UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D. C. 20549
FORM 10-Q
☒ Quarterly Report Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
For the quarterly period ended: September 30, 2020
or
☐ Transition Report Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
For the transition period from ____ to ____
Commission file number: 0-25466
CYCLO THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Nevada
|
|
59-3029743
|
(State or other jurisdiction of
incorporation or organization)
|
|
(IRS Employer
Identification No.)
|
6714 NW 16th Street,
Suite B, Gainesville, Florida
|
|
32653
|
(Address of principal executive offices)
|
|
(Zip Code)
|
Registrant's telephone number, including area code:
386-418-8060
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
|
|
Trading Symbol(s)
|
|
Name of each exchange on which registered
|
N/A
|
|
N/A
|
|
N/A
|
Indicate by check mark whether the registrant (1) has filed all
reports required to be filed by Section 13 or 15(d) of the Exchange
Act of 1934 during the preceding 12 months (or for such shorter
period that the registrant was required to file such reports), and
(2) has been subject to such filing requirements for the past 90
days. ☒
Yes ☐ No
Indicate by check mark whether the registrant has submitted
electronically every Interactive Data File required to be submitted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter)
during the preceding 12 months (or for such shorter period that the
registrant was required to submit such
files). ☒
Yes ☐ No
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer, a
smaller reporting company, or an emerging growth company. See
definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule
12b-2 of the Exchange Act.
|
Large accelerated filer
|
☐
|
Accelerated filer
|
☐
|
|
Non-accelerated filer
|
☒
|
Smaller reporting company
|
☒
|
|
|
|
Emerging growth company
|
☐
|
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act. ☐
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Exchange Act)
☐ Yes ☒ No
As of November 13, 2020 the Company had outstanding 169,982,602
shares of its common stock.
TABLE OF CONTENTS
|
Description
|
|
Page
|
|
|
|
|
PART I
|
FINANCIAL INFORMATION
|
|
1
|
Item 1.
|
Financial Statements.
|
|
1
|
|
Consolidated Balance Sheets as of September 30, 2020
(Unaudited) and December 31, 2019.
|
|
1
|
|
Consolidated Statements of Operations (Unaudited) for the three and
nine months ended September 30, 2020 and 2019.
|
|
2
|
|
Consolidated Statements of Stockholders’ Equity (Unaudited) for the
Three and Nine Months Ended September 30, 2020
|
|
3
|
|
Consolidated Statements of Stockholders’ Equity (Unaudited) for the
Three and Nine Months Ended September 30, 2019
|
|
4
|
|
Consolidated Statements of Cash Flows (Unaudited) for the nine
months ended September 30, 2020 and 2019.
|
|
5
|
|
Notes to Consolidated Financial Statements.
|
|
6
|
Item 2.
|
Management’s Discussion and Analysis of Financial Condition and
Results of Operations.
|
|
15
|
Item 3.
|
Quantitative and Qualitative Disclosures about Market Risk.
|
|
19
|
Item 4.
|
Controls and Procedures.
|
|
19
|
PART II
|
OTHER INFORMATION
|
|
20
|
Item 1A.
|
Risk Factors.
|
|
20
|
Item 6.
|
Exhibits.
|
|
20
|
|
|
|
|
SIGNATURES
|
|
21
|
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements.
CYCLO THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
|
|
September 30,
2020
|
|
|
December 31,
2019
|
|
|
|
(Unaudited)
|
|
|
|
|
|
ASSETS
|
|
CURRENT ASSETS
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
2,237,624 |
|
|
$ |
2,783,719 |
|
Accounts receivable
|
|
|
85,504 |
|
|
|
143,429 |
|
Inventory, net
|
|
|
421,324 |
|
|
|
242,630 |
|
Current portion of mortgage note receivable
|
|
|
39,061 |
|
|
|
39,061 |
|
Prepaid insurance and services
|
|
|
84,082 |
|
|
|
137,069 |
|
Prepaid clinical expenses
|
|
|
1,104,445 |
|
|
|
612,161 |
|
Total current assets
|
|
|
3,972,040 |
|
|
|
3,958,069 |
|
|
|
|
|
|
|
|
|
|
FURNITURE AND EQUIPMENT, NET
|
|
|
57,320 |
|
|
|
13,546 |
|
|
|
|
|
|
|
|
|
|
RIGHT-TO-USE LEASE ASSET, NET
|
|
|
38,348 |
|
|
|
51,017 |
|
|
|
|
|
|
|
|
|
|
MORTGAGE NOTE RECEIVABLE, LESS CURRENT PORTION
|
|
|
64,728 |
|
|
|
90,596 |
|
|
|
|
|
|
|
|
|
|
TOTAL ASSETS
|
|
$ |
4,132,436 |
|
|
$ |
4,113,228 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES
|
|
|
|
|
|
|
|
|
Current portion of lease liability
|
|
$ |
14,378 |
|
|
$ |
16,385 |
|
Current portion of long-term debt
|
|
|
87,421 |
|
|
|
- |
|
Accounts payable and accrued expenses
|
|
|
4,458,191 |
|
|
|
3,124,735 |
|
Total current liabilities
|
|
|
4,559,990 |
|
|
|
3,141,120 |
|
|
|
|
|
|
|
|
|
|
LONG-TERM LIABILITIES
|
|
|
|
|
|
|
|
|
Long-term lease liability, less current portion
|
|
|
25,876 |
|
|
|
36,126 |
|
Long-term debt, less current portion
|
|
|
71,103 |
|
|
|
- |
|
Total long-term liabilities
|
|
|
96,979 |
|
|
|
36,126 |
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS' EQUITY (DEFICIT)
|
|
|
|
|
|
|
|
|
Common stock, par value $.0001 per share, 500,000,000 shares
authorized, 169,876,130 and 121,564,990 shares issued and
outstanding, at September 30, 2020 and December 31, 2019
|
|
|
16,987 |
|
|
|
12,155 |
|
Preferred stock, par value $.0001 per share, 5,000,000 shares
authorized
|
|
|
|
|
|
|
- |
|
Additional paid-in capital
|
|
|
30,840,706 |
|
|
|
26,044,060 |
|
Accumulated deficit
|
|
|
(31,382,226 |
)
|
|
|
(25,120,233 |
)
|
Total stockholders' equity (deficit)
|
|
|
(524,533 |
)
|
|
|
935,982 |
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
(DEFICIT)
|
|
$ |
4,132,436 |
|
|
$ |
4,113,228 |
|
See accompanying Notes to Consolidated Financial
Statements
CYCLO THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REVENUES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales
|
|
$ |
222,462 |
|
|
$ |
285,914 |
|
|
$ |
757,790 |
|
|
$ |
779,835 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXPENSES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Personnel
|
|
|
424,823 |
|
|
|
520,666 |
|
|
|
1,328,156 |
|
|
|
1,241,742 |
|
Cost of products sold (exclusive of direct and indirect overhead
and handling costs)
|
|
|
11,578 |
|
|
|
25,971 |
|
|
|
50,958 |
|
|
|
62,830 |
|
Research and development
|
|
|
1,086,753 |
|
|
|
941,539 |
|
|
|
4,859,794 |
|
|
|
3,071,113 |
|
Repairs and maintenance
|
|
|
1,408 |
|
|
|
1,232 |
|
|
|
4,521 |
|
|
|
4,215 |
|
Professional fees
|
|
|
72,319 |
|
|
|
151,749 |
|
|
|
435,282 |
|
|
|
613,000 |
|
Office and other
|
|
|
48,202 |
|
|
|
233,555 |
|
|
|
306,387 |
|
|
|
583,692 |
|
Board of Director fees and costs
|
|
|
9,718 |
|
|
|
37,008 |
|
|
|
38,434 |
|
|
|
101,704 |
|
Depreciation
|
|
|
3,117 |
|
|
|
1,292 |
|
|
|
9,353 |
|
|
|
4,261 |
|
Freight and shipping
|
|
|
543 |
|
|
|
1,527 |
|
|
|
3,575 |
|
|
|
3,977 |
|
Bad debt expense
|
|
|
- |
|
|
|
- |
|
|
|
1,272 |
|
|
|
- |
|
Total operating expenses
|
|
|
1,658,461 |
|
|
|
1,914,539 |
|
|
|
7,037,732 |
|
|
|
5,686,534 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS FROM OPERATIONS
|
|
|
(1,435,999 |
)
|
|
|
(1,628,625 |
)
|
|
|
(6,279,942 |
)
|
|
|
(4,906,699 |
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER INCOME
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment and other income
|
|
|
390 |
|
|
|
3,284 |
|
|
|
17,949 |
|
|
|
9,181 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS BEFORE INCOME TAXES
|
|
|
(1,435,609 |
)
|
|
|
(1,625,341 |
)
|
|
|
(6,261,993 |
)
|
|
|
(4,897,518 |
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PROVISION FOR INCOME TAXES
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS
|
|
$ |
(1,435,609 |
)
|
|
$ |
(1,625,341 |
)
|
|
$ |
(6,261,993 |
)
|
|
$ |
(4,897,518 |
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC AND DILUTED NET LOSS PER COMMON SHARE
|
|
$ |
(.01 |
)
|
|
$ |
(.01 |
)
|
|
$ |
(0.04 |
) |
|
$ |
(.05 |
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
|
|
|
151,945,741 |
|
|
|
121,086,101 |
|
|
|
144,310,921 |
|
|
|
104,286,287 |
|
See Accompanying Notes to Consolidated Financial Statements.
