Cyclo Therapeutics, Inc. (CYTH) Bundle
Ever wondered about the story behind Cyclo Therapeutics, Inc. (CYTH), a clinical-stage biotechnology company making waves in the pharmaceutical world? With a focus on developing cyclodextrin-based therapies, primarily for rare neurodegenerative diseases like Niemann-Pick Type C (NPC), Cyclo Therapeutics is striving to improve the lives of patients facing debilitating conditions. But how exactly did this company get its start, who owns it, and what's the master plan for making a profit? Keep reading to discover the fascinating details behind Cyclo Therapeutics' history, ownership, mission, and innovative approach to treating complex diseases.
Cyclo Therapeutics, Inc. (CYTH) History
Cyclo Therapeutics, Inc.'s Founding Timeline
Year established
Cyclo Therapeutics, Inc. was founded in 1980.
Original location
The company is headquartered in Gainesville, Florida.
Founding team members
While specific names of the original founding members are not widely publicized, the company's formation involved individuals with expertise in cyclodextrin technology and pharmaceutical development.
Initial capital/funding
Details on the initial capital and funding sources at the time of the company's founding are not readily available in the public domain.
Cyclo Therapeutics, Inc.'s Evolution Milestones
Year | Key Event | Significance |
---|---|---|
1980 | Company Founded | Established a base for cyclodextrin research and applications. |
1990s | Focus on Cyclodextrin Applications | Shifted focus towards using cyclodextrins to improve drug delivery and solubility. |
2019 | Orphan Drug Designation for Trappsol® Cyclo™ in Niemann-Pick Disease Type C (NPC) | Received Orphan Drug Designation from the FDA for Trappsol® Cyclo™ in treating NPC, providing market exclusivity and development incentives. |
2020 | Expanded Access Program for Trappsol® Cyclo™ | Initiated an expanded access program, allowing patients with NPC to access Trappsol® Cyclo™ before potential market approval. |
2021 | Data Presentations and Clinical Trials | Continued clinical trials and presented data on Trappsol® Cyclo™ for NPC, aiming to demonstrate efficacy and safety. |
2023 | Raising Capital via Registered Direct Offering | Secured approximately $7.0 million through a registered direct offering. The net proceeds were intended for working capital and general corporate purposes. |
2024 | Reverse Stock Split | Implemented a 1-for-10 reverse stock split, effective May 17, 2024. This action was intended to increase the company's stock price to regain compliance with Nasdaq's minimum bid price requirement. |
Cyclo Therapeutics, Inc.'s Transformative Moments
- Focus on Rare Diseases: A key transformative decision was the strategic focus on developing treatments for rare diseases, particularly Niemann-Pick Disease Type C. This focus allowed the company to pursue orphan drug designations, which provide significant benefits such as market exclusivity and tax credits.
- Development of Trappsol® Cyclo™: The development of Trappsol® Cyclo™ as a primary drug candidate marked a significant turning point. This specific formulation of cyclodextrin has become central to the company's clinical and commercialization efforts.
- Navigating Regulatory Pathways: Successfully navigating the regulatory pathways, including obtaining orphan drug designation and advancing through clinical trials, has been crucial. These efforts have required substantial investment and strategic planning.
- Capitalizing on Market Opportunities: Strategic decisions around raising capital, such as registered direct offerings and other financing activities, have been essential for funding ongoing research, clinical trials, and operational expenses.
To gain a deeper understanding of the company's financial status, consider exploring this resource: Breaking Down Cyclo Therapeutics, Inc. (CYTH) Financial Health: Key Insights for Investors
Cyclo Therapeutics, Inc. (CYTH) Ownership Structure
Understanding the ownership structure of Cyclo Therapeutics, Inc. provides valuable insights into its governance and strategic direction. The company's shares are held by a mix of institutional investors, individual shareholders, and company insiders.
Cyclo Therapeutics, Inc.'s Current Status
Cyclo Therapeutics, Inc. is a publicly traded company, meaning its shares are available for purchase by the general public on the stock market. As a publicly traded entity, it is subject to regulations and reporting requirements by the U.S. Securities and Exchange Commission (SEC).
Cyclo Therapeutics, Inc.'s Ownership Breakdown
The ownership of Cyclo Therapeutics, Inc. is distributed among various shareholders. Here’s a breakdown:
Shareholder Type | Ownership, % | Notes |
---|---|---|
Institutional Investors | 32.14% | Includes investment firms, mutual funds, and other institutions. |
Individual Investors | 58.53% | Represents a large base of retail investors. |
Insiders | 9.33% | Shares held by officers and directors. |
For more in-depth insights into investor profiles and their motivations, check out: Exploring Cyclo Therapeutics, Inc. (CYTH) Investor Profile: Who’s Buying and Why?
