Cyclo Therapeutics’ TransportNPC™ Phase 3
clinical trial for Trappsol® Cyclo™ for the treatment of
Niemann-Pick Disease Type C1, a rare and fatal genetic disease, is
fully enrolled and results from the 48-week interim analysis are
expected in the middle of 2025
Rafael Holdings, Inc. (NYSE: RFL), and Cyclo Therapeutics, Inc.
(Nasdaq: CYTH) today announced that they have entered into a
definitive merger agreement to combine the two companies to focus
on the development of Trappsol® Cyclo™ for the treatment of
Niemann-Pick Disease Type C1. On consummation of the merger, Rafael
Holdings will issue shares of its Class B common stock to Cyclo
Therapeutics’ shareholders, based on an exchange ratio valuing
Cyclo Therapeutics shares at $.95 per share and Rafael Holdings at
its cash value combined with the value of its marketable securities
and certain other investments less certain current liabilities. In
addition, the cash value will take into account the funding of
Cyclo’s operations by Rafael with convertible notes through
closing. Following the closing, Rafael Holdings intends to fund the
TransportNPC™ clinical trial to its 48-week interim analysis. The
boards of directors of Rafael Holdings and Cyclo Therapeutics have
approved this transaction and expect it to close in late 2024,
pending approval of the companies’ shareholders, the effectiveness
of a registration statement to register the shares of Class B
common stock of Rafael Holdings to be issued in the transaction and
other customary closing conditions.
Rafael Holdings made its first strategic investment in Cyclo
Therapeutics in March 2023 to help drive treatment innovation for
patients with the debilitating diagnosis of Niemann-Pick Disease
Type C1. Rafael Holdings led another financing round in the fall of
2023 and has continued to support Cyclo Therapeutics via
convertible debt financings in 2024.
“The proposed merger with Cyclo Therapeutics is a major step
forward in our strategy to invest in, develop and commercialize
clinical stage assets in areas of high unmet medical need,” said
Bill Conkling, President and CEO of Rafael Holdings. Bill added,
“Cyclo Therapeutics continues to make substantial progress in
advancing its lead asset, Trappsol® Cyclo™, announcing the
completion of enrollment in its pivotal TransportNPC™ Phase 3
clinical study for the treatment of Niemann-Pick Disease Type C1 at
the end of May 2024. We are impressed with the execution by the
Cyclo Therapeutics team in fully enrolling a comprehensive clinical
trial in NPC and we eagerly await the 48-week interim analysis in
the middle of 2025. Rafael Holdings is excited to join forces with
Cyclo Therapeutics to make Trappsol® Cyclo™ our lead clinical
program. We are committed to the program and will leverage our
resources to help bring this much needed treatment option to NPC
patients.”
N. Scott Fine, Chief Executive Officer of Cyclo Therapeutics,
commented, “Our partnership with Rafael Holdings during the last
year and a half has enabled Cyclo to get to where we are today. We
are extremely pleased to announce our merger agreement with Rafael
Holdings and believe that the strength of Rafael’s balance sheet
and its strong management team will solidify our commitment to
deliver the results of the TransportNPC™ trial for our shareholders
and patients.”
Cassel Salpeter & Co. is acting as financial advisor to
Cyclo Therapeutics in connection with the transaction. Schwell
Wimpfheimer & Associates is serving as legal advisor to Rafael
Holdings and Fox Rothschild LLP is serving as legal advisor to
Cyclo Therapeutics.
About Rafael Holdings, Inc.
Rafael Holdings is a holding company with interests in clinical
and early-stage pharmaceutical companies including an investment
and planned merger with Cyclo Therapeutics, Inc. (Nasdaq: CYTH), a
clinical-stage biotechnology company dedicated to developing
life-changing medicines for patients and families living with
challenging diseases through its lead therapeutic asset, Trappsol®
Cyclo™, a majority investment in Cornerstone Pharmaceuticals, Inc.,
formerly known as Rafael Pharmaceuticals Inc., a cancer
metabolism-based therapeutics company, a majority equity interest
in LipoMedix Pharmaceuticals Ltd., a clinical stage pharmaceutical
company, the Barer Institute Inc., a wholly-owned preclinical
cancer metabolism research operation, a majority investment in Day
Three Labs, Inc., a company which reimagines existing cannabis
offerings with pharmaceutical-grade technology and innovation like
Unlokt™ to bring to market better, cleaner, more precise and
predictable products in the cannabis industry, and a majority
interest in Rafael Medical Devices, LLC, an orthopedic-focused
medical device company developing instruments to advance minimally
invasive surgeries. Rafael’s primary goal has been to expand its
investment portfolio through opportunistic and strategic
investments including therapeutics which address high unmet medical
needs. Upon closing of the merger transaction with Cyclo
Therapeutics, Rafael intends to focus its efforts on making
Trappsol® Cyclo™ its lead clinical program.