CYCLO THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(DEFICIT)
FOR THE THREE AND NINE MONTHS ENDED
SEPTEMBER 30, 2020
(Unaudited)
|
|
Common Stock |
|
|
Additional |
|
|
|
|
|
Total |
|
|
|
Shares
|
|
|
Par
Value
|
|
|
Paid-In
Capital
|
|
|
Accumulated
Deficit
|
|
|
Stockholders’ Equity (Deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2019
|
|
|
121,564,990 |
|
|
$ |
12,155 |
|
|
$ |
26,044,060 |
|
|
$ |
(25,120,233 |
)
|
|
$ |
935,982 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(2,633,992 |
)
|
|
|
(2,633,992 |
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, March 31, 2020
|
|
|
121,564,990 |
|
|
|
12,155 |
|
|
|
26,044,060 |
|
|
|
(27,754,225 |
)
|
|
|
(1,698,010 |
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of common stock, net of issuance fees
|
|
|
20,000,000 |
|
|
|
2,000 |
|
|
|
1,968,363 |
|
|
|
- |
|
|
|
1,970,363 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(2,192,392 |
)
|
|
|
(2,192,392 |
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, June 30, 2020
|
|
|
141,564,990 |
|
|
|
14,155 |
|
|
|
28,012,423 |
|
|
|
(29,946,617 |
)
|
|
|
(1,920,039 |
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of common stock, net of issuance fees
|
|
|
28,311,140 |
|
|
|
2,832 |
|
|
|
2,828,283 |
|
|
|
- |
|
|
|
2,831,115 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,435,609 |
)
|
|
|
(1,435,609 |
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, September 30, 2020
|
|
|
169,876,130 |
|
|
$ |
16,987 |
|
|
$ |
30,840,706 |
|
|
$ |
(31,382,226 |
)
|
|
$ |
(524,533 |
)
|
See accompanying Notes to Consolidated Financial Statements.
CYCLO THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
FOR THE THREE AND NINE MONTHS ENDED
SEPTEMBER 30, 2019
(Unaudited)
|
|
Common Stock
|
|
|
Additional
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
Shares
|
|
|
Par
Value
|
|
|
Paid-In
Capital
|
|
|
Subscription
Receivable
|
|
|
Accumulated
Deficit
|
|
|
Stockholders’ Equity (Deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2018
|
|
|
90,759,324 |
|
|
$ |
9,075 |
|
|
$ |
18,701,211 |
|
|
$ |
(130,062 |
)
|
|
$ |
(17,587,700 |
)
|
|
$ |
992,524 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collection of subscription receivable
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
130,062 |
|
|
|
- |
|
|
|
130,062 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,904,166 |
)
|
|
|
(1,904,166 |
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, March 31, 2019
|
|
|
90,759,324 |
|
|
|
9,075 |
|
|
|
18,701,211 |
|
|
|
- |
|
|
|
(19,491,866 |
)
|
|
|
(781,580 |
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of common stock, net of issuance fees
|
|
|
29,770,000 |
|
|
|
2,977 |
|
|
|
6,986,623 |
|
|
|
- |
|
|
|
- |
|
|
|
6,989,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,368,011 |
)
|
|
|
(1,368,011 |
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, June 30, 2019
|
|
|
120,529,324 |
|
|
|
12,052 |
|
|
|
25,687,834 |
|
|
|
- |
|
|
|
(20,859,877 |
)
|
|
|
4,840,009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares of stock based compensation
|
|
|
585,666 |
|
|
|
58 |
|
|
|
268,521 |
|
|
|
- |
|
|
|
- |
|
|
|
268,579 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,625,341 |
)
|
|
|
(1,625,341 |
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, September 30, 2019
|
|
|
121,114,990 |
|
|
$ |
12,110 |
|
|
$ |
25,956,355 |
|
|
$ |
- |
|
|
$ |
(22,485,218 |
)
|
|
$ |
3,483,247 |
|
See accompanying Notes to Consolidated Financial Statements.
CYCLO THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
Nine Months Ended
|
|
|
|
September 30,
|
|
|
|
2020
|
|
|
2019
|
|
CASH FLOWS FROM OPERATING ACTIVITIES
|
|
|
|
|
|
Net loss
|
|
$ |
(6,261,993 |
)
|
|
$ |
(4,897,518 |
)
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
9,353 |
|
|
|
4,261 |
|
Accrued stock compensation to employees
|
|
|
6,630 |
|
|
|
104,100 |
|
Accrued stock compensation to non-employees
|
|
|
12,750 |
|
|
|
55,280 |
|
Increase or decrease in:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
57,925 |
|
|
|
44,302 |
|
Inventory
|
|
|
(178,694 |
)
|
|
|
32,420 |
|
Prepaid clinical expenses
|
|
|
(492,284 |
)
|
|
|
(217,395 |
)
|
Prepaid insurance and services
|
|
|
52,987 |
|
|
|
(2,519 |
)
|
Other
|
|
|
412 |
|
|
|
1,208 |
|
Accounts payable and accrued expenses
|
|
|
1,314,076 |
|
|
|
506,383 |
|
Total adjustments
|
|
|
783,155 |
|
|
|
528,040 |
|
|
|
|
|
|
|
|
|
|
NET CASH USED IN OPERATING ACTIVITIES
|
|
|
(5,478,838 |
)
|
|
|
(4,369,478 |
)
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES
|
|
|
|
|
|
|
|
|
Purchases of furniture and equipment
|
|
|
(53,127 |
)
|
|
|
(1,324 |
)
|
Proceeds from mortgage note receivable
|
|
|
25,868 |
|
|
|
27,943 |
|
|
|
|
|
|
|
|
|
|
NET CASH PROVIDED BY (USED IN) INVESTING
ACTIVITIES
|
|
|
(27,259 |
)
|
|
|
26,619 |
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES
|
|
|
|
|
|
|
|
|
Proceeds from PPP loan
|
|
|
158,524 |
|
|
|
- |
|
Collection of stock subscription receivable
|
|
|
- |
|
|
|
130,062 |
|
Net proceeds from sale of common stock and warrants, net of issue
costs
|
|
|
4,801,478 |
|
|
|
6,989,600 |
|
|
|
|
|
|
|
|
|
|
NET CASH PROVIDED BY FINANCING ACTIVITIES
|
|
|
4,960,002 |
|
|
|
7,119,662 |
|
|
|
|
|
|
|
|
|
|
NET INCREASE (DECREASE) IN CASH AND
CASH EQUIVALENTS
|
|
|
(546,095 |
)
|
|
|
2,776,803 |
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS, beginning of period
|
|
|
2,783,719 |
|
|
|
2,217,412 |
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS, end of period
|
|
$ |
2,237,624 |
|
|
$ |
4,994,215 |
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
|
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
$ |
224 |
|
|
$ |
- |
|
Cash paid for income taxes
|
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
NON-CASH INVESTING AND FINANCING ACTIVITIES
|
|
|
|
|
|
|
|
|
Capitalization of right-to-use asset and lease liability
|
|
$ |
- |
|
|
$ |
56,476 |
|
See Accompanying Notes to Consolidated Financial Statements.
CYCLO THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2020
The information presented herein as of September 30, 2020 and
for the nine months ended September 30, 2020 and 2019 is
unaudited.