Cyclo Therapeutics, Inc.'s Leadership
The leadership team is responsible for the strategic direction and operational management of the company. Here are some of the key figures:
- N. Scott Fine: Chief Executive Officer
- Adolfo P. Arroyo, Jr.: Chief Financial Officer
Cyclo Therapeutics, Inc. (CYTH) Mission and Values
Cyclo Therapeutics, Inc. aims to improve the lives of patients with rare and debilitating diseases through the use of innovative therapies. The company is committed to developing and delivering life-changing medicines, driven by its core values of scientific excellence, patient focus, and integrity.
Cyclo Therapeutics, Inc.'s Core Purpose
Official mission statement
Cyclo Therapeutics' mission is centered on developing and delivering innovative therapies to improve the lives of patients with rare diseases. The company focuses on cyclodextrin-based products and technologies to address unmet medical needs.
- To develop and commercialize innovative therapies for rare and debilitating diseases.
- To utilize cyclodextrin technology to improve drug efficacy and safety.
- To address unmet medical needs in diseases with limited or no treatment options.
Vision statement
The vision of Cyclo Therapeutics is to be a leader in the development of cyclodextrin-based therapies, recognized for its commitment to patients, scientific excellence, and innovative solutions.
- To be a leading biotechnology company specializing in cyclodextrin-based therapies.
- To create significant value for patients, healthcare providers, and shareholders.
- To expand the application of cyclodextrin technology to new therapeutic areas.
Company slogan/tagline
While Cyclo Therapeutics doesn't have a singular, widely publicized slogan, their commitment to innovation and patient care is reflected in their work and communications. The absence of a specific slogan underscores the company's focus on tangible actions and results rather than marketing taglines.
More information about Cyclo Therapeutics, Inc. can be found here: Mission Statement, Vision, & Core Values of Cyclo Therapeutics, Inc. (CYTH).
Cyclo Therapeutics, Inc. (CYTH) How It Works
Cyclo Therapeutics, Inc. focuses on developing and delivering innovative therapies for rare and debilitating diseases, primarily using cyclodextrins to enhance the solubility and delivery of various therapeutic agents.
Cyclo Therapeutics, Inc.'s Product/Service Portfolio
Product/Service | Target Market | Key Features |
---|---|---|
Trappsol® Cyclo™ | Niemann-Pick Disease Type C (NPC) | A proprietary formulation of羟丙基-β-环糊精 designed to reduce cholesterol accumulation in cells. It is administered intravenously. |
Orphan Drug Designation | Rare Diseases | Offers market exclusivity and various incentives to encourage the development of treatments for rare diseases. |
Cyclo Therapeutics, Inc.'s Operational Framework
Cyclo Therapeutics operates through several key processes to develop and commercialize its therapies:
- Research and Development: The company invests in ongoing research to explore new applications of cyclodextrins and improve existing formulations.
- Clinical Trials: A significant portion of their operations involves conducting clinical trials to evaluate the safety and efficacy of Trappsol® Cyclo™ and other potential therapies.
- Regulatory Approval: They work closely with regulatory agencies like the FDA and EMA to secure approvals for their drugs, which is essential for commercialization.
- Manufacturing and Supply Chain: Ensuring a reliable supply of Trappsol® Cyclo™ involves managing the manufacturing process and supply chain.
- Patient Access Programs: Cyclo Therapeutics implements programs to provide access to their therapies for patients who need them, particularly in cases where the drug is not yet commercially available or affordable.
More information about the company's goals can be found here: Mission Statement, Vision, & Core Values of Cyclo Therapeutics, Inc. (CYTH).
Cyclo Therapeutics, Inc.'s Strategic Advantages
Cyclo Therapeutics possesses several strategic advantages that contribute to its potential for success:
- Proprietary Technology: Their expertise in cyclodextrin chemistry and drug formulation provides a competitive edge.
- Orphan Drug Designation: Trappsol® Cyclo™ has orphan drug designation in multiple regions, which provides market exclusivity and other benefits.
- Strong Intellectual Property: The company has patents and other intellectual property protecting their formulations and methods of use.
- Experienced Management Team: A team with experience in drug development, regulatory affairs, and commercialization is crucial for navigating the challenges of the pharmaceutical industry.
Cyclo Therapeutics, Inc. (CYTH) How It Makes Money
Cyclo Therapeutics, Inc. primarily generates revenue through the research, development, and commercialization of pharmaceutical products aimed at treating rare and orphan diseases. Their main focus is on using cyclodextrins to enhance the solubility and delivery of various therapeutic agents.
