GAINESVILLE, Fla.--(BUSINESS WIRE)--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 reported its financial results for the full year 2023 and provided a business update. “We made significant progress over the course of the past year. We continue to be extremely active with the NPC patient and scientific ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K Commission file number 0-25466 CYCLO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) | Nevada | 59-3029743 | | --- | --- | | (State or other jurisdiction of | (IRS Employer | | incorporation or organization) | Identification No.) | | 6714 NW 16th Street, Suite B, | | | Gainesville, Florida | 32653 | | (Address of principal executive offices) | (Zip Code) | Registrant's telephone number, including area ...

GAINESVILLE, Fla.--(BUSINESS WIRE)--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 the United States Patent and Trademark Office (USPTO) has granted U.S. Patent No. 11,925,659 titled, “Methods for Treating Alzheimer’s Disease,” with claims that cover the use of Trappsol® Cyclo™ for the preventio ...

GAINESVILLE, Fla.--(BUSINESS WIRE)--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 the Company received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) regarding Cyclo Therapeutics’ U.S. Patent Application No. 17/289,137 titled, “Methods for Treating Alzheim ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. C. 20549 FORM 10-Q ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended: September 30, 2023 or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from ____ to ____ Commission file number: 0-25466 CYCLO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) | Nevada | 59-3029743 | | --- | --- | ...

Financial Performance - Net losses for Q2 2023 were $4,636,455, compared to $3,451,990 in Q2 2022, representing a 34% increase in losses [111]. - Total revenues for Q2 2023 decreased by 78% to approximately $117,000, down from approximately $542,000 in Q2 2022 [112]. - Sales of Trappsol® Cyclo™ for Q2 2023 were approximately $58,000, a significant increase from $700 in Q2 2022 [112]. - Sales of Trappsol® HPB decreased by 84% in Q2 2023 to approximately $57,000 from approximately $357,000 in Q2 2022 [113]. - Cost of products sold for Q2 2023 decreased by 73% to approximately $20,000 from approximately $74,000 in Q2 2022 [117]. Research and Development - Research and development expenses increased by 69% to approximately $3,170,000 for Q2 2023, up from approximately $1,874,000 in Q2 2022 [121]. - Research and development expenses as a percentage of total operating expenses rose to 66% for the first half of 2023, compared to 42% in the same period of 2022 [121]. Expenses and Cash Flow - Personnel expenses decreased by 19% to approximately $785,000 for Q2 2023 from approximately $971,000 in Q2 2022 [120]. - Professional fees decreased by 36% to approximately $414,000 for Q2 2023, compared to approximately $650,000 in Q2 2022 [122]. - Cash decreased to $841,530 as of June 30, 2023, compared to $1,543,418 as of December 31, 2022 [125]. - Cash used in operations was approximately $7,849,000 for the six months ended June 30, 2023, compared to approximately $9,186,000 for the same period in 2022 [125]. Working Capital and Financing - Negative working capital was approximately $1,550,000 as of June 30, 2023, compared to positive working capital of approximately $678,000 at December 31, 2022 [125]. - The company will need to raise additional capital in the future to support ongoing operations and clinical trials [126]. - The ability to continue as a going concern is dependent upon the availability of equity financing [127]. Tax and Accounting - The company has approximately $42,395,000 in net state and federal operating loss carryforwards expiring from 2024 through 2037 [128]. - A 100% valuation allowance has been provided on the deferred tax asset based on expected future expenses related to clinical trials and development initiatives [128]. - There were no off-balance sheet arrangements as of June 30, 2023 [129]. - No significant changes to critical accounting policies occurred during the quarter ended June 30, 2023 [132].