(1) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:
The following is a summary of the more significant accounting
policies of Cyclo Therapeutics, Inc. (the “Company,” “we,”
“our” or “us”) that affect the accompanying consolidated financial
statements:
(a) ORGANIZATION AND OPERATIONS––The Company was incorporated in
August 1990 as a Florida corporation, under the name Cyclodextrin
Technologies Development, Inc. with operations beginning in July
1992. In conjunction with a restructuring in 2000, we changed our
name to CTD Holdings, Inc. We changed our name to Cyclo
Therapeutics, Inc. in September 2019 to better reflect our current
business, and in November 2020 we reincorporated from the State of
Florida to the State of Nevada. (See also Note 10.) We are a
clinical stage biotechnology company that develops
cyclodextrin-based products for the treatment of disease. We have
filed a Type II Drug Master File with the U.S. Food and Drug
Administration (“FDA”) for our lead drug candidate, Trappsol®
Cyclo™ as a treatment for Niemann-Pick Type C disease (“NPC”), a
rare and fatal cholesterol metabolism disease that impacts the
brain, lungs, liver, spleen, and other organs. The FDA approved our
Investigational New Drug application (IND) which describes our
Phase I clinical plans in the U.S. for Trappsol® Cyclo™ and in
January 2017 the FDA granted Fast Track designation to Trappsol®
Cyclo™ for the treatment of NPC. Initial patient enrollment
in the U.S. Phase I study commenced in September 2017. Enrollment
in this study was completed in October 2019, and in May 2020 the
Company announced Top Line data showing a favorable safety and
tolerability profile for Trappsol® Cyclo™ in this study.
We also filed Clinical Trial Applications with several European
regulatory bodies, including those in the United Kingdom, Sweden
and Italy, and in Israel, all of which have approved our
applications. The first patient was dosed in this study in July
2017, and in February 2020, the Company announced completion of
enrollment of 12 patients in this study. In May of 2020 the Company
announced interim results of this study showing a favorable safety
and tolerability profile for Trappsol® Cyclo™ as well as
encouraging signals in efficacy for all dose groups (1500 mg/kg,
2000 mg/kg and 2500 mg/kg) evaluated in this study. Additionally,
in February 2020 the Company had a face-to-face “Type C” meeting
with the FDA with respect to the initiation of a Phase III clinical
trial of Trappsol® Cyclo™
based on the clinical data obtained to date, and in October 2020,
the FDA notified us that we may proceed with the Phase III clinical
trial.
In addition, we are exploring the use of cyclodextrins in the
treatment of Alzheimer's disease, and in October 2019 entered into
an agreement with a Contract Research Organization to conduct a
clinical trial to evaluate the safety and efficacy of Trappsol®
Cyclo™ for the treatment of this disease.
We also sell cyclodextrins and related products to the
pharmaceutical, nutritional, and other industries, primarily for
use in diagnostics and specialty drugs. However, our core business
has transitioned to a biotechnology company primarily focused on
the development of cyclodextrin-based biopharmaceuticals for the
treatment of disease from a business which had been primarily
reselling basic cyclodextrin products.
(b) BASIS OF PRESENTATION––The consolidated financial statements
include the Company and its wholly owned subsidiaries. All
significant intercompany accounts and transactions have been
eliminated in consolidation. The interim consolidated financial
statements of the Company included in this Quarterly Report on Form
10-Q, including these notes, are unaudited. In the opinion of
management, all adjustments necessary for a fair presentation of
the consolidated financial statements have been included. Such
adjustments are of a normal, recurring nature. The consolidated
financial statements, and these notes, have been prepared in
accordance with GAAP and do not contain certain information
included in the Company’s Annual Report on Form 10-K for the fiscal
year ended December 31, 2019. The consolidated financial statements
should be read in conjunction with that Annual Report on Form 10-K.
Results for the interim periods presented are not necessarily
indicative of the results that might be expected for the entire
fiscal year.
(c) CASH AND CASH EQUIVALENTS––Cash and cash equivalents consist of
cash and any highly liquid investments with an original purchased
maturity of three months or less.
CYCLO THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2020
(1) SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES: (CONTINUED)
(d) ACCOUNTS RECEIVABLE––Accounts receivable are unsecured and
non-interest bearing and stated at the amount we expect to collect
from outstanding balances. Customer account balances with invoices
dated over 90 days old are considered past due. The Company does
not accrue interest on past due accounts. Customer payments are
allocated to the specific invoices identified on the customer’s
remittance advice or, if unspecified, applied to the oldest unpaid
invoices.
The carrying amount of accounts receivable are reduced by an
allowance for credit losses that reflects management’s best
estimate of the amounts that will not be collected. The Company
reviews each customer balance where all or a portion of the balance
exceeds 90 days from the invoice date. Based on the Company’s
assessment of the customer's current creditworthiness, the Company
estimates the portion, if any, of the balance that will not be
collected, and writes off receivables as a charge to the allowance
for credit losses when, in management’s estimation, it is probable
that the receivable is worthless. Based on management’s assessment
of the credit history with customers having outstanding balances
and current relationships with them, an allowance for doubtful
accounts was not deemed necessary at September 30, 2020 and
December 31, 2019.
(e) INVENTORY AND COST OF PRODUCTS SOLD––Inventory consists of our
pharmaceutical drug Trappsol® Cyclo™,
cyclodextrin products and chemical complexes purchased for resale
recorded at the lower of cost (first-in, first-out) or net
realizable value. Cost of products sold includes the acquisition
cost of the products sold and does not include any allocation of
outbound freight charges, indirect overhead expenses, warehouse and
distribution expenses, or depreciation and amortization expense.
The Company records a specific reserve for inventory items that are
determined to be obsolete. The reserve for obsolete inventory was
$52,922 at September 30, 2020 and December 31, 2019,
respectively. The Company’s reserve for obsolete inventory is based
on the Company’s best estimates of product sales and customer
demands. It is reasonably possible that the estimates used by the
Company to determine its provisions for inventory write-downs will
be materially different from actual write-downs. These differences
could result in materially higher than expected inventory
provisions and related costs, which could have a materially adverse
effect on the Company’s results of operations and financial
condition in the near term.
(f) PREPAID CLINICAL EXPENSES––Prepaid clinical expenses consist of
our pharmaceutical drug Trappsol® Cyclo™ expected to be used in our
clinical trial program recorded at cost.
(g) MORTGAGE NOTE RECEIVABLE––The mortgage note receivable is
stated at amortized value, which is the amount we expect to
collect.
(h) FURNITURE AND EQUIPMENT––Furniture and equipment are recorded
at cost, less accumulated depreciation. Depreciation is computed
using primarily the straight-line method over the estimated useful
lives of the assets (generally three to five years for computers
and vehicles and seven to ten years for machinery, equipment and
office furniture). We periodically review our long-lived assets to
determine if the carrying value of assets may not be recoverable.
If an impairment is identified, we recognize a loss for the
difference between the carrying amount and the estimated fair value
of the asset.
(i) REVENUE RECOGNITION––Under the revenue standards of ASC 606,
revenues are recognized when our customer obtains control of
promised goods or services, in an amount that reflects the
consideration which we expect to receive in exchange for those
goods or services. We recognize revenues following the five step
model prescribed under ASU No. 2014-09: (i) identify contract(s)
with a customer; (ii) identify the performance obligations in the
contract; (iii) determine the transaction price; (iv) allocate the
transaction price to the performance obligations in the contract;
and (v) recognize revenues when (or as) we satisfy the performance
obligation.
Product Revenues
In the U.S. and selected countries we sell our products to the end
user or wholesale distributors. In other countries, we also sell
our products to wholesale distributors and other third-party
distribution partners. These customers subsequently resell our
products to health care providers and patients.
CYCLO THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2020
(1) SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES: (CONTINUED)
Revenues from product sales are recognized when the customer
obtains control of our product, which occurs at a point in time,
typically upon delivery to the carrier. We expense incremental
costs of obtaining a contract as and when incurred if the expected
amortization period of the asset that we would have recognized is
one year or less or the amount is immaterial. We treat
shipping and handling costs performed after a customer obtains
control of the product as a fulfillment cost. We have identified
one performance obligation in our contracts with customers which is
the delivery of product to our customers. The transaction
price is recognized in full when we deliver the product to our
customer, which is the point at which we have satisfied our
performance obligation.
Reserves for Discounts and Allowances
Revenues from product sales are recorded net of reserves
established for applicable discounts and allowances that are
offered within contracts with our customers, health care providers
or payors, including those associated with the implementation of
pricing actions in certain of the international markets in which we
operate. Our process for estimating reserves established for these
variable consideration components do not differ materially from our
historical practices.
Product revenue reserves, which are classified as a reduction in
product revenues, are generally characterized in the following
categories: discounts, contractual adjustments and returns. These
reserves are based on estimates of the amounts earned or to be
claimed on the related sales and are classified as reductions of
accounts receivable (if the amount is payable to our customer) or a
liability (if the amount is payable to a party other than our
customer). Our estimates of reserves established for variable
consideration typically utilize the most likely method and reflect
our historical experience, current contractual and statutory
requirements, specific known market events and trends, industry
data and forecasted customer buying and payment patterns. The
transaction price, which includes variable consideration reflecting
the impact of discounts and allowances, may be subject to
constraint and is included in the net sales price only to the
extent that it is probable that a significant reversal of the
amount of the cumulative revenues recognized will not occur in a
future period. Actual amounts may ultimately differ from our
estimates. If actual results vary, we adjust these estimates, which
could have an effect on earnings in the period of adjustment. For
additional information on our revenues, please read Note 2,
Revenues, to these consolidated financial statements.
