital; the Company's reliance on its Trappsol® Cyclo™ product, which may never receive regulatory approval; the Company's ability to commercialize any of its proposed drug products if it receives regulatory approval; the outcome of the Company's clinical trials, which may not support the Company's product claims or may result in adverse side effects; the cost and timing of the Company's clinical trials; the Company's reliance on third parties to conduct clinical trials and to produce its products; and other risks associated with being a clinical stage biotechnology company.
This presentation is not to be copied, transmitted, displayed, distributed (for compensation or otherwise), or altered in any way without the prior written consent of Cyclo Therapeutics, Inc.
NASDAQ: CYTH cyclotherapeutics.com
Investment Opportunity
Deep expertise with Cyclodextrins with over 10 years of patient exposure
Lead program, Trappsol® Cyclo™ demonstrated to be safe and effective in multiple clinical studies in NPC
Potential to be first targeted therapy for patients with neurodegenerative diseases
Leadership team with proven expertise
Manufacturing at commercial scale inclusive of 60-month stability and 96hr In-use stability
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Currently Targeting 2 Serious Diseases with Unmet Medical Need
Niemann Pick Disease Type C
Fatal and progressive genetic disorder Orphan indication affecting >9,000 in 80 countries (~400 in U.S. / 320 EU5) 1
Alzheimer's Disease
6th leading cause of death affecting
5 million people in the U.S.2
Platform technology has potential to fuel pipeline expansion opportunities
1. April 2021, Tessellon Inc. (former Kantar Health experts with 25+ years of epidemiology and forecasting experience),
NASDAQ: CYTH(www.Tessellon.com); Exhaustive literature search with a broad range of MESH terms in United States + 79 other countries.
cyclotherapeutics.com 2. https://www.alz.org/alzheimers-dementia/facts-figures
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Target Upcoming Milestones with Potential to Drive Value
Pivotal | Manufacturing | |||
Phase 1/2 study | Phase 3 study | |||
Niemann-Pick | ✓ | ✓ | ✓ | |
Disease Type C | ||||
Positive topline results | Site activation ongoing and | Commercial scale-up | ||
reported March 2021 | currently enrolling patients | batch runs: Q3 2021 | ||
Alzheimer's | Pre-IND meeting | File IND for potential Phase 2 study | ||
Disease | ✓ | |||
Q2 2021 | Q4 2021 | |||
Niemann-Pick Disease Type C Regulatory Highlights
Orphan Drug Designation in U.S. | Fast Track Status in U.S.| Potential for Priority Review Voucher (PRV) in U.S
Rare Pediatric Disease Designation | Orphan Designation in EU | | EMA Pediatric Investigational Plan Adopted | |
NASDAQ: CYTH | 1: As of June 30, 2021; 2: As of September 30, 2021; 3: As of August 13, 2021 | |
cyclotherapeutics.com | ||
Leadership Team with Proven Experience
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N. Scott Fine | Joshua M. Fine |
Chief Executive Officer & Director | Chief Financial Officer |
Lise Lund Kjems, MD, PhD | Michael Lisjak |
Chief Medical Officer | Chief Regulatory Officer |
Sharon H. Hrynkow, Ph.D. | Russ Belden |
Chief Scientific Officer | Acting Chief Commercial Officer |
Jeffrey L. Tate, Ph.D. | Lori McKenna Gorski |
Chief Operating Officer, Chief Quality Officer & Director | Global Head of Patient Advocacy |
NASDAQ: CYTH cyclotherapeutics.com
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Cyclo Therapeutics Inc. published this content on 08 November 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 November 2021 20:27:05 UTC.