Financial Performance - The company reported a net loss of approximately $5,007,085 for the three months ended March 31, 2023, compared to a net loss of approximately $2,772,000 for the same period in 2022, indicating a significant increase in losses [99]. - Total revenues for the three-month period ended March 31, 2023, decreased by 23% to approximately $150,000 compared to approximately $195,000 for the same period in 2022 [100]. - Sales of Trappsol® Cyclo™ for the three-month period ended March 31, 2023, were approximately $53,000, with no sales recorded for the same period in 2022, highlighting the product's orphan drug status [100]. Research and Development - Research and development expenses increased by 213% to approximately $3,398,000 for the three months ended March 31, 2023, from approximately $1,084,000 for the same period in 2022, reflecting increased activity in the Phase III study of Trappsol® Cyclo™ [109]. - The company received IND clearance from the FDA for a Phase II study of Trappsol® Cyclo™ for the treatment of Alzheimer's disease, with patient dosing beginning in Q1 2023 [96]. Financial Position - Cash decreased to approximately $915,176 as of March 31, 2023, compared to approximately $1,543,000 as of December 31, 2022, indicating liquidity challenges [112]. - The company had negative working capital of approximately $506,000 as of March 31, 2023, compared to positive working capital of approximately $678,000 at December 31, 2022 [112]. - As of December 31, 2022, the company had approximately $42,395,000 in net state and federal operating loss carryforwards, including $33,997,000 that will not expire, which can be utilized to offset future taxable net income [115]. - A 100% valuation allowance has been provided on the deferred tax asset due to expected future expenses related to clinical trials and development initiatives [115]. Operational Changes - Personnel expenses decreased by 25% to approximately $907,000 for the three months ended March 31, 2023, from approximately $1,217,000 for the same period in 2022, due to reallocation of personnel time [108]. - The company operates a legacy fine chemical business while transitioning to a biotechnology focus, primarily developing cyclodextrin-based biopharmaceuticals [98]. Capital and Financing - The company expects to continue raising additional capital through the sale of securities to fund ongoing operations and clinical trials, indicating reliance on external financing [113]. Accounting Policies - There were no off-balance sheet arrangements as of March 31, 2023 [116]. - No significant changes to critical accounting policies occurred during the quarter ended March 31, 2023 [118]. - The financial statements are prepared in accordance with U.S. generally accepted accounting principles, requiring judgments, estimates, and assumptions that may affect reported amounts [117].

Market Opportunity - The total addressable annual market for treating Niemann-Pick Type C disease (NPC) with Trappsol® Cyclo™ is estimated to be approximately $550 million, based on an average annual price of $404,750 for an intravenously administered drug [23]. - The incidence of NPC is estimated at one in 100,000 live births, with approximately 3,000 existing NPC patients worldwide and 1,370 new cases each year [23]. - The company’s legacy fine chemical business generates nearly all revenues, with Trappsol® products accounting for approximately 99% of 2022 product sales [100]. - The largest market for cyclodextrin applications is in food stabilization, with significant uses in pharmaceuticals, cosmetics, and diagnostics [103]. - The market for products containing cyclodextrins is expected to be substantially greater than the market sales of cyclodextrins themselves [108]. Clinical Trials and Efficacy - In a Phase I/II clinical study, 100% of patients who completed the trial (9 out of 12) improved or remained stable, with 89% meeting the efficacy outcome measure of improvement in at least two domains of the 17-domain NPC severity scale [13]. - The ongoing Phase III clinical trial (TransportNPC) involves 93 patients aged three and older, evaluating the efficacy of 2000 mg/kg doses of Trappsol® Cyclo™ administered bi-weekly compared to placebo [33]. - In the completed Phase I/II clinical study, 86% of patients (6 out of 7) met the efficacy endpoint of at least a one-point reduction in two or more domains of the NPC Clinical Severity Scale [35]. - Trappsol® Cyclo™ demonstrated a significant reduction in tau levels in cerebrospinal fluid, with six out of ten patients showing decreased levels after treatment [40]. - Trappsol® Cyclo™ has been administered to over 20 NPC patients in compassionate use programs, demonstrating benefits such as reduction in liver size and improvement in quality of life [29]. Regulatory Designations and Approvals - Trappsol® Cyclo™ has been designated as an orphan drug by the FDA, providing exclusive rights to sell the drug for seven years post-approval, and has also received Orphan Drug Designation in Europe, granting 10 years of market exclusivity [16]. - The FDA granted Fast Track designation to Trappsol® Cyclo™ for the treatment of NPC, facilitating expedited development and review [12]. - The designation of Trappsol® Cyclo™ as an orphan drug provides seven years of market exclusivity in the U.S. and 10 to 12 years in Europe following regulatory approval [44]. - The FDA may grant a seven-year period of marketing exclusivity for orphan drugs, preventing approval of similar products unless clinically superior [81]. - The FDA may accept data from foreign clinical trials in support of an NDA if they comply with GCP requirements [76]. Research and Development - The company is also exploring the use of Trappsol® Cyclo™ for the treatment of Alzheimer's disease, with a Phase II study initiated in early 2023 [18]. - Research and development expenses remained consistent at approximately $9 million in 2022, compared to $9.15 million in 2021, indicating stable investment in clinical programs [48]. - The company is committed to substantial investments in R&D to support its clinical trials, which commenced in 2017 [48]. - The company is exploring new applications for cyclodextrins in drug delivery systems, which could enhance the efficacy and safety of pharmaceutical products [102]. Business Strategy and Operations - The company continues to operate its legacy fine chemical business while transitioning to focus on cyclodextrin-based biopharmaceuticals for disease treatment [20]. - The company has established strong business relationships in the cyclodextrin market, providing a competitive advantage over smaller operations [46]. - The company has established business relationships with many producers and consumers of cyclodextrins worldwide, leveraging over 30 years of experience [46]. - The company has a finished product currently in use in human patients, enhancing its competitive position [45]. - The company is pursuing clinical programs in the U.S., Europe, North Africa, Australia, and Israel for market authorization of its bio-pharmaceutical product for NPC treatment [48]. Financial and Market Challenges - The company faces pressures from governmental and private payors regarding coverage and reimbursement levels, which could impact future product sales [91]. - Legislative and regulatory proposals aimed at controlling healthcare costs may adversely affect anticipated revenues from product candidates [97]. - The pharmaceutical industry faces pressures from healthcare reforms aimed at reducing costs and regulating drug pricing, which may impact profitability [92]. - The ACA established a nondeductible fee on manufacturers of specified branded prescription drugs, impacting the financial landscape for pharmaceutical companies [95]. - The company must comply with varying regulatory requirements in foreign markets to obtain marketing authorization, which can differ significantly from U.S. processes [98].