(j) SHIPPING AND HANDLING FEES––Shipping and handling fees, if
billed to customers, are included in product sales. Shipping and
handling costs associated with inbound and outbound freight are
expensed as incurred and included in freight and shipping
expense.
(k) ADVERTISING––Advertising costs are charged to operations when
incurred. We incur minimal advertising expenses.
(l) RESEARCH AND DEVELOPMENT COSTS––Research and development costs
are expensed as incurred.
(m) INCOME TAXES––Deferred tax assets and liabilities are
recognized for the estimated future tax consequences attributable
to differences between the financial statement carrying amounts of
existing assets and liabilities and their respective income tax
bases. Deferred tax assets and liabilities are measured using
enacted rates expected to apply to taxable income in the years in
which those temporary differences are expected to be recovered or
settled. In addition, tax benefits related to positions considered
uncertain are recognized only when it is more likely than not the
position will be sustained upon examination by the tax authorities.
Such tax positions shall initially and subsequently be measured as
the largest amount of tax benefit that has a greater than 50%
likelihood of being realized upon ultimate settlement with the tax
authority assuming full knowledge of the position and relevant
facts.
(n) NET LOSS PER COMMON SHARE––Basic and fully diluted net loss per
common share is computed using a simple weighted average of common
shares outstanding during the periods presented, as outstanding
warrants to purchase 93,622,864 common shares were antidilutive for
the three and nine months ended September 30, 2020 and
2019.
(o) STOCK BASED COMPENSATION–– The Company periodically awards
stock to employees, directors, and consultants. In the case of
employees and consultants, an expense is recognized equal to the
fair value of the stock determined using the closing trading price
of the stock on the award date. With respect to directors, the
Company accrues stock compensation expense on a quarterly basis
based on the Company’s historical director compensation policies,
and each quarter recognizes such expense based on the trading price
of the common stock during such quarter. This expense is then trued
up at the time the shares are issued to directors based on the
trading price at the time of issuance.
CYCLO THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2020
(1) SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES: (CONTINUED)
(p) FAIR VALUE MEASUREMENTS AND DISCLOSURES––The Fair Value
Measurements and Disclosures topic of the Accounting Standards
Codification (“ASC”) requires companies to determine fair value
based on the price that would be received to sell the asset or paid
to transfer the liability to a market participant. The Fair Value
Measurements and Disclosures topic emphasizes that fair value is a
market-based measurement, not an entity-specific measurement.
The guidance requires that assets and liabilities carried at fair
value be classified and disclosed in one of the following
categories:
●
|
Level 1: Quoted market prices in active markets for identical
assets or liabilities.
|
|
|
●
|
Level 2: Observable market-based inputs or unobservable inputs that
are corroborated by market data.
|
|
|
●
|
Level 3: Unobservable inputs that are not corroborated by market
data.
|
We have no assets or liabilities that are required to have their
fair value measured on a recurring basis at September 30, 2020
or December 31, 2019. Long-lived assets are
measured at fair value on a non-recurring basis and are subject to
fair value adjustments when there is evidence of impairment.
For short-term classes of our financial instruments, which include
cash, accounts receivable and accounts payable, and which are not
reported at fair value, the carrying amounts approximate fair value
due to their short-term nature. The fair value of the
mortgage note receivable is estimated based on the present value of
the underlying cash flows discounted at current rates. At
September 30, 2020 and December 31, 2019, the carrying value
of the mortgage note receivable approximates fair value.
(q) LIQUIDITY AND GOING CONCERN––For the nine months ended
September 30, 2020 and the year ended December 31, 2019,
the Company incurred net losses of approximately $6,262,000 and
$7,533,000, respectively. The Company has an accumulated deficit of
approximately $31,382,000 at September 30, 2020. Our recent
losses have predominantly resulted from research and development
expenses for our Trappsol® Cyclo™
product and other general operating expenses, including personnel
expenses and board advisory fees. We believe our expenses will
continue to increase as we conduct clinical trials and continue to
seek regulatory approval for the use of Trappsol® Cyclo™
in the treatment of NPC.
For the nine months ended September 30, 2020, our operations
used approximately $5,479,000 in cash. This cash was provided
primarily by cash on hand and two private placements of our
securities. At September 30, 2020, the Company had a cash
balance of approximately $2,238,000 and current liabilities
exceeded current assets by approximately $588,000. We will need
additional capital to maintain our operations, continue our
research and development programs, conduct clinical trials, seek
regulatory approvals and manufacture and market our products.
The Company has incurred losses from operations in each of the last
six years. We will need to raise additional capital through the
sale of our securities from time to time for the foreseeable future
to fund the development of our drug product candidates through
clinical development, manufacturing and commercialization. Our
ability to obtain such additional capital will likely be subject to
various factors, including our overall business performance and
market conditions. If we cannot raise the additional funds required
for our anticipated operations, we may be required to reduce the
scope of or eliminate our research and development programs, delay
our clinical trials and the ability to seek regulatory approvals,
downsize our general and administrative infrastructure, or seek
alternative measures to avoid insolvency. If we raise additional
funds through future offerings of shares of our Common Stock or
other securities, such offerings would cause dilution of current
stockholders’ percentage ownership in the Company, which could be
substantial. Future offerings also could have a material and
adverse effect on the price of our Common Stock.
Our consolidated financial statements for the three and nine months
ended September 30, 2020 and year ended December 31, 2019
were prepared on the basis of a going concern which contemplates
that we will be able to realize assets and discharge liabilities in
the normal course of business. Our ability to continue as a going
concern is dependent upon the availability of equity financing as
noted above. We will need to raise additional capital to support
our ongoing operations and continue our clinical trials. These
factors raise substantial doubt about our ability to continue as a
going concern. The financial statements do not include any
adjustments that might result from the outcome of these
uncertainties.
CYCLO THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2020
(1) SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES: (CONTINUED)
On September 29, 2020, we filed a Registration Statement on Form
S-1 with the Securities and Exchange Commission to raise capital
through the offer and sale of units consisting of shares of our
common stock and warrants to purchase additional shares of common
stock in a firm commitment underwriting to be conducted by Maxim
Capital Group, Inc. However, there can be no assurance that we will
be successful in completing the offering. The securities to be sold
in the offering may not be sold nor may offers to buy be accepted
prior to the time the Registration Statement becomes effective.
(r) USE OF ESTIMATES––The preparation of consolidated financial
statements in conformity with accounting principles generally
accepted in the United States of America requires management to
make estimates and assumptions, including regarding contingencies,
that affect the amounts reported in the consolidated financial
statements and accompanying notes.
The Company’s most significant estimate relates to inventory
obsolescence. Although management bases its estimates on historical
experience and assumptions that are believed to be reasonable under
the circumstances, actual results could significantly differ from
these estimates.
(s) RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS––In June 2016, the
FASB issued ASU 2016-13, Financial Instruments – Credit Losses
(Topic 326), which provides guidance on how an entity should
measure credit losses on financial instruments. The ASU is
effective for smaller reporting company’s for fiscal years
beginning after December 15, 2022, including interim periods with
those fiscal years. The Company does not expect this ASU to have a
material impact on its consolidated financial statements.
In December 2019, the FASB issued ASU 2019-12, Simplifying the
Accounting for Income Taxes. The amendments in ASU 2019-12
simplify the accounting for income taxes by removing certain
exceptions to the general principles and clarifying a handful of
narrow issues within the broad topic of income tax accounting. The
amendments in ASU 2019-12 are effective for years beginning after
December 15, 2020. The Company does not expect this ASU to have a
material impact on its consolidated financial statements.
(t) UNCERTAINTY––The recent outbreak of the COVID-19 coronavirus is
impacting worldwide economic activity. COVID-19 poses the risk that
we or our employees, CROs, suppliers, manufacturers and other
partners may be prevented from conducting business activities for
an indefinite period of time, including due to the spread of the
disease or shutdowns that may be requested or mandated by
governmental authorities. While it is not possible at this
time to estimate the full impact that COVID-19 could have on our
business, the continued spread of COVID-19 could disrupt our
clinical trials, supply chain and the manufacture or shipment of
our cyclodextrin products, and other related activities, which
could have a material adverse effect on our business, financial
condition and results of operations. While we have not yet
experienced any disruptions in our business or other negative
consequences relating to COVID-19, the extent to which the COVID-19
pandemic impacts our results will depend on future developments
that are highly uncertain and cannot be predicted. See also Note
9.
