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, 2017
March 31, 2021

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

 

CTD HOLDINGS,CYCLO THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

FloridaNevada

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

Common Stock, par value $.0001 per share

CYTH

The Nasdaq Stock Market LLC

Warrants to purchase Common Stock

CYTHW

The Nasdaq Stock Market LLC

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐   No ☒ 

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐   No ☒ 

 

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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post 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 9, 2017,May 3, 2021 the Company had outstanding 73,105,8346,358,661 shares of its common stock.

 


 

CYCLO THERAPEUTICS, INC.

FORM 10-Q 

TABLE OF CONTENTS

 

Description

Page

PART I

FINANCIAL INFORMATION

1

Item 1.

Financial Statements.

1

Consolidated BalanceBalance Sheets as of September 30, 2017March 31, 2021 (Unaudited) and December 31, 2016.2020.

1

Consolidated Statements of Operations (Unaudited) for the Three and Nine Months Ended September 30, 2017March 31, 2021 and 2016.2020.

2

Consolidated Statement of Stockholders’ Equity (Unaudited) for the Three Months Ended March 31, 2021

3

Consolidated Statement of Stockholders’ Equity (Deficit) (Unaudited) for the Three Months Ended March 31, 2020

4

Consolidated Statements of Cash Flows (Unaudited) for the NineThree Months Ended September 30, 2017March 31, 2021 and 2016.2020.

35

Notes to Consolidated Financial Statements.

46

Item 2.

Management’sManagement’s Discussion and Analysis of Financial Condition and Results of Operations.

813

Item 3.

Quantitative and Qualitative Disclosures about Market Risk.

1217

Item 4.

Controls and Procedures.

1217

PART II

OTHER INFORMATION

1318

Item 1A.

Risk Factors.

1318

Item 6.

Exhibits.

1318

SIGNATURES

14

 


 

PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements.

 

CTD HOLDINGS,CYCLO THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

 

 

September 30,

2017

  

December 31,

2016

  

March 31,

2021

  

December 31,

2020

 
 

(Unaudited)

      

(Unaudited)

     

ASSETS

ASSETS

 

ASSETS

 

CURRENT ASSETS

                

Cash and cash equivalents

 $1,342,642  $960,197  $15,506,718  $12,846,113 

Accounts receivable

  94,017   89,667   171,864   71,017 

Inventory

  474,010   497,397 

Inventory, net

  257,834   237,909 

Current portion of mortgage note receivable

  34,393   34,393   48,304   40,772 

Other

  20,210   53,879 

Prepaid insurance and services

  219,752   126,474 

Prepaid clinical expenses

  1,816,633   727,952 

Total current assets

  1,965,272   1,635,533   18,021,105   14,050,237 
                

FURNITURE AND EQUIPMENT, NET

  27,225   29,984   50,360   53,910 
                

Mortgage note receivable, less current portion

  177,359   203,028 

RIGHT-TO-USE LEASE ASSET, NET

  30,862   34,011 
        

MORTGAGE NOTE RECEIVABLE, LESS CURRENT PORTION

  38,942   49,806 
                

TOTAL ASSETS

 $2,169,856  $1,868,545  $18,141,269  $14,187,964 
                

LIABILITIES AND STOCKHOLDERS’ EQUITY

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

LIABILITIES AND STOCKHOLDERS EQUITY

 
                

CURRENT LIABILITIES

                

Current portion of lease liability

 $18,325  $17,483 

Current portion of note payable

  60,142   114,029 

Accounts payable and accrued expenses

 $545,171  $342,542   3,628,293   3,541,041 

Advance – private placement

  585,000   - 

Total current liabilities

  1,130,171   342,542   3,706,760   3,672,553 
                

LONG-TERM LEASE LIABILITY

        

Long-term lease liability, less current portion

  14,560   18,434 

Long-term note payable, less current portion

  98,382   44,495 

Total long-term liabilities

  112,942   62,929 
        

STOCKHOLDERS' EQUITY

                

Common stock, par value $.0001 per share, 100,000,000 shares authorized, 72,999,361 and 66,952,529 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively

  7,299   6,695 

Preferred stock, par value $.0001 per share, 5,000,000 shares authorized, no shares issued or outstanding

  -   - 

Common stock, par value $.0001 per share, 10,000,000 shares authorized, 6,357,596 and 4,770,761 shares issued and outstanding, at March 31, 2021 and December 31, 2020, respectively

  635   477 

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

  -   - 

Additional paid-in capital

  12,980,986   11,018,915   52,419,383   44,513,841 

Accumulated deficit

  (11,948,600

)

  (9,499,607

)

  (38,098,451

)

  (34,061,836

)

Total stockholders' equity

  1,039,685   1,526,003   14,321,567   10,452,482 
                

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

 $2,169,856  $1,868,545  $18,141,269  $14,187,964 

 

See accompanying Notes to Consolidated Financial Statements.

 


1

 

CTD HOLDINGS,

CYCLO THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

  

Three Months Ended

 
  

March 31,

 
  

2021

  

2020

 
         

REVENUES

        

Product sales

 $358,133  $325,734 
         

EXPENSES

        

Personnel

  559,324   469,705 

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

  34,596   26,433 

Research and development

  3,258,115   2,059,606 

Repairs and maintenance

  1,666   1,802 

Professional fees

  222,871   219,536 

Office and other

  313,774   178,362 

Board of Director fees and costs

  -   7,349 

Depreciation

  3,550   3,118 

Freight and shipping

  1,513   1,863 

Total operating expenses

  4,395,409   2,967,774 
         

LOSS FROM OPERATIONS

  (4,037,276

)

  (2,642,040

)

         

OTHER INCOME

        

Investment and other income

  661   8,048 
         

LOSS BEFORE INCOME TAXES

  (4,036,615

)

  (2,633,992

)

         

PROVISION FOR INCOME TAXES

  -   - 
         

NET LOSS

 $(4,036,615

)

 $(2,633,992

)

         

BASIC AND DILUTED NET LOSS PER COMMON SHARE

 $(.76

)

 $(2.17

)

         

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING

  5,333,806   1,215,650 
(Unaudited)
  

Three Months Ended

  

Nine Months Ended

 
  

September 30,

  

September 30,

 
  

2017

  

2016

  

2017

  

2016

 
                 

REVENUES

                

Product sales

 $241,147  $278,196  $1,069,289  $975,267 
                 

EXPENSES

                

Personnel

  268,684   327,858   908,049   1,010,296 

Cost of products sold (exclusive of depreciation, shown separately below)

