Cyclo Therapeutics Reports Second Quarter 2023 Financial Results
2023年8月15日 - 9:05PM
ビジネスワイヤ(英語)
Continued strong enrollment of pivotal Phase 3
global study (TransportNPC™) evaluating Trappsol® Cyclo™ for
Niemann-Pick Disease Type C1 (NPC1) on track to complete enrollment
by year end 2023
Company anticipates achieving 60% of enrollment
of TransportNPC™ by end of August
Topline results from TransportNPC™ expected Q4
2024
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 second quarter 2023.
“Over the past quarter, we continued to execute on all fronts.
We remain focused on driving recruitment in our pivotal
TransportNPC™ study of Trappsol® Cyclo™ and are on track to
complete enrollment by the end of this year. Our commitment to the
NPC community remains steadfast, strong and a top priority. We are
working diligently to bring a safe and effective treatment option
where there remains a significant unmet need,” commented N. Scott
Fine, Chief Executive Officer of Cyclo Therapeutics.
Recent Highlights
- Extended cash runway with the closing of a $5.0 million private
placement with strategic investor, Rafael Holdings, Inc. (NYSE:
RFL);
- Continued prioritization on patient engagement and advocacy
through participation at the 2023 NNPDF Family Support &
Medical Conference and China NPC meeting to connect with the global
NPC community and discuss Trappsol® Cyclo™ and its clinical
development program for the treatment of NPC;
- Announced the publication of positive, confirmatory data from
its Phase 1/2 clinical trial, which demonstrated promising safety
and efficacy results for Trappsol® Cyclo™ in the treatment of
Niemann-Pick Disease Type C1; and
- Received allowance of patent from European Patent Office for
Trappsol® Cyclo™ for Alzheimer’s Disease.
Summary of Financial Results for the Second Quarter
2023
Net loss for the quarter ended June 30, 2023 was approximately
$4.6 million. Research and development expenses increased 69% to
approximately $3.2 million for the three months ended June 30,
2023, from approximately $1.9 for the three months ended June 30,
2022. The increase in research and development expense resulted
from the increased activity in our Phase 3 study of Trappsol®
Cyclo™ for the treatment of NPC in the more recent period. We
expect research and development costs to increase in 2023 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 $0.8 million of
cash. Subsequent to quarter-end, the Company generated gross
proceeds of $5.0 million from the sale of securities in private
placements of the Company’s securities.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230815452049/en/
Investor Contact: JTC Team, LLC Jenene Thomas (833)
475-8247 CYTH@jtcir.com
Rafael (NYSE:RFL)
過去 株価チャート
から 8 2024 まで 9 2024
Rafael (NYSE:RFL)
過去 株価チャート
から 9 2023 まで 9 2024