Cyclo Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update
- Progress in pivotal Phase 3 study (TransportNPC™) for Niemann-Pick Disease Type C1 treatment
- Alignment with FDA to enable earlier access to efficacious treatments
- Ended 2023 with approximately $9.2 million in cash
- Focus on bolstering cash position and extending runway through clinical and regulatory milestones
- Net loss for the year ended December 31, 2023, was approximately $20.1 million
- Research and development expenses increased by 58% to $14.2 million for the year ended December 31, 2023
- The company ended the year with a cash balance of approximately $9.2 million
Insights
The financial results of Cyclo Therapeutics, particularly the net loss of $20.1 million, reflect a substantial increase in research and development (R&D) expenses, which rose by 58% year-over-year. This uptick is attributed to the progression of their Phase 3 study for Trappsol® Cyclo™ in treating Niemann-Pick Disease Type C1 (NPC1). Investors should note the company's strategic focus on R&D as it could signal potential for future growth if the treatment proves successful and gains market approval. However, the significant net loss and cash burn rate, with only $9.2 million in cash reserves, may raise concerns about the company's financial sustainability and the need for additional capital infusion.
The advancement of Trappsol® Cyclo™ in a pivotal Phase 3 study is a critical step for Cyclo Therapeutics in addressing the unmet need in the NPC1 patient population. The positive engagement with the FDA and the alignment on development strategy suggest a favorable regulatory pathway. The potential early access for patients could expedite the drug's time to market, subject to interim analysis data and final study outcomes. While this is promising, the actual impact on the company's valuation will heavily depend on the interim results expected in Q1 2025 and the drug's efficacy and safety profile. The grant of a U.S. patent for the treatment of Alzheimer's Disease could also broaden the drug's applicability, potentially increasing its market value.
The strategic merger with Applied Molecular Transport Inc. and the granted U.S. patent for Alzheimer's Disease treatment may position Cyclo Therapeutics favorably within the biotechnology sector. The diversification of their portfolio and the patent could provide a competitive edge and open additional revenue streams. However, the market's response to these developments will likely remain cautious until the interim analysis data are released. The biotech sector is highly volatile and investor sentiment can shift rapidly based on clinical outcomes. Thus, the long-term impact on the stock market and the company's market capitalization will be contingent on the successful completion of clinical trials and subsequent commercialization efforts.
Continued progress of pivotal Phase 3 study (TransportNPC™) evaluating Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C1 (NPC1) toward 48-week comparative interim analysis data readout, planned for Q1 2025
Aligned development strategy for Trappsol® Cyclo™ with FDA to enable a patient population lacking available therapies to have earlier access to a potentially efficacious product with an acceptable safety profile
Ended the year with approximately
“We made significant progress over the course of the past year. We continue to be extremely active with the NPC patient and scientific communities and believe these valuable interactions underscore the progress we have seen with the advancement of our TransportNPC study,” commented N. Scott Fine, Chief Executive Officer of Cyclo Therapeutics. “Following the completion of the merger with Applied Molecular Transport, we are poised to continue building momentum and achieving the value-driving milestones ahead. Importantly, supported with the positive feedback from FDA and alignment on our strategy moving forward, we remain focused on generating the appropriate data required to successfully drive our TransportNPC study across the finish line and the potential to provide a much-needed treatment option for the NPC community. We are grateful for the continued support of our investors, including Rafael Holdings and other longtime shareholders, who have bolstered our cash runway and helped position us to achieve our mission and continue our work to advance the clinical development of Trappsol® Cyclo™.”
William Conkling, Chief Executive Officer of Rafael Holdings, Inc., added, “We are pleased with the continued clinical progress and operational execution and look forward to the continued advancement of those efforts in 2024.”
Recent Highlights
-
Granted
U.S. patent covering use of Trappsol® Cyclo™ for treatment of Alzheimer's Disease from theU.S. Patent and Trademark Office; - Completed merger with Applied Molecular Transport Inc to focus on advancing Cyclo Therapeutics’ pivotal Phase 3 global study, TransportNPC™, evaluating Trappsol® Cyclo™ for NPC;
- Dr. Caroline Hastings, Chair of the Company’s Phase 3 Trappsol® Cyclo™ program steering committee and Global Principal Investigator for the Company’s ongoing TransportNPC™ study presented at the 20th Annual WORLDSymposium™; and
-
Announced positive outcome from Type C Meeting with the
U.S. FDA discussing Trappsol® Cyclo™ clinical program for the treatment of Niemann-Pick Disease Type C1. -
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
Summary of Financial Results for the Full Year 2023
Net loss for the year ended December 31, 2023 was approximately
The Company ended the year with approximately
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
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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Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
CYTH@jtcir.com
Source: Cyclo Therapeutics, Inc.
FAQ
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