Financial Performance - The company reported net losses of approximately $4,247,000 and $10,470,000 for the three and nine months ended September 30, 2022, compared to net losses of approximately $3,860,000 and $11,494,000 for the same periods in 2021[120]. - Total revenues for the three-month period ended September 30, 2022, increased 12% to approximately $452,000 compared to approximately $404,000 for the same period in 2021; for the nine-month period, revenues increased 19% to approximately $1,189,000 compared to approximately $1,000,000 for the same period in 2021[121]. - Sales of Trappsol® Cyclo™ for the three-month period ended September 30, 2022, were $270, compared to $90 for the same period in 2021; for the nine-month period, sales decreased to $970 from $2,020[122]. - Sales of Trappsol® HPB increased by 18% for the three-month period ended September 30, 2022, to approximately $337,000 from approximately $286,000 for the same period in 2021; for the nine-month period, sales increased by 40% to approximately $759,000 from approximately $543,000[123]. Expenses - The cost of products sold for the three-month period ended September 30, 2022, increased 43% to approximately $33,000 from approximately $23,000 for the same period in 2021; for the nine-month period, it increased 41% to approximately $123,000 from approximately $87,000[128]. - Personnel expenses decreased by 47% to approximately $888,000 for the three months ended September 30, 2022, from approximately $1,668,000 for the same period in 2021; however, they increased by 11% for the nine-month period to approximately $3,075,000 from approximately $2,770,000[131]. - Research and development expenses increased 55% to approximately $2,856,000 for the three months ended September 30, 2022, from approximately $1,838,000 for the same period in 2021; however, they decreased 25% for the nine-month period to approximately $5,815,000 from approximately $7,739,000[133]. - Professional fees increased 36% to approximately $612,000 for the three months ended September 30, 2022, compared to approximately $450,000 for the same period in 2021; for the nine-month period, they increased 60% to approximately $1,674,000 from approximately $1,047,000[134]. - Office and other expenses decreased 16% to approximately $205,000 for the three months ended September 30, 2022, compared to approximately $244,000 for the same period in 2021[135]. Cash and Assets - Cash decreased to approximately $4,290,000 as of September 30, 2022, compared to approximately $16,613,000 as of December 31, 2021[137]. - Current assets less current liabilities were approximately $5,547,000 as of September 30, 2022, down from approximately $15,605,000 at December 31, 2021[137]. - Cash used in operations was approximately $12,367,000 for the nine months ended September 30, 2022, compared to approximately $12,394,000 for the same period in 2021[137]. Future Outlook - The company has approximately $37,510,000 in net state and federal operating loss carryforwards expiring from 2022 through 2037, including $29,000,000 that will not expire[141]. - The company expects to continue to raise additional capital through the sale of its securities to fund the development of drug product candidates[139]. - The company has provided a 100% valuation allowance on its deferred tax asset based on expected future expenses related to clinical trials[141]. - The company realized losses from operations but believes it will have sufficient cash to meet anticipated operating costs for at least the next 12 months[139]. - The consolidated financial statements were prepared on the basis of a going concern, dependent on the availability of equity financing[140]. Business Operations - The company continues to operate its legacy fine chemical business, with the three largest customers accounting for 67% of sales during the nine months ended September 30, 2022, compared to 65% in the same period of 2021[127]. - The company is exploring the use of cyclodextrins in the treatment of Alzheimer's disease, with an IND clearance from the FDA for a Phase II study expected to begin enrollment in 2022[117]. - The company had no off-balance sheet arrangements as of September 30, 2022[142].

NASDAQ: CYTH cyclotherapeutics.com Corporate Presentation 2 Forward-Looking Statements Some of the information in this presentation relates to future events or future business and financial performance. Such statements constitute forward-looking information within the meaning of the Private Securities Litigation Act of 1995. Such statements can be only predictions and the actual events or results may differ from those discussed due to, among other things, the risks described in the public filings and other ...