  19,660   30,893   118,056   123,896 

Research and development

  338,723   311,351   1,509,352   1,254,900 

Repairs and maintenance

  1,203   3,334   5,198   19,073 

Professional fees

  116,004   175,616   542,007   454,646 

Office and other

  111,713   171,425   338,250   478,740 

Board of Director fees and costs

  18,010   53,195   94,763   99,576 

Depreciation

  2,413   3,789   6,873   92,146 

Freight and shipping

  1,635   1,465   6,246   5,257 

Loss (gain) on disposal of property and equipment

  -   -   (1,261)  4,489 

Impairment on assets held for sale

  -   810,000   -   810,000 
   878,045   1,888,926   3,527,533   4,353,019 
                 

LOSS FROM OPERATIONS

  (636,898)  (1,610,730

)

  (2,458,244)  (3,377,752

)

                 

OTHER INCOME (EXPENSE)

                

Investment and other income

  3,149   2,766   9,251   7,609 

Interest expense

  -   (6,969

)

  -   (21,722

)

   3,149   (4,203

)

  9,251   (14,113

)

                 

LOSS BEFORE INCOME TAXES

  (633,749)  (1,614,933

)

  (2,448,993)  (3,391,865

)

                 

Provision for income taxes

  -   -   -   - 
                 

NET LOSS

 $(633,749

)

 $(1,614,933

)

 $(2,448,993) $(3,391,865

)

                 

BASIC AND FULLY DILUTED NET LOSS PER COMMON SHARE

 $(.01) $(.02

)

 $(.03) $(.05

)

                 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING

  72,966,028   66,889,822   71,721,264   62,121,283 

 

See Accompanying Notes to Consolidated Financial Statements.

 


2

 

CYCLO THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY

FOR THE THREE MONTHS ENDED MARCH 31, 2021

(Unaudited)

  

Common Stock

  

Additional

      

Total

 
  

Shares

  

Par
Value

  

Paid-In
Capital

  

Accumulated
Deficit

  

Stockholders

Equity

 
             ��       

Balance, December 31, 2020

  4,770,761  $477  $44,513,841  $(34,061,836

)

 $10,452,482 
                     

Stock issued to employees

  53,938   5   271,303   -   271,308 
                     

Stock issued to nonemployees

  10,000   1   50,299   -   50,300 
                     

Exercise of warrants

  1,522,897   152   7,583,940   -   7,584,092 
                     

Net loss

  -   -   -   (4,036,615

)

  (4,036,615

)

                     

Balance, March 31, 2021

  6,357,596  $635  $52,419,383  $(38,098,451

)

 $14,321,567 

See accompanying Notes to Consolidated Financial Statements.

3

CYCLO THERAPEUTICS, INC.

CTD HOLDINGS,CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIT)

FOR THE THREE MONTHS ENDED MARCH 31, 2020

(Unaudited)

  

Common Stock

  

Additional

      

Total

 
  

Shares

  

Par
Value

  

Paid-In
Capital

  

Accumulated
Deficit

  

Stockholders

Equity (Deficit)

 
                     

Balance, December 31, 2019

  1,215,650  $122  $26,056,093  $(25,120,233

)

 $935,982 
                     

Net loss

  -   -   -   (2,633,992

)

  (2,633,992

)

                     

Balance, March 31, 2020

  1,215,650  $122  $26,056,093  $(27,754,225

)

 $(1,698,010

)

See accompanying Notes to Consolidated Financial Statements.

4

CYCLO THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

  

Three Months Ended

 
�� 

March 31,

 
  

2021

  

2020

 

CASH FLOWS FROM OPERATING ACTIVITIES

        

Net loss

 $(4,036,615) $(2,633,992

)

Adjustments to reconcile net loss to net cash used in operating activities:

        

Depreciation

  3,550   3,118 

Accrued stock compensation to employees

  -   2,470 

Accrued stock compensation to non-employees

  -   4,750 

Issuance of stock based compensation

  50,300   - 

Increase or decrease in:

        

Accounts receivable

  (100,847

)

  (25,394

)

Inventory

  (19,925)  13,859 

Prepaid clinical expenses

  (1,088,681)  59,096 

Prepaid insurance and services

  (93,278

)

  (37,013

)

Other current assets

  -   (9,615

)

Other

  117   226 

Accounts payable and accrued expenses

  358,560   803,630 

Total adjustments

  (890,204)  824,742 
         

NET CASH USED IN OPERATING ACTIVITIES

  (4,926,819

)

  (1,809,250

)

         

CASH FLOWS FROM INVESTING ACTIVITIES

        

Purchases of furniture and equipment

  -   (50,627

)

Proceeds from mortgage note receivable

  3,332   9,615 
         

NET CASH PROVIDED BY (USED IN) INVESTING ACTIVITIES

  3,332   (41,012

)

         

CASH FLOWS FROM FINANCING ACTIVITIES

        

Net proceeds from exercise of warrants

  7,584,092   - 
         

NET CASH PROVIDED BY FINANCING ACTIVITIES

  7,584,092   - 
         

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

  2,660,605   (1,850,262

)

         

CASH AND CASH EQUIVALENTS, beginning of period

  12,846,113   2,783,719 
         

CASH AND CASH EQUIVALENTS, end of period

 $15,506,718  $933,457 
         

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION

        

Cash paid for interest

 $-  $- 

Cash paid for income taxes

 $-  $- 
(Unaudited)
  

Nine Months Ended

 
  

September 30,

 
  

2017

  

2016

 

CASH FLOWS FROM OPERATING ACTIVITIES

        

Net loss

 $(2,448,993) $(3,391,865

)

         

Adjustments to reconcile net loss to net cash used in operating activities:

        

Depreciation

  6,873   92,146 

Loss (gain) on sale of property and equipment

  (1,261)  4,489 

Impairment on assets held for sale

  -   810,000 

Accrued stock compensation to employees

  76,030   57,114 

Accrued stock compensation to non-employees

  31,110   44,106 

Increase or decrease in:

        

Accounts receivable

  (4,350)  (68,598

)

Inventory

  23,387   19,758 

Other current assets

  33,669   13,173 

Accounts payable and accrued expenses

  207,109   33,120 

Total adjustments

  372,567   1,005,308 

NET CASH USED IN OPERATING ACTIVITIES

  (2,076,426)  (2,386,557

)

         

CASH FLOWS FROM INVESTING ACTIVITIES

        

Purchase of equipment and building improvements

  (7,503)  (9,343

)

Proceeds from mortgage note receivable

  25,669   19,203 

Proceeds from sale of equipment

  4,650   5,510 

NET CASH PROVIDED BY INVESTING ACTIVITIES

  22,816   15,370 
         

CASH FLOWS FROM FINANCING ACTIVITIES

        

Advance – private placement

  585,000   - 

Net proceeds from sale of common stock and warrants

  1,851,055   1,880,000 

Principal payments on notes payable

  -   (46,704

)

Payments on line of credit

  -   (34,296

)

NET CASH PROVIDED BY FINANCING ACTIVITIES

  2,436,055   1,799,000 
         

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

  382,445   (572,187

)

         

CASH AND CASH EQUIVALENTS, beginning of period

  960,197   1,842,233 
         

CASH AND CASH EQUIVALENTS, end of period

 $1,342,642  $1,270,046 
         

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION

        

Cash paid for interest

 $-  $21,722 
         

Cash paid for income taxes

 $-  $- 

SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING AND FINANCING

        

Exchange of property held for sale for a mortgage note receivable

 $-  $265,000 

 

See Accompanying Notes to Consolidated Financial Statements.

