- 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
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
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