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 announced that two abstracts have been accepted for poster presentation at the SSIEM Annual Symposium 2024 being held September 3-6, 2024 in Porto, Portugal.

“We truly value the opportunity and are honored to present our data at this preeminent scientific congress to further strengthen our voice within the NPC community. Our TransportNPC™ study is the most comprehensive ongoing controlled pivotal study regarding patient size, global footprint, duration and clinical outcomes for the treatment of Niemann-Pick Disease Type C1. We are extremely proud of the progress with our fully enrolled, ongoing TransportNPC™. Our team has strong belief in our program, and we look forward to further engaging with the community at this important meeting and discussing our potential to have a meaningful impact for people living with NPC globally,” commented N. Scott Fine, Chief Executive Officer of Cyclo Therapeutics.

Details of the poster presentations are as follows:

Title: TRANSPORTNPC™: Phase 3 global trial of intravenous hydroxypropyl-beta-cyclodextrin (HPβCD) in patients three years of age or older with Niemann-Pick disease type C1 (NPC1)

Presenter: Caroline Hastings, Beata Kieć-Wilk, Lukasz Pawlinski, Faith Ezgu, Roberto Giugliani, Eugen Mengel, Elena Martin-Hernandez, Reena Sharma, Nicholas Smith, Nancy Chien, Sema Kalkan Ucar, Mark Walterfang, Victor Fung, Ozlem Goker-Alpan, Norberto Guelbert, Thorsten Marquardt, Leonardo Mendonça, Anna Ardissone, Alberto Burlina, Jordi Gascón, Loren Pena, Heidi Peters, Julian Raiman, Ronen Spiegel, Orna Staretz Chacham, Moeen AlSayed, Robin Lachmann, Dariusz Rokicki, Bryan Hurst, Bryan Murray, Andreas Brecht, and Joseph Mejia

Key Discussion points for this poster will be:

  1. Safety data
  2. Descriptive patient cohort data
  3. Neurological outcomes and the use of novel assessment technology

Title: TRANSPORTNPC™: Phase 3 global trial of intravenous hydroxypropyl-beta-cyclodextrin (HPβCD) in patients with Niemann-Pick disease type C1 (NPC1) – open label sub-study in patients below 3 years of age

Presenter: Orna Staretz Chacham, Fatih Ezgu, Roberto Giugliani, Eugen Mengel, Sema Kalkan Ucar, Ronen Spiegel, Moeen AlSayed, Caroline Hastings, Bryan Hurst, Bryan Murray, Andreas Brecht, and Joseph Mejia

Key Discussion points for this poster will be:

  1. Safety data
  2. Clinical endpoint discussion
  3. The concept of early intervention and prevention of disease progression

For more information about SSIEM 2024, please visit ssiem2024.org.

About SSIEM

The aim of the Society is to foster the study of inherited metabolic disorders and related topics. The Society exists to promote exchange of ideas between professional workers in different disciplines who are interested in inborn errors of metabolism (IEM). This is achieved through the organization of the annual symposium and associated scientific meetings, publications and provision of funding for educational and training support. The SSIEM Council (Council) is also supplemented by an Advisory Council who provide advice and meet with the Council at the annual symposium.

The Society, a registered charity and limited company, accepts donations from sponsors sympathetic to its aims. The Council, within its financial resources, is willing to spread interest and study in inborn errors around the world by selectively supporting membership and attendance at conferences from areas of the world where financial resources are more limited. The Society does not directly fund research, but offers on request, advice to other organizations that do so. Education and training in IEM are also an important aim of the SSIEM.

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 C1, 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.

Investor Contact: JTC Team, LLC Jenene Thomas (833) 475-8247 CYTH@jtcir.com

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