Cyclo Therapeutics, Inc.'s Revenue Breakdown
As a company deeply involved in clinical-stage drug development, revenue streams can vary significantly based on the progress of their drug candidates through clinical trials, regulatory approvals, and eventual commercialization. Given the nature of the company, detailed revenue breakdown by specific streams might not be available in typical financial reports, especially if the company has limited or no products on the market. However, revenue sources can be generally categorized.
Revenue Stream | % of Total | Growth Trend |
---|---|---|
Research Grants and Government Funding | Varies (depending on grant awards) | Fluctuating, based on successful grant applications |
Licensing Agreements & Milestone Payments | Varies (potential for significant impact upon successful milestones) | Potential for high growth upon achieving milestones |
Future Product Sales (Trappsol Cyclo™) | N/A (currently in development) | High potential upon FDA approval and commercialization |
Cyclo Therapeutics, Inc.'s Business Economics
The business economics of Cyclo Therapeutics, Inc. are heavily influenced by the high-risk, high-reward nature of pharmaceutical development. Key aspects include:
- R&D Expenses: A significant portion of their expenditure is allocated to research and development, particularly clinical trials for Trappsol Cyclo™, their lead drug candidate.
- Regulatory Approval: Achieving FDA approval is critical. The costs associated with clinical trials and regulatory submissions are substantial, but approval would unlock significant revenue potential.
- Orphan Drug Designation: Trappsol Cyclo™ has received orphan drug designation, which provides certain benefits such as market exclusivity and tax credits, incentivizing the development of treatments for rare diseases.
- Partnerships: Strategic alliances and partnerships can provide funding, expertise, and access to new markets, thereby spreading risk and enhancing commercial prospects.
Cyclo Therapeutics, Inc.'s Financial Performance
Evaluating Cyclo Therapeutics, Inc.'s financial performance requires a focus on key indicators that reflect the progress and potential of a clinical-stage pharmaceutical company:
- Cash Runway: Monitoring their cash reserves is crucial to assess their ability to fund ongoing clinical trials and operations until potential revenue streams materialize.
- Operating Expenses: Analyzing operating expenses, particularly R&D costs, provides insights into how efficiently the company is managing its resources.
- Net Losses: As a development-stage company, net losses are expected. However, the trend and magnitude of these losses indicate the burn rate and the need for additional financing.
- Financing Activities: Tracking financing activities, such as equity offerings or debt financing, is important to understand how the company is funding its operations and the potential dilution for existing shareholders.
For further insights into the financial health of Cyclo Therapeutics, Inc., consider exploring: Breaking Down Cyclo Therapeutics, Inc. (CYTH) Financial Health: Key Insights for Investors
Cyclo Therapeutics, Inc. (CYTH) Market Position & Future Outlook
Cyclo Therapeutics is navigating a complex pharmaceutical landscape, focusing on rare diseases with unmet medical needs. Their future outlook hinges on successful clinical trials and regulatory approvals, particularly for Trappsol® Cyclo™, while effectively managing financial resources to sustain operations.
Competitive Landscape
Company | Market Share, % | Key Advantage |
---|---|---|
Cyclo Therapeutics | ~1-3% | Focus on rare diseases and proprietary Trappsol® Cyclo™ |
Johnson & Johnson | ~15-18% | Diversified product portfolio and extensive global reach |
Pfizer | ~13-16% | Broad therapeutic areas and significant R&D investment |
Opportunities & Challenges
Opportunities | Risks |
---|---|
Orphan Drug Designation: Leverage regulatory benefits like market exclusivity and reduced fees to accelerate drug development and commercialization. | Clinical Trial Success: Dependence on positive outcomes from clinical trials for key drug candidates like Trappsol® Cyclo™. |
Expansion into New Markets: Explore geographical expansion and new indications for existing drugs to increase revenue streams. | Regulatory Hurdles: Navigating complex and evolving regulatory pathways for drug approvals in different regions. |
Strategic Partnerships: Collaborate with larger pharmaceutical companies or research institutions to share development costs and expertise. | Financial Stability: Maintaining sufficient cash flow to fund ongoing research and development activities. Cyclo Therapeutics reported having approximately $6.7 million in cash as of December 31, 2023. |
Industry Position
Cyclo Therapeutics occupies a niche position within the pharmaceutical industry, concentrating on rare and orphan diseases. Key aspects of their industry standing include:
- Niche Focus: Specialization in cyclodextrin-based therapies for rare diseases sets them apart from larger pharmaceutical companies.
- Proprietary Technology: Trappsol® Cyclo™, their main product, offers a unique approach to treating diseases like Niemann-Pick Disease Type C.
- Clinical Development Stage: As a company with products in clinical trials, their success is heavily reliant on positive trial outcomes and subsequent regulatory approvals.
To gain more insights into investor sentiment and potential market movements, explore: Exploring Cyclo Therapeutics, Inc. (CYTH) Investor Profile: Who’s Buying and Why?
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