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

Rhea-AI Summary

Cyclo Therapeutics (CYTH) reported Q1 2022 financial results, including a net loss of approximately $2.8 million. The company is advancing its lead program, Trappsol® Cyclo™, in a pivotal Phase 3 study for Niemann-Pick Disease Type C1 (NPC1) and plans to initiate a Phase 2 study for Alzheimer's Disease this year. Recent collaborations with the University of the Witwatersrand aim to expand the use of Trappsol® Cyclo™. Research and development expenses decreased by 67% to $1.1 million, while prepaid clinical expenses rose by $1.4 million. Cash reserves stand at $11.8 million.

Positive

• Advancing pivotal Phase 3 study for Trappsol® Cyclo™ in NPC1.
• Phase 2 study for Alzheimer's Disease to commence patient enrollment this year.
• Collaboration with University of the Witwatersrand to enhance platform technology.

Negative

• Net loss of approximately $2.8 million for Q1 2022.
• Increased prepaid clinical expenses by $1.4 million, indicating higher operational costs.

- 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

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

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20220512006039/en/

Investor Contact:

JTC Team, LLC

Jenene Thomas

(833) 475-8247

CYTH@jtcir.com

Source: Cyclo Therapeutics, Inc.

FAQ

What were Cyclo Therapeutics' financial results for Q1 2022?

Cyclo Therapeutics reported a net loss of approximately $2.8 million for Q1 2022.

What is the status of the Trappsol® Cyclo™ study for NPC1?

The pivotal Phase 3 study for Trappsol® Cyclo™ is currently ongoing and is designed to evaluate safety and efficacy in patients with NPC1.

When will Cyclo Therapeutics start its Phase 2 study for Alzheimer's Disease?

Cyclo Therapeutics plans to commence patient enrollment for its Phase 2 study for Alzheimer's Disease within this year.

What collaboration has Cyclo Therapeutics entered into recently?

Cyclo Therapeutics executed a research collaboration agreement with the University of the Witwatersrand to advance the use of Trappsol® Cyclo™.