Combined company operating as Cyclo
Therapeutics with primary focus on advancing Trappsol® Cyclo™ for
the treatment of Niemann-Pick Disease Type C1 (NPC1)
Cash runway extended into 2H 2024 with
approximately $11.0 million cash on hand to fund operations
Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or
the “Company”), a clinical stage biotechnology company focused on
developing transformative therapies for rare and neurological
diseases with limited treatment options, and Applied Molecular
Transport Inc. (Nasdaq: AMTI) (“AMT”), a biopharmaceutical company,
announced today the closing of its previously announced transaction
pursuant to which AMT will merge with Cyclo Therapeutics in an
all-stock transaction.
The combined company will now operate under the name “Cyclo
Therapeutics, Inc.” and will continue trading on The Nasdaq Capital
Market under the ticker symbol “CYTH”. Cyclo Therapeutics’ primary
focus will continue to be on advancing its pivotal Phase 3 global
study (TransportNPC™) evaluating Trappsol® Cyclo™ for Niemann-Pick
Disease Type C1 (NPC1).
“The completion of this merger with Applied Molecular Transport
represents a significant milestone and bolsters our confidence and
excitement for the future of Cyclo Therapeutics. With the merger
now closed and following our recent positive Type C meeting with
the FDA, fundamentally the Company has never been stronger,”
commented N. Scott Fine, CEO of Cyclo Therapeutics. “Moving
forward, we are focused on completing our Phase 3 study and
executing on the regulatory submission process, assuming a
successful outcome in our pivotal study. We remain dedicated to
providing a much-needed treatment option for NPC patients.”
About the Transaction
As previously announced, under the terms of the merger
agreement, AMT stockholders will receive 0.1331 shares of Cyclo
Therapeutics in exchange for each of their shares in AMT. Cyclo
Therapeutics expects to issue approximately 5,822,720 shares of
Cyclo Therapeutics’ common stock to AMT shareholders, equating to
approximately 18.0 % 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 has
been appointed to the Cyclo Therapeutics Board of Directors.
MTS Health Partners, L.P. acted as financial advisor to AMT in
connection with the transaction. Fox Rothschild LLP served as legal
advisor to Cyclo Therapeutics and Wilson Sonsini Goodrich &
Rosati, P.C. served as legal advisor to AMT.
About Cyclo Therapeutics
Cyclo Therapeutics, Inc. is a clinical stage biotechnology
company focused on developing transformative therapies for rare and
neurological diseases with limited treatment options. 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.
Forward-Looking Statements
This press release contains forward-looking statements for the
purposes of the safe harbor provisions under The Private Securities
Litigation Reform Act of 1995 and other federal securities laws.
These statements are often identified by the use of words such as
“anticipate,” “believe,” “can,” “continue,” “could,” “estimate,”
“expect,” “intend,” “likely,” “may,” “might,” “objective,”
“ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “to
be,” “will,” “would,” “target,” potential,” “probable,”
“opportunity,” “future,” “promising,” “likely” or the negative or
plural of these words, or similar expressions or variations,
although not all forward-looking statements contain these words. We
cannot assure you that the events and circumstances reflected in
the forward-looking statements will be achieved or occur and actual
results could differ materially from those expressed or implied by
these forward-looking statements. Factors that could cause or
contribute to such differences include, but are not limited to,
those identified herein, and those discussed in the section titled
“Risk Factors” set forth in Cyclo Therapeutics’ Annual Report on
Form 10-K for the year ended December 31, 2022, AMT’s Annual Report
on Form 10-K for the year ended December 31, 2022, AMT’s Quarterly
Report on Form 10-Q for the quarter ended March 31, 2023, and AMT’s
Quarterly Report on Form 10-Q for the quarter ended June 30, 2023,
each of which is on file with the Securities and Exchange
Commission (“SEC”). Among other things, there can be no guarantee
that the combined company will realize the expected benefits of the
business combination, if any, that the combined company will have
success in achieving regulatory approval for its clinical
protocols, enrollment of adequate number of patients in its
clinical trials, unforeseen difficulties in showing efficacy of
Trappsol® Cyclo™, success in attracting additional customers and
profitable contracts, and regulatory risks associated with
producing pharmaceutical grade products.
These risks are not exhaustive. New risk factors emerge from
time to time, and it is not possible for our respective management
teams to predict all risk factors, nor can we assess the impact of
all factors on our respective businesses or the extent to which any
factor, or combination of factors, may cause actual results to
differ materially from those contained in any forward-looking
statements. In addition, statements that “we believe” and similar
statements reflect our beliefs and opinions on the relevant
subject. These statements are based upon information available to
us as of the date hereof and while we believe such information
forms a reasonable basis for such statements, such information may
be limited or incomplete, and our statements should not be read to
indicate that we have conducted an exhaustive inquiry into, or
review of, all potentially available relevant information. These
statements are inherently uncertain, and investors are cautioned
not to unduly rely upon these statements. Except as required by
law, we undertake no obligation to update any forward-looking
statements to reflect events or circumstances.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231227151063/en/
Investor Contact: JTC Team, LLC Jenene Thomas (833)
475-8247 CYTH@jtcir.com
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