 


5

 

CTD HOLDINGS,CYCLO THERAPEUTICS, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2017(Unaudited)

 

The information presented herein as of September 30, 2017March 31, 2021 and for the three and nine months ended September 30, 2017March 31, 2021 and 20162020 is unaudited.

 

(1) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:

 

The following is a summary of the more significant accounting policies of CTD Holdings, Inc. and subsidiaries (“we”,Cyclo Therapeutics, Inc. (the “Company,” “we,” “our”, or “us” or the “Company”) that affect the accompanying consolidated financial statements.statements:

 

(a) ORGANIZATION AND OPERATIONSOPERATIONS––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 on November 6, 2020, we reincorporated from the State of Florida to the State of Nevada.

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”) in 2014 for our lead drug candidate, Trappsol® Cyclo™ as a treatment for Niemann-Pick Type C disease (“NPC”),. NPC is a rare and fatal cholesterol metabolism disease that impacts the brain, lung,lungs, liver, spleen, and other organs. The FDA recently approved ourIn 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)(“IND”) with the FDA, which describesdescribed our Phase I clinical plans for a randomized, double blind, parallel group study at a single clinical site in the U.S. forThe 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 1I 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. In October 2020 we received a “Study May Proceed” notification from the FDA with respect to the proposed Phase III clinical trial.

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 Israel 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 first patient was dosed in our Europeanthis study in July 2017.2017, 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.

In January 2018, the FDA authorized a single patient IND expanded access program using 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 that was presented to the FDA in January of 2021. We received feedback from the FDA on this synopsis in April 2021 and have incorporated the feedback into our development strategy for the filing of an IND for a Phase II program.  We intend to submit this IND to the FDA in the second half of 2021.

 

We also sellcontinue 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 with continuing growth in research and new product development.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 whichthat had been primarily reselling basic cyclodextrin products.

 

(b) BASIS OF PRESENTATIONPRESENTATION––The accompanying consolidated financial statements include the Company and its wholly owned subsidiaries. All significant intercompany accounts and transactions have been preparedeliminated in accordance with generally accepted accounting principles forconsolidation. The interim consolidated financial information and withstatements of the instructions toCompany included in this Quarterly Report on Form 10-Q, and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements.including these notes, are unaudited. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the consolidated financial statements have been included.

Operating results 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 three and nine monthfiscal year ended December 31, 2020. The consolidated financial statements should be read in conjunction with that Annual Report on Form 10-K. Results for the interim periods ended September 30, 2017presented are not necessarily indicative of the results that maymight be expected for the year ending December 31, 2017. For further information, refer to the consolidated financial statements and footnotes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the Securities and Exchange Commission on March 17, 2017.entire fiscal year.

6

CYCLO THERAPEUTICS, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

(1) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:  (CONTINUED)

 

(c) CASH AND CASH EQUIVALENTSEQUIVALENTS––Cash and cash equivalents consist of cash and any highly liquid investments with an original purchased maturity of three months or less.

 

(d) ACCOUNTS RECEIVABLERECEIVABLE––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 ourthe 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, we have concluded that losses on balances outstandingan allowance for doubtful accounts was not deemed necessary at September 30, 2017March 31, 2021 and December 31, 2016 will be immaterial.2020.

 

(e) INVENTORY AND COST OF PRODUCTS SOLDSOLD––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. The Company records a specific reserve for inventory items that are determined to be obsolete. The reserve for obsolete inventory was $52,922 at March 31, 2021 and December 31, 2020, 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. Cost of products sold includes the acquisition cost of the products sold and does not include any allocation of inbound or outbound freight charges, indirect overhead expenses, warehouse and distribution expenses, or depreciation and amortization expense.


CTD HOLDINGS, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2017

 

(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. Prepaid clinical expenses represent valid future economic benefits based on our contracts with our vendors, and will be realized in the ordinary course of business.

(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.cost, less accumulated depreciation. Depreciation on furniture and equipment 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. 

7

CYCLO THERAPEUTICS, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

(g)(1) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:  (CONTINUED)

(i) REVENUE RECOGNITIONRECOGNITION–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 revenuerevenues following the five step model prescribed under Accounting Standard Update (“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. we sell our products to the end user or wholesale distributors. In other countries, we sell our products primarily to wholesale distributors and other third-party distribution partners. These customers subsequently resell our products to health care providers and patients.

Revenues from product sales and royaltiesare recognized when the following four revenue recognition criteria are met: persuasive evidencecustomer obtains control of an arrangement exists,our product, which occurs at a point in time, typically upon delivery has occurredto the customer. 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 servicesless 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 been rendered,identified one performance obligation in our contracts with customers which is the sellingdelivery of product to our customers.  The transaction price is fixedrecognized 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 determinable,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 collectability is reasonably assured. Productreturns. These reserves are based on estimates of the amounts earned or to be claimed on the related sales and shippingare 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 netrecognized 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 any discounts or return allowances, are recorded when the products are shippedadjustment.

For additional information on our revenues, please read Note 2, Revenues, to these consolidated financial statements.

(j) SHIPPING AND HANDLING FEES––Shipping and title passes to customers. Saleshandling fees, if billed to customers, are made pursuant to a sales contract that provides for transfer of both titleincluded in product sales. Shipping and risk of loss upon our delivery to the carrier. Return allowances, which reduce product revenue, have been historically infrequent,handling costs associated with inbound and outbound freight are recorded when they become known. Amounts receivedexpensed as incurred and included in advance are deferredfreight and recognized as revenue when all four revenue recognition criteria have been met. There is no deferred revenue at September 30, 2017 and December 31, 2016.shipping expense.

 

(h)(k) ADVERTISING––Advertising costs are charged to operations when incurred. We incur minimal advertising expenses.

(l) RESEARCH AND DEVELOPMENT COSTSCOSTS––Research and development costs are expensed as incurred.

 

(i)(m) INCOME TAXESTAXES––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.