About Cyclo Therapeutics, Inc.
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.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do not
relate to matters of historical fact should be considered
forward-looking statements, including without limitation statements
regarding our expectations surrounding the potential, safety,
efficacy, and regulatory and clinical progress of our product
candidates; plans regarding the further evaluation of clinical data
in the success of the potential combination with Cyclo
Therapeutics; and the potential of our pipeline. These statements
are neither promises nor guarantees, but involve known and unknown
risks, uncertainties and other important factors that may cause our
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements Among other
things, these risks include that there can be no guarantee that the
proposed business combination will be completed in the anticipated
timeframe or that the conditions required to complete the proposed
combination will be met. In addition, these risks include, but are
not limited to, those disclosed under the caption “Risk Factors” in
Rafael’s Annual Report on Form 10-K for the year ended July 31,
2023, and Cyclo’s Annual Report on Form 10-K for the year ended
December 31, 2023 and the companies’ other filings with the SEC.
All these factors could cause actual results to differ materially
from those indicated by the forward-looking statements made in this
press release. Any such forward-looking statements represent the
companies’ management’s estimates as of the date of this press
release. While they may elect to update such forward-looking
statements at some point in the future, the companies disclaim any
obligation to do so, even if subsequent events cause views to
change.
No Offer or Solicitation
This press release is not a proxy statement or solicitation of a
proxy, consent or authorization with respect to any securities or
in respect of the proposed business combination and shall not
constitute an offer to sell or a solicitation of an offer to buy
any securities, nor shall there be any sale of securities in any
state or jurisdiction in which such offer, solicitation, or sale
would be unlawful prior to registration or qualification under the
securities laws of any such state or jurisdiction. No offer of
securities shall be made except by means of a prospectus meeting
the requirements of the Securities Act.
Important Additional Information Will Be Filed with the
SEC
Rafael Holdings plans to file with the SEC a Registration
Statement on Form S-4 in connection with the transactions and both
Rafael Holdings and Cyclo Therapeutics plan to file with the SEC
and mail to their respective stockholders a Joint Proxy
Statement/Prospectus in connection with the transactions. Investors
and security holders are urged to read the Registration Statement
and the Joint Proxy Statement/Prospectus and other relevant
documents filed with the SEC in connection with the proposed
transaction or incorporated by reference into the Joint Proxy
Statement/Prospectus (if any) carefully when they are available
before making any voting or investment decision with respect to the
proposed transactions. The Registration Statement, the Joint Proxy
Statement/Prospectus and other documents filed with the SEC in
connection with the proposed transaction or incorporated by
reference into the Joint Proxy Statement/Prospectus (if any) will
contain important information about Rafael Holdings, Cyclo
Therapeutics, the transactions and related matters. Investors and
security holders will be able to obtain free copies of the
Registration Statement and the Joint Proxy Statement/Prospectus and
other documents filed with the SEC by Rafael Holdings and Cyclo
Therapeutics through the web site maintained by the SEC at
www.sec.gov. In addition, investors and security holders will be
able to obtain free copies of the Registration Statement and the
Joint Proxy Statement/Prospectus from Rafael Holdings by contacting
david.polinsky@rafaelholdings.com or Cyclo Therapeutics by
contacting cyth@jtcir.com.
Participants in the Solicitation
Rafael and Cyclo and their respective directors and executive
officers may be deemed to be participants in the solicitation of
proxies in respect of the transactions contemplated by the merger
agreement. Information regarding Rafael’s directors and executive
officers is contained in Rafael proxy statement dated November 20,
2023, which is filed with the SEC. Information regarding Cyclo’s
directors and executive officers is contained in Cyclo’s Annual
Report on Form 10-K for the year ended December 31, 2023, which is
filed with the SEC. Additional information regarding the persons
who may be deemed participants in the proxy solicitation and a
description of their direct and indirect interests in the proposed
business combination will be available in the Registration
Statement and the Joint Proxy Statement/Prospectus.
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version on businesswire.com: https://www.businesswire.com/news/home/20240822425306/en/
Rafael Holdings Investor Relations Barbara Ryan
Barbara.ryan@rafaelholdings.com (203) 274-2825
Cyclo Therapeutics Investor Relations JTC Team, LLC Jenene
Thomas (833) 475-8247 CYTH@jtcir.com
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