(2) REVENUES:
The Company operates in one business segment, which primarily
focuses on the development and commercialization of innovative
cyclodextrin-based products for the treatment of people with
serious and life threatening rare diseases and medical conditions.
However, substantially all of the Company’s revenues are derived
from the sale of cyclodextrins and related products to the
pharmaceutical, nutritional, and other industries, primarily for
use in diagnostics and specialty drugs. Currently, a small portion
of the Company’s revenues are also generated by sales of Trappsol®
Cyclo™ to South America (Brazil) for the treatment of NPC
patients.
The Company considers there to be revenue concentration risks for
regions where net product revenues exceed 10% of consolidated net
product revenues. The concentration of the Company’s net product
revenues within the regions below may have a material adverse
effect on the Company’s revenues and results of operations if sales
in the respective regions experience difficulties.
CYCLO THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2020
(2) REVENUES: (CONTINUED)
Revenues by product are summarized as follows:
|
|
Three Months Ended
September 30,
|
|
|
Nine Months Ended
September 30,
|
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
Trappsol®
Cyclo™
|
|
$ |
- |
|
|
$ |
73,500 |
|
|
$ |
30,096 |
|
|
$ |
103,596 |
|
Trappsol® HPB
|
|
|
92,384 |
|
|
|
152,784 |
|
|
|
458,934 |
|
|
|
359,530 |
|
Trappsol® Fine
Chemical
|
|
|
127,963 |
|
|
|
57,620 |
|
|
|
261,300 |
|
|
|
162,572 |
|
Aquaplex®
|
|
|
- |
|
|
|
- |
|
|
|
928 |
|
|
|
149,690 |
|
Other
|
|
|
2,115 |
|
|
|
2,010 |
|
|
|
6,532 |
|
|
|
4,447 |
|
Total revenues
|
|
$ |
222,462 |
|
|
$ |
285,914 |
|
|
$ |
757,790 |
|
|
$ |
779,835 |
|
Substantially all of our sales of Trappsol® Cyclo™
for the nine months ended September 30, 2020 and year ended
December 31, 2019 were to a single customer who exports the
drug to South America. All of our Aquaplex® sales
for the nine months ended September 30, 2020 and year ended
December 31, 2019 were to three customers.
(3) MAJOR CUSTOMERS AND SUPPLIERS:
Our revenues are derived primarily from chemical supply and
pharmaceutical companies located primarily in the United States.
For the nine months ended September 30, 2020 three major
customers accounted for 66% of total revenues. For the nine months
ended September 30, 2019, five major customers accounted for
75% of total revenues.
Substantially all inventory purchases were from three vendors in
2020 and 2019. These vendors are located primarily outside the
United States.
We have three sources for our Aquaplex®
products. There are multiple sources for our Trappsol®
products.
For the nine months ended September 30, 2020, the product mix
of our revenues consisted of 4% biopharmaceuticals, 96% basic
natural and chemically modified cyclodextrins. For the nine months
ended September 30, 2019 the product mix of our revenues
consisted of 6% biopharmaceuticals, 63% basic natural and
chemically modified cyclodextrins, and 30% cyclodextrin
complexes.
(4) MORTGAGE NOTE RECEIVABLE
On January 21, 2016, we sold our real property located in High
Springs, Florida to an unrelated party. Pursuant to the terms of
the sale, at the closing, the buyer paid $10,000 in cash, less
selling costs and settlement charges, and delivered to us a
promissory note in the principal amount of $265,000, and a mortgage
in our favor securing the buyer’s obligations under the promissory
note. The promissory note provides for monthly payments of $3,653,
including principal and interest at 4.25%, over a seven-year period
that commenced March 1, 2016, with the unpaid balance due in
February 2023.
(5) EQUITY TRANSACTIONS:
The Company expensed $5,320 and $19,380 in employee and board
member stock compensation for the three and nine months ended
September 30, 2020. The Company expensed $97,250 and $159,380
in employee and board member stock compensation for the three and
nine months ended September 30, 2019. These shares were valued
using quoted market values. The Company accrues stock compensation
expense over the period earned for employees and board members.
This expense is then trued up at the time the shares are issued
based on the trading price at the time of issuance. Stock
compensation expense for board members is included in “Board of
Directors fees and costs” on our statement of operations, and stock
compensation expense for officers and employees that are not board
members is included in “Personnel” on our statement of
operations.
CYCLO THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2020
(5) EQUITY TRANSACTIONS: (CONTINUED)
On May 31, 2019, the Company completed a private placement of its
securities to a group of accredited investors that included several
directors of the Company and members of management. Investors in
the private placement purchased a total of 29,770,000 units at a
price per unit of $0.25, each unit consisting of one share of
common stock and one warrant to purchase a share of common stock,
resulting in gross proceeds to the Company of $7,442,500, before
deducting placement agent fees and offering expenses of $452,900
resulting in net cash proceeds of $6,989,600. The warrants are
exercisable immediately upon issuance at an exercise price of $0.30
per share and expire on the 66th month
anniversary of the issuance date. The Company paid a cash fee
to its placement agent of $452,900 and issued warrants to the
placement agent and its designees to purchase an aggregate of
1,359,000 shares of common stock with the same terms as the
warrants issued to the investors. The Company filed a
registration statement with the Securities and Exchange Commission
to register the resale of the outstanding common stock and the
shares of common stock underlying the warrants and the warrants
issued to the placement agent, which was declared effective on July
12, 2019. In addition, the Company’s directors and officers entered
into Lock-Up Agreements at the closing under which they have agreed
not to sell any of their securities of the Company until the
earliest of (i) 270 days after the effective date of the
Registration Statement, (ii) 365 days after the closing, and (iii)
120 days after the listing of Company’s common stock on a national
securities exchange.
Pursuant to terms of the Placement Agency Agreement between the
Company and ThinkEquity, a division of Fordham Financial
Management, Inc. (“ThinkEquity”), entered into in connection with
Company’s May 2019 private placement (the “May Placement”), the
Company paid ThinkEquity (i) a cash fee in the amount of $29,637,
representing 8% of the gross proceeds in the Private Placement
received from investors that were first introduced to the Company
by ThinkEquity in connection with the May Placement, and (ii) a
warrant to purchase 222,282 shares of Common Stock, representing 6%
of the shares of Common Stock purchased by such investors in the
Private Placement, at an exercise price of $0.11 per share (110% of
the price per share paid by investors in the Private
Placement).
On April 24, 2020, the Company completed a private placement of
common stock to a group of accredited investors that included
several directors of the Company and members of management.
Investors in the private placement purchased a total of 20 million
shares of common stock at a price of $0.10 per share, resulting in
gross proceeds to the Company of $2,000,000.
On August 27, 2020, the Company completed a private placement of
its securities to a group of accredited investors that included
several directors of the Company and members of management.
Investors in the private placement purchased a total of 28,311,140
units at a price of $0.10 per unit, resulting in gross proceeds to
the Company of $2,831,114. Each unit consisted of one share of
common stock and a seven-year warrant to purchase one share of
common stock at an exercise price of $0.15 per share.
As of September 30, 2020, the Company had warrants outstanding
to purchase 91,854,716 shares of common stock at exercise prices of
$0.11 - $1.00 per share that expire at various dates through
2027. In addition, there are seven-year warrants outstanding
at September 30, 2020 to purchase 480,000 Units sold in our
May 2016 private placement at an exercise price of $0.25 per Unit,
164,074 Units sold in our February 2017 private placement at an
exercise price of $0.35 per Unit, and 600 Units sold in our October
2017 private placement at an exercise price of $100 per
Unit.
(6) INCOME TAXES:
The Company reported a net loss for the three and nine months ended
September 30, 2020 and 2019, respectively. The Company
increased its deferred tax asset valuation allowance rather than
recognize an income tax benefit.
(7) EQUITY INCENTIVE PLAN:
On August 29, 2019, the Company’s stockholders approved the
Company’s 2019 Omnibus Equity Incentive Plan at a special
meeting of stockholders (the “Incentive Plan”). The Incentive Plan
provides for the issuance of up to 6,843,750 shares of common stock
pursuant to the grant of shares of common stock, stock options or
other awards, to employees, officers or directors of, and
consultants to, the Company and its subsidiaries. Options granted
under the Incentive Plan may either be intended to qualify as
incentive stock options under the Internal Revenue Code of 1986, or
may be non-qualified options, and are exercisable over periods not
exceeding ten years from date of grant. As of September 30,
2020, we had awarded 450,000 shares of common stock as awards under
the Incentive Plan, with 6,393,750 shares of common stock remaining
available for future awards under the Incentive Plan.
