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

Rhea-AI Summary

Cyclo Therapeutics (CYTH) reported a net loss of $3.5 million for Q2 2022, with R&D expenses decreasing 29% to $1.9 million. The company is advancing its clinical programs for Trappsol® Cyclo™, targeting Niemann-Pick Disease and Alzheimer’s Disease. The Phase 2 study for Alzheimer’s is set to begin by year-end, while the pivotal Phase 3 study for Niemann-Pick aims to enroll at least 93 patients across 9 countries. Cyclo Therapeutics holds Orphan Drug Designation in both the U.S. and EU for NPC1 and has a cash reserve of $7.5 million.

Positive

• On track to commence Phase 2 study of Trappsol® Cyclo™ for Alzheimer's Disease by year-end 2022.
• R&D expenses decreased by 29%, indicating better cost management.
• Engagement with NPC patient advocacy groups to advance clinical programs.

Negative

• Net loss of approximately $3.5 million for Q2 2022.
• Expecting R&D expenses to increase in 2022 as more resources are allocated to clinical trials.

– On track to commence Phase 2 study of Trappsol^® Cyclo™ for the treatment of Alzheimer’s Disease before year end

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

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 second quarter 2022 and provided a business update.

“Our primary focus remains on advancing our clinical programs evaluating Trappsol^® Cyclo™ for the treatment of NPC and Alzheimer’s disease. Of particular note over the past six months, we have spent dedicated time with the NPC patient advocacy organizations and have focused on building our presence in this community globally, which continues to be invaluable. We believe the engagement with the broader NPC community is integral to the continued successful execution of our pivotal program,” commented N. Scott Fine, CEO of Cyclo Therapeutics. “Additionally, we are making tremendous progress in gearing up for our Phase 2 Alzheimer’s disease study and are on track to enroll and dose patients before the end of this year. As we advance to the second half of the year, we are encouraged by the progress made thus far and look to continue driving value for all stakeholders in the near and long-term.”

Recent Highlights

• Presented at the 2022 China Nieman Pick Medical Exchange & Sixth Patient Association, a physician, researcher and patient focused event to discuss NPC and the latest research results for diagnosis and treatment;
• Attended the NNPDF-INPDA Conferences 2022 with Caroline Hastings, M.D., Key Opinion Leader in NPC and Global Principal Investigator for the ongoing TransportNPC™ study, to discuss Trappsol^® Cyclo™ and its clinical development program for the treatment of NPC;
• Provided an overview of the Trappsol® Cyclo™ program for the treatment of NPC at the World Orphan Drug Congress USA 2022;
• Presented an update on the results from Phase 1 and Phase 1/2 studies and launch of the international Phase 3 pivotal TransportNPC™ trial at the 2022 NPC Patient and Family Conference hosted by the Australian NPC Disease Foundation;
• Continued engagement with investment community and industry partners at the BIO International Convention; and
• Continued progress toward commencement of Phase 2 study of Trappsol^® Cyclo™ for the treatment of Alzheimer’s Disease in 2022.

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

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 is on track to commence this Phase 2 study and enroll patients this year.

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.

Pipeline Expansion Opportunities

In March 2022, the Company 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™.

The Collaboration consists of cooperative agreements in specific, undisclosed research and development, technology development and commercialization, and training projects, or any other activity agreed upon by Cyclo Therapeutics and Wits. Due to intellectual property development and for competitive reasons, Cyclo Therapeutics is not disclosing details related to the exploration of therapeutic areas or indications at this time.