8

CYCLO THERAPEUTICS, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

(j)(1) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:  (CONTINUED)

(n) NET LOSS PER COMMON SHARESHARE––Basic and fully diluted net loss per common share is computed using a simple weighted average of common shares outstanding during the periods presented;presented, as outstanding warrants to purchase 15,085,787 and 9,057,5002,130,268 common shares were antidilutive for the three and nine months ended September 30, 2017March 31, 2021 and 2016, respectively, and have been excluded from the calculation of loss per common share.year ended December 31, 2020.

 

(k)(o) STOCK BASED COMPENSATIONCOMPENSATION––The Company periodically awards stock to employees, directors, and consultants. AnIn 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.

 

(l) CONCENTRATIONS OF CREDIT RISK(p) FAIR VALUE MEASUREMENTS AND DISCLOSURES––Significant concentrationsThe Fair Value Measurements and Disclosures topic of credit risk for all financial instruments owned by the Company are as follows: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.

 

(i) DEMAND AND CERTIFICATE OF DEPOSITS––We maintain bank accountsThe guidance requires that assets and liabilities carried at fair value be classified and disclosed in Federal credit unions and other financial institutions, which are insured up toone of the Federal Deposit Insurance Corporation limits. The bank accounts may exceed Federally insured levels; however, we have not experienced any losses in such accounts.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.

(ii) ACCOUNTS RECEIVABLE––Our accounts receivable consist of amounts due primarily from chemical supply and pharmaceutical companies located primarily in the United States. Three customers accounted for 87% of the accounts receivable balance at September 30, 2017. Two customers accounted for 81% of the accounts receivable balance at December 31, 2016.

We have no policy requiring collateralassets or other securityliabilities that are required to support our accounts receivable.


CTD HOLDINGS, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2017have their fair value measured on a recurring basis at March 31, 2021 and December 31, 2020.  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.

 

(m) LIQUIDITY––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 year endedcarrying 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 March 31, 2021 and December 31, 2016,2020, the Company incurred a net losscarrying value of $4,223,841 and used $2,950,938 of cash flows in its operations. At December 31, 2016, the Company had a cash balance of $960,197 and its current assets less current liabilities were $1,292,991. For the nine months ended September 30, 2017, the Company incurred a net loss of $2,448,993 and used net cash in operations in the amount of $2,076,426. At September 30, 2017, the Company had a cash balance of $1,342,642 and its current assets less current liabilities (excluding a $585,000 advance received from the private placement of stock that closed in October 2017) were $1,420,101. In October 2017, the Company generated additional net proceeds of $1,465,000, including the $585,000 received in September 2017, from the sale of equity securities in a private placement. The Company has concluded that proceeds from the private placement of its securities are currently the primary source of its cash flows that will permit the Company to meet its financial obligations as they come due through November 2018 despite its history of net losses. The Company continues to actively seek additional capital through the sale of its common stock. In the event that the Company cannot raise sufficient capital, management may be required to reduce its expenditures for clinical trials.  Further, if the Company is unable to raise sufficient capital in the near-term, the inability to do so could have a significant adverse effect on its future financial condition, results of operations, and cash flows.mortgage note receivable approximates fair value.

 

(n)(q) USE OF ESTIMATESESTIMATES––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.

 

(o) RECLASSIFICATIONS – Certain amounts in the 2016 financial statements have been reclassified to conform to the 2017 presentation. These reclassifications had no effect on previously reported net income or stockholders equity.

(p) NEW(r) RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS––The Financial Accounting Standards Board (FASB) hasManagement does not believe any recently issued, various Accounting Standards Updates (ASUs), including ASU 2014-09, Revenue from Contracts with Customers, as subsequently amended; ASU 2015-17, Income Taxes; and ASU 2016-02, Leases, which arebut not yet effective, in future fiscal years. We do not expect the adoption of theseaccounting standards, toif currently adopted, would have a material effect on the Company’s financial statements.

(s) 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 position orcondition 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.

9

CYCLO THERAPEUTICS, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

(1) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:  (CONTINUED)

(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.

Revenues by product are summarized as follows:

  

Three Months Ended

 
  

March 31,

 
  

2021

  

2020

 

Trappsol® Cyclo™

 $1,840  $30,096 

Trappsol® HPB

  201,348   214,962 

Trappsol® Fine Chemical

  142,495   78,109 

Aquaplex®

  11,276   - 

Other

  1,174   2,567 

Total revenues

 $358,133  $325,734 

Substantially all of our sales of Trappsol® Cyclo™ for the three months ended March 31, 2021 and year ended December 31, 2020 were to a single customer who exports the drug to South America. Substantially all of our Aquaplex® sales for the three months ended March 31, 2021 and year ended December 31, 2020 were to one customer.

(3) MAJOR CUSTOMERS AND SUPPLIERS:

Our revenues are derived primarily from chemical supply and pharmaceutical companies located primarily in the United States. For the three months ended March 31, 2021 five major customers accounted for 77% of total revenues. For the three months ended March 31, 2020, four major customers accounted for 70% of total revenues.

Substantially all inventory purchases were from three vendors in 2021 and 2020. 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 three months ended March 31, 2021, the product mix of our revenues consisted of 1% biopharmaceuticals, 96% basic natural and chemically modified cyclodextrins and 3% cyclodextrin complexes. For the three months ended March 31, 2020 the product mix of our revenues consisted of 9% biopharmaceuticals and 91% basic natural and chemically modified cyclodextrins.

10

CYCLO THERAPEUTICS, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

(4) MORTGAGE NOTE RECEIVABLE

 

On January 21, 2016, we sold our real property located in High Springs, Florida to an unrelated party. This property was previously classified on our balance sheet as property held for sale, with a carrying value of $275,000. 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’sbuyer’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) NOTE PAYABLE:

 

(3On 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 September 5, 2021. 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 believes it has used all of the loan proceeds for qualifying expenses, and plans to apply for forgiveness of the loan in accordance with the terms of the CARES Act.

(6) EQUITY TRANSACTIONS:

On December 8, 2020, the Company effected a 1-for-100 reverse split of its authorized and issued and outstanding shares of common stock. All share references have been restated for this reverse split to the earliest period presented. As a result of the split, the authorized shares of the Company’s common stock decreased to 10,000,000 shares.

 

The Company expensed $61,720$0 and $107,140$7,220 in employee and board member stock compensation for the three and nine months ended September 30, 2017, respectively, including with respect to 120,000March 31, 2021 and 2020, respectively. These shares of common stock issued to employees as bonus compensation.  The Company expensed $30,460 and $101,220 in employee and board member stock compensation for the three and nine months ended September 30, 2016, respectively.were valued using quoted market values. The Company accrues stock compensation expense over the period earned for employees and board members. On March 31, 2017,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. In 2020, the Company issued 172,000did not issue shares of common stock valuedfor compensation. The Company issued 53,938 shares to employees in January 2021 with a value of $271,308 at $67,100the time of issuance, with respect to eight board members and the Company’s secretarywhich compensation expense in that amount had been accrued as settlement of accrued stock compensation for prior service. 


