NEWS DETAIL

Cyclo Therapeutics Provides Business Update and Reports First Quarter 2022 Financial Results

- Continued advancement of lead development program evaluating Trappsol® Cyclo™ for Niemann-Pick Disease Type C1 (NPC1) in ongoing global pivotal study (TransportNPC™)

- Phase 2 study of Trappsol® Cyclo™ for the treatment of Alzheimer's Disease on track to commence patient enrollment this year

- Research collaboration with University of the Witwatersrand, Johannesburg (Wits) important step in further validating depth, breadth and utility of Trappsol® Cyclo™ as platform technology and ability to expand pipeline

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 first quarter 2022 and provided a business update.

“We are making solid progress across our clinical development programs and continue to gain momentum toward executing on the potential value-driving milestones ahead. Our leadership team, clinical team and Global Steering Committee of world-renowned experts remain focused on advancing our ongoing pivotal Phase 3 study evaluating Trappsol® Cyclo™ as a potential treatment for NPC, TransportNPC™. We are working towards the commencement of our Phase 2 study for our Alzheimer's disease program and are on track for initiating patient enrollment this year,” commented N. Scott Fine, CEO of Cyclo Therapeutics. “Additionally, an important milestone in the first quarter was the execution of our research collaboration with Wits. We believe this represents a catalytic step forward in not only validating the potential of our platform technology by preeminent researchers, but also enables us to understand the depth, breadth and utility of Trappsol® Cyclo™ in additional areas of unmet need in high-value indications.”

Recent Highlights

  • Entered into a research and collaboration agreement with the University of the Witwatersrand, Johannesburg (Wits) represented by Wits Commercial Enterprise (Pty) Ltd, a wholly owned subsidiary of the University whose mandate is to protect and manage the University's intellectual property. Under the terms of the collaboration agreement, Wits and Cyclo Therapeutics plan to develop and coordinate projects or activities to further scientific advancement of the Company's proprietary platform technology, Trappsol® Cyclo™; and
  • Continued progress toward advancing clinical development program evaluating Trappsol® Cyclo™ for the treatment of Alzheimer's Disease into Phase 2 study.

Trappsol® Cyclo™ Clinical Program Update

Trappsol® Cyclo™ is a proprietary formulation of hydroxypropyl beta cyclodextrin, used intravenously (IV) and currently in development for the treatment of NPC, a rare genetic disorder causing cholesterol accumulation in lysosomes of cells, organ dysfunction and premature death.

Niemann-Pick Disease Type C1 Development Program

In June 2021, the Company commenced the TransportNPC™ study evaluating Trappsol® Cyclo™ for the treatment of NPC1, a rare, progressive and fatal genetic disorder. Initial sites are in the U.S.

The Company's ongoing pivotal Phase 3 study, TransportNPC™, is a randomized, double-blind, placebo-controlled, parallel group, multicenter study designed to evaluate the safety, tolerability, and efficacy of 2,000 mg/kg doses of Trappsol® Cyclo™ administered intravenously and standard of care (SOC), compared to placebo administered intravenously and SOC alone, in patients with NPC1. The Phase 3 study intends to enroll at least 93 pediatric (age 3 years and older) and adult patients with NPC1 in at least 23 study centers in 9 countries. Eligible patients will be randomized 2:1 to receive either Trappsol® Cyclo™ or a placebo. Randomization will not be constrained based on patient age, nor will patient enrollment be gated by patient age. The study duration is 96 weeks and includes an interim analysis at 48 weeks. Data seen to-date provide additional support for the capacity of Trappsol® Cyclo™ to stabilize disease progression with home-based intravenous infusions as well as for a favorable safety profile of more than two years in NPC.

The Company recently established a Global Steering Committee (GSC) to guide the pivotal Phase 3 global clinical development program of Trappsol® Cyclo™ for the treatment of NPC. As the Global Principal Investigator for the TransportNPC™ study, Caroline Hastings, MD serves as the senior scientific and clinical expert for the trial and chair of the GSC. Other members of the Companies GSC include leading experts and renowned Key Opinion Leaders.

Additionally, Cyclo Therapeutics received a positive opinion from the Paediatric Committee (PDCO) of the EMA and agreement on its Paediatric Investigation Plan (PIP) for Trappsol® Cyclo™. The PIP opinion from PDCO endorsed the clinical program to evaluate the safety, tolerability and efficacy of Trappsol® Cyclo™ in patients from 3 to less than 18 years of age with NPC in the randomized study, and in addition, to include a single-arm open-label sub-study of patients from birth to less than 3 years of age with NPC Type C1 irrespective of symptoms to evaluate safety and to obtain descriptive data on global disease severity and the response to Trappsol® Cyclo™. The sub-study in patients from birth to less than 3 years of age will only be conducted in the EU and countries following EMA guidelines.

For more information about the Company's TransportNPC™ pivotal Phase 3 study, visit www.ClinicalTrials.gov and reference identifier NCT04860960.

Cyclo Therapeutics received Orphan Drug Designation for Trappsol® Cyclo™ to treat NPC1 in both the U.S. and EU and Fast Track and Rare Pediatric Disease Designations in the U.S. The Rare Pediatric Disease Designation is one of the chief requirements for sponsors to receive a Priority Review Voucher in the U.S. upon marketing authorization.

