News

Cyclo Therapeutics Provides Business Update and Reports Third Quarter 2021 Financial Results

Nov 15, 2021

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

GAINESVILLE, Fla. –
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 third quarter of 2021, and provided a business update.

“We have executed on multiple fronts over the course of the third quarter. Our pivotal Phase 3 study evaluating Trappsol® Cyclo™ as a potential treatment for Niemann-Pick Disease, TransportNPC™, is now underway and we are pleased with the progress made thus far. Additionally, we’ve bolstered the leadership and expertise of our team with the appointments of our Chief Medical Officer and a Senior Advisor for the Alzheimer’s disease program, both of whom are world renowned, and we expect will add significant value as we look to advance Trappsol® Cyclo™ through the clinic and potentially to market,” commented N. Scott Fine, CEO of Cyclo Therapeutics. “Lastly, we continue to advance towards launching a Phase 2 study for our Alzheimer’s disease asset. We continue to execute on all fronts and are well-positioned for what we believe will be an exciting remainder of the year and beyond.”

Recent Highlights

  • Bolstered executive leadership team with appointment of Lise Lund Kjems, MD, PhD as Chief Medical Officer;
  • Named preeminent neuroscientist and world-renowned researcher, Cynthia A. Lemere, PhD, as Senior Advisor for advancement of Alzheimer’s Disease program; and
  • Announced new positive safety and efficacy data from ongoing Phase 1 open-label extension study of Trappsol® Cyclo™ for the treatment of NPC.

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 pivotal Phase 3 study 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.

The Company 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.

Additionally, Cyclo Therapeutics recently presented new long-term safety and efficacy data from its ongoing Phase 1 open-label extension study evaluating Trappsol® Cyclo™ for the treatment of NPC. The 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.

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. As part of a Type B interaction with the FDA, Cyclo Therapeutics received positive feedback supporting the Company’s development strategy to submit an IND application for a Phase 2 study of intravenous Trappsol® Cyclo™ in the treatment of early Alzheimer’s disease.

Summary of Financial Results for Third Quarter 2021

Net loss for the quarter ended September 30, 2021 was approximately $3.8 million. Research and development expenses increased 69% to $1.8 million for the three months ended September 30, 2021, from $1.1 million for the three months ended September 30, 2020. The increase in research and development expense is due to increased activity in the Company’s international clinical program and U.S. clinical trials. The Company expects research and development costs to further increase in 2021 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 $8.4 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.

— Financial Tables Follow-

CYCLO THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

September 30,

2021

December 31,

2020

(Unaudited)

ASSETS

CURRENT ASSETS

Cash and cash equivalents

$

8,441,297

$

12,846,113

Accounts receivable

354,864

71,017

Inventory, net

253,797

237,909

Current portion of mortgage note receivable

45,070

40,772

Prepaid insurance and services

92,483

126,474

Prepaid clinical expenses

1,804,664

727,952

Total current assets

10,992,175

14,050,237

FURNITURE AND EQUIPMENT, NET

63,790

53,910

RIGHT-TO-USE LEASE ASSET, NET

22,044

34,011

MORTGAGE NOTE RECEIVABLE, LESS CURRENT PORTION

18,520

49,806

TOTAL ASSETS

$

11,096,529

$

14,187,964

LIABILITIES AND STOCKHOLDERS’ EQUITY

CURRENT LIABILITIES

Current portion of lease liability

$

18,882

$

17,483

Current portion of note payable

106,836

114,029

Accounts payable and accrued expenses

3,293,869

3,541,041

Total current liabilities

3,419,587

3,672,553

LONG-TERM LIABILITIES

Long-term lease liability, less current portion

4,978

18,434

Long-term note payable, less current portion

44,910

44,495

Total long-term liabilities

49,888

62,929

STOCKHOLDERS’ EQUITY

Common stock, par value $.0001 per share, 20,000,000 shares authorized, 6,453,869 and 4,770,761 shares issued and outstanding, at September 30,2021 and December 31, 2020, respectively

646

477

Preferred stock, par value $.0001 per share, 5,000,000 shares authorized

–

–

Additional paid-in capital

53,182,513

44,513,841

Accumulated deficit

(45,556,105

)

(34,061,836

)

Total stockholders’ equity

7,627,054

10,452,482

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

$

11,096,529

$

14,187,964

CYCLO THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

Three Months Ended

Nine Months Ended

September 30,

September 30,

2021

2020

2021

2020

REVENUES

Product sales

$

403,918

$

222,462

$

1,000,641

$

757,790

EXPENSES

Personnel

1,668,010

424,823

2,769,526

1,328,156

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

22,671

11,578

87,425

50,958

Research and development

1,837,720

1,086,753

7,739,379

4,859,794

Repairs and maintenance

2,425

1,408

5,738

4,521

Professional fees

450,490

72,319

1,046,979

435,282

Office and other

244,343

48,202

799,856

306,387

Board of Director fees and costs

30,708

9,718

30,708

38,434

Depreciation

4,207

3,117

12,620

9,353

Freight and shipping

2,360

543

5,154

3,575

Bad debt expense

–

–

–

1,272

Total operating expenses

4,262,934

1,658,461

12,497,385

7,037,732

LOSS FROM OPERATIONS

(3,859,016

)

(1,435,999

)

(11,496,744

)

(6,279,942

)

OTHER INCOME (EXPENSE)

Investment and other income (expense)

(1,240

)

390

2,475

17,949

LOSS BEFORE INCOME TAXES

(3,860,256

)

(1,435,609

)

(11,494,269

)

(6,261,993

)

PROVISION FOR INCOME TAXES

–

–

–

–

NET LOSS

$

(3,860,256

)

$

(1,435,609

)

$

(11,494,269

)

$

(6,261,993

)

BASIC AND DILUTED NET LOSS PER COMMON SHARE

$

(0.60

)

$

(0.94

)

$

(1.90

)

$

(4.34

)

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING

6,447,803

1,519,457

6,040,524

1,443,109

JTC Team, LLC

Jenene Thomas

(833) 475-8247

CYTH@jtcir.com

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Trappsol® Cyclo™ is not currently approved for any indication.

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