CYCLO THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2020
(8) LEASES:
The Company adopted ASU 2016-02 “Leases (Topic 842)”
along with related clarifications and improvements effective as of
January 1, 2019, using the modified retrospective transition
method. Comparative information has not been restated and continues
to be reported under the accounting standards in effect for those
periods, as the Company has elected the package of practical
expedients permitted under the transition guidance, which among
other things, allows us to carryforward our prior lease
classifications under ASC 840, “Leases.”
Under the new guidance, right-to-use assets and lease liabilities
are recognized based on the present value of the future minimum
lease payments over the lease terms at the commencement dates. The
Company uses its incremental borrowing rates as the discount rate
for its leases, which is equal to the rate of interest the Company
would have to pay on a collateralized basis to borrow an amount
equal to the lease payments under similar terms. The incremental
borrowing rate for all existing leases as of the opening balance
sheet date was based upon the remaining terms of the leases; the
incremental borrowing rate for all new or amended leases is based
upon the lease terms. The lease terms for all the Company’s leases
include the contractually obligated period of the leases, plus any
additional periods covered by a Company options to extend the
leases that the Company is reasonably certain to exercise.
The Company has elected the package of practical expedients
permitted under the transition guidance, which among other things,
allows us to carryforward our prior lease classifications under ASC
840, “Leases.”
Adoption of Topic 842 did not have a material impact on our annual
operating results or cash flows. Operating lease expense is
recognized on a straight-line basis over the lease term and is
included in operating costs or General and administrative
expense. Variable lease payments are expensed as
incurred.
The Company determines if an arrangement is or contains a lease at
contract inception and recognizes a right-to-use asset and a lease
liability at the lease commencement date. Leases with an initial
term of 12 months or less but greater than one month are not
recorded on the balance sheet for select asset classes. The lease
liability is measured at the present value of future lease payments
as of the lease commencement date, or the opening balance sheet
date for leases existing at adoption of Topic 842. The right-to-use
asset recognized is based on the lease liability adjusted for
prepaid and deferred rent and unamortized lease
incentives.
Certain leases provide that the lease payments may be increased
annually based on the fixed rate terms or adjustable terms such as
the Consumer Price Index. Future base rent escalations
that are not contractually quantifiable as of the lease
commencement date are not included in our lease
liability.
The Company has one office lease, which is as an operating lease
and included in the right-to-use asset, current portion of lease
liability, and long-term lease liability captions on the Company’s
consolidated balance sheet.
Operating lease assets are recorded net of accumulated amortization
of $29,759 as of September 30, 2020. Lease expense for lease
payments are recognized on a straight-line basis over the lease
term. Lease expense for the nine months ended
September 30, 2020 and 2019 was $12,754 and $16,842.
CYCLO THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2020
(9) NOTE PAYABLE:
On May 4, 2020, the Company’s wholly-owned subsidiary Cyclodextrin
Technologies Development, Inc., borrowed $158,524 from BBVA USA
under the Paycheck Protection Program which was established under
the Coronavirus Aid, Relief and Economic Security Act (“CARES
Act”). The loan matures on May 4, 2022 and bears interest at a rate
of 1% per annum, payable monthly commencing on December 4, 2020.
Under the Paycheck Protection Program, the loan may be partially or
wholly forgiven if the loan is used to fund certain qualifying
expenses as described in the CARES Act. The Company intends to use
all of the loan proceeds for qualifying expenses and to apply for
forgiveness of the loan in accordance with the terms of the CARES
Act. Maturities of this note payable over the term of this note and
in the aggregate are as follows:
Year Ending December 31,
|
|
Amount
|
|
2020
|
|
$ |
7,994 |
|
2021
|
|
|
106,035 |
|
2022
|
|
|
44,495 |
|
Total
|
|
$ |
158,524 |
|
(10) SUBSEQUENT EVENTS:
The Company has evaluated subsequent events through the date these
financial statements were issued and filed with the Securities and
Exchange Commission, and has determined that except as set forth
below, there were no such events that warrant disclosure or
recognition in the financial statements.
On October 22, 2020, the Company held a special meeting of
shareholders at which the Company’s shareholders approved: (i) an
Agreement and Plan of Merger pursuant to which the Company would
merge with and into Cyclo Therapeutics, Inc., a Nevada corporation
and a wholly-owned subsidiary of the Company, resulting in the
reincorporation of the Company from the State of Florida to the
State of Nevada (the “Reincorporation”); and (ii) the adoption of
Nevada articles of incorporation which would authorize the issuance
of additional shares of common stock, and Nevada bylaws.
The Company effected the Reincorporation pursuant to the Agreement
and Plan of Merger on November 6, 2020 by filing Articles of Merger
with the Secretary of State of the State of Nevada and the
Department of State of the State of Florida.
As a result of the Reincorporation, the rights of the Company’s
shareholders previously governed by the Florida Business
Corporation Act and the Company’s Articles of Incorporation and
Bylaws in effect prior to the Reincorporation, are now governed by
Chapter 78 of the Nevada Revised Statutes and the Articles of
Incorporation and Bylaws filed and adopted by the Company under
Nevada law.
The Reincorporation resulted in a change in the state of the
Company’s incorporation from Florida to Nevada but did not result
in any change in the name, business, directors, officers,
management, fiscal year, accounting, location of the principal
executive offices, assets or liabilities of the Company.
Item 2. Management's Discussion and Analysis of Financial
Condition and Results of Operations.
The following discussion and analysis provides information to
explain our results of operations and financial
condition. You should also read our unaudited
consolidated interim financial statements and their notes included
in this Form 10-Q, and our audited consolidated financial
statements and their notes and other information included in our
Annual Report on Form 10-K for the year ended December 31,
2019. This report may contain
forward-looking statements. Forward-looking statements within this
Form 10-Q are identified by words such as “believes,”
“anticipates,” “expects,” “intends,” “may,” “will” “plans” and
other similar expressions; however, these words are not the
exclusive means of identifying such statements. In addition, any
statements that refer to expectations, projections or other
characterizations of future events or circumstances are
forward-looking statements. These forward-looking
statements are subject to significant risks, uncertainties and
other factors, which may cause actual results to differ materially
from those expressed in, or implied by, these forward-looking
statements. Except as expressly required by the federal
securities laws, we undertake no obligation to publicly update or
revise any forward-looking statements to reflect events,
circumstances or developments occurring subsequent to the filing of
this Form 10-Q with the U.S. Securities and Exchange Commission
(the “SEC”) or for any other reason and you should not place undue
reliance on these forward-looking statements. You should
carefully review and consider the various disclosures the Company
makes in this report and our other reports filed with the SEC that
attempt to advise interested parties of the risks, uncertainties
and other factors that may affect our business. All amounts
presented herein are rounded to nearest $1,000.
Overview
We are a clinical stage biotechnology company that develops
cyclodextrin-based products for the treatment of disease. We filed
a Type II Drug Master File with the U.S. Food and Drug
Administration (“FDA”) in 2014 for our lead drug candidate,
Trappsol® Cyclo™
(hydroxypropyl beta cyclodextrin) as a treatment for Niemann-Pick
Type C disease (“NPC”). NPC is a rare and fatal cholesterol
metabolism disease that impacts the brain, lungs, liver, spleen,
and other organs. In 2015, we launched an International Clinical
Program for Trappsol® Cyclo™
as a treatment for NPC. In 2016, we filed an Investigational New
Drug application (“IND”) with the FDA, which described our Phase I
clinical plans for a randomized, double blind, parallel group study
at a single clinical site in the U.S. The Phase I study evaluated
the safety of Trappsol® Cyclo™
along with markers of cholesterol metabolism and markers of NPC
during a 14-week treatment period of intravenous administration of
Trappsol® Cyclo™
every two weeks to participants 18 years of age and older. The IND
was approved by the FDA in September 2016, and in January 2017 the
FDA granted Fast Track designation to Trappsol® Cyclo™
for the treatment of NPC. Initial patient enrollment in the U.S.
Phase I study commenced in September 2017. Enrollment in this study
was completed in October 2019, and in May 2020 we announced Top
Line data showing a favorable safety and tolerability profile for
Trappsol® Cyclo™ in this study.
We have also filed Clinical Trial Applications for a Phase I/II
clinical study with several European regulatory bodies, including
those in the United Kingdom, Sweden and Italy, and in Israel, all
of which have approved our applications. The Phase I/II study is
evaluating the safety, tolerability and efficacy of
Trappsol® Cyclo™
through a range of clinical outcomes, including neurologic, and
respiratory, in addition to measurements of cholesterol metabolism
and markers of NPC. The European/Israel study is similar to the
U.S. study, providing for the administration of Trappsol® Cyclo™
intravenously to NPC patients every two weeks in a double-blind,
randomized trial but it differs in that the study period is for 48
weeks (24 doses). The first patient was dosed in this study in July
2017, and in February 2020, we announced completion of enrollment
of 12 patients in this study. In September 2020, we released
positive data from the seven patients who completed the trial,
supporting the efficacy of Trappsol® Cyclo™
in treating NPC patients.