Summary of Financial Results for Second Quarter 2022

Net loss for the quarter ended June 30, 2022 was approximately $3.5 million. Research and development expenses decreased 29% to approximately $1.9 million for the three months ended June 30, 2022, from $2.6 million for the three months ended June 30, 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. The Company expects research and development 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 $7.5 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
		June 30, 2022			December 31, 2021
		(unaudited)
ASSETS
CURRENT ASSETS
Cash and cash equivalents	$	7,453,391			$	16,612,711
Accounts receivable, net		409,932				493,113
Inventory, net		260,613				227,437
Current portion of mortgage note receivable		28,762				45,977
Prepaid insurance and services		186,217				42,246
Prepaid clinical expenses		3,438,121				2,014,851
Total current assets		11,777,036				19,436,335
FURNITURE AND EQUIPMENT, NET		54,701				59,583
RIGHT-TO-USE LEASE ASSET, NET		10,078				17,636
MORTGAGE NOTE RECEIVABLE, LESS CURRENT PORTION		-				7,279
TOTAL ASSETS	$	11,841,815			$	19,520,833
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES
Current portion of lease liability	$	9,805			$	19,245
Current portion of note payable		-				133,712
Accounts payable and accrued expenses		2,091,968				3,677,979
Total current liabilities		2,101,773				3,830,936
LONG-TERM LIABILITIES
Long-term note payable, less current portion		-				18,034
Commitments and contingencies
STOCKHOLDERS' EQUITY
Common stock, par value $.0001 per share, 20,000,000 shares authorized, 8,439,435 and 8,403,869 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively		844				841
Preferred stock, par value $.0001 per share, 5,000,000 shares authorized, 0 issued and outstanding		-				-
Additional paid-in capital		64,311,270				64,019,513
Accumulated deficit		(54,572,072	)			(48,348,491	)
Total stockholders' equity		9,740,042				15,671,863
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$	11,841,815			$	19,520,833

CYCLO THERAPEUTICS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
	Three Months Ended								Six Months Ended
	June 30,								June 30,
	2022				2021				2022				2021
REVENUES
Product sales	$	541,886			$	238,590			$	736,790			$	596,723
EXPENSES
Personnel		970,759				542,192				2,187,664				1,101,516
Cost of products sold (exclusive of direct and indirect overhead and handling costs)		73,667				30,158				90,131				64,754
Research and development		1,874,383				2,643,544				2,958,435				5,901,659
Repairs and maintenance		3,675				1,647				7,998				3,313
Professional fees		649,842				373,618				1,061,897				596,489
Office and other		291,611				241,739				585,787				555,513
Board of Director fees and costs		124,131				-				216,256				-
Depreciation		4,741				4,863				9,482				8,413
Freight and shipping		5,101				1,281				9,621				2,794
Total operating expenses		3,997,910				3,839,042				7,127,271				8,234,451
LOSS FROM OPERATIONS		(3,456,024	)			(3,600,452	)			(6,390,481	)			(7,637,728	)
OTHER INCOME
Investment and other income		4,034				3,054				8,376				3,715
Gain on forgiveness of PPP loan		-				-				158,524				-
Total other income		4,034				3,054				166,900				3,715
LOSS BEFORE INCOME TAXES		(3,451,990	)			(3,597,398	)			(6,223,581	)			(7,634,013	)
PROVISION FOR INCOME TAXES		-				-				-				-
NET LOSS	$	(3,451,990	)		$	(3,597,398	)		$	(6,223,581	)		$	(7,634,013	)
BASIC AND DILUTED NET LOSS PER COMMON SHARE	$	(0.41	)		$	(0.56	)		$	(0.74	)		$	(1.31	)
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING		8,424,003				6,368,025				8,417,901				5,842,100

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20220816005241/en/

Investor Contact:

JTC Team, LLC

Jenene Thomas

(833) 475-8247

CYTH@jtcir.com

Source: Cyclo Therapeutics, Inc.

FAQ

What are the financial results for Cyclo Therapeutics for Q2 2022?

Cyclo Therapeutics reported a net loss of approximately $3.5 million for Q2 2022.

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

Cyclo Therapeutics is on track to commence the Phase 2 study of Trappsol® Cyclo™ for Alzheimer's Disease before the end of 2022.

What are the key highlights from Cyclo Therapeutics' recent press release?

Key highlights include the start of Phase 2 Alzheimer’s study, ongoing Phase 3 study for Niemann-Pick Disease, and a decrease in R&D expenses by 29%.

How many patients are being enrolled in the TransportNPC™ study?

The TransportNPC™ study aims to enroll at least 93 patients with Niemann-Pick Disease Type C1.

What is the cash position of Cyclo Therapeutics as of Q2 2022?

As of Q2 2022, Cyclo Therapeutics ended the quarter with approximately $7.5 million in cash.