we are
Investment Summary
Leveraging over 3 decades of experience with cyclodextrins to advance clinically de-risked programs towards approval in diseases with unmet medical need.
Platform technology has demonstrated to be safe and effective with over 10 years of patient exposure.
FDA: Orphan Drug Designation (ODD), Fast-Track, Rare Pediatric Disease Designation, potential PRV; EMA: ODD and adopted PIP
Enrolling and dosing patients in Pivotal Phase 3 study in Niemann-Pick Disease Type C.
Significant market opportunity with no approved therapy to treat both systemic and neurological manifestations of NPC.
Pipeline expansion into Alzheimer's Disease (AD), patent filed globally and is currently being prosecuted.
Received Study May Proceed from FDA December 2021, FPI targeted H2 2022.
Cash Balance1 | Market Cap3 | Shares Outstanding2 | Average Volume3 |
$7.5M | ~$21M | 8.4M | ~20K |
1 As of June 30, 2022, 2 As of August 15, 2022, 3 As of August 15, 2022 with a closing price of $2.48
Our Mission
Our Team
We are dedicated to developing life-changing medicines through science and innovation for patients and families living with challenging diseases.
Our lead therapeutic asset, Trappsol® Cyclo™, is a proprietary formulation of hydroxypropyl beta cyclodextrin, and in multiple clinical studies has shown encouraging results to effectively manage the transportation of cholesterol. Taking the place of the defective NPC1 protein, Trappsol® Cyclo™, with its cyclic structure, facilitates the transport of accumulated cholesterol out of cellular lysosomes so that it can be further processed and excreted out of cells.
N. Scott Fine | Joshua M. Fine | Lisa Lund Kjems, MD, PhD |
CFO | CMO | |
CEO | ||
Michael Lisjak | Lori McKenna Gorski | |
Jeffrey L. Tate, PhD | Global Head of Patient | |
CRO, SVP for Business | ||
Advocacy | ||
Director, COO, CQO | Development | |
Platform Technology Pipeline
Trappsol® Cyclo™ allows for a multiple shots on goal model
Program | Indication | Preclinical | Phase 1 | Phase 2 | Phase 3 | Milestones |
Trappsol® Cyclo™ Niemann-Pick Disease Type C
Trappsol® Cyclo™ Alzheimer's Disease
(Pivotal Phase 3 Study)
Site activation ongoing, enrolling and dosing patients.
Open IND, Phase 2 study expected to commence before end of 2022
Orphan Drug Designation in U.S. | Fast Track Status in U.S. | Potential for Priority Review Voucher (PRV) in U.S.
Orphan Drug Designation in EU | EMA Pediatric Investigational Plan Adopted
Therapeutic Focus Areas
Niemann-Pick Disease Type C (NPC)
Rare, fatal and progressive genetic disorder affecting the brain, liver and spleen characterized by a defect in the NPC1 protein
Cholesterol and lipids accumulate in cells of major organs and tissues leading to cell and tissue dysfunction
1/100,000 instances of NPC
0 U.S. approved NPC therapies
1 E.U approved therapy with no systemic effects
Alzheimer's Disease
The most common form of
Dementia
An irreversible, progressive neurologic disorder that slowly degrades memory, thinking and social skills that affects a person's ability to function independently
5 million+ people affected in the U.S.1
6th leading cause of death in the U.S.1
500,000 new cases every year2
13.8 million cases projected by 20501
Similarities: (1) Cognitive decline, (2) Elevated levels of tau, (3) Amyloid plaques
1. https://www.alz.org/alzheimers-dementia/facts-figures | 2. https://www.brightfocus.org/alzheimers/article/alzheimers-disease-facts-figures
cyclotherapeutics.com | NASDAQ: CYTH | Investor Relations: JTC Team, cyth@jtcir.com
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Cyclo Therapeutics Inc. published this content on 17 August 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 17 August 2022 17:13:04 UTC.