Additionally, in February 2020 we had a face-to-face “Type C”
meeting with the FDA with respect to the initiation of a Phase III
clinical trial of Trappsol® Cyclo™ based on the clinical data
obtained to date. At that meeting, we also discussed with the FDA
submitting a New Drug Application (NDA) under Section 505(b)(1) of
the Federal Food, Drug, and Cosmetic Act for the treatment of NPC
in pediatric and adult patients with Trappsol® Cyclo™. A
similar request was submitted to the European Medicines Agency
(“EMA”) in February 2020, seeking scientific advice and protocol
assistance from the EMA for proceeding with a Phase III clinical
trial in Europe. In October 2020, the FDA notified us that we may
proceed with our proposed Phase III clinical trial of
Trappsol®
Cyclo™.
Preliminary data from our clinical studies suggest that Trappsol®
Cyclo™ releases cholesterol from cells, crosses the
blood-brain-barrier in individuals suffering from NPC, and results
in clinical improvements in NPC patients. The full significance of
these findings will be determined as part of the final analysis of
both clinical trials.
On May 17, 2010, the FDA designated Trappsol® Cyclo™ as an orphan
drug for the treatment of NPC, which would provide us with the
exclusive right to sell Trappsol® Cyclo™ for the treatment of NPC
for seven years following FDA drug approval. In April 2015, we also
obtained Orphan Drug Designation for Trappsol® Cyclo™ in Europe,
which will provide us with 10 years of market exclusivity following
regulatory approval, which period will be extended to 12 years upon
acceptance by the EMA’s Pediatric Committee of our pediatric
investigation plan (PIP) demonstrating that Trappsol® Cyclo™
addresses the pediatric population. On January 12, 2017, we
received Fast Track Designation from the FDA, and on December 1,
2017, the FDA designated NPC a Rare Pediatric Disease and issued us
a Priority Review Voucher with respect to the treatment of NPC with
Trappsol® Cyclo™.
We are also exploring the use of cyclodextrins in the treatment of
Alzheimer’s disease. In January 2018, the FDA authorized a single
patient IND expanded access program using Trappsol® Cyclo™ for the
treatment of this disease. After 18 months of treatment in this
geriatric patient with late-onset disease, the disease was
stabilized and the drug was well tolerated. The patient also
exhibited signs of improvement with less volatility and shorter
latency in word-finding. In October 2019, we entered into an
agreement with Worldwide Clinical Trials, a Contract Research
Organization, to conduct a clinical trial to evaluate the safety
and efficacy of Trappsol® Cyclo™ for the treatment of Alzheimer’s
disease. We prepared a synopsis for an early stage protocol using
Trappsol® Cyclo™ intravenously to treat Alzheimer’s Disease, and we
plan to present this synopsis to the FDA in early 2021.
We filed a provisional patent application for the treatment of
Alzheimer’s disease with cyclodextrins with the U.S. Patent and
Trademark Office in October 2018, which was amended based on
additional clinical data in August 2019; and we filed a similar
international patent application in October 2019 under the Patent
Cooperation Treaty.
We also continue to operate our legacy fine chemical business,
consisting of the sale of cyclodextrins and related products to the
pharmaceutical, nutritional, and other industries, primarily for
use in diagnostics and specialty drugs. However, our core business
has transitioned to a biotechnology company primarily focused on
the development of cyclodextrin-based biopharmaceuticals for the
treatment of disease from a business that had been primarily
reselling basic cyclodextrin products.
Liquidity and Capital Resources
Our cash decreased to approximately $2,238,000 as of
September 30, 2020, compared to $2,784,000 as of
December 31, 2019. Our current assets less current liabilities
were $(588,000) as of September 30, 2020, compared to $817,000
at December 31, 2019. Cash used in operations was $5,479,000
for the nine months ended September 30, 2020, compared to
$4,368,000 for the same period in 2019. The increase in cash used
in operations is due primarily to our net loss and increasing
expenses for our drug development and expansion strategy, which we
intend to continue funding with the capital we raise.
We raised $2,000,000 in April 2020, and an additional $2,831,000 in
August 2020, from the sale of securities in two private placements.
We plan to use the proceeds of the sale of our securities primarily
for the development of our Trappsol® Cyclo™
orphan drug product, including in connection with our continuing
International Clinical Program and U.S. clinical trials, and other
general corporate purposes. We also borrowed $158,524
under the Paycheck Protection Program in May 2020, and plan to use
the loan proceeds for qualifying expenses and to apply for
forgiveness of the loan in accordance with the terms of the CARES
Act. While we currently believe our use of the loan proceeds met or
will meet the conditions for forgiveness of the loan, there can be
no assurance in that regard.
On September 29, 2020, we filed a Registration Statement on Form
S-1 with the Securities and Exchange Commission to raise capital
through the offer and sale of units consisting of shares of our
common stock and warrants to purchase additional shares of common
stock in a firm commitment underwriting to be conducted by Maxim
Capital Group, Inc. However, there can be no assurance that we will
be successful in completing the offering. The securities to be sold
in the offering may not be sold nor may offers to buy be accepted
prior to the time the Registration Statement becomes effective.
The Company has continued to realize losses from operations. We
will need to raise additional capital to support our ongoing
operations and continue our clinical trials. While we presently
lack sufficient cash to meet our anticipated operating costs and
capital expenditure requirements through July 2021, we expect to
continue to raise additional capital through the sale of our
securities from time to time for the foreseeable future to fund the
development of our drug product candidates through clinical
development, manufacturing and commercialization. Our ability to
obtain such additional capital will likely be subject to various
factors, including our overall business performance and market
conditions. There can be no guarantee that the Company will be
successful in its ability to raise capital to fund future
operational and development initiatives. Our need for additional
capital as described above raises substantial doubt about our
ability to continue as a going concern. The financial statements do
not include any adjustments that might result from the outcome of
these uncertainties.
Our consolidated financial statements for the three and nine months
ended September 30, 2020 and year ended December 31, 2019 were
prepared on the basis of a going concern which contemplates that we
will be able to realize assets and discharge liabilities in the
normal course of business. We have incurred losses from operations
in each of our last six fiscal years. Our ability to continue as a
going concern is dependent upon the availability of equity
financing as noted above.
At December 31, 2019, we had approximately $18,335,000 in net state
and federal operating loss carryforwards expiring from 2020 through
2037, including $9,692,000 that will not expire, that can be used
to offset our current and future taxable net income and reduce our
income tax liabilities. We have provided a 100% valuation allowance
on our deferred tax asset based on our expected future expenses
related to our clinical trials and other development
initiatives.
We have no off-balance sheet arrangements at September 30,
2020.
Results of Operations - Three and Nine
Months Ended September 30, 2020
Compared to Three and Nine Months
Ended September 30, 2019
We reported net losses of $(1,436,000) and $(6,262,000) for the
three and nine months ended September 30, 2020, respectively,
compared to net losses of $(1,625,000) and $(4,898,000) for the
three and nine months ended September 30, 2019, respectively.
Total revenues for the three month period ended September 30,
2020 decreased 23% to $222,000 compared to $286,000 for the same
period in 2019. Total revenues for the nine month period ended
September 30, 2020 decreased 3% to $758,000 compared to
$780,000 for the same period in 2019. Our change in the mix of our
product sales for the three and nine months ended
September 30, 2020 and 2019 is as follows:
Trappsol® Cyclo
There were no sales of Trappsol® Cyclo™ for the three month period
ended September 30, 2020 and $74,000 for the three month period
ended September 30, 2019. Our sales of Trappsol® Cyclo™ decreased
by 71% for the nine month period ended September 30, 2020, to
$30,000 from $104,000 for the nine month period ended September 30,
2019. Substantially all of our sales of Trappsol® Cyclo™
for the nine months ended September 30, 2020 and 2019 were to
a particular customer who exports the drug to South America. Our
annual 2019 sales to this customer were $104,000 (100% of total
2019 sales of Trappsol® Cyclo™). This product is
designated as an orphan drug; the population of patients who use
the product on a compassionate basis is small.
Trappsol® HPB
Our sales of Trappsol® HPB decreased by 40% for the three month
period ended September 30, 2020, to $92,000 from $153,000 for
the three months ended September 30, 2019. Our sales of
Trappsol® HPB increased by 28% for the nine month period ended
September 30, 2020, to $459,000 from $360,000 for the nine
months ended September 30, 2019.
