Cyclo Therapeutics, Inc. - CYTH STOCK NEWS

Cyclo Therapeutics (Nasdaq: CYTH) presented encouraging preliminary safety data from its ongoing pivotal Phase 3 study (TransportNPC™) and substudy evaluating Trappsol® Cyclo™ for Niemann-Pick Disease Type C1 (NPC1) at the SSIEM Annual Symposium 2024. The TransportNPC™ study, with 104 enrolled patients, is the most comprehensive controlled pivotal study for NPC1. Key highlights include:

1. Topline data from the 48-week interim analysis expected in H1 2025
2. Trappsol® Cyclo™ demonstrated to be well-tolerated with a consistent safety profile
3. 625 Adverse Events reported, 80% Grade 1 (mild)
4. No patients withdrew due to safety concerns
5. Substudy completed enrollment with ten patients under 3 years old

Cyclo Therapeutics (Nasdaq: CYTH) reported its Q2 2024 financial results and provided a business update. Key highlights include:

1. Completed enrollment in the pivotal Phase 3 TransportNPC™ trial for Niemann-Pick Disease Type C1 (NPC1).
2. Topline data from the 48-week interim analysis expected in H1 2025.
3. Targeting NDA and MAA submissions in 2H 2025 if data shows significance.
4. Net loss for Q2 2024 was approximately $6.0 million.
5. R&D expenses increased 10% to $3.5 million.
6. Cash position at quarter-end was approximately $1.1 million.

The company is focused on developing Trappsol® Cyclo™ for NPC1 and early Alzheimer's disease, with potential for a Priority Review Voucher upon NDA submission.

Cyclo Therapeutics (Nasdaq: CYTH) has received a notice from the European Patent Office of a decision to grant European patent application No. 19805439.7 titled, 'Methods for Treating Alzheimer's Disease' under European patent number 3873604B. The patent will take effect on August 21, 2024.

CEO N. Scott Fine emphasized the importance of this milestone for the company's Alzheimer's disease asset and overall patent portfolio. Cyclo Therapeutics is developing Trappsol® Cyclo™, an orphan drug designated product, which is currently the subject of four formal clinical trials for Niemann-Pick Disease Type C and a Phase 2b clinical trial for early Alzheimer's disease.

Cyclo Therapeutics (Nasdaq: CYTH), a clinical-stage biotechnology company, announced two abstracts accepted for poster presentation at the SSIEM Annual Symposium 2024 in Porto, Portugal, scheduled for September 3-6, 2024. The company will showcase data from its comprehensive TransportNPC™ Phase 3 global trial, focusing on Niemann-Pick Disease Type C1 (NPC1). One poster will discuss the safety data, patient cohort data, neurological outcomes, and novel assessment technologies for patients aged three years and older. Another poster will cover an open-label sub-study for patients below three years of age, emphasizing safety, clinical endpoints, early intervention, and disease prevention. CEO N. Scott Fine highlighted the study's global impact and the opportunity to engage with the NPC community at this key event.

Cyclo Therapeutics has completed enrollment for its Phase 3 TransportNPC™ trial, the largest study of its kind for Niemann-Pick Disease Type C1 (NPC1). The study includes 104 patients and aims to evaluate the efficacy of Trappsol® Cyclo™ in treating systemic and neurological symptoms of NPC1.

Topline data from the 48-week interim analysis is expected in the first half of 2025. Positive results could lead to the submission of a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the EMA in the second half of 2025.

The trial also features a substudy for newborns to 3-year-olds, targeting early-stage interventions. The company has received Orphan Drug Designation in both the U.S. and EU, Fast Track and Rare Pediatric Disease designations in the U.S., which could qualify them for a Priority Review Voucher.

Cyclo Therapeutics (Nasdaq: CYTH) reported its Q1 2024 financial results, highlighting ongoing progress in its TransportNPC™ Phase 3 study for Niemann-Pick Disease Type C1 (NPC1). The study expects to enroll the last patient by Q2 2024, with topline data anticipated in H1 2025. The company also received a U.S. patent for using Trappsol® Cyclo™ to treat Alzheimer's Disease.

Financially, Cyclo Therapeutics reported a net loss of $4.3 million for Q1 2024. However, research and development expenses decreased by 16% to $2.8 million due to reduced spending on the Alzheimer’s program and adjustments in personnel costs. The company ended the quarter with $2.9 million in cash.

Cyclo Therapeutics focuses on developing life-changing medicines, with Trappsol® Cyclo™ in multiple clinical trials for NPC1 and early Alzheimer’s disease.

Cyclo Therapeutics, Inc. (CYTH) reports progress in Phase 3 study for Niemann-Pick Disease Type C1 treatment, aligns with FDA, and ends 2023 with $9.2 million in cash. The company aims to provide earlier access to efficacious treatments, bolster cash position, and extend runway through clinical milestones.

Cyclo Therapeutics, Inc. (CYTH) secures U.S. Patent for treating Alzheimer's disease with Trappsol® Cyclo™, aiming to address the unmet medical need. The company is dedicated to developing life-changing medicines through innovation.

Cyclo Therapeutics, Inc. (CYTH) received a Notice of Allowance from the USPTO for its U.S. Patent Application titled 'Methods for Treating Alzheimer’s Disease.' The CEO, N. Scott Fine, sees this as a significant milestone for the company's Alzheimer's disease asset and a valuable addition to its patent estate. The company remains hopeful about the potential of Trappsol® Cyclo™ in addressing the urgent need for innovative therapeutic solutions for early onset Alzheimer's disease.