CTD HOLDINGS, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2017December 31, 2020.

 

In October 2017,On April 24, 2020, the Company completed a private placement of 15,250 (“Units”) at a purchase price of $100 per Unit, each Unit consisting of one share of Series B Convertible Preferred Stock (“Preferred Stock”) convertible into 400 shares of common stock to a group of accredited investors that included several directors of the Company and seven-year warrants to purchase 400members of management. Investors in the private placement purchased a total of 200,000 shares of common stock at an exercisea price of $0.25$10 per share. The Preferred Stock will automatically convert into common stock on the dateshare, resulting in gross proceeds to the Company effects an increase of its authorized shares of common stock and/or a reverse stock split of its common stock, so that the Company has a sufficient number of authorized and unissued shares of common stock to permit the conversion or exercise, as applicable, of all outstanding shares of preferred stock, warrants and other convertible securities. The Preferred Stock has a liquidation preference of $100 per share, is not redeemable, and does not entitle the holder to special dividends. In the event the Company were to pay dividends on its common stock, holders of Preferred Stock would receive dividends based on the number of shares of common stock into which their shares of Preferred Stock are then convertible. Prior to September 30, 2017, the Company received a $585,000 advance from an investor in this private placement, which has been recorded as a current liability in the accompanying balance sheet. Subsequent to September 30, 2017, the investor was issued his Units and the Company reclassified the advance to stockholders’ equity.$2,000,000.

 

On February 23, 2017,August 27, 2020, the Company issued 5,754,832 units (“Units”) at a purchase price of $0.35 per Unit incompleted a private placement each Unit consistingof 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 283,111 units at a price of $10 per unit, resulting in gross proceeds to the Company of $2,831,114. Each unit consisted of one share of its common stock and a seven-year warrant to purchase an additionalone share of common stock at an exercise price of $0.35, for$15 per share.

On December 11, 2020, the Company sold an aggregate of 2,500,000 units at a price to the public of $5.00 per unit (the “Public Offering”), each unit consisting of one share of common stock, and a warrant to purchase one share of common stock at an exercise price of $5.00 per share (the “Warrants”), pursuant to an Underwriting Agreement we entered into with Maxim Group LLC (“Maxim”). In addition, pursuant to the Underwriting Agreement, the Company granted Maxim a 45-day option to purchase up to 375,000 additional shares of common stock, and/or 375,000 additional Warrants, to cover over-allotments in connection with the Offering, which Maxim partially exercised to purchase 375,000 Warrants on the closing date.

11

CYCLO THERAPEUTICS, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

(6) EQUITY TRANSACTIONS: (CONTINUED)

The Company received gross proceeds of $12,503,750 upon the initial closing of the Public Offering, before deducting underwriting discounts and commissions of eight percent (8%), and expenses. On December 22, 2020, the Company sold an additional 375,000 shares of common stock to Maxim upon its exercise of the balance of its over-allotment option, and received additional gross proceeds of $1,871,250 from such sale, bringing the total gross proceeds of the Public Offering to $14,375,000. The total expenses of the Public Offering were approximately $1,703,000 which included Maxim’s expenses relating to the offering.

Pursuant to the Underwriting Agreement, we issued warrants (the “Underwriter’s Warrants”) to Maxim to purchase 57,500 shares of common stock (2% of the shares of common stock sold in the Public Offering). The Underwriter’s Warrants are exercisable at $6.25 per share of common stock and have a term of five years.

Subsequent to the closing of the Public Offering through December 31, 2020, Warrants to purchase an aggregate of 197,000 shares of common stock were exercised, resulting in gross proceeds to the Company of $2 million. Scarsdale Equities LLC acted as financial advisor$985,000.

In January 2021, 10,000 shares of common stock with a value of $50,300 were issued to a nonemployee for services.

In February and March 2021 warrants issued in our December 2020 Public Offering were exercised to purchase an aggregate of 1,519,984 shares of common stock, resulting in gross proceeds to the Company of $7,599,920. 

In March 2021, warrants totaling 9,436 were exercised in connection witha net share settlement. This resulted in the private placementissuance of 2,913 shares of common stock and was paid a cash feethe expiration of approximately $153,000, and it and its designees were issued seven-year warrants to purchase 230,193 Units at an exercise price of $0.35 per Unit.6,523 in warrants.

 

As of September 30, 2017,March 31, 2021, the Company had warrants outstanding to purchase 14,332,3322,130,268 shares of common stock at exercise prices of $0.25$5.00 - $1.00$100.00 per share that expire inat various years until 2024.dates through 2027. In addition, there are seven-year warrants outstanding at September 30, 2017March 31, 2021 to purchase 710,1934,800 Units sold in our May 2016 private placement at an exercise pricesprice of $0.25-$0.35$25.00 per Unit, 1,641 Units sold in our February 2017 private placement at an exercise price of $35.00 per Unit, and 2,400 Units sold in our October 2017 private placement at an exercise price of $25.00 per Unit.

 

(4)(7) INCOME TAXES:

 

The Company reported a net loss for the three and nine months ended September 30, 2017March 31, 2021 and 2016,2020, respectively. The Company increased its deferred tax asset valuation allowance rather than recognize an income tax benefit.

(8) EQUITY INCENTIVE PLAN:

 

(5On 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”) SALES CONCENTRATIONS:. The Incentive Plan provides for the issuance of up to 68,437 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 March 31, 2021, we had awarded 68,437 shares of common stock as awards under the Incentive Plan, with no shares of common stock remaining available for future awards under the Incentive Plan.

(9) SUBSEQUENT EVENTS:

 

Sales to two major customers accounted for 59%The Company has evaluated subsequent events through the date these financial statements were issued and 55% of total sales forfiled with the threeSecurities and nine months ended September 30, 2017, respectively. Sales to two major customers accounted for 51%Exchange Commission, and 52% of total sales forhas determined that except as set forth below, there were no such events that warrant disclosure or recognition in the three and nine months ended September 30, 2016, respectively. A loss of one of these customers could have a significant adverse effect on the Company’s financial condition, results of operations and cash flows.

(6) SUBSEQUENT EVENT:

In October 2017, the Company completed the private placement disclosed in Note 3.statements

 


12

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, 2016.  2020.This report may contain forward-looking statements. Forward-looking statements within this Form 10-Q are identified by words such as “believes,believes, “anticipates,anticipates, “expects,expects, “intends,intends, “may,may, “will” “plans”willplans 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”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

 

CTD Holdings, Inc. (“we” “our” “us” or “the Company”) was organized as a Florida corporation on August 9, 1990, with operations beginning in July 1992. In conjunction with a restructuring in 2000, we changed our name from Cyclodextrin Technologies Development, Inc., or CTDI, to CTD Holdings, Inc.; CTDI was then incorporated as a Florida corporation and became a wholly owned subsidiary of CTD Holdings, Inc.

