Cyclo Therapeutics Provides Business Update and Reports First Quarter 2023 Financial Results
15 Maggio 2023 - 2:05PM
Business Wire
- Company on track to complete enrollment in ongoing pivotal
Phase 3 global study (TransportNPC™) evaluating Trappsol® Cyclo™
for Niemann-Pick Disease Type C1 (NPC1) by year end 2023
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 first quarter of 2023 and provided a
business update.
“We continued to execute both clinically and operationally last
quarter. We remain on track to be fully enrolled in our Transport
NPC study by the end of the year and can’t thank the NPC community
enough for their continued support in working with us in advancing
the study of Trappsol® Cyclo™ as a potential treatment to all
living with NPC. In addition, we received continued support
financially from our board of directors and welcomed strategic
investor Rafael Holdings in two successful fund raises completed
following the end of the quarter. Our commitment to the NPC
community remains steadfast and strong; we are here with you,”
commented N. Scott Fine, CEO of Cyclo Therapeutics.
Recent Highlights
- TransportNPC™ pivotal study on track to be 50% enrolled by the
end of May 2023; Company on track to complete enrollment by year
end;
- Completed financings with gross proceeds totaling $7.7 million,
with participation by the Company’s Board and Management, and a
strategic investment by Rafael Holdings, Inc. (NYSE: RFL);
- Appointed global pharmaceutical and biotechnology
commercialization leader, William Conkling, Rafael’s Chief
Executive Officer, to the Board of Directors of Cyclo Therapeutics;
and
- Commenced Phase 2b study of Trappsol® Cyclo™ for the treatment
of early Alzheimer’s Disease.
Summary of Financial Results for the First Quarter
2023
Net loss for the quarter ended March 31, 2023 was approximately
$5.0 million. Research and development expenses increased 213% to
$3.4 million for the quarter ended March 31, 2023, from $1.1
million for the quarter ended March 31, 2022. The changes in
research and development expenses relate to the increased activity
in the Company’s Phase 3 study of Trappsol® Cyclo™ for the
treatment of NPC. The Company expects research and development
costs to increase in 2023 as Cyclo Therapeutics continues to seek
regulatory approval for the use of Trappsol® Cyclo™ in the
treatment of NPC and Alzheimer’s disease.
The Company ended the quarter on a pro forma basis with
approximately $3.0 million of cash, after giving effect to the
recent financings.
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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JTC Team, LLC Jenene Thomas (833) 475-8247 CYTH@jtcir.com
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