Cyclo Therapeutics Reports Third Quarter 2023 Financial Results
15 Novembre 2023 - 2:05PM
Business Wire
Strong pace of enrollment continues in pivotal
Phase 3 global study (TransportNPC™) evaluating Trappsol® Cyclo™
for Niemann-Pick Disease Type C1 (“NPC1”)
Merger with Applied Molecular Transport, Inc.
(“AMT”) on track to close before year end
Company continues to bolster cash position to
extend runway through clinical and regulatory milestones
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 2023.
“Our number one priority remains to be the solid operational
execution of our TransportNPC™ study. We are very pleased with our
continued strong pace of enrollment and importantly the strong
level of engagement with the NPC community. We remain hopeful that
we will bring enrollment for this important study to a close in the
coming months,” commented N. Scott Fine, Chief Executive Officer of
Cyclo Therapeutics. “Further, during the quarter we entered into a
strategic merger agreement with Applied Molecular Transport, which
we expect to close before year end. Finally, we have taken
important steps over the past quarter and in the recent weeks to
strengthen our balance sheet and provide the necessary cash to
bring us through key milestones for the Company.”
Recent Highlights
- Entered into a definitive agreement with Applied Molecular
Transport Inc. (Nasdaq: AMTI), to focus on advancing Cyclo
Therapeutics’ pivotal Phase 3 global study. TransportNPC™,
evaluating Trappsol® Cyclo™ for NPC. The transaction is currently
expected to close in the fourth quarter of 2023;
- Continued NPC community engagement through attendance at INPDA
Face-to-Face Meeting, Critical Path Institute Scientific
Breakthrough Summit, and the SSIEM Annual Symposium 2023;
- Closed of $5.0 million Private Placement with Rafael Holdings,
Inc.; and
- Further strengthened Balance Sheet with early exercise of
warrants by board members, management and a significant shareholder
resulting in bolstered cash proceeds of $2.4 million.
About the Proposed Transaction
As previously announced, AMT and Cyclo Therapeutics entered into
a definitive agreement (the Merger Agreement) pursuant to which AMT
will merge with Cyclo Therapeutics in an all-stock transaction (the
“Merger”). Following the closing of the Merger, the combined
company will operate under the name “Cyclo Therapeutics, Inc.” and
will continue trading on The Nasdaq Capital Market under the ticker
symbol “CYTH”. The combined company will focus on advancing Cyclo
Therapeutics’ pivotal Phase 3 global study (TransportNPC™)
evaluating Trappsol® Cyclo™ for NPC.
Under the terms of the Merger Agreement, AMT stockholders will
receive approximately 0.174 shares of Cyclo Therapeutics in
exchange for each of their shares in AMT (subject to adjustment
based on AMT’s net cash at closing). Cyclo Therapeutics expects to
issue approximately 7.624 million shares of Cyclo Therapeutics’
common stock to AMT shareholders, equating to approximately 25% of
the combined company on a fully diluted basis.
The combined company will be led by the existing Cyclo
Therapeutics management team and will be headquartered in
Gainesville, FL. Subsequent to the closing of the transaction,
Shawn Cross, Chief Executive Officer and Board Chair of AMT will be
appointed to the Cyclo Therapeutics Board of Directors.
The Merger has been approved by the board of directors of each
company and is currently expected to close in the fourth quarter of
2023, subject to the satisfaction or waiver of customary
conditions, including the requisite approval by Cyclo Therapeutics’
and AMT’s stockholders and the effectiveness of a registration
statement on Form S-4 to register the shares of Cyclo Therapeutics
common stock to be issued in connection with the transaction. As
the transaction proceeds, the parties will publicly disclose
required information either through press releases or filings with
the Securities and Exchange Commission (the “SEC”), as
appropriate.
MTS Health Partners, L.P. is acting as financial advisor to AMT
in connection with the transaction. Fox Rothschild LLP is serving
as legal advisor to Cyclo Therapeutics and Wilson Sonsini Goodrich
& Rosati, P.C. is serving as legal advisor to AMT.
Summary of Financial Results for the Third Quarter
2023
Net loss for the quarter ended September 30, 2023 was
approximately $4.7 million. Research and development expenses
increased 21% to approximately $3.5 million for the three months
ended September 30, 2023, from approximately $2.9 for the three
months ended September 30, 2022. The increase in research and
development expense resulted from the increased activity in the
Company’s Phase 3 study of Trappsol® Cyclo™ for the treatment of
NPC in the more recent period. The Company expects 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 $1.8 million of
cash. Subsequent to quarter-end, the Company generated cash
proceeds of $2.4 million from the early exercise of warrants from
certain accredited investors.
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/20231115252117/en/
Investor Contact: JTC Team, LLC Jenene Thomas (833)
475-8247 CYTH@jtcir.com
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