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, lung,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 describesdescribed 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 will evaluateevaluated 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 ™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 European Phase I/II study will evaluateis evaluating the safety, tolerability and efficacy of Trappsol® Cyclo™ along withthrough a range of clinical outcomes, including neurologic, hepatic, and respiratory, in addition to measurements of cholesterol metabolism and markers of NPC. The EuropeanEuropean/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.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 2017.2017, 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 our pivotal 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 we received a “Study May Proceed” notification from the FDA with respect to the proposed Phase III clinical trial. We currently estimate that in the event our pivotal Phase III trial proceeds as planned and provides further data supporting the safety and efficacy of Trappsol® Cyclo™ in the treatment of NPC, we may obtain regulatory approval of Trappsol® Cyclo™ as early as 2023.

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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 neurological and neurocognitive benefits and other clinical improvements in NPC patients. The full significance of these findings will be determined as part of the final analysis of these 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.

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 Alzheimer’s 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 that was presented to the FDA in January of 2021. We received feedback from the FDA on this synopsis in April 2021 and have incorporated the feedback into our development strategy for the filing of an IND for a Phase II program.  We intend to submit this IND to the FDA in the second half of 2021.

We filed an international patent application in October 2019 under the Patent Cooperation Treaty directed to the treatment of Alzheimer’s disease with cyclodextrins, and we expect to pursue one or more national or regional stage applications based on this international application.  The terms of any patents resulting from these national or regional stage applications would be expected to provide us with patent protection until 2039.

 

We also continue to selloperate 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 with continuing growth in research and new product development.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.

Substantially all of our revenues are derived from the sale of cyclodextrins, including bio-pharmaceuticals containing cyclodextrins, cyclodextrin complexes, resale of cyclodextrins manufactured by others for our clients to their specifications, and our own licensed cyclodextrin products.  We have trademarked certain products under our Trappsol®, Aquaplex®, and AP™-Flavor product lines.  We currently sell our products directly to customers in the diagnostics, pharmaceutical, and industrial chemical industries, and to chemical supply distributors.  


Trappsol® Cyclo™

At the end of 2008, we provided Trappsol® Cyclo™ to a customer for compassionate use as an Investigational New Drug to treat a set of twins in the U.S. who were diagnosed with NPC, also known as Childhood Alzheimer’s. NPC is a fatal disease caused by a genetic defect that prevents proper handling of cholesterol in the body’s cells. The patient’s treatment with our Trappsol® Cyclo™ product proved to provide an ameliorative benefit. On May 17, 2010, the FDA granted orphan drug status to our customer for Trappsol® Cyclo™ for the treatment of NPC. To date, Trappsol® Cyclo™ has been administered to approximately 20 NPC patients in compassionate use programs around the world, including in the U.S., Brazil, Spain and Norway. Our annual sales of Trappsol® Cyclo™ increased to $697,000 for 2016 from $352,000 for 2015. Sales of Trappsol® Cyclo™ were $331,000 and $401,000 for the nine months ended September 30, 2017 and 2016, respectively. In 2012, we began to offer 100ml vials of Trappsol® Cyclo™ in a liquid form from a contract manufacturer. In 2014, we completed validation of the Trappsol® Cyclo™ manufacturing process and submitted a Type II Drug Master File to the FDA. In 2015 we established an International Clinical Program that includes a team of experienced drug development companies and individuals. We have also obtained Orphan Drug Designation for Trappsol® Cyclo™ in both the U.S. and Europe.

Resale of Cyclodextrin and Cyclodextrin Complexes

Our sales of cyclodextrins and cyclodextrin complexes are primarily to chemical supply houses around the world, to pharmaceutical companies, to food companies for research and development and to diagnostics companies.

We acquire our products principally from outside the United States, including from Wacker Biosolutions, a division of Wacker Chemie AG (Germany), with a production facility located in Adrian, Michigan and Hangzhou Pharma and Chem Co. (China), Quian Hui (China), and Cyclodextrin Research & Development Laboratory (Hungary), but are gradually finding satisfactory supply sources in the United States. While we enjoy lower supply prices from outside the United States, changes in shipping costs and currency exchange rates are making domestic sources more competitively priced. We make patent information about cyclodextrins available to our customers. We also offer our customers our knowledge of the properties and potential new uses of cyclodextrins and complexes.

As most of our customers use our cyclodextrin products in their research and development activities, the timing, product mix, and volume of their orders from us are unpredictable. We also have four large customers (each of whom has historically purchased from us annually and, depending upon the year, may account for greater than 10% of our annual revenues) who have a significant effect on our revenues when they increase or decrease their research and development activities that use cyclodextrins. We keep in constant contact with these customers as to their cyclodextrin needs so we can maintain the proper inventory composition and quantity in anticipation of their needs. The sales to large customers and the product mix and volume of products sold has a significant effect on our revenues and product margins. These factors contribute to our revenue volatility from quarter to quarter and year to year.

Liquidity and Capital Resources

Our cash increased to $1,343,000 as of September 30, 2017, compared to $960,000 as of December 31, 2016. Our current assets less current liabilities (excluding a $585,000 advance received from our private placement of stock that closed in October 2017) were $1,420,101. We used $2,076,000 in operations for the nine months ended September 30, 2017, compared to $2,387,000 for the same period in 2016. We repaid all of our bank debt in December 2016 with proceeds from the sales of our real property and manufacturing facility.

In October, 2017, we received net proceeds of $1,465,000, including the $585,000 received in September 2017, from the sale of our equity securities in a private placement.


We plan to use our available cash primarily for the development of our Trappsol® Cyclo™ orphan drug product, including implementation of our International Clinical Program and U.S. clinical trials and designs, and other general corporate purposes.

We presently believe the Company has sufficient cash to meet its anticipated operating costs and capital expenditure requirements for at least the next twelve months. 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.

We have no off-balance sheet arrangements at September 30, 2017.

 

Results of Operations - Three and NineMonths Ended MarchSeptember 30, 201731, 2021 Compared to Three and NineMonths Ended MarchSeptember31, 2020 30, 2016

 

We reported a net loss of $(634,000) and $(2,449,000)approximately $4,037,000 for the three and nine months ended September 30, 2017, respectively,March 31, 2021, compared to a net loss of $(1,615,000) and $(3,392,000)approximately $2,634,000 for the three and nine months ended September 30, 2016, respectively.  March 31, 2020.

 

Total revenues for the three monthmonth period ended September 30, 2017 decreased 13%March 31, 2021 increased 10% to $241,000approximately $358,000 compared to $278,000approximately $326,000 for the same period in 2016. Total revenues for the nine month period ended September 30, 2017 increased 10% to $1,069,000 compared to $975,000 for the same period in 2016.