Trappsol® other products
Our sales of other Trappsol® products increased for the three month
period ended September 30, 2020, to $128,000 from $58,000 for
the three months ended September 30, 2019. Our sales of other
Trappsol® products increased for the nine month period ended
September 30, 2020, to $261,000 from $163,000 for the nine
months ended September 30, 2019.
Aquaplex®
There were no sales of Aquaplex® for the three month periods ended
September 30, 2020 and 2019. Our sales of Aquaplex® were $1,000 for
the nine month period ended September 30, 2020 compared to $150,000
for the nine month period ended September 30, 2019.
The largest customers for our legacy fine chemical business
continue to follow historical product ordering trends by placing
periodic large orders that represent a significant share of our
annual sales volume. During the nine months ended
September 30, 2020, our three largest customers accounted for
66% of our sales; the largest accounted for 31% of sales. During
the nine months ended September 30, 2019, our five largest
customers accounted for 75% of our sales; the largest accounted for
18% of sales. Historically, our usual smaller sales of HPB occur
more frequently throughout the year compared to our large sales
that we receive periodically. The timing of when we receive and are
able to complete these two kinds of sales has a significant effect
on our quarterly revenues and operating results and makes period to
period comparisons difficult.
Our cost of products sold (excluding any allocation of direct and
indirect overhead and handling costs) for the nine month period
ended September 30, 2020 decreased 19% to $51,000 from $63,000
for the same period in 2019. Our cost of products sold (excluding
any allocation of direct and indirect overhead and handling costs)
for the three month period ended September 30, 2020 decreased 54%
to $12,000 from $26,000 for the same period in 2019. Our cost of
products sold (excluding any allocation of direct and indirect
overhead and handling costs) as a percentage of sales was 7% for
the nine months ended September 30, 2020 and 9% for the nine
months ended September 30, 2019. Historically, the timing and
product mix of sales to our large customers has had a significant
effect on our sales, cost of products sold (excluding any
allocation of direct and indirect overhead and handling costs) and
the related margin. We did not experience any significant increases
in material costs during 2019, or the first nine months of
2020.
Our gross margins may not be comparable to those of other entities,
since some entities include all the costs related to their
distribution network in cost of goods sold. Our cost of goods sold
includes only the cost of products sold and does not include any
allocation of inbound or outbound freight charges, indirect
overhead expenses, warehouse and distribution expenses, or
depreciation expense. Our employees provide receiving, inspection,
warehousing and shipping operations for us. The cost of our
employees is included in personnel expense. Our other costs of
warehousing and shipping functions are included in office and other
expense.
As we buy inventory from foreign suppliers, the change in the value
of the U.S. dollar in relation to the Euro and Yuan may from time
to time have an effect on our cost of inventory. Our main supplier
of specialty cyclodextrins and complexes, Cyclodextrin Research
& Development Laboratory, is located in Hungary and its prices
are set in Euros. The cost of our bulk inventory often changes due
to fluctuations in the U.S. dollar. There were no purchases of
inventory from Hungary during the nine months ended June 30, 2020.
The cost of shipping from outside the U.S. also has a significant
effect on our inventory acquisition costs. In addition,
unpredictable changes in United States import tariffs also impacts
our costs for raw materials. When we experience short-term
increases in currency fluctuation, tariff increases, or supplier
price increases, we are often not able to raise our prices
sufficiently to maintain our historical margins. Therefore, our
margins on these sales may decline.
Personnel expenses decreased by 19%, to $425,000 for the three
months ended September 30, 2020 from $521,000 for the three
months ended September 30, 2019. Personnel expenses increased
by 7%, to $1,328,000 for the nine months ended September 30,
2020 from $1,242,000 for the nine months ended September 30,
2019. The increase in personnel expense is due to additional
personnel added during the middle of 2019. We expect to maintain
our level of employees and related costs in the near term.
Research and development expenses increased 15% to $1,087,000 for
the three months ended September 30, 2020, from $942,000 for
the three months ended September 30, 2019. Research and
development expenses increased 58% to $4,860,000 for the nine
months ended September 30, 2020, from $3,071,000 for the nine
months ended September 30, 2019. Research and development
expenses as a percentage of our total operating expenses increased
to 69% for the nine months ended September 30, 2020 from 54% for
the nine months ended September 30, 2019. The increase in research
and development expense is due to increased activity in our
International Clinical Program and U.S. clinical trials. We expect
future research and development costs to further increase as we
commence our Phase III clinical trial of Trappsol® Cyclo™
and continue to seek regulatory approval for the use of Trappsol®
Cyclo™ in the treatment of NPC and Alzheimer’s disease.
Professional fees decreased 53% to $72,000 for the three months
ended September 30, 2020, compared to $152,000 for the three
months ended September 30, 2019. Professional fees decreased
29% to $435,000 for the nine months ended September 30, 2020,
compared to $613,000 for the nine months ended September 30,
2019. Professional fees may increase in the future due to new
initiatives in raising capital and the continuation of product
development.
Office and other expenses decreased 80% to $48,000 for the three
months ended September 30, 2020, compared to $234,000 for the
three months ended September 30, 2019. Office and other
expenses decreased 48% to $306,000 for the nine months ended
September 30, 2020, compared to $584,000 for the nine months ended
September 30, 2019. Office and other expenses include costs
for travel to, and participation in, industry conferences and
similar events, which vary from period to period.
Board of Directors fees and costs decreased to $10,000 for the
three months ended September 30, 2020, compared to $37,000 for the
three months ended September 30, 2019. Board of Directors fees
and costs decreased to $38,000 for the nine months ended
September 30, 2020, compared to $102,000 for the nine months
ended September 30, 2019. Board of Directors fees and costs
include fees (generally in the form of stock compensation) paid to
our non-employee directors and scientific advisory board members,
reimbursement of expenses of our board members, and related
expenses. The reduction in Board of Directors fees and costs for
the three and nine months ended September 30, 2020 compared to the
same periods in the prior year was due to a decrease in the market
price of the Company’s common stock.
We increased our valuation allowance to offset the increase in our
deferred tax asset from our net operating loss and did not
recognize an income benefit or provision for the nine months ended
September 30, 2020, and 2019, respectively.
Item 3. Quantitative and Qualitative Disclosures
About Market Risk.
Not applicable.
Item 4. Controls and Procedures.
a. Evaluation of Disclosure Controls and Procedures.
Our management, with the participation of our principal executive
and principal financial officer, has evaluated the effectiveness of
our disclosure controls and procedures (as such term is defined in
Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of
1934, as amended (the "Exchange Act")) as of the end of the period
covered by this report (the "Evaluation Date"). Based on such
evaluation, our principal executive officer and principal financial
officer have concluded that our disclosure controls and procedures
were effective as of September 30, 2020.
b. Changes in Internal Control.
We made no changes in our internal control over financial reporting
(as defined in Rules 13a-15(f)) and 15d-15(f) under the Exchange
Act) identified in connection with the evaluation of our internal
controls that occurred during our last fiscal quarter that has
materially affected, or which is reasonably likely to materially
affect, our internal controls over financial reporting.
PART II. OTHER INFORMATION
Item 1A. Risk Factors.
We have identified no additional risk factors other than those
included in our Registration Statement on Form S-1 that we filed
with the Securities and Exchange Commission on September 29,
2020. Readers are urged to carefully review our risk
factors because they may cause our results to differ from the
"forward-looking" statements made in this report. Additional
risks not presently known to us or other factors not perceived by
us to present significant risks to our business at this time also
may impair our business, financial condition and results of
operations. We do not undertake to update any of the
"forward-looking" statements or to announce the results of any
revisions to these "forward-looking" statements except as required
by law.
Item 6. Exhibits.
101.INS
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XBRL Instance Document
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101.SCH
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XBRL Taxonomy Extension Schema Document
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101.CAL
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XBRL Taxonomy Extension Calculation Linkbase Document
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101.DEF
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XBRL Taxonomy Extension Definition Linkbase Document
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101.LAB
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XBRL Taxonomy Extension Label Linkbase Document
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101.PRE
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XBRL Taxonomy Extension Presentation Linkbase Document
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SIGNATURES
Pursuant to the requirements of the Exchange Act, the registrant
has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
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CYCLO THERAPEUTICS, INC.
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Date: November 12, 2020
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By:
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/s/ N. Scott Fine
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N. Scott Fine
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Chief Executive Officer
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(principal executive officer)
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Date: November 12, 2020
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By:
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/s/ Joshua M. Fine
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Joshua M. Fine
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Chief Financial Officer
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(principal financial and accounting
officer)
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Cyclo Therapeutics (QB) (USOTC:CTDH)
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