Cyclo Therapeutics Reports Third Quarter 2022 Financial Results and Highlights Recent Achievements
12 November 2022 - 12:05AM
Business Wire
– 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)
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20221111005107/en/
Investor Contact: JTC Team, LLC Jenene Thomas (833)
475-8247 CYTH@jtcir.com
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