Alzheimer's Disease Asset

Cyclo Therapeutics is also planning to evaluate Trappsol® Cyclo™ for the treatment of Alzheimer's Disease, targeting the reduction of amyloid beta and tau. To assist in driving the development program forward, the Company recently appointed Cynthia A. Lemere, PhD, a renowned translational researcher focused on understanding, preventing, and treating Alzheimer's disease, as the Senior Advisor for the Company's Alzheimer's Disease program. In December 2021, the Company received IND clearance from the U.S. FDA to advance its Phase 2 study of intravenous Trappsol® Cyclo™ for the treatment of early Alzheimer's Disease. The Company expects to commence this Phase 2 study and enroll patients in 2022.

Many of the known risk factors for Alzheimer's disease are associated with cholesterol metabolism. Cholesterol imbalance in Alzheimer's patients is well known, and significant research exists, suggesting these imbalances are responsible for amyloid beta (Aβ) and tau accumulation. Furthermore, neurons, because of their high metabolic demands, experience an increased level of oxidative stress. Oxidative stress has also been linked to abnormal cholesterol accumulation and processing.

Summary of Financial Results for First Quarter 2022

Net loss for the quarter ended March 31, 2022 was approximately $2.8 million. Research and development expenses decreased 67% to $1.1 million for the three months ended March 31, 2022, from $3.3 million for the three months ended March 31, 2021. The decrease in research and development expense in the more recent period was related to the timing of startup costs in our clinical programs in the prior year period. Prepaid clinical expense increased by $1.4 million. The increase in prepaid clinical expense was due to the operationalization of the Alzheimer's Disease trial and an investment in establishing commercial manufacturing capabilities. The Company expects research and development and prepaid clinical expenses to further increase in 2022 as we continue to seek regulatory approval for the use of Trappsol® Cyclo™ in the treatment of NPC and Alzheimer's disease.

The Company ended the quarter with approximately $11.8 million of cash.

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 suffering from 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 C, a rare and fatal genetic disease, (www.ClinicalTrials.gov NCT02939547, NCT02912793, NCT03893071 and NCT04860960). The Company is planning an early phase clinical trial using Trappsol® Cyclo™ intravenously in Alzheimer's Disease based on encouraging data from an Expanded Access program for late-onset 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.

CYCLO THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

   

 

March 31,
2022

December 31,
2021

(unaudited)

 

ASSETS

     

 

CURRENT ASSETS

 

Cash and cash equivalents

$

11,798,556

$

16,612,711

Accounts receivable, net

118,375

493,113

Inventory, net

221,056

227,437

Current portion of mortgage note receivable

39,340

45,977

Prepaid insurance and services

231,614

42,246

Prepaid clinical expenses

3,441,285

2,014,851

Total current assets

15,850,226

19,436,335

FURNITURE AND EQUIPMENT, NET

59,442

59,583

RIGHT-TO-USE LEASE ASSET, NET

14,488

17,636

MORTGAGE NOTE RECEIVABLE, LESS CURRENT PORTION

-

7,279

TOTAL ASSETS

$

15,924,156

$

19,520,833

LIABILITIES AND STOCKHOLDERS' EQUITY

     

CURRENT LIABILITIES

Current portion of lease liability

$

14,560

$

19,245

Current portion of PPP loan

-

133,712

Accounts payable and accrued expenses

2,861,582

3,677,979

Total current liabilities

2,876,142

3,830,936

LONG-TERM LIABILITIES

Long-term PPP loan, less current portion

-

18,034

Commitments and contingencies

STOCKHOLDERS' EQUITY

Common stock, par value $.0001 per share, 20,000,000 shares authorized, 8,415,196 and 8,403,869 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively

842

841

Preferred stock, par value $.0001 per share, 5,000,000 shares authorized, 0 issued and outstanding

-

-

Additional paid-in capital

64,167,254

64,019,513

Accumulated deficit

(51,120,082

)

(48,348,491

)

Total stockholders' equity

13,048,014

15,671,863

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

$

15,924,156

$

19,520,833

Contacts

Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
[email protected]

CYCLO THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

Three Months Ended
March 31,

2022

2021

REVENUES

Product sales

$

194,904

$

358,133

EXPENSES

Personnel

1,216,905

559,324

Cost of products sold (exclusive of direct and indirect overhead and handling costs)

16,464

34,596

Research and development

1,084,052

3,258,115

Repairs and maintenance

4,323

1,666

Professional fees

412,055

222,871

Office and other

294,176

313,774

Board of Directors fees and costs

92,125

-

Depreciation

4,741

3,550

Freight and shipping

4,520

1,513

Total operating expenses

3,129,361

4,395,409

LOSS FROM OPERATIONS

(2,934,457

)

(4,037,276

)

OTHER INCOME

Investment and other income

4,342

661

Gain on forgiveness of PPP loan

158,524

-

Total other income

162,866

661

LOSS BEFORE INCOME TAXES

(2,771,591

)

(4,036,615

)

PROVISION FOR INCOME TAXES

-

-

NET LOSS

$

(2,771,591

)

$

(4,036,615

)

BASIC AND DILUTED NET LOSS PER COMMON SHARE

$

(0.33

)

$

(0.76

)

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING

8,411,798

5,333,806