2020. Our change in the mix of our product sales for the three and nine months ended September 30, 2017March 31, 2021 and 20162020 is as follows:

 

Trappsol® Cyclo

Our salesSales of Trappsol® Cyclo™ decreased by 20%94% for the three month period ended September 30, 2017,March 31, 2021 to $17,000$2,000 from $21,000approximately $30,000 for the three month period ended September 30, 2016.  OurMarch 31, 2020. Substantially all of our sales of Trappsol® Cyclo™ decreased by 18% for the nine month periodthree months ended September 30, 2017, to $331,000 from $401,000 for the nine month period ended September 30, 2016. We had no salesMarch 31, 2021 and 2020 were to a particular customer who exports Trappsol® Cyclo™the drug to South America for the three months ended September 30, 2017, compared to $21,000 (100% of total sales of Trappsol® Cyclo™) for the three months ended September 30, 2016; and our sales to that same customer who exports Trappsol® Cyclo™ to South America were $287,000 (87% of total sales of Trappsol® Cyclo™) for the nine month period ended September 30, 2017, compared to $386,000 (96% of total sales of Trappsol® Cyclo™) for the nine month period ended September 30, 2016.America. Our annual 20162020 sales to this customer were $669,000 (96%approximately $104,000 (100% of total 20162020 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 and while we expect our future sales to increase, the timing of sales will be unpredictable and our ability to market the drug for use other than research is severely constrained by regulatory restrictions in the applicable jurisdictions.  small.  

 

Trappsol® HPB

Our sales of Trappsol® HPB increaseddecreased by 5%6% for the three month period ended September 30, 2017,March 31, 2021, to $171,000approximately $201,000 from $163,000approximately $215,000 for the three months ended September 30, 2016. Our sales of Trappsol® HPB increased by 50% for the nine month period ended September 30, 2017, to $595,000 from $397,000 for the nine month period ended September 30, 2016.March 31, 2020.

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Trappsol® other products

Our sales of other Trappsol® other products decreasedincreased by 2%82% for the three month period ended September 30, 2017,March 31, 2021, to $34,000approximately $142,000 from $35,000approximately $78,000 for the three month periodmonths ended September 30, 2016. Our sales of other Trappsol® products increased by 36% for the nine month period ended September 30, 2017, to $103,000 from $75,000 for the nine month period ended September 30, 2016.March 31, 2020.

 

Aquaplex®

There were negligibleOur sales of Aquaplex® for the three month periodperiods ended September 30, 2017 compared to $57,000March 31, 2021 were approximately $11,000. We had no sales of Aquaplex® for the three month periodmonths ended September 30, 2016. Our sales of Aquaplex® were $18,000 for the nine month period ended September 30, 2017 compared to $78,000 for the nine month period ended September 30, 2016.March 31, 2020.

 


OurThe 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 ninethree months ended September 30, 2017,March 31, 2021, our twofive largest customers accounted for 55%77% of our sales; the largest accounted for 29%24% of sales. During the ninethree months ended September 30, 2016,March 31, 2020, our twofour largest customers accounted for 52%70% of our sales; the largest accounted for 41%28% 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) as a percentage of sales for the ninethree month period ended September 30, 2017 was 11% ($118,000) comparedMarch 31, 2021 increased 31% to 13% ($124,000)approximately $35,000 from approximately $26,000 for the same period in 2016.2020. Our cost of products sold (excluding any allocation of direct and indirect overhead and handling costs) as a percentage of sales was 8% ($20,000)10% for the three months ended September 30, 2017 compared to 11% ($31,000)March 31, 2021 and 8% for the same period in 2016.three months ended March 31, 2020. 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 2016 or 2015,2020, or the first ninethree months of 2017.2021.

 

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. We have threeOur employees who provide receiving, inspection, warehousing and shipping operations for us. The cost of theseour employees and our other employees, areis included in personnel expense. Our other costs of warehousing and shipping functions are included in office and other expense.

 

As we buy most of ourinventory from foreign suppliers, the change in the value of the U.S. dollar in relation to the Euro, Yen and Yuan has had and will continue to 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. The cost of shipping from outside the U.S. also has a significant effect on our inventory acquisition costs. When we experience short-term increases in currency fluctuation 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 decreasedincreased by 19%, to $269,000approximately $559,000 for the three months ended September 30, 2017March 31, 2021 from $328,000approximately $470,000 for the three months ended September 30, 2016. Personnel expenses decreased to $908,000 for the nine months ended September 30, 2017 from $1,010,000 for the nine months ended September 30, 2016.March 31, 2020. The decreaseincrease in personnel expense is due to our reductionChief Financial Officer moving from part-time to full-time employment with us at the end of 2020. We expect to maintain our level of employees and related costs in personnel in conjunction with the sale of our office and manufacturing facility in December 2016.near term.

 

Research and development expenses increased 58% to $339,000approximately $3,258,000 for the three months ended September 30, 2017,March 31, 2021, from $311,000approximately $2,059,000 for the three months ended September 30, 2016. Research and development expenses increased to $1,509,000 for the nine months ended September 30, 2017, from $1,255,000 for the nine months ended September 30, 2016.March 31, 2020. Research and development expenses as a percentage of our total operating expenses increased to 43%74% for the ninethree months ended September 30, 2017March 31, 2021 from 29%69% for the ninethree months ended September 30, 2016.March 31, 2020. The increase in research and development expense is due to theincreased activity in our International Clinical Program.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.NPC and Alzheimer’s disease.

 

Repairs and maintenance expenses decreasedProfessional fees increased 2% to $1,000approximately $223,000 for the three months ended September 30, 2017 from $3,000March 31, 2021, compared to approximately $220,000 for the three months ended September 30, 2016. RepairsMarch 31, 2020. Professional fees may increase in the future due to new initiatives in raising capital and maintenance expenses decreased to $5,000 for the nine months ended September 30, 2017 from $19,000 for the nine months ended September 30, 2016.continuation of product development.

 

Professional fees decreasedOffice and other expenses increased 76% to $116,000approximately $314,000 for the three months ended September 30, 2017,March 31, 2021, compared to $176,000approximately $178,000 for the three months ended September 30, 2016. Professional fees increasedMarch 31, 2020 due primarily to $542,000 for the nine months ended September 30, 2017, compared to $455,000 for the nine months ended September 30, 2016. Professional fees mayan increase as we increase our capital raising initiatives and seek to develop new products.

Office and other expenses decreased to $112,000 for the three months ended September 30, 2017 compared to $171,000 for the three months ended September 30, 2016. Office and other expenses decreased to $338,000 for the nine months ended September 30, 2017 compared to $479,000 for the nine months ended September 30, 2016.

Board of Directors fees and costs decreased to $18,000 for the three months ended September 30, 2017, compared to $53,000 for the three months ended September 30, 2016. Board of Directors fee and costs decreased to $95,000 for the nine months ended September 30, 2017, compared to $100,000 for the nine months ended September 30, 2016.in investor relations costs.

 


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Depreciation was $2,000 for the three months ended September 30, 2017, compared to $4,000 for the three months ended September 30, 2016. Depreciation was $7,000 for the nine months ended September 30, 2017, compared to $92,000 for the nine months ended September 30, 2016. This decrease is due to the sale of our office and manufacturing facility in December 2016. Our depreciation expense for future periods will be consistent with the current expense.

We had no interest expense in the three and nine months ended September 30, 2017, compared to $7,000 and $22,000 for the three and nine months ended September 30, 2016 due to the repayment of our bank debt in December 2016.


 

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 three and nine months ended September 30, 2017,March 31, 2021, and 2016,2020, respectively.

Liquidity and Capital Resources

Our cash increased to approximately $15,507,000 as of March 31, 2021, compared to approximately $12,846,000 as of December 31, 2020. Our current assets less current liabilities were approximately $14,314,000 as of March 31, 2021, compared to approximately $10,422,000 at December 31, 2020. Cash used in operations was approximately $4,927,000 for the three months ended March 31, 2021, compared to approximately $1,809,000 for the same period in 2020. 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. 

In April 2020, we completed a private placement in which we raised $2,000,000 from the sale of 200,000 shares of Common Stock, at a price $10.00 per share, and in August 2020, we completed a private placement in which we raised an additional approximately $2,831,000 from the sale of 283,111 units at a price of $10.00 per unit, each unit consisting of one share of Common Stock and a seven-year warrant to purchase one share of Common Stock at an exercise price of $15.00 per share.

We also borrowed approximately $158,000 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 December 11, 2020 we sold an aggregate of 2,500,000 units at a price to the public of $5.00 per unit (the “Public Offering”), each unit consisting of one share of our Common Stock, and a warrant to purchase one share of Common Stock at an exercise price of $5.00 per share (the “Warrants”), pursuant to an Underwriting Agreement we entered into with Maxim Group LLC (“Maxim”). In addition, pursuant to the Underwriting Agreement, we granted Maxim a 45-day option to purchase up to 375,000 additional shares of Common Stock, and/or 375,000 additional Warrants, to cover over-allotments in connection with the Offering, which Maxim partially exercised to purchase 375,000 Warrants on the closing date.

We received gross proceeds of $12,503,750 upon the initial closing of the Public Offering, before deducting underwriting discounts and commissions of eight percent (8%), and expenses. On December 22, 2020, we sold an additional 375,000 shares of Common Stock to Maxim upon its exercise of the balance of its over-allotment option, and received additional gross proceeds of $1,871,250 from such sale, bringing the total gross proceeds of the Public Offering to $14,375,000. The total expenses of the Public Offering were approximately $1,703,000 which included Maxim’s expenses relating to the offering.

Pursuant to the Underwriting Agreement, we issued warrants (the “Underwriter’s Warrants”) to Maxim to purchase up to a total of 57,500 shares of Common Stock (2% of the shares of Common Stock sold in the Public Offering). The Underwriter’s Warrants are exercisable at $6.25 per share of Common Stock and have a term of five years.

Subsequent to the closing of our December 2020 Public Offering through March 31, 2021, Warrants to purchase an aggregate of 1,716,984 shares of Common Stock were exercised resulting in gross proceeds to the Company of approximately $8,569,000.

The Company has continued to realize losses from operations. However, as a result of our Public Offering, we believe we will have sufficient cash to meet our anticipated operating costs and capital expenditure requirements for at least the next 12 months.  We will need to raise additional capital in the future to support our ongoing operations and continue our clinical trials.  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.

At December 31, 2020, we had approximately $25,168,000 in net state and federal operating loss carryforwards expiring from 2021 through 2037, including $17,000,000 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. 

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We had no off-balance sheet arrangements as of March 31, 2021.

Critical Accounting Policies and Estimates

Our discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S. The preparation of these financial statements requires us to make judgments, estimates, and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements as well as the reported revenue and expenses during the reporting periods. We continually evaluate our judgments, estimates and assumptions. We base our estimates on the terms of underlying agreements, our expected course of development, historical experience and other factors we believe are reasonable based on the circumstances, the results of which form our management’s basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

There were no significant changes to our critical accounting policies during the quarter ended March 31, 2021. For information  about critical accounting policies, see the discussion of critical accounting policies in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020.

 

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 quarterly report (the "Evaluation Date"). Based on such evaluation, our principal executive officer and principal financial officer hashave concluded that as of the Evaluation Date, our disclosure controls and procedures are effective.were effective as of March 31, 2021.

 

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.

 


17

 

PART II. OTHER INFORMATION

 

Item 1A. Risk Factors.

 

We have identified no additional risk factors other than those included in Part I, Item 1A of our Annual Report on Form 10-K for the fiscalour year ended December 31, 2016.2020 that we filed with the Securities and Exchange Commission on March 12, 2021.  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.

 

EXHIBIT

NO.

DESCRIPTION

3.1

Articles of Incorporation of Cyclo Therapeutics, Inc., a Nevada corporation (incorporated by reference to Exhibit 3.1 to the Companys Current Report on Form 8-K filed with the Securities and Exchange Commission on November 10, 2020).

3.2

Bylaws of Cyclo Therapeutics, Inc., a Nevada corporation (incorporated by reference to Exhibit 3.2 to the Companys Current Report on Form 8-K filed with the Securities and Exchange Commission on November 10, 2020).

31.1

Rule 13a-14(a)/15d-14a(a) Certification of Chief Executive Officer

31.2

Rule 13a-14(a)/15d-14a(a) CertificationsCertification of Chief Financial Officer

32.1

Section 1350 CertificationsCertification of Chief Executive Officer

32.2

Section 1350 Certification of Chief Financial Officer

   

101.INS

XBRL Instance Document

101.SCH

XBRL Taxonomy Extension Schema Document

101.CAL

XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF

XBRL Taxonomy Extension Definition Linkbase Document

101.LAB

XBRL Taxonomy Extension Label Linkbase Document

101.PRE

XBRL Taxonomy Extension Presentation Linkbase Document

 


18

 

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.

 

CTD HOLDINGS,CYCLO THERAPEUTICS, INC.

Date:  November 9, 2017   May 14, 2021

By:

/s/ N. Scott Fine 

N. Scott Fine

Chief Executive Officer

(principal executive officer)

Date:  May 14, 2021

By:

/s/ Joshua M. Fine

Joshua M. Fine

Chief Financial Officer

(principal financial and accounting officer)

 

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